The GAO investigation stemmed in part from a 2015 Department of Defense report that found researchers at its Dugway Proving Ground facility in Utah had mistakenly shipped live anthrax to almost 200 other labs across the world, including sites in Australia, Germany, Norway and South Korea.
The Defense Department labs had not fully rendered the anthrax inactive, as is required before any highly contagious — and potentially deadly — pathogen is allowed to leave a high security lab facility.
Bacteria and viruses are rendered inactive using either heat, chemicals, or radiation.
These processes kill the pathogens so they cannot spread, but keep their structure and other unique characteristics intact so personnel at labs that lack high-levels of security and containment can conduct further research.
In their broader study, a GAO investigative team led by Timothy Persons and John Neumann said 10 shipments where pathogens were not fully inactivated were documented between 2003 and 2015.
The incidents occurred at “federal, academic, and private high-containment laboratories and involved a range of inactivation methods and pathogens,” including anthrax, Ebola, and equine encephalitis. But the GAO report said “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.”
GAO’s investigators uncovered 11 incidents government oversight programs missed.
In those instances, highly infectious bacteria such as Francisella tularensis, which can cause lethal pulminary infections, and Burkholderia pseudomallei, also known as the “Vietnam time-bomb” for its association with U.S. servicemen who came in contact with the bacteria during their deployments. Both the United States and the Soviet Union studied the bacteria as a potential biological weapon.
In their report, Persons and Neumann said one key reason for the oversight gap was that a program run jointly by the Department of Health and Human Services (HSS) and the Department of Agriculture “does not require laboratories to identify such incidents on reporting forms.”
“Because the program cannot easily identify incidents involving incomplete inactivation,” investigators said, “it does not know the frequency or reason they occur, making it difficult to develop guidance to help mitigate future incidents.”
In testimony before the House of Representatives subcommittee on oversight and investigations on Friday, Persons and Neumann said there was “insufficient scientific information” available to researchers on the most effective means to render the pathogens inactive.
They said the government has offered only “limited” technical guidance on how to kill pathogens without destroying their value to researchers.
Persons and Neumann said the high-containment labs they visited did not “consistently apply safeguards,” and that documents detailing shipments of inactive pathogens varies from lab to lab.
“Without guidance for documenting the shipment of inactivated pathogens,” Persons and Neumann said, “laboratories are at risk of being unable to locate shipped pathogens in a timely manner, which is important if material thought to be inactivated is determined to still be viable.”
In both their report and testimony, Persons and Neumann made several recommendations to increase safeguards, including developing “comprehensive and consistent guidance” for labs on how to properly kill the pathogens before shipment, and developing “guidance on documenting the shipment of inactivated material.”
Both the departments of Agriculture and Health and Human Services agreed with the GAO’s recommendations.
Edward Alvaros, the Agriculture Department’s undersecretary for marketing and regulatory programs, said his department and the HHS will publish a final rule in October, 2016, that will revise the oversight program and include “regulations to provide definitions of inactivation, as well as definition of viability testing.”
Alvaros also said the final rule will “post new guidance to assist entities with the development and implementation of inactivation procedures, as well as with viability testing.”
Jim Esquea, the HSS assistant secretary for legislation, said the department has established a “Biosafety and Biosecurity Coordinating Council” to provide “a high-level and formal mechanism to coordinate and collaborate on biosafety and biosecurity issues across the department.”