IP Grams

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.

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.

We are sharing this information with all current U.S. permittees working with infectious biological agents or substances so that all are aware of the new requirement. Please note that this Interim Final Rule has implications for anyone currently holding or working with these materials and will require action on their part in order to comply with 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.  Comments on the Interim Final Rule should be submitted via the regulations.gov website; a direct link is available hereexternal icon.

Page last reviewed: November 2, 2021, 03:33 PM