A New Regulatory Framework for Federal Food Inspection: Discussion Document
Annex 2: Proposed Regulatory Requirements (Outcome-Based) for Primary Production of Fresh Produce

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Fresh Produce includes fresh fruit and vegetables, edible fungi, nuts, fresh herbs, sprouts and edible flowers that grown in the field (with or without cover) or in protected facilities (e.g., hydroponic systems, greenhouses, mushrooms, sprouts).

1 – Processes and Products Requirements

1.1 Primary Production Control

1.1.1 Agricultural Inputs and Packaging Material

  • Agricultural inputs and packaging material used in the primary production of fresh produce shall be managed to prevent contamination of fresh produce and labelling inaccuracies.

1.1.2 Primary Production Design and Control

  • Primary production shall be designed to result in the production of safe produce that is accurately labelled and meets all regulatory requirements, including grade standards. This shall be demonstrated/validated using scientific methods.
  • The steps involved in primary production shall be documented with a written description which shall include:
    • a description of all the steps and agricultural inputs involved;
    • associated control measures and critical limits; and
    • be specific for each equipment and commodity produced.
  • All critical factors identified in the written documentation shall be managed to meet safety and labelling requirements.
  • The written documentation shall be updated whenever changes are made to the system. Growing
  • Fresh produce shall be grown in a manner to prevent contamination.
  • Agricultural inputs shall be managed to prevent contamination of the fresh produce and the growing environment. Harvesting
  • Harvest shall be timed to prevent contamination of fresh produce.
  • Fresh produce shall be harvested in a manner to prevent contamination. Packing, including field-packing
  • Only food additives and chemicals permitted for use in the fresh produce as prescribed in the FDR shall be used.
  • Fresh produce shall meet the grades and standards as prescribed in these regulations.
  • Fresh produce shall be packaged and labelled in a manner to prevent contamination and labelling inaccuracies.

1.2 Product Control Requirements

1.2.1 Packaging Control

  • Handling and use of packaging materials 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

  • Packaging material shall be marked with a code mark.
  • 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 packaging material.
  • Cases/shipping containers shall be coded in a manner that represents the code mark on the packaging material within.
  • Labels shall match the fresh produce.

1.2.3 Finished Product Evaluation

  • Finished products shall be evaluated to confirm compliance with prescribed safety 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 Detergent, Sanitizer and Chemical

  • Shall be managed by personnel with competencies appropriate to the activity and in accordance with manufacturers' instructions.
  • Shall be stored in identified containers and locations.

2.3 Pest Control Program

  • Entry of pests into indoor production facilities shall be prevented and there shall be a system in place to detect and eliminate pests.
  • No animals are allowed in indoor production facilities.
  • Assistance animals are only permitted in non-production areas.

3 – Hygiene and Competencies Requirements

3.1 Clothing and Footwear

  • Every person who enters in the production and preparation site of fresh produce 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 fresh produce or surfaces likely to come into contact with fresh produce.

3.2 Hygienic Practices and Behaviour

  • Every person who enters production and preparation sites of fresh produce shall:
    • maintain personal cleanliness and take measures to prevent contamination of fresh produce;
    • refrain from behaviours which could result in contamination of fresh produce;
    • wash their hands at any time when personal cleanliness may affect the safety of fresh produce;
    • avoid unnecessary contact with fresh produce;
    • sanitize their hands where direct contact with fresh produce 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 the fresh produce, or a surface with which the fresh produce comes into contact.
  • Any person in a primary production or packing site 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 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 primary production and packing.

3.4 Competency

  • Persons undertaking or supervising the primary production of fresh produce, maintenance and calibration of equipment or responsible for the preventive control plan, shall have competencies in food safety, hygiene and production practices.

4 – Equipment Design and Maintenance Requirements

4.1 General Equipment (including instrumentation and portable 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 fresh produce or its packaging materials.
  • Equipment, instruments and utensils shall be made of materials that do not contaminate or damage the fresh produce or its packaging materials, when used as intended, and are capable of withstanding repeated cleaning, 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 fresh produce.
  • Equipment shall be fitted, where necessary, with the appropriate control device(s).

4.2 Maintenance and Calibration

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

5 – Environment, Physical Structure and Maintenance Requirements

5.1 Environment

  • Production areas shall take place on land:
    • that is not contaminated or in such proximity to any source of pollution that is likely to contaminate food commodities.
    • where domestic and wild animals are excluded to the extent possible.

5.2 Building Exterior – Outside Property and Building [indoor production]

  • 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 fresh produce or its packaging material.

5.3 Building Interior [indoor production]

  • 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 fresh produce or its packaging material.

5.3.1 Floors, Walls, Ceilings

  • Floors, walls, and ceilings shall be constructed of material that is durable, cleanable, and suitable for the production conditions in the area.
  • Floors shall have drainage that prevents standing or pooled water.

5.3.2 Windows and Doors

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

5.3.3 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 regulated flow in the process from the arrival of the raw material at the establishment to the finished product.

5.3.4 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.

5.3.5 Air quality and ventilation

  • Natural or mechanical ventilation shall provide sufficient air exchange to prevent unacceptable accumulations of 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.

5.3.6 Sanitary Facilities [indoor and outdoor production] 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 hand-washing 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.

5.3.7 Other Facilities 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
  • If grading or inspection is required by CFIA staff the establishment shall provide suitable facilities.

5.4 Water and Ice

  • The safety and quality of water and ice shall be controlled to prevent contamination.
  • Water and ice shall be potable or clean and shall be suitable for the process being undertaken.
  • Water and ice shall be sampled, tested and analyzed to confirm their safety for the intended purpose.
  • Hot and cold potable water and ice supply shall be protected against contamination and supply shall be adequate to meet operational requirements.
  • There shall be no cross-connections between clean, potable, and non-potable water supplies and means must be provided to prevent back-flow or back-siphonage.
  • Water delivery systems are maintained, cleaned and stored in a manner to prevent contamination.
  • Water and ice storage facilities shall be adequately designed, constructed and maintained to prevent contamination.
  • Water, 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.
  • 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.

5.5 Waste Management and Disposal

  • Sewage, effluent and waste storage, treatment and disposal systems:
    • Receptacles for the storage of waste and inedible material, prior to removal from the production site or establishment, shall meet operational needs and shall be identified.
    • Waste shall not be allowed to accumulate in production, handling, storage sites and other working areas and the adjoining environment except so far as is unavoidable for the proper functioning of the business.
    • Primary production 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

  • Fresh produce and packaging materials shall be transported, received and stored under conditions that prevent damage, spoilage and contamination.
  • Carriers used to transport fresh produce or packaging materials shall be designed constructed, maintained, cleaned and utilized in a manner to prevent food contamination.
  • Fresh produce 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.
  • Fresh produce that is returned or recalled is allowed back into the primary production site or its surrounding environment if it is clearly identified and isolated in a designated area for disposition.
  • A stock rotation system shall be used to prevent deterioration and spoilage of fresh produce and damage to/contamination of packaging material.

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 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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