TERMS AND APPLICATION


§ 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):

 TemperatureTime  
*145°F(63°C)30 minutes
*161°F(72°C)15 seconds
 191°F(89°C)1 second
 194°F(90°C)0.5 second
 201°F(94°C)0.1 second
 204°F(96°C)0.05 second
212°F(100°C)0.01 second

    *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:

 TemperatureTime  
155°F(69°C)30 minutes
175°F(80°C)25 seconds
180°F(83°C)15 seconds

   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.

Authority

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

Source

   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).

Cross References

   This section cited in 7 Pa. Code §  59.216b (relating to high temperature short-time (HTST) continuous flow pasteurization requirements); and 7 Pa. Code §  59.709 (relating to pasteurized, ultra-pasteurized or aseptically processed and packaged products).



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