[41 Pa.B. 2540]
[Saturday, May 21, 2011]
[Continued from previous Web Page]
Subchapter B. PERMIT REQUIREMENTS tSec.
59a.11. Adoption of Grade ''A'' PMO. 59a.12. Permits. 59a.13. Adulterated or misbranded milk, milk products or manufactured dairy products. 59a.14. Labeling: Bottles, containers and packages of milk, milk products or manufactured dairy products. 59a.15. Labeling: Milk dating. 59a.16. Markings, sealing and documentation for vehicles containing milk and milk products. 59a.17. Inspection of dairy farms and milk plants. 59a.18. Sampling and examination. 59a.19. Standards for Grade ''A'' milk for pasteurization, ultrapasteurization or aseptic processing. 59a.20. Standards for Grade ''A'' pasteurized, ultrapasteurized and aseptically processed milk and milk products. 59a.21. Standards. 59a.22. Animal health. 59a.23. Milk and milk products which may be sold. 59a.24. Transferring; delivery containers; cooling. 59a.25. Milk, milk products and manufactured dairy products from points outside this Commonwealth. 59a.26. Plans for construction and reconstruction. 59a.27. Personnel health. 59a.28. Procedure when infection or high risk of infection is discovered. § 59a.11. Adoption of Grade ''A'' PMO.
(a) General adoption of the Grade ''A'' PMO. The provisions, terms, procedures, appendices and standards of the Grade ''A'' PMO 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 chapter.
(b) Specific references to applicable provisions of the Grade ''A'' PMO. The provisions of this chapter contain, as guidance, references to the applicable provisions of the Grade ''A'' PMO.
§ 59a.12. Permits.
(a) Permit required. A person may not sell milk, milk products or manufactured dairy products within this Commonwealth without having a current, valid permit from the Secretary, unless the person is exempt from this permit requirement under subsection (b). A separate permit shall be obtained for each milk plant, milk distributor, receiving station, transfer station, bulk tank unit and milk tank truck cleaning facility, and by every producer of raw milk in accordance with Subchapter F (relating to raw milk for human consumption). Additional permits or licenses may be required for milk haulers and weighers/samplers under regulations established and enforced by the Milk Marketing Board under Part VI (relating to Milk Marketing Board).
(b) Exceptions. The permit requirement of subsection (a) does not apply to the following:
(1) A person selling or delivering milk directly from a dairy farm to a milk plant.
(2) A dairy farm producing and selling milk for pasteurization or milk for manufacturing.
(3) A person selling milk, milk products or manufactured dairy products from a store, when the milk or milk products have been purchased from a person already in possession of a permit to sell milk or milk products.
(4) A hotel, restaurant, soda fountain, boarding house or other place where milk, milk products or manufactured dairy products are to be consumed on-premises, and have been purchased from a person already in possession of a permit to sell milk or milk products.
(5) A person producing and selling milk from a single cow, and exempted from the permit requirement in accordance with the act.
(c) Obtaining a permit. A person seeking a permit may obtain a permit application and additional information by contacting the Department as described in § 59a.3 (relating to contacting the Department). An entity that meets the requirements of § 59a.25 (relating to milk, milk products and manufactured dairy products from points outside this Commonwealth) will be issued a permit.
(d) Requirements for initial issuance of permit. Within 30 days of receiving a complete application for an initial permit, the Department will inspect the applicant's operation to determine whether it is in compliance with the standards of the act and this chapter that would be applicable if the applicant received the permit applied for. These standards shall be met for the Department to issue the permit.
(e) Requirements for issuance of a successor permit. If an applicant seeks a permit that is to take effect upon the expiration of a predecessor permit, the Department will approve the permit application if the dairy operation and the milk, milk products or manufactured dairy products produced from that dairy operation meet the requirements of the act and this chapter.
(f) Duration of permit. A permit will be valid for no more than 1 year. Each permit will expire as of September 1 each year, unless revoked or suspended earlier by the Department.
(g) Ownership of milk permit. A permit is and remains the property of the Department—even when it is in the physical custody of the permitholder. If a milk permit is suspended or revoked, the person in possession of the milk permit shall immediately return or surrender that permit to the Department. In the case of a permit suspension, the Department will promptly return the permit to the permitholder at the end of the suspension period.
(h) Refusal, revocation or suspension of a permit.
(1) Authority. The Department may refuse, revoke or suspend a permit issued under the act or this section upon a finding that the applicant or permitholder has violated the act or this chapter.
(2) Notice and opportunity for a hearing. The Department will notify an applicant or permitholder of a proposed refusal, revocation or suspension of a permit by written notification, and will deliver it by personal service or certified mail. The notice will afford the recipient at least 5 days within which to request an administrative hearing on the proposed action. If no hearing is requested, the Department may enter its final order refusing, suspending or revoking the permit. If a hearing is requested, the Department will conduct the hearing within 30 days of receipt of the request.
(i) Reinstatement of a suspended permit. A person whose permit has been suspended by the Department may make written application to the Department for reinstatement of the permit. The permitholder shall coordinate with the Department to address and resolve the basis for the suspension.
(j) Reference to applicable provisions of the Grade ''A'' PMO. The provisions of the Grade ''A'' PMO, in particular section 3, regarding permits, apply to this section to the extent described in § 59a.11 (relating to adoption of Grade ''A'' PMO).
§ 59a.13. Adulterated or misbranded milk, milk products or manufactured dairy products.
(a) Sales of adulterated or misbranded milk prohibited. A person may not sell adulterated or misbranded milk, milk products or manufactured dairy products.
(b) Seizure, condemnation, denaturing or destruction of milk, milk products or manufactured dairy products. Adulterated or misbranded milk may be seized, condemned, denatured and destroyed by the Department if the Secretary considers the substance unsafe or a menace to public health.
(c) Reference to applicable provisions of the Grade ''A'' PMO. The provisions of the Grade ''A'' PMO, in particular section 2, regarding adulterated or misbranded milk or milk products, apply to this section to the extent described in § 59a.11 (relating to adoption of Grade ''A'' PMO).
§ 59a.14. Labeling: Bottles, containers and packages of milk, milk products or manufactured dairy products.
(a) Department approval required. A permitholder shall, before using a milk, milk product or manufactured dairy product label in commerce, apply for and obtain the approval of the Department for the use of that label. Labels in commercial use as of May 21, 2011, shall have until November 21, 2011, to come into compliance with this registration requirement.
(b) Approval process.
(1) A permitholder seeking the Department's approval of a milk, milk product or manufactured dairy product label shall apply to the Department at the address provided in § 59a.3 (relating to contacting the Department). The applicant may use an application form that the Department will provide upon request, or may apply by letter requesting label approval. The application must include clear, accurate copies of all labels for which approval is sought.
(2) The Department will approve the use of a milk, milk product or manufactured dairy product label if it meets the requirements of the act and this chapter, including the specific requirements of this section.
(3) The Department will, within 10 business days of receiving a complete application, mail the applicant its written approval or denial of the application.
(i) If the application is denied, the written denial will set forth the basis for denial, and afford the applicant notice and opportunity for an administrative hearing on the denial.
(ii) If the application is granted, the written approval will contain a copy of the label and assign a unique serial number to each label approved under the application. The Department will retain copies of these approvals.
(c) Changes of approved labels. If a label is approved under this section, colors and graphics may be changed without requiring reapproval of the label. If the text, type size or wording is to be changed, the label shall be submitted to the Department for approval in accordance with subsection (b).
(d) Label requirements. Bottles, containers and packages enclosing milk, milk products or manufactured dairy products offered for sale shall be labeled. The label shall be approved by the Department in accordance with this section, and contain the following information:
(1) The name of the food.
(2) The net contents.
(3) The common name of the hooved mammal producing the milk preceding the name of the milk or milk product, if the milk or milk product is or is made from milk other than cow's milk.
(4) The words ''keep refrigerated after opening,'' if the milk or milk product is aseptically processed.
(5) The words ''keep refrigerated,'' if the milk or PMO- defined milk product is conventionally pasteurized or UHT pasteurized.
(6) The words ''Grade 'A' '' on the exterior surface, except for bottles, containers and packages of milk and milk products that are not eligible for certification as Grade ''A'' or that are eligible for certification but are not currently certified. Type size may not be larger than letters in basic product name.
(7) The identity of the milk plant where pasteurized, ultrapasteurized, aseptically processed, condensed or dried. When the name and address of a distributor appears in lieu of that of the processor, words such as ''Mfg. for,'' ''Dist. by'' or ''Packed for'' must also appear on the label. Milk or milk products showing a general address or the name and address of a distributor shall be further labeled to identify the processing plant by assigned numerical code or the plant name and address.
(8) The identity of the plant where processed.
(9) The word ''reconstituted'' or ''recombined,'' immediately preceding or immediately following the name of the product, in type at least half the size of name of the product which has been reconstituted, if the milk product is made by reconstitution or recombination.
(10) The volume or proportion of water to be added for reconstitution or recombination, if the milk or milk product is concentrated milk or milk product.
(11) In descending order of predominance, a listing of additives, such as flavors, sweeteners, milk solids, lactose, stabilizers, emulsifiers, vitamins and minerals if used.
(12) The quantity or percentage of United States Recommended Daily Allowance (U.S. RDA) per serving, if vitamins, minerals or milk solids have been added to the milk or milk product.
(13) The word ''pasteurized,'' in type at least one-fourth the height of the letters in the basic product name, if the milk or milk product has been pasteurized. If desired, letters used in modifying terms and ''pasteurized'' may be the same size, but never larger than the product name. Printing must be readily legible.
(14) The word ''homogenized,'' if the milk or milk product has been homogenized.
(15) The words ''protein fortified'' immediately preceding or immediately following the name of the product which has been fortified, in type at least half the size of name of the product which has been fortified, if the milk or milk product is a protein fortified dairy product. The label must include the percentage of milk solids not fat added or the percentage of U.S. RDA of protein, vitamins and minerals per serving on the information panel of the container.
(16) The words ''artificially colored,'' if an artificial color is used for a flavored milk other than chocolate.
(17) The words ''artificially (name of flavor imitated) flavored milk'' in type at least half the size of the name of the product imitated, if an artificial flavor is used for artificially flavored milk.
(18) If the milk or milk product has been cultured or acidulated after pasteurization it may, at the applicant's option, be labeled ''made from pasteurized dairy products.''
(19) If a milk product contains an ''artificial dairy product'' as defined in § 57.1 (relating to definitions) as an ingredient which replaces portions of basic compositional ingredients in the milk product, the phrase ''contains artificial ______ ,'' with the blank filled in with names of the basic compositional ingredients being simulated, immediately following the name of the food.
(20) Any sell-by date information required under § 59a.15 (relating to labeling: milk dating).
(e) Exception. The label requirements prescribed under this section do not apply to milk tank trucks and storage tanks, which are addressed in § 59a.16 (relating to markings, sealing and documentation for vehicles containing milk and milk products), or to raw milk for human consumption, which is addressed in § 59a.411 (relating to label content review by the Department). In addition, these requirements do not apply to cans of raw milk from individual dairy farms, which must be identified by name or number of the producer.
(f) False or misleading material. False or misleading marks, words or endorsements upon the label are prohibited. In determining whether labeling is false or misleading, the Department will take into account not only the specific representations made on the label but also the extent to which the labeling fails to reveal facts that are material in light of such representations. The Department may issue guidance documents addressing false or misleading label statements or any other aspect of labeling under this section. Registered trade designs or terms may be permitted on the container cap or label provided they are not misleading and do not obscure the required labeling.
(g) Reference to applicable provisions of the Grade ''A'' PMO. The provisions of the Grade ''A'' PMO, in particular section 4, regarding labeling, apply to this section to the extent described in § 59a.11 (relating to adoption of Grade ''A'' PMO).
§ 59a.15. Labeling: Milk dating.
(a) Label requirement. The cap or nonglass container of pasteurized milk held in retail food stores, restaurants, schools or similar food facilities for resale shall be conspicuously and legibly marked in a contrasting color with the designation of the ''sell-by'' date—the month and day of the month after which the product may not be sold or offered for sale. The designation may be numerical—such as ''8-15''—or with the use of an abbreviation for the month, such as ''AUG 15 or AU 15.'' The words ''Sell by'' or ''Not to be sold after'' must precede the designation of the date, or the statement ''Not to be sold after the date stamped above'' must appear legibly on the container. This designation of the date may not exceed 17 days beginning after midnight on the day on which the milk was pasteurized.
(b) Prominence of sell-by date on label. The sell-by date shall be separate and distinct from any other number, letter or intervening material on the cap or nonglass container.
(c) Prohibition. Pasteurized milk may not be sold or offered for sale if the milk is sold or offered for sale after the sell-by date designated on the container.
(d) Exemption. The following pasteurized dairy products are exempt from the requirements of this section, provided that the cap or container of all pasteurized dairy products contains, a lot number or manufacturing date code that is acceptable to the Department and can be used for product traceability in the marketplace.
(1) Ultrapasteurized dairy products.
(2) Cultured dairy products.
(3) Aseptically processed dairy products.
(4) Dairy products that have undergone higher heat shorter time pasteurization.
(5) Milk sold or offered for retail sale on the same premises at which it was processed.
(e) Monitoring by the Department.
(1) The Department will periodically sample containers of pasteurized milk in the possession of the processor or distributor. This sampling may occur at any time before the pasteurized milk is delivered to the store or the customer. The Department will sample at least one milk product from each processor each calendar year.
(2) The samples described in paragraph (1) will be analyzed by the Department or a Pennsylvania-approved dairy laboratory, applying a methodology in the most current edition of Dairy Practices Council Guideline No. 10, entitled ''Guidelines for Maintaining and Testing Fluid Milk Shelf Life,'' to determine whether the bacterial test results exceed the bacterial limits for pasteurized milk described in § 59a.21 (relating to standards) prior to the expiration of the sell-by date designated on the retail container.
(3) When two or more samples demonstrate a processor cannot produce pasteurized milk that remains consistently within the bacterial limits referenced in paragraph (2) during a 17-day sell-by period, the Department will require a processor to use a sell-by date of something less than the 17-day period described in subsection (a). The Department will calculate this revised sell-by date so that bacterial growth in the milk will not exceed the referenced bacterial limits within that sell-by period if the milk is maintained in accordance with the temperature standards for pasteurized milk in § 59a.21.
(4) A processor may submit samples to the Department for analysis to obtain approval to resume a 17-day sell-by period for the product sampled. The Department will approve resumption of a 17-day sell-by period when analysis of a sample demonstrates that bacterial growth in the milk will not exceed the referenced bacterial limits within that sell-by period if the milk is maintained in accordance with the temperature standards for pasteurized milk in § 59a.21.
§ 59a.16. Markings, sealing and documentation for vehicles containing milk and milk products.
(a) Marking requirements. A vehicle or milk tank truck containing milk or milk products shall be legibly marked with the name and address of the milk plant or hauler in possession of the contents.
(b) Seal requirement. A vehicle or milk tank truck transporting raw, heat-treated or pasteurized milk and milk products to a milk plant from another milk plant, receiving station or transfer station shall be marked with the name and address of the milk plant from which the milk or milk products are transported, and shall be sealed.
(c) Documentation requirements. A vehicle or milk tank truck transporting raw, heat-treated or pasteurized milk or milk products to a milk plant from another milk plant, receiving station or transfer station shall be accompanied by a legible shipping statement containing the following information:
(1) Shipper's name, address and permit number. A milk tank truck containing milk must include on the weigh ticket or manifest the IMS Bulk Tank Unit (BTU) identification numbers or—for farm groups listed with a milk plant—the IMS Listed Milk Plant Number.
(2) Permit identification of the hauler, if not an employee of the shipper.
(3) Point of origin of shipment.
(4) Tanker identification number.
(5) Name of product.
(6) Weight of product.
(7) Temperature of product when loaded.
(8) Date of shipment.
(9) Name of supervisory regulatory agency at point of origin of shipment.
(10) Whether the contents are raw, pasteurized or in the case of cream, lowfat milk or skim milk—whether it has been heat—treated.
(11) Seal number on inlet, outlet, wash connections and vents.
(12) Grade of product.
(d) Cans of raw milk. All cans of raw milk from individual dairy farms shall be identified by the name or permit number of the individual milk producer.
(e) Additional documentation. Milk transport tank trucks transporting bulk milk and dairy products must be accompanied by documentation, such as a weigh ticket or manifest, which includes the NCIMS BTU Identification Number or the NCIMS Listed Milk Plant Number, for farm groups listed with a milk plant.
(f) Reference to applicable provisions of the Grade ''A'' PMO. The provisions of the Grade ''A'' PMO, in particular section 4, regarding labeling, apply to this section to the extent described in § 59a.11 (relating to adoption of Grade ''A'' PMO).
§ 59a.17. Inspection of dairy farms and milk plants.
(a) General inspection requirement. Dairy farms shall be inspected by an approved inspector at intervals of no greater than 6 months, unless the dairy farm produces raw milk for human consumption under a raw milk permit, in which case the inspection shall be as prescribed in Subchapter F (relating to raw milk for human consumption). Grade ''A'' dairy farms shall be inspected by a certified industry inspector. Milk plants shall be inspected by an approved inspector at intervals of no greater than 3 months, or as otherwise prescribed by the Grade ''A'' PMO, as referenced in subsection (d).
(b) Inspection frequency. Each producer of milk for pasteurization will 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. Producers shall be inspected at least once in each 6-month period by an approved inspector, and an accurate record of farm inspections and quality control testing shall be maintained on forms acceptable to the Department. The records of farm inspections must include the date of inspection, any noted deficiencies, whether the inspection resulted in a passing score, suspension or reinspection. The records of quality control testing must include bacterial count, somatic cell count, drug residue screening results, temperature results, records of water supply testing, copies of warning letters and suspension letters and information required under Appendix N of the Grade ''A'' PMO regarding drug residue testing and farm surveillance.
(c) Notification of producer status. A permitholder shall, within 24 hours of its initial instatement of a producer, its suspension of a producer or its reinstatement of a producer, provide the Department the name and address of the producer and the specific action taken by the permitholder.
(d) Reference to applicable provisions of the Grade ''A'' PMO. The provisions of the Grade ''A'' PMO, in particular section 5, regarding inspection of dairy farms and milk plants, apply to this section to the extent described in § 59a.11 (relating to adoption of Grade ''A'' PMO).
§ 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, an out-of-State dairy laboratory that is listed with the NCIMS or that operates in accordance with the current Evaluation of Milk Laboratories, Recommendations of the United States Public Health Service/Food and Drug Administration and current FDA 2400 Laboratory Series forms, 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 bulk shipments of Grade ''A'' milk, shall obtain a representative sample of commingled milk for pasteurization each processing day. The sample shall be collected by a certified industry plant sampler and analyzed for Beta lactam drug residues in a laboratory as described in subsection (a). If a milk plant is not certified under the NCIMS Interstate Milk Shippers Program, does not receive bulk shipments of Grade ''A'' milk and produces that milk in accordance with a written quality control program addressing the use of animal drugs at that dairy operation, that milk plant may request a variance from the testing requirements in this subsection. 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 in this subsection. A variance issued under this subsection 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 onsite inspections the Department deems necessary to determine whether a successor variance should be issued.
(d) Drug residue testing. Drug residue screening test records shall be maintained on file by the permitholder for at least 2 years.
(e) Reference to applicable provisions of the Grade ''A'' PMO. The provisions of the Grade ''A'' PMO, in particular section 6 and Appendix N, regarding examination of milk and milk products and drug residue testing and farm surveillance, apply to this section to the extent described in § 59a.11 (relating to adoption of Grade ''A'' PMO).
(f) Interpretation of Grade ''A'' PMO. When milk is excluded from market under a provision of the Grade ''A'' PMO on the basis of an accumulation of violative test results and the accelerated sampling testing called for under the Grade ''A'' PMO results in the provisional or final return of milk to market, the Department will consider tests preceding the date of return to market in determining future accumulations of violative test results.
§ 59a.19. Standards for Grade ''A'' 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, in particular the Standards for Grade ''A'' Raw Milk for Pasteurization, Ultrapasteurization or Aseptic Processing set forth in that document and section 7, 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 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) 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.
(b) Reference to applicable provisions of the Grade ''A'' PMO. The provisions of the Grade ''A'' PMO, in particular the Standards for Grade ''A'' Pasteurized, Ultrapasteurized and Aseptically Processed Milk and Milk Products and section 7, 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
§ 59a.21. Standards.
(a) Standards for milk and milk products. The standards that apply to milk and 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.
(5) Drugs. On test of milk ingredients, no positive results on drug residue detection methods as referenced in section 7 of the Grade ''A'' PMO, Table 1, regarding chemical, physical, bacteriological and temperature standards.
(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, in particular section 8, 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, in particular section 9, 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, in particular section 10, 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, in particular section 11, 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, in particular section 12, 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.
The provisions of the Grade ''A'' PMO, in particular section 13, regarding personnel health, are adopted as the regulatory standards of the Department 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, in particular section 16, 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-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. § 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.
§ 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.
§ 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.
§ 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 Pennsyl- vania-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.
§ 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.
§ 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.
§ 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.
§ 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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