Section 65.72. Drug residue testing.

 

(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.

(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) .

(3)   Testing bulk loads.

(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.

(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 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.

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.

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) .

(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.

(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) .

(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.

(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.

(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.

(5)   Drug residue found in bulk load; load rejected. If a bulk load of milk from one or more milk producers yields a confirmed positive test result for drug residue under sub. (3) , 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.

(6)   Rejected bulk load; dairy plant recovery from producers or milk contractors.

(a) Dairy plant loss recovery. If a dairy plant operator properly rejects a bulk load of milk under sub. (5) , the dairy plant operator may recover the value of that bulk load from producers whose milk samples, representing milk shipments contained in that bulk load, yield a confirmed positive test result for drug residue under sub. (4) . If the milk has been procured by the dairy plant from a milk contractor, the dairy plant operator may recover the value of that bulk load from the milk contractor, who may then recover the value of that bulk load from the milk producers. The dairy plant operator may recover what would have been the value of the bulk load, had the load not yielded a confirmed positive test result for drug residue. The dairy plant operator shall also recover any additional bulk load disposal, transportation, and testing costs that the dairy plant operator incurs because the bulk load yielded a confirmed positive test result for drug residue.

(b) Pro rata recovery. The dairy plant operator, or milk contractor, if recovering milk costs under par. (a) , shall recover, from each producer identified in par. (a) , a pro rata share of the total recovery amount under par. (a) . The pro rata recovery from each producer shall be based on the size of that producer's shipment compared to those of any other producers in the same bulk load. If there is only one producer identified in par. (a) , the operator shall recover the entire amount from that producer.

(c) Recovery deadline. The dairy plant operator or milk contractor shall recover the full amount owed by each offending milk producer, under par. (b) , within 90 days after that producer's milk sample yields a confirmed positive test result for drug residue under sub. (3) . If the dairy plant operator or milk contractor fails to recover the full amount within that time period, the dairy plant operator shall give the department a written explanation.

(d) Payroll deduction. A dairy plant operator or milk contractor may deduct the amount owed by an offending milk producer, under par. (b) , from the dairy plant operator's payroll obligation to that offending milk producer.

(e) Notice of deduction. A dairy plant operator or milk contractor shall give a milk producer at least 30 days prior written notice of any deduction, under par. (d) , unless the milk 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 dairy plant operator or milk contractor will make each deduction.

4. That the dairy plant operator or milk contractor will meet with the milk producer to discuss the deduction, at the milk producer's request.

(f) Meeting to discuss recovery. A dairy plant operator or milk contractor shall meet with a milk producer, at the milk producer's request, to discuss the recovery from that milk producer under this subsection. The dairy plant operator or milk contractor shall meet with the milk producer within 10 days after the milk producer requests the meeting, unless the milk producer requests a later meeting date. If the milk producer contests the validity of the recovery, and the matter is not resolved, the dairy plant operator or milk contractor shall notify the milk producer that the milk producer may request a hearing before the department under par. (g) .

(g) Hearing request. If a milk producer contests the validity of a 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 division. A request for hearing does not automatically stay a recovery under this subsection.

(h) Informal hearing. If a milk producer requests a hearing under par. (g) , the division shall hold an informal hearing by telephone or at the division's nearest office. The division shall hold the informal hearing within 20 days after the division receives the hearing request, unless the milk producer agrees to a later hearing date. The division shall include the producer and the dairy plant operator or milk contractor in the informal hearing.

(i) Formal hearing. If an informal hearing, under par. (h) , does not resolve the matter, a milk 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 milk producer's request for hearing, the department shall include the milk producer and the dairy plant operator or milk contractor as parties to the hearing.

(j) Invalid recovery. If the department finds that a recovery under this subsection is invalid, the department may prohibit the recovery or order the dairy plant operator or milk contractor to repay the producer. The 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.

(7)   Producer milk shipments rejected.

(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:

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

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

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.

(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.

(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 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.

(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.

(9)   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 division under par. (b) :

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

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

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.

(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.

(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.

(11)   Drug residue test results.

(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.

(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:

1. Ampicillin 10 ppb

2. Amoxicillin 10 ppb

3. Cephapirin 20 ppb

4. Ceftiofur 100 ppb

5. Cloxacillin 10 ppb

6. Novobiocin 100 ppb

7. Penicillin G 5 ppb

8. Sulfadimethoxine 10 ppb

9. Tetracyclines* 300 ppb

(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 .

(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.

(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.

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 .

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. Microsoft Windows NT 6.1.7601 Service Pack 1 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. Microsoft Windows NT 6.1.7601 Service Pack 1 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. Microsoft Windows NT 6.1.7601 Service Pack 1