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Review of the Environmental Protection Agency's State-of-the-Science Evaluation of Nonmonotonic Dose-Response Relationships as they Apply to Endocrine Disruptors (2014)

Chapter: Appendix: Biosketches of the Committee to Review EPA's Draft State of the Science Paper on Nonmonotonic Dose Response

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Suggested Citation:"Appendix: Biosketches of the Committee to Review EPA's Draft State of the Science Paper on Nonmonotonic Dose Response." National Research Council. 2014. Review of the Environmental Protection Agency's State-of-the-Science Evaluation of Nonmonotonic Dose-Response Relationships as they Apply to Endocrine Disruptors. Washington, DC: The National Academies Press. doi: 10.17226/18608.
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Appendix

Biosketches of the Committee to Review EPA’s Draft State of the Science Paper on Nonmonotonic Dose Response

David A. Savitz (Chair) is professor of epidemiology and obstetrics and gynecology at Brown University. His primary research interests are in reproductive and environmental epidemiology. He has conducted studies of the causes of adverse pregnancy outcomes, including miscarriage and preterm birth, and pregnancy complications, birth defects, and child health problems. His environmental interests include a wide array of chemical and physical exposures, including exposures to perfluorinated chemicals, pesticides, drinking-water treatment byproducts, and nonionizing radiation. Dr. Savitz was president of the Society for Epidemiologic Research and the Society for Pediatric and Perinatal Epidemiologic Research. He is on the Executive Council of the International Society for Environmental Epidemiology. He has served on several Institute of Medicine (IOM) and National Research Council committees, most recently on the IOM Committee on Obesity Prevention Policies for Young Children. Dr. Savitz was elected to IOM in 2007. He received his PhD in epidemiology from the University of Pittsburgh Graduate School of Public Health.

Andrea Baccarelli is the Mark and Catherine Winkler Associate Professor in the Department of Environmental Health of the Harvard School of Public Health. His Laboratory of Human Environmental Epigenetics investigates molecular mechanisms and biomarkers that reflect reprograming of health and disease trajectories in response to environmental exposures. He is particularly interested in the epigenome and mitochondriome at different life stages. Recent and current projects investigate effects of exposure to particulate air pollution, metals, bisphenol A, phthalates, and pesticides. Dr. Baccarelli received his MD from the University of Perugia, his MPH from the University of Turin, and his PhD from the University of Milan in Italy.

Robert E. Chapin is a senior research fellow at Pfizer, Inc., working in the Developmental and Reproductive Toxicology Center of Expertise. The center helps to interpret and weigh reproductive and developmental data for the organization, is involved in the development and application of in vitro models to screen

Suggested Citation:"Appendix: Biosketches of the Committee to Review EPA's Draft State of the Science Paper on Nonmonotonic Dose Response." National Research Council. 2014. Review of the Environmental Protection Agency's State-of-the-Science Evaluation of Nonmonotonic Dose-Response Relationships as they Apply to Endocrine Disruptors. Washington, DC: The National Academies Press. doi: 10.17226/18608.
×

compounds, and conducts mechanistic work in developmental and reproductive toxicology. He was the recipient of the Pfizer Achievement Award in 2010. Before joining Pfizer in 2002, Dr. Chapin ran the reproductive toxicology laboratory for the National Toxicology Program at the National Institute of Environmental Health Sciences. He received the National Institutes of Health Director’s Award for Scientific Merit in 1995. Dr. Chapin received his PhD in pharmacology from the University of North Carolina at Chapel Hill.

Richard A. Corley is laboratory fellow in the systems toxicology group at the Pacific Northwest National Laboratory operated by Battelle for the US Department of Energy. He specializes in the development of physiologically based pharmacokinetic models and multiscale computational fluid-dynamics–based models of the respiratory system. He has published numerous peer-reviewed papers in toxicology, pharmacokinetic modeling, and cross-species dosimetry applications in human health risk assessments. Dr. Corley was member of the National Research Council Committee to Review EPA’s Draft IRIS Assessment of Formaldehyde, Committee on Risk Analysis Issues and Reviews, and Committee to Assess the Health Implications of Perchlorate Ingestion. He received his PhD in environmental toxicology and veterinary biosciences from the University of Illinois at Urbana-Champaign.

George P. Daston is Victor Mills Society Research Fellow at the Procter & Gamble Company and an adjunct professor of pediatrics at the University of Cincinnati. His current research efforts are in toxicogenomics and mechanistic toxicology, particularly in addressing how findings in these fields can improve risk assessment of chemicals and the development of nonanimal alternatives. Dr. Daston has served as president of the Teratology Society, councilor of the Society of Toxicology, member of the Environmental Protection Agency’s Science Advisory Board, member of the National Toxicology Program’s Board of Scientific Counselors, and member of the National Children’s Study Advisory Committee. He has also served on several National Research Council committees, most recently as a member of the Committee on Use of Emerging Science for Environmental Health Decisions. Dr. Daston has been awarded the Distinguished Service Award by the Teratology Society and the George H. Scott Award by the Toxicology Forum and is an elected fellow of the American Association for the Advancement of Science. He received his PhD from the University of Miami.

Russ B. Hauser is the Frederick Lee Hisaw Professor of Reproductive Physiology and professor of environmental and occupational epidemiology in the Department of Environmental Health of the Harvard School of Public Health. He also holds an appointment at the Harvard Medical School, where he is professor of obstetrics, gynecology, and reproductive biology. Dr Hauser’s research focuses on the health risks posed by exposure to environmental chemicals that adversely affect human development and reproductive health. He has served on

Suggested Citation:"Appendix: Biosketches of the Committee to Review EPA's Draft State of the Science Paper on Nonmonotonic Dose Response." National Research Council. 2014. Review of the Environmental Protection Agency's State-of-the-Science Evaluation of Nonmonotonic Dose-Response Relationships as they Apply to Endocrine Disruptors. Washington, DC: The National Academies Press. doi: 10.17226/18608.
×

several National Research Council and Institute of Medicine committees, including the Committee on the Health Risks of Phthalates. He was chair of the Environment and Reproduction Special Interest Group of the American Society for Reproductive Medicine and serves on the US Consumer Product Safety Commission’s Chronic Hazard Advisory Panel that is examining the effects of phthalates on children’s health. He received his MD from Albert Einstein College of Medicine and his MPH and ScD from the Harvard School of Public Health. He is board-certified in occupational medicine.

Amy H. Herring is professor of biostatistics and associate chair of the Department of Biostatistics of the University of North Carolina at Chapel Hill. Her research interests include longitudinal and multivariate data, hierarchic models, latent variables, Bayesian methods, reproductive and environmental epidemiology, and maternal and child health. She is a former president of the Eastern North American Region Committee of the International Biometric Society. Dr. Herring is a fellow of the American Statistical Association and serves on the Board of Directors of the International Society for Bayesian Analysis. She received the Mortimer Spiegelman Award for outstanding public-health statistician under the age of 40 years from the American Public Health Association in 2012. Dr. Herring received her ScD in biostatistics from Harvard University.

Andreas Kortenkamp is professor of human toxicology at the Institute for the Environment of Brunel University, London (United Kingdom). His research interests are in exploring environmental pollutants and their combined effects on endocrine diseases. In numerous publications, he has investigated the effects of mixtures of chemicals that can disrupt hormone action. Dr. Kortenkamp has been involved in the development of several reports for the European Commission, including the State of the Art Report on Mixture Toxicology and the State of the Art Assessment of Endocrine Disruptors. He was a member of the World Health Organization–United Nations Environmental Programme panel for evaluating the state of the science of endocrine disruption in 2012. Dr. Kortenkamp was a member of the National Research Council Committee on the Health Risks of Phthalates and is a member of the US Consumer Product Safety Commission’s Chronic Hazard Advisory Panel that is examining the effects of phthalates on children’s health. He earned his PhD from Bremen University in Germany.

Heather B. Patisaul is an associate professor in the Department of Biology of the North Carolina State University. Her research examines the steroid-dependent mechanisms through which sexually dimorphic behaviors and brain circuits arise, and she also explores the mechanisms by which sexually dimorphic systems and behaviors can be disrupted by environmental estrogens. Her laboratory is interested in the mechanisms by which exposure to environmental estrogens can advance puberty and impair fertility in females. Dr. Patisaul served on the World Health Organization expert panel that assessed the risks of bisphenol A in 2010. She received her PhD from Emory University.

Suggested Citation:"Appendix: Biosketches of the Committee to Review EPA's Draft State of the Science Paper on Nonmonotonic Dose Response." National Research Council. 2014. Review of the Environmental Protection Agency's State-of-the-Science Evaluation of Nonmonotonic Dose-Response Relationships as they Apply to Endocrine Disruptors. Washington, DC: The National Academies Press. doi: 10.17226/18608.
×

Elizabeth N. Pearce is associate professor of medicine at the Boston University School of Medicine in the Section of Endocrinology, Diabetes, and Nutrition. Her research interests include the sufficiency of dietary iodine in the United States, thyroid function in pregnancy and lactation, thyroid effects of exposure to environmental perchlorate and other potential endocrine disruptors, and the cardiovascular effects of subclinical thyroid dysfunction. She has served as a member of the Board of Directors of the American Thyroid Association (ATA) and is on the Management Council of the International Council for the Control of Iodine Deficiency Disorders Global Network. Dr. Pearce is the recipient of ATA’s 2011 Van Meter Lecture Award. She received her MD from Harvard Medical School and her MSc in epidemiology from the Boston University School of Public Health.

Tracey J. Woodruff is professor and director of the Program on Reproductive Health and the Environment in the Department of Obstetrics, Gynecology, and Reproductive Sciences of the University of California, San Francisco. Before joining the university, she was a senior scientist at the US Environmental Protection Agency’s National Center for Environmental Economics. She has extensive expertise in exposure assessment, environmental epidemiology, risk assessment, and research translation. Her research interests are in evaluating prenatal exposures to environmental chemicals and related adverse pregnancy outcomes and characterizing developmental risks. She has also been involved in developing guidance for applying evidence-based medicine methodology to environmental health sciences. Dr. Woodruff was appointed to the California Developmental and Reproductive Toxicant Identification Committee in 2012. She received her PhD in bioengineering from a joint program of the University of California, Berkeley and San Francisco.

Lauren Zeise is deputy director for scientific affairs in the California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment. She oversees the department’s scientific activities, which include the development of risk assessments, hazard evaluations, toxicity reviews, cumulative impacts analyses, and frameworks and methods for assessing toxicity and cumulative impact and the department’s activities in the California Environmental Contaminant Biomonitoring Program. Dr. Zeise was the 2008 recipient of the Society of Risk Analysis’s Outstanding Practitioner Award. She has served on several 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 Research Council and Institute of Medicine committees, including service as a member of the Committee on Improving Risk Analysis Approaches Used by the US Environmental Protection Agency and current service on the Committee on the Review of the Formaldehyde Assessment in the National Toxicology Program 12th Report on Carcinogens. She received her PhD from Harvard University.

Suggested Citation:"Appendix: Biosketches of the Committee to Review EPA's Draft State of the Science Paper on Nonmonotonic Dose Response." National Research Council. 2014. Review of the Environmental Protection Agency's State-of-the-Science Evaluation of Nonmonotonic Dose-Response Relationships as they Apply to Endocrine Disruptors. Washington, DC: The National Academies Press. doi: 10.17226/18608.
×

Yiliang Zhu is professor in the Department of Epidemiology and Biostatistics of the University of South Florida, where he directs the Center for Collaborative Research. He is also professor of internal medicine at Morsani College of Medicine. His current research involves quantitative methods in health risk assessment, including physiologically based pharmacokinetic models, dose–response modeling, benchmark-dose methods, and uncertainty quantification. He also conducts research in health outcome and health system evaluation. Dr. Zhu is currently a Fulbright Research Fellow in China, where he is establishing a 15-year cohort study on rural health and human development in northwest China. Dr. Zhu has served on several National Research Council committees, including current service on the Committee to Review the IRIS Process. He received his PhD in statistics from the University of Toronto.

Suggested Citation:"Appendix: Biosketches of the Committee to Review EPA's Draft State of the Science Paper on Nonmonotonic Dose Response." National Research Council. 2014. Review of the Environmental Protection Agency's State-of-the-Science Evaluation of Nonmonotonic Dose-Response Relationships as they Apply to Endocrine Disruptors. Washington, DC: The National Academies Press. doi: 10.17226/18608.
×

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Suggested Citation:"Appendix: Biosketches of the Committee to Review EPA's Draft State of the Science Paper on Nonmonotonic Dose Response." National Research Council. 2014. Review of the Environmental Protection Agency's State-of-the-Science Evaluation of Nonmonotonic Dose-Response Relationships as they Apply to Endocrine Disruptors. Washington, DC: The National Academies Press. doi: 10.17226/18608.
×
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Suggested Citation:"Appendix: Biosketches of the Committee to Review EPA's Draft State of the Science Paper on Nonmonotonic Dose Response." National Research Council. 2014. Review of the Environmental Protection Agency's State-of-the-Science Evaluation of Nonmonotonic Dose-Response Relationships as they Apply to Endocrine Disruptors. Washington, DC: The National Academies Press. doi: 10.17226/18608.
×
Page 48
Suggested Citation:"Appendix: Biosketches of the Committee to Review EPA's Draft State of the Science Paper on Nonmonotonic Dose Response." National Research Council. 2014. Review of the Environmental Protection Agency's State-of-the-Science Evaluation of Nonmonotonic Dose-Response Relationships as they Apply to Endocrine Disruptors. Washington, DC: The National Academies Press. doi: 10.17226/18608.
×
Page 49
Suggested Citation:"Appendix: Biosketches of the Committee to Review EPA's Draft State of the Science Paper on Nonmonotonic Dose Response." National Research Council. 2014. Review of the Environmental Protection Agency's State-of-the-Science Evaluation of Nonmonotonic Dose-Response Relationships as they Apply to Endocrine Disruptors. Washington, DC: The National Academies Press. doi: 10.17226/18608.
×
Page 50
Suggested Citation:"Appendix: Biosketches of the Committee to Review EPA's Draft State of the Science Paper on Nonmonotonic Dose Response." National Research Council. 2014. Review of the Environmental Protection Agency's State-of-the-Science Evaluation of Nonmonotonic Dose-Response Relationships as they Apply to Endocrine Disruptors. Washington, DC: The National Academies Press. doi: 10.17226/18608.
×
Page 51
Suggested Citation:"Appendix: Biosketches of the Committee to Review EPA's Draft State of the Science Paper on Nonmonotonic Dose Response." National Research Council. 2014. Review of the Environmental Protection Agency's State-of-the-Science Evaluation of Nonmonotonic Dose-Response Relationships as they Apply to Endocrine Disruptors. Washington, DC: The National Academies Press. doi: 10.17226/18608.
×
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Review of the Environmental Protection Agency's State-of-the-Science Evaluation of Nonmonotonic Dose-Response Relationships as they Apply to Endocrine Disruptors Get This Book
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Potential health effects from chemicals that disrupt endocrine function pose an environmental health concern because of their ability to interfere with normal hormone function in human and wildlife populations. The endocrine system regulates biological processes throughout the body and is sensitive to small changes in hormone concentrations. Endocrine-disruptor research has focused primarily on chemicals that affect three hormone pathways that play important roles in reproduction and development - the estrogen, androgen, and thyroid hormone pathways. Some of this research has identified dose-response relationships that have nonmonotonic curves. Nonmonotonic dose-response curves (NMDRs) are of concern because they do not follow the usual assumption made in toxicology that as dose decreases the response also decreases.

The existence of NMDRs has been a controversial topic for decades, and there has been considerable debate about their implications for how chemicals are tested and for how risks from such chemicals are assessed. Toxicity tests are designed to identify hazards and to characterize dose-response relationships, so tests are aimed at finding a (high) dose that elicits a response, and dose-response is explored by testing lower doses spaced to identify statistically a no- or lowest-observed-adverse-effect level. The concern for NMDRs is that such studies, as currently designed, might not detect the inflection of the dose-response curve if only a few doses are tested or if the change in inflection occurs below the range of doses tested. Another concern is that some NMDRs are found for biological effects that are not usually evaluated in toxicity tests. If current testing strategies are inadequate to account for NMDRs, changes to risk assessment practices might be necessary. To help address these issues, the U.S. Environmental Protection Agency (EPA) developed a draft State-of-the-Science Evaluation: Nonmonotonic Dose Responses as they Apply to Estrogen, Androgen, and Thyroid Pathways and EPA Testing and Assessment Procedures. EPA asked the National Research Council to conduct an independent review of this evaluation to ensure that it is scientifically sound and of high quality.

Review of Environmental Protection Agency's State-of-the-Science Evaluation of Nonmonotonic Dose-Response as they Apply to Endocrine Disrupters evaluates whether EPA's evaluation presents a scientifically sound and high-quality analysis of the literature on NMDRs. This report reviews how well the EPA evaluation described how the assessment was performed, whether consistent methods and criteria were applied in the analysis of different evidence streams, and whether appropriate methods were applied to evaluating the evidence. The report makes recommendations to improve EPA's process and strengthen the evaluation.

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