Environmental Epidemiology

Volume 2

Use of the Gray Literature and Other Data in Environmental Epidemiology

Committee on Environmental Epidemiology

and

Commission on Life Sciences

National Research Council


NATIONAL ACADEMY PRESS
Washington, D.C.
1997



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--> Environmental Epidemiology Volume 2 Use of the Gray Literature and Other Data in Environmental Epidemiology Committee on Environmental Epidemiologyand Commission on Life Sciences National Research Council NATIONAL ACADEMY PRESS Washington, D.C. 1997

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--> NATIONAL ACADEMY PRESS 2101 Constitution Ave., NW Washington, DC 20418 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 competencies and with regard for appropriate balance. This report has been reviewed by a group other than the authors according to procedures approved by a Report Review Committee consisting of members of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. International Standard Book Number 0-309-05737-X Library of Congress Catalog Card Number 91-28051 Cover photograph: LES MOORE/UNIPHOTO Copyright 1997 by the National Academy of Sciences. All rights reserved. Printed in the United States of America

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--> COMMITTEE ON ENVIRONMENTAL EPIDEMIOLOGY ANTHONY B. MILLER (Chairman), University of Toronto, Toronto, ON, Canada DAVID BATES, University of British Columbia, Vancouver, BC, Canada THOMAS CHALMERS, Department of Veterans Affairs and Harvard School of Public Health (deceased December 1995) JOHN FROINES, UCLA School of Public Health, Los Angeles, CA DAVID HOEL, Medical University of South Carolina, Charleston, SC JAMES MELIUS, New York State Department of Health, Albany, NY JOEL SCHWARTZ, Harvard University School of Public Health, Cambridge, MA LYNN GOLDMAN, US Environmental Protection Agency, was a member of the committee until February 1994 Special Advisers ROBERT MORRIS, Medical College of Wisconsin, Milwaukee, WI PAUL SCHULTE, National Institute for Occupational Safety and Health, Cincinnati, OH DIANE WAGENER, National Center for Health Statistics, Hyattsville, MD Staff DEVRA LEE DAVIS, Scholar in Residence until June 1993 LINDA MILLER POORE, Research Associate AMY REDMON, Editor NORMAN GROSSBLATT, Editor PAULETTE ADAMS, Project Assistant The Committee on Environmental Epidemiology (listed above) prepared the original version of this report. The Commission on Life Sciences of the National Research Council, whose membership is shown on the next page, completed the report. All members of the Committee on Environmental Epidemiology agreed to the present content of the report.

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--> COMMISSION ON LIFE SCIENCES THOMAS D. POLLARD (Chairman), Johns Hopkins Medical School, Baltimore, MD FREDERICK R. ANDERSON, Cadwalader, Wickersham & Taft, Washington DC JOHN C. BAILAR III, University of Chicago, Chicago, IL PAUL BERG, Stanford University, Palo Alto, CA JOHN E. BURRIS, Marine Biological Laboratories, Woods Hole, MA SHARON L. DUNWOODY, University of Wisconsin, Madison, WI URSULA W. GOODENOUGH, Washington University, St. Louis, MO HENRY W. HEIKKENEN, University of Northern Colorado, Greeley, CO HANS J. KENDE, Michigan State University, East Lansing, MI SUSAN E. LEEMAN, Boston University, Boston, MA THOMAS E. LOVEJOY, Smithsonian Institution, Washington, DC DONALD R. MATTISON, University of Pittsburgh, Pittsburgh, PA JOSEPH E. MURRAY, Wellesley Hills, MA EDWARD E. PENHOET, Chiron Corporation, Emeryville, CA EMIL A. PFITZER, Research Institute for Fragrance Materials, Inc., Hackensack, NJ MALCOLM C. PIKE, USC School of Medicine, Los Angeles, CA HENRY PITOT III, University of Wisconsin, Madison, WI JONATHAN M. SAMET, Johns Hopkins University, Baltimore, MD CHARLES F. STEVENS, The Salk Institute for Biological Studies, La Jolla, CA JOHN L. VANDEBERG, Southwestern Foundation for Biomedical Research, San Antonio, TX National Research Council Staff PAUL GILMAN, Executive Director ALVIN G. LAZEN, Associate Executive Director SOLVEIG M. PADILLA, Administrative Assistant

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--> Preface VOLUME 1 OF Environmental Epidemiology was published in 1991 and has helped to define a field that seeks to clarify the relationship between exposure to physical, biologic, and chemical agents in the environment and human health. That report examined and evaluated the published scientific literature on health effects that could be linked with exposure to hazardous-waste sites and presented recommendations about filling major data gaps in order to advance the field. In preparing volume 2, the Committee on Environmental Epidemiology set out to address important issues that were introduced in volume 1, such as the use of biomarkers and principles for drawing inferences from epidemiologic studies. The effects of exposure to an environmental agent can be hard to detect. The populations that have been exposed to the agent at a specific site are often small and the amount of exposure hard to determine. Only small changes in incidence of a disease may have occurred—so small as to make it difficult to determine clearly whether an association exists between the environmental exposure and the effect observed. Yet it is of great public-health importance to know if effects are occurring. Large numbers of people at many different sites may be exposed to the same environmental agent. Small effects detected in a small population could mean that a larger number exposed in the total population are at risk. Volume 2 continues the discussion of environmental epidemiology by examining ways to improve the chances of detecting an effect if one is occurring. Thus, the report focuses on improving how we measure exposure and how we apply the standard methods of epidemiologic research. The committee also examines the so-called gray litera-

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--> ture—reports that have not been published in journals after peer-review but may contain valuable clues about possible hazards to human health. These gray literature reports are often from state and local public-health groups and have usually been reviewed locally. The committee that prepared volume 1 also prepared the bulk of the report that follows. In particular, it did the long and arduous work of reviewing a collection of gray-literature reports to determine how useful these might be in helping to understand the effects of environmental exposure. They also prepared the original versions of all other chapters. Unfortunately, long delays occurred in the latter stages of the study process, and the original committee could not complete the report. Responsibility for completion was then assumed by the Commission on Life Sciences of the National Research Council, the oversight body for the Committee on Environmental Epidemiology. Thus, though the original committee deserves the gratitude of the scientific community for initiating the preparation of this report and for its initial work, the Commission takes responsibility on behalf of the National Research Council for the contents of the report along with the original committee. Special thanks are due to those members of the Commission—John Bailar, Malcolm Pike, and Jonathan Samet—who played the central role on behalf of the Commission. We acknowledge the efforts of and thank the Committee on Environmental Epidemiology and the staff of that committee. Their names are listed in the front of this report. We also thank the Agency for Toxic Substances and Disease Registry, sponsor of the study, for its support. THOMAS D. POLLARD, CHAIRMAN COMMISSION ON LIFE SCIENCES

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--> Contents Chapter 1   Environmental Epidemiology: The Context   1     Introduction   2     Definition of Environmental Epidemiology   3     Purview of This Report   3     Structure of This Report   5     Special Issues for the Study of Environmental Epidemiology   5     The Role of Public-Health Departments in Environmental Epidemiology Research   7     Conclusions   9     References   10 Chapter 2   Environmental-Epidemiology Studies: Their Design and Conduct   12     Origins of Epidemiology   12     Types of Studies in Environmental Epidemiology   13     Special Considerations   19     Causal Inference in Epidemiology   22     References   24 Chapter 3   Exposure Assessment in Environmental Epidemiology   26     Principal Concepts That Underlie the Content of This Chapter   28     Concept and Method in Exposure Assessment   28

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-->     Exposure-Data Needs for Epidemiology Studies   31     Issues in Exposure Assessment   42     The Need for Improvement in Exposure Assessment   44     Air-Pollution Studies and Exposure Assessment   47     Exposure Assessment at Hazardous-Waste Sites   49     Assessment of Past Exposure   49     Complex Mixtures   50     Indexes of Exposure   51     Subjective Symptoms and Exposure Assessment   54     Use of Biologic Markers of Exposure   56     Dosimetric Modeling   58     Training in Environmental-Exposure Assessment   60     Conclusions   60     References   62 Chapter 4   Researching a Broad Range of Health Outcomes   68     Respiratory Outcomes   69     Neurologic Outcomes   73     Reproductive and Developmental Outcomes   76     Hepatic and Renal Outcomes   80     Immunologic Effects   80     Biologic Markers in Environmental Epidemiology   81     Susceptible Populations   84     Recommendations   85     References   87 Chapter 5   Data Systems and Opportunities for Advances   94     Introduction   94     Data-Collection Systems: What They Measure   96     Bridging Environment and Health   107     Monitoring of Environmental-health Effects   112     Confidentiality and Needs for Personal Identifiers   120     Data Gaps, Resource Constraints, and Research Opportunities   123     References   127 Chapter 6   Opportunities for Methodologic Advances in Data Analysis   130     Introduction   131     Analysis of Discrete Outcomes   132     Analysis of Correlated Data   133     Analysis of Data When the Shape of the Dose Response Relation Is Unknown   142

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-->     Robust Methods   144     Modeling Exposure   145     Conclusions   149     References   150 Chapter 7   Review of the Gray Literature from State Reports   154     Introduction   154     Review of Gray Literature   155     State Studies of Reproductive End Points   162     Reports From Other Countries   170     References   171 Chapter 8   Major Conclusions and Recommendations   173     Conclusions and Recommendations Concerning The Grey Literature   174     Conclusions and Recommendations on Methodologic Issues   176     Index   181

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