NORA Exposure Assessment Methods Team Whitepaper

Research Needs and Priorities

Beth Donovan RehNational Institute for Occupational Safety and Health (NIOSH)4676 Columbia Parkway, R-11Cincinnati, Ohio 45226(513) 841-4374

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

NORA Focus 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 21 priority areas

20 teams (two areas combined into one team -- musculoskeletal disorders)

NORA Teams

N O R A FederalL iason C om m ittee

N O R A LiasonC om m ittee

D iseaseand In jury(7 team s)

W ork Environm entand W orkforce

(6 team s)

Exposure Assessm entM ethods (EAM ) Team

R esearch Toolsand Approaches

(7 team s)

N O R APartnership

Team s

N IO SH O fficeof the D irector

Government

Associations

Labor

PrivateIndustry

NIOSH

Academia

NORATEAM

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

NIOSH Team Members 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

External Partners

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

Purpose

To 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

Background Purpose Definitions

Research Priorities

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.

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.

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.

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.

Research Priorities

Study Design

Monitoring Methods

Toxicology

Education and Communication

Study Design

Data quality

Data collection

Data management

Data analysis

Other

Data Quality

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

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.

Data Management

Create a National Occupational Exposure Database (NOEDB).

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.

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.

Method Guidelines

Biomonitoring Methods

Dermal Exposure Measurement

Methods

New Environmental Monitoring Methods

Monitoring Method Development

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.

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 .

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.

Dermal Exposure Measurement Substantially increase research on

dermal absorption and dermal exposure assessment methods.

New Methods

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

New Methods (cont.)

Develop and evaluate new or improved methods for assessing exposures to microbial contamination.

New Methods (cont.)

Develop and evaluate new or improved methods for assessing exposures to physical hazards.

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.

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.

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.

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.

MonitoringMethods

StudyDesign

EXPOSUREASSESSMENT

METHODS

ToxicologyEducation &Communication

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