NORA Exposure Assessment Methods Team Whitepaper

1. NORA Exposure Assessment Methods Team Whitepaper Research Needs and Priorities Beth Donovan Reh National Institute for Occupational Safety and Health (NIOSH) 4676 Columbia Parkway, R-11 Cincinnati, Ohio 45226 (513) 841-4374

2. NORA • The National Occupational Research Agenda • unveiled in April 1996 • developed by NIOSH and approximately 500 of its partners in the public and private sectors

3. NORA • Focus on the formation of partnerships to assist in the development, pursuit, review, and dissemination of research for each NORA priority research area

4. NORA Priority Research Areas • 21 priority areas • 20 teams (two areas combined into one team -- musculoskeletal disorders)

5. NORA Teams

6. NIOSH Labor Government NORA TEAM Academia Associations Private Industry

7. EAM Team Composition • NIOSH • Exxon Biomedical Sciences, Inc. • Naval Medical R&D Command/ DOD • DOE • University of North Carolina • Occidental Chemical Company • George Washington University • United Mine Workers • ACGIH

8. Chemistry Biology/toxicology Industrial hygiene Nursing Epidemiology Physics Physiology Electrical engineering Industrial Hygiene Monitoring methods development Biomonitoring Teaching Instrumentation Energy-related health Physical & chemical characterization in relation to toxicology NIOSH Team Members External Partners

9. Initial EAM Team Goals • Define boundaries of EAM • Define EA and related terms • Identify EAM priority research areas • Support and co-sponsor related symposia • Applied Workshop on Occupational and Environmental Exposure Assessment (1998) • Role of Human Exposure Assessment in the Prevention of Environmental Disease (1999) • Int’l Symposium on Occupational Exposure Databases (1999) • Propose research grant topics

10. Purpose • To identify and promote major areas of EAM research, which, if completed, would have substantial impact on the protection of worker health.

11. EAM Research Needs and Priorities • Background • Purpose • Definitions • Research Priorities

12. Occupational Exposure • The act or condition of being subjected (as a result of work) to a chemical, physical, or biological agent, or to a specific process, practice, behavior, or work organization.

13. Occupational Exposure Assessment • The application of a body of knowledge to determine the relevant characteristics of one or more factors in an environment which pose health and safety risks to workers. • The process includes identifying and characterizing workplace exposures, evaluating their significance, and developing estimates of exposure for individuals or groups of workers which may be used in risk assessment or exposure-response studies. • The assessment is based on measurement and evaluation of one or more characteristics of the exposure environment, and may or may not involve hypothesis testing.

14. Hazard identification: establishing the existence of a hazard through field observations or laboratory analysis of the exposures or adverse health effects. • Exposure Characterization: describing the qualities of a given environment -- which may include, magnitude, frequency, and duration of exposure; chemical and physical properties of an agent; organizational or behavioral properties of an environment; and the potential for interaction with the human body or influence over human behavior.

15. Exposure Evaluation: determining the significance of an exposure relative to known or perceived risks. • Exposure Estimation: developing an approximate exposure value for an individual or a statistical distribution of exposure values for groups of workers in similar exposure conditions.

16. Research Priorities • Study Design • Monitoring Methods • Toxicology • Education and Communication

17. Study Design • Data quality • Data collection • Data management • Data analysis • Other

18. Data Quality • Develop a practical exposure assessment guide linked with matching software for managing and maintaining exposure assessment data.

19. Data Collection • Perform research to help improve, validate, and standardize exposure matrix variables and data collection techniques. • Define and document new exposure matrices for public access. • Develop innovative mechanisms for continually updating the NOES dataset.

20. Data Management • Create a National Occupational Exposure Database (NOEDB).

21. Data Analysis • Develop an exposure data interpretation and analysis guide. • Degree of statistical rigor necessary for the variety of circumstances that confront practicing industrial hygienists. • Design of performance oriented exposure assessment strategies.

22. Other Study Design Items • 10 other study design items were deemed important and suitable for research support • Listed in white paper, but no formal team recommendations.

23. Monitoring Method Development • Method Guidelines • Biomonitoring Methods • Dermal Exposure Measurement Methods • New Environmental Monitoring Methods

24. Method Guidelines • Produce guidance documents for the development and evaluation of monitoring methods • direct reading instruments, data loggers, or diffusive samplers • dermal exposure monitoring • biological monitoring.

25. Biomonitoring Methods • Develop methods to assess the internal and biologically effective doses. • Characterize biomarker performance (specificity, sensitivity, accuracy, etc.) • Develop new, validated biomarkers to link exposure to disease .

26. Biomonitoring Methods (cont.) • Perform more research on host susceptibility and risk of disease. • Publish biomonitoring methods as a companion to, or part of, the NMAM. • Perform research and engender dialogue to help resolve the ethical, legal, and social issues of biomonitoring.

27. Dermal Exposure Measurement • Substantially increase research on dermal absorption and dermal exposure assessment methods.

28. New Methods • Develop and evaluate new or improved chemical methods -- especially ones that are field-deployable, measure low concentrations, or measure multiple analytes.

29. New Methods (cont.) • Develop and evaluate new or improved methods for assessing exposures to microbial contamination.

30. New Methods (cont.) • Develop and evaluate new or improved methods for assessing exposures to physical hazards.

31. Toxicology • Perform more research to ascertain the mechanism of action of chemical, physical, and biologic agents. • Develop a toxicity assessment protocol, including guidelines for systemic approach to estimating occupational exposure limits.

32. Toxicology (cont.) • Develop and evaluate pharmacokinetic and predictive models of toxicity. • Perform more research to develop a general toxicology approach to assess exposure to mixtures.

33. Education • Determine the specific knowledge elements needed for exposure assessment and whether they are taught in curricula. • Determine if a unified set of educational requirements or guidelines can be established and make recommendations to appropriate accrediting bodies.

34. Communication • Identify and develop effective methods for communication of exposure assessment elements, results, and conclusions . • Consideration of various audiences is necessary, as certain methods of communication may be more effective for public health professionals, others for workers, and yet others for policy makers.

35. Study Design Monitoring Methods EXPOSURE ASSESSMENT METHODS Education & Communication Toxicology

36. Roundtable Questions • Dermal exposure and aggregate exposure • Cumulative exposure as an IH priority • Substances without OELs • IH answers to workers and managers • IH reports • Codifying IH practice • Individual and organizational roles for spawning new IH practices