Section 345IAC8-2-1.5. "Grade A milk and milk products" defined

  5. (a) As used in this article, "Grade A milk and milk products" means the following:

(1) All milk and milk products with a standard of identity provided for in 21 CFR Part 131, excluding 21 CFR Part 131.120 sweetened condensed milk.

(2) Cottage cheese (21 CFR Part 133.128) and dry curd cottage cheese (21 CFR Part 131.129) when it is produced under the provisions in 345 IAC 8-3-1.

(3) Whey and whey products as defined in 21 CFR 184.1979, 21 CFR 184.1979a, 21 CFR 184.1979b, 21 CFR 184.1979c, and section 1.8 of this rule.

(4) Modified versions of the foods listed in subdivisions (1) through (3) pursuant to 21 CFR Part 130.10.

(5) Milk and milk products as defined in subdivisions (1) through (4) that are packaged in combination with foods not included in this definition that are appropriately labeled with a statement of identity to describe the foods in final packaged form, for example, "cottage cheese with pineapple" and "fat free milk with plant sterols".

(6) Products not included in subdivisions (1) through (5) are milk products if the product has:

(A) a minimum of two percent (2.0%) milk protein (total Kjeldahl nitrogen (TKN) × 6.38); and

(B) a minimum of sixty-five percent (65%) by weight milk, milk products, or a combination of milk products.

  (b) Dairy ingredients that are not Grade A dairy ingredients under this article may be utilized in products defined in subsection (a) for a functional or technical effect if they meet all of the following:

(1) The ingredients are safe and suitable as defined in 21 CFR 130.3(d). However, the use of a non-Grade A dairy ingredient to increase weight or volume of a product or to displace grade A dairy ingredients is not a suitable functional or technical effect.

(2) The ingredients and their use are consistent with good manufacturing practices as defined in 21 CFR Part 110.

(3) The ingredients are at least one (1) of the following:

(A) Prior sanctioned under 21 CFR Part 181 or otherwise approved by the United States Food and Drug Administration.

(B) Generally recognized as safe under 21 CFR Part 182 or 21 CFR Part 184.

(C) An approved food additive under 21 CFR Part 172 or 21 CFR Part 173.

  (c) Milk and milk products include those milk and milk products that have been aseptically processed and then packaged.

  (d) The following are not included in the definition of milk and milk products:

(1) A milk or milk product in which the milkfat of the milk or milk product has been substituted in part or in whole by any other animal or vegetable fat. Provided, however, that other fat sources may be included when they are legally used for purposes currently accepted in other products that are lawfully added to Grade A milk or milk products, such as carriers for vitamins and as an ingredient in emulsifiers and stabilizers.

(2) Coffee based products where coffee or water is the primary ingredient, as indicated in the ingredient statement for the product in compliance with 21 CFR Part 101.

(3) Tea based products where tea or water is the primary ingredient, as indicated in the ingredient statement for the product in compliance with 21 CFR Part 101.

(4) Dietary supplements that are not otherwise defined or included in the definition in this section.

(5) Infant formula produced under 21 CFR Part 106 and 21 CFR Part 107.

(6) Ice cream and other frozen desserts.

(7) Butter.

(8) Cheese, including standardized cheese but not including cottage cheese (21 CFR Part 133.128) and dry curd cottage cheese (21 CFR Part 131.129) and nonstandardized cheese.

(9) Puddings.

  (e) Milk and milk products that have been retort processed after packaging or that have been concentrated, condensed, or dried are only included in definition of Grade A milk and milk products if they are used as an ingredient to produce any milk or milk product defined in subsection (a) or if they are labeled as Grade A. Powdered dairy blends may be labeled Grade A and used as ingredients in Grade A milk and milk products if they meet the requirements of this article, such as cottage cheese dressing mixes or starter media for cultures used to produce various Grade A cultured milk and milk products.

  (f) Blends of dairy powders that are used as ingredients in Grade A milk and milk products must be blended under conditions that meet all applicable Grade requirements in this article. Grade A powder blends must be made from Grade A powdered milk and milk products. However, small amounts of functional ingredients that are not Grade A may be used in Grade A blends when the:

(1) total use of such ingredients does not exceed ten percent (10%) of the weight of the finished blend; and

(2) finished ingredient is not available in Grade A form (such as sodium caseinate).

(Indiana State Board of Animal Health; 345 IAC 8-2-1.5; filed Sep 27, 2002, 2:40 p.m.: 26 IR 331; filed Jul 18, 2005, 1:00 p.m.: 28 IR 3560; readopted filed May 9, 2007, 3:16 p.m.: 20070516-IR-345070037RFA; filed Dec 10, 2010, 10:42 a.m.: 20110105-IR-345100123FRA)