§ 59a.111. Drug residue level.
(a) Industry responsibilities. Manufactured dairy products permitholders shall meet the requirements of this section to confirm their manufactured dairy products are free of violative drug residues.
(1) Sampling and testing program.
(i) Milk shipped for processing or intended to be processed on the farm where it was produced shall be sampled and tested, prior to processing, for beta lactam drug residue. Collection, handling and testing of samples shall be done according to procedures established by the Department in this section, and in accordance with Appendix N of the Grade ‘‘A’’ PMO, regarding drug residue testing and farm surveillance. If a person processes milk on the farm where it was produced and produces that milk in accordance with a written quality control program addressing the use of animal drugs at that dairy operation, that person may request a variance from the testing requirements of this subparagraph. The request shall be in writing and include a copy of the written quality control program. The Department may, on the basis of the request, issue a variance with respect to the requirements of this subparagraph. A variance issued under this subparagraph will be valid for no more than 1 year and may be renewed for additional periods of up to 1 year following the Department’s review of the quality control program and any on-farm inspections the Department deems necessary to determine whether a successor variance should be issued.
(ii) When so specified by the FDA, milk shipped for processing, or intended to be processed on the farm where it was produced, shall be sampled and tested, prior to processing, for other drug residues under a random drug sampling program. The random drug sampling program must include at least four samples collected in at least 4 separate months during any consecutive 6-month period.
(iii) When the Commissioner of the FDA determines that a potential problem exists with an animal drug residue or other contaminant in the milk supply, a sampling and testing program shall be conducted, as determined by the FDA. The testing shall continue until the Commissioner of the FDA determines with reasonable assurance that the potential problem has been remedied.
(iv) The dairy industry shall analyze samples for beta lactams and other drug residues by methods which have been independently evaluated or evaluated by the FDA and accepted by the FDA as effective to detect drug residues at current safe or tolerance levels. Safe and tolerance levels for particular drugs are established by the FDA.
(v) Sample test results for milk that does not test positive shall be recorded. The test result records shall be retained for 6 months.
(2) Individual producer sampling.
(i) Bulk milk. A milk sample for beta lactam drug residue testing shall be taken at each farm and include milk from each farm bulk tank. The sample shall be tested for beta lactam drug residues on the same monthly schedule as the bacterial estimate testing described in § 59a.109 (relating to bacterial estimate classification).
(ii) Can milk. A milk sample for beta lactam drug residue testing shall be formed separately at the receiving plant for each can milk producer included in a delivery, and shall be representative of all milk received from the producer. The sample shall be tested for beta lactam drug residues on the same monthly schedule as the bacterial estimate testing described in § 59a.109.
(iii) Producer/processor. A milk sample for beta lactam drug residue testing shall be formed separately according to subparagraphs (i) and (ii) for milk produced or received by a producer/processor. The sample shall be tested for beta lactam drug residues on the same monthly schedule as the bacterial estimate testing described in § 59a.109.
(3) Load sampling and testing.
(i) Bulk milk. A load sample shall be taken from the bulk milk pickup tanker and tested for beta lactam residues after its arrival at the plant and prior to further commingling.
(ii) Can milk. A load sample representing all of the milk received on a shipment shall be formed at the plant using a sampling procedure that includes milk from every can on the vehicle and tested for beta lactam residues.
(iii) Producer/processor. A daily load sample shall be formed at the plant using a sampling procedure that includes all milk produced and received at the plant that day and tested for beta lactam residues.
(4) Sample and record retention. A load sample that tests positive for drug residue shall be retained for at least 12 months. The records of all positive sample test results shall be retained for at least 24 months.
(5) Industry follow-up.
(i) When a load sample tests positive for drug residue, an employee or representative of the receiving plant shall notify the Department immediately of the positive test result and of the intended disposition of the shipment of milk containing the drug residue. Milk testing positive for drug residue shall be disposed of in a manner that removes it from the human or animal food chain, except when acceptably reconditioned under FDA compliance policy guidelines.
(ii) Each individual producer sample represented in the positive-testing load sample shall be individually tested as directed by the Department to determine the producer of the milk sample testing positive for drug residue. Identification of the producer responsible for producing the milk testing positive for drug residue, and details of the final disposition of the shipment of milk containing the drug residue, shall be reported immediately to the Department.
(iii) Milk shipment from the producer identified as the source of milk testing positive for drug residue shall cease immediately and may resume only after a sample from a subsequent milking does not test positive for drug residue.
(b) Responsibilities of the Department.
(1) Monitoring and surveillance. The Department will monitor the milk industry’s drug residue program by conducting unannounced onsite inspections to observe testing and sampling procedures and to collect samples for comparison drug residue testing. In addition, the Department will review industry records for compliance with drug residue program requirements. The review will seek to determine that the following conditions are met:
(i) Each producer is included in a routine, effective drug residue milk monitoring program utilizing methods evaluated and found acceptable by FDA to test samples for the presence of drug residue.
(ii) The Department receives prompt notification from industry personnel of each occurrence of a sample testing positive for drug residue, and of the identity of each producer identified as a source of milk testing positive for drug residue.
(iii) The Department receives prompt notification from industry personnel of the intended and final disposition of milk testing positive for drug residue, and that disposal of the load is conducted in a manner that removes it from the human or animal food chain, except when acceptably reconditioned under FDA compliance policy guidelines.
(iv) Milk shipment from a producer identified as a source of milk testing positive for drug residue completely and immediately ceases until a milk sample taken from the dairy herd does not test positive for drug residue.
(2) Enforcement.
(i) Any time milk is found to test positive for drug residue, the Department will immediately take action to suspend the producer’s milk shipping privileges to prevent the sale of milk from the producer shipping milk testing positive for drug residue.
(ii) The producer’s milk shipping privileges may be reinstated when a representative sample taken from the producer’s milk, prior to commingling with any other milk, is no longer positive for drug residue.
(iii) The penalty shall be for the value of all milk on the contaminated load plus any costs associated with the disposition of the contaminated load. The Department may accept certification from the violative producer’s milk marketing cooperative or purchaser of milk as satisfying the penalty requirements.
(iv) Whenever a drug residue test is positive, an investigation shall be made to determine the cause. Action shall be taken to prevent future occurrences.
(v) If a producer ships milk testing positive for drug residue three times within a 12-month period, the producer shall follow best management practices that include testing each shipment for drug residues prior to pick-up.
(vi) The actions and procedures of the Department will be in accordance with this chapter and Appendix N of the Grade ‘‘A’’ PMO, regarding drug residue testing and farm surveillance.
Cross References This section cited in 7 Pa. Code § 59a.105 (relating to approved milk graders); and 7 Pa. Code § 59a.114 (relating to inspection and quality testing of milk from producers).
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