Chapter ATCP 65

ATCP 65.28 Note Note: The “3-A Sanitary Standards” and ”3-A Accepted Practices” listed in Appendix A are published by 3-A Sanitary Standards, Inc., 1451 Dolley Madison Boulevard, Suite 210, McLean, VA 22101-3850, telephone [phone], website www.3-a.org. Copies are on file with the division and the legislative reference bureau and may be obtained from the ”3-A Sanitary Standards, Inc. Online Store” at http://www.techstreet.com.

ATCP 65.28(1)(b) (b) Equipment and utensils shall be readily accessible for cleaning and inspection and shall be designed and constructed so that they can be easily cleaned. Equipment and utensils shall be kept clean and in good repair.

ATCP 65.28(1)(c) (c) Tanks, vats, separators, and other containers used to store or process dairy products shall be designed or equipped with appropriate devices to prevent surface condensation and drainage from entering the container.

ATCP 65.28(1)(d) (d) Pipeline systems used to convey dairy products shall contain no dead ends in which dairy products may collect. Pipelines and other equipment shall be designed and constructed to prevent cross-contamination between pasteurized dairy products, unpasteurized dairy products, and cleaning and sanitizing solutions.

ATCP 65.28(1)(e) (e) If it is necessary to disassemble any equipment or utensil to inspect a product contact surface, all tools needed for the disassembly shall be readily available at the dairy plant.

ATCP 65.28(1)(f) (f) Water hoses used to wash dairy products or add ingredient water to dairy products shall be constructed of approved food grade materials and shall be used and stored in a sanitary manner.

ATCP 65.28(1)(g) (g) A dairy plant operator may use sanitary flexible pipelines to transfer partially processed products in the intermediate stages of production or to load and unload bulk loads of milk from transport vehicles, if all the following apply:

ATCP 65.28(1)(g)1. 1. The use of rigid pipelines for that purpose in a sanitary manner is not possible due to the location of walls, floors, ceiling or other equipment.

ATCP 65.28(1)(g)2. 2. The dairy plant operator properly cleans and sanitizes the flexible pipeline after completing the transfer of product, or at least once during each day of use.

ATCP 65.28(1)(g)3. 3. The operator uses only a length of flexible pipeline necessary to conduct the transfer operation.

ATCP 65.28(2) (2) Product contact surfaces.

ATCP 65.28(2)(a) (a) Product contact surfaces of equipment and utensils shall be made of materials that are smooth, impervious, nontoxic, noncorrosive, nonabsorbent, and durable under foreseeable use conditions. A product contact surface shall be constructed of one or more of the following materials unless the division specifically authorizes another material in writing:

ATCP 65.28(2)(a)1. 1. Stainless steel of the American Iron and Steel Institute 300 series, or an equally corrosion resistant metal.

ATCP 65.28(2)(a)2. 2. Heat resistant glass.

ATCP 65.28(2)(a)3. 3. Plastic, rubber, or rubber-like materials that are fat resistant and insoluble; that are resistant to scratching, scoring, decomposition, crazing, chipping, and distortion under normal use conditions; that do not impart chemicals, flavor, or odor to milk; and that maintain their original properties under conditions of repeated use.

ATCP 65.28(2)(b) (b) Product contact surfaces shall be easily cleanable and shall be free of breaks, open seams, cracks, or similar defects. Product contact surfaces shall not impart any odor, color, taste, or adulterating substance to food. Product contact surfaces, other than product contact surfaces of approved C-I-P systems, shall be readily accessible for manual cleaning. Joints and fittings shall be of sanitary design and construction.

ATCP 65.28(3) (3) Location and installation of dairy processing equipment.

ATCP 65.28(3)(a) (a) Dairy processing equipment shall be located and installed to prevent overcrowding and to prevent contamination of dairy products or product contact surfaces by splash, condensation, or manual contact.

ATCP 65.28(3)(b) (b) Dairy processing equipment that cannot be easily moved shall be installed in a manner that prevents liquid or debris from accumulating under or around the equipment.

ATCP 65.28(3)(c) (c) Dairy processing equipment shall be installed so that there is adequate clearance on all sides for cleaning and maintenance. This does not apply to that portion of a tank or container that is designed to protrude into or through a wall or the ceiling of a dairy plant.

ATCP 65.28(4) (4) Bulk storage tanks; venting. A tank used for the bulk storage of milk, whey, or liquid food products shall be equipped with an air filter to prevent contamination of tank contents, or shall be vented only to one of the following:

ATCP 65.28(4)(a) (a) A processing area.

ATCP 65.28(4)(b) (b) A tank gallery room that complies with processing area sanitation standards under this chapter.

ATCP 65.28(5) (5) Measuring devices and controls.

ATCP 65.28(5)(a) (a) Every storage tank, freezer, and cold storage compartment used to hold milk or dairy products shall be equipped with a thermometer or other device that accurately indicates the temperature in the storage tank, freezer, or compartment.

ATCP 65.28(5)(b) (b) Each of the following bulk storage tanks shall be equipped with a 7-day temperature recording device that shows the temperature of dairy products stored in that bulk storage tank:

ATCP 65.28(5)(b)1. 1. Every bulk storage tank used to store grade A milk or grade A dairy products for longer than 24 hours.

ATCP 65.28(5)(b)2. 2. A silo tank installed after December 1, 1994.

ATCP 65.28(5)(c) (c) Instruments and controls used for measuring, regulating, and recording temperature, pH, acidity, water activity, or other conditions that control or prevent the growth of undesirable microorganisms in milk or dairy products shall be accurate, fully functional, and adequate for their intended use.

ATCP 65.28(6) (6) Lubrication. Equipment shall be designed and constructed so that gear and bearing lubricants do not come in contact with milk or dairy products, ingredients, or product contact surfaces. Food grade lubricants shall be used if there is any chance that lubricants may come in contact with milk or dairy products, ingredients or product contact surfaces.

ATCP 65.28(7) (7) Cleaning and sanitizing equipment and utensils.

ATCP 65.28(7)(a) (a) A dairy plant operator shall clean and sanitize product contact surfaces of equipment and utensils to keep them at all times in sanitary condition. Sanitizing methods shall comply with s. ATCP 65.34.

ATCP 65.28(7)(b) (b) Except as provided in pars. (c) to (f), a dairy plant operator shall at a minimum clean all product contact surfaces of equipment and utensils after each day’s use, sanitize those surfaces before each day’s use, and clean and sanitize those surfaces before any change in use that may cross-contaminate dairy products with major food allergens, as defined in s. ATCP 70.02 (29), or other contaminants.

ATCP 65.28(7)(c) (c) A dairy plant operator shall clean and sanitize tanks used to store liquid dairy products whenever the dairy plant operator empties those tanks. Tanks used to store raw milk or grade A dairy products shall be emptied at least once every 72 hours.

ATCP 65.28(7)(d) (d) A dairy plant operator shall clean evaporators at the end of a continuous operation, not to exceed 44 hours.

ATCP 65.28(7)(e) (e) Paragraph (b) does not apply to any of the following equipment, provided that the dairy plant operator cleans and sanitizes the equipment according to manufacturer specifications or a cleaning and sanitizing process approved under par. (f), and complying with par. (a):

ATCP 65.28(7)(e)1. 1. Drying equipment.

ATCP 65.28(7)(e)2. 2. Cloth collector systems.

ATCP 65.28(7)(e)3. 3. Dry product packaging equipment and storage containers.

ATCP 65.28(7)(e)4. 4. Equipment used in brining, aging, curing, and dry product blending processes.

ATCP 65.28(7)(e)5. 5. Reverse osmosis equipment that utilizes a permeate stream from a previously pasteurized product that has passed through a nanofiltration system achieving an efficiency of not more than 1,000 daltons.

ATCP 65.28(7)(e)6. 6. Food contact surfaces of equipment used only to process foods or food ingredients with water activity not exceeding 0.85, or foods that are not potentially hazardous foods.

ATCP 65.28(7)(e)7. 7. Food contact surfaces located downstream from the sterilization step in an aseptic processing and packaging system, provided that system sterility is maintained. If system sterility is not maintained, the surfaces shall be cleaned, sanitized, and sterilized before processing.

ATCP 65.28(7)(f) (f) The division may authorize an alternative cleaning and sanitizing schedule for continuously-operated equipment, in lieu of the schedule under par. (b), based on a proposal under par. (g). The division’s authorization of a proposal for cleaning and sanitizing of equipment in contact with grade A dairy products is contingent upon consultation with, and acceptance of the proposal by, the US food and drug administration, and shall be valid for 5 years. The division’s authorization may be renewed after a review requested in writing by the dairy plant operator. A dairy plant operator shall adhere to the practices described in an approved proposal. A dairy plant operator may not alter practices described in an approved proposal without division approval. Division approval of a proposed changes for cleaning and sanitizing of equipment in contact with grade A dairy products is contingent upon consultation with, and acceptance of the changes by, the US food and drug administration, and shall be valid for 5 years.

ATCP 65.28(7)(g) (g) A dairy plant operator’s proposal, under par. (f), shall include all of the following:

ATCP 65.28(7)(g)1. 1. A complete description of the continuously-operated equipment covered by the proposal, including relevant design and sanitation features.

ATCP 65.28(7)(g)2. 2. A complete description of the processing, handling, or storage operations for which the continuously-operated equipment is used. The description shall identify the types of dairy products involved, and the type and duration of continuous operations conducted.

ATCP 65.28(7)(g)3. 3. A complete description of the cleaning and sanitizing procedure proposed by the dairy plant operator. The description shall include cleaning and sanitizing frequency, cleaning and sanitizing methods and materials, and other relevant process parameters such as time, temperature, and concentration. The description shall include relevant process diagrams and specifications.

ATCP 65.28(7)(g)4. 4. A certification, by the dairy plant operator, that the proposed cleaning and sanitizing procedure complies with par. (a). The certification shall be based on a thorough hazard analysis and safety assessment by qualified personnel.

ATCP 65.28(7)(h) (h) A dairy plant operator shall keep records to document, on an ongoing basis, the operator’s compliance with this subsection.

ATCP 65.28(8) (8) Storing clean equipment and utensils. Clean equipment and utensils, unless stored in an approved sanitizing solution, shall be stored so that they drain dry. Utensils and equipment components disassembled for cleaning shall be stored above the floor in metal racks or other storage facilities which allow drainage. Clean equipment and utensils shall be protected from contamination prior to use.

ATCP 65.28(9) (9) Single-service utensils. Single-service utensils shall be stored in the original containers in which they were received, or in other closed containers that will protect them from contamination until they are used. Single-service utensils shall not be reused.

ATCP 65.28(10) (10) Cleaning compounds, detergents, and sanitizers; storage and labeling. Cleaning compounds, detergents, and sanitizers used in a dairy plant shall be clearly labeled. When they are not being used, they shall be stored in designated areas and in an appropriate manner so that they do not contaminate dairy products, ingredients, equipment, or utensils.

ATCP 65.28 History History: CR 14-073: cr. Register August 2016 No. 728, eff. 9-1-16; correction in (7) (b) made under s. 13.92 (4) (b) 7., Stats., Register August 2016 No. 728; correction in (7) (b) made under s. 13.92 (4) (b) 7., Stats., Register January 2020 No. 769.

ATCP 65.30 ATCP 65.30 C-I-P systems.

ATCP 65.30(1) (1) Construction and maintenance; general. C-I-P systems shall be designed, constructed, installed, and maintained in compliance with s. ATCP 65.28.

ATCP 65.30(2) (2) Cleaning and sanitizing C-I-P systems.

ATCP 65.30(2)(a) (a) A dairy plant operator shall clean and sanitize all C-I-P systems in compliance with s. ATCP 65.28 (7). Surfaces that cannot be cleaned and sanitized by C-I-P procedures shall be cleaned and sanitized manually or by a clean-out-of-place mechanical process.

ATCP 65.30(2)(b) (b) A dairy plant operator shall keep records on the cleaning and sanitizing of all C-I-P systems. The records shall identify every C-I-P system that has been cleaned and sanitized, the date and time when each C-I-P system was cleaned and sanitized, the temperature of the cleaning and sanitizing solutions, and the length of time for which the C-I-P system was exposed to the cleaning and sanitizing solutions. Records shall be made at the time the cleaning and sanitizing process is completed. Records shall be signed or initialed by a responsible person at the dairy plant. The division shall review the records as part of every routine inspection of the dairy plant.

ATCP 65.30(3) (3) Review of plans.

ATCP 65.30(3)(a) (a) Before installing a C-I-P system or adding equipment to any existing C-I-P system, the dairy plant operator shall submit to the division a plan for the installation or addition. The plan shall clearly describe each C-I-P circuit at a level of detail sufficient to permit review by the division within the time periods specified under this subsection.

ATCP 65.30(3)(b) (b) Plans for a C-I-P system, under par. (a), shall include the manufacturer’s specifications for the system, including the manufacturer’s specifications for operating, maintaining, cleaning, and sanitizing the system.

ATCP 65.30(3)(c) (c) Within 20 business days after any person files plans with the division under this subsection, the division shall return its comments or objections, if any, in writing.

ATCP 65.30 History History: CR 14-073: cr. Register August 2016 No. 728, eff. 9-1-16.

ATCP 65.32 ATCP 65.32 Dairy product packages.

ATCP 65.32(1) (1) General.

ATCP 65.32(1)(a) (a) Dairy product packages shall be of sanitary design and construction. Packages shall be designed and constructed to protect packaged dairy products from reasonably foreseeable contaminants.

ATCP 65.32(1)(b) (b) Product contact surfaces of dairy product packages shall be smooth, nontoxic, noncorrosive, nonabsorbent, and durable under foreseeable use conditions. Product contact surfaces shall not impart any odor, color, taste, or adulterating substance to packaged dairy products.

ATCP 65.32(1)(c) (c) Dairy product packages shall be clean, sanitary, and free of any extraneous or deleterious substance. Dairy products shall not be sold or distributed in packages with a broken seal or that are damaged to the extent that package contents could become adulterated as a result of the damage.

ATCP 65.32(1)(d) (d) Single-service packages shall be made of clean and sanitary materials, shall be protected from contamination prior to use, shall be handled in a sanitary manner, and shall be clean and sanitary at the time of use. Single service packages shall not be re-used.

ATCP 65.32(2) (2) Grade A dairy product packages.

ATCP 65.32(2)(a) (a) The residual bacteria count on product contact surfaces of grade A dairy product packages shall not exceed one per milliliter of capacity when the rinse test is used, or 50 per 8 square inches (one per square centimeter) when the swab test is used, in 3 out of 4 samples randomly taken and analyzed on a given day. Product contact surfaces shall be free of coliform bacteria as determined using a rinse test or a swab test.

ATCP 65.32(2)(b) (b) A grade A dairy product package shall be designed so that the product, the package pouring lip if any, and the package opening rim and area are protected from contamination during handling, storage, and initial opening. A grade A dairy product package shall be designed so that it cannot be opened without breaking the cap or closure seal, or leaving other readily apparent evidence that the package has been opened.

ATCP 65.32(2)(c) (c) Product contact surfaces of multi-use packages used for grade A milk or dairy products shall be constructed of one or more of the following materials unless the division specifically authorizes another material in writing:

ATCP 65.32(2)(c)1. 1. Stainless steel of the Iron and Steel Institute 300 series or an equally corrosion resistant metal.

ATCP 65.32(2)(c)2. 2. Heat resistant glass.

ATCP 65.32(2)(c)3. 3. Plastic materials that maintain their original properties under repeated use conditions; that are fat resistant and insoluble; and that are resistant to scratching, scoring, decomposition, crazing, chipping, and distortion under normal use conditions.

ATCP 65.32(2)(d) (d) Product contact surfaces of multi-use packages used to contain grade A milk or dairy products shall have rounded corners, and shall be easily cleanable.

ATCP 65.32(2)(e) (e) Multi-use packages used to contain grade A milk or dairy products shall be effectively cleaned and sanitized before being reused. Cleaning and sanitizing procedures shall remove all extraneous matter and potential adulterants from each package. Sanitizing procedures shall comply with s. ATCP 65.34. If returnable glass bottles are sanitized in an automatic bottle washer by soaking those bottles in a caustic solution, the sanitizing procedure shall comply with sub. (3).

ATCP 65.32(2)(f) (f) Multi-use packages used to contain grade A milk or dairy products shall be inspected before they are reused. Inspection shall be adequate to detect extraneous materials, adulterants, and damage to product contact surfaces. Inspection shall be performed on surfaces lighted in compliance with s. ATCP 65.24 (5) (c).

ATCP 65.32(2)(g) (g) No multi-use plastic package may be reused for grade A milk or dairy products unless that package is tested for the presence of volatile organic compounds using method ASTM D 3530 or an equivalent method approved by the department before the package is filled. An automatic testing device, capable of detecting volatile organic compounds at levels of public health significance, shall be used to test each package. The testing device shall be installed in conjunction with the dairy product packaging apparatus so that no packages can be filled unless the testing device is operating properly, and so that packages containing unsatisfactory levels of volatile organic compounds are automatically made unusable. The dairy plant operator shall test the system daily with a test solution consisting of 0.5 ppm petroleum distillate or another test solution approved in writing by the division.

ATCP 65.32 Note Note: A copy of ASTM D 3530 may be obtained from ASTM International, P.O. Box C700, West Conshohocken, PA 19428-2959; 1-877-909-2786; www.astm.org.

ATCP 65.32(2)(h) (h) No plastic multi-use package may be used to contain grade A milk or dairy products unless all of the following requirements are met:

ATCP 65.32(2)(h)1. 1. The package is identified to show the plant at which the package was manufactured, the date of manufacture, and the type and class of plastic material used. This information may be coded if the code is provided to the division.

ATCP 65.32(2)(h)2. 2. The phrase “Use only for food” appears on the package.

ATCP 65.32(2)(h)3. 3. The division has provided a written approval of a prototype of the package.

ATCP 65.32(2)(i) (i) Single-service packages used to contain grade A milk or dairy products shall be manufactured by a manufacturer listed in the “Certified Manufacturers of Single-Service Containers and Related Products” published online by the Food and Drug Administration, Public Health Service, United States Department of Health and Human Services.

ATCP 65.32 Note Note: Copies of ”Certified Manufacturers of Single-Service Containers and Related Products” are available online at http://www.fda.gov/food/guidanceregulation/federalstatefoodprograms/ucm2007965.htm or from the Milk Safety Team, HFS-626, Food and Drug Administration, Public Health Service, United States Department of Health and Human Services, 5100 Paint Branch Parkway, College Park, MD 20740-3835.

ATCP 65.32(2)(j) (j) Packaged grade A milk and dairy products shall be conspicuously labeled as grade A milk or dairy products.