Quick facts
- Part 4 of the Safe Food for Canadians Regulations (SOR/2018-108) runs from section 45 to section 89. It is divided into six divisions, from interpretation through to the preventive control plan itself.
- A licence holder must prepare, keep and maintain a written preventive control plan (PCP) that meets section 89 for every activity identified in their licence (section 86).
- Section 89 sets out the content: measures for the specified requirements, measures for packaging and labelling, the hazard analysis, the critical control points, the critical limits, monitoring procedures, corrective action procedures, verification procedures and the documents that substantiate all of it.
- Records that evidence the food-safety part of the plan must be kept for two years after the day they are prepared. Records tied to a scheduled process for low-acid food follow a longer, three-year clock.
- The operator, not the consultant, carries the duty: section 49 requires the establishment to be maintained and operated so that sections 50 to 81 are met.
- Certain businesses are outside the written-PCP requirement — the CFIA guidance notes annual gross food sales of $100,000 or less as an example.
Part 4 of the Safe Food for Canadians Regulations is where food safety stops being a principle and becomes a set of numbered duties: clean and sanitary condition, equipment that can be cleaned and calibrated, temperature and humidity that are recorded, protective coverings that include gloves, and a recall procedure with named contact people. This article walks the division and section structure of Part 4, from section 45 to section 89, and then maps each duty to the consumable category and record it usually produces on a plant floor.
The map of Part 4: six divisions, forty-five sections
Part 4 is easier to work with once its structure is visible. It is not a list of good ideas; it is a sequence of obligations that runs from definitions to the document that proves you manage them.
| Division | Sections | What it establishes |
|---|---|---|
| Division 1 — Interpretation and Application | 45–46 | Definitions used in the Part (acceptable level, control measure, critical control point, low-acid food, operator, scheduled process, agronomic input) and the application rules, including foods for interprovincial trade and export |
| Division 2 — Biological, Chemical and Physical Hazards | 47 | The hazard identification and analysis duty that everything downstream depends on |
| Division 3 — Treatments and Processes | 48 | Scheduled process requirements, including a temperature-sensitive indicator for batch thermal treatment of hermetically sealed low-acid food |
| Division 4 — Maintenance and Operation of Establishment | 49–81 | The operating core, in seven subdivisions: responsibility of the operator; sanitation, pest control and non-food agents; conveyances and equipment; conditions respecting establishments; unloading, loading and storing; competency; hygiene |
| Division 5 — Investigation, Notification, Complaints and Recall | 82–85 | Investigation, complaints procedure, recall procedure and imported food |
| Division 6 — Preventive Control Plan | 86–89 | Who must have a written plan, implementation, and the content and retention rules |
Two structural points are worth carrying into a facility audit. First, the obligations in Division 4 are not optional elaborations of a plan — section 49 makes the operator responsible for maintaining and operating the establishment so that sections 50 to 81 are satisfied. Second, Division 6 does not replace Divisions 2 to 5; section 89 requires the plan to describe the measures that ensure the earlier requirements are met. In practice the plan is the evidence layer above the operating layer.
What does each Part 4 clause require on the floor?
What follows is the working list — the sections that generate daily tasks, records and purchasing decisions on the floor.
| Section | The duty | What it looks like in practice |
|---|---|---|
| 47 | Identify and analyze the biological, chemical and physical hazards that present a risk of contamination of a food | The hazard analysis that the rest of the plan is built on, including the control measures and the evidence they work |
| 50 | The establishment, and any conveyance or equipment in it used in a regulated activity, must be clean and in a sanitary condition | Sanitation procedures that end in a verified sanitary state, not a visual impression |
| 52 | Any sanitizer, agronomic input or non-food chemical agent in the establishment must be properly and clearly identified, suitable for its intended use, not present a contamination risk, and handled and used in accordance with the manufacturer's instructions | Labelled chemical storage, correct dilution and contact time, and concentration checks |
| 53 | Conveyances and equipment must be appropriate, designed and maintained to prevent contamination, made of cleanable and durable materials, equipped with instruments to control, indicate and record parameters, and used, maintained and calibrated per the manufacturer's instructions | Calibration records for instruments; equipment specified so it survives repeated cleaning and sanitizing |
| 57 | The interior of the facility must be designed to prevent accumulation of contamination risks and to permit effective maintenance, cleaning and sanitizing; floors, walls, ceilings, windows and doors smooth, non-absorbent and impervious to moisture where they present a risk | A cleanable room, not just a cleaned room |
| 59 | Movement of persons and things within, into and out of the facility must be controlled | One-way flows, designated routes and controlled entry points |
| 60 | Physical or other effective means must separate incompatible activities | Separation of raw and ready-to-eat work, and of waste from product |
| 63 | Lighting must be appropriate for the food and the activity | Lighting levels that make inspection and cleaning possible |
| 64 | Ventilation must provide sufficient air exchange to supply clean air and remove unclean air and odours, be accessible and able to be disassembled for cleaning, withstand repeated cleaning, and function as intended | Ventilation that is maintained and verifiable — and cleanable, which matters for filters and housings |
| 65 | Temperature and humidity must be appropriate and maintained; where a heating, cooling or humidity-control system is installed, it must be equipped with instruments to control, indicate and record temperature and humidity levels if necessary to prevent contamination | Logged temperature and humidity, not a setpoint on a panel |
| 66 | Means for removal and disposal of contaminated materials and waste, plus drainage, sewage and plumbing systems that function as intended | Waste routes, containers and disposal records |
| 67 | Hand cleaning and sanitizing stations, lavatories, showers, drinking water stations, break rooms or change rooms that are appropriately equipped, adequate in number and size, readily accessible, and able to withstand repeated cleaning and sanitizing | Accessible hand-wash stations with supplies that are actually stocked |
| 70–71 | Water that might contact food must be potable and protected; the establishment must be supplied with water of adequate quantity, temperature, pH and pressure, plus adequate steam and ice | Water quality evidence and utility capacity that matches production |
| 74 | Storage of food must meet the applicable requirements of the Part | Segregated storage with conditions under control |
| 75 | Anyone involved in regulated activities must have the competencies and qualifications necessary to carry out their duties | Training and competency records, including sanitation and monitoring tasks |
| 76 | Anyone in a food area must wear clothing, footwear and protective coverings — including gloves, a hairnet, a beard net and a smock — in good, clean and sanitary condition and appropriate for the food and the activity | Specified PPE for the area, changed often enough to stay sanitary across a shift |
| 77 | Personal cleanliness, including cleaning and if necessary sanitizing hands immediately on entering the area, immediately after using a lavatory, immediately before starting the activity, and at a frequency appropriate for the food and activity | Hand hygiene at four defined moments, with supplies at the point of use |
| 79 | No person in a food area may wear or use any object or substance that presents a risk of contamination | Jewellery, personal items and loose objects controlled |
| 80 | Anyone with a disease, illness, symptoms, or an open or infected lesion must report it to the operator | Illness reporting that actually reaches the operator, with coverings or exclusion decisions recorded |
| 82 | An operator who suspects on reasonable grounds that a food presents a risk of injury to health, or does not meet the requirements, must immediately investigate | Investigation records, with outcomes and actions |
| 83 | A document setting out a procedure for receiving, investigating and responding to complaints | A complaints log, not a policy statement |
| 84 | A document setting out a recall procedure that enables effective recall, plus the name of a contact person responsible for the procedure and the name of a contact person responsible for conducting recalls | Named people, current contact details and a simulation record |
Read as a list, the pattern is clear: Part 4 repeatedly asks for a documented, verifiable state — clean and sanitary, calibrated, recorded, appropriate, accessible. That is what makes the difference between a plant that passes a CFIA preventive control check and one that has procedures but no evidence.
What section 89 requires the plan itself to contain
Division 6 is where the operating duties become a submission-ready document. Section 86 requires a licence holder to prepare, keep and maintain a written PCP meeting section 89 for each licensed activity. Section 88 adds the step that is easy to overlook: the person required to prepare the plan must implement it.
Section 89 then itemises the content.
| Provision | Required content |
|---|---|
| 89(1)(a) | A description of the measures for ensuring the applicable requirements of the trade, licensing and related provisions listed in the section are met |
| 89(1)(b) | A description of the measures for ensuring the food is packaged and labelled without contravening subsection 6(1) of the Act |
| 89(1)(c)(i) | The biological, chemical and physical hazards identified under subsection 47(1), the control measures, and the evidence the measures are effective |
| 89(1)(c)(ii) | The critical control points, the related control measures and the evidence those measures are effective |
| 89(1)(c)(iii) | The critical limits for each critical control point |
| 89(1)(c)(iv) | The procedures for monitoring the critical control points against their critical limits |
| 89(1)(c)(v) | The corrective action procedures for each critical control point |
| 89(1)(c)(vi) | The procedures for verifying that implementation results in compliance with the Act and the Regulations |
| 89(1)(c)(vii) | The documents that substantiate the plan has been implemented with respect to (i) to (vi) |
| 89(1)(d) | For food animals: measures against avoidable suffering, injury or death during handling and slaughtering, performance criteria, monitoring, corrective actions, verification, regular auditing and substantiating documents |
| 89(1)(e) | Supporting documents showing evidence of the information recorded under paragraphs (a) and (b) and subparagraphs (c)(i) to (vi) and (d)(i) to (vii) |
| 89(2) | Documents referred to in subparagraphs (1)(c)(vii) and (d)(viii) must be kept for two years after the day they are prepared |
| 89(4), (5), (6) | Additional content for importers, exporters and post-mortem programs |
For a food manufacturer making product for interprovincial trade or export, the working set is paragraphs (a), (b) and (e) plus subparagraphs (c)(i) to (vii) and the two-year retention rule — the same mapping the CFIA's own guidance sets out in a table of PCP content by activity.
Two related clocks are worth noting alongside the two-year rule. Section 48 addresses low-acid food in a hermetically sealed package, where an operator must apply the scheduled process and, for batch thermal treatment, use a temperature-sensitive indicator that visually indicates the package has been thermally treated; the retention provisions for records tied to a scheduled process run to three years. And section 87 sets the boundary for growers and harvesters of fresh fruits or vegetables: a written plan is required where the product is to be exported and an export certificate or other document is sought, or where the product is to be sent from one province to another and gross sales derived from food exceeded $100,000 for the previous 12 months.
How do the Canadian, Ontario and US rules differ — and do they overlap?
Canadian food businesses often work against more than one rulebook: the federal regulations, the provincial premises rules where they operate, and, for exporters, the requirements of a destination market. These instruments overlap but they are not equivalents.
| Canada — federal | Ontario — provincial | United States — federal | |
|---|---|---|---|
| Instrument | Safe Food for Canadians Regulations, SOR/2018-108, Part 4 (sections 45–89) | O. Reg. 493/17 (Food Premises) under the Health Protection and Promotion Act | 21 CFR Part 117, current good manufacturing practice, hazard analysis and risk-based preventive controls for human food |
| Scope | Licence holders making, importing, exporting or moving food interprovincially; slaughter; storing and handling imported edible meat products | Food premises operating in Ontario, covering premises, equipment, sanitary facilities and food handling practices | Facilities that manufacture, process, pack or hold food for US consumption, subject to its own exemption structure |
| Plan instrument | Preventive control plan (PCP) with hazard analysis, critical control points, critical limits, monitoring, corrective actions and verification | Operating and premises requirements enforced against the establishment rather than a plan document | Food safety plan with hazard analysis, preventive controls, monitoring, corrective actions, verification and a recall plan |
| Records | Two years for the substantiating documents under section 89(2); longer for scheduled-process records | Retention and inspection duties set by the provincial regulation and its guidance | Retention set by the applicable sections of Part 117 |
| Practical consequence | Interprovincial and export businesses are designed around Part 4; the plan is the auditable artefact | Premises and practices are inspected in the province; the provincial rules do not replace the federal plan duty | Exporters to the US need the US plan in addition to their Canadian plan, not instead of it |
The practical point is straightforward: a facility that treats these as one interchangeable set of hygiene rules ends up with a plan that satisfies none of them cleanly. Part 4's own language is about outcomes — clean and sanitary, appropriate, sufficient, recorded — and the plan has to show how those outcomes are achieved for the specific activities on the licence.
What does each duty generate on the floor as supplies and records?
Most Part 4 obligations are met partly by procedures and partly by supplies. The table below maps the sections to the consumable categories they typically drive. It lists categories and formats, not a purchasing decision.
| Part 4 duty | Consumable category it drives | What to keep evidence of |
|---|---|---|
| 50 clean and sanitary condition; 57 cleanable interiors | Disinfectants and sanitizers appropriate to the surface and the food, cleaning tools reserved for food areas | Sanitation records, chemical labels and safety data, concentration checks |
| 52 sanitizer identification and use per manufacturer instructions | Labelled chemical containers, dilution and test-strip supplies | Sanitizer concentration logs against the manufacturer's stated range |
| 53 equipment able to withstand repeated cleaning and sanitizing | Cleanable, durable equipment surfaces and parts, plus spare parts that keep instruments calibrated | Calibration records for instruments that control, indicate or record parameters |
| 63–64 lighting and ventilation | Cleanable light fixtures and ventilation components, replacement filters | Maintenance records showing ventilation functions as intended |
| 65 temperature and humidity control and recording | Monitoring instruments and data loggers able to indicate and record readings | Temperature and humidity logs, retained |
| 66 waste removal and disposal | Waste containers and bags suitable for the material and the disposal route | Waste removal and disposal records |
| 67 hand cleaning and sanitizing stations | Soap, hand sanitizer, towels, signage, dispensers able to withstand repeated cleaning | Station checks confirming supplies are stocked and accessible |
| 70–71 water, steam and ice | Water testing consumables and consumables that contact food safely | Water quality results and utility capacity evidence |
| 75 competencies; 76 clothing, footwear and protective coverings | Gloves, hairnets, beard nets, smocks, footwear that suit the area's hygiene controls | Training and competency records, plus PPE change-out practice |
| 77 personal cleanliness | Hand hygiene supplies at the point of use, in quantities that match the four required moments | Hand hygiene verification and supply replenishment records |
| 79 objects and substances | Detectable plasters and area-specific rules for personal items | Documented policy and observed compliance |
| 82–84 investigation, complaints and recall | Traceability and recall consumables: labels, lot identification, sample containers and transport bags for any product sampling | Complaint log, investigation records, recall simulation record with named contacts |
| 47 and 89(1)(c) hazard analysis and verification | Environmental and product sampling supplies — swabs, sample containers and transport bags — plus sterilization monitoring for laboratory media and equipment used in verification | Sampling results, plus sterilizer monitoring and lab controls |
Where a food facility runs its own laboratory for environmental or product verification, the sterilization and monitoring consumables used to prepare media, glassware and sampling equipment sit inside the section 89(1)(c)(vi) verification duty — the evidence that control measures are effective has to come from something that itself is controlled. Facilities in this position typically use sterilization monitoring consumables that match their lab's cycle profile, and a smaller trial format is a way to check the quarantine-and-read workflow before committing a lab to a full-size pack.
How long do preventive control records have to be kept?
Three recordkeeping rules do most of the work in an audit, and they are easy to state.
The two-year rule: documents that substantiate implementation of the food-safety content — the subparagraphs (c)(i) to (vi) evidence listed in 89(1)(c)(vii) — must be kept for two years after the day they are prepared. Scheduled-process records carry the longer three-year clock.
The complaint rule: section 83 requires a documented procedure for receiving, investigating and responding to complaints, which means the log and the responses are part of the plan's evidence rather than a customer service matter.
The recall rule: section 84 requires a document that enables effective recall and, explicitly, the name of the contact person responsible for the procedure and the name of the contact person responsible for conducting recalls. A recall procedure without named, current contacts is a document that fails on its own terms.
Where do food facilities most often lose ground in an audit?
Four failure patterns recur across Part 4 sections, and each has a cheap fix before an inspection finds it.
Sanitary condition treated as an impression. Section 50 sets a state, not an activity. The evidence is a sanitation record with what was cleaned, with what, and the verification result — not a schedule on a wall.
Sanitizers handled without the manufacturer's instruction sheet. Section 52 ties use directly to the manufacturer's instructions, which makes dilution, contact time and compatibility part of the regulated requirement.
Instruments that record but are never calibrated. Sections 53 and 65 require instruments that can control, indicate and record; the calibration practice in section 53(g) is what keeps those records meaningful.
Protective coverings specified for cost rather than for the area. Section 76 names gloves, a hairnet, a beard net and a smock, and requires them to be in good, clean and sanitary condition and appropriate for the activity — which is a change-out and specification question, not only a purchase order.
Related reading
- What does the CFIA preventive control plan require?
- Ontario Regulation 493/17 and the CFIA preventive control plan compared
- HACCP, FSSC 22000 and SQF in Canada: what food manufacturers actually need to do
- Food plant hygiene programmes: PPE and cleaning under CFIA rules
- Case review: a Manitoba food plant's 3-wall specimen bag leak failures
Frequently Asked Questions
Which sections of the Safe Food for Canadians Regulations make up Part 4?
Part 4 runs from section 45 to section 89 and is organised into six divisions: Interpretation and Application (45–46), Biological, Chemical and Physical Hazards (47), Treatments and Processes (48), Maintenance and Operation of Establishment (49–81), Investigation, Notification, Complaints and Recall (82–85), and Preventive Control Plan (86–89).
Who needs a written preventive control plan?
Section 86 requires a licence holder to prepare, keep and maintain a written plan meeting section 89 for each activity identified in their licence. The CFIA's guidance lists the activities that generally trigger the requirement, including manufacturing, processing, treating, preserving, grading, packaging or labelling food for interprovincial trade, importing food, slaughtering food animals, and growing or harvesting fresh fruits or vegetables for interprovincial trade. The same guidance notes that some businesses, such as those with annual gross food sales of $100,000 or less, may not be required to have a written plan.
How long do preventive control plan records have to be kept?
Documents referred to in subparagraphs 89(1)(c)(vii) and (d)(viii) — the material that substantiates the plan has been implemented — must be kept for two years after the day they are prepared. Records tied to a scheduled process for low-acid food follow a longer retention period of three years after the most recent application of the scheduled process.
Does the plan have to include a recall procedure?
Yes. Section 84 requires a document setting out a recall procedure that enables effective recall, along with the name of the contact person responsible for the procedure and the name of the contact person responsible for conducting recalls. Section 82 also requires immediate investigation when an operator suspects on reasonable grounds that a food presents a risk of injury to human health or does not meet the requirements.
What protective equipment does Part 4 require in a food area?
Section 76 requires anyone entering or in an area where food is manufactured, prepared, stored, packaged or labelled to wear clothing, footwear and protective coverings — including gloves, a hairnet, a beard net and a smock — that are in good, clean and sanitary condition and appropriate for the food and the activity. Section 77 adds personal cleanliness, including hand cleaning and, where necessary, sanitizing at four defined moments.
Do temperature and humidity readings have to be recorded?
Where a facility has a heating, cooling or humidity-control system, section 65(2) requires it to be equipped with instruments to control, indicate and record temperature and humidity levels if that is necessary to prevent contamination of a food. Section 53 makes a parallel requirement for conveyances and equipment: instruments to control, indicate and record the parameters necessary to prevent contamination, maintained and calibrated in accordance with the manufacturer's instructions.
Is Part 4 the same as HACCP?
Part 4 requires hazard identification and analysis and a plan containing critical control points, critical limits, monitoring, corrective actions and verification — the architecture associated with HACCP — but it is a legal instrument with specific numbered duties, including premises, hygiene and equipment requirements that sit outside a classic HACCP plan. Certification schemes such as FSSC 22000 or SQF are separate certification programmes that sit alongside the regulatory baseline.
CliniEco Medical supplies infection-control and protective consumables to Canadian food processing facilities, laboratories, clinics and long-term care homes — MDEL #35334. Facilities working through Part 4 content typically review food-safe nitrile gloves, disposable hairnets and 3-wall specimen transport bags for sampling programmes, with the smaller 5-pack trial format available where a plant laboratory wants to trial sterilization monitoring before standardising. Facility-level purchasing runs through the wholesale account page, with the wider laboratory consumables range supporting sampling and verification work.
Sources
- Safe Food for Canadians Regulations, SOR/2018-108 — full text (Justice Laws)
- Safe Food for Canadians Regulations — table of contents showing Part 4 beginning at section 45
- CFIA — Preventive controls and preventive control plans: requirements for food businesses in Canada
- CFIA — Regulatory requirements: preventive control plan for food businesses
- Ontario — O. Reg. 493/17: Food Premises
- US — 21 CFR Part 117, current good manufacturing practice, hazard analysis and risk-based preventive controls for human food
- US — 21 CFR 117.135, preventive controls
- CliniEco Medical laboratory consumables
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