A New Regulatory Framework for Federal Food Inspection: Discussion Document
Annex 1: Proposed Regulatory Requirements (Outcome-Based)

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1 – Processes and Products Requirements

1.1 Process Control

1.1.1 Incoming ingredients/materials, live animal for slaughter and packaging materials

  • Incoming ingredients, live animal for slaughter, raw materials and packaging materials, including rework materials used to make a food commodity shall be managed to prevent contamination of the food commodity and labelling inaccuracies.

1.1.2 Product formulations and specifications

  • For each food commodity being manufactured, there shall be a written formula as well as specifications for each finished food commodity.
  • All factors in the product formulation that may be critical to the product's composition, nutritional profile, labelling and safety shall be identified and managed.
  • Only food additives, nutrients, and chemicals permitted for use in the food commodity as prescribed in these regulations and the FDR shall be used.
  • Foods for which grades and standards are prescribed in these regulations shall contain only the ingredients prescribed in these regulations and the FDR.
  • Food commodities shall be formulated and labelled to comply with applicable Canadian legislation.
  • Conditions under which rework may be safely used shall be identified.

1.1.3 Process Design and Control

  • Each process is designed to produce safe food that is accurately labelled and meets all regulatory requirements including composition. This shall be demonstrated/validated using scientific methods
  • Each process is documented with a written description which shall include a description of the processing steps, associated control measures and critical limits and be specific for each equipment, food commodity, container size and type.
  • All critical processing factors identified in the written documentation shall be managed to meet the safety, compositional integrity and labelling requirements
  • The written documentation shall be updated whenever changes are made to the system

1.2 Product Control

1.2.1 Packaging Control

  • Handling and use of packaging materials during processing is managed.
  • Packaging materials suitable for the intended purpose shall be used.
  • Contaminated, damaged or defective packaging materials shall not be used

1.2.2 Product Coding and Labelling Control

  • Each food commodity shall be marked with a code mark on the label or container
  • The code mark shall be applied in a legible and permanent manner.
  • The exact meaning of the code shall be available to the inspector
  • Application of codes shall not compromise the integrity of the container
  • Cases/shipping containers shall be coded in a manner that represents the container codes within
  • Labels shall match the food commodity

1.2.3 Finished Product Evaluation

  • Finished products shall be evaluated to confirm compliance with prescribed safety, compositional and labelling requirements.

2 – Sanitation and Pest Control Requirements

2.1 Sanitation Program

  • Equipment including food contact and non-food contact surfaces, utensils and premises, shall be maintained in a clean and sanitary condition

2.2 Detergents, Sanitizers and Chemicals

  • Managed by personnel with competencies appropriate to the activity and in accordance with manufacturers' instructions.
  • Stored in identified containers and locations.

2.3 Pest Control Program

  • Entry of pests into the facility shall be prevented and there shall be a system in place to detect and eliminate pests
  • No animals, other than those intended for slaughter for food, shall be allowed entry into an establishment.
  • Assistance animals shall be permitted only in non-processing areas.

3 – Hygiene and Competencies Requirements

3.1 Clothing and Footwear

  • Every person who enters or is in any area of an establishment where a food commodity is prepared shall:
    • wear protective clothing, footwear and coverings fit for purpose;
    • take measures to prevent their body, anything from their body, and anything they are wearing from contaminating food or surfaces likely to come into contact with food.

3.2 Hygienic Practices and Behaviour

  • Every person engaged in the preparation of a food product shall:
    • maintain personal cleanliness and take measures to prevent contamination of food;
    • refrain from behaviours which could result in contamination of food;
    • wash their hands at any time when personal cleanliness may affect food safety;
    • avoid unnecessary contact with ready-to-eat food;
    • sanitize their hands where direct food contact is unavoidable.

3.3 Health

  • No person who is suffering from or is a known carrier of a communicable disease which is transmissible through food or who has an open or infected lesion shall work in any area of a food establishment where there is a danger of contaminating a food product, or a surface with which a food product comes into contact.
  • Any person in a food establishment who has or appears to have symptoms of a disease or illness that could be transmitted through a food product shall report the symptoms, disease or illness to the licence holder.
  • Upon being notified of a disease or illness the licence holder shall determine whether the person must undergo a medical examination or be excluded from certain areas of the food establishment.

3.4 Competency

  • Persons undertaking or supervising food handling operations, maintenance and calibration or responsible for PCPs shall have competencies in food safety, manufacturing and food hygiene matters

4 – Equipment Design and Maintenance Requirements

4.1 General Equipment

  • Equipment, including food and non-food contact surfaces, instruments and utensils, including single service, shall be designed, constructed, installed and validated to function consistently as intended, to permit effective cleaning, maintenance and sanitation and to prevent contamination of food or food packaging materials.
  • Equipment, instruments and utensils shall be made of materials that do not contaminate or damage the food or food packaging materials, when used as intended, and are capable of withstanding repeated cleaning, and, as applicable, sanitizing and disinfection.
  • Equipment, instruments and utensils including containers used to handle inedible or contaminated materials shall be identified and shall not be used to handle food products.
  • Equipment shall be fitted, where necessary, with the appropriate control device(s).

4.2 Maintenance and Calibration of Equipment

  • Equipment and instruments shall be maintained and calibrated to perform consistently as intended.

5 – Physical Structure and Maintenance Requirements

5.1 Building Exterior Requirements – Outside Property and Building

  • Buildings and areas surrounding the establishment shall:
    • not be in such proximity to any source of pollution or any place that harbours insects, rodents or other vermin or any similar thing that is likely to contaminate food commodities.
    • be situated on land that:
      • is free of debris and refuse,
      • permits good drainage, and prevents standing or pooled water, and
      • has surfaces that are hard, smooth and impervious to moisture.
  • be designed, constructed and maintained in a manner to prevent conditions which may result in the contamination of a food commodity or packaging material.

5.2 Building Interior Requirements: Design, Construction and Maintenance

  • Building interior, including storages and interior structures, shall be designed, constructed and maintained in a manner to prevent conditions which may result in the contamination of a food commodity or packaging material.

5.2.1 Floors, Walls, Ceilings

  • Floors, walls, and ceilings shall be constructed of material that is suitable for the production conditions and are durable, impervious to moisture, smooth, cleanable.
  • Floors shall be designed to prevent standing or pooled water.

5.2.2 Windows and Doors

  • Windows and doors shall be designed and constructed to:
    • prevent contamination of food,
    • limit direct access to processing areas, and
    • prevent the entry of pests.

5.2.3 Process Flow Separation

  • Separation of activities or incompatible operations shall be provided by physical or other effective means where cross contamination may result.
  • Establishments shall be designed and constructed to provide space for equipment to facilitate maintenance and hygienic operations by means of a controlled flow in the process from the arrival of the raw material at the establishment to the finished product.

5.2.4 Lighting

  • Natural or artificial lighting, of an intensity suitable to the operation shall be provided.
  • Lighting shall not be such that the resulting colour is misleading.
  • Lighting fixtures shall be protected to ensure that food is not contaminated in the event of breakage.

5.2.5 Air Quality and Ventilation

  • Natural or mechanical ventilation shall provide sufficient air exchange to prevent unacceptable accumulations of steam, condensation or dust and to remove contaminated air.
  • Ventilation systems shall be designed and constructed so that air does not flow from contaminated areas to clean areas.
  • If air is used in direct contact with food or packaging materials it shall be hygienically sourced and treated.

5.2.6 Sanitary Facilities Employee facilities
  • Employee facilities including hand washing stations, lavatories, lunch and change rooms shall be designed, constructed, maintained and suitably located to permit effective employee hygiene and to prevent contamination.
  • Facilities for handwashing shall be provided with hot and cold running water, materials for cleaning hands and means for hygienic drying. Cleaning and Sanitizing Facilities
  • Cleaning and sanitizing facilities shall be designed, constructed, maintained and located to prevent contamination.

5.2.7 Other Facilities Facilities for animal holding and slaughter
  • Receiving and holding facilities for animal for slaughter shall allow the segregation of animals as necessary to achieve safe and humane conditions.
  • Slaughter establishment shall be equipped with facilities for:
    • restraining animals for slaughter for detailed inspection,
    • conveying injured or disabled animals for slaughter in a humane manner, and
    • slaughtering animals that have been identified as condemned. Facilities for receiving and storing returned or recalled products
  • Facilities for receiving and storing returned or recalled products shall permit segregation, appropriate storage conditions and areas for re-inspection. Facilities for CFIA staff
  • Where CFIA staff have a continuous presence in an establishment there shall be access to showers, dressing rooms, lavatories and lockers and an office suitably equipped for use by CFIA inspection staff.
  • If grading or inspection is required by CFIA staff the establishment shall provide suitable facilities.

5.3 Water/Ice/Steam

  • The quality and safety of water, ice and steam in direct contact with food or food contact surfaces is controlled to prevent contamination.
  • Water shall be potable or clean and shall be suitable for the process being undertaken.
  • Water, ice and steam shall be sampled, tested and analyzed to confirm their safety for the intended purpose.
  • Hot and cold potable water, ice and steam supply shall be protected against contamination and supply shall be adequate to meet operational requirements.
  • There shall be no cross-connections between potable and non-potable water supplies and means must be provided prevent back-flow or back-siphonage.
  • Water and ice storage facilities shall be adequately designed constructed and maintained to prevent contamination.
  • Water and steam including re-circulated water, when treated, shall be treated, monitored and maintained as appropriate for the intended purpose. Treatment chemicals, where used, shall be safe and used at concentrations as per the manufacturer's recommendations.
  • Ice used as an ingredient or in direct contact with food shall be made from potable water.
  • Water other than potable or clean water may be used for fire protection, boilers or auxiliary services where there is no connection between the system for that water and the system for potable/clean water.

5.4 Waste Management Treatment and Disposal Requirements

  • Sewage, effluent and waste storage, treatment and disposal systems:
    • Receptacles for the storage of waste and inedible material, prior to removal from the establishment, shall meet operational needs and shall be identified.
    • Waste shall not be allowed to accumulate in food handling, food storage, and other working areas and the adjoining environment except so far as is unavoidable for the proper functioning of the business.
    • Food processing waste and inedible materials shall be segregated and labelled "inedible-not for human consumption" so as not to be mistaken for food destined for human consumption.

6 – Receiving, Transportation and Storage Requirements

  • Food commodities and packaging materials shall be transported, received and stored under conditions that prevent damage, spoilage and contamination.
  • Carriers used to transport food commodities or packaging materials shall be designed, constructed, maintained, cleaned and utilized in a manner to prevent food contamination.
  • Food commodities requiring temperature and humidity controls shall be received, stored and transported in a manner to prevent abuse that could result in deterioration affecting food safety and quality.
  • A licence holder shall not permit a food commodity, food packaging material or any other substance into their establishment unless:
    • it is received into an area separate from the processing area.
    • it meets the requirements of these regulations and the Food and Drug Regulations.
    • in the case of a returned or recalled food commodity, it is clearly identified and isolated in a designated area for disposition.
  • Food intended to be used as rework shall be clearly identified and stored in a designated area.
  • A stock rotation system shall be implemented to prevent deterioration and spoilage food commodities and packaging materials.

7 – Recalls, Complaints, and Record-Keeping Requirements

7.1 Recall

Every licence holder shall

  • develop, implement and maintain written procedures for the recall of food products.
  • develop and maintain any product distribution records that are necessary to facilitate the location of products in the event of a product recall.
  • review the product recall procedures and shall conduct a product recall simulation at least once a year.
  • make available to the inspector, in a readily accessible format and location, a copy of the product recall procedures, the results of the product recall simulations for the previous year and the product distribution records for at least one year after the expiry date on the label or container or if there is no expiry date, for at least two years after the date of sale.

7.2 Complaints

Every licence holder shall prepare written procedures and maintain records for receiving, investigating and responding to to food safety and product misrepresentation complaints.

7.3 Record-Keeping

All records associated with the preventive control plan shall:

  • be legible, permanent and accurately reflect the actual event, condition or activity.
  • have errors or changes identified in a manner such that the original record is clear.
  • have each entry made by the responsible person at the time that the specific event occurred.
  • once completed, be signed and dated by the responsible person and be reviewed at an appropriate frequency to provide an early indication of potentially serious deficiencies.
  • in the case of critical records, be signed by a qualified designated individual prior to distribution of product, (e.g., records related to the adequacy of the thermal process and the achievement of a hermetic seal).
  • be retained for at least one year after the expiry date on the label or container or if there is no expiry date, for at least two years after the date of sale.
  • be available upon request.
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