After several recent incidents involving the shipment of dangerous pathogens that cause infectious diseases, such as the bacterium that causes anthrax, which were believed to be inactivated and potentially could have exposing people, the Government Accountability Office (GAO) was tasked “to evaluate issues related to inactivation of pathogens in high-containment laboratories."
In its 71-page audit report released this week, GAO stated, “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 reported having “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.”
GAO determined that numerous “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.”
But, GAO stated, “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.”
GAO further noted that, “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 the program should handle incidents consistently.”
GAO found, however, that the program does not have a consistent, written set of criteria for handling incidents. And “without such criteria, the program risks inconsistent enforcement of select agent regulations.”
GAO noted that, “This further highlights GAO’s previous finding that existing federal oversight of high-containment laboratories is fragmented and self-policing.”
GAO made six recommendations to HHS and USDA “to, among other things, improve the Select Agent Program’s oversight of inactivation by revising reporting forms, improving guidance for development and validation of inactivation protocols and developing consistent criteria for enforcement of incidents involving incomplete inactivation.
Both HHS and USDA agreed with GAO’s recommendations.
