TITLE 345 INDIANA STATE BOARD OF ANIMAL HEALTH

Amends 345 IAC 8-2-1.7, 345 IAC 8-2-4, 345 IAC 8-2-5, 345 IAC 8-3-1, 345 IAC 8-3-2, and 345 IAC 8-3-10 to incorporate the 2011 edition of the Pasteurized Milk Ordinance and update other matters incorporated by reference and to make other changes in the law governing milk and milk products. Effective 30 days after filing with the Publisher.

SECTION 1. 345 IAC 8-2-1.7 IS AMENDED TO READ AS FOLLOWS:

Affected: IC 15-17-2-82; IC 15-18-1

Sec. 1.7. (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:

(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:

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

(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 commercially sterilized cooled 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 and Section 7, Items 16p and 16p(C) and Appendix H in the Pasteurized Milk Ordinance incorporated by reference in 345 IAC 8-3 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.

SECTION 2. 345 IAC 8-2-4 IS AMENDED TO READ AS FOLLOWS:

Affected: IC 15-18-1-12

Sec. 4. (a) Every bulk milk pickup tanker used to collect raw milk on a bulk milk route shall be of sanitary design and construction. The owner of a tank truck shall be responsible for maintaining it and its milk contact equipment in good repair. The bulk milk pickup tanker owner is responsible for making certain cleaning and sanitizing the truck and equipment have been cleaned and sanitized at least once every twenty-four (24) hours regularly in a manner and at a location approved by the board. A cleaning and sanitizing tag approved by the board shall be completed and affixed in the rear compartment of the bulk milk pickup tanker each day after cleaning and sanitizing. The bulk milk pickup tanker and its milk contact equipment shall be protected from contamination after being cleaned and sanitized.

(b) Milk in a bulk milk pickup tanker shall be maintained at a temperature of forty-five (45) degrees Fahrenheit or less from the time of collection until delivered to a milk plant, receiving station, or transfer station. If the milk being delivered is manufacturing grade raw milk, the raw milk shall be maintained at a temperature of sixty (60) degrees Fahrenheit or less from the time of collection until delivered to a manufacturing grade milk plant, receiving station, or transfer station.

(c) Tank trucks used to transport milk shall not be used to transport other products unless they have been thoroughly washed and sanitized after having been used to transport such other products. Only products fit for human consumption are authorized to be stored or transported in tank trucks used to transport milk or milk products.

(d) The name and address of the owner of a bulk milk pickup tanker shall be legibly marked on both sides or on the rear of the vehicle. The name of the owner shall be in letters not less than three (3) inches in height provided that markings in use before March 1, 1998, may be the same height as the address, and the address shall be in letters not less than one and one-half (1 1/2) inches in height.

(e) Every bulk milk pickup tanker used to collect raw milk on a bulk milk route shall be equipped with the following:

(f) Each milk hauler shall be equipped with an accurate pocket-type thermometer with an unbreakable stem when collecting milk from dairy farms and shall observe the following sanitary practices in collecting milk:

(g) Every time a milk hauler collects milk from a dairy farm, he or she shall collect a sample of milk from each farm bulk tank and silo after the milk has been thoroughly agitated and before opening the outlet valve. Samples may be collected from a properly installed and operated in-line-sampler or aseptic sampler that is approved by the board to collect representative samples. The sample shall be collected in the following manner:

(h) Bulk milk tank raw milk shall be collected within the following time frames:

(i) It shall be the responsibility of the milk plant, receiving station, or transfer station to:

(j) Any truck transporting raw, heat-treated, or pasteurized milk and milk products to a milk plant from another milk plant, receiving station, or transfer station must meet the identification and shipping requirements in IC 15-18-1-12. A shipping manifest must also indicate the bulk tank unit or units or plant identification number.

SECTION 3. 345 IAC 8-2-5 IS AMENDED TO READ AS FOLLOWS:

Affected: IC 15-18-1

Sec. 5. (a) The following milk or and cream that is unfit for human consumption shall not be allowed to enter into commerce and shall be destroyed:

(b) For the purposes of this rule, when a producer markets his or her milk through a recognized producer's marketing organization, and his or her milk is sent to more than one (1) milk plant, receiving station, or transfer station in any month, the management of the producer's marketing organization shall designate and inform the milk plant, receiving station, or transfer station that receives the milk when it is necessary to make the quality test required by subsections (e) through (j).

(c) Every milk plant, receiving station, or transfer station that receives raw milk or raw cream from a producer of raw milk or raw cream shall have an approved grader of raw milk or raw cream present at all times when such products are received. The approved grader shall inspect and grade the raw milk or raw cream to prevent the receiving entity from accepting raw milk or raw cream that is unfit for human consumption. The grader or graders milk plant, receiving station, or transfer station shall inspect grade and test all raw milk and raw cream as provided for in this rule.

(d) All sediment tests of raw milk required by this rule shall be conducted in accordance with the testing methods contained in the current edition of the standard methods; provided, the regular monthly sediment test or initial test of an individual milk producer's bulk tank raw milk may be conducted on a four (4) ounce sample of raw milk filtered through a filter disk with an exposed area of two-tenths (0.20) inch diameter. When a four (4) ounce sample is used for such a test, the same procedures as those specified for the one (1) pint raw milk mixed sample method shall be used. The method used for conducting sediment tests on milk from farm bulk tanks, tank trucks, and storage tanks shall be the mixed sample method, and the method used for conducting sediment tests of milk received in cans shall be the off-the-bottom method. Milk that is to be tested for sediment by the off-the-bottom method shall not be stirred, mixed, shaken, or handled in any unusual manner by any person or persons prior to the conduct of the sediment test. All equipment, supplies, and facilities used in the sediment testing and grading of raw milk or raw cream shall be:

(e) Every milk plant and receiving station that receives raw milk in cans shall conduct an off-the-bottom sediment test on the milk of each producer at least once each month. In addition, all of the milk in the first delivery from a new can milk producer shall be sediment tested. If the milk is acceptable, thereafter it shall receive the monthly test hereafter described.

(f) If a can milk producer's milk is found to be unfit for human consumption during any test for sediment, all cans of milk in subsequent deliveries of the milk of such producer shall be sediment tested and rejected by any milk plant or receiving station until the grading of such the milk proves the milk to be fit for human consumption. In addition to this follow-up testing, the milk received from any producer of can milk who shipped milk determined to be unfit for human consumption based on the results of the regular monthly test for sediment shall be tested for sediment at least once each week thereafter until all milk in a shipment is fit for human consumption. Such The weekly tests shall be conducted on each can of milk in the shipment or shipments being tested.

(g) Every milk plant, receiving station, and transfer station that receives bulk tank raw milk shall conduct a mixed sample sediment test once per month of each bulk milk producer's milk that is stored in a refrigerated tank on the producer's farm. The milk hauler of the producer's milk shall collect a mixed sample of milk for sediment testing from each refrigerated farm tank and transport all such the samples to the milk plant, receiving station, or transfer station. It shall be the responsibility of the milk plant, receiving station, or transfer station that receives the raw milk to conduct the actual sediment tests by or under the supervision of an approved grader. qualified milk plant personnel.

(h) When an individual bulk milk producer's mixed sample for sediment testing on the routine monthly or initial test establishes that the producer's milk is unfit for human consumption, subsequent offerings of milk from that farm shall be sediment tested on the farm by an approved grader qualified personnel using the one (1) pint mixed sample method prior to being mixed with the milk of any other milk producer. The producer's milk may not be accepted by any:

(i) A mixed sample of milk in the first shipment of a new bulk milk producer or a transfer bulk milk producer shall be collected by the milk hauler and transported to the milk plant, receiving station, or transfer station where it shall be tested for sediment. by an approved grader. If this test shows the milk to be fit for human consumption, thereafter it shall receive the monthly test hereinbefore described. However, if this test shows the milk to be unfit for human consumption, the on-the-farm follow-up testing hereinbefore described shall be done.

(j) Every milk plant, receiving station, or transfer station receiving milk from any producer shall cause a bacterial test to be conducted on a representative sample of each such producer's raw milk at least once each month. A milk hauler of producer's milk shall collect a mixed sample of milk for bacteriological testing from each refrigerated farm tank and transport all such the samples to the milk plant, receiving station, or transfer station. The kind of bacterial test employed shall be approved by the board, and the testing procedures shall be those contained in the current edition of standard methods. Each milk producer shall be notified promptly of the results of tests on his or her milk on forms and in a manner approved by the board. Records of the results of such the tests shall be kept on file for not less than one (1) year.

(k) Every milk plant, receiving station, and transfer station shall make visual and olfactory inspections of all milk and cream received. The inspections shall be made of all milk or cream immediately upon opening the original containers in which the milk or cream is received. All milk or cream found unfit for human consumption shall be rejected.

(l) Milk and cream shall be graded with respect to its sediment content by comparing the sediment tests with the official sediment standard found in the standard methods. Approved graders Milk plants, receiving stations, and transfer stations shall reject all milk and cream which that:

(m) Unfit milk or cream in cans shall be treated by the addition of a harmless red food coloring that has been certified by the U.S. Food and Drug Administration. Sufficient red coloring shall be added to such rejected products to produce a distinct red color in the milk or cream to prevent its being processed or manufactured for food. The approved grader milk plant, receiving station, and transfer station shall affix a tag of uniform type approved by the board to all containers of rejected milk or cream indicating on the tag the reason for the rejection. Under no circumstances shall such tags of rejected milk or cream be removed from a container holding rejected milk or cream except by the producer of such the rejected milk or cream.

(n) Approved graders Qualified milk plant personnel shall identify rejected milk in farm bulk tanks or in bulk milk transportation tank trucks by affixing a tag of uniform type approved by the board to the tank in which the milk is located. The reason for the rejection of the milk shall be stated on the tag. Rejected milk shall not be transported by anyone to a location for manufacture or processing into food. The rejection tag shall remain on the bulk farm tank or bulk milk transportation tank truck until the unfit product has been dumped to waste or removed for salvage for use other than for food.

(o) On the next shipment following a rejection of a producer's milk, a milk plant, receiving station, or transfer station shall not receive more milk (reasonable variations in milk volume being permitted) from that producer than the producer normally ships per delivery.

(p) Every milk plant, receiving station, and transfer station shall keep or cause to be kept a complete system of records, including monthly records of quality tests, all other tests, pickups, and deliveries. Records relating to milk and cream shall be kept by the:

(q) Sediment tests on samples of bulk milk shall be conducted as follows:

SECTION 4. 345 IAC 8-3-1 IS AMENDED TO READ AS FOLLOWS:

Affected: IC 15-17-2; IC 15-18-1

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 (2009 (2011 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 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, 2009. 2012.

(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, 2009. 2012. 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, 2009. 2012. 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, 2009. 2012. 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 110 and 21 CFR 113, in effect on April 1, 2009. 2012. The criteria and definitions in 21 CFR 110, 21 CFR 113 and this rule shall apply in determining whether a food is adulterated under IC 15-18-1 in that the food has been manufactured under such conditions that it is unfit for human food or the food has been prepared, packed, or held under unsanitary conditions under which the product may:

(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 June 1, 2009. 2012.

(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 board. Copies of incorporated documents and interpreting and implementing documents may be obtained from the Food and Drug Administration, Milk Safety Branch website, the U.S. Government Printing Office website, or by sending a written request to the board.

SECTION 5. 345 IAC 8-3-2 IS AMENDED TO READ AS FOLLOWS:

Affected: IC 15-18-1-18

Sec. 2. The following are required to hold a Grade A dairy farm permit:

SECTION 6. 345 IAC 8-3-10 IS AMENDED TO READ AS FOLLOWS:

Affected: IC 15-18-1

Sec. 10. A person operating a Grade A milk plant shall meet the following requirements:

DIN: 20121010-IR-345120107FRA

Composed: Oct 11,2012 11:10:09AM EDT

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