Biocontainment compliance and certification

The Canadian Food Inspection Agency (CFIA) verifies compliance of biocontainment facilities handling or storing:

  • terrestrial animal pathogens
  • aquatic animal pathogens
  • plant pathogens and pests

Compliance is evaluated to ensure containment requirements, as described in appropriate standard(s), are met.

All facilities importing or handling the CFIA-regulated pathogens and pests must hold a valid CFIA Compliance or Certification Letter for the appropriate containment level and type. Lower containment facilities are evaluated through a compliance verification program using a self-assessment inspection checklist while higher containment facilities undergo a more in-depth certification program.

Compliance Letters and Certification Letters are issued to specific room number(s) and are not facility wide. Validity periods vary in range from up to 1, 2 or 3 years based on the type and level of containment. The facility must maintain its valid compliance status as long as it still possesses the CFIA-regulated materials.

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Containment standards

Safe handling of terrestrial animal pathogens, aquatic animal pathogens and plant pests in laboratories and containment zones.

Overview of compliance verification program

The CFIA's Office of Biohazard Containment and Safety (OBCS) evaluates lower containment facilities through a compliance verification program using a self-assessment inspection checklist that evaluates if the physical and operational containment requirements, as described in appropriate containment standard(s), are met.

Conducting the inspection of the containment zone(s) and completing the inspection checklist is to be done with both a laboratory representative and the facility's biological safety officer (BSO) present. Completed checklists are submitted to the National Centre for Permissions (NCP) (formerly known as the Centre of Administration for Permissions) for processing. If the applicant demonstrates that the facility meets the necessary requirements, a Compliance Letter will be issued and valid for up to 2 years.

Overview of certification program for higher containment facilities

The OBCS evaluates higher containment facilities through a certification program that evaluates if the physical and operational containment requirements, as described in appropriate containment standard(s), are met.

The evaluation process includes, but is not limited to:

  • evaluation of program intent (for example, list of intended pathogens, animal species and work activities)
  • assessment of as-built facility drawings and specifications
  • review of biosafety manual (BSM), standard operating procedures (SOPs), overarching risk assessments and local risk assessments (LRA)
  • review of performance and verification test reports (PVTRs)
  • review of enhanced oversight requirements (for facilities handling Category I and II foreign or emerging animal diseases)
  • on-site inspection and testing

Note: on-site inspection, commissioning testing, drawings and specifications review, are generally not part of the recertification process unless changes have been made or new risks identified.

Facilities will require the collaboration of a diverse group of individuals to complete the various activities and stages of the certification and recertification processes. Senior management, laboratory manager, biological safety officer, research scientists, technical staff, animal care staff, quality assurance, facilities management and external contractors all have an important role to play and should be involved early on and throughout the process.

Certification and recertification process

The process for certification and recertification is the same for all types of high containment facilities. Summary documents for terrestrial, aquatic, plant and diagnostic network laboratories have been developed to outline the specific minimum requirements necessary to demonstrate compliance for certification and recertification.

The following flowchart outlines the various steps in the certification and recertification process. The main differences between the certification and recertification process are that the recertification process is completely linear (that is, no back and forth) whereas the certification process indicates that more back and forth is required between the facility and the OBCS (for example, the BSM and SOP usually requires multiple reviews before being finalized) and an on-site inspection is also required.

Flow chart. Description follows.
Flow chart – Text version

The flowchart outlines the process for certification and recertification. First answer the question, Does the containment zone hold an active Certification Letter for the program intent? If the answer is No, the facility must follow the certification process. If the answer is Yes, recertification is necessary. Certification requires the following documentation to be provided:

(1) contact information and program intent; (2) as-built drawings and specifications; (3) the Biosafety Manual (BSM) and associated standard operating procedures (SOPs) and (4) Performance and Verification Test Reports (PVTR). Whereas, recertification requires contact information, program intent and PVTR be submitted. As-built drawings and specifications and the Biosafety Manual and associated SOPs are only submitted for recertification if there have been modifications made to containment or essential equipment or systems; or if there are new or updated BSM or SOPs. The Office of Biohazard Containment and Safety will review the documents and send a report requesting any additional information or clarification necessary to complete their evaluation. Once the facility submits the requested information, the OBCS reviews the submission and determines if there are any outstanding issues or non-compliances. During the certification process, a request for more information or documentation is requested to address any issues. During the recertification process, if there are non-compliances a Non-Compliance report is issued. The facility then has the opportunity to submit any additional information or documentation requested or they must submit a Corrective Action Plan in response to a Non-compliance report. Once all issues have been dealt with, an on-site inspection may follow. Once the facility demonstrates that they meet all the physical and operational requirements, testing and commission requirements, a Certification Letter is issued. A Certification Letter is not guaranteed. There are instances where certification is not granted.

The time necessary to complete the review process depends on a variety of factors such as the complexity of the facility, dual agency (the CFIA and the Public Health Agency of Canada (PHAC)) oversight, the quality and completeness of submissions and current workloads.

If you are planning to build a containment facility or make upgrades to an existing facility, please contact the OBCS early in the planning phase. Working collaboratively with the OBCS will help ensure compliance with the appropriate requirements and should reduce delays in the certification of your facility.

Facilities need to plan to ensure that all testing is completed on an annual basis (that is before testing expiry date). Moreover, facilities must maintain their valid compliance status as long as they still possess the CFIA-regulated materials. To avoid project interruptions or delays in receiving permits to import, facilities should plan ahead and make sure documentation is submitted well before their certification expiry date. It is recommended that documentation required for renewal be submitted at least 1 to 2 months before the expiry of their current Certification Letter.

Program intent

Program intent is intended to provide critical information to the OBCS regarding the containment zone and its intended use. The program intent will identify details like:

  • specific room numbers that are part of the containment zone and containment barrier as well as their intended use
    • for example, small animal room, cell culture room, postmortem, wash up area
  • type of facility (federal, provincial, public health or hospital, academic, private) and if there are modifications
    • for example, new construction, upgrade to an existing facility, renovations, other
  • general types/purpose of work anticipated
    • for example, research, diagnostic, large scale production, vaccine development and testing
  • list of pathogens or pests anticipated to be handled or stored by the containment zone
  • list of animal species anticipated, as well as intended number of each
  • identification of activities which may pose a risk
    • for example, any aerosol generating procedures or maximum volumes to be handled

The OBCS will review and approve proposed work, pathogen and pest list, as well as animal species.

Program intent changes

Proposed changes to the containment zone's program intent must be reviewed and approved before they may be implemented.

Any intended changes must be submitted to the OBCS with the necessary supporting documentation (for example, updated SOPs, decontamination validation). Once all the testing and operational updates have been reviewed and approved, confirmation of changes will be communicated by the OBCS.

Examples of program changes include, but are not limited to:

  • addition of new pathogens, strains or pests
  • moving from work with a pathogen from in vitro only to in vivo
  • moving from work with small animals in primary containment caging to work with large animals
  • addition of new animal species
  • addition of activities which can generate aerosols

Facility changes and/or operational procedure changes

Proposed changes to the containment zone's physical components and/or operational procedures that may affect containment, biosafety or biosecurity must be reviewed and approved before they may be implemented. Any intended changes must be submitted to the OBCS with the necessary supporting documentation (for example, project submissions, schematics, testing reports, SOPs, etc.). Once all the proposed updates have been reviewed and approved, confirmation of changes will be communicated by the OBCS.

Examples of physical facility and/or operational procedure changes include, but are not limited to:

  • physical changes or renovations to containment zones
  • changes to control systems (for example, sequence of operation) or emergency generator (for example, load, transfer time)
  • replacing old equipment with new equipment
  • addition of new equipment
  • changes to existing operational procedures
  • implementation of new operational procedures

Inspections

We conduct inspections of regulated containment facilities to verify compliance with the Health of Animals Act and its regulations (HAA/HAR), Plant Protection Act and its regulations (PPA/PPR), permit conditions, approved work activities, and the appropriate physical and operational containment requirements.

In preparation for on-site inspections and to help ensure inspector safety, facilities are required to complete and return the Summary S1 – Pre-approval for on-site inspection to the OBCS. This form is available from the OBCS Biocontainment and Certification Program (biocon@inspection.gc.ca) until made available online.

Lower containment

As part of the compliance monitoring and verification program, the OBCS may inspect the following lower containment facilities:

  • Containment Level 2 (CL2)
  • CL2-Agriculture (CL2-Ag)
  • CL2 with CL3 operational requirements (CL2+CL3 Ops)
  • Aquatic Containment Level 2 (AQC2) in vitro only
  • Aquatic Containment in vivo small scale (AQCss)

Depending on the size and complexity of the facility, on-site inspections typically take 1/2 day or 1 day and usually consist of an opening meeting, documentation review, walkthrough and verification of the containment zone and a final closing meeting.

To facilitate compliance verification and the inspection process, facilities are asked to provide a biosafety overview during the opening meeting that highlights previous, current, and future projects. They may also be asked to have various documents on hand for inspectors including such things as overarching and LRA, biosafety manual (BSM) and associated SOPs, training records, regulatory authorizations, pathogen inventory, decontamination validation results, inspection reports, incident reports and testing and maintenance records.

A verbal summary of inspection findings will be presented by the inspectors on-site as part of the closing meeting. A formal inspection report detailing non-compliances (if any) and corrective action timelines will be issued.

Currently there is no fee for inspections conducted by the OBCS.

Please contact your local CFIA office or the Invasive Alien Species and Domestic Program (CFIA-IAS_ACIA-EEE@inspection.gc.ca) for questions related to the inspection of Plant Pest Containment (PPC) Display, PPC Level 1 (PPC-1) and PPC-2 containment zones.

Higher containment

Higher containment facilities undergo an on-site inspection as part of initial certification processes. On-site inspections or visits may also be conducted when there are changes in program intent, renovations or updates, containment failures or as part of Enhanced Oversight for facilities handling Category I and II Foreign or Emerging Animal Disease (FAD or EAD) agents.

Depending on the size and complexity of the facility, inspections typically take 1 to 2 days and usually consist of an opening meeting, documentation review, walkthrough and verification of the containment zone and support areas, heating, ventilation and air conditioning (HVAC) and control system failures and a final closing meeting.

The walkthrough and verification activities will confirm the information provided in the certification submission including such things as the presence, location, type and testing of various physical requirements like seals and penetrations, interlocking doors and emergency egress overrides, communication devices, primary containment devices (for example, Biological Safety Cabinets (BSCs), decontamination technologies, backflow preventers and high efficiency particulate air (HEPA) housings and filters.

Where directional airflow is required, it will be verified at critical containment doors and the face of Class II Type B2 BSCs during normal operations and various failure scenarios (for example, supply and exhaust fan failures, power failure, etc.). The response and accuracy of audible and visual alarms during failures will also be verified.

A verbal summary of inspection findings will be presented by the inspectors on site as part of the closing meeting. A formal inspection report will be issued detailing any outstanding physical or operational containment requirements that need to be addressed before being granted certification or the requested program change.

Currently there is no fee for inspections conducted by the OBCS.

Virtual and hybrid inspections

On-site inspections and visits remain a key tool in helping the OBCS to deliver essential compliance verification and certification activities.

The OBCS is working on developing virtual and hybrid (that is, with virtual and on-site components) inspection processes and tools aimed to provide flexibility and minimize impact on containment facilities in meeting their regulatory requirements without compromising the OBCS' ability to verify and assess compliance.

As the processes become established, the OBCS will provide information on how to prepare for a virtual or hybrid inspection including various ways to demonstrate compliance virtually (for example, pictures or videos or live stream).

Verification requirements for facilities handling terrestrial animal pathogens

Facilities working with terrestrial animal pathogens must meet the appropriate physical containment and operational practice requirements as described in the Canadian Biosafety Standard (CBS).

The OBCS will determine if imported material under its authority (see When to apply) is to be handled in a CL2, CL2 (prion), CL3 or CL4 facility as defined in the CBS and the CFIA's Policy on the Importation of Terrestrial Foreign or Emerging Animal Disease Agents into Canada by External Facilities.

Containment Level 2

The CFIA has regulatory authority over CL2 and CL2-Ag facilities working with terrestrial animal pathogens under its authority (see When to apply).

In some cases, CL2 zones may be required to meet CL3 operational requirements (CL2+CL3 Ops). The condition is added to permits when there is a potential increase in the release of or exposure to infectious materials. Examples include:

  • the animal pathogen(s) being handled are more easily transmitted
  • the proposed activities pose a higher risk
    • for example, significant generation of aerosols or large volumes
  • the products come from countries of risk and can potentially carry risk group 3 (RG3) and RG4 organisms

The Guidance Document for Containment Level 2 Facilities with CL3 Operational Requirements outlines the additional operational requirements needed to protect workers and minimize the potential spread of the disease to Canada's animal resources. This document is available from the NCP (permission@inspection.gc.ca) until made available online.

We evaluate these facilities through the Compliance Verification Program and Compliance Letters are valid for up to 2 years. Inspections may be conducted.

Containment Level 2 inspection checklists

  • Inspection Checklist for Level 2 In Vitro Only Containment Zones including Addendum 1: Containment Level 3 Operational Requirements (use if working with terrestrial animal pathogens and/or aquatic animal pathogens)
  • Inspection Checklist for Containment Level 2 In Vivo – Small Animal Zones
  • Inspection Checklist for Containment Level 2-Agriculture In Vivo – Large Animal Zones

These documents are available from the NCP (permission@inspection.gc.ca) until they are made available online.

Any questions related to Containment level 2 facilities should also be directed to the NCP (permission@inspection.gc.ca).

Containment Level 3 and Containment Level 4

The CFIA has regulatory authority over CL3, CL3-Ag and CL4 facilities working with terrestrial animal pathogens under its authority (see When to apply).

The OBCS evaluates these facilities through the Certification Program and our Policy on the Importation of Terrestrial Foreign or Emerging Animal Disease Agents into Canada by External Facilities. Certification Letters are valid for up to 1 year.

CL3 and CL4 certification and recertification documents

  • Summary C1 – Contact Information and Program Intent
  • Summary C2 – CL3 and CL3-Ag Certification Submission Requirements
  • Summary C3 – CL3 and CL3-Ag Recertification Submission Requirements
  • Summary C4 – CL3 and CL3-Ag Biosafety Manual Checklist
  • Summary C5 – CL3 and CL3-Ag As-Built Drawings and Specifications
  • Summary C7 – CL4 Recertification Submission Requirements
  • Summary C8 – CL4 Biosafety Manual Checklist
  • Summary C10 – Additional Submission Requirements for Enhanced Oversight
  • Summary – HVAC and Control System Failure Testing Requirements

These documents are available from the OBCS' Biocontainment and Certification Program (biocon@inspection.gc.ca) until they are made available online.

Any questions related to CL3, CL3-Ag and CL4 facilities should also be directed to the Biocontainment and Certification Program (biocon@inspection.gc.ca).

Verification requirements for facilities handling aquatic animal pathogens

Laboratories working with aquatic animal pathogens must meet the appropriate physical containment and operational practice requirements as described in the Containment Standards for Facilities Handling Aquatic Animal Pathogens (CSFHAAP).

The CFIA will determine which of the following containment types the imported material is to be handled in:

  • Aquatic Containment Level 2 in vitro only (AQC2 in vitro)
  • Aquatic Containment in vivo small scale (AQCss)
  • Aquatic Containment Level 2 in vivo full scale (AQC2 in vivo)
  • Aquatic Containment Level 3 in vivo full scale (AQC3 in vivo)

An aquatic Compliance or Certification Letter may be used in support of a request to import susceptible aquatic animals. Please visit Aquatic Animal Imports for more information.

An aquatic Compliance or Certification Letter may be used to support the domestic movement of non-imported aquatic animals. Please visit Aquatic Animal Domestic Movements for more information.

Aquatic containment in vitro only

If aquatic animal pathogens are used for in vitro purposes only, the work can be performed in a CFIA approved AQC2 facility.

We evaluate these facilities through the Compliance Verification Program and Compliance Letters are valid for up to 2 years. On-site inspections may be conducted.

Aquatic level 2 inspection checklist

Inspection Checklist for Level 2 In Vitro Only Containment Zones (use if working with aquatic animal pathogens and/or terrestrial animal pathogens) is available from the NCP (permission@inspection.gc.ca) until fillable forms are made available online.

Please contact the NCP for any questions related to aquatic in vitro only facilities.

Aquatic containment in vivo small scale

The CFIA evaluates AQCss facilities through the Compliance Verification Program and Compliance Letters are valid for up to 1 year. Compliance Letters for AQCss containment zones that have well developed compliance history or have been inspected may be considered for a validity period up to 2 years.

Please refer to the Guidance Document for Aquatic Containment In Vivo Small Scale (AQCss) Facilities for additional information regarding small scale facilities and requirements. This document is available from the OBCS' Biocontainment and Certification Program (biocon@inspection.gc.ca) until made available online.

Aquatic containment in vivo small scale checklist

Inspection Checklist for Aquatic Containment In Vivo Small Scale (AQCss) Facilities is available from the OBCS' Biocontainment and Certification Program (biocon@inspection.gc.ca) until fillable forms are made available online.

Any questions related to AQCss facilities should also be directed to the Biocontainment and Certification Program (biocon@inspection.gc.ca).

Aquatic containment in vivo full scale

The CFIA evaluates aquatic containment in vivo full scale facilities through the Certification Program and Certification Letters are valid for up to 1 year.

AQC2 and AQC3 in vivo certification and recertification documents

  • Summary A1 – Contact Information and Program Intent
  • Summary A2 – AQC2 In Vivo Certification Submission Requirements
  • Summary A3 – AQC2 In Vivo Recertification Submission Requirements
  • Summary A4 – AQC2 In Vivo Biosafety Manual Checklist
  • Summary A5 – AQC2 In Vivo As-Built Drawings and Specifications
  • Summary A6 – AQC3 Certification Submission Requirements
  • Summary A7 – AQC3 Recertification Submission Requirements
  • Summary A8 – AQC3 Biosafety Manual Checklist
  • Summary A9 – AQC3 As-Built Drawings and Specifications
  • Summary – HVAC and Control System Failure Testing Requirements

These documents are available from the OBCS Biocontainment and Certification Program (biocon@inspection.gc.ca) until they are made available online.

Any questions related to AQC in vivo facilities should also be directed to the Biocontainment and Certification Program (biocon@inspection.gc.ca).

Verification requirements for facilities handling plant pests

Laboratories working with microorganisms and invertebrates that are injurious to plants (that is plant pests) may be required to meet the appropriate physical containment and operational practice requirements as described in the Containment Standards for Facilities Handling Plant Pests (CSFHPP). The CSFHPP may apply to both imported organisms and to organisms obtained within Canada (that is domestically acquired).

The CFIA will determine which of the following containment types the organisms are to be handled in:

  • Plant Pest Containment Display (PPC-Display)
  • Plant Pest Containment Level 1 (PPC-1)
  • Plant Pest Containment Level 2 (PPC-2)
  • Plant Pest Containment Level 2 Arthropods (PPC-2A)
  • Plant Pest Containment Level 3 (PPC-3)

The CFIA regulates the handling of imported and domestically acquired plant pests. Please visit Importing and Handling Invertebrates and Micro-organisms for more information on regulatory requirements and related processes.

Lower plant pest containment zones

For facilities that require PPC-Display, PPC-1 or PPC-2 in response to an import or domestic request to import or handle plant pests, the CFIA evaluates these facilities through the Plant Pest Containment Program.

As part of the application process, we inform the applicant of the required PPC level and the associated physical and operational requirements, as well as assist and guide the applicant through the facility approval process. Depending on the PPC level, a facility's PPC status is normally valid for 1 to 3 years.

Any questions related to PPC-Display, PPC-1 and PPC-2 should be directed to your local CFIA office or the Invasive Alien Species and Domestic Program (CFIA-IAS_ACIA-EEE@inspection.gc.ca).

Higher plant pest containment zones

The CFIA evaluates PPC-2A (Arthropods) and PPC-3 facilities through the Certification Program and Certification Letters are valid for up to 2 years for PPC-2A or up to 1 year for PPC-3.

PPC-2A and PPC-3 certification and recertification documents

  • Summary P1 – Contact Information and Program Intent
  • Summary P2 – PPC-2A Certification Submission Requirements
  • Summary P3 – PPC-2A Recertification Submission Requirements
  • Summary P4 – PPC-2A Biosafety Manual Checklist
  • Summary P5 – PPC-2A As-Built Drawings and Specifications
  • Summary P6 – PPC-3 Certification Submission Requirements
  • Summary P7 – PPC-3 Recertification Submission Requirements
  • Summary P8 – PPC-3 Biosafety Manual Checklist
  • Summary P9 – PPC-3 As-Built Drawings and Specifications
  • Summary – HVAC and Control System Failure Testing Requirements

These documents are available from the OBCS Biocontainment and Certification Program (biocon@inspection.gc.ca) until they are made available online.

Any questions related to PPC-2A or PPC-3 facilities should also be directed to the Biocontainment and Certification Program (biocon@inspection.gc.ca).

Verification requirements for diagnostic network laboratories

Animal health network diagnostic laboratories across Canada that provide early detection and rapid response to animal disease threats are required to meet the appropriate physical containment and operational practice requirements as described in the Foreign Animal Disease Diagnostic Laboratory Containment Standard for FAD Diagnostic Network Laboratories and the CBS for transmissible spongiform encephalopathy (TSE) Diagnostic Network Laboratories.

The CFIA evaluates FAD Network and TSE Network Facilities through the Certification Program and Certification Letters are valid for up to 2 years.

FAD Diagnostic Network Facilities certification and recertification documents

  • Summary C1 – Contact Information and Program Intent
  • Summary F2 – FAD Network Certification Submission Requirements
  • Summary F3 – FAD Network Recertification Submission Requirements
  • Summary F4 – FAD Network Biosafety Manual Checklist
  • Summary F5 – FAD Network As-Built Drawings and Specifications
  • Summary – HVAC and Control System Failure Testing Requirements

TSE Diagnostic Network Facilities certification and recertification documents

  • Summary C1 – Contact Information and Program Intent
  • Summary T2 – TSE Network Certification Submission Requirements
  • Summary T3 – TSE Network Recertification Submission Requirements
  • Summary T4 – TSE Network Biosafety Manual Checklist
  • Summary T5 – TSE Network As-Built Drawings and Specifications

These documents are available from the OBCS Biocontainment and Certification Program (biocon@inspection.gc.ca) until they are made available online.

Any questions related to FAD or TSE Network facilities should also be directed to the Biocontainment and Certification Program (biocon@inspection.gc.ca).

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