Archived - Guidance document for on-farm dairy processing operations
Registration and operational requirements

Introduction and scope

This document is an interpretation/supplementation to the Dairy Establishment Inspection Manual (DEIM) to provide guidance for operators of on-farm processing facilities considering federal registration. This document contains a combination of regulatory requirements that are required by the Dairy Products Regulations and policy guidelines as outlined in the DEIM. It is recommended that the operator consults the Canadian Food Inspection Agency (CFIA) in the early planning stages of the project.

Note: In conjunction with this document the DEIM should be referenced and consulted for more detail in order to fully evaluate the programs, equipment, good manufacturing practices, and environmental conditions of on-farm dairy establishments in order to assess their capability to produce safe and wholesome products. On-farm processing operations are considered higher risk than other processing establishments due to environmental concerns, and as such require clearer direction on what is required to produce a safe product. A well designed facility, managed by qualified personnel and sound operational procedures and programs can mitigate the risks of these on farm processing operations. No one guideline alone can assure the safety of the product, however each in conjunction with the others can help to mitigate and control the risks to the product from the inherent potential contamination of the farm environment.

Provincial regulatory requirements must also be met. It is important that the operator contact the Provincial authorities for these requirements.

Registration package

(DEIM 3.5.1)

All registration documents are to be completed and signed by the applicant. A registration package is to include the following:

1. Application for Registration of an Establishment CFIA/ACIA 3043: Application for Registration of an establishment forms may be obtained from any CFIA Office or on line. An application for registration of a dairy processing establishment is to be made by the applicant, in writing, to the Regional Director, CFIA, in the Region where the establishment will be located. This form is to be completed in full on both sides following the directions on the form. (Dairy Products Regulations 10.(1))
2. Municipal, Provincial or Federal Documents: A copy of the federal or provincial documents of incorporation, partnership or proof of business name must be attached, as indicated on the application form. If the company is neither incorporated nor a partnership, a notarized affidavit must be attached showing the name under which the establishment will operate. The name provided on the provincial business registration or affidavit must be the same as identified on all documents presented for registration purposes. (Dairy Products Regulations 10.(1)(a), (b), (c), (d), (e), (f))

   The applicant must give written assurance that the location, construction, facilities and nature of operation are in accordance with all municipal, provincial and federal requirements. This may require submission of a building permit, as well as written assurance from the appropriate authorities indicating compliance with environmental requirements (for example wet land drainage systems).

3. Dairy Plant Information and Registration of an Establishment Record: This form is to be completed and signed by the applicant. (Location of the form can be found in the DEIM Chapter 3 - Appendix 3 - 3).
4. Registration Fee: As prescribed in the Canadian Food Inspection Agency Fees Notice, Part 1 - Dairy Products Fees under the Canadian Food Inspection Agency Act, accompanied by validation of volume of milk the establishment will receive or production output during the 12 months following the date of application. For establishments receiving a volume of milk less than 100 000 hl, the current annual fee is $895. (Dairy Products Regulations 10.(1)(g))
5. Plans and Specifications (Dairy Products Regulations, Section 10. (2)(a)):
   • Site plans showing boundaries of the site, the location of the dairy establishment in relation to all buildings, structures, roadways, driveways (including parking sites), railway lines, sewer lines, wells, public utilities and all manure storage areas, if applicable on the property. The scale and the north point are also to be shown. The site plan must also include the legal name and address of the company (Dairy Products Regulations 10 (2)(v)). The CFIA should be consulted during the planning stages of the project to verify the acceptability of the location of the facility on the site.
   • Blueprints/building plans. A hand drawn plan may be acceptable if it is neat, complete, legible and drawn to scale; diagrams are acceptable. The plan is to include a legend of the symbols used and the name and address of the company. The plan must show:
     • A floor plan of each level of the establishment showing the dimensions and function of each room or area (Dairy Products Regulations 10.(2)(i);
     • The location of walls, partitions, windows and doors, stairs and drains, including any other openings (e.g. hose ports and exhaust fans) (Dairy Products Regulations 10.(2)(i);
     • The descriptions of the materials used in the construction of all the equipment, floors, walls, ceilings and openings (Dairy Products Regulations 10.(2)(iv);
     • The descriptions of the types and location of the equipment (Dairy Products Regulations 10.(2)(iii);
     • The descriptions of the lighting, refrigeration, ventilation and plumbing (surface and floor) systems (Dairy Products Regulations 10.(2)(ii));
     • Product and personnel flow patterns throughout the establishment, from receiving to processing to packaging to storage and distribution (DEIM 1.10.01.02, DEIM 1.10.04.02).

     Plans and specifications are to be agreed to by all parties, before commencement of any construction to avoid unnecessary expense and inconvenience to the applicant.

     Where additions, extensions or renovations planned for a registered dairy establishment involve changes to the blueprints on file, revised blueprints are to be submitted to the CFIA inspector prior to construction showing the changes and the impact of these changes on the surrounding rooms. Where an establishment wishes to make changes to the location of the equipment, product flow patterns and/or personnel flow, changes to air flow, changes to the critical process equipment, changes to the activities or products being produced, the proposed changes are first to be reviewed by the CFIA inspector (Dairy Products Regulations 11.1 (29)).

6. Sanitation Program (Dairy Products Regulations Section 10. (2)(b)) (DEIM 1.10.05): For the purpose of registration, an outline of a Sanitation Program which includes:
   • The person responsible for carrying out the program,
   • The equipment and chemical agents to be used to bring about and maintain clean and sanitary conditions. The responsibility remains with industry to ensure that all non-food chemicals used in an establishment are safe and effective, meet all regulatory requirements, are handled in a manner that prevents contamination and in accordance with the manufacturer's instructions.
   • The measures proposed (description of the tasks, including frequency of conducting the tasks and how the task is conducted) to be taken to ensure clean and sanitary conditions.
7. Pest Control Program (Dairy Products Regulations Section 11.1(10)) (DEIM 1.10.05.04): The pest control program is to indicate the measures to be taken to effectively and safely control insects and rodents and exclude any animals from the registered establishment.
8. Recall Program (DEIM 1.10.06): A recall program is required to ensure an effective recall of any lot of food from the market. It includes:
   • The person responsible for carrying out the program,
   • The coding system description,
   • The notification and other procedures to effect the recall.
9. Water Analysis (DEIM 1.10.01.09, Dairy Products Regulations 11. (2)(k)): It includes:
   • The source of the water and verification that the water source is acceptable prior to registration. If the source is a well, the sampling is to be undertaken by the operator, with the analysis (done at a provincially approved laboratory) as follows:
     • Chemical testing - range of chemicals will depend on local conditions, such as geological formation, seepage from fertilizers, pesticides or local exposure to industrial pollution. The Provincial Environmental authorities should be consulted to establish the range of tests to be completed.
     • Microbiological Testing - total coliform and E. coli.
   • A current certificate of water analysis showing acceptable results for bacteriological and chemical analysis provided by a provincially approved laboratory.
10. A list of products produced by the establishment.
11. Microbiological product and environmental monitoring program (DEIM 1.10.07.01, DEIM 1.10.07.03): A program is required to indicate measures to be taken to ensure microbiological control over the product and the environment.

Before registration is recommended by the Inspector, a pre-registration inspection will be conducted by the CFIA to ensure the dairy establishment has provided all the necessary documents, the establishment has been constructed and equipped in accordance with the plans and all registration requirements are satisfied. An in-depth inspection will be completed within 3 months of registration.

The operator needs to be aware of the various sources of potential contamination on their farm, how these sources could lead to contamination of the product and what mitigating steps need to be in place to minimize this risk. The operator needs to be capable of manufacturing safe products in the on-farm environment they have chosen. The implementation of the following operational requirements will help to mitigate and control the risks to the product from the inherent potential contamination risks associated with a farm environment:

Premises

(DEIM 1.10.01)

The premises (processing facility) includes all elements in and around the building, including, the outside property, roadways, drainage, building design and construction, product and personnel flow, sanitary facilities and water quality.

Surroundings and Outside Property

(DEIM 1.10.01.03)

The very nature of an on-farm processing facility's location may result in increased risks to the product as opposed to facilities that are not on-farm. It is for this reason that potential sources of contamination must be considered when deciding on the location of the dairy processing establishment on the farm.

• The establishment is not to be located where conditions may result in a threat to food safety. For example, the establishment is to be located away from:
  • environmentally polluted areas and industrial activities,
  • areas that are not free from objectionable odours (e.g. located as far away as possible from animal housing, manure storage areas and upwind of the prevailing winds relative to any sources of contamination),
  • areas subject to flooding or run off unless safeguards are provided (e.g. not located in low lying areas),
  • areas prone to infestations of pests,
  • areas of waste disposal facilities.
• The establishment is to be separate from barns, livestock housing, living quarters and other incompatible operations. A guideline of 30 metres distance is suggested however this may vary depending on the risk to the product and what measures are in place to control the hazards. It is the responsibility of the operator to mitigate risks to the product and control the odour, air flow, dust and other environmental hazards.
• The site is to have good drainage and provide a suitable base for construction of the dairy establishment. It is expected that precautions will be taken (e.g. soil sampling) to assure that structures are built on the best possible foundation in order to minimize settling and sagging of the building.
• There should be no free roaming animals including livestock and family pets in the vicinity of the plant.
• The area immediately surrounding the building is to be maintained in a neat and orderly manner. It is to be free of tall grass, debris and other materials (e.g. equipment, pallets, tires, building materials, bales of hay or straw, vehicles) likely to be a breeding place for flies or rodents or be the cause of any other objectionable conditions.
• The surrounding property should be adequately drained to prevent flooding and run-off.

Rationale:

Hazards which may contaminate dairy products in a farm environment (for example barn odours, fumes from chemical sprays) need to be effectively controlled. Presence of pests in the dairy establishment increases the likelihood of dairy product contamination.

Roadways, Driveways, Parking Lots

(DEIM 1.10.01.03):

Roadways, driveways and parking lots must be maintained to minimize environmental hazards.

• Roadways, driveways and parking lots on the premises are to be properly graded, compacted, dustproofed and drained. These should be of a material and grade that will not allow free standing water or mud to accumulate in wet weather.
• There should be a separate driveway to and from the barn away from the main access driveway. At the very least, the roadways for access to the establishment should be such that any vehicles to the establishment do not cross over contaminated areas by livestock wastes or farm vehicle traffic.

Rationale:

Depending on the time of year and weather conditions, barn yards and roadways can become messy from equipment travelling back and forth, manure from spreading operations, mud from farm equipment, etc.

Dairy Establishment Layout and Design

(DEIM 1.10.01.02)

The dairy establishment is to be designed to provide a good flow of product, employees and equipment to minimize the risk of cross contamination. The design is to provide a hygienic progression from the point where the milk enters the establishment to finished product shipping.

• Up-to-date blueprints/building plans (as described above) must be available on site.
• A sufficient number of rooms to accommodate separation of incompatible operations are required. Some examples of incompatible operations include: raw milk receiving, storage and processing rooms, raw milk/pasteurized milk, raw cheese/pasteurized cheese, raw product/pasteurized product undergoing maturation or ripening.
• Each room needs adequate space to allow access during processing and access around equipment in order to perform proper maintenance and effective cleaning and sanitizing of equipment, floors, walls and ceilings.
• If aging caves (man-made underground caves) are used, adequate ventilation, drainage, temperature and humidity controls are required to prevent condensation and water pooling issues.
• Equipment and pipelines should be installed so that the integrity of the processing and the CIP system is not compromised. For example, where there are direct pipelines transporting product from the barn to the establishment, the plant CIP system for pasteurized product cannot be used for the CIP cleaning and sanitizing of the pipeline from the barn. It would be acceptable to use either the barn CIP system or the raw milk receiving CIP system from the plant. This pipeline is to be able to be open and accessible for inspection, preferably located above ground. It is to be a permanent, rigid, stainless steel line, adequately supported so that there are no dips in the line and sloped to enable draining of the line. The requirements for this pipeline are important to the integrity of the raw milk being transported within these pipelines. Lengthy pipelines are difficult to clean which may lead to a build-up of biofilm. Initial validation and periodic verification of the cleaning effectiveness is required on these lengthy pipelines. Where a pipeline is not feasible, a tank vehicle could be used to transport milk from the milking house to the dairy processing facility.
• Complete segregation of incompatible products such as raw materials and pasteurized food products, cleaning products and food products and waste materials and food products is needed. Some small facilities using vat pasteurizers for thermal processing may also want to use these vats for finished product holding/ripening. In these cases, there must be a policy in place to mitigate the risks. These units must meet the all requirements of Chapter 12 DEIM Batch Pasteurization. In addition, there can be no raw product in the same room at the same time as pasteurized product, including in tanks, pumps, pipelines, drains. Segregation of raw product from pasteurized product during processing could also be accomplished by time separation of the different processes.
• Where raw milk cheeses and pasteurized milk cheeses are manufactured in the same establishment there should be a physical separation of these processes (e.g. separate brine tanks, separate curing shelves) which can include area (space) or time. The raw milk cheeses should always be made after the pasteurized milk cheeses.
• Establishments that sell their product directly to customers must have a separate room for the sale of their product that does not allow entry of visitors to the processing areas and a policy to control personnel and product movement between these areas.
• If a public washroom is required, the operator should check with the municipality or local health unit for building code requirements for the public washroom. The public are not to use washroom facilities dedicated for dairy establishment personnel.
• Movement of employees is to be strictly controlled between the farm (including the milking parlour) and the dairy establishment. It is strongly recommended that there is clear separation of on-farm and dairy plant personnel and duties to minimize cross contamination from workers.
• If it is necessary for employees to enter the establishment after being in the barn (e.g. in emergency situations, employees illness), a written program should be in place to mitigate the risks of cross-contamination from workers. The program would outline the procedures the worker would follow before entering the dairy establishment (e.g. washing, changing into dairy plant clothing, hair restraints and dedicated footwear).
• Outer clothing and footwear must be changed prior to entering the processing facility. For example, barn boots and barn clothing are not allowed in the dairy processing portion of the establishment. A separate change area and storage location for barn clothing and barn boots is suggested prior to entry into the facility. This could be done in a vestibule area, with doors entering and leaving that provide for the transition between the farm environment and the plant environment. This area could be where a change in outer clothing and footwear could occur and be designed so that the two sets of clothing and footwear remain separate from each other. Well maintained footbaths should be placed at the entrance to the processing facility.
• It is suggested to structure the workday to minimize the number of times personnel exit and return again to the establishment. For example, operations should be started and completed before exiting the establishment.
• In planning construction of a registered dairy establishment, consideration should be given to possible future expansion such that it would not cause serious congestion or other disruption to the flow of the operation.

Rationale:

Attention to good hygienic design and adequate facilities is necessary to enable effective control of hazards and prevent the introduction of pathogens into the establishment.

General Construction Requirements

(DEIM 1.10.01.04):

Floors, Walls and Ceilings

Structures within dairy establishments need to be built of durable materials and be easy to maintain, clean and disinfect. The following conditions are necessary to protect the safety of food:

• The responsibility remains with Industry to ensure that all construction materials used in an establishment are safe and effective and meet all regulatory requirements
• Walls and ceilings are smooth, hard, impervious to moisture, washable. Light coloured walls and ceiling are preferred as they facilitate the identification of unclean areas.
• Examples of accepted materials for walls and ceilings include glass board panels, glazed tiles and smooth steel. Examples of unacceptable materials are painted plywood, drywall and porous, acoustic-type boards. While the surface finishes of walls and ceilings are most important, the durability of the underlying structures is also a concern.
• Walls are to be free of pitting, cracks, crevices and ledges and kept in good repair.
• Wall-floor joints need to be well joined or coved to facilitate cleaning and prevent contamination.
• Floors of all rooms where dairy products are received, processed or stored may be constructed of sealed concrete or some other impervious, cleanable material. Floors in storage rooms for storing dry ingredients or packaging materials or utility rooms are to be smooth and cleanable. Materials should not be stored directly on floors. Materials can be stored on clean, well maintained pallets.
• Floors need to be adequately sloped to provide good drainage of liquids to sufficiently sized trapped outlets (For example, ¼ inch per foot or 2% if feasible, depending on the size of the room,). Pooling of liquids on the floor must be avoided at all times as they provide a source of microbiological growth.
• The above construction material requirements apply to processing and product storage areas within the dairy establishment. A greater variety of construction materials may be permitted in other areas of the establishment such as office, lunchroom and washroom as long as sanitation is not jeopardized.

Rationale:

Properly finished walls, ceilings and floors are more easily cleaned and sanitized, which will minimize the risk of contamination of dairy products from environmental sources.

Utility Lines and Conduits

• Must be suspended away from work areas or areas of exposed dairy products.
• Clean, identified, free of flaking paint.
• Where appropriate, insulated to prevent condensation.
• Lines carrying contaminated or hazardous materials, such as sewer lines or floor drain lines, are to be located away from any product or product contact surfaces.

Rationale:

Dripping condensate or excessive dust from overhead utility lines can act as a potential source of contamination when suspended over work areas or areas of exposed product.

Doors and Windows

• Doors are to be close-fitting and constructed to withstand the rigours of normal use, with a smooth, non-absorbent surface, easy to clean.
• Doors should either be of a rust-resistant metal or other acceptable construction material.
• Doors leading to the outside or other applicable areas, e.g. processing room, washroom shall be self-closing and tight-fitting. Doors to the outside are to be kept closed at all times. Exterior doors do not open directly into an area where there is exposed product (e.g. processing areas, storing/aging rooms, packaging rooms).
• Doors, windows and all other openings leading to the outside shall be pest proofed with effective means such as screening, fans, air curtains or any other material which prevents the entrance of pests.
• Windows should be easy to clean, constructed to minimize the build-up of dirt and if necessary be fitted with removable and cleanable insect-proof screens. If not properly screened, windows are to be sealed and kept closed at all times.
• Glass windows, including those in doors are protected against breakage in critical areas. (Establishment has a glass breakage policy. Refer to DEIM 1.10.01.11).

Rationale:

Pests may carry pathogenic organisms on and within their bodies which could be spread throughout the establishment and including on the equipment. Properly closed windows and doors prevent dust, farm odours and chemical fumes from entering the processing areas.

Paint/Coatings

• The use of paints in processing and storage areas may not be the best option due to the need for increased maintenance over time, however if used, any paints and coatings intended for use in food production and storage areas must be safe and meet regulatory requirements.
• The painting of food product contact surfaces is prohibited.

Rationale:

Properly finished surfaces will minimize the risk of contamination to dairy products by permitting thorough cleaning and sanitizing and reducing moisture absorption which could contribute to microbial growth.

Lighting

• Proper illumination is important for the safe food handling and thorough cleaning of the area. Both natural and artificial lighting are acceptable. Intensity (measured with a light meter at a distance of 75 cm from the floor) as follows:
  • Grading and inspection areas and product inspection areas in a lab must have a minimum illumination of 540 lux (50 foot candles);
  • General processing areas, e.g. filling and equipment cleaning areas or work areas must have a minimum illumination of 220 lux (20 foot candles);
  • All other areas must have a minimum illumination of 110 lux (10 foot candles).
• Lighting is designed to prevent accumulation of dirt, be cleanable and shielded with shatterproof coverings where dairy products, ingredients, food additives or packaging materials are exposed. (Establishment has a glass breakage policy. Refer to DEIM 1.10.01.11).

Rationale:

The shielding of lights is necessary to prevent the contamination of dairy products from glass fragments in the event of breakage. Adequate lighting promotes cleanliness by facilitating the identification of unclean areas.

Ventilation

(DEIM 1.10.01.04, DEIM 1.10.01.10, DEIM 1.10.03.02)

• Dairy establishments need to have adequate ventilation to provide a sufficient exchange of air in all parts of the establishment and to keep the air fresh and free of objectionable odours, dust, steam and vapour. Air for ventilation should be filtered or otherwise treated to remove all environmental contaminants. For example, HEPA (High Efficiency Particulate Air) filtration may be required depending on the surrounding conditions and risk to the product.
• Ventilation is sufficient to keep equipment, walls, ceilings and overhead structures free of condensation and mould growth. Additional venting capabilities may be needed in areas where excessive heat and/or moisture are being generated (e.g. furnace/boiler rooms, open ricotta kettles, Ghee tanks, COP tanks).
• Air intakes and filters should be properly located to be effective in preventing the entry of dust or objectionable odours.
• Ventilation system is designed and constructed so that the air flow is from the processing areas (positive pressure) outward to other areas of the plant.
• Direct air movement onto product, product contact surfaces or filling and packaging areas is to be avoided unless properly filtered.
• If there is a laboratory in the facility that is not isolated from the processing areas and is conducting micro testing the laboratory must have negative pressure.

Rationale:

Unclean air, excessive dust, odours, or build-up of condensation are all potential sources of contamination for dairy products. The air supply must not contaminate the equipment or the dairy products.

Drains

• Adequate drainage must be installed throughout the establishment.
• The number, size and location will depend on the nature of the establishment and will need to be sufficient in areas of high water discharge to prevent the pooling of water, milk or other processing waste.
• Drains must be individually trapped and vented. Acceptable types of traps include U or P type traps.
• Drain lines shall be sloped and equipped with effective rodent screens.
• Drains shall be equipped with removable covers and located so that they are accessible for cleaning and sanitizing. Interior surfaces of trench drains are smooth and easy to clean.

Rationale:

Properly designed drains and drain lines reduces the likelihood of an unclean environment and contamination of dairy products. Trapping and venting of drains prevents sewer gases and pests from entering the plant.

Sewage and Wastewater Disposal

(DEIM 1.10.01.04 and DEIM 1.10.01.05)

• The sewage system shall be designed so that the effluent of human waste does not cross-connect with any other waste effluent system in the establishment. Under no circumstance may human waste empty into a catch basin.
• Sewage must be disposed of in a sanitary manner.
• All privately constructed and operated sewage and waste treatment systems, for example wetland technology (i.e. man-made marshes), septic technology, etc. should meet all environmental and municipal requirements. Contact should be made to local municipalities to obtain proper approvals, licences, etc.
• Consideration should be given to protect living wastewater and sewage systems from the detrimental effect of chemicals and other contaminants or have an appropriate alternative of disposal in the event of a problem with the sewage and waste treatment system.
• There shall be no cross-connection between the drains or drain lines and the water supply, the dairy product lines or equipment or CIP system.
• Overhead drain lines or sewer lines shall not pass directly over or through production areas.
• All drainage systems must be sub-surface and local and provincial ordinances and codes must be observed.

Rationale:

Properly designed systems will reduce the likelihood of contamination to the dairy establishment environment and prevent the introduction of pathogens.

Garbage and Waste Disposal

(DEIM 1.10.01.05)

• There must be a separate area that is suitable for the storage of garbage prior to disposal. If it is a separate room within the establishment, it is to be emptied daily and be cleanable. Ventilation may be required if odours are a problem. If it is a garbage container outside the establishment, it must not attract pests, be in good condition and the lid is to be kept closed. Liquids draining from the garbage must not pool outside the facility.
• Combustible wastes are not to be burned in the vicinity of the establishment in order to avoid contamination of the facility by ash and odours.
• Within the establishment, there must be a sufficient number of garbage containers so they are accessible to employees. These containers are to be clearly identified, leak proof, emptied regularly and cleaned and sanitized prior to use and used only for garbage.
• Whey disposal must not pollute the environment or cause any unsanitary conditions within and outside the establishment. It must be free of flies, insects and objectionable odours. If an outside storage tank is used it should be set up on a concrete platform, washable, well drained, sloped and kept clean.

Rationale:

Adequate waste management will minimize the presence of pests and decaying product inside and outside of the dairy establishment, reducing the likelihood of dairy product contamination.

Hand Washing Facilities

(DEIM 1.10.01.06)

• In production areas these should be of the remote-control type (foot, knee activated or timed) with trapped waste pipes to the drain.
• Equipped with liquid or other type of soap dispensers, paper towels in suitable dispensers and used towel receptacles that are properly constructed. Roller-type cloth towels are not acceptable.
• Convenient and accessible and close to product handling areas as well as at the entrance to production areas.
• Sanitizing facilities are available in areas where personnel are in direct contact with product.
• Hand washing signs are posted in all product handling areas.

Rationale:

Proper use of hand washing facilities is essential to reduce the likelihood of contamination of dairy products. Poor hand washing is known to be a major contributing factor in outbreaks of foodborne illness.

Employee Facilities / Employee Hygiene and Health

(DEIM 1.10.01.06) / (DEIM 1.10.04.03)

• Washrooms and change rooms are provided for the exclusive use of the dairy establishment personnel. The washrooms in the establishment are not for public use. Barn clothes and barn boots are not to be worn or stored in the dairy facility. Washrooms and change rooms must be considered when designing the layout of the dairy establishment.
• Eating or drinking is not permitted in any area where dairy products are prepared; therefore lunchrooms are also required in dairy establishments where personnel not living on the farm are employed in the processing facility.
• Washroom, change room and lunchroom (if applicable) facilities shall not open directly into an area used for receiving, processing or storing of dairy products. Doors are to be self-closing and tight-fitting.
• Washrooms must have hot and cold potable running water, soap dispensers, soap, sanitary hand drying equipment or supplies and a clean waste receptacle. They must be easily cleanable and provided with properly drained floors and effective, negative ventilation vented directly to the outside.
• Hand washing signs are posted in washrooms.
• Plumbing shall meet the applicable provisions of the provincial or local plumbing codes.

The cleaning (washing) of employee clothing is not permitted to be done in the home of the operator. The laundry shall be sourced out to an external cleaning company or done in laundry facilities in the establishment which are used solely for processing facility laundry. It is recommended that employee clothing be white or light coloured as this gives the appearance of clean and sanitary and identifies plant personnel. It is recommended that hair nets used are obvious and shower type, as these types can be easily seen and completely cover the hair.

Rationale:

Properly designed, located and maintained sanitary facilities are necessary to protect dairy products, equipment and containers from fecal contamination which may be carried by insects, hands or clothing; reduces the chance for the spread of contamination; and reduces the risk of contamination into the processing areas by way of air and pests.

Non-Processing Areas

(DEIM 1.10.01.08)

• Facilities for equipment cleaning and sanitizing facilities (Clean-Out-Of-Place (COP)):
  • Adequately separated from food storage, processing and packaging areas.
  • Facilities constructed of corrosion resistant materials and are easily cleaned.
  • Potable water with adequate temperatures for chemical usage (as per usage instructions on label of cleaning chemicals). Generally a minimum of 60ºC is recommended when hot water is required.
  • During the cleaning process, temperature, time and chemical concentration monitored and recorded (either manually or with a recording chart)
  • The area must have adequate lighting, drainage and ventilation.
• Other Rooms (boiler, compressor, mechanical shops, retail outlets, etc.):
  • Adequately separated from food handling areas.
  • Properly maintained.
  • Free of pest harbourages.

Rationale:

Properly located, designed and constructed cleaning facilities and non-processing areas are necessary so as not to pose a contamination risk to food processing and handling areas and prevent hazards that might adversely affect the safety of a dairy product.

Non-Food Chemicals

(DEIM 1.10.02.08)

• Chemicals should be stored in a separate room or area, away from other supplies or materials (ingredients and packaging materials).
• The responsibility remains with Industry to ensure that all non-food chemicals used in an establishment are safe and effective and meet all regulatory requirements.
• The use of a coding system would be beneficial for identification of non-food chemicals.

Rationale:

Chemicals must not be allowed to become a potential source of contamination.

Water/Steam Quality and Supply

(DEIM 1.10.01.09, Appendix 19-12, Appendix 19-12A, Appendix 19-12B, Appendix 19-12C (under review), Appendix 19-12D (under review), Appendix 19-1)

• Water supply must be approved by the local or provincial regulatory agency.
• Where the supply of water is derived from a private well, adequate protection must be provided to the well head to prevent contamination of the water supply.
• Hot and cold water, under adequate pressure and in sufficient quantities to meet the needs of the facility is to be provided.
• The quality of the water must meet Health Canada's Guidelines for Canadian Drinking Water Quality.
• Additional chemical testing, following registration may be required if there is a change to the well or piping system of a private well or there is a specific chemical residue issue identified in the area of the well.
• For microbiological testing, a frequency of once per year at the source for total coliform and E. coli and once per month (at different sites) for in plant water for total coliform and E. coli must be completed to confirm potability. A 100 mL water sample is required for each test. Water is considered microbiologically safe if the maximum acceptable concentration for both total coliform and E. coli is non-detectable per 100 mL water sample.
• Water samples shall be tested at a government or accredited laboratory that uses acceptable test methodology.
• Only potable water shall be used in contact with product or product contact surfaces.
• Where non-potable water is used (for example, fire protection, boilers), there can be no possibility of a cross connection between potable and non-potable systems.
• There shall be no possibility of a cross connection between a potable water system and any source of pollution or contamination.
• If water is stored, storage facilities are designed, constructed and maintained to prevent contamination.
• Where automatic chlorinators are used, controls and procedures shall be established to ensure water potability. These include: the use of an automatic metering device for adding chlorine in the correct concentration and twice daily, tests shall be made using a reliable chlorine test kit to determine the free residual chlorine level. Records of residual chlorine tests shall be maintained.
• Steam may be used in an establishment for cleaning and sanitizing purposes and in the manufacturing process. If steam has direct contact with product and product contact surfaces it must be culinary type steam. The water used to produce steam is ultimately a food ingredient. This water must also meet potable water regulatory requirements. Of concern are the corrosion inhibitors and water conditioning compounds.
• Dairy establishments must have a complete written and fully documented program to ensure they are continuously using safe/potable water in the preparation and processing of food.

Rationale:

The water supply must be safe, sanitary and adequate at all times to avoid the contamination of dairy products, equipment and containers and to ensure, effective cleaning.

Glass breakage policy

(DEIM 1.10.01.11)

• If the establishment handles glass containers or has glass in manufacturing areas, e.g. glass windows, then a written glass breakage policy is required. The policy specifies procedures to be followed in cases of broken glass, designates responsible personnel and is updated as required.

Rationale:

The implementation of a glass breakage policy is necessary to reduce the likelihood of introducing a hazard which may adversely affect the safety of a dairy product.

Raw product acceptability

(DEIM 1.10.02.04)

• Antibiotic screening prior to processing of each lot of milk/cream is required. If the establishment is using milk from only their own herd and they have documentation to show the treatment of the animals and withdrawal times, antibiotic screening may not be necessary prior to the milk entering the establishment. If the establishment is receiving milk/cream from other herds then the screening of each lot is required prior to receiving the milk into the establishment.
• Raw milk/cream must be negative for the presence of veterinary drug residues and inhibitory substance residues as tested by an approved screening method or testing below the MRL by an approved quantitative method.
• In addition to antibiotic screening, raw product is monitored for microbiological standards, acidity, incoming temperature as per the National Dairy Code, Production and Processing Regulations or Provincial Regulations. Records for monitoring of raw product must be kept and available at the establishment.
• Temperature of incoming raw milk into the dairy establishment should not be greater than 4ºC. Milk coming directly from the barn and being processed within 2 hours (i.e. for cheese making) may be acceptable at higher temperatures. Time, temperature and processing parameters must be made available to the inspector for review and evaluation if milk is received at temperatures greater than 4ºC. Provincial requirements must be met.
• All raw milk shall be filtered at receiving prior to storage.
• There must be provisions in place for storing raw milk/cream if it is not processed immediately. The storage time/temperature must be controlled so that there is no detrimental effect on the quality and safety of the product. Raw milk/cream should not be stored longer than 72 hours at a temperature of 4ºC or less.
• If raw milk/cream (generally applies to sheep milk, because with other milks the protein coagulates out and causes damage to the milk) is being frozen to accumulate a larger volume for processing, proper procedures should be in place so that milk does not go through a period of freeze, thaw, and freeze prior to use. An establishment that stores frozen raw milk/cream and then tempers it from a frozen state will require a written protocol of how the product will be handled so as to minimize the growth of micro-organisms, including routine documented temperature checks and microbiological testing. Consideration should be given to the following:
  • Warm milk should not be poured directly onto frozen milk. It should be cooled to 4ºC before adding it to the frozen.
  • Raw milk that is to be frozen should be frozen within 72 hours and remains in a frozen state until it is going to be processed.
  • Each container of milk should be uniquely identified and a record kept by the processor so that the milk can be traced back to each producer.
  • When an establishment is tempering milk from the frozen state it must be done under controlled conditions.
  • After defrosting, every pail of milk from each producer should be inspected for odour and quality and all the milk is to be filtered prior to processing.
  • The freezer unit should be equipped with an accurate temperature measuring device. A daily record of freezer temperature shall be kept.
  • Re-useable milk storage containers must be thoroughly cleaned, sanitized and dried after emptying and before the next use. If used, pail liners shall only be used once. Containers shall be stored so that the exteriors remain clean and free of contaminants.
• Where more than one dairy species are being processed in the same facility, procedures are in place to prevent the unintentional mixing of the milk between dairy animal species.

Rationale:

Contamination of milk from animal and environmental sources during production should be minimized to reduce the risk of unsafe dairy products. Pathogen contamination and/or recontamination from poor handling procedures and growth of toxins from temperature abuse may cause a health hazard in the dairy product.

Equipment construction, design, installation and calibration

(DEIM 1.10.03.01, Chapter 11, Chapter 12 and Chapter 16)

• According to the Dairy Products Regulations (Section 11.(2)(n) and (o)) equipment must be constructed of corrosion resistant materials, free of noxious elements, capable of being cleaned, accessible for cleaning, maintenance and inspection or easily disassembled for those purposes, and effective for the purpose for which it is intended. Food contact surfaces are non-toxic, smooth and free from pitting, crevices and loose scale, unaffected by dairy products, capable of withstanding repeated exposure to normal cleaning and non-absorbent.
• It is recommended that equipment be installed with adequate space within and around the equipment, to facilitate adequate cleaning, sanitizing and inspection.
• Equipment design should prevent contamination from the dripping of lubricants from bearings, gears, motors, etc. Should drip pans be necessary for protection against contamination, they should be easily accessible for inspection and for cleaning.
• Processing equipment shall be designed and operated so as to preclude cross connections of any type between raw product and pasteurized product, cleaning solutions and product, and potable water and product.
• Equipment used for thermal processing must meet the requirements set out in the DEIM. Smaller establishments pasteurize product using either a small HTST or a batch pasteurizer. Requirements for equipment are set out in DEIM as follows: Chapter 11 (HTST Pasteurization) and Chapter 12 (Batch Pasteurization). All other equipment used in the dairy establishment must meet the requirements as set out in DEIM (Chapter 16).
• A written Equipment Maintenance and Calibration Program, including Critical Process Test Procedures shall be in place. It is to include procedures, frequencies and records for the maintenance, testing and calibration of all equipment in the establishment. Personnel within the establishment may do the calibrations and equipment testing if they are trained and properly qualified. Otherwise, a reputable equipment calibration/testing company should be hired. The Critical Process Test Procedures in Chapter 18 DEIM (currently under review) must be followed. Records from the third party testing/calibration must be reviewed by the operator and outstanding issues appropriately addressed.

Rationale:

Proper design, installation and maintenance of equipment provides for good sanitation practices and visual inspection. The design and installation of equipment has an impact on the effectiveness of cleaning and sanitizing to protect a dairy product from contamination. Pasteurization has been conclusively shown to prevent diseases which may be transmitted through milk.

Sanitation program

(DEIM 1.10.05.01 and Dairy Products Regulations Section 10. (2)(b))

• The establishment must have on site a complete written sanitation program. The operator must maintain sanitation records and perform effectiveness checks.
• Small establishments may wash and sanitize all equipment by hand (Clean-Out-of-Place). CIP (Clean-in-Place) systems are not necessary if proper cleaning and sanitizing can be accomplished effectively without a CIP system.
• If there is a CIP system it must respect the CIP criteria for time, temperature, concentration and velocity specified by the cleaning specialist.
• Post cleaning sanitizing is required on all equipment (raw product and finished product equipment) in the processing establishment.
• Supervision of the program shall be assigned to individual(s) to assure its implementation and effectiveness.

Rationale:

The implementation of a thorough planned and written sanitation program is essential to ensure product safety by facilitating the continuous effective control of food hazards likely to contaminate dairy products.

Pest control

(DEIM 1.10.05.04)

• An effective pest control program (covering the control of pests both inside and outside the facility) is in place to ensure that the dairy establishment is free of pests, is free of conditions which attract or harbour pests, is protected against the entry of pests, detects any entry of pests, eliminates pests when present in the establishment and removes any sign of pest activity. The program must indicate the measures taken to effectively and safely control insects and rodents and exclude any animals from the registered dairy establishment. The pest control program must include a pest control station map and record keeping.
• All windows and other exterior openings that could allow the entry of insects, birds, bats, etc. are to be equipped with effective screens.
• Air curtains or other acceptable devices are recommended over outside doorways, in areas where screening is not practical such as loading docks. Electronic fly zappers may only be used in areas where food and packaging materials are not exposed.
• There should be no open holes or seams to the outside to prevent entry or habitation by rodents in the dairy establishment.
• Open bait stations are not acceptable inside the establishment. Any chemicals used in pest control must be acceptable for use.
• It is recommended that equipment and supplies be installed at a distance from the walls that will facilitate inspection for the presence of pests.
• Farm pets (cats, dogs, etc.) are not permitted in the dairy establishment.

Rationale:

The implementation of a thoroughly written and adhered to pest control program is essential in order to control pests that are likely to contaminate dairy products in a dairy establishment. Pest control chemicals must be strictly controlled to prevent chemical contamination.

Employee training

(DEIM 1.10.04)

Personnel, including the operator/owner, need to have the necessary knowledge and skills to enable them to process and handle dairy products in a safe and sanitary manner.

• Adequate and suitable training needs to be provided to owners, managers, trainers and all production personnel directly related to the processing of dairy products appropriate for the complexity of the manufacturing process. Training courses may be available on-line or from teaching facilities. An effective training program should consider instruction in the following:
  • basic microbiological training
  • knowledge in general food handling practices
  • hygienic practices including clothing, grooming, health conditions and behaviour and habits
  • handling of materials (ingredients, packaging materials and finished product)
  • pasteurization, reasons for and the microbiological consequences of inadequate pasteurization
  • pasteurization equipment, proper operation, maintenance and testing
  • dairy plant cleaning, equipment cleaning and the sanitary maintenance of the equipment
  • control of post pasteurization contamination including environmental contaminants
  • chemical contamination such as antibiotics, allergens and cleaning chemicals
  • other topics that may be specific to the dairy product being processed

Rationale:

The implementation of an effective and up-to-date training program for dairy establishment workers is critical to ensure that the procedures and practices of these personnel are such that the final product will not be contaminated.

Recall program

(DEIM 1.10.06)

• This program highlights the step-by-step procedures that would be implemented by the operator in the event of a recall. Each unit/package must be coded. Information about the product coding system, including details on how codes are cross-referenced with clients or buyers, and procedures for contacting clients in the event of a recall must be included in the program. This must also cover a coding or tracking system for product sold directly to customers at the establishment. The recall program is to indicate the individuals within the company who are responsible for carrying out recall activities and telephone numbers where they can be reached during off hours.
• The recall program must include a mock recall (testing at a minimum frequency of once per year that demonstrates that the affected product can be traced back to the distribution level).
• All ingredients used (by lot number) should be documented on the manufacturing records.
• The establishment must maintain a complaint file that includes the initial complaint information, investigation of the complaint, a record of the findings and action taken,
• In the case of safety concerns, the establishment must notify the CFIA for consultation if unsure of the need for a recall or to ensure the action/decision taken is correct.

Rationale:

The implementation of an effective recall system is essential to ensure that effective procedures are in place to deal with any food safety hazard and to enable the complete, rapid recall of the implicated lot from the market.

Product and environmental monitoring

(DEIM 1.10.07.01, DEIM 1.10.07.03, DEIM 1.10.07.04 and DEIM 1.10.07.05)

• The dairy products produced in the registered dairy establishment must be sampled and tested to verify compliance to regulatory standards and for product safety (e.g. Salmonella, Listeria monocytogenes, S. aureus, verotoxigenic strains of E.coli) and as an indication of overall sanitation and shelf life (e.g. total coliform, and E. coli, Standard Plate Count, yeast and mold). Product composition (fat and moisture, protein, etc.) must also be verified to regulatory standards.
• The sampling program shall include environmental testing (product contact surfaces and non-product contact surfaces).
• In order to reduce the level of sampling at establishments making small lots of product, but at the same time cover a representative number of different product lots for microbiological monitoring, compositing 5 sub-samples from different lots is acceptable for Listeria monocytogenes and Salmonella (for presence/absence) and compositing 5 sub-samples from the same lot is acceptable for E. coli and S. aureus. If, when compositing from different lots, and results come back out-of- compliance on the composited sample then the 5 sub-samples would have to be re-analyzed individually to ensure compliance to regulations. Individual lots would then each have to have 5 sub-samples analyzed to ensure the safety of each lot.
• The frequency of sampling is to be defined by the establishment and should be determined based on history of compliance, volume of product produced, type of process, consumer complaints, intended use of the product, category of consumers concerned. A newly registered establishment should sample at a higher frequency until a history of compliance is achieved.
• All testing methodologies used are listed in the establishment's written program and include a list of laboratory methods and testing procedures. On-site testing, if performed must be verified by a Standards Council of Canada laboratory (accepted laboratory) at least once per year.
• Following registration, to provide verification that the first products produced are microbiologically safe it is highly recommended that a significant number of finished product lots are tested and held for micro analysis (Salmonella, Listeria, S. aureus and E. coli) prior to product distribution. This is especially critical in the case of raw milk cheese, where it is recommended that the first ten consecutive lots are tested and held.
• When a registered establishment contains a laboratory, the operation of the laboratory must be controlled to make sure it does not pose a risk of contamination to the dairy products.

Rationale:

Sampling and testing of product and environment verifies that the establishment has control over its products and environment and verifies the production of safe food and compliance to regulatory standards.

Product labelling

(DEIM 1.10.07.02, Dairy Products Regulations, Food and Drug Act, Food and Drug Regulations, Consumer Packaging and Labelling Act, Consumer Packaging and Labelling Regulations)

• Products produced must be made from milk which has been pasteurized or treated with an alternative acceptable process which has been approved by the regulatory agency. The only product which may be made from raw milk (or milk treated at a temperature lower than pasteurization) is cheese. Raw milk cheeses must be stored for 60 days prior to sale to the final consumer, unless otherwise authorized by Health Canada and Provinces, where applicable. Raw milk cheeses must be labelled as per requirements for this product as set out in the Food and Drug Regulations.
• All food additives used are permitted for use in a particular food as per Health Canada's List of Permitted Food Additives.
• Label information accurately represents the composition of the products packaged at the establishment.
• Labels accurately reflect product formulation, composition and regulatory requirements.
• Controls are in place to prevent the presence of undeclared allergens.
• The responsibility remains with Industry to ensure that all packaging materials used in an establishment are safe and effective and meet all regulatory requirements.

Rationale:

To ensure that all dairy products meet the same criteria for production and sale; protect dairy products from product misrepresentation and economic fraud; and to be consistent to avoid consumer confusion.

For more information on the CFIA Dairy Program and the registration of dairy establishments, refer to the Dairy Products Regulations (DPR), the complete Dairy Establishment Inspection Manual (DEIM), and other resources on the CFIA's Dairy Products web page.