Biocontainment and Certification Program

Certification Process

When thinking of renovating or building a new containment level 3 (CL3) facility, the Contact Information Form A must be completed and sent to the Office of Biohazard Containment & Safety.

According to the program intent and the pathogen list submitted in Form A, either the Canadian Food Inspection Agency (CFIA) and/or the Public Health Agency of Canada (PHAC) will certify the containment level 3 facility. One agency will act as a lead and will be the main point of contact throughout the certification process. Facilities must comply with the physical and operational requirements in the Containment Standards for Veterinary Facilities (1996) for imported animal pathogens and the Laboratory Biosafety Guidelines (2004) for imported human pathogens. Once the lead agency has been identified, that agency will be the main point of contact throughout the certification process.

Before construction begins, it is imperative that all specifications and drawings (including architectural, plumbing, mechanical and electrical plans) are reviewed by CFIA and PHAC. In some instances, it may be beneficial to conduct an on-site pre-inspection during the construction stage.

Ideally, standard operating procedures (SOPs) should be provided early in the process. Biosafety Specialists from both agencies will review the SOPs to determine whether they are consistent with the operational requirements of a CL3 facility. It is strongly recommended that you start writing these procedures as soon as possible, as they are key to designing a facility that will meet your needs. The preparation of these SOPs is time consuming and should be initiated early to avoid delaying certification of the facility.

Once the construction phase is complete, a complete certification submission will be required, including: the final as-built drawings, the architectural, plumbing, mechanical and electrical plans and specifications, the validation test reports and the final version of your SOPs. For a complete list of items to address in your submission, refer to Form B: Document Submission Requirements for the Certification Performance and Verification Testing of Containment Level (CL) 3 Laboratories in Accordance with the Canadian Food Inspection Agency, Containment Standards for Veterinary Facilities, 1996 (and Public Health Agency of Canada, Laboratory Biosafety Guidelines, 2004 where applicable).

The Containment Level 3 Drawings Review Checklist as well as the Containment Level 3 Standard Operational Procedure Checklist are tools provided to evaluate completeness of the submission.

Two months is usually required for the submission review at which time the CFIA and PHAC will conduct a physical inspection of the facility.

When CFIA and PHAC have verified that CL3 physical and operational requirements have been met then a letter will be sent to confirm certification. Facilities are re-certified annually. Re-certification requirements are described in Form C: Document Submission Requirements for the Re-Certification Performance and Verification Testing of Containment Level (CL) 3 Laboratories in Accordance with the Canadian Food Inspection Agency, Containment Standards for Veterinary Facilities, 1996 (and Public Health Agency of Canada, Laboratory Biosafety Guidelines, 2004 where applicable).

CL 3 Facilities Certification Flow Process

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Facilities Certification Flow Process

For further information on the Biocontainment and Certification Program, please consult our Frequently Asked Questions.