Entities' Experiences and Perceptions of Reporting the Theft, Loss, and Release of Select Agents or Toxins to CDC
WHY WE DID THIS STUDY
Congress and the media have devoted attention to several events at laboratories involving the theft, loss, or release (TLR events) of select agents and toxins that have the potential to pose severe threats to public health, such as anthrax or smallpox. Entities that work with select agents and toxins must report TLR events to the Federal Select Agent Program (FSAP), which is jointly managed by the Department of Health and Human Services' CDC-specifically, CDC's Division of Select Agents and Toxins (DSAT)-and the U.S. Department of Agriculture's Animal and Plant Health Inspection Service.
CDC requested that we collect information on entities' experiences and perceptions of reporting TLR events. The request was spurred by our May 2017 report, CDC Generally Met Its Inspection Goals for the Federal Select Agent Program; However, Opportunities Exist To Strengthen Oversight (OEI-04-15-00430), which found that almost 3 of every 4 entities (201 of 275) reported no TLR events over the 3 year period from 2013 through 2015. DSAT expressed concern that entities with no reported TLR events for multiple years may be underreporting them and may pose more of a risk than entities that regularly report TLR events.
HOW WE DID THIS STUDY
Using data from the National Select Agent Registry (NSAR), we obtained data from 21 entities that had received a Registration Renewal inspection in 2015. We received Web-based survey responses from these 21 entities, providing information about their experiences in reporting TLR events and their perceptions of obstacles to reporting, actions to encourage reporting, and benefits from reporting. We also used NSAR data to obtain the observations that DSAT identified in its inspections from 2013 through 2015 related to the requirement to report TLR events. Finally, we analyzed FSAP regulations, as well as FSAP and DSAT policies and guidance documents, to understand the TLR reporting requirements and DSAT's oversight of them.
WHAT WE FOUND
We found that all 21 entities in our review had been registered with the FSAP for at least 6 years, and that two-thirds of them had reported at least 1 TLR event to the FSAP while the remaining one-third had never reported a TLR event. None of the 21 entities in our review sample had inspection observations that indicated any failure to report TLR events. Half of the entities in our review said that obstacles to reporting TLR events include a fear of negative consequences and a burdensome, restrictive reporting process. CDC may be able to better encourage the reporting of TLR events by addressing these obstacles; improving entities' training and guidance; and further fostering a culture of safety within the FSAP that encourages such reporting.
WHAT WE CONCLUDE
Although our earlier study found that nearly 3 of every 4 entities did not report a single TLR event from 2013 through 2015, we found no evidence to indicate that the 21 entities in our review are underreporting TLR events. In addition, this report identifies obstacles to reporting TLR events and actions to encourage such reporting that coincide with many of DSAT's ongoing efforts to improve oversight in this area.