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how many critical elements are included for prioritization to be successful ?

jzbn0226

jzbn0226_p24, jzbn0226_p25, jzbn0226_p26

three

C. Waivers EPA has proposed that all comments that could be raised on issues in a proposed low priority designation be presented during the comment period, and that any issues not raised then be considered to have been waived. Waived issues could not form the basis of an objection or challenge in any subsequent administrative or judicial proceeding on the designation of the substance as a low priority substance (which is subject to judicial review). EPA points to the statutory deadlines in the prioritization process as the policy justification for this proposal. 38 ACC urges EPA to remove this waiver requirement from the prioritization rule. First, it is inconsistent with Congress's intent that the prioritization process be iterative and science-based. Low priority designations should be able to be modified - expanded or contracted - based on new information that is brought to the Agency's attention after the designation. This new information might not have been known during the public comment period on the low priority designation. It would be bad public policy to consider new information waived because that could discourage stakeholders from gathering or developing relevant information about a chemical. Second, participation in the notice and comment rulemaking process of prioritization is governed by statute - through the Administrative Procedures Act (APA) and the judicial review provisions of Section 19 of TSCA. There are no issue exhaustion provisions in TSCA. EPA cannot by regulation, impose an issue exhaustion requirement that trumps the statutory rights and obligations of stakeholders under the APA and TSCA Section 19.39 D. Definitions As an addendum to ACC's recommendations for EPA to reference the Section 26 science standards in the prioritization process rule, ACC offers the following definitions for EPA's consideration: Best available science means information that has been evaluated based on its strengths, limitations and relevance and the Agency is relying on the highest quality information. In evaluating best available science the Agency will also consider the peer review of the science, whether the study was conducted in accordance with sound and objective practices, and if the data were collected by accepted methods or best available methods. To ensure transparency regarding best available science the Agency will describe and document any assumptions and methods used, and address variability, uncertainty, the degree of independent verification and peer review. Weight of the evidence means a systematic review method that uses a pre-established protocol to comprehensively, objectively, transparently, and consistently, identify and evaluate each stream of evidence, including strengths, limitations, and relevance of each study and to integrate evidence as necessary and appropriate based upon strengths, limitations, and relevance. 38 Id. at 4833. 39 See ACC Comments on EPA's Proposed Rule: Procedures for Chemical Risk Evaluation under the Amended Toxic Substances Control Act (RIN 2070- AK20) for additional discussion of the waiver/lock down/issue exhaustion issue. 23 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 E. Repopulation of High Priority Substances EPA's preamble discussion of the "repopulation" of high priority substances40 presents a reasonable approach by which the Agency could meet the LCSA obligation to finalize the designation of one new high priority substance upon completion of a risk evaluation for another substance. The one-for-one approach makes sense as this program gets underway. ACC suggests, however, that EPA consider a placeholder in its rule to anticipate changes in the rate at which EPA might be able to conduct risk evaluations over time (based on use of 21st Century tools and methods) and hence potentially change the rate at which EPA may need to designate high priorities for risk evaluation. VIII. Summary of ACC's Recommendations: Throughout these comments, ACC has included many specific recommendations for EPA to consider as it develops its final prioritization process rule to address ACC's concerns about the proposed rule. These recommendations urge EPA to direct its authority on what it is mandated to do under the LCSA - designate high priority and low priority chemicals for risk evaluations in accordance with both the criteria in LCSA Section 6 and the LCSA Section 26 science based standards. To help the regulated community provide EPA the information the Agency will need to prioritize chemicals for risk evaluations, EPA must clarify the prioritization process as a whole and develop an efficient and focused prioritization process rule that meets the LCSA mandate and Congressional intent. ACC strongly urges EPA to amend its proposal to include these suggested recommendations and seek public comment before finalizing the prioritization process rule. Alternatively, EPA should propose a supplemental rule providing more detail and clarifications on the prioritization process steps involved and finalize it prior to the Agency's first application of the prioritization process . To help foster the submission of information needed to prioritize chemicals for risk evaluations, EPA must ultimately develop an efficient and focused prioritization process rule that clearly lays out the major steps for meeting its mandate. 40 82 Fed. Reg. at 4833. 24 Source: :ttps://www.industrydocuments.ucsf.edu/docs/jzbn0226 Attachment A ACC's General Principles on Prioritization (Developed for EPA Dialogue 7-2011) EPA should systematically prioritize chemicals for purposes of safe use determinations. As a general matter, prioritization should be based on existing hazard and exposure data and information (including models, read across, QSAR, etc.) and industry should be responsible for providing EPA with this data and information. Chemicals lacking adequate hazard and exposure information should be considered a higher priority (until relevant information is provided that suggests otherwise). Industry should be provided an opportunity to provide EPA additional data/information. (Timing is an issue, however. And the format in which the information is provided to EPA must be useable/digestible by EPA, e.g. robust summaries.) Hazard, use and exposure based criteria should be integrated to form the basis for EPA's prioritization decisions. Prioritization should not be based on either hazard-only or exposure-only information. The prioritization process and science based criteria that EPA uses to prioritize chemicals must be transparent. Prioritization should be a dynamic, iterative process. Re-examination of priorities should occur as new information becomes available and as new chemicals are approved for manufacturing. For prioritization to be successful, it must include three critical elements: reliable and up- to- date chemical data and information; evaluation criteria that consider both hazard and exposure information together; and established cutoffs to make priority decisions. EPA's communication about priority chemicals must be clear about what the list is and what it is not, to avoid unintended consequences of product de-selection purely on the basis of listing. Transparency; consistent, scientific criteria; intersection of both hazard and exposure information; dynamic process so new information can be incorporated as it is made available and so if priorities are initially "wrong" they can be corrected. 25 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226

What is the fullform of ACC?

ylcn0226

ylcn0226_p0, ylcn0226_p1, ylcn0226_p2, ylcn0226_p3, ylcn0226_p4, ylcn0226_p5, ylcn0226_p6, ylcn0226_p7, ylcn0226_p8, ylcn0226_p9

The American Chemistry Council, American Chemistry Council

Search 1/19/17 snapshot Assessing and Managing Chemicals under TSCA Contact Us Share Assessing and Managing Chemicals under The Frank R. Lautenberg TSCA Home Chemical Safety for the How EPA Assesses Chemical Safety 2 1st Century Act Assessments for TSCA Work Plan Chemicals On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for Sign up for Current Chemical the 21st Century Act which amends the Toxic TSCA and Risk Reduction Activities Other Substances Control Act (ISCA), the Nation's Chemical ChemView primary chemicals management law. Safety News Chemical Data Reporting The new law, which received bipartisan support in both the U.S. House of Representatives and Getemail alerts the Senate, includes much needed improvements such as: Enter email address sign up Mandatory requirement for EPA to evaluate existing chemicals with clear and enforceable deadlines; New risk-based safety standard; Increased public transparency for chemical information; and Recent Consistent source of funding for EPA to carry additions out the responsibilities under the new law. Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 American" Chemistry Council August 24, 2016 Wendy Cleland-Hamnett Director, Office of Pollution Prevention and Toxics Environmental Protection Agency 1200 Pennsylvania Ave. NW Washington, DC 20460-0001 Sent electronically to www.regulations.gov docket # EPA-HQ-OPPT-2016-0400 Re: ACC Comments to Inform EPA's Rulemaking on the Conduct of Risk Evaluations under the Lautenberg Chemical Safety Act Dear Ms. Cleland-Hamnett: The American Chemistry Council (ACC¹ appreciates the opportunity to provide input to the Office of Pollution Prevention and Toxics to inform the Agency's development of a risk evaluation rulemaking under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (LCSA). ACC has a long-standing commitment to a robust, science-based approach to evaluation of human and environmental risk. ACC is committed to the effective implementation of the LCSA and supports a workable, rigorous process that allows for timely, high quality reviews. Given the strong emphasis on a risk-based approach in the LCSA, the Section 6(b)(4) rulemaking is particularly important because it will guide the conduct of future risk evaluations that will then inform risk management activities. ACC is committed to being a constructive stakeholder throughout the implementation of LCSA. We will continue to draw from the breadth and depth of our member companies' expertise to ensure that our recommendations are not only science-based, but also allow for the efficient and effective implementation of the LCSA. In doing so, ACC will continue to consider the high quality science standards in the LCSA as well as the timeframes and deadlines imposed therein. The enclosed recommendations were developed with these important considerations in mind. If EPA has any questions, please contact me at nancy [email protected] or 202-249-6417. Sincerely, Nancy B. Beck, PhD, DABT Senior Director, Regulatory and Technical Affairs Cc: Jim Jones, OCSPP Assistant Administrator Louise Wise, Deputy Assistant Administrator Jeffery Morris, Deputy Director for Programs, OPPT Tala Henry, Director, Risk Assessment Division, OPPT 1 The American Chemistry Council (ACC) represents the leading companies engaged in the business of chemistry. More information about ACC is presented in the body of our comments. 1 IPage Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 American Chemistry Council Initial Input to U.S. Environmental Protection Agency In Regard to the Risk Evaluation Rule under the Lautenberg Chemical Safety Act Table of Contents I. Introduction and Executive Summary 4 II. The Risk Evaluation Rulemaking Must Include both Procedural And Substantive Elements to Effect the Purposes of the Statute 5 III. The Proposed Rule Should Include a Tiered Approach to Risk Evaluation 6 IV. The Rule Should Clarify the Process for Preparation and Contents of the Scope 8 V. The Proposed Rule Should Include a Detailed Description of Substantive Elements of Risk Evaluation 8 VI. Proposed Rule Should Ensure Consistency with Section 6(b)(4)(F) 9 a. Integration and Assessment of Information Relevant to Risks and Information on Potentially Exposed and Susceptible Populations 10 i. Conditions of Use That are Relevant 10 ii. Potentially Exposed or Susceptible Subpopulations 10 b. Aggregate and Sentinel Exposures 12 i. Aggregate Exposures 12 ii. Sentinel Exposures 12 c. Exposure Assessment 13 d. Weight of the Evidence 14 VII. The Proposed Rule Should Incorporate Section 26(h) Scientific Standards 14 a. Fit-for-Purpose Approach 15 b. Consideration of Relevant Information 16 i. Improving Hazard Assessment 16 ii. Improving Dose Response Assessment 17 iii. Reliance on Guidance 17 c. Importance of High Quality Risk Characterization 18 d. Clearly Addressing Variability and Uncertainty 18 e. Ensuring Appropriate Peer Review and Forming a Science Advisory Committee on Chemicals 19 21 Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 VIII. The Proposed Rule Should Implement a Weight of the Scientific Evidence (WoE) Approach 20 a. Systematic Review is Required 20 i. Development of a Protocol 21 ii. Search Strategy 21 iii. Transparency 21 b. A Systematic Review is Not Automatically a WoE Assessment 21 c. WoE and Systematic Review for Screening Level Risk Evaluations 22 d. WoE and Systematic Review for Refined Risk Evaluations 22 e. Strength of Evidence is Not the Same as WoE 23 IX. EPA Should Make Information Available Consistent with Section 26(j) 24 X. EPA Should Use Reasonably Available Information and CBI Consistent with Section 26(k) 24 XI. EPA Should Utilize Fit-for-Purpose Exposure Evaluation Tools 25 XII. The Requirements of Sections 6 and 26 Apply to Environmental Risk Evaluations 26 a. Advancing Models for Environmental Risks 27 b. Improving Data Sourcing, Generation, and Evaluation 27 c. Persistent, Bioaccumulative and Toxic (PBT) Substances 28 XIII. EPA Should Leverage International and Inter-Agency Cooperation 28 XIV. Incorporating High Throughput Tools and Alternative Methods 29 XV. Stakeholders and EPA Must Be Held to the Same High Standard 30 APPENDIX A: ACC's Principles for Improving Chemical Hazard and Risk Assessment 31 APPENDIX B: Improving Hazard Assessment 32 APPENDIX C: Improving Does Response Assessment 33 APPRNDIX D: Improving Risk Characterization 35 APPENDIX E: Ensuring Robust Peer Review 37 APPENDIX F: Exposure Modeling Tools 39 APPENDIX G: Additional Information on the ECETOC TRA 41 3 I P a 3 e Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 I. Introduction and Executive Summary The American Chemistry Council (ACC)2 is pleased to provide the U.S. Environmental Protection Agency (EPA) this initial input on the Lautenberg Chemical Safety Act's (LCSA) requirement for the Agency to establish, by rule, the process for conducting risk evaluations. ACC appreciates EPA's early efforts to obtain input from stakeholders at its August 9, 2016, public meeting. We also appreciate EPA's solicitation of written comments to be entered into the docket, well in advance of publication of the proposed rule. Our comments both clarify, as well as supplement and expand upon, the oral comments we presented at the August 9 meeting. ACC strongly supported Congress' efforts to update and reform the Toxic Substances Control Act (TSCA). We believe that high quality risk evaluation, using best available science and weight of the evidence (WoE), is at the very heart of the LCSA. Effective and efficient risk evaluations will help deliver the results intended by Congress. Section 6(b)(4)(B) of the statute requires EPA to establish, by rule, "a process to conduct risk evaluations.' This certainly should include a description of the sequence of events, timelines, opportunities for public comments and peer review. Both Sections 6 and 26 of the LCSA outline various substantive elements that apply to and inform risk evaluation. A risk evaluation must: Be conducted in a manner designed to determine "whether a chemical substance presents an unreasonable risk of injury to health or the environment;" as set out in Section 6(b)(4)(A); Identify whether there exists "an unreasonable risk to a potentially exposed or susceptible subpopulation." EPA must identify potentially exposed or susceptible subpopulations relevant to the risk evaluation under conditions of use; Address the specific elements set out in Section 6(b)(4)(F); and Comply with the specific requirements of Section 26, including the best available science, weight of the evidence, and transparency requirements. Because these elements are at the core of the risk evaluation process, and affect risk management measures, they are substantive and should be described in adequate detail in the regulation. In general, where risk evaluation elements are now required by statute, EPA should apply them uniformly and universally reflecting them in the body of the regulation. The recommendations provided by ACC in these comments address screening and refined risk evaluations and are meant to apply to both human health and environmental risks. Specific tools, testing methods, databases, and the like may develop over time, or course, and can be updated as necessary in policies, 2 The American Chemistry Council (ACC) represents the leading companies engaged in the business of chemistry. ACC members apply the science of chemistry to make innovative products and services that make people's lives better, healthier and safer. ACC is committed to improved environmental, health and safety performance through Responsible Care common sense advocacy designed to address major public policy issues, and health and environmental research and product testing. The business of chemistry is a $797 billion enterprise and a key element of the nation's economy. It is the nation's largest exporter, accounting for fourteen percent of all U.S. exports. Chemistry companies are among the largest investors in research and development. Safety and security have always been primary concerns of ACC members, and they have intensified their efforts, working closely with government agencies to improve security and to defend against any threat to the nation's critical infrastructure. 4 Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 procedures and guidance. Our comments strive to make these differentiations and explain where particular elements of risk evaluation should be included in the rule proper. Specifically, our recommendations suggest definitions, and procedural steps and elements that will allow EPA to ensure that risk evaluations are consistent with the statutory requirements for EPA to use the best available science and WoE approaches. The recommendations also include definitions and procedural steps are not expected to change over time. ACC has referenced each of our suggestions to an existing EPA guidance, a National Academies (NAS) report, or another authoritative body or peer reviewed report. For instance, the recommendations in EPA's 2000 Risk Characterization Handbook still represent best practices today. Adding adequate definitions and explanation to the rule is particularly important to achieving incorporation of statutory requirements. We also note that in addition to Section 6, Sections 26(h), 26(i), 26(j), and 26(k) of the LCSA each present legal requirements that are applicable to the risk evaluation. EPA will now need to provide a level of transparency regarding not only the inputs, but also the methods of the analysis, including clear descriptions of uncertainties and variability. EPA should leverage information from other jurisdictions where data and information is applicable and of sufficient quality to meet the science standards in the LCSA. Incorporating these elements into the rulemaking creates a better platform for clear and consistent articulation of the Agency's understanding of statutory requirements, and will better support consistent and uniform application of the elements of risk evaluation. It is critically important that EPA engage the public as EPA plans, scopes, and conducts risk evaluations. Industry scientists often have unique insight and experience with their companies' chemistries and collectively have a large body of knowledge of risk assessment processes globally, including an understanding of potential human health and environmental impacts. ACC encourages EPA to leverage this knowledge and engage early (well before draft risk evaluations are released) and frequently with industry throughout the risk evaluation process. II. The Risk Evaluation Rulemaking Must Include both Procedural and Substantive Elements to Effect the Purposes of the Statute Congress included a specific mandate to EPA to establish a risk evaluation rulemaking. There is little question that the rule must describe the process by which risk evaluations will be conducted. However, to 3 effect the purposes of the statute, the process described in the rule cannot merely set out timelines or the sequence of the risk evaluation. It must include a clear articulation of the substantive elements of risk evaluation, and more particularly, it must explain how it will apply the principles set out in Section 6(b)(4)(F), Section 26, and other parts of the statute. If Congress had intended the scientific standard of "best available science" or "weight of the scientific evidence" to be incorporated into guidance alone, it would have included them only in Section 26(1) on "policies, procedures and guidance." 3 "[T]he Administrator shall establish, by rule, a process to conduct risk evaluations in accordance with subparagraph (A) " Section 6(b)(4)(A). 5 I Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 The very purpose of the risk evaluation is to develop the evidentiary and scientific basis to enable EPA to complete the risk determination required by statute. That risk determination has substantive impact - it significantly affects conduct, activity or a substantive interest that is the subject of agency regulation. The determination following risk evaluation is a necessary prerequisite for a chemical to proceed to risk management, if warranted. The rule should thus include a clear description of how EPA will undertake risk evaluations in order to meet the new statutory requirements of the LCSA. This includes a description of the scoping process and requirements for a published scope as well as the elements of the risk evaluation itself and the mechanism for gauging adequacy as measured against statutory criteria. III. The Proposed Rule Should Include a Tiered Approach to Risk Evaluation We believe the statute contemplates a tiered approach to risk evaluation and recommend that EPA include a tiered approach in the rule. Under the LCSA, EPA must initiate the risk evaluation "upon designating" a chemical as a high-priority substance. The scope, however, is not required to be published "upon initiation" -- EPA has up to six months following the initiation of the risk evaluation to prepare and publish the scope. Congress intended this six month period to be used for a scoping exercise, where EPA identifies "the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations the Administrator expects to consider in the risk evaluation." This six month period is a "step" between the high priority designation and the publication of the scope. In order for EPA to conduct risk evaluations consistent with the quality required by the LCSA and within the timeframes required, EPA should conduct a screening level evaluation during the scoping phase. During the scoping phase of risk evaluations, tools exist to allow EPA to conduct quantitative screening level analyses of multiple exposure scenarios, as appropriate for consumers, sensitive subpopulations, and the environment. This will allow EPA to have a more tailored focus on those populations and exposures of greatest concern during a refined risk evaluation process. Figure 1 below depicts ACC's recommended approach. 6 I Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 - y 10 Worknlan High-Duality Refined Risk Evaluation High Pricrity Chemicats & DRAFT Chemicals Manufacturer Risk Evaluation Requested EXPOSSURES HAZARD Evaluation incorporating Sections 6 and 26 of the Lautenberg Chemicel Safety Act (LCSA): Scope/Screening Level Risk Evatuation Scientific Standards FINAL Susceprible Weight of Scientific Evidence Evaluations Risk Evaluation Exposures Pupulations or use Certain Conditions of Use Present Do not present an anreasonable risk an unreasonable risk Refined No further risk evaluation risk avaluation No further action; needed RUREMAKING PROCESS COMPLETE the Figure 1. A Two-Step Process for Conducting Risk Evaluations Note: This is a simplified version of the process. A tiered approach, where EPA uses the scoping step (step 1) to conduct a quantitative screening level analysis, will allow EPA to focus its limited resources on more robust refined risk evaluations for only those conditions of use where unreasonable risks cannot be ruled out. Screening-level assessments require less data and information, and are typically deterministic and based on conservative, health protective assumptions and methods. When a screening assessment indicates low risk for a particular condition of use, the Agency should have a high degree of confidence that the potential risks are much lower than the calculation and, therefore, the actual risks are lower and/or perhaps non-existent. However, when a screening-level risk assessment indicates a potential concern for an adverse effect, this does not mean that the actual risks are significant and warrant action. Rather, it indicates the Agency should take a second step in the risk evaluation process to refine the evaluation to more accurately quantify potential risks. The refined risk evaluation (step 2) will require realistic and representative data, higher tier modeling approaches, including probabilistic exposure modeling, and a more comprehensive consideration of human relevance and dose-response relationships. In a refined evaluation, EPA should also consider targeted exposure studies, as well as biomonitoring and environmental monitoring data, to the extent that this information is available and relevant. This approach is consistent with EPA's 2014 Framework for Human Health Risk Assessment to Inform Decision Making (HHRA Framework)4. which also emphasizes the importance of a fit-for-purpose approach to risk evaluation. This approach is also consistent with EPA's exposure assessment guidelines and practices. The concept of a tiered approach and a fit-for-purpose 5 evaluation are woven throughout ACC's recommendations. 4 See tps://www.epa.gov/sites/production/files/2014-12/documents/hhra-framework-final-2014.pdf. 5 See: tps://www.epa.gov/expobox/exposure-assessment-tools-tiers-and-types-screening-level-and-refined. 7 Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 The tiered approach ACC recommends is consistent with the approach EPA took in the problem formulation and initial assessment document for tetrabromobisphenol A (TBBPA.6 In that document, EPA conducted an initial screening level evaluation to support its conceptual model and analysis plan. EPA appropriately used high-end exposure values coupled with the lowest toxicity values to evaluate uses and exposure pathways of potential concern. While EPA did not share the relevant risk evaluation calculations in its public document, the general approach is consistent with that of a screening level risk evaluation. ACC encourages EPA to continue with this approach and to transparently and clearly present quantitative screening level analyses for the conditions of use and exposure scenarios that are part of the conceptual model EPA develops as part of the scoping phase. IV. The Rule Should Clarify the Process for Preparation and Contents of the Scope As noted above, Congress allowed a six month period for preparation of the scope of the risk evaluation, contemplating that time and effort would be needed to move from prioritization to a published scope. The six month period is to enable EPA to identify "the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations the Administrator expects to consider in the risk evaluation." Two things are evident from this language and the time frame afforded: 1) EPA should use this period to evaluate and decide which, if any, potentially exposed or susceptible subpopulations should be included in the risk evaluation (in other words, it need not include all such subpopulations, regardless of size, impact, or relevance); and 2) tEPA has flexibility to actually conduct a full risk evaluation of some or all the potential scenarios set out in the scope. In short, EPA need not include every conceivable condition of use in a risk evaluation. This view is further buttressed by the definition of "conditions of use" in Section 3 of the LCSA, which points to the need for EPA to determine the relevant conditions of use: "the circumstances, as determined by the Administrator, under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of." (Emphasis added). V. The Proposed Rule Should Include a Detailed Description of Substantive Elements of Risk Evaluation The term, "risk evaluation" is not expressly defined in the LCSA. While the term "risk assessment" has been widely used in EPA programs and operationally has clear meaning derived from years of guidance, policies and practices, that term was not used in the statute. Therefore even though it may be reasonable to assume "risk evaluation" may fully equate with the term "risk assessment," given the context of its use (integrating hazard with exposure) in the LCSA, EPA is encouraged to explicitly define and operationalize this term as part of its rulemaking. The term will not have clear meaning until an interpretation is assigned by EPA. We believe the essential elements of a Section 6 and 26 risk evaluation must be articulated in a clear regulatory definition as we discuss below. 6 EPA, Problem Formulation and Initial Assessment Tetrabromobisphenol A and Related Chemicals Cluster Flame Retardants, 2015, available at: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/tsca-work-plan-chemical-problem- formulation-and-2. 8 IPage Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 Section 6(b)(4)(B) of the statute requires EPA to establish, by rule, "a process to conduct risk evaluations." This process is itself required to meet a number of substantive elements described in the LCSA; a risk evaluation must: Be conducted in a manner designed to help the agency determine "whether a chemical substance presents an unreasonable risk of injury to health or the environment;" as set out in Section 6(b)(4)(A). Include consideration of "an unreasonable risk to a potentially exposed or susceptible subpopulation." EPA must identify relevant potentially exposed or susceptible subpopulations relevant to the risk evaluation under conditions of use; Address the specific elements set out in Section 6(b)(4)(F); and Comply with the specific requirements of Section 26, including the best available science, weight of the evidence, and transparency requirements. The very purpose of the risk evaluation is to develop the evidentiary and scientific basis to enable EPA to complete the risk determination required by statute. That risk determination has substantive impact - it significantly affects conduct, activity or a substantive interest that is the subject of agency regulation. The basis for the risk determination thus should be adequately described in the rule itself to offer sufficient notice to the regulated community. This is particularly important for decisions that inform safety and safety determinations. Likewise, decisions that have broad reaching impact should be supported in regulations, not merely through guidance or agency policy. 8 While EPA cannot substitute policy or guidance for a regulatory description of what will constitute a complete and robust risk evaluation, we believe the necessary elements can be developed in this rulemaking in a timely manner. VI. The Proposed Rule Should Ensure Consistency with Section 6(b)(4)(F) As discussed below, Section 6(b)(4)(F) of the LCSA describes five requirements for risk evaluations that shall be considered by the Administrator and must be incorporated into the risk evaluation rulemaking. 7 See, e.g., MST Express v. U.S. Department of Transportation, 108 F.3d 401 (D.C. Cir. 1997). DOT was directed under the Motor Carrier Safety Act (MCSA) to "prescribe regulations establishing a procedure to decide on the safety fitness of owners and operators of commercial motor vehicles." [Emphasis added]. The MCSA stated that implementing regulations would include "a means of deciding whether the owners, operators, and persons meet the safety fitness requirements." DOT promulgated regulations that set out a process for decision making but used guidance to articulate the tests by which the agency would determine whether vehicles met the safety fitness requirements. The court rejected DOT's reliance on guidance because it "failed to carry out its statutory obligation to establish by regulation a means of determining whether a carrier has complied with the safety fitness requirements." 8 As a general matter, "...it seems to be established that "regulations,' 'substantive rules' or 'legislative rules' are those which create law, usually implementary to an existing law." Gibson Wine Co. v. Snyder, 194 F.2d 329, 331 (D.C. Cir. 1952), cited by Brown Express, Inc. v. U.S., 607 F.2d 695, 700 (5th Cir. 1979). A "rule" is defined under Section 2 of the Administrative Procedure Act, in relevant part, as: "the whole or part of an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy or describing the organization, procedure, or practice requirements of an agency." 5 U.S.C. § 551(4). 9 I Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226

What does ACC represents?

ylcn0226

ylcn0226_p0, ylcn0226_p1, ylcn0226_p2, ylcn0226_p3, ylcn0226_p4, ylcn0226_p5, ylcn0226_p6, ylcn0226_p7, ylcn0226_p8, ylcn0226_p9

represents the leading companies engaged in the business of chemistry., leading companies engaged in the business of chemistry

Search 1/19/17 snapshot Assessing and Managing Chemicals under TSCA Contact Us Share Assessing and Managing Chemicals under The Frank R. Lautenberg TSCA Home Chemical Safety for the How EPA Assesses Chemical Safety 2 1st Century Act Assessments for TSCA Work Plan Chemicals On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for Sign up for Current Chemical the 21st Century Act which amends the Toxic TSCA and Risk Reduction Activities Other Substances Control Act (ISCA), the Nation's Chemical ChemView primary chemicals management law. Safety News Chemical Data Reporting The new law, which received bipartisan support in both the U.S. House of Representatives and Getemail alerts the Senate, includes much needed improvements such as: Enter email address sign up Mandatory requirement for EPA to evaluate existing chemicals with clear and enforceable deadlines; New risk-based safety standard; Increased public transparency for chemical information; and Recent Consistent source of funding for EPA to carry additions out the responsibilities under the new law. Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 American" Chemistry Council August 24, 2016 Wendy Cleland-Hamnett Director, Office of Pollution Prevention and Toxics Environmental Protection Agency 1200 Pennsylvania Ave. NW Washington, DC 20460-0001 Sent electronically to www.regulations.gov docket # EPA-HQ-OPPT-2016-0400 Re: ACC Comments to Inform EPA's Rulemaking on the Conduct of Risk Evaluations under the Lautenberg Chemical Safety Act Dear Ms. Cleland-Hamnett: The American Chemistry Council (ACC¹ appreciates the opportunity to provide input to the Office of Pollution Prevention and Toxics to inform the Agency's development of a risk evaluation rulemaking under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (LCSA). ACC has a long-standing commitment to a robust, science-based approach to evaluation of human and environmental risk. ACC is committed to the effective implementation of the LCSA and supports a workable, rigorous process that allows for timely, high quality reviews. Given the strong emphasis on a risk-based approach in the LCSA, the Section 6(b)(4) rulemaking is particularly important because it will guide the conduct of future risk evaluations that will then inform risk management activities. ACC is committed to being a constructive stakeholder throughout the implementation of LCSA. We will continue to draw from the breadth and depth of our member companies' expertise to ensure that our recommendations are not only science-based, but also allow for the efficient and effective implementation of the LCSA. In doing so, ACC will continue to consider the high quality science standards in the LCSA as well as the timeframes and deadlines imposed therein. The enclosed recommendations were developed with these important considerations in mind. If EPA has any questions, please contact me at nancy [email protected] or 202-249-6417. Sincerely, Nancy B. Beck, PhD, DABT Senior Director, Regulatory and Technical Affairs Cc: Jim Jones, OCSPP Assistant Administrator Louise Wise, Deputy Assistant Administrator Jeffery Morris, Deputy Director for Programs, OPPT Tala Henry, Director, Risk Assessment Division, OPPT 1 The American Chemistry Council (ACC) represents the leading companies engaged in the business of chemistry. More information about ACC is presented in the body of our comments. 1 IPage Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 American Chemistry Council Initial Input to U.S. Environmental Protection Agency In Regard to the Risk Evaluation Rule under the Lautenberg Chemical Safety Act Table of Contents I. Introduction and Executive Summary 4 II. The Risk Evaluation Rulemaking Must Include both Procedural And Substantive Elements to Effect the Purposes of the Statute 5 III. The Proposed Rule Should Include a Tiered Approach to Risk Evaluation 6 IV. The Rule Should Clarify the Process for Preparation and Contents of the Scope 8 V. The Proposed Rule Should Include a Detailed Description of Substantive Elements of Risk Evaluation 8 VI. Proposed Rule Should Ensure Consistency with Section 6(b)(4)(F) 9 a. Integration and Assessment of Information Relevant to Risks and Information on Potentially Exposed and Susceptible Populations 10 i. Conditions of Use That are Relevant 10 ii. Potentially Exposed or Susceptible Subpopulations 10 b. Aggregate and Sentinel Exposures 12 i. Aggregate Exposures 12 ii. Sentinel Exposures 12 c. Exposure Assessment 13 d. Weight of the Evidence 14 VII. The Proposed Rule Should Incorporate Section 26(h) Scientific Standards 14 a. Fit-for-Purpose Approach 15 b. Consideration of Relevant Information 16 i. Improving Hazard Assessment 16 ii. Improving Dose Response Assessment 17 iii. Reliance on Guidance 17 c. Importance of High Quality Risk Characterization 18 d. Clearly Addressing Variability and Uncertainty 18 e. Ensuring Appropriate Peer Review and Forming a Science Advisory Committee on Chemicals 19 21 Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 VIII. The Proposed Rule Should Implement a Weight of the Scientific Evidence (WoE) Approach 20 a. Systematic Review is Required 20 i. Development of a Protocol 21 ii. Search Strategy 21 iii. Transparency 21 b. A Systematic Review is Not Automatically a WoE Assessment 21 c. WoE and Systematic Review for Screening Level Risk Evaluations 22 d. WoE and Systematic Review for Refined Risk Evaluations 22 e. Strength of Evidence is Not the Same as WoE 23 IX. EPA Should Make Information Available Consistent with Section 26(j) 24 X. EPA Should Use Reasonably Available Information and CBI Consistent with Section 26(k) 24 XI. EPA Should Utilize Fit-for-Purpose Exposure Evaluation Tools 25 XII. The Requirements of Sections 6 and 26 Apply to Environmental Risk Evaluations 26 a. Advancing Models for Environmental Risks 27 b. Improving Data Sourcing, Generation, and Evaluation 27 c. Persistent, Bioaccumulative and Toxic (PBT) Substances 28 XIII. EPA Should Leverage International and Inter-Agency Cooperation 28 XIV. Incorporating High Throughput Tools and Alternative Methods 29 XV. Stakeholders and EPA Must Be Held to the Same High Standard 30 APPENDIX A: ACC's Principles for Improving Chemical Hazard and Risk Assessment 31 APPENDIX B: Improving Hazard Assessment 32 APPENDIX C: Improving Does Response Assessment 33 APPRNDIX D: Improving Risk Characterization 35 APPENDIX E: Ensuring Robust Peer Review 37 APPENDIX F: Exposure Modeling Tools 39 APPENDIX G: Additional Information on the ECETOC TRA 41 3 I P a 3 e Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 I. Introduction and Executive Summary The American Chemistry Council (ACC)2 is pleased to provide the U.S. Environmental Protection Agency (EPA) this initial input on the Lautenberg Chemical Safety Act's (LCSA) requirement for the Agency to establish, by rule, the process for conducting risk evaluations. ACC appreciates EPA's early efforts to obtain input from stakeholders at its August 9, 2016, public meeting. We also appreciate EPA's solicitation of written comments to be entered into the docket, well in advance of publication of the proposed rule. Our comments both clarify, as well as supplement and expand upon, the oral comments we presented at the August 9 meeting. ACC strongly supported Congress' efforts to update and reform the Toxic Substances Control Act (TSCA). We believe that high quality risk evaluation, using best available science and weight of the evidence (WoE), is at the very heart of the LCSA. Effective and efficient risk evaluations will help deliver the results intended by Congress. Section 6(b)(4)(B) of the statute requires EPA to establish, by rule, "a process to conduct risk evaluations.' This certainly should include a description of the sequence of events, timelines, opportunities for public comments and peer review. Both Sections 6 and 26 of the LCSA outline various substantive elements that apply to and inform risk evaluation. A risk evaluation must: Be conducted in a manner designed to determine "whether a chemical substance presents an unreasonable risk of injury to health or the environment;" as set out in Section 6(b)(4)(A); Identify whether there exists "an unreasonable risk to a potentially exposed or susceptible subpopulation." EPA must identify potentially exposed or susceptible subpopulations relevant to the risk evaluation under conditions of use; Address the specific elements set out in Section 6(b)(4)(F); and Comply with the specific requirements of Section 26, including the best available science, weight of the evidence, and transparency requirements. Because these elements are at the core of the risk evaluation process, and affect risk management measures, they are substantive and should be described in adequate detail in the regulation. In general, where risk evaluation elements are now required by statute, EPA should apply them uniformly and universally reflecting them in the body of the regulation. The recommendations provided by ACC in these comments address screening and refined risk evaluations and are meant to apply to both human health and environmental risks. Specific tools, testing methods, databases, and the like may develop over time, or course, and can be updated as necessary in policies, 2 The American Chemistry Council (ACC) represents the leading companies engaged in the business of chemistry. ACC members apply the science of chemistry to make innovative products and services that make people's lives better, healthier and safer. ACC is committed to improved environmental, health and safety performance through Responsible Care common sense advocacy designed to address major public policy issues, and health and environmental research and product testing. The business of chemistry is a $797 billion enterprise and a key element of the nation's economy. It is the nation's largest exporter, accounting for fourteen percent of all U.S. exports. Chemistry companies are among the largest investors in research and development. Safety and security have always been primary concerns of ACC members, and they have intensified their efforts, working closely with government agencies to improve security and to defend against any threat to the nation's critical infrastructure. 4 Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 procedures and guidance. Our comments strive to make these differentiations and explain where particular elements of risk evaluation should be included in the rule proper. Specifically, our recommendations suggest definitions, and procedural steps and elements that will allow EPA to ensure that risk evaluations are consistent with the statutory requirements for EPA to use the best available science and WoE approaches. The recommendations also include definitions and procedural steps are not expected to change over time. ACC has referenced each of our suggestions to an existing EPA guidance, a National Academies (NAS) report, or another authoritative body or peer reviewed report. For instance, the recommendations in EPA's 2000 Risk Characterization Handbook still represent best practices today. Adding adequate definitions and explanation to the rule is particularly important to achieving incorporation of statutory requirements. We also note that in addition to Section 6, Sections 26(h), 26(i), 26(j), and 26(k) of the LCSA each present legal requirements that are applicable to the risk evaluation. EPA will now need to provide a level of transparency regarding not only the inputs, but also the methods of the analysis, including clear descriptions of uncertainties and variability. EPA should leverage information from other jurisdictions where data and information is applicable and of sufficient quality to meet the science standards in the LCSA. Incorporating these elements into the rulemaking creates a better platform for clear and consistent articulation of the Agency's understanding of statutory requirements, and will better support consistent and uniform application of the elements of risk evaluation. It is critically important that EPA engage the public as EPA plans, scopes, and conducts risk evaluations. Industry scientists often have unique insight and experience with their companies' chemistries and collectively have a large body of knowledge of risk assessment processes globally, including an understanding of potential human health and environmental impacts. ACC encourages EPA to leverage this knowledge and engage early (well before draft risk evaluations are released) and frequently with industry throughout the risk evaluation process. II. The Risk Evaluation Rulemaking Must Include both Procedural and Substantive Elements to Effect the Purposes of the Statute Congress included a specific mandate to EPA to establish a risk evaluation rulemaking. There is little question that the rule must describe the process by which risk evaluations will be conducted. However, to 3 effect the purposes of the statute, the process described in the rule cannot merely set out timelines or the sequence of the risk evaluation. It must include a clear articulation of the substantive elements of risk evaluation, and more particularly, it must explain how it will apply the principles set out in Section 6(b)(4)(F), Section 26, and other parts of the statute. If Congress had intended the scientific standard of "best available science" or "weight of the scientific evidence" to be incorporated into guidance alone, it would have included them only in Section 26(1) on "policies, procedures and guidance." 3 "[T]he Administrator shall establish, by rule, a process to conduct risk evaluations in accordance with subparagraph (A) " Section 6(b)(4)(A). 5 I Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 The very purpose of the risk evaluation is to develop the evidentiary and scientific basis to enable EPA to complete the risk determination required by statute. That risk determination has substantive impact - it significantly affects conduct, activity or a substantive interest that is the subject of agency regulation. The determination following risk evaluation is a necessary prerequisite for a chemical to proceed to risk management, if warranted. The rule should thus include a clear description of how EPA will undertake risk evaluations in order to meet the new statutory requirements of the LCSA. This includes a description of the scoping process and requirements for a published scope as well as the elements of the risk evaluation itself and the mechanism for gauging adequacy as measured against statutory criteria. III. The Proposed Rule Should Include a Tiered Approach to Risk Evaluation We believe the statute contemplates a tiered approach to risk evaluation and recommend that EPA include a tiered approach in the rule. Under the LCSA, EPA must initiate the risk evaluation "upon designating" a chemical as a high-priority substance. The scope, however, is not required to be published "upon initiation" -- EPA has up to six months following the initiation of the risk evaluation to prepare and publish the scope. Congress intended this six month period to be used for a scoping exercise, where EPA identifies "the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations the Administrator expects to consider in the risk evaluation." This six month period is a "step" between the high priority designation and the publication of the scope. In order for EPA to conduct risk evaluations consistent with the quality required by the LCSA and within the timeframes required, EPA should conduct a screening level evaluation during the scoping phase. During the scoping phase of risk evaluations, tools exist to allow EPA to conduct quantitative screening level analyses of multiple exposure scenarios, as appropriate for consumers, sensitive subpopulations, and the environment. This will allow EPA to have a more tailored focus on those populations and exposures of greatest concern during a refined risk evaluation process. Figure 1 below depicts ACC's recommended approach. 6 I Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 - y 10 Worknlan High-Duality Refined Risk Evaluation High Pricrity Chemicats & DRAFT Chemicals Manufacturer Risk Evaluation Requested EXPOSSURES HAZARD Evaluation incorporating Sections 6 and 26 of the Lautenberg Chemicel Safety Act (LCSA): Scope/Screening Level Risk Evatuation Scientific Standards FINAL Susceprible Weight of Scientific Evidence Evaluations Risk Evaluation Exposures Pupulations or use Certain Conditions of Use Present Do not present an anreasonable risk an unreasonable risk Refined No further risk evaluation risk avaluation No further action; needed RUREMAKING PROCESS COMPLETE the Figure 1. A Two-Step Process for Conducting Risk Evaluations Note: This is a simplified version of the process. A tiered approach, where EPA uses the scoping step (step 1) to conduct a quantitative screening level analysis, will allow EPA to focus its limited resources on more robust refined risk evaluations for only those conditions of use where unreasonable risks cannot be ruled out. Screening-level assessments require less data and information, and are typically deterministic and based on conservative, health protective assumptions and methods. When a screening assessment indicates low risk for a particular condition of use, the Agency should have a high degree of confidence that the potential risks are much lower than the calculation and, therefore, the actual risks are lower and/or perhaps non-existent. However, when a screening-level risk assessment indicates a potential concern for an adverse effect, this does not mean that the actual risks are significant and warrant action. Rather, it indicates the Agency should take a second step in the risk evaluation process to refine the evaluation to more accurately quantify potential risks. The refined risk evaluation (step 2) will require realistic and representative data, higher tier modeling approaches, including probabilistic exposure modeling, and a more comprehensive consideration of human relevance and dose-response relationships. In a refined evaluation, EPA should also consider targeted exposure studies, as well as biomonitoring and environmental monitoring data, to the extent that this information is available and relevant. This approach is consistent with EPA's 2014 Framework for Human Health Risk Assessment to Inform Decision Making (HHRA Framework)4. which also emphasizes the importance of a fit-for-purpose approach to risk evaluation. This approach is also consistent with EPA's exposure assessment guidelines and practices. The concept of a tiered approach and a fit-for-purpose 5 evaluation are woven throughout ACC's recommendations. 4 See tps://www.epa.gov/sites/production/files/2014-12/documents/hhra-framework-final-2014.pdf. 5 See: tps://www.epa.gov/expobox/exposure-assessment-tools-tiers-and-types-screening-level-and-refined. 7 Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 The tiered approach ACC recommends is consistent with the approach EPA took in the problem formulation and initial assessment document for tetrabromobisphenol A (TBBPA.6 In that document, EPA conducted an initial screening level evaluation to support its conceptual model and analysis plan. EPA appropriately used high-end exposure values coupled with the lowest toxicity values to evaluate uses and exposure pathways of potential concern. While EPA did not share the relevant risk evaluation calculations in its public document, the general approach is consistent with that of a screening level risk evaluation. ACC encourages EPA to continue with this approach and to transparently and clearly present quantitative screening level analyses for the conditions of use and exposure scenarios that are part of the conceptual model EPA develops as part of the scoping phase. IV. The Rule Should Clarify the Process for Preparation and Contents of the Scope As noted above, Congress allowed a six month period for preparation of the scope of the risk evaluation, contemplating that time and effort would be needed to move from prioritization to a published scope. The six month period is to enable EPA to identify "the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations the Administrator expects to consider in the risk evaluation." Two things are evident from this language and the time frame afforded: 1) EPA should use this period to evaluate and decide which, if any, potentially exposed or susceptible subpopulations should be included in the risk evaluation (in other words, it need not include all such subpopulations, regardless of size, impact, or relevance); and 2) tEPA has flexibility to actually conduct a full risk evaluation of some or all the potential scenarios set out in the scope. In short, EPA need not include every conceivable condition of use in a risk evaluation. This view is further buttressed by the definition of "conditions of use" in Section 3 of the LCSA, which points to the need for EPA to determine the relevant conditions of use: "the circumstances, as determined by the Administrator, under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of." (Emphasis added). V. The Proposed Rule Should Include a Detailed Description of Substantive Elements of Risk Evaluation The term, "risk evaluation" is not expressly defined in the LCSA. While the term "risk assessment" has been widely used in EPA programs and operationally has clear meaning derived from years of guidance, policies and practices, that term was not used in the statute. Therefore even though it may be reasonable to assume "risk evaluation" may fully equate with the term "risk assessment," given the context of its use (integrating hazard with exposure) in the LCSA, EPA is encouraged to explicitly define and operationalize this term as part of its rulemaking. The term will not have clear meaning until an interpretation is assigned by EPA. We believe the essential elements of a Section 6 and 26 risk evaluation must be articulated in a clear regulatory definition as we discuss below. 6 EPA, Problem Formulation and Initial Assessment Tetrabromobisphenol A and Related Chemicals Cluster Flame Retardants, 2015, available at: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/tsca-work-plan-chemical-problem- formulation-and-2. 8 IPage Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 Section 6(b)(4)(B) of the statute requires EPA to establish, by rule, "a process to conduct risk evaluations." This process is itself required to meet a number of substantive elements described in the LCSA; a risk evaluation must: Be conducted in a manner designed to help the agency determine "whether a chemical substance presents an unreasonable risk of injury to health or the environment;" as set out in Section 6(b)(4)(A). Include consideration of "an unreasonable risk to a potentially exposed or susceptible subpopulation." EPA must identify relevant potentially exposed or susceptible subpopulations relevant to the risk evaluation under conditions of use; Address the specific elements set out in Section 6(b)(4)(F); and Comply with the specific requirements of Section 26, including the best available science, weight of the evidence, and transparency requirements. The very purpose of the risk evaluation is to develop the evidentiary and scientific basis to enable EPA to complete the risk determination required by statute. That risk determination has substantive impact - it significantly affects conduct, activity or a substantive interest that is the subject of agency regulation. The basis for the risk determination thus should be adequately described in the rule itself to offer sufficient notice to the regulated community. This is particularly important for decisions that inform safety and safety determinations. Likewise, decisions that have broad reaching impact should be supported in regulations, not merely through guidance or agency policy. 8 While EPA cannot substitute policy or guidance for a regulatory description of what will constitute a complete and robust risk evaluation, we believe the necessary elements can be developed in this rulemaking in a timely manner. VI. The Proposed Rule Should Ensure Consistency with Section 6(b)(4)(F) As discussed below, Section 6(b)(4)(F) of the LCSA describes five requirements for risk evaluations that shall be considered by the Administrator and must be incorporated into the risk evaluation rulemaking. 7 See, e.g., MST Express v. U.S. Department of Transportation, 108 F.3d 401 (D.C. Cir. 1997). DOT was directed under the Motor Carrier Safety Act (MCSA) to "prescribe regulations establishing a procedure to decide on the safety fitness of owners and operators of commercial motor vehicles." [Emphasis added]. The MCSA stated that implementing regulations would include "a means of deciding whether the owners, operators, and persons meet the safety fitness requirements." DOT promulgated regulations that set out a process for decision making but used guidance to articulate the tests by which the agency would determine whether vehicles met the safety fitness requirements. The court rejected DOT's reliance on guidance because it "failed to carry out its statutory obligation to establish by regulation a means of determining whether a carrier has complied with the safety fitness requirements." 8 As a general matter, "...it seems to be established that "regulations,' 'substantive rules' or 'legislative rules' are those which create law, usually implementary to an existing law." Gibson Wine Co. v. Snyder, 194 F.2d 329, 331 (D.C. Cir. 1952), cited by Brown Express, Inc. v. U.S., 607 F.2d 695, 700 (5th Cir. 1979). A "rule" is defined under Section 2 of the Administrative Procedure Act, in relevant part, as: "the whole or part of an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy or describing the organization, procedure, or practice requirements of an agency." 5 U.S.C. § 551(4). 9 I Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226

Who is the director of office of Pollution Prevention and Toxics?

ylcn0226

ylcn0226_p0, ylcn0226_p1, ylcn0226_p2, ylcn0226_p3, ylcn0226_p4, ylcn0226_p5, ylcn0226_p6, ylcn0226_p7, ylcn0226_p8, ylcn0226_p9

Wendy Cleland-Hamnett

Search 1/19/17 snapshot Assessing and Managing Chemicals under TSCA Contact Us Share Assessing and Managing Chemicals under The Frank R. Lautenberg TSCA Home Chemical Safety for the How EPA Assesses Chemical Safety 2 1st Century Act Assessments for TSCA Work Plan Chemicals On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for Sign up for Current Chemical the 21st Century Act which amends the Toxic TSCA and Risk Reduction Activities Other Substances Control Act (ISCA), the Nation's Chemical ChemView primary chemicals management law. Safety News Chemical Data Reporting The new law, which received bipartisan support in both the U.S. House of Representatives and Getemail alerts the Senate, includes much needed improvements such as: Enter email address sign up Mandatory requirement for EPA to evaluate existing chemicals with clear and enforceable deadlines; New risk-based safety standard; Increased public transparency for chemical information; and Recent Consistent source of funding for EPA to carry additions out the responsibilities under the new law. Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 American" Chemistry Council August 24, 2016 Wendy Cleland-Hamnett Director, Office of Pollution Prevention and Toxics Environmental Protection Agency 1200 Pennsylvania Ave. NW Washington, DC 20460-0001 Sent electronically to www.regulations.gov docket # EPA-HQ-OPPT-2016-0400 Re: ACC Comments to Inform EPA's Rulemaking on the Conduct of Risk Evaluations under the Lautenberg Chemical Safety Act Dear Ms. Cleland-Hamnett: The American Chemistry Council (ACC¹ appreciates the opportunity to provide input to the Office of Pollution Prevention and Toxics to inform the Agency's development of a risk evaluation rulemaking under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (LCSA). ACC has a long-standing commitment to a robust, science-based approach to evaluation of human and environmental risk. ACC is committed to the effective implementation of the LCSA and supports a workable, rigorous process that allows for timely, high quality reviews. Given the strong emphasis on a risk-based approach in the LCSA, the Section 6(b)(4) rulemaking is particularly important because it will guide the conduct of future risk evaluations that will then inform risk management activities. ACC is committed to being a constructive stakeholder throughout the implementation of LCSA. We will continue to draw from the breadth and depth of our member companies' expertise to ensure that our recommendations are not only science-based, but also allow for the efficient and effective implementation of the LCSA. In doing so, ACC will continue to consider the high quality science standards in the LCSA as well as the timeframes and deadlines imposed therein. The enclosed recommendations were developed with these important considerations in mind. If EPA has any questions, please contact me at nancy [email protected] or 202-249-6417. Sincerely, Nancy B. Beck, PhD, DABT Senior Director, Regulatory and Technical Affairs Cc: Jim Jones, OCSPP Assistant Administrator Louise Wise, Deputy Assistant Administrator Jeffery Morris, Deputy Director for Programs, OPPT Tala Henry, Director, Risk Assessment Division, OPPT 1 The American Chemistry Council (ACC) represents the leading companies engaged in the business of chemistry. More information about ACC is presented in the body of our comments. 1 IPage Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 American Chemistry Council Initial Input to U.S. Environmental Protection Agency In Regard to the Risk Evaluation Rule under the Lautenberg Chemical Safety Act Table of Contents I. Introduction and Executive Summary 4 II. The Risk Evaluation Rulemaking Must Include both Procedural And Substantive Elements to Effect the Purposes of the Statute 5 III. The Proposed Rule Should Include a Tiered Approach to Risk Evaluation 6 IV. The Rule Should Clarify the Process for Preparation and Contents of the Scope 8 V. The Proposed Rule Should Include a Detailed Description of Substantive Elements of Risk Evaluation 8 VI. Proposed Rule Should Ensure Consistency with Section 6(b)(4)(F) 9 a. Integration and Assessment of Information Relevant to Risks and Information on Potentially Exposed and Susceptible Populations 10 i. Conditions of Use That are Relevant 10 ii. Potentially Exposed or Susceptible Subpopulations 10 b. Aggregate and Sentinel Exposures 12 i. Aggregate Exposures 12 ii. Sentinel Exposures 12 c. Exposure Assessment 13 d. Weight of the Evidence 14 VII. The Proposed Rule Should Incorporate Section 26(h) Scientific Standards 14 a. Fit-for-Purpose Approach 15 b. Consideration of Relevant Information 16 i. Improving Hazard Assessment 16 ii. Improving Dose Response Assessment 17 iii. Reliance on Guidance 17 c. Importance of High Quality Risk Characterization 18 d. Clearly Addressing Variability and Uncertainty 18 e. Ensuring Appropriate Peer Review and Forming a Science Advisory Committee on Chemicals 19 21 Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 VIII. The Proposed Rule Should Implement a Weight of the Scientific Evidence (WoE) Approach 20 a. Systematic Review is Required 20 i. Development of a Protocol 21 ii. Search Strategy 21 iii. Transparency 21 b. A Systematic Review is Not Automatically a WoE Assessment 21 c. WoE and Systematic Review for Screening Level Risk Evaluations 22 d. WoE and Systematic Review for Refined Risk Evaluations 22 e. Strength of Evidence is Not the Same as WoE 23 IX. EPA Should Make Information Available Consistent with Section 26(j) 24 X. EPA Should Use Reasonably Available Information and CBI Consistent with Section 26(k) 24 XI. EPA Should Utilize Fit-for-Purpose Exposure Evaluation Tools 25 XII. The Requirements of Sections 6 and 26 Apply to Environmental Risk Evaluations 26 a. Advancing Models for Environmental Risks 27 b. Improving Data Sourcing, Generation, and Evaluation 27 c. Persistent, Bioaccumulative and Toxic (PBT) Substances 28 XIII. EPA Should Leverage International and Inter-Agency Cooperation 28 XIV. Incorporating High Throughput Tools and Alternative Methods 29 XV. Stakeholders and EPA Must Be Held to the Same High Standard 30 APPENDIX A: ACC's Principles for Improving Chemical Hazard and Risk Assessment 31 APPENDIX B: Improving Hazard Assessment 32 APPENDIX C: Improving Does Response Assessment 33 APPRNDIX D: Improving Risk Characterization 35 APPENDIX E: Ensuring Robust Peer Review 37 APPENDIX F: Exposure Modeling Tools 39 APPENDIX G: Additional Information on the ECETOC TRA 41 3 I P a 3 e Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 I. Introduction and Executive Summary The American Chemistry Council (ACC)2 is pleased to provide the U.S. Environmental Protection Agency (EPA) this initial input on the Lautenberg Chemical Safety Act's (LCSA) requirement for the Agency to establish, by rule, the process for conducting risk evaluations. ACC appreciates EPA's early efforts to obtain input from stakeholders at its August 9, 2016, public meeting. We also appreciate EPA's solicitation of written comments to be entered into the docket, well in advance of publication of the proposed rule. Our comments both clarify, as well as supplement and expand upon, the oral comments we presented at the August 9 meeting. ACC strongly supported Congress' efforts to update and reform the Toxic Substances Control Act (TSCA). We believe that high quality risk evaluation, using best available science and weight of the evidence (WoE), is at the very heart of the LCSA. Effective and efficient risk evaluations will help deliver the results intended by Congress. Section 6(b)(4)(B) of the statute requires EPA to establish, by rule, "a process to conduct risk evaluations.' This certainly should include a description of the sequence of events, timelines, opportunities for public comments and peer review. Both Sections 6 and 26 of the LCSA outline various substantive elements that apply to and inform risk evaluation. A risk evaluation must: Be conducted in a manner designed to determine "whether a chemical substance presents an unreasonable risk of injury to health or the environment;" as set out in Section 6(b)(4)(A); Identify whether there exists "an unreasonable risk to a potentially exposed or susceptible subpopulation." EPA must identify potentially exposed or susceptible subpopulations relevant to the risk evaluation under conditions of use; Address the specific elements set out in Section 6(b)(4)(F); and Comply with the specific requirements of Section 26, including the best available science, weight of the evidence, and transparency requirements. Because these elements are at the core of the risk evaluation process, and affect risk management measures, they are substantive and should be described in adequate detail in the regulation. In general, where risk evaluation elements are now required by statute, EPA should apply them uniformly and universally reflecting them in the body of the regulation. The recommendations provided by ACC in these comments address screening and refined risk evaluations and are meant to apply to both human health and environmental risks. Specific tools, testing methods, databases, and the like may develop over time, or course, and can be updated as necessary in policies, 2 The American Chemistry Council (ACC) represents the leading companies engaged in the business of chemistry. ACC members apply the science of chemistry to make innovative products and services that make people's lives better, healthier and safer. ACC is committed to improved environmental, health and safety performance through Responsible Care common sense advocacy designed to address major public policy issues, and health and environmental research and product testing. The business of chemistry is a $797 billion enterprise and a key element of the nation's economy. It is the nation's largest exporter, accounting for fourteen percent of all U.S. exports. Chemistry companies are among the largest investors in research and development. Safety and security have always been primary concerns of ACC members, and they have intensified their efforts, working closely with government agencies to improve security and to defend against any threat to the nation's critical infrastructure. 4 Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 procedures and guidance. Our comments strive to make these differentiations and explain where particular elements of risk evaluation should be included in the rule proper. Specifically, our recommendations suggest definitions, and procedural steps and elements that will allow EPA to ensure that risk evaluations are consistent with the statutory requirements for EPA to use the best available science and WoE approaches. The recommendations also include definitions and procedural steps are not expected to change over time. ACC has referenced each of our suggestions to an existing EPA guidance, a National Academies (NAS) report, or another authoritative body or peer reviewed report. For instance, the recommendations in EPA's 2000 Risk Characterization Handbook still represent best practices today. Adding adequate definitions and explanation to the rule is particularly important to achieving incorporation of statutory requirements. We also note that in addition to Section 6, Sections 26(h), 26(i), 26(j), and 26(k) of the LCSA each present legal requirements that are applicable to the risk evaluation. EPA will now need to provide a level of transparency regarding not only the inputs, but also the methods of the analysis, including clear descriptions of uncertainties and variability. EPA should leverage information from other jurisdictions where data and information is applicable and of sufficient quality to meet the science standards in the LCSA. Incorporating these elements into the rulemaking creates a better platform for clear and consistent articulation of the Agency's understanding of statutory requirements, and will better support consistent and uniform application of the elements of risk evaluation. It is critically important that EPA engage the public as EPA plans, scopes, and conducts risk evaluations. Industry scientists often have unique insight and experience with their companies' chemistries and collectively have a large body of knowledge of risk assessment processes globally, including an understanding of potential human health and environmental impacts. ACC encourages EPA to leverage this knowledge and engage early (well before draft risk evaluations are released) and frequently with industry throughout the risk evaluation process. II. The Risk Evaluation Rulemaking Must Include both Procedural and Substantive Elements to Effect the Purposes of the Statute Congress included a specific mandate to EPA to establish a risk evaluation rulemaking. There is little question that the rule must describe the process by which risk evaluations will be conducted. However, to 3 effect the purposes of the statute, the process described in the rule cannot merely set out timelines or the sequence of the risk evaluation. It must include a clear articulation of the substantive elements of risk evaluation, and more particularly, it must explain how it will apply the principles set out in Section 6(b)(4)(F), Section 26, and other parts of the statute. If Congress had intended the scientific standard of "best available science" or "weight of the scientific evidence" to be incorporated into guidance alone, it would have included them only in Section 26(1) on "policies, procedures and guidance." 3 "[T]he Administrator shall establish, by rule, a process to conduct risk evaluations in accordance with subparagraph (A) " Section 6(b)(4)(A). 5 I Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 The very purpose of the risk evaluation is to develop the evidentiary and scientific basis to enable EPA to complete the risk determination required by statute. That risk determination has substantive impact - it significantly affects conduct, activity or a substantive interest that is the subject of agency regulation. The determination following risk evaluation is a necessary prerequisite for a chemical to proceed to risk management, if warranted. The rule should thus include a clear description of how EPA will undertake risk evaluations in order to meet the new statutory requirements of the LCSA. This includes a description of the scoping process and requirements for a published scope as well as the elements of the risk evaluation itself and the mechanism for gauging adequacy as measured against statutory criteria. III. The Proposed Rule Should Include a Tiered Approach to Risk Evaluation We believe the statute contemplates a tiered approach to risk evaluation and recommend that EPA include a tiered approach in the rule. Under the LCSA, EPA must initiate the risk evaluation "upon designating" a chemical as a high-priority substance. The scope, however, is not required to be published "upon initiation" -- EPA has up to six months following the initiation of the risk evaluation to prepare and publish the scope. Congress intended this six month period to be used for a scoping exercise, where EPA identifies "the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations the Administrator expects to consider in the risk evaluation." This six month period is a "step" between the high priority designation and the publication of the scope. In order for EPA to conduct risk evaluations consistent with the quality required by the LCSA and within the timeframes required, EPA should conduct a screening level evaluation during the scoping phase. During the scoping phase of risk evaluations, tools exist to allow EPA to conduct quantitative screening level analyses of multiple exposure scenarios, as appropriate for consumers, sensitive subpopulations, and the environment. This will allow EPA to have a more tailored focus on those populations and exposures of greatest concern during a refined risk evaluation process. Figure 1 below depicts ACC's recommended approach. 6 I Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 - y 10 Worknlan High-Duality Refined Risk Evaluation High Pricrity Chemicats & DRAFT Chemicals Manufacturer Risk Evaluation Requested EXPOSSURES HAZARD Evaluation incorporating Sections 6 and 26 of the Lautenberg Chemicel Safety Act (LCSA): Scope/Screening Level Risk Evatuation Scientific Standards FINAL Susceprible Weight of Scientific Evidence Evaluations Risk Evaluation Exposures Pupulations or use Certain Conditions of Use Present Do not present an anreasonable risk an unreasonable risk Refined No further risk evaluation risk avaluation No further action; needed RUREMAKING PROCESS COMPLETE the Figure 1. A Two-Step Process for Conducting Risk Evaluations Note: This is a simplified version of the process. A tiered approach, where EPA uses the scoping step (step 1) to conduct a quantitative screening level analysis, will allow EPA to focus its limited resources on more robust refined risk evaluations for only those conditions of use where unreasonable risks cannot be ruled out. Screening-level assessments require less data and information, and are typically deterministic and based on conservative, health protective assumptions and methods. When a screening assessment indicates low risk for a particular condition of use, the Agency should have a high degree of confidence that the potential risks are much lower than the calculation and, therefore, the actual risks are lower and/or perhaps non-existent. However, when a screening-level risk assessment indicates a potential concern for an adverse effect, this does not mean that the actual risks are significant and warrant action. Rather, it indicates the Agency should take a second step in the risk evaluation process to refine the evaluation to more accurately quantify potential risks. The refined risk evaluation (step 2) will require realistic and representative data, higher tier modeling approaches, including probabilistic exposure modeling, and a more comprehensive consideration of human relevance and dose-response relationships. In a refined evaluation, EPA should also consider targeted exposure studies, as well as biomonitoring and environmental monitoring data, to the extent that this information is available and relevant. This approach is consistent with EPA's 2014 Framework for Human Health Risk Assessment to Inform Decision Making (HHRA Framework)4. which also emphasizes the importance of a fit-for-purpose approach to risk evaluation. This approach is also consistent with EPA's exposure assessment guidelines and practices. The concept of a tiered approach and a fit-for-purpose 5 evaluation are woven throughout ACC's recommendations. 4 See tps://www.epa.gov/sites/production/files/2014-12/documents/hhra-framework-final-2014.pdf. 5 See: tps://www.epa.gov/expobox/exposure-assessment-tools-tiers-and-types-screening-level-and-refined. 7 Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 The tiered approach ACC recommends is consistent with the approach EPA took in the problem formulation and initial assessment document for tetrabromobisphenol A (TBBPA.6 In that document, EPA conducted an initial screening level evaluation to support its conceptual model and analysis plan. EPA appropriately used high-end exposure values coupled with the lowest toxicity values to evaluate uses and exposure pathways of potential concern. While EPA did not share the relevant risk evaluation calculations in its public document, the general approach is consistent with that of a screening level risk evaluation. ACC encourages EPA to continue with this approach and to transparently and clearly present quantitative screening level analyses for the conditions of use and exposure scenarios that are part of the conceptual model EPA develops as part of the scoping phase. IV. The Rule Should Clarify the Process for Preparation and Contents of the Scope As noted above, Congress allowed a six month period for preparation of the scope of the risk evaluation, contemplating that time and effort would be needed to move from prioritization to a published scope. The six month period is to enable EPA to identify "the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations the Administrator expects to consider in the risk evaluation." Two things are evident from this language and the time frame afforded: 1) EPA should use this period to evaluate and decide which, if any, potentially exposed or susceptible subpopulations should be included in the risk evaluation (in other words, it need not include all such subpopulations, regardless of size, impact, or relevance); and 2) tEPA has flexibility to actually conduct a full risk evaluation of some or all the potential scenarios set out in the scope. In short, EPA need not include every conceivable condition of use in a risk evaluation. This view is further buttressed by the definition of "conditions of use" in Section 3 of the LCSA, which points to the need for EPA to determine the relevant conditions of use: "the circumstances, as determined by the Administrator, under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of." (Emphasis added). V. The Proposed Rule Should Include a Detailed Description of Substantive Elements of Risk Evaluation The term, "risk evaluation" is not expressly defined in the LCSA. While the term "risk assessment" has been widely used in EPA programs and operationally has clear meaning derived from years of guidance, policies and practices, that term was not used in the statute. Therefore even though it may be reasonable to assume "risk evaluation" may fully equate with the term "risk assessment," given the context of its use (integrating hazard with exposure) in the LCSA, EPA is encouraged to explicitly define and operationalize this term as part of its rulemaking. The term will not have clear meaning until an interpretation is assigned by EPA. We believe the essential elements of a Section 6 and 26 risk evaluation must be articulated in a clear regulatory definition as we discuss below. 6 EPA, Problem Formulation and Initial Assessment Tetrabromobisphenol A and Related Chemicals Cluster Flame Retardants, 2015, available at: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/tsca-work-plan-chemical-problem- formulation-and-2. 8 IPage Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 Section 6(b)(4)(B) of the statute requires EPA to establish, by rule, "a process to conduct risk evaluations." This process is itself required to meet a number of substantive elements described in the LCSA; a risk evaluation must: Be conducted in a manner designed to help the agency determine "whether a chemical substance presents an unreasonable risk of injury to health or the environment;" as set out in Section 6(b)(4)(A). Include consideration of "an unreasonable risk to a potentially exposed or susceptible subpopulation." EPA must identify relevant potentially exposed or susceptible subpopulations relevant to the risk evaluation under conditions of use; Address the specific elements set out in Section 6(b)(4)(F); and Comply with the specific requirements of Section 26, including the best available science, weight of the evidence, and transparency requirements. The very purpose of the risk evaluation is to develop the evidentiary and scientific basis to enable EPA to complete the risk determination required by statute. That risk determination has substantive impact - it significantly affects conduct, activity or a substantive interest that is the subject of agency regulation. The basis for the risk determination thus should be adequately described in the rule itself to offer sufficient notice to the regulated community. This is particularly important for decisions that inform safety and safety determinations. Likewise, decisions that have broad reaching impact should be supported in regulations, not merely through guidance or agency policy. 8 While EPA cannot substitute policy or guidance for a regulatory description of what will constitute a complete and robust risk evaluation, we believe the necessary elements can be developed in this rulemaking in a timely manner. VI. The Proposed Rule Should Ensure Consistency with Section 6(b)(4)(F) As discussed below, Section 6(b)(4)(F) of the LCSA describes five requirements for risk evaluations that shall be considered by the Administrator and must be incorporated into the risk evaluation rulemaking. 7 See, e.g., MST Express v. U.S. Department of Transportation, 108 F.3d 401 (D.C. Cir. 1997). DOT was directed under the Motor Carrier Safety Act (MCSA) to "prescribe regulations establishing a procedure to decide on the safety fitness of owners and operators of commercial motor vehicles." [Emphasis added]. The MCSA stated that implementing regulations would include "a means of deciding whether the owners, operators, and persons meet the safety fitness requirements." DOT promulgated regulations that set out a process for decision making but used guidance to articulate the tests by which the agency would determine whether vehicles met the safety fitness requirements. The court rejected DOT's reliance on guidance because it "failed to carry out its statutory obligation to establish by regulation a means of determining whether a carrier has complied with the safety fitness requirements." 8 As a general matter, "...it seems to be established that "regulations,' 'substantive rules' or 'legislative rules' are those which create law, usually implementary to an existing law." Gibson Wine Co. v. Snyder, 194 F.2d 329, 331 (D.C. Cir. 1952), cited by Brown Express, Inc. v. U.S., 607 F.2d 695, 700 (5th Cir. 1979). A "rule" is defined under Section 2 of the Administrative Procedure Act, in relevant part, as: "the whole or part of an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy or describing the organization, procedure, or practice requirements of an agency." 5 U.S.C. § 551(4). 9 I Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226

mention the first point of critical elements under prioritization to be successful

jzbn0226

jzbn0226_p24, jzbn0226_p25, jzbn0226_p26

reliable and up-to-date chemical data and information

C. Waivers EPA has proposed that all comments that could be raised on issues in a proposed low priority designation be presented during the comment period, and that any issues not raised then be considered to have been waived. Waived issues could not form the basis of an objection or challenge in any subsequent administrative or judicial proceeding on the designation of the substance as a low priority substance (which is subject to judicial review). EPA points to the statutory deadlines in the prioritization process as the policy justification for this proposal. 38 ACC urges EPA to remove this waiver requirement from the prioritization rule. First, it is inconsistent with Congress's intent that the prioritization process be iterative and science-based. Low priority designations should be able to be modified - expanded or contracted - based on new information that is brought to the Agency's attention after the designation. This new information might not have been known during the public comment period on the low priority designation. It would be bad public policy to consider new information waived because that could discourage stakeholders from gathering or developing relevant information about a chemical. Second, participation in the notice and comment rulemaking process of prioritization is governed by statute - through the Administrative Procedures Act (APA) and the judicial review provisions of Section 19 of TSCA. There are no issue exhaustion provisions in TSCA. EPA cannot by regulation, impose an issue exhaustion requirement that trumps the statutory rights and obligations of stakeholders under the APA and TSCA Section 19.39 D. Definitions As an addendum to ACC's recommendations for EPA to reference the Section 26 science standards in the prioritization process rule, ACC offers the following definitions for EPA's consideration: Best available science means information that has been evaluated based on its strengths, limitations and relevance and the Agency is relying on the highest quality information. In evaluating best available science the Agency will also consider the peer review of the science, whether the study was conducted in accordance with sound and objective practices, and if the data were collected by accepted methods or best available methods. To ensure transparency regarding best available science the Agency will describe and document any assumptions and methods used, and address variability, uncertainty, the degree of independent verification and peer review. Weight of the evidence means a systematic review method that uses a pre-established protocol to comprehensively, objectively, transparently, and consistently, identify and evaluate each stream of evidence, including strengths, limitations, and relevance of each study and to integrate evidence as necessary and appropriate based upon strengths, limitations, and relevance. 38 Id. at 4833. 39 See ACC Comments on EPA's Proposed Rule: Procedures for Chemical Risk Evaluation under the Amended Toxic Substances Control Act (RIN 2070- AK20) for additional discussion of the waiver/lock down/issue exhaustion issue. 23 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 E. Repopulation of High Priority Substances EPA's preamble discussion of the "repopulation" of high priority substances40 presents a reasonable approach by which the Agency could meet the LCSA obligation to finalize the designation of one new high priority substance upon completion of a risk evaluation for another substance. The one-for-one approach makes sense as this program gets underway. ACC suggests, however, that EPA consider a placeholder in its rule to anticipate changes in the rate at which EPA might be able to conduct risk evaluations over time (based on use of 21st Century tools and methods) and hence potentially change the rate at which EPA may need to designate high priorities for risk evaluation. VIII. Summary of ACC's Recommendations: Throughout these comments, ACC has included many specific recommendations for EPA to consider as it develops its final prioritization process rule to address ACC's concerns about the proposed rule. These recommendations urge EPA to direct its authority on what it is mandated to do under the LCSA - designate high priority and low priority chemicals for risk evaluations in accordance with both the criteria in LCSA Section 6 and the LCSA Section 26 science based standards. To help the regulated community provide EPA the information the Agency will need to prioritize chemicals for risk evaluations, EPA must clarify the prioritization process as a whole and develop an efficient and focused prioritization process rule that meets the LCSA mandate and Congressional intent. ACC strongly urges EPA to amend its proposal to include these suggested recommendations and seek public comment before finalizing the prioritization process rule. Alternatively, EPA should propose a supplemental rule providing more detail and clarifications on the prioritization process steps involved and finalize it prior to the Agency's first application of the prioritization process . To help foster the submission of information needed to prioritize chemicals for risk evaluations, EPA must ultimately develop an efficient and focused prioritization process rule that clearly lays out the major steps for meeting its mandate. 40 82 Fed. Reg. at 4833. 24 Source: :ttps://www.industrydocuments.ucsf.edu/docs/jzbn0226 Attachment A ACC's General Principles on Prioritization (Developed for EPA Dialogue 7-2011) EPA should systematically prioritize chemicals for purposes of safe use determinations. As a general matter, prioritization should be based on existing hazard and exposure data and information (including models, read across, QSAR, etc.) and industry should be responsible for providing EPA with this data and information. Chemicals lacking adequate hazard and exposure information should be considered a higher priority (until relevant information is provided that suggests otherwise). Industry should be provided an opportunity to provide EPA additional data/information. (Timing is an issue, however. And the format in which the information is provided to EPA must be useable/digestible by EPA, e.g. robust summaries.) Hazard, use and exposure based criteria should be integrated to form the basis for EPA's prioritization decisions. Prioritization should not be based on either hazard-only or exposure-only information. The prioritization process and science based criteria that EPA uses to prioritize chemicals must be transparent. Prioritization should be a dynamic, iterative process. Re-examination of priorities should occur as new information becomes available and as new chemicals are approved for manufacturing. For prioritization to be successful, it must include three critical elements: reliable and up- to- date chemical data and information; evaluation criteria that consider both hazard and exposure information together; and established cutoffs to make priority decisions. EPA's communication about priority chemicals must be clear about what the list is and what it is not, to avoid unintended consequences of product de-selection purely on the basis of listing. Transparency; consistent, scientific criteria; intersection of both hazard and exposure information; dynamic process so new information can be incorporated as it is made available and so if priorities are initially "wrong" they can be corrected. 25 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226

Who is the sender of this letter?

ylcn0226

ylcn0226_p0, ylcn0226_p1, ylcn0226_p2, ylcn0226_p3, ylcn0226_p4, ylcn0226_p5, ylcn0226_p6, ylcn0226_p7, ylcn0226_p8, ylcn0226_p9

Nancy B. Beck, PhD, DABT, Nancy B. Beck

Search 1/19/17 snapshot Assessing and Managing Chemicals under TSCA Contact Us Share Assessing and Managing Chemicals under The Frank R. Lautenberg TSCA Home Chemical Safety for the How EPA Assesses Chemical Safety 2 1st Century Act Assessments for TSCA Work Plan Chemicals On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for Sign up for Current Chemical the 21st Century Act which amends the Toxic TSCA and Risk Reduction Activities Other Substances Control Act (ISCA), the Nation's Chemical ChemView primary chemicals management law. Safety News Chemical Data Reporting The new law, which received bipartisan support in both the U.S. House of Representatives and Getemail alerts the Senate, includes much needed improvements such as: Enter email address sign up Mandatory requirement for EPA to evaluate existing chemicals with clear and enforceable deadlines; New risk-based safety standard; Increased public transparency for chemical information; and Recent Consistent source of funding for EPA to carry additions out the responsibilities under the new law. Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 American" Chemistry Council August 24, 2016 Wendy Cleland-Hamnett Director, Office of Pollution Prevention and Toxics Environmental Protection Agency 1200 Pennsylvania Ave. NW Washington, DC 20460-0001 Sent electronically to www.regulations.gov docket # EPA-HQ-OPPT-2016-0400 Re: ACC Comments to Inform EPA's Rulemaking on the Conduct of Risk Evaluations under the Lautenberg Chemical Safety Act Dear Ms. Cleland-Hamnett: The American Chemistry Council (ACC¹ appreciates the opportunity to provide input to the Office of Pollution Prevention and Toxics to inform the Agency's development of a risk evaluation rulemaking under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (LCSA). ACC has a long-standing commitment to a robust, science-based approach to evaluation of human and environmental risk. ACC is committed to the effective implementation of the LCSA and supports a workable, rigorous process that allows for timely, high quality reviews. Given the strong emphasis on a risk-based approach in the LCSA, the Section 6(b)(4) rulemaking is particularly important because it will guide the conduct of future risk evaluations that will then inform risk management activities. ACC is committed to being a constructive stakeholder throughout the implementation of LCSA. We will continue to draw from the breadth and depth of our member companies' expertise to ensure that our recommendations are not only science-based, but also allow for the efficient and effective implementation of the LCSA. In doing so, ACC will continue to consider the high quality science standards in the LCSA as well as the timeframes and deadlines imposed therein. The enclosed recommendations were developed with these important considerations in mind. If EPA has any questions, please contact me at nancy [email protected] or 202-249-6417. Sincerely, Nancy B. Beck, PhD, DABT Senior Director, Regulatory and Technical Affairs Cc: Jim Jones, OCSPP Assistant Administrator Louise Wise, Deputy Assistant Administrator Jeffery Morris, Deputy Director for Programs, OPPT Tala Henry, Director, Risk Assessment Division, OPPT 1 The American Chemistry Council (ACC) represents the leading companies engaged in the business of chemistry. More information about ACC is presented in the body of our comments. 1 IPage Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 American Chemistry Council Initial Input to U.S. Environmental Protection Agency In Regard to the Risk Evaluation Rule under the Lautenberg Chemical Safety Act Table of Contents I. Introduction and Executive Summary 4 II. The Risk Evaluation Rulemaking Must Include both Procedural And Substantive Elements to Effect the Purposes of the Statute 5 III. The Proposed Rule Should Include a Tiered Approach to Risk Evaluation 6 IV. The Rule Should Clarify the Process for Preparation and Contents of the Scope 8 V. The Proposed Rule Should Include a Detailed Description of Substantive Elements of Risk Evaluation 8 VI. Proposed Rule Should Ensure Consistency with Section 6(b)(4)(F) 9 a. Integration and Assessment of Information Relevant to Risks and Information on Potentially Exposed and Susceptible Populations 10 i. Conditions of Use That are Relevant 10 ii. Potentially Exposed or Susceptible Subpopulations 10 b. Aggregate and Sentinel Exposures 12 i. Aggregate Exposures 12 ii. Sentinel Exposures 12 c. Exposure Assessment 13 d. Weight of the Evidence 14 VII. The Proposed Rule Should Incorporate Section 26(h) Scientific Standards 14 a. Fit-for-Purpose Approach 15 b. Consideration of Relevant Information 16 i. Improving Hazard Assessment 16 ii. Improving Dose Response Assessment 17 iii. Reliance on Guidance 17 c. Importance of High Quality Risk Characterization 18 d. Clearly Addressing Variability and Uncertainty 18 e. Ensuring Appropriate Peer Review and Forming a Science Advisory Committee on Chemicals 19 21 Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 VIII. The Proposed Rule Should Implement a Weight of the Scientific Evidence (WoE) Approach 20 a. Systematic Review is Required 20 i. Development of a Protocol 21 ii. Search Strategy 21 iii. Transparency 21 b. A Systematic Review is Not Automatically a WoE Assessment 21 c. WoE and Systematic Review for Screening Level Risk Evaluations 22 d. WoE and Systematic Review for Refined Risk Evaluations 22 e. Strength of Evidence is Not the Same as WoE 23 IX. EPA Should Make Information Available Consistent with Section 26(j) 24 X. EPA Should Use Reasonably Available Information and CBI Consistent with Section 26(k) 24 XI. EPA Should Utilize Fit-for-Purpose Exposure Evaluation Tools 25 XII. The Requirements of Sections 6 and 26 Apply to Environmental Risk Evaluations 26 a. Advancing Models for Environmental Risks 27 b. Improving Data Sourcing, Generation, and Evaluation 27 c. Persistent, Bioaccumulative and Toxic (PBT) Substances 28 XIII. EPA Should Leverage International and Inter-Agency Cooperation 28 XIV. Incorporating High Throughput Tools and Alternative Methods 29 XV. Stakeholders and EPA Must Be Held to the Same High Standard 30 APPENDIX A: ACC's Principles for Improving Chemical Hazard and Risk Assessment 31 APPENDIX B: Improving Hazard Assessment 32 APPENDIX C: Improving Does Response Assessment 33 APPRNDIX D: Improving Risk Characterization 35 APPENDIX E: Ensuring Robust Peer Review 37 APPENDIX F: Exposure Modeling Tools 39 APPENDIX G: Additional Information on the ECETOC TRA 41 3 I P a 3 e Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 I. Introduction and Executive Summary The American Chemistry Council (ACC)2 is pleased to provide the U.S. Environmental Protection Agency (EPA) this initial input on the Lautenberg Chemical Safety Act's (LCSA) requirement for the Agency to establish, by rule, the process for conducting risk evaluations. ACC appreciates EPA's early efforts to obtain input from stakeholders at its August 9, 2016, public meeting. We also appreciate EPA's solicitation of written comments to be entered into the docket, well in advance of publication of the proposed rule. Our comments both clarify, as well as supplement and expand upon, the oral comments we presented at the August 9 meeting. ACC strongly supported Congress' efforts to update and reform the Toxic Substances Control Act (TSCA). We believe that high quality risk evaluation, using best available science and weight of the evidence (WoE), is at the very heart of the LCSA. Effective and efficient risk evaluations will help deliver the results intended by Congress. Section 6(b)(4)(B) of the statute requires EPA to establish, by rule, "a process to conduct risk evaluations.' This certainly should include a description of the sequence of events, timelines, opportunities for public comments and peer review. Both Sections 6 and 26 of the LCSA outline various substantive elements that apply to and inform risk evaluation. A risk evaluation must: Be conducted in a manner designed to determine "whether a chemical substance presents an unreasonable risk of injury to health or the environment;" as set out in Section 6(b)(4)(A); Identify whether there exists "an unreasonable risk to a potentially exposed or susceptible subpopulation." EPA must identify potentially exposed or susceptible subpopulations relevant to the risk evaluation under conditions of use; Address the specific elements set out in Section 6(b)(4)(F); and Comply with the specific requirements of Section 26, including the best available science, weight of the evidence, and transparency requirements. Because these elements are at the core of the risk evaluation process, and affect risk management measures, they are substantive and should be described in adequate detail in the regulation. In general, where risk evaluation elements are now required by statute, EPA should apply them uniformly and universally reflecting them in the body of the regulation. The recommendations provided by ACC in these comments address screening and refined risk evaluations and are meant to apply to both human health and environmental risks. Specific tools, testing methods, databases, and the like may develop over time, or course, and can be updated as necessary in policies, 2 The American Chemistry Council (ACC) represents the leading companies engaged in the business of chemistry. ACC members apply the science of chemistry to make innovative products and services that make people's lives better, healthier and safer. ACC is committed to improved environmental, health and safety performance through Responsible Care common sense advocacy designed to address major public policy issues, and health and environmental research and product testing. The business of chemistry is a $797 billion enterprise and a key element of the nation's economy. It is the nation's largest exporter, accounting for fourteen percent of all U.S. exports. Chemistry companies are among the largest investors in research and development. Safety and security have always been primary concerns of ACC members, and they have intensified their efforts, working closely with government agencies to improve security and to defend against any threat to the nation's critical infrastructure. 4 Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 procedures and guidance. Our comments strive to make these differentiations and explain where particular elements of risk evaluation should be included in the rule proper. Specifically, our recommendations suggest definitions, and procedural steps and elements that will allow EPA to ensure that risk evaluations are consistent with the statutory requirements for EPA to use the best available science and WoE approaches. The recommendations also include definitions and procedural steps are not expected to change over time. ACC has referenced each of our suggestions to an existing EPA guidance, a National Academies (NAS) report, or another authoritative body or peer reviewed report. For instance, the recommendations in EPA's 2000 Risk Characterization Handbook still represent best practices today. Adding adequate definitions and explanation to the rule is particularly important to achieving incorporation of statutory requirements. We also note that in addition to Section 6, Sections 26(h), 26(i), 26(j), and 26(k) of the LCSA each present legal requirements that are applicable to the risk evaluation. EPA will now need to provide a level of transparency regarding not only the inputs, but also the methods of the analysis, including clear descriptions of uncertainties and variability. EPA should leverage information from other jurisdictions where data and information is applicable and of sufficient quality to meet the science standards in the LCSA. Incorporating these elements into the rulemaking creates a better platform for clear and consistent articulation of the Agency's understanding of statutory requirements, and will better support consistent and uniform application of the elements of risk evaluation. It is critically important that EPA engage the public as EPA plans, scopes, and conducts risk evaluations. Industry scientists often have unique insight and experience with their companies' chemistries and collectively have a large body of knowledge of risk assessment processes globally, including an understanding of potential human health and environmental impacts. ACC encourages EPA to leverage this knowledge and engage early (well before draft risk evaluations are released) and frequently with industry throughout the risk evaluation process. II. The Risk Evaluation Rulemaking Must Include both Procedural and Substantive Elements to Effect the Purposes of the Statute Congress included a specific mandate to EPA to establish a risk evaluation rulemaking. There is little question that the rule must describe the process by which risk evaluations will be conducted. However, to 3 effect the purposes of the statute, the process described in the rule cannot merely set out timelines or the sequence of the risk evaluation. It must include a clear articulation of the substantive elements of risk evaluation, and more particularly, it must explain how it will apply the principles set out in Section 6(b)(4)(F), Section 26, and other parts of the statute. If Congress had intended the scientific standard of "best available science" or "weight of the scientific evidence" to be incorporated into guidance alone, it would have included them only in Section 26(1) on "policies, procedures and guidance." 3 "[T]he Administrator shall establish, by rule, a process to conduct risk evaluations in accordance with subparagraph (A) " Section 6(b)(4)(A). 5 I Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 The very purpose of the risk evaluation is to develop the evidentiary and scientific basis to enable EPA to complete the risk determination required by statute. That risk determination has substantive impact - it significantly affects conduct, activity or a substantive interest that is the subject of agency regulation. The determination following risk evaluation is a necessary prerequisite for a chemical to proceed to risk management, if warranted. The rule should thus include a clear description of how EPA will undertake risk evaluations in order to meet the new statutory requirements of the LCSA. This includes a description of the scoping process and requirements for a published scope as well as the elements of the risk evaluation itself and the mechanism for gauging adequacy as measured against statutory criteria. III. The Proposed Rule Should Include a Tiered Approach to Risk Evaluation We believe the statute contemplates a tiered approach to risk evaluation and recommend that EPA include a tiered approach in the rule. Under the LCSA, EPA must initiate the risk evaluation "upon designating" a chemical as a high-priority substance. The scope, however, is not required to be published "upon initiation" -- EPA has up to six months following the initiation of the risk evaluation to prepare and publish the scope. Congress intended this six month period to be used for a scoping exercise, where EPA identifies "the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations the Administrator expects to consider in the risk evaluation." This six month period is a "step" between the high priority designation and the publication of the scope. In order for EPA to conduct risk evaluations consistent with the quality required by the LCSA and within the timeframes required, EPA should conduct a screening level evaluation during the scoping phase. During the scoping phase of risk evaluations, tools exist to allow EPA to conduct quantitative screening level analyses of multiple exposure scenarios, as appropriate for consumers, sensitive subpopulations, and the environment. This will allow EPA to have a more tailored focus on those populations and exposures of greatest concern during a refined risk evaluation process. Figure 1 below depicts ACC's recommended approach. 6 I Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 - y 10 Worknlan High-Duality Refined Risk Evaluation High Pricrity Chemicats & DRAFT Chemicals Manufacturer Risk Evaluation Requested EXPOSSURES HAZARD Evaluation incorporating Sections 6 and 26 of the Lautenberg Chemicel Safety Act (LCSA): Scope/Screening Level Risk Evatuation Scientific Standards FINAL Susceprible Weight of Scientific Evidence Evaluations Risk Evaluation Exposures Pupulations or use Certain Conditions of Use Present Do not present an anreasonable risk an unreasonable risk Refined No further risk evaluation risk avaluation No further action; needed RUREMAKING PROCESS COMPLETE the Figure 1. A Two-Step Process for Conducting Risk Evaluations Note: This is a simplified version of the process. A tiered approach, where EPA uses the scoping step (step 1) to conduct a quantitative screening level analysis, will allow EPA to focus its limited resources on more robust refined risk evaluations for only those conditions of use where unreasonable risks cannot be ruled out. Screening-level assessments require less data and information, and are typically deterministic and based on conservative, health protective assumptions and methods. When a screening assessment indicates low risk for a particular condition of use, the Agency should have a high degree of confidence that the potential risks are much lower than the calculation and, therefore, the actual risks are lower and/or perhaps non-existent. However, when a screening-level risk assessment indicates a potential concern for an adverse effect, this does not mean that the actual risks are significant and warrant action. Rather, it indicates the Agency should take a second step in the risk evaluation process to refine the evaluation to more accurately quantify potential risks. The refined risk evaluation (step 2) will require realistic and representative data, higher tier modeling approaches, including probabilistic exposure modeling, and a more comprehensive consideration of human relevance and dose-response relationships. In a refined evaluation, EPA should also consider targeted exposure studies, as well as biomonitoring and environmental monitoring data, to the extent that this information is available and relevant. This approach is consistent with EPA's 2014 Framework for Human Health Risk Assessment to Inform Decision Making (HHRA Framework)4. which also emphasizes the importance of a fit-for-purpose approach to risk evaluation. This approach is also consistent with EPA's exposure assessment guidelines and practices. The concept of a tiered approach and a fit-for-purpose 5 evaluation are woven throughout ACC's recommendations. 4 See tps://www.epa.gov/sites/production/files/2014-12/documents/hhra-framework-final-2014.pdf. 5 See: tps://www.epa.gov/expobox/exposure-assessment-tools-tiers-and-types-screening-level-and-refined. 7 Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 The tiered approach ACC recommends is consistent with the approach EPA took in the problem formulation and initial assessment document for tetrabromobisphenol A (TBBPA.6 In that document, EPA conducted an initial screening level evaluation to support its conceptual model and analysis plan. EPA appropriately used high-end exposure values coupled with the lowest toxicity values to evaluate uses and exposure pathways of potential concern. While EPA did not share the relevant risk evaluation calculations in its public document, the general approach is consistent with that of a screening level risk evaluation. ACC encourages EPA to continue with this approach and to transparently and clearly present quantitative screening level analyses for the conditions of use and exposure scenarios that are part of the conceptual model EPA develops as part of the scoping phase. IV. The Rule Should Clarify the Process for Preparation and Contents of the Scope As noted above, Congress allowed a six month period for preparation of the scope of the risk evaluation, contemplating that time and effort would be needed to move from prioritization to a published scope. The six month period is to enable EPA to identify "the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations the Administrator expects to consider in the risk evaluation." Two things are evident from this language and the time frame afforded: 1) EPA should use this period to evaluate and decide which, if any, potentially exposed or susceptible subpopulations should be included in the risk evaluation (in other words, it need not include all such subpopulations, regardless of size, impact, or relevance); and 2) tEPA has flexibility to actually conduct a full risk evaluation of some or all the potential scenarios set out in the scope. In short, EPA need not include every conceivable condition of use in a risk evaluation. This view is further buttressed by the definition of "conditions of use" in Section 3 of the LCSA, which points to the need for EPA to determine the relevant conditions of use: "the circumstances, as determined by the Administrator, under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of." (Emphasis added). V. The Proposed Rule Should Include a Detailed Description of Substantive Elements of Risk Evaluation The term, "risk evaluation" is not expressly defined in the LCSA. While the term "risk assessment" has been widely used in EPA programs and operationally has clear meaning derived from years of guidance, policies and practices, that term was not used in the statute. Therefore even though it may be reasonable to assume "risk evaluation" may fully equate with the term "risk assessment," given the context of its use (integrating hazard with exposure) in the LCSA, EPA is encouraged to explicitly define and operationalize this term as part of its rulemaking. The term will not have clear meaning until an interpretation is assigned by EPA. We believe the essential elements of a Section 6 and 26 risk evaluation must be articulated in a clear regulatory definition as we discuss below. 6 EPA, Problem Formulation and Initial Assessment Tetrabromobisphenol A and Related Chemicals Cluster Flame Retardants, 2015, available at: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/tsca-work-plan-chemical-problem- formulation-and-2. 8 IPage Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 Section 6(b)(4)(B) of the statute requires EPA to establish, by rule, "a process to conduct risk evaluations." This process is itself required to meet a number of substantive elements described in the LCSA; a risk evaluation must: Be conducted in a manner designed to help the agency determine "whether a chemical substance presents an unreasonable risk of injury to health or the environment;" as set out in Section 6(b)(4)(A). Include consideration of "an unreasonable risk to a potentially exposed or susceptible subpopulation." EPA must identify relevant potentially exposed or susceptible subpopulations relevant to the risk evaluation under conditions of use; Address the specific elements set out in Section 6(b)(4)(F); and Comply with the specific requirements of Section 26, including the best available science, weight of the evidence, and transparency requirements. The very purpose of the risk evaluation is to develop the evidentiary and scientific basis to enable EPA to complete the risk determination required by statute. That risk determination has substantive impact - it significantly affects conduct, activity or a substantive interest that is the subject of agency regulation. The basis for the risk determination thus should be adequately described in the rule itself to offer sufficient notice to the regulated community. This is particularly important for decisions that inform safety and safety determinations. Likewise, decisions that have broad reaching impact should be supported in regulations, not merely through guidance or agency policy. 8 While EPA cannot substitute policy or guidance for a regulatory description of what will constitute a complete and robust risk evaluation, we believe the necessary elements can be developed in this rulemaking in a timely manner. VI. The Proposed Rule Should Ensure Consistency with Section 6(b)(4)(F) As discussed below, Section 6(b)(4)(F) of the LCSA describes five requirements for risk evaluations that shall be considered by the Administrator and must be incorporated into the risk evaluation rulemaking. 7 See, e.g., MST Express v. U.S. Department of Transportation, 108 F.3d 401 (D.C. Cir. 1997). DOT was directed under the Motor Carrier Safety Act (MCSA) to "prescribe regulations establishing a procedure to decide on the safety fitness of owners and operators of commercial motor vehicles." [Emphasis added]. The MCSA stated that implementing regulations would include "a means of deciding whether the owners, operators, and persons meet the safety fitness requirements." DOT promulgated regulations that set out a process for decision making but used guidance to articulate the tests by which the agency would determine whether vehicles met the safety fitness requirements. The court rejected DOT's reliance on guidance because it "failed to carry out its statutory obligation to establish by regulation a means of determining whether a carrier has complied with the safety fitness requirements." 8 As a general matter, "...it seems to be established that "regulations,' 'substantive rules' or 'legislative rules' are those which create law, usually implementary to an existing law." Gibson Wine Co. v. Snyder, 194 F.2d 329, 331 (D.C. Cir. 1952), cited by Brown Express, Inc. v. U.S., 607 F.2d 695, 700 (5th Cir. 1979). A "rule" is defined under Section 2 of the Administrative Procedure Act, in relevant part, as: "the whole or part of an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy or describing the organization, procedure, or practice requirements of an agency." 5 U.S.C. § 551(4). 9 I Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226

What is the date mentioned in this letter?

ylcn0226

ylcn0226_p0, ylcn0226_p1, ylcn0226_p2, ylcn0226_p3, ylcn0226_p4, ylcn0226_p5, ylcn0226_p6, ylcn0226_p7, ylcn0226_p8, ylcn0226_p9

August 24, 2016

Search 1/19/17 snapshot Assessing and Managing Chemicals under TSCA Contact Us Share Assessing and Managing Chemicals under The Frank R. Lautenberg TSCA Home Chemical Safety for the How EPA Assesses Chemical Safety 2 1st Century Act Assessments for TSCA Work Plan Chemicals On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for Sign up for Current Chemical the 21st Century Act which amends the Toxic TSCA and Risk Reduction Activities Other Substances Control Act (ISCA), the Nation's Chemical ChemView primary chemicals management law. Safety News Chemical Data Reporting The new law, which received bipartisan support in both the U.S. House of Representatives and Getemail alerts the Senate, includes much needed improvements such as: Enter email address sign up Mandatory requirement for EPA to evaluate existing chemicals with clear and enforceable deadlines; New risk-based safety standard; Increased public transparency for chemical information; and Recent Consistent source of funding for EPA to carry additions out the responsibilities under the new law. Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 American" Chemistry Council August 24, 2016 Wendy Cleland-Hamnett Director, Office of Pollution Prevention and Toxics Environmental Protection Agency 1200 Pennsylvania Ave. NW Washington, DC 20460-0001 Sent electronically to www.regulations.gov docket # EPA-HQ-OPPT-2016-0400 Re: ACC Comments to Inform EPA's Rulemaking on the Conduct of Risk Evaluations under the Lautenberg Chemical Safety Act Dear Ms. Cleland-Hamnett: The American Chemistry Council (ACC¹ appreciates the opportunity to provide input to the Office of Pollution Prevention and Toxics to inform the Agency's development of a risk evaluation rulemaking under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (LCSA). ACC has a long-standing commitment to a robust, science-based approach to evaluation of human and environmental risk. ACC is committed to the effective implementation of the LCSA and supports a workable, rigorous process that allows for timely, high quality reviews. Given the strong emphasis on a risk-based approach in the LCSA, the Section 6(b)(4) rulemaking is particularly important because it will guide the conduct of future risk evaluations that will then inform risk management activities. ACC is committed to being a constructive stakeholder throughout the implementation of LCSA. We will continue to draw from the breadth and depth of our member companies' expertise to ensure that our recommendations are not only science-based, but also allow for the efficient and effective implementation of the LCSA. In doing so, ACC will continue to consider the high quality science standards in the LCSA as well as the timeframes and deadlines imposed therein. The enclosed recommendations were developed with these important considerations in mind. If EPA has any questions, please contact me at nancy [email protected] or 202-249-6417. Sincerely, Nancy B. Beck, PhD, DABT Senior Director, Regulatory and Technical Affairs Cc: Jim Jones, OCSPP Assistant Administrator Louise Wise, Deputy Assistant Administrator Jeffery Morris, Deputy Director for Programs, OPPT Tala Henry, Director, Risk Assessment Division, OPPT 1 The American Chemistry Council (ACC) represents the leading companies engaged in the business of chemistry. More information about ACC is presented in the body of our comments. 1 IPage Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 American Chemistry Council Initial Input to U.S. Environmental Protection Agency In Regard to the Risk Evaluation Rule under the Lautenberg Chemical Safety Act Table of Contents I. Introduction and Executive Summary 4 II. The Risk Evaluation Rulemaking Must Include both Procedural And Substantive Elements to Effect the Purposes of the Statute 5 III. The Proposed Rule Should Include a Tiered Approach to Risk Evaluation 6 IV. The Rule Should Clarify the Process for Preparation and Contents of the Scope 8 V. The Proposed Rule Should Include a Detailed Description of Substantive Elements of Risk Evaluation 8 VI. Proposed Rule Should Ensure Consistency with Section 6(b)(4)(F) 9 a. Integration and Assessment of Information Relevant to Risks and Information on Potentially Exposed and Susceptible Populations 10 i. Conditions of Use That are Relevant 10 ii. Potentially Exposed or Susceptible Subpopulations 10 b. Aggregate and Sentinel Exposures 12 i. Aggregate Exposures 12 ii. Sentinel Exposures 12 c. Exposure Assessment 13 d. Weight of the Evidence 14 VII. The Proposed Rule Should Incorporate Section 26(h) Scientific Standards 14 a. Fit-for-Purpose Approach 15 b. Consideration of Relevant Information 16 i. Improving Hazard Assessment 16 ii. Improving Dose Response Assessment 17 iii. Reliance on Guidance 17 c. Importance of High Quality Risk Characterization 18 d. Clearly Addressing Variability and Uncertainty 18 e. Ensuring Appropriate Peer Review and Forming a Science Advisory Committee on Chemicals 19 21 Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 VIII. The Proposed Rule Should Implement a Weight of the Scientific Evidence (WoE) Approach 20 a. Systematic Review is Required 20 i. Development of a Protocol 21 ii. Search Strategy 21 iii. Transparency 21 b. A Systematic Review is Not Automatically a WoE Assessment 21 c. WoE and Systematic Review for Screening Level Risk Evaluations 22 d. WoE and Systematic Review for Refined Risk Evaluations 22 e. Strength of Evidence is Not the Same as WoE 23 IX. EPA Should Make Information Available Consistent with Section 26(j) 24 X. EPA Should Use Reasonably Available Information and CBI Consistent with Section 26(k) 24 XI. EPA Should Utilize Fit-for-Purpose Exposure Evaluation Tools 25 XII. The Requirements of Sections 6 and 26 Apply to Environmental Risk Evaluations 26 a. Advancing Models for Environmental Risks 27 b. Improving Data Sourcing, Generation, and Evaluation 27 c. Persistent, Bioaccumulative and Toxic (PBT) Substances 28 XIII. EPA Should Leverage International and Inter-Agency Cooperation 28 XIV. Incorporating High Throughput Tools and Alternative Methods 29 XV. Stakeholders and EPA Must Be Held to the Same High Standard 30 APPENDIX A: ACC's Principles for Improving Chemical Hazard and Risk Assessment 31 APPENDIX B: Improving Hazard Assessment 32 APPENDIX C: Improving Does Response Assessment 33 APPRNDIX D: Improving Risk Characterization 35 APPENDIX E: Ensuring Robust Peer Review 37 APPENDIX F: Exposure Modeling Tools 39 APPENDIX G: Additional Information on the ECETOC TRA 41 3 I P a 3 e Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 I. Introduction and Executive Summary The American Chemistry Council (ACC)2 is pleased to provide the U.S. Environmental Protection Agency (EPA) this initial input on the Lautenberg Chemical Safety Act's (LCSA) requirement for the Agency to establish, by rule, the process for conducting risk evaluations. ACC appreciates EPA's early efforts to obtain input from stakeholders at its August 9, 2016, public meeting. We also appreciate EPA's solicitation of written comments to be entered into the docket, well in advance of publication of the proposed rule. Our comments both clarify, as well as supplement and expand upon, the oral comments we presented at the August 9 meeting. ACC strongly supported Congress' efforts to update and reform the Toxic Substances Control Act (TSCA). We believe that high quality risk evaluation, using best available science and weight of the evidence (WoE), is at the very heart of the LCSA. Effective and efficient risk evaluations will help deliver the results intended by Congress. Section 6(b)(4)(B) of the statute requires EPA to establish, by rule, "a process to conduct risk evaluations.' This certainly should include a description of the sequence of events, timelines, opportunities for public comments and peer review. Both Sections 6 and 26 of the LCSA outline various substantive elements that apply to and inform risk evaluation. A risk evaluation must: Be conducted in a manner designed to determine "whether a chemical substance presents an unreasonable risk of injury to health or the environment;" as set out in Section 6(b)(4)(A); Identify whether there exists "an unreasonable risk to a potentially exposed or susceptible subpopulation." EPA must identify potentially exposed or susceptible subpopulations relevant to the risk evaluation under conditions of use; Address the specific elements set out in Section 6(b)(4)(F); and Comply with the specific requirements of Section 26, including the best available science, weight of the evidence, and transparency requirements. Because these elements are at the core of the risk evaluation process, and affect risk management measures, they are substantive and should be described in adequate detail in the regulation. In general, where risk evaluation elements are now required by statute, EPA should apply them uniformly and universally reflecting them in the body of the regulation. The recommendations provided by ACC in these comments address screening and refined risk evaluations and are meant to apply to both human health and environmental risks. Specific tools, testing methods, databases, and the like may develop over time, or course, and can be updated as necessary in policies, 2 The American Chemistry Council (ACC) represents the leading companies engaged in the business of chemistry. ACC members apply the science of chemistry to make innovative products and services that make people's lives better, healthier and safer. ACC is committed to improved environmental, health and safety performance through Responsible Care common sense advocacy designed to address major public policy issues, and health and environmental research and product testing. The business of chemistry is a $797 billion enterprise and a key element of the nation's economy. It is the nation's largest exporter, accounting for fourteen percent of all U.S. exports. Chemistry companies are among the largest investors in research and development. Safety and security have always been primary concerns of ACC members, and they have intensified their efforts, working closely with government agencies to improve security and to defend against any threat to the nation's critical infrastructure. 4 Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 procedures and guidance. Our comments strive to make these differentiations and explain where particular elements of risk evaluation should be included in the rule proper. Specifically, our recommendations suggest definitions, and procedural steps and elements that will allow EPA to ensure that risk evaluations are consistent with the statutory requirements for EPA to use the best available science and WoE approaches. The recommendations also include definitions and procedural steps are not expected to change over time. ACC has referenced each of our suggestions to an existing EPA guidance, a National Academies (NAS) report, or another authoritative body or peer reviewed report. For instance, the recommendations in EPA's 2000 Risk Characterization Handbook still represent best practices today. Adding adequate definitions and explanation to the rule is particularly important to achieving incorporation of statutory requirements. We also note that in addition to Section 6, Sections 26(h), 26(i), 26(j), and 26(k) of the LCSA each present legal requirements that are applicable to the risk evaluation. EPA will now need to provide a level of transparency regarding not only the inputs, but also the methods of the analysis, including clear descriptions of uncertainties and variability. EPA should leverage information from other jurisdictions where data and information is applicable and of sufficient quality to meet the science standards in the LCSA. Incorporating these elements into the rulemaking creates a better platform for clear and consistent articulation of the Agency's understanding of statutory requirements, and will better support consistent and uniform application of the elements of risk evaluation. It is critically important that EPA engage the public as EPA plans, scopes, and conducts risk evaluations. Industry scientists often have unique insight and experience with their companies' chemistries and collectively have a large body of knowledge of risk assessment processes globally, including an understanding of potential human health and environmental impacts. ACC encourages EPA to leverage this knowledge and engage early (well before draft risk evaluations are released) and frequently with industry throughout the risk evaluation process. II. The Risk Evaluation Rulemaking Must Include both Procedural and Substantive Elements to Effect the Purposes of the Statute Congress included a specific mandate to EPA to establish a risk evaluation rulemaking. There is little question that the rule must describe the process by which risk evaluations will be conducted. However, to 3 effect the purposes of the statute, the process described in the rule cannot merely set out timelines or the sequence of the risk evaluation. It must include a clear articulation of the substantive elements of risk evaluation, and more particularly, it must explain how it will apply the principles set out in Section 6(b)(4)(F), Section 26, and other parts of the statute. If Congress had intended the scientific standard of "best available science" or "weight of the scientific evidence" to be incorporated into guidance alone, it would have included them only in Section 26(1) on "policies, procedures and guidance." 3 "[T]he Administrator shall establish, by rule, a process to conduct risk evaluations in accordance with subparagraph (A) " Section 6(b)(4)(A). 5 I Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 The very purpose of the risk evaluation is to develop the evidentiary and scientific basis to enable EPA to complete the risk determination required by statute. That risk determination has substantive impact - it significantly affects conduct, activity or a substantive interest that is the subject of agency regulation. The determination following risk evaluation is a necessary prerequisite for a chemical to proceed to risk management, if warranted. The rule should thus include a clear description of how EPA will undertake risk evaluations in order to meet the new statutory requirements of the LCSA. This includes a description of the scoping process and requirements for a published scope as well as the elements of the risk evaluation itself and the mechanism for gauging adequacy as measured against statutory criteria. III. The Proposed Rule Should Include a Tiered Approach to Risk Evaluation We believe the statute contemplates a tiered approach to risk evaluation and recommend that EPA include a tiered approach in the rule. Under the LCSA, EPA must initiate the risk evaluation "upon designating" a chemical as a high-priority substance. The scope, however, is not required to be published "upon initiation" -- EPA has up to six months following the initiation of the risk evaluation to prepare and publish the scope. Congress intended this six month period to be used for a scoping exercise, where EPA identifies "the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations the Administrator expects to consider in the risk evaluation." This six month period is a "step" between the high priority designation and the publication of the scope. In order for EPA to conduct risk evaluations consistent with the quality required by the LCSA and within the timeframes required, EPA should conduct a screening level evaluation during the scoping phase. During the scoping phase of risk evaluations, tools exist to allow EPA to conduct quantitative screening level analyses of multiple exposure scenarios, as appropriate for consumers, sensitive subpopulations, and the environment. This will allow EPA to have a more tailored focus on those populations and exposures of greatest concern during a refined risk evaluation process. Figure 1 below depicts ACC's recommended approach. 6 I Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 - y 10 Worknlan High-Duality Refined Risk Evaluation High Pricrity Chemicats & DRAFT Chemicals Manufacturer Risk Evaluation Requested EXPOSSURES HAZARD Evaluation incorporating Sections 6 and 26 of the Lautenberg Chemicel Safety Act (LCSA): Scope/Screening Level Risk Evatuation Scientific Standards FINAL Susceprible Weight of Scientific Evidence Evaluations Risk Evaluation Exposures Pupulations or use Certain Conditions of Use Present Do not present an anreasonable risk an unreasonable risk Refined No further risk evaluation risk avaluation No further action; needed RUREMAKING PROCESS COMPLETE the Figure 1. A Two-Step Process for Conducting Risk Evaluations Note: This is a simplified version of the process. A tiered approach, where EPA uses the scoping step (step 1) to conduct a quantitative screening level analysis, will allow EPA to focus its limited resources on more robust refined risk evaluations for only those conditions of use where unreasonable risks cannot be ruled out. Screening-level assessments require less data and information, and are typically deterministic and based on conservative, health protective assumptions and methods. When a screening assessment indicates low risk for a particular condition of use, the Agency should have a high degree of confidence that the potential risks are much lower than the calculation and, therefore, the actual risks are lower and/or perhaps non-existent. However, when a screening-level risk assessment indicates a potential concern for an adverse effect, this does not mean that the actual risks are significant and warrant action. Rather, it indicates the Agency should take a second step in the risk evaluation process to refine the evaluation to more accurately quantify potential risks. The refined risk evaluation (step 2) will require realistic and representative data, higher tier modeling approaches, including probabilistic exposure modeling, and a more comprehensive consideration of human relevance and dose-response relationships. In a refined evaluation, EPA should also consider targeted exposure studies, as well as biomonitoring and environmental monitoring data, to the extent that this information is available and relevant. This approach is consistent with EPA's 2014 Framework for Human Health Risk Assessment to Inform Decision Making (HHRA Framework)4. which also emphasizes the importance of a fit-for-purpose approach to risk evaluation. This approach is also consistent with EPA's exposure assessment guidelines and practices. The concept of a tiered approach and a fit-for-purpose 5 evaluation are woven throughout ACC's recommendations. 4 See tps://www.epa.gov/sites/production/files/2014-12/documents/hhra-framework-final-2014.pdf. 5 See: tps://www.epa.gov/expobox/exposure-assessment-tools-tiers-and-types-screening-level-and-refined. 7 Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 The tiered approach ACC recommends is consistent with the approach EPA took in the problem formulation and initial assessment document for tetrabromobisphenol A (TBBPA.6 In that document, EPA conducted an initial screening level evaluation to support its conceptual model and analysis plan. EPA appropriately used high-end exposure values coupled with the lowest toxicity values to evaluate uses and exposure pathways of potential concern. While EPA did not share the relevant risk evaluation calculations in its public document, the general approach is consistent with that of a screening level risk evaluation. ACC encourages EPA to continue with this approach and to transparently and clearly present quantitative screening level analyses for the conditions of use and exposure scenarios that are part of the conceptual model EPA develops as part of the scoping phase. IV. The Rule Should Clarify the Process for Preparation and Contents of the Scope As noted above, Congress allowed a six month period for preparation of the scope of the risk evaluation, contemplating that time and effort would be needed to move from prioritization to a published scope. The six month period is to enable EPA to identify "the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations the Administrator expects to consider in the risk evaluation." Two things are evident from this language and the time frame afforded: 1) EPA should use this period to evaluate and decide which, if any, potentially exposed or susceptible subpopulations should be included in the risk evaluation (in other words, it need not include all such subpopulations, regardless of size, impact, or relevance); and 2) tEPA has flexibility to actually conduct a full risk evaluation of some or all the potential scenarios set out in the scope. In short, EPA need not include every conceivable condition of use in a risk evaluation. This view is further buttressed by the definition of "conditions of use" in Section 3 of the LCSA, which points to the need for EPA to determine the relevant conditions of use: "the circumstances, as determined by the Administrator, under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of." (Emphasis added). V. The Proposed Rule Should Include a Detailed Description of Substantive Elements of Risk Evaluation The term, "risk evaluation" is not expressly defined in the LCSA. While the term "risk assessment" has been widely used in EPA programs and operationally has clear meaning derived from years of guidance, policies and practices, that term was not used in the statute. Therefore even though it may be reasonable to assume "risk evaluation" may fully equate with the term "risk assessment," given the context of its use (integrating hazard with exposure) in the LCSA, EPA is encouraged to explicitly define and operationalize this term as part of its rulemaking. The term will not have clear meaning until an interpretation is assigned by EPA. We believe the essential elements of a Section 6 and 26 risk evaluation must be articulated in a clear regulatory definition as we discuss below. 6 EPA, Problem Formulation and Initial Assessment Tetrabromobisphenol A and Related Chemicals Cluster Flame Retardants, 2015, available at: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/tsca-work-plan-chemical-problem- formulation-and-2. 8 IPage Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 Section 6(b)(4)(B) of the statute requires EPA to establish, by rule, "a process to conduct risk evaluations." This process is itself required to meet a number of substantive elements described in the LCSA; a risk evaluation must: Be conducted in a manner designed to help the agency determine "whether a chemical substance presents an unreasonable risk of injury to health or the environment;" as set out in Section 6(b)(4)(A). Include consideration of "an unreasonable risk to a potentially exposed or susceptible subpopulation." EPA must identify relevant potentially exposed or susceptible subpopulations relevant to the risk evaluation under conditions of use; Address the specific elements set out in Section 6(b)(4)(F); and Comply with the specific requirements of Section 26, including the best available science, weight of the evidence, and transparency requirements. The very purpose of the risk evaluation is to develop the evidentiary and scientific basis to enable EPA to complete the risk determination required by statute. That risk determination has substantive impact - it significantly affects conduct, activity or a substantive interest that is the subject of agency regulation. The basis for the risk determination thus should be adequately described in the rule itself to offer sufficient notice to the regulated community. This is particularly important for decisions that inform safety and safety determinations. Likewise, decisions that have broad reaching impact should be supported in regulations, not merely through guidance or agency policy. 8 While EPA cannot substitute policy or guidance for a regulatory description of what will constitute a complete and robust risk evaluation, we believe the necessary elements can be developed in this rulemaking in a timely manner. VI. The Proposed Rule Should Ensure Consistency with Section 6(b)(4)(F) As discussed below, Section 6(b)(4)(F) of the LCSA describes five requirements for risk evaluations that shall be considered by the Administrator and must be incorporated into the risk evaluation rulemaking. 7 See, e.g., MST Express v. U.S. Department of Transportation, 108 F.3d 401 (D.C. Cir. 1997). DOT was directed under the Motor Carrier Safety Act (MCSA) to "prescribe regulations establishing a procedure to decide on the safety fitness of owners and operators of commercial motor vehicles." [Emphasis added]. The MCSA stated that implementing regulations would include "a means of deciding whether the owners, operators, and persons meet the safety fitness requirements." DOT promulgated regulations that set out a process for decision making but used guidance to articulate the tests by which the agency would determine whether vehicles met the safety fitness requirements. The court rejected DOT's reliance on guidance because it "failed to carry out its statutory obligation to establish by regulation a means of determining whether a carrier has complied with the safety fitness requirements." 8 As a general matter, "...it seems to be established that "regulations,' 'substantive rules' or 'legislative rules' are those which create law, usually implementary to an existing law." Gibson Wine Co. v. Snyder, 194 F.2d 329, 331 (D.C. Cir. 1952), cited by Brown Express, Inc. v. U.S., 607 F.2d 695, 700 (5th Cir. 1979). A "rule" is defined under Section 2 of the Administrative Procedure Act, in relevant part, as: "the whole or part of an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy or describing the organization, procedure, or practice requirements of an agency." 5 U.S.C. § 551(4). 9 I Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226

mention the date which is on right side top of the letter

klcn0226

klcn0226_p0, klcn0226_p1

june 15,2006, JUNE 15, 2006

American Chemistry Council Gand " Porsible Dr. Nancy Beck June 15, 2006 Office of Information and Regulatory Affairs Office of Management and Budget 725 17th Street, NW. New Executive Office Building Room 10201 Washington, DC 20503 Re: Comments on Proposed Risk Assessment Bulletin Dear Dr. Beck: The American Chemistry Council (ACC or the Council) is pleased to submit comments on the Office of Management and Budget's Proposed Risk Assessment Bulletin¹. The Council represents the leading companies engaged in the business of chemistry². ACC and its members make substantial, ongoing investments in research to support product development, health, safety and environmental protection, and to abide by product stewardship and regulatory policies. Chemistry is a science-based industry, and ACC has long sought to improve the quality of government science generally and risk assessment in particular. For example, in response to OMB's Draft 2003 Report to Congress on the Costs and Benefits of Federal Regulations, ACC filed an extensive set of comments (63 3 pages plus five appendices) that primarily focused on EPA's risk assessment practices. Appendix 5 to those comments provided 62 additional pages of examples of EPA risk assessments that overstated risks. ACC's comments were the principal drivers behind EPA's 2004 staff paper on the Agency's risk assessment principles and practices - a document which defended the appropriateness of many of the practices to which ACC objected. These controversies are still largely unresolved, and thus ACC has a substantial interest in the Bulletin. 1 Notice of availability at 71 Fed. Reg. 2600 (Jan. 17, 2006). 2 Council members apply the science of chemistry to make innovative products and services that make people's lives better, healthier and safer. The Council is committed to improved environmental, health and safety performance through Responsible R Care common sense advocacy designed to address major public policy issues, and health and environmental research and product testing. The business of chemistry is a $460 billion enterprise and a key element of the nation's economy. It is the nation's largest exporter, accounting for ten cents out of every dollar in U.S. exports. Chemistry companies invest more in research and development than any other business sector. 3 ACC, "Comments to the Office of Management & Budget; Draft 2003 Report to Congress on the Costs and Benefits of Federal Regulations," filed May 5, 2003. These comments and Appendix 5 are attached. 4 EPA Office of the Science Advisor Staff Paper, An Examination of EPA Risk Assessment Principles and Practices (EPA/100/B-04/001) (Feb. 2004). Responsible Care 1300 Wilson Boulevard, Arlington, VA 22209 Tel 703-741-5000 A Fax 703-741-6000 Source: https://www.industrydocuments.ucsf.edu/docs/klcn0226 Dr. Beck June 15, 2006 Page 2 ACC has strongly supported OMB's efforts - through its Information Quality Act (IQA) Guidelines, the 5 Peer Review Bulletin, 6 Circular A-4,7 and otherwise - to assure that the highest quality scientific work products are consistently and assiduously applied in support of regulatory policy. The proposed Risk Assessment Bulletin continues those efforts, and ACC applauds OMB for issuing it. We believe the Bulletin, once finalized, will improve the uneven performance of risk assessments at EPA and other federal agencies by setting a unified, upgraded standard. The attached comments highlight the strengths that we have identified in the document, and recommend a number of improvements that we believe are vital to its success. We understand that many important issues associated with the Bulletin will only become clear as it is implemented, and we look forward to a continuing dialogue with OMB before and after its final publication. Should you or other OMB staff have any questions on, or need clarification of, ACC comments, please don't hesitate to contact either of us at 703-741-5000. Sincerely, James W. Conrad, Jr. Richard A. Becker, Ph.D. DABT Assistant General Counsel Senior Toxicologist/Senior Director Attachment: Comments of the American Chemistry Council on the Proposed Risk Assessment Bulletin (released for public review and comment in January, 2006) 5 OMB, Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies, 67 Fed. Reg. 8452 (Feb. 22, 2002). 6 OMB, Final Information Quality Bulletin for Peer Review, 70 Fed. Reg. 2664 (Jan. 14, 2005). 7 OMB, Circular A-4 (Sept. 2003). Source: https://www.industrydocuments.ucsf.edu/docs/klcn0226

what does IQA stands for?

klcn0226

klcn0226_p0, klcn0226_p1

information quality act, INFORMATION QUALITY ACT

American Chemistry Council Gand " Porsible Dr. Nancy Beck June 15, 2006 Office of Information and Regulatory Affairs Office of Management and Budget 725 17th Street, NW. New Executive Office Building Room 10201 Washington, DC 20503 Re: Comments on Proposed Risk Assessment Bulletin Dear Dr. Beck: The American Chemistry Council (ACC or the Council) is pleased to submit comments on the Office of Management and Budget's Proposed Risk Assessment Bulletin¹. The Council represents the leading companies engaged in the business of chemistry². ACC and its members make substantial, ongoing investments in research to support product development, health, safety and environmental protection, and to abide by product stewardship and regulatory policies. Chemistry is a science-based industry, and ACC has long sought to improve the quality of government science generally and risk assessment in particular. For example, in response to OMB's Draft 2003 Report to Congress on the Costs and Benefits of Federal Regulations, ACC filed an extensive set of comments (63 3 pages plus five appendices) that primarily focused on EPA's risk assessment practices. Appendix 5 to those comments provided 62 additional pages of examples of EPA risk assessments that overstated risks. ACC's comments were the principal drivers behind EPA's 2004 staff paper on the Agency's risk assessment principles and practices - a document which defended the appropriateness of many of the practices to which ACC objected. These controversies are still largely unresolved, and thus ACC has a substantial interest in the Bulletin. 1 Notice of availability at 71 Fed. Reg. 2600 (Jan. 17, 2006). 2 Council members apply the science of chemistry to make innovative products and services that make people's lives better, healthier and safer. The Council is committed to improved environmental, health and safety performance through Responsible R Care common sense advocacy designed to address major public policy issues, and health and environmental research and product testing. The business of chemistry is a $460 billion enterprise and a key element of the nation's economy. It is the nation's largest exporter, accounting for ten cents out of every dollar in U.S. exports. Chemistry companies invest more in research and development than any other business sector. 3 ACC, "Comments to the Office of Management & Budget; Draft 2003 Report to Congress on the Costs and Benefits of Federal Regulations," filed May 5, 2003. These comments and Appendix 5 are attached. 4 EPA Office of the Science Advisor Staff Paper, An Examination of EPA Risk Assessment Principles and Practices (EPA/100/B-04/001) (Feb. 2004). Responsible Care 1300 Wilson Boulevard, Arlington, VA 22209 Tel 703-741-5000 A Fax 703-741-6000 Source: https://www.industrydocuments.ucsf.edu/docs/klcn0226 Dr. Beck June 15, 2006 Page 2 ACC has strongly supported OMB's efforts - through its Information Quality Act (IQA) Guidelines, the 5 Peer Review Bulletin, 6 Circular A-4,7 and otherwise - to assure that the highest quality scientific work products are consistently and assiduously applied in support of regulatory policy. The proposed Risk Assessment Bulletin continues those efforts, and ACC applauds OMB for issuing it. We believe the Bulletin, once finalized, will improve the uneven performance of risk assessments at EPA and other federal agencies by setting a unified, upgraded standard. The attached comments highlight the strengths that we have identified in the document, and recommend a number of improvements that we believe are vital to its success. We understand that many important issues associated with the Bulletin will only become clear as it is implemented, and we look forward to a continuing dialogue with OMB before and after its final publication. Should you or other OMB staff have any questions on, or need clarification of, ACC comments, please don't hesitate to contact either of us at 703-741-5000. Sincerely, James W. Conrad, Jr. Richard A. Becker, Ph.D. DABT Assistant General Counsel Senior Toxicologist/Senior Director Attachment: Comments of the American Chemistry Council on the Proposed Risk Assessment Bulletin (released for public review and comment in January, 2006) 5 OMB, Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies, 67 Fed. Reg. 8452 (Feb. 22, 2002). 6 OMB, Final Information Quality Bulletin for Peer Review, 70 Fed. Reg. 2664 (Jan. 14, 2005). 7 OMB, Circular A-4 (Sept. 2003). Source: https://www.industrydocuments.ucsf.edu/docs/klcn0226

who is assistant general counsel?

klcn0226

klcn0226_p0, klcn0226_p1

JAMES W. CONRAD,JR., james w.conrad, Jr.

American Chemistry Council Gand " Porsible Dr. Nancy Beck June 15, 2006 Office of Information and Regulatory Affairs Office of Management and Budget 725 17th Street, NW. New Executive Office Building Room 10201 Washington, DC 20503 Re: Comments on Proposed Risk Assessment Bulletin Dear Dr. Beck: The American Chemistry Council (ACC or the Council) is pleased to submit comments on the Office of Management and Budget's Proposed Risk Assessment Bulletin¹. The Council represents the leading companies engaged in the business of chemistry². ACC and its members make substantial, ongoing investments in research to support product development, health, safety and environmental protection, and to abide by product stewardship and regulatory policies. Chemistry is a science-based industry, and ACC has long sought to improve the quality of government science generally and risk assessment in particular. For example, in response to OMB's Draft 2003 Report to Congress on the Costs and Benefits of Federal Regulations, ACC filed an extensive set of comments (63 3 pages plus five appendices) that primarily focused on EPA's risk assessment practices. Appendix 5 to those comments provided 62 additional pages of examples of EPA risk assessments that overstated risks. ACC's comments were the principal drivers behind EPA's 2004 staff paper on the Agency's risk assessment principles and practices - a document which defended the appropriateness of many of the practices to which ACC objected. These controversies are still largely unresolved, and thus ACC has a substantial interest in the Bulletin. 1 Notice of availability at 71 Fed. Reg. 2600 (Jan. 17, 2006). 2 Council members apply the science of chemistry to make innovative products and services that make people's lives better, healthier and safer. The Council is committed to improved environmental, health and safety performance through Responsible R Care common sense advocacy designed to address major public policy issues, and health and environmental research and product testing. The business of chemistry is a $460 billion enterprise and a key element of the nation's economy. It is the nation's largest exporter, accounting for ten cents out of every dollar in U.S. exports. Chemistry companies invest more in research and development than any other business sector. 3 ACC, "Comments to the Office of Management & Budget; Draft 2003 Report to Congress on the Costs and Benefits of Federal Regulations," filed May 5, 2003. These comments and Appendix 5 are attached. 4 EPA Office of the Science Advisor Staff Paper, An Examination of EPA Risk Assessment Principles and Practices (EPA/100/B-04/001) (Feb. 2004). Responsible Care 1300 Wilson Boulevard, Arlington, VA 22209 Tel 703-741-5000 A Fax 703-741-6000 Source: https://www.industrydocuments.ucsf.edu/docs/klcn0226 Dr. Beck June 15, 2006 Page 2 ACC has strongly supported OMB's efforts - through its Information Quality Act (IQA) Guidelines, the 5 Peer Review Bulletin, 6 Circular A-4,7 and otherwise - to assure that the highest quality scientific work products are consistently and assiduously applied in support of regulatory policy. The proposed Risk Assessment Bulletin continues those efforts, and ACC applauds OMB for issuing it. We believe the Bulletin, once finalized, will improve the uneven performance of risk assessments at EPA and other federal agencies by setting a unified, upgraded standard. The attached comments highlight the strengths that we have identified in the document, and recommend a number of improvements that we believe are vital to its success. We understand that many important issues associated with the Bulletin will only become clear as it is implemented, and we look forward to a continuing dialogue with OMB before and after its final publication. Should you or other OMB staff have any questions on, or need clarification of, ACC comments, please don't hesitate to contact either of us at 703-741-5000. Sincerely, James W. Conrad, Jr. Richard A. Becker, Ph.D. DABT Assistant General Counsel Senior Toxicologist/Senior Director Attachment: Comments of the American Chemistry Council on the Proposed Risk Assessment Bulletin (released for public review and comment in January, 2006) 5 OMB, Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies, 67 Fed. Reg. 8452 (Feb. 22, 2002). 6 OMB, Final Information Quality Bulletin for Peer Review, 70 Fed. Reg. 2664 (Jan. 14, 2005). 7 OMB, Circular A-4 (Sept. 2003). Source: https://www.industrydocuments.ucsf.edu/docs/klcn0226

who is the senior toxicologist/senior director?

klcn0226

klcn0226_p0, klcn0226_p1

Richard A. becker, Ph.D. DABT, RICHARD A. BECKER

American Chemistry Council Gand " Porsible Dr. Nancy Beck June 15, 2006 Office of Information and Regulatory Affairs Office of Management and Budget 725 17th Street, NW. New Executive Office Building Room 10201 Washington, DC 20503 Re: Comments on Proposed Risk Assessment Bulletin Dear Dr. Beck: The American Chemistry Council (ACC or the Council) is pleased to submit comments on the Office of Management and Budget's Proposed Risk Assessment Bulletin¹. The Council represents the leading companies engaged in the business of chemistry². ACC and its members make substantial, ongoing investments in research to support product development, health, safety and environmental protection, and to abide by product stewardship and regulatory policies. Chemistry is a science-based industry, and ACC has long sought to improve the quality of government science generally and risk assessment in particular. For example, in response to OMB's Draft 2003 Report to Congress on the Costs and Benefits of Federal Regulations, ACC filed an extensive set of comments (63 3 pages plus five appendices) that primarily focused on EPA's risk assessment practices. Appendix 5 to those comments provided 62 additional pages of examples of EPA risk assessments that overstated risks. ACC's comments were the principal drivers behind EPA's 2004 staff paper on the Agency's risk assessment principles and practices - a document which defended the appropriateness of many of the practices to which ACC objected. These controversies are still largely unresolved, and thus ACC has a substantial interest in the Bulletin. 1 Notice of availability at 71 Fed. Reg. 2600 (Jan. 17, 2006). 2 Council members apply the science of chemistry to make innovative products and services that make people's lives better, healthier and safer. The Council is committed to improved environmental, health and safety performance through Responsible R Care common sense advocacy designed to address major public policy issues, and health and environmental research and product testing. The business of chemistry is a $460 billion enterprise and a key element of the nation's economy. It is the nation's largest exporter, accounting for ten cents out of every dollar in U.S. exports. Chemistry companies invest more in research and development than any other business sector. 3 ACC, "Comments to the Office of Management & Budget; Draft 2003 Report to Congress on the Costs and Benefits of Federal Regulations," filed May 5, 2003. These comments and Appendix 5 are attached. 4 EPA Office of the Science Advisor Staff Paper, An Examination of EPA Risk Assessment Principles and Practices (EPA/100/B-04/001) (Feb. 2004). Responsible Care 1300 Wilson Boulevard, Arlington, VA 22209 Tel 703-741-5000 A Fax 703-741-6000 Source: https://www.industrydocuments.ucsf.edu/docs/klcn0226 Dr. Beck June 15, 2006 Page 2 ACC has strongly supported OMB's efforts - through its Information Quality Act (IQA) Guidelines, the 5 Peer Review Bulletin, 6 Circular A-4,7 and otherwise - to assure that the highest quality scientific work products are consistently and assiduously applied in support of regulatory policy. The proposed Risk Assessment Bulletin continues those efforts, and ACC applauds OMB for issuing it. We believe the Bulletin, once finalized, will improve the uneven performance of risk assessments at EPA and other federal agencies by setting a unified, upgraded standard. The attached comments highlight the strengths that we have identified in the document, and recommend a number of improvements that we believe are vital to its success. We understand that many important issues associated with the Bulletin will only become clear as it is implemented, and we look forward to a continuing dialogue with OMB before and after its final publication. Should you or other OMB staff have any questions on, or need clarification of, ACC comments, please don't hesitate to contact either of us at 703-741-5000. Sincerely, James W. Conrad, Jr. Richard A. Becker, Ph.D. DABT Assistant General Counsel Senior Toxicologist/Senior Director Attachment: Comments of the American Chemistry Council on the Proposed Risk Assessment Bulletin (released for public review and comment in January, 2006) 5 OMB, Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies, 67 Fed. Reg. 8452 (Feb. 22, 2002). 6 OMB, Final Information Quality Bulletin for Peer Review, 70 Fed. Reg. 2664 (Jan. 14, 2005). 7 OMB, Circular A-4 (Sept. 2003). Source: https://www.industrydocuments.ucsf.edu/docs/klcn0226

which has strongly supported OMB's efforts through its information quality act IQA guidelines?

klcn0226

klcn0226_p0, klcn0226_p1

ACC

American Chemistry Council Gand " Porsible Dr. Nancy Beck June 15, 2006 Office of Information and Regulatory Affairs Office of Management and Budget 725 17th Street, NW. New Executive Office Building Room 10201 Washington, DC 20503 Re: Comments on Proposed Risk Assessment Bulletin Dear Dr. Beck: The American Chemistry Council (ACC or the Council) is pleased to submit comments on the Office of Management and Budget's Proposed Risk Assessment Bulletin¹. The Council represents the leading companies engaged in the business of chemistry². ACC and its members make substantial, ongoing investments in research to support product development, health, safety and environmental protection, and to abide by product stewardship and regulatory policies. Chemistry is a science-based industry, and ACC has long sought to improve the quality of government science generally and risk assessment in particular. For example, in response to OMB's Draft 2003 Report to Congress on the Costs and Benefits of Federal Regulations, ACC filed an extensive set of comments (63 3 pages plus five appendices) that primarily focused on EPA's risk assessment practices. Appendix 5 to those comments provided 62 additional pages of examples of EPA risk assessments that overstated risks. ACC's comments were the principal drivers behind EPA's 2004 staff paper on the Agency's risk assessment principles and practices - a document which defended the appropriateness of many of the practices to which ACC objected. These controversies are still largely unresolved, and thus ACC has a substantial interest in the Bulletin. 1 Notice of availability at 71 Fed. Reg. 2600 (Jan. 17, 2006). 2 Council members apply the science of chemistry to make innovative products and services that make people's lives better, healthier and safer. The Council is committed to improved environmental, health and safety performance through Responsible R Care common sense advocacy designed to address major public policy issues, and health and environmental research and product testing. The business of chemistry is a $460 billion enterprise and a key element of the nation's economy. It is the nation's largest exporter, accounting for ten cents out of every dollar in U.S. exports. Chemistry companies invest more in research and development than any other business sector. 3 ACC, "Comments to the Office of Management & Budget; Draft 2003 Report to Congress on the Costs and Benefits of Federal Regulations," filed May 5, 2003. These comments and Appendix 5 are attached. 4 EPA Office of the Science Advisor Staff Paper, An Examination of EPA Risk Assessment Principles and Practices (EPA/100/B-04/001) (Feb. 2004). Responsible Care 1300 Wilson Boulevard, Arlington, VA 22209 Tel 703-741-5000 A Fax 703-741-6000 Source: https://www.industrydocuments.ucsf.edu/docs/klcn0226 Dr. Beck June 15, 2006 Page 2 ACC has strongly supported OMB's efforts - through its Information Quality Act (IQA) Guidelines, the 5 Peer Review Bulletin, 6 Circular A-4,7 and otherwise - to assure that the highest quality scientific work products are consistently and assiduously applied in support of regulatory policy. The proposed Risk Assessment Bulletin continues those efforts, and ACC applauds OMB for issuing it. We believe the Bulletin, once finalized, will improve the uneven performance of risk assessments at EPA and other federal agencies by setting a unified, upgraded standard. The attached comments highlight the strengths that we have identified in the document, and recommend a number of improvements that we believe are vital to its success. We understand that many important issues associated with the Bulletin will only become clear as it is implemented, and we look forward to a continuing dialogue with OMB before and after its final publication. Should you or other OMB staff have any questions on, or need clarification of, ACC comments, please don't hesitate to contact either of us at 703-741-5000. Sincerely, James W. Conrad, Jr. Richard A. Becker, Ph.D. DABT Assistant General Counsel Senior Toxicologist/Senior Director Attachment: Comments of the American Chemistry Council on the Proposed Risk Assessment Bulletin (released for public review and comment in January, 2006) 5 OMB, Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies, 67 Fed. Reg. 8452 (Feb. 22, 2002). 6 OMB, Final Information Quality Bulletin for Peer Review, 70 Fed. Reg. 2664 (Jan. 14, 2005). 7 OMB, Circular A-4 (Sept. 2003). Source: https://www.industrydocuments.ucsf.edu/docs/klcn0226

What is the location of united states environmental protection agency ?

lpbn0226

lpbn0226_p0, lpbn0226_p1, lpbn0226_p2

Washington, D.C. 20460, WASHINGTON, D.C.

* UNITED STATES ENVIRONMENTAL PROTECTION AGENCY Washington, D.C. 20460 JUN - 8 2017 OFFICE OF GENERAL COUNSEL MEMORANDUM SUBJECT: Participation in Specific Party Matters Involving Your Former Employer, the American Chemistry Council FROM: Kevin S. Minoli use Designated Agency Ethics Official and Acting General Counsel TO: Nancy Beck, Ph.D., DABT Deputy Assistant Administrator Office of Chemical Safety and Pollution Prevention Effective April 30, 2017, you joined the United States Environmental Protection Agency (EPA) in an Administratively Determined (AD) position as the Deputy Assistant Administrator for the Office of Chemical Safety and Pollution Prevention (OCSPP). In this position, you are responsible for advising the Acting Assistant Administrator in matters pertaining to chemical safety, pollution prevention, pesticides and toxie substances, including implementation of rulemaking under applicable federal statutes. Previous to your selection, you served as the Senior Director of Regulatory Science Policy at the American Chemistry Council (ACC), which represents companies that are directly regulated by EPA. You seek permission to participate in specific party matters involving your former employer. In providing my advice, 1 have taken into consideration the fact that, as an AD appointment, you are not required to sign the Trump ethics pledge because this type of appointment falls outside the definition of "appointee" set forth at Executive Order 13,770 at Section 2(b). 1 You do not have any financial conflict of interest with your former employer, so the ethics rules to be applied to you are set forth in the Standards of Ethical Conduct for Employees of the Executive Branch, 5 C.F.R. Part 2635, specifically Subpart E, "Impartiality in Performing Official Duty." Pursuant to 5 C.F.R. § 2635.502(b)(1)(iv), you have a "covered relationship" with ACC as your former employer. For one year from the time you resigned from ACC, absent an impartiality determination from me. you cannot participate in any specific party matter in which ACC is a party or represents a party if that matter is likely to have a direct and predictable financial effect upon the ACC or if the circumstances would cause a reasonable 3 See Office of Government Ethics advisories entitled "Guidance on Executive Order 13770," LA-17-03 (3/20/27) and Executive Order 13770," LA-17-02 (2/6/17), which apply the following OGE advisories from the last administration in full: "Who Must Sign the Ethics Piedge?" DO-09-010 (3/16/09). and "Signing the Ethics Pledge." DO-09-005 (2/10/09). Source: https://www.industrydocuments.ucsf.edu/docs/lpbn0226 person with knowledge of the relevant facts to question your impartiality. See 5 C.F.R. § 2635.502(a). It is important to note that the ethical restriction applies only to particular matters involving specific parties, not to particular matters of general applicability. Generally speaking, a "specific party" matter is a "proceeding affecting the legal rights of parties, or an isolatable transaction or related set of transactions between identified parties." See 5 C.F.R. § 2640.102(1). Rulemaking is not usually a *specific party" matter but rather a matter of general applicability, which involves "deliberation, decision, or action that is focused upon the interests of specific persons, or a discrete and identifiable class of persons." See 5 C.F.R. § 2640.103(a)(1). Therefore, under the ethics regulations, you may participate in rulemaking, even if that rulemaking may affect the members of your former employer. While you can ethically work on rulemaking in general, you have been advised -- and understand that you cannot participate in any meetings, discussions or decisions that relate to any individual ACC comment nor attend any meeting at which ACC is present. As provided by the ethics regulations, however, federal ethics officials can nonetheless permit employees to participate in matters that might raise impartiality concerns when the interest of the federal government in that employee's participation outweighs concern over the questioning of the "integrity of the agency's programs and operations." See 5 C.F.R. § 2635.502(d). The factors that we can take into consideration are: (1) the nature of the relationship involved; (2) the effect that resolution of the matter will have upon the financial interest of the person affected in the relationship; (3) the nature and importance of the employee's role in the matter, including the extent to which the employee is called upon to exercise discretion in the matter: (4) the sensitivity of the matter; (5) the difficulty of reassigning the matter to another employee; and (6) adjustments that may be made in the employee's duties that would reduce or eliminate the likelihood that a reasonable person would question the employee's impartiality, In reviewing these factors, 1 have decided to allow you to participate fully in matters of general applicability, including rulemaking. including consideration of any comments that were made by ACC. In making this determination, I have taken the following factors into consideration: While at ACC, you served as the Senior Director of Regulatory Science Policy and worked extensively on risk assessment, science policy and rulemaking issues; As ACC's leading expert for ensuring sound implementation of risk assessment practices in the Frank R. Lautenberg Chemical Safety for the 21st Century Act, you have valuable expertise to share as the Agency considers how to implement this new statute; You have extensive prior expertise with the regulated industry's perspective and are already familiar with (and may well have authored) ACC comments now under consideration. Because your prior knowledge is inherently part of your expertise, it is impractical to excise that knowledge from how you carry out your Agency duties; Source: https://www.industrydocuments.ucsf.edu/docs/lpbn0226 While you still participate in an ACC defined contribution plan, neither you nor your former employer continues to make contributions. Pursuant to federal ethics regulations, this type of employee benefit plan does not present any financial conflict of interest. See 5 C.F.R. § 2640.201(c); Your unique expertise, knowledge and prior experience will ensure that the Agency is able to consider all perspectives, including that of the regulated industry's major trade association; Although your type of appointment at EPA is not a political one, you currently serve in the only non-career position in the Office of Chemical Safety and Pollution Prevention. As such, you have a unique role in advising political staff, including the Administrator, and need to be able to be able to consider as many perspectives as you can; and Participation in rulemaking matters is integral to your position, so the Agency has a strong and compelling interest in ensuring that you are able to advise the Administrator, the Acting Assistant Administrator and career staff to the maximum extent possible. Under the federal ethics regulations, you are permitted to participate in matters of general applicability (such as rulemaking) even if individual members of your former employer will be affected by that particular matter. Until now, you have recused yourself from participating personally and substantially in those comments to rulemaking that were offered by ACC. This impartiality determination confirms that you are permitted to participate in any discussions or consideration of comments submitted by ACC to rulemaking or other matters of general applicability. You may also attend meetings at which ACC is present or represented, but only if the following conditions are met: (a) the subject matter of the discussion is a particular matter of general applicability, (b) other interested non-federal entities are present besides only ACC, and (c) you are not the only Agency official at the meeting. This authorization will remain in effect for the remainder of your cooling off period. Affer April 21, 2018, you will no longer have a covered relationship with ACC under the impartiality standards and will no longer require this determination. I am attaching a recusal statement for you to sign and issue to your staff. If you have any questions regarding this determination, or if a situation arises in which you need advice or clarification, please contact Justina Fugh at [email protected] or (202) 564-1786. Attachment cc: Wendy Cleland-Hamnett, Acting Assistant Administrator Justina Fugh, Senior Counsel for Ethics Source: https://www.industrydocuments.ucsf.edu/docs//lpbn0226

Who is designated as agency ethics official and acting general counsel ?

lpbn0226

lpbn0226_p0, lpbn0226_p1, lpbn0226_p2

Kevin S. Minoli

* UNITED STATES ENVIRONMENTAL PROTECTION AGENCY Washington, D.C. 20460 JUN - 8 2017 OFFICE OF GENERAL COUNSEL MEMORANDUM SUBJECT: Participation in Specific Party Matters Involving Your Former Employer, the American Chemistry Council FROM: Kevin S. Minoli use Designated Agency Ethics Official and Acting General Counsel TO: Nancy Beck, Ph.D., DABT Deputy Assistant Administrator Office of Chemical Safety and Pollution Prevention Effective April 30, 2017, you joined the United States Environmental Protection Agency (EPA) in an Administratively Determined (AD) position as the Deputy Assistant Administrator for the Office of Chemical Safety and Pollution Prevention (OCSPP). In this position, you are responsible for advising the Acting Assistant Administrator in matters pertaining to chemical safety, pollution prevention, pesticides and toxie substances, including implementation of rulemaking under applicable federal statutes. Previous to your selection, you served as the Senior Director of Regulatory Science Policy at the American Chemistry Council (ACC), which represents companies that are directly regulated by EPA. You seek permission to participate in specific party matters involving your former employer. In providing my advice, 1 have taken into consideration the fact that, as an AD appointment, you are not required to sign the Trump ethics pledge because this type of appointment falls outside the definition of "appointee" set forth at Executive Order 13,770 at Section 2(b). 1 You do not have any financial conflict of interest with your former employer, so the ethics rules to be applied to you are set forth in the Standards of Ethical Conduct for Employees of the Executive Branch, 5 C.F.R. Part 2635, specifically Subpart E, "Impartiality in Performing Official Duty." Pursuant to 5 C.F.R. § 2635.502(b)(1)(iv), you have a "covered relationship" with ACC as your former employer. For one year from the time you resigned from ACC, absent an impartiality determination from me. you cannot participate in any specific party matter in which ACC is a party or represents a party if that matter is likely to have a direct and predictable financial effect upon the ACC or if the circumstances would cause a reasonable 3 See Office of Government Ethics advisories entitled "Guidance on Executive Order 13770," LA-17-03 (3/20/27) and Executive Order 13770," LA-17-02 (2/6/17), which apply the following OGE advisories from the last administration in full: "Who Must Sign the Ethics Piedge?" DO-09-010 (3/16/09). and "Signing the Ethics Pledge." DO-09-005 (2/10/09). Source: https://www.industrydocuments.ucsf.edu/docs/lpbn0226 person with knowledge of the relevant facts to question your impartiality. See 5 C.F.R. § 2635.502(a). It is important to note that the ethical restriction applies only to particular matters involving specific parties, not to particular matters of general applicability. Generally speaking, a "specific party" matter is a "proceeding affecting the legal rights of parties, or an isolatable transaction or related set of transactions between identified parties." See 5 C.F.R. § 2640.102(1). Rulemaking is not usually a *specific party" matter but rather a matter of general applicability, which involves "deliberation, decision, or action that is focused upon the interests of specific persons, or a discrete and identifiable class of persons." See 5 C.F.R. § 2640.103(a)(1). Therefore, under the ethics regulations, you may participate in rulemaking, even if that rulemaking may affect the members of your former employer. While you can ethically work on rulemaking in general, you have been advised -- and understand that you cannot participate in any meetings, discussions or decisions that relate to any individual ACC comment nor attend any meeting at which ACC is present. As provided by the ethics regulations, however, federal ethics officials can nonetheless permit employees to participate in matters that might raise impartiality concerns when the interest of the federal government in that employee's participation outweighs concern over the questioning of the "integrity of the agency's programs and operations." See 5 C.F.R. § 2635.502(d). The factors that we can take into consideration are: (1) the nature of the relationship involved; (2) the effect that resolution of the matter will have upon the financial interest of the person affected in the relationship; (3) the nature and importance of the employee's role in the matter, including the extent to which the employee is called upon to exercise discretion in the matter: (4) the sensitivity of the matter; (5) the difficulty of reassigning the matter to another employee; and (6) adjustments that may be made in the employee's duties that would reduce or eliminate the likelihood that a reasonable person would question the employee's impartiality, In reviewing these factors, 1 have decided to allow you to participate fully in matters of general applicability, including rulemaking. including consideration of any comments that were made by ACC. In making this determination, I have taken the following factors into consideration: While at ACC, you served as the Senior Director of Regulatory Science Policy and worked extensively on risk assessment, science policy and rulemaking issues; As ACC's leading expert for ensuring sound implementation of risk assessment practices in the Frank R. Lautenberg Chemical Safety for the 21st Century Act, you have valuable expertise to share as the Agency considers how to implement this new statute; You have extensive prior expertise with the regulated industry's perspective and are already familiar with (and may well have authored) ACC comments now under consideration. Because your prior knowledge is inherently part of your expertise, it is impractical to excise that knowledge from how you carry out your Agency duties; Source: https://www.industrydocuments.ucsf.edu/docs/lpbn0226 While you still participate in an ACC defined contribution plan, neither you nor your former employer continues to make contributions. Pursuant to federal ethics regulations, this type of employee benefit plan does not present any financial conflict of interest. See 5 C.F.R. § 2640.201(c); Your unique expertise, knowledge and prior experience will ensure that the Agency is able to consider all perspectives, including that of the regulated industry's major trade association; Although your type of appointment at EPA is not a political one, you currently serve in the only non-career position in the Office of Chemical Safety and Pollution Prevention. As such, you have a unique role in advising political staff, including the Administrator, and need to be able to be able to consider as many perspectives as you can; and Participation in rulemaking matters is integral to your position, so the Agency has a strong and compelling interest in ensuring that you are able to advise the Administrator, the Acting Assistant Administrator and career staff to the maximum extent possible. Under the federal ethics regulations, you are permitted to participate in matters of general applicability (such as rulemaking) even if individual members of your former employer will be affected by that particular matter. Until now, you have recused yourself from participating personally and substantially in those comments to rulemaking that were offered by ACC. This impartiality determination confirms that you are permitted to participate in any discussions or consideration of comments submitted by ACC to rulemaking or other matters of general applicability. You may also attend meetings at which ACC is present or represented, but only if the following conditions are met: (a) the subject matter of the discussion is a particular matter of general applicability, (b) other interested non-federal entities are present besides only ACC, and (c) you are not the only Agency official at the meeting. This authorization will remain in effect for the remainder of your cooling off period. Affer April 21, 2018, you will no longer have a covered relationship with ACC under the impartiality standards and will no longer require this determination. I am attaching a recusal statement for you to sign and issue to your staff. If you have any questions regarding this determination, or if a situation arises in which you need advice or clarification, please contact Justina Fugh at [email protected] or (202) 564-1786. Attachment cc: Wendy Cleland-Hamnett, Acting Assistant Administrator Justina Fugh, Senior Counsel for Ethics Source: https://www.industrydocuments.ucsf.edu/docs//lpbn0226

What does ACC supports?

kzbn0226

kzbn0226_p19, kzbn0226_p20, kzbn0226_p21

A CLEAR DEFINITION OF "REASONABLY AVAILABLE INFORMATION;", a clear definition of "reasonably available information"

variability, uncertainty, the degree of independent verification and peer review. In proposing this definition, ACC has drawn language directly from the 1996 SDWA amendments29 and from section 26(h) of the LCSA. EPA has already adopted the language from the SDWA amendments in the EPA Information Quality Guidelines. In addition, the concept 30 of evaluating data based on strengths and limitations is consistent with the definition provided in 31 the Senate Congressional Record for LCSA. To ensure a greater level transparency that forces EPA to "show its work," as was envisioned by the authors of the LCSA, 32 this definition covers not only what EPA must consider and evaluate, but also requires that important descriptions and documentation be including in EPA work products developed under Sections 4-6 of TSCA. ii. Weight of the Evidence (WoE). ACC suggests the following definition: Weight of the evidence means a systematic review method that uses a pre- established protocol to comprehensively, objectively, transparently, and consistently, identify and evaluate each stream of evidence, including strengths, limitations, and relevance of each study and to integrate evidence as necessary and appropriate based upon strengths, limitations, and relevance. ACC agrees that the term WoE has meant different things to different groups. In fact, different NAS studies contradict themselves regarding the use of this term and inconsistently define its meaning. As such, it is critically important that EPA clearly explain what this term means to the Agency. This term cannot and should not be avoided or discounted as Section 26(i) of the LCSA codifies the requirement for EPA to use a WoE approach. As such, a clear and transparent definition is critical. ACC is recommending the use of the definition that is in the June 7, 2016 Senate Congressional Record. This is the definition we have provided above. This definition is also consistent with 33 the June 2015 House Report Language. 34 While other definitions exist, using the definition associated with LCSA makes the most sense and is a straightforward approach that is clearly linked to the intent of Congress. Without a clear definition, WoE will continue to mean different things to different experts and stakeholders. An example illustrates that EPA very recently has not interpreted WoE in the same way Congress now intends. In the draft risk assessment of 1-bromopropane (released prior to enactment of LCSA), EPA does not provide information regarding the quality of the individual 29 Id. 30 See generally, EPA Information Quality Guidelines. 31 Senate Congressional Record, June 7, 2016 at S3518. 32 Id. at S3522. 33 Id at S3518. 34 See House Report, at 33, available at 15/Page Source: https://www.industrydocuments.ucsf.edu/docs/kzbn0226 studies. Although the assessment identified some quality considerations, EPA did not provide 35,36 any information regarding its own findings from its quality review of the individual studies. 37 Additionally, no information was provided to describe how quality, relevance, and reliability considerations were applied and what constitutes a study of "high quality" or "good quality.' EPA simply chose the value that provided the lowest point of departure and thus would be most health protective. While EPA staff stated that they followed a WoE approach, 38 picking the lowest point of departure, without an explicit consideration of study quality, is not consistent with a WoE approach. Until there is one clear definition, confusion such as this will likely continue and this confusion will stifle the scientific dialogue. iii. Sufficiency of Information. ACC suggests the following definition: Sufficiency of information means that, taking into account the importance of the determination, the Agency has appropriately relied on the best available science, considering the weight of the scientific evidence to make a reasoned and transparent fit-for-purpose determination. This definition is important as EPA uses this term repeatedly in the preamble of the proposed rule to describe scientific information. We have provided a definition that ties this information directly to the best available science and weight of the evidence standards required in Section 26 of the LCSA. If no definition is provided, stakeholders are left guessing as to what standards will define sufficient information. In the preamble of the proposed rule, EPA uses related terms including "scientifically valid information" and "sufficient quality.' These terms must also be defined. ACC suggests the following: Scientifically valid information means information that the agency has considered the quality, reliability, and relevance of the information for the decision being made. Consistent with the Agency Assessment Factors Guidance (2003) evaluation of information will include the consideration of the soundness, applicability and utility, clarity and completeness, uncertainty and variability and evaluation and review of the information. 35 See Comments of the American Chemistry Council on the TSCA Work Plan Chemical Draft Risk Assessment of 1-Bromopropane, Docket No. EPA-HQ-OPPT-2015-0084, May 9, 2016. 36 See Chemical Safety Advisory Committee Minutes No. 2016-02, at 41, available at the Agency indicates that the literature was thoroughly reviewed for robustness, adequacy, etc., the Committee found that it is not clear what exact methodology was used to systematically rate, rank, and select studies to inform sections of the risk assessment. For example, was a quantitative ranking system developed for study quality?") 37 See TSCA Work Plan Chemical Risk Assessment Peer Review Draft, at Appendix M, available at and appendices final.pdf. 38 See Chemical Safety Advisory Committee Meeting Transcript, at 130, available at ittps://www.regulations.gov/documentD=BPA-HQ-OPPT-2015-0805-0027. 16/Page Source: https://www.industrydocuments.ucsf.edu/docs/kzbn0226 Sufficient quality means that the Agency has relied on scientifically valid information to make the determination. These definitions are consistent with existing Agency guidance. However, to improve transparency and consistency, it is important that EPA clearly define these terms in the final rulemaking. iv. Unreasonable Risk. ACC agrees with EPA that a single definition of unreasonable risk is not workable due to the variety of factors that are necessary to consider when making an unreasonable risk finding. However, the risk evaluation rule should list the considerations that must be taken into account in making that finding. More importantly, EPA should commit to describing and transparently presenting how each of these considerations impacted the unreasonable risk finding. The descriptions that support the unreasonable risk finding should be presented in the draft and final risk evaluation documents. ACC suggests the following description be included in the preamble to final rule: Unreasonable risk means that the Administrator has considered relevant factors, including the effects of the chemical substance on health and the magnitude of human exposure to such substance under the conditions of use; the effects of the chemical substance on the environment; and the magnitude of environmental exposure to such substance under the conditions of use. Factors considered to reach this risk-based determination may include: characterization of cancer and non-cancer risks (including margins of exposure for non-cancer risks and mode of action analyses for cancer risks), characterization of environmental risk, the population exposed (including any susceptible populations), the severity of hazard (the nature of the hazard), the irreversibility of hazard, and uncertainties associated with the analyses and data. This description is generally consistent with the considerations EPA has provided in the proposed rule, and adds a consideration to ensure that environmental risk findings are also considered. Notably, however, EPA inappropriately includes cumulative exposure in its list of considerations. This should be removed. LCSA does not require the consideration of 39 cumulative exposure in the risk evaluation process. Further, there is no generally accepted approach to inform the scientific methods, inputs and tools to evaluate cumulative risk. While EPA and other agencies continue to work on guidance in this area, scientifically robust draft frameworks for the evaluation of cumulative exposure risks are non-existent. V. Reasonably Available Information. ACC supports a clear definition of "reasonably available information;" however, we offer specific suggestions (shown in strikethrough and underline) to improve the definition EPA has provided: 39 82 Fed. Reg. at 7566. 17/Page Source: https://www.industrydocuments.ucsf.edu/docs/kzbn0226

what does OCSPP stands for?

lpbn0226

lpbn0226_p0, lpbn0226_p1, lpbn0226_p2

OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION, office of chemical safety and pollution prevention.

* UNITED STATES ENVIRONMENTAL PROTECTION AGENCY Washington, D.C. 20460 JUN - 8 2017 OFFICE OF GENERAL COUNSEL MEMORANDUM SUBJECT: Participation in Specific Party Matters Involving Your Former Employer, the American Chemistry Council FROM: Kevin S. Minoli use Designated Agency Ethics Official and Acting General Counsel TO: Nancy Beck, Ph.D., DABT Deputy Assistant Administrator Office of Chemical Safety and Pollution Prevention Effective April 30, 2017, you joined the United States Environmental Protection Agency (EPA) in an Administratively Determined (AD) position as the Deputy Assistant Administrator for the Office of Chemical Safety and Pollution Prevention (OCSPP). In this position, you are responsible for advising the Acting Assistant Administrator in matters pertaining to chemical safety, pollution prevention, pesticides and toxie substances, including implementation of rulemaking under applicable federal statutes. Previous to your selection, you served as the Senior Director of Regulatory Science Policy at the American Chemistry Council (ACC), which represents companies that are directly regulated by EPA. You seek permission to participate in specific party matters involving your former employer. In providing my advice, 1 have taken into consideration the fact that, as an AD appointment, you are not required to sign the Trump ethics pledge because this type of appointment falls outside the definition of "appointee" set forth at Executive Order 13,770 at Section 2(b). 1 You do not have any financial conflict of interest with your former employer, so the ethics rules to be applied to you are set forth in the Standards of Ethical Conduct for Employees of the Executive Branch, 5 C.F.R. Part 2635, specifically Subpart E, "Impartiality in Performing Official Duty." Pursuant to 5 C.F.R. § 2635.502(b)(1)(iv), you have a "covered relationship" with ACC as your former employer. For one year from the time you resigned from ACC, absent an impartiality determination from me. you cannot participate in any specific party matter in which ACC is a party or represents a party if that matter is likely to have a direct and predictable financial effect upon the ACC or if the circumstances would cause a reasonable 3 See Office of Government Ethics advisories entitled "Guidance on Executive Order 13770," LA-17-03 (3/20/27) and Executive Order 13770," LA-17-02 (2/6/17), which apply the following OGE advisories from the last administration in full: "Who Must Sign the Ethics Piedge?" DO-09-010 (3/16/09). and "Signing the Ethics Pledge." DO-09-005 (2/10/09). Source: https://www.industrydocuments.ucsf.edu/docs/lpbn0226 person with knowledge of the relevant facts to question your impartiality. See 5 C.F.R. § 2635.502(a). It is important to note that the ethical restriction applies only to particular matters involving specific parties, not to particular matters of general applicability. Generally speaking, a "specific party" matter is a "proceeding affecting the legal rights of parties, or an isolatable transaction or related set of transactions between identified parties." See 5 C.F.R. § 2640.102(1). Rulemaking is not usually a *specific party" matter but rather a matter of general applicability, which involves "deliberation, decision, or action that is focused upon the interests of specific persons, or a discrete and identifiable class of persons." See 5 C.F.R. § 2640.103(a)(1). Therefore, under the ethics regulations, you may participate in rulemaking, even if that rulemaking may affect the members of your former employer. While you can ethically work on rulemaking in general, you have been advised -- and understand that you cannot participate in any meetings, discussions or decisions that relate to any individual ACC comment nor attend any meeting at which ACC is present. As provided by the ethics regulations, however, federal ethics officials can nonetheless permit employees to participate in matters that might raise impartiality concerns when the interest of the federal government in that employee's participation outweighs concern over the questioning of the "integrity of the agency's programs and operations." See 5 C.F.R. § 2635.502(d). The factors that we can take into consideration are: (1) the nature of the relationship involved; (2) the effect that resolution of the matter will have upon the financial interest of the person affected in the relationship; (3) the nature and importance of the employee's role in the matter, including the extent to which the employee is called upon to exercise discretion in the matter: (4) the sensitivity of the matter; (5) the difficulty of reassigning the matter to another employee; and (6) adjustments that may be made in the employee's duties that would reduce or eliminate the likelihood that a reasonable person would question the employee's impartiality, In reviewing these factors, 1 have decided to allow you to participate fully in matters of general applicability, including rulemaking. including consideration of any comments that were made by ACC. In making this determination, I have taken the following factors into consideration: While at ACC, you served as the Senior Director of Regulatory Science Policy and worked extensively on risk assessment, science policy and rulemaking issues; As ACC's leading expert for ensuring sound implementation of risk assessment practices in the Frank R. Lautenberg Chemical Safety for the 21st Century Act, you have valuable expertise to share as the Agency considers how to implement this new statute; You have extensive prior expertise with the regulated industry's perspective and are already familiar with (and may well have authored) ACC comments now under consideration. Because your prior knowledge is inherently part of your expertise, it is impractical to excise that knowledge from how you carry out your Agency duties; Source: https://www.industrydocuments.ucsf.edu/docs/lpbn0226 While you still participate in an ACC defined contribution plan, neither you nor your former employer continues to make contributions. Pursuant to federal ethics regulations, this type of employee benefit plan does not present any financial conflict of interest. See 5 C.F.R. § 2640.201(c); Your unique expertise, knowledge and prior experience will ensure that the Agency is able to consider all perspectives, including that of the regulated industry's major trade association; Although your type of appointment at EPA is not a political one, you currently serve in the only non-career position in the Office of Chemical Safety and Pollution Prevention. As such, you have a unique role in advising political staff, including the Administrator, and need to be able to be able to consider as many perspectives as you can; and Participation in rulemaking matters is integral to your position, so the Agency has a strong and compelling interest in ensuring that you are able to advise the Administrator, the Acting Assistant Administrator and career staff to the maximum extent possible. Under the federal ethics regulations, you are permitted to participate in matters of general applicability (such as rulemaking) even if individual members of your former employer will be affected by that particular matter. Until now, you have recused yourself from participating personally and substantially in those comments to rulemaking that were offered by ACC. This impartiality determination confirms that you are permitted to participate in any discussions or consideration of comments submitted by ACC to rulemaking or other matters of general applicability. You may also attend meetings at which ACC is present or represented, but only if the following conditions are met: (a) the subject matter of the discussion is a particular matter of general applicability, (b) other interested non-federal entities are present besides only ACC, and (c) you are not the only Agency official at the meeting. This authorization will remain in effect for the remainder of your cooling off period. Affer April 21, 2018, you will no longer have a covered relationship with ACC under the impartiality standards and will no longer require this determination. I am attaching a recusal statement for you to sign and issue to your staff. If you have any questions regarding this determination, or if a situation arises in which you need advice or clarification, please contact Justina Fugh at [email protected] or (202) 564-1786. Attachment cc: Wendy Cleland-Hamnett, Acting Assistant Administrator Justina Fugh, Senior Counsel for Ethics Source: https://www.industrydocuments.ucsf.edu/docs//lpbn0226

What does CEQ stands for?

mlcn0226

mlcn0226_p0, mlcn0226_p1

Council on Environmental Quality, COUNCIL ON ENVIRONMENTAL QUALITY

SA comes - MIRS BASORA 3 Minited States State . & SKMALA COMMITTEE ON ENVIRONMENT AND PUBLIC WORKS DO SS. MINDRITY August 18, 2017 The Honorable Gene L. Dodaro Comptrollen General of the United States U.S. Government Accountability Office 441 G Street, NW Washington, DC 20548 Dear Mr. Dodaro: The Environmental Protection Agency (EPA) and Council on Environmental Quality (CEQ) use various authorities to hire political appointees. It has come to our attention that the ethics requirements for political appointees vary by the authority under which the appointment was made. Some of the appointees are in high-level positions, managing staff and making consequential decisions, yet they were hired in a manner that exempts them from compliance with Executive Order 13,770: Ethics Commitments by Executive Branch Appointees (otherwise known as the Trump Ethics Pledge). We are additionally concerned that the authorities are being abused and that non-confirmed political appointees may not be complying with the ethics requirements that do apply to them in a timely or complete manner. For example, EPA is authorized under the Safe Drinking Water Act (SDWA, at 42 U.S.C. § 300j-10) to appoint "not more than thirty scientific, engineering, professional, legal, and administrative positions within the Environmental Protection Agency without regard to the civil service laws." The Office of Government Ethics (OGE) has advised that individuals employed pursuant to this authority are exempted from certain other Executive Branch requirements, including the Trump Ethics Pledge, although they remain subject to other ethics requirements such as 5 CFR Part 2635, Subpart E entitled "Impartiality in Performing Official Duties." In contrast, other political appointees are often hired as Schedule C or non-career Senior Executive Service employees, both of which are subject to Executive Order 13,770 and other ethics requirements such as 5 CFR Part 2635, Subpart E. EPA has utilized its SDWA authority to hire a number of non-Senate-confirmed political appointees, some of whom are serving in supervisory positions and in roles that raise ethical questions. Various entities, including OGE, Office of Personnel Management, and the Designated Agency Ethics Officials, play differing roles in implementing and overseeing compliance with ethics requirements depending on the authority. When we have made inquiries directed to these entities regarding these matters, we have often been told the specific entity does not handle the particular aspect we asked about and get unclear answers about which entity does. Our written requests to EPA for specific information regarding political appointees have thus far gone almost entirely unanswered. We write to request that GAO examine the authorities, policies, practices, entities involved, and compliance with applicable ethics requirements that EPA and CEQ have followed in hiring non-confirmed political appointees. Specifically, we request that GAO undertake a review that addresses the following: es - Source: https://www.industrydocuments.ucsf.edu/docs/mlcn0226 Pg.2, Hon. Gene Dodaro August 18, 2017 All authorities that can be used to hire political appointees at EPA and CEQ, including the policies and procedures, any background and position requirements and limitations, ethics requirements (including but not limited to compliance with the Trump Ethics Pledge), the agency charged with implementation and oversight of each requirement, and which, if any, civil services laws are permitted to be disregarded. Historical and current use of the authorities to employ non-Senate-confirmed political employees, including the types of roles such employees have been hired to perform, the length of service, whether the roles and responsibilities are consistent with the authority and its use during the Obama Administration, and any abuse. of the hiring authorities. This should include a review of the initial authority used to hire an appointee. For non-Senate-confirmed appointees who are required to comply with the Trump Ethics Pledge, please note at what point following their date of hire or date on which they subsequently became subject to the Pledge because their employment status changed; At what point did they agree to comply, receive a written ethics determination regarding any recusals or other measures they needed to take in order to assure compliance; and, if applicable, at what point a waiver was granted. Whether non-Senate-confirmed political appointees who were not subject to Executive Order 13,770 on the date of hire underwent a process to assure their compliance with other applicable ethics regulations. Please detail at what point such a process was completed; at what point they received a written ethical determination regarding any recusals or other measures they needed to take in order to assure compliance; and, if applicable, at what point was a public interest or other determination made regarding their continued work on particular subject matter or participation in certain meetings. For any lag time between the date of hire or transition into a position with different ethics requirements and the date that written ethics analysis or recusal agreements are signed, the extent to which retrospective reviews were conducted to ensure appointees did not violate ethics Executive Order 13,770 or other requirements. Further, determine whether non-confirmed political appointees have been found to have worked on subject matter, communicated with outside groups, or participated in certain meetings that were later determined by the Designated Agency Ethics Official or any other entity to require recusals or other measures. Thank you very much for your consideration of this important matter. If you or members of your staff have any questions or concerns with the contents of this letter, please ask them to contact Michal Freedhoff on the Environment and Public Works Committee staff at 202-224- 8832 and Emily Enderle on Senator Whitehouse's staff at 202-224-2921. Sincerely, Tom Carper Sheldon Whitehouse U.S. Senator U.S. Senator Source: https://www.industrydocuments.ucsf.edu/docs/mlcn0226

what is the subject for this 'memorandum' ?

lpbn0226

lpbn0226_p0, lpbn0226_p1, lpbn0226_p2

PARTICIPATION IN SPECIFIC PARTY MATTERS INVOLVING YOUR FORMER EMPLOYER, THE AMERICAN CHEMISTRY COUNCIL, participation in specific party matters involving your former employer, the american chemistry council

* UNITED STATES ENVIRONMENTAL PROTECTION AGENCY Washington, D.C. 20460 JUN - 8 2017 OFFICE OF GENERAL COUNSEL MEMORANDUM SUBJECT: Participation in Specific Party Matters Involving Your Former Employer, the American Chemistry Council FROM: Kevin S. Minoli use Designated Agency Ethics Official and Acting General Counsel TO: Nancy Beck, Ph.D., DABT Deputy Assistant Administrator Office of Chemical Safety and Pollution Prevention Effective April 30, 2017, you joined the United States Environmental Protection Agency (EPA) in an Administratively Determined (AD) position as the Deputy Assistant Administrator for the Office of Chemical Safety and Pollution Prevention (OCSPP). In this position, you are responsible for advising the Acting Assistant Administrator in matters pertaining to chemical safety, pollution prevention, pesticides and toxie substances, including implementation of rulemaking under applicable federal statutes. Previous to your selection, you served as the Senior Director of Regulatory Science Policy at the American Chemistry Council (ACC), which represents companies that are directly regulated by EPA. You seek permission to participate in specific party matters involving your former employer. In providing my advice, 1 have taken into consideration the fact that, as an AD appointment, you are not required to sign the Trump ethics pledge because this type of appointment falls outside the definition of "appointee" set forth at Executive Order 13,770 at Section 2(b). 1 You do not have any financial conflict of interest with your former employer, so the ethics rules to be applied to you are set forth in the Standards of Ethical Conduct for Employees of the Executive Branch, 5 C.F.R. Part 2635, specifically Subpart E, "Impartiality in Performing Official Duty." Pursuant to 5 C.F.R. § 2635.502(b)(1)(iv), you have a "covered relationship" with ACC as your former employer. For one year from the time you resigned from ACC, absent an impartiality determination from me. you cannot participate in any specific party matter in which ACC is a party or represents a party if that matter is likely to have a direct and predictable financial effect upon the ACC or if the circumstances would cause a reasonable 3 See Office of Government Ethics advisories entitled "Guidance on Executive Order 13770," LA-17-03 (3/20/27) and Executive Order 13770," LA-17-02 (2/6/17), which apply the following OGE advisories from the last administration in full: "Who Must Sign the Ethics Piedge?" DO-09-010 (3/16/09). and "Signing the Ethics Pledge." DO-09-005 (2/10/09). Source: https://www.industrydocuments.ucsf.edu/docs/lpbn0226 person with knowledge of the relevant facts to question your impartiality. See 5 C.F.R. § 2635.502(a). It is important to note that the ethical restriction applies only to particular matters involving specific parties, not to particular matters of general applicability. Generally speaking, a "specific party" matter is a "proceeding affecting the legal rights of parties, or an isolatable transaction or related set of transactions between identified parties." See 5 C.F.R. § 2640.102(1). Rulemaking is not usually a *specific party" matter but rather a matter of general applicability, which involves "deliberation, decision, or action that is focused upon the interests of specific persons, or a discrete and identifiable class of persons." See 5 C.F.R. § 2640.103(a)(1). Therefore, under the ethics regulations, you may participate in rulemaking, even if that rulemaking may affect the members of your former employer. While you can ethically work on rulemaking in general, you have been advised -- and understand that you cannot participate in any meetings, discussions or decisions that relate to any individual ACC comment nor attend any meeting at which ACC is present. As provided by the ethics regulations, however, federal ethics officials can nonetheless permit employees to participate in matters that might raise impartiality concerns when the interest of the federal government in that employee's participation outweighs concern over the questioning of the "integrity of the agency's programs and operations." See 5 C.F.R. § 2635.502(d). The factors that we can take into consideration are: (1) the nature of the relationship involved; (2) the effect that resolution of the matter will have upon the financial interest of the person affected in the relationship; (3) the nature and importance of the employee's role in the matter, including the extent to which the employee is called upon to exercise discretion in the matter: (4) the sensitivity of the matter; (5) the difficulty of reassigning the matter to another employee; and (6) adjustments that may be made in the employee's duties that would reduce or eliminate the likelihood that a reasonable person would question the employee's impartiality, In reviewing these factors, 1 have decided to allow you to participate fully in matters of general applicability, including rulemaking. including consideration of any comments that were made by ACC. In making this determination, I have taken the following factors into consideration: While at ACC, you served as the Senior Director of Regulatory Science Policy and worked extensively on risk assessment, science policy and rulemaking issues; As ACC's leading expert for ensuring sound implementation of risk assessment practices in the Frank R. Lautenberg Chemical Safety for the 21st Century Act, you have valuable expertise to share as the Agency considers how to implement this new statute; You have extensive prior expertise with the regulated industry's perspective and are already familiar with (and may well have authored) ACC comments now under consideration. Because your prior knowledge is inherently part of your expertise, it is impractical to excise that knowledge from how you carry out your Agency duties; Source: https://www.industrydocuments.ucsf.edu/docs/lpbn0226 While you still participate in an ACC defined contribution plan, neither you nor your former employer continues to make contributions. Pursuant to federal ethics regulations, this type of employee benefit plan does not present any financial conflict of interest. See 5 C.F.R. § 2640.201(c); Your unique expertise, knowledge and prior experience will ensure that the Agency is able to consider all perspectives, including that of the regulated industry's major trade association; Although your type of appointment at EPA is not a political one, you currently serve in the only non-career position in the Office of Chemical Safety and Pollution Prevention. As such, you have a unique role in advising political staff, including the Administrator, and need to be able to be able to consider as many perspectives as you can; and Participation in rulemaking matters is integral to your position, so the Agency has a strong and compelling interest in ensuring that you are able to advise the Administrator, the Acting Assistant Administrator and career staff to the maximum extent possible. Under the federal ethics regulations, you are permitted to participate in matters of general applicability (such as rulemaking) even if individual members of your former employer will be affected by that particular matter. Until now, you have recused yourself from participating personally and substantially in those comments to rulemaking that were offered by ACC. This impartiality determination confirms that you are permitted to participate in any discussions or consideration of comments submitted by ACC to rulemaking or other matters of general applicability. You may also attend meetings at which ACC is present or represented, but only if the following conditions are met: (a) the subject matter of the discussion is a particular matter of general applicability, (b) other interested non-federal entities are present besides only ACC, and (c) you are not the only Agency official at the meeting. This authorization will remain in effect for the remainder of your cooling off period. Affer April 21, 2018, you will no longer have a covered relationship with ACC under the impartiality standards and will no longer require this determination. I am attaching a recusal statement for you to sign and issue to your staff. If you have any questions regarding this determination, or if a situation arises in which you need advice or clarification, please contact Justina Fugh at [email protected] or (202) 564-1786. Attachment cc: Wendy Cleland-Hamnett, Acting Assistant Administrator Justina Fugh, Senior Counsel for Ethics Source: https://www.industrydocuments.ucsf.edu/docs//lpbn0226

What is the issued date of the letter?

mlcn0226

mlcn0226_p0, mlcn0226_p1

AUGUST 18, 2017, August 18, 2017

SA comes - MIRS BASORA 3 Minited States State . & SKMALA COMMITTEE ON ENVIRONMENT AND PUBLIC WORKS DO SS. MINDRITY August 18, 2017 The Honorable Gene L. Dodaro Comptrollen General of the United States U.S. Government Accountability Office 441 G Street, NW Washington, DC 20548 Dear Mr. Dodaro: The Environmental Protection Agency (EPA) and Council on Environmental Quality (CEQ) use various authorities to hire political appointees. It has come to our attention that the ethics requirements for political appointees vary by the authority under which the appointment was made. Some of the appointees are in high-level positions, managing staff and making consequential decisions, yet they were hired in a manner that exempts them from compliance with Executive Order 13,770: Ethics Commitments by Executive Branch Appointees (otherwise known as the Trump Ethics Pledge). We are additionally concerned that the authorities are being abused and that non-confirmed political appointees may not be complying with the ethics requirements that do apply to them in a timely or complete manner. For example, EPA is authorized under the Safe Drinking Water Act (SDWA, at 42 U.S.C. § 300j-10) to appoint "not more than thirty scientific, engineering, professional, legal, and administrative positions within the Environmental Protection Agency without regard to the civil service laws." The Office of Government Ethics (OGE) has advised that individuals employed pursuant to this authority are exempted from certain other Executive Branch requirements, including the Trump Ethics Pledge, although they remain subject to other ethics requirements such as 5 CFR Part 2635, Subpart E entitled "Impartiality in Performing Official Duties." In contrast, other political appointees are often hired as Schedule C or non-career Senior Executive Service employees, both of which are subject to Executive Order 13,770 and other ethics requirements such as 5 CFR Part 2635, Subpart E. EPA has utilized its SDWA authority to hire a number of non-Senate-confirmed political appointees, some of whom are serving in supervisory positions and in roles that raise ethical questions. Various entities, including OGE, Office of Personnel Management, and the Designated Agency Ethics Officials, play differing roles in implementing and overseeing compliance with ethics requirements depending on the authority. When we have made inquiries directed to these entities regarding these matters, we have often been told the specific entity does not handle the particular aspect we asked about and get unclear answers about which entity does. Our written requests to EPA for specific information regarding political appointees have thus far gone almost entirely unanswered. We write to request that GAO examine the authorities, policies, practices, entities involved, and compliance with applicable ethics requirements that EPA and CEQ have followed in hiring non-confirmed political appointees. Specifically, we request that GAO undertake a review that addresses the following: es - Source: https://www.industrydocuments.ucsf.edu/docs/mlcn0226 Pg.2, Hon. Gene Dodaro August 18, 2017 All authorities that can be used to hire political appointees at EPA and CEQ, including the policies and procedures, any background and position requirements and limitations, ethics requirements (including but not limited to compliance with the Trump Ethics Pledge), the agency charged with implementation and oversight of each requirement, and which, if any, civil services laws are permitted to be disregarded. Historical and current use of the authorities to employ non-Senate-confirmed political employees, including the types of roles such employees have been hired to perform, the length of service, whether the roles and responsibilities are consistent with the authority and its use during the Obama Administration, and any abuse. of the hiring authorities. This should include a review of the initial authority used to hire an appointee. For non-Senate-confirmed appointees who are required to comply with the Trump Ethics Pledge, please note at what point following their date of hire or date on which they subsequently became subject to the Pledge because their employment status changed; At what point did they agree to comply, receive a written ethics determination regarding any recusals or other measures they needed to take in order to assure compliance; and, if applicable, at what point a waiver was granted. Whether non-Senate-confirmed political appointees who were not subject to Executive Order 13,770 on the date of hire underwent a process to assure their compliance with other applicable ethics regulations. Please detail at what point such a process was completed; at what point they received a written ethical determination regarding any recusals or other measures they needed to take in order to assure compliance; and, if applicable, at what point was a public interest or other determination made regarding their continued work on particular subject matter or participation in certain meetings. For any lag time between the date of hire or transition into a position with different ethics requirements and the date that written ethics analysis or recusal agreements are signed, the extent to which retrospective reviews were conducted to ensure appointees did not violate ethics Executive Order 13,770 or other requirements. Further, determine whether non-confirmed political appointees have been found to have worked on subject matter, communicated with outside groups, or participated in certain meetings that were later determined by the Designated Agency Ethics Official or any other entity to require recusals or other measures. Thank you very much for your consideration of this important matter. If you or members of your staff have any questions or concerns with the contents of this letter, please ask them to contact Michal Freedhoff on the Environment and Public Works Committee staff at 202-224- 8832 and Emily Enderle on Senator Whitehouse's staff at 202-224-2921. Sincerely, Tom Carper Sheldon Whitehouse U.S. Senator U.S. Senator Source: https://www.industrydocuments.ucsf.edu/docs/mlcn0226

Which authority is utilized by EPA to hire a number of non-Senate-confirmed political appointees?

mlcn0226

mlcn0226_p0, mlcn0226_p1

SDWA, SDWA authority

SA comes - MIRS BASORA 3 Minited States State . & SKMALA COMMITTEE ON ENVIRONMENT AND PUBLIC WORKS DO SS. MINDRITY August 18, 2017 The Honorable Gene L. Dodaro Comptrollen General of the United States U.S. Government Accountability Office 441 G Street, NW Washington, DC 20548 Dear Mr. Dodaro: The Environmental Protection Agency (EPA) and Council on Environmental Quality (CEQ) use various authorities to hire political appointees. It has come to our attention that the ethics requirements for political appointees vary by the authority under which the appointment was made. Some of the appointees are in high-level positions, managing staff and making consequential decisions, yet they were hired in a manner that exempts them from compliance with Executive Order 13,770: Ethics Commitments by Executive Branch Appointees (otherwise known as the Trump Ethics Pledge). We are additionally concerned that the authorities are being abused and that non-confirmed political appointees may not be complying with the ethics requirements that do apply to them in a timely or complete manner. For example, EPA is authorized under the Safe Drinking Water Act (SDWA, at 42 U.S.C. § 300j-10) to appoint "not more than thirty scientific, engineering, professional, legal, and administrative positions within the Environmental Protection Agency without regard to the civil service laws." The Office of Government Ethics (OGE) has advised that individuals employed pursuant to this authority are exempted from certain other Executive Branch requirements, including the Trump Ethics Pledge, although they remain subject to other ethics requirements such as 5 CFR Part 2635, Subpart E entitled "Impartiality in Performing Official Duties." In contrast, other political appointees are often hired as Schedule C or non-career Senior Executive Service employees, both of which are subject to Executive Order 13,770 and other ethics requirements such as 5 CFR Part 2635, Subpart E. EPA has utilized its SDWA authority to hire a number of non-Senate-confirmed political appointees, some of whom are serving in supervisory positions and in roles that raise ethical questions. Various entities, including OGE, Office of Personnel Management, and the Designated Agency Ethics Officials, play differing roles in implementing and overseeing compliance with ethics requirements depending on the authority. When we have made inquiries directed to these entities regarding these matters, we have often been told the specific entity does not handle the particular aspect we asked about and get unclear answers about which entity does. Our written requests to EPA for specific information regarding political appointees have thus far gone almost entirely unanswered. We write to request that GAO examine the authorities, policies, practices, entities involved, and compliance with applicable ethics requirements that EPA and CEQ have followed in hiring non-confirmed political appointees. Specifically, we request that GAO undertake a review that addresses the following: es - Source: https://www.industrydocuments.ucsf.edu/docs/mlcn0226 Pg.2, Hon. Gene Dodaro August 18, 2017 All authorities that can be used to hire political appointees at EPA and CEQ, including the policies and procedures, any background and position requirements and limitations, ethics requirements (including but not limited to compliance with the Trump Ethics Pledge), the agency charged with implementation and oversight of each requirement, and which, if any, civil services laws are permitted to be disregarded. Historical and current use of the authorities to employ non-Senate-confirmed political employees, including the types of roles such employees have been hired to perform, the length of service, whether the roles and responsibilities are consistent with the authority and its use during the Obama Administration, and any abuse. of the hiring authorities. This should include a review of the initial authority used to hire an appointee. For non-Senate-confirmed appointees who are required to comply with the Trump Ethics Pledge, please note at what point following their date of hire or date on which they subsequently became subject to the Pledge because their employment status changed; At what point did they agree to comply, receive a written ethics determination regarding any recusals or other measures they needed to take in order to assure compliance; and, if applicable, at what point a waiver was granted. Whether non-Senate-confirmed political appointees who were not subject to Executive Order 13,770 on the date of hire underwent a process to assure their compliance with other applicable ethics regulations. Please detail at what point such a process was completed; at what point they received a written ethical determination regarding any recusals or other measures they needed to take in order to assure compliance; and, if applicable, at what point was a public interest or other determination made regarding their continued work on particular subject matter or participation in certain meetings. For any lag time between the date of hire or transition into a position with different ethics requirements and the date that written ethics analysis or recusal agreements are signed, the extent to which retrospective reviews were conducted to ensure appointees did not violate ethics Executive Order 13,770 or other requirements. Further, determine whether non-confirmed political appointees have been found to have worked on subject matter, communicated with outside groups, or participated in certain meetings that were later determined by the Designated Agency Ethics Official or any other entity to require recusals or other measures. Thank you very much for your consideration of this important matter. If you or members of your staff have any questions or concerns with the contents of this letter, please ask them to contact Michal Freedhoff on the Environment and Public Works Committee staff at 202-224- 8832 and Emily Enderle on Senator Whitehouse's staff at 202-224-2921. Sincerely, Tom Carper Sheldon Whitehouse U.S. Senator U.S. Senator Source: https://www.industrydocuments.ucsf.edu/docs/mlcn0226

Who is the addressee of this letter?

mlcn0226

mlcn0226_p0, mlcn0226_p1

THE HONORABLE GENE L. DODARO, MR. DODARO, Mr. Dodaro

SA comes - MIRS BASORA 3 Minited States State . & SKMALA COMMITTEE ON ENVIRONMENT AND PUBLIC WORKS DO SS. MINDRITY August 18, 2017 The Honorable Gene L. Dodaro Comptrollen General of the United States U.S. Government Accountability Office 441 G Street, NW Washington, DC 20548 Dear Mr. Dodaro: The Environmental Protection Agency (EPA) and Council on Environmental Quality (CEQ) use various authorities to hire political appointees. It has come to our attention that the ethics requirements for political appointees vary by the authority under which the appointment was made. Some of the appointees are in high-level positions, managing staff and making consequential decisions, yet they were hired in a manner that exempts them from compliance with Executive Order 13,770: Ethics Commitments by Executive Branch Appointees (otherwise known as the Trump Ethics Pledge). We are additionally concerned that the authorities are being abused and that non-confirmed political appointees may not be complying with the ethics requirements that do apply to them in a timely or complete manner. For example, EPA is authorized under the Safe Drinking Water Act (SDWA, at 42 U.S.C. § 300j-10) to appoint "not more than thirty scientific, engineering, professional, legal, and administrative positions within the Environmental Protection Agency without regard to the civil service laws." The Office of Government Ethics (OGE) has advised that individuals employed pursuant to this authority are exempted from certain other Executive Branch requirements, including the Trump Ethics Pledge, although they remain subject to other ethics requirements such as 5 CFR Part 2635, Subpart E entitled "Impartiality in Performing Official Duties." In contrast, other political appointees are often hired as Schedule C or non-career Senior Executive Service employees, both of which are subject to Executive Order 13,770 and other ethics requirements such as 5 CFR Part 2635, Subpart E. EPA has utilized its SDWA authority to hire a number of non-Senate-confirmed political appointees, some of whom are serving in supervisory positions and in roles that raise ethical questions. Various entities, including OGE, Office of Personnel Management, and the Designated Agency Ethics Officials, play differing roles in implementing and overseeing compliance with ethics requirements depending on the authority. When we have made inquiries directed to these entities regarding these matters, we have often been told the specific entity does not handle the particular aspect we asked about and get unclear answers about which entity does. Our written requests to EPA for specific information regarding political appointees have thus far gone almost entirely unanswered. We write to request that GAO examine the authorities, policies, practices, entities involved, and compliance with applicable ethics requirements that EPA and CEQ have followed in hiring non-confirmed political appointees. Specifically, we request that GAO undertake a review that addresses the following: es - Source: https://www.industrydocuments.ucsf.edu/docs/mlcn0226 Pg.2, Hon. Gene Dodaro August 18, 2017 All authorities that can be used to hire political appointees at EPA and CEQ, including the policies and procedures, any background and position requirements and limitations, ethics requirements (including but not limited to compliance with the Trump Ethics Pledge), the agency charged with implementation and oversight of each requirement, and which, if any, civil services laws are permitted to be disregarded. Historical and current use of the authorities to employ non-Senate-confirmed political employees, including the types of roles such employees have been hired to perform, the length of service, whether the roles and responsibilities are consistent with the authority and its use during the Obama Administration, and any abuse. of the hiring authorities. This should include a review of the initial authority used to hire an appointee. For non-Senate-confirmed appointees who are required to comply with the Trump Ethics Pledge, please note at what point following their date of hire or date on which they subsequently became subject to the Pledge because their employment status changed; At what point did they agree to comply, receive a written ethics determination regarding any recusals or other measures they needed to take in order to assure compliance; and, if applicable, at what point a waiver was granted. Whether non-Senate-confirmed political appointees who were not subject to Executive Order 13,770 on the date of hire underwent a process to assure their compliance with other applicable ethics regulations. Please detail at what point such a process was completed; at what point they received a written ethical determination regarding any recusals or other measures they needed to take in order to assure compliance; and, if applicable, at what point was a public interest or other determination made regarding their continued work on particular subject matter or participation in certain meetings. For any lag time between the date of hire or transition into a position with different ethics requirements and the date that written ethics analysis or recusal agreements are signed, the extent to which retrospective reviews were conducted to ensure appointees did not violate ethics Executive Order 13,770 or other requirements. Further, determine whether non-confirmed political appointees have been found to have worked on subject matter, communicated with outside groups, or participated in certain meetings that were later determined by the Designated Agency Ethics Official or any other entity to require recusals or other measures. Thank you very much for your consideration of this important matter. If you or members of your staff have any questions or concerns with the contents of this letter, please ask them to contact Michal Freedhoff on the Environment and Public Works Committee staff at 202-224- 8832 and Emily Enderle on Senator Whitehouse's staff at 202-224-2921. Sincerely, Tom Carper Sheldon Whitehouse U.S. Senator U.S. Senator Source: https://www.industrydocuments.ucsf.edu/docs/mlcn0226

What does TSCA stands for?

ylcn0226

ylcn0226_p0, ylcn0226_p1, ylcn0226_p2, ylcn0226_p3, ylcn0226_p4, ylcn0226_p5, ylcn0226_p6, ylcn0226_p7, ylcn0226_p8, ylcn0226_p9

Toxic Substances Control Act, TOXIC SUBSTANCES CONTROL ACT

Search 1/19/17 snapshot Assessing and Managing Chemicals under TSCA Contact Us Share Assessing and Managing Chemicals under The Frank R. Lautenberg TSCA Home Chemical Safety for the How EPA Assesses Chemical Safety 2 1st Century Act Assessments for TSCA Work Plan Chemicals On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for Sign up for Current Chemical the 21st Century Act which amends the Toxic TSCA and Risk Reduction Activities Other Substances Control Act (ISCA), the Nation's Chemical ChemView primary chemicals management law. Safety News Chemical Data Reporting The new law, which received bipartisan support in both the U.S. House of Representatives and Getemail alerts the Senate, includes much needed improvements such as: Enter email address sign up Mandatory requirement for EPA to evaluate existing chemicals with clear and enforceable deadlines; New risk-based safety standard; Increased public transparency for chemical information; and Recent Consistent source of funding for EPA to carry additions out the responsibilities under the new law. Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 American" Chemistry Council August 24, 2016 Wendy Cleland-Hamnett Director, Office of Pollution Prevention and Toxics Environmental Protection Agency 1200 Pennsylvania Ave. NW Washington, DC 20460-0001 Sent electronically to www.regulations.gov docket # EPA-HQ-OPPT-2016-0400 Re: ACC Comments to Inform EPA's Rulemaking on the Conduct of Risk Evaluations under the Lautenberg Chemical Safety Act Dear Ms. Cleland-Hamnett: The American Chemistry Council (ACC¹ appreciates the opportunity to provide input to the Office of Pollution Prevention and Toxics to inform the Agency's development of a risk evaluation rulemaking under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (LCSA). ACC has a long-standing commitment to a robust, science-based approach to evaluation of human and environmental risk. ACC is committed to the effective implementation of the LCSA and supports a workable, rigorous process that allows for timely, high quality reviews. Given the strong emphasis on a risk-based approach in the LCSA, the Section 6(b)(4) rulemaking is particularly important because it will guide the conduct of future risk evaluations that will then inform risk management activities. ACC is committed to being a constructive stakeholder throughout the implementation of LCSA. We will continue to draw from the breadth and depth of our member companies' expertise to ensure that our recommendations are not only science-based, but also allow for the efficient and effective implementation of the LCSA. In doing so, ACC will continue to consider the high quality science standards in the LCSA as well as the timeframes and deadlines imposed therein. The enclosed recommendations were developed with these important considerations in mind. If EPA has any questions, please contact me at nancy [email protected] or 202-249-6417. Sincerely, Nancy B. Beck, PhD, DABT Senior Director, Regulatory and Technical Affairs Cc: Jim Jones, OCSPP Assistant Administrator Louise Wise, Deputy Assistant Administrator Jeffery Morris, Deputy Director for Programs, OPPT Tala Henry, Director, Risk Assessment Division, OPPT 1 The American Chemistry Council (ACC) represents the leading companies engaged in the business of chemistry. More information about ACC is presented in the body of our comments. 1 IPage Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 American Chemistry Council Initial Input to U.S. Environmental Protection Agency In Regard to the Risk Evaluation Rule under the Lautenberg Chemical Safety Act Table of Contents I. Introduction and Executive Summary 4 II. The Risk Evaluation Rulemaking Must Include both Procedural And Substantive Elements to Effect the Purposes of the Statute 5 III. The Proposed Rule Should Include a Tiered Approach to Risk Evaluation 6 IV. The Rule Should Clarify the Process for Preparation and Contents of the Scope 8 V. The Proposed Rule Should Include a Detailed Description of Substantive Elements of Risk Evaluation 8 VI. Proposed Rule Should Ensure Consistency with Section 6(b)(4)(F) 9 a. Integration and Assessment of Information Relevant to Risks and Information on Potentially Exposed and Susceptible Populations 10 i. Conditions of Use That are Relevant 10 ii. Potentially Exposed or Susceptible Subpopulations 10 b. Aggregate and Sentinel Exposures 12 i. Aggregate Exposures 12 ii. Sentinel Exposures 12 c. Exposure Assessment 13 d. Weight of the Evidence 14 VII. The Proposed Rule Should Incorporate Section 26(h) Scientific Standards 14 a. Fit-for-Purpose Approach 15 b. Consideration of Relevant Information 16 i. Improving Hazard Assessment 16 ii. Improving Dose Response Assessment 17 iii. Reliance on Guidance 17 c. Importance of High Quality Risk Characterization 18 d. Clearly Addressing Variability and Uncertainty 18 e. Ensuring Appropriate Peer Review and Forming a Science Advisory Committee on Chemicals 19 21 Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 VIII. The Proposed Rule Should Implement a Weight of the Scientific Evidence (WoE) Approach 20 a. Systematic Review is Required 20 i. Development of a Protocol 21 ii. Search Strategy 21 iii. Transparency 21 b. A Systematic Review is Not Automatically a WoE Assessment 21 c. WoE and Systematic Review for Screening Level Risk Evaluations 22 d. WoE and Systematic Review for Refined Risk Evaluations 22 e. Strength of Evidence is Not the Same as WoE 23 IX. EPA Should Make Information Available Consistent with Section 26(j) 24 X. EPA Should Use Reasonably Available Information and CBI Consistent with Section 26(k) 24 XI. EPA Should Utilize Fit-for-Purpose Exposure Evaluation Tools 25 XII. The Requirements of Sections 6 and 26 Apply to Environmental Risk Evaluations 26 a. Advancing Models for Environmental Risks 27 b. Improving Data Sourcing, Generation, and Evaluation 27 c. Persistent, Bioaccumulative and Toxic (PBT) Substances 28 XIII. EPA Should Leverage International and Inter-Agency Cooperation 28 XIV. Incorporating High Throughput Tools and Alternative Methods 29 XV. Stakeholders and EPA Must Be Held to the Same High Standard 30 APPENDIX A: ACC's Principles for Improving Chemical Hazard and Risk Assessment 31 APPENDIX B: Improving Hazard Assessment 32 APPENDIX C: Improving Does Response Assessment 33 APPRNDIX D: Improving Risk Characterization 35 APPENDIX E: Ensuring Robust Peer Review 37 APPENDIX F: Exposure Modeling Tools 39 APPENDIX G: Additional Information on the ECETOC TRA 41 3 I P a 3 e Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 I. Introduction and Executive Summary The American Chemistry Council (ACC)2 is pleased to provide the U.S. Environmental Protection Agency (EPA) this initial input on the Lautenberg Chemical Safety Act's (LCSA) requirement for the Agency to establish, by rule, the process for conducting risk evaluations. ACC appreciates EPA's early efforts to obtain input from stakeholders at its August 9, 2016, public meeting. We also appreciate EPA's solicitation of written comments to be entered into the docket, well in advance of publication of the proposed rule. Our comments both clarify, as well as supplement and expand upon, the oral comments we presented at the August 9 meeting. ACC strongly supported Congress' efforts to update and reform the Toxic Substances Control Act (TSCA). We believe that high quality risk evaluation, using best available science and weight of the evidence (WoE), is at the very heart of the LCSA. Effective and efficient risk evaluations will help deliver the results intended by Congress. Section 6(b)(4)(B) of the statute requires EPA to establish, by rule, "a process to conduct risk evaluations.' This certainly should include a description of the sequence of events, timelines, opportunities for public comments and peer review. Both Sections 6 and 26 of the LCSA outline various substantive elements that apply to and inform risk evaluation. A risk evaluation must: Be conducted in a manner designed to determine "whether a chemical substance presents an unreasonable risk of injury to health or the environment;" as set out in Section 6(b)(4)(A); Identify whether there exists "an unreasonable risk to a potentially exposed or susceptible subpopulation." EPA must identify potentially exposed or susceptible subpopulations relevant to the risk evaluation under conditions of use; Address the specific elements set out in Section 6(b)(4)(F); and Comply with the specific requirements of Section 26, including the best available science, weight of the evidence, and transparency requirements. Because these elements are at the core of the risk evaluation process, and affect risk management measures, they are substantive and should be described in adequate detail in the regulation. In general, where risk evaluation elements are now required by statute, EPA should apply them uniformly and universally reflecting them in the body of the regulation. The recommendations provided by ACC in these comments address screening and refined risk evaluations and are meant to apply to both human health and environmental risks. Specific tools, testing methods, databases, and the like may develop over time, or course, and can be updated as necessary in policies, 2 The American Chemistry Council (ACC) represents the leading companies engaged in the business of chemistry. ACC members apply the science of chemistry to make innovative products and services that make people's lives better, healthier and safer. ACC is committed to improved environmental, health and safety performance through Responsible Care common sense advocacy designed to address major public policy issues, and health and environmental research and product testing. The business of chemistry is a $797 billion enterprise and a key element of the nation's economy. It is the nation's largest exporter, accounting for fourteen percent of all U.S. exports. Chemistry companies are among the largest investors in research and development. Safety and security have always been primary concerns of ACC members, and they have intensified their efforts, working closely with government agencies to improve security and to defend against any threat to the nation's critical infrastructure. 4 Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 procedures and guidance. Our comments strive to make these differentiations and explain where particular elements of risk evaluation should be included in the rule proper. Specifically, our recommendations suggest definitions, and procedural steps and elements that will allow EPA to ensure that risk evaluations are consistent with the statutory requirements for EPA to use the best available science and WoE approaches. The recommendations also include definitions and procedural steps are not expected to change over time. ACC has referenced each of our suggestions to an existing EPA guidance, a National Academies (NAS) report, or another authoritative body or peer reviewed report. For instance, the recommendations in EPA's 2000 Risk Characterization Handbook still represent best practices today. Adding adequate definitions and explanation to the rule is particularly important to achieving incorporation of statutory requirements. We also note that in addition to Section 6, Sections 26(h), 26(i), 26(j), and 26(k) of the LCSA each present legal requirements that are applicable to the risk evaluation. EPA will now need to provide a level of transparency regarding not only the inputs, but also the methods of the analysis, including clear descriptions of uncertainties and variability. EPA should leverage information from other jurisdictions where data and information is applicable and of sufficient quality to meet the science standards in the LCSA. Incorporating these elements into the rulemaking creates a better platform for clear and consistent articulation of the Agency's understanding of statutory requirements, and will better support consistent and uniform application of the elements of risk evaluation. It is critically important that EPA engage the public as EPA plans, scopes, and conducts risk evaluations. Industry scientists often have unique insight and experience with their companies' chemistries and collectively have a large body of knowledge of risk assessment processes globally, including an understanding of potential human health and environmental impacts. ACC encourages EPA to leverage this knowledge and engage early (well before draft risk evaluations are released) and frequently with industry throughout the risk evaluation process. II. The Risk Evaluation Rulemaking Must Include both Procedural and Substantive Elements to Effect the Purposes of the Statute Congress included a specific mandate to EPA to establish a risk evaluation rulemaking. There is little question that the rule must describe the process by which risk evaluations will be conducted. However, to 3 effect the purposes of the statute, the process described in the rule cannot merely set out timelines or the sequence of the risk evaluation. It must include a clear articulation of the substantive elements of risk evaluation, and more particularly, it must explain how it will apply the principles set out in Section 6(b)(4)(F), Section 26, and other parts of the statute. If Congress had intended the scientific standard of "best available science" or "weight of the scientific evidence" to be incorporated into guidance alone, it would have included them only in Section 26(1) on "policies, procedures and guidance." 3 "[T]he Administrator shall establish, by rule, a process to conduct risk evaluations in accordance with subparagraph (A) " Section 6(b)(4)(A). 5 I Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 The very purpose of the risk evaluation is to develop the evidentiary and scientific basis to enable EPA to complete the risk determination required by statute. That risk determination has substantive impact - it significantly affects conduct, activity or a substantive interest that is the subject of agency regulation. The determination following risk evaluation is a necessary prerequisite for a chemical to proceed to risk management, if warranted. The rule should thus include a clear description of how EPA will undertake risk evaluations in order to meet the new statutory requirements of the LCSA. This includes a description of the scoping process and requirements for a published scope as well as the elements of the risk evaluation itself and the mechanism for gauging adequacy as measured against statutory criteria. III. The Proposed Rule Should Include a Tiered Approach to Risk Evaluation We believe the statute contemplates a tiered approach to risk evaluation and recommend that EPA include a tiered approach in the rule. Under the LCSA, EPA must initiate the risk evaluation "upon designating" a chemical as a high-priority substance. The scope, however, is not required to be published "upon initiation" -- EPA has up to six months following the initiation of the risk evaluation to prepare and publish the scope. Congress intended this six month period to be used for a scoping exercise, where EPA identifies "the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations the Administrator expects to consider in the risk evaluation." This six month period is a "step" between the high priority designation and the publication of the scope. In order for EPA to conduct risk evaluations consistent with the quality required by the LCSA and within the timeframes required, EPA should conduct a screening level evaluation during the scoping phase. During the scoping phase of risk evaluations, tools exist to allow EPA to conduct quantitative screening level analyses of multiple exposure scenarios, as appropriate for consumers, sensitive subpopulations, and the environment. This will allow EPA to have a more tailored focus on those populations and exposures of greatest concern during a refined risk evaluation process. Figure 1 below depicts ACC's recommended approach. 6 I Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 - y 10 Worknlan High-Duality Refined Risk Evaluation High Pricrity Chemicats & DRAFT Chemicals Manufacturer Risk Evaluation Requested EXPOSSURES HAZARD Evaluation incorporating Sections 6 and 26 of the Lautenberg Chemicel Safety Act (LCSA): Scope/Screening Level Risk Evatuation Scientific Standards FINAL Susceprible Weight of Scientific Evidence Evaluations Risk Evaluation Exposures Pupulations or use Certain Conditions of Use Present Do not present an anreasonable risk an unreasonable risk Refined No further risk evaluation risk avaluation No further action; needed RUREMAKING PROCESS COMPLETE the Figure 1. A Two-Step Process for Conducting Risk Evaluations Note: This is a simplified version of the process. A tiered approach, where EPA uses the scoping step (step 1) to conduct a quantitative screening level analysis, will allow EPA to focus its limited resources on more robust refined risk evaluations for only those conditions of use where unreasonable risks cannot be ruled out. Screening-level assessments require less data and information, and are typically deterministic and based on conservative, health protective assumptions and methods. When a screening assessment indicates low risk for a particular condition of use, the Agency should have a high degree of confidence that the potential risks are much lower than the calculation and, therefore, the actual risks are lower and/or perhaps non-existent. However, when a screening-level risk assessment indicates a potential concern for an adverse effect, this does not mean that the actual risks are significant and warrant action. Rather, it indicates the Agency should take a second step in the risk evaluation process to refine the evaluation to more accurately quantify potential risks. The refined risk evaluation (step 2) will require realistic and representative data, higher tier modeling approaches, including probabilistic exposure modeling, and a more comprehensive consideration of human relevance and dose-response relationships. In a refined evaluation, EPA should also consider targeted exposure studies, as well as biomonitoring and environmental monitoring data, to the extent that this information is available and relevant. This approach is consistent with EPA's 2014 Framework for Human Health Risk Assessment to Inform Decision Making (HHRA Framework)4. which also emphasizes the importance of a fit-for-purpose approach to risk evaluation. This approach is also consistent with EPA's exposure assessment guidelines and practices. The concept of a tiered approach and a fit-for-purpose 5 evaluation are woven throughout ACC's recommendations. 4 See tps://www.epa.gov/sites/production/files/2014-12/documents/hhra-framework-final-2014.pdf. 5 See: tps://www.epa.gov/expobox/exposure-assessment-tools-tiers-and-types-screening-level-and-refined. 7 Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 The tiered approach ACC recommends is consistent with the approach EPA took in the problem formulation and initial assessment document for tetrabromobisphenol A (TBBPA.6 In that document, EPA conducted an initial screening level evaluation to support its conceptual model and analysis plan. EPA appropriately used high-end exposure values coupled with the lowest toxicity values to evaluate uses and exposure pathways of potential concern. While EPA did not share the relevant risk evaluation calculations in its public document, the general approach is consistent with that of a screening level risk evaluation. ACC encourages EPA to continue with this approach and to transparently and clearly present quantitative screening level analyses for the conditions of use and exposure scenarios that are part of the conceptual model EPA develops as part of the scoping phase. IV. The Rule Should Clarify the Process for Preparation and Contents of the Scope As noted above, Congress allowed a six month period for preparation of the scope of the risk evaluation, contemplating that time and effort would be needed to move from prioritization to a published scope. The six month period is to enable EPA to identify "the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations the Administrator expects to consider in the risk evaluation." Two things are evident from this language and the time frame afforded: 1) EPA should use this period to evaluate and decide which, if any, potentially exposed or susceptible subpopulations should be included in the risk evaluation (in other words, it need not include all such subpopulations, regardless of size, impact, or relevance); and 2) tEPA has flexibility to actually conduct a full risk evaluation of some or all the potential scenarios set out in the scope. In short, EPA need not include every conceivable condition of use in a risk evaluation. This view is further buttressed by the definition of "conditions of use" in Section 3 of the LCSA, which points to the need for EPA to determine the relevant conditions of use: "the circumstances, as determined by the Administrator, under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of." (Emphasis added). V. The Proposed Rule Should Include a Detailed Description of Substantive Elements of Risk Evaluation The term, "risk evaluation" is not expressly defined in the LCSA. While the term "risk assessment" has been widely used in EPA programs and operationally has clear meaning derived from years of guidance, policies and practices, that term was not used in the statute. Therefore even though it may be reasonable to assume "risk evaluation" may fully equate with the term "risk assessment," given the context of its use (integrating hazard with exposure) in the LCSA, EPA is encouraged to explicitly define and operationalize this term as part of its rulemaking. The term will not have clear meaning until an interpretation is assigned by EPA. We believe the essential elements of a Section 6 and 26 risk evaluation must be articulated in a clear regulatory definition as we discuss below. 6 EPA, Problem Formulation and Initial Assessment Tetrabromobisphenol A and Related Chemicals Cluster Flame Retardants, 2015, available at: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/tsca-work-plan-chemical-problem- formulation-and-2. 8 IPage Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 Section 6(b)(4)(B) of the statute requires EPA to establish, by rule, "a process to conduct risk evaluations." This process is itself required to meet a number of substantive elements described in the LCSA; a risk evaluation must: Be conducted in a manner designed to help the agency determine "whether a chemical substance presents an unreasonable risk of injury to health or the environment;" as set out in Section 6(b)(4)(A). Include consideration of "an unreasonable risk to a potentially exposed or susceptible subpopulation." EPA must identify relevant potentially exposed or susceptible subpopulations relevant to the risk evaluation under conditions of use; Address the specific elements set out in Section 6(b)(4)(F); and Comply with the specific requirements of Section 26, including the best available science, weight of the evidence, and transparency requirements. The very purpose of the risk evaluation is to develop the evidentiary and scientific basis to enable EPA to complete the risk determination required by statute. That risk determination has substantive impact - it significantly affects conduct, activity or a substantive interest that is the subject of agency regulation. The basis for the risk determination thus should be adequately described in the rule itself to offer sufficient notice to the regulated community. This is particularly important for decisions that inform safety and safety determinations. Likewise, decisions that have broad reaching impact should be supported in regulations, not merely through guidance or agency policy. 8 While EPA cannot substitute policy or guidance for a regulatory description of what will constitute a complete and robust risk evaluation, we believe the necessary elements can be developed in this rulemaking in a timely manner. VI. The Proposed Rule Should Ensure Consistency with Section 6(b)(4)(F) As discussed below, Section 6(b)(4)(F) of the LCSA describes five requirements for risk evaluations that shall be considered by the Administrator and must be incorporated into the risk evaluation rulemaking. 7 See, e.g., MST Express v. U.S. Department of Transportation, 108 F.3d 401 (D.C. Cir. 1997). DOT was directed under the Motor Carrier Safety Act (MCSA) to "prescribe regulations establishing a procedure to decide on the safety fitness of owners and operators of commercial motor vehicles." [Emphasis added]. The MCSA stated that implementing regulations would include "a means of deciding whether the owners, operators, and persons meet the safety fitness requirements." DOT promulgated regulations that set out a process for decision making but used guidance to articulate the tests by which the agency would determine whether vehicles met the safety fitness requirements. The court rejected DOT's reliance on guidance because it "failed to carry out its statutory obligation to establish by regulation a means of determining whether a carrier has complied with the safety fitness requirements." 8 As a general matter, "...it seems to be established that "regulations,' 'substantive rules' or 'legislative rules' are those which create law, usually implementary to an existing law." Gibson Wine Co. v. Snyder, 194 F.2d 329, 331 (D.C. Cir. 1952), cited by Brown Express, Inc. v. U.S., 607 F.2d 695, 700 (5th Cir. 1979). A "rule" is defined under Section 2 of the Administrative Procedure Act, in relevant part, as: "the whole or part of an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy or describing the organization, procedure, or practice requirements of an agency." 5 U.S.C. § 551(4). 9 I Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226

What will help deliver the results intended by congress?

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ylcn0226_p0, ylcn0226_p1, ylcn0226_p2, ylcn0226_p3, ylcn0226_p4, ylcn0226_p5, ylcn0226_p6, ylcn0226_p7, ylcn0226_p8, ylcn0226_p9

Effective and efficient risk evaluations

Search 1/19/17 snapshot Assessing and Managing Chemicals under TSCA Contact Us Share Assessing and Managing Chemicals under The Frank R. Lautenberg TSCA Home Chemical Safety for the How EPA Assesses Chemical Safety 2 1st Century Act Assessments for TSCA Work Plan Chemicals On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for Sign up for Current Chemical the 21st Century Act which amends the Toxic TSCA and Risk Reduction Activities Other Substances Control Act (ISCA), the Nation's Chemical ChemView primary chemicals management law. Safety News Chemical Data Reporting The new law, which received bipartisan support in both the U.S. House of Representatives and Getemail alerts the Senate, includes much needed improvements such as: Enter email address sign up Mandatory requirement for EPA to evaluate existing chemicals with clear and enforceable deadlines; New risk-based safety standard; Increased public transparency for chemical information; and Recent Consistent source of funding for EPA to carry additions out the responsibilities under the new law. Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 American" Chemistry Council August 24, 2016 Wendy Cleland-Hamnett Director, Office of Pollution Prevention and Toxics Environmental Protection Agency 1200 Pennsylvania Ave. NW Washington, DC 20460-0001 Sent electronically to www.regulations.gov docket # EPA-HQ-OPPT-2016-0400 Re: ACC Comments to Inform EPA's Rulemaking on the Conduct of Risk Evaluations under the Lautenberg Chemical Safety Act Dear Ms. Cleland-Hamnett: The American Chemistry Council (ACC¹ appreciates the opportunity to provide input to the Office of Pollution Prevention and Toxics to inform the Agency's development of a risk evaluation rulemaking under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (LCSA). ACC has a long-standing commitment to a robust, science-based approach to evaluation of human and environmental risk. ACC is committed to the effective implementation of the LCSA and supports a workable, rigorous process that allows for timely, high quality reviews. Given the strong emphasis on a risk-based approach in the LCSA, the Section 6(b)(4) rulemaking is particularly important because it will guide the conduct of future risk evaluations that will then inform risk management activities. ACC is committed to being a constructive stakeholder throughout the implementation of LCSA. We will continue to draw from the breadth and depth of our member companies' expertise to ensure that our recommendations are not only science-based, but also allow for the efficient and effective implementation of the LCSA. In doing so, ACC will continue to consider the high quality science standards in the LCSA as well as the timeframes and deadlines imposed therein. The enclosed recommendations were developed with these important considerations in mind. If EPA has any questions, please contact me at nancy [email protected] or 202-249-6417. Sincerely, Nancy B. Beck, PhD, DABT Senior Director, Regulatory and Technical Affairs Cc: Jim Jones, OCSPP Assistant Administrator Louise Wise, Deputy Assistant Administrator Jeffery Morris, Deputy Director for Programs, OPPT Tala Henry, Director, Risk Assessment Division, OPPT 1 The American Chemistry Council (ACC) represents the leading companies engaged in the business of chemistry. More information about ACC is presented in the body of our comments. 1 IPage Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 American Chemistry Council Initial Input to U.S. Environmental Protection Agency In Regard to the Risk Evaluation Rule under the Lautenberg Chemical Safety Act Table of Contents I. Introduction and Executive Summary 4 II. The Risk Evaluation Rulemaking Must Include both Procedural And Substantive Elements to Effect the Purposes of the Statute 5 III. The Proposed Rule Should Include a Tiered Approach to Risk Evaluation 6 IV. The Rule Should Clarify the Process for Preparation and Contents of the Scope 8 V. The Proposed Rule Should Include a Detailed Description of Substantive Elements of Risk Evaluation 8 VI. Proposed Rule Should Ensure Consistency with Section 6(b)(4)(F) 9 a. Integration and Assessment of Information Relevant to Risks and Information on Potentially Exposed and Susceptible Populations 10 i. Conditions of Use That are Relevant 10 ii. Potentially Exposed or Susceptible Subpopulations 10 b. Aggregate and Sentinel Exposures 12 i. Aggregate Exposures 12 ii. Sentinel Exposures 12 c. Exposure Assessment 13 d. Weight of the Evidence 14 VII. The Proposed Rule Should Incorporate Section 26(h) Scientific Standards 14 a. Fit-for-Purpose Approach 15 b. Consideration of Relevant Information 16 i. Improving Hazard Assessment 16 ii. Improving Dose Response Assessment 17 iii. Reliance on Guidance 17 c. Importance of High Quality Risk Characterization 18 d. Clearly Addressing Variability and Uncertainty 18 e. Ensuring Appropriate Peer Review and Forming a Science Advisory Committee on Chemicals 19 21 Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 VIII. The Proposed Rule Should Implement a Weight of the Scientific Evidence (WoE) Approach 20 a. Systematic Review is Required 20 i. Development of a Protocol 21 ii. Search Strategy 21 iii. Transparency 21 b. A Systematic Review is Not Automatically a WoE Assessment 21 c. WoE and Systematic Review for Screening Level Risk Evaluations 22 d. WoE and Systematic Review for Refined Risk Evaluations 22 e. Strength of Evidence is Not the Same as WoE 23 IX. EPA Should Make Information Available Consistent with Section 26(j) 24 X. EPA Should Use Reasonably Available Information and CBI Consistent with Section 26(k) 24 XI. EPA Should Utilize Fit-for-Purpose Exposure Evaluation Tools 25 XII. The Requirements of Sections 6 and 26 Apply to Environmental Risk Evaluations 26 a. Advancing Models for Environmental Risks 27 b. Improving Data Sourcing, Generation, and Evaluation 27 c. Persistent, Bioaccumulative and Toxic (PBT) Substances 28 XIII. EPA Should Leverage International and Inter-Agency Cooperation 28 XIV. Incorporating High Throughput Tools and Alternative Methods 29 XV. Stakeholders and EPA Must Be Held to the Same High Standard 30 APPENDIX A: ACC's Principles for Improving Chemical Hazard and Risk Assessment 31 APPENDIX B: Improving Hazard Assessment 32 APPENDIX C: Improving Does Response Assessment 33 APPRNDIX D: Improving Risk Characterization 35 APPENDIX E: Ensuring Robust Peer Review 37 APPENDIX F: Exposure Modeling Tools 39 APPENDIX G: Additional Information on the ECETOC TRA 41 3 I P a 3 e Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 I. Introduction and Executive Summary The American Chemistry Council (ACC)2 is pleased to provide the U.S. Environmental Protection Agency (EPA) this initial input on the Lautenberg Chemical Safety Act's (LCSA) requirement for the Agency to establish, by rule, the process for conducting risk evaluations. ACC appreciates EPA's early efforts to obtain input from stakeholders at its August 9, 2016, public meeting. We also appreciate EPA's solicitation of written comments to be entered into the docket, well in advance of publication of the proposed rule. Our comments both clarify, as well as supplement and expand upon, the oral comments we presented at the August 9 meeting. ACC strongly supported Congress' efforts to update and reform the Toxic Substances Control Act (TSCA). We believe that high quality risk evaluation, using best available science and weight of the evidence (WoE), is at the very heart of the LCSA. Effective and efficient risk evaluations will help deliver the results intended by Congress. Section 6(b)(4)(B) of the statute requires EPA to establish, by rule, "a process to conduct risk evaluations.' This certainly should include a description of the sequence of events, timelines, opportunities for public comments and peer review. Both Sections 6 and 26 of the LCSA outline various substantive elements that apply to and inform risk evaluation. A risk evaluation must: Be conducted in a manner designed to determine "whether a chemical substance presents an unreasonable risk of injury to health or the environment;" as set out in Section 6(b)(4)(A); Identify whether there exists "an unreasonable risk to a potentially exposed or susceptible subpopulation." EPA must identify potentially exposed or susceptible subpopulations relevant to the risk evaluation under conditions of use; Address the specific elements set out in Section 6(b)(4)(F); and Comply with the specific requirements of Section 26, including the best available science, weight of the evidence, and transparency requirements. Because these elements are at the core of the risk evaluation process, and affect risk management measures, they are substantive and should be described in adequate detail in the regulation. In general, where risk evaluation elements are now required by statute, EPA should apply them uniformly and universally reflecting them in the body of the regulation. The recommendations provided by ACC in these comments address screening and refined risk evaluations and are meant to apply to both human health and environmental risks. Specific tools, testing methods, databases, and the like may develop over time, or course, and can be updated as necessary in policies, 2 The American Chemistry Council (ACC) represents the leading companies engaged in the business of chemistry. ACC members apply the science of chemistry to make innovative products and services that make people's lives better, healthier and safer. ACC is committed to improved environmental, health and safety performance through Responsible Care common sense advocacy designed to address major public policy issues, and health and environmental research and product testing. The business of chemistry is a $797 billion enterprise and a key element of the nation's economy. It is the nation's largest exporter, accounting for fourteen percent of all U.S. exports. Chemistry companies are among the largest investors in research and development. Safety and security have always been primary concerns of ACC members, and they have intensified their efforts, working closely with government agencies to improve security and to defend against any threat to the nation's critical infrastructure. 4 Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 procedures and guidance. Our comments strive to make these differentiations and explain where particular elements of risk evaluation should be included in the rule proper. Specifically, our recommendations suggest definitions, and procedural steps and elements that will allow EPA to ensure that risk evaluations are consistent with the statutory requirements for EPA to use the best available science and WoE approaches. The recommendations also include definitions and procedural steps are not expected to change over time. ACC has referenced each of our suggestions to an existing EPA guidance, a National Academies (NAS) report, or another authoritative body or peer reviewed report. For instance, the recommendations in EPA's 2000 Risk Characterization Handbook still represent best practices today. Adding adequate definitions and explanation to the rule is particularly important to achieving incorporation of statutory requirements. We also note that in addition to Section 6, Sections 26(h), 26(i), 26(j), and 26(k) of the LCSA each present legal requirements that are applicable to the risk evaluation. EPA will now need to provide a level of transparency regarding not only the inputs, but also the methods of the analysis, including clear descriptions of uncertainties and variability. EPA should leverage information from other jurisdictions where data and information is applicable and of sufficient quality to meet the science standards in the LCSA. Incorporating these elements into the rulemaking creates a better platform for clear and consistent articulation of the Agency's understanding of statutory requirements, and will better support consistent and uniform application of the elements of risk evaluation. It is critically important that EPA engage the public as EPA plans, scopes, and conducts risk evaluations. Industry scientists often have unique insight and experience with their companies' chemistries and collectively have a large body of knowledge of risk assessment processes globally, including an understanding of potential human health and environmental impacts. ACC encourages EPA to leverage this knowledge and engage early (well before draft risk evaluations are released) and frequently with industry throughout the risk evaluation process. II. The Risk Evaluation Rulemaking Must Include both Procedural and Substantive Elements to Effect the Purposes of the Statute Congress included a specific mandate to EPA to establish a risk evaluation rulemaking. There is little question that the rule must describe the process by which risk evaluations will be conducted. However, to 3 effect the purposes of the statute, the process described in the rule cannot merely set out timelines or the sequence of the risk evaluation. It must include a clear articulation of the substantive elements of risk evaluation, and more particularly, it must explain how it will apply the principles set out in Section 6(b)(4)(F), Section 26, and other parts of the statute. If Congress had intended the scientific standard of "best available science" or "weight of the scientific evidence" to be incorporated into guidance alone, it would have included them only in Section 26(1) on "policies, procedures and guidance." 3 "[T]he Administrator shall establish, by rule, a process to conduct risk evaluations in accordance with subparagraph (A) " Section 6(b)(4)(A). 5 I Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 The very purpose of the risk evaluation is to develop the evidentiary and scientific basis to enable EPA to complete the risk determination required by statute. That risk determination has substantive impact - it significantly affects conduct, activity or a substantive interest that is the subject of agency regulation. The determination following risk evaluation is a necessary prerequisite for a chemical to proceed to risk management, if warranted. The rule should thus include a clear description of how EPA will undertake risk evaluations in order to meet the new statutory requirements of the LCSA. This includes a description of the scoping process and requirements for a published scope as well as the elements of the risk evaluation itself and the mechanism for gauging adequacy as measured against statutory criteria. III. The Proposed Rule Should Include a Tiered Approach to Risk Evaluation We believe the statute contemplates a tiered approach to risk evaluation and recommend that EPA include a tiered approach in the rule. Under the LCSA, EPA must initiate the risk evaluation "upon designating" a chemical as a high-priority substance. The scope, however, is not required to be published "upon initiation" -- EPA has up to six months following the initiation of the risk evaluation to prepare and publish the scope. Congress intended this six month period to be used for a scoping exercise, where EPA identifies "the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations the Administrator expects to consider in the risk evaluation." This six month period is a "step" between the high priority designation and the publication of the scope. In order for EPA to conduct risk evaluations consistent with the quality required by the LCSA and within the timeframes required, EPA should conduct a screening level evaluation during the scoping phase. During the scoping phase of risk evaluations, tools exist to allow EPA to conduct quantitative screening level analyses of multiple exposure scenarios, as appropriate for consumers, sensitive subpopulations, and the environment. This will allow EPA to have a more tailored focus on those populations and exposures of greatest concern during a refined risk evaluation process. Figure 1 below depicts ACC's recommended approach. 6 I Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 - y 10 Worknlan High-Duality Refined Risk Evaluation High Pricrity Chemicats & DRAFT Chemicals Manufacturer Risk Evaluation Requested EXPOSSURES HAZARD Evaluation incorporating Sections 6 and 26 of the Lautenberg Chemicel Safety Act (LCSA): Scope/Screening Level Risk Evatuation Scientific Standards FINAL Susceprible Weight of Scientific Evidence Evaluations Risk Evaluation Exposures Pupulations or use Certain Conditions of Use Present Do not present an anreasonable risk an unreasonable risk Refined No further risk evaluation risk avaluation No further action; needed RUREMAKING PROCESS COMPLETE the Figure 1. A Two-Step Process for Conducting Risk Evaluations Note: This is a simplified version of the process. A tiered approach, where EPA uses the scoping step (step 1) to conduct a quantitative screening level analysis, will allow EPA to focus its limited resources on more robust refined risk evaluations for only those conditions of use where unreasonable risks cannot be ruled out. Screening-level assessments require less data and information, and are typically deterministic and based on conservative, health protective assumptions and methods. When a screening assessment indicates low risk for a particular condition of use, the Agency should have a high degree of confidence that the potential risks are much lower than the calculation and, therefore, the actual risks are lower and/or perhaps non-existent. However, when a screening-level risk assessment indicates a potential concern for an adverse effect, this does not mean that the actual risks are significant and warrant action. Rather, it indicates the Agency should take a second step in the risk evaluation process to refine the evaluation to more accurately quantify potential risks. The refined risk evaluation (step 2) will require realistic and representative data, higher tier modeling approaches, including probabilistic exposure modeling, and a more comprehensive consideration of human relevance and dose-response relationships. In a refined evaluation, EPA should also consider targeted exposure studies, as well as biomonitoring and environmental monitoring data, to the extent that this information is available and relevant. This approach is consistent with EPA's 2014 Framework for Human Health Risk Assessment to Inform Decision Making (HHRA Framework)4. which also emphasizes the importance of a fit-for-purpose approach to risk evaluation. This approach is also consistent with EPA's exposure assessment guidelines and practices. The concept of a tiered approach and a fit-for-purpose 5 evaluation are woven throughout ACC's recommendations. 4 See tps://www.epa.gov/sites/production/files/2014-12/documents/hhra-framework-final-2014.pdf. 5 See: tps://www.epa.gov/expobox/exposure-assessment-tools-tiers-and-types-screening-level-and-refined. 7 Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 The tiered approach ACC recommends is consistent with the approach EPA took in the problem formulation and initial assessment document for tetrabromobisphenol A (TBBPA.6 In that document, EPA conducted an initial screening level evaluation to support its conceptual model and analysis plan. EPA appropriately used high-end exposure values coupled with the lowest toxicity values to evaluate uses and exposure pathways of potential concern. While EPA did not share the relevant risk evaluation calculations in its public document, the general approach is consistent with that of a screening level risk evaluation. ACC encourages EPA to continue with this approach and to transparently and clearly present quantitative screening level analyses for the conditions of use and exposure scenarios that are part of the conceptual model EPA develops as part of the scoping phase. IV. The Rule Should Clarify the Process for Preparation and Contents of the Scope As noted above, Congress allowed a six month period for preparation of the scope of the risk evaluation, contemplating that time and effort would be needed to move from prioritization to a published scope. The six month period is to enable EPA to identify "the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations the Administrator expects to consider in the risk evaluation." Two things are evident from this language and the time frame afforded: 1) EPA should use this period to evaluate and decide which, if any, potentially exposed or susceptible subpopulations should be included in the risk evaluation (in other words, it need not include all such subpopulations, regardless of size, impact, or relevance); and 2) tEPA has flexibility to actually conduct a full risk evaluation of some or all the potential scenarios set out in the scope. In short, EPA need not include every conceivable condition of use in a risk evaluation. This view is further buttressed by the definition of "conditions of use" in Section 3 of the LCSA, which points to the need for EPA to determine the relevant conditions of use: "the circumstances, as determined by the Administrator, under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of." (Emphasis added). V. The Proposed Rule Should Include a Detailed Description of Substantive Elements of Risk Evaluation The term, "risk evaluation" is not expressly defined in the LCSA. While the term "risk assessment" has been widely used in EPA programs and operationally has clear meaning derived from years of guidance, policies and practices, that term was not used in the statute. Therefore even though it may be reasonable to assume "risk evaluation" may fully equate with the term "risk assessment," given the context of its use (integrating hazard with exposure) in the LCSA, EPA is encouraged to explicitly define and operationalize this term as part of its rulemaking. The term will not have clear meaning until an interpretation is assigned by EPA. We believe the essential elements of a Section 6 and 26 risk evaluation must be articulated in a clear regulatory definition as we discuss below. 6 EPA, Problem Formulation and Initial Assessment Tetrabromobisphenol A and Related Chemicals Cluster Flame Retardants, 2015, available at: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/tsca-work-plan-chemical-problem- formulation-and-2. 8 IPage Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 Section 6(b)(4)(B) of the statute requires EPA to establish, by rule, "a process to conduct risk evaluations." This process is itself required to meet a number of substantive elements described in the LCSA; a risk evaluation must: Be conducted in a manner designed to help the agency determine "whether a chemical substance presents an unreasonable risk of injury to health or the environment;" as set out in Section 6(b)(4)(A). Include consideration of "an unreasonable risk to a potentially exposed or susceptible subpopulation." EPA must identify relevant potentially exposed or susceptible subpopulations relevant to the risk evaluation under conditions of use; Address the specific elements set out in Section 6(b)(4)(F); and Comply with the specific requirements of Section 26, including the best available science, weight of the evidence, and transparency requirements. The very purpose of the risk evaluation is to develop the evidentiary and scientific basis to enable EPA to complete the risk determination required by statute. That risk determination has substantive impact - it significantly affects conduct, activity or a substantive interest that is the subject of agency regulation. The basis for the risk determination thus should be adequately described in the rule itself to offer sufficient notice to the regulated community. This is particularly important for decisions that inform safety and safety determinations. Likewise, decisions that have broad reaching impact should be supported in regulations, not merely through guidance or agency policy. 8 While EPA cannot substitute policy or guidance for a regulatory description of what will constitute a complete and robust risk evaluation, we believe the necessary elements can be developed in this rulemaking in a timely manner. VI. The Proposed Rule Should Ensure Consistency with Section 6(b)(4)(F) As discussed below, Section 6(b)(4)(F) of the LCSA describes five requirements for risk evaluations that shall be considered by the Administrator and must be incorporated into the risk evaluation rulemaking. 7 See, e.g., MST Express v. U.S. Department of Transportation, 108 F.3d 401 (D.C. Cir. 1997). DOT was directed under the Motor Carrier Safety Act (MCSA) to "prescribe regulations establishing a procedure to decide on the safety fitness of owners and operators of commercial motor vehicles." [Emphasis added]. The MCSA stated that implementing regulations would include "a means of deciding whether the owners, operators, and persons meet the safety fitness requirements." DOT promulgated regulations that set out a process for decision making but used guidance to articulate the tests by which the agency would determine whether vehicles met the safety fitness requirements. The court rejected DOT's reliance on guidance because it "failed to carry out its statutory obligation to establish by regulation a means of determining whether a carrier has complied with the safety fitness requirements." 8 As a general matter, "...it seems to be established that "regulations,' 'substantive rules' or 'legislative rules' are those which create law, usually implementary to an existing law." Gibson Wine Co. v. Snyder, 194 F.2d 329, 331 (D.C. Cir. 1952), cited by Brown Express, Inc. v. U.S., 607 F.2d 695, 700 (5th Cir. 1979). A "rule" is defined under Section 2 of the Administrative Procedure Act, in relevant part, as: "the whole or part of an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy or describing the organization, procedure, or practice requirements of an agency." 5 U.S.C. § 551(4). 9 I Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226

who said that EPA"is given the discretion to determine the conditions of use that the agency will address in its evaluation of the priority chemical"

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senator vitter

At the same time, risk evaluations must meet Section 26 quality requirements, using best available science and weight of the evidence review. To achieve the throughput and quality requirements for risk evaluation, Congress designed a process to allow chemicals to be systematically prioritized and evaluated. This design is apparent throughout LCSA. It begins with a reset of the TSCA Inventory -- the full catalog of chemicals in commerce. LCSA requires that the TSCA Inventory be sorted, so that chemicals that are currently active in commerce are separated from those not currently used. This sorting enables EPA to identify only those chemicals that are active in commerce for prioritization and risk evaluation. This statutory design makes eminent sense: it allows EPA to focus resources for its multi-year, time- and resource-intensive risk evaluations on chemicals that are actually being used. From this initial focusing step, LCSA repeatedly requires EPA to further refine its focus throughout prioritization and risk evaluation. EPA must next implement a prioritization process, which further refines the active chemicals in commerce to those that are high priority for risk evaluation. These chemicals must then undergo a scoping exercise to further focus on the conditions of use that will be the subject of the risk evaluation. In implementing LCSA, EPA has indicated that it intends to identify and consider all conditions of use of a chemical in all risk evaluations, all the time. This interpretation cannot be reconciled with EPA's statutory directive to achieve throughput and quality in risk evaluations. It is inconsistent with the design of the statute; inconsistent with congressional intent to give EPA the flexibility to make case-by-case scoping decisions; and undermines statutory purposes and the effective function of the statute itself. A. There is No Statutory Mandate to Include All Conditions of Use in the Scope of Every Risk Evaluation Under TSCA § 6(b). EPA notes in the preamble that, prior to enactment of LCSA, the Agency was "free to and did" conduct risk assessments on selected uses of chemical substances, but that it now interprets the amended statute as "requiring that risk evaluations encompass all manufacture, processing, distribution in commerce, use, and disposal activities [t]hat is to say, a risk evaluation must encompass all known, intended, and reasonably foreseen activities associated with the subject chemical substance" [emphasis added]. ACC strongly disagrees with this interpretation -- EPA 3 is reading a mandate into the statute where none exists. Rather, Congress equipped EPA with the tools to scope risk evaluations in order to achieve statutory purposes, and EPA should use those tools accordingly. The statute does not require EPA to include "all" conditions of use in any particular risk evaluation, or in each and every risk evaluation. Nowhere in the statute does Congress modify "conditions of use" with "all." EPA has the discretion to interpret the term. It cannot apply this discretion in such a manner, however, as to undercut the operation of the statute or to make it impossible for EPA to meet its statutory objectives of throughput and quality. 3 82 Fed. Reg. at 7565. 4/Page Source: https://www.industrydocuments.ucsf.edu/docs/kzbn0226 B. Scoping Necessarily Requires EPA to Select Relevant Conditions of Use for Inclusion, and Scope Accordingly. LCSA requires EPA to conduct risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment under certain circumstances called "conditions of use. ,,4 Conditions of use are defined as "the circumstances, as determined by [EPA], under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of." The legislative text did not direct EPA to include "all" conditions of use. The statute creates a scoping process that precedes the risk evaluation itself. For a scoping process to have any reasonable meaning, it must actually "scope" -- on a case by case basis, it must determine which conditions of use are appropriate for inclusion because they are relevant and meaningful to the risk evaluation process. EPA's plan to universally include "all conditions of use" all the time in every risk evaluation is contrary to common sense, conflicts with and undermines the statutory design of TSCA as amended by LCSA, and would lead to an absurd result. 5 EPA's preamble acknowledges the value of scoping (also called problem formulation) in citing the National Academy of Sciences (NAS) National Research Council (NRC) Science and Decisions Report. The NAS report recommended that EPA focus on the "important roles of scoping or problem formulation so that a risk assessment will serve a specific and documented purpose" [emphasis added]. The preamble cites an additional NAS recommendation to EPA 6 that the Agency "develop risk assessments that are well-tailored to the problems and decisions at hand so that they can inform the decision-making process in the most meaningful way." We agree, and urge the agency to apply these recommendations to the scoping process. C. The Legislative Text Acknowledges that What EPA Will Consider and Include in a Given Scope Necessarily Varies. The scoping provision requires identification of those conditions EPA "expects to consider," a clause that would be unnecessary if EPA were directed to simply include "all" conditions of use in a risk evaluation. The future tense also acknowledges that EPA might subsequently change 8 4 TSCA § 6(b)(4)(A). 5 See Massachusetts v. EPA, 549 U.S. 497, 531, 535 (2007) addressing EPA's application of its Chevron deference to particular statutory constructions: EPA not required to regulate "all" greenhouse gases as "air pollutants" everywhere that term appears in the statute; EPA must ground its reasons for action or inaction in the statute; agency regulation cannot conflict with statutory design, and law cannot be read to compel EPA to regulate in a manner contrary to "common sense." 6 82 Fed. Reg. at 7265. 7 TSCA § 6(b)(3)(D). 8 Before LCSA was enacted, EPA had published multiple problem formulations under the TSCA Work Plan. EPA explained that its problem formulations served as a means for explaining the scope of a risk assessment: "A problem formulation and initial assessment document will serve to inform the public and other interested stakeholders about EPA's initial scoping of findings and plan for any further risk assessment. Problem formulation and initial assessment is the analytical phase of the assessment in which the purpose for the assessment is articulated, the problem defined and a plan for analyzing and characterizing risk is determined." Many of those completed problem formulations were for limited conditions of use. Like other aspects of the TSCA Work Plan, Congress 5/Page Source: https://www.industrydocuments.ucsf.edu/docs/kzbn0226 its position with respect to what conditions of use to include or exclude. Notably, this construction affords EPA the discretion to include all conditions of use where necessary. This is consistent with congressional intent. Speaking about the compromise bill that was signed into law, Senator Vitter said that EPA "is given the discretion to determine the conditions of use that the Agency will address in its evaluation of the priority chemical." This discretion and flexibility "assures that the Agency's focus is on conditions of use that raise the greatest potential for risk" particularly given that "many TSCA chemicals have multiple uses - industrial, commercial and consumer uses" and EPA is "well aware that some categories of uses pose greater potential for exposure than others and that the risks from many categories of uses are deemed negligible or already well controlled."9 D. EPA Should Expressly Exclude Substances that Are Not Regulated Under TSCA from the Scope of Risk Evaluations. TSCA excludes a number of chemical categories from its statutory scope. LCSA did not change these; accordingly, these categories should not be considered for inclusion in any risk evaluation undertaken pursuant to Section 6: (i) [a]ny mixture, (ii) any pesticide (as defined in the Federal Insecticide, Fungicide, and Rodenticide Act) when manufactured, processed, or distributed in commerce for use as a pesticide; (iii) tobacco or any tobacco product, (iv) any source material, special nuclear material, or byproduct material (as such terms are defined in the Atomic Energy Act of 1954 and regulations issued under such Act), (v) any article the sale of which is subject to the tax imposed by section 4181 of the Internal Revenue Code of 1986 [i.e., firearms and ammunition] (vi) any food, food additive, drug, cosmetic, or device (as such terms are defined in section 201 of the Federal Food, Drug, and Cosmetic Act) when manufactured, processed, or distributed in commerce for use as a food, food additive, drug, cosmetic, or device. The risk evaluation rule should expressly clarify that because these categories are excluded from the definition of "chemical substance" under TSCA, and they are outside EPA's legislative authority to regulate, they therefore excluded from the scope of risk evaluations under Section 6. contemplated that problem formulations from the TSCA Work Plan would serve as the model for EPA actions under the amended TSCA. In this case, the problem formulations were to be the model for the scoping exercise under Section 6(b)(4)(D). This is a strong indication that Congress authorized EPA to determine which conditions of use it would evaluate in a risk evaluation by defining the scope appropriately. 9 Senate Congressional Record, June 7, 2016, at S3519; available at also clarifies that unreasonable risk/no unreasonable risk determinations made pursuant to the risk evaluation are made use-by-use: "[T]o be clear, every condition of use identified by the Administrator in the scope of the risk evaluation must, and will be either found to present or not present an unreasonable risk." Id. at S3520. 6/Page Source: https://www.industrydocuments.ucsf.edu/docs/kzbn0226 Likewise, the rule should clarify that chemical uses within these exclusions are "conditions of use" that are outside the scope of any Section 6 risk evaluation. In addition to TSCA, which was modernized by the passage of LCSA in 2016, there is a network of statutes in place regulating the safety of chemicals in various venues and applications. Several other federal statutes are in place to regulate chemicals in products and during activities such as workplace manufacturing. Notably, the Consumer Protection Act, Consumer Product Safety Improvement Act, and the Federal Hazardous Substances Act regulate chemicals in a suite of consumer products, including children's products and toys, and the Occupational Safety and Health Act (OSH Act) regulates chemicals in the workplace. Chemicals in uses regulated by other federal laws and agencies are often referred to as "non- TSCA" uses. EPA should not include these uses in its risk evaluations under TSCA. In rare cases where inclusion might be justified, the Agency should establish criteria to justify including non-TSCA uses in its risk evaluations and should articulate the steps it will follow to ensure adequate interagency consultation and review at the scoping stage. We discuss this topic in more detail below. E. EPA Should Generally Exclude OSHA-Regulated Uses from the Scopes of TSCA Risk Evaluations. Although LCSA specifically includes "workers" as a possible category of "potentially exposed or susceptible subpopulation," it does not designate "workers" as a default category. Any consideration of worker exposure must begin with the recognition that worker exposures are regulated under the OSH Act. Given that Occupational Safety and Health Administration (OSHA) standards are in place for the very purpose of regulating risk to worker populations, it should be the unusual case where unreasonable risk may present to a worker population under conditions of use (e.g., use of personal protective equipment). Importantly, although Congress recognizes under LCSA that it may be appropriate, under particular circumstances, for EPA to designate workers as a potentially exposed or susceptible subpopulation under TSCA, and to regulate workplace exposures, Congress did not amend the OSH Act at the same time that it amended TSCA. Congress also left Section 9(d) of TSCA intact. This section requires EPA to consult and coordinate with OSHA "for the purpose of achieving the maximum enforcement of [TSCA] while imposing the least burdens of duplicative requirements on those subject to [TSCA] and for other purposes.' EPA should ensure that this consultation occurs before risk evaluations are scoped; in cases where worker exposures do not present a significant risk of health impairment under current conditions of use, EPA should decline to include worker populations within the scope of the risk assessment as unduly burdensome and duplicative. This process will help focus risk evaluations and reduce the resource cost to the Agency. Following this consultation, if OSHA agrees that EPA-led risk evaluation considering worker exposures is necessary (and not otherwise duplicative), EPA should describe the process it used to consult with OSHA and the basis for its findings in the scope of the risk evaluation. 7/Page Source: https://www.industrydocuments.ucsf.edu/docs/kzbn0226 F. EPA Should Generally Exclude Low Exposure Conditions of Use from the Scopes of TSCA Risk Evaluations. In the prioritization process, certain scenarios may emerge that are low- - to no-exposure. An example is a closed system, intermediate chemical manufacture or processing at an industrial site, where worker exposure is well documented and controlled, and does not present a significant risk. A second example would be de minimis levels of an impurity in a consumer product, where the levels and variability are well documented and well understood, and exposures are so low as not to present a significant risk. In such cases, it should be apparent in the prioritization process or before scoping that these use scenarios can readily be excluded from the scope of the risk evaluation. G. EPA Should Apply the "Reasonably Foreseen" Provision as a Focusing Tool to Help Tailor the Scope of Risk Evaluations - Not to Expand Them. The statutory definition of "conditions of use" is "the circumstances, as determined by the Administrator, under which a chemical substances is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used or disposed of.">10 The phrase "intended, known, or reasonably foreseen" limits the conditions of use that may be identified and included in a scope. Clearly, if a particular use is not intended, known, or reasonably foreseen, it is not a statutory "condition of use" and may not be included within the scope of a risk evaluation. The term "intended" is generally well understood to mean intended by the manufacturer or processor. Intention can be demonstrated through express (e.g., a statement to that effect in a premanufacture notice) or implied evidence (e.g., marketing materials that imply a potential application for the chemical). The term "known" is often considered a backstop for the term "intended," in that manufacturers or processors may not "intend" or support a particular downstream use for a chemical but may have actual or imputed knowledge that a chemical is being used in that application. The definition of "conditions of use" also includes the term "reasonably foreseen." The concept of reasonable foreseeability is well understood in American and western11 tort law. Foreseeability is "the determinant for the limits of duty under a conventional risk analysis" [emphasis added]. Foreseeability is modified by "reasonably," which makes clear that not 12 every conceivable or speculative use is included. Product misuses and illegal uses, and manufacturing that disregards legal and industrial hygiene requirements, are not "reasonable" and thus not "reasonably foreseen." 10 TSCA §3(4). 11 See, e.g., ANNEXURE T, The Concept of Limited Liability, Existing Law and Rationale (Australia), referring to the limiting tests of reasonable foreseeability and proximity, available at htp:/lwww.dpc.nsw.gov.au data/assets/odf.file/0012/11406/T.pdi 12 Tyrus V. Dahl Jr., Strict Products Liability: The Irrelevance of Foreseeability and Related Negligence Concepts, 14 Tulsa L. J. 338, 343 (1978). 8/Page Source: https://www.industrydocuments.ucsf.edu/docs/kzbn0226

What is the abbreviation of The American Chemistry Council?

ylcn0226

ylcn0226_p0, ylcn0226_p1, ylcn0226_p2, ylcn0226_p3, ylcn0226_p4, ylcn0226_p5, ylcn0226_p6, ylcn0226_p7, ylcn0226_p8, ylcn0226_p9

ACC

Search 1/19/17 snapshot Assessing and Managing Chemicals under TSCA Contact Us Share Assessing and Managing Chemicals under The Frank R. Lautenberg TSCA Home Chemical Safety for the How EPA Assesses Chemical Safety 2 1st Century Act Assessments for TSCA Work Plan Chemicals On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for Sign up for Current Chemical the 21st Century Act which amends the Toxic TSCA and Risk Reduction Activities Other Substances Control Act (ISCA), the Nation's Chemical ChemView primary chemicals management law. Safety News Chemical Data Reporting The new law, which received bipartisan support in both the U.S. House of Representatives and Getemail alerts the Senate, includes much needed improvements such as: Enter email address sign up Mandatory requirement for EPA to evaluate existing chemicals with clear and enforceable deadlines; New risk-based safety standard; Increased public transparency for chemical information; and Recent Consistent source of funding for EPA to carry additions out the responsibilities under the new law. Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 American" Chemistry Council August 24, 2016 Wendy Cleland-Hamnett Director, Office of Pollution Prevention and Toxics Environmental Protection Agency 1200 Pennsylvania Ave. NW Washington, DC 20460-0001 Sent electronically to www.regulations.gov docket # EPA-HQ-OPPT-2016-0400 Re: ACC Comments to Inform EPA's Rulemaking on the Conduct of Risk Evaluations under the Lautenberg Chemical Safety Act Dear Ms. Cleland-Hamnett: The American Chemistry Council (ACC¹ appreciates the opportunity to provide input to the Office of Pollution Prevention and Toxics to inform the Agency's development of a risk evaluation rulemaking under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (LCSA). ACC has a long-standing commitment to a robust, science-based approach to evaluation of human and environmental risk. ACC is committed to the effective implementation of the LCSA and supports a workable, rigorous process that allows for timely, high quality reviews. Given the strong emphasis on a risk-based approach in the LCSA, the Section 6(b)(4) rulemaking is particularly important because it will guide the conduct of future risk evaluations that will then inform risk management activities. ACC is committed to being a constructive stakeholder throughout the implementation of LCSA. We will continue to draw from the breadth and depth of our member companies' expertise to ensure that our recommendations are not only science-based, but also allow for the efficient and effective implementation of the LCSA. In doing so, ACC will continue to consider the high quality science standards in the LCSA as well as the timeframes and deadlines imposed therein. The enclosed recommendations were developed with these important considerations in mind. If EPA has any questions, please contact me at nancy [email protected] or 202-249-6417. Sincerely, Nancy B. Beck, PhD, DABT Senior Director, Regulatory and Technical Affairs Cc: Jim Jones, OCSPP Assistant Administrator Louise Wise, Deputy Assistant Administrator Jeffery Morris, Deputy Director for Programs, OPPT Tala Henry, Director, Risk Assessment Division, OPPT 1 The American Chemistry Council (ACC) represents the leading companies engaged in the business of chemistry. More information about ACC is presented in the body of our comments. 1 IPage Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 American Chemistry Council Initial Input to U.S. Environmental Protection Agency In Regard to the Risk Evaluation Rule under the Lautenberg Chemical Safety Act Table of Contents I. Introduction and Executive Summary 4 II. The Risk Evaluation Rulemaking Must Include both Procedural And Substantive Elements to Effect the Purposes of the Statute 5 III. The Proposed Rule Should Include a Tiered Approach to Risk Evaluation 6 IV. The Rule Should Clarify the Process for Preparation and Contents of the Scope 8 V. The Proposed Rule Should Include a Detailed Description of Substantive Elements of Risk Evaluation 8 VI. Proposed Rule Should Ensure Consistency with Section 6(b)(4)(F) 9 a. Integration and Assessment of Information Relevant to Risks and Information on Potentially Exposed and Susceptible Populations 10 i. Conditions of Use That are Relevant 10 ii. Potentially Exposed or Susceptible Subpopulations 10 b. Aggregate and Sentinel Exposures 12 i. Aggregate Exposures 12 ii. Sentinel Exposures 12 c. Exposure Assessment 13 d. Weight of the Evidence 14 VII. The Proposed Rule Should Incorporate Section 26(h) Scientific Standards 14 a. Fit-for-Purpose Approach 15 b. Consideration of Relevant Information 16 i. Improving Hazard Assessment 16 ii. Improving Dose Response Assessment 17 iii. Reliance on Guidance 17 c. Importance of High Quality Risk Characterization 18 d. Clearly Addressing Variability and Uncertainty 18 e. Ensuring Appropriate Peer Review and Forming a Science Advisory Committee on Chemicals 19 21 Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 VIII. The Proposed Rule Should Implement a Weight of the Scientific Evidence (WoE) Approach 20 a. Systematic Review is Required 20 i. Development of a Protocol 21 ii. Search Strategy 21 iii. Transparency 21 b. A Systematic Review is Not Automatically a WoE Assessment 21 c. WoE and Systematic Review for Screening Level Risk Evaluations 22 d. WoE and Systematic Review for Refined Risk Evaluations 22 e. Strength of Evidence is Not the Same as WoE 23 IX. EPA Should Make Information Available Consistent with Section 26(j) 24 X. EPA Should Use Reasonably Available Information and CBI Consistent with Section 26(k) 24 XI. EPA Should Utilize Fit-for-Purpose Exposure Evaluation Tools 25 XII. The Requirements of Sections 6 and 26 Apply to Environmental Risk Evaluations 26 a. Advancing Models for Environmental Risks 27 b. Improving Data Sourcing, Generation, and Evaluation 27 c. Persistent, Bioaccumulative and Toxic (PBT) Substances 28 XIII. EPA Should Leverage International and Inter-Agency Cooperation 28 XIV. Incorporating High Throughput Tools and Alternative Methods 29 XV. Stakeholders and EPA Must Be Held to the Same High Standard 30 APPENDIX A: ACC's Principles for Improving Chemical Hazard and Risk Assessment 31 APPENDIX B: Improving Hazard Assessment 32 APPENDIX C: Improving Does Response Assessment 33 APPRNDIX D: Improving Risk Characterization 35 APPENDIX E: Ensuring Robust Peer Review 37 APPENDIX F: Exposure Modeling Tools 39 APPENDIX G: Additional Information on the ECETOC TRA 41 3 I P a 3 e Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 I. Introduction and Executive Summary The American Chemistry Council (ACC)2 is pleased to provide the U.S. Environmental Protection Agency (EPA) this initial input on the Lautenberg Chemical Safety Act's (LCSA) requirement for the Agency to establish, by rule, the process for conducting risk evaluations. ACC appreciates EPA's early efforts to obtain input from stakeholders at its August 9, 2016, public meeting. We also appreciate EPA's solicitation of written comments to be entered into the docket, well in advance of publication of the proposed rule. Our comments both clarify, as well as supplement and expand upon, the oral comments we presented at the August 9 meeting. ACC strongly supported Congress' efforts to update and reform the Toxic Substances Control Act (TSCA). We believe that high quality risk evaluation, using best available science and weight of the evidence (WoE), is at the very heart of the LCSA. Effective and efficient risk evaluations will help deliver the results intended by Congress. Section 6(b)(4)(B) of the statute requires EPA to establish, by rule, "a process to conduct risk evaluations.' This certainly should include a description of the sequence of events, timelines, opportunities for public comments and peer review. Both Sections 6 and 26 of the LCSA outline various substantive elements that apply to and inform risk evaluation. A risk evaluation must: Be conducted in a manner designed to determine "whether a chemical substance presents an unreasonable risk of injury to health or the environment;" as set out in Section 6(b)(4)(A); Identify whether there exists "an unreasonable risk to a potentially exposed or susceptible subpopulation." EPA must identify potentially exposed or susceptible subpopulations relevant to the risk evaluation under conditions of use; Address the specific elements set out in Section 6(b)(4)(F); and Comply with the specific requirements of Section 26, including the best available science, weight of the evidence, and transparency requirements. Because these elements are at the core of the risk evaluation process, and affect risk management measures, they are substantive and should be described in adequate detail in the regulation. In general, where risk evaluation elements are now required by statute, EPA should apply them uniformly and universally reflecting them in the body of the regulation. The recommendations provided by ACC in these comments address screening and refined risk evaluations and are meant to apply to both human health and environmental risks. Specific tools, testing methods, databases, and the like may develop over time, or course, and can be updated as necessary in policies, 2 The American Chemistry Council (ACC) represents the leading companies engaged in the business of chemistry. ACC members apply the science of chemistry to make innovative products and services that make people's lives better, healthier and safer. ACC is committed to improved environmental, health and safety performance through Responsible Care common sense advocacy designed to address major public policy issues, and health and environmental research and product testing. The business of chemistry is a $797 billion enterprise and a key element of the nation's economy. It is the nation's largest exporter, accounting for fourteen percent of all U.S. exports. Chemistry companies are among the largest investors in research and development. Safety and security have always been primary concerns of ACC members, and they have intensified their efforts, working closely with government agencies to improve security and to defend against any threat to the nation's critical infrastructure. 4 Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 procedures and guidance. Our comments strive to make these differentiations and explain where particular elements of risk evaluation should be included in the rule proper. Specifically, our recommendations suggest definitions, and procedural steps and elements that will allow EPA to ensure that risk evaluations are consistent with the statutory requirements for EPA to use the best available science and WoE approaches. The recommendations also include definitions and procedural steps are not expected to change over time. ACC has referenced each of our suggestions to an existing EPA guidance, a National Academies (NAS) report, or another authoritative body or peer reviewed report. For instance, the recommendations in EPA's 2000 Risk Characterization Handbook still represent best practices today. Adding adequate definitions and explanation to the rule is particularly important to achieving incorporation of statutory requirements. We also note that in addition to Section 6, Sections 26(h), 26(i), 26(j), and 26(k) of the LCSA each present legal requirements that are applicable to the risk evaluation. EPA will now need to provide a level of transparency regarding not only the inputs, but also the methods of the analysis, including clear descriptions of uncertainties and variability. EPA should leverage information from other jurisdictions where data and information is applicable and of sufficient quality to meet the science standards in the LCSA. Incorporating these elements into the rulemaking creates a better platform for clear and consistent articulation of the Agency's understanding of statutory requirements, and will better support consistent and uniform application of the elements of risk evaluation. It is critically important that EPA engage the public as EPA plans, scopes, and conducts risk evaluations. Industry scientists often have unique insight and experience with their companies' chemistries and collectively have a large body of knowledge of risk assessment processes globally, including an understanding of potential human health and environmental impacts. ACC encourages EPA to leverage this knowledge and engage early (well before draft risk evaluations are released) and frequently with industry throughout the risk evaluation process. II. The Risk Evaluation Rulemaking Must Include both Procedural and Substantive Elements to Effect the Purposes of the Statute Congress included a specific mandate to EPA to establish a risk evaluation rulemaking. There is little question that the rule must describe the process by which risk evaluations will be conducted. However, to 3 effect the purposes of the statute, the process described in the rule cannot merely set out timelines or the sequence of the risk evaluation. It must include a clear articulation of the substantive elements of risk evaluation, and more particularly, it must explain how it will apply the principles set out in Section 6(b)(4)(F), Section 26, and other parts of the statute. If Congress had intended the scientific standard of "best available science" or "weight of the scientific evidence" to be incorporated into guidance alone, it would have included them only in Section 26(1) on "policies, procedures and guidance." 3 "[T]he Administrator shall establish, by rule, a process to conduct risk evaluations in accordance with subparagraph (A) " Section 6(b)(4)(A). 5 I Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 The very purpose of the risk evaluation is to develop the evidentiary and scientific basis to enable EPA to complete the risk determination required by statute. That risk determination has substantive impact - it significantly affects conduct, activity or a substantive interest that is the subject of agency regulation. The determination following risk evaluation is a necessary prerequisite for a chemical to proceed to risk management, if warranted. The rule should thus include a clear description of how EPA will undertake risk evaluations in order to meet the new statutory requirements of the LCSA. This includes a description of the scoping process and requirements for a published scope as well as the elements of the risk evaluation itself and the mechanism for gauging adequacy as measured against statutory criteria. III. The Proposed Rule Should Include a Tiered Approach to Risk Evaluation We believe the statute contemplates a tiered approach to risk evaluation and recommend that EPA include a tiered approach in the rule. Under the LCSA, EPA must initiate the risk evaluation "upon designating" a chemical as a high-priority substance. The scope, however, is not required to be published "upon initiation" -- EPA has up to six months following the initiation of the risk evaluation to prepare and publish the scope. Congress intended this six month period to be used for a scoping exercise, where EPA identifies "the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations the Administrator expects to consider in the risk evaluation." This six month period is a "step" between the high priority designation and the publication of the scope. In order for EPA to conduct risk evaluations consistent with the quality required by the LCSA and within the timeframes required, EPA should conduct a screening level evaluation during the scoping phase. During the scoping phase of risk evaluations, tools exist to allow EPA to conduct quantitative screening level analyses of multiple exposure scenarios, as appropriate for consumers, sensitive subpopulations, and the environment. This will allow EPA to have a more tailored focus on those populations and exposures of greatest concern during a refined risk evaluation process. Figure 1 below depicts ACC's recommended approach. 6 I Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 - y 10 Worknlan High-Duality Refined Risk Evaluation High Pricrity Chemicats & DRAFT Chemicals Manufacturer Risk Evaluation Requested EXPOSSURES HAZARD Evaluation incorporating Sections 6 and 26 of the Lautenberg Chemicel Safety Act (LCSA): Scope/Screening Level Risk Evatuation Scientific Standards FINAL Susceprible Weight of Scientific Evidence Evaluations Risk Evaluation Exposures Pupulations or use Certain Conditions of Use Present Do not present an anreasonable risk an unreasonable risk Refined No further risk evaluation risk avaluation No further action; needed RUREMAKING PROCESS COMPLETE the Figure 1. A Two-Step Process for Conducting Risk Evaluations Note: This is a simplified version of the process. A tiered approach, where EPA uses the scoping step (step 1) to conduct a quantitative screening level analysis, will allow EPA to focus its limited resources on more robust refined risk evaluations for only those conditions of use where unreasonable risks cannot be ruled out. Screening-level assessments require less data and information, and are typically deterministic and based on conservative, health protective assumptions and methods. When a screening assessment indicates low risk for a particular condition of use, the Agency should have a high degree of confidence that the potential risks are much lower than the calculation and, therefore, the actual risks are lower and/or perhaps non-existent. However, when a screening-level risk assessment indicates a potential concern for an adverse effect, this does not mean that the actual risks are significant and warrant action. Rather, it indicates the Agency should take a second step in the risk evaluation process to refine the evaluation to more accurately quantify potential risks. The refined risk evaluation (step 2) will require realistic and representative data, higher tier modeling approaches, including probabilistic exposure modeling, and a more comprehensive consideration of human relevance and dose-response relationships. In a refined evaluation, EPA should also consider targeted exposure studies, as well as biomonitoring and environmental monitoring data, to the extent that this information is available and relevant. This approach is consistent with EPA's 2014 Framework for Human Health Risk Assessment to Inform Decision Making (HHRA Framework)4. which also emphasizes the importance of a fit-for-purpose approach to risk evaluation. This approach is also consistent with EPA's exposure assessment guidelines and practices. The concept of a tiered approach and a fit-for-purpose 5 evaluation are woven throughout ACC's recommendations. 4 See tps://www.epa.gov/sites/production/files/2014-12/documents/hhra-framework-final-2014.pdf. 5 See: tps://www.epa.gov/expobox/exposure-assessment-tools-tiers-and-types-screening-level-and-refined. 7 Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 The tiered approach ACC recommends is consistent with the approach EPA took in the problem formulation and initial assessment document for tetrabromobisphenol A (TBBPA.6 In that document, EPA conducted an initial screening level evaluation to support its conceptual model and analysis plan. EPA appropriately used high-end exposure values coupled with the lowest toxicity values to evaluate uses and exposure pathways of potential concern. While EPA did not share the relevant risk evaluation calculations in its public document, the general approach is consistent with that of a screening level risk evaluation. ACC encourages EPA to continue with this approach and to transparently and clearly present quantitative screening level analyses for the conditions of use and exposure scenarios that are part of the conceptual model EPA develops as part of the scoping phase. IV. The Rule Should Clarify the Process for Preparation and Contents of the Scope As noted above, Congress allowed a six month period for preparation of the scope of the risk evaluation, contemplating that time and effort would be needed to move from prioritization to a published scope. The six month period is to enable EPA to identify "the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations the Administrator expects to consider in the risk evaluation." Two things are evident from this language and the time frame afforded: 1) EPA should use this period to evaluate and decide which, if any, potentially exposed or susceptible subpopulations should be included in the risk evaluation (in other words, it need not include all such subpopulations, regardless of size, impact, or relevance); and 2) tEPA has flexibility to actually conduct a full risk evaluation of some or all the potential scenarios set out in the scope. In short, EPA need not include every conceivable condition of use in a risk evaluation. This view is further buttressed by the definition of "conditions of use" in Section 3 of the LCSA, which points to the need for EPA to determine the relevant conditions of use: "the circumstances, as determined by the Administrator, under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of." (Emphasis added). V. The Proposed Rule Should Include a Detailed Description of Substantive Elements of Risk Evaluation The term, "risk evaluation" is not expressly defined in the LCSA. While the term "risk assessment" has been widely used in EPA programs and operationally has clear meaning derived from years of guidance, policies and practices, that term was not used in the statute. Therefore even though it may be reasonable to assume "risk evaluation" may fully equate with the term "risk assessment," given the context of its use (integrating hazard with exposure) in the LCSA, EPA is encouraged to explicitly define and operationalize this term as part of its rulemaking. The term will not have clear meaning until an interpretation is assigned by EPA. We believe the essential elements of a Section 6 and 26 risk evaluation must be articulated in a clear regulatory definition as we discuss below. 6 EPA, Problem Formulation and Initial Assessment Tetrabromobisphenol A and Related Chemicals Cluster Flame Retardants, 2015, available at: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/tsca-work-plan-chemical-problem- formulation-and-2. 8 IPage Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 Section 6(b)(4)(B) of the statute requires EPA to establish, by rule, "a process to conduct risk evaluations." This process is itself required to meet a number of substantive elements described in the LCSA; a risk evaluation must: Be conducted in a manner designed to help the agency determine "whether a chemical substance presents an unreasonable risk of injury to health or the environment;" as set out in Section 6(b)(4)(A). Include consideration of "an unreasonable risk to a potentially exposed or susceptible subpopulation." EPA must identify relevant potentially exposed or susceptible subpopulations relevant to the risk evaluation under conditions of use; Address the specific elements set out in Section 6(b)(4)(F); and Comply with the specific requirements of Section 26, including the best available science, weight of the evidence, and transparency requirements. The very purpose of the risk evaluation is to develop the evidentiary and scientific basis to enable EPA to complete the risk determination required by statute. That risk determination has substantive impact - it significantly affects conduct, activity or a substantive interest that is the subject of agency regulation. The basis for the risk determination thus should be adequately described in the rule itself to offer sufficient notice to the regulated community. This is particularly important for decisions that inform safety and safety determinations. Likewise, decisions that have broad reaching impact should be supported in regulations, not merely through guidance or agency policy. 8 While EPA cannot substitute policy or guidance for a regulatory description of what will constitute a complete and robust risk evaluation, we believe the necessary elements can be developed in this rulemaking in a timely manner. VI. The Proposed Rule Should Ensure Consistency with Section 6(b)(4)(F) As discussed below, Section 6(b)(4)(F) of the LCSA describes five requirements for risk evaluations that shall be considered by the Administrator and must be incorporated into the risk evaluation rulemaking. 7 See, e.g., MST Express v. U.S. Department of Transportation, 108 F.3d 401 (D.C. Cir. 1997). DOT was directed under the Motor Carrier Safety Act (MCSA) to "prescribe regulations establishing a procedure to decide on the safety fitness of owners and operators of commercial motor vehicles." [Emphasis added]. The MCSA stated that implementing regulations would include "a means of deciding whether the owners, operators, and persons meet the safety fitness requirements." DOT promulgated regulations that set out a process for decision making but used guidance to articulate the tests by which the agency would determine whether vehicles met the safety fitness requirements. The court rejected DOT's reliance on guidance because it "failed to carry out its statutory obligation to establish by regulation a means of determining whether a carrier has complied with the safety fitness requirements." 8 As a general matter, "...it seems to be established that "regulations,' 'substantive rules' or 'legislative rules' are those which create law, usually implementary to an existing law." Gibson Wine Co. v. Snyder, 194 F.2d 329, 331 (D.C. Cir. 1952), cited by Brown Express, Inc. v. U.S., 607 F.2d 695, 700 (5th Cir. 1979). A "rule" is defined under Section 2 of the Administrative Procedure Act, in relevant part, as: "the whole or part of an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy or describing the organization, procedure, or practice requirements of an agency." 5 U.S.C. § 551(4). 9 I Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226

ACC strongly supported Congress' effort for which act?

ylcn0226

ylcn0226_p0, ylcn0226_p1, ylcn0226_p2, ylcn0226_p3, ylcn0226_p4, ylcn0226_p5, ylcn0226_p6, ylcn0226_p7, ylcn0226_p8, ylcn0226_p9

Toxic Substances Control Act

Search 1/19/17 snapshot Assessing and Managing Chemicals under TSCA Contact Us Share Assessing and Managing Chemicals under The Frank R. Lautenberg TSCA Home Chemical Safety for the How EPA Assesses Chemical Safety 2 1st Century Act Assessments for TSCA Work Plan Chemicals On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for Sign up for Current Chemical the 21st Century Act which amends the Toxic TSCA and Risk Reduction Activities Other Substances Control Act (ISCA), the Nation's Chemical ChemView primary chemicals management law. Safety News Chemical Data Reporting The new law, which received bipartisan support in both the U.S. House of Representatives and Getemail alerts the Senate, includes much needed improvements such as: Enter email address sign up Mandatory requirement for EPA to evaluate existing chemicals with clear and enforceable deadlines; New risk-based safety standard; Increased public transparency for chemical information; and Recent Consistent source of funding for EPA to carry additions out the responsibilities under the new law. Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 American" Chemistry Council August 24, 2016 Wendy Cleland-Hamnett Director, Office of Pollution Prevention and Toxics Environmental Protection Agency 1200 Pennsylvania Ave. NW Washington, DC 20460-0001 Sent electronically to www.regulations.gov docket # EPA-HQ-OPPT-2016-0400 Re: ACC Comments to Inform EPA's Rulemaking on the Conduct of Risk Evaluations under the Lautenberg Chemical Safety Act Dear Ms. Cleland-Hamnett: The American Chemistry Council (ACC¹ appreciates the opportunity to provide input to the Office of Pollution Prevention and Toxics to inform the Agency's development of a risk evaluation rulemaking under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (LCSA). ACC has a long-standing commitment to a robust, science-based approach to evaluation of human and environmental risk. ACC is committed to the effective implementation of the LCSA and supports a workable, rigorous process that allows for timely, high quality reviews. Given the strong emphasis on a risk-based approach in the LCSA, the Section 6(b)(4) rulemaking is particularly important because it will guide the conduct of future risk evaluations that will then inform risk management activities. ACC is committed to being a constructive stakeholder throughout the implementation of LCSA. We will continue to draw from the breadth and depth of our member companies' expertise to ensure that our recommendations are not only science-based, but also allow for the efficient and effective implementation of the LCSA. In doing so, ACC will continue to consider the high quality science standards in the LCSA as well as the timeframes and deadlines imposed therein. The enclosed recommendations were developed with these important considerations in mind. If EPA has any questions, please contact me at nancy [email protected] or 202-249-6417. Sincerely, Nancy B. Beck, PhD, DABT Senior Director, Regulatory and Technical Affairs Cc: Jim Jones, OCSPP Assistant Administrator Louise Wise, Deputy Assistant Administrator Jeffery Morris, Deputy Director for Programs, OPPT Tala Henry, Director, Risk Assessment Division, OPPT 1 The American Chemistry Council (ACC) represents the leading companies engaged in the business of chemistry. More information about ACC is presented in the body of our comments. 1 IPage Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 American Chemistry Council Initial Input to U.S. Environmental Protection Agency In Regard to the Risk Evaluation Rule under the Lautenberg Chemical Safety Act Table of Contents I. Introduction and Executive Summary 4 II. The Risk Evaluation Rulemaking Must Include both Procedural And Substantive Elements to Effect the Purposes of the Statute 5 III. The Proposed Rule Should Include a Tiered Approach to Risk Evaluation 6 IV. The Rule Should Clarify the Process for Preparation and Contents of the Scope 8 V. The Proposed Rule Should Include a Detailed Description of Substantive Elements of Risk Evaluation 8 VI. Proposed Rule Should Ensure Consistency with Section 6(b)(4)(F) 9 a. Integration and Assessment of Information Relevant to Risks and Information on Potentially Exposed and Susceptible Populations 10 i. Conditions of Use That are Relevant 10 ii. Potentially Exposed or Susceptible Subpopulations 10 b. Aggregate and Sentinel Exposures 12 i. Aggregate Exposures 12 ii. Sentinel Exposures 12 c. Exposure Assessment 13 d. Weight of the Evidence 14 VII. The Proposed Rule Should Incorporate Section 26(h) Scientific Standards 14 a. Fit-for-Purpose Approach 15 b. Consideration of Relevant Information 16 i. Improving Hazard Assessment 16 ii. Improving Dose Response Assessment 17 iii. Reliance on Guidance 17 c. Importance of High Quality Risk Characterization 18 d. Clearly Addressing Variability and Uncertainty 18 e. Ensuring Appropriate Peer Review and Forming a Science Advisory Committee on Chemicals 19 21 Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 VIII. The Proposed Rule Should Implement a Weight of the Scientific Evidence (WoE) Approach 20 a. Systematic Review is Required 20 i. Development of a Protocol 21 ii. Search Strategy 21 iii. Transparency 21 b. A Systematic Review is Not Automatically a WoE Assessment 21 c. WoE and Systematic Review for Screening Level Risk Evaluations 22 d. WoE and Systematic Review for Refined Risk Evaluations 22 e. Strength of Evidence is Not the Same as WoE 23 IX. EPA Should Make Information Available Consistent with Section 26(j) 24 X. EPA Should Use Reasonably Available Information and CBI Consistent with Section 26(k) 24 XI. EPA Should Utilize Fit-for-Purpose Exposure Evaluation Tools 25 XII. The Requirements of Sections 6 and 26 Apply to Environmental Risk Evaluations 26 a. Advancing Models for Environmental Risks 27 b. Improving Data Sourcing, Generation, and Evaluation 27 c. Persistent, Bioaccumulative and Toxic (PBT) Substances 28 XIII. EPA Should Leverage International and Inter-Agency Cooperation 28 XIV. Incorporating High Throughput Tools and Alternative Methods 29 XV. Stakeholders and EPA Must Be Held to the Same High Standard 30 APPENDIX A: ACC's Principles for Improving Chemical Hazard and Risk Assessment 31 APPENDIX B: Improving Hazard Assessment 32 APPENDIX C: Improving Does Response Assessment 33 APPRNDIX D: Improving Risk Characterization 35 APPENDIX E: Ensuring Robust Peer Review 37 APPENDIX F: Exposure Modeling Tools 39 APPENDIX G: Additional Information on the ECETOC TRA 41 3 I P a 3 e Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 I. Introduction and Executive Summary The American Chemistry Council (ACC)2 is pleased to provide the U.S. Environmental Protection Agency (EPA) this initial input on the Lautenberg Chemical Safety Act's (LCSA) requirement for the Agency to establish, by rule, the process for conducting risk evaluations. ACC appreciates EPA's early efforts to obtain input from stakeholders at its August 9, 2016, public meeting. We also appreciate EPA's solicitation of written comments to be entered into the docket, well in advance of publication of the proposed rule. Our comments both clarify, as well as supplement and expand upon, the oral comments we presented at the August 9 meeting. ACC strongly supported Congress' efforts to update and reform the Toxic Substances Control Act (TSCA). We believe that high quality risk evaluation, using best available science and weight of the evidence (WoE), is at the very heart of the LCSA. Effective and efficient risk evaluations will help deliver the results intended by Congress. Section 6(b)(4)(B) of the statute requires EPA to establish, by rule, "a process to conduct risk evaluations.' This certainly should include a description of the sequence of events, timelines, opportunities for public comments and peer review. Both Sections 6 and 26 of the LCSA outline various substantive elements that apply to and inform risk evaluation. A risk evaluation must: Be conducted in a manner designed to determine "whether a chemical substance presents an unreasonable risk of injury to health or the environment;" as set out in Section 6(b)(4)(A); Identify whether there exists "an unreasonable risk to a potentially exposed or susceptible subpopulation." EPA must identify potentially exposed or susceptible subpopulations relevant to the risk evaluation under conditions of use; Address the specific elements set out in Section 6(b)(4)(F); and Comply with the specific requirements of Section 26, including the best available science, weight of the evidence, and transparency requirements. Because these elements are at the core of the risk evaluation process, and affect risk management measures, they are substantive and should be described in adequate detail in the regulation. In general, where risk evaluation elements are now required by statute, EPA should apply them uniformly and universally reflecting them in the body of the regulation. The recommendations provided by ACC in these comments address screening and refined risk evaluations and are meant to apply to both human health and environmental risks. Specific tools, testing methods, databases, and the like may develop over time, or course, and can be updated as necessary in policies, 2 The American Chemistry Council (ACC) represents the leading companies engaged in the business of chemistry. ACC members apply the science of chemistry to make innovative products and services that make people's lives better, healthier and safer. ACC is committed to improved environmental, health and safety performance through Responsible Care common sense advocacy designed to address major public policy issues, and health and environmental research and product testing. The business of chemistry is a $797 billion enterprise and a key element of the nation's economy. It is the nation's largest exporter, accounting for fourteen percent of all U.S. exports. Chemistry companies are among the largest investors in research and development. Safety and security have always been primary concerns of ACC members, and they have intensified their efforts, working closely with government agencies to improve security and to defend against any threat to the nation's critical infrastructure. 4 Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 procedures and guidance. Our comments strive to make these differentiations and explain where particular elements of risk evaluation should be included in the rule proper. Specifically, our recommendations suggest definitions, and procedural steps and elements that will allow EPA to ensure that risk evaluations are consistent with the statutory requirements for EPA to use the best available science and WoE approaches. The recommendations also include definitions and procedural steps are not expected to change over time. ACC has referenced each of our suggestions to an existing EPA guidance, a National Academies (NAS) report, or another authoritative body or peer reviewed report. For instance, the recommendations in EPA's 2000 Risk Characterization Handbook still represent best practices today. Adding adequate definitions and explanation to the rule is particularly important to achieving incorporation of statutory requirements. We also note that in addition to Section 6, Sections 26(h), 26(i), 26(j), and 26(k) of the LCSA each present legal requirements that are applicable to the risk evaluation. EPA will now need to provide a level of transparency regarding not only the inputs, but also the methods of the analysis, including clear descriptions of uncertainties and variability. EPA should leverage information from other jurisdictions where data and information is applicable and of sufficient quality to meet the science standards in the LCSA. Incorporating these elements into the rulemaking creates a better platform for clear and consistent articulation of the Agency's understanding of statutory requirements, and will better support consistent and uniform application of the elements of risk evaluation. It is critically important that EPA engage the public as EPA plans, scopes, and conducts risk evaluations. Industry scientists often have unique insight and experience with their companies' chemistries and collectively have a large body of knowledge of risk assessment processes globally, including an understanding of potential human health and environmental impacts. ACC encourages EPA to leverage this knowledge and engage early (well before draft risk evaluations are released) and frequently with industry throughout the risk evaluation process. II. The Risk Evaluation Rulemaking Must Include both Procedural and Substantive Elements to Effect the Purposes of the Statute Congress included a specific mandate to EPA to establish a risk evaluation rulemaking. There is little question that the rule must describe the process by which risk evaluations will be conducted. However, to 3 effect the purposes of the statute, the process described in the rule cannot merely set out timelines or the sequence of the risk evaluation. It must include a clear articulation of the substantive elements of risk evaluation, and more particularly, it must explain how it will apply the principles set out in Section 6(b)(4)(F), Section 26, and other parts of the statute. If Congress had intended the scientific standard of "best available science" or "weight of the scientific evidence" to be incorporated into guidance alone, it would have included them only in Section 26(1) on "policies, procedures and guidance." 3 "[T]he Administrator shall establish, by rule, a process to conduct risk evaluations in accordance with subparagraph (A) " Section 6(b)(4)(A). 5 I Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 The very purpose of the risk evaluation is to develop the evidentiary and scientific basis to enable EPA to complete the risk determination required by statute. That risk determination has substantive impact - it significantly affects conduct, activity or a substantive interest that is the subject of agency regulation. The determination following risk evaluation is a necessary prerequisite for a chemical to proceed to risk management, if warranted. The rule should thus include a clear description of how EPA will undertake risk evaluations in order to meet the new statutory requirements of the LCSA. This includes a description of the scoping process and requirements for a published scope as well as the elements of the risk evaluation itself and the mechanism for gauging adequacy as measured against statutory criteria. III. The Proposed Rule Should Include a Tiered Approach to Risk Evaluation We believe the statute contemplates a tiered approach to risk evaluation and recommend that EPA include a tiered approach in the rule. Under the LCSA, EPA must initiate the risk evaluation "upon designating" a chemical as a high-priority substance. The scope, however, is not required to be published "upon initiation" -- EPA has up to six months following the initiation of the risk evaluation to prepare and publish the scope. Congress intended this six month period to be used for a scoping exercise, where EPA identifies "the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations the Administrator expects to consider in the risk evaluation." This six month period is a "step" between the high priority designation and the publication of the scope. In order for EPA to conduct risk evaluations consistent with the quality required by the LCSA and within the timeframes required, EPA should conduct a screening level evaluation during the scoping phase. During the scoping phase of risk evaluations, tools exist to allow EPA to conduct quantitative screening level analyses of multiple exposure scenarios, as appropriate for consumers, sensitive subpopulations, and the environment. This will allow EPA to have a more tailored focus on those populations and exposures of greatest concern during a refined risk evaluation process. Figure 1 below depicts ACC's recommended approach. 6 I Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 - y 10 Worknlan High-Duality Refined Risk Evaluation High Pricrity Chemicats & DRAFT Chemicals Manufacturer Risk Evaluation Requested EXPOSSURES HAZARD Evaluation incorporating Sections 6 and 26 of the Lautenberg Chemicel Safety Act (LCSA): Scope/Screening Level Risk Evatuation Scientific Standards FINAL Susceprible Weight of Scientific Evidence Evaluations Risk Evaluation Exposures Pupulations or use Certain Conditions of Use Present Do not present an anreasonable risk an unreasonable risk Refined No further risk evaluation risk avaluation No further action; needed RUREMAKING PROCESS COMPLETE the Figure 1. A Two-Step Process for Conducting Risk Evaluations Note: This is a simplified version of the process. A tiered approach, where EPA uses the scoping step (step 1) to conduct a quantitative screening level analysis, will allow EPA to focus its limited resources on more robust refined risk evaluations for only those conditions of use where unreasonable risks cannot be ruled out. Screening-level assessments require less data and information, and are typically deterministic and based on conservative, health protective assumptions and methods. When a screening assessment indicates low risk for a particular condition of use, the Agency should have a high degree of confidence that the potential risks are much lower than the calculation and, therefore, the actual risks are lower and/or perhaps non-existent. However, when a screening-level risk assessment indicates a potential concern for an adverse effect, this does not mean that the actual risks are significant and warrant action. Rather, it indicates the Agency should take a second step in the risk evaluation process to refine the evaluation to more accurately quantify potential risks. The refined risk evaluation (step 2) will require realistic and representative data, higher tier modeling approaches, including probabilistic exposure modeling, and a more comprehensive consideration of human relevance and dose-response relationships. In a refined evaluation, EPA should also consider targeted exposure studies, as well as biomonitoring and environmental monitoring data, to the extent that this information is available and relevant. This approach is consistent with EPA's 2014 Framework for Human Health Risk Assessment to Inform Decision Making (HHRA Framework)4. which also emphasizes the importance of a fit-for-purpose approach to risk evaluation. This approach is also consistent with EPA's exposure assessment guidelines and practices. The concept of a tiered approach and a fit-for-purpose 5 evaluation are woven throughout ACC's recommendations. 4 See tps://www.epa.gov/sites/production/files/2014-12/documents/hhra-framework-final-2014.pdf. 5 See: tps://www.epa.gov/expobox/exposure-assessment-tools-tiers-and-types-screening-level-and-refined. 7 Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 The tiered approach ACC recommends is consistent with the approach EPA took in the problem formulation and initial assessment document for tetrabromobisphenol A (TBBPA.6 In that document, EPA conducted an initial screening level evaluation to support its conceptual model and analysis plan. EPA appropriately used high-end exposure values coupled with the lowest toxicity values to evaluate uses and exposure pathways of potential concern. While EPA did not share the relevant risk evaluation calculations in its public document, the general approach is consistent with that of a screening level risk evaluation. ACC encourages EPA to continue with this approach and to transparently and clearly present quantitative screening level analyses for the conditions of use and exposure scenarios that are part of the conceptual model EPA develops as part of the scoping phase. IV. The Rule Should Clarify the Process for Preparation and Contents of the Scope As noted above, Congress allowed a six month period for preparation of the scope of the risk evaluation, contemplating that time and effort would be needed to move from prioritization to a published scope. The six month period is to enable EPA to identify "the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations the Administrator expects to consider in the risk evaluation." Two things are evident from this language and the time frame afforded: 1) EPA should use this period to evaluate and decide which, if any, potentially exposed or susceptible subpopulations should be included in the risk evaluation (in other words, it need not include all such subpopulations, regardless of size, impact, or relevance); and 2) tEPA has flexibility to actually conduct a full risk evaluation of some or all the potential scenarios set out in the scope. In short, EPA need not include every conceivable condition of use in a risk evaluation. This view is further buttressed by the definition of "conditions of use" in Section 3 of the LCSA, which points to the need for EPA to determine the relevant conditions of use: "the circumstances, as determined by the Administrator, under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of." (Emphasis added). V. The Proposed Rule Should Include a Detailed Description of Substantive Elements of Risk Evaluation The term, "risk evaluation" is not expressly defined in the LCSA. While the term "risk assessment" has been widely used in EPA programs and operationally has clear meaning derived from years of guidance, policies and practices, that term was not used in the statute. Therefore even though it may be reasonable to assume "risk evaluation" may fully equate with the term "risk assessment," given the context of its use (integrating hazard with exposure) in the LCSA, EPA is encouraged to explicitly define and operationalize this term as part of its rulemaking. The term will not have clear meaning until an interpretation is assigned by EPA. We believe the essential elements of a Section 6 and 26 risk evaluation must be articulated in a clear regulatory definition as we discuss below. 6 EPA, Problem Formulation and Initial Assessment Tetrabromobisphenol A and Related Chemicals Cluster Flame Retardants, 2015, available at: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/tsca-work-plan-chemical-problem- formulation-and-2. 8 IPage Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 Section 6(b)(4)(B) of the statute requires EPA to establish, by rule, "a process to conduct risk evaluations." This process is itself required to meet a number of substantive elements described in the LCSA; a risk evaluation must: Be conducted in a manner designed to help the agency determine "whether a chemical substance presents an unreasonable risk of injury to health or the environment;" as set out in Section 6(b)(4)(A). Include consideration of "an unreasonable risk to a potentially exposed or susceptible subpopulation." EPA must identify relevant potentially exposed or susceptible subpopulations relevant to the risk evaluation under conditions of use; Address the specific elements set out in Section 6(b)(4)(F); and Comply with the specific requirements of Section 26, including the best available science, weight of the evidence, and transparency requirements. The very purpose of the risk evaluation is to develop the evidentiary and scientific basis to enable EPA to complete the risk determination required by statute. That risk determination has substantive impact - it significantly affects conduct, activity or a substantive interest that is the subject of agency regulation. The basis for the risk determination thus should be adequately described in the rule itself to offer sufficient notice to the regulated community. This is particularly important for decisions that inform safety and safety determinations. Likewise, decisions that have broad reaching impact should be supported in regulations, not merely through guidance or agency policy. 8 While EPA cannot substitute policy or guidance for a regulatory description of what will constitute a complete and robust risk evaluation, we believe the necessary elements can be developed in this rulemaking in a timely manner. VI. The Proposed Rule Should Ensure Consistency with Section 6(b)(4)(F) As discussed below, Section 6(b)(4)(F) of the LCSA describes five requirements for risk evaluations that shall be considered by the Administrator and must be incorporated into the risk evaluation rulemaking. 7 See, e.g., MST Express v. U.S. Department of Transportation, 108 F.3d 401 (D.C. Cir. 1997). DOT was directed under the Motor Carrier Safety Act (MCSA) to "prescribe regulations establishing a procedure to decide on the safety fitness of owners and operators of commercial motor vehicles." [Emphasis added]. The MCSA stated that implementing regulations would include "a means of deciding whether the owners, operators, and persons meet the safety fitness requirements." DOT promulgated regulations that set out a process for decision making but used guidance to articulate the tests by which the agency would determine whether vehicles met the safety fitness requirements. The court rejected DOT's reliance on guidance because it "failed to carry out its statutory obligation to establish by regulation a means of determining whether a carrier has complied with the safety fitness requirements." 8 As a general matter, "...it seems to be established that "regulations,' 'substantive rules' or 'legislative rules' are those which create law, usually implementary to an existing law." Gibson Wine Co. v. Snyder, 194 F.2d 329, 331 (D.C. Cir. 1952), cited by Brown Express, Inc. v. U.S., 607 F.2d 695, 700 (5th Cir. 1979). A "rule" is defined under Section 2 of the Administrative Procedure Act, in relevant part, as: "the whole or part of an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy or describing the organization, procedure, or practice requirements of an agency." 5 U.S.C. § 551(4). 9 I Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226

On what , the EPA may rely when in need of additional data?

kzbn0226

kzbn0226_p32, kzbn0226_p33, kzbn0226_p34, kzbn0226_p35, kzbn0226_p36, kzbn0226_p37, kzbn0226_p38, kzbn0226_p39

on models and extrapolations.

screening level quantitative risk analysis in the scope phase. Screening-level assessments require less data and information, and are typically deterministic and based on conservative, health protective assumptions and methods. When a screening assessment indicates low risk for a particular condition of use, the Agency should have a high degree of confidence that the potential risks are much lower than the calculation and, therefore, the actual risks are lower and/or perhaps non-existent. Examples of low risk conditions of use could include occupational uses already regulated under OSHA, de minimis uses, or feedstock uses where the use is already regulated, as discussed above in Sections I(D)- I(F) However, when a screening-level risk assessment indicates a potential concern for an adverse effect, this does not mean that the actual risks are significant and warrant action. Rather, it indicates the Agency should take a second step in the risk evaluation process to refine the evaluation to more accurately quantify potential risks. This tiered, iterative approach is consistent with EPA's exposure assessment practices, where screening level tools, which are "protective by design," may be used initially, and then if needed, higher tier tools, which are "more complex and allow for more realistic exposure assessments" can later be employed. 69 i 10 Workplan High-Quality Refined Risk Evaluation High Priority Chemicals & DRAFT Chemicais Manufacturer Risk Evaluation Requested EXPOSUNE HAZARO ASSESSMENE Evaluation incorporating Sections 6 and 26 of the Lautenberg Chemical Safety Act (LCSA): Scope/Screening Level Risk Evaluation Scientifio Standards FINAL Susceptible Weight of Scientific Evidence Evaluations Risk Evaluation Exposures Maxands CONDITIONS or USE Certain Conditions of Use Present Do not present an unreasonable risk an unreasonable risk Refined No further risk evaluation risk evaluation No further action; needed RULEMAKING PROCESS COMPLETE Figure 1. A Two-Step Process for Conducting Risk Evaluations Note this is a simplified version of the process, see text for more detail i. Conditions of Use Requiring No Further Evaluation Once the draft scope is complete, there will likely be conditions of use which will not require any further evaluation as they are unlikely to present an unreasonable 69 28/Page Source: https://www.industrydocuments.ucsf.edu/docs/kzbn0226 risk to human health or the environment. After EPA takes comment on these findings and finalizes the scope document, EPA should formally announce the conditions of use that "do not present an unreasonable risk." While EPA may make additional findings of "does not present unreasonable risk" after the refined risk evaluation is complete, for those conditions of use that do not require further evaluation after scoping, there is no reason for EPA to wait the 3 to 3.5 years to complete the refined risk evaluation before announcing these findings. Once announced, the determination of "does not present unreasonable risk" for the specific condition(s) of use should be considered final agency action. ii. Ensuring Sufficient Information to Conduct a Refined Risk Evaluation While EPA intends to only conduct risk evaluations on those chemicals for which sufficient information exists, there will likely be a few cases where, once a screening level evaluation is complete, EPA will realize that certain data needs preclude conducting a refined risk evaluation. In such cases, where EPA may need to use test rules, orders or consent agreements to gather existing or new information, EPA should pause the risk evaluation process. This pause will allow the needed data to be generated in a scientifically robust manner. When this is necessary, EPA should announce this pause and its expected length in the Federal Register. EPA should also use the Federal Register to notify the public when the pause ends and the risk evaluation commences. ACC expects that EPA will not need to pause assessments frequently, but EPA should be aware that there may be cases that necessitate the use of a pause. As ACC discusses in our comments on the Prioritization Framework, during the prioritization process, it is not appropriate for EPA to collect data to conduct full risk evaluations.70 B. Refined Risk Evaluation The additional steps of the risk evaluation process include hazard assessment, exposure assessment, risk characterization, public comment, and peer review. Further details regarding the specific elements that should be in different sections of the risk evaluation are included in the appendices of ACC's August 24, 2016 comments. 71 As they were clearly presented to the Agency and are in the public docket, while they are still relevant, we will not reiterate them here. While previously emphasized in these comments, ACC reiterates that it will be important throughout the refined risk evaluation process that EPA always rely on the best available science and follow a WoE approach that incorporates systematic review processes. 70 See ACC comments on the Prioritization Framework Rule, submitted on March 20, 2017. 71 See ACC comments, at Appendices B-E, available at: butps//www.regulations.gos/document?D=EPA-HQ-OPPT 2016-0400-0028. 29/Page Source: https://www.industrydocuments.ucsf.edu/docs/kzbn0226 Comments on the sections of the risk evaluation process that have not been previously addressed above are presented in this section. i. Hazard Assessment When conducting refined hazard assessments for human health or environmental endpoints, EPA must rely on the data (reasonably available information that is scientifically valid, as defined in Section IV of these comments) first and foremost. When additional data are needed, EPA may rely on models and extrapolations. All assumptions and uncertainties associated with these models and extrapolations must be transparently discussed. When EPA is faced with conflicting data or data that could be interpreted in multiple scientifically plausible ways, EPA should strive to present the full range of scientifically supportable analyses for consideration. As the types of data that will be available for the agency to consider will vary for each chemical and as science advances (e.g., high throughput screening tools), EPA should not specifically mandate the types of data that will be used. There will likely be cases where these data do not exist or are not of sufficient quality. In addition, EPA states that it will evaluate, as appropriate, "acute, subchronic, and chronic effects during various stages of reproduction or life stage."72 We urge EPA to ensure that these evaluations are necessary for the relevant conditions of use. Otherwise the Agency will spend too much time focusing on subpopulations or durations that are not relevant or critical to the refined risk evaluation. EPA must also verify that scientifically valid information exists to inform each of these scenarios and that consistent with WoE and systematic review practices, data are evaluated based on their strengths and limitations. The criteria that will be used to evaluate the strengths and limitations of studies from different streams (epidemiologic, toxicologic, mechanistic), should be presented in the protocol that is released with the scope document. EPA states that dose-response assessments will be included where possible. 73 EPA should describe transparent criteria that will be used throughout the risk evaluation process to determine if the data are of sufficient quality for dose-response assessment. Conducting dose-response assessment on data of inadequate quality will likely lead to misleading and unreliable findings in the risk characterization step. For environmental hazard assessment, EPA notes that the agency may rely on 74 incident data. ACC cautions EPA on this approach as incident data is very situational specific, requires a deep understanding of the particular situation and may not be of sufficient quality for use in other situations. Therefore, EPA should 72 See 82 Fed. Reg. at 7579. 73 Id. at 7571. 74 Id. at 7579. 30/Page Source: https://www.industrydocuments.ucsf.edu/docs/kzbn0226 judiciously use this information and must be extremely transparent regarding all assumptions and uncertainties when incident data are used. Similarly, EPA states that the Agency may also consider ecological field data. 75 ACC appreciates that EPA will consider using these data over modeling data as this is consistent with EPA's data preference hierarchy. 76 Consistent with this hierarchy, EPA must ensure that the data are valid, reliable and relevant for the decision being made. ii. Exposure Assessment For refined exposure assessment, above all else, EPA must ensure that it is using high quality representative data that are reflective of current uses for the conditions of use that are of concern. Similar to the necessity to clarify how the strengths and limitations of hazard information will be evaluated, EPA should also clearly present the approach that will be used to evaluation exposure information. As data and models permit, EPA must strive to use probabilistic exposure analyses.77 iii. Risk Characterization To ensure that risk characterization is robust and consistent with not only EPA's 2000 Risk Characterization Handbook and EPA Information Quality Guidelines, 78 we recommend that EPA include the following description in the regulatory text, which is consistent with those documents: In the risk characterization, particularly when there are findings that a chemical presents an unreasonable risk, for each condition of use evaluated, EPA will present (i) each population addressed by any estimate of applicable human health risk or each risk assessment endpoint, including populations if applicable, addressed by any estimate of applicable ecological risk; (ii) the expected risk or central estimate of risk of the human health risk for the specific populations affected or the ecological assessment endpoints, including populations if applicable; (iii) each appropriate upper-bound or lower-bound estimate of risk; (iv) each significant uncertainty identified in the process of the assessment of risk and the studies that would assist in resolving the uncertainty; and (v) peer- reviewed studies known to the Agency that support, are directly relevant to, or fail to support any estimate of risk and the methodology used to reconcile inconsistencies in the scientific data. 75 Id. at 7571. 76 See 77 This recommendation is consistent with the comments from the CSAC on the 1-bromopropane review, see Chemical Safety Advisory Committee Minutes No. 2016-02, at 13. 78 See EPA Risk Characterization Handbook, available at bitps:/www.epa.gov/sites/production/files/2015. 10/documents/osp risk characterization bandbook 2000.pdf. 31/Page Source: https://www.industrydocuments.ucsf.edu/docs/kzbn0226 In addition, the risk characterization summary should be consistent with the Section 26 science standards. As such, EPA should also include the following language at $702.41 in the regulatory text: This summary will include, as appropriate, a discussion of (1) the extent to which the scientific information, technical procedures, measures, methods, protocols, methodologies, or models employed to generate the information are reasonable for and consistent with the intended use of the information; (2) the extent to which the information is relevant for the Administrator's use in making a decision about a chemical substance or mixture; (3) the degree of clarity and completeness with which the data, assumptions, methods, quality assurance, and analyses employed to generate the information are documented; (4) the extent to which the variability and uncertainty in the information, or in the procedures, measures, methods, protocols, methodologies, or models, are evaluated and characterized; and (5) the extent of independent verification or peer review of the information or of the procedures, measures, methods, protocols, methodologies, or models. EPA notes, in particular, that the Agency may exercise its discretion to include discussion of any alternative interpretation of results. 79 This statement should be clarified. To resolve differences of scientific opinion, when reasonable judgments may lead to different interpretations or alternative methods (e.g., linear and non- linear cancer modeling), the Agency should always err on the side of presenting all scientifically valid approaches. Presentation of alternatives should be the norm, not the exception. For environmental evaluations, EPA notes that the Agency may consider "effects at the individual, species and community level Environmental assessments are ,,80 typically focused on protecting populations, not necessarily individual environmental organisms. EPA must clearly justify any environmental 81 assessments that are conducted at the individual level. Finally, risk characterization should strive to present what is commonly termed a "reality check.' EPA should ensure that its final estimate of risk is reasonable and is scientifically sound considering what is widely known about the chemical and its condition(s) of use. A good example of this can be found in a few earlier assessments that EPA conducted. 82 79 See 82 Fed. Reg. at 7571. 80 Id. 81 See EPA's Ecological Risk Assessment Guidance for Superfund: Process for Designing and Conducting Ecological Risk Assessments, 1997, available at hups:/isemspub.epa.gov/work/HQ/15794Lpdi 82 See for example EPA's 1985 Mutagenicity and Carcinogenicity Assessment of 1,3-Butadiene, at 6-70 and 6-71 available at 32/Page Source: https://www.industrydocuments.ucsf.edu/docs/kzbn0226 C. Publicly Available Information Consistent with Section 26(j) of the LCSA, EPA commits to making information available to the public. ACC concurs with this approach and has a few suggested additions for what should be made available. Consistent with our comments on peer review, EPA should ensure that there is an opportunity for the public to provide comments to peer review panels on key areas of the assessments that warrant detailed review, and the peer reviewers should subsequently provide responses to substantive scientific public comments that they receive. These public comments and the peer reviewer responses should be included in the final peer review report that is placed in the public docket. In addition to providing a response to public comments received on the draft risk evaluation, EPA should provide a similar response to public comments received on the draft scope document. Both sets of agency responses should be in the public docket. To ensure that CBI is appropriately used in the risk evaluation process, EPA should use an appropriate third party to review this information. The report from this review should also be placed in the public docket, safeguarding all CBI. This approach will help to facilitate the agencies use of CBI in the risk evaluation process, as appropriate. D. Reassessment 83 EPA states that the Agency may reassess a final unreasonable risk determination at any time. EPA should clarify that EPA may reassess a finding of "no unreasonable risk" or a finding of "unreasonable risk" based on a review of available information. There is no justification for reassessment to apply only to findings of "no unreasonable risk.' The requirements for reassessment must be applied equally to both positive and negative risk findings. EPA should put in place a transparent petition process that will allow the public to comment on chemicals and conditions of use that may require reassessment. In addition, ACC recommends that when a determination is made to reassess a chemical substance, the Agency begin with prioritization before proceeding to risk evaluation. E. Third Party Assessments While EPA has not yet released guidance to assist persons interested in developing and submitting draft risk evaluations which shall be considered by the Administrator, EPA should expect to receive some risk evaluations from third parties for consideration in the process. The ANONYMOUS&Passwordeanonymous&SortMethodmh%70.- y=135. 83 See 82 Fed. Reg. at 7580. 33/Page Source: https://www.industrydocuments.ucsf.edu/docs/kzbn0226 final rulemaking should describe the process the Agency will use for internally reviewing these risk evaluations and for moving them to peer review expeditiously. When submitted evaluations follow the same policies and procedures that will be described in the final risk evaluation rule, EPA should commit to reviewing draft risk evaluations within 90 days. This timeframe is consistent with the period of time ACC proposes that EPA allow for public comment on risk evaluations developed by the Agency. ACC also recommends that public comment be simultaneous with internal EPA review. Once the review process is complete, these assessments should move to peer review. VII. Additional Definitions The proposed rule discusses other important definitions. Some are new, while others are redefinitions of existing terms. Below ACC provides recommendations to inform EPA's use and interpretation of a few of these definitions. A. Aggregate Exposure While EPA provides an appropriate definition of aggregate exposure, consistent with the definition in the EPA Exposure Factors Handbook, ACC is concerned that when considering aggregate exposures, EPA may go beyond the intended scope of what should be in a risk evaluation under the LCSA. Risk evaluations conducted under the LCSA should be consistent with the scope of the LCSA. For instance, the LCSA does not cover the evaluation of pesticides, foods, food additives, drugs, cosmetics, tobacco products, etc. As such, it would be inappropriate for consideration of aggregate exposure to lead to a risk evaluation of non-LCSA products. If EPA felt it necessary to consider such products, any assessment conducted should be done only on a case specific basis and in consultation with the appropriate Agency or program with the statutory authority for the review and assessment of that product. EPA should commit to including relevant authorities and experts when there are such cases. We expect the need to conduct these consultations to be the exception rather than the norm. B. Categories of Chemical Substances The term "category of chemical substances" is clearly defined in Section 26(c) of the LCSA. In the proposed rule, EPA specifically notes that, where appropriate, a risk evaluation may be conducted on a category of chemical substances. ACC supports this approach. EPA explicitly seeks comment on areas where additional transparency, public accountability, and opportunities for public comment can be improved.84 To be consistent with cross-cutting requirements in Section 26(h), and to be consistent with EPA's general commitment to transparency and public accountability, when EPA finds that it is appropriate to consider a category of chemical substances, this finding should be clearly explained. The justification should include all the factors and considerations which led to the determination that a category approach was appropriate. When such an approach is taken, before EPA begins their risk evaluation, EPA should solicit public comment on its determination that it is appropriate. 84 See 82 Fed. Reg. at 7565. 34/Page Source: https://www.industrydocuments.ucsf.edu/docs/kzbn0226 C. Potentially Exposed and Susceptible Populations This term is clearly described in the statute. There is no need for EPA to reinterpret it or broaden the definition. The edits below bring the proposed definition in the regulatory text in line with the statutory definition: Potentially exposed or susceptible subpopulation means a group of individuals within the general population identified by the Agency who, due to either greater susceptibility or greater exposure, may be at greater risk than the general population of adverse health effects from exposure to a chemical substance or mixture, including but not limited to, as infants, children, pregnant women, workers, or the elderly. EPA may identify a susceptible subpopulation in an individual risk evaluation upon consideration of various intrinsic (e.g., life stage, reproductive status, age, gender, genetic traits) or acquired (e.g. pre existing disease, geography, workplace) characteristics that may affect exposure or modify the risk of illness or disease. EPA has suggested modifying the statutory definition for two stated reasons: to clarify that EPA may identify additional populations where warranted, and to include specific authorization for EPA to consider broader factors (e.g., consideration of various intrinsic or acquired factors) when identifying this population. The term "such as" is sufficiently clear to allow EPA to 85 identify additional subpopulations when needed. Had Congress intended to explicitly include other subpopulations, Congress would have chosen different language. Similarly, if Congress felt the need to explicitly define what factors EPA must consider (e.g., intrinsic and extrinsic factors), these factors would have been included in the definition. This is not an area in need of clarification in the regulatory definition. Similarly, EPA broadens the definition to include explicit consideration of those with illness or disease. While such considerations may very well be appropriate in case-by-case situations for particular conditions of use, had Congress intended this consideration for each condition of use evaluated under the LCSA, the language would have been included in the statute. EPA's proposed revision is clearly intended to broaden the scope of EPA's evaluation. Congress did not support such a broad scope, nor does ACC. We recommend that EPA finalize the definition provided in the statute. D. Sentinel Exposure EPA provides a definition for sentinel exposure and notes that while it is not a novel way of characterizing exposure, it is a new term for EPA. 86 EPA does not identify the source for its definition. ACC is concerned that EPA's proposed definition does not reflect a fundamental understanding of how the concept of sentinel exposure has been used by other national authorities, such as Health Canada or the European Union (EU). In fact the term and use of sentinel exposures is not new in either jurisdiction; as such, it is not new to U.S. chemical manufacturers. The concept of 85 Id. at 7576. 86 Id. at 7658. 35/Page Source: https://www.industrydocuments.ucsf.edu/docs/kzbn0226

In which year atomic energy act came into force?

kzbn0226

kzbn0226_p8, kzbn0226_p9, kzbn0226_p10, kzbn0226_p11, kzbn0226_p12

1954

At the same time, risk evaluations must meet Section 26 quality requirements, using best available science and weight of the evidence review. To achieve the throughput and quality requirements for risk evaluation, Congress designed a process to allow chemicals to be systematically prioritized and evaluated. This design is apparent throughout LCSA. It begins with a reset of the TSCA Inventory -- the full catalog of chemicals in commerce. LCSA requires that the TSCA Inventory be sorted, so that chemicals that are currently active in commerce are separated from those not currently used. This sorting enables EPA to identify only those chemicals that are active in commerce for prioritization and risk evaluation. This statutory design makes eminent sense: it allows EPA to focus resources for its multi-year, time- and resource-intensive risk evaluations on chemicals that are actually being used. From this initial focusing step, LCSA repeatedly requires EPA to further refine its focus throughout prioritization and risk evaluation. EPA must next implement a prioritization process, which further refines the active chemicals in commerce to those that are high priority for risk evaluation. These chemicals must then undergo a scoping exercise to further focus on the conditions of use that will be the subject of the risk evaluation. In implementing LCSA, EPA has indicated that it intends to identify and consider all conditions of use of a chemical in all risk evaluations, all the time. This interpretation cannot be reconciled with EPA's statutory directive to achieve throughput and quality in risk evaluations. It is inconsistent with the design of the statute; inconsistent with congressional intent to give EPA the flexibility to make case-by-case scoping decisions; and undermines statutory purposes and the effective function of the statute itself. A. There is No Statutory Mandate to Include All Conditions of Use in the Scope of Every Risk Evaluation Under TSCA § 6(b). EPA notes in the preamble that, prior to enactment of LCSA, the Agency was "free to and did" conduct risk assessments on selected uses of chemical substances, but that it now interprets the amended statute as "requiring that risk evaluations encompass all manufacture, processing, distribution in commerce, use, and disposal activities [t]hat is to say, a risk evaluation must encompass all known, intended, and reasonably foreseen activities associated with the subject chemical substance" [emphasis added]. ACC strongly disagrees with this interpretation -- EPA 3 is reading a mandate into the statute where none exists. Rather, Congress equipped EPA with the tools to scope risk evaluations in order to achieve statutory purposes, and EPA should use those tools accordingly. The statute does not require EPA to include "all" conditions of use in any particular risk evaluation, or in each and every risk evaluation. Nowhere in the statute does Congress modify "conditions of use" with "all." EPA has the discretion to interpret the term. It cannot apply this discretion in such a manner, however, as to undercut the operation of the statute or to make it impossible for EPA to meet its statutory objectives of throughput and quality. 3 82 Fed. Reg. at 7565. 4/Page Source: https://www.industrydocuments.ucsf.edu/docs/kzbn0226 B. Scoping Necessarily Requires EPA to Select Relevant Conditions of Use for Inclusion, and Scope Accordingly. LCSA requires EPA to conduct risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment under certain circumstances called "conditions of use. ,,4 Conditions of use are defined as "the circumstances, as determined by [EPA], under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of." The legislative text did not direct EPA to include "all" conditions of use. The statute creates a scoping process that precedes the risk evaluation itself. For a scoping process to have any reasonable meaning, it must actually "scope" -- on a case by case basis, it must determine which conditions of use are appropriate for inclusion because they are relevant and meaningful to the risk evaluation process. EPA's plan to universally include "all conditions of use" all the time in every risk evaluation is contrary to common sense, conflicts with and undermines the statutory design of TSCA as amended by LCSA, and would lead to an absurd result. 5 EPA's preamble acknowledges the value of scoping (also called problem formulation) in citing the National Academy of Sciences (NAS) National Research Council (NRC) Science and Decisions Report. The NAS report recommended that EPA focus on the "important roles of scoping or problem formulation so that a risk assessment will serve a specific and documented purpose" [emphasis added]. The preamble cites an additional NAS recommendation to EPA 6 that the Agency "develop risk assessments that are well-tailored to the problems and decisions at hand so that they can inform the decision-making process in the most meaningful way." We agree, and urge the agency to apply these recommendations to the scoping process. C. The Legislative Text Acknowledges that What EPA Will Consider and Include in a Given Scope Necessarily Varies. The scoping provision requires identification of those conditions EPA "expects to consider," a clause that would be unnecessary if EPA were directed to simply include "all" conditions of use in a risk evaluation. The future tense also acknowledges that EPA might subsequently change 8 4 TSCA § 6(b)(4)(A). 5 See Massachusetts v. EPA, 549 U.S. 497, 531, 535 (2007) addressing EPA's application of its Chevron deference to particular statutory constructions: EPA not required to regulate "all" greenhouse gases as "air pollutants" everywhere that term appears in the statute; EPA must ground its reasons for action or inaction in the statute; agency regulation cannot conflict with statutory design, and law cannot be read to compel EPA to regulate in a manner contrary to "common sense." 6 82 Fed. Reg. at 7265. 7 TSCA § 6(b)(3)(D). 8 Before LCSA was enacted, EPA had published multiple problem formulations under the TSCA Work Plan. EPA explained that its problem formulations served as a means for explaining the scope of a risk assessment: "A problem formulation and initial assessment document will serve to inform the public and other interested stakeholders about EPA's initial scoping of findings and plan for any further risk assessment. Problem formulation and initial assessment is the analytical phase of the assessment in which the purpose for the assessment is articulated, the problem defined and a plan for analyzing and characterizing risk is determined." Many of those completed problem formulations were for limited conditions of use. Like other aspects of the TSCA Work Plan, Congress 5/Page Source: https://www.industrydocuments.ucsf.edu/docs/kzbn0226 its position with respect to what conditions of use to include or exclude. Notably, this construction affords EPA the discretion to include all conditions of use where necessary. This is consistent with congressional intent. Speaking about the compromise bill that was signed into law, Senator Vitter said that EPA "is given the discretion to determine the conditions of use that the Agency will address in its evaluation of the priority chemical." This discretion and flexibility "assures that the Agency's focus is on conditions of use that raise the greatest potential for risk" particularly given that "many TSCA chemicals have multiple uses - industrial, commercial and consumer uses" and EPA is "well aware that some categories of uses pose greater potential for exposure than others and that the risks from many categories of uses are deemed negligible or already well controlled."9 D. EPA Should Expressly Exclude Substances that Are Not Regulated Under TSCA from the Scope of Risk Evaluations. TSCA excludes a number of chemical categories from its statutory scope. LCSA did not change these; accordingly, these categories should not be considered for inclusion in any risk evaluation undertaken pursuant to Section 6: (i) [a]ny mixture, (ii) any pesticide (as defined in the Federal Insecticide, Fungicide, and Rodenticide Act) when manufactured, processed, or distributed in commerce for use as a pesticide; (iii) tobacco or any tobacco product, (iv) any source material, special nuclear material, or byproduct material (as such terms are defined in the Atomic Energy Act of 1954 and regulations issued under such Act), (v) any article the sale of which is subject to the tax imposed by section 4181 of the Internal Revenue Code of 1986 [i.e., firearms and ammunition] (vi) any food, food additive, drug, cosmetic, or device (as such terms are defined in section 201 of the Federal Food, Drug, and Cosmetic Act) when manufactured, processed, or distributed in commerce for use as a food, food additive, drug, cosmetic, or device. The risk evaluation rule should expressly clarify that because these categories are excluded from the definition of "chemical substance" under TSCA, and they are outside EPA's legislative authority to regulate, they therefore excluded from the scope of risk evaluations under Section 6. contemplated that problem formulations from the TSCA Work Plan would serve as the model for EPA actions under the amended TSCA. In this case, the problem formulations were to be the model for the scoping exercise under Section 6(b)(4)(D). This is a strong indication that Congress authorized EPA to determine which conditions of use it would evaluate in a risk evaluation by defining the scope appropriately. 9 Senate Congressional Record, June 7, 2016, at S3519; available at also clarifies that unreasonable risk/no unreasonable risk determinations made pursuant to the risk evaluation are made use-by-use: "[T]o be clear, every condition of use identified by the Administrator in the scope of the risk evaluation must, and will be either found to present or not present an unreasonable risk." Id. at S3520. 6/Page Source: https://www.industrydocuments.ucsf.edu/docs/kzbn0226 Likewise, the rule should clarify that chemical uses within these exclusions are "conditions of use" that are outside the scope of any Section 6 risk evaluation. In addition to TSCA, which was modernized by the passage of LCSA in 2016, there is a network of statutes in place regulating the safety of chemicals in various venues and applications. Several other federal statutes are in place to regulate chemicals in products and during activities such as workplace manufacturing. Notably, the Consumer Protection Act, Consumer Product Safety Improvement Act, and the Federal Hazardous Substances Act regulate chemicals in a suite of consumer products, including children's products and toys, and the Occupational Safety and Health Act (OSH Act) regulates chemicals in the workplace. Chemicals in uses regulated by other federal laws and agencies are often referred to as "non- TSCA" uses. EPA should not include these uses in its risk evaluations under TSCA. In rare cases where inclusion might be justified, the Agency should establish criteria to justify including non-TSCA uses in its risk evaluations and should articulate the steps it will follow to ensure adequate interagency consultation and review at the scoping stage. We discuss this topic in more detail below. E. EPA Should Generally Exclude OSHA-Regulated Uses from the Scopes of TSCA Risk Evaluations. Although LCSA specifically includes "workers" as a possible category of "potentially exposed or susceptible subpopulation," it does not designate "workers" as a default category. Any consideration of worker exposure must begin with the recognition that worker exposures are regulated under the OSH Act. Given that Occupational Safety and Health Administration (OSHA) standards are in place for the very purpose of regulating risk to worker populations, it should be the unusual case where unreasonable risk may present to a worker population under conditions of use (e.g., use of personal protective equipment). Importantly, although Congress recognizes under LCSA that it may be appropriate, under particular circumstances, for EPA to designate workers as a potentially exposed or susceptible subpopulation under TSCA, and to regulate workplace exposures, Congress did not amend the OSH Act at the same time that it amended TSCA. Congress also left Section 9(d) of TSCA intact. This section requires EPA to consult and coordinate with OSHA "for the purpose of achieving the maximum enforcement of [TSCA] while imposing the least burdens of duplicative requirements on those subject to [TSCA] and for other purposes.' EPA should ensure that this consultation occurs before risk evaluations are scoped; in cases where worker exposures do not present a significant risk of health impairment under current conditions of use, EPA should decline to include worker populations within the scope of the risk assessment as unduly burdensome and duplicative. This process will help focus risk evaluations and reduce the resource cost to the Agency. Following this consultation, if OSHA agrees that EPA-led risk evaluation considering worker exposures is necessary (and not otherwise duplicative), EPA should describe the process it used to consult with OSHA and the basis for its findings in the scope of the risk evaluation. 7/Page Source: https://www.industrydocuments.ucsf.edu/docs/kzbn0226 F. EPA Should Generally Exclude Low Exposure Conditions of Use from the Scopes of TSCA Risk Evaluations. In the prioritization process, certain scenarios may emerge that are low- - to no-exposure. An example is a closed system, intermediate chemical manufacture or processing at an industrial site, where worker exposure is well documented and controlled, and does not present a significant risk. A second example would be de minimis levels of an impurity in a consumer product, where the levels and variability are well documented and well understood, and exposures are so low as not to present a significant risk. In such cases, it should be apparent in the prioritization process or before scoping that these use scenarios can readily be excluded from the scope of the risk evaluation. G. EPA Should Apply the "Reasonably Foreseen" Provision as a Focusing Tool to Help Tailor the Scope of Risk Evaluations - Not to Expand Them. The statutory definition of "conditions of use" is "the circumstances, as determined by the Administrator, under which a chemical substances is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used or disposed of.">10 The phrase "intended, known, or reasonably foreseen" limits the conditions of use that may be identified and included in a scope. Clearly, if a particular use is not intended, known, or reasonably foreseen, it is not a statutory "condition of use" and may not be included within the scope of a risk evaluation. The term "intended" is generally well understood to mean intended by the manufacturer or processor. Intention can be demonstrated through express (e.g., a statement to that effect in a premanufacture notice) or implied evidence (e.g., marketing materials that imply a potential application for the chemical). The term "known" is often considered a backstop for the term "intended," in that manufacturers or processors may not "intend" or support a particular downstream use for a chemical but may have actual or imputed knowledge that a chemical is being used in that application. The definition of "conditions of use" also includes the term "reasonably foreseen." The concept of reasonable foreseeability is well understood in American and western11 tort law. Foreseeability is "the determinant for the limits of duty under a conventional risk analysis" [emphasis added]. Foreseeability is modified by "reasonably," which makes clear that not 12 every conceivable or speculative use is included. Product misuses and illegal uses, and manufacturing that disregards legal and industrial hygiene requirements, are not "reasonable" and thus not "reasonably foreseen." 10 TSCA §3(4). 11 See, e.g., ANNEXURE T, The Concept of Limited Liability, Existing Law and Rationale (Australia), referring to the limiting tests of reasonable foreseeability and proximity, available at htp:/lwww.dpc.nsw.gov.au data/assets/odf.file/0012/11406/T.pdi 12 Tyrus V. Dahl Jr., Strict Products Liability: The Irrelevance of Foreseeability and Related Negligence Concepts, 14 Tulsa L. J. 338, 343 (1978). 8/Page Source: https://www.industrydocuments.ucsf.edu/docs/kzbn0226

under which section the tax is imposed?

kzbn0226

kzbn0226_p8, kzbn0226_p9, kzbn0226_p10, kzbn0226_p11, kzbn0226_p12

4181

At the same time, risk evaluations must meet Section 26 quality requirements, using best available science and weight of the evidence review. To achieve the throughput and quality requirements for risk evaluation, Congress designed a process to allow chemicals to be systematically prioritized and evaluated. This design is apparent throughout LCSA. It begins with a reset of the TSCA Inventory -- the full catalog of chemicals in commerce. LCSA requires that the TSCA Inventory be sorted, so that chemicals that are currently active in commerce are separated from those not currently used. This sorting enables EPA to identify only those chemicals that are active in commerce for prioritization and risk evaluation. This statutory design makes eminent sense: it allows EPA to focus resources for its multi-year, time- and resource-intensive risk evaluations on chemicals that are actually being used. From this initial focusing step, LCSA repeatedly requires EPA to further refine its focus throughout prioritization and risk evaluation. EPA must next implement a prioritization process, which further refines the active chemicals in commerce to those that are high priority for risk evaluation. These chemicals must then undergo a scoping exercise to further focus on the conditions of use that will be the subject of the risk evaluation. In implementing LCSA, EPA has indicated that it intends to identify and consider all conditions of use of a chemical in all risk evaluations, all the time. This interpretation cannot be reconciled with EPA's statutory directive to achieve throughput and quality in risk evaluations. It is inconsistent with the design of the statute; inconsistent with congressional intent to give EPA the flexibility to make case-by-case scoping decisions; and undermines statutory purposes and the effective function of the statute itself. A. There is No Statutory Mandate to Include All Conditions of Use in the Scope of Every Risk Evaluation Under TSCA § 6(b). EPA notes in the preamble that, prior to enactment of LCSA, the Agency was "free to and did" conduct risk assessments on selected uses of chemical substances, but that it now interprets the amended statute as "requiring that risk evaluations encompass all manufacture, processing, distribution in commerce, use, and disposal activities [t]hat is to say, a risk evaluation must encompass all known, intended, and reasonably foreseen activities associated with the subject chemical substance" [emphasis added]. ACC strongly disagrees with this interpretation -- EPA 3 is reading a mandate into the statute where none exists. Rather, Congress equipped EPA with the tools to scope risk evaluations in order to achieve statutory purposes, and EPA should use those tools accordingly. The statute does not require EPA to include "all" conditions of use in any particular risk evaluation, or in each and every risk evaluation. Nowhere in the statute does Congress modify "conditions of use" with "all." EPA has the discretion to interpret the term. It cannot apply this discretion in such a manner, however, as to undercut the operation of the statute or to make it impossible for EPA to meet its statutory objectives of throughput and quality. 3 82 Fed. Reg. at 7565. 4/Page Source: https://www.industrydocuments.ucsf.edu/docs/kzbn0226 B. Scoping Necessarily Requires EPA to Select Relevant Conditions of Use for Inclusion, and Scope Accordingly. LCSA requires EPA to conduct risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment under certain circumstances called "conditions of use. ,,4 Conditions of use are defined as "the circumstances, as determined by [EPA], under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of." The legislative text did not direct EPA to include "all" conditions of use. The statute creates a scoping process that precedes the risk evaluation itself. For a scoping process to have any reasonable meaning, it must actually "scope" -- on a case by case basis, it must determine which conditions of use are appropriate for inclusion because they are relevant and meaningful to the risk evaluation process. EPA's plan to universally include "all conditions of use" all the time in every risk evaluation is contrary to common sense, conflicts with and undermines the statutory design of TSCA as amended by LCSA, and would lead to an absurd result. 5 EPA's preamble acknowledges the value of scoping (also called problem formulation) in citing the National Academy of Sciences (NAS) National Research Council (NRC) Science and Decisions Report. The NAS report recommended that EPA focus on the "important roles of scoping or problem formulation so that a risk assessment will serve a specific and documented purpose" [emphasis added]. The preamble cites an additional NAS recommendation to EPA 6 that the Agency "develop risk assessments that are well-tailored to the problems and decisions at hand so that they can inform the decision-making process in the most meaningful way." We agree, and urge the agency to apply these recommendations to the scoping process. C. The Legislative Text Acknowledges that What EPA Will Consider and Include in a Given Scope Necessarily Varies. The scoping provision requires identification of those conditions EPA "expects to consider," a clause that would be unnecessary if EPA were directed to simply include "all" conditions of use in a risk evaluation. The future tense also acknowledges that EPA might subsequently change 8 4 TSCA § 6(b)(4)(A). 5 See Massachusetts v. EPA, 549 U.S. 497, 531, 535 (2007) addressing EPA's application of its Chevron deference to particular statutory constructions: EPA not required to regulate "all" greenhouse gases as "air pollutants" everywhere that term appears in the statute; EPA must ground its reasons for action or inaction in the statute; agency regulation cannot conflict with statutory design, and law cannot be read to compel EPA to regulate in a manner contrary to "common sense." 6 82 Fed. Reg. at 7265. 7 TSCA § 6(b)(3)(D). 8 Before LCSA was enacted, EPA had published multiple problem formulations under the TSCA Work Plan. EPA explained that its problem formulations served as a means for explaining the scope of a risk assessment: "A problem formulation and initial assessment document will serve to inform the public and other interested stakeholders about EPA's initial scoping of findings and plan for any further risk assessment. Problem formulation and initial assessment is the analytical phase of the assessment in which the purpose for the assessment is articulated, the problem defined and a plan for analyzing and characterizing risk is determined." Many of those completed problem formulations were for limited conditions of use. Like other aspects of the TSCA Work Plan, Congress 5/Page Source: https://www.industrydocuments.ucsf.edu/docs/kzbn0226 its position with respect to what conditions of use to include or exclude. Notably, this construction affords EPA the discretion to include all conditions of use where necessary. This is consistent with congressional intent. Speaking about the compromise bill that was signed into law, Senator Vitter said that EPA "is given the discretion to determine the conditions of use that the Agency will address in its evaluation of the priority chemical." This discretion and flexibility "assures that the Agency's focus is on conditions of use that raise the greatest potential for risk" particularly given that "many TSCA chemicals have multiple uses - industrial, commercial and consumer uses" and EPA is "well aware that some categories of uses pose greater potential for exposure than others and that the risks from many categories of uses are deemed negligible or already well controlled."9 D. EPA Should Expressly Exclude Substances that Are Not Regulated Under TSCA from the Scope of Risk Evaluations. TSCA excludes a number of chemical categories from its statutory scope. LCSA did not change these; accordingly, these categories should not be considered for inclusion in any risk evaluation undertaken pursuant to Section 6: (i) [a]ny mixture, (ii) any pesticide (as defined in the Federal Insecticide, Fungicide, and Rodenticide Act) when manufactured, processed, or distributed in commerce for use as a pesticide; (iii) tobacco or any tobacco product, (iv) any source material, special nuclear material, or byproduct material (as such terms are defined in the Atomic Energy Act of 1954 and regulations issued under such Act), (v) any article the sale of which is subject to the tax imposed by section 4181 of the Internal Revenue Code of 1986 [i.e., firearms and ammunition] (vi) any food, food additive, drug, cosmetic, or device (as such terms are defined in section 201 of the Federal Food, Drug, and Cosmetic Act) when manufactured, processed, or distributed in commerce for use as a food, food additive, drug, cosmetic, or device. The risk evaluation rule should expressly clarify that because these categories are excluded from the definition of "chemical substance" under TSCA, and they are outside EPA's legislative authority to regulate, they therefore excluded from the scope of risk evaluations under Section 6. contemplated that problem formulations from the TSCA Work Plan would serve as the model for EPA actions under the amended TSCA. In this case, the problem formulations were to be the model for the scoping exercise under Section 6(b)(4)(D). This is a strong indication that Congress authorized EPA to determine which conditions of use it would evaluate in a risk evaluation by defining the scope appropriately. 9 Senate Congressional Record, June 7, 2016, at S3519; available at also clarifies that unreasonable risk/no unreasonable risk determinations made pursuant to the risk evaluation are made use-by-use: "[T]o be clear, every condition of use identified by the Administrator in the scope of the risk evaluation must, and will be either found to present or not present an unreasonable risk." Id. at S3520. 6/Page Source: https://www.industrydocuments.ucsf.edu/docs/kzbn0226 Likewise, the rule should clarify that chemical uses within these exclusions are "conditions of use" that are outside the scope of any Section 6 risk evaluation. In addition to TSCA, which was modernized by the passage of LCSA in 2016, there is a network of statutes in place regulating the safety of chemicals in various venues and applications. Several other federal statutes are in place to regulate chemicals in products and during activities such as workplace manufacturing. Notably, the Consumer Protection Act, Consumer Product Safety Improvement Act, and the Federal Hazardous Substances Act regulate chemicals in a suite of consumer products, including children's products and toys, and the Occupational Safety and Health Act (OSH Act) regulates chemicals in the workplace. Chemicals in uses regulated by other federal laws and agencies are often referred to as "non- TSCA" uses. EPA should not include these uses in its risk evaluations under TSCA. In rare cases where inclusion might be justified, the Agency should establish criteria to justify including non-TSCA uses in its risk evaluations and should articulate the steps it will follow to ensure adequate interagency consultation and review at the scoping stage. We discuss this topic in more detail below. E. EPA Should Generally Exclude OSHA-Regulated Uses from the Scopes of TSCA Risk Evaluations. Although LCSA specifically includes "workers" as a possible category of "potentially exposed or susceptible subpopulation," it does not designate "workers" as a default category. Any consideration of worker exposure must begin with the recognition that worker exposures are regulated under the OSH Act. Given that Occupational Safety and Health Administration (OSHA) standards are in place for the very purpose of regulating risk to worker populations, it should be the unusual case where unreasonable risk may present to a worker population under conditions of use (e.g., use of personal protective equipment). Importantly, although Congress recognizes under LCSA that it may be appropriate, under particular circumstances, for EPA to designate workers as a potentially exposed or susceptible subpopulation under TSCA, and to regulate workplace exposures, Congress did not amend the OSH Act at the same time that it amended TSCA. Congress also left Section 9(d) of TSCA intact. This section requires EPA to consult and coordinate with OSHA "for the purpose of achieving the maximum enforcement of [TSCA] while imposing the least burdens of duplicative requirements on those subject to [TSCA] and for other purposes.' EPA should ensure that this consultation occurs before risk evaluations are scoped; in cases where worker exposures do not present a significant risk of health impairment under current conditions of use, EPA should decline to include worker populations within the scope of the risk assessment as unduly burdensome and duplicative. This process will help focus risk evaluations and reduce the resource cost to the Agency. Following this consultation, if OSHA agrees that EPA-led risk evaluation considering worker exposures is necessary (and not otherwise duplicative), EPA should describe the process it used to consult with OSHA and the basis for its findings in the scope of the risk evaluation. 7/Page Source: https://www.industrydocuments.ucsf.edu/docs/kzbn0226 F. EPA Should Generally Exclude Low Exposure Conditions of Use from the Scopes of TSCA Risk Evaluations. In the prioritization process, certain scenarios may emerge that are low- - to no-exposure. An example is a closed system, intermediate chemical manufacture or processing at an industrial site, where worker exposure is well documented and controlled, and does not present a significant risk. A second example would be de minimis levels of an impurity in a consumer product, where the levels and variability are well documented and well understood, and exposures are so low as not to present a significant risk. In such cases, it should be apparent in the prioritization process or before scoping that these use scenarios can readily be excluded from the scope of the risk evaluation. G. EPA Should Apply the "Reasonably Foreseen" Provision as a Focusing Tool to Help Tailor the Scope of Risk Evaluations - Not to Expand Them. The statutory definition of "conditions of use" is "the circumstances, as determined by the Administrator, under which a chemical substances is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used or disposed of.">10 The phrase "intended, known, or reasonably foreseen" limits the conditions of use that may be identified and included in a scope. Clearly, if a particular use is not intended, known, or reasonably foreseen, it is not a statutory "condition of use" and may not be included within the scope of a risk evaluation. The term "intended" is generally well understood to mean intended by the manufacturer or processor. Intention can be demonstrated through express (e.g., a statement to that effect in a premanufacture notice) or implied evidence (e.g., marketing materials that imply a potential application for the chemical). The term "known" is often considered a backstop for the term "intended," in that manufacturers or processors may not "intend" or support a particular downstream use for a chemical but may have actual or imputed knowledge that a chemical is being used in that application. The definition of "conditions of use" also includes the term "reasonably foreseen." The concept of reasonable foreseeability is well understood in American and western11 tort law. Foreseeability is "the determinant for the limits of duty under a conventional risk analysis" [emphasis added]. Foreseeability is modified by "reasonably," which makes clear that not 12 every conceivable or speculative use is included. Product misuses and illegal uses, and manufacturing that disregards legal and industrial hygiene requirements, are not "reasonable" and thus not "reasonably foreseen." 10 TSCA §3(4). 11 See, e.g., ANNEXURE T, The Concept of Limited Liability, Existing Law and Rationale (Australia), referring to the limiting tests of reasonable foreseeability and proximity, available at htp:/lwww.dpc.nsw.gov.au data/assets/odf.file/0012/11406/T.pdi 12 Tyrus V. Dahl Jr., Strict Products Liability: The Irrelevance of Foreseeability and Related Negligence Concepts, 14 Tulsa L. J. 338, 343 (1978). 8/Page Source: https://www.industrydocuments.ucsf.edu/docs/kzbn0226

which code is related to section 4181 tax is imposed?

kzbn0226

kzbn0226_p8, kzbn0226_p9, kzbn0226_p10, kzbn0226_p11, kzbn0226_p12

internal revenue code

At the same time, risk evaluations must meet Section 26 quality requirements, using best available science and weight of the evidence review. To achieve the throughput and quality requirements for risk evaluation, Congress designed a process to allow chemicals to be systematically prioritized and evaluated. This design is apparent throughout LCSA. It begins with a reset of the TSCA Inventory -- the full catalog of chemicals in commerce. LCSA requires that the TSCA Inventory be sorted, so that chemicals that are currently active in commerce are separated from those not currently used. This sorting enables EPA to identify only those chemicals that are active in commerce for prioritization and risk evaluation. This statutory design makes eminent sense: it allows EPA to focus resources for its multi-year, time- and resource-intensive risk evaluations on chemicals that are actually being used. From this initial focusing step, LCSA repeatedly requires EPA to further refine its focus throughout prioritization and risk evaluation. EPA must next implement a prioritization process, which further refines the active chemicals in commerce to those that are high priority for risk evaluation. These chemicals must then undergo a scoping exercise to further focus on the conditions of use that will be the subject of the risk evaluation. In implementing LCSA, EPA has indicated that it intends to identify and consider all conditions of use of a chemical in all risk evaluations, all the time. This interpretation cannot be reconciled with EPA's statutory directive to achieve throughput and quality in risk evaluations. It is inconsistent with the design of the statute; inconsistent with congressional intent to give EPA the flexibility to make case-by-case scoping decisions; and undermines statutory purposes and the effective function of the statute itself. A. There is No Statutory Mandate to Include All Conditions of Use in the Scope of Every Risk Evaluation Under TSCA § 6(b). EPA notes in the preamble that, prior to enactment of LCSA, the Agency was "free to and did" conduct risk assessments on selected uses of chemical substances, but that it now interprets the amended statute as "requiring that risk evaluations encompass all manufacture, processing, distribution in commerce, use, and disposal activities [t]hat is to say, a risk evaluation must encompass all known, intended, and reasonably foreseen activities associated with the subject chemical substance" [emphasis added]. ACC strongly disagrees with this interpretation -- EPA 3 is reading a mandate into the statute where none exists. Rather, Congress equipped EPA with the tools to scope risk evaluations in order to achieve statutory purposes, and EPA should use those tools accordingly. The statute does not require EPA to include "all" conditions of use in any particular risk evaluation, or in each and every risk evaluation. Nowhere in the statute does Congress modify "conditions of use" with "all." EPA has the discretion to interpret the term. It cannot apply this discretion in such a manner, however, as to undercut the operation of the statute or to make it impossible for EPA to meet its statutory objectives of throughput and quality. 3 82 Fed. Reg. at 7565. 4/Page Source: https://www.industrydocuments.ucsf.edu/docs/kzbn0226 B. Scoping Necessarily Requires EPA to Select Relevant Conditions of Use for Inclusion, and Scope Accordingly. LCSA requires EPA to conduct risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment under certain circumstances called "conditions of use. ,,4 Conditions of use are defined as "the circumstances, as determined by [EPA], under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of." The legislative text did not direct EPA to include "all" conditions of use. The statute creates a scoping process that precedes the risk evaluation itself. For a scoping process to have any reasonable meaning, it must actually "scope" -- on a case by case basis, it must determine which conditions of use are appropriate for inclusion because they are relevant and meaningful to the risk evaluation process. EPA's plan to universally include "all conditions of use" all the time in every risk evaluation is contrary to common sense, conflicts with and undermines the statutory design of TSCA as amended by LCSA, and would lead to an absurd result. 5 EPA's preamble acknowledges the value of scoping (also called problem formulation) in citing the National Academy of Sciences (NAS) National Research Council (NRC) Science and Decisions Report. The NAS report recommended that EPA focus on the "important roles of scoping or problem formulation so that a risk assessment will serve a specific and documented purpose" [emphasis added]. The preamble cites an additional NAS recommendation to EPA 6 that the Agency "develop risk assessments that are well-tailored to the problems and decisions at hand so that they can inform the decision-making process in the most meaningful way." We agree, and urge the agency to apply these recommendations to the scoping process. C. The Legislative Text Acknowledges that What EPA Will Consider and Include in a Given Scope Necessarily Varies. The scoping provision requires identification of those conditions EPA "expects to consider," a clause that would be unnecessary if EPA were directed to simply include "all" conditions of use in a risk evaluation. The future tense also acknowledges that EPA might subsequently change 8 4 TSCA § 6(b)(4)(A). 5 See Massachusetts v. EPA, 549 U.S. 497, 531, 535 (2007) addressing EPA's application of its Chevron deference to particular statutory constructions: EPA not required to regulate "all" greenhouse gases as "air pollutants" everywhere that term appears in the statute; EPA must ground its reasons for action or inaction in the statute; agency regulation cannot conflict with statutory design, and law cannot be read to compel EPA to regulate in a manner contrary to "common sense." 6 82 Fed. Reg. at 7265. 7 TSCA § 6(b)(3)(D). 8 Before LCSA was enacted, EPA had published multiple problem formulations under the TSCA Work Plan. EPA explained that its problem formulations served as a means for explaining the scope of a risk assessment: "A problem formulation and initial assessment document will serve to inform the public and other interested stakeholders about EPA's initial scoping of findings and plan for any further risk assessment. Problem formulation and initial assessment is the analytical phase of the assessment in which the purpose for the assessment is articulated, the problem defined and a plan for analyzing and characterizing risk is determined." Many of those completed problem formulations were for limited conditions of use. Like other aspects of the TSCA Work Plan, Congress 5/Page Source: https://www.industrydocuments.ucsf.edu/docs/kzbn0226 its position with respect to what conditions of use to include or exclude. Notably, this construction affords EPA the discretion to include all conditions of use where necessary. This is consistent with congressional intent. Speaking about the compromise bill that was signed into law, Senator Vitter said that EPA "is given the discretion to determine the conditions of use that the Agency will address in its evaluation of the priority chemical." This discretion and flexibility "assures that the Agency's focus is on conditions of use that raise the greatest potential for risk" particularly given that "many TSCA chemicals have multiple uses - industrial, commercial and consumer uses" and EPA is "well aware that some categories of uses pose greater potential for exposure than others and that the risks from many categories of uses are deemed negligible or already well controlled."9 D. EPA Should Expressly Exclude Substances that Are Not Regulated Under TSCA from the Scope of Risk Evaluations. TSCA excludes a number of chemical categories from its statutory scope. LCSA did not change these; accordingly, these categories should not be considered for inclusion in any risk evaluation undertaken pursuant to Section 6: (i) [a]ny mixture, (ii) any pesticide (as defined in the Federal Insecticide, Fungicide, and Rodenticide Act) when manufactured, processed, or distributed in commerce for use as a pesticide; (iii) tobacco or any tobacco product, (iv) any source material, special nuclear material, or byproduct material (as such terms are defined in the Atomic Energy Act of 1954 and regulations issued under such Act), (v) any article the sale of which is subject to the tax imposed by section 4181 of the Internal Revenue Code of 1986 [i.e., firearms and ammunition] (vi) any food, food additive, drug, cosmetic, or device (as such terms are defined in section 201 of the Federal Food, Drug, and Cosmetic Act) when manufactured, processed, or distributed in commerce for use as a food, food additive, drug, cosmetic, or device. The risk evaluation rule should expressly clarify that because these categories are excluded from the definition of "chemical substance" under TSCA, and they are outside EPA's legislative authority to regulate, they therefore excluded from the scope of risk evaluations under Section 6. contemplated that problem formulations from the TSCA Work Plan would serve as the model for EPA actions under the amended TSCA. In this case, the problem formulations were to be the model for the scoping exercise under Section 6(b)(4)(D). This is a strong indication that Congress authorized EPA to determine which conditions of use it would evaluate in a risk evaluation by defining the scope appropriately. 9 Senate Congressional Record, June 7, 2016, at S3519; available at also clarifies that unreasonable risk/no unreasonable risk determinations made pursuant to the risk evaluation are made use-by-use: "[T]o be clear, every condition of use identified by the Administrator in the scope of the risk evaluation must, and will be either found to present or not present an unreasonable risk." Id. at S3520. 6/Page Source: https://www.industrydocuments.ucsf.edu/docs/kzbn0226 Likewise, the rule should clarify that chemical uses within these exclusions are "conditions of use" that are outside the scope of any Section 6 risk evaluation. In addition to TSCA, which was modernized by the passage of LCSA in 2016, there is a network of statutes in place regulating the safety of chemicals in various venues and applications. Several other federal statutes are in place to regulate chemicals in products and during activities such as workplace manufacturing. Notably, the Consumer Protection Act, Consumer Product Safety Improvement Act, and the Federal Hazardous Substances Act regulate chemicals in a suite of consumer products, including children's products and toys, and the Occupational Safety and Health Act (OSH Act) regulates chemicals in the workplace. Chemicals in uses regulated by other federal laws and agencies are often referred to as "non- TSCA" uses. EPA should not include these uses in its risk evaluations under TSCA. In rare cases where inclusion might be justified, the Agency should establish criteria to justify including non-TSCA uses in its risk evaluations and should articulate the steps it will follow to ensure adequate interagency consultation and review at the scoping stage. We discuss this topic in more detail below. E. EPA Should Generally Exclude OSHA-Regulated Uses from the Scopes of TSCA Risk Evaluations. Although LCSA specifically includes "workers" as a possible category of "potentially exposed or susceptible subpopulation," it does not designate "workers" as a default category. Any consideration of worker exposure must begin with the recognition that worker exposures are regulated under the OSH Act. Given that Occupational Safety and Health Administration (OSHA) standards are in place for the very purpose of regulating risk to worker populations, it should be the unusual case where unreasonable risk may present to a worker population under conditions of use (e.g., use of personal protective equipment). Importantly, although Congress recognizes under LCSA that it may be appropriate, under particular circumstances, for EPA to designate workers as a potentially exposed or susceptible subpopulation under TSCA, and to regulate workplace exposures, Congress did not amend the OSH Act at the same time that it amended TSCA. Congress also left Section 9(d) of TSCA intact. This section requires EPA to consult and coordinate with OSHA "for the purpose of achieving the maximum enforcement of [TSCA] while imposing the least burdens of duplicative requirements on those subject to [TSCA] and for other purposes.' EPA should ensure that this consultation occurs before risk evaluations are scoped; in cases where worker exposures do not present a significant risk of health impairment under current conditions of use, EPA should decline to include worker populations within the scope of the risk assessment as unduly burdensome and duplicative. This process will help focus risk evaluations and reduce the resource cost to the Agency. Following this consultation, if OSHA agrees that EPA-led risk evaluation considering worker exposures is necessary (and not otherwise duplicative), EPA should describe the process it used to consult with OSHA and the basis for its findings in the scope of the risk evaluation. 7/Page Source: https://www.industrydocuments.ucsf.edu/docs/kzbn0226 F. EPA Should Generally Exclude Low Exposure Conditions of Use from the Scopes of TSCA Risk Evaluations. In the prioritization process, certain scenarios may emerge that are low- - to no-exposure. An example is a closed system, intermediate chemical manufacture or processing at an industrial site, where worker exposure is well documented and controlled, and does not present a significant risk. A second example would be de minimis levels of an impurity in a consumer product, where the levels and variability are well documented and well understood, and exposures are so low as not to present a significant risk. In such cases, it should be apparent in the prioritization process or before scoping that these use scenarios can readily be excluded from the scope of the risk evaluation. G. EPA Should Apply the "Reasonably Foreseen" Provision as a Focusing Tool to Help Tailor the Scope of Risk Evaluations - Not to Expand Them. The statutory definition of "conditions of use" is "the circumstances, as determined by the Administrator, under which a chemical substances is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used or disposed of.">10 The phrase "intended, known, or reasonably foreseen" limits the conditions of use that may be identified and included in a scope. Clearly, if a particular use is not intended, known, or reasonably foreseen, it is not a statutory "condition of use" and may not be included within the scope of a risk evaluation. The term "intended" is generally well understood to mean intended by the manufacturer or processor. Intention can be demonstrated through express (e.g., a statement to that effect in a premanufacture notice) or implied evidence (e.g., marketing materials that imply a potential application for the chemical). The term "known" is often considered a backstop for the term "intended," in that manufacturers or processors may not "intend" or support a particular downstream use for a chemical but may have actual or imputed knowledge that a chemical is being used in that application. The definition of "conditions of use" also includes the term "reasonably foreseen." The concept of reasonable foreseeability is well understood in American and western11 tort law. Foreseeability is "the determinant for the limits of duty under a conventional risk analysis" [emphasis added]. Foreseeability is modified by "reasonably," which makes clear that not 12 every conceivable or speculative use is included. Product misuses and illegal uses, and manufacturing that disregards legal and industrial hygiene requirements, are not "reasonable" and thus not "reasonably foreseen." 10 TSCA §3(4). 11 See, e.g., ANNEXURE T, The Concept of Limited Liability, Existing Law and Rationale (Australia), referring to the limiting tests of reasonable foreseeability and proximity, available at htp:/lwww.dpc.nsw.gov.au data/assets/odf.file/0012/11406/T.pdi 12 Tyrus V. Dahl Jr., Strict Products Liability: The Irrelevance of Foreseeability and Related Negligence Concepts, 14 Tulsa L. J. 338, 343 (1978). 8/Page Source: https://www.industrydocuments.ucsf.edu/docs/kzbn0226

which excludes a number of chemical categories from its statutory scope?

kzbn0226

kzbn0226_p8, kzbn0226_p9, kzbn0226_p10, kzbn0226_p11, kzbn0226_p12

TSCA

At the same time, risk evaluations must meet Section 26 quality requirements, using best available science and weight of the evidence review. To achieve the throughput and quality requirements for risk evaluation, Congress designed a process to allow chemicals to be systematically prioritized and evaluated. This design is apparent throughout LCSA. It begins with a reset of the TSCA Inventory -- the full catalog of chemicals in commerce. LCSA requires that the TSCA Inventory be sorted, so that chemicals that are currently active in commerce are separated from those not currently used. This sorting enables EPA to identify only those chemicals that are active in commerce for prioritization and risk evaluation. This statutory design makes eminent sense: it allows EPA to focus resources for its multi-year, time- and resource-intensive risk evaluations on chemicals that are actually being used. From this initial focusing step, LCSA repeatedly requires EPA to further refine its focus throughout prioritization and risk evaluation. EPA must next implement a prioritization process, which further refines the active chemicals in commerce to those that are high priority for risk evaluation. These chemicals must then undergo a scoping exercise to further focus on the conditions of use that will be the subject of the risk evaluation. In implementing LCSA, EPA has indicated that it intends to identify and consider all conditions of use of a chemical in all risk evaluations, all the time. This interpretation cannot be reconciled with EPA's statutory directive to achieve throughput and quality in risk evaluations. It is inconsistent with the design of the statute; inconsistent with congressional intent to give EPA the flexibility to make case-by-case scoping decisions; and undermines statutory purposes and the effective function of the statute itself. A. There is No Statutory Mandate to Include All Conditions of Use in the Scope of Every Risk Evaluation Under TSCA § 6(b). EPA notes in the preamble that, prior to enactment of LCSA, the Agency was "free to and did" conduct risk assessments on selected uses of chemical substances, but that it now interprets the amended statute as "requiring that risk evaluations encompass all manufacture, processing, distribution in commerce, use, and disposal activities [t]hat is to say, a risk evaluation must encompass all known, intended, and reasonably foreseen activities associated with the subject chemical substance" [emphasis added]. ACC strongly disagrees with this interpretation -- EPA 3 is reading a mandate into the statute where none exists. Rather, Congress equipped EPA with the tools to scope risk evaluations in order to achieve statutory purposes, and EPA should use those tools accordingly. The statute does not require EPA to include "all" conditions of use in any particular risk evaluation, or in each and every risk evaluation. Nowhere in the statute does Congress modify "conditions of use" with "all." EPA has the discretion to interpret the term. It cannot apply this discretion in such a manner, however, as to undercut the operation of the statute or to make it impossible for EPA to meet its statutory objectives of throughput and quality. 3 82 Fed. Reg. at 7565. 4/Page Source: https://www.industrydocuments.ucsf.edu/docs/kzbn0226 B. Scoping Necessarily Requires EPA to Select Relevant Conditions of Use for Inclusion, and Scope Accordingly. LCSA requires EPA to conduct risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment under certain circumstances called "conditions of use. ,,4 Conditions of use are defined as "the circumstances, as determined by [EPA], under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of." The legislative text did not direct EPA to include "all" conditions of use. The statute creates a scoping process that precedes the risk evaluation itself. For a scoping process to have any reasonable meaning, it must actually "scope" -- on a case by case basis, it must determine which conditions of use are appropriate for inclusion because they are relevant and meaningful to the risk evaluation process. EPA's plan to universally include "all conditions of use" all the time in every risk evaluation is contrary to common sense, conflicts with and undermines the statutory design of TSCA as amended by LCSA, and would lead to an absurd result. 5 EPA's preamble acknowledges the value of scoping (also called problem formulation) in citing the National Academy of Sciences (NAS) National Research Council (NRC) Science and Decisions Report. The NAS report recommended that EPA focus on the "important roles of scoping or problem formulation so that a risk assessment will serve a specific and documented purpose" [emphasis added]. The preamble cites an additional NAS recommendation to EPA 6 that the Agency "develop risk assessments that are well-tailored to the problems and decisions at hand so that they can inform the decision-making process in the most meaningful way." We agree, and urge the agency to apply these recommendations to the scoping process. C. The Legislative Text Acknowledges that What EPA Will Consider and Include in a Given Scope Necessarily Varies. The scoping provision requires identification of those conditions EPA "expects to consider," a clause that would be unnecessary if EPA were directed to simply include "all" conditions of use in a risk evaluation. The future tense also acknowledges that EPA might subsequently change 8 4 TSCA § 6(b)(4)(A). 5 See Massachusetts v. EPA, 549 U.S. 497, 531, 535 (2007) addressing EPA's application of its Chevron deference to particular statutory constructions: EPA not required to regulate "all" greenhouse gases as "air pollutants" everywhere that term appears in the statute; EPA must ground its reasons for action or inaction in the statute; agency regulation cannot conflict with statutory design, and law cannot be read to compel EPA to regulate in a manner contrary to "common sense." 6 82 Fed. Reg. at 7265. 7 TSCA § 6(b)(3)(D). 8 Before LCSA was enacted, EPA had published multiple problem formulations under the TSCA Work Plan. EPA explained that its problem formulations served as a means for explaining the scope of a risk assessment: "A problem formulation and initial assessment document will serve to inform the public and other interested stakeholders about EPA's initial scoping of findings and plan for any further risk assessment. Problem formulation and initial assessment is the analytical phase of the assessment in which the purpose for the assessment is articulated, the problem defined and a plan for analyzing and characterizing risk is determined." Many of those completed problem formulations were for limited conditions of use. Like other aspects of the TSCA Work Plan, Congress 5/Page Source: https://www.industrydocuments.ucsf.edu/docs/kzbn0226 its position with respect to what conditions of use to include or exclude. Notably, this construction affords EPA the discretion to include all conditions of use where necessary. This is consistent with congressional intent. Speaking about the compromise bill that was signed into law, Senator Vitter said that EPA "is given the discretion to determine the conditions of use that the Agency will address in its evaluation of the priority chemical." This discretion and flexibility "assures that the Agency's focus is on conditions of use that raise the greatest potential for risk" particularly given that "many TSCA chemicals have multiple uses - industrial, commercial and consumer uses" and EPA is "well aware that some categories of uses pose greater potential for exposure than others and that the risks from many categories of uses are deemed negligible or already well controlled."9 D. EPA Should Expressly Exclude Substances that Are Not Regulated Under TSCA from the Scope of Risk Evaluations. TSCA excludes a number of chemical categories from its statutory scope. LCSA did not change these; accordingly, these categories should not be considered for inclusion in any risk evaluation undertaken pursuant to Section 6: (i) [a]ny mixture, (ii) any pesticide (as defined in the Federal Insecticide, Fungicide, and Rodenticide Act) when manufactured, processed, or distributed in commerce for use as a pesticide; (iii) tobacco or any tobacco product, (iv) any source material, special nuclear material, or byproduct material (as such terms are defined in the Atomic Energy Act of 1954 and regulations issued under such Act), (v) any article the sale of which is subject to the tax imposed by section 4181 of the Internal Revenue Code of 1986 [i.e., firearms and ammunition] (vi) any food, food additive, drug, cosmetic, or device (as such terms are defined in section 201 of the Federal Food, Drug, and Cosmetic Act) when manufactured, processed, or distributed in commerce for use as a food, food additive, drug, cosmetic, or device. The risk evaluation rule should expressly clarify that because these categories are excluded from the definition of "chemical substance" under TSCA, and they are outside EPA's legislative authority to regulate, they therefore excluded from the scope of risk evaluations under Section 6. contemplated that problem formulations from the TSCA Work Plan would serve as the model for EPA actions under the amended TSCA. In this case, the problem formulations were to be the model for the scoping exercise under Section 6(b)(4)(D). This is a strong indication that Congress authorized EPA to determine which conditions of use it would evaluate in a risk evaluation by defining the scope appropriately. 9 Senate Congressional Record, June 7, 2016, at S3519; available at also clarifies that unreasonable risk/no unreasonable risk determinations made pursuant to the risk evaluation are made use-by-use: "[T]o be clear, every condition of use identified by the Administrator in the scope of the risk evaluation must, and will be either found to present or not present an unreasonable risk." Id. at S3520. 6/Page Source: https://www.industrydocuments.ucsf.edu/docs/kzbn0226 Likewise, the rule should clarify that chemical uses within these exclusions are "conditions of use" that are outside the scope of any Section 6 risk evaluation. In addition to TSCA, which was modernized by the passage of LCSA in 2016, there is a network of statutes in place regulating the safety of chemicals in various venues and applications. Several other federal statutes are in place to regulate chemicals in products and during activities such as workplace manufacturing. Notably, the Consumer Protection Act, Consumer Product Safety Improvement Act, and the Federal Hazardous Substances Act regulate chemicals in a suite of consumer products, including children's products and toys, and the Occupational Safety and Health Act (OSH Act) regulates chemicals in the workplace. Chemicals in uses regulated by other federal laws and agencies are often referred to as "non- TSCA" uses. EPA should not include these uses in its risk evaluations under TSCA. In rare cases where inclusion might be justified, the Agency should establish criteria to justify including non-TSCA uses in its risk evaluations and should articulate the steps it will follow to ensure adequate interagency consultation and review at the scoping stage. We discuss this topic in more detail below. E. EPA Should Generally Exclude OSHA-Regulated Uses from the Scopes of TSCA Risk Evaluations. Although LCSA specifically includes "workers" as a possible category of "potentially exposed or susceptible subpopulation," it does not designate "workers" as a default category. Any consideration of worker exposure must begin with the recognition that worker exposures are regulated under the OSH Act. Given that Occupational Safety and Health Administration (OSHA) standards are in place for the very purpose of regulating risk to worker populations, it should be the unusual case where unreasonable risk may present to a worker population under conditions of use (e.g., use of personal protective equipment). Importantly, although Congress recognizes under LCSA that it may be appropriate, under particular circumstances, for EPA to designate workers as a potentially exposed or susceptible subpopulation under TSCA, and to regulate workplace exposures, Congress did not amend the OSH Act at the same time that it amended TSCA. Congress also left Section 9(d) of TSCA intact. This section requires EPA to consult and coordinate with OSHA "for the purpose of achieving the maximum enforcement of [TSCA] while imposing the least burdens of duplicative requirements on those subject to [TSCA] and for other purposes.' EPA should ensure that this consultation occurs before risk evaluations are scoped; in cases where worker exposures do not present a significant risk of health impairment under current conditions of use, EPA should decline to include worker populations within the scope of the risk assessment as unduly burdensome and duplicative. This process will help focus risk evaluations and reduce the resource cost to the Agency. Following this consultation, if OSHA agrees that EPA-led risk evaluation considering worker exposures is necessary (and not otherwise duplicative), EPA should describe the process it used to consult with OSHA and the basis for its findings in the scope of the risk evaluation. 7/Page Source: https://www.industrydocuments.ucsf.edu/docs/kzbn0226 F. EPA Should Generally Exclude Low Exposure Conditions of Use from the Scopes of TSCA Risk Evaluations. In the prioritization process, certain scenarios may emerge that are low- - to no-exposure. An example is a closed system, intermediate chemical manufacture or processing at an industrial site, where worker exposure is well documented and controlled, and does not present a significant risk. A second example would be de minimis levels of an impurity in a consumer product, where the levels and variability are well documented and well understood, and exposures are so low as not to present a significant risk. In such cases, it should be apparent in the prioritization process or before scoping that these use scenarios can readily be excluded from the scope of the risk evaluation. G. EPA Should Apply the "Reasonably Foreseen" Provision as a Focusing Tool to Help Tailor the Scope of Risk Evaluations - Not to Expand Them. The statutory definition of "conditions of use" is "the circumstances, as determined by the Administrator, under which a chemical substances is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used or disposed of.">10 The phrase "intended, known, or reasonably foreseen" limits the conditions of use that may be identified and included in a scope. Clearly, if a particular use is not intended, known, or reasonably foreseen, it is not a statutory "condition of use" and may not be included within the scope of a risk evaluation. The term "intended" is generally well understood to mean intended by the manufacturer or processor. Intention can be demonstrated through express (e.g., a statement to that effect in a premanufacture notice) or implied evidence (e.g., marketing materials that imply a potential application for the chemical). The term "known" is often considered a backstop for the term "intended," in that manufacturers or processors may not "intend" or support a particular downstream use for a chemical but may have actual or imputed knowledge that a chemical is being used in that application. The definition of "conditions of use" also includes the term "reasonably foreseen." The concept of reasonable foreseeability is well understood in American and western11 tort law. Foreseeability is "the determinant for the limits of duty under a conventional risk analysis" [emphasis added]. Foreseeability is modified by "reasonably," which makes clear that not 12 every conceivable or speculative use is included. Product misuses and illegal uses, and manufacturing that disregards legal and industrial hygiene requirements, are not "reasonable" and thus not "reasonably foreseen." 10 TSCA §3(4). 11 See, e.g., ANNEXURE T, The Concept of Limited Liability, Existing Law and Rationale (Australia), referring to the limiting tests of reasonable foreseeability and proximity, available at htp:/lwww.dpc.nsw.gov.au data/assets/odf.file/0012/11406/T.pdi 12 Tyrus V. Dahl Jr., Strict Products Liability: The Irrelevance of Foreseeability and Related Negligence Concepts, 14 Tulsa L. J. 338, 343 (1978). 8/Page Source: https://www.industrydocuments.ucsf.edu/docs/kzbn0226

What does APA stands for?

jzbn0226

jzbn0226_p24, jzbn0226_p25, jzbn0226_p26

ADMINISTRATIVE PROCEDURES ACT, Administrative procedures act

C. Waivers EPA has proposed that all comments that could be raised on issues in a proposed low priority designation be presented during the comment period, and that any issues not raised then be considered to have been waived. Waived issues could not form the basis of an objection or challenge in any subsequent administrative or judicial proceeding on the designation of the substance as a low priority substance (which is subject to judicial review). EPA points to the statutory deadlines in the prioritization process as the policy justification for this proposal. 38 ACC urges EPA to remove this waiver requirement from the prioritization rule. First, it is inconsistent with Congress's intent that the prioritization process be iterative and science-based. Low priority designations should be able to be modified - expanded or contracted - based on new information that is brought to the Agency's attention after the designation. This new information might not have been known during the public comment period on the low priority designation. It would be bad public policy to consider new information waived because that could discourage stakeholders from gathering or developing relevant information about a chemical. Second, participation in the notice and comment rulemaking process of prioritization is governed by statute - through the Administrative Procedures Act (APA) and the judicial review provisions of Section 19 of TSCA. There are no issue exhaustion provisions in TSCA. EPA cannot by regulation, impose an issue exhaustion requirement that trumps the statutory rights and obligations of stakeholders under the APA and TSCA Section 19.39 D. Definitions As an addendum to ACC's recommendations for EPA to reference the Section 26 science standards in the prioritization process rule, ACC offers the following definitions for EPA's consideration: Best available science means information that has been evaluated based on its strengths, limitations and relevance and the Agency is relying on the highest quality information. In evaluating best available science the Agency will also consider the peer review of the science, whether the study was conducted in accordance with sound and objective practices, and if the data were collected by accepted methods or best available methods. To ensure transparency regarding best available science the Agency will describe and document any assumptions and methods used, and address variability, uncertainty, the degree of independent verification and peer review. Weight of the evidence means a systematic review method that uses a pre-established protocol to comprehensively, objectively, transparently, and consistently, identify and evaluate each stream of evidence, including strengths, limitations, and relevance of each study and to integrate evidence as necessary and appropriate based upon strengths, limitations, and relevance. 38 Id. at 4833. 39 See ACC Comments on EPA's Proposed Rule: Procedures for Chemical Risk Evaluation under the Amended Toxic Substances Control Act (RIN 2070- AK20) for additional discussion of the waiver/lock down/issue exhaustion issue. 23 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 E. Repopulation of High Priority Substances EPA's preamble discussion of the "repopulation" of high priority substances40 presents a reasonable approach by which the Agency could meet the LCSA obligation to finalize the designation of one new high priority substance upon completion of a risk evaluation for another substance. The one-for-one approach makes sense as this program gets underway. ACC suggests, however, that EPA consider a placeholder in its rule to anticipate changes in the rate at which EPA might be able to conduct risk evaluations over time (based on use of 21st Century tools and methods) and hence potentially change the rate at which EPA may need to designate high priorities for risk evaluation. VIII. Summary of ACC's Recommendations: Throughout these comments, ACC has included many specific recommendations for EPA to consider as it develops its final prioritization process rule to address ACC's concerns about the proposed rule. These recommendations urge EPA to direct its authority on what it is mandated to do under the LCSA - designate high priority and low priority chemicals for risk evaluations in accordance with both the criteria in LCSA Section 6 and the LCSA Section 26 science based standards. To help the regulated community provide EPA the information the Agency will need to prioritize chemicals for risk evaluations, EPA must clarify the prioritization process as a whole and develop an efficient and focused prioritization process rule that meets the LCSA mandate and Congressional intent. ACC strongly urges EPA to amend its proposal to include these suggested recommendations and seek public comment before finalizing the prioritization process rule. Alternatively, EPA should propose a supplemental rule providing more detail and clarifications on the prioritization process steps involved and finalize it prior to the Agency's first application of the prioritization process . To help foster the submission of information needed to prioritize chemicals for risk evaluations, EPA must ultimately develop an efficient and focused prioritization process rule that clearly lays out the major steps for meeting its mandate. 40 82 Fed. Reg. at 4833. 24 Source: :ttps://www.industrydocuments.ucsf.edu/docs/jzbn0226 Attachment A ACC's General Principles on Prioritization (Developed for EPA Dialogue 7-2011) EPA should systematically prioritize chemicals for purposes of safe use determinations. As a general matter, prioritization should be based on existing hazard and exposure data and information (including models, read across, QSAR, etc.) and industry should be responsible for providing EPA with this data and information. Chemicals lacking adequate hazard and exposure information should be considered a higher priority (until relevant information is provided that suggests otherwise). Industry should be provided an opportunity to provide EPA additional data/information. (Timing is an issue, however. And the format in which the information is provided to EPA must be useable/digestible by EPA, e.g. robust summaries.) Hazard, use and exposure based criteria should be integrated to form the basis for EPA's prioritization decisions. Prioritization should not be based on either hazard-only or exposure-only information. The prioritization process and science based criteria that EPA uses to prioritize chemicals must be transparent. Prioritization should be a dynamic, iterative process. Re-examination of priorities should occur as new information becomes available and as new chemicals are approved for manufacturing. For prioritization to be successful, it must include three critical elements: reliable and up- to- date chemical data and information; evaluation criteria that consider both hazard and exposure information together; and established cutoffs to make priority decisions. EPA's communication about priority chemicals must be clear about what the list is and what it is not, to avoid unintended consequences of product de-selection purely on the basis of listing. Transparency; consistent, scientific criteria; intersection of both hazard and exposure information; dynamic process so new information can be incorporated as it is made available and so if priorities are initially "wrong" they can be corrected. 25 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226

which urges EPA to remove this wavier requirement from the prioritisation rule ?

jzbn0226

jzbn0226_p24, jzbn0226_p25, jzbn0226_p26

ACC

C. Waivers EPA has proposed that all comments that could be raised on issues in a proposed low priority designation be presented during the comment period, and that any issues not raised then be considered to have been waived. Waived issues could not form the basis of an objection or challenge in any subsequent administrative or judicial proceeding on the designation of the substance as a low priority substance (which is subject to judicial review). EPA points to the statutory deadlines in the prioritization process as the policy justification for this proposal. 38 ACC urges EPA to remove this waiver requirement from the prioritization rule. First, it is inconsistent with Congress's intent that the prioritization process be iterative and science-based. Low priority designations should be able to be modified - expanded or contracted - based on new information that is brought to the Agency's attention after the designation. This new information might not have been known during the public comment period on the low priority designation. It would be bad public policy to consider new information waived because that could discourage stakeholders from gathering or developing relevant information about a chemical. Second, participation in the notice and comment rulemaking process of prioritization is governed by statute - through the Administrative Procedures Act (APA) and the judicial review provisions of Section 19 of TSCA. There are no issue exhaustion provisions in TSCA. EPA cannot by regulation, impose an issue exhaustion requirement that trumps the statutory rights and obligations of stakeholders under the APA and TSCA Section 19.39 D. Definitions As an addendum to ACC's recommendations for EPA to reference the Section 26 science standards in the prioritization process rule, ACC offers the following definitions for EPA's consideration: Best available science means information that has been evaluated based on its strengths, limitations and relevance and the Agency is relying on the highest quality information. In evaluating best available science the Agency will also consider the peer review of the science, whether the study was conducted in accordance with sound and objective practices, and if the data were collected by accepted methods or best available methods. To ensure transparency regarding best available science the Agency will describe and document any assumptions and methods used, and address variability, uncertainty, the degree of independent verification and peer review. Weight of the evidence means a systematic review method that uses a pre-established protocol to comprehensively, objectively, transparently, and consistently, identify and evaluate each stream of evidence, including strengths, limitations, and relevance of each study and to integrate evidence as necessary and appropriate based upon strengths, limitations, and relevance. 38 Id. at 4833. 39 See ACC Comments on EPA's Proposed Rule: Procedures for Chemical Risk Evaluation under the Amended Toxic Substances Control Act (RIN 2070- AK20) for additional discussion of the waiver/lock down/issue exhaustion issue. 23 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 E. Repopulation of High Priority Substances EPA's preamble discussion of the "repopulation" of high priority substances40 presents a reasonable approach by which the Agency could meet the LCSA obligation to finalize the designation of one new high priority substance upon completion of a risk evaluation for another substance. The one-for-one approach makes sense as this program gets underway. ACC suggests, however, that EPA consider a placeholder in its rule to anticipate changes in the rate at which EPA might be able to conduct risk evaluations over time (based on use of 21st Century tools and methods) and hence potentially change the rate at which EPA may need to designate high priorities for risk evaluation. VIII. Summary of ACC's Recommendations: Throughout these comments, ACC has included many specific recommendations for EPA to consider as it develops its final prioritization process rule to address ACC's concerns about the proposed rule. These recommendations urge EPA to direct its authority on what it is mandated to do under the LCSA - designate high priority and low priority chemicals for risk evaluations in accordance with both the criteria in LCSA Section 6 and the LCSA Section 26 science based standards. To help the regulated community provide EPA the information the Agency will need to prioritize chemicals for risk evaluations, EPA must clarify the prioritization process as a whole and develop an efficient and focused prioritization process rule that meets the LCSA mandate and Congressional intent. ACC strongly urges EPA to amend its proposal to include these suggested recommendations and seek public comment before finalizing the prioritization process rule. Alternatively, EPA should propose a supplemental rule providing more detail and clarifications on the prioritization process steps involved and finalize it prior to the Agency's first application of the prioritization process . To help foster the submission of information needed to prioritize chemicals for risk evaluations, EPA must ultimately develop an efficient and focused prioritization process rule that clearly lays out the major steps for meeting its mandate. 40 82 Fed. Reg. at 4833. 24 Source: :ttps://www.industrydocuments.ucsf.edu/docs/jzbn0226 Attachment A ACC's General Principles on Prioritization (Developed for EPA Dialogue 7-2011) EPA should systematically prioritize chemicals for purposes of safe use determinations. As a general matter, prioritization should be based on existing hazard and exposure data and information (including models, read across, QSAR, etc.) and industry should be responsible for providing EPA with this data and information. Chemicals lacking adequate hazard and exposure information should be considered a higher priority (until relevant information is provided that suggests otherwise). Industry should be provided an opportunity to provide EPA additional data/information. (Timing is an issue, however. And the format in which the information is provided to EPA must be useable/digestible by EPA, e.g. robust summaries.) Hazard, use and exposure based criteria should be integrated to form the basis for EPA's prioritization decisions. Prioritization should not be based on either hazard-only or exposure-only information. The prioritization process and science based criteria that EPA uses to prioritize chemicals must be transparent. Prioritization should be a dynamic, iterative process. Re-examination of priorities should occur as new information becomes available and as new chemicals are approved for manufacturing. For prioritization to be successful, it must include three critical elements: reliable and up- to- date chemical data and information; evaluation criteria that consider both hazard and exposure information together; and established cutoffs to make priority decisions. EPA's communication about priority chemicals must be clear about what the list is and what it is not, to avoid unintended consequences of product de-selection purely on the basis of listing. Transparency; consistent, scientific criteria; intersection of both hazard and exposure information; dynamic process so new information can be incorporated as it is made available and so if priorities are initially "wrong" they can be corrected. 25 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226

what should be able to be modified-expanded or contracted ?

jzbn0226

jzbn0226_p24, jzbn0226_p25, jzbn0226_p26

low priority designations

C. Waivers EPA has proposed that all comments that could be raised on issues in a proposed low priority designation be presented during the comment period, and that any issues not raised then be considered to have been waived. Waived issues could not form the basis of an objection or challenge in any subsequent administrative or judicial proceeding on the designation of the substance as a low priority substance (which is subject to judicial review). EPA points to the statutory deadlines in the prioritization process as the policy justification for this proposal. 38 ACC urges EPA to remove this waiver requirement from the prioritization rule. First, it is inconsistent with Congress's intent that the prioritization process be iterative and science-based. Low priority designations should be able to be modified - expanded or contracted - based on new information that is brought to the Agency's attention after the designation. This new information might not have been known during the public comment period on the low priority designation. It would be bad public policy to consider new information waived because that could discourage stakeholders from gathering or developing relevant information about a chemical. Second, participation in the notice and comment rulemaking process of prioritization is governed by statute - through the Administrative Procedures Act (APA) and the judicial review provisions of Section 19 of TSCA. There are no issue exhaustion provisions in TSCA. EPA cannot by regulation, impose an issue exhaustion requirement that trumps the statutory rights and obligations of stakeholders under the APA and TSCA Section 19.39 D. Definitions As an addendum to ACC's recommendations for EPA to reference the Section 26 science standards in the prioritization process rule, ACC offers the following definitions for EPA's consideration: Best available science means information that has been evaluated based on its strengths, limitations and relevance and the Agency is relying on the highest quality information. In evaluating best available science the Agency will also consider the peer review of the science, whether the study was conducted in accordance with sound and objective practices, and if the data were collected by accepted methods or best available methods. To ensure transparency regarding best available science the Agency will describe and document any assumptions and methods used, and address variability, uncertainty, the degree of independent verification and peer review. Weight of the evidence means a systematic review method that uses a pre-established protocol to comprehensively, objectively, transparently, and consistently, identify and evaluate each stream of evidence, including strengths, limitations, and relevance of each study and to integrate evidence as necessary and appropriate based upon strengths, limitations, and relevance. 38 Id. at 4833. 39 See ACC Comments on EPA's Proposed Rule: Procedures for Chemical Risk Evaluation under the Amended Toxic Substances Control Act (RIN 2070- AK20) for additional discussion of the waiver/lock down/issue exhaustion issue. 23 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 E. Repopulation of High Priority Substances EPA's preamble discussion of the "repopulation" of high priority substances40 presents a reasonable approach by which the Agency could meet the LCSA obligation to finalize the designation of one new high priority substance upon completion of a risk evaluation for another substance. The one-for-one approach makes sense as this program gets underway. ACC suggests, however, that EPA consider a placeholder in its rule to anticipate changes in the rate at which EPA might be able to conduct risk evaluations over time (based on use of 21st Century tools and methods) and hence potentially change the rate at which EPA may need to designate high priorities for risk evaluation. VIII. Summary of ACC's Recommendations: Throughout these comments, ACC has included many specific recommendations for EPA to consider as it develops its final prioritization process rule to address ACC's concerns about the proposed rule. These recommendations urge EPA to direct its authority on what it is mandated to do under the LCSA - designate high priority and low priority chemicals for risk evaluations in accordance with both the criteria in LCSA Section 6 and the LCSA Section 26 science based standards. To help the regulated community provide EPA the information the Agency will need to prioritize chemicals for risk evaluations, EPA must clarify the prioritization process as a whole and develop an efficient and focused prioritization process rule that meets the LCSA mandate and Congressional intent. ACC strongly urges EPA to amend its proposal to include these suggested recommendations and seek public comment before finalizing the prioritization process rule. Alternatively, EPA should propose a supplemental rule providing more detail and clarifications on the prioritization process steps involved and finalize it prior to the Agency's first application of the prioritization process . To help foster the submission of information needed to prioritize chemicals for risk evaluations, EPA must ultimately develop an efficient and focused prioritization process rule that clearly lays out the major steps for meeting its mandate. 40 82 Fed. Reg. at 4833. 24 Source: :ttps://www.industrydocuments.ucsf.edu/docs/jzbn0226 Attachment A ACC's General Principles on Prioritization (Developed for EPA Dialogue 7-2011) EPA should systematically prioritize chemicals for purposes of safe use determinations. As a general matter, prioritization should be based on existing hazard and exposure data and information (including models, read across, QSAR, etc.) and industry should be responsible for providing EPA with this data and information. Chemicals lacking adequate hazard and exposure information should be considered a higher priority (until relevant information is provided that suggests otherwise). Industry should be provided an opportunity to provide EPA additional data/information. (Timing is an issue, however. And the format in which the information is provided to EPA must be useable/digestible by EPA, e.g. robust summaries.) Hazard, use and exposure based criteria should be integrated to form the basis for EPA's prioritization decisions. Prioritization should not be based on either hazard-only or exposure-only information. The prioritization process and science based criteria that EPA uses to prioritize chemicals must be transparent. Prioritization should be a dynamic, iterative process. Re-examination of priorities should occur as new information becomes available and as new chemicals are approved for manufacturing. For prioritization to be successful, it must include three critical elements: reliable and up- to- date chemical data and information; evaluation criteria that consider both hazard and exposure information together; and established cutoffs to make priority decisions. EPA's communication about priority chemicals must be clear about what the list is and what it is not, to avoid unintended consequences of product de-selection purely on the basis of listing. Transparency; consistent, scientific criteria; intersection of both hazard and exposure information; dynamic process so new information can be incorporated as it is made available and so if priorities are initially "wrong" they can be corrected. 25 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226

mention the email Id of Dr. kimberly wise email id ?

ngcn0226

ngcn0226_p2

[email protected], [email protected]

John Cowden, Ph.D. Janice Lee, Ph.D. January 28, 2013 Page 3 mode of action and dose response will help EPA to 1) streamline the toxicological review process; 2) focus resources on evaluating the most relevant hazards and risks of inorganic arsenic; and 3) provide risk assessors and risk managers with the tools needed to most accurately characterize the nature and range of potential risks in populations throughout the U.S. Thank you for considering our comments and suggestions. We look forward to receiving EPA's revised scoping document. If we can provide additional information, or if you have any questions regarding our comments, please feel free to contact Dr. Kimberly Wise at Kimberly [email protected] or Dr. Nancy Beck at Nancy [email protected]. Sincerely, all Kimberly Wise, Ph.D. Nancy Beck, Ph.D., DABT Senior Director Senior Director ARASP Regulatory and Technical Affairs. cc: Vincent Cogliano, Ph.D. Ken Olden, Ph.D. Source: https://www.industrydocuments.ucsf.edu/docs/ngcn0226

who is senior director for ARASP in this letter?

ngcn0226

ngcn0226_p2

kimberly wise, Ph.D., KIMBERLY WISE

John Cowden, Ph.D. Janice Lee, Ph.D. January 28, 2013 Page 3 mode of action and dose response will help EPA to 1) streamline the toxicological review process; 2) focus resources on evaluating the most relevant hazards and risks of inorganic arsenic; and 3) provide risk assessors and risk managers with the tools needed to most accurately characterize the nature and range of potential risks in populations throughout the U.S. Thank you for considering our comments and suggestions. We look forward to receiving EPA's revised scoping document. If we can provide additional information, or if you have any questions regarding our comments, please feel free to contact Dr. Kimberly Wise at Kimberly [email protected] or Dr. Nancy Beck at Nancy [email protected]. Sincerely, all Kimberly Wise, Ph.D. Nancy Beck, Ph.D., DABT Senior Director Senior Director ARASP Regulatory and Technical Affairs. cc: Vincent Cogliano, Ph.D. Ken Olden, Ph.D. Source: https://www.industrydocuments.ucsf.edu/docs/ngcn0226

Mention the first name in the CC?

ngcn0226

ngcn0226_p2

VINCENT COGLIANO, vincent cogliano, Ph.D.

John Cowden, Ph.D. Janice Lee, Ph.D. January 28, 2013 Page 3 mode of action and dose response will help EPA to 1) streamline the toxicological review process; 2) focus resources on evaluating the most relevant hazards and risks of inorganic arsenic; and 3) provide risk assessors and risk managers with the tools needed to most accurately characterize the nature and range of potential risks in populations throughout the U.S. Thank you for considering our comments and suggestions. We look forward to receiving EPA's revised scoping document. If we can provide additional information, or if you have any questions regarding our comments, please feel free to contact Dr. Kimberly Wise at Kimberly [email protected] or Dr. Nancy Beck at Nancy [email protected]. Sincerely, all Kimberly Wise, Ph.D. Nancy Beck, Ph.D., DABT Senior Director Senior Director ARASP Regulatory and Technical Affairs. cc: Vincent Cogliano, Ph.D. Ken Olden, Ph.D. Source: https://www.industrydocuments.ucsf.edu/docs/ngcn0226

who is selected for an appointment in this letter?

npbn0226

npbn0226_p0, npbn0226_p1

Nancy beck, nancy beck

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY (s) WASHINGTON, D.C. 20460 OFFICE OF ADMINISTRATION APR 26 2017 AND RESOURCES MANAGEMENT Nancy Beck Dear Ms. Beek: Congratulations You have been selected for an appointment with the U.S. Environmental Protection Agency (EPA). This is to officially inform you of your position as Deputy Assistant Administrator for Toxics. located in the Office of Chemical Safety and Pollution Prevention: Washington. DC. This position is an Excepted Service Administratively Determined (AD) position. Pursuant to the authority vested in the Administrator under Public Law 95-190, your compensation for this position has been set at $161.900 per annum. Your acceptance of this position means that: (1) your position is not in the competitive service; (2) you will serve at the pleasure of the Administrator: and (3) termination of your appointment may occur at anytime upon notice thereof. During a change in Administration, each position is generally reviewed on a case-by-case basis to determine if they meet the needs of the new Administration's goals and objectives for the Agency. Information About Your Position Your annual salary will be $161,900; Your immediate supervisor will be Wendy Cleland-Hamnett, Acting Assistant Administrator for Chemical Safety and Pollution Prevention; your second level supervisor will be E. Seott Pruitt. Administrator: You will work a full-time schedule: You will be subject to a pre-employment drug test. If your test results are not favorable. your appointment will be terminated: and Your position has been designated by our Personnel Security Office as a High Risk position. This designation will require your position to be subject to random drug testing procedures. The effective date of your appointment is April 30, 2017. We ask that you report for employee orientation on Monday, May 1, 2017 at 8:30 am. You will be met at the William Jefferson Clinton North guard station. When you arrive at the guard station. please call Charles Munoz on 203-564-3097 or Sharnett Willis on 202-564-7866. One of them will meet you at the guard's station in order to sign you into the building. You can reach the Agency by taking the Metro Commuter Rail. Board the Blue or Orange line train and get off at the Federal Triangle Metro Stop. Enter the U.S. Environmental Protection Agency William Jefferson Clinton North Building on your immediate right. internet Adoress (URL) * http://www.epa.gov Printed with Vegelabale oit Based trks on 100% Process Chiorne Free Recycled Paper Source: https://www.industrydocuments.ucsf.edu/docs/npbn0226 What to Bring on Your First Day Monday, May 1. 2017 You should go to the links below to access the forms. Please complete and bring the forms with you on Monday, May Lst. a. Optional Form 306, Declaration for Federal Employment n fill/of0306.pdf b. Standard Form 144, Statement of Prior Federal Service - c. Standard Form 256, Self-Identification of Disability - d. Standard Form 181, Ethnicity and Race Identification N e. Form 2231. FastStart Direct Deposit (need a voided check) - i` Tax form (federal) . Document(s) to establish your identity and employment eligibility (e.g., a current passport. certificate of U.S. citizenship, and/or a current copy of your driver's license) Social Security card issued by the Social Security Administration. Voided check (if you will be moving your direct deposit to another financial institution) If you are unable to produce the required document(s) you must produce a receipt showing that you have applied for the document(s). You will have three days to bring the original document(s) to your local Human Resources Office. Benefits As a non-temporary appointee, you are entitled to the same Federal Benefits package provided to General Schedule employees including: 10 paid Federal Holidays per year 13 days of sick leave each year based on the hours earned each pay period 13 10 26 days of vacation. depending on your years of employment based on the hours earned each pay period National recognized health insurance model that offers choice and flexibility along with substantial employer contributions to premiums. Employee share of premiums can be paid with pre-tax dollars: Source: https://www.industrydocuments.ucsf.edu/docs/npbn0226

what does EPA stands for ?

npbn0226

npbn0226_p0, npbn0226_p1

environmental protection agency, ENVIRONMENTAL PROTECTION AGENCY

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY (s) WASHINGTON, D.C. 20460 OFFICE OF ADMINISTRATION APR 26 2017 AND RESOURCES MANAGEMENT Nancy Beck Dear Ms. Beek: Congratulations You have been selected for an appointment with the U.S. Environmental Protection Agency (EPA). This is to officially inform you of your position as Deputy Assistant Administrator for Toxics. located in the Office of Chemical Safety and Pollution Prevention: Washington. DC. This position is an Excepted Service Administratively Determined (AD) position. Pursuant to the authority vested in the Administrator under Public Law 95-190, your compensation for this position has been set at $161.900 per annum. Your acceptance of this position means that: (1) your position is not in the competitive service; (2) you will serve at the pleasure of the Administrator: and (3) termination of your appointment may occur at anytime upon notice thereof. During a change in Administration, each position is generally reviewed on a case-by-case basis to determine if they meet the needs of the new Administration's goals and objectives for the Agency. Information About Your Position Your annual salary will be $161,900; Your immediate supervisor will be Wendy Cleland-Hamnett, Acting Assistant Administrator for Chemical Safety and Pollution Prevention; your second level supervisor will be E. Seott Pruitt. Administrator: You will work a full-time schedule: You will be subject to a pre-employment drug test. If your test results are not favorable. your appointment will be terminated: and Your position has been designated by our Personnel Security Office as a High Risk position. This designation will require your position to be subject to random drug testing procedures. The effective date of your appointment is April 30, 2017. We ask that you report for employee orientation on Monday, May 1, 2017 at 8:30 am. You will be met at the William Jefferson Clinton North guard station. When you arrive at the guard station. please call Charles Munoz on 203-564-3097 or Sharnett Willis on 202-564-7866. One of them will meet you at the guard's station in order to sign you into the building. You can reach the Agency by taking the Metro Commuter Rail. Board the Blue or Orange line train and get off at the Federal Triangle Metro Stop. Enter the U.S. Environmental Protection Agency William Jefferson Clinton North Building on your immediate right. internet Adoress (URL) * http://www.epa.gov Printed with Vegelabale oit Based trks on 100% Process Chiorne Free Recycled Paper Source: https://www.industrydocuments.ucsf.edu/docs/npbn0226 What to Bring on Your First Day Monday, May 1. 2017 You should go to the links below to access the forms. Please complete and bring the forms with you on Monday, May Lst. a. Optional Form 306, Declaration for Federal Employment n fill/of0306.pdf b. Standard Form 144, Statement of Prior Federal Service - c. Standard Form 256, Self-Identification of Disability - d. Standard Form 181, Ethnicity and Race Identification N e. Form 2231. FastStart Direct Deposit (need a voided check) - i` Tax form (federal) . Document(s) to establish your identity and employment eligibility (e.g., a current passport. certificate of U.S. citizenship, and/or a current copy of your driver's license) Social Security card issued by the Social Security Administration. Voided check (if you will be moving your direct deposit to another financial institution) If you are unable to produce the required document(s) you must produce a receipt showing that you have applied for the document(s). You will have three days to bring the original document(s) to your local Human Resources Office. Benefits As a non-temporary appointee, you are entitled to the same Federal Benefits package provided to General Schedule employees including: 10 paid Federal Holidays per year 13 days of sick leave each year based on the hours earned each pay period 13 10 26 days of vacation. depending on your years of employment based on the hours earned each pay period National recognized health insurance model that offers choice and flexibility along with substantial employer contributions to premiums. Employee share of premiums can be paid with pre-tax dollars: Source: https://www.industrydocuments.ucsf.edu/docs/npbn0226

At what time does the orientation start on Monday, May 1, 2017?

npbn0226

npbn0226_p0, npbn0226_p1

8:30 am.

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY (s) WASHINGTON, D.C. 20460 OFFICE OF ADMINISTRATION APR 26 2017 AND RESOURCES MANAGEMENT Nancy Beck Dear Ms. Beek: Congratulations You have been selected for an appointment with the U.S. Environmental Protection Agency (EPA). This is to officially inform you of your position as Deputy Assistant Administrator for Toxics. located in the Office of Chemical Safety and Pollution Prevention: Washington. DC. This position is an Excepted Service Administratively Determined (AD) position. Pursuant to the authority vested in the Administrator under Public Law 95-190, your compensation for this position has been set at $161.900 per annum. Your acceptance of this position means that: (1) your position is not in the competitive service; (2) you will serve at the pleasure of the Administrator: and (3) termination of your appointment may occur at anytime upon notice thereof. During a change in Administration, each position is generally reviewed on a case-by-case basis to determine if they meet the needs of the new Administration's goals and objectives for the Agency. Information About Your Position Your annual salary will be $161,900; Your immediate supervisor will be Wendy Cleland-Hamnett, Acting Assistant Administrator for Chemical Safety and Pollution Prevention; your second level supervisor will be E. Seott Pruitt. Administrator: You will work a full-time schedule: You will be subject to a pre-employment drug test. If your test results are not favorable. your appointment will be terminated: and Your position has been designated by our Personnel Security Office as a High Risk position. This designation will require your position to be subject to random drug testing procedures. The effective date of your appointment is April 30, 2017. We ask that you report for employee orientation on Monday, May 1, 2017 at 8:30 am. You will be met at the William Jefferson Clinton North guard station. When you arrive at the guard station. please call Charles Munoz on 203-564-3097 or Sharnett Willis on 202-564-7866. One of them will meet you at the guard's station in order to sign you into the building. You can reach the Agency by taking the Metro Commuter Rail. Board the Blue or Orange line train and get off at the Federal Triangle Metro Stop. Enter the U.S. Environmental Protection Agency William Jefferson Clinton North Building on your immediate right. internet Adoress (URL) * http://www.epa.gov Printed with Vegelabale oit Based trks on 100% Process Chiorne Free Recycled Paper Source: https://www.industrydocuments.ucsf.edu/docs/npbn0226 What to Bring on Your First Day Monday, May 1. 2017 You should go to the links below to access the forms. Please complete and bring the forms with you on Monday, May Lst. a. Optional Form 306, Declaration for Federal Employment n fill/of0306.pdf b. Standard Form 144, Statement of Prior Federal Service - c. Standard Form 256, Self-Identification of Disability - d. Standard Form 181, Ethnicity and Race Identification N e. Form 2231. FastStart Direct Deposit (need a voided check) - i` Tax form (federal) . Document(s) to establish your identity and employment eligibility (e.g., a current passport. certificate of U.S. citizenship, and/or a current copy of your driver's license) Social Security card issued by the Social Security Administration. Voided check (if you will be moving your direct deposit to another financial institution) If you are unable to produce the required document(s) you must produce a receipt showing that you have applied for the document(s). You will have three days to bring the original document(s) to your local Human Resources Office. Benefits As a non-temporary appointee, you are entitled to the same Federal Benefits package provided to General Schedule employees including: 10 paid Federal Holidays per year 13 days of sick leave each year based on the hours earned each pay period 13 10 26 days of vacation. depending on your years of employment based on the hours earned each pay period National recognized health insurance model that offers choice and flexibility along with substantial employer contributions to premiums. Employee share of premiums can be paid with pre-tax dollars: Source: https://www.industrydocuments.ucsf.edu/docs/npbn0226

Mention the compensation for beck's AD position has been set per annum

npbn0226

npbn0226_p0, npbn0226_p1

$161,900

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY (s) WASHINGTON, D.C. 20460 OFFICE OF ADMINISTRATION APR 26 2017 AND RESOURCES MANAGEMENT Nancy Beck Dear Ms. Beek: Congratulations You have been selected for an appointment with the U.S. Environmental Protection Agency (EPA). This is to officially inform you of your position as Deputy Assistant Administrator for Toxics. located in the Office of Chemical Safety and Pollution Prevention: Washington. DC. This position is an Excepted Service Administratively Determined (AD) position. Pursuant to the authority vested in the Administrator under Public Law 95-190, your compensation for this position has been set at $161.900 per annum. Your acceptance of this position means that: (1) your position is not in the competitive service; (2) you will serve at the pleasure of the Administrator: and (3) termination of your appointment may occur at anytime upon notice thereof. During a change in Administration, each position is generally reviewed on a case-by-case basis to determine if they meet the needs of the new Administration's goals and objectives for the Agency. Information About Your Position Your annual salary will be $161,900; Your immediate supervisor will be Wendy Cleland-Hamnett, Acting Assistant Administrator for Chemical Safety and Pollution Prevention; your second level supervisor will be E. Seott Pruitt. Administrator: You will work a full-time schedule: You will be subject to a pre-employment drug test. If your test results are not favorable. your appointment will be terminated: and Your position has been designated by our Personnel Security Office as a High Risk position. This designation will require your position to be subject to random drug testing procedures. The effective date of your appointment is April 30, 2017. We ask that you report for employee orientation on Monday, May 1, 2017 at 8:30 am. You will be met at the William Jefferson Clinton North guard station. When you arrive at the guard station. please call Charles Munoz on 203-564-3097 or Sharnett Willis on 202-564-7866. One of them will meet you at the guard's station in order to sign you into the building. You can reach the Agency by taking the Metro Commuter Rail. Board the Blue or Orange line train and get off at the Federal Triangle Metro Stop. Enter the U.S. Environmental Protection Agency William Jefferson Clinton North Building on your immediate right. internet Adoress (URL) * http://www.epa.gov Printed with Vegelabale oit Based trks on 100% Process Chiorne Free Recycled Paper Source: https://www.industrydocuments.ucsf.edu/docs/npbn0226 What to Bring on Your First Day Monday, May 1. 2017 You should go to the links below to access the forms. Please complete and bring the forms with you on Monday, May Lst. a. Optional Form 306, Declaration for Federal Employment n fill/of0306.pdf b. Standard Form 144, Statement of Prior Federal Service - c. Standard Form 256, Self-Identification of Disability - d. Standard Form 181, Ethnicity and Race Identification N e. Form 2231. FastStart Direct Deposit (need a voided check) - i` Tax form (federal) . Document(s) to establish your identity and employment eligibility (e.g., a current passport. certificate of U.S. citizenship, and/or a current copy of your driver's license) Social Security card issued by the Social Security Administration. Voided check (if you will be moving your direct deposit to another financial institution) If you are unable to produce the required document(s) you must produce a receipt showing that you have applied for the document(s). You will have three days to bring the original document(s) to your local Human Resources Office. Benefits As a non-temporary appointee, you are entitled to the same Federal Benefits package provided to General Schedule employees including: 10 paid Federal Holidays per year 13 days of sick leave each year based on the hours earned each pay period 13 10 26 days of vacation. depending on your years of employment based on the hours earned each pay period National recognized health insurance model that offers choice and flexibility along with substantial employer contributions to premiums. Employee share of premiums can be paid with pre-tax dollars: Source: https://www.industrydocuments.ucsf.edu/docs/npbn0226

what is the effective date of beck's appointment?

npbn0226

npbn0226_p0, npbn0226_p1

April 30,2017., april 30, 2017

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY (s) WASHINGTON, D.C. 20460 OFFICE OF ADMINISTRATION APR 26 2017 AND RESOURCES MANAGEMENT Nancy Beck Dear Ms. Beek: Congratulations You have been selected for an appointment with the U.S. Environmental Protection Agency (EPA). This is to officially inform you of your position as Deputy Assistant Administrator for Toxics. located in the Office of Chemical Safety and Pollution Prevention: Washington. DC. This position is an Excepted Service Administratively Determined (AD) position. Pursuant to the authority vested in the Administrator under Public Law 95-190, your compensation for this position has been set at $161.900 per annum. Your acceptance of this position means that: (1) your position is not in the competitive service; (2) you will serve at the pleasure of the Administrator: and (3) termination of your appointment may occur at anytime upon notice thereof. During a change in Administration, each position is generally reviewed on a case-by-case basis to determine if they meet the needs of the new Administration's goals and objectives for the Agency. Information About Your Position Your annual salary will be $161,900; Your immediate supervisor will be Wendy Cleland-Hamnett, Acting Assistant Administrator for Chemical Safety and Pollution Prevention; your second level supervisor will be E. Seott Pruitt. Administrator: You will work a full-time schedule: You will be subject to a pre-employment drug test. If your test results are not favorable. your appointment will be terminated: and Your position has been designated by our Personnel Security Office as a High Risk position. This designation will require your position to be subject to random drug testing procedures. The effective date of your appointment is April 30, 2017. We ask that you report for employee orientation on Monday, May 1, 2017 at 8:30 am. You will be met at the William Jefferson Clinton North guard station. When you arrive at the guard station. please call Charles Munoz on 203-564-3097 or Sharnett Willis on 202-564-7866. One of them will meet you at the guard's station in order to sign you into the building. You can reach the Agency by taking the Metro Commuter Rail. Board the Blue or Orange line train and get off at the Federal Triangle Metro Stop. Enter the U.S. Environmental Protection Agency William Jefferson Clinton North Building on your immediate right. internet Adoress (URL) * http://www.epa.gov Printed with Vegelabale oit Based trks on 100% Process Chiorne Free Recycled Paper Source: https://www.industrydocuments.ucsf.edu/docs/npbn0226 What to Bring on Your First Day Monday, May 1. 2017 You should go to the links below to access the forms. Please complete and bring the forms with you on Monday, May Lst. a. Optional Form 306, Declaration for Federal Employment n fill/of0306.pdf b. Standard Form 144, Statement of Prior Federal Service - c. Standard Form 256, Self-Identification of Disability - d. Standard Form 181, Ethnicity and Race Identification N e. Form 2231. FastStart Direct Deposit (need a voided check) - i` Tax form (federal) . Document(s) to establish your identity and employment eligibility (e.g., a current passport. certificate of U.S. citizenship, and/or a current copy of your driver's license) Social Security card issued by the Social Security Administration. Voided check (if you will be moving your direct deposit to another financial institution) If you are unable to produce the required document(s) you must produce a receipt showing that you have applied for the document(s). You will have three days to bring the original document(s) to your local Human Resources Office. Benefits As a non-temporary appointee, you are entitled to the same Federal Benefits package provided to General Schedule employees including: 10 paid Federal Holidays per year 13 days of sick leave each year based on the hours earned each pay period 13 10 26 days of vacation. depending on your years of employment based on the hours earned each pay period National recognized health insurance model that offers choice and flexibility along with substantial employer contributions to premiums. Employee share of premiums can be paid with pre-tax dollars: Source: https://www.industrydocuments.ucsf.edu/docs/npbn0226

What does the Figure 1 show?

ylcn0226

ylcn0226_p0, ylcn0226_p1, ylcn0226_p2, ylcn0226_p3, ylcn0226_p4, ylcn0226_p5, ylcn0226_p6, ylcn0226_p7, ylcn0226_p8, ylcn0226_p9

A Two-step Process for Conducting Risk Evaluations, A Two-Step Process for Conducting Risk Evaluations

Search 1/19/17 snapshot Assessing and Managing Chemicals under TSCA Contact Us Share Assessing and Managing Chemicals under The Frank R. Lautenberg TSCA Home Chemical Safety for the How EPA Assesses Chemical Safety 2 1st Century Act Assessments for TSCA Work Plan Chemicals On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for Sign up for Current Chemical the 21st Century Act which amends the Toxic TSCA and Risk Reduction Activities Other Substances Control Act (ISCA), the Nation's Chemical ChemView primary chemicals management law. Safety News Chemical Data Reporting The new law, which received bipartisan support in both the U.S. House of Representatives and Getemail alerts the Senate, includes much needed improvements such as: Enter email address sign up Mandatory requirement for EPA to evaluate existing chemicals with clear and enforceable deadlines; New risk-based safety standard; Increased public transparency for chemical information; and Recent Consistent source of funding for EPA to carry additions out the responsibilities under the new law. Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 American" Chemistry Council August 24, 2016 Wendy Cleland-Hamnett Director, Office of Pollution Prevention and Toxics Environmental Protection Agency 1200 Pennsylvania Ave. NW Washington, DC 20460-0001 Sent electronically to www.regulations.gov docket # EPA-HQ-OPPT-2016-0400 Re: ACC Comments to Inform EPA's Rulemaking on the Conduct of Risk Evaluations under the Lautenberg Chemical Safety Act Dear Ms. Cleland-Hamnett: The American Chemistry Council (ACC¹ appreciates the opportunity to provide input to the Office of Pollution Prevention and Toxics to inform the Agency's development of a risk evaluation rulemaking under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (LCSA). ACC has a long-standing commitment to a robust, science-based approach to evaluation of human and environmental risk. ACC is committed to the effective implementation of the LCSA and supports a workable, rigorous process that allows for timely, high quality reviews. Given the strong emphasis on a risk-based approach in the LCSA, the Section 6(b)(4) rulemaking is particularly important because it will guide the conduct of future risk evaluations that will then inform risk management activities. ACC is committed to being a constructive stakeholder throughout the implementation of LCSA. We will continue to draw from the breadth and depth of our member companies' expertise to ensure that our recommendations are not only science-based, but also allow for the efficient and effective implementation of the LCSA. In doing so, ACC will continue to consider the high quality science standards in the LCSA as well as the timeframes and deadlines imposed therein. The enclosed recommendations were developed with these important considerations in mind. If EPA has any questions, please contact me at nancy [email protected] or 202-249-6417. Sincerely, Nancy B. Beck, PhD, DABT Senior Director, Regulatory and Technical Affairs Cc: Jim Jones, OCSPP Assistant Administrator Louise Wise, Deputy Assistant Administrator Jeffery Morris, Deputy Director for Programs, OPPT Tala Henry, Director, Risk Assessment Division, OPPT 1 The American Chemistry Council (ACC) represents the leading companies engaged in the business of chemistry. More information about ACC is presented in the body of our comments. 1 IPage Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 American Chemistry Council Initial Input to U.S. Environmental Protection Agency In Regard to the Risk Evaluation Rule under the Lautenberg Chemical Safety Act Table of Contents I. Introduction and Executive Summary 4 II. The Risk Evaluation Rulemaking Must Include both Procedural And Substantive Elements to Effect the Purposes of the Statute 5 III. The Proposed Rule Should Include a Tiered Approach to Risk Evaluation 6 IV. The Rule Should Clarify the Process for Preparation and Contents of the Scope 8 V. The Proposed Rule Should Include a Detailed Description of Substantive Elements of Risk Evaluation 8 VI. Proposed Rule Should Ensure Consistency with Section 6(b)(4)(F) 9 a. Integration and Assessment of Information Relevant to Risks and Information on Potentially Exposed and Susceptible Populations 10 i. Conditions of Use That are Relevant 10 ii. Potentially Exposed or Susceptible Subpopulations 10 b. Aggregate and Sentinel Exposures 12 i. Aggregate Exposures 12 ii. Sentinel Exposures 12 c. Exposure Assessment 13 d. Weight of the Evidence 14 VII. The Proposed Rule Should Incorporate Section 26(h) Scientific Standards 14 a. Fit-for-Purpose Approach 15 b. Consideration of Relevant Information 16 i. Improving Hazard Assessment 16 ii. Improving Dose Response Assessment 17 iii. Reliance on Guidance 17 c. Importance of High Quality Risk Characterization 18 d. Clearly Addressing Variability and Uncertainty 18 e. Ensuring Appropriate Peer Review and Forming a Science Advisory Committee on Chemicals 19 21 Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 VIII. The Proposed Rule Should Implement a Weight of the Scientific Evidence (WoE) Approach 20 a. Systematic Review is Required 20 i. Development of a Protocol 21 ii. Search Strategy 21 iii. Transparency 21 b. A Systematic Review is Not Automatically a WoE Assessment 21 c. WoE and Systematic Review for Screening Level Risk Evaluations 22 d. WoE and Systematic Review for Refined Risk Evaluations 22 e. Strength of Evidence is Not the Same as WoE 23 IX. EPA Should Make Information Available Consistent with Section 26(j) 24 X. EPA Should Use Reasonably Available Information and CBI Consistent with Section 26(k) 24 XI. EPA Should Utilize Fit-for-Purpose Exposure Evaluation Tools 25 XII. The Requirements of Sections 6 and 26 Apply to Environmental Risk Evaluations 26 a. Advancing Models for Environmental Risks 27 b. Improving Data Sourcing, Generation, and Evaluation 27 c. Persistent, Bioaccumulative and Toxic (PBT) Substances 28 XIII. EPA Should Leverage International and Inter-Agency Cooperation 28 XIV. Incorporating High Throughput Tools and Alternative Methods 29 XV. Stakeholders and EPA Must Be Held to the Same High Standard 30 APPENDIX A: ACC's Principles for Improving Chemical Hazard and Risk Assessment 31 APPENDIX B: Improving Hazard Assessment 32 APPENDIX C: Improving Does Response Assessment 33 APPRNDIX D: Improving Risk Characterization 35 APPENDIX E: Ensuring Robust Peer Review 37 APPENDIX F: Exposure Modeling Tools 39 APPENDIX G: Additional Information on the ECETOC TRA 41 3 I P a 3 e Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 I. Introduction and Executive Summary The American Chemistry Council (ACC)2 is pleased to provide the U.S. Environmental Protection Agency (EPA) this initial input on the Lautenberg Chemical Safety Act's (LCSA) requirement for the Agency to establish, by rule, the process for conducting risk evaluations. ACC appreciates EPA's early efforts to obtain input from stakeholders at its August 9, 2016, public meeting. We also appreciate EPA's solicitation of written comments to be entered into the docket, well in advance of publication of the proposed rule. Our comments both clarify, as well as supplement and expand upon, the oral comments we presented at the August 9 meeting. ACC strongly supported Congress' efforts to update and reform the Toxic Substances Control Act (TSCA). We believe that high quality risk evaluation, using best available science and weight of the evidence (WoE), is at the very heart of the LCSA. Effective and efficient risk evaluations will help deliver the results intended by Congress. Section 6(b)(4)(B) of the statute requires EPA to establish, by rule, "a process to conduct risk evaluations.' This certainly should include a description of the sequence of events, timelines, opportunities for public comments and peer review. Both Sections 6 and 26 of the LCSA outline various substantive elements that apply to and inform risk evaluation. A risk evaluation must: Be conducted in a manner designed to determine "whether a chemical substance presents an unreasonable risk of injury to health or the environment;" as set out in Section 6(b)(4)(A); Identify whether there exists "an unreasonable risk to a potentially exposed or susceptible subpopulation." EPA must identify potentially exposed or susceptible subpopulations relevant to the risk evaluation under conditions of use; Address the specific elements set out in Section 6(b)(4)(F); and Comply with the specific requirements of Section 26, including the best available science, weight of the evidence, and transparency requirements. Because these elements are at the core of the risk evaluation process, and affect risk management measures, they are substantive and should be described in adequate detail in the regulation. In general, where risk evaluation elements are now required by statute, EPA should apply them uniformly and universally reflecting them in the body of the regulation. The recommendations provided by ACC in these comments address screening and refined risk evaluations and are meant to apply to both human health and environmental risks. Specific tools, testing methods, databases, and the like may develop over time, or course, and can be updated as necessary in policies, 2 The American Chemistry Council (ACC) represents the leading companies engaged in the business of chemistry. ACC members apply the science of chemistry to make innovative products and services that make people's lives better, healthier and safer. ACC is committed to improved environmental, health and safety performance through Responsible Care common sense advocacy designed to address major public policy issues, and health and environmental research and product testing. The business of chemistry is a $797 billion enterprise and a key element of the nation's economy. It is the nation's largest exporter, accounting for fourteen percent of all U.S. exports. Chemistry companies are among the largest investors in research and development. Safety and security have always been primary concerns of ACC members, and they have intensified their efforts, working closely with government agencies to improve security and to defend against any threat to the nation's critical infrastructure. 4 Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 procedures and guidance. Our comments strive to make these differentiations and explain where particular elements of risk evaluation should be included in the rule proper. Specifically, our recommendations suggest definitions, and procedural steps and elements that will allow EPA to ensure that risk evaluations are consistent with the statutory requirements for EPA to use the best available science and WoE approaches. The recommendations also include definitions and procedural steps are not expected to change over time. ACC has referenced each of our suggestions to an existing EPA guidance, a National Academies (NAS) report, or another authoritative body or peer reviewed report. For instance, the recommendations in EPA's 2000 Risk Characterization Handbook still represent best practices today. Adding adequate definitions and explanation to the rule is particularly important to achieving incorporation of statutory requirements. We also note that in addition to Section 6, Sections 26(h), 26(i), 26(j), and 26(k) of the LCSA each present legal requirements that are applicable to the risk evaluation. EPA will now need to provide a level of transparency regarding not only the inputs, but also the methods of the analysis, including clear descriptions of uncertainties and variability. EPA should leverage information from other jurisdictions where data and information is applicable and of sufficient quality to meet the science standards in the LCSA. Incorporating these elements into the rulemaking creates a better platform for clear and consistent articulation of the Agency's understanding of statutory requirements, and will better support consistent and uniform application of the elements of risk evaluation. It is critically important that EPA engage the public as EPA plans, scopes, and conducts risk evaluations. Industry scientists often have unique insight and experience with their companies' chemistries and collectively have a large body of knowledge of risk assessment processes globally, including an understanding of potential human health and environmental impacts. ACC encourages EPA to leverage this knowledge and engage early (well before draft risk evaluations are released) and frequently with industry throughout the risk evaluation process. II. The Risk Evaluation Rulemaking Must Include both Procedural and Substantive Elements to Effect the Purposes of the Statute Congress included a specific mandate to EPA to establish a risk evaluation rulemaking. There is little question that the rule must describe the process by which risk evaluations will be conducted. However, to 3 effect the purposes of the statute, the process described in the rule cannot merely set out timelines or the sequence of the risk evaluation. It must include a clear articulation of the substantive elements of risk evaluation, and more particularly, it must explain how it will apply the principles set out in Section 6(b)(4)(F), Section 26, and other parts of the statute. If Congress had intended the scientific standard of "best available science" or "weight of the scientific evidence" to be incorporated into guidance alone, it would have included them only in Section 26(1) on "policies, procedures and guidance." 3 "[T]he Administrator shall establish, by rule, a process to conduct risk evaluations in accordance with subparagraph (A) " Section 6(b)(4)(A). 5 I Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 The very purpose of the risk evaluation is to develop the evidentiary and scientific basis to enable EPA to complete the risk determination required by statute. That risk determination has substantive impact - it significantly affects conduct, activity or a substantive interest that is the subject of agency regulation. The determination following risk evaluation is a necessary prerequisite for a chemical to proceed to risk management, if warranted. The rule should thus include a clear description of how EPA will undertake risk evaluations in order to meet the new statutory requirements of the LCSA. This includes a description of the scoping process and requirements for a published scope as well as the elements of the risk evaluation itself and the mechanism for gauging adequacy as measured against statutory criteria. III. The Proposed Rule Should Include a Tiered Approach to Risk Evaluation We believe the statute contemplates a tiered approach to risk evaluation and recommend that EPA include a tiered approach in the rule. Under the LCSA, EPA must initiate the risk evaluation "upon designating" a chemical as a high-priority substance. The scope, however, is not required to be published "upon initiation" -- EPA has up to six months following the initiation of the risk evaluation to prepare and publish the scope. Congress intended this six month period to be used for a scoping exercise, where EPA identifies "the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations the Administrator expects to consider in the risk evaluation." This six month period is a "step" between the high priority designation and the publication of the scope. In order for EPA to conduct risk evaluations consistent with the quality required by the LCSA and within the timeframes required, EPA should conduct a screening level evaluation during the scoping phase. During the scoping phase of risk evaluations, tools exist to allow EPA to conduct quantitative screening level analyses of multiple exposure scenarios, as appropriate for consumers, sensitive subpopulations, and the environment. This will allow EPA to have a more tailored focus on those populations and exposures of greatest concern during a refined risk evaluation process. Figure 1 below depicts ACC's recommended approach. 6 I Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 - y 10 Worknlan High-Duality Refined Risk Evaluation High Pricrity Chemicats & DRAFT Chemicals Manufacturer Risk Evaluation Requested EXPOSSURES HAZARD Evaluation incorporating Sections 6 and 26 of the Lautenberg Chemicel Safety Act (LCSA): Scope/Screening Level Risk Evatuation Scientific Standards FINAL Susceprible Weight of Scientific Evidence Evaluations Risk Evaluation Exposures Pupulations or use Certain Conditions of Use Present Do not present an anreasonable risk an unreasonable risk Refined No further risk evaluation risk avaluation No further action; needed RUREMAKING PROCESS COMPLETE the Figure 1. A Two-Step Process for Conducting Risk Evaluations Note: This is a simplified version of the process. A tiered approach, where EPA uses the scoping step (step 1) to conduct a quantitative screening level analysis, will allow EPA to focus its limited resources on more robust refined risk evaluations for only those conditions of use where unreasonable risks cannot be ruled out. Screening-level assessments require less data and information, and are typically deterministic and based on conservative, health protective assumptions and methods. When a screening assessment indicates low risk for a particular condition of use, the Agency should have a high degree of confidence that the potential risks are much lower than the calculation and, therefore, the actual risks are lower and/or perhaps non-existent. However, when a screening-level risk assessment indicates a potential concern for an adverse effect, this does not mean that the actual risks are significant and warrant action. Rather, it indicates the Agency should take a second step in the risk evaluation process to refine the evaluation to more accurately quantify potential risks. The refined risk evaluation (step 2) will require realistic and representative data, higher tier modeling approaches, including probabilistic exposure modeling, and a more comprehensive consideration of human relevance and dose-response relationships. In a refined evaluation, EPA should also consider targeted exposure studies, as well as biomonitoring and environmental monitoring data, to the extent that this information is available and relevant. This approach is consistent with EPA's 2014 Framework for Human Health Risk Assessment to Inform Decision Making (HHRA Framework)4. which also emphasizes the importance of a fit-for-purpose approach to risk evaluation. This approach is also consistent with EPA's exposure assessment guidelines and practices. The concept of a tiered approach and a fit-for-purpose 5 evaluation are woven throughout ACC's recommendations. 4 See tps://www.epa.gov/sites/production/files/2014-12/documents/hhra-framework-final-2014.pdf. 5 See: tps://www.epa.gov/expobox/exposure-assessment-tools-tiers-and-types-screening-level-and-refined. 7 Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 The tiered approach ACC recommends is consistent with the approach EPA took in the problem formulation and initial assessment document for tetrabromobisphenol A (TBBPA.6 In that document, EPA conducted an initial screening level evaluation to support its conceptual model and analysis plan. EPA appropriately used high-end exposure values coupled with the lowest toxicity values to evaluate uses and exposure pathways of potential concern. While EPA did not share the relevant risk evaluation calculations in its public document, the general approach is consistent with that of a screening level risk evaluation. ACC encourages EPA to continue with this approach and to transparently and clearly present quantitative screening level analyses for the conditions of use and exposure scenarios that are part of the conceptual model EPA develops as part of the scoping phase. IV. The Rule Should Clarify the Process for Preparation and Contents of the Scope As noted above, Congress allowed a six month period for preparation of the scope of the risk evaluation, contemplating that time and effort would be needed to move from prioritization to a published scope. The six month period is to enable EPA to identify "the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations the Administrator expects to consider in the risk evaluation." Two things are evident from this language and the time frame afforded: 1) EPA should use this period to evaluate and decide which, if any, potentially exposed or susceptible subpopulations should be included in the risk evaluation (in other words, it need not include all such subpopulations, regardless of size, impact, or relevance); and 2) tEPA has flexibility to actually conduct a full risk evaluation of some or all the potential scenarios set out in the scope. In short, EPA need not include every conceivable condition of use in a risk evaluation. This view is further buttressed by the definition of "conditions of use" in Section 3 of the LCSA, which points to the need for EPA to determine the relevant conditions of use: "the circumstances, as determined by the Administrator, under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of." (Emphasis added). V. The Proposed Rule Should Include a Detailed Description of Substantive Elements of Risk Evaluation The term, "risk evaluation" is not expressly defined in the LCSA. While the term "risk assessment" has been widely used in EPA programs and operationally has clear meaning derived from years of guidance, policies and practices, that term was not used in the statute. Therefore even though it may be reasonable to assume "risk evaluation" may fully equate with the term "risk assessment," given the context of its use (integrating hazard with exposure) in the LCSA, EPA is encouraged to explicitly define and operationalize this term as part of its rulemaking. The term will not have clear meaning until an interpretation is assigned by EPA. We believe the essential elements of a Section 6 and 26 risk evaluation must be articulated in a clear regulatory definition as we discuss below. 6 EPA, Problem Formulation and Initial Assessment Tetrabromobisphenol A and Related Chemicals Cluster Flame Retardants, 2015, available at: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/tsca-work-plan-chemical-problem- formulation-and-2. 8 IPage Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 Section 6(b)(4)(B) of the statute requires EPA to establish, by rule, "a process to conduct risk evaluations." This process is itself required to meet a number of substantive elements described in the LCSA; a risk evaluation must: Be conducted in a manner designed to help the agency determine "whether a chemical substance presents an unreasonable risk of injury to health or the environment;" as set out in Section 6(b)(4)(A). Include consideration of "an unreasonable risk to a potentially exposed or susceptible subpopulation." EPA must identify relevant potentially exposed or susceptible subpopulations relevant to the risk evaluation under conditions of use; Address the specific elements set out in Section 6(b)(4)(F); and Comply with the specific requirements of Section 26, including the best available science, weight of the evidence, and transparency requirements. The very purpose of the risk evaluation is to develop the evidentiary and scientific basis to enable EPA to complete the risk determination required by statute. That risk determination has substantive impact - it significantly affects conduct, activity or a substantive interest that is the subject of agency regulation. The basis for the risk determination thus should be adequately described in the rule itself to offer sufficient notice to the regulated community. This is particularly important for decisions that inform safety and safety determinations. Likewise, decisions that have broad reaching impact should be supported in regulations, not merely through guidance or agency policy. 8 While EPA cannot substitute policy or guidance for a regulatory description of what will constitute a complete and robust risk evaluation, we believe the necessary elements can be developed in this rulemaking in a timely manner. VI. The Proposed Rule Should Ensure Consistency with Section 6(b)(4)(F) As discussed below, Section 6(b)(4)(F) of the LCSA describes five requirements for risk evaluations that shall be considered by the Administrator and must be incorporated into the risk evaluation rulemaking. 7 See, e.g., MST Express v. U.S. Department of Transportation, 108 F.3d 401 (D.C. Cir. 1997). DOT was directed under the Motor Carrier Safety Act (MCSA) to "prescribe regulations establishing a procedure to decide on the safety fitness of owners and operators of commercial motor vehicles." [Emphasis added]. The MCSA stated that implementing regulations would include "a means of deciding whether the owners, operators, and persons meet the safety fitness requirements." DOT promulgated regulations that set out a process for decision making but used guidance to articulate the tests by which the agency would determine whether vehicles met the safety fitness requirements. The court rejected DOT's reliance on guidance because it "failed to carry out its statutory obligation to establish by regulation a means of determining whether a carrier has complied with the safety fitness requirements." 8 As a general matter, "...it seems to be established that "regulations,' 'substantive rules' or 'legislative rules' are those which create law, usually implementary to an existing law." Gibson Wine Co. v. Snyder, 194 F.2d 329, 331 (D.C. Cir. 1952), cited by Brown Express, Inc. v. U.S., 607 F.2d 695, 700 (5th Cir. 1979). A "rule" is defined under Section 2 of the Administrative Procedure Act, in relevant part, as: "the whole or part of an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy or describing the organization, procedure, or practice requirements of an agency." 5 U.S.C. § 551(4). 9 I Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226

What is the next step in the diagram after Present an unreasonable risk?

ylcn0226

ylcn0226_p0, ylcn0226_p1, ylcn0226_p2, ylcn0226_p3, ylcn0226_p4, ylcn0226_p5, ylcn0226_p6, ylcn0226_p7, ylcn0226_p8, ylcn0226_p9

Rulemaking, RULEMAKING

Search 1/19/17 snapshot Assessing and Managing Chemicals under TSCA Contact Us Share Assessing and Managing Chemicals under The Frank R. Lautenberg TSCA Home Chemical Safety for the How EPA Assesses Chemical Safety 2 1st Century Act Assessments for TSCA Work Plan Chemicals On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for Sign up for Current Chemical the 21st Century Act which amends the Toxic TSCA and Risk Reduction Activities Other Substances Control Act (ISCA), the Nation's Chemical ChemView primary chemicals management law. Safety News Chemical Data Reporting The new law, which received bipartisan support in both the U.S. House of Representatives and Getemail alerts the Senate, includes much needed improvements such as: Enter email address sign up Mandatory requirement for EPA to evaluate existing chemicals with clear and enforceable deadlines; New risk-based safety standard; Increased public transparency for chemical information; and Recent Consistent source of funding for EPA to carry additions out the responsibilities under the new law. Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 American" Chemistry Council August 24, 2016 Wendy Cleland-Hamnett Director, Office of Pollution Prevention and Toxics Environmental Protection Agency 1200 Pennsylvania Ave. NW Washington, DC 20460-0001 Sent electronically to www.regulations.gov docket # EPA-HQ-OPPT-2016-0400 Re: ACC Comments to Inform EPA's Rulemaking on the Conduct of Risk Evaluations under the Lautenberg Chemical Safety Act Dear Ms. Cleland-Hamnett: The American Chemistry Council (ACC¹ appreciates the opportunity to provide input to the Office of Pollution Prevention and Toxics to inform the Agency's development of a risk evaluation rulemaking under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (LCSA). ACC has a long-standing commitment to a robust, science-based approach to evaluation of human and environmental risk. ACC is committed to the effective implementation of the LCSA and supports a workable, rigorous process that allows for timely, high quality reviews. Given the strong emphasis on a risk-based approach in the LCSA, the Section 6(b)(4) rulemaking is particularly important because it will guide the conduct of future risk evaluations that will then inform risk management activities. ACC is committed to being a constructive stakeholder throughout the implementation of LCSA. We will continue to draw from the breadth and depth of our member companies' expertise to ensure that our recommendations are not only science-based, but also allow for the efficient and effective implementation of the LCSA. In doing so, ACC will continue to consider the high quality science standards in the LCSA as well as the timeframes and deadlines imposed therein. The enclosed recommendations were developed with these important considerations in mind. If EPA has any questions, please contact me at nancy [email protected] or 202-249-6417. Sincerely, Nancy B. Beck, PhD, DABT Senior Director, Regulatory and Technical Affairs Cc: Jim Jones, OCSPP Assistant Administrator Louise Wise, Deputy Assistant Administrator Jeffery Morris, Deputy Director for Programs, OPPT Tala Henry, Director, Risk Assessment Division, OPPT 1 The American Chemistry Council (ACC) represents the leading companies engaged in the business of chemistry. More information about ACC is presented in the body of our comments. 1 IPage Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 American Chemistry Council Initial Input to U.S. Environmental Protection Agency In Regard to the Risk Evaluation Rule under the Lautenberg Chemical Safety Act Table of Contents I. Introduction and Executive Summary 4 II. The Risk Evaluation Rulemaking Must Include both Procedural And Substantive Elements to Effect the Purposes of the Statute 5 III. The Proposed Rule Should Include a Tiered Approach to Risk Evaluation 6 IV. The Rule Should Clarify the Process for Preparation and Contents of the Scope 8 V. The Proposed Rule Should Include a Detailed Description of Substantive Elements of Risk Evaluation 8 VI. Proposed Rule Should Ensure Consistency with Section 6(b)(4)(F) 9 a. Integration and Assessment of Information Relevant to Risks and Information on Potentially Exposed and Susceptible Populations 10 i. Conditions of Use That are Relevant 10 ii. Potentially Exposed or Susceptible Subpopulations 10 b. Aggregate and Sentinel Exposures 12 i. Aggregate Exposures 12 ii. Sentinel Exposures 12 c. Exposure Assessment 13 d. Weight of the Evidence 14 VII. The Proposed Rule Should Incorporate Section 26(h) Scientific Standards 14 a. Fit-for-Purpose Approach 15 b. Consideration of Relevant Information 16 i. Improving Hazard Assessment 16 ii. Improving Dose Response Assessment 17 iii. Reliance on Guidance 17 c. Importance of High Quality Risk Characterization 18 d. Clearly Addressing Variability and Uncertainty 18 e. Ensuring Appropriate Peer Review and Forming a Science Advisory Committee on Chemicals 19 21 Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 VIII. The Proposed Rule Should Implement a Weight of the Scientific Evidence (WoE) Approach 20 a. Systematic Review is Required 20 i. Development of a Protocol 21 ii. Search Strategy 21 iii. Transparency 21 b. A Systematic Review is Not Automatically a WoE Assessment 21 c. WoE and Systematic Review for Screening Level Risk Evaluations 22 d. WoE and Systematic Review for Refined Risk Evaluations 22 e. Strength of Evidence is Not the Same as WoE 23 IX. EPA Should Make Information Available Consistent with Section 26(j) 24 X. EPA Should Use Reasonably Available Information and CBI Consistent with Section 26(k) 24 XI. EPA Should Utilize Fit-for-Purpose Exposure Evaluation Tools 25 XII. The Requirements of Sections 6 and 26 Apply to Environmental Risk Evaluations 26 a. Advancing Models for Environmental Risks 27 b. Improving Data Sourcing, Generation, and Evaluation 27 c. Persistent, Bioaccumulative and Toxic (PBT) Substances 28 XIII. EPA Should Leverage International and Inter-Agency Cooperation 28 XIV. Incorporating High Throughput Tools and Alternative Methods 29 XV. Stakeholders and EPA Must Be Held to the Same High Standard 30 APPENDIX A: ACC's Principles for Improving Chemical Hazard and Risk Assessment 31 APPENDIX B: Improving Hazard Assessment 32 APPENDIX C: Improving Does Response Assessment 33 APPRNDIX D: Improving Risk Characterization 35 APPENDIX E: Ensuring Robust Peer Review 37 APPENDIX F: Exposure Modeling Tools 39 APPENDIX G: Additional Information on the ECETOC TRA 41 3 I P a 3 e Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 I. Introduction and Executive Summary The American Chemistry Council (ACC)2 is pleased to provide the U.S. Environmental Protection Agency (EPA) this initial input on the Lautenberg Chemical Safety Act's (LCSA) requirement for the Agency to establish, by rule, the process for conducting risk evaluations. ACC appreciates EPA's early efforts to obtain input from stakeholders at its August 9, 2016, public meeting. We also appreciate EPA's solicitation of written comments to be entered into the docket, well in advance of publication of the proposed rule. Our comments both clarify, as well as supplement and expand upon, the oral comments we presented at the August 9 meeting. ACC strongly supported Congress' efforts to update and reform the Toxic Substances Control Act (TSCA). We believe that high quality risk evaluation, using best available science and weight of the evidence (WoE), is at the very heart of the LCSA. Effective and efficient risk evaluations will help deliver the results intended by Congress. Section 6(b)(4)(B) of the statute requires EPA to establish, by rule, "a process to conduct risk evaluations.' This certainly should include a description of the sequence of events, timelines, opportunities for public comments and peer review. Both Sections 6 and 26 of the LCSA outline various substantive elements that apply to and inform risk evaluation. A risk evaluation must: Be conducted in a manner designed to determine "whether a chemical substance presents an unreasonable risk of injury to health or the environment;" as set out in Section 6(b)(4)(A); Identify whether there exists "an unreasonable risk to a potentially exposed or susceptible subpopulation." EPA must identify potentially exposed or susceptible subpopulations relevant to the risk evaluation under conditions of use; Address the specific elements set out in Section 6(b)(4)(F); and Comply with the specific requirements of Section 26, including the best available science, weight of the evidence, and transparency requirements. Because these elements are at the core of the risk evaluation process, and affect risk management measures, they are substantive and should be described in adequate detail in the regulation. In general, where risk evaluation elements are now required by statute, EPA should apply them uniformly and universally reflecting them in the body of the regulation. The recommendations provided by ACC in these comments address screening and refined risk evaluations and are meant to apply to both human health and environmental risks. Specific tools, testing methods, databases, and the like may develop over time, or course, and can be updated as necessary in policies, 2 The American Chemistry Council (ACC) represents the leading companies engaged in the business of chemistry. ACC members apply the science of chemistry to make innovative products and services that make people's lives better, healthier and safer. ACC is committed to improved environmental, health and safety performance through Responsible Care common sense advocacy designed to address major public policy issues, and health and environmental research and product testing. The business of chemistry is a $797 billion enterprise and a key element of the nation's economy. It is the nation's largest exporter, accounting for fourteen percent of all U.S. exports. Chemistry companies are among the largest investors in research and development. Safety and security have always been primary concerns of ACC members, and they have intensified their efforts, working closely with government agencies to improve security and to defend against any threat to the nation's critical infrastructure. 4 Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 procedures and guidance. Our comments strive to make these differentiations and explain where particular elements of risk evaluation should be included in the rule proper. Specifically, our recommendations suggest definitions, and procedural steps and elements that will allow EPA to ensure that risk evaluations are consistent with the statutory requirements for EPA to use the best available science and WoE approaches. The recommendations also include definitions and procedural steps are not expected to change over time. ACC has referenced each of our suggestions to an existing EPA guidance, a National Academies (NAS) report, or another authoritative body or peer reviewed report. For instance, the recommendations in EPA's 2000 Risk Characterization Handbook still represent best practices today. Adding adequate definitions and explanation to the rule is particularly important to achieving incorporation of statutory requirements. We also note that in addition to Section 6, Sections 26(h), 26(i), 26(j), and 26(k) of the LCSA each present legal requirements that are applicable to the risk evaluation. EPA will now need to provide a level of transparency regarding not only the inputs, but also the methods of the analysis, including clear descriptions of uncertainties and variability. EPA should leverage information from other jurisdictions where data and information is applicable and of sufficient quality to meet the science standards in the LCSA. Incorporating these elements into the rulemaking creates a better platform for clear and consistent articulation of the Agency's understanding of statutory requirements, and will better support consistent and uniform application of the elements of risk evaluation. It is critically important that EPA engage the public as EPA plans, scopes, and conducts risk evaluations. Industry scientists often have unique insight and experience with their companies' chemistries and collectively have a large body of knowledge of risk assessment processes globally, including an understanding of potential human health and environmental impacts. ACC encourages EPA to leverage this knowledge and engage early (well before draft risk evaluations are released) and frequently with industry throughout the risk evaluation process. II. The Risk Evaluation Rulemaking Must Include both Procedural and Substantive Elements to Effect the Purposes of the Statute Congress included a specific mandate to EPA to establish a risk evaluation rulemaking. There is little question that the rule must describe the process by which risk evaluations will be conducted. However, to 3 effect the purposes of the statute, the process described in the rule cannot merely set out timelines or the sequence of the risk evaluation. It must include a clear articulation of the substantive elements of risk evaluation, and more particularly, it must explain how it will apply the principles set out in Section 6(b)(4)(F), Section 26, and other parts of the statute. If Congress had intended the scientific standard of "best available science" or "weight of the scientific evidence" to be incorporated into guidance alone, it would have included them only in Section 26(1) on "policies, procedures and guidance." 3 "[T]he Administrator shall establish, by rule, a process to conduct risk evaluations in accordance with subparagraph (A) " Section 6(b)(4)(A). 5 I Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 The very purpose of the risk evaluation is to develop the evidentiary and scientific basis to enable EPA to complete the risk determination required by statute. That risk determination has substantive impact - it significantly affects conduct, activity or a substantive interest that is the subject of agency regulation. The determination following risk evaluation is a necessary prerequisite for a chemical to proceed to risk management, if warranted. The rule should thus include a clear description of how EPA will undertake risk evaluations in order to meet the new statutory requirements of the LCSA. This includes a description of the scoping process and requirements for a published scope as well as the elements of the risk evaluation itself and the mechanism for gauging adequacy as measured against statutory criteria. III. The Proposed Rule Should Include a Tiered Approach to Risk Evaluation We believe the statute contemplates a tiered approach to risk evaluation and recommend that EPA include a tiered approach in the rule. Under the LCSA, EPA must initiate the risk evaluation "upon designating" a chemical as a high-priority substance. The scope, however, is not required to be published "upon initiation" -- EPA has up to six months following the initiation of the risk evaluation to prepare and publish the scope. Congress intended this six month period to be used for a scoping exercise, where EPA identifies "the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations the Administrator expects to consider in the risk evaluation." This six month period is a "step" between the high priority designation and the publication of the scope. In order for EPA to conduct risk evaluations consistent with the quality required by the LCSA and within the timeframes required, EPA should conduct a screening level evaluation during the scoping phase. During the scoping phase of risk evaluations, tools exist to allow EPA to conduct quantitative screening level analyses of multiple exposure scenarios, as appropriate for consumers, sensitive subpopulations, and the environment. This will allow EPA to have a more tailored focus on those populations and exposures of greatest concern during a refined risk evaluation process. Figure 1 below depicts ACC's recommended approach. 6 I Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 - y 10 Worknlan High-Duality Refined Risk Evaluation High Pricrity Chemicats & DRAFT Chemicals Manufacturer Risk Evaluation Requested EXPOSSURES HAZARD Evaluation incorporating Sections 6 and 26 of the Lautenberg Chemicel Safety Act (LCSA): Scope/Screening Level Risk Evatuation Scientific Standards FINAL Susceprible Weight of Scientific Evidence Evaluations Risk Evaluation Exposures Pupulations or use Certain Conditions of Use Present Do not present an anreasonable risk an unreasonable risk Refined No further risk evaluation risk avaluation No further action; needed RUREMAKING PROCESS COMPLETE the Figure 1. A Two-Step Process for Conducting Risk Evaluations Note: This is a simplified version of the process. A tiered approach, where EPA uses the scoping step (step 1) to conduct a quantitative screening level analysis, will allow EPA to focus its limited resources on more robust refined risk evaluations for only those conditions of use where unreasonable risks cannot be ruled out. Screening-level assessments require less data and information, and are typically deterministic and based on conservative, health protective assumptions and methods. When a screening assessment indicates low risk for a particular condition of use, the Agency should have a high degree of confidence that the potential risks are much lower than the calculation and, therefore, the actual risks are lower and/or perhaps non-existent. However, when a screening-level risk assessment indicates a potential concern for an adverse effect, this does not mean that the actual risks are significant and warrant action. Rather, it indicates the Agency should take a second step in the risk evaluation process to refine the evaluation to more accurately quantify potential risks. The refined risk evaluation (step 2) will require realistic and representative data, higher tier modeling approaches, including probabilistic exposure modeling, and a more comprehensive consideration of human relevance and dose-response relationships. In a refined evaluation, EPA should also consider targeted exposure studies, as well as biomonitoring and environmental monitoring data, to the extent that this information is available and relevant. This approach is consistent with EPA's 2014 Framework for Human Health Risk Assessment to Inform Decision Making (HHRA Framework)4. which also emphasizes the importance of a fit-for-purpose approach to risk evaluation. This approach is also consistent with EPA's exposure assessment guidelines and practices. The concept of a tiered approach and a fit-for-purpose 5 evaluation are woven throughout ACC's recommendations. 4 See tps://www.epa.gov/sites/production/files/2014-12/documents/hhra-framework-final-2014.pdf. 5 See: tps://www.epa.gov/expobox/exposure-assessment-tools-tiers-and-types-screening-level-and-refined. 7 Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 The tiered approach ACC recommends is consistent with the approach EPA took in the problem formulation and initial assessment document for tetrabromobisphenol A (TBBPA.6 In that document, EPA conducted an initial screening level evaluation to support its conceptual model and analysis plan. EPA appropriately used high-end exposure values coupled with the lowest toxicity values to evaluate uses and exposure pathways of potential concern. While EPA did not share the relevant risk evaluation calculations in its public document, the general approach is consistent with that of a screening level risk evaluation. ACC encourages EPA to continue with this approach and to transparently and clearly present quantitative screening level analyses for the conditions of use and exposure scenarios that are part of the conceptual model EPA develops as part of the scoping phase. IV. The Rule Should Clarify the Process for Preparation and Contents of the Scope As noted above, Congress allowed a six month period for preparation of the scope of the risk evaluation, contemplating that time and effort would be needed to move from prioritization to a published scope. The six month period is to enable EPA to identify "the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations the Administrator expects to consider in the risk evaluation." Two things are evident from this language and the time frame afforded: 1) EPA should use this period to evaluate and decide which, if any, potentially exposed or susceptible subpopulations should be included in the risk evaluation (in other words, it need not include all such subpopulations, regardless of size, impact, or relevance); and 2) tEPA has flexibility to actually conduct a full risk evaluation of some or all the potential scenarios set out in the scope. In short, EPA need not include every conceivable condition of use in a risk evaluation. This view is further buttressed by the definition of "conditions of use" in Section 3 of the LCSA, which points to the need for EPA to determine the relevant conditions of use: "the circumstances, as determined by the Administrator, under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of." (Emphasis added). V. The Proposed Rule Should Include a Detailed Description of Substantive Elements of Risk Evaluation The term, "risk evaluation" is not expressly defined in the LCSA. While the term "risk assessment" has been widely used in EPA programs and operationally has clear meaning derived from years of guidance, policies and practices, that term was not used in the statute. Therefore even though it may be reasonable to assume "risk evaluation" may fully equate with the term "risk assessment," given the context of its use (integrating hazard with exposure) in the LCSA, EPA is encouraged to explicitly define and operationalize this term as part of its rulemaking. The term will not have clear meaning until an interpretation is assigned by EPA. We believe the essential elements of a Section 6 and 26 risk evaluation must be articulated in a clear regulatory definition as we discuss below. 6 EPA, Problem Formulation and Initial Assessment Tetrabromobisphenol A and Related Chemicals Cluster Flame Retardants, 2015, available at: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/tsca-work-plan-chemical-problem- formulation-and-2. 8 IPage Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 Section 6(b)(4)(B) of the statute requires EPA to establish, by rule, "a process to conduct risk evaluations." This process is itself required to meet a number of substantive elements described in the LCSA; a risk evaluation must: Be conducted in a manner designed to help the agency determine "whether a chemical substance presents an unreasonable risk of injury to health or the environment;" as set out in Section 6(b)(4)(A). Include consideration of "an unreasonable risk to a potentially exposed or susceptible subpopulation." EPA must identify relevant potentially exposed or susceptible subpopulations relevant to the risk evaluation under conditions of use; Address the specific elements set out in Section 6(b)(4)(F); and Comply with the specific requirements of Section 26, including the best available science, weight of the evidence, and transparency requirements. The very purpose of the risk evaluation is to develop the evidentiary and scientific basis to enable EPA to complete the risk determination required by statute. That risk determination has substantive impact - it significantly affects conduct, activity or a substantive interest that is the subject of agency regulation. The basis for the risk determination thus should be adequately described in the rule itself to offer sufficient notice to the regulated community. This is particularly important for decisions that inform safety and safety determinations. Likewise, decisions that have broad reaching impact should be supported in regulations, not merely through guidance or agency policy. 8 While EPA cannot substitute policy or guidance for a regulatory description of what will constitute a complete and robust risk evaluation, we believe the necessary elements can be developed in this rulemaking in a timely manner. VI. The Proposed Rule Should Ensure Consistency with Section 6(b)(4)(F) As discussed below, Section 6(b)(4)(F) of the LCSA describes five requirements for risk evaluations that shall be considered by the Administrator and must be incorporated into the risk evaluation rulemaking. 7 See, e.g., MST Express v. U.S. Department of Transportation, 108 F.3d 401 (D.C. Cir. 1997). DOT was directed under the Motor Carrier Safety Act (MCSA) to "prescribe regulations establishing a procedure to decide on the safety fitness of owners and operators of commercial motor vehicles." [Emphasis added]. The MCSA stated that implementing regulations would include "a means of deciding whether the owners, operators, and persons meet the safety fitness requirements." DOT promulgated regulations that set out a process for decision making but used guidance to articulate the tests by which the agency would determine whether vehicles met the safety fitness requirements. The court rejected DOT's reliance on guidance because it "failed to carry out its statutory obligation to establish by regulation a means of determining whether a carrier has complied with the safety fitness requirements." 8 As a general matter, "...it seems to be established that "regulations,' 'substantive rules' or 'legislative rules' are those which create law, usually implementary to an existing law." Gibson Wine Co. v. Snyder, 194 F.2d 329, 331 (D.C. Cir. 1952), cited by Brown Express, Inc. v. U.S., 607 F.2d 695, 700 (5th Cir. 1979). A "rule" is defined under Section 2 of the Administrative Procedure Act, in relevant part, as: "the whole or part of an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy or describing the organization, procedure, or practice requirements of an agency." 5 U.S.C. § 551(4). 9 I Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226

What is the name of STEP 2?

ylcn0226

ylcn0226_p0, ylcn0226_p1, ylcn0226_p2, ylcn0226_p3, ylcn0226_p4, ylcn0226_p5, ylcn0226_p6, ylcn0226_p7, ylcn0226_p8, ylcn0226_p9

Refined Risk Evaluation, REFINED RISK EVALUATION

Search 1/19/17 snapshot Assessing and Managing Chemicals under TSCA Contact Us Share Assessing and Managing Chemicals under The Frank R. Lautenberg TSCA Home Chemical Safety for the How EPA Assesses Chemical Safety 2 1st Century Act Assessments for TSCA Work Plan Chemicals On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for Sign up for Current Chemical the 21st Century Act which amends the Toxic TSCA and Risk Reduction Activities Other Substances Control Act (ISCA), the Nation's Chemical ChemView primary chemicals management law. Safety News Chemical Data Reporting The new law, which received bipartisan support in both the U.S. House of Representatives and Getemail alerts the Senate, includes much needed improvements such as: Enter email address sign up Mandatory requirement for EPA to evaluate existing chemicals with clear and enforceable deadlines; New risk-based safety standard; Increased public transparency for chemical information; and Recent Consistent source of funding for EPA to carry additions out the responsibilities under the new law. Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 American" Chemistry Council August 24, 2016 Wendy Cleland-Hamnett Director, Office of Pollution Prevention and Toxics Environmental Protection Agency 1200 Pennsylvania Ave. NW Washington, DC 20460-0001 Sent electronically to www.regulations.gov docket # EPA-HQ-OPPT-2016-0400 Re: ACC Comments to Inform EPA's Rulemaking on the Conduct of Risk Evaluations under the Lautenberg Chemical Safety Act Dear Ms. Cleland-Hamnett: The American Chemistry Council (ACC¹ appreciates the opportunity to provide input to the Office of Pollution Prevention and Toxics to inform the Agency's development of a risk evaluation rulemaking under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (LCSA). ACC has a long-standing commitment to a robust, science-based approach to evaluation of human and environmental risk. ACC is committed to the effective implementation of the LCSA and supports a workable, rigorous process that allows for timely, high quality reviews. Given the strong emphasis on a risk-based approach in the LCSA, the Section 6(b)(4) rulemaking is particularly important because it will guide the conduct of future risk evaluations that will then inform risk management activities. ACC is committed to being a constructive stakeholder throughout the implementation of LCSA. We will continue to draw from the breadth and depth of our member companies' expertise to ensure that our recommendations are not only science-based, but also allow for the efficient and effective implementation of the LCSA. In doing so, ACC will continue to consider the high quality science standards in the LCSA as well as the timeframes and deadlines imposed therein. The enclosed recommendations were developed with these important considerations in mind. If EPA has any questions, please contact me at nancy [email protected] or 202-249-6417. Sincerely, Nancy B. Beck, PhD, DABT Senior Director, Regulatory and Technical Affairs Cc: Jim Jones, OCSPP Assistant Administrator Louise Wise, Deputy Assistant Administrator Jeffery Morris, Deputy Director for Programs, OPPT Tala Henry, Director, Risk Assessment Division, OPPT 1 The American Chemistry Council (ACC) represents the leading companies engaged in the business of chemistry. More information about ACC is presented in the body of our comments. 1 IPage Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 American Chemistry Council Initial Input to U.S. Environmental Protection Agency In Regard to the Risk Evaluation Rule under the Lautenberg Chemical Safety Act Table of Contents I. Introduction and Executive Summary 4 II. The Risk Evaluation Rulemaking Must Include both Procedural And Substantive Elements to Effect the Purposes of the Statute 5 III. The Proposed Rule Should Include a Tiered Approach to Risk Evaluation 6 IV. The Rule Should Clarify the Process for Preparation and Contents of the Scope 8 V. The Proposed Rule Should Include a Detailed Description of Substantive Elements of Risk Evaluation 8 VI. Proposed Rule Should Ensure Consistency with Section 6(b)(4)(F) 9 a. Integration and Assessment of Information Relevant to Risks and Information on Potentially Exposed and Susceptible Populations 10 i. Conditions of Use That are Relevant 10 ii. Potentially Exposed or Susceptible Subpopulations 10 b. Aggregate and Sentinel Exposures 12 i. Aggregate Exposures 12 ii. Sentinel Exposures 12 c. Exposure Assessment 13 d. Weight of the Evidence 14 VII. The Proposed Rule Should Incorporate Section 26(h) Scientific Standards 14 a. Fit-for-Purpose Approach 15 b. Consideration of Relevant Information 16 i. Improving Hazard Assessment 16 ii. Improving Dose Response Assessment 17 iii. Reliance on Guidance 17 c. Importance of High Quality Risk Characterization 18 d. Clearly Addressing Variability and Uncertainty 18 e. Ensuring Appropriate Peer Review and Forming a Science Advisory Committee on Chemicals 19 21 Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 VIII. The Proposed Rule Should Implement a Weight of the Scientific Evidence (WoE) Approach 20 a. Systematic Review is Required 20 i. Development of a Protocol 21 ii. Search Strategy 21 iii. Transparency 21 b. A Systematic Review is Not Automatically a WoE Assessment 21 c. WoE and Systematic Review for Screening Level Risk Evaluations 22 d. WoE and Systematic Review for Refined Risk Evaluations 22 e. Strength of Evidence is Not the Same as WoE 23 IX. EPA Should Make Information Available Consistent with Section 26(j) 24 X. EPA Should Use Reasonably Available Information and CBI Consistent with Section 26(k) 24 XI. EPA Should Utilize Fit-for-Purpose Exposure Evaluation Tools 25 XII. The Requirements of Sections 6 and 26 Apply to Environmental Risk Evaluations 26 a. Advancing Models for Environmental Risks 27 b. Improving Data Sourcing, Generation, and Evaluation 27 c. Persistent, Bioaccumulative and Toxic (PBT) Substances 28 XIII. EPA Should Leverage International and Inter-Agency Cooperation 28 XIV. Incorporating High Throughput Tools and Alternative Methods 29 XV. Stakeholders and EPA Must Be Held to the Same High Standard 30 APPENDIX A: ACC's Principles for Improving Chemical Hazard and Risk Assessment 31 APPENDIX B: Improving Hazard Assessment 32 APPENDIX C: Improving Does Response Assessment 33 APPRNDIX D: Improving Risk Characterization 35 APPENDIX E: Ensuring Robust Peer Review 37 APPENDIX F: Exposure Modeling Tools 39 APPENDIX G: Additional Information on the ECETOC TRA 41 3 I P a 3 e Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 I. Introduction and Executive Summary The American Chemistry Council (ACC)2 is pleased to provide the U.S. Environmental Protection Agency (EPA) this initial input on the Lautenberg Chemical Safety Act's (LCSA) requirement for the Agency to establish, by rule, the process for conducting risk evaluations. ACC appreciates EPA's early efforts to obtain input from stakeholders at its August 9, 2016, public meeting. We also appreciate EPA's solicitation of written comments to be entered into the docket, well in advance of publication of the proposed rule. Our comments both clarify, as well as supplement and expand upon, the oral comments we presented at the August 9 meeting. ACC strongly supported Congress' efforts to update and reform the Toxic Substances Control Act (TSCA). We believe that high quality risk evaluation, using best available science and weight of the evidence (WoE), is at the very heart of the LCSA. Effective and efficient risk evaluations will help deliver the results intended by Congress. Section 6(b)(4)(B) of the statute requires EPA to establish, by rule, "a process to conduct risk evaluations.' This certainly should include a description of the sequence of events, timelines, opportunities for public comments and peer review. Both Sections 6 and 26 of the LCSA outline various substantive elements that apply to and inform risk evaluation. A risk evaluation must: Be conducted in a manner designed to determine "whether a chemical substance presents an unreasonable risk of injury to health or the environment;" as set out in Section 6(b)(4)(A); Identify whether there exists "an unreasonable risk to a potentially exposed or susceptible subpopulation." EPA must identify potentially exposed or susceptible subpopulations relevant to the risk evaluation under conditions of use; Address the specific elements set out in Section 6(b)(4)(F); and Comply with the specific requirements of Section 26, including the best available science, weight of the evidence, and transparency requirements. Because these elements are at the core of the risk evaluation process, and affect risk management measures, they are substantive and should be described in adequate detail in the regulation. In general, where risk evaluation elements are now required by statute, EPA should apply them uniformly and universally reflecting them in the body of the regulation. The recommendations provided by ACC in these comments address screening and refined risk evaluations and are meant to apply to both human health and environmental risks. Specific tools, testing methods, databases, and the like may develop over time, or course, and can be updated as necessary in policies, 2 The American Chemistry Council (ACC) represents the leading companies engaged in the business of chemistry. ACC members apply the science of chemistry to make innovative products and services that make people's lives better, healthier and safer. ACC is committed to improved environmental, health and safety performance through Responsible Care common sense advocacy designed to address major public policy issues, and health and environmental research and product testing. The business of chemistry is a $797 billion enterprise and a key element of the nation's economy. It is the nation's largest exporter, accounting for fourteen percent of all U.S. exports. Chemistry companies are among the largest investors in research and development. Safety and security have always been primary concerns of ACC members, and they have intensified their efforts, working closely with government agencies to improve security and to defend against any threat to the nation's critical infrastructure. 4 Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 procedures and guidance. Our comments strive to make these differentiations and explain where particular elements of risk evaluation should be included in the rule proper. Specifically, our recommendations suggest definitions, and procedural steps and elements that will allow EPA to ensure that risk evaluations are consistent with the statutory requirements for EPA to use the best available science and WoE approaches. The recommendations also include definitions and procedural steps are not expected to change over time. ACC has referenced each of our suggestions to an existing EPA guidance, a National Academies (NAS) report, or another authoritative body or peer reviewed report. For instance, the recommendations in EPA's 2000 Risk Characterization Handbook still represent best practices today. Adding adequate definitions and explanation to the rule is particularly important to achieving incorporation of statutory requirements. We also note that in addition to Section 6, Sections 26(h), 26(i), 26(j), and 26(k) of the LCSA each present legal requirements that are applicable to the risk evaluation. EPA will now need to provide a level of transparency regarding not only the inputs, but also the methods of the analysis, including clear descriptions of uncertainties and variability. EPA should leverage information from other jurisdictions where data and information is applicable and of sufficient quality to meet the science standards in the LCSA. Incorporating these elements into the rulemaking creates a better platform for clear and consistent articulation of the Agency's understanding of statutory requirements, and will better support consistent and uniform application of the elements of risk evaluation. It is critically important that EPA engage the public as EPA plans, scopes, and conducts risk evaluations. Industry scientists often have unique insight and experience with their companies' chemistries and collectively have a large body of knowledge of risk assessment processes globally, including an understanding of potential human health and environmental impacts. ACC encourages EPA to leverage this knowledge and engage early (well before draft risk evaluations are released) and frequently with industry throughout the risk evaluation process. II. The Risk Evaluation Rulemaking Must Include both Procedural and Substantive Elements to Effect the Purposes of the Statute Congress included a specific mandate to EPA to establish a risk evaluation rulemaking. There is little question that the rule must describe the process by which risk evaluations will be conducted. However, to 3 effect the purposes of the statute, the process described in the rule cannot merely set out timelines or the sequence of the risk evaluation. It must include a clear articulation of the substantive elements of risk evaluation, and more particularly, it must explain how it will apply the principles set out in Section 6(b)(4)(F), Section 26, and other parts of the statute. If Congress had intended the scientific standard of "best available science" or "weight of the scientific evidence" to be incorporated into guidance alone, it would have included them only in Section 26(1) on "policies, procedures and guidance." 3 "[T]he Administrator shall establish, by rule, a process to conduct risk evaluations in accordance with subparagraph (A) " Section 6(b)(4)(A). 5 I Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 The very purpose of the risk evaluation is to develop the evidentiary and scientific basis to enable EPA to complete the risk determination required by statute. That risk determination has substantive impact - it significantly affects conduct, activity or a substantive interest that is the subject of agency regulation. The determination following risk evaluation is a necessary prerequisite for a chemical to proceed to risk management, if warranted. The rule should thus include a clear description of how EPA will undertake risk evaluations in order to meet the new statutory requirements of the LCSA. This includes a description of the scoping process and requirements for a published scope as well as the elements of the risk evaluation itself and the mechanism for gauging adequacy as measured against statutory criteria. III. The Proposed Rule Should Include a Tiered Approach to Risk Evaluation We believe the statute contemplates a tiered approach to risk evaluation and recommend that EPA include a tiered approach in the rule. Under the LCSA, EPA must initiate the risk evaluation "upon designating" a chemical as a high-priority substance. The scope, however, is not required to be published "upon initiation" -- EPA has up to six months following the initiation of the risk evaluation to prepare and publish the scope. Congress intended this six month period to be used for a scoping exercise, where EPA identifies "the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations the Administrator expects to consider in the risk evaluation." This six month period is a "step" between the high priority designation and the publication of the scope. In order for EPA to conduct risk evaluations consistent with the quality required by the LCSA and within the timeframes required, EPA should conduct a screening level evaluation during the scoping phase. During the scoping phase of risk evaluations, tools exist to allow EPA to conduct quantitative screening level analyses of multiple exposure scenarios, as appropriate for consumers, sensitive subpopulations, and the environment. This will allow EPA to have a more tailored focus on those populations and exposures of greatest concern during a refined risk evaluation process. Figure 1 below depicts ACC's recommended approach. 6 I Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 - y 10 Worknlan High-Duality Refined Risk Evaluation High Pricrity Chemicats & DRAFT Chemicals Manufacturer Risk Evaluation Requested EXPOSSURES HAZARD Evaluation incorporating Sections 6 and 26 of the Lautenberg Chemicel Safety Act (LCSA): Scope/Screening Level Risk Evatuation Scientific Standards FINAL Susceprible Weight of Scientific Evidence Evaluations Risk Evaluation Exposures Pupulations or use Certain Conditions of Use Present Do not present an anreasonable risk an unreasonable risk Refined No further risk evaluation risk avaluation No further action; needed RUREMAKING PROCESS COMPLETE the Figure 1. A Two-Step Process for Conducting Risk Evaluations Note: This is a simplified version of the process. A tiered approach, where EPA uses the scoping step (step 1) to conduct a quantitative screening level analysis, will allow EPA to focus its limited resources on more robust refined risk evaluations for only those conditions of use where unreasonable risks cannot be ruled out. Screening-level assessments require less data and information, and are typically deterministic and based on conservative, health protective assumptions and methods. When a screening assessment indicates low risk for a particular condition of use, the Agency should have a high degree of confidence that the potential risks are much lower than the calculation and, therefore, the actual risks are lower and/or perhaps non-existent. However, when a screening-level risk assessment indicates a potential concern for an adverse effect, this does not mean that the actual risks are significant and warrant action. Rather, it indicates the Agency should take a second step in the risk evaluation process to refine the evaluation to more accurately quantify potential risks. The refined risk evaluation (step 2) will require realistic and representative data, higher tier modeling approaches, including probabilistic exposure modeling, and a more comprehensive consideration of human relevance and dose-response relationships. In a refined evaluation, EPA should also consider targeted exposure studies, as well as biomonitoring and environmental monitoring data, to the extent that this information is available and relevant. This approach is consistent with EPA's 2014 Framework for Human Health Risk Assessment to Inform Decision Making (HHRA Framework)4. which also emphasizes the importance of a fit-for-purpose approach to risk evaluation. This approach is also consistent with EPA's exposure assessment guidelines and practices. The concept of a tiered approach and a fit-for-purpose 5 evaluation are woven throughout ACC's recommendations. 4 See tps://www.epa.gov/sites/production/files/2014-12/documents/hhra-framework-final-2014.pdf. 5 See: tps://www.epa.gov/expobox/exposure-assessment-tools-tiers-and-types-screening-level-and-refined. 7 Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 The tiered approach ACC recommends is consistent with the approach EPA took in the problem formulation and initial assessment document for tetrabromobisphenol A (TBBPA.6 In that document, EPA conducted an initial screening level evaluation to support its conceptual model and analysis plan. EPA appropriately used high-end exposure values coupled with the lowest toxicity values to evaluate uses and exposure pathways of potential concern. While EPA did not share the relevant risk evaluation calculations in its public document, the general approach is consistent with that of a screening level risk evaluation. ACC encourages EPA to continue with this approach and to transparently and clearly present quantitative screening level analyses for the conditions of use and exposure scenarios that are part of the conceptual model EPA develops as part of the scoping phase. IV. The Rule Should Clarify the Process for Preparation and Contents of the Scope As noted above, Congress allowed a six month period for preparation of the scope of the risk evaluation, contemplating that time and effort would be needed to move from prioritization to a published scope. The six month period is to enable EPA to identify "the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations the Administrator expects to consider in the risk evaluation." Two things are evident from this language and the time frame afforded: 1) EPA should use this period to evaluate and decide which, if any, potentially exposed or susceptible subpopulations should be included in the risk evaluation (in other words, it need not include all such subpopulations, regardless of size, impact, or relevance); and 2) tEPA has flexibility to actually conduct a full risk evaluation of some or all the potential scenarios set out in the scope. In short, EPA need not include every conceivable condition of use in a risk evaluation. This view is further buttressed by the definition of "conditions of use" in Section 3 of the LCSA, which points to the need for EPA to determine the relevant conditions of use: "the circumstances, as determined by the Administrator, under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of." (Emphasis added). V. The Proposed Rule Should Include a Detailed Description of Substantive Elements of Risk Evaluation The term, "risk evaluation" is not expressly defined in the LCSA. While the term "risk assessment" has been widely used in EPA programs and operationally has clear meaning derived from years of guidance, policies and practices, that term was not used in the statute. Therefore even though it may be reasonable to assume "risk evaluation" may fully equate with the term "risk assessment," given the context of its use (integrating hazard with exposure) in the LCSA, EPA is encouraged to explicitly define and operationalize this term as part of its rulemaking. The term will not have clear meaning until an interpretation is assigned by EPA. We believe the essential elements of a Section 6 and 26 risk evaluation must be articulated in a clear regulatory definition as we discuss below. 6 EPA, Problem Formulation and Initial Assessment Tetrabromobisphenol A and Related Chemicals Cluster Flame Retardants, 2015, available at: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/tsca-work-plan-chemical-problem- formulation-and-2. 8 IPage Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226 Section 6(b)(4)(B) of the statute requires EPA to establish, by rule, "a process to conduct risk evaluations." This process is itself required to meet a number of substantive elements described in the LCSA; a risk evaluation must: Be conducted in a manner designed to help the agency determine "whether a chemical substance presents an unreasonable risk of injury to health or the environment;" as set out in Section 6(b)(4)(A). Include consideration of "an unreasonable risk to a potentially exposed or susceptible subpopulation." EPA must identify relevant potentially exposed or susceptible subpopulations relevant to the risk evaluation under conditions of use; Address the specific elements set out in Section 6(b)(4)(F); and Comply with the specific requirements of Section 26, including the best available science, weight of the evidence, and transparency requirements. The very purpose of the risk evaluation is to develop the evidentiary and scientific basis to enable EPA to complete the risk determination required by statute. That risk determination has substantive impact - it significantly affects conduct, activity or a substantive interest that is the subject of agency regulation. The basis for the risk determination thus should be adequately described in the rule itself to offer sufficient notice to the regulated community. This is particularly important for decisions that inform safety and safety determinations. Likewise, decisions that have broad reaching impact should be supported in regulations, not merely through guidance or agency policy. 8 While EPA cannot substitute policy or guidance for a regulatory description of what will constitute a complete and robust risk evaluation, we believe the necessary elements can be developed in this rulemaking in a timely manner. VI. The Proposed Rule Should Ensure Consistency with Section 6(b)(4)(F) As discussed below, Section 6(b)(4)(F) of the LCSA describes five requirements for risk evaluations that shall be considered by the Administrator and must be incorporated into the risk evaluation rulemaking. 7 See, e.g., MST Express v. U.S. Department of Transportation, 108 F.3d 401 (D.C. Cir. 1997). DOT was directed under the Motor Carrier Safety Act (MCSA) to "prescribe regulations establishing a procedure to decide on the safety fitness of owners and operators of commercial motor vehicles." [Emphasis added]. The MCSA stated that implementing regulations would include "a means of deciding whether the owners, operators, and persons meet the safety fitness requirements." DOT promulgated regulations that set out a process for decision making but used guidance to articulate the tests by which the agency would determine whether vehicles met the safety fitness requirements. The court rejected DOT's reliance on guidance because it "failed to carry out its statutory obligation to establish by regulation a means of determining whether a carrier has complied with the safety fitness requirements." 8 As a general matter, "...it seems to be established that "regulations,' 'substantive rules' or 'legislative rules' are those which create law, usually implementary to an existing law." Gibson Wine Co. v. Snyder, 194 F.2d 329, 331 (D.C. Cir. 1952), cited by Brown Express, Inc. v. U.S., 607 F.2d 695, 700 (5th Cir. 1979). A "rule" is defined under Section 2 of the Administrative Procedure Act, in relevant part, as: "the whole or part of an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy or describing the organization, procedure, or practice requirements of an agency." 5 U.S.C. § 551(4). 9 I Page Source: https://www.industrydocuments.ucsf.edu/docs/ylcn0226

which are viewed as the indicators of exposure?

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persistence and bioaccumulation

endpoints, criteria are similarly available for both acute and chronic classification. The use of one common system allows for appropriate assessment of all substances. GHS classification information is readily available for all substances, as U.S. manufacturers have developed GHS classifications for their products to meet international requirements. ACC's support of the GHS criteria for purposes of this prioritization tool is not a categorical endorsement of the GHS criteria for any other purpose. ACC has been an active participant in the development of GHS and supports the system in principle. The GHS has not been broadly implemented to date in the U.S., although the Occupational Safety and Health Administration (OSHA) has indicated an intent to publish a regulation applying GHS in the workplace. ACC's December 29, 2009, comments on OSHA's proposed rule to modify the existing Hazard Communication Standard (HCS) to reflect the GHS urged that implementation of the GHS adhere to certain principles (e.g., continued application of the "Building Block Approach" of the Purple Book). ACC made specific recommendations concerning details of the Hazard Classification definitions, cut-off values, among others. ACC stands behind those comments. In ACC's view, the use of GHS criteria in a screening-level prioritization of chemicals can materially assist in determining which chemicals receive additional evaluation by the Environmental Protection Agency, but does not necessarily preclude the use of other appropriate, applicable criteria developed under other systems. To classify a chemical in a hazard based priority ranking where there is not direct data on the chemical, EPA can employ the full range of approaches, such as QSAR, SAR, read- across and other modeling tools in which EPA has confidence based on molecular structure. In those situations where there still remains insufficient information on either environmental or human health hazards, the chemical would be classified as "high" for its environmental or health ranking. 1. Environmental Ranking Table 1 provides a summary of how GHS criteria could be logically used for chemical management prioritization. Table 1. Environmental Safety - Hazard Ranking GHS Classification - Ranking Environmental Rank Environmental Score Acute I or Chronic I or Insufficient Information to High 4 Classify Acute II or Chronic II Medium High 3 Acute III or Chronic III/IV or Medium 2 none Not classified Low 1 August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 2. Human Health Ranking Table 2. Human Health - Hazard Ranking Health Rank GHS Classification - Human Health Ranking Score GHS CMR Cat 1a, 1b; OR Repeat Dose </= 10 mg/kg/day (oral); </= 20 mg/kg/day (dermal); </= 50 ppm/6hr/day (gas inhalation); High 4 <<= 0.2 mg/1/6h/day (vapour inhalation); </= 0.02 mg/l/6h/day (dust mist fume inhal). OR insufficient information to classify GHS CMR Cat 2; OR Repeat Dose 10 - 100 mg/kg/day (oral); 20 - 200 mg/kg/day (dermal); Medium High 50 - 250 ppm/6hr/day (gas inhalation); 3 0.2 - 1.0 mg/l/6h/day (vapour inhalation); 0.02 - 0.2 mg/l/6h/day (dust mist fume inhal). Not carcinogen/mutagen/repro/develop;OR Repeat Dose 100 - 1000 mg/kg/day (oral); 200 - 2000 mg/kg/day (dermal); Medium 250 - 1000 ppm/6hr/day (gas inhalation); 2 1.0 - 5.0 mg/l/6h/day (vapour inhalation); 0.2 - 1.0 mg/l/6h/day (dust mist fume inhal). Not carcinogen/mutagen/repro/develop; OR Repeat Dose >1000 mg/kg/day (oral); > 2000 mg/kg/day (dermal); Low > 1000 ppm/6hr/day (gas inhalation); 1 >5.0 mg/l/6h/day (vapour inhalation); > 1.0 mg/l/6h/day (dust mist fume inhal). It is important to note that specific concerns about children's health (specifically potential hazards and adverse effects on the nervous system) and those caused by endocrine disruption mechanisms are addressed in this prioritization process: The GHS CMR "R" classification includes specific evaluation of effects on development in utero and upon growth, maturation and reproduction. ("R" stands for reproductive toxicity and includes adverse effects on sexual function and fertility, as well as developmental toxicity in offspring). Endocrine activity is not a distinct toxicological hazard per se, but rather a measure of a compound's ability to interact with components of the endocrine system. The prioritization process evaluates data and information on relevant apical tests, including tests for reproduction and developmental toxicity (potential endocrine pathways). Thus, even if specific August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 screening for potential endocrine activity has not yet been conducted on certain compounds, hazard identification based on observable outcomes from apical toxicity tests (e.g., outcomes such as pathologic states indicative of disease conditions) covers all modes of action, including endocrine pathways. The toxicity information evaluated (CMR and repeat dose toxicity) is directly relevant to evaluating potential hazards to all individuals, including children. Such data typically includes: 1) identification and definition of possible hazards upon all major organ systems from both acute and repeated exposures, including the nervous system; 2) detection of potential hazards arising from in utero exposures, including possible effects on the nervous system; 3) evaluation of potential of a substance to affect reproduction; and 4) evaluation of the potential of a substance to damage DNA. Integration of Hazard Elements: Each of the environmental and human health classifications is assigned a numeric value based upon its ranking, with 1 being the lowest value and 4 the highest. The greatest ranking (highest hazard potential score) of either Environmental or Human Health is used in a substance- specific priority ranking. The numeric value does not imply relative weighting, but rather a numerical order of priority. B. Exposure Potential Ranking The screening method allows for an initial indication of the extent of exposure potential by considering: 1. The chemical's uses and use pattern(s) 2. Production volume as a first pass indicator of relative emission/release potential since magnitude and route (i.e. air, water, soil) of emissions is not available for all substances. 3. Persistence and bioaccumulation characteristics of the substance. Together the 3 elements are used to rank exposure potential. 1. Use Patterns The proposed approach applies the most current 2006 TSCA Inventory Update Reporting rule (IUR, now called the Chemical Data Reporting rule (CDR) data. To keep the initial prioritization simple and transparent, the approach "bins" different use patterns to align with general exposure potential - intermediates, industrial use, commercial use and consumer use. These patterns are the same as those reported in the IUR and are consistent with REACH exposure categories (intermediates, worker, professional, consumer). Chemicals with consumer product use are likely to have widespread potential for general population exposures and are given high priority ranking within the approach. For the initial prioritization approach, child specific products are captured under general consumer products and all consumer products are weighted equally (see additional discussion below under Second Tier Considerations). Intermediates will have low general population exposures, since these substances are consumed, by definition, within the workplace. Therefore, they are given the lowest priority ranking within the approach. In the context of the proposed approach, the intermediates category includes both intermediates and non-isolated intermediates. A chemical used in multiple use patterns is August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 assigned the priority of the highest use, e.g., a chemical in both industrial and commercial uses would be assigned the commercial Medium-High rank. Table 3. Use Patterns - Exposure Ranking Use Pattern Ranking Use Pattern Score Consumer High 4 Commercial Medium-High 3 Industrial Medium 2 Intermediates Low 1 The IUR Definitions of these terms are (40 CFR 710.3, 710.43): "consumer use" means the use of a chemical substance or a mixture containing a chemical substance (including as part of article) when sold to or made available to consumers for their use. "commercial use" means the use of a chemical substance or a mixture containing a chemical substance (including as part of an article) in a commercial enterprise providing saleable goods or services. "industrial use" means use at a site at which one or more chemical substances or mixtures are manufactured (including imported). "intermediate" means any chemical substance: which is intentionally removed from the equipment in which it is manufactured, and which either is consumed in whole or in part in chemical reaction(s) used for the intentional manufacture of other chemical substance(s) or mixture(s), or is intentionally present for the purpose of altering the rate of such chemical reaction(s) "non-isolated intermediate" means any intermediate that is not intentionally removed from the equipment in which is it manufactured, including the reaction vessel in which it is manufactured, equipment which is ancillary to the reaction vessel, and any equipment through which the substance passes during a continuous flow process, but not including tanks or other vessels in which the substance is stored after its manufacture. 2. Production Volume Recognizing that detailed exposure information will not be available for all substances to be screened, the proposed approach uses production volume as an indicator of exposure, which is widely used in many prioritization schemes. As production volume is just a rough surrogate of emissions, ACC suggests only very broad categories, covering about two orders of magnitude each. It may be useful to consider how additional exposure estimates may be applied in the second tier assessment. Table 4. Production Volume as Emission Surrogate - Exposure Ranking Production Volume as Emission Surrogate Ranking Volume Score >= 100,000,000 lbs national aggregate High 4 1,000,000 lbs to < 100,000,000 lbs national Medium - High 3 aggregate August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 >= 25,000 lbs to < 1,000,000 lbs national Medium 2 aggregate < 25,000 lbs (below IUR site reporting limit) Low 1 3. Persistence and Bioaccumulation Persistence and bioaccumulation are viewed as indicators of exposure, and therefore are considered under the exposure axis of the approach. A persistent substance that is emitted to the environment at the same rate as a non-persistent substance with similar partitioning properties will result in higher exposure to humans and the environment. In fact, multimedia modeling clearly indicates that environmental persistence in the compartment to which a substance partitions is a good indicator of human exposure potential (MacLeod & McKone et al. 2004). Similarly, substances that are not subject to biotransformation by higher organisms will exhibit a high bioaccumulation potential that results in higher exposures via the food chain (Arnot et al. 2010). Therefore, it is recommended to apply the proposed persistence and bioaccumulation criteria in assessment of exposure potential as described below. The persistent and bioaccumulative (P&B) criteria of the proposed approach are targeted toward organic chemicals. Separate assessment criteria are likely needed for P&B evaluation for inorganics/metals, as in the approach taken by Canada's Chemical Management Program (CMP). For assessing persistence, based upon recent expert consensus (Boethling et al., 2009) it is recommended to distinguish persistent from non-persistent chemicals using the following criteria: Volatile chemicals can be defined using a vapor pressure cut-off (i.e., > 1000 Pa) For volatile chemicals, persistent versus non-persistent chemicals are differentiated using a half-life cut-off in air (e.g., a substance is not persistent if air half life is < 2 days). For non-volatile chemicals, non-persistent substances can be defined as substances that are deemed: readily or inherently biodegradable using standard biodegradation tests (OECD 301, 302, 306 test guidelines) or SAR or read across from measured data on a related substance, show an equivalent degree of degradation (i.e. >20% in 28 days) via an abiotic degradation mechanism such as photolysis (OECD 316) or hydrolysi (OECD 111), evaluation of simulation data from transformation in soil, marine water/sediment, brackish water/sediment, surface water/sediment, oceanic water die away (e.g. OECD 308/309) have half lives below 180 days, OR if data are lacking, evaluation via BIOWIN model (EPIWEB 4) Non-volatile substances that are not biodegradable or subject to abiotic losses based on the above criteria would be considered persistent. For assessing bioaccumulation, the key question for screening is the potential for biomagnification based on recent expert consensus (Gobas et al. 2009). To determine if a substance has the potential to biomagnify the following metrics have been agreed: Trophic Magnification Factor (TMF)>1, fish Biomagnification Factor (BMF)>1 fish Bioaccumulation Factor (BAF)/Bioconcentration Factor (BCF) > 5000. These metrics can be August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 derived using lab or field measurements (where available) or recently improved computational models that are included in EPA's EPIWEB model that can be freely downloaded at www.epa.gov/oppt/exposure/pubs/episuite.htm. This approach allows all organics to be addressed and is a scientifically updated version of the approach used in Canada's CMP. Based on the above recommendations, substances can be grouped with regard to persistence and bioaccumulation as follows: Table 5. Persistence and Bioaccumulation - Exposure Ranking Persistence and P&B Ranking P&B Score Bioaccumulation Persistent and High 5 Bioaccumulative Persistent and Not Medium 3 Bioaccumulative OR Not Persistent and Bioaccumulative Not Persistent and Not Low 1 Bioaccumulative Integration of Exposure Elements: As demonstrated in the tables, each factor (use pattern, P&B, and production volume) would be assigned a numeric score based upon its ranking. All 3 factors are added to arrive at an overall value. These values are then separated into categories from low to high exposure potential. A proposed "banding" approach is illustrated in Table 6. Table 6. Integration of Exposure Rankings Combined Score - All 3 Exposure Rank Exposure Ranking elements Score 11 13 High 5 9 10 Medium High 4 7 8 Medium 3 5 6 Medium Low 2 3 4 Low 1 Overall Priority Grouping: In the overall approach, both hazard and exposure elements are considered when placing a substance in a risk-based prioritization ranking. The overall prioritization score for priority grouping and risk evaluation is based on the combined consideration of the hazard and exposure rankings. Priority Groups 7, 8, and 9 are deemed High Priority; Priority Groups 4, 5, and 6 are Medium Priority; and Priority Groups 2 and 3 are Low Priority. August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 Review and Comment: It is important that screening be done in an open and transparent way and that the best available information be used. When screening for thousands of chemicals, EPA may not have access to all available information. The process should provide an opportunity for review and comment on initial rankings and an opportunity to submit additional relevant data and information to update proposed rankings with improved information. III. Second Tier Considerations: After the initial screening, some substances within individual priority groupings may require further rank ordering, particularly where a large number of chemicals are in the same priority group. Listed below are the types of information that will be useful to consider in this Second Tier rank ordering: Biomonitoring/Environmental Monitoring Data: Mere detection of chemicals in humans or the environment, i.e., "found in biomonitoring (CDC), found in water (NCOD), and found in air", while providing an indication of exposure, does not provide a useful criterion for exposure potential because almost any industrial or commercial chemical could be detected at trace levels, given increasingly sensitive analytical methods. Therefore, detection alone primarily reflects only the fact that a specific chemical was included in a measurement program. This criterion will also tend to bias the prioritization of chemicals for which well-established analytical methods are available. Consequently, this criterion is not used in the initial prioritization scheme. However, within a particular priority grouping, reliable monitoring information should be considered for Second Tier rank ordering within a quantitative process that assesses if the data is above a level of concern (i.e., places it in a risk context). Use in Children's Products: Protection of childrens' health is a top priority and, in the initial ranking, child-specific products are captured under general consumer products and all consumer products are weighted equally. The specific IUR reporting of information on chemical use in products intended for children would be considered further within a particular priority grouping for Second Tier rank ordering, noting the following points: the IUR definition is based upon use in a child specific product rather than child specific exposure potential¹ (see below). Without knowing a specific product type, it is difficult to understand if 1 IUR definition (Federal Register Volume 75, Number 156, Friday August 30, 2010, p. 49686): Intended for use by children means the chemical substance or mixture is used in or on a product that is specifically intended for use by children age 14 or younger. A chemical substance or mixture is intended for use by children when the submitter answers "yes" to at least on of the following questions for the product into which the submitter's chemical substance or mixture is incorporated: (1) Is the product commonly recognized (i.e., by a reasonable person) as being intended for children age 14 or younger? (2) Does the manufacturer of the product state through product labeling or other written materials that the product is intended for or will be used by children age 14 or younger? (3) Is the advertising, promotion, or marketing of the product aimed at children age 14 or younger? August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 potential child exposure is greater than for a non-child specific product. For example, how does child exposure to a general use cleaner compare to exposure from use in a child's raincoat. In the VCCEP assessments, there are examples for inhalation exposures where estimates of passive child exposure during adult product use exceeded conservative estimates of child exposure during active use of a child-specific product (such as a hobby product) - differences were related to the amount of product used and substance concentration within the product (MEK VCCEP Submission). the IUR definition targets children age 14 and younger. Younger children may be exposed to a variety of non-child specific products that are in general household use. Older children may be exposed to a variety of additional products. the IUR information request is targeted to manufacturers, which may not have direct knowledge of all uses, particularly the presence in products for specific subpopulations, such as children. Therefore, it is not clear that the information requested for the IUR information would be consistently available across all substances being screened. Ideally, this information should be requested from formulators of child-specific products. Therefore, for the initial prioritization approach, which represents a broad, unrefined categorization, child specific products are captured under general consumer products and all consumer products are weighted equally. The IUR information on child specific use would be utilized within a particular priority grouping for Second Tier rank ordering. If the IUR information is utilized, it is important that the limitations above be considered in its application. Emissions Data: Production volume, which is readily available for substances, is used in this proposed approach, but only serves as a surrogate for environmental emissions. For further prioritization, data or estimates of environmental emissions can be used to refine prioritization. Estimates of environmental emissions will be available for some substances (e.g., TRI data). When TRI data are utilized it should be recognized that it addresses only emissions that result from industrial and not wide dispersive uses. In other cases, emissions estimates can be developed as a percentage of production volume based upon consideration of use categories. Within a particular priority grouping, available emissions information can be considered for Second Tier rank ordering, with the understanding that emissions information is not an indicator of actual exposure. Similarly, non-isolated system intermediates, by definition, would have de minimis exposure potential. Therefore, this IUR information could be considered within a particular priority grouping for Second Tier rank ordering. International Risk Management Actions: An initial screening approach for chemical prioritization should be based upon consistent application of specific hazard and exposure science elements that define risk potential. The hazard and exposure elements should be applicable across all substances being evaluated. For initial screening, existence of international risk management action plans should not be a factor that determines priority grouping. Risk management plans may be based upon many factors, including political drivers. It is unclear how factors, their relative weighting, and the rigor of the evaluation may vary across agencies and substances. For initial screening August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 purposes, the same science-based criteria should be used to rank all substances. Consideration of existing international risk management plans could be utilized to check the functioning of the approach and could be considered within a particular priority grouping for Second Tier rank ordering with the possible effect of moving a chemical up in a grouping if actions are being taken internationally. IV. Summary ACC's prioritization approach is an example of a risk-based screening prioritization process that implements the general principles outlined at the outset of this document. It is based upon widely available information that can be utilized to understand the relative priority of chemicals for further evaluation from a risk perspective, i.e., integrating both hazard and exposure elements. Implementation of the screening framework will be most effective when utilizing the best available information. When conducting screening for thousands of chemicals, EPA may not have access to all available information. An open and iterative process that includes an opportunity for review and comment on initial rankings, together with the information that led to the result, and an opportunity to update the ranking with improved information will create a transparent and scientifically sound process. V. References Arnot, J.A., D. Mackay, T. F. Parkerton, R. T. Zaleski, C.S. Warren (2010), Multimedia modeling of human exposure to chemical substances: The roles of food web biomagnification and biotransformation, Environmental Toxicology and Chemistry 29(1):45-55. Boethling, R., K. Fenner, P. Howard, G. Klecka, T. Madsen, J.R. Snape, M.J. Whelan (2009). Environmental persistence of organic pollutants: guidance for development and review of POP risk profiles. Integrated Environmental Assessment and Management 5(4): 539 - 556. Gobas, F.A.P.C, W. de Wolf, L. P Burkhard, E. Verbruggen, K. Plotzke (2009). Revisiting Bioaccumulation Criteria for POPs and PBT Assessments Integrated Environmental Assessment and Management, 5(4):624-637. MacLeod, M., T. E. McKone (2004). Multimedia persistence as an indicator of potential for population-level intake of environmental contaminants, Environmental Toxicology and Chemistry 23(10):2465-2472. van Wijk,D., R. Chénier, T. Henry, M. D Hernando, C. Schulte (2009). Integrated Approach to PBT and POP Prioritization and Risk Assessment' Integrated Environmental Assessment and Management, 5(4):697-711. August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 Proposed Prioritization Approach DRAFT May & 2011 Exposure Elements nat commental consumer 20 2 3 a 33 3 not 8 or Persuntence S not 3 mai 35 a & not 3 Pas $ 3 S the iss = the Tormages RUN $ 3 3 SUM - P8 - Tavamage ranow 3 -13 Expesure Ramking $5 Based os Sum (UN# + pa * Townage PRIORITY GROUPING - Hazard * Expasure Ramkings - 1-8 3-10 11-13 mad Jow Hazard - Highter and Human $ 3 3 & $ Human Mazard Not on Dase 3 low mai * anou % 1000 numour 3 1.8 (duet Nume " 3 & 3 8 Not 100 Acure mi os : 3 A 2000 and not data) 280 v 1000 (pas 1.0 8.0 nomour 8.3 miss Nome 3 & % x CMR Cat 2, on Dawe Call 3: 10 - 3 is # 200 50 ase Igas 0.3 1.0 0.0% - 0.2 mis forme * # $ y GMS CMR Can on OHS Clowe Clat % Repeat Close 10 § on 8 on insurticient 20 information to - - - 0.3 wis 0,00 mist on information to $ 3 a $ August 29, 2011 Source: :https://www.industrydocuments.ucsf.edu/docs/jzbn0226 Hazard and Exposure Criteria for Prioritization Approach HAZARD EXPOSURE Environment and Human Health Classifications based upon GHS Use Elements - based upon IUR Intermediate consumed during industrial processing Envirommental: industrial (not intermediate) - used in an industrial setting From GHS classification guidance document: commercial occupational use in nonindustrial setting Table 4.1.2: scheme for substances hazardous so the aquatic environment. consumer general population residential use Clacufication Persistence: Loag-term Votalile substance (VPS 1000 Pax: Not Persistent if air half life <2 days a (Nate 2) Nonvolatile (VP < 1000 Pa): Not Persistent if: Adequate dass Adequnte voriciny dasa aux a) ready biodegradability (OBCD 301) Rapidly 3 b) inherent biodegradability (OBCD 301, 302, 306) degredable 0) read across from measured data on a related substance. 28 (Note. 3) d) equivalent degree of degradation (i.e. >20% in 28 days) via an abjotic Arute 3 Categorys Chronic 1 Categury: 1 Categasy: I degradation mechanism such as photolysis (OBCD 316) or hydrolysis (OBCD NOEC ar ECA 0.1 NOE - EC cass L 1.00 md of maid 111) and/ar BCF a 200 OR, a substance is Not Persistent if: if e) evaluation of simulation data from transformation in soil, marine water/sediment, Caregusy: Acore 2 Category: Chronic 2 Caregury: Chrumin 2 Caregusy: Chruaic 2 brackish water/sediment, surface water/sediment, oceanic water die away (e.g., OECD 3.00 s: s 10.9 0.1 - NOEC er EC. 13 0.00 <: NOEC - EC, 502 3.00 L(EXC) 10.8 and of andies 308/309) have half lives below 180 days. BCF = 500 as if K. 2 4 OR, if data are lacking: Caregusy: Arnie 3 Caregury: 3 Chrinia 3 f) evaluation via BIOWIN model (EPIWEB 4) 01 EC. : 30,00 1- 100 and fack of Bioaccomulation: stapoid andier BOF: Re 300 if absent log x 3 4 A substance is not bioaccumulative if: 4 4) a) measured TMF < 1 (field study) 3) b) measured fish BMF <1 (lab study) Ne tericity and lack of and BCF 2 500 ase, lag E 4, c) measured fish BCF < 5000 (lab study) MOECA 1 mal d) predicted BCP< 5000 using the BCFBAF model included in EPIWIN 4 The above order reflects the preference for use in decision- making NOTE -- P&B CRITERIA ARB FOR ORGANICS Tonnage - based upon JUR reporting ranges <. 25,000 lbs (below IUR site reporting limit) Human Health: 25.000 - <1 MM lbs national aggregate As above, based upon GHS 1MM - <100 MM lbs national aggregate >100 MM lbs national aggregate August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 Risk-Based Prioritization Matrix Ancreasing Exposure Two-Step towest Prionies Prioritization Process Incregaling Second Tier Rank Ordering within Priority Groups Biomonitoring / Environmental Monitoring Use in Children's Products Emissions (e.g. TRI) International Risk Management Actions Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226

What is STEP 1 in the diagram?

kzbn0226

kzbn0226_p4, kzbn0226_p5, kzbn0226_p6

Scope/Screening, SCOPE/SCREENING

D. EPA Should Not Require Submission of "All" Prior Risk Assessments by Manufacturers as a Precondition to Accepting a Manufacturer Request 39 E. EPA Should Limit Public Comments Accepted on a Manufacturer Request to the Expected Scope of the Risk Evaluation. 40 F. EPA Should Remove the Certification Requirement for Manufacturer- Requested Risk Evaluations 40 IX. Information Collection Request (ICR) Burden Estimates 41 Source: https://www.industrydocuments.ucsf.edu/docs/kzbn0226 EXECUTIVE SUMMARY Under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (LCSA), EPA must complete risk evaluations under statutory deadlines and using robust scientific standards. To achieve this goal, EPA must be flexible in its scoping of risk evaluations so it can maintain both pace and quality, and to inform the regulatory decision-making process in the most meaningful way. EPA should conduct its scoping to include conditions of use that are relevant and meaningful to a fit-for-purpose risk evaluation, and well-tailored to the problems and decisions at hand. EPA must incorporate Section 26 science standards throughout the risk evaluation process. ACC recommends that EPA apply a tiered approach throughout the risk evaluation process. This approach will allow EPA to identify and consider the most relevant and highest risk conditions of use in an efficient and practical manner. The figure below depicts ACC's suggested approach, which is discussed in further detail in Section VI of these comments. in 10 Workplan High-Quality Refined Risk Evaluation High Priority Chemicals & DRAFT Chemicals Manufactures Risk Evaluation Requestes ASSESSMENTI ASSESEMENT Evaluation incorporating Sections is and 26 of the Lautenberg Chemical Safety Act (LOSAL Scope/Screening Level Risk Evaluation Scientific Standards FINAL Susceprible Weight of Scientific Exidence Evaluations Risk Evaluation Exposures Macards Pooulations CONDITI Certain Conditions of Use Present Do not present an unreasonable risk an unreasonable risk Refined No further risk evaluation risk evaluation needed RULEMAKING No further action, PROCESS COMPLETE - These comments offer overarching comments, specific comments responding to EPA's questions set out in the preamble, and additional specific recommendations for the conduct of risk evaluations under the amended statute. Key observations are: EPA must flexibly scope risk evaluations to focus on the most relevant, greatest potential for risk conditions of use. 1/Page Source: https://www.industrydocuments.ucsf.edu/docs/kzbn0226 EPA should apply a tiered approach throughout risk evaluation, including when identifying and considering relevant conditions of use. It is essential that Section 26 science standards are applied to science-based decisions throughout the entire risk evaluation process. These requirements are so central to the function of LSCA risk evaluations that they must be described fully and defined in the regulation so they are applied consistently and stakeholders have adequate notice to participate in the development of the risk evaluations. EPA must revise criteria for manufacturer-requested evaluations to align them procedurally with EPA-initiated ones to incentivize their use as contemplated by statute and to make information and certification requests reasonable. The rule must ensure that peer reviews strive to provide consensus reports. EPA must articulate, with specificity, the scientific approaches and methods it will use in the risk evaluation, rather than simply pointing to Agency guidance which is often outdated, inconsistently interpreted, and inconsistently applied. EPA must describe procedures to ensure robust interagency collaborations that include all knowledgeable and potentially affected agencies, and timelines for public comment must be sufficiently robust to allow for a thorough review of EPA analyses. 2/Page Source: https://www.industrydocuments.ucsf.edu/docs/kzbn0226

what does CMP stands for?

jzbn0226

jzbn0226_p28, jzbn0226_p29, jzbn0226_p30, jzbn0226_p31, jzbn0226_p32, jzbn0226_p33, jzbn0226_p34, jzbn0226_p35, jzbn0226_p36, jzbn0226_p37, jzbn0226_p38, jzbn0226_p39

chemical management program

endpoints, criteria are similarly available for both acute and chronic classification. The use of one common system allows for appropriate assessment of all substances. GHS classification information is readily available for all substances, as U.S. manufacturers have developed GHS classifications for their products to meet international requirements. ACC's support of the GHS criteria for purposes of this prioritization tool is not a categorical endorsement of the GHS criteria for any other purpose. ACC has been an active participant in the development of GHS and supports the system in principle. The GHS has not been broadly implemented to date in the U.S., although the Occupational Safety and Health Administration (OSHA) has indicated an intent to publish a regulation applying GHS in the workplace. ACC's December 29, 2009, comments on OSHA's proposed rule to modify the existing Hazard Communication Standard (HCS) to reflect the GHS urged that implementation of the GHS adhere to certain principles (e.g., continued application of the "Building Block Approach" of the Purple Book). ACC made specific recommendations concerning details of the Hazard Classification definitions, cut-off values, among others. ACC stands behind those comments. In ACC's view, the use of GHS criteria in a screening-level prioritization of chemicals can materially assist in determining which chemicals receive additional evaluation by the Environmental Protection Agency, but does not necessarily preclude the use of other appropriate, applicable criteria developed under other systems. To classify a chemical in a hazard based priority ranking where there is not direct data on the chemical, EPA can employ the full range of approaches, such as QSAR, SAR, read- across and other modeling tools in which EPA has confidence based on molecular structure. In those situations where there still remains insufficient information on either environmental or human health hazards, the chemical would be classified as "high" for its environmental or health ranking. 1. Environmental Ranking Table 1 provides a summary of how GHS criteria could be logically used for chemical management prioritization. Table 1. Environmental Safety - Hazard Ranking GHS Classification - Ranking Environmental Rank Environmental Score Acute I or Chronic I or Insufficient Information to High 4 Classify Acute II or Chronic II Medium High 3 Acute III or Chronic III/IV or Medium 2 none Not classified Low 1 August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 2. Human Health Ranking Table 2. Human Health - Hazard Ranking Health Rank GHS Classification - Human Health Ranking Score GHS CMR Cat 1a, 1b; OR Repeat Dose </= 10 mg/kg/day (oral); </= 20 mg/kg/day (dermal); </= 50 ppm/6hr/day (gas inhalation); High 4 <<= 0.2 mg/1/6h/day (vapour inhalation); </= 0.02 mg/l/6h/day (dust mist fume inhal). OR insufficient information to classify GHS CMR Cat 2; OR Repeat Dose 10 - 100 mg/kg/day (oral); 20 - 200 mg/kg/day (dermal); Medium High 50 - 250 ppm/6hr/day (gas inhalation); 3 0.2 - 1.0 mg/l/6h/day (vapour inhalation); 0.02 - 0.2 mg/l/6h/day (dust mist fume inhal). Not carcinogen/mutagen/repro/develop;OR Repeat Dose 100 - 1000 mg/kg/day (oral); 200 - 2000 mg/kg/day (dermal); Medium 250 - 1000 ppm/6hr/day (gas inhalation); 2 1.0 - 5.0 mg/l/6h/day (vapour inhalation); 0.2 - 1.0 mg/l/6h/day (dust mist fume inhal). Not carcinogen/mutagen/repro/develop; OR Repeat Dose >1000 mg/kg/day (oral); > 2000 mg/kg/day (dermal); Low > 1000 ppm/6hr/day (gas inhalation); 1 >5.0 mg/l/6h/day (vapour inhalation); > 1.0 mg/l/6h/day (dust mist fume inhal). It is important to note that specific concerns about children's health (specifically potential hazards and adverse effects on the nervous system) and those caused by endocrine disruption mechanisms are addressed in this prioritization process: The GHS CMR "R" classification includes specific evaluation of effects on development in utero and upon growth, maturation and reproduction. ("R" stands for reproductive toxicity and includes adverse effects on sexual function and fertility, as well as developmental toxicity in offspring). Endocrine activity is not a distinct toxicological hazard per se, but rather a measure of a compound's ability to interact with components of the endocrine system. The prioritization process evaluates data and information on relevant apical tests, including tests for reproduction and developmental toxicity (potential endocrine pathways). Thus, even if specific August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 screening for potential endocrine activity has not yet been conducted on certain compounds, hazard identification based on observable outcomes from apical toxicity tests (e.g., outcomes such as pathologic states indicative of disease conditions) covers all modes of action, including endocrine pathways. The toxicity information evaluated (CMR and repeat dose toxicity) is directly relevant to evaluating potential hazards to all individuals, including children. Such data typically includes: 1) identification and definition of possible hazards upon all major organ systems from both acute and repeated exposures, including the nervous system; 2) detection of potential hazards arising from in utero exposures, including possible effects on the nervous system; 3) evaluation of potential of a substance to affect reproduction; and 4) evaluation of the potential of a substance to damage DNA. Integration of Hazard Elements: Each of the environmental and human health classifications is assigned a numeric value based upon its ranking, with 1 being the lowest value and 4 the highest. The greatest ranking (highest hazard potential score) of either Environmental or Human Health is used in a substance- specific priority ranking. The numeric value does not imply relative weighting, but rather a numerical order of priority. B. Exposure Potential Ranking The screening method allows for an initial indication of the extent of exposure potential by considering: 1. The chemical's uses and use pattern(s) 2. Production volume as a first pass indicator of relative emission/release potential since magnitude and route (i.e. air, water, soil) of emissions is not available for all substances. 3. Persistence and bioaccumulation characteristics of the substance. Together the 3 elements are used to rank exposure potential. 1. Use Patterns The proposed approach applies the most current 2006 TSCA Inventory Update Reporting rule (IUR, now called the Chemical Data Reporting rule (CDR) data. To keep the initial prioritization simple and transparent, the approach "bins" different use patterns to align with general exposure potential - intermediates, industrial use, commercial use and consumer use. These patterns are the same as those reported in the IUR and are consistent with REACH exposure categories (intermediates, worker, professional, consumer). Chemicals with consumer product use are likely to have widespread potential for general population exposures and are given high priority ranking within the approach. For the initial prioritization approach, child specific products are captured under general consumer products and all consumer products are weighted equally (see additional discussion below under Second Tier Considerations). Intermediates will have low general population exposures, since these substances are consumed, by definition, within the workplace. Therefore, they are given the lowest priority ranking within the approach. In the context of the proposed approach, the intermediates category includes both intermediates and non-isolated intermediates. A chemical used in multiple use patterns is August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 assigned the priority of the highest use, e.g., a chemical in both industrial and commercial uses would be assigned the commercial Medium-High rank. Table 3. Use Patterns - Exposure Ranking Use Pattern Ranking Use Pattern Score Consumer High 4 Commercial Medium-High 3 Industrial Medium 2 Intermediates Low 1 The IUR Definitions of these terms are (40 CFR 710.3, 710.43): "consumer use" means the use of a chemical substance or a mixture containing a chemical substance (including as part of article) when sold to or made available to consumers for their use. "commercial use" means the use of a chemical substance or a mixture containing a chemical substance (including as part of an article) in a commercial enterprise providing saleable goods or services. "industrial use" means use at a site at which one or more chemical substances or mixtures are manufactured (including imported). "intermediate" means any chemical substance: which is intentionally removed from the equipment in which it is manufactured, and which either is consumed in whole or in part in chemical reaction(s) used for the intentional manufacture of other chemical substance(s) or mixture(s), or is intentionally present for the purpose of altering the rate of such chemical reaction(s) "non-isolated intermediate" means any intermediate that is not intentionally removed from the equipment in which is it manufactured, including the reaction vessel in which it is manufactured, equipment which is ancillary to the reaction vessel, and any equipment through which the substance passes during a continuous flow process, but not including tanks or other vessels in which the substance is stored after its manufacture. 2. Production Volume Recognizing that detailed exposure information will not be available for all substances to be screened, the proposed approach uses production volume as an indicator of exposure, which is widely used in many prioritization schemes. As production volume is just a rough surrogate of emissions, ACC suggests only very broad categories, covering about two orders of magnitude each. It may be useful to consider how additional exposure estimates may be applied in the second tier assessment. Table 4. Production Volume as Emission Surrogate - Exposure Ranking Production Volume as Emission Surrogate Ranking Volume Score >= 100,000,000 lbs national aggregate High 4 1,000,000 lbs to < 100,000,000 lbs national Medium - High 3 aggregate August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 >= 25,000 lbs to < 1,000,000 lbs national Medium 2 aggregate < 25,000 lbs (below IUR site reporting limit) Low 1 3. Persistence and Bioaccumulation Persistence and bioaccumulation are viewed as indicators of exposure, and therefore are considered under the exposure axis of the approach. A persistent substance that is emitted to the environment at the same rate as a non-persistent substance with similar partitioning properties will result in higher exposure to humans and the environment. In fact, multimedia modeling clearly indicates that environmental persistence in the compartment to which a substance partitions is a good indicator of human exposure potential (MacLeod & McKone et al. 2004). Similarly, substances that are not subject to biotransformation by higher organisms will exhibit a high bioaccumulation potential that results in higher exposures via the food chain (Arnot et al. 2010). Therefore, it is recommended to apply the proposed persistence and bioaccumulation criteria in assessment of exposure potential as described below. The persistent and bioaccumulative (P&B) criteria of the proposed approach are targeted toward organic chemicals. Separate assessment criteria are likely needed for P&B evaluation for inorganics/metals, as in the approach taken by Canada's Chemical Management Program (CMP). For assessing persistence, based upon recent expert consensus (Boethling et al., 2009) it is recommended to distinguish persistent from non-persistent chemicals using the following criteria: Volatile chemicals can be defined using a vapor pressure cut-off (i.e., > 1000 Pa) For volatile chemicals, persistent versus non-persistent chemicals are differentiated using a half-life cut-off in air (e.g., a substance is not persistent if air half life is < 2 days). For non-volatile chemicals, non-persistent substances can be defined as substances that are deemed: readily or inherently biodegradable using standard biodegradation tests (OECD 301, 302, 306 test guidelines) or SAR or read across from measured data on a related substance, show an equivalent degree of degradation (i.e. >20% in 28 days) via an abiotic degradation mechanism such as photolysis (OECD 316) or hydrolysi (OECD 111), evaluation of simulation data from transformation in soil, marine water/sediment, brackish water/sediment, surface water/sediment, oceanic water die away (e.g. OECD 308/309) have half lives below 180 days, OR if data are lacking, evaluation via BIOWIN model (EPIWEB 4) Non-volatile substances that are not biodegradable or subject to abiotic losses based on the above criteria would be considered persistent. For assessing bioaccumulation, the key question for screening is the potential for biomagnification based on recent expert consensus (Gobas et al. 2009). To determine if a substance has the potential to biomagnify the following metrics have been agreed: Trophic Magnification Factor (TMF)>1, fish Biomagnification Factor (BMF)>1 fish Bioaccumulation Factor (BAF)/Bioconcentration Factor (BCF) > 5000. These metrics can be August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 derived using lab or field measurements (where available) or recently improved computational models that are included in EPA's EPIWEB model that can be freely downloaded at www.epa.gov/oppt/exposure/pubs/episuite.htm. This approach allows all organics to be addressed and is a scientifically updated version of the approach used in Canada's CMP. Based on the above recommendations, substances can be grouped with regard to persistence and bioaccumulation as follows: Table 5. Persistence and Bioaccumulation - Exposure Ranking Persistence and P&B Ranking P&B Score Bioaccumulation Persistent and High 5 Bioaccumulative Persistent and Not Medium 3 Bioaccumulative OR Not Persistent and Bioaccumulative Not Persistent and Not Low 1 Bioaccumulative Integration of Exposure Elements: As demonstrated in the tables, each factor (use pattern, P&B, and production volume) would be assigned a numeric score based upon its ranking. All 3 factors are added to arrive at an overall value. These values are then separated into categories from low to high exposure potential. A proposed "banding" approach is illustrated in Table 6. Table 6. Integration of Exposure Rankings Combined Score - All 3 Exposure Rank Exposure Ranking elements Score 11 13 High 5 9 10 Medium High 4 7 8 Medium 3 5 6 Medium Low 2 3 4 Low 1 Overall Priority Grouping: In the overall approach, both hazard and exposure elements are considered when placing a substance in a risk-based prioritization ranking. The overall prioritization score for priority grouping and risk evaluation is based on the combined consideration of the hazard and exposure rankings. Priority Groups 7, 8, and 9 are deemed High Priority; Priority Groups 4, 5, and 6 are Medium Priority; and Priority Groups 2 and 3 are Low Priority. August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 Review and Comment: It is important that screening be done in an open and transparent way and that the best available information be used. When screening for thousands of chemicals, EPA may not have access to all available information. The process should provide an opportunity for review and comment on initial rankings and an opportunity to submit additional relevant data and information to update proposed rankings with improved information. III. Second Tier Considerations: After the initial screening, some substances within individual priority groupings may require further rank ordering, particularly where a large number of chemicals are in the same priority group. Listed below are the types of information that will be useful to consider in this Second Tier rank ordering: Biomonitoring/Environmental Monitoring Data: Mere detection of chemicals in humans or the environment, i.e., "found in biomonitoring (CDC), found in water (NCOD), and found in air", while providing an indication of exposure, does not provide a useful criterion for exposure potential because almost any industrial or commercial chemical could be detected at trace levels, given increasingly sensitive analytical methods. Therefore, detection alone primarily reflects only the fact that a specific chemical was included in a measurement program. This criterion will also tend to bias the prioritization of chemicals for which well-established analytical methods are available. Consequently, this criterion is not used in the initial prioritization scheme. However, within a particular priority grouping, reliable monitoring information should be considered for Second Tier rank ordering within a quantitative process that assesses if the data is above a level of concern (i.e., places it in a risk context). Use in Children's Products: Protection of childrens' health is a top priority and, in the initial ranking, child-specific products are captured under general consumer products and all consumer products are weighted equally. The specific IUR reporting of information on chemical use in products intended for children would be considered further within a particular priority grouping for Second Tier rank ordering, noting the following points: the IUR definition is based upon use in a child specific product rather than child specific exposure potential¹ (see below). Without knowing a specific product type, it is difficult to understand if 1 IUR definition (Federal Register Volume 75, Number 156, Friday August 30, 2010, p. 49686): Intended for use by children means the chemical substance or mixture is used in or on a product that is specifically intended for use by children age 14 or younger. A chemical substance or mixture is intended for use by children when the submitter answers "yes" to at least on of the following questions for the product into which the submitter's chemical substance or mixture is incorporated: (1) Is the product commonly recognized (i.e., by a reasonable person) as being intended for children age 14 or younger? (2) Does the manufacturer of the product state through product labeling or other written materials that the product is intended for or will be used by children age 14 or younger? (3) Is the advertising, promotion, or marketing of the product aimed at children age 14 or younger? August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 potential child exposure is greater than for a non-child specific product. For example, how does child exposure to a general use cleaner compare to exposure from use in a child's raincoat. In the VCCEP assessments, there are examples for inhalation exposures where estimates of passive child exposure during adult product use exceeded conservative estimates of child exposure during active use of a child-specific product (such as a hobby product) - differences were related to the amount of product used and substance concentration within the product (MEK VCCEP Submission). the IUR definition targets children age 14 and younger. Younger children may be exposed to a variety of non-child specific products that are in general household use. Older children may be exposed to a variety of additional products. the IUR information request is targeted to manufacturers, which may not have direct knowledge of all uses, particularly the presence in products for specific subpopulations, such as children. Therefore, it is not clear that the information requested for the IUR information would be consistently available across all substances being screened. Ideally, this information should be requested from formulators of child-specific products. Therefore, for the initial prioritization approach, which represents a broad, unrefined categorization, child specific products are captured under general consumer products and all consumer products are weighted equally. The IUR information on child specific use would be utilized within a particular priority grouping for Second Tier rank ordering. If the IUR information is utilized, it is important that the limitations above be considered in its application. Emissions Data: Production volume, which is readily available for substances, is used in this proposed approach, but only serves as a surrogate for environmental emissions. For further prioritization, data or estimates of environmental emissions can be used to refine prioritization. Estimates of environmental emissions will be available for some substances (e.g., TRI data). When TRI data are utilized it should be recognized that it addresses only emissions that result from industrial and not wide dispersive uses. In other cases, emissions estimates can be developed as a percentage of production volume based upon consideration of use categories. Within a particular priority grouping, available emissions information can be considered for Second Tier rank ordering, with the understanding that emissions information is not an indicator of actual exposure. Similarly, non-isolated system intermediates, by definition, would have de minimis exposure potential. Therefore, this IUR information could be considered within a particular priority grouping for Second Tier rank ordering. International Risk Management Actions: An initial screening approach for chemical prioritization should be based upon consistent application of specific hazard and exposure science elements that define risk potential. The hazard and exposure elements should be applicable across all substances being evaluated. For initial screening, existence of international risk management action plans should not be a factor that determines priority grouping. Risk management plans may be based upon many factors, including political drivers. It is unclear how factors, their relative weighting, and the rigor of the evaluation may vary across agencies and substances. For initial screening August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 purposes, the same science-based criteria should be used to rank all substances. Consideration of existing international risk management plans could be utilized to check the functioning of the approach and could be considered within a particular priority grouping for Second Tier rank ordering with the possible effect of moving a chemical up in a grouping if actions are being taken internationally. IV. Summary ACC's prioritization approach is an example of a risk-based screening prioritization process that implements the general principles outlined at the outset of this document. It is based upon widely available information that can be utilized to understand the relative priority of chemicals for further evaluation from a risk perspective, i.e., integrating both hazard and exposure elements. Implementation of the screening framework will be most effective when utilizing the best available information. When conducting screening for thousands of chemicals, EPA may not have access to all available information. An open and iterative process that includes an opportunity for review and comment on initial rankings, together with the information that led to the result, and an opportunity to update the ranking with improved information will create a transparent and scientifically sound process. V. References Arnot, J.A., D. Mackay, T. F. Parkerton, R. T. Zaleski, C.S. Warren (2010), Multimedia modeling of human exposure to chemical substances: The roles of food web biomagnification and biotransformation, Environmental Toxicology and Chemistry 29(1):45-55. Boethling, R., K. Fenner, P. Howard, G. Klecka, T. Madsen, J.R. Snape, M.J. Whelan (2009). Environmental persistence of organic pollutants: guidance for development and review of POP risk profiles. Integrated Environmental Assessment and Management 5(4): 539 - 556. Gobas, F.A.P.C, W. de Wolf, L. P Burkhard, E. Verbruggen, K. Plotzke (2009). Revisiting Bioaccumulation Criteria for POPs and PBT Assessments Integrated Environmental Assessment and Management, 5(4):624-637. MacLeod, M., T. E. McKone (2004). Multimedia persistence as an indicator of potential for population-level intake of environmental contaminants, Environmental Toxicology and Chemistry 23(10):2465-2472. van Wijk,D., R. Chénier, T. Henry, M. D Hernando, C. Schulte (2009). Integrated Approach to PBT and POP Prioritization and Risk Assessment' Integrated Environmental Assessment and Management, 5(4):697-711. August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 Proposed Prioritization Approach DRAFT May & 2011 Exposure Elements nat commental consumer 20 2 3 a 33 3 not 8 or Persuntence S not 3 mai 35 a & not 3 Pas $ 3 S the iss = the Tormages RUN $ 3 3 SUM - P8 - Tavamage ranow 3 -13 Expesure Ramking $5 Based os Sum (UN# + pa * Townage PRIORITY GROUPING - Hazard * Expasure Ramkings - 1-8 3-10 11-13 mad Jow Hazard - Highter and Human $ 3 3 & $ Human Mazard Not on Dase 3 low mai * anou % 1000 numour 3 1.8 (duet Nume " 3 & 3 8 Not 100 Acure mi os : 3 A 2000 and not data) 280 v 1000 (pas 1.0 8.0 nomour 8.3 miss Nome 3 & % x CMR Cat 2, on Dawe Call 3: 10 - 3 is # 200 50 ase Igas 0.3 1.0 0.0% - 0.2 mis forme * # $ y GMS CMR Can on OHS Clowe Clat % Repeat Close 10 § on 8 on insurticient 20 information to - - - 0.3 wis 0,00 mist on information to $ 3 a $ August 29, 2011 Source: :https://www.industrydocuments.ucsf.edu/docs/jzbn0226 Hazard and Exposure Criteria for Prioritization Approach HAZARD EXPOSURE Environment and Human Health Classifications based upon GHS Use Elements - based upon IUR Intermediate consumed during industrial processing Envirommental: industrial (not intermediate) - used in an industrial setting From GHS classification guidance document: commercial occupational use in nonindustrial setting Table 4.1.2: scheme for substances hazardous so the aquatic environment. consumer general population residential use Clacufication Persistence: Loag-term Votalile substance (VPS 1000 Pax: Not Persistent if air half life <2 days a (Nate 2) Nonvolatile (VP < 1000 Pa): Not Persistent if: Adequate dass Adequnte voriciny dasa aux a) ready biodegradability (OBCD 301) Rapidly 3 b) inherent biodegradability (OBCD 301, 302, 306) degredable 0) read across from measured data on a related substance. 28 (Note. 3) d) equivalent degree of degradation (i.e. >20% in 28 days) via an abjotic Arute 3 Categorys Chronic 1 Categury: 1 Categasy: I degradation mechanism such as photolysis (OBCD 316) or hydrolysis (OBCD NOEC ar ECA 0.1 NOE - EC cass L 1.00 md of maid 111) and/ar BCF a 200 OR, a substance is Not Persistent if: if e) evaluation of simulation data from transformation in soil, marine water/sediment, Caregusy: Acore 2 Category: Chronic 2 Caregury: Chrumin 2 Caregusy: Chruaic 2 brackish water/sediment, surface water/sediment, oceanic water die away (e.g., OECD 3.00 s: s 10.9 0.1 - NOEC er EC. 13 0.00 <: NOEC - EC, 502 3.00 L(EXC) 10.8 and of andies 308/309) have half lives below 180 days. BCF = 500 as if K. 2 4 OR, if data are lacking: Caregusy: Arnie 3 Caregury: 3 Chrinia 3 f) evaluation via BIOWIN model (EPIWEB 4) 01 EC. : 30,00 1- 100 and fack of Bioaccomulation: stapoid andier BOF: Re 300 if absent log x 3 4 A substance is not bioaccumulative if: 4 4) a) measured TMF < 1 (field study) 3) b) measured fish BMF <1 (lab study) Ne tericity and lack of and BCF 2 500 ase, lag E 4, c) measured fish BCF < 5000 (lab study) MOECA 1 mal d) predicted BCP< 5000 using the BCFBAF model included in EPIWIN 4 The above order reflects the preference for use in decision- making NOTE -- P&B CRITERIA ARB FOR ORGANICS Tonnage - based upon JUR reporting ranges <. 25,000 lbs (below IUR site reporting limit) Human Health: 25.000 - <1 MM lbs national aggregate As above, based upon GHS 1MM - <100 MM lbs national aggregate >100 MM lbs national aggregate August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 Risk-Based Prioritization Matrix Ancreasing Exposure Two-Step towest Prionies Prioritization Process Incregaling Second Tier Rank Ordering within Priority Groups Biomonitoring / Environmental Monitoring Use in Children's Products Emissions (e.g. TRI) International Risk Management Actions Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226

What is the full form of TSCA?

kzbn0226

kzbn0226_p4, kzbn0226_p5, kzbn0226_p6

Toxic Substances Control Act

D. EPA Should Not Require Submission of "All" Prior Risk Assessments by Manufacturers as a Precondition to Accepting a Manufacturer Request 39 E. EPA Should Limit Public Comments Accepted on a Manufacturer Request to the Expected Scope of the Risk Evaluation. 40 F. EPA Should Remove the Certification Requirement for Manufacturer- Requested Risk Evaluations 40 IX. Information Collection Request (ICR) Burden Estimates 41 Source: https://www.industrydocuments.ucsf.edu/docs/kzbn0226 EXECUTIVE SUMMARY Under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (LCSA), EPA must complete risk evaluations under statutory deadlines and using robust scientific standards. To achieve this goal, EPA must be flexible in its scoping of risk evaluations so it can maintain both pace and quality, and to inform the regulatory decision-making process in the most meaningful way. EPA should conduct its scoping to include conditions of use that are relevant and meaningful to a fit-for-purpose risk evaluation, and well-tailored to the problems and decisions at hand. EPA must incorporate Section 26 science standards throughout the risk evaluation process. ACC recommends that EPA apply a tiered approach throughout the risk evaluation process. This approach will allow EPA to identify and consider the most relevant and highest risk conditions of use in an efficient and practical manner. The figure below depicts ACC's suggested approach, which is discussed in further detail in Section VI of these comments. in 10 Workplan High-Quality Refined Risk Evaluation High Priority Chemicals & DRAFT Chemicals Manufactures Risk Evaluation Requestes ASSESSMENTI ASSESEMENT Evaluation incorporating Sections is and 26 of the Lautenberg Chemical Safety Act (LOSAL Scope/Screening Level Risk Evaluation Scientific Standards FINAL Susceprible Weight of Scientific Exidence Evaluations Risk Evaluation Exposures Macards Pooulations CONDITI Certain Conditions of Use Present Do not present an unreasonable risk an unreasonable risk Refined No further risk evaluation risk evaluation needed RULEMAKING No further action, PROCESS COMPLETE - These comments offer overarching comments, specific comments responding to EPA's questions set out in the preamble, and additional specific recommendations for the conduct of risk evaluations under the amended statute. Key observations are: EPA must flexibly scope risk evaluations to focus on the most relevant, greatest potential for risk conditions of use. 1/Page Source: https://www.industrydocuments.ucsf.edu/docs/kzbn0226 EPA should apply a tiered approach throughout risk evaluation, including when identifying and considering relevant conditions of use. It is essential that Section 26 science standards are applied to science-based decisions throughout the entire risk evaluation process. These requirements are so central to the function of LSCA risk evaluations that they must be described fully and defined in the regulation so they are applied consistently and stakeholders have adequate notice to participate in the development of the risk evaluations. EPA must revise criteria for manufacturer-requested evaluations to align them procedurally with EPA-initiated ones to incentivize their use as contemplated by statute and to make information and certification requests reasonable. The rule must ensure that peer reviews strive to provide consensus reports. EPA must articulate, with specificity, the scientific approaches and methods it will use in the risk evaluation, rather than simply pointing to Agency guidance which is often outdated, inconsistently interpreted, and inconsistently applied. EPA must describe procedures to ensure robust interagency collaborations that include all knowledgeable and potentially affected agencies, and timelines for public comment must be sufficiently robust to allow for a thorough review of EPA analyses. 2/Page Source: https://www.industrydocuments.ucsf.edu/docs/kzbn0226

P&B criteria of the proposed approach are targeted towards?

jzbn0226

jzbn0226_p28, jzbn0226_p29, jzbn0226_p30, jzbn0226_p31, jzbn0226_p32, jzbn0226_p33, jzbn0226_p34, jzbn0226_p35, jzbn0226_p36, jzbn0226_p37, jzbn0226_p38, jzbn0226_p39

organic chemicals

endpoints, criteria are similarly available for both acute and chronic classification. The use of one common system allows for appropriate assessment of all substances. GHS classification information is readily available for all substances, as U.S. manufacturers have developed GHS classifications for their products to meet international requirements. ACC's support of the GHS criteria for purposes of this prioritization tool is not a categorical endorsement of the GHS criteria for any other purpose. ACC has been an active participant in the development of GHS and supports the system in principle. The GHS has not been broadly implemented to date in the U.S., although the Occupational Safety and Health Administration (OSHA) has indicated an intent to publish a regulation applying GHS in the workplace. ACC's December 29, 2009, comments on OSHA's proposed rule to modify the existing Hazard Communication Standard (HCS) to reflect the GHS urged that implementation of the GHS adhere to certain principles (e.g., continued application of the "Building Block Approach" of the Purple Book). ACC made specific recommendations concerning details of the Hazard Classification definitions, cut-off values, among others. ACC stands behind those comments. In ACC's view, the use of GHS criteria in a screening-level prioritization of chemicals can materially assist in determining which chemicals receive additional evaluation by the Environmental Protection Agency, but does not necessarily preclude the use of other appropriate, applicable criteria developed under other systems. To classify a chemical in a hazard based priority ranking where there is not direct data on the chemical, EPA can employ the full range of approaches, such as QSAR, SAR, read- across and other modeling tools in which EPA has confidence based on molecular structure. In those situations where there still remains insufficient information on either environmental or human health hazards, the chemical would be classified as "high" for its environmental or health ranking. 1. Environmental Ranking Table 1 provides a summary of how GHS criteria could be logically used for chemical management prioritization. Table 1. Environmental Safety - Hazard Ranking GHS Classification - Ranking Environmental Rank Environmental Score Acute I or Chronic I or Insufficient Information to High 4 Classify Acute II or Chronic II Medium High 3 Acute III or Chronic III/IV or Medium 2 none Not classified Low 1 August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 2. Human Health Ranking Table 2. Human Health - Hazard Ranking Health Rank GHS Classification - Human Health Ranking Score GHS CMR Cat 1a, 1b; OR Repeat Dose </= 10 mg/kg/day (oral); </= 20 mg/kg/day (dermal); </= 50 ppm/6hr/day (gas inhalation); High 4 <<= 0.2 mg/1/6h/day (vapour inhalation); </= 0.02 mg/l/6h/day (dust mist fume inhal). OR insufficient information to classify GHS CMR Cat 2; OR Repeat Dose 10 - 100 mg/kg/day (oral); 20 - 200 mg/kg/day (dermal); Medium High 50 - 250 ppm/6hr/day (gas inhalation); 3 0.2 - 1.0 mg/l/6h/day (vapour inhalation); 0.02 - 0.2 mg/l/6h/day (dust mist fume inhal). Not carcinogen/mutagen/repro/develop;OR Repeat Dose 100 - 1000 mg/kg/day (oral); 200 - 2000 mg/kg/day (dermal); Medium 250 - 1000 ppm/6hr/day (gas inhalation); 2 1.0 - 5.0 mg/l/6h/day (vapour inhalation); 0.2 - 1.0 mg/l/6h/day (dust mist fume inhal). Not carcinogen/mutagen/repro/develop; OR Repeat Dose >1000 mg/kg/day (oral); > 2000 mg/kg/day (dermal); Low > 1000 ppm/6hr/day (gas inhalation); 1 >5.0 mg/l/6h/day (vapour inhalation); > 1.0 mg/l/6h/day (dust mist fume inhal). It is important to note that specific concerns about children's health (specifically potential hazards and adverse effects on the nervous system) and those caused by endocrine disruption mechanisms are addressed in this prioritization process: The GHS CMR "R" classification includes specific evaluation of effects on development in utero and upon growth, maturation and reproduction. ("R" stands for reproductive toxicity and includes adverse effects on sexual function and fertility, as well as developmental toxicity in offspring). Endocrine activity is not a distinct toxicological hazard per se, but rather a measure of a compound's ability to interact with components of the endocrine system. The prioritization process evaluates data and information on relevant apical tests, including tests for reproduction and developmental toxicity (potential endocrine pathways). Thus, even if specific August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 screening for potential endocrine activity has not yet been conducted on certain compounds, hazard identification based on observable outcomes from apical toxicity tests (e.g., outcomes such as pathologic states indicative of disease conditions) covers all modes of action, including endocrine pathways. The toxicity information evaluated (CMR and repeat dose toxicity) is directly relevant to evaluating potential hazards to all individuals, including children. Such data typically includes: 1) identification and definition of possible hazards upon all major organ systems from both acute and repeated exposures, including the nervous system; 2) detection of potential hazards arising from in utero exposures, including possible effects on the nervous system; 3) evaluation of potential of a substance to affect reproduction; and 4) evaluation of the potential of a substance to damage DNA. Integration of Hazard Elements: Each of the environmental and human health classifications is assigned a numeric value based upon its ranking, with 1 being the lowest value and 4 the highest. The greatest ranking (highest hazard potential score) of either Environmental or Human Health is used in a substance- specific priority ranking. The numeric value does not imply relative weighting, but rather a numerical order of priority. B. Exposure Potential Ranking The screening method allows for an initial indication of the extent of exposure potential by considering: 1. The chemical's uses and use pattern(s) 2. Production volume as a first pass indicator of relative emission/release potential since magnitude and route (i.e. air, water, soil) of emissions is not available for all substances. 3. Persistence and bioaccumulation characteristics of the substance. Together the 3 elements are used to rank exposure potential. 1. Use Patterns The proposed approach applies the most current 2006 TSCA Inventory Update Reporting rule (IUR, now called the Chemical Data Reporting rule (CDR) data. To keep the initial prioritization simple and transparent, the approach "bins" different use patterns to align with general exposure potential - intermediates, industrial use, commercial use and consumer use. These patterns are the same as those reported in the IUR and are consistent with REACH exposure categories (intermediates, worker, professional, consumer). Chemicals with consumer product use are likely to have widespread potential for general population exposures and are given high priority ranking within the approach. For the initial prioritization approach, child specific products are captured under general consumer products and all consumer products are weighted equally (see additional discussion below under Second Tier Considerations). Intermediates will have low general population exposures, since these substances are consumed, by definition, within the workplace. Therefore, they are given the lowest priority ranking within the approach. In the context of the proposed approach, the intermediates category includes both intermediates and non-isolated intermediates. A chemical used in multiple use patterns is August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 assigned the priority of the highest use, e.g., a chemical in both industrial and commercial uses would be assigned the commercial Medium-High rank. Table 3. Use Patterns - Exposure Ranking Use Pattern Ranking Use Pattern Score Consumer High 4 Commercial Medium-High 3 Industrial Medium 2 Intermediates Low 1 The IUR Definitions of these terms are (40 CFR 710.3, 710.43): "consumer use" means the use of a chemical substance or a mixture containing a chemical substance (including as part of article) when sold to or made available to consumers for their use. "commercial use" means the use of a chemical substance or a mixture containing a chemical substance (including as part of an article) in a commercial enterprise providing saleable goods or services. "industrial use" means use at a site at which one or more chemical substances or mixtures are manufactured (including imported). "intermediate" means any chemical substance: which is intentionally removed from the equipment in which it is manufactured, and which either is consumed in whole or in part in chemical reaction(s) used for the intentional manufacture of other chemical substance(s) or mixture(s), or is intentionally present for the purpose of altering the rate of such chemical reaction(s) "non-isolated intermediate" means any intermediate that is not intentionally removed from the equipment in which is it manufactured, including the reaction vessel in which it is manufactured, equipment which is ancillary to the reaction vessel, and any equipment through which the substance passes during a continuous flow process, but not including tanks or other vessels in which the substance is stored after its manufacture. 2. Production Volume Recognizing that detailed exposure information will not be available for all substances to be screened, the proposed approach uses production volume as an indicator of exposure, which is widely used in many prioritization schemes. As production volume is just a rough surrogate of emissions, ACC suggests only very broad categories, covering about two orders of magnitude each. It may be useful to consider how additional exposure estimates may be applied in the second tier assessment. Table 4. Production Volume as Emission Surrogate - Exposure Ranking Production Volume as Emission Surrogate Ranking Volume Score >= 100,000,000 lbs national aggregate High 4 1,000,000 lbs to < 100,000,000 lbs national Medium - High 3 aggregate August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 >= 25,000 lbs to < 1,000,000 lbs national Medium 2 aggregate < 25,000 lbs (below IUR site reporting limit) Low 1 3. Persistence and Bioaccumulation Persistence and bioaccumulation are viewed as indicators of exposure, and therefore are considered under the exposure axis of the approach. A persistent substance that is emitted to the environment at the same rate as a non-persistent substance with similar partitioning properties will result in higher exposure to humans and the environment. In fact, multimedia modeling clearly indicates that environmental persistence in the compartment to which a substance partitions is a good indicator of human exposure potential (MacLeod & McKone et al. 2004). Similarly, substances that are not subject to biotransformation by higher organisms will exhibit a high bioaccumulation potential that results in higher exposures via the food chain (Arnot et al. 2010). Therefore, it is recommended to apply the proposed persistence and bioaccumulation criteria in assessment of exposure potential as described below. The persistent and bioaccumulative (P&B) criteria of the proposed approach are targeted toward organic chemicals. Separate assessment criteria are likely needed for P&B evaluation for inorganics/metals, as in the approach taken by Canada's Chemical Management Program (CMP). For assessing persistence, based upon recent expert consensus (Boethling et al., 2009) it is recommended to distinguish persistent from non-persistent chemicals using the following criteria: Volatile chemicals can be defined using a vapor pressure cut-off (i.e., > 1000 Pa) For volatile chemicals, persistent versus non-persistent chemicals are differentiated using a half-life cut-off in air (e.g., a substance is not persistent if air half life is < 2 days). For non-volatile chemicals, non-persistent substances can be defined as substances that are deemed: readily or inherently biodegradable using standard biodegradation tests (OECD 301, 302, 306 test guidelines) or SAR or read across from measured data on a related substance, show an equivalent degree of degradation (i.e. >20% in 28 days) via an abiotic degradation mechanism such as photolysis (OECD 316) or hydrolysi (OECD 111), evaluation of simulation data from transformation in soil, marine water/sediment, brackish water/sediment, surface water/sediment, oceanic water die away (e.g. OECD 308/309) have half lives below 180 days, OR if data are lacking, evaluation via BIOWIN model (EPIWEB 4) Non-volatile substances that are not biodegradable or subject to abiotic losses based on the above criteria would be considered persistent. For assessing bioaccumulation, the key question for screening is the potential for biomagnification based on recent expert consensus (Gobas et al. 2009). To determine if a substance has the potential to biomagnify the following metrics have been agreed: Trophic Magnification Factor (TMF)>1, fish Biomagnification Factor (BMF)>1 fish Bioaccumulation Factor (BAF)/Bioconcentration Factor (BCF) > 5000. These metrics can be August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 derived using lab or field measurements (where available) or recently improved computational models that are included in EPA's EPIWEB model that can be freely downloaded at www.epa.gov/oppt/exposure/pubs/episuite.htm. This approach allows all organics to be addressed and is a scientifically updated version of the approach used in Canada's CMP. Based on the above recommendations, substances can be grouped with regard to persistence and bioaccumulation as follows: Table 5. Persistence and Bioaccumulation - Exposure Ranking Persistence and P&B Ranking P&B Score Bioaccumulation Persistent and High 5 Bioaccumulative Persistent and Not Medium 3 Bioaccumulative OR Not Persistent and Bioaccumulative Not Persistent and Not Low 1 Bioaccumulative Integration of Exposure Elements: As demonstrated in the tables, each factor (use pattern, P&B, and production volume) would be assigned a numeric score based upon its ranking. All 3 factors are added to arrive at an overall value. These values are then separated into categories from low to high exposure potential. A proposed "banding" approach is illustrated in Table 6. Table 6. Integration of Exposure Rankings Combined Score - All 3 Exposure Rank Exposure Ranking elements Score 11 13 High 5 9 10 Medium High 4 7 8 Medium 3 5 6 Medium Low 2 3 4 Low 1 Overall Priority Grouping: In the overall approach, both hazard and exposure elements are considered when placing a substance in a risk-based prioritization ranking. The overall prioritization score for priority grouping and risk evaluation is based on the combined consideration of the hazard and exposure rankings. Priority Groups 7, 8, and 9 are deemed High Priority; Priority Groups 4, 5, and 6 are Medium Priority; and Priority Groups 2 and 3 are Low Priority. August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 Review and Comment: It is important that screening be done in an open and transparent way and that the best available information be used. When screening for thousands of chemicals, EPA may not have access to all available information. The process should provide an opportunity for review and comment on initial rankings and an opportunity to submit additional relevant data and information to update proposed rankings with improved information. III. Second Tier Considerations: After the initial screening, some substances within individual priority groupings may require further rank ordering, particularly where a large number of chemicals are in the same priority group. Listed below are the types of information that will be useful to consider in this Second Tier rank ordering: Biomonitoring/Environmental Monitoring Data: Mere detection of chemicals in humans or the environment, i.e., "found in biomonitoring (CDC), found in water (NCOD), and found in air", while providing an indication of exposure, does not provide a useful criterion for exposure potential because almost any industrial or commercial chemical could be detected at trace levels, given increasingly sensitive analytical methods. Therefore, detection alone primarily reflects only the fact that a specific chemical was included in a measurement program. This criterion will also tend to bias the prioritization of chemicals for which well-established analytical methods are available. Consequently, this criterion is not used in the initial prioritization scheme. However, within a particular priority grouping, reliable monitoring information should be considered for Second Tier rank ordering within a quantitative process that assesses if the data is above a level of concern (i.e., places it in a risk context). Use in Children's Products: Protection of childrens' health is a top priority and, in the initial ranking, child-specific products are captured under general consumer products and all consumer products are weighted equally. The specific IUR reporting of information on chemical use in products intended for children would be considered further within a particular priority grouping for Second Tier rank ordering, noting the following points: the IUR definition is based upon use in a child specific product rather than child specific exposure potential¹ (see below). Without knowing a specific product type, it is difficult to understand if 1 IUR definition (Federal Register Volume 75, Number 156, Friday August 30, 2010, p. 49686): Intended for use by children means the chemical substance or mixture is used in or on a product that is specifically intended for use by children age 14 or younger. A chemical substance or mixture is intended for use by children when the submitter answers "yes" to at least on of the following questions for the product into which the submitter's chemical substance or mixture is incorporated: (1) Is the product commonly recognized (i.e., by a reasonable person) as being intended for children age 14 or younger? (2) Does the manufacturer of the product state through product labeling or other written materials that the product is intended for or will be used by children age 14 or younger? (3) Is the advertising, promotion, or marketing of the product aimed at children age 14 or younger? August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 potential child exposure is greater than for a non-child specific product. For example, how does child exposure to a general use cleaner compare to exposure from use in a child's raincoat. In the VCCEP assessments, there are examples for inhalation exposures where estimates of passive child exposure during adult product use exceeded conservative estimates of child exposure during active use of a child-specific product (such as a hobby product) - differences were related to the amount of product used and substance concentration within the product (MEK VCCEP Submission). the IUR definition targets children age 14 and younger. Younger children may be exposed to a variety of non-child specific products that are in general household use. Older children may be exposed to a variety of additional products. the IUR information request is targeted to manufacturers, which may not have direct knowledge of all uses, particularly the presence in products for specific subpopulations, such as children. Therefore, it is not clear that the information requested for the IUR information would be consistently available across all substances being screened. Ideally, this information should be requested from formulators of child-specific products. Therefore, for the initial prioritization approach, which represents a broad, unrefined categorization, child specific products are captured under general consumer products and all consumer products are weighted equally. The IUR information on child specific use would be utilized within a particular priority grouping for Second Tier rank ordering. If the IUR information is utilized, it is important that the limitations above be considered in its application. Emissions Data: Production volume, which is readily available for substances, is used in this proposed approach, but only serves as a surrogate for environmental emissions. For further prioritization, data or estimates of environmental emissions can be used to refine prioritization. Estimates of environmental emissions will be available for some substances (e.g., TRI data). When TRI data are utilized it should be recognized that it addresses only emissions that result from industrial and not wide dispersive uses. In other cases, emissions estimates can be developed as a percentage of production volume based upon consideration of use categories. Within a particular priority grouping, available emissions information can be considered for Second Tier rank ordering, with the understanding that emissions information is not an indicator of actual exposure. Similarly, non-isolated system intermediates, by definition, would have de minimis exposure potential. Therefore, this IUR information could be considered within a particular priority grouping for Second Tier rank ordering. International Risk Management Actions: An initial screening approach for chemical prioritization should be based upon consistent application of specific hazard and exposure science elements that define risk potential. The hazard and exposure elements should be applicable across all substances being evaluated. For initial screening, existence of international risk management action plans should not be a factor that determines priority grouping. Risk management plans may be based upon many factors, including political drivers. It is unclear how factors, their relative weighting, and the rigor of the evaluation may vary across agencies and substances. For initial screening August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 purposes, the same science-based criteria should be used to rank all substances. Consideration of existing international risk management plans could be utilized to check the functioning of the approach and could be considered within a particular priority grouping for Second Tier rank ordering with the possible effect of moving a chemical up in a grouping if actions are being taken internationally. IV. Summary ACC's prioritization approach is an example of a risk-based screening prioritization process that implements the general principles outlined at the outset of this document. It is based upon widely available information that can be utilized to understand the relative priority of chemicals for further evaluation from a risk perspective, i.e., integrating both hazard and exposure elements. Implementation of the screening framework will be most effective when utilizing the best available information. When conducting screening for thousands of chemicals, EPA may not have access to all available information. An open and iterative process that includes an opportunity for review and comment on initial rankings, together with the information that led to the result, and an opportunity to update the ranking with improved information will create a transparent and scientifically sound process. V. References Arnot, J.A., D. Mackay, T. F. Parkerton, R. T. Zaleski, C.S. Warren (2010), Multimedia modeling of human exposure to chemical substances: The roles of food web biomagnification and biotransformation, Environmental Toxicology and Chemistry 29(1):45-55. Boethling, R., K. Fenner, P. Howard, G. Klecka, T. Madsen, J.R. Snape, M.J. Whelan (2009). Environmental persistence of organic pollutants: guidance for development and review of POP risk profiles. Integrated Environmental Assessment and Management 5(4): 539 - 556. Gobas, F.A.P.C, W. de Wolf, L. P Burkhard, E. Verbruggen, K. Plotzke (2009). Revisiting Bioaccumulation Criteria for POPs and PBT Assessments Integrated Environmental Assessment and Management, 5(4):624-637. MacLeod, M., T. E. McKone (2004). Multimedia persistence as an indicator of potential for population-level intake of environmental contaminants, Environmental Toxicology and Chemistry 23(10):2465-2472. van Wijk,D., R. Chénier, T. Henry, M. D Hernando, C. Schulte (2009). Integrated Approach to PBT and POP Prioritization and Risk Assessment' Integrated Environmental Assessment and Management, 5(4):697-711. August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 Proposed Prioritization Approach DRAFT May & 2011 Exposure Elements nat commental consumer 20 2 3 a 33 3 not 8 or Persuntence S not 3 mai 35 a & not 3 Pas $ 3 S the iss = the Tormages RUN $ 3 3 SUM - P8 - Tavamage ranow 3 -13 Expesure Ramking $5 Based os Sum (UN# + pa * Townage PRIORITY GROUPING - Hazard * Expasure Ramkings - 1-8 3-10 11-13 mad Jow Hazard - Highter and Human $ 3 3 & $ Human Mazard Not on Dase 3 low mai * anou % 1000 numour 3 1.8 (duet Nume " 3 & 3 8 Not 100 Acure mi os : 3 A 2000 and not data) 280 v 1000 (pas 1.0 8.0 nomour 8.3 miss Nome 3 & % x CMR Cat 2, on Dawe Call 3: 10 - 3 is # 200 50 ase Igas 0.3 1.0 0.0% - 0.2 mis forme * # $ y GMS CMR Can on OHS Clowe Clat % Repeat Close 10 § on 8 on insurticient 20 information to - - - 0.3 wis 0,00 mist on information to $ 3 a $ August 29, 2011 Source: :https://www.industrydocuments.ucsf.edu/docs/jzbn0226 Hazard and Exposure Criteria for Prioritization Approach HAZARD EXPOSURE Environment and Human Health Classifications based upon GHS Use Elements - based upon IUR Intermediate consumed during industrial processing Envirommental: industrial (not intermediate) - used in an industrial setting From GHS classification guidance document: commercial occupational use in nonindustrial setting Table 4.1.2: scheme for substances hazardous so the aquatic environment. consumer general population residential use Clacufication Persistence: Loag-term Votalile substance (VPS 1000 Pax: Not Persistent if air half life <2 days a (Nate 2) Nonvolatile (VP < 1000 Pa): Not Persistent if: Adequate dass Adequnte voriciny dasa aux a) ready biodegradability (OBCD 301) Rapidly 3 b) inherent biodegradability (OBCD 301, 302, 306) degredable 0) read across from measured data on a related substance. 28 (Note. 3) d) equivalent degree of degradation (i.e. >20% in 28 days) via an abjotic Arute 3 Categorys Chronic 1 Categury: 1 Categasy: I degradation mechanism such as photolysis (OBCD 316) or hydrolysis (OBCD NOEC ar ECA 0.1 NOE - EC cass L 1.00 md of maid 111) and/ar BCF a 200 OR, a substance is Not Persistent if: if e) evaluation of simulation data from transformation in soil, marine water/sediment, Caregusy: Acore 2 Category: Chronic 2 Caregury: Chrumin 2 Caregusy: Chruaic 2 brackish water/sediment, surface water/sediment, oceanic water die away (e.g., OECD 3.00 s: s 10.9 0.1 - NOEC er EC. 13 0.00 <: NOEC - EC, 502 3.00 L(EXC) 10.8 and of andies 308/309) have half lives below 180 days. BCF = 500 as if K. 2 4 OR, if data are lacking: Caregusy: Arnie 3 Caregury: 3 Chrinia 3 f) evaluation via BIOWIN model (EPIWEB 4) 01 EC. : 30,00 1- 100 and fack of Bioaccomulation: stapoid andier BOF: Re 300 if absent log x 3 4 A substance is not bioaccumulative if: 4 4) a) measured TMF < 1 (field study) 3) b) measured fish BMF <1 (lab study) Ne tericity and lack of and BCF 2 500 ase, lag E 4, c) measured fish BCF < 5000 (lab study) MOECA 1 mal d) predicted BCP< 5000 using the BCFBAF model included in EPIWIN 4 The above order reflects the preference for use in decision- making NOTE -- P&B CRITERIA ARB FOR ORGANICS Tonnage - based upon JUR reporting ranges <. 25,000 lbs (below IUR site reporting limit) Human Health: 25.000 - <1 MM lbs national aggregate As above, based upon GHS 1MM - <100 MM lbs national aggregate >100 MM lbs national aggregate August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 Risk-Based Prioritization Matrix Ancreasing Exposure Two-Step towest Prionies Prioritization Process Incregaling Second Tier Rank Ordering within Priority Groups Biomonitoring / Environmental Monitoring Use in Children's Products Emissions (e.g. TRI) International Risk Management Actions Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226

which can be defined using a vapour presure cut-off ?

jzbn0226

jzbn0226_p28, jzbn0226_p29, jzbn0226_p30, jzbn0226_p31, jzbn0226_p32, jzbn0226_p33, jzbn0226_p34, jzbn0226_p35, jzbn0226_p36, jzbn0226_p37, jzbn0226_p38, jzbn0226_p39

volatile chemicals

endpoints, criteria are similarly available for both acute and chronic classification. The use of one common system allows for appropriate assessment of all substances. GHS classification information is readily available for all substances, as U.S. manufacturers have developed GHS classifications for their products to meet international requirements. ACC's support of the GHS criteria for purposes of this prioritization tool is not a categorical endorsement of the GHS criteria for any other purpose. ACC has been an active participant in the development of GHS and supports the system in principle. The GHS has not been broadly implemented to date in the U.S., although the Occupational Safety and Health Administration (OSHA) has indicated an intent to publish a regulation applying GHS in the workplace. ACC's December 29, 2009, comments on OSHA's proposed rule to modify the existing Hazard Communication Standard (HCS) to reflect the GHS urged that implementation of the GHS adhere to certain principles (e.g., continued application of the "Building Block Approach" of the Purple Book). ACC made specific recommendations concerning details of the Hazard Classification definitions, cut-off values, among others. ACC stands behind those comments. In ACC's view, the use of GHS criteria in a screening-level prioritization of chemicals can materially assist in determining which chemicals receive additional evaluation by the Environmental Protection Agency, but does not necessarily preclude the use of other appropriate, applicable criteria developed under other systems. To classify a chemical in a hazard based priority ranking where there is not direct data on the chemical, EPA can employ the full range of approaches, such as QSAR, SAR, read- across and other modeling tools in which EPA has confidence based on molecular structure. In those situations where there still remains insufficient information on either environmental or human health hazards, the chemical would be classified as "high" for its environmental or health ranking. 1. Environmental Ranking Table 1 provides a summary of how GHS criteria could be logically used for chemical management prioritization. Table 1. Environmental Safety - Hazard Ranking GHS Classification - Ranking Environmental Rank Environmental Score Acute I or Chronic I or Insufficient Information to High 4 Classify Acute II or Chronic II Medium High 3 Acute III or Chronic III/IV or Medium 2 none Not classified Low 1 August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 2. Human Health Ranking Table 2. Human Health - Hazard Ranking Health Rank GHS Classification - Human Health Ranking Score GHS CMR Cat 1a, 1b; OR Repeat Dose </= 10 mg/kg/day (oral); </= 20 mg/kg/day (dermal); </= 50 ppm/6hr/day (gas inhalation); High 4 <<= 0.2 mg/1/6h/day (vapour inhalation); </= 0.02 mg/l/6h/day (dust mist fume inhal). OR insufficient information to classify GHS CMR Cat 2; OR Repeat Dose 10 - 100 mg/kg/day (oral); 20 - 200 mg/kg/day (dermal); Medium High 50 - 250 ppm/6hr/day (gas inhalation); 3 0.2 - 1.0 mg/l/6h/day (vapour inhalation); 0.02 - 0.2 mg/l/6h/day (dust mist fume inhal). Not carcinogen/mutagen/repro/develop;OR Repeat Dose 100 - 1000 mg/kg/day (oral); 200 - 2000 mg/kg/day (dermal); Medium 250 - 1000 ppm/6hr/day (gas inhalation); 2 1.0 - 5.0 mg/l/6h/day (vapour inhalation); 0.2 - 1.0 mg/l/6h/day (dust mist fume inhal). Not carcinogen/mutagen/repro/develop; OR Repeat Dose >1000 mg/kg/day (oral); > 2000 mg/kg/day (dermal); Low > 1000 ppm/6hr/day (gas inhalation); 1 >5.0 mg/l/6h/day (vapour inhalation); > 1.0 mg/l/6h/day (dust mist fume inhal). It is important to note that specific concerns about children's health (specifically potential hazards and adverse effects on the nervous system) and those caused by endocrine disruption mechanisms are addressed in this prioritization process: The GHS CMR "R" classification includes specific evaluation of effects on development in utero and upon growth, maturation and reproduction. ("R" stands for reproductive toxicity and includes adverse effects on sexual function and fertility, as well as developmental toxicity in offspring). Endocrine activity is not a distinct toxicological hazard per se, but rather a measure of a compound's ability to interact with components of the endocrine system. The prioritization process evaluates data and information on relevant apical tests, including tests for reproduction and developmental toxicity (potential endocrine pathways). Thus, even if specific August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 screening for potential endocrine activity has not yet been conducted on certain compounds, hazard identification based on observable outcomes from apical toxicity tests (e.g., outcomes such as pathologic states indicative of disease conditions) covers all modes of action, including endocrine pathways. The toxicity information evaluated (CMR and repeat dose toxicity) is directly relevant to evaluating potential hazards to all individuals, including children. Such data typically includes: 1) identification and definition of possible hazards upon all major organ systems from both acute and repeated exposures, including the nervous system; 2) detection of potential hazards arising from in utero exposures, including possible effects on the nervous system; 3) evaluation of potential of a substance to affect reproduction; and 4) evaluation of the potential of a substance to damage DNA. Integration of Hazard Elements: Each of the environmental and human health classifications is assigned a numeric value based upon its ranking, with 1 being the lowest value and 4 the highest. The greatest ranking (highest hazard potential score) of either Environmental or Human Health is used in a substance- specific priority ranking. The numeric value does not imply relative weighting, but rather a numerical order of priority. B. Exposure Potential Ranking The screening method allows for an initial indication of the extent of exposure potential by considering: 1. The chemical's uses and use pattern(s) 2. Production volume as a first pass indicator of relative emission/release potential since magnitude and route (i.e. air, water, soil) of emissions is not available for all substances. 3. Persistence and bioaccumulation characteristics of the substance. Together the 3 elements are used to rank exposure potential. 1. Use Patterns The proposed approach applies the most current 2006 TSCA Inventory Update Reporting rule (IUR, now called the Chemical Data Reporting rule (CDR) data. To keep the initial prioritization simple and transparent, the approach "bins" different use patterns to align with general exposure potential - intermediates, industrial use, commercial use and consumer use. These patterns are the same as those reported in the IUR and are consistent with REACH exposure categories (intermediates, worker, professional, consumer). Chemicals with consumer product use are likely to have widespread potential for general population exposures and are given high priority ranking within the approach. For the initial prioritization approach, child specific products are captured under general consumer products and all consumer products are weighted equally (see additional discussion below under Second Tier Considerations). Intermediates will have low general population exposures, since these substances are consumed, by definition, within the workplace. Therefore, they are given the lowest priority ranking within the approach. In the context of the proposed approach, the intermediates category includes both intermediates and non-isolated intermediates. A chemical used in multiple use patterns is August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 assigned the priority of the highest use, e.g., a chemical in both industrial and commercial uses would be assigned the commercial Medium-High rank. Table 3. Use Patterns - Exposure Ranking Use Pattern Ranking Use Pattern Score Consumer High 4 Commercial Medium-High 3 Industrial Medium 2 Intermediates Low 1 The IUR Definitions of these terms are (40 CFR 710.3, 710.43): "consumer use" means the use of a chemical substance or a mixture containing a chemical substance (including as part of article) when sold to or made available to consumers for their use. "commercial use" means the use of a chemical substance or a mixture containing a chemical substance (including as part of an article) in a commercial enterprise providing saleable goods or services. "industrial use" means use at a site at which one or more chemical substances or mixtures are manufactured (including imported). "intermediate" means any chemical substance: which is intentionally removed from the equipment in which it is manufactured, and which either is consumed in whole or in part in chemical reaction(s) used for the intentional manufacture of other chemical substance(s) or mixture(s), or is intentionally present for the purpose of altering the rate of such chemical reaction(s) "non-isolated intermediate" means any intermediate that is not intentionally removed from the equipment in which is it manufactured, including the reaction vessel in which it is manufactured, equipment which is ancillary to the reaction vessel, and any equipment through which the substance passes during a continuous flow process, but not including tanks or other vessels in which the substance is stored after its manufacture. 2. Production Volume Recognizing that detailed exposure information will not be available for all substances to be screened, the proposed approach uses production volume as an indicator of exposure, which is widely used in many prioritization schemes. As production volume is just a rough surrogate of emissions, ACC suggests only very broad categories, covering about two orders of magnitude each. It may be useful to consider how additional exposure estimates may be applied in the second tier assessment. Table 4. Production Volume as Emission Surrogate - Exposure Ranking Production Volume as Emission Surrogate Ranking Volume Score >= 100,000,000 lbs national aggregate High 4 1,000,000 lbs to < 100,000,000 lbs national Medium - High 3 aggregate August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 >= 25,000 lbs to < 1,000,000 lbs national Medium 2 aggregate < 25,000 lbs (below IUR site reporting limit) Low 1 3. Persistence and Bioaccumulation Persistence and bioaccumulation are viewed as indicators of exposure, and therefore are considered under the exposure axis of the approach. A persistent substance that is emitted to the environment at the same rate as a non-persistent substance with similar partitioning properties will result in higher exposure to humans and the environment. In fact, multimedia modeling clearly indicates that environmental persistence in the compartment to which a substance partitions is a good indicator of human exposure potential (MacLeod & McKone et al. 2004). Similarly, substances that are not subject to biotransformation by higher organisms will exhibit a high bioaccumulation potential that results in higher exposures via the food chain (Arnot et al. 2010). Therefore, it is recommended to apply the proposed persistence and bioaccumulation criteria in assessment of exposure potential as described below. The persistent and bioaccumulative (P&B) criteria of the proposed approach are targeted toward organic chemicals. Separate assessment criteria are likely needed for P&B evaluation for inorganics/metals, as in the approach taken by Canada's Chemical Management Program (CMP). For assessing persistence, based upon recent expert consensus (Boethling et al., 2009) it is recommended to distinguish persistent from non-persistent chemicals using the following criteria: Volatile chemicals can be defined using a vapor pressure cut-off (i.e., > 1000 Pa) For volatile chemicals, persistent versus non-persistent chemicals are differentiated using a half-life cut-off in air (e.g., a substance is not persistent if air half life is < 2 days). For non-volatile chemicals, non-persistent substances can be defined as substances that are deemed: readily or inherently biodegradable using standard biodegradation tests (OECD 301, 302, 306 test guidelines) or SAR or read across from measured data on a related substance, show an equivalent degree of degradation (i.e. >20% in 28 days) via an abiotic degradation mechanism such as photolysis (OECD 316) or hydrolysi (OECD 111), evaluation of simulation data from transformation in soil, marine water/sediment, brackish water/sediment, surface water/sediment, oceanic water die away (e.g. OECD 308/309) have half lives below 180 days, OR if data are lacking, evaluation via BIOWIN model (EPIWEB 4) Non-volatile substances that are not biodegradable or subject to abiotic losses based on the above criteria would be considered persistent. For assessing bioaccumulation, the key question for screening is the potential for biomagnification based on recent expert consensus (Gobas et al. 2009). To determine if a substance has the potential to biomagnify the following metrics have been agreed: Trophic Magnification Factor (TMF)>1, fish Biomagnification Factor (BMF)>1 fish Bioaccumulation Factor (BAF)/Bioconcentration Factor (BCF) > 5000. These metrics can be August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 derived using lab or field measurements (where available) or recently improved computational models that are included in EPA's EPIWEB model that can be freely downloaded at www.epa.gov/oppt/exposure/pubs/episuite.htm. This approach allows all organics to be addressed and is a scientifically updated version of the approach used in Canada's CMP. Based on the above recommendations, substances can be grouped with regard to persistence and bioaccumulation as follows: Table 5. Persistence and Bioaccumulation - Exposure Ranking Persistence and P&B Ranking P&B Score Bioaccumulation Persistent and High 5 Bioaccumulative Persistent and Not Medium 3 Bioaccumulative OR Not Persistent and Bioaccumulative Not Persistent and Not Low 1 Bioaccumulative Integration of Exposure Elements: As demonstrated in the tables, each factor (use pattern, P&B, and production volume) would be assigned a numeric score based upon its ranking. All 3 factors are added to arrive at an overall value. These values are then separated into categories from low to high exposure potential. A proposed "banding" approach is illustrated in Table 6. Table 6. Integration of Exposure Rankings Combined Score - All 3 Exposure Rank Exposure Ranking elements Score 11 13 High 5 9 10 Medium High 4 7 8 Medium 3 5 6 Medium Low 2 3 4 Low 1 Overall Priority Grouping: In the overall approach, both hazard and exposure elements are considered when placing a substance in a risk-based prioritization ranking. The overall prioritization score for priority grouping and risk evaluation is based on the combined consideration of the hazard and exposure rankings. Priority Groups 7, 8, and 9 are deemed High Priority; Priority Groups 4, 5, and 6 are Medium Priority; and Priority Groups 2 and 3 are Low Priority. August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 Review and Comment: It is important that screening be done in an open and transparent way and that the best available information be used. When screening for thousands of chemicals, EPA may not have access to all available information. The process should provide an opportunity for review and comment on initial rankings and an opportunity to submit additional relevant data and information to update proposed rankings with improved information. III. Second Tier Considerations: After the initial screening, some substances within individual priority groupings may require further rank ordering, particularly where a large number of chemicals are in the same priority group. Listed below are the types of information that will be useful to consider in this Second Tier rank ordering: Biomonitoring/Environmental Monitoring Data: Mere detection of chemicals in humans or the environment, i.e., "found in biomonitoring (CDC), found in water (NCOD), and found in air", while providing an indication of exposure, does not provide a useful criterion for exposure potential because almost any industrial or commercial chemical could be detected at trace levels, given increasingly sensitive analytical methods. Therefore, detection alone primarily reflects only the fact that a specific chemical was included in a measurement program. This criterion will also tend to bias the prioritization of chemicals for which well-established analytical methods are available. Consequently, this criterion is not used in the initial prioritization scheme. However, within a particular priority grouping, reliable monitoring information should be considered for Second Tier rank ordering within a quantitative process that assesses if the data is above a level of concern (i.e., places it in a risk context). Use in Children's Products: Protection of childrens' health is a top priority and, in the initial ranking, child-specific products are captured under general consumer products and all consumer products are weighted equally. The specific IUR reporting of information on chemical use in products intended for children would be considered further within a particular priority grouping for Second Tier rank ordering, noting the following points: the IUR definition is based upon use in a child specific product rather than child specific exposure potential¹ (see below). Without knowing a specific product type, it is difficult to understand if 1 IUR definition (Federal Register Volume 75, Number 156, Friday August 30, 2010, p. 49686): Intended for use by children means the chemical substance or mixture is used in or on a product that is specifically intended for use by children age 14 or younger. A chemical substance or mixture is intended for use by children when the submitter answers "yes" to at least on of the following questions for the product into which the submitter's chemical substance or mixture is incorporated: (1) Is the product commonly recognized (i.e., by a reasonable person) as being intended for children age 14 or younger? (2) Does the manufacturer of the product state through product labeling or other written materials that the product is intended for or will be used by children age 14 or younger? (3) Is the advertising, promotion, or marketing of the product aimed at children age 14 or younger? August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 potential child exposure is greater than for a non-child specific product. For example, how does child exposure to a general use cleaner compare to exposure from use in a child's raincoat. In the VCCEP assessments, there are examples for inhalation exposures where estimates of passive child exposure during adult product use exceeded conservative estimates of child exposure during active use of a child-specific product (such as a hobby product) - differences were related to the amount of product used and substance concentration within the product (MEK VCCEP Submission). the IUR definition targets children age 14 and younger. Younger children may be exposed to a variety of non-child specific products that are in general household use. Older children may be exposed to a variety of additional products. the IUR information request is targeted to manufacturers, which may not have direct knowledge of all uses, particularly the presence in products for specific subpopulations, such as children. Therefore, it is not clear that the information requested for the IUR information would be consistently available across all substances being screened. Ideally, this information should be requested from formulators of child-specific products. Therefore, for the initial prioritization approach, which represents a broad, unrefined categorization, child specific products are captured under general consumer products and all consumer products are weighted equally. The IUR information on child specific use would be utilized within a particular priority grouping for Second Tier rank ordering. If the IUR information is utilized, it is important that the limitations above be considered in its application. Emissions Data: Production volume, which is readily available for substances, is used in this proposed approach, but only serves as a surrogate for environmental emissions. For further prioritization, data or estimates of environmental emissions can be used to refine prioritization. Estimates of environmental emissions will be available for some substances (e.g., TRI data). When TRI data are utilized it should be recognized that it addresses only emissions that result from industrial and not wide dispersive uses. In other cases, emissions estimates can be developed as a percentage of production volume based upon consideration of use categories. Within a particular priority grouping, available emissions information can be considered for Second Tier rank ordering, with the understanding that emissions information is not an indicator of actual exposure. Similarly, non-isolated system intermediates, by definition, would have de minimis exposure potential. Therefore, this IUR information could be considered within a particular priority grouping for Second Tier rank ordering. International Risk Management Actions: An initial screening approach for chemical prioritization should be based upon consistent application of specific hazard and exposure science elements that define risk potential. The hazard and exposure elements should be applicable across all substances being evaluated. For initial screening, existence of international risk management action plans should not be a factor that determines priority grouping. Risk management plans may be based upon many factors, including political drivers. It is unclear how factors, their relative weighting, and the rigor of the evaluation may vary across agencies and substances. For initial screening August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 purposes, the same science-based criteria should be used to rank all substances. Consideration of existing international risk management plans could be utilized to check the functioning of the approach and could be considered within a particular priority grouping for Second Tier rank ordering with the possible effect of moving a chemical up in a grouping if actions are being taken internationally. IV. Summary ACC's prioritization approach is an example of a risk-based screening prioritization process that implements the general principles outlined at the outset of this document. It is based upon widely available information that can be utilized to understand the relative priority of chemicals for further evaluation from a risk perspective, i.e., integrating both hazard and exposure elements. Implementation of the screening framework will be most effective when utilizing the best available information. When conducting screening for thousands of chemicals, EPA may not have access to all available information. An open and iterative process that includes an opportunity for review and comment on initial rankings, together with the information that led to the result, and an opportunity to update the ranking with improved information will create a transparent and scientifically sound process. V. References Arnot, J.A., D. Mackay, T. F. Parkerton, R. T. Zaleski, C.S. Warren (2010), Multimedia modeling of human exposure to chemical substances: The roles of food web biomagnification and biotransformation, Environmental Toxicology and Chemistry 29(1):45-55. Boethling, R., K. Fenner, P. Howard, G. Klecka, T. Madsen, J.R. Snape, M.J. Whelan (2009). Environmental persistence of organic pollutants: guidance for development and review of POP risk profiles. Integrated Environmental Assessment and Management 5(4): 539 - 556. Gobas, F.A.P.C, W. de Wolf, L. P Burkhard, E. Verbruggen, K. Plotzke (2009). Revisiting Bioaccumulation Criteria for POPs and PBT Assessments Integrated Environmental Assessment and Management, 5(4):624-637. MacLeod, M., T. E. McKone (2004). Multimedia persistence as an indicator of potential for population-level intake of environmental contaminants, Environmental Toxicology and Chemistry 23(10):2465-2472. van Wijk,D., R. Chénier, T. Henry, M. D Hernando, C. Schulte (2009). Integrated Approach to PBT and POP Prioritization and Risk Assessment' Integrated Environmental Assessment and Management, 5(4):697-711. August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 Proposed Prioritization Approach DRAFT May & 2011 Exposure Elements nat commental consumer 20 2 3 a 33 3 not 8 or Persuntence S not 3 mai 35 a & not 3 Pas $ 3 S the iss = the Tormages RUN $ 3 3 SUM - P8 - Tavamage ranow 3 -13 Expesure Ramking $5 Based os Sum (UN# + pa * Townage PRIORITY GROUPING - Hazard * Expasure Ramkings - 1-8 3-10 11-13 mad Jow Hazard - Highter and Human $ 3 3 & $ Human Mazard Not on Dase 3 low mai * anou % 1000 numour 3 1.8 (duet Nume " 3 & 3 8 Not 100 Acure mi os : 3 A 2000 and not data) 280 v 1000 (pas 1.0 8.0 nomour 8.3 miss Nome 3 & % x CMR Cat 2, on Dawe Call 3: 10 - 3 is # 200 50 ase Igas 0.3 1.0 0.0% - 0.2 mis forme * # $ y GMS CMR Can on OHS Clowe Clat % Repeat Close 10 § on 8 on insurticient 20 information to - - - 0.3 wis 0,00 mist on information to $ 3 a $ August 29, 2011 Source: :https://www.industrydocuments.ucsf.edu/docs/jzbn0226 Hazard and Exposure Criteria for Prioritization Approach HAZARD EXPOSURE Environment and Human Health Classifications based upon GHS Use Elements - based upon IUR Intermediate consumed during industrial processing Envirommental: industrial (not intermediate) - used in an industrial setting From GHS classification guidance document: commercial occupational use in nonindustrial setting Table 4.1.2: scheme for substances hazardous so the aquatic environment. consumer general population residential use Clacufication Persistence: Loag-term Votalile substance (VPS 1000 Pax: Not Persistent if air half life <2 days a (Nate 2) Nonvolatile (VP < 1000 Pa): Not Persistent if: Adequate dass Adequnte voriciny dasa aux a) ready biodegradability (OBCD 301) Rapidly 3 b) inherent biodegradability (OBCD 301, 302, 306) degredable 0) read across from measured data on a related substance. 28 (Note. 3) d) equivalent degree of degradation (i.e. >20% in 28 days) via an abjotic Arute 3 Categorys Chronic 1 Categury: 1 Categasy: I degradation mechanism such as photolysis (OBCD 316) or hydrolysis (OBCD NOEC ar ECA 0.1 NOE - EC cass L 1.00 md of maid 111) and/ar BCF a 200 OR, a substance is Not Persistent if: if e) evaluation of simulation data from transformation in soil, marine water/sediment, Caregusy: Acore 2 Category: Chronic 2 Caregury: Chrumin 2 Caregusy: Chruaic 2 brackish water/sediment, surface water/sediment, oceanic water die away (e.g., OECD 3.00 s: s 10.9 0.1 - NOEC er EC. 13 0.00 <: NOEC - EC, 502 3.00 L(EXC) 10.8 and of andies 308/309) have half lives below 180 days. BCF = 500 as if K. 2 4 OR, if data are lacking: Caregusy: Arnie 3 Caregury: 3 Chrinia 3 f) evaluation via BIOWIN model (EPIWEB 4) 01 EC. : 30,00 1- 100 and fack of Bioaccomulation: stapoid andier BOF: Re 300 if absent log x 3 4 A substance is not bioaccumulative if: 4 4) a) measured TMF < 1 (field study) 3) b) measured fish BMF <1 (lab study) Ne tericity and lack of and BCF 2 500 ase, lag E 4, c) measured fish BCF < 5000 (lab study) MOECA 1 mal d) predicted BCP< 5000 using the BCFBAF model included in EPIWIN 4 The above order reflects the preference for use in decision- making NOTE -- P&B CRITERIA ARB FOR ORGANICS Tonnage - based upon JUR reporting ranges <. 25,000 lbs (below IUR site reporting limit) Human Health: 25.000 - <1 MM lbs national aggregate As above, based upon GHS 1MM - <100 MM lbs national aggregate >100 MM lbs national aggregate August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 Risk-Based Prioritization Matrix Ancreasing Exposure Two-Step towest Prionies Prioritization Process Incregaling Second Tier Rank Ordering within Priority Groups Biomonitoring / Environmental Monitoring Use in Children's Products Emissions (e.g. TRI) International Risk Management Actions Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226

EPA might consider risk evaluations over time based on which century's tools and methods?

jzbn0226

jzbn0226_p24, jzbn0226_p25, jzbn0226_p26

21st, 21st century, 21st Century tools and methods, 21st Century

C. Waivers EPA has proposed that all comments that could be raised on issues in a proposed low priority designation be presented during the comment period, and that any issues not raised then be considered to have been waived. Waived issues could not form the basis of an objection or challenge in any subsequent administrative or judicial proceeding on the designation of the substance as a low priority substance (which is subject to judicial review). EPA points to the statutory deadlines in the prioritization process as the policy justification for this proposal. 38 ACC urges EPA to remove this waiver requirement from the prioritization rule. First, it is inconsistent with Congress's intent that the prioritization process be iterative and science-based. Low priority designations should be able to be modified - expanded or contracted - based on new information that is brought to the Agency's attention after the designation. This new information might not have been known during the public comment period on the low priority designation. It would be bad public policy to consider new information waived because that could discourage stakeholders from gathering or developing relevant information about a chemical. Second, participation in the notice and comment rulemaking process of prioritization is governed by statute - through the Administrative Procedures Act (APA) and the judicial review provisions of Section 19 of TSCA. There are no issue exhaustion provisions in TSCA. EPA cannot by regulation, impose an issue exhaustion requirement that trumps the statutory rights and obligations of stakeholders under the APA and TSCA Section 19.39 D. Definitions As an addendum to ACC's recommendations for EPA to reference the Section 26 science standards in the prioritization process rule, ACC offers the following definitions for EPA's consideration: Best available science means information that has been evaluated based on its strengths, limitations and relevance and the Agency is relying on the highest quality information. In evaluating best available science the Agency will also consider the peer review of the science, whether the study was conducted in accordance with sound and objective practices, and if the data were collected by accepted methods or best available methods. To ensure transparency regarding best available science the Agency will describe and document any assumptions and methods used, and address variability, uncertainty, the degree of independent verification and peer review. Weight of the evidence means a systematic review method that uses a pre-established protocol to comprehensively, objectively, transparently, and consistently, identify and evaluate each stream of evidence, including strengths, limitations, and relevance of each study and to integrate evidence as necessary and appropriate based upon strengths, limitations, and relevance. 38 Id. at 4833. 39 See ACC Comments on EPA's Proposed Rule: Procedures for Chemical Risk Evaluation under the Amended Toxic Substances Control Act (RIN 2070- AK20) for additional discussion of the waiver/lock down/issue exhaustion issue. 23 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 E. Repopulation of High Priority Substances EPA's preamble discussion of the "repopulation" of high priority substances40 presents a reasonable approach by which the Agency could meet the LCSA obligation to finalize the designation of one new high priority substance upon completion of a risk evaluation for another substance. The one-for-one approach makes sense as this program gets underway. ACC suggests, however, that EPA consider a placeholder in its rule to anticipate changes in the rate at which EPA might be able to conduct risk evaluations over time (based on use of 21st Century tools and methods) and hence potentially change the rate at which EPA may need to designate high priorities for risk evaluation. VIII. Summary of ACC's Recommendations: Throughout these comments, ACC has included many specific recommendations for EPA to consider as it develops its final prioritization process rule to address ACC's concerns about the proposed rule. These recommendations urge EPA to direct its authority on what it is mandated to do under the LCSA - designate high priority and low priority chemicals for risk evaluations in accordance with both the criteria in LCSA Section 6 and the LCSA Section 26 science based standards. To help the regulated community provide EPA the information the Agency will need to prioritize chemicals for risk evaluations, EPA must clarify the prioritization process as a whole and develop an efficient and focused prioritization process rule that meets the LCSA mandate and Congressional intent. ACC strongly urges EPA to amend its proposal to include these suggested recommendations and seek public comment before finalizing the prioritization process rule. Alternatively, EPA should propose a supplemental rule providing more detail and clarifications on the prioritization process steps involved and finalize it prior to the Agency's first application of the prioritization process . To help foster the submission of information needed to prioritize chemicals for risk evaluations, EPA must ultimately develop an efficient and focused prioritization process rule that clearly lays out the major steps for meeting its mandate. 40 82 Fed. Reg. at 4833. 24 Source: :ttps://www.industrydocuments.ucsf.edu/docs/jzbn0226 Attachment A ACC's General Principles on Prioritization (Developed for EPA Dialogue 7-2011) EPA should systematically prioritize chemicals for purposes of safe use determinations. As a general matter, prioritization should be based on existing hazard and exposure data and information (including models, read across, QSAR, etc.) and industry should be responsible for providing EPA with this data and information. Chemicals lacking adequate hazard and exposure information should be considered a higher priority (until relevant information is provided that suggests otherwise). Industry should be provided an opportunity to provide EPA additional data/information. (Timing is an issue, however. And the format in which the information is provided to EPA must be useable/digestible by EPA, e.g. robust summaries.) Hazard, use and exposure based criteria should be integrated to form the basis for EPA's prioritization decisions. Prioritization should not be based on either hazard-only or exposure-only information. The prioritization process and science based criteria that EPA uses to prioritize chemicals must be transparent. Prioritization should be a dynamic, iterative process. Re-examination of priorities should occur as new information becomes available and as new chemicals are approved for manufacturing. For prioritization to be successful, it must include three critical elements: reliable and up- to- date chemical data and information; evaluation criteria that consider both hazard and exposure information together; and established cutoffs to make priority decisions. EPA's communication about priority chemicals must be clear about what the list is and what it is not, to avoid unintended consequences of product de-selection purely on the basis of listing. Transparency; consistent, scientific criteria; intersection of both hazard and exposure information; dynamic process so new information can be incorporated as it is made available and so if priorities are initially "wrong" they can be corrected. 25 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226

What is the heading of the second paragraph?

jzbn0226

jzbn0226_p24, jzbn0226_p25, jzbn0226_p26

"Summary of ACCs Recommendations:", "Summary of ACCs Recommendations", "VIII. Summary of ACCs Recommendations:"

C. Waivers EPA has proposed that all comments that could be raised on issues in a proposed low priority designation be presented during the comment period, and that any issues not raised then be considered to have been waived. Waived issues could not form the basis of an objection or challenge in any subsequent administrative or judicial proceeding on the designation of the substance as a low priority substance (which is subject to judicial review). EPA points to the statutory deadlines in the prioritization process as the policy justification for this proposal. 38 ACC urges EPA to remove this waiver requirement from the prioritization rule. First, it is inconsistent with Congress's intent that the prioritization process be iterative and science-based. Low priority designations should be able to be modified - expanded or contracted - based on new information that is brought to the Agency's attention after the designation. This new information might not have been known during the public comment period on the low priority designation. It would be bad public policy to consider new information waived because that could discourage stakeholders from gathering or developing relevant information about a chemical. Second, participation in the notice and comment rulemaking process of prioritization is governed by statute - through the Administrative Procedures Act (APA) and the judicial review provisions of Section 19 of TSCA. There are no issue exhaustion provisions in TSCA. EPA cannot by regulation, impose an issue exhaustion requirement that trumps the statutory rights and obligations of stakeholders under the APA and TSCA Section 19.39 D. Definitions As an addendum to ACC's recommendations for EPA to reference the Section 26 science standards in the prioritization process rule, ACC offers the following definitions for EPA's consideration: Best available science means information that has been evaluated based on its strengths, limitations and relevance and the Agency is relying on the highest quality information. In evaluating best available science the Agency will also consider the peer review of the science, whether the study was conducted in accordance with sound and objective practices, and if the data were collected by accepted methods or best available methods. To ensure transparency regarding best available science the Agency will describe and document any assumptions and methods used, and address variability, uncertainty, the degree of independent verification and peer review. Weight of the evidence means a systematic review method that uses a pre-established protocol to comprehensively, objectively, transparently, and consistently, identify and evaluate each stream of evidence, including strengths, limitations, and relevance of each study and to integrate evidence as necessary and appropriate based upon strengths, limitations, and relevance. 38 Id. at 4833. 39 See ACC Comments on EPA's Proposed Rule: Procedures for Chemical Risk Evaluation under the Amended Toxic Substances Control Act (RIN 2070- AK20) for additional discussion of the waiver/lock down/issue exhaustion issue. 23 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 E. Repopulation of High Priority Substances EPA's preamble discussion of the "repopulation" of high priority substances40 presents a reasonable approach by which the Agency could meet the LCSA obligation to finalize the designation of one new high priority substance upon completion of a risk evaluation for another substance. The one-for-one approach makes sense as this program gets underway. ACC suggests, however, that EPA consider a placeholder in its rule to anticipate changes in the rate at which EPA might be able to conduct risk evaluations over time (based on use of 21st Century tools and methods) and hence potentially change the rate at which EPA may need to designate high priorities for risk evaluation. VIII. Summary of ACC's Recommendations: Throughout these comments, ACC has included many specific recommendations for EPA to consider as it develops its final prioritization process rule to address ACC's concerns about the proposed rule. These recommendations urge EPA to direct its authority on what it is mandated to do under the LCSA - designate high priority and low priority chemicals for risk evaluations in accordance with both the criteria in LCSA Section 6 and the LCSA Section 26 science based standards. To help the regulated community provide EPA the information the Agency will need to prioritize chemicals for risk evaluations, EPA must clarify the prioritization process as a whole and develop an efficient and focused prioritization process rule that meets the LCSA mandate and Congressional intent. ACC strongly urges EPA to amend its proposal to include these suggested recommendations and seek public comment before finalizing the prioritization process rule. Alternatively, EPA should propose a supplemental rule providing more detail and clarifications on the prioritization process steps involved and finalize it prior to the Agency's first application of the prioritization process . To help foster the submission of information needed to prioritize chemicals for risk evaluations, EPA must ultimately develop an efficient and focused prioritization process rule that clearly lays out the major steps for meeting its mandate. 40 82 Fed. Reg. at 4833. 24 Source: :ttps://www.industrydocuments.ucsf.edu/docs/jzbn0226 Attachment A ACC's General Principles on Prioritization (Developed for EPA Dialogue 7-2011) EPA should systematically prioritize chemicals for purposes of safe use determinations. As a general matter, prioritization should be based on existing hazard and exposure data and information (including models, read across, QSAR, etc.) and industry should be responsible for providing EPA with this data and information. Chemicals lacking adequate hazard and exposure information should be considered a higher priority (until relevant information is provided that suggests otherwise). Industry should be provided an opportunity to provide EPA additional data/information. (Timing is an issue, however. And the format in which the information is provided to EPA must be useable/digestible by EPA, e.g. robust summaries.) Hazard, use and exposure based criteria should be integrated to form the basis for EPA's prioritization decisions. Prioritization should not be based on either hazard-only or exposure-only information. The prioritization process and science based criteria that EPA uses to prioritize chemicals must be transparent. Prioritization should be a dynamic, iterative process. Re-examination of priorities should occur as new information becomes available and as new chemicals are approved for manufacturing. For prioritization to be successful, it must include three critical elements: reliable and up- to- date chemical data and information; evaluation criteria that consider both hazard and exposure information together; and established cutoffs to make priority decisions. EPA's communication about priority chemicals must be clear about what the list is and what it is not, to avoid unintended consequences of product de-selection purely on the basis of listing. Transparency; consistent, scientific criteria; intersection of both hazard and exposure information; dynamic process so new information can be incorporated as it is made available and so if priorities are initially "wrong" they can be corrected. 25 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226

what does TMF stands for?

jzbn0226

jzbn0226_p28, jzbn0226_p29, jzbn0226_p30, jzbn0226_p31, jzbn0226_p32, jzbn0226_p33, jzbn0226_p34, jzbn0226_p35, jzbn0226_p36, jzbn0226_p37, jzbn0226_p38, jzbn0226_p39

trophic magnification factor

endpoints, criteria are similarly available for both acute and chronic classification. The use of one common system allows for appropriate assessment of all substances. GHS classification information is readily available for all substances, as U.S. manufacturers have developed GHS classifications for their products to meet international requirements. ACC's support of the GHS criteria for purposes of this prioritization tool is not a categorical endorsement of the GHS criteria for any other purpose. ACC has been an active participant in the development of GHS and supports the system in principle. The GHS has not been broadly implemented to date in the U.S., although the Occupational Safety and Health Administration (OSHA) has indicated an intent to publish a regulation applying GHS in the workplace. ACC's December 29, 2009, comments on OSHA's proposed rule to modify the existing Hazard Communication Standard (HCS) to reflect the GHS urged that implementation of the GHS adhere to certain principles (e.g., continued application of the "Building Block Approach" of the Purple Book). ACC made specific recommendations concerning details of the Hazard Classification definitions, cut-off values, among others. ACC stands behind those comments. In ACC's view, the use of GHS criteria in a screening-level prioritization of chemicals can materially assist in determining which chemicals receive additional evaluation by the Environmental Protection Agency, but does not necessarily preclude the use of other appropriate, applicable criteria developed under other systems. To classify a chemical in a hazard based priority ranking where there is not direct data on the chemical, EPA can employ the full range of approaches, such as QSAR, SAR, read- across and other modeling tools in which EPA has confidence based on molecular structure. In those situations where there still remains insufficient information on either environmental or human health hazards, the chemical would be classified as "high" for its environmental or health ranking. 1. Environmental Ranking Table 1 provides a summary of how GHS criteria could be logically used for chemical management prioritization. Table 1. Environmental Safety - Hazard Ranking GHS Classification - Ranking Environmental Rank Environmental Score Acute I or Chronic I or Insufficient Information to High 4 Classify Acute II or Chronic II Medium High 3 Acute III or Chronic III/IV or Medium 2 none Not classified Low 1 August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 2. Human Health Ranking Table 2. Human Health - Hazard Ranking Health Rank GHS Classification - Human Health Ranking Score GHS CMR Cat 1a, 1b; OR Repeat Dose </= 10 mg/kg/day (oral); </= 20 mg/kg/day (dermal); </= 50 ppm/6hr/day (gas inhalation); High 4 <<= 0.2 mg/1/6h/day (vapour inhalation); </= 0.02 mg/l/6h/day (dust mist fume inhal). OR insufficient information to classify GHS CMR Cat 2; OR Repeat Dose 10 - 100 mg/kg/day (oral); 20 - 200 mg/kg/day (dermal); Medium High 50 - 250 ppm/6hr/day (gas inhalation); 3 0.2 - 1.0 mg/l/6h/day (vapour inhalation); 0.02 - 0.2 mg/l/6h/day (dust mist fume inhal). Not carcinogen/mutagen/repro/develop;OR Repeat Dose 100 - 1000 mg/kg/day (oral); 200 - 2000 mg/kg/day (dermal); Medium 250 - 1000 ppm/6hr/day (gas inhalation); 2 1.0 - 5.0 mg/l/6h/day (vapour inhalation); 0.2 - 1.0 mg/l/6h/day (dust mist fume inhal). Not carcinogen/mutagen/repro/develop; OR Repeat Dose >1000 mg/kg/day (oral); > 2000 mg/kg/day (dermal); Low > 1000 ppm/6hr/day (gas inhalation); 1 >5.0 mg/l/6h/day (vapour inhalation); > 1.0 mg/l/6h/day (dust mist fume inhal). It is important to note that specific concerns about children's health (specifically potential hazards and adverse effects on the nervous system) and those caused by endocrine disruption mechanisms are addressed in this prioritization process: The GHS CMR "R" classification includes specific evaluation of effects on development in utero and upon growth, maturation and reproduction. ("R" stands for reproductive toxicity and includes adverse effects on sexual function and fertility, as well as developmental toxicity in offspring). Endocrine activity is not a distinct toxicological hazard per se, but rather a measure of a compound's ability to interact with components of the endocrine system. The prioritization process evaluates data and information on relevant apical tests, including tests for reproduction and developmental toxicity (potential endocrine pathways). Thus, even if specific August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 screening for potential endocrine activity has not yet been conducted on certain compounds, hazard identification based on observable outcomes from apical toxicity tests (e.g., outcomes such as pathologic states indicative of disease conditions) covers all modes of action, including endocrine pathways. The toxicity information evaluated (CMR and repeat dose toxicity) is directly relevant to evaluating potential hazards to all individuals, including children. Such data typically includes: 1) identification and definition of possible hazards upon all major organ systems from both acute and repeated exposures, including the nervous system; 2) detection of potential hazards arising from in utero exposures, including possible effects on the nervous system; 3) evaluation of potential of a substance to affect reproduction; and 4) evaluation of the potential of a substance to damage DNA. Integration of Hazard Elements: Each of the environmental and human health classifications is assigned a numeric value based upon its ranking, with 1 being the lowest value and 4 the highest. The greatest ranking (highest hazard potential score) of either Environmental or Human Health is used in a substance- specific priority ranking. The numeric value does not imply relative weighting, but rather a numerical order of priority. B. Exposure Potential Ranking The screening method allows for an initial indication of the extent of exposure potential by considering: 1. The chemical's uses and use pattern(s) 2. Production volume as a first pass indicator of relative emission/release potential since magnitude and route (i.e. air, water, soil) of emissions is not available for all substances. 3. Persistence and bioaccumulation characteristics of the substance. Together the 3 elements are used to rank exposure potential. 1. Use Patterns The proposed approach applies the most current 2006 TSCA Inventory Update Reporting rule (IUR, now called the Chemical Data Reporting rule (CDR) data. To keep the initial prioritization simple and transparent, the approach "bins" different use patterns to align with general exposure potential - intermediates, industrial use, commercial use and consumer use. These patterns are the same as those reported in the IUR and are consistent with REACH exposure categories (intermediates, worker, professional, consumer). Chemicals with consumer product use are likely to have widespread potential for general population exposures and are given high priority ranking within the approach. For the initial prioritization approach, child specific products are captured under general consumer products and all consumer products are weighted equally (see additional discussion below under Second Tier Considerations). Intermediates will have low general population exposures, since these substances are consumed, by definition, within the workplace. Therefore, they are given the lowest priority ranking within the approach. In the context of the proposed approach, the intermediates category includes both intermediates and non-isolated intermediates. A chemical used in multiple use patterns is August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 assigned the priority of the highest use, e.g., a chemical in both industrial and commercial uses would be assigned the commercial Medium-High rank. Table 3. Use Patterns - Exposure Ranking Use Pattern Ranking Use Pattern Score Consumer High 4 Commercial Medium-High 3 Industrial Medium 2 Intermediates Low 1 The IUR Definitions of these terms are (40 CFR 710.3, 710.43): "consumer use" means the use of a chemical substance or a mixture containing a chemical substance (including as part of article) when sold to or made available to consumers for their use. "commercial use" means the use of a chemical substance or a mixture containing a chemical substance (including as part of an article) in a commercial enterprise providing saleable goods or services. "industrial use" means use at a site at which one or more chemical substances or mixtures are manufactured (including imported). "intermediate" means any chemical substance: which is intentionally removed from the equipment in which it is manufactured, and which either is consumed in whole or in part in chemical reaction(s) used for the intentional manufacture of other chemical substance(s) or mixture(s), or is intentionally present for the purpose of altering the rate of such chemical reaction(s) "non-isolated intermediate" means any intermediate that is not intentionally removed from the equipment in which is it manufactured, including the reaction vessel in which it is manufactured, equipment which is ancillary to the reaction vessel, and any equipment through which the substance passes during a continuous flow process, but not including tanks or other vessels in which the substance is stored after its manufacture. 2. Production Volume Recognizing that detailed exposure information will not be available for all substances to be screened, the proposed approach uses production volume as an indicator of exposure, which is widely used in many prioritization schemes. As production volume is just a rough surrogate of emissions, ACC suggests only very broad categories, covering about two orders of magnitude each. It may be useful to consider how additional exposure estimates may be applied in the second tier assessment. Table 4. Production Volume as Emission Surrogate - Exposure Ranking Production Volume as Emission Surrogate Ranking Volume Score >= 100,000,000 lbs national aggregate High 4 1,000,000 lbs to < 100,000,000 lbs national Medium - High 3 aggregate August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 >= 25,000 lbs to < 1,000,000 lbs national Medium 2 aggregate < 25,000 lbs (below IUR site reporting limit) Low 1 3. Persistence and Bioaccumulation Persistence and bioaccumulation are viewed as indicators of exposure, and therefore are considered under the exposure axis of the approach. A persistent substance that is emitted to the environment at the same rate as a non-persistent substance with similar partitioning properties will result in higher exposure to humans and the environment. In fact, multimedia modeling clearly indicates that environmental persistence in the compartment to which a substance partitions is a good indicator of human exposure potential (MacLeod & McKone et al. 2004). Similarly, substances that are not subject to biotransformation by higher organisms will exhibit a high bioaccumulation potential that results in higher exposures via the food chain (Arnot et al. 2010). Therefore, it is recommended to apply the proposed persistence and bioaccumulation criteria in assessment of exposure potential as described below. The persistent and bioaccumulative (P&B) criteria of the proposed approach are targeted toward organic chemicals. Separate assessment criteria are likely needed for P&B evaluation for inorganics/metals, as in the approach taken by Canada's Chemical Management Program (CMP). For assessing persistence, based upon recent expert consensus (Boethling et al., 2009) it is recommended to distinguish persistent from non-persistent chemicals using the following criteria: Volatile chemicals can be defined using a vapor pressure cut-off (i.e., > 1000 Pa) For volatile chemicals, persistent versus non-persistent chemicals are differentiated using a half-life cut-off in air (e.g., a substance is not persistent if air half life is < 2 days). For non-volatile chemicals, non-persistent substances can be defined as substances that are deemed: readily or inherently biodegradable using standard biodegradation tests (OECD 301, 302, 306 test guidelines) or SAR or read across from measured data on a related substance, show an equivalent degree of degradation (i.e. >20% in 28 days) via an abiotic degradation mechanism such as photolysis (OECD 316) or hydrolysi (OECD 111), evaluation of simulation data from transformation in soil, marine water/sediment, brackish water/sediment, surface water/sediment, oceanic water die away (e.g. OECD 308/309) have half lives below 180 days, OR if data are lacking, evaluation via BIOWIN model (EPIWEB 4) Non-volatile substances that are not biodegradable or subject to abiotic losses based on the above criteria would be considered persistent. For assessing bioaccumulation, the key question for screening is the potential for biomagnification based on recent expert consensus (Gobas et al. 2009). To determine if a substance has the potential to biomagnify the following metrics have been agreed: Trophic Magnification Factor (TMF)>1, fish Biomagnification Factor (BMF)>1 fish Bioaccumulation Factor (BAF)/Bioconcentration Factor (BCF) > 5000. These metrics can be August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 derived using lab or field measurements (where available) or recently improved computational models that are included in EPA's EPIWEB model that can be freely downloaded at www.epa.gov/oppt/exposure/pubs/episuite.htm. This approach allows all organics to be addressed and is a scientifically updated version of the approach used in Canada's CMP. Based on the above recommendations, substances can be grouped with regard to persistence and bioaccumulation as follows: Table 5. Persistence and Bioaccumulation - Exposure Ranking Persistence and P&B Ranking P&B Score Bioaccumulation Persistent and High 5 Bioaccumulative Persistent and Not Medium 3 Bioaccumulative OR Not Persistent and Bioaccumulative Not Persistent and Not Low 1 Bioaccumulative Integration of Exposure Elements: As demonstrated in the tables, each factor (use pattern, P&B, and production volume) would be assigned a numeric score based upon its ranking. All 3 factors are added to arrive at an overall value. These values are then separated into categories from low to high exposure potential. A proposed "banding" approach is illustrated in Table 6. Table 6. Integration of Exposure Rankings Combined Score - All 3 Exposure Rank Exposure Ranking elements Score 11 13 High 5 9 10 Medium High 4 7 8 Medium 3 5 6 Medium Low 2 3 4 Low 1 Overall Priority Grouping: In the overall approach, both hazard and exposure elements are considered when placing a substance in a risk-based prioritization ranking. The overall prioritization score for priority grouping and risk evaluation is based on the combined consideration of the hazard and exposure rankings. Priority Groups 7, 8, and 9 are deemed High Priority; Priority Groups 4, 5, and 6 are Medium Priority; and Priority Groups 2 and 3 are Low Priority. August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 Review and Comment: It is important that screening be done in an open and transparent way and that the best available information be used. When screening for thousands of chemicals, EPA may not have access to all available information. The process should provide an opportunity for review and comment on initial rankings and an opportunity to submit additional relevant data and information to update proposed rankings with improved information. III. Second Tier Considerations: After the initial screening, some substances within individual priority groupings may require further rank ordering, particularly where a large number of chemicals are in the same priority group. Listed below are the types of information that will be useful to consider in this Second Tier rank ordering: Biomonitoring/Environmental Monitoring Data: Mere detection of chemicals in humans or the environment, i.e., "found in biomonitoring (CDC), found in water (NCOD), and found in air", while providing an indication of exposure, does not provide a useful criterion for exposure potential because almost any industrial or commercial chemical could be detected at trace levels, given increasingly sensitive analytical methods. Therefore, detection alone primarily reflects only the fact that a specific chemical was included in a measurement program. This criterion will also tend to bias the prioritization of chemicals for which well-established analytical methods are available. Consequently, this criterion is not used in the initial prioritization scheme. However, within a particular priority grouping, reliable monitoring information should be considered for Second Tier rank ordering within a quantitative process that assesses if the data is above a level of concern (i.e., places it in a risk context). Use in Children's Products: Protection of childrens' health is a top priority and, in the initial ranking, child-specific products are captured under general consumer products and all consumer products are weighted equally. The specific IUR reporting of information on chemical use in products intended for children would be considered further within a particular priority grouping for Second Tier rank ordering, noting the following points: the IUR definition is based upon use in a child specific product rather than child specific exposure potential¹ (see below). Without knowing a specific product type, it is difficult to understand if 1 IUR definition (Federal Register Volume 75, Number 156, Friday August 30, 2010, p. 49686): Intended for use by children means the chemical substance or mixture is used in or on a product that is specifically intended for use by children age 14 or younger. A chemical substance or mixture is intended for use by children when the submitter answers "yes" to at least on of the following questions for the product into which the submitter's chemical substance or mixture is incorporated: (1) Is the product commonly recognized (i.e., by a reasonable person) as being intended for children age 14 or younger? (2) Does the manufacturer of the product state through product labeling or other written materials that the product is intended for or will be used by children age 14 or younger? (3) Is the advertising, promotion, or marketing of the product aimed at children age 14 or younger? August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 potential child exposure is greater than for a non-child specific product. For example, how does child exposure to a general use cleaner compare to exposure from use in a child's raincoat. In the VCCEP assessments, there are examples for inhalation exposures where estimates of passive child exposure during adult product use exceeded conservative estimates of child exposure during active use of a child-specific product (such as a hobby product) - differences were related to the amount of product used and substance concentration within the product (MEK VCCEP Submission). the IUR definition targets children age 14 and younger. Younger children may be exposed to a variety of non-child specific products that are in general household use. Older children may be exposed to a variety of additional products. the IUR information request is targeted to manufacturers, which may not have direct knowledge of all uses, particularly the presence in products for specific subpopulations, such as children. Therefore, it is not clear that the information requested for the IUR information would be consistently available across all substances being screened. Ideally, this information should be requested from formulators of child-specific products. Therefore, for the initial prioritization approach, which represents a broad, unrefined categorization, child specific products are captured under general consumer products and all consumer products are weighted equally. The IUR information on child specific use would be utilized within a particular priority grouping for Second Tier rank ordering. If the IUR information is utilized, it is important that the limitations above be considered in its application. Emissions Data: Production volume, which is readily available for substances, is used in this proposed approach, but only serves as a surrogate for environmental emissions. For further prioritization, data or estimates of environmental emissions can be used to refine prioritization. Estimates of environmental emissions will be available for some substances (e.g., TRI data). When TRI data are utilized it should be recognized that it addresses only emissions that result from industrial and not wide dispersive uses. In other cases, emissions estimates can be developed as a percentage of production volume based upon consideration of use categories. Within a particular priority grouping, available emissions information can be considered for Second Tier rank ordering, with the understanding that emissions information is not an indicator of actual exposure. Similarly, non-isolated system intermediates, by definition, would have de minimis exposure potential. Therefore, this IUR information could be considered within a particular priority grouping for Second Tier rank ordering. International Risk Management Actions: An initial screening approach for chemical prioritization should be based upon consistent application of specific hazard and exposure science elements that define risk potential. The hazard and exposure elements should be applicable across all substances being evaluated. For initial screening, existence of international risk management action plans should not be a factor that determines priority grouping. Risk management plans may be based upon many factors, including political drivers. It is unclear how factors, their relative weighting, and the rigor of the evaluation may vary across agencies and substances. For initial screening August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 purposes, the same science-based criteria should be used to rank all substances. Consideration of existing international risk management plans could be utilized to check the functioning of the approach and could be considered within a particular priority grouping for Second Tier rank ordering with the possible effect of moving a chemical up in a grouping if actions are being taken internationally. IV. Summary ACC's prioritization approach is an example of a risk-based screening prioritization process that implements the general principles outlined at the outset of this document. It is based upon widely available information that can be utilized to understand the relative priority of chemicals for further evaluation from a risk perspective, i.e., integrating both hazard and exposure elements. Implementation of the screening framework will be most effective when utilizing the best available information. When conducting screening for thousands of chemicals, EPA may not have access to all available information. An open and iterative process that includes an opportunity for review and comment on initial rankings, together with the information that led to the result, and an opportunity to update the ranking with improved information will create a transparent and scientifically sound process. V. References Arnot, J.A., D. Mackay, T. F. Parkerton, R. T. Zaleski, C.S. Warren (2010), Multimedia modeling of human exposure to chemical substances: The roles of food web biomagnification and biotransformation, Environmental Toxicology and Chemistry 29(1):45-55. Boethling, R., K. Fenner, P. Howard, G. Klecka, T. Madsen, J.R. Snape, M.J. Whelan (2009). Environmental persistence of organic pollutants: guidance for development and review of POP risk profiles. Integrated Environmental Assessment and Management 5(4): 539 - 556. Gobas, F.A.P.C, W. de Wolf, L. P Burkhard, E. Verbruggen, K. Plotzke (2009). Revisiting Bioaccumulation Criteria for POPs and PBT Assessments Integrated Environmental Assessment and Management, 5(4):624-637. MacLeod, M., T. E. McKone (2004). Multimedia persistence as an indicator of potential for population-level intake of environmental contaminants, Environmental Toxicology and Chemistry 23(10):2465-2472. van Wijk,D., R. Chénier, T. Henry, M. D Hernando, C. Schulte (2009). Integrated Approach to PBT and POP Prioritization and Risk Assessment' Integrated Environmental Assessment and Management, 5(4):697-711. August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 Proposed Prioritization Approach DRAFT May & 2011 Exposure Elements nat commental consumer 20 2 3 a 33 3 not 8 or Persuntence S not 3 mai 35 a & not 3 Pas $ 3 S the iss = the Tormages RUN $ 3 3 SUM - P8 - Tavamage ranow 3 -13 Expesure Ramking $5 Based os Sum (UN# + pa * Townage PRIORITY GROUPING - Hazard * Expasure Ramkings - 1-8 3-10 11-13 mad Jow Hazard - Highter and Human $ 3 3 & $ Human Mazard Not on Dase 3 low mai * anou % 1000 numour 3 1.8 (duet Nume " 3 & 3 8 Not 100 Acure mi os : 3 A 2000 and not data) 280 v 1000 (pas 1.0 8.0 nomour 8.3 miss Nome 3 & % x CMR Cat 2, on Dawe Call 3: 10 - 3 is # 200 50 ase Igas 0.3 1.0 0.0% - 0.2 mis forme * # $ y GMS CMR Can on OHS Clowe Clat % Repeat Close 10 § on 8 on insurticient 20 information to - - - 0.3 wis 0,00 mist on information to $ 3 a $ August 29, 2011 Source: :https://www.industrydocuments.ucsf.edu/docs/jzbn0226 Hazard and Exposure Criteria for Prioritization Approach HAZARD EXPOSURE Environment and Human Health Classifications based upon GHS Use Elements - based upon IUR Intermediate consumed during industrial processing Envirommental: industrial (not intermediate) - used in an industrial setting From GHS classification guidance document: commercial occupational use in nonindustrial setting Table 4.1.2: scheme for substances hazardous so the aquatic environment. consumer general population residential use Clacufication Persistence: Loag-term Votalile substance (VPS 1000 Pax: Not Persistent if air half life <2 days a (Nate 2) Nonvolatile (VP < 1000 Pa): Not Persistent if: Adequate dass Adequnte voriciny dasa aux a) ready biodegradability (OBCD 301) Rapidly 3 b) inherent biodegradability (OBCD 301, 302, 306) degredable 0) read across from measured data on a related substance. 28 (Note. 3) d) equivalent degree of degradation (i.e. >20% in 28 days) via an abjotic Arute 3 Categorys Chronic 1 Categury: 1 Categasy: I degradation mechanism such as photolysis (OBCD 316) or hydrolysis (OBCD NOEC ar ECA 0.1 NOE - EC cass L 1.00 md of maid 111) and/ar BCF a 200 OR, a substance is Not Persistent if: if e) evaluation of simulation data from transformation in soil, marine water/sediment, Caregusy: Acore 2 Category: Chronic 2 Caregury: Chrumin 2 Caregusy: Chruaic 2 brackish water/sediment, surface water/sediment, oceanic water die away (e.g., OECD 3.00 s: s 10.9 0.1 - NOEC er EC. 13 0.00 <: NOEC - EC, 502 3.00 L(EXC) 10.8 and of andies 308/309) have half lives below 180 days. BCF = 500 as if K. 2 4 OR, if data are lacking: Caregusy: Arnie 3 Caregury: 3 Chrinia 3 f) evaluation via BIOWIN model (EPIWEB 4) 01 EC. : 30,00 1- 100 and fack of Bioaccomulation: stapoid andier BOF: Re 300 if absent log x 3 4 A substance is not bioaccumulative if: 4 4) a) measured TMF < 1 (field study) 3) b) measured fish BMF <1 (lab study) Ne tericity and lack of and BCF 2 500 ase, lag E 4, c) measured fish BCF < 5000 (lab study) MOECA 1 mal d) predicted BCP< 5000 using the BCFBAF model included in EPIWIN 4 The above order reflects the preference for use in decision- making NOTE -- P&B CRITERIA ARB FOR ORGANICS Tonnage - based upon JUR reporting ranges <. 25,000 lbs (below IUR site reporting limit) Human Health: 25.000 - <1 MM lbs national aggregate As above, based upon GHS 1MM - <100 MM lbs national aggregate >100 MM lbs national aggregate August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 Risk-Based Prioritization Matrix Ancreasing Exposure Two-Step towest Prionies Prioritization Process Incregaling Second Tier Rank Ordering within Priority Groups Biomonitoring / Environmental Monitoring Use in Children's Products Emissions (e.g. TRI) International Risk Management Actions Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226

What is the heading of the first paragraph?

jzbn0226

jzbn0226_p24, jzbn0226_p25, jzbn0226_p26

E. Repopulation of High Priority Substances, Repopulation of High Priority Substances

C. Waivers EPA has proposed that all comments that could be raised on issues in a proposed low priority designation be presented during the comment period, and that any issues not raised then be considered to have been waived. Waived issues could not form the basis of an objection or challenge in any subsequent administrative or judicial proceeding on the designation of the substance as a low priority substance (which is subject to judicial review). EPA points to the statutory deadlines in the prioritization process as the policy justification for this proposal. 38 ACC urges EPA to remove this waiver requirement from the prioritization rule. First, it is inconsistent with Congress's intent that the prioritization process be iterative and science-based. Low priority designations should be able to be modified - expanded or contracted - based on new information that is brought to the Agency's attention after the designation. This new information might not have been known during the public comment period on the low priority designation. It would be bad public policy to consider new information waived because that could discourage stakeholders from gathering or developing relevant information about a chemical. Second, participation in the notice and comment rulemaking process of prioritization is governed by statute - through the Administrative Procedures Act (APA) and the judicial review provisions of Section 19 of TSCA. There are no issue exhaustion provisions in TSCA. EPA cannot by regulation, impose an issue exhaustion requirement that trumps the statutory rights and obligations of stakeholders under the APA and TSCA Section 19.39 D. Definitions As an addendum to ACC's recommendations for EPA to reference the Section 26 science standards in the prioritization process rule, ACC offers the following definitions for EPA's consideration: Best available science means information that has been evaluated based on its strengths, limitations and relevance and the Agency is relying on the highest quality information. In evaluating best available science the Agency will also consider the peer review of the science, whether the study was conducted in accordance with sound and objective practices, and if the data were collected by accepted methods or best available methods. To ensure transparency regarding best available science the Agency will describe and document any assumptions and methods used, and address variability, uncertainty, the degree of independent verification and peer review. Weight of the evidence means a systematic review method that uses a pre-established protocol to comprehensively, objectively, transparently, and consistently, identify and evaluate each stream of evidence, including strengths, limitations, and relevance of each study and to integrate evidence as necessary and appropriate based upon strengths, limitations, and relevance. 38 Id. at 4833. 39 See ACC Comments on EPA's Proposed Rule: Procedures for Chemical Risk Evaluation under the Amended Toxic Substances Control Act (RIN 2070- AK20) for additional discussion of the waiver/lock down/issue exhaustion issue. 23 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 E. Repopulation of High Priority Substances EPA's preamble discussion of the "repopulation" of high priority substances40 presents a reasonable approach by which the Agency could meet the LCSA obligation to finalize the designation of one new high priority substance upon completion of a risk evaluation for another substance. The one-for-one approach makes sense as this program gets underway. ACC suggests, however, that EPA consider a placeholder in its rule to anticipate changes in the rate at which EPA might be able to conduct risk evaluations over time (based on use of 21st Century tools and methods) and hence potentially change the rate at which EPA may need to designate high priorities for risk evaluation. VIII. Summary of ACC's Recommendations: Throughout these comments, ACC has included many specific recommendations for EPA to consider as it develops its final prioritization process rule to address ACC's concerns about the proposed rule. These recommendations urge EPA to direct its authority on what it is mandated to do under the LCSA - designate high priority and low priority chemicals for risk evaluations in accordance with both the criteria in LCSA Section 6 and the LCSA Section 26 science based standards. To help the regulated community provide EPA the information the Agency will need to prioritize chemicals for risk evaluations, EPA must clarify the prioritization process as a whole and develop an efficient and focused prioritization process rule that meets the LCSA mandate and Congressional intent. ACC strongly urges EPA to amend its proposal to include these suggested recommendations and seek public comment before finalizing the prioritization process rule. Alternatively, EPA should propose a supplemental rule providing more detail and clarifications on the prioritization process steps involved and finalize it prior to the Agency's first application of the prioritization process . To help foster the submission of information needed to prioritize chemicals for risk evaluations, EPA must ultimately develop an efficient and focused prioritization process rule that clearly lays out the major steps for meeting its mandate. 40 82 Fed. Reg. at 4833. 24 Source: :ttps://www.industrydocuments.ucsf.edu/docs/jzbn0226 Attachment A ACC's General Principles on Prioritization (Developed for EPA Dialogue 7-2011) EPA should systematically prioritize chemicals for purposes of safe use determinations. As a general matter, prioritization should be based on existing hazard and exposure data and information (including models, read across, QSAR, etc.) and industry should be responsible for providing EPA with this data and information. Chemicals lacking adequate hazard and exposure information should be considered a higher priority (until relevant information is provided that suggests otherwise). Industry should be provided an opportunity to provide EPA additional data/information. (Timing is an issue, however. And the format in which the information is provided to EPA must be useable/digestible by EPA, e.g. robust summaries.) Hazard, use and exposure based criteria should be integrated to form the basis for EPA's prioritization decisions. Prioritization should not be based on either hazard-only or exposure-only information. The prioritization process and science based criteria that EPA uses to prioritize chemicals must be transparent. Prioritization should be a dynamic, iterative process. Re-examination of priorities should occur as new information becomes available and as new chemicals are approved for manufacturing. For prioritization to be successful, it must include three critical elements: reliable and up- to- date chemical data and information; evaluation criteria that consider both hazard and exposure information together; and established cutoffs to make priority decisions. EPA's communication about priority chemicals must be clear about what the list is and what it is not, to avoid unintended consequences of product de-selection purely on the basis of listing. Transparency; consistent, scientific criteria; intersection of both hazard and exposure information; dynamic process so new information can be incorporated as it is made available and so if priorities are initially "wrong" they can be corrected. 25 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226

What is the first day mentioned?

npbn0226

npbn0226_p0, npbn0226_p1

MONDAY, MAY 1, 2017

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY (s) WASHINGTON, D.C. 20460 OFFICE OF ADMINISTRATION APR 26 2017 AND RESOURCES MANAGEMENT Nancy Beck Dear Ms. Beek: Congratulations You have been selected for an appointment with the U.S. Environmental Protection Agency (EPA). This is to officially inform you of your position as Deputy Assistant Administrator for Toxics. located in the Office of Chemical Safety and Pollution Prevention: Washington. DC. This position is an Excepted Service Administratively Determined (AD) position. Pursuant to the authority vested in the Administrator under Public Law 95-190, your compensation for this position has been set at $161.900 per annum. Your acceptance of this position means that: (1) your position is not in the competitive service; (2) you will serve at the pleasure of the Administrator: and (3) termination of your appointment may occur at anytime upon notice thereof. During a change in Administration, each position is generally reviewed on a case-by-case basis to determine if they meet the needs of the new Administration's goals and objectives for the Agency. Information About Your Position Your annual salary will be $161,900; Your immediate supervisor will be Wendy Cleland-Hamnett, Acting Assistant Administrator for Chemical Safety and Pollution Prevention; your second level supervisor will be E. Seott Pruitt. Administrator: You will work a full-time schedule: You will be subject to a pre-employment drug test. If your test results are not favorable. your appointment will be terminated: and Your position has been designated by our Personnel Security Office as a High Risk position. This designation will require your position to be subject to random drug testing procedures. The effective date of your appointment is April 30, 2017. We ask that you report for employee orientation on Monday, May 1, 2017 at 8:30 am. You will be met at the William Jefferson Clinton North guard station. When you arrive at the guard station. please call Charles Munoz on 203-564-3097 or Sharnett Willis on 202-564-7866. One of them will meet you at the guard's station in order to sign you into the building. You can reach the Agency by taking the Metro Commuter Rail. Board the Blue or Orange line train and get off at the Federal Triangle Metro Stop. Enter the U.S. Environmental Protection Agency William Jefferson Clinton North Building on your immediate right. internet Adoress (URL) * http://www.epa.gov Printed with Vegelabale oit Based trks on 100% Process Chiorne Free Recycled Paper Source: https://www.industrydocuments.ucsf.edu/docs/npbn0226 What to Bring on Your First Day Monday, May 1. 2017 You should go to the links below to access the forms. Please complete and bring the forms with you on Monday, May Lst. a. Optional Form 306, Declaration for Federal Employment n fill/of0306.pdf b. Standard Form 144, Statement of Prior Federal Service - c. Standard Form 256, Self-Identification of Disability - d. Standard Form 181, Ethnicity and Race Identification N e. Form 2231. FastStart Direct Deposit (need a voided check) - i` Tax form (federal) . Document(s) to establish your identity and employment eligibility (e.g., a current passport. certificate of U.S. citizenship, and/or a current copy of your driver's license) Social Security card issued by the Social Security Administration. Voided check (if you will be moving your direct deposit to another financial institution) If you are unable to produce the required document(s) you must produce a receipt showing that you have applied for the document(s). You will have three days to bring the original document(s) to your local Human Resources Office. Benefits As a non-temporary appointee, you are entitled to the same Federal Benefits package provided to General Schedule employees including: 10 paid Federal Holidays per year 13 days of sick leave each year based on the hours earned each pay period 13 10 26 days of vacation. depending on your years of employment based on the hours earned each pay period National recognized health insurance model that offers choice and flexibility along with substantial employer contributions to premiums. Employee share of premiums can be paid with pre-tax dollars: Source: https://www.industrydocuments.ucsf.edu/docs/npbn0226

In what case do they have to bring a Voided check?

npbn0226

npbn0226_p0, npbn0226_p1

if you will be moving your direct deposit to another financial institution

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY (s) WASHINGTON, D.C. 20460 OFFICE OF ADMINISTRATION APR 26 2017 AND RESOURCES MANAGEMENT Nancy Beck Dear Ms. Beek: Congratulations You have been selected for an appointment with the U.S. Environmental Protection Agency (EPA). This is to officially inform you of your position as Deputy Assistant Administrator for Toxics. located in the Office of Chemical Safety and Pollution Prevention: Washington. DC. This position is an Excepted Service Administratively Determined (AD) position. Pursuant to the authority vested in the Administrator under Public Law 95-190, your compensation for this position has been set at $161.900 per annum. Your acceptance of this position means that: (1) your position is not in the competitive service; (2) you will serve at the pleasure of the Administrator: and (3) termination of your appointment may occur at anytime upon notice thereof. During a change in Administration, each position is generally reviewed on a case-by-case basis to determine if they meet the needs of the new Administration's goals and objectives for the Agency. Information About Your Position Your annual salary will be $161,900; Your immediate supervisor will be Wendy Cleland-Hamnett, Acting Assistant Administrator for Chemical Safety and Pollution Prevention; your second level supervisor will be E. Seott Pruitt. Administrator: You will work a full-time schedule: You will be subject to a pre-employment drug test. If your test results are not favorable. your appointment will be terminated: and Your position has been designated by our Personnel Security Office as a High Risk position. This designation will require your position to be subject to random drug testing procedures. The effective date of your appointment is April 30, 2017. We ask that you report for employee orientation on Monday, May 1, 2017 at 8:30 am. You will be met at the William Jefferson Clinton North guard station. When you arrive at the guard station. please call Charles Munoz on 203-564-3097 or Sharnett Willis on 202-564-7866. One of them will meet you at the guard's station in order to sign you into the building. You can reach the Agency by taking the Metro Commuter Rail. Board the Blue or Orange line train and get off at the Federal Triangle Metro Stop. Enter the U.S. Environmental Protection Agency William Jefferson Clinton North Building on your immediate right. internet Adoress (URL) * http://www.epa.gov Printed with Vegelabale oit Based trks on 100% Process Chiorne Free Recycled Paper Source: https://www.industrydocuments.ucsf.edu/docs/npbn0226 What to Bring on Your First Day Monday, May 1. 2017 You should go to the links below to access the forms. Please complete and bring the forms with you on Monday, May Lst. a. Optional Form 306, Declaration for Federal Employment n fill/of0306.pdf b. Standard Form 144, Statement of Prior Federal Service - c. Standard Form 256, Self-Identification of Disability - d. Standard Form 181, Ethnicity and Race Identification N e. Form 2231. FastStart Direct Deposit (need a voided check) - i` Tax form (federal) . Document(s) to establish your identity and employment eligibility (e.g., a current passport. certificate of U.S. citizenship, and/or a current copy of your driver's license) Social Security card issued by the Social Security Administration. Voided check (if you will be moving your direct deposit to another financial institution) If you are unable to produce the required document(s) you must produce a receipt showing that you have applied for the document(s). You will have three days to bring the original document(s) to your local Human Resources Office. Benefits As a non-temporary appointee, you are entitled to the same Federal Benefits package provided to General Schedule employees including: 10 paid Federal Holidays per year 13 days of sick leave each year based on the hours earned each pay period 13 10 26 days of vacation. depending on your years of employment based on the hours earned each pay period National recognized health insurance model that offers choice and flexibility along with substantial employer contributions to premiums. Employee share of premiums can be paid with pre-tax dollars: Source: https://www.industrydocuments.ucsf.edu/docs/npbn0226

What is the first topic in table of contents?

jzbn0226

jzbn0226_p0, jzbn0226_p1, jzbn0226_p2, jzbn0226_p3, jzbn0226_p4, jzbn0226_p5, jzbn0226_p6, jzbn0226_p7, jzbn0226_p8

EXECUTIVE SUMMARY

American° Chemistry Council March 20, 2017 Docket Control Office (7407M) Office of Pollution Prevention and Toxics (OPPT) U.S. Environmental Protection Agency 1200 Pennsylvania Ave., NW Washington, DC 20460-0001 Sent electronically to www.regulations.gov Docket ID# EPA-HQ-OPPT-2016-0636 Re: ACC Comments on EPA's Proposed Procedures for Prioritization of Chemicals for Risk Evaluation under the Toxic Substances Control Act as amended by the Lautenberg Chemical Safety Act Dear Sir/Madam: The American Chemistry Council (ACC¹ appreciates the opportunity to provide written comments to the Office of Chemical Safety and Pollution Prevention to inform the Agency's development of a prioritization process rule under the Toxic Substances Control Act (TSCA), as amended by the Lautenberg Chemical Safety Act (LCSA). ACC is committed to being a constructive stakeholder in the effective implementation of the LCSA and we provide these comments to assist the Agency in its development of a chemical evaluation and management program that is efficient, science-based, and consistent with the legal requirements of the LCSA. Prioritization is the first step in the LCSA's framework for evaluating active chemicals in commerce and the prioritization process rule must establish a risk-based screening process and criteria to identify high and low priority substances for risk evaluations under the LCSA. If you have any questions, please contact me at: 202-249-6403 or Sarah [email protected] Sincerely, Saraht. Brance Sarah Brozena Senior Director, Regulatory & Technical Affairs Cc: Jeffrey Morris, Director, OPPT Wendy Cleland Hamnett, OCSPP Ryan Schmit, OCSPP 1 The American Chemistry Council (ACC) represents the leading companies engaged in the business of chemistry. ACC members apply the science of chemistry to make innovative products and services that make people's lives better, healthier and safer. ACC is committed to improved environmental, health and safety performance through Responsible CareR, common sense advocacy designed to address major public policy issues, and health and environmental research and product testing. The business of chemistry is a $797 billion enterprise and a key element of the nation's economy. It is one of the nation's largest exporters, accounting for ten cents out of every dollar in U.S. exports. Chemistry companies are among the largest investors in research and development. Safety and security have always been primary concerns of ACC members, and they have intensified their efforts, working closely with government agencies to improve security and to defend against any threat to the nation's critical infrastructure. americanchemistry.com" 700 Second St., NE I Washington, DC 20002 I (202) 249.7000 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 American Chemistry Council American Chemistry Council Comments on EPA's Proposed Procedures for Prioritization of Chemicals for Risk Evaluation under the Toxic Substances Control Act as amended by the Lautenberg Chemical Safety Act Docket ID# EPA-HQ-OPPT-2016-0636 March 20, 2017 Sarah Brozena Senior Director, Regulatory & Technical Affairs American Chemistry Council 700 2nd Street, NE Washington DC 2002 (202) 249-6403 Sarah [email protected] americanchemistry.com 700 Second St., NE I Washington, DC 20002 I (202)249.7000 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 Table of Contents EXECUTIVE SUMMARY 2 INTRODUCTION 4 I. ACC's Vision for a TSCA Prioritization Process Consistent with the LCSA 5 II. Overview of LCSA Prioritization Process Requirements 9 III. EPA Should Clarify Pre-Prioritization Step in Final Rule or Alternatively in Supplemental Rule 10 A. EPA Should Update Its TSCA Work Plan Criteria Before Using Them in Pre-Prioritization of Non-Work Plan Chemicals and Should Begin Planning to Integrate 21st Century Tools 11 B. EPA's Proposed Use of the Pre-Prioritization Step to Gather Information for Risk Evaluations Needs to Be Better Supported and Articulated 12 C. The Importance of Transparency in Prioritization Cannot Be Over-Emphasized 14 IV. EPA's Interpretation of Its Authority to Designate Low Priority Substances Is Short- Sighted, Contrary to Congressional Intent, Inconsistent with Best Available Science and Must Be Revised 15 A. EPA's Interpretation of Conditions of Use in the Prioritization Context Is a Strained Reading of the Statute and Contrary to Congressional Intent and Policy Objectives. 15 B. EPA's Abuse of Discretion Argument 16 C. EPA's Default to High Priority Designations Is Flawed Due to EPA's All Conditions of Use Interpretation. 17 D. Congress Authorized Ongoing Designations of Low Priority Chemicals 18 E. Best Available Risk-Based Scientific Procedures Enable EPA to Designate Low Priority Chemicals 18 V. Scientific Standards Must Be Referenced in the Prioritization Process Rule 19 A. Prioritization Decisions Must Be Based on Section 26 Standards for Best Available Science, Weight of the Scientific Evidence, and Transparency 19 B. EPA Should Address Other LCSA Science-Based Requirements in the Rule (Such As Tiered Testing and Animal Welfare Requirements). EPA Should Also Include a "Reserved" Placeholder in the Prioritization Rule for Incorporation of 21st Century Methods for Prioritization. 20 VI. Responses to EPA's Questions 20 A. Animal welfare requirements and scientific standards 20 B. EPA requests comments on its proposed process for prioritization overall. 21 C. Public input at pre-prioritization step 21 D. Consideration of substitutes in pre-prioritization 21 VII. Additional Specific Comments 22 A. Category of Chemical Substances 22 B. Inactive chemicals and new chemicals 22 C. Waivers 23 D. Definitions 23 E. Repopulation of High Priority Substances 24 VIII. Summary of ACC's Recommendations: 24 Attachment A 25 Attachment B 26 Attachment C 39 1 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 EXECUTIVE SUMMARY EPA has suggested four steps in its proposed rule to implement the prioritization requirements of Section 6(b) of the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act: "Pre-prioritization" to narrow the pool of potential candidate substances Initiation of the prioritization process by identifying candidate substances and soliciting public comment Proposed priority designation, including an opportunity for public comment Priority designation The American Chemistry Council (ACC) has three major concerns with EPA's proposed prioritization process rule. Our concerns relate to the proposed pre-prioritization step, the treatment of low priority designations, and EPA's failure to address the LCSA Section 26 science standards in the rule. ACC's comments include specific recommendations to address these concerns. EPA's proposed prioritization process hinges on the "pre-prioritization" step. EPA does not fully and clearly describe this step, its statutory authority or limitations. Pre-prioritization is not mentioned in TSCA section 6(b) as amended. EPA asserts that the statute leaves it "broad discretion" to choose which chemicals on the TSCA Inventory to put into the prioritization process. However, EPA must exercise its discretion in a reasonable manner and is required to describe the statutory authorities for its exercise of discretion. EPA has not done so here. EPA intends the pre-prioritization step to inform prioritization decisions and the risk evaluation process, without regard to other relevant provisions of the statute. Because EPA asserts that it may need additional time to gather or develop information for risk evaluations, it has proposed to use the pre-prioritization step to gather information on substances with "insufficient information" for risk evaluation. ACC acknowledges that the statute imposes time constraints on the Agency once the prioritization process is triggered, but we believe that EPA has other tools available to address information needs in both the prioritization and risk evaluation stages in a timely, efficient manner. For example, in its pre-prioritization step EPA does not address the important relevant testing requirements of Section 4(a)(2)(A) or (B), the statement of need requirements of Section 4(a)(3) or the tiered testing requirements of Section 4(a)(4). As proposed, the pre-prioritization step conflates the prioritization and risk evaluation processes in ways that are confusing to the regulated community. Importantly, the pre-prioritization step appears contrary to congressional intent. In prioritization, it is very important that all substances be treated consistently, by the same transparent criteria, and that the process is replicable. Other than noting the statutory obligation to designate as high priorities the Work Plan chemicals that meet certain "preference" criteria, the proposed rule does not define the criteria or tools by which EPA will choose Work Plan and other chemicals from the active TSCA Inventory for the pre-prioritization or candidate "pool." EPA did not seek any stakeholder input on this question. EPA has not explained how many chemicals it proposes to include in the pre-prioritization or prioritization pool, or whether and how it will 2 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 "batch" chemicals to move them forward into the "initiation of prioritization" step. Although EPA has identified the nine criteria by which it proposes to narrow the pool into a list of candidates for prioritization, EPA does not define the criteria and or discuss the methodology by which these criteria will be applied. EPA proposes no timeframe for the pre-prioritization step, and provides little guidance on the status of chemicals included in pre-prioritization but excluded from prioritization. EPA's treatment of low priority chemicals raises significant concerns. EPA's proposal to require that low priority designations be based upon "all" conditions of use is a gross misinterpretation of the statute. This flawed interpretation of EPA's authority will cause the Agency to designate most chemicals in commerce as high priorities, and the Agency states as much in the preamble to the proposed rule. Congress did not intend this result. Low priority designations were seen as one mechanism to enhance public confidence in the safety of a chemical substance under its conditions of use, short of a full risk assessment. EPA has continuing authority to revise priority designations at any time based on new information. EPA has failed to include the LCSA Section 26 science standards in the prioritization process rule itself. EPA continues to assert that, while relevant to prioritization, EPA is not obliged to include these standards in the rule. ACC respectfully but strongly disagrees with EPA's reasoning. ACC's comments include a series of recommendations to address the shortcomings of the proposed prioritization process rule. Our recommendations describe: A transparent process for pooling and batching active chemicals in commerce for prioritization screening. A process to gather available information needed to reach a decision. A "bridging" step to permit EPA to assess the sufficiency of information for anticipated priority designations of candidate chemicals, which will inform the risk evaluation scoping process (should it be necessary). Revisions that recognize EPA's discretion to designate a low priority substance based on one, some or all conditions of use Identification of science-based criteria, tools and standards that apply in the prioritization process. 3 Source: :ttps://www.industrydocuments.ucsf.edu/docs/jzbn0226 American Chemistry Council Comments to U.S. Environmental Protection Agency on Its Proposed Procedures for Prioritization of Chemicals for Risk Evaluation under the Toxic Substances Control Act INTRODUCTION The American Chemistry Council (ACC) is pleased to provide the U.S. Environmental Protection Agency (EPA) these comments on the Agency's proposed procedures for prioritization of chemicals for risk evaluation under the Toxic Substances Control Act (TSCA) as amended by the Lautenberg Chemical Safety Act (LCSA). The LCSA requires EPA to establish, by rule, a risk-based screening process to identify high and low priority substances for risk evaluations under the LCSA. ACC strongly supported Congress's efforts to update and reform TSCA. One of ACC's principles for modernizing TSCA called on EPA to systematically prioritize chemicals for purposes of risk evaluations. Without a scientifically based prioritization process, EPA would not be able to meet efficiently the other requirements of the LCSA and achieve the objectives of TSCA reform that Congress intended. As discussed in more detail below, EPA's proposed prioritization process falls short. Congress designed the LCSA to allow chemicals to be systematically prioritized and then to evaluate those substances presenting the greatest potential risk. This design is apparent in every part of the LCSA. It begins with a reclassification of the full catalog of chemistries in U.S. commerce, the TSCA Inventory. The LCSA requires that the TSCA Inventory be sorted, so that chemicals that are currently active in commerce are separated from those no longer manufactured, imported or used; only chemicals that are active in commerce are subject to the prioritization and risk evaluation. This enables EPA to focus resources for its multi-year, time-and-resource intensive risk evaluations on chemicals that are actually in current use. EPA must next undertake a prioritization process, to inform the sequence of chemicals that will undergo risk evaluation. EPA must then undertake a formal scoping process, to define the conditions of use (and potentially exposed sub-populations relevant to the use) that will be included in the scope of the risk evaluation of the chemical. Prioritization of chemicals for various purposes is not new to the Agency. In 2011, EPA held a Stakeholder Dialogue on Prioritization and established a Discussion Blog for additional input on the topic. In our comments to that discussion blog, ACC identified several general principles for prioritization (Attachment A). We believe these principles are reflected in the LCSA requirements, in particular the LCSA's recognition that prioritization is a risk based screening process that integrates information on both hazard and exposure potential. In 2011, ACC developed a two-step quantitative and qualitative tool to "proof test" our prioritization principles (Attachment B). We presented our principles and our prioritization tool to EPA in 2011, as well as to other industry and NGO stakeholders at the time. In 2012, EPA published its methodology to identify chemicals for its TSCA Work 4 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 Plan for Chemical Assessment (TSCA Work Plan) program. I. ACC's Vision for a TSCA Prioritization Process Consistent with the LCSA The LCSA requires EPA, by rule, to establish a risk-based screening process to designate chemicals as high or low priorities for risk evaluations. The LCSA includes criteria and considerations by which EPA must make these priority designations. To ensure EPA consistently has risk evaluations underway, the LCSA requires EPA to identify at least one new high priority for every risk evaluation that is completed. EPA's ability to designate additional priorities for 2 evaluation is limited only by the Agency's ability to complete risk evaluations in accordance with the deadlines established by Congress. Thus, Congress requires EPA to carefully choreograph the 3 identification of high priority substances for risk evaluations, in order to ensure that appropriate resources are available to complete the evaluations with the established deadlines. This implies a framework that efficiently coordinates EPA's prioritization process with EPA's risk evaluation process. ACC's vision for the prioritization process is one that enables EPA to meet all the requirements of the LCSA and congressional intent. Prioritization must be a risk based screening process in which EPA integrates hazard, use and exposure information to designate chemicals or categories of chemicals as either high or low priority for risk evaluations based on the criteria in Section 6. Information used to make prioritization decisions must be reasonably available; new information should be required through Section 4 tools only if EPA makes a determination pursuant to Section 4(a)(2)(B) that new information is necessary for prioritization. Prioritization designations must be based upon the science standards of LCSA Section 26, particularly best available science and weight of the scientific evidence. The basis for prioritization designations must be transparent and EPA's decisions must be communicated objectively and in neutral terms. ACC's vision of a prioritization process that meets these requirements includes six steps (see discussion below and the flowchart illustrating these steps on the next page and in Attachment C). ACC recommends that EPA clarify the needed timelines, criteria, tools, approaches and processes for these six steps, publish them for comment and include them in the final rule. Alternatively, EPA should propose these clarifications in a supplemental rule prior to the Agency's first application of the prioritization process. ACC's recommended six steps for the prioritization process are as follows: 1. Pool and Batch: EPA must "pool" active chemicals in commerce as candidates for designation as high or low priority for risk evaluation, based on transparent criteria/methods/approaches/tools and processes. EPA should then "batch" these candidates for information gathering. As EPA acknowledges in the "re-population" discussion of the preamble to the proposed rule4, the pace of EPA's completion of risk evaluations factors into the finalization of EPA's prioritization decisions. As a result, ACC expects that the number of candidates per "batch" for information gathering should be relatively small, at least in the early years of LCSA implementation. EPA's development of pools and batches should be subject to 2 15 U.S.C 1.2605(b)(3)(C) 3 15 U.S.C. 2605 (b)(2)(C) 4 82 Fed.Reg. 4825, 4833 (January 17, 2017). 5 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 estimated timeframes. 2. Information Gathering: Because Congress intended prioritization decisions to be based on reasonably available information, EPA should take a sequenced approach to information gathering on chemicals that EPA "batches" for prioritization. The sequenced steps should begin with EPA gathering reasonably available information about potential hazards, uses and potential exposure by relying upon sources such as read across/Quantitative Structure Activity Relationship (QSAR) information; Chemical Data Reporting (CDR) reports; EPA's CompTox Dashboard; High Production Volume (HPV) Challenge program; exposure information/models; EPA's Chemical Assessment and Management program (ChAMP); EPA's Voluntary Children's Chemical Evaluation Program (VCCEP); Canada's Chemical Management Program (CMP); OECD's eChemPortal; and robust study summaries developed under the EU's Registration, Evaluation, and Assessment of Chemicals (REACH). If this information is insufficient to designate the priority of a batched chemical, EPA should issue a notice in the Federal Register for voluntary call-ins of the type of information needed for prioritization and request discussions with manufacturers and processors of the chemicals. If voluntary information is still inadequate to prioritize, EPA should consider issuing TSCA Section 8(a) or 8(d) rules to require manufacturers/processors to collect existing information needed to prioritize. Finally, if EPA makes a determination subject to Section 4 requirements that new information is necessary to prioritize (and explaining why), EPA may issue Section 4 rules, orders or consent agreements. EPA should also be held accountable to using that information. The testing/exposure information EPA requires to be developed through Section 4 must be tiered. Finally, throughout the information gathering step, EPA should be asking whether it needs to "iterate" the information gathering process for prioritization, i.e., ask itself whether additional information should be gathered to designate a chemical as a high or low priority and if so to obtain it through the information gathering step process. 3. Sufficient Information to Designate: If EPA concludes it has sufficient information to designate the priority of a substance it can move that substance to the "Initiation of prioritization" step. If EPA concludes it has sufficient information to designate a substance as a high priority chemical, it should conduct a "pre-screening" review to identify potential data/information needs for scoping the risk evaluation (a bridging step between prioritization and scoping). If information on the chemical is deemed sufficient for scoping, the high priority chemical can then be put into the queue for "initiation" of the prioritization process at the appropriate time. If information is determined not sufficient for scoping, EPA should begin to collect/develop necessary information to scope the risk evaluation. This information screening "bridge" step should help EPA meet the 6-month statutory deadline for scoping a risk evaluation. However, this step would not replace either scoping itself or the anticipated need for EPA to collect other information during scoping. Further, it is not anticipated that this 6 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 step will develop all the information it will need for risk evaluation. EPA will not necessarily know what information it may need for risk evaluation until it actually conducts it. 4. Initiate the Priority Designation: EPA must announce a candidate for prioritization and request "relevant information" about that chemical and provide 90 days for persons to submit that information to EPA. The LCSA deadlines for priority setting (no less than 9 months; no more than 12 months) begin at this step. EPA will "pace" its priority designations to be ready when risk evaluations are near completion and ready to be replaced with a new priority. 5. Propose Priority Designation: EPA must propose a designation of a chemical as a high or low priority, including the basis for its proposal, and provide a 90 day public comment period. 6. Finalize the Designation of High Priority or Low Priority Chemical: EPA must finalize its designation of the chemical as either a high or low priority within the statutory deadlines (no less than 9 months; no more than 12 months). Low priority chemical designations are final agency action, subject to judicial review. EPA must communicate final designations of high priority chemicals very carefully to prevent the creation of "red-lists" of chemicals and other mis-interpretations by states or the marketplace. To help EPA understand ACC's vision of the prioritization process, we have attempted to capture a simplified version of it in the flowchart below. (See comments' text for more details.) 7 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226

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"ACCS Vision for a TSCA Prioritization Process Consistent with the LCSA"

American° Chemistry Council March 20, 2017 Docket Control Office (7407M) Office of Pollution Prevention and Toxics (OPPT) U.S. Environmental Protection Agency 1200 Pennsylvania Ave., NW Washington, DC 20460-0001 Sent electronically to www.regulations.gov Docket ID# EPA-HQ-OPPT-2016-0636 Re: ACC Comments on EPA's Proposed Procedures for Prioritization of Chemicals for Risk Evaluation under the Toxic Substances Control Act as amended by the Lautenberg Chemical Safety Act Dear Sir/Madam: The American Chemistry Council (ACC¹ appreciates the opportunity to provide written comments to the Office of Chemical Safety and Pollution Prevention to inform the Agency's development of a prioritization process rule under the Toxic Substances Control Act (TSCA), as amended by the Lautenberg Chemical Safety Act (LCSA). ACC is committed to being a constructive stakeholder in the effective implementation of the LCSA and we provide these comments to assist the Agency in its development of a chemical evaluation and management program that is efficient, science-based, and consistent with the legal requirements of the LCSA. Prioritization is the first step in the LCSA's framework for evaluating active chemicals in commerce and the prioritization process rule must establish a risk-based screening process and criteria to identify high and low priority substances for risk evaluations under the LCSA. If you have any questions, please contact me at: 202-249-6403 or Sarah [email protected] Sincerely, Saraht. Brance Sarah Brozena Senior Director, Regulatory & Technical Affairs Cc: Jeffrey Morris, Director, OPPT Wendy Cleland Hamnett, OCSPP Ryan Schmit, OCSPP 1 The American Chemistry Council (ACC) represents the leading companies engaged in the business of chemistry. ACC members apply the science of chemistry to make innovative products and services that make people's lives better, healthier and safer. ACC is committed to improved environmental, health and safety performance through Responsible CareR, common sense advocacy designed to address major public policy issues, and health and environmental research and product testing. The business of chemistry is a $797 billion enterprise and a key element of the nation's economy. It is one of the nation's largest exporters, accounting for ten cents out of every dollar in U.S. exports. Chemistry companies are among the largest investors in research and development. Safety and security have always been primary concerns of ACC members, and they have intensified their efforts, working closely with government agencies to improve security and to defend against any threat to the nation's critical infrastructure. americanchemistry.com" 700 Second St., NE I Washington, DC 20002 I (202) 249.7000 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 American Chemistry Council American Chemistry Council Comments on EPA's Proposed Procedures for Prioritization of Chemicals for Risk Evaluation under the Toxic Substances Control Act as amended by the Lautenberg Chemical Safety Act Docket ID# EPA-HQ-OPPT-2016-0636 March 20, 2017 Sarah Brozena Senior Director, Regulatory & Technical Affairs American Chemistry Council 700 2nd Street, NE Washington DC 2002 (202) 249-6403 Sarah [email protected] americanchemistry.com 700 Second St., NE I Washington, DC 20002 I (202)249.7000 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 Table of Contents EXECUTIVE SUMMARY 2 INTRODUCTION 4 I. ACC's Vision for a TSCA Prioritization Process Consistent with the LCSA 5 II. Overview of LCSA Prioritization Process Requirements 9 III. EPA Should Clarify Pre-Prioritization Step in Final Rule or Alternatively in Supplemental Rule 10 A. EPA Should Update Its TSCA Work Plan Criteria Before Using Them in Pre-Prioritization of Non-Work Plan Chemicals and Should Begin Planning to Integrate 21st Century Tools 11 B. EPA's Proposed Use of the Pre-Prioritization Step to Gather Information for Risk Evaluations Needs to Be Better Supported and Articulated 12 C. The Importance of Transparency in Prioritization Cannot Be Over-Emphasized 14 IV. EPA's Interpretation of Its Authority to Designate Low Priority Substances Is Short- Sighted, Contrary to Congressional Intent, Inconsistent with Best Available Science and Must Be Revised 15 A. EPA's Interpretation of Conditions of Use in the Prioritization Context Is a Strained Reading of the Statute and Contrary to Congressional Intent and Policy Objectives. 15 B. EPA's Abuse of Discretion Argument 16 C. EPA's Default to High Priority Designations Is Flawed Due to EPA's All Conditions of Use Interpretation. 17 D. Congress Authorized Ongoing Designations of Low Priority Chemicals 18 E. Best Available Risk-Based Scientific Procedures Enable EPA to Designate Low Priority Chemicals 18 V. Scientific Standards Must Be Referenced in the Prioritization Process Rule 19 A. Prioritization Decisions Must Be Based on Section 26 Standards for Best Available Science, Weight of the Scientific Evidence, and Transparency 19 B. EPA Should Address Other LCSA Science-Based Requirements in the Rule (Such As Tiered Testing and Animal Welfare Requirements). EPA Should Also Include a "Reserved" Placeholder in the Prioritization Rule for Incorporation of 21st Century Methods for Prioritization. 20 VI. Responses to EPA's Questions 20 A. Animal welfare requirements and scientific standards 20 B. EPA requests comments on its proposed process for prioritization overall. 21 C. Public input at pre-prioritization step 21 D. Consideration of substitutes in pre-prioritization 21 VII. Additional Specific Comments 22 A. Category of Chemical Substances 22 B. Inactive chemicals and new chemicals 22 C. Waivers 23 D. Definitions 23 E. Repopulation of High Priority Substances 24 VIII. Summary of ACC's Recommendations: 24 Attachment A 25 Attachment B 26 Attachment C 39 1 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 EXECUTIVE SUMMARY EPA has suggested four steps in its proposed rule to implement the prioritization requirements of Section 6(b) of the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act: "Pre-prioritization" to narrow the pool of potential candidate substances Initiation of the prioritization process by identifying candidate substances and soliciting public comment Proposed priority designation, including an opportunity for public comment Priority designation The American Chemistry Council (ACC) has three major concerns with EPA's proposed prioritization process rule. Our concerns relate to the proposed pre-prioritization step, the treatment of low priority designations, and EPA's failure to address the LCSA Section 26 science standards in the rule. ACC's comments include specific recommendations to address these concerns. EPA's proposed prioritization process hinges on the "pre-prioritization" step. EPA does not fully and clearly describe this step, its statutory authority or limitations. Pre-prioritization is not mentioned in TSCA section 6(b) as amended. EPA asserts that the statute leaves it "broad discretion" to choose which chemicals on the TSCA Inventory to put into the prioritization process. However, EPA must exercise its discretion in a reasonable manner and is required to describe the statutory authorities for its exercise of discretion. EPA has not done so here. EPA intends the pre-prioritization step to inform prioritization decisions and the risk evaluation process, without regard to other relevant provisions of the statute. Because EPA asserts that it may need additional time to gather or develop information for risk evaluations, it has proposed to use the pre-prioritization step to gather information on substances with "insufficient information" for risk evaluation. ACC acknowledges that the statute imposes time constraints on the Agency once the prioritization process is triggered, but we believe that EPA has other tools available to address information needs in both the prioritization and risk evaluation stages in a timely, efficient manner. For example, in its pre-prioritization step EPA does not address the important relevant testing requirements of Section 4(a)(2)(A) or (B), the statement of need requirements of Section 4(a)(3) or the tiered testing requirements of Section 4(a)(4). As proposed, the pre-prioritization step conflates the prioritization and risk evaluation processes in ways that are confusing to the regulated community. Importantly, the pre-prioritization step appears contrary to congressional intent. In prioritization, it is very important that all substances be treated consistently, by the same transparent criteria, and that the process is replicable. Other than noting the statutory obligation to designate as high priorities the Work Plan chemicals that meet certain "preference" criteria, the proposed rule does not define the criteria or tools by which EPA will choose Work Plan and other chemicals from the active TSCA Inventory for the pre-prioritization or candidate "pool." EPA did not seek any stakeholder input on this question. EPA has not explained how many chemicals it proposes to include in the pre-prioritization or prioritization pool, or whether and how it will 2 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 "batch" chemicals to move them forward into the "initiation of prioritization" step. Although EPA has identified the nine criteria by which it proposes to narrow the pool into a list of candidates for prioritization, EPA does not define the criteria and or discuss the methodology by which these criteria will be applied. EPA proposes no timeframe for the pre-prioritization step, and provides little guidance on the status of chemicals included in pre-prioritization but excluded from prioritization. EPA's treatment of low priority chemicals raises significant concerns. EPA's proposal to require that low priority designations be based upon "all" conditions of use is a gross misinterpretation of the statute. This flawed interpretation of EPA's authority will cause the Agency to designate most chemicals in commerce as high priorities, and the Agency states as much in the preamble to the proposed rule. Congress did not intend this result. Low priority designations were seen as one mechanism to enhance public confidence in the safety of a chemical substance under its conditions of use, short of a full risk assessment. EPA has continuing authority to revise priority designations at any time based on new information. EPA has failed to include the LCSA Section 26 science standards in the prioritization process rule itself. EPA continues to assert that, while relevant to prioritization, EPA is not obliged to include these standards in the rule. ACC respectfully but strongly disagrees with EPA's reasoning. ACC's comments include a series of recommendations to address the shortcomings of the proposed prioritization process rule. Our recommendations describe: A transparent process for pooling and batching active chemicals in commerce for prioritization screening. A process to gather available information needed to reach a decision. A "bridging" step to permit EPA to assess the sufficiency of information for anticipated priority designations of candidate chemicals, which will inform the risk evaluation scoping process (should it be necessary). Revisions that recognize EPA's discretion to designate a low priority substance based on one, some or all conditions of use Identification of science-based criteria, tools and standards that apply in the prioritization process. 3 Source: :ttps://www.industrydocuments.ucsf.edu/docs/jzbn0226 American Chemistry Council Comments to U.S. Environmental Protection Agency on Its Proposed Procedures for Prioritization of Chemicals for Risk Evaluation under the Toxic Substances Control Act INTRODUCTION The American Chemistry Council (ACC) is pleased to provide the U.S. Environmental Protection Agency (EPA) these comments on the Agency's proposed procedures for prioritization of chemicals for risk evaluation under the Toxic Substances Control Act (TSCA) as amended by the Lautenberg Chemical Safety Act (LCSA). The LCSA requires EPA to establish, by rule, a risk-based screening process to identify high and low priority substances for risk evaluations under the LCSA. ACC strongly supported Congress's efforts to update and reform TSCA. One of ACC's principles for modernizing TSCA called on EPA to systematically prioritize chemicals for purposes of risk evaluations. Without a scientifically based prioritization process, EPA would not be able to meet efficiently the other requirements of the LCSA and achieve the objectives of TSCA reform that Congress intended. As discussed in more detail below, EPA's proposed prioritization process falls short. Congress designed the LCSA to allow chemicals to be systematically prioritized and then to evaluate those substances presenting the greatest potential risk. This design is apparent in every part of the LCSA. It begins with a reclassification of the full catalog of chemistries in U.S. commerce, the TSCA Inventory. The LCSA requires that the TSCA Inventory be sorted, so that chemicals that are currently active in commerce are separated from those no longer manufactured, imported or used; only chemicals that are active in commerce are subject to the prioritization and risk evaluation. This enables EPA to focus resources for its multi-year, time-and-resource intensive risk evaluations on chemicals that are actually in current use. EPA must next undertake a prioritization process, to inform the sequence of chemicals that will undergo risk evaluation. EPA must then undertake a formal scoping process, to define the conditions of use (and potentially exposed sub-populations relevant to the use) that will be included in the scope of the risk evaluation of the chemical. Prioritization of chemicals for various purposes is not new to the Agency. In 2011, EPA held a Stakeholder Dialogue on Prioritization and established a Discussion Blog for additional input on the topic. In our comments to that discussion blog, ACC identified several general principles for prioritization (Attachment A). We believe these principles are reflected in the LCSA requirements, in particular the LCSA's recognition that prioritization is a risk based screening process that integrates information on both hazard and exposure potential. In 2011, ACC developed a two-step quantitative and qualitative tool to "proof test" our prioritization principles (Attachment B). We presented our principles and our prioritization tool to EPA in 2011, as well as to other industry and NGO stakeholders at the time. In 2012, EPA published its methodology to identify chemicals for its TSCA Work 4 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 Plan for Chemical Assessment (TSCA Work Plan) program. I. ACC's Vision for a TSCA Prioritization Process Consistent with the LCSA The LCSA requires EPA, by rule, to establish a risk-based screening process to designate chemicals as high or low priorities for risk evaluations. The LCSA includes criteria and considerations by which EPA must make these priority designations. To ensure EPA consistently has risk evaluations underway, the LCSA requires EPA to identify at least one new high priority for every risk evaluation that is completed. EPA's ability to designate additional priorities for 2 evaluation is limited only by the Agency's ability to complete risk evaluations in accordance with the deadlines established by Congress. Thus, Congress requires EPA to carefully choreograph the 3 identification of high priority substances for risk evaluations, in order to ensure that appropriate resources are available to complete the evaluations with the established deadlines. This implies a framework that efficiently coordinates EPA's prioritization process with EPA's risk evaluation process. ACC's vision for the prioritization process is one that enables EPA to meet all the requirements of the LCSA and congressional intent. Prioritization must be a risk based screening process in which EPA integrates hazard, use and exposure information to designate chemicals or categories of chemicals as either high or low priority for risk evaluations based on the criteria in Section 6. Information used to make prioritization decisions must be reasonably available; new information should be required through Section 4 tools only if EPA makes a determination pursuant to Section 4(a)(2)(B) that new information is necessary for prioritization. Prioritization designations must be based upon the science standards of LCSA Section 26, particularly best available science and weight of the scientific evidence. The basis for prioritization designations must be transparent and EPA's decisions must be communicated objectively and in neutral terms. ACC's vision of a prioritization process that meets these requirements includes six steps (see discussion below and the flowchart illustrating these steps on the next page and in Attachment C). ACC recommends that EPA clarify the needed timelines, criteria, tools, approaches and processes for these six steps, publish them for comment and include them in the final rule. Alternatively, EPA should propose these clarifications in a supplemental rule prior to the Agency's first application of the prioritization process. ACC's recommended six steps for the prioritization process are as follows: 1. Pool and Batch: EPA must "pool" active chemicals in commerce as candidates for designation as high or low priority for risk evaluation, based on transparent criteria/methods/approaches/tools and processes. EPA should then "batch" these candidates for information gathering. As EPA acknowledges in the "re-population" discussion of the preamble to the proposed rule4, the pace of EPA's completion of risk evaluations factors into the finalization of EPA's prioritization decisions. As a result, ACC expects that the number of candidates per "batch" for information gathering should be relatively small, at least in the early years of LCSA implementation. EPA's development of pools and batches should be subject to 2 15 U.S.C 1.2605(b)(3)(C) 3 15 U.S.C. 2605 (b)(2)(C) 4 82 Fed.Reg. 4825, 4833 (January 17, 2017). 5 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 estimated timeframes. 2. Information Gathering: Because Congress intended prioritization decisions to be based on reasonably available information, EPA should take a sequenced approach to information gathering on chemicals that EPA "batches" for prioritization. The sequenced steps should begin with EPA gathering reasonably available information about potential hazards, uses and potential exposure by relying upon sources such as read across/Quantitative Structure Activity Relationship (QSAR) information; Chemical Data Reporting (CDR) reports; EPA's CompTox Dashboard; High Production Volume (HPV) Challenge program; exposure information/models; EPA's Chemical Assessment and Management program (ChAMP); EPA's Voluntary Children's Chemical Evaluation Program (VCCEP); Canada's Chemical Management Program (CMP); OECD's eChemPortal; and robust study summaries developed under the EU's Registration, Evaluation, and Assessment of Chemicals (REACH). If this information is insufficient to designate the priority of a batched chemical, EPA should issue a notice in the Federal Register for voluntary call-ins of the type of information needed for prioritization and request discussions with manufacturers and processors of the chemicals. If voluntary information is still inadequate to prioritize, EPA should consider issuing TSCA Section 8(a) or 8(d) rules to require manufacturers/processors to collect existing information needed to prioritize. Finally, if EPA makes a determination subject to Section 4 requirements that new information is necessary to prioritize (and explaining why), EPA may issue Section 4 rules, orders or consent agreements. EPA should also be held accountable to using that information. The testing/exposure information EPA requires to be developed through Section 4 must be tiered. Finally, throughout the information gathering step, EPA should be asking whether it needs to "iterate" the information gathering process for prioritization, i.e., ask itself whether additional information should be gathered to designate a chemical as a high or low priority and if so to obtain it through the information gathering step process. 3. Sufficient Information to Designate: If EPA concludes it has sufficient information to designate the priority of a substance it can move that substance to the "Initiation of prioritization" step. If EPA concludes it has sufficient information to designate a substance as a high priority chemical, it should conduct a "pre-screening" review to identify potential data/information needs for scoping the risk evaluation (a bridging step between prioritization and scoping). If information on the chemical is deemed sufficient for scoping, the high priority chemical can then be put into the queue for "initiation" of the prioritization process at the appropriate time. If information is determined not sufficient for scoping, EPA should begin to collect/develop necessary information to scope the risk evaluation. This information screening "bridge" step should help EPA meet the 6-month statutory deadline for scoping a risk evaluation. However, this step would not replace either scoping itself or the anticipated need for EPA to collect other information during scoping. Further, it is not anticipated that this 6 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 step will develop all the information it will need for risk evaluation. EPA will not necessarily know what information it may need for risk evaluation until it actually conducts it. 4. Initiate the Priority Designation: EPA must announce a candidate for prioritization and request "relevant information" about that chemical and provide 90 days for persons to submit that information to EPA. The LCSA deadlines for priority setting (no less than 9 months; no more than 12 months) begin at this step. EPA will "pace" its priority designations to be ready when risk evaluations are near completion and ready to be replaced with a new priority. 5. Propose Priority Designation: EPA must propose a designation of a chemical as a high or low priority, including the basis for its proposal, and provide a 90 day public comment period. 6. Finalize the Designation of High Priority or Low Priority Chemical: EPA must finalize its designation of the chemical as either a high or low priority within the statutory deadlines (no less than 9 months; no more than 12 months). Low priority chemical designations are final agency action, subject to judicial review. EPA must communicate final designations of high priority chemicals very carefully to prevent the creation of "red-lists" of chemicals and other mis-interpretations by states or the marketplace. To help EPA understand ACC's vision of the prioritization process, we have attempted to capture a simplified version of it in the flowchart below. (See comments' text for more details.) 7 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226

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American° Chemistry Council March 20, 2017 Docket Control Office (7407M) Office of Pollution Prevention and Toxics (OPPT) U.S. Environmental Protection Agency 1200 Pennsylvania Ave., NW Washington, DC 20460-0001 Sent electronically to www.regulations.gov Docket ID# EPA-HQ-OPPT-2016-0636 Re: ACC Comments on EPA's Proposed Procedures for Prioritization of Chemicals for Risk Evaluation under the Toxic Substances Control Act as amended by the Lautenberg Chemical Safety Act Dear Sir/Madam: The American Chemistry Council (ACC¹ appreciates the opportunity to provide written comments to the Office of Chemical Safety and Pollution Prevention to inform the Agency's development of a prioritization process rule under the Toxic Substances Control Act (TSCA), as amended by the Lautenberg Chemical Safety Act (LCSA). ACC is committed to being a constructive stakeholder in the effective implementation of the LCSA and we provide these comments to assist the Agency in its development of a chemical evaluation and management program that is efficient, science-based, and consistent with the legal requirements of the LCSA. Prioritization is the first step in the LCSA's framework for evaluating active chemicals in commerce and the prioritization process rule must establish a risk-based screening process and criteria to identify high and low priority substances for risk evaluations under the LCSA. If you have any questions, please contact me at: 202-249-6403 or Sarah [email protected] Sincerely, Saraht. Brance Sarah Brozena Senior Director, Regulatory & Technical Affairs Cc: Jeffrey Morris, Director, OPPT Wendy Cleland Hamnett, OCSPP Ryan Schmit, OCSPP 1 The American Chemistry Council (ACC) represents the leading companies engaged in the business of chemistry. ACC members apply the science of chemistry to make innovative products and services that make people's lives better, healthier and safer. ACC is committed to improved environmental, health and safety performance through Responsible CareR, common sense advocacy designed to address major public policy issues, and health and environmental research and product testing. The business of chemistry is a $797 billion enterprise and a key element of the nation's economy. It is one of the nation's largest exporters, accounting for ten cents out of every dollar in U.S. exports. Chemistry companies are among the largest investors in research and development. Safety and security have always been primary concerns of ACC members, and they have intensified their efforts, working closely with government agencies to improve security and to defend against any threat to the nation's critical infrastructure. americanchemistry.com" 700 Second St., NE I Washington, DC 20002 I (202) 249.7000 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 American Chemistry Council American Chemistry Council Comments on EPA's Proposed Procedures for Prioritization of Chemicals for Risk Evaluation under the Toxic Substances Control Act as amended by the Lautenberg Chemical Safety Act Docket ID# EPA-HQ-OPPT-2016-0636 March 20, 2017 Sarah Brozena Senior Director, Regulatory & Technical Affairs American Chemistry Council 700 2nd Street, NE Washington DC 2002 (202) 249-6403 Sarah [email protected] americanchemistry.com 700 Second St., NE I Washington, DC 20002 I (202)249.7000 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 Table of Contents EXECUTIVE SUMMARY 2 INTRODUCTION 4 I. ACC's Vision for a TSCA Prioritization Process Consistent with the LCSA 5 II. Overview of LCSA Prioritization Process Requirements 9 III. EPA Should Clarify Pre-Prioritization Step in Final Rule or Alternatively in Supplemental Rule 10 A. EPA Should Update Its TSCA Work Plan Criteria Before Using Them in Pre-Prioritization of Non-Work Plan Chemicals and Should Begin Planning to Integrate 21st Century Tools 11 B. EPA's Proposed Use of the Pre-Prioritization Step to Gather Information for Risk Evaluations Needs to Be Better Supported and Articulated 12 C. The Importance of Transparency in Prioritization Cannot Be Over-Emphasized 14 IV. EPA's Interpretation of Its Authority to Designate Low Priority Substances Is Short- Sighted, Contrary to Congressional Intent, Inconsistent with Best Available Science and Must Be Revised 15 A. EPA's Interpretation of Conditions of Use in the Prioritization Context Is a Strained Reading of the Statute and Contrary to Congressional Intent and Policy Objectives. 15 B. EPA's Abuse of Discretion Argument 16 C. EPA's Default to High Priority Designations Is Flawed Due to EPA's All Conditions of Use Interpretation. 17 D. Congress Authorized Ongoing Designations of Low Priority Chemicals 18 E. Best Available Risk-Based Scientific Procedures Enable EPA to Designate Low Priority Chemicals 18 V. Scientific Standards Must Be Referenced in the Prioritization Process Rule 19 A. Prioritization Decisions Must Be Based on Section 26 Standards for Best Available Science, Weight of the Scientific Evidence, and Transparency 19 B. EPA Should Address Other LCSA Science-Based Requirements in the Rule (Such As Tiered Testing and Animal Welfare Requirements). EPA Should Also Include a "Reserved" Placeholder in the Prioritization Rule for Incorporation of 21st Century Methods for Prioritization. 20 VI. Responses to EPA's Questions 20 A. Animal welfare requirements and scientific standards 20 B. EPA requests comments on its proposed process for prioritization overall. 21 C. Public input at pre-prioritization step 21 D. Consideration of substitutes in pre-prioritization 21 VII. Additional Specific Comments 22 A. Category of Chemical Substances 22 B. Inactive chemicals and new chemicals 22 C. Waivers 23 D. Definitions 23 E. Repopulation of High Priority Substances 24 VIII. Summary of ACC's Recommendations: 24 Attachment A 25 Attachment B 26 Attachment C 39 1 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 EXECUTIVE SUMMARY EPA has suggested four steps in its proposed rule to implement the prioritization requirements of Section 6(b) of the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act: "Pre-prioritization" to narrow the pool of potential candidate substances Initiation of the prioritization process by identifying candidate substances and soliciting public comment Proposed priority designation, including an opportunity for public comment Priority designation The American Chemistry Council (ACC) has three major concerns with EPA's proposed prioritization process rule. Our concerns relate to the proposed pre-prioritization step, the treatment of low priority designations, and EPA's failure to address the LCSA Section 26 science standards in the rule. ACC's comments include specific recommendations to address these concerns. EPA's proposed prioritization process hinges on the "pre-prioritization" step. EPA does not fully and clearly describe this step, its statutory authority or limitations. Pre-prioritization is not mentioned in TSCA section 6(b) as amended. EPA asserts that the statute leaves it "broad discretion" to choose which chemicals on the TSCA Inventory to put into the prioritization process. However, EPA must exercise its discretion in a reasonable manner and is required to describe the statutory authorities for its exercise of discretion. EPA has not done so here. EPA intends the pre-prioritization step to inform prioritization decisions and the risk evaluation process, without regard to other relevant provisions of the statute. Because EPA asserts that it may need additional time to gather or develop information for risk evaluations, it has proposed to use the pre-prioritization step to gather information on substances with "insufficient information" for risk evaluation. ACC acknowledges that the statute imposes time constraints on the Agency once the prioritization process is triggered, but we believe that EPA has other tools available to address information needs in both the prioritization and risk evaluation stages in a timely, efficient manner. For example, in its pre-prioritization step EPA does not address the important relevant testing requirements of Section 4(a)(2)(A) or (B), the statement of need requirements of Section 4(a)(3) or the tiered testing requirements of Section 4(a)(4). As proposed, the pre-prioritization step conflates the prioritization and risk evaluation processes in ways that are confusing to the regulated community. Importantly, the pre-prioritization step appears contrary to congressional intent. In prioritization, it is very important that all substances be treated consistently, by the same transparent criteria, and that the process is replicable. Other than noting the statutory obligation to designate as high priorities the Work Plan chemicals that meet certain "preference" criteria, the proposed rule does not define the criteria or tools by which EPA will choose Work Plan and other chemicals from the active TSCA Inventory for the pre-prioritization or candidate "pool." EPA did not seek any stakeholder input on this question. EPA has not explained how many chemicals it proposes to include in the pre-prioritization or prioritization pool, or whether and how it will 2 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 "batch" chemicals to move them forward into the "initiation of prioritization" step. Although EPA has identified the nine criteria by which it proposes to narrow the pool into a list of candidates for prioritization, EPA does not define the criteria and or discuss the methodology by which these criteria will be applied. EPA proposes no timeframe for the pre-prioritization step, and provides little guidance on the status of chemicals included in pre-prioritization but excluded from prioritization. EPA's treatment of low priority chemicals raises significant concerns. EPA's proposal to require that low priority designations be based upon "all" conditions of use is a gross misinterpretation of the statute. This flawed interpretation of EPA's authority will cause the Agency to designate most chemicals in commerce as high priorities, and the Agency states as much in the preamble to the proposed rule. Congress did not intend this result. Low priority designations were seen as one mechanism to enhance public confidence in the safety of a chemical substance under its conditions of use, short of a full risk assessment. EPA has continuing authority to revise priority designations at any time based on new information. EPA has failed to include the LCSA Section 26 science standards in the prioritization process rule itself. EPA continues to assert that, while relevant to prioritization, EPA is not obliged to include these standards in the rule. ACC respectfully but strongly disagrees with EPA's reasoning. ACC's comments include a series of recommendations to address the shortcomings of the proposed prioritization process rule. Our recommendations describe: A transparent process for pooling and batching active chemicals in commerce for prioritization screening. A process to gather available information needed to reach a decision. A "bridging" step to permit EPA to assess the sufficiency of information for anticipated priority designations of candidate chemicals, which will inform the risk evaluation scoping process (should it be necessary). Revisions that recognize EPA's discretion to designate a low priority substance based on one, some or all conditions of use Identification of science-based criteria, tools and standards that apply in the prioritization process. 3 Source: :ttps://www.industrydocuments.ucsf.edu/docs/jzbn0226 American Chemistry Council Comments to U.S. Environmental Protection Agency on Its Proposed Procedures for Prioritization of Chemicals for Risk Evaluation under the Toxic Substances Control Act INTRODUCTION The American Chemistry Council (ACC) is pleased to provide the U.S. Environmental Protection Agency (EPA) these comments on the Agency's proposed procedures for prioritization of chemicals for risk evaluation under the Toxic Substances Control Act (TSCA) as amended by the Lautenberg Chemical Safety Act (LCSA). The LCSA requires EPA to establish, by rule, a risk-based screening process to identify high and low priority substances for risk evaluations under the LCSA. ACC strongly supported Congress's efforts to update and reform TSCA. One of ACC's principles for modernizing TSCA called on EPA to systematically prioritize chemicals for purposes of risk evaluations. Without a scientifically based prioritization process, EPA would not be able to meet efficiently the other requirements of the LCSA and achieve the objectives of TSCA reform that Congress intended. As discussed in more detail below, EPA's proposed prioritization process falls short. Congress designed the LCSA to allow chemicals to be systematically prioritized and then to evaluate those substances presenting the greatest potential risk. This design is apparent in every part of the LCSA. It begins with a reclassification of the full catalog of chemistries in U.S. commerce, the TSCA Inventory. The LCSA requires that the TSCA Inventory be sorted, so that chemicals that are currently active in commerce are separated from those no longer manufactured, imported or used; only chemicals that are active in commerce are subject to the prioritization and risk evaluation. This enables EPA to focus resources for its multi-year, time-and-resource intensive risk evaluations on chemicals that are actually in current use. EPA must next undertake a prioritization process, to inform the sequence of chemicals that will undergo risk evaluation. EPA must then undertake a formal scoping process, to define the conditions of use (and potentially exposed sub-populations relevant to the use) that will be included in the scope of the risk evaluation of the chemical. Prioritization of chemicals for various purposes is not new to the Agency. In 2011, EPA held a Stakeholder Dialogue on Prioritization and established a Discussion Blog for additional input on the topic. In our comments to that discussion blog, ACC identified several general principles for prioritization (Attachment A). We believe these principles are reflected in the LCSA requirements, in particular the LCSA's recognition that prioritization is a risk based screening process that integrates information on both hazard and exposure potential. In 2011, ACC developed a two-step quantitative and qualitative tool to "proof test" our prioritization principles (Attachment B). We presented our principles and our prioritization tool to EPA in 2011, as well as to other industry and NGO stakeholders at the time. In 2012, EPA published its methodology to identify chemicals for its TSCA Work 4 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 Plan for Chemical Assessment (TSCA Work Plan) program. I. ACC's Vision for a TSCA Prioritization Process Consistent with the LCSA The LCSA requires EPA, by rule, to establish a risk-based screening process to designate chemicals as high or low priorities for risk evaluations. The LCSA includes criteria and considerations by which EPA must make these priority designations. To ensure EPA consistently has risk evaluations underway, the LCSA requires EPA to identify at least one new high priority for every risk evaluation that is completed. EPA's ability to designate additional priorities for 2 evaluation is limited only by the Agency's ability to complete risk evaluations in accordance with the deadlines established by Congress. Thus, Congress requires EPA to carefully choreograph the 3 identification of high priority substances for risk evaluations, in order to ensure that appropriate resources are available to complete the evaluations with the established deadlines. This implies a framework that efficiently coordinates EPA's prioritization process with EPA's risk evaluation process. ACC's vision for the prioritization process is one that enables EPA to meet all the requirements of the LCSA and congressional intent. Prioritization must be a risk based screening process in which EPA integrates hazard, use and exposure information to designate chemicals or categories of chemicals as either high or low priority for risk evaluations based on the criteria in Section 6. Information used to make prioritization decisions must be reasonably available; new information should be required through Section 4 tools only if EPA makes a determination pursuant to Section 4(a)(2)(B) that new information is necessary for prioritization. Prioritization designations must be based upon the science standards of LCSA Section 26, particularly best available science and weight of the scientific evidence. The basis for prioritization designations must be transparent and EPA's decisions must be communicated objectively and in neutral terms. ACC's vision of a prioritization process that meets these requirements includes six steps (see discussion below and the flowchart illustrating these steps on the next page and in Attachment C). ACC recommends that EPA clarify the needed timelines, criteria, tools, approaches and processes for these six steps, publish them for comment and include them in the final rule. Alternatively, EPA should propose these clarifications in a supplemental rule prior to the Agency's first application of the prioritization process. ACC's recommended six steps for the prioritization process are as follows: 1. Pool and Batch: EPA must "pool" active chemicals in commerce as candidates for designation as high or low priority for risk evaluation, based on transparent criteria/methods/approaches/tools and processes. EPA should then "batch" these candidates for information gathering. As EPA acknowledges in the "re-population" discussion of the preamble to the proposed rule4, the pace of EPA's completion of risk evaluations factors into the finalization of EPA's prioritization decisions. As a result, ACC expects that the number of candidates per "batch" for information gathering should be relatively small, at least in the early years of LCSA implementation. EPA's development of pools and batches should be subject to 2 15 U.S.C 1.2605(b)(3)(C) 3 15 U.S.C. 2605 (b)(2)(C) 4 82 Fed.Reg. 4825, 4833 (January 17, 2017). 5 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 estimated timeframes. 2. Information Gathering: Because Congress intended prioritization decisions to be based on reasonably available information, EPA should take a sequenced approach to information gathering on chemicals that EPA "batches" for prioritization. The sequenced steps should begin with EPA gathering reasonably available information about potential hazards, uses and potential exposure by relying upon sources such as read across/Quantitative Structure Activity Relationship (QSAR) information; Chemical Data Reporting (CDR) reports; EPA's CompTox Dashboard; High Production Volume (HPV) Challenge program; exposure information/models; EPA's Chemical Assessment and Management program (ChAMP); EPA's Voluntary Children's Chemical Evaluation Program (VCCEP); Canada's Chemical Management Program (CMP); OECD's eChemPortal; and robust study summaries developed under the EU's Registration, Evaluation, and Assessment of Chemicals (REACH). If this information is insufficient to designate the priority of a batched chemical, EPA should issue a notice in the Federal Register for voluntary call-ins of the type of information needed for prioritization and request discussions with manufacturers and processors of the chemicals. If voluntary information is still inadequate to prioritize, EPA should consider issuing TSCA Section 8(a) or 8(d) rules to require manufacturers/processors to collect existing information needed to prioritize. Finally, if EPA makes a determination subject to Section 4 requirements that new information is necessary to prioritize (and explaining why), EPA may issue Section 4 rules, orders or consent agreements. EPA should also be held accountable to using that information. The testing/exposure information EPA requires to be developed through Section 4 must be tiered. Finally, throughout the information gathering step, EPA should be asking whether it needs to "iterate" the information gathering process for prioritization, i.e., ask itself whether additional information should be gathered to designate a chemical as a high or low priority and if so to obtain it through the information gathering step process. 3. Sufficient Information to Designate: If EPA concludes it has sufficient information to designate the priority of a substance it can move that substance to the "Initiation of prioritization" step. If EPA concludes it has sufficient information to designate a substance as a high priority chemical, it should conduct a "pre-screening" review to identify potential data/information needs for scoping the risk evaluation (a bridging step between prioritization and scoping). If information on the chemical is deemed sufficient for scoping, the high priority chemical can then be put into the queue for "initiation" of the prioritization process at the appropriate time. If information is determined not sufficient for scoping, EPA should begin to collect/develop necessary information to scope the risk evaluation. This information screening "bridge" step should help EPA meet the 6-month statutory deadline for scoping a risk evaluation. However, this step would not replace either scoping itself or the anticipated need for EPA to collect other information during scoping. Further, it is not anticipated that this 6 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 step will develop all the information it will need for risk evaluation. EPA will not necessarily know what information it may need for risk evaluation until it actually conducts it. 4. Initiate the Priority Designation: EPA must announce a candidate for prioritization and request "relevant information" about that chemical and provide 90 days for persons to submit that information to EPA. The LCSA deadlines for priority setting (no less than 9 months; no more than 12 months) begin at this step. EPA will "pace" its priority designations to be ready when risk evaluations are near completion and ready to be replaced with a new priority. 5. Propose Priority Designation: EPA must propose a designation of a chemical as a high or low priority, including the basis for its proposal, and provide a 90 day public comment period. 6. Finalize the Designation of High Priority or Low Priority Chemical: EPA must finalize its designation of the chemical as either a high or low priority within the statutory deadlines (no less than 9 months; no more than 12 months). Low priority chemical designations are final agency action, subject to judicial review. EPA must communicate final designations of high priority chemicals very carefully to prevent the creation of "red-lists" of chemicals and other mis-interpretations by states or the marketplace. To help EPA understand ACC's vision of the prioritization process, we have attempted to capture a simplified version of it in the flowchart below. (See comments' text for more details.) 7 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226

What is the Ranking of Health Rank Score: 1?

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Low, LOW

endpoints, criteria are similarly available for both acute and chronic classification. The use of one common system allows for appropriate assessment of all substances. GHS classification information is readily available for all substances, as U.S. manufacturers have developed GHS classifications for their products to meet international requirements. ACC's support of the GHS criteria for purposes of this prioritization tool is not a categorical endorsement of the GHS criteria for any other purpose. ACC has been an active participant in the development of GHS and supports the system in principle. The GHS has not been broadly implemented to date in the U.S., although the Occupational Safety and Health Administration (OSHA) has indicated an intent to publish a regulation applying GHS in the workplace. ACC's December 29, 2009, comments on OSHA's proposed rule to modify the existing Hazard Communication Standard (HCS) to reflect the GHS urged that implementation of the GHS adhere to certain principles (e.g., continued application of the "Building Block Approach" of the Purple Book). ACC made specific recommendations concerning details of the Hazard Classification definitions, cut-off values, among others. ACC stands behind those comments. In ACC's view, the use of GHS criteria in a screening-level prioritization of chemicals can materially assist in determining which chemicals receive additional evaluation by the Environmental Protection Agency, but does not necessarily preclude the use of other appropriate, applicable criteria developed under other systems. To classify a chemical in a hazard based priority ranking where there is not direct data on the chemical, EPA can employ the full range of approaches, such as QSAR, SAR, read- across and other modeling tools in which EPA has confidence based on molecular structure. In those situations where there still remains insufficient information on either environmental or human health hazards, the chemical would be classified as "high" for its environmental or health ranking. 1. Environmental Ranking Table 1 provides a summary of how GHS criteria could be logically used for chemical management prioritization. Table 1. Environmental Safety - Hazard Ranking GHS Classification - Ranking Environmental Rank Environmental Score Acute I or Chronic I or Insufficient Information to High 4 Classify Acute II or Chronic II Medium High 3 Acute III or Chronic III/IV or Medium 2 none Not classified Low 1 August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 2. Human Health Ranking Table 2. Human Health - Hazard Ranking Health Rank GHS Classification - Human Health Ranking Score GHS CMR Cat 1a, 1b; OR Repeat Dose </= 10 mg/kg/day (oral); </= 20 mg/kg/day (dermal); </= 50 ppm/6hr/day (gas inhalation); High 4 <<= 0.2 mg/1/6h/day (vapour inhalation); </= 0.02 mg/l/6h/day (dust mist fume inhal). OR insufficient information to classify GHS CMR Cat 2; OR Repeat Dose 10 - 100 mg/kg/day (oral); 20 - 200 mg/kg/day (dermal); Medium High 50 - 250 ppm/6hr/day (gas inhalation); 3 0.2 - 1.0 mg/l/6h/day (vapour inhalation); 0.02 - 0.2 mg/l/6h/day (dust mist fume inhal). Not carcinogen/mutagen/repro/develop;OR Repeat Dose 100 - 1000 mg/kg/day (oral); 200 - 2000 mg/kg/day (dermal); Medium 250 - 1000 ppm/6hr/day (gas inhalation); 2 1.0 - 5.0 mg/l/6h/day (vapour inhalation); 0.2 - 1.0 mg/l/6h/day (dust mist fume inhal). Not carcinogen/mutagen/repro/develop; OR Repeat Dose >1000 mg/kg/day (oral); > 2000 mg/kg/day (dermal); Low > 1000 ppm/6hr/day (gas inhalation); 1 >5.0 mg/l/6h/day (vapour inhalation); > 1.0 mg/l/6h/day (dust mist fume inhal). It is important to note that specific concerns about children's health (specifically potential hazards and adverse effects on the nervous system) and those caused by endocrine disruption mechanisms are addressed in this prioritization process: The GHS CMR "R" classification includes specific evaluation of effects on development in utero and upon growth, maturation and reproduction. ("R" stands for reproductive toxicity and includes adverse effects on sexual function and fertility, as well as developmental toxicity in offspring). Endocrine activity is not a distinct toxicological hazard per se, but rather a measure of a compound's ability to interact with components of the endocrine system. The prioritization process evaluates data and information on relevant apical tests, including tests for reproduction and developmental toxicity (potential endocrine pathways). Thus, even if specific August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 screening for potential endocrine activity has not yet been conducted on certain compounds, hazard identification based on observable outcomes from apical toxicity tests (e.g., outcomes such as pathologic states indicative of disease conditions) covers all modes of action, including endocrine pathways. The toxicity information evaluated (CMR and repeat dose toxicity) is directly relevant to evaluating potential hazards to all individuals, including children. Such data typically includes: 1) identification and definition of possible hazards upon all major organ systems from both acute and repeated exposures, including the nervous system; 2) detection of potential hazards arising from in utero exposures, including possible effects on the nervous system; 3) evaluation of potential of a substance to affect reproduction; and 4) evaluation of the potential of a substance to damage DNA. Integration of Hazard Elements: Each of the environmental and human health classifications is assigned a numeric value based upon its ranking, with 1 being the lowest value and 4 the highest. The greatest ranking (highest hazard potential score) of either Environmental or Human Health is used in a substance- specific priority ranking. The numeric value does not imply relative weighting, but rather a numerical order of priority. B. Exposure Potential Ranking The screening method allows for an initial indication of the extent of exposure potential by considering: 1. The chemical's uses and use pattern(s) 2. Production volume as a first pass indicator of relative emission/release potential since magnitude and route (i.e. air, water, soil) of emissions is not available for all substances. 3. Persistence and bioaccumulation characteristics of the substance. Together the 3 elements are used to rank exposure potential. 1. Use Patterns The proposed approach applies the most current 2006 TSCA Inventory Update Reporting rule (IUR, now called the Chemical Data Reporting rule (CDR) data. To keep the initial prioritization simple and transparent, the approach "bins" different use patterns to align with general exposure potential - intermediates, industrial use, commercial use and consumer use. These patterns are the same as those reported in the IUR and are consistent with REACH exposure categories (intermediates, worker, professional, consumer). Chemicals with consumer product use are likely to have widespread potential for general population exposures and are given high priority ranking within the approach. For the initial prioritization approach, child specific products are captured under general consumer products and all consumer products are weighted equally (see additional discussion below under Second Tier Considerations). Intermediates will have low general population exposures, since these substances are consumed, by definition, within the workplace. Therefore, they are given the lowest priority ranking within the approach. In the context of the proposed approach, the intermediates category includes both intermediates and non-isolated intermediates. A chemical used in multiple use patterns is August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 assigned the priority of the highest use, e.g., a chemical in both industrial and commercial uses would be assigned the commercial Medium-High rank. Table 3. Use Patterns - Exposure Ranking Use Pattern Ranking Use Pattern Score Consumer High 4 Commercial Medium-High 3 Industrial Medium 2 Intermediates Low 1 The IUR Definitions of these terms are (40 CFR 710.3, 710.43): "consumer use" means the use of a chemical substance or a mixture containing a chemical substance (including as part of article) when sold to or made available to consumers for their use. "commercial use" means the use of a chemical substance or a mixture containing a chemical substance (including as part of an article) in a commercial enterprise providing saleable goods or services. "industrial use" means use at a site at which one or more chemical substances or mixtures are manufactured (including imported). "intermediate" means any chemical substance: which is intentionally removed from the equipment in which it is manufactured, and which either is consumed in whole or in part in chemical reaction(s) used for the intentional manufacture of other chemical substance(s) or mixture(s), or is intentionally present for the purpose of altering the rate of such chemical reaction(s) "non-isolated intermediate" means any intermediate that is not intentionally removed from the equipment in which is it manufactured, including the reaction vessel in which it is manufactured, equipment which is ancillary to the reaction vessel, and any equipment through which the substance passes during a continuous flow process, but not including tanks or other vessels in which the substance is stored after its manufacture. 2. Production Volume Recognizing that detailed exposure information will not be available for all substances to be screened, the proposed approach uses production volume as an indicator of exposure, which is widely used in many prioritization schemes. As production volume is just a rough surrogate of emissions, ACC suggests only very broad categories, covering about two orders of magnitude each. It may be useful to consider how additional exposure estimates may be applied in the second tier assessment. Table 4. Production Volume as Emission Surrogate - Exposure Ranking Production Volume as Emission Surrogate Ranking Volume Score >= 100,000,000 lbs national aggregate High 4 1,000,000 lbs to < 100,000,000 lbs national Medium - High 3 aggregate August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 >= 25,000 lbs to < 1,000,000 lbs national Medium 2 aggregate < 25,000 lbs (below IUR site reporting limit) Low 1 3. Persistence and Bioaccumulation Persistence and bioaccumulation are viewed as indicators of exposure, and therefore are considered under the exposure axis of the approach. A persistent substance that is emitted to the environment at the same rate as a non-persistent substance with similar partitioning properties will result in higher exposure to humans and the environment. In fact, multimedia modeling clearly indicates that environmental persistence in the compartment to which a substance partitions is a good indicator of human exposure potential (MacLeod & McKone et al. 2004). Similarly, substances that are not subject to biotransformation by higher organisms will exhibit a high bioaccumulation potential that results in higher exposures via the food chain (Arnot et al. 2010). Therefore, it is recommended to apply the proposed persistence and bioaccumulation criteria in assessment of exposure potential as described below. The persistent and bioaccumulative (P&B) criteria of the proposed approach are targeted toward organic chemicals. Separate assessment criteria are likely needed for P&B evaluation for inorganics/metals, as in the approach taken by Canada's Chemical Management Program (CMP). For assessing persistence, based upon recent expert consensus (Boethling et al., 2009) it is recommended to distinguish persistent from non-persistent chemicals using the following criteria: Volatile chemicals can be defined using a vapor pressure cut-off (i.e., > 1000 Pa) For volatile chemicals, persistent versus non-persistent chemicals are differentiated using a half-life cut-off in air (e.g., a substance is not persistent if air half life is < 2 days). For non-volatile chemicals, non-persistent substances can be defined as substances that are deemed: readily or inherently biodegradable using standard biodegradation tests (OECD 301, 302, 306 test guidelines) or SAR or read across from measured data on a related substance, show an equivalent degree of degradation (i.e. >20% in 28 days) via an abiotic degradation mechanism such as photolysis (OECD 316) or hydrolysi (OECD 111), evaluation of simulation data from transformation in soil, marine water/sediment, brackish water/sediment, surface water/sediment, oceanic water die away (e.g. OECD 308/309) have half lives below 180 days, OR if data are lacking, evaluation via BIOWIN model (EPIWEB 4) Non-volatile substances that are not biodegradable or subject to abiotic losses based on the above criteria would be considered persistent. For assessing bioaccumulation, the key question for screening is the potential for biomagnification based on recent expert consensus (Gobas et al. 2009). To determine if a substance has the potential to biomagnify the following metrics have been agreed: Trophic Magnification Factor (TMF)>1, fish Biomagnification Factor (BMF)>1 fish Bioaccumulation Factor (BAF)/Bioconcentration Factor (BCF) > 5000. These metrics can be August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 derived using lab or field measurements (where available) or recently improved computational models that are included in EPA's EPIWEB model that can be freely downloaded at www.epa.gov/oppt/exposure/pubs/episuite.htm. This approach allows all organics to be addressed and is a scientifically updated version of the approach used in Canada's CMP. Based on the above recommendations, substances can be grouped with regard to persistence and bioaccumulation as follows: Table 5. Persistence and Bioaccumulation - Exposure Ranking Persistence and P&B Ranking P&B Score Bioaccumulation Persistent and High 5 Bioaccumulative Persistent and Not Medium 3 Bioaccumulative OR Not Persistent and Bioaccumulative Not Persistent and Not Low 1 Bioaccumulative Integration of Exposure Elements: As demonstrated in the tables, each factor (use pattern, P&B, and production volume) would be assigned a numeric score based upon its ranking. All 3 factors are added to arrive at an overall value. These values are then separated into categories from low to high exposure potential. A proposed "banding" approach is illustrated in Table 6. Table 6. Integration of Exposure Rankings Combined Score - All 3 Exposure Rank Exposure Ranking elements Score 11 13 High 5 9 10 Medium High 4 7 8 Medium 3 5 6 Medium Low 2 3 4 Low 1 Overall Priority Grouping: In the overall approach, both hazard and exposure elements are considered when placing a substance in a risk-based prioritization ranking. The overall prioritization score for priority grouping and risk evaluation is based on the combined consideration of the hazard and exposure rankings. Priority Groups 7, 8, and 9 are deemed High Priority; Priority Groups 4, 5, and 6 are Medium Priority; and Priority Groups 2 and 3 are Low Priority. August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 Review and Comment: It is important that screening be done in an open and transparent way and that the best available information be used. When screening for thousands of chemicals, EPA may not have access to all available information. The process should provide an opportunity for review and comment on initial rankings and an opportunity to submit additional relevant data and information to update proposed rankings with improved information. III. Second Tier Considerations: After the initial screening, some substances within individual priority groupings may require further rank ordering, particularly where a large number of chemicals are in the same priority group. Listed below are the types of information that will be useful to consider in this Second Tier rank ordering: Biomonitoring/Environmental Monitoring Data: Mere detection of chemicals in humans or the environment, i.e., "found in biomonitoring (CDC), found in water (NCOD), and found in air", while providing an indication of exposure, does not provide a useful criterion for exposure potential because almost any industrial or commercial chemical could be detected at trace levels, given increasingly sensitive analytical methods. Therefore, detection alone primarily reflects only the fact that a specific chemical was included in a measurement program. This criterion will also tend to bias the prioritization of chemicals for which well-established analytical methods are available. Consequently, this criterion is not used in the initial prioritization scheme. However, within a particular priority grouping, reliable monitoring information should be considered for Second Tier rank ordering within a quantitative process that assesses if the data is above a level of concern (i.e., places it in a risk context). Use in Children's Products: Protection of childrens' health is a top priority and, in the initial ranking, child-specific products are captured under general consumer products and all consumer products are weighted equally. The specific IUR reporting of information on chemical use in products intended for children would be considered further within a particular priority grouping for Second Tier rank ordering, noting the following points: the IUR definition is based upon use in a child specific product rather than child specific exposure potential¹ (see below). Without knowing a specific product type, it is difficult to understand if 1 IUR definition (Federal Register Volume 75, Number 156, Friday August 30, 2010, p. 49686): Intended for use by children means the chemical substance or mixture is used in or on a product that is specifically intended for use by children age 14 or younger. A chemical substance or mixture is intended for use by children when the submitter answers "yes" to at least on of the following questions for the product into which the submitter's chemical substance or mixture is incorporated: (1) Is the product commonly recognized (i.e., by a reasonable person) as being intended for children age 14 or younger? (2) Does the manufacturer of the product state through product labeling or other written materials that the product is intended for or will be used by children age 14 or younger? (3) Is the advertising, promotion, or marketing of the product aimed at children age 14 or younger? August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 potential child exposure is greater than for a non-child specific product. For example, how does child exposure to a general use cleaner compare to exposure from use in a child's raincoat. In the VCCEP assessments, there are examples for inhalation exposures where estimates of passive child exposure during adult product use exceeded conservative estimates of child exposure during active use of a child-specific product (such as a hobby product) - differences were related to the amount of product used and substance concentration within the product (MEK VCCEP Submission). the IUR definition targets children age 14 and younger. Younger children may be exposed to a variety of non-child specific products that are in general household use. Older children may be exposed to a variety of additional products. the IUR information request is targeted to manufacturers, which may not have direct knowledge of all uses, particularly the presence in products for specific subpopulations, such as children. Therefore, it is not clear that the information requested for the IUR information would be consistently available across all substances being screened. Ideally, this information should be requested from formulators of child-specific products. Therefore, for the initial prioritization approach, which represents a broad, unrefined categorization, child specific products are captured under general consumer products and all consumer products are weighted equally. The IUR information on child specific use would be utilized within a particular priority grouping for Second Tier rank ordering. If the IUR information is utilized, it is important that the limitations above be considered in its application. Emissions Data: Production volume, which is readily available for substances, is used in this proposed approach, but only serves as a surrogate for environmental emissions. For further prioritization, data or estimates of environmental emissions can be used to refine prioritization. Estimates of environmental emissions will be available for some substances (e.g., TRI data). When TRI data are utilized it should be recognized that it addresses only emissions that result from industrial and not wide dispersive uses. In other cases, emissions estimates can be developed as a percentage of production volume based upon consideration of use categories. Within a particular priority grouping, available emissions information can be considered for Second Tier rank ordering, with the understanding that emissions information is not an indicator of actual exposure. Similarly, non-isolated system intermediates, by definition, would have de minimis exposure potential. Therefore, this IUR information could be considered within a particular priority grouping for Second Tier rank ordering. International Risk Management Actions: An initial screening approach for chemical prioritization should be based upon consistent application of specific hazard and exposure science elements that define risk potential. The hazard and exposure elements should be applicable across all substances being evaluated. For initial screening, existence of international risk management action plans should not be a factor that determines priority grouping. Risk management plans may be based upon many factors, including political drivers. It is unclear how factors, their relative weighting, and the rigor of the evaluation may vary across agencies and substances. For initial screening August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 purposes, the same science-based criteria should be used to rank all substances. Consideration of existing international risk management plans could be utilized to check the functioning of the approach and could be considered within a particular priority grouping for Second Tier rank ordering with the possible effect of moving a chemical up in a grouping if actions are being taken internationally. IV. Summary ACC's prioritization approach is an example of a risk-based screening prioritization process that implements the general principles outlined at the outset of this document. It is based upon widely available information that can be utilized to understand the relative priority of chemicals for further evaluation from a risk perspective, i.e., integrating both hazard and exposure elements. Implementation of the screening framework will be most effective when utilizing the best available information. When conducting screening for thousands of chemicals, EPA may not have access to all available information. An open and iterative process that includes an opportunity for review and comment on initial rankings, together with the information that led to the result, and an opportunity to update the ranking with improved information will create a transparent and scientifically sound process. V. References Arnot, J.A., D. Mackay, T. F. Parkerton, R. T. Zaleski, C.S. Warren (2010), Multimedia modeling of human exposure to chemical substances: The roles of food web biomagnification and biotransformation, Environmental Toxicology and Chemistry 29(1):45-55. Boethling, R., K. Fenner, P. Howard, G. Klecka, T. Madsen, J.R. Snape, M.J. Whelan (2009). Environmental persistence of organic pollutants: guidance for development and review of POP risk profiles. Integrated Environmental Assessment and Management 5(4): 539 - 556. Gobas, F.A.P.C, W. de Wolf, L. P Burkhard, E. Verbruggen, K. Plotzke (2009). Revisiting Bioaccumulation Criteria for POPs and PBT Assessments Integrated Environmental Assessment and Management, 5(4):624-637. MacLeod, M., T. E. McKone (2004). Multimedia persistence as an indicator of potential for population-level intake of environmental contaminants, Environmental Toxicology and Chemistry 23(10):2465-2472. van Wijk,D., R. Chénier, T. Henry, M. D Hernando, C. Schulte (2009). Integrated Approach to PBT and POP Prioritization and Risk Assessment' Integrated Environmental Assessment and Management, 5(4):697-711. August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 Proposed Prioritization Approach DRAFT May & 2011 Exposure Elements nat commental consumer 20 2 3 a 33 3 not 8 or Persuntence S not 3 mai 35 a & not 3 Pas $ 3 S the iss = the Tormages RUN $ 3 3 SUM - P8 - Tavamage ranow 3 -13 Expesure Ramking $5 Based os Sum (UN# + pa * Townage PRIORITY GROUPING - Hazard * Expasure Ramkings - 1-8 3-10 11-13 mad Jow Hazard - Highter and Human $ 3 3 & $ Human Mazard Not on Dase 3 low mai * anou % 1000 numour 3 1.8 (duet Nume " 3 & 3 8 Not 100 Acure mi os : 3 A 2000 and not data) 280 v 1000 (pas 1.0 8.0 nomour 8.3 miss Nome 3 & % x CMR Cat 2, on Dawe Call 3: 10 - 3 is # 200 50 ase Igas 0.3 1.0 0.0% - 0.2 mis forme * # $ y GMS CMR Can on OHS Clowe Clat % Repeat Close 10 § on 8 on insurticient 20 information to - - - 0.3 wis 0,00 mist on information to $ 3 a $ August 29, 2011 Source: :https://www.industrydocuments.ucsf.edu/docs/jzbn0226 Hazard and Exposure Criteria for Prioritization Approach HAZARD EXPOSURE Environment and Human Health Classifications based upon GHS Use Elements - based upon IUR Intermediate consumed during industrial processing Envirommental: industrial (not intermediate) - used in an industrial setting From GHS classification guidance document: commercial occupational use in nonindustrial setting Table 4.1.2: scheme for substances hazardous so the aquatic environment. consumer general population residential use Clacufication Persistence: Loag-term Votalile substance (VPS 1000 Pax: Not Persistent if air half life <2 days a (Nate 2) Nonvolatile (VP < 1000 Pa): Not Persistent if: Adequate dass Adequnte voriciny dasa aux a) ready biodegradability (OBCD 301) Rapidly 3 b) inherent biodegradability (OBCD 301, 302, 306) degredable 0) read across from measured data on a related substance. 28 (Note. 3) d) equivalent degree of degradation (i.e. >20% in 28 days) via an abjotic Arute 3 Categorys Chronic 1 Categury: 1 Categasy: I degradation mechanism such as photolysis (OBCD 316) or hydrolysis (OBCD NOEC ar ECA 0.1 NOE - EC cass L 1.00 md of maid 111) and/ar BCF a 200 OR, a substance is Not Persistent if: if e) evaluation of simulation data from transformation in soil, marine water/sediment, Caregusy: Acore 2 Category: Chronic 2 Caregury: Chrumin 2 Caregusy: Chruaic 2 brackish water/sediment, surface water/sediment, oceanic water die away (e.g., OECD 3.00 s: s 10.9 0.1 - NOEC er EC. 13 0.00 <: NOEC - EC, 502 3.00 L(EXC) 10.8 and of andies 308/309) have half lives below 180 days. BCF = 500 as if K. 2 4 OR, if data are lacking: Caregusy: Arnie 3 Caregury: 3 Chrinia 3 f) evaluation via BIOWIN model (EPIWEB 4) 01 EC. : 30,00 1- 100 and fack of Bioaccomulation: stapoid andier BOF: Re 300 if absent log x 3 4 A substance is not bioaccumulative if: 4 4) a) measured TMF < 1 (field study) 3) b) measured fish BMF <1 (lab study) Ne tericity and lack of and BCF 2 500 ase, lag E 4, c) measured fish BCF < 5000 (lab study) MOECA 1 mal d) predicted BCP< 5000 using the BCFBAF model included in EPIWIN 4 The above order reflects the preference for use in decision- making NOTE -- P&B CRITERIA ARB FOR ORGANICS Tonnage - based upon JUR reporting ranges <. 25,000 lbs (below IUR site reporting limit) Human Health: 25.000 - <1 MM lbs national aggregate As above, based upon GHS 1MM - <100 MM lbs national aggregate >100 MM lbs national aggregate August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 Risk-Based Prioritization Matrix Ancreasing Exposure Two-Step towest Prionies Prioritization Process Incregaling Second Tier Rank Ordering within Priority Groups Biomonitoring / Environmental Monitoring Use in Children's Products Emissions (e.g. TRI) International Risk Management Actions Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226

Health Rank Score of Ranking: Medium High?

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endpoints, criteria are similarly available for both acute and chronic classification. The use of one common system allows for appropriate assessment of all substances. GHS classification information is readily available for all substances, as U.S. manufacturers have developed GHS classifications for their products to meet international requirements. ACC's support of the GHS criteria for purposes of this prioritization tool is not a categorical endorsement of the GHS criteria for any other purpose. ACC has been an active participant in the development of GHS and supports the system in principle. The GHS has not been broadly implemented to date in the U.S., although the Occupational Safety and Health Administration (OSHA) has indicated an intent to publish a regulation applying GHS in the workplace. ACC's December 29, 2009, comments on OSHA's proposed rule to modify the existing Hazard Communication Standard (HCS) to reflect the GHS urged that implementation of the GHS adhere to certain principles (e.g., continued application of the "Building Block Approach" of the Purple Book). ACC made specific recommendations concerning details of the Hazard Classification definitions, cut-off values, among others. ACC stands behind those comments. In ACC's view, the use of GHS criteria in a screening-level prioritization of chemicals can materially assist in determining which chemicals receive additional evaluation by the Environmental Protection Agency, but does not necessarily preclude the use of other appropriate, applicable criteria developed under other systems. To classify a chemical in a hazard based priority ranking where there is not direct data on the chemical, EPA can employ the full range of approaches, such as QSAR, SAR, read- across and other modeling tools in which EPA has confidence based on molecular structure. In those situations where there still remains insufficient information on either environmental or human health hazards, the chemical would be classified as "high" for its environmental or health ranking. 1. Environmental Ranking Table 1 provides a summary of how GHS criteria could be logically used for chemical management prioritization. Table 1. Environmental Safety - Hazard Ranking GHS Classification - Ranking Environmental Rank Environmental Score Acute I or Chronic I or Insufficient Information to High 4 Classify Acute II or Chronic II Medium High 3 Acute III or Chronic III/IV or Medium 2 none Not classified Low 1 August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 2. Human Health Ranking Table 2. Human Health - Hazard Ranking Health Rank GHS Classification - Human Health Ranking Score GHS CMR Cat 1a, 1b; OR Repeat Dose </= 10 mg/kg/day (oral); </= 20 mg/kg/day (dermal); </= 50 ppm/6hr/day (gas inhalation); High 4 <<= 0.2 mg/1/6h/day (vapour inhalation); </= 0.02 mg/l/6h/day (dust mist fume inhal). OR insufficient information to classify GHS CMR Cat 2; OR Repeat Dose 10 - 100 mg/kg/day (oral); 20 - 200 mg/kg/day (dermal); Medium High 50 - 250 ppm/6hr/day (gas inhalation); 3 0.2 - 1.0 mg/l/6h/day (vapour inhalation); 0.02 - 0.2 mg/l/6h/day (dust mist fume inhal). Not carcinogen/mutagen/repro/develop;OR Repeat Dose 100 - 1000 mg/kg/day (oral); 200 - 2000 mg/kg/day (dermal); Medium 250 - 1000 ppm/6hr/day (gas inhalation); 2 1.0 - 5.0 mg/l/6h/day (vapour inhalation); 0.2 - 1.0 mg/l/6h/day (dust mist fume inhal). Not carcinogen/mutagen/repro/develop; OR Repeat Dose >1000 mg/kg/day (oral); > 2000 mg/kg/day (dermal); Low > 1000 ppm/6hr/day (gas inhalation); 1 >5.0 mg/l/6h/day (vapour inhalation); > 1.0 mg/l/6h/day (dust mist fume inhal). It is important to note that specific concerns about children's health (specifically potential hazards and adverse effects on the nervous system) and those caused by endocrine disruption mechanisms are addressed in this prioritization process: The GHS CMR "R" classification includes specific evaluation of effects on development in utero and upon growth, maturation and reproduction. ("R" stands for reproductive toxicity and includes adverse effects on sexual function and fertility, as well as developmental toxicity in offspring). Endocrine activity is not a distinct toxicological hazard per se, but rather a measure of a compound's ability to interact with components of the endocrine system. The prioritization process evaluates data and information on relevant apical tests, including tests for reproduction and developmental toxicity (potential endocrine pathways). Thus, even if specific August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 screening for potential endocrine activity has not yet been conducted on certain compounds, hazard identification based on observable outcomes from apical toxicity tests (e.g., outcomes such as pathologic states indicative of disease conditions) covers all modes of action, including endocrine pathways. The toxicity information evaluated (CMR and repeat dose toxicity) is directly relevant to evaluating potential hazards to all individuals, including children. Such data typically includes: 1) identification and definition of possible hazards upon all major organ systems from both acute and repeated exposures, including the nervous system; 2) detection of potential hazards arising from in utero exposures, including possible effects on the nervous system; 3) evaluation of potential of a substance to affect reproduction; and 4) evaluation of the potential of a substance to damage DNA. Integration of Hazard Elements: Each of the environmental and human health classifications is assigned a numeric value based upon its ranking, with 1 being the lowest value and 4 the highest. The greatest ranking (highest hazard potential score) of either Environmental or Human Health is used in a substance- specific priority ranking. The numeric value does not imply relative weighting, but rather a numerical order of priority. B. Exposure Potential Ranking The screening method allows for an initial indication of the extent of exposure potential by considering: 1. The chemical's uses and use pattern(s) 2. Production volume as a first pass indicator of relative emission/release potential since magnitude and route (i.e. air, water, soil) of emissions is not available for all substances. 3. Persistence and bioaccumulation characteristics of the substance. Together the 3 elements are used to rank exposure potential. 1. Use Patterns The proposed approach applies the most current 2006 TSCA Inventory Update Reporting rule (IUR, now called the Chemical Data Reporting rule (CDR) data. To keep the initial prioritization simple and transparent, the approach "bins" different use patterns to align with general exposure potential - intermediates, industrial use, commercial use and consumer use. These patterns are the same as those reported in the IUR and are consistent with REACH exposure categories (intermediates, worker, professional, consumer). Chemicals with consumer product use are likely to have widespread potential for general population exposures and are given high priority ranking within the approach. For the initial prioritization approach, child specific products are captured under general consumer products and all consumer products are weighted equally (see additional discussion below under Second Tier Considerations). Intermediates will have low general population exposures, since these substances are consumed, by definition, within the workplace. Therefore, they are given the lowest priority ranking within the approach. In the context of the proposed approach, the intermediates category includes both intermediates and non-isolated intermediates. A chemical used in multiple use patterns is August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 assigned the priority of the highest use, e.g., a chemical in both industrial and commercial uses would be assigned the commercial Medium-High rank. Table 3. Use Patterns - Exposure Ranking Use Pattern Ranking Use Pattern Score Consumer High 4 Commercial Medium-High 3 Industrial Medium 2 Intermediates Low 1 The IUR Definitions of these terms are (40 CFR 710.3, 710.43): "consumer use" means the use of a chemical substance or a mixture containing a chemical substance (including as part of article) when sold to or made available to consumers for their use. "commercial use" means the use of a chemical substance or a mixture containing a chemical substance (including as part of an article) in a commercial enterprise providing saleable goods or services. "industrial use" means use at a site at which one or more chemical substances or mixtures are manufactured (including imported). "intermediate" means any chemical substance: which is intentionally removed from the equipment in which it is manufactured, and which either is consumed in whole or in part in chemical reaction(s) used for the intentional manufacture of other chemical substance(s) or mixture(s), or is intentionally present for the purpose of altering the rate of such chemical reaction(s) "non-isolated intermediate" means any intermediate that is not intentionally removed from the equipment in which is it manufactured, including the reaction vessel in which it is manufactured, equipment which is ancillary to the reaction vessel, and any equipment through which the substance passes during a continuous flow process, but not including tanks or other vessels in which the substance is stored after its manufacture. 2. Production Volume Recognizing that detailed exposure information will not be available for all substances to be screened, the proposed approach uses production volume as an indicator of exposure, which is widely used in many prioritization schemes. As production volume is just a rough surrogate of emissions, ACC suggests only very broad categories, covering about two orders of magnitude each. It may be useful to consider how additional exposure estimates may be applied in the second tier assessment. Table 4. Production Volume as Emission Surrogate - Exposure Ranking Production Volume as Emission Surrogate Ranking Volume Score >= 100,000,000 lbs national aggregate High 4 1,000,000 lbs to < 100,000,000 lbs national Medium - High 3 aggregate August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 >= 25,000 lbs to < 1,000,000 lbs national Medium 2 aggregate < 25,000 lbs (below IUR site reporting limit) Low 1 3. Persistence and Bioaccumulation Persistence and bioaccumulation are viewed as indicators of exposure, and therefore are considered under the exposure axis of the approach. A persistent substance that is emitted to the environment at the same rate as a non-persistent substance with similar partitioning properties will result in higher exposure to humans and the environment. In fact, multimedia modeling clearly indicates that environmental persistence in the compartment to which a substance partitions is a good indicator of human exposure potential (MacLeod & McKone et al. 2004). Similarly, substances that are not subject to biotransformation by higher organisms will exhibit a high bioaccumulation potential that results in higher exposures via the food chain (Arnot et al. 2010). Therefore, it is recommended to apply the proposed persistence and bioaccumulation criteria in assessment of exposure potential as described below. The persistent and bioaccumulative (P&B) criteria of the proposed approach are targeted toward organic chemicals. Separate assessment criteria are likely needed for P&B evaluation for inorganics/metals, as in the approach taken by Canada's Chemical Management Program (CMP). For assessing persistence, based upon recent expert consensus (Boethling et al., 2009) it is recommended to distinguish persistent from non-persistent chemicals using the following criteria: Volatile chemicals can be defined using a vapor pressure cut-off (i.e., > 1000 Pa) For volatile chemicals, persistent versus non-persistent chemicals are differentiated using a half-life cut-off in air (e.g., a substance is not persistent if air half life is < 2 days). For non-volatile chemicals, non-persistent substances can be defined as substances that are deemed: readily or inherently biodegradable using standard biodegradation tests (OECD 301, 302, 306 test guidelines) or SAR or read across from measured data on a related substance, show an equivalent degree of degradation (i.e. >20% in 28 days) via an abiotic degradation mechanism such as photolysis (OECD 316) or hydrolysi (OECD 111), evaluation of simulation data from transformation in soil, marine water/sediment, brackish water/sediment, surface water/sediment, oceanic water die away (e.g. OECD 308/309) have half lives below 180 days, OR if data are lacking, evaluation via BIOWIN model (EPIWEB 4) Non-volatile substances that are not biodegradable or subject to abiotic losses based on the above criteria would be considered persistent. For assessing bioaccumulation, the key question for screening is the potential for biomagnification based on recent expert consensus (Gobas et al. 2009). To determine if a substance has the potential to biomagnify the following metrics have been agreed: Trophic Magnification Factor (TMF)>1, fish Biomagnification Factor (BMF)>1 fish Bioaccumulation Factor (BAF)/Bioconcentration Factor (BCF) > 5000. These metrics can be August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 derived using lab or field measurements (where available) or recently improved computational models that are included in EPA's EPIWEB model that can be freely downloaded at www.epa.gov/oppt/exposure/pubs/episuite.htm. This approach allows all organics to be addressed and is a scientifically updated version of the approach used in Canada's CMP. Based on the above recommendations, substances can be grouped with regard to persistence and bioaccumulation as follows: Table 5. Persistence and Bioaccumulation - Exposure Ranking Persistence and P&B Ranking P&B Score Bioaccumulation Persistent and High 5 Bioaccumulative Persistent and Not Medium 3 Bioaccumulative OR Not Persistent and Bioaccumulative Not Persistent and Not Low 1 Bioaccumulative Integration of Exposure Elements: As demonstrated in the tables, each factor (use pattern, P&B, and production volume) would be assigned a numeric score based upon its ranking. All 3 factors are added to arrive at an overall value. These values are then separated into categories from low to high exposure potential. A proposed "banding" approach is illustrated in Table 6. Table 6. Integration of Exposure Rankings Combined Score - All 3 Exposure Rank Exposure Ranking elements Score 11 13 High 5 9 10 Medium High 4 7 8 Medium 3 5 6 Medium Low 2 3 4 Low 1 Overall Priority Grouping: In the overall approach, both hazard and exposure elements are considered when placing a substance in a risk-based prioritization ranking. The overall prioritization score for priority grouping and risk evaluation is based on the combined consideration of the hazard and exposure rankings. Priority Groups 7, 8, and 9 are deemed High Priority; Priority Groups 4, 5, and 6 are Medium Priority; and Priority Groups 2 and 3 are Low Priority. August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 Review and Comment: It is important that screening be done in an open and transparent way and that the best available information be used. When screening for thousands of chemicals, EPA may not have access to all available information. The process should provide an opportunity for review and comment on initial rankings and an opportunity to submit additional relevant data and information to update proposed rankings with improved information. III. Second Tier Considerations: After the initial screening, some substances within individual priority groupings may require further rank ordering, particularly where a large number of chemicals are in the same priority group. Listed below are the types of information that will be useful to consider in this Second Tier rank ordering: Biomonitoring/Environmental Monitoring Data: Mere detection of chemicals in humans or the environment, i.e., "found in biomonitoring (CDC), found in water (NCOD), and found in air", while providing an indication of exposure, does not provide a useful criterion for exposure potential because almost any industrial or commercial chemical could be detected at trace levels, given increasingly sensitive analytical methods. Therefore, detection alone primarily reflects only the fact that a specific chemical was included in a measurement program. This criterion will also tend to bias the prioritization of chemicals for which well-established analytical methods are available. Consequently, this criterion is not used in the initial prioritization scheme. However, within a particular priority grouping, reliable monitoring information should be considered for Second Tier rank ordering within a quantitative process that assesses if the data is above a level of concern (i.e., places it in a risk context). Use in Children's Products: Protection of childrens' health is a top priority and, in the initial ranking, child-specific products are captured under general consumer products and all consumer products are weighted equally. The specific IUR reporting of information on chemical use in products intended for children would be considered further within a particular priority grouping for Second Tier rank ordering, noting the following points: the IUR definition is based upon use in a child specific product rather than child specific exposure potential¹ (see below). Without knowing a specific product type, it is difficult to understand if 1 IUR definition (Federal Register Volume 75, Number 156, Friday August 30, 2010, p. 49686): Intended for use by children means the chemical substance or mixture is used in or on a product that is specifically intended for use by children age 14 or younger. A chemical substance or mixture is intended for use by children when the submitter answers "yes" to at least on of the following questions for the product into which the submitter's chemical substance or mixture is incorporated: (1) Is the product commonly recognized (i.e., by a reasonable person) as being intended for children age 14 or younger? (2) Does the manufacturer of the product state through product labeling or other written materials that the product is intended for or will be used by children age 14 or younger? (3) Is the advertising, promotion, or marketing of the product aimed at children age 14 or younger? August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 potential child exposure is greater than for a non-child specific product. For example, how does child exposure to a general use cleaner compare to exposure from use in a child's raincoat. In the VCCEP assessments, there are examples for inhalation exposures where estimates of passive child exposure during adult product use exceeded conservative estimates of child exposure during active use of a child-specific product (such as a hobby product) - differences were related to the amount of product used and substance concentration within the product (MEK VCCEP Submission). the IUR definition targets children age 14 and younger. Younger children may be exposed to a variety of non-child specific products that are in general household use. Older children may be exposed to a variety of additional products. the IUR information request is targeted to manufacturers, which may not have direct knowledge of all uses, particularly the presence in products for specific subpopulations, such as children. Therefore, it is not clear that the information requested for the IUR information would be consistently available across all substances being screened. Ideally, this information should be requested from formulators of child-specific products. Therefore, for the initial prioritization approach, which represents a broad, unrefined categorization, child specific products are captured under general consumer products and all consumer products are weighted equally. The IUR information on child specific use would be utilized within a particular priority grouping for Second Tier rank ordering. If the IUR information is utilized, it is important that the limitations above be considered in its application. Emissions Data: Production volume, which is readily available for substances, is used in this proposed approach, but only serves as a surrogate for environmental emissions. For further prioritization, data or estimates of environmental emissions can be used to refine prioritization. Estimates of environmental emissions will be available for some substances (e.g., TRI data). When TRI data are utilized it should be recognized that it addresses only emissions that result from industrial and not wide dispersive uses. In other cases, emissions estimates can be developed as a percentage of production volume based upon consideration of use categories. Within a particular priority grouping, available emissions information can be considered for Second Tier rank ordering, with the understanding that emissions information is not an indicator of actual exposure. Similarly, non-isolated system intermediates, by definition, would have de minimis exposure potential. Therefore, this IUR information could be considered within a particular priority grouping for Second Tier rank ordering. International Risk Management Actions: An initial screening approach for chemical prioritization should be based upon consistent application of specific hazard and exposure science elements that define risk potential. The hazard and exposure elements should be applicable across all substances being evaluated. For initial screening, existence of international risk management action plans should not be a factor that determines priority grouping. Risk management plans may be based upon many factors, including political drivers. It is unclear how factors, their relative weighting, and the rigor of the evaluation may vary across agencies and substances. For initial screening August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 purposes, the same science-based criteria should be used to rank all substances. Consideration of existing international risk management plans could be utilized to check the functioning of the approach and could be considered within a particular priority grouping for Second Tier rank ordering with the possible effect of moving a chemical up in a grouping if actions are being taken internationally. IV. Summary ACC's prioritization approach is an example of a risk-based screening prioritization process that implements the general principles outlined at the outset of this document. It is based upon widely available information that can be utilized to understand the relative priority of chemicals for further evaluation from a risk perspective, i.e., integrating both hazard and exposure elements. Implementation of the screening framework will be most effective when utilizing the best available information. When conducting screening for thousands of chemicals, EPA may not have access to all available information. An open and iterative process that includes an opportunity for review and comment on initial rankings, together with the information that led to the result, and an opportunity to update the ranking with improved information will create a transparent and scientifically sound process. V. References Arnot, J.A., D. Mackay, T. F. Parkerton, R. T. Zaleski, C.S. Warren (2010), Multimedia modeling of human exposure to chemical substances: The roles of food web biomagnification and biotransformation, Environmental Toxicology and Chemistry 29(1):45-55. Boethling, R., K. Fenner, P. Howard, G. Klecka, T. Madsen, J.R. Snape, M.J. Whelan (2009). Environmental persistence of organic pollutants: guidance for development and review of POP risk profiles. Integrated Environmental Assessment and Management 5(4): 539 - 556. Gobas, F.A.P.C, W. de Wolf, L. P Burkhard, E. Verbruggen, K. Plotzke (2009). Revisiting Bioaccumulation Criteria for POPs and PBT Assessments Integrated Environmental Assessment and Management, 5(4):624-637. MacLeod, M., T. E. McKone (2004). Multimedia persistence as an indicator of potential for population-level intake of environmental contaminants, Environmental Toxicology and Chemistry 23(10):2465-2472. van Wijk,D., R. Chénier, T. Henry, M. D Hernando, C. Schulte (2009). Integrated Approach to PBT and POP Prioritization and Risk Assessment' Integrated Environmental Assessment and Management, 5(4):697-711. August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 Proposed Prioritization Approach DRAFT May & 2011 Exposure Elements nat commental consumer 20 2 3 a 33 3 not 8 or Persuntence S not 3 mai 35 a & not 3 Pas $ 3 S the iss = the Tormages RUN $ 3 3 SUM - P8 - Tavamage ranow 3 -13 Expesure Ramking $5 Based os Sum (UN# + pa * Townage PRIORITY GROUPING - Hazard * Expasure Ramkings - 1-8 3-10 11-13 mad Jow Hazard - Highter and Human $ 3 3 & $ Human Mazard Not on Dase 3 low mai * anou % 1000 numour 3 1.8 (duet Nume " 3 & 3 8 Not 100 Acure mi os : 3 A 2000 and not data) 280 v 1000 (pas 1.0 8.0 nomour 8.3 miss Nome 3 & % x CMR Cat 2, on Dawe Call 3: 10 - 3 is # 200 50 ase Igas 0.3 1.0 0.0% - 0.2 mis forme * # $ y GMS CMR Can on OHS Clowe Clat % Repeat Close 10 § on 8 on insurticient 20 information to - - - 0.3 wis 0,00 mist on information to $ 3 a $ August 29, 2011 Source: :https://www.industrydocuments.ucsf.edu/docs/jzbn0226 Hazard and Exposure Criteria for Prioritization Approach HAZARD EXPOSURE Environment and Human Health Classifications based upon GHS Use Elements - based upon IUR Intermediate consumed during industrial processing Envirommental: industrial (not intermediate) - used in an industrial setting From GHS classification guidance document: commercial occupational use in nonindustrial setting Table 4.1.2: scheme for substances hazardous so the aquatic environment. consumer general population residential use Clacufication Persistence: Loag-term Votalile substance (VPS 1000 Pax: Not Persistent if air half life <2 days a (Nate 2) Nonvolatile (VP < 1000 Pa): Not Persistent if: Adequate dass Adequnte voriciny dasa aux a) ready biodegradability (OBCD 301) Rapidly 3 b) inherent biodegradability (OBCD 301, 302, 306) degredable 0) read across from measured data on a related substance. 28 (Note. 3) d) equivalent degree of degradation (i.e. >20% in 28 days) via an abjotic Arute 3 Categorys Chronic 1 Categury: 1 Categasy: I degradation mechanism such as photolysis (OBCD 316) or hydrolysis (OBCD NOEC ar ECA 0.1 NOE - EC cass L 1.00 md of maid 111) and/ar BCF a 200 OR, a substance is Not Persistent if: if e) evaluation of simulation data from transformation in soil, marine water/sediment, Caregusy: Acore 2 Category: Chronic 2 Caregury: Chrumin 2 Caregusy: Chruaic 2 brackish water/sediment, surface water/sediment, oceanic water die away (e.g., OECD 3.00 s: s 10.9 0.1 - NOEC er EC. 13 0.00 <: NOEC - EC, 502 3.00 L(EXC) 10.8 and of andies 308/309) have half lives below 180 days. BCF = 500 as if K. 2 4 OR, if data are lacking: Caregusy: Arnie 3 Caregury: 3 Chrinia 3 f) evaluation via BIOWIN model (EPIWEB 4) 01 EC. : 30,00 1- 100 and fack of Bioaccomulation: stapoid andier BOF: Re 300 if absent log x 3 4 A substance is not bioaccumulative if: 4 4) a) measured TMF < 1 (field study) 3) b) measured fish BMF <1 (lab study) Ne tericity and lack of and BCF 2 500 ase, lag E 4, c) measured fish BCF < 5000 (lab study) MOECA 1 mal d) predicted BCP< 5000 using the BCFBAF model included in EPIWIN 4 The above order reflects the preference for use in decision- making NOTE -- P&B CRITERIA ARB FOR ORGANICS Tonnage - based upon JUR reporting ranges <. 25,000 lbs (below IUR site reporting limit) Human Health: 25.000 - <1 MM lbs national aggregate As above, based upon GHS 1MM - <100 MM lbs national aggregate >100 MM lbs national aggregate August 29, 2011 Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226 Risk-Based Prioritization Matrix Ancreasing Exposure Two-Step towest Prionies Prioritization Process Incregaling Second Tier Rank Ordering within Priority Groups Biomonitoring / Environmental Monitoring Use in Children's Products Emissions (e.g. TRI) International Risk Management Actions Source: https://www.industrydocuments.ucsf.edu/docs/jzbn0226

What is the critical tool used for American Crop production?

nhcn0226

nhcn0226_p0, nhcn0226_p1, nhcn0226_p2, nhcn0226_p3

Chlorpyrifos

American Agriculture Speaks Out in Support of Chlorpyrifos (Jan 16, 2017) The attached petitions with 2300 signatures in support of chlorpyrifos, represent American growers, farmers and others from across the U.S. who are involved in producing the food American consumers rely on and the crops that are important exports supporting U.S. trade. Signees have a simple, common message to EPA: We ask you, the US EPA to retain the current crop tolerances and the continued registration and availability of use of the chlorpyrifos-containing products we need. Those involved with production of citrus, corn &soybean, cotton, wheat and sugar beets have petitions specific to their crop so they could emphasize the critical importance of chlorpyrifos to their operations. Crop-specific petitions were signed by; 199 for citrus 619 for corn & soybean 187 for cotton 399 for wheat 224 for sugar beets For other crops, 672, representing the full range of crops on labels for chlorpyrifos products, signed the petition. Petitions were signed during EPA's public comment period for EPA's Chlorpyrifos: Tolerance Revocations; Notice of Data Availability and Request [EPA-HQ-2015-0653] from November 17, 2016 to January 16, 2017.Signatures were collected by Dow AgroSciences and are being submitted by Dow AgroSciences with the understanding and agreement of those who signed the petitions. Submitted on January 16, 2017 by: Dow AgroSciences, LLC 9330 Zionsville Rd Indianapolis, IN 46268 1 Source: https://www.industrydocuments.ucsf.edu/docs/nhcn0226 Chlorpyrifos is a critical tool for American crop production In the United States, growers of more than 50 different types of crops, including cereal, oil, forage, fruit, nut and vegetable crops count on chlorpyrifos as a critical tool. Farmers rely on chlorpyrifos because of its efficacy, broad-spectrum control, low cost, and tank mix compatibility. For many important pests, growers face limited or no viable alternatives to chlorpyrifos. And, when an outbreak of a new pest occurs, growers look to chlorpyrifos as a proven first-line of defense. Growers also look to chlorpyrifos for the ease of implementation into existing Integrated Pest Management and Integrated Resistance Management programs, and the minimal impact on beneficial insects compared to alternative chemistries. We ask you, the US EPA to retain the current crop tolerances and the continued registration and availability of use of the chlorpyrifos-containing products we need. First Name Last Name State Yes / have read and understand that this petition will be submitted into official public comment dockets and any personal information included may be publicly viewable Indicate yes by checking here Manfred Schosnig OR 1 KENNETH TAMURA IDAHO 1 Jimmy Wood Ga. 1 mark hawke GA 1 Don Tolmie Idaho 1 Katherine Blanchard WA 1 Joe Weitz ID 1 Leland Tiegs Idaho 1 Matthew Ray GA 1 Keith Kubik California 1 Gary Lucas Idaho 1 Gene Schmitt Idaho 1 Leslie Dean ID 1 Richard Matteson North Dakota 1 Justin Lynch Washington 1 Kevin Marshall Oregon 1 Sidney Naito ID 1 Grady Whiddon Ga 1 Matthew Hamilton OR 1 Austin Purvis Georgia 1 2 Source: https://www.industrydocuments.ucsf.edu/docs/nhcn0226 Talley Brim Ga your Joel Horn CO 1 Harold Mckay Oregon you Josh White GA 1 Darin Garland GA for Donna Cowart GA your Matt Taylor GA 1 Chase Floyd GA you Willle Wiggins GA 1 Jimmy Wiggins GA 1 Greg Howard Ga for Jeffrey Howard GA 1 Lamar White GA 1 Rebecca White GA 1 McKinley White GA 1 June Howard GA 1 Aaron Wolff KS 1 Kenneth Tucker KS 1 Michael Bahr Kansas 1 Cole McCurry KS 1 Ryan Mcbride Oklahoma 1 Shawn Thornton Ks 1 Travis Kolm Kansas 1 Keith Hulteen Colorado 1 Brett Despain Idaho 1 Julie Gordon MI 1 Brent Sutton DE 1 russell byerley washington 1 Josh Prow WA 1 Kevin Schwertfeger Kansas 1 Timothy Guttridge OREGON 1 Thomas Egan Oregon 1 jeff Newton Oregon y Justin Jones Georgia 1 Matt Storlie Idaño 1 Willis Connell NC 1 Tim Semier NO 1 shawn knudson north dakota y JP Tom Bodderij Arizona 1 Jason Richter North Dakota 1 Wayne Christ North Dakota 1 Ben Lee ND 1 Andy Grundstad North Dakota 1 William McMullin UT 1 3 Source: https://www.industrydocuments.ucsf.edu/docs/nhcn0226 Damon Christensen Washington 1 Alan Gilbert WASHINGTON 1 Brett Lolley Idaho you Lynn Register NC 1 Scott Ginn NC for Robble Whitfleld NC your Marvin Sutton NC 1 Brock Leonard WA you MERLE BLOCK NO 1 Douglas Duerst Oregon 1 Nancy Aerni OR for Kyle Gilbert WA 1 Marty Coble WA 1 James Cadwallader NM 1 Wyatt Smith Oregon 1 Brian Dugo California 1 Nicholas Martin KS 1 David George SC 1 Sarah Cassel North Dakota 1 Jerry Domes Oregon 1 Sam Krautscheld WA 1 James Boyles Georgia 1 Tamara Duchsherer NO 1 Angela Beehler WA 1 Steven Thonney Washington 1 Todd Crosby Oregon 1 Mark Millard Oregon 1 Wally D Huppert Washington 1 Michael McKoen Oregon 1 Craig St. Hilaire WA 1 John Meeks Georgia 1 Neal Braswell GA 1 Jay Hendley Georgia y William Ward NC 1 Joseph Brincks NO 1 Lily Hyman NC 1 Ross Greene GA 1 Brian Walsh North Dakota y Galen scheresky NO 1 Greg Schultheis WA 1 Justin Krieg NO 1 James Freeman Georgia 1 Crystal Gaillard Georgia 1 Ronald Juris Washington 1 4 Source: https://www.industrydocuments.ucsf.edu/docs/nhcn0226

Why do farmers rely on Chlorpyrifos?

nhcn0226

nhcn0226_p0, nhcn0226_p1, nhcn0226_p2, nhcn0226_p3

because of its efficacy, broad spectrum control, low cost, and tank mix compatibility.

American Agriculture Speaks Out in Support of Chlorpyrifos (Jan 16, 2017) The attached petitions with 2300 signatures in support of chlorpyrifos, represent American growers, farmers and others from across the U.S. who are involved in producing the food American consumers rely on and the crops that are important exports supporting U.S. trade. Signees have a simple, common message to EPA: We ask you, the US EPA to retain the current crop tolerances and the continued registration and availability of use of the chlorpyrifos-containing products we need. Those involved with production of citrus, corn &soybean, cotton, wheat and sugar beets have petitions specific to their crop so they could emphasize the critical importance of chlorpyrifos to their operations. Crop-specific petitions were signed by; 199 for citrus 619 for corn & soybean 187 for cotton 399 for wheat 224 for sugar beets For other crops, 672, representing the full range of crops on labels for chlorpyrifos products, signed the petition. Petitions were signed during EPA's public comment period for EPA's Chlorpyrifos: Tolerance Revocations; Notice of Data Availability and Request [EPA-HQ-2015-0653] from November 17, 2016 to January 16, 2017.Signatures were collected by Dow AgroSciences and are being submitted by Dow AgroSciences with the understanding and agreement of those who signed the petitions. Submitted on January 16, 2017 by: Dow AgroSciences, LLC 9330 Zionsville Rd Indianapolis, IN 46268 1 Source: https://www.industrydocuments.ucsf.edu/docs/nhcn0226 Chlorpyrifos is a critical tool for American crop production In the United States, growers of more than 50 different types of crops, including cereal, oil, forage, fruit, nut and vegetable crops count on chlorpyrifos as a critical tool. Farmers rely on chlorpyrifos because of its efficacy, broad-spectrum control, low cost, and tank mix compatibility. For many important pests, growers face limited or no viable alternatives to chlorpyrifos. And, when an outbreak of a new pest occurs, growers look to chlorpyrifos as a proven first-line of defense. Growers also look to chlorpyrifos for the ease of implementation into existing Integrated Pest Management and Integrated Resistance Management programs, and the minimal impact on beneficial insects compared to alternative chemistries. We ask you, the US EPA to retain the current crop tolerances and the continued registration and availability of use of the chlorpyrifos-containing products we need. First Name Last Name State Yes / have read and understand that this petition will be submitted into official public comment dockets and any personal information included may be publicly viewable Indicate yes by checking here Manfred Schosnig OR 1 KENNETH TAMURA IDAHO 1 Jimmy Wood Ga. 1 mark hawke GA 1 Don Tolmie Idaho 1 Katherine Blanchard WA 1 Joe Weitz ID 1 Leland Tiegs Idaho 1 Matthew Ray GA 1 Keith Kubik California 1 Gary Lucas Idaho 1 Gene Schmitt Idaho 1 Leslie Dean ID 1 Richard Matteson North Dakota 1 Justin Lynch Washington 1 Kevin Marshall Oregon 1 Sidney Naito ID 1 Grady Whiddon Ga 1 Matthew Hamilton OR 1 Austin Purvis Georgia 1 2 Source: https://www.industrydocuments.ucsf.edu/docs/nhcn0226 Talley Brim Ga your Joel Horn CO 1 Harold Mckay Oregon you Josh White GA 1 Darin Garland GA for Donna Cowart GA your Matt Taylor GA 1 Chase Floyd GA you Willle Wiggins GA 1 Jimmy Wiggins GA 1 Greg Howard Ga for Jeffrey Howard GA 1 Lamar White GA 1 Rebecca White GA 1 McKinley White GA 1 June Howard GA 1 Aaron Wolff KS 1 Kenneth Tucker KS 1 Michael Bahr Kansas 1 Cole McCurry KS 1 Ryan Mcbride Oklahoma 1 Shawn Thornton Ks 1 Travis Kolm Kansas 1 Keith Hulteen Colorado 1 Brett Despain Idaho 1 Julie Gordon MI 1 Brent Sutton DE 1 russell byerley washington 1 Josh Prow WA 1 Kevin Schwertfeger Kansas 1 Timothy Guttridge OREGON 1 Thomas Egan Oregon 1 jeff Newton Oregon y Justin Jones Georgia 1 Matt Storlie Idaño 1 Willis Connell NC 1 Tim Semier NO 1 shawn knudson north dakota y JP Tom Bodderij Arizona 1 Jason Richter North Dakota 1 Wayne Christ North Dakota 1 Ben Lee ND 1 Andy Grundstad North Dakota 1 William McMullin UT 1 3 Source: https://www.industrydocuments.ucsf.edu/docs/nhcn0226 Damon Christensen Washington 1 Alan Gilbert WASHINGTON 1 Brett Lolley Idaho you Lynn Register NC 1 Scott Ginn NC for Robble Whitfleld NC your Marvin Sutton NC 1 Brock Leonard WA you MERLE BLOCK NO 1 Douglas Duerst Oregon 1 Nancy Aerni OR for Kyle Gilbert WA 1 Marty Coble WA 1 James Cadwallader NM 1 Wyatt Smith Oregon 1 Brian Dugo California 1 Nicholas Martin KS 1 David George SC 1 Sarah Cassel North Dakota 1 Jerry Domes Oregon 1 Sam Krautscheld WA 1 James Boyles Georgia 1 Tamara Duchsherer NO 1 Angela Beehler WA 1 Steven Thonney Washington 1 Todd Crosby Oregon 1 Mark Millard Oregon 1 Wally D Huppert Washington 1 Michael McKoen Oregon 1 Craig St. Hilaire WA 1 John Meeks Georgia 1 Neal Braswell GA 1 Jay Hendley Georgia y William Ward NC 1 Joseph Brincks NO 1 Lily Hyman NC 1 Ross Greene GA 1 Brian Walsh North Dakota y Galen scheresky NO 1 Greg Schultheis WA 1 Justin Krieg NO 1 James Freeman Georgia 1 Crystal Gaillard Georgia 1 Ronald Juris Washington 1 4 Source: https://www.industrydocuments.ucsf.edu/docs/nhcn0226

When a outbreak of a new pest occurs, what do growers look to?

nhcn0226

nhcn0226_p0, nhcn0226_p1, nhcn0226_p2, nhcn0226_p3

Chlorpyrifos, Chlorpyrifos as a proven first-line of defense, Chlorpyrifos as a proven first-line of defense.

American Agriculture Speaks Out in Support of Chlorpyrifos (Jan 16, 2017) The attached petitions with 2300 signatures in support of chlorpyrifos, represent American growers, farmers and others from across the U.S. who are involved in producing the food American consumers rely on and the crops that are important exports supporting U.S. trade. Signees have a simple, common message to EPA: We ask you, the US EPA to retain the current crop tolerances and the continued registration and availability of use of the chlorpyrifos-containing products we need. Those involved with production of citrus, corn &soybean, cotton, wheat and sugar beets have petitions specific to their crop so they could emphasize the critical importance of chlorpyrifos to their operations. Crop-specific petitions were signed by; 199 for citrus 619 for corn & soybean 187 for cotton 399 for wheat 224 for sugar beets For other crops, 672, representing the full range of crops on labels for chlorpyrifos products, signed the petition. Petitions were signed during EPA's public comment period for EPA's Chlorpyrifos: Tolerance Revocations; Notice of Data Availability and Request [EPA-HQ-2015-0653] from November 17, 2016 to January 16, 2017.Signatures were collected by Dow AgroSciences and are being submitted by Dow AgroSciences with the understanding and agreement of those who signed the petitions. Submitted on January 16, 2017 by: Dow AgroSciences, LLC 9330 Zionsville Rd Indianapolis, IN 46268 1 Source: https://www.industrydocuments.ucsf.edu/docs/nhcn0226 Chlorpyrifos is a critical tool for American crop production In the United States, growers of more than 50 different types of crops, including cereal, oil, forage, fruit, nut and vegetable crops count on chlorpyrifos as a critical tool. Farmers rely on chlorpyrifos because of its efficacy, broad-spectrum control, low cost, and tank mix compatibility. For many important pests, growers face limited or no viable alternatives to chlorpyrifos. And, when an outbreak of a new pest occurs, growers look to chlorpyrifos as a proven first-line of defense. Growers also look to chlorpyrifos for the ease of implementation into existing Integrated Pest Management and Integrated Resistance Management programs, and the minimal impact on beneficial insects compared to alternative chemistries. We ask you, the US EPA to retain the current crop tolerances and the continued registration and availability of use of the chlorpyrifos-containing products we need. First Name Last Name State Yes / have read and understand that this petition will be submitted into official public comment dockets and any personal information included may be publicly viewable Indicate yes by checking here Manfred Schosnig OR 1 KENNETH TAMURA IDAHO 1 Jimmy Wood Ga. 1 mark hawke GA 1 Don Tolmie Idaho 1 Katherine Blanchard WA 1 Joe Weitz ID 1 Leland Tiegs Idaho 1 Matthew Ray GA 1 Keith Kubik California 1 Gary Lucas Idaho 1 Gene Schmitt Idaho 1 Leslie Dean ID 1 Richard Matteson North Dakota 1 Justin Lynch Washington 1 Kevin Marshall Oregon 1 Sidney Naito ID 1 Grady Whiddon Ga 1 Matthew Hamilton OR 1 Austin Purvis Georgia 1 2 Source: https://www.industrydocuments.ucsf.edu/docs/nhcn0226 Talley Brim Ga your Joel Horn CO 1 Harold Mckay Oregon you Josh White GA 1 Darin Garland GA for Donna Cowart GA your Matt Taylor GA 1 Chase Floyd GA you Willle Wiggins GA 1 Jimmy Wiggins GA 1 Greg Howard Ga for Jeffrey Howard GA 1 Lamar White GA 1 Rebecca White GA 1 McKinley White GA 1 June Howard GA 1 Aaron Wolff KS 1 Kenneth Tucker KS 1 Michael Bahr Kansas 1 Cole McCurry KS 1 Ryan Mcbride Oklahoma 1 Shawn Thornton Ks 1 Travis Kolm Kansas 1 Keith Hulteen Colorado 1 Brett Despain Idaho 1 Julie Gordon MI 1 Brent Sutton DE 1 russell byerley washington 1 Josh Prow WA 1 Kevin Schwertfeger Kansas 1 Timothy Guttridge OREGON 1 Thomas Egan Oregon 1 jeff Newton Oregon y Justin Jones Georgia 1 Matt Storlie Idaño 1 Willis Connell NC 1 Tim Semier NO 1 shawn knudson north dakota y JP Tom Bodderij Arizona 1 Jason Richter North Dakota 1 Wayne Christ North Dakota 1 Ben Lee ND 1 Andy Grundstad North Dakota 1 William McMullin UT 1 3 Source: https://www.industrydocuments.ucsf.edu/docs/nhcn0226 Damon Christensen Washington 1 Alan Gilbert WASHINGTON 1 Brett Lolley Idaho you Lynn Register NC 1 Scott Ginn NC for Robble Whitfleld NC your Marvin Sutton NC 1 Brock Leonard WA you MERLE BLOCK NO 1 Douglas Duerst Oregon 1 Nancy Aerni OR for Kyle Gilbert WA 1 Marty Coble WA 1 James Cadwallader NM 1 Wyatt Smith Oregon 1 Brian Dugo California 1 Nicholas Martin KS 1 David George SC 1 Sarah Cassel North Dakota 1 Jerry Domes Oregon 1 Sam Krautscheld WA 1 James Boyles Georgia 1 Tamara Duchsherer NO 1 Angela Beehler WA 1 Steven Thonney Washington 1 Todd Crosby Oregon 1 Mark Millard Oregon 1 Wally D Huppert Washington 1 Michael McKoen Oregon 1 Craig St. Hilaire WA 1 John Meeks Georgia 1 Neal Braswell GA 1 Jay Hendley Georgia y William Ward NC 1 Joseph Brincks NO 1 Lily Hyman NC 1 Ross Greene GA 1 Brian Walsh North Dakota y Galen scheresky NO 1 Greg Schultheis WA 1 Justin Krieg NO 1 James Freeman Georgia 1 Crystal Gaillard Georgia 1 Ronald Juris Washington 1 4 Source: https://www.industrydocuments.ucsf.edu/docs/nhcn0226

Which state of United States does Justiin Lynch belongs to?

nhcn0226

nhcn0226_p0, nhcn0226_p1, nhcn0226_p2, nhcn0226_p3

Washington

American Agriculture Speaks Out in Support of Chlorpyrifos (Jan 16, 2017) The attached petitions with 2300 signatures in support of chlorpyrifos, represent American growers, farmers and others from across the U.S. who are involved in producing the food American consumers rely on and the crops that are important exports supporting U.S. trade. Signees have a simple, common message to EPA: We ask you, the US EPA to retain the current crop tolerances and the continued registration and availability of use of the chlorpyrifos-containing products we need. Those involved with production of citrus, corn &soybean, cotton, wheat and sugar beets have petitions specific to their crop so they could emphasize the critical importance of chlorpyrifos to their operations. Crop-specific petitions were signed by; 199 for citrus 619 for corn & soybean 187 for cotton 399 for wheat 224 for sugar beets For other crops, 672, representing the full range of crops on labels for chlorpyrifos products, signed the petition. Petitions were signed during EPA's public comment period for EPA's Chlorpyrifos: Tolerance Revocations; Notice of Data Availability and Request [EPA-HQ-2015-0653] from November 17, 2016 to January 16, 2017.Signatures were collected by Dow AgroSciences and are being submitted by Dow AgroSciences with the understanding and agreement of those who signed the petitions. Submitted on January 16, 2017 by: Dow AgroSciences, LLC 9330 Zionsville Rd Indianapolis, IN 46268 1 Source: https://www.industrydocuments.ucsf.edu/docs/nhcn0226 Chlorpyrifos is a critical tool for American crop production In the United States, growers of more than 50 different types of crops, including cereal, oil, forage, fruit, nut and vegetable crops count on chlorpyrifos as a critical tool. Farmers rely on chlorpyrifos because of its efficacy, broad-spectrum control, low cost, and tank mix compatibility. For many important pests, growers face limited or no viable alternatives to chlorpyrifos. And, when an outbreak of a new pest occurs, growers look to chlorpyrifos as a proven first-line of defense. Growers also look to chlorpyrifos for the ease of implementation into existing Integrated Pest Management and Integrated Resistance Management programs, and the minimal impact on beneficial insects compared to alternative chemistries. We ask you, the US EPA to retain the current crop tolerances and the continued registration and availability of use of the chlorpyrifos-containing products we need. First Name Last Name State Yes / have read and understand that this petition will be submitted into official public comment dockets and any personal information included may be publicly viewable Indicate yes by checking here Manfred Schosnig OR 1 KENNETH TAMURA IDAHO 1 Jimmy Wood Ga. 1 mark hawke GA 1 Don Tolmie Idaho 1 Katherine Blanchard WA 1 Joe Weitz ID 1 Leland Tiegs Idaho 1 Matthew Ray GA 1 Keith Kubik California 1 Gary Lucas Idaho 1 Gene Schmitt Idaho 1 Leslie Dean ID 1 Richard Matteson North Dakota 1 Justin Lynch Washington 1 Kevin Marshall Oregon 1 Sidney Naito ID 1 Grady Whiddon Ga 1 Matthew Hamilton OR 1 Austin Purvis Georgia 1 2 Source: https://www.industrydocuments.ucsf.edu/docs/nhcn0226 Talley Brim Ga your Joel Horn CO 1 Harold Mckay Oregon you Josh White GA 1 Darin Garland GA for Donna Cowart GA your Matt Taylor GA 1 Chase Floyd GA you Willle Wiggins GA 1 Jimmy Wiggins GA 1 Greg Howard Ga for Jeffrey Howard GA 1 Lamar White GA 1 Rebecca White GA 1 McKinley White GA 1 June Howard GA 1 Aaron Wolff KS 1 Kenneth Tucker KS 1 Michael Bahr Kansas 1 Cole McCurry KS 1 Ryan Mcbride Oklahoma 1 Shawn Thornton Ks 1 Travis Kolm Kansas 1 Keith Hulteen Colorado 1 Brett Despain Idaho 1 Julie Gordon MI 1 Brent Sutton DE 1 russell byerley washington 1 Josh Prow WA 1 Kevin Schwertfeger Kansas 1 Timothy Guttridge OREGON 1 Thomas Egan Oregon 1 jeff Newton Oregon y Justin Jones Georgia 1 Matt Storlie Idaño 1 Willis Connell NC 1 Tim Semier NO 1 shawn knudson north dakota y JP Tom Bodderij Arizona 1 Jason Richter North Dakota 1 Wayne Christ North Dakota 1 Ben Lee ND 1 Andy Grundstad North Dakota 1 William McMullin UT 1 3 Source: https://www.industrydocuments.ucsf.edu/docs/nhcn0226 Damon Christensen Washington 1 Alan Gilbert WASHINGTON 1 Brett Lolley Idaho you Lynn Register NC 1 Scott Ginn NC for Robble Whitfleld NC your Marvin Sutton NC 1 Brock Leonard WA you MERLE BLOCK NO 1 Douglas Duerst Oregon 1 Nancy Aerni OR for Kyle Gilbert WA 1 Marty Coble WA 1 James Cadwallader NM 1 Wyatt Smith Oregon 1 Brian Dugo California 1 Nicholas Martin KS 1 David George SC 1 Sarah Cassel North Dakota 1 Jerry Domes Oregon 1 Sam Krautscheld WA 1 James Boyles Georgia 1 Tamara Duchsherer NO 1 Angela Beehler WA 1 Steven Thonney Washington 1 Todd Crosby Oregon 1 Mark Millard Oregon 1 Wally D Huppert Washington 1 Michael McKoen Oregon 1 Craig St. Hilaire WA 1 John Meeks Georgia 1 Neal Braswell GA 1 Jay Hendley Georgia y William Ward NC 1 Joseph Brincks NO 1 Lily Hyman NC 1 Ross Greene GA 1 Brian Walsh North Dakota y Galen scheresky NO 1 Greg Schultheis WA 1 Justin Krieg NO 1 James Freeman Georgia 1 Crystal Gaillard Georgia 1 Ronald Juris Washington 1 4 Source: https://www.industrydocuments.ucsf.edu/docs/nhcn0226

How much percentage of the work do the sponsors in the list comprise of?

lmcn0226

lmcn0226_p2, lmcn0226_p3

2% or more, 2% OR MORE

2015 TERA Project Time by Sponsor 6% Collaborators Coalition of Project Sponsors Alliance for Risk Assessment Beyond Science and Decisions: From Problem Formation to Dose Response Kids Chemical Safety Webpage For Profit 32% OARS: WEEL Project Sponsorsi American Chemistry Council Amgen Coca Cola Genentech GOJO Hamp, Mathews & Associates, Inc, Steptoe & Johnson 2% Education Training Projects 68% Government/Non-Profit Project Sponsors Dose-Response Boot Camp Consumer Product Safety Commission Health Canada International Life Sciences International Texas Commission on Environmental Quality The sponsors listed above are sponsors that each comprise 2% or more of our work. 25 12015 T E R A Annual Report Source: https://www.industrydocuments.ucsf.edu/docs//Imcn0226 2014 TERA Project Time by Sponsor 43% 2% For Profit Training Projects/Sponsors Projects/Sponsors + American Cleaning Institute + Dose Response Boot Camp + Amgen + FDA Training Course + Eli Lily + Genentech + Morrison & Foerster + Quinn 57% 9% Government/ Collaborations Nonprofit Projects/Sponsors Projects/Sponsors + Consumer Product Safety Commission + Alliance for Risk Assessment TCE Coaltion + ERM: Alaska Sulfolane + Beyond Science & Decisions + Health Canada + Kidschemicalsafety.org + West Virginia Spill - MCHM + Occupational Alliance for Risk Assessment Source: https://www.industrydocuments.ucsf.edu/docs/Imcn0226

What is the percentage of Government/Non-Profit project sponsors?

lmcn0226

lmcn0226_p2, lmcn0226_p3

68%

2015 TERA Project Time by Sponsor 6% Collaborators Coalition of Project Sponsors Alliance for Risk Assessment Beyond Science and Decisions: From Problem Formation to Dose Response Kids Chemical Safety Webpage For Profit 32% OARS: WEEL Project Sponsorsi American Chemistry Council Amgen Coca Cola Genentech GOJO Hamp, Mathews & Associates, Inc, Steptoe & Johnson 2% Education Training Projects 68% Government/Non-Profit Project Sponsors Dose-Response Boot Camp Consumer Product Safety Commission Health Canada International Life Sciences International Texas Commission on Environmental Quality The sponsors listed above are sponsors that each comprise 2% or more of our work. 25 12015 T E R A Annual Report Source: https://www.industrydocuments.ucsf.edu/docs//Imcn0226 2014 TERA Project Time by Sponsor 43% 2% For Profit Training Projects/Sponsors Projects/Sponsors + American Cleaning Institute + Dose Response Boot Camp + Amgen + FDA Training Course + Eli Lily + Genentech + Morrison & Foerster + Quinn 57% 9% Government/ Collaborations Nonprofit Projects/Sponsors Projects/Sponsors + Consumer Product Safety Commission + Alliance for Risk Assessment TCE Coaltion + ERM: Alaska Sulfolane + Beyond Science & Decisions + Health Canada + Kidschemicalsafety.org + West Virginia Spill - MCHM + Occupational Alliance for Risk Assessment Source: https://www.industrydocuments.ucsf.edu/docs/Imcn0226

What is the percentage of For Profit Project Sponsors?

lmcn0226

lmcn0226_p2, lmcn0226_p3

32%

2015 TERA Project Time by Sponsor 6% Collaborators Coalition of Project Sponsors Alliance for Risk Assessment Beyond Science and Decisions: From Problem Formation to Dose Response Kids Chemical Safety Webpage For Profit 32% OARS: WEEL Project Sponsorsi American Chemistry Council Amgen Coca Cola Genentech GOJO Hamp, Mathews & Associates, Inc, Steptoe & Johnson 2% Education Training Projects 68% Government/Non-Profit Project Sponsors Dose-Response Boot Camp Consumer Product Safety Commission Health Canada International Life Sciences International Texas Commission on Environmental Quality The sponsors listed above are sponsors that each comprise 2% or more of our work. 25 12015 T E R A Annual Report Source: https://www.industrydocuments.ucsf.edu/docs//Imcn0226 2014 TERA Project Time by Sponsor 43% 2% For Profit Training Projects/Sponsors Projects/Sponsors + American Cleaning Institute + Dose Response Boot Camp + Amgen + FDA Training Course + Eli Lily + Genentech + Morrison & Foerster + Quinn 57% 9% Government/ Collaborations Nonprofit Projects/Sponsors Projects/Sponsors + Consumer Product Safety Commission + Alliance for Risk Assessment TCE Coaltion + ERM: Alaska Sulfolane + Beyond Science & Decisions + Health Canada + Kidschemicalsafety.org + West Virginia Spill - MCHM + Occupational Alliance for Risk Assessment Source: https://www.industrydocuments.ucsf.edu/docs/Imcn0226

What does Pg 81: 2nd and 3rd paragraphs, and the 1st paragraph on the next page discuss about?

hzbn0226

hzbn0226_p30, hzbn0226_p31, hzbn0226_p32, hzbn0226_p33, hzbn0226_p34, hzbn0226_p35, hzbn0226_p36, hzbn0226_p37, hzbn0226_p38, hzbn0226_p39, hzbn0226_p40, hzbn0226_p41, hzbn0226_p42, hzbn0226_p43, hzbn0226_p44, hzbn0226_p45, hzbn0226_p46, hzbn0226_p47, hzbn0226_p48, hzbn0226_p49, hzbn0226_p50, hzbn0226_p51, hzbn0226_p52, hzbn0226_p53, hzbn0226_p54, hzbn0226_p55

DEFICITS IN VISUAL PERCEPTION, all three of these paragraphs discuss on deficits in visual perception.

INTERAGENCY DRAFT DELIBERATIVE Is 20mg/kg a reasonable dose to expect humans to receive? Is this dose level relevant to todays exposure levels? Does it make sense to set an RfD in this situation?? Is there anything EPA is confident of? Are there any data on mechanism of action that may help? Page 48 suggest deleting: "Furthermore, a developmental neurotoxicity study in mice has been conducted (Viberg et al., 2003). Considering all the problems with the study design, its hard to believe that EPA believes this study fulfills all the criteria for DNT testing. Its not clear to me why an UF for database is not needed here. What is it that makes the Deca database so much stronger than the other BDEs? Is this sentence true: "When an RfD is based on systemic NOAEL of 1120 mg/kg/day from the NTP study, a database UF should be applied." Doesn't it depend on the database not the actual study that was used? Page 49-discussion of EP As confidence in the proposed RfD is missing. Page 52- Just because the data can be modeled, doesn't explain why quantitation is conducted, when the weight of evidence is only suggestive and for each endpoint the strength of evidence is relatively weak. Did EPA choose to model only because it could be done? What is EPAs confidence in the values that come out of the model considering the WOE? why did EPA choose to use the linear multistage model? Were any other options discussed or tried? Does the fact that not mutagenicity is seen decrease EPAs confidence in doing this quantitatively? Page 53 what has changed since 1987, when EPA decided not to do a quantitative cancer value? how does the NRC cancer slope factor derivation differ from the EPA derivation? Did they use similar methodologies and similar studies? If not, why were EPAs choices different? Page 54 "DecaBDE also has been shown to induce spontaneous motor behavior changes in one study of male mice neurobehavioral toxicity." "These data suggested that there is a critical window for the induction of behavioral disturbances, and the neurotoxic effect of neonatal decaBDE exposure was persistent and also worsened with age in male mice. Page 55 more narrative discussion of the cancer classification is needed. Source: https://www.industrydocuments.ucsf.edu/docs/hzbn0226 INTERAGENCY DRAFT DELIBERATIVE "In addition, only one study limited tests on motor activity was were-conducted. This paragraph certainly undermines EP As rationale for why a database UF is not needed. Page 56- considering that the evidence is suggestive, EPA should discuss how reliable the slope factor value is believed to be. What is the confidence in this number? Does EPA suggest that it be broadly used? Is there a dose level above or below which is should be used? NIEHS comments: December 2005 CHARGE TO EXTERNAL REVIEWERS FOR THE IRIS TOXICOLOGICAL REVIEWS OF 2,2',4,4'-Tetrabromodiphenyl Ether (BDE-47) CASRN 5436-43-1 2,2',4,4' ,5-Pentabromodipheny Ether (BDE-99) CASRN 60348-60-9 2',4,4',5,5'-Hexabromodiphenyl Ether (BDE-153) CASRN 68631-49-2 2',3,3',4,4',5,5',6,6'-Decabromodipheny Ether (BDE-209) CASRN 1163-19-5 The U.S. EPA is conducting a peer review of the scientific basis supporting the human health assessment of BDE-47, BDE-99, BDE-153 and BDE-209 that will appear on the Agency's online databasé, the Integrated Risk Information System (IRIS). The draft documents for the external peer review contain a description of the oral database, reference dose, qualitative cancer assessment for BDE-47, BDE-99 and BDE-153, and a quantitative cancer assessment for BDE- 209. Please provide detailed responses to the charge questions below. GENERAL QUESTION Are you aware of other published peer-reviewed toxicological studies not included in these Toxicological Reviews that could be of relevance to the health assessment of BDE-47, BDE- 99, BDE-153 or BDE-209? 1. QUESTIONS RELATED TO THE DERIVATION OF THE REFERENCE DOSE FOR BDE-47, BDE-99, BDE-153 and BDE-209 1.1 Have the rationale and justification for deriving RfDs on the basis of the neurobehavioral toxicity studies been transparently and objectively described in the Toxicological Reviews of BDE-47, BDE-99, BDE-153 and BDE-209? Are there additional studies that should be considered for deriving the RfDs for any of the four PBDE congeners? The Eriksson, Viberg et al group at the Uppsala Univeristy, Sweden have reported on various neurotoxic effects of the PBDE isomers. Generally it is appropriate to use these studies for the RfDs. 1.2 Are the Eriksson et al., 2001 (BDE-47), Viberg et al., 2004 (BDE-99), Viberg et al., 2003a (BDE-153) and the Viberg et al., 2003b (BDE-209) studies appropriate for determining the point of departure? Source: https://www.industrydocuments.ucsf.edu/docs/hzbn0226 INTERAGENC DRAFT DELIBERATIVE 1.3 Have the most appropriate critical effect and point of departure been selected? And hasthe rationale for the point of departure been transparently and objectively described? 1.4 Have the rationale and justification for each uncertainty factors (UFs) selected in the draft Toxicological Reviews of BDE-47, BDE-99, BDE-153 and BDE-209 been transparently described? If the selected UFs are not appropriate, what alternative UFs would you suggest and what are the scientific rationales for those suggested? 2. BODY BURDEN APPROACH 2.1 Are there adequate data for considering body burden as an alternative dose metric to administered doses in any of the RfD derivations? The Birnbaum and Burka references on TK of the PBDEs need to be added and analyzed. Sanders JM, Burka LT, Smith CS, Black W, James R, Cunningham, ML. 2005. Differential expression of CYPIA, 2B, and 3A genes in the F344 rat following exposure to a polybrominated diphenyl ether mixture or individual components. Toxicological Sciences, 88:127-33. Sanders JM, Chen L-J, Lebetkin EH, Burka LT. 2006. Metabolism and disposition of 2,2',4,4'- tetrabromodiphenyl ether following administration of single or multiple doses to rats and mice. Xenobiotica (in press). 2.2 Do you agree with the rationale described in the Toxicological Review of BDE-99 that the data on the window of susceptibility of the cholinergic receptors to BDE-99 tend to minimize body burden concerns? 3. QUESTIONS RELATED TO THE CARCINOGENICITY ASSESSMENT OF BDE-209 3.1 Is the weight of evidence for the carcinogenicity of BDE-209 in the draft Toxicological Review appropriately described? Are there additional studies that should be included? No - see additional comments below: 3.2 Do the available data support the descriptor Suggestive evidence of carcinogenic potential for BDE-209 according to the U.S. EPA. (2005) Guidelines for Carcinogen Risk Assessment? If not, what alternative descriptor would be supported by the existing data and what is the scientific rationale? OK, but not complete. 3.3 Is the estimation of a cancer slope factor for BDE-209 in the Toxicological Review appropriate? Have the rationale and justification for the use of linear low-dose extrapolation been objectively and transparently presented? ) Source: https://www.industrydocuments.ucsf.edu/docs/hzbn0226 INTERAGENCY DRAFT DELIBERATIVE 3.4 Are there alternative modeling approaches that should have been considered instead of or in addition to the low-dose extrapolation approach? See comment on added references. 1-09-06 - EPA Review of PBDEs The major data gap in our knowledge on the toxicity of the polybrominated diphenyl ethers, is the toxic/cancer potential after long term exposures to these chemicals. The NTP's studies of these compounds is focused on filling this datagap, particularly after in utero/postnatal/adult exposures. It will be several years before these studies are completed. I. EPA Toxicological Review of BDE-209; BDE-47, BDD-99, and BDE-153 a. The carcinogenicity assessment of BDE-209 is primarily based on the 1986 NTP TR study of decabromodiphenyl ether. The NTP TR reference (and also the NTP web site reference) should be added to the reference list for this report. This NTP study is used for the EP A Benchmark dose modeling. The oral RfD for BDE-209 is 7 ug/kg/day (NTP Study, 1986); Viberg 2003). The oral RfD for BDE-47 is 0.1 ug/kg/day (Eriksson, 2001; neurobehavioral study in mice). The oral Rfd for BDE-99 is 0.1 ug/kg/day (Viberg, 2004 reference - locomotion and rearing habituation in mice). The oral Rfd for BDE-153 is 0.2 ug/kg/day (Viberg 2003 reference - spontaneous motor behavior, learning, and memory endpoints in mice). b. Missing from the EPA Toxicologic review of decabromodiphenyl ether (BDE-209) is a complete analysis of BDE-209 to the environment and the resultant chemical exposures.. When decabromodiphenyl ether is released into the environment does the chemical break down to lower brominated diphenyl ethers? If so, the hazard from exposure may be more extensive. Decabromodiphenyl ether - does this chemical break down to lower brominated diphenyl ethers? 1. Stapleton, H.M., R.J. Letcher, and J.E. Baker, Debromination of polyhrominated diphenyl ether congeners BDE 99 and BDE 183 in the intestinal tract of the common carp (Cyprinus carpio). Environmental Science & Technology, 2004. 38(4): p. 1054-1061. 2. Eriksson, J., et al., Photochemical decomposition of 15 polybrominated diphenyl ether congeners in methanol/water. Environmental Science & Technology, 2004. 38(11): p. 3119-3125. 3. Bezares-Cruz, J., C.T. Jafvert, and I. Hua, Solar photodecomposition of decabromodiphenyl ether: Products and quantum yield. Environmental Science & Technology, 2004. 38(15): p. 4149-4156. Source: https://www.industrydocuments.ucsf.edu/docs/hzbn0226 INTERAGENCY DRAFT DELIBERATIVE 4. Watanabe, I. and S. Sakai, Environmental release and behavior of brominated flame retardants. Environment International, 2003. 29(6): p. 665-682. 5. Gouin, T. and T. Harner, Modelling the environmental fate of the polybrominated diphenyl ethers. Environment International, 2003. 29(6): p. 717-724. 6. Keum and Li. Reductive debromination of polybrominated diphenyl ethers' by zerovalaent iron. Environ Sci Techonology, 2005. 7. Hites, Global assessment of polybrominated diphenyl ethers in farmed and wild salmon. Environ Sci Technol. 38: 4945-9, 2004 c. Calculations to determine the amount of PBDEs released into the environment, and how this correlates to environmental concentrations should be calculated. An update on the CDC nhanes data for the PBDE monitoring program would be helpful. d. The EPA reviews of PBDEs omit the ATSDR Reference for the Toxicologic Profiles for these chemical: ATSDR Profile on PBDEs attp://www.atsdr.cdc.gov/toxprofiles/tp68.html d. Other References: McDonald, T. A. Polybrominated diphenylether levels among United States residents: daily intake and risk of harm to the developing brain and reproductive organs, Integrated Enviroinmental Assessment and Management 1: 343-354, 2005. D'Silva et al. Brominated organic micropollutants - igniting the flame retardant issu. Critical Reviews in Environmental Science and Technology 34: 141-207, 2004. Other References: Kodavanti and Ward, Differenctial effects of commercial polybrominated diphenyl ether and polychlorinated biphenyl mixtures on intracellular signaling in rat brain in vitro Toxicologic Sciences 85: 952-962, 2005. Stapleton et al Polybominated diphenyl ethers in house duse and chlotes dryer lint, Envi Science Technology 39: 925-931,2005. Brown et al. Analysis of AH receptor pathway activation by brominated flame retardants. Chemosphere 55: 1509-1518,2004. Weber and Kuch. Relevance of BFRs and thermal conditions of the formation pathways of brominated and bromanted-chlorinated dibenzodioxins and dibenxofurans. Environmental Internation 29: 699-710, 2003. Gallard et al Rate contants of reactions of bromine with phenols in aqueous solution. Water Research 37: 2883-2892, 2003. Source: https://www.industrydocuments.ucsf.edu/docs/hzbn0226 INTERAGENCY DRAFT DELIBERATIVE Talsness et al Ultrastructural changes observed in rat ovaries following in utero and lactational exposure to low doses of a polybrmonated flame retardant. Tox. Let 157: 189-205, 2005 . Kuriyama et al. Developmental exposure to low-dose PBDE-99 effects on male fertility and neurobehaviro in rat offspring. Envi Health Persp. 113:149-154, 2005. Smeds and Saukko. Brominated flame retardants and phenolic endocrine disrupters in Finnish human adipose tissue. Chemosphere 53: 1123-1130, 2003. Darnerud and Risberg. Tissue localization of tetra- and pentabromodiphenyl ether congeners 9BDE-47,-85-, and -99) in perinatal and adult C57B1 mice. Chemosphere 62; 485-93, 2006. Jones-Otazo et al Is house dust the missing exposure pathway for PBDEs? An analysis of the urban fate and human exposure to PBDEs. Enviroin Sci Technol 39: 5121-30. 2005. Darnerud et al. Common viral infection affects pentabrominated diphenyl ether distribution and metabolic and hormonal activities in mice Toxicology 210: 159-167, 2005. Staskal et al Toxicokinetics of BDED47 in female mice; effect of dose, route of exposure, and time. Tox Sci 83: 215-223, 2005. Sjodin et al Retrospective time-trend study of polybrominated diphenyl ether and polybrominated and polychrorinated biphenyl levels in human serum from the United States. Env Health Persp 112: 654-658, 2004. Background Information on Chemicals with hormone action Book I I. General Background 1. de Wit, C.A., An overview of brominated flame retardants in the environment. Chemosphere, 2002. 46: p. 583-624. 2. Birnbaum, L.S. and D.F. Staskal, Brominated flame retardants: Cause for concern? Environmental Health Perspectives, 2004. 112(1): p. 9-17. 3. Darnerud, P.O.; Toxic effects of brominated flame retardants in man and in wildlife. Environment International, 2003. 29(6): p. 841-853. 4. Legler, J. and A. Brouwer, Are brominated flame retardants endocrine disruptors? Environment International, 2003. 29(6): p. 879-885. 5. Vos, J.G., et al., Brominated flame retardants and endocrine disruption. Pure and Applied Chemistry, 2003. 75(11-12): p. 2039-2046. 6. Alaee, M., et al., An overview of commercially used brominated flame retardants, their applications, their use patterns in different countries/regions and possible modes of release. Environment International, 2003. 29(6): p. 683-689. Source: https://www.industrydocuments.ucsf.edu/docs/hzbn0226 INTERAGENCY DRAFT DELIBERATIVE II. Polybrominated Diphenyl Ethers A. PBDE Hormone action 1. Zhou, T., et al., Effects of short-term in vivo exposure to polybrominated diphenyl ethers on thyroid hormones and hepatic enzyme activities in weanling rats. Toxicologic Sciences, 2001. 61: p. 76-82. 2. Zhou, T., et al., Developmental exposure to brominated diphenyl ethers results in thyroid hormone disruption. Toxicological Sciences, 2002. 66: p. 105-116. 3. Stoker, T.E., et al., Assessment of DE-71, a commercial polybrominated diphenyl ether (PBDE) mixture, in the EDSP male and female pubertal protocols. Toxicological Sciences, 2004. 78(1): p. 144-155. 4. Meerts, I.A.T.M., et al., In vitro estrogenicity of polybrominated diphenyl ethers, hydroxylated PBDEs, and polybrominated bisphenol A compounds. Environ. Health Perspect., 2001. 109: p. 399-407. B. PBDE General Exposure information 1. Sjodin, A., et al., Retrospective time-trend study of polybrominated diphenyl ether and polybrominated and polychlorinated biphenyl levels in human serum from the United States. Environmental Health Perspectives, 2004. 112(6): p. 654-658. 2. Hites, R.A., Polyhrominated diphenyl ethers in the environment and in people: A meta- analysis of concentrations. Environmental Science & Technology, 2004. 38(4): p. 945- 956. 3. Petreas, M., et al., High body burdens of 2,2 ,4, 4 -tetrabromodiphenyl ether (BDE-47) in California women. Environmental Health Perspectives, 2003. 111(9): p. 1175-1179. 4. Alcock, R.E., et al., Understanding levels and trends of BDE-47 in the UK and North America: an assessment of principal reservoirs and source inputs. Environment International, 2003. 29(6): p. 691-698. 5. Covaci, A., S. Voorspoels, and J. de Boer, Determination of brominated flame retardants, with emphasis on polybrominated diphenyl ethers (PBDEs) in environmental and human samples - a review. Environment International, 2003. 29(6): p. 735-756. 6. Law, R.J., et al., Levels and trends of polybrominated diphenylethers and other brominated flame retardants in wildlife. Environment International, 2003. 29(6): p. 757- 770. 7. Hale, R.C., et al., Polybrominated diphenyl ether flame retardants in the North American environment. Environment International, 2003. 29(6): p. 771-779. 8. Sjodin, A., D.G. Patterson, and A. Bergman, A review on human exposure to brominated flame retardants - particularly polybrominated diphenyl ethers. Environment International, 2003. 29(6): p. 829-839. 9. Hooper, K. and J.W. She, Lessons from the polybrominated diphenyl ethers (PBDEs): Precautionary principle, primary prevention, and the value of community-based body- burden monitoring using breast milk. Environmental Health Perspectives, 2003. 111(1): p. 109-114. Source: https://www,industrydocuments.ucsf.edu/docs/hzbn0226 INTERAGENCY DRAFT DELIBERATIVE Book II C. Other PBDE biological effects 1. Helleday, T., et al., Brominated flame retardants induce intragenic recombination in mammalian cellsMutation Research. Mutation Research; 1999. 439: p. 137-147. 2. Kemmlein, S., D. Herzke, and R.J. Law, BFR - governmental testing programme. Environment International, 2003. 29(6): p. 781-792. 3. Hakk, H. and R.J. Letcher, Metabolism in the toxicokinetics and fate of brominated flame retardants - a review. Environment International, 2003. 29(6): p. 801-828. 4. Viberg, H., A. Fredriksson, and P. Eriksson, Neonatal exposure to polybrominated diphenyl ether (PBDE 153) disrupts spontaneous behaviour, impairs learning and memory, and decreases hippocampal cholinergic receptors in adult mice. Toxicology and Applied Pharmacology, 2003. 192(2): p. 95-106. 5. Viberg, H., A. Fredriksson, and P. Eriksson, Investigations of strain and/or gender differences in developmental neurotoxic effects of polybrominated diphenyl ethers in mice. Toxicological Sciences, 2004. 81(2): p. 344-353. 6. Chen, G.S. and N.J. Bunce, Polybrominated diphenyl ethers as Ah receptor agonists and antagonists. Toxicological Sciences, 2003. 76(2): p. 310-320. 7. Branchi, I., et al., Polybrominated diphenyl ethers: Neurobehavioral effects following developmental exposure. Neurotoxicology, 2003. 24(3): p. 449-462. III. Tetrabromobisphenol A 1. Meerts, I.A.T.M., et al., Potent competitive interactions of some brominated flame retardants and related compounds with human transthyretin in vitro. Toxicologic Sciences, 2000, 56: p. 95-104. 2. Kitamura, S., et al., Thyroid hormonal activity of the flame retardants tetrabromobisphenol. A and tetrachlorobisphenol A. Biochemical and Biophysica Research Communications, 2002. 293: p. 554-559. 3. Hakk, H., et al., Metabolism, excretion and distribution of the flame retardant tetrabromiobisphenol-A in conventional and bile-duct cannulated rats. Xenobiotica, 2000. 30: p. 881-890. 4. Samuelsen, M., et al., Estrogen-like properties of brominated analogs of bisphenol A in the MCF-7 human breast, cancer cell lines. Cell Biology and Toxicology, 2001. 17: p. 139-151. 5. Brown, D.J., et al., Analysis of Ah receptor pathway activation by brominated flame retardants. Chemosphere, 2004. 55: p. 1509-1518. 6. Hayama, T., et al., Determination of tetrabromobisphenol A in human serum by liquid chromatography-electrospray ionization tandem mass spectrometry. Journal of Chromatography B-Analytical Technologies in the Biomedical and Life Sciences, 2004. 809(1): p. 131-136. 7. Szymanska, J.A., J.K. Iotrowski, and B. Frydrych, Hepatotoxicity of tetrabrombisphenol- A: effects of repeated dosage in rats. Toxicology, 2000. 142: p. 87-95. Source: https://www.industrydocuments.ucsf.edu/docs/hzbn0226 INTERAGENCY DRAFT DELIBERATIVE 8. Inouye, B., et al., Effects of aromatic bromine compounds on the function of biological membranes. Toxicol Appl. Pharmacol, 1979. 48: p. 467-477. IV. Sodium chlorate 1. Hooth, M.J., et al., Subchronic sodium chlorate exposure in drinking water results in a concentatio-dependent increase in rat thyroid follicular cell hyperplasia. Toxicol Pathol, 2001. 29: p. 250-259. Book III V. Hexachlorobenzene 1. National Toxicology Program, Final Report on the 13-Week toxicity study of Hexachlorobenzene. Battelle Columbus, 2001. VI. 3,3',4.'-Tetrachlorazobenzene 1. National Toxicology Program, Final Report on the 13-Week toxicity study of 3,3", 4,4'- tetracloroazobenzene. Battelle Columbus, 2001. VII. Decabromodiphenyl ether - does this chemical break down to lower brominated diphenyl ethers? 1. Stapleton, H.M., R.J. Letcher, and J.E. Baker, Debromination of polyhrominated diphenyl ether congeners BDE 99 and BDE 183 in the intestinal tract of the common carp (Cyprinus carpio). Environmental Science & Technology, 2004. 38(4): p. 1054-1061. 2. Eriksson, J., et al., Photochemical decomposition of 15 polybrominated diphenyl ether congeners in methanol/water. Environmental Science & Technology, 2004. 38(11): p. 3119-3125. 3. Bezares-Cruz, J., C.T. Jafvert, and I. Hua, Solar photodecomposition of decabromodiphenyl ether: Products and quantum yield. Environmental Science & Technology, 2004. 38(15): p. 4149-4156. 4. Watanabe, I. and S. Sakai, Environmental release and behavior of brominated flame retardants. Environment International, 2003. 29(6): p. 665-682. 5. Gouin, T. and T. Harner, Modelling the environmental fate of the polybrominated diphenyl ethers. Environment International, 2003. 29(6): p. 717-724. CDC comments: CDC/ATSDR General Comments: We have very few comments concerning the approach taken for the assessment of the Source: https://www.industrydocuments.ucsf.edu/docs/hzbn0226 INTERAGENCY DRAFT DELIBERATIVE new RfD for BDE-47, BDE-99 and BDE-153. We are happy to see that EPA is now basing the risk assessment to a large extent on the work of Erikson and co-workers as the most sensitive endpoint of PBDE exposure, while at the same time describing in an objective manner the limitations of these studies. Page 1, line 3 in the BDE-153 document: At this location please change BDE-99 to BDE-153. Source: https://www.industrydocuments.ucsf.edu/docs/hzbn0226 DBT YYETTTTYYYYYE John Bob Benson/P2/R8/USEPAJUS@EPA, Mary 4 /andenberg/DC/USEPA/US To Manibusan/DC/USEPA/US@EPA, Amy 4 G 02/07/2006 02:34 PM Mills/DC/USEPA/US@EPA, Karen [email protected], George CC Alapas/DC/USEPA/US@EPA bcc Subject Interagency/OMB comments on Draft IRIS assessment of Dibutyl Phthalate Please see below for a number of specific comments from CDC and also OMB, it is possible other comments from CPSC will be provided later. In general, I see many technical edits and corrections, with a few bigger issues as well (e.g., the comments on pages 74-85). Our approach to these interagency comments (for perc and dichlorobenzenes) has been to carefully evaluate the comments and to develop a response to comments document. I recommend you create a document that addresses each comment (include their "comment" and our "responses" as one file) and provide a point-by-point evaluation. I encourage that the tone of our 'responses' be thoughtful and that we make such changes as we deem warranted. If there are some larger science-policy issues or points made where it is unclear how to respond, then flag these for discussion. Please give me a sense of the time it may take you to respond to these comments (l'd expect a few weeks). Thank you for all your hard work on this document, it seems we'll soon be able to move ahead! John John Vandenberg Associate Director for Health National Center for Environmental Assessment B243-01 Office of Research and Development, USEPA Research Triangle Park, NC 27711 DC Research Triangle Park, NC Tel: 202 564 3407 919 541 4527 Fax: 202 565 0090 919 541 5078 Forwarded by John Vandenberg/DC/USEPA/US on 02/07/2006 02:21 PM U "Beck, Nancy" <[email protected] To John Vandenberg/DC/USEPA/US@EPA CC Peter Preuss/DC/USEPAJUS@EPA 02/07/2006 09:50 AM Subject RE: Draft IRIS assessment of Dibutyl Phthalate OMB come - sim to OMB rags -precursor events d addensity. Reduced testosterme. Biochem. change. -moa ril to humans'. EAg. trad'y assumes relevance). (Hormone) (unat level in redent rul. to clinical link to change. - concerdance (need epi data?) ( -precursor effects OK vi2 camen glines ) - where's data coming from-rodent only ? Source: https://www.industrydocuments.ucsf.edu/docs/hzbn0226 Hi John, Attached are agency comments on the draft. Its possible CPSC may have some comments as well, but here are some to get you started. Please let me know if you would like to talk through EPA responses to comments or if EPA will provide a written response. I'm happy to answer and questions and. facilitate any needed dialogue with CDC as well. Otherwise, we will look forward to seeing a revised draft and responses to comments. Many thanks, Nancy Original Message From: [email protected] [mailto:[email protected]] Sent: Friday, December 02, 2005 12:34 PM To: Beck, "Nancy Cc: [email protected];[email protected] [email protected] Subject: Draft IRIS assessment of Dibutyl Phthalate Hi Nancy, Here is the next draft IRIS assessment for you to look at (if you want!) . Attached is the draft dibutyl phthalate tox review and draft charge questions. This has been developed within the agency and has completed intra-agency review by the IRIS reviewers. It has not been shared with other agencies and we are not aware of any particular interest by other agencies. Our plan is to announce the availability of the document in the FR and have the document externally reviewed through a panel review (organized and managed by a contractor, timed to allow public comments to be provided prior to panel meeting) Let me know if you have any questions about the dräft. Thanks; John (See attached file: Charge DiBP ext peer review3. wpd) (See attached file: Tox R DiBP ext peer review2.wpd) John Vandenberg Associate Director for Health National Center for Environmental Assessment B243-01 Office of Research and Development, USEPA Research Triangle Park, NC 27711 DC Research Triangle Park, NC Tel: 202 564 3407 919 541 4527 Fax: 202 565 0090 919 541 5078 Dibutyl PhthalateAgencycomments.dod Source: https://www.industrydocuments.ucsf.edu/docs/hzbn0226 Interagency Draft Deliberative February 6, 2006 (there may be more comments coming from CPSC) CDC Comments Page 6, 2nd paragraph, 2nd sentence: It needs to be mentioned that there are esterases in some biological matrices, including amniotic fluid, saliva, and breast milk, that could hydrolyze DBP to MBP. Therefore, MBP could be detected in some tissues as a result of contamination with DBP that it is hydrolyzed to MBP by esterases. Page 7, section 3.2: The Silva et al., 2003 ref (2nd line of 1st paragraph) doesn't have rats data: It should be deleted. Last sentence of paragraph: It is not that the omega and omega-1 oxidation products of MBP were not detected, but that they were not measured. The sentence should be rewritten: Monobutyl phthalate and monobutyl phthalate glucuronide have been found in human blood and urine, but the products of omega and omega-1 oxidation have not been MEASURED (Silva et al., 2003). Page 8, Figure 1: The correct name of the structure at the bottom right of the scheme is: 3- carboxypropyl NOT 4-carboxypropyl Page 9, 1st paragraph: The concentrations reported in the draft from the Silva et al., 2003 paper are MEDIAN, not mean (as stated). Also, indicate the number of human samples-analyzed: 283. Page 16,2nd paragraph, line 7: As written, it appears that in the Silva et al., 2003 paper the concentration values 14.4 and 4.2 were given. However, this statement is incorrect: The value 14.4 was given in Silva et al., 2003 (Table 2 of the manuscript). The value of 4.2 was not. If this value was calculated by EPA from data provided in Silva et al., 2003, this should be clearly indicated. Page 16, 2nd paragraph, line 4: The presence of MBP in tissues other than urine could come, at least partially, from the hydrolysis by esterases present in the tissues of the ubiquitous DBP introduced in the sample during sampling or storage. Furthermore, the concentrations of MBP in tissues/fluids other than urine in humans are relatively ow.when compared to urinary concentrations. For these reasons, urinary data may be more reliable than serum data for MBP: higher MBP concentrations in urine than in serum, and minimal esterase activity in urine compared to serum. Urine, however, unlike blood/serum, is a non-regulated fluid, so dilution of urine due to hydration status may complicate calculations. Page 17, 2nd paragraph: The Calafat et al. (2005) reference (in press at the time the draft was written) has been published. The correct citation is Calafat et al. (2006): Calafat, A.M., Brock, J.W., Silva, M.J., Gray, L.E., Reidy, J.A., Barr, D.B., Needham, L.L., 2006 Urinary and Amniotic Fluid Levels of Phthalate Monoesters in Rats after the Oral Administration of Di(2-ethylhexyl) Phthalate and Di-n-butyl Phthalate. Toxicology 217, 22-30. This citation can also be updated in page 90 (reference list) Source: https://www.industrydocuments.ucsf.edu/docs/hzbn0226 Interagency Draft Deliberative Page 19, 1st line: Colon et al. (2000) didn't measure monobutyl phthalate in serum. They measured the parent compound, dibutyl phthalate (DBP). Therefore, the reference to this study should be deleted. Page 19, 2nd paragraph: Data from NHANES 2001-2002 are available at vww.cdc.gov/exposurereport/, so Table 3-5 could be updated to also include these data. Page 19, 2nd paragraph: In CDC's publication using the NHANES 1999-2000 data (Silva et al, 2004a), it was shown that women of reproductive age (30-39 years old) DID NOT have higher concentrations of MBP than younger or older women. This is shown in Figure 4 of the Silva et al., 2004a paper. This finding is not mentioned in this draft and it should, especially because the draft does mention the findings from the NHANES III dataset in the 1st paragraph of this page regarding pregnant women. Page 21: The calculation of the estimated dose conducted by Kohn et al. in 2000, used the phthalates NHANES III dataset, which was NOT representative of the U.S. population. Therefore, in page 21, the 7 microg/Kg-day dose for the general U.S. population was taken from 192 individuals and the 32 microg/kg-day for U.S. women of childbearing age was taken from only 97 women. I think here it would be a good place again to indicate the estimated exposure from the NHANES 1999-2000 and NHANES 2001-2002 data. Page 24, last line of 1st paragraph: Specify that the NHANES samples are from NHANES 1999-2000. Page 67, 1st paragraph, 3rd line: Delete Silva et al. 2003. In this manuscript no attempt was made to measure analytes other than MBP. Page 67, 4th paragraph: Rewrite sentence as follows: Two studies have documented an association between some adult human semen measures with exposure to dibutyl phthalate (Murature et al., 1987) and phthalate monoesters (Duty et al., 2003a). Page 89, end of 1st paragraph: There is only one study that suggests that "the 95th percentile for the general population is approximately 7 g/kg-day and for women of childbearing age approximately 32 g/kg-day." Insert the Kohn et al. 2000 reference at the end of the last sentence of the paragraph: this will indicate to the reader the source of the data. I would also suggest that the dose is calculated for the U.S. general population and for women of childbearing age using the NHANES 1999-2000 data presented in Silva et al. 2004a. The phthalates NHANES 1999-2000 and 2001-2002 were representative of the general U.S. population, the NHANES III dataset was not. OMB Comments Page 1 and throughout- please use original, not 2002 recommended RfD definition. Page 5, the Anderson 2001 study is referred to as being 'conducted with an ethically approved protocol'. Please clarify in the text what it is that this means. Source: https://www.industrydocuments.ucsf.edu/docs/hzbn0226 Interagency Draft Deliberative Page 9, in discussing Silva 2003 and elimination, the text should state what the dose (exposure) was otherwise the urine value is not informative regarding elimination rates. Page 14 states: "Although a completed physiologically based pharmacokinetic model for both the rat and human is not yet available, it might be possible to use other data to provide an estimate of the relative exposure of the rat and human fetus to the toxicologically active metabolite, monobutyl phthalate, during the critical window for development of the male reproductive tract. Information on relative exposure could be used to inform the selection of the interspecies uncertainty factor used to derive a reference value." These statements are very broad. What is meant by "other data" and in 1st sentence? In the 2nd sentence how might relative exposure information be used to inform an UF? Its not clear how UF's take relative exposure into account-do you mean organ specific internal dose? Page 15, how significant is the variability of monobutyl phthalate glucuronide, as discussed in Silva 2003? Page 17, for monobutyl phthalate, the range of partition coefficients is 1.9-2.8. Is there a citation for this? Its not clear where the numbers come from. Page 18, plots from Kremer 2005a are referred to. This citation is only an abstract. Did it really contain plots? Page 19, please state that the 289 samples from Blount, although part of NHANES, should not be considered to be representative as it is not a full NHANES dataset. Page 19, table 3-5 is confusing. Its not clear what data is being referred to-is it from the Blount study or Silva or DHHS? Also it would be useful to know if the values are for males or females or both. Page 20/21, its not clear at all where the values of 7ug/kg for a 95th percentile and 32 ug/kg for US women comes from. Please clarify. This is very confusing. Also, is the 32ug/kg data a mean or a 95th percentile? Page 22, please state whether or not the decrease in mean sperm density seen in Murature was statistically significant? Page 22, please state the sample size for the comparison group in Duty et al. Page 23, in discussing Duty, 2004, it says the dose response was "suggestive negative'. Please clarify what this means-was it not statistically significant? Page 26, please state whether or not the associations with enzyme levels in Fukuoka and the decreases in Zhou were statistically significant. Source: https://www.industrydocuments.ucsf.edu/docs/hzbn0226 Interagency Draft Deliberative Page 28, in discussion of Fukuoka please state whether or not changes in testicular fructose and glucose were statistically significant. Also, what may explain the fact that blood concentrations did not change? Is this to be expected? Page 35, why are no NOAELs and LOAELs provided for the Gray study? Page 43, a NTP 2002 abstract is referred to. Is there no final report to update these data? Page 54, refers to a weight of evidence pointing to a dec. in testosterone in leydig cells. Where is this weight of evidence coming from? Its not clear what studies are being referred to here as the 2 most recently cited studies in the text are both abstracts. Page 61, its not clear where or how the studies in 4.3.2 clearly show that monbutyl phthalate is responsible for the toxic effect. Please clarify the reasoning behind this. Page 66, states that Dibutyl phthalate is metabolized to monobutyl phthalate and n-butanol. How come n-butanol is never mentioned in section 3.2? Page 68, please insert the language in bold in the following 2 sentences: There are extensive studies documenting developmental toxicity of dibutyl and monobutyl phthalate in rodents. A number of studies have examined gene expression for the enzymes involved in steroid biosynthesis in rodents. Page 69, discussion of MOA should be clear that this is for rodents. Also, there seems to be no discussion about the relevance of this in humans. Is it known that the pathways in humans are the same and that levels of hormones and hormone reserves are similar? Page 72, please clarify that this is a proposed MOA in rodents. Also in the figure suggest saying that reduced testosterone and dihydrotestoterone can result in Also reduced Ins3 may result in unless all these effects are proven-although the language in the text makes it sound as though causality is possible but not known with certainty. Also in the figure its not clear if the MOA is for the testis or leydig cell? Page 74, why is the decrease in testosterone levels throughout the document referred to as a NOAEL and LOAEL? Isn't it really an NOEL? this should be changed throughout the document (page 85 etc) Even the Lehmann paper itself talks about a NOEL and a LOEL. Page 75 is clear that this is not an adverse effect but is a precursor for all other effects. Is it clear that all adverse developmental effects stem from the decrease in testosterone? From figure 2 it seems as though Ins3 effects are independent of testosterone. Page 74, is there a developmental effect in humans that is predicted by retained areolas or nipples in the male fetus? Has EPA relied on this endpoint before? Page 75, in perchlorate there is a precedent for regulating based on an upstream precursor effect in humans. However, here EPA is using a precursor effect in rats. A discussion of how Tevels of testosterone in humans and rodents may be similar in levels, reserves, metabolism, or Source: https://www.industrydocuments.ucsf.edu/docs/hzbn0226 Interagency Draft Deliberative stores is not provided at all. In order to justify using this endpoint, EPA needs- to discuss this thoroughly and there needs tó be strong evidence that pathways and regulation in humäns and rodents, not just for testosterone but also for dibutyl phthalate metabolism are similar. Page 75, its not clear how the effect could be due to a single exposure. Text cites Carruthers and Foster, which was a multiday exposure, Thompson was an abstract only which used a 2 day exposure, and its not clear what in EPA 1991 is being referred to. The Developmental guidelines are getting pretty old and the endpoint of changes in hormone levels is not even referred to in this document-the guidelines do not discuss whether or not exposure to a precursor on a single day could justify an adverse effect. Page 76, figure 3 and 4 should be made more clear. It would be helpful to perhaps break these into 2 arrays-one showing responses in the 0-400 range and the other showing higher levels. The resolution at the low exposures is what is important here and it is lacking most. Also please be clear about which effects are not adverse. Page 79, regarding the # notation, please see the comments for page 75 regarding the exposure window. Page 85, in table 5-4, why is BMDL 1SD shown? Its not clear why this endpoint was chosen. Page 85, there is discussion as to why the BMD approach was not used and this seems to depend on limitations of the study (position in litter was not considered, gender effects, etc). How do these limitations affect the confidence in the NOEL? It seems that they likely lead to an increase in variability. Also this section is the first time the biological significance of testosterone changes is mentioned. Shouldn't there be more discussion of the levels required for significance in the MOA section of the chapter? Page 86, see comment on page 75 regarding single exposures. Suggest deleting this sentence. Page 87, its not clear why there is a discussion in the database UF section that is talking about the lack of cancer bioassays and the mode of action for tumors. Suggest deleting this language. Page 87, its not clear that the data support an acute, short term, or subchronic RfD. Discussion is not sufficient to support this (see comment regarding page 75). Page 88, besides the old RfD, are there any other safety valués in existence (ATSDR or CALEPA or other?). It would be useful to mention these. Page 89, please change NOAEL to NOEL; please clarify where 7 and 32ug/kg come from and discuss how representative they are; why is the confidence high when there are no human developmental or reproductive data-how dose data in 7 animals translate to high confidence for the RfD? B-1, is it normal to use a nested model? What does this imply about the data? Source: https://www.industrydocuments.ucsf.edu/docs/hzbn0226 Interagency Draft Deliberative B-5, Were the data used based on the F1 litter 3 or results from all 5 litters analyzed together? editorial comments: Page 16- Saliva 2005 should be Silva 2005 Page 17- in discussing the boron assessment, the ref given is to the cancer guidelines, which does not seem correct Page 19- refers to "thelarche", do you mean "menarche"? Page 44- refers to a 10,000ppm:0ppm exposure group. Is this a common way to describe this treatment group? Other comments: What expertise will EPA have on the review panel? How many reviewers in each area? Has EPA set an RfD before based on a precursor effect in rodents? Based on retained nipples? The charge should be modified to reflect that there is no discussion of an RfC or quantitative cancer assessment IfEPA continues to rely on the NOEL, the charge will have to have some questions asking about relevance of this precursor to humans, MOA in humans, whether or not this is adverse and at what levels, whether or not this prevents all developmental effects, etc. Source: :ttps://www.industrydocuments.ucsf.edu/docs/hzbn0226 comments from OMB (Mango Sthwab) 4-19-05 Comments on the Toxicological Review of Toluene (Feb 2005 draft) General Comments on RfC 1. Clarity: We suggest improving the clarity of presentation for both this document and the actual IRIS entry file. Specifically, the document reads like a hybrid of the old focus on "color vision" and the new focus on a suite of "neurological effects." We suggest a stronger first paragraph that reviews the potential options for the critical endpoint and clearly states that you are using an array or suite of effects, considered together as the critical endpoint. The reasons EPA determined it makes sense to use a suite of endpoints should be more clearly stated here as well. The detailed comments below provide additional comments designed to help improve e the clarity of the document. 2. Description of the Methods Used: The "Weight of Evidence" method should be clearly explained before presenting the results (although a weight of evidence approach is common for hazard ID, but not for dose-response, thus the need for an explanation). The actual criteria that are used should be described as well. See comments below for page 75. Some confusion might be due the apparent disconnect between the usual use of "weight of evidence," which describes an approach which weighs all of the evidence, versus it use here to describe a method of classifying available studies based on adequacy. It may be better to describe the choice of the critical endpoint as based on "weight of evidence" approach rather than the choice of the principal study. That is, EPA reviewed all of the studies, and determined that as a whole they present evidence of the potential for neurological effects. However, in determining a point of departure, EPA selected a subset of the highest quality studies to determine an "average" or "typical" level of effect. 3. Transparency with Respect to the Limitations of the Methods: We suggest adding discussions that clearly lay out the limitations/caveats/concerns and utility associated use of both 1) a suite of neurological endpoints as the critical effect and 2) an average or typical metric as the point of departure. Both of these discussions would provide risk managers with the information that they need to understand what she/he is protecting against when they use this RfC. With respect to the former, the discussion could be added to the paragraph that initially introduces the use of a suite of endpoints. The added discussion should highlight (based in part on peer reviewers comments) that some of these neurological endpoints may not actually be "adverse" and others may exhibit fairly high baseline population variability. With respect to the latter, use of an average point of departure from a group of studies) that are not strong enough in and of themselves begs the question as to meaning of the relationship being described. The reader needs some guidance as to what it means to 1 Source: https://www.industrydocuments.ucsf.edu/docs/hzbn0226 be "above" or "below" this number since it is not a simple NOAEL or BMD. Perhaps it would be helpful to explain it as a range: "we expect the NOAEL for this suite of neurological effects to be between X and y ppbs. Then go on to explain that you are using the average as a surrogate because of the instability of each of the individual numbers (given both EPA's and the peer reviewer concerns about utility of the individual studies). Perhaps you can show how sensitive the average is to the inclusion of certain studies or the similarity of the average with the use of specific principal studies. Specific edits re: RfC section: pg 73, 1st paragraph, line 2: documentation of the "developmental effect in newborn children" is not provided in the prior literature review. pls add cites to the "numerous cases" or delete pg 73, 2nd paragraph, end of second sentence add "for individual neurological effects" pg 73, 2nd paragraph, fourth sentence: add "at least one of the following neurological effects" between "on" and "color vision, auditory evoked " pg 73, 2nd paragraph, last sentence: it is not clear what the connection is between the two parts of the sentence. Should the Campagna et al 2001 study be cited in with the lower exposure studies at the beginning of the paragraph? Also, isn't this the same thought that is in the second sentence of the next paragraph? pg 73, 3rd paragraph, second line, add "have" between "or" and "inadequate" (or change it to "do not have adequate"). pg 74, paragraph beginning on prior page: rework 1st sentence on page to focus on the key point: "For example, the study that showed effects at the lowest level of exposure (i.e., color vision at 8 ppb) included individuals who had substantial exposure to compounds other than toluene (Compagna et al. 2001). pg 74, paragraph beginning on prior page: how does this sentence relate to the theme re: confounding? are you implying that effects were not found due to confounding? If this is so, say so and present the specific ways in which these studies were confounded that the positive studies were not. The sentence, as is, however, could just be moved to the end of the prior paragraph (it would provide the balance to the positive studies listed there.) pg 75, line 2, insert "the potential for" or "the relationship between" after the phrase "evidence indicating" pg 75, line 3: see comment above re: term weight of evidence. Since this is the first place this concept is introduced, please clearly define the method used to review and categorize the literature here. pg 75, 1stfull paragraph: please define the basis for determining "adequacy" here - lay out the criteria that used. 2 Source: https://www.industrydocuments.ucsf.edu/docs/hzbn0226 pg 75, 2nd full paragraph: suggest not using the term "discounted" (either here or in the subsequent paragraphs and summary document) because a weight of evidence approach weighs ALL of the evidence. It does not "discount" studies. It does give more weight to stronger studies, but the way the term is being used in this and subsequent pages, it implies the studies were not included. A more appropriate way of explaining would be to describe why lesser weight was given to certain studies (e.g., lower quality or strength, etc). Table 2: Suggest a more balanced presentation in which highlights both the positive and negative results from the 10 studies are presented - that is, if several endpoints were explored, it is inadequate to just present the positive results given the impact of problem of multiple comparisons on the statistical significance of findings. Some of the information appears to be in the tables, perhaps it is an issue of re-labeling the columns? Pg 81: 1st paragraph, line 2: not sure why effects other than neurological are being discussed here within the context of the "principal study" given that principal effect has been determined (this whole paragraph seems misplaced - perhaps it belongs as part of the first paragraph on page 72?) Pg 81: 2nd and 3rd paragraphs, and the 1st paragraph on the next page: all three of these paragraphs discuss, on deficits in visual perception, but the context for that discussion is not clear - since the "critical effect" is now a suite of neurological effects, please indicate why one set of effects is discussed. Comments on the RfD - It is unclear why the UF of 3 for data base sufficiency is necessary, especially given peer reviewer comments to the contrary. - If the UF is 3000, it is unclear how the confidence could be "medium" 3 Source: https://www.industrydocuments.ucsf.edu/docs/hzbn0226 December 30,2003 Summary of OMB comments and EPA responses - External review draft of the Toxicological Review of Toluene (December 2003) Prepared by Lynn Flowers, chemical manager for toluene OMB comment #1: There is concern about precedent being set by using color vision as a critical endpoint and a related concern that there is not sufficient reviewer expertise to address this, particularly the biological relevance. Specific comments included: -Are there appropriate reviewers to look at this? -Only 50% of reviewers on previous panel were ok with this and one of these reviewers did not think documentation was sufficient. -Others asked for increased discussion on biological relevance. This still seems to be missing from the draft. -The added reviewer with this expertise is an author whom EPA cites for having used this test for environmental relevance in the past, thus he may not be seen as an unbiased reviewer. -The charge question 2b should directly ask "Is this effect biologically relevant"? This would mean there needs to be experts on the panel that can answer the question. Reviewers from the previous panel sounded like they could not and these same reviewers are on the panel again. EP. A response: The peer review contractor is trying to find another color vision expert and has contacted the panel members with neurotoxicity expertise to inquire about their capability to review/comment on color vision. Additional discussion on the choice of color vision as the critical effect and biological relevance of this endpoint has been added to Section 5.2.1 of the Toxicological Review. The charge question (2b) has been clarified as follows: "The critical effect is identified as impaired color vision. Is this the correct critical effect and is it adequately described? Is the biological basis for choosing this effect adequately explained?" OMB comment #2: Appendix A is unclear in that all reviewers agreed with the RfD principal study, yet it was changed anyway. Reads as very contradictory and needs to be clarified. Uncertainty factor discussion needs to be clarified. EP. A response: The rationale for the change in the principal study for the RfD has been clarified in Appendix A to better explain that additional key studies were identified as a result of public comment. The discussion on the application of uncertainty factors to the point of departure for the RfD has been corrected. OMB comment #3: It is unclear why kidney weight changes are used instead of liver weight changes or in addition to liver changes. This is not explained well (especially considering distribution of toluene in the body). EPA response: The rationale for selecting kidney weight changes as the critical effect for the derivation of the RfD has been further clarified in Section 5.1.1 of the Toxicological Review. Source: https://www.industrydocuments.ucsf.edu/docs/hzbn0226 OMB comment #4: It is unclear if discussion of immunological studies belongs in Section 1.A.2 or 1.A.4 of the IRIS summary. EPA response: The discussion of immunological effects from toluene exposure has been moved to Section 1.A.4 of the IRIS Summary. OMB comment #5: Use of male rat data instead of male and female data for the RfD does not appear to be supported well, especially considering Section 4.7.2 of the Toxicological Review. If both sexes were used, how different would the value be? EPA response: Male rat data were used for the derivation of the RfD. The response in male rats was greater than that seen in female rats as indicated in Section 4.2.1.1 of the Toxicological Review. As indicated in Section 4.7.2, male rats and mice have been shown to be more sensitive, in general, to the effects of toluene than females. Thus, the use of data from male rats is supported by the available studies. Source: https://www.industrydocuments.ucsf.edu/docs/hzbn0226 John Vandenberg/DC/USEPA/US mYYYYYYYY John Vandenberg/DC/USEPA/US G To Peter Preuss/DC/USEPA/US@EPA, Lynn 4 A 09/13/2004 10:39 AM Flowers/DC/USEPA/US A to CC George Alapas/DCIUSEPA/US@EPA, Amy Mills/DC/USEPA/US@EPA Subject naphthalene - OMB request for briefing Nancy Beck called me this morning and conveyed several things: 1) John Graham wants a briefing on the naphthalene assessment, focused on process from here (e.g., interagency review, consideration of peer review comments). We should arrange in next couple of weeks if possible. 2) She (Nancy) considers some of the external peer review comments to be significant. 3) they've heard a rumor we plan to have the document out by end of September. I told her we're evaluating the draft in light of peer review comments, that we've heard DOD plans to comment but we have not received any commentsfrom them and I urged her to get them to share their comments. I sketched out the IRIS process insofar as it would normally proceed, noting that a formal interagency review would change the process (and that we'd share a document that reflects our revisions following external peer review). I mentioned IRIS Track (Paul Gilman had also mentioned it, they're interested in seeing it). 1 didn't give any specific dates to her (perhaps fortunately IRIS track was offline this morning!) We should talk through how we want interagency review to occur, including any groundrules we want to get set up front to avoid paralysis (e.g., fixed time for other agencies to provide review comments; final disposition/decisionmaking by EPA/ORD on assessment document completion; criteria or conditions calling for additional external peer review). Especially for "biggies" that have interagency review we need to stake out a process that will lead us to be successful in terms of timeliness, clarity, consistency, etc. John John Vandenberg Associate Director for Health National Center for Environmental Assessment B240-01 Office of Research and Development, USEPA Research Triangle Park, NC 27711 DC Source:https:/www.industrydocuments.ucsf.edu/docs/hzbn0226 John Amy Mills/DC/USEPA/US@EPA, [email protected], Vandenberg/DC/USEPA/US To George Alapas/DC/USEPA/US@EPA, Bettyjo 4 G 05/24/2005 02:52 PM Overton/DC/USEPA/US@EPA, Linda A CC bcc Subject IRIS process comments from OMB, next steps In brief, Nancy Beck (and, she says, Dr. Graham) were expecting more detail than provided in the flow chart and 2-pager to address the 'details'. I pushed back, not wanting to have us wait several months to develop new SOPs, as this is premature. Nancy seemed to concur, though she is checking with Dr: Graham. We ended up agreeing to slightly revise the 2-pager to add a bullet on next steps (i.e., public workshop to discuss process and details/issues) and to emphasize or elaborate on the improvements the process will bring. I've discussed these changes with Amy and she'll revise the 2-pager sent to OMB in preparation for Amy Farrell. Nancy will send over her comments by fax by tomorrow (to DC office, BettyJo - please keep an eye out for this and give copies to addressees here). Further, I agreed that in our Federal Register notice announcing the workshop, we'll identify some of the topics and issues for discussion including, for example, the attribution of comments to specific reviewers, the criteria for selection of QA Check reviewers, the proposal with respect to a NAS risk assessment panel, the availability of relevant information on web sites, etc. OMB wants to review this FR notice. I emphasized the FR notice will not be exhaustive on what issues will be raised and discussed at the workshop but it will be sufficiently illustrative to inform potential participants as to the details that we will likely seek input on. We discussed Interagency review and I informed her perc was soon to arrive for interagency.review (estimate about a month from now). She clearly is concerned that OMB/OSTP have not worked out a plan for interagency review. I offered that we could help in getting materials prepared for the review process, but it is essential that the request for review come from OMB/OSTP. She asked that the bullet on interagency review refer to EOP rather than "OMB and OSTP will manage interagency review". Next steps: 1) Amy will revise 2-pager and look also at Nancy's comments to see if any final changes are needed before 2-pager and flowchart are sent to Amy Farrell 2) l'll send a note to Amy Farrell noting that we've discussed with OMB and expect to make final draft revisions to information by end of this week and offer to brief her 3) George, please send (or have BettyJo send) revised 2-pager and flow chart to Amy Farrell later this week. 4) Linda, Amy and IRIS staff should initiate or continue FR development and workshop planning. John John Vandenberg Associate Director for Health National Center for Environmental Assessment B243-01 Office of Research and Development, USEPA Research Triangle Park, NC 27711 DC Research Triangle Park, NC Tel: 202 564 3407 919 541 4527 Fax: 202 565 0090 919 541 5078 a Source: https://www.industrydocuments.ucsf.edu/docs/hzbn0226 OSD-AIL" To Peter Preuss/DC/USEPA/US@EPA <[email protected]> "Beck, Nancy" <[email protected]>, "Noe, Paul 02/02/2006 10:18 AM R." <[email protected]>, "Beehler, Alex, Mr, OSD-ATL" <[email protected]>, John Vandenberg/DC/USEPA/US@EPA, "Richard Wickman ([email protected])" <[email protected]>, "Bill McGovern ([email protected])" <[email protected]>, "Blaine Rowley ([email protected])" <[email protected]>, Carl Ma <[email protected]>, "Dave Belluck ([email protected])" CC <[email protected]>, "James Leatherwood ([email protected] <[email protected]>, "[email protected]"" <[email protected]>, "Juan Reyes s [email protected]) <[email protected]>, Keith Holman <[email protected]>, "Martin, Mary" <[email protected]>, Mike Savonis <[email protected]>, Paul Atelsek <[email protected]> David Moses <[email protected]> Subject DoD, NASA, DoE comments on IRIS revisions Peter, OSD, NASA and DOE Sr. staff have reviewed ORD's proposed IRIS revisions chart and detailed explanation of some of the boxes and attached are our comments and suggestions. DHS and DOT were not on our last calls due to scheduling conflicts, so I can not assert to what degree they support these comments. I will get you a confirmation on that. What you have attached is a) the flow chart - we added numbers to all the boxes but also retained your numbering of the latter 10 boxes that correspond to your detailed explanation -- and b) an expanded detailed explanation of the boxes that includes, as we discussed, an proposed explanation for every step to help us all achieve clarity and eventually agreement. These inserts and changes were drafted by a committee of federal staff and recorded by Mitretek (so you might see Mitretek identified as a "commentor". All of our insertions or changes are in color and underlined. We suggest that after you look this over that we set up another multi-agency meeting to bring all the interested federal agencies together to discuss the process steps and see if together can reach consensus on the process, understand how or if this effort fits with Dr. Gray's visions for IRIS, and develop a plan for next steps. Please call me if you have any questions or comments. Shannon E. Cunniff Executive Lead, MERIT Special Assistant for Emerging Contaminants the Proposed IRIS Process 012406.ppt Detailed Steps 0202061.doc Source: https://www.industrydocuments.ucsf.edu/docs/hzbn0226

What does each "slice" represent?

lmcn0226

lmcn0226_p6

INDIVIDUAL SPONSOR, An Individual Sponsor.

Proportion of Total 2011 Work by Project Sponsor Each "slice" represents an individual sponsor; shading represents sponsor sector affiliation. Government Education Coalition Industry Other (each sponsor less than 2% of work) Highlighted Sponsors by Sector Affiliation Government Education Coalition Industry Health Canada International Beyond Science and AECOM Environmental Toxicity Estimates Decisions Coalition American Cleaning Protection Agency for Risk (ITER) Nuclear Receptor Institute National Institute Dose Response MOA Coalition American Petroleum for Occupational Assessment Boot Water Environment Institute Safety and Health Camp Research ToxStrategies Air Force Center for Foundation (WERF) Eli Lilly Engineering and the Alliance for Risk Environment Assessment (ARA) Ontario Ministry of Environment Texas Commission on Environmental Quality National Library of Medicine TOXICOLOGI EXCELLENCE FOR RISK AXXESSMENT NON-PROST SCIENCE FOR PUBLIC souce aments

What does the shading represent?

lmcn0226

lmcn0226_p6

SPONSOR SECTOR AFFILIATION, Sponsor sector affiliation.

Proportion of Total 2011 Work by Project Sponsor Each "slice" represents an individual sponsor; shading represents sponsor sector affiliation. Government Education Coalition Industry Other (each sponsor less than 2% of work) Highlighted Sponsors by Sector Affiliation Government Education Coalition Industry Health Canada International Beyond Science and AECOM Environmental Toxicity Estimates Decisions Coalition American Cleaning Protection Agency for Risk (ITER) Nuclear Receptor Institute National Institute Dose Response MOA Coalition American Petroleum for Occupational Assessment Boot Water Environment Institute Safety and Health Camp Research ToxStrategies Air Force Center for Foundation (WERF) Eli Lilly Engineering and the Alliance for Risk Environment Assessment (ARA) Ontario Ministry of Environment Texas Commission on Environmental Quality National Library of Medicine TOXICOLOGI EXCELLENCE FOR RISK AXXESSMENT NON-PROST SCIENCE FOR PUBLIC souce aments

What does ARA stand for?

lmcn0226

lmcn0226_p6

Alliance for Risk Assessment

Proportion of Total 2011 Work by Project Sponsor Each "slice" represents an individual sponsor; shading represents sponsor sector affiliation. Government Education Coalition Industry Other (each sponsor less than 2% of work) Highlighted Sponsors by Sector Affiliation Government Education Coalition Industry Health Canada International Beyond Science and AECOM Environmental Toxicity Estimates Decisions Coalition American Cleaning Protection Agency for Risk (ITER) Nuclear Receptor Institute National Institute Dose Response MOA Coalition American Petroleum for Occupational Assessment Boot Water Environment Institute Safety and Health Camp Research ToxStrategies Air Force Center for Foundation (WERF) Eli Lilly Engineering and the Alliance for Risk Environment Assessment (ARA) Ontario Ministry of Environment Texas Commission on Environmental Quality National Library of Medicine TOXICOLOGI EXCELLENCE FOR RISK AXXESSMENT NON-PROST SCIENCE FOR PUBLIC souce aments

What does WERF stand for?

lmcn0226

lmcn0226_p6

WATER ENVIRONMENT RESEARCH FOUNDATION, Water Environment Research Foundation.

Proportion of Total 2011 Work by Project Sponsor Each "slice" represents an individual sponsor; shading represents sponsor sector affiliation. Government Education Coalition Industry Other (each sponsor less than 2% of work) Highlighted Sponsors by Sector Affiliation Government Education Coalition Industry Health Canada International Beyond Science and AECOM Environmental Toxicity Estimates Decisions Coalition American Cleaning Protection Agency for Risk (ITER) Nuclear Receptor Institute National Institute Dose Response MOA Coalition American Petroleum for Occupational Assessment Boot Water Environment Institute Safety and Health Camp Research ToxStrategies Air Force Center for Foundation (WERF) Eli Lilly Engineering and the Alliance for Risk Environment Assessment (ARA) Ontario Ministry of Environment Texas Commission on Environmental Quality National Library of Medicine TOXICOLOGI EXCELLENCE FOR RISK AXXESSMENT NON-PROST SCIENCE FOR PUBLIC souce aments

Which was the court ordered deadline to issue a final rule on chlorpyrifos tolerances?

yhcn0226

yhcn0226_p0, yhcn0226_p1, yhcn0226_p2

March 31, 2017,, March 31, 2017, MARCH 31, 2017

CEPA disked States Proposal to Revoke Chlorpyrifos Food Residue Tolerances Related Information Basic information on chlorovrifos uses and EPA actions Revised chlorpyrifos human health risk assessment Learn more about food residue tolerances In October 2015, EPA proposed to revoke all food residue tolerances for the insecticide chlorpyrifos. At this time, EPA is unable to make a safety finding as required under the Federal Food, Drug, and Cosmetic Act (FFDCA). We will respond to all comments received on the proposal and make a final decision by March 31, 2017. In November 2016, we revised our human health risk assessment. This revised analysis shows risks from dietary exposure (i.e., residues of chlorpyrifos on food crops) and drinking water. It does not result in a change to our proposal, but after considering the advice of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP), we are modifying the methods used to support that finding. Learn more about the revised human health risk assessment and opportunity to comment on the assessment. Read the proposed tolerance revocation rule. On this page: 1. Why is EPA proposing to revoke all tolerances for chlorpvrifos? 2. What uses of chlorpyrifos are affected by this proposed tolerance revocation? 3. What are the specific concerns associated with drinking water? 4. What are EPA's next steps? 1. Why is EPA proposing to revoke all tolerances for chlorpyrifos? Source: https://www.industrydocuments.ucsf.edu/docs/yhcn0226 In June 2015 EPA indicated its intention to issue a proposed rule revoking tolerances by April 15, 2016, to address previously identified drinking water concerns and in response to a petition from the Natural Resources Defense Council (NRDC) and Pesticide Action Network North America (PANNA). This schedule would have allowed time for EPA to complete its additional analysis, taking into consideration the public comments received on its December 2014 human health risk assessment. On August 10, the 9th Circuit Court rejected EPA's time line, instead ordering EPA by October 31, 2015, to: deny the petition, issue a proposed revocation, or issue a final revocation rule. At that time, EPA did not deny the petition because we were unable to make a safety finding based on the science as it stood. At that time, EPA did not issue a final revocation rule because we had not completed our revised human health assessment and refined drinking water assessment, so certain science issues were still unresolved. Based on the 2014 analysis, EPA could not conclude that the risk from aggregate exposure met the Federal Food, Drug, and Cosmetic Act (FFDCA) safety standard. EPA has determined that safe levels of chlorpyrifos may be exceeded in parts of the United States for people whose drinking water is derived from some small vulnerable watersheds where chlorpyrifos is heavily used. We informed the court, we proposed to revoke all chlorpyrifos tolerances based on the science as it stood. Issuing a proposed revocation provides an opportunity for public input prior to any final decision. The court also required EPA to provide the timeline for a final rule should EPA issue a proposed revocation. The court has extended the deadline for issuing a final rule to March 31, 2017. In November 2016, we revised our human health risk assessment and drinking water exposure assessment for chlorpyrifos that supported our October 2015 proposal to revoke all food residue tolerances for chlorpyrifos. The revised analysis shows risks from dietary exposure (i.e. residues of chlorpyrifos on food crops) and drinking water. 2. What uses of chlorpyrifos are affected by this proposed tolerance revocation? Because tolerances are the maximum residue of a pesticide that can be in or on food, this proposed rule revoking all chlorpyrifos tolerances means that if this approach is finalized, all agricultural uses of chlorpyrifos would cease. Learn more about tolerances. According to USDA data there are approximately 1.2 million crop producing farms in the U.S. EPA estimates that more than 40,000 crop producing farms currently use chlorpyrifos to control a wide range of insect pests. Cost effective alternatives are available to control many of the pests targeted by chlorpyrifos. Some farms growing certain crops (e.g., broccoli, cauliflower, cabbage, citrus, etc.) may be affected more than others by the loss of the use of chlorpyrifos. Learn more about the uses of chlorovrifos. Source: https://wwww.industrydocuments.ucsf.edu/docs/yhcn0226 3. What are the specific concerns associated with drinking water? EPA's 2014 revised human health risk assessment showed the potential for risks in small watersheds with high concentrations of farming where chlorpyrifos may be widely used. The 2014 assessment included a refined drinking water assessment for the Pacific Northwest and the Southeast, but not the entire country. EPA determined that safe levels of chlorpyrifos may be exceeded for people whose drinking water is derived from certain vulnerable watersheds in parts of the United States. EPA completed its refined drinking water assessment in 2016. While this drinking water assessment is more refined than the previous assessments, the results did not identify many areas where potential exposures of concern to drinking water can be ruled out. As a result, this assessment does not significantly alter the conclusions in the proposed rule regarding drinking water exposure and continues to indicate potential exposure to chlorpyrifos. While EPA completes the final rule, anyone who has concerns about contaminants in their public drinking water system should check with their local water utility or state. Local authorities are not required by EPA to test for chlorpyrifos, since EPA has no federal drinking water regulation for chlorpyrifos. However, some local authorities do test for contaminants beyond federal drinking water regulations. 4. What are EPA's next steps? EPA plans to issue a final rule on chlorpyrifos tolerances by the court- ordered deadline of March 31, 2017, after considering comments received on the revised analyses. LAST UPDATED ON MARCH 30, 2017 Source: https://www.industrydocuments.ucsf.edu/docs/yhcn0226

What is the income type of Martha C. Dourson, LLC?

jsbn0226

jsbn0226_p2, jsbn0226_p3

Legal fees., LEGAL FEES

# DESCRIPTION EIF VALUE INCOME TYPE INCOME AMOUNT 7 TIAA-CREF Bond Market R1 Yes $15,001 - None (or less $50,000 than $201) 8 TIAA Access Bond Plus Fund T4 Yes $15,001 - None (or less $50,000 than $201) 9 TIAA-CREF Inflation-Linked Bond R1 Yes $15,001 - None (or less $50,000 than $201) 10 TIAA-CREF Lifecycle 2015 Fund - Premier Yes $1,001 - $15,000 None (or less Class than $201) 11 North American Flame Retardant N/A Consulting fees $10,000 Association (protection of lives and property from fire) 12 Mercatus Center, George Mason University - N/A Hononarium $500 June 28, 2016 13 "Messiah's Star (Evidence for Faith) (Volume N/A None (or less 1)," CreateSpace Independent Publishing than $201) Platform (value not readily ascertainable) 14 "The Beginning: Let there be light (Evidence N/A None (or less of Faith) (Volume 2),' CreateSpace than $201) Independent Publishing Platform (value not readily ascertainable) 15 "The Linen Cloths: Jesus left behind N/A None (or less (Evidence of Faith) (Volume 3), CreateSpace than $201) Independent Publishing Platform (value not readily ascertainable) 3. Filer's Employment Agreements and Arrangements # EMPLOYER OR PARTY CITY, STATE STATUS AND TERMS DATE 1 University of Cincinnati, State Teachers' Cincinnati, Ohio I will continue to participate in this defined 8/2015 Retirement System (OHIO) contribution plan. The plan sponsor will not make further contributions after my separation. 2 University of Cincinnati, TIAA-CREF Cincinnati, Ohio I will continue to participate in this defined 8/2015 contribution plan. The plan sponsor will not make further contributions after my separation. Source: https://www.industrydocuments.ucsf.edu/docs/jsbn0226 4. Filer's Sources of Compensation Exceeding $5,000 in a Year # SOURCE NAME CITY, STATE BRIEF DESCRIPTION OF DUTIES 1 University of Cincinnati Cincinnati, Ohio As a professor I am responsible for leading research into the safety of a variety of chemicals, improving methods for assessment and educating students, other scientists and the general public on risk issues. 2 Toxicology Excellence for Risk Assessment Cincinnati, Ohio As the Director and President, I was responsible for leading research into the safety of a variety of chemicals, improving methods for assessment and educating other scientists and the general public on risk issues. 3 North American Flame Retardant Washington DC, As a member of a diverse science advisory committee, I was responsible Association District of for advising NAFRA on risk issues associated with flame retardant Columbia chemicals and publishing relevant research. 5. Spouse's Employment Assets & Income and Retirement Accounts # DESCRIPTION EIF VALUE INCOME TYPE INCOME AMOUNT 1 Martha C. Dourson, LLC (solo law practice in N/A $15,001 - Legal fees probate and estates) $50,000 6. Other Assets and Income # DESCRIPTION EIF VALUE INCOME TYPE INCOME AMOUNT 1 Red River Gorgeous, LLC, residential real N/A $50,001 - Rent or $1,001 - $2,500 estate (Stanton, Kentucky) $100,000 Royalties 2 Tomlinson, Dourson and Culler, a General N/A $50,001 - Rent or $201 $1,000 Partnership owning farmland (Lucas, Ohio) $100,000 Royalties 3 U.S. federal credit union (cash accounts) N/A $50,001 - None (or less $100,000 than $201) 4 U.S. financial institution (cash accounts) N/A $1,001 - $15,000 None (or less than $201) Source: https://www.industrydocuments.ucsf.edu/docs/jsbn0226

What is the income type of Red River Gorgeous, LLC. ?

jsbn0226

jsbn0226_p2, jsbn0226_p3

RENT OR ROYALTIES, Rent or Royalties.

# DESCRIPTION EIF VALUE INCOME TYPE INCOME AMOUNT 7 TIAA-CREF Bond Market R1 Yes $15,001 - None (or less $50,000 than $201) 8 TIAA Access Bond Plus Fund T4 Yes $15,001 - None (or less $50,000 than $201) 9 TIAA-CREF Inflation-Linked Bond R1 Yes $15,001 - None (or less $50,000 than $201) 10 TIAA-CREF Lifecycle 2015 Fund - Premier Yes $1,001 - $15,000 None (or less Class than $201) 11 North American Flame Retardant N/A Consulting fees $10,000 Association (protection of lives and property from fire) 12 Mercatus Center, George Mason University - N/A Hononarium $500 June 28, 2016 13 "Messiah's Star (Evidence for Faith) (Volume N/A None (or less 1)," CreateSpace Independent Publishing than $201) Platform (value not readily ascertainable) 14 "The Beginning: Let there be light (Evidence N/A None (or less of Faith) (Volume 2),' CreateSpace than $201) Independent Publishing Platform (value not readily ascertainable) 15 "The Linen Cloths: Jesus left behind N/A None (or less (Evidence of Faith) (Volume 3), CreateSpace than $201) Independent Publishing Platform (value not readily ascertainable) 3. Filer's Employment Agreements and Arrangements # EMPLOYER OR PARTY CITY, STATE STATUS AND TERMS DATE 1 University of Cincinnati, State Teachers' Cincinnati, Ohio I will continue to participate in this defined 8/2015 Retirement System (OHIO) contribution plan. The plan sponsor will not make further contributions after my separation. 2 University of Cincinnati, TIAA-CREF Cincinnati, Ohio I will continue to participate in this defined 8/2015 contribution plan. The plan sponsor will not make further contributions after my separation. Source: https://www.industrydocuments.ucsf.edu/docs/jsbn0226 4. Filer's Sources of Compensation Exceeding $5,000 in a Year # SOURCE NAME CITY, STATE BRIEF DESCRIPTION OF DUTIES 1 University of Cincinnati Cincinnati, Ohio As a professor I am responsible for leading research into the safety of a variety of chemicals, improving methods for assessment and educating students, other scientists and the general public on risk issues. 2 Toxicology Excellence for Risk Assessment Cincinnati, Ohio As the Director and President, I was responsible for leading research into the safety of a variety of chemicals, improving methods for assessment and educating other scientists and the general public on risk issues. 3 North American Flame Retardant Washington DC, As a member of a diverse science advisory committee, I was responsible Association District of for advising NAFRA on risk issues associated with flame retardant Columbia chemicals and publishing relevant research. 5. Spouse's Employment Assets & Income and Retirement Accounts # DESCRIPTION EIF VALUE INCOME TYPE INCOME AMOUNT 1 Martha C. Dourson, LLC (solo law practice in N/A $15,001 - Legal fees probate and estates) $50,000 6. Other Assets and Income # DESCRIPTION EIF VALUE INCOME TYPE INCOME AMOUNT 1 Red River Gorgeous, LLC, residential real N/A $50,001 - Rent or $1,001 - $2,500 estate (Stanton, Kentucky) $100,000 Royalties 2 Tomlinson, Dourson and Culler, a General N/A $50,001 - Rent or $201 $1,000 Partnership owning farmland (Lucas, Ohio) $100,000 Royalties 3 U.S. federal credit union (cash accounts) N/A $50,001 - None (or less $100,000 than $201) 4 U.S. financial institution (cash accounts) N/A $1,001 - $15,000 None (or less than $201) Source: https://www.industrydocuments.ucsf.edu/docs/jsbn0226

What is the value listed for Tomlinson, Dourson and Culler?

jsbn0226

jsbn0226_p2, jsbn0226_p3

$50,001 - $100,000, $50,001-$100,000

# DESCRIPTION EIF VALUE INCOME TYPE INCOME AMOUNT 7 TIAA-CREF Bond Market R1 Yes $15,001 - None (or less $50,000 than $201) 8 TIAA Access Bond Plus Fund T4 Yes $15,001 - None (or less $50,000 than $201) 9 TIAA-CREF Inflation-Linked Bond R1 Yes $15,001 - None (or less $50,000 than $201) 10 TIAA-CREF Lifecycle 2015 Fund - Premier Yes $1,001 - $15,000 None (or less Class than $201) 11 North American Flame Retardant N/A Consulting fees $10,000 Association (protection of lives and property from fire) 12 Mercatus Center, George Mason University - N/A Hononarium $500 June 28, 2016 13 "Messiah's Star (Evidence for Faith) (Volume N/A None (or less 1)," CreateSpace Independent Publishing than $201) Platform (value not readily ascertainable) 14 "The Beginning: Let there be light (Evidence N/A None (or less of Faith) (Volume 2),' CreateSpace than $201) Independent Publishing Platform (value not readily ascertainable) 15 "The Linen Cloths: Jesus left behind N/A None (or less (Evidence of Faith) (Volume 3), CreateSpace than $201) Independent Publishing Platform (value not readily ascertainable) 3. Filer's Employment Agreements and Arrangements # EMPLOYER OR PARTY CITY, STATE STATUS AND TERMS DATE 1 University of Cincinnati, State Teachers' Cincinnati, Ohio I will continue to participate in this defined 8/2015 Retirement System (OHIO) contribution plan. The plan sponsor will not make further contributions after my separation. 2 University of Cincinnati, TIAA-CREF Cincinnati, Ohio I will continue to participate in this defined 8/2015 contribution plan. The plan sponsor will not make further contributions after my separation. Source: https://www.industrydocuments.ucsf.edu/docs/jsbn0226 4. Filer's Sources of Compensation Exceeding $5,000 in a Year # SOURCE NAME CITY, STATE BRIEF DESCRIPTION OF DUTIES 1 University of Cincinnati Cincinnati, Ohio As a professor I am responsible for leading research into the safety of a variety of chemicals, improving methods for assessment and educating students, other scientists and the general public on risk issues. 2 Toxicology Excellence for Risk Assessment Cincinnati, Ohio As the Director and President, I was responsible for leading research into the safety of a variety of chemicals, improving methods for assessment and educating other scientists and the general public on risk issues. 3 North American Flame Retardant Washington DC, As a member of a diverse science advisory committee, I was responsible Association District of for advising NAFRA on risk issues associated with flame retardant Columbia chemicals and publishing relevant research. 5. Spouse's Employment Assets & Income and Retirement Accounts # DESCRIPTION EIF VALUE INCOME TYPE INCOME AMOUNT 1 Martha C. Dourson, LLC (solo law practice in N/A $15,001 - Legal fees probate and estates) $50,000 6. Other Assets and Income # DESCRIPTION EIF VALUE INCOME TYPE INCOME AMOUNT 1 Red River Gorgeous, LLC, residential real N/A $50,001 - Rent or $1,001 - $2,500 estate (Stanton, Kentucky) $100,000 Royalties 2 Tomlinson, Dourson and Culler, a General N/A $50,001 - Rent or $201 $1,000 Partnership owning farmland (Lucas, Ohio) $100,000 Royalties 3 U.S. federal credit union (cash accounts) N/A $50,001 - None (or less $100,000 than $201) 4 U.S. financial institution (cash accounts) N/A $1,001 - $15,000 None (or less than $201) Source: https://www.industrydocuments.ucsf.edu/docs/jsbn0226

Who was responsible for educating other scientists on risk issues?

jsbn0226

jsbn0226_p2, jsbn0226_p3

PROFESSOR, Director and President.

# DESCRIPTION EIF VALUE INCOME TYPE INCOME AMOUNT 7 TIAA-CREF Bond Market R1 Yes $15,001 - None (or less $50,000 than $201) 8 TIAA Access Bond Plus Fund T4 Yes $15,001 - None (or less $50,000 than $201) 9 TIAA-CREF Inflation-Linked Bond R1 Yes $15,001 - None (or less $50,000 than $201) 10 TIAA-CREF Lifecycle 2015 Fund - Premier Yes $1,001 - $15,000 None (or less Class than $201) 11 North American Flame Retardant N/A Consulting fees $10,000 Association (protection of lives and property from fire) 12 Mercatus Center, George Mason University - N/A Hononarium $500 June 28, 2016 13 "Messiah's Star (Evidence for Faith) (Volume N/A None (or less 1)," CreateSpace Independent Publishing than $201) Platform (value not readily ascertainable) 14 "The Beginning: Let there be light (Evidence N/A None (or less of Faith) (Volume 2),' CreateSpace than $201) Independent Publishing Platform (value not readily ascertainable) 15 "The Linen Cloths: Jesus left behind N/A None (or less (Evidence of Faith) (Volume 3), CreateSpace than $201) Independent Publishing Platform (value not readily ascertainable) 3. Filer's Employment Agreements and Arrangements # EMPLOYER OR PARTY CITY, STATE STATUS AND TERMS DATE 1 University of Cincinnati, State Teachers' Cincinnati, Ohio I will continue to participate in this defined 8/2015 Retirement System (OHIO) contribution plan. The plan sponsor will not make further contributions after my separation. 2 University of Cincinnati, TIAA-CREF Cincinnati, Ohio I will continue to participate in this defined 8/2015 contribution plan. The plan sponsor will not make further contributions after my separation. Source: https://www.industrydocuments.ucsf.edu/docs/jsbn0226 4. Filer's Sources of Compensation Exceeding $5,000 in a Year # SOURCE NAME CITY, STATE BRIEF DESCRIPTION OF DUTIES 1 University of Cincinnati Cincinnati, Ohio As a professor I am responsible for leading research into the safety of a variety of chemicals, improving methods for assessment and educating students, other scientists and the general public on risk issues. 2 Toxicology Excellence for Risk Assessment Cincinnati, Ohio As the Director and President, I was responsible for leading research into the safety of a variety of chemicals, improving methods for assessment and educating other scientists and the general public on risk issues. 3 North American Flame Retardant Washington DC, As a member of a diverse science advisory committee, I was responsible Association District of for advising NAFRA on risk issues associated with flame retardant Columbia chemicals and publishing relevant research. 5. Spouse's Employment Assets & Income and Retirement Accounts # DESCRIPTION EIF VALUE INCOME TYPE INCOME AMOUNT 1 Martha C. Dourson, LLC (solo law practice in N/A $15,001 - Legal fees probate and estates) $50,000 6. Other Assets and Income # DESCRIPTION EIF VALUE INCOME TYPE INCOME AMOUNT 1 Red River Gorgeous, LLC, residential real N/A $50,001 - Rent or $1,001 - $2,500 estate (Stanton, Kentucky) $100,000 Royalties 2 Tomlinson, Dourson and Culler, a General N/A $50,001 - Rent or $201 $1,000 Partnership owning farmland (Lucas, Ohio) $100,000 Royalties 3 U.S. federal credit union (cash accounts) N/A $50,001 - None (or less $100,000 than $201) 4 U.S. financial institution (cash accounts) N/A $1,001 - $15,000 None (or less than $201) Source: https://www.industrydocuments.ucsf.edu/docs/jsbn0226

What does OIRA stand for?

hzbn0226

hzbn0226_p0, hzbn0226_p1, hzbn0226_p2, hzbn0226_p3, hzbn0226_p4, hzbn0226_p5

Office of Information and Regulatory Affairs., OFFICE OF INFORMATION AND REGULATORY AFFAIRS

NIPPING IRIS IN THE BUD: SUPPRESSION OF ENVIRONMENTAL SCIENCE BY THE BUSH ADMINISTRATION'S OFFICE OF MANAGEMENT AND BUDGET A staff report by the Majority Staff of the Subcommittee on Investigations and Oversight for Subcommittee Chairman Brad Miller Committee on Science and Technology U.S. House of Representatives June 11,2009 Source: https://www.industrydocuments.ucsf.edu/docs/hzbn0226 Table of Contents 1. Staff Report page 1 2. Attachments after page 16 A. e-mails and interagency review comments related to February 15, 2006 Office of Information and Regulatory Affairs (OIRA) response to Environmental Protection Agency (EPA) regarding a polybrominated diphenyl ethers (PBDE) draft assessment. B. e-mails and interagency review comments related to February 7, 2006 OIRA response to EPA regarding a dibutyl phthalate draft assessment. C. Comments from OMB of April 19, 2005 related to the EPA's February draft of a toluene assessment. D. e-mails and summary EPA responses to comments received from OIRA regarding a December 2003 draft of a toluene assessment. E. EPA e-mail from September 2004 regarding OIRA process questions. F. EPA e-mail from May 2005 regarding the ongoing IRIS process review. G. Department of Defense e-mail from February 2006 regarding interagency reaction to the proposed IRIS process. H. EPA's new Integrated Risk Information System process with timelines as announced on May 20, 2009. Source: https://www.industrydocuments.ucsf.edu/docs/hzbn0226 NIPPING IRIS IN THE BUD: SUPPRESSION OF ENVIRONMENTAL SCIENCE BY THE BUSH ADMINISTRATION'S OFFICE OF MANAGEMENT AND BUDGET By the end of the Bush Administration, the Environmental Protection Agency's (EPA) Integrated Risk Information System (IRIS) process was broken. What began two decades ago as an initiative at EPA to establish a reliable database on what science said about the risks of particular chemicals devolved by the end of the Bush Administration into a tortured round of interagency bickering, mediated and even stimulated by the Office of Information and Regulatory Affairs (OIRA). As a result of the IRIS process breaking down, public health offices across the country and around the world, as well as concerned citizens, were left without the reliable, expanding, up-to-date database of chemical risks that they had come to rely upon. The Bush Administration's OIRA used its position at the top of the Executive branch to force EPA to undergo a multi-year, interagency review ostensibly designed to establish a new process for creating new or updated IRIS database entries. At the same time, OIRA both supplied detailed scientific challenges to proposed IRIS entries and coordinated scientific comment from agencies across the government. OIRA's own scientific comments on proposed listings included detailed editorial comments that would have changed the import and meaning of the scientific findings in EPA's documents. All of this was done in secret, without any acknowledgement to the public or the Congress that OIRA was calling the shots.¹ IRIS was broken, not by accident, but through conscious, sustained effort from officials in OIRA. 1. The Subcommittee has carried out extensive work on OIRA's role in relationship to IRIS. In 2008, the Subcommittee held two hearings on this subject. The first of these hearings was on May 21, 2008, when the Subcommittee took testimony from Dr. George Gray, the then-Assistant Administrator for Research and Development at EPA, and Ms. Susan Dudley, the then-Administrator of the Office of Information and Regulatory Affairs (OIRA) at the Office of Management and Budget. Additionally, Mr. John Stephenson of GAO testified on findings regarding the lack of productivity in the IRIS process. In the second hearing, on June 12, 2008, the Subcommittee received testimony from Mr. Jerry Ensminger (U.S.M.C., retired) Mr. Lenny Seigel (Executive Director, Center for Public Environmental Oversight), and Dr. Linda Greer (Directer of the Health Program at the Natural Resources Defense Council). On June 11, 2008 Chairman Miller sent a document request to OMB asking for all materials relating to OIRA's involvement in the proposed IRIS entry for trichloroethylene (TCE). In response, the Committee received a few boxes of materials. The great majority of those materials were either peer reviewed articles, articles done by EPA staff, or research reports done under contract to industry or polluting agencies. Subcommittee staff were obliged to visit OMB's office to review thousands of pages of documents and take notes because the office refused to provide copies. A clear picture of OIRA's almost daily involvement on TCE emerged from that review. However, OIRA refused to provide access to most documents regarding interagency communications or internal communications surrounding TCE. Because the 110th Congress was drawing to a close, it was not practical to push for a subpoena for these records. We were never shown any document that could have been construed as having Executive Privilege attached to it. OIRA's entire approach appeared to amount to little more than obstruction of the work of the Subcommittee; in a sense, OIRA did to the Subcommittee's investigation what they have perfected in terms of slow-rolling IRIS proposals. 1 Source: https://wwww.industrydocuments.ucsf.edu/docs/hzbn0226 BACKGROUND OIRA is a small office of some 50 career staff housed inside the Office of Management and Budget (OMB). With origins in the Paperwork Reduction Act of 1980, OIRA's role has expanded well beyond simply trying to reduce the paperwork burden on citizens and businesses to being the central White House voice, some would say choke-point, on regulations of all varieties. It has been OIRA that has most passionately and persistently insisted on using cost-benefit analysis in assessing proposed regulations, even in the face of criticism that such calculations tend to understate benefits because many of them are so hard to monetize, like the value of a human life. 2 Historically, it has been staffed by statisticians, economists and lawyers. There are real differences between the way OIRA operated under President Bill Clinton and under President George W. Bush, but there is a consistent theme of OIRA being a watchdog on what regulatory agencies were attempting to do to comply with statutes and, on occasion, court orders. In the 110th Congress, at the direction of Subcommittee Chairman Brad Miller (D-NC), the Subcommittee on Investigations and Oversight looked very carefully at how OIRA was interfering with the science-based work of regulatory agencies. In addition to two hearings on Executive Order 13422, which the Bush Administration put in place to empower OIRA to control regulatory agendas at agencies across the government-an order the Obama Administration has now withdrawn--the Subcommittee held two hearings on the IRIS at EPA. IRIS provided a perfect example of how OIRA was branching out into challenging the science being done at regulatory agencies. A chemical's entry in the IRIS database is nothing more than a science-based assessment of risks associated with a particular chemical. IRIS entries are produced in the Office of Research and Development (ORD) of EPA, and those entries are not an expression of regulatory intent or advice. The entries are not even all that is required of a complete risk assessment as defined in the seminal National Academies of Science report, Risk Assessment in the Federal Government: Managing the Process (1983). 3 And risk assessment is a long step away from a regulatory effort, which is described in the terminology of the panel as "risk management." However, the absence of IRIS entries for widely used, toxic chemicals leaves state and local regulators, first responders, and citizens without crucial information that can guide their response to an emergency or an emerging health or environmental threat. OIRA has been involved in the IRIS process since the closing years of the Clinton 2. "Life's Value Shrinks at EPA," Matthew Madia, OMB Watch, July 22, 2008. 3. In that 1983 report, "Risk Assessment in the Federal Government: Managing the Process," the National Research Council panel identified four components of a complete risk assessment: hazard identification, dose-response evaluation, exposure assessment, and risk characterization. IRIS reflects science that addresses the first two conditions. In discussing the difference between risk assessment and risk management, the Academy panel wrote: "Risk assessment is the use of the factual base to define the health effects of exposure of individuals or populations to hazardous materials and situations. Risk management is the process of weighing policy alternatives and selecting the most appropriate regulatory action, integrating the results of risk assessment with engineering data and with social, economic and political concerns to reach a decision." See the discussion on page 3 of the 1983 report. 2 Source: https://www.industrydocuments.ucsf.edu/docs/hzbn0226 Administration. Initially OIRA was pulled into the process to facilitate interagency discussions about particular chemicals proposed for IRIS listings. Agencies that had a record of pollution with certain chemicals were concerned that new IRIS standards would trigger the long march to new regulations and the end result would be that the polluting agencies would have to change their practices and clean up legacy wastes. Those who polluted saw that disputing what scientific research had found about the risks of a particular chemical could become the first line of defense against the distant possibility of regulation.4 By the late 1990s, OIRA was playing a role as facilitator for interagency discussions regarding particularly contentious proposed IRIS listings. 5 Suppressing IRIS entries essentially shuts down the flow of coherent, reliable information about what chemicals pose what kinds of risks. Testimony received by the Subcommittee at the second day of hearings on this subject emphasized the important role of IRIS as a public health and safety resource. That hearing, entitled, "Toxic Communities: How EPA's IRIS Program Fails the Public," took testimony from U.S.M.C. (retired) Master Sergeant Jerry Ensminger, the Executive Director of the Center for Public Environmental Oversight, Mr. Lenny Siegel, and Dr. Linda E. Greer, Director for Health Programs at the Natural Resources Defense Council. Mr. Ensminger was particularly compelling in making a case for why polluting agencies such as DOD should not be allowed privileged access to discussions about the science of potential pollutants. It is a known fact that the United States Department of Defense is our nation's largest polluter. It is beyond my comprehension why an entity with that type of reputation and who has a vested interest in seeing little to no environmental oversight would be included in the scientific process. Not only are they obstructing science, they are also jeopardizing the public health for millions of people all around the world and yet this Administration and past Congresses have allowed DOD's tentacles to infiltrate the realm of science. 6 Mr. Ensminger was stationed at Camp LeJeune. His daughter, Janey, died of acute 4. This effort by polluters, or those who fear regulation of whatever stripe, of pushing the struggle back to what the science says about a particular risk rather than arguing over how to structure a regulation has been described as "paralysis by analysis." Science lends itself to endless study because there is never an absolute, final answer to any question, but always another layer of research that could add to the body of accumulated knowledge. If those who want to avoid regulation can shift the terms of discussion from the risk management end of the spectrum to the science and what uncertainties remain, a regulatory struggle need never begin. For analysis of how this process has unfolded among regulated industries, see, David Michaels, Doubt Is Their Product: How Industry's Assault on Science Threatens Your Health, Oxford University Press, New York, 2008. 5. A new report from the Center for Progressive Reform has some of this history. The Subcommittee was also able to review records from 1998 when OIRA first began to push into the interagency struggles over characterizing risks to former marines and their families from TCE and other chemicals at Camp LeJeune. At that time, OIRA's interest was more in the costs of the studies and making sure the then-proposed survey study met OIRA quality standards. OIRA reviews all survey instruments as part of its authority under the Paperwork Reduction Act of 1980. 6. "Toxic Communities: How EPA's IRIS Program Fails the Public," Hearing before the Subcommittee on Investigations and Oversight, Committee on Science and Technology, June 12, 2008, p. 132. 3 Source: https://www.industrydocuments.ucsf.edu/docs/hzbn0226 lymposytic leukemia. Water at the Camp was contaminated with trichloroethylene (TCE) and perchlorate (perc) and these chemicals, as well as other volatile organic compounds in the water system at the Camp, may have caused Janey's condition. DOD has been working for many years to block new IRIS standards on TCE and perc. In the Bush Administration, OIRA's involvement changed in scope and kind. John Graham, the first director of OIRA, brought in technical specialists-including toxicologists-to tend to science-based discussions of proposed environmental regulations, guidance and IRIS entries. Graham also oversaw a complete overhaul- some might describe it as an endless evolution-of the review and approval process for IRIS proposals. This report will describe that tumultuous review process, how it impacted EPA's productivity and independence, and the true nature of OIRA's role in the interagency review process. OIRA DOES SCIENCE Before turning to how the IRIS process was subjected to ongoing interagency negotiations, it is worth examining the day-to-day reality of working on IRIS entries. OIRA has always claimed to Congress and the public that its sole function was as a facilitator of interagency science discussions. John Graham's successor at OIRA, Susan Dudley, described OIRA's role in language that might have applied during the late- Clinton years. An exchange Ms. Dudley had with Subcommittee Chairman Miller in testimony before the Subcommittee on May 21, 2008 is worth quoting at length: Chairman Miller. Ms. Dudley, do you think it is part of the role of OMB to review scientific assessments prepared by other agencies of government? Ms. Dudley. OMB serves a coordinating function. We coordinate interagency review of various things, so OMB's role I think is a legitimate role. We have scientists that engage other scientists throughout the Federal Government in reviewing IRIS assessments. Chairman Miller. Well, I understand that there is one toxicologist that works for OIRA, is that correct? Ms. Dudley. You know, I am not sure exactly their credentials. We have toxicologists, risk assessors, statisticians. Chairman Miller. Well, they are remarkably productive, because they respond point by point in great detail at great length to the assessments that come up from the scientific agencies of government. Is that all done in-house or are there others who are invited to participate in OIRA's work or OMB's work? 7. Rebecca Clarren, "The EPA's Stalin Era," Salon.com, November 11, 2008. This article has a succinct discussion of how IRIS entries, or the lack of them, impacts communities facing pollution problems. 4 Source: https://www.industrydocuments.ucsf.edu/docs/hzbn0226

What does EPA stand for?

hzbn0226

hzbn0226_p0, hzbn0226_p1, hzbn0226_p2, hzbn0226_p3, hzbn0226_p4, hzbn0226_p5

Environmental Protection Agency., ENVIRONMENTAL PROTECTION AGENCY

NIPPING IRIS IN THE BUD: SUPPRESSION OF ENVIRONMENTAL SCIENCE BY THE BUSH ADMINISTRATION'S OFFICE OF MANAGEMENT AND BUDGET A staff report by the Majority Staff of the Subcommittee on Investigations and Oversight for Subcommittee Chairman Brad Miller Committee on Science and Technology U.S. House of Representatives June 11,2009 Source: https://www.industrydocuments.ucsf.edu/docs/hzbn0226 Table of Contents 1. Staff Report page 1 2. Attachments after page 16 A. e-mails and interagency review comments related to February 15, 2006 Office of Information and Regulatory Affairs (OIRA) response to Environmental Protection Agency (EPA) regarding a polybrominated diphenyl ethers (PBDE) draft assessment. B. e-mails and interagency review comments related to February 7, 2006 OIRA response to EPA regarding a dibutyl phthalate draft assessment. C. Comments from OMB of April 19, 2005 related to the EPA's February draft of a toluene assessment. D. e-mails and summary EPA responses to comments received from OIRA regarding a December 2003 draft of a toluene assessment. E. EPA e-mail from September 2004 regarding OIRA process questions. F. EPA e-mail from May 2005 regarding the ongoing IRIS process review. G. Department of Defense e-mail from February 2006 regarding interagency reaction to the proposed IRIS process. H. EPA's new Integrated Risk Information System process with timelines as announced on May 20, 2009. Source: https://www.industrydocuments.ucsf.edu/docs/hzbn0226 NIPPING IRIS IN THE BUD: SUPPRESSION OF ENVIRONMENTAL SCIENCE BY THE BUSH ADMINISTRATION'S OFFICE OF MANAGEMENT AND BUDGET By the end of the Bush Administration, the Environmental Protection Agency's (EPA) Integrated Risk Information System (IRIS) process was broken. What began two decades ago as an initiative at EPA to establish a reliable database on what science said about the risks of particular chemicals devolved by the end of the Bush Administration into a tortured round of interagency bickering, mediated and even stimulated by the Office of Information and Regulatory Affairs (OIRA). As a result of the IRIS process breaking down, public health offices across the country and around the world, as well as concerned citizens, were left without the reliable, expanding, up-to-date database of chemical risks that they had come to rely upon. The Bush Administration's OIRA used its position at the top of the Executive branch to force EPA to undergo a multi-year, interagency review ostensibly designed to establish a new process for creating new or updated IRIS database entries. At the same time, OIRA both supplied detailed scientific challenges to proposed IRIS entries and coordinated scientific comment from agencies across the government. OIRA's own scientific comments on proposed listings included detailed editorial comments that would have changed the import and meaning of the scientific findings in EPA's documents. All of this was done in secret, without any acknowledgement to the public or the Congress that OIRA was calling the shots.¹ IRIS was broken, not by accident, but through conscious, sustained effort from officials in OIRA. 1. The Subcommittee has carried out extensive work on OIRA's role in relationship to IRIS. In 2008, the Subcommittee held two hearings on this subject. The first of these hearings was on May 21, 2008, when the Subcommittee took testimony from Dr. George Gray, the then-Assistant Administrator for Research and Development at EPA, and Ms. Susan Dudley, the then-Administrator of the Office of Information and Regulatory Affairs (OIRA) at the Office of Management and Budget. Additionally, Mr. John Stephenson of GAO testified on findings regarding the lack of productivity in the IRIS process. In the second hearing, on June 12, 2008, the Subcommittee received testimony from Mr. Jerry Ensminger (U.S.M.C., retired) Mr. Lenny Seigel (Executive Director, Center for Public Environmental Oversight), and Dr. Linda Greer (Directer of the Health Program at the Natural Resources Defense Council). On June 11, 2008 Chairman Miller sent a document request to OMB asking for all materials relating to OIRA's involvement in the proposed IRIS entry for trichloroethylene (TCE). In response, the Committee received a few boxes of materials. The great majority of those materials were either peer reviewed articles, articles done by EPA staff, or research reports done under contract to industry or polluting agencies. Subcommittee staff were obliged to visit OMB's office to review thousands of pages of documents and take notes because the office refused to provide copies. A clear picture of OIRA's almost daily involvement on TCE emerged from that review. However, OIRA refused to provide access to most documents regarding interagency communications or internal communications surrounding TCE. Because the 110th Congress was drawing to a close, it was not practical to push for a subpoena for these records. We were never shown any document that could have been construed as having Executive Privilege attached to it. OIRA's entire approach appeared to amount to little more than obstruction of the work of the Subcommittee; in a sense, OIRA did to the Subcommittee's investigation what they have perfected in terms of slow-rolling IRIS proposals. 1 Source: https://wwww.industrydocuments.ucsf.edu/docs/hzbn0226 BACKGROUND OIRA is a small office of some 50 career staff housed inside the Office of Management and Budget (OMB). With origins in the Paperwork Reduction Act of 1980, OIRA's role has expanded well beyond simply trying to reduce the paperwork burden on citizens and businesses to being the central White House voice, some would say choke-point, on regulations of all varieties. It has been OIRA that has most passionately and persistently insisted on using cost-benefit analysis in assessing proposed regulations, even in the face of criticism that such calculations tend to understate benefits because many of them are so hard to monetize, like the value of a human life. 2 Historically, it has been staffed by statisticians, economists and lawyers. There are real differences between the way OIRA operated under President Bill Clinton and under President George W. Bush, but there is a consistent theme of OIRA being a watchdog on what regulatory agencies were attempting to do to comply with statutes and, on occasion, court orders. In the 110th Congress, at the direction of Subcommittee Chairman Brad Miller (D-NC), the Subcommittee on Investigations and Oversight looked very carefully at how OIRA was interfering with the science-based work of regulatory agencies. In addition to two hearings on Executive Order 13422, which the Bush Administration put in place to empower OIRA to control regulatory agendas at agencies across the government-an order the Obama Administration has now withdrawn--the Subcommittee held two hearings on the IRIS at EPA. IRIS provided a perfect example of how OIRA was branching out into challenging the science being done at regulatory agencies. A chemical's entry in the IRIS database is nothing more than a science-based assessment of risks associated with a particular chemical. IRIS entries are produced in the Office of Research and Development (ORD) of EPA, and those entries are not an expression of regulatory intent or advice. The entries are not even all that is required of a complete risk assessment as defined in the seminal National Academies of Science report, Risk Assessment in the Federal Government: Managing the Process (1983). 3 And risk assessment is a long step away from a regulatory effort, which is described in the terminology of the panel as "risk management." However, the absence of IRIS entries for widely used, toxic chemicals leaves state and local regulators, first responders, and citizens without crucial information that can guide their response to an emergency or an emerging health or environmental threat. OIRA has been involved in the IRIS process since the closing years of the Clinton 2. "Life's Value Shrinks at EPA," Matthew Madia, OMB Watch, July 22, 2008. 3. In that 1983 report, "Risk Assessment in the Federal Government: Managing the Process," the National Research Council panel identified four components of a complete risk assessment: hazard identification, dose-response evaluation, exposure assessment, and risk characterization. IRIS reflects science that addresses the first two conditions. In discussing the difference between risk assessment and risk management, the Academy panel wrote: "Risk assessment is the use of the factual base to define the health effects of exposure of individuals or populations to hazardous materials and situations. Risk management is the process of weighing policy alternatives and selecting the most appropriate regulatory action, integrating the results of risk assessment with engineering data and with social, economic and political concerns to reach a decision." See the discussion on page 3 of the 1983 report. 2 Source: https://www.industrydocuments.ucsf.edu/docs/hzbn0226 Administration. Initially OIRA was pulled into the process to facilitate interagency discussions about particular chemicals proposed for IRIS listings. Agencies that had a record of pollution with certain chemicals were concerned that new IRIS standards would trigger the long march to new regulations and the end result would be that the polluting agencies would have to change their practices and clean up legacy wastes. Those who polluted saw that disputing what scientific research had found about the risks of a particular chemical could become the first line of defense against the distant possibility of regulation.4 By the late 1990s, OIRA was playing a role as facilitator for interagency discussions regarding particularly contentious proposed IRIS listings. 5 Suppressing IRIS entries essentially shuts down the flow of coherent, reliable information about what chemicals pose what kinds of risks. Testimony received by the Subcommittee at the second day of hearings on this subject emphasized the important role of IRIS as a public health and safety resource. That hearing, entitled, "Toxic Communities: How EPA's IRIS Program Fails the Public," took testimony from U.S.M.C. (retired) Master Sergeant Jerry Ensminger, the Executive Director of the Center for Public Environmental Oversight, Mr. Lenny Siegel, and Dr. Linda E. Greer, Director for Health Programs at the Natural Resources Defense Council. Mr. Ensminger was particularly compelling in making a case for why polluting agencies such as DOD should not be allowed privileged access to discussions about the science of potential pollutants. It is a known fact that the United States Department of Defense is our nation's largest polluter. It is beyond my comprehension why an entity with that type of reputation and who has a vested interest in seeing little to no environmental oversight would be included in the scientific process. Not only are they obstructing science, they are also jeopardizing the public health for millions of people all around the world and yet this Administration and past Congresses have allowed DOD's tentacles to infiltrate the realm of science. 6 Mr. Ensminger was stationed at Camp LeJeune. His daughter, Janey, died of acute 4. This effort by polluters, or those who fear regulation of whatever stripe, of pushing the struggle back to what the science says about a particular risk rather than arguing over how to structure a regulation has been described as "paralysis by analysis." Science lends itself to endless study because there is never an absolute, final answer to any question, but always another layer of research that could add to the body of accumulated knowledge. If those who want to avoid regulation can shift the terms of discussion from the risk management end of the spectrum to the science and what uncertainties remain, a regulatory struggle need never begin. For analysis of how this process has unfolded among regulated industries, see, David Michaels, Doubt Is Their Product: How Industry's Assault on Science Threatens Your Health, Oxford University Press, New York, 2008. 5. A new report from the Center for Progressive Reform has some of this history. The Subcommittee was also able to review records from 1998 when OIRA first began to push into the interagency struggles over characterizing risks to former marines and their families from TCE and other chemicals at Camp LeJeune. At that time, OIRA's interest was more in the costs of the studies and making sure the then-proposed survey study met OIRA quality standards. OIRA reviews all survey instruments as part of its authority under the Paperwork Reduction Act of 1980. 6. "Toxic Communities: How EPA's IRIS Program Fails the Public," Hearing before the Subcommittee on Investigations and Oversight, Committee on Science and Technology, June 12, 2008, p. 132. 3 Source: https://www.industrydocuments.ucsf.edu/docs/hzbn0226 lymposytic leukemia. Water at the Camp was contaminated with trichloroethylene (TCE) and perchlorate (perc) and these chemicals, as well as other volatile organic compounds in the water system at the Camp, may have caused Janey's condition. DOD has been working for many years to block new IRIS standards on TCE and perc. In the Bush Administration, OIRA's involvement changed in scope and kind. John Graham, the first director of OIRA, brought in technical specialists-including toxicologists-to tend to science-based discussions of proposed environmental regulations, guidance and IRIS entries. Graham also oversaw a complete overhaul- some might describe it as an endless evolution-of the review and approval process for IRIS proposals. This report will describe that tumultuous review process, how it impacted EPA's productivity and independence, and the true nature of OIRA's role in the interagency review process. OIRA DOES SCIENCE Before turning to how the IRIS process was subjected to ongoing interagency negotiations, it is worth examining the day-to-day reality of working on IRIS entries. OIRA has always claimed to Congress and the public that its sole function was as a facilitator of interagency science discussions. John Graham's successor at OIRA, Susan Dudley, described OIRA's role in language that might have applied during the late- Clinton years. An exchange Ms. Dudley had with Subcommittee Chairman Miller in testimony before the Subcommittee on May 21, 2008 is worth quoting at length: Chairman Miller. Ms. Dudley, do you think it is part of the role of OMB to review scientific assessments prepared by other agencies of government? Ms. Dudley. OMB serves a coordinating function. We coordinate interagency review of various things, so OMB's role I think is a legitimate role. We have scientists that engage other scientists throughout the Federal Government in reviewing IRIS assessments. Chairman Miller. Well, I understand that there is one toxicologist that works for OIRA, is that correct? Ms. Dudley. You know, I am not sure exactly their credentials. We have toxicologists, risk assessors, statisticians. Chairman Miller. Well, they are remarkably productive, because they respond point by point in great detail at great length to the assessments that come up from the scientific agencies of government. Is that all done in-house or are there others who are invited to participate in OIRA's work or OMB's work? 7. Rebecca Clarren, "The EPA's Stalin Era," Salon.com, November 11, 2008. This article has a succinct discussion of how IRIS entries, or the lack of them, impacts communities facing pollution problems. 4 Source: https://www.industrydocuments.ucsf.edu/docs/hzbn0226

What does PBDE stand for?

hzbn0226

hzbn0226_p0, hzbn0226_p1, hzbn0226_p2, hzbn0226_p3, hzbn0226_p4, hzbn0226_p5

Polybrominated Diphenyl Ethers., POLYBROMINATED DIPHENYL ETHERS

NIPPING IRIS IN THE BUD: SUPPRESSION OF ENVIRONMENTAL SCIENCE BY THE BUSH ADMINISTRATION'S OFFICE OF MANAGEMENT AND BUDGET A staff report by the Majority Staff of the Subcommittee on Investigations and Oversight for Subcommittee Chairman Brad Miller Committee on Science and Technology U.S. House of Representatives June 11,2009 Source: https://www.industrydocuments.ucsf.edu/docs/hzbn0226 Table of Contents 1. Staff Report page 1 2. Attachments after page 16 A. e-mails and interagency review comments related to February 15, 2006 Office of Information and Regulatory Affairs (OIRA) response to Environmental Protection Agency (EPA) regarding a polybrominated diphenyl ethers (PBDE) draft assessment. B. e-mails and interagency review comments related to February 7, 2006 OIRA response to EPA regarding a dibutyl phthalate draft assessment. C. Comments from OMB of April 19, 2005 related to the EPA's February draft of a toluene assessment. D. e-mails and summary EPA responses to comments received from OIRA regarding a December 2003 draft of a toluene assessment. E. EPA e-mail from September 2004 regarding OIRA process questions. F. EPA e-mail from May 2005 regarding the ongoing IRIS process review. G. Department of Defense e-mail from February 2006 regarding interagency reaction to the proposed IRIS process. H. EPA's new Integrated Risk Information System process with timelines as announced on May 20, 2009. Source: https://www.industrydocuments.ucsf.edu/docs/hzbn0226 NIPPING IRIS IN THE BUD: SUPPRESSION OF ENVIRONMENTAL SCIENCE BY THE BUSH ADMINISTRATION'S OFFICE OF MANAGEMENT AND BUDGET By the end of the Bush Administration, the Environmental Protection Agency's (EPA) Integrated Risk Information System (IRIS) process was broken. What began two decades ago as an initiative at EPA to establish a reliable database on what science said about the risks of particular chemicals devolved by the end of the Bush Administration into a tortured round of interagency bickering, mediated and even stimulated by the Office of Information and Regulatory Affairs (OIRA). As a result of the IRIS process breaking down, public health offices across the country and around the world, as well as concerned citizens, were left without the reliable, expanding, up-to-date database of chemical risks that they had come to rely upon. The Bush Administration's OIRA used its position at the top of the Executive branch to force EPA to undergo a multi-year, interagency review ostensibly designed to establish a new process for creating new or updated IRIS database entries. At the same time, OIRA both supplied detailed scientific challenges to proposed IRIS entries and coordinated scientific comment from agencies across the government. OIRA's own scientific comments on proposed listings included detailed editorial comments that would have changed the import and meaning of the scientific findings in EPA's documents. All of this was done in secret, without any acknowledgement to the public or the Congress that OIRA was calling the shots.¹ IRIS was broken, not by accident, but through conscious, sustained effort from officials in OIRA. 1. The Subcommittee has carried out extensive work on OIRA's role in relationship to IRIS. In 2008, the Subcommittee held two hearings on this subject. The first of these hearings was on May 21, 2008, when the Subcommittee took testimony from Dr. George Gray, the then-Assistant Administrator for Research and Development at EPA, and Ms. Susan Dudley, the then-Administrator of the Office of Information and Regulatory Affairs (OIRA) at the Office of Management and Budget. Additionally, Mr. John Stephenson of GAO testified on findings regarding the lack of productivity in the IRIS process. In the second hearing, on June 12, 2008, the Subcommittee received testimony from Mr. Jerry Ensminger (U.S.M.C., retired) Mr. Lenny Seigel (Executive Director, Center for Public Environmental Oversight), and Dr. Linda Greer (Directer of the Health Program at the Natural Resources Defense Council). On June 11, 2008 Chairman Miller sent a document request to OMB asking for all materials relating to OIRA's involvement in the proposed IRIS entry for trichloroethylene (TCE). In response, the Committee received a few boxes of materials. The great majority of those materials were either peer reviewed articles, articles done by EPA staff, or research reports done under contract to industry or polluting agencies. Subcommittee staff were obliged to visit OMB's office to review thousands of pages of documents and take notes because the office refused to provide copies. A clear picture of OIRA's almost daily involvement on TCE emerged from that review. However, OIRA refused to provide access to most documents regarding interagency communications or internal communications surrounding TCE. Because the 110th Congress was drawing to a close, it was not practical to push for a subpoena for these records. We were never shown any document that could have been construed as having Executive Privilege attached to it. OIRA's entire approach appeared to amount to little more than obstruction of the work of the Subcommittee; in a sense, OIRA did to the Subcommittee's investigation what they have perfected in terms of slow-rolling IRIS proposals. 1 Source: https://wwww.industrydocuments.ucsf.edu/docs/hzbn0226 BACKGROUND OIRA is a small office of some 50 career staff housed inside the Office of Management and Budget (OMB). With origins in the Paperwork Reduction Act of 1980, OIRA's role has expanded well beyond simply trying to reduce the paperwork burden on citizens and businesses to being the central White House voice, some would say choke-point, on regulations of all varieties. It has been OIRA that has most passionately and persistently insisted on using cost-benefit analysis in assessing proposed regulations, even in the face of criticism that such calculations tend to understate benefits because many of them are so hard to monetize, like the value of a human life. 2 Historically, it has been staffed by statisticians, economists and lawyers. There are real differences between the way OIRA operated under President Bill Clinton and under President George W. Bush, but there is a consistent theme of OIRA being a watchdog on what regulatory agencies were attempting to do to comply with statutes and, on occasion, court orders. In the 110th Congress, at the direction of Subcommittee Chairman Brad Miller (D-NC), the Subcommittee on Investigations and Oversight looked very carefully at how OIRA was interfering with the science-based work of regulatory agencies. In addition to two hearings on Executive Order 13422, which the Bush Administration put in place to empower OIRA to control regulatory agendas at agencies across the government-an order the Obama Administration has now withdrawn--the Subcommittee held two hearings on the IRIS at EPA. IRIS provided a perfect example of how OIRA was branching out into challenging the science being done at regulatory agencies. A chemical's entry in the IRIS database is nothing more than a science-based assessment of risks associated with a particular chemical. IRIS entries are produced in the Office of Research and Development (ORD) of EPA, and those entries are not an expression of regulatory intent or advice. The entries are not even all that is required of a complete risk assessment as defined in the seminal National Academies of Science report, Risk Assessment in the Federal Government: Managing the Process (1983). 3 And risk assessment is a long step away from a regulatory effort, which is described in the terminology of the panel as "risk management." However, the absence of IRIS entries for widely used, toxic chemicals leaves state and local regulators, first responders, and citizens without crucial information that can guide their response to an emergency or an emerging health or environmental threat. OIRA has been involved in the IRIS process since the closing years of the Clinton 2. "Life's Value Shrinks at EPA," Matthew Madia, OMB Watch, July 22, 2008. 3. In that 1983 report, "Risk Assessment in the Federal Government: Managing the Process," the National Research Council panel identified four components of a complete risk assessment: hazard identification, dose-response evaluation, exposure assessment, and risk characterization. IRIS reflects science that addresses the first two conditions. In discussing the difference between risk assessment and risk management, the Academy panel wrote: "Risk assessment is the use of the factual base to define the health effects of exposure of individuals or populations to hazardous materials and situations. Risk management is the process of weighing policy alternatives and selecting the most appropriate regulatory action, integrating the results of risk assessment with engineering data and with social, economic and political concerns to reach a decision." See the discussion on page 3 of the 1983 report. 2 Source: https://www.industrydocuments.ucsf.edu/docs/hzbn0226 Administration. Initially OIRA was pulled into the process to facilitate interagency discussions about particular chemicals proposed for IRIS listings. Agencies that had a record of pollution with certain chemicals were concerned that new IRIS standards would trigger the long march to new regulations and the end result would be that the polluting agencies would have to change their practices and clean up legacy wastes. Those who polluted saw that disputing what scientific research had found about the risks of a particular chemical could become the first line of defense against the distant possibility of regulation.4 By the late 1990s, OIRA was playing a role as facilitator for interagency discussions regarding particularly contentious proposed IRIS listings. 5 Suppressing IRIS entries essentially shuts down the flow of coherent, reliable information about what chemicals pose what kinds of risks. Testimony received by the Subcommittee at the second day of hearings on this subject emphasized the important role of IRIS as a public health and safety resource. That hearing, entitled, "Toxic Communities: How EPA's IRIS Program Fails the Public," took testimony from U.S.M.C. (retired) Master Sergeant Jerry Ensminger, the Executive Director of the Center for Public Environmental Oversight, Mr. Lenny Siegel, and Dr. Linda E. Greer, Director for Health Programs at the Natural Resources Defense Council. Mr. Ensminger was particularly compelling in making a case for why polluting agencies such as DOD should not be allowed privileged access to discussions about the science of potential pollutants. It is a known fact that the United States Department of Defense is our nation's largest polluter. It is beyond my comprehension why an entity with that type of reputation and who has a vested interest in seeing little to no environmental oversight would be included in the scientific process. Not only are they obstructing science, they are also jeopardizing the public health for millions of people all around the world and yet this Administration and past Congresses have allowed DOD's tentacles to infiltrate the realm of science. 6 Mr. Ensminger was stationed at Camp LeJeune. His daughter, Janey, died of acute 4. This effort by polluters, or those who fear regulation of whatever stripe, of pushing the struggle back to what the science says about a particular risk rather than arguing over how to structure a regulation has been described as "paralysis by analysis." Science lends itself to endless study because there is never an absolute, final answer to any question, but always another layer of research that could add to the body of accumulated knowledge. If those who want to avoid regulation can shift the terms of discussion from the risk management end of the spectrum to the science and what uncertainties remain, a regulatory struggle need never begin. For analysis of how this process has unfolded among regulated industries, see, David Michaels, Doubt Is Their Product: How Industry's Assault on Science Threatens Your Health, Oxford University Press, New York, 2008. 5. A new report from the Center for Progressive Reform has some of this history. The Subcommittee was also able to review records from 1998 when OIRA first began to push into the interagency struggles over characterizing risks to former marines and their families from TCE and other chemicals at Camp LeJeune. At that time, OIRA's interest was more in the costs of the studies and making sure the then-proposed survey study met OIRA quality standards. OIRA reviews all survey instruments as part of its authority under the Paperwork Reduction Act of 1980. 6. "Toxic Communities: How EPA's IRIS Program Fails the Public," Hearing before the Subcommittee on Investigations and Oversight, Committee on Science and Technology, June 12, 2008, p. 132. 3 Source: https://www.industrydocuments.ucsf.edu/docs/hzbn0226 lymposytic leukemia. Water at the Camp was contaminated with trichloroethylene (TCE) and perchlorate (perc) and these chemicals, as well as other volatile organic compounds in the water system at the Camp, may have caused Janey's condition. DOD has been working for many years to block new IRIS standards on TCE and perc. In the Bush Administration, OIRA's involvement changed in scope and kind. John Graham, the first director of OIRA, brought in technical specialists-including toxicologists-to tend to science-based discussions of proposed environmental regulations, guidance and IRIS entries. Graham also oversaw a complete overhaul- some might describe it as an endless evolution-of the review and approval process for IRIS proposals. This report will describe that tumultuous review process, how it impacted EPA's productivity and independence, and the true nature of OIRA's role in the interagency review process. OIRA DOES SCIENCE Before turning to how the IRIS process was subjected to ongoing interagency negotiations, it is worth examining the day-to-day reality of working on IRIS entries. OIRA has always claimed to Congress and the public that its sole function was as a facilitator of interagency science discussions. John Graham's successor at OIRA, Susan Dudley, described OIRA's role in language that might have applied during the late- Clinton years. An exchange Ms. Dudley had with Subcommittee Chairman Miller in testimony before the Subcommittee on May 21, 2008 is worth quoting at length: Chairman Miller. Ms. Dudley, do you think it is part of the role of OMB to review scientific assessments prepared by other agencies of government? Ms. Dudley. OMB serves a coordinating function. We coordinate interagency review of various things, so OMB's role I think is a legitimate role. We have scientists that engage other scientists throughout the Federal Government in reviewing IRIS assessments. Chairman Miller. Well, I understand that there is one toxicologist that works for OIRA, is that correct? Ms. Dudley. You know, I am not sure exactly their credentials. We have toxicologists, risk assessors, statisticians. Chairman Miller. Well, they are remarkably productive, because they respond point by point in great detail at great length to the assessments that come up from the scientific agencies of government. Is that all done in-house or are there others who are invited to participate in OIRA's work or OMB's work? 7. Rebecca Clarren, "The EPA's Stalin Era," Salon.com, November 11, 2008. This article has a succinct discussion of how IRIS entries, or the lack of them, impacts communities facing pollution problems. 4 Source: https://www.industrydocuments.ucsf.edu/docs/hzbn0226

Which part discloses agreements or arrangements that the filer had during the reporting period with an employer or former employer?

jsbn0226

jsbn0226_p6, jsbn0226_p7, jsbn0226_p8

Part 3., PART 3

Summary of Contents 1. Filer's Positions Held Outside United States Government Part 1 discloses positions that the filer held at any time during the reporting period (excluding positions with the United States Government). Positions are reportable even if the filer did not receive compensation. This section does not include the following: (1) positions with religious, social, fraternal, or political organizations; (2) positions solely of an honorary nature; (3) positions held as part of the filer's official duties with the United States Government; (4) mere membership in an organization; and (5) passive investment interests as a limited partner or non-managing member of a limited liability company. 2. Filer's Employment Assets & Income and Retirement Accounts Part 2 discloses the following: Sources of earned and other non-investment income of the filer totaling more than $200 during the reporting period (e.g., salary, fees, partnership share, honoraria, scholarships, and prizes) Assets related to the filer's business, employment, or other income-generating activities that (1) ended the reporting period with a value greater than $1,000 or (2) produced more than $200 in income during the reporting period (e.g., equity in business or partnership, stock options, retirement plans/accounts and their underlying holdings as appropriate, deferred compensation, and intellectual property, such as book deals and patents) This section does not include assets or income from United States Government employment or assets that were acquired separately from the filer's business, employment, or other income-generating activities (e.g., assets purchased through a brokerage account). Note: The type of income is not required if the amount of income is $0 - $200 or if the asset qualifies as an excepted investment fund (EIF). 3. Filer's Employment Agreements and Arrangements Part 3 discloses agreements or arrangements that the filer had during the reporting period with an employer or former employer (except the United States Government), such as the following: Future employment Leave of absence Continuing payments from an employer, including severance and payments not yet received for previous work (excluding ordinary salary from a current employer) Continuing participation in an employee welfare, retirement, or other benefit plan, such as pensions or a deferred compensation plan Retention or disposition of employer-awarded equity, sharing in profits or carried interests (e.g., vested and unvested stock options, restricted stock, future share of a company's profits, etc.) 4. Filer's Sources of Compensation Exceeding $5,000 in a Year Part 4 discloses sources (except the United States Government) that paid more than $5,000 in a calendar year for the filer's services during any year of the reporting period. Source: https://www.industrydocuments.ucsf.edu/docs/jsbn0226 The filer discloses payments both from employers and from any clients to whom the filer personally provided services. The filer discloses a source even if the source made its payment to the filer's employer and not to the filer. The filer does not disclose a client's payment to the filer's employer if the filer did not provide the services for which the client is paying. 5. Spouse's Employment Assets & Income and Retirement Accounts Part 5 discloses the following: Sources of earned income (excluding honoraria) for the filer's spouse totaling more than $1,000 during the reporting period (e.g., salary, consulting fees, and partnership share) Sources of honoraria for the filer's spouse greater than $200 during the reporting period Assets related to the filer's spouse's employment, business activities, other income-generating activities that (1) ended the reporting period with a value greater than $1,000 or (2) produced more than $200 in income during the reporting period (e.g., equity in business or partnership, stock options, retirement plans/accounts and their underlying holdings as appropriate, deferred compensation, and intellectual property, such as book deals and patents) This section does not include assets or income from United States Government employment or assets that were acquired separately from the filer's spouse's business, employment, or other income-generating activities (e.g., assets purchased through a brokerage account). Note: The type of income is not required if the amount of income is $0 - $200 or if the asset qualifies as an excepted investment fund (EIF). Amounts of income are not required for a spouse's earned income (excluding honoraria). 6. Other Assets and Income Part 6 discloses each asset, not already reported, that (1) ended the reporting period with a value greater than $1,000 or (2) produced more than $200 in investment income during the reporting period. For purposes of the value and income thresholds, the filer aggregates the filer's interests with those of the filer's spouse and dependent children. This section does not include the following types of assets: (1) a personal residence (unless it was rented out during the reporting period); (2) income or retirement benefits associated with United States Government employment (e.g., Thrift Savings Plan); and (3) cash accounts (e.g., checking, savings, money market accounts) at a single financial institution with a value of $5,000 or less (unless more than $200 of income was produced). Additional exceptions apply. Note: The type of income is not required if the amount of income is $0 - $200 or if the asset qualifies as an excepted investment fund (EIF). 7. Transactions Part 7 discloses purchases, sales, or exchanges of real property or securities in excess of $1,000 made on behalf of the filer, the filer's spouse or dependent child during reporting period. This section does not include transactions that concern the following: (1) a personal residence, unless rented out; (2) cash accounts (e.g., checking, savings, CDs, money market accounts) and money market mutual funds; (3) Treasury bills, bonds, and notes; and (4) holdings within a federal Thrift Savings Plan account. Additional exceptions apply. Source: https://www.industrydocuments.ucsf.edu/docs/jsbn0226 8. Liabilities Part 8 discloses liabilities over $10,000 that the filer, the filer's spouse or dependent child owed at any time during the reporting period. This section does not include the following types of liabilities: (1) mortgages on a personal residence, unless rented out (limitations apply for PAS filers); (2) loans secured by a personal motor vehicle, household furniture, or appliances, unless the loan exceeds the item's purchase price; and (3) revolving charge accounts, such as credit card balances, if the outstanding liability did not exceed $10,000 at the end of the reporting period. Additional exceptions apply. 9. Gifts and Travel Reimbursements This section discloses: Gifts totaling more than $375 that the filer, the filer's spouse, and dependent children received from any one source during the reporting period. Travel reimbursements totaling more than $375 that the filer, the filer's spouse, and dependent children received from any one source during the reporting period. For purposes of this section, the filer need not aggregate any gift or travel reimbursement with a value of $150 or less. Regardless of the value, this section does not include the following items: (1) anything received from relatives; (2) anything received from the United States Government or from the District of Columbia, state, or local governments; (3) bequests and other forms of inheritance; (4) gifts and travel reimbursements given to the filer's agency in connection with the filer's official travel; (5) gifts of hospitality (food, lodging, entertainment) at the donor's residence or personal premises; and (6) anything received by the filer's spouse or dependent children totally independent of their relationship to the filer. Additional exceptions apply. Source: https://www.industrydocuments.ucsf.edu/docs/jsbn0226

Which part discloses the positions that the filer held at any time during the reporting period?

jsbn0226

jsbn0226_p6, jsbn0226_p7, jsbn0226_p8

PART 1, Part 1.

Summary of Contents 1. Filer's Positions Held Outside United States Government Part 1 discloses positions that the filer held at any time during the reporting period (excluding positions with the United States Government). Positions are reportable even if the filer did not receive compensation. This section does not include the following: (1) positions with religious, social, fraternal, or political organizations; (2) positions solely of an honorary nature; (3) positions held as part of the filer's official duties with the United States Government; (4) mere membership in an organization; and (5) passive investment interests as a limited partner or non-managing member of a limited liability company. 2. Filer's Employment Assets & Income and Retirement Accounts Part 2 discloses the following: Sources of earned and other non-investment income of the filer totaling more than $200 during the reporting period (e.g., salary, fees, partnership share, honoraria, scholarships, and prizes) Assets related to the filer's business, employment, or other income-generating activities that (1) ended the reporting period with a value greater than $1,000 or (2) produced more than $200 in income during the reporting period (e.g., equity in business or partnership, stock options, retirement plans/accounts and their underlying holdings as appropriate, deferred compensation, and intellectual property, such as book deals and patents) This section does not include assets or income from United States Government employment or assets that were acquired separately from the filer's business, employment, or other income-generating activities (e.g., assets purchased through a brokerage account). Note: The type of income is not required if the amount of income is $0 - $200 or if the asset qualifies as an excepted investment fund (EIF). 3. Filer's Employment Agreements and Arrangements Part 3 discloses agreements or arrangements that the filer had during the reporting period with an employer or former employer (except the United States Government), such as the following: Future employment Leave of absence Continuing payments from an employer, including severance and payments not yet received for previous work (excluding ordinary salary from a current employer) Continuing participation in an employee welfare, retirement, or other benefit plan, such as pensions or a deferred compensation plan Retention or disposition of employer-awarded equity, sharing in profits or carried interests (e.g., vested and unvested stock options, restricted stock, future share of a company's profits, etc.) 4. Filer's Sources of Compensation Exceeding $5,000 in a Year Part 4 discloses sources (except the United States Government) that paid more than $5,000 in a calendar year for the filer's services during any year of the reporting period. Source: https://www.industrydocuments.ucsf.edu/docs/jsbn0226 The filer discloses payments both from employers and from any clients to whom the filer personally provided services. The filer discloses a source even if the source made its payment to the filer's employer and not to the filer. The filer does not disclose a client's payment to the filer's employer if the filer did not provide the services for which the client is paying. 5. Spouse's Employment Assets & Income and Retirement Accounts Part 5 discloses the following: Sources of earned income (excluding honoraria) for the filer's spouse totaling more than $1,000 during the reporting period (e.g., salary, consulting fees, and partnership share) Sources of honoraria for the filer's spouse greater than $200 during the reporting period Assets related to the filer's spouse's employment, business activities, other income-generating activities that (1) ended the reporting period with a value greater than $1,000 or (2) produced more than $200 in income during the reporting period (e.g., equity in business or partnership, stock options, retirement plans/accounts and their underlying holdings as appropriate, deferred compensation, and intellectual property, such as book deals and patents) This section does not include assets or income from United States Government employment or assets that were acquired separately from the filer's spouse's business, employment, or other income-generating activities (e.g., assets purchased through a brokerage account). Note: The type of income is not required if the amount of income is $0 - $200 or if the asset qualifies as an excepted investment fund (EIF). Amounts of income are not required for a spouse's earned income (excluding honoraria). 6. Other Assets and Income Part 6 discloses each asset, not already reported, that (1) ended the reporting period with a value greater than $1,000 or (2) produced more than $200 in investment income during the reporting period. For purposes of the value and income thresholds, the filer aggregates the filer's interests with those of the filer's spouse and dependent children. This section does not include the following types of assets: (1) a personal residence (unless it was rented out during the reporting period); (2) income or retirement benefits associated with United States Government employment (e.g., Thrift Savings Plan); and (3) cash accounts (e.g., checking, savings, money market accounts) at a single financial institution with a value of $5,000 or less (unless more than $200 of income was produced). Additional exceptions apply. Note: The type of income is not required if the amount of income is $0 - $200 or if the asset qualifies as an excepted investment fund (EIF). 7. Transactions Part 7 discloses purchases, sales, or exchanges of real property or securities in excess of $1,000 made on behalf of the filer, the filer's spouse or dependent child during reporting period. This section does not include transactions that concern the following: (1) a personal residence, unless rented out; (2) cash accounts (e.g., checking, savings, CDs, money market accounts) and money market mutual funds; (3) Treasury bills, bonds, and notes; and (4) holdings within a federal Thrift Savings Plan account. Additional exceptions apply. Source: https://www.industrydocuments.ucsf.edu/docs/jsbn0226 8. Liabilities Part 8 discloses liabilities over $10,000 that the filer, the filer's spouse or dependent child owed at any time during the reporting period. This section does not include the following types of liabilities: (1) mortgages on a personal residence, unless rented out (limitations apply for PAS filers); (2) loans secured by a personal motor vehicle, household furniture, or appliances, unless the loan exceeds the item's purchase price; and (3) revolving charge accounts, such as credit card balances, if the outstanding liability did not exceed $10,000 at the end of the reporting period. Additional exceptions apply. 9. Gifts and Travel Reimbursements This section discloses: Gifts totaling more than $375 that the filer, the filer's spouse, and dependent children received from any one source during the reporting period. Travel reimbursements totaling more than $375 that the filer, the filer's spouse, and dependent children received from any one source during the reporting period. For purposes of this section, the filer need not aggregate any gift or travel reimbursement with a value of $150 or less. Regardless of the value, this section does not include the following items: (1) anything received from relatives; (2) anything received from the United States Government or from the District of Columbia, state, or local governments; (3) bequests and other forms of inheritance; (4) gifts and travel reimbursements given to the filer's agency in connection with the filer's official travel; (5) gifts of hospitality (food, lodging, entertainment) at the donor's residence or personal premises; and (6) anything received by the filer's spouse or dependent children totally independent of their relationship to the filer. Additional exceptions apply. Source: https://www.industrydocuments.ucsf.edu/docs/jsbn0226

What does EIF stand for?

jsbn0226

jsbn0226_p6, jsbn0226_p7, jsbn0226_p8

EXCEPTED INVESTMENT FUND, Excepted Investment Fund.

Summary of Contents 1. Filer's Positions Held Outside United States Government Part 1 discloses positions that the filer held at any time during the reporting period (excluding positions with the United States Government). Positions are reportable even if the filer did not receive compensation. This section does not include the following: (1) positions with religious, social, fraternal, or political organizations; (2) positions solely of an honorary nature; (3) positions held as part of the filer's official duties with the United States Government; (4) mere membership in an organization; and (5) passive investment interests as a limited partner or non-managing member of a limited liability company. 2. Filer's Employment Assets & Income and Retirement Accounts Part 2 discloses the following: Sources of earned and other non-investment income of the filer totaling more than $200 during the reporting period (e.g., salary, fees, partnership share, honoraria, scholarships, and prizes) Assets related to the filer's business, employment, or other income-generating activities that (1) ended the reporting period with a value greater than $1,000 or (2) produced more than $200 in income during the reporting period (e.g., equity in business or partnership, stock options, retirement plans/accounts and their underlying holdings as appropriate, deferred compensation, and intellectual property, such as book deals and patents) This section does not include assets or income from United States Government employment or assets that were acquired separately from the filer's business, employment, or other income-generating activities (e.g., assets purchased through a brokerage account). Note: The type of income is not required if the amount of income is $0 - $200 or if the asset qualifies as an excepted investment fund (EIF). 3. Filer's Employment Agreements and Arrangements Part 3 discloses agreements or arrangements that the filer had during the reporting period with an employer or former employer (except the United States Government), such as the following: Future employment Leave of absence Continuing payments from an employer, including severance and payments not yet received for previous work (excluding ordinary salary from a current employer) Continuing participation in an employee welfare, retirement, or other benefit plan, such as pensions or a deferred compensation plan Retention or disposition of employer-awarded equity, sharing in profits or carried interests (e.g., vested and unvested stock options, restricted stock, future share of a company's profits, etc.) 4. Filer's Sources of Compensation Exceeding $5,000 in a Year Part 4 discloses sources (except the United States Government) that paid more than $5,000 in a calendar year for the filer's services during any year of the reporting period. Source: https://www.industrydocuments.ucsf.edu/docs/jsbn0226 The filer discloses payments both from employers and from any clients to whom the filer personally provided services. The filer discloses a source even if the source made its payment to the filer's employer and not to the filer. The filer does not disclose a client's payment to the filer's employer if the filer did not provide the services for which the client is paying. 5. Spouse's Employment Assets & Income and Retirement Accounts Part 5 discloses the following: Sources of earned income (excluding honoraria) for the filer's spouse totaling more than $1,000 during the reporting period (e.g., salary, consulting fees, and partnership share) Sources of honoraria for the filer's spouse greater than $200 during the reporting period Assets related to the filer's spouse's employment, business activities, other income-generating activities that (1) ended the reporting period with a value greater than $1,000 or (2) produced more than $200 in income during the reporting period (e.g., equity in business or partnership, stock options, retirement plans/accounts and their underlying holdings as appropriate, deferred compensation, and intellectual property, such as book deals and patents) This section does not include assets or income from United States Government employment or assets that were acquired separately from the filer's spouse's business, employment, or other income-generating activities (e.g., assets purchased through a brokerage account). Note: The type of income is not required if the amount of income is $0 - $200 or if the asset qualifies as an excepted investment fund (EIF). Amounts of income are not required for a spouse's earned income (excluding honoraria). 6. Other Assets and Income Part 6 discloses each asset, not already reported, that (1) ended the reporting period with a value greater than $1,000 or (2) produced more than $200 in investment income during the reporting period. For purposes of the value and income thresholds, the filer aggregates the filer's interests with those of the filer's spouse and dependent children. This section does not include the following types of assets: (1) a personal residence (unless it was rented out during the reporting period); (2) income or retirement benefits associated with United States Government employment (e.g., Thrift Savings Plan); and (3) cash accounts (e.g., checking, savings, money market accounts) at a single financial institution with a value of $5,000 or less (unless more than $200 of income was produced). Additional exceptions apply. Note: The type of income is not required if the amount of income is $0 - $200 or if the asset qualifies as an excepted investment fund (EIF). 7. Transactions Part 7 discloses purchases, sales, or exchanges of real property or securities in excess of $1,000 made on behalf of the filer, the filer's spouse or dependent child during reporting period. This section does not include transactions that concern the following: (1) a personal residence, unless rented out; (2) cash accounts (e.g., checking, savings, CDs, money market accounts) and money market mutual funds; (3) Treasury bills, bonds, and notes; and (4) holdings within a federal Thrift Savings Plan account. Additional exceptions apply. Source: https://www.industrydocuments.ucsf.edu/docs/jsbn0226 8. Liabilities Part 8 discloses liabilities over $10,000 that the filer, the filer's spouse or dependent child owed at any time during the reporting period. This section does not include the following types of liabilities: (1) mortgages on a personal residence, unless rented out (limitations apply for PAS filers); (2) loans secured by a personal motor vehicle, household furniture, or appliances, unless the loan exceeds the item's purchase price; and (3) revolving charge accounts, such as credit card balances, if the outstanding liability did not exceed $10,000 at the end of the reporting period. Additional exceptions apply. 9. Gifts and Travel Reimbursements This section discloses: Gifts totaling more than $375 that the filer, the filer's spouse, and dependent children received from any one source during the reporting period. Travel reimbursements totaling more than $375 that the filer, the filer's spouse, and dependent children received from any one source during the reporting period. For purposes of this section, the filer need not aggregate any gift or travel reimbursement with a value of $150 or less. Regardless of the value, this section does not include the following items: (1) anything received from relatives; (2) anything received from the United States Government or from the District of Columbia, state, or local governments; (3) bequests and other forms of inheritance; (4) gifts and travel reimbursements given to the filer's agency in connection with the filer's official travel; (5) gifts of hospitality (food, lodging, entertainment) at the donor's residence or personal premises; and (6) anything received by the filer's spouse or dependent children totally independent of their relationship to the filer. Additional exceptions apply. Source: https://www.industrydocuments.ucsf.edu/docs/jsbn0226

When is the Written Statement dated on?

zlcn0226

zlcn0226_p0, zlcn0226_p1, zlcn0226_p2, zlcn0226_p3, zlcn0226_p4, zlcn0226_p5, zlcn0226_p6, zlcn0226_p7, zlcn0226_p8, zlcn0226_p9, zlcn0226_p10, zlcn0226_p11, zlcn0226_p12, zlcn0226_p13, zlcn0226_p14, zlcn0226_p15, zlcn0226_p16, zlcn0226_p17

March 9, 2017

American' Chemistry Council Written Statement of Nancy B. Beck, Ph.D., DABT Senior Director of Regulatory & Technical Affairs American Chemistry Council Before the U.S. Senate Committee on Homeland Security and Governmental Affairs Subcommittee on Regulatory Affairs and Federal Management Regarding a Hearing on the Agency Use of Science in the Rulemaking Process: Proposals for Improving Transparency and Accountability March 9, 2017 American Chemistry Council 700 2nd Street, N.E. Washington, D.C. 20002 1 I Page Source: https://www.industrydocuments.ucsf.edu/docs/zlcn0226 Summary The American Chemistry Council (ACC¹ appreciates this opportunity to provide testimony on Federal Agency use of science in the rulemaking process, and particularly on proposals for improving transparency and accountability. The business of chemistry is a critical component for manufacturing safe, high quality products and ACC member companies rely on science to conduct the research necessary to discover new chemistries and identify new applications of existing chemistries. They also rely on science to develop new tools for assessing the potential hazards, exposures and risks of chemical substances. Similarly, they expect high quality, up to date science and relevant reliable assessment processes to underpin regulatory decisions by the Federal government. Reliance on the highest quality, best available science is critical to ensuring public trust. Without it, consumers are at a severe disadvantage. Stakeholders can lose confidence in regulatory decision making, which in turn can lead to product de-selection that is not supported by science, unwarranted public alarm and unnecessary costs. ACC supports actions to enhance the integration of the best available scientific knowledge and weight of the evidence methods as the foundation for regulatory decision making across Federal Agencies. We also support improving the technical quality and objectivity of Agency evaluations, particularly through enhancing the transparency of how the science is being considered, interpreted, and evaluated. In 2002, Federal Agencies were directed to ensure the quality, objectivity, utility and integrity of information which they disseminated to the public.² In theory, this should have had a direct impact on improving the quality of scientific analyses that support regulatory decisions. Unfortunately, while most Agencies have committed to meeting these standards, we have seen that some of the scientific analyses that have come out of the EPA and other Federal Agencies fall short of meeting the objectivity and quality standards discussed in the government-wide Information Quality Guidelines. 1 ACC represents the leading companies engaged in the business of chemistry. ACC members apply the science of chemistry to make innovative products and services that make people's lives better, healthier and safer. ACC is committed to improved environmental, health and safety performance through Responsible Care®, common sense advocacy designed to address major public policy issues, and health and environmental research and product testing. The business of chemistry is a $797 billion enterprise and a key element of the nation's economy. It is the nation's largest exporter, accounting for fourteen percent of all U.S. exports. It is also one of the nation's most heavily regulated industries. Chemistry companies are among the largest investors in research and development. 2 Pursuant to what is commonly referred to as the Information Quality Act (Sec. 515 of the Treasury and General Government Appropriations Act for FY 2001, Pub. L. No. 106-554), the Office of Management and Budget (OMB) issued government-wide Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies (2002), 67 Fed. Reg. 8452 (Feb. 22, 2002) [hereinafter Information Quality Guidelines], available at: https://georgewbush-whitehouse.archives.gov/omb/memoranda/fy2007/m07-24.pdf; 2 I Page Source: https://www.industrydocuments.ucsf.edu/docs/zlcn0226 ACC's testimony today discusses some of the standards that already exist, discusses the new Lautenberg Chemical Safety Act scientific standards, and provides some suggestions for ensuring the quality of science that supports regulatory activities. We also share examples of where some Agencies' scientific evaluations continue to fall short. I. The Need for Confidence in Science As we are all aware from the news media, there is a large public perception that science may not inform Federal Agency decision making. Indeed even organizations like the American Association for the Advancement of Science (AAAS) have now become official partners in the planned April 22, 2017 March for Science. Dr. Rush Holt, the CEO of AAAS has stated "We see the activities collectively known as the March as a unique opportunity to communicate the importance, value and beauty of science." Concerns about confidence in science, particularly to inform regulations, is not new and certainly did not begin with the 2016 elections. In 2013, George Mason University conducted a survey to help capture the viewpoints of the scientific community on the state of regulatory risk assessment. The survey "Expert Opinion on Regulatory Risk Assessment" reached out to all members of the Society of Toxicology Risk Assessment Specialty Section, the Society for Risk Analysis Dose Response Section and the International Society for Regulatory Toxicology and Pharmacology. 4 The survey focused on how well and how frequently critical parts of a risk evaluation were conducted (e.g., was there a problem formulation, were standardized protocols used for data collection, was a weight of evidence approach used, was peer review sufficient). In general, the findings showed that there is widespread concern over the current application of these procedures and also showed concerns about the amount of attention given to scientific factors in risk management.5 In July 2016, almost 200 toxicologists signed "an appeal for the integrity of science in public policy." This appeal urges legislators to embed the "rules of evidence" of the scientific method in statutes governing administrative policy and regulations. These scientists are concerned that precautionary regulations and policies are being presented as objective science, when in reality they are not. In another recent article, Dr. Andrew Rosenberg of the Union of Concerned Scientists stated, "When science is sidelined from policy decisions, we all lose."7 ACC shares the concerns and recommendations of this diverse set of scientists. Too often we see scientific assessments, or even policies, that are driven by default assumptions rather than actual scientific evidence. 8 ACC has consistently called upon the EPA to improve the design and conduct of its chemical assessments. In 2014, ACC released Principles for Improving Chemical Hazard and Risk 3 See Science Magazine, Feb 28, 2017 article available at: uttp:llwww.sciencemag.org/new/2017/02/will-they-or- won-t-theywhat-science-groups-are-saying-about-joining-march-science. 4 The Survey and results can be found at: https://cmpa.gmu.edu/wp-content/uploads/2013/12/GMU-Study Report.pdf. 5 Ibid at page 2. 6 See article available at: http://www.sciencedirect.com/science/article/pii/S0300483X16301123. 7 See Science Magazine, Feb 17, 2017 article available at: http://science.sciencemag.org/content/355/6326/696/tab pdf. 8 See NIOSH Carcinogen Policy example provided in Appendix 1 of this testimony. 3 a 8 Source: https://www.industrydocuments.ucsf.edu/docs/zlcn0226 Assessments.9 ACC did not invent these principles. For years, authoritative bodies, like the National Academy of Sciences (NAS), have provided similar constructive input to the EPA. 10 Appendix 1 of this testimony provides some specific examples of cases where Federal Agency evaluations have not met scientific standards. II. Tools and Standards Exist to Improve Agency Science Improving Federal Agency science should not be as challenging as it has been. Significant governmental and non-governmental guidance already exists. As noted below, often this guidance is not followed. a. Information Quality Guidelines In 2002, the Office of Management and Budget (OMB) released the Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies (Information Quality Guidelines). 11 The guidelines were then adopted by Federal Agencies and the OMB's principles were to be reflected in the agency-specific guidelines. With regard to the analysis of risks to human health, safety and the environment, Agencies have adopted or adapted the quality principles applied by Congress to risk information used and disseminated pursuant to the Safe Drinking Water Act (SDWA) Amendments of 1996 (42 U.S.C. 300g-1(b)(3)(A) & (B)). In these amendments, Congress emphasized that EPA must use the best available scientific evidence for risk information. Since the Information Quality Guidelines directed all Agencies to adopt this standard, Agencies were directed, "to the degree that an Agency action is based on science," to use: (i) the best available, peer-reviewed science and supporting studies conducted in accordance with sound and objective scientific practices; and (ii) data collected by accepted methods or best available methods (if the reliability of the method and the nature of the decision justifies use of the data). Additionally, the 1996 SDWA amendments directed EPA "to ensure that the presentation of information [risk] effects is comprehensive, informative, and understandable." The Information Quality Guidelines adopted this language and directed all Agencies: [I]n a document made available to the public in support of a regulation [to] specify, to the extent practicable:12 9 See ACC principles available at: https://www.americanchemistry.com/Chemical-Hazard-and-Risk-Assessmen Principles/ and further details at: https://www.americanchemistry.com/Policy/Chemical-Safety/Chemical- Assessments/Principles.pdf. 10 See for instance chapter 7 in the 2011 NAS Review of the Environmental Protection Agency's Draft IRIS Assessment of Formaldehyde available at: https://www.nap.edu/catalog/13142/review-of-the-environmental- protection-agencys-draft-iris-assessment-of-formaldehyde. 11 The Information Quality Guidelines are available at: https://georgewbush- hitehouse.archives.gov/omb/memoranda/fy2007/m07-24.pdf. 12 Bracketed language reflects changes to text for clarity. 4|Page Source: :ttps://www.industrydocuments.ucsf.edu/docs/zlcn0226 (i) each population addressed by any estimate [of applicable risk effects]; (ii) the expected risk or central estimate of risk for the specific populations [affected]; (iii) each appropriate upper-bound or lower-bound estimate of risk; (iv) each significant uncertainty identified in the process of the assessment of [risk] effects and the studies that would assist in resolving the uncertainty; and (v) peer-reviewed studies known to the [agency] that support, are directly relevant to, or fail to support any estimate of [risk] effects and the methodology used to reconcile inconsistencies in the scientific data. b. Memorandum on Updated Principles for Risk Analysis In 2007, OMB and the Office of Science and Technology Policy (OSTP) issued a joint memorandum to Executive Departments and Agencies on Updated Principles for Risk Analysis (Principles for Risk Analysis). 13 This memorandum was intended to reinforce the principles developed in 1995. While the focus was on actions directed at improving public health, safety, and the environment, it was noted that many of the principles were relevant to other fields, such as financial or information technology risk analyses. The Principles for Risk Analysis reiterated the requirements for best available science as they were articulated in the Information Quality Guidelines and presented further important information regarding the use of and presentation of assumptions, judgments, and uncertainties in risk analyses. For instance, among other requirements, the Principles for Risk Analysis require that: Judgments used in developing a risk assessment, such as assumptions, defaults, and uncertainties, should be stated explicitly. The rationale for these judgments and their influence on the risk assessment should be articulated.¹ 14 Results based on different effects and/or different studies should be presented to convey how the choice of effect and/or study influences the analysis. The presentation of information regarding different scientifically plausible endpoints should allow for a robust discussion of the available data, associated uncertainties, and underlying science. 15 Due to the inherent uncertainties associated with estimates of risk, presentation of a single estimate may be misleading and provide a false sense of precision. Expert panels agree that when a quantitative characterization of risk is provided, a range of plausible risk estimates should be provided. 16 13 See: https://georgewbush-whitehouse.archives.gov/omb/memoranda/fy2007/m07-24.pdf. 14 Ibid, at page 8. 15 Ibid, at page 8. 16 Ibid, at page 6. 5 P a g e Source: https://www.industrydocuments.ucsf.edu/docs/zlcn0226 c. Non-Governmental Reports on Improving Science in Regulations Improving Peer Review: In addition to government guidance, other consensus groups have spoken to the needs for ensuring high quality science. For instance, in 2009 the Bipartisan Policy Center put out a report entitled "Improving the Use of Science in Regulatory Policy."17 Important recommendations in this report included: The Administration needs to promulgate guidelines (through executive orders or other instruments) to ensure that when federal agencies are developing regulatory policies, they explicitly differentiate, to the extent possible, between questions that involve scientific judgments and questions that involve judgments about economics, ethics and other matters of policy. 18 The federal government, universities, scientific journals and scientists themselves can help improve the use of science in the regulatory process by strengthening peer review, expanding the information available about scientific studies, and setting and enforcing clear standards governing conflict of interest. 19 In 2012, the Keystone Center released a report entitled "Improving the Use of Science in Regulatory Decision-Making.*20 This report stressed the importance of consistency and transparency in selecting peer review panels and also noted that the regulatory process is better when there is a consistent, transparent and systematic review and evaluation of the scientific literature. The importance of a robust peer review process cannot be underestimated. Peer review is essential in the evaluation of scientific information to ensure the development of scientifically defensible assessments. It allows for the review of the underlying assumptions, methodology, criteria, and conclusions reached in the evaluation. Federal Agencies have several mechanisms available to them to conduct peer review of scientific information; however, these peer review processes and approaches are inconsistently applied, including the selection of peer review panel members and the consideration given to public and peer review comments. For example, during some EPA peer review meetings, the peer reviewers have appeared to be overly deferential to EPA and reluctant to be seen as criticizing EPA staff. We have also seen situations where peer reviewers have suggested discounting a study solely based on the funding source, without any consideration of the quality of the study. Also, EPA staff often comment throughout peer review meetings, essentially participating as peers, while stakeholders, including industry experts, are typically excluded from the 17 See: http://cdn.bipartisanpolicy.org/wp-content/uploads/sites/default/files/BPC%20Science%20Report%2Oful.pdf 18 Ibid, at page 4. 19 Ibid, at page 45. 20 See: ttps://www.keystone.org/wp-content/uploads/2015/08/091812-Research-Integrity-Roundtable-Report.pdf 6 Page Source: https://www.industrydocuments.ucsf.edu/docs/zlcn0226 dialogue. This practice undermines the integrity of the reviewers' role as independent and external to the assessment itself. Additionally, a critical element of peer review is the consideration of public comments. The public plays an important role in the review process by helping identify key scientific information and potential concerns with the assessment being evaluated. Unfortunately, within some Agencies, there is no robust consideration of public comments in the peer review process. For example, reviewers on the EPA Science Advisory Board (SAB) are not given clear advice regarding what it means to "consider" public comments. In fact we have seen SAB chairs ignore public input because they are not required to address it. When this has occurred, SAB staff have not clarified to the peer reviewers that they can and should respond to public input. Improving Systematic Review: The importance of systematic review in risk evaluation was mentioned in the 2012 Keystone Center report, and emphasized in a 2014 NAS report of its Review of EPA's Integrated Risk Information System (IRIS) Process. 21 This NAS panel noted that the use of systematic review approaches would "substantially strengthen" the IRIS process at EPA. Unfortunately, we have yet to see the IRIS program release an assessment that is consistent with these NAS recommendations. Data Access and the Protection of Confidential Business Information: Both the Bipartisan Policy Center report and the Keystone Center report discuss the need to protect proprietary business information. The legitimate need for protection must be balanced against public interest in the disclosure of relevant studies and data for the purposes of reproducibility. 22 The OMB Information Quality Guidelines recognize this tension and note that Even in a situation where the original and supporting data are protected by confidentiality concerns, or the analytic computer models or other research methods may be kept confidential to protect intellectual property, it may still be feasible to have the analytic results subject to the reproducibility standard. When it comes to environmental, health and safety information about chemicals, the Toxic Substances Control Act (TSCA) requires that EPA have access to that information. ACC member companies' current practice is to share summary results of industry studies with EPA or to provide raw data underlying health, safety and environmental studies with EPA upon request. Thus the Agency has the information it needs to ensure the safe regulation of chemicals, and EPA can rely on this information in its regulatory decisions. While any proprietary information must be protected, there are processes that exist to make robust study summary information available to the public in a manner that is sufficient to ensure public understanding of the data and address transparency demands. When it comes to full disclosure to the public, decisions to share raw data with non- regulatory bodies are made on a case by case basis. Companies weigh factors such as the 21 See: http://dels.nas.edu/Report/Review-Integrated-Risk/18764. 22 See the Keystone Center report at page 20. 7 I P a Source: https://www.industrydocuments.ucsf.edu/docs/zlcn0226 potential health/environmental impact of the product, the commercial value of the data, the age of the data, and other administrative, ethical, financial, legal, technical, and public health considerations. III. Science Standards in the 2016 Lautenberg Chemical Safety Act When the Lautenberg Chemical Safety for the 21st Century Act (LCSA23 was passed in 2016, it was the first time Congress directed a Federal Agency to consider not only the best available science but also the weight of the scientific evidence (WoE). These scientific standards, added to TSCA in Section 26 of the LCSA, have a prominent role in ensuring the Act achieves the fundamental objective of improving public confidence in the federal regulatory system. EPA now has a mandate to apply high quality, reliable and relevant scientific information. To date, EPA appears to be interpreting these scientific standards as implying that "business as usual" is consistent with the standards. EPA is reluctant to explicitly incorporate the best available science and WoE standards into the framework rules that it is developing to implement the LCSA. Instead, the Agency has suggested that simple reliance on existing guidelines and current practices are sufficient to meet the standards in Section 26. 24 This is of great concern to ACC. For example, Section 26(i) of the LCSA requires that EPA make decisions using a WoE approach. While a definition of WoE is not provided in the statute, the June 7 Congressional Record provides a definition that was entered into the record by Senator Boxer, the ranking minority member on the committee: Weight of the evidence means a systematic review method that uses a pre-established protocol to comprehensively, objectively, transparently, and consistently, identify and evaluate each stream of evidence, including strengths, limitations, and relevance of each study and to integrate evidence as necessary and appropriate based upon strengths, limitations, and relevance.25 This definition is also consistent with the June 2015 House Report language.26 Importantly, the definition refers to using a systematic review approach, as has been recommended by the Keystone Center report and the NAS in 2014. It also suggests that evidence be judged on its quality. Notably, EPA's proposed risk evaluation rule does not incorporate this definition. EPA has asked, however, for comment on this approach. 23 P.L. 114-182, 130 Stat. 448 (June 22, 2016). 24 EPA's draft framework rules for prioritization and risk evaluation can be found at: https://www.epa.gov/assessing. and-managing-chemicals-under-tsca/frank-r-lautenberg-chemical-safety-21st-century-act-5. 25 See Senate Congressional Record, June 7, 2016 at page S3518, available at: ttps://www.congress.gov/crec/2016/06/07/CREC-2016-06-07-pt1-PgS3511.pdf. 26 See House Report at page 33, available at: https://www.congress.gov/114/crpt/hrpt176/CRPT-114hrpt176.pdf 8 Page Source: https://www.industrydocuments.ucsf.edu/docs/zlcn0226 A recent example demonstrates that EPA apparently does not interpret WoE in the same way Congress did in the LCSA. In the draft risk assessment of 1-bromopropane (released prior to enactment of LCSA), EPA did not conduct a systematic review, and the draft assessment did not provide information regarding the quality of the individual studies. 27,28 Although the assessment identified some quality considerations, EPA did not provide any information regarding its own findings from its quality review of the individual studies. 29,30 Additionally, EPA did not describe how considerations were applied and what constitutes a study of "high quality" or "good quality." While EPA staff orally noted that they followed a WoE approach,31 EPA simply chose the value that provided the lowest point of departure and thus would be most health protective. The 1-bromopropane draft risk assessment is not consistent with the best available science or the WoE approach envisioned under the LCSA. If EPA chooses to simply follow current practices, the Agency will embark on a process that is not consistent with the new Section 26 science standards. Section 26 requires EPA to develop, within two years of enactment, any new policies, procedures and guidance that are necessary to ensure compliance with the LCSA. In addition, within five years of enactment and then once every five years, EPA is required to review these policies, procedures and guidance. This approach will ensure that EPA is consistently relying upon scientific approaches that are consistent with the state of the science. IV. Potential Solutions to Improving Agency Science ACC provides the following four recommendations to improve the science supporting regulatory decision making. a. Improve and Clarify Scientific Definitions ACC believes that the intent of Congress in drafting the scientific standards in the LCSA is clear. It is also clear that EPA's proposed interpretation diverges from Congressional intent in important respects. Clarifying that the intent of scientific standards is to improve existing Agency practices would be useful. In addition, providing clear and specific definitions for terms like best available science and WoE would be beneficial to the consistency, reliability and credibility of EPA's regulatory decisions. These definitions should address not only what Agencies should consider when evaluating scientific information, but also what information 27 See Comments of the American Chemistry Council on the TSCA Work Plan Chemical Draft Risk Assessment of I-Bromopropane Docket No. EPA-HQ-OPPT-2015-0084, May 9, 2016. 28 See peer review report/meeting minutes available at: https://www.regulations.gov/document?D=EPA-HQ-OPPT- 2015-0805-0028, at page 41 which states: "While the Agency indicates that the literature was thoroughly reviewed for robustness, adequacy, etc., the Committee found that it is not clear what exact methodology was used to systematically rate, rank, and select studies to inform sections of the risk assessment. For example, was a quantitative ranking system developed for study quality?" 29 Ibid. 30 See draft available at: :https://www.epa.gov/sites/production/files/2016-03/documents/1- bp report and appendices final.pdf at Appendix M. 31 See Chemical Safety Advisory Committee Meeting Transcript available at: https://www.regulations.gov/document?D=EPA-HQ-OPPT-2015-0805-0027;at page 130. 9 Page Source: https://www.industrydocuments.ucsf.edu/docs/zlcn0226 Agencies should present in evaluations. Requiring the Agencies to "show their work" and present their thought process in a transparent and clear manner would be have tremendous value. For example, adopting the language from the SDWA Amendments, we suggest the following definition of best available science: Best available science means information that has been evaluated based on its strengths, limitations and relevance and that the Agency is relying on the highest quality information. In evaluating best available science, the Agency will also consider the peer review of the science, whether the study was conducted in accordance with sound and objective practices, and if the data were collected by accepted methods or best available methods. To ensure transparency regarding best available science the Agency will describe and document any assumptions and methods used, and address variability, uncertainty, the degree of independent verification and peer review. Defining WoE clearly would also be advantageous. As noted previously, we suggest the definition articulated in the Senate debate on LCSA on June 7, 2016. When using this definition, it will also be important to clearly define the term "systematic review" as there may not be a uniform interpretation of that term among stakeholders. A particular concern in applying the best available science and weight-of-the-evidence is the tendency of federal agencies to use default assumptions, even when data are available. Despite more than 30 years of extensive mechanistic toxicological research by academia, research institutions and the private sector, some regulatory programs in EPA continue to rely on default approaches for hazard characterizations and risk assessments that date back to the 1970s. Even though frameworks for integrating mechanistic information and mode of action have been developed by authoritative bodies and incorporated into the EPA cancer risk guidelines, 32 at the present time, there is uneven use within EPA of such approaches in hazard characterizations and risk assessments. EPA's Office of Pesticide Programs has often determined, based on WoE evaluations that include consideration of mode of action and human relevance, that carcinogenic effects in animal studies are not relevant to humans or the carcinogenic effects are secondary to target organ toxicity, and thus no carcinogenic risks are posed to humans at doses below those which produce such toxicities. However, the IRIS program continues to rely on the 1970s default linear approach for cancer risk assessment. The IRIS program steadfast reliance on default linear approaches has significant consequences for many chemicals and can create tremendous costs to address "phantom risks" in site cleanups. 33 This outdated manner in which the EPA IRIS program deals with mode of action knowledge does not comport with use of best available science. Therefore, in implementing the definitions of best available science and WoE for the evaluation of the potential carcinogenic effects of substances, when supported by the scientific data, EPA should present non-linear modeling approaches consistent with the available data and scientific understanding of endogenous exposures and mode of action, in lieu of, or at a minimum in addition to, a linear default. Further, such assessments should include, in addition to upper 32 See EPA 2005 Guidelines for Carcinogen Risk Assessment 33 See George M. Gray and Joshua T. Cohen Nature 489, 27-28, 06 September 2012. 10 Page Source: https://www.industrydocuments.ucsf.edu/docs/zlcn0226 bound calculations, the distribution of estimated hazards or risks, including central tendency values, and clear criteria for when defaults are justified, including criteria for the application of uncertainty factors. b. Improve Oversight and Develop Quality Checklists Considering the guidance that already exists from OMB, other consensus bodies, and within the Agencies, stronger oversight to ensure that Agencies are following existing guidance could be highly effective. This oversight could come from independent offices within Agencies, Congress, or OMB or OSTP within the Executive Office of the President. One tool that may be effective is to develop a checklist to ensure that quality standards are met in scientific evaluations that support regulations. For instance, a recent publication from former EPA scientists has suggested that to promote transparency and consistency, risk evaluations could be compared to a guide or checklist which depicts all the important elements of a high quality assessment.34 Drs. Dellarco and Fenner-Crisp suggest that this guide "could be used by authors, sponsors, risk assessors, peer reviewers, and other interested stakeholders to determine if an assessment meets the current best scientific practices."355 c. Improve Peer Review Practices As noted earlier, the importance of a robust peer review process cannot be underestimated. Ensuring that peer review panels are composed of a diverse group of experts that have the breadth and depth of experience necessary to review scientific analyses in a transparent and comprehensive manner would be beneficial. It is also important to ensure that peer reviewers are fully independent from the program office issuing the assessment and conflicts of interest are fully evaluated and disclosed. More details on improving peer review can be found in the OMB Information Quality Bulletin for Peer Review, 36 as well as in reports from other consensus bodies, as discussed in Section II. d. Change Publication Incentives and Standards for Scientific Grants and Funding Much has been written about the lack of reproducibility of research findings published in peer reviewed journals. 37 The trend towards "publish or perish" puts immense pressure on researchers to publish findings, and in particular to publish predominantly positive findings. 38 Publication bias is common to published academic literature. This leads to bodies of literature in which the majority of publications support a given hypothesis. Publication bias stems from the fact there are many fewer incentives for publishing negative information or information that does 34 See publication available at: https://ehp.niehs.nih.gov/15-10483/. 35 Ibid 36 See: ttps://www.gpo.gov/fdsys/pkg/FR-2005-01-14/pdf/05-769.pdf. 37 See for example: http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.0020124,or http://www.nature.com/news/reproducibility-1.17552 38 See for example: :https://www.ncbi.nlm.nih.gov/pme/articles/PMC3999612/. 11 Page Source: https://www.industrydocuments.ucsf.edu/docs/zlcn0226 not support a hypothesis. Promotions and job security in academia, as well as having grants funded by Federal Agencies, are often tied to an author's publication record. Government Agencies can play an important role by 1) changing the incentives for grant funding such that decisions to fund research do not depend so heavily upon finding positive results and 2) putting in place standards to ensure that research studies are designed in a manner that will make them useable for regulatory decision making. Standards for funding could ensure that research studies follow best scientific practices and are designed with regulatory use in mind. For instance, for chemical risk assessment, studies should be designed to test more than three doses such that a dose-response analysis can be conducted. Unfortunately we have seen too many examples of government funded research where only one high dose is tested. While this information may have some value, it is then difficult to use these data to determine what impact the same chemical may have at more environmentally relevant lower dose ranges. If the government demanded a more robust study design when approving the research projects, the data obtained would likely be much more useful. V. Conclusion Ensuring that Federal decision making is firmly based on the use of high quality science is critical to helping the government meet its obligation to protect human health and the environment. This can be achieved through common sense reforms that will lead to more efficient and effective regulatory decisions. ACC looks forward to working with members of the Committee to enhance approaches to ensure that high quality science is the foundation to regulatory decision making. 12 I Page Source: https://www.industrydocuments.ucsf.edu/docs/zlcn0226 Appendix 1: Examples of Scientific Concerns with Federal Science Evaluations Below ACC provides a few specific examples where Federal Agencies have fallen short when it comes to using the best available science. a. Case 1: OSHA Crystalline Silica PEL Background OSHA finalized its workplace Permissible Exposure Limit (PEL) for crystalline silica in March, 2016. The final PEL reduced the standard from 100 g/m³ to 50 g/m³. Crystalline silica (commonly encountered as beach sand) is the second most abundant mineral in the Earth's crust. It is ubiquitous in rocks, gravel, sand and soils; plays a crucial role in construction and transportation; and is essential for many manufacturing processes and countless products. For example, it is a critical material for foundries and steel making, and is a key component of abrasives, paints, high-tech equipment, glass and ceramics. OSHA contended that the PEL of 100 g/m³ was not sufficiently protective. In fact, however, the data clearly shows that the incidence and rate of silicosis mortality have declined dramatically since adoption of the 100 g/m³ PEL in 1971, and the remaining cases can be attributed to higher silica exposures that were prevalent decades ago (allowing for latency) and to exceedances of the 100 g/m³ PEL. Moreover, the best evidence indicates that for silicosis and other potential pulmonary diseases, including lung cancer, there is a concentration-based threshold for silica exposure that exceeds 100 g/m³. Importance The new PEL is not economically feasible across multiple sectors of general industry and therefore will cause significant economic disruption throughout the economy. OSHA estimated that the annualized costs for all of general industry to comply with the revised standard would be $359 million. That estimate of compliance costs is deeply flawed and vastly understates the true costs of compliance, which are likely to be more than an order of magnitude higher. It would be far more cost-efficient and effective to bring all general industry employers into compliance with the longstanding PEL of 100 g/m³ rather than mandating that they attempt to comply with the new PEL of 50 g/m³. Scientific Concerns Because of its long latency period, silicosis cases seen today are attributable largely to exposures that occurred decades ago - in most cases, to exposures that began before OSHA's long-standing PEL of 100 g/m³ was even adopted. OSHA's argument that silicosis cases are underreported does not alter the fact that silicosis cases have dropped dramatically in the previous 40+ years, as silicosis cases have been underreported relatively consistently through that same time period. There are fundamental shortcomings and limitations in OSHA's risk assessment for all of OSHA's identified endpoints of concern: Important statistical errors in modeling and inference, including in particular a failure to adequately control for biases, which can lead to false positive results. 13 I Page Source: https://www.industrydocuments.ucsf.edu/docs/zlcn0226 A failure to properly model exposure measurement errors, which are common in the silica worker cohort studies in particular. Generally, uncertainties are not well characterized in the preliminary quantitative risk assessment. A failure by OSHA to carry out any causal modeling or analysis that would allow it to conclude that a reduction in the PEL would actually reduce adverse health effects. The alleged association between silica exposure per se and lung cancer remains controversial in the scientific community. OSHA did not properly weigh and consider the totality of the epidemiological evidence, discounting the significance of negative studies while choosing to highlight those studies that would confirm OSHA's position. Furthermore, as noted above, the best evidence points to an exposure concentration threshold for potential silica-related lung cancer that exceeds the PEL of 100 g/m³ that applied in general industry before the new rule was adopted in 2016. b. Case 2: EPA IRIS Assessment of Trimethylbenzenes (TMB) Background On September 9, 2016, EPA issued its final report on the IRIS assessment of Trimethylbenzenes (TMBs), which addresses the potential non-cancer and cancer human health effects from long- term exposure to TMBs. Humans are not exposed to individual TMB compounds, but to complex mixtures. According to EPA, the primary uses for TMBs are as a blending agent in gasoline formulations (C9 aromatic fraction); solvents; and as a paint thinner. In its review of TMBs, the EPA fell far short in meeting its obligations to improve its IRIS processes and assessment reports. Without explanation, EPA failed to respond to public comments on the draft TMBs assessment, even though the IRIS process for developing assessments explicitly includes a response to comments element. Importance As a final report, the IRIS assessment on TMBs will inform risk management decisions on TMBs by EPA's program and regional offices. Scientific Concerns The IRIS assessment of TMBs does not accurately represent the health effects associated with exposure to TMBs because EPA failed to utilize a consistent and transparent data evaluation procedure for evaluating and weighing the full body of evidence. In particular, EPA failed to rely on available guideline studies on commercial complex C9 aromatic mixtures that industry conducted under EPA's TSCA program. The entire commercial C9 aromatic blend, which contains a high percentage of TMBs, has similar toxicological properties and health effects as the individual isomers of TMB. Thus, guideline studies on the commercial complex of aromatic mixtures are highly relevant to assessing the toxicology of TMBs. EPA's Office of Pesticide Programs (OPP) has also reviewed the toxicology of TMBs and determined that the health effects of TMBs can be efficiently assessed by relying on C9 aromatic 14 Page Source: https://www.industrydocuments.ucsf.edu/docs/zlcn0226 mixture studies. OPP reached different scientific conclusions, including different quantitative health effect numbers, than that of EPA's IRIS Program. EPA, however, did not resolve these differences during the IRIS assessment of TMBs. c. Case 3: NIOSH Cancer Policy Background In the NIOSH Carcinogen Policy, released in December 2016, NIOSH states that underlying this entire policy is the "recognition that there is no known safe level of exposure to a carcinogen."39 ACC believes this statement is based on a default assumption and not clear scientific evidence, as certain carcinogens have thresholds or doses below which no adverse effects are identified. 40,41 Assuming that every chemical is toxic at high exposures and linear at low exposures does not comport with modern-day scientific knowledge of biology and there is no compelling evidence-based justification for a general low-exposure linearity. Instead, case- specific mechanistic arguments are needed. 42 d. Case 4: EPA IRIS Assessment of Ethylene Oxide (EO) Background EPA posted the final IRIS Assessment of EO in December 2016. EPA, using unsupportable, conservative, risk assessment modeling, concluded that the one-in-a-million lifetime cancer risk associated with exposure to EO is far below EO background levels currently in the environment and EO levels naturally converted from ethylene in humans through breathing. This conclusion is not plausible, and not scientifically supportable. It is based on an inadequate evaluation of a body of evidence from human studies that include historical exposure levels to 39 See NIOSH Carcinogen Policy available at: https://www.cdc.gov/niosh/docs/2017-100/default.html 40 See, for example Olden K, Vulimiri SV. 2014. Laboratory to community: chemoprevention is the answer. Cancer Prev Res (Phila). (7):648-52. http://cancerpreventionresearch.aacrjournals.org/content/canprevres/7/7/648.full.pdf at 650; which states: "Our understanding of toxicologic mechanisms has advanced considerably since the linear non- threshold model was adapted for cancer risk assessment. Knowledge of mechanism of action is critical for informing dose-response relationship below the experimental observable range. Johnson and colleagues (1) have used new technologies in analytical chemistry and molecular biology to characterize downstream biologic events in the exposure disease continuum. They showed that AFB1 is a classic genotoxic substance in that it binds covalently to DNA and induces mutations. In fact, DNA adduct formation exhibits a characteristic linear dose-response curve over a wide range. But, further analysis demonstrated a threshold mode of action, with respect to internal dose of active metabolite and hepatocarcinogenesis. That is, there was substantial adduct formation and DNA damage without having any affect [sic] on development of hepatocellular carcinoma." 41 See, for example: United States Environmental Protection Agency (EPA). 2015. Chemicals evaluated for carcinogenic potential office of pesticide programs, annual cancer report. Washington, DC. http://npic.orst.edu/chemicals evaluated.po EPA has determined that a number of substances that produce cancer at high doses are not likely to be carcinogenic to humans at low doses. 42 Rhomberg LR, Goodman JE, Haber LT, Dourson M, Andersen ME, Klaunig JE, Meek B, Price PS, McClellan RO, Cohen SM. 2011. Linear low-dose extrapolation for noncancer health effects is the exception, not the rule. Crit Rev Toxicol. 41(1):1-19.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3038594/pdf/btxc12-001.pdf and Bogen, KT. 2016. Linear-No-Threshold Default Assumptions for Noncancer and Nongenotoxic Cancer Risks: A Mathematical and Biological Critique. Risk Analysis Risk Analysis, Vol. 36, No. 3. ttp://onlinelibrary.wiley.com/doi/10.1111/risa.12460/pdf.. 15 Page Source: :ttps://www.industrydocuments.ucsf.edu/docs/zlcn0226 EO that are far higher than current occupational exposure limits. Other, more accurate, data sources are available, and alternative scientific risk assessment modeling approaches could have been used, but EPA made no serious, systematic attempt to integrate all of the evidence. Importance A determination by EPA that EO, with a myriad of important applications including the sterilization of medical equipment for surgery, can cause cancer at less than one part-per- trillion43 exposure will needlessly cause alarm and confusion, not only among workers, but also in the general population and in the public health and medical communities. These numbers are not reliably measurable, and are orders of magnitude below current endogenous and exogenous levels of EO. Scientific Concerns EPA did not adequately consider study quality into the IRIS review. Industry cohorts were not considered with the other epidemiology data sets even though this cohort was stronger than foreign cohorts used that contained occupational exposure interferences. EPA did not fully utilize linear and non-linear modeling approaches (as allowed within the cancer assessment guidance) to estimate cancer risk from current EO exposure levels and expected DNA repair mechanisms. EPA did not consider realistic exposure scenarios and fully delineate endogenous vs. exogenous EO and associated health impacts. In 2007, EPA's SAB identified problems with the linear regression modeling and low dose extrapolation for determining cancer risk. The SAB concluded that substantial revisions were needed in the IRIS assessment including: Acquiring and using individual data for modeling rather than grouping populations for modeling that currently results in overly conservative estimated cancer risks; Given the distribution of and questionable association with certain cancer types, considering using both linear and non-linear approaches to estimate cancer risk; Providing more transparency and correcting flaws associated with inappropriately grouping lymphohematopoietic (LH) cancers and combining genders for the dose- response analysis. In 2015, a specially selected SAB Committee reviewed a revised draft EO IRIS assessment. The committee, however, did not conduct an independent, unbiased review. Problems included: Inaccurate public statements by several SAB members indicating industry produced scientific studies should be disqualified due to potential industry influence, and the acceptance by SAB and IRIS staff of such a position; no evidence of biased data sponsored by industry was ever presented, and it is clear that those members advocating this position should have been disqualified due to these clear biased positions. 43 1 part per trillion is roughly equivalent to 1 second in 320 centuries or 1 inch in 16,000,000 miles 16 I Page Source: https://www.industrydocuments.ucsf.edu/docs/zlcn0226 Lack of understanding by SAB members of new evidence-based medicine concepts regarding mutagenicity of cancer cells and the contribution of naturally occurring EO in DNA repair mechanisms; Recommendation of epidemiology data sets with questionable or scientifically unsound characteristics to estimate cancer risk and rejection of alternative data sets that are as or more robust than those selected; EPA still did not use individual data for modeling as recommended in 2007, and did not seriously explore alternatives to the linear low dose modeling approach. Even though the SAB made extensive recommendations in its 2015 report and public comments were submitted on the IRIS draft reviewed by the SAB, EPA still did not respond fully to all comments submitted or implement all the changes recommended by the SAB. e. Case 5: National Ambient Air Quality Standard for Ground-Level Ozone Background In 2015, EPA lowered the National Ambient Air Quality Standard (NAAQS) for Ground-Level Ozone from 75 ppb to 70 ppb. Ozone, which is one of six criteria pollutants regulated under Section 109 of the Clean Air Act, is formed from a reaction between nitrogen oxide (NOx), volatile organic compounds (VOCs), and sunlight. Exposure to relatively high concentrations of ozone can cause adverse respiratory effects and interfere with plants' ability to produce and store food. In 2008, the ozone NAAQS was set at 75 ppb. Areas were not designated as complying or failing to comply with this standard until May 2012 due to unnecessary delays following the Obama Administration's premature reconsideration of the standard in 2010. This resulted in areas across the country not being allowed sufficient time to begin implementing the 2008 standard before EPA changed the standard again, which the Agency justified as being necessary to protect public health and welfare. However, a closer look at EPA's work during this most recent review process questions the need to revise down the standard. Scientific Concerns EPA relied on ecological epidemiology studies, also known as time-series analyses and clinical studies, as the basis to lower the ozone NAAQS to 70 ppb in 2015. However, EPA failed to adequately characterize the uncertainties associated with adverse health effects reported in these studies. Ecological epidemiology studies are not scientifically rigorous enough and are not designed to determine if ozone was responsible for the demonstrated the health effects. Clinical studies are limited by the small sample sizes and because they do not adequately consider the normal variation in the lung function. For example, in the 2015 standard, EPA relied on two new studies, Schelegle et al. (2009) 44 and Kim et al. (2011). 45 These studies both used a small sample which, while not unusual for a 44 Schelegle, ES; Morales, CA; Walby, WF; Marion, S; Allen, RP. 2009. 6.6-Hour inhalation of ozone concentrations from 60 to 87 parts per billion in healthy humans. Am. J. Respir. Crit. Care Med. 180(3):265-272. 45 Kim, CS; Alexis, NE; Rappold, AG; Kehrl, H; Hazucha, MJ; Lay, JC; Schmitt, MT; Case, M; Devlin, RB; Peden, DB; Diaz-Sanchez, D. 2011. Lung function and inflammatory responses in healthy young adults exposed to 0.06 ppm ozone for 6.6 hours. Am. J. Respir. Crit. Care Med. 183:1215-1221. 17 Page Source: https://www.industrydocuments.ucsf.edu/docs/zlcn0226 controlled human exposure study, proves difficult as a basis for drawing broader conclusions with regard to the protection of public health. EPA identified lung function decrements of only 2.8% to be adverse effects when the variation of lung function in normal subjects can vary by over 5% (Pellegrino et al. 2005)46 to 17.6% (Medarov et al. 2008.47 EPA must rely on biological, not just statistical, significance in identifying an adverse health and provide clear guidance on how to define adverse effects. Ultimately, these studies did not actually support health effects below the 75 ppb standard, and EPA primarily justified the regulation impacting 300 million people on study results from just a few individuals. 46 Pelligrino, R; Viegi, G; Brusasco, V; Crapo, RO; Burgos, F; Casaburi, R; Coates, A; van der Grinten, CPM; Gustafsson, P; Hankinson, J; Jensen, R; Johnson, DC; MacIntyre, N; McKay, R; Miller, MR; Navajas, D; Pedersen, OF; Wanger, J. 2005. Interpretive strategies for lung function tests. Eur. Respir J. 26: 948-968. 47 Medarov BI, Pavlov VA, Rossoff L. 2008. Diurnal variations in human pulmonary function. Int J Clin Exp Med. 1 (3) :267-273. 18 Page Source: :ttps://www.industrydocuments.ucsf.edu/docs/zlcn0226

Who is the author of the blog page?

gzbn0226

gzbn0226_p0, gzbn0226_p1, gzbn0226_p2, gzbn0226_p3, gzbn0226_p4, gzbn0226_p5, gzbn0226_p6

NANCY BECK, PH.D., D.A.B.T.

American Chemistry Council AMERICAN CHEMISTRY MATTERS A Blog of the American Chemistry Council Driving Innovation. Creating Johs and Enhancing Safety Matters Bements Contributars Archives Contact About Take Action ACC Newsroom Members in f a About Nancy Beck, Ph.D., D.A.B.T. Senior Director, Regulatory Science Policy I American Chemistry Council On the road with #ACCaugust - -2015 Chemicals in food: Top chemical food myths debunked. naturally) (video) Nanotechnology could be the next big thing Author Archive: Nancy Beck, Ph.D., D.A.B.T. in medical care Fueling Export Growth (Part 2 of 2): Why Carcinogen or not a carcinogen? A tale of two WHO the expected surge in U.S. chemicals exports will depend on our country' S ability Agencies, and the importance of evaluating study to deliver on its ambitious trade agenda quality and human relevance Fueling Export Growth (Part 1 of 2): U.S chemical exports linked to natural could by Nandy Geok Ph. & D.A.B.I. or 2016 in FOLIOY double by 2030; plastics products leading the surge How is il possible that two World Health Organization (WHO) agencies could evaluate the same chemical's potential to cause cancer and come to seemingly opposite conclusions? Dr. David Gastmond explored this question in a presentation at the Summer Toxicology Forum meeting comparing the approaches taken by the International Agency for Research on Cancer (IARC) and (...) RSS SUBSCRIPTION READ FULL STORY WELCOME TO THE BLOG OF THE AMERICAN CHEMISTRY COUNCIL The pursuit of quality in risk assessment Search Q by Nancy Geok. 26.0 DABT on SEFTOVEER 16, 2016 :83 ECLICY The Toxicology Forum is an international organization that encourages dialogue among government agencies, industry, academia, policymakers, and NGOs concerned with public health issues. Following Congress's TOP recent passage of the Lautenberg Chemical Safety Act, the Toxicology Forum's summer meeting in Salt Lake The Washinaton post City, featured a particularly interesting and timely session on "the pursuit of quality and 1..] - READ FULL STORY Facebook What a "defective" radiation-risk standard can teach US Tweets by @AmChemistry Source: https://www.industrydocuments.ucsf.edu/docs/gzbn0226 about improving chemical risk assessments by Beck on 28. 2016 in POUCY Wall Street Journal editorial board member Holman W. Jenkins, Jr. seems to have a knack for battling bad science which especially what he perceives to be misguided reporting and alarmist stories about climate change. in his most recent piece, Jenkins laments the fact that some activisis have used faulty research to overstate the risks associated [...] READ FULL STORY Fixing EPA's chemical assessment program - Latest reviews show IFIS is still a work in progress by Nanoy Beok Eb.D. DABT on FEERUARY 22, 2016 in INDUSTEY It's hard to believe but this year marks the filth anniversary of the National Academy of Sciences' (NAS) 2011 report on the Environmental Protection Agency's (EPA) integrated Risk information System (IRIS) program. The report identified systemic problems and offered sweeping recommendations to overhaul the program. So what has happened in the five years since the [...] READ FULL STORY Grappling with uncertainty: New paper offers D. a better approach by Beok. DABIT or FEBRUARY 16. 2016 in INDUSTEY As Donald Rumsfeld taught us, how you handle and communicate what you don't know is just as important as dealing with what you do know. A new paper recently published by the scientific journal Environment International offers several different ways to help better address the uncertainty conundrum when it comes to sharing the results of [...] READ FULL STORY Had we been given the opportunity, here's what we would have offered the NIEHS on its new NTP PloC Handbook by Nancy, Beck of DABT. on SEPTEMBER 28. 2015 in INDUSTRY One way in which the National institute of Environmental Health Sciences (NIEHS) National Toxicology Program (NTP) could demonstrate its commitment to transparency is by seeking public comment on its guidance documents prior to finalizing and implementing them. Not only would this help NTP to develop a robust approach, but it would also allow outside experts, (... READ FULL STORY IFIS progress report details key improvements, but the Source: https://www.industrydocuments.ucsf.edu/docs/gzbn0226 bar must be raised higher by Nancy Back. Ph. on MAY 13. 2018 in According to a May 2015 progress report to Congress, the Environmental Protection Agency's (EPA) Integrated Risk Information System (IRIS) is better off than it was a year ago, but not as effective as it needs to be to deliver timely, high-quality and credible chemical risk assessments. EPA does deserve credit, first and foremost, for following (...) READ FULL STORY Returning to fundamental principles can help science live up to the public trust by Nancy Back. Eb.D. D.A.S.T. on NOVEMEER24 2014 in POLICY A revised approach in the biomedical sciences for reporting research should set a strong precedent for researchers, publishers, and regulators around the U.S. who are committed to improving the science that guides public health decisions, Scientists today are more prolific than ever. The sheer body of research published every year can be overwheiming-trom breakthroughs in .... READ FULL STORY Two keys to a stronger chemical assessment program: Planning for success and avoiding pitfalls by Nancy. Beck. Ph D. D.A.S.T. on OCTOBER 14. 2014 in INDUSTEY This week's Integrated Risk information System (IRIS) workshop on the National Research Council's (NRC) recommendations for improving federal chemical assessments gives the U.S. Environmental Protection Agency (EPA) an opportunily to build on the progress it has already made in creating a sound, more transparent, and objective assessment program. While the agenda for the workshop covers READ FULL STORY What are the key challenges for improving risk sessments? Two experts weigh in by Nancy Beak. Ph.D. on MAYA, 2014 in POLICY Two recurring themes at the 53rd meeting of the Society of Toxicology (SOT) in Phoenix, Arizona, were enhancing strategies for risk assessment and finding new ways to conduct safety assessments. Here are three questions (and some potential answers) that continue to drive the debate. What are the biggest issues for the future of risk assessment? READ FULL STORY / a Next BLOGROLL TRENDING ELEMENTS Source: https://www.industrydocuments.ucsf.edu/docs/gzbn0226 ACC's Principles for Improving Chemical Hazard and Risk Assessments Assessments should focus on understanding the inherent properties of substances in order to determine the likelihood of harm from a specific exposure. The public, businesses and regulators look to government Design assessments for reliable information about the potential hazards and risks associated with chemicals. Identify Key Science Issues Use Modern Science and Tools Prior to Initiation of Assessment Use relevant data Discuss the purpose, scope and technical approaches Consider how chemicals act in the body I Engage stakeholders Evaluate chemicals at relevant exposure levels Data and Methods Apply Objective Criteria Integrate Evidence Develop and apply consistent criteria for selecting Give the greatest weight to information from the and evaluating a study, before an assessment begins highest-quality and most-relevant studies Evaluate all studies to determine their quality, Transparently and objectively integrate evidence relevance and reliability to make realistic determinations of hazards and risks; consider all types of evidence Ensure Assessments Characterize Hazards and are Transparent Risks Fully and Accurately Communication Disclose key information and assumptions used Present hazards and risks in an easy-to- understand to develop assessments and reach conclusions manner to stakeholders and risk managers Make materials, including important data sets, Present a range of plausible values, including publicly available central estimates when going beyond a screening level assessment Conduct Scientific Peer Review by Improve Accountability O Independent Experts Use an independent accountability procedure to Ensure peer reviewers are fully independent from the verify that revised assessments are accurate program office issuing the assessment and responsive to scientific and peer review Review and Evaluate peer review panels for conflicts of interest; ensure panels contain a balance of perspectives and appropriate technical expertise RESULT. Public Trust in High-Quality Risk Assessment Source: https://www.industrydocuments.ucsf.edu/docs/gzbn0226 Formaldehyde Assessments Must Properly Evaluate and Integrate All Available Evidence Data and A fully integrated chemical assessment requires that all available scientific Methods evidence is evaluated for quality and relevance, then analyzed together to make an informed decision. Mechanistic Data WHAT THE is Animal Data SCIENCE TELLS US: (Studies about what a chemical does (Experimental data from in the human body and how it does it) animal lab studies) When integrating the three Compelling evidence shows that types of evidence, it is clear The best-available studies show inhaled formaldehyde does not that the data do not support a that inhaled formaldehyde has no reach bone marrow (Swenberg relationship between inhaled effect on blood or bone marrow. et al. 2011). formaldehyde and leukemia A recent NTP study on two There are no reliable, in humans. strains of mice genetically high-quality mechanistic data predisposed to develop leukemia available to support speculation to high doses of inhaled that formaldehyde causes formaldehyde and confirmed no leukemia. leukemia effects. Epidemiological Data (Studies of select human populations) Extensive and detailed critical reviews of epidemiological literature do not support a causal relationship between formaldehyde exposure and leukemia. When data from three large, high-quality studies are combined, the number of leukemia cases in the studied occupationally-exposed populations is essentially the same as what is expected in the U.S. population (152 v. 153), indicating there is no appreciable risk for developing leukemia. Source: https://www.industrydocuments.ucsf.edu/docs/gzbn0226 American Chemistry Council AMERICAN CHEMISTRY MATTERS A Blog of the American Chemistry Council Driving Innovation, Creating Jobs and Enhancing Safety Matters Elements Contributors Archives Contact About Take Action ACC Newsroom Members f n Returning to fundamental principles can help science LATEST TAGS live up to the public trust On the road with #ACCaugust 3.0 by Nancy Beck. Ph D. D.A.B.T. on NOVEMBER 24. 2014 in POUSY AUGUST 25, 2017 f Facebook Chemical industry prepared for new storm Linkedin 2 heading to U.S. guli coast AUGUST 24, 2017 Issues around listing chemicals under Prop A revised approach in the biomedical sciences for reporting research should set a strong precedent for 65 researchers, publishers, and regulators around the U.S. who are committed to improving the science that AUGUST 8, 2017 guides public health decisions. Scientists today are more prolific than ever. The sheer body of research published every year can be breakthroughs in innovation, to new health and safety studies, to novel solutions to improve environmental health. If there is one thing that should ground them all in the public trust, it should be a commitment to adhering to an established sound scientific process. Search Q Unfortunately, many of the scientific studies we read about in the news were not quite ready for prime time. Forbes contributor Geoffrey Kabat wrote in a November 15 piece that often il is the "anomalous, and almost certainly wrong, results" that can get the most attention. As Kabat points out, these inconsistent results can PREVIOUS POSTS have serious ramifications for public health: Previous Posts Select Month 66 This phenomenon leads to an enormous waste of resources, which comes at the expense of research that might actually lead to saving lives. it also confisses the public and leads people to mistrust science generally. Many in the scientific community agree, and at least one group of editors has already begun to lead a return to the fundamental principles of science to restore public confidence. Journals stand up for science "Reproducibility, rigor, transparency, and independent verification are comerstones of the scientific method," Editor-in-Chief Marcia McNutt made clear at the opening of a November 7 editorial published in the journal Science. According to McNutt, a swath of aditors from more than 30 major journals, together with funding agencies and other scientific leaders met at the American Association for the Advancement of Science headquarters sartier this year to tackie the reproducibility issue plaguing so many prectinical studies of late. Below is a list of guidelines they agreed to as first big step toward improving the integrity of the biomedical sciences: Journais should make il clear to authors the policies for statistical analysis and how they review the statistical accuracy of work under consideration Source: https://www.industrydocuments.ucsf.edu/docs/gzbn0226 Any imposed page limits should not discourage reproducibility (in other words, researchers should be given the time and space to show their work) Researchers should use a checklist to ensure the reporting of important experimental parameters: standards used, number and type of replicates, statistics, method of randomization, whether experimenters were blind to the conduct of the experiment, how the sample size was determined, and what criteria were used to include or exclude any data Journals should recommend that data be placed in public repositories, where available, and linked to the paper to ensure proper attribution Journals should ensure that all datasets relied upon for conclusions in the paper are made available upon request, where ethically appropriate, by editors and reviewers; in addition, journals should encourage the release of data for sharing after publication Once a journal publishes a paper, it should assume the obligation to consider publication of a refutation of that paper, subject to its usual standards of quality Journals should consider establishing best practices guidelines for images and biological material use. Valuable tessons for Improving chemical assessments Because of their fundamental nature, the guidelines have tremendous potential to help the public beyond their use by journals and beyond the biomedical science field. For example, many of the guidelines proposed in McNutt's editorial are consistent with the recommendations that have been recently offered to improve how federal programs are evaluating chemicals. For example, there are many parallels when it comes to improving the review and transparency of the research used in chemical assessment programs. in several cases, these concepts are in line with ACC's principles for enhancing federal risk assessment, especially when it comes to evaluating data and selecting studies used in assessments and providing full disclosure of underlying data and key information used to develop assessments. Fully implementing these improvements to chemical assessments will provide regulators, the public, and industry with more accurate and useful information to help guide better decisions for protecting human health and the environment. Call to action Now that leaders in the biomedical sciences have acknowledged that their journals may not always meet scientific standards of reproducibility, rigor, transparency and independent verification, it's time that researchers and journals that examine chemicals do the same. The American Association for the Advancement of Science (AAAS) pledge should serve as a wake-up call to researchers and journals across the toxicological sciences to step up their game by renewing their commitment to the scientific method. And regulators can help facilitate this "return to the science" by rigorously reviewing existing published studies to ensure they meet these core tenels of the scientific method and calling on journals to publish more robust, independently verified studies going forward, As McNutt concludes, "The hope is that these guidelines will not be viewed as onerous, but as part of the quality control that justifies the public trust in science." S Facebook Linkedin American Association for the Adyanosment of Sciance. Chamical Assessment, Kabat, Marcia McNutt. Risk. Safety NANOSAFE 2014 conference in France features paper aconsored by ACC's Panal Versatile, Durable. incendible Macy's Thankegiving Day Parade Balloons! Source: https://www.industrydocuments.ucsf.edu/docs/gzbn0226

Where was the Toxicology Forum's summer meeting held?

gzbn0226

gzbn0226_p0, gzbn0226_p1, gzbn0226_p2, gzbn0226_p3, gzbn0226_p4, gzbn0226_p5, gzbn0226_p6

SALT LAKE CITY, Salt Lake City.

American Chemistry Council AMERICAN CHEMISTRY MATTERS A Blog of the American Chemistry Council Driving Innovation. Creating Johs and Enhancing Safety Matters Bements Contributars Archives Contact About Take Action ACC Newsroom Members in f a About Nancy Beck, Ph.D., D.A.B.T. Senior Director, Regulatory Science Policy I American Chemistry Council On the road with #ACCaugust - -2015 Chemicals in food: Top chemical food myths debunked. naturally) (video) Nanotechnology could be the next big thing Author Archive: Nancy Beck, Ph.D., D.A.B.T. in medical care Fueling Export Growth (Part 2 of 2): Why Carcinogen or not a carcinogen? A tale of two WHO the expected surge in U.S. chemicals exports will depend on our country' S ability Agencies, and the importance of evaluating study to deliver on its ambitious trade agenda quality and human relevance Fueling Export Growth (Part 1 of 2): U.S chemical exports linked to natural could by Nandy Geok Ph. & D.A.B.I. or 2016 in FOLIOY double by 2030; plastics products leading the surge How is il possible that two World Health Organization (WHO) agencies could evaluate the same chemical's potential to cause cancer and come to seemingly opposite conclusions? Dr. David Gastmond explored this question in a presentation at the Summer Toxicology Forum meeting comparing the approaches taken by the International Agency for Research on Cancer (IARC) and (...) RSS SUBSCRIPTION READ FULL STORY WELCOME TO THE BLOG OF THE AMERICAN CHEMISTRY COUNCIL The pursuit of quality in risk assessment Search Q by Nancy Geok. 26.0 DABT on SEFTOVEER 16, 2016 :83 ECLICY The Toxicology Forum is an international organization that encourages dialogue among government agencies, industry, academia, policymakers, and NGOs concerned with public health issues. Following Congress's TOP recent passage of the Lautenberg Chemical Safety Act, the Toxicology Forum's summer meeting in Salt Lake The Washinaton post City, featured a particularly interesting and timely session on "the pursuit of quality and 1..] - READ FULL STORY Facebook What a "defective" radiation-risk standard can teach US Tweets by @AmChemistry Source: https://www.industrydocuments.ucsf.edu/docs/gzbn0226 about improving chemical risk assessments by Beck on 28. 2016 in POUCY Wall Street Journal editorial board member Holman W. Jenkins, Jr. seems to have a knack for battling bad science which especially what he perceives to be misguided reporting and alarmist stories about climate change. in his most recent piece, Jenkins laments the fact that some activisis have used faulty research to overstate the risks associated [...] READ FULL STORY Fixing EPA's chemical assessment program - Latest reviews show IFIS is still a work in progress by Nanoy Beok Eb.D. DABT on FEERUARY 22, 2016 in INDUSTEY It's hard to believe but this year marks the filth anniversary of the National Academy of Sciences' (NAS) 2011 report on the Environmental Protection Agency's (EPA) integrated Risk information System (IRIS) program. The report identified systemic problems and offered sweeping recommendations to overhaul the program. So what has happened in the five years since the [...] READ FULL STORY Grappling with uncertainty: New paper offers D. a better approach by Beok. DABIT or FEBRUARY 16. 2016 in INDUSTEY As Donald Rumsfeld taught us, how you handle and communicate what you don't know is just as important as dealing with what you do know. A new paper recently published by the scientific journal Environment International offers several different ways to help better address the uncertainty conundrum when it comes to sharing the results of [...] READ FULL STORY Had we been given the opportunity, here's what we would have offered the NIEHS on its new NTP PloC Handbook by Nancy, Beck of DABT. on SEPTEMBER 28. 2015 in INDUSTRY One way in which the National institute of Environmental Health Sciences (NIEHS) National Toxicology Program (NTP) could demonstrate its commitment to transparency is by seeking public comment on its guidance documents prior to finalizing and implementing them. Not only would this help NTP to develop a robust approach, but it would also allow outside experts, (... READ FULL STORY IFIS progress report details key improvements, but the Source: https://www.industrydocuments.ucsf.edu/docs/gzbn0226 bar must be raised higher by Nancy Back. Ph. on MAY 13. 2018 in According to a May 2015 progress report to Congress, the Environmental Protection Agency's (EPA) Integrated Risk Information System (IRIS) is better off than it was a year ago, but not as effective as it needs to be to deliver timely, high-quality and credible chemical risk assessments. EPA does deserve credit, first and foremost, for following (...) READ FULL STORY Returning to fundamental principles can help science live up to the public trust by Nancy Back. Eb.D. D.A.S.T. on NOVEMEER24 2014 in POLICY A revised approach in the biomedical sciences for reporting research should set a strong precedent for researchers, publishers, and regulators around the U.S. who are committed to improving the science that guides public health decisions, Scientists today are more prolific than ever. The sheer body of research published every year can be overwheiming-trom breakthroughs in .... READ FULL STORY Two keys to a stronger chemical assessment program: Planning for success and avoiding pitfalls by Nancy. Beck. Ph D. D.A.S.T. on OCTOBER 14. 2014 in INDUSTEY This week's Integrated Risk information System (IRIS) workshop on the National Research Council's (NRC) recommendations for improving federal chemical assessments gives the U.S. Environmental Protection Agency (EPA) an opportunily to build on the progress it has already made in creating a sound, more transparent, and objective assessment program. While the agenda for the workshop covers READ FULL STORY What are the key challenges for improving risk sessments? Two experts weigh in by Nancy Beak. Ph.D. on MAYA, 2014 in POLICY Two recurring themes at the 53rd meeting of the Society of Toxicology (SOT) in Phoenix, Arizona, were enhancing strategies for risk assessment and finding new ways to conduct safety assessments. Here are three questions (and some potential answers) that continue to drive the debate. What are the biggest issues for the future of risk assessment? READ FULL STORY / a Next BLOGROLL TRENDING ELEMENTS Source: https://www.industrydocuments.ucsf.edu/docs/gzbn0226 ACC's Principles for Improving Chemical Hazard and Risk Assessments Assessments should focus on understanding the inherent properties of substances in order to determine the likelihood of harm from a specific exposure. The public, businesses and regulators look to government Design assessments for reliable information about the potential hazards and risks associated with chemicals. Identify Key Science Issues Use Modern Science and Tools Prior to Initiation of Assessment Use relevant data Discuss the purpose, scope and technical approaches Consider how chemicals act in the body I Engage stakeholders Evaluate chemicals at relevant exposure levels Data and Methods Apply Objective Criteria Integrate Evidence Develop and apply consistent criteria for selecting Give the greatest weight to information from the and evaluating a study, before an assessment begins highest-quality and most-relevant studies Evaluate all studies to determine their quality, Transparently and objectively integrate evidence relevance and reliability to make realistic determinations of hazards and risks; consider all types of evidence Ensure Assessments Characterize Hazards and are Transparent Risks Fully and Accurately Communication Disclose key information and assumptions used Present hazards and risks in an easy-to- understand to develop assessments and reach conclusions manner to stakeholders and risk managers Make materials, including important data sets, Present a range of plausible values, including publicly available central estimates when going beyond a screening level assessment Conduct Scientific Peer Review by Improve Accountability O Independent Experts Use an independent accountability procedure to Ensure peer reviewers are fully independent from the verify that revised assessments are accurate program office issuing the assessment and responsive to scientific and peer review Review and Evaluate peer review panels for conflicts of interest; ensure panels contain a balance of perspectives and appropriate technical expertise RESULT. Public Trust in High-Quality Risk Assessment Source: https://www.industrydocuments.ucsf.edu/docs/gzbn0226 Formaldehyde Assessments Must Properly Evaluate and Integrate All Available Evidence Data and A fully integrated chemical assessment requires that all available scientific Methods evidence is evaluated for quality and relevance, then analyzed together to make an informed decision. Mechanistic Data WHAT THE is Animal Data SCIENCE TELLS US: (Studies about what a chemical does (Experimental data from in the human body and how it does it) animal lab studies) When integrating the three Compelling evidence shows that types of evidence, it is clear The best-available studies show inhaled formaldehyde does not that the data do not support a that inhaled formaldehyde has no reach bone marrow (Swenberg relationship between inhaled effect on blood or bone marrow. et al. 2011). formaldehyde and leukemia A recent NTP study on two There are no reliable, in humans. strains of mice genetically high-quality mechanistic data predisposed to develop leukemia available to support speculation to high doses of inhaled that formaldehyde causes formaldehyde and confirmed no leukemia. leukemia effects. Epidemiological Data (Studies of select human populations) Extensive and detailed critical reviews of epidemiological literature do not support a causal relationship between formaldehyde exposure and leukemia. When data from three large, high-quality studies are combined, the number of leukemia cases in the studied occupationally-exposed populations is essentially the same as what is expected in the U.S. population (152 v. 153), indicating there is no appreciable risk for developing leukemia. Source: https://www.industrydocuments.ucsf.edu/docs/gzbn0226 American Chemistry Council AMERICAN CHEMISTRY MATTERS A Blog of the American Chemistry Council Driving Innovation, Creating Jobs and Enhancing Safety Matters Elements Contributors Archives Contact About Take Action ACC Newsroom Members f n Returning to fundamental principles can help science LATEST TAGS live up to the public trust On the road with #ACCaugust 3.0 by Nancy Beck. Ph D. D.A.B.T. on NOVEMBER 24. 2014 in POUSY AUGUST 25, 2017 f Facebook Chemical industry prepared for new storm Linkedin 2 heading to U.S. guli coast AUGUST 24, 2017 Issues around listing chemicals under Prop A revised approach in the biomedical sciences for reporting research should set a strong precedent for 65 researchers, publishers, and regulators around the U.S. who are committed to improving the science that AUGUST 8, 2017 guides public health decisions. Scientists today are more prolific than ever. The sheer body of research published every year can be breakthroughs in innovation, to new health and safety studies, to novel solutions to improve environmental health. If there is one thing that should ground them all in the public trust, it should be a commitment to adhering to an established sound scientific process. Search Q Unfortunately, many of the scientific studies we read about in the news were not quite ready for prime time. Forbes contributor Geoffrey Kabat wrote in a November 15 piece that often il is the "anomalous, and almost certainly wrong, results" that can get the most attention. As Kabat points out, these inconsistent results can PREVIOUS POSTS have serious ramifications for public health: Previous Posts Select Month 66 This phenomenon leads to an enormous waste of resources, which comes at the expense of research that might actually lead to saving lives. it also confisses the public and leads people to mistrust science generally. Many in the scientific community agree, and at least one group of editors has already begun to lead a return to the fundamental principles of science to restore public confidence. Journals stand up for science "Reproducibility, rigor, transparency, and independent verification are comerstones of the scientific method," Editor-in-Chief Marcia McNutt made clear at the opening of a November 7 editorial published in the journal Science. According to McNutt, a swath of aditors from more than 30 major journals, together with funding agencies and other scientific leaders met at the American Association for the Advancement of Science headquarters sartier this year to tackie the reproducibility issue plaguing so many prectinical studies of late. Below is a list of guidelines they agreed to as first big step toward improving the integrity of the biomedical sciences: Journais should make il clear to authors the policies for statistical analysis and how they review the statistical accuracy of work under consideration Source: https://www.industrydocuments.ucsf.edu/docs/gzbn0226 Any imposed page limits should not discourage reproducibility (in other words, researchers should be given the time and space to show their work) Researchers should use a checklist to ensure the reporting of important experimental parameters: standards used, number and type of replicates, statistics, method of randomization, whether experimenters were blind to the conduct of the experiment, how the sample size was determined, and what criteria were used to include or exclude any data Journals should recommend that data be placed in public repositories, where available, and linked to the paper to ensure proper attribution Journals should ensure that all datasets relied upon for conclusions in the paper are made available upon request, where ethically appropriate, by editors and reviewers; in addition, journals should encourage the release of data for sharing after publication Once a journal publishes a paper, it should assume the obligation to consider publication of a refutation of that paper, subject to its usual standards of quality Journals should consider establishing best practices guidelines for images and biological material use. Valuable tessons for Improving chemical assessments Because of their fundamental nature, the guidelines have tremendous potential to help the public beyond their use by journals and beyond the biomedical science field. For example, many of the guidelines proposed in McNutt's editorial are consistent with the recommendations that have been recently offered to improve how federal programs are evaluating chemicals. For example, there are many parallels when it comes to improving the review and transparency of the research used in chemical assessment programs. in several cases, these concepts are in line with ACC's principles for enhancing federal risk assessment, especially when it comes to evaluating data and selecting studies used in assessments and providing full disclosure of underlying data and key information used to develop assessments. Fully implementing these improvements to chemical assessments will provide regulators, the public, and industry with more accurate and useful information to help guide better decisions for protecting human health and the environment. Call to action Now that leaders in the biomedical sciences have acknowledged that their journals may not always meet scientific standards of reproducibility, rigor, transparency and independent verification, it's time that researchers and journals that examine chemicals do the same. The American Association for the Advancement of Science (AAAS) pledge should serve as a wake-up call to researchers and journals across the toxicological sciences to step up their game by renewing their commitment to the scientific method. And regulators can help facilitate this "return to the science" by rigorously reviewing existing published studies to ensure they meet these core tenels of the scientific method and calling on journals to publish more robust, independently verified studies going forward, As McNutt concludes, "The hope is that these guidelines will not be viewed as onerous, but as part of the quality control that justifies the public trust in science." S Facebook Linkedin American Association for the Adyanosment of Sciance. Chamical Assessment, Kabat, Marcia McNutt. Risk. Safety NANOSAFE 2014 conference in France features paper aconsored by ACC's Panal Versatile, Durable. incendible Macy's Thankegiving Day Parade Balloons! Source: https://www.industrydocuments.ucsf.edu/docs/gzbn0226

Which one is the first for profit sponsor listed?

lmcn0226

lmcn0226_p2, lmcn0226_p3

AMERICAN CHEMISTRY COUNCIL, American Chemistry Council

2015 TERA Project Time by Sponsor 6% Collaborators Coalition of Project Sponsors Alliance for Risk Assessment Beyond Science and Decisions: From Problem Formation to Dose Response Kids Chemical Safety Webpage For Profit 32% OARS: WEEL Project Sponsorsi American Chemistry Council Amgen Coca Cola Genentech GOJO Hamp, Mathews & Associates, Inc, Steptoe & Johnson 2% Education Training Projects 68% Government/Non-Profit Project Sponsors Dose-Response Boot Camp Consumer Product Safety Commission Health Canada International Life Sciences International Texas Commission on Environmental Quality The sponsors listed above are sponsors that each comprise 2% or more of our work. 25 12015 T E R A Annual Report Source: https://www.industrydocuments.ucsf.edu/docs//Imcn0226 2014 TERA Project Time by Sponsor 43% 2% For Profit Training Projects/Sponsors Projects/Sponsors + American Cleaning Institute + Dose Response Boot Camp + Amgen + FDA Training Course + Eli Lily + Genentech + Morrison & Foerster + Quinn 57% 9% Government/ Collaborations Nonprofit Projects/Sponsors Projects/Sponsors + Consumer Product Safety Commission + Alliance for Risk Assessment TCE Coaltion + ERM: Alaska Sulfolane + Beyond Science & Decisions + Health Canada + Kidschemicalsafety.org + West Virginia Spill - MCHM + Occupational Alliance for Risk Assessment Source: https://www.industrydocuments.ucsf.edu/docs/Imcn0226

Coca cola is under which category of sponsors?

lmcn0226

lmcn0226_p2, lmcn0226_p3

FOR PROFIT, For Profit

2015 TERA Project Time by Sponsor 6% Collaborators Coalition of Project Sponsors Alliance for Risk Assessment Beyond Science and Decisions: From Problem Formation to Dose Response Kids Chemical Safety Webpage For Profit 32% OARS: WEEL Project Sponsorsi American Chemistry Council Amgen Coca Cola Genentech GOJO Hamp, Mathews & Associates, Inc, Steptoe & Johnson 2% Education Training Projects 68% Government/Non-Profit Project Sponsors Dose-Response Boot Camp Consumer Product Safety Commission Health Canada International Life Sciences International Texas Commission on Environmental Quality The sponsors listed above are sponsors that each comprise 2% or more of our work. 25 12015 T E R A Annual Report Source: https://www.industrydocuments.ucsf.edu/docs//Imcn0226 2014 TERA Project Time by Sponsor 43% 2% For Profit Training Projects/Sponsors Projects/Sponsors + American Cleaning Institute + Dose Response Boot Camp + Amgen + FDA Training Course + Eli Lily + Genentech + Morrison & Foerster + Quinn 57% 9% Government/ Collaborations Nonprofit Projects/Sponsors Projects/Sponsors + Consumer Product Safety Commission + Alliance for Risk Assessment TCE Coaltion + ERM: Alaska Sulfolane + Beyond Science & Decisions + Health Canada + Kidschemicalsafety.org + West Virginia Spill - MCHM + Occupational Alliance for Risk Assessment Source: https://www.industrydocuments.ucsf.edu/docs/Imcn0226

Which councils name is mentioned at the top?

zlcn0226

zlcn0226_p0, zlcn0226_p1, zlcn0226_p2, zlcn0226_p3, zlcn0226_p4, zlcn0226_p5, zlcn0226_p6, zlcn0226_p7, zlcn0226_p8, zlcn0226_p9, zlcn0226_p10, zlcn0226_p11, zlcn0226_p12, zlcn0226_p13, zlcn0226_p14, zlcn0226_p15, zlcn0226_p16, zlcn0226_p17

American Chemistry Council

American' Chemistry Council Written Statement of Nancy B. Beck, Ph.D., DABT Senior Director of Regulatory & Technical Affairs American Chemistry Council Before the U.S. Senate Committee on Homeland Security and Governmental Affairs Subcommittee on Regulatory Affairs and Federal Management Regarding a Hearing on the Agency Use of Science in the Rulemaking Process: Proposals for Improving Transparency and Accountability March 9, 2017 American Chemistry Council 700 2nd Street, N.E. Washington, D.C. 20002 1 I Page Source: https://www.industrydocuments.ucsf.edu/docs/zlcn0226 Summary The American Chemistry Council (ACC¹ appreciates this opportunity to provide testimony on Federal Agency use of science in the rulemaking process, and particularly on proposals for improving transparency and accountability. The business of chemistry is a critical component for manufacturing safe, high quality products and ACC member companies rely on science to conduct the research necessary to discover new chemistries and identify new applications of existing chemistries. They also rely on science to develop new tools for assessing the potential hazards, exposures and risks of chemical substances. Similarly, they expect high quality, up to date science and relevant reliable assessment processes to underpin regulatory decisions by the Federal government. Reliance on the highest quality, best available science is critical to ensuring public trust. Without it, consumers are at a severe disadvantage. Stakeholders can lose confidence in regulatory decision making, which in turn can lead to product de-selection that is not supported by science, unwarranted public alarm and unnecessary costs. ACC supports actions to enhance the integration of the best available scientific knowledge and weight of the evidence methods as the foundation for regulatory decision making across Federal Agencies. We also support improving the technical quality and objectivity of Agency evaluations, particularly through enhancing the transparency of how the science is being considered, interpreted, and evaluated. In 2002, Federal Agencies were directed to ensure the quality, objectivity, utility and integrity of information which they disseminated to the public.² In theory, this should have had a direct impact on improving the quality of scientific analyses that support regulatory decisions. Unfortunately, while most Agencies have committed to meeting these standards, we have seen that some of the scientific analyses that have come out of the EPA and other Federal Agencies fall short of meeting the objectivity and quality standards discussed in the government-wide Information Quality Guidelines. 1 ACC represents the leading companies engaged in the business of chemistry. ACC members apply the science of chemistry to make innovative products and services that make people's lives better, healthier and safer. ACC is committed to improved environmental, health and safety performance through Responsible Care®, common sense advocacy designed to address major public policy issues, and health and environmental research and product testing. The business of chemistry is a $797 billion enterprise and a key element of the nation's economy. It is the nation's largest exporter, accounting for fourteen percent of all U.S. exports. It is also one of the nation's most heavily regulated industries. Chemistry companies are among the largest investors in research and development. 2 Pursuant to what is commonly referred to as the Information Quality Act (Sec. 515 of the Treasury and General Government Appropriations Act for FY 2001, Pub. L. No. 106-554), the Office of Management and Budget (OMB) issued government-wide Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies (2002), 67 Fed. Reg. 8452 (Feb. 22, 2002) [hereinafter Information Quality Guidelines], available at: https://georgewbush-whitehouse.archives.gov/omb/memoranda/fy2007/m07-24.pdf; 2 I Page Source: https://www.industrydocuments.ucsf.edu/docs/zlcn0226 ACC's testimony today discusses some of the standards that already exist, discusses the new Lautenberg Chemical Safety Act scientific standards, and provides some suggestions for ensuring the quality of science that supports regulatory activities. We also share examples of where some Agencies' scientific evaluations continue to fall short. I. The Need for Confidence in Science As we are all aware from the news media, there is a large public perception that science may not inform Federal Agency decision making. Indeed even organizations like the American Association for the Advancement of Science (AAAS) have now become official partners in the planned April 22, 2017 March for Science. Dr. Rush Holt, the CEO of AAAS has stated "We see the activities collectively known as the March as a unique opportunity to communicate the importance, value and beauty of science." Concerns about confidence in science, particularly to inform regulations, is not new and certainly did not begin with the 2016 elections. In 2013, George Mason University conducted a survey to help capture the viewpoints of the scientific community on the state of regulatory risk assessment. The survey "Expert Opinion on Regulatory Risk Assessment" reached out to all members of the Society of Toxicology Risk Assessment Specialty Section, the Society for Risk Analysis Dose Response Section and the International Society for Regulatory Toxicology and Pharmacology. 4 The survey focused on how well and how frequently critical parts of a risk evaluation were conducted (e.g., was there a problem formulation, were standardized protocols used for data collection, was a weight of evidence approach used, was peer review sufficient). In general, the findings showed that there is widespread concern over the current application of these procedures and also showed concerns about the amount of attention given to scientific factors in risk management.5 In July 2016, almost 200 toxicologists signed "an appeal for the integrity of science in public policy." This appeal urges legislators to embed the "rules of evidence" of the scientific method in statutes governing administrative policy and regulations. These scientists are concerned that precautionary regulations and policies are being presented as objective science, when in reality they are not. In another recent article, Dr. Andrew Rosenberg of the Union of Concerned Scientists stated, "When science is sidelined from policy decisions, we all lose."7 ACC shares the concerns and recommendations of this diverse set of scientists. Too often we see scientific assessments, or even policies, that are driven by default assumptions rather than actual scientific evidence. 8 ACC has consistently called upon the EPA to improve the design and conduct of its chemical assessments. In 2014, ACC released Principles for Improving Chemical Hazard and Risk 3 See Science Magazine, Feb 28, 2017 article available at: uttp:llwww.sciencemag.org/new/2017/02/will-they-or- won-t-theywhat-science-groups-are-saying-about-joining-march-science. 4 The Survey and results can be found at: https://cmpa.gmu.edu/wp-content/uploads/2013/12/GMU-Study Report.pdf. 5 Ibid at page 2. 6 See article available at: http://www.sciencedirect.com/science/article/pii/S0300483X16301123. 7 See Science Magazine, Feb 17, 2017 article available at: http://science.sciencemag.org/content/355/6326/696/tab pdf. 8 See NIOSH Carcinogen Policy example provided in Appendix 1 of this testimony. 3 a 8 Source: https://www.industrydocuments.ucsf.edu/docs/zlcn0226 Assessments.9 ACC did not invent these principles. For years, authoritative bodies, like the National Academy of Sciences (NAS), have provided similar constructive input to the EPA. 10 Appendix 1 of this testimony provides some specific examples of cases where Federal Agency evaluations have not met scientific standards. II. Tools and Standards Exist to Improve Agency Science Improving Federal Agency science should not be as challenging as it has been. Significant governmental and non-governmental guidance already exists. As noted below, often this guidance is not followed. a. Information Quality Guidelines In 2002, the Office of Management and Budget (OMB) released the Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies (Information Quality Guidelines). 11 The guidelines were then adopted by Federal Agencies and the OMB's principles were to be reflected in the agency-specific guidelines. With regard to the analysis of risks to human health, safety and the environment, Agencies have adopted or adapted the quality principles applied by Congress to risk information used and disseminated pursuant to the Safe Drinking Water Act (SDWA) Amendments of 1996 (42 U.S.C. 300g-1(b)(3)(A) & (B)). In these amendments, Congress emphasized that EPA must use the best available scientific evidence for risk information. Since the Information Quality Guidelines directed all Agencies to adopt this standard, Agencies were directed, "to the degree that an Agency action is based on science," to use: (i) the best available, peer-reviewed science and supporting studies conducted in accordance with sound and objective scientific practices; and (ii) data collected by accepted methods or best available methods (if the reliability of the method and the nature of the decision justifies use of the data). Additionally, the 1996 SDWA amendments directed EPA "to ensure that the presentation of information [risk] effects is comprehensive, informative, and understandable." The Information Quality Guidelines adopted this language and directed all Agencies: [I]n a document made available to the public in support of a regulation [to] specify, to the extent practicable:12 9 See ACC principles available at: https://www.americanchemistry.com/Chemical-Hazard-and-Risk-Assessmen Principles/ and further details at: https://www.americanchemistry.com/Policy/Chemical-Safety/Chemical- Assessments/Principles.pdf. 10 See for instance chapter 7 in the 2011 NAS Review of the Environmental Protection Agency's Draft IRIS Assessment of Formaldehyde available at: https://www.nap.edu/catalog/13142/review-of-the-environmental- protection-agencys-draft-iris-assessment-of-formaldehyde. 11 The Information Quality Guidelines are available at: https://georgewbush- hitehouse.archives.gov/omb/memoranda/fy2007/m07-24.pdf. 12 Bracketed language reflects changes to text for clarity. 4|Page Source: :ttps://www.industrydocuments.ucsf.edu/docs/zlcn0226 (i) each population addressed by any estimate [of applicable risk effects]; (ii) the expected risk or central estimate of risk for the specific populations [affected]; (iii) each appropriate upper-bound or lower-bound estimate of risk; (iv) each significant uncertainty identified in the process of the assessment of [risk] effects and the studies that would assist in resolving the uncertainty; and (v) peer-reviewed studies known to the [agency] that support, are directly relevant to, or fail to support any estimate of [risk] effects and the methodology used to reconcile inconsistencies in the scientific data. b. Memorandum on Updated Principles for Risk Analysis In 2007, OMB and the Office of Science and Technology Policy (OSTP) issued a joint memorandum to Executive Departments and Agencies on Updated Principles for Risk Analysis (Principles for Risk Analysis). 13 This memorandum was intended to reinforce the principles developed in 1995. While the focus was on actions directed at improving public health, safety, and the environment, it was noted that many of the principles were relevant to other fields, such as financial or information technology risk analyses. The Principles for Risk Analysis reiterated the requirements for best available science as they were articulated in the Information Quality Guidelines and presented further important information regarding the use of and presentation of assumptions, judgments, and uncertainties in risk analyses. For instance, among other requirements, the Principles for Risk Analysis require that: Judgments used in developing a risk assessment, such as assumptions, defaults, and uncertainties, should be stated explicitly. The rationale for these judgments and their influence on the risk assessment should be articulated.¹ 14 Results based on different effects and/or different studies should be presented to convey how the choice of effect and/or study influences the analysis. The presentation of information regarding different scientifically plausible endpoints should allow for a robust discussion of the available data, associated uncertainties, and underlying science. 15 Due to the inherent uncertainties associated with estimates of risk, presentation of a single estimate may be misleading and provide a false sense of precision. Expert panels agree that when a quantitative characterization of risk is provided, a range of plausible risk estimates should be provided. 16 13 See: https://georgewbush-whitehouse.archives.gov/omb/memoranda/fy2007/m07-24.pdf. 14 Ibid, at page 8. 15 Ibid, at page 8. 16 Ibid, at page 6. 5 P a g e Source: https://www.industrydocuments.ucsf.edu/docs/zlcn0226 c. Non-Governmental Reports on Improving Science in Regulations Improving Peer Review: In addition to government guidance, other consensus groups have spoken to the needs for ensuring high quality science. For instance, in 2009 the Bipartisan Policy Center put out a report entitled "Improving the Use of Science in Regulatory Policy."17 Important recommendations in this report included: The Administration needs to promulgate guidelines (through executive orders or other instruments) to ensure that when federal agencies are developing regulatory policies, they explicitly differentiate, to the extent possible, between questions that involve scientific judgments and questions that involve judgments about economics, ethics and other matters of policy. 18 The federal government, universities, scientific journals and scientists themselves can help improve the use of science in the regulatory process by strengthening peer review, expanding the information available about scientific studies, and setting and enforcing clear standards governing conflict of interest. 19 In 2012, the Keystone Center released a report entitled "Improving the Use of Science in Regulatory Decision-Making.*20 This report stressed the importance of consistency and transparency in selecting peer review panels and also noted that the regulatory process is better when there is a consistent, transparent and systematic review and evaluation of the scientific literature. The importance of a robust peer review process cannot be underestimated. Peer review is essential in the evaluation of scientific information to ensure the development of scientifically defensible assessments. It allows for the review of the underlying assumptions, methodology, criteria, and conclusions reached in the evaluation. Federal Agencies have several mechanisms available to them to conduct peer review of scientific information; however, these peer review processes and approaches are inconsistently applied, including the selection of peer review panel members and the consideration given to public and peer review comments. For example, during some EPA peer review meetings, the peer reviewers have appeared to be overly deferential to EPA and reluctant to be seen as criticizing EPA staff. We have also seen situations where peer reviewers have suggested discounting a study solely based on the funding source, without any consideration of the quality of the study. Also, EPA staff often comment throughout peer review meetings, essentially participating as peers, while stakeholders, including industry experts, are typically excluded from the 17 See: http://cdn.bipartisanpolicy.org/wp-content/uploads/sites/default/files/BPC%20Science%20Report%2Oful.pdf 18 Ibid, at page 4. 19 Ibid, at page 45. 20 See: ttps://www.keystone.org/wp-content/uploads/2015/08/091812-Research-Integrity-Roundtable-Report.pdf 6 Page Source: https://www.industrydocuments.ucsf.edu/docs/zlcn0226 dialogue. This practice undermines the integrity of the reviewers' role as independent and external to the assessment itself. Additionally, a critical element of peer review is the consideration of public comments. The public plays an important role in the review process by helping identify key scientific information and potential concerns with the assessment being evaluated. Unfortunately, within some Agencies, there is no robust consideration of public comments in the peer review process. For example, reviewers on the EPA Science Advisory Board (SAB) are not given clear advice regarding what it means to "consider" public comments. In fact we have seen SAB chairs ignore public input because they are not required to address it. When this has occurred, SAB staff have not clarified to the peer reviewers that they can and should respond to public input. Improving Systematic Review: The importance of systematic review in risk evaluation was mentioned in the 2012 Keystone Center report, and emphasized in a 2014 NAS report of its Review of EPA's Integrated Risk Information System (IRIS) Process. 21 This NAS panel noted that the use of systematic review approaches would "substantially strengthen" the IRIS process at EPA. Unfortunately, we have yet to see the IRIS program release an assessment that is consistent with these NAS recommendations. Data Access and the Protection of Confidential Business Information: Both the Bipartisan Policy Center report and the Keystone Center report discuss the need to protect proprietary business information. The legitimate need for protection must be balanced against public interest in the disclosure of relevant studies and data for the purposes of reproducibility. 22 The OMB Information Quality Guidelines recognize this tension and note that Even in a situation where the original and supporting data are protected by confidentiality concerns, or the analytic computer models or other research methods may be kept confidential to protect intellectual property, it may still be feasible to have the analytic results subject to the reproducibility standard. When it comes to environmental, health and safety information about chemicals, the Toxic Substances Control Act (TSCA) requires that EPA have access to that information. ACC member companies' current practice is to share summary results of industry studies with EPA or to provide raw data underlying health, safety and environmental studies with EPA upon request. Thus the Agency has the information it needs to ensure the safe regulation of chemicals, and EPA can rely on this information in its regulatory decisions. While any proprietary information must be protected, there are processes that exist to make robust study summary information available to the public in a manner that is sufficient to ensure public understanding of the data and address transparency demands. When it comes to full disclosure to the public, decisions to share raw data with non- regulatory bodies are made on a case by case basis. Companies weigh factors such as the 21 See: http://dels.nas.edu/Report/Review-Integrated-Risk/18764. 22 See the Keystone Center report at page 20. 7 I P a Source: https://www.industrydocuments.ucsf.edu/docs/zlcn0226 potential health/environmental impact of the product, the commercial value of the data, the age of the data, and other administrative, ethical, financial, legal, technical, and public health considerations. III. Science Standards in the 2016 Lautenberg Chemical Safety Act When the Lautenberg Chemical Safety for the 21st Century Act (LCSA23 was passed in 2016, it was the first time Congress directed a Federal Agency to consider not only the best available science but also the weight of the scientific evidence (WoE). These scientific standards, added to TSCA in Section 26 of the LCSA, have a prominent role in ensuring the Act achieves the fundamental objective of improving public confidence in the federal regulatory system. EPA now has a mandate to apply high quality, reliable and relevant scientific information. To date, EPA appears to be interpreting these scientific standards as implying that "business as usual" is consistent with the standards. EPA is reluctant to explicitly incorporate the best available science and WoE standards into the framework rules that it is developing to implement the LCSA. Instead, the Agency has suggested that simple reliance on existing guidelines and current practices are sufficient to meet the standards in Section 26. 24 This is of great concern to ACC. For example, Section 26(i) of the LCSA requires that EPA make decisions using a WoE approach. While a definition of WoE is not provided in the statute, the June 7 Congressional Record provides a definition that was entered into the record by Senator Boxer, the ranking minority member on the committee: Weight of the evidence means a systematic review method that uses a pre-established protocol to comprehensively, objectively, transparently, and consistently, identify and evaluate each stream of evidence, including strengths, limitations, and relevance of each study and to integrate evidence as necessary and appropriate based upon strengths, limitations, and relevance.25 This definition is also consistent with the June 2015 House Report language.26 Importantly, the definition refers to using a systematic review approach, as has been recommended by the Keystone Center report and the NAS in 2014. It also suggests that evidence be judged on its quality. Notably, EPA's proposed risk evaluation rule does not incorporate this definition. EPA has asked, however, for comment on this approach. 23 P.L. 114-182, 130 Stat. 448 (June 22, 2016). 24 EPA's draft framework rules for prioritization and risk evaluation can be found at: https://www.epa.gov/assessing. and-managing-chemicals-under-tsca/frank-r-lautenberg-chemical-safety-21st-century-act-5. 25 See Senate Congressional Record, June 7, 2016 at page S3518, available at: ttps://www.congress.gov/crec/2016/06/07/CREC-2016-06-07-pt1-PgS3511.pdf. 26 See House Report at page 33, available at: https://www.congress.gov/114/crpt/hrpt176/CRPT-114hrpt176.pdf 8 Page Source: https://www.industrydocuments.ucsf.edu/docs/zlcn0226 A recent example demonstrates that EPA apparently does not interpret WoE in the same way Congress did in the LCSA. In the draft risk assessment of 1-bromopropane (released prior to enactment of LCSA), EPA did not conduct a systematic review, and the draft assessment did not provide information regarding the quality of the individual studies. 27,28 Although the assessment identified some quality considerations, EPA did not provide any information regarding its own findings from its quality review of the individual studies. 29,30 Additionally, EPA did not describe how considerations were applied and what constitutes a study of "high quality" or "good quality." While EPA staff orally noted that they followed a WoE approach,31 EPA simply chose the value that provided the lowest point of departure and thus would be most health protective. The 1-bromopropane draft risk assessment is not consistent with the best available science or the WoE approach envisioned under the LCSA. If EPA chooses to simply follow current practices, the Agency will embark on a process that is not consistent with the new Section 26 science standards. Section 26 requires EPA to develop, within two years of enactment, any new policies, procedures and guidance that are necessary to ensure compliance with the LCSA. In addition, within five years of enactment and then once every five years, EPA is required to review these policies, procedures and guidance. This approach will ensure that EPA is consistently relying upon scientific approaches that are consistent with the state of the science. IV. Potential Solutions to Improving Agency Science ACC provides the following four recommendations to improve the science supporting regulatory decision making. a. Improve and Clarify Scientific Definitions ACC believes that the intent of Congress in drafting the scientific standards in the LCSA is clear. It is also clear that EPA's proposed interpretation diverges from Congressional intent in important respects. Clarifying that the intent of scientific standards is to improve existing Agency practices would be useful. In addition, providing clear and specific definitions for terms like best available science and WoE would be beneficial to the consistency, reliability and credibility of EPA's regulatory decisions. These definitions should address not only what Agencies should consider when evaluating scientific information, but also what information 27 See Comments of the American Chemistry Council on the TSCA Work Plan Chemical Draft Risk Assessment of I-Bromopropane Docket No. EPA-HQ-OPPT-2015-0084, May 9, 2016. 28 See peer review report/meeting minutes available at: https://www.regulations.gov/document?D=EPA-HQ-OPPT- 2015-0805-0028, at page 41 which states: "While the Agency indicates that the literature was thoroughly reviewed for robustness, adequacy, etc., the Committee found that it is not clear what exact methodology was used to systematically rate, rank, and select studies to inform sections of the risk assessment. For example, was a quantitative ranking system developed for study quality?" 29 Ibid. 30 See draft available at: :https://www.epa.gov/sites/production/files/2016-03/documents/1- bp report and appendices final.pdf at Appendix M. 31 See Chemical Safety Advisory Committee Meeting Transcript available at: https://www.regulations.gov/document?D=EPA-HQ-OPPT-2015-0805-0027;at page 130. 9 Page Source: https://www.industrydocuments.ucsf.edu/docs/zlcn0226 Agencies should present in evaluations. Requiring the Agencies to "show their work" and present their thought process in a transparent and clear manner would be have tremendous value. For example, adopting the language from the SDWA Amendments, we suggest the following definition of best available science: Best available science means information that has been evaluated based on its strengths, limitations and relevance and that the Agency is relying on the highest quality information. In evaluating best available science, the Agency will also consider the peer review of the science, whether the study was conducted in accordance with sound and objective practices, and if the data were collected by accepted methods or best available methods. To ensure transparency regarding best available science the Agency will describe and document any assumptions and methods used, and address variability, uncertainty, the degree of independent verification and peer review. Defining WoE clearly would also be advantageous. As noted previously, we suggest the definition articulated in the Senate debate on LCSA on June 7, 2016. When using this definition, it will also be important to clearly define the term "systematic review" as there may not be a uniform interpretation of that term among stakeholders. A particular concern in applying the best available science and weight-of-the-evidence is the tendency of federal agencies to use default assumptions, even when data are available. Despite more than 30 years of extensive mechanistic toxicological research by academia, research institutions and the private sector, some regulatory programs in EPA continue to rely on default approaches for hazard characterizations and risk assessments that date back to the 1970s. Even though frameworks for integrating mechanistic information and mode of action have been developed by authoritative bodies and incorporated into the EPA cancer risk guidelines, 32 at the present time, there is uneven use within EPA of such approaches in hazard characterizations and risk assessments. EPA's Office of Pesticide Programs has often determined, based on WoE evaluations that include consideration of mode of action and human relevance, that carcinogenic effects in animal studies are not relevant to humans or the carcinogenic effects are secondary to target organ toxicity, and thus no carcinogenic risks are posed to humans at doses below those which produce such toxicities. However, the IRIS program continues to rely on the 1970s default linear approach for cancer risk assessment. The IRIS program steadfast reliance on default linear approaches has significant consequences for many chemicals and can create tremendous costs to address "phantom risks" in site cleanups. 33 This outdated manner in which the EPA IRIS program deals with mode of action knowledge does not comport with use of best available science. Therefore, in implementing the definitions of best available science and WoE for the evaluation of the potential carcinogenic effects of substances, when supported by the scientific data, EPA should present non-linear modeling approaches consistent with the available data and scientific understanding of endogenous exposures and mode of action, in lieu of, or at a minimum in addition to, a linear default. Further, such assessments should include, in addition to upper 32 See EPA 2005 Guidelines for Carcinogen Risk Assessment 33 See George M. Gray and Joshua T. Cohen Nature 489, 27-28, 06 September 2012. 10 Page Source: https://www.industrydocuments.ucsf.edu/docs/zlcn0226 bound calculations, the distribution of estimated hazards or risks, including central tendency values, and clear criteria for when defaults are justified, including criteria for the application of uncertainty factors. b. Improve Oversight and Develop Quality Checklists Considering the guidance that already exists from OMB, other consensus bodies, and within the Agencies, stronger oversight to ensure that Agencies are following existing guidance could be highly effective. This oversight could come from independent offices within Agencies, Congress, or OMB or OSTP within the Executive Office of the President. One tool that may be effective is to develop a checklist to ensure that quality standards are met in scientific evaluations that support regulations. For instance, a recent publication from former EPA scientists has suggested that to promote transparency and consistency, risk evaluations could be compared to a guide or checklist which depicts all the important elements of a high quality assessment.34 Drs. Dellarco and Fenner-Crisp suggest that this guide "could be used by authors, sponsors, risk assessors, peer reviewers, and other interested stakeholders to determine if an assessment meets the current best scientific practices."355 c. Improve Peer Review Practices As noted earlier, the importance of a robust peer review process cannot be underestimated. Ensuring that peer review panels are composed of a diverse group of experts that have the breadth and depth of experience necessary to review scientific analyses in a transparent and comprehensive manner would be beneficial. It is also important to ensure that peer reviewers are fully independent from the program office issuing the assessment and conflicts of interest are fully evaluated and disclosed. More details on improving peer review can be found in the OMB Information Quality Bulletin for Peer Review, 36 as well as in reports from other consensus bodies, as discussed in Section II. d. Change Publication Incentives and Standards for Scientific Grants and Funding Much has been written about the lack of reproducibility of research findings published in peer reviewed journals. 37 The trend towards "publish or perish" puts immense pressure on researchers to publish findings, and in particular to publish predominantly positive findings. 38 Publication bias is common to published academic literature. This leads to bodies of literature in which the majority of publications support a given hypothesis. Publication bias stems from the fact there are many fewer incentives for publishing negative information or information that does 34 See publication available at: https://ehp.niehs.nih.gov/15-10483/. 35 Ibid 36 See: ttps://www.gpo.gov/fdsys/pkg/FR-2005-01-14/pdf/05-769.pdf. 37 See for example: http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.0020124,or http://www.nature.com/news/reproducibility-1.17552 38 See for example: :https://www.ncbi.nlm.nih.gov/pme/articles/PMC3999612/. 11 Page Source: https://www.industrydocuments.ucsf.edu/docs/zlcn0226 not support a hypothesis. Promotions and job security in academia, as well as having grants funded by Federal Agencies, are often tied to an author's publication record. Government Agencies can play an important role by 1) changing the incentives for grant funding such that decisions to fund research do not depend so heavily upon finding positive results and 2) putting in place standards to ensure that research studies are designed in a manner that will make them useable for regulatory decision making. Standards for funding could ensure that research studies follow best scientific practices and are designed with regulatory use in mind. For instance, for chemical risk assessment, studies should be designed to test more than three doses such that a dose-response analysis can be conducted. Unfortunately we have seen too many examples of government funded research where only one high dose is tested. While this information may have some value, it is then difficult to use these data to determine what impact the same chemical may have at more environmentally relevant lower dose ranges. If the government demanded a more robust study design when approving the research projects, the data obtained would likely be much more useful. V. Conclusion Ensuring that Federal decision making is firmly based on the use of high quality science is critical to helping the government meet its obligation to protect human health and the environment. This can be achieved through common sense reforms that will lead to more efficient and effective regulatory decisions. ACC looks forward to working with members of the Committee to enhance approaches to ensure that high quality science is the foundation to regulatory decision making. 12 I Page Source: https://www.industrydocuments.ucsf.edu/docs/zlcn0226 Appendix 1: Examples of Scientific Concerns with Federal Science Evaluations Below ACC provides a few specific examples where Federal Agencies have fallen short when it comes to using the best available science. a. Case 1: OSHA Crystalline Silica PEL Background OSHA finalized its workplace Permissible Exposure Limit (PEL) for crystalline silica in March, 2016. The final PEL reduced the standard from 100 g/m³ to 50 g/m³. Crystalline silica (commonly encountered as beach sand) is the second most abundant mineral in the Earth's crust. It is ubiquitous in rocks, gravel, sand and soils; plays a crucial role in construction and transportation; and is essential for many manufacturing processes and countless products. For example, it is a critical material for foundries and steel making, and is a key component of abrasives, paints, high-tech equipment, glass and ceramics. OSHA contended that the PEL of 100 g/m³ was not sufficiently protective. In fact, however, the data clearly shows that the incidence and rate of silicosis mortality have declined dramatically since adoption of the 100 g/m³ PEL in 1971, and the remaining cases can be attributed to higher silica exposures that were prevalent decades ago (allowing for latency) and to exceedances of the 100 g/m³ PEL. Moreover, the best evidence indicates that for silicosis and other potential pulmonary diseases, including lung cancer, there is a concentration-based threshold for silica exposure that exceeds 100 g/m³. Importance The new PEL is not economically feasible across multiple sectors of general industry and therefore will cause significant economic disruption throughout the economy. OSHA estimated that the annualized costs for all of general industry to comply with the revised standard would be $359 million. That estimate of compliance costs is deeply flawed and vastly understates the true costs of compliance, which are likely to be more than an order of magnitude higher. It would be far more cost-efficient and effective to bring all general industry employers into compliance with the longstanding PEL of 100 g/m³ rather than mandating that they attempt to comply with the new PEL of 50 g/m³. Scientific Concerns Because of its long latency period, silicosis cases seen today are attributable largely to exposures that occurred decades ago - in most cases, to exposures that began before OSHA's long-standing PEL of 100 g/m³ was even adopted. OSHA's argument that silicosis cases are underreported does not alter the fact that silicosis cases have dropped dramatically in the previous 40+ years, as silicosis cases have been underreported relatively consistently through that same time period. There are fundamental shortcomings and limitations in OSHA's risk assessment for all of OSHA's identified endpoints of concern: Important statistical errors in modeling and inference, including in particular a failure to adequately control for biases, which can lead to false positive results. 13 I Page Source: https://www.industrydocuments.ucsf.edu/docs/zlcn0226 A failure to properly model exposure measurement errors, which are common in the silica worker cohort studies in particular. Generally, uncertainties are not well characterized in the preliminary quantitative risk assessment. A failure by OSHA to carry out any causal modeling or analysis that would allow it to conclude that a reduction in the PEL would actually reduce adverse health effects. The alleged association between silica exposure per se and lung cancer remains controversial in the scientific community. OSHA did not properly weigh and consider the totality of the epidemiological evidence, discounting the significance of negative studies while choosing to highlight those studies that would confirm OSHA's position. Furthermore, as noted above, the best evidence points to an exposure concentration threshold for potential silica-related lung cancer that exceeds the PEL of 100 g/m³ that applied in general industry before the new rule was adopted in 2016. b. Case 2: EPA IRIS Assessment of Trimethylbenzenes (TMB) Background On September 9, 2016, EPA issued its final report on the IRIS assessment of Trimethylbenzenes (TMBs), which addresses the potential non-cancer and cancer human health effects from long- term exposure to TMBs. Humans are not exposed to individual TMB compounds, but to complex mixtures. According to EPA, the primary uses for TMBs are as a blending agent in gasoline formulations (C9 aromatic fraction); solvents; and as a paint thinner. In its review of TMBs, the EPA fell far short in meeting its obligations to improve its IRIS processes and assessment reports. Without explanation, EPA failed to respond to public comments on the draft TMBs assessment, even though the IRIS process for developing assessments explicitly includes a response to comments element. Importance As a final report, the IRIS assessment on TMBs will inform risk management decisions on TMBs by EPA's program and regional offices. Scientific Concerns The IRIS assessment of TMBs does not accurately represent the health effects associated with exposure to TMBs because EPA failed to utilize a consistent and transparent data evaluation procedure for evaluating and weighing the full body of evidence. In particular, EPA failed to rely on available guideline studies on commercial complex C9 aromatic mixtures that industry conducted under EPA's TSCA program. The entire commercial C9 aromatic blend, which contains a high percentage of TMBs, has similar toxicological properties and health effects as the individual isomers of TMB. Thus, guideline studies on the commercial complex of aromatic mixtures are highly relevant to assessing the toxicology of TMBs. EPA's Office of Pesticide Programs (OPP) has also reviewed the toxicology of TMBs and determined that the health effects of TMBs can be efficiently assessed by relying on C9 aromatic 14 Page Source: https://www.industrydocuments.ucsf.edu/docs/zlcn0226 mixture studies. OPP reached different scientific conclusions, including different quantitative health effect numbers, than that of EPA's IRIS Program. EPA, however, did not resolve these differences during the IRIS assessment of TMBs. c. Case 3: NIOSH Cancer Policy Background In the NIOSH Carcinogen Policy, released in December 2016, NIOSH states that underlying this entire policy is the "recognition that there is no known safe level of exposure to a carcinogen."39 ACC believes this statement is based on a default assumption and not clear scientific evidence, as certain carcinogens have thresholds or doses below which no adverse effects are identified. 40,41 Assuming that every chemical is toxic at high exposures and linear at low exposures does not comport with modern-day scientific knowledge of biology and there is no compelling evidence-based justification for a general low-exposure linearity. Instead, case- specific mechanistic arguments are needed. 42 d. Case 4: EPA IRIS Assessment of Ethylene Oxide (EO) Background EPA posted the final IRIS Assessment of EO in December 2016. EPA, using unsupportable, conservative, risk assessment modeling, concluded that the one-in-a-million lifetime cancer risk associated with exposure to EO is far below EO background levels currently in the environment and EO levels naturally converted from ethylene in humans through breathing. This conclusion is not plausible, and not scientifically supportable. It is based on an inadequate evaluation of a body of evidence from human studies that include historical exposure levels to 39 See NIOSH Carcinogen Policy available at: https://www.cdc.gov/niosh/docs/2017-100/default.html 40 See, for example Olden K, Vulimiri SV. 2014. Laboratory to community: chemoprevention is the answer. Cancer Prev Res (Phila). (7):648-52. http://cancerpreventionresearch.aacrjournals.org/content/canprevres/7/7/648.full.pdf at 650; which states: "Our understanding of toxicologic mechanisms has advanced considerably since the linear non- threshold model was adapted for cancer risk assessment. Knowledge of mechanism of action is critical for informing dose-response relationship below the experimental observable range. Johnson and colleagues (1) have used new technologies in analytical chemistry and molecular biology to characterize downstream biologic events in the exposure disease continuum. They showed that AFB1 is a classic genotoxic substance in that it binds covalently to DNA and induces mutations. In fact, DNA adduct formation exhibits a characteristic linear dose-response curve over a wide range. But, further analysis demonstrated a threshold mode of action, with respect to internal dose of active metabolite and hepatocarcinogenesis. That is, there was substantial adduct formation and DNA damage without having any affect [sic] on development of hepatocellular carcinoma." 41 See, for example: United States Environmental Protection Agency (EPA). 2015. Chemicals evaluated for carcinogenic potential office of pesticide programs, annual cancer report. Washington, DC. http://npic.orst.edu/chemicals evaluated.po EPA has determined that a number of substances that produce cancer at high doses are not likely to be carcinogenic to humans at low doses. 42 Rhomberg LR, Goodman JE, Haber LT, Dourson M, Andersen ME, Klaunig JE, Meek B, Price PS, McClellan RO, Cohen SM. 2011. Linear low-dose extrapolation for noncancer health effects is the exception, not the rule. Crit Rev Toxicol. 41(1):1-19.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3038594/pdf/btxc12-001.pdf and Bogen, KT. 2016. Linear-No-Threshold Default Assumptions for Noncancer and Nongenotoxic Cancer Risks: A Mathematical and Biological Critique. Risk Analysis Risk Analysis, Vol. 36, No. 3. ttp://onlinelibrary.wiley.com/doi/10.1111/risa.12460/pdf.. 15 Page Source: :ttps://www.industrydocuments.ucsf.edu/docs/zlcn0226 EO that are far higher than current occupational exposure limits. Other, more accurate, data sources are available, and alternative scientific risk assessment modeling approaches could have been used, but EPA made no serious, systematic attempt to integrate all of the evidence. Importance A determination by EPA that EO, with a myriad of important applications including the sterilization of medical equipment for surgery, can cause cancer at less than one part-per- trillion43 exposure will needlessly cause alarm and confusion, not only among workers, but also in the general population and in the public health and medical communities. These numbers are not reliably measurable, and are orders of magnitude below current endogenous and exogenous levels of EO. Scientific Concerns EPA did not adequately consider study quality into the IRIS review. Industry cohorts were not considered with the other epidemiology data sets even though this cohort was stronger than foreign cohorts used that contained occupational exposure interferences. EPA did not fully utilize linear and non-linear modeling approaches (as allowed within the cancer assessment guidance) to estimate cancer risk from current EO exposure levels and expected DNA repair mechanisms. EPA did not consider realistic exposure scenarios and fully delineate endogenous vs. exogenous EO and associated health impacts. In 2007, EPA's SAB identified problems with the linear regression modeling and low dose extrapolation for determining cancer risk. The SAB concluded that substantial revisions were needed in the IRIS assessment including: Acquiring and using individual data for modeling rather than grouping populations for modeling that currently results in overly conservative estimated cancer risks; Given the distribution of and questionable association with certain cancer types, considering using both linear and non-linear approaches to estimate cancer risk; Providing more transparency and correcting flaws associated with inappropriately grouping lymphohematopoietic (LH) cancers and combining genders for the dose- response analysis. In 2015, a specially selected SAB Committee reviewed a revised draft EO IRIS assessment. The committee, however, did not conduct an independent, unbiased review. Problems included: Inaccurate public statements by several SAB members indicating industry produced scientific studies should be disqualified due to potential industry influence, and the acceptance by SAB and IRIS staff of such a position; no evidence of biased data sponsored by industry was ever presented, and it is clear that those members advocating this position should have been disqualified due to these clear biased positions. 43 1 part per trillion is roughly equivalent to 1 second in 320 centuries or 1 inch in 16,000,000 miles 16 I Page Source: https://www.industrydocuments.ucsf.edu/docs/zlcn0226 Lack of understanding by SAB members of new evidence-based medicine concepts regarding mutagenicity of cancer cells and the contribution of naturally occurring EO in DNA repair mechanisms; Recommendation of epidemiology data sets with questionable or scientifically unsound characteristics to estimate cancer risk and rejection of alternative data sets that are as or more robust than those selected; EPA still did not use individual data for modeling as recommended in 2007, and did not seriously explore alternatives to the linear low dose modeling approach. Even though the SAB made extensive recommendations in its 2015 report and public comments were submitted on the IRIS draft reviewed by the SAB, EPA still did not respond fully to all comments submitted or implement all the changes recommended by the SAB. e. Case 5: National Ambient Air Quality Standard for Ground-Level Ozone Background In 2015, EPA lowered the National Ambient Air Quality Standard (NAAQS) for Ground-Level Ozone from 75 ppb to 70 ppb. Ozone, which is one of six criteria pollutants regulated under Section 109 of the Clean Air Act, is formed from a reaction between nitrogen oxide (NOx), volatile organic compounds (VOCs), and sunlight. Exposure to relatively high concentrations of ozone can cause adverse respiratory effects and interfere with plants' ability to produce and store food. In 2008, the ozone NAAQS was set at 75 ppb. Areas were not designated as complying or failing to comply with this standard until May 2012 due to unnecessary delays following the Obama Administration's premature reconsideration of the standard in 2010. This resulted in areas across the country not being allowed sufficient time to begin implementing the 2008 standard before EPA changed the standard again, which the Agency justified as being necessary to protect public health and welfare. However, a closer look at EPA's work during this most recent review process questions the need to revise down the standard. Scientific Concerns EPA relied on ecological epidemiology studies, also known as time-series analyses and clinical studies, as the basis to lower the ozone NAAQS to 70 ppb in 2015. However, EPA failed to adequately characterize the uncertainties associated with adverse health effects reported in these studies. Ecological epidemiology studies are not scientifically rigorous enough and are not designed to determine if ozone was responsible for the demonstrated the health effects. Clinical studies are limited by the small sample sizes and because they do not adequately consider the normal variation in the lung function. For example, in the 2015 standard, EPA relied on two new studies, Schelegle et al. (2009) 44 and Kim et al. (2011). 45 These studies both used a small sample which, while not unusual for a 44 Schelegle, ES; Morales, CA; Walby, WF; Marion, S; Allen, RP. 2009. 6.6-Hour inhalation of ozone concentrations from 60 to 87 parts per billion in healthy humans. Am. J. Respir. Crit. Care Med. 180(3):265-272. 45 Kim, CS; Alexis, NE; Rappold, AG; Kehrl, H; Hazucha, MJ; Lay, JC; Schmitt, MT; Case, M; Devlin, RB; Peden, DB; Diaz-Sanchez, D. 2011. Lung function and inflammatory responses in healthy young adults exposed to 0.06 ppm ozone for 6.6 hours. Am. J. Respir. Crit. Care Med. 183:1215-1221. 17 Page Source: https://www.industrydocuments.ucsf.edu/docs/zlcn0226 controlled human exposure study, proves difficult as a basis for drawing broader conclusions with regard to the protection of public health. EPA identified lung function decrements of only 2.8% to be adverse effects when the variation of lung function in normal subjects can vary by over 5% (Pellegrino et al. 2005)46 to 17.6% (Medarov et al. 2008.47 EPA must rely on biological, not just statistical, significance in identifying an adverse health and provide clear guidance on how to define adverse effects. Ultimately, these studies did not actually support health effects below the 75 ppb standard, and EPA primarily justified the regulation impacting 300 million people on study results from just a few individuals. 46 Pelligrino, R; Viegi, G; Brusasco, V; Crapo, RO; Burgos, F; Casaburi, R; Coates, A; van der Grinten, CPM; Gustafsson, P; Hankinson, J; Jensen, R; Johnson, DC; MacIntyre, N; McKay, R; Miller, MR; Navajas, D; Pedersen, OF; Wanger, J. 2005. Interpretive strategies for lung function tests. Eur. Respir J. 26: 948-968. 47 Medarov BI, Pavlov VA, Rossoff L. 2008. Diurnal variations in human pulmonary function. Int J Clin Exp Med. 1 (3) :267-273. 18 Page Source: :ttps://www.industrydocuments.ucsf.edu/docs/zlcn0226

What is the assumed compliance rate by this analysis?

gmcn0226

gmcn0226_p0, gmcn0226_p1, gmcn0226_p2, gmcn0226_p3, gmcn0226_p4, gmcn0226_p5, gmcn0226_p6, gmcn0226_p7, gmcn0226_p8, gmcn0226_p9, gmcn0226_p10

75% POST-RULE COMPLIANCE

the WHITE HOUSE BRIEFING ROOM ISSUES THE ADMINISTRATION 1600 PENN PRESIDENT BARACK OCAMA Home The Office of Management and Office of Management and Budget About OMBlog Budget Management Regulation & Information Intellectual Property Legislative Join Contact REGULATION & INFOKMATION Meeting Record Regarding: Lead; Renovation, Repair, About OIRA Federal Collection of and Painting Progrm Information Information Policy Meeting Record Regarding: Lead; Renovation, Repair, and Painting Progrm Date: 1/15/2008 Regulatory Matters Meetings and Outside Communication Name Affiliation Client (if applicable) Reports to Congress Robert Johansson OMB/OIRA For Agencies Maria Doa EPA Regulatory Reform Cindy Wheeler EPA Andrew Simons EPA Statistical Programs & Standards Matt Watkins NAHB A.J. Holliday NAHB Therese F Crahan NAHB Angela Hofmann EPA/OPPTS Frederick Talcott EPA/OPE/RAPD Nancy Beck OMB/OIRA Art Fraas OMB/OIRA Kevin Bromberg SBA/Advocacy Kevin Neyland OMB/OIRA Materials provided to OMB (2 pages, 227 kh) Source: https://www.industrydocuments.ucsf.edu/docs/gmcn0226 Economic Analysis for the Renovation, Repair, and Painting Program Proposed Rule Economic and Policy Analysis Branch Economics, Exposure and Technology Division Office of Pollution Prevention and Toxics U.S. Environmental Protection Agency February 2006 Source: https://www.industrydocuments.ucsf.edu/docs/gmcn0226 Executive Summary This report presents an economic analysis of alternative regulatory options to establish work practice standards, plus training and certification requirements, for persons engaged in renovation activities for compensation in housing units containing lead-based paint. These requirements apply to contractors who renovate, remodel and/or paint housing units where there is lead-based paint, as well as to residential building owners and managers who may perform these activities themselves or have their staff do so. The regulation is being proposed under authority of $402(c) of the Toxic Substances Control Act (TSCA). Title IV of TSCA was established by the Residential Lead-Based Paint Hazard Reduction Act of 1992, also known as Title X of the Housing and Community Development Act of 1992 (Public Law 102-550). Past use of lead-based paint has resulted in contamination that continues to pose human health hazards. Disturbing the lead-based paint, such as happens during renovation activities, is likely to create lead hazards. Since many residences built before 1978 have lead-based paint, it is likely that renovation activities occurring in these units will contribute to lead hazards unless appropriate containment and clean-up practices are employed. The Renovation, Repair and Painting (RRP) Rule is designed to prevent lead hazards from renovation activities. The training and work practice standards required and fostered by the proposed RRP rule will yield health benefits to individuals living in renovated units and to their neighbors. The proposed rule will reduce lead exposure by containing the lead contamination generated by renovation activities and reducing the amount of such contamination remaining after completion of the activities. EPA anticipates that the rule will further develop a market for lead-safe renovation services that has been established by past lead awareness rules, such as the $406(b) rule which requires compensated renovators to distribute lead awareness pamphlets to owners and occupants of most pre-1978 residential housing before beginning renovations. The proposed rule requires certification of firms (including self-employed contractors and property manager/lessors) that perform renovation, remodeling and/or painting in housing units subject to the regulations. A certified firm must assign to each renovation performed by the firm at least one renovator who has received formal training in EPA-approved work practices from an EPA-accredited course. In addition, certified firms must provide on-the-job training in these approved work practices for the rest of their staff who will be performing RRP activities in regulated housing. The proposed rule also requires containment of the work area to prevent the spread of dust and debris, specialized cleaning practices, and cleaning verification procedures to ensure that proper cleanup has occurred. EPA considered two regulatory approaches: prescriptive and flexible regulations for the proposed work practice standards. Under the prescriptive approach, EPA would require the use of specific work practices for all RRP jobs covered under the rule and that are at risk of causing lead contamination. The flexible approach relies on the required training, and the renovator's own experience, to determine the extent of containment needed in any particular situation. The flexible approach increases the cost effectiveness of the regulation by reducing work practice costs. This economic analysis considers four regulatory options with two phases. In Phase 1, Option A addresses pre-1978 housing, Option B and D both address pre-1960 housing, and Option C addresses pre- 1950 housing. In Phase 2, all the options address pre-1978 housing. In both phases coverage of the rule is limited to rental housing and owner-occupied housing where a child under the age of six resides. Table ES-1 describes the housing stock subject to the regulations under each of the four options. Options A, B $402(c) Economic Analysis Executive Summary 1 Source: :ttps://www.industrydocuments.ucsf.edu/docs/gmcn0226 and C are flexible in terms of the application of specific work practices while Option D is prescriptive. EPA is proposing Option B. Table ES-1: Definitions of the Regulatory Options First Year - Phase 1 Second Year - Phase 2 All renter-occupied target housing units built All renter-occupied target housing built before 1978, and owner-occupied target before 1978, and owner-occupied target Option A housing units built before 1978 where a housing units built before 1978 where a child under the age of six resides. Flexible child under the age of six resides. application of work practices Flexible application of work practices All renter-occupied target housing units built before 1960, and owner-occupied target housing units built before 1960 where a child under the age of six resides, plus all Option B Same as Option A. target housing units built before 1978 where a child with an increased blood-lead level resides. Flexible application of work practices All renter-occupied target housing units built before 1950, and owner-occupied target housing units built before 1950 where a child under the age of six resides, plus all Option C Same as Option A. target housing units built before 1978 where a child with an increased blood-lead level resides. Flexible application of work practices The prescriptive option. Covers the same The prescriptive option. Covers the Option D housing units as Option B - but requires same housing units as Option B - but specific work practices. requires specific work practices. a Where increased is defined as greater than or equal to 10 g/dL or a State or local government level of concern, if lower. The proposed rule is Option B. Cost of the Various Options For purposes of this analysis, the costs associated with the regulatory impact of the Renovation, Repair, and Painting (RRP) Rule are divided into three categories: (1) training costs, (2) work practice costs, and (3) certification costs (which include the firm's paperwork burden and government administrative and enforcement costs). The general approach of the analysis is to first estimate the number of affected activities or entities, then estimate the incremental regulatory cost per-activity or entity affected. Finally, the incremental costs and the number of affected activities and entities are combined to estimate the total costs. The number of RRP events covered by the rule varies across regulatory options in Phase 1 because the coverage of the regulation in Phase 1 varies across options, but under any of the options the number of events covered is substantial, as are the number of events that are performed in compliance with the rule. As shown in Table ES-2, approximately 10.7 million events per year would be conducted in compliance with the rule under Option A. Slightly more than one-half this amount, about 5.8 million events, would be conducted in compliance with the rule in the first year under Options B and D. In the first year, about 4.3 million events would be conducted in compliance with the rule under Option C. (Based on existing $402(c) Economic Analysis Executive Summary 2 Source: https://www.industrydocuments.ucsf.edu/docs/gmcn0226 literature about regulatory compliance rates in the construction industry, the analysis assumes that 75 percent of events in regulated housing are conducted in compliance with the rule.) In Phase 2 of the rule, the number of RRP events conducted in compliance with the rule is the same for all four options, about 4.4 million events per year. Because not all housing units built before 1978 have lead-based paint, the number of RRP events that need to use lead safe work practices (LSWP) is a subset of the total number of units covered by the rule. In Phase 1, between 8.1 million (Option A) and 3.7 million (Option C) events will use LSWP. In Phase 2, an estimated 4.4 million RRP events will be using LSWP. Despite the increased coverage of the rule in Phase 2, the number of events with LSWP in Phase 2 is smaller than in Phase 1 because the accuracy of lead paint test kits in terms of detecting the presence or absence of lead is expected to have improved by then. The current tests have a high false positive rate (estimated to average 63 percent), resulting in the frequent use of LSWP when they are not necessary, i.e., when lead is not present. The improved tests are expected to have a false positive rate of 10 percent. Table ES-2: Number of RRP Events Description of Options Number of Events per Year (millions) Work Phase 1 Phase 2 Phase 1 Phase 2 Phase 1 Phase 2 Practices Events with Events with Scope Scope Events Events Flexible? LSWP LSWP Option A Pre-78 R/C Pre-78 R/C Yes 10.7 8.1 10.7 4.4 Option Ba Pre-60 R/C Pre-78 R/C Yes 5.8 4.8 10.7 4.4 Option Ca Pre-50 R/C Pre-78 R/C Yes 4.3 3.7 10.7 4.4 Option Da Pre-60 R/C Pre-78 R/C No 5.8 4.8 10.7 4.4 Notes: R/C = All rental units plus owner-occupied units with children under the age of 6 years LSWP = Lead Safe Work Practices Number of events assumes 75% post-rule compliance In Phase I, paint spot tests assumed to have a false positive rate of 63%, in Phase 2 they are assumed to have a 10% false positive rate. a About 65 percent of U.S. households reside in buildings constructed before 1980, 34 percent reside in buildings constructed before 1960 and 22 percent reside in building constructed before 1950. Approximately 58 percent of all RRP events in pre-1978 and pre-1960 housing take place in renter-occupied or child-occupied housing. This percentage is slightly higher (about 63 percent) for RRP events in pre-1950 housing. Work practice costs are estimated for each of several types of RRP events and for different sizes of housing units. These unit costs are multiplied by the number of events of each RRP type and housing type to estimate the total work practice-related costs for each regulatory option. The RRP events and the range of unit costs associated with each type are shown in Table ES-3. $402(c) Economic Analysis Executive Summary 3 Source: https://www.industrydocuments.ucsf.edu/docs/gmcn0226 Table ES-3: Summary of Housing Unit Containment, Cleaning, and Verification Compliance Costs (2005$) Event Type Range of Costs per Event Low High Kitchen Remodel $28 $132 Bathroom Remodel $23 $63 Additions $26 $117 Non-Room-Specific Interior Wall $57 $528 Non-Room-Specific Window/Door6 $58 $528 Interior Paint $42 $285 Whole Exterior Remodel $161 $281 Exterior Remodel in Contained Area $77 $77 Exterior Paint $161 $281 a Events that involve changes to a wall or walls, where the location is not specified. For example: re-wiring or repair/replace heating or cooling systems. b Repair/replacement of windows and/or doors, where the room is not specified. c Outside repair/remodeling work that involves a specified part of the home, e.g. installation of a deck. Source: See Section 4.5.8. In addition to the number of covered RRP events in compliance with the rule and their unit costs, the other major factors in determining the costs of the rule are the number of firms certified, the number of personnel trained, and the costs of training and certification. All of the regulatory options require that each certified firm (including property managers and lessors who perform their own RRP work in regulated housing, as well as construction firms conducting RRP in regulated housing) employ at least one renovator who has taken an EPA-accredited training course and provide on-the-job training for all other staff who will be performing RRP activities in regulated housing. As shown in Table ES-4, the number of firms certified and the number of persons trained expands as the coverage of the rule expands. Thus Options B/D and C have larger numbers in the first year of Phase 2 than does Option A. By the second year of Phase 2, the number of firms certified and persons trained each year has leveled out to approximately 54 thousand firms certified or recertified, approximately 62 thousand renovators taking training or refresher courses, and nearly 277 thousand other workers getting on-the-job training each year. $402(c) Economic Analysis Executive Summary 4 Source: https://www.industrydocuments.ucsf.edu/docs/gmcn0226 Table ES-4: Estimated Number of Establishments Seeking Certification and Workers and Renovators Seeking Training Option A a Options B & Da Option Ca Year 1 Total Number of Establishments (with Employees and without) Seeking Certification c 163,979 86,539 59,571 Total Number of Renovators Trainedb.c 186,811 98,588 67,866 Total Number of Workers Trained b,c 279,221 147,357 101,437 Year 2 Total Number of Establishments (with Employees and without) Seeking Certification c 54,436 105,851 123,756 Total Number of Renovators Trained b,c 62,015 120,589 140,987 Total Number of Workers Trained b,c 278,076 278,076 278,076 Year 3 Total Number of Establishments (with Employees and without) Seeking Certification c 54,212 54,212 54,212 Total Number of Renovators Trainedb.c 61,761 61,761 61,761 Total Number of Workers Trained b,c 276,935 276,935 276,935 a About 65 percent of U.S. households reside in buildings constructed before 1980, 34 percent reside in buildings constructed before 1960 and 22 percent reside in building constructed before 1950. Approximately 58 percent of all RRP events in pre-1978 and pre-1960 housing take place in renter- occupied target housing units and owner-occupied target housing units where a child under the age of six resides. This percentage is slightly higher (about 63 percent) for RRP events in pre-1950 housing. Of the regulated housing, 75 percent are assumed to comply with the regulations. b Components may not add up to totals due to rounding. c The number of firms and individuals certified and trained, respectively, is reduced by 0.04 percent per year to account for housing that is removed from the regulated housing stock due to demolition or conversion to non-housing uses. Thus the demand for lead-safe renovation services is reduced over time. See Table ES-1 for option descriptions. Source: EPA calculations - see Section 4.3. The costs of the various regulatory options follow the number of events, with Option A having the largest costs under Phase 1 (see Table ES-5). Option D costs exceed the costs of Option B, even though they cover the same units, because Option D provides less flexibility in defining the extent of the area to be contained and cleaned. Option A costs decline substantially in Phase 2 for two reasons. First, most of the initial training and certification costs for Option A have been borne in Phase 1, while under Options B, C and D, a substantial amount of initial training and certification is occurring in Phase 2. Second, with the improved lead paint test kits available in Phase 2, the number of RRP events that use LSWP declines for all the options. The 50-year annualized costs provide a measure of the steady-state costs for each option. As shown, once the initial start-up costs have been absorbed, Options A through C have relatively similar annual costs of between $488 million and $505 million, using a 3 percent discount rate, or between $518 million and $551 million using a 7 percent discount rate. Option D continues to have substantially higher costs due to its prescriptive nature. The cost estimates account for the RRP events in the baseline that already use some of the work practices to be required under this rule. In situations where contractors are already using these practices they will experience a smaller increase in operating costs, which is accounted for in the cost estimates. All $402(c) Economic Analysis Executive Summary 5 Source: :https://www.industrydocuments.ucsf.edu/docs/gmcn0226 contractors that perform RRP in regulated housing, however, will incur the training and certification costs due to the rule. Table ES-5: Estimated Total Costs Description of Options Costs (millions 2005$) 50-Year Annualized Work Phase 1 Phase 2 Practices Phase 1 Phase 2 3% 7% Scope Scope Flexible? Discount Discount Rate Rate Option A Pre-78 R/C Pre-78 R/C Yes $ 924 $ 495 $ 505 $ 551 Option B Pre-60 R/C Pre-78 R/C Yes $ 531 $ 552 $ 492 $ 526 Option C Pre-50 R/C Pre-78 R/C Yes $ 393 $ 572 $ 488 $ 518 Option D Pre-60 R/C Pre-78 R/C No $ 645 $ 649 $ 588 $ 629 Notes: R/C = All rental units plus owner-occupied units with children under the age of 6 years Assumes 75% post-rule compliance In Phase I, lead paint test kits are assumed to have a false positive rate of 63%, in Phase 2 they are assumed to have a 10% false positive rate Benefits of the Rule The number of people protected by this rule varies with the variation in the universe of housing units covered by the rule. In Phase 1, Option A covers the largest number of individuals, including the largest number of children under the age of six years (see Table ES-6). By Phase 2, all options cover nearly 5.3 million individuals per year, including over 780 thousand children under the age of six years old. Similar to the cost estimates, the number of individuals and children protected assumes that 75 percent of RRP work will be in compliance after the rule takes effect, and that there is some baseline use of LSWP. Based on the limited amount of information currently available about the baseline use of LSWP, the analysis assumes that approximately 20 percent of individuals and children living in regulated units with RRP already receive the benefits that the rule would provide. As discussed earlier, based on other compliance studies, this analysis assumes a compliance rate of 75 percent. However, the Agency's goal continues to be 100 percent compliance. If that goal were achieved, then over 1 million children under the age of six years old would be protected by the rule. At that rate, however, both the costs and the benefits would be higher than shown in the other tables. $402(c) Economic Analysis Executive Summary 6 Source: https://www.industrydocuments.ucsf.edu/docs/gmcn0226 Table ES-6: Number of Individuals Protected by the Regulatory Options Number of Individuals Occupying Units with LBP, where Description of Options LSWP are Used Due to the Rule (thousands per year) Children under 6 Years of Age All Individuals Work 100% Phase 1 Phase 2 75% Compliance 75% Compliance Practices Compliance Scope Scope Rate Rate Flexible? Rateb Phase 1 Phase 2 Phase 2 Phase 1 Phase 2 Option A Pre-78 R/C Pre-78 R/C Yes 787 783 1,138 5,309 5,287 Option B Pre-60 R/C Pre-78 R/C Yes 668 783 1,138 4,529 5,287 Option C Pre-50 R/C Pre-78 R/C Yes 520 783 1,138 3,659 5,287 Option D Pre-60 R/C Pre-78 R/C No 668 783 1,138 4,529 5,287 Notes: R/C = All rental units plus owner-occupied units with children under the age of 6 years LSWP = Lead Safe Work Practices In Phase 1, lead paint test kits are assumed to have false positive rate of 63%, in Phase 2 they are assumed to have a 10% false positive rate "Number of individuals is incremental above those occupying units where LSWP are currently practiced in the baseline. b If 100 percent compliance were achieved, both the costs and the benefits would be higher than shown in the tables based on 75 percent compliance. Lead causes a number of adverse health effects in people of all ages. Of particular concern are children under the age of six years, but older children and adults also suffer effects from lead exposure In this analysis, only a few of these health effects have been quantified. One of the factors restricting the scope of the benefits estimation is the limited amount of available data, including well-specified dose response relationships, on which to quantify and monetize many of the health and developmental effects. Therefore this benefits assessment focuses on two major categories of health effects: effects on cognitive function in young children (under the age of six) and cardiovascular disease (hypertension, coronary heart disease and stroke) and premature mortality in adults. There are additional uncertainties in the quantification of adult effects, which are addressed in Section 5.5.5. Even where the dose-response relationships are known, many cases are not included in the estimates because exposure levels cannot be estimated for all potentially affected individuals. For example, the benefit estimates presented in this report are based on reductions in lead ingestion; they do not include reductions in lead inhalation, although that is also likely to occur. Likewise, benefits are estimated only for people living in the housing units; they do not include potential benefits to visitors or neighbors. In addition, ecological benefits, as well as benefits to family pets, are not included in the estimates. It is important to note that the monetary values assigned to the avoided adverse health effects are based on medical costs avoided, not willingness-to-pay to avoid these ailments and/or premature death. Likewise, the value of the IQ points that will be gained due to this rule are valued in terms of increased earnings, not willingness-to-pay.¹ 1 Note that dose-response functions only allow for estimating IQ impacts among children less than six years of age, and the health effects only for adults over the age of 40. Other groups who are among the total individuals occupying units with lead-based paint in Table ES-6 are not included in the benefit estimates. $402(c) Economic Analysis Executive Summary 7 Source: :https://www.industrydocuments.ucsf.edu/docs/gmcn0226 This analysis estimates the benefits of the proposed regulation in terms of IQ deficits in children and increased blood pressure and related health effects in adults. Quantitative estimates of benefits are provided in two scenarios. Scenario 1 quantifies benefits for both children and adults. Scenario 2 assumes additional cleaning in the baseline compared to Scenario 1, and only quantifies benefits for children. This approach is in recognition of the relatively larger uncertainties associated with adult health effects (pending completion of other EPA documents), as well as the particular concern about children expressed in Title X of the Residential Lead-Based Paint Hazard Reduction Act of 1992. The Agency is more confident in the estimates for children's IQ effects then it is for the estimates of adult benefits. While recognizing that adults may also benefit from the training and practices required under the rule, Scenario 2 does not try to quantify these benefits due to the uncertainties that currently exist. Net Benefits Based on the subset of benefits that have been monetized in this analysis, Table ES-7 and Table ES-8 display the annualized net benefits estimated for the four regulatory options under Scenarios 1 and 2, respectively. Each table presents annualized net benefits calculated at both a 3 percent and a 7 percent discount rate. Net benefits under Scenario 1 are substantially greater than those under Scenario 2. Scenario 1 assumes less baseline cleaning than Scenario 2 and it quantifies adult health benefits as well as children's IQ benefits. Under either Scenario, annualized net benefits calculated using a 7 percent discount rate are slightly larger than those calculated using a 3 percent discount rate. Under both scenarios and all options net benefits are positive, i.e., the benefits are larger than the costs. When comparing options on the basis of annualized net benefits, there is relatively little difference among the three flexible options (Options A, B and C). This is not surprising, since the primary differences in these options occur in the first year the rule takes effect. After that year, all options address the same universe of pre-1978 housing. And after the second year, the population of firms and renovators being trained and re-trained levels off to approximately the same number each year. The only substantial difference is between the flexible options and the prescriptive Option D. The lack of flexibility appears as a roughly $100 - $150 million reduction in annualized net benefits as compared to the other options. $402(c) Economic Analysis Executive Summary 8 Source: https://www.industrydocuments.ucsf.edu/docs/gmcn0226 Table ES-7: Comparison of Options - Scenario 1 -- Annualized Costs and Net Benefits Children's IQ Adult Health Sum of Children's Net Benefits - Annualized Benefits - Benefits - IQ and Adult Children's IQ Cost Annualized Annualized Benefits -- and Adult Health (millions (millions (millions Annualized -- Annualized e 2005$ 2005$) 2005$) b (millions 2005$) (millions 2005$) Annualized using 3 Percent Discount Rate Option A $ 505 $947 $5,336 $2,262 $3,209 - $7,599 $2,704 - $7,093 Option B $ 492 $941 - $5,311 $2,250 $3,191 - $7,562 $2,699 - $7,069 Option C $ 488 $934 - $5,267 $2,235 $3,170 - $7,503 $2,682 - $7,015 Option D $ 588 $941 $5,311 $2,250 $3,191 - $7,562 $2,603 - $6,973 Annualized using 7 Percent Discount Rate Option A $551 $1,008 - $5,680 $2,408 $3,415 - $8,087 $2,865 - $7,537 Option B $526 $997 - $5,633 $2,385 $3,383 - $8,019 $2,857 - $7,493 Option C $518 $984 $5,551 $2,358 $3,342 - $7,909 $2,824 - $7,391 Option D $629 $997 - $5,633 $2,385 $3,383 - $8,019 $2,754 - $7,390 a Developed in Chapter 4 b Developed in Chapter 5 - range for children's IQ benefits reflects alternative models for blood lead, exposure estimates and population of children c Difference between sum of benefits and costs Table ES-8: Comparison of Options - Scenario 2 - Annualized Costs and Net Benefits Annualized Children's IQ Benefits Net Benefitsd - Costb - Annualized° Children's IQ Only (millions 2005$) (millions 2005$) (millions 2005$) Annualized using 3 Percent Discount Rate Option A $ 505 $774 $4,354 $269 $3,849 Option B $ 492 $770 $4,329 $277 $3,837 Option C $ 488 $764 $4,298 $276 $3,810 Option D $ 588 $770 $4,329 $181 $3,741 Annualized using 7 Percent Discount Rate Option A $551 $824 $4,635 $273 $4,084 Option B $526 $816 $4,587 $290 $4,061 Option C $518 $805 $4,530 $287 $4,012 Option D $629 $816 $4,587 $187 - $3,958 a While recognizing that adults will benefit from the rule, Scenario 2 does not try to quantify adult benefits. There are additional uncertainties in the quantification of adult effects, which are addressed in Section 5.5.5. b Developed in Chapter 4 c Developed in Chapter 5 - range reflects alternative models for blood lead, exposure estimates and population of children d Difference between sum of benefits and costs $402(c) Economic Analysis Executive Summary 9 Source: https://www.industrydocuments.ucsf.edu/docs/gmcn0226

What does IRIS stand for?

gzbn0226

gzbn0226_p0, gzbn0226_p1, gzbn0226_p2, gzbn0226_p3, gzbn0226_p4, gzbn0226_p5, gzbn0226_p6

INTEGRATED RISK INFORMATION SYSTEM, Integrated Risk Information System.

American Chemistry Council AMERICAN CHEMISTRY MATTERS A Blog of the American Chemistry Council Driving Innovation. Creating Johs and Enhancing Safety Matters Bements Contributars Archives Contact About Take Action ACC Newsroom Members in f a About Nancy Beck, Ph.D., D.A.B.T. Senior Director, Regulatory Science Policy I American Chemistry Council On the road with #ACCaugust - -2015 Chemicals in food: Top chemical food myths debunked. naturally) (video) Nanotechnology could be the next big thing Author Archive: Nancy Beck, Ph.D., D.A.B.T. in medical care Fueling Export Growth (Part 2 of 2): Why Carcinogen or not a carcinogen? A tale of two WHO the expected surge in U.S. chemicals exports will depend on our country' S ability Agencies, and the importance of evaluating study to deliver on its ambitious trade agenda quality and human relevance Fueling Export Growth (Part 1 of 2): U.S chemical exports linked to natural could by Nandy Geok Ph. & D.A.B.I. or 2016 in FOLIOY double by 2030; plastics products leading the surge How is il possible that two World Health Organization (WHO) agencies could evaluate the same chemical's potential to cause cancer and come to seemingly opposite conclusions? Dr. David Gastmond explored this question in a presentation at the Summer Toxicology Forum meeting comparing the approaches taken by the International Agency for Research on Cancer (IARC) and (...) RSS SUBSCRIPTION READ FULL STORY WELCOME TO THE BLOG OF THE AMERICAN CHEMISTRY COUNCIL The pursuit of quality in risk assessment Search Q by Nancy Geok. 26.0 DABT on SEFTOVEER 16, 2016 :83 ECLICY The Toxicology Forum is an international organization that encourages dialogue among government agencies, industry, academia, policymakers, and NGOs concerned with public health issues. Following Congress's TOP recent passage of the Lautenberg Chemical Safety Act, the Toxicology Forum's summer meeting in Salt Lake The Washinaton post City, featured a particularly interesting and timely session on "the pursuit of quality and 1..] - READ FULL STORY Facebook What a "defective" radiation-risk standard can teach US Tweets by @AmChemistry Source: https://www.industrydocuments.ucsf.edu/docs/gzbn0226 about improving chemical risk assessments by Beck on 28. 2016 in POUCY Wall Street Journal editorial board member Holman W. Jenkins, Jr. seems to have a knack for battling bad science which especially what he perceives to be misguided reporting and alarmist stories about climate change. in his most recent piece, Jenkins laments the fact that some activisis have used faulty research to overstate the risks associated [...] READ FULL STORY Fixing EPA's chemical assessment program - Latest reviews show IFIS is still a work in progress by Nanoy Beok Eb.D. DABT on FEERUARY 22, 2016 in INDUSTEY It's hard to believe but this year marks the filth anniversary of the National Academy of Sciences' (NAS) 2011 report on the Environmental Protection Agency's (EPA) integrated Risk information System (IRIS) program. The report identified systemic problems and offered sweeping recommendations to overhaul the program. So what has happened in the five years since the [...] READ FULL STORY Grappling with uncertainty: New paper offers D. a better approach by Beok. DABIT or FEBRUARY 16. 2016 in INDUSTEY As Donald Rumsfeld taught us, how you handle and communicate what you don't know is just as important as dealing with what you do know. A new paper recently published by the scientific journal Environment International offers several different ways to help better address the uncertainty conundrum when it comes to sharing the results of [...] READ FULL STORY Had we been given the opportunity, here's what we would have offered the NIEHS on its new NTP PloC Handbook by Nancy, Beck of DABT. on SEPTEMBER 28. 2015 in INDUSTRY One way in which the National institute of Environmental Health Sciences (NIEHS) National Toxicology Program (NTP) could demonstrate its commitment to transparency is by seeking public comment on its guidance documents prior to finalizing and implementing them. Not only would this help NTP to develop a robust approach, but it would also allow outside experts, (... READ FULL STORY IFIS progress report details key improvements, but the Source: https://www.industrydocuments.ucsf.edu/docs/gzbn0226 bar must be raised higher by Nancy Back. Ph. on MAY 13. 2018 in According to a May 2015 progress report to Congress, the Environmental Protection Agency's (EPA) Integrated Risk Information System (IRIS) is better off than it was a year ago, but not as effective as it needs to be to deliver timely, high-quality and credible chemical risk assessments. EPA does deserve credit, first and foremost, for following (...) READ FULL STORY Returning to fundamental principles can help science live up to the public trust by Nancy Back. Eb.D. D.A.S.T. on NOVEMEER24 2014 in POLICY A revised approach in the biomedical sciences for reporting research should set a strong precedent for researchers, publishers, and regulators around the U.S. who are committed to improving the science that guides public health decisions, Scientists today are more prolific than ever. The sheer body of research published every year can be overwheiming-trom breakthroughs in .... READ FULL STORY Two keys to a stronger chemical assessment program: Planning for success and avoiding pitfalls by Nancy. Beck. Ph D. D.A.S.T. on OCTOBER 14. 2014 in INDUSTEY This week's Integrated Risk information System (IRIS) workshop on the National Research Council's (NRC) recommendations for improving federal chemical assessments gives the U.S. Environmental Protection Agency (EPA) an opportunily to build on the progress it has already made in creating a sound, more transparent, and objective assessment program. While the agenda for the workshop covers READ FULL STORY What are the key challenges for improving risk sessments? Two experts weigh in by Nancy Beak. Ph.D. on MAYA, 2014 in POLICY Two recurring themes at the 53rd meeting of the Society of Toxicology (SOT) in Phoenix, Arizona, were enhancing strategies for risk assessment and finding new ways to conduct safety assessments. Here are three questions (and some potential answers) that continue to drive the debate. What are the biggest issues for the future of risk assessment? READ FULL STORY / a Next BLOGROLL TRENDING ELEMENTS Source: https://www.industrydocuments.ucsf.edu/docs/gzbn0226 ACC's Principles for Improving Chemical Hazard and Risk Assessments Assessments should focus on understanding the inherent properties of substances in order to determine the likelihood of harm from a specific exposure. The public, businesses and regulators look to government Design assessments for reliable information about the potential hazards and risks associated with chemicals. Identify Key Science Issues Use Modern Science and Tools Prior to Initiation of Assessment Use relevant data Discuss the purpose, scope and technical approaches Consider how chemicals act in the body I Engage stakeholders Evaluate chemicals at relevant exposure levels Data and Methods Apply Objective Criteria Integrate Evidence Develop and apply consistent criteria for selecting Give the greatest weight to information from the and evaluating a study, before an assessment begins highest-quality and most-relevant studies Evaluate all studies to determine their quality, Transparently and objectively integrate evidence relevance and reliability to make realistic determinations of hazards and risks; consider all types of evidence Ensure Assessments Characterize Hazards and are Transparent Risks Fully and Accurately Communication Disclose key information and assumptions used Present hazards and risks in an easy-to- understand to develop assessments and reach conclusions manner to stakeholders and risk managers Make materials, including important data sets, Present a range of plausible values, including publicly available central estimates when going beyond a screening level assessment Conduct Scientific Peer Review by Improve Accountability O Independent Experts Use an independent accountability procedure to Ensure peer reviewers are fully independent from the verify that revised assessments are accurate program office issuing the assessment and responsive to scientific and peer review Review and Evaluate peer review panels for conflicts of interest; ensure panels contain a balance of perspectives and appropriate technical expertise RESULT. Public Trust in High-Quality Risk Assessment Source: https://www.industrydocuments.ucsf.edu/docs/gzbn0226 Formaldehyde Assessments Must Properly Evaluate and Integrate All Available Evidence Data and A fully integrated chemical assessment requires that all available scientific Methods evidence is evaluated for quality and relevance, then analyzed together to make an informed decision. Mechanistic Data WHAT THE is Animal Data SCIENCE TELLS US: (Studies about what a chemical does (Experimental data from in the human body and how it does it) animal lab studies) When integrating the three Compelling evidence shows that types of evidence, it is clear The best-available studies show inhaled formaldehyde does not that the data do not support a that inhaled formaldehyde has no reach bone marrow (Swenberg relationship between inhaled effect on blood or bone marrow. et al. 2011). formaldehyde and leukemia A recent NTP study on two There are no reliable, in humans. strains of mice genetically high-quality mechanistic data predisposed to develop leukemia available to support speculation to high doses of inhaled that formaldehyde causes formaldehyde and confirmed no leukemia. leukemia effects. Epidemiological Data (Studies of select human populations) Extensive and detailed critical reviews of epidemiological literature do not support a causal relationship between formaldehyde exposure and leukemia. When data from three large, high-quality studies are combined, the number of leukemia cases in the studied occupationally-exposed populations is essentially the same as what is expected in the U.S. population (152 v. 153), indicating there is no appreciable risk for developing leukemia. Source: https://www.industrydocuments.ucsf.edu/docs/gzbn0226 American Chemistry Council AMERICAN CHEMISTRY MATTERS A Blog of the American Chemistry Council Driving Innovation, Creating Jobs and Enhancing Safety Matters Elements Contributors Archives Contact About Take Action ACC Newsroom Members f n Returning to fundamental principles can help science LATEST TAGS live up to the public trust On the road with #ACCaugust 3.0 by Nancy Beck. Ph D. D.A.B.T. on NOVEMBER 24. 2014 in POUSY AUGUST 25, 2017 f Facebook Chemical industry prepared for new storm Linkedin 2 heading to U.S. guli coast AUGUST 24, 2017 Issues around listing chemicals under Prop A revised approach in the biomedical sciences for reporting research should set a strong precedent for 65 researchers, publishers, and regulators around the U.S. who are committed to improving the science that AUGUST 8, 2017 guides public health decisions. Scientists today are more prolific than ever. The sheer body of research published every year can be breakthroughs in innovation, to new health and safety studies, to novel solutions to improve environmental health. If there is one thing that should ground them all in the public trust, it should be a commitment to adhering to an established sound scientific process. Search Q Unfortunately, many of the scientific studies we read about in the news were not quite ready for prime time. Forbes contributor Geoffrey Kabat wrote in a November 15 piece that often il is the "anomalous, and almost certainly wrong, results" that can get the most attention. As Kabat points out, these inconsistent results can PREVIOUS POSTS have serious ramifications for public health: Previous Posts Select Month 66 This phenomenon leads to an enormous waste of resources, which comes at the expense of research that might actually lead to saving lives. it also confisses the public and leads people to mistrust science generally. Many in the scientific community agree, and at least one group of editors has already begun to lead a return to the fundamental principles of science to restore public confidence. Journals stand up for science "Reproducibility, rigor, transparency, and independent verification are comerstones of the scientific method," Editor-in-Chief Marcia McNutt made clear at the opening of a November 7 editorial published in the journal Science. According to McNutt, a swath of aditors from more than 30 major journals, together with funding agencies and other scientific leaders met at the American Association for the Advancement of Science headquarters sartier this year to tackie the reproducibility issue plaguing so many prectinical studies of late. Below is a list of guidelines they agreed to as first big step toward improving the integrity of the biomedical sciences: Journais should make il clear to authors the policies for statistical analysis and how they review the statistical accuracy of work under consideration Source: https://www.industrydocuments.ucsf.edu/docs/gzbn0226 Any imposed page limits should not discourage reproducibility (in other words, researchers should be given the time and space to show their work) Researchers should use a checklist to ensure the reporting of important experimental parameters: standards used, number and type of replicates, statistics, method of randomization, whether experimenters were blind to the conduct of the experiment, how the sample size was determined, and what criteria were used to include or exclude any data Journals should recommend that data be placed in public repositories, where available, and linked to the paper to ensure proper attribution Journals should ensure that all datasets relied upon for conclusions in the paper are made available upon request, where ethically appropriate, by editors and reviewers; in addition, journals should encourage the release of data for sharing after publication Once a journal publishes a paper, it should assume the obligation to consider publication of a refutation of that paper, subject to its usual standards of quality Journals should consider establishing best practices guidelines for images and biological material use. Valuable tessons for Improving chemical assessments Because of their fundamental nature, the guidelines have tremendous potential to help the public beyond their use by journals and beyond the biomedical science field. For example, many of the guidelines proposed in McNutt's editorial are consistent with the recommendations that have been recently offered to improve how federal programs are evaluating chemicals. For example, there are many parallels when it comes to improving the review and transparency of the research used in chemical assessment programs. in several cases, these concepts are in line with ACC's principles for enhancing federal risk assessment, especially when it comes to evaluating data and selecting studies used in assessments and providing full disclosure of underlying data and key information used to develop assessments. Fully implementing these improvements to chemical assessments will provide regulators, the public, and industry with more accurate and useful information to help guide better decisions for protecting human health and the environment. Call to action Now that leaders in the biomedical sciences have acknowledged that their journals may not always meet scientific standards of reproducibility, rigor, transparency and independent verification, it's time that researchers and journals that examine chemicals do the same. The American Association for the Advancement of Science (AAAS) pledge should serve as a wake-up call to researchers and journals across the toxicological sciences to step up their game by renewing their commitment to the scientific method. And regulators can help facilitate this "return to the science" by rigorously reviewing existing published studies to ensure they meet these core tenels of the scientific method and calling on journals to publish more robust, independently verified studies going forward, As McNutt concludes, "The hope is that these guidelines will not be viewed as onerous, but as part of the quality control that justifies the public trust in science." S Facebook Linkedin American Association for the Adyanosment of Sciance. Chamical Assessment, Kabat, Marcia McNutt. Risk. Safety NANOSAFE 2014 conference in France features paper aconsored by ACC's Panal Versatile, Durable. incendible Macy's Thankegiving Day Parade Balloons! Source: https://www.industrydocuments.ucsf.edu/docs/gzbn0226

Where was the 53rd meeting of the Society of Toxicology held?

gzbn0226

gzbn0226_p0, gzbn0226_p1, gzbn0226_p2, gzbn0226_p3, gzbn0226_p4, gzbn0226_p5, gzbn0226_p6

Phoenix, Arizona., PHOENIX, ARIZONA

American Chemistry Council AMERICAN CHEMISTRY MATTERS A Blog of the American Chemistry Council Driving Innovation. Creating Johs and Enhancing Safety Matters Bements Contributars Archives Contact About Take Action ACC Newsroom Members in f a About Nancy Beck, Ph.D., D.A.B.T. Senior Director, Regulatory Science Policy I American Chemistry Council On the road with #ACCaugust - -2015 Chemicals in food: Top chemical food myths debunked. naturally) (video) Nanotechnology could be the next big thing Author Archive: Nancy Beck, Ph.D., D.A.B.T. in medical care Fueling Export Growth (Part 2 of 2): Why Carcinogen or not a carcinogen? A tale of two WHO the expected surge in U.S. chemicals exports will depend on our country' S ability Agencies, and the importance of evaluating study to deliver on its ambitious trade agenda quality and human relevance Fueling Export Growth (Part 1 of 2): U.S chemical exports linked to natural could by Nandy Geok Ph. & D.A.B.I. or 2016 in FOLIOY double by 2030; plastics products leading the surge How is il possible that two World Health Organization (WHO) agencies could evaluate the same chemical's potential to cause cancer and come to seemingly opposite conclusions? Dr. David Gastmond explored this question in a presentation at the Summer Toxicology Forum meeting comparing the approaches taken by the International Agency for Research on Cancer (IARC) and (...) RSS SUBSCRIPTION READ FULL STORY WELCOME TO THE BLOG OF THE AMERICAN CHEMISTRY COUNCIL The pursuit of quality in risk assessment Search Q by Nancy Geok. 26.0 DABT on SEFTOVEER 16, 2016 :83 ECLICY The Toxicology Forum is an international organization that encourages dialogue among government agencies, industry, academia, policymakers, and NGOs concerned with public health issues. Following Congress's TOP recent passage of the Lautenberg Chemical Safety Act, the Toxicology Forum's summer meeting in Salt Lake The Washinaton post City, featured a particularly interesting and timely session on "the pursuit of quality and 1..] - READ FULL STORY Facebook What a "defective" radiation-risk standard can teach US Tweets by @AmChemistry Source: https://www.industrydocuments.ucsf.edu/docs/gzbn0226 about improving chemical risk assessments by Beck on 28. 2016 in POUCY Wall Street Journal editorial board member Holman W. Jenkins, Jr. seems to have a knack for battling bad science which especially what he perceives to be misguided reporting and alarmist stories about climate change. in his most recent piece, Jenkins laments the fact that some activisis have used faulty research to overstate the risks associated [...] READ FULL STORY Fixing EPA's chemical assessment program - Latest reviews show IFIS is still a work in progress by Nanoy Beok Eb.D. DABT on FEERUARY 22, 2016 in INDUSTEY It's hard to believe but this year marks the filth anniversary of the National Academy of Sciences' (NAS) 2011 report on the Environmental Protection Agency's (EPA) integrated Risk information System (IRIS) program. The report identified systemic problems and offered sweeping recommendations to overhaul the program. So what has happened in the five years since the [...] READ FULL STORY Grappling with uncertainty: New paper offers D. a better approach by Beok. DABIT or FEBRUARY 16. 2016 in INDUSTEY As Donald Rumsfeld taught us, how you handle and communicate what you don't know is just as important as dealing with what you do know. A new paper recently published by the scientific journal Environment International offers several different ways to help better address the uncertainty conundrum when it comes to sharing the results of [...] READ FULL STORY Had we been given the opportunity, here's what we would have offered the NIEHS on its new NTP PloC Handbook by Nancy, Beck of DABT. on SEPTEMBER 28. 2015 in INDUSTRY One way in which the National institute of Environmental Health Sciences (NIEHS) National Toxicology Program (NTP) could demonstrate its commitment to transparency is by seeking public comment on its guidance documents prior to finalizing and implementing them. Not only would this help NTP to develop a robust approach, but it would also allow outside experts, (... READ FULL STORY IFIS progress report details key improvements, but the Source: https://www.industrydocuments.ucsf.edu/docs/gzbn0226 bar must be raised higher by Nancy Back. Ph. on MAY 13. 2018 in According to a May 2015 progress report to Congress, the Environmental Protection Agency's (EPA) Integrated Risk Information System (IRIS) is better off than it was a year ago, but not as effective as it needs to be to deliver timely, high-quality and credible chemical risk assessments. EPA does deserve credit, first and foremost, for following (...) READ FULL STORY Returning to fundamental principles can help science live up to the public trust by Nancy Back. Eb.D. D.A.S.T. on NOVEMEER24 2014 in POLICY A revised approach in the biomedical sciences for reporting research should set a strong precedent for researchers, publishers, and regulators around the U.S. who are committed to improving the science that guides public health decisions, Scientists today are more prolific than ever. The sheer body of research published every year can be overwheiming-trom breakthroughs in .... READ FULL STORY Two keys to a stronger chemical assessment program: Planning for success and avoiding pitfalls by Nancy. Beck. Ph D. D.A.S.T. on OCTOBER 14. 2014 in INDUSTEY This week's Integrated Risk information System (IRIS) workshop on the National Research Council's (NRC) recommendations for improving federal chemical assessments gives the U.S. Environmental Protection Agency (EPA) an opportunily to build on the progress it has already made in creating a sound, more transparent, and objective assessment program. While the agenda for the workshop covers READ FULL STORY What are the key challenges for improving risk sessments? Two experts weigh in by Nancy Beak. Ph.D. on MAYA, 2014 in POLICY Two recurring themes at the 53rd meeting of the Society of Toxicology (SOT) in Phoenix, Arizona, were enhancing strategies for risk assessment and finding new ways to conduct safety assessments. Here are three questions (and some potential answers) that continue to drive the debate. What are the biggest issues for the future of risk assessment? READ FULL STORY / a Next BLOGROLL TRENDING ELEMENTS Source: https://www.industrydocuments.ucsf.edu/docs/gzbn0226 ACC's Principles for Improving Chemical Hazard and Risk Assessments Assessments should focus on understanding the inherent properties of substances in order to determine the likelihood of harm from a specific exposure. The public, businesses and regulators look to government Design assessments for reliable information about the potential hazards and risks associated with chemicals. Identify Key Science Issues Use Modern Science and Tools Prior to Initiation of Assessment Use relevant data Discuss the purpose, scope and technical approaches Consider how chemicals act in the body I Engage stakeholders Evaluate chemicals at relevant exposure levels Data and Methods Apply Objective Criteria Integrate Evidence Develop and apply consistent criteria for selecting Give the greatest weight to information from the and evaluating a study, before an assessment begins highest-quality and most-relevant studies Evaluate all studies to determine their quality, Transparently and objectively integrate evidence relevance and reliability to make realistic determinations of hazards and risks; consider all types of evidence Ensure Assessments Characterize Hazards and are Transparent Risks Fully and Accurately Communication Disclose key information and assumptions used Present hazards and risks in an easy-to- understand to develop assessments and reach conclusions manner to stakeholders and risk managers Make materials, including important data sets, Present a range of plausible values, including publicly available central estimates when going beyond a screening level assessment Conduct Scientific Peer Review by Improve Accountability O Independent Experts Use an independent accountability procedure to Ensure peer reviewers are fully independent from the verify that revised assessments are accurate program office issuing the assessment and responsive to scientific and peer review Review and Evaluate peer review panels for conflicts of interest; ensure panels contain a balance of perspectives and appropriate technical expertise RESULT. Public Trust in High-Quality Risk Assessment Source: https://www.industrydocuments.ucsf.edu/docs/gzbn0226 Formaldehyde Assessments Must Properly Evaluate and Integrate All Available Evidence Data and A fully integrated chemical assessment requires that all available scientific Methods evidence is evaluated for quality and relevance, then analyzed together to make an informed decision. Mechanistic Data WHAT THE is Animal Data SCIENCE TELLS US: (Studies about what a chemical does (Experimental data from in the human body and how it does it) animal lab studies) When integrating the three Compelling evidence shows that types of evidence, it is clear The best-available studies show inhaled formaldehyde does not that the data do not support a that inhaled formaldehyde has no reach bone marrow (Swenberg relationship between inhaled effect on blood or bone marrow. et al. 2011). formaldehyde and leukemia A recent NTP study on two There are no reliable, in humans. strains of mice genetically high-quality mechanistic data predisposed to develop leukemia available to support speculation to high doses of inhaled that formaldehyde causes formaldehyde and confirmed no leukemia. leukemia effects. Epidemiological Data (Studies of select human populations) Extensive and detailed critical reviews of epidemiological literature do not support a causal relationship between formaldehyde exposure and leukemia. When data from three large, high-quality studies are combined, the number of leukemia cases in the studied occupationally-exposed populations is essentially the same as what is expected in the U.S. population (152 v. 153), indicating there is no appreciable risk for developing leukemia. Source: https://www.industrydocuments.ucsf.edu/docs/gzbn0226 American Chemistry Council AMERICAN CHEMISTRY MATTERS A Blog of the American Chemistry Council Driving Innovation, Creating Jobs and Enhancing Safety Matters Elements Contributors Archives Contact About Take Action ACC Newsroom Members f n Returning to fundamental principles can help science LATEST TAGS live up to the public trust On the road with #ACCaugust 3.0 by Nancy Beck. Ph D. D.A.B.T. on NOVEMBER 24. 2014 in POUSY AUGUST 25, 2017 f Facebook Chemical industry prepared for new storm Linkedin 2 heading to U.S. guli coast AUGUST 24, 2017 Issues around listing chemicals under Prop A revised approach in the biomedical sciences for reporting research should set a strong precedent for 65 researchers, publishers, and regulators around the U.S. who are committed to improving the science that AUGUST 8, 2017 guides public health decisions. Scientists today are more prolific than ever. The sheer body of research published every year can be breakthroughs in innovation, to new health and safety studies, to novel solutions to improve environmental health. If there is one thing that should ground them all in the public trust, it should be a commitment to adhering to an established sound scientific process. Search Q Unfortunately, many of the scientific studies we read about in the news were not quite ready for prime time. Forbes contributor Geoffrey Kabat wrote in a November 15 piece that often il is the "anomalous, and almost certainly wrong, results" that can get the most attention. As Kabat points out, these inconsistent results can PREVIOUS POSTS have serious ramifications for public health: Previous Posts Select Month 66 This phenomenon leads to an enormous waste of resources, which comes at the expense of research that might actually lead to saving lives. it also confisses the public and leads people to mistrust science generally. Many in the scientific community agree, and at least one group of editors has already begun to lead a return to the fundamental principles of science to restore public confidence. Journals stand up for science "Reproducibility, rigor, transparency, and independent verification are comerstones of the scientific method," Editor-in-Chief Marcia McNutt made clear at the opening of a November 7 editorial published in the journal Science. According to McNutt, a swath of aditors from more than 30 major journals, together with funding agencies and other scientific leaders met at the American Association for the Advancement of Science headquarters sartier this year to tackie the reproducibility issue plaguing so many prectinical studies of late. Below is a list of guidelines they agreed to as first big step toward improving the integrity of the biomedical sciences: Journais should make il clear to authors the policies for statistical analysis and how they review the statistical accuracy of work under consideration Source: https://www.industrydocuments.ucsf.edu/docs/gzbn0226 Any imposed page limits should not discourage reproducibility (in other words, researchers should be given the time and space to show their work) Researchers should use a checklist to ensure the reporting of important experimental parameters: standards used, number and type of replicates, statistics, method of randomization, whether experimenters were blind to the conduct of the experiment, how the sample size was determined, and what criteria were used to include or exclude any data Journals should recommend that data be placed in public repositories, where available, and linked to the paper to ensure proper attribution Journals should ensure that all datasets relied upon for conclusions in the paper are made available upon request, where ethically appropriate, by editors and reviewers; in addition, journals should encourage the release of data for sharing after publication Once a journal publishes a paper, it should assume the obligation to consider publication of a refutation of that paper, subject to its usual standards of quality Journals should consider establishing best practices guidelines for images and biological material use. Valuable tessons for Improving chemical assessments Because of their fundamental nature, the guidelines have tremendous potential to help the public beyond their use by journals and beyond the biomedical science field. For example, many of the guidelines proposed in McNutt's editorial are consistent with the recommendations that have been recently offered to improve how federal programs are evaluating chemicals. For example, there are many parallels when it comes to improving the review and transparency of the research used in chemical assessment programs. in several cases, these concepts are in line with ACC's principles for enhancing federal risk assessment, especially when it comes to evaluating data and selecting studies used in assessments and providing full disclosure of underlying data and key information used to develop assessments. Fully implementing these improvements to chemical assessments will provide regulators, the public, and industry with more accurate and useful information to help guide better decisions for protecting human health and the environment. Call to action Now that leaders in the biomedical sciences have acknowledged that their journals may not always meet scientific standards of reproducibility, rigor, transparency and independent verification, it's time that researchers and journals that examine chemicals do the same. The American Association for the Advancement of Science (AAAS) pledge should serve as a wake-up call to researchers and journals across the toxicological sciences to step up their game by renewing their commitment to the scientific method. And regulators can help facilitate this "return to the science" by rigorously reviewing existing published studies to ensure they meet these core tenels of the scientific method and calling on journals to publish more robust, independently verified studies going forward, As McNutt concludes, "The hope is that these guidelines will not be viewed as onerous, but as part of the quality control that justifies the public trust in science." S Facebook Linkedin American Association for the Adyanosment of Sciance. Chamical Assessment, Kabat, Marcia McNutt. Risk. Safety NANOSAFE 2014 conference in France features paper aconsored by ACC's Panal Versatile, Durable. incendible Macy's Thankegiving Day Parade Balloons! Source: https://www.industrydocuments.ucsf.edu/docs/gzbn0226

What is the invoice number for this invoice?

ymph0227

ymph0227_p0

1338., 1338

AMherst 6-1697 AComa 2-7011 ADVERTISING E SPLAY CO. = 1200 LAWRENCE S DENVER, COLORADO-80204 - INVOICE NO. 1338 PLEASE SHOW OUR INVOICE NUMBER WHEN MAKING PAYMENT Great Western Sugar Company % Mr. Jim Lyon 1530 16th St. YOUR ORDER-NO Jim Lyon Denver, Colo 80202 DATE Oct. 16, 1968 QUANTITY DESCRIPTION PRICE AMOUNT 1 60 x 90" floor display "THEN & NOW 189.00 1 mounted organizational chart 36 x 84 16.00 1 hemmed velvet background display 17.00 222.00 OK. - Justines Anyon NONTAXABLE LABOR A/c 1-96-307-15-35 PLEASE MAKE PAYMENT FROM THIS INVOICE - NO STATEMENT WILL BE MAILED A quantity variation of 10 per cent either way on all orders, is understood as filling the order, and is to be paid for proportionately. All claims against this BILL MUST be mode immediately on receipt of goods. All agreements contingent upon strikes, accidents, transportation delays and other causes beyond our control. Eight per cent interest will be charged past due accounts after 60 days. Source: :ttps://www.industrydocuments.ucsf.edu/docs/ymph0227

What date was the invoice issued on?

ymph0227

ymph0227_p0

OCT. 16, 1968, Oct. 16, 1968.

AMherst 6-1697 AComa 2-7011 ADVERTISING E SPLAY CO. = 1200 LAWRENCE S DENVER, COLORADO-80204 - INVOICE NO. 1338 PLEASE SHOW OUR INVOICE NUMBER WHEN MAKING PAYMENT Great Western Sugar Company % Mr. Jim Lyon 1530 16th St. YOUR ORDER-NO Jim Lyon Denver, Colo 80202 DATE Oct. 16, 1968 QUANTITY DESCRIPTION PRICE AMOUNT 1 60 x 90" floor display "THEN & NOW 189.00 1 mounted organizational chart 36 x 84 16.00 1 hemmed velvet background display 17.00 222.00 OK. - Justines Anyon NONTAXABLE LABOR A/c 1-96-307-15-35 PLEASE MAKE PAYMENT FROM THIS INVOICE - NO STATEMENT WILL BE MAILED A quantity variation of 10 per cent either way on all orders, is understood as filling the order, and is to be paid for proportionately. All claims against this BILL MUST be mode immediately on receipt of goods. All agreements contingent upon strikes, accidents, transportation delays and other causes beyond our control. Eight per cent interest will be charged past due accounts after 60 days. Source: :ttps://www.industrydocuments.ucsf.edu/docs/ymph0227

What is the total amount in the invoice?

ymph0227

ymph0227_p0

222, 222 00

AMherst 6-1697 AComa 2-7011 ADVERTISING E SPLAY CO. = 1200 LAWRENCE S DENVER, COLORADO-80204 - INVOICE NO. 1338 PLEASE SHOW OUR INVOICE NUMBER WHEN MAKING PAYMENT Great Western Sugar Company % Mr. Jim Lyon 1530 16th St. YOUR ORDER-NO Jim Lyon Denver, Colo 80202 DATE Oct. 16, 1968 QUANTITY DESCRIPTION PRICE AMOUNT 1 60 x 90" floor display "THEN & NOW 189.00 1 mounted organizational chart 36 x 84 16.00 1 hemmed velvet background display 17.00 222.00 OK. - Justines Anyon NONTAXABLE LABOR A/c 1-96-307-15-35 PLEASE MAKE PAYMENT FROM THIS INVOICE - NO STATEMENT WILL BE MAILED A quantity variation of 10 per cent either way on all orders, is understood as filling the order, and is to be paid for proportionately. All claims against this BILL MUST be mode immediately on receipt of goods. All agreements contingent upon strikes, accidents, transportation delays and other causes beyond our control. Eight per cent interest will be charged past due accounts after 60 days. Source: :ttps://www.industrydocuments.ucsf.edu/docs/ymph0227

Where is the Great Western Sugar Company located?

ppnh0227

ppnh0227_p0, ppnh0227_p1, ppnh0227_p2, ppnh0227_p3, ppnh0227_p4, ppnh0227_p5, ppnh0227_p6, ppnh0227_p7, ppnh0227_p8, ppnh0227_p9

Denver, Colorado., DENVER, COLORADO

FREE OFFER 12-8-70 FULL COLOR RECIPE SET. A "Good Wishes" offer for you from G W Sugar. Mail coupon today! MRS HELEN MARUSKA (NAME . PLEASE PRINT) 115 SOUTH FOREST AVE (ADDRESS) PALATINE ILLINGIS 60067 (CITY) (STATE) (ZIP CODE) Mail to: Great Western Sugar Company Sales Department Room 514 FREE OFFER FULL COLOR RECIPE SET. A "Good Wishes" offer for you from G W Sugar. Mail coupon today! mrs. Julia (NAME PLEASE Stevens PRINT) . 1227 - 5th avenue SE (ADDRESS) Cedar (CITY) Rapids bowa (STATE) 52403 (ZIP CODE) Mail to: Great Western Sugar Company Sales Department Room 514 Box 5308 Denver, Colorado 80217 Source: Ittps:llwww.industrydocuments.ucsf.edu/docs/ppnh0227_ FREE OFFER FULL COLOR RECIPE SET. A "Good Wishes" offer for you from G W Sugar. Mail coupon today! Mrs a J (NAME Schauer . PLEASE PRINT) 3010- - games (ADDRESS) are no. minneapolis (CITY) minn (STATE) 55411 (ZIP CODE) Mail to: Great Western Sugar Company Sales Department Room 514 Box 5308 Denver, Colorado 80217 ucst FREE OFFER FULL COLOR RECIPE SET. A "Good Wishes" offer for you froi G W Sugar. Mail coupon today! Rachel E mc Daniel (NAME . PLEASE PRINT) R R I attica (ADDRESS) 1 tans 67009 (CITY) (STATE) (ZIP CODE) Mail to: Great Western Sugar Company Sales Department Room 514 Box 5308 Denver, Colorado 80217 Source: https:lwww.industrydocuments.ucsf edu/docs/nonh0227 FREE OFF FULL COLOR RECIPE SET. A "Good Wishes" offer for you from G W Sugar. Mail coupon today! WM STORMA (NAME . PLEASE PRINT) 11527 garfaed (ADDRESS) are WAUWATOSA wis 53226 (CITY) (STATE) (ZIP CODE) Mail to: Great Western Sugar Company Sales Department Room 514 Box 5308 Denver, Colorado 80217 Source: https://wwvw.industrydocuments.ucsf.edu/docs/ppnh0227 FREE OFFER FULL COLOR RECIPE SET. A "Good Wishes" offer for you from G W Sugar. Mail coupon today! FLORENCE 0208A0 CZEKAJ (NAME . PLEASE PRINT) 2720 N MEADI (ADDRESS) CHICAGO 101 60639 (CITY) (STATE) (ZIP CODE) Mail to: Great Western Sugar Company Sales Department Room 514 Sou Box 5308 Colorado 80217nts.ucsf.edu/docs/ppnh0227 FREE OFFER to FULL COLQR RECIPE SET. A "Good Wishes" offer for you from G W Sugar: Mail coupon today! 02.1 HELEA C2ADD A. (NAME - PLEASE PRINT) 2841 Wrst DUNBAR LACE (ADDRESS) MILWAUNIEE Wissers A 53208 (CITY) (STATE) (ZIP CODE) Mail to: Great Western Sugar Company Sales Department Room 514 Box 5308 Denver, Colorado 80217 Source: Thttps://www.industrydocuments.ucsf.edu/docs/ppnh0227 FREE OFFER FULL COLOR RECIPE SET. A "Good Wishes" offer for you from G W Sugar. Mail coupon today! Mrs - H Jokestead (NAME . PLEASE PRINT) 3026 Lyndale (ADDRESS) Ave North Minneapolis Minneso (STATE) TE 55411 (ZIP (CITY) CODE) Mall to: Great Western Sugar Company Sales Department Room 514 Box 5308 Denver, Colorado 80217 Source: ppnh0227 FREE OFFER FULL COLOR RECIPE SET. A "Good Wishes" offer for you from G W Sugar. Mail coupon today! h. WILLMS (NAME . PLEASE PRINT) 2541 So, 13 th st. (ADDRESS) Mihwautee WIS 53215 (CITY) (STATE) (ZIP CODE) Mail to: Great Western Sugar Company Sales Department Room 514 Pax 5308 Denver, Colorado 80217 Source: https://www.industrydocuments.ucsf.edu/docs/ppnh0227 alas FREE OFFER FULL COLOR RECIPE SET. A "Good Wishes" offer for you from Racey Mrs newbirk G W Sugar. Mail coupon today! Margent (NAME . PLEASE PRINT) 315 -4th LIVE (ADDRESS) Baraboo Wisconsin52913 (CITY) (STATE) (ZIP CODE) Mail to: Great Western Sugar Company Sales Department Room 514 Box 5308 Denver, Colorado 80217 B NET WT. 5 sk POUNDS Source: https://www.industrydocuments.ucsf.edu/docs/ppnh0227

Where was the Phoenix Musical Theatre Guild's annual holiday luncheon held?

jgmk0226

jgmk0226_p0, jgmk0226_p1, jgmk0226_p2, jgmk0226_p3

Phoenix Country Club, Phoenix Country Club., at the Phoenix Country Club

Christmas Cookie Caper A cast of thousands (of cookies) will star at the Phoenix Musical Theatre Guild's annual holiday luncheon. Home-baked by members, there will be enough cookies for sale to keep everyone out of the kitchen this year. In supporting roles will be a Cookie Calendar Cookbook, decorated Snowmen Cookie Jars and green and blue net aprons adorned with sequined notes, all for sale to benefit the annual scholar- ships sponsored by PMTG. The luncheon will be held at noon Dec. 10 at the Phoenix Country Club. Reser- vations must be made by Dec. 8 with Mrs. Robert Garrett, Mrs. Henry Farb- er, or Mrs. Robert Tillier. A recipe preview of the cast of cookies is on an inside page. Wednesday, December 3, 1975 THE ARIZONA REPUBLIC food Mrs. Gerald Hafleigh, left, Mrs. Robert Parker and Mrs. Henry Farber check out the cast of cookies and supernumerary Christmas crafts for Phoenix Musical Theater Guild's annual holiday luncheon. SECTION Repobilic Phote by Roy Cosway By DOROTHEE POLSON Republic Food Editer Food and nutrition information- --- Crisis! Capsule comments from a recent symposium on this topic appear here, with pictures of the speak- ers. More complete reports follow on inside pages. BARRETT: "The word 'natural' has replaced sex appeal as the magic sales word of the decade. "Public confusion about nutrition lies with the TV talk shows, a stage for charlatans, and with television advertising, and more shamefully, with doctors who prescribe vitamins for fatigue. depression and nervousness, rather than to take the time to find out what is the matter with the patient. "The Merv Griffin show is a travesty when it comes to nutrition. It is an unbalanced force, an irresponsible power in the JUKES: media, presenting (self-styled nutritionists) who are very good Stephen Barrett, M.D. (psychiatry) showmen, but NOT nutritionists.' "A prominent source of MIS-information about nutrition is the Private practice health food store, selling items like organic foods, rutin, ganga, Staff psychiatrist, Allentown (Pa.) State Hospital pangamic acid, rose hips, vitamin 17s, which have no nutritional value. and Muhlenburg Medical Center "There is NO difference between synthetic and natural vita- mins except price. The entire adult daily allowance for 10 vitamins can be supplied in bulk form for 50 cents per person per year. There is no need for vitamin deficiency (and no need for) megavitamins, which are (merely) high profit items. WHITE: "Most diet books - are nutritionally immoral. "The trouble is with the first amendment to the Constitution, the one that guarantees freedom of expression and freedom of Thomas H. Jukes, Ph.D, (biochemistry) D.Sc. speech. The books are bad enough in themselves, but the Professor, Medical Physies advertising and promotion for them is usually despicable. Lecturer, Nutritional Sciences "Diet books are a multi-million dollar business because University of California (Berkeley) the public is hungry for quick and easy solutions for (weight) problems. Publishers know this and capitalize on it." Inside Dorothee's Pot au Feu: The children were home for Thanksgiving; they left with the leftovers Philip L. White, D.Sc. Secretary, Council on Food and Nutrition Laveen Cowbelles Christmas House is Saturday Director, Foods and Nutrition Department Gompers tots learn all about tacos American Medical Association (Chieago) Friends of Mexican Art serve Mexican coffee and cookies Minnesota author writes a historical cookbook , - K-2 The Arizona Republie Phoenix, Wed.,Dec.3,1975 ONE CALL DOES IT ALL Information crisis' revealed "CHARGE-IT" BEEF SALE NO PAYMENT TILL JANUARY 5 NEXT YEAR! The times have Food and in 90 DAYS, SAME AS CASH 3 EQUAL PAYMENTS Crisis!, was people together, cently by the Sugar As- creating a competitive 'Scientists won't promise to cure Put BEEF Back In PRICES EFFECTIVE sociation, Inc. spirit. If they are properly FOOD advised by a good nutri- arthritis or cancer; but 'health' THRU WEDNESDAY J W. Tatem Jr., presi- dent of the association, tion consultant they can food people do make such claims, promises' introduced the panel of helpful. Your Budget! DEC. 10th STAMPS ACCEPTED three scientists and White: If people are added: going to count calories BABY BEEF (1)USDA CHOICE one's peers agree with the Jukes: Part of the prob- viding scholarships and information? lem is that the scientific fellowships to enhance SPECIAL BABY BEEF Moderator: (Tatem): story is a dull one. We this; a great deal is going USDA INSPECTED Any scientist associated can't promise people 20 on. 200-300 Lbs. USDA CHOICE Avg. Wt. with industry is immedi- years more of life, or how COMMENT ON "Nutrition information ately. suspect, so many to cure arthritis or can- HYPERKINESIS? 59e BEEF HALF 200-300 Lb. 86 Lb. scientists prefer to go cer. But the "health" food Lb. Plus Rib Section Cutting and wrapping free. Subject to all has been taken over by back to their labs and people do. Reliable infor- Barrett: Far too many cutting and trimloss. opportunists promoting mation is available people are called hyperac- Cutting and wrapping write theses. Fred Stare, free. Subject to all out- M.D. is dedicated scien- through the FDA, AMA, tive than should be. 84e (2) USDA GOOD ting and frim loss. questionable, harmful products' Lb. tist, he speaks his own American Institute of White: Another (talk opinions, and nobody Nutrition, American Soci- show book) tragedy. Even Cutting and wrap- BABY BEEF BABY BEEF ping free. Subject elses. Many (faddists) ety of Clinical Nutrition, the title "Why Your Child to all cutting and disagree with him, be- American Pediatric As- is Hyperactive" is sensa- HIND QUARTERS frim loss. Avg. Wt. cause they don't under- sociation. itionalized. 200-300 Lb. 84°. stand the medical imput (Sold in Two's Only) GUARANTEED TO SATISFY. IF NOT Cutting and wrapping free. Subject to all of what Fred has to say. COMPLETELY SATISFIED, RETURN cuffing and trim loss. "Information about they should learn the rela- His newspaper columns nutrition has drifted away tionship between the serv- tell the truth - they don't Avg Wt. WITHIN FIVE DAYS & YOUR ORDER from the medical and 175-200 Lbs. WILL BE REPLACED ON AMOUNT RE- (3) USDA CHOICE ing sizes of foods and the promise you everlasting Television has unbalanced Lb. TURNED. scientific community to calories. First, be sure life. RIBS & CHUCKS the laymen, including a your diet is a good one; nutrition information in Cutting and wrapping free. Subject to all - goodly number of oppor- then, eat smaller por- Jukes: In some cases a terrible way' outting and trim loss. FREE! Seef. Boneloss 800 ribs soup bone Liver. Steak Chuck tunists, promoting ques- tions. It is the amount of the reason for dropping Avg. Wt. 300 400 Lb. tionable and often harm- food you eat, the total Dr. Stare's column has USDA CHOICE 50 Pcs. Pork Chops Cuffing and wrap- ful products,' he said. calories that is important. been an organized write- Or ping free. Subject 15 Lbs. Fryers to all cutting and 69° "Fortunately, there has SHOULD NEWSPAPERS in in behalf of the organic BEEF HALF frim loss. been a backlash, and now PUBLISH THE FAD- food movement. ARE MEDICAL DOC. With purchase of 1/2 beef or more the scientific community DISTS' VIEW? TORS TRAINED IN USDA CHOICE WHY DOESN'T SCIENCE KEN'S MARKET is directing itself to re- Barrett: No. There is no NUTRITION? Avg. Wt. C storing crucial respon- balance Television GET ITS now. MESSAGE 3216 E. Camelback Rd. White: All physicians 300-350 lb. 1/2 HOG HEAVY BEEF sibility to those with are given some exposure Lb. professional credentials. to nutrition, although it featuring Oufting and wrapping free. Subject to all Contains: Ham, bacon, pork chops, pork Net may not be labeled as EASTERN VEAL After giving their pre- cufting and trim loss. steak, spare ribs, picnic ham, country EASTERN PORK back bones, pork roast sausage. BEEF 2 lbs. Weight $599 such. They have basic pared talks, the three speakers answered ques- 'An organized write-in science courses in bio- tions, among them, the chemistry, physiology, USDA GOOD Avg. wf. by organic food movement USDA AMERICAN 100-125 lbs. 129 Cutting and wrapping free. Subject to all Lb. cutting and trimlloss. pharmacology and all the following: stopped Dr. Stare column' way through their train- CHOICE LAMB BEEF HALF All Cutting And Wrapping Free. Subject DO CALORIES COUNT? USDA CHOICE To All Cutting And Trim Losses. Prime Beef Half ing they are given infor- DO DIET CLUBS HELP? mation that relates nutri- EASTERN BEEF ents to body processes. FILETS Black Angus Beef Half $1 Barrett: "For every What they may be miss. Avg, Wt. 3,500 calorie deficiency ing is an impressionable Check with KEN'S for 300-500 Lb. you will lose pound. So has unbalanced things in ACROSS LIKE THE FAD- your locker Beef cut, 6 Oz. 99e each Swift Premium Beef Half 99°L Lb. course that relates foods eat less. Weight reduction a terrible way. DISTS DO? Swift Proten Beef Half 99°Lb. to nutrients. AMA is pro- wrapped, quick frozen WHO CAN WE BELIEVE Barrett: Part of the Cutting and wrapping free. Subject to all - - to your specifications. cutting and frim loss. 8 Oz. each Cutting and wrapping free. Subject AND TRUST? problem is that there is cufting and trim loss. money involved. The EGG NOG White: It seems the For the hard to buy gift 2 BIG LOCATIONS TO SERVE YOU "health" food industry, ICE CREAM FREE 10 Lbs. Fryers or same three or four nutri- the book publishers. They name nearest for Christmas -give a SUPERIOR MEATS 25 Pos. Pork Chops tionists are always asked With orders 'In dieting, stand to gain a tremen- dealer coll for: quotation to counter- locker beef! dous amount of money by 1826 W. PEORIA - 944-9601 it is total balance misinformation. 254-5353 CALL NOW publicizing what they do. 2205 N. COUNTRY CLUB DR., MESA 834-9810 834-9810 There is a tendency 955-0360 FIRANOE ONAROES WITN calories that People who speak out overuse these three or APPROVED CREDIT ONLY . HOURS 9-6:30, SAT. CLOSED SUN. 994-9601 against health mis-infor- are important four people. Part of the mation are not funded. problem is the number of The "health" food indus- our consultants used is try involves maybe Tily CREAM too small. An important 40 .000 people working full qualification of trust: Do time. Chris Evert serves Introducing New the new slice Fruity Freakies' Cereal for your kids. BORDEN Pro-line SKIM- New Fruity Freakies is a crunchy, fruit flavored cereal your kids will love to eat. And since we're giving AMERICAN you 15c off, it's a crunchy, fruit TM flavored cereal you'll love to try. SLICES PASTEURIZED PROCESS CHEESE PRODUCT 15% MILK FAT And 15c off for you. Half the fat. All the flavor. Fantastic. - - - - - STORE COUPON B5520-5 10 off new Borden Skim-American Slices. 10% 15c OFF ON FRUITY 15c FREAKIES CEREAL 15c OFF OFF 15c 15c STORE COUPON I r Pheenix, Wed., Dec. The Arizona Republie K-3) Satisfy your animal desires Scientists warn against alarmists for 7c less. Not long ago, cat like you had to pay full price for a can of Kitty Salmon. But now, the lucky cat who uses this special coupon can satisfy his desire for salmon with much less capital. More about the nutri- is published in the Ameri- could tell the truth on his tion seminar speakers *National Health Federation and who cannot. Kitty Salmon Dinners come in four different lip- can Medical Association's program, the producer smacking varieties, and every one of them is less with photographed on the cover promotes pseudo-science, quackery' monthly magazine, did not reply.' He also urged fluorida- this lucky cat coupon. page: "Today's Health," ticked tion, and said a campaign So romp on down to your favorite grocery and get your off these points: The psychiatrist urged is underway to discredit it Kitty Salmon today! THOMAS JUKES, D. columns called "Instead by the National Health HE QUOTED a New about "so-called hypo- Sc., is a pioneer in the -In his first diet book of field of vitamins and is glycemia and the special Examples: In- Federation, an organiza- York survey of organic author Irvin Stillman diets suggested for it." stead of taking vitamins, tion he describes as also involved in the space foods from health stores. damned carbohydrates; in learn to eat wisely. In- "promoters and victims program for detecting life A chemical analysis re- FOOD ADDITIVES? his next one he praises stead of fad diets, learn to pseudo-science, on Mars. vealed about 30 per cent them. Will the sequel be count calories. Instead of- promoting quackery and Jukes said: "I got into had detectable levels of "They are as diverse as "The Son of Stillman believing everybody, so-called "health' products food itself," Jukes said. Shuns Starches?" the space program pri- pesticide residues (at learn who can be trusted with false claims.' "You must say which one you mean. The problem of "AMA condemned low-carbohydrate food poisoning does not There are more toxic substances arise from food additives, diets; the publicity increased but from bacterial con- at higher levels naturally present tamination. in foods than are added as additives' book sales by 65% "The interesting thing about food additives is -The AMA's Council that they cause so much marily because of my in- on Nutrition condemned harmless levels) but fmental problems' (worry). Actually there low carbohydrate diets. LETTUCE 5:51 terest in molecular evolu- they were advertised as tion and the origin of life, The publicity increased organic, not containing are more toxic substances but became more and any pesticides. at higher levels naturally book sales by 65 per cent. more involved with nutri- present in foods than are -Nearly all popular APPLES 8:51 tional matters." diet books take consider- 7c 7c A similar check of non- added in the form of addi- organic foods from super- tives,' he said. able liberty with the truth He scored the "stop when developing the ratio- BROCCOLI ONIONS TURNIPS markets showed about 25 feeding grain to cattle' He used mercury found nale for a given diet. In per cent had pesticide controversy as "oversim- in swordfish and tuna as others, one finds some residues (harmless an example. very strange bio-chemical 7:51 10°. 10° Killy levels). SALMON "FEED grains fed to In another health food The diet industry accounts for livestock are not accept- CABBAGE 7. 7C off when you buy any can of Kitty Cat Food. store Jukes said he saw able to the consumer as a 1% of our Gross National Product' Mr. brown rice in two sacks, .direct source of food,' Jukes said. Example: one labeled ordinary; the other, organic, and priced "SWORDFISH was ban- or psysiological explana- Limit twice as much as the ned because of mercury tion of metabolism. FARM 2-U Daily 9-8 Corn is deficient in pro- Reserved Closed tein and other nutrients; content; then it was real- Sunday first. Chemical analysis Stephen Barrett, M.D., I caftle eat not just the showed both were identi- ized that the mercury was appealed to the press to 2 Blocks West of the - - grain part but the cobs naturally present in sea 26th Ave. & Glendale cal. help balance the flood of Black Canyon Freeway and stalks, as well as water and always has A product England Fish Company nutritional misinforma- other roughage that can- been. More research not be consumed by The answer was that tion, especially that from showed there was another television. humans; then they con- the bottom had fallen out element in sea water, se- vert it into meat. of the organic rice mar- lenium, which detoxified Referring to Merv Grif- fin show guests such as Linus Pauling, Carlton He said he often goes to check health 'Health' food stores are Fredericks, the late Adele on food Davis, Roger Williams, stores, prominent prominent sources of nisinformation John Yudkin Rodale source of misinforma- magazines, and others, as tion. "the health food industry ket, so they were having mercury, so that the fish selling its bill of goods," PEPPERIOGE FARM A fellow professor of his to sell it as regular rice, were safe, after all," he Barrett said: checked a sale of alfalfa but were still selling said. "When the National seeds, found among them whatever they could at The diet industry ac- Nutrition twice the price. Consortium a considerable percentage counts for one per cent of of morning glory seeds. Jukes also our Gross National Prod- asked Griffin's producer warned for equal time, so that re- uct. I guess that means sponsibile nutritionists that we spend more than $100 billion on food and $10 billion recovering Food poisoning Feed grains for cattle from its effects," said comes from are not the kind that can be Philip White, Ph.D., at contamination, consumed by humans' the nutrition symposium. not additives' White, whose monthly column, "Smart Eating," Save $1.00 with Nescafé Get savings up to 75c with valuable coupons inside specially marked jars of Nescafé" Instant Coffee. Save 10c on 24-oz. bottle of Welch's GrapeJuice 10c on Quaker* Puffed Cereal, 20c on two Stouffer's* Crumb Cakes, 10c on Armour Treet", /Hash, 10c on 11-Oz. jar of Pream; and 15c on Handi-Wipes* cloths. Save 25c on Nescate too. Clip the coupon below and get 25c off Nescalé* Instant Coffee. R Puiffed Rice vanilla ice cream. Maybe both! NESCAFE Remember the smell of apple pie baking? Crumb Pepperidge Farm remembers. And brings you apple pie tarts, with GRAPE JUICE cinnamon, hazelnuts and a ROTHBERG sprinkling of raisins. 10ç Save 25€ PEPPERIOGE FARM. 10ç Save 100 on 1 box of Apple, Bluebenr, Ona 10-oz.jarof Nescafé" Instant Coffee, Cherry, Lemon, Apple Strawbenry or Pineapple Pie Tarts. 10ç STORE In your 104 6405-7 K-4 The Arizona Republic Phoenix, Wed., Dee. 3, 1975 Collectors' cook-shelf Food on the Frontier' "FOOD ON THE seasons. Most from mem- of zucchini, and lower- FRONTIER" by Marjorie bers; some from Chicago cost soybeans were used Kreidberg (published by restaurants. Order by to provide the family with Author cooks for book the Minnesota Historical writing to the league at protein. Such recipes as Society, 275 recipes, $6.50 1447 N. Aster St., Chicago, Zucchini Quiche and Soy- paperback). In addition to III. 60610. beans Ole. the recipes are some 200 "CUTTING UP IN THE pages of the cooking prob- "LAROUSSE TREAS- The Minnesota author of fascinating new historical revelaing the horrendous conditions under which these KITCHEN" by Merle lems of pioneer women URY OF COUNTRY cookbook spent Thansgiving visiting Scottsdale rela- Ellis (Chronicle Books, women worked -with no complaints. (talk about shortages, COOKING" by the editors tives. $5.95, paperback). Tools adulterated foods, primi- of Librairie Larousse Ten years of research and writing later, Mrs. Kreid- and tricks of the meat The author, Mrs. Irving (Marjorie) Kreidberg, and tive utensils, lack of (Crown Publishers, berg's intriguing historical recount, together with re- trade, as well as a diction- her husband visited her mother, Mrs. Gilbert A. Helz- cipes she herself tested and updated, is complete. money and such depriva- $12.95). Four hundred and ary of beef terms, carv- berg, formerly of Kansas City, and sister and brother- tions as grasshoppers!) fifty recipes for country in-law, Mr. and Mrs. Harold D. Rosoff. Rosoff is vice Curiously, the recipes are not at all ethnic, but Also 100 sketchs of old- ing, preserving, freezing style cookery from not president of food management for the Greyhound Cor- typical to any frontier. "It seems in those days the fashioned cooking para- and how to cut up your just French provinces, pioneers were trying to lose their foreign image, to meat. poration. phernalia and kitchen in- but 50 other countries. assimilate, even through cooking, with America,' the teriors. order send "ZUCCHINI COOK- Many aimed at economy. Mrs. Kreidberg's book, "Food on the Frontier" (see author said. check to MHS Order BOOK" and "SOYBEAN it listed in today's Collectors' Cook-shelf) is the result "COOK AHEAD COOK- "I HOPE THE book will generate more old books, Dept., 1500 Mississippi COOKERY' by Joanne of 10 years of work. ERY" by Theodora Zavin and letters and ethnic recipes to the historical society,' St., St. Paul, Minn. 55101, and Virg Lemley (Wilder- and Fredda Stuart "I WAS AN editorial assistant for the Minnesota she added. adding 50 cents for post- ness House, each, (Crown, $6.95). An enlarg- Historical Society, said Mrs. Kreidberg. "One day I went down two levels of the building and came across She and her husband are both graduates of the age. paperback). About 50 re- ed edition of "The Work- University of Minnesota's School of Journalism. He is "SOUPCON" (by the cipes in each of these lit- ing Wives Cookbook" with an immense collection of 19th century cookbooks. The now president of North Central Publishers. They have Junior League of Chicago, tle books, developed when all recipes based on more read, the more I learned about the hazards and two married sons, Gilbert, a stockbroker, and Roger Republic Photo Inc., .95 plus 65 cents her husband (an electron- preparation the night be- handicaps of homemaking on the frontier. (journalism graduate of Northwestern), who is on the Marjorie Kreidberg and her new book postage, paperback). ics engineer) lost his job fore, including a special "There was also a superb collection of old letters staff of Minnesota governor Wendell Anderson. "Food on the Frontier" More than 600 recipes ar- and her son (a 4-H gar- chapter on cooking for ranged according to the dener) had a bumper crop company. GOLD SUPER SAVINGS SUPER A.J.Bayless BOND Your Home Town Grocer" STAMP DISCOUNT EVERY DAY AT BAYLESS TIDE MILK DOUBLE CARNATION SEASONED Detergent GOLD BOND 49° All Jersey. Giant size. Low Fat. GREEN 49-0z. BOX. HALF GALLON 1e STAMPS PLUS ONE FILLED SUPER DISCOUNT BOOKLET. PLUS ONE FILLED SUPER DISCOUNT BOOKLET. BEANS GOOD DEC.2 thru DEC.8. GOOD DEC.2 thru DEC.8. WEDNESDAY DOLE BRAND. N° 303 CAN. 25 BEEF RAINBOW GROUND BONELESS SOLE TOP PRINGLE BEEF SIRLOIN CHIPS LIVER TROUT CHUCK FILLETS ROAST STEAK Fresh frozen young steer liver. Individually quick frozen. 100% pure Chuck meat. Flash frozen. Beef Chuck Boneless. TWIN PACK. Skin on. Solid pack. Cross Rib cut. Bayless Supreme Beef. 77° LB. 39° LB. $139 99° 89° LB. $169 LB. LB. $199 LB. 3-Oz.PKG. ITALIAN SAUSAGE links. Messina brand. Mild hot. $139 HORMEL WAFER BACON Sliced. Highly selected. Flash frozen. BORDEN'S SKIM. 12-Oz.PKG $139 OSCAR MAYER BOLOGNA Meat Beef 8-Oz. PKG 65° AMERICAN BAR-S BEEF FRANKS 1-L6.PKG 89° OSCAR MAYER BOLOGNA Meat Beef, 12-Oz.P 95e Individually sliced. 12-0z.PKG $119 BAR-S MEAT WIENERS 1-Lb. PKG 89° OSCAR MAYER MEATS variety 12-Oz.PKG $139 CANNED HAM Hormel. Boneless, fully cooked. 5-L6.SIZ $1049 DEL MONTE BROWN 'N SERVE REgular, Hot varieties. 8-Oz.PKG 93e CUBE BEEF STEAK Bayless Supreme Beef. LB $193 FRUIT COCKTAIL APPLES COLE SLAW Deluxe PKG. 19° N. 303 CAN Washington State Red Golden FRESH CARROTS 35 Delicious.Large Extra Fancy. 29° 2-LB. CELLO PKG WALNUTS 29° BABY LB. HORMEL PORK & GIANT PERCH CORNED BEANS FAB FILLETS BEEF VAN CAMP'S DETERGENT. 49 oz. BOX. TOP FROST-1-LB.PKG. 12 oz CAN 25° 97 89° 85 6001 N. 7th 210 E. DUNLAP 6131 N. 35th AVE. 8030 N. 27th AVE. 1617 5542 E. THOMAS 7141 E. LINCOLN 6529 W. INDIAN SCHOOL 2707 W. CAMELBACK 3205 McDOWELL 7007 7th 10620 N. 32nd ST. 4610 N. SCOTTSDALE 12606 N. BLACK CANYON *

When was the Phoenix Musical Theatre Guild's annual holiday luncheon held?

jgmk0226

jgmk0226_p0, jgmk0226_p1, jgmk0226_p2, jgmk0226_p3

At noon Dec.10, at noon Dec. 10

Christmas Cookie Caper A cast of thousands (of cookies) will star at the Phoenix Musical Theatre Guild's annual holiday luncheon. Home-baked by members, there will be enough cookies for sale to keep everyone out of the kitchen this year. In supporting roles will be a Cookie Calendar Cookbook, decorated Snowmen Cookie Jars and green and blue net aprons adorned with sequined notes, all for sale to benefit the annual scholar- ships sponsored by PMTG. The luncheon will be held at noon Dec. 10 at the Phoenix Country Club. Reser- vations must be made by Dec. 8 with Mrs. Robert Garrett, Mrs. Henry Farb- er, or Mrs. Robert Tillier. A recipe preview of the cast of cookies is on an inside page. Wednesday, December 3, 1975 THE ARIZONA REPUBLIC food Mrs. Gerald Hafleigh, left, Mrs. Robert Parker and Mrs. Henry Farber check out the cast of cookies and supernumerary Christmas crafts for Phoenix Musical Theater Guild's annual holiday luncheon. SECTION Repobilic Phote by Roy Cosway By DOROTHEE POLSON Republic Food Editer Food and nutrition information- --- Crisis! Capsule comments from a recent symposium on this topic appear here, with pictures of the speak- ers. More complete reports follow on inside pages. BARRETT: "The word 'natural' has replaced sex appeal as the magic sales word of the decade. "Public confusion about nutrition lies with the TV talk shows, a stage for charlatans, and with television advertising, and more shamefully, with doctors who prescribe vitamins for fatigue. depression and nervousness, rather than to take the time to find out what is the matter with the patient. "The Merv Griffin show is a travesty when it comes to nutrition. It is an unbalanced force, an irresponsible power in the JUKES: media, presenting (self-styled nutritionists) who are very good Stephen Barrett, M.D. (psychiatry) showmen, but NOT nutritionists.' "A prominent source of MIS-information about nutrition is the Private practice health food store, selling items like organic foods, rutin, ganga, Staff psychiatrist, Allentown (Pa.) State Hospital pangamic acid, rose hips, vitamin 17s, which have no nutritional value. and Muhlenburg Medical Center "There is NO difference between synthetic and natural vita- mins except price. The entire adult daily allowance for 10 vitamins can be supplied in bulk form for 50 cents per person per year. There is no need for vitamin deficiency (and no need for) megavitamins, which are (merely) high profit items. WHITE: "Most diet books - are nutritionally immoral. "The trouble is with the first amendment to the Constitution, the one that guarantees freedom of expression and freedom of Thomas H. Jukes, Ph.D, (biochemistry) D.Sc. speech. The books are bad enough in themselves, but the Professor, Medical Physies advertising and promotion for them is usually despicable. Lecturer, Nutritional Sciences "Diet books are a multi-million dollar business because University of California (Berkeley) the public is hungry for quick and easy solutions for (weight) problems. Publishers know this and capitalize on it." Inside Dorothee's Pot au Feu: The children were home for Thanksgiving; they left with the leftovers Philip L. White, D.Sc. Secretary, Council on Food and Nutrition Laveen Cowbelles Christmas House is Saturday Director, Foods and Nutrition Department Gompers tots learn all about tacos American Medical Association (Chieago) Friends of Mexican Art serve Mexican coffee and cookies Minnesota author writes a historical cookbook , - K-2 The Arizona Republie Phoenix, Wed.,Dec.3,1975 ONE CALL DOES IT ALL Information crisis' revealed "CHARGE-IT" BEEF SALE NO PAYMENT TILL JANUARY 5 NEXT YEAR! The times have Food and in 90 DAYS, SAME AS CASH 3 EQUAL PAYMENTS Crisis!, was people together, cently by the Sugar As- creating a competitive 'Scientists won't promise to cure Put BEEF Back In PRICES EFFECTIVE sociation, Inc. spirit. If they are properly FOOD advised by a good nutri- arthritis or cancer; but 'health' THRU WEDNESDAY J W. Tatem Jr., presi- dent of the association, tion consultant they can food people do make such claims, promises' introduced the panel of helpful. Your Budget! DEC. 10th STAMPS ACCEPTED three scientists and White: If people are added: going to count calories BABY BEEF (1)USDA CHOICE one's peers agree with the Jukes: Part of the prob- viding scholarships and information? lem is that the scientific fellowships to enhance SPECIAL BABY BEEF Moderator: (Tatem): story is a dull one. We this; a great deal is going USDA INSPECTED Any scientist associated can't promise people 20 on. 200-300 Lbs. USDA CHOICE Avg. Wt. with industry is immedi- years more of life, or how COMMENT ON "Nutrition information ately. suspect, so many to cure arthritis or can- HYPERKINESIS? 59e BEEF HALF 200-300 Lb. 86 Lb. scientists prefer to go cer. But the "health" food Lb. Plus Rib Section Cutting and wrapping free. Subject to all has been taken over by back to their labs and people do. Reliable infor- Barrett: Far too many cutting and trimloss. opportunists promoting mation is available people are called hyperac- Cutting and wrapping write theses. Fred Stare, free. Subject to all out- M.D. is dedicated scien- through the FDA, AMA, tive than should be. 84e (2) USDA GOOD ting and frim loss. questionable, harmful products' Lb. tist, he speaks his own American Institute of White: Another (talk opinions, and nobody Nutrition, American Soci- show book) tragedy. Even Cutting and wrap- BABY BEEF BABY BEEF ping free. Subject elses. Many (faddists) ety of Clinical Nutrition, the title "Why Your Child to all cutting and disagree with him, be- American Pediatric As- is Hyperactive" is sensa- HIND QUARTERS frim loss. Avg. Wt. cause they don't under- sociation. itionalized. 200-300 Lb. 84°. stand the medical imput (Sold in Two's Only) GUARANTEED TO SATISFY. IF NOT Cutting and wrapping free. Subject to all of what Fred has to say. COMPLETELY SATISFIED, RETURN cuffing and trim loss. "Information about they should learn the rela- His newspaper columns nutrition has drifted away tionship between the serv- tell the truth - they don't Avg Wt. WITHIN FIVE DAYS & YOUR ORDER from the medical and 175-200 Lbs. WILL BE REPLACED ON AMOUNT RE- (3) USDA CHOICE ing sizes of foods and the promise you everlasting Television has unbalanced Lb. TURNED. scientific community to calories. First, be sure life. RIBS & CHUCKS the laymen, including a your diet is a good one; nutrition information in Cutting and wrapping free. Subject to all - goodly number of oppor- then, eat smaller por- Jukes: In some cases a terrible way' outting and trim loss. FREE! Seef. Boneloss 800 ribs soup bone Liver. Steak Chuck tunists, promoting ques- tions. It is the amount of the reason for dropping Avg. Wt. 300 400 Lb. tionable and often harm- food you eat, the total Dr. Stare's column has USDA CHOICE 50 Pcs. Pork Chops Cuffing and wrap- ful products,' he said. calories that is important. been an organized write- Or ping free. Subject 15 Lbs. Fryers to all cutting and 69° "Fortunately, there has SHOULD NEWSPAPERS in in behalf of the organic BEEF HALF frim loss. been a backlash, and now PUBLISH THE FAD- food movement. ARE MEDICAL DOC. With purchase of 1/2 beef or more the scientific community DISTS' VIEW? TORS TRAINED IN USDA CHOICE WHY DOESN'T SCIENCE KEN'S MARKET is directing itself to re- Barrett: No. There is no NUTRITION? Avg. Wt. C storing crucial respon- balance Television GET ITS now. MESSAGE 3216 E. Camelback Rd. White: All physicians 300-350 lb. 1/2 HOG HEAVY BEEF sibility to those with are given some exposure Lb. professional credentials. to nutrition, although it featuring Oufting and wrapping free. Subject to all Contains: Ham, bacon, pork chops, pork Net may not be labeled as EASTERN VEAL After giving their pre- cufting and trim loss. steak, spare ribs, picnic ham, country EASTERN PORK back bones, pork roast sausage. BEEF 2 lbs. Weight $599 such. They have basic pared talks, the three speakers answered ques- 'An organized write-in science courses in bio- tions, among them, the chemistry, physiology, USDA GOOD Avg. wf. by organic food movement USDA AMERICAN 100-125 lbs. 129 Cutting and wrapping free. Subject to all Lb. cutting and trimlloss. pharmacology and all the following: stopped Dr. Stare column' way through their train- CHOICE LAMB BEEF HALF All Cutting And Wrapping Free. Subject DO CALORIES COUNT? USDA CHOICE To All Cutting And Trim Losses. Prime Beef Half ing they are given infor- DO DIET CLUBS HELP? mation that relates nutri- EASTERN BEEF ents to body processes. FILETS Black Angus Beef Half $1 Barrett: "For every What they may be miss. Avg, Wt. 3,500 calorie deficiency ing is an impressionable Check with KEN'S for 300-500 Lb. you will lose pound. So has unbalanced things in ACROSS LIKE THE FAD- your locker Beef cut, 6 Oz. 99e each Swift Premium Beef Half 99°L Lb. course that relates foods eat less. Weight reduction a terrible way. DISTS DO? Swift Proten Beef Half 99°Lb. to nutrients. AMA is pro- wrapped, quick frozen WHO CAN WE BELIEVE Barrett: Part of the Cutting and wrapping free. Subject to all - - to your specifications. cutting and frim loss. 8 Oz. each Cutting and wrapping free. Subject AND TRUST? problem is that there is cufting and trim loss. money involved. The EGG NOG White: It seems the For the hard to buy gift 2 BIG LOCATIONS TO SERVE YOU "health" food industry, ICE CREAM FREE 10 Lbs. Fryers or same three or four nutri- the book publishers. They name nearest for Christmas -give a SUPERIOR MEATS 25 Pos. Pork Chops tionists are always asked With orders 'In dieting, stand to gain a tremen- dealer coll for: quotation to counter- locker beef! dous amount of money by 1826 W. PEORIA - 944-9601 it is total balance misinformation. 254-5353 CALL NOW publicizing what they do. 2205 N. COUNTRY CLUB DR., MESA 834-9810 834-9810 There is a tendency 955-0360 FIRANOE ONAROES WITN calories that People who speak out overuse these three or APPROVED CREDIT ONLY . HOURS 9-6:30, SAT. CLOSED SUN. 994-9601 against health mis-infor- are important four people. Part of the mation are not funded. problem is the number of The "health" food indus- our consultants used is try involves maybe Tily CREAM too small. An important 40 .000 people working full qualification of trust: Do time. Chris Evert serves Introducing New the new slice Fruity Freakies' Cereal for your kids. BORDEN Pro-line SKIM- New Fruity Freakies is a crunchy, fruit flavored cereal your kids will love to eat. And since we're giving AMERICAN you 15c off, it's a crunchy, fruit TM flavored cereal you'll love to try. SLICES PASTEURIZED PROCESS CHEESE PRODUCT 15% MILK FAT And 15c off for you. Half the fat. All the flavor. Fantastic. - - - - - STORE COUPON B5520-5 10 off new Borden Skim-American Slices. 10% 15c OFF ON FRUITY 15c FREAKIES CEREAL 15c OFF OFF 15c 15c STORE COUPON I r Pheenix, Wed., Dec. The Arizona Republie K-3) Satisfy your animal desires Scientists warn against alarmists for 7c less. Not long ago, cat like you had to pay full price for a can of Kitty Salmon. But now, the lucky cat who uses this special coupon can satisfy his desire for salmon with much less capital. More about the nutri- is published in the Ameri- could tell the truth on his tion seminar speakers *National Health Federation and who cannot. Kitty Salmon Dinners come in four different lip- can Medical Association's program, the producer smacking varieties, and every one of them is less with photographed on the cover promotes pseudo-science, quackery' monthly magazine, did not reply.' He also urged fluorida- this lucky cat coupon. page: "Today's Health," ticked tion, and said a campaign So romp on down to your favorite grocery and get your off these points: The psychiatrist urged is underway to discredit it Kitty Salmon today! THOMAS JUKES, D. columns called "Instead by the National Health HE QUOTED a New about "so-called hypo- Sc., is a pioneer in the -In his first diet book of field of vitamins and is glycemia and the special Examples: In- Federation, an organiza- York survey of organic author Irvin Stillman diets suggested for it." stead of taking vitamins, tion he describes as also involved in the space foods from health stores. damned carbohydrates; in learn to eat wisely. In- "promoters and victims program for detecting life A chemical analysis re- FOOD ADDITIVES? his next one he praises stead of fad diets, learn to pseudo-science, on Mars. vealed about 30 per cent them. Will the sequel be count calories. Instead of- promoting quackery and Jukes said: "I got into had detectable levels of "They are as diverse as "The Son of Stillman believing everybody, so-called "health' products food itself," Jukes said. Shuns Starches?" the space program pri- pesticide residues (at learn who can be trusted with false claims.' "You must say which one you mean. The problem of "AMA condemned low-carbohydrate food poisoning does not There are more toxic substances arise from food additives, diets; the publicity increased but from bacterial con- at higher levels naturally present tamination. in foods than are added as additives' book sales by 65% "The interesting thing about food additives is -The AMA's Council that they cause so much marily because of my in- on Nutrition condemned harmless levels) but fmental problems' (worry). Actually there low carbohydrate diets. LETTUCE 5:51 terest in molecular evolu- they were advertised as tion and the origin of life, The publicity increased organic, not containing are more toxic substances but became more and any pesticides. at higher levels naturally book sales by 65 per cent. more involved with nutri- present in foods than are -Nearly all popular APPLES 8:51 tional matters." diet books take consider- 7c 7c A similar check of non- added in the form of addi- organic foods from super- tives,' he said. able liberty with the truth He scored the "stop when developing the ratio- BROCCOLI ONIONS TURNIPS markets showed about 25 feeding grain to cattle' He used mercury found nale for a given diet. In per cent had pesticide controversy as "oversim- in swordfish and tuna as others, one finds some residues (harmless an example. very strange bio-chemical 7:51 10°. 10° Killy levels). SALMON "FEED grains fed to In another health food The diet industry accounts for livestock are not accept- CABBAGE 7. 7C off when you buy any can of Kitty Cat Food. store Jukes said he saw able to the consumer as a 1% of our Gross National Product' Mr. brown rice in two sacks, .direct source of food,' Jukes said. Example: one labeled ordinary; the other, organic, and priced "SWORDFISH was ban- or psysiological explana- Limit twice as much as the ned because of mercury tion of metabolism. FARM 2-U Daily 9-8 Corn is deficient in pro- Reserved Closed tein and other nutrients; content; then it was real- Sunday first. Chemical analysis Stephen Barrett, M.D., I caftle eat not just the showed both were identi- ized that the mercury was appealed to the press to 2 Blocks West of the - - grain part but the cobs naturally present in sea 26th Ave. & Glendale cal. help balance the flood of Black Canyon Freeway and stalks, as well as water and always has A product England Fish Company nutritional misinforma- other roughage that can- been. More research not be consumed by The answer was that tion, especially that from showed there was another television. humans; then they con- the bottom had fallen out element in sea water, se- vert it into meat. of the organic rice mar- lenium, which detoxified Referring to Merv Grif- fin show guests such as Linus Pauling, Carlton He said he often goes to check health 'Health' food stores are Fredericks, the late Adele on food Davis, Roger Williams, stores, prominent prominent sources of nisinformation John Yudkin Rodale source of misinforma- magazines, and others, as tion. "the health food industry ket, so they were having mercury, so that the fish selling its bill of goods," PEPPERIOGE FARM A fellow professor of his to sell it as regular rice, were safe, after all," he Barrett said: checked a sale of alfalfa but were still selling said. "When the National seeds, found among them whatever they could at The diet industry ac- Nutrition twice the price. Consortium a considerable percentage counts for one per cent of of morning glory seeds. Jukes also our Gross National Prod- asked Griffin's producer warned for equal time, so that re- uct. I guess that means sponsibile nutritionists that we spend more than $100 billion on food and $10 billion recovering Food poisoning Feed grains for cattle from its effects," said comes from are not the kind that can be Philip White, Ph.D., at contamination, consumed by humans' the nutrition symposium. not additives' White, whose monthly column, "Smart Eating," Save $1.00 with Nescafé Get savings up to 75c with valuable coupons inside specially marked jars of Nescafé" Instant Coffee. Save 10c on 24-oz. bottle of Welch's GrapeJuice 10c on Quaker* Puffed Cereal, 20c on two Stouffer's* Crumb Cakes, 10c on Armour Treet", /Hash, 10c on 11-Oz. jar of Pream; and 15c on Handi-Wipes* cloths. Save 25c on Nescate too. Clip the coupon below and get 25c off Nescalé* Instant Coffee. R Puiffed Rice vanilla ice cream. Maybe both! NESCAFE Remember the smell of apple pie baking? Crumb Pepperidge Farm remembers. And brings you apple pie tarts, with GRAPE JUICE cinnamon, hazelnuts and a ROTHBERG sprinkling of raisins. 10ç Save 25€ PEPPERIOGE FARM. 10ç Save 100 on 1 box of Apple, Bluebenr, Ona 10-oz.jarof Nescafé" Instant Coffee, Cherry, Lemon, Apple Strawbenry or Pineapple Pie Tarts. 10ç STORE In your 104 6405-7 K-4 The Arizona Republic Phoenix, Wed., Dee. 3, 1975 Collectors' cook-shelf Food on the Frontier' "FOOD ON THE seasons. Most from mem- of zucchini, and lower- FRONTIER" by Marjorie bers; some from Chicago cost soybeans were used Kreidberg (published by restaurants. Order by to provide the family with Author cooks for book the Minnesota Historical writing to the league at protein. Such recipes as Society, 275 recipes, $6.50 1447 N. Aster St., Chicago, Zucchini Quiche and Soy- paperback). In addition to III. 60610. beans Ole. the recipes are some 200 "CUTTING UP IN THE pages of the cooking prob- "LAROUSSE TREAS- The Minnesota author of fascinating new historical revelaing the horrendous conditions under which these KITCHEN" by Merle lems of pioneer women URY OF COUNTRY cookbook spent Thansgiving visiting Scottsdale rela- Ellis (Chronicle Books, women worked -with no complaints. (talk about shortages, COOKING" by the editors tives. $5.95, paperback). Tools adulterated foods, primi- of Librairie Larousse Ten years of research and writing later, Mrs. Kreid- and tricks of the meat The author, Mrs. Irving (Marjorie) Kreidberg, and tive utensils, lack of (Crown Publishers, berg's intriguing historical recount, together with re- trade, as well as a diction- her husband visited her mother, Mrs. Gilbert A. Helz- cipes she herself tested and updated, is complete. money and such depriva- $12.95). Four hundred and ary of beef terms, carv- berg, formerly of Kansas City, and sister and brother- tions as grasshoppers!) fifty recipes for country in-law, Mr. and Mrs. Harold D. Rosoff. Rosoff is vice Curiously, the recipes are not at all ethnic, but Also 100 sketchs of old- ing, preserving, freezing style cookery from not president of food management for the Greyhound Cor- typical to any frontier. "It seems in those days the fashioned cooking para- and how to cut up your just French provinces, pioneers were trying to lose their foreign image, to meat. poration. phernalia and kitchen in- but 50 other countries. assimilate, even through cooking, with America,' the teriors. order send "ZUCCHINI COOK- Many aimed at economy. Mrs. Kreidberg's book, "Food on the Frontier" (see author said. check to MHS Order BOOK" and "SOYBEAN it listed in today's Collectors' Cook-shelf) is the result "COOK AHEAD COOK- "I HOPE THE book will generate more old books, Dept., 1500 Mississippi COOKERY' by Joanne of 10 years of work. ERY" by Theodora Zavin and letters and ethnic recipes to the historical society,' St., St. Paul, Minn. 55101, and Virg Lemley (Wilder- and Fredda Stuart "I WAS AN editorial assistant for the Minnesota she added. adding 50 cents for post- ness House, each, (Crown, $6.95). An enlarg- Historical Society, said Mrs. Kreidberg. "One day I went down two levels of the building and came across She and her husband are both graduates of the age. paperback). About 50 re- ed edition of "The Work- University of Minnesota's School of Journalism. He is "SOUPCON" (by the cipes in each of these lit- ing Wives Cookbook" with an immense collection of 19th century cookbooks. The now president of North Central Publishers. They have Junior League of Chicago, tle books, developed when all recipes based on more read, the more I learned about the hazards and two married sons, Gilbert, a stockbroker, and Roger Republic Photo Inc., .95 plus 65 cents her husband (an electron- preparation the night be- handicaps of homemaking on the frontier. (journalism graduate of Northwestern), who is on the Marjorie Kreidberg and her new book postage, paperback). ics engineer) lost his job fore, including a special "There was also a superb collection of old letters staff of Minnesota governor Wendell Anderson. "Food on the Frontier" More than 600 recipes ar- and her son (a 4-H gar- chapter on cooking for ranged according to the dener) had a bumper crop company. GOLD SUPER SAVINGS SUPER A.J.Bayless BOND Your Home Town Grocer" STAMP DISCOUNT EVERY DAY AT BAYLESS TIDE MILK DOUBLE CARNATION SEASONED Detergent GOLD BOND 49° All Jersey. Giant size. Low Fat. GREEN 49-0z. BOX. HALF GALLON 1e STAMPS PLUS ONE FILLED SUPER DISCOUNT BOOKLET. PLUS ONE FILLED SUPER DISCOUNT BOOKLET. BEANS GOOD DEC.2 thru DEC.8. GOOD DEC.2 thru DEC.8. WEDNESDAY DOLE BRAND. N° 303 CAN. 25 BEEF RAINBOW GROUND BONELESS SOLE TOP PRINGLE BEEF SIRLOIN CHIPS LIVER TROUT CHUCK FILLETS ROAST STEAK Fresh frozen young steer liver. Individually quick frozen. 100% pure Chuck meat. Flash frozen. Beef Chuck Boneless. TWIN PACK. Skin on. Solid pack. Cross Rib cut. Bayless Supreme Beef. 77° LB. 39° LB. $139 99° 89° LB. $169 LB. LB. $199 LB. 3-Oz.PKG. ITALIAN SAUSAGE links. Messina brand. Mild hot. $139 HORMEL WAFER BACON Sliced. Highly selected. Flash frozen. BORDEN'S SKIM. 12-Oz.PKG $139 OSCAR MAYER BOLOGNA Meat Beef 8-Oz. PKG 65° AMERICAN BAR-S BEEF FRANKS 1-L6.PKG 89° OSCAR MAYER BOLOGNA Meat Beef, 12-Oz.P 95e Individually sliced. 12-0z.PKG $119 BAR-S MEAT WIENERS 1-Lb. PKG 89° OSCAR MAYER MEATS variety 12-Oz.PKG $139 CANNED HAM Hormel. Boneless, fully cooked. 5-L6.SIZ $1049 DEL MONTE BROWN 'N SERVE REgular, Hot varieties. 8-Oz.PKG 93e CUBE BEEF STEAK Bayless Supreme Beef. LB $193 FRUIT COCKTAIL APPLES COLE SLAW Deluxe PKG. 19° N. 303 CAN Washington State Red Golden FRESH CARROTS 35 Delicious.Large Extra Fancy. 29° 2-LB. CELLO PKG WALNUTS 29° BABY LB. HORMEL PORK & GIANT PERCH CORNED BEANS FAB FILLETS BEEF VAN CAMP'S DETERGENT. 49 oz. BOX. TOP FROST-1-LB.PKG. 12 oz CAN 25° 97 89° 85 6001 N. 7th 210 E. DUNLAP 6131 N. 35th AVE. 8030 N. 27th AVE. 1617 5542 E. THOMAS 7141 E. LINCOLN 6529 W. INDIAN SCHOOL 2707 W. CAMELBACK 3205 McDOWELL 7007 7th 10620 N. 32nd ST. 4610 N. SCOTTSDALE 12606 N. BLACK CANYON *