Drug Residue Monitoring and Farm Surveillance

Section 785 Section 785.1220  Drug Residue Monitoring and Farm Surveillance This Section describes the Department's Drug Residue Monitoring and Farm Surveillance Program.  It is established to reference safe levels and/or tolerances and to assure milk supplies are in compliance with these safe levels or established tolerances for drug residues in milk. a)         Industry Responsibilities 1)         Monitoring and Surveillance A)        Industry shall screen all bulk milk pick-up tankers for beta lactam drug residues.  Additionally, other drug residues shall be screened for by employing a random sampling program on bulk milk pick-up tankers.  The random bulk milk pick-up tanker sampling program shall represent and include, during any six months, at least four samples collected in at least four separate months.  Samples shall be analyzed as specified by the Department. B)        Bulk milk pick-up tanker testing shall be completed prior to processing the milk.  Bulk milk pick-up tanker samples found to have a violative drug residue shall be retained as determined necessary by the Department.  Industry shall also record all sample results and retain those records for a period of six months. 2)         Reporting and Farm Traceback A)        When a bulk milk pick-up tanker is found to have a violative drug residue, the Department shall be immediately notified of the results and the ultimate disposition of the raw milk. B)        The individual sample collected from each producer's milk that was in the bulk milk pick-up tanker that was found to have a violative drug residue shall be immediately tested to determine which producer or producers have created or contributed to the drug residue. C)        Further pickups of the violative individual producer or producers shall be immediately discontinued until such time that subsequent tests no longer indicate violative drug residues and enforcement requirements of subsection (b)(2) of this Section have been met. b)         Department Responsibilities 1)         Monitoring and Surveillance A)        The Department shall monitor industry surveillance activities by making unannounced on-site inspections to collect samples from bulk milk pick-up tankers and to review industry records of the random sampling program. B)        The Department shall also perform routine sampling and testing for drug residues determined to be necessary. 2)         Enforcement A)        If testing reveals violative drug residues, the milk shall be disposed of in a manner that removes it from the human or animal food chain except where reconditioned under Department approval. B)        When the individual testing as required in subsection (a)(2)(B) of this Section is complete and the tests indicate any drug residue at or above the tolerance and/or safe levels, the producer's permit will be summarily suspended.  Another sample will be taken from milk produced after corrections have been made to determine whether this adulteration is continual.   For the third occurrence of a drug residue in any 12 month period, the Department shall initiate administrative procedures pursuant to revocation of the producer's permit. C)        If the resample shows no violative drug residue, the permit will then be conditionally reinstated until such time as the producer and a licensed veterinarian have completed a quality assurance program, but in no case for longer than 30 days. D)        When the field representative has transmitted to the Department a copy of the quality assurance program completion certificate signed by the producer and a licensed veterinarian, the producer's manufactured raw milk permit shall be fully reinstated. 3)         The following describes the penalty procedures for the Department's drug residue control program for manufactured raw milk. A)        These procedures shall be followed when individual sample testing for drug residues has been completed, test results indicate a violative drug residue, and the producer's or producers' manufactured raw milk permit is summarily suspended in accordance with subsection (b)(2)(B) of this Section.  The producer or producers shall submit to the Department an equivalent penalty to the 96 hour period following the violative shipment for the second and third occurrences in any 12 month period.   The equivalent penalty for the second and third occurrences shall be $4.00 per hundred weight of the milk produced during 96 hours following the violative shipment.  The penalty shall be paid to the Department by the first buyer of the milk, by the last day of the month immediately following the violation.  Following the third occurrence of drug residue violation in any 12 month period, the Department shall initiate administrative procedures, pursuant to Section 785.1200, to permanently revoke the producer's permit. B)        The producer's manufactured raw milk permit will be conditionally reinstated for up to 30 days when a subsequent sample of the producer's milk does not contain a violative drug residue.  The producer and a licensed veterinarian must complete a quality assurance (QA) program within the 30 day conditional reinstatement of the manufactured raw milk permit. C)        When the field representative has transmitted to the Department a copy of the quality assurance program completion certificate signed by the producer and a licensed veterinarian, the producer's manufactured raw milk permit shall be fully reinstated. 4)         All monies collected through the drug residue control program shall be deposited in the Food and Drug Safety Fund and will be dedicated to drug residue prevention efforts, producer education and providing information for the prevention of drug residue. c)         Established Tolerances and/or Safe Levels of Drug Residues 1)         Tolerances for drug residues that may result in milk are set forth in 21 CFR 556 (1999). 2)         "Safe levels" are used by the Department for prosecutorial discretion. They do not legalize residues found in milk that are below the safe level. Safe levels as established by the Federal Food and Drug Administration will be transmitted by the Department via Technical Releases.