Section 345 IAC 8-2-2.1 - Manufacturing grade milk plant; construction; operation; sanitationAuthority: IC 15-17-3-21
Affected: IC 15-18-1-9
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 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:(1) Section 1. Definitions.(2) Section 4. Labeling. However, requirements in this Section that specifically apply to the labeling of Grade A milk products are not incorporated.(3) Item 1p. Floors - Construction.(4) Item 2p. Walls and Ceilings - Construction.(5) Item 3p. Doors and Windows.(6) Item 4p. Lighting and Ventilation.(7) Item 5p. Separate Rooms.(8) Item 6p. Toilet-Sewage Disposal Facilities.(9) Item 7p. Water Supply.(10) Item 8p. Handwashing Facilities.(11) Item 9p. Milk Plant Cleanliness.(12) Item 10p. Sanitary Piping.(13) Item 11p. Construction and Repair of Containers and Equipment. However, requirements in the Section that specifically apply to the containers and equipment for Grade A milk products are not incorporated.(14) Item 12p. Cleaning and Sanitizing of Containers and Equipment.(15) Item 13p. Storage of Cleaned Containers and Equipment.(16) Item 14p. Storage of Single-Service Articles, Utensils, and Materials.(17) Item 15p. Protection from Contamination.(18) Item 16p. Pasteurization, including the procedures for the following: (A) Batch pasteurization.(B) High-temperature-short-time (HTST) continuous flow pasteurization.(C) Pasteurizers employing regenerative heating.(D) Pasteurization records, equipment tests, and examinations. However, this Item does not apply to raw milk cheeses.(19) Item 17p. Cooling of Milk and/or Milk Products. However, this Item does not apply to the following products:(B) Raw milk cheeses during the sixty (60) day aging process.(C) Manufacturing grade raw milk received for processing and governed by the temperature and storage requirements set forth at IC 15-18-1-19.(20) Item 18p. Bottling, Packaging and Container Filling must occur:(A) at the place of pasteurization in a sanitary manner; and(B) in accordance with the standards for mechanical equipment set forth in this Item. However, if the plant does not use approved mechanical equipment, then the requirements in clause (B) do not apply.(21) Item 19p. Capping, Container Closure, and Sealing and Dry Milk Product Storage must occur: (A) at the place of pasteurization in a sanitary manner; and(B) in accordance with the standards for mechanical equipment set forth in this Item. However, if the plant does not use approved mechanical equipment, then the requirements of clause (B) do not apply.(22) Item 20p. Personnel - Cleanliness and Practices.(24) Item 22p. Surroundings.(25) Appendix D. Standards for Water Sources.(26) Appendix F. Cleaning and Sanitization.(27) Appendix G. Chemical and Bacteriological Tests.(28) Appendix H. Pasteurization Equipment and Procedures and Other Equipment.(29) Appendix I. Pasteurization Equipment and Controls - Tests.(30) Appendix L. Applicable Regulations, Standards of Identity for Milk and Milk Products.(31) Appendix N. Drug Residue Testing and Farm Surveillance.(32) Appendix R. Determination of Time/Temperature Control for Safety Milk and/or Milk Products.(33) Appendix S. Aseptic Processing and Packaging Program and Retort Processed after Packaging Program.(c) A manufacturing grade milk plant must follow and the board incorporates by reference the following Subparts of 21 CFR 117 as a rule of the board: (1) Subpart A - General Provisions. However, the following provisions are not incorporated: (A)21 CFR 117.5(b) through 21 CFR 117.5(j).(2) Subpart B - Good Manufacturing Practices.(3) Subpart C - Hazard Analysis and Risk Based Preventive Controls.(4) Subpart D - Modified Requirements, except 21 CFR 117.201 is not incorporated.(5) Subpart F - Requirements Applying to Records that must be Established and Maintained. However, the following provisions are not incorporated:(6) Subpart G - Supply Chain Program.(d) Milk received for pasteurization, processing, or packaging by a manufacturing grade milk plant must be obtained from one (1) of the following sources: (1) A dairy farm within the state that holds a valid Grade A or manufacturing grade permit issued under this article.(2) A dairy farm outside the state that holds a valid Grade A or manufacturing grade permit in the state of origin.(3) Any other source of milk that has been approved by the state veterinarian based upon a finding that the source meets the standards of this article.(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 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 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 considered satisfactory when the results of not more than one (1) of four (4) consecutive samples taken upon separate days exceed ten (10) per gram.Indiana State Board of Animal Health; 345 IAC 8-2-2.1; filed 12/7/2016, 9:26 a.m.: 20170104-IR-345160222FRAFiled 6/13/2018, 2:27 p.m.: 20180711-IR-345170566FRA, eff 9/17/2018Filed 2/23/2021, 1:10 p.m.: 20210324-IR-345200476FRAThis version of section effective September 17, 2018. See also preceding version of section, effective until September 17, 2018.