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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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