Evaluation of the Health and Safety Risks of the New USAMRIID High-Containment Facilities at Fort Detrick, Maryland

Committee to Review the Health and Safety Risks of High-Biocontainment Laboratories at Fort Detrick

Board on Life Sciences

Division on Earth and Life Studies

NATIONAL RESEARCH COUNCIL
OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

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Committee to Review the Health and Safety Risks of High-Biocontainment Laboratories at Fort Detrick Board on Life Sciences Division on Earth and Life Studies

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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 Insti- tute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. This project was supported by Contract No. W81K04-06-D-0023 between the National Academy of Sciences and the U.S. Department of Defense. Any opinions, findings, con- clusions, 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. International Standard Book Number-13: 978-0-309-15145-0 International Standard Book Number-10: 0-309-15145-7 Additional copies of this report are available from The National Academies Press 500 Fifth Street, NW Box 285 Washington, DC 20055 800-624-6242 202-334-3313 (in the Washington metropolitan area) http://www.nap.edu Copyright 2010 by the National Academy of Sciences. All rights reserved. Printed in the United States of America

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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 re- sponsibility 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 Na- tional 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 THE HEALTH AND SAFETY RISKS OF HIGH-BIOCONTAINMENT LABORATORIES AT FORT DETRICK Members CHARLES N. HAAS (Chair), Drexel University, Philadelphia, Pennsylvania NANCY D. CONNELL, University of Medicine and Dentistry of New Jersey, Newark, New Jersey DONALD A. HENDERSON, University of Pittsburgh Medical Center, Baltimore, Maryland MARK T. HERNANDEZ, University of Colorado at Boulder, Boulder, Colorado BARBARA JOHNSON, Barbara Johnson & Associates, LLC, Herndon, Virginia HENRY M. MATHEWS, Independent Consultant, Atlanta, Georgia TIMOTHY C. RELUGA, Pennsylvania State University, University Park, Pennsylvania JONATHAN Y. RICHMOND, Jonathan Richmond and Associates, Southport, North Carolina LEONARD M. SIEGEL, Center for Public Environmental Oversight, Mountain View, California Staff SUSAN N. J. MARTEL, Project Director FRANCES E. SHARPLES, Director, Board on Life Sciences KATHI E. HANNA, Editor MIRSADA KARALIC-LONCAREVIC, Manager, Technical Information Center RADIAH ROSE, Manager, Editorial Projects TAMARA DAWSON, Program Associate Sponsor U.S. DEPARTMENT OF DEFENSE v

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BOARD ON LIFE SCIENCES Members KEITH R. YAMAMOTO (Chair), University of California, San Francisco, California ANN M. ARVIN, Stanford University, Stanford, California BONNIE L. BASSLER, Princeton University, New Jersey VICKI L. CHANDLER, Gordon and Betty Moore Foundation, Palo Alto, California SEAN EDDY, HHMI Janelia Farm Research Campus, Ashburn, Virginia MARK D. FITZSIMMONS, John D. and Catherine T. MacArthur Foundation, Chicago, Illinois DAVID R. FRANZ, Midwest Research Institute, Frederick, Maryland LOUIS J. GROSS, University of Tennessee, Knoxville, Tennessee JO HANDELSMAN, University of Wisconsin, Madison, Wisconsin CATO T. LAURENCIN, University of Connecticut Health Center, Farmington, Connecticut JONATHAN D. MORENO, University of Pennsylvania, Philadelphia, Pennsylvania ROBERT M. NEREM, Georgia Institute of Technology, Atlanta, Georgia CAMILLE PARMESAN, University of Texas, Austin, Texas MURIEL E. POSTON, Skidmore College, Saratoga Springs, New York ALISON G. POWER, Cornell University, Ithaca, New York BRUCE W. STILLMAN, Cold Spring Harbor Laboratory, Cold Spring Harbor, New York CYNTHIA WOLBERGER, Johns Hopkins University School of Medicine, Baltimore, Maryland MARY WOOLLEY, Research!America, Alexandria, Virginia Staff FRANCES E. SHARPLES, Director JO L. HUSBANDS, Scholar/Senior Project Director ADAM P. FAGEN, Senior Program Officer ANN H. REID, Senior Program Officer MARILEE K. SHELTON-DAVENPORT, Senior Program Officer INDIA HOOK-BARNARD, Program Officer ANNA FARRAR, Financial Associate CARL-GUSTAV ANDERSON, Senior Program Assistant AMANDA P. CLINE, Senior Program Assistant AMANDA MAZZAWI, Program Assistant vi

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Preface There has been vocal public opposition to the expansion of the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) at Fort Detrick in Frederick, Maryland. The laboratory studies infectious agents that could cause serious and potentially lethal diseases by the inhalation route of exposure. Al- though work with such agents must be conducted in laboratories designed and operated to prevent release of agents into the environment, the public is skepti- cal that public health considerations have been adequately considered in the Army’s Environmental Impact Statement (EIS), which supports the construction of the new facility. To address these concerns, Congress directed the Secretary of Defense to commission a National Research Council study of the health and safety aspects of the EIS and other relevant information regarding health risks associated with work with infectious agents (PL 110-329). The National Research Council convened the Committee to Review the Health and Safety Risks of High-Biocontainment Laboratories at Fort Detrick, which prepared this report. The members of the committee were selected for their expertise in biosafety, infectious diseases, industrial hygiene, environ- mental engineering, risk assessment, epidemiology, and stakeholder participa- tion (see Appendix A for biographic information on the members). The committee held two public meetings to gather information to address its task. At the first meeting, held September 22, 2009, in Frederick, Maryland, the committee met with USAMRIID staff (COL Roger Martin, Deputy Com- mander; Shawn Boesen, Chief of Safety; and LTC James Wadding, Chief of the Medicine Division) and contractors (John Beaver, BSA Environmental) to ob- tain background on the EIS, learn about the plans for the new biocontainment facilities, get an overview of the procedures and regulations currently in place to reduce exposure to pathogens, and learn about the history of laboratory-acquired infections at USAMRIID. The committee also heard from representatives of the Frederick County Board of Commissioners—Jan Gardner (President), David Gray (Vice President), and Kai Hagen—and from interested members of the general public. At the second meeting, held November 5, 2009, in Washington, D.C., the committee met with COL John Skvorak, Commander of USAMRIID, to learn about the institute’s biosurety plans for its facilities and personnel. Pres- vii

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viii Preface entations also were given by David Eskildsen, the Fort Detrick Fire Chief, on fire and emergency services, and by Robert VanAtta, the Fort Detrick Emer- gency Manager, on USAMRIID’s biological mishap and incident response pro- gram. The committee also was briefed by Carol Tobias of the Barquist Army Health Clinic about the memorandums of understanding and agreement between the clinic and Frederick Memorial Hospital. The committee also had separate meetings with the medical and security staff of Frederick Memorial Hospital, officials from Frederick County’s emergency management and health depart- ments, and representatives from the community. In particular the committee wishes to thank the following individuals for their time and constructive com- ments: Frederick County representatives Jack Markey, Director of Emergency Management, and Dr. Barbara Brookmyer, Health Officer; Frederick Memorial Hospital staff Dr. Manuel Casiano, Chief of Staff, John Veltri, Director of Safety and Security, and Phil Guiliano, Security Manager; and community members Paul Gordon, Barry Kissin, Bob White, Beth Willis, and John Willis. This report has been reviewed in draft form by persons chosen for their diverse perspectives and technical expertise, in accordance with procedures ap- proved by the National Research Council’s Report Review Committee. The pur- pose 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 manu- script remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report: Michael S. Ascher, California Emergency Management Agency; Richard A. Berman, Manhattanville College (retired); Gerardo Chowell, Arizona State University; Margaret E. Coleman, Upstate New York Society for Risk Analysis; Robert P. Ellis, Colorado State University; Richard Frothingham, Duke University School of Medicine; Paul Langevin, Merrick Canada ULC; and Paul A. Locke, Johns Hopkins Bloomberg School of Public Health. 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 Michael R. Ladisch, Purdue Univer- sity, and Georges C. Benjamin, American Public Health Association. 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 institution. The committee is grateful for the assistance of National Research Council staff in preparing the report. It particularly wishes to acknowledge the support of Project Director Susan Martel, who coordinated the project and contributed to the committee’s report. Other staff members who contributed to this effort are Frances Sharples, director of the Board on Life Sciences; Joyce Wondolowski,

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ix Preface Christine Mirzayan Fellow; Tamara Dawson, program associate; Kathi Hanna, editor; Mirsada Karalic-Loncarevic, manager of the Technical Information Cen- ter; and Radiah Rose, manager, editorial projects. Finally, I thank all the members of the committee for their efforts throughout the development of this report. Charles N. Haas, Ph.D., Chair Committee to Review the Health and Safety Risks of High-Biocontainment Laboratories at Fort Detrick

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Abbreviations ABSA American Biological Safety Association ACGIH American Conference of Governmental Industrial Hygienists AIHA American Industrial Hygiene Association ANSI American National Standards Institute APHA American Public Health Association APHIS Animal and Plant Health Inspection Service AR Army Regulation ASCE American Society of Civil Engineers ASM American Society of Microbiology AWWA American Water Works Association BMBL Biosafety in Microbiological and Biomedical Laboratories BSAT biological select agents and toxins BSC biological safety cabinet BSL biosafety level CDC Centers for Disease Control and Prevention CFR Code of Federal Regulations DA PAM Department of the Army Pamphlet DHS U.S. Department of Homeland Security DOD Department of Defense DOE U.S. Department of Energy DOJ Department of Justice DSB Defense Science Board DTRA Defense Threat Reduction Agency EIS Environmental Impact Statement FBI Federal Bureau of Investigation GAO Government Accountability Office GSU Georgia State University HEPA high-efficiency particulate air HHS U.S. Department of Health and Human Services HPAC Hazard Prediction and Assessment Capability IBC Institutional Biosafety Committee LBM Laboratory Biosafety Manual xi

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xii Abbreviations MCE maximum credible event NADC National Animal Disease Center NEPA National Environmental Policy Act NIAID National Institute of Allergy and Infectious Diseases NICD National Institute for Communicable Diseases NIH National Institutes of Health NRC National Research Council PPE personal protective equipment SIP special immunization program SOP standard operating procedure USAG U.S. Army Garrison USAMRIID U.S. Army Medical Research Institute of Infectious Diseases USAMRMC U.S. Army Medical Research and Materiel Command USDA U.S. Department of Agriculture UTMB University of Texas Medical Branch VEE Venezuelan equine encephalitis WEF Water Environment Federation WHO World Health Organization

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Contents ABBREVIATIONS ........................................................................................... xi SUMMARY ........................................................................................................ 3 1 INTRODUCTION ............................................................................. 13 Context, 14 Committee’s Approach, 15 Organization of the Report, 17 2 COMPARATIVE EVALUATION OF PROCEDURES AND REGULATIONS FOR BIOCONTAINMENT FACILITIES........ 18 Biocontainment, 18 Biosafety at USAMRIID Relative to NIH and CDC Rules and Guidelines, 22 Biosurety, 30 Biosecurity, 32 Case Studies of Recent Events at USAMRIID, 33 Findings, 35 Recommendations, 36 3 MEDICAL AND EMERGENCY MANAGEMENT RESPONSE ....................................................................................... 37 Medical and Public Health Services, 37 Emergency Management Response, 39 Findings, 40 Recommendations, 41 4 REVIEW OF THE USAMRIID ENVIRONMENTAL IMPACT STATEMENT ................................................................... 42 Potential Scenarios in the Context of Maximum Credible Events and Risks to the Community, 42 xiii

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xiv Contents Potential Scenarios in the Context of Maximum Credible Events and Risks to Personnel, 49 Consideration of Alternative Construction Sites, 52 Findings, 53 Recommendation, 54 5 COMMUNICATION AND COOPERATION WITH THE PUBLIC ..................................................................................... 55 Roots of Public Concern, 55 Public Concerns about the Release of Pathogens, 56 The Importance of Trust, 57 A New Approach to Communications and Cooperation with the Public, 59 Findings, 61 Recommendations, 61 REFERENCES ................................................................................................. 62 APPENDIX BIOGRAPHICAL INFORMATION ON THE COMMITTEE TO REVIEW THE HEALTH AND SAFETY RISKS OF HIGH- BIOCONTAINMENT LABORATORIES AT FORT DETRICK .............. 66 BOXES, FIGURE, AND TABLES BOXES 1-1 Excerpts from DOE (2004) Recommendations for Analyzing Human Health Impacts in EISs, 16 2-1 Pathogenic Agents Recently Studied or Potentially Studied in the Near Future at USAMRIID, 30 FIGURE 2-1 USAMRIID’s Biosurety Program, 19 TABLES 2-1 Timeline of Significant Advances in Biocontainment, Biosafety, Biosurety, and Biosecurity, and Listing (by Decade) of Laboratory- Acquired Infections at USAMRIID, 25

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xv Contents 4-1 Personnel Hours Worked and Outcomes of Accidental Exposures to Infectious Agents: Intramural National Institute of Allergy and Infectious Diseases 1982-2003, 50 4-2 Personnel Hours Worked and Outcomes of Accidental Exposures to BSL-4 Agents 1972-2003, 50

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