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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services REVIEW OF THE WORKER AND PUBLIC HEALTH ACTIVITIES PROGRAM ADMINISTERED BY THE DEPARTMENT OF ENERGY AND THE DEPARTMENT OF HEALTH AND HUMAN SERVICES Committee to Review the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services Nuclear and Radiation Studies Board Board on Environmental Studies and Toxicology 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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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services 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 U.S. Department of Energy contract #DE-AM01-04PI45013. 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-10: 0-309-10338-X International Standard Book Number-13: 978-0-309-10338-1 Cover: Top left and top right photos courtesy of the U.S. Department of Energy Hanford site website. Middle left photo courtesy of the U.S. Department of Energy Oak Ridge office. Selection and use of these photos are not related to the findings and recommendations expressed in the report. Additional copies of this report are available from the National Academies Press, 500 Fifth Street, N.W., Lockbox285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu. Copyright 2006 by the National Academy of Sciences. All rights reserved. Printed in the United States of America
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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services 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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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services COMMITTEE TO REVIEW THE WORKER AND PUBLIC HEALTH ACTIVITIES PROGRAM ADMINISTERED BY THE DEPARTMENT OF ENERGY AND THE DEPARTMENT OF HEALTH AND HUMAN SERVICES EDWIN P. PRZYBYLOWICZ, Chair, Eastman Kodak Company (retired), Webster, NY EDWIN H. CLARK, II, Clean Sites Environmental Services, Inc., Washington, DC IRWIN FELLER, Penn State University (retired), State College, PA PENNY FENNER-CRISP, ILSI Risk Science Institute (retired), North Garden, VA R. WILLIAM FIELD, University of Iowa, Iowa City SHARON M. FRIEDMAN, Lehigh University, Bethlehem, PA HELEN A. GROGAN, Cascade Scientific, Inc., Bend, OR JACK MANDEL, Emory University, Atlanta, GA GLENN PAULSON, UMDNJ School of Public Health, New Brunswick, NJ ROSEMARY K. SOKAS, University of Illinois, Chicago DANIEL O. STRAM, University of Southern California, Los Angeles TONGZHANG ZHENG, Yale University School of Public Health, New Haven, CT Nuclear and Radiation Studies Board Liaison PAUL A. LOCKE, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD National Research Council Staff RICK JOSTES, Study Director EILEEN ABT, Study Director NAOKO ISHIBE, Program Officer JENNIFER SAUNDERS, Associate Program Officer TONI GREENLEAF, Financial and Administrative Associate COURTNEY GIBBS, Senior Program Assistant JAMES YATES, JR., Office Assistant
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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services NUCLEAR AND RADIATION STUDIES BOARD RICHARD A. MESERVE, Chair, Carnegie Institution, Washington, DC S. JAMES ADELSTEIN, Vice Chair, Harvard Medical School, Boston, MA HAROLD L. BECK, Department of Energy Environmental Laboratory (retired), New York City, NY JOEL S. BEDFORD, Colorado State University, Fort Collins ROBERT M. BERNERO, U.S. Nuclear Regulatory Commission (retired), Gaithersburg, MD SUE B. CLARK, Washington State University, Pullman ALLEN G. CROFF, Oak Ridge National Laboratory (retired), Oak Ridge, TN DAVID E. DANIEL, University of Texas at Dallas SARAH C. DARBY, Clinical Trial Service Unit (CTSU), Oxford, United Kingdom RODNEY C. EWING, University of Michigan, Ann Arbor ROGER L. HAGENGRUBER, University of New Mexico, Albuquerque DANIEL KREWSKI, University of Ottawa, Ontario, Canada KLAUS KÜHN, Technische Universität Clausthal, Clausthal-Zellerfeld, Germany SUSAN M. LANGHORST, Washington University, St. Louis, MO NIKOLAY P. LAVEROV, Russian Academy of Sciences, Moscow MILTON LEVENSON, Bechtel International (retired), Menlo Park, CA C. CLIFTON LING, Memorial Hospital, New York City, NY PAUL A. LOCKE, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD WARREN F. MILLER, Texas A&M University, Albuquerque, NM ANDREW M. SESSLER, E.O. Lawrence Berkeley National Laboratory, Berkeley, CA ATSUYUKI SUZUKI, Nuclear Safety Commission of Japan, Tokyo JOHN C. VILLFORTH, Food and Drug Law Institute (retired), Gaithersburg, MD PAUL L. ZIEMER, Purdue University (retired), West Lafayette, IN National Research Council Staff KEVIN D. CROWLEY, Senior Board Director EVAN B. DOUPLE, Scholar RICK JOSTES, Senior Program Officer MICAH D. LOWENTHAL, Senior Program Officer JOHN R. WILEY, Senior Program Officer
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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services NAOKO ISHIBE, Program Officer TONI GREENLEAF, Financial and Administrative Associate LAURA D. LLANOS, Financial and Administrative Associate COURTNEY GIBBS, Senior Program Assistant MARILI ULLOA, Senior Program Assistant JAMES YATES, JR., Office Assistant
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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services BOARD ON ENVIRONMENTAL STUDIES AND TOXICOLOGY Members JONATHAN M. SAMET, Chair, Johns Hopkins University, Baltimore, MD RAMÓN ALVAREZ, Environmental Defense, Austin, TX JOHN M. BALBUS, Environmental Defense, Washington, DC DALLAS BURTRAW, Resources for the Future, Washington, DC JAMES S. BUS, Dow Chemical Company, Midland, MI COSTEL D. DENSON, University of Delaware, Newark E. DONALD ELLIOTT, Willkie Farr & Gallagher LLP, Washington, DC MARY R. ENGLISH, University of Tennessee, Knoxville J. PAUL GILMAN, Oak Ridge Center for Advanced Studies, Oak Ridge, TN SHERRI W. GOODMAN, Center for Naval Analyses, Alexandria, VA JUDITH A. GRAHAM, American Chemistry Council, Arlington, VA WILLIAM P. HORN, Birch, Horton, Bittner and Cherot, Washington, DC JAMES H. JOHNSON, JR., Howard University, Washington, DC WILLIAM M. LEWIS, JR., University of Colorado, Boulder JUDITH L. MEYER, University of Georgia, Athens DENNIS D. MURPHY, University of Nevada, Reno PATRICK Y. O’BRIEN, ChevronTexaco Energy Technology Company, Richmond, CA DOROTHY E. PATTON (retired), Chicago, IL DANNY D. REIBLE, University of Texas, Austin JOSEPH V. RODRICKS, ENVIRON International Corporation, Arlington, VA ARMISTEAD G. RUSSELL, Georgia Institute of Technology, Atlanta ROBERT F. SAWYER, University of California, Berkeley LISA SPEER, Natural Resources Defense Council, New York, NY KIMBERLY M. THOMPSON, Massachusetts Institute of Technology, Cambridge MONICA G. TURNER, University of Wisconsin, Madison MARK J. UTELL, University of Rochester Medical Center, Rochester, NY CHRIS G. WHIPPLE, ENVIRON International Corporation, Emeryville, CA LAUREN ZEISE, California Environmental Protection Agency, Oakland Senior Staff JAMES J. REISA, Director DAVID J. POLICANSKY, Scholar RAYMOND A. WASSEL, Senior Program Officer for Environmental Sciences and Engineering KULBIR BAKSHI, Senior Program Officer for Toxicology
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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services EILEEN N. ABT, Senior Program Officer for Risk Analysis KARL E. GUSTAVSON, Senior Program Officer K. JOHN HOLMES, Senior Program Officer ELLEN K. MANTUS, Senior Program Officer SUSAN N.J. MARTEL, Senior Program Officer SUZANNE VAN DRUNICK, Senior Program Officer RUTH E. CROSSGROVE, Senior Editor
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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services Preface This committee was constituted in the Fall of 2005 at the request of the Department of Energy (DOE) to review the Worker and Public Health Program operated by the Department of Health and Human Services (HHS) at DOE nuclear facilities from 1990 to 2004. The program responsibilities were defined in three Memoranda of Understanding (MOUs) signed at the secretarial level between these departments in 1990, 1996 and 2000. The National Institute of Occupational Safety and Health which carried out a portion of this program, called it the Occupational Energy Research Program. Other HHS organizations that were involved in carrying out parts of this program during this period were the National Center for Environmental Health and the Agency for Toxic Substances and Disease Registry (beginning with the 1996 MOU). This program represented a change in the worker and public health programs at nuclear facilities that until 1990 had been operated by DOE and included contracts and grants directly managed by the department. Pressure from the public and Congress for a health program with a degree of independence from DOE led to the arrangement under the MOUs in which DOE provided the funding for agencies within HHS that carried out the health studies and some aspects of the communication program. In requesting this study DOE asked the committee to assess whether this program achieved the goals set out for it and to make recommendations on how to improve its effectiveness for the future. The committee report was to be completed within 16 months from the inception of the contract. The study was launched with the committee’s first meeting in November 2005 during which units involved in the program from both DOE and HHS provided briefings relevant to this committee’s task. At this meeting, the commit-
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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services tee formulated its approach to the study and identified specific questions and issues which were conveyed to DOE and HHS for response. The committee organized itself around three types of program activities: the technical activities, the public and worker communication activities, and the program governance and management. Using these broad areas of activity, the committee reviewed the HHS agencies’ research priorities, research project selection, usefulness of results, and dissemination of completed research. To evaluate the quality of the programs from the viewpoint of science and public policy the committee used a sampling strategy that reviewed selected studies from three DOE sites and, in some cases, multisite studies or products that were not site-specific. This approach allowed the committee to examine detail, when appropriate, while providing an overall assessment of the program and its achievements. The sampling was initially defined by focusing on program activities involving the Hanford, Oak Ridge, and Los Alamos sites. Activities at these sites were looked at in some detail although by no means comprehensively. It became apparent that a number of the activities spanned several sites and such activities were looked at across the appropriate sites. While this study did not comprehensively evaluate all of the individual studies within the program, it is the committee’s judgment that the subset of activities that were examined did provide a sample from which conclusions regarding the effectiveness of the program could be made. It was on the basis of the committee’s overview of these programs that recommendations for the future operation of such a program were made. While this study was nearing completion, the DOE Secretary announced a reorganization that could affect the health and safety programs within DOE. It was not clear to the committee what impact this reorganization, if carried out, will have on DOE’s Worker and Public Health Program. The committee was not tasked to comment on the DOE reorganization or the transfer of the Worker and Public Health Program within the agency’s structure.
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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services General Acknowledgments The committee was aided in the consideration of its charge not only by comments from the public but also by formal presentations by experts from a number of fields. The following presentations were made as part of the public portion of the meetings (in order of appearance): Presentations Steve Cary U.S. Department of Energy, Office of Environment, Safety and Health (DOE-EH) Lewis Wade, V, PhD National Institute for Occupational Safety and Health (NIOSH) Mary Schubauer-Berigan, PhD NIOSH Tom Sinks, PhD National Center for Environmental Health (NCEH)/ Agency for Toxic Substances and Disease Registry (ATSDR) William Cibulas, PhD ATSDR
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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services Charles W. Miller, PhD NCEH/Centers for Disease Control and Prevention Paul Ziemer, PhD Former Assistant Secretary for Environment, Safety, and Health David Michaels, PhD Former Assistant Secretary for Environment, Safety, and Health F. Owen Hoffman, PhD SENES Oak Ridge, Inc. Center for Risk Analysis We thank these presenters and all other members of the public who spoke on issues related to the Worker and Public Health Activities Program. The committee also wishes to thank the agencies involved in this program for supplying information in response to what must have seemed to them, an endless stream of questions and requests from the committee. From DOE, Steve Cary, Gerry Peterson and Marsha Lawn, and from HHS, Mary Schubauer-Berigan, who fielded not only many questions from the committee but who also prepared an excellent evidence package of information with supplements about the program that was a valuable resource for the committee to help initiate its assessment. The committee also thanks the National Research Council staff who supported the committee in an active and timely way throughout this study. Studies such as these are long on information and short on time. It is only through the extraordinary efforts of the NRC staff through Program Director Rick Jostes’ orchestration that this study was completed on time and budget. Special thanks to Eileen Abt for her contributions to the study and to Jen Saunders and Naoko Ishibe for their scientific and technical contributions to the report and to Courtney Gibbs for arranging the meetings and preparing the manuscript for publication. Finally, the chair wishes to thank the individual committee members who gave of their time and expertise in this service to their government. Studies such as this are accomplished under the charter of the National Academies whose role as “advisors to the government” is accomplished through the voluntary efforts of experts such as this committee. As chair of a number of study committees such as this, I am always impressed with the expertise and commitment that committee members bring to these study tasks. This committee was no exception and my thanks go to each of them for their service on this committee. EDWIN P. PRZYBYLOWICZ, Chair
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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services 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: Lynn R. Anspaugh, University of Utah School of Medicine, Henderson, NV Harold L. Beck, Department of Energy Environmental Laboratory (retired), New York City, NY Jack Cornett, Health Canada, Ottawa, Ontario Ethel S. Gilbert, National Cancer Institute, Rockville, MD Thomas Hinton, Savannah River Ecology Laboratory, Aiken, SC David G. Hoel, Medical University of South Carolina, Charleston Karl Kelsey, Harvard School of Public Health, Boston, MA Katherine E. Rowan, George Mason University, Fairfax, VA Susan Wiltshire, Independent Consultant, South Hamilton, 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
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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services review of this report was overseen by Frank E. Speizer, Harvard School of Public Health, and John C. Bailar III, Professor Emeritus, University of Chicago. 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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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services Contents EXECUTIVE SUMMARY 1 SUMMARY 5 Statement of Task, 6 Sampling Strategy, 6 Assessment of Program Management Issues: Strengthen the MOU to Utilize the Unique Strengths of DOE and HHS to Include the Following Elements, 7 Scientific Program Assessment: Focus and Extend Selected Scientific Studies, 11 Evaluation of Dissemination and Communication: Improve Dissemination and Communication of Results to Workers and the Public, 15 1 INTRODUCTION 19 Department of Energy’s Office of Environment, Safety and Health, 20 Worker and Public Health Activities Program, 21 NRC Committee to Review the Worker and Public Health Activities Program, 25 Annex 1A Budgetary Tables, 31 References, 33
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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services 2 SCIENTIFIC PROGRAM ASSESSMENT: NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH 36 Complexities and Limitations Involved in the Epidemiological Studies, 37 DOE Single-site Mortality Studies, 39 Multisite Epidemiological Studies, 41 Research Priorities, Scientific Merit of Research, Research Dissemination, and Benefits of Research to DOE, 51 Findings and Recommendations, 58 Annex 2A NIOSH Research Publications, 64 References, 90 3 SCIENTIFIC PROGRAM ASSESSMENT: AGENCY FOR TOXIC SUBSTANCES AND DISEASE REGISTRY 94 ATSDR Program Areas Relevant to the MOU, 95 Review of Selected Public Health Assessments at the Three Committee-Selected Sites, 95 Health Studies, 105 ATSDR Toxicology Profiles, 107 Other ATSDR Products, 108 Summary, 110 Findings and Recommendations, 110 Annex 3A CERCLA Directive Regarding Public Health Assessments, 111 Annex 3B ATSDR Description of Toxicological Profiles, 111 References, 112 4 SCIENTIFIC PROGRAM ASSESSMENT: DOSE RECONSTRUCTION PROJECTS SUPPORTED BY THE NATIONAL CENTER FOR ENVIRONMENTAL HEALTH 114 Hanford Environmental Dose Reconstruction Project, 121 Los Alamos Dose Reconstruction Project, 124 Contributions to DOE, 126 Summary, 126 Findings and Recommendations, 126 References, 127 5 EVALUATING THE DEPARTMENT OF HEALTH AND HUMAN SERVICES DISSEMINATION AND COMMUNICATION EFFORTS 130 Introduction, 130 Communicating About Radiation Risks, 131 Committee’s Approach to Evaluating the HHS Efforts, 136 Agency Communication Efforts, 137
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Review of the Worker and Public Health Activities Program Administered by the Department of Energy and the Department of Health and Human Services Agency Communication Efforts with Advisory Committees, 154 Discussion, 161 Findings and Recommendations, 167 Annex 5A The Hanford Community, 170 Annex 5B The Oak Ridge Community, 181 Annex 5C The Los Alamos Community, 189 References, 195 6 PROGRAM MANAGEMENT ASSESSMENT 200 Background, 200 Memoranda of Understanding, 202 Input from External Sources, 203 Discussion: Managing Interagency Research Programs, 210 The Data Problem, 216 Impact or Value of Research Program, 218 Findings and Recommendations, 222 Annex 6A Annex Tables, 226 References, 246 APPENDIXES A 1990 Memorandum of Understanding 249 B SPEERA Executive Summary 263 C Abbreviations, Acronyms, and Definitions 266 D Committee Biographies 272
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