Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas (2010)Board on Life Sciences
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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.
- There is a clear need for a National Bio- and Agro-Defense Facility in the United States. The nation needs an institution to support comprehensive research programs for the study of foreign animal and zoonotic diseases, and to detect, diagnose, and mitigate these diseases through the use of drugs, vaccines, and genomic forensics. Such activities will require the capability to work with all known threat agents, multiple pathogen introductions, and emerging and unknown disease threats.
- The team conducting the risk assessment should be applauded for its effort in conducting an extensive risk assessment in such a short period of time. Although the committee expresses major concerns about the validity of some of the risk assessment's conclusions, the work that was completed constitutes a huge step forward compared with previous risk assessments of its kind and should be viewed as a solid starting point.
- The site-specific risk assessment's qualitative risk assessment regarding the most dangerous pathogens was inadequate. The qualitative risk assessment failed to fully consider the characteristics of the pathogens and the risks of working with biosafety level 4 pathogens in large animal facilities, which will be a new type of laboratory capability for the United States. Furthermore, it is insufficient to use biosafety level 3 pathogens to predict risks associated with biosafety level 4 pathogens that are zoonotic and for which no treatment is available.
- The site-specific risk assessment shows that constructing the proposed National Bio- and Agro-Defense Facility in Manhattan, Kansas, carries substantial risks of a pathogen release with potentially significant economic, health, and national security impacts. The risk assessment indicates that the probability of a foot-and-mouth disease infection resulting from a laboratory release approaches 70 percent over the expected 50 year life span of the facility with an economic impact of $9-50 billion. The risk assessment lacks evidence to support the conclusion that operating the facility in Manhattan, Kansas "overall brings extremely low risk."
- The site-specific risk assessment could well have underestimated the risk of a pathogen release and transmission from the proposed National Bio- and Agro-Defense Facility in Manhattan, Kansas, and the consequences of such a release. In many scenarios, the numbers probably represent conservative estimates of risk.
- The site-specific risk assessment overlooked some critical issues that could significantly elevate the risk of accidental release and spread of pathogens. These include risks related to the facility's proximity to Kansas State University with its large human population, sick and susceptible animals at the College of Veterinary Medicine, and other nearby research facilities. The risk assessment also neglected to consider the maintenance and daily cleaning of animal pens, which would result in aerosol emissions much greater than were assumed and would likely lead to significantly increased risks of infection through fomites (contaminated inanimate objects) and airborne pathways.
- For foot-and-mouth disease virus, the committee agrees with the site-specific risk assessment's conclusion that long-distance plume transport will likely be less important than the near-site exposure of cattle and other livestock. The facility's close proximity to livestock at Kansas State University's College of Veterinary Medicine, sales barns, and cow-calf operations, and the transport of livestock across neighboring states will serve as major factors in spreading and amplifying a foot-and-mouth disease outbreak throughout the United States.
- The site-specific risk assessment had several methodological flaws related to dispersion modeling, and epidemiological modeling. The committee found that many of the assumptions used for the model parameters were arbitrary and subject to user bias. Though there are substantial gaps in data for predicting the nature and scope of scenarios used in the modeling scenarios, data from recent foot-and-mouth disease virus events and laboratory escapes could have provided valuable lessons for the risk assessment in understanding realistic expectations for mitigation measures and disaster preparation plans. The economic modeling was conducted with appropriate methods; however, the epidemiological estimates used as inputs were flawed.
- The committee agrees with the site-specific risk assessment's conclusion that early detection and response can limit the impact of a foot-and-mouth disease virus release from the facility, but is concerned that the risk assessment does not describe how the facility could rapidly detect such a release. Early detection is critical for limiting the spread of infection, therefore it will be important to develop extensive real-time surveillance for foot-and-mouth disease virus and other pathogens being worked on at the facility before it becomes operational.
- The site-specific risk assessment lacks a comprehensive mitigation strategy developed with stakeholder input for addressing major issues related to pathogen release, and it does not provide realistic plans for how federal, state, and local authorities would effectively respond to and control a pathogen release. In particular, the committee was concerned about the lack of clinical isolation facilities and world-class infectious disease clinicians experienced in diagnosing and treating laboratory staff or communities exposed to biosafety level 4 pathogens. Furthermore, the Manhattan, Kansas region is a hub of animal movement for the entire United States, but mitigation strategies failed to address the consequences of the movement of infected animals across the country and outbreaks of such magnitude.
- Human error will be the most likely cause of an accidental pathogen release, and therefore safe practices are of paramount importance. To enhance safe operations and reduce the risk of human error, personnel will need adequate ongoing training, education, and evaluation of skills.
- Given that the cost of a release would be very high, the facility will need to be engineered beyond accepted standards to an exceptionally high level of biosafety and biosecurity. The committee is seriously concerned about current design plans that, for reasons of practicality and cost-savings, potentially compromise safety measures.