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WISCONSIN ADMINISTRATIVE CODE
AGRICULTURE, TRADE AND CONSUMER PROTECTION
CHAPTER ATCP 60 DAIRY FARMS
SUBCHAPTER IV -- MILK QUALITY STANDARDS; EXAMINATION OF MILK FROM DAIRY FARMS
Date:
08/31/2009
Document:
ATCP 60.19 Drug residue testing.
(1) TESTING PRODUCER MILK SHIPMENTS. (a) Monthly testing. During every month in which 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 60.17. The drug residue test shall be sensitive, at a minimum, to beta lactam drug residues.
(b) New milk producer; initial testing. A dairy plant operator shall perform a drug residue test on a milk sample collected from a milk producer's first milk shipment to that dairy plant operator. The drug residue test shall be sensitive, at a minimum, to beta lactam drug residues and other drug residues for which testing is required under sub. (2) (b). If the sample tests positive for any drug residue, the operator shall report the result to the department and the producer within the time prescribed in sub. (8).
(2) TESTING BULK LOADS. (a) Beta lactam drug residues; routine bulk load testing. The operator of every dairy plant shall perform a drug residue test on every bulk load of raw milk received at that dairy plant. The drug residue test shall be sensitive, at a minimum, to beta lactam drug residues.
(b) Other drug residues; random bulk load testing. 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 department 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.
2. The department 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 department's notice. The department 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.
(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. The test shall be completed before the bulk load is commingled with any other milk. For testing purposes under pars. (a) and (b), a milk shipment received in cans is considered a bulk load.
(d) Responsibility for follow-up testing. If a bulk load of milk tests positive 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 60.02, 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. (3), and for rejecting producer shipments under sub. (6).
(3) DRUG RESIDUE FOUND IN BULK LOAD; FOLLOW-UP TESTING. If a bulk load of milk tests positive for a drug residue under sub. (2), 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 60.17. The dairy plant operator shall test each producer 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 producer 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.
(4) DRUG RESIDUE FOUND IN BULK LOAD; LOAD REJECTED. If a bulk load of milk from one or more producers tests positive for a drug residue under sub. (2), the dairy plant operator shall reject the entire bulk load. Milk from a rejected bulk load may not be used for human food. The dairy plant operator shall denature or take responsibility for disposing of the rejected bulk load in a manner that precludes its use for human food.
(5) REJECTED BULK LOAD; DAIRY PLANT RECOVERY FROM PRODUCERS. (a) Dairy plant may recover loss. If a dairy plant operator properly rejects a bulk load of milk under sub. (4), the operator shall recover the value of that bulk load from producers whose milk samples, representing milk shipments contained in that bulk load, test positive for drug residue under sub. (3). The operator shall recover what would have been the value of the bulk load, had the load not tested positive for drug residue. The operator shall also recover any additional bulk load disposal, transportation and testing costs that the operator incurs because the bulk load tests positive for drug residues.
(b) Pro rata recovery. The dairy plant operator shall recover, from each offending producer under par. (a), a pro rata share of the total recovery amount under par. (a). The pro rata recovery from each offending producer shall be based on the size of that producer's shipment compared to those of other offending producers in the same bulk load. If there is only one offending producer, the operator shall recover the entire amount from that producer.
(c) Recovery deadline. The operator shall recover the full amount owed by each offending producer under par. (b) within 90 days after that producer's milk sample tests positive for drug residue under sub. (3). If the operator fails to recover the full amount within that time period, the operator shall give the department a written explanation.
(d) Payroll deduction. A dairy plant operator may deduct the amount owed by an offending producer under par. (b) from the operator's payroll obligation to that offending producer.
(e) Notice of deduction. A dairy plant operator shall give a producer at least 30 days prior written notice of any deduction under par. (d), unless the producer transfers to another dairy plant operator. The notice shall state all the following:
1. The basis for the deduction.
2. The total amount of the deduction.
3. The date on which the operator will make each deduction.
4. That the operator will meet with the producer to discuss the deduction, at the producer's request.
(f) Meeting to discuss recovery. A dairy plant operator shall meet with a producer, at the producer's request, to discuss the operator's recovery from that producer under this subsection. The operator shall meet with the producer within 10 days after the producer requests the meeting, unless the producer requests a later meeting date. If the producer contests the validity of the recovery, and the matter is not resolved, the operator shall notify the producer that the producer may request a hearing before the department under par. (g).
(g) Hearing request. If a producer contests the validity of a dairy plant operator's recovery under this subsection, and if the parties do not resolve the matter after meeting under par. (f), the producer may request a hearing before the department. A request for hearing does not automatically stay a recovery under this subsection.
(h) Informal hearing. If a producer requests a hearing under par. (g), the food safety division shall hold an informal hearing by telephone or at the division's nearest regional office. The division shall hold the informal hearing within 10 business days after the division receives the hearing request, unless the producer agrees to a later hearing date. The division shall include the producer and the dairy plant operator in the informal hearing.
(i) Formal hearing. If an informal hearing under par. (h) does not resolve the matter, a producer may request a contested case hearing before the department under ch. ATCP 1 and ch. 227, Stats. A request for hearing does not automatically stay a recovery under this subsection. If the department grants a producer's request for hearing, the department shall include the producer and the dairy plant operator as parties to the hearing.
(j) Invalid recovery. If the department finds that a dairy plant operator's recovery under this subsection is invalid, the department may prohibit the recovery or order the dairy plant operator to repay the producer. The food safety division may issue an order under this paragraph after the division holds an informal hearing under par. (h). If the division issues an order under this paragraph, the dairy plant operator may request a contested case hearing under ch. ATCP 1 and ch. 227, Stats., to contest the division's order. A request for hearing does not automatically stay the division's order.
(6) PRODUCER MILK SHIPMENTS REJECTED. (a) Dairy plant to reject. A dairy plant operator shall immediately notify a milk producer, and shall reject that producer's milk shipments as required under par. (b), if any of the following occurs:
1. A sample of the producer's milk under sub. (1) tests positive for a drug residue.
2. A sample of the producer's milk under sub. (3) tests positive for a drug residue.
3. A sample of the producer's milk tests positive for a 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.
(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 on the same or an equivalent test, at a laboratory that is certified under s. ATCP 77.03 (2) (c) to perform confirmatory tests.
(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:
1. Ship, collect or use that milk for human food.
2. Commingle that milk with milk from any other producer.
(d) Transfer between dairy plants. If a dairy plant operator rejects a producer's milk under par. (b), the milk producer may not ship milk to another dairy plant until a dairy plant operator tests that producer's milk and the milk tests negative for drug residues on the same or an equivalent test, at a laboratory that is certified under s. ATCP 77.03 (2) (c) to perform confirmatory tests.
(7) REPORTING DRUG RESIDUE FINDINGS; BULK LOADS. Within 2 hours after a bulk load of milk tests positive for a drug residue under sub. (2), the dairy plant operator shall report the drug test result to the food safety division by telephone or facsimile (FAX) transmission. The dairy plant operator shall confirm the report in writing, in a form approved by the department, 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.
(8) REPORTING DRUG RESIDUE FINDINGS; PRODUCER MILK SHIPMENTS. (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 department under par. (b):
1. A milk producer sample under sub. (1) tests positive for a drug residue.
2. A milk producer sample under sub. (3) tests positive for a drug residue.
3. A sample of a producer's milk tests positive for a 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.
(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 food safety division by telephone or facsimile (FAX) transmission. The dairy plant operator shall make the report within 2 hours after the drug residue test is completed. The operator shall confirm the report in writing, in a form approved by the department, within 3 business days after the drug residue test is completed.
(9) INSPECTION BY DEPARTMENT; REINSPECTION FEE. The department may, in its discretion, inspect a dairy farm in response to any positive drug residue test report under sub. (8). The department shall charge a reinspection fee for the inspection under s. ATCP 60.04. The department 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 department.
(10) DRUG RESIDUE TEST RESULTS. (a) Positive test result; general. For purposes of this section and s. ATCP 60.275, 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.
(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:
Drug Action Level (ppb)
Ampicillin 10
Amoxicillin 10
Cephapirin 20
Ceftiofur 100
Cloxacillin 10
Neomycin 150
Novobiocin 100
Penicillin G 5
Sulfadimethoxine 10
Tylosin 50
Erythromycin* 50
Gentamicin* 30
Dihydrostreptomycin* 125
Sulfachloropyridazine* 10
Sulfadiazine* 10
Sulfamerazine* 10
Sulfamethazine* 10
Sulfamethizole* 10
Sulfanilamide* 10
Sulfapyridine* 10
Sulfaquinoxaline* 10
Sulfathiazole* 10
Tetracyclines* 300
Note: Action levels specified under this paragraph are based on tolerances or "safe 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.
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. They do not legalize residues found in milk that are below the "safe level." "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.
(c) Test result presumed valid. For purposes of this section and s. ATCP 60.275, whenever a dairy plant operator reports a positive test result to the department under sub. (8), that test result is rebuttably presumed to be valid.
(11) 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.
(12) 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.
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 milk hauler collects milk from the first farm. Confirmation of positive drug residue screening tests, if required under s. ATCP 60.22 (1) (b) 3., must be completed within the same 72-hour period.
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