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both human and animal health. In overseeing the Select Agent Program, CDC’s Division of Select Agents and Toxins and APHIS’s Agriculture Select Agent Services are responsible for ensuring that high-containment laboratories that work with select agents comply with requirements of the select agent regulations.18 They do this by inspecting laboratories that are registered with the Select Agent Program, ensuring that individuals who work with these agents undergo a security risk assessment, and investigating and enforcing any incidents in which noncompliance with the regulations may have occurred, among other responsibilities. As of May 31, 2016, a total of 286 16Pub. L. No. 107-188, title II, 116 Stat. 594 (June 12, 2002). For more information on the background of the Select Agent Program and regulations, see GAO-09-574. 17In September and October 2001, letters laced with Bacillus anthracis were mailed through the U.S. postal system to two U.S. senators and members of the media. In 2008, the Federal Bureau of Investigation (FBI) alleged that a scientist at the U.S. Army Medical Research Institute of Infectious Diseases was the sole perpetrator of the 2001 attacks. 1842 C.F.R. Part 73 (CDC); 7 C.F.R. Part 331 (APHIS-plant); 9 C.F.R. Part 121 (APHISanimal). Regulation of Pathogens in High-Containment Laboratories Page 12 GAO-16-642 Inactivation of Pathogens entities were registered with the Select Agent Program.19 The Select Agent Program maintains a list of select agents and toxins that they are required to review and republish at least biennially.20 NIH publishes guidelines detailing safety practices for research involving recombinant pathogens.21 Compliance with the NIH guidelines is a condition of accepting funding awards from NIH for research involving recombinant material. As part of these guidelines, laboratories receiving funding must report any incidents involving recombinant pathogens to NIH. NIH has issued an incident reporting template that may be used to report these incidents. 22 The Biosafety in Microbiological and Biomedical Laboratories (BMBL) manual,23 although not prescriptive, is a widely-accepted source of 19An entity is defined in the select agent regulations as any government agency (federal, state, or local), academic institution, corporation, company, partnership, society, association, firm, sole proprietorship, or other legal entity. Each registered entity may house one or more high-containment laboratories. The total number of high-containment laboratories in the United States is unknown, as we found in 2009. GAO-09-574. 20In determining whether to include an agent on the HHS select agent list, the HHS Secretary must consider the following criteria: (1) the effect on human health of exposure to the agent or toxin; (2) the degree of contagiousness of the agent or toxin and the methods by which the agent or toxin is transferred to humans; (3) the availability and effectiveness of pharmacotherapies and immunizations to treat and prevent any illness resulting from infection by the agent or toxin; and (4) any other criteria, including the needs of children and other vulnerable populations, that the Secretary considers appropriate. In determining whether to include an agent or toxin on the USDA list, the USDA Secretary must consider the following criteria: (1) the effect of exposure to the agent or toxin on animal and plant health, and on the production and marketability of animal and plant products; (2) the pathogenicity of the agent or toxin and the methods by which the agent or toxin is transferred to animals or plants; (3) the availability and effectiveness of pharmacotherapies and prophylaxis to treat and prevent any illness caused by the agent or toxin; and (4) any other criteria that the Secretary considers appropriate to protect animal or plant health, or animal or plant products. 21Department of Health and Human Services, National Institutes of Health, NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. 22According to the guidelines, any significant problems, violations of the NIH guidelines, or any significant research-related accidents and illnesses are to be reported to NIH within 30 days. 23Department of Health and Human Services, Centers for Disease Control and Prevention and National Institutes of Health, Biosafety in Microbiological and Biomedical Laboratories, 5th ed. (Washington, D.C.: December 2009). Guidance on the Management of Pathogens in HighContainment Laboratories Page 13 GAO-16-642 Inactivation of Pathogens guidance for all research involving pathogens, regardless of whether they are select agents or recombinant pathogens. The manual outlines the principles and practices of biological safety and security and is published in partnership by CDC and NIH. It applies to all biological safety levels of microbiological laboratories, including high-containment laboratories. According to the BMBL manual, biological safety practices are intended to reduce or eliminate exposure of individuals and the environment to potentially dangerous pathogens, and biological security practices are intended to prevent the loss, theft, or misuse of dangerous pathogens and research-related information by limiting access to facilities, research materials, and information. The total number of incidents involving incomplete inactivation that occurred from 2003 through 2015 is
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