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 accept 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.
If you have any questions, please contact CDC’s Division of Select Agents and Toxins at
lrsat@cdc.gov or 404-718-2000.
