Section 001-329-XIII - EXAMINATION OF MILK AND MILK PRODUCTSA. SAMPLE COLLECTION1. It shall be the responsibility of the milk hauler to collect a representative sample of milk from each farm bulk tank, silo, or from a properly installed and operated in-line sampler or aseptic sampler that is approved for use by the Department and FDA to collect samples, prior to transferring or as transferring milk utilizing an aseptic sampler from a farm bulk tank, silo, truck or other container. All samples must be collected and delivered to a milk plant, receiving station, transfer station or other location approved by the Department.2. It shall be the responsibility of the industry plant sampler to collect a representative sample of milk from each milk tank truck or from a properly installed and operated aseptic sampler, which is approved for use by the Department and FDA to collect representative samples, prior to transferring milk from a milk tank truck. Industry plant samplers collect official samples for regulatory purposes at a milk plant, receiving station or transfer station.3. During any consecutive six (6) months, at least four (4) samples of raw milk for pasteurization, ultra-pasteurization, or aseptic processing and packaging must be collected, in at least four (4) separate months, except when three (3) months show a month containing two (2) sampling dates separated by at least twenty (20) days. These samples must be obtained under the direction of the Department or must be taken from each producer under the direction of the Department and delivered in accordance with this Section.4. During any consecutive six (6) months, at least four (4) samples of raw milk for pasteurization, ultra-pasteurization or aseptic processing and packaging must be collected in at least four (4) separate months, except when three (3) months show a month containing two (2) sampling dates separated by at least twenty (20) days. These samples must be obtained by the Department, from each milk plant after receipt of the milk by the plant and prior to pasteurization, ultra-pasteurization or aseptic processing and packaging.5. During any consecutive six (6) months, at least four (4) samples of heat-treated milk products, from plants offering such products for sale, must be collected in at least four (4) separate months, except when three (3) months show a month containing two sampling dates separated by at least 20 days and delivered to the Department in accordance with this section.6. During any consecutive six (6) months, at least four (4) samples of pasteurized milk, ultra-pasteurized milk, flavored milk, flavored reduced fat or low-fat milk, flavored nonfat (skim) milk, each fat level of reduced fat or low-fat milk and each milk product defined in this Rule, must be obtained by the Department in at least four (4) separate months, except when three (3) months show a month containing two (2) sampling dates separated by at least twenty (20) days from every milk plant. All required sampling and testing of pasteurized and ultra-pasteurized milk and milk products to be done only when there are test methods available that are validated by FDA and accepted by the NCIMS. Products with no validated and accepted methods are not required to be tested. Aseptically processed and packaged milk and milk products shall be exempt from the sampling and testing requirements of this item. Samples must include a representative sample of every specific type of milk and milk product offered for sale.7. During any consecutive six (6) months, at least four (4) samples of each variety, flavor or type of "not pasteurized" milk and milk products must be collected in at least four (4) separate months, except when three (3) months show a month containing two (2) sampling dates separated by at least twenty (20) days, from every milk distributor, by the department.8. During any consecutive six (6) months at least four (4) sample sets of single service containers from each manufacturing line, must be collected by the Department in at least four (4) separate months, except when three (3) months show a month containing two (2) sampling dates separated by at least twenty (20) days from every manufacturer. A sample set is at least four (4) containers.9. Once every twelve (12) months at least four (4) samples of multi-use containers, must be collected by the Department from each milk distributor.10. Samples of milk and milk products must be taken while the milk and milk products are in the possession of the producer, milk plant or distributor at any time prior to delivery to the store or consumer. All retail samples shall be collected from the labeled containers in which they are sold. Samples of milk and milk products from dairy retail stores, food service establishments, grocery stores and other places where milk and milk products are sold may be examined periodically as determined by the Department and the results of such examination shall be used to determine compliance with Sections II and VIII. Managers of such establishments must furnish the Department, upon request, with the names of all distributors from whom milk or milk products are obtained.11. Milk and milk products not produced continuously throughout the year are exempt from being sampled four (4) times in any six (6) consecutive months. Frozen dairy desserts and eggnog must be sampled one (1) time, each month during the production season.12. Water samples, from the water supply for the milk house and milking operations, must be taken at least once every three (3) years or more frequently at the Department's discretion. The Department may also, at its discretion, inspect the water supply system including any disinfection components as applicable. Water supplies with buried well casing seals, must be sampled at intervals no greater than six (6) months apart. Water samples, from the water supply for milk plant purposes, must be collected every six (6) months for IMS plants and every twelve (12) months for all other plants. Recirculating water must be sampled every six (6) months for all dairy plants. Dairy farms and dairy plants that use municipal water supplies shall be exempt from these water testing requirements. (a) Failure of an official water sample will result in a letter being sent to the farm, plant, dairy or any other milking operation requiring a clean water supply giving notice of the failure. Water will be resampled at a future date to be determined by the Department;(b) After a second sample failure a warning letter or notice of intended enforcement will be sent to the farm, plant, dairy or any other milking operation requiring a clean water supply giving notice that a third sample will be taken. (c) If the third sample fails the permit or license to operate will be suspended, until such time as a clean (satisfactory) water sample is obtained, but not more than a period of 30-days pending an administrative hearing to indefinitely suspend the permit or license.13. Failure to provide the required samples of milk or milk products as specified in this section may result in enforcement action up to and including suspension of permit or license.B. METHODOLOGY FOR EXAMINATION OF SAMPLES Samples from sources participating in FDA's voluntary IMS program must be examined and tested as prescribed by the PMO using test methodology validated and accepted by FDA.
1. Required bacterial counts, somatic cell counts and cooling temperature checks must be performed on raw milk from the farm bulk tank. In addition, drug tests of each producer's milk must be conducted at least four (4) times during any consecutive six (6) months.2. Required bacterial counts, somatic cell counts and cooling temperature checks must be performed on raw milk for pasteurization, ultra-pasteurization or aseptic processing and packaging.3. Required bacterial counts, coliform determinations, drug tests, somatic cell counts and cooling temperature checks must be performed on heat treated milk and milk products.4. Required bacterial counts, drug tests, coliform determinations, and cooling temperature checks must be performed on not pasteurized milk and milk products.5. Required bacterial counts must be performed on single service and multi-use containers.6. When multiple samples of the same milk or milk products, except for aseptically processed milk and milk products, are collected from the same producer or processor from multiple tanks or silos on the same day, the laboratory results are averaged arithmetically by the Department and recorded as the official results for that day. This is applicable for bacterial (standard plate count and coliform), somatic cell count and temperature determinations only.C. VIOLATIONS 1. Whenever two (2) of the last four (4) bacterial counts, somatic cell counts, coliform determinations, or cooling temperatures, taken on separate days, exceed the standard for the milk and/or milk products as defined in this Rule or the PMO, the Department shall send a written notice to the person concerned. This notice shall be in effect so long as two (2) of the last four (4) consecutive samples exceed the standard. An additional sample must be taken within twenty-one (21) days of the sending of such notice, but not before the lapse of three (3) days. Immediate administrative suspension of the permit, and/or court action, shall be instituted whenever the standard is violated by three (3) of the last five (5) bacterial counts, somatic cell counts, coliform determinations or cooling temperatures.2. When a milk plant's product is in violation of the standard for three (3) of the last five (5) tests, the plant's senior management will be notified (by telephone and certified letter) to suspend distribution of product. The Department will also be notified (by telephone and/or other methods of communication) and they will conduct a plant inspection as soon as possible. This inspection must note the probable cause of the violation(s) and any corrective action(s) necessary. After inspection, the plant will be allowed to resume distribution of product. Product will be sampled on an accelerated schedule (not more than two (2) samples per week for three (3) weeks). Once the plant has been inspected and allowed to resume distribution, previous test history will not be used to calculate two (2) out of four (4) or three (3) out of five (5) violations. Calculation will be based on test results from the accelerated sampling schedule.3. When a producer's bulk tank milk is in violation of standard for three (3) of the last five (5) samples, the permit must be suspended by the department and the following steps shall be taken: (a) For violation of bacterial standard, the Department must conduct a farm inspection. This inspection must note the probable cause of the violation(s) and any corrective action(s) necessary. A permit must be issued upon inspection. (b) For violation of somatic cell standard, permit will be issued when an official bulk tank sample is tested within the standard established by this Rule at an official laboratory. For bacterial or somatic cell violations, the producer's bulk tank milk will be sampled on an accelerated schedule (not more than two (2) samples per week for three (3) weeks). Once the accelerated sampling has begun, the previous test history will not be used to calculate two (2) out of four (4) or three (3) out of five (5) violations. Calculations will be based on test results from the accelerated sampling schedule.
4. Whenever a phosphatase test is positive, the cause will be determined. Where the cause is improper pasteurization, it must be corrected and any milk or milk product involved must not be offered for sale.5. Whenever a pesticide residue test is positive, an investigation will be made to determine the cause and the cause must be corrected. An additional sample will be taken and tested for pesticide residues and no milk or milk products will be offered for sale until it is shown by a subsequent sample to be free of pesticide residues or below the actionable levels established for such residues.6. Whenever a drug residue test is confirmed positive, an investigation must be made to determine the cause, and the cause must be corrected in accordance with the provisions of Section XIII. 7. Whenever a container or containers of aseptically processed milk or milk product is found to be unsterile, due to under-processing, the Department will consider this to be an imminent hazard to public health and suspend the permit of the milk plant for the sale of aseptically processed milk and milk products. Aseptically processed milk and milk product must not be sold until it can be shown that the processes, equipment and procedures used are suitable for consistent production of a sterile product. All product from the lot that was found to contain one or more unsterile units must be recalled and disposed of as directed by the Department.8. When single service or multi-use containers exceed the standard in three (3) out of four (4) samples taken at random on a given day, the Department must conduct an inspection to determine the probable cause(s) and note corrective action(s). 9 When a water sample is unable to meet bacteriological standards for three (3) consecutive tests, the Department may require a written corrective action plan specifying steps to be taken providing a continuous source of bacteriologically safe water. This plan may include a continuous disinfection utilizing UV light, or continuous chemical treatment. See Appendix D of the PMO.D. Independent testing of not pasteurized milk products When the official milk laboratory operated by the Department has tested not pasteurized milk products and determined that those milk products do not meet the standards for not pasteurized milk products established by this rule, the person operating the milk plant that processed the milk products may request further testing by an independent FDA certified laboratory. The not pasteurized milk products must not be sold pending the completion of the independent testing. Within three (3) business days of receipt by the Department of a request for independent testing, the Department shall obtain duplicate samples of the not pasteurized milk products from the processor. These samples will be delivered by the Commissioner or his/her agent to the state milk laboratory and shipped by the Department to an independent FDA certified laboratory for testing. The processor is responsible for the cost of shipping and testing performed by the independent FDA certified laboratory. The test results will be sent by the Department to the processor within 24-hours of receiving the results.
The not pasteurized products in dispute may be offered for sale only after testing at the official milk laboratory and the independent official laboratory has been completed and the Department has received results from either laboratory which are within the established standards set forth in this rule. If the results from both the independent official laboratory and the official milk laboratory do not meet the standards for not pasteurized products, the products must not be sold until they meet the established standards.
E. Methods of Analysis1. Samples must be analyzed at an appropriate official or officially designated laboratory. All sampling procedures, including the use of approved in-line samplers and approved aseptic samplers for milk tank trucks or for farm bulk tanks and/or silos, and required laboratory examination must be in substantial compliance with the most current edition of Standard Methods for the Examination of Dairy Products (SMEDP) of the American Public Health Association and the PMO. Such procedures, including the certification of sample collectors, and examinations must be evaluated in accordance with the "Procedures Governing the Cooperative State-Public Health Service/Food and Drug Administration Program on the National Conference on Interstate Milk Shipments." Aseptically processed milk and milk products packaged in hermetically sealed containers must be tested in accordance with the FDA's Bacteriological Analytical Manual. Examination and tests to detect adulterants, including pesticides, must be conducted as the Department requires. When the Commissioner of the FDA determines that a potential problem exists with animal drug residues or other contaminants in the milk supply, samples must be analyzed for the contaminant by a method(s) determined by the FDA to be effective in determining compliance with actionable levels or established tolerances. This testing will continue until such time that the Commissioner of the FDA is reasonably assured that the problem has been corrected. The determination of a problem is to be based upon: 1. Sample survey results;2. USDA tissue residue data from cull and other slaughtered dairy animals;3. Animal drug disappearance and sales data;4. State feedback; and 5. Other relevant information. Assays of milk and milk products as defined in this Rule, including aseptically processed and packaged milk and milk products, to which vitamin(s) A and/or D have been added for fortification purposes, must be made at least annually in a laboratory which has been accredited by the FDA and which is acceptable to the Department, using the test methods acceptable to FDA and other official methodologies which give statistically equivalent results to the FDA methods. Vitamin testing laboratories are accredited if they have one (1) or more certified analysts and meet the quality control requirements of the program established by FDA. Laboratory accreditation and analyst certification parameters are specified in the Evaluation of Milk Laboratories 2019 Revision (EML) manual.
In addition, all facilities fortifying products with vitamin(s) must keep volume control records. These volume control records must cross reference the form and amount of vitamin D, vitamin A and/or vitamin A & D used with the amount of products produced and indicate a percent of expected use, plus or minus.
2. The following referenced methods of analysis are from "Official Methods of Analysis of the Association of Official Analytical Chemists", 16th Ed. (1997), which is incorporated by reference. (a) Milk fat content--As determined by the method, "Roese-Gottlieb Method (Reference Method) (11)--Official Final Action", under the heading "Fat".(b) Milk solids not fat content-Calculated by subtracting the milk fat content from the total solids content as determined by the method, "Method I--Official Final Action", under the heading "Total Solids".(c) Titratable acidity--As determined by the method, "Acidity (2)--Official Final Action", or by an equivalent potentiometric method.(d) Vitamin D content - "Vitamin D - Official Final Action". NOTE: Milk from animals not currently in the Grade "A" PMO may be labeled as Grade
"A" and IMS listed upon FDA's acceptance of validated Grade "A" PMO, Section 6. of this Ordinance and Appendix N. test methods for the animal to be added. (Refer to M-a-98, latest revision, for the specific milk and/or milk products that have FDA validated and NCIMS accepted test methods.)
01-001 C.M.R. ch. 329, § XIII