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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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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

images

THE NATIONAL ACADEMIES PRESS
Washington, DC
www.nap.edu

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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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: 978-0-309-68386-9
International Standard Book Number-10: 0-309-68386-6
Digital Object Identifier: https://doi.org/10.17226/25952

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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.

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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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.

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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.
×

Image

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.

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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.
×

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

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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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

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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Reviewers

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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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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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 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

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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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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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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