Improved Food Inspection Model
Revised Draft

2.0 Licensing

Introduction

To support regulatory oversight activities, the CFIA requires information from regulated parties. The CFIA needs to know where food businesses are located and what activities they are conducting in relation to food commodity preparation and sale. Licences would allow the CFIA to authorize a regulated party to conduct a specific activity and, where relevant, 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 would not be required for each activity or food 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.

2.1 Parties subject to licensing

Regulated parties who are subject to the Acts and regulations administered and enforced by the CFIA would be identified for licensing if they

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

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

  • those that sell food only within the province (intraprovincial2) but that must meet the requirements of the appropriate legislation (for example, the Food and Drugs Act)
  • transporters
  • 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)

Generally, primary producers, such as field crop growers and commercial fishers, would not be covered by the proposed licensing regime. However, in certain circumstances, primary production sites are the only effective mitigation point for food safety risks. The CFIA may require licensing of these primary producers. Any final decision from the CFIA in this regard would include a comprehensive policy review and consultation process.

Operations not subject to licensing 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 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. implement a written preventive control plan to meet food safety and other regulatory requirements,
  2. complete a licensing application, and
  3. pay the licence fee.

Preventive control plans must be made available to the CFIA upon request.

2.3 Period of validity

The CFIA is currently proposing a two year licence period.

The CFIA is currently proposing a two-year licence period. A licence would be valid for the period indicated on the licence certificate. Licence holders may apply to renew their licence upon expiry.

A listing of valid licence holders could be published on the CFIA external website.

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, including a draft licence application form, can be found in Annex A.

2.4.1 Issuing a licence

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

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

2.4.2 Renewing a licence

A licence holder would be permitted 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 penalties or fees.

2.4.3 Amending a licence

A licence holder would be required to request an amendment to their licence when there is a change in their 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 include the following:

  • the licence holder had committed deceptive practices to obtain the licence, such as providing false or misleading information to the CFIA;
  • the licence holder had failed to comply with the conditions of the licence or with regulatory requirements;
  • the licence holder had failed to address and/or correct regulatory non-compliance;
  • there are unpaid fees or administrative penalties;
  • the licence holder had obstructed or hindered a CFIA inspector from exercising their powers, or carrying out their duties or functions; or
  • public health would be endangered if the operations were to continue.

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.

2.6 Cancellation of a licence

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

  • the licence holder had committed deceptive practices to obtain the licence, such as providing false or misleading information to the CFIA;
  • the reason for the suspension cannot be resolved;
  • the licence holder continued to operate while his/her licence was suspended or
  • public health would be endangered if the operation were to continue.

2.7 Preventive control plans

Globally, retailers are also starting to require their suppliers to demonstrate that food safety oversight systems and approaches are effective. Preventive control plans are recognized internationally as the best way to mitigate and demonstrate that food safety 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 plan3 suitable to his/her operations. The requirement for the preventive control plan and its content would be set out in regulations.

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 assistance. Some sectors have already implemented preventive control systems to meet compliance (for example, voluntary Food Safety Enhancement Program, Quality Management Program). They would be able to transition to the new model with little or no adjustment.

A preventive control plan is a systems-based approach that focusses on prevention as a way to achieve food safety and other regulatory compliance. This approach would require licence holders to consistently monitor and control their operations, correct any deviations as they occur, and maintain ongoing compliance. 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.

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. processes and products
  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
The eighth element – company verification process – from the initial draft has been embedded in the management of preventive control plans.

The licence holder would be responsible for developing a preventive control plan that ensures 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 hazards at any stage in an operation or in the food commodity, and specify control measures for these hazards, including any critical limits;
  • describe how the licence holder 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
In preparing the revised draft model, the CFIA has refined the outcomes and measurable performance criteria (see Annex B) for each element of the preventive control plan.

The preventive control plan would have to identify 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 food safety and other control measures are followed, and would include

  • identifying an appropriately-trained responsible person(s)
  • establishing and following the monitoring frequency
  • recording the monitoring results
  • establishing procedures to follow when deviations occur, including isolation of potentially-affected food 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(s), other than the person(s) 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 food 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 food commodity by
    • determining if the food commodity is safe for consumption and suitable for use and
    • bringing an affected food commodity into compliance or disposing of it as appropriate; and
  • recording corrective actions taken.
f. Management review (review by the licence holder)

The licence holder 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
  • identifying and implementing necessary changes for continuous improvement
  • recording the results of the review
g. Records4

The preventive control plan would outline all records associated with each element of the preventive control plan and where and how long they would be retained, including

  • validation of critical limits
  • monitoring
  • deviations and corrective actions
  • verification
  • management review by licence holder

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