Review of EPA's 2022 Draft Formaldehyde Assessment

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Formaldehyde is widely present in the environment and is one of the highest production chemicals by volume, used in manufactured goods including wood products, permanent press fabrics, and household products. It is also formed by combustion sources and is present in smoke from cigarettes and other tobacco products, and in emissions from gas stoves and open fireplaces. In carrying out its mission to protect human health, the U.S. Environmental Protection Agency (EPA) identifies and characterizes the health hazards of chemicals found in the environment through its Integrated Risk Information System (IRIS) Program, which has reviewed the human health hazards resulting from formaldehyde exposure in several assessments.

This report is a continuation of guidance from the National Academies on draft IRIS assessments of formaldehyde and other aspects of the IRIS program. This report reviews the 2022 Draft Assessment with regard to its adequacy and transparency in evaluating the scientific literature, use of appropriate methods to synthesize the current state-of-the science, and presentations of conclusions that are supported by the scientific evidence. The report concludes that the 2022 Draft Assessment follows the advice of prior National Academies reports and that its findings on hazard and quantitative risk are supported by the evidence identified. However, revisions are needed to ensure that users can find and follow the methods used in each step of the assessment for each health outcome.

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173 pages · 7 x 10 · paperback
ISBN Paperback: 0-309-70655-6
ISBN Ebook: 0-309-70656-4
DOI: https://doi.org/10.17226/27153

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National Academies of Sciences, Engineering, and Medicine. 2023. Review of EPA's 2022 Draft Formaldehyde Assessment. Washington, DC: The National Academies Press.

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Jonathan M. Samet

Jonathan M. Samet, a pulmonary physician and epidemiologist, is Dean of the Colorado School of Public Health. Samet’s research has focused on the health risks posed by the environment, including inhaled pollutants and tobacco. He has served on numerous committees concerned with public health and the environment: the U.S. EPA Science Advisory Board; committees of the National Academies, including chairing the Biological Effects of Ionizing Radiation VI Committee, the Committee on Incorporating 21st Century Science in Risk-Based Evaluations, the Committee on Research Priorities for Airborne Particulate Matter, the Committee to Review EPA’s Draft Integrated Risk Information System 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. Samet received his MD from the University of Rochester, School of Medicine and Dentistry and his master’s degree in epidemiology from the Harvard T.H. Chan School of Public Health.

Aisha S. Dickerson

Dr. Aisha S. Dickerson is Assistant Professor of Epidemiology and Bloomberg Professor of American Health in Environmental Challenges at the Johns Hopkins Bloomberg School of Public Health. Dr. Dickerson is originally from Montgomery, Alabama and holds a BS in Biology and MSPH in Epidemiology from the University of Alabama at Birmingham and PhD in Epidemiology from the University of Texas Health Science Center at Houston. She received a year of postdoctoral training at the US Environmental Protection Agency before completing a postdoctoral fellowship at the Harvard T.H. Chan School of Public Health. She is an environmental neuroepidemiologist with primary research interests in environmental risk factors for neurodevelopmental and neurodegenerative disorders including autism spectrum disorder, amyotrophic lateral sclerosis, and dementia. Additionally, she investigates the influence of disparities in autism assessment and service provision along with environmental justice issues in underserved communities.

Dana C. Dolinoy

Dr. Dana Dolinoy serves as NSF International Chair of Environmental Health Sciences and Professor of Environmental Health Sciences and Nutritional Sciences at the University of Michigan School of Public Health as well as Director of the Michigan Lifestage Environmental Exposures and Disease (M-LEEaD) Center. She leads the Environmental Epigenetics and Nutrition Laboratory, which investigates how nutritional and environmental factors interact with epigenetic gene regulation to shape health and disease. Dr. Dolinoy holds a PhD in Genetics and Genomics and Integrated Toxicology from Duke University, and MSc in Public Health from Harvard University, and serves as Associate Editor of Environmental Health Perspectives, Environmental Epigenetics, and Toxicological Sciences, and served as Chair of the Gordon Research Conference in Cellular & Molecular Mechanisms of Toxicity. She has been an invited speaker at numerous national and international meetings and authored more than 130 peer reviewed scientific manuscripts and 10 book chapters. In 2011, Dr. Dolinoy received the Norman Kretchmer Memorial Award from the American Society for Nutrition and the Classic Paper of the Year Award from Environmental Health Perspectives. In 2015, she received a NIH Director’s Transformative Award to develop piRNA epigenetic editing technologies and in 2021 received the Society of Toxicology Leading Edge in Basic Sciences Award and has recently co-edited the book ToxicoEpigenetics: Core Principles and Applications. 2013, Editor, Issue of the ILAR Journal of the National Academies of Sciences, “Epigenetics: A Scientific Advance of Epic Proportions?” Dr. Dolinoy has previously served on the NASEM Veterans and Agent Orange, Committee and as a review expert for the NASEM, Gulf War and Health: Volume 11: Generational Health Effects of Serving in the Gulf War.

David C. Dorman

David C. Dorman is a professor of toxicology in the Department of Molecular Biomedical Sciences at North Carolina State University. His research interests include neurotoxicology, nasal toxicology, pharmacokinetics, and cognition and olfaction in animals. He is an elected fellow of the Academy of Toxicological Sciences, a fellow of the American Association for the Advancement of Sciences, and a diplomate of the American Board of Veterinary Toxicology and the American Board of Toxicology. Dr. Dorman is a National Associate of the Academies and has chaired or served on multiple National Academies committees. He completed a combined PhD and veterinary toxicology residency program at the University of Illinois at Urbana-Champaign and holds a DVM from Colorado State University.

Rakesh Ghosh

Dr. Ghosh is a Senior Scientist at the University of California, San Francisco and teaches Epidemiology and research methods in the School of Medicine. He has a PhD in Environmental Epidemiology with over 15 years of research experience in examining the effects of environmental pollutants on maternal and newborn health. Amongst significant contributions are the first global burden of adverse perinatal outcomes including neonatal mortality attributable to PM2.5 air pollution that was widely covered by media in many countries. In another major contribution his study that was the first to provide novel evidence about the effect of air pollution which goes beyond respiratory health, and is likely more profound, affecting early childhood growth. He has received several conference awards recognizing his cutting-edge work in this field.

Sabine S. Lange

Dr. Sabine Lange is the section manager for the Toxicology, Risk Assessment, and Research Division at the Texas Commission on Environmental Quality (TCEQ). Dr. Lange’s responsibilities include conducting and overseeing: health effects risk assessments of air permit applications, ambient air monitoring projects, and hazardous waste sites; development of chemical toxicity factors; and systematic reviews and independent analyses of risk assessments. Dr. Lange’s research interests include the toxicology and risk assessment of air pollutants, and risk assessment methods used for derivation of toxicity factors. In these areas she has published articles, given invited talks, presented posters, and served as a workshop panel member. She has served on several peer review committees for the US Environmental Protection Agency, including as a former member of the chartered Clean Air Scientific Advisory Committee (CASAC). Dr. Lange received a Bachelor’s degree in biochemistry from the University of Western Ontario in Canada, and completed a Ph.D. and post-doctoral training in biochemistry and molecular carcinogenesis at the University of Texas MD Anderson Cancer Center. Dr. Lange is a Diplomate of the American Board of Toxicology.
TCEQ intends to sponsor a separate National Academies consensus study to provide an independent peer review of TCEQ’s ethylene oxide cancer risk assessment. Dr. Lange is not involved in the procurement of that separate activity.

Andrew F. Olshan

Dr. Andrew Olshan is the Barbara S. Hulka Distinguished Professor, Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill. He served as chair of the department from 2006 to 2018. He is Associate Director of Population Sciences, UNC Lineberger Comprehensive Cancer Center. Dr. Olshan’s major interests include the epidemiology of cancer, perinatal, and pediatric outcomes. His cancer research has focused on genetic and environmental risk factors for childhood cancer, breast cancer, head and neck cancer, and endometrial cancer. He has led multiple cancer studies in North Carolina and nationally. He has been the principal investigator for multiple NCI-, EPA-, and CDC-funded studies. Dr. Olshan has served on the IOM Committees to Review the Health Effects in Vietnam Veterans of Exposure to Herbicides. He was Vice-Chair of the NRC’s Committee to Review the Draft IRIS Assessment of Formaldehyde. He is Editor-in-Chief of Current Epidemiology Reports. He is a past-president of the Society for Epidemiologic Research. Dr. Olshan received his doctorate in Epidemiology from the University of Washington, Seattle and was a postdoctoral fellow at the University of British Columbia, Canada. He joined the Department of Epidemiology at the University of North Carolina, Chapel Hill in 1991.

Ivan Rusyn

Dr. Rusyn is a University Professor in the Department of Veterinary Physiology and Pharmacology in the College of Veterinary Medicine and Biomedical Sciences at Texas A&M University. He is also chair of the Interdisciplinary Faculty of Toxicology at Texas A&M University. His laboratory has an active research portfolio with a focus on the mechanisms of action of environmental toxicants, the genetic determinants of susceptibility to toxicant-induced injury, and the use of new approach methods in regulatory toxicology. His studies on health effects of environmental agents have resulted in over 300 peer-reviewed publications. He is a member of the Research Committee of the Health Effects Institute and was on the Board of Scientific Councilors of the National Institute of Environmental Health Sciences. He has served on several committees of the National Academies, including the Board on Environmental Studies and Toxicology, the Committee on Incorporating 21st Century Science into Risk-Based Evaluations and the Committee on the Design and Evaluation of Safer Chemical Substitutions. Most recently, he chaired the Committee to Review Report on Long-Term Health Effects on Army Test Subjects and the Workshop Committee to Support Development of EPA’s IRIS Toxicological Reviews. Dr. Rusyn received his MD from Ukrainian State Medical University in Kyiv and his PhD in toxicology from the University of North Carolina at Chapel Hill.
Dr. Rusyn co-authored several published peer-reviewed articles on formaldehyde, two systematic literature reviews of epigenetic effects of chemicals, one of which was formaldehyde; and one study that evaluated indoor air quality for a wide range of chemicals, including formaldehyde. In his capacity as Professor, Dr. Rusyn engages with representatives of multiple organizations relevant to this activity (including the EPA, the American Chemistry Council, and TCEQ). He also serves as Principal Investigator of a research consortium funded, in part, by the American Chemistry Council; the funders have no role in directing the research or reviewing publications, and Dr. Rusyn draws no salary from the consortium. Dr. Rusyn testified in a March 27, 2019, Congressional hearing focused on the “EPA’S IRIS Program: Reviewing its Progress And Roadblocks Ahead” (see https://science.house.gov/download/dr-ivan-rusyn).

Lianne Sheppard

Dr. Sheppard is the Rohm & Haas Endowed Professor at the University of Washington School of Public Health. She holds a PhD in biostatistics and is a member of two departments: Environmental and Occupational Health Sciences, and Biostatistics. Her research interests focus on environmental epidemiology and statistical methods for understanding the health effects of environmental and occupational exposures; they include study design, measurement error, exposure modeling and estimation, and estimation of environmental exposure effects with application to a wide range of health outcomes including cancer, brain health, and cardiovascular disease measures. She is a Fellow of the American Statistical Association and the 2020 recipient of the International Society for Environmental Epidemiology (ISEE) Research Integrity Award. She is currently Chair of the Clean Air Scientific Advisory Committee and a member of the EPA Scientific Advisory Board. She previously served on the NRC Committee on Contaminated Drinking Water at Camp Lejeune as well as multiple EPA CASAC, IRIS, and FIFRA panels.

Katya Tsaioun

Dr. Tsaioun is a scientist with the focus on translation of scientific innovations into technologies enabling improvements in public health. She spent two decades in translational drug discovery R&D in assay development for high-throughput screening and ADME and toxicology. Based on this experience, she founded a company leading commercialization and application of drug de-risking technologies. After a successful exit, Dr. Tsaioun has served on the advisory boards of companies, charities, and on the review committees at the NIH, and private foundations focused on developing therapies for neurodegenerative diseases. Currently she is an Executive Director of Evidence-Based Toxicology Collaboration at Johns Hopkins Bloomberg Scholl of Public Health (EBTC), where she leads international efforts to establish evidence-based methodologies and systematic reviews in toxicology. She earned a Ph.D. in Human Nutrition Science from Tufts University Friedman School of Nutrition Science and Policy and completed post-doctoral training in neurochemistry at Harvard Medical School. Dr. Tsaioun served on NAS committees in 2018-2020 on review of IRIS and TSCA systematic review processes.

Joseph Wiemels

Dr. Wiemels is a professor in the Center for Genetic Epidemiology in the Department of Population and Public Health Sciences at USC studying the molecular epidemiology of childhood leukemia and brain cancer. He has been a faculty member for over 21 years, previously at UCSF. His work concentrates on etiology and prevention, incorporating concepts of genetic susceptibility and interaction with environmental exposures and infections. His research group consists of both laboratory- and computational-based scientists who are focused on the interaction of inherited genetics and environmental factors in causing specific mutational and epigenetic changes, and the specific timing of these events during the development of the child. Dr. Wiemels doctoral work examined the metabolism and toxicity of benzene and butadiene, and he has worked throughout his career on establishing mechanistic relationships between environmental agents and cancer risk. Dr. Wiemels was a Leukemia and Lymphoma Society Scholar and is currently an Associate Director of the Norris Comprehensive Cancer Center (NCCC) at USC, and manages the shared resources of the NCCC. He is a member of several scientific societies including AACR and ASH. Dr. Wiemels was also a reviewer of the 2011 Formaldehyde Report.

Lauren Zeise

Lauren Zeise is director of the California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment. She oversees the department’s activities, which include the development of risk assessments, hazard evaluations, toxicity reviews, cumulative impact analyses, frameworks and methods for assessing toxicity and cumulative effects of vulnerability and environmental exposures on communities, and the department’s activities in the California Environmental Contaminant Biomonitoring Program. Dr. Zeise was the 2008 recipient of the Society for Risk Analysis’ Outstanding Practitioners Award. She has served on advisory boards and committees of the US Environmental Protection Agency, the Office of Technology Assessment, the World Health Organization, and the National Institute of Environmental Health Sciences. Dr. Zeise has served on numerous National Academies committees, including the Committee to Review Advances to the IRIS Process, the Committee on Incorporating 21st Century Science in Risk-Based Evaluations, and the Committee to Review EPA’s Draft Integrated Risk Information System Assessment of Formaldehyde. Dr. Zeise received a PhD from Harvard University.

Yiliang Zhu

Yiliang Zhu is Professor and Chief in the Division of Epidemiology, Biostatistics, and Preventive Medicine, School of Medicine at the University of New Mexico (UNM). Prior to joining UNM in 2017, he was Professor, the founding director of the Biostatistics PhD program, the Center for Collaborative Research at the University of South Florida College of Public Health. His research focuses on data analytic methods in health risk assessment, including integrative modeling of biological systems, dose-response modeling, benchmark-dose methods, and uncertainty quantification. He also conducts work in biostatistics methods, health service research, as well as directs an ongoing cohort study of the rural healthcare system and policies in northwestern Loess Plateau China. Dr. Zhu was a Fulbright Scholar studying public policy in China (2012-13) and a Science and Technology Policy Fellow of American Association for the Advancement of Science and USEPA (2013-15). Dr. Zhu has served on a number of National Academies committees, including the Committees related to IRIS and Formaldehyde: Committee to Review EPA’s Draft IRIS Assessment of Formaldehyde, Committee to Review the IRIS Process, and Committee to Review Advances Made to the IRIS Process, among others

Kathryn Guyton

The responsible staff officer for this study is Dr. Kathryn Guyton DABT, a Senior Program Officer on the Board of Environmental Studies and Toxicology at the National Academies. She joined the National Academies after seven years as a Senior Toxicologist at the International Agency for Research on Cancer, World Health Organization. Her prior experience includes eight years as a Toxicologist at the US Environmental Protection Agency, and seven years as the Director of Scientific Affairs at CCS Associates. Dr. Guyton received her BA and PhD from Johns Hopkins University and her postdoctoral training at the US National Institutes of Health. She has been certified as a Diplomate of the American Board of Toxicology since 1998.

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Review of EPA's 2022 Draft Formaldehyde Assessment

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