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TITLE 25HEALTH SERVICES
PART 1DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 217MILK AND DAIRY
SUBCHAPTER AGRADE SPECIFICATIONS AND REQUIREMENTS FOR MILK
RULE §217.1Definitions

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

  (1) Abnormalities of milk--The following types of lacteal secretions are not suitable for sale:

    (A) abnormal milk that is visibly changed in color, odor, or texture; or

    (B) undesirable milk expected to be unsuitable for consumption, such as milk containing colostrum or blood; or

    (C) contaminated milk unfit for human consumption due to treatment of the animal with any products not labeled for lactating dairy animals, antibiotics which have not met the withhold requirements, or treatment with medicines or insecticides not approved for use on dairy animals by the United States Food and Drug Administration (FDA) or the Environmental Protection Agency.

  (2) Acidified milk--The food produced by souring cream, milk, partially skimmed milk, or skim milk or any combination, with acetic acid, adipic acid, citric acid, fumaric acid, glucono-delta-lactone, hydrochloric acid, lactic acid, malic acid, phosphoric acid, succinic acid, or tartaric acid, with or without the addition of characterizing microbial organisms. Acidified milk is further defined in Title 21, Code of Federal Regulations (CFR), §131.111.

  (3) Acidified sour cream--The product resulting from the souring of pasteurized cream with safe and suitable acidifiers, with or without addition of lactic acid producing bacteria, and as further defined in Title 21, CFR, §131.162.

  (4) Adulterated milk and milk products--Any milk or milk product shall be deemed to be adulterated if:

    (A) it bears or contains any poisonous or deleterious substance in a quantity which may render it injurious to health;

    (B) it bears or contains any added poisonous or deleterious substance for which no safe tolerance has been established by State or Federal regulation, or in excess of such tolerance if one has been established;

    (C) it consists, in whole or in part, of any substance unfit for human consumption;

    (D) it has been produced, prepared, packed, or held under unsanitary conditions;

    (E) its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health;

    (F) any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight or reduce its quality or strength or make it appear better or of greater value than it is;

    (G) any milk or milk product shall be deemed to be adulterated if one or more of the conditions described in the Federal Food, Drug and Cosmetic Act, §402, as amended (21 U.S.C. §342) exist; or

    (H) it is deemed by the department to be abnormal milk.

  (5) Approved Source--A supply of food or products that complies with applicable state and federal laws and is licensed, if required, and inspected by the regulatory authority having jurisdiction over the processing and distribution of food or products.

  (6) Aseptic processing--The term "aseptic processing," when used to describe a milk product, means that the product has been subjected to sufficient heat processing, and packaged in a hermetically sealed container, to conform to the applicable requirements of Title 21, CFR, Part 113 and maintain the commercial sterility of the product under normal non-refrigerated conditions.

  (7) Aseptically processed milk and milk products--Products hermetically sealed in a container and so thermally processed in conformance with Title 21, CFR, Part 113 and the provisions of the "Grade A Pasteurized Milk Ordinance" which is adopted by reference in §217.2 of this title (relating to Adopted Regulations and Standards), so as to render the product free of microorganisms capable of reproducing in the product under normal non-refrigeration conditions of storage and distribution. The product shall be free of viable microorganisms (including spores) of public health significance.

  (8) Automatic milking installation (AMI)--The entire installation of one or more milking units, including the hardware and software utilized in the operation of individual automatic milking units, the animal selection system, the automatic milking machine, the milk cooling system, the system for cleaning and sanitizing the automatic milking unit, the teat cleaning system, and the alarm systems associated with the process of milking, cooling, cleaning, and sanitization.

  (9) Batch number--A designation that is printed on the label of the milk product that allows the history of its production and packaging to be traced.

  (10) Bulk milk hauler/sampler--A bulk milk hauler/sampler is any person who collects official samples and may transport raw milk from a farm and/or raw milk products to or from a milk plant, receiving station, transfer station, frozen dessert manufacturer, or non-grade A dairy product manufacturer, and has in his or her possession a certification from the department.

  (11) Bulk milk pickup 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 from a dairy farm to a milk plant, receiving station, or transfer station.

  (12) Certified milk sampler--Any industry personnel, other than the milk hauler or dairy plant sampler who collects milk or stores an official milk sample.

  (13) C-I-P or cleaned-in-place--The procedure by which sanitary pipelines or pieces of equipment are mechanically cleaned-in-place by circulation.

  (14) Concentrated (condensed) milk--A fluid product, unsterilized and unsweetened, resulting from the removal of a considerable portion of the water from the milk, which, when combined with potable water in accordance with instructions printed on the container, results in a product conforming to the milkfat and milk solids not fat levels of milk as defined in this section.

  (15) Concentrated (condensed) milk products--Homogenized concentrated (condensed) milk, concentrated (condensed) skim milk, concentrated (condensed) low fat milk, and similar concentrated (condensed) products made from concentrated (condensed) milk or concentrated (condensed) skim milk, and which, when combined with potable water in accordance with instructions printed on the container, conform to the definitions of the corresponding milk products in this section.

  (16) Cream--The liquid milk product, high in milkfat, separated from milk, which may have been adjusted by adding thereto: milk, concentrated (condensed) milk, dry whole milk, skim milk, concentrated skim milk, or nonfat dry milk, and contains not less than 18% milkfat.

  (17) Cultured milk--The food produced by culturing cream, milk, partially skimmed milk, or skim milk, used alone or in combination with characterizing microbial organisms. Cultured milk is further defined in Title 21, CFR, §131.112.

  (18) Dairy farm--Any place or premises where one or more cows or goats are kept, and from which a part or all of the milk or milk products is provided, sold, or offered for sale to a milk plant or transfer station.

  (19) Dairy plant sampler--A department employee responsible for the collection of official samples for regulatory purposes.

  (20) Dairy product--Butter, cheese, dry cream, plastic cream, dry whole milk, nonfat dry milk, dry buttermilk, dry whey, whey protein concentrates, evaporated milk (whole or skim), condensed whole milk and condensed skim milk (plain or sweetened), and such other products derived from milk, as may be specified under the statutory standard for butter (Title 21, U.S.C. Part 321a), and the Federal Standards of Identity for Cheese and Related Cheese Products (Title 21, CFR, Part 133).

  (21) Department--The Department of State Health Services, the Commissioner of Health, or an authorized representative of the Commissioner.

  (22) Distributor--Any person who offers for sale or sells to another person any pasteurized milk, pasteurized milk products, dairy product, or frozen dessert product.

  (23) Drug--The term "drug" includes:

    (A) articles recognized in the official United States Pharmacopeia, official Homeopathic Pharmacopeia of the United States or official National Formulary, or any supplement to any of them;

    (B) articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals;

    (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and

    (D) articles intended for use as a component of any articles specified in subparagraphs (A), (B) or (C) of this paragraph, but does not include devices or their components, parts or accessories.

  (24) Eggnog--The food containing cream, milk, partially skimmed milk, or skim milk, used alone or in combination, liquid egg yolk, frozen egg yolk, dried egg yolk, liquid whole eggs, frozen whole eggs, dried whole eggs, or any one or more of the foregoing egg yolk containing products with liquid egg white or frozen egg white, and a nutritive carbohydrate sweetener. Eggnog is further defined in Title 21, CFR, §131.170.

  (25) Federal Food, Drug, and Cosmetic Act--The United States laws pertaining to food, drugs, and cosmetics as specified in 21 U.S.C. §301, et seq.

  (26) Food allergen--A major food allergen is:

    (A) milk, egg, fish (e.g., bass, flounder, or cod), Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans; or

    (B) a food ingredient that contains protein derived from a food specified in subparagraph (A) of this paragraph, except the following:

      (i) any highly refined oil derived from a food specified in subparagraph (A) of this paragraph, and any ingredient derived from such highly refined oil; or

      (ii) a food ingredient that is exempt under U.S.C. Title 21 Chapter 9, Subchapter IV, §343(w)(6) and (7).

  (27) Food allergen cross-contact--The unintentional incorporation of a food allergen into a food.

  (28) Freezer--A piece of equipment which converts mix and/or other ingredients to a hardened or semi-hardened state using the technique of freezing during processing or manufacturing of those products commonly known as ice cream, ice cream mix, frozen dessert, frozen dessert mix, and nondairy frozen dessert mix.

  (29) Frozen dessert--Any of the following: ice cream, light ice cream, ice milk, frozen custard, fruit sherbet, non-fruit water ice, frozen dietary dairy dessert, frozen yogurt, quiescently frozen confection, quiescently frozen dairy confection, mellorine, lorine, parevine, freezer-made milk shake, or nondairy frozen dessert. The term also includes mix used in the freezing of one of those frozen desserts.

  (30) Frozen dessert manufacturer or plant--A person who manufactures, processes, converts, partially freezes or freezes any mix, be it dairy, nondairy frozen desserts for distribution or sale at wholesale. This definition shall not include a frozen dessert retail establishment.

  (31) Frozen dietary dairy dessert and frozen dietary dessert--A food for any special dietary use, prepared by freezing, with or without agitation, composed of a pasteurized mix which may contain fat, protein, carbohydrates, flavoring, stabilizers, emulsifiers, vitamins, and minerals.

  (32) Frozen low fat yogurt and mix (also called low fat frozen yogurt)--Complies with the provisions of frozen yogurt, except that:

    (A) the milk fat content of the finished food is not less than 0.5%, but not more than 2.0%; and

    (B) the name of the food is "frozen low fat yogurt."

  (33) Frozen low fat yogurt dry mix--The unfrozen dry powdered combination of ingredients which, when combined with potable water and when frozen while stirring, will produce a product conforming to the definition of frozen low fat yogurt.

  (34) Frozen milk concentrate--A frozen milk product with a composition of milkfat and milk solids not fat in such proportions 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.

  (35) Frozen skim milk yogurt--Complies with the provision of frozen yogurt, except that:

    (A) the milkfat content of the finished food is less than 0.5%; and

    (B) the name of the food is either "frozen skim milk yogurt" or "frozen nonfat yogurt."

  (36) Frozen yogurt--

    (A) Frozen yogurt is the food which is prepared by freezing, while stirring, a mix composed of one or more of the optional dairy ingredients provided for in ice cream and frozen custard, and which may contain other safe and suitable ingredients.

    (B) The dairy ingredient(s), with or without other ingredients, is/are pasteurized and subsequently cultured with bacterial cultures acceptable to the state health authority.

Cont'd...

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