345 IAC 8-4-1 Drug residues

Sec. 1. (a) Milk shall be screened for the presence of drug residues as follows: (1) Any milk plant that accepts raw milk shall test each bulk milk pickup tanker for beta lactam drug residues. Each bulk milk pickup tanker shall be sampled after the last producer has been picked up and before any additional commingling of milk using a representative sample from the truck. Samples shall be tested as follows: (A) Using a test that has been approved by the United States Food and Drug Administration for screening milk for drug residues. (B) In a laboratory that is certified by the state veterinarian by an analyst that is certified by the state veterinarian. When a drug residue test is positive, confirmatory testing and testing to determine the farm of origin shall be conducted in accordance with Appendix N of the Grade A Pasteurized Milk Ordinance. (2) The state veterinarian may implement a testing program to test milk from bulk milk pickup tankers for other drug residues. (3) The state veterinarian may implement a testing program to test milk from any source for drug residues. The testing programs may include samples from farm bulk tanks, milk plants, or finished products as part of a monthly quality program or other surveillance program. Samples that test positive for drug residues are subject to the provisions of this section. (4) Milk plants shall keep records of all drug residue tests that are conducted on bulk milk pickup tankers and farm bulk milk tanks and must include the information indicated in Appendix N of the PMO incorporated by reference in 345 IAC 8-3-1. The records shall be kept for not less than two (2) years. (b) All tests completed under this section must meet the following requirements: (1) The test must be a test approved by the United States Food and Drug Administration for screening milk samples for drug residues. (2) The test must be conducted as follows: (A) By an analyst approved by the state veterinarian under the standards in Appendix N of the PMO incorporated by reference in 345 IAC 8-3-1. (B) In a laboratory approved by the state veterinarian under the standards in Appendix N of the PMO incorporated by reference in 345 IAC 8-3-1. (3) A test that is being run to confirm a positive drug residue test result must be the same test that was used to obtain the initial positive drug residue result. A person may use a different confirmatory test, however, if the state veterinarian approves the use of that confirmatory test. The state veterinarian may approve the use of a confirmatory test that is different from a prior test after: (A) evaluating the circumstances surrounding the request; and (B) determining that the use of the proposed confirmatory test is consistent with the purposes of this section. (c) Milk tests positive for drug residues if a test meeting the requirements in subsection (b) indicates the presence of drug residues in the milk at any level. (d) Whenever milk tests positive for drug residues and is confirmed, the following apply: (1) The milk that tests positive for drug residues is adulterated under IC 15-17-2-2 and must be disposed of in a manner that: (A) removes it from the human and animal food chain; or (B) acceptably reconditions the milk under United States Health and Human Services–Food and Drug Administration compliance policy guidelines. (2) The state veterinarian shall determine the origin of the contaminated milk. Milk from the farm of origin creates an imminent hazard to the public health. The state veterinarian shall: (A) suspend the Grade A farm permit or manufacturing grade farm permit; or (B) take other equally effective measures to prevent the sale of milk containing drug residues. (3) When a drug test shows the producer's milk is negative for drug residues, the state veterinarian may: (A) reinstate the farm permit; or (B) take other action to allow the sale of milk for human food. (e) All positive drug residue test results must be called into the office of the state veterinarian immediately, and a written report of the test results must be faxed or delivered to the office of the state veterinarian within twenty-four (24) hours of the test. The producer whose milk tested positive must be notified of the positive drug residue test immediately. The company that conducted the test is responsible for the reporting requirements in this subsection. (f) A producer whose milk tests positive for drug residues shall pay a fine and participate in drug residue education activities as follows: (1) The following is imposed on a producer for the first positive test for drug residues within a twelve (12) month period: (A) The positive producer must pay a fine to the board equal to the result of the following equation: (DP) (2 days) ($3) - (PR) However, if the result is less than five dollars ($5), then the fine is five dollars ($5). (B) The positive producer must, in conjunction with his or her veterinarian and an official of the board: (i) complete an approved protocol to prevent future drug residue violations; and (ii) provide proof of completion to the board, office of the state veterinarian within thirty (30) days of the drug residue violation. Failure to complete the protocol and submit proof of completion within thirty (30) days will result in action to suspend the producer's permit. (2) The following is imposed for a second positive test for drug residues within a twelve (12) month period: (A) The fine set forth in subdivision (1) is imposed. (B) The positive producer must, in conjunction with his or her veterinarian and an official of the board: (i) complete an approved protocol to prevent future drug residue violations; and (ii) provide proof of completion to the board, office of the state veterinarian within thirty (30) days of the drug residue violation. Failure to complete the protocol and provide proof of completion will result in action to suspend the producer's permit. (C) The producer must attend a meeting called by the state veterinarian to discuss the violations and demonstrate that appropriate practices have been implemented to mitigate the risk of further residue violations. (3) The third or subsequent positive test result for drug residues within a twelve (12) month period shall result in the following: (A) The board shall initiate action under IC 15-18 to suspend or revoke a producer's Grade A permit if the producer has a permit. (B) The fine set forth in subdivision (1) is imposed. (C) If a producer requests reinstatement of the producer's permit, the producer must submit to the state veterinarian a set of written procedures that he or she will follow to prevent future drug residue violations. The procedures must be specific, practical, and reasonably likely to lessen the possibility of a drug residue violation when followed by the producer. (g) The following definitions apply throughout this section: (1) "DP" or "daily production" means the amount of milk, measured by hundredweight, produced by the positive producer in one (1) day, measured on the day in which the drug residue violation occurred. (2) "PR" or "producer reimbursement" means an amount assessed against the positive producer to reimburse others for milk contaminated by the positive producer's contaminated milk, not including the value of the positive producer's contaminated milk for which he or she was not paid. (3) "Revocation period" means the period after a Grade A producer's permit is revoked under this rule that he or she may not apply for a Grade A permit. (h) The following shall apply to penalties imposed by this section: (1) In cases where the positive producer holds a Grade A permit from the board, the provisions in this section shall operate in place of and as an equivalent to the penalties in Appendix N of the Pasteurized Milk Ordinance. (2) All monetary penalties must be: (A) paid by the producer; and (B) received by the office of the state veterinarian within sixty (60) days of notice of the drug residue violation. (3) The state veterinarian may, by special permit, allow a producer that objects to the imposition of a fine to dump two (2) days of milk production on a first offense and four (4) days of milk production on the second or third offense instead of paying a monetary fine where payment of a fine would impose undue hardship on a producer. The state veterinarian may: (A) set the conditions under which the milk is to be dumped; and (B) require documentation from the producer showing the circumstances under which the milk was dumped. (4) Proof that a producer reimbursement was in fact assessed must be submitted to the office of the state veterinarian within sixty (60) days of notice of the drug residue violation along with any monetary penalty due. (5) No penalty may exceed one thousand dollars ($1,000) for a first offense or two thousand dollars ($2,000) for a subsequent offense. Civil penalties collected under this section must be deposited in the dairy drug residue abatement fund established under IC 15-18-1-31. (i) The state veterinarian may suspend the permit of a producer that does not comply with the requirements of this rule within the designated time periods allowed under this rule until such time as the violation is remedied. (j) The following are examples that illustrate the calculation of the fine imposed by this rule: (1) A fine is calculated as follows for a first or subsequent offense: (A) Total positive truck load CWT: 500 (B) Positive producer's CWT on positive tanker (two (2) days' production): 100 (C) Producer's daily production CWT: 50 (D) Co-op requires producer to pay for other producers' milk that is contaminated at fifteen dollars ($15) per CWT. Penalty = (DP) (2 days) ($3) - (PR). = [50 (2) ($3)] - [(500 - 100) ($15)]. = [$300 fine] -[$6,000 reimbursement paid to other producers]. Because the reimbursement to other producers exceeded the fine, no money is payable to the state as long as proof of the reimbursement assessment is provided to the board. (2) A fine is calculated as follows for a first or subsequent offense: (A) Total positive truck load CWT: 500 (B) Positive producer's CWT on positive tanker (two (2) days' production): 400 (C) Producer's daily production CWT: 200 (D) Co-op requires producer to pay for other producers' milk that is contaminated at fifteen dollars ($15) per CWT. Penalty = (DP) (2 days) ($3) - (PR). = [200 (2) ($3)] - [(500 - 400) ($15)]. = [$1,200 fine] - [$1,500 reimbursement paid to other producers]. Because the reimbursement to other producers exceeded the fine, no money is payable to the state as long as proof of the reimbursement assessment is provided to the board. (3) A fine is calculated as follows for a first or subsequent offense: (A) Positive bulk tank on monthly quality check or otherwise. (B) Producer's daily production (CWT): 50 Penalty = (DP) (2 days) ($3) - (PR). = [50 (2) ($3)] - 0. Because there was no reimbursement to other producers, all of the three hundred dollar ($300) fine is payable to the state.