Hazardous agent labs report no accidental transmissions in 2015

Labs authorized to handle dangerous biological agents and toxins were adherent to regulations laid out by the Federal Select Agent Program in 2015, and reported no illness or deaths resulting from accidental exposure, according to findings from the program’s first aggregate report.

“The 2015 Annual Report of the Federal Select Agent Program (FSAP) demonstrates the program’s ongoing commitment to increasing transparency, and understanding of the work done by the Federal Select Agent Program to regulate laboratories working with select agents and toxins,” Daniel Sosin, MD, MPH, FACP, acting director of the CDC’s Division of Select Agents and Toxins, told Infectious Disease News. “The good news from this report is that the vast majority of labs are doing well in following the regulations and that in 2015, no potential exposures resulted in illness, death or transmission among those working in the labs or in the surrounding communities.”

Daniel Sosin

Managed jointly by the CDC, HHS and Agriculture Department, the FSAP regulates the use of select agents and toxins by maintaining a national registry, conducting lab inspections and enforcing compliance. Although these regulated agents represent substantial biological risks, Sosin said that enabling research through the FSAP is paramount to public health breakthroughs.

“The research done by entities that work with select agents and toxins provides important scientific discoveries that have led to improved surveillance, prevention, diagnostics and treatment options for diseases considered to be the most threatening to public health,” he said. “We know there is always some risk in working with these agents, but the FSAP has made it possible to conduct research critical to national security and public health in a safer and more secure manner by minimizing these risks.”

According to the report, 291 entities were registered with the FSAP by the end of 2015. Throughout the year, FSAP conducted 216 facility inspections and approved 463 transfers of select agents or toxins. The program approved 4,426 individuals to have access to these substances; 16 were denied.

The FSAP received notice of 199 incidents of potential occupational exposure, although none of the 908 monitored lab workers developed an illness or transmitted a virus to others. There were 12 reports of lost agents, but each was the result of clerical errors or samples mistakenly destroyed as waste.

The majority of participating labs were adherent to FSAP regulations, according to the report. The 29 facilities found in violation either agreed to participate in a corrective action plan (n = 6), were referred to another agency for investigation (n = 20) or were placed under suspension (n = 3).

“The data provide key insight into work that is conducted with biological select agents and toxins at laboratories across the nation, as well as the regulatory functions of the FSAP,” Sosin said. “[The report] represents only one part of our continued efforts to improve the program in order to enhance its ability to conduct quality oversight of laboratories.”

Reference:

CDC. 2015 annual report of the Federal Select Agent Program. http://www.selectagents.gov/resources/FSAP_Annual_Report_2015.pdf. Accessed June 30, 2016.

Disclosure: Sosin reports no relevant financial disclosures.