2009 Toxicology and Risk Assessment Conference

2009 Toxicology and Risk Assessment Conference Toxicology and Risk Assessment from the Trenches April 27-30, 2009 Conference Co-chairs: Rieth, Susan H., M.P.H., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment CDR Chapman, Gail D., Ph.D., M.B.M., U.S. Navy, Naval Health Research Center Detachment, Environmental Health Effects Laboratory Monday, April 27, 2009 Workshops 12:30 p.m. – 4:30 p.m. Workshop Chair: Zwayer, Bette, C.P.M., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment 11:30 a.m. – 4:30 p.m. 12:30 p.m. – 4:30 p.m. 2:15 p.m. – 2:45 p.m. Registration Workshops W-1, W-2 and W-3 Break W-1. Teaching Computational Methods to Federal Agency Staff Presenters: Slikker, William, Jr., Ph.D., Food and Drug Administration, National Center for Toxicological Research This teaching workshop is intended to introduce computational approaches to Federal Agency Staff who are interested in learning more about how these methods may help them improve job performance with regard to in silico methods for chemical screening, conducting risk assessments for chemical mixtures, physiologically based - pharmacokinetic modeling (PBPK), and quantitative structure activity relationships (QSAR). The focus of this workshop will be on how computational toxicology methods may be applied to dealing with common but complex risk assessment issues which confront toxicologists across the Federal agencies on a daily basis. It is hoped that this workshop introduction to these methods will provide current non-practitioners with an increased understanding of how modern computational methods may help them provide better and more expeditious answers to common risk assessment questions. Speakers: Tong, Weida, Ph.D., Food and Drug Administration, National Center for Toxicological Research, Director, Center for Toxicoinformatics Mumtaz, Moiz M., Ph.D., Agency for Toxic Substances and Disease Registry, Senior Biomedical Research Service Wilson, Jewell D., Ph.D., Agency for Toxic Substances and Disease Registry, Division of Toxicology and Environmental Medicine McPhail, Brooks, Ph.D., Oak Ridge Institute for Science and Education, Agency for Toxic Substances and Disease Registry W-2. Emergency Risk Communication Presenter: Reynolds, Barbara J., Ph.D., Center for Disease Control and Prevention, Office of the Director Organizations must have the public's trust to do their mission. The CDC Crisis and Emergency Risk Communication (CERC) course is a fast-paced, interactive course that gives participants essential knowledge and tools to navigate the harsh realities of communicating to the public, media, partners, and stakeholders during an intense event. The CERC course provides practical information, exercises, and tools to build and execute a confident communication response. W-3. Crash Course in Risk Assessment Presenters: Reid, Jon, Ph.D., D.A.B.T., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment Lipscomb, John C., Ph.D., D.A.B.T., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment Lambert, Jason C., Ph.D., D.A.B.T., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment Rice, Glenn E., M.S., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment This half-day course focuses on risk assessment for orally encountered chemicals. Chemical risk assessment is a complex and ever-evolving process. There are fundamental guiding principles and default methodologies that should be understood by those considering further activities in the area of risk assessment. The principles have been organized by the National Research Council in the Risk Assessment Paradigm. Several activities comprise the paradigm: Hazard identification, Exposure Assessment, Dose-Response Evaluation and Risk Characterization. This course is organized around these activities; examples from the literature will be used to communicate key concepts and calculations. This course will instruct the application of basic methodologies used by the U.S. EPA in estimating the cancer and noncancer risks for orally encountered substances. Classroom exercises may be used as instructional aides—participants should bring a calculator. A CD containing key U.S. EPA risk assessment guidance documents will be provided to students. Class limited to 20 participants. 5:00 p.m. – 10:00 p.m. Social Event Take Me Out to the Ballgame… Cincinnati Reds vs. Houston Astros Tuesday, April 28, 2009 Morning Session 8:00 a.m. – 8:15 a.m. Opening Remarks 8:00 a.m. – 11:45 a.m. Conference Co-chairs: Rieth, Susan H., M.P.H., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment CDR Chapman, Gail D., Ph.D., M.B.M., U.S. Navy, Naval Health Research Center Detachment, Environmental Health Effects Laboratory 8:15 a.m. – 11:45 a.m. 10:00 a.m. – 10:30 a.m. 1. Plenary Session Break Toxicology and Risk Assessment from the Trenches Co-chairs: Rieth, Susan H., M.P.H., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment CDR Chapman, Gail D., Ph.D., M.B.M., U.S. Navy, Naval Health Research Center Detachment, Environmental Health Effects Laboratory The goal of this plenary session is to provide insights into risk-based decision making from public health professionals operating in the “risk assessment trenches.” The trenches can be a messy place! It is important for all the stakeholders contributing to risk management decisions to understand each other and communicate at all levels. The plenary speakers will provide perspectives from their varied experiences in the risk assessment trenches. Human health and ecological viability are challenged by a wide range of environmental stressors. Toxicologists develop the backbone experimental knowledge-base used to identify human health and environmental hazards associated with exposure to these environmental stressors. It is the role of the risk assessor to evaluate the available hazard information in the context of a specific exposure scenario and characterize potential human health and environmental risks using the National Academy of Science’s risk assessment paradigm. It is often the role of the risk manager to manage these risks “from the trenches.” The risk manager may involve a wide variety of individuals or groups, such as first responders, clinicians, industrial hygienists, and government regulatory bodies. Decisions on whether, to what extent, and how to mitigate risks are never made in a vacuum. Decisions can be influenced by a range of factors, such as the urgency to take remedial actions, the cost and feasibility of remediation, competing resources, public perception of risk, stakeholder interests, or pressure from Congress. Inevitably, the risk manager must deal with making decisions in the face of uncertainty. One key to successfully operating in the “risk assessment trenches” is the effective communication of risk—an area where the professional risk communicator can play an invaluable role. The view from the “trenches” provided in this plenary is intended to facilitate a better understanding of the different perspectives of risk assessment and risk management. The ultimate goal is well informed risk management decisions and effective risk communication. 8:15 a.m. Future Directions in Risk Assessment Peter W. Preuss, Ph.D., Center Director, National Center for Environmental Assessment, Office of Research and Development, U.S. Environmental Protection Agency 8:45 a.m. Keynote Address [to be announced] Toxicology and Risk Assessment during an Emergency Chemical Release: Bridging the Roles of Incident Command, Hazmat Response, and Public Health Protection Gandy, Jay, Ph.D., CTEH & University of Arkansas for Medical Sciences, Department of Environmental & Occupational Health Break Title [to be provided] Burke, Thomas A., Ph.D., M.P.H., John Hopkins Bloomberg School of Public Health, Department of Health Policy and Management Quick, Caring, Complete: The Principles of Successful Crisis and Emergency Risk Communication Reynolds, Barbara J., Ph.D., Center for Disease Control and Prevention, Office of the Director Panel Discussion 9:30 a.m. 10:00 a.m. 10:30 a.m. 11:00 a.m. 11:30 a.m. 11:45 a.m. – 1:00 p.m. Tuesday, April 28, 2009 Lunch 1:00 p.m. – 5:00 p.m. Afternoon Sessions 1:00 p.m. – 5:00 p.m. 3:00 p.m. – 3:30 p.m. 2A. Sessions 2A, 2B and 2C Break Nanotoxicity: Toxicity and Issues of Exposure for Nanoparticles Co-chairs: CDR Methner, Mark M., Ph.D., C.I.H., National Institute for Occupational Safety and Health, NIOSH Nanotechnology Research Center Mattie, David R., Ph.D., D.A.B.T., Air Force Research Laboratory, 711 Human Performance Wing, Human Effectiveness Directorate This session will present research related to the potential toxicity of various nanoparticles. Emphasis will be on in vitro screening, the skin and environmental effects. In addition, the session will examine issues related to the potential exposure to nanoparticles in occupational settings with a discussion of risk management. There will also be a discussion about how particle counting instruments respond and measure nanoparticles. 1:00 p.m. Progress Toward Understanding Exposure to Engineered Nanoparticles; Support for Risk Characterization Geraci, Charles L., Ph.D., C.I.H., National Institute for Occupational Safety and Health, Nanotechnology Research Center In Vitro Toxicity Assessment of Engineered Nanoparticles Hussain, Saber M., Ph.D., Air Force Research Laboratory, 711 Human Performance Wing, Applied Biotechnology Branch Biological Interactions of Nanomaterials in Skin Monteiro-Riviere, Nancy A., Ph.D., North Carolina State University, Center for Chemical Toxicology Research and Pharmacokinetics, Investigative Dermatology and Toxicology Break What Happens to Nanomaterials in the Environment? Understanding Fate, Stability, and Ecotoxicity Steevens, Jeffery A., Ph.D., U.S. Army Engineer Research and Development Center, Environmental Risk Assessment Team Evaluating the Equivalency of Direct-Reading Nanoparticle Monitor Results Pearce, Terri A., Ph.D., National Institute for Occupational Safety and Health, Division of Respiratory Disease Studies, Laboratory Research Branch Panel Discussion 1:40 p.m. 2:20 p.m. 3:00 p.m. 3:30 p.m. 4:10 p.m. 4:50 p.m. 2B. Applications of Computational Toxicology for Toxicology Testing and Risk Assessments Co-chairs: Slikker, William, Jr., Ph.D., Food and Drug Administration, Director, National Center for Toxicological Research Fowler, Bruce A., Ph.D., Fellow A.T.S., Agency for Toxic Substances and Disease Registry, Senior Biomedical Research Service This session is focused on presentations which highlight results of various research studies which demonstrate how computational toxicology methods have been applied for characterization and prediction of chemical toxicity. Presentations will include studies on molecular docking techniques, dose-reconstruction, quantitative structure activity relationships (QSAR) and bioinformatic methods for interpretation of large data sets. The overall purpose of this session will be to demonstrate how computational toxicology methods have been of great value for improving the quality of chemical risk assessments needed to address a number of commonly encountered exposure situations. 1:00 p.m. Autism Spectrum Disorder: High-Throughput Screening for Potential Candidate Genes and Etiologic Hazardous Agents of Environmental Origin Demchuk, Eugene, Ph.D., Agency for Toxic Substances and Disease Registry Computation Toxicology Methods Applied to Characterization and Prediction of Chemical Toxicity Ruiz, Patricia, Ph.D., Agency for Toxic Substances and Disease Registry, Division of Toxicology and Environmental Medicine vLiver: Simulating Hepatic Tissue Lesions as Virtual Cellular Systems Shah, Imran, Ph.D., U.S. EPA, Office of Research and Development, National Center for Computational Toxicology 1:40 p.m. 2:25 p.m. 3:00 p.m. 3:30 p.m. Break Search for Markers of Drug Induced Liver Injury: The Liver Toxicity Biomarker Study Fuscoe, James C., Ph.D., U.S. Food and Drug Administration, National Center for Toxicological Research The Potential of Genomic Dose-Response Data to Define Mode-of-Action and LowDose Behavior of Chemical Toxicants Thomas, Russel S., Ph.D., The Hamner Institutes for Health Sciences, Division of Computational Biology Case Studies of Application of SAR/QSAR in Human Health Risk Assessment Wang, Nina Ching Y., Ph.D., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment 4:10 p.m. 4:50 p.m. 2C. Approaches to Cancer Assessment in EPA’s Integrated Risk Information System (IRIS) Program Co-chairs: Kadry, Abdel-Razak M., D.V.M., Ph.D., D.A.B.T., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment Hammerstrom, Karen A., J.D., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment The United States Environmental Protection Agency’s Integrated Risk Information System (IRIS) Program develops assessments of health effects that may result from chronic exposure to chemicals in the environment. The IRIS database contains more than 540 assessments, which address the first two steps (hazard identification and dose-response evaluation) of the risk assessment process. Since 2005, when the EPA Guidelines for Carcinogen Risk Assessment were finalized (http://www.epa.gov/cancerguidelines), IRIS cancer assessments have implemented new approaches prescribed in the Guidelines and expanded the use of complex scientific methods to perform quantitative dose-response analysis. The implementation of the Guidelines has presented scientific challenges and opportunities. Two main challenges are (a) the selection of a descriptor for carcinogenic potential and (b) the application of Age-Dependent Adjustment Factors (ADAFs) for carcinogens acting via a mutagenic mode of action (MOA). Other challenges include application of the Guidelines MOA framework to inform selection of quantitative models for cancer dose-response assessment, expansion of the use of physiologically-based pharmacokinetic models, analysis of the combined risk from multiple types of tumors, and methods for using human data in quantitative dose-response analysis. The presentations in this session show the complexity of cancer assessment in the IRIS Program and the challenges faced in assessing the hazards and risks of exposure to environmental chemicals. (This abstract does not necessarily reflect EPA policy. Mention of trade names or commercial products does not constitute endorsement or recommendation for use.) 1:00 p.m. Introduction and Overview Kadry, Abdel-Razak M., D.V.M., Ph.D., D.A.B.T., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment Weight-of-Evidence Descriptors for Cancer Jones, Samantha J., Ph.D., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment Nonlinear MOAs: A Case Study With Ethylene Glycol Monobutyl Ether (EGBE) 1:15 p.m. 1:40 p.m. Gift, Jeffrey S., Ph.D., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment 2:05 p.m. Mutagenic MOA and Application of Age-Dependent Adjustment Factors (ADAFs): A Case Study with 1,2,3-Trichloropropane Gehlhaus, Martin W., III, M.H.S., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment Analysis of Population Variability and Sensitivity Through PhysiologicallyBased Pharmacokinetic (PBPK) Modeling: A Case Study with Dichloromethane Schlosser, Paul, Ph.D., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment Break Cancer Quantitative Issues Hogan, Karen A., M.S., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment Combining Risks from Several Tumor Types Kopylev, Leonid, Ph.D., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment Use of Life-Table Methods for Modeling Human Data Cooper, Glinda S., Ph.D., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment 2:30 p.m. 3:00 p.m. 3:30 p.m. 4:00 p.m. 4:30 p.m. Tuesday, April 28, 2009 Evening Session Poster Session and Reception 5:45 p.m. – 7:45 p.m. Poster Session Co-chairs: Mattie, David R., Ph.D., D.A.B.T., Air Force Research Laboratory, 711 Human Performance Wing, Human Effectiveness Directorate Lambert, Jason C., Ph.D., D.A.B.T., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment Wednesday, April 29, 2009 Morning Session 8:00 a.m. – 11:45 a.m. 9:45 a.m. – 10:15 a.m. Sessions 3A, 3B and 3C Break 8:00 a.m. – 11:45 a.m. 3A. Breast Milk Exposure of Environmental Pollutants Co-chairs: Mukerjee, Debdas, Ph.D., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment Doerge, Daniel R., Ph.D., U.S. Food and Drug Administration, National Center for Toxicological Research Persistent chemical pollutants bioaccumulated by the mother can be transferred to the fetus during pregnancy and to the newborn infant during breast-feeding. Contaminants bioaccumulated by the mother are released to the blood compartment during pregnancy causing mass transfer of the contaminants to the fetus. Residues or metabolites of numerous environmental chemicals currently used as well as those banned for several decades are found in human breast milk samples. In addition, residues of many pharmaceuticals used by women have also been detected in breast milk. Because breast milk is the primary source of nutrition to infants, its composition is of crucial importance. In this session the speakers will discuss prenatal and postnatal exposures to chemicals, both contaminants and endogenous, compare infant's exposure to chemical contaminants of those who were breast fed with those who were formula-fed and possible preventive measures that can reduce the exposure to chemical contaminants. 8:00 a.m. Introductory Remarks Doerge, Daniel R., Ph.D., U.S. Food and Drug Administration, National Center for Toxicological Research Mukerjee, Debdas, Ph.D., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment Perchlorate Exposure and Dose Estimates for Breastfed and Formula-Fed Infants Blount, Benjamin C., Ph.D., Centers for Disease Control and Prevention, Coordinating Center for Environmental Health and Injury Prevention, National Center for Environmental Health Organochlorine Residues in Breast Milk of Inuit Mothers Ayotte, Pierre, Ph.D. Laval University, Canada Break Children’s Exposure to Arsenic through Breast Milk Pathway Bhattacharya, Shelley, Ph.D., Visva Bharati University, Santiniketan, India Bioavailability of Soy Isoflavones through Placental/Lactational Transfer and Soy Food Doerge, Daniel R., Ph.D., U.S. Food and Drug Administration, National Center for Toxicological Research Panel Discussion 8:40 a.m. 9:10 a.m. 9:45 a.m. 10:45 a.m. 11:10 a.m. 11:45 a.m. 3B. Ecotoxicity and Risk Assessment of Military Relevant Materials Co-chairs: Quinn, Michael J., Jr., Ph.D., U.S. Army Center for Health Promotion and Preventive Medicine, Health Effects Research Program Harvey, Lana D., M.S., U.S. Air Force School of Aerospace Medicine, Technical Support Branch Military activities associated with training, munition manufacturing, and demilitarization operations have resulted in contamination of soil, sediment, and surface water at many military installations. The DoD has developed novel predictive toxicity models to be used with current ecological risk assessment practices. This session will summarize current advancements that have been made in the determination of the toxicity of many military-specific environmental toxins and will discuss future directions with an emphasis on needs for more effective ecological risk assessment practices. 8:00 a.m. Introduction Quinn, Michael J., Jr., Ph.D., U.S. Army Center for Health Promotion and Preventive Medicine, Health Effects Research Program Harvey, Lana D., M.S., U.S. Air Force School of Aerospace Medicine, Technical Support Branch Toxicological Responses of Red-Backed Salamanders to Soil Exposures of Individual Explosive Compounds, Metals, and Mixtures Bazar, Matthew, Ph.D., U.S. Army Center for Health Promotion and Preventive Medicine, Toxicity Evaluation Program Western Fence Lizards (Sceloporus occidentalis) as a Model to Investigate the Toxicity of Military Munition Compounds McFarland, Craig A., Ph.D., U.S. Army Center for Health Promotion and Preventive Medicine, Health Effects Research Program A Comparison of Avian Toxicities to Explosive Compounds Quinn, Michael J., Jr., Ph.D., U.S. Army Center for Health Promotion and Preventive Medicine, Health Effects Research Program Break Ecotoxicogenomics: Data-Rich Tools Provide Interesting New Perspectives in Ecotoxicology and Environmental Quality Assessment Gust, Kurt A., Ph.D., U.S. Army Corps of Engineers, Engineer Research and Development Center Ecological Risk Assessment: Recent Advancement and Approaches for Estimating Risks to Wildlife Johnson, Mark S., Ph.D., U.S. Army Center for Health Promotion and Preventive Medicine, Health Effects Research Program 8:10 a.m. 8:40 a.m. 9:10 a.m. 9:45 a.m. 10:15 a.m. 10:45 a.m. 3C. Advances in Exposure and Toxicity Assessment of Particulate Matter Co-chairs: Gunasekar, Palur G., Ph.D., Naval Health Research Center Detachment, Environmental Health Effects Laboratory Stanek, Lindsay W., Ph.D., M.S.P.H., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment Coarse (10 µm) and fine (2.5 μm) particulate matter (PM) comes from a variety of anthropogenic and natural sources, including combustion processes and windblown dust. These particles deposit in various regions of the lungs depending on particle size, breathing conditions, individual-specific respiratory tract anatomy, and deposition mechanisms. Batteries of scientific studies have linked PM alone (especially PM2.5) or in combination with other air pollutants (toxic industrial chemicals and materials, endemic, disease-causing microorganisms, metal fragments, nonmaterial, atmospheric gases, etc.) with respiratory health effects including acute respiratory symptoms, chronic bronchitis, aggravated asthma and decreased lung function. Cardiovascular effects such as ECG abnormalities, altered vasomotor function, systemic inflammation, and hospital admissions for ischemic heart disease and congestive heart failure have also been associated with exposure to PM. Collectively, these health effects may impact human performance, particularly in troops deployed to the Middle East who are potentially exposed to airborne dust or other aerosols. Individuals susceptible to PM health effects include those with preexisting heart or lung disease and the elderly. Currently, several expert bodies have evaluated the scientific literature and recommended improvements in procedures and technologies (i.e., sensor integration): (1) assess current and future approaches to monitor exposures to potential harmful agents, including chemical and biological warfare agents; (2) detect and monitor concentrations of harmful agents; (3) estimate exposure concentrations and patterns of exposure for individuals; and (4) develop computational methods and biological markers for estimating exposure concentration and health outcome. This session will provide an overview of emerging issues in exposure assessment and recent epidemiological or toxicological findings attributable to PM exposure. Emphasis will be on the presentation of new approaches in terms of detecting, monitoring and tracking low levels of PM-containing chemical agents and addressing health risk that arise when populations are exposed to these agents. 8:00 a.m. Introduction Gunasekar, Palur G., Ph.D., Naval Health Research Center Detachment, Environmental Health Effects Laboratory Middle East Dust: Potential Toxicological Effects from Acute and Chronic Exposure CAPT Lyles, Mark B., D.M.D., Ph.D., U.S. Navy, Bureau of Medicine and Surgery, Research Program Integration and Mission Development Health Outcomes Following Exposure to Ultrafine Particulate Matter Elder, Alison C.P., Ph.D., University of Rochester, School of Medicine and Dentistry, Department of Environmental Medicine Epidemiological Insights Into the Clinical Implications of Elevated Particulate Matter Levels in Deployed Settings Weese, Coleen B., M.D., M.P.H., U.S. Army Center for Health Promotion and Preventive, Occupational and Environmental Medicine Program Break Characterization of Aerosols Generated from Ballistic Impacts of Tungsten Heavy Alloys Schuster, Brian E., Ph.D., U.S. Army Research Laboratory, Terminal Effects Division Size and Time-Resolved Composition of Baghdad Aerosols Cahill, Catherine, Ph.D., University of Alaska Fairbanks, Geophysical Institute and Department of Chemistry Effects of Cigarette Smoke and Particulate Matter Derived from Iraqi Desert Sand on Rats LT Wagner, Dean J., Ph.D., U.S. Navy, Naval Health Research Center Detachment, Environmental Health Effects Laboratory Wrap-up Stanek, Lindsay W., Ph.D., M.S.P.H., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment 8:10 a.m. 8:40 a.m. 9:10 a.m. 9:40 p.m. 10:10 a.m. 10:40 a.m. 11:10 a.m. 11:45 a.m. 11:45 a.m. – 1:00 p.m. Lunch Wednesday, April 29, 2009 Afternoon Sessions 1:00 p.m. – 5:00 p.m. 3:00 p.m. – 3:30 p.m. 4A. Sessions 4A, 4B and 4C Break 1:00 p.m. – 5:00 p.m. Clinical Toxicology and Risk Assessment Co-chairs: Petersen, Daniel D., Ph.D., D.A.B.T., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment Snawder, John E., Ph.D., National Institute for Occupational Safety and Health, Biological Monitoring Laboratory Section This session will concentrate scientific basis for the rapid assessment and hospital care of the two million people that are poisoned each year that require acute intervention. Speakers will cover patient evaluations with regards to the various toxic syndromes (sympathomimetic, anticholinergic, cholinergic or narcotic), diagnosis of poisoning with common agents, case examples, treatment options and antidotes. We will also cover intentional poisoning problems in homeland security applications with special emphasis on nervous system poisoning, envenomations by snakes and spiders, and poisoning by plants. 1:00 p.m. Toxindromes Bond, G. Randall, M.D., Cincinnati Children’s Hospital Medical Center Neurologic Poisoning in Homeland Security Snook, Curtis, M.D., U.S. EPA, Office of Solid Waste and Emergency Response Break Venomous Animal Injuries Otten, E. Mel, M.D., University of Cincinnati Medical School Plant Poisoning Petersen, Daniel D., Ph.D., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment, and the University of Cincinnati Panel Discussion 2:00 p.m. 3:00 p.m. 3:30 p.m. 4:10 p.m. 4:50 p.m. 4B. Emerging Contaminants Co-chairs: Murnyak, George, C.I.H., U.S. Army Center for Health Promotion and Preventive Medicine Vandenberg, John J., Ph.D., U.S. EPA, Office of Research and Development, Division Director, National Center for Environmental Assessment-Research Triangle Park The session on Emerging Contaminants will focus on both programmatic and technical aspects associated with emerging contaminants. Emerging Contaminants are chemicals or materials that are characterized by a perceived or real threat to human health or environment, a lack of a published health standards or an evolving standard. A contaminant may also be "emerging" because of the discovery of a new source, a new pathway to humans, or a new detection method or technology. The session will include an overview of Department of Defense’s (DoD) program to identify and evaluate health, safety, and environmental impacts to DoD operations from emerging contaminants. Another presenter will discuss the evolving state of toxicology as it relates to evaluating chemical health risk. Subject matter experts will discuss technical aspects associated with RDX, naphthalene and manganese. 1:00 p.m. Emerging Contaminants—The New Frontier Yaroschak, Paul J., P.E., Deputy Director for Chemical Materials and Risk Management Office of the Deputy Under Secretary of Defense (Installations & Environment) Emerging Issues in Health Risk Assessment Vandenberg, John J., Ph.D., U.S. EPA, Office of Research and Development, Division Director, National Center for Environmental Assessment-Research Triangle Park Recent Advances on Information Useful in the Risk Assessment of RDX Johnson, Mark S., Ph.D., D.A.B.T., U.S. Army Center for Health Promotion and Preventive Medicine, Health Effects Research Program Panel Discussion Break Upregulation of BNIP3 and Mitochondrial Dysfunction in Manganese-Induced Neurotoxicity Prabhakaran, Krishnan, Ph.D., Naval Health Research Center Detachment, Environmental Health Effects Laboratory Naphthalene—The Evolving State of Its Science Hinz, John P., Air Force Research Laboratory, 711 Human Performance Wing, Health Risk Assessment Support Panel Discussion 1:30 p.m. 2:00 p.m. 2:30 p.m. 3:00 p.m. 3:30 p.m. 4:00 p.m. 4:30 p.m. 4C. National and International Developments in Acute Toxicity Co-chairs Hinz, John P., Air Force Research Laboratory, 711 Human Performance Wing, Health Risk Assessment Support Woodall, George M., Jr., Ph.D., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment This session covers several coordinated efforts of international and national organizations in the conduct, interpretation and application of acute toxicity studies, with an emphasis on the inhalation route of exposure. The first half of this session will focus on activities within the Office of Economic Cooperation and Development (OECD), and on analyses performed to support revisions to the acute inhalation test guideline (TG-403) and other related alternative test guidelines (TG-436). Additional discussion will touch upon revisions to the overarching guidance document for acute inhalation studies (GD-39). Also included in the first half of the session is the ongoing project to develop a guidance document for the derivation of Acute RfD and RfC values. The second half of the session will branch out to discuss more specific applications of endpoint- and chemical-specific information in developing risk assessments for acute exposure scenarios, and concludes with a critical review of some of the basic assumptions used in performing assessments of risk from acute exposures. 1:00 p.m. Introduction Hinz, John P., Air Force Research Laboratory, 711 Human Performance Wing, Health Risk Assessment Support 1:10 p.m. Performance Assessment to Compare a C x T Protocol with the Traditional Protocol for LC-50 Determination (OECD TG-403) Allen, Bruce C., M.S., Bruce Allen Consulting, Chapel Hill, NC Performance Assessment of OECD TG-436: A Classification and Labeling Alternative to TG-403 Greiner, Matthias, D.V.M., M.Sc., Dipl. ECVPH, Federal Institute for Risk Assessment (BfR), Berlin, Germany A Brief Introduction to the New OECD Guidance Document for Inhalation Toxicity Studies: GD 39 Whalan, John E., B.S., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment Derivation of Acute Reference Dose (ARfD) for Pesticides Dellarco, Vicki L., Ph.D., U.S. EPA, Office of Pesticide Programs Break The Role of Developmental Toxicity Studies in Acute Exposure Assessments: Occurrence and Analysis of Single-Day vs. Multiple-Day Exposure Regimens Davis, J. Allen, M.S.P.H., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment Applications of Recent U.S. DoD Research on Acute Chemical Warfare Agent Vapor Toxicity Sommerville, Douglas R., P.E., U.S. Army Edgewood Chemical Biological Center, Modeling, Simulation and Analysis Branch Toxicological Equivalence in Acute Exposure Rhomberg, Lorenz R., Ph.D., Principal Gradient Corporation Closing Remarks Woodall, George M., Jr., Ph.D., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment 1:35 p.m. 2:00 p.m. 2:25 p.m. 3:00 p.m. 3:30 p.m. 3:55 p.m. 4:20 p.m. 4:50 p.m. Wednesday, April 29, 2009 5:30 p.m. – 7:30 p.m. Discussion Session—Incorporating Site-Specific Exposure into Risk Assessment Co-chairs: Budinsky, Robert, Ph.D., The Dow Chemical Company Harvey, Lana D., M.S., U.S. Air Force School of Aerospace Medicine, Technical Support Branch A TRAC Roundtable Discussion on the “Pros and Cons of developing Site-Specific Exposure Information for Risk Assessment and Risk Management Decision Making” will examine the value and necessity of acquiring site-specific exposure and toxicity information for supplementing generic risk assessment default assumptions. An important goal of environmental risk assessments is the reduction of uncertainty in order to be both health-protective and economically feasible. In certain instances, the cost and time involved in generating site-specific exposure and toxicity information may not be justified over the use of standard default risk assessment approaches. Other times, uncertainty requires actual site-specific information to adequately inform the risk assessment and risk management process. This roundtable will use case-studies to illustrate this issue. Thursday, April 30, 2009 Workshops 8:00 a.m. – 4:00 p.m. Workshop Chair Zwayer, Bette, C.P.M., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment 8:00 a.m. – 4:00 p.m. 10:00 a.m. – 10:20 a.m. 2:10 p.m. – 2:30 p.m. 1 hour 15 minutes Workshops W-4, W-5, W-6 and W-7 Break Break Lunch Break W-4. Tungsten Risk Assessments: Assessment of Data and Data Gaps Co-chairs: Roszell, Laurie E., Ph.D., D.A.B.T., U.S. Army Center for Health Promotion and Preventive Medicine Stanek, John, Ph.D., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment Tungsten (W) is a naturally occurring metal used in alloy manufacturing, as a component of filaments in light bulbs, in medical devices, and as a component of military alloys. It has received increased attention in recent years following the CDC finding that residents of Fallon, NV had higher than normal levels of W in their serum. This coincided with the finding that after firing, tungsten from tungsten-nylon munitions could solublize, leading to the potential for W to enter the environment. At the time of these events, there was a lack of reliable data on which to base an assessment of health effects following oral or inhalation exposure to tungsten. Recently, several laboratories have initiated projects intended to address the toxicity of tungsten studies. The goal of this workshop is to address the following questions: 1. What is the state of the science for soluble forms of tungsten? 2. What are the data gaps, and how should the research to fill these gaps be prioritized? This one-day workshop will be divided into 2 parts. In the morning, speakers will address the status of current research to support risk assessment efforts for tungsten. These talks will include presentations on the effects of tungsten following oral and inhalation exposures, as well as carcinogenic effects of tungsten alloys following implantations of solid materials. Also addressed will be the pharmacokinetics of sodium tungstate. These presentations will be followed by an afternoon discussion on data gaps, prioritization of research needs, and strategies for insuring that the best science is available for forthcoming risk assessments. Attendees should have a basic understanding of the risk assessment process as well as the types of toxicological data that feed into a risk assessment. Presenters: Status of EPA’s IRIS Assessment for Tungsten and Salts Stanek, John, Ph.D., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment State of the Science for Soluble Tungsten—EHEL Update CDR, Chapman, Gail D., Ph.D., M.B.M., U.S. Navy, Naval Health Research Center Detachment, Environmental Health Effects Laboratory Carcinogenicity of Embedded Tungsten Alloys Kalinich, John F., Ph.D., Armed Forces Radiobiology Research Institute Rat Serum Antibodies Indicate Oxidative Stress and Renal Toxicity, but not Neurotoxicity Following Subchronic Oral Exposure to Sodium Tungstate McCain, Wilfred C., Ph.D., U.S. Army Center for Health Promotion and Preventive Medicine Biological Disposition and Elimination of Sodium Tungstate After Intravenous or Oral Exposure McDonald, Jacob, Ph.D., Lovelace Respiratory Research Institute, Director, Chemistry and Inhalation Exposure Program Summary of Industry Research Initiatives Concerning Tungsten and Tungsten-Containing Materials Schell, John D., Ph.D., ENTRIX, Inc. Discussion Moderator Dourson, Michael L., Ph.D., D.A.B.T., Toxicology Excellence for Risk Assessment W-5. Written Communication in Risk Assessment: Rhetorical Analysis, Style and Discourse Presenters: Broyles, Cristopher D., M.A., IntelliTech Systems, Inc. Hull, Barbara E., Ph.D., Wright State University Suter, Glenn W., II, Ph.D., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment Science communication is a two-part concept. The first part, the science aspect, comes naturally to most researchers. However, in their efforts to stress precision, accuracy, and validity, researchers can overlook basic rhetorical strategies that are essential to the second part—meaningful communication. This Workshop is designed to strengthen attendees’ written communication skills through a series of five sessions: grammar review, audience analysis, figure and table usage, review-article writing, and methods-article writing. This Workshop will employ active learning and discourse. Participants should bring copies of two of their published works. W-6. Introduction to the Benchmark Dose Methods and Hands-on Application of EPA’s Benchmark Dose Software (BMDS), Version 2.0 Presenters: Gift, Jeffrey S., Ph.D., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment Zhao, Q. Jay, M.P.H., Ph.D., D.A.B.T., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment This day-long course is designed to provide participants with an introduction to the use of the EPA’s Benchmark Dose Software, BMDS 2.0, and its application to risk assessment. The course will cover definitions of important terms and will provide an overview of the BMD process, including determination of data adequacy, model fitting, model comparison, selection of a benchmark response level and modeling linear verses nonlinear responses. Attendees will also work on examples from chemical assessments and learn how to take advantage of the new features offered by version 2.0 of BMDS to compare model runs and prepare summary reports for insertion in their assessments. This workshop will cover all the BMD models available in the current version of the EPA’s BMDS software including the recently added dichotomous hill, background dose and continuous exponential models. W-7. Workshop on Cumulative Risk Assessment Concepts and Methods Presenters: Hertzberg, Richard C., Ph.D., Emory University, Department of Environmental and Occupational Health Lambert, Jason C., Ph.D., D.A.B.T., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment Lipscomb, John C., Ph.D., D.A.B.T., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment MacDonell, Margaret M., Ph.D., Argonne National Laboratory Simmons, Jane Ellen, Ph.D., U.S. EPA, Office of Research and Development, National Health and Environmental Effects Research Laboratory Mumtaz, Moiz M., Ph.D., D.A.B.T., Agency for Toxic Substances and Disease Registry Rice, Glenn E., M.S., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment Teuschler, Linda K., M.S., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment Public interest in the health effects of environmental exposures continues to grow as information increases about multiple stressors, especially contaminants in air, water, and soil from a variety of sources. These sources extend beyond the traditional suite that includes industrial releases and pesticide applications (e.g., pharmaceuticals used in modern agriculture, nanomaterials). Ongoing research efforts are characterizing multiple stressors, environmental fate across exposure settings, and effects of concern to various communities. Cumulative risk assessment (CRA) provides the integrating foundation for linking these factors across space and time, to produce an overall risk picture and better inform health protection programs. Existing methods are being adapted and new tools are being developed to assess potential environmental and toxicological interactions from combined exposures. CRA is often approached from a population perspective, to provide a qualitative indication, and where possible quantification, of the combined risks to human health and the environment from exposures to multiple stressors by multiple routes. Population vulnerability factors such as diet, behaviors, genetic traits, economic status, and social characteristics are being recognized as important issues to be considered. This session will highlights concepts, methods, and resources for assessing cumulative health risk, as illustrated by collaborative initiatives extending from federal, tribal, state, and community organizations to the international arena. Included are new ways to integrate information, including grouping chemicals to assess cumulative exposures and toxicological interactions. These include enhanced models to assess pharmacokinetic and pharmacodynamic interactions and toxicokinetic influences on response using target tissue dose; to extrapolate from this common metric across dose, species, and route; and to identify doses and exposure conditions under which interactions might be expected. Also presented are approaches for assessing multiple effects, extending beyond the traditional critical effect to also account for secondary effects, and considering potential impacts on effect levels due to multiple chemical exposures. W-8. Epidemiologic Fundamentals for Risk Assessment Applications— CANCELLED