National Academies Press: OpenBook
Suggested Citation:"Front Matter." National Research Council. 2012. Evaluation of the Updated Site-Specific Risk Assessment for the National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13418.
×

Evaluation of the Updated

Site-Specific Risk Assessment for the

NATIONAL BIO- AND AGRO-DEFENSE

FACILITY IN MANHATTAN, KANSAS

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

Board on Life Sciences

Board on Agriculture and Natural Resources

Division on Earth and Life Studies

NATIONAL RESEARCH COUNCIL
OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS
Washington, D.C.
www.nap.edu

Suggested Citation:"Front Matter." National Research Council. 2012. Evaluation of the Updated Site-Specific Risk Assessment for the National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13418.
×

THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001

NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance.

This study was supported by Task Order HSFLBP-11-J-00002/Contract HSHQDC-11-D-00009 between the National Academy of Sciences and Department of 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.

International Standard Book Number-13: 978-0-309-25782-4
International Standard Book Number-10: 0-309-25782-4

Additional copies of this report are available for sale from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http://www.nap.edu/.

Copyright 2012 by the National Academy of Sciences. All rights reserved.

Printed in the United States of America.

Suggested Citation:"Front Matter." National Research Council. 2012. Evaluation of the Updated Site-Specific Risk Assessment for the National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13418.
×

THE NATIONAL ACADEMIES

Advisers to the Nation on Science, Engineering, and Medicine

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

Suggested Citation:"Front Matter." National Research Council. 2012. Evaluation of the Updated Site-Specific Risk Assessment for the National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13418.
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×

COMMITTEE ON THE EVALUATION OF THE UPDATED SITE-SPECIFIC RISK ASSESSMENT FOR THE NATIONAL BIO- AND AGRO-DEFENSE FACILITY IN MANHATTAN, KANSAS

GREGORY B. BAECHER (Chair), University of Maryland, College Park, MD

THOMAS W. ARMSTRONG, TWA8HR Occupational Hygiene Consulting, LLC, Branchburg, NJ

RICHARD E. BREITMEYER, University of California, Davis, CA

CORRIE C. BROWN, University of Georgia, Athens, GA

MARK T. HERNANDEZ, University of Colorado Boulder, Boulder, CO

AHSAN KAREEM, University of Notre Dame, Notre Dame, IN

BRENDAN MCCLUSKEY, University of Medicine and Dentistry of New Jersey, Newark, NJ

ALI MOSLEH, University of Maryland, College Park, MD

STEPHEN M. OSTROFF, Pennsylvania Department of Health, Harrisburg, PA

PHILIP L. PAARLBERG, Purdue University, West Lafayette, IN

TIMOTHY C. RELUGA, Pennsylvania State University, University Park, PA

JOSEPH V. RODRICKS, ENVIRON, Arlington, VA

JAMES A. ROTH, Iowa State University, Ames, IA

LEE H. THOMPSON, University of Texas Medical Branch at Galveston, Galveston, TX

MARK C. THURMOND, University of California, Davis, CA

AKULA VENKATRAM, University of California, Riverside, CA

PATRICK M. WEBB, National Pork Board, Des Moines, IA

Staff

PEGGY TSAI, Study Director and Program Officer

CARL-GUSTAV ANDERSON, Program Associate

KATHLEEN REIMER, Senior Program Assistant

FRANCES E. SHARPLES, Director, Board on Life Sciences

ROBIN A. SCHOEN, Director, Board on Agriculture and Natural Resources

NORMAN GROSSBLATT, Senior Editor

Suggested Citation:"Front Matter." National Research Council. 2012. Evaluation of the Updated Site-Specific Risk Assessment for the National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13418.
×

BOARD ON LIFE SCIENCES

KEITH R. YAMAMOTO (Chair), University of California, San Francisco, CA

BONNIE L. BASSLER, Princeton University, Princeton, NJ

VICKI L. CHANDLER, Gordon and Betty Moore Foundation, Palo Alto, CA

SEAN EDDY, HHMI Janelia Farm Research Campus, Ashburn, VA

MARK FITZSIMMONS, John D. and Catherine T. MacArthur Foundation, Chicago, IL

DAVID R. FRANZ, Former Cdr USAMRIID, Frederick, MD

LOUIS J. GROSS, University of Tennessee, Knoxville, TN

RICHARD A. JOHNSON, Arnold & Porter, LLC, Washington, DC

CATO T. LAURENCIN, University of Connecticut Health Center, Farmington, CN

ALAN I. LESHNER, American Association for the Advancement of Science, Washington, DC

BERNARD LO, University of California, San Francisco, CA

ROBERT M. NEREM, Georgia Institute of Technology, Atlanta, GA

MURIEL E. POSTON, Skidmore College, Saratoga Springs, NY

ALISON G. POWER, Cornell University, Ithaca, NY

MARGARET RILEY, University of Massachusetts, Amherst, MA

BRUCE W. STILLMAN, Cold Spring Harbor Laboratory, Cold Spring Harbor, NY

CYNTHIA WOLBERGER, Johns Hopkins University School of Medicine, Baltimore, MD

MARY WOOLLEY, Research!America, Alexandria, VA

Staff

FRANCES E. SHARPLES, Board Director

JO L. HUSBANDS, Scholar/Senior Project Director

JAY B. LABOV, Senior Scientist/Program Director for Biology Education

KATHERINE W. BOWMAN, Senior Program Officer

INDIA HOOK-BARNARD, Senior Program Officer

MARILEE K. SHELTON-DAVENPORT, Senior Program Officer

KEEGAN SAWYER, Program Officer

BETHELHEM M. BANJAW, Financial Associate

ORIN E. LUKE, Senior Program Assistant

CARL-GUSTAV ANDERSON, Program Associate

SAYYEDA AYESHA AHMED, Senior Program Assistant

Suggested Citation:"Front Matter." National Research Council. 2012. Evaluation of the Updated Site-Specific Risk Assessment for the National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13418.
×

BOARD ON AGRICULTURE AND NATURAL RESOURCES

NORMAN R. SCOTT (Chair),1 Cornell University, Ithaca, NY

PEGGY F. BARLETT, Emory University, Atlanta, GA

HAROLD L. BERGMAN, University of Wyoming, Laramie, WY

RICHARD A. DIXON,2 Samuel Roberts Noble Foundation, Ardmore, OK

DANIEL M. DOOLEY, University of California, Oakland, CA

JOAN H. EISEMANN, North Carolina State University, Raleigh, NC

GARY F. HARTNELL, Monsanto Company, St. Louis, MO

GENE HUGOSON, Global Initiatives for Food Systems Leadership, St. Paul, MN

MOLLY M. JAHN, University of Wisconsin-Madison, WI

ROBBIN S. JOHNSON, Cargill Foundation, Wayzata, MN

A.G. KAWAMURA, Solutions from the Land, Washington, DC

KIRK C. KLASING, University of California, Davis, CA

JULIA L. KORNEGAY, North Carolina State University, Raleigh, NC

VICTOR L. LECHTENBERG, Purdue University, West Lafayette, IN

JUNE BOWMAN NASRALLAH,2 Cornell University, Ithaca, NY

PHILIP E. NELSON, Purdue University, West Lafayette, IN

KEITH PITTS, Marrone Bio Innovations, Davis, CA

CHARLES W. RICE, Kansas State University, Manhattan, KS

HAL SALWASSER, Oregon State University, Corvallis, OR

ROGER A. SEDJO, Resources for the Future, Washington, DC

KATHLEEN SEGERSON, University of Connecticut, Storrs, CN

MERCEDES VAZQUEZ-AÑON, Novus International, Inc., St. Charles, MO

Staff

ROBIN A. SCHOEN, Board Director

AUSTIN J. LEWIS, Senior Program Officer

EVONNE P.Y. TANG, Senior Program Officer

CAMILLA YANDOC ABLES, Program Officer

KARA N. LANEY, Program Officer

PEGGY TSAI, Program Officer

JANET M. MULLIGAN, Senior Program Associate for Research

RUTH S. ARIETI, Research Associate

KAREN L. IMHOF, Administrative Coordinator

KATHLEEN REIMER, Senior Program Assistant

image

1Member of the National Academy of Engineering

2Member of the National Academy of Sciences

Page viii Cite
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Acknowledgments

This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Research Council’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the process. We wish to thank the following individuals for their review of this report:

Nancy D. Connell, University of Medicine and Dentistry of New Jersey

Armen der Kiureghian, University of California at Berkeley

Charles N. Haas, Drexel University

Bob R. Hillman, Animal Health Matters, LLC

Barbara Johnson, Johnson & Associates, LLC

Joseph B. Kadane, Carnegie Mellon University

James W. Le Duc, University of Texas Medical Branch at Galveston

Linda L. Logan, Texas A&M University

Frederick A. Murphy, University of Texas Medical Branch at Galveston

Mitchell J. Small, Carnegie Mellon University

Gary Smith, University of Pennsylvania

Alan Washburn, Naval Postgraduate School

Alex Winter-Nelson, University of Illinois at Urbana-Champaign

Suggested Citation:"Front Matter." National Research Council. 2012. Evaluation of the Updated Site-Specific Risk Assessment for the National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13418.
×

Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations, nor did they see the final draft of the report before its release. The review of this report was overseen by Dr. Lynn Goldman, George Washington University, and Dr. Ann Arvin, Stanford University School of Medicine. Appointed by the National Research Council, they were responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution.

Suggested Citation:"Front Matter." National Research Council. 2012. Evaluation of the Updated Site-Specific Risk Assessment for the National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13418.
×

Preface

Protecting the nation’s food supply system from foreign animal diseases and protecting our citizenry and the peoples of the world from zoonotic diseases requires advanced research capabilities. That in turn means that there is a need for safe and highly secure laboratories in which to conduct research, develop diagnostic capabilities, and develop vaccines. To that end, the Department of Homeland Security (DHS) is planning to construct a new National Bio- and Agro-Defense Facility (NBAF) in Manhattan, Kansas, to replace the aging Plum Island Animal Disease Center in New York. Once completed, the NBAF will join facilities in Australia, Canada, and Germany to become the fourth functioning biosafety level 4 (BSL-4) agricultural research center in the world to conduct work on large animals.

Foreign animal diseases, such as foot-and-mouth disease (FMD), are ones that are not endemic in the United States and may have a great impact on our agricultural economy if an outbreak occurs in the United States. Many important foreign animal diseases are not zoonotic and cannot be transmitted to humans. Nonetheless, they pose a threat of immense economic impact on American agriculture. Other high-consequence biological threats involving animal and zoonotic diseases will also be studied at the NBAF. About 65% of emerging infectious diseases over the last 50 years have been zoonotic. Studying emerging and new infectious diseases will require capabilities for research with large animals (including BSL-4), and these capabilities will be critical for addressing future unknown threats.

Although there is wide agreement that the country needs a facility like the NBAF, the Government Accountability Office raised the question of whether FMD research can be safely conducted on the mainland of the

Suggested Citation:"Front Matter." National Research Council. 2012. Evaluation of the Updated Site-Specific Risk Assessment for the National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13418.
×

United States. When the decision was made to construct the facility in Manhattan, Kansas, further concerns were raised about building the facility in the middle of Tornado Alley and in the heart of cattle country. Congress thus instructed DHS to conduct a site-specific risk assessment (SSRA) of the potential release of FMD virus from the new facility in Manhattan and the consequent infection, spread, and economic impact. Congress further instructed DHS to seek a review of the risk assessment by a scientific and technical committee of the National Research Council.

DHS and its contractors prepared the site-specific risk assessment and made it public in 2010, and it was reviewed by a committee of the National Research Council. While that committee found the assessment to be a notable first step in an iterative process aimed at identifying and minimizing risk and determining actions that will need to be taken, it nonetheless found the assessment not entirely adequate or valid. Congress subsequently mandated in the Department of Defense and Full-Year Continuing Appropriations Act of 2011 (P.L. 112-10, Sec. 1647) that DHS prepare an updated SSRA (uSSRA) to address concerns raised by the committee’s review.

The uSSRA is based on the 65% design phase planning documents for the facility and the uSSRA is the subject of this committee’s evaluation. The present report is directed to Congress, DHS, stakeholders among the nation’s citizenry, and interested scientific and technical communities.

As noted in the 2009 National Research Council report Science and Decisions: “risk assessment has become a dominant public-policy tool for informing risk managers and the public about the different policy options for protecting public health and the environment. Risk assessment has been instrumental in fulfilling the missions of … federal and state agencies in evaluating public-health concerns, informing regulatory and technologic decisions, setting priorities for research and funding, and developing approaches for cost-benefit analyses.” The purposes of risk assessment in the context of the NBAF are to

•   Provide a systematic and valid approach to evaluating potential accident events and scenarios that might lead to the release of pathogens from the facility in Manhattan, Kansas, and the potential consequences thereof.

•   Include surveillance, response, and mitigation plans for detecting and controlling the spread of disease.

•   Characterize uncertainties in calculated results based on state-of-the-art risk analysis practice.

•   Incorporate peer-reviewed and validated models and scientific data in the analysis.

•   Develop and use a method of estimating the cumulative risk of an FMD infection resulting from an accidental release from the Kansas site over the operating lifetime of the facility.

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×

In the process of reviewing the uSSRA, the committee had the opportunity to hear public comments on the proposed facility and on the risk assessment. These were heard during public sessions in Washington, DC, and during a visit to the proposed site in Manhattan, Kansas, and a tour of the existing Kansas State University Biosecurity Research Institute. The purpose of the site visit was for the committee to better understand specific considerations for the facility. The committee thanks the many members of the public who contributed comments to the evaluation process.

The committee also acknowledges and thanks the U.S. and international experts who volunteered their time to attend early meetings of the committee and to provide their perspectives and experience. They included Soren Alexandersen, Christopher Broder, Charles Haas, Michael Johnson, Thomas Ksiazek, Paul Langevin, Thomas Mettenleiter, Gay Miller, Gregory Paoli, Barrett Slenning, Gregory Smith, Alfonso Torres, Hana Weingartl, and Neal Woollen.

On behalf of the committee, I would like to thank the National Research Council staff who invested great effort and energy in supporting the committee’s work throughout the preparation of this report. I also thank the members of the committee for unselfishly contributing their services and for the collegiality of their efforts.

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

Suggested Citation:"Front Matter." National Research Council. 2012. Evaluation of the Updated Site-Specific Risk Assessment for the National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13418.
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×

Acronyms and Abbreviations

ABSL animal biosafety level
ACRE average crop revenue election
AHR animal handling room
ATR transfer of aerosolized infectious material into the nasal passages of a researcher when researchers are in an AHR
  
BSL biosafety level
  
CDC Centers for Disease Control and Prevention
  
DHS U.S. Department of Homeland Security
  
EIS environmental impact statement
EMAP Emergency Management Accreditation Program
  
FAD foreign animal disease
FMD foot-and-mouth disease
FMDv foot-and-mouth disease virus
  
GAO U.S. Government Accountability Office
  
HEPA high-efficiency particulate air
HeV Hendra virus
HRA human reliability analysis
HSPD-9 Homeland Security Presidential Directive 9
Suggested Citation:"Front Matter." National Research Council. 2012. Evaluation of the Updated Site-Specific Risk Assessment for the National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13418.
×
IATA International Air Transport Association
IOM Institute of Medicine
  
KDE kernel density estimation
KDHE Kansas Department of Health and Environment
  
LD lethal dose
  
MAR material available for release
  
NAADSM North American Animal Disease Spread Model
NAHLN National Animal Health Laboratory Network
NBAF National Bio- and Agro-Defense Facility
NFPA National Fire Protection Association
NiV Nipah virus
NOAA U.S. National Oceanic and Atmospheric Administration
  
OIE World Organization for Animal Health
OTB spill of a shipment of FMDv results in transference to the body in non-containment areas
  
PFU plaque-forming unit
PIADC Plum Island Animal Disease Center
PNNL Pacific Northwest National Laboratory
POE probability of exceedance
  
RIMS II Regional Input-Output Modeling System
  
SCIPUFF Second-order Closure Integrated Puff Model
SOP standard operating procedure
SSRA site-specific risk assessment
  
USAMRIID U.S. Army Medical Research Institute for Infectious Diseases
USDA U.S. Department of Agriculture
USGS U.S. Geological Survey
uSSRA updated site-specific risk assessment
Suggested Citation:"Front Matter." National Research Council. 2012. Evaluation of the Updated Site-Specific Risk Assessment for the National Bio- and Agro-Defense Facility in Manhattan, Kansas. Washington, DC: The National Academies Press. doi: 10.17226/13418.
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Safeguarding U.S. agriculture from foreign animal diseases and protecting our food system require cutting-edge research and diagnostic capabilities. The Department of Homeland Security (DHS) and the U.S. Department of Agriculture (USDA) have embarked on an important mission to replace the aging Plum Island Animal Disease Center (PIADC) with a new facility, the National Bio- and Agro-Defense Facility (NBAF). When operational, this new facility would be the world's fourth biosafety level-4 laboratory capable of large animal research. It would serve as a critical world reference laboratory for identifying emerging and unknown disease threats, and would thus be a critical asset in securing the future health, wealth, and security of the nation.

DHS selected Manhattan, Kansas, as the site for the new NBAF after an extensive site-selection process that involved an environmental impact statement. The Government Accountability Office (GAO) raised concerns about DHS's analysis of the potential spread of foot-and-mouth disease virus (FMDv), one of the most serious foreign animal disease threats. Congress directed DHS to conduct a site-specific risk assessment (SSRA) for the NBAF, instructed the National Research Council (NRC) to independently evaluate the SSRA, and prohibited obligation of NBAF construction funds until the NRC review was complete.

Congress mandated that DHS revise its SSRA to address shortcomings of the 2010 SSRA, directed the NRC to evaluate the updated SSRA (uSSRA), and again prohibited obligation of construction funds until the completion of the second review. The scope for both of these SSRA reports addressed accidental release of pathogens from the NBAF in Manhattan, Kansas and excluded terrorist acts and malicious threats from its risk assessments. Evaluation of the Updated Site-Specific Risk Assessment for the National Bio- and Agro-Defense Facility in Manhattan, Kansas is the evaluation of the final uSSRA.

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