Concerns Over US Laboratory Oversight Program

Flaws in the Current Oversight System

A recent report highlights potential flaws within the United States program responsible for overseeing laboratories engaged in research on dangerous pathogens. Numerous laboratories across the country conduct research on high-risk pathogens, including Ebola and anthrax, necessitating strict safety measures.

Government Accountability Office Review

In response to incidents indicating safety lapses, the Government Accountability Office (GAO) was tasked with reviewing the oversight mechanisms of the Federal Select Agent Program. This program, managed collaboratively by the Departments of Health and Human Services (HHS) and Agriculture (USDA), monitors laboratories involved in dangerous pathogen research.

GAO Findings and Recommendations

The GAO recently released a report detailing its findings and recommendations regarding the Select Agent Program. The report revealed that the program lacks complete independence from the laboratories it oversees, creating potential conflicts of interest. Additionally, after interviewing experts and laboratory representatives, the GAO noted that high-risk activities are often overlooked during laboratory reviews and inspections. This oversight is attributed in part to inadequate assessments of activities to identify those with the highest risk levels.

Another critical finding was the deficiency in technical expertise and trained personnel, highlighting a significant gap in necessary training for laboratory staff.

In light of these findings, the GAO proposed eleven recommendations, which include conducting risk assessments of both the program’s structure and its activities to mitigate conflicts of interest. The recommendations also emphasize the need to target high-risk activities and to develop a comprehensive workforce plan.

Both HHS and USDA have expressed agreement with the GAO’s recommendations.

References

(1) Kelly Servick. U.S. oversight of risky pathogen research has flaws, report finds. Science Magazine. http://www.sciencemag.org/news/2017/10/us-oversight-risky-pathogen-research-has-flaws-report-finds. doi:10.1126/science.aar3712.
(2) United States Government Accountability Office Report to Congressional Requesters. HIGH-CONTAINMENT LABORATORIES: Coordinated Actions Needed to Enhance the Select Agent Program’s Oversight of Hazardous Pathogens. GAO-18-145: Oct 19, 2017. Publicly Released: Oct 31, 2017. https://www.gao.gov/products/GAO-18-145.