Biological Research:

Observations on DHS's Analyses Concerning Whether FMD Research Can Be Done as Safely on the Mainland as on Plum Island

GAO-09-747: Published: Jul 30, 2009. Publicly Released: Jul 30, 2009.

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Foot-and-mouth disease (FMD) is the most highly infectious animal disease known: nearly 100 percent of exposed animals become infected with it. Although the United States has not had an outbreak of FMD since 1929, a single outbreak of FMD virus as a result of an accidental or intentional release from a laboratory on the U.S. mainland could have significant consequences for U.S. agriculture. The traditional approach to the disease, once infection is confirmed, is to depopulate infected and potentially infected livestock herds to eradicate the disease. The value of U.S. livestock sales was $140 billion in 2007; about 10 percent of this figure, or approximately $13 billion, was accounted for by export markets. The Plum Island Animal Disease Center (PIADC), on a federally owned island off the northern tip of Long Island, New York, is the only facility in the United States that studies the live FMD virus. The U.S. Department of Agriculture (USDA) was responsible for the PIADC from its opening in the 1950s until June 2003, when USDA transferred responsibility for it to the U.S. Department of Homeland Security (DHS), as required by the Homeland Security Act of 2002. The act specified that USDA would continue to have access to Plum Island to conduct diagnostic and research work on foreign animal diseases, and it authorized the president to transfer funds from USDA to DHS to operate the PIADC. Also, under Homeland Security Presidential Directive 9 (HSPD-9), the secretary of Agriculture and the secretary of Homeland Security are to develop a plan to provide safe, secure, and state-of-the-art agricultural biocontainment laboratories for researching and developing diagnostic capabilities for foreign animal and zoonotic diseases. On January 19, 2006, DHS announced that to meet its obligations under HSPD-9, it would construct and operate a new facility--the National Bio- and Agro-Defense Facility (NBAF)--containing several biosafety level 3 (BSL-3) laboratories, BSL-3 agricultural (BSL-3-Ag) laboratories, and biosafety level 4 (BSL-4) laboratories. FMD research is to be performed in a BSL-3-Ag laboratory. When fully operational, the NBAF is meant to replace the PIADC. The primary research and diagnostic focus at the PIADC is foreign or exotic diseases, including FMD virus, that could affect livestock, including cattle, pigs, and sheep. DHS stated that the PIADC was "nearing the end of its life cycle" and was lacking critical capabilities to continue as the primary facility for such work. Another reason DHS cited was the need to be close to research facilities. According to DHS, although the PIADC coordinates with many academic institutes throughout the northeast, its isolated island location means that few academic institutes are within a reasonable commuting distance; DHS believes that these are needed to provide research support and collaboration required for the anticipated NBAF program. We are doing this work to respond to the statutory mandate in the fiscal year 2009 appropriations act for DHS (Consolidated Security, Disaster Assistance, and Continuing Appropriations Act, 2009 (Public Law 110-329)). The act restricted DHS's obligation of funds for constructing the NBAF on the mainland until DHS completed a risk assessment on whether FMD work can be done safely on the U.S. mainland and we reviewed DHS's risk assessment. In our review, we specifically assessed the evidence DHS used to conclude that work with FMD can be conducted as safely on the U.S. mainland as on Plum Island, New York.

DHS developed a threat and risk analysis independent of the environmental impact statement (EIS) that identified and evaluated potential security risks--threats, vulnerabilities, and consequences--that might be encountered in operating the NBAF. They included crimes against people and property and threats from compromised or disgruntled employees. The objectives of this analysis were to present the risks and effective mitigation strategies for ensuring the NBAF's secure operation and to help DHS select the site with the fewest unique security threats. DHS concluded that the EIS and threat and risk analysis showed very little differentiation across the six sites and considered that the safety and security risks that had been identified at all sites were acceptable, with or without mitigation. Specifically, for all sites the risk was zero to low for all accident scenarios, except for an overpressure fire--an explosion from the buildup of a large amount of gas or flammable chemical in an enclosed area. The risk of an overpressure fire accident was moderate for all sites For all sites--except Plum Island--the overall risk rank was moderate, based on the potential for infection and opportunity for disease to spread through livestock or wildlife. The Plum Island site's overall risk rank was low, because the likelihood of any disease spreading beyond the island was small, since animals do not live in the vicinity and the potential for infection is less. The threat and risk assessment concluded that the insider threat would be the biggest threat to the NBAF and would be independent of the site.

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