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Improved Food Inspection Model
Final Model

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Overview

Canada has one of the best food inspection systems in the world. However, in response to pressures from increased globalization in the food industry and advances in science and technology, the Canadian Food Inspection Agency (CFIA) is modernizing its approach to food inspection to maintain a robust approach to food safety and consumer protection. The move towards a more prevention focused and systems-based approach under the improved food inspection model enables both the CFIA and regulated parties to more readily adapt to emerging global and scientific trends. Canadians will continue to be protected by an effective food safety system that is both science- and risk-based.

This document describes the details of the CFIA's improved food inspection model and outlines the actions and activities the CFIA will undertake to verify compliance with federal food legislation in Canada.

All of the requirements, activities and actions described in this model were developed to promote the preparation, importation and exportation of safe and compliant food. Representatives from the CFIA's plant and animal programs provided input into the model's development. While the model is currently focused on food, the CFIA is moving forward to include these program areas as well with the objective of improving what is already one of the best inspection systems in the world. Animal and plant activities will continue to use the existing inspection approach until the model is fully aligned with their strategic outcomes.

The model represents the CFIA's vision and its approach to food inspection. The food inspection model is not a stand-alone initiative. For example, the CFIA is currently redesigning those business functions that are necessary to support the core components of the model, as they relate to Licensing, CFIA Oversight, Inspection, Compliance and Enforcement, and System Performance.

Figure 1 identifies which current CFIA functions, including both service delivery and core activities, would remain intact and which would change.

Beginning in the fall of 2013 and continuing through the year 2016, the CFIA will begin phasing the model into operation. More information about implementation, the phased-in approach and the transitional enforcement guidelines for the model and proposed food commodity regulations will be provided to stakeholders.

Guide for navigating the document

A key component of the model is the use of licensing as a tool to identify a regulated party and authorize him or her to conduct an activity. Section 2 and Annex A outline the conditions and processes around licensing.

A key requirement of the licensing regime is the condition that licence holders develop, implement and maintain effective preventive control plans suitable to the size and complexity of their operations. Section 2 and Annex B provide additional details on the proposed elements of the preventive control plan and the expected outcomes and performance criteria. CFIA inspectors would be guided by the inspection activities described in Annex B to assess how effectively a licence holder's preventive control plan demonstrates regulatory compliance with the expected outcomes.

Section 3 provides information about the risk-based inspection framework and the elements the CFIA would consider when determining the level of inspection oversight. The CFIA would prioritize inspections for those regulated parties for which the consequence of non-compliance would have a greater impact on public health.

Section 4 and Annex C provide an overview of inspection, including work planning, priorities and the general procedures inspectors would follow when conducting an on-site or follow-up inspection.

Section 5 and Section 6 cover the unique aspects associated with imported and exported food commodities. The licensing conditions proposed under the model - including the requirement to develop, implement and maintain a preventive control plan – would apply to some importers and exporters, and regulated parties who prepare food commodities for interprovincial trade. Importers and exporters may need to develop alternative strategies to address risk. Some examples of alternative strategies that could be used by importers are included in Annex B. Exporters would need strategies to meet the foreign country's regulatory requirements. In both cases, the Product and Process Control element of the preventive control plan would need to reflect controls appropriate to managing compliance with either Canada's import requirements or the export country's requirements.

Section 7 and Annex D are dedicated to a single, streamlined compliance and enforcement strategy across all food. Annex D provides an overview of the range of possible responses the CFIA may use to respond to an incident of non-compliance.

Section 8 and Annex E describes the CFIA's review mechanism, the complaint process, and the role of CFIA's Complaints and Appeals Office.

Section 9 outlines a system for continuous improvement, which focusses on consistency and quality of delivery, system design and overall system performance. As part of inspection modernization, the CFIA will to introduce a more systematic way of monitoring and evaluating overall effectiveness of the regulatory system.

Section 10 provides a general overview of how transparency would be achieved under the model. the CFIA is committed to providing the public with useful and timely information on its programs and services, regulatory requirements, and the outcomes of its enforcement actions and decisions.

Annex F provides an overview of the CFIA's initial thinking about exemptions. Further consultations on exemptions will be carried out as part of the CFIA's regulatory modernization initiative.

Annex G provides a glossary of terminology. It is designed to standardize language and support consistent interpretation of terminology used in the food inspection program.

Throughout the document, the call-out boxes containing explanatory text are used to signify changes in the model from the previous draft of the improved food inspection model.

1. Introduction

1.1 CFIA's legislative authorities

The CFIA plays a key role in maintaining Canada's food safety system. It has a mandate to administer and/or enforce food-related Acts and regulations.

The Food and Drugs Act (FDA) and regulations will continue to exist separately and continue to apply to all food sold in Canada. Health Canada is undertaking a separate, but coordinated modernization of its regulatory framework for food. The FDA will continue to protect consumers from any and all foods that are unsuitable for human consumption, including those marketed exclusively within provinces.

The Safe Food for Canadians Act (SFCA) received Royal Assent on November 22, 2012. It consolidates authorities and requirements set out in the Canada Agricultural Products Act (CAPA), the Fish Inspection Act (FIA), the Meat Inspection Act (MIA) and the food provisions of the Consumer Packaging and Labelling Act. When the SFCA comes into force, these Acts and their regulations will be repealed. The SFCA strengthens oversight of food commodities being traded inter-provincially or internationally. The SFCA does not change the inspection regime or the fines and penalties of the FDA and its regulations.

Strengthened oversight of imports under the proposed Imported Food Sector Product Regulations is expected to be in place before the food regulation comes into force. Strengthened oversight for imports is consistent with the overall direction of the improved food inspection model. Although the import regulations were conceived before the improved food inspection model, both share licensing and preventive control plan concepts. It should be noted, however, that these regulations, if promulgated, will be promulgated under the CAPA and will therefore be repealed when the SFCA comes into force.

Once the SFCA is in force, the CFIA will rely on the authorities in that Act and the FDA to carry out its mandate with respect to food safety. The SFCA and the model provide the foundation for a single, consolidated regulatory framework and the basis for a consistent approach to inspecting food. The food regulations are being designed to allow the Act to come into force and to support the new approach proposed by the model. In the interim, the existing legislation will remain in force.

1.2 Guiding principles

The CFIA's inspection modernization initiative will apply food safety management concepts that are globally recognized for how effectively they achieve the safety and suitability of food for human consumption and trade. These globally-recognized concepts build from the foundation of prevention. They include systems-based, performance-based and risk-based approaches that are

Canada is not alone in using a risk-based approach. Food inspection systems in the United States, Australia, New Zealand and other countries are also adopting risk-based approaches that compare risk across food commodities.

1.3 Roles and responsibilities

1.3.1 Regulated parties

Regulated parties are responsible for complying with the law. They demonstrate commitment to complying with the law by ensuring that food commodities and processes for which they are responsible meet regulatory requirements. Regulated parties also provide the CFIA with input and information that is used in regulatory decision making.

1.3.2 Roles and responsibilities of the CFIA

The CFIA verifies industry compliance through activities that include inspection, surveillance, sampling and testing. These activities are used to assess whether a licence holder has developed, documented, implemented and maintained written preventive control measures, whether these measures are effective, and whether regulatory requirements and licence conditions have been met. When non-compliance is identified, the CFIA takes appropriate compliance and enforcement action.

The CFIA derives its inspection authorities through Acts and regulations and is responsible for enforcing requirements in the Acts and regulations. In light of modernization, the CFIA will replace the existing commodity-specific inspection manuals with a new suite of materials for inspection staff. These materials will clearly link the regulations to their policy intent and provide functional direction to inspection staff on what should be verified (regulatory requirements) to assess that regulated parties are respecting the regulations.

The Canadian Food Inspection Agency Act, subsection 11(3), establishes that the CFIA is responsible for enforcement and administration of the provisions of the FDA as it relates to food, as defined in section 2 of that Act (except those provisions that relate to public health, safety or nutrition).

Currently, the CFIA is responsible for enforcing the CAPA, the FIA and the MIA - which are trade and commerce statutes applicable to certain food commodities - and for verifying compliance with the food-related provisions of the FDA. The CFIA has regulatory oversight and responsibility for interprovincial and internationally-traded food commodities and shares responsibility for the safety of intraprovincially-traded food commodities with provinces and territories. The CFIA will continue to inspect food establishments that prepare food for sale within provincial borders to verify compliance with the requirements of the FDA and its regulations using a risk-based approach. The division of powers and responsibilities between the federal and provincial jurisdictions will not change.

Recognizing that a range of barriers can impede compliance, regulatory organizations worldwide are introducing a more proactive approach to generating compliance from regulated parties. A crucial step will be to promote awareness and understanding of the requirements. New programming will require that guidance be provided to regulated parties to help them understand and comply with requirements. Compliance education documents will be prepared specifically for regulated parties and will describe regulatory requirements.

Compliance promotion is any activity that increases awareness, informs, motivates, or changes behaviour and encourages compliance with a regulatory requirement.

1.3.3 Key partners

Under the FDA, Health Canada is responsible for establishing requirements relating to the safety and nutritional quality of food sold in this country. Health Canada will continue to establish policies, regulations and standards related to the safety and nutritional quality of food. It will also conduct health risk assessments to inform Canadians and protect them from the health risks associated with food. The CFIA will continue to use these risk assessments to inform inspection activities and actions or decisions related to compliance.

Overall, the roles and responsibilities of key partners would not change significantly once the improved food inspection model is implemented. See Figure 2.

The Canada Border Services Agency (CBSA) will continue to clear shipments into Canada with the assistance of the CFIA, but will now also confirm that importers have a valid licence. The CFIA's electronic certification processes would be integrated as they are developed. Import related information, including licence numbers, will be captured in electronic transactions exchanged between the CFIA and the CBSA. CBSA officers are designated as inspectors to enforce "programme legislation", includingCFIA legislation. The CFIA will continue to work closely with the CBSA to verify that its officers have the necessary tools to enforce the CFIA's legislation at airports and other Canadian border points.

The Public Health Agency of Canada, the CFIA, and Health Canada will continue to work with public health officials and provincial ministries of health to confirm the source of food-related illnesses when an outbreak is suspected. Together, they provide reference laboratory services, conduct food safety investigations and take recall actions.

Figure 2: The roles and responsibilities of all partners
International Provincial/municipal agencies Federal partners CFIA Industry Consumers
Global food supply

Market and trade

Comparability and acceptance of food systems

Meet import requirements, provide export requirements

Enforce food safety laws within their jurisdiction

Inspection, public health and food safety surveillance

Lead public health surveillance and outbreak investigations

Develop health policies and standards and conduct health risk assessments

Delivers federal food inspection programs

Investigates foods linked to illness outbreaks

Initiates food recalls

Responsible for the production of safe food in compliance with government standards Responsible for safe food handling and preparation

2. Licensing

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

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:

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:

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:

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:

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:

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:

d. Verification procedures

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

e. Corrective actions

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

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:

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:

3. Risk-based oversight

Introduction

The CFIA, like other similar regulatory agencies in the world, uses scientific knowledge and risk analysis to inform its oversight and inspection activities. It is well understood that different food commodities and different preparation or processing approaches pose different risks.

Risk is generally determined by the scientific process of risk assessment in line with the Codex Alimentarius Working Principles for risk analysis. This process considers the following:

Food commodity risks posed by biological, chemical and physical hazards must be managed or eliminated during food production, processing, importing and distribution. It is the responsibility of regulated parties to produce safe food and mitigate food safety risks associated and demonstrate a commitment to a food safety culture within their operations by preventing, eliminating or reducing the risk to an acceptable level either through processing controls (for example, heat treatment) or through cross- contamination controls (for example, sanitation and hygiene).

The CFIA uses various information sources (for example, environmental scanning information, Codex Alimentarius standards, effectiveness of preventive control plans as demonstrated through inspection data and compliance data) and has implemented a number of monitoring and surveillance programs to expand the mapping of food-hazard combinations. This type of information, along with risk assessment, assists the CFIA in informing its approach for risk management, part of which is risk-based oversight.

Currently, the programs for the different food commodities are using somewhat different risk management approaches. The current risk management approaches are not accessible and are each structured differently.

In some cases, inspection activities and oversight are also affected by international requirements. Based on foreign country requirements, some regulated parties are subject to specific oversight requirements for eligibility to export to certain countries. Generally, these considerations flow from some countries having different standards for commodities. Similarly, Canada establishes requirements for imported food commodities. For example, to be considered to meet Canada's requirements, imported dairy products must be manufactured from sound raw materials, prepared under sanitary conditions, and, at the time of shipment to Canada, must be sound and fit for human consumption. Canada's regulatory requirements for food specify a consistent expectation for safety of all food commodities.

The CFIA takes the information related to risk and national and international standards (such as those developed by Health Canada or the Codex Alimentarius Commission), as well as international obligations into consideration as it organizes its inspection activities. Consequently, under the current food inspection system, establishments preparing or handling high risk commodities, such as ready-to-eat meat have inspectors present daily, while establishments preparing lower risk commodities, such as dry pasta and honey products, are inspected only periodically.

3.1 Risk-based oversight in the model

The CFIA has always used a risk-based approach for its inspection activities. As part of its modernization efforts, the CFIA will take a more structured and transparent approach to allocating resources without compromising food safety. The CFIA has developed a framework to provide a standard and consistent approach to improve its oversight activities (inspection, audits, directed sampling and testing, surveillance, etc.) on a risk basis.

The CFIA will:

  1. Take a more structured approach to analysing risks related to different food commodities by:
    1. updating food commodity risk information on a regular basis to take into consideration any developments in science, experiences in Canada or other countries, or new information;
    2. making the risk information more accessible and transparent; and
    3. applying this approach across all food commodities; and,
  2. Add a common systematic approach to assessing the preventive control plansFootnote 7 and the track record of regulated parties (including associated surveillance and recall data, certification to a private food safety standard that is recognized by the CFIA, and the regulated party's compliance history) to determine if inspection activities need to be adjusted. For example, once a regulated party has established a compliance history, the intensity of inspection and/or methods of inspection may be adjusted to correspond with how effectively the regulated party has prepared safe and compliant food.

The CFIA would rank food-hazard combinations from high to low in how likely they are to pose a public health impact.

On a predetermined basis, the CFIA would review the food commodity risks and regulated party track record history to confirm and/or update its information. Based on the information, the CFIA would then determine the frequency, intensity and type of oversight activities required and allocate its resources to those areas and regulated parties that represent the highest risk to public health. The CFIA would also continue to take into account any specific requirements of other countries to facilitate access to export markets.

In addition to the risk factors and the international obligations to maintain access to export markets, there are a number of triggers that could impact onCFIA oversight activities as elements of a risk management strategy. These include:

3.2 How does a risk-based approach work?

This systematic and structured risk-based approach would help the CFIA enhance its determination of:

Figure 3 illustrates the factors and criteria CFIA considers using to conduct a food commodity risk analysis and the assessment of regulated parties to determine the frequency, intensity and type of its oversight activities.

Figure 3: Factors in determining frequency, intensity and type of oversight activities
Figure 3: Factors in determining frequency, intensity, and type of oversight activities. Description follows.
Description for graph: Factors in determining frequency, intensity and type of oversight activities

Figure 3 illustrates the factors and criteria that the CFIA considers when conducting a food commodity risk analysis and the assessment of regulated parties in order to determine the frequency, intensity and type of Agency oversight activities.

The graph flows from top to bottom starting with

  • the types of science-based information, with an arrow pointing to
  • the determination of the food commodity risk, with an arrow pointing to
  • examples of criteria to be considered, with an arrow pointing to
  • frequency, intensity and type of oversight activities (inspection , audits, sampling, surveillance, etc.)

The market access requirements would also need to be considered after the determination of the food commodity risk, but prior to determining frequency, intensity and type of oversight activities.

The types of science-based information include

  • environmental scan information, monitoring and surveillance data,
  • risk assessments, Codex Alimentarius standards,
  • biological, chemical and physical hazards reasonably likely to occur in food commodities, and
  • knowledge of how the process, system or innovative interventions used to prepare food contribute to or reduce or eliminate risks.

Examples of criteria to be considered for the determination of the food commodity risk are

  • the food commodity type (e.g., ready-to-eat, not ready-to-eat),
  • the potential for acute illness to occur if hazards not controlled,
  • volume of production, consumer target groups,
  • track records (compliance history, recalls, enforcement data, etc.),
  • preventive Control Plan (PCP), and
  • other Risk Management intelligence.

These would then lead, along with the consideration of market access requirements, to the frequency, intensity and type of oversight activities.

From a risk analysis perspective, the CFIA would group food commodities and preparation processes with similar levels of risk and determine a level of oversight to each grouping. For example, regulated parties who prepare ready-to-eat foods for interprovincial or export trade, or who import them (for example, cheese and chopped salads) that support the growth of pathogens like salmonella (biological hazards) may be subject to a different level of oversight than regulated parties who prepare or import ready-to-eat foods that are shelf-stable (for example, honey products and bakery products) and do not support the growth of pathogens.

A number of criteria pertaining to individual regulated parties are then considered jointly with the food commodity risk to determine the level of oversight activities applied to that regulated party. These criteria include, for example, volume of production, consumer target groups, preventive control plans, and the track record of the regulated party as it respects compliance with food safety and other regulatory requirements. Any inspection activities required to support export market access would also have to be considered in the determination of the level of oversight. Using the enhanced approach, if a trend in non-compliance were observed at a specific regulated party's operation, the CFIA could:

Following the principles outlined on risk based oversight in this section, the frequency, intensity or type of CFIA oversight activities may also be adjusted where:

Other food inspection systems around the world, such as those implemented in the United States, Australia, and New Zealand are also adopting risk-based approaches that compare risk across food commodities. Food science knowledge and tools available for analysing the risks associated with food are constantly evolving. Canada is committed to using the most modern tools and systems available for risk management and delivery of its inspection activities.

4. Overview of inspection

Introduction

The purpose of the CFIA's inspection process is to assess whether a regulated party has developed, documented, implemented and maintained written preventive control measures, whether these measures are effective, and whether regulatory requirements and licence conditions have been met.

Inspection activities related to a preventive control plan would be organized by the seven elements of the preventive control plan. Inspectors would use a combination of traditional inspection (where the focus is on the end-product and processing environment) and audit techniques (such as record review, interviews, and observation) for assessing compliance and evaluating the impact of non-compliance.

4.1 Inspection work planning and priorities

The CFIA's inspection activities are determined from a national work plan. As a government agency, the CFIA is accountable to the public for using resources effectively and efficiently.

Work plans indicate the number of inspectors the CFIA has and the amount and type of inspection activities they will perform each fiscal year. The various CFIA District Offices across Canada use the national work plan as a basis of their individual office work plans.

As the national work plan is developed, inspection priorities would be based on risk and compliance data and could consider:

There are a number of situations that could cause CFIA to initiate an inspection that is not part of the work plan. These include:

The work plan could include targeted inspection or surveillance activities, if the CFIA observes a trend in non-compliance. For technical non-compliances, a targeted inspection response might be developed–which could include further clarification of the requirements or policy to support improving compliance levels–followed by a compliance and enforcement strategy.

Added clarity on control over non-compliant product and regulated party's duty to notify

When notified by a regulated party of non-compliant product, the CFIA would take steps appropriate to the nature and severity of the issue to prevent further product distribution, until corrective action had been taken at the source.

The regulated party would also be required to submit evidence of compliance before the CFIA would give permission to resume distribution of the food commodity.

4.2 Inspection procedures

Inspection procedures provide a systematic way to approach inspections. Inspection activities could include making visual observations, evaluating records, interviewing personnel, sampling and testing.

The procedures would provide inspectors with the flexibility to adapt to different situations that may arise during an inspection; the inspector would be able to assess the potential impact of non-compliance to determine whether and what further actions are required.

There are four basic steps to inspection:

There are four basic steps to inspection

Description for four basic steps to inspection
  • Step 1: Prepare for the Inspection, with an arrow pointing to
  • Step 2: Conduct the Inspection, with an arrow pointing to
  • Step 3: Communicate the inspection results, with an arrow pointing to
  • Step 4: Conduct a follow-up inspection

Step 1: Preparing for an inspection

Preparation for an inspection would include determining a preliminary scope. Scope can be based on the national work plan but may be adjusted for a variety of reasons (for example, changes in activity, compliance history). Preparation would also include determining whether an inspection would be announced or unannounced, reviewing the applicable Acts, regulations and other reference materials, and finally, gathering all tools, equipment and supplies needed.

Step 2: Conducting an inspection

During an inspection, all findings would be recorded, including any discussions. Additional objective evidence, such as physical samples, photographs,Footnote 8 and copies of documents or records would also be collected. The process of conducting inspections would include the following activities:

  1. Opening meeting: An opening meeting would introduce all CFIA staff and outline the scope of the inspection. It would provide the regulated party with the opportunity to confirm any changes to his or her company profile and preventive control plan (since last inspection). It would also provide the CFIA with an opportunity to update the regulated party on any changes to the inspection process and/or relevant regulations.
  2. Initial walk-through inspection: This part of the inspection would serve to identify areas that should also be added to the scope of the inspection or targeted for more intensive inspection.
  3. Confirmation of scope: Based on recorded observations from the initial walk-through inspection, the scope would be confirmed or amended accordingly.
  4. Completion of inspection: Conducting an inspection would include using traditional and audit techniques. Namely, visual inspection, record review, interviews, sampling, etc.
  5. Assigning a level of non-compliance: There are three levels of non-compliance that could be used, based on the impact on food safety:
    • critical: immediate impact on food safety or repeated serious non-compliance
    • serious: potential impact on food safety
    • technical: non-compliance with regulatory requirements that are not related to food safety
    The table below illustrates the difference between critical and serious non-compliance through the use of examples. It is not intended to be an exhaustive list.
    Type of non-compliance Examples
    Critical
    • Records show that a food commodity has been processed outside of critical limits (time, temperature or pressure deviations) with no corrective action taken.
    • Inspector observes cleaning and sanitizing operations generate spray that comes into direct contact with food commodity.
    Serious
    • Inspector observes condensation is dripping onto food contact surfaces, but no processing or preparation is taking place.
    • Records show that not all measuring instruments are calibrated.

    If serious or critical non-compliance were detected, a corrective action request would be issued, indicating which regulatory requirement(s) had not been met. Technical non-compliances would be recorded and corrected by the regulated party, but a corrective action request would not need to be issued. Technical non-compliances could be enforced by CFIA through graduated compliance actions, up to and including prosecution.

  6. Completion of inspection report: The inspection report would include the inspection findings, corrective action requests issued, technical non-compliance observed and actions taken.

Step 3: Communicating the inspection results

A closing meeting would be held with the regulated party to discuss the outcomes of the inspection, including any incidents of non-compliance and next steps. The inspection report would also be shared once completed.

Step 4: Conducting a follow-up inspection

A follow-up inspection would be conducted to confirm that the corrective action has been completed and is effective, and that any changes in the preventive control plan are documented.

For additional information on the basic inspection steps see Annex C.

For details on inspection activities in relation to the elements of the preventive control plan, see Annex B.

5. Imports

The licensing requirements proposed in the model apply to importers. Some example strategies can be found in Annex B sub-element 1.3 of Element 1: Import control outcome: Performance criteria.

5.1 Preventive control plans

Food products entering Canada must meet all regulatory requirements for safety, nutrition, composition, labelling, packaging and quality, as applicable. Importers do not have direct control over food production and would therefore need to develop other strategies to address risks, including having records to demonstrate how these strategies work.

Importers would need to include elements of the preventive control plan that apply to their operation (see Annex B). For example, importers without facilities would not be expected to address physical structure and maintenance. However, all importers would, at a minimum, need to include the following elements in their preventive control plans:

Importers who are involved in further handling or repackaging of food would need to address all seven elements of the preventive control plans.

5.2 Inspection

The inspection approach outlined in section 4.2 would be used to verify the effectiveness of the importer's preventive control plan.

When notified of a non-compliant food commodity, the CFIA would take steps appropriate to the nature and severity of the issue to prevent further product from entering the marketplace until corrective action had been taken. An inspector, who has reasonable grounds to believe that an imported food commodity does not comply with the legislation, may order that it be removed from Canada or, if removal is impossible, that it be destroyed. If not removed or destroyed, the commodity would be forfeited and may be disposed of as the Minister directs. If, however, the commodity does not present a risk to human health, the regulated party may be given an opportunity to bring it into compliance. In the case of critical and serious non-compliance, the CFIA would notify known importers of the affected product through an import alert and the competent authority in the exporting country.

Depending on the nature and severity of non-compliance, the CFIA might review technical arrangements or other bilateral agreements to determine whether amendments would be required.

The CFIA would use foreign country comparability and audits as well as product surveillance as tools to determine the level of compliance for products entering Canada.

5.3 Foreign country comparability

Canada is a net importer of food. Conducting a foreign country system audit is a means of assessing risk and determining whether a country's inspection system is equivalent or comparable to Canadian standards.

The CFIA would conduct foreign country audits according to the national treatment provisions of the World Trade Organization Agreement on Sanitary and Phytosanitary Measures.

Equivalence or comparability does not mean that the foreign country's system must be the same as Canada's food inspection system. Rather, it is based on the ability of an exporting country's system or sanitary measures to achieve the same outcome or provide for the same "appropriate level of protection" as Canada's system or sanitary measures.

Based on risk and available resources, the CFIA may choose to perform on-site foreign country system audits to review the food safety requirements that a foreign country imposes on its domestic manufacturers. The results of these audits would feed into the risk-based inspection oversight framework as part of the CFIA's risk intelligence gathering and analysis activities. The CFIA is developing its policy on comparability assessment of trading partners and will be carrying out consultations as appropriate.

5.4 Surveillance

Surveillance of imported food is a key activity when:

The CFIA would use product surveillance as a tool to identify gaps and trends, to determine sector performance, or to provide baseline information such as the level of chemical contaminants in certain foods. Analysis of this type of information would provide a mechanism for continuous improvement including adjusting the risk-based inspection oversight framework, changing standards or requirements, and planning work.

6. Exports

The licensing requirements proposed under the model apply to exporters.Footnote 9 See Annex B sub-element 1.4 of Element 1: Export control outcome: Performance criteria.

6.1 Preventive control plans

Food products exported from Canada must meet all of the importing country's requirements. An exporter's preventive control plan would require export controls to address any foreign regulatory requirements (for example, labelling requirements).

6.2 Inspection

The inspection approach in section 4.2 would be used to verify the effectiveness of the exporter's preventive control plan.

6.3 Issuance of export certificates

The model proposes that export certificates be issued based on the exporter's compliance with his or her export controls, and that they could be issued without further lot-by-lot product inspection. Clearly, this approach would only be used if it were accepted by the importing country. The CFIA would continue to negotiate with its trading partners to promote this concept. If required by the foreign country, the CFIA could conduct food commodity inspection of lots to be exported.

If notified by an exporter that a non-compliant food commodity had been exported, the CFIA would take appropriate steps to monitor the recovery and control of the non-compliant food commodity. Trading partners would be alerted to this non-compliance using established protocols. The exporter would have to adjust his or her preventive controls to address this non-compliance.

7. Compliance and enforcement

Introduction

The model proposes to apply a single, consistent compliance and enforcement strategy across all food commodities. This strategy would be based on the principle that industry is responsible for producing safe food that complies with regulatory requirements. When non-compliance is found, industry would be responsible for taking appropriate action to correct the situation. The model aims to make compliance and enforcement transparent and appropriate to the level of non-compliance.

Compliance promotion complements rather than diminishes the CFIA's ability to take enforcement action, when necessary.

The processes that lead to inspection decisions–or compliance and enforcement actions–must be objective, impartial and equitable. They must be in keeping with the CFIA's values and ethics and respect the regulated party's rights.

For more information, see the Compliance and Enforcement Operational Policy.

As the food regulatory framework is modernized, this policy will be reviewed and updated, as required.

7.1 CFIA response when non-compliance is detected

The inspector would respond to non-compliance. Specific responses could be directed at the food commodity (for example, seizure and detention of product) and/or the regulated party (for example, issue a corrective action request). The inspector would have the flexibility to select the appropriate response based on the gravity of the non-compliance, considering factors such as the potential or actual harm to public health, the compliance history of the regulated party and the intent.

The appropriate level, type and extent of response would depend on a range of factors, including:

When dealing with imports, the CFIA might require importers to provide documentation or information to demonstrate that the food commodity is compliant with the legislation. An importer who has a history of importing non-compliant food commodities may be required to submit evidence of compliance before the CFIA would give permission to import a food commodity. For example, an importer could be required to provide the CFIA with documentation from an accredited laboratory or other documented evidence of analytical results demonstrating compliance for five consecutive shipments following the non-compliant importation.

7.2 Compliance and enforcement actions

The CFIA recognizes that, for many regulated parties, the transition to the improved food inspection model would require time to

Technical and educational outreach will be performed as part of the CFIA's Compliance Promotion Strategy

The CFIA recognizes that many regulated parties' business models would need to evolve. As part of its compliance promotion strategy, the CFIA intends to provide technical and educational outreach in a variety of formats. The intention is to make it easy for regulated parties to gather information and interact with the CFIA online and in person (for example, an online labelling tool, generic model systems). Transitional enforcement guidelines would also be used in the initial stages of implementing the model and proposed food regulations.

If there is critical or serious non-compliance, the affected food commodity would be controlled and the non-compliance would be addressed to prevent recurrence. At the end of the transition period, the CFIA would use its single compliance and enforcement strategy to respond to the non-compliance and would take action by using any of the tools found in Annex D.

Administrative Monetary Penalties (AMPs), enabled by the Agriculture and Agri-Food Administrative Monetary Penalties (AAAMP) Act are an important element of a modern enforcement and inspection regime and offer specific benefits.

Under the SFCA, the CFIA will have the authority to adopt AMPs as an enforcement tool for food commodities.

8. Review mechanism

The CFIA made a commitment to implement an internal review mechanism to address issues that are raised by regulated parties and others. A Complaints and Appeals Office (CAO) has been established already for regulated parties, stakeholders and members of the public to register complaints related to quality of service, administrative errors and certain other types of decisions with which they disagree.

The SFCA, when fully in force, will amend the Canadian Food Inspection Agency Act to permit the Minister to designate review officers who will conduct reviews of certain decisions made under the authority of an Act that the CFIA enforces and/or administers. Currently, there is no specific authority in the SFCA for a review officer to modify a decision made by an inspector or other CFIA official in the course of carrying out his or her responsibilities under legislation enforced by the Agency. The ability of a review officer to verify, cancel or confirm prescribed decisions will require regulations to be made setting out the parameters of the process before the authority may be exercised. Without this authority, the COA's role in relation to complaints respecting decisions is limited to making recommendations.

For more information on the existing CFIA Review Mechanism, see Annex E.

9. System performance and continuous improvement

Introduction

As part of inspection modernization, the CFIA is also modernizing its approach to performance measurement. This new approach recognizes the scope and complexity of the CFIA's role in food safety. It also recognizes that there are many other participants in the food safety system who influence the ultimate outcome of protecting Canadians from preventable health risks.

Added clarity on:

  • the CFIA's approach to measuring system performance
  • how performance measurement result would be used to support continuous improvement

The CFIA is introducing a more holistic way of monitoring and evaluating the overall effectiveness of the food safety system. The new approach would determine whether the system, as a whole, is achieving the desired outcomes. It would align with the CFIA's modernized approach to outcome-based regulations.

The CFIA will improve the measures being used to evaluate how well its inspection activities, business processes and services contribute to the desired outcomes. The CFIA will also look at how it engages and influences the various participants in the food safety system and how the participants work together to prevent, mitigate and manage the risks to the food safety system.

Establishing key desired outcomes for the system as a whole and measuring performance against them will allow the CFIA, regulated parties and other participants in the food safety system to use the results to adapt, improve and become more effective at managing risks to food safety.

The objectives of the performance measurement system are to assess:

To identify:

The CFIA may also use the results of the performance assessment for:

9.1 Systems performance framework

To build its approach to measuring system performance, the CFIA developed a systems results model (see Figure 4) that outlines:

The results model depicts three levels of assessment that are required to ensure that system performance objectives are met. Based on the information obtained at each level, a comprehensive analysis would be conducted and system improvements would be scheduled and implemented as required, with higher-priority improvements taking precedence.

To help embed continuous improvement in its philosophy, the CFIA is establishing inspection system verifiers to oversee the performance of Canada's entire food inspection system. The inspection system verifiers would conduct in-depth reviews of food safety plans in regulated party's operations to, among other activities:

Monitoring and evaluating performance is a CFIA responsibility. To be useful, the number of measures that are tracked and reported by the CFIA need to be limited, highly relevant and exception-based where possible. The CFIA would develop the key performance indicators and targets to check whether policies, procedures and practices that are critical for food safety successfully achieve the desired results. The expectation is that the development of performance information would be iterative and would mature over time.

The three levels of assessment are as follows:

Level 1: CFIA activities and actions are risk-based, consistent, efficient, relevant and professionally conducted

a. Appropriateness of program design

Objective: To assess that the program is designed in a risk-based and proactive manner to meet food safety and regulatory objectives. For example:

b. Consistency and quality of service delivery

Objective: To measure the consistency and quality of the delivery of the inspection program. For example:

Level 2: Regulatory system stakeholders engage, comply and act in support of the system outcomes

Objective: To assess the extent to which key stakeholders engage, cooperate, and accept and act on their responsibility to prevent and mitigate risks. For example:

Level 3: Achievement of strategic outcomes is transparent

Objective: To assess the extent to which the CFIA has achieved its mission in relation to a safe and accessible food supply and minimizing the risks to food. For example:

Figure 4: Systems Results Model

Click on image for larger view

Figure 4: Systems Results Model. Description follows.
Description for Figure 4: Systems Results Model

Figure 4 illustrates three levels of assessment that the CFIA would use to measure the performance of Canada's food safety system.

At the bottom, the first level of system performance (Level 1) identifies activities over which the CFIA has direct operational control such as program delivery and inspection. Level 1 activities are risk-based, consistent, relevant and professionally conducted.

On top of level 1, the second level (Level 2) identifies stakeholders over which the CFIA has direct influence with the intermediate outcomes or actions and immediate outcomes or awareness, including

  • governing, regulatory bodies and support
  • industry representatives and associations, and
  • Canadians

The figure has arrows pointing to and from each stakeholder group in Level 2, demonstrating the complex relationships they all share. The figure also has arrows pointing up and down from Levels 1 and 2, demonstrating the many CFIA inputs that affect the actions and awareness of stakeholders, as well as the effect of the decisions by these same stakeholders on the CFIA's activities.

On top of level 2, the third level (Level 3) identifies a macro, strategic outcome, namely a safe and accessible food supply where risks to food are minimized. The CFIA has indirect influence over this outcome.

The figure has arrows pointing from each of the stakeholder groups in Level 2 up to Level 3, demonstrating the roles and impact that all stakeholders have on a safe food supply.

9.2 Performance assessment

Developing an innovative and modern approach to assessing system performance against desired outcomes is central to the CFIA's overall modernization agenda. It will be key to promoting continuous learning and improvement across the regulatory system, while also supporting effective accountability.

Several sources of data will need to be incorporated into the assessment process to reflect the complex food safety system, the numerous players involved and the wide scope of CFIA responsibilities. Assessments would be focused both internallyFootnote 10 and externallyFootnote 11 and be either continuous or periodic. Assessment results would be used for:

The following are examples of performance assessment tools that are currently available.

a. Field observations: Assess internal performance to identify gaps and issues in:

b. Quality management: Assess internal performance by tracking compliance with internal protocols, service standards and expectations.

c. Audit: As per the Treasury Board Policy on Internal Audit, conduct periodic internal audits of the governance, risk management and controls that are in place for effective management practices and accountability.

d. Evaluation: As per the Treasury Board Policy on Evaluation, conduct internal evaluations of the relevance and performance of programs, initiatives and policies.

e. Surveys: Assess internal and external performance by seeking input from CFIA staff, regulated parties and other system stakeholders on:

10. Transparency

The safety of food is important to all concerned, from producers to consumers; in fact, many players are responsible for contributing to food safety. Consumers' confidence in the safety and quality of their food supply depends in part on their perception of the effectiveness of food inspection system.

The consequences of consuming unsafe food can be significant and, if an organization is not sufficiently transparent and responsible, there is a lack of accountability, trust is damaged, and credibility is at risk. For these reasons, it is important that the CFIA operates as a more transparent organization by involving all those who have a stake in safe food.

One of the principle outputs from the CFIA's transparency initiative is to provide information to consumers that will enable them to make informed buying decisions. However, the value of transparency is more far-reaching in terms of the impact that it can have on influencing behaviours that promote compliance and mitigate risk. The potential value of transparency initiatives is realized when:

From an outcomes perspective, the CFIA envisions that improvements in transparency will help increase the public's understanding of the public health impact of the CFIA's activities and will promote confidence in the safety and quality of Canada's food supply.

The CFIA is committed to providing the public with useful and timely information about its programs and services, regulatory requirements, and the outcomes of its enforcement actions and decisions. In meeting this commitment, the CFIA is publishing information on its compliance and enforcement activities on its website. The information includes:

Other transparency initiatives include:

  1. Service delivery

    The CFIA has released a Statement of Rights and Services that provides stakeholders with information on their rights and what they can expect from their interactions with the CFIA. Six accompanying "guides to inspection" (for consumers, producers, processors, animal transporters, importers and exporters) have also been prepared and are available on the CFIA's website.

  2. Complaints and reviews

    The CFIA's complaints mechanism provides stakeholders with a more transparent and accessible way to register complaints and request reviews. Data from this initiative can help to improve information distributed to regulated parties.

  3. Information sharing

    The CFIA is examining opportunities for making the results of inspections, licence cancellations and licence suspensions available to the public to enable consumers to make informed buying choices.

In examining approaches used by other nations with strong food safety systems, the CFIA has observed that governments that are accountable for delivering on food safety are moving to:

The CFIA is committed to making more science information and data available to Canadians as a way of demonstrating:

Annex A: Details for issuing, renewing and amending a licence

The following provides additional information on the approach for licensing. More detailed procedures will be developed and finalized in conjunction with the food regulations.

Below is an example of the type of information the CFIA expects to request from regulated parties to support risk management.

Applying for / obtaining a licence

Applicants for a licence would submit the following information to the CFIA

  1. Application status (applicant would check one that applies)
    • new
    • amendment
    • renewal
  2. Business activities information (applicants would check all that apply)
    • operations importing food with storage / distribution facilities
    • operations importing food without storage / distribution facilities
    • operations exporting food with storage / distribution facilities
    • operations exporting food without storage / distribution facilities
    • operations preparing food for interprovincial trade
    • operations preparing food for export
    • operations not falling within one of the above categories, specify
  3. Contact and legal information (all fields must be completed)
    • business name and operating name
      • copies of the applicant's articles of incorporation or provincial registration, if any
    • legal (civic) address (physical location) in Canada
      • all physical location(s) covered under the licence in Canada
    • mailing address (if different from legal address)
    • address where records will be available (if different from legal address)
    • fax/telephone number, email address
    • name of operator (licence holder)
    • name of primary contact person at each physical location
    • name of emergency contact
  4. Business status (applicants would check one that applies)
    • active
    • inactive
    • seasonal

    Note: If an applicant's business is a seasonal operation, then he or she would be required to notify the CFIA of the planned start and end date for operations.

  5. Hours and days of operation for each establishment
    • applicant would enter the hours of operation
    • applicant would enter days of operation
  6. Commodity information for each establishment covered by the licence (applicants would check all that apply)
    • alcoholic beverages
    • non-alcoholic beverages
    • confectionery, sweeteners, snack foods (containing or not containing nuts), desserts
    • dairy
    • egg and egg products
    • fats and oils
    • fish and seafood products (including bivalve molluscs)
    • food chemicals (for example, additives, processing aids)
    • fresh fruit
    • fresh vegetables
    • grain-derived foods (for example, breakfast cereal, bread and bakery, pasta)
    • honey and honey products
    • infant foods
    • maple products
    • meat and poultry
    • multiple/mixed foods (for example, pizza, frozen meals, sandwiches)
    • nuts, grains, seeds
    • processed fruit products
    • processed vegetables
    • spices, herbs, flavours, condiments, dressings
    • other (please specify)
  7. Business size
    • number of employees working in each establishment (ranges to be provided as options–applicants would check one that applies)
    • estimates of annual volume of production or importation or exportation of food commodities (ranges to be provided as options–applicants would check one that applies)
  8. Commodity type, handling information and volumes (applicants would check all that apply)
    • ready-to-eat:
      • pathogen reduction step
      • control of contamination
      • are in a form that is edible without additional preparation to achieve food safety
    • not ready-to-eat
    • importation:
      • prepackaged foods only
      • foods for packaging, labelling, re-labelling, further processing
    • number of different types of food commodity (ranges to be provided as options–applicants would check one that applies)
    • estimated annual volume of production, importation or distribution (ranges to be provided as options–applicants would check one that applies)
    • consumer target audience

Amendments and renewals

For amendments and renewals, the licence holder would access his/her unique account in the CFIA web portal; select the activity he/she needs (for example, renewal, amendment); modify the information in the application form, as applicable; pay the required fee, if any and submit.

Process for issuing a licence

Step 1: Application review

  1. Upon receipt of the licence application, the Minister (or delegate) would review it and, if an issue were identified, document the relevant facts.

    The Minister (or delegate) could refuse to issue a licence if the applicant

    • does not meet conditions of licensing
    • has submitted inaccurate information
    • has provided false or misleading information, documents or records
    • engaged in deceptive practices in order to obtain a licence
  2. The Minister (or delegate) would review the facts before rendering a decision. If required, expert advice would be sought to ensure that the licensing criteria were applied consistently.
    • A pre-licensing inspection may be required for high-risk activities and would be a priority for first-time applicants.

Step 2: Communication of decision

  1. Notifications would be sent if a pre-licensing inspection were required.
  2. If a licence were to be refused, a written notice of refusal would be sent, with the reasons for the refusal.
  3. The applicant could request a review of the refusal and present facts to support the request.

Step 3: Decision review

The CFIA is currently considering options for a review mechanism that would be made available to regulated parties following a decision to refuse to issue a licence.

Process for suspending a licence

Step 1: Initiation

  1. The inspector would identify any non-compliance(s) and gather facts to support the finding(s).
  2. The inspector would inform his or her management of the facts of the non-compliance.
  3. The licence holder would receive a report of the inspection and would be provided an opportunity to remedy the non-compliance.Footnote 12

Step 2: Consideration of the inspection findings

  1. If the non-compliance were not addressed, the licence could be suspended. The delegate of the Minister would review the inspection findings and possibly seek expert advice, as appropriate, to ensure that the suspension criteria were being applied consistently.Footnote 13
  2. The delegate of the Minister would render a decision.

Step 3: Communication of decision

  1. If the licence were to be suspended, the licence holder would receive a written notice of the decision, and the reasons for the decision.

Step 4: Lifting of a suspension

  1. The licence holder would submit a written plan to address the issues that resulted in suspension of the licence.
  2. The inspector would follow up to determine whether the issues indicated in the suspension were addressed.
  3. If the issues were addressed, the inspector would report his or her findings and close the file. Additional conditions could be imposed on the licence by the Minister.
  4. If the issues were not resolved, the process would move to that described below (Process for cancelling a licence).

Process for cancelling a licence

Step 1: Initiation

  1. If the inspector were to identify unresolved issues as per section 2.6 (Cancellation of a licence), the cancellation process would be initiated.

Step 2: Evaluation

  1. The Minister (or delegate) would review the inspector's recommendation and the Agency's file to verify that the cancellation criteria were being applied consistently.
  2. A licence holder is entitled to know the case against him or her and may request an opportunity to be heard and to respond to the arguments and evidence presented to the Minister (or delegate) against him or her. A licence holder must request a review of the decision within the time limit specified in the written notification.
  3. The hearing may be oral or by way of written submissions.
  4. The Minister (or delegate) would consider the submissions of the inspector and the licence holder and render his or her decision with reasons for the decision.

Step 3: Communication of decision

  1. The licence holder would receive written notification of the decision. If the licence were to be cancelled, this would include the reasons for the decision to cancel the licence.

Annex B: Elements of the preventive control plan: outcomes, performance criteria and inspection activities

Each element of a preventive control plan has associated outcomes and performance criteria. A regulated party would address the criteria to support achieving the outcome.

Following the performance criteria listed below for each element, are related lists of inspection activities that inspectors could use to assess compliance.

Element 1: Product and process controls: Outcomes and performance criteria

Expected Outcomes

  1. Product and process controls contribute to the production of safe and compliant food.
    • 1.1 Process control outcome
      • The process is controlled to achieve food safety and other regulatory compliance.
    • 1.2 Product control outcome
      • Finished products meet regulatory requirements and are appropriately packaged and labelled.
    • 1.3 Import control outcome
      • Imported foods meet food safety and other regulatory requirements, including labelling.
    • 1.4 Export control outcome
      • Exported foods meet foreign country import requirements and conditions and Canadian export requirements, where applicable.

The following performance criteria would have to be addressed by the regulated party to achieve the process and product control outcomes (1.1 and 1.2).

1.1Process control outcome: performance criteria

a. Incoming inputs (For example, ingredients and raw materials)

b. Product formulation and specifications

c. Processing

Rationale
  • Inadequate incoming ingredient / raw material controls could result in non-compliance (for example, product contamination, inadequate processing or misrepresentation of the product).
  • Inaccurate product formulation and/or mixing could result in non-compliance (for example, product adulteration, inadequate processing, etc).
  • Inadequate process controls could lead to pathogenic organisms, toxins, undeclared allergens and other hazards in the food.

1.2 Product control outcome: performance criteria

a. Packaging

b. Labelling

c. Finished Product

Rationale

Inadequate food commodity controls could result in:

  • the use of packaging that may contaminate or permit contamination of the food commodity,
  • inaccurate and incomplete information on labels, and
  • final product that is not compliant.

The additional performance criteria below would also have to be addressed by the regulated party to achieve the control outcomes for import and export (1.3 and 1.4).

1.3 Import control outcome: performance criteria

Rationale
  • Importers do not have direct control of the preparation of the food commodity; therefore, it is important to maintain effective strategies to source and verify that their products meet Canadian requirements.

1.4 Export control outcome: performance criteria

Rationale
  • Food commodities for export may contain ingredients that are not permitted in Canada. Segregation would prevent the food commodities from reaching the Canadian marketplace.

Element 1: Inspection activities for process and product controls

The following activities would be used to guide the inspector in determining compliance with the performance criteria and outcomes.

Inspection activities for sub-element 1.1: Process controls

a. Incoming Inputs (for example, ingredients and raw materials)

b. Product formulation and specification

c. Processing

Inspection activities for sub-element 1.2: Product controls

a. Packaging

b. Labelling

c. Finished product

Inspection activities for sub-element 1.3: Import controls

Inspection activities for sub-element 1.4: Export controls

Element 2: Sanitation and pest control: Outcomes and performance criteria

Expected Outcomes

  • 2.1 Sanitation
    • An effective sanitation program for equipment and premises is in place to prevent contamination of food.
  • 2.2 Pest Control
    • An effective pest control program is in place to prevent entry of pests, to detect and eliminate pests and to prevent the contamination of food.
  • 2.3 Chemicals
    • Chemicals are stored and used in a manner and under conditions that do not contribute to the contamination of food.

The following performance criteria would have to be addressed by the regulated party to achieve the sanitation, pest control and chemical outcomes (2.1, 2.2, 2.3 and 2.4).

2.1 Sanitation outcome: performance criteria

Rationale
  • Improper or inadequate sanitation activities can lead to contamination of food, packaging materials and food contact surfaces.
  • Cross-contamination from cleaning activities during operation can cause chemical or biological contamination.

2.2 Pest control outcome: performance criteria

Rationale
  • Pests (for example, insects, rodents and birds) can contaminate food, ingredients, packaging materials and food contact surfaces. Pests in or around an establishment can lead to contamination from droppings, larvae, and dead insects or animals.

2.3 Chemicals outcome: performance criteria

Rationale
  • The use of improper chemical concentrations and/or improper chemical application or rinsing procedures can lead to both chemical contamination (for example, chemical residue due to poor rinsing, no-rinse chemicals in excess of approved concentration) and biological contamination (for example, bacteria not effectively removed from food contact surfaces).
  • Improperly stored chemicals can lead to contamination of the food preparation environment.

Element 2: Inspection activities for sanitation and pest control

The following activities would be used to guide the inspector in determining compliance with the performance criteria and outcomes.

Inspection activities for sub-element 2.1: Cleaning and sanitation

Inspection activities for sub-element 2.2: Pest control

Inspection activities for sub-element 2.3: Chemicals

Element 3: Hygiene and employee training: Outcomes and performance criteria

Expected outcomes

  • 3.1 Hygiene and biosecurity
    • Employees and visitors are not a source of contamination of food, packaging materials or food contact surfaces.
  • 3.2 Employee training
    • Employees have adequate technical knowledge and understanding of operation(s) or process(es) for which they are responsible and of how they may impact food safety and other regulatory requirements.

The following performance criteria would have to be addressed by the regulated party to achieve the hygiene, biosecurity and employee training outcomes (3.1 and 3.2).

3.1 Hygiene and biosecurity outcome: performance criteria

Rationale
  • Personnel training and hygiene contribute to the production of safe food and biosecurity practices.
  • Employees and visitors who do not follow hygienic and biosecurity practices can cause food contamination.

3.2 Employee training outcome: performance criteria

Rationale
  • Proper training promotes an understanding of the risk of biological, chemical and physical contamination and the employee's role in maintaining hygiene and biosecurity.

Element 3: Inspection activities for hygiene, biosecurity and employee training

The following activities would be used to guide the inspector in determining compliance with the performance criteria and outcomes.

Inspection activities for sub-element 3.1: Hygiene

Inspection activities for sub-element 3.2: Employee training

Element 4: Equipment design and maintenance: Outcomes and performance criteria

Expected outcomes

  • Equipment, utensils and containers are designed, maintained and used in a manner that does not result in contamination of food or food packaging materials and are effective for the purpose for which they are intended.
  • Controlling or measuring devices are calibrated for accuracy.

The following performance criteria would have to be addressed by the regulated party to achieve the equipment design and maintenance outcomes.

Rationale
  • Poor design and installation can make it difficult to properly clean and maintain equipment.
  • Improper maintenance of equipment may lead to the contamination of food.
  • Improper use of equipment may lead to contamination of food.
  • Improper calibration or maintenance of controlling or measuring devices may lead to inadequate processing or inaccurate formulation of food or other regulatory non-compliance.

Element 4: Inspection activities for equipment design and maintenance

The following activities would be used to guide the inspector in determining compliance with the performance criteria and outcomes.

Element 5: Physical structure and maintenance: Outcomes and performance criteria

Expected outcomes

  • 5.1 Outside premises and surroundings
    • Conditions of the outside premises and surroundings do not contribute to the contamination of food.
  • 5.2 Buildings
    • Buildings are constructed and maintained to support cleaning and sanitation and prevent the entry of pests and contaminants.
  • 5.3 Water, ice and steam
    • Water, ice and/or steam that come into contact with food and/or food contact surfaces is potable or safe for intended use.
  • 5.4 Waste disposal
    • Effluent and waste storage and disposal systems are designed, constructed and maintained to prevent contamination of food, preparation areas or water.

The following performance criteria would have to be addressed by the regulated party to achieve the physical structure and maintenance and outside premises outcomes (5.1, 5.2, 5.3 and 5.4).

5.1 Outside premises and surroundings outcome: performance criteria

Rationale
  • Outside sources of contamination can compromise the safety and or quality of the commodity.

5.2 Buildings outcome: performance criteria

a. Exterior building structures

Rationale
  • Proper facility design and construction, including maintenance, prevents or mitigates the entry of pests or contaminants.

b. Interior building structures, appropriate for intended use

Rationale
  • Standing water can become stagnant and therefore a source of contamination.
  • Cleanable surfaces will support effective cleaning and minimize the build-up of unsanitary conditions (for example, presence of bacteria, mould).
  • Proper protection of glass will prevent foreign material contamination of food, ingredients, packaging materials and food contact surfaces.

c. Hygienic flow and separation

Rationale
  • Separation or control between incompatible operations helps to prevent cross-contamination of finished food.
  • Control is inadequate if cross-contamination occurs.

d. Lighting

Rationale
  • If lighting levels are inadequate, employees may not be able to properly carry out his/her activities (including processing, quality control, reading of critical instrumentation, cleaning and sanitizing).
  • If a light bulb or lighting fixture breaks over exposed food, ingredients, packaging materials or food contact surfaces, it presents a potential physical hazard.

e. Ventilation

Rationale
  • Adequate ventilation minimizes condensation which could contaminate food.
  • The flow of contaminated air through an establishment can be a source of contamination.
  • The ventilation system requires cleaning and maintenance so that it can function properly.

f. Employee facilities

Rationale
  • Adequate and clean washroom, change room and lunch room facilities will support personal hygiene and reduce the risk of contaminants or contamination.
  • Hand-washing and sanitizing stations can become a source of contaminants if they are not properly located, designed or maintained.

5.3 Water, ice and steam outcome: performance criteria

a. Water, ice and steam safety

Rationale
  • Since water, ice and steam can be used for a variety of purposes (for example, sanitation, hand washing, as an ingredient or processing aid), it is important that water be safe for use.

b. Water, ice and steam handling equipment

Rationale
  • Water, ice and steam can be a source of biological, chemical or physical contaminants.

5.4 Waste disposal outcome: performance criteria

Rationale
  • An effective waste removal and disposal system will reduce pest harbourage and the risk of cross-contamination of food, ingredients, packaging material, food contact surfaces or the safe water supply (for example, drain back-ups leading to flooding).
  • Cleanable and properly identified containers and utensils used for waste will prevent misuse that may result in cross-contamination.
  • The presence of mechanisms to prevent backflow (for example, trapping, venting) will prevent sewer gases, pests, micro-organisms or other contaminants from entering the establishment through the plumbing system.

Element 5: Inspection activities for physical structure and maintenance and outside premises

The following activities would be used to guide the inspector in determining compliance with the performance criteria and outcomes.

Inspection activities for sub-element 5.1: Outside premises and surroundings

Inspection activities for sub-element 5.2: Interior and exterior building structures

a. and b. Exterior and interior building structures

c. Hygienic flow and separation

d. Lighting

e. Ventilation

f. Employee facilities

Inspection activities for sub-element 5.3: Water, ice and steam

Inspection activities for sub-element 5.4: Waste disposal

Element 6: Receiving, transportation and storage: Outcomes and performance criteria

Expected outcome

  • Food commodities (including incoming ingredients) and packaging materials are transported, received and stored in conditions that prevent damage, spoilage and contamination.

The following performance criteria would have to be addressed by the regulated party to achieve the receiving, transportation and storage outcome.

Rationale
  • Food commodities may become contaminated, or may not reach their destination in a suitable condition, unless effective control measures are taken during transport or at loading/unloading and storage.
  • The safety and quality of food commodities that require temperature and humidity control can be impacted negatively if left at ambient temperatures and conditions for prolonged periods.

Element 6: Inspection activities for receiving, transportation and storage

The following activities would be used to guide the inspector in determining compliance with the performance criteria and outcomes.

Element 7: Traceability, recall and complaints: Outcomes and performance criteria

Expected outcome

  • 7.1 Traceability and recalls
    • Foods are adequately identified to enable removal from the marketplace.
    • Non-compliant food commodities are effectively prevented from entering the marketplace and can be rapidly retrieved from the marketplace if distributed, and disposed of, as appropriate.
  • 7.2 Complaints
    • Complaints related to food safety and product misrepresentation are investigated to determine root cause and corrective actions are taken.

The following performance criteria would have to be addressed by the regulated party to achieve the traceability, recall and complaints outcomes (7.1 and 7.2)

7.1 TraceabilityFootnote 15 and recall outcomes: performance criteria

Rationale
  • Identifying and controlling implicated food quickly and effectively is crucial for protecting consumers from preventable health risks.

7.2 Complaints outcome: performance criteria

Rationale
  • Complaints from any source (for example, consumers, other industry members, customers) are important indicators of possible deficiencies in the system. When the complaint handling system itself is deficient, it could result in failure to identify and eliminate risks.

Element 7: Inspection activities for traceability, recall and complaints

The following activities would be used to guide the inspector in determining compliance with the performance criteria and outcomes.

Inspection activities for sub-elements 7.1: Traceability and recall

Inspection activities for sub-element 7.2: Complaints

Annex C: Basic inspection steps

Details of basic inspection steps for inspectors

The following outlines the basic inspection steps that may be used by CFIA inspectors. It provides a consistent approach to performing inspections under the improved food inspection model.

Step 1: Prepare for the inspection

a. Determine preliminary scope of inspection.

Once a facility has been identified for inspection, based on the work plan and priorities, the scope of the inspection may be adjusted in response to:

Over time, the regulated party's entire system should be inspected to verify compliance with all food safety and other regulatory requirements.

b. Determine whether the inspection will be announced or unannounced.

Inspections may be announced or unannounced, at the inspector's discretion. Both approaches will be used.

c. Review the applicable Acts and regulations and other reference documents.

d. Gather inspection documents and tools, sampling equipment, protective wear, safety equipment and applicable supplies.

Step 2: Conducting the inspection

During the inspection, record all findings, including any discussions. Additional objective evidence, such as physical samples, photographsFootnote 16 and copies of documents may also be gathered.

a. Opening meeting
b. Initial walk-through inspection

This part of the inspection serves to identify areas that should be added to the scope of the inspection or targeted for more intensive inspection. It can also confirm the accuracy of the profile.

When outside the facility observe the general cleanliness of the surrounding area and any conditions that could contribute to food contamination.

Consider:

When inside the facility, begin at the finished product area and progress towards incoming product and ingredients areas. Observe the general cleanliness and any conditions that could contribute to food contamination.

Consider:

Document all observations. Make note of any questions to ask personnel that arise during the inspection or records that should be reviewed to help confirm observations.

c. Confirm the scope of inspection

Based on recorded observations from the walk-through, consider whether the scope of the inspection should be adjusted.

d. Complete the inspection
Review records

Review the preventive control plan and records for the elements that fall within the scope of the inspection. The number of records selected reflects performance over time. Focus on records for food commodities that will be prepared during the inspection so that employee actions can be observed and on-site interviews can be conducted.

Address the following for each element examined:

Review monitoring records to determine if:

Review verification records to determine if:

If there are repeated deficiencies, determine if the regulated party has implemented additional measures or made changes to the preventive control plan.

Any records supporting the preventive control plan can be checked during an inspection (for example, training records, consumer complaints). Be clear in describing the types of records to which access is required.

Use judgement to decide whether it is necessary to take samples of the food commodity or swabs of the equipment and environment to verify inspection observations and to help determine whether the regulated party is compliant. Send any samples collected to the appropriateCFIA laboratory for analysis.

Observe activities and conduct interviews

Use judgement to decide what to do first: observe operations or conduct interviews. There is no prescribed order to using these techniques–the objective is to collect the most accurate information possible.

During observations, confirm that the employees are following the preventive control plan procedures. Interview employees to gather further information to support the observations. Use open-ended questions such as:

If compliance is achieved with regulatory requirements, go to section f. Inspection report. If non-compliance is identified, the level must be assessed.

e. Assign a level of non-compliance

Assign a level of non-compliance to each element, based on its potential impact on food safety.

There are three levels of non-complianceFootnote 17:

Any other observations that do not have an impact on food safety or regulatory requirements may be noted in the report as "opportunities for improvement".

If any serious or critical non-compliance is detected, issue a corrective action request that indicates which regulatory requirement(s) have not been met. Record technical non-compliance. Though these must be corrected, a corrective action request need not be issued. All non-compliance, including technical, must be corrected by the regulated party.

Where critical food safety issues are observed, take the following steps:

f. Inspection report

The inspection report includes the inspection findings, corrective action requests issued, technical non-compliance observed and actions taken.

Documentation of the records reviewed includes the following:

Documentation of observations and interviews includes the following:

Record all incidents of non-compliance in the final inspection report. The nature of the non-compliance must be described in clear, factual and concise terms.

Step 3: Communicate the inspection results

Hold closing meeting with the regulated party to discuss the outcomes of the inspection, including any incidents of non-compliance and next steps. Share the written inspection report, once completed.

At the closing meeting:

Step 4: Conduct a follow-up inspection

A follow-up inspection may be needed to confirm that the corrective action has been completed, is effective, and that any changes to the preventive control plan are documented. An extension of the deadline for completing corrective actions may be granted in certain circumstances, including the following:

When reviewing corrective actions:

If the corrective actions have been implemented effectively, close the corrective action request.

If the corrective actions have not been implemented effectively and an extension is not granted, take the appropriate compliance and enforcement action.

a. Continued or repeated non-compliance
The following table shows guidelines for compliance and enforcement action in the case of continued or recurring incidents of non-compliance.
Continued or repeated non-compliance The inspector The regulated party is required to
For a critical non-compliance Initiates enforcement action (for example, suspension of licence) Take immediate action to address the non-compliance, and control the affected food commodity, if necessary
For a serious non-compliance Elevates to a critical corrective action request Control the affected food commodity immediately and address the non-compliance to prevent recurrence
For a technical non-compliance Initiates corrective action and appropriate enforcement (for example, AMPs, product seizure and detention) Correct the affected food commodity

Annex D: Compliance and enforcement: range of possible responses

The following is a list of the CFIA's possible responses to incidents of non-compliance, listed in no particular order of magnitude. This list is not comprehensive and more than one response may be used in any given situation.

a. Inspection

An assessment and verification of compliance of the regulated party to Acts or regulations administered or enforced by the CFIA.

b. Refusal to issue export certificate/documents

The Minister may refuse to issue export documents if the regulated party's export controls outlined in the preventive control plan were not effective or the food commodity did not comply with other federal legislative requirements or the requirements of the importing country. In these cases, the CFIA may consider lot-by-lot inspection to check for compliance.

c. Start or stop activities

If critical non-compliance were to be found during an inspection, the inspector may order any person who conducts an activity regulated under the SFCA to start or stop the activity.

d. Seizure and detention

Seizure and detention allow the CFIA to control anything that the inspector has reasonable grounds to believe was used or obtained in contravention of any provision of the SFCA or the regulations. For example, a food commodity can be seized and detained until:

e. Removal or destruction order

If an importer does not possess a valid licence or if an imported food commodity does not comply with legislative requirements or is imported illegally, the inspector may order the food commodity removed from Canada, or if removal is not possible, destroyed.

f. Corrective action request

A corrective action request is an inspection document that the CFIA issues to a regulated party in cases of serious or critical non-compliance. The corrective action request requires the regulated party to undertake a corrective action and to implement corrective measures within a defined timeframe.

g. Meeting with the regulated party

If non-compliance is not resolved, a meeting may be held with the regulated party to discuss the need to apply corrective actions, set timelines and outline possible further action if the non-compliance were to remain unresolved.

h. Notice of non-compliance

The regulated party may be sent a notice of non-compliance if he/she has failed to respond to the CFIA's corrective action request and further enforcement action is being considered.

i. Publication of non-compliance

Compliance and enforcement actions may be published on the CFIA website.

j. Dispose

A food commodity (or anything) that has been seized under the SFCA may be ordered disposed of if the thing is perishable or it presents a risk of injury to human health and its disposal is necessary to respond to the risk.

A seized product may also be disposed of or destroyed if it has been forfeited or if the regulated party consents to its disposal.

k. Injunction

On application by the Minister, the court may order a person to stop doing an activity that may be in violation of the SFCA, or start an activity to prevent the commission of an offence under this Act. Under section 18 of the Canadian Food Inspection Agency Act, the CFIA may apply to a court of competent jurisdiction for an interim injunction.

l. Recall

Recalling a product would be appropriate when there are reasonable grounds to believe the regulated product poses a risk to the public or animal or plant health. If the regulated party were to refuse to initiate a recall of the product, a recall order may be issued pursuant to section 19 of the Canadian Food Inspection Agency Act, which provides that: "the Minister may, by notice served on any person selling, marketing or distributing the product, order that the product be recalled or sent to a place designated by the Minister."

m. Actions taken with regard to licences

A licence may be suspended and/or cancelled if the licence holder does not comply with the regulatory requirements or conditions of the licence. Refer to the licensing section (Section 2) for a list of grounds and more details.

Furthermore, the Minister may make a licence subject to any additional conditions that he/she considers appropriate.

n. AMPs

Under consideration and will be consulted on during the food regulatory modernization initiative.

o. Recommendation to prosecute

The Public Prosecution Service of Canada (PPSC) has the responsibility for all prosecutions relating to legislation enforced by the CFIA. If the CFIA were to conclude that prosecution is the most appropriate response, briefs of evidence would be forwarded to the PPSC with the recommendation that charges be laid. The PPSC would then decide whether to initiate prosecution.

Annex E: Complaints Process

Who can make a complaint?

The Complaints and Appeals Office (CAO) accepts comments, compliments and complaints from anyone who has dealings with the CFIA, on matters related to the quality of the CFIA's service delivery or decisions made by CFIA staff which are typically regulatory in nature. This includes regulated parties, stakeholders, and members of the public.

How can a complaint be made?

A complaint can be made in a variety of ways:

Submitting a complaint

Completion of the CAO intake form is required.

The CAO encourages persons with a complaint to try to resolve the complaint directly with the CFIA staff who are involved. If that does not work, an attempt to speak with that employee's supervisor (manager or director) before bringing the complaint to the CAO is encouraged. This incremental approach gives the employees and their management team, the opportunity to resolve complaints before they escalate.

CAO acknowledges complaints

The CAO will acknowledge a complaint by email, by phone or by fax within two business days of receipt of the complaint. The complaint will be assigned a file number for future reference.

Making a complaint

Individuals may make a complaint about any CFIA service, action, decision, regulation, policy, program or procedure or treatment. This includes situations when an individual:

Complaints should be made within 12 months of the incident or CFIA decision that is the focus of the complaint.

The CAO does not normally accept complaints about issues that occurred more than a year ago unless there are special circumstances associated with the matter. For instance, if new information has come to light or there has been a further development, the CAO will then consider reviewing the matter.

Are there complaints that the CAO will not review?

The CAO triages the complaint to determine whether it falls within the CAO mandate and can therefore be reviewed. A complaint will fall into one of the following categories:

a. Existing Process – when the CAO determines there is already an existing mechanism to deal with the complaint. Examples include:

b. No review – when the CAO determines that they cannot investigate the matter. These are generally issues that are already before the courts. In addition, they could be events that occurred more than 12 months in the past.

c. Review – when the CAO determines the complaint relates to CFIA quality of service or regulatory program or other decision made by CFIA officials. These generally include matters of staff behaviour, undue delays, poor or misleading information, mistakes, administrative errors, decisions related to licensing, registration, permits, orders, inspection results, seizure, labelling and other items.

Can the person complaining remain anonymous?

All of the information that is provided to the CFIA is subject to the Access to Information Act and the Privacy Act. The Access to Information Act gives Canadian citizens the right to access information in federal government records. The Privacy Act gives Canadian citizens, as well as individuals present in Canada, the right to access their personal information which is held by the Government and protection of that information against unauthorized use and disclosure.

On request, the CAO will make every attempt to treat the complaint anonymously. In some situations, it may not be possible to complete a comprehensive review without disclosing information (e.g., name, company name etc.) to CFIA officials. This decision will be made on a case by case basis.

Reviewing the complaint

A Complaints Analyst will request a call with the complainant to gather more information about the complaint and to ensure that he or she has a good understanding of all of the details.

Once the complaint is thoroughly understood and has been reviewed, the Complaints Analyst will conduct a preliminary inquiry within the CFIA which may include:

Once all of the relevant information has been gathered and the complainant and the Agency contact have had an opportunity to provide comments, the CAO will consider both viewpoints before making a determination about the incident. The CAO may find that the CFIA's actions or decisions were reasonable, or that the matter has been adequately addressed or the Complaints Analyst may make recommendations to the CFIA on reconsidering the matter. The complainant and the Agency management will be informed of the decision and the rationale for the findings.

The CAO is an impartial office. After reviewing all information and documents/policies that are relevant to the issue, the CAO will determine if CFIA decisions and actions are being implemented consistently as per the established procedures, in a timely manner and professionally as outlined in the CFIA's Statement of Rights and Service.

The CAO is currently operating as an administrative redress office which means that it does not have the legal authority to modify specific CFIA decisions. If the CAO – through the review process – identifies a specific CFIA decision that should be reconsidered, the CAO advises CFIA management. A request for review by the CAO does not change or stay the CFIA decision under review. The decision remains valid and enforceable while the review is taking place.

Occasionally, the CAO may find, after speaking separately with the complainant and the Agency, the best next step is to facilitate discussions between the complainant and the CFIA. Once communications are restored and there is willingness to work together to resolve a matter, the CAO will close the file to allow the complainant and the Agency to continue working toward a successful resolution on their own. All complainants are invited to return to the CAO if they remain dissatisfied after their discussions with the way the CFIA has addressed or failed to address their complaint.

Closing a complaint

Following the review of the file the CAO will contact the complainant by telephone with information, options, next steps and final decisions. The CAO will send this same information to the complainant in writing following the closing telephone call. Once the complainant receives the letter outlining the outcome, the complainant may have additional comments. The complainant can contact the CAO office and it will work to find answers.

What happens after a complaint is closed?

The Chief Redress Officer will sometimes highlight potential opportunities for improvement to CFIA's senior management. These recommendations could range from the identification of policies or procedures that need to be updated or clarified to areas that could benefit from improved service delivery.

Timeframes

The CAO will try to resolve a complaint as quickly as possible. The CAO takes all complaints seriously and it will keep the complainant up to date with regular feedback throughout the review of the matter. The length of the review will depend on the level of complexity of the matter and the availability of the complainant and CFIA officials to contribute to the information gathering stage of the review.

Within two business days the CAO will send an acknowledgement that it received the complaint and assign a file number for future reference. Other service standards are in development.

Records Management

The CAO will make every attempt to treat a complaint anonymously if it is the complainant's preference to do so. This decision is taken on a case by case basis as it may not always be possible to carry out a comprehensive review without full disclosure of information.

The CAO will only share information about the complaint file with the CFIA on a "need to know" basis. Sharing information may be required to allow the CAO to carry out its duties and perform a thorough review. For example, if the CAO is asking the CFIA for information about an incident that has been reported to it, the CAO may need to disclose some information about the complaint in order to obtain the CFIA perspective on the matter.

Annex F: Exemptions

The SFCA is an act respecting food commodities, including:

Within the Act, in the section that provides the Governor in Council the authority to make regulations, paragraph 51(1)(w) provides for exempting, or permitting the Minister to exempt, with or without conditions, any item to which the Act applies. In addition, the paragraph provides that any person or activity in respect of a food commodity may be exempted from the application of the Act or the regulations or a provision of the Act or the regulations.

The existence of this authority within the Act provides some flexibility to manage situations in which it would be appropriate for the provisions of the Act or regulations not to apply to a particular activity, food commodity or regulated party without compromising food safety.

Different types of exemptions are provided for within the legislation currently administered and enforced by the CFIA. Some are more temporary, while others are specific to a commodity sector's operating environment. Exempting provisions often apply to persons or classes of persons who carry out a specific activity or class of activities in relation to a food commodity.

As part of inspection modernization and regulatory modernization initiatives, the CFIA is examining how best to:

As part of the exercise, the CFIA is assessing the exemption provisions included in current commodity sector–based food regulations made pursuant to the Meat Inspection Act, Fish Inspection Act, and Canada Agricultural Products Act. In considering exemptions, for example, it is not the intention of the CFIA to regulate the preparation of food for one's own personal enjoyment, or the importing of food for one's own personal use. At the same time, it is recognized that an exemption that permits the importation of food commodities that do not meet Canadian requirements may be required to meet specific operational needs of regulated parties; for example, a non-compliant food commodity is imported for further processing, preparation or conditioning in Canada. In these cases, it is expected that the final product would meet Canadian requirements if it is sold in Canada.

Further consultation on exemptions will be performed during the regulatory modernization initiative. In all cases, if the food commodity is intended to be consumed, it must meet Canada's food safety requirements.

Annex G: Glossary of terms

This glossary of terminology is designed to standardize the language used by the CFIA's Food Business Line and support consistent interpretation of terminology used in the food inspection program.

A

Applicant (Demandeur)
Any person who applies for a licence, exemption or certificate.

B

Biological hazard (Danger biologique)
Any illness- or disease-causing pathogens or micro-organisms that pose a danger to food safety.

C

Certification (Certification)
Written assurance from a competent authority that foods or preventive control systems conform to requirements.
Chemical hazard (Danger chimique)
A chemical substance that poses a danger to food safety.
Compliant food (aliment conforme)
Food commodities that meet food safety and other regulatory requirements.
Competent authority (Instances compétentes)
A government agency or department having jurisdiction to perform a regulatory or enforcement function or both.
Contaminant (Contaminant)
Any biological, physical, chemical agents or other substances that are present in food and that compromise food safety or suitability.
Contamination (Contamination)
The presence of any contaminant in food or food contact surfaces.
Control measure (Mesure de contrôle)
Any action or activity that can be used to preventFootnote 18 or eliminate a food safety hazard or reduce it to an acceptable level. (Hazard Analysis and Critical Control Point System and Guidelines for Its Application, Annex to CAC/RCP 1-1969 (Rev.4 – 2003), FAO/CODEX)
Corrective action (Mesure corrective)
The steps that a regulated party takes to address non-compliance, which can include controlling affected product, conducting root cause analysis and preventing recurrence.
Corrective action request (CAR) (Demande de mesure corrective [DMC])
A document that the CFIA issues to a regulated party in cases of serious or critical non-compliance. The corrective action request describes the non-compliance and requires the licence holder to take corrective actions.
Critical non-compliance (Non-conformité critique)
Repeated serious non-compliance or non-compliance that has an immediate impact on food safety.
Cross-contamination (Contamination croisée)
A situation that occurs when hazards that are carried by utensils, equipment, surfaces or food handlers are transferred from one food, ingredient or surface to another.

D

Distributor (Distributeur)
A person, including a wholesaler, who distributes food or other materials.
Distribution centre (Centre de distribution)
A warehouse or other specialized building that is stocked with food or things to be redistributed to retailers, wholesalers or directly to consumers.

E

Employee (Employé)
A person who is employed by a food operation or establishment.
Establishment (Établissement)
Any place, including a conveyance, where a food commodity is manufactured, prepared, stored, packaged or labelled. (Safe Food for Canadians Act)
Exporter (Exportateur)
Any person who sells or trades food from Canada to another country.
Exposure assessment (Évaluation de l'exposition)
The qualitative and/or quantitative evaluation of the likely intake of biological, chemical and physical agents via food as well as exposures from other sources if relevant (Codex)

F

Food grade materials (Matériaux de qualité alimentaire)
A designation that means that a material is safe for human consumption, is permitted to come in contact with food contact surfaces or is food intended for human consumption.

I

Importer (Importateur)
Any person in Canada who imports food commodities into Canada.
Ingredient (Ingrédient)
An individual unit of food that is combined as an individual unit of food with one or more other individual units of food to form an integral unit of food that is sold as a prepackaged product (Food and Drug Regulations)

M

Monitoring (Suivi)
The act of conducting a planned sequence of observations or measurements of control parameters to assess whether a control measure is under control. (Codex)

N

Non-compliance (Non-conformité)
The state that occurs when a regulated party or thing does not conform to statutory or regulatory requirements.
Not ready-to-eat food (Aliment qui n'est pas du prêt-à-manger)
Foods that require a cooking step before consumption by consumers for safety. The cooking step is required to kill pathogenic micro-organisms that may be present in the food.

O

Objective evidence (Preuve objective)
Information directly collected by an inspector through observation, measurement, testing or other means.
Oversight (Surveillance des parties réglementées)
Inspection activities designed to determine whether a regulated party is complying with Acts and regulations administered or enforced by the CFIA

P

Pests (Organismes nuisibles/parasites)
Any animal, plant, fish or insect of public health importance including, but not limited to, birds, rodents, roaches, flies and larvae that may carry pathogens that can contaminate foods.
Physical hazard (Danger physique)
Any foreign materials that are not normally found in food and that pose a danger to food safety.
Premises (Lieux)
The lands, buildings and facilities where food is prepared.
Prepare (Conditionnement)
In respect of a food commodity, includes to process, treat, preserve, handle, test, grade, code or slaughter it or to do any other activity in respect of it that is prescribed.
Preventive control plan (Plan de contrôle préventif)
A combination of control measuresFootnote 19 that, when taken as a whole, provide for a science-based approach to managing risks posed by hazards.
Primary producer (Producteur primaire)
A person who cultivates, grows, produces, raises, picks or harvests agricultural products or fishery products and does not alter the nature of the raw product.

R

Ready-to-eat food (aliment prêt-à-manger)
  1. do not require any further preparation before consumption, except perhaps washing/rinsing, thawing or warming for aesthetics or palatability
  2. are in a form that is edible without additional preparation to achieve food safety
  3. do not require further preparation or cooking before consumption
  4. are ordinarily consumed in the same state as that in which they are sold
 
Regulated party (Partie réglementée)
A person (including an individual, corporation, partnership or organization) carrying on business in Canada who is subject to the Acts and regulations administered by the CFIA.
Representative sample (Échantillon représentatif)
The collection of a selected portion or subset of the thing that is intended to provide information on a given characteristic and that accurately reflects the characteristics of that thing.
Requirements (Exigences)
The criteria set down in acts or regulations administered or enforced by the CFIA.
Risk (Risque)
A function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard(s) in food.
(CODEX Procedural Manual, 20th Edition, FAO, 2011)
Risk-based inspection (Inspection fondée sur le risque)
A method for using risk to prioritize and manage inspection efforts.
Risk characterization (Caractérisation des risques)
The qualitative and/or quantitative estimation, including attendant uncertainties, of the probability of occurrence and severity of known or potential adverse health effects in a given population based on hazard identification, hazard characterization and exposure assessment (CODEX)

S

Serious non-compliance (Non-conformité grave)
Non-compliance that has a potential impact on food safety.
Surveillance (Surveillance)
The collection, analysis and interpretation of food sampling and inspection information to establish baseline data or identify trends.
Systems-based approach (Approche axée sur un système)
An integrated, flexible, multi-faceted approach to analysing and managing risk that considers the underlying actions of all of the steps or processes and controls that make up food production.

T

Third-party verification (Vérification par une tierce partie)
The use of a private, independent service provider, organization or company to verify that a regulated party has adhered to a standard.

V

Validation (Validation)
Obtaining evidence that a control measure or combination of control measures, if properly implemented, is capable of controlling the hazard to a specified outcome. (CODEX, Guidelines for validation of food safety control measures, CAC/GL 69-2008)
Verification (Vérification)
The application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine whether the control measure is or has been operating as intended. (CODEX, Guidelines for validation of food safety control measures, CAC/GL 69-2008)
Violation
(Infraction)
Any contravention of the acts or regulations administered or enforced by the CFIA or any refusal or neglect to perform any duty imposed by or under the acts or regulations

Additional resources

Codex Alimentarius Commission

Department of Justice, Food and Drug Regulations, C.R.C, c. 870

Health Canada, Food Directorate, Food-related health risk assessment

Risk-based Inspection as part of an Overall Inspection Management Program

Date modified: