[39 Pa.B. 4677]
[Saturday, August 1, 2009]
[Continued from previous Web Page] § 59a.18. Sampling and examination.
(a) Sampling and testing costs. Sampling and testing required under this section shall be at the expense of the permitholder or permit applicant, and shall be conducted by a Pennsylvania-approved dairy laboratory or the Department.
(b) Certified milk plants, receiving stations and transfer stations; milk plants and transfer stations that receive Grade ''A'' milk. A milk plant, receiving station or transfer station shall comply with Appendix N of the Grade ''A'' PMO, regarding drug residue testing and farm surveillance, if it is certified under the NCIMS Interstate Milk Shippers Program, or if it receives Grade ''A'' milk.
(c) Noncertified milk plants and transfer stations. Milk plants that are not certified under the NCIMS Interstate Milk Shippers Program, and which do not receive Grade ''A'' milk, shall obtain a representative sample of commingled milk for pasteurization each processing day. The sample shall be collected by certified industry plant sampler and analyzed for Beta lactam drug residues in an approved laboratory.
(d) Drug residue testing. Drug residue screening shall be completed at the direction of the Department and records of the testing shall be maintained on file by the permitholder.
(e) Reference to applicable provisions of the Grade ''A'' PMO. The provisions of the Grade ''A'' PMO and, in particular, section 6 and Appendix N of that document, regarding examination of milk and milk products, and drug residue testing and farm surveillance, respectively, apply to this section, to the extent described in § 59a.11 (relating to adoption of Grade ''A'' PMO).
§ 59a.19. Standards for grade ''A'' raw milk for pasteurization, ultrapasteurization or aseptic processing.
(a) Applicability. The standards prescribed under this section apply to a dairy farm that produces milk for pasteurization, ultrapasteurization or aseptic processing regardless of whether the dairy farm is certified under the NCIMS Interstate Milk Shippers Program.
(b) Reference to applicable provisions of the Grade ''A'' PMO. The provisions of the Grade ''A'' PMO and, in particular, the Standards for Grade ''A'' Raw Milk for Pasteurization, Ultrapasteurization or Aseptic Processing set forth in that document and section 7 of the Grade ''A'' PMO, regarding standards for Grade ''A'' milk and milk products, are incorporated by reference as regulations authorized under the act, to the extent they do not conflict with the act or any provision of this chapter. This includes all of the items listed under the referenced Grade ''A'' PMO provisions, including the following:
(1) Item 1r. Abnormal milk
(2) Item 2r. Milking Barn, Stable or Parlor--Construction
(3) Item 3r. Milking Barn, Stable or Parlor--Cleanliness
(4) Item 4r. Cowyard
(5) Item 5r. Milkhouse--Construction and Facilities
(6) Item 6r. Milkhouse--Cleanliness
(7) Item 7r. Toilet
(8) Item 8r. Water Supply, with the additional requirement that a plate heat exchanger or tubular cooler installed and in use on a dairy farm shall be equipped with an appropriate backflow prevention device
(9) Item 9r. Utensils and Equipment--Construction
(10) Item 10r. Utensils and Equipment--Cleaning
(11) Item 11r. Utensils and Equipment--Sanitization
(12) Item 12r. Utensils and Equipment--Storage
(13) Item 13r. Milking--Flanks, Udders and Teats
(14) Item 14r. Protection from Contamination
(15) Item 15r. Drug and Chemical Control
(16) Item 16r. Personnel--Handwashing Facilities
(17) Item 17r. Personnel--Cleanliness
(18) Item 18r. Raw Milk Cooling, with the exception that raw milk for pasteurization shall be cooled to 4° C (40° F) within 2 hours after completion of milking, and shall be delivered to the plant within 72 hours of the initial milking
(19) Item 19r. Insect and Rodent Control
§ 59a.20. Standards for grade ''A'' pasteurized, ultrapasteurized and aseptically processed milk and milk products.
(a) Reference to applicable provisions of the Grade ''A'' PMO. The provisions of the Grade ''A'' PMO and, in particular, the Standards for Grade ''A'' Pasteurized, Ultrapasteurized and Aseptically Processed Milk and Milk Products, and section 7 of the Grade ''A'' PMO, regarding standards for Grade ''A'' milk and milk products, apply to this section, to the extent described in § 59a.11 (relating to adoption of Grade ''A'' PMO). This includes all of the Items listed under the referenced Grade ''A'' PMO provisions, including the following:
(1) Item 1p. Floors--Construction
(2) Item 2p. Walls and Ceilings--Construction
(3) Item 3p. Doors and Windows
(4) Item 4p. Lighting and Ventilation
(5) Item 5p. Separate Rooms
(6) Item 6p. Toilet-Sewage Disposal Facilities
(7) Item 7p. Water Supply
(8) Item 8p. Handwashing Facilities
(9) Item 9p. Milk Plant Cleanliness
(10) Item 10p. Sanitary Piping
(11) Item 11p. Construction and Repair of Containers and Equipment
(12) Item 12p. Cleaning and Sanitizing of Containers and Equipment
(13) Item 13p. Storage of Cleaned Containers and Equipment
(14) Item 14p. Storage of Single-Service Containers, Utensils and Materials
(15) Item 15p. Protection from Contamination
(16) Item 16p. Pasteurization and Aseptic Processing
(17) Item 17p. Cooling of Milk and Milk Products
(18) Item 18p. Bottling, Packaging and Container Filling
(19) Item 19p. Capping, Container Closure and Sealing and Dry Milk Product Storage
(20) Item 20p. Personnel--Cleanliness
(21) Item 21p. Vehicles
(22) Item 22p. Surroundings
(b) Applicability. The standards prescribed under this section apply to a milk plant regardless of whether it is certified under the NCIMS Interstate Milk Shippers Program.
§ 59a.21. Standards.
(a) Standards for milk and PMO-defined milk products. The standards that apply to milk and PMO-defined milk products are as set forth in section 7 of the Grade ''A'' PMO, in Table 1, regarding chemical, physical, bacteriological, and temperature standards.
(b) Standards for milk for manufacturing and manufactured dairy products. The standards that apply to milk for manufacturing and manufactured dairy products are as set forth in Subchapter C (relating to production and processing of milk for manufacturing purposes). Other fluid derivatives of milk, including condensed milk and milk products, nonfat dry milk and milk products, condensed whey and whey products, and buttermilk and buttermilk products, may be processed according to the standards and requirements for manufactured grade milk and milk products provided that they meet all applicable requirements of Subchapter C.
(c) Standards for ice cream and frozen dessert mixes. Frozen desserts--vanilla, chocolate, and one other flavor when applicable--shall be tested at least monthly for the standard plate count and coliform group. Frozen desserts mix shall be tested at least monthly for the standard plate count, coliform group, and phosphatase activity. The following are the specific standards for ice cream and frozen dessert mixes:
(1) Temperature. Cooled to 45° F (7° C) or less and maintained thereat.
(2) Bacterial limits applicable to all but cultured products. 50,000 per gram.
(3) Coliform. Not to exceed 10 per gram. When fruit or nuts and flavoring are added after pasteurization, the count shall not exceed 20 per gram.
(4) Phosphatase. Less than 350 milliunits per liter by approved electronic phosphatase procedures.
(d) Reference to applicable provisions of the Grade ''A'' PMO. The provisions of the Grade ''A'' PMO and, in particular, section 7 and Appendix N of that document regarding examination of milk and milk products and drug residue testing and farm surveillance, respectively, apply to this section, to the extent described in § 59a.11 (relating to adoption of Grade ''A'' PMO).
§ 59a.22. Animal health.
The provisions of the Grade ''A'' PMO and, in particular, section 8 of that document, regarding animal health, apply to this section, to the extent described in § 59a.11 (relating to adoption of Grade ''A'' PMO).
§ 59a.23. Milk and milk products which may be sold.
The provisions of the Grade ''A'' PMO and, in particular, section 9 of that document, regarding milk and milk products which may be sold, apply to this section, to the extent described in § 59a.11 (relating to adoption of Grade ''A'' PMO).
§ 59a.24. Transferring; delivery containers; cooling.
The provisions of the Grade ''A'' PMO and, in particular, section 10 of that document, regarding transferring; delivery; containers; cooling, apply to this section, to the extent described in § 59a.11 (relating to adoption of Grade ''A'' PMO).
§ 59a.25. Milk, milk products and manufactured dairy products from points outside this Commonwealth.
(a) General requirement. Milk, milk products and manufactured dairy products originating from outside this Commonwealth may be sold in this Commonwealth if they are produced and pasteurized, ultrapasteurized, or aseptically processed, concentrated (condensed) or dried under regulations which are substantially equivalent to the Grade ''A'' PMO and one or more of the following apply:
(1) The products have been awarded acceptable Milk Sanitation Compliance and Enforcement Ratings by a Milk Sanitation Rating Officer certified by FDA.
(2) The products have been awarded a satisfactory HACCP listing, under a HACCP Program as specified in Appendix K of the Grade ''A'' PMO.
(3) The products originate from a country that the FDA has, following consultation with NCIMS, determined to have in place a public health regulatory program and government oversight of that program that have an equivalent effect on the safety of regulated milk or milk products, or both.
(4) The products are USDA-approved manufactured dairy products.
(5) The products have a Department-issued milk permit.
(b) Reference to applicable provisions of the Grade ''A'' PMO. The provisions of the Grade ''A'' PMO and, in particular, section 11 of that document, regarding milk and milk products from points beyond the limits of routine inspection, apply to this section, to the extent described in § 59a.11 (relating to adoption of Grade ''A'' PMO).
§ 59a.26. Plans for construction and reconstruction.
(a) Specific requirements. Properly prepared plans for all transfer stations, receiving stations, and milk plants regulated under this chapter which are constructed, reconstructed, or extensively altered shall be submitted to the Secretary for written approval before work is begun. Plans must likewise be approved before construction or extensive modification of a manure storage system; installation of a bulk milk storage tank; installation of a milk transfer system on a dairy farm; or installation of milk handling equipment in a transfer station, receiving station, or milk plant.
(b) Reference to applicable provisions of the Grade ''A'' PMO. The provisions of the Grade ''A'' PMO and, in particular, section 12 of that document, regarding plans for construction and reconstruction, apply to this section, to the extent described in § 59a.11 (relating to adoption of Grade ''A'' PMO).
§ 59a.27. Personnel health.
(a) Specific requirements. A person affected with any disease in a communicable form or while a carrier of the disease may not work at any dairy farm or milk plant in any capacity which brings the person into contact with the production, handling, storage or transportation of milk, milk products, containers, equipment and utensils; and a dairy farm or milk plant operator may not employ in any capacity a person suspected of having a disease in a communicable form, or a person suspected of being a carrier of the disease. A producer or distributor of milk or milk products upon whose dairy farm or in whose milk plant a communicable disease occurs or who suspects that an employee has contracted any disease in a communicable form or has become a carrier of the disease shall notify the Department immediately.
(b) Reference to applicable provisions of the Grade ''A'' PMO. The provisions of the Grade ''A'' PMO and, in particular, section 13 of that document, regarding personnel health, apply to this section, to the extent described in § 59a.11 (relating to adoption of Grade ''A'' PMO).
§ 59a.28. Procedure when infection or high risk of infection is discovered.
(a) Specific requirements. When reasonable cause exists to suspect the possibility of transmission of infection from a person concerned with the handling of milk or milk products, the Department is authorized to require one or more of the following measures:
(1) The immediate exclusion of that person from handling milk or milk products, or the handling of related milk or milk-product contact surfaces, subject to release from this exclusion if in accordance with Table 5 of section 15 of the Grade ''A'' PMO.
(2) The immediate exclusion of the milk supply concerned from distribution and use.
(3) Adequate medical and bacteriological examination of the person and his associates and of their body discharges.
(b) Reference to applicable provisions of the Grade ''A'' PMO. The provisions of the Grade ''A'' PMO and, in particular, section 16 of that document, regarding procedure when infection or high risk of infection is discovered, apply to this section, to the extent described in § 59a.11 (relating to adoption of Grade ''A'' PMO).
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--weigher/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. § 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 Program, 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 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.
§ 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--weigher/samplers.
Weighers/samplers will be evaluated and approved by the Department.
§ 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 (relating to basis).
§ 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.
§ 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 an acceptable test procedure. The milk may not show any abnormal condition including curdles, ropy, bloody or mastitic conditions, as indicated by sight or other test procedures. 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.
§ 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.
§ 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.
(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 Pennsylvania-approved dairy laboratory shall do the following:
(1) Provide the producer with a warning of the excessive bacterial estimate. This warning need not be written.
(2) Notify the Department and provide the producer a written warning notice if two of the last four consecutive bacterial estimates exceed 500,000 per milliliter. The notice must be in effect so long as two of the last four consecutive samples exceed 500,000 per milliliter.
(d) Excluding milk with excessive bacteria 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 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.
§ 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.
(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, the Pennsylvania-approved dairy laboratory shall do the following:
(1) Provide the producer with a warning of the excessive somatic cell count.
(2) Notify the Department and provide the producer a written warning notice if two of the last four consecutive somatic cell counts exceed 750,000 per milliliter. The notice must be in effect so long as two of the last four consecutive samples exceed 750,000 per milliliter.
(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.
§ 59a.111. Drug residue level.
(a) Industry responsibilities.
(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.
(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.
(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.
(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.
(3) Load sampling and testing.
(i) Bulk milk. A load sample shall be taken from the bulk milk pickup tanker 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.
(iii) Producer/processor. A load sample shall be formed at the plant using a sampling procedure that includes all milk produced and received.
(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 12 months.
(5) Industry follow-up.
(i) When a load sample tests positive for drug residue, industry personnel 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 Department will initiate administrative procedures to suspend the producer's milk shipping privileges according to State policy.
(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.
§ 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, 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 following shall occur:
(1) The dairy farm shall be inspected by an approved inspector and have a passing score before milk is shipped.
(2) The new buyer shall do one of the following:
(i) Obtain quality control records from the previous buyer for the previous 12-month period to confirm from these records that the following conditions are met:
(A) The milk is currently classified ''acceptable'' for sediment.
(B) Three of the last five consecutive milk samples do not exceed the maximum bacterial estimate.
(C) Three of the last five consecutive milk samples do not exceed the maximum somatic cell count level requirements.
(D) The last shipment of milk received from the producer by the former plant did not test positive for drug residue.
(E) Milk shipments currently are not excluded from the market due to a positive drug residue test.
(ii) Examine and classify each transfer producer's first shipment of milk in accordance with subsection (b), and subsequently examine shipments with subsection (c).
(3) When a producer discontinues milk delivery at one plant and begins delivery at another plant for any reason, the new buyer may not accept the first milk delivery until he has requested from the previous buyer a copy of the record of the following:
(i) The producer's milk quality tests covering the preceding 12 months.
(ii) The producer's drug residue test results for the preceding 12 month period.
(iii) A copy of the current Dairy Farm Inspection Report.
(4) The previous buyer shall furnish the new buyer with the information within 24 hours after receipt of the request. A new buyer may accept a transfer producer's milk after making the request for records, but before receiving them, if the new buyer first confirms the producer's records verbally from the previous buyer. If verbal communication is used to ascertain the status of quality records, the new buyer shall send to the previous buyer, as soon as possible, a written confirmation of the conversation.
(5) If the new buyer fails to receive the quality records from the previous buyer, the new buyer shall report this fact to the Department.
§ 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 at least 12 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 recyled animal body discharges. Poultry litter and recycled animal body discharges may not be fed to lactating dairy animals.
§ 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 area, an accredited free state or an accredited free herd as determined by the United States Department of Agriculture. If the animals are not located in those areas, they shall be tested annually under the jurisdiction of that 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 meeting Class B status, or Certified-Free Herds, 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 or from herds 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.
Subchapter D. FARMS PRODUCING MILK FOR MANUFACTURING Sec.
59a.201. Farm inspection. 59a.202. Milking facilities and housing. 59a.203. Milking procedures. 59a.204. Cooling and storage. 59a.205. Milkhouse or milkroom. 59a.206. Utensils and equipment. 59a.207. Water supply. 59a.208. Sewage disposal. § 59a.201. Farm inspection.
Farms producing and selling milk for manufacturing purposes shall comply with the following inspection provisions:
(1) Each dairy farm operated by a producer of milk for manufacturing purposes shall be inspected initially and on any change of market by an approved inspector and shall have a passing score before the first milk is shipped. Dairy farms producing milk for manufacturing purposes shall be inspected at least once in each 6 month period by an approved inspector, and an accurate record of inspections shall be maintained by each permitholder on forms acceptable to the Secretary.
(2) Producers who cannot produce milk of a wholesome sanitary quality will be suspended. Producers who are not in substantial compliance with this section or § 59a.102 (relating to milk permits) will be reinspected after an appropriate time for correction of deficiencies.
(3) A permitholder shall promptly notify the Department of initial instatement, suspension or reinstatement of a producer from which milk for manufacturing is or was received. Identification of the producer, including name and address, shall be provided orally or by mail within 24 hours of the action.
§ 59a.202. Milking facilities and housing.
(a) General requirements. A milking barn or milking parlor of adequate size and arrangement shall be provided to permit normal sanitary milking operations. It shall be well lighted and ventilated, and the floors and gutters in the milking area shall be constructed of concrete or other impervious material. The facility shall be kept clean, the manure removed daily and stored to prevent access of lactating animals to accumulation thereof. Swine or fowl may not be permitted in the milking area. When a milking barn is used and horses are present, the horses shall be stalled in a separate area a sufficient distance from the milking area or separated by tight partitions.
(b) Platforms and ramps. If a milking barn or milking parlor has ramps and platforms that are used to elevate lactating animals, these ramps and platforms must be constructed of an impervious material such as steel. Wooden platforms and ramps are prohibited. Rubber mats may be used as long as they are not placed over a wooden platform.
(c) Concentrates and feed storage. Concentrates and feed, if stored in the building, shall be stored in a tightly covered box, bin or container.
(d) Protection of exposed milk. If milk is exposed during straining or transferring in the milking area, it shall be protected from falling particles from areas above the milk facility.
(e) Yard requirements. The yard or loafing area must be of ample size to prevent overcrowding, be drained to prevent forming of standing water pools, insofar as practicable, and kept clean.
§ 59a.203. Milking procedures.
(a) Cleanliness of udders and flanks. The udders and flanks of all lactating animals shall be kept clean. The udders and teats shall be washed or wiped immediately before milking with a clean, damp cloth or paper towel moistened with a sanitizing solution and wiped dry or by another sanitary method approved in writing by the Department.
(b) Milker. The milker's outer clothing must be clean and his hands clean and dry. A person with an infected cut or open sores on the person's hands or arms may not milk lactating animals, or handle milk or milk containers, utensils or equipment.
(c) Equipment. Milk stools, surcingles or antikickers shall be kept clean and properly stored. Dusty operations may not be conducted immediately before or during milking. Strong flavored feeds may not be fed immediately before or during milking.
(d) Abnormal milk. In addition to the requirements of § 59a.116 (relating to abnormal milk), abnormal milk may not be squirted on the floor, on the platform or in the producer's hand. Producers shall also wash their hands after handling equipment and handling the teats and udders of animals producing abnormal milk.
§ 59a.204. Cooling and storage.
(a) Milk in cans. Milk in cans shall be cooled immediately after milking to 50° F or lower at the farm, and not exceed 55° F upon delivery to the plant, unless delivered to the plant within 2 hours after milking. The cooler, tank or refrigerated unit shall be kept clean. Maximum time of delivery of milk to a milk plant shall be within 48 hours of initial milking.
(b) Milk in farm bulk tanks. Milk in farm bulk tanks shall be cooled to 40° F within 2 hours after milking. Cooled milk may not be allowed to rise above a temperature of 50° F by subsequent addition of milk to the bulk tank and shall be cooled at 45° F or lower at time of pick-up, and not exceed 50° F upon delivery to the plant. Maximum time of delivery of milk to a milk plant may not exceed 72 hours of initial milking.
§ 59a.205. Milkhouse or milkroom.
(a) General requirements. A milkhouse or milkroom shall be provided for handling and cooling milk and for washing, handling and storing the utensils and equipment. The milkhouse or milkroom must be conveniently located and properly constructed, lighted and ventilated. Other products may not be handled in the milkroom which would be likely to contaminate milk, or otherwise create a public health hazard.
(b) Equipment and construction. The milkroom must be equipped with a wash and rinse vat, utensil rack, milk cooling facilities and an adequate supply of hot water available for cleaning milking equipment. If a part of the barn or other building, it must be partitioned, screened and sealed to prevent the entrance of dust, flies or other contamination. The floor of the building must be of concrete or other impervious material and graded to provide proper drainage. The walls and ceilings must be constructed of smooth easily cleaned material. Outside doors must open outward and be self-closing, unless they are provided with tight-fitting screen doors that open outward or unless other effective means are provided to prevent the entrance of flies.
(c) Farm bulk tanks. If a farm bulk tank is used, the following requirements apply:
(1) The farm bulk tank shall be properly located in the milkhouse or milkroom for access to all areas for cleaning and servicing. It may not be located over a floor drain or under a ventilator.
(2) A small platform or slab constructed of concrete or other impervious material shall be provided outside the milkhouse, properly centered under a suitable port opening in the wall of the milkhouse. The opening shall be fitted with a tight, self-closing door. The truck approach to the milkhouse or milkroom must be properly graded and surfaced to prevent mud or pooling of water at the point of loading.
(d) Trash, animals and fowl. The milkhouse or milkroom and appurtenances shall be kept clean and free of trash, animals and fowl.
(e) Farm chemicals and animal drugs.
(1) Animal biologics and other drugs intended for treatment of animals, and insecticides approved for use in dairy operations, must be clearly labeled and used in accordance with label instructions, and stored in a manner which will prevent accidental contact with milk and milk contact surfaces.
(2) Only drugs that are approved by the FDA or biologics approved by the United States Department of Agriculture (USDA) for use in dairy animals that are properly labeled according to FDA or USDA regulations shall be administered to the animals.
(3) When drug storage is located in the milkroom, milkhouse or milking area, the drugs shall be stored in a closed, tight-fitting storage unit. The drugs shall further be segregated so that drugs labeled for use in lactating dairy animals are separated from drugs labeled for use in nonlactating dairy animals.
(4) Drugs labeled for use in nondairy animals may not be stored with drugs labeled for use in dairy animals. When drugs labeled for use in nondairy animals are stored in the barn, the drugs shall be located in an area of the barn separate from the milking area.
(5) Herbicides, fertilizers, pesticides and insecticides that are not approved for use in dairy operations may not be stored in the milkhouse, milkroom or milking area.
§ 59a.206. Utensils and equipment.
(a) General requirements. Utensils, milk cans, milking machines--including pipeline systems--rubber and rubber like parts and other equipment used in the handling of milk shall be maintained in good condition, be free from rust, open seams, milkstone or any unsanitary condition, and shall be washed, rinsed and drained after each milking, stored in suitable facilities, and sanitized immediately before use with a dairy equipment sanitizer that has been approved by the Environmental Protection Agency for use with dairy or food processing equipment, and that is used according to the label directions. New or replacement can lids must be umbrella type. New utensils and equipment must comply with applicable 3-A Sanitary Standards.
(b) Farm bulk tanks. Farm bulk tanks must meet 3-A Sanitary Standards for construction at the time of installation and be installed under § 59a.26 (relating to plans for construction and reconstruction).
(c) Single service articles. Single service articles shall be properly stored and may not be reused.
§ 59a.207. Water supply.
A dairy farm water supply shall be properly located, protected and operated, and shall be easily accessible, ample, and of safe, sanitary quality for the cleaning of dairy utensils and equipment. The water supply must come from a source which is approved by the Department; or from a spring, dug well, driven well, bored well, or drilled well, the water from which complies with the standards of the Department.
§ 59a.208. Sewage disposal.
House, milkhouse or milkroom and toilet wastes shall be disposed of in a manner that will not pollute the soil surface, contaminate the water supply or be conducive to the breeding of insects.
Subchapter E. MANUFACTURING PLANTS
GENERAL REQUIREMENTS Sec.
59a.301. Premises. 59a.302. Buildings. 59a.303. Facilities. 59a.304. Equipment and utensils. 59a.305. Personnel cleanliness. 59a.306. Personnel health. 59a.307. Protection and transport of raw milk and cream. 59a.308. Raw product storage. 59a.309. Pasteurized, ultrapasteurized or aseptically processed and packaged products. 59a.310. Composition and wholesomeness. 59a.311. Cleaning and sanitizing treatment. 59a.312. Insect and rodent control program. 59a.313. Plant records. 59a.314. Packaging and general identification. 59a.315. Storage of finished product. 59a.316. Permits.
SUPPLEMENTAL REQUIREMENTS FOR PLANTS MANUFACTURING, PROCESSING AND PACKAGING INSTANT NONFAT DRY MILK, NONFAT DRY MILK, DRY WHOLE MILK, DRY BUTTERMILK, DRY WHEY AND OTHER DRY MILK PRODUCTS 59a.321. Requirements for rooms and compartments.
59a.322. Dry storage. 59a.323. Packaging room for bulk products. 59a.324. Hopper or dump room. 59a.325. Repackaging room. 59a.326. Equipment and utensils. 59a.327. Preheaters. 59a.328. Hotwells. 59a.329. Evaporators or vacuum pans, or both. 59a.330. Surge tanks. 59a.331. High pressure pumps and lines. 59a.332. Dryers. 59a.333. Collectors and conveyors. 59a.334. Dry dairy product cooling equipment. 59a.335. Special treatment equipment. 59a.336. Sifters. 59a.337. Portable and stationary bulk bins. 59a.338. Automatic sampling device. 59a.339. Dump hoppers, screens and mixers. 59a.340. Filler and packaging equipment. 59a.341. Heavy duty vacuum cleaners. 59a.342. Clothing and shoe covers. 59a.343. Operations and operating procedures: Pasteurization. 59a.344. Operations and operating procedures: Condensed surge supply. 59a.345. Operations and operating procedures: Condensed storage tanks. 59a.346. Operations and operating procedures: Drying. 59a.347. Operations and operating procedures: Cooling dry products. 59a.348. Operations and operating procedures: Packaging, repackaging and storage. 59a.349. Operations and operating procedures: Product adulteration. 59a.350. Operations and operating procedures: Checking quality. 59a.351. Operations and operating procedures: Requirements for instant nonfat dry milk. 59a.352. Operations and operating procedures: Cleaning of dryers, conveyors, sifters and storage bins. 59a.353 Operations and operating procedures: Insect and rodent control program.
SUPPLEMENTAL REQUIREMENTS FOR PLANTS MANUFACTURING, PROCESSING AND PACKAGING BUTTER AND RELATED PRODUCTS
59a.361. Rooms and compartments. 59a.362. Equipment and utensils. 59a.363. Operations and operating procedures.
SUPPLEMENTAL REQUIREMENTS FOR PLANTS MANUFACTURING AND PACKAGING CHEESE
59a.371. Rooms and compartments. 59a.372. Equipment and utensils. 59a.373. Operations and operating procedures.
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