National Strategy for Oversight Is Needed
GAO-09-1045T, Sep 22, 2009
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This testimony discusses our report on a national strategy for high-containment laboratories that deal with dangerous--pathogens also known as biosafety level-3 (BSL-3) laboratories and biosafety level-4 (BSL-4) laboratories--in the United States, which was released yesterday. The number of high-containment laboratories that work with dangerous biological pathogens have proliferated in recent years. In 2007, we reported on several issues associated with the proliferation of high-containment laboratories in the United States, including risks posed by biosafety incidents that have occurred in the past. The Federal Bureau of Investigation's allegation in August 2008 that a scientist at the U.S. Army Medical Research Institute of Infectious Diseases was the sole perpetrator of the 2001 anthrax attacks raised additional concerns about the possibility of insider misuse of high-containment laboratory facilities, material, and technology. The public is concerned about these laboratories because the deliberate or accidental release of biological agents can have disastrous consequences by exposing workers and the public to dangerous pathogens. Highly publicized laboratory errors and controversies about where high-containment laboratories should be located have raised questions about whether the governing framework, oversight, and standards for biosafety and biosecurity measures are adequate. In this context, Congress asked us to address the following questions: 1. To what extent, and in what areas, has the number of high-containment laboratories increased in the United States? 2. Which federal agency is responsible for tracking the expansion of high-containment laboratories and determining the associated aggregate risks? 3. What lessons can be learned from highly publicized incidents at high-containment laboratories and actions taken by the regulatory agencies?
The recent expansion of high-containment laboratories in the United States began in response to the need to develop medical countermeasures and better risk evaluations after the anthrax attacks in 2001. Understandably, the expansion initially lacked a clear, governmentwide coordinated strategy. In that emergency situation, the expansion was based on individual agency perceptions of requirements relative to the capacity their high-containment labs required as well as the availability of congressionally appropriated funding. While there is a consensus among federal agency officials and experts that some degree of risk is always associated with high-containment laboratories, no one agency is responsible for determining, or able to determine, the aggregate or cumulative risks associated with the expansion of these high-containment laboratories. As a consequence, no federal agency can determine whether high-containment laboratory capacity may now meet or exceed the national need or is at a level that can be operated safely. Four highly publicized incidents in high-containment laboratories, as well as evidence in the scientific literature, demonstrate that while laboratory accidents are rare, they do occur, primarily due to human error or systems (management and technical operations) failure, including the failure of safety equipment and procedures. If an agency were tasked or a mechanism were established with the purpose of overseeing the expansion of high-containment laboratories, it could develop a strategic plan to (1) ensure that the number and capabilities of potentially dangerous high-containment laboratories are no greater or less than necessary, (2) balance the risks and benefits of expanding such laboratories, and (3) determine the type of oversight needed.