An investigation by a federal watchdog agency has found an additional 21 incidents of improperly inactivated biological agents, according to a report released last week.
The Government Accountability Office report comes after Dugway Proving Ground was found to have shipped 575 samples of live Bacillus anthracis to 194 laboratories over a 12-year period.
Although none of the 21 new incidents occurred at Dugway, the local military installation is mentioned throughout the 71-page report, including references to the Department of Defense review that led to the cessation of manufacturing of anthrax and other biological agents at the facility to outside laboratories.
Of the 21 additional incidents of inadvertent live shipments, only 10 were originally reported by the Select Agent Program, which oversees dangerous pathogens like Ebola and anthrax, in the review’s 12-year window. The 11 other incidents were discovered by the GAO during its review.
From the incidents identified between 2003 and 2015, 11 occurred at federal laboratories, with the remaining 10 split evenly between private and academic labs. Bacillus anthracis, the bacteria which causes anthrax, was improperly inactivated in eight of the incidents; other agents included the viruses responsible for Ebola and equine encephalitis, as well as the bacteria responsible for tularemia.
The GAO report said the total number of incidents involving improperly inactivated agents is unknown because the Select Agent Program doesn’t require labs to identify those incidents in reporting forms.
“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 GAO report said.
In findings that mirrored the Dugway review completed last December, the GAO found gaps in scientific knowledge and a lack of federal oversight on how individual laboratories attempt to make biological agents inert.
Following the inadvertent shipments at Dugway, DOD is investigating best practices to render Bacillus anthracis inert using radiation, according its December review of the failings at the facility. Pathogens handled by the Select Agent Program can be inactivated using heat, filtration, irradiation and chemicals.
Chemical deactivation was the most common method used in the 21 cases of incomplete inactivation, as it was used in 15 of the cases reported by GAO. Two of the incidents occurred at the Centers for Disease Control and Prevention, including a June 2014 incident when researchers transferred supposedly inactivated Bacillus anthracis from a high-containment lab to a lower safety level laboratory to test detection equipment.
As many as 70 staff members at CDC could have been exposed to anthrax through the viable sample in that incident, the report said.
In December 2014, CDC researchers inadvertently switched samples of live Ebola virus with samples intended for study of the inactivated agents.
The GAO report found laboratories used varied methods to validate if a biological agent had been inactivated. The report also showed the Select Agents Program does not have consistent, written criteria for dealing with incidents of improper inactivation of the biological agents its laboratories handle.
“This further highlights GAO’s previous finding that existing federal oversight of high-containment laboratories is fragmented and self-policing,” the report said.
Six of the 21 identified incidents were the result of issues with inactivation protocols, when researchers followed the protocols of other labs without testing the protocols or verifying their effectiveness, the report said.
In its recommendations, GAO said the Select Agent Program needs to create clear inactivation definitions for its laboratories and revise its reporting forms to identify when incomplete inactivation occurs, to better understand why it occurs.
GAO also recommended the departments of Health and Human Services and Agriculture work on research to better understand the science behind inactivation and viability testing. The agency also suggested improving the guidelines for shipping inactivated biological agents.