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agent regulations, which program officials told us will include a definition of inactivation; however, the program has received a number of comments from the public in response to these proposed changes and officials told us that further alterations will be made to the proposed rule before it is finalized and submitted.35 Officials from NIH, responsible for the oversight of recombinant pathogens, noted they released an update to the NIH guidelines in April 2016 and currently do not have any other planned updates.36 NIH and CDC are in the process of updating the BMBL manual and officials involved noted they did not yet know the extent to which inactivation would be covered in the next edition of the manual, but that they would consider any comments on how to improve the BMBL as they move forward in the drafting process.37 It is unclear to what extent the planned changes to the select agent regulations and the BMBL manual will provide a clear and consistent definition of inactivation. Officials from NIH responsible for recombinant pathogens and officials in charge of the BMBL manual noted that they 34Based on our previous reporting, we have found that metrics should be reportable in a consistent fashion, and that a key part of consistent reporting is ensuring that standardized definitions, methodologies, and procedures will be used. In addition, we have reported that inconsistent definitions limit the comparability of programs across agencies. See GAO, Defense Inventory: Actions Underway to Implement Improvement Plan, but Steps Needed to Enhance Efforts, GAO-12-493 (Washington, D.C.: May 3, 2012). 35Centers for Disease Control and Prevention, Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review of the List of Select Agents and Toxins and Enhanced Biosafety Requirements, Notice of Proposed Rule Making, 81 Fed. Reg. 2805 (Jan. 19, 2016); Animal and Plant Health Inspection Service, Agricultural Bioterrorism Protection Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List; Amendments to the Select Agent and Toxin Regulations, Proposed Rule, 81 Fed. Reg. 2762 (Jan. 19, 2016). According to USDA and HHS officials, the final rule is scheduled to be published in October 2016 and effective in December 2016. 36Department of Health and Human Services, National Institutes of Health, NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. 37According to CDC and NIH officials, they do not currently have an expected date for the issuance of the next edition of the BMBL manual. Page 21 GAO-16-642 Inactivation of Pathogens would consider the results of the new select agent regulations to inform the changes made to their own documents, as they relate to inactivation. Without the ability to easily identify incidents involving incomplete inactivation on reporting forms, the Select Agent Program and NIH are unable to easily search their databases to know the frequency and causes of incidents related to the pathogens they regulate. In addition, without a clear and consistent definition of inactivation across key federal guidance, researchers may not know when to include incomplete inactivation in an incident report, potentially affecting the number of incidents reported to the Select Agent Program and NIH (for recombinant pathogens). Collectively, these issues prevent these agencies from knowing the extent to which incomplete inactivation occurs and whether these incidents are being properly identified, analyzed, and addressed. Not knowing the magnitude of the problem may inhibit their ability to achieve program missions of investigating any incidents in which noncompliance may have occurred. The 21 incidents involving incomplete inactivation from 2003 through 2015 that we identified occurred at different types of high-containment laboratories—specifically federal laboratories, academic institutions, and private companies.38 In addition, these incidents involved all methods of inactivation—including irradiation, chemical, and physical (e.g., heat) inactivation—and a variety of pathogens (see fig. 3). Our review identified some similarities in the 21 identified incidents involving incomplete inactivation, with just over half of the cases occurring at federal laboratories, over a third of incidents involving Bacillus anthracis, and about three-quarters of the incidents involving chemical inactivation. According to agency officials, none of the incidents involving incomplete inactivation identified in this report resulted in human infection, severe illness, or death. Because the total number of times inactivation is conducted in each laboratory is unknown, it is impossible to determine the 38The 21 incidents include the 10 incidents reported to us by the Select Agent Program and the additional 11 incidents that we identified that occurred from 2003 through 2015 and were confirmed by the Select Agent Program. The similarities between incidents discussed in this report cannot be generalized beyond the scope of these 21 incidents. In discussing examples throughout this report, we are only identifying the DOD and CDC laboratories whose incidents involving incomplete inactivation are known to the general public through public reports. Identified Incidents Involving Incomplete Inactivation Occurred at a Variety of
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