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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

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06/21/2012

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T
he Department of Homeland Securityand the U.S. Depart-ment of Agriculture haveembarked on an importantmission to replace theaging Plum Island AnimalDisease Center, located off the coast of Long Island, New York. The newfacility, called the NationalBio- and Agro-DefenseFacility, is envisioned as astate-of-the-art, high biocontainment facility that would bring newcapabilities for disease detection, diagnostics,and vaccine development to the United States.When operational, the National Bio- and Agro-Defense Facility would conduct research andtraining activities with large animals infectedwith biosafety level 4 pathogens such asfoot-and-mouth diseasevirus—work that is impor-tant to understanding newand emerging foreignanimal diseases (agricul-tural animal diseases caused by an agent that does notoccur naturally in theUnited States) and zoonoticdiseases (which are trans-missable between animalsand humans).The Department of Homeland Security selectedManhattan, Kansas, as the site for the new National Bio- and Agro-Defense Facility after anextensive site-selection process. The Government
Accountability Ofce raised concerns about the
Department of Homeland Security’s analysis of the potential spread of foot-and-mouth diseasevirus, one of the most serious foreign animaldisease threats. Congress subse-quently directed the Department of Homeland Security to conduct a
site-specic risk assessment for the
 National Bio- and Agro-DefenseFacility, instructed the NationalResearch Council to independently
evaluate the site-specic risk 
assessment, and prohibited
The updated site-specic risk assessment for the National Bio- and Agro-Defense Facility is asubstantial improvement over the original 2010 site-specic risk assessment, but is still inad
-
equate in fully characterizing the risks associated with operating a high biocontainment facilityin Manhattan, Kansas. Many of the shortcomings identied in a 2010 National ResearchCouncil report have been addressed in this updated assessment and more conventional risk analysis methods were used. However, some risk analysis methods were misinterpreted ormisapplied when executed, and there were some questionable and inappropriate assumptionsmade to develop estimates of the probabilities, frequencies, and amounts of release of foot-and-mouth disease and other pathogens. As a result, the committee concludes that the updatedsite-specic risk assessment is technically inadequate in critical respects and is an insufcientbasis on which to judge the risks associated with the proposed National Bio- and Agro-DefenseFacility in Manhattan, Kansas.
Evaluation of the Updated Site-Specic RiskAssessment for the National Bio- and Agro-Defense Facility in Manhattan, Kansas
Biosafety levels
refer to specic combinations of workpractices, safety equipment, and facilities designed to minimizethe exposure of workers and the environment to infectiousagents.
Biosafety level 4 pathogens
pose a high risk of life-threatening disease for which there is no vaccine or therapy.
Centers for Disease Control and Prevention Glossary/ http://www.cdc.gov
Credit: USDA/Peggy Greb
 
obligation of National Bio- and Agro-Defense Facilityconstruction funds until the National ResearchCouncil review was complete.A previous National Research Council report,
released in 2010, found that the site-specic risk assessment was inadequate due to awed methods and
assumptions which potentially underestimated the risk of an accidental foot-and-mouth disease virus releasefrom the National Bio- and Agro-Defense Facility inManhattan, Kansas. In response, Congress againwithheld construction funds and mandated that theDepartment of Homeland Security update its site-
specic risk assessment to address shortcomings, and
asked that the National Research Council evaluate the
updated site-specic risk assessment.
 Meeting the Congressional Mandate
The updated site-specic risk assessment is a substan
-
tial improvement over the original 2010 site-specic
risk assessment, addressing many shortcomings
identied in the previous National Research Council
report. Despite these improvements, the report’s
authoring committee nds that the shortcomings inthe updated site-specic risk assessment likely
underestimate the risks of pathogen release andinfection and inadequately characterize the uncertain-ties of these risks.
The 2010 site-specic risk assessment showed that
for the two greatest release scenarios, there is nearly a70 percent probability that a release of foot-and-mouthdisease virus could result in an infection outside thelaboratory over the 50-year lifespan of the NationalBio- and Agro-Defense Facility in Manhattan, Kansas.
In contrast, the updated site-specic risk assessment
concludes that the cumulative probability for 142 risk events leading to an accidental release of foot-and-mouth disease virus over 50 years is about 0.11 percent(or a 1 in 46,000 chance per year). Improvements in thedesign of the facility may account for some risk reduction, but the committee believes that questionableand inappropriate assumptions used in the updated
site-specic risk assessment lead to articially lower 
estimates of the probabilities and amounts of pathogen
released. Because the updated site-specic risk assess
-ment contains inconsistent information, it has been
difcult to interpret data or to reconstruct risk 
scenarios in order to determine the degree to whichrisks were underestimated.
These deciencies and others lead the report’s
authoring committee to conclude that the updated
site-specic risk assessment continues to be inad
-equate in characterizing the risks associated withoperating the National Bio- and Agro-Defense Facilityin Manhattan, Kansas.
The Use and Application of Risk Models
The updated site-specic risk assessment uses a
quantitative modeling framework that includes the
identication of risk scenarios, total calculation of risk 
of all events, and uncertainty analysis— an importantadvance over the 2010 risk assessment. The committee
identied concerns about how the framework was
implemented and found that methods were inconsis-tently applied across the various sections of the
updated site-specic risk assessment and that probabi
-listic dependencies in calculating risk scenarios wereignored, resulting in potentially serious underestima-tions of total risk and incorrect ranking of risk contributors.A critical part of risk analysis is characterizing the
uncertainty of the results. The updated site-specic
risk assessment’s characterization and assessment of uncertainties was incomplete and inconsistent, leadingto a false sense of precision and limiting its utility for decision-making.
The updated site-specic risk assessment uses
very low rates caused by human error that are notsupported by published literature or empirical experi-
ence. The 2010 site-specic risk assessment concluded
that human error would be the most likely cause of release, and the previous National Research Council
report agreed with that conclusion. Little justication
is provided for the assumption that the rate of error for  National Bio- and Agro-Defense Facility workers will be several times less than that of similarly skilled
 Box 1. What is Foot-and-Mouth Disease?
Foot-and-mouth disease is a highly contagious and deadlyviral disease of cloven-hoofed animals such as cows andsheep and constitutes a major threat to the livestock industry. The United States has been free of foot-and-mouth-disease since 1929, and research on livefoot-and-mouth disease virus has not been permitted on theU.S. mainland since 1937.
 Box 2 The Proposed Site of the National Bio- and  Agro-Defense Facility
The proposed site of the National Bio- and Agro-DefenseFacility is on the Kansas State University campus, bordering the Biosecurity Research Institute and adjacentto the College of Veterinary Medicine. About 10 percentof the nation’s cattle reside within a 200-mile radius of Manhattan, Kansas —and approximately 45 percent of thenation’s cattle reside in the seven states modeled as the
expected impact area in the updated site-specic risk 
assessment. This makes the region a major hub for transportation of cattle and other livestock for the entireUnited States.
 
workers in similar facilities, and it does not accountfor the possibility that routine tasks can be associatedwith high failure rates even when tasks are carried out by highly trained workers.
 Model Parameters and Assumptions
The committee questioned the input data and param-
eters used in the updated site-specic risk assessment,
noting that underestimates of parameter values could
shift nal results by many times more. In several places, the updated site-specic risk assessment did
not describe the approaches used to ensure a thoroughreview of parametric inputs, making it impossible to
determine whether the scientic literature and other 
information used to support risk assessment assump-tions have been thoroughly evaluated. Many parameter estimates depended on outdated referencesor on only a single reference. At times, the lowestresulting risk input factors were selected, despite theavailability of other data yielding higher risk.
 Epidemic Modeling 
The updated site-specic risk assessment estimated
the consequences of a potential release of foot-and-mouth disease virus from the proposed NationalBio- and Agro-Defense Facility using the NorthAmerican Animal Disease Spread Model in conjunc-tion with data, statistical methods, and references
from the scientic literature. Outputs from the model
were used to evaluate the impact of the spread of foot-and-mouth disease virus through Kansas and intosix adjoining states in different release events.
The updated site-specic risk assessment addressed
some previous criticisms of its epidemic modeling, but
there are still signicant limitations in model capabili
-ties and available data. These, along with some overlyoptimistic assumptions about response resources andcapacities anticipated to be available when the facilityopens, lead to underestimates of the magnitude, spread,and the duration of a foot-and-mouth disease outbreak from the proposed facility.
 Economic Analysis
The updated site-specic risk assessment includes a
comprehensive economic analysis that uses models todetermine the impact of factors such as depopulatinglivestock during an outbreak and reduced exports of livestock products on market prices, quantities,economic welfare, and expenditure.Although the methods used for the economic
analysis are appropriate, sufcient information to
replicate the results or to assess whether the analysiswas properly executed was not provided. Under-estimates of the magnitude, spread, and duration of a foot-and-mouth disease outbreak from the epidemicmodeling were carried over into the economic model,likely leading to an underestimate of the economicconsequence of a foot-and-mouth disease virus escapefrom the facility.
Treatment of Natural Hazards
The updated site-specic risk assessment concludes
that a release caused by a natural hazard, such as atornado or earthquake, is 20 times more likely than arelease caused by an error or failure during normalfacility operations. The committee questions this
conclusion and nds that the updated site-specic risk 
assessment overestimates the likelihood of a releasecaused by a natural hazard. Although Kansas is proneto high winds due to tornadoes, it is a region of rela-tively low seismicity, and furthermore, the lowstructural fragility (strong resistance) of the proposedfacility design is not taken into account.
 Surveillance, Response, Mitigation
Surveillance, detection, and emergency responsecapabilities (such as the availability of vaccines) arecritical for mitigating the effects of an outbreak, but
are not yet in place. The updated site-specic risk 
assessment modeled disease release mitigation,response, and detection based on Department of Homeland Security and United States Department of 
Agriculture expectations for signicantly improved
 plans, programs, and strategies to be implemented bythe time the facility opens in 2020.However, there was no indication that the neces-sary science-based capabilities for foot-and-mouthdisease surveillance and response would be fullydeveloped and implemented by the time the proposed2020 opening of the facility. If they are not, the risksand consequent impacts of a disease outbreak will begreater than estimated.
 Personnel Training 
The updated site-specic risk assessment fails to
include Department of Homeland Security plans for  personnel training in security, laboratory procedures,and emergency response as required by the PublicHealth Security and Bioterrorism Preparedness andResponse Act of 2002. Those plans are critical for ensuring safe operations at the National Bio- andAgro-Defense Facility and for mitigating an accidentalfoot-and-mouth disease virus release from the labora-tory. Exclusion of such information leads thecommittee to believe that preparations for the require-ment have not been fully addressed by the Departmentof Homeland Security. This raises the possibility thatrisks that needed to have been considered were never 

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