Friday, July 01, 2016

Federal Select Agent Program Issues First Annual Report


2014 was a bad year for lab safety, with several high profile incidents involving `select agents, including H5N1 & anthrax (see CDC Announces Another Serious Biosecurity Incident, Ebola (see CDC Reports Potential Ebola Exposure At Lab), and smallpox at an FDA lab in Bethesda, Md. (see CDC Media Statement on Newly Discovered Smallpox Specimens).

`Select agents’ are those pathogens that have been deemed to pose a significant biological hazard, and among those, Tier 1 select agents are considered:
`biological agents and toxins present the greatest risk of deliberate misuse with significant potential for mass casualties or devastating effect to the economy, critical infrastructure, or public confidence, and pose a severe threat to public health and safety:’

In the wake of these (and other) incidents, we saw calls for stricter controls on laboratories, a Laboratory Bio-Safety Backlash, and some heated house subcommittee hearings (see House Subcommittee Hearing on Biosafety).

Among the promises made by the CDC's director was instilling a `culture of safety' in these labs, and improved accountability and transparency when incidents do occur.

Which brings us to the first annual Federal Select Agent Program report, released yesterday in a 32 page PDF file. While not the annus horribilis that was 2014, the record wasn't without blemish.

Among their findings:

In 2015, there were 12 potential losses and 233 potential releases reported to FSAP.

12 reports of potential losses of BSAT were investigated by the FBI, and all were determined to be records management errors or were samples mistakenly autoclaved as waste.
  • Of the 233 potential releases, 199 reports were determined to represent potential occupational exposure to laboratory workers.
  • Of these 199, two were reports of seroconversions involving three laboratory staff with no known incident, and were identified by routine annual screening of laboratory staff.
  • Two reports were determined to represent potential releases of Xanthomonas oryzae.
  • Because this BSAT infects plants and is not a danger to humans, these events were not classified as potential occupational exposures but as releases outside primary containment (like a biosafety cabinet (BSC)).
  • 32 reports did not meet the regulatory criteria for a release.
None of the potential releases resulted in illnesses, deaths, or transmissions outside of laboratories into the surrounding environment.
No thefts of BSAT were reported.

Labs are not identified by name in this report (they are called `entities'),  but we do learn that 6 were identified as having `systemic biosafety and security deficiencies' and put under a CAP (Corrective Action Plan), while three others were suspended.

You'll want to read the full report, but below you'll find the media announcement from the CDC.

Federal Select Agent Program first annual report released

For Immediate Release: Thursday, June 30, 2016

The Federal Select Agent Program (FSAP) released today its first annual report of data on the regulation and oversight of laboratories that work with biological agents and toxins that have the potential to pose a severe threat to public, animal or plant health, or to animal or plant products (select agents and toxins). The report aims to improve public understanding of the work performed by these unique laboratories and how the federal government ensures this work is done as safely and securely as possible.

The report summarizes program data for 2015, including:

  •  Numbers and types of entities registered to handle select agents and toxins
  •  Security risk assessments performed and the results
  •  Number and length of inspections conducted
  •  Key observations on inspection findings and compliance with the select agent regulations
  •  Transfers of select agents or toxins
  •  Theft, loss, and release of select agents or toxins

The report is one component of efforts underway by FSAP following the Centers for Disease Control and Prevention’s (CDC) 90-day internal review, and recommendations put forward by the Fast Track Action Committee on Select Agent Regulations (FTAC-SAR).  This report demonstrates the program’s commitment to responsibly sharing data about the regulation of select agents and toxins.

The report can be found here.

FSAP is managed jointly by CDC’s Division of Select Agents and Toxins, and the Animal and Plant Health Inspection Service’s Agriculture Select Agent Services.  The program was established as part of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 to increase the security and oversight of select agents and toxins with the authority to create and enforce regulations that dictate how, where, and by whom select agents and toxins could be possessed, used, and transferred.

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