The “high-containment laboratories” are overseen by the U. S. Department of Health and Human Services via the Centers for Disease Control and Prevention and the U.S. Department of Agriculture through its Animal and Plant Health Inspection Service (APHIS).
However, in a recent report to Congress, the federal Government Accountability Office said APHIS needs to better coordinate its actions with the CDC to improve oversight of hazardous pathogens covered by the “Select Agent Program.” In addition to certain foodborne pathogens, the list of pathogens covered by the program includes a wide variety of bacteria, viruses and poisonous substances such as anthrax, Ebola and ricin.
The effectiveness of safety controls at labs handling select agents has been in the spotlight in the past three years.
“For example, in November 2016, the Department of Homeland Security discovered that a private laboratory had inadvertently sent a toxic form of ricin — a potentially lethal poison — to one of its training centers multiple times since 2011, potentially putting training participants at risk,” according to the GAO report.
“In May 2015, the Department of Defense (DOD) discovered that a DOD laboratory had inadvertently shipped live anthrax bacteria to nearly 200 other laboratories worldwide over the course of 12 years. And in July 2014, the National Institutes of Health discovered decades-old vials of smallpox in a storage room of a Food and Drug Administration laboratory on its campus.”
The accountability office found the agencies involved with the Select Agent Program have made improvements, such as hiring additional staff and sharing more information with the public and registered laboratories. Nevertheless, according to the GAO report, the program does not fully meet all key elements of effective oversight.
“For example, the program is not independent in that it is not structurally distinct and separate from all of the laboratories it oversees. Both CDC and APHIS have individually made structural changes and put mechanisms in place to reduce conflicts of interest, but the APHIS component of the program has not documented the reporting process it developed to reduce conflicts of interest,” according to the GAO report.
“Until APHIS formally documents the reporting structure for its component of the program from the APHIS director of the program to the administrator of APHIS, it will continue to appear to have conflicts of interest in its oversight of APHIS-owned laboratories.”
Also, on at least three occasions, APHIS inspected its own or other USDA laboratories, which is not in keeping with the memorandum of understanding it signed with the CDC.
Moreover, the program is not fully transparent because it shares only limited information about lessons learned and other matters with registered laboratories, and there is no consensus about what additional information should be shared.