Biological Research Laboratories: Issues Associated with the Expansion of Laboratories Funded by the National Institute of Allergy and Infectious Diseases

The fall 2001 anthrax attacks revealed gaps in the nation's preparedness for public health emergencies resulting from bioterrorism. Among the tools needed for responding to such emergencies are vaccines to prevent the spread of disease; tests for rapid diagnosis; and therapeutics, including drugs, for treatment. Because the pathogens that could be used in bioterrorist attacks carry the risk of significant morbidity or are potentially lethal, biological research aimed at providing the tools needed to combat these agents is required to be conducted in facilities known as biocontainment laboratories. These facilities are to be designed, constructed, and operated in a manner to prevent accidental release of infectious or hazardous agents within the laboratory and to protect laboratory workers and the environment external to the laboratory, including the community, from exposure to these research materials. The National Institute of Allergy and Infectious Diseases (NIAID) is the primary institute at the Department of Health and Human Services' (HHS) National Institutes of Health (NIH) that is responsible for research on pathogens that could be used in a bioterrorist attack and for research on emerging infectious disease pathogens. The Centers for Disease Control and Prevention (CDC) is also responsible for research on such pathogens. Following the anthrax attacks, NIAID expanded its research program to emphasize biodefense research. In February 2002, it issued the NIAID Strategic Plan for Biodefense Research, which outlined a need for research aimed at the development of vaccines, diagnostics, and therapeutics and construction of additional biocontainment laboratories in which to conduct the research. According to NIH, a shortage of high-level biocontainment laboratories exists. In response to the Strategic Plan, NIAID established the National Biocontainment Laboratory (NBL) and Regional Biocontainment Laboratory (RBL) construction programs. The overall objective of the NBL construction program is to provide funding to design and construct state-of-the-art biosafety level (BSL) 4, 3, and 2 laboratories, including associated research and administrative support space, and the objective of the RBL construction program is to provide similar facilities containing BSL-3 and -2 laboratories. As of January 2007, the NBLs and RBLs are at various stages of design and construction and are not yet operational. Because the deliberate or accidental release of biological pathogens from a biocontainment laboratory could have disastrous consequences, concerns exist about the oversight of these laboratories. This report responds to Congress's November 30, 2005, request that we provide information associated with the construction of NBLs and RBLs funded by NIAID in fiscal years 2003 and 2005. Congress's questions covered requirements and guidance for these laboratories, funding award factors, communication with the public, and research agendas. Enclosure I provides background information for these questions and our answers to the questions, enclosure II provides lists of infectious agents with the potential to be used in bioterrorism, and enclosure III provides examples of regulations and guidelines applicable to NBL and RBL operations and security procedures.