Section 001-329-XIV - DRUG RESIDUE TESTING AND FARM SURVEILLANCE This Section is established to reference safe levels and/or establish tolerances and to assure that milk supplies are in compliance with these safe levels or established tolerances for drug residues in milk. Additional requirements and guidelines for determining compliance with these requirements may be found in the PMO.
A. INDUSTRY RESPONSIBILITIES 1. monitoring and surveil Lance - Industry must screen all bulk milk pickup tankers, regardless of final use, for beta lactam drug residues. Specific requirements for establishing a drug residue testing program can be found in Appendix N of the PMO. Additionally, other drug residues must be screened for by employing a random sampling program on bulk milk pickup tankers when the Commissioner of the Maine Department of Agriculture, Conservation and Forestry or the Commissioner of the FDA determines that a potential problem exists as cited in Section 6 of the PMO. The random bulk milk pickup tanker sampling program must represent and include, during any consecutive six (6) months, at least four (4) samples collected in at least four (4) separate months, except when three (3) months show a month containing two sampling dates separated by at least twenty (20) days. Samples collected under this random sampling program must be analyzed as specified by FDA. (Refer to section 6 of the PMO) The bulk milk pickup tanker must be sampled after the last producer has been picked up and before any additional commingling. These bulk milk pickup tanker samples may be collected from an approved aseptic sampler. The sample must be representative. Bulk milk pickup tanker testing must be completed prior to processing the milk. Industry samplers must be evaluated according to the requirements specified in Section XIII, THE EXAMINATION OF MILK AND MILK PRODUCTS of this Rule and at the frequency addressed in Section IV, I NSPECTION OF DAIRY FARMS AND MILK PLANTS of this Rule. Bulk milk pickup tanker samples found to be confirmed positive for drug residues must be retained as determined necessary by the Department. All presumptive positive test results for drug residues from analysis done on commingled raw milk tanks, bulk milk pickup tankers, farm raw milk tanks (only milk offered for sale) or finished milk or milk product samples must be reported to the Department.
2. REPORTING AND FARM TRACEBACK - When a bulk milk pickup tanker is found to be positive for drug residues, the Department must be immediately notified of the results and the ultimate disposition of the raw milk. The producer samples from the bulk milk pickup tanker, found to be positive for drug residues, must be individually tested to determine the farm of origin. The samples must be tested as directed by the Department.
The producer must be notified by telephone and in writing by the milk plant.
Further pickups of the violative individual producer must be immediately discontinued, until such time, that subsequent tests are no longer positive for drug residues.
3. RECORD REQUIREMENTS Records of all sample results must be maintained for a minimum of six (6) months by the milk plant at the location where the tests were run, and/or another location as directed by the Department. Such records shall be made available to the Department for inspection and copying, upon request and at all reasonable times.
Results of all testing may be recorded in any format acceptable to the Department and must include at least the following information:
1. Identity of the person doing the test;2. Identity of the bulk milk pickup tanker being tested*;3. Date/time the test was performed (Time, Day, Month and Year);4. Identity of the test performed/lot #/any and all controls (+/-);6. Follow-up testing if initial test was positive/any and all controls (+/-);7. Site where test was performed and8. Prior test documentation must be provided for a presumptive positive load. *Include the BTU number(s) of the farms present on the bulk milk pickup tanker with the above information.
B. DEPARTMENT RESPONSIBILITIES 1. Upon receipt of notification from industry of a bulk milk pickup tanker, which contains milk from another State(s), that is found to be presumptive positive for drug residues, it is the responsibility of the Department to notify the Regulatory Agency(ies) of all States of origin. 2. MONITORING AND SURVEILLANCE - The Department will monitor industry surveillance activities during either routine or unannounced, on-site quarterly inspections to collect samples from bulk milk pickup tankers and to review industry records of the random sampling program. Samples should be collected and analyzed from at least ten percent (10%) of the bulk milk pickup tankers scheduled to arrive on the day of the inspection. The method used must be appropriate for the drug being analyzed and must be capable of detecting the same drugs at the same concentrations as the method being used by industry.3. The Department or Laboratory Evaluation Officer (LEO) may take known samples with him/her on the audit visit and observe the industry analyst test the samples. Receiving locations that choose to certify all receiving analysts, certified under the provisions of the NCIMS Laboratory Certification Program, are exempt from the sample collection requirements of this Section. Receiving locations where all approved receiving Industry Analysts and Industry Supervisors successfully participate in a biennial on-site evaluation and annual split sample comparisons by LEOs are also exempt from the sample collection requirements of this Section. A review must include, but not be limited to, the following:
(a) Is the program an appropriate routine monitoring program, utilizing appropriate test methods for the detection of drug residues?(b) Is each producer's milk represented in a testing program for drug residues and tested at the frequency prescribed in A.1. above for drug residues?(c) Is the program assuring timely notification to the Department of positive results, the ultimate disposition of the bulk milk pickup tanker milk and of the trace back to the farm of origin? (d) Is farm pickup suspended until subsequent testing establishes the milk is no longer positive for drug residues? To satisfy these requirements:
1. There should be an agreement between the Department and industry that would specify how this notification is to take place. This notification must be "timely" for example by telephone or electronic device, and supported in writing.2. The ultimate disposition should either be prearranged in an agreement between the Department and the industry, or physically supervised by the Department. If testing reveals milk positive for drug residues, the milk shall be disposed of in a manner that removes it from the human or animal food chain, except where acceptably reconditioned under FDA Compliance Policy Guide (CPG 675.200 "Division of Adulterated Food to Acceptable Animal Feed Use" current revision).3. All screening test positive (confirmed) loads must be broken down (producer traceback) using the same or an equivalent test method (FDA, NCIMS Milk Safety Program, M-I-96-10, Drug Residue Test Methods for Confirmation, latest version). Confirmation tests (load and producer trace back/permit action) must be performed by an Official or Officially Designated Laboratory or Certified Industry Supervisor. Positive producers must be handled in accordance with Section XIII of this rule.4. The suspension and discontinuance of farm bulk milk tank pick up is the responsibility of the industry, under the direction and supervision of the Department. At the discretion of the Department, records must be maintained by industry and/or the Department that: a. Establish the identity of the producer and the identity of the load that tested positive; and b. Establish that no milk is picked up from the positive testing producer until the Department has fulfilled their obligations under Section XIII. B.2. of this Rule and cleared the milk.4. Sufficient records shall be reviewed to assure that all farm bulk milk pickup tankers are sampled before commingling and the results were made available to the appropriate BTU(s).5. The Department shall also perform routine sampling and testing for drug residues determined to be necessary as outlined in the PMO6. DRUG RESIDUE ENFORCEMENT - If testing reveals milk positive for drug residues, the milk must be disposed of in a manner that removes it from the human or animal food chain, except where acceptably reconditioned under FDA Compliance Policy Guide. The Department shall determine the producer(s) responsible for the violation. a.Suspension: Any time milk is found to test positive for a drug residue, the Department will immediately suspend the producer's Grade "A" permit or equally effective measures will be taken to prevent the sale of milk containing drug residues.b.Penalties: Future pick-ups are prohibited until subsequent testing reveals the milk is free of drug residue. The penalty will 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. c.Reinstatement: The Grade "A" producer permit may be reinstated, or other action taken, to allow sale of milk for human food, when a representative sample taken from the producer's milk, prior to commingling with any other milk, is no longer positive for drug residue.d.Follow Up: Whenever a drug residue test is positive an investigation must be made to determine the cause. The investigation will include a farm inspection completed by the Department to determine the cause of the residue and actions taken to prevent future violations including:
(a) On farm changes in procedures necessary to prevent future occurrences as recommended by the Department.(b) Discussion and education on the Drug Residue Avoidance Control measures outlined in the PMO and Milk and Dairy Beef Residue Prevention Protocol. Permit Revocation: After a third violation in a twelve (12) month period, the Department may initiate proceedings to revoke the producer's Grade A permit.
7. DEPARTMENT RECORDS - In the event a processor reports a positive tanker result, the Department's records should indicate the following:a. What were the Department's directions?b. When was the Department notified? By whom?c. What was the identity of the load?d. What screening and/or confirmatory test(s) were used and who were the analyst(s)?e. What was the disposition of the adulterated milk?f. Which producer(s) was responsible?g. Record of negative test results prior to subsequent milk pickup from the violative producers(s).C. APPEALS PROCESS If a producer wishes to dispute producer traceback test results, milk from the original sample will be sent by the milk plant to the DQCI laboratory in Minnesota for high pressure liquid chromatograph (HPLC) analysis. Costs of testing will be paid by the producer if the sample is determined to be positive or false violative. Testing costs plus costs of the discarded milk will be paid by the processor if the HPLC results indicate a false positive on original screening test.
01-001 C.M.R. ch. 329, § XIV