Review of ATSDR’s Great Lakes Report Drafts (Letter Report)

Committee to Review ATSDR's Great Lakes Reports

Board on Population Health and Public Health Practice

INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

Washington, D.C.
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Review of ATSDR’s Great Lakes Report Drafts (Letter Report) Committee to Review ATSDR's Great Lakes Reports Board on Population Health and Public Health Practice

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THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW 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 200-2005-13434, TO #11 between the National Academy of Sciences and Department of Health and Human Services. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project. 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. For more information about the Institute of Medicine, visit the IOM home page at www.iom.edu. Copyright 2008 by the National Academy of Sciences. All rights reserved. Printed in the United States of America The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin. IOM (Institute of Medicine). 2008. Review of ATSDR’s Great Lakes Report Drafts (Letter Report). Washington, DC: The National Academies Press.

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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. Charles M. Vest 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. Charles M. Vest are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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COMMITTEE TO REVIEW ATSDR’S GREAT LAKES REPORTS ROBERT WALLACE (Chair), Irene Ensminger Stecher Professor of Epidemiology and Internal Medicine, Department of Epidemiology, College of Public Health, University of Iowa, Iowa City, Iowa JOHN C. BESLEY, Assistant Professor, Science and Risk Communication, School of Journalism and Mass Communications, University of South Carolina, Columbia, South Carolina EDMUND A.C. CROUCH, Senior Scientist, Cambridge Environmental Inc., Cambridge, Massachusetts FRANCESCA DOMINICI, Professor, Department of Biostatistics, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland MARION F. EHRICH, Professor, Biomedical Sciences and Pathobiology, Virginia–Maryland Regional College of Veterinary Medicine, Virginia Tech, Blacksburg, Virginia S. KATHARINE HAMMOND, Professor and Chair, Environmental Health Sciences Division, School of Public Health, University of California, Berkeley, California DAVID A. KALMAN, Professor and Chair, Environmental and Occupational Health Sciences, University of Washington, Seattle, Washington SUSAN A. KORRICK, Assistant Professor of Medicine, Channing Laboratory, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts MARIE C. MCCORMICK, Sumner and Esther Feldberg Professor of Maternal and Child Health, Department of Society, Human Development, and Health, Harvard School of Public Health, Boston, Massachusetts PATRICIA A. NOLAN, Adjunct Associate Professor of Community Health, Department of Community Health, Warren Alpert Medical School, Brown University, Providence, Rhode Island MARA SEELEY, Senior Toxicologist, Gradient Corporation, Cambridge, Massachusetts v

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STAFF Michelle C. Catlin, Study Director Naoko Ishibe, Program Officer Jennifer Saunders, Senior Program Associate Rose Marie Martinez, Director, Board on Population Health and Public Health Practice Joseph Goodman, Senior Program Assistant Norman Grossblatt, Senior Editor vi

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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 purpose of the independent review is to provide candid and critical comments that will assist the institution in making its 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 thank the following for their review of this report: John C. Bailar III, The University of Chicago, Professor Emeritus Linda D. Cowan, College of Public Health, University of Oklahoma Tom Gasiewicz, Department of Environmental Medicine, University of Rochester Medical Center Lynne Haber, Toxicology Excellence for Risk Assessment Shelley A. Hearne, Health and Human Services Program, The Pew Charitable Trusts Barbara A. Knuth, College of Agriculture and Life Sciences, Cornell University Robin Puett, South Carolina Cancer Prevention and Control Program, University of South Carolina Joshua Sharfstein, Baltimore City Health Department, Baltimore, Maryland 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 Gilbert S. Omenn, Center for Computational Medicine and Biology, University of Michigan Medical School and Jonathan M. Samet, Bloomberg School of Public Health, Johns Hopkins University. Appointed by the National Research Council and the Institute of Medicine, they were responsible for making certain that an independent examination of the 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 author committee and the institution. vii

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CONTENTS COVER LETTER TO DR. JAMES STEPHENS......................................................................1 REVIEW OF ATSDR’S GREAT LAKES REPORT DRAFTS (LETTER REPORT) ............7 Organization of This Letter Report .......................................................................................7 Background on ATSDR Drafts Evaluated ............................................................................8 Overarching Comments on the Draft Reports.......................................................................9 Purpose of the Report Drafts ............................................................................................11 Scope of Project and Literature Review ...........................................................................12 Appropriateness of Datasets, Scientific Quality of Data Analysis and Presentation, and Conclusions ....................................................................................................................13 Contaminant Data .............................................................................................................13 Demographic Data ............................................................................................................17 Health Data .......................................................................................................................18 Data Analysis....................................................................................................................20 Presentation of the Information ........................................................................................21 Conclusions of Report Drafts ...........................................................................................22 Responsiveness to Reviewers’ Comments on 2004 Report Draft ......................................24 Validity of Directors’ Offices’ Concerns Regarding 2007 Report Draft...........................25 Responsiveness to Reviewers’ Comments on 2007 Report Draft ......................................26 Scientific Soundness of 2008 Report Draft.........................................................................26 Suggested Improvements and Other Committee Concerns ................................................27 Conclusions .........................................................................................................................28 References ...........................................................................................................................30 APPENDIX A MAPS OF GREAT LAKES AREAS OF CONCERN ...................................33 APPENDIX B LETTER FROM IJC ......................................................................................37 APPENDIX C MATERIALS RECEIVED FROM ATSDR ...................................................39 APPENDIX D ABBREVIATIONS.........................................................................................40 Boxes and Figures BOX 1 Statement of Task ..........................................................................................................7 BOX 2 Timeline of Events ......................................................................................................10 BOX 3 Example of an Indirect Effect......................................................................................12 BOX 4 Example of the Addition or Removal of Hazardous-Waste Sites Without Following the Criteria ......................................................................................................13 BOX 5 Example of Conclusion That Was Not Justified by Report Contents .........................24 BOX 6 Example of Recommendation That Was Not Justified by Report Contents ...............24 FIGURE A-1 Great Lakes Areas of Concern ..........................................................................33 FIGURE A-2 Ashtabula River Area of Concern, Ohio ...........................................................34 FIGURE A-3 Clinton River Area of Concern, Michigan ........................................................35 viii