Subchapter C. PRODUCTION AND PROCESSING OF MILK FOR MANUFACTURING PURPOSES
Sec.
59a.101. Adoption of USDA recommended requirements.
59a.102. Milk permits.
59a.103. Plant inspection.
59a.104. Certification of bulk milk collectors-weighers/samplers.
59a.105. Approved milk graders.
59a.106. Basis.
59a.107. Appearance and odor.
59a.108. Sediment content classification.
59a.109. Bacterial estimate classification.
59a.110. Somatic cell count.
59a.111. Drug residue level.
59a.112. Rejected milk.
59a.113. Suspended milk for manufacturing.
59a.114. Inspection and quality testing of milk from producers.
59a.115. Record of tests.
59a.116. Abnormal milk.
59a.117. Animal health.
Cross References This subchapter C cited in 7 Pa. Code § 59a.21 (relating to standards); and 7 Pa. Code § 59a.201 (relating to farm inspection).
§ 59a.101. Adoption of USDA recommended requirements.
The provisions, terms, procedures and standards of the most current version of the publication of the United States Department of Agriculture, Agricultural Marketing Service, Dairy Programs, titled Milk for Manufacturing Purposes and its Production and Processing—Recommended Requirements, are adopted as the regulatory standards of the Department to the extent they do not conflict with one or more of the following:
(1) The act.
(2) The Food Safety Act.
(3) A provision of this subchapter.
§ 59a.102. Milk permits.
Plants, receiving stations, transfer stations and bulk tank units handling or processing milk for manufacturing of dairy products shall apply for a permit in accordance with § 59a.12 (relating to permits) which describes the process and requirements by which permits are acquired and maintained.
(1) Permits are required for the sale of milk for manufacturing purposes and manufactured dairy products. Application shall be made annually on a form secured from the Secretary.
(2) A separate permit shall be obtained for each plant, receiving station, transfer station and bulk tank unit.
(3) The permit year begins September 1 of each year and ends on August 31 of the following year.
Cross References This section cited in 7 Pa. Code § 59a.201 (relating to farm inspection).
§ 59a.103. Plant inspection.
Plants receiving milk or dairy products, for manufacturing or further processing, will be subject to inspection by the Secretary or an agent.
§ 59a.104. Certification of bulk milk collectors—weighers/samplers.
(a) Weighers/samplers will be evaluated and approved by the Department.
(b) The provisions of the Grade ‘‘A’’ PMO, in particular Appendix B, regarding the required training and periodic evaluation of weighers/samplers, apply to this section to the extent described in § 59a.11 (relating to adoption of Grade ‘‘A’’ PMO).
§ 59a.105. Approved milk graders.
Milk graders will be approved by the Department based upon the milk grader being capable of determining the quality classification of raw milk for manufacturing purposes in accordance with § § 59a.106—59a.111.
§ 59a.106. Basis.
The quality classification of raw milk for manufacturing purposes shall be based on an organoleptic examination for appearance and odor, a drug residue test and quality control tests for sediment content, bacterial estimate and somatic cell count.
Cross References This section cited in 7 Pa. Code § 59a.105 (relating to approved milk graders).
§ 59a.107. Appearance and odor.
The appearance of acceptable raw milk for manufacturing purposes must be normal and free of excessive coarse sediment when examined visually or by the methods described in § 59a.108(a) (relating to sediment content classification). The milk may not show any abnormal condition including curdles, ropy, bloody or mastitic conditions, as indicated by visual examination of the milk. The odor must be fresh and sweet. The milk must be free from objectionable feed and other off-odors that would adversely affect the finished product.
Cross References This section cited in 7 Pa. Code § 59a.105 (relating to approved milk graders); 7 Pa. Code § 59a.108 (relating to sediment content classification); 7 Pa. Code § 59a.112 (relating to rejected milk); and 7 Pa. Code § 59a.114 (relating to inspection and quality testing of milk from producers).
§ 59a.108. Sediment content classification.
(a) Method of testing. Methods for determining the sediment content of the milk of individual producers shall be those described in the Standard Methods for the Examination of Dairy Products. Sediment content must be based on comparison with applicable charts of the United States Sediment Standards for Milk and Milk Products. These charts are available from the Dairy Standardization Branch, Dairy Programs, Agricultural Marketing Service, United States Department of Agriculture, Room 2746-South, 1400 Independence Avenue, S.W., Washington, D.C. 20250-0230.
(b) Classifications. Milk shall be classified for sediment content in accordance with the USDA Sediment Standard, regardless of the results of the appearance and odor examination described in § 59a.107 (relating to appearance and odor), as set forth in this subsection. The USDA Sediment Standard defines the following classifications:
(1) Milk classified as ‘‘No. 1’’ has a tested sediment content that does not exceed 0.50 mg. or equivalent, and is acceptable.
(2) Milk classified as ‘‘No. 2’’ has a tested sediment content that does not exceed 1.50 mg. or equivalent, and is acceptable.
(3) Milk classified as ‘‘No. 3’’ has a tested sediment content that does not exceed 2.50 mg. or equivalent, and is probational for not more than 10 days.
(4) Milk classified as ‘‘No. 4’’ has a tested sediment content that exceeds 2.50 mg. or equivalent, and is rejected.
(c) Frequency of tests. At least once each month, at irregular intervals, the milk from each producer shall be tested as follows:
(1) Milk in cans. A sample shall be taken from one or more cans of milk selected at random from each producer.
(2) Milk in farm bulk tanks. A sample shall be taken from each farm bulk tank.
(d) Acceptance or rejection of milk.
(1) If the sediment disc is classified as No. 1, No. 2 or No. 3, the producer’s milk may be accepted.
(2) If the sediment disc is classified as No. 4, the milk shall be rejected.
(3) If the shipment of milk is commingled with other milk in a transport tank, the next shipment may not be accepted until its quality has been determined at the farm before being picked up. If the person making the test is unable to get to the farm before the next shipment, it may be accepted but no further shipments shall be accepted unless the milk meets the requirements of No. 3 or better. In the case of milk classified as No. 3 or No. 4, if in cans, all cans shall be tested. Producers of No. 3 or No. 4 milk-cans or bulk-shall be notified immediately and shall be furnished applicable sediment discs and the next shipment shall be tested.
(e) Retests. On tests of the next shipment (if in cans, all cans shall be tested) milk classified as No. 1, No. 2 or No. 3, may be accepted, but No. 4 milk shall be rejected. Retests of bulk milk classified as No. 4 shall be made at the farm before pickup. The producers of No. 3 or No. 4 milk shall be notified immediately, furnished applicable sediment discs and the next shipment shall be tested. This procedure of retesting successive shipments and accepting probational (No. 3) milk and rejecting No. 4 milk may be continued for a period not to exceed 10 calendar days. If, at the end of this time, all of the producer’s milk does not meet the acceptable sediment content classification (No. 1 or No. 2), it shall be excluded from market.
Cross References This section cited in 7 Pa. Code § 59a.105 (relating to approved milk graders); 7 Pa. Code § 59a.107 (relating to appearance and odor); 7 Pa. Code § 59a.113 (relating to suspended milk for manufacturing); and 7 Pa. Code § 59a.114 (relating to inspection and quality testing of milk from producers).
§ 59a.109. Bacterial estimate classification.
(a) General testing requirement. A laboratory examination to determine the bacterial estimate shall be made on each producer’s milk at least once each month at irregular intervals. Samples shall be analyzed at a Pennsylvania-approved dairy laboratory. The laboratory must report the results to the permitholder.
(b) Testing methods. Milk shall be tested for bacterial estimate by using one of the following methods or by any other method approved by the Standard Methods for the Examination of Dairy Products, and include the following:
(1) Direct microscopic clump count.
(2) Standard plate count.
(3) Plate loop count.
(4) BactoscanTM count.
(5) Pectin gel plate count.
(6) PetrifilmTM aerobic count.
(7) Spiral plate count.
(8) Hydrophobic grid membrane filter count.
(9) Impedance/conductance count.
(10) Other tests that have been approved by the Department through publication of notice in the Pennsylvania Bulletin.
(c) Excessive bacteria. Whenever the bacterial estimate indicates the presence of more than 500,000 bacteria per milliliter, the result shall be noted as a violation in the permitholder’s records. When two of the last four consecutive bacterial estimates exceed 500,000 per milliliter, the permitholder shall send a written warning notice to the producer in violation. This notice shall be in effect as long as two of the last four consecutive samples exceed the limit of the standard.
(d) Excluding milk with excessive bacteria from the market. If a producer receives the written notice described in subsection (c), the producer shall have an additional sample taken between 3 and 21 days after receiving the notice. If this sample also exceeds 500,000 per milliliter, subsequent milkings shall be excluded from the market until satisfactory compliance is obtained. Shipment may be resumed and a temporary status assigned to the producer by the Department when an additional sample of herd milk is tested and found satisfactory. The producer shall be assigned a full reinstatement status when three out of four consecutive bacterial estimates do not exceed 500,000 per milliliter. The samples shall be taken at a rate of not more than two per week on separate days within a 3-week period.
Cross References This section cited in 7 Pa. Code § 59a.105 (relating to approved milk graders); 7 Pa. Code § 59a.111 (relating to drug residue level); 7 Pa. Code § 59a.113 (relating to suspended milk for manufacturing); and 7 Pa. Code § 59a.114 (relating to inspection and quality testing of milk from producers).
§ 59a.110. Somatic cell count.
(a) General testing requirement. A laboratory examination to determine the level of somatic cells shall be made on each producer’s milk at least once each month. Samples shall be analyzed at a Pennsylvania-approved dairy laboratory. The laboratory must report the results to the permitholder.
(b) Testing methods. Milk shall be tested for somatic cell content by using one of the following procedures:
(1) Direct Microscopic Somatic Cell Count (Single Strip Procedure).
(2) Electronic Somatic Cell Count.
(3) Flow Cytometry/Opto-Electronic Somatic Cell Count.
(4) Membrane Filter DNA Somatic Cell Count.
(c) Excessive somatic cell count. Whenever the official test indicates the presence of more than 750,000 somatic cells per milliliter (1,500,000/ml for goat milk), the result shall be noted as a violation in the permitholder’s records. When two of the last four consecutive bacterial estimates exceed 750,000/ml (1,500,000/ml for goat milk), the permitholder shall send a written warning notice to the producer in violation. This notice shall be in effect as long as two of the last four consecutive samples exceed the limit of the standard.
(d) Excluding milk with an excessive somatic cell count from the market. If a producer receives the written notice described in subsection (c)(2), the producer shall have an additional sample taken between 3 and 21 days after receiving the notice. If this sample also exceeds 750,000 per milliliter, subsequent milkings shall be excluded from the market until satisfactory compliance is obtained. Shipment may be resumed and a temporary status assigned to the producer by the Department when an additional sample of herd milk is tested and found satisfactory. The producer shall be assigned a full reinstatement status when three out of four consecutive somatic cell count tests do not exceed 750,000 per milliliter. The samples shall be taken at a rate of not more than two per week on separate days within a 3-week period.
Cross References This section cited in 7 Pa. Code § 59a.105 (relating to approved milk graders); 7 Pa. Code § 59a.113 (relating to suspended milk for manufacturing); and 7 Pa. Code § 59a.114 (relating to inspection and quality testing of milk from producers).
§ 59a.111. Drug residue level.
(a) Industry responsibilities. Manufactured dairy products permitholders shall meet the requirements of this section to confirm their manufactured dairy products are free of violative drug residues.
(1) Sampling and testing program.
(i) Milk shipped for processing or intended to be processed on the farm where it was produced shall be sampled and tested, prior to processing, for beta lactam drug residue. Collection, handling and testing of samples shall be done according to procedures established by the Department in this section, and in accordance with Appendix N of the Grade ‘‘A’’ PMO, regarding drug residue testing and farm surveillance. If a person processes milk on the farm where it was produced and produces that milk in accordance with a written quality control program addressing the use of animal drugs at that dairy operation, that person may request a variance from the testing requirements of this subparagraph. The request shall be in writing and include a copy of the written quality control program. The Department may, on the basis of the request, issue a variance with respect to the requirements of this subparagraph. A variance issued under this subparagraph will be valid for no more than 1 year and may be renewed for additional periods of up to 1 year following the Department’s review of the quality control program and any on-farm inspections the Department deems necessary to determine whether a successor variance should be issued.
(ii) When so specified by the FDA, milk shipped for processing, or intended to be processed on the farm where it was produced, shall be sampled and tested, prior to processing, for other drug residues under a random drug sampling program. The random drug sampling program must include at least four samples collected in at least 4 separate months during any consecutive 6-month period.
(iii) When the Commissioner of the FDA determines that a potential problem exists with an animal drug residue or other contaminant in the milk supply, a sampling and testing program shall be conducted, as determined by the FDA. The testing shall continue until the Commissioner of the FDA determines with reasonable assurance that the potential problem has been remedied.
(iv) The dairy industry shall analyze samples for beta lactams and other drug residues by methods which have been independently evaluated or evaluated by the FDA and accepted by the FDA as effective to detect drug residues at current safe or tolerance levels. Safe and tolerance levels for particular drugs are established by the FDA.
(v) Sample test results for milk that does not test positive shall be recorded. The test result records shall be retained for 6 months.
(2) Individual producer sampling.
(i) Bulk milk. A milk sample for beta lactam drug residue testing shall be taken at each farm and include milk from each farm bulk tank. The sample shall be tested for beta lactam drug residues on the same monthly schedule as the bacterial estimate testing described in § 59a.109 (relating to bacterial estimate classification).
(ii) Can milk. A milk sample for beta lactam drug residue testing shall be formed separately at the receiving plant for each can milk producer included in a delivery, and shall be representative of all milk received from the producer. The sample shall be tested for beta lactam drug residues on the same monthly schedule as the bacterial estimate testing described in § 59a.109.
(iii) Producer/processor. A milk sample for beta lactam drug residue testing shall be formed separately according to subparagraphs (i) and (ii) for milk produced or received by a producer/processor. The sample shall be tested for beta lactam drug residues on the same monthly schedule as the bacterial estimate testing described in § 59a.109.
(3) Load sampling and testing.
(i) Bulk milk. A load sample shall be taken from the bulk milk pickup tanker and tested for beta lactam residues after its arrival at the plant and prior to further commingling.
(ii) Can milk. A load sample representing all of the milk received on a shipment shall be formed at the plant using a sampling procedure that includes milk from every can on the vehicle and tested for beta lactam residues.
(iii) Producer/processor. A daily load sample shall be formed at the plant using a sampling procedure that includes all milk produced and received at the plant that day and tested for beta lactam residues.
(4) Sample and record retention. A load sample that tests positive for drug residue shall be retained for at least 12 months. The records of all positive sample test results shall be retained for at least 24 months.
(5) Industry follow-up.
(i) When a load sample tests positive for drug residue, an employee or representative of the receiving plant shall notify the Department immediately of the positive test result and of the intended disposition of the shipment of milk containing the drug residue. Milk testing positive for drug residue shall be disposed of in a manner that removes it from the human or animal food chain, except when acceptably reconditioned under FDA compliance policy guidelines.
(ii) Each individual producer sample represented in the positive-testing load sample shall be individually tested as directed by the Department to determine the producer of the milk sample testing positive for drug residue. Identification of the producer responsible for producing the milk testing positive for drug residue, and details of the final disposition of the shipment of milk containing the drug residue, shall be reported immediately to the Department.
(iii) Milk shipment from the producer identified as the source of milk testing positive for drug residue shall cease immediately and may resume only after a sample from a subsequent milking does not test positive for drug residue.
(b) Responsibilities of the Department.
(1) Monitoring and surveillance. The Department will monitor the milk industry’s drug residue program by conducting unannounced onsite inspections to observe testing and sampling procedures and to collect samples for comparison drug residue testing. In addition, the Department will review industry records for compliance with drug residue program requirements. The review will seek to determine that the following conditions are met:
(i) Each producer is included in a routine, effective drug residue milk monitoring program utilizing methods evaluated and found acceptable by FDA to test samples for the presence of drug residue.
(ii) The Department receives prompt notification from industry personnel of each occurrence of a sample testing positive for drug residue, and of the identity of each producer identified as a source of milk testing positive for drug residue.
(iii) The Department receives prompt notification from industry personnel of the intended and final disposition of milk testing positive for drug residue, and that disposal of the load is conducted in a manner that removes it from the human or animal food chain, except when acceptably reconditioned under FDA compliance policy guidelines.
(iv) Milk shipment from a producer identified as a source of milk testing positive for drug residue completely and immediately ceases until a milk sample taken from the dairy herd does not test positive for drug residue.
(2) Enforcement.
(i) Any time milk is found to test positive for drug residue, the Department will immediately take action to suspend the producer’s milk shipping privileges to prevent the sale of milk from the producer shipping milk testing positive for drug residue.
(ii) The producer’s milk shipping privileges may be reinstated when a representative sample taken from the producer’s milk, prior to commingling with any other milk, is no longer positive for drug residue.
(iii) The penalty shall 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.
(iv) Whenever a drug residue test is positive, an investigation shall be made to determine the cause. Action shall be taken to prevent future occurrences.
(v) If a producer ships milk testing positive for drug residue three times within a 12-month period, the producer shall follow best management practices that include testing each shipment for drug residues prior to pick-up.
(vi) The actions and procedures of the Department will be in accordance with this chapter and Appendix N of the Grade ‘‘A’’ PMO, regarding drug residue testing and farm surveillance.
Cross References This section cited in 7 Pa. Code § 59a.105 (relating to approved milk graders); and 7 Pa. Code § 59a.114 (relating to inspection and quality testing of milk from producers).
§ 59a.112. Rejected milk.
(a) Rejection requirement. A plant shall reject specific milk from a producer if it fails to meet the requirements under § 59a.107 (relating to appearance and odor), if it is classified No. 4 for sediment content, or if it tests positive for drug residue.
(b) Tagging and coloring rejected milk. Rejected milk shall be identified with a reject tag and colored with harmless food coloring.
§ 59a.113. Suspended milk for manufacturing.
A plant may not accept milk from a producer if one of the following occurs:
(1) The producer’s initial milk shipment to a plant is classified as No. 3 for sediment content, as described in § 59a.108 (relating to sediment content classification).
(2) The milk has been in a probational (No. 3) sediment content classification for more than 10-calendar days.
(3) Three of the last five milk samples have exceeded the maximum bacterial estimate of 500,000 per milliliter, as described in § 59a.109 (relating to bacterial estimate classification).
(4) Three of the last five milk samples have exceeded the maximum somatic cell count level of 750,000 per milliliter (1,500,000/ml for goat milk), as described in § 59a.110 (relating to somatic cell count).
(5) The producer’s milk shipments to either the Grade ‘‘A’’ milk market or the manufacturing grade milk market are currently prohibited due to a positive drug residue test.
(6) The milk contains added water. For purposes of this requirement, samples analyzed for added water and found to have a freezing point above -0.525° F (0.508° C) shall be considered adulterated unless proven free of added water.
§ 59a.114. Inspection and quality testing of milk from producers.
(a) Inspections. Inspections shall be as follows:
(1) A dairy farm on which milk is produced for manufacturing purposes shall be inspected initially and have a passing score before the first milk is shipped.
(2) The dairy farm of a producer, on a change of market shall be inspected by an approved inspector and have a passing score before the first milk is shipped.
(3) Dairy farms shall be inspected at least once in each 6-month period by an approved inspector.
(b) Testing of first shipment. An examination and tests shall be made on the first shipment of milk from producers shipping milk to a plant for the first time or after a period of nonshipment. The milk must meet the following requirements:
(1) The requirements of § 59a.107 (relating to appearance and odor).
(2) The requirements of § 59a.108 (relating to sediment content classification).
(3) The requirements of § 59a.109 (relating to bacterial estimate classification).
(4) The requirements of § 59a.110 (relating to somatic cell count).
(5) The requirements of § 59a.111 (relating to drug residue level).
(c) Testing of subsequent shipments. For all shipments of milk not described in subsection (b), testing must meet the following requirements:
(1) The requirements of § 59a.107.
(2) The requirements of § 59a.108.
(3) The requirements of § 59a.109.
(4) The requirements of § 59a.110.
(5) The requirements of § 59a.111.
(d) Transfer producers. When a producer discontinues milk delivery to one plant and begins delivery to a different plant, the provisions of the Grade ‘‘A’’ PMO, in particular section 5, regarding certified industry inspection and change-of-market requirements, apply to the extent described in § 59a.11 (relating to adoption of Grade ‘‘A’’ PMO).
§ 59a.115. Record of tests.
Accurate records of the results of the milk quality and drug residue tests for each producer shall be kept on file for 24 months and be available for examination by the Department.
§ 59a.116. Abnormal milk.
(a) Certain milk to be excluded from human consumption. Cows which show evidence of the secretion of abnormal milk in one or more quarters based on bacteriological, chemical or physical examination and cows which have been treated with or have consumed chemical, medicinal or radioactive agents which are capable of being secreted in the milk in excess of any established limits and which may be deleterious to human health shall be milked last or with separate equipment and the milk may not be offered for sale for human consumption.
(b) Medicinal agents. Milk from cows being treated with medicinal agents may not be offered for sale for periods recommended by the attending veterinarian or as indicated on the package label of the medicinal agent.
(c) Pesticides. Milk from cows treated with or exposed to pesticides not approved for use on dairy cattle by the United States Environmental Protection Agency may not be offered for sale until the milk has been tested and found acceptable by the Secretary, in accordance with the procedures and standards set forth in Appendix N of the Grade ‘‘A’’ PMO, regarding drug residue testing and farm surveillance.
(d) Visibly abnormal milk and odorous milk. Bloody, stringy, off-color milk or milk abnormal in sight and odor shall be handled and disposed of to preclude the infection of other cows, and the contamination of the utensils.
(e) Equipment, utensils and containers. Equipment, utensils and containers used for handling of abnormal milk may not be used for the handling of milk to be offered for sale unless they are first effectively cleaned and sanitized.
(f) Poultry litter and recycled animal body discharges. Poultry litter and recycled animal body discharges may not be fed to lactating dairy animals.
Cross References This section cited in 7 Pa. Code § 59a.203 (relating to milking procedures).
§ 59a.117. Animal health.
(a) General health. Animals in the herd shall be maintained in a healthy condition, and shall be properly fed and kept.
(b) Tuberculin test. The lactating animals shall be located in a modified accredited state or zone, an accredited free state or zone, or an accredited free herd as determined by the United States Department of Agriculture under 9 CFR Part 77 (relating to tuberculosis). If the animals are not located in those areas or zones, they shall be tested annually in accordance with that United States Department of Agriculture program. Additions to the herd shall be from an area or from herds meeting those same requirements.
(c) Brucellosis test. The lactating animals shall be located in states or areas meeting Class B status, or Certified Brucellosis-Free Herds, as determined by the United States Department of Agriculture under 9 CFR Part 78 (relating to brucellosis) or shall be involved in a milk ring test program or blood testing program under the current USDA Brucellosis Eradication Uniform Methods and Rules. Additions to the herd shall be from a State, area or herd meeting these same requirements.
(d) Prohibition. Brucellosis and tuberculosis reactors disclosed shall be separated immediately from the milking herd. Milk from brucellosis or tuberculosis reactors may not be sold.
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