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Improved Food Inspection Model
Final Model

2. Licensing

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Introduction

To support regulatory oversight activities, the CFIA requires information from regulated parties. The CFIA needs to know where regulated parties are located and what activities they are conducting in relation to food commodity preparation, distribution, and sale. Licences would allow the CFIA to authorize a regulated party to conduct a specific activity and, where relevant, allow the CFIA to attach specific conditions to these activities.

A single, non-transferable licence would be issued to the applicant to carry out his/her operations. The licence would describe all relevant activities the applicant is approved to conduct; additional licences may not be required for each activity or regulated commodity. A licence application may be made for each physical location, a number of physical locations, or by activity (for example, import, export), at the discretion of the applicant.Footnote 2

2.1 Parties subject to licensing

Regulated parties who are subject to the Acts and regulations administered and enforced by the CFIA would be required to have a licence if they

  • import or export food commodities, or
  • prepare food commodities for export or interprovincial trade.

The CFIA is considering whether to establish criteria for possessing a licence for some exporters (for example, those who prepare or export food to a foreign country that requires certification by a competent authority). Further consultation on licensing of exporters will be done as part of CFIA's food regulatory modernization initiative.

Not all operations involved in the preparation of food commodities would require a licence - some may not be subject to licensing. For example, operations not subject to licensing would include the following:

  • those that sell food only within the province (intraprovincialFootnote 3) but that must meet the requirements of the appropriate federal legislation (for example, the Food and Drugs Act)
  • transporters of food
  • any facilities that store food but that are not involved in importing, exporting or preparing food
  • retailers that are not involved in importing or exporting food but that must meet the requirements of the appropriate legislation (for example, the Food and Drugs Act)

Primary producers, such as field crop growers and commercial fishers, will not be covered by the proposed licensing regime. All primary producers are expected to comply with applicable Acts and regulations.

Operations not subject to licensing (for example, food businesses selling food commodities within a province) may choose to apply for a licence under the federal scheme. If a licence were to be issued, the licence holder would be subject to all applicable requirements of the federal legislation and the licensing regime.

2.2 Licensing requirements

An applicant for a licence must be located in Canada to enable the CFIA to carry out inspection activities and take compliance and enforcement actions as necessary.

As a condition of obtaining and maintaining a licence, applicants would be required to

  1. develop, implement, and maintain a written preventive control plan to meet food safety and other regulatory requirements;
  2. complete a licensing application; and
  3. pay the licence fee.

An applicant for a licence would be required to attest to having implemented a preventive control plan that is commensurate to the nature of his or her operations and meets the criteria set out in section 2.7.1 and annexe B, as applicable.

2.3 Period of validity

Licences issued under CAPA, MIA, FIA would continue during the transition to SFCA.

The CFIA is proposing a two-year licence period. Further consultation about licensing will be done as part of food regulatory modernization. A licence would be valid for the period indicated on the licence certificate. Licence holders may apply to renew their licence before it expires.

2.4 Issuing, renewing and amending a licence

The following subsections outline the approach that would be used for issuing, renewing and amending a licence. Additional information on the approach can be found in Annex A.

2.4.1 Issuing a licence

In order to obtain a licence, the applicant would be required to submit a licence application to the Minister (CFIA delegate of the Minister). A new licence would be required if the ownership of a food business (legally responsible party) were to change.

A pre-licensing inspection may be required for high-risk activities and would be a priority for first-time applicants. Notifications would be sent if a pre-licensing inspection is required.

2.4.2 Renewing a licence

A licence holder would be required to apply for renewal before the end of the licence's period of validity. A licence could not be renewed if there were any outstanding fees.

2.4.3 Amending a licence

A licence holder would be required to request an amendment to his or her licence when there is a change in his or her business profile or operations. The licence holder's preventive control plan would need to be updated to reflect any changes.

Amendments could also be made by the Minister (or delegate) with or without a request from the licence holder.

2.5 Suspension of a licence

Reasons to suspend a licence would include the following:

  • the licence holder had failed to comply with the conditions of the licence or with provisions of an Act or its regulations;
  • there are unpaid fees; or
  • there is a reason to believe that public health may be endangered if the operations were to continue.

Clearer distinction in criteria for suspending and cancelling licences.

The suspension would continue until the reason for the suspension was resolved or, if unresolved, until a decision to cancel the licence was rendered or the licence expired. The purpose of a licence suspension is primarily to protect consumers while allowing a licence holder to come into compliance. It may also be suspended for non-payment of fees.

If a licence were to expire while it is under suspension, it could not be renewed until the reason for suspension had been resolved.

2.6 Cancellation of a licence

A licence could be cancelled for reasons that include the following:

  • the licence was issued based on false or misleading information, or false or falsified documents submitted in or with the application;
  • the reason for suspension cannot be resolved within 90 days of the day the licence was suspended, though the licence holder could request an extension if necessary;
  • the licence holder continued to import, export or prepare a food commodity for export or interprovincial trade while the licence was under suspension.

A licence may also be cancelled at the request of the licence holder.

2.7 Preventive control plans

Globally, businesses/operations are also starting to require their suppliers to demonstrate that food safety oversight systems and approaches are effective. A preventive control plan is a systems-based approach that focusses on prevention as a way to achieve food safety and other regulatory compliance. Preventive control plans are recognized internationally as the best way to mitigate food safety risks and demonstrate that risks and hazards are controlled or eliminated.

As a condition of a licence, anyone who imports, exports or prepares food commodities destined for interprovincial trade or export is required to develop, document, implement, and maintain a preventive control planFootnote 4 suitable to his/her operations. Licence holders and other regulated parties are responsible for monitoring and controlling their operations, correcting any deviations as they occur, and maintaining ongoing compliance. This includes receiving, storage and transportation of incoming and outgoing ingredients or food commodities. The requirement for the preventive control plan and its content would be set out in regulations. Preventive control plans would not be required to be submitted with the licence application; however, they must be made available to the inspector on request.

The process of managing a preventive control plan would continually generate new information that could be used to actively improve operations in ways that maximize food safety and regulatory compliance. Management commitment is essential to the implementation and ongoing maintenance of an effective preventive control plan. Consistent communication is key to meeting food safety and other regulatory requirements. In addition, management must ensure that employees:

  • are trained;
  • are capable of performing the duties; and
  • are able to demonstrate an understanding of compliance.

Preventive control plan approach provides flexibility for consideration of a number of management systems.

The preventive control plan approach provides the regulated party with the flexibility to consider a number of process control or quality management type systems (for example, third-party assurance systems such as the Global Food Safety Initiative [GFSI], and the International Organization for Standardization [ISO]). The approach would accommodate most systems currently in use by industry. The proposed preventive control plan requirements are similar to Hazard Analysis and Critical Control Points (HACCP) systems, but differ in that the proposed plans must also address other regulatory requirements (for example, labelling, product quality, composition). Industries, including those currently operating under mandatory HACCP, would be able to transition to the new model with little or no adjustment.

To assist small industries in meeting this requirement, the CFIA is considering developing model systems and tools as available resources. The CFIA's Compliance Promotion Strategy is currently under development and will outline possible ways by which industry can seek guidance.

For those regulated parties who strive to adopt the best strategies, commercial or technological practices, his or her performance would be recognized by the CFIA through adjustments to oversight, as appropriate.

2.7.1 Elements of a preventive control plan

Depending on the nature of the operation, preventive control plans would include some or all of the following elements:

  1. process and product controls
  2. sanitation and pest control
  3. employee hygiene and training
  4. equipment design and maintenance
  5. physical structure and maintenance of the establishment
  6. receiving, transportation and storage
  7. traceability, recall and complaints

Performance criteria for traceability is included in Element 1: Processes and products, to support effective recalls.

The regulated party would be responsible for having a preventive control plan that uses principles of precaution to ensure his/her operation meets these outcomes and performance criteria - including ways to continually verify the effectiveness of the plan.

The preventive control plan would have to address the following:

a. Food safety hazards and controls

The plan would have to:

  • identify potential food safety hazardsFootnote 5 at any stage in an operation or in the food commodity, and specify control measures for these hazards;
  • identify the control measures that are to be validated, including any critical limits;
  • describe how the regulated party would validate that the control measures will achieve the critical limits and the outcomes before implementation; and
  • describe how the control measures would be re-validated whenever there is a change that may impact the process parameters.

b. Other regulatory requirements and controls

The preventive control plan would have to address other regulatory requirements for the food commodity and specify control measures for these requirements (for example, product composition, allergens, net quantity, quality [grade], label declarations).

c. Monitoring procedures

Monitoring confirms that all control measures are followed, and would include:

  • identifying an appropriately-trained responsible person;
  • identifying appropriate monitoring procedures;
  • establishing and following the monitoring frequency;
  • recording the monitoring results;
  • establishing procedures to follow when deviations occur, including isolation of potentially-affected commodities or production lots.

d. Verification procedures

Verification procedures confirm that monitoring procedures are followed and control measures are capable of consistently achieving the outcome, and would include:

  • identifying an appropriately-trained responsible person, other than the person who conducts the monitoring;
  • establishing the verification frequency;
  • recording the results of verification;
  • establishing procedures to follow when deviations occur;
  • where sampling and testing are used (of the environment or a commodity), the procedures would:
    • be described;
    • use techniques that do not contaminate the samples;
    • use accepted test methodologies that provide accurate and meaningful results.

e. Corrective actions

The preventive control plan would outline steps that would be taken following a deviation, and would include:

  • determining the root cause of the deviation, and preventing recurrence;
  • controlling the commodity by:
    • determining if the commodity is safe for consumption and suitable for use; and
    • bringing an affected commodity into compliance or disposing of it as appropriate; and
  • recording corrective actions taken.

f. Management review (review by the regulated party)

The regulated party would review the preventive control plan and its associated records to assess its ongoing effectiveness. The review would include:

  • identifying team members who will conduct the review;
  • establishing the review frequency (at least annual);
  • determining whether the preventive control plan has achieved the outcomes (including review of deviations and corrective actions);
  • identifying and implementing necessary changes for continuous improvement;
  • recording the results of the review.

g. RecordsFootnote 6

Records are evidence that the regulated party has implemented the preventive controls that are required by the conditions of the licence in order to meet regulatory requirements. Regulated parties would generate a number of different types of records, suitable to their operations, and these must be available for review during an inspection.

Where required by regulations, the preventive control plan would need to identify all records associated with each element of the preventive control plan and where and how long they would be retained, including, but not limited to:

  • validation of critical limits
  • monitoring (demonstrating control of a hazard or regulatory requirement; for example, shipping, purchase orders, training, equipment calibration and maintenance)
  • complaints and how they were resolved
  • deviations and corrective actions
  • verification
  • management review by regulated party
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