Dairy Establishment Inspection Manual – Chapter 10 Prerequisite Programs
1.10.01 - Premises Program

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Building and surroundings are designed, constructed and maintained in a manner to prevent conditions which may result in contamination of food.

This documented program as well as its effective implementation will help control operational conditions within an establishment, allowing for environmental conditions that are favourable to the production of safe food. It serves as a prerequisite program or universal-type Critical Control Point (CCP) for a Hazard Analysis Critical Control Point (HACCP) based program.

1.10.01.01 General

Dairy establishments and importers must have a documented program in place to monitor and control all elements in this section, and maintain the appropriate records.

The premises include all elements in the building and building surroundings: building design and construction, product flow, sanitary facilities, water quality, drainage, the outside property, roadways and waste disposal.

Adherence to the criteria is verified by examining the establishment's written program that outlines the procedures that will be undertaken to ensure satisfactory conditions are maintained. The program must specify:

  • areas to be inspected (what is done),
  • tasks to be performed (how it is done),
  • person responsible (who does it),
  • inspection frequencies (how often or when it is done),
  • records to be kept,
  • parameters of acceptability/unacceptability (tolerances),
  • results of monitoring,
  • verification procedures (both on-site and record review) and
  • action to be taken for deviant situations.

The monitoring and verification procedures clearly define the preventative measures taken to prevent the re-occurrence of deviations. The person responsible for verifying the program must be different from the person performing the task. This program must also be updated as required when changes occur.

The actual monitoring of the adequacy of this program will be done by inspecting and assessing tasks 1.10.01.02 to 1.10.01.11.

1.10.01.02 Plant Blueprints and Process Flow

Up-to-date blueprints are a requirement for the registration and licensing of a dairy establishment. The operator must notify the Canadian Food Inspection Agency (CFIA) and responsible provincial authority of any proposed major modification to the registered establishment and submit detailed plans and specifications of the modification. Major modifications that would require the submission of plans and specifications include changes to the boundaries of the registered premises, building additions, changes to the product flow and/or employee traffic flow in the establishment, changes to the air flow, changes to the critical process equipment, changes to the activities and/or products being produced in the establishment.

Blueprints and/or process flow diagrams provide a documentation of the structures in a plant as well as product flow. Refer to Chapter 3.0 Registration (Section 3.5) for list of blueprints required. Blueprints or plant schematics should cover:

  1. Equipment types and location,
  2. Product piping (raw and finished), Clean In Place (CIP), water and other lines that may affect the safety of the product, an up-to-date schematic of floor drains and traps. If the original schematics are not available, new schematics must be created; and
  3. Product flow, i.e. raw materials, packaging, finished product, raw cheese production versus pasteurized cheese production, etc.

Cross connections and cross contamination have been factors in the outbreak of milkborne illnesses in the past. Adequate segregation of incompatible products and activities must be provided by physical means (e.g. separate areas/rooms) or other effective means where cross contamination may result. Examples of incompatible products and activities would include raw milk/pasteurized milk products, raw milk cheese production/pasteurized cheese production. If an establishment produces both pasteurized products and unpasteurized products such as heat treated or raw milk cheeses, pasteurized products must be processed first followed by the raw product or these could be processed on different days. It is also critical that the establishment is designed to avoid contamination between raw product and any product undergoing or having completed maturation or ripening.

All new registrations must have separate rooms for incompatible products. Existing registered establishments must make every effort to separate incompatible products. If a plant is undergoing renovations in the facility then segregation by physical means should also be considered at this time. The type of product being produced would also have to be considered, for example, open cheese vats versus fluid milk plants where product is contained mostly within pipelines. Measures to control cross-contamination risks may include personnel practices (changing clothes, use of foot baths), operational segregation and/or making construction modifications to the plant, with the corrective action dependent upon the type of products and processing equipment used in the plant.

Buildings and facilities must be designed to facilitate hygienic operations by means of a regulated flow in the process from the arrival of the raw material at the premises to the finished product. Living quarters/areas where animals are kept must be separated (complete segregation/separation with no common hallway or entrance way) and not open directly into food handling, processing and packaging areas.

Plant management must ensure that equipment and/or pipelines are not installed in a manner that will jeopardize the integrity of the processing or CIP systems, resulting in cross-connections or processing problems. Plant management must thoroughly review and approve all proposed installations. Minor changes such as pumps or pipelines must also be reviewed and approved. Colour coding of the pipelines on the schematic and use of the envelope method may help to identify cross-connections.

A cross-connection is a direct connection allowing one material to contaminate another. There needs to be a complete segregation of incompatible products such as raw materials and pasteurized or sterilized food products, cleaning products and food products and waste materials or utility materials and food products.

Segregation of incompatible products must be accomplished by the use of separate pipelines and vessels and establishing effective physical breaks at connection points by at least one of the following arrangements: physical disconnecting of pipelines, double block and bleed valve arrangements, double seat valves, aseptic barriers, or other equally effective systems. The installation of segregating valves does not constitute a physical break and is not acceptable, except that a properly designed block and bleed valve arrangement or properly designed aseptic barrier may be used to separate cleaning solutions from food products during CIP or mini-washes.

Plant management and the inspector must follow-up on areas where there appears to be a potential cross-connection. Even if the plant does not have a schematic piping diagram for the plant, an assessment for cross-connections must be made.

Schematics for processing systems will be evaluated under the appropriate task, e.g. for High Temperature Short Time (HTST), 1.11.01, Aseptic Packaging and Processing System (APPS), 1.14.01 and Higher Heat Shorter Time/ Extended Shelf Life (HHST/ESL), 1.17.01.

1.10.01.03 Building Exterior

The building exterior is designed, constructed and maintained to prevent entry of contaminants and pests. Prevention of pest entry and harbourages is an important factor for the exterior structure. The building must not be built in close proximity to any environmental contaminants and industrial activities that are likely to contaminate dairy products within the establishment. Roadways must be maintained to minimize environmental hazards. The surrounding property must be adequately drained.

When evaluating the roof and exterior structure, the elements within this task may contribute to contamination of the plant environment in 3 ways:

  1. provide entry points for pests,
  2. contribute to air borne contamination,
  3. permit leakage of water into plant.

Airborne contamination and leakage of water are the two most important factors with regards to the inspection of the establishment roof. Flat roofs are permissible; however, there must be no accumulation of water. For powder plants, if the air intake supply originates on the roof, and the dryer exhaust stack exits on the roof, powder build-up must be minimized; the roof must be washable.

An establishment with driveway, parking lots and surroundings that are clean and well maintained can give a first impression of good sanitation. When evaluating this task, consider the potential for contamination of the plant interior from:

  1. Dust and soil migrating to the plant interior.
  2. Pests gaining entry to the plant; surrounding trees and shrubs provide food and harbourage for pests.
  3. Storage of equipment, supplies, etc.

1.10.01.04 Building Interior

This task covers all floors, walls, ceilings, stairs and elevators, utility lines and electrical boxes in the establishment. As well, all windows, doors and openings (plastic curtains, hoseport, can inlet and outlet), loading facilities, lighting and ventilation are included.

The building interior is assessed separately for every room in the establishment (exception is item (D) Loading Facilities which is only assessed once). For example, the floors, walls, ceilings, lighting, ventilation, drainage will be rated together for each room in the establishment.

The interior of the plant must be designed to minimize contamination of food, to facilitate sanitary operation and to provide for easy and effective cleaning. To achieve these objectives, attention must be paid to the structural design of the establishment. Facilities must be adequate for maximum production volume.

The interior structures are unlikely to have direct contact with the food produced in the plant. However, accumulations of dust and dirt and condensation may become sources of contamination. It is necessary then to design, construct, finish and maintain these structures in a manner that prevents such conditions. Floors, walls and ceilings are to be constructed of materials that are suitable for the production conditions in the area and are listed in the Reference Listing of Accepted Construction Materials, Packaging Materials, and Non-Food Chemical Products published by CFIA or the manufacturer has a letter of no objection from Health Canada and will not result in the contamination of the environment or food. The reference listing can be consulted for further information.

Older establishments with floors, walls and ceilings which are well maintained and meet the regulatory requirement of a hard finish that is suitable for cleaning, smooth and impervious are not required to renovate or upgrade construction materials to those listed in the Reference Listing of Accepted Constructed Materials, Packaging Materials and Non-Food Chemical Products. As renovations and repairs to the facility are made it is expected that all new construction materials and coatings will be on the list.

Interior structures that do not meet the design criteria outlined on the facing page may be assessed as satisfactory provided that management has an effective program to monitor and clean them. For example ceilings with exposed steel joints and H-beams are not satisfactory in areas where the product is exposed to the atmosphere, except if a program is in place that affirms their good condition through regular cleaning, dusting and inspecting. If no program is in place then modifications or renovations may be required. Another exception to the design criteria outlined on the facing page would be for dry storage areas where less stringent requirements would be acceptable. Existing walls in dry storage areas which exhibit signs of deterioration due to moisture indicate that the construction materials may not be acceptable for that area, and/or ventilation may be inadequate. In these cases even if there is no contamination risk, the materials must be replaced with an approved material that is smooth, hard, and impervious to moisture in order to better facilitate cleaning and withstand working conditions.

A) Floors in processing and receiving areas must be sufficiently sloped to drain to trapped outlets (i.e. ¼ inch per foot or 2%) to enable rapid drainage of liquids. Pooling of liquids must be avoided because they provide a good medium for microbiological growth.

B) Utility lines include all lines for water, steam, electricity, coolants, air and vacuum. The contamination potential of utility lines must be carefully assessed. Colour coding of these lines is recommended to aid in their identification.

C) Where there is a likelihood of breakage of glass windows that could result in the contamination of food, the windows must be constructed of alternative materials or be adequately protected. Where applicable, doors are kept closed and are well sealed to minimize contamination risks (e.g. receiving rooms, boiler rooms, etc.).

D) In the evaluation of the loading area, 2 aspects are important: product integrity and pest control. It is important that the products be protected from exposure to extreme temperature that would have an adverse effect on product integrity. Products can be protected by the use of air curtains, strips of plastic or similar set-ups.

E) The lighting in an establishment must be bright enough for safe food handling and thorough cleaning. Lighting must be appropriate such that the intended production or inspection activity can be effectively conducted; lighting should not alter the food colour. Inspection areas are defined as any point where the food product or container is visually inspected, e.g. Empty container evaluation, product sorting and grading, product evaluation areas in the lab. An establishment must have adequate supplementary lighting (e.g. flashlights) for the inspection of the interiors of bulk tankers or storage tanks. Bulbs and fixtures must be protected to prevent contamination should breakage occur in areas where dairy products and incoming materials are located. All bulbs and fixtures must be clean. Light intensity is to be measured with a light meter at a distance of 75 cm from the floor.

F) This task will also assess if there is a need for ventilation and if the ventilation is adequate. Ventilation assessed in this sub-item is for individual ventilation and heating units within a specific room. The heating, ventilation and air conditioning (HVAC) system will be evaluated under task 1.10.01.10.

The air quality within the room must be examined. Three conditions may apply:

  1. The room may receive air from a central HVAC system,
  2. The room may have its own independent HVAC system,
  3. The ambient air may be the air supply for the room.

In situations (i) & (ii), the installation of an HVAC system or exhaust fans may be required if inferior air quality is evident or there is exposed product. Some rooms require specialized treatment of air. In rooms used for starter manufacture, it may be necessary to maintain the room under positive pressure to eliminate the possibility of airborne contamination.

Ventilation systems are designed and constructed so that air does not flow from contaminated areas to clean areas. Adequate ventilation must be provided to prevent unacceptable accumulations of steam, condensation or dust and to remove contaminated air. Inadequate ventilation may lead to the presence of odours, condensation or mould growth. Direct air movement onto product, product contact surfaces or filling and packaging areas must be avoided (airborne contamination has been suspected as a vehicle allowing pathogens to enter the product).

G) Drains must be trapped and be of adequate size, number and location to prevent the pooling of milk, water or other processing wastes and not pose a contamination risk to dairy products.

Trapped floor drains are essential to prevent possible off odours and contamination of plant air. Drains must be individually trapped; central trapping systems without individual traps are unacceptable because contamination and odours could originate from sewer pipes located between untrapped drains. Bell type traps which are well maintained and in good condition are acceptable. Other acceptable types of traps include U or P types. All new drain construction must have U or P type traps.

Because of the potential to harbour microorganisms, floor drains should be located so that they are readily accessible for cleaning, sanitizing, and inspection. Ideally, floor drains should not be located under or near filling and packaging equipment.

Floors and drains should be constructed and maintained to ensure proper drainage. Brushes used for cleaning floor drains must not be used for any other purpose. Floor drains must be frequently cleaned and periodically flushed with a sanitizing solution. Floor drain covers and baskets should be cleaned and sanitized after each production run. Under no circumstances should high pressure hoses be used to clean drains.

Establishments must be designed and constructed so that there is no cross-connection between the sewage system and any other waste effluent system in the establishment. Effluent or sewage lines must not pass directly over or through production areas unless they do not pose a contamination risk (e.g. properly protected).

In the event that there are cross connections between plant waste and human waste, within the facility, this task must be scored as non-satisfactory. Establishments must have an action plan in place to mitigate the risk of contamination of the product if a problem with the drainage system occurs. The action plan must also include the provision that if an actual problem does occur, that production will not re-start until the drainage system is fixed. Establishments are to be reminded that meeting regulatory requirements is a condition of registration. Establishments operating with drainage problems can be denied registration renewal. It is expected that all new registrations meet the regulatory requirements prior to registration.

The above statements also apply to establishments seeking Food Safety Enhancement Program - Hazard Analysis Critical Control Point (FSEP-HACPP) recognition. Requirements for FSEP-HACPP recognition should be no stricter than what we require in non-FSEP-HACPP establishments. Establishments can be FSEP-HACPP recognized as long as acceptable short and long term action plans are in place.

1.10.01.05 Waste Disposal

Other agencies (e.g. environmental agencies) usually have jurisdiction over sewage disposal. Our concern is that the dairy products are not exposed to contamination risks from the sewage disposal methods.

A) Sewage must be disposed of in a sanitary manner. It is imperative that it not become a source of contamination to the plant environment. Of particular importance is the prevention of odours and pests. For example, open sewage near the plant must not be allowed.

B) Garbage disposal evaluates the handling of wastes from within the plant during operations and the waste collection facilities outside the plant.

It is important that waste be properly disposed of to prevent it from becoming:

  1. an attraction to pests, and
  2. a contribution to air borne bacterial contamination.

Within the plant there must be a sufficient number of garbage containers so that they are accessible to all employees. Plastic bag are permissible but if contamination is a great risk then covered containers are required. These containers must be clearly identified, leak proof, emptied regularly, and cleaned and sanitized prior to use.

If there is a garbage storage room in the plant it must be emptied daily. If odours are a problem then a ventilation system must be installed. The surface of the walls and floors must be cleanable. To facilitate cleaning, the room should be located near a spray hose and also have a nearby drain.

Waste disposal facilities that are located outside of the plant must not attract pests. They must have covers and be kept closed and in good condition. If compactors and bulk garbage units are used, they should be located on a concrete, curbed and drained ramp to facilitate the clean-up of spills. Washing facilities must be nearby.

Combustible wastes should not be burned in the plant vicinity in order to avoid airborne contamination by ash and odours.

C) Whey, if used as a food, can be further processed into products such as lactose, whey powder, whey protein concentrate, etc. and the handling of it as a food will be evaluated under the appropriate processing equipment. This task covers whey when considered as a waste product. Disposal should be by an approved method and must not pollute the environment nor implicate on the sanitary conditions within and outside the establishment.

1.10.01.06 Sanitary Facilities

Careful and frequent hand washing is required in food handling situations to reduce contamination. If a hand washing facility is difficult to find or operate it will not be used. Hand washing facilities in production areas must be of the remote-control type (foot, knee activated or timed). The location, number and the condition of the hand washing facilities is extremely important to the maintenance of good hygienic practices. Evaluations of adequate number and accessibility of handwash stations will be made by the inspector observing the work habits if the employees. These facilities must be provided with liquid or other type of soap dispensers, paper towels in suitable dispensers, and properly constructed and easily maintained receptacles for used towels. In areas where the product is handled directly, hand washing and sanitizing facilities must be provided in a convenient location with trapped waste pipes to drains. It is not acceptable to use equipment and sanitizing facilities as hand dip stations.

Portable facilities and facilities with drainage piping not connected to a drain are not acceptable.

Washrooms must have hot and cold potable running water, soap dispensers, soap, sanitary hand drying equipment or supplies and a cleanable waste receptacle. Washrooms, lunchrooms and change rooms must be provided with appropriate floor drainage, good ventilation and be well maintained in a manner to prevent contamination. Specific attention is required to ensure that pest harbourage and dirt/dust accumulations do not occur. Double doors must separate employee facilities from the processing rooms; these doors are to be self-closing.

1.10.01.07 Essential Signs

Essential signs are required to enforce management policies. No smoking and unauthorized personnel signs are to be posted at outside and inside entrances to the plant and all receiving, processing and storage areas. Hand washing signs are to be posted in washrooms and in all product handling areas. Hazardous material signs are required in areas where cleaners, pesticides, etc. are kept.

The adherence to these management policies is assessed under task 1.10.04.02 - Flow and Practices and task 1.10.04.03 - Hygiene & Health.

1.10.01.08 Non-Processing Areas

This task includes equipment cleaning and sanitizing facilities (e.g. Clean Out of Place - COP) as well as boiler and compressor rooms, retail operations, mechanical shops, etc.

Because there is no exposed product in these areas it is not essential to meet the same sanitary requirements as the food processing areas of the plant. The location of the non-processing area must not pose a risk of contamination to food processing and handling areas. Proper maintenance is required to ensure a sanitary environment.

1.10.01.09 Water/Steam Quality & Supply

This task assesses the quality of the water and steam emanating from the plant's lines and hoses for use in various processing applications. There must be a safe, sanitary and adequate supply of water for use in a dairy establishment at all times. The water supply source must meet the requirements of Health Canada's Guidelines for Canadian Drinking Water Quality. A summary of Canadian Drinking Water Guidelines can be found on Health Canada's website. These guidelines cover microbiological, chemical (e.g. agricultural, heavy metals), physical and radiological contaminants.

The document titled, Canadian Guidelines for Food Processing during Adverse Water Events is also available on Health Canada's website. These guidelines pertain to the safe use of water in the processing of foods during adverse water events. The document is a good reference to assist the industry in minimizing economic impacts of adverse water events.

Typical contaminants that industry should be fully aware of include:

  • Bacterial pathogens - Salmonella, Shigella, Campylobacter, Yersinia, Aeromonas and various strains of Escherichia coli (E. coli).
  • Viral pathogens - Norwalk virus, hepatitis virus and other human enteric viruses.
  • Protozoan parasites - Entamoeba histolytica, Giardia lambia, Cryptosporidium parvum and Cyclospora.
  • Chemical contaminants that could result from environmental contamination or from a chemical spill, incorrect use of pesticides or cross contamination of the water supply with sewage or industrial waste.
  • Cyanobacteria or blue-green algae or pond scum which form in shallow, warm, slow-moving or still water that produce and release cyanobacterial toxins.

A) General

i. Documented Program:

Dairy establishments must have a complete written and fully documented program in place to ensure they are continuously using safe/potable water in the preparation and processing of food. It must monitor for microbiological, chemical (e.g. agricultural) and physical (e.g. heavy metals) contaminants. This program covers all aspects related to water (e.g. water source, in-plant water, reuse water, steam) used in the establishment.

ii. Boil Water Advisory or Water Safety Alert/Drinking Water Avoidance Advisories:

A boil water advisory or a water safety alert may be issued by the local public health unit or other responsible authority, as a result of unacceptable microbiological quality, significant deterioration in the microbiological quality of the source water, significant increase in turbidity (cloudiness) of the source water, chemical contamination, inadequate filtration and/or disinfection during treatment, re-contamination during distribution or as a precautionary measure when there is a concern that microbiological contamination may exist.

Drinking water avoidance advisories may be issued when there is concern about water safety that is not related to microbiological contamination. Examples may include chemical spill into a water source, the inability of existing treatment processes to treat a particular contaminant, cross connection or back flow of a contaminant into the distribution system. Drinking water avoidance advisories are issued when contaminants (e.g. nitrate, copper, cyanobacterial toxins, ethylene glycol) are present at levels considered sufficient to cause acute health effects. These are issued only when there is convincing evidence of a significant public health risk.

Dairy establishments must have an action plan in the event of a boil water advisory/water safety alert/drinking water avoidance advisories. The action plan may include, but is not limited to disinfection, pasteurization of plant water, alternate water source, plant closure. Plant management must also include in the action plan an investigation into the safety of the product produced prior to the advisory.

iii. Communication Strategy:

It is recommended that dairy establishments, where possible, establish a communication strategy with the appropriate municipal, provincial or territorial water authorities for the timely exchange of information in the event of a boil water/water safety alert. It is recognized that there are differences in how this information is communicated, depending on the jurisdiction in which an establishment is located and as such will affect the degree to which an establishment can develop this strategy. Nevertheless it is the responsibility of the plant management to ensure they are continuously using safe/potable water.

B) Water Testing

1) Microbiological Testing:

The microbiological quality of water is determined by testing for the presence of indicator bacteria, such as coliform bacteria. Water must meet Provincial requirements, if these differ and are more stringent than Health Canada's Guidelines for Canadian Drinking Water Quality amended December 2010.

A 100 mL water sample is required for each test, and acceptable test methodology must be used. In Canada three methods are currently used to detect coliform organisms in water (presence-absence (P-A), membrane filter (MF) and multiple tube fermentation (MTF). The methods are described in detail in the most current version of the Standard Methods for the Examination of Water and Wastewater. Refer to Appendix 19 – 12D of Chapter 19 for more information on methods of analysis and procedures for sampling. The water can be analyzed at provincial or municipal public health laboratories, provincially recognized private laboratories or at the establishment's in-house laboratory, but it is critical for accurate results that the water sample size, sampling procedures and acceptable test methodology are followed.

Water is considered microbiologically safe if the maximum acceptable concentration (MAC) for total coliform and E. coli is non-detectable per 100 mL water sample. When using MF or MTF methods results reported as <1 CFU/100mL (for MF method) and <1.8 CFU/100 mL (for MTF method) are considered as meeting these standards,

E. coli is the only coliform bacteria that is considered faecal-specific. Therefore, the presence of E. coli indicates faecal contamination of the water and the possible presence of enteric pathogens, and a boil water advisory should be issued by the local public health unit or responsible agency.

The presence of total coliforms, in the absence of E. coli does not necessarily require the issuance of a boil water advisory but corrective actions need to be taken. The operator must re-sample and test any sites that are positive for coliforms.

If E. coli is confirmed, immediate re-sampling of the positive site is required, the appropriate agencies should be notified, and if applicable, a boil water advisory should be issued by the local public health unit or responsible agency and corrective actions taken. An evaluation of any product will also have to occur

Refer to Appendix 19 - 12D for more information on corrective action and follow-up procedures for unsatisfactory results. The corrective action and follow-up will vary depending on whether the contamination was found in the source water sample or the in-plant water samples or if the source water is municipal water or private well water.

i. Source Water:

The water entering the establishment meets the requirements of the official government body having jurisdiction. The quality of the water supply must be analyzed at least once per year to confirm its microbiological quality. If the source of the water is a private well then the manufacturer is responsible to have the water analyzed. If the source of the water is from the municipality and the analysis is carried out by the municipality, then the manufacturer can obtain the analysis from the municipal agency. In either case the record of the analyses must be on file at the establishment.

ii. In Plant Water:

The quality of product contact water must be tested once per month. Such analyses will determine if the plant's water lines and filters are sanitary and effective. Product contact water is defined as ingredient water, water used for flushing product, and water used for washing and sanitizing purposes. A record of the analyses must be maintained by the plant. Suitable sites for sampling include a drinking water tap and a point of use, such as a hose. Sampling sites should be representative of different areas throughout the plant, although not necessarily the same points at each occasion. Over time, the sample sites should cover all applicable areas of the plant.

2) Chemical Testing:

Chemical analysis of the source water must be provided by the operator prior to establishment registration. The range of chemical analysis will depend on local conditions, such as geological formation, seepage from soil treated with fertilizers, pesticides or local exposure to industrial pollution. To establish the range of tests and when to test, Provincial Environmental authorities should be consulted. The guidelines for chemical parameters can be found on the Health Canada website. Health Canada recommends chemical testing the source twice a year.

If the source of the water is a private well the analysis must be undertaken by the manufacturer. Subsequent testing, once an establishment is registered may be required if there is any change to the well or piping system of a private well. If the source of the water is the municipality and the chemical analysis is carried out by the municipality, the manufacturer can obtain a copy of the analysis from the municipal agency. In either case the record of analyses must be on file at the establishment.

C) Operation

i. Water Filtration

Water used as a food ingredient or for flushing product must be filtered to remove hazardous extraneous material to a particle size of 2mm. Water used for CIP purposes must be free of rust, excessive scale and other foreign material. This may be done by filtering it.

Water could be filtered at the supply end or it could be filtered by a central filtration system. Wherever the location of the filter, it is important that all pipelines downstream from the filter are made of a material that does not contribute the addition of extraneous material to the water e.g. corrosion free (not rusting, not flaking).

ii. Design

Water that is used solely for fire protection, boilers or auxiliary services (e.g. cooling of compressor heads) does not have to meet the same criteria for potability. However, it is mandatory that there be no possibility of cross connections between the potable and non-potable systems, i.e. must be a closed system. A cross-connection, in the context of potable water, means any actual or potential connection between a potable water system and any source of pollution or contamination (Note: Bypass arrangements, jumper connections, removable sections, swivel or changeover devices, or any other temporary or permanent connecting arrangements through which backflow can occur are considered cross-connections.)

When water is used for cooling in the heat exchanger it must be potable.

Non-potable water may be used in an evaporator for condensing providing there are no restrictions (such as pumps) on the condensation line. Colour coding of non potable water lines is recommended.

Plant management must ensure that equipment and/or pipelines are designed and installed in a manner that will not jeopardize the safety of potable water used in dairy establishments. Therefore, plant management must ensure adherence to the requirements outlined under Appendix 19 - 12C with regard to the potential and actual risks associated with backflow as well as the use of appropriate backflow prevention devices.

Throughout the course of the in-depth inspection, particular attention must be paid to areas and processes in the establishment that have the potential to pose risks of backflow. These areas and processes include, but are not limited to:

  • CIP and COP systems
  • Water used for flushing product or chemical
  • Raw receiving, rinsing tankers, silos
  • Reclaimed water (cow water) from evaporators or membrane filters
  • Boiler rooms and boiler water feed
  • Cooling towers, plate heat exchangers using potable water, chilled water tanks and glycol supply systems
  • Process water used for reconstitution or water for brining, etc.
  • Fire protection water systems
  • Other equipment using potable water such as fillers, homogenizers, separators

Devices used for prevention of backflow as per Section 6.0, Appendix 19 - 12C, require periodic testing at an appropriate frequency determined by the establishment or as per manufacturer's recommendations to verify that they are operational.

Where it is necessary to store water, storage facilities are designed, constructed and maintained to prevent contamination, e.g. covered, properly constructed of material(s) that will not contaminate the water and should allow for periodic cleaning and sanitizing. For example, these could be approved materials from the Canadian Water and Wastewater Association (CWWA) or materials for such use as per manufacturer's guidelines. Without proper design, operation, and maintenance of these facilities, stored water may easily become stagnant and subject to loss of chlorine residual, as well as bacterial re-growth, contaminant entry, and a host of other water quality problems.

iii. Water Treatment

If the source of the water poses a contamination risk it may be necessary to treat the water. The water treatment method used will depend on the reason for treating the water, e.g. microbiological, protozoan, viruses, chemical. Some water treatment devices are described in Appendix 19 - 12A.

Water treatment chemicals, where used, are listed in the Reference Listing of Accepted Construction Materials, Packaging Materials and Non-Food Chemical Products published by CFIA or the manufacturer has a letter of no objection from Health Canada.

The method of disinfection chosen by the operator must result in water that does not present a microbiological or chemical risk. Chlorine may be used as a disinfectant for well water supplies. The dose is dependant on the water flow rate, pH, temperature and chemical composition. Automatic dosing can be done by the use of a metering device. Where automatic chlorinators are used, it is essential that the establishment establish procedures to ensure water potability. Two controls which are fundamental when using automatic chlorinators are as follows:

  1. A metering device for adding chlorine in the correct concentration, relative to the water flow rate, designed to readily indicate malfunction and
  2. Such systems must be monitored and controlled twice daily. Tests shall be made to determine available chlorine level at a specific point, remotely located from the chlorine application site, but before distribution to the plant system. The establishment should have the appropriate test kit on hand (titration method) to determine available chlorine.

An automatic analyzer equipped with a recorder and an alarm, to ensure water potability, desired concentration and to prevent contamination may be utilized as an alternative to the above testing.

Where water is in direct contact with finished product, as is the case with washing cheese curds or when water is added unintentionally when flushing product post-pasteurization it is recommended that the operator considers installing an in-plant disinfection system for food application for those areas of the establishment. This water disinfection system should be handled like a critical control point including measurable tolerances for acceptability/unacceptability, monitoring and verification procedures and an action plan in the event of a failure to the system.

D) Water Reuse

Reuse water is water that has been recovered from a processing step, including from the food components, and that after subsequent reconditioning treatment(s), as necessary, is intended to be re(used) in the same, prior, or subsequent food processing operation.

The type of reconditioning to reduce or eliminate microbiological, chemical and physical contaminants will depend on the intended use of the water. Reuse water should not jeopardize the safety or suitability of the product. The source of the water and/or the prior collection and the intended reuse of the water dictate the degree of reconditioning and frequency of monitoring that is necessary. Reuse water intended for incorporation into a food product, used for flushing product or for washing and sanitizing purposes must meet the microbiological and chemical specifications for potable water.

The two types of reuse water identified for use in a dairy establishment are as follows:

i. Re-circulated water:

Re-circulated water is defined as water re-used in a closed loop for the same processing operation. Re-circulated water must be treated, monitored and maintained as appropriate for the intended purpose. Re-circulated water must have a separate distribution system which is clearly identified.

ii. Reclaimed water:

Reclaimed water is defined as water that was originally a constituent of a food, has been removed from a food by a process step, and that is intended to be subsequently re-used in a food processing operation. Condensed water from milk evaporators and water reclaimed from milk and milk products, also referred to as cow water, may be re-used within the establishment, thereby conserving water resources. Where water is reclaimed it is important to ensure the water is safe and suitable for its intended purpose. This water may be treated and must be monitored and maintained as appropriate for the intended use within the establishment. Refer to Appendix 19 - 12B for specific requirements on this task.

E) Steam Supply

The operation of the boiler and the quality of the steam it produces are evaluated here. Within an establishment steam is used for cleaning, sanitizing and as part of the manufacturing processes. If it has direct contact with the product and product contact surfaces it must be culinary type steam.

i. Water/Steam:

The water from which the steam is generated may be a food ingredient and thus must meet all the regulatory requirements for potable water. Of particular risk are the corrosion inhibitors and water conditioning compounds that are used in the boiler.

Control of boiler operations, in particular the boiler feed water treatment, must be under the supervision of trained personnel or a firm specializing in industrial water conditioning. Boiler feed water must be tested regularly and the chemical treatment controlled to prevent contamination.

If the steam/hot water is in direct contact with product and/or the steam/hot water is used to sanitize product contact surfaces and is not followed by a potable water rinse then boiler treatment chemicals used must be listed in the Reference Listing of Accepted Construction Materials, Packaging Materials, and Non-Food Chemical Products published by CFIA or the manufacturer has a letter of no objection from Health Canada. In this case it is important that the operator of a dairy plant read the label of all water additives and consult with the manufacturer to assure that the water additives do not contain the following chemicals:

  • 2-Amino-2-methyl-1-propanol
  • Cyclohexylamine
  • Diethylaminoethanol
  • Morpholine
  • Octadecylamine
  • N,N-Bis (2-hydroxyethyl) Alkyl (C 12-C 18) amine derived from coconut oil
  • Trisodium nitrilotriacetate

The prohibition of boiler water additives that contain amines is to eliminate the risk of forming nitrosamines in the dairy products.

ii. Culinary Steam

Culinary steam must meet certain standards because it is used in direct contact with milk and dairy products. Refer to Appendix 19 - 1 for further information on this task.

Direct steam injection that requires culinary steam is used in the following processes and products:

  • Manufacture of ricotta and cottage type cheeses.
  • Preheating of milk for production of evaporated milk, sweetened condensed milk and non-fat dry milk.
  • Vacreation and pasteurization of milk and creams.
  • Heating of water used in production of for example, butter oil and mozzarella cheese.
  • Process cheese cooking.
  • APPS processing.

It is recommended to periodically analyze steam condensate samples. Carry over of boiler water additives can result in the production of off flavours. Samples should be secured from the line between the final steam-separating equipment and the point of the introduction of steam into the product.

F) Water and Steam Hose Equipment

Poorly maintained hoses may contribute to the contamination of the water supply. Inspecting the condition of the hose equipment (nozzles, ends and exterior) is done to determine if it is maintained in a sanitary manner and is in good repair. Hoses are stored off the floor.

G) Records

The manufacturer has written records available to demonstrate the adequacy of the microbiological and chemical safety of the water and steam supply. The records include municipal and/or establishment's own water testing records for microbiological and chemical testing; water potability testing (water source, sample sites (including date and time sample taken), analytical results, analyst, date); water treatment records (method of treatment, sample site (including date and time sample taken), analytical results, analyst, date); water reuse records (for re-circulated and reclaimed water). The records specify the person who is responsible, analyses and results, parameters of acceptability/unacceptability (tolerances), frequency and results of monitoring and verification, satisfactory follow-up for out of specification findings and is updated as required.

1.10.01.010 HVAC (heating, ventilation, air conditioning) System Unit

This task assesses the HVAC system unit only. Individual ventilation units are evaluated separately under task 1.10.01.04 - Building Interior, in specific rooms.

Since air from the HVAC system unit is supplied to various parts of the establishment by ducts, it is important that this air supply not be a source of contamination. Pathogenic organisms can enter the product via a contaminated air source.

This unit is usually located on the roof or in a special room. Temperature is controlled by placing heating and/or cooling elements within the ducts. Filters are used to remove extraneous matter.

HVAC systems must be cleanable and maintained clean. Special attention to the condensate drip pans and drain line is required to minimize potential growth of pathogens. Air intakes should not be located near unfavourable activities (e.g. feed mills, livestock operations).

1.10.01.011 Glass Breakage Policy

This task will cover the policy required if an establishment handles glass containers or has glass or glass substitutes (e.g. plexi-glass) present in manufacturing areas, e.g. glass windows, UV lights, glass doors, in-line pH meters etc. The use of glass in processing areas should be discouraged. Where glass does exist it is recommended to be of the shatterproof type, where applicable. The receipt, acceptance and storage of glass is rated under task 1.10.02.03 Incoming Material.

The plant must have a documented glass breakage policy if it meets the above mentioned conditions, to assess if it will control the risk of glass contamination should breakage occur. Some guidelines that could be included in this policy are:

  1. The line or processing area must immediately shut down.
  2. Broken glass containers and/or loose glass fragments must be removed from the area.
  3. Clean-up procedures are to be outlined (they must not spread the contamination).
  4. The line (filler, capper) and/or area must be inspected to ensure that clean-up was adequate.
  5. The breakage and the type (thermal shock, impact etc.) must be recorded.
  6. Excessive breakage is to be investigated.

The records must be examined to determine if breakage did occur and if it was well handled and documented. The date, time and location of glass breakage, the type of breakage (e.g. thermal shock/impact), the extent of potential contamination (filler bowl, capper, hopper) and the results of the investigation must be recorded.

Premises Program Summary Table
HS = Health and Safety Rating
Table description

This table shows the tasks, ratings and inspection criteria for premises program general, plant blueprints and process flow, building exterior, building interior and waste disposal, sanitary facilities, essential signs and non processing areas, water/steam quality and supply, heating, ventilation and air conditioning (HVAC) system unit and glass breakage policy

Task Inspection Criteria
1.10.01.01 General (HS=3) (A) Documented Program
  • Covers the outside property, roadways, drainage, building design and construction, product flow, sanitary facilities and water quality
  • Specifies the procedures to ensure maintenance of satisfactory conditions
  • Specifies areas to be inspected, tasks to be performed, person responsible, inspection frequencies
  • Specifies preventative measures to prevent the re-occurrence of deviations
  • Specifies parameters of acceptability/tolerances
  • Updated as required

(B) Records

A representative sampling of the plant's historical records must be assessed.

  1. Records must be:
    • Accessible and complete
    • Clear, legible and permanent
  2. Information must indicate:
    • All premises records
    • Frequency and results of monitoring and verification
    • Satisfactory follow-up when deviations found and documentation of actions taken
1.10.01.02 Plant Blueprints and Process Flow (HS=3) (A) Plant Blueprints and/or Process Flow Diagram
  • Available
  • Contacted Canadian Food Inspection Agency (CFIA) or responsible provincial authority of proposed major modifications, as required
  • Verified regularly by management
    • changes reviewed and approved
    • no cross-connections or contamination risks

(B) Process Flow Separation

  • New registrations have separate rooms for incompatible products
  • Adequate segregation of activities
  • Control measures being used to reduce contamination risks
  • Regulated process flow
    • from raw material receiving to finished product shipping
    • no contamination risk
    • pasteurized cheese production occurs prior to heat treated or raw cheese production or are processed on separate days
  • Proper segregation of incompatible products
    • separate vessels and pipelines
    • physical breaks at connections
    • separate areas/rooms (raw milk from pasteurized products; raw cheese from pasteurized cheese)
    • no contact between raw product and product undergoing maturation or ripening
  • If washes or mini-washes while connected to product double block & bleed valve arrangement, aseptic barrier for Aseptic Processing and Packaging Systems (APPS)
1.10.01.03 Building Exterior (HS=4) (A) Roof
  • Drainage
    • Proper slope with no accumulation of water
    • Drain spouts at ground level directed away from building
  • Surface
    • Free of leaks, cracks, openings
    • Cleanable type for powder plants
    • Clean, free of trash and vegetation

(B) Exterior Walls and Trim

  • Sound
    • No openings, cracks
  • Eavestrough and trim
    • No pest/bird harbourages

(C) Driveway and Parking Lots

  • Properly graded, compacted, and well drained
  • Surfaced with dust free material

(D) Surroundings

  • Free of uncontrolled vegetation and stored items in close proximity to the establishment
  • Building is not built near environmental contaminants or industrial activities that could pose a threat of contaminating dairy products
1.10.01.04 Building Interior (more to follow) (HS=3) (A) Floors, walls, ceilings, stairs and elevators
  • Reference listing can be found on the CFIA website.
  1. Design
    • Hard
    • Smooth
    • Impervious to moisture (exception: dry storage areas)
    • Free of pitting, indentations, cracks, crevices and ledges
    • Well joined or coved and, in the case of floors:
    • Sloped
  2. Clean and in good condition
    • Free from mold growth
    • Free from flaking material
  3. Specific Areas of Interest
    • Hoseport
    • Can inlet and outlet

(B) Utility Lines

  • Clean
  • Identified
  • Suspended away from work areas
  • Free of flaking material
  • No leaking
    • insulated to prevent condensation, where appropriate

(C) Doors & Windows

  • Sealed or close fitting screens
  • Tight fitting, self-closing; non-absorbent surfaces
  • Glass windows protected against breakage in critical areas

(D) Loading Facilities

  • Docks clean and in good condition
    • well lit
    • smooth and slightly sloped
    • free of cracks and crevices
  • Proper temperature control
    • appropriate use of air curtains

(E) Lighting

  1. Light bulbs, tubes or glass fixtures
    • Shatterproof
    • Clean
  2. Intensity
    • Minimum illumination at the working area
      • 540 lux (50 foot candles) in grading and inspection areas, product inspection areas in the lab
      • 220 lux (20 foot candles) in the general processing e.g. filling, and equipment cleaning areas (or work areas)
      • 110 lux (10 foot candles) in other areas

(F) Ventilation

  1. General
    • Air intakes outlets
      • General conditions
        • filtered
        • clean
        • well located; minimize air contamination
        • outlets not directly over product or sensitive area
      • Filters
        • clean
        • regularly monitored
    • Exhaust fans
      • Screened and/or self-closing louvres
      • Clean
    • Air treatment methods (where required)
      • Positive pressure
  2. Operation
    • Air quality
    • Adequate ventilation
      • no mould growth
      • no condensation on walls, ceilings or equipment
      • no persistent strong odours

(G) Drains

  1. Design
    • Adequate size
    • Individually trapped
    • No cross contamination from sewer lines or other parts of system
      • no cross-connection between sewage system and any other waste effluent in establishment; action plans in place to mitigate the risk of contamination if there are cross-connections (see text section for more details)
      • Sewage lines do not pose a contamination risk if located directly over or through production areas
    • Covered with removable covers
    • Interior surfaces of trench drains smooth and easy to clean
  2. Location
    • Readily accessible for inspection and cleaning
    • No contamination risk to dairy products
  3. Maintenance
    • Clean and sanitized
    • Odourless
    • Included as item in sanitation program
      • not cleaned by high pressure hoses
1.10.01.05 Waste Disposal (HS=4) (A) Sewage Disposal
  • No contamination potential
    • no pests
    • no odours
    • isolated from plant if independent treatment

(B) Garbage Disposal

  1. Inside the plant
    • Containers
      • sufficient in number, clearly identified and leak proof
      • covered if contamination risk
      • regularly emptied, cleaned and sanitized
    • Garbage Storage Room
      • emptied daily
      • no odours
      • clean
  2. Outside the plant
    • Compactors and Bulk Garbage Units
      • covers in place
      • sloped and drained, concrete ramp or platform
      • adequate disposal frequency
  3. Incinerators
    • sufficient distance from plant

(C) Whey Disposal & Handling (as waste product)

  • Storage tank - Loading area
    • on concrete platform; washable
    • well drained; sloped, suitable drains
    • clean surroundings
    • free of flies, insects and objectionable odours
  • Added to sewage treatment system
    • written confirmation from appropriate government agency
  • Operation
    • handling technique
1.10.01.06 Sanitary Facilities (HS=3) (A) Hand Washing/Sanitizing Facilities
  • Location
    • convenient & accessible
    • close to product handling areas
  • Adequate number
  • Components of facilities
    • remote-control type (foot, knee or timed) in production areas
    • hot & cold potable water
    • germicidal soap
    • sanitary hand drying supplies or device
    • cleanable waste receptacle
  • Condition
    • clean and in good repair
    • trapped waste pipes to drain
  • Hand sanitizing facilities
    • available in areas where personnel are in direct contact with product

(B) Employee Facilities (washrooms, lunchrooms, change rooms)

  • Separated from food handling areas
    • pose no contamination risk
    • no direct opening to processing rooms; self closing doors
  • Well ventilated
  • Appropriate floor drainage
  • Well maintained
  • Washrooms have adequate hand washing facilities
1.10.01.07 Essential Signs (HS=4) (A) Appropriate Signs
  • No smoking
  • Unauthorized personnel
  • Hand washing
  • Hazardous materials

(B) General

  • Adequate number
  • Visible
  • Posted in appropriate locations
1.10.01.08 Non Processing Areas (HS=4) (A) Equipment Cleaning and Sanitizing Facilities (e.g. Clean Out of Place (COP))
  • Facilities constructed of corrosion resistant materials
    • easily cleaned
    • potable water, at adequate temperatures for chemical usage
    • temperature, time and chemical concentration monitored (either manually recorded or with a recording chart). Frequency of validation of COP cleaning is determined by the establishment and acceptable to CFIA inspector
    • adequately separated from food storage, processing and packaging areas; pose no contamination risk

(B) Other Rooms (boiler, compressor and mechanical rooms, retail operations)

  • Separated from food handling areas
    • pose no contamination risk
  • Properly maintained
  • Free of pest harbourages
  • Meets minimum building interior criteria (1.10.01.04)
1.10.01.09 Water/Steam Quality & Supply (more to follow) (HS=2) (A) General - Water Quality
  1. Documented Program
    • Monitors and controls the water (source, in-plant, re-use) and steam quality on an ongoing basis
    • Monitors for microbiological, chemical and physical contaminants
  2. Action plan in the event of a boil water advisory/water safety alert/drinking water avoidance advisory
    • Includes investigation into the safety of prior products produced
  3. Communication strategy with appropriate water authorities is recommended
    • Depending on jurisdiction

(B) Water Testing

  1. Source Water
    • Supplied either by the municipality or private well
    • Meets requirements of official government body having jurisdiction
    • Tested annually (micro) using acceptable sample size, sampling procedure, test methodology. Refer to Appendix 19 -12D.
      • Maximum acceptable concentration for both total coliform and E. coli is non-detectable per 100 mL sample. Results reported as <1 colony-forming unit (CFU)/100mL (for membrane filter (MF) method) and <1.8 CFU/100mL (for multiple tube fermentation (MTF) method) are considered as meeting standards
      • corrective action taken for unsatisfactory results
    • Chemical analysis maintained on file at time of registration; subsequent testing completed as needed
    • Records of quality on file
  2. In Plant Water
    • Product contact water (e.g. ingredient water, water for flushing product, water for washing and sanitizing purposes)
      • Tested once per month (micro) using acceptable sample size, sampling procedure, test methodology. Refer to Appendix 19 –12D.
      • Maximum acceptable concentration for both total coliform and E. coli is non-detectable per 100 mL sample.
      • Results reported as <1 CFU/100mL (for MF method) and <1.8 CFU/100mL (for MTF method) are considered as meeting standards.
      • Site selection is representative of areas in plant
      • Corrective action taken for unsatisfactory results. See Appendix 19 – 12D
    • Records of quality on file

(C) Operation

  1. Water Filtration
    • Water when used as an ingredient or for flushing product is filtered to remove hazardous extraneous material to a particle size of 2mm
    • Water used for clean in place (CIP) purposes is free of rust, excessive scale and other foreign material.
    • Filter location: supply end or central filtration system
      • pipelines downstream from the filter are made of a material that does not cause addition of hazardous extraneous material e.g. not rusting, not flaking (corrosion free)
  2. Design
    • No cross connections between potable and non-potable water systems (see Appendix 19-10)
    • Equipment and/or pipelines are designed and installed so that they do not jeopardize the safety of potable water
      • requirements of Appendix 19 - 12C are being met with regards to potential and actual risks regarding backflow
      • devices used for backflow prevention are tested at an appropriate frequency to verify that they are operational
    • If water is used for cooling in the heat exchanger it is potable
    • Water storage facilities prevent contamination of the water and allow for periodic cleaning and sanitizing
      • Canadian Water and Wastewater Association (CWWA) approved materials or as per manufacturer's guidelines
  3. Water Treatment
    • May be treated to ensure potability
    • Disinfection method used is effective for intended purpose (see Appendix 19 - 12A)
      • method does not pose microbiological or chemical risk
    • Water treatment chemicals, where used, are acceptable
    • Disinfection method poses no risk
      • If automatic chlorinators used, the concentration of available chlorine is monitored and controlled twice daily

(D) Reuse Water

  • Type and degree of reconditioning is effective for intended use of the water
  • Does not jeopardize the safety or suitability of the product
  • Frequency of monitoring is sufficient for intended purpose
  1. Re-circulated water (if required)
    • If used, is treated, monitored and has a separate, identified distribution system
  2. Reclaimed water
    • Meets the requirements of Appendix 19 – 12

(E) Steam Supply

  1. Water/Steam
    • Potable water used
    • Acceptable boiler water additives required for dairies
      • if steam in direct contact with product
      • if steam used to sanitize product contact surfaces and not followed by potable water rinse
    • Traps are provided to ensure
      • adequate condensate removal
      • elimination of foreign materials
  2. Culinary Steam
    • Complete, correct piping assemblies
    • Production supervised by trained personnel
    • Meets requirements of Appendix 19 – 1

(F) Water and Steam Hose Equipment

  • Pose no contamination risk
  • nozzles, ends and exterior: clean and in good condition
  • stored off floor

(G) Records

  1. Records must be:
    • Accessible and complete
  2. Records must include:
    • Person responsible
    • Municipal water testing records (including chemical analysis)
    • Chemical analyses and results on well water
    • Water potability records (water source, sample site (date and time sample taken), analytical results, analyst, date)
    • Water treatment records (method of treatment, sample site (date and time sample taken), analytical results, analyst, date)
    • Reuse water records (re-circulated or reclaimed water)
    • Analyses and results indicated
    • Frequency and results of monitoring and verification
    • Satisfactory follow-up for out of specification findings
    • Updated as required
1.10.01.10 HVAC System Unit (heating, ventilation, and air conditioning system)(HS=3) (A) Specific Areas of Interest
  • Air intakes
    • filtered
    • clean
    • well located
  • Filters
    • clean
    • regularly inspected
  • Fans
    • screened or self-closing louvers
    • clean
  • Drip pans, drain lines
    • properly maintained

(B) Records

  • HVAC unit
    • maintenance records to be kept
    • available; easily accessible
    • complete
1.10.01.11 Glass Breakage Policy HS=3) (A) Documented Program
  • Covers all glass areas
  • Covers glass substitutes (e.g. plexi-glass)
  • Specifies procedures to be followed
  • Designates responsible personnel
  • Updated as required

(B) Records

  • Available; easily accessible
  • Complete
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