What’s New: 2021
Today, the Centers for Disease Control and Prevention (CDC)’s Division of Select Agents and Toxins published an Interim Final Rule adding SARS-CoV/SARS-CoV-2 chimeric viruses resulting from any deliberate manipulation of SARS-CoV-2 to incorporate nucleic acids coding for SARS-CoV virulence factors to the list of HHS select agents and toxins. In addition, the work to create this chimeric virus is a ‘restricted experiment’ and requires prior approval from CDC before performing the experiment.
The regulation, available at https://www.federalregister.gov/d/2021-25204external icon, was published in the Federal Register and CDC will be accepting public comments on the addition of the agent for the next 60 days. Comments on the Interim Final Rule should be submitted via the regulations.gov website; a direct link is available hereexternal icon.
HHS/CDC believes that immediate regulatory oversight of these experiments and the resulting chimeric viruses is essential to protect the public from the potential consequences of a release of these viruses.
Once the 60-day public comment period has closed, CDC will consider the comments received. In the meantime:
- Within 30 days of the publication of the notice in the Federal Register (by December 17, 2021), any individual or entity that possesses SARS-CoV/SARS-CoV-2 chimeric viruses resulting from any deliberate manipulation of SARS-CoV-2 to incorporate nucleic acids coding for SARS-CoV virulence factors must provide notice to the Federal Select Agent Program regarding their possession of this agent.
- By 90 days after the publication (by February 15, 2022), any individual or entity that intends to continue to possess, use, or transfer this agent will be required to either register in accordance with the select agent regulations (42 CFR part 73), or amend their current registration [in accordance with § 73.7(h)] and meet all of the requirements of the select agent regulations.
Today, the Federal Select Agent Program (FSAP) published its sixth annual report of aggregate program data, the 2020 Annual Report of the Federal Select Agent Program. The report, which summarizes data for calendar year 2020, is a part of FSAP’s continued efforts to provide the American public with insight into the regulatory activities of the program and 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. The report highlights FSAP’s efforts to engage with the regulated community throughout the year to ensure regulatory compliance. This year, it also provides insight into key changes made to program operations during the COVID-19 pandemic.
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
The full report, along with an infographic summarizing the key findings, is now available here.
Today, the Federal Select Agent Program (FSAP) is pleased to announce the publication of its annual analysis of inspection report timeliness data, the 2020 FSAP Inspection Report Processing Annual Summary.
This FSAP analysis finds continued program 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 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.
- CDC’s Division of Select Agents and Toxins issued 125 final inspection reports at an average of 21.1 days, and APHIS’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.
For more information, please see the full report.
The Federal Select Agent Program (FSAP) will host two multi-agency public webinarsexternal icon this fall to provide guidance and information regarding the submission of APHIS/CDC Form 2, APHIS/CDC Form 3 and APHIS/CDC Form 4.
The two webinars, which will each cover the same agenda, will take place at the following dates and times:
- October 6, 2021 from 10:00 am to 12:30 pm EDT
- November 3, 2021 from 1:30 pm to 4:00 pm EDT
All stakeholders from the FSAP-registered and non-registered communities are invited to attend.
Registration instructions can be found here on the FSAP website, and the webinar agenda will be posted to this same webpage once finalized. Registration is limited to the first 1000 participants.
Registration will be confirmed by email and registrants will receive a link to enter the meeting one week prior to the date of the webinar.