A grade B dairy plant that is a qualified facility shall comply with the requirements of 21 CFR Subparts B and F, and 21 CFR 117.201
A grade B dairy plant that is a facility shall comply with the requirements of 21 CFR Subparts B, C, F, and G.
ATCP 65.23 History
History: CR 14-073
: cr. Register August 2016 No. 728
, eff. 9-1-16; correction in (1) (a), (2) (a) made under s. 35.17
, Stats., Register August 2016 No. 728
ATCP 65.24 Construction and maintenance. ATCP 65.24(1)(a)(a)
Buildings, facilities, and equipment used in the operation of a dairy plant shall be soundly constructed and shall be capable of being maintained in a clean and sanitary condition. The interior and exterior portions of a dairy plant and the premises on which a dairy plant is located shall be kept free of unhealthful and unsanitary conditions and shall be maintained in compliance with this chapter.
The division may issue a written waiver granting a variance from a construction standard under this subchapter if the division finds that the variance is reasonable and necessary under the circumstances, and will not compromise the purpose served by the construction standard and the facility does not hold a grade A permit. A waiver under this paragraph may be issued by the administrator of the division or the administrator's designee.
After the effective date of this chapter, a dairy plant may not be directly connected to a milking barn, milking parlor or animal housing area. A dairy plant may be separated from a milking barn, milking parlor or animal housing area by a room not used for animal husbandry or milking, provided doors between the dairy plant, the room not used for animal husbandry or milking, and the milking barn, milking parlor, or animal housing area are self-closing and kept closed when not in use.
The floors of all rooms in which dairy products are processed, handled, or stored or in which dairy product containers, equipment, or utensils are cleaned and sanitized shall be all of the following:
Constructed of concrete or equally impervious and easily cleanable materials. This paragraph does not prohibit tightly joined wooden floors in storage rooms used solely for the storage of dry ingredients or packaging materials, or both.
Sloped to provide adequate drainage. This paragraph does not apply to floors in storage rooms used solely for the storage of dry ingredients or packaging materials, or both.
Equipped with an adequate number of trapped floor drains, so that any liquids draining onto the floors are promptly removed. Floors in refrigerated storage rooms need not have floor drains if the floors are sloped to drain to one or more exits to prevent pooling of liquids. This paragraph does not apply to floors in storage rooms used solely for the storage of dry ingredients or packaging materials, or both.
Walls and ceilings of rooms in which dairy products are handled, processed, or stored, or in which dairy product containers, equipment, or utensils are cleaned and sanitized, shall have a smooth, washable, and light-colored surface, and shall be kept clean and in good repair. Suspended ceiling panels are prohibited in any room where powdered dairy products are packaged or processed if that room was constructed or substantially altered after December 1, 1994.
ATCP 65.24 Note
Note: Walls and ceilings may consist, for example of smooth finished concrete construction panels or cement plaster.
If condensation may accumulate on overhead pipes, ducts, or other fixtures, those fixtures shall be arranged or shielded so that condensation does not drop into dairy products or ingredients, or onto product contact surfaces of equipment, utensils, or packaging materials.
In rooms constructed or substantially altered after the effective date of this chapter, the junctions of walls and floors in processing areas shall be coved to facilitate cleaning.
Doors, conveyor openings, and other openings to the outside environment shall be kept closed when not in use, and shall at all times be protected against the entry of insects, rodents, and excessive dust. Doors to the outside, other than overhead doors and electronic sliding doors in delivery areas of milk receiving stations and grade B dairy plants, and emergency exit doors routinely used by dairy plant personnel shall be self-closing. External screen doors, if any, shall open outward.
ATCP 65.24 Note
Note: Air curtains, strip curtains, and similar devices may be used to prevent insects and excessive dust from entering through doors and other openings while those openings are in use.
Windows, if not permanently closed, shall be screened against flying insects, rodents, and birds. In dairy plants constructed or substantially altered after the effective date of this chapter, window ledges shall be sloped to an angle of at least 45º below horizontal to facilitate cleaning.
Outside openings of dairy product pipelines shall be tightly capped when not in use. When a pipeline is in use, the pipeline cap shall be tethered or placed on a sanitary hanger or rack to protect it from contamination. Pipeline openings through walls shall be completely cemented or fitted with tight metal collars.
At each doorway leading from a non-processing area to a processing area in which exposed dairy products are processed, a dairy plant operator shall provide a sanitizing footbath, disposable footwear, dedicated footwear, or other facilities to ensure that footwear worn in the processing area is clean and sanitary.
Lighting in every area of a dairy plant shall be fully adequate for the purpose for which the area is used. Except as provided under par. (b)
, there shall be at least 5 foot candles (54 lux) of illumination, measured at 30 inches above the floor, in every part of a dairy plant.
Except as provided under par. (c)
, there shall be at least 30 foot candles (323 lux) of illumination at every place where dairy products are processed and at every place where equipment or utensils are cleaned and sanitized.
There shall be at least 50 foot-candles (538 lux) of illumination on every surface where dairy products are graded or examined for condition and quality, and on every surface where multi-use packages are inspected before being reused.
Light bulbs, fluorescent light tubes, skylights, and other overhead glass fixtures shall be shielded to prevent broken glass from falling into dairy products or onto dairy product contact surfaces.
Every room in a dairy plant shall be adequately ventilated and adequately controlled for temperature and humidity to keep the room reasonably free of fumes, odors, mildew, and excessive condensation.
Ventilation systems, including exhaust fans, intake fans, and ventilation ducts, shall be kept clean and in good repair and shall be screened or louvered to prevent contamination of dairy products, ingredients, equipment, utensils, or packaging materials by dust, insects, or other contaminants. Intake fans shall be equipped with filters that are readily removable for cleaning and replacement. Air intake filters shall be capable of removing at least 85% of particulate matter that is 5 microns or larger in size.
Ventilation systems in a dairy plant shall be positioned so that exhaust air does not contaminate exposed dairy products, clean dairy product packages, or clean equipment or utensils.
Dairy plant rooms shall be large enough so that activities conducted in those rooms can be conducted in a safe and sanitary manner.
Within a dairy plant, all of the following areas shall be located in separate rooms:
Areas used to clean and sanitize bulk milk tankers or bulk transport containers. Bulk milk tankers and bulk transport containers may be cleaned and sanitized in the same room where they are unloaded.
Areas used to clean or sanitize dairy product packages or containers.
Areas used to store or fabricate dairy product packages. Packaging materials required for each day's processing operations may be kept in a processing area on that day.
Areas used to store dairy product ingredients, other than raw milk. Ingredients required for each day's processing operations may be kept in the processing area on that day.
Areas used to receive, handle, or store returned packaged dairy products.
Areas used for boiler, heating plant, utility, or maintenance equipment.
Areas, if any, used as living quarters. Processing or storage rooms that are constructed after the effective date of this chapter, and share one or more walls with adjacent living or sleeping quarters, shall have a separate entrance and shall not provide direct access to the living or sleeping quarters.
In dairy plants constructed or licensed after December 1, 1994, raw milk shall be unloaded in a fully enclosed intake room.
Notwithstanding par. (b)
, a dairy plant operator may store, cool, separate, and clarify raw milk in an area that the operator uses to unload bulk milk shipments if all the following apply:
Containers used to store, cool, separate, and clarify the raw milk are filtered or vented to a separate room to protect the milk from airborne contamination in the unloading area. If containers are vented to a separate room, that room shall comply with processing area sanitation standards under this chapter.
Notwithstanding par. (d)
, a dairy plant operator may not store, cool, separate, or clarify raw milk in a room used to unload bulk milk shipments if any of the following apply:
The dairy plant is a grade A dairy plant constructed or licensed after July 1, 1980.
The storage, cooling, separating, or clarifying operations were initiated after December 1, 1994.
Rooms, other than rooms adjacent to sleeping or living quarters, are considered separate, for purposes of this subsection, if they are fully separated by permanent floor-to-ceiling partitions and if doorways between the rooms are equipped with solid, tight-fitting, self-closing doors. Rooms adjacent to sleeping or living quarters must comply with sub. (11)
Water used in dairy plant operations, or as an ingredient in dairy products, shall be obtained from a source that complies with applicable provisions of ch. NR 811
. All water obtained for use in a dairy plant shall comply with the microbiological standards in ch. NR 809
. Water shall be available in consistently adequate quantity for all dairy plant operations, including processing, cleaning, handwashing, and drinking. The division may grant a conditional waiver for elevated levels of non-microbial contaminants as defined in ch. NR 809
in processing water or ingredient water.
If a dairy plant uses water from a privately owned water system, the dairy plant operator or, in the case of a grade A dairy plant, the division shall, at least once every 6 months, and after a repair or alteration to the water system, collect and analyze a sample of the water for compliance with the microbiological standards under s. NR 809.30
. If a dairy plant produces grade A and grade B products, a division representative shall collect and analyze the water samples. If the water supply is from more than one well, each well shall be sampled and tested. Each sample shall be taken upstream from any pressure tank or other water treatment equipment. Microbiological analyses shall be conducted in a laboratory certified under ch. ATCP 77
At the division's request, a dairy plant operator who receives water from a municipal source shall provide the division with documentation showing that the water complies with the microbiological standards under s. NR 809.30
Recirculated water may be used in a cooler or heat exchanger that may come in contact with any dairy product if it is all of the following:
Tested by the dairy plant operator at least semiannually or, in the case of a grade A dairy plant, by the department at least semiannually.
If a recirculating water system becomes contaminated, that system may not be used until it is properly treated and retested to ensure that the contamination has been eliminated. The freezing point depressants used in recirculating water systems shall be food or pharmaceutical grade, non-toxic propylene glycol, and shall not contain coliform bacteria as determined by sampling and analysis which the dairy plant operator has done at least semi-annually.
A dairy plant operator may use only potable water, or reclaimed water in compliance with sub. (9) (c)
, to produce culinary steam. In boilers used to produce culinary steam, boiler water additives shall comply with 21 CFR. 173.310
All of the following requirements apply to water that is transported to a dairy plant in a container or tank, for use in dairy plant operations:
The container or tank shall be thoroughly cleaned and sanitized before being filled.
The container or tank shall be sealed, and the water shall be protected from contamination during transit.
A food-contact appropriate, cleaned and sanitized pump, hose, and fittings shall be used to transfer water from the container or tank to a storage tank at the dairy plant, so that the water is not contaminated during transfer.
If a grade A dairy plant uses water to flush pasteurized milk or milk products from milk processing systems, that water shall be of a microbiological quality equivalent to that of pasteurized milk.
A dairy plant operator may use water reclaimed from heat exchanger processes or from the condensation of milk or dairy products if all the following apply:
The water is reclaimed from a heat exchanger process or by means of evaporation, reverse osmosis, or ultrafiltration.
Except as provided in par. (c)
, reclaimed water may not be used for any purpose requiring potable water unless all the following apply:
The department pre-inspects and pre-approves the reclamation system.
The reclaimed water contains less than 1 coliform bacterium per 100 ml. of water.
The organic content of the water is less than 12 mg. per liter as measured by the chemical oxygen demand or permanganate-consumed test, or the water has a standard turbidity of less than 5 units. The dairy plant operator shall use an automatic fail-safe monitoring device to identify, and automatically divert to a waste water system, any water reclaimed from the condensation of dairy products if that water fails to meet this standard.
The reclaimed water is of satisfactory organoleptic quality. The dairy plant operator shall sample and organoleptically test reclaimed water at weekly intervals.
Any chemicals used to suppress bacterial growth, tastes, or odors in the reclaimed water are registered for that use with the U.S. environmental protection agency. The dairy plant operator who uses any chemical to suppress bacterial growth, tastes, or odors shall comply with the chemical label instructions. An added chemical may not contain any substance that may contaminate dairy products or limit the use of reclaimed water. An automatic proportioning device shall add the chemicals to the water before the water enters the storage tank. The dairy plant operator shall test reclaimed water at least daily to verify that each added chemical is present at an approved level.
The reclaimed water is stored in a properly constructed tank. The tank shall be constructed of a material that can be easily cleaned and sanitized and will not contaminate the water.
The dairy plant operator or, in the case of a grade A dairy plant, the division tests the reclaimed water for compliance with microbiological and organic content standards at least semi-annually. The operator shall test the reclaimed water for 14 working days after the department approves the reclamation system under subd. 1.
, and for at least 7 working days after any repairs or alterations to the system.
There are no cross-connections between reclaimed water lines and any public or private water system.
Reclaimed water from membrane processing of unpasteurized milk or unpasteurized dairy products shall be heat-treated for a time and at a temperature providing at least the same lethality against microorganisms as milk pasteurization.