Guidance on the Regulation of SARS‑CoV/SARS‑CoV-2 Chimeric Viruses: Example of a SARS-CoV/SARS-CoV-2 Chimeric Virus Experiment that does not meet the Definition of a Restricted Experiment

The purpose of this section is to give an example of an experiment that does not meet the definition of a restricted experiment and would therefore not require prior approval before creating the chimeric virus. If you are uncertain whether a potential chimeric virus is regulated or an experiment is restricted and requires prior approval, please contact FSAP for further guidance.

Example

An entity proposed four mutant derivative strains of SARS-CoV-2 with a series of alanine amino acid substitutions in ORF3a. The four proposed SARS-CoV-2 mutant strains containing alanine amino acid substitutions in ORF3a are not select agents. These proposed SARS-CoV-2 mutant strains are not chimeric viruses incorporating nucleic acids coding for SARS-CoV virulence factors into SARS-CoV-2 and, therefore, would not be subject to the requirements of the select agent regulations. This determination is based solely on the observation that the proposed alanine substitutions in SARS-CoV-2 ORF3a do not correspond to a homologous alanine at the same positions in SARS-CoV open reading ORF3a.