01-001-329 Me. Code R. § I

Current through 2024-52, December 25, 2024

Section 001-329-I - GENERAL

Any person, firm or corporation required to hold a valid permit or license under 7 MRS, Chapter 601, Milk and Milk Products, §2901-C or §2902-A must comply with this rule and in addition any person, firm or corporation which participates in the State/United States Public Health Service/Food and Drug Administration (USPHS/FDA) voluntary Cooperative Program for the Certification of Interstate Milk Shippers (IMS program) must comply with all requirements and is subject to the administrative procedures outlined in the 2019 USDA Grade "A" Pasteurized Milk Ordinance herein referred to as the "PMO". All further references to "PMO" in this Rule mean the 2019 edition of the PMO. LINK: https://www.fda.gov/food/milk-guidance-documents-regulatory-information/national-conference-interstate-milk-shipments-ncims-model-documents

A. DEFINITIONS

1. ABNORMALITIES OF MILK: The following types of lacteal secretions are not suitable for sale for human consumption:

(a) Abnormal Milk: Milk that is visibly changed in color, odor, and/or texture.

(b) Undesirable Milk: Milk that, prior to the milking of the animal, is expected to be unsuitable for sale, such as milk containing colostrum.

(b) Contaminated Milk: Milk that is un-saleable or unfit for human consumption following treatment of the animal with veterinary products, i.e. antibiotics, which have withhold requirements, or treatment with medicines or insecticides not approved for use on dairy animals by FDA or the Environmental Protection Agency (EPA).

2. ACIDIFIED MILK -

(a) "Acidified milk" is the food produced by souring one or more of the optional dairy ingredients specified in paragraph (c) of this Section with one or more of the acidifying ingredients specified in paragraph (d) of this Section, with or without the addition of characterizing microbial organisms. One or more of the other optional ingredients specified in paragraph (b) and (e) of this Section may also be added. When one or more of the ingredients specified in paragraph (e)(i) of this Section are used, they must be included in the souring process. All ingredients used are safe and suitable. Acidified milk contains not less than 3.25 percent milk fat and not less than 8.25 percent milk solids not fat and has a titratable acidity of not less than 0.5 percent, expressed as lactic acid. The food may be homogenized and may be pasteurized or ultra-pasteurized prior to the addition of the microbial culture and, when applicable, the addition of flakes or granules of butterfat or milk fat.

(b) Vitamin addition requirements (optional)

(i) If added, vitamin A must be present in such quantity that each 946 milliliters (1-quart) of the food contains not less than 2,000 International Units thereof, within limits of good manufacturing practice.

(ii) If added, vitamin D must be present in such quantity that each 946 milliliters (1-quart) of the food contains 400 International Units thereof, within limits of good manufacturing practice.

(c) Optional dairy ingredients: Cream, milk, partially skimmed milk, or skim milk, used alone or in combination.

(d) Optional acidifying ingredients: Acetic acid, adipic acid, citric acid, fumaric acid, glucono-delta-lactone, hydrochloric acid, lactic acid, malic acid, phosphoric acid, succinic acid, and tartaric acid.

(e) Other optional ingredients.

(i) Concentrated skim milk, nonfat dry milk, buttermilk, whey, lactose, lactalbumins, lactoglobulins, or whey modified by partial or complete removal of lactose and/or minerals, to increase the nonfat solids content of the food: provided, that the ratio of protein to total nonfat solids of the food, and the protein efficiency ratio of all protein present, must not be decreased as a result of adding such ingredients.

(ii) Nutritive carbohydrate sweeteners. Sugar (sucrose), beet or cane; invert sugar (in paste or syrup form); brown sugar; refiner's syrup; molasses (other than blackstrap); high fructose corn syrup; fructose; fructose syrup; maltose; maltose syrup, dried maltose syrup; malt extract; dried malt extract; malt syrup, dried malt syrup; honey; maple sugar; or any other sweeteners listed in 21 CFR Part 168 (2016), except table syrup.

(iii) Flavoring ingredients.

(iv) Color additives that do not impart a color simulating that of milk fat or butterfat.

(v) Stabilizers.

(vi) Butterfat or milk fat, which may or may not contain color additives, in the form of flakes or granules.

(vii) Aroma- and flavor-producing microbial culture.

(viii) Salt.

(ix) Citric acid, in a maximum amount of 0.15 percent by weight of the dairy ingredients used, or an equivalent amount of sodium citrate, as a flavor precursor.

3. ACIDIFIED SOUR CREAM -

(a) "Acidified sour cream" is the result of the souring of pasteurized cream with safe and suitable acidifiers, with or without addition of lactic acid producing bacteria. Acidified sour cream contains not less than 18 percent milk fat; except that when the food is characterized by the addition of nutritive sweeteners or bulky flavoring ingredients, the weight of the milk fat is not less than 18 percent of the remainder obtained by subtracting the weight of such optional ingredients from the weight of the food; but in no case does the food contain less than 14.4 percent milk fat. Acidified sour cream has a titratable acidity of not less than 0.5 percent, calculated as lactic acid.

(b) Optional ingredients.

(i) Safe and suitable ingredients that improve texture, prevent syneresis, or extend the shelf life of the product.

(ii) Rennet.

(iii) Safe and suitable nutritive sweeteners.

(iv) Salt.

(v) Flavoring ingredients, with or without safe and suitable coloring as follows:

(a) Fruit and fruit juice, including concentrated fruit and fruit juice.

(b) Safe and suitable natural and artificial food flavoring.

4. ACIDIFIED SOUR HALF-AND-HALF -

(a) "Acidified sour half-and-half" is the result of the souring of pasteurized half-and-half with safe and suitable acidifiers, and with or without addition of lactic acid producing bacteria. Acidified sour half-and-half contains not less than 10.5 percent but less than 18 percent milk fat; except that when the food is characterized by the addition of nutritive sweeteners or bulky flavoring ingredients, the weight of the milk fat is not less than 10.5 percent of the remainder obtained by subtracting the weight of such optional ingredients from the weight of the food; but in no case does the food contain less than 8.4 percent milk fat. Acidified sour half-and-half has a titratable acidity of not less than 0.5 percent, calculated as lactic acid.

(b) Optional ingredients.

(i) Safe and suitable ingredients to improve texture, prevent syneresis, or extend the shelf life of the product.

(ii) Rennet.

(iii) Safe and suitable nutritive sweeteners.

(iv) Salt.

(v) Flavoring ingredients, with or without safe and suitable coloring, as follows:

(c) Fruit and fruit juice, including concentrated fruit and fruit juice.

(d) Safe and suitable natural and artificial food flavoring.

5. ADULTERATED MILK AND MILK PRODUCTS -

Any milk or milk product shall be deemed to be adulterated:

(a) If it bears or contains any poisonous or deleterious substance (such as an emerging contaminant) which may render it injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health; or

(b) If it bears or contains any added poisonous or added deleterious substance (other than one which is (i) a pesticide chemical in or on a raw agricultural commodity; (ii) a food additive; (iii) a color additive; or (iv) any animal drug) which is unsafe within the meaning of Section 406 of the Federal Food, Drug and Cosmetic Act ( 21 U.S.C. section 342(a)(1) (2005)) (hereinafter referred to as FD&C), or

(c) If it is a raw agricultural commodity and it bears or contains a pesticide chemical which is unsafe within the meaning of Section 408(a) of the FD&C( 21 U.S.C. section 346a (2019)); or

(d) If it is, or it bears or contains, any food additive which is unsafe within the meaning of Section 409 of the FD&C( 21 U.S.C. section 348 (2018)): provided, that where a pesticide chemical has been used in or on a raw agricultural commodity in conformity with an exemption granted or a tolerance prescribed under Section 408 of the FD&C ( 21 U.S.C. section 346a (2019)) and such raw agricultural commodity has been subjected to processing such as canning, cooking, freezing, dehydrating, milling, the residue of such pesticide chemical remaining in or on such processed food shall, notwithstanding the provisions of Section 406 and 409 of the FD&C ( 21 U.S.C. section 346a (2019) and 21 U.S.C. section 348 (2018)), not be deemed unsafe if such residue in or on the raw agricultural commodity has been removed to the extent possible in good manufacturing practice and the concentration of such residue in the processed food when ready to eat is not greater than the tolerance prescribed for the raw agricultural commodity; or

(e) If it is, or it bears or contains, any animal drug (or conversion product thereof) which is unsafe within the meaning of Section 512 of the FD&C ( 21 U.S.C. section 360b (2018)); or

(f) If it consists in whole or in part of any filthy, putrid or decomposed substance, or if it is otherwise unfit for food; or

(g) If it has been prepared, packed, or held under unsanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health; or

(h) If it is, in whole or in part, the product of a diseased animal or of an animal which has died otherwise than by slaughter; or

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

(j) If it has been intentionally subjected to radiation, unless the use of radiation was in conformity with a regulation or exemption in effect pursuant to Section 409 of the FD&C ( 21 U.S.C. section 348 (2018)); or

(k) If any valuable constituent has been in whole or in part omitted or abstracted therefrom; or (ii) if any substance has been substituted wholly or in part therefor; or (iii) if damage or inferiority has been concealed in any manner; or (iv) if 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; or

(l) If it is, or it bears or contains, a color additive which is unsafe within the meaning of Section 706(a) of the FD&C ( 21 U.S.C. section 379e (1993); or

(m) If it is confectionery, and -

(i) has partially or completely imbedded therein any non-nutritive object: provided, that this clause shall not apply in the case of any non-nutritive object if such object is of practical functional value to the confectionery product and would not render the product injurious or hazardous to health;

(ii) bears or contains any alcohol other than alcohol not in excess of one-half of 1 percent by volume derived solely from the use of flavoring extracts; or

(iii) bears or contains any non-nutritive substance: provided, that this clause shall not apply to a safe non-nutritive substance which is in or on confectionery by reason of its use for some practical functional purpose in the manufacture, packaging or storage of such confectionery if the use of the substance does not promote deception of the consumer or otherwise result in adulteration or misbranding in violation of any provision of this rule: and provided further that the Commissioner may, for the purpose of avoiding or resolving uncertainty as to the application of this clause, issue regulations allowing or prohibiting the use of particular non-nutritive substances; or

(n) If it is oleomargarine or margarine or butter and any of the raw material used therein consisted in whole or in part of any filthy, putrid, or decomposed substance, or such oleomargarine or margarine or butter is otherwise unfit for food.

6. AND/OR - Where the term "and/or" is used, "and" shall apply where appropriate; otherwise "or" shall apply.

7. ASEPTIC PROCESSING - "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 113 and the provisions of Section V and maintain the commercial sterility of the product under normal non-refrigerated conditions.

8. ASEPTICALLY PROCESSED MILK AND MILK PRODUCTS- "Aseptically processed milk and milk products" are products that have been subjected to sufficient heat processing and packaged in a hermetically sealed container, to conform to the applicable requirements of Title 21 CFR 113 and the provisions of Section V and to maintain the commercial sterility of the product under normal non-refrigerated conditions.

9. AUTOMATIC MILKING INSTALLATION (AMI) - The term "automatic milking installation" covers the entire installation of one or more automatic 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 sanitation.

10. BULK MILK HAULER/SAMPLER - A "bulk milk hauler/sampler" is any person who collects official samples and/or transports raw milk from a farm and/or raw milk products to or from a farm, milk plant, receiving station or transfer station and has in their possession a permit from any state to sample such products.

11. BULK MILK PICKUP TANKER - A "bulk milk pickup tanker" is a vehicle, including the truck, tank and those appurtenances necessary for its use, used by the bulk milk hauler/sampler or milk tank truck driver to transport bulk raw milk for pasteurization or processing from a dairy farm to a milk plant, receiving station or transfer station.

12. BUTTER - "Butter" means the food product which is made exclusively from milk or cream or both, with or without common salt, and with or without additional coloring matter, and containing not less than 80% by weight of milk fat.

13. BUTTERMILK - "Buttermilk" is a fluid product resulting from the manufacture of butter from milk or cream. It contains not less than 8 1/4 percent of milk solids not fat.

(a) Dry Buttermilk: Grade "A" dry buttermilk means dry buttermilk, which complies with the applicable provisions of this Rule.

(b) Dry Buttermilk Products: Grade "A" dry buttermilk products means dry buttermilk products, which comply with the applicable provisions of this Rule.

(c) Concentrated (Condensed) Buttermilk: Concentrated (condensed) buttermilk means the product resulting from the removal of a considerable portion of water from buttermilk.

(d) Concentrated (Condensed) and Dry Buttermilk and Buttermilk Products: Grade "A" concentrated (condensed) and dry buttermilk and buttermilk products means concentrated (condensed) or dry buttermilk and buttermilk products, which comply with the applicable provisions of this Rule. The words "concentrated (condensed) and dry milk products" shall be interpreted to include concentrated (condensed) and dry buttermilk and buttermilk products.

14. CHEESE - "Cheese" is the consolidated curd of milk used as an article of food.

15. CLEAN- "Clean" means that direct product contact surfaces have had the effective and thorough removal of product and/or contaminants.

16. CLEAN-IN-PLACE (CIP) CLEANING- "Clean-in-place (CIP) cleaning" means the removal of soil from product contact surfaces in their process position by circulating, spraying, or flowing chemical solutions and water rinses onto and over the surfaces to be cleaned. Components of the equipment, which are not designed to be cleaned-in-place, are removed from the equipment to be cleaned out-of-place (COP) or manually cleaned. Product contact surfaces must be inspectable, except when the cleanability by CIP has been documented and accepted by the Department. In such accepted equipment, all product and solution contact surfaces do not have to be readily accessible for inspection, i.e., permanently installed pipelines and silo tanks.

17. COMMISSIONER - "Commissioner" means the Commissioner of the Maine Department of Agriculture, Conservation and Forestry or his/her duly authorized agent.

18. COMMON NAME- "Common name" means the generic term commonly used for domestic animals, i.e., cattle, goats, sheep, horses, water buffalo, etc.

19. CONCENTRATED (CONDENSED) MILK - "Concentrated (condensed) milk" means 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 with the milk fat and milk solids not fat levels of milk as defined in this section.

(a) Concentrated (Condensed) Milk Products: "Concentrated (condensed) milk products" means and includes homogenized concentrated (condensed) milk, concentrated (condensed) skim milk, concentrated (condensed) reduced fat or low-fat milk, and similar concentrated (condensed) products made from concentrated (condensed) milk or concentrated (condensed) skim milk, which when combined with potable water in accordance with instructions printed on the container label, conform with the definitions of the corresponding milk products in this Section.

(b) Grade "A" Concentrated (Condensed) Skim Milk: "Grade "A" concentrated (condensed) skim milk" means concentrated (condensed) skim milk, which complies with the applicable provisions of the PMO.

20. COOLING POND -"Cooling Pond" means a man-made structure designed for the specific purpose of cooling cows.

21. COTTAGE CHEESE -

(a) "Cottage cheese" means the soft uncured cheese prepared by mixing cottage cheese dry curd with a creaming mixture as provided in paragraph (b) of this Section. The milk fat content is not less than 4 percent by weight of the finished food, within limits of good manufacturing practice. The finished food contains not more than 80 percent of moisture.

(b) The creaming mixture is prepared from safe and suitable ingredients including, but not limited to, milk or substances derived from milk. Any ingredients used that are not derived from milk must serve a useful function other than building the total solids content of the finished food and shall be used in a quantity not greater than is reasonably required to accomplish their intended effect. The creaming mixture may be pasteurized; however, heat labile ingredients, such as bacterial starters, may be added following pasteurization.

(c) The name of the food consists of the following two phrases which must appear together:

(i) The words "cottage cheese" which must appear in type of the same size and style.

(ii) The statement "not less than... percent milk fat" or "... percent milk fat minimum", the blank being filled in with the whole number that is closest to, but does not exceed, the actual fat content of the product. This statement of fat content must appear in letters not less than one-half of the height of letters in the phrase specified in paragraph (c)(i) of this Section, but in no case less than one-eighth of an inch in height.

(d) When the optional process described in Title 21 CFR 133 (2019) is used to make the cottage cheese dry curd, the label must bear the statement "directly set" or "Curd set by direct acidification". Wherever the name of the food appears on the label so conspicuously as to be seen under customary conditions of purchase, the statement specified in this paragraph, showing the optional process used must immediately and conspicuously precede or follow such name without intervening written, printed, or graphic matter.

(e) The common or usual name of each of the ingredients used in the food must be declared on the label as required by the applicable sections. Except that:

(i) Concentrated milk, dried milk, and reconstituted milk prepared by addition of water to concentrated milk or dried milk may be declared as "milk".

(ii) Concentrated skim milk, nonfat dry milk, and reconstituted skim milk prepared by addition of water to concentrated skim milk or nonfat dry milk may be declared as "skim milk".

(iii) Bacterial cultures may be declared by the word "cultured" followed by the name of the substrate, e.g., "made from cultured skim milk".

(iv) Milk-clotting enzymes may be declared by the word "enzymes".

22. CREAM - "Cream" means the liquid milk product high in fat separated from milk, which may have been adjusted by adding thereto: Milk, concentrated milk, dry whole milk, skim milk, concentrated skim milk, or nonfat dry milk. Cream contains not less than 18 percent milk fat.

23. CULTURED MILK -

(a) "Cultured milk" is the food produced by culturing one or more of the optional dairy ingredients specified in paragraph (c) of this Section with characterizing microbial organisms. One or more of the other optional ingredients specified in paragraphs (b) and (d) of this Section may also be added. When one or more of the ingredients specified in paragraph (d)(i) of this Section are used, they must be included in the culturing process. All ingredients used are safe and suitable. Cultured milk contains not less than 3.25 percent milk fat and not less than 8.25 percent milk solids not fat and has a titratable acidity of not less than 0.5 percent, expressed as lactic acid. The food may be homogenized and may be pasteurized or ultra-pasteurized prior to the addition to the microbial culture, and when applicable, the addition of flakes or granules of butterfat or milk fat.

(b) Vitamin addition requirements (optional).

(i) If added, vitamin A must be present in such quantity that each 946 milliliters (1-quart) of the food contains not less than 2,000 International Units thereof within limits of good manufacturing practice.

(ii) If added, vitamin D must be present in such quantity that each 946 milliliters (1-quart) of the food contains 400 International Units thereof, within limits of good manufacturing practice.

(c) Optional dairy ingredients. Cream, milk, partially skimmed milk, or skim milk, used alone or in combination.

(d) Other optional ingredients.

(ii) Nutritive carbohydrate sweeteners. Sugar (sucrose), beet or cane; invert sugar (in paste or syrup form); brown sugar; refiner's syrup; molasses (other than blackstrap); high fructose corn syrup; fructose; fructose syrup; maltose; maltose syrup, dried maltose syrup; malt extract, dried malt extract; malt syrup, dried malt syrup; honey; maple sugar; or any other sweetener listed in 21 CFR Part 168, except table syrup.

(iii) Flavoring ingredients.

(iv) Color additives that do not impart a color simulating that of milk fat or butterfat.

(v) Stabilizers.

(vi) Butterfat or milk fat, which may or may not contain color additives, in the form of flakes or granules.

(vii) Aroma- and flavor-producing microbial culture.

(viii) Salt.

(ix) Citric acid, in a maximum amount of 0.15 percent by weight of the milk used, or an equivalent amount of sodium citrate, as a flavor precursor.

24. DAIRY FARM - "Dairy farm" means any place or premises where one (1) or more cows, goats, sheep, water buffalo, or other hooved mammal are kept for milking purposes, and from which a part or all of the milk or milk product(s) is provided, sold or offered for sale to a milk plant, receiving or transfer station.

(Refer to the NOTE: at the end of Section XIII )

25. DAIRY PLANT SAMPLER - "Dairy plant sampler" means an individual responsible for the collection of official samples for regulatory purposes outlined in this Rule. This person is an employee of the Department or an official designee of the Department and is evaluated every two years by the State Sample Surveillance Officer. Sampling Surveillance Officers or properly delegated Sampling Surveillance Regulatory Officials are not required to be evaluated for sampling collection procedures.

26. DEPARTMENT - "Department" means the Maine Department of Agriculture, Conservation & Forestry.

27. DRUG - The term "drug" means:

(a) Articles recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States or official National Formulary or any supplement to any of them; and

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

(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 clause (a), (b) or (c), but does not include devices or their components, parts or accessories.

28. DRY CURD COTTAGE CHEESE -

(a) "Dry curd cottage cheese" is the soft uncured cheese prepared by the procedure set forth in paragraph (b) of this Section. The finished food contains less than 0.5 percent milk fat. It contains not more than 80 percent of moisture.

(b) Preparation Procedures:

(i) One or more of the dairy ingredients specified in paragraph (b)(ii) of this section is pasteurized; calcium chloride may be added in a quantity of not more than 0.02 percent (calculated as anhydrous calcium chloride) of the weight of the mix; thereafter one of the following methods is employed:

(a) Harmless lactic-acid-producing bacteria, with or without rennet and/or other safe and suitable milk clotting enzyme that produces equivalent curd formation, are added and it is held until it becomes coagulated. The coagulated mass may be cut; it may be warmed; it may be stirred; it is then drained. The curd may be washed with water and further drained; it may be pressed, chilled, worked, seasoned with salt; or

(b) Food grade phosphoric acid, lactic acid, citric acid, or hydrochloric acid, with or without rennet and/or other safe and suitable milk-clotting enzyme that produces equivalent curd formation, is added in such amount as to reach a pH of between 4.5 and 4.7; coagulation to a firm curd is achieved while heating to a maximum of 48.9°C (120°F) without agitation during a continuous process. The coagulated mass may be cut; it may be warmed; it may be stirred; it is then drained. The curd is washed with water, stirred, and further drained. It may be pressed, chilled, worked and seasoned with salt.

(c) Food grade acids as provided in paragraph (b)(i)(b) of this Section, D-Glucono- delta-lactone with or without rennet, and/or other safe and suitable milk clotting enzyme that produces equivalent curd formation, are added in such amounts as to reach a final pH value in the range of 4.5-4.8, and it is held until it becomes coagulated. The coagulated mass may be cut; it may be warmed; it may be stirred; it is then drained. The curd is then washed with water, and further drained. It may be pressed, chilled, worked, and seasoned with salt.

(ii) The dairy ingredients referred to in paragraph (b)(i) of this Section are sweet skim milk, concentrated skim milk, and nonfat dry milk. If concentrated skim milk or nonfat dry milk is used, water may be added in a quantity not in excess of that removed when the skim milk was concentrated or dried.

(iii) For the purposes of this Section the term "skim milk" means the milk of cows from which the milk fat has been separated, and "concentrated skim milk" means skim milk from which a portion of the water has been removed by evaporation.

(c) The name of the food consists of the following two phrases which must appear together:

(i) The words "cottage cheese dry curd" or alternatively "dry curd cottage cheese" which must all appear in type of the same size and style.

(ii) The words "less than 1/2% milk fat" which must all appear in letters not less than one-half of the height of the letters in the phrase specified in paragraph (c)(i) of this Section, but in no case less than one-eighth of an inch in height.

(d) When either of the optional processes described in paragraph (b)(i) (b) or (c) of this Section is used, the label must bear the statement "Directly set" or "Curd set by direct acidification". Wherever the name of the food appears on the label so conspicuously as to be seen under customary conditions of purchase, the statement specified in this paragraph, showing the optional process used, must immediately and conspicuously precede or follow such name without intervening written, printed, or graphic matter.

(e) The common or usual name of each of the ingredients used in the food must be declared on the label as required in Section XIV of this rule, except that:

(i) Concentrated skim milk, nonfat dry milk, and reconstituted skim milk prepared by addition of water to concentrated skim milk or nonfat dry milk may be declared as "skim milk".

(ii) Bacterial cultures may be declared by the word "cultured" followed by the name of the substrate, e.g., "made from cultured skim milk".

(iii) Milk-clotting enzymes may be declared by the word "enzymes".

29. EGGNOG -

(a) "Eggnog" is the food containing one or more of the optional dairy ingredients specified in paragraph (b), one or more of the optional egg yolk-containing ingredients specified in paragraph (c) of this Section, and one or more of the optional nutritive carbohydrate sweeteners specified in paragraph (d) of this Section. One or more of the optional ingredients specified in paragraph (e) of this Section may also be added. All ingredients used are safe and suitable. Eggnog contains not less than 6 percent milk fat and not less than 8.25 percent milk solids not fat. The egg yolk solids content is not less than 1 percent by weight of the finished food. The food must be pasteurized or ultra-pasteurized and may be homogenized. Flavoring ingredients and color additives may be added after the food is pasteurized or ultra-pasteurized.

(b) Optional dairy ingredients. Cream, milk, partially skimmed milk, or skim milk, used alone or in combination.

(c) Egg Yolk-containing ingredients. 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 ingredients with liquid egg whites or frozen egg whites. Whenever eggs or egg yolk solids are used as an ingredient, they must be pasteurized or, if not, the mix must be pasteurized after the eggs or egg yolk solids are added.

(d) Nutritive carbohydrate sweeteners. Sugar (sucrose), beet or cane; invert sugar (in paste or syrup form); brown sugar; refiner's syrup; molasses (other than blackstrap); high fructose corn syrup; fructose, fructose syrup; maltose; maltose syrup, dried maltose syrup; malt extract, dried malt extract; malt syrup, dried malt syrup; honey; maple sugar; or any of the sweeteners listed in 21 CFR Part 168, except table syrup.

(e) Other optional ingredients.

(ii) Salt.

(iii) Flavoring ingredients.

(iv) Color additives that do not impart a color simulating that of egg yolk, milk fat or butterfat.

(v) Stabilizers.

30. FDA - Food & Drug Administration, an agency with the United States Department of Health and Human Services. The core functions of this agency are oversight of Medical Products and Tobacco, Foods, Global Regulatory Operations and Policy, and Operations.

31. FD&C - Food, Drug, and Cosmetic Act: A set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics.

32. FALSE POSITIVE - In reference to antibiotic screening of bulk tanker milk and bulk tank milk, "false positive" means that, on subsequent testing by high pressure chromatograph (HPLC), antibiotic residue was not found to be present.

33. FALSE VIOLATIVE - In reference to antibiotic screening of bulk tanker milk or bulk tank milk, "false violative" means that on subsequent testing by high pressure liquid chromatograph, antibiotic residue was found to be present at below the FDA-established safe or tolerance level.

34. FOOD ALLERGENS - Are proteins in foods that are capable of inducing an allergic reaction or response in some individuals. There is scientific consensus that the following foods account for more than 90% of all food allergies: peanuts, soybeans, milk, eggs, fish, crustacea, tree nuts, and wheat.

35. FROZEN MILK CONCENTRATE - "Frozen milk concentrate" is a frozen milk product with a composition of milk fat 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 milk fat 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.

36. FROZEN YOGURT -

(a) "Frozen yogurt" is the food which is prepared by freezing while stirring a pasteurized mix consisting of the ingredients identified for ice cream. Safe and suitable sweetening agents may be used. Such ingredients are cultured after pasteurization by one or more strains of lactobacillus bulgaricus and streptococcus thermophilus, provided, however, fruit, nuts, or other flavoring materials may be added before or after the mix is pasteurized and cultured. The standard plate count requirement for frozen desserts shall apply to the mix prior to culturing. Frozen yogurt, exclusive of any flavoring contains not less than 3.25 percent milk fat, not less than 8.25 percent milk solids not fat and has a titratable acidity of not less than 0.3 percent expressed as lactic acid. Where the titratable acidity of the frozen yogurt is less than 0.3 percent, the manufacturer may establish compliance with this section by disclosing to the Department its quality control records that demonstrate as a result of bacterial culture fermentation, at least a 0.15 percent increase in titratable acidity calculated as lactic acid, above the apparent titratable acidity of the uncultured dairy ingredients in the frozen yogurt mix. The direct addition of food grade acids or other acidogens for the purpose of raising the titratable acidity of the frozen yogurt mix to comply with the prescribed minimum is not permitted; and no chemical preservative treatment or other preservation process, other than refrigeration, may be utilized that results in reduction of the live culture. Sweetener(s), flavoring(s) and/or other characterizing food ingredients may be added to the mix before or after pasteurization or ultra-pasteurization is done in accordance with good manufacturing practice. The finished yogurt must weigh not less than 4 pounds per gallon. Any dairy ingredients added after pasteurization or ultra-pasteurization must have been pasteurized.

(b) The name of the food is "frozen yogurt". In addition to all other required information, the label must contain a complete list of ingredients, in accordance with the provisions of 21 CFR 101.4, and comply with the provisions of subdivisions (h) and (i) of 21 CFR 101.22. On the label of frozen yogurt the strains of bacteria may be collectively referred to as yogurt culture.

37. GOAT MILK - "Goat milk" is 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 must contain not less than 2.5 percent milk fat and not less than 7.5 percent milk solids not fat. Goat milk and goat milk food products must be produced according to the sanitary standards of this rule.

38. GOAT'S MILK ICE CREAM -

(a) "Goat's milk ice cream" is the food prepared in the same manner prescribed in 21 CFR 135, and complies with all the provisions of 21 CFR 135, except that the only optional dairy ingredients that may be used are those in paragraph (b) of this Section; caseinates and hydrolyzed milk proteins may not be used; and paragraph (f)(1) and (g) of Sec. 135.110 shall not apply.

(b) Optional dairy ingredients. The optional dairy ingredients referred to in paragraph (a) of this Section are goat's skim milk, goat's milk, and goat's cream. These optional dairy ingredients may be used in liquid, concentrated, and/or dry form.

(c) If eggs or egg yolk solids are used as an ingredient, they must be pasteurized or, if not, the mix must be pasteurized after the eggs or egg yolk solids are added.

39. GRADE A MILK AND MILK PRODUCTS "Grade A milk and milk products" are products that have been manufactured under and comply with all applicable provisions of the PMO. All such products are pasteurized or are destined for pasteurization.

40. GRADE A DRY MILK AND WHEY PRODUCTS - "Grade A dry milk and whey products" are 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 Grade A Condensed and Dry Milk Products and Condensed and Dry Whey-Supplement to comply with all applicable provisions of the PMO.

41. GRAS - "GRAS" means generally recognized as safe as defined by 21 CFR Part 184 (2016).

42. HACCP - "HACCP" means Hazard Analysis and Critical Control Point. It is a food safety control system based on technical and scientific principles that assure safe food.

43. HALF-AND-HALF-

(a) "Half-and-half" is the food consisting of a mixture of milk and cream which contains not less than 10.5 percent but less than 18 percent milk fat. It may be homogenized.

(b) Optional ingredients. The following safe and suitable optional ingredients may be used.

(i) Emulsifiers.

(ii) Stabilizers.

(iii) Nutritive sweeteners.

(iv) Characterizing flavoring ingredients (with or without safe and suitable coloring) as follows:

(a) Fruit and fruit juice (including concentrated fruit and fruit juice)

(b) Natural and artificial food flavoring.

44. HEAT TREATED-

"Heat treated" or "heat-treated" or "heat treatment" means processed by heating every particle of milk to a temperature of 145 degrees Fahrenheit for at least 30 minutes. Other heat treatment processes of differing temperature and time combinations may be acceptable if validated through a heat treatment study by a food processing authority.

45. HEAVY CREAM OR HEAVY WHIPPING CREAM-

(a) "Heavy cream" is cream which contains not less than 36 percent milk fat. It may be homogenized.

(b) Optional ingredients. The following safe and suitable optional ingredients may be used:

(i) Emulsifiers.

(ii) Stabilizers.

(iii) Nutritive sweeteners.

(iv) Characterizing flavoring ingredients (with or without coloring) as follows:

(a) Fruit and fruit juice (including concentrated fruit and fruit juice).

(b) Natural and artificial food flavorings.

46. HERMETICALLY SEALED CONTAINER -A "hermetically sealed container" is 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 - The term "homogenized" means that 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 4.4°C (40°F), no visible cream separation occurs in 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 percent from the fat percentage of the remaining milk as determined after thorough mixing.

48. HOOVED MAMMALS MILK - Hooved mammals milk is the normal lacteal secretion, practically free of colostrums, obtained by the complete milking of one (1) or more healthy hooved mammals. This product must be produced according to the sanitary standards of this Rule. Hooved mammals for the purpose of this Rule, include but are not limited to, the members of the Order Cetartiodactyla, such as: Family Bovidae (cattle, water buffalo, sheep, goats, yaks, etc.), Family Camelidae (llamas, alpacas, camels, etc.), Family Cervidae (deer, reindeer, moose, etc.), and Family Equidae (horses, donkeys, etc.). This product must be produced according to the sanitary standards of this Rule. (Refer to the NOTE: at the end of Section XIII )

49. ICE CREAM AND FROZEN CUSTARD -

(a) Ice Cream and Frozen Custard Specifications: These are foods produced by freezing, while stirring, a mix consisting of one or more of the optional dairy ingredients specified in paragraph (b) of this Section, and may contain one or more of the optional caseinates specified in paragraph (c) of this Section subject to the conditions hereinafter set forth, one or more of the optional hydrolyzed milk proteins as provided for in paragraph (d) of this Section subject to the conditions hereinafter set forth, and other safe and suitable nonmilk-derived ingredients; and excluding other food fats, except such as are natural components of flavoring ingredients used or are added in incidental amounts to accomplish specific functions.

(i) Ice cream is sweetened with safe and suitable sweeteners and may be characterized by the addition of flavoring ingredients. If eggs or egg yolk solids are used as an ingredient, they must be pasteurized or, if not, the mix must be pasteurized after the eggs or egg yolk solids are added.

(ii) Ice cream contains not less than 1.6 pounds of total solids to the gallon, and weighs not less than 4.5 pounds to the gallon. Ice cream contains not less than 10 percent milk fat, nor less than 10 percent nonfat milk solids, except that when it contains milk fat at 1 percent increments above the 10 percent minimum, it may contain the following milk fat-to-nonfat milk solids levels:

Percent milk fat	Minimum percent non-fat milk solids
10...................	10
11...................	9
12...................	8
13...................	7
14...................	6

Except that when one or more bulky flavors are used, the weights of milk fat and total milk solids are not less than 10 percent and 20 percent, respectively, of the remainder obtained by subtracting the weight of the bulky flavors from the weight of milk fat or total milk solids less than 8 percent and 16 percent, respectively, of the weight of the finished food. Except in the case of frozen custard, ice cream contains less than 1.4 percent egg yolk solids by weight of the food, exclusive of the weight of any bulky flavoring ingredients used.

(iii) Frozen custard must contain 1.4 percent egg yolk solids by weight of the finished food: provided, however, that when bulky flavors are added the egg yolk solids content of frozen custard may be reduced in proportion to the amount of weight of the bulky flavors added, but in no case is the content of egg yolk solids in the finished food less than 1.12 percent. A product containing egg yolk solids in excess of 1.4 percent, the maximum set forth in this paragraph for ice cream, may be marketed if labeled as specified by paragraph (e)(i) of this Section.

(iv) When calculating the minimum amount of milk fat and nonfat milk solids required in the finished food, the solids of chocolate or cocoa must be considered a bulky flavoring ingredient. In order to make allowance for additional sweetening ingredients needed when certain bulky ingredients are used, the weight of chocolate or cocoa solids, used may be multiplied by 2.5; the weight of fruit or nuts used may be multiplied by 1.4; and the weight of partially or wholly dried fruits or fruit juices may be multiplied by appropriate factors to obtain the original weights before drying and this weight may be multiplied by 1.4.

(b) Optional dairy ingredients. The optional dairy ingredients referred to in paragraph (a) of this Section are: Cream, dried cream, plastic cream (sometimes known as concentrated milk fat), butter, butter oil, milk, concentrated milk, evaporated milk, sweetened condensed milk, superheated condensed milk, dried milk, skim milk, concentrated skim milk, evaporated skim milk, condensed skim milk, superheated condensed skim milk, sweetened condensed skim milk, sweetened condensed part skim milk, nonfat dry milk, sweet cream buttermilk, condensed sweet cream buttermilk, dried sweet cream buttermilk, skim milk that has been concentrated and from which part of the lactose has been removed by crystallization, skim milk in concentrated or dried form which has been modified by treating the concentrated skim milk with calcium hydroxide and disodium phosphate, and whey and those modified whey products (e.g., reduced lactose whey, reduced minerals whey, and whey protein concentrated) that have been determined by FDA to be generally recognized as safe (GRAS) for use in this type of food. Water may be added, or water may be evaporated from the mix. The sweet cream buttermilk and the concentrated cream buttermilk or dried sweet cream buttermilk, when adjusted with water to a total solids content of 8.5 percent, has a titratable acidity of not more than 0.17 percent calculated as lactic acid. The term "milk" as used in this Section means cow's milk. Any whey and modified whey products used contribute, singly or in combination, not more than 25 percent by weight of the total nonfat milk solids content to be finished food. The modified skim milk, when adjusted with water to a total solids content of 9 percent is substantially free of lactic acid as determined by titration within 0.1N NaOH, and it has a pH value in the range of 8.0 to 8.3.

(c) Optional caseinates. The optional caseinates referred to in paragraph (a) of this Section that may be added to ice cream mix containing not less than 20 percent total milk solids are: Casein prepared by precipitation with gums, ammonium caseinate, calcium caseinate, potassium caseinate, and sodium caseinate. Caseinate may be added in liquid or dry form, but must be free of excess alkali.

(d) Optional hydrolyzed milk proteins. One or more of the optional hydrolyzed milk proteins referred to in paragraph (a) of this Section may be added as stabilizers at a level not to exceed 3 percent by weight of ice cream mix containing not less than 20 percent total milk solids provided that any whey and modified whey products used contribute, singly or in combination, not more than 25 percent by weight of the total nonfat milk solids content of the finished food. Further, when hydrolyzed milk proteins are used in the food, the declaration of these ingredients on the food label must comply with the requirements of Section XIV.

(e) Nomenclature.

(i) The name of the food is "ice cream", except that when the egg yolk solids content of the food is in excess of that specified for ice cream by paragraph (a) of this Section the name of the food is "frozen custard" or "french ice cream" or "french custard ice cream".

(ii) Flavoring Label Requirements

(a) If the food contains no artificial flavor, the name on the principal display panel or panels of the label must be accompanied by the common or usual name of the characterizing flavor, e.g., "vanilla" in letters not less than one-half the height of the letters used in the words "ice cream".

(b) If the food contains both a natural characterizing flavor and an artificial flavor simulating it, and if the natural flavor predominates, the name on the principal display panel or panels must be accompanied by the common name of the characterizing flavor, in letters not less than one-half the height of the letters used in the words "ice cream" followed by the word "flavored", in letters not less than one half the height of the letters in the name of the characterizing flavor, e.g. "vanilla flavored", or "peach flavored", or "vanilla flavored and strawberry flavored".

(c) If the food contains both a natural characterizing flavor and an artificial flavor simulating it, and if the artificial flavor predominates, or if the artificial flavor is used alone, the name on the principal display panel or panels of the label must be accompanied by the common name of the characterizing flavor in letters not less than one-half the height of the letters used in the words "ice cream", preceded by "artificial" or "artificially flavored", in letters not less than one-half the height of the letters in the name of the characterizing flavor, e.g. "artificial vanilla", "artificially flavored strawberry" or "artificially flavored vanilla and artificially flavored strawberry".

(d) If the food is subject to the requirements of paragraph (e)ii(b) of this section or if it contains any artificial flavor not simulating the characterizing flavor, the label must also bear the word "artificial flavor added" or "artificial _________ flavor added", the blank being filled in with the common name of the flavor simulated by the artificial flavor in letters of the same size and prominence as the words that precede and follow it.

(e) Whenever the name of the characterizing flavor appears on the label so conspicuously as to be easily seen under customary conditions of purchase, the words prescribed by this paragraph must immediately and conspicuously precede or follow such name, in a size reasonably related to the prominence of the name of the characterizing flavor and in any event the size of the type is not less than 6-point on packages containing at least 1 pint but less than one-half gallon, not less than 10-point on packages containing at least one-half gallon but less than 1 gallon, and not less than 12-point on packages containing 1 gallon or over: provided, however, that where the characterizing flavor and a trademark or brand are presented together, other written, printed, or graphic matter that is a part of or is associated with the trademark or brand, may intervene if the required words are in such relationship with the trademark or brand as to be clearly related to the characterizing flavor, and provided further, that if the finished product contains more than one flavor of ice cream subject to the requirements of this paragraph, the statements required by this paragraph need appear only once in each statement of characterizing flavors present in such ice cream, e.g. "Vanilla flavored, chocolate and strawberry flavored, artificial flavors added".

(iii) If the food contains both a natural characterizing flavor and an artificial flavor simulating the characterizing flavor, any reference to the natural characterizing flavor must, except as otherwise authorized by this paragraph, be accompanied by a reference to the artificial flavor, displayed with subsequently equal prominence, e.g. "strawberry and artificial strawberry flavor".

(iv) An artificial flavor simulating the characterizing flavor must be deemed to predominate:

(a) In the case of vanilla beans or vanilla extracts used in combination with vanillin if the amount of vanillin used is greater than 1 ounce per unit of vanilla constituent as defined in 21 CFR part 169 (2019).

(b) In the case of fruit or fruit juice used in combination with artificial fruit flavor, if the quantity of the fruit or fruit juice used is such that, in relation to the weight of the finished ice cream, the weight of the fruit or fruit juice, as the case may be (including water necessary to reconstitute partially or wholly dried fruits or fruit juices to their original moisture content) is less than 2 percent in the case of citrus ice cream, 6 percent in the case of berry or cherry ice cream, and 10 percent in the case of ice cream prepared with other fruits.

(c) In the case of nut meats used in combination with artificial nut flavor, if the quantity of the nut meats is such that, in relation to the finished ice cream the weight of the nut meats is less than 2 percent.

(d) In the case of two or more fruits or fruit juices, or nut meats, or both, used in combination with artificial flavors simulating the natural flavors and dispersed throughout the food, if the quantity of any fruit or fruit juice or nut meat is less than one-half the applicable percentage specified in paragraph (e)(5)(b) or (c) of this Section. For example, if a combination of ice cream contains less than 5 percent of bananas and less than 1 percent of almonds it would be "artificially flavored banana-almond ice cream". However, if it contains more than 5 percent of bananas and more than 1 percent of almonds it would be banana-almond flavored ice cream".

(v) If two or more flavors of ice cream are distinctively combined in one package, e.g., "Neapolitan" ice cream, the applicable provisions of this paragraph shall govern each flavor office cream comprising the combination.

(vi) Each of the optional ingredients used must be declared on the label as required by the applicable section of 21 CFR 101 (2019), except that sources of milk fat or milk solids not fat may be declared in descending order of predominance either by the use of the terms "milk fat and nonfat milk" when one or any combination of two or more of the ingredients listed in 21 CFR 101 (2019) are used or alternatively as permitted in 21 CFR 101 (2019). Pursuant to the FD&C (artificial colors approved by the FDA), artificial color need not be declared in ice cream except for FD&C Yellow No. 5. However, voluntary declaration of any color in ice cream is recommended.

50. Ice Cream Mix - "Ice cream mix" is the unfrozen product from which ice cream is manufactured. When applicable, the ingredient and butter fat standards must be the same for ice cream.

51. INDUSTRY PLANT SAMPLER - A person responsible for the collection of official samples for regulatory purposes at a milk plant, receiving station or transfer station as outlined in Section XIII of this Rule. This person is an employee of the milk plant, receiving station or transfer station and is evaluated at least once every two (2) year period by a State Sampling Surveillance Officer or a properly delegated Sampling Surveillance Regulatory Official.

52. LACTOSE-REDUCED MILK - "Lactose-reduced milk" is the product resulting from the treatment of milk, as defined in this rule, by the addition of safe and suitable enzymes to convert sufficient amounts of the lactose to glucose and/or galactose so that the remaining lactose is less than 30 percent of the lactose in milk.

53. LIGHT CREAM -

(a) "Light cream" is cream which contains not less than 18 percent but less than 30 percent milk fat. It may be homogenized.

(b) Optional ingredients. The following safe and suitable optional ingredients may be used:

(i) Stabilizers.

(ii) Emulsifiers.

(iii) Nutritive Sweeteners.

(iv) Characterizing flavoring ingredients (with or without coloring) as follows:

(a) Fruit and fruit juice (including concentrated fruit and fruit juice)

(b) Natural and artificial food flavorings.

54. LIGHT MILK -

(a) "Light milk" is milk that has less than or equal to 4 grams of fat per 8 ounce (240 mL) serving and contains not less than 8.25 percent milk solids not fat.

(b) Vitamin requirements.

(i) Vitamin A must be present in such quantity that each 946 milliliters (1 quart) of the food contains not less than 2,000 International Units thereof within limits of good manufacturing practice.

(ii) Addition of vitamin D is optional. If added, vitamin D must be present in such quantity that each 946 milliliters (1 quart) of the food contains 400 International Units thereof within limits of good manufacturing practice.

55. LIGHT WHIPPING CREAM, MEDIUM CREAM OR WHIPPING CREAM -

(a) "Light whipping cream, medium cream or whipping cream" is cream which contains not less than 30 percent but less than 36 percent milk fat. It may be homogenized.

(b) Optional ingredients. The following safe and suitable optional ingredients may be used:

(i) Stabilizers.

(ii) Emulsifiers.

(iii) Nutritive sweeteners.

(iv) Characterizing flavoring ingredients (with or without coloring) as follows:

(a) Fruit and fruit juice (including concentrated fruit and fruit juice).

(b) Natural and artificial food flavorings.

56. LOW-SODIUM MILK - "Low-sodium milk" is the product resulting from the treatment process of passing milk through an ion exchange resin reducing the sodium content of the product to less than 10 milligrams in 100 milliliters.

57. LOW-FAT MILK -

(a) "Low-fat milk" is milk that has between 0.5 and 3 grams of fat per 8 ounce (240 mL) serving and contains not less than 8.25 percent milk solids not fat.

(b) Vitamin requirements.

58. LOW-FAT YOGURT -

(a) "Low-fat yogurt" is the food produced by culturing one or more of the optional dairy ingredients specified in paragraph (c) of this Section with a characterizing bacterial culture that contains the lactic acid-producing bacteria, Lactobacillus bulgaricus and Streptococcus thermophilus. One or more of the other optional ingredients specified in paragraph (b) and (d) of this Section may also be added. When one or more of the ingredients specified in paragraphs (d)(i) of this Section are used, they must be included in the culturing process. All ingredients used are safe and suitable. Low-fat yogurt, before the addition of bulky flavors, contains not less than 0.5 percent nor more than 2 percent milk fat and not less than 8.25 percent milk solids not fat, and has a titratable acidity of not less than 0.9 percent, expressed as lactic acid. The food may be homogenized and may be pasteurized or ultra-pasteurized prior to the addition of the bacterial culture. Flavoring ingredients may be added after pasteurization or ultra-pasteurization. To extend the shelf life of the food, low-fat yogurt may be heat-treated after culturing is completed, to destroy viable microorganisms.

(b) Optional vitamin addition.

(ii) If added, vitamin D must be present in such quantity that each 946 milliliters (1-quart) of the food contains 400 International Units thereof, within limits of current good manufacturing practice.

(c) Optional dairy ingredients: Cream, milk, partially skimmed milk, or skim milk, used alone or in combination.

(d) Other optional ingredients.

(i) Concentrated skim milk, nonfat dry milk, buttermilk, whey, lactose, lactalbumins, lactoglobulins, or whey modified by partial or complete removal of lactose and/or minerals, to increase the nonfat solids content of the food: provided, that the ratio of protein to total nonfat solids of the food, and the protein efficiency ratio of all protein present must not be decreased as a result of adding such ingredients.

(ii) Nutritive carbohydrate sweeteners. Sugar (sucrose), beet or cane; invert sugar (in paste or syrup form); brown sugar; refiner's syrup; molasses (other than blackstrap); high fructose corn syrup; fructose; fructose syrup; maltose; maltose syrup, dried maltose syrup; malt extract, dried malt extract; malt syrup, dried malt syrup; honey; maple sugar; or any other sweetener listed in 21 CFR Part 168, except table syrup.

(iii) Flavoring ingredients.

(iv) Color additives.

(v) Stabilizers.

59. MILK -

(a) "Milk" is the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows, goats, sheep, water buffalo or other hooved mammal. Milk from cows that is in final package form for beverage use must contain not less than 8-1/4 percent milk solids not fat and not less than 3-1/4 percent milk fat. Milk may have been adjusted by separating part of the milk fat therefrom, or by adding thereto cream, concentrated milk, dry whole milk, skim milk, concentrated skim milk, or nonfat dry milk. Milk may be homogenized.

(b) Vitamin addition requirements (optional).

(i) If added, vitamin A must be present in such quantity that each 946 milliliters (1-quart) of the food contains not less than 2000 International Units thereof within limits of good manufacturing practice.

(ii) If added, vitamin D must be present in such quantity that each 946 milliliters (1-quart) of the food contains 400 International Units thereof within limits of good manufacturing practice.

(c) Optional Ingredients. The following safe and suitable ingredients may be used:

(i) Carriers for vitamin A and D.

(ii) Characterizing flavoring ingredients (with or without coloring, nutritive sweetener, emulsifiers, and stabilizers) as follows:

(a) Fruit and fruit juice (including concentrated fruit and fruit juice).

(b) Natural and artificial food flavorings.

60. MILK DISTRIBUTOR - A "milk distributor" is any person who offers for sale or sells to another any milk or milk product in its final form.

61. MILK PLANT - "Milk plant" means any place, premises or establishment where milk or milk products are collected, handled, processed, stored, pasteurized, aseptically processed, bottled or otherwise prepared for distribution and subsequent sale.

62. MILK PRODUCER -"Milk Producer" means any person who operates a dairy farm and provides, sells or offers milk for sale to a milk plant, receiving station or transfer station.

63. 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, milk, butter, evaporated milk, sweetened condensed milk, nonfat dry milk solids, half and half, sour half and half, acidified sour half and half, cultured sour half and half, concentrated milk and milk products, skim milk, reconstituted or recombined milk and milk products, low-fat milk, light milk, reduced fat milk, homogenized milk, frozen milk concentrate, eggnog, cultured milk, buttermilk, yogurt, cottage cheese, creamed cottage cheese, acidified milk, low-sodium milk, lactose-reduced milk, aseptically processed and packaged milk and milk products, milk with added safe and suitable microbial organisms, any other milk product, frozen dairy dessert or frozen dairy dessert mix, or cheese made by the addition or subtraction of milk fat or addition of safe and suitable optional ingredients for protein, vitamin or mineral fortification. Any other product must be designated as a milk product by the Commissioner.

(b) Powdered dairy blends may be labeled Grade "A" and used as ingredients in Grade "A" dairy products, such as cottage cheese dressing mixes or starter cultures used to produce various Grade "A" cultured products, if they meet the requirements of this Rule. If used as an ingredient in Grade "A" products, such as those listed above, blends of dairy powders must be blended under conditions, which meet all applicable Grade "A" requirements. Grade "A" powder blend must be made from Grade "A" powdered dairy products, except that small amounts of functional ingredients, (total of all such ingredients must not exceed 5% by weight of the finished blend) which are not Grade "A" are allowed in Grade "A" blends when the finished ingredient is not available in Grade "A" form, i.e. sodium caseinate. Dairy ingredients in small cans of freeze-dried starter culture need not be Grade "A"(FDA position)

64. MILK TANK TRUCK - A "milk tank truck" is the term used to describe both a bulk milk pickup tanker and a milk transport tank.

65. MILK TANK TRUCK CLEANING FACILITY - "Milk Tank Truck Cleaning Facility" means any place, premises, or establishment, separate from a milk plant, receiving or transfer station, where a milk tank truck is cleaned and sanitized.

66. MILK TANK TRUCK DRIVER - A "milk tank truck driver" is any person who transports raw or pasteurized milk and 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.

67. MILK TRANSPORT TANK - A "milk transport tank" is a vehicle, including the truck and tank, used by the bulk milk hauler/sampler or milk tank truck driver to transport bulk shipments of milk from a milk plant, receiving station or transfer station to another milk plant, receiving station or transfer station.

68. MILK TRANSPORTATION COMPANY - A "milk transportation company" is the company responsible for a milk tank truck(s).

69. MISBRANDED MILK AND MILK PRODUCTS - A food shall be deemed to be misbranded:

(a) If its labeling is false or misleading and does not comply with Section XIV.

(b) If it is offered for sale under the name of another food.

(c) If it is an imitation of another food, unless its label bears, in type of uniform size and prominence, the word "imitation" and, immediately thereafter, the name of the food imitated.

(d) If its container is so made, formed, or filled as to be misleading.

(e) If in package form unless it bears a label containing:

(i) The name and place of business of the manufacturer, packer, or distributor; and

(ii) An accurate statement of the quantity of the contents in terms of weight, measure, or numerical count: provided that, reasonable variations shall be permitted.

(f) If any word, statement, or other information required by or under authority of this rule to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

(g) If it purports to be or is represented as a food for which a definition and standard of identity has been prescribed, unless:

(i) Its label bears the name of the food specified in the definition and standard, and, the common names of optional ingredients (other than spices, flavoring, and coloring) present in such food.

(h) If it purports to be or is presented as a food for which a standard of quality has been prescribed by regulations as provided by Section 401 of the FD&C Act ( 21 U.S.C. section 341 (1993)), and its quality falls below such standard, unless its label bears, in such manner and form as such regulations specify, a statement that it falls below such standard; or

(i) A food for which a standard or standards of fill of container have been prescribed and falls below the standard of fill of container applicable thereto, unless the label bears a statement that the contents fall below such standard.

(i) If it is not subject to the provisions of paragraph (g) of this Section, unless its label bears:

(i) The common or usual name of the food, if any, and

(ii) In case it is fabricated from two or more ingredients, the common or usual name of each such ingredient; except that spices, flavorings, and colorings, other than those sold as such, may be designated as spices, flavorings, and colorings without naming each.

(j) If it purports to be or is represented for special dietary uses, unless its label bears such information concerning its vitamin, mineral, and other dietary properties as the Commissioner determines to be necessary in order fully to inform purchasers as to its value of such uses.

(k) If it bears or contains any artificial flavoring, artificial coloring, or chemical preservative, unless it bears labeling stating that fact. The provisions of this paragraph and paragraphs (g) and (i) with respect to artificial coloring shall not apply in the case of butter, cheese, or ice cream. The provisions of this paragraph with respect to chemical preservatives shall not apply to a pesticide chemical when used in or on a raw agricultural commodity which is the produce of the soil.

(l) If it is a raw agricultural commodity which is the produce of the soil, bearing or containing a pesticide chemical applied after harvest, unless the shipping container of such commodity bears labeling which declares the presence of such chemical in or on such commodity and the common or usual name and function of such chemical: provided, however, that no such declaration shall be required, while such commodity, having been removed from the shipping container, is being held or displayed for sale at retail out of such container in accordance with the custom of the trade.

(m) If it is a color additive, unless its packaging and labeling are in conformity with such packaging and labeling requirements, applicable to such color additive.

(n) If it contains saccharin, it is misbranded unless:

(i) Its label and labeling bear the following statement: 'USE OF THIS PRODUCT MAY BE HAZARDOUS TO YOUR HEALTH. THIS PRODUCT CONTAINS SACCHARIN WHICH HAS BEEN DETERMINED TO CAUSE CANCER IN LABORATORY ANIMALS'. Such statement must be located in a conspicuous place on such label and labeling as proximate as possible to the name of such food and must appear in conspicuous and legible type in contrast by typography, layout, and color with other printed matter on such label and labeling.

(ii) It is offered for sale, but not for immediate consumption, at a retail establishment, unless such retail establishment displays prominently, where such food is held for sale, notice (provided by the manufacturer of such food pursuant to subparagraph (ii)) for consumers respecting the information required by paragraph (n) to be on food labels and labeling.

(iii) The manufacturer of food which contains saccharin and which is offered for sale by retail establishments but not for immediate consumption took such action as may be necessary to provide such retail establishments with the notice required by subparagraph (i).

70. NCIMS- "NCIMS" means National Conference on Interstate Milk Shipments. The National Conference on Interstate Milk Shipments (NCIMS) has served as a model cooperative program between PHS/Food and Drug Administration (PHS/FDA), the States and the dairy industry and reflects the cooperative spirit of all those committed to ensuring a safe and wholesome supply of milk and milk products.

71. NONFAT YOGURT -

(a) Nonfat yogurt is the food produced by culturing one or more of the optional dairy ingredients specified in paragraph (c) of this Section with a characterizing bacterial culture that contains the lactic acid- producing bacteria, Lactobaccilus bulgaricus and Streptococcus thermophilus. One or more of the other optional ingredients specified in paragraph (b) and (c) of this Section may also be added. When one or more of the ingredients specified in paragraph (c)(i) of this Section are used, they must be included in the culturing process. All ingredients used are safe and suitable. Nonfat yogurt, before the addition of bulky flavors, contains less than 0.5 percent milk fat and not less than 8.25 percent milk solids not fat, and has a titratable acidity of not less than 0.9 percent, expressed as lactic acid. The food may be homogenized and may be pasteurized or ultra-pasteurized prior to the addition of the bacterial culture. Flavoring ingredients may be added after pasteurization or ultra- pasteurization. To extend the shelf life of the food, nonfat yogurt may be heat-treated after culturing is completed, to destroy viable microorganisms.

(b) Vitamin addition requirements (optional).

(i) If added, vitamin A must be present in such quantity that each 946 milliliters (1- quart) of the food contains not less than 2000 International Units thereof, within limits of current good manufacturing practice.

(ii) If added, vitamin D must be present in such quantity that each 946 milliliters (1-quart) of the food contains 400 International Units thereof within limits of good manufacturing practice.

(c) Optional dairy ingredients. Cream, milk, partially skimmed milk, used alone or in combination. Other optional dairy ingredients include concentrated skim milk, nonfat dry milk, buttermilk, whey, lactose, lactalbumins, lactoglobulins, or whey modified by partial or complete removal of lactose and/or minerals, to increase the nonfat solids content of the food; provided, that the ratio of protein to total nonfat solids of the food, and the protein efficiency ratio of all protein present must not be decreased as a result of adding such ingredients.

(d) Other optional ingredients:

(i) Nutritive carbohydrate sweeteners. Sugar (sucrose), beet or cane; invert sugar (in paste or syrup form); brown sugar; refiner's syrup; molasses (other than blackstrap); high fructose corn syrup; fructose; fructose syrup; maltose; maltose syrup, dried maltose syrup; malt extract, dried malt extract; malt syrup, dried malt syrup; honey; maple sugar; or any other sweeteners listed in 21 CFR Part 168, except table syrup.

(ii) Flavoring ingredients.

(iii) Color additives.

(iv) Stabilizers.

72. NOT PASTEURIZED - "Not pasteurized" means any milk or milk product that has not been subjected to the temperature and time requirements of pasteurization using equipment designed for pasteurization or has not been aseptically processed and packaged. This does not apply to cheese that has been aged at a temperature above 35°F for at least 60 days prior to sale.

73. OFFICIALLY DESIGNATED LABORATORY - An "officially designated laboratory" is a commercial laboratory authorized to do official work by the Department, or a milk industry laboratory officially designated by the Department for the examination of producer samples of Grade A raw milk for pasteurization and commingled milk tank truck samples of raw milk for drug residues and bacterial limits.

74. OFFICIAL LABORATORY - An "official laboratory" is a biological, chemical or physical laboratory which is under the direct supervision of the Department.

75. Pasteurization - The terms "pasteurization", "pasteurized" and similar terms shall mean the process of heating every particle of milk or milk product in properly designed and operated equipment, to one of the temperatures given in the following chart and held continuously at or above that temperature for at least the corresponding specified time:

(a)

Temperature	Time
*63°C (145°F)	30 minutes
*72°C (161°F)	15 seconds
*89°C (191°F)	1.0 seconds
*90°C (194°F)	0.5 seconds
*94°C (201°F)	0.1 seconds
*100°C (212°F)	0.01 seconds

* If the fat content of the milk product is 10 percent (10%) or greater, or a total solids of 18% or greater, or if it contains added sweeteners, the specified temperature must be increased by 3°C (5°F):

(b) Provided, that Eggnog must be heated to at least the following temperature and time specifications:

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

(c) 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 to be equally effective and which is approved by the Commissioner. Guidelines for properly designed and operated equipment may be found in the PMO.

76. PERSON - The word "person" includes any individual, plant operator, partnership, corporation, company, firm, trustee, association or institution.

77. PORTABLE/TEMPORARY MILKING PARLOR - A "portable/temporary milking parlor" is a mobile unit designed for occasional use.

78. RAW MILK - See Definition "Not Pasteurized".

79. RECEIVING STATION - A "receiving station" is any place, premise or establishment where raw milk is received, collected, handled, stored or cooled and prepared for further transporting.

80. RECONSTITUTED OR RECOMBINED MILK AND MILK PRODUCTS - "Reconstituted or recombined milk and/or milk products" means milk or milk products defined in this Section which result from reconstituting or recombining of milk constituents with potable water when appropriate.

81. REDUCED FAT MILK -

(a) "Reduced fat milk" is milk that has less than or equal to 6 grams of fat per 8 ounce (240 mL) serving and contains not less than 8.25 percent milk solids not fat.

(b) Vitamin addition requirements.

(i) Vitamin A must be present in such quantity that each 964 milliliters (1 quart) of the food contains not less than 2,000 International Units thereof within limits of good manufacturing practice.

82. REGULATORY AGENCY-"Regulatory Agency" means a Governmental body designated with authority to regulate milk and milk products in a given jurisdiction.

83. SANITIZATION - "Sanitization" is the application of any effective method or substance to a properly cleaned surface for the destruction of pathogens and other microorganisms. Such treatment must not adversely affect the equipment, the milk or milk product or the health of consumers, and shall be acceptable to the Department.

84. SHEEP MILK - "Sheep milk" is the normal lacteal secretion practically free of colostrum, obtained by the complete milking of one or more healthy sheep. Sheep milk and sheep milk food products must be produced according to the sanitary standards of this rule.

85. SHERBET -

(a) "Sherbet" is a food produced by freezing, while stirring, a pasteurized mix consisting of one or more of the optional dairy ingredients specified in paragraph (e) of this Section, and may contain one or more of the optional caseinates specified in paragraph (f) of this Section subject to the conditions hereinafter set forth, and other safe and suitable nonmilk-derived ingredients; and excluding other food fats, except such as are added in small amounts to accomplish specific functions or are natural components of flavoring ingredients used.

(b) Sherbet is sweetened with "SAFE AND SUITABLE SWEETENERS" and characterizing fruit ingredients specified in paragraph (g) of this Section or one or more of the non-fruit characterizing ingredients specified in paragraph (h) of this Section.

(c) Sherbet weighs not less than 6 pounds to the gallon. The milk fat content is not less than 1 percent nor more than 2 percent, the nonfat milk derived solids content not less than 1 percent, and the total milk or milk-derived solids content is not less than 2 percent nor more than 5 percent by weight of the finished food.

(d) Sherbet that is characterized by a fruit ingredient must have a titratable acidity, calculated as lactic acid, of not less than .35 percent.

(e) Optional dairy ingredients. The optional dairy ingredients referred to in paragraph (a) of this Section are:

Cream, dried cream, plastic cream (sometimes known as concentrated milk fat), butter, butter oil, milk, concentrated milk, evaporated milk, superheated condensed milk, sweetened condensed milk, dried milk, skim milk, concentrated skim milk, evaporated skim milk, condensed skim milk, sweetened condensed skim milk, sweetened condensed part-skim milk, nonfat dry milk, sweet cream buttermilk, condensed sweet cream buttermilk, dried sweet cream buttermilk, skim milk that has been concentrated and from which part of the lactose has been removed by crystallization, and whey and those modified whey products (e.g., reduced lactose whey, reduced minerals whey, and whey protein concentrate) that comply with 21 CFR Part 184. Water may be added, or water may be evaporated from the mix. The sweet cream buttermilk and the concentrated sweet cream buttermilk or dried sweet cream buttermilk, when adjusted with water to a total solids content of 8.5 percent, has a titratable acidity of not more than 0.17 percent, calculated as lactic acid. The term "milk" as used in this section means cow's milk.

(f) Optional caseinates. The optional caseinates referred to in paragraph (a) of this Section which may be added to sherbet mix are:

Casein prepared by precipitation with gums, ammonium caseinate, calcium caseinate, potassium caseinate, and sodium caseinate. Caseinates may be added in liquid or dry form, but must be free of excess alkali; such caseinates are not considered to be milk solids.

(g) Optional fruit-characterizing ingredients. The optional fruit characterizing ingredients referred to in paragraph (b) of this Section are any mature fruit or the juice of any mature fruit. The fruit or fruit juice used may be fresh, frozen, canned, concentrated, or partially or wholly dried. The fruit may be thickened with pectin or other optional ingredients. The fruit is prepared by the removal of pits, seeds, skins, and cores, where such removal is usual in preparing that kind of fruit for consumption as fresh fruit. The fruit may be screened, crushed, or otherwise comminuted. It may be acidulated. In the case of concentrated fruit or fruit juices, from which part of the water is removed, substances contributing flavor volatilized during water removal may be condensed and reincorporated in the concentrated fruit or fruit juice. In the case of citrus fruits, the whole fruit, including the peel but excluding the seeds, may be used, and in the case of citrus juice or concentrated citrus juices, cold-pressed citrus oil may be added thereto in an amount not exceeding that which would be obtained if the whole fruit had been used. The quantity of fruit ingredients used is such that, in relation to the weight of the finished sherbet, the weight of fruit or fruit juice, as the case may be (including water necessary to reconstitute partially or wholly dried fruits or fruit juices to their original moisture content), is not less than 2 percent in the case of citrus sherbets, 6 percent in the case of berry sherbets, and 10 percent in the case of sherbets prepared with other fruits. For the purpose of this Section, tomatoes and rhubarb are considered as kinds of fruit.

(h) Optional non-fruit characterizing ingredients. The optional non-fruit characterizing ingredients referred to in paragraph (b) of this Section include but are not limited to the following:

(i) Ground spice or infusion of coffee or tea.

(ii) Chocolate or cocoa, including syrup.

(iii) Confectionery.

(iv) Distilled alcoholic beverage, including liqueurs or wine, in an amount not to exceed that required for flavoring the sherbet.

(v) Any natural or artificial food flavoring (except any having a characteristic fruit or fruit-like flavor).

(i) Nomenclature.

(i) The name of each sherbet is as follows:

(a) The name of each fruit sherbet is "__________ sherbet", the blank being filled in with the common name of the fruit or fruits from which the fruit ingredients used are obtained. When the names of two or more fruits are included, such names must be arranged in order of predominance, if any, by weight of the respective fruit ingredients used.

(b) The name of each non-fruit sherbet is "_________ sherbet", the blank being filled in with the common or usual name or names of the characterizing flavor or flavors; for example, "peppermint", except that if the characterizing flavor used is vanilla, the name of the food is "sherbet", the blank being filled in as specified by 21 CFR 135.110(e) (2) and (5) (i) (2019).

(ii) Artificial flavoring or artificial coloring - When the optional ingredients, artificial flavoring, or artificial coloring are used in sherbet, they must be named on the label as follows:

(a) If the flavoring ingredient or ingredients consists exclusively of artificial flavoring, the label designation must be "artificially flavored".

(b) If the flavoring ingredients are a combination of natural and artificial flavors, the label designation must be "artificial and natural flavoring added".

(c) The label must designate artificial coloring by the statement "artificially colored", "artificial coloring added", "with added artificial coloring", or "___________, and artificial color added", the blank being filled in with the name of the artificial coloring used.

(j) Characterizing flavor(s). Wherever there appears on the label any representation as to the characterizing flavor or flavors of the food and such flavor or flavors consist in whole or in part of artificial flavoring, the statement required in paragraph (i) (ii)(a) and (b) of this Section, as appropriate, must immediately and conspicuously precede or follow such representation, without intervening written, printed, or graphic matter (except that the word "sherbet" may intervene) in a size reasonably related to the prominence of the name of the characterizing flavor and in any event the size of the type is not less than 6-point on packages containing less than 1 pint, not less than 8-point on packages containing at least 1 pint but less than one-half gallon, not less than 10 point on packages containing at least one-half gallon but less than 1 gallon, and not less than 12 point on packages containing 1 gallon or over.

(k) Display of statements required in paragraph (i)(ii). Except as specified in paragraph (j) of this Section, the statements required by paragraph (i)(ii) of this Section must be set forth on the principal display panel or panels of the label with such prominence and conspicuousness as to render them likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

(l) Label declarations. Each of the optional ingredients used must be declared on the label, as required in Section XIV.

86. SKIM, FAT-FREE, NONFAT MILK -

(a) "Skim, fat-free, nonfat milk" is milk that has less than 0.5 grams of fat per 8 ounce (240mL) serving and contains not less than 8.25 percent milk solids not fat.

(b) Vitamin addition requirements.

87. SOUR CREAM OR CULTURED SOUR CREAM -

(a) "Sour cream" results from the souring, by lactic acid producing bacteria, of cream. Sour cream contains not less than 18 percent milk fat; except that when the food is characterized by the addition of nutritive sweeteners or bulky flavoring ingredients, the weight of the milk fat is not less than 18 percent of the remainder obtained by subtracting the weight of such optional ingredients from the weight of the food; but in no case does the food contain less than 14.4 percent milk fat. Sour cream has a titratable acidity of not less than 0.5 percent, calculated as lactic acid.

(b) Optional ingredients.

(i) Safe and suitable ingredients that improve texture, prevent syneresis, or extend the shelf life of the product.

(ii) Sodium citrate in an amount not more than 0.1 percent may be added prior to culturing as a flavor precursor.

(iii) Rennet.

(iv) Safe and suitable nutritive sweeteners.

(v) Salt.

(vi) Flavoring ingredients, with or without safe and suitable coloring, as follows:

(a) Fruit and fruit juice (including concentrated fruit and fruit juice).

(b) Safe and suitable natural and artificial food flavoring.

88. SOUR HALF-AND-HALF OR CULTURED SOUR HALF-AND-HALF -

(a) "Sour half-and-half" results from the souring, by lactic acid producing bacteria, of pasteurized half-and-half. Sour half-and-half contains not less than 10.5 percent but less than 18 percent milk fat; except that when the food is characterized by the addition of nutritive sweeteners or bulky flavoring ingredients, the weight of the milk fat is not less than 10.5 percent of the remainder obtained by subtracting the weight of such optional ingredients from the weight of the food; but in no case does the food contain less than 8.4 percent milk fat. Sour half-and-half has a titratable acidity of not less than 0.5 percent, calculated as lactic acid.

(b) Optional ingredients.

(i) Safe and suitable ingredients that improve texture, prevent syneresis, or extend the shelf life of the product.

(ii) Sodium citrate in an amount not more than 0.1 percent may be added prior to culturing as a flavor precursor.

(iii) Rennet.

(iv) Safe and suitable nutritive sweeteners.

(v) Salt.

(vi) Flavoring ingredients, with or without safe and suitable coloring, as follows:

(a) Fruit and fruit juice (including concentrated fruit and fruit juice).

(b) Safe and suitable natural and artificial food flavoring.

(vii) Safe and suitable coloring.

89. STERILIZED - The term "sterilized" when applied to piping, equipment and containers used for milk and milk products means the condition achieved by the application of heat, chemical sterilant(s) or other appropriate treatment that renders the piping, equipment and containers free of viable microorganisms.

90. TIME/TEMPERATURE CONTROL FOR SAFETY OF MILK AND MILK PRODUCTS-Milk and milk products that require time/temperature control for safety (TCS) to limit pathogenic microorganism growth or toxin formation includes:

(a) Milk or milk products that are raw, heat-treated, pasteurized, or ultra-pasteurized; or

(b) Except as specified in c. below of this definition, a milk or milk product that because of the interaction of its a_w and pH values is designated as Product Assessment (PA) as required in either Table A or B as follows:

Table A. Interaction of pH and a_w for Control of Spores in Milk and Milk Products Pasteurized to Destroy Pathogenic Vegetative Cells and Subsequently Packaged*
A_w values	pH values
4.6 or less	>4.6 - 5.6	>5.6
0.92 or less	Non-TCS**	Non-TCS	Non-TCS
> 0.92 - 0.95	Non-TCS	Non-TCS	PA***
> 0.95	Non-TCS	PA	PA

*Refer to Appendix R in the PMO for instruction on how to use Table A.

** TCS means TIME/TEMPERATURE CONTROL FOR SAFETY MILK AND MILK PRODUCTS.*** PA means either that the product needs time and temperature control or further PRODUCT ASSESSMENT is required to determine if the milk or milk product is Non-TCS.

Table B. Interaction of pH and A_w for Control of Pathogenic Vegetative Cells and Spores in Milk and Milk Products not Pasteurized or Pasteurized but not Packaged*
A_w values	pH values
<4.2	4.2 - 4.6	>4.6 - 5.0	>5.0
<0.88	Non-TCS	Non-TCS	Non-TCS	Non-TCS
0.88 - 0.90	Non-TCS	Non-TCS	Non-TCS	PA
>0.90 - 0.92	Non-TCS	Non-TCS	PA	PA
> 0.92	Non-TCS	PA	PA	PA

* Refer to Appendix R in PMO for instruction on how to use Table B.

(c) This definition does not include:

(i) A milk or milk product that because of its pH or a_w value, or interaction of a_w and pH values, is designated as Non-TCS in Table A or B as specified in 2. above of this definition;

(ii) A milk or milk product, in an unopened hermetically sealed container, that is commercially processed to achieve and maintain commercial sterility under conditions of non-refrigerated storage and distribution;

(iii) A milk or milk product for which evidence (acceptable to FDA) demonstrates that time/temperature control for safety is not required as specified under this definition (such as, a product containing a preservative known to inhibit pathogenic microorganisms, or other barriers to the growth of pathogenic microorganisms, or a combination of barriers that inhibit the growth of pathogenic microorganisms); or

(iv) A milk or milk product that does not support the growth of pathogenic microorganisms as specified under this definition even though the milk or milk product may contain a pathogenic microorganism or chemical or physical contaminant at a level sufficient to cause illness or injury.

91. TRANSFER STATION - A "transfer station" is any place, premises or establishment where milk or milk products are transferred directly from one milk tank truck to another.

92. ULTRA-PASTEURIZATION - The term "ultra-pasteurization", when used to describe a dairy product, means that such product must have been thermally processed at or above 138°C (280°F) for at least two (2) seconds, either before or after packaging, so as to produce a product that has an extended shelf life under refrigerated conditions.

93. WATER BUFFALO MILK-"Water buffalo milk" is the normal lacteal secretion, practically free of colostrum, obtained by the complete milking of one (1) or more healthy water buffalo. Water buffalo milk must be produced according to the sanitary standards of this Rule. The word "milk" shall be interpreted to include water buffalo milk.

94. WHIPPED CREAM - "Whipped cream" is heavy cream or light whipping cream into which air or inert gas has been incorporated.

95. WHIPPED LIGHT CREAM - "Whipped light cream" is light cream into which air or inert gas has been incorporated.

96. YOGURT -

(a) "Yogurt" is the food produced by culturing one or more of the optional dairy ingredients specified in paragraph (c) of this Section with a characterizing bacterial culture that contains the lactic acid-producing bacteria Lactobacillus bulgaricus and Streptococcus thermophilus. One or more of the other optional ingredients specified in paragraph (b) and (d) of this Section may also be added. When one or more of the ingredients specified in paragraph (d)(i) of this Section are used, they must be included in the culturing process. All ingredients used are safe and suitable. Yogurt, before the addition of bulky flavors, contains not less than 3.25 percent milk fat and not less than 8.25 percent milk solids not fat, and has a titratable acidity of not less than 0.9 percent, expressed as lactic acid. The food may be homogenized and may be pasteurized or ultra-pasteurized prior to the addition of the bacterial culture. Flavoring ingredients may be added after pasteurization or ultra- pasteurization. To extend the shelf life of the food, yogurt may be heat treated after culturing is completed, to destroy viable microorganisms.

(b) Vitamin Requirements (optional).

(c) Optional dairy ingredients: Cream, milk, partially skimmed milk, or skim milk, used alone or in combination.

(d) Other optional ingredients.

(i) Concentrated skim milk, nonfat dry milk, buttermilk, whey, lactose, lactalbumins, lactoglobulins, or whey modified by partial or complete removal of lactose and/or minerals, to increase the nonfat solids content of the food: provided that the ratio of protein to total nonfat solids of the food and the protein efficiency ratio of all protein present must not be decreased as a result of adding such ingredients.

(ii) Nutritive carbohydrate sweeteners. Sugar (sucrose), beet or cane; invert sugar (in paste or syrup form); brown sugar; refiner's syrup; molasses (other than blackstrap); high fructose corn syrup; fructose; fructose syrup; maltose; maltose syrup, dried maltose syrup; malt extract, dried malt extract; malt syrup, dried malt syrup; honey; maple sugar; or any other sweeteners listed in 21 CFR Part 168, except table syrup.

(iii) Flavoring ingredients.

(iv) Color additives.

(v) Stabilizers.

01-001 C.M.R. ch. 329, § I