Section 345IAC8-2-1.7. "Pasteurization", "pasteurized", "ultra pasteurization", and "aseptic processing" defined

  7. (a) As used in this article, "pasteurization" or "pasteurized" means the process of heating every particle of milk or milk product in a manner that meets all of the following requirements:

(1) The equipment is approved by the board.

(2) The equipment is properly designed and operated. Proper design and operation of the equipment under IC 15-17-2-82 and this article means design and operation according to the requirements in this section and the requirements in Section 7 Items 16p, 16p(A) through 16p(E) and Appendix H in the PMO incorporated by reference in 345 IAC 8-3-1.

(3) Each particle of milk or milk product must be heated to a temperature designated in the tables in subsection (b) and held continuously at or above that temperature for at least the time that corresponds with the temperature in the tables in subsection (b) using the type of equipment specified in the tables in subsection (b).

  (b) Each of the following time and temperature requirement options is subordinate to the operating requirements prescribed in subsection (a)(2). If an operating requirement prescribes a time, temperature, and equipment combination that is different than the following table, the specific operating requirement is required:

(1) Table 1 as follows:

Temperature	Equipment	Time
63 degrees Celsius (145 degrees Fahrenheit)	vat pasteurizer	30 minutes
72 degrees Celsius (161 degrees Fahrenheit)	continuous flow pasteurizer	15 seconds

However, if the fat content of the milk product is ten percent (10%) or greater, the total solids content of the milk product is eighteen percent (18%) or greater, or if the milk product contains added sweeteners, the specified temperature in Table 1 shall be increased by three (3) degrees Celsius (five (5) degrees Fahrenheit).

(2) Table 2 as follows:

Temperature	Equipment	Time
89 degrees Celsius (191 degrees Fahrenheit)	continuous flow pasteurizer	1 second
90 degrees Celsius (194 degrees Fahrenheit)	continuous flow pasteurizer	0.5 second
94 degrees Celsius (201 degrees Fahrenheit)	continuous flow pasteurizer	.1 second
96 degrees Celsius (204 degrees Fahrenheit)	continuous flow pasteurizer	.05 second
100 degrees Celsius (212 degrees Fahrenheit)	continuous flow pasteurizer	.01 second

(3) Notwithstanding Tables 1 and 2, eggnog shall be heated to at least the following temperature and time specifications:

Temperature	Equipment	Time
69 degrees Celsius (155 degrees Fahrenheit)	vat pasteurizer	30 minutes
80 degrees Celsius (175 degrees Fahrenheit)	continuous flow pasteurizer	25 seconds
83 degrees Celsius (180 degrees Fahrenheit)	continuous flow pasteurizer	15 seconds

  (c) A pasteurization process that is different than those described in subsection (a) may be used if the following requirements are met:

(1) The process has been officially recognized by the United States Food and Drug Administration to be equally effective.

(2) The state veterinarian approves the procedure as being equally effective.

  (d) As used in this article, "ultra pasteurized" means dairy products that have been thermally processed at or above two hundred eighty (280) degrees Fahrenheit (one hundred thirty-eight (138) degrees Celsius) for at least two (2) seconds, either before or after packaging, so as to extend the shelf life of the product under refrigerated conditions.

  (e) As used in this article, "aseptic processing" and "aseptic processing and packaging" means the heat processing and filling of a milk or milk product into presterilized containers, followed by hermetical sealing with a presterilized closure, in an atmosphere free of microorganisms. Aseptic processing and packaging shall be performed in accordance with the requirements of 21 CFR Parts 108, 110, and 113 to maintain commercial sterility of the product under normal nonrefrigerated conditions.

  (f) As used in this article, "aseptic processing and packaging system" and "APPS" means the aseptic processing and packaging system in a milk plant is comprised of the processes and equipment used to process and package aseptic Grade A milk or milk products. The APPS shall be constructed and operated in accordance with the applicable requirements in 21 CFR Parts 108, 110, and 113. The APPS shall begin at the constant level tank and end at the discharge of the packaging machine, provided that the process authority may provide written documentation that clearly defines additional processes or equipment that are considered critical to the commercial sterility of the product.

  (g) As used in this article, "low-acid aseptic milk and milk products" means milk or milk products having a water activity (a_w) greater than 0.85 and a finished equilibrium pH greater than 4.6 and are regulated under 21 CFR Parts 108, 110, and 113. Aseptically processed and packaged low-acid milk and milk products are stored under normal nonrefrigerated conditions. This term does not include low-acid milk and milk products that are labeled for storage under refrigerated conditions. (Indiana State Board of Animal Health; 345 IAC 8-2-1.7; 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; filed Sep 11, 2012, 2:35 p.m.: 20121010-IR-345120107FRA)