The U.S. Government Accountability Office (GAO) released a report on Wednesday on high-containment laboratories and how improved oversight of dangerous pathogens is needed to mitigate any potential risks.
The GAO report said the total number of incidents involving incomplete inactivation, a process that destroys the hazardous effects of pathogens while keeping certain characteristics for future use, from 2003 to 2015 is unknown for a variety of reasons. One key reason was due to the select agent program, under the direction of the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Agriculture (USDA), that does not require laboratories to identify such incidents on reporting forms.
The GAO report said that several challenges affect the implementation of inactivation in high-containment laboratories, including gaps in scientific knowledge and limited guidance. The GAO added that the select agent program did not consistently refer incidents involving incomplete inactivation for further investigation and enforcement of violations of select agent regulations.
The GAO report recommended that HHS and the USDA improve oversight of the select agent program’s inactivation by revising reporting forms, improve guidance for development and validation of inactivation protocols, and develop consistent criteria for enforcement of incidents involving incomplete inactivation.
Both the USDA and HHS agreed with the GAO report recommendations.