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unknown for several reasons, including the inability to easily identify such incidents in existing databases. For those that are known, incidents occurred at federal, academic, and private high-containment laboratories and involved a range of inactivation methods and pathogens. The total number of incidents involving incomplete inactivation that occurred from 2003 through 2015 is unknown for three reasons: (1) the inability to easily identify incidents involving incomplete inactivation within incident databases, (2) the absence of reporting requirements for pathogens that are not select agents or recombinant pathogens, and (3) the absence of a clear, consistent definition of inactivation.24 First, the Select Agent Program and NIH do not have the ability to easily identify incidents involving incomplete inactivation because their incident reporting forms are not structured to specifically identify this type of 24Officials from HHS noted that another reason that the total number of incidents involving incomplete inactivation is unknown is because some incidents may remain undetected if there are no resulting infections or viability testing is not performed. The Total Number of Incidents Involving Incomplete Inactivation of Pathogens Is Unknown The Total Number of Incidents Is Unknown Due to an Inability to Easily Identify Incidents and the Absence of Reporting Requirements and a Consistent Definition Inability to Easily Identify Incidents Page 14 GAO-16-642 Inactivation of Pathogens incident. As a result, neither the Select Agent Program nor NIH (for the oversight of recombinant pathogens) was able to provide us with an accurate number of all incidents involving incomplete inactivation that occurred from 2003 through 2015. Specifically, registered entities are required by federal regulation to report any incidents of theft, loss, or release of select agents to the Select Agent Program, where “release” refers to any instance where pathogens are outside of primary containment, such as an accidental spill of viable pathogens or an incident that results in medical surveillance following an exposure, including those resulting from incomplete inactivation. The Select Agent Program is required to annually report to Congress only on the number and type (e.g., “theft” or “release”) of all incidents that have occurred involving select agents. Select Agent Program officials initially told us that there were 10 incidents involving incomplete inactivation reported to the program from 2003 through 2015 (see table 2). NIH officials initially told us that they were unaware of any incidents involving incomplete inactivation involving recombinant pathogens that had occurred in that time frame. Table 2: Ten Incidents Involving Incomplete Inactivation of Select Agents from 2003 through 2015 Initially Provided to GAO by the Federal Select Agent Program Laboratory type Pathogen Pathogen type Method of inactivation Year of incident Federal Bacillus anthracis Bacteria Irradiation 2015 Academic Venezuelan equine encephalitis virus Virus Chemical 2015 Federal Bacillus anthracis Bacteria Chemical 2014 Federal Ebola virus Virus Chemical 2014 Academic Brucella abortus, Brucella melitensis & Brucella suis Bacteria Chemical 2012 Private Eastern equine encephalitis virus Virus Chemical 2010 Federal Bacillus anthracis Bacteria Chemical 2007 Federal Bacillus anthracis Bacteria Chemical 2006 Federal Botulinum neurotoxin producing species of Clostridium Bacteria Chemical 2006 Private Bacillus anthracis Bacteria Physical 2004 Source: GAO analysis of information from the Federal Select Agent Program, 2016. | GAO-16-642 Page 15 GAO-16-642 Inactivation of Pathogens However, upon review of the Select Agent Program’s database of reported incidents, we identified another 11 incidents that involved incomplete inactivation from 2003 through 2015, which we confirmed with the Select Agent Program, in addition to the original list of 10 they provided to us (see table 3). Table 3: Eleven Additional Incidents Involving Incomplete Inactivation of Select Agents from 2003 through 2015 Identified by GAO and Confirmed by the Federal Select Agent Program Laboratory type Pathogen Pathogen type Method of inactivation Year of incident Academic Burkholderia pseudomallei Bacteria Physical 2014 Private Francisella tularensis Bacteria Chemical 2014 Federal Francisella tularensis Bacteria Chemical 2011 Private Bacillus anthracis Bacteria Physical and Chemical 2010 Private Marburg virus and Ebola virus Virus Chemical 2009 Federal Bacillus anthracis Bacteria Physical 2008 Academic Francisella tularensis Bacteria Physical and Chemical 2008 Federal Francisella tularensis Bacteria Chemical 2007 Academic Francisella tularensis Bacteria Chemical 2007 Federal Bacillus anthracis Bacteria Chemical 2006 Federal Venezuelan equine encephalitis virus Virus Chemical 2006 Source: GAO analysis of information from the Federal Select Agent Program, 2016. | GAO-16-642 Page 16 GAO-16-642 Inactivation of Pathogens According to officials, the Select Agent Program is not required to specifically report the number of incidents involving incomplete inactivation, as a subset of incidents of theft, loss, or release, to any outside entity. Therefore, identifying this subset of incidents in the database was difficult because reporting forms used to track the theft, loss, and release of select agents are not
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