.21 Definitions.

A. In Regulations .21—.34 of this chapter the following terms have the meanings indicated.

B. Terms Defined.

(1) "Adulterated". Frozen desserts or frozen desserts mix shall be deemed to be adulterated if:

(a) It bears or contains any poisonous or deleterious substance in a quantity which may render it injurious to health;

(b) It bears or contains any added poisonous or deleterious substances for which a safe tolerance has not been established by State or federal regulations, or in excess of the tolerance if one has been established;

(c) It consists, in whole or in part, of any substance unfit for human consumption;

(d) It has been produced, processed, prepared, packed, dispensed, or held under insanitary conditions;

(e) Its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or

(f) Any substance has been added, mixed, or packed within the mix to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is.

(2) "CFR" means the Code of Federal Regulations of the United States Government.

(3) "C-I-P" means a procedure by which equipment, pipelines and other facilities are cleaned-in-place in accordance with 3-A Accepted Practices for Permanently Installed Sanitary Product-Pipelines and Cleaning Systems.

(4) "Dispensing freezer" means that type of equipment that freezes reconstituted powdered frozen dessert ingredients or frozen desserts mix into a semi-soft condition for serving to a customer.

(5) "Food service facility" means restaurants, coffee shops, cafeterias, short order cafes, luncheonettes, taverns, sandwich stands, sofa fountains, retail markets, and food operations in industries, institutions, hospitals, clubs, schools, camps, churches, catering kitchens, commissaries, or similar places in which food or drink is prepared for sale or for service on the premises or elsewhere, or any other operation where food is served or provided for the public with or without charge.

(6) "Frozen desserts" means any of the products enumerated in the law, Health-General Article, Title 21, Subtitle 8, and as provided in Regulations .01-1—.20-3 of this chapter.

(7) "Frozen desserts distributor" means any person who offers for sale or sells prepackaged frozen desserts.

(8) "Frozen desserts mix" or "mix" means any frozen dessert in a liquid form, prepared by a frozen desserts plant and intended for freezing before consumption.

(9) "Frozen desserts plant" means any place or premise where frozen desserts or frozen dessert mixes are manufactured, pasteurized, frozen, and packaged.

(10) "Milk products" include milk, cream, and all other products listed under optional dairy ingredients as provided in Regulation .01-1 of this chapter.

(11) "Misbranded". Frozen desserts and frozen desserts mix are misbranded when:

(a) Their containers bear or accompany any false or misleading written, printed, or graphic matter;

(b) Frozen desserts do not conform to their definitions as contained in these regulations; and

(c) Products are not labeled in accordance with Regulation .24 of this chapter.

(12) "National Sanitation Foundation" means the National Sanitation Foundation, NSF Building, P.O. Box 1468, Ann Arbor, Michigan 48106.

(13) "Pasteurization".

(a) The terms "pasteurization", "pasteurized", and similar terms mean the process of heating, in approved and properly operated equipment, every particle of mix containing milk and milk products to one of the following minimum temperatures and holding at this temperature continuously for the specified time as indicated below:

(i) 155F and holding at that temperature for at least 30 minutes;

(ii) 175F and holding at that temperature for at least 25 seconds;

(iii) 180F and holding at that temperature for at least 15 seconds;

(iv) 194F and holding at that temperature for at least 0.5 second.

(b) Nothing contained in this section shall be construed as barring any other method or process, as may be demonstrated to be equally efficient and which is approved by the Secretary.

(14) "Person" means any individual, partnership, firm, corporation, or association.

(15) "Powdered frozen dessert ingredients" means any dry mixture of pasteurized dry milk products, including whey, reduced mineral whey, whey protein concentrate, reduced lactose whey, or optional casseinates, which is intended for reconstitution, freezing, and retail sale by a food service facility.

(16) "Retail frozen desserts manufacturer" means a person who manufactures frozen desserts from commercially supplied pasteurized mix derived from raw milk supplies having acceptable United States Public Health Service (U.S.P.H.S.) ratings, for retail sale directly to the consumer on the premises where manufactured.

(17) "Sanitization" means the application of any effective method or substance to a clean surface for the destruction of pathogens, and of other organisms as far as is practicable. This treatment may not adversely affect the equipment, frozen desserts, or the health of consumers, and shall be acceptable to the Secretary.

(18) "Secretary" means the Secretary of Health or his designee.

(19) "3-A Standards" means the standards for dairy equipment and accepted practices formulated by the 3-A Sanitary Standards Committee representing the International Association of Milk, Food and Environmental Sanitarians, the U.S. Public Health Service, and the Dairy Industry Committee, as published by the Journal of Food Protection, P.O. Box 701, Ames, Iowa 50010.

(20) "Wholesale frozen desserts manufacturer" means a person who manufactures, pasteurizes, packages, or freezes any frozen desserts mix for distribution or sale other than for retail sale directly to the consumer on the premises where manufactured.