On Dec. 20, 2024, the National Institutes of Health Office of Science Policy provided new guidance on the risk group designation for SARS-CoV-2. This guidance aligns with the updated recommendations from the Centers for Disease Control and Prevention.

In May 2020, based on the data available at the time, the CDC issued interim laboratory biosafety guidelines for handling and processing specimens associated with coronavirus disease 2019 at Biosafety Level 3 (BSL-3). After the CDC issued its interim guidelines, the Office of Science Policy released companion guidance aligning with the CDC's assessment. The guidance stated that SARS-CoV-2 should be considered a Risk Group 3 (RG3) agent.

After reviewing current pathogen characteristics and population impact, the Centers for Disease Control and Prevention is updating its biosafety guidance. It now recommends that work with SARS-CoV-2 be conducted at Biosafety Level 2 (BSL-2) at a minimum. The National Institutes of Health is aligning with this guidance by rescinding the interim risk group classification, stating that SARS-CoV-2 should now be considered a Risk Group 2 (RG2) agent. Under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, other than SARS-CoV and Middle East Respiratory Syndrome (MERS-CoV), which are specifically listed as RG3 agents in Appendix B-III-D, all other coronaviruses, including SARS-CoV-2, are classified under the existing RG2 category for coronaviruses in Appendix B-II-D.

Additional guidance on biosafety considerations for research involving SARS-CoV-2 is available on the Office of Science Policy website. Questions related to the National Institutes of Health guidelines may be sent to NIHGuidelines@od.nih.gov

Additional guidance on Biosafety Considerations for Research Involving SARS-CoV-2 is available on the Office of Science Policy website.  Questions related to the National Institutes of Health guidelines may be addressed to NIHGuidelines@od.nih.gov.