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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Review of Report and Approach to Evaluating Long-Term Health Effects in Army Test Subjects: Final Report. Washington, DC: The National Academies Press. doi: 10.17226/25065.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Review of Report and Approach to Evaluating Long-Term Health Effects in Army Test Subjects: Final Report. Washington, DC: The National Academies Press. doi: 10.17226/25065.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Review of Report and Approach to Evaluating Long-Term Health Effects in Army Test Subjects: Final Report. Washington, DC: The National Academies Press. doi: 10.17226/25065.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Review of Report and Approach to Evaluating Long-Term Health Effects in Army Test Subjects: Final Report. Washington, DC: The National Academies Press. doi: 10.17226/25065.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Review of Report and Approach to Evaluating Long-Term Health Effects in Army Test Subjects: Final Report. Washington, DC: The National Academies Press. doi: 10.17226/25065.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Review of Report and Approach to Evaluating Long-Term Health Effects in Army Test Subjects: Final Report. Washington, DC: The National Academies Press. doi: 10.17226/25065.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Review of Report and Approach to Evaluating Long-Term Health Effects in Army Test Subjects: Final Report. Washington, DC: The National Academies Press. doi: 10.17226/25065.
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Page viii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Review of Report and Approach to Evaluating Long-Term Health Effects in Army Test Subjects: Final Report. Washington, DC: The National Academies Press. doi: 10.17226/25065.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Review of Report and Approach to Evaluating Long-Term Health Effects in Army Test Subjects: Final Report. Washington, DC: The National Academies Press. doi: 10.17226/25065.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Review of Report and Approach to Evaluating Long-Term Health Effects in Army Test Subjects: Final Report. Washington, DC: The National Academies Press. doi: 10.17226/25065.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Review of Report and Approach to Evaluating Long-Term Health Effects in Army Test Subjects: Final Report. Washington, DC: The National Academies Press. doi: 10.17226/25065.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Review of Report and Approach to Evaluating Long-Term Health Effects in Army Test Subjects: Final Report. Washington, DC: The National Academies Press. doi: 10.17226/25065.
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PREPUBLICATION COPY Review of Report and Approach to Evaluating Long-Term Health Effects in Army Test Subjects Final Report ADVANCE COPY NOT FOR PUBLIC RELEASE BEFORE Wednesday, April 25, 2018 1 p.m. EST This prepublication version has been provided to the public to facilitate timely access to the committee’s findings. Although the substance of the report is final, editorial changes will be made throughout the text, and citations will be checked prior to publication.

PREPUBLICATION COPY Review of Report and Approach to Evaluating Long-Term Health Effects in Army Test Subjects Final Report Committee to Review Report on Long-Term Health Effects on Army Test Subjects Board on Environmental Studies and Toxicology Division on Earth and Life Studies A Consensus Study Report of

THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001 This activity was supported by Contract W81K04-16-D-0036, Task 0002 between the National Academy of Sciences and the Department of Defense. Any opinions, findings, conclusions, or recommendations ex- pressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project. Digital Object Identifier: https://doi.org/10.17226/25065 Additional copies of this publication are available for sale from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http://www.nap.edu. Copyright 2018 by the National Academy of Sciences. All rights reserved. Printed in the United States of America Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2018. Review of Report and Approach to Evaluating Long-Term Health Effects in Army Test Subjects: Final Report. Washington, DC: The National Academies Press. doi: https://doi.org/10.17226/25065. ii Prepublication Copy

The National Academy of Sciences was established in 1863 by an Act of Congress, signed by President Lincoln, as a private, nongovernmental institution to advise the nation on issues related to science and technology. Members are elected by their peers for outstanding contributions to research. Dr. Marcia McNutt is president. The National Academy of Engineering was established in 1964 under the charter of the National Academy of Sciences to bring the practices of engineering to advising the nation. Mem- bers are elected by their peers for extraordinary contributions to engineering. Dr. C. D. Mote, Jr., is president. The National Academy of Medicine (formerly the Institute of Medicine) was established in 1970 under the charter of the National Academy of Sciences to advise the nation on medical and health issues. Members are elected by their peers for distinguished contributions to medicine and health. Dr. Victor J. Dzau is president. The three Academies work together as the National Academies of Sciences, Engineering, and Medicine to provide independent, objective analysis and advice to the nation and conduct other activities to solve complex problems and inform public policy decisions. The National Academies also encourage education and research, recognize outstanding contributions to knowledge, and increase public understanding in matters of science, engineering, and medicine. Learn more about the National Academies of Sciences, Engineering, and Medicine at www. nationalacademies.org. Prepublication Copy iii

Consensus Study Reports published by the National Academies of Sciences, Engineering, and Medicine document the evidence-based consensus on the study’s statement of task by an authoring committee of experts. Reports typically include findings, conclusions, and recommendations based on information gathered by the committee and the committee’s deliberations. Each report has been subjected to a rigorous and independent peer-review process and it represents the position of the National Academies on the statement of task. Proceedings published by the National Academies of Sciences, Engineering, and Medicine chronicle the presentations and discussions at a workshop, symposium, or other event convened by the National Academies. The statements and opinions contained in proceedings are those of the participants and are not endorsed by other participants, the planning committee, or the National Academies. For information about other products and activities of the National Academies, please visit www.nationalacademies.org/about/whatwedo. iv Prepublication Copy

COMMITTEE TO REVIEW REPORT ON LONG-TERM HEALTH EFFECTS ON ARMY TEST SUBJECTS Members IVAN RUSYN (Chair), Texas A&M University, College Station ERIN M. BELL, University of Albany, NY GERRY R. BOSS, University of California, San Diego JAMES E. CLEAVER, University of California, San Francisco PAMELA J. LEIN, University of California, Davis CATHERINE A. MCCARTY, University of Minnesota, Duluth NU-MAY RUBY REED, California Environmental Protection Agency (retired), Davis KENNETH R. STILL, Portland State University, Portland, OR VASILIS VASILIOU, Yale University, New Haven, CT Staff SUSAN N.J. MARTEL, Senior Program Officer TAMARA DAWSON, Program Associate Sponsor U.S. ARMY Prepublication Copy v

BOARD ON ENVIRONMENTAL STUDIES AND TOXICOLOGY Members WILLIAM H. FARLAND (Chair), Colorado State University, Fort Collins, CO LESA AYLWARD, Summit Toxicology, LLP, Falls Church, VA RICHARD A. BECKER, American Chemistry Council, Washington, DC E. WILLIAM COLGLAZIER, AAAS, Washington, DC DOMINIC M. DITORO, University of Delaware, Newark, DE DAVID C. DORMAN, North Carolina State University, Raleigh, NC ANNE FAIRBROTHER, Exponent, Inc., Philomath, OR GEORGE GRAY, The George Washington University, Washington, DC STEVEN P. HAMBURG, Environmental Defense Fund, New York, NY ROBERT A. HIATT, University of California, San Francisco, CA R. JEFFREY LEWIS, ExxonMobil Biomedical Sciences, Inc., Annandale, NJ H. SCOTT MATTHEWS, Carnegie Mellon University, Pittsburgh, PA ROBERT PERCIASEPE, Center for Climate and Energy Solutions, Arlington, VA R. CRAIG POSTLEWAITE, Department of Defense, Burke, VA REZA J. RASOULPOUR, Dow AgroSciences, Indianapolis, IN MARK A. RATNER, Northwestern University, Evanston, IL JOAN B. ROSE, Michigan State University, East Lansing, MI GINA M. SOLOMON, University of California, San Francisco, CA ROBERT M. SUSSMAN, Sussman and Associates, Washington, DC DEBORAH L. SWACKHAMER, University of Minnesota, St. Paul, MN PETER S. THORNE, University of Iowa, Iowa City, IA Staff TERESA A. FRYBERGER, Director ELLEN K. MANTUS, Scholar and Director of Risk Assessment RAYMOND A. WASSEL, Scholar and Director of Environmental Studies SUSAN N.J. MARTEL, Senior Program Officer for Toxicology ELIZABETH BOYLE, Program Officer TAMARA DAWSON, Program Associate BERNIDEAN WILLIAMS-SMITH, Financial Associate SUZANNE THILENIUS, Administrative Coordinator JESSICA WOLFMAN, Senior Program Assistant vi Prepublication Copy

Acknowledgments This Consensus Study Report was reviewed in draft form by individuals chosen for their diverse per- spectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the National Academies of Sciences, Engineering, and Medicine in making each published report as sound as possible and to ensure that it meets the institutional standards for quality, 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 individuals for their review of this report: Edward C. Bishop, HDR, Inc. (retired) David C. Dorman, North Carolina State University David R. Franz, Independent Consultant Philip J. Landrigan, Icahn School of Medicine at Mount Sinai Joel E. Michalek, University of Texas Health Science Center Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations of this report nor did they see the final draft before its release. The review of this report was overseen by David Eaton, University of Washington, and Martin Philbert, University of Michigan. They were responsible for making certain that an independent examination of this report was carried out in accordance with the standards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the authoring committee and the National Academies. The committee gratefully acknowledges the following individuals for their presentations to the com- mittee during its open session: Coleen Baird, U.S. Army Public Health Center; Weihsueh Chiu, Texas A&M University; Jonathan Samet, Colorado School of Public Health; and Rick Weidman, Vietnam Veterans of America. The committee also thanks Kathleen Stratton and Roberta Wedge of the Health and Medicine Division (HMD) of the National Academies for their assistance in providing background on the methods HMD has used in past projects to evaluate the adverse effects of vaccines and to evaluate potential health hazards to veterans of the Vietnam and Gulf Wars. Prepublication Copy vii

Contents SUMMARY ......................................................................................................................................................... 1 1 INTRODUCTION........................................................................................................................................ 6 The Committee’s Task and Approach, 6 Organization of the Report, 7 References, 7 2 EVALUATION OF THE REPORT ........................................................................................................... 8 Performance Work Statement, 8 Best Practices in Hazard Identification, 10 Examples of Missed Studies and Health Effects, 11 Findings and Recommendations, 13 References, 14 3 EVALUATION OF THE ARMY’S CAUSATION METHODOLOGY ............................................... 18 Review and Adjudication Process, 18 Causation Methodology, 18 Documentation, 20 Review of the IOM Recommended Approaches to Causality in the Context of Making Determinations About Providing Medical Care to Former Test Subjects, 20 Findings and Recommendations, 23 References, 24 4 STRATEGY FOR EVALUATING POTENTIAL LONG-TERM HEALTH EFFECTS IN ARMY TEST SUBJECTS ................................................................................................................... 26 Step 1: Agent Prioritization, 26 Step 2: Problem Formulation, 27 Step 3: Literature Search and Screening, 29 Step 4: Data Analysis and Evidence Synthesis, 30 Step 5: Evidence Integration, 30 Step 6: Drawing Hazard Identification Conclusions, 30 References, 30 APPENDIXES A BIOGRAPHICAL INFORMATION ON THE MEMBERS OF THE COMMITTEE TO REVIEW REPORT ON LONG-TERM HEALTH EFFECTS ON ARMY TEST SUBJECTS ............................................................................................... 32 B PUBLIC AGENDA FOR FIRST COMMITTEE MEETING ............................................................... 35 C DEPARTMENT OF THE ARMY MEMORANDUM OF INSTRUCTION, BENEFITS APPLICATION PANEL REVIEW AND ADJUDICATION OF APPLICATIONS FOR MEDICAL CARE ............................................................................................. 36 Prepublication Copy ix

Contents FIGURES AND TABLES FIGURES S-1 Proposed steps of a strategy to evaluate and categorize potential long-term health effects of biological and chemical agents, drugs, medications, and substances, 4 S-2 Proposed steps of a strategy to evaluate and categorize potential long-term health effects of biological and chemical agents, drugs, medications, and substances, 5 3-1 Process of reviewing epidemiological and mechanistic evidence in the IOM Vaccine Approach, 23 4-1 Proposed steps of a strategy to evaluate and categorize potential long-term health effects of biological and chemical agents, drugs, medications, and substances, 27 4-2 Proposed steps of a strategy to evaluate and categorize potential long-term health effects of biological and chemical agents, drugs, medications, and substances, 28 TABLES 2-1 Examples of References Missing from the Report, 12 2-2 Health Effects Not Evaluated in the Report, 13 x Prepublication Copy

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Between 1942 and 1975, the U.S. Army conducted tests on human subjects to study the effects of a variety of agents, including chemical warfare agents, biological agents, medications, vaccines, and other substances. The tests investigated the immediate or short-term health effects from acute exposure to understand vulnerabilities to attack. Whether the exposures could have resulted in long-term health consequences to the test subjects has been assessed periodically, and the Army is required to notify subjects of information relating to potential health effects associated with exposure to the test agents. Most recently, a 2016 court injunction directed the Army to provide test subjects with new information about potential long-term health effects associated with their exposures, and to provide medical care if an injury or illness could be attributed to their participation in an Army chemical or biological testing program. In support of the first requirement, the Army contracted a report, Assessment of Potential Long-Term Health Effects on Army Human Test Subjects of Relevant Biological and Chemical Agents, Drugs, Medications and Substances: Literature Review and Analysis (the Report), to determine whether new information published since 2006 should be provided to the veterans.

At the request of the Army, the National Academies of Sciences, Engineering, and Medicine formed an ad hoc committee that was tasked with conducting an independent review of the Report. The committee assessed whether the Report appropriately identified potential long-term health effects that could have resulted from test exposures using an adequate weight-of-evidence approach. The general approach for evaluating agent- and outcome-specific associations as outlined in the Army Memorandum was also reviewed. An interim report of its overarching findings and their supporting evidence was prepared in February 2018. This final report provides additional detail about the basis of the committee’s findings and recommendations. No new findings or recommendations have been added to this report.

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