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

Regulations are current to 2019-07-01 and last amended on 2019-06-17. Previous Versions

PART 4Preventive Controls (continued)

DIVISION 4Maintenance and Operation of Establishment (continued)

SUBDIVISION GHygiene (continued)

Marginal note:Spitting, chewing gum and other acts

 Any person who enters or is in an area where a food is manufactured, prepared, stored, packaged or labelled or where a food animal is slaughtered must refrain from spitting, chewing gum, using tobacco products, eating, having unnecessary contact with the food and doing any other act that presents a risk of contamination of the food.

Marginal note:Objects and substances — risk of contamination

 Any person who enters or is in an area where a food is manufactured, prepared, stored, packaged or labelled or where a food animal is slaughtered must refrain from wearing or using any object or substance that presents a risk of contamination of the food.

Marginal note:Reporting of disease, illness, symptoms and lesions

 Any person who works in an area where a food is manufactured, prepared, stored, packaged or labelled or where a food animal is slaughtered and who has a disease or illness, symptoms of a disease or illness or an open or infected lesion must report them to the operator.

Marginal note:Communicable disease and lesions — risk of contamination

 The operator must prevent any person who is suffering from, or is a known carrier of, a communicable disease or who has an open or infected lesion from entering or being in an area of an establishment where a food is manufactured, prepared, stored, packaged or labelled or where a food animal is slaughtered if the person’s condition presents a risk of contamination of the food.

DIVISION 5Investigation, Notification, Complaints and Recall

Marginal note:Investigation

  •  (1) An operator who suspects on reasonable grounds that a food presents a risk of injury to human health or does not meet the requirements of the Act or these Regulations must immediately investigate the matter.

  • Marginal note:Notification and mitigation of risk

    (2) If the investigation establishes that the food presents a risk of injury to human health, the operator must immediately notify the Minister and immediately take action to mitigate the risk.

Marginal note:Complaints procedure

  •  (1) An operator must prepare, keep and maintain a document that sets out a procedure for receiving, investigating and responding to complaints that are received in relation to a food.

  • Marginal note:Complaints

    (2) If a complaint is received, the operator must implement the procedure and prepare a document that sets out the details of the complaint, the results of the investigation and the actions taken based on those results and keep it for two years after the day on which the actions are completed.

Marginal note:Recall procedure

  •  (1) An operator must prepare, keep and maintain a document that sets out a recall procedure that enables the effective recall of a food, the name of a contact person who is responsible for the procedure and the name of a contact person who is responsible for conducting recalls.

  • Marginal note:Recall simulation

    (2) The operator must, at least once every 12 months,

    • (a) conduct a recall simulation, based on the recall procedure; and

    • (b) prepare a document that sets out the details of how the recall simulation was conducted and the results of the simulation, and keep that document for two years after the day on which the recall simulation is completed.

  • Marginal note:Recall — notice to Minister

    (3) If an operator determines that a food should be recalled because it presents a risk of injury to human health, the operator must immediately notify the Minister.

  • Marginal note:Recall — implementation

    (4) If a food is the subject of a recall because it presents a risk of injury to human health, the operator must

    • (a) immediately implement the recall procedure; and

    • (b) prepare a document that sets out the details of the recall, including any information that substantiates its effectiveness, and keep the document for two years after the day on which the recall is initiated.

Marginal note:Imported food

 The holder of a licence to import must comply with sections 82 to 84 in respect of a food that is imported.

DIVISION 6Preventive Control Plan

Marginal note:Licence holders

  •  (1) A licence holder must prepare, keep and maintain a written preventive control plan that meets the requirements of section 89 for any activity identified in their licence that they conduct in respect of a food or food animal.

  • Marginal note:Exception — food to be exported

    (2) Despite subsection (1), a preventive control plan is not required to be prepared, kept or maintained for any activity that the licence holder conducts in respect of a food, other than fish or a meat product, that is exported, unless a certificate or other document referred to in section 48 of the Act is sought in respect of the food.

  • Marginal note:Exception — sales of $100,000 or less

    (3) Despite subsection (1), if a licence holder’s gross sales that are derived from food are $100,000 or less for the 12 months before the day on which they most recently made an application for the issuance, renewal or amendment of a licence, a preventive control plan must be prepared, kept and maintained only for any activity that they conduct in respect of

    • (a) a food animal, meat product, fish, dairy product, egg, processed egg product or processed fruit or vegetable product that is identified in their licence; and

    • (b) a food in respect of which a certificate or other document referred to in section 48 of the Act is sought.

Marginal note:Growers or harvesters of fresh fruits or vegetables

 Any person who grows or harvests fresh fruits or vegetables must prepare, keep and maintain a written preventive control plan that meets the requirements of section 89 for any activity that they conduct in respect of those fresh fruits or vegetables if they are

  • (a) to be exported and a certificate or other document referred to in section 48 of the Act is sought in respect of the fresh fruits or vegetables; or

  • (b) to be sent or conveyed from one province to another and the person’s gross sales that are derived from food are more than $100,000 for the previous 12 months.

Marginal note:Implementation

 Any person who is required to prepare, keep and maintain a preventive control plan must implement that plan.

Marginal note:Content of preventive control plan

  •  (1) The preventive control plan must include

    • (a) a description of the measures for ensuring that the applicable requirements of sections 201 and 205, subsection 206(1), sections 208, 218, 221, 296, 306, 307, 316, 317, 321, 322, 324 to 326 and 328 are met;

    • (b) a description of the measures for ensuring that the food is packaged and labelled in a manner that does not contravene subsection 6(1) of the Act;

    • (c) in relation to the applicable requirements of these Regulations,

      • (i) a description of the biological, chemical and physical hazards that are identified under subsection 47(1) as presenting a risk of contamination of a food, of the control measures for preventing or eliminating those hazards or reducing them to an acceptable level and of the evidence that the control measures are effective,

      • (ii) a description of the critical control points, of the related control measures and of the evidence that the control measures are effective,

      • (iii) a description of the critical limits for each critical control point,

      • (iv) the procedures for monitoring the critical control points in relation to their critical limits,

      • (v) the corrective action procedures for each critical control point,

      • (vi) the procedures for verifying that the implementation of the preventive control plan results in compliance with the provisions of the Act and these Regulations, and

      • (vii) documents that substantiate that the preventive control plan has been implemented with respect to subparagraphs (i) to (vi); and

    • (d) in relation to the applicable requirements of sections 128 to 136, paragraphs 140(b) and (c) and sections 141 to 144,

      • (i) a description of the measures for preventing or eliminating a risk of avoidable suffering, injury or death to the food animals during their handling, and of the evidence that those measures are effective,

      • (ii) a description of the measures for preventing or eliminating a risk of avoidable suffering or injury to the food animals during their slaughtering, and of the evidence that those measures are effective,

      • (iii) a description of the performance criteria for evaluating the effectiveness of each of those measures,

      • (iv) the procedures for monitoring each of those measures,

      • (v) the corrective action procedures for each of those measures,

      • (vi) the procedures for verifying that the implementation of the preventive control plan results in compliance with the provisions of the Act and these Regulations,

      • (vii) the procedures for auditing, on a regular basis, the outcome of the implementation of the preventive control plan, and

      • (viii) documents that substantiate that the preventive control plan has been implemented with respect to subparagraphs (i) to (vii); and

    • (e) supporting documents that show evidence of the information recorded under paragraphs (a) and (b), subparagraphs (c)(i) to (vi) and (d)(i) to (vii).

  • Marginal note:Retention period of documents

    (2) Each document referred to in subparagraphs (1)(c)(vii) and (d)(viii) must be kept for two years after the day on which it is prepared.

  • Marginal note:Exception — game animals

    (3) The preventive control plan of the holder of a licence to slaughter a game animal is not required to include any information specified in subsection (1) other than the information specified in subparagraphs (1)(c)(i) and (d)(i).

  • Marginal note:Additional content — import

    (4) The preventive control plan of the holder of a licence to import must also include the information specified in subparagraphs (1)(c)(i) to (vii) in relation to the requirements of section 11.

  • Marginal note:Additional content — export

    (5) The preventive control plan of the holder of a licence to export must also include the information specified in subparagraphs (1)(c)(i) to (vii) in relation to the requirements of subsection 15(1).

  • Marginal note:Additional content — post-mortem programs

    (6) The preventive control plan of a licence holder who is authorized under subsection 160(3) to conduct a post-mortem examination program or a post-mortem defect management program must also include the information specified in subparagraphs (1)(c)(i) to (vii) and paragraph (1)(e) in relation to that program and must meet the requirements that are set out in

    • (a) in the case of a port-mortem examination, the document entitled Fundamentals of the Post-mortem Examination Program, prepared by the Agency and published on its website, as amended from time to time; or

    • (b) in the case of a post-mortem defect management program, the document entitled Fundamentals of the Post-mortem Defect Management Program, prepared by the Agency and published on its website, as amended from time to time.

 
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