ASSESSMENT OF THE SCIENTIFIC INFORMATION FOR THE RADIATION EXPOSURE SCREENING AND EDUCATION PROGRAM

Committee to Assess the Scientific Information for the Radiation Exposure Screening and Education Program

Board on Radiation Effects Research

Division on Earth and Life Studies

NATIONAL RESEARCH COUNCIL OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS
Washington, D.C.
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Assessment of the Scientific Information for the Radiation Exposure Screening and Education Program ASSESSMENT OF THE SCIENTIFIC INFORMATION FOR THE RADIATION EXPOSURE SCREENING AND EDUCATION PROGRAM Committee to Assess the Scientific Information for the Radiation Exposure Screening and Education Program Board on Radiation Effects Research Division on Earth and Life Studies NATIONAL RESEARCH COUNCIL OF THE NATIONAL ACADEMIES THE NATIONAL ACADEMIES PRESS Washington, D.C. www.nap.edu

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Assessment of the Scientific Information for the Radiation Exposure Screening and Education Program THE NATIONAL ACADEMIES PRESS 500 Fifth Street, N.W. Washington, DC 20001 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 study was supported by contract DHHS 232-02-0004 between the National Academy of Sciences and the Health Resources and Services Administration. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the views of the organizations or agencies that provided support for the project. International Standard Book Number: 0-309-09610-3 (Book) International Standard Book Number: 0-309-54931-0 (PDF) Library of Congress Control Number: 2005929472 Additional copies of this report are available from the National Academies Press, 500 Fifth Street, NW, Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu. Copyright 2005 by the National Academy of Sciences. All rights reserved. Printed in the United States of America.

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Assessment of the Scientific Information for the Radiation Exposure Screening and Education Program 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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Assessment of the Scientific Information for the Radiation Exposure Screening and Education Program COMMITTEE TO ASSESS THE SCIENTIFIC INFORMATION FOR THE RADIATION EXPOSURE SCREENING AND EDUCATION PROGRAM R. JULIAN PRESTON (Chair), Environmental Carcinogenesis Division, National Health and Environmental Effects Research Laboratory, US Environmental Protection Agency, Research Triangle Park, NC THOMAS B. BORAK, Department of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, CO CATHERINE BORBAS, Health Care Evaluation and Research Foundation, St. Paul, MN A. BERTRAND BRILL, Radiology Department, Vanderbilt University School of Medicine, Nashville, TN THOMAS E. BUHL, Health Safety and Radiation Protection Division, Los Alamos National Laboratory, Los Alamos, NM PATRICIA A. FLEMING, College of Arts and Sciences, Creighton University, Omaha, NE SHIRLEY A. FRY, Indiana University School of Medicine, Indianapolis, IN RICHARD HORNUNG, University of Cincinnati, Cincinnati, OH KATHLEEN N. LOHR, RTI International, Research Triangle Park, NC STEPHEN G. PAUKER, Tufts-New England Medical Center, Boston, MA CONSULTANT ELAINE RON, National Cancer Institute, Bethesda, MD NATIONAL RESEARCH COUNCIL STAFF ISAF AL-NABULSI, Study Director COURTNEY GIBBS, Program Assistant DORIS E. TAYLOR, Staff Assistant NORMAN GROSSBLATT, Senior Editor

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Assessment of the Scientific Information for the Radiation Exposure Screening and Education Program BOARD ON RADIATION EFFECTS RESEARCH S. JAMES ADELSTEIN (Chair), Harvard Medical School, Boston, MA HAROLD BECK, Environmental Sciences Division (ret.), New York, NY JOEL S. BEDFORD, Colorado State University, Fort Collins, CO JAMES E. CLEAVER, University of California San Francisco Cancer Center, San Francisco, CA SARAH S. DARBY, University of Oxford, Oxford, United Kingdom SARAH S. DONALDSON, (member until 7/31/2004), Stanford University Medical Center, Stanford, CA SHARON L. DUNWOODY, University of Wisconsin, Madison, WI EDWARD R. EPP, (member until 7/31/2004), Professor Emeritus, Harvard University, Boston, MA DANIEL KREWSKI, University of Ottawa, Ottawa, Canada C. CLIFTON LING, Memorial Sloan-Kettering Cancer Center, New York, NY WILLIAM F. MORGAN, (member until 7/31/2004), University of Maryland, Baltimore, MD THEODORE L. PHILLIPS, University of California, San Francisco, CA FRANKLYN G. PRENDERGAST, (member until 7/31/2004), Mayo Clinic Cancer Center, Rochester, MN ANDREW M. SESSLER, Lawrence Berkeley National Laboratory, Berkeley, CA JOHN C. VILLFORTH, Food and Drug Law Institute (ret.), Derwood, Maryland PAUL L. ZEIMER, Purdue University, West Lafayette, IN NATIONAL RESEARCH COUNCIL STAFF EVAN B. DOUPLE, Director, Board on Radiation Effects Research ISAF AL-NABULSI, Senior Program Officer RICK JOSTES, Senior Program Officer CATHERINE S. BERKLEY, Administrative Associate COURTNEY GIBBS, Program Assistant DORIS E. TAYLOR, Staff Assistant

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Assessment of the Scientific Information for the Radiation Exposure Screening and Education Program Acknowledgments During the committee’s deliberations, several people provided information to the committee. Their contributions invigorated committee deliberations and enhanced the quality of this report. The committee expresses its appreciation to the Health Resources and Services Administration (HRSA) for sponsoring the study. The committee and the staff of the Board on Radiation Effects Research (BRER) are grateful for the information provided by invited speakers, who generously contributed their time and participated in the committee’s information-gathering meetings: Rebecca Barlow, Alfred Berg, Evelyn Bromet, Douglas M. Brugge, Teresa Coons, Regan Crump, Gerard W. Fischer, David S. James, Richard Kerber, Kiyo Mabuchi, Parthiv Mahadevia, Kimberly Mohs, Karen Mulley, Linda Nelson, Lynne Pinkerton, Regina Ponder, Neil R. Powe, Nettie Prack, Kandace Romero, Steve Simon, Stephanie Singer, Sylvia Echave Stock, Bruce Struminger, Kathleen Taimi, Robert Ursano, and Steven H. Woolf. The committee is especially grateful for the information provided by downwinders and uranium miners throughout its work. They provided records, explained their concerns, and assisted us in understanding the conditions surrounding the nuclear-weapon tests and the mines. The committee and the BRER staff are appreciative of the information, feedback, and background materials for review provided by invited speakers, the public, the Department of Justice, and HRSA and its grantees. We hope that our work will help to generate changes in the Radiation Exposure Screening and Education Program and Radiation Exposure Compensation Act programs that will make them both more effective. Finally, the committee thanks the National Research Council staff who worked directly with us, especially Study Director Dr. Isaf Al-Nabulsi for her expertise, dedication, and hard work; for keeping the committee focused and assisting in the writing and preparation of our report; and for her enormous effort in producing a clearly written, well-organized report that reflects the thought of the committee. Dr. Al-Nabulsi was well assisted in the administration of the committee’s work by Courtney Gibbs, Doris E. Taylor, and Danielle B. Greene, Banneker-Anderson intern.

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Assessment of the Scientific Information for the Radiation Exposure Screening and Education Program Reviewers 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 purposes of this review are 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 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 participation in the review of this report: John C. Bailar III, The University of Chicago, Washington, DC Harold L. Beck, Environmental Sciences Division, New York, NY Joel S. Bedford, Colorado State University, Ft. Collins, CO Alfred O. Berg, University of Washington School of Medicine, Seattle, WA Bernard L. Cohen, University of Pittsburgh, Pittsburgh, PA Kenneth J. Kopecky, Fred Hutchinson Cancer Research Center, Seattle, WA Jonathan D. Moreno, University of Virginia, Charlottesville, VA Robert S. Lawrence, Johns Hopkins University, Baltimore, MD Fred A. Mettler, The University of New Mexico, Albuquerque, NM Jonathan M. Samet, Johns Hopkins University, Baltimore, MD Daniel O. Stram, University of Southern California, Los Angeles, CA John E. Till, Risk Assessment Corporation, Neeses, SC 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 Robert A. Frosch, John F. Kennedy School

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Assessment of the Scientific Information for the Radiation Exposure Screening and Education Program of Government, Harvard University (Senior Research Fellow) and William J. Schull, University of Texas, School of Public Health (Ashbel Smith Professor Emeritus). 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 authoring committee and the National Research Council.

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Assessment of the Scientific Information for the Radiation Exposure Screening and Education Program A Note on the Units of Measurement Used in this Report It has been the custom of the Board on Radiation Effects Research to use the International System of Units (SI) in its reports. The relationships between the units used in this report and the corresponding traditional units and special names are shown below. Decimal multiples and submultiples of the units also are used, for example, kilo (K = 1,000 or 103), mega (M = 1 million or 106), milli (m = 1/1,000 or 10−3), micro (µ = one millionth or 10−6), nano (n = one billionth or 10−9), and pico (p = one trillionth or 10−12). Concept Symbol Dimensions Units Conversion SI Traditional Radioactivity A Decays/time (Bq) Becquerel (Ci) Curie 1 Ci = 3.7 × 1010 Bq Absorbed dose D Energy/mass (Gy) Gray Rad 1 rad = 10−2 Gy Equivalent dose H = Dwr Energy/mass (Sv) Sievert Rem 1 rem = 10−2 Sv Effective dose E = HwT Energy/mass (Sv) Sievert Rem 1 rem = 10−2 Sv Working level WL Energy/volume Jm−3 WL 1 WL = 2.08 × 10−5 Jm−3 Working level month WLM Energy time/volume Jsm−3 WLM 1 WLM = 12.7 Jsm−3

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Assessment of the Scientific Information for the Radiation Exposure Screening and Education Program Contents     EXECUTIVE SUMMARY   1 1   INTRODUCTION   10      Science, Values, and Decision-Making,   15 2   LEGISLATION AND COMPENSATION   17      The Radiation Exposure Compensation Act,   17      Compensation in the Radiation Exposure Compensation Act,   27      Other Compensation Programs,   35      Conclusion,   42 3   BASIC CONCEPTS IN RADIATION PHYSICS, BIOLOGY, AND EPIDEMIOLOGY   43      Radiation Physics,   43      Radiation Biology,   54      Radiation Epidemiology,   61 4   REVIEW OF RECENT DATA ON RADIATION EPIDEMIOLOGY, BIOLOGY, AND DOSIMETRY   73      Recent Developments in Radiation Epidemiology,   74      Studies of Populations Occupationally Exposed to Radiation,   94      Recent Developments in Radiation Biology,   108      Recent Developments in Radiation Dosimetry and Radiation Dose and Risk Assessment,   114      Conclusion   121

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Assessment of the Scientific Information for the Radiation Exposure Screening and Education Program 5   EXPANDING RECA ELIGIBILITY: SCIENTIFIC ISSUES   122      Probability of Causation,   125      Tools for Determining PC/AS,   131      Use of PC/AS in Adjudication,   136      Application of PC/AS for Fallout from Atmospheric Weapons Testing,   138      Concerns with Using PC/AS in Compensation Programs,   139      Conclusion,   141      Annex,   143 6   EXPANDING RECA ELIGIBILITY: IMPLEMENTATION   148      Probability of Causation/Assigned Share,   148      Exposure to Fallout Radiation,   151      Implementation and Anticipated Impact of the Recommendation To Expand the Scope of RECA to Additional Geographic Areas,   164      Uranium Miners, Millers, and Ore Transporters in Other Geographic Areas,   168      Conclusion,   169 7   DISEASES, POPULATIONS, AND OTHER ISSUES OF PUBLIC CONCERN   172      Malignant Diseases,   173      Nonmalignant Diseases,   188      Psychologic Consequences of Radiologic Threats,   196      Additional Populations Occupationally at Risk for Radiation Exposure,   198      Additional Populations Environmentally at Risk for Radiation Exposure,   199      Defined Intervals for Which Compensation Is Granted,   202      Groups at Risk of Exposure Outside RECA’s Time-Since-Exposure Intervals,   203      Other Issues of Public Concern Regarding Eligibility for Compensation,   203 8   ETHICAL FRAMEWORK   205      The Ethics of a Compensation Program: Rectificatory and Distributive Justice,   206      The Ethics of Medical and Compensational Screening   214      Conclusion,   218

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Assessment of the Scientific Information for the Radiation Exposure Screening and Education Program 9   MEDICAL SCREENING   219      Historical Context of Screening in RESEP,   219      The Nature of Screening,   221      Principles of Screening,   224      Contemporary Screening Protocols,   227      Epidemiologic, Statistical, and Clinical Issues of Screening Tests,   231      Future Research,   252      Health-Care Issues Beyond Screening,   253      Conclusion,   256 10   SCREENING FOR COMPENSATION   257      Compensational Screening Issues: The Core Concern for RECA and RESEP,   258      Future Research,   270      Health-Care Issues Beyond Screening,   271      Conclusion,   273 11   EDUCATION AND OUTREACH   274      Characteristics of the Radiation Exposure Screening and Education Program,   275      Core Issues for RESEP,   289      Discussion and Recommendations,   292      Educational Program Planning and Implementation,   303      Conclusion,   308     REFERENCES   309     APPENDIXES         A   INVITED SPEAKERS AND PUBLIC COMMENT   333      Invited Speakers,   333      Statements from Members of the Public,   334     B   A COMPARISON OF THE RISK OF SKIN CANCER WITH THE RISK OF LUNG CANCER FROM EXPOSURE TO RADON DECAY PRODUCTS IN UNDERGROUND MINES   353      References,   357

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Assessment of the Scientific Information for the Radiation Exposure Screening and Education Program     C   RADIOACTIVITY IN GUAM AFTER NUCLEAR-WEAPONS TESTING IN THE PACIFIC RADIOACTIVE FALLOUT IN GUAM   359      Radioactive Fallout in Guam,   359      Cancer Incidence,   363      Ship Decontamination in Guam,   363      Summary,   365      References,   365     D   THE OPTIMAL CRITERION FOR POSITIVITY IN SCREENING   367      An Example,   369     E   SELECTED CANCER-SCREENING RECOMMENDATIONS   371      Introduction,   371      USPSTF Grades for Quality of Evidence,   372      USPSTF Grades for Strength of Recommendations,   372      Canadian TF Grades for Quality of Published Evidence,   373      Canadian TF Grades for Recommendations,   373     Appendix E-1: Screening Recommendations for Specific Cancers,   374     Appendix E-2: USPSTF Grade A and Grade B Screening Recommendations for Adults,   386      References,   386     GLOSSARY   387     LIST OF ABBREVIATIONS   405     COMMITTEE AND STAFF BIOGRAPHIES   408