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Suggested Citation:"Front Matter." National Academy of Sciences. 2000. Review of the Hanford Thyroid Disease Study Draft Final Report. Washington, DC: The National Academies Press. doi: 10.17226/9738.
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Suggested Citation:"Front Matter." National Academy of Sciences. 2000. Review of the Hanford Thyroid Disease Study Draft Final Report. Washington, DC: The National Academies Press. doi: 10.17226/9738.
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Suggested Citation:"Front Matter." National Academy of Sciences. 2000. Review of the Hanford Thyroid Disease Study Draft Final Report. Washington, DC: The National Academies Press. doi: 10.17226/9738.
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Suggested Citation:"Front Matter." National Academy of Sciences. 2000. Review of the Hanford Thyroid Disease Study Draft Final Report. Washington, DC: The National Academies Press. doi: 10.17226/9738.
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Suggested Citation:"Front Matter." National Academy of Sciences. 2000. Review of the Hanford Thyroid Disease Study Draft Final Report. Washington, DC: The National Academies Press. doi: 10.17226/9738.
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Suggested Citation:"Front Matter." National Academy of Sciences. 2000. Review of the Hanford Thyroid Disease Study Draft Final Report. Washington, DC: The National Academies Press. doi: 10.17226/9738.
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Suggested Citation:"Front Matter." National Academy of Sciences. 2000. Review of the Hanford Thyroid Disease Study Draft Final Report. Washington, DC: The National Academies Press. doi: 10.17226/9738.
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Suggested Citation:"Front Matter." National Academy of Sciences. 2000. Review of the Hanford Thyroid Disease Study Draft Final Report. Washington, DC: The National Academies Press. doi: 10.17226/9738.
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Suggested Citation:"Front Matter." National Academy of Sciences. 2000. Review of the Hanford Thyroid Disease Study Draft Final Report. Washington, DC: The National Academies Press. doi: 10.17226/9738.
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Review of the Did .1 to Committee on an Assessment of Centers for Disease Control and Prevention Radiation Studies from DOE Contractor Sites: Subcommittee to Review the Hanford Thyroid Disease Study Final Results and Report Board on Radiation Effects Research Commission on Life Sciences National Academy of Sciences NATIONAL ACADEMY PRESS Washington, DC 2000

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 0-309-06883-5 A limited number of copies of this report are available from 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. Printed in the United States of America

.. ~ : ...; National Acaclemy of Sciences National Acaclemy of Engineering Institute of Meclicine National Research Council : :''' :.#-: ......... 0 . ~ (2-it. ~--8'%,j2 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 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. William A. Wulf are chairman and vice chairman, respectively, of the National Research Council. . . . 111

COMMITTEE ON AN ASSESSMENT OF CENTERS FOR DISEASE CONTROL AND PREVENTION RADIATION STUDIES FROM DOE CONTRACTOR SITES: SUBCOMMITTEE TO REVIEW T1IE HANFORD THYROID DISEASE STUDY FINAL RESULTS AND REPORT ROY E. SHORE (Chair), New York University School of Medicine, New York, NY ANDRE' BOUVILLE, National Cancer Institute, Bethesda, MD BRUCE B. BOECKER, Lovelace Respiratory Research Institute, Albuquerque, NM A. BERTRAND BRILL, Vanderbilt University Medical School, Nashville, TN PATRICIA A.H. BUFFLER, University of California, Berkeley, CA SHARON M. FRIEDMAN, Lehigh University, Bethlehem, PA SUSAN E. LEDERER, Yale University School of Medicine, New Haven, CT CARL M. MANSFIELD, University of Maryland Medical Systems, Baltimore, MD DONALD E. MYERS, University of Arizona, Tucson, AZ DANIEL O. STRAM, University of Southern California, Los Angeles, CA ROBERT G. THOMAS, Folsom, CA CONSULTANTS HAROLD BECK, Environmental Measurements Laboratory, New York, NY, Retired MAUREEN HATCH, Mt. Sinai School of Medicine, New York, NY ARTHUR SCHNEIDER, University of Illinois College of Medicine, Chicago, IL ERNEST MAZZAFERRI, Ohio State University, Columbus, OH, Retired CLS ADVISER BARABARA S. HULKA, University of North Carolina at Chapel Hill, NC NATIONAL RESEARCH COUNCIL STAFF STEVEN L. SIMON, Study Director BRIDGET R. EDMONDS, Project Assistant DORIS E. TAYLOR, Staff Assistant SPONSOR'S PROJECT OFFICER JAMES SMITH, Centers for Disease Control and Prevention EDITOR NOR1\lAN GROSSBLATT . 1V

BOARD ON RADIATION EFFECTS RESEARCH R.J. MICHAEL FRY (Chair), Oak Ridge National Laboratory, Oak Ridge, TN S. JA1VIES ADELSTEIN i, Harvard Medical School, Boston, MA VALERIE BERAL, University of Oxford, United Kingdom SARAH G. DONALDSON:, Stanford University Medical Center, Stanford. CA* EDWARD R. EPP, Harvard University, Boston, MA HELEN H. EVANS, Case Western Reserve University, Cleveland, OH LYNN W. JELINSKI, Louisiana State University, Baton Rouge, LA WILLIA1\I F. MORGAN, The University of Maryland, Baltimore, MD FRANKLYN G. PRENDERGAST, Mayo Clinic Cancer Center, Rochester, MN* WILLIAM J. SCHOLL, The University of Texas Health Science Center, Houston, TX DANIEL O. STRAM, University of Southern California, Los Angeles, CA NATIONAL RESEARCH COUNCIL STAFF EVAN B. DOUPLE, Director, Board on Radiation Effects Research RICK JOSTES, Senior Program Officer STEVEN L. SIMON, Senior Program Officer ISAF AL-NABULSI, Visiting Scientist CATHERINE S. BERKLEY, Administrative Associate DORIS E. TAYLOR, Staff Assistant BRIDGET R. EDMONDS, Project Assistant ERIC W. TRUETT, Project Assistant Member of IOM *New members effective 7/1/99 v

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, NJ JAMES E. CLEAVER, UCSF Cancer Center, San Francisco, CA DAVID S. EISENBERG, University of California, Los Angeles, CA JOHN L. EMMERSON, Portland, OR NEAL L. FIRST, University of Wisconsin, Madison, WI DAVID J. GALAS, Keck Graduate Institute of Applied Life Science, Claremont, CA DAVID V. GOEDDEL, Tularik, Inc., South San Francisco, CA ARTURO GOMEZ-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 Institute, Boston, MA DONALD R. MATTISON, March of Dimes, White Plains, NY ELLIOT M. MEYEROWITZ, California Institute 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, Stoney Brook, NY CHARLES F. STEVENS, The Salk Institute for Biological Studies, LaJolla, CA SHIRLEY M. TILGHMAN, Princeton University, Princeton, NJ RAY1\IOND L. WHITE, University of Utah, School of Medicine, Salt Lake City, UT NATIONAL RESEARCH COUNCIL STAFF WARREN R. MUIR, Executive Director V1

ACKNOWLEDGEMENTS During the course of the committee's deliberations, several individuals provided information to the committee. Appreciation for these contributions is extended to the following: Harold Beck, Environmental Measurements Laboratory, New York, NY, Retired Maureen Hatch, Mt. Sinai School of Medicine, New York, NY Arthur Schneider, University of Illinois College of Medicine, Chicago, IL Ernest Mazzaferri, Ohio State University, Columbus, OH, Retired Owen Hoffman, Senes Oak Ridge, TN William Farris, Pacific Northwest National Laboratory, Richland, WA Trisha Pritikin, Berkeley, CA Keith Baverstock, World Health Organization, Helsinki, Finland Lynn Lyon, University of Utah, Salt Lake City, UT Charles Grossman, Legacy Good Samaritan Hospital, Portland, Oregon, and Northwest Radiation Health Alliance Robert Schenter, Pacific Northwest National Laboratory, Richland, WA James Ruttenber, University of Colorado School of Medicine, Denver, CO Tim Connor, North West Environmental Education Foundation, Spokane, WA James Thomas, Short, Cressman and Burgess, Seattle, WA Edward Liebow, Environmental Health and Social Policy Center, Seattle, WA Larry Jecha, Benton-Franklin Health Depa~ent, Richland, WA Judith Jurgi, Hanford Downwinders Coalition, Seattle, WA Louise Kaplan, Pacific Lutheran University, Tacoma, WA Bea Kelliegh, Hanford Health Information Network, Seattle, WA Laura Chenet-Leonard, Oregon Health Division, Portland, OR Elke Shaw-Tullock, Idaho Division of Health, Boise, ID Lynn Stembridge, Hanford Education Action League, Spokane, WA Kenneth Kopecky, Fred Hutchinson Cancer Research Center, Seattle, WA Scott Davis, Fred Hutchinson Cancer Research Center, Seattle, WA Karen Dorn-Steele, Spokane Spokesman-Review, Spokane, WA Annette Cary, Tri-Cities Herald, Spokane, WA 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 . . V11

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 Buonaccorsi, University of Massachusetts, Amherst, MA Darrell Fisher, Pacific Northwest National Laboratory, Richland, WA Robert Griffin, Marquette University, Milwaukee, WI David G. Hoel, Medical University of South Carolina, Charleston, SC Henry D. Royal, Mallinckrodt Institute of Radiology, St. Louis, MO Richard B. Setlow, Brookhaven National Laboratory, Upton, L.I., NY Leonard A. Stefanski, North Carolina State University, Raleigh, NC Steve Wing, University of North Carolina at Chapel Hill, NC While the individuals listed above have provided constrictive comments and suggestions, it must be emphasized that responsibility for the final content of this report rests entirely with the authoring committee and the institution. The committee is very appreciative for the expertise, dedication, and hard work of the study director, Steven L. Simon. The attention to administrative details by Doris E. Taylor and Bridget R. Edmonds from the Research Council's Board on Radiation Effects Research is also appreciated. Sincere appreciation is also extended to Norman Grossblatt, who edited the report. . . . vail

CONTENTS Public Summary Executive Summary 17 1. Introduction 40 2. Overview of the HTDS Draft Final Report and Organization of the Committee's Report 42 3. Evaluation of Epidemiologic and Clinical Methods 49 4. Evaluation of Dosimetric Methods and Results 61 5. Evaluation of Statistical Data Analysis 86 6. Statistical Power and Interpretation of the Study Comparison with Other Studies - 8. Communication of Study Results........................................................... 9. Summary of Responses to CDC's Questions .. 10. References....................................................... Appendixes A Subcommittee Activities ......................... B Responses to Selected Comments by the Public Estimated Thyroid Doses From "Global" Weapons Test Fallout In ,99 ... 111 ...114 .137 ............. 156 .163 .168 Areas Downwind From Hanford 176 D Equation Relating to the Effect of Error in Assessing Childhood MiLk Consumption 198 Glossary 200 Information on Committee Members 212 1X

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In 1986, officials of the US Department of Energy revealed that the Hanford Atomic Products Operations in Richland, Washington, had been releasing radioactive material, in particular iodine-131, into the environment over a period of years. This information, which confirmed the suspicions of some people in the Pacific Northwest about what they called the Hanford Reservation or just Hanford, created quite a stir. Both the US Congress and citizens of the Northwest became keenly interested in knowing whether these radiation releases had caused human health effects. They were particularly concerned about whether Hanford releases of iodine-131 had led to an increase in thyroid disease among the population of the area.

In 1988, Congress ordered a study of the human health effects of exposure to the iodine-131 released from Hanford. Funded by the Centers for Disease Control and Prevention (CDC), the study was carried out by the Seattle-based Fred Hutchinson Cancer Research Center over the last decade. The study examined estimate of exposure of the thyroid and rates of thyroid disease because iodine-131 concentrates in the thyroid and that organ would be the best indicator of radiation damage in the population. The Centers for Disease Control and Prevention (CDC) asked the National Academy of Sciences-National Research Council (NAS-NRC) to give an independent appraisal of the study methodology, results, and interpretation and of the communication of the study results to the public.

Review of the Hanford Thyroid Disease Study Draft Final Report constitutes the response of the NRC subcommittee to that request. To respond to the charge, the NRC subcommittee felt that it needed to go beyond the specific questions addressed to it by CDC and develop a broad understanding and critique of the HTDS and the Draft Final Report. As part of those activities, the subcommittee solicited comments from outside experts and members of the public primarily in a public meeting held in Spokane, Washington, in June 1999, where 14 scientists and members of the public made formal presentations to the subcommittee about various aspects of the Draft Final Report. Other members of the public also spoke during four open-comment sessions at the meeting. In addition, efforts were made to evaluate all information materials prepared for the public and additional CDC communication plans. Information was gathered through interviews with journalists, members of concerned citizen groups in the Hanford region, members of the CDC scientific and media staff in Atlanta, and the HTDS investigators.

In this summary, the main points follow the structure of our report and are presented under several headings: epidemiologic and clinical methods and data collection, dosimetry, statistical analyses, statistical power and interpretation of the study, and communication of the study results to the public. We then provide a brief synopsis of our response to the questions raised by CDC.

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