Safe Food for Canadians Regulations (SOR/2018-108)

PART 4Preventive Controls

DIVISION 1Interpretation and Application

Marginal note:Definitions

45 The following definitions apply in this Part.

acceptable level

acceptable level means a level of a biological, chemical or physical hazard that does not present a risk of contamination of the food. (niveau acceptable)

agronomic input

agronomic input means an input that is used in growing fresh fruits or vegetables, and includes agricultural chemicals, biological controls, pollinators, commercial fertilizers, compost, compost tea, green manure, manure, mulch, row covers, soil amendments and pulp sludge. (intrant agronomique)

control measure

control measure means a measure that can be applied to prevent or eliminate any biological, chemical or physical hazard that presents a risk of contamination of a food or to reduce the hazard to an acceptable level. (mesure de contrôle)

critical control point

critical control point means a step at which the application of a control measure is essential to prevent or eliminate any biological, chemical or physical hazard that presents a risk of contamination of a food or to reduce the hazard to an acceptable level. (point de contrôle critique)

low-acid food

low-acid food means a food of which any component has a pH that is greater than 4.6 and a water activity, as determined by the ratio of the water vapour pressure of the component to the vapour pressure of pure water at the same temperature and pressure, that is greater than 0.85. (aliment peu acide)

operator

operator means

• (a) the holder of a licence to manufacture, process, treat, preserve, grade, store, package or label a food, to store and handle an edible meat product in its imported condition or to slaughter a food animal;

• (b) any person who grows or harvests fresh fruits or vegetables; and

• (c) any person who handles fish in a conveyance. (exploitant)

scheduled process

scheduled process means a process in which a treatment is applied to a food to render the food commercially sterile, taking into account the critical physical and chemical factors that affect the treatment’s effectiveness. (traitement programmé)

Marginal note:Application

• 46 (1) Unless otherwise specified, the requirements of this Part apply in respect of

  • (a) any foods that are to be exported or sent or conveyed from one province to another;

  • (b) any edible meat products that are imported, during their storing and handling in their imported condition, for the purpose of the exercise of an inspector’s powers under the Act; and

  • (c) any food animals from which meat products that are to be exported or sent or conveyed from one province to another may be derived.

• Marginal note:Exception

  (2) Despite subsection (1), in the case of the holder of a licence to import, section 86 applies in respect of any food that is imported.

• Marginal note:Application — establishment

  (3) The requirements of this Part that refer to an establishment apply in respect of

  • (a) in the case of the holder of a licence referred to in paragraph (a) of the definition operator in section 45, an establishment that is identified in their licence;

  • (b) in the case of any person referred to in paragraph (b) of the definition operator in section 45, an establishment where that person grows or harvests fresh fruits or vegetables; and

  • (c) in the case of any person referred to in paragraph (c) of the definition operator in section 45, the conveyance where that person handles fish.

• Marginal note:Establishment — slaughtering game animals

  (4) For the purposes of section 50, subsection 56(2) and sections 66, 67 and 71, in the case of an establishment that is identified in a licence to slaughter a game animal, the facility in the establishment is deemed to be the establishment.

• Marginal note:Exception — game animals

  (5) Section 55, subsection 56(1) and sections 58 and 69 do not apply in respect of an establishment where game animals are slaughtered.

DIVISION 2Biological, Chemical and Physical Hazards

Marginal note:Identification and analysis of hazards

• 47 (1) An operator must identify and analyze the biological, chemical and physical hazards that present a risk of contamination of a food.

• Marginal note:Prevention, elimination and reduction of hazards

  (2) The operator must prevent, eliminate or reduce to an acceptable level the hazards referred to in subsection (1) by using control measures that are shown by evidence to be effective, including any treatment or process and including, in the case of a meat product, the control measures that are set out in the document entitled Preventive Control Requirements for Biological Hazards in Meat Products, prepared by the Agency and published on its website, as amended from time to time.

• Marginal note:Imported food

  (3) The holder of a licence to import must comply with subsections (1) and (2) in respect of a food that is imported.

DIVISION 3Treatments and Processes

Marginal note:Application of scheduled process to low-acid food

• 48 (1) If a low-acid food is in a hermetically sealed package, an operator must apply the scheduled process referred to in subparagraph (3)(a)(i) and, if batch thermal treatment is applied, must use a temperature-sensitive indicator that visually indicates that the package has been thermally treated.

• Marginal note:Exception — refrigerated or frozen food

  (2) Subsection (1) does not apply if the low-acid food is kept refrigerated or frozen and the expressions “Keep Refrigerated” and “garder réfrigéré”, or “Keep Frozen” and “garder congelé”, as the case may be, are shown on the principal display panel.

• Marginal note:Documents

  (3) The operator must prepare documents that set out

  • (a) in respect of each low-acid food,

    • (i) a description of the scheduled process that will be applied to it, together with the name of the person who is responsible for developing the process, and

    • (ii) the formulation of the food; and

  • (b) in respect of each application of the scheduled process to a low-acid food,

    • (i) the name of the food and its production volume,

    • (ii) the equipment that is used for the treatment,

    • (iii) any parameters of the treatment, such as start and end times, temperatures of the treatment and the pressure used in the treatment,

    • (iv) a description of any maintenance of, and of any modifications to, the equipment that is used for the treatment,

    • (v) any deviations from the scheduled process and any corrective action taken,

    • (vi) the incubation results, and

    • (vii) a description of any treatment of the cooling water.

• Marginal note:Retention period of documents

  (4) The documents that set out the information referred to in paragraph (3)(a) must be kept for three years after the day of the most recent application of the scheduled process to the low-acid food, and the documents that set out the information referred to in paragraph (3)(b) must be kept for three years after the day of the application of the scheduled process.

DIVISION 4Maintenance and Operation of Establishment

SUBDIVISION AResponsibility of Operator

Marginal note:Maintenance and operation

49 An operator must maintain and operate an establishment so that the requirements of sections 50 to 81 are met.

SUBDIVISION BSanitation, Pest Control and Non-food Agents

Marginal note:Clean and sanitary condition

• 50 (1) An establishment, and any conveyance or equipment in it that is used in connection with an activity that is regulated under the Act, must be clean and in a sanitary condition.

• Marginal note:Cleaning and sanitation

  (2) The cleaning and sanitation of the establishment and of any conveyance or equipment in it that is used in connection with an activity that is regulated under the Act must be conducted in a manner that does not present a risk of contamination of a food.

Marginal note:Animals — establishment

• 51 (1) An establishment must be protected against the entry of any animal that presents a risk of contamination of a food, except if, in the case of any land that forms part of an establishment, there are no reasonably practicable measures that may be taken to prevent the entry of such animals onto the land.

• Marginal note:Animals — facility or conveyance

  (2) An animal must not be in a facility or conveyance where a food is manufactured, prepared, stored, packaged or labelled or where a food animal is slaughtered, unless the animal is

  • (a) a food that is intended to be manufactured, prepared, stored, packaged or labelled in the facility or conveyance;

  • (b) a food animal that is intended to be slaughtered in the facility or conveyance, whether or not the meat products that may be derived from it are intended to be exported or to be sent or conveyed from one province to another; or

  • (c) an animal that is intended to be used in the manufacturing or preparing of a food in the facility or conveyance.

• Marginal note:Risk of contamination

  (3) Any measures that are taken for the purposes of complying with subsections (1) and (2) must not present a risk of contamination of a food.

Marginal note:Sanitizers, agronomic inputs and non-food chemical agents

52 Any sanitizer, agronomic input or non-food chemical agent that is in an establishment must

• (a) be properly and clearly identified;

• (b) be suitable for its intended use and not present a risk of contamination of a food; and

• (c) be handled and used in a manner that does not present a risk of contamination of a food and that is in accordance with any manufacturer’s instructions.

SUBDIVISION CConveyances and Equipment

Marginal note:Conveyances and equipment — food

53 Any conveyance or equipment that is used in the manufacturing, preparing, storing, packaging or labelling of a food or in the slaughtering of a food animal must

• (a) be appropriate for the food or the food animal, as the case may be, and for the activity being conducted;

• (b) be designed, constructed and maintained to prevent contamination of the food;

• (c) be constructed of, and maintained using, materials that are suitable for their intended use and, if those materials present a risk of contamination of the food, that are

  • (i) corrosion-resistant,

  • (ii) durable,

  • (iii) capable of withstanding repeated cleaning and, if necessary to prevent contamination of the food, repeated sanitizing, unless the equipment is intended for a single use, and

  • (iv) free of any noxious constituent;

• (d) be equipped with instruments to control, indicate and record any parameters that are necessary to prevent contamination of the food;

• (e) function as intended;

• (f) be accessible and, if necessary for its cleaning, sanitizing, maintenance or inspection, able to be easily disassembled;

• (g) be used, maintained and, if necessary, calibrated in accordance with the manufacturer’s instructions and in a manner that does not present a risk of contamination of the food; and

• (h) have surfaces that, if they come into contact with a food, are smooth, free from pitting, cracks and flakes and non-absorbent, except when the surface does not present a risk of contamination of the food.

Marginal note:Other conveyances and equipment

54 Any conveyance or equipment in an establishment that is used to handle any contaminated materials, any waste or any other thing that is inedible must, unless that conveyance or equipment does not come into contact with those materials, waste or things,

• (a) be used only for that purpose;

• (b) be identified as being reserved for that purpose; and

• (c) meet the applicable requirements of section 53.

Marginal note:Equipment — restraining

55 An establishment where food animals are slaughtered must have equipment for restraining food animals during their handling, their assessment, their ante-mortem examination and their inspection.

SUBDIVISION DConditions Respecting Establishments

Marginal note:Land

• 56 (1) If any land that forms part of an establishment presents a risk of contamination of a food, measures must be taken to eliminate the risk.

• Marginal note:Location

  (2) If an establishment is located near any place or thing that presents a risk of contamination of a food, measures must be taken to eliminate the risk.

Marginal note:Interior of facility or conveyance

57 The interior of any facility or conveyance where a food is manufactured, prepared, stored, packaged or labelled or where a food animal is slaughtered must be

• (a) designed to prevent the accumulation of substances that present a risk of contamination of the food, including dust, dirt, micro-organisms and food particles, and to permit effective maintenance, cleaning and sanitizing;

• (b) designed, constructed and maintained in such a manner that

  • (i) the size and layout is adequate to accommodate the activity being conducted and the equipment used in the activity,

  • (ii) the entry of insects, rodents and other vermin is prevented,

  • (iii) any floors, walls, ceilings, windows and doors are smooth, non-absorbent and impervious to moisture, except if those floors, walls, ceilings, windows or doors do not present a risk of the contamination of the food, and

  • (iv) any floors provide or permit good drainage, except if there is no risk of liquid accumulation;

• (c) constructed of, and maintained using, materials that are

  • (i) suitable for their intended use,

  • (ii) appropriate for the food or the food animal, as the case may be, and for the activity being conducted,

  • (iii) durable,

  • (iv) capable of withstanding repeated cleaning and, if necessary to prevent contamination of the food, repeated sanitizing, and

  • (v) free of any noxious constituent; and

• (d) of sound construction and in good repair.

Marginal note:Slaughtering — separate areas

• 58 (1) An establishment where food animals are slaughtered must have separate areas for

  • (a) keeping, examining and inspecting food animals;

  • (b) segregating and isolating food animals under section 132 or paragraph 140(b);

  • (c) holding food animals that show a deviation from normal behaviour, physiology or appearance; and

  • (d) humanely killing food animals under paragraph 140(c).

• Marginal note:Inedible meat products area

  (2) The establishment must also have an enclosed area for the handling of inedible meat products.

• Marginal note:Movement of food animals

  (3) Floors, ramps, gangways and chutes that are used by food animals in the establishment must provide secure footing and must not present a risk of injury to the food animals during movement.

• Marginal note:Stations for inspections, examinations and screenings

  (4) The establishment must be equipped with inspection stations at the fixed locations specified by the President under subsection 41(2) and in the numbers determined by the President under subsection 41(1), and

  • (a) if a licence holder is authorized to conduct a post-mortem examination program, stations for post-mortem examinations; or

  • (b) if a licence holder is authorized to conduct a post-mortem defect management program, stations for post-mortem screenings.