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A Review of the Draft Report of the NCI-CDC Working Group to Revise the ~ 985 Raclioepidemiologicat Tables Committee on an Assessment of Centers for Disease Control and Prevention Radiation Studies from DOE Contractor Sites: Subcommittee to Review Radioepidemiological Tables Board on Radiation Effects Research Commission on Life Sciences National Academy of Sciences National Acaclemy Press Washington, D.C.

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NATIONAL ACADEMY PRESS 2101 CONSTITUTION AVENUE, 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 competences and with regard to appropriate balance. This report was prepared under the Centers for Disease Control and Prevention contract 200-95- 0965 between the National Academy of Sciences and the Centers for Disease Control and Prevention. International Standard Book Number 0-309-07250-6 A limited number of copies of this report are available from the: National Research Council Board on Radiation Effects Research 2101 Constitution Avenue, NW Washington, DC 20418 (202) 334-2232 Copyright 2000 by the National Academy of Sciences. All rights reserved. Pnnted in the United States of America .

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National Academy of Sciences National Academy of Engineering institute of Medicine National Research Council 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. William 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. Kenneth T. 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. William A. Wulf are chairman and vice chairman, respectively, of the National Research Council. . . .

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COMMITTEE ON AN ASSESSMENT OF CENTERS FOR DISEASE CONTROL AND PREVENTION RADIATION STUDIES FROM DOE CONTRACTOR SITES: SUBCOMMITTEE TO REVIEW THE RADIOEPIDEMIOLOGY TABLES WILLIAM I. SCHULL (Chair9, Emeritus Professor, University of Texas-Houston, Houston, TX SHARON M. FRIEDMAN, Lehigh University, Bethlehem, PA PETER G. GROER, The University of Tennessee, Knoxville, TN SUSAN E. LEDERER, Yale University School of Medicine, New Haven CT ROY E. SHORE, New York University Medical Center, New York, NY DANIEL O. STRAM, University of Southern California, Los Angeles, CA DUNCAN C. THOMAS, University of Southern California, Los Angeles, CA DANIEL WARTENBERG, Robert Wood Johnson Medical School, Piscataway, N] JOHN S. YOUNG, The Hampshire Research Institute, Alexandria, VA CLS ADVISER BARABARA S. HUI~KA, University of North Carolina at Chapel Hill, NC NATIONAL RESEARCH COUNCIL STAFF ISAF AL-NABULSI, Study Director BRIDGET R. EDMONDS, Project Assistant DORIS E. TAYI~OR, Staff Assistant SPONSOR 'S PROJECT OFFICER JAMES SMITH, Centers for Disease Control and Prevention EDITOR NORMAN GROSSBLATT 1V

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BOARD ON RADIATION EFFECTS RESEARCH R.J. MICHAEL FRY (Chair), Oak Ridge National Laboratory, Oak Ridge, TN S. JAMES ADELSTEINt, Harvard Medical School, Boston, MA VALERIE BERAL, University of Oxford, United Kingdom SARAH S. DONALDSON:, Stanford University Medical Center, Stanford, CA EDWARD R. EPP, Professor Emeritus, Harvard University, Boston, MA HELEN H. EVANS, Case Western Reserve University, Cleveland, OH WILLIAM F. MORGAN, The University of Maryland, Baltimore, MD FRANKLYN G. PRENDERGAST, Mayo Clinic Cancer Center, Rochester, MN DANIEL O. STRAM, University of Southern California, Los Angeles, CA NATIONAL RESEARCH COUNCIL STAFF EVAN B. DOUPLE, Director, Board on Radiation Effects Research RICK 'TOSTES, Senior Program Officer ISAF AL-NABULST, Program Officer CATHERINE S. BERKLEY, Administrative Associate BRIDGET R. EDMONDS, Project Assistant BENJAMIN HAMLIN, Project Assistant (effective 10/00) DORIS E. TAYLOR, Staff Assistant Member of TOM v

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COMMISSION ON LIFE SCIENCES MICHAEL T. CLEGG (Chair), University of California, Riverside, CA PAUL BERG (Vice Chair), Stanford University School of Medicine, Stanford, CA FREDERICK R. ANDERSON, Cadwalader, Wickersham & Taft, Washington, DC JOANNA BURGER, Rutgers University, Piscataway, N] JAMES E. CLEAVER, UCSF Cancer Center, San Francisco, CA DAVID S. ElSENBERG, University of California, Los Angeles, CA NEAL L. FIRST, University of Wisconsin, Madison, WI DAVID IT. GALAS, Keck Graduate Tnstitute of Applied Life Science, Claremont, CA DAVID V. GOEDDEL, Tularik, Inc., South San Francisco, CA ARTURO GOME~POMPA, University of California, Riverside, CA COREY S. GOODMAN, University of California, Berkeley, CA JON W. GORDON, Mount Sinai School of Medicine, New York, NY DAVID G. HOEL, Medical University of South Carolina, Charleston, SC BARBARA S. HULKA, University of North Carolina at Chapel Hill, NC CYNTHIA J. KENYON, University of California, San Francisco, CA BRUCE R. LEVIN, Emory University, Atlanta, GA DAVID M. LIVINGSTON, Dana-Farber Cancer Tnstitute, Boston, MA DONALD R. MATTTSON, March of Dimes, White Plains, NY ELLIOT M. MEYEROWITZ, California Tnstitute of Technology, Pasadena, CA ROBERT T. PAINE, University of Washington, Seattle, WA RONALD R. SEDEROFF, North Carolina State University, Raleigh, NC ROBERT R. SOKAL, State University of New York, Stony Brook, NY CHARLES F. STEVENS, The Salk Institute for Biological Studies, LaJolla, CA SHIRLEY M. TTLGHMAN, Princeton University, Princeton, N] RAYMOND L. WHITE, University of Utah, School of Medicine, Salt Lake City, UT NATIONAL RESEARCH COUNCIL STAFF WARREN R. MUIR, Executive Director V1

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PREFACE The National Research Council's Committee on the Assessment of the Centers for Disease Control and Prevention's Radiation Programs was called on to review the draft report of the NCI-CDC working group charged with revising the 1985 radioepidemiological tables. This report provides an assessment of the utility of the data sources used by the working group in their preparation of the revised tables, evaluation of the assumptions implicit in these tables concerning radiologic effects, the epidemiologic and biostatistical methods used in these tables and the means by which uncertainties were handled, and provides advice regarding how these tables should be made available to the public. The subcommittee members wish to thank the members of the working group who have contributed to their understanding of the revised tables and to their work. Drs. James M. Smith and Charles Miller of CDC provided a valuable perspective on the activities of the Radiation Studies Branch and useful historical insights for the subcommittee's study. Drs. Charles Land and Ethel Gilbert, of the Department of Health and Human Services (DHHS-N]H3, and Owen Hoffman, lulian Apostoaei, and Brian Thomas of SENES Oak Ridge, Inc., were generous with their time and thorough in discussing the strategy adopted in the revision of the radioepidemiological tables and in demonstrating the interactive computer program developed for computation of assigned shares. The subcommittee is especially grateful for the information provided by Dr. Neil Otchin, a representative of the Department of Veteran Affairs. The subcommittee thanks the National Research Council staff who worked with us, especially Dr. Isaf Al-NabuIsi for keeping the subcommittee focused and preparing several drafts of this report. She was well assisted in the administrative details related to the subcommittee's work by Bridget R. Edmonds and Doris E. Taylor. William J. Schull Chairman ~ V11

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ACKNOWLEDGMENTS This report has been reviewed in draft form by individuals 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 the published report as sound as possible and to ensure that the report meets institutional standards for 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 individuals for their participation in the review of this report: John D. Boice, International Epidemiology Institute, Rockville, MD Shirley A. Fry, Oak Ridge, TN Donald E. Jose, West Chester, PA Kenneth J. Kopecky, Fred Hutchinson Cancer Research Center, Seattle, WA Stephen Lagakos, Harvard University, Boston, MA 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 David G. Hoel, appointed by CES, who was 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 authoring subcommittee and the institution. 1X

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CONTENTS EXECUTIVE SUMMARY.................................................................................... 1. INTRODUCTION...................................................................................................... 2. SUMMARY OF THE SUBCOMMITTEE'S REPORT ........................................................ J. Utility of the Data Sources .......................................................................... Data Sources for Estimates of Uncertainties ............................................... Assumptions Concerning Radiologic Effects.............................................. Modeling and Choice of Parameters............................................................ A. TREATMENT OF ACUTE AND PROTRACTED (CHRONIC) EXPOSURES ........................ ASSESSMENT OF TIME SINCE EXPOSURE AS A MODIFIER OF RISK ........................... _ . 6. APPLICABILITY OF ASSIGNED SHARE CALCULATIONS TO MINORITY GROUPS 9 7. ESTIMATION OF ASSIGNED SHARE FOR NONMELANOMA SKIN CANCER 9 8. TREATMENT OF UNCERTAINTY 10 Monte Carlo Simulation 10 Residual Uncertainties and Use of a Scale Factor 12 9. HOW SHOULD THE RADIOEPIDEMIOLOGICAL TABLES BE MADE AVAILABLE TO THE PUBLIC? 13 Evaluation of the Interactive Radio-Epidemiological Program 13 Accessibility 14 Transparency 14 Flexibility 15 Over Ethical and Communication Issues 16 10. FUTURE REVISIONS AND BROADER ISSUES 19 Future Revisions 19 Broader Issues 20 Usefulness of Probability of Causation 20 Role of Uncertainty in Compensation 23 11. CONCLUSIONS AND RECOMMENDATIONS 27 Utility of Data Sources 27 Conclusion 27 Recommendations 27 Assumptions Concerning Radiologic Effects 27 Conclusion 27 Recommendations 28 Epidemiologic and Biostatistical Models 28 Conclusions 28 Recommendations 29 Handling of Uncertainty 30 Conclusions 30 Recommendations 31 Suggestions 32 Making the Radioepidemiological Tables Available to the Public 32 Conclusions 32 Recommendations 33 Suggestions 33 Z. SUGGESTIONS FOR FUTURE COMPENSATION POLICY 34 13. APPENDIX A: SPECIFIC COMMENTS ON THE WORKING GROUP'S DRAFT REPoRT 36 14. APPENDIX B: SPECIFIC COMMENTS ON THE INTERACTIVE RADIO-EPIDEMIOEOGICAE PROGRAM 38 Installation 38 ANALYTICA Constraints 39 IREP Choices in Implementation 39 Input Data 40 APPENDIX C: SUPPLEMENT TO TEXT 4 1 16. REFERENCES ~ 46 17. INFORMATION ON COMMITTEE MEMBERS 49 5. X1

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