Symposium on Toxicity Pathway-Based Risk Assessment





                            SYMPOSIUM ON
  TOXICITY PATHWAY-BASED RISK ASSESSMENT:
             Preparing for Paradigm Change



May 11-13, 2009
The National Academy of Sciences
2101 Constitution Avenue, NW
Washington, DC

Overview
Planning Committee Membership


  Symposium Program Book
  Speaker Presentations






OVERVIEW

In 2007, the National Research Council released a report entitled Toxicity Testing in the 21st Century: a Vision and a Strategy. That report proposed a new paradigm for toxicity testing that envisions evaluation of biologically significant perturbations in key toxicity pathways using new methods in computational biology and a comprehensive array of in vitro tests based on human biology. The new paradigm was developed to provide broad coverage of chemicals, mixtures, outcomes, and life stages; to reduce the numbers of animals used in testing and the cost and time associated with testing; and to develop a more robust scientific basis for assessing health effects of environmental agents.

The revolution in toxicity testing is underway, influenced and stimulated by a variety of pressures. It is estimated that over 30,000 chemicals will be registered under the extensive new data requirements of the European Registration, Evaluation, and Authorization of Chemicals (REACH) program. Because of the large influx of new data and because of market forces and international agreements, the U.S. Environmental Protection Agency (EPA) must be prepared to interpret these new data to support priority setting and use in risk assessments. Thus, a workshop to stimulate discussion on the application of new approaches in risk assessment was considered appropriate.

An ad hoc committee under the oversight of the Standing Committee on Risk Analysis Issues and Reviews is planning a 2-3 day public workshop on the application to risk assessment of new pathway-based approaches, such as those envisioned in the 2007 National Research Council report Toxicity Testing in the 21st Century: a Vision and a Strategy. The workshop will include plenary sessions, during which new toxicity-testing approaches and case examples will be presented to address the use of various types of data in risk assessment. The workshop will also incorporate a poster session to provide additional information in support of the case studies and to highlight examples of how new technologies may be applied to qualitative and quantitative aspects of risk assessment.
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PLANNING COMMITTEE MEMBERSHIP

Lorenz Rhomberg, chair, is a principal with Gradient Corporation, an environmental sciences consulting firm. He is an expert in quantitative risk assessment, including dose-response analysis, pharmacokinetic modeling, and probabilistic methods, with special experience in chlorinated solvents. His focus includes science policy and methodology for human health risk assessment, including approaches to weight of toxicological evidence for human hazard and cross-species extrapolation. Before joining Gradient, Dr. Rhomberg was on the faculty of the Harvard School of Public Health and also worked at the U.S. Environmental Protection Agency. Dr. Rhomberg is active in professional groups and environmental policy development, focusing on current issues in the interpretation of toxicological data in human health risk assessment through service on panels sponsored by government, industry, and such organizations as the International Life Sciences Institute. He has served on several National Research Council committees, including the Committee on Assuring the Safety of the Defense Department's Mail, the Committee on Testing and Evaluation of Standoff Chemical Agent Detectors, and the Subcommittee on Manufactured Vitreous Fibers, and he is currently a member of the Standing Committee on Risk Analysis Issues and Reviews . Dr. Rhomberg earned his PhD in population biology from the State University of New York at Stony Brook.
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Elaine Faustman is a professor of environmental and occupational health sciences at the University of Washington School of Public Health and Community Medicine and directs the Institute for Risk Analysis and Risk Communication. Her research interests include understanding mechanisms of developmental and reproductive toxicants, characterizing in vitro techniques for developmental toxicology assessment, and developing biologically based dose-response models for noncancer risk assessment. Her research expertise includes the development of tools for incorporating new scientific findings into risk assessment decisions. Dr. Faustman is an elected fellow of the American Association for the Advancement of Science and the Society for Risk Analysis. She has also been involved in several National Research Council committees, including the Committee on Spacecraft Exposure Guidelines, the Committee on Developmental Toxicology, and the Committee on Toxicology. Dr. Faustman received a PhD in toxicology from Michigan State University.
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Lynn Goldman is a pediatrician, an epidemiologist, and a professor at the Johns Hopkins University Bloomberg School of Public Health, where her areas of focus are environmental health policy, public health practice, and children's environmental health. Dr. Goldman previously served as the assistant administrator for the U.S. Environmental Protection Agency (EPA) Office of Prevention, Pesticides and Toxic Substances (OPPTS). During her tenure at EPA, Dr. Goldman was responsible for the nation's pesticide, toxic substances, and pollution prevention laws, and she was successful in promoting children's health issues and furthering the international agenda for global chemical safety. Prior to joining EPA, Dr. Goldman served in several positions at the California Department of Health Services, including head of the Division of Environmental and Occupational Disease Control. She has served on numerous boards and expert committees, including the Committee on Environmental Health of the American Academy of Pediatrics and the Centers for Disease Control Lead Poisoning Prevention Advisory Committee. She has also served as a member of numerous National Research Council (NRC) committees, including the Committee on Identifying and Assessing Unintended Effects of Genetically Engineered Foods on Human Health, the Committee on Clinical Trial Registries, and the Committee to Evaluate the Hazardous Materials Management Program of the Bureau of Land Management. She currently is vice chair of the Institute of Medicine (IOM) Roundtable on Environmental Health Sciences, chair of the IOM Committee on Secondhand Smoke Exposure and Acute Cornonary Events, and a member of the NRC Standing Committee on Risk Analysis Issues and Reviews. Dr. Goldman received her MD from the University of California, San Francisco.
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Michael Lawton is an associate research fellow and head of the Molecular Toxicology Group at Pfizer in Groton, CT. His molecular toxicology lab applies molecular approaches in support of predictive toxicology, identifies molecular biomarkers, and investigates mechanistic toxicology for early- and late-stage safety assessment. Dr. Lawton participates in the Vascular Injury Working Group of the external Predicative Safety Testing Consortium and also supports the Internal Hepatic and Vascular Injury Project teams. He is also the principal investigator for several external technology collaborations. He is a member of the Society of Toxicology (SOT) and councilor of the Drug Discovery Toxicology Specialty Section of SOT. Dr. Lawton received a PhD in toxicology from North Carolina State University.
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George Leikauf is a professor in the department of environmental and occupational health at the University of Pittsburgh. His research investigates the functional genomics of acute lung injury, asthma, and chronic obstructive pulmonary disease. He is interested in uncovering the genetic basis of increased susceptibility to pulmonary epithelial injury and repair, as well as examining the transcriptional regulation of molecular targets. Dr. Leikauf has served on numerous national and international committees, including the National Institutes of Health's National Advisory Environmental Health Sciences Council and Center for Scientific Review Advisory Committee, the American Physiological Society's Perkins Memorial Fund Committee, the American Thoracic Society's Perkins Memorial Fund Committee, the American Thoracic Society's Program Committee, and the International Advisory Committee for the 8th and 9th Inhalation Symposium. He has also served as a member of the National Research Council Committee on Applications of Toxicogenomics Technologies to Predictive Toxicology. Dr. Leikauf received a PhD in environmental health sciences from the New York University Medical Center.
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Joel Pounds is a senior staff scientist in cell biology and biochemistry of the Biological Sciences Division and science advisor to the Environmental Biomarkers Initiative at the Pacific Northwest National Laboratory (PNNL) and director of the NIH funded Center for Novel Biomarkers of Response Genes (Genes and Environment Initiative, Exposure Biology Program). Dr. Pounds has directed research programs in government (National Center for Toxicological Research, 1977-1985), national laboratories (Brookhaven National Laboratory, 1985-1990), and academia (Wayne State University, 1990-1999). His current research includes the use of mass-spectrometry based proteomic and NMR-based metabonomic instrumentation for characterization of biological responses of pulmonary disease in humans and in experimental animals, including response to engineered nanomaterials. Dr. Pounds received a PhD in environmental toxicology from the University of Wisconsin.
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Joyce Tsuji is a Principal with Exponent's Health Sciences practice and is a board-certified toxicologist and Fellow of the Academy of Toxicological Sciences. She has over 20 years of experience in toxicology and risk assessment on projects in the United States and internationally for corporations, trade associations, regulatory agencies, and state and local municipalities. Particular areas of interest include exposure assessment and the toxicology of a variety of chemicals including those from industrial releases and in consumer products. She also has specific experience in design and direction of exposure studies involving health education, environmental sampling, and biomonitoring of populations potentially exposed to chemicals in soil, water, and the food chain. Dr. Tsuji has served on expert committees for the National Academy of Sciences/National Research Council (NAS/NRC), U.S. EPA, U.S. Army, and the State of Washington. In addition to the Standing Committee on Risk Analysis and Issue, her service on NRC committees has included Copper in Drinking Water, Spacecraft Exposure Guidelines, Emergency and Continuous Exposure Guidance Levels for Selected Submarine Contaminants, and Submarine Escape Action Levels. She received a Ph.D. with focus in physiology and ecology from the Department of Zoology of the University of Washington.
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Lauren Zeise is chief of the Reproductive and Cancer Hazard Assessment Branch of the California Environmental Protection Agency. She oversees a variety of risk assessment activities, including development of approaches for assessing cumulative impacts, nanotechnology, green chemisty/safter alternatives, susceptible populations; cancer and reproductive toxicant assessments; health risk characterizations for environmental media, food, and consumer products; and her department's biomonitoring activities. Dr. Zeise has served on advisory boards of the U.S. Environmental Protection Agency (EPA), the World Health Organization, the Office of Technology Assessment, and the National Institute of Environmental Health Sciences. She has also served on the National Research Council (NRC) Board on Environmental Studies and Toxicology, the Institute of Medicine Board of Health Promotion and Disease Prevention and Committee on Evaluation of Presumptive Disability Decision-Making Process for Veterans, and several NRC committees, including the Committee on Toxicity Testing and Assessment of Environmental Agents, the Committee on Improving Risk Analysis Appraoches Used by U.S. EPA, the Committee on Risk Characterization, and the Committee on Comparative Toxicology of Naturally Occurring Carcinogens. She is a member, fellow, and councilor of the Society of Risk Analysis and received the society's Outstanding Risk Practitioner Award in 2008. Dr. Zeise received her PhD from Harvard University.
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Board on Environmental Studies and Toxicology