What’s New: 2022
Today, the Federal Select Agent Program (FSAP) published its seventh annual report of aggregate program data, the 2021 Annual Report of the Federal Select Agent Program. The report summarizes data for calendar year 2021 and is part of FSAP’s continued efforts to provide the American public with insight into the regulatory activities of the program. The annual publication of this report reflects FSAP’s ongoing commitment to transparency. As in previous years, the content includes a look at the regulatory functions of FSAP, as well as compliance with the select agent regulations at laboratories across the nation. This year’s report provides insight into key ways the program has adapted to carry out its mission during the COVID-19 pandemic, as well as highlights FSAP’s efforts to engage with the regulated community throughout the year to ensure regulatory compliance.
Once again, the content of the report underscores that overall, most laboratories registered with the program are compliant with the regulations, and none of the small number of reported incidents during the year resulted in a significant risk to public or agricultural health.
The report summarizes aggregate program data in areas such as:
- Numbers and types of registered entities, as well as amendments to registrations
- Top registered select agents or toxins
- Security risk assessments performed
- Number of inspections conducted
- Key observations related to inspection findings and compliance with the select agent regulations
- Reported thefts, losses, and releases of select agents or toxins
- Identifications and transfers of select agents or toxins
- Publications and outreach activities
Today, the Federal Select Agent Program (FSAP) is pleased to announce the publication of its annual analysis of inspection report timeliness data, the 2021 Federal Select Agent Program Inspection Report Processing Annual Summary.
Inspection reports play a critical role in ensuring the safety and security of work with select agents and toxins. Timely feedback following an inspection is essential so that FSAP can quickly get important information back to entities, therefore allowing the entities to promptly address any identified concerns.
The new FSAP analysis finds continued program success in providing timely feedback to entities following an inspection, with nearly all final inspection reports sent to entities in 2021 within the program’s goal of 30 business days.
Key findings include the following:
- FSAP issued 201 final inspection reports in 2021 – with 99 percent of those (199/201) issued within the target timeframe of 30 business days. The average was 20 days.
- The Centers for Disease Control and Prevention’s Division of Select Agents and Toxins issued 168 final inspection reports at an average of 20 days, and the Animal and Plant Health Inspection Service’s Division of Agricultural Select Agents and Toxins issued 33 final inspection reports at an average of 17 days.
- All 6 immediate action observations were issued within the target timeframe of 10 business days. The average was 7 days.
Throughout 2021, FSAP continued to implement key changes to the inspection process due to the COVID-19 pandemic, including the use of multiple types of inspections to best meet the needs at each entity. Beginning in April 2020 and continuing into 2021, FSAP adjusted its inspection processes by adopting remote or hybrid (i.e., part on-site and part remote) inspections, due to travel restrictions and for the safety of FSAP inspectors and regulated entity staff, in addition to on-site inspections. These changes did not adversely impact timeliness or result in delays in issuing inspection reports, but rather, helped FSAP to become more efficient and continue to carry out its program mission despite the pandemic. Moving forward, FSAP will continue to use all available inspection types as needed and appropriate.
Today, the Federal Select Agent Program (FSAP) is announcing the Centers for Disease Control and Prevention’s publication of a Federal Register Notice seeking public comment on a draft policy statement that describes verification requirements for Biosafety Level 4 (BSL-4)/Animal BSL-4 laboratory facilities, including heating, ventilation, and air conditioning (HVAC) systems testing. The requirements are intended to assist individuals and entities in verifying that facility design parameters and operational procedures are functioning as intended to meet the biosafety requirements in the select agent and toxin regulations (42 CFR 73.12(b)).
Comments on the Federal Register Notice should be submitted via the regulations.gov website; more information is available here. Public comments on the policy will be accepted until March 21, 2022.