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Bio- and Agro-Defense Facility, Report in Brief

Bio- and Agro-Defense Facility, Report in Brief

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Published by earthandlife
A new report from the National Research Council finds that the Department of Homeland Security’s site-specific assessment of risks associated with locating the National Bio- and Agro-Defense Facility in Manhattan, Kansas, is incomplete.

The new biocontainment laboratory would serve as the linchpin in protecting U.S. agriculture from foreign animal disease threats such as foot-and-mouth disease. However, concerns about the methods and analysis used to select the facility’s location prompted Congress to request that the Department of Homeland Security complete a site-specific biosecurity and biosafety mitigation risk assessment before construction funds could be obligated.

This report evaluates the risk assessment’s methods, the facility design plans, and disease outbreak mitigation strategies. Although the risk assessment drew many legitimate conclusions, the committee found it did not adequately identify the unique risks associated with locating the facility next to Kansas State University, nor did it properly account for risks associated with work in the highest possible level of bio-containment.
A new report from the National Research Council finds that the Department of Homeland Security’s site-specific assessment of risks associated with locating the National Bio- and Agro-Defense Facility in Manhattan, Kansas, is incomplete.

The new biocontainment laboratory would serve as the linchpin in protecting U.S. agriculture from foreign animal disease threats such as foot-and-mouth disease. However, concerns about the methods and analysis used to select the facility’s location prompted Congress to request that the Department of Homeland Security complete a site-specific biosecurity and biosafety mitigation risk assessment before construction funds could be obligated.

This report evaluates the risk assessment’s methods, the facility design plans, and disease outbreak mitigation strategies. Although the risk assessment drew many legitimate conclusions, the committee found it did not adequately identify the unique risks associated with locating the facility next to Kansas State University, nor did it properly account for risks associated with work in the highest possible level of bio-containment.

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Published by: earthandlife on Dec 02, 2010
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12/01/2011

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P
rotecting our nation’sfarms, animals,economy, and foodsupply from a foreignanimal or zoonotic diseaseoutbreak is an importantchallenge—one that can beovercome with improveddisease detection, diagnos-tics, and the developmentof new vaccines. To ful
llthe obligations underHomeland SecurityPresidential Directive 9 tosupport this critical mission of basic and appliedresearch, the Department of Homeland Securitywill build a state-of-the-art laboratory to replacethe aging Plum Island Animal Disease Center,which is located off the coast of Long Islandin New York. The new facility will be called theNational Bio- and Agro-Defense Facility, and itwill differ from otherhigh-containmentlaboratories in that itwill be capable of conducting researchusing large animals,such as cattle and swine,and will be equipped forwork on some of themost dangerous patho-gens, including the virusthat causes foot-and-mouth disease.On the basis of itsenvironmental impact statement and its threatrisk assessment, the Department of HomelandSecurity selected the Manhattan, Kansas site asthe proposed location to construct and operatethe National Bio- and Agro-Defense Facility;however, the Government AccountabilityOf 
ce raised concerns about the adequacy of the analysis and methods used todetermine this site. In response,Congress instructed the Department of Homeland Security to complete asite-speci
c biosecurity and biosafetyrisk assessment of the proposed facilitybefore construction funds could beobligated. The legislation also asked theNational Research Council to conductan independent evaluation of the site-speci
c risk assessment to determine itsadequacy and validity.
The Department of Homeland Security has selected Manhattan, Kansas, as the location for anew, state-of-the-art research facility that will study foreign animal and zoonotic diseases.This report evaluates the site-speci
c risk assessment conducted by the Department of Homeland Security, and
nds that the risk assessment did not adequately identify the uniquerisks associated with this location or properly account for risks and impacts associated withwork on the most dangerous pathogens.
Evaluation of a Site-Speci
c Risk Assessment forthe Department of Homeland Security’s PlannedNational Bio- and Agro-Defense Facilityin Manhattan, Kansas
A
foreign animal disease 
is an animal disease causedby an agent that does not occur naturally in the UnitedStates. The disease is limited to agricultural animals(NRC, 2005).A
zoonotic disease or infection 
is transmissiblebetween animals and humans. Zoonoses are a publichealth concern for people, and may also affect animalhealth and thus prevent the ef 
cient production of foodanimals and create obstacles to international trade inanimals and animal products (WHO, 2008; IOM andNRC, 2009).
Credit: USDA Agricultural Research Service/Scott Bauer
 
Evaluation of the Assessment
The report’s authoring committee commendedthe Department of Homeland Security for performingthe site-speci
c risk assessment within a remark-ably short time frame, and found that the risk assessment used appropriate methods and mademany legitimate conclusions. However, thecommittee determined that the site-speci
c risk assessment is not entirely adequate or valid becauseof several shortcomings with respect to the potentialrisks and impact scenarios and some limitations inexecuting and analyzing the data. The risk assess-ment did not account for the overall risks associatedwith operating the facility in Manhattan, Kansas,nor did it account for the risks associated withwork on the most dangerous pathogens in a largeanimal facility.Overall, the Department of Homeland Security’ssite-speci
c risk assessment concluded that thethreat of a pathogen release from the facilityresulting in a disease outbreak is “extremely low,”compared to the risk of an outbreak from an outsidesource. The committee observed that no estimateson external sources of pathogen introduction werepresented, making this comparison invalid. The risk assessment estimates provided by the Department of Homeland Security show that there is at least a 70percent chance over the facility’s 50-year lifespan of foot-and-mouth disease virus being released outsidethe laboratory and causing an infection—a level of risk that cannot be considered low. The risk assess-ment also estimated the economic impacts of such anoutbreak at $9-$50 billion. The committee found thatbecause the risk assessment contained assumptionsthat were arbitrary and subject to user bias formodeling aerosol dispersal of disease agents, torna-does, and the scope and extent of disease spread,many scenarios were potentially overoptimistic andcould well have led to major underestimations of therisks and subsequent costs related to an outbreak.The risk assessment proposed some mitigationstrategies, but did not calculate the risk reductionlevels for such proposed actions. With the informa-tion provided, the committee could only commenton the probabilities and costs as presented in therisk assessment, and the committee was not able tospeculate on how risk reduction practices may impactthe overall risk of operating the National Bio- andAgro-Defense Facility in Manhattan, Kansas.Outlined below are the four main elements of the risk assessment, along with the key points thecommittee identi
ed in each section.
Estimating the Chance of a PathogenRelease
The risk assessment considered the majorpathways by which a pathogen could be released:via aerosols, fomites (contaminated objects), liquidwaste, and solid waste. The committee agreed withthe site-speci
c risk assessment’s conclusion thathuman error is the most likely cause of an accidentalpathogen release – but found certain facility charac-teristics were not considered that would signi
cantlyelevate the risk of accidental pathogen release. Forexample, the daily maintenance and cleaning of animal pens in the facility would create an aerosolof pathogens more frequently than was accountedfor in the risk assessment, and could increase therisk of pathogens being carried outside throughoverburdening the facility’s air
ltration system orby laboratory workers spreading contamination.Even if only one room in the facility were used forfoot-and-mouth disease experiments, cleaning theroom daily would produce the equivalent of 365spills each year that could potentially lead to afoot-and-mouth disease virus infection and outbreak.In other parts of the risk assessment, lessonslearned from past animal disease outbreaks were notapplied to estimate the risk of pathogen escape anddisease spread. The site-speci
c risk assessmentestimated that the facility’s liquid waste decontami-nation system would fail just once every 2.1 millionyears. However, such a failure was the cause of the2007 release of foot- and-mouth disease virus in theUnited Kingdom. Another incident occurred in June1999 at the National Centre for Foreign AnimalDisease in Winnipeg, Canada before the facility washandling live pathogens: a batch of untreatedwastewater was accidentally released into the localsewage system. Perhaps of greater signi
cance isthat in the past 50 years, there have been 15 docu-mented releases of foot-and-mouth disease virusfrom laboratories around the world, including onefrom Plum Island.
Predicting the Extent of Disease Spread
While pathogen release is an inherent risk forany high-containment laboratory, the degree of resulting infection, spread, and impact will bestrongly related to a laboratory’s location. TheDepartment of Homeland Security’s risk assessmentnoted that tornado conditions could carry air-bornepathogens long distances from the facility in theevent of a release; however, this was a less criticalpathway for foot- and-mouth disease virus spread
 
than the near-site exposure of cattle. About9.5 percent of the U.S. cattle population is locatedwithin 200 miles of the proposed facility. The regionalso serves as a hub for livestock transportation forthe whole United States, meaning that infectedanimals could easily enter the transportation chain,allowing the infection to spread quickly across greatdistances from the initial focus of the outbreak.The risk assessment also overlooked someimportant site-speci
c factors that could elevate therisks of spread of a disease pathogen originatingfrom the laboratory. For example, the proximity of the proposed laboratory to other animal facilities is acause for concern. The laboratory will be adjacent tothe Kansas State University’s College of VeterinaryMedicine, which treats sick and disease-susceptibleanimals. Once the animals return home with theirowners, they could serve as a conduit for diseasespread. This is in stark contrast to the Plum Islandresearch facility, which is located on an otherwiseuninhabited island with limited visitor access.
Developing Mitigation Strategies
Because the most probable cause of pathogenrelease identi
ed by the risk assessment is humanerror, safe practices are of paramount importance inmitigating a disease outbreak. To reduce the risk of human error, the committee agrees that key NationalBio- and Agro-Defense Facility personnel wouldneed ongoing training, education, and evaluation of skills, together with zero tolerance for deviationsfrom biosafety standards and practices recom-mended by the Centers for Disease Control andPrevention and the U.S. Department of Agriculture.To minimize the impact of a pathogen outbreak,it is essential to have mitigation strategies in placewith plans to treat infected people and animals andmeasures to limit the spread of disease. Thecommittee found that the mitigation strategiesdescribed in the risk assessment did not realisticallyestimate current or future capabilities for howfederal, state, tribal, and local authorities wouldrespond to and control a pathogen release.For example, because the proposed researchfacility will handle dangerous zoonotic pathogensthat can cause severe illness and death in humans,and for which there is no available treatment, theproximity to adequate clinical facilities is important.The risk assessment identi
ed the MercyRegional Health Center as the major medical centerin the area. However, the committee found that thehealth center does not have the appropriate clinicalisolation facilities, diagnostic laboratory capability,or infectious disease clinicians experienced indiagnosing and treating patients exposed to the mostdangerous pathogens, to meet the community’sneeds in developing response measures.Epidemiological studies were used to model theoutcomes of disease outbreaks using various mitiga-tion strategies, but in some cases the inputs to themodels were unrealistic. For example, one mitigationstrategy assumed that if a disease outbreak occurred, workers would be able to cull and bury orburn 120 herds of farm animals per day, destroytheir feed, and thoroughly clean and disinfect thepremises to prevent the spread of disease. Culling onthis scale would place considerable logisticaldemands on personnel and equipment, and mostlikely would not even be possible with militaryintervention. The committee also questioned overlyoptimistic estimates of the amount of time it wouldtake for disease symptoms to be recognized andreported as a disease outbreak.Furthermore, the modeling did not consider theimpacts of a foot-and-mouth disease virus epidemicon the entire nation. Instead, epidemiological andeconomic impacts were modeled in only sevenstates, selected based on their swine and cattlepopulations. The committee found that limiting thestudy in this way means that it is unlikely to accu-rately re
ect the impact of an epidemic. Currentlivestock transportation and management practicesmean that infected animals could easily be trans-ported beyond the seven states, and even acrosscountry borders to and from Canada or Mexico. Thecommittee also observed that states with loweranimal populations may actually have the highestnumbers of livestock sales barns and less stringentanimal inspection standards than other states, sothat the rate of infection and disease spread couldhave been underestimated.

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