High-Containment Laboratories:

Assessment of the Nation's Need Is Missing

GAO-13-466R: Published: Feb 25, 2013. Publicly Released: Mar 25, 2013.

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What GAO Found

There is still no one agency or group that knows the nation's need for all U.S. high- containment laboratories, including the research priorities and the capacity, number and location, to address priorities. This deficiency may be more critical today than 3 years ago because current budget constraints make prioritization essential. Since the publication of our report in 2009, the number of high-containment laboratories has increased. Although modern high-containment technologies (for example, high-efficiency particulate air [HEPA] filtration) in conjunction with laboratory design have been effective in reducing the level of risk, there is nevertheless some degree of risk associated with design, construction, operations, and maintenance of high-containment laboratories. This was realized following a Centers for Disease Control and Prevention (CDC) power failure incident in Atlanta, Georgia, where no biological agent was released but that showed the difficulties in maintaining biological containment, and a leaky pipe incident in Pirbright, United Kingdom, that failed to maintain biological containment. Increasing the number of laboratories also increases the aggregate national risk.

GAO found a continued lack of national standards for the design, construction, commissioning, and operation of high-containment laboratories. These laboratories are expensive to build, operate, and maintain. As we noted in our 2009 report, in the absence of national standards, it is likely that there may be variations resulting from local requirements, but without an underpinning set of standards to ensure safe operations. In the absence of some fundamental criteria, each laboratory can be designed, constructed, and maintained according to local requirements. This will make it difficult to be able to assess and guarantee safety, as we noted in our 2009 report. For example, while investigating a power outage incident in its recently constructed BSL-4 laboratory, the CDC later determined that, some time earlier, a critical grounding cable buried in the ground outside the building had been cut by construction workers digging at an adjacent site. The cutting of the grounding cable, which had hitherto gone unnoticed by CDC facility managers, compromised the electrical system of the facility that housed the BSL-4 laboratory. Given that grounding cables were cut, it is apparent that the building's integrity as it related to adjacent construction was not adequately supervised. CDC officials stated in 2009 that standard procedures under local building codes did not require monitoring of the integrity of the new BSL-4 facility's electrical grounding. This incident highlighted the risks inherent in relying on local building codes to ensure the safety of high-containment laboratories, as there are no building codes and testing procedures specifically for those laboratories.

Why GAO Did This Study

High-containment laboratories, biosafety level (BSL)-3 and BSL-4 laboratories, are used to (1) develop medical and veterinary countermeasures against biological agents and (2) research the risks these agents pose to human health, animal health, the food supply, and the U.S. economy. In 2009 GAO reported on the expansion of these laboratories, which began in the 1990s and accelerated after the 2001 anthrax attack. GAO found that although this expansion was occurring, no single federal agency was responsible for assessing overall laboratory needs. Instead, departments and agencies only assessed laboratory needs that were within the scope of their respective missions. GAO therefore determined that a national strategy for oversight, including periodic assessments of the nation's need for these laboratories, was called for. GAO also found that the absence of national standards for laboratory design, construction, commissioning, operations, and maintenance raised concerns and increased the risk of laboratory accidents.

GAO's 2009 report made two recommendations to the National Security Advisor, located in the Executive Office of the President (EOP), to address these weaknesses. Specifically, GAO recommended that the National Security Advisor identify a single entity, charged with periodic government-wide strategic evaluation of high-containment laboratories, that will (1) determine (a) the number, location, and mission of the laboratories needed to effectively meet national goals to counter biothreats; (b) the existing capacity within the United States; (c) the aggregate risks associated with the laboratories' expansion; and (d) the type of oversight needed and (2) develop, in consultation with the scientific community, national standards for the design, construction, commissioning, and operation of high-containment laboratories, specifically including provisions for long-term maintenance. This report addresses the following questions:

1. What actions have been taken to implement the recommendations made in our 2009 report?

2. To what extent is action still needed concerning (1) an assessment of the nation's need for high-containment laboratories, including their numbers, functions, and research priorities and (2) the development of any national standards for designing, constructing, commissioning, maintaining, and operating high-containment laboratories?

What GAO Recommends

GAO recommends that the Office of Science and Technology Policy (OSTP) ensure that periodic assessments of national biodefense research and development needs are conducted. These assessments would include whether appropriate resources, in particular, high containment laboratories, exist to meet those needs. GAO also recommends that the OSTP examine the need to establish national standards relating to designing, constructing, commissioning, maintaining, and operating high-containment laboratories.

For more information, contact Nancy Kingsbury at (202) 512-2700 or kingsburyn@gao.gov.

Recommendations for Executive Action

  1. Status: Closed - Implemented

    Comments: In May 2013, OSTP reported to GAO that it had conducted periodic assessments of national biodefense research and development needs which, in many cases, included discussion of whether appropriate resources, including high containment laboratories, exist to meet those needs. Some periodic assessments of the Nation's biodefense research and development needs had been conducted through the National Science and Technology Council (NSTC), Committee on Homeland and National Security's Subcommittee on Biological Defense Research and Development, which was chartered in July 2011 to coordinate and collaborate on defensive research, development, testing, and evaluation addressing biological threats to national security. Such assessments include "The National Biosurveillance Science and Technology Roadmap" and "The National Biological Response and Recovery Science and Technology Roadmap" that are recently publically available on the NSTC website. These efforts implement GAO's report recommendation.

    Recommendation: The OSTP should ensure that periodic assessments of national biodefense research and development needs are conducted. These assessments would include whether appropriate resources, in particular, high containment laboratories, exist to meet those needs.

    Agency Affected: Executive Office of the President: Office of Science and Technology Policy

  2. Status: Closed - Implemented

    Comments: In May 2013, OSTP reported that it has been examining the need for national standards relating to designing, constructing, commissioning, maintaining, and operating high-containment laboratories through its "Interagency Biorisk Management Working Group" chartered in May 2012. It is chartered, an OSTP official said, to coordinate and collaborate on mechanisms for strengthening research laboratory biorisk management that includes biosafety, biocontainment and biosecurity. OSTP officials also stated that it follows existing statutes and guidance (OMB and EOP) on government agencies participating in private-sector-led voluntary consensus standards development processes.

    Recommendation: The OSTP should examine the need to establish national standards relating to designing, constructing, commissioning, maintaining, and operating high-containment laboratories.

    Agency Affected: Executive Office of the President: Office of Science and Technology Policy

 

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