2020 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 the Federal Select Agent Program (FSAP) can quickly get important information back to entities, therefore allowing the entities to promptly address any identified concerns.
The 2020 Federal Select Agent Program Inspection Report Processing Annual Summary, published in August 2021, provides an analysis of inspection report timeliness data during calendar year 2020. The analysis finds continued FSAP improvement in providing timely feedback to entities following an inspection, with all final inspection reports sent to entities in 2020 within FSAP’s goal of 30 business days.
Key findings for 2020 include the following:
- FSAP issued 157 final inspection reports in 2020 – with 100 percent issued within the target timeframe of 30 business days. The average was 19.5 days.
- The Centers for Disease Control and Prevention’s Division of Select Agents and Toxins issued 125 final inspection reports at an average of 21.1 days, and the Animal and Plant Health Inspection Service’s Division of Agricultural Select Agents and Toxins issued 32 final inspection reports at an average of 13.3 days.
- Nearly all (7 out of 8) immediate action observations were issued within the target timeframe of 10 business days. The average was 7 days.
FSAP made several important changes to the inspection process during the COVID-19 pandemic. Beginning in April 2020, 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. 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.
