Biocontainment and Certification Program

Frequently Asked Questions

Q1: I do not work in a Veterinary facility and/or I don't work with animals, why do I have to meet the "Containment Standards for Veterinary facilities" and certify my level 3 laboratory?

Compliance with the Containment Standards for Veterinary Facilities is listed as a condition on animal pathogen import permits. CL3 facilities must be certified by the Canadian Food Inspection Agency (CFIA) before a permit will be issued to import animal or zoonotic pathogens.

Q2: What requirements must be met before a CL3 facility will be certified by the CFIA?

Physical and operational requirements for biocontainment are described in the Containment Standards for Veterinary Facilities. The documents below have been developed to assist CL3 facilities in determining compliance with the Containment Standards for Veterinary Facilities:

• Certification Submission Requirements Form
• CL3 physical and operational checklists
• CL3 Drawings Checklist
• CL3 Standard Operating Procedures (SOPs) Checklist

Q3: What is the process for CL3 facility (laboratory, small and large animal facility as well as post mortem room) certification?

The steps to be followed for the certification of a CL3 facility are as follows (click to view the certification flowchart).

• Fill out and send Contact Information Form A to the Office of Biohazard Containment & Safety:
  
  Canadian Food Inspection Agency
  Office of Biohazard Containment and Safety
  1400 Merivale Road
  Ottawa, Ontario
  K1A 0Y9
  Fax: 613-773-6521
• If zoonotic agents will be imported then the facility will need to comply with the both the Containment Standards for Veterinary Facilities (1996) and the Laboratory Biosafety Guidelines (2004). Based on the information submitted in Form A, either the CFIA or the PHAC will be assigned "lead role" and will be the point of contact throughout the certification process.
• Before construction, all specifications and drawings (including architectural, plumbing, mechanical and electrical plans) and Standard Operating Procedures should be reviewed by CFIA (and by PHAC for zoonotic agents). In some instances, it may be beneficial to conduct an on-site pre-inspection during the construction stage.
• Following the construction phase, a complete certification submission must be sent to our office. This submission must include: 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.
  • A complete list of submission requirements are described in 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)
  • CL3 Drawings Review Checklist
  • CL3 Standard Operational Procedure Checklist
• Please note that a period of two months is usually required to review the final submission. Following the submission review, the CFIA (and PHAC for zoonotic agents) will inspect the facility.
• When CFIA (and PHAC for zoonotic agents) has verified that your facility meets all physical and operational CL3 requirements then a letter will be sent to confirm certification.
• CL3 facilities are recertified annually. Re-certification requirements can be found 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).

Q4: What documentation must I submit to the Office of Biohazard Containment & Safety in order to certify my CL3 facility?

The documents below must be submitted for review:

• Contact Information Form A
• Drawings and specifications of the facility
• All items covered in 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)

Q5: I am building a new CL3 laboratory and would like to know when I should contact CFIA?

In order to avoid potential problems and confusion, please contact us early in the planning phase. Working collaboratively with the CFIA will help the facility to comply with the appropriate requirements, and should reduce any delays in the certification of your facility. Refer to Answer 3 and to the CL3 Work Flow for more details.

Q6: The construction phase of my CL3 is completed, when can I expect it to be certified?

If the drawings and specifications have already been approved by the CFIA (and by PHAC for zoonotic agents) and if a complete certification submission has been sent to our office (see Answer 3 to know what comprises a complete submission), then the review of the certification submission can take from 2 to 4 weeks per agency (therefore a total period of 4 to 8 weeks). If the drawings and specifications were not previously provided to CFIA then deficiencies may be identified that could delay certification or require costly changes. An on-site inspection of the CL3 facility is also required before it can be certified. The final inspection will be scheduled based on the facility staff's and the CFIA's availability, and as such, no specific time line has been established. An inspection report will be sent by CFIA within one week of the site visit. If all the requirements are met by the facility then a certification letter will be issued.

Q7: How do I keep my certification active?

To keep an active certification, CL3 facilities must send a complete re-certification submission to our office on a yearly basis. Re-certification submission must include all items covered 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)

Q8: When should I send my re-certification submission?

The re-certification submission should be sent at least 2 months prior to the certification expiration date. For example, if your facility was certified on June 5th, 2004 then a complete re-certification submission should be sent to our office early April 2005.

Q9: Can I import animal pathogens if my CL3 facility was certified or re-certified more than one year ago?

A facility may not import any CL3 pathogens if it was not certified or re-certified within the last year.

Q10: What do I do if my certification has lapsed (i.e. It has been more than 12 months since the lab was last re-certified)?

If you plan on continuing working with animal and/or zoonotic pathogens risk 3, then a complete recertification submission (requirements covered in Form C) must be sent to our office for review as soon as possible.

Q11: Do I need to meet the physical and operational requirements of both the Laboratory Biosafety Guidelines and the Containment Standards for Veterinary Facilities?

CL3 facilities that import zoonotic agents must meet the physical and operational requirements of the Containment Standards for Veterinary Facilities (1996) and the Laboratory Biosafety Guidelines (2004).

Q12: Do I need to send the certification submission to both offices?

No, the submission must only be sent to the lead agency (either the CFIA or the PHAC). The lead agency will provide the other agency with the pertinent information.

Q13: What requirements apply to facilities working with prions?

Facilities importing prion disease agents must meet the physical and operational requirements described in the Containment Standards for Laboratories, Animal Facilities and Post Mortem Rooms Handling Prion Disease Agents.

Q14: Will SOPs for my facility be reviewed annually?

CFIA will not re-review Standard Operating Procedures unless there has been a "program change". Modified procedures should be provided for review.

Q15: What is considered to be a "program change" and what are the steps to follow in this situation?

A "program change" in a containment level 3 facility is considered to be a change in the nature of work, pathogens used, or procedures employed that would increase the risk of exposure to workers or the potential for escape of pathogens from the facility. A program change includes any divergence from the conditions listed on the import permit. Examples of program changes that require review by CFIA include the following:

1. Moving from work with a non-aerosol transmitted pathogen (eg. rabies virus) to an aerosol-transmitted pathogen (eg. Brucella abortus).
2. Moving from work with an indigenous animal pathogen (eg. Mycobacterium bovis) to a non-indigenous animal pathogen (eg. highly pathogenic avian influenza). Note: additional physical and operational requirements exist for work with non-indigenous animal pathogens.
3. Moving from work with infected small animals (eg. animals housed in microisolators) to work with large animals (ie. animals housed in cubicles that provide primary containment).
4. Moving from work with a pathogen in vitro to in vivo.

Any program change must be reported immediately to our office. Proposed program changes must be submitted in writing by the biosafety officer and reviewed by the CFIA before they may be implemented. Once all the procedures have been reviewed and issues resolved then a letter will be sent confirming that it now meets the operational requirements.

Q16: How much does certification cost?

Currently there is no fee for containment laboratory certification or re-certification.