Monkeypox virus: Laboratory licensing

The Public Health Agency of Canada (PHAC) is monitoring the mpox (monkeypox) outbreak to provide Canadians with evidence-based information and guidance. In addition to the Monkeypox virus (MPXV) Biosafety Advisory, the following information was compiled by the Centre for Biosecurity to help support our stakeholders in understanding and meeting their regulatory obligations with respect to MPXV.

Any questions or comments can be sent to biosafety.biosecurite@phac-aspc.gc.ca.

Licensing requirements for work with MPXV

• Laboratories with a Pathogen and Toxin Licence for work with Risk Group 3 (RG3) human pathogens including security sensitive biological agents (SSBAs) will need to submit an amendment to add MPXV (if not already included) to their existing RG3 Human Pathogen including RG3 SSBA Licence via the PHAC's Biosecurity Portal.
• Laboratories with a Pathogen and Toxin Licence for work with RG3 human pathogens not including SSBAs will need to submit a new licence application for a Pathogen and Toxin Licence authorizing RG3 including SSBAs in order to work with MPXV. This can be done via the PHAC's Biosecurity Portal. An associated Human Pathogens and Toxins Act (HPTA) Security clearance application will also need to be submitted. It is recommended to submit as early as possible as this is a rate-limiting step for issuing a licence authorizing work with SSBAs.

As part of the licensing process, the organization may be required to submit additional documentation to demonstrate compliance with the conditions of the licence, which includes adhering to the applicable requirements described in the Canadian Biosafety Standard for Containment Level 3 (CL3).

Reactivation and licensing of Containment Level 3 (CL3) laboratories for work with MPXV

Laboratories previously certified for CL3 activities currently being used for lower containment level activities (e.g., CL2) are encouraged to reach out to the Centre for Biosecurity at biosafety.biosecurite@phac-aspc.gc.ca to obtain the best possible guidance on the requirements for reactivation and subsequent HPTA licensing of the CL3 laboratory to work with MPXV.

Please include the following in your correspondence:

• What type of work is expected to be done with MPXV? In vitro and/or in vivo?
• Is any work with RG3 human pathogens other than MPXV planned in this laboratory?
• Was this laboratory initially certified as a CL3 laboratory work area only, a CL3 small animal containment zone or a CL3 large animal containment zone?
• Has this laboratory been issued a Pathogen and Toxin Licence authorizing controlled activities with an SSBA?
• Which Canadian Biosafety Guideline(s)/Standard(s) was this laboratory initially certified to?

This information is necessary in determining the compliance documentation that will need to be submitted and potential performance and verification testing that may need to be completed in order for the PHAC to authorize an RG3 Pathogen and Toxin Licence for work at CL3. Additionally, an HPTA Security Clearance and review of the organization's Biosecurity Plan is required for issuing an SSBA licence.