	No Federal Entity Is Responsible for Expansion and Oversight of High- Containment Laboratories

The number of biosafety level (BSL)-3 and BSL-4 laboratories (high- containment laboratories) began to rise in the late 1990s, accelerating  after the anthrax attacks throughout the United States. Our work has found that expansion of high-containment laboratories was  not based on a government-wide coordinated strategy. The expansion  was based on the perceptions of individual agencies about the capacity  required for their individual missions and the high-containment laboratory  activities needed to meet those missions, as well as the availability of  congressionally approved funding. We have not found any national research agenda linking all  these agencies, even at the federal level, that would allow for a national  needs assessment, strategic plan, or coordinated oversight. As we last  reported in 2013, after more than 12 years, we have not been able to find  any detailed projections based on a government-wide strategic evaluation  of research requirements based on public health or national security  needs. Without this information, there is little assurance of having facilities  with the right capacity to meet our national needs. National Standards for Designing, Constructing, Commissioning, Operating, and Maintaining High- Containment Laboratories Are Needed

Our work on this issue has found a continued lack of national standards  for designing, constructing, commissioning, and operating high- containment laboratories. For example, we noted in our 2009 report that the  absence of national standards means that the laboratories may vary from  place to place because of differences in local building requirements or  standards for safe operations. This incident highlighted the risk of relying on local building codes to  ensure the safety of high-containment laboratories in the absence of  national standards or testing procedures specific to those laboratories. Some guidance exists about designing, constructing, and operating high- containment laboratories. The Biosafety in Microbiological and Biomedical  Laboratories guidance, often referred to as BMBL recommends various  design, construction and operations standards, but our work has found it  is not universally followed. of whether the suggested design, construction, and operations standards  are achieved. As we have recommended, national standards would be  valuable for not only new laboratory construction but also periodic  upgrades. Many  experts agree that as the number of high-containment laboratories has  increased, so the overall risk of an accidental or deliberate release of a  dangerous pathogen will also increase. The June 2014 Incident at the CDC Laboratories and GAO’s Preliminary Observation

The June 2014 incident in which live anthrax bacteria were transferred  from a BSL-3 contained environment to lower-level (BSL-2) containment  laboratories at CDC in Atlanta resulted in the potential exposure of tens of  workers to the highly virulent Ames strain of anthrax. CDC’s July 11, 2014, Report on the Potential Exposure to Anthrax  describes a number of actions that CDC plans to take within its  responsibilities to avoid another incident like the one in June. However,  we continue to believe that a national strategy is warranted that would  evaluate the requirements for high-containment laboratories, set and  maintain national standards for such laboratories’ construction and  operation, and maintain a national strategy for the oversight of  laboratories that conduct important research on highly infectious  pathogens. Related GAO Products

High-Containment Laboratories: Assessment of the Nation’s Need Is  Missing. High-Containment Biosafety Laboratories: Preliminary Observations on  the Oversight of the Proliferation of BSL-3 and BSL-4 Laboratories in the  United States. Biological Research Laboratories: Issues Associated with the Expansion  of Laboratories Funded by the National Institute of Allergy and Infectious  Diseases.
Why GAO Did This Study

Recent biosecurity incidents—such as the June 5, 2014, potential exposure of staff in Atlanta laboratories at the Centers for Disease Control and Prevention (CDC) to live spores of a strain of anthrax—highlight the importance of maintaining biosafety and biosecurity protocols at high-containment laboratories. This statement summarizes the results of GAO's past work on the oversight of high-containment laboratories, those designed for handling dangerous pathogens and emerging infectious diseases. Specifically, this statement addresses (1) the need for governmentwide strategic planning for the requirements for high-containment laboratories, including assessment of their risks; (2) the need for national standards for designing, constructing, commissioning, operating, and maintaining such laboratories; and (3) the oversight of biosafety and biosecurity at high-containment laboratories. In addition, it provides GAO's preliminary observations on the potential exposure of CDC staff to anthrax. For this preliminary work, GAO reviewed agency documents, including a report on the potential exposure, and scientific literature; and interviewed CDC officials.

What GAO Found

No federal entity is responsible for strategic planning and oversight of high-containment laboratories. Since the 1990s, the number of high-containment laboratories has risen; however, the expansion of high-containment laboratories was not based on a government-wide coordinated strategy. Instead, the expansion was based on the perceptions of individual agencies about the capacity required for their individual missions and the high-containment laboratory activities needed to meet those missions, as well as the availability of congressionally approved funding. Consequent to this mode of expansion, there was no research agenda linking all these agencies, even at the federal level, that would allow for a national needs assessment, strategic plan, or coordinated oversight. As GAO last reported in 2013, after more than 12 years, GAO has not been able to find any detailed projections based on a government-wide strategic evaluation of research requirements based on public health or national security needs. Without this information, there is little assurance of having facilities with the right capacity to meet the nation's needs.
GAO's past work has found a continued lack of national standards for designing, constructing, commissioning, and operating high-containment laboratories. As noted in a 2009 report, the absence of national standards means that the laboratories may vary from place to place because of differences in local building requirements or standards for safe operations. Some guidance exists about designing, constructing, and operating high-containment laboratories. Specifically, the Biosafety in Microbiological and Biomedical Laboratories guidance recommends various design, construction, and operations standards, but GAO's work has found it is not universally followed. The guidance also does not recommend an assessment of whether the suggested design, construction, and operational standards are achieved. As GAO has reported, national standards are valuable not only in relation to new laboratory construction but also in ensuring compliance for periodic upgrades.
No one agency is responsible for determining the aggregate or cumulative risks associated with the continued expansion of high-containment laboratories; according to experts and federal officials GAO interviewed for prior work, the oversight of these laboratories is fragmented and largely self-policing.
On July 11, 2014, the Centers for Disease Control and Prevention (CDC) released a report on the potential exposure to anthrax that described a number of actions that CDC plans to take within its responsibilities to avoid another incident like the one in June. The incident in June was caused when a laboratory scientist inadvertently failed to sterilize plates containing samples of anthrax, derived with a new method, and transferred them to a facility with lower biosecurity protocols. This incident and the inherent risks of biosecurity highlight the need for a national strategy to evaluate the requirements for high-containment laboratories, set and maintain national standards for such laboratories' construction and operation, and maintain a national strategy for the oversight of laboratories that conduct important work on highly infectious pathogens.

What GAO Recommends

This testimony contains no new recommendations, but GAO has made recommendations in prior reports to responsible agencies.