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Review of EPA's Integrated Risk Information System (IRIS) Process (2014)

Chapter: Appendix A: Biographic Information on the Committee to Review the IRIS Process

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Suggested Citation:"Appendix A: Biographic Information on the Committee to Review the IRIS Process." National Research Council. 2014. Review of EPA's Integrated Risk Information System (IRIS) Process. Washington, DC: The National Academies Press. doi: 10.17226/18764.
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Appendix A

Biographic Information on the Committee to Review the IRIS Process

Jonathan M. Samet (Chair) is a pulmonary physician and epidemiologist. He is a professor and the Flora L. Thornton Chair of the Department of Preventive Medicine of the Keck School of Medicine of the University of Southern California (USC) and director of the USC Institute for Global 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 Science Advisory Board; committees of the National Research Council (NRC), including chairing the Biological Effects of Ionizing Radiation 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 Develop a Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials, and the Board on Environmental Studies and Toxicology; the National Cancer Advisory Board; and committees of the Institute of Medicine (IOM). He is a member of IOM. Dr. Samet received his MD from the University of Rochester, School of Medicine and Dentistry.

Scott Bartell is associate professor in public health, statistics, and epidemiology at the University of California, Irvine. His research interest is in environmental-health methodology with applications in environmental epidemiology, exposure science, and risk assessment. His recent projects include epidemiologic analysis of particulate-matter exposure and arrhythmia in the Cardiovascular Health and Air Pollution Study, linkage of fate and transport models and a pharmacokinetic model for perfluorooctanoic acid with data from the C8 Health Project, and development of statistical methods for biomarker-based exposure estimation and for epidemiologic analysis of aggregated data. He has served on a variety of scientific advisory committees for the National Research Council, the Environmental Protection Agency, the Centers for Disease Control and Prevention, the National Institute of Environmental Health Sciences, and the Department of Energy. Dr. Bartell earned a PhD in epidemiology and an MS in statistics from the University of California, Davis and an MS in environmental health from the University of Washington.

Lisa Bero is a professor in the Department of Clinical Pharmacy and Institute for Health Policy Studies of the University of California, San Francisco. She is also the director of the San Francisco Branch of the United States Cochrane Center. Her research interests include methods for meta-analysis and critical appraisal of research, academic–industry relations, pharmaceutical outcomes assessment, pharmacology, tobacco-control policy, and translation of research into policy. Dr. Bero is a member of the World Health Organization Guideline Review Committee and the Advisory Committee on Health Research of the Pan American Health Organization. In addition, she is a member of the Institute of Medicine Board on Health Care Services. Dr. Bero received a PhD in pharmacology and toxicology from Duke University.

Suggested Citation:"Appendix A: Biographic Information on the Committee to Review the IRIS Process." National Research Council. 2014. Review of EPA's Integrated Risk Information System (IRIS) Process. Washington, DC: The National Academies Press. doi: 10.17226/18764.
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Ann Bostrom is the Weyerhaeuser endowed professor of environmental policy at the Daniel J. Evans School of Public Affairs of the University of Washington. Her research focuses on risk perception, communication, and management and on environmental policy and decision-making under uncertainty. She serves as an associate editor or a risk-communication editor for Journal of Risk Research and the journal Human and Ecological Risk Assessment and is on the editorial board of Risk Analysis. Dr. Bostrom is an elected fellow of the American Association for the Advancement of Science and past president and an elected fellow of the Society for Risk Analysis. She has served on several National Research Council committees, including the Committee on Use of Emerging Science for Environmental Health Decisions. Dr. Bostrom received a PhD in public-policy analysis from Carnegie Mellon University.

Kay Dickersin is a professor and director of clinical trials at the Johns Hopkins Bloomberg School of Public Health. Her major research interests are related to randomized clinical trials, trial registers, systematic reviews and meta-analysis, publication bias, peer review, evidence-based health care, and comparative-effectiveness research. Dr. Dickersin has also conducted studies in such fields as women’s health, eyes and vision, and surgery. She is director of the US Cochrane Center, one of 14 centers worldwide participating in the Cochrane Collaboration, which aims to help people to make well-informed decisions about health by preparing, maintaining, and promoting the accessibility of systematic reviews of available evidence on the benefits and risks associated with health care. She has served as a member of several National Research Council committees and is a member of the Institute of Medicine. Dr. Dickersin received a PhD in epidemiology from the Johns Hopkins University School of Hygiene and Public Health.

David C. Dorman is a professor of toxicology in the Department of Molecular Biosciences of North Carolina State University. The primary objective of his research is to provide a refined understanding of chemically induced neurotoxicity in laboratory animals that will lead to improved assessment of potential neurotoxicity in humans. Dr. Dorman’s research interests include neurotoxicology, nasal toxicology, pharmacokinetics, and cognition and olfaction in military working dogs. He served as a member of the National Research Council Committee on Animal Models for Testing Interventions Against Aerosolized Bioterrorism Agents, as chair of the Committee on Emergency and Continuous Exposure Guidance Levels for Selected Submarine Contaminants and of the Committee to Evaluate Potential Health Risks from Recurrent Lead Exposure of DOD Firing Range Personnel, and as a member of the Committee to Review EPA’s Draft IRIS Assessment of Formaldehyde. He received his DVM from Colorado State University. He completed a combined PhD and residency program in toxicology at the University of Illinois at Urbana-Champaign and is a diplomate of the American Board of Veterinary Toxicology and the American Board of Toxicology.

David L. Eaton is a professor of environmental and occupational health sciences and dean and vice provost of the graduate school at the University of Washington (UW). He also serves as the director of the National Institute of Environmental Health Sciences Center for Ecogenetics and Environmental Health at UW. He has held several other UW positions, including toxicology program director in and associate chairman of the Department of Environmental Health and associate dean for research in the School of Public Health. Dr. Eaton maintains an active research and teaching program that is focused on the molecular basis of environmental causes of cancer and how human genetic differences in biotransformation enzymes may increase or decrease individual susceptibility to chemicals in the environment. He has published over 150 scientific articles and book chapters in toxicology and risk assessment. Nationally, he has served on the Board of Directors and as treasurer of the American Board of Toxicology, as secretary and later as president of the Society of Toxicology, as a member of the Board of Directors and as vice-president

Suggested Citation:"Appendix A: Biographic Information on the Committee to Review the IRIS Process." National Research Council. 2014. Review of EPA's Integrated Risk Information System (IRIS) Process. Washington, DC: The National Academies Press. doi: 10.17226/18764.
×

of the Toxicology Education Foundation, and as a member of the Board of Trustees of the Academy of Toxicological Sciences. Dr. Eaton is a member of the Institute of Medicine and has served on several National Research Council committees. He is an elected fellow of the American Association for the Advancement of Science and the Academy of Toxicological Sciences. Dr. Eaton earned a PhD in pharmacology from the University of Kansas Medical Center.

Joe G. Garcia is a professor of medicine and the senior vice president for health sciences at the Arizona Health Sciences Center of the University of Arizona. He is internationally recognized for his expertise in the genetic basis of lung disease and the prevention of and treatment for inflammatory lung injury. Dr. Garcia’s research focuses on understanding the biochemical and molecular basis of lung inflammation, especially vascular leak, in which blood cells and fluid escape from small vessels and cause edema in the surrounding tissues, especially the lungs. He is a past president of the Central Society for Clinical Research and a member of the Board of Directors of the American Thoracic Society and has been a member or chairman of several committees of the National Institutes of Health. In addition, Dr. Garcia is a member of the Institute of Medicine, the Association of American Physicians, and the American Society of Clinical Investigation. He received an MD from the University of Texas Southwestern Medical Center.

Miguel Hernán is a professor of epidemiology and biostatistics at the Harvard University School of Public Health and affiliated faculty at the Harvard-MIT Division of Health Sciences and Technology. His research is focused on methods for causal inference, including comparative effectiveness of policy and clinical interventions. Dr. Hernán and his collaborators combine observational data, mostly untestable assumptions, and statistical methods to emulate hypothetical randomized experiments. His research group emphasizes the need to formulate well-defined causal questions and the use of analytic approaches whose validity does not require assumptions that conflict with current subject-matter knowledge. Dr. Hernán is an editor of the journal Epidemiology and has served on the Institute of Medicine Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs. He received an MD from the Universidad Autónoma de Madrid in Spain.

James S. House is Angus Campbell Distinguished University Professor of Survey Research, Public Policy, and Sociology at the University of Michigan. His research interests include social psychology, political sociology, social structure and personality, psychosocial and socioeconomic factors in health, and survey research methods. Dr. House has worked in sociology and social epidemiology to understand the effects of broader social structures and processes on people’s attitudes, behavior, well-being, and especially health. His and his colleagues’ research has helped to demonstrate the adverse effects of occupational and other forms of stress on health and how social relationships and supports can buffer or mitigate the deleterious health effects of stress and promote health more generally. Over the last 2 decades he has focused on describing and understanding social disparities in health over time and the life course, especially as related to socioeconomic position. Dr. House is a member of the American Academy of Arts and Sciences, the National Academy of Sciences, and the Institute of Medicine. He has served on the National Research Council Panel on Race, Ethnicity, and Health in Later Life. Dr. House received a PhD in social psychology from the University of Michigan.

Margaret M. MacDonell is a program manager in the Environmental Science Division of Argonne National Laboratory. She conducts integrated environmental health analyses, primarily for federal agencies. She has professional interests in cumulative impact and risk; integrated environmental fate, exposure, and health-effects analyses on multiple stressors, including chemical mixtures, nanomaterials, and other hazards, such as ones related to energy development; integrated impact analyses of sustainability; and community involvement in environmental health protection. Dr. MacDonell developed risk training workshops for environmental managers and

Suggested Citation:"Appendix A: Biographic Information on the Committee to Review the IRIS Process." National Research Council. 2014. Review of EPA's Integrated Risk Information System (IRIS) Process. Washington, DC: The National Academies Press. doi: 10.17226/18764.
×

practitioners, including people in state agencies and tribal nations. She collaborated with the Environmental Protection Agency National Homeland Security Research Center to develop acute and short-term exposure advisories for chemical, radiologic, and biologic contaminants released into drinking water and buildings. She serves on two National Research Council committees: the Committee on Toxicology and the Committee on Acute Exposure Guideline Levels. Dr. MacDonell received a PhD in environmental health engineering from Northwestern University.

Richard P. Scheines is a professor and the head of philosophy at Carnegie Mellon University. His research focuses on causal discovery, specifically the problem of learning about causation from statistical evidence. Dr. Scheines also works in building and researching the effectiveness of educational software, ranging from intelligent-proof tutors to virtual-causality laboratories to a full-semester course on causal and statistical reasoning. Because of that work, he has a courtesy appointment in the Human-Computer Interaction Institute of Carnegie Mellon. He served as a member of the National Research Council Committee on Evaluation of the Presumptive Disability Decision-Making Process for Veterans and the Committee on Food Marketing and the Diets of Children and Youth. Dr. Scheines received a PhD in the history and philosophy of science from the University of Pittsburgh.

Leonard M. Siegel is director of the Center for Public Environmental Oversight, a project of the Pacific Studies Center that facilitates public participation in the oversight of military environmental programs, federal facilities cleanup, and brownfield revitalization. He is one of the environmental movement’s leading experts in military-facility contamination, community oversight of cleanup, and the vapor-intrusion pathway. For his organization, he runs two Internet newsgroups: the Military Environmental Forum and the Brownfields Internet Forum. He is a member of the Interstate Technology and Regulatory Council Munitions Response Work Team, the California Department of Toxic Substances Control External Advisory Group, and the Moffett Field (formerly Moffett Naval Air Station) Restoration Advisory Board. He has served on several committees of the National Research Council, currently as a member of the Committee on the Future Options for Management in the Nation’s Subsurface Remediation Effort. Mr. Siegel studied physics at Stanford University.

Robert B. Wallace is a professor in and director of the Center on Aging in the Departments of Epidemiology and Internal Medicine of the University of Iowa. His research interests include the epidemiology and prevention of aging-related chronic conditions, such as disabling illnesses of older persons, including arthritis, cancer, cardiovascular diseases, and dementia; clinical trials; disease prevention; epidemiology; health promotion; preventive medicine; and public health. Dr. Wallace is a member of the Institute of Medicine (IOM), chairs the IOM Board on the Health of Select Populations, and has been a member or chair of numerous IOM committees. Dr. Wallace received an MD from Northwestern University.

Yiliang Zhu is a professor in the Department of Epidemiology and Biostatistics of the University of South Florida College of Public Health. He is also director of the college’s Center for Collaborative Research. His current research is focused on quantitative methods in health risk assessment, including modeling of biologic systems via pharmacokinetics and pharmacodynamics, dose-response modeling, benchmark-dose methods, and uncertainty quantification. He also conducts research in disease surveillance, health-outcome evaluation, and impact assessment of health-care systems and policies in rural China. Dr. Zhu was a member of the National Research Council Committee on EPA’s Exposure and Human Health Assessment of Dioxin and Related Compounds, Committee on Tetrachloroethylene, and Committee to Review EPA’s Draft IRIS Assessment of Formaldehyde. He received a PhD in statistics from the University of Toronto.

Suggested Citation:"Appendix A: Biographic Information on the Committee to Review the IRIS Process." National Research Council. 2014. Review of EPA's Integrated Risk Information System (IRIS) Process. Washington, DC: The National Academies Press. doi: 10.17226/18764.
×
Page 140
Suggested Citation:"Appendix A: Biographic Information on the Committee to Review the IRIS Process." National Research Council. 2014. Review of EPA's Integrated Risk Information System (IRIS) Process. Washington, DC: The National Academies Press. doi: 10.17226/18764.
×
Page 141
Suggested Citation:"Appendix A: Biographic Information on the Committee to Review the IRIS Process." National Research Council. 2014. Review of EPA's Integrated Risk Information System (IRIS) Process. Washington, DC: The National Academies Press. doi: 10.17226/18764.
×
Page 142
Suggested Citation:"Appendix A: Biographic Information on the Committee to Review the IRIS Process." National Research Council. 2014. Review of EPA's Integrated Risk Information System (IRIS) Process. Washington, DC: The National Academies Press. doi: 10.17226/18764.
×
Page 143
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 Review of EPA's Integrated Risk Information System (IRIS) Process
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The Integrated Risk Information System (IRIS) is a program within the US Environmental Protection Agency (EPA) that is responsible for developing toxicologic assessments of environmental contaminants. An IRIS assessment contains hazard identifications and dose-response assessments of various chemicals related to cancer and noncancer outcomes. Although the program was created to increase consistency among toxicologic assessments within the agency, federal, state, and international agencies and other organizations have come to rely on IRIS assessments for setting regulatory standards, establishing exposure guidelines, and estimating risks to exposed populations. Over the last decade, the National Research Council (NRC) has been asked to review some of the more complex and challenging IRIS assessments, including those of formaldehyde, dioxin, and tetrachloroethylene. In 2011, an NRC committee released its review of the IRIS formaldehyde assessment. Like other NRC committees that had reviewed IRIS assessments, the formaldehyde committee identified deficiencies in the specific assessment and more broadly in some of EPA's general approaches and specific methods. Although the committee focused on evaluating the IRIS formaldehyde assessment, it provided suggestions for improving the IRIS process and a roadmap for its revision in case EPA decided to move forward with changes to the process. Congress directed EPA to implement the report's recommendations and then asked the National Research Council to review the changes that EPA was making (or proposing to make) in response to the recommendations.

Review of EPA's Integrated Risk Information System (IRIS) Process provides an overview of some general issues associated with IRIS assessments. This report then addresses evidence identification and evaluation for IRIS assessments and discusses evidence integration for hazard evaluation and methods for calculating reference values and unit risks. The report makes recommendations and considerations for future directions. Overall, Review of EPA's Integrated Risk Information System Process finds that substantial improvements in the IRIS process have been made, and it is clear that EPA has embraced and is acting on the recommendations in the NRC formaldehyde report. The recommendations of this report should be seen as building on the progress that EPA has already made.

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