in-20250910-IR-345250151FRA: DIGEST DAIRY PRODUCTS INSPECTION; INCORPORATIONS BY REFERENCE

Final Rule LSA Document #25-151 DIGEST Sec. 2.1. (a) Except as provided in section 2.2 of this rule, a manufacturing grade milk plant shall meet the requirements in this section. (b) The board incorporates by reference as a rule of the board the following parts of the Grade A Pasteurized Milk Ordinance, United States Department of Health and Human Services, Public Health Service, Food and Drug Administration (2019 (2023 revision), referred to as the PMO for regulation of the production, transportation, processing, handling, sampling, examination, grading, labeling, and sale of all manufacturing grade milk products in the state: (c) A manufacturing grade milk plant must shall follow, and the board incorporates by reference, the following Subparts of 21 CFR 117 as a rule of the board: (d) Milk received for pasteurization, processing, or packaging by a manufacturing grade milk plant must be obtained from one (1) of the following sources: (e) Where matters incorporated by reference in this section conflict with provisions of this article, IC 15-17-2, or IC 15-18-1, the express provisions of this article and the Indiana Code shall control. (f) Frozen desserts in the manufacturer's unbroken package shall must have a bacterial plate count of not more than thirty thousand (30,000) per gram and a coliform count of not more than ten (10) per gram. The bacterial plate count shall be is considered satisfactory when the results of not more than two (2) of the last four (4) consecutive samples taken on separate days exceed thirty thousand (30,000) per gram. The coliform count shall be is considered satisfactory when the results of not more than one (1) of four (4) consecutive samples taken upon on separate days exceed ten (10) per gram. Sec. 1. (a) The board incorporates by reference as a rule of the board the Grade A Pasteurized Milk Ordinance, United States Department of Health and Human Services, Public Health Service, Food and Drug Administration (2019 (2023 revision), referred to as the PMO for regulation of the production, transportation, processing, handling, sampling, examination, grading, labeling, and sale of all Grade A milk and milk products in the state. Except where specifically excluded, the board intends to incorporate all parts of the PMO to include all of the administrative procedures and the appendixes. However, the following parts of the PMO are not incorporated by reference as a rule of the board: (b) The board will utilize use the latest edition of the following documents when interpreting and implementing the provisions of the PMO, this article, and IC 15-18: (c) The board adopts by reference the general provisions relating to food standards set forth by the United States Food and Drug Administration in 21 CFR 130.8, 21 CFR 130.9, 21 CFR 130.10, and 21 CFR 130.11, in effect on April 1, 2020 2024. (d) The board adopts by reference the definitions and standards of identity for milk and milk products set forth by the United States Food and Drug Administration in 21 CFR 131.3 et seq., titled "Part 131–Milk and Cream", in effect on April 1, 2020 2024. Milk and milk products must conform to these standards. (e) The board adopts by reference the definitions and standards of identity for cheeses and related cheese products set forth by the United States Food and Drug Administration in 21 CFR 133.3 et seq., titled "Part 133–Cheeses and Related Cheese Products", in effect on April 1, 2020 2024. Cheese and cheese products must conform to these standards. (f) The board adopts by reference the definitions and standards of identity for frozen desserts set forth by the United States Food and Drug Administration in 21 CFR 135.3 et seq., titled "Part 135-Frozen Desserts", in effect on April 1, 2020 2024. Frozen desserts must conform to these standards. (g) The board adopts by reference the current good manufacturing practices for manufacturing, packing, or holding human food set forth by the United States Food and Drug Administration in 21 CFR 113, in effect on April 1, 2020 2024. The criteria and definitions in 21 CFR 113 and this rule shall apply in determining whether a food is adulterated under IC 15-18-1, in that because the food has been manufactured under such those conditions, that it is: (h) The board adopts by reference as a rule of the board the food labeling requirements set forth by the United States Food and Drug Administration in 21 CFR 101, but not including Subpart C, in effect on April 1, 2020 2024. (i) The board incorporates by reference into this rule the definitions set forth in IC 15-17-2 and the matters set forth in IC 15-18-1. (j) Where the matters incorporated by reference in this section conflict with provisions of this article, IC 15-17-2, or IC 15-18-1, the express provisions of this article and the Indiana Code shall control. (k) Incorporated documents are available for public inspection at the Indiana State Board of Animal Health. Copies of incorporated documents, and interpreting and implementing documents, may be obtained from the Food and Drug Administration, Milk Safety Branch website https://www.fda.gov/food, the U.S. Government Publishing Office website https://www.gpo.gov/, or by sending a written request to the board https://www.in.gov/boah/contact-boah/.