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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. The Use of Systematic Review in EPA's Toxic Substances Control Act Risk Evaluations. Washington, DC: The National Academies Press. doi: 10.17226/25952.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. The Use of Systematic Review in EPA's Toxic Substances Control Act Risk Evaluations. Washington, DC: The National Academies Press. doi: 10.17226/25952.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. The Use of Systematic Review in EPA's Toxic Substances Control Act Risk Evaluations. Washington, DC: The National Academies Press. doi: 10.17226/25952.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. The Use of Systematic Review in EPA's Toxic Substances Control Act Risk Evaluations. Washington, DC: The National Academies Press. doi: 10.17226/25952.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. The Use of Systematic Review in EPA's Toxic Substances Control Act Risk Evaluations. Washington, DC: The National Academies Press. doi: 10.17226/25952.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. The Use of Systematic Review in EPA's Toxic Substances Control Act Risk Evaluations. Washington, DC: The National Academies Press. doi: 10.17226/25952.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. The Use of Systematic Review in EPA's Toxic Substances Control Act Risk Evaluations. Washington, DC: The National Academies Press. doi: 10.17226/25952.
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Page viii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. The Use of Systematic Review in EPA's Toxic Substances Control Act Risk Evaluations. Washington, DC: The National Academies Press. doi: 10.17226/25952.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. The Use of Systematic Review in EPA's Toxic Substances Control Act Risk Evaluations. Washington, DC: The National Academies Press. doi: 10.17226/25952.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. The Use of Systematic Review in EPA's Toxic Substances Control Act Risk Evaluations. Washington, DC: The National Academies Press. doi: 10.17226/25952.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. The Use of Systematic Review in EPA's Toxic Substances Control Act Risk Evaluations. Washington, DC: The National Academies Press. doi: 10.17226/25952.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2021. The Use of Systematic Review in EPA's Toxic Substances Control Act Risk Evaluations. Washington, DC: The National Academies Press. doi: 10.17226/25952.
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PREPUBLICATION COPY The Use of Systematic Review in EPA’s Toxic Substances Control Act Risk Evaluations Committee to Review EPA’s TSCA Systematic Review Guidance Document Board on Environmental Studies and Toxicology Division on Earth and Life Studies A Consensus Study Report of

THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001 This activity was supported by a contract between the National Academy of Sciences and the U.S. Environmental Protection Agency. Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project. International Standard Book Number-13: 978-0-309-XXXXX-X International Standard Book Number-10: 0-309-XXXXX-X Digital Object Identifier: https://doi.org/10.17226/25952 Additional copies of this publication are available from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http://www.nap.edu. Copyright 2021 by the National Academy of Sciences. All rights reserved. Printed in the United States of America Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2021. The Use of Systematic Review in EPA’s Toxic Substances Control Act Risk Evaluations. Washington, DC: The National Academies Press. https://doi.org/10.17226/25952.

The National Academy of Sciences was established in 1863 by an Act of Congress, signed by President Lincoln, as a private, nongovernmental institution to advise the nation on issues related to science and technology. Members are elected by their peers for outstanding contributions to research. Dr. Marcia McNutt is president. The National Academy of Engineering was established in 1964 under the charter of the National Academy of Sciences to bring the practices of engineering to advising the nation. Members are elected by their peers for extraordinary contributions to engineering. Dr. John L. Anderson is president. The National Academy of Medicine (formerly the Institute of Medicine) was established in 1970 under the charter of the National Academy of Sciences to advise the nation on medical and health issues. Members are elected by their peers for distinguished contributions to medicine and health. Dr. Victor J. Dzau is president. The three Academies work together as the National Academies of Sciences, Engineering, and Medicine to provide independent, objective analysis and advice to the nation and conduct other activities to solve complex problems and inform public policy decisions. The National Academies also encourage education and research, recognize outstanding contributions to knowledge, and increase public understanding in matters of science, engineering, and medicine. Learn more about the National Academies of Sciences, Engineering, and Medicine at www.nationalacademies.org.

Consensus Study Reports published by the National Academies of Sciences, Engineering, and Medicine document the evidence-based consensus on the study’s statement of task by an authoring committee of experts. Reports typically include findings, conclusions, and recommendations based on information gathered by the committee and the committee’s deliberations. Each report has been subjected to a rigorous and independent peer-review process and it represents the position of the National Academies on the statement of task. Proceedings published by the National Academies of Sciences, Engineering, and Medicine chronicle the presentations and discussions at a workshop, symposium, or other event convened by the National Academies. The statements and opinions contained in proceedings are those of the participants and are not endorsed by other participants, the planning committee, or the National Academies. For information about other products and activities of the National Academies, please visit www.nationalacademies.org/about/whatwedo.

Committee to Review EPA’s TSCA Systematic Review Guidance Document Members Jonathan M. Samet (NAM) (Chair), Colorado School of Public Health, Aurora Deborah H. Bennett, University of California, Davis Bryan W. Brooks, Baylor University, Waco, TX Jessica L. Myers, Texas Commission on Environmental Quality, Austin Kristi Pullen Fedinick, Natural Resources Defense Council, Washington, DC Karen A. Robinson, Johns Hopkins University School of Medicine, Baltimore, MD Joseph V. Rodricks, Ramboll, Arlington, VA Katya Tsaioun, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD Yiliang Zhu, University of New Mexico, Albuquerque Staff Elizabeth Barksdale Boyle, Project Director Clifford Duke, Director, Board on Environmental Studies and Toxicology Andrea Hodgson, Senior Program Officer Tamara Dawson, Program Coordinator Sponsor U.S. Environmental Protection Agency Prepublication Copy v

Board on Environmental Studies and Toxicology Members William H. Farland (Chair), Colorado State University, Fort Collins Dana Boyd Barr, Emory University, Atlanta, GA Ann M. Bartuska, U.S. Department of Agriculture (retired), Washington, DC E. William Colglazier, American Association for the Advancement of Science, Washington, DC Francesca Dominici, Harvard University, Boston, MA George Gray, The George Washington University, Washington, DC R. Jeffrey Lewis, ExxonMobil Biomedical Sciences, Inc., Annandale, NJ Germaine M. Buck Louis, George Mason University, Fairfax, VA Linsey C. Marr, Virginia Polytechnic Institute and State University, Blacksburg R. Craig Postlewaite, U.S. Department of Defense, Burke, VA Reza J. Rasoulpour, Corteva Agriscience, Indianapolis, IN Ivan Rusyn, Texas A&M University, College Station Deborah L. Swackhamer, University of Minnesota, St. Paul Joshua Tewksbury, Future Earth, Boulder, CO Sacoby M. Wilson, University of Maryland, College Park Staff Clifford Duke, Director Raymond A. Wassel, Scholar and Director of Environmental Studies Kaley Beins, Associate Program Officer Laura Llanos, Finance Business Partner Tamara Dawson, Program Associate Cesar Segovia, Program Assistant vi Prepublication Copy

Acknowledgments This Consensus Study Report was reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the National Academies of Sciences, Engineering, and Medicine in making each published report as sound as possible and to ensure that it meets the institutional standards for quality, objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We thank the following individuals for their review of this report: Lisa Bero, University of Colorado Anna Beronius, Karolinska Institutet Carol J. Burns, Burns Epidemiology Consulting Anne Fairbrother, Exponent Jeff Lewis, ExxonMobil Biomedical Sciences David M. Michaels, The George Washington University Ivan Rusyn, Texas A&M University Paul Whaley, Lancaster University Elaine Faustman, University of Washington Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations of this report nor did they see the final draft before its release. The review of this report was overseen by David Eaton (NAM), University of Washington and Gary Ginsberg, New York State Department of Health. They were responsible for making certain that an independent examination of this report was carried out in accordance with the standards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the authoring committee and the National Academies. Prepublication Copy vii

Preface In 2016, the Frank R. Lautenberg Chemical Safety for the 21st Century Act (“Lautenberg Act”) (Pub L No. 114-182) was signed to overhaul the Toxic Substances Control Act (TSCA), 40 years after the original act was passed. The Lautenberg Act requires the U.S. Environmental Protection Agency’s (EPA’s) Office of Pollution Prevention and Toxics (OPPT) to evaluate chemicals existing before the original 1976 TSCA was amended. Given that several committees of the National Academies have recommended that EPA use systematic review to improve transparency and objectivity of risk-based decisions, it is commendable that OPPT has begun to apply systematic review methods in the risk evaluations produced under TSCA. However, OPPT is under unique challenges in embarking on the use of systematic review in TSCA risk evaluations, due to the ambitious statutory deadlines, the diverse evidence streams considered, and the need to consider many different uses of the chemicals that undergo the evaluations. In this report, the Committee to Review EPA’s TSCA Systematic Review Guidance Document offers practical recommendations that EPA’s OPPT could use to improve use of systematic review and more generally evidence-based practices within the risk evaluations. The committee gratefully acknowledges the following for their presentations: Yousuf Ahmad, Stanley Barone, Amy Benson, Susanna Blair, Francesca Branch, Iris Camacho, Marcy Card, Kellie Fay, Tala Henry, Ariel Hou, Kara Koehrn, Yadi Lopez, Amelia Nguyen, Chantel Nicolas, Nerija Orentas, Katherine Philips, Tameka Taylor, Amina Wilkins, and Eva Wong from EPA OPPT, who described and answered questions on the processes used in TSCA risk evaluations. Others who provided presentations and public testimony include Tracey Woodruff, University of California, San Francisco; Steve Risotto and Suzanne Hartigan, American Chemistry Council; Jennifer McPartland, Environmental Defense Fund; Julie Goodman, Gradient; Patricia Koman; Robert Sussman, Sussman & Associates; Anthony Tweedale, R.I.S.K. Consultancy; and Daniele Wikoff, ToxStrategies. The committee is also grateful for the assistance of the National Academies’ staff in preparing this report. Staff members who contributed to this effort are Elizabeth Boyle, project director; Clifford Duke, director of the Board on Environmental Studies and Toxicology; Andrea Hodgson, senior program officer; and Tamara Dawson, program coordinator. I would especially like to thank the committee members for their efforts throughout the development of this report. Jonathan M. Samet, Chair Committee to Review EPA’s TSCA Systematic Review Guidance Document Prepublication Copy ix

Contents SUMMARY ................................................................................................................................................. 1 1 INTRODUCTION ................................................................................................................................ 9 The Committee, Its Task, and Its Approach, 11 Organization of the Report, 13 2 EVALUATION OF THE TSCA SYSTEMATIC REVIEW APPROACH ................................... 14 Introduction, 14 General Findings, 17 Problem Formulation and Protocol Development, 18 Evidence Identification, 27 Evaluation of the Evidence, 35 Evidence Synthesis, 40 Evidence Integration, 46 3 CROSSCUTTING ISSUES WITH THE TSCA APPROACH ...................................................... 52 Introduction, 52 Overall Findings, 52 The Use of Systematic Review for the Risk Evaluations, 53 Development of New Methods or Utilization of Existing Methods, 54 Weight of Evidence, 54 Enhancing Clarity of Documentation of the Assessment Methods, 55 Summary, 55 REFERENCES .......................................................................................................................................... 57 APPENDIXES A BIOGRAPHICAL INFORMATION ON THE MEMBERS OF THE COMMITTEE TO REVIEW EPA’S TSCA SYSTEMATIC REVIEW GUIDANCE DOCUMENT .................. 61 B PUBLIC MEETING AGENDAS ...................................................................................................... 64 C DOCUMENTS REVIEWED BY THE COMMITTEE .................................................................. 69 BOXES, FIGURES, AND TABLES BOXES S-1 The Committee’s Approach to the Evaluation, 2 1-1 Statement of Task, 12 2-1 OPPT Uses Different Terms to Define PECO Statements for Different Evidence Streams, 24 2-2 PECO Statement for General Exposures in the TCE Risk Evaluation, 24 2-3 RESO Statement Example from the TCE Risk Evaluation, 25 2-4 Weight of the Scientific Evidence and Evidence Integration, 47 Prepublication Copy xi

Contents FIGURES S-1 Example approach of systematic review in the context of risk assessment, 3 S-2 The systematic review process for TSCA risk evaluations, 5 1-1 The components that feed into TSCA risk evaluations, 11 2-1 Example approach of systematic review in the context of risk assessment, 15 2-2 The systematic review process for TSCA risk evaluations, 16 2-3 Literature searching process for TSCA risk evaluations, 29 2-4 Committee’s interpretation of the OPPT approach to identifying and selecting evidence in the TCE and 1-BP risk evaluations, 31 2-5 Literature flow diagram for human health hazard from TCE risk evaluation, 32 2-6 Evidence integration for TSCA risk evaluations, 48 TABLES 1-1 Terms as Defined in Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act, 10 2-1 Health Hazard Assessment PECO Statement from the 1-BP Risk Evaluation, 22 2-2 Search Strategies and Terms in TSCA Risk Evaluations, 29 2-3 Inclusion and Exclusion Criteria for the TCE Risk Evaluation, 33 2-4 TSCA Data Quality Domains by Data Stream, 38 xii Prepublication Copy

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Systematic review - a scientific investigation that focuses on a specific question and uses explicit, prespecified scientific methods to identify, select, assess, and summarize the findings of similar but separate studies - has become the foundation for assessing evidence to be used for decision making in a variety of health contexts, including health care and public health.

At the request of the Environmental Protection Agency (EPA), this publication reviews EPA's 2018 guidance document Application of Systematic Review in TSCA (Toxic Substances and Control Act) Risk Evaluations and associated materials to determine whether the process is comprehensive, workable, objective, and transparent.

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