The labs working to protect the United States from hazardous pathogens are themselves in need of oversight updates, according to the U.S. Government Accountability Office (GAO), owing to several lapses in safety.
The labs in question–overseen by the Federal Select Agent Program–amount to more than 200 facilities throughout the United States. However, as one example, the GAO discovered that under the overseeing program, some labs are allowed to provide their own oversight, leading to potential conflicts of interest and reduced safety. Indeed, the GAO determined that the Select Agent Program fails to meet key elements of its oversight duties.
“Safety lapses continue to occur at some of the 276 laboratories in the United States that conduct research on select agents—such as Ebola virus or anthrax bacteria—that may cause serious or lethal infection in humans, animals, or plants, raising concerns about whether oversight is effective,” the report said.
In their findings, released this week, the GAO determined that the Select Agent Program lacks independence from the labs it oversees, nor has it assessed the risks this poses. Further, it pointed to expert and lab representative opinions that the program has failed to target the highest-risk activities due to lack of assessments. It does not even have joint strategic planning documents to guide its oversight, the report noted.
One area they did note was improving was the program’s efforts to hire additional staff and improve training regimens, but even this came with caution. Workforce and training gaps remain, they said.
In turn, GAO made 11 recommendations for the improvement of the program, based on reviews of relevant laws, regulation, guidance and interviews with experts and Select Agent Program officials, as well as evaluation of other countries’ effectiveness in this area. These recommendations include improved independence through documented reporting structures, the establishment of control activities and regular risk assessments of the program’s structure and effectiveness (and coupling those assessments with mitigating actions).
They also recommended improvements to the ability to perform reviews through development and implementation of plans to identify which lab activities have the highest safety and security risks–and then working to target them. Transparency was another issue, which GAO said needed to be addressed through determination of what additional information should be shared with registered labs. The last major category though was the improvement of technical expertise and countering fragmentation. GAO noted the need for a joint workforce plan that evaluated needs for the program as a whole.