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Integrated Agency Inspection Model – Consultation Draft (December 4, 2013)

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Canada has one of the best food, animal and plant inspection systems in the world. With pressures from increased globalization and advances in science and technology, the Canadian Food Inspection Agency (CFIA) is modernizing its approach to inspection to maintain a robust approach to human, animal and plant health and consumer protection. The move towards a more preventative and systems-based approach under the integrated Agency Inspection Model enables both the CFIA and regulated parties to more readily adapt to emerging risks and global and scientific trends. Canadians will continue to be protected by an effective system that is both science and risk-based.

The improved food inspection model (iFIM) will become the integrated agency inspection model (iAIM).

The improved food inspection model, finalized June 2013, provides the foundation for the incorporation and integration of the animal and plant commodity inspection programs. The improved food inspection model has been revised to create this Draft integrated Agency Inspection Model. All of the requirements, activities and actions described herein were developed to promote the preparation, importation and exportation of commodities that are safe and healthy and in compliance with federal legislation in Canada.

Animal and plant commodity activities (fertilizer, seed, plant health, feed and animal health) have been incorporated to fully align the strategic outcomes for all CFIA inspection work. This has involved expanding the context of a commodity beyond just food. Broader language has been employed to reflect the full Agency mandate.

Four key areas have been adjusted:

The glossary of terms has been revised, it is a good starting point to promote better understanding.

The model represents the CFIA's vision and its approach to regulatory inspection. The integrated Agency 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 Permissions, CFIA Oversight, Inspection, Regulatory Response, and System Performance.

Figure 1 identifies the CFIA functions and the model components.

Figure 1 – CFIA Functions and the model components. Description follows.
Figure 1 – CFIA Functions and the model components

The image illustrates the framework of the draft integrated agency inspection model. The image is composed of a pentagon with a number of circles around it, all above a horizontal and rectangular base divided into separate boxes.

  • The pentagon comprises five equal, pie-shaped wedges that represent five key components of the draft inspection model.
  • At the center of the pentagon are two boxes that represent the types of inspector that would be required to deliver the new model.
  • The nine circles around the pentagon represent the various business areas and the business functions of each area that would be required to deliver the new model.
  • The base represents nine components of a foundation that would be required to deliver the new model.


The pentagon's five pieces read as follows (from top right going clockwise):

  • CFIA oversight
  • Permissions
  • Inspection
  • Regulatory Response
  • System performance

The two boxes at the center of the pentagon are titled "Inspectors" on the left and "System Assessment Officers" on the right.


The nine circles that represent agency business areas and that are placed around the pentagon read as follows (starting top right, going clockwise).

  1. Risk assessment
  2. Program management
  3. Licensing
  4. Field operations
  5. Exports
  6. Imports
  7. Control and compliance
  8. Enforcement
  9. Redress of complaints and appeals


The horizontal and rectangular base across the bottom consists of six boxes that read, from left to right:

  1. Human resources (framework)
  2. Organizational design
  3. Training
  4. Culture and integrity
  5. Communication, stakeholder engagement and transparency
  6. Information management and technology
  7. Legislative and regulatory framework
  8. Business architecture
  9. System performance management

Since 2013 and continuing in the years thereafter, the CFIA will be phasing the model into operation. More information about implementation and the phased-in approach for the model and proposed commodity regulations will be provided to stakeholders.

Guide for navigating the document

1.0 Introduction

A key component of the model is the use of licensing as a tool to identify and authorize a regulated party to conduct an activity. Section 2 and Annex A outlines 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 (PCPs) suitable to the size and complexity of their operations. Section 3 and Annex B provide additional details on the proposed elements of the preventive control plan and the expected outcomes and performance criteria. CFIA staff would be guided by the inspection activities described in Annexes B and C to assess how effectively a licence holder's preventive control plan demonstrates regulatory compliance with the expected outcomes.

Section 4 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 place a higher priority on oversight of regulated parties for which the consequence of non-compliance would have a greater impact on human health, animal health, plant health or the environment.

Section 5 and Annex C provide an overview of inspection and the general procedures inspectors would follow when conducting an on-site or follow-up inspection.

Section 6 and Section 7 cover the unique aspects associated with imported and exported commodities. 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 foreign country's import requirements.

Section 8 and Annex D are dedicated to a single, streamlined regulatory response across all commodities. Annex D provides an overview of the range of possible responses the CFIA may use to respond to an incident of non-compliance or a pest /disease/contaminant event.

Section 9 and Annex E describe the CFIA's review mechanism, the complaint process, and the role of CFIA's Complaints and Appeals Office.

Section 10 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 11 provides a general overview of how transparency would be achieved under the model. The CFIA is committed to providing stakeholders with useful and timely information on its programs and services, regulatory requirements, and the outcomes of its enforcement actions and decisions.

Annex F provides a glossary of terminology. It is designed to standardize language and support consistent interpretation of terminology used in Agency inspection programs.

1.1 CFIA's legislative authorities

The CFIA is dedicated to safeguarding human and animal and plant health and the environment, which enhances the health and well-being of Canada's people and economy.

The CFIA develops and delivers inspection and other services to:

The CFIA bases its activities on science, effective management of risk, commitment to service and efficiency, availability of resources and collaboration with domestic and international organizations.

The CFIA has a mandate to administer and/or enforce the following Acts and the regulations made under them.

The CFIA has begun a systematic review of its regulatory frameworks for food, plant and animal commodities. With its broad mandate for human, animal and plant health and the environment, the CFIA recognizes the need for and the importance of the 13 federal statutes and associated regulations for which it is responsible. The CFIA has been engaging Canadians, industry stakeholders and other government departments, including federal partners as part of regulatory modernization. The CFIA recognizes the importance of supporting Canadians' access to healthy and sustainable agricultural, forestry and aquaculture products, while at the same time creating and maintaining a regulatory environment that supports competitiveness and innovation in the Canadian agricultural sector. Modernized regulatory frameworks will improve consistency and reduce complexity in regulation and align with inspection modernization.

Effective regulation contributes to the health and safety of Canadians, the protection of the animal and plant resource bases and the environment, and to a strong economy. The regulatory renewal initiatives for each of the CFIA's business lines, those being Plant, Animal, and Food have been prioritized.

The Agricultural Growth Bill was tabled in parliament December 9, 2013. It is a bill designed to modernize and strengthen federal agriculture legislation, support innovation in the Canadian agriculture industry and enhance global market opportunities. The bill proposes changes to the suite of statutes that the CFIA uses to regulate our agricultural sector. Seed, fertilizer and feed regulatory renewal work is underway, while animal and plant health frameworks are commencing.

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. Regulations are currently being developed in accordance with the authorities of SFCA. Stakeholder consultations are underway. When the SFCA is fully in force, these Acts and their regulations will be repealed. The SFCA does not change the inspection regime or the fines and penalties of the Food and Drugs Act (FDA) and its regulations.

The FDA and its 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 foods that are unsuitable for human consumption, including those marketed exclusively within provinces. Once the SFCA is fully 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. In the interim, the existing legislation will remain in force.

In most of the Acts administered and enforced by the Agency, the Governor in Council is provided the authority to make regulations exempting, or permitting the Minister to exempt, any person, item or activity to which the Acts apply. In addition, there may be provisions exempting any person or activity from the application of the Acts or their regulations. Further consultation on exemptions will be undertaken during regulatory modernization.

1.2 Guiding principles

The CFIA's integrated Agency Inspection Model will apply globally recognized risk management concepts based on prevention. They include systems-based, performance-based and risk-based approaches that are:

1.3 Roles and responsibilities

1.3.1 Regulated parties

Regulated parties are responsible for complying with the law. They demonstrate this commitment by ensuring that the 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 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. When non-compliance is identified, the CFIA takes appropriate compliance and enforcement action.

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

The CFIA derives its inspection and enforcement authorities through its Acts. In light of modernization, the CFIA will develop a common suite of inspection policies and procedures supplemented by commodity-specific inspection materials, as necessary. These materials will clearly link the regulations to their policy intent and provide functional direction to CFIA staff regarding the regulatory requirements to be verified.

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

1.3.3 Key partners

The CFIA works with its partners to manage regulated risks and emergencies; and promote the development of control systems to maintain the safety of Canada's high-quality agriculture, agri-food, forestry, aquaculture and fishery products.

The CFIA's Key Federal Partners:

The Canada Border Services Agency (CBSA) will continue to clear shipments into Canada with the assistance of the CFIA, but its officers will now confirm that importers have a valid licence. The CFIA's electronic certification processes are to 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 "program legislation", including CFIA 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.

Figure 2 – Roles and Responsibilities of Partners. Description follows.
Figure 2 – Roles and Responsibilities of Partners
  • Global food supply
  • Market access and trade
  • Comparability and acceptance of food systems
  • Meet import requirements, provide export requirements
  • Compliance with international standards
Provincial/Municipal agencies
  • Enforce food safety laws with their jurisdiction
  • Inspection, public health and food safety, animal and plant health surveillance
Federal Partners
  • Develop policies and standards within their mandate as they relate to public health, food safety and the environment
  • Delivers federal food inspection programs
  • Develops policies and standards as they relate to animal and plant health, seed, feed and fertilizer
  • Investigates complaints, outbreaks and illnesses
  • Responsible for meeting regulatory requirements for the production of compliant commodities
  • Responsible for safe handling of food, animals and plants

2.0 Permissions


CFIA grants permission authorizing regulated parties to conduct specific activities to meet regulatory requirements.

There are two types of permission:

Permissions are used to describe all relevant activities the applicant is approved to conduct and include licences, permits and certificates (e.g. for export, domestic movement). An applicant may request permission for each physical location, a number of physical locations, a type of commodity or activity (e.g. import, export).

Frequent and/or commercial regulated parties will be required to have effective preventive control plans in place to be licensed. Parties participating infrequently in regulated non-commercial activities (for example one-time imports or exports of a regulated article) subject to plant or animal health requirements may be eligible for permissions without preventive control plans. An applicant for a licence must be located in Canada or have a resident agent while they are a licence holder, to enable the CFIA to carry out inspection activities and take compliance and enforcement actions as necessary.

Primary producers, such as growers, fishers and livestock producers are not expected to be covered by the proposed licensing regime. In circumstances where primary producers choose to import or export or are subject to domestic animal and plant health requirements (i.e. those premises considered to be high risk), a licence would be required. Primary producers are expected to comply with applicable Acts and Regulations.

Permissions may be amended or suspended to address a disease outbreak, plant pest detection or contaminant event (such as a nuclear event) that is not addressed by the conditions of an existing licence.

Regulated parties will be required to immediately notify the CFIA when they have reason to believe there is a non-compliance that has an impact on human, animal or plant health or the environment. The CFIA will take steps appropriate to the nature and severity of the issue.

2.1 Parties subject to licensing with a PCP

A licence will be required for most regulated parties who are subject to the Acts and regulations administered and enforced by the CFIA to:

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

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

2.1.1 Licensing requirements with a PCP

In order to obtain a licence, an applicant must:

  1. develop, implement, and maintain an effective written preventive control plan to meet regulatory requirements,
  2. complete an application, and
  3. pay the licence fee.

An applicant for a licence will be required to attest to having implemented a preventive control plan that is commensurate with the nature of their operations and meets the criteria set out in Section 3 and Annex B, as applicable.

2.1.2 Period of validity of a licence with a PCP

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

2.1.3 Issuing, renewing and amending a licence with a PCP

The following subsections outline the approach that is proposed for issuing, renewing and amending a licence. Additional information on the approach can be found in Annex A. Issuing a licence with a PCP

In order to obtain a licence, the applicant will be required to submit a licence application to the Minister (or CFIA delegate of the Minister). A new licence will be required anytime the ownership of a business (legally responsible party) changes.

A pre-licensing inspection may be required for high-risk activities and will be a priority for first-time applicants. Notifications will be sent to the applicant when a pre-licensing inspection is required. Renewing a licence with a PCP

A licence holder will be required to apply for renewal before the end of the licence's period of validity. A licence will not be renewed if there are any outstanding fees. Amending a licence with a PCP

A licence holder will be required to request an amendment to the licence when there is a change in the business profile or operations. The licence holder's preventive control plan may need to be updated to reflect those changes.

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

2.1.4 Suspension of a licence with a PCP

Reasons to suspend a licence include the following:

The suspension will continue until the reason for the suspension is resolved or, if unresolved, until a decision to cancel the licence is rendered or the licence has expired. The purpose of a licence suspension is to protect Canadians while allowing a licence holder the opportunity to come back into compliance.

If a licence expires while it is under suspension, it will not be renewed until the reason for suspension had been resolved.

2.1.5 Cancellation of a licence with a PCP

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

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

2.2 Parties subject to permissions without PCPs

Permissions without PCPs will be issued on a case-by-case basis to deal with particular one-time or low frequency non-commercial situations related primarily to animal or plant health requirements.

By exception, permissions without PCPs will be issued on a case-by-case basis to deal with particular one-time or low frequency activities.

A non-transferable permission without a PCP for a single transaction will be issued to the applicant to carry out the activity. The permission would describe all relevant activities the applicant is approved to conduct or the conditions the commodity must meet.

Such permissions will convey to regulated parties authorization to conduct a specific activity under specific conditions to mitigate risk, as needed. Examples where a permission without PCP may be applicable include:

This provides for flexibility and control over movement/disposition of products or things. Permissions without PCPs may include conditions for entry, movement or exit of regulated articles.

Regulated parties operating under permission without a PCP will be subject to regulatory requirements and CFIA inspection and oversight.

2.2.1 Permission requirements without a PCP

In order to obtain a permission without a PCP, an applicant must

  1. complete an application,
  2. pay the fee,
  3. meet the conditions for a permission without a PCP

Applicants will be required to attest to having met the conditions of the permission without a PCP. Examples of those conditions include, but are not limited to:

2.2.2 Period of validity of a permission without a PCP

Permissions without a PCP will be issued for a specified period of time and for a single transaction.

2.2.3 Issuing and amending a permission without a PCP

The following subsections outline the approach that will be used for issuing, renewing and amending a permission. Additional information can be found in Annex A. Issuing a permission without a PCP

In order to obtain permission without a PCP, applicants will be required to submit an application to the Minister (or CFIA delegate of the Minister).

An inspection may be required. Amending a permission without a PCP

Permissions without a PCP may be amended prior to use if there are changes to the conditions under which it was granted.

2.2.4 Suspension of a permission without a PCP

If there is a reason to believe that human, animal, or plant health or the environment may be endangered, a permission without a PCP may be suspended.

The suspension will continue until the reason for the suspension was resolved or, if unresolved, until a decision to cancel the permission without a PCP was rendered.

2.2.5 Cancellation of a permission without a PCP

Permissions without a PCP may be cancelled for reasons that include the following:

It may also be cancelled at the request of the permission holder.

3.0 Preventive control plans

A preventive control plan describes a systems-based approach that focusses on prevention as a way to achieve regulatory compliance. Preventive control plans are recognized internationally as an effective way to mitigate risks and minimize hazards.

A preventive control plan, suitable to the operations, must be developed, documented, implemented, and maintained, as a condition of a licence. 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 commodities, and the principles related to biosecurity and biocontainment. The requirement for the preventive control plan will be set out and/or referenced in regulation. Preventive control plans must be made available to the CFIA upon request.

The process of managing a preventive control plan will continually generate new information that could be used to actively improve operations in ways that foster regulatory compliance. Management commitment is essential to the implementation and ongoing maintenance of an effective preventive control plan. Consistent communication is key to meeting human, animal or plant health or other regulatory requirements. In addition, management must ensure that employees and service providers:

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), the International Organization for Standardization (ISO), the Canadian Seed Institute (CSI)) and the mandatory Hazard Analysis and Critical Control Points (HACCP) approach presently employed in some hatcheries. The approach would accommodate most systems currently in use by industry. The proposed preventive control plan requirements are similar to HACCP systems, but differ in that the proposed plans must also address other regulatory requirements (for example, animal health, plant health, labelling, product quality, composition). Regulated parties, including those currently operating under a systems approach such as mandatory HACCP, would be able to transition to the new model with little or no adjustment.

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

The CFIA is considering the development of model systems and tools to assist small businesses in meeting this requirement. The CFIA's Compliance Promotion Strategy is currently under development and will outline how regulated parties can seek guidance.

Regulated parties who strive to adopt the best practices and innovative, commercial or technological strategies would be recognized by the CFIA through adjustments to oversight, as appropriate.

3.1 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, biosecurity, biocontainment, pest control and chemicals
  3. hygiene, biosecurity and employee training
  4. equipment design and maintenance
  5. physical structure, surroundings and maintenance
  6. receiving, transportation and storage
  7. traceability, recall and complaints

Each element listed above must address the following criteria:

a. Hazards and controls

The plan would have to:

b. Monitoring procedures

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

c. Verification procedures

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

d. Corrective actions

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

e. 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:

f. Records

Records are evidence that the regulated party has implemented the preventive controls as designed and that it is effective. Regulated parties would generate a number of different types of records, suitable to their operations. These must be available for review by the CFIA.

The preventive control plan would need to identify all records associated with each element of the preventive control plan. It would also indicate where and for how long the records would be retained, including, but not limited to:

4.0 CFIA Oversight


Risk is the product of the probability of an adverse event and the severity of its impacts. Biological, chemical and physical hazards which threaten human, animal or plant health or the environment are considered in assessing risk. The likelihood of a hazardous event (e.g., the food-borne organism, invasive plant pest, or animal disease in question) and the magnitude or severity of its impacts following exposure are key components of risk assessment. Additional risk factors may also include impact on consumer protection and market fairness (e.g. product misrepresentation and substitution).

Risks must be managed or eliminated during production, processing, importing and distribution. It is the responsibility of regulated parties to:

The CFIA currently follows a variety of risk management approaches which reflect differences in the international foundations, legal frameworks and industry practices that influence the CFIA's risk oversight activities.

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

As part of its modernization efforts, the CFIA will enhance its risk-based approach to its oversight activities, and will adopt a more structured and transparent approach to allocating resources. This will utilize more modern methods and tools, thus ensuring a standard and consistent approach to oversight (e.g., inspection, audits, directed sampling and testing, etc.) without compromising human, animal or plant health, the economy or the environment.

4.1 Risk-based oversight in the model

The CFIA will take a:

  1. consistent and structured approach to analysing risks related to different regulated commodities by:
    1. updating risk information on a regular basis to take into consideration any developments in science, experiences in Canada or other countries, or other new information;
    2. making the risk information accessible and transparent; and
    3. applying this approach across all commodities (food, animal, plant, seed, feed and fertilizer); and,
  2. common systematic approach to determining appropriate levels for oversight activities by assessing and re-assessing preventive control plans or relevant equivalents, and the track record of regulated parties (including associated surveillance and recall data, certification to a relevant standard that is recognized by the CFIA, and the regulated party's compliance history). For example, once a regulated party has established a history of compliance with regulatory requirements, the intensity of inspection and/or methods of inspection may be adjusted to correspond with how effectively the regulated party has demonstrated its commitment to effectively mitigate identified risks.

Based on the results of this process, the CFIA will determine the frequency, intensity and type of oversight activities required, and allocate its resources to those areas and regulated parties that present the highest risk to Canadians and Canadian animal and plant populations and the environment. The CFIA will also continue to take into account specific requirements of other countries to facilitate access to export markets.

There are a number of other triggers that could also impact CFIA oversight activities which can be included as elements of a risk management strategy. These include:

4.2 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 risk oversight process, highlighting the information and intelligence sources as well as the analyses used by the CFIA to determine the frequency, extent or type of oversight activities appropriate in a given circumstance.

Numerous sources of information are used as inputs into the determination of commodity risk (e.g., surveillance, research, country evaluations and knowledge of processes and interventions). The analysis of surveillance data generated by the CFIA or recognized external partners provides a useful body of information to support the risk oversight process. In general, surveillance is aimed at demonstrating the absence of a hazard, determining the presence or distribution of a hazard or detecting as early as possible exotic or emerging hazards. The type of surveillance applied depends on the outputs needed to support decision-making. Surveillance information may be derived from active surveillance programs designed to meet specific needs and/or gathered from structured non-random sources as supporting evidence.

Surveillance information is used to support all aspects of CFIA regulatory programs such as, program design, import requirements, export trade, domestic movement as well as pest or disease control and eradication programs.

The determination of commodity risk differs in format and delivery across food, animal and plant programs. It can include both risk assessment and risk ranking. For example, food safety risk assessments are conducted by Health Canada. Animal health, plant health, feed and fertilizer risks are assessed by the CFIA. Risk assessments are conducted according to international standards for risk analysis, as established by the relevant international organizations.

Allocation of CFIA resources related to export certification is also influenced by international requirements for market access. Some regulated commodities are subject to specific oversight requirements for eligibility to export to certain countries. Generally, these considerations flow from foreign country-specific standards for specified commodities.

The CFIA takes the overall risk and market access requirements into consideration to select appropriate frequency, extent or types of oversight activities to achieve desired risk management objectives.

Using this approach, if a trend in non-compliance is observed at a specific regulated party's operation (such as a recurring microbiological issues or imported nursery plants consistently failing to meet import requirements for freedom from pests and diseases), the CFIA could:

The frequency, extent or type of CFIA oversight activities may also be adjusted when:

Practical application of the risk oversight process: The following example illustrates how the risk-based oversight process could be applied to food commodities. The CFIA would group food commodities and preparation processes with similar levels of risk, such as regulated parties who prepare or import ready-to-eat foods for trade (e.g., cheese and chopped salads) that support the growth of pathogens versus regulated parties who prepare or import ready-to-eat foods that are shelf-stable (e.g., honey products and bakery products) and do not support the growth of pathogens.

Other sources of information (as listed in Figure 3) would then be considered jointly with the identified commodity risk to determine overall risk and hence the level of oversight activities appropriate for each regulated party.

Figure 3 – Risk-based oversight process. Description follows.
Figure 3 – Risk-based oversight process

Figure 3 illustrates the factors and criteria that the CFIA considers when conducting 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

  • sources of information for determining risk, with an arrow pointing to
  • determination of risk, with an arrow pointing to
  • information determining overall risk (examples), with an arrow pointing to
  • overall risk
  • Selection of frequency, extent or type of oversight activities (inspection, monitoring, surveillance, etc.)

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

The sources of information for determining risk include

  • Commodity/ commodity type
  • Volume of production/shipment, intended end-use, consumer target groups
  • environmental scanning, forseight and intelligence
  • Knowledge of the process/system/other interventions used to produce, process or market the commodity
  • Hazard identification
  • Monitoring and surveillance data
  • Research
  • Country evaluations
  • Risk assessments by the CFIA, other agencies and countries

Determination of risk include

  • Likelihood of occurrence of biological, chemical and physical hazards in/on/with regulated commodities or travel in/on/with a defined pathway
  • Magnitude of human, animal, plant or environmental health impacts, including economic and social impacts

Information determining overall risk (examples) are

  • Government of Canada Outcome Areas and CFIA Key Priorities
  • Other Risk intelligence (e.g., third party certification / audit, recognition by external standards associations
  • Track records and performance history of regulated party and /or sector (data from oversight activities)
  • Preventive Control Plan (PCP) or equivalent

These would then lead, along with the consideration of market access requirements, to the Selection of frequency, extent or type of oversight activities (inspection, monitoring, surveillance, etc.).

5.0 Overview of inspection


The purpose of the inspection process is to assess whether a regulated party meets regulatory requirements and permission conditions, with or without a PCP. Inspection activities related to a PCP will be organized according to the seven elements of the preventive control plan.

Inspectors will 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.

5.1 Inspection planning and priorities

Inspection activities will be based on risk, compliance data, and capacity and could consider:

There are a number of situations that could cause the CFIA to initiate an inspection. These include but are not limited to:

5.2 Inspection procedures

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

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

There are four basic steps to Inspection:

There are four basic steps to Inspection. Description follows.

Step 1: Preparing for an inspection

Preparation for an inspection will include determining a preliminary scope. Scope can be based on the CFIA plan but may be adjusted for a variety of reasons (e.g. changes in activity, compliance history). Preparation will also include determining whether an inspection will be announced or unannounced, reviewing the applicable Acts, regulations and other reference materials and 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 information, such as physical samples, photographs, and copies of documents or records will also be collected. The process of conducting inspections will include the following activities:

  1. Opening meeting: An opening meeting will introduce CFIA staff and outline the scope of the inspection. It will provide the regulated party with the opportunity to confirm any changes to the company profile and preventive control plan (since last inspection). It will 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 will 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 will be confirmed or amended accordingly.
  4. Completion of inspection: Conducting an inspection will include using traditional inspection and audit techniques (e.g. visual inspection, record review, interviews, sampling, etc.)
  5. Assigning a level of non-compliance: There are three levels of non-compliance that can be used:
    • critical: immediate impact on human, animal or plant health or the environment or repeated serious non-compliance
    • serious: potential impact on human, animal or plant health or the environment
    • technical: non-compliance with regulatory requirements that are not related to human, animal or plant health or the environment
    The table below demonstrates 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
    • records show that a commodity has been processed outside of critical limits (time, temperature or pressure deviations) with no corrective action taken
    • inspector observes cleaning, sanitizing, disinfection operations that generate spray resulting in direct contact with the commodity
    • seed treated with a pest control product is not labelled with the appropriate warning statement
    • premise exports product that does not meet requirements
    • records show that medications have been added to a feed but it is not indicated on the product identification
    • premises is found to be infected with tuberculosis, a regulated animal disease
    • movement of a regulated commodity out of a regulated area without permission
    • condensation is dripping onto food contact surfaces, but no processing or preparation is taking place
    • dead animal is moved without appropriate permit
    • records show that not all measuring instruments are calibrated
    • export of greenhouse plants in used containers
    • lack of segregation of treated forest products from untreated
    • Failure to notify of a suspected pest

    If serious or critical non-compliance is detected, a corrective action request will be issued, indicating which regulatory requirements have not been met. When a regulated plant pest or animal disease is identified, an appropriate notice/order may be issued as per the regulations. Technical non-compliances will be recorded in the inspection report and must be corrected by the regulated party, but a corrective action request does not need to be issued. Technical non-compliances can be enforced by CFIA through graduated enforcement actions, up to and including prosecution.

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

Step 3: Communicating the inspection results

A closing meeting will be held with the regulated party to discuss the outcomes of the inspection, including any incidents of non-compliance, corrective action requests issued and next steps. The inspection report will be shared once complete.

Step 4: Conducting a follow-up inspection:

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

6.0 Imports

The permission requirements proposed in the model apply to importers of regulated commodities. For importers with a licence and preventive control plan, some example strategies can be found in Annex B, Element 1, sub-element 1.3. In some cases, such as a one-time permission, preventive control plans may not be required. However, import conditions will be specified as part of the licensing process.

Products entering Canada must meet regulatory requirements, including those for safety, nutrition, composition, product identification (e.g. tagging or labelling), packaging and quality, and freedom from pests and diseases as applicable.

When dealing with food imports, the CFIA may require importers to provide documentation or information to demonstrate that the commodity is compliant with the legislation. For imports with animal and plant health regulatory requirements, documentation will be required, including the zoosanitary and phytosanitary conditions.

Inspection, surveillance and quarantine of imported commodities are key activities when:

The CFIA would use these activities as tools to identify gaps and trends, to determine sector performance, or to provide baseline information such as the level of chemical contaminants, disease or pests in certain commodities. 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.

6.1 Preventive control plans

Importers do not have direct control over production in other countries and would therefore need to develop other strategies to address risks, including having records to demonstrate how these strategies are effective.

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 commodities would need to address all seven elements of the preventive control plan.

6.2 Inspection

The inspection approach outlined in Section 5 would be used to verify the effectiveness of the importer's preventive control plan.

If an inspector has reasonable grounds to believe that an imported commodity does not comply with import requirements, the CFIA may order that it be removed from Canada or, if removal is impossible, that it be destroyed. In the case of critical and serious non-compliance, the CFIA would take steps to inform stakeholders and the competent authority in the exporting country.

When notified of a non-compliant 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.

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

6.3 Foreign country evaluation

Canada is a significant importing nation. 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.

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

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

Based on risk and available resources, the CFIA may choose to perform on-site foreign country system audits to review the 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.

7.0 Exports

The permission requirements proposed in the model apply to exporters of regulated commodities. Infrequent exporters may be exempt from licensing. For exporters with a licence and preventive control plan, some example strategies can be found in Annex B, Element 1, sub-element 1.4.

Commodities exported from Canada must meet all of the importing country's requirements, including obtaining all required documents.

7.1 Preventive control plans

An exporter's preventive control plan would require export controls to address any foreign regulatory requirements (for example, product identification requirements).

7.2 Inspection

The inspection approach in Section 5 would be used to verify the effectiveness of the exporter's preventive control plan.

7.3 Issuance of export certificates

The model proposes that export certificates be issued based on the exporter's conformance with his or her preventive control plan, and that the certificates could be issued without further lot-by-lot product inspection. 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 commodity inspection and certification of lots to be exported.

If notified by an exporter that a non-compliant commodity had been exported, the CFIA would take appropriate steps to monitor the recovery and control of the non-compliant 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.

8.0 Regulatory Response

The CFIA has a mandate to respond to events that are initiated by lack of compliance on the part of regulated parties and by events that are the responsibility of the Agency to control, such as pest and disease incursions and contaminant events.

The CFIA responds to lack of compliance by regulated parties and is responsible for controlling pest, disease incursions and contaminant events.

This response includes various activities as described in the CFIA's Compliance and Enforcement Policy. The model proposes to apply a single, consistent policy across all commodities that are transparent and appropriate.

For more information, see the Compliance and Enforcement Operational Policy on the CFIA's website.

As the regulatory frameworks are modernized, this policy will be reviewed and updated as required.

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.

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

Specific responses could be directed at the commodity (e.g. quarantine or detention) and/or the regulated party (e.g. issuance of a corrective action request). The inspector has the flexibility to select the appropriate response based on the situation. The range of CFIA regulatory actions can be found in the tools listed in Annex D. Figure 4 - Regulatory Response, illustrates the two streams of the CFIA's regulatory response and how they have the potential to interact with each other. Further detail on the activities within each stream is provided below.

8.1 CFIA response to non-compliance on the part of the regulated party (Figure 4 - Yellow stream)

The compliance and enforcement strategy is based on the principle that the regulated party is responsible for producing safe food, and healthy animals and plants that comply with regulatory requirements. CFIA's response is directed at the regulated party, including those who hold permissions and do not comply with regulatory requirements. The corrective measure must be carried out by the regulated party. The response to non-compliance follows:

Trigger: The CFIA becomes aware of, or conducts an inspection that, establishes non-compliance.

CFIA Response:

A formal request is issued to the regulated party to comply. This could take the form of a corrective action request or inspection report of technical violation.

If there is critical or serious non-compliance, any affected commodity is controlled and the non-compliance is addressed to prevent recurrence.

For example, an importer who has a history of importing non-compliant commodities may be required to submit evidence of compliance before the CFIA would give permission to import. The 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 finding of a non-compliant importation.

The CFIA conducts a follow-up inspection to confirm that effective corrective actions have been implemented and that any changes to a preventive control plan has been documented.

Failure to satisfactorily resolve the non-compliance results in enforcement actions by the CFIA.

8.2 CFIA response to a reportable pest, disease or contaminant event where the CFIA imposes control measures (Figure 4 - Grey stream)

In the case of a regulated animal disease, plant pest incursion or contaminant event in Canada, premises with or without licences may be subject to regulatory control actions to limit the spread as follows:

Trigger: When the CFIA becomes aware of the potential presence of a pest, disease or contaminant, an inspection to confirm its presence is performed. Regulatory control actions may be applied at this stage depending on the level of risk. Confirmatory testing will be performed according to established procedures.

If at any point it is discovered that the producer is in violation of legislation of their own volition, the CFIA will respond with appropriate compliance and enforcement actions. This response is described in 8.1 – CFIA response to non-compliance on the part of the regulated party.

CFIA Response Phase 1: Initial Management

The CFIA determines the scope of regulatory control actions and appropriate response required to contain or remove the contaminant, pest or disease. Control actions may include quarantine, seizure and detention, recall, disposal, etc.

These regulatory response activities continue until:

CFIA Response Phase 2: Long-Term Management

When eradication is not possible or takes several years, the CFIA may order control actions that may include the establishment of regulated areas and movement and production controls. Licences with preventive control plans are required, for example, to demonstrate that the movement of commodities or regulated things will not result in the spread of the disease or pest.

A licence of this type may also be used for international trade out of compartments or recognized special status premises.

The CFIA recognizes that, for many regulated parties, the transition to this integrated inspection model would require time to:

The CFIA understands 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. This would help facilitate transition as regulated parties gather information and interact with the CFIA online and in person (e.g. an online labelling tool, generic model systems). Compliance promotion complements rather than diminishes the CFIA's ability to take enforcement action.

Transitional enforcement guidelines would also be used in the initial stages of implementing the model.

Figure 4 – Regulatory Response. Description follows.
Figure 4 – Regulatory Response

In this Regulatory Response diagram, there are two rows with yellow and grey backgrounds. The yellow row indicates the response when industry is out of compliance while the grey row indicates the response when there is a contaminant/pest/disease event that is out of the control of the industry. These two events may use similar tools to be brought into compliance and both may be occurring at the same time.

Across the top of the diagram, outside the shaded areas, there are 4 boxes with thick arrows pointing down.

The first box is called Regulated Parties and it points to 3 boxes of regulated parties below:

  1. Licence (PCP)
  2. Licence (no PCP)
  3. No licence (PCP)
  4. No licence (no PCP)

The second box and arrow is called Possible Triggers and this box points to 2 boxes below:

  1. Non-compliance (eg. Serious, critical or technical violation)
  2. Contaminant/Plant Pest/Animal Disease – Suspected or detected.

Between the 3 boxes of regulated parties and the two boxes of triggers are arrows that indicate that any regulated party can be impacted by either of the two triggers.

The third box with an arrow pointing down is called CFIA response. This box points to 2 boxes below

  1. Notification to Comply – this box has a small red symbol indicating the CFIA regulatory toolkit which is a small box to one side of the diagram
  2. CFIA orders/ requires regulatory control action (yellow box) – Phase one (short term goal of control or eradication) – this box also has a red symbol indicating the CFIA Regulatory tool Kit.

Between the two trigger boxes is a straight arrow leading to each of the CFIA responses. There is also an arrow from the lower yellow box up to the upper box indicating that a notification to comply can also occur at that stage.

Both boxes have a horizontal arrow pointing to a triangle, which indicates the result of the action in the previous box.

  1. In the top row, the triangle says Industry complies
  2. In the bottom row, the triangle says Contaminant eliminated, Pest/Disease eradiciated

From each of the triangles are two arrows leading to a box containing Yes and No.

The last box at the top with an arrow pointing down is called Outcomes and it points to 4 boxes below:

  1. The box leading from the yes arrow in the first row says compliance (end of process)
  2. The box leading from the no arrow in the first row says Non-compliance and has a red regulatory tool kit symbol (end of process)
  3. The box leading from the yes arrow in the second row says Non-contaminant pest disease state (end of process)
  4. The box leading from the no arrow in the second row says Phase two: pest/disease requires on –going management/movement controls – this box has an arrow leading to the regulated party column and to the Licence (PCP) box.

To one side of the diagram and outside of the shaded area is a dotted box call the CFIA regulatory Tool Kit. This box has a red symbol that is in the boxes, as indicated above. Listed in this box is:

CFIA control actions:

e.g. Seizure and Detention, Quarantine Notices, Movement Controls, Treatment Order, Recall

Enforcement Actions:

e.g. Suspend/Cancel Licence/Permit, AMPS, Prosecution

9.0 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 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 or regulation 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.

10.0 System performance and continuous improvement


As part of inspection modernization, the CFIA is also modernizing its approach to performance measurement. This new approach recognizes not only the scope and complexity of the CFIA's role but also that there are many other participants who play a role in maintaining human, animal and plant health and protection of the environment. All these players influence the ultimate outcome of protecting Canadians and their environment from preventable health risks.

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

The CFIA will enhance the measures being used to demonstrate 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 stakeholders in the system and how the participants work together to prevent, mitigate and manage the risks.

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

The objectives of the performance measurement system are to assess:

to identify:

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

10.1 Systems Performance Framework

To build its approach to measuring system performance, the CFIA developed a Systems Results Model (Figure 5, below) that outlines the relationships between CFIA resources and activities, the key participants who directly influence the system, and the desired outcomes.

The Results Model depicts three levels of assessment 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.

Monitoring and evaluating performance is a CFIA responsibility. To be useful, the number of measures that are tracked and reported by CFIA needs to be limited, highly relevant and exception-based where possible. The CFIA will develop the key performance indicators and targets to check whether policies, procedures and practices that are critical for human, animal and plant health and protection of the environment are successful in achieving 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 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, coordinate 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 human, animal and plant health and protection of the environment. For example:

Figure 5 – The Regulatory Systems Results Model. Description follows.
Figure 5 – The Regulatory Systems Results Model

Figure 5 illustrates three levels of assessment that the CFIA would use to measure the performance of CFIA's sphere of indirect influence.

At the bottom, the first level of system performance (Level 1) identifies activities over which the CFIA has operational spherical control.

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
  • Individuals, Canadians and Consumer associations

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 and plant and animal resource base where risks to the supply 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.

10.2 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.

A variety of sources of data will need to be incorporated into the assessment process to reflect the complex system, the numerous players involved and the wide scope of CFIA responsibilities. Assessments would be focussed both internally and externally and be either continuous or periodic. Assessment results would be used for

As part of embedding a continuous improvement in its philosophy, the CFIA is improving and strengthening Canada's inspection system by establishing inspection system verifiers to oversee the performance of Canada's entire inspection system. Among other activities, the inspection system verifiers will conduct in-depth reviews of plans in the regulated party's operations to:

Examples of current performance assessment tools available:

  1. Field Observation – assess internal performance to identify gaps and issues in the effectiveness and quality of service delivery and in national consistency, the level of understanding of responsibilities, and the appropriate identification of non-compliance.
  2. Quality Management – assesses internal performance by tracking compliance with internal protocols, service standards and expectations.
  3. Audit – as per the Treasury Board Policy on Internal Audit, conduct periodic internal audits regarding the governance, risk management and controls in place for effective management practices and accountability.
  4. Evaluation – as per the Treasury Board Policy on Evaluation, conduct internal evaluations regarding the relevance and performance of programs, initiatives and policies.
  5. Surveys – assess internal and external performance by seeking input from CFIA staff, regulated parties and other system stakeholders on the function and quality of the system, the information and tools provided and suggestions for improvement.

11.0 Transparency

The safety of food, animal and plant health is important to all concerned, from producers to consumers. Consumer confidence depends, in part, on their perception of the effectiveness of the inspection system.

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 human, animal and plant health impact of the CFIA's activities and will promote confidence.

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 making licence/permit suspensions and cancellations available to the public to enable consumers to make informed buying choices.

In examining approaches used by other nations with strong regulatory systems, the CFIA has observed that governments are moving to

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

Annex A: Permissions processes

The following provides additional information on the approach for permissions.

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

In order to obtain a licence, an applicant must

An applicant for a licence will be required to attest to having implemented a preventive control plan (if required) that is commensurate to the nature of his or her operations and meets the criteria set out in Section 3 and Annex B as applicable.

Applying for / obtaining a permission

Applicants for a permission must submit the following information to the CFIA:

  1. Application status (applicant checks the option that applies)
    1. new
    2. amendment
    3. renewal
  2. Contact and legal information (all relevant 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
      • GPS location, if needed, to ensure accurate site/field/animal identification
      • Provincial Premises ID
    • mailing address (if different from legal address)
    • address where records will be available (if different from legal address)
    • fax/telephone number, email address, website (if available)
    • name of operator (licence holder)
    • name of primary contact person at each physical location
    • name of emergency contact
  3. Business activities information (applicants must check all that apply)
    1. import
    2. export (e.g. facility prepares regulated articles, including food, for export)
    3. operate domestically, such as
      1. interprovincial businesses (e.g. food preparation)
      2. regulated areas (e.g. to control animal disease and plant pests)
      3. high risk facilities (e.g. plant auctions and animal auction yards, research and quarantine facilities, medicated feed manufacturers)
  4. Sub-activities:
    1. without storage / distribution premises
    2. with storage / distribution premises
    3. involved in preparation (includes to grow, process, treat, preserve, handle, test, grade, code, collect, hatch or slaughter or to do any other activity in respect of it that is prescribed)
    4. operations not falling within one of the above categories
  5. Country(ies) of origin or destination if applicable
  6. Operational information:
    • Business status (applicants must check the option(s) that applies)
      1. active
      2. inactive
      3. seasonal (Note: If the business is a seasonal operation, the applicant will be required to notify the CFIA of the planned start and end date for operations and the hours and days of operation for each site)
    • Hours
      • hours of operation
      • days of operation
    • Business size
      • number of employees working in each establishment (ranges will be provided as options)
      • estimates of annual volume of production / number or importations or exportations of commodities (ranges will be provided as options)
  7. Commodity information for each activity covered by the individual licence must be described (e.g. slaughter, food manufacturing, feed manufacturing, mobile artificial insemination).


    1. Alcoholic beverages
    2. Non-alcoholic beverages
    3. Confectionary, sweeteners, snack foods (containing or not containing nuts), desserts
    4. Dairy
    5. Eggs and egg products
    6. Fats and oils
    7. Fish and seafood
    8. Food chemicals (for example, additives, processing aids)
    9. Fruit and vegetables
    10. Grain-derived foods (for example breakfast cereal, bread and bakery, pasta)
    11. Honey
    12. Infant foods
    13. Maple products
    14. Meat and poultry
    15. Multiple/mixed foods (for example, pizza, frozen meals, sandwiches)
    16. Nuts, grains, seeds
    17. Spices, herbs, flavours, condiments, dressings
    18. Other


    1. Live animal(s)
    2. Semen
    3. Embryo(s)
    4. Aquatic germplasm
    5. Animal products and by-products (including Pet Food)
    6. Veterinary pathogens
    7. Veterinary biologics
    8. Animal feed
    9. Animal transporters
    10. other


    1. Grains and field crops
    2. Potatoes
    3. Forest products, with or without bark
    4. Horticultural products
    5. Plant pests and pathogens
    6. Fertilizers and supplements
    7. Seeds
    8. Plants with novel traits
    9. other (including soil, growing media and packaging materials)
  8. Commodity description (include purpose, form, end-use, quantity, scientific and commercial name) (applicants will check all that apply)


    1. ready-to-eat
    2. not ready-to-eat
    3. prepackaged foods
    4. foods for packaging, labelling, re-labelling
    5. foods for research/testing
    6. other

    Animals (terrestrial and aquatic), Animal Products and by-products, Vet Biologics and Pathogens

    the following are possible end uses or activities that would be important to determine the risk

    the choices available will be based upon the commodity selected above; not all choices listed below will be available for every animal commodity listed above

    1. breeding
    2. technical use (e.g. photo gelatin)
    3. production (e.g. vaccine manufacturing)
    4. feeding
    5. research/education/testing facility
    6. competition/exhibition
    7. processing
    8. slaughter
    9. retail sale
    10. owner's use
    11. transporting
    12. intermediary (e.g. sales barns, pet food)
    13. disease control
    14. quarantine
    15. other (e.g. cervid movement, zoos, in transit)


    1. manufacturing
      • ingredient
      • mixed feed
      • on farm (non-commercial)
    2. retail sale
    3. conveyance
    4. research/education/testing facility
    5. other


    1. manufacturing
    2. plants for planting
      • in vitro
      • cuttings
      • bare rooted
      • in soil
      • seed
    3. research/education/testing facility
    4. exhibition
    5. retail sale
    6. finished products/packaging (e.g. pallets, packing material and Christmas ornaments)
    7. owner's use
    8. quarantine facility
    9. other


    1. propagation
    2. conditioning
    3. bulk storage
    4. research/education/testing facility
    5. other


    1. manufacturer
    2. blender
    3. research/education/testing facility
    4. other

Amendments and renewals

For amendments and renewals, the licence holder will access his or her unique account in the CFIA web portal; select the desired activity (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 application, the Minister (or delegate) will review the information provided and request additional information if required.
  2. A pre-licensing inspection may be required for high-risk activities.
  3. The Minister (or delegate) will review the facts before rendering a decision. If required, expert advice would be sought to ensure that the licensing criteria are applied consistently.
  4. The Minister (or delegate) may refuse to issue a licence if the applicant
    • does not meet licensing conditions
    • has submitted inaccurate information
    • has provided false or misleading information, documents or records
    • engaged in deceptive practices in order to obtain a licence

Step 2: Communication of decision

  1. Notification will be sent if a pre-licensing inspection is required.
  2. If a licence is refused, a written notice of refusal will be sent, with the reasons for the refusal.
  3. The applicant will be able to 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 will be available to regulated parties following a decision to refuse to issue a licence.

Process for suspending a licence

Step 1: Initiation

  1. If a CFIA inspector identifies a non-compliance as per Section 2 (Suspension of a licence), the suspension process will be initiated.
  2. The inspector will identify any non-compliance(s) and gather facts to support the finding(s).
  3. The inspector will inform CFIA management of the facts of the non-compliance.
  4. The licence holder will receive a report of the inspection and will be provided with an opportunity to remedy the non-compliance.

Step 2: Evaluation

  1. If the non-compliance is not addressed, the licence will be suspended. The Minister (or delegate) will review the findings and if required, seek expert advice, to ensure that the suspension criteria are being applied consistently.
  2. The Minister (or delegate) will render a decision concerning suspension of the licence in question.

Step 3: Communication of decision

  1. If the licence is suspended, the licence holder will receive a written notice of the suspension, and the reasons for it.

Step 4: Lifting of a suspension

  1. In order to have a suspended licence re-instated, the licence holder must submit a written plan to address the issues that resulted in suspension of the licence.
  2. The CFIA inspector will follow up to determine whether the issues indicated in the suspension have been addressed.
  3. If the issues are adequately addressed, the inspector will report the findings and close the file. Additional conditions may be imposed on the licence by the Minister (or delegate).
  4. If the issues are not resolved, the CFIA will initiate cancellation of the licence (see below).

Process for cancelling a licence

Step 1: Initiation

  1. If the inspector identifies unresolved issues as per Section 2 (Cancellation of a permission), the cancellation process is initiated.

Step 2: Evaluation

  1. The Minister (or delegate) will review the inspector's recommendation and the Agency's file to verify that the cancellation criteria are being applied consistently.
  2. A permission 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). 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) will consider the submissions of the CFIA and the permission holder and render the decision with reasons for the decision.

Step 3: Communication of decision

The permission holder will receive written notification of the decision. If the permission were to be cancelled or suspended, the notification will include the reason for the decision.

Annex B: Elements of the preventive control plan

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: Process and product control outcomes and performance criteria

Expected Outcomes

1. Process and product controls contribute to the production of compliant commodities

  • 1.1 Process control outcome

    The process is controlled to achieve regulatory compliance.

  • 1.2 Product control outcome

    Finished products meet regulatory requirements including appropriate packaging and product identification.

  • 1.3 Import control outcome

    Imported commodities meet regulatory requirements.

  • 1.4 Export control outcome

    Exported commodities 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 Process control outcome: performance criteria

  1. Incoming inputs (for example, ingredients, raw materials, plants and animals)
    • identification of incoming inputs and their source (for example, the immediate supplier)
    • identification of incoming inputs, with written specifications, if
      • there is a potential hazard
      • an input is critical to biosecurity, product composition, health status and/or nutrition profile
    • documented handling procedures for inputs to prevent hazard introduction, and contamination and maintain integrity
  2. Product formulation and specifications
    • written formula for each product that is being prepared
    • written specifications for each final product
    • additives and chemicals (including medicating ingredients, drugs and vaccines) used are permitted in and on the commodity
  3. Processing
    • written description of
      • processing steps (for example, mixing records), associated control measures and critical limits
      • commodity movement (for example, process flow diagram)
      • commodity changeover procedures
  4. critical limits are validated using scientific data


  • Inadequate input controls could result in non-compliance (for example, product contamination, inadequate processing, misrepresentation of the product, infestation, unapproved propagation, residues, etc.).
  • Inaccurate product formulation and/or mixing could result in non-compliance (for example, product adulteration, inadequate processing, drug or pesticide residues, etc.).
  • Inadequate process controls could lead to pathogenic organisms, toxins, pests, disease, undeclared allergens and other hazards.

1.2 Product control outcome: performance criteria

  1. Packaging
    • There is a written specification for packaging materials that come in contact with commodities.
    • All packaging materials are suitable for the intended use.
  2. Product identification
    • The information is complete, truthful and not misleading. It also accurately represents the commodity and its content, and meets regulatory requirements.
  3. Finished Product
    • The finished product is evaluated for compliance with regulatory requirements.
    • Outgoing commodities and their destination are identified, including those destined for export (for example, the immediate purchaser is identified).


Inadequate commodity controls could result in

  • the use of packaging that may contaminate or permit contamination of the commodity and/or the environment,
  • inaccurate and/or incomplete information on product identification,
  • 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 Import control outcome: performance criteria


Importers do not have direct control of the preparation of the 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


Commodities for export may contain inputs that are not permitted in Canada. Segregation would prevent the 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

  1. Incoming inputs (for example, ingredients, raw materials, plants and animals)
    • Verify that traceability records are accurate and maintained.
    • Review records to determine if there is potential for any incoming inputs to contain hazards. Adjust the scope of the inspection, if necessary.
    • Check whether inputs that could contain hazards are properly identified and segregated.
    • Observe how inputs are received to verify that there is no cross-contamination and integrity is maintained.
  2. Product formulation and specification
    • Review the types of products prepared and adjust the scope of the inspection to incorporate higher-risk processes.
    • Confirm that the current formula is available and documented for each product.
      • Assess any changes to product composition for any impact on product identification accuracy and safety.
    • Confirm that additives, drugs, chemicals and medicated ingredients are permitted for use in and on the commodity.
  3. Processing
    • Select a product that is being processed at the time of inspection, and follow it through the processing steps to confirm that
      • the product formulation matches the recipe (written specifications) and note any product substitutions and appropriate adjustments to processing or product identification.
      • inputs are accurately measured and blended, and
      • processing controls are monitored and critical limits/tolerances are met.
    • Review process validation records to confirm that processes and parameters are current.
    • Observe product and process flow for potential cross-contamination.
    • Observe that procedures are being followed for the use of rework and product changeover and that there is no cross-contamination.

Inspection activities for sub-element 1.2: Product controls

  1. Packaging
    • Confirm packaging material meets the regulatory requirements.
    • Observe the packaging process to verify that contaminated, damaged or defective packaging material is not used, and that the commodity is not damaged or contaminated, nor is there a potential to contaminate other commodities or the environment.
  2. Product identification
    • Select a commodity or commodities to verify that product identification accurately represents content and meets regulatory requirements. For example:
      • foods commodities containing priority allergens are labelled;
      • nutrition labelling requirements are met;
      • all nutrition claims are factual, not false and not misleading; and
      • any other product identification requirements are met, including mandatory information (such as heat treatment of wood, type size, bilingual requirements, net quantity declarations, ingredient declarations, health or product claims).
  3. Finished product
    • Review sampling and testing results to see if any deviations are noted and, if so, review their associated corrective actions.
      • take samples of final product, if necessary/required, to confirm compliance with regulatory requirements.
    • Verify that traceability records are accurate and maintained.

Inspection activities for sub-element 1.3: Import controls

Inspection activities for sub-element 1.4: Export controls

Element 2: Sanitation, biosecurity, biocontainment, pest control and chemicals outcomes and performance criteria

Expected outcomes

  • 2.1 Sanitation, biosecurity and biocontainment
    • An effective sanitation program for equipment and premises is in place to prevent contamination of the commodity
    • An effective biosecurity and biocontainment program is in place to prevent the introduction, establishment or spread of pests and/or disease.
  • 2.2 Pest Control
    • An effective control program for pests, including vectors, is in place to prevent entry, to detect and eliminate pests and to prevent contamination of the commodity.
  • 2.3 Chemicals
    • Chemicals are stored and used in a manner and under conditions that do not impact negatively on human, animal or plant health or the environment.

The following performance criteria would have to be addressed by the regulated party to achieve the sanitation, biosecurity, biocontainment, pest control and chemical outcomes.

2.1 Sanitation, biosecurity and biocontainment outcome: performance criteria


Improper or inadequate biosecurity, biocontainment and/or sanitation, activities can lead to contamination of commodities, premises, packaging materials and contact surfaces or the spread of diseases and pests.

2.2 Pest control outcome: performance criteria


Pests, including vectors, (for example, insects, rodents and birds) can contaminate commodities, or contaminate or infect animals or infest plants, inputs, packaging materials and contact surfaces. Pests in or around premises can lead to commodity contamination, infection of animals or infestation of plants (for example, from droppings, larvae, and insects or animals).

2.3 Chemicals outcome: performance criteria


  • 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, rinse chemicals in excess of approved concentration) and biological contamination (for example pest or pathogens not effectively removed).
  • Improperly stored chemicals can lead to contamination or harm to humans, animals, plants, or the environment.

Element 2: Inspection activities for sanitation, biosecurity, biocontainment, pest control and chemicals

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: Sanitation, biosecurity and biocontainment

Inspection activities for sub-element 2.2: Pest control

Inspection activities for sub-element 2.3: Chemicals

Element 3: Hygiene, biosecurity and employee training outcomes and performance criteria

Expected outcomes

  • 3.1 Hygiene and biosecurity

    Employees and visitors are not a source of contamination.

  • 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 human, animal or plant health, the environment 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 Hygiene and biosecurity outcome: performance criteria


  • Employee training and hygiene contribute to the production of safe, healthy commodities and effective biosecurity practices.
  • Employees and visitors who do not follow hygienic and biosecurity practices can cause contamination or spread pests/diseases.

3.2 Employee training outcome: performance criteria


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 and biosecurity

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 commodities or 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.


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

Element 4: Inspection activities for equipment design and maintenance

Element 5: Physical structure, surroundings and maintenance outcomes and performance criteria

Expected outcomes

  • 5.1 Premises and surroundings

    Conditions of the premises and surroundings do not contribute to contamination, infection or infestation of regulated commodities.

  • 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 comes into contact with regulated commodities is safe for its intended use.

  • 5.4 Waste disposal

    Effluent and waste storage and disposal systems are designed, constructed and maintained to prevent contamination of regulated commodities, and the environment.

The following performance criteria would have to be addressed by the regulated party to achieve the physical structure, surroundings and maintenance outcomes.

5.1 premises and surroundings outcome: performance criteria


Outside sources of contamination can compromise the safety, health and/or quality of the commodity.

5.2 Buildings outcome: performance criteria

a. Exterior building structures


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

b. Interior building structures


  • 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 commodities, ingredients, packaging materials and contact surfaces.

c. Hygienic flow and separation


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

d. Lighting


  • If lighting levels are inadequate, employees may not be able to properly carry out the activities (including processing, quality control, reading of critical instrumentation, cleaning, sanitizing as well as inspecting for pests and diseases).
  • If a light bulb or lighting fixture breaks over exposed commodities, ingredients, packaging materials or contact surfaces, it presents a potential physical hazard.

e. Ventilation


  • Adequate ventilation minimizes condensation which could contaminate commodities.
  • 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.
  • For livestock barns, ventilation is important to support herd health and animal welfare.

f. Employee facilities


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

5.3 Water, ice and steam outcome: performance criteria

a. Water, ice and steam safety


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 intended use.

b. Water, ice and steam handling equipment


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

5.4 Waste disposal outcome: performance criteria


  • An effective waste removal and disposal system will reduce pest harbourage and the risk of contamination of the environment, or cross-contamination of commodities, inputs, packaging material, 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, surroundings and maintenance

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: 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 outcomes

  • 6.1 Receiving, transportation and storage

    If applicable, commodities (including inputs) and packaging materials are transported, received and stored in conditions that maintains integrity and prevents damage, spoilage, propagation and contamination.

  • 6.2 Animal transportation

    Animals are transported humanely, in accordance with regulatory requirements.

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

6.1 Receiving, transportation and storage: performance criteria


  • 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 commodities that require temperature and humidity control can be impacted negatively if left at ambient or adverse temperatures and conditions for prolonged periods.

6.2 Animal transportation: performance criteria


Animals may be injured or may not reach their destination in a suitable condition, unless they are transported and handled humanely.

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.

Inspection activities for sub-element 6.1: Receiving, transportation and storage

Inspection activities for sub-element 6.2: Animal transportation

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

Expected Outcomes

  • 7.1 Traceability and recalls
    • Commodities are adequately identified to enable removal from the marketplace or other movement restrictions.
    • Non-compliant commodities are effectively prevented from entering into commerce and can be rapidly retrieved if distributed, controlled and disposed of, as appropriate.
  • 7.2 Complaints
    • Complaints related to diseases, pests, safety, product misrepresentation and animal transport 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 Traceability and recall outcomes: performance criteria


Identifying and controlling implicated commodities quickly and effectively is crucial for protecting consumers, plants, animals and the environment from preventable risks.

7.2 Complaints outcome: performance criteria


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, control and mitigate 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 steps for the inspection of the licence holders' preventive control plans

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 integrated Agency Inspection Model. Outcomes and performance criteria against which inspectors verify compliance can be found in Annex B.

Step 1: Prepare for the inspection

  1. Determine preliminary scope of inspection.
    • Once a facility has been identified for inspection, the scope of the inspection may be adjusted in response to:
      1. changes in activity (e.g. operation has begun exporting),
      2. triggers (e.g. recalls, complaints, clinical signs),
      3. company records, previous inspection reports and compliance history (e.g. repeated non-compliance),
      4. any element of the preventive control plan that is a priority (e.g. Element 1: Process and product control), and
      5. other elements that are not covered by a previous inspection.

    With time, the regulated party's entire system should be inspected to verify compliance with all regulatory requirements.

  2. 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.

    • announced inspections provide inspectors with the opportunity to make arrangements with the operator and key personnel for interviews and to obtain a commitment that relevant documentation will be available.
    • unannounced inspections provide the opportunity to view operations as they are performed. This may limit the scope of the inspection if certain personnel are not on site or certain activities are not being conducted.
  3. Review the applicable Acts and regulations, other reference documents and other applicable sources of information.
  4. Gather inspection documents (e.g. relevant regulations, procedure manuals) 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 information, such as physical samples, photographs and copies of documents may also be gathered.

  1. Opening meeting
    • introduce all CFIA staff present and explain each person's role;
    • outline the scope of the inspection, the process to be used, the estimated amount of time required and the date and time of the closing meeting;
    • identify any staff or resources required to support conducting the inspection and confirm the key contact;
    • update the regulated party on any changes to the inspection process and/or relevant regulations;
    • confirm any changes to the information in the company profile;
    • confirm any changes to the preventive control plan or deviations since the last inspection and modify the scope of the inspection, if necessary;
    • confirm the status of any unresolved CARs,
    • confirm the operation's security and safety requirements (e.g. hygienic measures, people flow restrictions, protective equipment, etc.);
    • indicate that the operation will be advised of any changes to the scope during the inspection; and
    • for inspections longer than one day, advise that an end-of-day meeting may be conducted to notify of any non-compliance(s) that may have been observed.
  2. 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 premises profile.

    • Observe the general conditions of the premises (including conditions both outside and inside).
    • Focus efforts on identifying potential sources of contamination, infestation or infection that require further consideration.
    • Conduct the flow of the walk-through in a manner that does not introduce hazards.

    When outside the facility, observe the general cleanliness of the surrounding area and any conditions that could contribute to contamination, infestation or infection.


    • harbourage of pests
    • environmental contaminants
    • uncontrolled access points to preparation areas
    • deterioration in condition of facilities (e.g. buildings, and external structures such as fences) that would permit entry of pests or other potential sources of contamination

    When inside the premises, observe the general cleanliness and any conditions that could contribute to contamination, infestation or infection.


    • conditions of floors, walls, ceilings (e.g. clean, in a good state of repair)
    • employee hygiene, biosecurity and biocontainment practices
    • evidence of pest activity
    • lighting (e.g. protective shields in food or feed handling processing areas, none broken)
    • ventilation (e.g. odours that are not characteristic of the process or commodity, visible condensation)
    • waste management (liquid and solid)

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

  3. Confirm the scope of inspection

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

  4. 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 long term performance. Focus on records for commodities that will be prepared during the inspection so that employee actions can be observed and on-site interviews conducted.

    Address the following for each element examined:

    • the responsible employee(s)
    • the outcome
    • the control measures
    • the monitoring procedures for each control
    • any corrective actions for deviations
    • the verification activities
    • the required records

    Review monitoring records to determine if:

    • control activities are performed as specified (e.g. equipment calibration, processing times, temperature checks, sanitation checks)
    • the controls are met
    • deviations are identified and appropriate actions are taken

    Review verification records to determine if:

    • monitoring activities are performed as specified
    • the operation's control measures are effective
    • deviations are identified and appropriate actions are taken

    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 (e.g. 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 commodity or swabs of the equipment and/or the environment to verify inspection observations and to help determine whether the regulated party is compliant. Send any samples collected to the appropriate 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 — 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:

    • What are you doing and/or recording?
    • What is the purpose of what you are doing?
    • How does it help to confirm that the control is effective?
    • What do you do when there is a deviation?

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

  5. Assign a level of non-compliance

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

    There are three levels of non-compliance:

    • critical: immediate impact on human, animal or plant health or the environment or repeated serious non-compliance
    • serious: potential impact on human, animal or plant health or the environment
    • technical: non-compliance with regulatory requirements that are not related to human, animal or plant health or the environment

    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 the 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 non-compliance with impact on human, animal or plant health, or environment issues are observed, take the following steps:

    • Communicate and discuss the issue with the regulated party's key contact to determine if further action is required.
    • If further action is required, request immediate action to control the affected commodity and correct the issue.
      • Determine if the entire affected commodity is under control.
      • Initiate compliance or enforcement action (e.g. seize and detain product, stop production, initiate recall) if the commodity is not effectively controlled.
  6. 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:

    • information that identifies the specific records assessed
    • date of record

    Documentation of observations and interviews includes the following:

    • name, title and area of responsibility of personnel interviewed and/or observed
    • area of the facility/procedure observed
    • description of any non-compliance observed

    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 complete.

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 properly 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 (e.g. suspension of licence, product seizure and detention) Take immediate action to control the affected commodity, if necessary, and address the non-compliance to prevent recurrence
For a serious non-compliance Elevates to a critical corrective action request Take immediate action to control the affected commodity, if necessary, and address the non-compliance to prevent recurrence
For a technical non-compliance Initiates appropriate enforcement action (e.g. AMPs, product seizure and detention) Correct the non-compliance

Annex D: Range of Regulatory Actions

The following is a list of the CFIA's possible regulatory actions, whether due to activities on the part of regulated parties or due to events involving contaminants or disease/pest incursions. They are not listed in order of magnitude and it is not a comprehensive list. More than one response may be used in any given situation.

  1. Inspection

    An assessment and verification that a regulated party meets the requirement of the Acts and regulations administered or enforced by the CFIA. For example, a consumer or industry complaint could trigger an inspection.

  2. 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 commodity did not comply with other federal legislative requirements or the requirements of the importing country.

  3. Start or stop activities

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

  4. 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 Acts or the regulations administered or enforced by the CFIA. For example, a commodity can be seized and detained until

    • the commodity is brought into compliance,
    • the court or AMP proceedings are complete, or
    • it is ordered returned by the Court or the Tribunal.
  5. Removal from Canada

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

  6. Quarantine/Movement Controls

    The declaration of infected place, the notice of infested place and movement controls are used to contain regulated pests or diseases.

  7. Corrective action request

    A corrective action request (CAR) is issued by the CFIA to a regulated party in cases of serious or critical non-compliance. The CAR requires the regulated party to implement corrective measures within a defined timeframe.

  8. Meeting with the regulated party

    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.

  9. Notice of non-compliance

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

  10. Publication of non-compliance

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

  11. Disposal/Destruction

    A commodity (or anything) that violates the Acts and regulations administered or enforced by the CFIA may be ordered destroyed or disposed in accordance with the applicable Acts and regulations.

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

  12. Injunction

    Currently, on application by the Attorney General, the court may issue an interim or permanent injunction ordering a person to stop doing an activity that may be in violation of the Acts and regulations administered or enforced by the CFIA, or start an activity to prevent the commission of an offence. Under section 18 of the Canadian Food Inspection Agency Act, the CFIA may apply to a court of competent jurisdiction for an interim injunction. Once the Safe Food for Canadians Act is fully in force, the Minister will be able to apply for a permanent injunction.

  13. Recall

    Recalling a product would be appropriate when there are reasonable grounds to believe the regulated product poses a risk to the human, animal or plant health or the environment. 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."

  14. 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 Section 2 (Permissions) for a list of grounds and more details.

    Furthermore, the Minister may make a licence subject to any additional conditions considered appropriate.

  15. Administrative Monetary Penalties

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

    • AMPs allow for alternative actions to be taken to encourage compliance with requirements, without having to immediately resort to the suspending or cancelling of licences or to instituting proceedings;
    • AMPs provide an avenue other than the penalties section of an Act for encouraging compliance with requirements;
    • AMPs allow for regulated parties to request a review of the facts by the Canada Agricultural Review Tribunal, or to the Minister; and
    • AMPs can take the form of either a notice of violation with a warning, or a notice of violation with a penalty determined in accordance with the AAAMPA.

    The Health of Animals Act and the Plant Protection Act currently contain provisions for AMPs. Monetary penalties may be issued in respect of the scheduled violations specified under the animal and plant health legislative authorities.

    Under the SFCA, the CFIA will have the authority to adopt AMPs as an enforcement tool for food commodities. AMPs are under consideration for commodities to which the legislation does not currently apply.

  16. 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.

  17. Treatment order

    The CFIA can order the treatment of a commodity to mitigate the risk of a pest or disease.

  18. Vaccination

    Vaccination of animals can be used as a means to prevent the spread of disease.

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 Complaints and Appeals Office (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:

  1. Existing Process – when the CAO determines there is already an existing mechanism to deal with the complaint. Examples include:
    • an appeal of a compensation decision under the Health of Animals Act or Plant Protection Act,
    • a request for re-inspection under the Fish Inspection Regulations,
    • an appeal of decisions made under the Agriculture and Agri-Food Administrative Monetary Penalties Act,
    • a food complaint from a consumer (food safety or non-food safety),
    • dissatisfaction with a Board of Arbitration decision for fresh fruit and vegetables,
    • a trade complaint made by industry or a competitor.
  2. No review – when the CAO determines that it 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.
  3. 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 and detention, product identification 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 there is 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.


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 law respecting access to information and privacy will be respected.

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: Glossary of Terms

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

Any person who applies for permission.
Application of measures and procedures implemented to prevent the spread and release of pests, diseases and contaminants from a site.
A set of practices used to minimize the transmission of pests, diseases and contaminants including their introduction (bioexclusion), spread within populations (biomanagement), and release (biocontainment).
Written assurance from a competent authority that commodities or preventive control plan systems conform to requirements.
Refers to the frequency and volume of activities conducted by business and industry for trade.
Any product and/or thing regulated under any Act or regulations administered or enforced by the CFIA.
Competent authority
A government agency or department having jurisdiction to perform a regulatory or enforcement function or both.
Any biological, physical, chemical agent or other substance that is present in a regulated commodity and that compromises human, animal or plant health or the environment.
Control measure
Any action or activity that can be used to prevent, control or eliminate a hazard or mitigate the risk.
Corrective action
The steps that a regulated party takes to address non-compliance, which can include controlling affected product, conducting root cause analysis and modifying procedures to prevent recurrence.
Corrective action request (CAR)
A document issued by the CFIA to a regulated party in cases of serious or critical non-compliance. The corrective action request describes the non-compliance and requires the regulated party to take corrective actions.
Critical non-compliance
Immediate impact on human, animal or plant health or the environment or repeated serious non-compliance.
A situation that occurs when hazards are transferred from one commodity, input, or surface to another.
A person, including a wholesaler, who distributes commodities or other regulated materials.
Distribution centre
A warehouse or other specialized building that is stocked with commodities or things to be redistributed to retailers, wholesalers or directly to consumers.
A person who is conducting activities for and/or on behalf of an establishment or a premises.
Any place, including a conveyance, where a commodity is produced/manufactured, prepared, stored, transported, packaged or identified (including labelling).
Any person who prepares or sells or trades commodities from Canada to another country.
Exposure assessment
The qualitative and/or quantitative evaluation of the likely intake of or exposure to biological, chemical or physical hazard by humans, animals, plants or the environment.
Food grade materials
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.
Hazard – Biological
Any illness- or disease-causing pathogen, micro-organism, pest or vector that poses a danger to human, animal or plant health or the environment.
Hazard – Chemical
A chemical substance that poses a danger to human, animal or plant health or the environment.
Hazard – Physical
Any foreign materials that are not normally found in a commodity and that pose a danger to human, animal or plant health or the environment.
Any person in Canada who imports commodities into Canada.
Any incoming materials used to prepare, process, or produce regulated commodities.
Formal permission from the regulatory authority to conduct a regulated activity.
The act of conducting a planned sequence of observations or measurements of control parameters to assess whether a control measure is under control.
Not ready-to-eat food
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.
Objective evidence
Information directly collected by an inspector through observation, measurement, testing or other means.
Activities designed to determine whether a regulated party is complying with Acts and regulations administered or enforced by the CFIA and whether regulated commodities meet regulatory requirements.
A formal consent granting legal authorization to a regulated party.
Any species, strain or biotype of organism injurious to or impacting on human, animal or plant health or the environment (including prions).
A geographically defined location that includes lands, establishments, buildings and facilities (for example, greenhouses, corrals, assembly or auction yards).
Prepare or Produce
Includes to grow, process, treat, preserve, handle, test, grade, code, collect, hatch or slaughter or to do any other activity in respect of the regulated commodity.
Preventive control plan
A combination of control measures that, when taken as a whole, provide for a science-based approach to managing risks posed by hazards and contribute to achieving compliance with regulatory requirements.
Primary producer
A person who grows, raises, or harvests agricultural or forestry products or animals.
Product identification
Any document or device associated with and/or attached to a product that allows the CFIA to distinguish that product from another (such as labels, tags, tattoos, stamps, microchips).
Ready-to-eat food
  1. do not require any further preparation or cooking 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. are ordinarily consumed in the same state as that in which they are sold.
Regulated Area
A designated area (e.g. compartments and zones) subject to regulatory control.
Regulated party
A person (including an individual, corporation, partnership or organization) who is subject to the Acts and regulations administered by the CFIA.
Representative sample
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.
Risk-based inspection
A method, using risk factors, to prioritize and manage inspection activities.
Risk characterization
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.
Cleanliness appropriate to the operations of the regulated party.
Serious non-compliance
Potential impact on human, animal or plant health or the environment
A process which collects records and analyzes data systematically to inform regulatory decision making and influence actions to be taken.
Systems-based approach
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 commodity production or preparation.
Obtaining evidence that a control measure or combination of control measures, if properly implemented, is capable of controlling the hazard to a specified outcome.
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.
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.
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