The use of a systems approach offers a preventative risk management alternative to mandatory phytosanitary treatment and is useful in situations where traditional phytosanitary inspection and certification may be considered ineffective or inefficient.
The integrated measures making up the systems approach may be applied throughout the supply chain, and include parties from the producer to the National Plant Protection Organization (NPPO) of the exporting country. At least two of the measures must act independently.
As the NPPO of the importing country, the CFIA is responsible for setting and communicating technically justified phytosanitary import requirements to be addressed by the systems approach.
Integrated measures are generally developed and implemented by the NPPO of the exporting country for the production and export of materials which must meet the phytosanitary import requirements of Canada. When the NPPO of the exporting country wishes to employ a systems approach, they will present a proposal to the CFIA. The NPPO must be able to demonstrate the efficacy of the proposed provisions and should approve and oversee the places of production that use the integrated measures.
End-point inspection may be used as part of the efficacy verification process, but should not be one of the independent measures of the systems approach. Measures employed in the systems approach should be primarily preventative rather than reactive.
The CFIA will evaluate the proposal for technical soundness and may make a variety of responses, including:
- Accept the proposal.
- Make recommendations to the NPPO for changes to the proposal.
- Accept the proposal contingent on an on-site review and/or trial period.
- Reject the proposal.
The CFIA's assessment of the proposed systems approach may include reviewing the system used by the exporting country's NPPO to approve places of production and to conduct audits. The CFIA may ask the NPPO of the exporting country to provide reports on audits undertaken in the exporting country.
The CFIA may audit the systems approach. These audits are intended to verify the effectiveness of the systems approach and may include documentation review, inspection of consignments and, if deemed necessary, site visits or any other activity which verifies the effectiveness of the systems approach.
The CFIA approves the system administered by the exporting NPPO. When the CFIA audits an individual facility, it is the systems approach administered by the NPPO which is being audited. The individual facility results may affect the acceptance of the systems approach administered by the NPPO.
A formal bilateral workplan may be developed to describe the technical details of the systems approach and to signal the CFIA's and exporting country NPPO's acceptance of the phytosanitary requirements.
General integrated measures
The NPPO of the exporting country may approve a place of production and/or a packing facility that complies with general integrated measures. The NPPO should register approved facilities, maintain a list of these facilities and provide the list to the CFIA upon request. The following elements should be considered by the NPPO as part of the approval process:
- Up-to-date plan of the place of production.
- Production, treatment, handling and storage records.
- Access to a plant protection specialist with a well-established working knowledge of pest identification and control.
- Designated contact person for communication with the NPPO of the exporting country.
- Examinations of plant products and places of production by designated personnel as necessary, at appropriate times and according to information and protocols provided by the NPPO of the exporting country.
- Records of examinations, including a description of pests found and corrective actions taken.
- Specific pest risk management measures where necessary and documentation of these measures.
- Notification of the NPPO of the exporting country if any pests regulated in the country of import are observed.
- Establishment and documentation of a system of sanitation and hygiene.
Additional integrated measures in situations related to specific pests
In situations where general integrated measures alone are not sufficient to prevent the risk associated with the identified quarantine pests, the NPPO of the exporting country should consider additional integrated measures. The CFIA may require some or all of the following additional measures.
Plants and plant products should be packed in a manner that prevents infestation by regulated pests.
Packaging material should be clean and free of pests, and meet the phytosanitary import requirements.
Conveyances used to move plants and plant products should be examined and cleaned as necessary prior to loading.
Each lot in a consignment should be identified in a way that can be traced back to the place of production and packing facility.
Internal audits should be conducted to ensure that the producer is in compliance with its manual. Internal audits should focus on whether the manual and its implementation meet the requirements of the CFIA.
If any critical non-conformity is detected, the NPPO must be notified and all exports to Canada from that facility must be suspended. Immediate corrective actions should be taken under the supervision of the NPPO of the exporting country. Exports may only resume when the NPPO determines that Canada's phytosanitary requirements are being met.
Responsibilities of the exporting country's NPPO
- Communicate Canada's import requirements to registered producers and packers in the exporting country.
- Develop and set up requirements for the integrated measures and systems approach program.
- Approve and register places of production and packing facilities (if applicable).
- Provide oversight of the systems approach program and conduct external audits, as required.
- Carry out phytosanitary certification to attest that all plant products exported to Canada meet the CFIA's phytosanitary import requirements.
- Provide the CFIA with information on the export program, including a list of registered facilities and notification of any suspensions.
- Notify the CFIA of finds of quarantine pests and changes in pest status in the exporting country.
- Facilitate CFIA site visits and audits.
Non-compliance and reinstatement
A. Individual facility
Non-compliances may be detected during internal audits, external audits, or as a result of examinations of plants and plant products. The place of production and/or packing facility should have its approval withdrawn and exports should be immediately suspended if the NPPO of the exporting country finds a critical non-compliance, identifies multiple (or repeated) non-critical non-compliances, finds that corrective actions are not completed within the specified time period, or receives a notification from Canada of an interception of a regulated pest on imported product.
Once an audit by the NPPO of the exporting country has confirmed that the non-compliance has been corrected, the NPPO should notify the CFIA of the facility's reinstatement. The corrective actions may require a change to the requirements of the systems approach and should include measures to prevent recurrence of the non-compliance identified.
An approved production site or packing facility that is not able to maintain the required phytosanitary conditions, does not implement corrective actions in a timely manner, or is found to be purposefully violating any condition of the systems approach will be advised in writing by the NPPO of the exporting country that their material no longer meets Canada's import requirements and their exports be suspended for the remainder of the shipping season.
B. Systems approach
Detections of regulated pests or repeated non-compliant shipments entering Canada may result in a suspension of the entire systems approach program by CFIA.