Chapter ATCP 65

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.

ATCP 65.70(2)(e)2. 2. The dairy plant operator reports the test result according to standard reporting criteria that the operator applies to all milk producers who ship milk to the dairy plant operator’s dairy plant.

ATCP 65.70(2)(f) (f) Immediate response level; reporting and follow-up. If a bacterial count under this section or s. ATCP 65.76 exceeds 750,000 per ml., the dairy plant operator shall do all the following:

ATCP 65.70(2)(f)1. 1. Report the test result to the division and the milk producer within 3 business days after the operator obtains the test result.

ATCP 65.70(2)(f)2. 2. Perform a confirmatory bacteriological test on at least one more sample of milk collected from the milk producer’s dairy farm. The dairy plant operator shall collect the confirmatory sample within 14 days after the date on which the dairy plant operator collected the original sample. The dairy plant operator shall report the confirmatory test result to the division and the milk producer within 3 business days after the operator obtains the test result.

ATCP 65.70(2)(f)3. 3. Reject milk shipments from the dairy farm if the confirmatory test shows a bacterial count in excess of 750,000 per ml. The milk producer may not ship milk from the dairy farm to any dairy plant until a dairy plant operator conducts another test and finds that milk from the farm has a bacterial count not more than 750,000 per ml.

ATCP 65.70(2)(g) (g) Division inspection; reinspection fee. The division may inspect a dairy farm in response to any bacterial count reported to the division under this section. If the division inspects a dairy farm in response to a confirmatory bacterial count of more than 750,000 per ml. under par. (f), the division shall charge a reinspection fee under s. ATCP 65.02 (19). The division may not charge a reinspection fee if the confirmatory bacterial count does not exceed 750,000 per ml., or if the division inspects more than 3 weeks after the division receives the confirmatory bacterial count.

ATCP 65.70 Note Note: Under s. ATCP 65.920 the department will suspend a producer’s grade A farm permit if 3 of the last 5 bacterial counts reported to the department under this section exceed the grade A standard of 100,000 per ml. under s. ATCP 65.70 (2). The department will suspend the producer’s grade A permit regardless of whether any bacterial count exceeds the immediate response level of 750,000 per ml. under this section.

ATCP 65.70 Note Note: Under s. ATCP 65.920 the department may suspend a milk producer’s license if bacterial counts continue to exceed the grade B standard of 300,000 per ml. under s. ATCP 65.70 (2). The department may suspend the producer’s license regardless of whether any bacterial count exceeds the immediate response level of 750,000 per ml. under this section. If 2 of the last 4 bacterial counts reported to the department under this section exceed the grade B standard of 300,000 per ml., the department will, at a minimum, send a warning notice to the producer.

ATCP 65.70(2)(h) (h) Laboratory reporting. A laboratory that performs tests under this section for a dairy plant operator may report the test results for the dairy plant operator.

ATCP 65.70(2)(i) (i) Electronic reporting. A dairy plant operator or laboratory shall report test results under this section in an electronic form approved by the division.

ATCP 65.70(3) (3) Drug residues. The milk shall not contain any drug residue. A dairy plant operator or milk contractor licensed as a dairy plant shall test each load of milk received from each milk producer for drug residues in accordance with s. ATCP 65.72.

ATCP 65.70(4) (4) Somatic cell count.

ATCP 65.70(4)(a) (a) Limits. The somatic cell count of cow or sheep milk, as determined by a direct microscopic somatic cell count, an electronic somatic cell count, or other method approved by the division under this subchapter, shall not exceed 750,000 cells per ml. The somatic cell count of goat milk, as determined by the Pyronin Y Methyl green stain test, shall not exceed 1,500,000 cells per ml. Except as provided under par. (g), a dairy plant is not required to reject milk shipments in response to a violation of this subsection unless the department 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(4)(b) (b) Monthly Testing Required. During every 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 perform at least one somatic cell count on a milk sample obtained from the producer under s. ATCP 82.12. If the dairy plant operator tests more than one milk sample each month, the dairy plant operator shall collect the samples at regular intervals throughout the month. A dairy plant operator shall perform tests under this subsection and s. ATCP 65.76 on the same milk samples.

ATCP 65.70 Note Note: Somatic cell tests must be performed using methods prescribed under s. ATCP 65.78 (3). The maximum time between sample collection and testing depends on the test method used.

ATCP 65.70(4)(c) (c) New milk producer; initial testing. A dairy plant operator or milk contractor licensed as a dairy plant shall perform a somatic cell count on a milk sample collected from the milk shipment received from a milk producer. The operator shall report the test result to the division and the producer within 7 days after the operator obtains the test result.

ATCP 65.70(4)(d) (d) Test methods. A somatic cell count under this subsection shall be a direct microscopic somatic cell count or an electronic somatic cell count. If the somatic cell count on goat milk exceeds 1,500,000 per ml., the somatic cell count shall be confirmed using the Pyronin Y Methyl green stain test, unless that test was used to obtain the initial count.

ATCP 65.70(4)(e) (e) Monthly reporting. For each month in which a dairy plant operator or milk contractor licensed as a dairy plant receives milk shipments from a milk producer, the dairy plant operator shall report to the division and the producer at least one representative somatic cell count under sub. (4) for a milk shipment procured in that month. The dairy plant operator shall report the somatic cell count within 7 days after the dairy plant operator obtains the count.

ATCP 65.70(4)(f) (f) Representative somatic cell counts. A somatic cell count is not representative, for reporting purposes under sub. (4), unless all the following apply:

ATCP 65.70(4)(f)1. 1. The dairy plant operator collects the test sample according to a uniform sampling schedule that the dairy plant operator applies to all milk producers who ship milk to the same dairy plant.

ATCP 65.70(4)(f)2. 2. The dairy plant operator reports the somatic cell count according to standard reporting criteria that the dairy plant operator applies to all milk producers who ship milk to the same dairy plant.

ATCP 65.70(4)(g) (g) Immediate response level; reporting and follow-up. If a somatic cell count under this section exceeds 1,000,000 per ml. for cow or sheep milk, the dairy plant operator shall do all the following:

ATCP 65.70(4)(g)1. 1. Report the somatic cell count to the division and the milk producer within 3 business days after the operator obtains the somatic cell count.

ATCP 65.70(4)(g)2. 2. Perform a confirmatory somatic cell count on at least one more sample of milk collected from the milk producer’s dairy farm. The dairy plant operator shall collect the confirmatory sample within 14 days after the date on which the operator collected the original sample. The dairy plant operator shall report the confirmatory somatic cell count to the division and the milk producer within 3 business days after the dairy plant operator obtains the confirmatory count.

ATCP 65.70(4)(g)3. 3. Reject milk shipments from the dairy farm if the confirmatory somatic cell count under par. (2) still exceeds 1,000,000 per ml. The milk producer may not ship cow or sheep milk from the dairy farm to any dairy plant until a dairy plant operator conducts another somatic cell count and finds that the count no longer exceeds this number.

ATCP 65.70 Note Note: The department will suspend a grade A farm permit if 3 of the last 5 reported somatic cell counts exceed the standard under s. ATCP 65.70 (4), regardless of whether any somatic cell count exceeds the immediate response level under this subsection. See s. ATCP 65.920.

ATCP 65.70 Note Note: Under s. ATCP 65.920, the department may suspend a milk producer license if somatic cell counts continue to exceed the standard under s. ATCP 65.70 (4), regardless of whether any somatic cell count exceeds the immediate response level under this subsection. If 2 of the last 4 reported somatic cell counts exceed the standard under s. ATCP 65.70 (4), the department will at least send a warning notice to the producer. See s. ATCP 65.920.

ATCP 65.70(4)(h) (h) Laboratory reporting. A laboratory that performs somatic cell counts under this subsection for a dairy plant operator may report the somatic cell counts for the dairy plant operator.

ATCP 65.70(5) (5) Temperature. The temperature of milk received or collected from a dairy farm more than 2 hours after the most recent milking shall not exceed 45° F. (7° C.), or 50° F. (10° C.) in the case of grade B milk in cans. The temperature of blended milk, consisting of milk from 2 or more milkings, that was received or collected less than 2 hours after the most recent milking shall not exceed 45° F. (7° C.)

ATCP 65.70(6) (6) Pesticides and toxic substances. The milk shall be free of pesticides and toxic substances.

ATCP 65.70 History History: CR 14-073: cr. Register August 2016 No. 728, eff. 9-1-16; correction in (4) made under s. 35.17, Stats., Register August 2016 No. 728.

ATCP 65.72 ATCP 65.72 Drug residue testing.

ATCP 65.72(1) (1) Monthly testing of producer milk shipments. During every month in which a dairy plant or milk contractor licensed as a dairy plant receives milk from a milk producer, the dairy plant operator shall perform a drug residue test on a milk sample obtained from that producer under s. ATCP 82.12. The drug residue test shall be sensitive, at a minimum, to beta lactam drug residues.

ATCP 65.72(2) (2) New milk producer; initial testing. A dairy plant operator or milk contractor licensed as a dairy plant shall perform a drug residue test on a milk sample collected from the first milk shipment received from a milk producer. The drug residue test shall be sensitive, at a minimum, to beta lactam drug residues and any other drug residues for which testing is required under sub. (3) (b) If the sample tests positive for any drug residue, the dairy plant operator shall report the result to the division and the producer within the time prescribed in sub. (9).

ATCP 65.72(3) (3) Testing bulk loads.

ATCP 65.72(3)(a) (a) Beta lactam drug residues; routine bulk load testing. Every dairy plant operator shall perform a drug residue test on every bulk load of raw milk offered for sale upon delivery at that dairy plant. The drug residue test shall be approved by the division and detect, at a minimum, beta lactam drug residues.

ATCP 65.72(3)(b) (b) Other drug residues; random bulk load testing.

ATCP 65.72(3)(b)1. 1. In addition to performing routine beta lactam tests under par. (a), the operator of a dairy plant shall randomly test bulk milk deliveries received at that dairy plant for other drug residues whenever random testing is required by the division under subd. 2. The random testing program shall be designed so that, during any consecutive 6-month period, a milk shipment from each producer is included in at least 4 separate bulk load tests in each of 4 separate months.

ATCP 65.72(3)(b)2. 2. The division may issue a periodic written notice to dairy plant operators, requiring dairy plant operators to perform random tests under subd. 1. for drug residues specified in the division’s notice. The division shall issue the same notice to every dairy plant licensed by the department. The notice shall specify the effective date of the random testing requirements and the period of time during which the random testing requirements remain in effect.

ATCP 65.72(3)(b)3. 3. A dairy plant operator may test a bulk milk delivery to detect residues of one or more drugs for which the division has not required testing under subd. 2. The dairy plant shall follow the procedures in pars. (c), (d), and (e).

ATCP 65.72(3)(c) (c) Bulk load testing procedure. Whenever a dairy plant operator performs a drug residue test on a bulk load of milk under par. (a) or (b), the operator shall perform the test on a sample taken from the bulk milk tanker. Sufficient agitation or a milk sampling method approved by the division shall be used to ensure that the sample is representative of the contents of the tanker. The test shall be completed before the bulk load is commingled with any other producer’s milk and before any of the milk in the bulk load is processed. For testing purposes under pars. (a) and (b), a milk shipment received in cans is considered a bulk load.

ATCP 65.72(3)(d) (d) Responsibility for follow-up testing. If a bulk load of milk yields a confirmed positive test result for drug residue, and if the dairy plant receiving that milk from producers is not the dairy plant to which those producers are assigned for licensing purposes, under s. ATCP 65.02, the operator of the receiving dairy plant shall immediately notify the operator of the assigned dairy plant. The assigned dairy plant is responsible for performing follow-up tests on producer samples under sub. (4), and for rejecting producer shipments under sub. (5).

ATCP 65.72(3)(e) (e) Testing with an unapproved method. If the dairy plant uses a testing method that is not approved by the division and detects residues of one or more drugs for which the division has not required testing, under par. (b), that result shall be treated as a valid test result and reported to the division. The test result shall then either be confirmed under sub. (4) using a drug residue detection method approved by the division or the milk must be discarded under sub. (5). The dairy plant may recover the milk value, under sub. (6), if the confirmatory test result is obtained using a drug residue detection method approved by the division.

ATCP 65.72(3)(f) (f) Testing of frozen sheep milk for drug residues. A sheep milk producer intending to freeze the sheep milk before shipment must either sample or test the sheep milk for drug residues before bagging and freezing the sheep milk. The sample or test result must remain with the bag or bags of frozen sheep milk to which the sample or test result pertains. Each bag of frozen sheep milk shall be labeled to indicate the grade of milk, the dairy plant receiving the milk, the sheep milk producer, the total number of bags to which the sample or test result pertains, and the date on which the bag was filled with sheep milk. Sheep milk samples must be frozen within 24 hours of sampling, must be maintained at -15° C. (5° F.) or colder (documentation of storage temperature maintained) and must be tested with 60 days of sampling.

ATCP 65.72(4) (4) Drug residue found in bulk load; follow-up testing. If a bulk load of milk yields a confirmed positive test result for drug residue under sub. (3), the dairy plant operator shall perform a drug residue test on each of the individual milk producer samples collected for that bulk load under s. ATCP 82.12. The dairy plant operator shall test each milk producer’s sample before collecting any further milk from that producer. The drug residue test performed on each producer sample shall be sensitive to the same drug residue that was detected in the bulk load. If a milk producer’s sample tests positive for any drug residue, the dairy plant operator shall perform a confirmatory test using the same test method and sample. The dairy plant operator shall perform the confirmatory test in duplicate, with single positive and negative controls. If either confirmatory test result is positive for a drug residue, the milk producer’s sample is considered positive for that drug residue.