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Suggested Citation:"Front Matter." National Research Council. 2006. Human Biomonitoring for Environmental Chemicals. Washington, DC: The National Academies Press. doi: 10.17226/11700.
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HUMAN BIOMONITORING FOR ENVIRONMENTAL CHEMICALS

Committee on Human Biomonitoring for Environmental Toxicants

Board on Environmental Studies and Toxicology

Division on Earth and Life Studies

NATIONAL RESEARCH COUNCIL OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

Washington, DC
www.nap.edu

Suggested Citation:"Front Matter." National Research Council. 2006. Human Biomonitoring for Environmental Chemicals. Washington, DC: The National Academies Press. doi: 10.17226/11700.
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THE NATIONAL ACADEMIES PRESS

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NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance.

This project was supported by Contract No. 68-C-03-081 between the National Academy of Sciences and the U.S. Environmental Protection Agency with the cosponsorship of the Centers for Disease Control and Prevention. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the authors and do not necessarily reflect the views of the organizations or agencies that provided support for this project.

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Suggested Citation:"Front Matter." National Research Council. 2006. Human Biomonitoring for Environmental Chemicals. Washington, DC: The National Academies Press. doi: 10.17226/11700.
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THE NATIONAL ACADEMIES

Advisers to the Nation on Science, Engineering, and Medicine


The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences.


The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Wm. A. Wulf is president of the National Academy of Engineering.


The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine.


The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Wm. A. Wulf are chair and vice chair, respectively, of the National Research Council.

www.national-academies.org

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COMMITTEE ON HUMAN BIOMONITORING FOR ENVIRONMENTAL TOXICANTS

Members

THOMAS BURKE (Chair),

Johns Hopkins Bloomberg School of Public Health, Baltimore, MD

MARK CULLEN,

Yale Occupational and Environmental Medicine Program, New Haven, CT

GEORGE EADON,

New York State Department of Health, Albany, NY

PETER B. FARMER,

University of Leicester, Leicester, United Kingdom

GARY GINSBERG,

Connecticut Department of Public health, Hartford, CT

CAROL J. HENRY,

American Chemistry Council, Arlington, VA

NINA T. HOLLAND,

University of California, Berkeley, Berkeley, CA

GUNNAR JOHANSON,

Karolinska Institutet, Stockholm, Sweden

BRANDEN B. JOHNSON,

New Jersey Department of Environmental Protection, Trenton, NJ

DOROTHY E. PATTON,

International Life Sciences Institute, Washington, DC

GERALD VAN BELLE,

University of Washington, Seattle, WA

CLAUDE VIAU,

University of Montreal, Montreal, Quebec

ROBIN WHYATT,

Columbia University, New York, NY

RAYMOND S.H. YANG,

Colorado State University, Fort Collins, CO

Staff

EILEEN N. ABT, Project Director

JENNIFER SAUNDERS, Associate Program Officer

NORMAN GROSSBLATT, Senior Editor

RUTH CROSSGROVE, Senior Editor

MIRSADA KARALIC-LONCAREVIC, Research Associate

LUCY FUSCO, Program Associate

MORGAN MOTTO, Senior Project Assistant

RADIAH A. ROSE, Senior Project Assistant

TAMARA DAWSON, Senior Project Assistant

KEMI YAI, Project Assistant

SAMMY BARDLEY, Librarian

Sponsors

U.S. Environmental Protection Agency

Centers for Disease Control and Prevention

Suggested Citation:"Front Matter." National Research Council. 2006. Human Biomonitoring for Environmental Chemicals. Washington, DC: The National Academies Press. doi: 10.17226/11700.
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BOARD ON ENVIRONMENTAL STUDIES AND TOXICOLOGY1

Members

JONATHAN M. SAMET (Chair),

Johns Hopkins University, Baltimore, MD

RAMÓN ALVAREZ,

Environmental Defense, Austin, TX

JOHN M. BALBUS,

Environmental Defense, Washington, DC

THOMAS BURKE,

Johns Hopkins University, Baltimore, MD

DALLAS BURTRAW,

Resources for the Future, Washington, DC

JAMES S. BUS,

Dow Chemical Company, Midland, MI

COSTEL D. DENSON,

University of Delaware, Newark

E. DONALD ELLIOTT,

Willkie Farr & Gallagher LLP, Washington, DC

J. PAUL GILMAN,

Oak Ridge National Laboratory, Oak Ridge, TN

SHERRI W. GOODMAN,

Center for Naval Analyses, Alexandria, VA

JUDITH A. GRAHAM,

American Chemistry Council, Arlington, VA

DANIEL S. GREENBAUM,

Health Effects Institute, Cambridge, MA

WILLIAM P. HORN,

Birch, Horton, Bittner and Cherot, Washington, DC

ROBERT HUGGETT,

Michigan State University (emeritus), East Lansing

JAMES H. JOHNSON JR.,

Howard University, Washington, DC

JUDITH L. MEYER,

University of Georgia, Athens

PATRICK Y. O’BRIEN,

ChevronTexaco Energy Technology Company, Richmond, CA

DOROTHY E. PATTON,

International Life Sciences Institute, Washington, DC

STEWARD T.A. PICKETT,

Institute of Ecosystem Studies, Millbrook, NY

DANNY D. REIBLE,

University of Texas, Austin

JOSEPH V. RODRICKS,

ENVIRON International Corporation, Arlington, VA

ARMISTEAD G. RUSSELL,

Georgia Institute of Technology, Atlanta

ROBERT F. SAWYER,

University of California, Berkeley

LISA SPEER,

Natural Resources Defense Council, New York, NY

KIMBERLY M. THOMPSON,

Massachusetts Institute of Technology, Cambridge

MONICA G. TURNER,

University of Wisconsin, Madison

MARK J. UTELL,

University of Rochester Medical Center, Rochester, NY

CHRIS G. WHIPPLE,

ENVIRON International Corporation, Emeryville, CA

LAUREN ZEISE,

California Environmental Protection Agency, Oakland

Senior Staff

JAMES J. REISA, Director

DAVID J. POLICANSKY, Scholar

RAYMOND A. WASSEL, Senior Program Officer for Environmental Sciences and Engineering

1

This study was planned, overseen, and supported by the Board on Environmental Studies and Toxicology.

Suggested Citation:"Front Matter." National Research Council. 2006. Human Biomonitoring for Environmental Chemicals. Washington, DC: The National Academies Press. doi: 10.17226/11700.
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KULBIR BAKSHI, Senior Program Officer for Toxicology

EILEEN N. ABT, Senior Program Officer for Risk Analysis

KARL E. GUSTAVSON, Senior Program Officer

K. JOHN HOLMES, Senior Program Officer

ELLEN K. MANTUS, Senior Program Officer

SUSAN N.J. MARTEL, Senior Program Officer

SUZANNE VAN DRUNICK, Senior Program Officer

RUTH E. CROSSGROVE, Senior Editor

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OTHER REPORTS OF THE BOARD ON ENVIRONMENTAL STUDIES AND TOXICOLOGY

Assessing the Human Health Risks of Trichloroethylene: Key Scientific Issues (2006)

New Source Review for Stationary Sources of Air Pollution (2006)

Health Risks from Dioxin and Related Compounds: Evaluation of the EPA Reassessment (2006)

Fluoride in Drinking Water: A Scientific Review of EPA’s Standards (2006)

State and Federal Standards for Mobile-Source Emissions (2006)

Superfund and Mining Megasites—Lessons from the Coeur d’Alene River Basin (2005)

Health Implications of Perchlorate Ingestion (2005)

Air Quality Management in the United States (2004)

Endangered and Threatened Species of the Platte River (2004)

Atlantic Salmon in Maine (2004)

Endangered and Threatened Fishes in the Klamath River Basin (2004)

Cumulative Environmental Effects of Alaska North Slope Oil and Gas Development (2003)

Estimating the Public Health Benefits of Proposed Air Pollution Regulations (2002)

Biosolids Applied to Land: Advancing Standards and Practices (2002)

The Airliner Cabin Environment and Health of Passengers and Crew (2002)

Arsenic in Drinking Water: 2001 Update (2001)

Evaluating Vehicle Emissions Inspection and Maintenance Programs (2001)

Compensating for Wetland Losses Under the Clean Water Act (2001)

A Risk-Management Strategy for PCB-Contaminated Sediments (2001)

Acute Exposure Guideline Levels for Selected Airborne Chemicals (4 volumes, 2000-2004)

Toxicological Effects of Methylmercury (2000)

Strengthening Science at the U.S. Environmental Protection Agency (2000)

Scientific Frontiers in Developmental Toxicology and Risk Assessment (2000)

Ecological Indicators for the Nation (2000)

Waste Incineration and Public Health (1999)

Hormonally Active Agents in the Environment (1999)

Research Priorities for Airborne Particulate Matter (4 volumes, 1998-2004)

The National Research Council’s Committee on Toxicology: The First 50 Years (1997)

Carcinogens and Anticarcinogens in the Human Diet (1996)

Suggested Citation:"Front Matter." National Research Council. 2006. Human Biomonitoring for Environmental Chemicals. Washington, DC: The National Academies Press. doi: 10.17226/11700.
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Upstream: Salmon and Society in the Pacific Northwest (1996)

Science and the Endangered Species Act (1995)

Wetlands: Characteristics and Boundaries (1995)

Biologic Markers (5 volumes, 1989-1995)

Review of EPA’s Environmental Monitoring and Assessment Program (3 volumes, 1994-1995)

Science and Judgment in Risk Assessment (1994)

Pesticides in the Diets of Infants and Children (1993)

Dolphins and the Tuna Industry (1992)

Science and the National Parks (1992)

Human Exposure Assessment for Airborne Pollutants (1991)

Rethinking the Ozone Problem in Urban and Regional Air Pollution (1991)

Decline of the Sea Turtles (1990)

Copies of these reports may be ordered from the National Academies Press

(800) 624-6242 or (202) 334-3313

www.nap.edu

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Preface

Biomonitoring has various applications; the focus in this report is on the role of biomonitoring as an exposure-assessment tool, which is central to public-health efforts. Repeatedly throughout recent history, biomonitoring data have helped to confirm health effects of environmental exposures and have validated public-health policies. Population-based biomonitoring studies have identified new chemicals found in the environment and in human tissues, monitored changes in exposures, and established the distribution of exposures among the general population. Biomonitoring data— when used in conjunction with available epidemiology, toxicology, and pharmacokinetic modeling data—can estimate how much of a chemical has been absorbed into the body and provide a measure of potential health risk. The ultimate objective of biomonitoring is to link information on exposures, susceptibility, and effects to understand the public health implications of exposure to environmental chemicals.

In spite of its potential, tremendous challenges surround the use of biomonitoring, and our ability to generate biomonitoring data has exceeded our ability to interpret what the data mean to public health. The challenges include improving the design of biomonitoring studies, interpreting what biomonitoring data mean, and understanding ethical and communication issues that are essential to the continued advancement of this field. To address the challenges, Congress asked the National Academies to assess key uncertainties related to the use and interpretation of biomonitoring data.

In this report, the Committee on Human Biomonitoring for Environmental Toxicants reviews current practices and makes recommendations for

Suggested Citation:"Front Matter." National Research Council. 2006. Human Biomonitoring for Environmental Chemicals. Washington, DC: The National Academies Press. doi: 10.17226/11700.
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improving the interpretation and uses of human biomonitoring data. The committee also develops a research agenda that addresses the key uncertainties in the field and provides guidance for collecting and interpreting biomonitoring data in the future.

This report has been reviewed in draft form by persons chosen for their diverse perspectives and technical expertise in accordance with procedures approved by the National Research Council’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards of objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following for their review of this report: Asa Bradman, University of California, Berkeley; Ludwine Casteleyn, Ministry of the Flemish Community; Harvey Clewell, CIIT Centers for Health Research; Kannan Krishnan, University of Montreal; Philip Landrigan, Mount Sinai School of Medicine; Michael Morgan, University of Washington; Joseph Rodricks, ENVIRON International Corporation; Kenneth Rothman, Harvard School of Public Health; Susan Santos, FOCUS Group; Paul Schulte, National Institute for Occupational Safety and Health; H. Catherine Skinner, Yale University; Karel Van Damme, University of Leuven; and Jean-Philippe Weber, Institut National de Santé Publique du Québec.

Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations, nor did they see the final draft of the report before its release. The review of this report was overseen by the review coordinator Steven Tannenbaum, Massachusetts Institute of Technology, and the review monitor, Johanna Dwyer, Tufts University. Appointed by the National Research Council, they were responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the committee and the institution.

The committee gratefully acknowledges the following for making presentations and for providing information: Harold Zenick, U.S. Environmental Protection Agency; Larry Needham, Jim Pirkle, John Osterloh, Susan Schober, Thomas Sinks, and Edward Thompson, Centers for Disease Control and Prevention; Paul Schulte, National Institute for Occupational Safety and Health; Richard Jackson, University of California, Berkeley; James VanDerslice, Washington State Department of Health; Richard Becker, American Chemistry Council; Steven Robison, Procter and Gamble Company; Lauren DiSano, Association of Public Health Laboratories; Angelina

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Duggan, CropLife America; Lorne Garretson, Environmental Defense; and Nancy Kass, Johns Hopkins Bloomberg School of Public Health.

The committee is also grateful for the assistance of the National Research Council staff in preparing this report. Staff members who contributed to this effort are Eileen Abt, project director; James Reisa, director of the Board on Environmental Studies and Toxicology; Jennifer Saunders, associate program officer; Norman Grossblatt, senior editor; Mirsada Karalic-Loncarevic, research associate; Lucy Fusco, program associate; Morgan Motto, senior project assistant; and Kemi Yai, project assistant.

I would especially like to thank the members of the committee for their efforts throughout the development of this report.

Thomas Burke, Chair

Committee on Human Biomonitoring for Environmental Toxicants

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 Properties of and Grouping Framework for Biomarkers of Exposure,

 

75

   

 Conclusions,

 

82

   

 Recommendations,

 

82

   

 References,

 

82

4

 

CONSIDERATIONS IN THE DESIGN OF BIOMONITORING STUDIES

 

84

   

 Study Design,

 

86

   

 Study Conduct,

 

110

   

 Statistical Analysis,

 

121

   

 Summary and Conclusions,

 

124

   

 Recommendations,

 

125

   

 References,

 

127

5

 

INTERPRETATION OF BIOMONITORING RESULTS

 

132

   

 Introduction,

 

132

   

 Initial Review of Biomonitoring Data,

 

133

   

 Overview of Interpretive Options for Biomonitoring Data,

 

134

   

 Reference Ranges,

 

139

   

 Adapting Workplace Biologic Reference Values for Interpreting Biomonitoring Results,

 

151

   

 Using Biomonitoring Results to Estimate Risk,

 

158

   

 Biomonitoring-Based Risk Assessment,

 

159

   

 Using Existing Risk Assessments for Interpreting Biomonitoring Data,

 

163

   

 Biomonitoring-Led Risk-Assessment Approaches,

 

164

   

 Summary,

 

185

   

 Conclusions,

 

190

   

 Recommendations,

 

192

   

 References,

 

193

6

 

COMMUNICATING RESULTS, INTERPRETATIONS, AND USES OF BIOMONITORING DATA TO NONSCIENTISTS

 

201

   

 Limits of This Chapter’s Discussion,

 

202

   

 Principles of Risk Communication,

 

205

   

 Trading Off Avoidance of False Positives and False Negatives in Communication,

 

211

   

 Discussing Results Below the Limit of Detection for Biomarkers,

 

213

   

 Communicating Health Interpretations of Detected Biomarkers,

 

214

   

 Recommendations,

 

227

   

 References,

 

233

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Boxes, Figures, and Tables

BOXES

3-1

 

Continuum of Risk-Assessment and -Management Activities Related to Exposure Biomonitoring,

 

74

5-1

 

Case Example: Organophosphorus Metabolites in Pregnant Farm Workers,

 

145

5-2

 

Reference Ranges Encourage Public-Health Action,

 

150

5-3

 

Potential Utility of Pilot Data from “Other” Populations,

 

150

5-4

 

Brief Overview of Pharmacokinetic Models,

 

165

FIGURES

1-1

 

Simplified flow chart of classes of biomarkers,

 

22

2-1

 

Timeline of major U.S. biomonitoring efforts,

 

29

3-1

 

Operational relationships between internal dose, external dose, and biologic effects,

 

76

4-1

 

Stages of a biomonitoring study,

 

86

4-2

 

Contribution of exposures to biomarker concentrations and effect of limit of detection on its potential uses,

 

88

4-3

 

Effect of half-life on contributions of exposures during the last presampling hour, day, week, month, and half-year to biologic levels of determinants,

 

92

4-4

 

Influence of biologic half-life relationship between exposure level and biomarker level,

 

93

Suggested Citation:"Front Matter." National Research Council. 2006. Human Biomonitoring for Environmental Chemicals. Washington, DC: The National Academies Press. doi: 10.17226/11700.
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4-5

 

Pharmacokinetics of environmental chemicals in body and what matrices are available for analyses,

 

111

5-1

 

Overview of interpretive options for biomonitoring data,

 

133

5-2

 

Illustration of the interpretive risk-based options,

 

136

5-3

 

Distribution of biomarker concentrations in generic reference population,

 

143

5-4

 

Cumulative frequency distribution of the urinary excretion of 1-hydroxypyrene in people living in two rural districts of Burundi, in Bujumbura and in a reference group at the University of Montreal,

 

146

5-5

 

Daily average workplace xylene air and urinary methylhippuric acid in exposed workers,

 

155

5-6

 

Evolution of risk assessment and risk management,

 

160

5-7

 

Conversion of biomonitoring data to daily dose on the basis of one- compartment (body-burden) model,

 

166

5-8

 

Blood concentrations of rapidly cleared chemical to which there is frequent and nearly uniform exposure,

 

167

5-9

 

Conversion of biomonitoring data to daily dose on basis of one-compartment model for non-lipid-soluble chemicals at steady state,

 

168

5-10

 

Predictiveness of PFOA rat model,

 

177

5-11

 

Median concentrations of BDE-47, BDE-99, and BDE-153 in human milk from different countries,

 

184

TABLES

1-1

 

Numbers of Chemicals in Third National Report on Human Exposures to Environmental Chemicals for Which Health-Based Values Are Available,

 

20

1-2

 

Challenges to Interpreting and Using Biomonitoring Data,

 

21

2-1

 

Examples of Current U.S. and International Biomonitoring Efforts,

 

32

3-1

 

Framework for Grouping Biomarkers of Exposure,

 

77

4-1

 

Goal-Based and Process-Based Criteria for Evaluating Communication,

 

108

4-2

 

Matrices for Biomonitoring Studies,

 

112

5-1

 

Overview of Major Biomarker Case Examples Used to Illustrate Interpretive Options,

 

138

5-2

 

Blood Concentrations for Cadmium in the U.S. Population Aged 1 Year and Older,

 

140

5-3

 

Urine Concentrations for Cadmium in the U.S. Population Aged 6 Years and Older,

 

142

Suggested Citation:"Front Matter." National Research Council. 2006. Human Biomonitoring for Environmental Chemicals. Washington, DC: The National Academies Press. doi: 10.17226/11700.
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5-4

 

Comparison of Biomarker Reference Values Proposed by ACGIH and Observed Concentrations in Adults for Same Determinants from NHANES 1999-2002,

 

152

5-5

 

Estimated Exposures (µg/kg/day) to the General Population Based on Extrapolated Intake from Urinary Metabolites in 289 Individuals Measured by Blount et al. (2000),

 

170

5-6

 

Properties of Biomarkers Used as Examples in Chapter 5,

 

188

7-1

 

Summary of Major Points in Research Agenda,

 

252

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Suggested Citation:"Front Matter." National Research Council. 2006. Human Biomonitoring for Environmental Chemicals. Washington, DC: The National Academies Press. doi: 10.17226/11700.
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Biomonitoring—a method for measuring amounts of toxic chemicals in human tissues—is a valuable tool for studying potentially harmful environmental chemicals. Biomonitoring data have been used to confirm exposures to chemicals and validate public health policies. For example, population biomonitoring data showing high blood lead concentrations resulted in the U.S. Environmental Protection Agency's (EPA's) regulatory reduction of lead in gasoline; biomonitoring data confirmed a resultant drop in blood lead concentrations. Despite recent advances, the science needed to understand the implications of the biomonitoring data for human health is still in its nascent stages. Use of the data also raises communication and ethical challenges. In response to a congressional request, EPA asked the National Research Council to address those challenges in an independent study. Human Biomonitoring for Environmental Chemicals provides a framework for improving the use of biomonitoring data including developing and using biomarkers (measures of exposure), research to improve the interpretation of data, ways to communicate findings to the public, and a review of ethical issues.

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