Review of EPA's TSCA Systematic Review Guidance Document

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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.

Publication information

82 pages · 8.5 x 11 · paperback
ISBN Paperback: 0-309-68386-6
ISBN Ebook: 0-309-68387-4
DOI: https://doi.org/10.17226/25952

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.

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Jonathan M. Samet

Jonathan M. Samet (NAM) is a pulmonary physician and epidemiologist. He is the Dean of the Colorado School of Public Health. Dr. Samet’s research has focused on the health risks posed by inhaled pollutants. He has served on numerous committees concerned with public health: the US Environmental Protection Agency’s Clean Air Scientific Advisory Committee; committees of the National Academies, including chairing the Biological Effects of Ionizing Radiation (BEIR) VI Committee, the Committee on Research Priorities for Airborne Particulate Matter, the Committee to Review EPA’s Draft IRIS Assessment of Formaldehyde, the Committee to Review the IRIS Process, and the Board on Environmental Studies and Toxicology, among others; and the National Cancer Advisory Board. He is a member of the National Academy of Medicine. Dr. Samet received his MD from the University of Rochester, School of Medicine and Dentistry and master’s degree in epidemiology from the Harvard T.H. Chan School of Public Health.

Deborah H. Bennett

Deborah H. Bennett is a Professor in the Division of Environmental and Occupational Health at the University of California, Davis School of Medicine. Her research focuses on the measurement and modeling of organic compounds in the indoor environment. She has served on various U.S. Environmental Protection Agency Science Advisory boards, panels, and advisory committees related to the Exposure Factors Handbook, and Exposure Metrics for the National Children’s Study. She has served as Estimation Associate Editor for the Journal of Exposure Science and Environmental Epidemiology. She has served as an Elected Councilor, Treasurer, and Chair of the Awards Committee for the International Society of Exposure assessment. She has an MS and PhD from the University of California, Berkeley.

Bryan W. Brooks

Bryan W. Brooks is a Distinguished Professor, Environmental Science and Biomedical Studies at Baylor University. His scholarship incorporates laboratory and field studies in environmental toxicology and chemistry, environmental health, hazard & risk assessment, and water resources. He leads harmful algal blooms research for the Center for Oceans and Human Health and Climate Change Interactions (OHHC2I), a NIEHS Center based at the University of South Carolina. Prof. Brooks serves as Editor-in-Chief of Environmental Science and Technology Letters. Dr. Brooks has an MS from the University of Mississippi and a PhD from the University of North Texas.

Jessica L. Myers

Jessica L. Myers is a toxicologist and risk assessor. She is currently working at the Texas Commission on Environmental Quality where she has drafted guidance on the development of systematic reviews for toxicity factors. She has a bachelor’s and PhD in cell and molecular biology from the University of Texas at Austin.

Kristi Pullen Fedinick

Kristi Pullen Fedinick is a Senior Scientist and the Director of Science and Data in the Healthy People & Thriving Communities (HPTC) Program at the Natural Resources Defense Council. She also serves as part-time faculty in the Department of Environmental and Occupational Health of the Milken Institute School of Public Health at The George Washington University. Dr. Pullen Fedinick’s research career includes experience in environmental health and policy; molecular, structural, and computational biology; biochemistry; and population health. Prior to joining NRDC, she worked as a scientist for a Chicago-based environmental non-profit, where she focused on air and drinking water quality, science communications, and environmental justice. Her current work focuses on the use of high-throughput technologies, predictive toxicology, and computational approaches to chemical risk assessments. Additional work includes the geospatial and statistical analysis of chemicals in the environment, with a particular emphasis on drinking water and on the disproportionate impact of chemical exposures in vulnerable populations. She holds a bachelor’s degree in biochemistry and molecular biology from the University of Maryland Baltimore County and a Ph.D. in molecular and cell biology with a focus on structural biology and biochemistry from the University of California, Berkeley. She was a Robert Wood Johnson Foundation Health and Society Scholar at the Harvard T. H. Chan School of Public Health.

Karen A. Robinson

Karen A. Robinson is a Professor of Medicine at the Johns Hopkins University School of Medicine. She is also director of the Johns Hopkins University Evidence-based Practice Center and is a member of the core faculty in the Center for Clinical Trials and Evidence Synthesis at the university’s Bloomberg School of Public Health. Dr. Robinson’s research focuses on evidence-based health care and evidence-based research. She conducts systematic reviews that are used to develop clinical practice guidelines and to inform other health decisions. She served on the National Academies Committee on Endocrine-Related Low-Dose Toxicity, the Committee to Review Advances Made to the IRIS Process, the Committee to Review DOD’s Approach to Deriving an Occupational Exposure Level for Trichloroethylene and the Committee to Review EPA’s IRIS Assessment Plan for Inorganic Arsenic. Dr. Robinson received an MSc in health sciences from the University of Waterloo, Ontario, and a PhD in epidemiology from the Johns Hopkins Bloomberg School of Public Health.

Joseph V. Rodricks

Joseph V. Rodricks is a founding Principal of ENVIRON (now Ramboll), and an internationally recognized expert in toxicology and risk analysis. He has consulted for hundreds of manufacturers, new product developers, and government agencies in the evaluation of health risks associated with human exposure to chemical substances of all types. Joseph came to consulting after a 15-year career as a scientist at the US Food and Drug Administration (USFDA). In his last four years at the USFDA, he served as Associate Commissioner for Health Affairs. His experience extends from pharmaceuticals, medical devices, consumer products and foods, to occupational chemicals and environmental contaminants. He has served on the National Research Council’s Board on Environmental Studies and Toxicology, and on more than 40 boards and committees of the National Academy of Sciences and the Institute of Medicine, including the committees that produced the seminal works Risk Assessment in the Federal Government: Managing the Process (1983), and Science and Decisions–Advancing Risk Assessment (2009). Most recently he served on the National Academies committee that issued Guiding Principles for Developing Dietary Reference Intakes Based on Chronic Disease. He has more than 150 scientific publications and has received 11 honorary awards from professional societies and other academic and non-academic institutions. He is author of the widely-used text, Calculated Risks, now in its second edition, published by Cambridge University Press, and has presented more than 300 lectures in countries around the world. Dr. Rodricks earned his PhD in Biochemistry from the University of Maryland, College Park.

Katya Tsaioun

Katya Tsaioun is Director of the Evidence-based Toxicology Collaboration at the Johns Hopkins Bloomberg School of Public Health. The collaboration’s mission is to bring together the international toxicology community to facilitate use of evidence-based toxicology to inform regulatory, environmental, and public health decisions. She received her PhD in human nutrition science from Tufts University Friedman School of Nutrition Science and Policy.

Yiliang Zhu

Yiliang Zhu is a Professor in the Division of Epidemiology, Biostatistics, and Preventive Medicine, School of Medicine at the University of New Mexico (UNM). He directs the biostatistics, epidemiology, and research design cores for the Clinical and Translational Research Center of UNM and for the Mountain West Clinical and Translational Research Infrastructure Network, a consortium of 13 universities in seven states. His research focuses on quantitative methods in health risk assessment, including integrative modeling of biological systems, dose-response modeling, benchmark-dose methods, and uncertainty quantification. He also conducts research in biostatistics methods, clinical- and health-outcome evaluation, and impact assessment of healthcare systems and policies in northwestern rural China. Before joining UNM Dr. Zhu was a professor at University of South Florida College of Public Health where he directed the Biostatistics PhD program and the Center for Collaborative Research. Dr. Zhu has served on several National Academies committees, including the Committee on EPA’s Exposure and Human Health Assessment of Dioxin and Related Compounds, the Committee on Tetrachloroethylene, the Committee to Review EPA’s Draft IRIS Assessment of Formaldehyde, and the Committee to Review the IRIS Process. He received a PhD in statistics from the University of Toronto.

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Review of EPA's TSCA Systematic Review Guidance Document

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The Use of Systematic Review in EPA's Toxic Substances Control Act Risk Evaluations

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