Chapter ATCP 65

ATCP 65.72(7) (7) Producer milk shipments rejected.

ATCP 65.72(7)(a) (a) Dairy plant to reject. A dairy plant operator shall immediately notify a milk producer directly, or via the milk contractor from whom the producer’s milk was procured, and shall reject that producer’s milk shipments as required under par. (b), if any of the following occurs:

ATCP 65.72(7)(a)1. 1. A sample of the producer’s milk, under sub. (1), yields a confirmed positive test result for drug residue.

ATCP 65.72(7)(a)2. 2. A sample of the producer’s milk, under sub. (4), yields a confirmed positive test result for drug residue.

ATCP 65.72(7)(a)3. 3. A sample of the producer’s milk yields a confirmed positive test result for drug residue after that milk has been commingled with milk from other producers, regardless of whether the drug residue test is required under this chapter.

ATCP 65.72(7)(b) (b) Producer milk rejected. If a dairy plant operator is required to reject producer milk shipments under par. (a), the dairy plant operator shall reject all milk produced on that dairy farm until a sample of that milk tests negative for drug residues by the same or an equivalent test at a laboratory that is certified under s. ATCP 77.03 (2) (c) to perform confirmatory tests.

ATCP 65.72(7)(c) (c) Rejected milk; use prohibited. If a dairy plant operator rejects a producer’s milk under par. (b), no person may do any of the following:

ATCP 65.72(7)(c)1. 1. Ship, collect, or use that milk for human food.

ATCP 65.72(7)(c)2. 2. Commingle that milk with milk from any other producer.

ATCP 65.72(7)(d) (d) Transfer between dairy plants. If a dairy plant operator rejects a producer’s milk under par. (b), the milk producer or a milk contractor may not ship that producer’s milk to another dairy plant until a dairy plant operator tests that producer’s milk and the milk tests negative for drug residue on the same or an equivalent test at a laboratory that is certified under s. ATCP 77.03 (2) (c) to perform confirmatory tests.

ATCP 65.72(8) (8) Reporting drug residue findings; bulk loads. Within 2 hours after a bulk load of milk yields a confirmed positive test result for drug residue under sub. (2), the dairy plant operator shall report the drug test result to the division by telephone, electronic mail, or facsimile (FAX) transmission. The dairy plant operator shall confirm the report in writing, in a form approved by the division, within 3 business days after the drug residue test is completed. The report shall indicate the result of the drug residue test, the volume of milk contained in the bulk load, and the dairy plant’s disposition of that milk.

ATCP 65.72(9) (9) Reporting drug residue findings; producer milk shipments.

ATCP 65.72(9)(a) (a) Dairy plant to report. Whenever any of the following occurs, the dairy plant operator that performs the drug residue test shall report the test result to the division under par. (b):

ATCP 65.72(9)(a)1. 1. A milk producer sample, under sub. (1), yields a confirmed positive test result for drug residue.

ATCP 65.72(9)(a)2. 2. A milk producer sample, under sub. (4), yields a confirmed positive test result for drug residue.

ATCP 65.72(9)(a)3. 3. A sample of a producer’s milk yields a confirmed positive test result for drug residue after that milk has been commingled with milk from other producers, regardless of whether the drug residue test is required under this chapter.

ATCP 65.72(9)(b) (b) Form of report. Whenever a dairy plant operator is required to report a drug residue test result under par. (a), the dairy plant operator shall report that result to the division by telephone, electronic mail, or facsimile (FAX) transmission. The dairy plant operator shall make the report within 2 hours after the drug residue test is completed. The dairy plant operator shall confirm the report in writing, on a form approved by the division, within 3 business days after the drug residue test is completed.

ATCP 65.72(10) (10) Inspection by division; reinspection fee. The division may, in its discretion, inspect a dairy farm in response to any positive drug residue test report under sub. (8) or (9). The division shall charge a reinspection fee for the inspection under s. ATCP 65.02 (19). The division shall not charge a reinspection fee if it makes its inspection more than 3 weeks after the dairy plant operator reports the drug residue test result to the division.

ATCP 65.72(11) (11) Drug residue test results.

ATCP 65.72(11)(a) (a) Positive test result; general. For purposes of this section and s. ATCP 65.922, a drug residue test is considered positive if the detected amount of drug residue exceeds the action level specified for that drug under par. (b). The action levels, under par. (b), do not establish legal tolerances for drug residues in milk, nor do they preclude the department from taking enforcement action where drug residues are present at levels below these action levels.

ATCP 65.72(11)(b) (b) Specified drug tests; positive test result. In a test for any of the following drugs, the action level is exceeded whenever the drug residue level found in the test exceeds the level specified below:

ATCP 65.72(11)(b)1. 1. Ampicillin 10 ppb

ATCP 65.72(11)(b)2. 2. Amoxicillin 10 ppb

ATCP 65.72(11)(b)3. 3. Cephapirin 20 ppb

ATCP 65.72(11)(b)4. 4. Ceftiofur 100 ppb

ATCP 65.72(11)(b)5. 5. Cloxacillin 10 ppb

ATCP 65.72(11)(b)6. 6. Novobiocin 100 ppb

ATCP 65.72(11)(b)7. 7. Penicillin G 5 ppb

ATCP 65.72(11)(b)8. 8. Sulfadimethoxine 10 ppb

ATCP 65.72(11)(b)9. 9. Tetracyclines* 300 ppb

ATCP 65.72 Note Note: Action levels specified under this paragraph are based on tolerances and/or target testing levels specified by the United States food and drug administration, and identified in a memorandum from FDA’s Milk Safety Branch, M-I-05-5, September 27, 2005. A copy of the memorandum is on file with the department, and is available upon request.

ATCP 65.72 Note For drugs identified with an asterisk (*), the levels in this paragraph are based on “safe levels” specified by FDA. ”Safe levels” are merely enforcement guides and do not constitute legal tolerances. ”Safe levels” are not binding on the courts or the department. They do not limit the department’s discretion in any way, and they do not protect milk producers or milk itself from enforcement action. “Safe levels” do not constitute animal drug tolerances under section 512 (b) of the federal food, drug and cosmetic act.

ATCP 65.72(11)(c) (c) Test result presumed valid. For purposes of this section and s. ATCP 65.922, whenever a dairy plant operator reports a confirmed positive test result to the division under sub. (9), that test result is presumed to be valid. The milk producer may appeal the test result in an informal hearing under s. ATCP 65.928.

ATCP 65.72(12) (12) 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 65.72(13) (13) Timely testing. Drug residue tests required under this section shall be completed within 72 hours after the tested milk, or any portion of the tested milk, was first collected from a dairy farm.

ATCP 65.72 Note Note: If a drug residue test is performed on a bulk load of milk collected from several dairy farms, the test must be completed within 72 hours after the bulk milk weigher and sampler collects milk from the first farm. Confirmation of positive drug residue screening tests, at a different laboratory than the laboratory which performed the screening tests, as required under s. ATCP 65.72 (3), must be completed within the same 72-hour period.

ATCP 65.72 History History: CR 14-073: cr. Register August 2016 No. 728, eff. 9-1-16; correction in (3) (e) made under s. 35.17, Stats., Register August 2016 No. 728.

ATCP 65.74 ATCP 65.74 Milk and dairy products; quality standards.

ATCP 65.74(1) (1) Milk held at dairy plant; bacterial count. The bacterial count of commingled grade A milk held at a dairy plant before pasteurization may not exceed 300,000 per ml. The bacterial count of grade B milk held at a dairy plant before pasteurization or processing may not exceed 750,000 per ml.

ATCP 65.74(2) (2) Pasteurized grade A dairy products.

ATCP 65.74(2)(a) (a) Bacterial counts in pasteurized grade A dairy products other than cultured dairy products may not exceed the following levels:

ATCP 65.74(2)(a)1. 1. 20,000 per ml., except as provided in subd. 2. and 3.

ATCP 65.74(2)(a)2. 2. 10,000 per g. for nonfat dry milk.

ATCP 65.74(2)(a)3. 3. 30,000 per ml. for condensed milk, whey, whey products, and dried whey.

ATCP 65.74(2)(b) (b) Coliform counts in pasteurized grade A dairy products may not exceed 10 per ml. or per gram, except that coliform counts in bulk milk tanker shipments of pasteurized grade A dairy products may not exceed 100 per ml.

ATCP 65.74(2)(c) (c) In pasteurized grade A milk without added flavors or ingredients, other than vitamins, there shall be fewer than 350 milliunits of phosphatase per liter as determined by the Fluorophos ALP method, the Charm Paslite Alkaline Phosphatase method or another test method approved by the department.

ATCP 65.74(2)(d) (d) The yeast and mold count of pasteurized cottage cheese may not exceed 10 per gram.

ATCP 65.74(3) (3) Pasteurized grade b dairy products.

ATCP 65.74(3)(a) (a) Bacterial counts in pasteurized grade B dairy products, other than cultured dairy products or frozen desserts containing nuts or other inclusions, may not exceed the following levels:

ATCP 65.74(3)(a)1. 1. 20,000 per ml., except as provided in subd. 2. or 3.

ATCP 65.74(3)(a)2. 2. 30,000 per ml. for condensed milk, whey, whey products, dried whey, and nonfat dry milk.

ATCP 65.74(3)(a)3. 3. 50,000 per gram for frozen desserts, except that the bacterial count for frozen-dessert mixes may not exceed 20,000 per gram.

ATCP 65.74(3)(b) (b) Coliform counts in pasteurized grade B dairy products, other than grade B dairy products made with natural or added cultures and all natural cheeses, may not exceed 10 per ml. or per gram, except that coliform counts in bulk milk tanker shipments may not exceed 100 per ml.

ATCP 65.74(4) (4) Fortified dairy products. Whenever milk or a fluid milk product is fortified with vitamin A or D the fortification shall comply with Appendix O of the PMO.

ATCP 65.74(5) (5) Pathogen confirmed in ready-to-eat dairy product; sale prohibited. A dairy plant operator may not sell or distribute any ready-to-eat dairy product in which a microbiological test or laboratory analysis has confirmed the presence of a pathogenic organism or toxin. Results of the microbiological test or laboratory test shall be reported to the division, under s. ATCP 65.46 (2).

ATCP 65.74 Note Note: Copies of PMO Appendix O are on file with the department and the legislative reference bureau. Copies may be obtained from the department at cost or online at:www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Milk.

ATCP 65.74 History History: CR 14-073: cr. Register August 2016 No. 728, eff. 9-1-16.

ATCP 65.76 ATCP 65.76 Milk quality testing.

ATCP 65.76(1) (1) Required testing.

ATCP 65.76(1)(a) (a) A dairy plant operator shall test raw milk from dairy farms as required under this chapter.

ATCP 65.76(1)(b) (b) A dairy plant operator shall test milk and dairy products held or processed at a dairy plant for compliance with standards specified under s. ATCP 65.74 (1) to (4). The dairy plant operator shall test the milk and dairy products as often as necessary to provide reasonable statistical assurance of compliance.

ATCP 65.76(2) (2) Laboratory.

ATCP 65.76(2)(a) (a) Except as provided under par. (b), milk quality tests required under this chapter shall be performed in a laboratory that is all of the following:

ATCP 65.76(2)(a)1. 1. Approved by the department to conduct milk quality tests.

ATCP 65.76(2)(a)2. 2. Certified by the department under s. ATCP 77.03, or by an equivalent certifying agency in another state, to conduct milk quality tests.

ATCP 65.76(2)(b) (b) A laboratory that is not certified under s. ATCP 77.03 to perform a drug residue test under s. ATCP 65.72 may perform that test as a screening test if all of the following apply:

ATCP 65.76(2)(b)1. 1. The department has approved that laboratory to perform that screening test under s. ATCP 77.23 (1).

ATCP 65.76(2)(b)2. 2. The department has approved the person who performs the screening test under s. ATCP 77.23 (2).

ATCP 65.76(2)(b)3. 3. A different laboratory performs a confirmatory test if the screening test result is positive for drug residue. The laboratory performing the confirmatory test shall be certified to do so under s. ATCP 77.03. The laboratory shall perform the confirmatory test on the same test sample using the same or an equivalent test method and shall complete the confirmatory test within the time period specified in s. ATCP 65.72 (8).

ATCP 65.76(2)(c) (c) The department may withdraw its approval under par. (a) or (b) for cause, including false or inaccurate test results or reports, or failure to conduct tests according to required procedures.

ATCP 65.76(3) (3) Analysts.

ATCP 65.76(3)(a) (a) Except as provided in par. (b) or (c), no individual may perform a milk test under ss. ATCP 65.70 and 65.72 unless the department has certified that individual under s. ATCP 77.22 to perform that test.

ATCP 65.76(3)(b) (b) Pursuant to s. ATCP 77.23 (2), the department may approve an individual to perform a drug residue test under s. ATCP 65.72 as a screening test, even though the individual is not certified under s. ATCP 77.22 to perform that test as a confirmatory test.

ATCP 65.76(3)(c) (c) Bulk load tests for drug residues under s. ATCP 65.72 shall be conducted at the receiving dairy plant by any of the following:

ATCP 65.76(3)(c)1. 1. An individual approved by the department to conduct drug residue tests.

ATCP 65.76(3)(c)2. 2. An individual who performs drug residue tests only under the direct supervision of an individual approved and certified under subd. 1.

ATCP 65.76 Note Note: A laboratory performing milk quality tests must be certified under ch. ATCP 77.

ATCP 65.76(4) (4) Test methods. Milk testing under ss. ATCP 65.70 and 65.72 shall use test methods prescribed in the applicable FDA 2400 series laboratory evaluation forms, published by the United States department of health and human services, public health service, food and drug administration, that are in effect on February 1, 2008. If no FDA form applies, testing shall be conducted according to methods prescribed in the ”Standard Methods for the Examination of Dairy Products,” 17th Edition (2004), or in ”Official Methods of Analysis of AOAC International,” 18th Edition (2005).

ATCP 65.76 Note Note: Copies of the FDA 2400 series laboratory evaluation forms in effect on February 1, 2008, are on file with the department and the legislative reference bureau. To find out how to obtain a copy of these forms, you may contact the department at the following address:

ATCP 65.76 Note Wisconsin Department of Agriculture, Trade and Consumer Protection

ATCP 65.76 Note Division of Food Safety

ATCP 65.76 Note Laboratory Certification Program

ATCP 65.76 Note P.O. Box 8911, Madison, WI 53708-8911

ATCP 65.76 Note Telephone: [phone]

ATCP 65.76 Note The American Public Health Association’s “Standard Methods for the Examination of Dairy Products,” 17th Edition (2004), is on file with the department and the legislative reference bureau and may be obtained from the American Public Health Association, Inc., 800 I Street, NW, Washington, D.C. 20001, telephone [phone], website www.apha.org.

ATCP 65.76 Note The “Official Methods of Analysis of AOAC International,” 18th Edition (2005), is on file with the department and the legislative reference bureau and may be obtained from AOAC International, 2275 Research Blvd., Rockville, MD 20850, telephone [phone], website https://www.aoac.org .

ATCP 65.76(5) (5) Bacteria counts. Bacteria counts required under s. ATCP 65.70 and bacteria counts that may affect the amount paid to a milk producer shall be obtained by means of a standard plate count, plate loop count, or petrifilm aerobic count method.

ATCP 65.76(6) (6) Drug residues. Drug residue tests required under s. ATCP 65.72 shall be performed according to s. ATCP 65.72.

ATCP 65.76(7) (7) Somatic cells. Somatic cell counts required under s. ATCP 65.70 (4) and somatic cell counts that may affect the amount paid to a milk producer shall be obtained by means of a direct microscopic somatic cell count or an electronic somatic cell count. The Pyronin Y-Methyl green stain test may be used in place of a direct microscopic somatic cell count or electronic somatic cell count for goat milk and shall be used to confirm a direct microscopic somatic cell count or electronic somatic cell count on goat milk that exceeds 1,000,000 per ml.