Evaluation of the Updated

Site-Specific Risk Assessment for the

NATIONAL BIO- AND AGRO-DEFENSE

FACILITY IN MANHATTAN, KANSAS

Committee on the Evaluation of the Updated Site-Specific Risk Assessment
for the National Bio- and Agro-Defense Facility in Manhattan, Kansas

Board on Life Sciences

Board on Agriculture and Natural Resources

Division on Earth and Life Studies

NATIONAL RESEARCH COUNCIL
OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS
Washington, D.C.
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Evaluation of the Updated Site-Specific Risk Assessment for the NATIONAL BIO- AND AGRO-DEFENSE FACILITY IN MANHATTAN, KANSAS Committee on the Evaluation of the Updated Site-Specific Risk Assessment for the National Bio- and Agro-Defense Facility in Manhattan, Kansas Board on Life Sciences Board on Agriculture and Natural Resources 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 Institute of Medicine. The members of the committee respon- sible for the report were chosen for their special competences and with regard for appropriate balance. This study was supported by Task Order HSFLBP-11-J-00002/Contract HSHQDC- 11-D-00009 between the National Academy of Sciences and Department of Home- land Security. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the authors and do not necessarily reflect the views of the organizations or agencies that provided support for the project. International Standard Book Number-13: 978-0-309-25782-4 International Standard Book Number-10: 0-309-25782-4 Additional copies of this report 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 2012 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 Acad- emy 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 en- gineers. 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 engineer- ing programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is presi- dent 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 Insti- tute 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 Sci- ences 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 Coun- cil 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 ON THE EVALUATION OF THE UPDATED SITE- SPECIFIC RISK ASSESSMENT FOR THE NATIONAL BIO- AND AGRO-DEFENSE FACILITY IN MANHATTAN, KANSAS GREGORY B. BAECHER (Chair), University of Maryland, College Park, MD THOMAS W. ARMSTRONG, TWA8HR Occupational Hygiene Consulting, LLC, Branchburg, NJ RICHARD E. BREITMEYER, University of California, Davis, CA CORRIE C. BROWN, University of Georgia, Athens, GA MARK T. HERNANDEZ, University of Colorado Boulder, Boulder, CO AHSAN KAREEM, University of Notre Dame, Notre Dame, IN BRENDAN MCCLUSKEY, University of Medicine and Dentistry of New Jersey, Newark, NJ ALI MOSLEH, University of Maryland, College Park, MD STEPHEN M. OSTROFF, Pennsylvania Department of Health, Harrisburg, PA PHILIP L. PAARLBERG, Purdue University, West Lafayette, IN TIMOTHY C. RELUGA, Pennsylvania State University, University Park, PA JOSEPH V. RODRICKS, ENVIRON, Arlington, VA JAMES A. ROTH, Iowa State University, Ames, IA LEE H. THOMPSON, University of Texas Medical Branch at Galveston, Galveston, TX MARK C. THURMOND, University of California, Davis, CA AKULA VENKATRAM, University of California, Riverside, CA PATRICK M. WEBB, National Pork Board, Des Moines, IA Staff PEGGY TSAI, Study Director and Program Officer CARL-GUSTAV ANDERSON, Program Associate KATHLEEN REIMER, Senior Program Assistant FRANCES E. SHARPLES, Director, Board on Life Sciences ROBIN A. SCHOEN, Director, Board on Agriculture and Natural Resources NORMAN GROSSBLATT, Senior Editor v

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BOARD ON LIFE SCIENCES KEITH R. YAMAMOTO (Chair), University of California, San Francisco, CA BONNIE L. BASSLER, Princeton University, Princeton, NJ VICKI L. CHANDLER, Gordon and Betty Moore Foundation, Palo Alto, CA SEAN EDDY, HHMI Janelia Farm Research Campus, Ashburn, VA MARK FITZSIMMONS, John D. and Catherine T. MacArthur Foundation, Chicago, IL DAVID R. FRANZ, Former Cdr USAMRIID, Frederick, MD LOUIS J. GROSS, University of Tennessee, Knoxville, TN RICHARD A. JOHNSON, Arnold & Porter, LLC, Washington, DC CATO T. LAURENCIN, University of Connecticut Health Center, Farmington, CN ALAN I. LESHNER, American Association for the Advancement of Science, Washington, DC BERNARD LO, University of California, San Francisco, CA ROBERT M. NEREM, Georgia Institute of Technology, Atlanta, GA MURIEL E. POSTON, Skidmore College, Saratoga Springs, NY ALISON G. POWER, Cornell University, Ithaca, NY MARGARET RILEY, University of Massachusetts, Amherst, MA BRUCE W. STILLMAN, Cold Spring Harbor Laboratory, Cold Spring Harbor, NY CYNTHIA WOLBERGER, Johns Hopkins University School of Medicine, Baltimore, MD MARY WOOLLEY, Research!America, Alexandria, VA Staff FRANCES E. SHARPLES, Board Director JO L. HUSBANDS, Scholar/Senior Project Director JAY B. LABOV, Senior Scientist/Program Director for Biology Education KATHERINE W. BOWMAN, Senior Program Officer INDIA HOOK-BARNARD, Senior Program Officer MARILEE K. SHELTON-DAVENPORT, Senior Program Officer KEEGAN SAWYER, Program Officer BETHELHEM M. BANJAW, Financial Associate ORIN E. LUKE, Senior Program Assistant CARL-GUSTAV ANDERSON, Program Associate SAYYEDA AYESHA AHMED, Senior Program Assistant vi

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BOARD ON AGRICULTURE AND NATURAL RESOURCES NORMAN R. SCOTT (Chair),1 Cornell University, Ithaca, NY PEGGY F. BARLETT, Emory University, Atlanta, GA HAROLD L. BERGMAN, University of Wyoming, Laramie, WY RICHARD A. DIXON,2 Samuel Roberts Noble Foundation, Ardmore, OK DANIEL M. DOOLEY, University of California, Oakland, CA JOAN H. EISEMANN, North Carolina State University, Raleigh, NC GARY F. HARTNELL, Monsanto Company, St. Louis, MO GENE HUGOSON, Global Initiatives for Food Systems Leadership, St. Paul, MN MOLLY M. JAHN, University of Wisconsin-Madison, WI ROBBIN S. JOHNSON, Cargill Foundation, Wayzata, MN A.G. KAWAMURA, Solutions from the Land, Washington, DC KIRK C. KLASING, University of California, Davis, CA JULIA L. KORNEGAY, North Carolina State University, Raleigh, NC VICTOR L. LECHTENBERG, Purdue University, West Lafayette, IN JUNE BOWMAN NASRALLAH,2 Cornell University, Ithaca, NY PHILIP E. NELSON, Purdue University, West Lafayette, IN KEITH PITTS, Marrone Bio Innovations, Davis, CA CHARLES W. RICE, Kansas State University, Manhattan, KS HAL SALWASSER, Oregon State University, Corvallis, OR ROGER A. SEDJO, Resources for the Future, Washington, DC KATHLEEN SEGERSON, University of Connecticut, Storrs, CN MERCEDES VAZQUEZ-AÑON, Novus International, Inc., St. Charles, MO Staff ROBIN A. SCHOEN, Board Director AUSTIN J. LEWIS, Senior Program Officer EVONNE P.Y. TANG, Senior Program Officer CAMILLA YANDOC ABLES, Program Officer KARA N. LANEY, Program Officer PEGGY TSAI, Program Officer JANET M. MULLIGAN, Senior Program Associate for Research RUTH S. ARIETI, Research Associate KAREN L. IMHOF, Administrative Coordinator KATHLEEN REIMER, Senior Program Assistant 1Member of the National Academy of Engineering 2Member of the National Academy of Sciences vii

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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 its 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 process. We wish to thank the following individuals for their review of this report: Nancy D. Connell, University of Medicine and Dentistry of New Jersey Armen der Kiureghian, University of California at Berkeley Charles N. Haas, Drexel University Bob R. Hillman, Animal Health Matters, LLC Barbara Johnson, Johnson & Associates, LLC Joseph B. Kadane, Carnegie Mellon University James W. Le Duc, University of Texas Medical Branch at Galveston Linda L. Logan, Texas A&M University Frederick A. Murphy, University of Texas Medical Branch at Galveston Mitchell J. Small, Carnegie Mellon University Gary Smith, University of Pennsylvania Alan Washburn, Naval Postgraduate School Alex Winter-Nelson, University of Illinois at Urbana-Champaign ix

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x ACKNOWLEDGMENTS 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 Dr. Lynn Goldman, George Washington University, and Dr. Ann Arvin, Stanford University School of Medicine. 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.

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Preface Protecting the nation’s food supply system from foreign animal diseases and protecting our citizenry and the peoples of the world from zoonotic diseases requires advanced research capabilities. That in turn means that there is a need for safe and highly secure laboratories in which to conduct research, develop diagnostic capabilities, and develop vaccines. To that end, the Department of Homeland Security (DHS) is planning to construct a new National Bio- and Agro-Defense Facility (NBAF) in Manhattan, Kansas, to replace the aging Plum Island Animal Disease Center in New York. Once completed, the NBAF will join facilities in Australia, Canada, and Germany to become the fourth functioning biosafety level 4 (BSL-4) agricultural re- search center in the world to conduct work on large animals. Foreign animal diseases, such as foot-and-mouth disease (FMD), are ones that are not endemic in the United States and may have a great impact on our agricultural economy if an outbreak occurs in the United States. Many important foreign animal diseases are not zoonotic and cannot be transmitted to humans. Nonetheless, they pose a threat of immense eco- nomic impact on American agriculture. Other high-consequence biological threats involving animal and zoonotic diseases will also be studied at the NBAF. About 65% of emerging infectious diseases over the last 50 years have been zoonotic. Studying emerging and new infectious diseases will require capabilities for research with large animals (including BSL-4), and these capabilities will be critical for addressing future unknown threats. Although there is wide agreement that the country needs a facility like the NBAF, the Government Accountability Office raised the question of whether FMD research can be safely conducted on the mainland of the xi

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xii PREFACE United States. When the decision was made to construct the facility in Manhattan, Kansas, further concerns were raised about building the facility in the middle of Tornado Alley and in the heart of cattle country. Congress thus instructed DHS to conduct a site-specific risk assessment (SSRA) of the potential release of FMD virus from the new facility in Manhattan and the consequent infection, spread, and economic impact. Congress further instructed DHS to seek a review of the risk assessment by a scientific and technical committee of the National Research Council. DHS and its contractors prepared the site-specific risk assessment and made it public in 2010, and it was reviewed by a committee of the National Research Council. While that committee found the assessment to be a nota- ble first step in an iterative process aimed at identifying and minimizing risk and determining actions that will need to be taken, it nonetheless found the assessment not entirely adequate or valid. Congress subsequently mandated in the Department of Defense and Full-Year Continuing Appropriations Act of 2011 (P.L. 112-10, Sec. 1647) that DHS prepare an updated SSRA (uSSRA) to address concerns raised by the committee’s review. The uSSRA is based on the 65% design phase planning documents for the facility and the uSSRA is the subject of this committee’s evaluation. The present report is directed to Congress, DHS, stakeholders among the nation’s citizenry, and interested scientific and technical communities. As noted in the 2009 National Research Council report Science and Decisions: “risk assessment has become a dominant public-policy tool for informing risk managers and the public about the different policy options for protecting public health and the environment. Risk assessment has been instrumental in fulfilling the missions of . . . federal and state agencies in evaluating public-health concerns, informing regulatory and technologic decisions, setting priorities for research and funding, and developing ap- proaches for cost-benefit analyses.” The purposes of risk assessment in the context of the NBAF are to • Provide a systematic and valid approach to evaluating potential ac- cident events and scenarios that might lead to the release of pathogens from the facility in Manhattan, Kansas, and the potential consequences thereof. • Include surveillance, response, and mitigation plans for detecting and controlling the spread of disease. • Characterize uncertainties in calculated results based on state-of- the-art risk analysis practice. • Incorporate peer-reviewed and validated models and scientific data in the analysis. • Develop and use a method of estimating the cumulative risk of an FMD infection resulting from an accidental release from the Kansas site over the operating lifetime of the facility.

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xiii PREFACE In the process of reviewing the uSSRA, the committee had the oppor- tunity to hear public comments on the proposed facility and on the risk assessment. These were heard during public sessions in Washington, DC, and during a visit to the proposed site in Manhattan, Kansas, and a tour of the existing Kansas State University Biosecurity Research Institute. The purpose of the site visit was for the committee to better understand specific considerations for the facility. The committee thanks the many members of the public who contributed comments to the evaluation process. The committee also acknowledges and thanks the U.S. and interna- tional experts who volunteered their time to attend early meetings of the committee and to provide their perspectives and experience. They included Soren Alexandersen, Christopher Broder, Charles Haas, Michael Johnson, Thomas Ksiazek, Paul Langevin, Thomas Mettenleiter, Gay Miller, Gregory Paoli, Barrett Slenning, Gregory Smith, Alfonso Torres, Hana Weingartl, and Neal Woollen. On behalf of the committee, I would like to thank the National Re- search Council staff who invested great effort and energy in supporting the committee’s work throughout the preparation of this report. I also thank the members of the committee for unselfishly contributing their services and for the collegiality of their efforts. Gregory B. Baecher, Chair Committee on the Evaluation of the Updated Site-Specific Risk Assessment for the National Bio- and Agro-Defense Facility in Manhattan, Kansas

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Contents ACRONYMS AND ABBREVIATIONS xix SUMMARY 1 1 INTRODUCTION 9 Unique Capabilities and Risks Associated with the NBAF, 9 Proposed Site in Manhattan, Kansas, 11 Previous Assessments, 11 Congressional Mandate and Statement of Task, 13 Committee’s Approach to its Task, 15 Organization of the Report, 16 References, 16 2 EVALUATION OF DESIGN, OPERATIONS, AND RESPONSE PLANNING AS RELATED TO THE RISK ASSESSMENT 19 Design Plans, 19 Standard Operating Procedures, Personnel Training, and Emergency Response Planning, 20 Reference, 21 3 EVALUATION OF RISK APPROACH AND CALCULATIONS 23 Risk Modeling Framework, 23 Application of Risk Methods in the uSSRA, 23 Specific Cross-Cutting Issues, 25 Input Data and Parameter Estimates, 32 xv

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xvi CONTENTS Concerns About Quantitative Analysis Practices, 33 References, 35 4 EVALUATION OF ACCIDENT EVENT MODELING 37 Overview of Methods for Accident Event Modeling, 37 Commentary, 38 Terminology, 38 Logic Errors and Event Trees, 39 Development of Failure Probabilities and Reduction Factors, 39 General Findings on Data Inputs, 39 Modeling of Catastrophic Natural Hazards, 44 Tornadoes, 44 Earthquakes, 46 References, 47 5 EVALUATION OF FATE AND TRANSPORT MODELING 49 Modifications in Use of the Model and Parameters, 49 Shortcomings in the Application of SCIPUFF, 49 Shortcomings in Modeling Airborne Spread in NAADSM, 50 References, 51 6 EVALUATION OF EPIDEMIC MODELING 53 Overview of Methods and Analysis, 53 Summary Assessment, 54 Methodological Limitations, 55 References, 61 7 EVALUATION OF ECONOMIC MODELING 63 Overview of Methods and Analysis, 63 Inaccurate Descriptions of Methods and Analysis, 64 Insufficient Information Provided to Verify Results, 64 Partial Equilibrium Model Analysis, 65 Regional Model Analysis, 66 Non-Indemnification Costs, 67 Summary, 67 References, 67 8 EVALUATION OF BIOSAFETY LEVEL 4 ASSESSMENT 69 Inadequacy of the Semi-Quantitative Approach, 70 Concerns About BSL-4 Analysis, 70 Concerns About Use of Methods and Models, 72 References, 76

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xvii CONTENTS 9 OVERALL ASSESSMENT, FINDINGS, AND CONCLUSIONS 79 Overall Assessment, 79 Findings, 81 Limited Applicability of the Updated Site-Specific Risk Assessment, 87 Conclusions, 88 References, 88 APPENDIXES A Committee Biosketches 93 B Meeting Agendas and Lists of Public Participants 103 BOXES 1-1 Findings of the 2010 National Research Council Review of the DHS Site-Specific Risk Assessment for the National Bio- and Agro-Defense Facility, 12 1-2 Department of Defense and Full Year Continuing Appropriations Act, 2011, 13 1-3 Statement of Task, 14

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Acronyms and Abbreviations ABSL animal biosafety level ACRE average crop revenue election AHR animal handling room ATR transfer of aerosolized infectious material into the nasal passages of a researcher when researchers are in an AHR BSL biosafety level CDC Centers for Disease Control and Prevention DHS U.S. Department of Homeland Security EIS environmental impact statement EMAP Emergency Management Accreditation Program FAD foreign animal disease FMD foot-and-mouth disease FMDv foot-and-mouth disease virus GAO U.S. Government Accountability Office HEPA high-efficiency particulate air HeV Hendra virus HRA human reliability analysis HSPD-9 Homeland Security Presidential Directive 9 xix

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xx ACRONYMS AND ABBREVIATIONS IATA International Air Transport Association IOM Institute of Medicine KDE kernel density estimation KDHE Kansas Department of Health and Environment LD lethal dose MAR material available for release NAADSM North American Animal Disease Spread Model NAHLN National Animal Health Laboratory Network NBAF National Bio- and Agro-Defense Facility NFPA National Fire Protection Association NiV Nipah virus NOAA U.S. National Oceanic and Atmospheric Administration OIE World Organization for Animal Health OTB spill of a shipment of FMDv results in transference to the body in non-containment areas PFU plaque-forming unit PIADC Plum Island Animal Disease Center PNNL Pacific Northwest National Laboratory POE probability of exceedance RIMS II Regional Input-Output Modeling System SCIPUFF Second-order Closure Integrated Puff Model SOP standard operating procedure SSRA site-specific risk assessment USAMRIID U.S. Army Medical Research Institute for Infectious Diseases USDA U.S. Department of Agriculture USGS U.S. Geological Survey uSSRA updated site-specific risk assessment