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Systems approach for production of plant products

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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:

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:

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.

Place of production / packing facility manual
The NPPO of the exporting country should require that producers and packing facilities develop a manual. The manual should describe all of the requirements, elements, processes and operational systems that make up the integrated measures for pest risk management. The manual should be developed, implemented and maintained by the producer and approved by the NPPO of the exporting country.
Pest management program
The pest management program should describe procedures or processes approved by the NPPO of the exporting country and be designed to either prevent infestations or control pests. It should include a description of Canada's phytosanitary import requirements.
Plant protection specialist
A specialist with a well-established working knowledge of pest identification and control should be available to ensure that sanitation, pest monitoring and pest control measures are implemented as described in the manual.
Training of personnel
Personnel should be trained to detect pests, especially those regulated by Canada, and to follow a formal reporting system to communicate information on pest findings. Training should also include methods to handle material to reduce pest risk.
Examination of plants and plant products
Plants and plant products at the place of production / packing facility should be examined for the presence of specific pests on a regular schedule by designated personnel according to established methods, and corrective actions should be applied as necessary.
Packaging and transportation

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

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.

Records
Up-to-date records should be maintained and made available to the NPPO of the exporting country and to the CFIA upon request. The place of production's manual should clearly identify individuals responsible for maintaining various records, and the location and manner in which such records are maintained.

Responsibilities of the exporting country's NPPO

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.

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