Evaluation Of The Updated Site Specific Risk Assessment For The National Bio And Agro Defense Facility In Manhattan Kansas

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.

Congress requested that the U.S. Department of Homeland Security (DHS) produce a site-specific biosafety and biosecurity risk assessment (SSRA) of the proposed National Bio- and Agro-Defense Facility (NBAF) in Manhattan, Kansas. The laboratory would study dangerous foreign animal diseases-including the highly contagious foot-and-mouth disease (FMD), which affects cattle, pigs, deer, and other cloven-hoofed animals-and diseases deadly to humans that can be transmitted between animals and people. Congress also asked the Research Council to review the validity and adequacy of the document. Until these studies are complete, Congress has withheld funds to build the NBAF. Upon review of the DHS assessment, the National Research Council found "several major shortcomings." Based on the DHS risk assessment, there is nearly a 70 percent chance over the 50-year lifetime of the facility that a release of FMD could result in an infection outside the laboratory, impacting the economy by estimates of $9 billion to $50 billion. The present Research Council report says the risks and costs of a pathogen being accidently released from the facility could be significantly higher. The committee found that the SSRA has many legitimate conclusions, but it was concerned that the assessment does not fully account for how a Biosafety-Level 3 Agriculture and Biosafety-Level 4 Pathogen facility would operate or how pathogens might be accidently released. In particular, the SSRA does not include important operation risks and mitigation issues, such as the risk associated with the daily cleaning of large animal rooms. It also fails to address risks that would likely increase the chances of an FMD leak or of the disease's spread after a leak, including the NBAF's close proximity to the Kansas State University College of Veterinary Medicine clinics and KSU football stadium or personnel moving among KSU facilities.

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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This environmental impact statement presents an evaluation of the DHS proposal to site, construct and operate the NBAF. Operation of the NBAF as a biosafety level-3 (BSL-3) and BSL-4 research facility would allow basic and advanced research, diagnostic testing and validation, countermeasure development, and diagnostic training for addressing high-consequence livestock diseases to U.S. agriculture and public health. Six alternative NBAF sites are evaluated in the DEIS: Athens, Georgia; Manhattan, Kansas; Flora, Mississippi; Plum Island, New York; Butner, North Carolina; and, San Antonio, Texas. The No Action Alternative of not constructing and operating the NBAF is also analyzed.

The agricultural and food infrastructure of the United States is potentially susceptible to terrorist attack using biological pathogens. In addition to the impacts of such an attack on the economy, some animal diseases could potentially be transmitted to humans. (These diseases are known as zoonotic diseases.) Scientific and medical research on plant and animal diseases may lead to the discovery and development of new diagnostics and countermeasures, reducing the risk and impact of a successful terrorist attack. To safeguard the United States against animal disease, Congress has appropriated funds to the U.S. Department of Agriculture (USDA) to engage in research at the Plum Island Animal Disease Center (PIADC), off the coast of New York, on animal diseases not native to the United States. When creating the Department of Homeland Security (DHS) in 2003, Congress transferred the PIADC facility from USDA to DHS. Both USDA and DHS, in cooperation with USDA, conduct foreign animal disease research at PIADC, but PIADC has been identified as outdated and too limited to continue as the primary facility for this research. Homeland Security Presidential Directive 9 tasks the Secretaries of Agriculture and Homeland Security to develop a plan to provide safe, secure, and state-of-the-art agriculture biocontainment laboratories for research and development of diagnostic capabilities and medical countermeasures for foreign animal and zoonotic diseases. To partially meet these obligations, DHS has requested Congress to appropriate funds to construct a new facility, the National Bio- and Agro-Defense Facility (NBAF). This facility would house high-containment laboratories able to handle the pathogens currently under investigation at PIADC, as well as other pathogens of interest. Six candidate sites have been identified, one of which is Plum Island. The DHS plans to select the site in 2008 and open NBAF in 2014.

The U.S. Army Medical Research Institute of Infectious Diseases in Frederick, Maryland, is designed to handle pathogens that cause serious or potentially lethal diseases, which require the research performed on them be contained to specialized laboratories. In 2007 a decision was made to expand those facilities causing concern among area residents that public health and safety risks, and strategies to mitigate those concerns were not adequately considered in the decision to go forward with the expansion. In Evaluation of the Health and Safety Risks of the New USAMRIID High Containment Facilities at Fort Detrick, Maryland a group of experts in areas including biosafety, infectious diseases, industrial hygiene, environmental engineering, risk assessment and epidemiology, explored whether measures were being taken to ensure prevention and mitigation of risk to the health and safety of workers and the public. They also assessed whether the procedures and regulations employed meet accepted standards of the Centers for Disease Control and Prevention and the National Institutes of Health. Evaluation of the Health and Safety Risks of the New USAMRIID High Containment Facilities at Fort Detrick, Maryland evaluates the health and safety aspects of the environmental impact statement developed to support the construction of the new laboratories and explores the institute's operating requirements, medical and emergency management response plans and communication and cooperation with the public. The book recommends that USAMRIID continue to set high standards for advancing security, operational, and biosurety measures, and that additional measures be taken to provide assurance that experienced medical professionals are readily available to consult on unusual infectious diseases. It also suggests that USAMRIID expand its two-way communications with the public.