Guidance on the Regulation of SARS‑CoV/SARS‑CoV-2 Chimeric Viruses: Regulation of SARS-CoV/SARS-CoV-2 Chimeric Viruses and Genomic Material

Since SARS-CoV/SARS-CoV-2 chimeric viruses resulting from any intentional manipulation of SARS-CoV-2 to include nucleic acids coding for SARS-CoV virulence factors are select agents, entities are required to obtain prior approval from DRSC to possess, use, or transfer these agents. Additionally, experiments to create these chimeric viruses must be submitted to the FSAP for prior approval.

Nucleic acids encoding for genetically modified select agents that can produce infectious forms of any of the select agent viruses are also regulated as select agents. This is currently limited to positive-strand RNA virus genomic material. The positive strand RNA SARS-CoV/SARS-CoV-2 genome is regulated since it is an immediate precursor to virus production. Regulation is limited to positive strand RNA forms of the viral genome that can be translated into protein precursors for virus production. Complementary DNA (cDNA) copies of the SARS-CoV/SARS-CoV-2 chimeric virus genome are not regulated because the cDNA would first need to be transcribed into RNA and translated into protein. Therefore, the cDNA would not be an immediate precursor to virus.