(1) This rule applies only to ice that is intended for human consumption and is sold in packaged form or in bulk form for food, drink or culinary purposes. This rule does not apply to persons, hotels, restaurants, inns, caterers, food service contractors, or theaters that manufacture or furnish ice solely to or for their customers in a manner that is incidental to the production, sale or dispensing of other goods and services.

(2) Natural ice that is cut from water on a stream, creek, river, lake, pond, or other body of surface water may not be used as ice for human consumption.

(3) Except as provided in (1) above, any person who manufactures, transports, distributes, sells or provides ice, with or without charge, to the public must obtain a food manufacturing license and must comply with these rules and with the statutes governing food manufacturing establishments, 50-50-101 et seq., MCA; the rules governing food manufacturing establishments, ARM 37.110.301, et seq.; and the rules governing public water systems, ARM 17.38.201 et seq.

(4) Ice plants must be operated in a clean and sanitary manner. The room in which ice production occurs may not be used for any purposes other than ice or food production and the storage and refrigeration of ice or food.

(5) Ice production facilities shall meet the provisions of 21 CFR 110, which provides standards for current good manufacturing practice in manufacturing, packing, or holding human food.

(6) Ice produced and packaged for sale to the public must be labeled in accordance with the Montana Food, Drug and Cosmetic Act, Title 50, chapter 31, MCA, and in accordance with 21 CFR 101, which establishes federal food labeling standards, and must display legible labeling including, but not limited to, the identity of the product, the net weight or contents of the package, and the name and place of business of the manufacturer, packer, distributor, seller, or provider.

(7) Packaged ice transportation, hauling vehicles, and bulk containers, including display or storage freezers, are regarded as a part of the licensed premises and are subject to review or inspection by the department or the local health officer, sanitarian, or sanitarian-in-training employed by or contracted with the local board of health having jurisdiction, prior to issuance or renewal of its license or on a regular annual inspection.

(8) The food manufacturing establishment must sample and have analyzed its manufactured ice products, and the waters from which the ice is made, at least once a month for compliance with the maximum microbiological contaminant levels contained in ARM 17.38.207, and send the results to the department. The food manufacturing establishment is also required to comply with the bacteriological quality sampling provisions of ARM 17.38.215(3) through (7) for transient non-community water systems. The department may increase the required sampling frequency based upon sampling results or other conditions which indicate an increased risk to the health of the users of the product. The department may decrease the required sampling frequency to quarterly or biannually based on a showing that the source consistently does not contain the contaminant, is either a community water system or a groundwater source not under direct influence of surface water, and that the samples consistently meet the required sanitary standards, rendering the source and operation generally not vulnerable to microbiological contamination.

(9) The delivery of ice to the customer must be done under sanitary conditions. Ice must be packaged in durable freezable containers labeled in conformance with the labeling requirements as described in (6) above. Boxes or containers intended for non-food use or for use in packaging another food are not acceptable transport containers. All boxes, containers, cases or contact surfaces within bins or transport vehicles must be constructed of food grade materials.

(10) Natural or manufactured ice that does not conform to standards set forth in this rule must be conspicuously identified or labeled as unsafe or inedible and may not be sold or distributed for human consumption. Such ice may be used for cooling or refrigeration purposes only if such use does not permit it to come in direct contact with food or drink meant for human consumption. If such ice is sold or distributed for refrigeration purposes, the seller or distributor must notify the buyer or consumer that it is not safe for human consumption.

(11) The department hereby adopts by reference ARM 37.110.301 et seq., setting standards for food manufacturing establishments; ARM 17.38.201, et seq., setting standards for public water supply systems; 21 CFR 110, setting standards for packing, manufacturing, or holding human food; and 21 CFR 101, setting food labeling standards. Copies of these rules may be obtained, upon payment of copying costs, from the Department of Public Health and Human Services, Food and Consumer Safety Section, 1400 Broadway, P.O. Box 202951, Helena, Montana 59620-2951.