A new National Research Council report requested by Congress finds "several major shortcomings" in a U.S. Department of Homeland Security assessment of risks associated with operating the proposed National Bio- and Agro-Defense Facility (NBAF) in Manhattan, Kan. 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.
Based on the DHS risk assessment reviewed by the Research Council committee, 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 Research Council report says the risks and costs of a pathogen being accidently released from the facility could be significantly higher than indicated by the assessment. Although the committee that wrote the report recognizes the need for a biocontainment facility to be built in the United States like the one proposed in Kansas, it was not asked to provide judgment about whether the location is appropriate for the proposed facility.
"Building a facility that is capable of large animal work on a scale greater than other high-containment laboratories presents new and unknown risks that could not be accounted for in the DHS risk assessment because of a lack of data and experience," said Ronald Atlas, chair of the committee, a professor of biology and public health, and co-director of the Center for Health Preparedness at the University of Louisville in Kentucky. "The risk assessment should be viewed as a starting point, and given more time, it could have progressed further. As more information emerges, an updated analysis could be appropriate."
Congress requested that DHS produce a site-specific biosafety and biosecurity risk assessment (SSRA) of the proposed NBAF, and it 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. The facility would be the world's third Biosafety-Level 4 Pathogen laboratory that could work with large animals; the other two facilities are in Australia and Canada. It would replace the aging Plum Island Animal Disease Center located nearly 2 miles off Long Island. The United States has not experienced an outbreak of FMD since 1929, and research involving FMD has not been permitted on the U.S. mainland since 1937.
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 accidentally 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.
In addition, the committee found the assessment's estimates for the potential spread of FMD throughout the United States once a leak occurred overly optimistic in projecting how the disease could be controlled and eradicated. Although the SSRA recognizes that Manhattan, Kan., is "a hub of animal movement for the entire United States" and that "in reality, as infected animals are moved throughout the country, pockets of the infection would be expected to occur great distances from the initial focus of infection," its models were limited to seven states and excluded animals -- especially key species susceptible to FMD -- moving to and within other states, Canada, and Mexico. The Research Council report noted that if FMD escapes from the NBAF, it is likely to cause a widespread and economically devastating outbreak. Roughly 9.5 percent of the U.S. cattle inventory lies within a 200-mile radius of the facility. Given that the disease is highly contagious and that the chance of its escape is not zero, rigorous and robust regional and national mitigation strategies that address an extensive outbreak of FMD are needed before the facility opens, the committee urged.
Another concern of the committee was the lack of an early-release detection and response system, clinical isolation facilities, and world-class infectious disease clinicians experienced in diagnosing and treating laboratory staff or communities exposed to dangerous pathogens that affect people. Mercy Regional Health Center, the sole medical center close to the NBAF site, does not have such resources. If a pathogen escapes or a laboratory worker acquires an infection, the deficiency of the location would become immediately apparent, which will not only damage the credibility of the federal agencies involved but also potentially cost human lives, the committee said.
The SSRA and the Research Council report also identify a number of strategies that could lower the risk and potential impact of a release of FMD or other dangerous pathogen from the NBAF. The committee was precluded from conducting its own risk assessment to determine whether implementing such strategies could significantly reduce the risks shown in the document. The SSRA's lack of information on the potential effectiveness of risk reduction and mitigation strategies is a major reason the committee concluded that it is incomplete. For instance, the SSRA observes that an FMD outbreak's risk can be "nearly completely mitigated" by active surveillance but does not discuss what implementation measures this would require.
"We need a facility like the proposed NBAF," Atlas said. "The report makes no judgment on whether the Kansas location is an appropriate site for the proposed facility or on what risk is acceptable to society. Those questions are left to policymakers and future risk assessments."
The report was sponsored by the U.S. Department of Homeland Security. The National Academy of Sciences, National Academy of Engineering, Institute of Medicine, and National Research Council make up the National Academies.
Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas.
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