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 (513)

NORA 6The National Occupational Research Agenda 6unveiled in April developed by NIOSH and approximately 500 of its partners in the public and private sectors

NORA 6Focus on the formation of partnerships to assist in the development, pursuit, review, and dissemination of research for each NORA priority research area

NORA Priority Research Areas 621 priority areas 620 teams (two areas combined into one team -- musculoskeletal disorders)

NORA Teams

Government Associations Labor Private Industry NIOSH Academia NORA TEAM

EAM Team Composition 6NIOSH 6Exxon Biomedical Sciences, Inc. 6Naval Medical R&D Command/ DOD 6DOE 6University of North Carolina 6Occidental Chemical Company 6George Washington University 6United Mine Workers 6ACGIH

NIOSH Team Members 6Chemistry 6Biology/toxicology 6Industrial hygiene 6Nursing 6Epidemiology 6Physics 6Physiology 6Electrical engineering 6Industrial Hygiene 6Monitoring methods development 6Biomonitoring 6Teaching 6Instrumentation 6Energy-related health 6Physical & chemical characterization in relation to toxicology External Partners

Initial EAM Team Goals 6Define boundaries of EAM 6Define EA and related terms 6Identify EAM priority research areas 6Support 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) 6Propose research grant topics

Purpose 6To identify and promote major areas of EAM research, which, if completed, would have substantial impact on the protection of worker health.

EAM Research Needs and Priorities 6Background )Purpose )Definitions 6Research Priorities

Occupational Exposure 6The 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.

Occupational Exposure Assessment 6The 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. 6The 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. 6The assessment is based on measurement and evaluation of one or more characteristics of the exposure environment, and may or may not involve hypothesis testing.

6Hazard identification: establishing the existence of a hazard through field observations or laboratory analysis of the exposures or adverse health effects. 6Exposure 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.

6Exposure Evaluation: determining the significance of an exposure relative to known or perceived risks. 6Exposure Estimation: developing an approximate exposure value for an individual or a statistical distribution of exposure values for groups of workers in similar exposure conditions.

Research Priorities 6Study Design 6Monitoring Methods 6Toxicology 6Education and Communication

Study Design 6Data quality 6Data collection 6Data management 6Data analysis 6Other

Data Quality 6Develop a practical exposure assessment guide linked with matching software for managing and maintaining exposure assessment data.

Data Collection 6Perform research to help improve, validate, and standardize exposure matrix variables and data collection techniques. 6Define and document new exposure matrices for public access. 6Develop innovative mechanisms for continually updating the NOES dataset.

Data Management 3 Create a National Occupational Exposure Database (NOEDB).

Data Analysis 6Develop 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.

Other Study Design Items 610 other study design items were deemed important and suitable for research support 6Listed in white paper, but no formal team recommendations.

6Method Guidelines 6Biomonitoring Methods 6Dermal Exposure Measurement Methods 6New Environmental Monitoring Methods Monitoring Method Development

Method Guidelines 3 Produce guidance documents for the development and evaluation of monitoring methods )direct reading instruments, data loggers, or diffusive samplers )dermal exposure monitoring )biological monitoring.

Biomonitoring Methods 6Develop methods to assess the internal and biologically effective doses. 6Characterize biomarker performance (specificity, sensitivity, accuracy, etc.) 6Develop new, validated biomarkers to link exposure to disease.

Biomonitoring Methods (cont.) 6Perform more research on host susceptibility and risk of disease. 6Publish biomonitoring methods as a companion to, or part of, the NMAM. 6Perform research and engender dialogue to help resolve the ethical, legal, and social issues of biomonitoring.

Dermal Exposure Measurement 6Substantially increase research on dermal absorption and dermal exposure assessment methods.

New Methods 6Develop and evaluate new or improved chemical methods -- especially ones that are field-deployable, measure low concentrations, or measure multiple analytes.

New Methods (cont.) 6Develop and evaluate new or improved methods for assessing exposures to microbial contamination.

New Methods (cont.) 6Develop and evaluate new or improved methods for assessing exposures to physical hazards.

Toxicology 6Perform more research to ascertain the mechanism of action of chemical, physical, and biologic agents. 6Develop a toxicity assessment protocol, including guidelines for systemic approach to estimating occupational exposure limits.

Toxicology (cont.) 6Develop and evaluate pharmacokinetic and predictive models of toxicity. 6Perform more research to develop a general toxicology approach to assess exposure to mixtures.

Education 6Determine the specific knowledge elements needed for exposure assessment and whether they are taught in curricula. 6Determine if a unified set of educational requirements or guidelines can be established and make recommendations to appropriate accrediting bodies.

Communication 6Identify 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.

Monitoring Methods Study Design EXPOSURE ASSESSMENT METHODS Toxicology Education & Communication

Roundtable Questions 6Dermal exposure and aggregate exposure 6Cumulative exposure as an IH priority 6Substances without OELs 6IH answers to workers and managers 6IH reports 6Codifying IH practice 6Individual and organizational roles for spawning new IH practices