What’s New: 2023
Today, the Federal Select Agent Program (FSAP) is announcing the Centers for Disease Control and Prevention (CDC)’s publication of a Final Rule in the Federal Register regarding the addition of SARS-CoV/SARS-CoV-2 Chimeric Viruses to the HHS list of Select Agents and Toxins.
The Final Rule states that HHS/CDC has amended the select agents and toxins regulations to add 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. HHS/CDC also requires regulated entities to obtain prior approval from CDC to conduct deliberate manipulation of SARS-CoV-2 to incorporate nucleic acids coding for SARS-CoV virulence factors because these chimeric viruses have the potential to pose a severe threat to public health and safety.
No changes were made to the regulatory requirements in the Interim Final Rule as a result of public comments received; however, CDC has developed the Guidance on the Regulation of SARS-CoV/SARS-CoV-2 Chimeric Viruses and Frequently Asked Questions to help entities comply with the regulations.
Today, the Federal Select Agent Program (FSAP) is announcing the Centers for Disease Control and Prevention’s publication of the Notice of Availability in the Federal Register for the Policy Statement for Biosafety Level 4 (BSL-4)/Animal Biosafety Level 4 (ABSL-4) Laboratory Facility Verification. The policy statement assists individuals and entities in verifying that facility design parameters and operational procedures are functioning as intended to meet the biosafety requirements in the select agent and toxin regulations (42 CFR 73.12(b)).
A draft version of this policy was published in the Federal Register on January 19, 2022 for public comment. All comments were taken into account during the finalization of the policy; as a result of comments received, clarification was added to address HVAC operational verification, examples of major changes to the HVAC system, and what BSL-4/ABSL-4 facility verification entails and how often and when it should be performed. A full summary of the comments and responses can be reviewed in the Federal Register Notice.