Toxicology Excellence for Risk Assessment (TERA)

2300 Montana Avenue, Suite 409, Cincinnati OH 45211
Phone: 513-542-7475
Fax: 513-542-7487

Email:
TERA@TERA.org

Toxicology & Risk Assessment Conference (TRAC)

The Complexity of Uncertainty: Dealing with Known Unknowns

April 14 17, 2008

Onsite Registration - 11:30 a.m. - 5:00 p.m.

 

Monday, April 14, 2008      1:00 p.m. 5:00 p.m.     Workshops W-1, W-2, W-3 (break 2:30 - 3:00 p.m.)

 

Workshop Chair:

Zwayer, Bette, C.P.M., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment

 

 

W-1.    Replacing Default Values for Uncertainty Factors

Presenters:

Lipscomb, John C., Ph.D., D.A.B.T., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment

Haber, Lynne T., Ph.D., D.A.B.T., Toxicology Excellence for Risk 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

 

The World Health Organization, through the International Programme on Chemical Safety (IPCS), has established guidance on the use of mechanistic data to replace default uncertainty factors for interspecies extrapolation and intraspecies variability in deriving risk values such as Reference Doses (RfDs) and Tolerable Concentrations (TCs).  This guidance informs the choice and application of data that can be used to replace defaults with chemical specific adjustment factors (CSAFs), resulting in values that better reflect the data for the chemical of interest.  CSAFs fall on the continuum of the use of data in deriving risk values.  At one end of the continuum is the use of the traditional defaults, while at the other end is the use of extensive chemical-specific data in physiologically-based pharmacokinetic (PBPK) modeling, or even biologically-based dose-response (BBDR) modeling.  In between these two extremes is the use of categorical defaults (e.g., the dosimetric approach used in the U.S. EPA’s RfC and cancer risk assessment methods) and CSAFs.  The CSAF framework is based on early work by Renwick and applied by IPCS.  This approach first subdivides the uncertainty factors for interspecies differences (UFA) and human variability (UFH) into toxicokinetic (TK) and toxicodynamic (TD) components.  The data relevant for each subcomponent is then evaluated to determine whether chemical-specific data can be used in place of the default.  Any one or all of these four subfactors can be replaced by chemical-specific data.  Use of the CSAF framework allows the improved use of available data in deriving risk values, and can assist in targeting new studies to address uncertainties and lead to more accurate risk values.  CSAFs have been used by the U.S. EPA in deriving an RfD for boron and by Health Canada in deriving a TC for 2-butoxyethanol.  This half-day workshop will provide a brief review of the use of uncertainty factors and historical perspective on the reliance on quantitative data to develop values for inter- and intraspecies extrapolation.  The course will focus on the IPCS methodology for CSAF development, including the thinking process and steps used for evaluating data.  Examples and classroom activities will be used as instructional aids.  Participants are asked to bring a calculator.

 

  

W-2.    Intermediate Topics in Health Risk Assessment of Chemical Mixtures

Presenters:

Teuschler, Linda K., M.S., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment

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

Hertzberg, Richard C., Ph.D., Emory University

 

This half-day workshop presents intermediate topics and hands-on exercises on  methodologies for assessing cumulative health risk from exposure to chemical mixtures, emphasizing issues such as additivity methods, internal dose metrics, physiologically-based pharmacokinetic modeling, toxicological interactions and multiple route exposures.  A brief overview will be given on basic concepts and terminology, with the bulk of the course focused on advanced chemical mixture health risk assessment methods with exercises for several important classes of chemical mixtures (e.g., pesticides, metals, drinking water disinfection by-products).  Workshop topics include: the development of Relative Potency Factors based on internal dose metrics; mechanistic information and interpretation of toxicological interactions; PBPK modeling of changes in kinetics for a binary mixture; and chemical mixtures risk assessment using multiple route exposures.  Discussions include real world examples, exercise results, and general questions and comments.

 

This course targets people familiar with chemical mixtures risk assessment who are interested in stretching beyond simple concepts.  For example, interested individuals might include those who have conducted Superfund/RCRA site assessments, worked on Food Quality Protection Act (1996) issues regarding cumulative risk, conducted pharmacokinetic modeling, been involved with epidemiological or toxicological studies on chemical mixtures or taken an introductory course in Chemical Mixtures Health Risk Assessment.  Emphasis will be on the presentation of new approaches and hands-on exercises representing the latest thinking in this area.

 

 

 W-3.    Toxicogenomics in Risk Assessment

Presenters:

Hess-Wilson, Janet K., Ph.D., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment

Cohen Hubal, Elaine, Ph.D., U.S. EPA, Office of Research and Development, National Center for Computational Toxicology

Ho, Shuk-mei, Ph.D., University of Cincinnati, College of Medicine

Nebert, Daniel W., M.D., University of Cincinnati, College of Medicine

 

Toxicogenomics is the discipline that aims to study the complex gene-environment interaction of the cell’s genome with a chemical and the associated disease outcome, and is an emerging powerful tool for evaluating the exposure to and effects of environmental stressors.  Toxicogenomics has the potential to (1) improve our understanding of an organisms’ response to environmental stressors, (2) advance the development of predictive biomarkers of effect or susceptibility, and (3) enhance the understanding of the molecular mechanisms of toxicity. Advances in genomics have considerable implications for the field of toxicology and risk assessment practices.  The workshop will present an introduction to the science and methodologies of genomic research that has direct implications for risk assessment.  Presentations will link computational and genomic information to adverse outcomes and demonstrate appropriate usage and interpretation of genomic information for risk and hazard assessment. 

 

 

Monday, April 14, 2008     6:00 p.m. 10:00 p.m.     Dinner with the Sharks at Newport Aquarium

 

Tuesday, April 15, 2008     8:00 a.m. 11:45 a.m.    Morning Session

 

8:00 a.m. 8:15 a.m.                      Opening Remarks

 

Conference Co-Chairs:

Lambert, Jason C., Ph.D., D.A.B.T., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment

Roszell, Laurie E., Ph.D., D.A.B.T., U.S. Army Center for Health Promotion and Preventive Medicine

 

 

8:15 a.m. – 11:45 a.m.     Plenary Session (break 9:45 - 10:15 a.m.)

  

1.         Uncertainty in Toxicology and Risk Assessment: How do you Deal with Moving Targets?

Co-Chairs:

Lambert, Jason C., Ph.D., D.A.B.T., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment

Roszell, Laurie E., Ph.D., D.A.B.T., U.S. Army Center for Health Promotion and Preventive Medicine

 

One of the more challenging aspects of both the qualitative interpretation of toxicity data and translation to quantitative estimates of risk is accounting for the uncertainties inherent in the application to human health assessment.  Ecosystems and human populations are constantly changing; at the same time the chemical, physical and/or biological stressors to which these systems are exposed are in flux.  Exposure and toxicity information pertaining to dose-response and temporal relationships among or between various stressors in exposed populations is limited, leading to uncertainty.  Therefore, in risk assessment, uncertainties may arise from extrapolation within or between species, from high experimental dose to low dose, complex exposure scenarios and/or diverse populations.

 

The goal of this session is to present a broad range of issues and challenges addressing some of these uncertainties.  The keynote address highlights the importance of characterizing uncertainty when assessing risk.  The presentations following the keynote will address biological or statistical uncertainties in assessing risk across the paradigm, i.e., from identification of potential hazards, dose-response and exposure assessment, to the application of those data to human populations.  This will include addressing the difficulties that arise when populations are exposed to a myriad of stressors, some known and others unknown.

 

8:15 a.m.          Hypothesis-Based Weight of Evidence to Separate Qualitative and Quantitative Aspects of Uncertainty in Risk Assessment

Rhomberg, Lorenz R., Ph.D., Principal, Gradient Corporation

 

9:00 a.m.          Application of Computer Simulation to Toxicology and Risk Assessment: Multi-scale Modeling

Yang, Raymond S.H., Ph.D., Fellow A.T.S., Colorado State University, College of Veterinary Medicine and Biomedical Sciences

 

9:35 a.m.          The Military Perspective of Uncertainty

Embry, Ellen, M.S., Office of the Assistant Secretary of Defense, Deputy Assistant Secretary of Defense for Force Health Protection and Readiness

 

10:10 a.m.        Break

 

10:40 a.m.        Risk Regulation in 3-D: How to See Costs and Benefits as they Truly Are

Finkel, Adam M., Sc.D., M.P.P., C.I.H., University of Medicine and Dentistry of New Jersey, School of Public Health

                       

11:15 a.m.        Panel Discussion

 

 

11:45 a.m. – 1:00 p.m.                    Lunch

 

 

Tuesday, April 15, 2008     1:00 p.m. 5:00 p.m.      Sessions 2A, 2B and 2C (break 3:00-3:30 p.m.)

 

 

2A.      Pharmaceutical-Related Issues Across Toxicology Disciplines

Co-Chairs:

Roe, Amy L., Ph.D., D.A.B.T., Procter & Gamble

Hawkins, Belinda S., Ph.D., D.A.B.T., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment

 

The management of pharmaceutical-related issues and exposures can involve very broad and diverse fields of toxicology.  In addition to the obvious issues of safety and efficacy that must be met to serve patient needs, controlling exposures in manufacturing and health care personnel, developing risk assessments for un-planned exposures, and the less intuitive impact of pharmaceuticals in the environment must be considered.  This session will attempt to cover pharmaceuticals as a toxicant class in a series of presentations from various perspectives across industry, academia and regulatory/government.

 

1:00 p.m.          Introduction

Roe, Amy L., Ph.D., D.A.B.T., Procter & Gamble

 

1:15 p.m.          Hazardous Drug Exposures to Health Care Workers

Connor, Thomas, Ph.D., National Institute for Occupational Safety and Health

 

1:40 p.m.          Risk Management of Genotoxic Compounds in the Manufacture of Pharmaceuticals

Bercu, Joel P., M.P.H., Eli Lilly

 

2:05 p.m.          Aquatic Environmental Risk Assessment of Pharmaceutical and Personal Care Product Ingredients

Versteeg, Donald J., Ph.D., Procter & Gamble

 

2:30 p.m.          Potential Exposure to Human Prescription Pharmaceutical Residues from Wastewater

Kostich, Mitchell, Ph.D., U.S. EPA, Office of Research and Development, National Exposure Research Laboratory

 

3:00 p.m.          Break

 

3:30 p.m.          Illicit and Legal Drugs and Biomarkers in Municipal Wastewater Influent: A New Tool for Drug Epidemiology

Field, Jennifer A., Ph.D., Oregon State

 

3:55 p.m.          Field Analysis of Methamphetamine in Clandestine Labs: Direct Reading Methods for the Detection of Surface Contamination

Snawder, John E., Ph.D., D.A.B.T., National Institute for Occupational Safety and Health

 

4:20 p.m.          Panel Discussion

 

 

2B.      Behavioral Toxicology

Co-Chairs:

Hess-Ruth, Amy, U.S. Army Center for Health Promotion and Preventive Medicine

CDR Chapman, Gail D., MBA, Ph.D., U.S. Navy, Naval Health Research Center Detachment, Environmental Health Effects Laboratory

 

Many neurological deficiencies are not detected under routine cage-side observations or neuropathology.  By assessing behavioral functions such as motor activity, startle response, and measurements of learning, behavioral toxicology addresses this data gap and adds to the array of tests available to toxicologists.

 

This session will provide an overview of behavioral toxicology, as well as including case studies highlighting the importance of this growing field.  Subjects of discussion would include behavioral endocrinology, rodent and avian behavioral tests within neurotoxicity, developmental neurotoxicology, as well as current standards of behavioral tests in toxicology.

 

1:00 p.m.          Introduction

CDR Chapman, Gail D., M.B.A., Ph.D., U.S. Navy, Naval Health Research Center Detachment, Environmental Health Effects Laboratory

 

1:10 p.m.          Neurobehavioral Toxicity Testing for Risk Assessment

Moser, Virginia C. (Ginger), Ph.D., D.A.B.T., U.S. EPA, Office of Research and Development, National Health and Environmental Effects Research Laboratory

 

1:40 p.m.          The Startle Response and Toxicology: Methods, Use and Interpretation

Crofton, Kevin M., Ph.D., U.S. EPA, Office of Research and Development, National Health and Environmental Effects Research Laboratory

 

2:25 p.m.          Behavioral Measures for Toxicity Tests in the Japanese Quail

Quinn, Michael, Ph.D., U.S. Army Center for Health Promotion and Preventive Medicine

 

3:00 p.m.          Break

 

3:30 p.m.          Sodium Tungstate Effects on Neurobehavioral, Reproductive and Systemic Organs in Sprague-Dawley Rats

Gunasekar, Palur, Ph.D., U.S. Navy, Naval Health Research Center Detachment/ Environmental Health Effects Laboratory

 

4:00 p.m.          Mn Neurotoxicity: A Behavioral and Neuroimaging Perspective

Guilarte, Tomás R., Ph.D., John Hopkins Bloomberg School of Public Health, Department of Environmental Health Sciences

 

4:30 p.m.          Lead Neurotoxicity: Behavioral Effects and Therapeutic Strategies

McGlothan Dziedzic, Jennifer, M.S., John Hopkins Bloomberg School of Public Health, Department of Environmental Health Sciences

 

 

2C.      EPA’s Four Lab Study Integrating the Toxicity and Chemistry of Complex Disinfection By-Product Mixtures

Co-Chairs:

Speth, Thomas F., Ph.D., P.E., U.S. EPA, Office of Research and Development, National Risk Management Research Laboratory

Rice, Glenn E., M.S., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment

 

Chemical disinfection of drinking water reduces concentrations of potentially pathogenic microorganisms but also forms complex mixtures of disinfection byproducts (DBPs), which may be reproductive and developmental toxicants or carcinogens.  Because of the widespread human exposures to DBP mixtures, the U.S. EPA undertook a comprehensive toxicological evaluation of DBP concentrates.  Dubbed the “Four Lab Study” because planning and execution required the collaboration of four Laboratories in the EPA’s Office of Research and Development, the study examined the toxic potential of the concentrates (~100-fold higher than found in treated waters) using in vitro and in vivo toxicity assays.  This session opens with an overview of the study.  Presentations follow describing the preparation of the concentrates using a newly developed reverse osmosis procedure and the chemical analysis of the concentrates that were produced.  Two in vitro assays are described, assessing the mutagenicity of these concentrates, and the effects on trophoblast cells obtained from full term human placentas.  In the second half of the session, the first three presentations will discuss the developmental, reproductive, neurotoxic, and immunotoxic outcomes in a multigenerational rodent bioassay conducted using the drinking water concentrates.  The final presentation discusses the risk assessment implications of the Four Lab Study for complex mixtures of DBPs.

 

1:00 p.m.          The Integrated Disinfection By-Product Mixtures Project (the 4-Lab Study): An Overview

Simmons, Jane Ellen, Ph.D., U.S. EPA, Office of Research and Development, National Health and Environmental Effects Research Laboratory

 

1:30 p.m.          Concentration and Treatment of Drinking Waters in the Four Lab Study

Pressman, Jonathan, Ph.D., U.S. EPA, Office of Research and Development, National Risk Management Research Laboratory

 

1:55 p.m.          Chemical Analysis of Drinking Water Concentrates in the Four Lab Study

Miltner, Richard J., P.E., U.S. EPA, Office of Research and Development, National Risk Management Research Laboratory

 

2:20 p.m.          Pregnancy Outcome in a Multi-Generational Rat Bioassay of Drinking Water Concentrates in the Four Lab Study

Narotsky, Michael G., Ph.D., U.S. EPA, Office of Research and Development, National Health and Environmental Effects Research Laboratory

 

3:00 p.m.          Break

 

3:30 p.m.          Reproductive Development in a Multi-Generational Rat Bioassay of Drinking Water Concentrates in the Four Lab Study

Hunter, E. Sidney, Ph.D., U.S. EPA, Office of Research and Development, National Health and Environmental Effects Research Laboratory

 

3:55 p.m.          Neurotoxicity and Immunotoxicity Outcomes Following Gestational Exposure to Four Lab Drinking Water Concentrates

Luebke, Robert, Ph.D., U.S. EPA, Office of Research and Development, National Health and Environmental Effects Research Laboratory

 

4:20 p.m.          The Effect of Four-Lab-Study Concentrated Mixtures of Drinking Water Disinfection By-products on Human Term Trophoblast Cell Differentiation

Chen, Jiangang, Ph.D., University of California-Davis

 

4:45 p.m.          Implications of the Four Lab Study Results for Evaluating Risks posed by Disinfection By-products

Teuschler, Linda K., M.S., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment

 

 

Tuesday, April 15, 2008     5:30 p.m. – 7:30 p.m.     Evening Session

  

Poster Session/Reception

Poster Session Co-Chairs:

Mattie, David R., Ph.D., D.A.B.T., Air Force Research Laboratory, Applied Biotechnology Branch

Daunt, Patricia A., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment

 

 

Wednesday, April 16, 2008     8:00 a.m. 11:45 a.m.    Sessions 3A, 3B and 3C (break 9:45 - 10:15 a.m.)

 

3A.      Challenges in Assessing Risks from Low Dose Exposures

Co-Chairs

Keshava, Nagu, Ph.D., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment

Fowler, Bruce A., Ph.D., Fellow A.T.S., Agency for Toxic Substances and Disease Registry, Senior Biomedical Research Service

 

Most experimental data from animal studies are conducted at high doses, shorter time period and to single chemicals.  However, humans are exposed to lower doses, for longer durations and to multiple chemicals.  Therefore, estimation of human health risk due to long-term exposures to very low doses of chemicals in the environment poses a number of biological and statistical challenges.  Biological challenges include lack of positive response at very low doses due to shorter duration of exposure, availability of data in animal studies and not in human studies etc.  One of the statistical problems is to extrapolate the animal dose-response relation from the high dose levels where data are available to low dose, which humans might encounter.  The purpose of this symposium is to illustrate a number of these issues through a discussion of the available information at low doses using specific examples of chemicals.

 

8:00 a.m.          Introduction: Challenges in Assessing Risk from Low-Dose Chemical Exposures – a Brief Overview

Keshava, Nagu, Ph.D., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment

 

8:05 a.m.          Low Dose Extrapolation: New Approaches to Old Problems

Cote, Ila, Ph.D., D.A.B.T., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment

 

8:40 a.m.          The Use of Mode of Action Information to Inform Low Dose Estimates of Cancer Risk: A Case Study Involving Carbon Tetrachloride

Eastmond, David A., Ph.D., University of California, Environmental Toxicology and Department of Cell Biology

 

9:10 a.m.          The Intersection of Functional Genomics and Risk Assessment

Ramos, Kenneth S., Ph.D., University of Louisville, Department of Biochemistry and Molecular Biology

 

9:45 a.m.          Break

 

10:15 a.m.        Roles of Heme Biosynthetic Biomarkers in Evaluating Lead, Cadmium, Arsenic Mixture Exposures at LOEL Dose Levels

Fowler, Bruce A., Ph.D., Fellow A.T.S., Agency for Toxic Substances and Disease Registry, Senior Biomedical Research Service

 

10:45 a.m.        Mode of Action and Mixtures Risk Assessment: Paying Attention to Details

Lambert, Jason, Ph.D., D.A.B.T., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment

 

11:15 a.m.        Panel Discussion – Mode of Action and Low Dose Extrapolation: Research Needs to Improve Risk Assessment

 

 

3B.      Updates on Reproductive/Developmental Toxicology and Risk Assessment

Co-Chairs:

Makris, Susan L., M.S., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment

Hooth, Michelle J., Ph.D., D.A.B.T., National Institute of Environmental Health Sciences, National Toxicology Program, Toxicology Branch

 

EPA scientists have many years of practical experience in the application of guidelines in the areas of reproductive and developmental toxicology to hazard characterization and human health risk assessment.  Nevertheless, as with any other scientific discipline, advances in the sciences and in the approaches to screening and testing have yielded a wealth of new considerations and information that have the potential to further influence and/or refine the use of these data in risk assessment.  This session will provide an informative review of recent activities and information in several relevant topic areas.

 

8:00 a.m.          Introduction

Makris, Susan L., M.S., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment

 

8:05 a.m.          Developmental Neurotoxicity Testing: Past, Present and Future

Crofton, Kevin M., Ph.D., U.S. EPA, Office of Research and Development, National Health and Environmental Effects Research Laboratory

 

8:55 a.m.          Developmental Immunotoxicity

Luebke, Robert W., Ph.D., U.S. EPA, Office of Research and Development, National Health and Environmental Effects Research Laboratory

 

9:45 a.m.          Break

 

10:15 a.m.        An Update on the Progress of the Extended One-Generation Reproductive Protocol

Cooper, Ralph L., Ph.D., U.S. EPA, Office of Research and Development, National Health and Environmental Effects Research Laboratory

 

10:45 a.m.        Update on the Mammalian Tier 1 Endocrine Disruptor Screening Protocols

Stoker, Tammy E., Ph.D., U.S. EPA, Office of Research and Development, National Health and Environmental Effects Research Laboratory

 

11:15 a.m.        An Introduction to: “Terminology of Developmental Abnormalities, Version 2”

Solomon, Howard M., Ph.D., GlaxoSmithKline Pharmaceuticals

 

 

3C.      Identification, Ecology, and Risk Assessment of Emerging Cyanobacterial and Harmful Algal Toxins

Co-Chairs:

Zimba, Paul V., Ph.D., U.S. Department of Agriculture, Agricultural Research Service

de la Cruz, Armah, Ph.D., U.S. EPA, Office of Research and Development, National Exposure Research Laboratory

 

Up to 48% of lakes in North America are eutrophic and greater reliance on surface water sources is expected as groundwater can not supply drinking water needs.  Eutrophic water conditions can stimulate algae to grow in dense (bloom) concentrations.  Most blooms have high concentrations of cyanobacteria (blue-green algae) or eukaryotic algae that can produce a wide array of bioactive toxic compounds responsible for human health problems and animal disease and death.  Algal toxins are often grouped by their functional activities based on their toxicological targets: neurotoxins, cytotoxins, dermatotoxins and hepatotoxins.  Additionally, haptophytes such as Prymnesium parvum as well as euglenoid algae (Euglena sanguinea) are also known to cause fish kills.  This session will provide current information on freshwater cyanobacteria, haptophyte, and euglenoid toxins and a risk assessment to animals and humans.

 

8:00 a.m.          Overview of Session and Recent Evidence for Cylindrospermopsis Occurrence in U.S. Potable Water Sources

Zimba, Paul V., Ph.D., U.S. Department of Agriculture, Agricultural Research Service

 

8:15 a.m.          An Overview of Freshwater Toxins

Burkholder, JoAnn M., Ph.D., North Carolina State University

 

8:45 a.m.          Isolation of Novel Toxins: Case Studies

Moeller, Peter, Ph.D., National Oceanic and Atmospheric Administration

 

9:15 a.m.          Harmful Algal Blooms in Multi-Use Reservoirs

Walker, David B., Ph.D., University of Arizona

 

9:45 a.m.          Break

 

10:15 a.m.        Toxic Cyanobacteria in the Laurentian Great Lakes – An Overview of the Past and a Looking Glass to the Future

Wilhelm, Steven W., Ph.D., The University of Tennessee

 

10:45 a.m.        Cyanobacterial Toxins: Toxicity and Human Health Risk

Hawkins, Belinda S., Ph.D., D.A.B.T., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment

 

11:20 a.m.        Panel Discussion and Questions

 

 

11:45 a.m. – 1:00 p.m.                    Lunch

 

 

Wednesday, April 16, 2008      1:00 p.m. 5:00 p.m.     Sessions 4A, 4B and 4C (break 3:00 - 3:30 p.m.)

 

4A.      Uncertainty in Epidemiologic Evaluations of Environmental and Occupational Exposures

Co-Chairs:

Bateson, Thomas, Sc.D., M.P.H., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment

Wright, J. Michael, Sc.D., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment

Park, Robert M., M.S., National Institute for Occupational Safety and Health, Education and Information Division

 

Uncertainty in epidemiologic studies arises under two circumstances: (1) when the results of an epidemiologic study may be biased, or (2) when internally valid results derived from one study population are not validly applied to another study population.  The presence or methodologically justifiable suspicion of bias in an epidemiologic study increases uncertainty in the study results.  Bias-related uncertainty can be related to information bias, confounding, and selection bias.  Separate from the issues of bias-related uncertainty, uncertainty also arises when internally valid results derived from one study population are not applicable to another study population.  This may be characterized as susceptibility or effect modification, for example, when data suggest differential effects by life stage or genetic predisposition.

 

In this session, a series of presentations will highlight challenges related to uncertainty in epidemiologic evaluations of environmental and occupational exposures and showcase methodologies to characterize and potentially minimize those uncertainties.

 

1:00 p.m.          Sources of Uncertainty in Environmental Epidemiological Data

Wright, J. Michael, Sc.D., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment

 

1:15 p.m.          Sources of Uncertainty in Occupational Epidemiological Data

Park, Robert M., M.S., National Institute for Occupational Safety and Health, Education and Information Division

 

1:30 p.m.          Quantitative Analysis of Nonrandom Error in Epidemiologic Studies

Jurek, Anne M., Ph.D., University of Minnesota, Department of Pediatrics, Division of Epidemiology and Clinical Research

 

2:15 p.m.          Sensitivity Analysis and Meta-analysis of Published Epidemiologic Studies in Quantitative Risk Assessment: Methods and Challenges

Van Wijngaarden, Edwin, Ph.D., University of Rochester Medical Center, Department of Environmental Medicine

 

3:00 p.m.          Break

 

3:30 p.m.          The Role of Chrysotile Asbestos Fiber Demension on the Risk of Respiratory Disease in South Carolina Textile Workers

Gilbert, Steven J., M.S., National Institute for Occupational Safety and Health, Education and Information Division

 

4:00 p.m.          Correction for Classical Measurement Error in Drinking Water Disinfection By-products Studies Using Multiple Surrogate Exposures

Bateson, Thomas, Sc.D., M.P.H., U.S. EPA, Office of Research and Development, National Center for Environmental Assessment

 

4:30 p.m.          Panel Discussion

 

 

4B.      Toxicology and Risk Assessment of Jet Fuel and Alternative Fuels