Integrated Agency Inspection Model - Final Version
February 11, 2015

Overview

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

  • founded on science and based on risk, and that use common inspection procedures and tools;
  • aligned with international standards, such as those developed by Codex Alimentarius Commission (Codex), the International Plant Protection Convention (IPPC), and the World Organisation for Animal Health (OIE);
  • based on the premise that industry is responsible for its products and processes and must demonstrate ongoing compliance with legislative requirements;
  • flexible, to accommodate the complexity and size of an operation; and
  • supported by information management / information technology (IM/IT) solutions that will facilitate planning, reporting and decision making.

The integrated Agency Inspection Model replaces the improved food inspection model to fully align the strategic outcomes for all CFIA inspection work and reflect the full Agency mandate.

The model represents the CFIA's vision and its approach to regulatory inspection.

The integrated Agency Inspection Model is not a stand-alone initiative. 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.

The integrated Agency Inspection Model replaces the improved food inspection model.

Figure 1 – CFIA Functions and the model components. Description follows.
Description for 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 is one box that represents the inspectors required to deliver the new model.
  • The nine circles around the pentagon represent the various business functions 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.

Pentagon

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

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

The box at the center of the pentagon is titled "Inspectorate".

Circles

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
  8. Enforcement
  9. Redress of complaints and appeals

Rectangular Base

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

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

The CFIA will be phasing the model into operation starting in 2013 and continuing through 2020. More information about implementation will be provided to stakeholders as it progresses.

Guide for navigating the document

Section 2 and Annex A outline the conditions and processes around the granting of permissions. This key component of the model identifies and authorizes a regulated party to conduct an activity.

Section 3 and Annex B provide details on the proposed elements of preventive control plans (PCPs) and the expected outcomes and performance criteria. A key requirement of the permission regime is the condition that permission holders develop, implement and maintain effective PCPs suitable to the size and complexity of their operations. CFIA staff will be guided by the inspection activities described in Annexes B and C to assess how effectively a permission holder's PCP demonstrates regulatory compliance.

Section 4 provides information about CFIA oversight which is based on the three elements of risk analysis: risk assessment, risk management and risk communication. The section also highlights the responsibility of regulated parties in risk management. Examples are given of the types of information the CFIA will consider when determining the level of oversight. The type, frequency and intensity of the CFIA's oversight activities will be proportional to the risks (including health, economic, social, consumer protection and other types of risks).

Section 5 and Annex C provide an overview of inspection and the general procedures inspectors will follow when conducting an 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 will need strategies to meet the foreign country's regulatory requirements. In both cases, the Product and Process Control element of the PCP will 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 describe 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 introduce a more systematic way of monitoring and evaluating overall effectiveness of the regulatory system.

Section 11 provides a general overview of how transparency will 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.

1.0 Introduction

1.1 CFIA's legislative authorities

The CFIA is dedicated to safeguarding human, 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:

  • Prevent, prepare for and manage:
    • human health risks;
    • animal and zoonotic diseases; and
    • plant pests, diseases and invasive species;
  • protect the Canadian environment from harmful contaminants;
  • contribute to consumer protection; and
  • facilitate market access for Canada's food, plants, animals and agricultural products.

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 model represents the CFIA's vision and its approach to regulatory inspection.

  • Agriculture and Agri-Food Administrative Monetary Penalties Act
  • Canadian Food Inspection Agency Act
  • Canada Agricultural Products Act
  • Consumer Packaging and Labelling Act (as it relates to food)
  • Feeds Act
  • Fertilizers Act
  • Fish Inspection Act
  • Food and Drugs Act (as it relates to food)
  • Health of Animals Act
  • Meat Inspection Act
  • Plant Breeders' Rights Act
  • Plant Protection Act
  • Safe Food for Canadians Act
  • Seeds Act

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 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 Agricultural Growth Bill was tabled in Parliament on 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 (CPLA). Regulations are currently being developed in accordance with the authorities of SFCA. Stakeholder consultations are underway. When the SFCA is fully in force, the majority of these Acts and their regulations will be repealed The CPLA and its regulations will be amended to remove the provisions related to food. 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 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 exemption provision will be undertaken during regulatory modernization.

1.2 Roles and responsibilities

1.2.1 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 information that is used in regulatory decision making.

1.2.2 Roles and responsibilities of the CFIA

The CFIA verifies industry compliance with the legislation through activities that include inspection and surveillance. 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 permission 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 from the Acts it administers. The CFIA may make use of alternative service providers through formal arrangements to complete inspection activities.

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. 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.

1.2.3 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:

  • Agriculture and Agri-Food Canada
  • Canada Border Services Agency
  • Canadian Grain Commission
  • Environment Canada, including Canadian Wildlife Service
  • Fisheries and Oceans Canada
  • Foreign Affairs, Trade and Development Canada
  • Health Canada
  • Natural Resources Canada, including Canadian Forest Service
  • Pest Management Regulatory Agency
  • Public Health Agency of Canada
  • Public Safety Canada

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 permission and inspections as required. The CFIA's electronic certification processes will be integrated as they are developed. Import related information, including permission numbers, will be captured in electronic transactions 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 in accordance with the Memorandum of Understanding entered into by the two Agencies.

Figure 2 - Roles and Responsibilities of Partners. Description follows.
Description for Figure 2 - Roles and Responsibilities of Partners

The image illustrates the various regulatory roles and responsibilities of partners. The image is composed of table with six columns. Each column represents a partner.

Headings

The six column headings read from left to right as follows:

  • International entities
  • CFIA
  • Federal Partners
  • Provincial/Municipal Agencies
  • Industry
  • General Public

Column Content

The International entities content reads as follows:

  • Global food, animal and plant supply
  • Market access and trade
  • Comparability and acceptance of relevant systems
  • Compliance with international standards

The CFIA content reads as follows:

  • Develops legislation, policies and standards as they relate to animal and plant health, seed, feed, fertilizer and food
  • Responsible for the delivery of federal food, animal and plant inspection programs
  • Investigates complaints, outbreaks and illnesses

The Federal Partners content reads as follows:

  • Develop policies and standards within their mandate as they relate to public health, food safety, animal and plant health and the environment

The Provincial/Municipal Agencies content reads as follows:

  • Inspection, public health and food safety, animal and plant health surveillance
  • Enforce laws within their jurisdiction

The Industry content reads as follows:

  • Responsible for meeting regulatory requirements

The General Public content reads as follows:

  • Responsible for proper handling of food, animals and plants

2.0 Permissions

Introduction

CFIA grants permission authorizing regulated parties to conduct specific activities.

There are two types of permissionFootnote 1:

  • With a Preventive Control Plan (PCP)
  • Without a Preventive Control Plan

Permissions are used to describe the relevant activities the applicant is approved to conduct and include licences, permits, registrations, authorizations, 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).Footnote 2

Regulated parties with frequentFootnote 3 transactions will be required to have effective PCPs in place in order to be granted permission. Parties participating infrequently in regulated activities (e.g., one-time imports or exports of a regulated article) subject to plant or animal health requirements may be eligible for permissions without PCPs. In most cases, an applicant requesting permission must be located in Canada or have a resident agent during the permission period, to enable the CFIA to carry out inspection activities and take compliance and enforcement actions as necessaryFootnote 4. However, for a food permission, non-resident importers will be permitted, if specific conditions are met.

Primary producers, such as growers, fishers and livestock producers, are not expected to be covered by the proposed permission regime. In circumstances where primary producers choose to import or export or are subject to domestic food, animal and plant requirements (e.g., those premises considered to be greater risk), a permission will generally be required. Primary producers are expected to comply with the applicable Acts and Regulations.

Permissions may be amended or suspended to address unforeseen events that are not addressed by the conditions of an existing permission (e.g., animal disease outbreak, plant pest detection, or contaminant event (e.g., a nuclear event)).

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 permission with a PCP

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

  • import;
  • export (e.g., facility prepares food for export); and
  • operate domestically, such as:
    • interprovincial businesses (e.g., food preparation);
    • regulated areas (e.g., to control animal disease and plant pests); and
    • high risk facilities (e.g., plant auctions and animal assembly centres, research and quarantine facilities, medicated feed manufacturers).

Not all operations involved in the preparation of commodities will require a permission - some may not be subject to permission. For example, regulated parties who only sell food within the province (intra-provincialFootnote 5) will not be subject to permission requirements. As well, regulated parties not required to obtain a permission could include the following:

  • transporters of food, unless there is a plant or animal health requirement (e.g., fresh apples that move from Ontario to BC are subject to plant health requirements);
  • facilities that store or retail commodities but are not involved in importing, exporting or preparing the commodity, provided it remains packaged and sealed from receipt to transportation, and meets the requirements of the relevant legislation;
  • those that export to countries that do not require Canadian export certification and for which there is no Canadian export regulatory requirement;
  • those that import pets (e.g., cats and dogs) from low risk countries; and
  • importers of the following plants and plant products from the US: cut flowers, house plants for personal use and most lumber without bark.

2.1.1 Permission requirements with a PCP

In order to obtain a permission, an applicant must:

  1. develop, implement, and maintain an effective written PCP to meet regulatory requirements;
  2. complete an application; and
  3. pay the permission fee.

An applicant for a permission will be required to attest to having an effective PCP that is commensurate with the nature of the operation and meets the criteria set out in Section 3 and Annex B, as applicable.

2.1.2 Period of validity of a permission with a PCP

A permission will be valid for a specified period.Footnote 6

2.1.3 Issuing, renewing and amending a permission with a PCP

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

2.1.3.1 Issuing a permission with a PCP

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

A pre-permission 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-permission inspection is required.

2.1.3.2 Renewing a permission with a PCP

A permission holder will be required to apply for renewal before the end of the permission's period of validity (e.g., a permission will not be renewed if there are any outstanding fees).

2.1.3.3 Amending a permission with a PCP

A permission holder will be required to request an amendment to the permission when there is a change in the business profile or operations. The permission holder's PCP 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 permission holder (e.g., import requirement due to a pest/disease country status change or a contaminant finding linked to the exporting country).

2.1.4 Suspension of a permission with a PCP

Reasons to suspend a permission include the following:

  • the permission holder failed to comply with the conditions of the permission or with provisions of an Act or its regulations;
  • there are unpaid fees; or
  • there is reason to believe that human, animal or plant health or the environment, may be compromised or endangered if the operations continue.

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

If a permission 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 permission with a PCP

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

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

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

2.2 Parties subject to permissions without a PCP

Applications for permissions without PCPs will be considered on a case-by-case basis. Such permissions will authorize regulated parties to conduct a specific activity with conditions to mitigate risk, as needed.

Examples include:

  • importation of live animals or plants for personal use (e.g., pet birds, horses for competition, or house plants;
  • domestic movement of personal property (e.g., machinery or animals) to or from areas for domestic control of a pest or disease; or,
  • exportation of live animals or plants to meet foreign country requirements.

This provides for flexibility and control over the movement/disposition of products or things. Permissions without PCPs may include conditions for movement of regulated articles into, within or out of Canada.

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; and,
  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:

  • zoosanitary certificate by an official veterinary inspector from the country of origin of an animal or animal products/by-products proposed to be imported;
  • phytosanitary certificate by a recognized plant protection authority from the country of origin of the plant or plant products proposed to be imported; or,
  • provisions for segregating a commodity imported for research.

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.

2.2.3.1 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.

2.2.3.2 Amending a permission without a PCP

A permission 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 has been rendered.

2.2.5 Cancellation of a permission without a PCP

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

  • at the request of the permission holder;
  • the permission was issued based on false or misleading information, or false or falsified documents submitted in or with the application;
  • the reason for suspension cannot be resolved;
  • the permission holder conducted the activity while the permission was under suspension; or,
  • there was a change in a hazard, foreign country requirements, or pest or disease status.

3.0 Preventive control plans

Introduction

A preventive control plan (PCP) describes a systems-based approach developed by regulated parties that focusses on prevention as a way to achieve compliance.

An effective PCP suitable to the operations, must be developed, documented, implemented, and maintained, as a condition of a permission. Permission holders and other regulated parties are responsible for monitoring and controlling their operations, correcting any non- compliance as it occurs, and maintaining ongoing compliance. Depending on the nature of the operation, PCPs will include some or all of the elements outlined in Annex B. The requirement for an effective PCP may be set out and/or referenced in regulation. PCPs must be made available to the CFIA upon request.

The process of managing a PCP will continually generate new information that could be used to actively improve operations in ways that foster regulatory compliance. The commitment of management is essential to the implementation and ongoing maintenance of an effective PCP. Management must ensure that employees and service providers are:

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

The PCP approach provides the regulated party with the flexibility to consider utilizing private certification schemes (e.g., Global Food Safety Initiative (GFSI), the International Organization for Standardization (ISO), Voluntary Scrapie Flock Certification Program) in the design of their plan. Alternative service delivery systems also identify elements that can be used to create a PCP (e.g., Greenhouse Certification Program, Canadian Heat Treated Wood Products Certification Program, Veterinary Biologics Guidelines, Hazard Analysis and Critical Control Points).

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

The PCP approach will accommodate most systems currently in use by industry. The proposed PCP requirements are similar to the above mentioned systems, but may differ in that the proposed PCPs must also address regulatory requirements (e.g., animal health, plant health, labelling, product quality, composition). Primary producers requiring a permission will benefit from existing On-Farm Food Safety Systems and Biosecurity Systems to meet legislative requirements. Regulated parties, including those currently operating under a systems approach, should be able to transition more easily to the new model.

The CFIA is developing model systems and tools to assist small businesses in meeting this requirement. The CFIA's Compliance Promotion Strategy will outline how regulated parties can seek guidance on achieving compliance. The main objective of the strategy is to increase awareness, improve understanding and foster continuous improvement.

Regulated parties who strive to adopt best practices and innovative, commercial or technological strategies could 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, PCPs will include all of the following elements, as applicable:

  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; and,
  7. traceability, control and complaints.

Each element listed above must address the following criteria:

a. Hazards and controls

The PCP will have to:

  • identify potential hazardsFootnote 7 at any stage in an operation or in the commodity, and specify control measures for these hazards (e.g., drug residues, pests and/or diseases, allergens);
  • identify regulatory requirements and specify control measures to achieve compliance (e.g., product composition, net quantity, quality [grade], label declarations, pest/pathogen exclusion);
  • identify the control measures that are to be validated, including any critical limits or tolerances;
  • describe how the regulated party will validate that the control measures will achieve the critical limits and the outcomes before implementation; and,
  • describe how the control measures will be re-validated whenever there is a change that may impact the process parameters.

b. Monitoring procedures

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

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

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 will include:

  • identifying an appropriately-trained responsible person to conduct the verification, other than the person who conducts the monitoring;
  • establishing the verification frequency;
  • recording the results of verification;
  • establishing procedures to follow when deviations occur;
  • where sampling and testing are used (of the environment or a commodity), the procedures will be described; and,
  • using accepted sampling and test methodologies that provide accurate and meaningful results (e.g., accredited laboratories and licensed seed samplers).

d. Corrective actions

The PCP will outline steps to be taken following a deviation, and will include:

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

e. Management review (review by the regulated party)

The regulated party will review the PCP and its associated records to assess its ongoing effectiveness. The review will include:

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

f. RecordsFootnote 8

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

The PCP will need to identify all records associated with each element, where and for how long they will be retained, including, but not limited to:

  • validation of control measures (e.g., critical limits or tolerances);
  • monitoring (demonstrating control of a hazard or regulatory requirement; e.g.,: shipping; purchase orders; training; equipment calibration; and maintenance, pest/disease management);
  • verification procedures;
  • complaints and how they were resolved;
  • deviations and corrective actions taken; and,
  • management review by regulated party.

4.0 CFIA Oversight

Introduction

CFIA oversight consists of the 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.

The type, frequency, and intensity of the CFIA's oversight activities will be more proportional to the risks that need to be managed.

As part of its modernization efforts, the CFIA will enhance its risk-based approach to its oversight activities. While the CFIA has always incorporated risk into its approach to oversight, the modernized approach will provide regulated parties with increased transparency and consistency. The CFIA will continue to verify compliance of regulated parties. However, the type, frequency, and intensity of the CFIA's oversight activities will be more proportional to the risks that need to be managed.

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. Scientific knowledge and tools available for analysing the risks associated with a variety of regulated commodities are constantly evolving. Canada is committed to using the modern tools and systems available for risk management and delivery of its oversight activities.

Risks, including health, environmental, economic, social, consumer protection and other types of risks, must be managed or eliminated during production, processing, importing and distribution. It is the responsibility of regulated parties to:

  • produce or import commodities that meet Canadian regulatory requirements;
  • mitigate identified risks associated with those commodities;
  • demonstrate a commitment to reducing risks associated with regulated commodities to an acceptable level through responsible practices such as:
    • surveillance and control measures;
    • processing controls (e.g., heat treatment, seed cleaning, bark removal, composting);
    • cross-contamination controls (e.g., sanitation and hygiene, establishment of buffer zones or controlled access areas); or by,
    • limiting exposure (e.g., containment prior to processing); and,
  • export commodities that meet the foreign importing country requirements.

Risk analysis at the CFIA is conducted according to international standards, as established by the relevant international organizations. It consists of three separate but integrated components: risk assessment, risk management and risk communication.

4.1 Risk Assessment

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 (including economic and social impacts) are considered in assessing risk. The CFIA also evaluates the risk of commodity misrepresentation and consumer deception (e.g., misleading information on labels) in order to support marketplace fairness. The likelihood of a hazardous event (e.g., the presence of a food-borne organism, invasive plant pest, or animal disease) and the magnitude/severity of its impacts following exposure are key components of risk assessment.

The CFIA will take a consistent and structured approach to analysing risks related to different regulated commodities by:

  • 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;
  • making the risk information accessible and transparent;
  • applying a risk-based approach to all commodities (food, animal, plant, seed, feed and fertilizer); and,
  • requiring the submission and evaluation of scientific data for certain CFIA regulated commodities to support authorization prior to import, manufacture, sale and release. These commodities (e.g., veterinary biologics, fertilizer, feed and seed) will remain subject to pre-market assessment and authorization as part of the comprehensive Agency approach to providing risk-based oversight. This process may be supplemented with post-market regulatory oversight including facility inspections.

The risk assessment model will include both the initial risk associated with the commodity/establishment, as well as the residual risk remaining after consideration of mitigating measures and compliance history.

Figure 3 illustrates the 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 initial risk (e.g., surveillance, research, industry data, country evaluations, international standards and knowledge of processes).

The analysis of surveillance data generated by the CFIA or recognized external partners provides useful information to support the 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 and domestic movement as well as pest or disease control and eradication programs.

The following example illustrates how the process for assessment of initial risk could be applied to food commodities. The CFIA will 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 normally support the growth of pathogens.

The CFIA will also determine residual risk by assessing and re-assessing PCPs (Annex B) or relevant equivalents, and the track record of parties (including premise inspections, 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.

4.2 Risk Management

Risk management refers to coordinated activities put in place to minimize or reduce an identified, unacceptable level of, risk. Risk-informed decisions take into account, where appropriate, other factors (beyond risk assessment results) for protection of human, animal or plant health or the environment, and for the promotion of fair trade practices. Examples of these factors include: market access requirements, Government of Canada priorities and risk intelligence (e.g., international trends and issues that may present new or divergent risks.

Allocation of CFIA resources for 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 initial risk, residual risk and other factors (e.g., market access requirements, Government of Canada priorities) into consideration to select the appropriate frequency, extent or types of oversight activities to achieve desired risk management objectives.

There are a number of other triggers that could impact CFIA oversight activities which can be included as elements of a risk management strategy. A process will be developed to evaluate the validity, jurisdiction and priority associated with these triggers. The potential triggers could include:

  • response to complaints, investigations, recalls or outbreaks/incursions in Canada;
  • results of concern arising from an oversight activity (e.g., inspection or surveillance);
  • information about a potential issue received from a third party (including, another government department, or an international trading partner);
  • a request for inspection by a regulated party (e.g., for export marketing purposes); or,
  • a request for an evaluation or inspection by a foreign trading partner or foreign delegation.

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

  • whether a PCP is an appropriate mechanism for addressing risks associated with a particular party or activity;
  • whether an inspection is required before granting permission;
  • the frequency, extent or type to which the CFIA will inspect, evaluate or monitor specific products, establishments, importers and exporters; and,
  • how the CFIA will conduct other oversight activities (e.g., marketplace monitoring and border blitzes).

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

  • enhance its oversight activities by adjusting the frequency, extent or type of oversight activities, such as enhanced directed sampling and testing; and/or
  • apply other compliance and enforcement tools to support compliance.

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

  • when a regulated party implements and maintains a PCP that exceeds minimum requirements;
  • in consideration of a regulated party's participation in a credible private certification scheme; and
  • when the effectiveness of a regulated party's PCP, in preventing and mitigating risks and achieving regulatory compliance, is consistently demonstrated through the regulated party's compliance history.

It should be noted that risk management is a continuing process that takes into account new information as it becomes available. Risk management decisions and their implementation will be regularly monitored and adjusted as necessary to ensure the continual achievement of CFIA's mandate to protect human, plant and animal health, and the environment.

4.3 Risk Communication

Risk communication refers to the mutually beneficial exchange of information between risk assessors, risk managers and stakeholders. The federal government is undertaking efforts on several fronts to foster greater openness and accountability, to provide Canadians with more opportunities to learn about and participate in government, to drive innovation and economic opportunities for all Canadians and, at the same time, create a more cost effective, efficient and responsive government.

The CFIA is committed to being as transparent as possible by making information available to Canadians on a proactive and ongoing basis in an effort to share knowledge and ensure accountability. The approach to transparency is based on guiding principles such as: usefulness, clarity, timeliness, accessibility and accountability.

The process for increasing the CFIA's capacity for risk communications will take a phased approach, starting with increasing the information available as well as expanding the technologies used to disseminate that information. The CFIA will continue to explore how to increase transparency in the risk assessment and risk management realm.

Click on image for larger view
Figure 3 – CFIA Oversight Process. Description follows.

Description for Figure 3 – CFIA Oversight Process

Figure 3 illustrates the risk-based approach to the 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 regulatory oversight appropriate in a given circumstance.

A series of six connected horizontal rectangular boxes flow from top to bottom starting with

  • Information for determining risk (examples), with an arrow pointing to
  • Determination of initial risk, with an arrow pointing to
  • Information for determining residual risk (examples), with an arrow pointing to
  • Determination of residual risk, with an arrow pointing to
  • Other information considered in risk management (exampes), with an arrow to circle back to Information for determining initial risk as well as an arrow pointing to
  • Selection of frequency, extent or type of oversight activities (e.g., inspection, monitoring, surveillance)

Rectangular box content

The first box, Information for determining initial risk, includes the following examples:

  • Commodity/type/origin
  • Volume of production/shipment, intended end-use, consumer target groups, destination
  • Environmental scanning, foresight 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

The second box, Determination of initial risk, reads as follows:

  • 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

The third box, Information for determining residual risk, includes the following examples:

  • Preventive Control Plan (PCP) or equivalent
  • Track records and performance history of regulated party and /or sector (data from oversight activities)

There is no additional text associated with the fourth box, Determination of residual risk

The fifth box, Other information considered in risk management, includes the following examples:

  • Government of Canada outcome areas and CFIA key priorities
  • Other risk intelligence (e.g., private certification schemes / audit, recognition by external standards associations)
  • Market access requirements

There is no additional text associated with the sixth box, Selection of frequency, extent or type of oversight activities

5.0 Overview of inspection

Introduction

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.

Inspectors will use a combination of traditional inspection (where the focus is on the end-product and processing environment) and evaluation techniques (e.g., record review, interviews, and observation) for assessing compliance and evaluating the impact of non-compliance. Import and export activities will involve a similar approach with the additional considerations detailed in Sections 6.0 and 7.0.

Inspectors will continue to have the required skills, understanding of the relevant science and technologies, information management tools and ongoing training for an effective and well-functioning regulatory system.

5.1 Inspection planning and priorities

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

  • inspection and surveillance data;
  • environmental scanning; and,
  • recalls and investigations.

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

  • complaints or pest/diseaseFootnote 9 or contamination events, or illness investigations;
  • results of an inspection process or sampling;
  • information about a potential issue received from:
    • another government department;
    • an international trading partner; and
    • another third party; and
  • a request for inspection by the regulated party for export or, where required by law, for interprovincial marketing purposes.

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:

four basic steps to inspection

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, pertinent observations will be recorded, including clarifying discussions. Additional objective information, such as physical samples, photographsFootnote 10, and copies of documents or records will also be collected. The process of conducting inspections could include the following activities:

  • Opening meeting: CFIA staff members will introduce themselves to the regulated party and outline the scope of the inspection. The regulated party will be provided the opportunity to confirm any changes to the company profile and the PCP (since last inspection).
  • 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.
  • Confirmation of scope: Based on recorded observations from the initial walk-through inspection, the scope will be confirmed or amended accordingly.
  • Conduct inspection: Inspection will include using traditional inspection and evaluation techniques (e.g., visual inspection, record review, interviews, sampling, etc.) to verify PCPs are implemented as written and whether controls are effective.
  • Determine compliance/non-compliance: The inspection findings will be analyzed to assess compliance with regulatory requirements. The risk (e.g., human, animal or plant health or the environment or economic or trade) associated with non-compliance will be considered to determine if regulatory response is needed.Footnote 11 All non-compliance must be corrected by the regulated party. All non-compliance can be enforced by the CFIA through graduated enforcement actions, up to and including recommendation for prosecution.
  • Completion of inspection report: The report will include the inspection findings, any non-compliance observed and the actions taken by the regulated party and/or the CFIA.

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 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 PCP 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 PCP, see Annex B.

6.0 Imports

The permission requirements proposed in the model apply to importers of regulated commodities. For importers with a permission and PCP, some example strategies can be found in Annex B, Element 1, sub-element 1.3. In some cases, such as a one-time permission, PCPs may not be required. However, import conditions will be specified as part of the permission 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. Prior to the entry of commodities into Canada, permissions with PCPs will enable risk mitigation of high risk imports at first point of entry (e.g., private quarantine facility).

The transition to a modernized inspection approach will be gradual and will enhance import controls by clearly defining the roles of all parties involved, particularly that of the importer.

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

  • on-site verification of the processing and production controls or foreign country evaluation cannot be conducted by the CFIA; or
  • the foreign country oversight system is not sufficient; or
  • they are recognized international standards for trade.

6.1 Preventive control plans

Importers do not have direct control over production in other countries and will therefore need to develop other strategies to address risks, including having records to demonstrate how these strategies are effective. This may include a supplier approval program (e.g., letter of guarantee, certificates of analysis).

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

  • Element 1: Process and product controls;
  • Element 6: Receiving, transportation and storage; and
  • Element 7: Traceability, recall and complaints.

Importers who are involved in further handling or repackaging of commodities will need to address all seven elements of the PCP.

6.2 Inspection

The inspection approach outlined in Section 5 will be used to verify the effectiveness of the importer's PCP.

When non-compliance is identified, the CFIA will take steps to prevent further product from entering the marketplace until corrective action has been taken, unless forfeited, destroyed, or removed from Canada.

The CFIA will also take steps to inform stakeholders and the competent authority in the exporting country when deemed appropriate. Depending on the nature and severity of non-compliance, the CFIA might review technical or other bilateral arrangements with implicated countries to determine whether amendments will be required.

6.3 Foreign country evaluation

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

Canada is a significant importing nation. Conducting a foreign country system evaluation 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.

Based on risk and available resources, the CFIA may choose to perform on-site foreign country system evaluation to review the requirements and oversight that a foreign country imposes on its domestic manufacturers. The results will feed into the CFIA oversight framework as part of the 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. For exporters with a permission and PCP, some example strategies can be found in Annex B, Element 1, sub-element 1.4.

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

7.1 Preventive control plans

An exporter's PCP will be required to address any foreign regulatory requirements (e.g., product identification requirements).

7.2 Inspection

The inspection approach in Section 5 will be used to verify the effectiveness of the exporter's PCP.

7.3 Issuance of export certificates

Under the model, export certificates will be issued based on the exporters' conformance with their PCP. Where the exporters' system has been recognized as meeting the importing country requirements, certificates could be issued without further lot-by-lot product inspection. If there is an inspection and/or foreign country requirement, the commodity certification of individual lots could be performed.

If notified by an exporter or importing country that a non-compliant commodity had been exported, the CFIA will take appropriate steps to ensure corrective actions are carried out. If not already aware, trading partners will be alerted to this non-compliance using established protocols.

8.0 Regulatory Response

Introduction

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 the Agency aims to control, such as pest and disease incursions and contaminant events.

This response includes various activities as described in the CFIA's Compliance and Enforcement Policy. Under the model, a single, consistent policy will be applied that is transparent and appropriate across all commodities.

The CFIA responds to lack of compliance by regulated parties and aims to control pest and disease incursions and contaminant events.

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

As the regulatory frameworks are modernized, this policy will be reviewed and updated as required. The CFIA understands that many regulated parties' business models will 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 will 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 will also be used in the initial stages of implementing the model.

The processes that lead to inspection decisions–or compliance and enforcement actions–must be objective, impartial, risk-based 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 risk factors, including:

  • the potential for harm, such as:
    • the degree to which non-compliance has impacted or has the potential to impact human, animal or plant health, or the environment, or economic or trade impacts;
    • the magnitude of the non-compliance; and
    • whether the commodity is within the regulated party's control;
  • the intent of the regulated party, including:
    • whether non-compliance was intentional, accidental or negligent; and
    • the extent to which the regulated party had exercised due diligence;
  • the regulated party's demonstrated performance, including:
    • its compliance history;
    • the history of complaints; and
    • the level of commitment by management.

Specific responses could be directed at the commodity (e.g., quarantine or detention) and/or the regulated party (e.g., suspension of a permission). 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 and healthy food, 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.

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

CFIA Response:

A written report of the non-compliance is issued to the regulated party. The non-compliance must be addressed to prevent recurrence.

Appropriate regulatory control and enforcement actions will be taken by the CFIA based on the non-compliance. Control actions may include quarantine, seizure and detention, recall, disposal, etc.

For example, an importer who has a history of importing non-compliant commodities may be required to submit evidence of compliance before the CFIA will 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 PCP have been documented.

Failure to satisfactorily resolve the non-compliance will result 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 suspected regulated animal disease, plant pest incursion or contaminant event in Canada, premises with or without permissions may be subject to regulatory control actions to limit the spread.

Trigger: When the CFIA becomes aware of the potential presence of a pest, disease or contaminant, regulatory control actions may be applied depending on the level of risk. An inspection to determine its presence is performed and confirmed according to established procedures.

CFIA Response Phase 1: Initial Management

Based on risk, the CFIA determines the scope of regulatory control actions and appropriate response required to contain or remove the contaminant, pest or disease.

These regulatory response activities continue until:

  • the threat is removed from the premisesFootnote 12; or
  • a policy decision is taken that it is more appropriate to de-regulate the contaminant, pest or disease rather than continue to attempt control or eradication; or
  • a long-term management option is chosen.

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. Permissions with PCPs 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 permission of this type may also be used for international trade out of a regulated area or recognized special status premises.

Regulatory Response

Click on image for larger view
Figure 4 – Regulatory Response. Description follows.

Description of Figure 4 – Regulatory Response

Across the top of the diagram, outside the shaded areas, there are 4 boxes with thick arrows pointing down. These align as four columns with shaded areas below each

The first vertical column called, Regulated Parties, points down to four boxes of regulated parties that read as follows:

  1. Permission (PCP)
  2. No permission (PCP)
  3. Permission (no PCP)
  4. No permission (no PCP)

The next three vertical columns contain two horizontal areas with shaded 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. These two events may use similar tools to be brought into compliance and both may be occurring at the same time.

The second vertical column called, Possible Triggers, points down to 2 boxes that read as follows:

  1. Non-compliance
  2. Contaminant/Plant Pest/Animal Disease – Suspected or Detected

Between the four 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 vertical column called, CFIA Action, points down to 2 boxes that read as follows:

  1. Notification to Comply – this box has a red CFIA regulatory tool kit symbol indicating that regulatory control or enforcement action could be considered.
  2. CFIA orders/ requires regulatory control action is contained in a gold box that denotes – Phase one (short term goal of control or eradication) – this box also has a red CFIA regulatory tool kit symbol indicating that regulatory control or enforcement action could be considered.

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

Each CFIA action box has a horizontal arrow pointing to a diamond shaped box, which indicates the result of the action from the previous box.

  1. The top diamond says, Regulated party implements corrective actions
  2. The bottom diamond says, Contaminant eliminated, Pest/Disease eradiciated

From each of the diamonds are two arrows leading to containing either Yes or No.

The fourth vertical column called, Outcomes, points down to five boxes that read as follows:

  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 CFIA regulatory tool kit symbol indicating that regulatory control or enforcement action could be considered
  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 breaks into two boxes and possible outcomes:
    1. Deregulated
    2. Contained in a gold box that denotes – Phase two - pest/disease requires ongoing management/movement controls. This box has an arrow leading to the regulated party column and to the Permission (PCP) box. Regulated parties in phase 2 would then require PCPs and permission.

Outside and under the shaded diagram is a small box. It is a dotted box called the CFIA Regulatory Tool Kit. This box has a red symbol that is in various boxes in the shaded diagram. The CFIA regulatory tool kit box reads as follows:

  1. CFIA control actions, e.g., Seizure and Detention, Quarantine Notices, Movement Controls, Treatment Order, Recall
  2. Enforcement Actions, e.g., Suspend/Cancel Licence/Permit, AMPS, Recommendation for 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 (CFIAA) 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. The ability of a review officer to vary, cancel or confirm prescribed decisions will require regulations to be made setting out the parameters of the process before the authority may be exercised. CFIA decisions other than those prescribed in regulation will continue to be reviewed by the CAO under the administrative complaint process.

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

10.0 System performance and continuous improvement

Introduction

As part of inspection modernization, the CFIA is also modernizing its approach to performance measurement. This new approach recognizes 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 through program management 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. This will require stakeholder engagement and a continued commitment to work collaboratively to maintain system effectiveness.

Establishing key desired program management 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:

  • the effectiveness of the inspection system as part of the broader system;
  • whether the regulatory program is risk-oriented and proactive;
  • whether the program is delivered as designed, and in a risk-based, consistent, efficient, relevant, and professionally conducted manner; and
  • whether all participants in the system, including other governing and regulatory bodies, regulated parties, industry representatives and associations, and Canadians are engaging, sharing information, acting responsibly, constructively supporting and remaining confident in the system; and

to identify:

  • emerging risks; and
  • areas for system performance improvement.

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

  • corporate reporting;
  • benchmarking over time;
  • international comparative analysis;
  • continuous improvement of program design, training, and inspection delivery; and
  • adjusting work plans.

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 will be conducted and system improvements will 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 will be iterative and mature over time. Performance information will be communicated to Canadians through various vehicles including the Departmental Performance Report.

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:

    • Is there a risk-based and proactive regulatory framework for the program?
    • Are policies clear, complete and current?
    • Does the program support innovation?
    • Does the program include appropriate tools and supporting processes, including effective work planning and training?
    • Are the outcomes clear and achievable for inspectors?
    • Does the program define the external stakeholders and their roles, responsibilities and expected influence on the system?
    • Have the outcomes of the program been achieved?
  • b) Consistency and quality of service delivery

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

    • Are work plans delivered?
    • Are investment, efficiency and service standards met?
    • Are inspection, sampling and testing steps followed?
    • Are inspection forms complete and accurate?
    • Are decisions consistent?
    • Were change-initiative plans delivered and expectations met?

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:

  • Do CFIA processes appropriately engage all key stakeholders?
  • Do key stakeholders understand key CFIA messages and requisite duties, obligations and needed actions?
  • Are the outcomes clear and achievable for all key stakeholders and do stakeholders understand their role in achieving outcomes?
  • What is the compliance profile of regulated parties and their status relative to trends in the industry?
  • Has the CFIA been successful in facilitating access of Canadian regulated commodities to international markets?
  • Is the system accepted internationally?
  • Have key participants who play a role in the system and influence the ultimate outcome of protecting consumers, animals, plants and the environment from preventable health and safety risks achieved the outcomes expected of them?

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:

  • How effective was the regulatory system in meeting the CFIA's strategic outcomes?
  • Were risks to the system managed? Were emerging risks identified?
  • What is the risk versus compliance profile and what are the trends by program, industry and overall?
  • Is the system accepted internationally and are risks of trade barriers managed?
The Regulatory Systems Results Model

Click on image for larger view
Figure 5 - The Regulatory Systems Results Model. Description follows.

Description for 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 Data Collection Strategy will be developed, ensuring that there is capacity to collect analyse and ensure consistency of data as well as maintenance of data integrity. 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 will be focussed both internallyFootnote 13 and externallyFootnote 14 and be either continuous or periodic. Assessment results will be used for;

  • learning what works, in what conditions and for whom;
  • changing activities to solve or avoid mistakes or problems;
  • correcting the underlying causes behind problematic action;
  • reporting on the CFIA's accountabilities; and
  • demonstrating transparency regarding our commitment to system performance.

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:

  • confirm if standards are consistently and thoroughly followed and enforced;
  • confirm if the activities are consistently achieving expected results;
  • identify any universal challenges and/or concerns; and
  • identify opportunities to increase transparency.

Performance measurement is not an isolated activity, but part of a continuum of monitoring and reporting activities that take place through the entire life-cycle of a project, program or initiative. As such, a balanced and integrated approach will be used to get the full picture of the performance within the Agency. This is why it will be important to closely link performance measurement, audit and evaluation in the same continuum.

Examples of current performance assessment tools available:

  • Field Observation – assesses 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.
  • Quality Management – assesses internal performance by tracking compliance with internal protocols, service standards and expectations.
  • 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.
  • Evaluation – as per the Treasury Board Policy on Evaluation, conduct internal evaluations regarding the relevance and performance of programs, initiatives and policies.
  • Surveys – assess internal and external performance by seeking feedback 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 consumers' 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:

  • behaviours of regulated parties are influenced and trends towards improvements in compliance levels are observed;
  • continuous improvement becomes an objective of all regulated parties; and
  • consumers are better informed and have confidence in the CFIA's regulatory inspection system.

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:

  • food imports that have been ordered removed from Canada by the CFIA;
  • regulated parties whose permissions have been suspended, cancelled or reinstated;
  • reports of non-compliant and disposed food products; and
  • Administrative Monetary Penalties.

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 appeals
    • The CFIA's Complaints and Appeals Office provides stakeholders with a more transparent and accessible way to register complaints and appeals related to quality of service, administrative errors and regulatory decisions. Data from this process can help to improve information distributed to regulated parties.
  3. Information sharing
    • The CFIA is moving to become even more transparent and is committed to working with, and soliciting feedback from stakeholders on the Agency's approach to its next phase of transparency.

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

  • posting online listings of businesses that are licensed, registered or otherwise subject to government oversight;
  • posting online summaries of the most common inspection observations of objectionable conditions or practices that are made during inspections;
  • posting results from targeted surveillance activities designed to establish baseline safety or compliance levels;
  • providing inspection result summaries online that include the name and address of the inspected establishment, the date(s) of inspection, the type of regulated commodities involved, and inspection findings; and
  • alerting the public in a consistent manner about enforcement actions by making information available through news releases and social media outlets.

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

  • the effectiveness of the inspection programs; and,
  • how well regulated parties are complying with regulations.

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 permission, an applicant must:

  • develop, implement, and maintain a written PCP to meet regulatory requirements (if required);
  • complete an application; and
  • pay the permission fee.

An applicant for a permission will be required to attest to having implemented an effective PCP (if required) that is commensurate with the nature of the operation(s) 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)
    1. business name and operating name
      • copies of the applicant's articles of incorporation or provincial registration, if any
    2. legal (civic) address (physical location) in Canada
      • all physical location(s) covered under the permission in Canada
      • GPS location, if needed, to ensure accurate site/field/animal identification
      • Provincial Premises ID
    3. mailing address (if different from legal address)
    4. address where records will be available (if different from legal address)
    5. fax/telephone number, email address, website (if available)
    6. name of operator (permission holder)
    7. name of primary contact person at each physical location
    8. 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 assembly centres, 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, package, 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:
    1. Business status (applicants must check all options that apply)
      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)
    2. Hours
      1. hours of operation
      2. days of operation
    3. Business size
      1. number of employees working in each establishment (ranges will be provided as options)
      2. estimates of annual volume of production / number of importations or exportations of commodities (ranges will be provided as options)
  7. Commodity information for each activity covered by the individual permission must be described:

    Food

    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 (e.g., additives, processing aids)
    9. Fruits and vegetables
    10. Grain-derived foods (e.g., breakfast cereal, bread and bakery, pasta, milled grain products)
    11. Honey
    12. Infant foods
    13. Maple products
    14. Meat and poultry
    15. Multiple/mixed foods (e.g., pizza, frozen meals, sandwiches)
    16. Nuts, grains, seeds
    17. Spices, herbs, flavours, condiments, dressings
    18. Other

    Animal

    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

    Plant

    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)

    Food

    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 will 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., animal assembly centres, pet food)
    13. disease control
    14. quarantine facility
    15. other (e.g., cervid movement, zoos, in transit)

    Feed

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

    Plant

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

    Seed

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

    Fertilizer

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

Amendments and renewals

For amendments and renewals, permission holders will access their unique account in the CFIA web portal; select the desired activity (e.g., renewal, amendment); modify the information in the application form, as applicable; pay the required fee, if any and submit.

Process for issuing a permission

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-permission 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 may be sought.
  4. The Minister (or delegate) may refuse to issue a permission if the applicant
    • does not meet permission conditions;
    • has submitted inaccurate information;
    • has provided false or misleading information, documents or records; and
    • engaged in deceptive practices in order to obtain a permission.

Step 2: Communication of decision

  1. Notification will be sent if a pre-permission inspection is required.
  2. If a permission is refused, a written notice of refusal will be sent, with the reasons for the refusal.
  3. The applicant will be able to present facts in support of a request for review by the CFIA.

Step 3: Decision review

The CFIA is considering options for a review mechanism that will be available to regulated parties following a decision to refuse to issue a permission.

Process for suspending a permission

Step 1: Initiation

  1. If a CFIA inspector identifies non-compliance as per Section 2 (Suspension of a permission), 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 permission holder will receive a report of the inspection and will be provided with an opportunity to remedy the non-compliance.Footnote 15

Step 2: Evaluation

  1. If the non-compliance is not addressed, the permission will be suspended. The Minister (or delegate) will review the findings and, if required, expert advice may be sought.Footnote 16
  2. The Minister (or delegate) will render a decision concerning suspension of the permission in question.

Step 3: Communication of decision

  1. If the permission is suspended, the permission 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 permission re-instated, the permission holder must submit a written plan to address the issues that resulted in suspension of the permission.
  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, lift the suspension and close the file. Additional conditions may be imposed on the permission by the Minister (or delegate).
  4. If the issues are not resolved, the CFIA will initiate cancellation of the permission (see below).

Process for cancelling a permission

Step 1: Initiation

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

Step 3: Communication of decision

If the permission is cancelled or suspended, the permission holder will receive a written notice of the decision and the reasons for it.

Annex B: Elements of a preventive control plan

Depending on the nature of the operation, preventive control plans will include some or all of the following elements. Each element of a preventive control plan has associated outcomes and performance criteria. A regulated party will address the criteria to support achieving the outcome.

Adjacent to the performance criteria listed below for each sub-element are the related inspection activities that inspectors could use to assess compliance.

The general inspection steps in Annex C will be utilized.

Element 1: Process and product control outcomes and performance criteria

1.1 Process control

Outcome
  • The process is controlled to achieve regulatory compliance.
Rationale
  • Inadequate input controls could result in non-compliance (e.g., product contamination, inadequate processing, misrepresentation of the product, infestation, unapproved propagation, residues, etc.).
  • Inaccurate product formulation and/or mixing could result in non-compliance (e.g., 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.
Process Control: Regulated Party Performance Criteria and Inspection Activities
Regulated Party Performance Criteria Inspection Activities

a. Incoming inputs (e.g., ingredients, raw materials, plants and animals):

  • are identified and their source (e.g., the immediate supplier);
  • are identified and verified, with written specifications, if:
    • there is a potential hazard;
    • an input is critical to biosecurity, product composition, health status and/or nutrition profile; and
  • have documented handling procedures to prevent hazard introduction, and contamination and maintain integrity and animal welfare (where applicable).

a. Incoming inputs (e.g., 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.
  • Check whether inputs are properly identified and segregated as required.
  • Observe how inputs are received to verify that there is no cross-contamination, and integrity and animal welfare (where applicable) are maintained.

b. Product formulation and specifications:

  • have written formulas for each product that is being prepared;
  • have written specifications for each final product; and
  • use additives and chemicals (including medicating ingredients, drugs and vaccines) that are permitted in and on the commodity.

b. Product formulation and specification

  • Review the types of products prepared.
  • Confirm that the current formula and/or specification is available and documented for each product.
  • Confirm that additives, drugs, chemicals and medicated ingredients are approved for use in and on the commodity.

c. Processing has:

  • A written description of
    • processing steps (e.g., mixing records, humane slaughter), associated control measures and critical limits;
    • commodity movement (e.g., process flow diagram); and
    • commodity changeover procedures;
  • critical limits validated using scientific data (e.g., heat treatment for lumber or milk).

c. 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 adjustments to processing or product identification;
    • inputs are accurately measured and blended;
    • processing controls are monitored and critical limits/tolerances are met; and
    • animal welfare principles are followed where applicable.
  • Review process validation records to confirm that processes, critical limits 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 cross-contamination is controlled.

1.2 Product control

Outcome
  • Finished products meet regulatory requirements including appropriate packaging and product identification.
Rationale
  • 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
Product Control: Regulated Party Performance Criteria and Inspection Activities
Regulated Party Performance Criteria Inspection Activities

a. Packaging

  • There are written specifications for packaging materials that come in contact with commodities.
  • All packaging materials are suitable for the intended use.

a. 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.

b. Product identification

  • Information is complete, truthful and not misleading. It also accurately represents the commodity and its content, and meets regulatory requirements.

b. Product identification

  • Select a commodity or commodities to verify that product identification accurately represents content and meets regulatory requirements. For example:
    • food commodities containing priority allergens are labelled;
    • nutrition labelling requirements are met (e.g., feeds);
    • all nutrition claims are factual, not false and not misleading; and
    • any other product identification requirements are met, including mandatory information (e.g., heat treatment of wood, type size, bilingual requirements, net quantity declarations, ingredient declarations, health or product claims).

c. Finished Product

  • Finished product is evaluated for compliance with regulatory requirements.
  • Outgoing commodities and their destination are identified, including those destined for export (e.g., the immediate purchaser is identified).

c. 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.

1.3 Import control

Outcome
  • Imported commodities meet regulatory requirements. e.g., phytosanitary certificates, zoosanitary certificates.
Rationale
  • 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.
Import Control: Regulated Party Performance Criteria and Inspection Activities
Regulated Party Performance Criteria Inspection Activities

a. Control measures and sourcing are done to ensure that commodities meet Canadian requirements. Possible strategies include:

  • selecting suppliers whose exports are certified by a foreign country competent authority;
  • selecting suppliers who are identified on a list of eligible exporters by a foreign country competent authority;
  • selecting suppliers who are subject to internationally recognized third-party evaluations;
  • evaluation to confirm suppliers can meet Canadian requirements;
  • selecting suppliers who conduct regular sampling and testing and provide certificates of analysis; or
  • using accredited or recognized sampling and testing laboratories to do testing at the time of importation.

a. Review imported product records to determine:

  • what commodities were imported and from where, including in-transit information for animal and plant health;
  • the results of control measures and country of origin to verify compliance with Canadian requirements (e.g., certificates of analysis, evaluation results, competent authority certification);
  • the results of quarantine facility observation and evaluation; and
  • if any commodities were rejected, what issue was identified and what corrective action was taken.

1.4 Export control

Outcome
  • Exported commodities meet foreign country import requirements and conditions and Canadian export requirements, where applicable.
Rationale
  • Commodities that do not meet foreign country import requirements jeopardize trade or meet international obligations.
  • Commodities for export may not be permitted in Canada and need segregation to prevent them from reaching the Canadian marketplace.
Export Control: Regulated Party Performance Criteria and Inspection Activities
Regulated Party Performance Criteria Inspection Activities

a. Written procedures and records to demonstrate that the commodity to be exported meets foreign country import requirements

a. Review exported commodity shipment records to determine:

  • what commodities were shipped;
  • to which countries shipments were conveyed;
  • the results of quarantine facility observation and evaluation; and
  • that the foreign country requirements were met.

b. Verification that the export requirements are being met, which includes records of rejected shipments to foreign countries including reasons for rejection.

  • When export certificates are issued by the CFIA, the regulated party will notify the CFIA when a shipment is rejected because of evidence of a human, animal or plant health concern in the importing country.

b. Review records to determine if any shipments were rejected and, if so, what was the issue and what corrective action was taken.

c. Control and segregation of commodities destined for export that do not meet Canadian requirements and are not permitted to enter the Canadian marketplace (e.g., poultry feet harvested prior to post mortem inspection for export to Jamaica).

c. Review shipment records to ensure that those commodities that do not meet Canadian requirements are segregated and not distributed in Canada.

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

2.1 Sanitation/ biosecurity/ biocontainment

Outcome
  • Effective sanitation of equipment and premises is in place to prevent contamination of the commodity
  • Effective biosecurity and biocontainment is in place to prevent the introduction, establishment or spread of pests and/or disease.
Rationale
  • Improper or inadequate sanitation/ biosecurity/ biocontainment, activities can lead to contamination of commodities, premises, packaging materials and contact surfaces or the spread of diseases and pests.
Sanitation/Biosecurity/Biocontainment Control: Regulated Party Performance Criteria and Inspection Activities
Regulated Party Performance Criteria Inspection Activities

a. Procedures are in place for all appropriate areas of the premise (e.g., receiving, production, storage and shipping) providing processes and the schedule for cleaning, sanitizing and/or biosecurity/biocontainment which includes:

  • processes, directions for use of chemical or biological products that ensure use is within label rates;
  • temperature and/or pressure as required;
  • other requirements as applicable;
  • equipment, including equipment used for cleaning and/or sanitizing and/or biosecurity/biocontainment; and
  • equipment and processes are capable of delivering the requirements of the sanitation program and/or biosecurity/biocontainment program.

a. Confirm cleaning and sanitizing and/or biosecurity/biocontainment is being done according to the documented procedures and schedule. Review records:

  • to verify that cleaning and sanitizing and/or biosecurity/biocontainment processes are effective;
  • to verify that cleaning or sanitizing and/or biosecurity/biocontainment equipment is functioning as intended;
  • to identify any issues or deviations and note what actions were taken; and
  • of sampling results, if applicable.

b. Cleaning and/or sanitizing and/or biosecurity/ biocontainment is carried out in a manner that does not contaminate commodities or spread diseases, pests or pathogens, during or after cleaning and/or sanitizing and/or biosecurity/ biocontainment.

b. Review records, observe and interview employees responsible performing the activity to verify that cleaning and sanitizing and/or biosecurity/biocontainment:

  • are taking place;
  • cross-contamination is controlled effectively (e.g., floor sprays are not contaminating food contact surfaces, foot baths are not contaminating barns), and that there are no other sources of cross-contamination; and
  • to verify temperature, chemical concentrations and pressures.

c. Effectiveness of cleaning, sanitizing and/or biosecurity/ biocontainment is assessed visually or through sampling (e.g., environmental, product, sentinel animals, plants) using accepted methods or procedures, as applicable.

  • Contact surfaces are free from contamination (e.g., the accumulation of dust, dirt, food residue and other debris).
  • Environmental sampling is conducted in accordance with approved procedures (e.g., Health Canada 2011 Policy on Listeria monocytogenes in Ready-to-Eat Foods; Plant Health directives and policies; Hatchery Program, potato cyst nematode biocontainment program).

c. Visually verify that cleaning and/or biosecurity/biocontainment procedures are effectively removing dirt, debris or any other contamination risk.

  • Look for evidence of pest or disease, dirt, debris and residual material on direct commodity contact surfaces, including containers and utensils.
  • Take samples to determine effectiveness and compliance if necessary to confirm observations.

2.2 Pest Control

Outcome
  • 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.
Rationale
  • Pests, including vectors, (e.g., 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 (e.g., from manure, insects or contaminated soil, animals or plants).
Pest Control: Regulated Party Performance Criteria and Inspection Activities
Regulated Party Performance Criteria Inspection Activities

a. There is a documented program for prevention, control and removal of pests, including vectors.

a. Review records and program for prevention, control and removal of pests, including vectors.

b. There is a schedule for monitoring for evidence of pest activity, including vectors.

b. Review records and visually verify that there is no evidence of pests, particularly in processing, propagation/growing, storage and handling areas. If there is evidence of pests, review records to:

  • Identify if there are any trends; and
  • Confirm what actions have been taken to address the issue, including identification of the pest; source of infestation; and preventive measures to prevent reoccurrence.

2.3 Chemicals

Outcome
  • 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.
Rationale
  • The use of improper chemical concentrations and/or improper chemical application or rinsing procedures can lead to both chemical contamination (e.g., chemical residue due to poor rinsing, rinse chemicals in excess of approved concentration) and biological contamination (e.g., pest or pathogens not effectively removed).
  • Improperly stored chemicals can lead to contamination or harm to humans, animals, plants, or the environment.
Chemicals: Regulated Party Performance Criteria and Inspection Activities
Regulated Party Performance Criteria Inspection Activities

a. A listing of chemicals or specification sheets for chemicals used in biosecurity/ biocontainment, sanitation, treatment, and pest control is maintained.

a. Confirm via records that there is a listing of chemicals used including pesticides (e.g., rodenticides, nematicides) and specification sheets available.

  • Chemicals used on commodities or contact surfaces meet the requirements of the applicable legislation (e.g., FDA, PCPA).

b. Chemicals are handled, used and applied by trained personnel.

b. Confirm, via records and interviews, employee or applier is trained to apply the treatment or chemical.

c. Chemicals are used according to their label intended use.

c. Confirm, via records and interviews, label instructions for any chemicals used are being followed.

d. Documentation is maintained that supports appropriate use of chemicals and prevents contamination of commodities, equipment, tools or contact surfaces.

d. Confirm, via records and interviews, the chemicals were applied in a manner that prevents cross-contamination.

e. Chemicals are properly stored, controlled, and labelled.

e. Confirm via records and interviews that chemicals are stored separately, clearly identified and dispensed with tools or equipment used only for chemicals.

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

3.1 Hygiene and biosecurity

Outcome
  • Employees and visitors are not a source of contamination.
Rationale
  • Employees and visitors who do not follow hygienic and biosecurity practices can cause contamination or spread pests/diseases.
Hygiene and Biosecurity: Regulated Party Performance Criteria and Inspection Activities
Regulated Party Performance Criteria Inspection Activities

a. Effective, documented biosecurity practices are in place, including;

  • controlled access;
  • working from low to high risk areas (e.g., propagation house to outside beds);
  • employee facilities, hand-washing and sanitizing stations; and
  • use of sanitary clothing and footwear.

a. Review records and observe biosecurity practices to verify they are being followed.

  • Movement of employees and access of visitors is controlled.
  • Sanitizing stations (e.g., footbaths and hand dips) are properly maintained.
  • Any required clothing–including gloves, hair coverings, and footwear–is maintained and stored in a sanitary manner.
  • Employee hand-washing facilities are available and clean.

b. Hygienic practices are in place, including:

  • proper hand-washing or use of sanitizers/gloves or boot wash;
  • rules for employee conduct; and
  • precautions for personnel with open wounds or a communicable disease.

b. Observe employees and interview to confirm:

  • employees are washing hands when required (e.g., when returning to the processing area);
  • personal objects are prevented from contaminating the commodity (e.g., falling into the commodity);
  • unhygienic practices are not occurring or contributing to contamination of the commodity (e.g., moving from high risk to low risk areas, spitting, use of tobacco, chewing gum, consuming food); and
  • that employees handling commodities do not have open wounds or exhibit signs of a communicable disease.

3.2 Employee training

Outcome
  • 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.
Rationale
  • Employee training and hygiene contribute to the production of safe food, healthy animals and plants and effective biosecurity practices.
  • Proper training promotes an understanding of the risk of biological, chemical and physical contamination and the employee's role in maintaining hygiene and biosecurity.
Employee Training: Regulated Party Performance Criteria and Inspection Activities
Regulated Party Performance Criteria Inspection Activities

a. A written description of training requirements and training records for employees responsible for activities under the PCP are in place and maintained.

a. Review training requirements, observe and interview employees to confirm they have the appropriate technical knowledge to carry out their respective duties. For example, they may need an understanding of:

  • potential sources of contamination, infestation or infection;
  • proper handling of food, plant, and animal commodities and inputs (e.g., temperature control, segregation of animal, plant or food commodities);
  • personal hygiene;
  • equipment maintenance and calibration; and
  • general sanitation and cleanliness.

b. Employees are trained to carry out the range of tasks and duties they are required to perform.

b. Review training records to confirm that employees have received training, including ongoing training, to maintain current specialized knowledge; such as, knowledge of control measures and critical limits/tolerances or regulatory requirements.

c. Effectiveness of training is monitored and verified.

c. Review records and observe employees to confirm they are following procedures when carrying out duties.

Element 4: Equipment design and maintenance outcomes and performance criteria

4.1 Equipment Design and Maintenance

Outcome
  • 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 used to meet regulatory requirements are calibrated for accuracy.
Rationale
  • 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.
Equipment Design and Maintenance: Regulated Party Performance Criteria and Inspection Activities
Regulated Party Performance Criteria Inspection Activities

a. All equipment, utensils, containers, and controlling and measuring devices used in commodity preparation and storage are:

  • used only for the premises' intended purpose;
  • functioning as intended;
  • maintained in a good state of repair;
  • cleanable; and
  • properly stored.

a. Confirm that equipment is being used as per procedures and review maintenance records, if necessary.

  • Check that equipment, containers and utensils are in good repair (e.g., check for rust, peeling paint, leaking lubricants).

b. Controlling or measuring devices used in the preparation of commodities are calibrated and maintained to ensure measurement accuracy and effectiveness.

b. Confirm that equipment is being calibrated according to schedule.

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

5.1 Premises and surroundings

Outcome
  • Conditions of the premises and surroundings do not contribute to contamination, infection or infestation of regulated commodities.
Rationale
  • Outside sources of contamination can compromise the safety, health and/or quality of the commodity.
Premises and Surroundings: Regulated Party Performance Criteria and Inspection Activities
Regulated Party Performance Criteria Inspection Activities

a. The surroundings/roadways are maintained to minimize refuse, dirt, dust, fumes and other environmental contaminants and pest harbourage areas.

a. Review maintenance records and visually verify that sources of external contamination are controlled (e.g., build-up of garbage, alternative pest hosts (e.g., barberry is an alternative host for wheat stem rust)).

b. Isolation and buffer zone cleaning and sanitation practices are implemented to minimize the risk of contamination, infestation or infection, as applicable.

b. Review maintenance records and visually verify that the isolation and buffer zone cleaning and sanitation practices are implemented in accordance with procedures.

5.2 Buildings

Outcome
  • Buildings are constructed and maintained to support cleaning and sanitation and prevent the entry of pests and contaminants.

Rationale

Inadequate commodity controls could result in:

  • Proper facility design and construction, including maintenance, prevents or mitigates the entry of pests or contaminants.
  • 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 (e.g., presence of bacteria, mould).
  • Proper protection of glass will prevent foreign material contamination of commodities, ingredients, packaging materials and contact surfaces.
  • Separation or control between incompatible operations helps to prevent cross-contamination.
  • Control is inadequate if cross-contamination occurs.
  • 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.
  • 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.
  • 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.
Buildings: Regulated Party Performance Criteria and Inspection Activities
Regulated Party Performance Criteria Inspection Activities

a. Exterior and Interior building structures

  • The exterior of the building is maintained to prevent entry and/or escape of pests and contaminants.
  • Floors, walls and ceilings are:
    • cleanable;
    • made of materials that will not contaminate regulated commodities; and
    • in good repair.
  • In preparation areas:
    • floors are constructed and maintained to permit adequate drainage.

a. Exterior and interior building structures

  • Review maintenance records and visually inspect the building interior and exterior, including the air filter replacement records.
  • Check that floors, walls and ceilings are made of appropriate materials (e.g., non-porous materials in food preparation areas) that will withstand cleaning, and that floors are draining properly.
  • Check that glass is properly protected in places where breakage could contaminate commodities.
  • Confirm that:
    • openings to exterior areas are protected or effective control measures are in place;
    • air intakes and exhausts, as appropriate, are filtered or positioned to prevent the introduction of contaminants;
    • doors are tight-fitting and equipped with self-closing devices, if required; and
    • there are no signs of water or fluid leakage (e.g., hydraulic lines, waste water).

b. Hygienic flow and separation

  • Where there is potential for cross-contamination, incompatible operations are controlled by physical separation or other effective means.

b. Hygienic flow and separation

  • Review production records and visually confirm that incompatible operations are controlled by physical separation or other means (e.g., sequencing of commodities to prevent introduction of allergens or cross-contamination).

c. Lighting

  • There is sufficient light to allow the intended activity to be conducted effectively.
  • Lighting equipment (bulbs and fixtures) that is located where breakage could contaminate commodities is protected, as needed.

c. Lighting

  • Review maintenance records and visually verify that lighting is adequate to accurately read instruments and record monitoring and verification results.
  • Review maintenance records and visually verify that lighting equipment is protected as needed.

d. Ventilation

  • Ventilation provides sufficient air exchange to control moisture and minimize condensation.
  • Ventilation systems are designed and constructed to prevent contamination (e.g., air flow into clean areas is not contaminated).
  • Ventilation systems are adequately maintained and cleaned.

d. Ventilation

  • Review ventilation maintenance and cleaning records and visually verify that there is appropriate air pressure (e.g., positive or negative), where necessary, to prevent contamination.
  • Check whether there is condensation that could negatively impact the safety of the commodity (e.g., dripping on food or food contact surfaces).
  • For livestock barns, review ventilation requirements and verify that maintenance records reflect air quality that supports maintenance of herd health.

e. Employee facilities

  • When present, the location and design of employee facilities (e.g., washrooms, lunch rooms and change rooms) do not contribute to or cause contamination of commodities or production areas.
  • An adequate means of hygienically washing and drying hands and personal protective equipment (e.g., boots) is provided (including wash basins and a supply of safe water).
    • The location of hand-washing and sanitizing stations does not contribute to or cause contamination of commodities.

e. Employee facilities

  • Review d records and visually verify that washrooms, lunch rooms, change rooms and personal protective equipment are properly located and maintained (e.g., hot water, hand-washing and drying equipment, functional lavatories) and do not contribute to or cause contamination of commodities.

5.3 Water, ice and steam

Outcome
  • Water, ice and/or steam that comes into contact with regulated commodities is safe for its intended use.
Rationale
  • Since water, ice and steam can be used for a variety of purposes (e.g., sanitation, hand washing, as an ingredient or processing aid), it is important that water be safe for intended use.
  • Water, ice and steam can be a source of biological, chemical or physical contaminants.
Water, Ice and Steam: Regulated Party Performance Criteria and Inspection Activities
Regulated Party Performance Criteria Inspection Activities

a. Water, ice and steam safety

  • Water, ice and steam that come in contact with commodities or commodity contact surfaces are safe for intended use (e.g., sea water used in rinsing and packing fish products, drinking water for animals).
  • There is no cross-contamination between safe and unsafe water supplies.
  • Safety of water must be confirmed using recognized methods at a frequency adequate to confirm its safety.
  • Where municipal sources are used, municipal test results may be accepted.

a. Water, ice and steam safety

  • Confirm that safe water is being used, such as:
    • municipal water; or
    • tested water with available test results.
  • If water is treated, confirm that any chemicals used are accepted for that use and that appropriate procedures are followed.
  • Review facility schematics and maintenance records to ensure there is no cross-contamination between safe and unsafe water supplies.

b. Water, ice and steam handling equipment

  • Equipment is designed, installed and maintained in a manner that will not jeopardize water safety.

b. Water, ice and steam handling equipment

  • Review facility schematics and maintenance records to confirm that equipment design, installation and maintenance does not jeopardize water safety.

5.4 Waste disposal

Outcome
  • Effluent and waste storage and disposal systems are designed, constructed and maintained to prevent contamination of regulated commodities, and the environment.
Rationale
  • 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 (e.g., 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 (e.g., trapping, venting) will prevent sewer gases, pests, micro-organisms or other contaminants from entering the establishment through the plumbing system.
Waste Disposal: Regulated Party Performance Criteria and Inspection Activities
Regulated Party Performance Criteria Inspection Activities

a. Waste storage areas and containers are identified, of suitable capacity, secured and cleaned to avoid attracting pests.

a. Review maintenance records and visually verify that waste containers are identifiable, secured and cleaned at regular intervals.

b. Waste disposal, including effluent lines, does not contaminate commodities, preparation areas or the environment.

b. Review maintenance records and visually verify that waste disposal does not contaminate commodity preparation areas (e.g., leakage and spillage).

c. Drainage and sewage systems are adequate for the volume and type of effluent being produced during normal processing and cleaning operations, and backflow is prevented.

c. Review maintenance records and visually verify that drainage and sewage systems are adequate for the volume and type of effluent and waste does not accumulate in handling areas.

  • Note any odours that are not characteristic of the commodity.

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

6.1 Receiving, transportation and storage

Outcome
  • If applicable, commodities (including inputs) and packaging materials are transported, received and stored in conditions that maintain integrity and prevent damage, spoilage and contamination.
Rationale
  • 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 negatively impacted if left at ambient or adverse temperatures and conditions for prolonged periods.
Receiving, Transportation and Storage: Regulated Party Performance Criteria and Inspection Activities
Regulated Party Performance Criteria Inspection Activities

a. Conveyances used for the transport of commodities:

  • are clean and protect the commodity from contamination, damage and deterioration (including temperature and humidity controls); and
  • are not being used to transport any material or substance that might cross-contaminate or adulterate the commodity.

a. Review records and visually confirm that:

  • conveyances are cleaned and protect the commodity;
  • incompatible commodities are not transported or stored together unless there are appropriate controls (e.g., separation); and
  • conveyances that are used for multiple incompatible purposes are cleaned between uses.

b. When required, commodity temperature and humidity controls (e.g., refrigeration or freezing) are maintained (e.g., not left out at ambient temperatures for prolonged periods).

b. Review records and visually confirm that commodities that require environmental control are transported and stored at an appropriate temperature and humidity and there is no risk of contamination.

  • Note if any commodities are, or have been, left out in adverse conditions which could impact safety, health or quality (e.g., freezing, thawing or sweating).

c. Conveyances are loaded, arranged and unloaded in a manner that prevents damage and contamination of the inputs and/or finished commodities.

c. Confirm by reviewing records and visually verify that inputs and packaging materials are managed to minimize damage and maintain integrity at receiving and shipping.

d. Storage areas allow the:

  • separation of commodities and other materials, including returned commodities;
  • protection of the commodity from contamination;
  • when required, control of temperature and humidity to prevent deterioration and spoilage; and
  • stock to be rotated to maintain suitability, quality and safety.

d. Review shipping records and visually verify that storage areas provide:

  • for separation, including return commodities;
  • protection of the commodity from contamination;
  • control of temperature and humidity when required; and
  • stock to be rotated to maintain suitability, quality and safety.

6.2 Animal transportation

Outcome
  • Animals are transported humanely, in accordance with regulatory requirements.
Rationale
  • Animals may be injured or may not reach their destination in a suitable condition, unless they are transported and handled humanely.
Animal Transportation: Regulated Party Performance Criteria and Inspection Activities
Regulated Party Performance Criteria Inspection Activities

a. Conveyances used for the transport of live animals, and animal handling and holding areas are designed to:

  • Provide adequate space and ventilation; and
  • Protect the animals from inclement weather.

a. Confirm through visual observation or reviewing records that:

  • animals are transported in natural positions; and
  • note if any animals are transported under adverse conditions (e.g., sweating, frost bite, panting).

b. Animals are handled, loaded, transported, unloaded and held in a manner that prevents undue stress.

b. Confirm by records review records and visual observation that animals are loaded with appropriate spacing.

c. Animal requirement for rest, food and water are met.

c. Confirm by records review records and visual observation that there is a schedule for rest, feeding and water and it is being followed.

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

7.1 Traceability and control

Outcome
  • Commodities are adequately identified to enable removal from the marketplace or other movement restrictions.
  • Non-compliant commodities are effectively controlled by preventing entry into commerce, rapid retrieval if distributed and disposal, as appropriate.
  • CFIA is notified where required by the Act or regulations of a non-compliant product.
Rationale
  • Identifying and controlling implicated commodities quickly and effectively is crucial for protecting the general public, plants, animals and the environment from preventable risks.
Traceability and Control: Regulated Party Performance Criteria and Inspection Activities
Regulated Party Performance Criteria Inspection Activities

a. The traceability and control system must be able to:

  • identify sources of inputs (e.g., ingredients) for the implicated commodity;
  • stop any further distribution and sale;
  • trace commodities (including by-products and cross-contaminated products, if implicated) to the next point of distribution;
  • contact customers and the CFIA;
  • retrieve the implicated commodity, including segregation if needed; and
  • maintain accurate traceability records in accordance with applicable standards.

a. Review records to identify any previous recalls and disease/pest control activities and confirm that the commodity was effectively recalled/controlled (quantity distributed and returned) and disposed of or handled as per procedures.

  • Determine if the cause of the recall and/or control action was identified and if this information was used to make adjustments to prevent recurrence.
  • If the control and/or traceability system has been periodically tested, review training records to determine effectiveness.
  • If appropriate, request a mock recall or simulation (e.g., disease outbreak).

7.2 Complaints

Outcome
  • Complaints related to diseases, pests, safety, product misrepresentation and animal transport are investigated to determine root cause and corrective actions are taken.
Rationale
  • Complaints from any source (e.g., consumers, primary producers, other industry members) are important indicators of possible deficiencies in the system or the possible presence of a contaminant, pest or disease. When the complaint handling system itself is deficient, it could result in failure to identify, control and mitigate risks.
Complaints: Regulated Party Performance Criteria and Inspection Activities
Regulated Party Performance Criteria Inspection Activities

a. Complaints and reports are documented and investigated by the regulated party to determine if there is non-compliance with regulatory requirements.

a. Review complaint records to determine if there are any trends that may require further investigation.

b. Corrective action is taken for non-compliance, to address:

  • the implicated commodity (including cross-contaminated commodity);
  • any changes required to processes or procedures to prevent recurrence; and
  • The requirement to further report to CFIA if the presence of a pest/disease is suspected.

b. Where complaints are substantiated, confirm that the root cause was determined and whether this information was used to prevent recurrence.

  • Verify that the corrective action taken has addressed the issue.

Annex C: Basic steps for the inspection of the permission 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:
      • changes in activity (e.g., operation has begun exporting);
      • triggers ( e.g., recalls, complaints, clinical signs);
      • company records, previous inspection reports and compliance history (e.g., repeated non-compliance);
      • any element of the PCP that is a priority (e.g., Element 1: Process and product control); and
      • 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, photographsFootnote 17 and copies of documents may also be gathered.

  1. Opening meeting
    • Introduce all participants (CFIA and regulated party) present and explain CFIA 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 PCP 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.
    • 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.

    Consider:

    • harbourage of pests;
    • environmental contaminants;
    • uncontrolled access points to preparation areas; and
    • deterioration in condition of facilities (e.g., buildings, and external structures such as fences) that could 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.

    Consider:

    • 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); and
    • waste management (liquid and solid).

    Document all potential non-compliance based on 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. Confirmation of the scope of inspection

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

  4. Conduct inspection

    Review records

    Review the PCP and records for the elements that fall within the scope of the inspection. The number and type 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:

    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 effective; and
    • 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; and
    • 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 PCP.

    Any records supporting the PCP 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 PCP 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, go to subsection e.

  5. Determine compliance and manage non-compliance

    Determine the risk posed by the non-compliance for each element, and whether regulatory response is needed.

    All non-compliance must be corrected by the regulated party.

    Where there is a risk of a severe impact on human, animal or plant health, or environment or economic or trade is observed, take the following steps:

    • communicate and discuss the issue with the regulated party's key contact to determine if further action is required; and
    • 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; and
      • initiate compliance or enforcement action (e.g., seize and detain product, stop production, initiate recall) if the commodity is not effectively controlled.
  6. Completion of inspection report

    The inspection report includes the inspection findings, non-compliances observed and actions taken.

    Documentation of the records reviewed includes the following:

    • information that identifies the specific records assessed; and
    • 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; and
    • 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:

  • discuss overall findings of the inspection, including any trends;
  • report any incidents of non-compliance;
  • provide clarification to any questions or concerns;
  • obtain the regulated party's commitment to address non-compliance, and note the proposed interim measures, if any;
  • inform the regulated party of any lab samples submitted for analysis and when the results are expected;
  • provide a copy of the inspection report and associated documents if completed, or note when they will be available;
  • discuss next steps, including timelines for completing corrective actions; and
  • advise of any follow-up activities or inspections.

Step 4: Conduct a follow-up inspection

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

  • a written request for an extension is submitted, with reasons and the proposed new completion date; and
  • human, animal, or plant health or the environment is not compromised.

When reviewing corrective actions:

  • confirm what actions were taken and why, the appropriateness of the actions, including disposition of the affected commodity;
  • review any records that demonstrate the effectiveness of the corrective actions;
  • observe the changes, if any; and
  • review any amendments to the PCP.

If the corrective actions have been implemented effectively, close the non-compliance in the inspection report.

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

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 PCP 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 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, if appropriate.

  4. Seizure and detention

    Seizure and detention allow the CFIA to control anything that the inspector has reasonable grounds to believe contravenes 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 AMPs 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 permission 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. 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.

  8. 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 requirement to carry out effective corrective actions and further enforcement action is being considered.

  9. Publication of non-compliance

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

  10. Disposal/ Destruction

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

  11. 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 contravention 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 CFIAA, the CFIA may apply to a court of competent jurisdiction for an interim injunction. Once the SFCA is fully in force, the Minister will be able to apply for a permanent injunction.

  12. Recall

    Recalling a product is appropriate when there are reasonable grounds to believe the regulated product poses a risk to 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 CFIAA, 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."

  13. Actions taken with regard to permissions

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

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

  14. 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 regulatory requirements, without having to immediately resort to the suspending or cancelling of permissions or to instituting court proceedings;
    • provide an avenue other than the penalties section of an Act for encouraging compliance with requirements;
    • allow for regulated parties to request a review of the facts by the Canada Agricultural Review Tribunal, or to the Minister; and
    • 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 (HOAA) and the Plant Protection Act (PPA) currently contain provisions for AMPs. Monetary penalties may be imposed 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.

  15. 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.

  16. Treatment order

    The CFIA can order the treatment of a commodity to mitigate the risk of a pest or disease. Treatment may also be combined with disposal to mitigate pest escape risk while waiting for disposal to occur.

  17. 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:

  • Online;
  • By email;
  • By mail;
  • By telephone; and
  • By fax.

Submitting a complaint

Complainants should complete a CAO intake form. The form is available on CFIA's website.

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 employee and their management team the opportunity to resolve complaints before they escalate. More information regarding this approach is available on the CFIA's website: Complaints, Comments and Compliments.

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:

  • is not satisfied with the service provided by CFIA staff;
  • perceives that undue delays have been caused by CFIA staff;
  • believes that the CFIA has made an error;
  • disagrees with CFIA decisions (e.g., those decisions relating to permission, registration, permits, orders, inspection results, seizure, product identification and other items); or
  • disagrees with CFIA regulations, policies and procedures.

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 prior to the complaint submission 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 HOAA or PPA;
    • a request for re-inspection;
    • an appeal of decisions made under AAAMPA;
    • a food complaint from a consumer (food safety or non-food safety);
    • dissatisfaction with a Board of Arbitration decision for fresh fruit and vegetables; and
    • 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 or under CFIA investigation for potential prosecution. 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 Actand 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:

  • asking the Agency technical specialists to provide their perspective on the issue;
  • reviewing relevant technical documents provided (e.g., procedures, policies, regulations, phytosanitary certificates, notices of removal, inspection files etc.); and
  • meeting with Agency staff to explore any options for addressing the issue.

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 the 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 observations could range from the identification of policies or procedures that need to be updated or clarified to areas that could benefit from improved service delivery.

Timeframes

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

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

Records Management

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

The CAO will share information about the complaint file with the CFIA on a "need to know" basis, meaning that information provided to the CAO by the complainant will not be shared for purposes other than to conduct the complaint review. 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 Lines and support consistent interpretation of terminology where the meaning of the term is restricted for the purposes of this model. Terms not addressed in the glossary are set out in legislation and, if not present, the dictionary definition applies.

Alternative service delivery
(Diversification de mode de prestation de service)
An arrangement that the CFIA enters into with another party to deliver services or programs, where appropriate.
Biocontainment
(Bioconfinement)
Application of measures and procedures implemented to prevent the spread and release of pests, diseases and contaminants from a site.
Biosecurity
(Biosécurité)
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).
CFIA oversight
(Surveillance de l'ACIA)
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.
Commodity
(Produit)
Any products and/or things regulated under any Act or regulations administered or enforced by the CFIA.
Competent authority
(Instances compétentes)
A government agency or department having jurisdiction to perform legislated functions
Compliance promotion
(Promotion de la conformité)
Any activity that informs, motivates and encourages compliance with the CFIA's regulatory requirements.
Contaminant
(Contaminant)
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
(Mesure de contrôle)
Any action or activity that can be used to prevent, manage or eliminate a hazard or mitigate the risk.
Corrective action
(Mesure corrective)
The steps that a regulated party takes to address non-compliance, which includes controlling affected product, conducting root cause analysis and modifying procedures to prevent recurrence.
Cross-contamination
(Contamination croisée)
A situation that occurs when hazards are transferred.
Distribution premise
(Lieu de distribution)
A warehouse or other specialized location that is stocked with commodities or things to be redistributed to retailers, wholesalers or directly to consumers.
Employee
(Employé)
A person who is conducting activities for and/or on behalf of an establishment or a premises.
Establishment
(Établissement)
Any place, including a conveyance, where a commodity is produced/manufactured, prepared, stored, transported, packaged or identified (including labelling).
Exporter
(Exportateur)
Any person who prepares, sells or trades commodities for export from Canada to another country.
Hazard - Biological
(Danger biologique)
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
(Danger chimique)
A chemical substance that poses a danger to human, animal or plant health or the environment.
Hazard - Physical
(Danger physique)
Any foreign material that is not normally found in a commodity and that poses a danger to human, animal or plant health or the environment.
Importer
(Importateur)
Any person in Canada who imports commodities into Canada.
Inputs
(Intrants)
Any incoming materials used to prepare, process, or produce regulated commodities.
Monitoring
(Surveillance)
The act of conducting a planned sequence of observations or measurements of control parameters to assess whether a control measure is under control.
(Codex)
Permissions
(Autorisations)
Official consent granting legal authorization to a regulated party to conduct specified activities (e.g., permits, certificates, licences and registrations).
Pest
(Ravageur)
Any species, strain or biotype of organism injurious to or impacting on human, animal or plant health or the environment (including prions).
Premises
(Lieux)
A geographically defined place that includes lands, establishments, buildings and facilities (e.g., greenhouses, corrals, assembly centre ).
Prepare or Produce
(Préparer ou Produire)
Includes to grow, process, treat, preserve, handle, test, grade, package, code, collect, hatch or slaughter or to do any other activity in respect of the regulated commodity.
Preventive control plan
(Plan de contrôle préventif)
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
(Producteur primaire)
A person who works with natural resources to grow, harvest or extract primary products (i.e., agriculture, fishing, aquaculture, forestry).
Private certification scheme
(Plan de certification du secteur privé)
Formal, documented systems that are developed and administered by the private sector that prescribe methods to obtain specific objectives and outcomes, and typically involve audit and certification
Product identification
(Identification de produit)
Any document or device associated with and/or attached to a product that allows the CFIA to distinguish that product from another (e.g., labels, tags, tattoos, stamps, microchips).
Regulated area
(Zone réglementée)
A designated area (e.g., compartments and zones) subject to regulatory control.
Regulated party
(Partie réglementée)
A person (including an individual, corporation, partnership or organization) who is subject to the Acts and regulations administered by the CFIA.
Risk-based oversight
(Surveillance axée sur le risque)
A system that uses risk factors, to prioritize and manage inspection activities.
Sanitation
(Assainissement)
Cleanliness appropriate to the operations of the regulated party.
Systems-based approach
(Approche axée sur un système)
An integrated, flexible, multi-faceted approach to analysing and managing risk that considers the actions of all of the steps or processes and controls that make up commodity production or preparation.
Validation
(Validation)
Obtaining evidence that a control measure or combination of control measures, if properly implemented, is capable of controlling the hazard to a specified outcome.
(Codex)
Verification
(Vérification)
The application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine whether the control measure is or has been operating as intended.
(Codex)
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