National Bio and Agro-Defense Facility

The National Bio and Agro-Defense Facility (NBAF) is a planned United States government-run research facility that will replace the 1950s-era Plum Island Animal Disease Center in New York, which is "nearing the end of its lifecycle and is too small to meet the nation’s research needs."^[1] The NBAF will be operated under the authority of the United States Department of Homeland Security, with the U.S. Department of Agriculture’s Agriculture Research Service (USDA-ARS) and Animal Plant Health Inspection Service, Veterinary Services (USDA-APHIS-VS) as primary research partners.^[1][2]

The facility, which is not yet built, will be located in Manhattan, Kansas.^[1] Construction work began at the location of the 520,000-square-foot (48,000 m²) facility in 2010. It is scheduled to become operational by 2015, and to employ up to 300 people.

The Government Accountability Office questioned the choice of location in a July 2010 draft report for being on the mainland U.S., unlike the current Plum Island facility.^[3]

Purpose

The NBAF was initially proposed because the current facility on Plum Island was considered inadequate by the Department of Homeland Security, as the facility is too small and does not have Biosafety Level 4 (BSL-4) capabilities.^[4]

The new facility will research and develop countermeasures to combat "high-consequence biological threats involving human, zoonotic (i.e., transmitted from animals to humans), and foreign animal diseases."^[1] Included among the diseases to be studied at the research lab are: Foot-and-mouth disease, classical swine fever, African swine fever and contagious bovine pleuropneumonia. The facility will include Biosafety Level 3 (BSL-3) and Biosafety Level 4 laboratories.^[4]

Location

The proposed location on the KSU campus is close to the Biosecurity Research Institute (BRI)

The Department of Homeland Security decided to locate the NBAF in Manhattan, Kansas, after a multi-year process. Out of 29 original sites considered in 2006, the agency selected six finalists in 2008:

• Kansas State University – Manhattan, Kansas
• Plum Island
• Flora Industrial Park – Madison County, Mississippi
• Texas Research Park – San Antonio, Texas
• Umstead Research Farm – Granville County, North Carolina
• University of Georgia/South Milledge Ave. – Athens, Georgia

By memo dated December 4, 2008, the Department of Homeland Security named the Kansas site as the preferred location for the NBAF.^[5] On January 16, 2009, the record of decision was published in the Federal Register.^[4]

Discussion

Plum Island is the only research facility currently studying foot and mouth disease in the U.S. However, the NBAF will be located on the mainland, prompting concern from the GAO and a handful of Congressional Democrats.^[3][6] In 2008, the Government Accountability Office (GAO) was asked to evaluate the evidence DHS used to support its decision that FMD work can be done safely on the U.S. mainland, whether an island location provides any additional protection over and above that provided by modern high containment laboratories on the mainland, and the economic consequences of an FMD outbreak on the U.S. mainland. In preparing this testimony, GAO interviewed officials from DHS and USDA, talked with experts in FMD and high-containment laboratories worldwide, and reviewed studies on FMD, high-containment laboratories, and the economic consequences of FMD outbreaks. GAO also visited the Plum Island Animal Disease Center and other animal biocontainment laboratories in other countries. This testimony "HIGH-CONTAINMENT BIOSAFETY LABORATORIES: DHS Lacks Evidence to Conclude That Foot-and-Mouth Disease Research Can Be Done Safely on the U.S. Mainland" is listed as GAO-08-821T.

In February 2009, Department of Homeland Security Secretary Janet Napolitano visited the NBAF site and expressed commitment to the project. Napolitano said, "In reality, this is the best place in the United States to have this type of facility because of the expertise in the animal health community that already exists here."^[5]

Several rural advocacy groups, such as the National Grange, have spoken out against the idea of locating the facility on the mainland.^[7] In addition, groups formed in Manhattan; Athens, Georgia; and Butner, North Carolina to oppose the laboratory's proposed location in those cities.^[5][6][8]

At the same time, support for the NBAF has been expressed by a range of scientific experts and agriculture groups, including the American Farm Bureau, the National Cattlemen’s Beef Association, deans of numerous veterinary medicine colleges, and others who see NBAF research as critical to protecting the American food supply and agriculture economy.^[9] Dr. W. Ron DeHaven, CEO and executive vice president of the American Veterinary Medical Association, has written that the NBAF could become the nation’s Centers for Disease Control and Prevention for animal health.^[10]

DeHaven and others have noted the work of the bipartisan Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism, which has highlighted the threat of biological attacks against the U.S. and the need to increase federal government efforts to prevent and increase preparedness for such threats.^[11]

Because of the concerns raised by the Government Accountability Office (GAO) Congress instructed DHS to complete a "site-specific biosafety and biosecurity risk assessment (SSRA)". They also directed the National Academy of Sciences to appoint a committee of the National Research Council (NRC) to conduct an independent evaluation of this SSRA to determine its adequacy and validity. Congress would not release construction funds until these were completed and evaluated. "Evaluation of a Site‐Specific Risk Assessment for the Department of Homeland Security's Planned National Bio‐ and Agro‐Defense Facility in Manhattan, Kansas" was released on Nov. 15, 2010.

This evaluation came up with 11 major findings:

"FINDINGS The SSRA shows that constructing the NBAF in Manhattan, Kansas, carries a number of risks and that the impact of an FMDv release could potentially have significant economic, health, and national security impacts. Some risks and impacts are generic to any high-containment large-animal facility, whereas others are specific to the Manhattan, Kansas, site. The risk of release is primarily a generic concern, whereas the risk of infection, spread, and impact is largely related to the site. The SSRA’s estimates indicate that the probability of an infection resulting from a laboratory release of FMDv from the NBAF in Manhattan, Kansas approaches 70% over 50 years (see Figure 3-1) with an economic impact of $9-50 billion. The committee finds that the risks and costs could well be significantly higher than that, and elaborates on those findings below.

Finding 1: The SSRA lacks evidence to support the conclusion that the risk of release that results in infection is very low relative to the risk of infection introduced from an external source. The SSRA states that “given the combination of proven biocontainment design and robust operation procedures and response planning, the NBAF operations in Manhattan, Kansas overall brings extremely low risk relative to the greater risk of the intentional or accidental introduction of FMDv by an external source” (page 1, SSRA follow-up letter, July 28, 2010). Although the committee affirms that engineering and operational safeguards can substantially lower the risk of release, the committee does not concur with the implied conclusion of the SSRA that there is a very low risk of release that would result in an infection. That comparison “to the risk of intentional or accidental introduction” is misleading because the SSRA does not consider or quantify the risk of infection from an external source; thus, with no data for comparison, the SSRA’s conclusion of “extremely low risk” is invalid.

Finding 2: The SSRA overlooks some critical issues, both site-specific and non-site-specific, that could significantly elevate the risk of accidental release and spread of pathogens.

Finding 3: The SSRA has several methodological flaws related to dispersion modeling, tornado assessment, and epidemiological modeling.

Finding 4: The committee agrees with the SSRA’s conclusion that for FMDv, long-distance plume transport will likely be less important than the near-site exposure of cattle.

Finding 5: Substantial gaps in knowledge make predicting the course of an FMD outbreak very difficult, which led to weaknesses in the SSRA.'

Finding 6: Although the economic modeling was conducted with appropriate methods, the epidemiological estimates used as inputs to the SSRA were flawed.

Finding 7: The committee agrees with the SSRA’s conclusion that early detection and rapid response can limit the impact of an FMDv release from the NBAF, but is concerned that the SSRA does not describe how the NBAF could rapidly detect such a release.

Finding 8: The SSRA lacks a comprehensive mitigation strategy developed with stakeholder input for addressing major issues related to a pathogen release.

Finding 9: The committee agrees with the SSRA’s conclusion that human error will be the most likely cause of an accidental pathogen release, and fomite carriage is the most likely way that a pathogen would escape the facility’s outer biocontainment and biosecurity envelope.

Finding 10: The committee agrees with the SSRA’s conclusion that investment in biosafety and biosecurity engineering and the training of personnel and responders can reduce the risks, but is concerned about current design plans that potentially compromise safety measures. The committee is seriously concerned about the SSRA’s current designs which omit redundant HEPA filters—but are strongly recommended by the BMBL—for reasons of practicality and cost-savings. Any facility design compromises due to budgetary limitations will need to be viewed as inconsistent with the mission of providing a state-of-the-art facility with minimal risk of pathogen escape from containment.

Finding 11: The SSRA’s qualitative risk assessment of work with BSL-4 pathogens in large animals was inadequate. "The committee does not agree that the BSL-3 quantitative risk assessment adequately frames the risks associated with operating a BSL-4 large animal facility, because it is insufficient to use BSL-3 pathogens to predict risks associated with BSL-4 pathogens that are zoonotic and for which no treatment is available. Given that the qualitative risk assessment was inadequate and that the SSRA did not perform a quantitative risk assessment for BSL-4 agents, further evaluation of risks and mitigation strategies will need to be established for BSL-4 agents (for example, Nipah and Hendra viruses or other emerging BSL-4 zoonotic pathogens) to identify ways of minimizing the risks associated with working with those agents in a large animal facility setting."^{[attribution needed]}

References

1. ^ ^{a b c d} "National Bio and Agro-Defense Facility" (English). U.S. Department of Homeland Security. http://www.dhs.gov/xres/labs/editorial_0762.shtm. Retrieved 2010-07-21. 
2. ^ "Facility Research & Staffing" (English). U.S. Department of Homeland Security. http://www.dhs.gov/files/labs/gc_1181073261627.shtm. Retrieved 2010-07-21. 
3. ^ ^{a b} Leonnig, Carol D. (2009-07-27). "Infectious diseases study site questioned: Tornado Alley may not be safe, GAO says". Washington Post. http://www.washingtonpost.com/wp-dyn/content/article/2009/07/26/AR2009072602857.html. Retrieved 2010-07-21. 
4. ^ ^{a b c} (English) Federal Register: ROD for NBAF, U.S. Department of Homeland Security, January 16, 2009, http://edocket.access.gpo.gov/2009/E9-914.htm, retrieved 2010-07-21 
5. ^ ^{a b c} "DHS Secretary, Governor Tour BRI Facility". Kansas State University Collegian. February 11, 2009. http://www.kstatecollegian.com/dhs-secretary-governor-tour-bri-facility-1.1371354. Retrieved 2010-07-21. 
6. ^ ^{a b} "Dangerous Animal Virus on US Mainland?". The Associated Press. 2008-04-11. http://www.newsvine.com/_news/2008/04/11/1423998-dangerous-animal-virus-on-us-mainland. Retrieved 2010-07-21. 
7. ^ National Grange Opposes Mainland Research Facility
8. ^ No NBAF in Kansas
9. ^ NBAF in Kansas
10. ^ K-State Bio Lab Could be the CDC for Animal Health
11. ^ Commission on the Prevention of WMD: Report Card

External links

• Official DHS site