	The Total Number of Incidents Involving Incomplete Inactivation of Pathogens Is Unknown

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 in  incident databases; (2) the absence of reporting requirements for  pathogens that are not select agents; and (3) the absence of a clear,  consistent definition of inactivation. We identified  additional incidents that the Select Agent Program and NIH did not initially  identify. Moreover, experts at our meeting noted  that this can make it difficult to understand when an incident occurs. We also recommended that they revise reporting forms to  help identify when incidents involving incomplete inactivation occur and  analyze the information reported to help identify the causes of incomplete  inactivation to mitigate the risk of future incidents. Gaps in Science and Limited Guidance Affect the Implementation of Inactivation in High-Containment Laboratories

Several challenges affect the implementation of inactivation in high- containment laboratories, including (1) limited scientific information for  developing and implementing inactivation protocols, (2) limited federal  guidance for developing inactivation protocols, (3) inconsistent  implementation of safeguards to help ensure inactivation is properly  conducted, and (4) varied documentation requirements for shipping  inactivated material. We concluded that without more  comprehensive and consistent federal guidance on the development and  validation of inactivation protocols, protocols will vary in their scientific  soundness and effectiveness, increasing the risk that inactivation may not  be achieved. The Select Agent Program Inconsistently Referred Violations and Enforced Regulations Related to Incidents Involving Incomplete Inactivation

The two agencies that comprise the Select Agent Program—CDC and  APHIS—did not consistently refer incidents involving incomplete  inactivation for further investigation and enforcement to the HHS Office of  Inspector General or APHIS’s Investigative and Enforcement Services. We found, however, that CDC and APHIS did not use the  same set of criteria for referring violations for investigation by the HHS  Office of Inspector General or APHIS’s Investigative and Enforcement  Services. Select Agent Program officials and an expert from our group  noted that the Select Agent Program is independent in its oversight of  HHS labs since it organizationally exists in a separate part of the  department from the HHS agencies that have high-containment  laboratories. GAO Contact and Staff Acknowledgments

For further information on this testimony, please contact Timothy M.  Persons, Chief Scientist, at (202) 512-6522 or personst@gao.gov or John  Neumann, Director, Natural Resources and Environment, at   (202) 512-3841 or neumannj@gao.gov.
Why GAO Did This Study

This testimony summarizes the information contained in GAO's September 2016 report, entitled ( GAO-16-642 ).
or John Neumann at (202) 512-3841 or neumannj@gao.gov .

What GAO Found

The total number of incidents involving incomplete inactivation--a process to destroy the hazardous effects of pathogens while retaining characteristics for future use--that occurred from 2003 through 2015 is unknown for several reasons. One key reason is that the Select Agent Program--operated by the Departments of Health and Human Services (HHS) and Agriculture (USDA) to oversee certain dangerous pathogens, known as select agents--does not require laboratories to identify such incidents on reporting forms. According to the program, 10 incidents occurred from 2003 through 2015. However, GAO identified an additional 11 incidents that the program did not initially identify. Because the program cannot easily identify incidents involving incomplete inactivation, it does not know the frequency or reason they occur, making it difficult to develop guidance to help mitigate future incidents. The 21 identified incidents involved a variety of pathogens and laboratories, as shown below.
Several challenges affect the implementation of inactivation in high-containment laboratories, including gaps in scientific knowledge and limited guidance. For example, there is limited federal guidance for researchers on the development and validation of inactivation protocols. Validation helps ensure protocols are scientifically sound and produce consistent results. Due to limited guidance, laboratories varied in their interpretation of validated methods of inactivation, resulting in researchers applying differing levels of rigor. Without more comprehensive guidance, as called for by experts, protocols will vary in their scientific soundness, increasing the risk of incomplete inactivation.
The Select Agent Program did not consistently refer incidents involving incomplete inactivation for further investigation and enforcement for violations of select agent regulations. For example, the program referred incidents involving incomplete inactivation at various laboratories, but did not refer two incidents in 2014 that occurred at HHS. A memorandum of understanding between HHS and USDA states that the program should handle incidents consistently. GAO found, however, that the program does not have a consistent, written set of criteria for handling incidents. Without such criteria, the program risks inconsistent enforcement of select agent regulations. This further highlights GAO's previous finding that existing federal oversight of high-containment laboratories is fragmented and self-policing.