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RADIATION DOSE RECONSTRUCTION for Epidemiologic Uses Committee on an Assessment of CDC Radiation Studies Board on Radiation Effects Research Commission on Life Sciences National Research Council National Academy Press Washington, D.C. 1995
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NATIONAL ACADEMY PRESS 2101 CONSTITUTION AVENUE, N.W., WASHINGTON, D.C. 20418 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 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. This project was prepared under contract 200-91-0951 between the National Academy of Sciences and the Centers for Disease Control and Prevention. Library of Congress Cataloging-in-Publication Data Radiation dose reconstruction for epidemiologic uses / Committee on an Assessment of CDC Radiation Studies, Board on Radiation Effects Research, Commission on Life Sciences, National Research Council. p. cm. Includes bibliographical references and index. ISBN 0-309-05099-5 1. Radiation injuries—Epidemiology—Statistical Methods. 2. Radiation dosimetry. I. National Research Council (U.S.). Committee on an Assessment of CDC Radiation Studies. RA569.R25 1995 616.9'897—dc20 95-10524 Copyright 1995 by the National Academy of Sciences. All rights reserved. Printed in the United States of America
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COMMITTEE ON AN ASSESSMENT OF CDC RADIATION STUDIES WILLIAM J. SCHULL (Chairman), University of Texas, Houston, Texas STEPHEN A. BENJAMIN, Colorado State University, Ft. Collins, Colorado ANDRÉ BOUVILLE, National Cancer Institute, Bethesda, Maryland GEOFFREY G. EICHHOLZ, Georgia Institute of Technology, Atlanta, Georgia J. CHARLES JENNETT, Clemson University, Clemson, South Carolina LEEKA I. KHEIFETS, Electric Power Research Institute, Palo Alto, California JAMES E. MARTIN, University of Michigan, Ann Arbor, Michigan CHRISTOPHER B. NELSON, Environmental Protection Agency, Washington, D.C. HENRY D. ROYAL, Washington University Medical Center, St. Louis, Missouri ROY E. SHORE, New York University Medical Center, New York, New York ROBERT G. THOMAS, Argonne National Laboratory (ret.), Argonne, Illinois HENRY N. WAGNER, JR., The Johns Hopkins Medical Institutes, Baltimore, Maryland JAMES M. WALL, The Christian Century, Chicago, Illinois National Research Council Staff EVAN B. DOUPLE, Study Director MAURITA DOW-MASSEY, Project Assistant DORIS E. TAYLOR, Staff Assistant SPONSOR'S PROJECT OFFICER JAMES M. SMITH, Centers for Disease Control and Prevention
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BOARD ON RADIATION EFFECTS RESEARCH WARREN K. SINCLAIR (Chairman), National Council on Radiation Protection and Measurements (ret.), Bethesda, Maryland DOUGLAS GRAHN, Argonne National Laboratory (ret.), Madison, Indiana (member until June 30, 1994) ERIC J. HALL, Columbia University, New York, New York (member until June 30, 1994) MAUREEN M. HENDERSON, Fred Hutchinson Cancer Research Center and the University of Washington, Seattle, Washington LEONARD S. LERMAN, Massachusetts Institute of Technology, Cambridge, Massachusetts JOHN B. LITTLE, Harvard University, Cambridge, Massachusetts JONATHAN M. SAMET, The John Hopkins University, Baltimore, Maryland WILLIAM J. SCHULL, University of Texas Health Science Center, Houston, Texas (member as of July 1, 1994) THOMAS S. TENFORDE, Battelle, Pacific Northwest Laboratories, Richland, Washington SUSAN S. WALLACE, University of Vermont, Burlington, Vermont (member as of July 1, 1994) H. RODNEY WITHERS, UCLA Medical Center, Los Angeles, California National Research Council Staff JOHN D. ZIMBRICK, Director CHARLES W. EDINGTON, Director, RERFP EVAN B. DOUPLE, Senior Program Officer LARRY H. TOBUREN, Senior Program Officer CATHERINE S. BERKLEY, Administrative Associate MAURITA DOW-MASSEY, Project Assistant DORIS E. TAYLOR, Staff Assistant LARA V. ADAMO, Project Assistant/Secretary (as of October 17, 1994)
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COMMISSION ON LIFE SCIENCES THOMAS D. POLLARD (Chairman), Johns Hopkins Medical School, Baltimore, Maryland BRUCE N. AMES, University of California, Berkeley, California JOHN C. BAILAR III, McGill University, Montreal, Canada J. MICHAEL BISHOP, University of California Medical Center, San Francisco, California JOHN E. BURRIS, Marine Biological Laboratory, Woods Hole, Massachusetts MICHAEL T. CLEGG, University of California, Riverside, California GLENN A. CROSBY, Washington State University, Pullman, Washington MARIAN E. KOSHLAND, University of California, Berkeley, California RICHARD E. LENSKI, Michigan State University, East Lansing, Michigan EMIL A. PFITZER, Hoffmann-La Roche Inc., Nutley, New Jersey MALCOLM C. PIKE, University of Southern California, School of Medicine, Los Angeles, California HENRY C. PITOT III, University of Wisconsin, Madison, Wisconsin JONATHAN M. SAMET, The Johns Hopkins University, Baltimore, Maryland HAROLD M. SCHMECK, JR., North Chatham, Massachusetts CARLA J. SHATZ, University of California, Berkeley, California SUSAN S. TAYLOR, University of California, San Diego, La Jolla, California P. ROY VAGELOS, Merck & Co., Inc., Whitehouse Station, New Jersey JOHN L. VANDEBERG, Southwest Foundation for Biomedical Research, San Antonio, Texas National Research Council Staff PAUL GILMAN, Executive Director ALVIN G. LAZEN, Associate Executive Director
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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. Bruce M. Alberts 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. Robert M. White 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. Kenneth I. Shine 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. Bruce M. Alberts and Dr. Robert M. White are chairman and vice chairman, respectively, of the National Research Council.
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Preface AS PUBLIC CONCERN MOUNTS over past and current exposure to ionizing radiation stemming from environmental releases of radioactive materials, there is a growing need to define the criteria to be met by studies that reconstruct exposures and doses and to provide guidance in the studies' epidemiologic use. Absent this, dose reconstruction studies are not likely to stand serious scientific scrutiny or to meet public concerns. To assist the Centers for Disease Control and Prevention (CDC) in the continuing dose reconstruction efforts at several U.S. nuclear facilities, the members of the National Research Council's Committee on an Assessment of CDC Radiation Studies and officers at the CDC believed it was timely to convene a group of scientists with experience and expertise relevant to the dozens of major dose reconstruction projects around the world that have followed radiation exposures of human populations. The scientists were asked to assist the committee in identifying criteria to be considered when undertaking radiation dose reconstruction studies, to examine the pitfalls encountered in previous studies, and to recommend areas of needed research. This report should set the objectives to be attained by such studies and provide guidelines for their conduct. It is aimed at providing generic information to scientists entering the field and to interested members of the public. The National Research Council committee is indebted to the numerous scientists from around the world who agreed to participate in the Workshop on Dose Reconstruction for Epidemiologic Uses, which was held in Washington, D.C., Oct. 25–27, 1993. The document that follows
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was synthesized by these scientists who, working with the committee, put into writing their thoughts and experiences. This final document was edited by the National Research Council committee and was subjected to the Research Council's rigorous and independent review process. It is important to emphasize that this version has not been reviewed by all of the participants and that it does not claim to represent a consensus of the workshop participants. The committee realizes that it would be impractical to achieve such extensive review and consensus, given the large number of participants. However, the committee believes this document captures the enthusiasm and conscientiousness displayed by the participants. It is a reasonably accurate record of their thoughts, it defines a valuable set of criteria, and it provides recommendations that will prove useful in future dose reconstruction studies in the United States and elsewhere. We are deeply appreciative of the work of the staff of the Board on Radiation Effects Research, and particularly the assistance of Doris Taylor and Maurita Dow-Massey in the preparation of this report. We thank Mrs. Kate Kelly for her editorial review. WILLIAM J. SCHULL Chairman
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Contents EXECUTIVE SUMMARY 1 1 BACKGROUND 4 2 INTRODUCTION 7 Elements of Dose Reconstruction 8 Technical Aspects of Dose Reconstruction 9 Structure of a Scoping Study 11 Public Involvement 13 Summary and Recommendations 14 3 ESTIMATING AND CONFIRMING THE SOURCE TERM 16 Approach to Source Term Analysis 17 Data Requirements for Source Term Analysis 19 Episodic Releases 21 Sources of Information 22 Bias and Uncertainty in Release Estimates 23 Gaps in Release Data 24 Summary and Recommendations 25 4 ENVIRONMENTAL PATHWAYS 27 Transport of Radionuclides and Other Contaminants 28 Further Consideration 36 Summary and Recommendations 38
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5 RADIATION DOSE ASSESSMENT 40 Sources of Exposure 40 Potential Consequences of Radiation Exposure 42 Preliminary Dose Assessment 44 Comprehensive Dose Assessment 46 Individual Dose Assessment 48 Uncertainty 48 Summary and Recommendations 49 6 BIOLOGIC DOSIMETRY AND BIOLOGIC MARKERS 51 Markers of Exposure and Dose 52 Markers of Effect 57 Markers of Susceptibility 58 Markers in Retrospective Dosimetry 58 Markers in Epidemiology 59 Summary and Recommendations 60 7 EPIDEMIOLOGIC CONSIDERATIONS 62 Quantitative Risk Assessment: Strengths and Limitations of Epidemiology Studies 63 Epidemiology and Dose Reconstruction 67 Study Design 68 Summary and Recommendations 78 8 PRIORITY CRITERIA FOR DOSE ASSESSMENT STUDIES 82 Basic Criteria 83 Decision Criteria 84 Final Ranking 84 Summary and Recommendations 85 9 CONCLUSIONS 87 10 LITERATURE CITED 93 APPENDIXES A Representative Dose Reconstruction Studies 103 B Workshop Agenda 112 C Workshop Participants 125 D Glossary 125 INDEX 133
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RADIATION DOSE RECONSTRUCTION for Epidemiologic Uses
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