Chapter ATCP 65

ATCP 65.50 History History: CR 14-073: cr. Register August 2016 No. 728, eff. 9-1-16.

subch. IV of ch. ATCP 65 Subchapter IV — Pasteurization

ATCP 65.52 ATCP 65.52 Unpasteurized milk sales prohibited; exemptions. No person may sell or distribute unpasteurized milk or dairy products to consumers or to any person for resale or redistribution in unpasteurized form to consumers. This section does not prohibit any of the following:

ATCP 65.52(1) (1) The sale or distribution of milk or dairy products that are heat sterilized in hermetically sealed containers.

ATCP 65.52(2) (2) The distribution of unpasteurized fluid milk, produced on a dairy farm, to any of the following:

ATCP 65.52(2)(a) (a) The milk producer who is licensed under s. ATCP 65.02 (1) to operate that dairy farm, and who, as license holder, assumes legal responsibility for dairy farm and milking operations.

ATCP 65.52(2)(b) (b) An individual who has a bona fide ownership interest in the dairy farm and milking operation under par. (a), if the milk producer operating the dairy farm and milking operation is a legal entity other than an individual or married couple.

ATCP 65.52(2)(c) (c) A family member or nonpaying household guest who consumes the milk at the home of an individual milk producer or bona fide owner under par. (a) or (b).

ATCP 65.52(3) (3) The sale or distribution of unpasteurized milk, produced on a dairy farm, to the employees of that dairy farm.

ATCP 65.52(4) (4) The incidental sale of unpasteurized milk to a consumer at the dairy farm where the milk is produced. A sale is not incidental if the consumer subsequently sells the milk or distributes the milk, other than distribution for consumption by the consumer, the consumer’s family, or the consumer’s nonpaying household guests. A sale is not incidental if it is made in the regular course of business, or is preceded by any advertising, offer or solicitation made to the general public through any communications medium.

ATCP 65.52 History History: CR 14-073: cr. Register August 2016 No. 728, eff. 9-1-16.

ATCP 65.54 ATCP 65.54 Pasteurization required.

ATCP 65.54(1) (1) Except as provided under sub. (2), every dairy product shall be pasteurized at the dairy plant where that dairy product is manufactured.

ATCP 65.54(2) (2) Subsection (1) does not apply to any of the following:

ATCP 65.54(2)(a) (a) A dairy product shipped in bulk to another dairy plant for use in manufacturing dairy products, provided that the shipment is accompanied by a bill of lading that identifies the dairy product as unpasteurized.

ATCP 65.54(2)(b) (b) A dairy product made entirely from dairy products that have been pasteurized at the same dairy plant.

ATCP 65.54(2)(c) (c) Ice cream or frozen dessert made from pasteurized ice cream mix or pasteurized frozen-dessert mix, provided that no unpasteurized dairy product is added to the pasteurized mix.

ATCP 65.54(2)(d) (d) A dairy product for which the standard of identity provides that the dairy product and its ingredients need not be pasteurized.

ATCP 65.54(2)(e) (e) A dairy product that is sterilized and packaged in a hermetically sealed package.

ATCP 65.54(2)(f) (f) Cream, skim milk, or low-fat milk that have been treated with heat to an extent less than pasteurization, and then shipped in bulk to another dairy plant for use in manufacturing dairy products, provided that the bulk shipment is accompanied by a bill of lading that identifies the contents of the bulk shipment as being unpasteurized and heat-treated. The heat-treated cream, skim milk, or low-fat milk may be heated not more than once for separation purposes, to a temperature that is not less than 125° F. (52° C.) nor more than 161° F. (72° C.). Heat-treated cream may be heated to a greater extent, up to a temperature of 166° F. (75° C.) in a continuing heating process, if further heating is necessary to deactivate enzymes for functional reasons. Cream, skim milk, and low-fat milk, after being heated to an extent less than pasteurization, shall immediately be cooled to a temperature of 45° F. (7° C.) or less.

ATCP 65.54(2)(g) (g) Dried condensed whey produced by drying condensed whey that was previously pasteurized at another dairy plant, provided that all of the following apply:

ATCP 65.54(2)(g)1. 1. The pasteurized condensed whey received for drying contained at least 40% total solids, and was partially crystallized by cooling at the dairy plant where it was pasteurized.

ATCP 65.54(2)(g)2. 2. The partially crystallized condensed whey was kept at a temperature of 45° F. (7° C.) or less prior to drying.

ATCP 65.54(2)(g)3. 3. The bulk milk tanker used to transport the partially crystallized condensed whey was washed and sanitized immediately before filling, was sealed immediately after filling, and remained sealed until it was unloaded at the receiving dairy plant.

ATCP 65.54(2)(g)4. 4. The receiving dairy plant unloaded the partially crystallized condensed whey using unloading pumps and pipelines that are used only for that purpose and have been cleaned and sanitized as a separate C-I-P circuit before use in unloading.

ATCP 65.54(2)(h) (h) Grade B dairy products produced by adding previously pasteurized and dried dairy products with a water activity not greater than 0.85 to previously pasteurized grade B dairy products, if approved in writing by the division.

ATCP 65.54(2)(i) (i) Grade B dairy products produced by adding previously pasteurized packaged dairy products to previously pasteurized grade B dairy products, if approved in writing by the division.

ATCP 65.54(3) (3) A dairy product, required to be pasteurized under sub. (1), shall be pasteurized by, or under the direct supervision of, a pasteurizer operator who has successfully completed any of the following:

ATCP 65.54(3)(a) (a) A pasteurization training course, of at least 8 hours duration, provided by the University of Wisconsin or an equivalent course approved by the division.

ATCP 65.54(3)(b) (b) A competency examination approved by the division.

ATCP 65.54(4) (4) If a dairy product standard of identity requires that any ingredient of that product be pasteurized, the ingredient shall be pasteurized according to s. ATCP 65.58.

ATCP 65.54(5) (5) Except as provided in subs. (6) to (8), a dairy product that is required to be pasteurized under sub. (1) or (4) shall be pasteurized before it is introduced into any membrane or condensing processing system.

ATCP 65.54(6) (6) Subsection (5) does not apply to grade B whey or whey product if at least one of the following applies:

ATCP 65.54(6)(a) (a) The whey or whey product is derived from milk pasteurized in the same dairy plant.

ATCP 65.54(6)(b) (b) The whey is acid whey, which has a pH less than 4.7 when drawn from the curd.

ATCP 65.54(6)(c) (c) The whey or whey product is processed in a membrane processing system that complies with sub. (9) and is designed and maintained to keep the whey or whey product at a temperature of 65° F. (18.3° C.) or below during processing. If the whey or whey product temperature exceeds 65° F. (18.3° C.) for more than 15 minutes during processing, or exceeds 70° F. (21.1° C.) at any time during processing, the whey or whey product shall be immediately diverted from moving beyond the membrane processing system by means of automatic controls. The diverted product shall be treated in one of the following ways:

ATCP 65.54(6)(c)1. 1. Recycled through the membrane processing system and subjected to cooling. The diverted product may proceed beyond the membrane processing system when the product temperature falls to 65° F. (18.3° C.) or below.

ATCP 65.54(6)(c)2. 2. Cooled in a system other than the membrane processing system until the temperature falls to 45° F. (7° C.) or below, and may then be reintroduced into the membrane processing system.

ATCP 65.54(6)(c)3. 3. Pasteurized in a pasteurization system, and may then be reintroduced into the membrane processing system.

ATCP 65.54(6)(c)4. 4. Discarded.

ATCP 65.54(7) (7) Subsection (5) does not apply to grade A whey or whey product that is pasteurized in a membrane processing system that complies with sub. (9) if at least one of the following apply:

ATCP 65.54(7)(a) (a) The whey is acid whey, which has a pH less than 4.7 when drawn from the curd.

ATCP 65.54(7)(b) (b) The membrane processing system is designed and maintained to keep the whey or whey product at a temperature of 45° F. (7° C.) or below during processing.

ATCP 65.54(8) (8) Subsection (5) does not apply to unpasteurized milk that is processed, before pasteurization, in a membrane processing system that complies with sub. (9) and is designed and maintained to keep the milk at a temperature of 65° F. (18.3° C.) or below during processing. If the milk temperature exceeds 65° F. (18.3 ° C.) for more than 15 minutes during processing, or exceeds 70° F. (21.1° C.) at any time during processing, the milk shall be immediately diverted from moving beyond the membrane processing system by means of automatic controls. The diverted milk shall be treated in any of the following ways:

ATCP 65.54(8)(a) (a) Recycled through the membrane processing system and subjected to cooling. The diverted product may proceed beyond the membrane processing system when the product temperature falls to 65° F. (18.3° C.) or below.

ATCP 65.54(8)(b) (b) Cooled in a system other than the membrane processing system until the temperature falls to 45° F. (7° C.) or below, and may then be reintroduced into the membrane processing system.

ATCP 65.54(8)(c) (c) Pasteurized in a pasteurization system, and may then be reintroduced into the membrane processing system.

ATCP 65.54(8)(d) (d) Discarded.

ATCP 65.54(9) (9) A membrane processing system under sub. (6) (c), (7), or (8) shall be equipped with temperature monitoring and recording devices that comply with Appendix H, Subsection IV of the PMO. At a minimum, the system shall monitor and record product temperature at all of the following points during processing:

ATCP 65.54(9)(a) (a) The point at which the dairy product enters the system.

ATCP 65.54(9)(b) (b) A point immediately preceding each intermediate cooling.

ATCP 65.54(9)(c) (c) A point immediately preceding final cooling.

ATCP 65.54(9)(d) (d) The point at which the product exits the system.

ATCP 65.54 Note Note: PMO Appendix H, Subsection IV is on file with the division and the legislative reference bureau. Copies may be obtained from the division at cost or online at http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Milk.

ATCP 65.54 History History: CR 14-073: cr. Register August 2016 No. 728, eff. 9-1-16.

ATCP 65.56 ATCP 65.56 Labeling pasteurized and unpasteurized products.

ATCP 65.56(1) (1) If a dairy product is pasteurized or made exclusively from pasteurized ingredients, the label on every shipping container of that dairy product shall clearly and conspicuously state that the product is “pasteurized” or “UHT pasteurized,” as appropriate. Every label under this subsection shall also include the name and address, or the unique identification number, of the dairy plant where the dairy product was pasteurized.

ATCP 65.56(2) (2) Except as provided under sub. (3) or (4), if a dairy product is not pasteurized or made exclusively from pasteurized ingredients, the label on every shipping container and consumer package of that dairy product shall state that the product is unpasteurized.

ATCP 65.56(3) (3) Subsection (2) does not apply to cheese that meets all of the following requirements:

ATCP 65.56(3)(a) (a) The standard of identity for the cheese provides that the cheese may be made from unpasteurized dairy products.

ATCP 65.56(3)(b) (b) The cheese is held for at least 61 days at a temperature not less than 35° F. before being distributed for retail sale, or for further processing without pasteurization.

ATCP 65.56(3)(c) (c) The label on every shipping container and consumer package of cheese states that the cheese is “aged over 60 days.”

ATCP 65.56(4) (4) Subsection (2) does not apply to a dairy product that is sterilized and sealed in a hermetically sealed container.

ATCP 65.56 Note Note: See dairy product labeling requirements in subch. III.

ATCP 65.56 History History: CR 14-073: cr. Register August 2016 No. 728, eff. 9-1-16.

ATCP 65.58 ATCP 65.58 Pasteurization time and temperature.

ATCP 65.58(1) (1) If a dairy product is required to be pasteurized under s. ATCP 65.54, the dairy product shall be pasteurized according to this subchapter unless the division authorizes in writing a different but equally effective pasteurization system or method. Alternative times and temperatures for pasteurizing grade A milk and milk products shall be recognized by the United States food and drug administration. All of the dairy product shall be heated to the required temperature and continuously held at or above the required temperature for the required period of time. Pasteurization equipment shall be equipped with accurate measuring, recording, and control devices, as required by ss. ATCP 65.60 and 65.62, to ensure that the time and temperature requirements under this section are met.

ATCP 65.58(2) (2) Dairy products identified in table 2, unless UHT pasteurized under sub. (3), shall be pasteurized in a batch pasteurizer tested in accordance with s. ATCP 65.68 or HTST pasteurizer tested in accordance with s. ATCP 65.68 at or above the temperature specified in the table for at least the length of time specified in the table.

ATCP 65.58(3) (3) A dairy plant operator may use an HHST pasteurizer as an alternative to an HTST pasteurizer. An HHST pasteurizer shall heat and hold a dairy product at one of the following temperatures for the corresponding length of time:

ATCP 65.58(3)(a) (a) 191° F. (89° C.) for 1.0 seconds.

ATCP 65.58(3)(b) (b) 194° F. (90° C.) for 0.5 seconds.

ATCP 65.58(3)(c) (c) 201° F. (94° C.) for 0.1 seconds.

ATCP 65.58(3)(d) (d) 204° F. (96° C.) for 0.05 seconds.

ATCP 65.58(3)(e) (e) 212° F. (100° C.) for 0.01 seconds.

ATCP 65.58(4) (4) A UHT pasteurized dairy product shall be thermally processed at or above a temperature of 280° F. (138° C.) for at least 2 seconds.

ATCP 65.58 History History: CR 14-073: cr. Register August 2016 No. 728, eff. 9-1-16; correction in (3) (a) to (e) made under s. 35.17, Stats., Register August 2016 No. 728.

ATCP 65.60 ATCP 65.60 Batch pasteurization. Batch pasteurization equipment shall be of the non-coil type. Batch pasteurization equipment shall be constructed and operated so that pasteurization complies with item 16p (A) of the PMO and with applicable “3-A Sanitary Standards” and “3-A Accepted Practices” listed in ch. ATCP 65 Appendix A. Thermometers shall be constructed and operated in compliance with Appendix H, item IV of the PMO. The temperature of the air space above the pasteurized product shall be at least 5° F. (3° C.) higher than the minimum pasteurization temperature of the pasteurized product.

ATCP 65.60 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. Copies may be purchased from the “3-A Sanitary Standards, Inc. Online Store” at http://www.techstreet.com. Copies of the PMO are on file with the division and the legislative reference bureau.

ATCP 65.60 History History: CR 14-073: cr. Register August 2016 No. 728, eff. 9-1-16.

ATCP 65.62 ATCP 65.62 HTST and HHST pasteurization. Pasteurization by means of HTST or HHST pasteurization shall comply with the standards set forth in “3-A Accepted Practices for the Sanitary Construction, Installation, Testing and Operation of High-Temperature Short-Time and Higher Heat Shorter Time Pasteurizer Systems,” standard 3A 603-07 (November, 2005), published by 3-A Sanitary Standards, Inc.

ATCP 65.62 Note Note: Copies of the “3-A Accepted Practices for the Sanitary Construction, Installation, Testing, and Operation of High-Temperature Short-Time and Higher Heat Shorter Time Pasteurizer Systems,” standard 3A 603-07 (November, 2005) are on file with the division and the legislative reference bureau. Copies may be obtained from the “3-A Sanitary Standards, Inc. Online Store” at http://www.techstreet.com.

ATCP 65.62 History History: CR 14-073: cr. Register August 2016 No. 728, eff. 9-1-16.

ATCP 65.64 ATCP 65.64 Aseptic processing and packaging.

ATCP 65.64(1) (1) Grade A requirements. Grade A aseptic processing and packaging systems shall comply with standards specified in items 16p (B), (C), and (D) of the PMO and with applicable standards specified in 21 CFR 108.25, 108.35, 113, and 114.

ATCP 65.64(2) (2) Grade B requirements. Grade B aseptic processing and packaging systems shall comply with applicable standards specified in 21 CFR 113 and 21 CFR 114.

ATCP 65.64 Note Note: The PMO is on file with the division and the legislative reference bureau. Copies may be obtained from the division at cost or online at http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Milk.

ATCP 65.64 History History: CR 14-073: cr. Register August 2016 No. 728, eff. 9-1-16.

ATCP 65.66 ATCP 65.66 Pasteurization records.

ATCP 65.66(1) (1) General. A dairy plant operator shall keep pasteurization records for all dairy products pasteurized by the operator. Records shall cover all types of pasteurization operations, including batch operations, HTST operations, and HHST operations. Records shall comply with this section. The department shall review pasteurization records as part of each routine inspection of a dairy plant.