Wisconsin Legislature: ATCP 65.58(3)(a)

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

(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.

(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:

(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.

(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.

(d) Discarded.

(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:

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

(b) A point immediately preceding each intermediate cooling.

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

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.

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

ATCP 65.56 Labeling pasteurized and unpasteurized products.

(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.

(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.

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

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

(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.

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

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

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

ATCP 65.58 Pasteurization time and temperature.

(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.

(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.

- See PDF for table

(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:

(a) 191° F. (89° C.) for 1.0 seconds.

(b) 194° F. (90° C.) for 0.5 seconds.

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

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

(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.

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 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.

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 (703) 790-0295, 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.

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

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.

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.

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

ATCP 65.64 Aseptic processing and packaging.

(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.

(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.

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.

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

ATCP 65.66 Pasteurization records.

(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.

(2) Batch pasteurization records. Except as provided in sub. (3), batch pasteurization records shall include all the following:

(a) Each date, including the year, on which dairy products are pasteurized.

(b) The identification number or location of each pasteurization time and temperature recording chart, if more than one is used.

(d) The pasteurization holding time, as shown on the temperature recording chart, for each batch of pasteurized product. Records shall include filling and emptying times, if applicable.

(e) The temperature reading on the airspace thermometer at the start and end of the pasteurization holding period, and at specific times identified as points on the temperature recording chart.

(f) The temperature reading on the indicating thermometer at the start of the pasteurization holding period, and at a specific time identified as a point on the temperature recording chart.

(g) The name and quantity of dairy product included in each pasteurization batch shown on the temperature recording chart.

(h) A record of any unusual circumstances that occurred during each batch pasteurization.

(i) The name of the dairy plant.

(j) The signature or initials of the dairy plant operator, or a responsible employee or agent of the operator.

(3) HTST and HHST pasteurization records. Pasteurization records for HTST and HHST pasteurization operations shall include all the following:

(a) Each date, including the year, on which dairy products are pasteurized.

(b) The identification number or location of each pasteurization time and temperature recording chart, if more than one is used.

(d) The temperature reading on the indicating thermometer at the start of each pasteurization run, and at a specific time identified as a point on the temperature recording chart.

(e) Documentation, on the temperature recording chart, of every time period during which the flow-diversion device on the pasteurizer is in the forward-flow position.

(f) The cut-in and cut-out product temperatures at the beginning of each HTST pasteurization run. The pasteurizer operator shall record these temperatures daily on the temperature recording chart.

(g) The temperature reading on the indicating thermometer whenever the temperature recording chart for the pasteurization system is changed.

(h) The name and quantity of dairy product included in each pasteurization run shown on the temperature recording chart.

(i) A record of any unusual circumstances that occurred during each pasteurization run.

(j) The name of the dairy plant.

(k) The signature or initials of the dairy plant operator, or a responsible employee or agent of the operator.

(4) Flow records for HTST and HHST pasteurizers with meter based timing systems. In addition to requirements in sub. (3), pasteurization records for HTST and HHST pasteurization operations with meter based timing systems shall include all of the following:

(a) Each date, including the year, on which dairy products are pasteurized.

(b) The identification number or location of each pasteurization time and flow-rate recording chart, if more than one is used.

(d) A continuous flow-rate recording chart record of the status of the high and low flow/loss of signal alarms.

(e) The name and quantity of dairy product pasteurized in each pasteurization run shown on the flow-rate recording chart.

(f) A record of any unusual circumstances that occurred during each pasteurization run.

(g) The name of the dairy plant.

(h) The signature or initials of the dairy plant operator or a responsible employee or agent of the operator.

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

ATCP 65.68 Pasteurizer testing.

(1) General. The division shall test and seal pasteurization systems according to this section. Except as provided under sub. (6), no person may use any pasteurization system to pasteurize grade A or grade B dairy products unless that system bears the unbroken seals applied by the department under sub. (5).

(2) Test procedure. The division shall test grade A and grade B pasteurization systems according to the procedure specified in Appendix I of the PMO.

Note: PMO Appendix I 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.

(3) Test frequency; grade A pasteurizers. The division shall test each grade A pasteurization system at the following times:

(a) Before the pasteurization system is first put into operation.

(b) At least once every 3 months, except that a holding time test may be conducted at least once every 6 months.