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TSCA POC Peer Review Report Peer Review Report A Proof-of-Concept Case Study Integrating Publicly Available Information to Screen Candidates for Chemical Prioritization under TSCA May 2021 i Table of Contents Overview ............................................................................................................................................................. 3 Summary of report ............................................................................................................................................. 3 Peer Review Process ........................................................................................................................................... 3 List of peer reviewers and affiliations ............................................................................................................... 4 Charge to Reviewers ........................................................................................................................................... 4 Peer Review Comments ..................................................................................................................................... 5 Reviewer: Tara S. Barton-Maclaren, Ph.D. ...................................................................................................... 5 Reviewer: Weihsueh A. Chiu, Ph.D. ............................................................................................................... 14 Reviewer: Helen M Goeden, Ph.D. ................................................................................................................ 17 Reviewer: Kerry W. Nugent, Ph.D. ................................................................................................................ 24 Reviewer: Edward J. Perkins, Ph.D. ............................................................................................................... 32 CVs ..................................................................................................................................................................... 36 ii Overview EPA staff developed the report, “A Proof-of-Concept Case Study Integrating Publicly Available Information to Screen Candidates for Chemical Prioritization under TSCA,” which presents a proof-of-concept approach to organizing large numbers of chemical substances using publicly available scientific data for further evaluation. This report was identified as Influential Scientific Information (ISI), under the definitions and guidelines of the EPA Peer Review Handbook1. After internal EPA technical review, the report was sent to five independent experts for external peer review. The process was managed by Eastern Research Group, Inc under contract by EPA. The charge to reviewers and the individual responses are contained in this report. Summary of report Regulatory agencies world-wide are looking to efficiently integrate information on chemical substances in order to inform priorities for decisions and data requests. This document presents the Public Information Curation and Synthesis (PICS) approach that integrates publicly available hazard, exposure, persistence, and bioaccumulation information for chemical substances. The PICS approach synthesizes information from traditional and new approach methods (NAMs) to understand the overall degree of potential concern related to human health and the environment as well as the relative coverage of potentially relevant human health and ecological toxicity and exposure information that could inform level of effort and resources that may be needed to evaluate that specific substance. This approach is not designed to replace any existing prioritization processes but aims to increase efficiency and focus expert review on substances that may have a greater potential for selection for further evaluation. A proof-of-concept case study was performed by applying the PICS approach to a subset of the TSCA active inventory. The PICS approach may be applied to large numbers of chemical substances and is an important tool for integrating and synthesizing large amounts of publicly available information. Peer Review Process EPA conducted the independent peer review process using a contract with Eastern Research Group, Inc (hereafter, “ERG”). The peer review process provided a documented, independent, and critical review of the report. For this review, EPA provided ERG with the draft report and a list of required expertise. 1 U.S. Environmental Protection Agency Peer Review Handbook 4th Edition, 2015 (https://www.epa.gov/sites/production/files/2015- 10/documents/epa_peer_review_handbook_4th_edition_october_2015.pdf) 3 Specifically, EPA asked for experts in human health toxicology, ecological toxicology, fate and transport, chemistry and exposure science; and that all reviewers should have broad expertise in the area of toxicology and/or exposure and in vitro methodology, as well as an understanding of new approach methodologies and other applicable guidance particularly as related to chemical risk assessment. ERG was charged with sole responsibility for recruiting qualified peer reviewers and conducting a thorough conflict of interest (COI) screening. During the selection process, ERG developed a list of 10 candidate reviewers, and ultimately selected five peer reviewers (see section 4). EPA provided consent for these reviewers, and ERG certified that these five peer reviewers had no real or perceived COI. ERG also facilitated the peer review by distributing materials and managing the returned reviews. In consultation with EPA, 12 charge questions under five groupings were developed and provided to reviewers (see Section 5). ERG monitored the review and returned responses to EPA. After reviewing the responses, EPA asked ERG for a clarification from one reviewer. The original text and clarification are provided in Dr Edward Perkins’ response for transparency. Section 6 of this Peer Review Report presents the reviewers’ individual written comments. List of peer reviewers and affiliations Dr. Tara S. Barton-Maclaren, Health Canada Dr. Weihsueh A. Chiu, Texas A&M University Dr. Helen M. Goeden, Minnesota Department of Health Dr. Kerry W. Nugent, AICIS (formerly NICNAS) Dr. Edward J. Perkins, Department of Defense Charge to Reviewers 1. OVERALL QUESTIONS Based on your knowledge and understanding of toxicology and/or exposure, chemistry, and risk assessment, please comment on the overall TSCA POC document. 1A. Does this document address the purpose and aims as laid out in the introduction? 1B. Are the ideas presented throughout the document clear and presented in a logical manner? 4 1C. Is the method described in this document appropriate to be scalable to the thousands of chemicals on the TSCA inventory? 1D. Is this approach adaptable to other large-scale chemical prioritization efforts other than for TSCA? 2. SCIENTIFIC DOMAINS Based on your knowledge of toxicology, chemistry, risk assessment, and/or exposure science, please comment on the evaluation, workflow, and metrics developed for the individual scientific domains in the TSCA POC. 2A. Were the decisions in each of the domain-specific evaluations logical and based on sound science? 2B. Do you see any significant issues with any of the tiered workflows and metrics developed for these scientific domains? If so, please identify and explain those issues. For each of the scientific domains, there is a discussion of limitations and longer-term options. Based on your knowledge of toxicology, chemistry, and/or exposure science: 2C. Are the appropriate limitations and long-term options included for each domain? 2D. Are there additional long-term options that could be included? 3. INFORMATION AVAILABILITY 3A. How clearly and concisely are the descriptions of purpose and methodology of the information availability presented? Please identify areas where additional clarity is needed. 4. RESULTS and CONCLUSIONS 4A. Are the results of the TSCA POC clearly described and presented? If no, please identify areas where clarity is needed. 4B. Do the results presented adequately support the conclusions? If no, please identify and explain those issues. 5. EDITORIAL OR ADDITIONAL COMMENTS 5A. Please provide any editorial or additional comments you would like to make here. These should be any comments that are not in direct response to the technical charge questions above. Peer Review Comments Reviewer: Tara S. Barton-Maclaren, Ph.D. Sr Research Manager, Emerging Approaches Unit, Health Canada, Healthy Environments and Consumer Safety Branch, Ontario, Canada Thank you for the opportunity to review the EPA TSCA Proof-of-Concept Case study. This is a well written and clear document outlining the data sources, methods and outcomes of the approach relative to the chemical space selected to illustrate the utility and sensitivity of the tool. Introducing automated approaches to enhance the efficiency of chemical screening and prioritization is an area under exploration and development is risk assessment programs internationally. The thoughtful integration of data and technical advancements described and tested in this PICS approach will provide a useful foundation to support modernizing approaches to priority setting in programs external to the EPA. 5 For transparency, I would like to acknowledge that my review focused on the details related to the human health hazard and exposure domains. The ecological domains are outside the scope of my scientific expertise. 1. OVERALL QUESTIONS Based on your knowledge and understanding of toxicology and/or
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