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 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 2021 Federal Select Agent Program Inspection Report Processing Annual Summary, published in July 2022, provides an analysis of inspection report timeliness data during calendar year 2021. The analysis finds continued FSAP 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 for 2021 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.

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.