Containment Standards for Facilities Handling Plant Pests
6.0 Facility certification
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When appropriate, CFIA inspectors may conduct site visits and certify that facilities meet these standards, thereby providing assurance that they can appropriately contain plant pests.
Laboratories handling plant pests should refer to chapters 3 and 4 of these Standards to verify that their operational practices and physical containment are adequate to contain the pests that will be used there. In order to receive a Permit to Import, PPC-2 and PPC-3 facilities must be certified by the CFIA. Facilities importing pests and planning work that requires PPC-2 containment may be inspected by CFIA Inspectors, and/or facility staff may be required to fill in a detailed inspection checklist. Facilities importing pests and planning work that requires PPC-2 containment may be inspected by CFIA inspectors, and/or facility staff may be required to complete a detailed inspection checklist. Facilities importing pests and planning work that requires PPC-3 containment will undergo an initial inspection by CFIA inspectors. Certifications are valid for a period of two years. If a facility is not granted certification, or certification is revoked for any reason, the deficiency or deficiencies must be corrected before the facility can be certified or re-certified.
The critical containment components to be verified during initial certification of PPC-3 facilities are provided in section 6.3. All of these components are to be verified during the commissioning of a new facility. Certification and re-certification records must be retained for three years and they must be available for review by a CFIA Inspector, who may elect to re-verify some or all of the components. All as-built drawings of the PPC-3 facility with specifications of surfaces must be submitted for review. Operational protocols must be submitted for review before work with plant pests at the PPC-3 level can be carried out. Training of personnel must be completed and documented. Users must understand containment principles and proposed procedures. Detailed records of the certification process and test reports for PPC-2 and PPC-3 facilities must kept for three years.
Re-certification of PPC-3 facilities must initially be conducted annually. Detailed records and test reports are required for re-certification and these must be retained for three years. Before program changes can be implemented at PPC-3 facilities, operational procedures must be submitted for review and approval by the CFIA. Program changes include changes related to the nature of the work or the procedures employed that would increase the risk of pest escape from the facility.
6.3 Verification and performance testing of PPC-3 facilities
6.3.1 Room integrity
Room integrity is to be verified by smoke testing the room perimeter to detect leaks. All joints, corners and sealed penetrations are to be smoke-tested for leaks.
6.3.2 Air handling systems
Particle challenge testing of HEPA filters is to be performed in situ by the particle scanning method to ensure they do not contain leaks in the filter media, the bond between the media and frame or around the frame gasket and support. Particle penetration is not to exceed 0.01%.
Ductwork systems are to be pressure decay tested to confirm that leakage rates do not exceed 0.2% of duct vol/min at 500 Pa. The American Society of Mechanical Engineers Standard N510 Testing of Nuclear Air Treatment Systems, 1995, gives procedures for testing the leak-tightness of ducts and plenums.
Room pressure control systems are to operate as specified (i.e. ensure negative pressures are maintained). Control systems are to be tested for fail-safe operation by testing for failure of system components. Alarms are to be tested for the detection of positive pressurization and air handling systems failure is to be tested by simulation of alarm conditions.
6.3.3 Fume hoods
Fume hoods and associated exhaust systems are to comply with relevant design and installation requirements and they must be tested in situ in accordance with CSA Z316.5-04, Fume Hoods and Associated Exhaust Systems (2004). Fume hoods are to comply with the requirements for HEPA filtration. The installation of a charcoal filter prior to the HEPA filter may be envisaged as a measure to protect the HEPA filter from deleterious effects of chemical vapours and also as protection for personnel performing maintenance and certification testing of the HEPA filter.
6.3.4 Biological safety cabinets
Testing and certification of BSCs shall be performed in accordance with CSA Z316.3-95 or the applicable NSF Standard. Interlocks (i.e.. Class II Type B2 BSC internal cabinet supply fan and exhaust fan) are to be tested in accordance with the applicable NSF standard. Manufacturer's requirements for airflows for BSCs must be met.
6.3.5 Emergency power
Emergency electrical generators must be tested under appropriate load conditions to ensure systems will operate as specified.
6.3.6 Surface finishes
Benches, casework, walls and floors are to be inspected to determine whether they are cleanable and can withstand decontamination methods. Where applicable, surfaces should be continuous and without seams to allow for thorough cleaning and decontamination, and penetrations must be sealed.
6.3.7 Communication devices
Where they are present, communication and electronic data transfer systems (e.g. computer, telephone, facsimile) are to be tested to ensure that they will operate as specified.
6.3.8 Access control / security devices
Security systems (e.g. controlled access) must be tested/verified to ensure that they will operate as specified.
6.3.9 Autoclaves and decontamination systems
All treatment systems (e.g. autoclaves, liquid effluent treatment systems) must be verified to ensure that they operate as specified and tested using representative loads. Biological indicators or an internal load temperature probe should be used to confirm that treatment parameters have been achieved. All other decontamination systems (e.g.. dunk tanks, gas sterilizers) are to be tested to ensure that they operate as specified. References pertaining to the maintenance and efficacy of decontamination systems and disinfectants must be kept for three years. A description of the procedure to be followed must be provided to the CFIA.
6.3.10 Effluent treatment system plumbing
Drains and associated piping leading to liquid effluent treatment systems (including associated vent lines) must be tested in accordance with Section 3.6 of the National Plumbing Code of Canada (1995).
6.3.11 Standard operating procedures
Standard operating procedures for the facility must be updated on a regular basis, and updated SOPs must be submitted to the CFIA at the time of re-certification.
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