Subchapter A. PRELIMINARY PROVISIONS

§ 59.1. Definitions.

 The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:

   Abnormal milk—Milk secreted from cows immediately after parturition, curdled, ropy, bloody or mastitic condition or cows treated with, or cows which have consumed chemical, medicinal or radioactive agents which are capable of being secreted in the milk and which, in the judgment of the Department may be deleterious to human health.

   Acceptable milk—Milk that qualified under §  59.502 (relating to sight and odor) as to sight and odor, and that is classified No. 1 or No. 2 for sediment content—§  59.503 (relating to sediment content classification)—and No. 1 or No. 2 for bacterial estimate—§  59.504 (relating to bacterial estimate classification).

   Approved dairy ingredients—Milk and dairy products approved by the Department.

   Approved milkgrader—A person approved by the Department for the grading of raw milk for manufacturing in accordance with the quality standards and procedures of this subchapter using sight, odor and sediment grading.

   Approved sampler—A person certified by the Department to obtain samples of milk or milk products for analysis by a Pennsylvania approved laboratory.

   Aseptically processed dairy products—Milk and milk products which are packaged in hermetically sealed containers allowing storage for long periods of time without refrigeration.

   Aseptically processed and packaged milk or milk product—Milk or milk product thermally processed, either before or after sealing in a hermetically sealed container, so as to render the product free of microorganisms capable of reproducing in the product under normal nonrefrigerated conditions of storage and distribution, and shall be free of viable microorganisms (including spores) of public health significance. The product shall conform with applicable provisions of the 1978 Grade A Pasteurized Milk Ordinance.

   Bulk milk pick-up tanker—A vehicle—including the truck, tank, and those appurtenances necessary for its use—used by a milk hauler to transport bulk raw milk for pasteurization or for manufacturing purposes from a dairy farm to a transfer station, receiving station, or milk plant.

   Bulk tank unit (BTU)—A specified group of dairy farms from which milk for pasteurization or for manufacturing purposes is collected by a milk tank truck.

   Certified milk—Milk from dairy farms operated in accordance with ‘‘Methods and Standards for the Production and Distribution of Certified Milk,’’ last adopted by the American Association of Medical Milk Commissioners, Inc., the production and handling of which shall be certified by a commission instituted in compliance herewith.

   Classification of farm sanitation compliance—

   (i) Passing—A general compliance with sanitary standards established for the production of milk.

   (ii) Reinspect—A significant noncompliance with sanitary standards established for the production of milk requiring remedial action and a subsequent review to determine conformity.

   (iii) Suspend—Major noncompliance with sanitary standards or evidence of conditions that would render the milk unsafe for human consumption, or if on the reinspection it is found that sufficient progress has not been made on the previously recommended corrections.

   Cleaned-In-Place (CIP)—The procedure by which sanitary pipelines or pieces of dairy equipment are mechanically cleaned in place by circulation.

   Commingled milk—Milk from two or more producers; in a milk plant, a representative sample of all daily sources of milk prior to pasteurization.

   Cowyard—The enclosed or unenclosed area adjacent to the milking barn in which cows may congregate.

   Dairy farm—Any place where cows or goats are kept and from which a part or all of the milk is sold.

   Department—The Pennsylvania Department of Agriculture.

   Designated inspector—A Pennsylvania Approved Inspector who has been certified to inspect dairy farms on which milk is produced for an interstate milk shipper.

   Dry milk and whey products—Products which have been produced for use in pasteurized milk or milk products and which have been manufactured under this chapter.

   Excluded milk for manufacturing—All of a producer’s milk excluded from the market by §  59.507 (relating to inspection and testing of milk).

   Food establishment—A retail food store and a room, building or place or portion thereof or vehicle maintained, used or operated for the purpose of commercially storing, packaging, making, cooking, mixing, processing, bottling, baking, canning, freezing, packing or otherwise preparing or transporting or handling food. The term includes those portions of public eating and drinking licensees which offer food for sale for off-premises consumption, except those portions of establishments operating exclusively under milk or milk products permits.

   Growth inhibitor—Any antimicrobial adulterant, including but not limited to antibiotics.

   Hermetically sealed container—A container that is designed and intended to secure against entry of microorganisms and thereby maintain the commercial sterility of its contents after processing.

   Higher heat shorter time pasteurization—A process through which every particle of a dairy product is heated to between 191°F and 212°F at holding times between 1.0 and 0.1 seconds before packaging, so as to produce a product which has an extended shelf life under refrigerated conditions.

   Homogenized—Milk or a milk product has been treated to insure breakup of the fat globules to such an extent that, after 48 hours of quiescent storage at 45 F(7°C), no visible cream separation occurs on the milk and that the fat percentage of the top 100 milliliters of milk in a quart, or of proportionate volumes in containers of other sizes, does not differ by more than 10% from the fat percentage of the remaining milk as determined after thorough mixing.

   Lactose-reduced milk or lactose-reduced lowfat milk or lactose-reduced skim milk—The product resulting from the treatment of milk, lowfat milk or skim milk by the addition of safe and suitable enzymes to convert sufficient amounts of lactose to glucose or galactose, or both, so that the remaining lactose is less than 30% of the lactose in milk, lowfat milk or skim milk.

   Manufactured dairy products—Butter, cheese (natural or processed), dry whole milk, nonfat dry milk, dry buttermilk, dry whey and dry whey products, evaporated milk (whole or skim), condensed whole and condensed skim milk (plain or sweetened), and other products for human consumption designated by the Secretary.

   Milk—The natural lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows or goats.

   Milk distributor—Any person who offers for sale or sells any milk or milk product.

   Milk for manufacturing purposes—Milk produced for processing and manufacturing into products for human consumption, not subject to requirements of milk for pasteurization, except for applicable provisions in this chapter.

   Milk for pasteurization—Milk which conforms with relevant provisions of this chapter and is used in the preparation of pasteurized milk and milk products.

   Milk plant—Any place where milk or milk products are collected, handled, processed, stored, pasteurized, packaged, or prepared for distribution.

   Milk processor—Any person who operates a plant where milk is received or processed.

   Milk producer—Any person who operates a dairy farm.

   Milk products—Ice cream, ice cream mix, custard ice cream, French ice cream, frozen custard, ice milk, sherbet, and other similar frozen and semifrozen products and all dairy products used in the manufacture thereof.

   Milk tank truck—A bulk milk pick-up tanker or a milk transport tank.

   Milk transport tank—A vehicle including the truck and tank used by a milk hauler to transport bulk shipments of milk from a transfer station, receiving station, or milk plant to another transfer station, receiving station, or milk plant.

   Milking parlor—The area of a dairy barn which is used exclusively for the milking of cows and in which no bedding is used.

   New producer—A producer who has not produced milk or cream for pasteurization or for manufacturing purposes.

   Official laboratory—A biological, chemical, or physical laboratory which is under the direct supervision of the Department.

   Pasteurized concentrated dairy products—Includes homogenized concentrated milk, concentrated skim milk, concentrated lowfat milk, and similar concentrated products made from concentrated milk or concentrated skim milk, which, when combined with potable water in accordance with instructions printed on the container, conform with the definitions of the corresponding dairy products in this section.

   Pasteurized frozen milk concentrate—A frozen dairy product with a composition of milkfat and milk solids not fat in proportions so that, when a given volume of concentrate is mixed with a given volume of water, the reconstituted product conforms to the milkfat and milk solids not fat requirements of whole milk. In the manufacturing process, water may be used to adjust the primary concentrate to the final desired concentration. The adjusted primary concentrate is pasteurized, packaged, and immediately frozen. This product is stored, transported and sold in the frozen state.

   Pasteurized low-sodium milk or low-sodium lowfat milk or low-sodium skim milk—The product resulting from the treatment of milk, lowfat milk or skim milk by a process of passing the milk, lowfat milk or skim milk through an ion exchange resin process or by any process which has been recognized by the Food and Drug Administration that effectively reduces the sodium content of the product to less than 10 milligrams in 100 milliliters.

   Pasteurized product—Every particle of such product shall have been heated in properly operated equipment approved by the Secretary, to one of the temperatures specified in the following table and held continuously at or above that temperature for the specified time (or other time/temperature relationship equivalent thereto in microbial destruction):

    *If the fat content of the dairy product is 10% or more, or if it contains added sweeteners, the specified temperature shall be increased by 5°F(3°C); provided that eggnog and frozen dessert mix containing dairy products shall be heated to at least the following temperature and time specifications:

   Nothing in this definition shall be construed as barring any other pasteurization process which has been recognized by the Food and Drug Administration to be equally efficient and which is approved by the Secretary.

   Pennsylvania approved dairy laboratory—

     (i) A commercial or regulatory laboratory authorized by the Department to do official analyses of milk and milk products.

     (ii) A milk industry laboratory officially designated by the Department for the examination of producer samples of raw milk for pasteurization or of commingled raw milk for pasteurization for the detection of growth inhibitor residues and bacterial limits. Such laboratories may also be designated for the examination of milk products—frozen desserts and frozen desserts mixes—processed under their direct control.

   Pennsylvania approved inspector—A person who has demonstrated, by examination and field evaluation, his proficiency in inspecting dairy farms and has been issued a license by the Secretary to enforce this part.

   PMO—The 1978 Grade A Pasteurized Milk Ordinance, which is a document published periodically by the United States Department of Health and Human Services covering the recommendations of the United States Public Health Service/Food and Drug Administration giving procedures governing the Cooperative State—Public Health Service/Food and Drug Administration Program for certification of interstate milk shippers.

   Permit holder—A person holding a permit issued by the Department to sell milk or milk products.

   Probational milk—Milk classified No. 3 for sediment content—§  59.503 or milk classified undergrade for bacterial estimate—§  59.504 that may be accepted by plants for specific time periods.

   Raw milk—Raw milk is milk which conforms with the relevant provisions of this chapter and may be sold to consumers without further treatment or processing.

   Receiving station—Any place where raw milk is received, collected, handled, stored, or cooled and prepared for further transporting.

   Reject milk—Milk that does not qualify under §  59.502 or that is classified No. 4 for sediment content—§  59.503, which is rejected by the plant under §  59.505 (relating to rejected milk).

   Retail food store—An establishment or section of an establishment where food and food products are offered to the consumer and intended for off-premises consumption.

   Sanitization—The application of any effective method or substance to a clean surface for the destruction of pathogens and of other organisms as far as is practicable.

   Secretary—The Secretary of Agriculture of the Commonwealth or his authorized representative.

   3A Sanitary Standards—Standards promulgated jointly by the Sanitary Standards Subcommittee of the Dairy Industry Committee; the Committee on Sanitary Procedure of the International Association of Milk, Food and Environmental Sanitarians, Inc.; and the Milk and Food Branch, Division of Environmental Engineering and Food Protection, Public Health Service, Department of Health and Human Services.

   Standard Methods—Standard Methods for the Examination of Dairy Products, published by the American Public Health Association.

   Transfer producer—A producer who has sold milk or cream, or both, to a milk plant and who changes his sales to another milk plant.

   Transfer station—Any place where milk or milk products are transferred directly from one milk tank truck to another.

   Ultra-pasteurized product—A product thermally processed at or above 280°F (138°C) for at least 2 seconds, either before or after packaging, so as to produce a product which has an extended shelf life under refrigerated conditions.

   Weigher/sampler—A bulk milk pick-up driver or a milk plant person certified by the Department to take samples of producers’ milk for chemical and bacteriological analyses.

   The provisions of this §  59.1 issued under the act of July 2, 1935 (P. L. 558, No. 163) (31 P. S. § §  645—660f).

   The provisions of this §  59.1 amended October 11, 1985, effective October 12, 1985, 15 Pa.B. 3642; amended July 5, 1996, effective July 6, 1996, 26 Pa.B. 3129; amended December 13, 1996, effective December 14, 1996, 26 Pa.B. 5950; amended September 5, 2003, effective September 6, 2003, 33 Pa.B. 4445. Immediately preceding text appears at serial pages (223210) to (223216).

 This chapter will be applied in conjunction with Chapter 57 (relating to milk and dairy products—general provisions) concerning identity of milk and milk products.

SPECIFIC PROVISIONS

§ 59.11. Contents.

 Milk that is in final package form for beverage use shall contain not less than 8.25% milk solids not fat and not less than 3.25% milkfat.

 (a)  Milk or milk products produced and distributed for sale shall not be adulterated in any manner by the addition of substances not normally found therein, except those substances approved by the Secretary in this chapter.

 (b)  The Secretary may seize, condemn, denature, or destroy any milk or milk product without compensation to the owner or owners thereof if he considers the milk or milk product unsafe or a menace to public health.

 (a)  Permits will be required for the sale of milk and milk products and will be issued only upon application.

 (b)  Separate permit shall be obtained for each milk plant, milk distributor, receiving station, transfer station, and bulk tank unit and by every producer of raw milk.

 (c)  The permit year shall begin September 1 of each year and end on August 31 of the following year.

   This section cited in 7 Pa. Code §  59.716 (relating to permits).

LABELING

§ 59.21. General labeling requirements.

 (a)  The term, ‘‘milk,’’ unqualified, means cow’s milk. Milk derived from goats shall be labeled as such.

 (b)  All bottles, containers and packages enclosing milk and milk products shall be labeled in accordance with § §  57.41 and 57.42 (relating to labeling) and, where specific labeling requirements are not prescribed in this section or §  59.22 (relating to milk dating), Federal labeling requirements shall be followed.

 (c)  All bottles, containers, and packages enclosing milk or milk products offered for sale, except milk tank trucks, storage tanks, and cans of raw milk from dairy farms shall be marked with the following information:

   (1)  Name of the food, raw, pasteurized, certified, or other such designations as approved by the Department.

   (2)  Name and address of the processor or distributor, as appropriate.

   (3)  Identity of plant where processed.

   (4)  The word ‘‘reconstituted’’ or ‘‘recombined’’ if the product is made by reconstitution or recombination.

   (5)  The volume or proportion of water to be added for reconstitution or recombination, in the case of concentrated milk or milk products.

 (d)  Proposed labeling of all containers and closures shall be submitted to the Department for approval.

 (e)  All vehicles containing milk or dairy products shall be legibly marked with the name and address of the milk plant or hauler in possession of the contents. Milk transport tank trucks transporting bulk milk and dairy products shall be sealed and shall be accompanied by a legible shipping statement containing the following information:

   (1)  Shipper’s name, address, and plant identification number.

   (2)  Identification of hauler.

   (3)  Point of origin of shipment.

   (4)  Tanker identification number.

   (5)  Name of product.

   (6)  Weight of product.

   (7)  Grade of product.

   (8)  Temperature of product.

   (9)  Date of shipment.

   (10)  Name of supervisory regulatory agency at point of origin.

   (11)  Whether the product is raw, pasteurized or heat-treated.

 (f)  All cans of raw milk from individual dairy farms shall be identified by name or number of the producer.

 (g)  Misleading marks, words or endorsements upon the label are prohibited. 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.

 (a)  Label requirement. The cap or nonglass container of pasteurized milk held in retail food stores, restaurants, schools or similar food establishments 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’’ shall precede the designation of the date, or the statement ‘‘Not to be sold after the date stamped above’’ shall 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 either of the following occurs:

   (1)  The milk is sold or offered for sale after the sell-by date designated on the container.

   (2)  Without regard to the sell-by date designated on the container, the milk exceeds the bacterial limits for pasteurized milk described in §  59.52 (relating to table).

 (d)  Exemption. The following pasteurized dairy products are exempt from the requirements of this section:

   (1)  Ultra-pasteurized 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) shall be analyzed by a Pennsylvania-approved dairy laboratory, applying a methodology set forth 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 §  59.52 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 §  59.52.

   (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 §  59.52.

   The provisions of this §  59.22 amended under the act of July 2, 1935 (P. L. 589, No. 210) (31 P. S. § §  645—660g).

   The provisions of this §  59.22 amended September 4, 1987, effective September 5, 1988, 17 Pa.B. 3599; amended August 9, 1991, effective August 10, 1991, 21 Pa.B. 3508; amended July 5, 1996, effective July 6, 1996, 26 Pa.B. 3129; amended September 5, 2003, effective September 6, 2003, 33 Pa.B. 4445. Immediately preceding text appears at serial pages (217606) to (217607).

   This section cited in 7 Pa. Code §  46.385 (relating to potentially hazardous food: hot and cold holding); 7 Pa. Code §  59.21 (relating to general labeling requirements); and 7 Pa. Code §  59.32 (relating to sampling and examination).

QUALITY CONTROL

§ 59.31. Inspection of dairy farms.

 (a)  Each producer of milk for pasteurization will be inspected initially and on any change of market by a Pennsylvania approved inspector and shall have a passing score before the first milk is shipped. All producers shall be inspected no less than once in each 6-month period by a Pennsylvania approved inspector, and an accurate record of farm inspections shall be maintained on forms acceptable to the Secretary.

 (b)  Producers who cannot produce milk of a wholesome, sanitary quality are to be excluded. Producers who are not in substantial compliance with § §  59.101—59.121 (relating to sanitation requirements applicable to production of milk for pasteurization) will be reinspected after an appropriate time for correction of deficiencies.

 (c)  Inspectors of farms producing milk for interstate shipment will be designated as an agent of the Secretary and certified in accordance with provisions of the PMO.

 (a)  The sampling and testing required in this section shall be the responsibility of the permit holder.

 (b)  Raw milk and raw cream shall be tested at least semimonthly for the standard plate count and coliform group and monthly for somatic cell count and growth inhibitor.

 (c)  It shall be the responsibility of the weigher/sampler to collect a representative sample of milk from each farm bulk tank prior to transferring milk from a farm bulk tank, truck or other container. All samples shall be collected and delivered to a milk plant, receiving station, transfer station, laboratory or other location approved by the Department.

 (d)  At least monthly, one sample of milk for pasteurization shall be obtained from each producer by an approved sampler. At least monthly, one sample of commingled milk shall be taken by an approved sampler from each milk plant after receipt of the milk by the plant and prior to pasteurization. In addition, at least monthly, one sample of pasteurized milk and each milk product shall be taken from each milk plant. Frozen desserts—vanilla, chocolate, and one other flavor where applicable—shall be tested at least monthly for the standard plate count and coliform group. Milk products mix shall be tested at least monthly for the standard plate count, coliform group, and phosphatase activity. Samples of milk and milk products shall be taken while in possession of the processor or distributor at any time prior to delivery to the store or customer. Samples of milk and milk products from dairy retail stores, food service establishments, grocery stores, and other places where milk and milk products are sold shall be examined periodically as determined by the Department; and the results of such examination will be used to determine compliance with §  59.11 (relating to contents), §  59.16 (relating to adulterated milk or milk products), and § §  59.21 and 59.22 (relating to labeling). Proprietors of such establishments shall furnish the Department, upon request, with the names of all distributors from whom milk or milk products are obtained.

 (e)  Required bacterial counts, somatic cell counts, and cooling temperature checks shall be performed on milk for pasteurization. In addition, growth-inhibitor tests on each producer’s milk or on commingled raw milk from tank trucks shall be conducted at least monthly. When commingled milk is tested, all producers shall be represented in the sample. All individual sources of milk shall be tested when test results on the commingled milk are positive. Required bacterial counts, growth-inhibitor tests, coliform determinations, phosphatase tests, and cooling temperature checks shall be performed on pasteurized milk and dairy products.

 (a)  Whenever two of the last four consecutive bacterial counts, somatic cell counts, coliform determinations, or cooling temperatures—taken on separate days—exceed the limit of the standard for the milk or dairy products, the Department will send a written notice thereof to the permit holder concerned. In the case of individual producers, the permit holder shall send the written notice. This notice shall be in effect so long as two of the last four consecutive samples exceed the limit of the standard. In the case of an individual milk producer, whenever test standards are exceeded by three of the last five bacteria, temperature, or somatic cell counts, the plant purchasing the milk shall immediately exclude such milk from the supply for a period of at least two days or until such time as conformance can reasonably be assured. In the case of a permit holder, whenever the standard of the product is exceeded by three of the last five bacteria counts, coliform determinations or temperature determinations, the permit holder shall be subject to the punitive clause of the Milk Sanitation Law, section 20 of the act of July 2, 1935 (P. L. 589, No. 210) (31 P. S. §  660d).

 (b)  Whenever a phosphatase test is positive, the cause shall be determined. When the cause is improper pasteurization, it shall be corrected, and any milk or milk product involved shall not be offered for sale. Reference should be made to §  59.309 (relating to approved laboratory reports).

 (c)  Whenever a growth-inhibitor or pesticide residue test is positive, an investigation shall be made to determine the cause, and the cause shall be corrected. An additional sample shall be taken and tested for growth-inhibitor or pesticide residues, and no milk shall be offered for sale until it is shown by a subsequent sample to be free of growth-inhibitor or pesticide residue or below the actionable levels established for such residues.

 (d)  When a test conducted by an approved laboratory indicates that milk from a producer is unsafe due to a growth inhibitor, the permit holder shall immediately notify and suspend the producer for 2 days. A test shall be made of the subsequent milking after suspension, and it must be free of growth inhibitor before offering that milk for sale.

 (a)  Samples analyzed for added water and found to have a freezing point above -0.525°H(-0.508°C) shall be considered adulterated unless proven free of added water.

 (b)  Samples shall be analyzed at an official or a Pennsylvania approved dairy laboratory. All sampling procedures and required laboratory examinations with the current edition of the Standard Methods for the Examination of Dairy Products of the American Public Health Association and the current edition of the Official Methods of Analysis of the Association of Official Analytical Chemists or other methods approved by the Secretary. Such procedures, including the certification of sample collectors and examination, shall be evaluated in accordance with the Evaluation of Milk Laboratories, 1978 Recommendations of the United States Public Health Service/Food and Drug Administration. Examinations and tests to detect adulterants, including pesticides, shall be conducted as the Department requires.

 (c)  Assays of milk and dairy products to which vitamins or minerals have been added shall be made at least annually in a laboratory acceptable to the Department, and a copy of the results shall be sent to the Department. If, in the opinion of the Department, there is reason to doubt that fortification is being carried out properly, the Department may require additional samples to be tested at the expense of the permit holder.

   This section cited in 7 Pa. Code §  59.302 (relating to raw milk); and 7 Pa. Code §  59.304 (relating to milk and milk products from beyond the limits of routine inspection).