Meeting Critical
Laboratory Needs
for Animal Agriculture

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Examination of Three Options

Committee on an Analysis of the Requirements and
Alternatives for Foreign Animal and Zoonotic Disease
Research and Diagnostic Laboratory Capabilities

Board on Agriculture and Natural Resources
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 on an Analysis of the Requirements and Alternatives for Foreign Animal and Zoonotic Disease Research and Diagnostic Laboratory Capabilities Board on Agriculture and Natural Resources 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 Na- tional 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 HSHQDC-11-D-00009/Task Order HSFLBP-12-J- 00001 between the National Academy of Sciences and the Department of Homeland Secu- rity. 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 agen- cies that provided support for the project. International Standard Book Number-13: 978-0-309-26129-6 International Standard Book Number-10: 0-309-26129-5 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 (Washington metropolitan area); 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 dis- tinguished scholars engaged in scientific and engineering research, dedicated to the further- ance 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 Na- tional Academy of Sciences the responsibility for advising the federal government. The Na- tional Academy of Engineering also sponsors engineering programs aimed at meeting na- tional 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 pur- poses of furthering knowledge and advising the federal government. Functioning in accor- dance with general policies determined by the Academy, the Council has become the princi- pal 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 engi- neering communities. The Council is administered jointly by both Academies and the Insti- tute 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 AN ANALYSIS OF THE REQUIREMENTS AND ALTERNATIVES FOR FOREIGN ANIMAL AND ZOONOTIC DISEASE RESEARCH AND DIAGNOSTIC LABORATORY CAPABILITIES Members TERRY MCELWAIN (Chair), Washington State University, Pullman, Washington NANCY CONNELL, University of Medicine and Dentistry of New Jersey, Newark DAVID HENNESSY, Iowa State University, Ames LONNIE J. KING, The Ohio State University, Columbus JAMES LE DUC, The University of Texas Medical Branch at Galveston N. JAMES MACLACHLAN, University of California, Davis BRET MARSH, Indiana State Board on Animal Health, Indianapolis MO SALMAN, Colorado State University, Fort Collins ALFONSO TORRES, Cornell University, Ithaca, New York CHRISTOPHER WOLF, Michigan State University, East Lansing Staff CAMILLA YANDOC ABLES, Study Director and Program Officer KATHERINE BOWMAN, Senior Program Officer PEGGY TSAI, Program Officer KAREN IMHOF, Administrative Coordinator ROBIN A. SCHOEN, Director, Board on Agriculture and Natural Resources FRANCES E. SHARPLES, Director, Board on Life Sciences NORMAN GROSSBLATT, Senior Editor v

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BOARD ON AGRICULTURE AND NATURAL RESOURCES Members NORMAN R. SCOTT (Chair), Cornell University (Emeritus), Ithaca, New York PEGGY F. BARLETT, Emory University, Atlanta, Georgia HAROLD L. BERGMAN, University of Wyoming, Laramie RICHARD A. DIXON, Samuel Roberts Noble Foundation, Ardmore, Oklahoma DANIEL M. DOOLEY, University of California, Oakland JOAN H. EISEMANN, North Carolina State University, Raleigh GARY F. HARTNELL, Monsanto Company, St. Louis, Missouri GENE HUGOSON, Global Initiatives for Food Systems Leadership, St. Paul, Minnesota MOLLY M. JAHN, University of Wisconsin-Madison ROBBIN S. JOHNSON, Cargill Foundation, Wayzata, Minnesota A.G. KAWAMURA, Solutions from the Land, Washington, DC KIRK C. KLASING, University of California, Davis JULIA L. KORNEGAY, North Carolina State University, Raleigh VICTOR L. LECHTENBERG, Purdue University, West Lafayette, Indiana JUNE BOWMAN NASRALLAH, Cornell University, Ithaca, New York PHILIP E. NELSON, Purdue University (Emeritus), West Lafayette, Indiana KEITH PITTS, Marrone Bio Innovations, Davis, California CHARLES W. RICE, Kansas State University, Manhattan HAL SALWASSER, Oregon State University, Corvallis ROGER A. SEDJO, Resources for the Future, Washington, DC KATHLEEN SEGERSON, University of Connecticut, Storrs MERCEDES VÁZQUEZ-AÑÓN, Novus International, Inc., St. Charles, Missouri Staff ROBIN A. SCHOEN, Board Director EVONNE P.Y. TANG, Senior Program Officer CAMILLA YANDOC ABLES, Program Officer KARA N. LANEY, Program Officer PEGGY TSAI, Program Officer KAREN L. IMHOF, Administrative Coordinator JANET M. MULLIGAN, Senior Program Associate for Research KATHLEEN REIMER, Senior Program Assistant vi

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BOARD ON LIFE SCIENCES Members KEITH R. YAMAMOTO (Chair), University of California, San Francisco BONNIE L. BASSLER, Princeton University, Princeton, 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, Former Cdr USAMRIID, Frederick, Maryland LOUIS J. GROSS, University of Tennessee, Knoxville RICHARD A. JOHNSON, Arnold & Porter, LLC, Washington, DC CATO T. LAURENCIN, University of Connecticut Health Center, Farmington ALAN I. LESHNER, American Association for the Advancement of Science, Washington, DC BERNARD LO, University of California, San Francisco ROBERT M. NEREM, Georgia Institute of Technology, Atlanta MURIEL E. POSTON, Skidmore College, Saratoga Springs, New York ALISON G. POWER, Cornell University, Ithaca, New York MARGARET RILEY, University of Massachusetts, Amherst 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, 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 CARL-GUSTAV ANDERSON, Program Associate SAYYEDA AYESHA AHMED, Senior Program Assistant ORIN E. LUKE, Senior Program Assistant vii

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Preface In April 2012, the National Research Council convened a committee to pro- vide advice on the requirements and alternatives for ensuring the nation has the necessary foreign animal and zoonotic disease research and diagnostic labora- tory capabilities. In less than three months after the first public meeting to gather information, held on the rather inauspicious date of Friday the 13th (of April), the committee produced this report that analyzes three options for meeting our nation’s biocontainment facility needs. The committee developed a conceptual framework for an ideal system that would best capture the broad intellectual capital of the United States and would take strategic advantage of investments in laboratory infrastructure during the last decade. It was against this backdrop that the committee considered the three options. The first of three options specified in the committee’s statement of task was to build the National Bio- and Agro- Defense Facility (NBAF) as currently designed. The committee also evaluated whether two alternative options could provide the needed capability and capac- ity for addressing disease threats. These two alternative options were to build an NBAF of reduced size and scope (“NBAF-lite,” as the committee colloquially referred to it during discussions), and to maintain our current national biocon- tainment laboratory on Plum Island, with large-animal biosafety level 4 con- tainment capacity provided by foreign laboratories. A report of this nature and with our timeline does not happen without the commitment and dedicated efforts of many people. That commitment was not only to the task at hand but to a $165 billion animal agricultural enterprise that could suffer catastrophic losses as a result of diseases that are among the world’s most infectious and most virulent. The commitment also extended to a nation that is struggling with economic realities as formidable as any we have faced for 75 years, to a nation that correctly questions a billion-dollar investment in a new facility, and to a leadership that must make decisions about that investment. We trust that this report will be a valuable resource in helping to make critical deci- sions that affect the security of our food supply, the viability of our agriculture industry, and the public health of our country. The committee dedicated itself to this study with those overarching considerations always in mind. ix

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x PREFACE Committee members brought a broad array of experience and expertise to the discussions. Each of them made valuable contributions to this report, and my thanks go to them for their extraordinary efforts. The National Research Council staff who supported the project were outstanding. Their contributions, both di- rectly and behind the scenes, and their timely encouragement of the chair when there seemed to be no possible way to accomplish our task in the allotted time, were invaluable. I thank all of them on behalf of a grateful committee. Terry McElwain, DVM, PhD, Chair Committee on an Analysis of the Requirements and Alternatives for Foreign Animal and Zoonotic Disease Research and Diagnostic Laboratory Capabilities

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Acknowledgments The committee is grateful to all those who participated in our public ses- sions and those who provided information about their laboratories. This report has been reviewed in draft form by persons chosen for their di- verse 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 the report: Ivan Damnjanovic, Texas A&M University John R. Henneman, The Pennsylvania State University James M. Hughes, Emory University Barbara Johnson, Johnson & Associates, LLC Michael Lairmore, University of California, Davis David T. Marshall, North Carolina Department of Agriculture and Consumer Services Thomas McKenna, Wisconsin Veterinary Diagnostic Laboratory John P. Moore, Weill Cornell Medical College Frederick A. Murphy, The University of Texas Medical Branch at Galveston Derrell Peel, Oklahoma State University James A. Roth, Iowa State University Harry Snelson, American Association of Swine Veterinarians 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 the report was overseen by Dr. May Berenbaum, University of xi

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xii ACKNOWLEDGMENTS Illinois at Urbana-Champaign, and Dr. Lynn Goldman, George Washing- ton University. Appointed by the National Research Council, they were re- sponsible for making certain that an independent examination of the report was carried out in accordance with institutional procedures and that all review com- ments were carefully considered. Responsibility for the final content of the re- port rests with the authoring committee and the institution.

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Contents SUMMARY ........................................................................................................ 1 1 INTRODUCTION .................................................................................... 13 Background, 13 The Committee’s Task, 14 Organization of the Report, 17 References, 17 2 CRITICAL NEED TO PROTECT US AGRICULTURE..................... 19 Importance of Animal Agriculture, 19 Critical Infrastructure to Protect Animal Health, 22 Animal Diseases of Concern, 23 Diagnostic Needs, 27 Agroterrorism, 30 Summary, 30 References, 31 3 AN INTEGRATED NATIONAL SYSTEM FOR ADDRESSING FOREIGN ANIMAL DISEASES AND ZOONOTIC DISEASES ................................................................. 35 The Role of a National Laboratory Facility in an Integrated System, 36 Summary, 63 References, 64 4 ANALYSIS AND CONCLUSIONS ABOUT THREE APPROACHES FOR PROVIDING US INFRASTRUCTURE TO COUNTER FOREIGN ANIMAL DISEASE AND ZOONOTIC DISEASE THREATS ............................................................................... 67 Previous Long-Term Planning Efforts, 68 The Laboratory Infrastructure Needed for a Foreign Animal Disease and Zoonotic Disease Research and Diagnostic Facility, Regardless of Location and Size, 71 xiii

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xiv CONTENTS Analysis of Option 1: The Proposed National Bio- and Agro-Defense Facility as Currently Designed, 77 Analysis of Option 2: A National Bio- and Agro-Defense Facility of Reduced Size and Scope, 84 Analysis of Option 3: Maintaining Current Capabilities at Plum Island Animal Disease Center While Leveraging ABSL-4 Large-Animal Capacity Through Foreign Laboratories, 94 Conclusions about the Three Options, 100 Other Options, 100 Summary, 101 References, 101 5 OVERARCHING CONCLUSIONS AND RECOMMENDATION ................................................................ 105 Analysis of the Three Options, 106 Considerations for Fulfilling National Needs, 108 References, 110 APPENDIXES A COMMITTEE BIOSKETCHES ........................................................... 113 B MEETING AGENDAS........................................................................... 119 C BRIEF HISTORY OF THE PLUM ISLAND ANIMAL DISEASE CENTER .............................................................. 123

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List of Tables, Figures, and Boxes TABLES 2-1 World Organisation for Animal Health List of Animal Diseases 2012, 25 2-2 Priority List of Diseases of Concern, 27 2-3 Most Serious Animal Disease Threats in the United States Listed on the National Vaccine Stockpile List, 28 3-1 Selected Federal, State, and University BSL-3Ag, BSL-4 and ABSL-4 Laboratories in the United States and Their Capacity and Capability, 51 3-2 Selected International BSL-3Ag and BSL-4Ag/ABSL-4 Laboratories and Their Capacity and Capability, 54 4-1 Possible Location of Key Laboratory-Based Components of the Ideal System for Countering Foreign Animal and Zoonotic Disease Threats, 75 4-2 Summary of NBAF Capacity and Capabilities, 79 4-3 Numbers and Types of Large Animals that can be Handled in the Proposed NBAF Animal Rooms, 80 4-4 Approximate Facility Size and Construction Cost Reductions, 91 4-5 Comparison of Space Available at PIADC and the Proposed NBAF, 96 FIGURES S-1 Components of an integrated system for addressing foreign animal disease and zoonotic disease threats, 4 3-1 Components of an integrated system for addressing foreign animal disease and zoonotic disease threats, 37 3-2 National Animal Health Laboratory Network, 44 xv

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xvi LIST OF TABLES, FIGURES, AND BOXES 3-3 Selected federal, state, national biocontainment laboratory and regional biocontainment laboratory BSL-3, BSL-3Ag, and BSL-4 facilities, 50 3-4 Rates of performance improvement of recombinant-DNA technology and synthetic biology, 61 4-1 Comparison of the three options analyzed by the committee with the components of an ideal laboratory infrastructure, 71 4-2 Re-envisioned NBAF of reduced size and scope, focusing on critical core components for which capacity cannot be effectively provided at other locations, 85 BOXES S-1 Conclusions and Recommendation for Meeting Critical Laboratory Needs, 10 1-1 Statement of Task, 15 2-1 Summary of Agricultural Screening Tools Workshops Sponsored by DHS, 29 3-1 Laboratory Biosafety Levels and Types of Pathogens Handled at Each Level, 38 3-2 Training Courses Offered at the Plum Island Animal Disease Center, 40 3-3 The National Animal Health Laboratory Network, 43 3-4 Detecting Foot-and-Mouth Disease Virus in Milk: A Case Study of Collaboration, 48 4-1 Vaccine Challenge Studies, 88

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Acronyms and Abbreviations AAHL Australian Animal Health Laboratory AAVLD American Association of Veterinary Laboratory Diagnosticians ABSL animal biosafety level AHRC Animal Health Research Center APHIS USDA Animal and Plant Health Inspection Service ASF African swine fever ARS USDA Agricultural Research Service 50% bovine infectious dose BID50 BMBL Biosafety in Microbiological and Biomedical Laboratories BRI Biosecurity Research Institute BSE bovine spongiform encephalopathy BSL biosafety level CAHFS California Animal Health and Food Safety CDC Centers for Disease Control and Prevention CSF classical swine fever CSIRO Commonwealth Scientific and Industrial Research Organisation CVB Center for Veterinary Biologics DHS US Department of Homeland Security DIVA differentiating infected from vaccinated animals EEDA emerging and exotic diseases of animals ELISA enzyme-linked immunosorbent assay FAD foreign animal disease FAD&E foreign animal diseases and ectoparasites FADD foreign animal disease diagnostics FADDL Foreign Animal Disease Diagnostic Laboratory FAO Food and Agriculture Organization of the United Nations FBI Federal Bureau of Investigation FDA US Food and Drug Administration xvii

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xviii ACRONYMS AND ABBREVIATIONS FLI Friedrich-Loeffler-Institut FMDv foot-and-mouth disease virus FY fiscal year GNL Galveston National Laboratory HSADL High Security Animal Disease Laboratory HSPD Homeland Security Presidential Directive IAH Institute for Animal Health IRF Integrated Research Facility ITAD international transboundary animal disease IVI Institute of Virology and Immunoprophylaxis NADC National Animal Disease Center NAHLN National Animal Health Laboratory Network NBACC National Biodefense Analysis and Countermeasures Center NBAF National Bio- and Agro-Defense Facility NBL National Biocontainment Laboratory NCAH National Centers for Animal Health NCFAD National Centre for Foreign Animal Disease NEIDL National Emerging Infectious Diseases Laboratory NIAID National Institute of Allergy and Infectious Diseases NIH National Institutes of Health NVSL National Veterinary Services Laboratories O&M operations and maintenance OIE World Organisation for Animal Health PAAR Plant Animal Agrosecurity Research PANAFTOSA Pan-American Foot-and-Mouth Disease Center PCR polymerase chain reaction PGP percentage of protection against generalized foot infection PIADC Plum Island Animal Disease Center PPE personal protective equipment RBL Regional Biocontainment Laboratory RCE Regional Center of Excellence for Biodefense and Emerging Infectious Diseases RML Rocky Mountain Laboratories SARS severe acute respiratory syndrome SEPRL Southeast Poultry Research Laboratory TAD transboundary animal diseases TB-LAM tuberculosis-lipoarabinomannan USAMRIID US Army Medical Research Institute for Infectious Diseases USDA US Department of Agriculture VSTA Virus Serum Toxin Act