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Suggested Citation:"Appendix B: Preliminary Letter Report." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"Appendix B: Preliminary Letter Report." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"Appendix B: Preliminary Letter Report." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"Appendix B: Preliminary Letter Report." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"Appendix B: Preliminary Letter Report." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"Appendix B: Preliminary Letter Report." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"Appendix B: Preliminary Letter Report." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"Appendix B: Preliminary Letter Report." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"Appendix B: Preliminary Letter Report." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"Appendix B: Preliminary Letter Report." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"Appendix B: Preliminary Letter Report." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"Appendix B: Preliminary Letter Report." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"Appendix B: Preliminary Letter Report." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"Appendix B: Preliminary Letter Report." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"Appendix B: Preliminary Letter Report." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"Appendix B: Preliminary Letter Report." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"Appendix B: Preliminary Letter Report." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"Appendix B: Preliminary Letter Report." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"Appendix B: Preliminary Letter Report." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"Appendix B: Preliminary Letter Report." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"Appendix B: Preliminary Letter Report." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"Appendix B: Preliminary Letter Report." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"Appendix B: Preliminary Letter Report." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"Appendix B: Preliminary Letter Report." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"Appendix B: Preliminary Letter Report." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"Appendix B: Preliminary Letter Report." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"Appendix B: Preliminary Letter Report." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"Appendix B: Preliminary Letter Report." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"Appendix B: Preliminary Letter Report." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"Appendix B: Preliminary Letter Report." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"Appendix B: Preliminary Letter Report." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"Appendix B: Preliminary Letter Report." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"Appendix B: Preliminary Letter Report." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"Appendix B: Preliminary Letter Report." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"Appendix B: Preliminary Letter Report." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"Appendix B: Preliminary Letter Report." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"Appendix B: Preliminary Letter Report." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"Appendix B: Preliminary Letter Report." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"Appendix B: Preliminary Letter Report." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"Appendix B: Preliminary Letter Report." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"Appendix B: Preliminary Letter Report." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"Appendix B: Preliminary Letter Report." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"Appendix B: Preliminary Letter Report." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"Appendix B: Preliminary Letter Report." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"Appendix B: Preliminary Letter Report." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"Appendix B: Preliminary Letter Report." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"Appendix B: Preliminary Letter Report." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"Appendix B: Preliminary Letter Report." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"Appendix B: Preliminary Letter Report." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Suggested Citation:"Appendix B: Preliminary Letter Report." National Research Council. 2010. Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13031.
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Appendix B Preliminary Letter Report1 1 The report that follows is the exact text of the Preliminary Letter Report provided on a privileged basis to DHS on March 26, 2010. 77

EVALUATION OF THE NBAF SITE-SPECIFIC RISK ASSESSMENT 78

APPENDIX B 79 Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas: Preliminary Letter Report Committee on the Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security’s Planned 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 THE NATIONAL ACADEMIES PRESS Washington, D.C. w ww.nap.edu

EVALUATION OF THE NBAF SITE-SPECIFIC RISK ASSESSMENT 80 THE NATIONAL ACADEMIES PRESS 500 Fifth Street, N.W. 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 No. HSFLBP-10-C-00001 between the National Academy of Sciences and the U.S. Department of Homeland 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. Additional copies of this report are available from the National Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu Copyright 2010 by the National Academy of Sciences. All rights reserved. Printed in the United States of America

APPENDIX B 81 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

EVALUATION OF THE NBAF SITE-SPECIFIC RISK ASSESSMENT 82 .

APPENDIX B 83 COMMITTEE ON THE EVALUATION OF A SITE-SPECIFIC RISK ASSESSMENT FOR THE DEPARTMENT OF HOMELAND SECURITY’S PLANNED NATIONAL BIO- AND AGRO-DEFENSE FACILITY IN MANHATTAN, KANSAS RONALD M. ATLAS (Chair), Professor of Biology and Public Health and Co-director, Center for Health Preparedness, University of Louisville, Louisville, KY THOMAS W. ARMSTRONG, Principal Investigator, TWA8HR Occupational Hygiene Consulting, LLC, Branchburg, NJ MICHAEL S. ASCHER, Visiting Researcher, University of California, Davis MARK T. HERNANDEZ, Professor of Environmental Engineering, University of Colorado at Boulder, Boulder, CO BARBARA JOHNSON, Consultant for Biosafety and Biosecurity, Johnson & Associates, LLC, Herndon, VA BRENDAN MCCLUSKEY, Executive Director, University of Medicine and Dentistry of New Jersey, Newark, NJ KISHOR C. MEHTA, P.W. Horn Professor of Civil Engineering, Texas Technical University, Lubbock, TX FREDERICK A. MURPHY, Professor of Pathology, University of Texas Medical Branch at Galveston, Galveston, TX PHILIP L. PAARLBERG, Professor of Agricultural Economics, Purdue University, West Lafayette, Indiana TIMOTHY C. RELUGA, Assistant Professor of Mathematics, Pennsylvania State University, University Park, PA JAMES A. ROTH, Clarence Hartley Covault Distinguished Professor, Iowa State University, Ames, IA MARK C. THURMOND, Professor Emeritus, University of California, Davis, CA STAFF PEGGY TSAI, Study Director and Program Officer CARL-GUSTAV ANDERSON, 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

EVALUATION OF THE NBAF SITE-SPECIFIC RISK ASSESSMENT 84 BOARD ON LIFE SCIENCES KEITH R. YAMAMOTO (Chair), University of California, San Francisco, CA ANN M. ARVIN, Stanford University School of Medicine, Stanford, 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 D. FITZSIMMONS, John D. and Catherine T. MacArthur Foundation, Chicago, IL DAVID R. FRANZ, Midwest Research Institute, Frederick, MD LOUIS J. GROSS, University of Tennessee, Knoxville, TN JO HANDELSMAN, Yale University, New Haven, CN CATO T. LAURENCIN, University of Connecticut Health Center, Farmington, CN JONATHAN D. MORENO, University of Pennsylvania, Philadelphia, PA ROBERT M. NEREM, Georgia Institute of Technology, Atlanta, GA CAMILLE PARMESAN, University of Texas, Austin, TX MURIEL E. POSTON, Skidmore College, Saratoga Springs, NY ALISON G. POWER, Cornell University, Ithaca, NY 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, 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

APPENDIX B 85 BOARD ON AGRICULTURE AND NATURAL RESOURCES NORMAN R. SCOTT (Chair), Cornell University, Ithaca, NY PEGGY F. BARLETT, Emory University, Atlanta, GA ROGER N. BEACHY, Donald Danforth Plant Science Center, St. Louis, MO HAROLD L. BERGMAN, University of Wyoming, Laramie, WY RICHARD A. DIXON, 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, Minnesota Department of Agriculture, St. Paul, MN KIRK C. KLASING, University of California, Davis, CA VICTOR L. LECHTENBERG, Purdue University, West Lafayette, IN PHILIP E. NELSON, Purdue University, West Lafayette, IN ROBERT PAARLBERG, Wellesley College, Watertown, MA KEITH PITTS, Marrone Bio Innovations, Davis, CA CHARLES W. RICE, Kansas State University, Manhattan, KS HAL SALWASSER, Oregon State University, Corvallis, OR PEDRO A. SANCHEZ, The Earth Institute, Columbia University, Palisades, NY ROGER A. SEDJO, Resources for the Future, Washington, DC KATHLEEN SEGERSON, University of Connecticut, Storrs, CN MERCEDES VÁZQUEZ-AÑÓN, Novus International, Inc., St. Charles, MO STAFF ROBIN A. SCHOEN, Director KAREN L. IMHOF, Administrative Assistant AUSTIN J. LEWIS, Senior Program Officer EVONNE P.Y. TANG, Senior Program Officer PEGGY TSAI, Program Officer CAMILLA YANDOC ABLES, Associate Program Officer KARA N. LANEY, Associate Program Officer RUTH S. ARIETI, Research Associate JANET M. MULLIGAN, Research Associate KAMWETI MUTU, Research Associate ERIN P. MULCAHY, Senior Program Assistant

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APPENDIX B 87 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: Corrie Brown, University of Georgia, Athens, GA Philip Hagan, Georgetown University, Washington, DC Peter B. Jahrling, National Institutes of Health, Frederick, MD Jonathan Richmond, Jonathan Richmond & Associates, Southport, NC Daniel L. Rock, University of Illinois at Urbana-Champaign, Urbana, IL Gary Smith, University of Pennsylvania, Philadelphia, PA Akula Venkatram, University of California, Riverside, CA Ronald H. White, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD Alex Winter-Nelson, University of Illinois at Urbana-Champaign, Urbana, IL 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 Roger Kasperson, Clark University, and Harley Moon, Iowa State University. 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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APPENDIX B 89 CONTENTS LETTER FROM CHAIR .......................................................................................................................... 91 SUMMARY................................................................................................................................................. 93 INTRODUCTION ...................................................................................................................................... 93 SELECTION OF A SITE FOR THE NATIONAL BIO- AND AGRO-DEFENSE FACILITY AND THE ENVIRONMENTAL IMPACT STATEMENT ............................................................................. 94 CHARGE TO THE COMMITTEE.......................................................................................................... 95 CONGRESSIONAL MANDATE AND STATEMENT OF TASK............................................................................ 95 LIMITATIONS OF THE SCOPE ...................................................................................................................... 96 GENERAL OBSERVATIONS ABOUT THE DEPARTMENT OF HOMELAND SECURITY WORK PLAN ............................................................................................................................................. 96 PATHWAYS ................................................................................................................................................ 97 PATHOGENS AND HOSTS............................................................................................................................ 97 PRACTICES ................................................................................................................................................ 99 MITIGATION STRATEGIES .......................................................................................................................... 99 EXPERTISE............................................................................................................................................... 100 SITE-SPECIFIC ANALYSIS ........................................................................................................................ 100 RESPONSES TO SPECIFIC QUESTIONS POSED TO THE COMMITTEE ABOUT THE DEPARTMENT OF HOMELAND SECURITY WORK PLAN......................................................... 100 SCENARIO DEVELOPMENT ....................................................................................................................... 100 PLUME MODELING .................................................................................................................................. 102 PROSPECTIVE EPIDEMIOLOGICAL STUDY ................................................................................................ 106 ECONOMIC STUDY ................................................................................................................................... 110 FINAL REPORT......................................................................................................................................... 114 RIFT VALLEY FEVER AMENDMENT ......................................................................................................... 115 REFERENCES ......................................................................................................................................... 117 APPENDIXES 1 COMMITTEE’S REVISIONS TO DRAFT FINAL REPORT OUTLINE .......................................................... 123

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APPENDIX B 91 Board on Life Sciences 500 Fifth Street, NW Board on Agriculture and Natural Resources Washington, DC 20001 Phone: 202 334 2215 Fax: 202 334 1289 E-mail: bls@nas.edu March 26, 2010 Mr. James V. Johnson Director, Office of National Laboratories U.S. Department of Homeland Security Science & Technology Directorate Washington, DC 20528 Dear Mr. Johnson: At the request of the U.S. Congress and the Department of Homeland Security (DHS), the National Research Council’s Division on Earth and Life Studies established the ad hoc Committee on the Evaluation of the Site-Specific Risk Assessment for the Planned National Bio and Agro-Defense Facility (NBAF) in Manhattan, Kansas. The committee’s charge was to provide comment on the work plan for a risk assessment for the NBAF that is specific to Manhattan, Kansas location. The committee held an in-person meeting on February 26, 2010. At the meeting, DHS staff and contractors presented their proposed approach for the risk assessment, asked the committee for specific advice on the work plan, and answered questions raised by committee members. The committee met in closed session to deliberate and draft a response to the proposed work. This interim letter report contains the committee’s responses to advise the DHS work plan for the site-specific risk assessment of the NBAF. The report contains several recommendations for consideration by the agency as it develops a more robust work plan and conducts its risk assessment for a new high-containment foreign animal disease laboratory. On behalf of the committee, we look forward to the final report of the site specific risk assessment in June 2010 and to providing a review of that effort. Sincerely, Ronald M. Atlas, Chair COMMITTEE ON THE EVALUATION OF THE SITE-SPECIFIC RISK ASSESSMENT FOR THE PLANNED NATIONAL BIO AND AGRO-DEFENSE FACILITY IN MANHATTAN, KANSAS

EVALUATION OF THE NBAF SITE-SPECIFIC RISK ASSESSMENT 92

APPENDIX B 93 SUMMARY The committee reviewed the U.S. Department of Homeland Security (DHS) work plan for the site-specific risk assessment (SSRA) of its planned National Bio- and Agro-Defense Facility (NBAF) in Manhattan, Kansas. The committee believes that the proposed work plan provides a reasonable framework but misses several fundamental issues related to the Manhattan site and the unique requirements of a foreign animal and zoonotic disease facility. The SSRA does not appropriately analyze potential pathways and will need to consider a better balance of other possible pathways of pathogen escape including, but not limited to, wastewater, fomites and residual solid wastes. The committee is concerned about the SSRA being limited to an examination of foot-and-mouth disease (FMD) and Rift Valley fever (RVF) viruses. The SSRA will need to take into account the range of risk posed by working with the comprehensive suite of pathogens that are likely to be in the NBAF, including those at the BSL-4 level. FMD and RVF viruses do not represent the array of infectivity, vectors, hosts, environmental factors, and maximum credible risk scenarios that may result from emerging pathogens with unknown characteristics that require attention in the proposed high-containment facility. The SSRA does not take into account the necessary laboratory training or management practices for establishing a competent, experienced, and credentialed workforce. Mitigation strategies are not robustly or precisely addressed and will need to include other federal, state, county, and local officials to develop preparedness and response plans. Determining the economic effects of an outbreak will require the SSRA to go beyond local market effects and include a national and international assessment that addresses additional commodities that would be affected by an outbreak. Finally, to provide a more comprehensive and thorough SSRA, DHS and its contractors will need to consult additional subject matter experts to examine all the risk factors that need to be considered. INTRODUCTION In its 2002 report Countering Agricultural Bioterrorism, a National Research Council committee identified gaps in knowledge about foreign-animal pathogens that reduced the reliability and timeliness of risk-assessment and risk-management decisions, and it determined that the ability to detect and identify some animal pathogens rapidly after introduction was inadequate (NRC, 2002). After the creation of the Department of Homeland Security (DHS), that issue was partly addressed by Homeland Security Presidential Directive 9 (HSPD-9), Defense of United States Agriculture and Food, which directs the secretary of agriculture and the secretary of homeland security to “develop a plan to provide safe, secure, and state-of-the-art agriculture biocontainment laboratories that research and develop diagnostic capabilities for foreign animal and zoonotic diseases”. To meet its obligations under HSPD-9, DHS plans to construct and operate a new facility—the National Bio- and Agro-Defense Facility (NBAF)—that, when fully operational, will replace the Plum Island Animal Disease Center (“Plum Island”). DHS has determined that Plum Island is nearing the end of its design life and lacks critical capabilities, including a modern BSL-41 laboratory, to continue serving effectively as the primary facility for 1 Biosafety Level 4 (BSL-4) is the highest possible level of containment. BSL-4 laboratories are “required for work with dangerous and exotic agents that pose a high individual risk [in humans] of life-threatening disease, aerosol transmission, or related agent with unknown risk of transmission” for which vaccines or other treatments are not

EVALUATION OF THE NBAF SITE-SPECIFIC RISK ASSESSMENT 94 research on foreign animal diseases, including zoonotic diseases. DHS also believes that Plum Island's remote location prevents effective collaboration with academic scientists. The NBAF is envisioned as a state-of-the-art BSL-3-Ag and BSL-4 laboratory that will be capable of performing research on foreign animal and zoonotic diseases, providing a teaching facility for the recognition and management of these diseases, and providing the capability for diagnosing the highest foreign animal disease threat. One of the most serious foreign animal disease threats is foot-and-mouth disease (FMD), a disease caused by a nonhuman pathogen. FMD virus (FMDv) is easy to acquire and transmit among cattle, small ruminants, and swine; its ability to spread to limited but high-economic-value hosts poses a unique problem. Another is Rift Valley fever (RVF), which is caused by a viral zoonotic pathogen that mainly affects animals and results in substantial economic losses but also may cause severe disease in humans (BuaNews, 2010). In evaluating the risks posed by the selected site in Manhattan, Kansas, there is a need to include comparative analysis to distinguish site-specific components of risk from general components of risk that would be present at other sites. The research agenda for the new NBAF is still unknown, but it is expected that essential and cutting-edge research will be conducted there. Such research could include synthetic biology, molecular ecology, genetic engineering, aerosol infectivity studies in BSL-3-Ag, and work with unknown or uncharacterized pathogens that may infect humans or cause latent infection in humans or animals. The NBAF is expected to permit work with large animals in a BSL-4 laboratory—a new capability that has not existed in the United States and that will carry its own unique set of risks (some which may be new) that will need to be taken into account in the site-specific risk assessment (SSRA). The NBAF research agenda will define the types of pathogens studied and the risks that they pose. It is possible to identify and mitigate risks associated with infected animals on the basis of existing knowledge, but what remains unknown is the magnitude of risk and the strategy or process flow to identify and mitigate risk in future research areas. The SSRA will need to include contingency plans that minimize risk and mitigate maximum credible risk scenarios that could result from inadvertent or deliberate release of foreign animal or zoonotic disease agents from the facility. SELECTION OF A SITE FOR THE NATIONAL BIO- AND AGRO-DEFENSE FACILITY AND THE ENVIRONMENTAL IMPACT STATEMENT DHS began a site-selection process for the NBAF in January 2006 and eventually selected six sites (Plum Island and five new ones) to be evaluated in an environmental impact statement (EIS). During the preparation of the EIS, DHS used Gaussian plume modeling to model the extent of FMDv dispersion in seven accident scenarios and one scenario reflecting intentional disruption for the six sites in the competition (DHS, 2008). It also analyzed the potential economic impact of an FMDv release at each of the sites. A threat risk assessment (TRA) was developed independently of the EIS to identify and evaluate potential security risks, such as crimes against people and property and threats associated with compromised or disgruntled employees. The final EIS, issued in December 2008, identified the Kansas State University (KSU) campus in Manhattan, Kansas, as the preferred site. After consideration of the TRA and the EIS, DHS formally selected a site for the NBAF in January 2009 (Federal Register, available (HHS, 2007). The BSL-4 portion of the planned NBAF will be designed to handle zoonotic pathogens, such as Nipah and Hendra viruses, with capabilities for large animal research.

APPENDIX B 95 2009). On selection of the Manhattan site, DHS planned to conduct a site-specific biosafety and biosecurity mitigation risk assessment (SSRA) to determine the requisite design and engineering controls for the NBAF; inform the development of emergency response plans with city, regional, and state officials in the event after an accidental release of a pathogen; and assist in the development of the operational protocols needed to operate the facility safely and securely. Prior to the initiation of the planned SSRA, the Government Accountability Office (GAO) raised concerns in their July 2009 report about DHS's analyses of the risk related to performing FMD research on the U.S. mainland. The analyses were developed as a component of the earlier NBAF site-selection process. GAO faulted DHS's choice of the plume model, noting that the one used had not been validated for biological materials, and added many detailed criticisms. GAO found that DHS's economic analysis was flawed in that it focused only on the impacts of a ban on livestock exports and did not address domestic market impacts. GAO also stated that DHS did not effectively integrate the critical information from its analyses to characterize the differences in risks between mainland and island sites. CHARGE TO THE COMMITTEE Congressional Mandate and Statement of Task The FY 2010 DHS Appropriation Act (P.L. 111-83) directed DHS to undertake the planned SSRA of the proposed NBAF in Manhattan, Kansas prior to the obligation of construction funds. The legislation instructed DHS to work with the National Research Council to evaluate the risk assessment and provided the statement of task shown in Box 1. Box 1 Statement of Task In reaction to criticism from the Government Accountability Office (GAO), the FY 2010 DHS Appropriation Act (P.L. 111-83) prohibits the obligation of funds for construction of the new National Bio- and Agro-Defense Facility (NBAF) until the Secretary of Homeland Security undertakes a site-specific biosafety and biosecurity mitigation risk assessment for the Manhattan, Kansas site. Once DHS completes the risk assessment, the Congressional language mandates that the National Academy of Sciences (NAS) provide an independent evaluation of the DHS analyses. Therefore, under the auspices of the Board on Life Sciences and the Board on Agriculture and Natural Resources, the National Research Council will convene a committee of experts to review the DHS site-specific risk assessment. The committee will not perform an independent evaluation of the safety of the NBAF, but will restrict its findings to assessing the adequacy and validity of the site-specific risk assessment. DHS is currently conducting a source selection process for a contractor to manage the development of the risk assessment. Subsequent to the selection, the committee will undertake its first task to answer questions related to the selected contractor's work plan brought to it by DHS. In this capacity, prior to the contractor beginning their modeling and risk assessment process early in 2010, the NAS Risk Assessment Committee will meet with DHS in order to review the contractor’s Work Plan for the Risk Assessment and answer questions from DHS related to the plan. The NAS Risk Assessment Committee will convene to review the contractor’s Work Plan

EVALUATION OF THE NBAF SITE-SPECIFIC RISK ASSESSMENT 96 and the questions provided by DHS and will provide a brief letter report to DHS in response to these questions within four weeks of this meeting. This brief letter report will not be available to the public until the second letter report of the NAS Risk Assessment Committee, described below, is available to the public. Following the delivery of the final Risk Assessment report by the performer to DHS, the committee will undertake its second task to review the finished site specific risk assessment and prepare a second and final letter report containing its findings within four months of receiving the performer’s report from DHS. The National Research Council convened a committee of experts (see Appendix A) to evaluate the SSRA of the planned NBAF in Manhattan, Kansas. In preparation for the SSRA, DHS and its contractors submitted a draft work plan for the committee to review and provided 28 written questions related to the work plan for the committee to address. The committee held its first meeting on February 25–26, 2010, in Washington, D.C. to discuss the work plan with DHS and its contractors (see Appendix C for meeting agenda). In attendance to provide presentations and clarifications about the NBAF and the SSRA were DHS and U.S. Department of Agriculture (USDA) representatives, contractors preparing the SSRA, and many subject matter experts retained by the contractors. The committee then met in closed session to evaluate the SSRA work plan and to discuss the questions raised by DHS for committee consideration. This preliminary interim letter report reflects the proposed SSRA work plan and the committee’s discussions of the risk-assessment methodology. Limitations of the Scope In this preliminary letter report, the committee is charged with providing comments on the DHS SSRA work plan. It is not charged with comparing Manhattan, Kansas, with other possible sites. DHS conducted an EIS to provide a comparative analysis of six possible sites (DHS, 2008) and has already selected Manhattan (Federal Register, 2009). The SSRA differs from the EIS in that this risk assessment will provide a more detailed analysis of the risks, impacts, and mitigation strategies related to the Manhattan site and thus will provide finer granularity than the EIS. The SSRA is not aimed at judging whether the selection of the Manhattan site was appropriate for locating the NBAF. Instead, it will focus on the specific risks associated with the facility in Manhattan when the NBAF is constructed, on how those risks can best be mitigated (through construction design, personnel training, and laboratory protocols), and on plans for containment to minimize an impact if there is a release of a pathogen from the laboratory. The committee’s task in the second letter report will be to evaluate whether DHS has conducted an adequate and credible risk assessment of the Manhattan site. It is not in the committee’s purview to interpret that assessment or to make site determinations for NBAF. GENERAL OBSERVATIONS ABOUT THE DEPARTMENT OF HOMELAND SECURITY WORK PLAN Without design documents and specifications, it is difficult to develop an accurate SSRA and difficult for the committee to conduct a review with confidence that the risks have been

APPENDIX B 97 mitigated in whole or in part by engineering and appropriate infrastructure. Nevertheless, the committee reviewed the work plan and had several overall concerns about how it was framed. Pathways A major emphasis of the planned SSRA has been on FMDv aerosol release and plume analyses. The committee could not discern whether the aerosol release model included consideration of nearby aerosol settling—and thus deposition on crops, grazing land, other surfaces, or animal skin—or considered only inhalation of aerosol. There are models to support the hypothesis of windborne transmission of FMDv (Gloster et al., 2005b), but previous FMDv releases provide evidence that long-distance airborne transmission may not be the main route of exposure (HSE, 2007) and that animals may be less likely to become infected through inhalation than through routes consistent with direct or indirect exposure. The SSRA is not balanced with respect to efforts to analyze aerosol pathways compared with other potential pathways of pathogen escape. The committee recommends that the SSRA examine the release scenarios according to four categories of pathogen transport: (1) in air, (2) in solid waste, (3) in liquid waste and sanitary wastewater, and (4) in or on fomites or hosts, including workers, equipment, vectors, and dead or living animals (NRC, 2010). The scale of the facility will present substantial sanitary engineering challenges for the safe handling and disposal of large volumes of waste—particularly wastewater and biosolids, such as feces, food, vomit, cud, fur, skin, and other animal parts—generated by its mission to handle large animals. The committee is concerned that critical aspects of sanitary residuals management have not been given appropriate attention. In the context of the SSRA, the committee recommends that additional emphasis be placed on the infrastructure for handling liquid and solid waste, the engineering design basis for management of wastewater and biosolids, and the terminal disposal plans for all residuals, including quantitative estimates. Pathogens and Hosts The committee is concerned about limiting the SSRA to FMD and RVF viruses. It is not clear that those two agents adequately represent the range of mechanisms of infection, vector involvement, and differences in receptors, hosts, and environmental factors likely to be present in the array of organisms to be studied at NBAF. Furthermore, FMD and RVF may not represent the maximum credible risk scenarios that may result from an emerging or unknown pathogen that may be studied in the NBAF. DHS has indicated that the NBAF will initially work with the pathogens that cause eight diseases: FMD, classical swine fever, African swine fever, RVF, contagious bovine pleuro pneumonia, Japanese encephalitis, Nipah virus infection, and Hendra virus infection. The list of foreign animal diseases extends beyond the eight listed in the work plan; because the NBAF will be designed as a foreign animal and zoonotic disease research facility, additional foreign animal and zoonotic disease pathogens will need to be factored into the risk assessment. Whereas the full portfolio of pathogens need not be included in this SSRA, the SSRA should be broadened to consider the characteristics of all eight pathogens and other foreign animal and zoonotic disease pathogens and to address the types of unknown or emerging pathogens that the NBAF may study

EVALUATION OF THE NBAF SITE-SPECIFIC RISK ASSESSMENT 98 in the future. A systematic enumeration of characteristics of the laboratory pathogens portfolio should be developed as part of the SSRA. This analysis should be based on a rigorous assessment and evaluation of primary scientific literature. Consideration should also be given to endemic animal diseases that are zoonotic and will have high priority for research at the NBAF and to the potential for pathogens to establish an endemic level of infection in wildlife. The SSRA should then focus on assessing the maximum credible risk scenarios related to the pathogens, including the potential impact and mitigation strategies for each scenario. The plan for the SSRA focuses almost exclusively on BSL-3-Ag issues. FMDv is highly infectious and has great economic impact, but it is not a zoonotic agent or a BSL-4 threat. The SSRA will need to take into account the risk posed by working with a BSL-3-Ag or BSL-4 pathogen that requires special handling in the NBAF. Given that the NBAF plans include a BSL- 4 laboratory with animal handling capability for large animal research, the SSRA should consider the risks related to a BSL-4 zoonotic agent that has broader host ranges than FMDv, such as Nipah or Hendra viruses or other pathogens that may be worked on in the NBAF’s BSL- 4 facility. The initial plan of using FMD and RVF viruses to “bracket” the severest outcomes is a reasonable start. However, biological systems are complex, and results obtained with one organism cannot necessarily be generalized to other organisms to the same extent as results in physical systems. The facility will be designed to handle BSL-4 zoonotic agents and it is likely that the laboratory will be used to the fullest extent of its design capabilities. Because of the diversity and complexity of biological systems, it is important to consider each pathogen and agent studied in the laboratory as an independent source of risk. A systematic enumeration of the characteristics of the laboratory pathogen portfolio would help identify potential risks peculiar to each pathogen. In particular, these risks may depend on the specifics of the laboratory site. In addition, such an enumeration would highlight where scientific knowledge is incomplete or uncertain so that risk-mitigation plans do not confuse uncertain risks with low risks. In addition to known pathogens, it is reasonable to expect this laboratory to work with any emerging animal pathogens with unknown characteristics. It is important that facilities be prepared to handle risks associated with such pathogens, and that the risk assessment be sufficiently broad to address potential challenges in handling such a pathogen. However, consideration of uncharacterized emerging pathogens should be constrained to reasonably foreseeable site-specific risks and not engage in whimsical speculation. Practices Laboratory training and management practices will be vital in establishing a culture of biosafety and biosecurity among NBAF personnel. Those practices cannot be addressed adequately or reliably measured in a quantitative risk assessment, because they depend critically on the characteristics and ethics of laboratory personnel. Nevertheless, human factors such as training and management practices should be highlighted as critical determinants of risk. Initial and on-going training2 is a major component of the risk preparation and mitigation process in 2 Training is a broad term and can range from reading standard operating procedures and viewing Powerpoint presentations to having book knowledge and observing correct techniques. Training could also include a mentoring program where individuals, regardless of experience, would need to demonstrate competency while performing tasks in the laboratory. In some contexts, training is a “one time” process (such as an introduction to biosafety levels), while in other cases it may be annual refresher courses (such as courses on blood-borne pathogens and use

APPENDIX B 99 support of developing and maintaining an effective culture of biosafety and biosecurity among facilities personnel. The NBAF approach and commitment to training and resources should be included and described in the work plan and SSRA. The NBAF management and program will need to address how they will be able to instill and support the development of core values— bioethics, personnel reliability, and accountability—and view biosafety and biosecurity not merely as regulatory functions but as an essential part of personal and collective commitments (NRC, 2009). The challenges of attracting or developing a competent, experienced, and credentialed workforce for opening a new BSL-3-Ag and BSL-4 biocontainment facility at the Manhattan site should be addressed in the SSRA. The SSRA will also need to address mitigation of risks associated with an influx of academicians and their staff into the laboratory, which was one of DHS’s justifications for locating the NBAF close to a research university. It would be useful for the SSRA to consider the risks associated with the lack of respiratory protection for workers that come into contact with FMDv. It is a common recommendation that workers exposed to FMDv-infected animals not contact other susceptible animals for 5 days—as a result of studies demonstrating recovery of virus from nasal passages (Sellers et al., 1970, 1971)—to reduce the risk of respiratory transmission. While the committee is not aware of literature showing this as an important route of transmission, the SSRA should be thorough and also address the risk of transmission to cattle in the Manhattan, Kansas area due to the contamination of respiratory tracts of workers. Mitigation Strategies The work plan will need to address the mitigation strategy more robustly and more precisely than indicated in the plan for the SSRA. Cross-contamination between animals or cultures—for example, contamination of the severe acute respiratory syndrome coronavirus in a West Nile virus culture—is not uncommon (WHO, 2003), and mitigation of this type of event should be addressed. When developing mitigation, preparedness, response, and recovery plans, the mitigation strategy will also have to specifically outline the roles of DHS, USDA, and local, county, state, university, and other relevant officials throughout the project. The mitigation plan will need to address risks that are specific to the laboratory in Manhattan, Kansas, including its high density of livestock in the U.S. livestock belt, its location as a hub of livestock transportation systems that rapidly moves animals and animal products nationwide, and any risks associated with proximity to or collaboration with a university. To understand the planned response to an FMD outbreak in the Manhattan, Kansas region, the SSRA should consult with USDA about their FMD preparedness and response plan and their draft beef cattle feedlot facility manual. Access to those draft documents can be provided by the USDA Animal and Plant Health Inspection System (APHIS) Veterinary Services (VS) National Center for Animal Health Emergency Management. The current work plan lacks a critical component of risk communication (Reynolds, 2008) as a part of the risk-management strategy. A good risk communication strategy will need to address qualitative and quantitative risks. The public perception of risk will be influenced by the communication strategy, thus a good strategy may need to use lay language and concepts in of respirators) (29 CFR Parts 1910-134 and 1910-1030). When performance is critical, refresher training or competency will need to be demonstrated periodically, and the testing of learned knowledge and skills is a critical part of the training continuum.

EVALUATION OF THE NBAF SITE-SPECIFIC RISK ASSESSMENT 100 relation to levels of risks that the general public can understand and to which they can relate, without using condescending or overly technical terms. Many of the good practices in risk communication are laid out in several sources (NRC, 1989; Sandman, 1990; Peters et al., 1997; Covello et al., 2001; CDC, 2002). These good practices and lessons from other high- containment facilities to distinguish between effective and ineffective risk communication should be applied to the NBAF SSRA (NRC, 2007, 2008, 2010). Expertise The committee reviewed the expertise of the DHS contractors and subject matter experts that will assist with the SSRA. The committee found that the following supplemental subject matter experts are needed: • A sanitary and residuals engineer to address the specific pathways of pathogen entry or escape in liquid waste, wastewater, biosolids, and solid waste; • A veterinarian who has direct laboratory and animal containment experience with FMDv, specifically in both diagnostic and research settings; • An emergency preparedness and mitigation strategy expert who has experience in local, state, and national emergency management and response; and • A risk communications expert familiar with the types of risks posed by a high- containment facility. Site-Specific Analysis The committee believes it is important to include a clear and acceptable description and treatment in the models of this site-specific risk assessment for how the geographical location of Manhattan, Kansas could affect or influence potential spread and mitigation of a disease like FMD throughout the United States. RESPONSES TO SPECIFIC QUESTIONS POSED TO THE COMMITTEE ABOUT THE DEPARTMENT OF HOMELAND SECURITY WORK PLAN Scenario Development Question 1.1: Accidental scenario selection: Do these eleven accidental release scenarios sufficiently describe the range of accidental releases that adequately bound the initial conditions for plume modeling, prospective epidemiological modeling, and economic impact assessments for the Site-Specific Risk Assessment (SSRA)? Response to 1.1: As mentioned above, the committee recommends that the release scenarios be reorganized into four main categories that correspond to fundamental paths or media for pathogen transport: (1) in air, (2) in solid waste, (3) in liquid waste and sanitary wastewater, and (4) in or on fomites or hosts, including workers, equipment, vectors, and dead or living animals. Critical path release analyses for each of the fundamental paths should include

APPENDIX B 101 facility engineering, personnel reliability, and operational considerations. Catastrophic events that result in multiple simultaneous avenues of release should also be considered. The committee also sees the facility as broader than just the physical place: transport of samples, the conveyances coming to the laboratory, and other activities related to the presence of the facility need to be considered. That broader context of risks associated with the facility should be considered in the SSRA. Question 1.2. Deliberate scenario selection: Do these two deliberate/intentional release scenarios adequately represent the range of deliberate/intentional acts with enough fidelity to meet or exceed the expectations of the SSRA? Response to 1.2: For each of the two scenarios, it would be necessary to consider insider, outsider, and coincident3 threats in the vicinity (NRC, 2010). Question 1.3. Scenario recommendations: Other than responses to previous questions, are there other accidental or deliberate scenarios or categories of scenarios that should be considered in this SSRA? Response to 1.3: Many scenarios on the input side could be considered, but the fundamental scenarios have already been listed in the work plan. The committee believes that the risk assessment should include a transportation-specific scenario that considers the time and any risks related to transporting pathogens, for example, between the Kansas City airport and the Manhattan facility. The committee is also concerned about whether a competent workforce (from laboratorians and support staff to researchers) will be in place on day 1; the work plan should address the reality of initial start-up and personnel concerns related to operating the NBAF in Manhattan, including the transition to fully operational status and under what conditions academicians and their staff will be allowed to begin work. It was unclear whether the work plan considered already established hazard identifications and risk assessments completed by KSU for Manhattan and the surrounding county, where some assessments dealt with similar risks but others addressed different risks. The work plan should address engaging the municipal, county, state, and university emergency management organizations; using their expertise; and considering the hazards, vulnerabilities, and risks previously identified by these entities. Question 1.4. Approach to the development of scenarios: Will this approach to developing scenarios meet the stated purpose of the SSRA? Response to 1.4: No. Scenario development currently excludes local responders in their mitigation strategies and responses. For an entity to be registered with USDA to work with, possess, or transfer select agents, federal law requires it to address planning and coordination with local emergency responders in its incident response plan (7 CFR Part 331). Local responders are critical components in mitigating and responding to threats, and need to be included in developing the scenarios. 3 Coincident threat is defined as a threat that becomes more probable because of a coincidental series of events (such as an occurrence with the infrastructure, procedures, or weather). For example, if there were a fire in the facility and the door locks were automatically disabled as part of life-safety requirements to facilitate emergency egress, could malevolent outsiders or insiders gain access to materials, animals, or other assets during the confusion of evacuation that they would normally not be able to access?

EVALUATION OF THE NBAF SITE-SPECIFIC RISK ASSESSMENT 102 Signature Science, the contractor carrying out the risk assessment, noted its plans to conduct physical and virtual site visits of comparable biocontainment facilities in Geelong, Australia; Pirbright, UK; and Winnipeg, Canada. The committee agrees that it is prudent to glean best practices and lessons learned from those facilities. However, there are questions about whether the benchmarks for the other facilities will be applicable to the Manhattan site in light of site variables such as density of humans and animals (including livestock and wildlife), local climate, and infrastructure (for example, transportation and healthcare systems). One unique aspect of the Manhattan site is the high density of livestock in the vicinity of the laboratory. The other high-containment facilities also differ in practices that may not apply to the NBAF. The Pirbright facility is aging and has infrastructure and engineering shortcomings that do not equate to the anticipated state-of-the-art design plans for the NBAF. The Geelong facility was constructed on the mainland in 1985; it does not conduct FMD research on site but instead contracts FMD research to foreign facilities (GAO, 2008). The Winnipeg facility is modern but can work with only two infected cattle at a time (GAO, 2009), whereas the NBAF potentially could work with 100 at a time. Signature Science should also consider seeking out accepted practices and lessons learned from other BSL-3, BSL-3-Ag, and BSL-4 facilities in the United States (such as the University of Texas Medical Branch at Galveston, the U.S. Army Medical Research Institute for Infection Diseases, and the Centers for Disease Control and Prevention) and abroad. Plume Modeling Question 2.1. Climatological datasets: Are there any other available climatological datasets that the NAS Committee would consider more appropriate for meeting the goals of this SSRA? Response to 2.1: The committee believes the subject matter expert consultants from the National Center for Atmospheric Research listed as part of the SSRA team have the relevant expertise to recommend the appropriate climatological dataset; however, there is concern about the spatial resolution of this dataset. Whereas the climatological dataset described here may provide the best means of identifying relevant meteorological phenomena for the risk assessment, plume models of aerosol releases need to be applied on much finer time and space scales to resolve infection events. Patterns of variation may differ between the fine grid needed for plume models and the coarse grid used by climate data. The risk assessment should do as well as it can in controlling for variation among spatial scales and communicating the extent of uncertainty created by the variation. The SSRA should also explain why the puff model was chosen over other airborne-FMDv models (Gloster et al., 2010). Question 2.2. Estimate for range of FMDv spread: Does the NAS agree/disagree with the proposed range? If NAS disagrees, what upper bound on range or parameters to determine range, would NAS recommend? Note that that this value will be used to define our computational spatial domain limits. Responses to 2.2: There is a lack of reliable data on the parameter of FMDv’s airborne transmission range and thus there is no foundation that the committee has identified in the literature for the proposed 500-km range: if FMDv could be transmitted across 500 km (for example, involving farm-related outbreaks and natural aerosol transport), FMD-free zones would not exist. The committee is not aware of any published peer-reviewed literature that can provide

APPENDIX B 103 an accurate basis for acceptable upper-bound limits. A study by Gloster and colleagues (2005b) suggested that if airborne transmission took place in early outbreaks, it was limited to 60 km. The article from Sǿrensen (2003) is used as a basis for the SSRA work plan and it proposes longer-distance spread of up to 250 km, but that range is based upon hypothetical scenarios rather than experimental data; that author also noted in the 2001 UK FMD epidemic that “long- range atmospheric disease spread was highly unlikely.” The notion of possible airborne spread of FMDv was first explored retrospectively for the 1967–1968 outbreak of FMD in the UK (Hugh- Jones and Wright, 1970; Tinline, 1970). Several contemporary papers on possible FMDv transmission by wind have since been published (Sǿrensen et al., 2000, 2001; Mikkelsen et al., 2003; Alexandersen et al., 2003a; Gloster and Alexandersen, 2004; Gloster et al., 2005a,b, 2010; Garner et al., 2006; Sellers and Gloster, 2007; Schley et al., 2009) and should be reviewed both for estimates of parameters and for assessment of model types. The committee suggests that a better approach to applying the estimates is needed and recommends that the SSRA ask fundamental questions about the distribution, density, and distance of susceptible animal populations around the facility. The distance to the closest susceptible animals is more critical than the maximum distance of spread through the plume model. The committee believes that cattle in near-range of the facility are likely to facilitate quicker and more distant spread of FMDv than aerosol transmission because of the various ways cattle are transported across the region and country. Therefore those transportation modes will become more relevant factors in determining the extent of disease spread, and the length of aerosol plume will become largely irrelevant. There are several reasons for placing a more realistic and lower weight on possible windborne transmission of FMDv. A basic and critical flaw in the thinking and logical premises of those advocating windborne transmission is the assumption that because most investigations have been unable to identify with absolute certainty the contacts that led to all cases, the remaining unaccounted transmission would have been airborne. All possible means of direct and indirect contact with animals and vectors (such as birds, fox, dogs, cats, and insects) that can travel considerable distances will be difficult to quantify and examine. Early studies have pointed to the major role of weather in disease spread (Gloster et al., 2005b), and recent work has provided partial support for it; in some cases the direction of spread has coincided with or correlated with wind direction (Mikkelsen et al., 2003; Gloster et al., 2005a,b; Schley et al., 2009; Gloster et al., 2010). The studies supporting the notion of airborne transmission have, at the onset, acknowledged their bias in favor of airborne transmission and have modeled correlation to support their hypothesis (Mikkelsen et al., 2003; Gloster et al., 2005a,b; Schley et al., 2009; Gloster et al., 2010). However, if one acknowledges the correlations found in some studies, it would be prudent to include (but not rely exclusively on) models of airborne transmission in any comprehensive approach to modeling of the spread of FMDv within the United States and to use appropriate sensitivity analyses that recognize that the amount of theoretical airborne transmission possible, if any, remains unknown. Inclusion of both direct-transmission and indirect-transmission models and airborne models would begin to address a maximum credible event scenario, a scenario that assumes airborne transmission is possible. Question 2.3. SSRA climatological dataset validation: Are there additional SSRA validation exercises for the climatological reanalysis dataset that the NAS would recommend?

EVALUATION OF THE NBAF SITE-SPECIFIC RISK ASSESSMENT 104 Response to 2.3: No. However, aerosol dispersal is only one of several possible modes of pathogen release from the NBAF. Recent history indicates that aerosol escape and dissemination from a laboratory that conforms to modern design and safety practices is less likely than pathogen escape through other pathways, such as waterways and fomites (HSE, 2007; GAO, 2008). Aerosol dispersal might play a role in the spread of pathogens among animals, but again it is only one of several dispersal modes and may not be the most important. Thus, the committee believes that the SSRA should initially give roughly equal weight to all potential modes of release and spread, as listed above in the four areas of general concern, and should use sensitivity analyses to assess changes in the weighting. Question 2.4. Atmospheric fields: Are there other atmospheric fields that have a considerable impact on FMDv atmospheric transport dispersion stability and deposition, which NAS would recommend be included in our self-organizing maps analysis? Response to 2.4: No. However, atmospheric deposition should be included as a critical dispersion factor in infective delivery (including its effect on the animal-feed supply). Question 2.5. Climatological data reduction techniques: What other climatological data reduction techniques would NAS recommend for consideration? Response to 2.5: None. See responses to questions 2.3 and 2.4. General parameter values used by the SSRA appear to be outdated and of little value. Several papers have published new and additional values for LD50, particle size, and other factors that should be used in place of or in addition to those in the current SSRA analysis (Gloster and Alexandersen, 2004; Gloster et al., 2007, 2008, 2010; Sellers and Gloster, 2007; Schley et al., 2009). Question 2.6. Indoor transport and dispersion models: Are there other indoor transport and dispersion models or means to estimate fire-induced temperatures and pressures that the NAS committee would consider more appropriate for this particular application? Response to 2.6: The committee believes that there should be a better explanation of the planned role of this modeling in the overall SSRA. The chosen indoor air model assumes instantaneously well-mixed air in each chamber. That will underestimate the near-field exposure to a receptor in the same chamber. In addition, plumes can occur indoors and lead to a higher rate of initial transfer to downstream chambers. If the goal is estimating transfer and infection of another indoor receptor, more complex modeling may be applicable. However, if the goal is estimating release to the outdoor environment, the proposed model may be suitable if appropriate upper-bound estimates in the concentration range are used. The committee cautions that for a risk assessment oriented toward the environment surrounding the laboratory, conservative bounds can be derived on the basis of specific scenarios without the need for much more complex approaches; furthermore, no extra certainty would be gained. Question 2.7. Exterior transport and dispersion models: Are there other exterior transport and dispersion models that should be considered over the Second-order Closure Integrated PUFF model (SCIPUFF) that may be more appropriate for this particular application? Response to 2.7: At the current time, the committee believes that SCIPUFF is an appropriate engine for the exterior-transport and dispersion modeling required by the SSRA. It is noted that SCIPUFF is accepted as one of EPA’s alternative models for non-steady-state dispersion. However, the committee is concerned that the proprietary restrictions on the Joint

APPENDIX B 105 Effects Model (JEM) platform and the associated SCIPUFF version 2.4 component will limit the transparency of the risk assessment. Without sufficient transparency, the committee found it difficult to independently review and validate whether the proposed models would be appropriate for the SSRA. The CALPUFF Modeling System is the Environmental Protection Agency’s (EPA’s) standard for non-steady-state plume dispersal. While CALPUFF uses an older approach to plume modeling, it has the advantage of being an open platform with widespread use. Other models that were not considered in the work plan but are generally accepted by those modeling FMDv aerosol transmission are also worth investigating (Mikkelsen et al., 2003; Gloster et al., 2005a,b, 2010; Schley et al., 2009). Selecting the right model for the SSRA is sufficiently complicated that the committee recommends DHS defer to the expert knowledge of its contractors for its final choice of method to simulate FMDv release plumes, with two caveats: (1) that their methods should conform to standard practice, and (2) that the methods be sufficiently open so interested parties can reasonably replicate their analysis and results. Therefore the platform chosen for the plume modeling should be an open platform to allow for independent review of the results of the risk assessment. The committee did not ascertain whether modeling results would be used only for aerosol inhalation estimates or whether they would also feed into surface contamination estimates. The work plan will need to consider other exterior transport and dispersion modes, such as a scenario that includes pathogen transmission via truck tires. Question 2.8. “Bulk” urban effects modeling: Due to the low urban density characteristics of the Manhattan area, do you agree with our proposal to model the “bulk” urban effects on the winds and turbulence? Response to 2.8: The committee agrees that it is necessary for the SSRA to examine how local meteorology might enhance risk. The SSRA will have to particularly consider tornado climatology, since Kansas is tornado-prone. Topography is not likely to be a concern in Manhattan, Kansas, though its relatively flat terrain should still be considered in the assessment. With regard to the surrounding terrain, the atmospheric boundary layer, wind speed, and turbulence will vary with height depending on surface roughness4. Technology has not yet developed where it can take into account individual buildings and trees that can make the surface of the earth seem rough—where roughness of the ground creates wind speed profiles for speed and turbulence—and it may not need to because the effects of individual buildings would not be particularly important for the boundary layer. Sensitivity analyses will be needed to specifically address “bulk” effects (presumably referring to large-scale mixing and transport phenomena), and the committee expects that aerosol dispersal models will incorporate a sensitivity analysis for a reasonable range of atmospheric mixing patterns. A suburban profile is probably better to use than an urban profile that includes large, tall buildings and the effect of their turbulence wake. The committee reiterates that plume modeling should not be central to the SSRA. 4 In engineering, terrain roughness is generally described as smooth (over water), fairly smooth (unobstructed by trees and buildings, such as an airport), rough suburban (with buildings and tress prevalent in suburban terrain), and urban with tall buildings (at the city center).

EVALUATION OF THE NBAF SITE-SPECIFIC RISK ASSESSMENT 106 Prospective Epidemiological Study Question 3.1. Parameters for FMDv release from NBAF: Does the NAS find the proposed parameters and assumptions acceptable? If not, what additional scientific evidence should be used to parameterize these qualities of FMDv? Response to 3.1: The work plan attempts to calculate precise values by using imprecise parameters, unknown and unavailable data, and an imprecise model; given the paucity of data in the United States, the questions posed by the SSRA cannot be fully addressed using the available models. The results of the calculations will undoubtedly lead to a high probability of error and consequently impart false confidence in their reliability. A more measured approach using analogies from past experiences documented in the literature may be needed to balance the modeling approach which may be overly sensitive to underlying assumptions made in the model. The North American Animal Disease Spread Model (NAADSM) and other models allow users to control the mechanisms of transmission and infection dose, but are particularly sensitive to expert opinion for the underlying assumptions and thus are vulnerable to the foibles of expert opinion. An ID15 of FMD would be catastrophic to cattle; so the use of ID506 rests on a flawed assumption. There is a need to include sensitivity analysis, and the committee recommends literature for more recent parameter estimates that have been published for dispersion models (Gloster et al., 2004, 2007, 2008, 2010; Sellers and Gloster, 2007; Schley et al., 2009). Subpoint 1: The source article referenced (Alexandersen et al., 2003b) is a review; it is not primary literature, and it does not include original or observational data. The work plan will therefore need to be revised to use original or more recent data to determine the probability of infection. A possible solution would be to discuss these data values with Pirbright scholars during the SSRA team’s planned visit to the Pirbright facility. The draft final SSRA report should include a table that lists the source of the data and the following categories: the number 5 The term “ID1” is an abbreviation for “Infectious Dose 1%,” which is the amount that can be expected to cause infection in 1% of a group. 6 The term “ID50” is an abbreviation for “Infectious Dose 50%” or “Median Infectious Dose.” The ID50 for a particular specimen of a pathogen is the amount that can be expected to cause infection in half (i.e. 50%) of a group of some particular animal species (of defined breed, genetic background, age, sex, weight, etc.), when inoculated or instilled by a particular route. In titrating an infectious agent, a series of dilutions of the test infectious material is made, and each dilution is inoculated into a set of replicate cell cultures or a small group of animals (for example, six to eight animals are often used at each dilution, spanning the expected end point). The cell cultures or animals are then observed or tested for evidence of infection and the results scored for a dilution endpoint determination. Reed and Muench (1938) and Kärber (1931) devised simple methods for estimating 50 percent dilution end points based on the total number of cell cultures or animals used in the titration, which gives the effect of using, at the two critical dilutions between which the endpoint lies, larger groups of cell cultures or animals than were actually used. These methods tend to define the dilution endpoint more narrowly than would be possible if it were simply determined by interpolation. Both the Reed-Muench and the Kärber methods are applicable primarily to complete titration series, that is, the whole reaction range, from 0 percent to 100 percent infectivity (or mortality or cytopathic effect, etc.). However, the methods have been utilized even when these conditions are not fulfilled, in some cases inappropriately. When the endpoint is mortality (of experimental animals), it is expressed as LD50 (50 percent lethal dose). ID50 indicates the dose which infects 50 percent of the test animals; TCID50 indicates the dose which infects (or gives rise to cytopathic changes) in 50 percent of inoculated tissue culture tubes/chambers/wells/etc.

APPENDIX B 107 and age of animals exposed, the method of exposure, the method of verifying the dose delivered, the strain of FMDv used, the comparative virulence of that strain and other known strains, the length of time from exposure to a declaration of infected or not infected, how infection was verified, and confidence intervals on the dose-response modeling. The committee recommends that the SSRA examine the work of Haas and colleagues (1999) because it covers many of those issues in a quantitative microbial risk assessment. Subpoint 2: The committee does not know what the infectious dose (ID) values are for wildlife, such as deer and feral swine, and believes that this information is unknown for the Manhattan, Kansas vicinity. A logical range of values that could be used would be based on published data on sheep and goats—probably the closest to wild ruminants—and on studies of FMD in domestic and feral swine. The effect of wildlife reservoirs on livestock infectivity is not known, but the possibility of establishing an endemic level of infection in wildlife that could pose a continuing threat should be considered. It will be important for the spread models to include wildlife, feral swine, and other non-domesticated susceptible species (such as those in zoos, game parks, and wildlife refuges) to ensure that the overall assessment is adequately comprehensive in addressing reasonable risks of infection and spread of FMDv. Subpoint 3: It is unacceptable to ignore subclinical cases in swine or any other species, inasmuch as subclinical infections are critical in estimating the risk of transmitting diseases to other animals. Subclinically infected pigs could be especially dangerous because they may shed virus (Alexandersen et al., 2001, 2002; Alexandersen and Donaldson, 2002) and may be moved before an infection is detected. When exposed to low doses of FMDv, pigs can develop subclinical or mild forms of disease (Kitching and Alexandersen, 2002). On a herd basis, it is likely that some of those animals would eventually develop clinical disease and shed large quantities of virus. Subpoint 4: A critical review of the biological factors associated with model inputs should accompany the choice of the aerosol dispersion model, as the committee was concerned about the proposed data inputs. The inactivation rates of airborne microbes vary significantly in response to environmental exposure. Some critical biological factors are not available as inputs, and those that were proposed were derived from literature and assumptions that are not appropriate or reliable as inputs for viral bioaerosols in the atmospheric environment. This includes, but is not limited to, environmental stability and infectivity decay rates of any of the viruses under consideration derived from limited and dates studies, as mentioned by the DHS contractor. With the conglomerate of environmental affects on airborne microbial inactivation (such as humidity, temperature, and irradiance), the bioaerosol literature cited in the SSRA work plan is tenuous (Barlow, 1972; Donaldson, 1972; Donaldson and Ferris, 1975; Donaldson et al., 1983; Nuanualsuwan et al., 2008). Those studies cannot be reliably extended to provide model virus inputs because they are derived from aqueous environments, were surface associated (such as spider webs), or included anecdotal or incomplete information with specific regard to aerosol behavior. Modern bioaerosol studies—such as work from Tseng and Li (2005)—use carefully controlled chambers and molecular techniques to observe virus aerosol stability under a range of environmental conditions, and would be more appropriate for model inputs; however, FMDv and RVFV have yet to be stringently assessed using this emerging scientific paradigm, and only the most conservative of inactivation parameters may be assumed adequate for engineering-scale modeling.

EVALUATION OF THE NBAF SITE-SPECIFIC RISK ASSESSMENT 108 Question 3.2. Extra-regional spread of FMD: Is our approach to mitigate the inability of NAADSM to model extra-regional spread acceptable? If not, is there an alternative approach to modeling extra-regional spread that addresses this shortfall? Response to 3.2: Other models are capable of modeling spread in the United States (Bates et al., 2003a,b; Schoenbaum and Disney, 2003; Garner et al., 2007; Harvey et al., 2007); some have been the subjects of studies that compared predicted outcomes of models (Dube et al., 2007; Tildesley and Keeling, 2008). The NAADSM (Schoenbaum and Disney, 2003; Harvey et al., 2007) has been adopted by USDA’s Center for Epidemiology and Animal Health because of its user-friendly interface, even though it has not been validated and may not be the best model for assessing spread and mitigation strategies. One study compared model spread predictions (Dube et al., 2007) and provided an estimate of how closely the predictions are correlated; it did not provide a validation of any model, and the SSRA work plan should not presume that the NAADSM has been validated by any reports in literature. The hypothetical spread of FMDv obtained by using NAADSM was compared with that based on AusSpread and Interspread models with a scenario that required simplified assumptions (Dube et al., 2007). Results indicated that the NAADSM yielded far fewer cases of FMD than the other two models. The NAADSM and other models for consideration each have constraints that are subject to user bias and assumptions. The use of NAASDM, or any other model that might be used for the SSRA, should be supplemented with analysis of recent outbreaks to provide ground-truth data, in particular the effects of direct contacts (animal-to-animal) and indirect contacts (fomites, vectors, and personnel), delays in diagnosis, and the effectiveness of mitigation strategies in controlling disease spread. The NAADSM would also need to model multi-regional outbreaks, given the extensive movement of cattle throughout Kansas and neighboring states that could contribute to rapid spread of infection during the time between the occurrence of a release and its detection. The number of cattle should be based on actual movement data, and such interstate movement data should be available from the Kansas state veterinarian’s office. For dealing with spread of an infectious agent beyond the region of Manhattan, the risk assessment might consider network- based models similar to that used by Khan and colleagues (2009) to study H1N1 dispersal. That may provide a simpler and more direct assessment of interstate spread than the proposed approach based on the NAADSM alone. Specifically for FMD, the recent models of Keeling and colleagues (2001) and Tildesley and colleagues (2010) are particularly relevant to issues of regional spread and should be considered. Question 3.3 Shortcomings of NAADSM: Are there additional shortcomings of NAADSM not presented here that we must mitigate to establish a robust system for predicting the spread of FMD from the NBAF? Response to 3.3: As mentioned above, there might be limitations on available data; hence the NAADSM may yield a crude and potentially inaccurate assessment for the SSRA. The other models, such as the models of Keeling and colleagues (2001) and Tildesley and colleagues (2010), also would have difficulty with the poor quality or absence of data. In the absence of established or actual animal movement and contact data, the model can only assume or estimate uncorrelated (random) contacts; this may very well underestimate FMDv spread in that local networks of animal movement can accelerate spread compared with random contacts (direct or indirect) among premises. The constraints of whichever model used for the SSRA will need to be explicitly discussed.

APPENDIX B 109 In preparing this SSRA, there will be substantial uncertainty related to most components, including the laboratory's layout, pathogen characteristics, climate, ecology, environment, and economics. In communicating risk, the SSRA should not hide uncertainty with the complexity of quantitative models. When a modeling exercise is completed, the conclusions reached should only be valued to the extent that they improve mitigation measures and emergency response practices. Among explanations that have similar magnitudes of uncertainty, communication should rely on the simplest and most parsimonious mechanisms. At the same time, the risk assessment should be able to respond to foreseeable changes in uncertainty, and the SSRA should consider mitigation plans for uncertain events. The SSRA will need to consider the potential consequences of events for which the risk is known with limited confidence, and develop plans for mitigating them. For example, estimates for the likelihood of a fomite-mediated pathogen release should be supplemented with consideration of the relevant mitigation models for that particular event. A comprehensive risk assessment will need to consider the mitigation contexts of risk estimates. The committee is concerned that the proposed plan of work does not lay out a detailed plan of mitigation measure modeling. Mitigations measures are themselves complex. They are shaped by logistical and scientific constraints, and their efficacy can critically depend on the details of their implementation. For instance, detection of a release may be difficult for perhaps several weeks after its occurrence, depending on surveillance practices and the biology of the pathogen. That would have an important effect on the nature of mitigation measures after detection. The design of mitigation measures for the NBAF will need to be an iterative process, with the risk assessment informing best practices and best practices informing the risk assessment. A more complete preliminary evaluation of mitigation practices is possible, perhaps on the basis of other laboratories’ practices and response plans. Question 3.4. Modeling of the contribution of wildlife: Is the proposed approach to assess the contribution of wildlife acceptable? If not, what changes are suggested to adequately consider the contribution of wildlife to an FMD outbreak to measure the utility of outbreak mitigation efforts? Response to 3.4: So few data are available that it may be impossible to be conclusive about wildlife density, but the issue should certainly be mentioned. Some species of wildlife, including deer and feral swine, are susceptible to infection with FMDv (Kitching and Alexandersen, 2002), and in past outbreaks they have been destroyed because they pose a threat of infection to outdoor cattle and livestock (Ekboir, 1999). In the event of a pathogen release from the laboratory, the ecology of the environment around the laboratory and the surrounding states may affect pathogen transmission and spread. However, few ecosystems are well understood. The compatibility of native host and vector species with an introduced pathogen is often unknown. Even when hosts are known to be compatible, research has shown that details of ecosystem structure, such as seasonal effects on the timing of pathogen life cycles, can control the presence or absence of endemic disease. The local ecology is likely to be an important source of uncertainty unless there has been targeted research on the pathogen and host and vector species of concern. Rather than attempting to resolve such uncertainty without data, the risk assessment should document the potential for interactions with the local ecosystems and present facts about the demography of the species of concern.

EVALUATION OF THE NBAF SITE-SPECIFIC RISK ASSESSMENT 110 Question 3.5. Approach to predict the spread of FMD from cases caused by a notional aerosol release: Overall, does NAS approve of the proposed approach to assess the effectiveness of site-specific risk mitigation strategies? If not, what are the NAS recommendations for improvement? Response to 3.5: Risk-mitigation strategies are critical in a risk analysis but are underemphasized and lack detail in the work plan. The modeling of outbreak-mitigation strategies requires substantial attention and involves a variety of physical, biological, and economic constraints. A risk assessment should take into account the optimization of mitigation under such constraints and should bound outcomes within the practically and reasonably available mitigation practices. Capabilities, training, and equipping of emergency management, law enforcement, other emergency response organizations, and area hospitals and public health organizations should also be considered as a component of mitigation planning and strategy. Economic Study Question 4.1. Sufficiency of modeling beef and pork industries: Will restricting the economic effects to the beef and pork industries be satisfactory for this SSRA? Response to 4.1: Restricting the analysis to the beef and pork sectors raises concern and leaves the analysis unnecessarily vulnerable to criticism. There will be spillover effects on other sectors—such as dairy, lamb and sheep, and feed crops, particularly forages—because of the animal population in the area of the facility. There will be effects on poultry and eggs with sympathetic price movements and changes in feed costs. Analysis of an outbreak that started in garbage feeding on a small, Midwestern swine operation shows that although the largest losses are confined to beef cattle and swine, the lamb and sheep sectors and poultry meat also experienced losses (Paarlberg et al., 2008). In the scenario analyzed, the dairy, egg, and crop sectors gain increased returns on capital and management (Paarlberg et al., 2008). There are options available to include other sectors. The SSRA could use the beef and pork model developed by Pendell and colleagues (2007) or by Zhao and colleagues (2006) and supplement it with models for dairy, poultry, feed grains, and wheat by using the models reported by Paarlberg and colleagues (2008). The advantage of the Pendell et al. model is that Kansas is identified separately from the rest of the United States, whereas the other models are national and have no regional flavor. The design and methods presented lack depth and breadth of critical considerations for likely economic impacts, including loss of business, loss of government (including military) continuity and function, and economic losses to allied industries after placement of restrictions on the use of animal products for cosmetics and biologics development (for example, the inability to obtain fetal calf serum needed for tissue culture, vaccine development and production, pet foods, and the nutritional-supplement industry that uses “gel caps”). Analysis will need to address the costs associated with military intervention and involvement, assuming the Posse Comitatus Act or some other military action will be necessary, as was the case in the 2001 FMD outbreak in the UK (Chrisafis, 2001). The SSRA should also consider what military resources will be necessary and what it will cost to pull military personnel away from other operations to address an FMD epidemic in the United States. Question 4.2. Interpretation of the term “region”: For both beef and pork, farm-level impacts are segregated between the affected U.S. region and the non-affected U.S. regions (rest of U.S.)

APPENDIX B 111 as well as impacts on beef and pork importers and exporters. Output from the epidemiological model will define the affected region and thus the number of animals affected. The SSRA team’s interpretation of the term “region” is the area determined by the output of the epidemiological model (e.g., State of Kansas, specific counties). Does the NAS Committee agree with this interpretation? If not, please provide a recommended definition. Response to 4.2: The committee disagrees with the interpretation of the term “region” in the SSRA; the region should be expanded to include neighboring states and the SSRA be expanded to include a national assessment as well because the economic impact of FMD will reverberate across state lines and nationally. The modeling should differentiate between regions within which animal movements are restricted and depopulation occurs and areas outside such regions. When one case of FMD is identified, all states will begin implementing plans to mitigate movement into and within their state. Thus, all states will be affected, and all will immediately begin to experience economic losses—closing of borders to milk or animal movement, stop- movement bans on livestock within states, and so on—even if a case has yet to be diagnosed in those states. The affected region will extend beyond the actual area of infection predicted by the models. A control zone with a radius of at least 10 km (6.2 miles)—covering a minimum of 120 square miles—will be established around each infected premises (Jon Zack, USDA-APHIS-VS, personal communication, January 26, 2010). All animal movement will be stopped in the control zone. Any dangerous-contact premises in the zone will probably be depopulated without waiting for evidence of infection. The definition of region should conform to anticipated control zones in the USDA–APHIS outlined FMD Preparedness and Response Plan (FMD PReP) (provided on request by the USDA–APHIS–VS National Center for Animal Health Emergency Management), including regions around secondary and tertiary spread. National models—such as those of Devadoss et al. (2006), Zhao et al. (2006), Pendell et al. (2007), and Paarlberg et al. (2008)—generate price, quantity, and economic welfare changes from three potential shocks. One shock is the depopulation of animals relative to the national herd; the second is the loss of exports, as discussed below; and the third is potential adverse consumer reaction (Paarlberg et al., 2002). The aggregate of the three shocks determines national impacts. National impacts will reflect price changes but will not include government costs of maintaining containment regions or business costs of disruption in affected areas. Question 4.3. Aggregation of output scenarios: Given the sizeable number of scenarios that may be generated by the plume and epidemiological models, will it be sufficient to aggregate the financial output values into high, medium and low economic impact categories? Each range provided will have specific dollar values indicated and specify the scenarios that are represented. Response to 4.3: The scenarios can be aggregated. A critical driver of how the results can be grouped will probably be the duration of the outbreak. Because the losses from export restrictions and adverse consumer reactions are time-dependent (Paarlberg et al., 2008), outbreak duration is critical in the magnitude of effects (Paarlberg et al., 2009). The magnitude of animal depopulation also plays a role in determining which scenarios can be aggregated (Paarlberg et al., 2008). It is not possible to determine aggregation rules a priori, but it should be possible to aggregate once durations and supply losses are known. Question 4.4. Trade ban timeframe: Economic studies specifically evaluating the impact of a domestic FMD outbreak differ in their assumptions of the length of the anticipated trade ban. Additionally, any projected length of trade ban is related to the duration and scope of the

EVALUATION OF THE NBAF SITE-SPECIFIC RISK ASSESSMENT 112 impacted area. Trade ban is referring to the length of time the United States would not be permitted to trade because of an event (FMD outbreak). Based on a letter to DHS from the Director General, OIE (November 24, 2008) that states: "Once they could demonstrate that all cases could be contained within such zone and that no further cases were detected within a 30 day period, the entire country regained its FMD free status, within the only exception of the containment zone" we recommend a baseline trade ban of 45-60 days. Does the NAS Panel agree with this trade ban timeframe? Response to 4.4: The trade ban length of 45–60 days is too short. The OIE director general’s comment assumes that the United States could regionalize as Brazil and Argentina have during recent FMD outbreaks. However, the regionalization decision for the United States would need to be acceptable to importers, who would need to believe that the United States could isolate any FMD risk within the containment region. As in the situation of a potential outbreak of highly pathogenic avian influenza, it is the trade partners’ response that determines whether regionalization occurs (Paarlberg et al., 2007). The key issues are the number of susceptible animals in the region relative to the U.S. herd and the extent of connections between the containment region and the rest of the livestock economy. The question can be addressed by examining the animal population around Manhattan, using an assumed radius of 100 miles and an assumed radius of 200 miles to set an area that can be used to illustrate animal density. The area in question is primarily a beef-cattle region with some dairy cattle and swine, so the January 2009 total cattle inventory data by county can be used (USDA-NASS, 2009). A 100-mile radius extends eastward to Kansas City; northward to include Beatrice, Nebraska; southward to south central Kansas; and westward nearly to Russell, Kansas. The area contains about 2% of the total U.S. cattle inventory (USDA-NASS, 2009). Extending the radius to 200 miles means a north–south range from about Norfolk, Nebraska, to Tulsa, Oklahoma. The east–west range is from just beyond Sedalia, Missouri, almost to Oakley, Kansas. The area examined includes most of Kansas, large parts of Nebraska and Missouri, western Iowa, and northern Oklahoma. Including western Iowa and Missouri means that substantial regions of swine production fall within the circle. Roughly 9.5% of the U.S. cattle inventory is in this area (USDA-NASS, 2009). With respect to transportation, the circle within a 100-mile radius includes long sections of Interstates 70 and 135. It includes westward rail service out of Kansas City. Extending the zone to a 200-mile radius adds sections of Interstates 80 and 29 and the main line of the Union Pacific Railroad. Kansas City, Hastings, and Grand Island, Nebraska, are well within the larger zone. The cities included have several meatpacking plants. Omaha, Nebraska, and its stockyards are in the larger circle. Norfolk, Nebraska; Tulsa, Oklahoma; and Council Bluffs and Sioux City, Iowa, are in the zone or on its perimeter. The ability to isolate the region seems unlikely, given the share of the U.S. cattle inventory in the circles, the transportation links across them, the Omaha stockyards, and the packing plants in the cities included. Thus, trade partners probably would not accept regionalization. Japan and Korea have been major trading partners for meat. They did not regionalize after the cases of bovine spongiform encephalopathy (BSE) in the United States and Canada, nor did they regionalize after the FMD outbreaks in Taiwan and Britain. Therefore, it is assumed that the United States could not regionalize an outbreak centered in Manhattan, Kansas. For a country like the United States, which is initially FMD-free and does not vaccinate, the time to regain FMD-free status will depend on the control actions taken during an outbreak.

APPENDIX B 113 If there is a stamping-out policy (that is, depopulation) and serological surveillance without emergency vaccination, FMD-free status could be regained as soon as 3 months after the last case (OIE, 2009). If emergency vaccination is undertaken in conjunction with a stamping-out policy and serological surveillance, FMD-free status could be regained 3 months after the last vaccinated animal is slaughtered (OIE, 2009). If vaccinated animals are not slaughtered, the time to recover FMD-free status changes to 6 months after the last case and is contingent on the results of a serological survey (OIE, 2009). The OIE Terrestrial Animal Health Code, in Articles 8.5.10–8.5.31, identifies importation guidelines for animals and animal products. For animals, recommendations are for international veterinary certificates that indicate that the animals have no signs of FMD and were isolated and quarantined for 30 days to 3 months before export, depending on the exporting nation’s disease status with negative FMD diagnostic tests (OIE, 2009). Similar rules apply to semen and embryos from donor animals included in isolation, quarantine, and tests (OIE, 2009). Meat can be imported from countries with cases of FMD with the following recommendations: the entire shipment comes from an approved slaughterhouse that has ante- mortem and post-mortem inspections for FMD, and the meat has been processed to destroy FMDv. OIE Article 8.5.32 describes such processing as consisting of canning of meat heated to 70°C for 30 minutes, cooking deboned and defatted meat up to an internal temperature of 70°C for 30 minutes, or drying salted, deboned meat. Imported milk, cream, and milk product also are to have a veterinary certificate stating that they originated in FMD-free herds and have been processed to destroy the virus (OIE, 2009). Such processing includes heat treatments and hermetic sealing in containers. Cheese, butter, and yogurt are generally not restricted, but condensed milk, sterilized milk, and casein may be restricted (OIE, 2009). FMDv transmission from animals to humans is rare and is not a public health concern. Evidence from other exporters with FMD suggests delay in export recovery beyond the OIE guidelines. Taiwan experienced an outbreak in spring 1997 (USDA-FAS, 1997). Before the outbreak, that nation exported pork to Japan. As a consequence of the outbreak, exports were stopped, and they have not recovered as Taiwan regionalized its pork industry (USDA-FAS, 1998, 2000). Britain experienced an FMD outbreak starting at the end of February 2001, with the last cases occurring the week of September 24 (UK-MAFF, 2002). An important dimension of the British situation is the presence of BSE and the fact that a link between BSE and variant Creutzfeldt-Jakob disease in humans had been announced in March 1996 (Brown, 1997). Export restrictions were imposed immediately by the British government (USDA-FAS, 2001). Restrictions imposed by the European Union on British exports were lifted a year later, on March 6, 2002 (Johnson, 2005). Japan lifted its restrictions on October 6, 2003 (Johnson, 2005). Despite the end of all restrictions on British exports, exports did not return to pre-outbreak levels until fall 2004 (Johnson, 2005). The quarterly pattern shows that British exports did not begin to recover until the second quarter of 2002, 3 quarters after the last reported case (Johnson, 2005). Exports recovered throughout 2002 and reached a plateau in the first half of 2003 (Johnson, 2005). Starting in late 2003, exports moved to a new plateau, which lasted until summer 2004; recovery was complete in fall 2004 (Johnson, 2005). For FMD, the export impacts might be a total ban on exports of beef, pork, lamb, beef cattle, dairy cattle, hogs, lambs, and sheep during and 1 quarter after the outbreak. On the basis of the product rules set out by OIE and U.S. export data from the U.S. International Trade Commission, about one-third of dairy product exports could also be lost (USITC, 2009). Exports

EVALUATION OF THE NBAF SITE-SPECIFIC RISK ASSESSMENT 114 would gradually recover, as did British exports, with full recovery perhaps 8 quarters after recovery begins. Trading partners have a strong economic motivation to delay accepting imports. The SSRA should consider the extensive losses to the swine industry due to the outbreak of pandemic H1N1 virus (so-called swine flu) as an instructive model. No pigs in the United States were detected as infected; however, major trading partners used the opportunity to reduce imports of U.S. pork. Any consideration of economic consequences will need to acknowledge the possibility of a similar reaction if it is to have credibility in the livestock industry. Question 4.5. Critical economic infrastructure threshold: We propose the critical economic infrastructure include; the value of livestock affected directly or indirectly by an outbreak, and the value of any damage to facilities and equipment in the case of an accidental or intentional release. Does the NAS panel agree with this definition, if not, what modifications to this definition should be made? Response to 4.5: The critical economic infrastructure should include 1. The prevailing market value before the epidemic of livestock depopulation; 2. The change in returns to livestock producers with animals not depopulated; 3. The changes in returns to upstream and downstream industries; 4. Changes in consumer welfare; 5. Effects on nonagricultural sectors; and 6. Effects on the local, state, and national communities—employment, and so on. The first four should be determined by the agricultural sector model used to determine the national effects of the outbreak on agriculture. Effects on non-agricultural sectors could be determined from an applied general equilibrium model of the United States. Devadoss and colleagues (2006) used such a model to examine BSE, and DHS should be able to gain access to that model. Effects on the local community of Manhattan could be generated with regional input–output modeling. Final Report Question 5.1. Content and order of Final Report outline: Is the content and general order of items presented in the Final Report Draft Outline acceptable? Response to 5.1: The general order of items presented in the final report draft outline is acceptable. However, the contents of the draft report should be revised to address the committee’s general concerns regarding the SSRA’s pathways, pathogens and hosts, practices, mitigation strategies, and site-specific analysis. The committee would like the SSRA to include a scenario for Nipah virus or Hendra virus escape, and for the acquisition and handling of a highly pathogenic emerging zoonotic agent with unknown characteristics (perhaps using the example of how Nipah, a previously unknown BSL-4 pathogen, was handled from a diagnostic sample). Question 5.2. Final Report outline topics: Are there topics that should be added, deleted, or for which the order should be changed? Response to 5.2: The committee proposes a few suggested changes in Appendix B-1.

APPENDIX B 115 Rift Valley Fever Amendment Amendment Question 1: Parameters for RVFV release from NBAF: Do these parameters reflect the best available scientific evidence? If not, what evidence should be used to parameterize these qualities of RVFV? We will perform sensitivity analysis with each uncertain parameter to understand the effect of uncertainty on our analysis. Response to Amendment Question 1: A justification was not provided for the selection of the SCIPUFF model over other dispersion models, and no peer-reviewed literature was provided. As indicated by the World Health Organization, aerosol is not the main transmission route of Rift Valley fever virus (RVFV) (WHO, 2007). The committee reiterates its concern about the SSRA’s basing its epidemiological modeling exclusively on airborne escape from the laboratory. As mentioned above, the four routes recommended for FMDv would apply similarly to RVFV and all other pathogens that may be studied in the NBAF. The SSRA should present the key primary data and source references. The committee recommends that the SSRA receive substantial input from subject matter experts to assist with literature reviews and to obtain parameter data. As noted above for FMDv, details on the ID- response determinations remain important for any other animal pathogens and zoonotic agents considered for study. The relevance of the test animals in the infectious dose studies, dosing, dosing determination, relative virulence of organism strains, and comparative response in humans (in the case of zoonotic pathogens) should be appropriately summarized with citations to source data. As in the case of FMDv dispersion, LD50 is inappropriate inasmuch as it is necessary for only one animal or person to be infected (LD1) for an RVFV escape to have catastrophic consequences. Before dismissing the wildlife component, the type and distribution of wildlife (beyond deer) that exist in the region should be determined. Amendment Question 2: Evidence basis of prospective epidemiological RVF modeling: Is the evidence basis for the prospective epidemiological modeling of RVF within non-endemic areas sufficient to produce a useful and defensible model? Response to Amendment Question 2: The evidence provided by the SSRA work plan is inadequate to support an epidemiological RVFV model for spread and dispersion. The epidemiological RVFV model will need to adequately differentiate urban and rural areas. Vector spread of RVFV and the theoretical risk of human-to-human transmission of the virus from infected patients to healthcare workers in Manhattan, Kansas, would probably be quite different from those in rural areas of the developing world on which there are data. In its epidemiological model and mitigation strategy, the SSRA should also include the likelihood of eradicating and the time needed to eradicate infected vectors and infected animal reservoirs, such as cattle and sheep. Amendment Question 3: Robustness of prospective epidemiological RVF modeling: Overall, is this approach robust and evidence-based enough to adequately assess the effectiveness of risk mitigation strategies in this project? If this approach is not considered robust enough for this project, how should this approach be improved? Response to Amendment Question 3: RVF is a vector-borne disease, so the SSRA will especially need to consider the possibility of a laboratory worker being bitten by an RVFV-

EVALUATION OF THE NBAF SITE-SPECIFIC RISK ASSESSMENT 116 infected mosquito or the possibility of RVFV-infected mosquitoes’ escaping from containment. The SSRA will also need to address mitigation steps for a zoonotic disease that can be maintained in animal hosts and mosquitoes and their eggs. One crucial mitigation step would be a public education campaign about RVF so that members of the public will know how to protect themselves and how to recognize signs of disease in humans and animals. Ruminants are amplifying hosts, so an important mitigation strategy would be to have a stockpile of RVF vaccine available for use in ruminants in the event of an outbreak by the time the NBAF opens. Other elements of mitigation to be considered should include vector control, spraying, testing, and surveillance implementation to test for RVFV in potential host populations, including humans. Amendment Question 4: Parametric approach to cost of illness: Data which establish the cost of illness (COI) resulting from the introduction of RVF will be estimated parametrically from related economic impact studies of other zoonotic diseases (e.g., West Nile Virus, H5N1, H1N1). Does the NAS Committee concur with this approach and are there any specific references/studies suggested that may assist the team with this aspect of the analysis? Response to Amendment Question 4: The parametric approach to the cost of illness proposed by the SSRA does not take into account the science and biology of RVF, but it will need to do so. The economic impact studies from H1N1 and H5N1 will not necessarily apply to a vector-borne zoonosis such as RVF, thus the model is not a one-size-fits-all model. The cost of an illness will depend on its severity and treatment for it, so the cost incurred because of RVF should be different from the cost incurred because of H1N1 or H5N1 influenza or West Nile virus (WNV), and the difference will have to be incorporated into the economic assessment. Also, assessing the cost of illness for RVF is complex because the assessment will need to consider impacts on both human and animal populations. Estimates for major economic losses due to livestock and trade restrictions for RVF- infected livestock can be quantifiable. Determination of the cost of infection should consider costs associated with animal morbidity, including abortion. An outbreak of RVF would cause U.S. trading partners to stop importation of at least beef and lamb, and perhaps pork, until there is proof that RVFV has been eliminated. It will be difficult to conduct surveillance to prove that the nation is free of RVFV, given that the virus is capable of surviving in mosquito eggs for extended periods of time (WHO, 2007). However, to address the cost of illness for humans alone, the assessment would need to include the cost of disease, public health response costs, direct healthcare costs, productivity losses, and additional economic costs. As an example, the economic impact from the 329 cases in the 2002 Louisiana WNV epidemic resulted in $20.1 million in human medical, non-medical, and public health response costs (Zohrabian et al., 2004). However, for a pathogen such as RVFV, there is no evidence of RVF outbreaks in urban areas (WHO, 2007) and the likelihood of North American mosquitoes acting as efficient RVFV vectors outside the laboratory setting is still uncertain (Turell et al., 2008). Furthermore, it is uncertain how the economic impacts on human health for RVF in developing countries would translate to potential economic health impacts in the United States where the healthcare system differs. Thus the committee believes it would be difficult to provide a reliable estimate for the cost of illness for RVF by benchmarking it to other zoonoses.

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EVALUATION OF THE NBAF SITE-SPECIFIC RISK ASSESSMENT 120 NRC. 2007. Technical input on the National Institutes of Health’s Draft Supplemental Risk Assessments and Site Suitability Analyses for the National Emerging Infectious Diseases Laboratory, Boston University: A Letter Report. Washington, DC: The National Academies Press. NRC. 2008. Technical input on any additional studies to assess risk associated with operation of the National Emerging Infectious Diseases Laboratory, Boston University: A Letter Report. Washington, DC: The National Academies Press. NRC. 2009. Responsible Research with Biological Select Agents and Toxins. Washington, DC: The National Academies Press. NRC. 2010. Evaluation of the Health and Safety Risks of the New USAMRIID Facilities at Fort Detrick, Maryland. Washington, DC: The National Academies Press. Nuanualsuwan, S., P. Thongtha, S. Kamolsiripichaiporn, and S. Subharat. 2008. UV inactivation and model of UV inactivation of foot-and-mouth disease viruses in suspension. International Journal of Food Microbiology 127(1-2):84-90. OIE (World Organisation for Animal Health). 2009. Terrestrial Animal Health Code (Article 8.5.8). Available online at www.oie.org [accessed October 20, 2009]. Paarlberg, P.L., J.G. Lee, and A.H. Seitzinger. 2002. Potential revenue impacts of a foot-and- mouth disease outbreak in the United States. Journal of the American Veterinary Medical Association 220(7):988-992. Paarlberg, P.L., A. Hillberg Seitzinger, and J.G. Lee. 2007. Economic impacts of regionalization of a highly pathogenic avian influenza outbreak in the United States, Journal of Agricultural and Applied Economics 39(2): 325-333. Paarlberg, P.L., A. Hillberg Seitzinger, J.G. Lee, and K.H. Mathews, Jr. 2008. Economic Impacts of Foreign Animal Disease. Economic Research Report Number 57. Economic Research Service, U.S. Department of Agriculture: Washington, DC. Appendix table 15. Paarlberg, P.L., A. Hillberg Seitzinger, J.G. Lee, K.H. Mathews, Jr. 2009. Supply reductions, export restrictions, and expectations for hog returns in a potential classical swine fever outbreak in the United States. Journal of Swine Health and Production 17(3):155-162. Pendell, D.L., J. Leatherman, T.C. Schroeder, and G.S. Alward. 2007. The economic impacts of a foot-and-mouth disease outbreak: A regional analysis. Journal of Agricultural and Applied Economics 39:13-33. Peters, R.G., V.T. Covello, and D.B. McCallum. 1997. The determinants of trust and credibility in environmental risk communication: an empirical study. Risk Anal 17(1):43-54. Reed, L.J., and H. Muench. 1938. A simple method of estimating fifty percent endpoints. The American Journal of Hygiene 27:493–497. Reynolds, B. 2008. Some threats to laboratory research require an unusual antidote. Applied Biosafety 13(3):138-141. Sandman, P.M. 1990. Getting to Maybe: Some Communications Aspects of Siting Hazardous Waste Facilities in “Readings in Risk", T.S. Glockman, M. Gough Eds,. Washington, DC: Resources for the Future pp. 233-245. Schley, D., L. Burgin, and J. Gloster. 2009. Predicting infection risk of airborne foot-and-mouth disease. J. R. Soc. Interface 6(34):455-462. Schoenbaum, M.A., and W.T. Disney. 2003. Modeling alternative mitigation strategies for a hypothetical outbreak of foot-and-mouth disease in the United States. Preventive Veterinary Medicine 58:25-52.

APPENDIX B 121 Sellers, R.F., A.I. Donaldson, and K.A.J. Herniman. 1970. Inhalation, persistence, and dispersal of foot-and-mouth disease virus by man. J Hyg (Lond) 68(4):565-573. Sellers, R.F., K.A. Herniman, and J.A. Mann. 1971. Transfer of foot-and-mouth disease virus in the nose of man from infected to non-infected animals. Vet Rec 89(16):447-449. Sellers, R.F., and J. Gloster. 2007. Foot-and-mouth disease: a review of intranasal infection of cattle, sheep and pigs. Vet J 177(2):159-168. Sørensen, J.H., D.K. Mackay, C.O. Jensen, and A.I. Donaldson. 2000. An integrated model to predict the atmospheric spread of foot-and-mouth disease virus. Epidemiol Infect 124(3):577-590. Sørensen, J.H., C.O. Jensen, T. Mikkelsen, D.K.J. Mackay, and A.I. Donaldson. 2001. Modelling the atmospheric dispersion of foot-and-mouth disease virus for emergency preparedness. Phys Chem Earth 26:93–97. Sørensen, J.H. 2003. Modelling the Atmospheric Spread of Foot-and-Mouth Disease. Danish Meteorological Institute, Scientific Report: 03-17. Available online at http://www.dmi.dk/dmi/sr03-17.pdf [accessed March 17, 2010]. Tildesley, M., and M. Keeling. 2008. Modelling foot-and-mouth disease: A comparison between the UK and Denmark. Preventive Veterinary Medicine 85:107–124. Tildesley, M.J. T.A. House, M.C. Bruhn, R.J. Curry, M. O’Neil, J.L.E. Allpress, G. Smith, and M.J. Keeling. 2010. Impact of spatial clustering on disease transmission and optimal control. PNAS 107(3):1041-1046. Tinline, R. 1970. Lee wave hypothesis for the initial pattern of spread during the 1967-68 foot- and-mouth epizootic. Nature 227(5260):860-862. Tseng, C.-C., and C.-S. Li. 2005. Inactivation of virus-containing aerosols by ultraviolet germicidal irradiation. Aerosol Sci and Technol 39(12):1136-1142. Turell, M.J., D.J. Dohm , C.N. Mores, L. Terracina, D.L. Wallette Jr., L.J. Hribar, J.E. Pecor, and J.A. Blow. 2008. Potential for North American mosquitoes to transmit Rift Valley fever virus. J Am Mosq Control Assoc 24(4):502-507. UK-MAFF (United Kingdom, Ministry of Agriculture, Forestry and Fisheries). 2002. “Foot & Mouth Disease Daily Situation Report.” Available online at www.maff.gov.uk. accessed weekly from March 29, 2001-January 14, 2002. USDA-FAS (United States Department of Agriculture, Foreign Agricultural Service). 1997. Taiwan Livestock and Products Annual,TW7029, July 21,1997. Available online at www.fas.usda.gov [accessed November 4, 2009]. USDA-FAS. 1998. Taiwan Livestock and Products Annual, TW8021, July 16, 1998. Available online at www.fas.usda.gov [accessed November 4, 2009]. USDA-FAS. 2000. Taiwan Livestock and Products Semi-Annual, GAIN Report TW0006, February 2, 2000. Available online at www.fas.usda.gov [accessed November 4, 2009]. USDA-FAS. 2001. “United Kingdom Livestock and Products , UK Outbreak of Foot and Mouth Disease Confirmed 2001.” Gain Report #UK1007, February 21, 2001. Available online at www.fas.usda.gov [accessed March 2, 2010]. USDA-NASS (U.S. Department of Agriculture, National Agricultural Statistics Service). 2009. “Quick Stats -- Statistics by State, Livestock Inventory January 2009Agricultural Statistical Annual.” Available online at nass.usda.gov/statistics by state [accessed October 20 2009]. USITC (United States International Trade Commission). 2009. Trade data web. (2008 Quarter 1- 2009 Quarter 2 data) Available online at www.usitc.gov [accessed October 20.2009].

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Appendix B-1 Committee’s Revisions to Draft Final Report Outline The committee’s suggested revisions to the draft final report outline are noted in bolded underline for additions and strikethrough for deletions. I. Executive Summary a. Overview i. NBAF Purpose and Benefits ii. Site-Specific Risk Assessment Objectives b. Results i. Best Practices Overview for Manhattan Design and Operations 1. Design 2. Operations 3. Mitigation ii. Reasonable Maximum Credible Risk Worst-Case Scenario Outcomes 1. Assumptions a. Baseline Best Practices b. Site-Specific Considerations 2. Outcomes and Impact a. Extent of Pathogen Dispersion b. Potential Spread of Associated Disease c. Economic Impact c. Site-Specific Risk Assessment Conclusions and Recommendations II. Purpose and Objectives a. Define Best Practices i. Design and Construction ii. Operations iii. Personnel reliability (consider this to be handled by DHS and not specific to the SSRA) iv. Emergency and Contingency Planning b. Identify Potential Release Scenarios i. Accidental ii. Intentional c. Model Outcomes i. Fate and Transport Plume Modeling (through 4 categories of pathways) 1. air 2. solid waste 123

EVALUATION OF THE NBAF SITE-SPECIFIC RISK ASSESSMENT 124 3. liquid waste 4. in/on fomites or hosts ii. Epidemiological Modeling iii. Economic Consequence Assessments d. Develop Strategies for Prevention and Mitigation of Reasonable Maximum Credible Risk Worst-Case Scenarios III. Technical Approach a. Expertise i. Subject Matter Experts ii. Key Personnel b. Risk Management c. Technical Tasks i. Emergency and Contingency Planning Requirements Review and Baseline Mitigation Strategy Development (Task 01) 1. Review of Best Practices, Mitigation Strategies, Risk Communication, and Emergency Response Plans at Domestic and International Sites 2. Review of Findings with US Government Team and Discussion of NBAF Response Plans with national, regional, state, and local responders 3. Development of a Baseline Mitigation Strategy for the NBAF including Local/State/Federal strategies. ii. Scenario Review (Task 02) 1. Scenario Database Development and Boundary Conditions 2. SME Panel Scenario Review iii. Data Collection (Task 08) 1. Animal 2. Transportation 3. Human Population and Health 4. Insect Vector 5. Building iv. Plume Modeling (Task 04) 1. Model and Source Term Development 2. Meteorological Data Preparation 3. Modeling Plan Development and Review 4. Model Setup 5. Modeling Simulations 6. Post-process Model Results Evaluation 7. Plume-Model Report Development and Review v. Epidemiological Study (Task 05) 1. Data Collection 2. Existing Epidemiological Model Assessment 3. FMDv and RVFV Model Development 4. Parametric Assessment of FMDv and RVFV Release vi. Economic Study (Task 06) 1. Pre-release Market Conditions Assessment 2. Post-release Market Conditions Assessment 3. Animal Commodity Flow

APPENDIX B-1 125 4. Containment and Animal Stop Zones 5. Critical Economic Infrastructure and Key Resources 6. Trade Impacts 7. Economic Study Report Development and Review d. Process and Data Flow e. Reports and Deliverables (Task 07, plus portions of Tasks 2,4,5,6,& 8) IV. Results a. Best Practices b. Data Collection c. Scenario Database d. Plume Modeling e. Epidemiological Studies f. Economic Studies g. Risks V. Conclusions and Recommendations a. Reasonable Maximum Credible Risk Worst-Case Scenario Outcomes b. Reasonable Maximum Credible Risk Worst-Case Scenario Mitigation Strategy c. Recommendations VI. Bibliography VII. Supporting Data (Order subject to change dependant on order in which they are referenced in the Final Report) a. Appendix A: Collected Data Sets b. Appendix B: Best Practices: Response Strategies c. Appendix C: Best Practices: Mitigation Strategies d. Appendix D: Scenario Database e. Appendix E: Plume Models (Modeling Plans and Final Report) f. Appendix F: Epidemiological Models g. Appendix G: Economic Consequence Models

EVALUATION OF THE NBAF SITE-SPECIFIC RISK ASSESSMENT 126

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Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas Get This Book
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Congress requested that the U.S. Department of Homeland Security (DHS) produce a site-specific biosafety and biosecurity risk assessment (SSRA) of the proposed National Bio- and Agro-Defense Facility (NBAF) in Manhattan, Kansas. The laboratory would study dangerous foreign animal diseases—including the highly contagious foot-and-mouth disease (FMD), which affects cattle, pigs, deer, and other cloven-hoofed animals—and diseases deadly to humans that can be transmitted between animals and people. Congress also asked the Research Council to review the validity and adequacy of the document. Until these studies are complete, Congress has withheld funds to build the NBAF.

Upon review of the DHS assessment, the National Research Council found "several major shortcomings." Based on the DHS risk assessment, there is nearly a 70 percent chance over the 50-year lifetime of the facility that a release of FMD could result in an infection outside the laboratory, impacting the economy by estimates of $9 billion to $50 billion. The present Research Council report says the risks and costs of a pathogen being accidently released from the facility could be significantly higher. The committee found that the SSRA has many legitimate conclusions, but it was concerned that the assessment does not fully account for how a Biosafety-Level 3 Agriculture and Biosafety-Level 4 Pathogen facility would operate or how pathogens might be accidently released. In particular, the SSRA does not include important operation risks and mitigation issues, such as the risk associated with the daily cleaning of large animal rooms. It also fails to address risks that would likely increase the chances of an FMD leak or of the disease's spread after a leak, including the NBAF's close proximity to the Kansas State University College of Veterinary Medicine clinics and KSU football stadium or personnel moving among KSU facilities.

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