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Toxicity Testing in the 21st Century: A Vision and a Strategy Appendix Biographic Information on the Committee on Toxicity Testing and Assessment of Environmental Agents Daniel Krewski (Chair) is professor of epidemiology and community medicine and director of the McLaughlin Centre for Population Health Risk Assessment at the University of Ottawa. Previously, he served as director of the Bureau of Chemical Hazards and director of risk management at Health Canada. His research interests include epidemiology, biostatistics, risk assessment, and risk management. Dr. Krewski is a member of the National Research Council (NRC) Nuclear and Radiation Studies Board and previously served on its Committee on Health Risks of Exposure to Radon (BEIR VI) and its Committee to Assess Health Risks from Exposure to Low Levels of Ionizing Radiation (BEIR VII, Phase 2). Dr. Krewski also served on the Board on Environmental Studies and Toxicology, the Committee on Research Priorities for Airborne Particulate Matter, the Committee on Grand Challenges in Environmental Science, the Committee on Comparative Toxicity of Naturally Occurring Carcinogens, the Committee on Toxi-
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Toxicity Testing in the 21st Century: A Vision and a Strategy cology (COT), the COT Subcommittee on the Health Effects of Ingested Fluoride, and the Subcommittee on Pharmacokinetics in Risk Assessment of the Safe Drinking Water Committee. Dr. Krewski chaired the Committee on Acute Exposure Guideline Levels from 1998 to 2004, and the Colloquium on Scientific Advances and the Future of Toxicologic Risk Assessment held in 1997 on the 50th anniversary of the COT. Dr. Krewski received his MSc and PhD in mathematics and statistics from Carleton University and his MHA from the University of Ottawa. Daniel Acosta, Jr. is dean of the College of Pharmacy at the University of Cincinnati. Dr. Acosta's research focuses on the development of in vitro cellular models to explore and evaluate the mechanisms by which xenobiotics damage cell types. He has worked to develop primary culture systems of liver, heart, kidney, nerve, skin, and eye cells as experimental models to study the cellular and subcellular toxicity of selected xenobiotics. He was president of the Society of Toxicology in 2000-2001 and is editor of Toxicology In Vitro and the Target Organ Series on Cardiovascular Toxicology. Dr. Acosta serves as chair of the Food and Drug Administration Scientific Advisory Board for the National Center for Toxicology Research and was a member of the Board of Scientific Councilors for the Office of Research and Development for the Environmental Protection Agency in 2001-2004. He was a member of the Scientific Advisory Committee to the director of the National Center for Environmental Health of the Centers for Disease Control and Prevention in 2001-2003. He is serving on the Scientific Advisory Committee for Alternative Toxicological Methods for the National Institute of Environmental Health Sciences and the Expert Committee on Toxicology and Biocompatibility for the US Pharmacopoeia (2000-2005). He also served on the National Research Council Howard Hughes Medical Institute Predoctoral Fellowships Panel on Neurosciences and Physiology. Dr. Acosta
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Toxicity Testing in the 21st Century: A Vision and a Strategy received his PhD in pharmacology and toxicology from the University of Kansas. Melvin Andersen is director of the Computational Biology Division at the Hamner Institutes for Health Sciences. Previously, he held positions in toxicology research and research management in the federal government (Department of Defense and Environmental Protection Agency) and was professor of environmental health at Colorado State University. He has worked to develop biologically realistic models of the uptake, distribution, metabolism, and biologic effects of drugs and toxic chemicals and has applied these physiologically based pharmacokinetic and pharmacodynamic models to safety assessments and quantitative health risk assessments. His current research interests include developing mathematical descriptions of control of genetic circuitry in the developing and adult organism and the dose-response and risk-assessment implications of the control processes. Dr. Andersen is board-certified in industrial hygiene and in toxicology. He has served on numerous National Research Council committees, including the Committee on Toxicology, the Committee on Toxicological Effects of Mercury, the Committee on Risk Assessment Methodology, and the Subcommittee on Pharmacokinetics. He earned a PhD in biochemistry and molecular biology from Cornell University. Henry Anderson is chief medical officer and state epidemiologist for occupational and environmental health in the Wisconsin Division of Public Health and adjunct professor of population health at the University of Wisconsin Medical School. Dr. Anderson's research interests include disease surveillance, risk assessment, childhood asthma, lead poisoning, health hazards of Great Lakes sport-fish consumption, arsenic in drinking water, bioterrorism, asbestos disease, vermiculite exposure, and occupational fatalities and injuries in youth. He is certified by the American Board of
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Toxicity Testing in the 21st Century: A Vision and a Strategy Preventive Medicine with a subspecialty in occupational and environmental medicine and is a fellow of the American College of Epidemiology. Dr. Anderson is chair of the Board of Scientific Councilors of the National Institute for Occupational Safety and Health and has served as chair of the Environmental Health Committee of the Environmental Protection Agency Scientific Advisory Board. He served on the National Research Council Committee on a National Agenda for the Prevention of Disabilities and Committee on Enhancing Environmental Health Content in Nursing Practice. Dr. Anderson received his MD from the University of Wisconsin Medical School. John C. Bailar III is professor emeritus in the Department of Health Studies at the University of Chicago. He is a retired commissioned officer of the U.S. Public Health Service and worked for the National Cancer Institute for 22 years. He has also held academic appointments at Harvard University and McGill University. Dr. Bailar's research interests include assessing health risks posed by chemical hazards and air pollutants and interpreting statistical evidence in medicine, with emphasis on cancer. He was editor-in-chief of the Journal of the National Cancer Institute for 6 years and was statistical consultant for and then member of the Editorial Board of the New England Journal of Medicine. Dr. Bailar is a member of the International Statistical Institute and was elected to the Institute of Medicine in 1993. He received his MD from Yale University and his PhD in statistics from American University. Kim Boekelheide is professor in the Department of Pathology and Laboratory Medicine at Brown University. His research interests are in male reproductive biology and toxicology, particularly the potential roles of germ-cell proliferation and apoptosis and local paracrine growth factors in the regulation of spermatogenesis after toxicant-induced injury. Dr. Boekelheide serves on the National Research Council Subcommittee on
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Toxicity Testing in the 21st Century: A Vision and a Strategy Fluoride in Drinking Water and has served on the Committee on Gender Differences in Susceptibility to Environmental Factors: A Priority Assessment. He is a past member of the Board of Scientific Counselors of the National Toxicology Program (NTP) and currently serves on the NTP Center for the Evaluation of Risks to Human Reproduction expert panel that is evaluating di-(2-ethylhexyl)phthalate. Dr. Boekelheide received his MD and PhD (in pathology) from Duke University and is board-certified in anatomic and clinical pathology. Robert Brent is Distinguished Professor of Pediatrics, Radiology, and Pathology at the Jefferson Medical College of Thomas Jefferson University and head of the Laboratory of Clinical and Environmental Teratology at the Alfred I. duPont Hospital for Children. Dr. Brent's research focuses on the environmental and genetic causes of congenital malformations, genetic disease, and cancer, with an emphasis on reproduction and the toxicity of drugs, physical agents, and chemicals. Dr. Brent is the author or “The Vulnerability and Resiliency of the Developing Embryo, Infant, Child and Adolescent to the Effects of Environmental Chemicals, Drugs and Physical Agents as compared to Adults” for the Environmental Protection Agency and the American Academy of Pediatrics, which was published in Pediatrics in April 2004. He is a member of the Institute of Medicine. Dr. Brent received his MD with honors; a PhD in embryology, radiation biology, and physics; and an honorary DSc—all from the University of Rochester. Gail Charnley is principal of HealthRisk Strategies, her consulting practice in Washington, DC. Her interests are toxicology, environmental health risk assessment, and risk-management science and policy. She was executive director of the Presidential/Congressional Commission on Risk Assessment and Risk Management, mandated by Congress to evaluate the role that risk
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Toxicity Testing in the 21st Century: A Vision and a Strategy assessment and risk management play in federal regulatory programs. Before her appointment to the commission, she served as director of the toxicology and risk-assessment program at the National Academies. She has been the project director for several National Research Council (NRC) committees, including the Committee on Risk Assessment Methodology and the Complex Mixtures Committee, and served as the chair of several U.S. Army Science Advisory Board committees that evaluated health risk assessment. Dr. Charnley serves on the NRC Committee on Improving Practices for Regulating and Managing Low-Activity Radioactive Waste. She received her PhD in toxicology from the Massachusetts Institute of Technology. Vivian G. Cheung is associate professor in the Department of Pediatrics and Genetics at the University of Pennsylvania School of Medicine and a member of the Cell and Molecular Biology and Genomics and Computational Biology Graduate Groups. Her primary research interests include human-genome variation, DNA-damage repair, and the use of genomewide approaches to study the genetic basis of human phenotypes and traits. Her research techniques include genomic-mismatch scanning, sequence-mismatch detection, physical mapping, molecular fingerprinting, DNA microarrays, fluorescent image analysis, and developing genome databases. She earned her MD from Tufts University. Sidney Green, Jr. is graduate professor of pharmacology at Howard University College of Medicine. Dr. Green's research interests include tissue culture, scientific and policy issues associated with alternatives, use of animals in toxicology, and mutagenic assay systems. He has served on the editorial boards of several scientific journals, and he is a fellow of the Academy of Toxicological Sciences. Dr. Green is a member of the National Research Council (NRC) Committee on Toxicology and has served on several NRC panels, including the Subcommittee on Acute Exposure Guideline
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Toxicity Testing in the 21st Century: A Vision and a Strategy Levels, the Subcommittee on the Toxicity of Diisopropyl Methylphosphonate, and the Subcommittee on Iodotrifluoromethane. He received his PhD in biochemical pharmacology from Howard University. Karl T. Kelsey is professor of cancer biology and environmental health in the Departments of Genetics and Complex Diseases and Environmental Health at the Harvard School of Public Health. Dr. Kelsey’s research interests are in occupational and environmental disease, including susceptibility to disease, with emphasis on gene-environment interactions in the production of chronic disease, and the determinants of somatic gene inactivation in lung and upper airway cancers. He has been at the Harvard School of Public Health since 1987. Dr. Kelsey has served on numerous National Research Council committees, including the Committee on Copper in Drinking Water, the Committee to Review the Health Consequences of Service during the Persian Gulf War, and the Committee on the Health Effects of Mustard Gas and Lewisite. Dr. Kelsey received his MD from the University of Minnesota and an MOH from Harvard University. Nancy I. Kerkvliet is a professor in the Department of Environmental and Molecular Toxicology at Oregon State University (OSU). Dr. Kerkvliet also serves as the associate director of the Environmental Health Sciences Center at OSU and director of the Flow Cytometry and Cell Sorting Facilities Core. Her research interests include the use of animal models to understand how chemicals alter immune function, particularly the mechanisms of action of polychlorinated dibenzo-p-dioxins and other aryl hydrocarbon receptor (AhR) ligands. Transgenic and gene-deletion approaches are being used, as well as genomics, to address mechanisms of AhR-mediated immunotoxicity. She is also active in public-outreach education programs in toxicology and risk communication. Dr. Kerkvliet is a member of the Institute of Medicine
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Toxicity Testing in the 21st Century: A Vision and a Strategy Committee to Review the Health Effects in Vietnam Veterans of Exposure to Herbicides and is a past member of the National Research Council Committee on Toxicology. She has also served as a councilor for the Society of Toxicology. She earned her PhD in interdisciplinary biologic sciences and toxicology from OSU. Abby A. Li recently joined Exponent, Inc. as a managing scientist-toxicologist in the health risk and food and chemical practices. Her fields of research include toxicology, neurotoxicology, developmental neurotoxicology, psychopharmacology, risk assessment, and pesticide regulation. Previously, Dr. Li was a senior science fellow and a global regulatory science manager at Monsanto, providing expertise in toxicology and risk assessment to address regulatory scientific issues in different world areas. For more than 10 years, she led the neurotoxicology group at Monsanto's Environmental Health Laboratory, where she conducted pharmacokinetic, toxicology, and neurotoxicology studies of industrial chemicals, agricultural products, and pharmaceuticals. Dr. Li served on the U.S. expert teams to the Organisation for Economic Co-operation and Development for the development of international test guidelines for adult and developmental neurotoxicology and as chair of neurotoxicology expert groups for industry trade organizations (the American Chemistry Council’s long-range research program and the American Industrial Health Council) addressing scientific regulatory issues in neurotoxicology. Dr. Li was a member of the Environmental Protection Agency Science Advisory Board's Environmental Health Committee for 6 years, reviewing the lead rule, 1,3-butadiene risk assessment, trichloroethylene risk assessment, cancer guidelines, the IRIS database, development of acute reference exposure, methods for derivation of inhalation reference concentrations, and indoor-air toxics priority ranking. She is a member of the International Life Science Institute Agricultural Chemical Safety Assessment panel involved in
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Toxicity Testing in the 21st Century: A Vision and a Strategy redesign of safety assessment of pesticides. She received her PhD in pharmacology and physiology from the University of Chicago. Lawrence McCray teaches at the Massachusetts Institute of Technology (MIT), where he leads a project on the use of knowledge in decision-making and participates in other research on organizational performance and behavior in risk management. Dr. McCray was a staff director and a senior manager at the National Research Council, where he led many studies on U.S. science and technology policy programs, including the study Risk Assessment in the Federal Government: Managing the Process, the so-called Red Book. Dr. McCray also served as head of the Environmental Protection Agency Regulatory Reform Unit and as a program director on regulatory reform in the Executive Office of the President. He earned a PhD in science and public policy from MIT and an MBA from Union College. Otto Meyer is head of the Section of Biology, Department of Toxicology and Risk Assessment, the National Food Institute, Technical University of Denmark. The section has overall responsibility for in vivo testing in the department, including repeated dose-toxicity studies, carcinogenicity studies, reproductive-toxicity studies, and neurotoxicity studies. He is the specialized expert to the European Economic Community on classification and labeling of dangerous substances with carcinogenic, mutagenic, or teratogenic properties and national coordinator of the Test Guideline Programme (human health) of the Organisation for Economic Co-operation and Development (OECD). Concerning the latter commitment, Dr. Meyer is a member of the group preparing an OECD guidance document on reproductive toxicity and assessment. During the last 5 years, he has served as a member of the European Union Scientific Committee on Plant Protection Products (now named the Panel of Plant Health), Plant Protection and their Residues under the European Food Safety Authority. Dr. Meyer
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Toxicity Testing in the 21st Century: A Vision and a Strategy earned a DVM from the Royal Veterinary and Agricultural University in Copenhagen. D. Reid Patterson retired in 2003 after almost 20 years of responsibility for the toxicity and safety assessment of the diverse portfolio of pharmaceutical, diagnostic, and hospital products for Abbott Laboratories; he is now a private consultant. During his tenure, he led the research efforts in toxicology, pathology, laboratory animal medicine, metabolism, pharmacokinetics, and analytic chemistry in an effort to characterize product hazards. Environmental toxicity was a greater focus during his earlier years in the petrochemical industry (Shell) and the contract laboratory business (Hazleton). Dr. Patterson is a veterinarian with residency training in laboratory animal medicine, and he received his PhD in comparative pathology from the University of Missouri. He is board-certified in laboratory animal medicine, veterinary pathology, and general toxicology, and he is a fellow of the Academy of Toxicological Sciences and the International Academy of Toxicologic Pathology. William Pennie is research-site lead for drug safety at Pfizer’s Connecticut laboratories. Dr. Pennie’s research interests began with the molecular biology of the estrogen receptor, particularly differential transcriptional regulation by estrogen-receptor subtypes. More recently, his interests have included global receptor biology, improving the predictivity of investigative techniques used at early stages of product development, the technology and application of custom microarray toxicogenomics platforms, and the application of state-of-the-art molecular profiling techniques to research and investigative toxicology. He chaired the International Life Sciences Institute Health and Environmental Sciences Institute (ILSI HESI) Committee on the Application of Genomics to Mechanism-Based Risk Assessment from 2002 to 2004. Dr. Pen-
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Toxicity Testing in the 21st Century: A Vision and a Strategy nie received his PhD from the Beatson Institute for Cancer Research at the University of Glasgow, Scotland. Robert A. Scala is former senior scientific adviser at Exxon Biomedical Sciences Inc. He is also an adjunct professor of toxicology at Rutgers University. He is well known for his work on the toxicity of gasoline components and chemical mixtures. He is a past president of the Society of Toxicology and the American Board of Toxicology. He has published in chronic toxicity testing and evaluation of alternative test protocols and data. Dr. Scala has served on several National Research Council committees, including the Committee on Environmental Justice: Research, Education, and Health Policy Needs, the Committee on Lead Toxicity, and the Committee on Methods for In Vivo Toxicity Testing of Complex Mixtures from the Environment. Dr. Scala earned his PhD in physiology from the University of Rochester School of Medicine and Dentistry. Gina M. Solomon is a senior scientist at the Natural Resources Defense Council and an associate clinical professor of medicine at the University of California, San Francisco (UCSF), where she is also the associate director of the UCSF Pediatric Environmental Health Specialty Unit. Her work has included research on asthma, pesticides, and environmental and occupational threats to reproductive health and child development. Dr. Solomon serves on the Environmental Protection Agency Science Advisory Board Drinking Water Committee and previously served on the Endocrine Disruptor Screening and Testing Advisory Committee. Dr. Solomon received her MD from Yale University and underwent her postgraduate training in medicine and public health at Harvard University. Martin Stephens is vice president of the Animal Research Issues Section of the Humane Society of the United States. Dr. Stephens
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Toxicity Testing in the 21st Century: A Vision and a Strategy serves as coordinator of the International Council for Animal Protection at the Organisation for Economic Co-operations and Development. He also serves on the Scientific Advisory Committee on Alternative Toxicological Methods for the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods and on the Scientific Advisory Panel of the Institute for In Vitro Sciences. Dr. Stephens has extensive experience in animal protection and in vitro testing sciences. He earned a PhD in biology from the University of Chicago. James Yager is professor of toxicology in the Department of Environmental Health Sciences, director of the National Institute of Environmental Health Sciences Training Program in Environmental Health Sciences, and senior associate dean for academic affairs at the Johns Hopkins University Bloomberg School of Public Health. Dr. Yager is a member and a past president of the carcinogenesis specialty section of the Society of Toxicology. His research focuses on the role of catechol metabolites of endogenous, synthetic, and environmental estrogens and polymorphisms in genes involved in estrogen metabolism as risk factors in the development of cancer of the breast and liver. Dr. Yager earned his PhD from the University of Connecticut. Lauren Zeise is chief of the Reproductive and Cancer Hazard Assessment Branch of the California Environmental Protection Agency. Dr. Zeise’s research focuses on modeling human interindividual variability and risk. She has served on advisory boards of the U.S. Environmental Protection Agency (EPA), the World Health Organization, the Office of Technology and Assessment, and the National Institute of Environmental Health Sciences. She has also served on several National Research Council committees, including the Committee on Risk Characterization, the Committee on Comparative Toxicology of Naturally Occurring Carcinogens, the Committee on Copper in Drinking Water, and the Committee
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Toxicity Testing in the 21st Century: A Vision and a Strategy to Review EPA’s Research Grants Program. Dr. Zeise is a member of the Board on Environmental Studies and Toxicology. She received her PhD from Harvard University.
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