1. (1) It shall be the responsibility of the bulk milk hauler or sampler to collect a representative sample of milk from each farm bulk milk tank and/or silo or from a properly installed and operated in-line-sampler or aseptic sampler, that is approved for use by the Health Officer and FDA to collect representative samples, prior to transferring or as transferring milk utilizing an aseptic sampler from a farm bulk milk tank and/or silo, truck, or other container. All samples shall be collected and delivered to a milk plant, frozen dessert plant, receiving station, transfer station, or other location and approved by the Health Officer.

2. (2) It shall be the responsibility of the industry plant sampler to collect a representative sample of milk for Appendix N testing from the following:

   1. (a) Each milk tank truck or from a properly installed and operated aseptic sampler, which is approved for use by the Health Officer and FDA to collect representative samples, prior to transferring milk from a milk tank truck; and/or
   2. (b) Each raw milk supply that has not been transported in bulk milk pickup tankers or from a properly installed and operated in-line sampler or aseptic sampler, which is approved for use by the Health Officer and FDA to collect representative samples, prior to transferring the milk from a farm bulk milk tank(s)/silo(s), milk plant raw milk tank(s) and/or silo(s), other raw milk storage container(s), etc. for processing at that location.

3. (3) During any consecutive six (6) months, at least four (4) samples of raw milk for pasteurization, ultra pasteurization, aseptic processing and packaging, or retort processed after packaging shall be collected from each producer 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 shall be obtained under the direction of the Health Officer or shall be taken from each producer under the direction of the Health Officer and delivered in accordance with this section. During any consecutive six (6) months, at least four (4) samples of raw milk for pasteurization, ultra pasteurization, or aseptic processing and packaging, or retort processed after packaging shall 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 shall be taken by the Health Officer from each milk plant after receipt of the milk by the plant and prior to pasteurization, ultra pasteurization, aseptic processing and packaging, or retort processed after packaging. During any consecutive six (6) months, at least four (4) samples of pasteurized milk, ultra pasteurized milk, flavored milk, flavored reduced fat or lowfat milk, flavored non-fat (skim) milk, each fat level of reduced fat or lowfat milk, and each milk product defined in these rules, shall be collected by the Health Officer in at least four (4) separate months, except when three (3) months show a month obtaining two (2) sample dates separated by at least twenty (20) days from every milk and frozen dessert plant. All pasteurized and ultra-pasteurized milk and/or milk products required sampling and testing is to be conducted only when there are test methods available that are validated by FDA and accepted by the NCIMS. Milk and/or milk products that do not have validated and accepted methods are not required to be tested (refer to M-a-98, latest revision), for the specific milk and/or milk products that have FDA validated and NCIMS accepted test methods. Aseptically processed and packaged low-acid milk and/or milk products and retort processed after packaged low-acid milk and/or milk products shall be exempt from the sampling and testing requirements of this Item. During any consecutive six (6) months, at least four (4) samples of each frozen dessert product and frozen dessert mix for resale defined in these rules shall be taken from every frozen dessert plant except when three (3) months show a month obtaining two (2) sample dates separated by at least twenty (20) days from every milk and frozen dessert plant. In addition, the Health Officer shall collect and examine monthly at least one (1) sample of each frozen dessert mix being manufactured for resale. Sample of milk, milk products, and frozen desserts shall be taken while in possession of the producer or distributor at any time. Samples of milk, milk products, and frozen desserts from dairy retail stores, food service establishments, grocery stores, and other places where milk, milk products, and frozen desserts are sold shall be examined periodically as determined by the Health Officer. Proprietors of such establishments shall furnish the Health Officer, upon request, with the name of all distributors from whom milk, milk products, or frozen desserts are obtained.

   Note: The sampling of milk and/or milk products from locations where milk and/or milk products are sold as cited above, shall not be applicable to a TPC authorized under the ICP.

4. (4) Required bacterial counts, somatic cell counts, and cooling temperature checks shall be performed on raw milk for pasteurization, ultra-pasteurization, aseptic processing and
   Chapter 420-3-16 Health
   Supp. 12/31/18 3-16-40
   packaging, or retort processed after packaging. In addition, drug tests for Beta Lactams on each producer’s milk shall be conducted at least four (4) times during any consecutive six (6) months.

5. (5) All pasteurized and ultra-pasteurized milk and/or milk products required sampling and testing to be done only when there are test methods available that are validated by FDA and accepted by the NCIMS, otherwise there would not be a requirement for sampling. Required bacterial counts, coliform counts, drug tests for Beta Lactams, phosphatase, and cooling temperature determinations shall be performed on Grade “A” pasteurized and ultra-pasteurized milk and/or milk products defined in this rule only when there are validated and accepted test methodology (refer to M-a-98, latest revision), for the specific milk and/or milk products that have FDA validated and NCIMS accepted test methods.

   Note: When multiple samples of the same milk and/or milk products, except for aseptically processed and packaged low-acid milk and retort processed after packaged low-acid milk and/or 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 Health Officer or by personnel approved by the Milk Laboratory Control Agency at an official or officially designated laboratory, with industry consent where applicable, 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.

6. (6) Whenever two (2) of the last four (4) consecutive bacterial counts (except those for aseptically processed milk and milk products), somatic cell count, coliform determinations, or cooling temperatures, taken on separate days, exceed the limit of the standard for the milk, milk products, and/or frozen desserts, the Health Officer shall send a written notice thereof to the person concerned. This notice shall be in effect, so long as two (2) of the last four (4) consecutive samples exceed the limit of the standard. An additional sample shall be taken within twenty-one (21) days of the sending of such notice, but not before the lapse of three (3) days. Immediate suspension of permit in accordance with Rule 420-3-16-.04 and/or court action shall be instituted whenever the standard is violated by three (3) of the last five (5) bacterial counts (except those for aseptically processed milk and milk products), coliform determinations, cooling temperatures, or somatic cell counts.
7. (7) Laboratory facilities shall be provided at every plant to determine the presence of antibiotics in milk and/or frozen desserts. Every tank truck of raw milk shall be examined for the presence of antibiotics upon arrival at the plant. Such examinations shall be made before the milk is processed and milk containing antibiotics shall not be processed. The Health Officer shall be notified immediately of all positive antibiotic tests. Appropriate records shall be maintained at the plant showing the results of all examinations.
8. (8) Whenever a phosphatase test is positive, the cause shall be determined. Where the cause is improper pasteurization, it shall be corrected and any milk, milk product, or frozen dessert involved shall not be offered for sale. Whenever a product does not meet the butterfat standards as prescribed in these rules, the product shall not be offered for sale.
9. (9) Whenever a pesticide residue test is positive, an investigation shall be made to determine the cause, and the cause shall be corrected. An additional sample shall be taken and tested for pesticide residues and no milk, milk product, or frozen dessert as defined in this rule shall 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.
10. (10) Whenever a drug residue test is confirmed positive, an investigation shall be made to determine the cause, and the cause shall be corrected in accordance with the provisions of Appendix N.
11. (11) Samples shall 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 milk tanks and/or silos, and required laboratory examinations shall be in substantial compliance with the most current editions of Standard Methods for the Examination of Dairy Products (SMEDP) of the American Public Health Association, Official Methods of Analysis (OMA) and the Association of Official Analytical Chemists (AOAC), and International Official Methods of Analysis (IOMA). Such procedures, including the certification of sample collectors and examinations shall be evaluated in accordance with the procedures.
12. (12) Assays of milk and/or milk products as defined in this rule, including aseptically processed and packaged low-acid milk and/or milk products and retort processed after packaged low-acid milk and/or milk products, to which vitamin(s) A and/or D have been added for fortification purposes, shall be conducted at least annually in a laboratory, which has been accredited by FDA and which is acceptable to the Health Officer, using test methods acceptable to FDA or other official methodologies, which gives statistically equivalent results to the FDA methods (refer to M-a-98, latest revision), for the specific milk and/or milk products that have FDA validated and NCIMS accepted test methods for vitamins). 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 (EML) manual. In addition, all milk plants fortifying milk and/or milk products with vitamins shall keep volume control records. These volume control records shall cross reference the form and amount of vitamin D, vitamin A and/or vitamins A and D used with the amount of milk and/or milk products produced and indicate a percent of expected use, plus or minus.

13. (13) Administrative Procedures

    1. (a) All violations of bacteria, coliform, confirmed somatic cell counts, and cooling temperature standards should be followed promptly by inspection to determine and correct the cause (refer to Appendix E). Aseptically processed milk and milk products packaged in hermetically sealed containers are exempt from the refrigerated storage requirements of this rule.
    2. (b) Therefore, whenever a breakdown in the processing or packaging of these products occurs, an imminent hazard to public health exists. Prompt action is needed by the Health Officer.

    3. (c) Laboratory Techniques - Procedures for the collection, including the use of approved in-line samplers and approved aseptic samplers for milk tank trucks or for farm bulk milk tanks and/or silos, and the holding of samples; the selection and preparation of apparatus, media, and reagents; and the analytical procedures, incubation, reading, and reporting of results, shall be in substantial compliance with the FDA/NCIMS 2400 Forms, SMEDP and OMA. The procedures shall be those specified therein for:

       1. 1. Bacterial count at 32°C Standard Plate Count (SPC) or Petrifilm Aerobic Count (PAC) methods (refer to M-a-98, latest revision, for the specific milk and/or milk products for which these tests are approved).
       2. 2. Alternate methods, for bacterial counts at 32°C Plate Loop Count (PLC), Spiral Plate Count (SPLC), BactoScan FC (BSC), TEMPO AC-Aerobic Count (TAC), and Peel Plate AC- Aerobic Count (PPAC) methods (refer to M-a-98, latest revision, for the specific milk and/or milk products for which these tests are approved).
       3. 3. Coliform count at 32°C Coliform Plate Count (CPC), Petrifilm Coliform Count (PCC) and/or High Sensitivity Coliform Count (HSCC), TEMPO CC-Coliform Count (TCC) and Peel Plate E. Coli and Coliform (PPEC) and/or Peel Plate E. Coli and Coliform High Volume Sensitivity (PPECHVS) methods (refer to M-a-98, latest revision, for the specific milk and/or milk products for which these tests are approved).
       4. 4. A viable bacterial count of nonfat dry milk shall be made in accordance with the procedures in SMEDP for the SPC or PAC of Dry Milk, except agar plates shall be incubated for seventy-two (72) hours.
       5. 5. Drug Testing - Beta lactam test methods which have been independently evaluated or evaluated by FDA and have been found acceptable by FDA and the NCIMS for detecting Beta lactam drug residues in raw milk, or pasteurized milk, or a particular type of pasteurized milk product at current target testing or tolerance levels, shall be used for each Beta lactam drug of concern. This does not apply to those milk products for which there are not any approved Beta lactam test methods available (refer to M-a-85, latest revision, for the approved Beta lactam test methods and M-a-98, latest revision, for the specific milk and/or milk product for which there are approved Beta lactam test methods available). Enforcement action shall be taken on all confirmed positive Beta lactam results (refer to Appendix N). A result shall be considered confirmed positive for Beta lactams if it has been obtained by using a test method, which has been evaluated and deemed acceptable by FDA and accepted by the NCIMS at levels established in memoranda transmitted periodically by FDA (refer to Appendix N, IV).
       6. 6. Screening and Confirmatory Methods for the Detection of Abnormal Milk - The results of the screening test or confirmatory test shall be recorded on the official records of the dairy farm and a copy of the results sent to the milk producer.

       7. 7. When a warning letter has been sent, because of excessively high somatic cell counts, an official inspection of the dairy farm should be made by regulatory personnel or certified industry personnel. This inspection should be made during milking time.

          1. (i) Milk (Non-Goat) - Any of the following confirmatory or screening test procedures shall be used: Single Strip Direct Microscopic Somatic Cell Count (DMSCC) or Electronic Somatic Cell Count (ESCC).
          2. (ii) Goat Milk - DMSCC or ESCC may be used for screening raw goat milk samples, to indicate a range of somatic cell levels, as long as the somatic cell standard for goat milk remains 1,500,000/mL. Screening for official purposes shall be conducted by an analyst (s) certified for that procedure.
          3. (iii) Only the Pyronine Y-Methyl Green stain or “New York modification” Single Strip DMSCC test procedures shall be used to confirm the level of somatic cells in goat milk by certified analysts.
          4. (iv) Sheep Milk - Any of the following confirmatory or screening test procedures shall be used: Single Strip DMSCC or ESCC. When results from the Single Strip DMSCC procedure exceed the 750,000/mL standard set forth in this rule, the count shall have been derived from, or be confirmed by, the Pyronine Y Methyl-Green Stain or the “New York modification.”
          5. (v) Camel Milk - Any of the following confirmatory or screening test procedures shall be used: Single Strip DMSCC or ESCC. When results exceed the 750,000/mL standard set forth in this rule, the count shall have been derived from, or be confirmed by, the Single Strip DMSCC using the Pyronine Y Methyl-Green Stain or the "New York modification,” and conducted by analysts certified for that procedure (refer to the Note: on page 35).
       8. 8. Electronic Phosphatase Tests - The phosphatase test is an index of the efficiency of the pasteurization process. In the event an accredited laboratory finds that a sample confirms positive for phosphatase, the pasteurization process shall be investigated and corrected. When a laboratory phosphatase test is confirmed positive, or if any doubt should arise as to the compliance of the equipment, standards, or methods outlined in Rule 420-3-16-.10(1)(a) the Health Officer should immediately conduct field phosphatase testing at the milk plant (refer to Appendix G).
       9. 9. Vitamin testing shall be performed using test methods acceptable to FDA or other official methodologies, which give statistically equivalent results to the FDA methods.
       10. 10. Any other tests, which have been approved by FDA to be equally accurate, precise, and practical.
       11. 11. All standards used in the development and use of drug residue detection methods designed for the PMO monitoring programs shall be referenced to a United States Pharmacopeia (USP) standard when available. When a USP standard is not available, then the original method shall define the standard to be used.
       12. 12. Procedural or reagent changes for official tests shall be submitted to FDA for acceptance prior to being used by certified NCIMS milk laboratories.

       13. 13. Sampling Procedures - SMEDP contains guidance for the sampling of milk, milk products, and frozen dessert products. Optionally, sample collection time may be identified in military time (24 hour clock) (refer to Appendix G for a reference to drug residues in milk, milk products, and frozen dessert products and the conditions under which a positive phosphatase reaction may be encountered in properly pasteurized milk or cream), (refer to Appendix B for reference to farm bulk milk hauling programs regarding training, licensing/permitting, routine inspection, and the evaluation of sampling procedures).

           1. (i) When samples of raw milk for pasteurization, ultra-pasteurization, aseptic processing and packaging, or retort processed after packaging are taken at a milk or frozen dessert plant prior to pasteurization, ultra-pasteurization, aseptic processing and/or retort processing, respectively, they shall be drawn following adequate agitation from randomly selected storage tanks/silos. All counts and temperatures shall be recorded on a milk-ledger form as soon as reported by the laboratory. A computer or other information retrieval system may be used.
           2. (ii) When bacterial counts except for aseptically processed milk and milk products, and temperature determinations are made of several samples of the same milk or milk products collected from the same supply or processor on the same day, these values are averaged arithmetically, and the results recorded as the count or temperature determinations of the milk or milk product for that day. All counts and
              temperatures should be recorded on a milk ledger form for dairy farms or milk plants as soon as reported by the laboratory.
           3. (iii) A computer of other information retrieval system may be used.

           4. (iv) See Appendix G for a reference to antibiotics in milk and the conditions under which a positive phosphatase reaction may be encountered in properly pasteurized milk or cream.

              Note: Milk from animals not currently in the PMO may be labeled as Grade “A” and IMS listed upon FDA’s acceptance of validated the PMO, Section 6, 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).

       14. 14. Farm Bulk Milk Hauling - The farm bulk milk hauler occupies a unique position in the producer/processor/ Health Officer relationship. The milk hauler is a critical factor in the current structure of milk marketing. As a weigher and sampler, he/she stands as the official and, frequently, the only judge of milk volumes bought and sold. As the milk receiver, the hauler's operating habits directly affect the quality of milk committed to his/her care. When the bulk milk hauler's obligations include the collection and delivery of samples to the laboratory for analysis, he/she becomes a vital part of the quality control and regulatory programs. Any deviation from acceptable practices by the milk hauler may result in the suspension and/or revocation of his/her permit (see Appendix B for reference to farm milk hauling program regarding training, licensing, permitting, routine inspection, and the evaluation procedure).

           Note: The industry should be encouraged by the Health Officer to achieve day-to-day compliance with the foregoing standards by performing tests on each producer's milk, including platform tests for odors, temperature, and sediment. Bacterial counts should be conducted following laboratory pasteurization as a check for thermoduric organisms. Examinations for the presence of phychro-philic bacteria are also recommended. Periodic screening tests for presence of added water, antibiotics, and pesticide residues should be performed on producer’s milk. Plants should reject milk of abnormal odor and high temperature, as well as milk that is found to be unsatisfactory by the sediment test. Follow-up inspection on the dairy farm should be made by the field man to determine the cause and to institute corrective measures whenever milk is rejected by the plant.

Author: G. M. Gallaspy, Jr.

Statutory Authority: Code of Ala. 1975, §§22-2-2, 22-20-7.

History: Repealed and New Rule: Filed October 18, 2018; effective December 2, 2018.