Chapter ATCP 65

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.

ATCP 65.66(2) (2) Batch pasteurization records. Except as provided in sub. (3), batch pasteurization records shall include all the following:

ATCP 65.66(2)(a) (a) Each date, including the year, on which dairy products are pasteurized.

ATCP 65.66(2)(b) (b) The identification number or location of each pasteurization time and temperature recording chart, if more than one is used.

ATCP 65.66(2)(c) (c) A continuous temperature recording chart temperature record for each batch of pasteurized product.

ATCP 65.66(2)(d) (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.

ATCP 65.66(2)(e) (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.

ATCP 65.66(2)(f) (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.

ATCP 65.66(2)(g) (g) The name and quantity of dairy product included in each pasteurization batch shown on the temperature recording chart.

ATCP 65.66(2)(h) (h) A record of any unusual circumstances that occurred during each batch pasteurization.

ATCP 65.66(2)(i) (i) The name of the dairy plant.

ATCP 65.66(2)(j) (j) The signature or initials of the dairy plant operator, or a responsible employee or agent of the operator.

ATCP 65.66(3) (3) HTST and HHST pasteurization records. Pasteurization records for HTST and HHST pasteurization operations shall include all the following:

ATCP 65.66(3)(a) (a) Each date, including the year, on which dairy products are pasteurized.

ATCP 65.66(3)(b) (b) The identification number or location of each pasteurization time and temperature recording chart, if more than one is used.

ATCP 65.66(3)(c) (c) A continuous temperature recording chart for each pasteurization run.

ATCP 65.66(3)(d) (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.

ATCP 65.66(3)(e) (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.

ATCP 65.66(3)(f) (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.

ATCP 65.66(3)(g) (g) The temperature reading on the indicating thermometer whenever the temperature recording chart for the pasteurization system is changed.

ATCP 65.66(3)(h) (h) The name and quantity of dairy product included in each pasteurization run shown on the temperature recording chart.

ATCP 65.66(3)(i) (i) A record of any unusual circumstances that occurred during each pasteurization run.

ATCP 65.66(3)(j) (j) The name of the dairy plant.

ATCP 65.66(3)(k) (k) The signature or initials of the dairy plant operator, or a responsible employee or agent of the operator.

ATCP 65.66(4) (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:

ATCP 65.66(4)(a) (a) Each date, including the year, on which dairy products are pasteurized.

ATCP 65.66(4)(b) (b) The identification number or location of each pasteurization time and flow-rate recording chart, if more than one is used.

ATCP 65.66(4)(c) (c) A continuous flow-rate recording chart record of the flow rate.

ATCP 65.66(4)(d) (d) A continuous flow-rate recording chart record of the status of the high and low flow/loss of signal alarms.

ATCP 65.66(4)(e) (e) The name and quantity of dairy product pasteurized in each pasteurization run shown on the flow-rate recording chart.

ATCP 65.66(4)(f) (f) A record of any unusual circumstances that occurred during each pasteurization run.

ATCP 65.66(4)(g) (g) The name of the dairy plant.

ATCP 65.66(4)(h) (h) The signature or initials of the dairy plant operator or a responsible employee or agent of the operator.

ATCP 65.66 History History: CR 14-073: cr. Register August 2016 No. 728, eff. 9-1-16.

ATCP 65.68 ATCP 65.68 Pasteurizer testing.

ATCP 65.68(1) (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).

ATCP 65.68(2) (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.

ATCP 65.68 Note 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.

ATCP 65.68(3) (3) Test frequency; grade A pasteurizers. The division shall test each grade A pasteurization system at the following times:

ATCP 65.68(3)(a) (a) Before the pasteurization system is first put into operation.

ATCP 65.68(3)(b) (b) At least once every 3 months, except that a holding time test may be conducted at least once every 6 months.

ATCP 65.68(3)(c) (c) Whenever a seal, under sub. (5), is broken.

ATCP 65.68(4) (4) Test frequency; grade B pasteurizers. The division shall test a grade B pasteurization system at the following times:

ATCP 65.68(4)(a) (a) Before the pasteurization system is first put into operation.

ATCP 65.68(4)(b) (b) At least once every 12 months.

ATCP 65.68(4)(c) (c) Whenever a seal, under sub. (5), is broken.

ATCP 65.68(5) (5) Department seals. When the division’s test confirms that a pasteurization system is operating correctly, the division shall apply seals that prevent any alteration of the system that would allow any unpasteurized milk or dairy product to flow through the system.

ATCP 65.68(6) (6) Broken seal.

ATCP 65.68(6)(a) (a) A dairy plant operator shall notify the division by telephone, electronic mail, or facsimile (FAX) transmission within 2 hours after the dairy plant operator breaks a seal applied by the division under sub. (5), or within 2 hours after a pasteurizing system malfunctions to the possible detriment of public health or safety. The dairy plant operator shall also notify the department in writing, on a form provided by the division, within 5 business days after the seal is broken or the system malfunctions.

ATCP 65.68(6)(b) (b) A dairy plant operator may not operate a pasteurizer after breaking a seal applied by the department under sub. (5), unless all of the following conditions are met:

ATCP 65.68(6)(b)1. 1. The dairy plant operator notifies the department under par. (a).

ATCP 65.68(6)(b)2. 2. The dairy plant operator determines and documents that pasteurization time and temperature requirements under s. ATCP 65.58 are met, and that the pasteurization system is repaired and functioning properly. Time and temperature records required by s. ATCP 65.66 shall be retained for at least 6 months.

ATCP 65.68(6)(b)3. 3. The dairy plant operator conducts phosphatase tests, under par. (d), if the pasteurizer is used to pasteurize milk without added flavors or ingredients other than vitamins. Phosphatase testing shall confirm that pasteurized milk without added flavors or ingredients other than vitamins contains less than 350 milli-units of detectable alkaline phosphatase per liter.

ATCP 65.68(6)(b)4. 4. A pasteurizer operator qualified under s. ATCP 65.54 (3) is present to operate the pasteurizer, or to supervise its operation.

ATCP 65.68(6)(c) (c) A dairy plant operator may not operate a pasteurizer for more than 10 calendar days after breaking a seal applied by the department under sub. (5), unless any of the following occurs:

ATCP 65.68(6)(c)1. 1. The division tests the pasteurizer and replaces the broken seal.

ATCP 65.68(6)(c)2. 2. A dairy plant operator or employee certified under sub. (7), tests the pasteurizer and replaces the broken seal on an interim basis, pending retesting and resealing by the department.

ATCP 65.68(6)(d) (d) Phosphatase testing, under par. (b) 3., shall comply with all of the following requirements:

ATCP 65.68(6)(d)1. 1. The dairy plant operator shall collect and analyze a test sample, directly from the pasteurizer system, at least once during every 4 hours of pasteurizer operations.

ATCP 65.68(6)(d)2. 2. The dairy plant operator shall store each test sample at a temperature below 45° F. (7° C.) until it is tested and shall analyze each sample within 48 hours after it is collected.

ATCP 65.68(6)(d)3. 3. The dairy plant operator shall analyze each sample using the Fluorophos ALP method, the Charm Paslite Alkaline Phosphatase method, or another test method approved in writing by the division.

ATCP 65.68(6)(d)4. 4. Tests shall be performed by an individual who is trained to conduct phosphatase tests on milk. If the dairy plant is a grade A dairy plant, tests shall be performed by a laboratory that the department has certified under ch. ATCP 77 or the PMO.

ATCP 65.68(7) (7) Emergency testing and sealing.

ATCP 65.68(7)(a) (a) The division may certify a dairy plant operator or employee to test and seal a pasteurization system in that dairy plant on an emergency basis under par. (b). To be certified under this paragraph, a dairy plant operator or employee shall have successfully completed a training course approved by the division. The division may suspend or revoke certification for cause.

ATCP 65.68(7)(b) (b) A dairy plant operator or employee certified under par. (a) may test and seal a pasteurization system in that dairy plant on an emergency basis, pending retesting and resealing by the division, under par. (c), if emergency testing and sealing is necessary to continue pasteurizing operations after the department’s seal is broken. Testing under this paragraph shall comply with the procedure specified under sub. (2).

ATCP 65.68(7)(c) (c) The division shall promptly retest and reseal a pasteurization system after the division receives notice, under sub. (6) (a), that its seal applied to that system has been broken. The division shall retest and reseal a pasteurization system, under this paragraph, regardless of whether the pasteurization system has been tested and sealed under par. (b). The division need not retest or reseal a pasteurization system that is withdrawn from service.

ATCP 65.68 History History: CR 14-073: cr. Register August 2016 No. 728, eff. 9-1-16.

subch. V of ch. ATCP 65 Subchapter V — Safety and Quality Standards

ATCP 65.70 ATCP 65.70 Milk quality standards for milk collected from a dairy farm. Milk received or collected from a dairy farm shall comply with all of the following standards at the time of receipt or collection:

ATCP 65.70(1) (1) Adulteration and odors. The milk shall not be visibly or otherwise adulterated, have any objectionable odor, or be abnormal in appearance or consistency.

ATCP 65.70(2) (2) Bacterial count.

ATCP 65.70(2)(a) (a) Limits. The bacterial count of grade A milk, as determined by a standard plate count, plate loop count or other method approved by the division under this subchapter, shall not exceed 100,000 per ml. The bacterial count of grade B milk shall not exceed 300,000 per ml. Except as provided under par. (f), a dairy plant operator is not required to reject milk shipments in response to a violation of this subsection unless the division suspends or revokes the milk producer’s license or grade A producer permit, or issues an order affecting the milk shipments under s. ATCP 65.927.

ATCP 65.70(2)(b) (b) Monthly testing required. During every month in which a dairy plant operator or a milk contractor licensed as a dairy plant receives milk from a milk producer, the dairy plant operator shall perform at least one standard plate count (SPC) or plate loop count (PLC) on a milk sample obtained from the producer under s. ATCP 82.12. A dairy plant operator shall perform tests under this section and s. ATCP 65.76 on the same milk samples.

ATCP 65.70(2)(c) (c) New milk producer; initial testing. A dairy plant operator or a milk contractor licensed as a dairy plant shall perform a SPC or PLC on a milk sample collected from the first milk shipment received from a milk producer. The dairy plant operator shall report the test result to the department and the milk producer within 7 days after the dairy plant operator obtains the test result.

ATCP 65.70(2)(d) (d) Monthly reporting. For each month in which a dairy plant operator or milk contractor licensed as a dairy plant receives milk from a milk producer, the dairy plant operator shall report to the division and the milk producer at least one representative test result under par. (b) for a milk shipment procured in that month. The dairy plant operator shall report the test result within 7 days after the operator obtains the test result.

ATCP 65.70(2)(e) (e) Representative test results. A test result is not representative, for reporting purposes under this subsection unless all the following apply:

ATCP 65.70(2)(e)1. 1. The dairy plant operator collects the test sample according to a uniform sampling schedule that the operator applies to all milk producers who ship milk to the operator’s dairy plant.