Improved Food Inspection Model
Revised Draft

Annexes

• Annex A: Details for issuing, renewing and amending a licence
• Annex B: Elements of the preventive control plan: outcomes, performance criteria and inspection activities
• Annex C: Basic inspection steps and draft inspection report
• Annex D: Compliance and enforcement: range of possible responses
• Annex E: System performance: preliminary draft indicators
• Annex F: Exemptions
• Annex G: Draft glossary of terms

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

The following provides additional information on the approach for licensing. More detailed procedures will be developed.

Applying for / obtaining a licence

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

1. Application status (applicant would check one that applies)
   • new
   • amendment
   • renewal
2. Business activities information (applicants would check all that apply)
   • operations importing food with storage / distribution facilities
   • operations importing food without storage / distribution facilities
   • operations exporting food with storage / distribution facilities
   • operations exporting food without storage / distribution facilities
   • operations preparing food for interprovincial trade
   • operations preparing food for export
   • operations not falling within one of the above categories
3. Contact and legal information (all fields must be completed)
   • business name and operating name
     • copies of the applicant’s articles of incorporation or provincial registration, if any
   • legal (civic) address (physical location) in Canada
     • all physical location(s) covered under the licence in Canada
   • mailing address (if different from legal address)
   • address where records will be available (if different from legal address)
   • fax/telephone number, email address
   • name of operator (licence holder)
   • name of primary contact person at each physical location
   • name of emergency contact
4. Business status (applicants would check one that applies)
   • active
   • inactive
   • seasonal
   Note: If an applicant’s food business is a seasonal operation, then he or she would be required to notify the CFIA of the planned start and end date for operations.
5. Hours and days of operation
   • applicant would enter the hours of operation
   • applicant would enter days of operation
6. Commodity information (applicants would check all that apply)
   • alcoholic beverages
   • non-alcoholic beverages
   • confectionery, sweeteners, snack foods (containing or not containing nuts), desserts
   • dairy
   • egg and egg products
   • fats and oils
   • fish and seafood products (including bivalve molluscs)
   • food chemicals (for example, additives, processing aids)
   • fresh fruit
   • fresh vegetables
   • grain-derived foods (for example, breakfast cereal, bread and bakery, pasta)
   • honey and honey products
   • infant foods
   • maple products
   • meat and poultry
   • multiple/mixed foods (for example, pizza, frozen meals, sandwiches)
   • nuts, grains, seeds
   • processed fruit products
   • processed vegetables
   • spices, herbs, flavours, condiments, dressings
   • other (please specify)
7. Business size
   • number of employees (ranges to be provided as options—applicants would check one that applies)
   • annual volume of production or importation or exportation (ranges to be provided as options—applicants would check one that applies)
8. Food commodity type, handling information and volumes (applicants would check all that apply)
   • ready-to-eat
     • pathogen reduction step
     • control of contamination
   • not ready-to-eat
   • importation
     • prepackaged foods only
     • foods for packaging, labelling, re-labelling, further processing
   • number of different types of food commodity (ranges to be provided as options—applicants would check one that applies)
   • estimated annual volume of production, importation or distribution (ranges to be provided as options—applicants would check one that applies)

Amendments and renewals

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

Process for issuing a licence

Step 1: Application review

1. Upon receipt of the licence application, the CFIA would review it and, if an issue were identified, document the relevant facts.
   
   The Minister (or delegate) could refuse to issue a licence if the applicant
   • does not meet conditions of licensing
   • has submitted inaccurate information
   • has provided false or misleading information, documents or records
   • engaged in deceptive practices in order to obtain a licence
2. The Minister (or delegate) would review the facts before rendering a decision. If required, expert advice would be sought to ensure that the licensing criteria were applied consistently.
   • A pre-licensing inspection may be required for high-risk activities and would be a priority for first-time applicants. Notifications would be sent if a pre-licensing inspection were required.

Step 2: Communication of decision

1. If a licence were to be issued, the licence holder would be notified of his/her initial priority level, and provided the Statement of Rights and Service for Producers, Consumers, and Other Stakeholders.
2. If a licence were to be refused, a written notice of refusal would be sent, with the justification for the refusal.
3. The applicant could request a review of the refusal and present facts to support the request.

Step 3: Decision review

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

Process for suspending a licence

Step 1: Initiation

1. The inspector would identify an issue and gather facts to support a suspension.
2. The inspector would inform his or her management of the facts.
3. The licence holder would receive a report of the inspection and would be provided an opportunity to remedy the non-compliance⁵.

Step 2: Evaluation

1. If the non-compliance were not addressed, the licence could be suspended. The Minister (or delegate) would review the file and possibly seek expert advice, as appropriate, to ensure that the suspension criteria were being applied consistently⁶.
2. The Minister (or delegate) would render a decision.

Step 3: Communication of decision

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

Step 4: Lifting of a suspension

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

Process for cancelling a licence

Step 1: Initiation

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

Step 2: Evaluation

1. The Minister (or delegate) would review the file and seek expert advice, as appropriate, to ensure that the cancellation criteria had been applied consistently.
2. The Minister (or delegate) would be available to meet to discuss findings, explain the process, and give the licence holder an opportunity to respond.
3. The Minister (or delegate) would render a decision.

Step 3: Communication of decision

1. The licence holder would receive written notification of the decision. If the licence were to be cancelled, this would include the reasons for the decision to cancel the licence.
2. The licence holder could request a review of the cancellation and present facts to support the request.

Step 4: Decision review

The CFIA is currently reviewing options for a recourse mechanism that would be made available to licence holders after a decision to cancel their licence.

Annex A.1: Draft licence application form

PDF (327 kb)

Description for Draft licence application form

Annex A.1 is an image of the draft license application form proposed by the improved food inspection model. The application form is divided into parts A, B, C and D. The form requires the following information be provided starting at the top of the form:
Under "Application status" an applicant would check one that applies of the following

• new license
• amendment
• renewal – no changes to profile
• renewal – changes to profile

Under "Part A: Business activities" an applicant would check all that applies of the following

• operations importing food with storage/distribution facilities
• operations importing food without storage/distribution facilities
• operations exporting food with storage/distribution facilities
• operations exporting food without storage/distribution facilities
• operations preparing food for interprovincial trade
• operations preparing food for export trade
• operators that do not fall within one of the above categories

Under "Part A: Name of applicant: Contact and legal information" an applicant would need to complete all of the following fields

• business and operating name (if different)
• civic address (physical location)
  • all physical location(s) covered under the licence
• mailing address (if different from civic address)
• address where records would be available (if different from civic address)
• telephone and facsimile number, email address
• name of operator (licence holder)
• name of primary contact person

The applicant would also be asked to provide emergency contact information.

Under "Part A: Business status" an applicant would check one that applies of the following

• active
• seasonal
• inactive
  • if season, the applicant would need to provide the CFIA the planned operation start and end date

The applicant would also be asked for the days and hours of operation and to provide information on the number of employees.

Under "Part B: Food commodity information" an applicant would check all that apply of the following:

• alcoholic beverages
• non-alcoholic beverages
• confectionery, sweeteners, snack foods, desserts
• dairy
• shell egg and processed egg products
• fats and oils
• fish and seafood products (including bivalve molluscs)
• food chemicals (for example, additives, processing aids)
• fresh fruit
• fresh vegetables
• grain-derived foods (for example, breakfast cereal, bread and bakery, pasta)
• honey and honey products
• infant foods
• maple products
• meat and poultry
• multiple/mixed foods (for example, pizza, frozen meals, sandwiches)
• nuts, grains, seeds
• processed fruit
• processed vegetables
• spices, herbs, flavours, condiments, dressings
• other (please specify)

Under "Part B: Food commodity type, handling information and volumes" an applicant would check all that apply of the following:

• ready-to-eat, including
  • pathogen reduction step
  • control of contamination
• not ready-to-eat
• importation, including
  • pre-packaged foods only (no further processing or repackaging)
  • foods for packaging, labelling, re-labelling, further processing
• the number of different types of food commodities
• the estimated annual volume of production, importation or distribution

"Part C: Management commitment statement" would need to be completed in order to submit application. It would confirm the company’s commitment to

• notify the CFIA when food commodities not meeting food safety requirements are in the marketplace, and
• update business profile when changes are made that impact the information provided in the licence application.

It would also confirm that key personnel employed by the food business operation are trained and have the knowledge necessary to prepare safe and compliant food.

Under "Part D: Fees and payments" applicant could make payment by credit card or cheque. An applicant is reminded that the submission of a completed application and the prescribed fee does not authorize the applicant to engage in food preparation or import, export or interprovincial trade activities until the license is received.

The form ends with space for the applicant to sign and date underneath a statement acknowledging that the applicant

• certifies that the information provided is, to the best of their knowledge, true and correct;
• authorizes the CFIA to verify any information pertaining to the application; 
• understands that any false or misleading statements made would result in refusal of the application.

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

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

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

Element 1: Product and process outcomes and performance criteria for licence holders

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

1.1 Process control outcome: performance criteria

a. Incoming ingredients and raw materials

• identification of incoming ingredients, with written specifications, if
  • there is a potential food safety concern
  • an ingredient is critical to product composition and/or nutrition profile
• documented handling procedures for ingredients to prevent degradation

b. Product formulation and specifications

• written formula for each food commodity that is being prepared
• written specifications for each final food commodity
• food additives and chemicals used are permitted for use in the food commodity

c. Processing

• written description of
  • processing steps (for example, mixing records), associated control measures and critical limits
  • food commodity movement (for example, process flow diagram)
  • food commodity changeover procedures
• critical limits are validated using scientific data
• imported food commodities are prepared under conditions that are comparable to Canadian requirements

1.2 Product control outcome: performance criteria

a. Packaging

• There is a written specification for packaging materials that come in contact with food.
• All packaging materials are suitable for the intended use.

b. Labelling

• The information on the label is complete, truthful and not misleading, and accurately represents the content of the food commodity.

c. Finished Product

• The finished food commodity is evaluated for compliance with prescribed requirements.

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

1.3 Import control outcome: performance criteria

• Control measures and sourcing are done to ensure that food 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 third-party audits by internationally-recognized accreditation or certification,
  • auditing 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.

1.4 Export control outcome: performance criteria

• Documentation of the exported food commodity and corresponding foreign country import requirements.
• 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 based on system compliance, the licence holder would notify the CFIA when a food shipment is rejected because of evidence of a food safety or public health concern in the importing country.
• Control and segregation of food commodities destined for export that do not meet Canadian requirements and are not permitted to enter the Canadian marketplace.

Element 1: Inspection activities for process and product controls

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

Inspection activities for sub-element 1.1: Process controls

• Confirm that the preventive control plan addresses the general requirements and performance criteria for this sub-element.
• Follow general inspection step 2 in Annex C.

a. Incoming ingredients and raw materials

• Review records to determine if there is potential for any incoming ingredients and/or raw materials to contain allergens or other food hazards. Adjust the scope of the inspection, if necessary.
• Check whether raw materials or incoming ingredients that could contain allergens or other food hazards are properly identified and segregated.
• Observe how raw materials are received to verify that there is no cross-contamination or degradation.

b. Product formulation and specification

• Review the product listing of all food commodities and adjust the scope of the inspection to incorporate higher-risk processes.
• Confirm that the current formula is available for each food commodity.
  • Assess any changes to product formulations for any impact on label accuracy and food safety.
• Confirm that any food additives are permitted for use in the particular food.

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 and note any product substitutions and appropriate adjustments to processing or labelling,
  • ingredients and raw ingredients are accurately measured and blended, and
  • processing controls are monitored and critical limits are met.
• Review process validation records to confirm that processes and parameters are current.
• Observe product and process flow for potential cross-contamination.
• Observe that procedures are being followed for the use of rework and product changeover and that there is no cross-contamination.

Inspection activities for sub-element 1.2: Product controls

• Confirm that the preventive control plan addresses the general requirements and performance criteria for this sub-element.
• Follow general inspection step 2 in Annex C.

a. Packaging

• Confirm food packaging material meets the requirement of the Food and Drug Regulations, Part B, Division 23, Food Packaging Materials.
• Observe the packaging process to verify that contaminated, damaged or defective packaging material is not used, and that the food commodity is not damaged or contaminated.

b. Labelling

• Select a food commodity or commodities to verify that labels accurately represent content. For example:
  • foods containing priority allergens are labelled;
  • nutrition labelling requirements are met;
  • all nutrition claims are factual, not false and not misleading; and
  • any other labelling requirements are met, including mandatory information, type size, bilingual requirements, net quantity declarations, ingredient declarations, health or product claims.

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, to confirm that it is in compliance with regulatory requirements.

Inspection activities for sub-element 1.3: Import controls

• Review imported product records to determine
  • what food commodities were imported and from where,
  • the results of control measures and sourcing to ensure that food commodities meet Canadian requirements (for example, certificates of analysis, audit results, competent authority certification), and
  • if any food commodities were rejected and, if so, what was the issue and what corrective action was taken.

Inspection activities for sub-element 1.4: Export controls

• Review exported food shipment records to determine
  • to what countries shipments were conveyed, and
  • if any shipments were rejected and, if so, what was the issue and what corrective action was taken.

Element 2: Sanitation and pest control outcomes and performance criteria for licence holders

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

2.1 Sanitation outcome: performance criteria

• There is a schedule for cleaning and/or sanitizing, which includes the concentration of chemicals to be used, and temperature and pressure requirements (if applicable), for
  • the establishment, including preparation and storage areas;
  • equipment; and
  • food contact surfaces, including containers and utensils.
• Equipment used for cleaning and/or sanitizing is capable of delivering the requirements of the sanitation program.
• Cleaning and/or sanitizing is carried out in a manner that does not contaminate food or packaging materials during or after cleaning and/or sanitizing.
• Effectiveness of cleaning and/or sanitation is assessed visually or through environmental sampling.
• Food contact surfaces are free from the accumulation of dust, dirt, food residue and other debris.
• Environmental sampling is conducted in accordance with Health Canada 2011 Policy on Listeria monocytogenes in Ready-to-Eat Foods.

2.2 Pest control outcome: performance criteria

• There is a program for pest control and removal.
• There is a schedule for monitoring for evidence of pest activity.

2.3 Chemicals outcome: performance criteria

• A listing of chemicals or specification sheets for chemicals used in sanitation and pest control is maintained.
• The use of chemicals does not contaminate food, equipment, utensils or food contact surfaces.
• Chemicals are suitable for their intended use.
• Chemicals are properly stored, controlled, and labelled.
• Chemicals are dispensed and handled by trained personnel.

Element 2: Inspection activities for sanitation and pest control

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

Inspection activities for sub-element 2.1: Cleaning and sanitation

• Confirm that the preventive control plan addresses the general requirements and performance criteria for this sub-element.
• Follow general inspection step 2 in Annex C.
• Confirm cleaning and sanitizing is being done according to the procedures and schedule.
  • Review records
    • Review the licence holder’s procedures for verifying that clean in place and cleaning in general is effective.
    • Review procedures for verifying that equipment is functioning as intended.
    • Check whether any issues or deviations have been identified and note what actions were taken.
    • Review any results of environmental sampling, if applicable.
  • Observe responsible employees performing the activity
    • Verify that floor sprays are not contaminating food contact surfaces, and that there are no other sources of cross-contamination.
    • Confirm temperature, chemical concentrations and pressure is being verified.
• Visually verify that cleaning procedures are effectively removing dirt and debris.
  • Look for evidence of dirt, debris and food material on food contact surfaces, including containers and utensils.
• Take environmental samples—if necessary to confirm observations—for ready-to-eat food preparation areas.

Inspection activities for sub-element 2.2: Pest control

• Confirm that the preventive control plan addresses the general requirements and performance criteria for this sub-element.
• Follow general inspection step 2 in Annex C.
• Visually verify that there is no evidence of pests—particularly in food processing, 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.

Inspection activities for sub-element 2.3: Chemicals

• Confirm that the preventive control plan addresses the general requirements and performance criteria for this sub-element.
• Follow general inspection step 2 in Annex C.
• Confirm there is a listing of chemicals used (including pesticides/rodenticides), or specification sheets available.
  • Chemicals used on food or food contact surfaces must meet the requirements of the Food and Drugs Act or Pest Control Products Act, as applicable.
• Check that chemicals are stored separately from food, clearly identified and dispensed with utensils that are not used for food preparation.
• Check that label instructions for any chemicals used are being followed.

Element 3: Hygiene and employee training outcomes and performance criteria for licence holders

The following performance criteria would have to be addressed by the licence holder to achieve the hygiene and employee training outcomes (3.1 and 3.2).

3.1 Hygiene outcome: performance criteria

• Effective biosecurity practices are in place, including
  • controlled access
  • employee facilities, hand-washing and sanitizing stations
  • use of sanitary clothing and footwear
• Hygienic practices are in place, including
  • proper hand-washing or use of sanitizers/gloves
  • rules for employee conduct
  • precautions for personnel with open wounds or a communicable disease

3.2 Employee training outcome: performance criteria

• A written description of training requirements for employees responsible for activities under the preventive control plan is maintained.
• Employees are trained to carry out the range of tasks and duties they are required to perform.

Element 3: Inspection activities for hygiene and employee training

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

Inspection activities for sub-element 3.1: Hygiene

• Confirm that the preventive control plan addresses the general requirements and performance criteria for this sub-element.
• Follow general inspection step 2 in Annex C.
• Confirm that the biosecurity practices are in place.
• Verify that biosecurity practices are being followed.
  • Movement of employees and access of visitors is controlled.
  • Footbaths and hand dips, if used, are properly maintained.
  • Any required clothing—including gloves, hair coverings, and footwear—is maintained in a sanitary manner.
  • Employee hand-washing facilities are available and clean.
• Observe employee behaviours occurring in food preparation areas.
  • Employees are washing hands when required (for example, when returning to the processing area).
  • Personal objects are prevented from falling into food.
  • Unhygienic practices, such as spitting, and use of tobacco, chewing gum, and consumption of food are not occurring.
• Confirm that employees handling food do not have open wounds or exhibit signs of having a communicable disease.

Inspection activities for sub-element 3.2: Employee training

• Confirm that the preventive control plan addresses the general requirements and performance criteria for this sub-element.
• Follow general inspection step 2 in Annex C.
• Review training records and check that employees are following procedures when carrying out duties and responsibilities.
• 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
  • proper handling of food commodities and ingredients (for example, temperature control, segregation of food commodities)
  • personal hygiene
  • equipment maintenance and calibration
  • general sanitation and cleanliness
• Confirm that employees receive ongoing training to maintain current specialized knowledge; such as, knowledge of control measures and critical limits or regulatory requirements.

Element 4: Equipment design and maintenance outcomes and performance criteria for licence holders

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

• All equipment, utensils, containers, and controlling and measuring devices used in food preparation and storage are
  • used only for the intended purpose,
  • functioning as intended,
  • maintained in a good state of repair,
  • cleanable, and
  • properly stored.
• Controlling devices used in the preparation of food are calibrated and maintained to ensure measurement accuracy and effectiveness.

Element 4: Inspection activities for equipment design and maintenance

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

• Confirm that the preventive control plan addresses the general requirements and performance criteria for this sub-element.
• Follow general inspection step 2 in Annex C.
• Confirm that equipment is being used as per procedures and review maintenance records, if necessary.
• Confirm that equipment is being calibrated according to schedule.
• Check that equipment, containers and utensils are in good repair (for example, check for rust, peeling paint, leaking lubricants).

Element 5: Physical structure and maintenance outcomes and performance criteria for licence holders

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

5.1 Outside premises and surroundings outcome: performance criteria

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

5.2 Buildings outcome: performance criteria

a. Exterior building structures

• The exterior of the building is maintained to prevent entry of pests and contaminants.

b. Interior building structures

• Floors, walls and ceilings are
  • cleanable
  • made of materials that will not contaminate food
  • in good repair
• In food preparation areas
  • floors are constructed and maintained to permit adequate drainage
  • glass, where breakage may contaminate food, is properly protected

c. Hygienic flow and separation

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

d. 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 food is properly protected.

e. Ventilation

• Ventilation provides sufficient air exchange to control moisture and minimize condensation.
• Ventilation systems are designed and constructed so that air flow into clean areas is not contaminated.
• Ventilation systems are adequately maintained and cleaned.

f. Employee facilities

• The location and design of employee facilities such as washrooms, lunch rooms and change rooms do not contribute to or cause contamination of food or food processing areas.
• An adequate means of hygienically washing and drying hands is provided (including wash basins and a supply of safe water).
  • The location of hand-washing and sanitizing stations in processing areas does not contribute to or cause contamination of food.

5.3 Water, ice and steam outcome: performance criteria

a. Water, ice and steam safety

• Water, ice and steam that come in contact with food commodities or food contact surfaces meet safety requirements as defined in Health Canada’s Guidelines for Canadian Drinking Water Quality – Summary Table or are safe for use (for example, sea water used in rinsing and packing fish products).
• 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.

b. Water, ice and steam handling equipment

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

5.4 Waste disposal outcome: performance criteria

• Waste storage areas and containers are identified, of suitable capacity and cleaned to avoid attracting pests.
• Waste disposal, including effluent lines, do not contaminate food or food preparation areas.
• 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.

Element 5: Inspection activities for physical structure and maintenance

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

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

• Confirm that the preventive control plan addresses the general requirements and performance criteria for this sub-element.
• Follow general inspection step 2 in Annex C.
• Visually verify if there are any sources of external contamination (for example, build up of garbage, smoke or fumes from neighbouring facilities).

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

• Confirm that the preventive control plan addresses the general requirements and performance criteria for this sub-element.
• Follow general inspection step 2 in Annex C.

a and b. Exterior and interior building structures

• Review maintenance records for building interior and exterior, including the air filter replacement records.
• Check that floors, walls and ceilings are made of non-porous materials that will withstand cleaning, and that floors are draining properly.
• Check that glass is properly protected in places where breakage could contaminate food.
• Confirm that
  • openings to exterior areas are protected or effective control measures are in place;
  • air intakes 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 leakage.

c. Hygienic flow and separation

• Confirm that incompatible operations are separated by physical or other means (for example, sequencing of food commodities to prevent introduction of allergens).

d. Lighting

• Verify that lighting is adequate to accurately read instruments and record monitoring and verification results.

e. Ventilation

• Verify that there is positive pressure in food preparation areas, where necessary, to prevent contamination.
• Check whether there is condensation dripping on food or food contact surfaces.

f. Employee facilities

• Confirm that washrooms do not open directly into food processing area.
• Check that washrooms, lunch rooms and change rooms are properly maintained (for example, hot water, hand-washing and drying equipment, functional lavatories).

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

• Confirm that the preventive control plan addresses the general requirements and performance criteria for this sub-element.
• Follow general inspection step 2 in Annex C.
• 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 chemicals⁸ used are accepted for that use (for example, a letter of no objection from Health Canada) and that appropriate procedures are followed. See the Guidelines for Incidental Additive Submissions

Inspection activities for sub-element 5.4: Waste disposal

• Confirm that the preventive control plan addresses the general requirements and performance criteria for this sub-element.
• Follow general inspection step 2 in Annex C.
• Check that waste disposal does not contaminate food preparation areas (for example, leakage and spillage).
• Verify that waste containers are identifiable and cleaned at regular intervals.
• Observe that waste does not accumulate in food handling areas.
• Note any odours that are not characteristic of the food being prepared.

Element 6: Receiving, transportation and storage outcomes and performance criteria for licence holders

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

• Conveyances, when used for the transport of food
  • are clean and protect the food from contamination, damage and deterioration, including refrigeration; and
  • are not being used to transport any material or substance that might contaminate or adulterate the food commodity.
• Food commodities in need of refrigeration or freezing are not left out at ambient temperatures for prolonged periods.
• Conveyances are loaded, arranged and unloaded in a manner that prevents damage and contamination of the incoming materials and/or finished food commodities.
• Food storage areas allow the
  • separation of food and other materials, including returned food commodities;
  • control of temperature and humidity to prevent deterioration and spoilage; and
  • stock to be rotated to maintain suitability, quality and safety.

Element 6: Inspection activities for receiving, transportation and storage

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

• Confirm that the preventive control plan addresses the general requirements and performance criteria for this sub-element.
• Follow general inspection step 2 in Annex C.
• Confirm, by visual observations or reviewing records, that food commodities that require environmental control are transported and stored at an appropriate temperature and humidity.
  • Note if any food commodities are left out at ambient temperatures, which would impact food safety or quality (for example, thawing or sweating).
• Visually confirm that incompatible food commodities are not transported or stored together unless there is an effective way to separate them.
  • Review records to confirm that conveyances that are used for multiple, incompatible purposes are cleaned between uses.
• Confirm that incoming ingredients and materials are managed to minimize spoilage or contamination at receiving.
• Review shipping records and visually verify that stock is being rotated.

Element 7: Traceability, recall and complaints outcomes and performance criteria for licence holders

The following performance criteria would have to be addressed by the licence holder to achieve the traceability, recall and complaints outcomes (7.1, 7.2 and 7.3).

7.1 and 7.2 Traceability and recall outcomes: performance criteria

• The traceability and recall system must be able to
  • identify sources of ingredients for the implicated food commodity,
  • stop any further distribution and sale,
  • trace food (including by-products, if implicated) to the next point of distribution,
  • contact customers and the CFIA, and
  • retrieve the implicated food.

For more information on food recall and emergency response.

7.3 Complaints outcome: performance criteria

• Complaints received by the licence holder are investigated to determine if there is non-compliance with legislative requirements.
• Corrective action is taken for non-compliance, to address
  • the implicated food commodity, and
  • any changes required to processes or procedures to prevent recurrence.

Element 7: Inspection activities for traceability, recall and complaints

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

Inspection activities for sub-elements 7.1 and 7.2: Traceability and recall

• Confirm that the preventive control plan addresses the general requirements and performance criteria for this sub-element.
• Follow general inspection step 2 in Annex C.
• Review records to identify any previous recalls and confirm that product was effectively recalled (volume distributed and volume returned) and disposed of or handled as per procedures.
• Determine if the cause of the recall was identified and if this information was used to make adjustments to prevent recurrence.
• Review test results if the recall system has been periodically tested.
• If appropriate, request a mock recall (for example, request a trace of a food commodity).

Inspection activities for sub-element 7.3: Complaints

• Confirm that the preventive control plan addresses the general requirements and performance criteria for this sub-element.
• Follow general inspection step 2 in Annex C.
• Review complaint records to determine if there are any trends that may require further investigation or if the scope of the inspection should be adjusted.
• Where complaints are substantiated, confirm that 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 inspection steps and draft inspection report

Details of basic inspection steps for inspectors

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

Step 1: Prepare for the inspection

a. Determine preliminary scope of inspection.

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

• changes in activity (for example, operation has begun exporting),
• triggers (for example, recalls, complaints),
• compliance history (for example, repeated non-compliance),
• any element of the preventive control plan that is a priority (for example, Element 1: Process and product control), and
• other elements that are not covered by a previous inspection.

Over time, the licence holder’s entire system should be inspected to verify compliance with all food safety and other regulatory requirements.

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

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

• Announced inspections provide inspectors with the opportunity to discuss and make prior 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 without prior notification. This may limit the scope of the inspection if certain personnel are not on site or certain activities are not being conducted.

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

• Where required, technical advice or guidance may be sought from system assessment officers or the Centres of Expertise.

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

Step 2: Conducting the inspection

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

a. Opening meeting

• introduce all CFIA staff present and explain each person’s role;
• outline the scope of the inspection, the process to be used, 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 licence holder on any changes to the inspection process and/or relevant regulations;
• confirm any changes to the information in the company profile;
• confirm any changes to the preventive control plan since the last inspection and modify the scope of the inspection, if needed;
• confirm the operation’s security and safety requirements (for example, hygienic measures, people flow restrictions, protective equipment, etc.);
• indicate that the operation will be advised of any changes to the scope during the inspection; and
• for inspections longer than one day, advise that an end-of-day meeting may be conducted to notify of any non-compliance(s) that may have been observed.

b. Initial walk-through inspection

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

• Observe general conditions of the facility (including conditions outside and inside).
• Focus efforts on identifying potential sources of contamination of the food commodity, food contact surfaces or equipment that require further consideration.

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

Consider:

• harbourage of pests
• environmental contaminants
• uncontrolled access points to preparation areas
• deterioration in condition of buildings that would permit entry of pests or other potential sources of contamination

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

Consider:

• conditions of floors, walls, ceilings (for example, clean, in a good state of repair)
• employee hygiene and work practices
• appropriate temperatures
• evidence of pest activity
• lighting (for example, protective shields in food processing areas, none broken)
• ventilation (for example, odours that are not characteristic of the process or food commodity, visible condensation)

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

c. Confirm the scope of inspection

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

d. Complete the inspection

Review records

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

Address the following for each element examined:

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

Review monitoring records to determine if

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

Review verification records to determine if

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

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

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

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

Observe activities and conduct interviews

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

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

• 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 section f. Inspection report. If non-compliance is identified, the level must be assessed.

e. Assign a level of non-compliance

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

There are three levels of non-compliance:

• critical: immediate impact on food safety or repeated serious non-compliance
• serious: potential impact on food safety
• technical: non-compliance with regulatory requirements that are not related to food safety

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

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

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

• Communicate and discuss the issue with the key contact to determine if further action is required.
• If further action is required, request immediate action to control affected food commodity and correct the issue.
  • Determine if all of the affected food commodity is under control.
  • Initiate compliance or enforcement action (for example, seize and detain product, stop production) if the product is not effectively controlled.

f. Inspection report

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

Documentation of the records reviewed includes the following:

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

Documentation of observations and interviews includes the following:

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

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

Step 3: Communicate the inspection results

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

At the closing meeting

• discuss overall findings of the inspection, including any trends
• report any incidents of non-compliance, and issue any corrective action requests
• provide clarification to any questions or concerns
• obtain licence holder’s commitment to address any corrective action requests issued, and note his/her proposed interim measures, if any
• inform the licence holder of any lab samples submitted for analysis and of 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 letting the CFIA know when corrective actions will be completed
• advise of any follow-up activities or inspections

Step 4: Conduct a follow-up inspection

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

• a written request for an extension is submitted, with reasons and the proposed new completion date
• food safety is not compromised

When reviewing corrective actions:

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

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

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

a. Continued or repeated non-compliance

The following table shows guidelines for compliance and enforcement action in the case of continued or recurring incidents of non-compliance.

Continued or repeated non-compliance	The inspector	The licence holder is required to
For a critical non-compliance	Initiates enforcement action (for example, suspension of licence)	Take immediate action to address the non-compliance, and control the affected food commodity, if necessary
For a serious non-compliance	Elevates to a critical corrective action request	Control the affected food commodity immediately and address the non-compliance to prevent reoccurrence
For a technical non-compliance	Initiates corrective action and appropriate enforcement (for example, AMPs, product seizure and detention)	Correct the affected food commodity

Annex C.1: Draft inspection report

PDF (205 kb)

Description for Draft inspection report

Annex C is an image of the draft inspection report form.

The draft inspection report form would auto-populate information from the license application and previous inspections.

Starting at the top, under "License holder: Business profile" the following business information would auto-populate:

• business name and operating name (if different)
• civic address (physical location)
• telephone/facsimile number, email address
• name of operator (licence holder)
• name of primary contact person
• food commodity information
• food commodity type and handling information
• date of last inspection
• non-compliance and corrective action requests from last inspection

Under "Inspection results" all the below information would be filled out during the inspection.

For "Opening meeting"

• the license holder representatives present
• changes to company profile and preventive control plan
• a summary of items discussed

For "Initial walk-through inspection"

• preliminary observations
• scope of inspection
• follow-up questions for establishment employees

For "Inspection"

• name on preventive control plan reviewed
• date on preventive control plane reviewed
• preventive control plan element selected for assessment
• compliance or enforcement actions taken during inspection
  • critical or serious non-compliance

For "Closing meeting"

• license holder representatives present
• summary of items discussed
• summary of license holder’s commitment to address corrective action requests, if any
• note projected date for follow-up inspection

The report ends with space for the inspector to sign and insert the date of the inspection.

Annex D: Compliance and enforcement: range of possible responses

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

a) Inspection

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

b) Refusal to issue export certificate/documents

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

c) Start or stop activities

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

d) Seizure and detention

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

• the food commodity is brought into compliance,
• the court or AMP proceedings are complete, or
• it is ordered returned by the Tribunal or court.

e) Removal or destroy order

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

f) Corrective action request

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

g) Meeting with the licence holder

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

h) Notice of non-compliance

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

i) Publication of non-compliance

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

j) Dispose

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

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

k) Injunction

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

l) Recall

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

m) Actions taken with regard to licences

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

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

n) AMPs

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

o) Recommendation to prosecute

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

Annex E: System performance: preliminary draft indicators

Level 1 System performance

Consistency and quality of delivery

Theme	Considerations for future indicators
1. On-site review
Preparation
Inspector authorization	the inspector has the appropriate designation to conduct the activity the person exercising powers or performing duties or functions has a valid CFIA badge and identification card that is legible, valid, has the correct name, etc.
Inspector training	required training is identified the inspector has successfully completed the required training
Reference and inspection documents and tools	the inspector has the appropriate documents, tools and supplies for the inspection
Determine scope	the regulated party who requires verification is identified appropriately from the work plan or triggers the regulated party file is reviewed and scope is appropriately identified
Conducting the inspection
Opening meeting	an opening meeting is conducted appropriately and scope is adjusted, if required
Initial walk-through inspection	initial on-site assessment of the general conditions is conducted and scope adjusted if required—taking into account any previous corrective action requests
Confirm scope of inspection	scope is adjusted based on observations of the initial walk-through
Completing the inspection	visual verification, record review and staff interviews are used appropriately to collect facts
Product and environmental sampling	samples are collected, identified, handled, stored, packaged, tagged and shipped appropriately
Determining level of compliance	non-compliance is appropriately identified and potential impacts are assessed the appropriate level of compliance is assigned and supported by facts, and recorded appropriately
Communication of the inspection results
Closing meeting	results are communicated in a clear, concise, factual and timely manner and questions are addressed a corrective action request for critical and serious non-compliance is discussed any other regulatory non-compliance is discussed licence holder commitment is obtained or, if not, a proper note is included in the report
Follow-up inspection
	corrective measures have been completed, are effective at addressing the corrective action request and have been documented corrective action requests are closed as per procedures where corrective action requests are not addressed, appropriate action is taken for repeated technical non-compliances, enforcement action is taken
2. Documentation review
Issuing a licence	applications are reviewed for completeness an appropriate licensing decision is made the risk level is correctly assigned the licence or notice of refusal is issued within the service standard
Inspection report	the inspection report provides the regulated party with an accurate summary of the verification and includes any corrective action requests the inspection report conveys the results in a clear, concise, factual, complete and accurate manner a corrective action request is issued for critical and serious non-compliance
Export certificates	the export certificate is complete and accurate the decision to issue a certificate is justified
Laboratory analysis reports	the sample submission form is complete and accurate the sample integrity is maintained the sample is sent to the appropriate laboratory the results of analysis are communicated
Other forms	documents are complete and accurate, such as notice of non-compliance detention documentation
Analysis of compliance and enforcement actions	Are the decisions justified? Is the appropriate Act or regulation cited? Were procedures followed? Was non-compliance rated appropriately? Was corrective action confirmed to be effective and timely? Was the closing of the corrective action request justified?
Delivery of work plan	confirmation that the inspection schedule reflects priorities of the work plan work planning targets are achievable and met inspection priorities are established based on risk and compliance data
Level of oversight	changes in level of oversight are justified
Unplanned inspections	are delivered in accordance with priorities

Level 2: Measuring inspection system design and performance

System design: process management

Theme	Considerations for future indicators
Quality design
Risk levels	inspection and surveillance data, consumer complaints, recalls, etc., are used to establish and adjust risk levels other intelligence, such as identification of emerging risks, is incorporated into the adjustment of the risk level
Licensing	Are food safety events attributable to non-licensed parties? Are conditions of licensing appropriate? Are there trends in licence suspension and/or cancellation?
Preventive control plan	Are elements of the preventive control plan consistent with advances in international or scientific information? trends and causes of foodborne illnesses and recalls identify areas for improvement in expected outcomes, performance criteria or inspection activities
Inspection	increase or decrease in compliance levels trend analysis for critical corrective action requests trend analysis for serious corrective action requests trend in escalation of serious corrective action requests to critical corrective action requests trend analysis for technical non-compliance trend analysis for import alerts analysis of complaints from industry
Export certification	trends of rejection when certified lot-by-lot system trends of rejection when not certified
Exemption requests	impact on regulatory framework
Response to food safety events	recalls of food triggered by illness recalls of food not triggered by illness
Communication with industry
Compliance promotion
Effectiveness of the overall system
Transparency	the information posted is useful
Recognized internationally—demonstrates confidence in Canadian system	risk and science is incorporated into decision making market access is regained following food safety incidents
Effective use of human resources	roles and responsibilities are documented competencies are identified recruitment strategy quality of training
Continuous improvement	integrated feedback loop is created to support continuous improvement

Annex F: Exemptions

The Safe Food for Canadians Act is an act respecting food commodities, including

• their inspection;
• their safety;
• their labelling and advertising;
• their import, export and interprovincial trade;
• the establishment of standards for them;
• the registration or licensing of persons who perform certain activities related to them;
• the establishment of standards governing establishments where those activities are performed; and
• the registration of establishments where those activities are performed.

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

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

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

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

• include exemptions within a single regulatory framework for food, and, in turn,
• administer and enforce the exemptions.

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

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

Annex G: Draft glossary of terms

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

| A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z |

Terminology	Definition
A Applicant (Demandeur)	Any person who applies for a licence, exemption or certificate.
B Biological hazard (Danger biologique)	Any illness- or disease-causing pathogens or micro-organisms that pose a danger to food safety.
C Certification (Certification)	Written assurance from a competent authority that foods or preventive control systems conform to requirements.
Chemical hazard (Danger chimique)	A chemical substance that poses a danger to food safety.
Compliant food (aliment conforme)	Food commodities that meet food safety and other regulatory requirements.
Contaminant (Contaminant)	Any biological, physical, chemical agents or other substances that are present in food and that compromise food safety or suitability.
Contamination (Contamination)	The presence of any contaminant in food or food contact surfaces.
Control measure (Mesure de contrôle)	Any action or activity that can be used to prevent9 or eliminate a food safety hazard or reduce it to an acceptable level. (Hazard Analysis and Critical Control Point System and Guidelines for Its Application, Annex to CAC/RCP 1-1969 (Rev.4 – 2003), FAO/CODEX)
Corrective action (Mesure corrective)	The steps that a regulated party takes to address non-compliance, which can include controlling affected product, conducting root cause analysis and preventing recurrence.
Corrective action request (CAR) (Demande de mesure corrective (DMC))	A document that the CFIA issues to a regulated party in cases of serious or critical non-compliance. The corrective action request describes the non-compliance and requires the licence holder to take corrective actions.
Critical non-compliance (Non-conformité critique)	Repeated serious non-compliance or non-compliance that has an immediate impact on food safety.
Cross-contamination (Contamination croisée)	A situation that occurs when hazards that are carried by utensils, equipment, surfaces or food handlers are transferred from one food, ingredient or surface to another.
D Distributor (Distributeur)	A person, including a wholesaler, who distributes food or other materials.
Distribution centre (Centre de distribution)	A warehouse or other specialized building that is stocked with food or things to be redistributed to retailers, wholesalers or directly to consumers.
E Employee (Employé)	A person who is employed by a food operation or establishment.
Establishment (Établissement)	Any place, including a conveyance, where a food commodity is manufactured, prepared, stored, packaged or labelled . (Safe Food for Canadians Act)
Exporter (Exportateur)	Any person who sells or trades food from Canada to another country.
F Food grade materials (Matériaux de qualité alimentaire)	A designation that means that a material is safe for human consumption, is permitted to come in contact with food contact surfaces or is food intended for human consumption.
H Hazard analysis (Analyse de danger)	The process of collecting and interpreting information on hazards and on conditions that lead to hazards, to decide which activities pose a significant risk to food safety and therefore should be addressed in the preventive control plan.
I Importer (Importateur)	Any person in Canada who imports food commodities into Canada.
Ingredient (Ingrédient)	An individual unit of food that is combined as an individual unit of food with one or more other individual units of food to form an integral unit of food that is sold as a prepackaged product (Food and Drug Regulations)
M Monitoring (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)
N Non-compliance (Non-conformité)	The state that occurs when a regulated party or thing does not conform to statutory or regulatory requirements.
Not ready-to-eat food (Aliment qui n’est pas du prêt-à-manger)	Foods that require a cooking step before consumption by consumers for safety. The cooking step is required to kill pathogenic micro-organisms that may be present in the food.
O Objective evidence (Preuve objective)	Information directly collected by an inspector through observation, measurement, testing or other means.
Oversight (Surveillance)	Inspection activities designed to determine whether a regulated party is complying with Acts and regulations administered or enforced by the CFIA
P Pests (Organismes nuisibles/parasites)	Any animal, plant, fish or insect of public health importance including, but not limited to, birds, rodents, roaches, flies and larvae that may carry pathogens that can contaminate foods.
Physical hazard (Danger physique)	Any foreign materials that are not normally found in food and that pose a danger to food safety.
Premises (Lieux)	The lands, buildings and facilities where food is prepared.
Prepare (Conditionnement)	In respect of a food commodity, includes to process, treat, preserve, handle, test, grade, code or slaughter it or to do any other activity in respect of it that is prescribed.
Preventive control plan (Plan de contrôle préventif)	A combination of control measures10 that, when taken as a whole, provide for a science-based approach to managing risks posed by hazards.
Primary producer (Producteur primaire)	A person who cultivates, grows, produces, raises, picks or harvests agricultural products or fishery products and does not alter the nature of the raw product.
R Ready-to-eat food (aliment prêt-à-manger)	(a) do not require any further preparation before consumption, except perhaps washing/rinsing, thawing or warming for aesthetics or palatability (b) are in a form that is edible without additional preparation to achieve food safety (c) do not require further preparation or cooking before consumption (d) are ordinarily consumed in the same state as that in which they are sold
Regulated party (Partie réglementée)	A person (including an individual, corporation, partnership or organization) carrying on business in Canada who is subject to the Acts and regulations administered by the CFIA.
Representative sample (Échantillon représentatif)	The collection of a selected portion or subset of the thing that is intended to provide information on a given characteristic and that accurately reflects the characteristics of that thing.
Requirements (Exigences)	The criteria set down in acts or regulations administered or enforced by the CFIA.
Risk (Risque)	A function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard(s) in food. (CODEX Procedural Manual, 20th Edition, FAO, 2011)
Risk-based inspection (Inspection fondée sur le risque)	A method for using risk to prioritize and manage inspection efforts.
S Serious non-compliance (Non-conformité grave)	Non-compliance that has a potential impact on food safety.
Surveillance (Surveillance)	The collection, analysis and interpretation of food sampling and inspection information to establish baseline data or identify trends.
Systems-based approach (Approche axée sur un système)	An integrated, flexible, multi-faceted approach to analysing and managing risk that considers the underlying actions of all of the steps or processes and controls that make up food production.
T Third-party verification (Vérification par une tierce partie)	The use of a private, independent service provider, organization or company to verify that a regulated party has adhered to a standard.
V Validation (Validation)	Obtaining evidence that a control measure or combination of control measures, if properly implemented, is capable of controlling the hazard to a specified outcome. (CODEX, Guidelines for validation of food safety control measures, CAC/GL 69-2008)
Verification (Vérification)	The application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine whether the control measure is or has been operating as intended. (CODEX, Guidelines for validation of food safety control measures, CAC/GL 69-2008)
Violation (Infraction)	Any contravention of the acts or regulations administered or enforced by the CFIA or any refusal or neglect to perform any duty imposed by or under the acts or regulations

Additional resources:

Codex Alimentarius Commission

• Hazard Analysis and Critical Control Point System and Guidelines for Its Application, Annex to CAC/RCP 1-1969 (Rev.4 – 2003)
• Principles for Food Import and Export Inspection and Certification , CAC/GL 20-1995
• CODEX Procedural Manual, 20^th Edition, FAO, 2011

Department of Justice, Food and Drug Regulations, C.R.C, c. 870. Available: http://laws-lois.justice.gc.ca/PDF/C.R.C.,_c._870.pdf

Health Canada, Food Directorate, Food-related health risk assessment. Available: http://www.hc-sc.gc.ca/fn-an/securit/chem-chim/food_risk-risq_alim-eng.php

Risk-based Inspection as part of an Overall Inspection Management Program (121kb). Available: http://visionsenterprise.com/pdf/rbimanagementprogram.pdf

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¹Codex Alimentarius is the standard-setting body under the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO).

² The CFIA shares responsibility of oversight of intraprovincially-traded food with the provincial and territorial governments for health and safety.

³ Preventive control plans are based on Codex Alimentarius principles and standards.

⁴Preventive control plans must be made available to the CFIA upon request.

⁵Depending on the circumstances, there may be situations in which immediate suspension of the licence would be justified and appropriate in order to protect human health.

⁶This would apply only to situations in which suspension is not effective immediately.

⁸ If these substances are misused, resulting in contamination of foods, such an action would be considered to be in violation of paragraph 4(a) of the Food and Drugs Act, which states, " No person shall sell an article of food that has in or upon it any poisonous or harmful substance."

⁹ See “Preventive Control Program” definition.

¹⁰ See “Control measure” definition.

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