The Use of Systematic
Review in EPA’s
Toxic Substances Control Act
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
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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.
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COMMITTEE TO REVIEW EPA’S TSCA SYSTEMATIC REVIEW GUIDANCE DOCUMENT
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
Elizabeth Barksdale Boyle, Project Director
Clifford Duke, Director, Board on Environmental Studies and Toxicology
Andrea Hodgson, Senior Program Officer
Tamara Dawson, Program Coordinator
U.S. Environmental Protection Agency
BOARD ON ENVIRONMENTAL STUDIES AND TOXICOLOGY
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
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
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
Elaine Faustman, University of Washington
R. Jeffrey Lewis, ExxonMobil Biomedical Sciences
David M. Michaels, The George Washington University
Ivan Rusyn, Texas A&M University
Paul Whaley, Lancaster University
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.
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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 Julie Goodman, Gradient; Suzanne Hartigan and Steve Risotto, American Chemistry Council; Patricia Koman, University of Michigan School of Public Health; Jennifer McPartland, Environmental Defense Fund; Robert Sussman, Sussman & Associates; Anthony Tweedale, R.I.S.K. Consultancy; Daniele Wikoff, ToxStrategies; and Tracey Woodruff, University of California, San Francisco.
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
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BOXES, FIGURES, AND TABLES