Updated: January 2025

Containment Requirements (Biosafety Level)

In May 2020, based on the data available at that time, the CDC issued Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 at Biosafety Level 3 (BSL3). Following CDC’s issuance of its Interim Guidelines, the NIH Office of Science Policy (OSP) issued companion guidance aligned with CDC’s assessment through its interim laboratory biosafety guidance stating that SARS-CoV-2 should be considered as a Risk Group 3 (RG3) agent.  

December 2024 Update: After careful review of current pathogen characteristics and population impact, CDC is updating its biosafety guidance, now recommending that work with SARS-CoV-2 be conducted at BSL2 at a minimum, and NIH is aligning by rescinding the interim RG classification such that SARS-CoV-2 should be considered a RG2 agent.  In the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines), 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 NIH OSP website.

SARS-CoV-2 is a positive strand RNA virus, work with extracted genetic material will require strict adherence to BSL-2 containment requirements.

IBC Protocol Submissions

All research with SARS-CoV-2 is subject to Wayne State University Institutional Biosafety Committee (IBC) oversight. IBC review and approval are required prior to receipt and initiation of any work with materials containing SARS-CoV-2 virus or derived from COVID-19 patients. IBC review will require submission of a Standard Operating Procedure (SOP) for the proposed research. In addition, some research will also require approval by the IRB or the IACUC.

Under the updated guidelines, local IBCs have been directed by the NIH Office of Science Policy to consider SARS-CoV-2 to be a Risk Group 2 agent as a starting point in their risk assessments when reviewing research subject to the NIH Guidelines. Any research that involves the use of recombinant or synthetic nucleic acid molecules coding for SARS-CoV-2 full genome, or individual genes of interest, must be approved by the IBC.

All IBC submissions for work involving SARS-CoV-2 must be submitted through the WSU e-Protocol platform¹. 

Technical Expertise/Personnel Requirements

Laboratory personnel must be provided with appropriate training and laboratory experience in working with human pathogens prior to being permitted to work with materials containing potentially active SARS-CoV-2 or full-length genomic RNA from SARS-CoV-2. 

Inclusion of students (graduate and undergraduate) on IBC protocols that include materials containing potentially active SARS-CoV-2 or full-length genomic RNA from SARS-CoV-2 will be reviewed and assessed on a case-by-case basis by the IBC. Principal Investigators will be required to outline the training to be provided to undergraduates, including who is providing the training, a step wise demonstration of proficiency at low risk procedures prior to proceeding to procedures deemed to have higher risk, and subsequent documentation of all related training. The safety track record of Principal Investigators will be taken into consideration when determining the eligibility of students to work with SARS-CoV-2 materials.

Minors (anyone under the age of 18) will not be permitted to work on SARS-CoV-2 related wet-lab research. Please review the OEHS Minor’s in Research Facilities Program materials for additional information.

Individuals in high-risk groups such as those who are immunosuppressed or who have medical conditions that might contribute to negative outcomes if infected by SARS-CoV-2 must be advised on the potential impacts of working with SARS-CoV-2.  Consultation with a an occupational health specialist is available upon request.

Individuals working with SARS-CoV-2 virus must monitor their health and immediately report any potential illness, especially fever, cough, shortness of breath or flu-like symptoms to their PI/lab director and the IBC (IBC@wayne.edu). Individuals working with SARS-CoV-2 will be offered the COVID vaccine, or boosters, as necessary throughout the course of their related research.

Supplementary Information and References

IBC Review:

The IBC will review all work for consistency with the CDC Guidelines² and the American Biological Safety Association (ABSA) International³ guidance document, as well as the biosafety practices and policies described in the Biosafety in Microbiological and Biomedical Laboratories⁴ (BMBL, 6th Edition) publication. The WSU IBC will consider these the minimum standard and can request more stringent containment requirements if deemed necessary for the research being proposed.

When considering applying for permission to work with SARS-CoV-2 related materials it is recommended that investigators read the original documents for:

• Updated guidance and recommendations from these organizations
• Additional details on the type of engineering controls required in specific laboratory settings, and
• Requirements specific to sample types and/or associated procedures.
• ABSA International has additional relevant laboratory/research resources available in their SARS-CoV-2/COVID-19 Toolbox⁵.

Facility Inspections

All BSL-2 facilities listed in the IBC application, including those involving currently designated BSL-2 facilities, are subject to inspection for compliance with BSL-2 practices and procedures⁶ as a part of the review process. Specific activities may require "BSL-2 with enhancements". This term refers to the implementation of BSL-3 practices in a BSL-2 facility. Any work that requires "BSL-2 with enhancements" will need to clearly state in the protocol submission what enhancements are being employed in the BSL-2 facility. All facilities must be completely set-up, with all required engineering controls, PPE, disinfectants (as described in the IBC protocol) in place at the time of the inspection. 

Links and References

1. e-Protocol Applications: https:/research.wayne.edu/oehs/bio-safety/new-applications
2. CDC Interim Guidance for Laboratories: https://www.cdc.gov/covid/php/lab/index.html
3. ABSA International Guidance Document: https://absa.org/topic/regs-standards-guidelines/
4. Biosafety in Microbiological and Biomedical Laboratories (BMBL, 6th Edition), CDC/NIH: https://www.cdc.gov/labs/BMBL.html
5. ABSA International COVID-19 Toolbox: https://absa.org/covid19toolbox/
6. WSU BSL-2 Inspection: https://research.wayne.edu/oehs/bio-safety/resources