Current through Reg. 49, No. 45; November 8, 2024
Section 217.1 - DefinitionsThe 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 milkfat 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.(C) The titratable acidity of the cultured frozen yogurt is not less than 0.5%, calculated as lactic acid, except if the frozen yogurt is flavored by the addition of a non-fruit characterizing ingredient(s).(D) The milkfat content of frozen yogurt is not less than 3.25% by weight, except that when bulky characterizing ingredients are used the percentage milkfat is not less than 2.5%.(E) The finished frozen yogurt shall weigh not less than five pounds per gallon.(F) The name of the food is "frozen yogurt."(37) Goat milk--The normal lacteal secretion, practically free of colostrum, obtained by the complete milking of one or more healthy goats. Goat milk sold in retail packages shall contain not less than 2.5% milkfat and not less than 7.5% milk solids not fat. The word "milk" includes goat milk.(38) Goat milk ice cream--The food defined in Title 21, CFR, §135.115.(39) Grade A dry milk and whey products--Products which have been produced for use in Grade A pasteurized or aseptically processed milk products and which have been manufactured under the provisions of the most current revision of the "Grade A Pasteurized Milk Ordinance."(40) Grade A Pasteurized Milk Ordinance--The document published by the United States Department of Health and Human Services, Public Health Service/Food and Drug Administration. The document consists of the following parts: The Grade A Pasteurized Milk Ordinance with Administrative Procedures; illustrations, tables, supplements, appendices; and an index. Copies are on file in the Milk Group, Consumer Protection Division, Department of State Health Services, 8407 Wall Street, Austin, Texas, and are available for review during normal business hours. For purposes of this chapter, "U.S. Public Health Services Grade A Pasteurized Milk Ordinance" is an equivalent term.(41) Grade A raw milk and Grade A raw milk products--Milk products that are manufactured in compliance with the provisions of Subchapter B of this chapter (relating to Grade A Raw Milk and Raw Milk Products), and are offered for sale to the public without pasteurization. (A) These products include, but are not limited to plain raw milk, raw flavored milk, raw low-fat milk, raw low-fat flavored milk, raw skim milk, raw skim flavored milk, raw cultured milk, raw cultured low fat milk, raw cultured skim milk, raw cream, raw heavy cream, raw light cream, raw sour cream, raw acidified sour cream, raw cultured sour cream, raw light whipping cream, raw heavy whipping cream, raw whipped cream, raw light whipped cream, raw plain yogurt, raw flavored yogurt, raw low fat yogurt, raw nonfat yogurt, raw drinkable yogurt, raw drinkable probiotic yogurt, raw buttermilk, raw half-and-half, raw sour half-and-half, raw acidified sour half-and-half, raw cultured sour half-and-half, raw eggnog, raw whey, raw flavored whey, raw whey protein, raw flavored whey protein, and raw keifer.(B) Grade A raw milk and raw milk products do not include the following. (i) Infant formula, ice cream or other frozen desserts, butter, or raw cheese that is not aged a minimum of 60 days.(ii) Raw milk or raw milk products that are a blend of raw milk from more than one raw milk processer dairy farm.(42) Grade A raw milk processor--A person who processes milk as defined in paragraph (55) of this section, that is produced in compliance with the provisions of Subchapter B of this chapter and is offered for sale to the public without pasteurization.(43) Grade A raw milk processor dairy farm--Any place or premise where one or more lactating animals (cows, goats, sheep, water buffalo, or other hooved animals) are kept, and from which a part of or all the raw milk and raw milk products are produced, processed, bottled, and offered, sold, or offered for sale to the public.(44) Half-and-half--The food consisting of a mixture of milk and cream which contains not less than 10.5% but less than 18% milkfat. Half-and-half is further defined in Title 21, CFR, §131.180.(45) Heavy cream or heavy whipping cream--Cream which contains not less than 36% milkfat and as further defined in Title 21, CFR, §131.150.(46) Hermetically sealed container--A container that is designed and intended to be secure against the entry of microorganisms and thereby maintain the commercial sterility of its contents after processing.(47) Homogenized--Milk or a milk product has been treated to ensure breakup of the fat globules to such an extent that, after 48 hours of quiescent storage at 4.4 degrees Celsius (40 degrees Fahrenheit), no visible cream separation occurs on the milk; and 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.(48) Ice cream and frozen custard--The foods defined in Title 21, CFR, §135.110.(49) Label--A display of written, printed, or graphic matter upon the immediate container of a product or wrappers accompanying such a container.(50) Light cream--Cream which contains not less than 18% but less than 30% milkfat, and as further defined in Title 21, CFR, §131.155.(51) Light whipping cream--Cream which contains not less than 30% but less than 36% milkfat, and as further defined in Title 21, CFR, §131.157.(52) Lorine--The food prepared from the same ingredients and in the same manner prescribed for mellorine and complies with all the provisions for mellorine except that: (A) its content of fat is at least 2% but less than 6%;(B) its content of milk solids not fat is not less than 10%;(C) caseinates may be added when the content of total milk solids is not less than 10%;(D) the provision for reduction in fat and milk solids not fat from the addition of bulky ingredients in mellorine does not apply;(E) the quantity of food solids per gallon is not less than 1.2 pounds; and(F) the name of the food is "Lorine."(53) Low fat yogurt--The food produced by culturing cream, milk, partially skimmed milk, or skim milk, used alone or in combination with a characterizing bacterial culture that contains the lactic acid-producing bacteria, Lactobacillus bulgaricus and Streptococcus thermophilus. Low fat yogurt is further defined in Title 21, CFR, §131.203.(54) Mellorine--The food defined in Title 21, CFR, §135.130(a) - (d).(55) Milk--The lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows, sheep, goats, water buffaloes or other hooved animals, and as further defined in Title 21, CFR, §131.110.(56) Milk hauler--A person who transports raw milk and raw milk products to or from a milk plant, receiving station, transfer station, frozen dessert manufacturer, or non-grade A dairy product manufacturer.(57) Milk plant--Any place, premises or establishment where milk or milk products are collected, handled, processed, dried, stored, pasteurized, ultra-pasteurized aseptically processed, bottled, or prepared for distribution. This term also means a processing plant, manufacturing plant, or bottling plant in these sections.(58) Milk producer--Any person who operates a producer dairy farm and provides, sells, or offers milk for sale to a milk plant, receiving station, transfer station, frozen dessert manufacturer, or non-grade A dairy product manufacturer.(59) Milk products-- (A) Milk products include cream, light cream, light whipping cream, heavy cream, heavy whipping cream, whipped cream, whipped light cream, sour cream, acidified sour cream, cultured sour cream, half-and-half, sour half-and-half, acidified sour half-and-half, cultured sour half-and-half, reconstituted or recombined milk and milk products, concentrated (condensed) milk, concentrated (condensed) milk products, reduced fat milk, nonfat (skim) milk, low fat milk, frozen milk concentrate, eggnog, buttermilk, cultured milk, cultured low fat milk, cultured nonfat (skim) milk, yogurt, low fat yogurt, nonfat yogurt, acidified milk, acidified low fat milk, acidified nonfat (skim) milk, low-sodium milk, low-sodium low fat milk, low-sodium nonfat (skim) milk, lactose-reduced milk, lactose-reduced low fat milk, lactose-reduced nonfat (skim) milk, aseptically processed and packaged milk and milk products as defined in this section, milk, low fat milk, or nonfat (skim) milk with added safe and suitable microbial organisms, and any other milk product made by the addition or subtraction of milkfat or addition of safe and suitable optional ingredients for protein, vitamin, or mineral fortification of milk products defined herein.(B) Milk products also include those dairy foods made by modifying the federally standardized products listed in this section in accordance with Title 21, CFR, §130.10, Requirements for foods named by use of nutrient content claim and standardized term.(C) This definition shall include those milk and milk products, as defined herein, which have been aseptically processed and then packaged.(D) Milk and milk products which have been retort processed after packaging or which have been concentrated, condensed, or dried are included in this definition only if they are used as an ingredient to produce any milk or milk product defined herein, or if they are labeled as Grade A.(E) This definition is not intended to include dietary products (except as defined herein), infant formula, ice cream or other desserts, butter, or cheese.(60) Milk tank truck--The term used to describe both a bulk milk pickup tanker and a milk transport tank.(61) Milk tank truck cleaning facility--Any place, premise, or establishment, separate from a milk plant, receiving, or transfer station, where a milk tank truck is cleaned and sanitized.(62) Milk tank truck driver--A milk tank truck driver is any person who transports raw or pasteurized milk products to or from a milk plant, receiving station, or transfer station. Any transportation of a direct farm pickup requires the milk tank truck driver to have responsibility for accompanying official samples.(63) Milk transport tank or tanker--A vehicle, including the truck and tank, used by a milk hauler to transport bulk shipments of milk from a milk plant, receiving station, transfer station, frozen dessert manufacturer, or non-grade A dairy product manufacturer to another milk plant, receiving station, transfer station, frozen dessert manufacturer, or non-grade A dairy product manufacturer.(64) Milk transportation company--An entity responsible for ensuring milk tank trucks are in compliance with the provisions of Subchapter D of this chapter (relating to Bulk Milk Regulations).(65) Misbranded milk and milk products--Milk and milk products are misbranded if: (A) their container bears or is accompanied by any false or misleading written, printed, or graphic matter;(B) milk labeling does not conform to the definitions as contained in this chapter;(C) they are not labeled in accordance with § 217.24 of this title (relating to Labeling) for Grade A Raw Milk and Raw Milk Products; § 217.43 of this title (relating to Labeling) for Rules for the Manufacture of Frozen Desserts; and § 217.81 of this title (relating to Labeling) for Dairy Products and Milk for Manufacturing Purposes; or(D) one or more of the conditions described in the Federal Food, Drug and Cosmetic Act, §403, as amended ( 21 U.S.C. § 343 ) exists.(66) Multi-use container--Any container having a product-contact surface and used in the packaging, handling, storing, or serving of milk or milk products, which, if it remains in good repair and is properly washed and sanitized, may be utilized for multiple usage.(67) Nondairy frozen dessert-- (A) Nondairy frozen dessert is the food which is prepared by freezing, while stirring, a nondairy frozen dessert mix composed of one or more of the optional characterizing ingredients specified in subparagraph (B) of this paragraph, sweetened with one or more of the optional sweetening ingredients specified in subparagraph (C) of this paragraph. The nondairy product, with or without water added, may be seasoned with salt. One or more of the ingredients specified in subparagraph (D) of this paragraph may be used. Pasteurization is not required. The optional caseinates specified in subparagraph (D)(i) of this paragraph are deemed not to be dairy products.(B) The optional flavoring ingredients referred to in subparagraph (A) of this paragraph are natural and artificial flavoring and characterizing food ingredients.(C) The optional sweetening ingredients referred to in subparagraph (A) of this paragraph are sugar (sucrose), dextrose, invert sugar (paste or syrup), glucose syrup, dried glucose syrup, corn sweetener, dried corn sweetener, malt syrup, malt extract, dried malt syrup, dried malt extract, maltose syrup and dried maltose syrup.(D) Other optional ingredients referred to in subparagraph (A) of this paragraph are: (i) casein prepared by precipitation with gums, ammonium, caseinate, calcium caseinate, potassium caseinate, or sodium caseinate;(ii) hydrogenated and partially hydrogenated vegetable oil;(iii) dipotassium phosphate;(iv) coloring, including artificial coloring;(v) monoglycerides, diglycerides, or polysorbates; and(vi) thickening ingredients such as agar-agar, algin (sodium alginate), egg white, gelatin, gum acacia, guar seed gum, gum karaya, locus bean gum, oat gum, gum tragacanth, hydroxypropyl, cethyl cellulose, carrageenan, salts of carrageenan, furcelleran, salts of furcelleran, propulene glycol alginate, pectin, psyllium seed husk, and sodium carvoxymethylcellulose.(E) Such nondairy frozen desserts are deemed "processed" when manufactured as a dry powdered mix. The addition of water is merely the manner in which such nondairy frozen desserts are served.(F) The label shall comply with labeling requirements for frozen desserts with the additional clear and concise statement that the product is nondairy.(68) Nonfat yogurt--The food produced by culturing skim milk, used alone or in combination with a characterizing bacterial culture that contains the lactic acid-producing bacteria, Lactobacillus bulgaricus and Streptococcus thermophilus. Nonfat yogurt is further defined in Title 21, CFR, §131.206.(69) Non-grade A dairy product manufacturer--Any place, premise, or establishment where dairy products are produced or prepared for distribution for human consumption but is not subject to Grade A requirements.(70) Novelties--Frozen desserts, either alone or in combination with other foods such as cookies, wafers, cones, coating, confections, etc., which are packaged in single-serving units.(71) Official laboratory--A biological, chemical or physical laboratory which is under the supervision of the department conducting the analysis of milk, milk products, milk for manufacturing, or frozen dessert. Full service laboratories are official laboratories.(72) Officially designated laboratory--A commercial laboratory or a milk industry laboratory officially designated by the department for the analysis of milk, milk products, milk for manufacturing, or frozen desserts.(73) Overrun--The increase in volume of frozen product over the volume of the mix due to air being whipped into the product during the freezing process. It is expressed as a percent of the volume of the mix.(74) Pasteurization-- (A) The process of heating every particle of milk or milk product, in properly designed and operated equipment, and held continuously at or above a certain temperature for at least the corresponding specified time referenced in the most current revision of the "Grade A Pasteurized Milk Ordinance."(B) Provided further, that nothing shall be construed as barring any other process found equivalent to pasteurization for milk and milk products, which has been recognized by the FDA as provided in 21 U.S.C. § 343(h)(3) of the Federal Food, Drug and Cosmetic Act. Only such FDA recognized processes and no other shall be considered by the department.(75) Permit--A license or certification to engage in the activity listed on the permit, license, or certificate.(76) Person--The word "person" shall include any individual, plant operator, partnership, corporation, company, firm, trustee, association, or institution.(77) Principal Display Panel--The part of a label that is most likely to be displayed, presented, shown, or examined under normal and customary conditions of display for retail sale.(78) Producer dairy farm--Any place or premises where one or more lactating animals (cows, goats or sheep, water buffalo, or other hooved animal) 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, transfer station, receiving station, frozen dessert manufacturer, or non-grade A dairy product manufacturer.(79) Quiescently frozen confection--A clean and wholesome frozen, sweetened, flavored product in the manufacture of which freezing has not been accompanied by stirring or agitation (generally known as quiescent freezing). This confection may be acidulated with food grade acid, may contain water, may be made with or without added natural or artificial flavoring, and with or without harmless coloring. The finished product contains not less than 17% by weight of total food solids. No processing or mixing shall be used that develops in the finished food mix any physical expansion in excess of 10%.(80) Quiescently frozen dairy confection--A clean and wholesome frozen product made from water, milk products and sugar, with added harmless natural or artificial flavoring, with or without added coloring, with or without added stabilizer, with or without added emulsifier; and in the manufacture of which freezing has not been accompanied by stirring or agitation (generally known as quiescent freezing). It contains not less than 13% by weight of total milk solids, and not less than 33% by weight of total food solids. In the production of quiescently frozen dairy confections, no processing or mixing before quiescently freezing is used that develops in the finished confection mix any physical expansion in excess of 10%.(81) Receiving station--Any place, premises, or establishment where raw milk is received, collected, handled, stored, or cooled and prepared for further transporting.(82) Reconstituted or recombined milk and milk products--Milk or milk products defined in this section which result from reconstituting or recombining of milk constituents with potable water when appropriate.(83) Regulatory agency--The Department of State Health Services. For purposes of this chapter, Texas Department of Health is an equivalent term.(84) Safe and suitable--Ingredients which perform an appropriate function in the food in which they are used, and are used at a level no higher than necessary to achieve their intended purpose in the food.(85) Sale--The term "sale" or "sell" means a monetary transaction, barter, offer, or trade that involves the transfer of milk, milk products, raw milk, raw milk products, dairy products, or frozen dessert products. The term also includes transactions conducted as part of animal shares or animal pools, unless it involves the transfer of milk from the farmer to a person holding an ownership interest in the producing animals, who shares costs in proportion to their ownership interest, and only receives milk in proportion to their ownership interest as memorialized in a written agreement.(86) Sanitization--The application of any effective method or substance to a clean surface for the destruction of pathogens and other organisms as far as is practicable. Such treatment shall not adversely affect the equipment, the milk or milk product, or the health of consumers, and shall be acceptable to the regulatory agency.(87) Sherbet--The food defined in Title 21, CFR, §135.140.(88) Single service container--Any container having a milk product or frozen dessert, in contact with the containers surface and used in the packaging, handling, storing, or serving frozen desserts and/or milk products, which is intended for one usage only.(89) Sour cream or cultured sour cream--The product resulting from the souring, by lactic acid producing bacteria, of pasteurized cream, and as further defined in Title 21, CFR, §131.160.(90) Standard methods--Reference to the latest edition of "Standard Methods for the Examination of Dairy Products," a publication of the American Public Health Association, Washington, D.C.(91) Sterilized--The condition of piping equipment and containers achieved by the application of heat, chemical sterilant(s), or other appropriate treatment that renders the piping, equipment, and containers free of viable microorganisms.(92) 3-A Sanitary Standards and Accepted Practices--The standards for dairy equipment and accepted practices formulated by the 3-A Steering Committee representing the International Association for Food Protection, the U.S. Public Health Service, and the Dairy Industry Committee that are published by the International Association of Milk, Food, and Environmental Sanitarians, 6200 Aurora Avenue, #200W, Des Moines, Iowa 50322.(93) 3-A Steering Committee--The committee composed of appointees from the International Association for Food Protection, and the Food and Drug Administration/Public Health Service that reviews and establishes standards for production and processing equipment intended for use in this country.(94) Thermometer--A temperature measuring device that is either mercury-in-glass, alcohol/spirit-in-glass, electronic/digital, or dial immersed in liquid and accurate within the appropriate range of designated use.(95) Transfer station--Any place, premises, or establishment where milk or milk products are transferred directly from one milk tank truck to another.(96) Ultra-pasteurized--The term "ultra-pasteurized," when used to describe a dairy product, means that such product shall have been thermally processed at or above 138 degrees Celsius (280 degrees Fahrenheit) for at least two seconds, either before or after packaging, so as to extend a product shelf life under refrigerated conditions.(97) Unloading station--Any receiving station, transfer station, or milk processing plant where milk or milk products are unloaded from milk tank trucks.(98) Water ices--The foods defined in Title 21, CFR, §135.160.(99) Whipped cream--Cream or light whipping cream, into which air or gas has been incorporated.(100) Whipped light cream--Light cream into which air or gas has been incorporated.(101) Yogurt--The food produced by culturing cream, milk, partially skimmed milk, or skim milk, used alone or in combination with a characterizing bacterial culture that contains the lactic acid-producing bacteria, Lactobacillus bulgaricus and Streptococcus thermophilus. Yogurt is further defined in Title 21, CFR, §131.200.25 Tex. Admin. Code § 217.1
The provisions of this §217.1 adopted to be effective July 4, 2010, 35 TexReg 3038; Amended by Texas Register, Volume 46, Number 20, May 14, 2021, TexReg 3130, eff. 5/17/2021