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Evaluation of the Updated Site-Specific Risk Assessment for the National Bio- and Agro-Defense Facility in Manhattan, Kansas
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 ACADMIES
THE NATIONAL ACADEMIES PRESS
Washington, D.C.
www.nap.edu
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Evaluation of the Updated Site-Specific Risk Assessment for the National Bio- and Agro-Defense Facility in Manhattan, Kansas
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
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Additional copies of this report are available for sale from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http://www.nap.edu/.
Copyright 2012 by the National Academy of Sciences. All rights reserved.
Printed in the United States of America.
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Evaluation of the Updated Site-Specific Risk Assessment for the National Bio- and Agro-Defense Facility in Manhattan, Kansas
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
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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
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BOARD ON LIFE SCIENCES
KEITH R. YAMAMOTO (Chair), University of California, San Francisco, CA
BONNIE L. BASSLER, Princeton University, Princeton, NJ
VICKI L. CHANDLER, Gordon and Betty Moore Foundation, Palo Alto, CA
SEAN EDDY, HHMI Janelia Farm Research Campus, Ashburn, VA
MARK FITZSIMMONS, John D. and Catherine T. MacArthur Foundation, Chicago, IL
DAVID R. FRANZ, Former Cdr USAMRIID, Frederick, MD
LOUIS J. GROSS, University of Tennessee, Knoxville, TN
RICHARD A. JOHNSON, Arnold & Porter, LLC, Washington, DC
CATO T. LAURENCIN, University of Connecticut Health Center, Farmington, CN
ALAN I. LESHNER, American Association for the Advancement of Science, Washington, DC
BERNARD LO, University of California, San Francisco, CA
ROBERT M. NEREM, Georgia Institute of Technology, Atlanta, GA
MURIEL E. POSTON, Skidmore College, Saratoga Springs, NY
ALISON G. POWER, Cornell University, Ithaca, NY
MARGARET RILEY, University of Massachusetts, Amherst, MA
BRUCE W. STILLMAN, Cold Spring Harbor Laboratory, Cold Spring Harbor, NY
CYNTHIA WOLBERGER, Johns Hopkins University School of Medicine, Baltimore, MD
MARY WOOLLEY, Research!America, Alexandria, VA
Staff
FRANCES E. SHARPLES, Board Director
JO L. HUSBANDS, Scholar/Senior Project Director
JAY B. LABOV, Senior Scientist/Program Director for Biology Education
KATHERINE W. BOWMAN, Senior Program Officer
INDIA HOOK-BARNARD, Senior Program Officer
MARILEE K. SHELTON-DAVENPORT, Senior Program Officer
KEEGAN SAWYER, Program Officer
BETHELHEM M. BANJAW, Financial Associate
ORIN E. LUKE, Senior Program Assistant
CARL-GUSTAV ANDERSON, Program Associate
SAYYEDA AYESHA AHMED, Senior Program Assistant
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BOARD ON AGRICULTURE AND NATURAL RESOURCES
NORMAN R. SCOTT (Chair),1 Cornell University, Ithaca, NY
PEGGY F. BARLETT, Emory University, Atlanta, GA
HAROLD L. BERGMAN, University of Wyoming, Laramie, WY
RICHARD A. DIXON,2 Samuel Roberts Noble Foundation, Ardmore, OK
DANIEL M. DOOLEY, University of California, Oakland, CA
JOAN H. EISEMANN, North Carolina State University, Raleigh, NC
GARY F. HARTNELL, Monsanto Company, St. Louis, MO
GENE HUGOSON, Global Initiatives for Food Systems Leadership, St. Paul, MN
MOLLY M. JAHN, University of Wisconsin-Madison, WI
ROBBIN S. JOHNSON, Cargill Foundation, Wayzata, MN
A.G. KAWAMURA, Solutions from the Land, Washington, DC
KIRK C. KLASING, University of California, Davis, CA
JULIA L. KORNEGAY, North Carolina State University, Raleigh, NC
VICTOR L. LECHTENBERG, Purdue University, West Lafayette, IN
JUNE BOWMAN NASRALLAH,2 Cornell University, Ithaca, NY
PHILIP E. NELSON, Purdue University, West Lafayette, IN
KEITH PITTS, Marrone Bio Innovations, Davis, CA
CHARLES W. RICE, Kansas State University, Manhattan, KS
HAL SALWASSER, Oregon State University, Corvallis, OR
ROGER A. SEDJO, Resources for the Future, Washington, DC
KATHLEEN SEGERSON, University of Connecticut, Storrs, CN
MERCEDES VAZQUEZ-AÑON, Novus International, Inc., St. Charles, MO
Staff
ROBIN A. SCHOEN, Board Director
AUSTIN J. LEWIS, Senior Program Officer
EVONNE P.Y. TANG, Senior Program Officer
CAMILLA YANDOC ABLES, Program Officer
KARA N. LANEY, Program Officer
PEGGY TSAI, Program Officer
JANET M. MULLIGAN, Senior Program Associate for Research
RUTH S. ARIETI, Research Associate
KAREN L. IMHOF, Administrative Coordinator
KATHLEEN REIMER, Senior Program Assistant
1Member of the National Academy of Engineering
2Member of the National Academy of Sciences
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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
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Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations, nor did they see the final draft of the report before its release. The review of this report was overseen by Dr. Lynn Goldman, George Washington University, and Dr. Ann Arvin, Stanford University School of Medicine. Appointed by the National Research Council, they were responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution.
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Preface
Protecting the nation’s food supply system from foreign animal diseases and protecting our citizenry and the peoples of the world from zoonotic diseases requires advanced research capabilities. That in turn means that there is a need for safe and highly secure laboratories in which to conduct research, develop diagnostic capabilities, and develop vaccines. To that end, the Department of Homeland Security (DHS) is planning to construct a new National Bio- and Agro-Defense Facility (NBAF) in Manhattan, Kansas, to replace the aging Plum Island Animal Disease Center in New York. Once completed, the NBAF will join facilities in Australia, Canada, and Germany to become the fourth functioning biosafety level 4 (BSL-4) agricultural 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
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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
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Contents
ACRONYMS AND ABBREVIATIONS
SUMMARY
1 INTRODUCTION
Unique Capabilities and Risks Associated with the NBAF
Proposed Site in Manhattan, Kansas
Previous Assessments
Congressional Mandate and Statement of Task
Committee’s Approach to its Task
Organization of the Report
References
2 EVALUATION OF DESIGN, OPERATIONS, AND RESPONSE PLANNING AS RELATED TO THE RISK ASSESSMENT
Design Plans
Standard Operating Procedures, Personnel Training, and Emergency Response Planning
Reference
3 EVALUATION OF RISK APPROACH AND CALCULATIONS
Risk Modeling Framework
Application of Risk Methods in the uSSRA
Specific Cross-Cutting Issues
Input Data and Parameter Estimates
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Concerns About Quantitative Analysis Practices
References
4 EVALUATION OF ACCIDENT EVENT MODELING
Overview of Methods for Accident Event Modeling
Commentary
Terminology
Logic Errors and Event Trees
Development of Failure Probabilities and Reduction Factors
General Findings on Data Inputs
Modeling of Catastrophic Natural Hazards
Tornadoes
Earthquakes
References
5 EVALUATION OF FATE AND TRANSPORT MODELING
Modifications in Use of the Model and Parameters
Shortcomings in the Application of SCIPUFF
Shortcomings in Modeling Airborne Spread in NAADSM
References
6 EVALUATION OF EPIDEMIC MODELING
Overview of Methods and Analysis
Summary Assessment
Methodological Limitations
References
7 EVALUATION OF ECONOMIC MODELING
Overview of Methods and Analysis
Inaccurate Descriptions of Methods and Analysis
Insufficient Information Provided to Verify Results
Partial Equilibrium Model Analysis
Regional Model Analysis
Non-Indemnification Costs
Summary
References
8 EVALUATION OF BIOSAFETY LEVEL 4 ASSESSMENT
Inadequacy of the Semi-Quantitative Approach
Concerns About BSL-4 Analysis
Concerns About Use of Methods and Models
References
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9 OVERALL ASSESSMENT, FINDINGS, AND CONCLUSIONS
Overall Assessment
Findings
Limited Applicability of the Updated Site-Specific Risk Assessment
Conclusions
References
APPENDIXES
A Committee Biosketches
B Meeting Agendas and Lists of Public Participants
BOXES
1-1 Findings of the 2010 National Research Council Review of the DHS Site-Specific Risk Assessment for the National Bio- and Agro- Defense Facility
1-2 Department of Defense and Full Year Continuing Appropriations Act, 2011
1-3 Statement of Task
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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
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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
