Hawaii Administrative Rules
Title 11 - DEPARTMENT OF HEALTH
Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS
Chapter 15 - MILK
Section 11-15-2 - Definitions

Current through February, 2024

As used in this chapter:

"Adulterated milk and milk products" means any milk or milk product that is found to be adulterated within the meaning of section 328-9, HRS.

"Aseptically processed milk and milk products" means milk and milk products so thermally processed and hermetically sealed in a container in conformance with 21 CFR Part 113 and the provisions of this chapter as to render the product free of microorganisms capable of reproducing in the product under normal non-refrigeration conditions of storage and distribution. The product shall be free of viable microorganisms (including spores) of public health significance.

"Aseptic processing" or "aseptic processed" is the process to produce aseptically processed milk and milk products.

"Bulk milk pickup tanker" means a vehicle including the truck, tank, and those appurtenances necessary for its use, which is used by a milk hauler to transport bulk raw milk for pasteurization from a dairy farm to a transfer station, receiving station, or milk plant.

"Dairy farm" means any place or premise where one or more cows or goats are kept, and from which a part or all of the milk or milk product from the cows or goats is provided, sold, or offered for sale to a milk plant, transfer station, or receiving station.

"Department" means the department of health of the State of Hawaii.

"Director" means the director of health of the State of Hawaii or a duly authorized agent or representative.

"Hermetically sealed container" means a container which has been approved as a hermetically sealed container by the United States Food and Drug Administration or is designed and intended to be secure against the entry of microorganisms and thereby maintain the commercial sterility of its contents after processing.

"Homogenized" or "homogenization" means a milk or a milk product which has been treated to insure breakup of the fat globules to such an extent that, after forty-eight hours of quiescent storage at 45°F(7°C), no visible cream separation occurs on the milk or milk product and the fat percentage of the top one hundred milliliters of milk in a quart, or of proportionate volumes in containers of other sizes, does not differ by more than ten per cent from the fat percentage of the remaining milk or milk product as determined after thorough mixing.

"Milk distributor" means any person who offers for sale or sells to another any milk or milk products.

"Milk hauler" means any person who transports raw milk or raw milk products, or both, to or from a milk plant, receiving station, or transfer station.

"Milk plant" means any place, premise, or establishment where milk or milk products are collected, handled, processed, stored, pasteurized, ultra-pasteurized, aseptically processed, bottled, or prepared for distribution.

"Milk producer" or "producer" means any person who operates a dairy farm and provides, sells, or offers any milk for sale to a milk plant, receiving station, or transfer station.

"Milk products" mean and include cream, light cream, light whipping cream, heavy cream, heavy whipping cream, whipped cream, whipped light cream, sour cream, acidified sour cream, cultured sour cream, half-and-half, sour half-and-half, acidified sour half-and-half, cultured half-and-half, reconstituted or recombined milk and milk products, concentrated milk, concentrated milk products, skim milk, lowfat milk, frozen milk concentrate, eggnog, buttermilk, cultured milk, cultured lowfat milk, cultured skim milk, yogurt, lowfat yogurt, nonfat yogurt, acidified milk, acidified lowfat milk, acidified skim milk, reduced-sodium milk, reduced-sodium lowfat milk, reduced-sodium skim milk, lactose-reduced milk, lactose-reduced lowfat milk, lactose-reduced skim milk, imitation milk and milk products, substitute milk and milk products, aseptically processed and packaged milk and milk products as defined in this section, and milk, lowfat milk or skim milk with added safe and suitable microbial organisms. This definition does not include milk products such as evaporated milk, evaporated skim milk, condensed milk (sweetened or unsweetened), dietary products (except as defined herein), infant formula, ice cream and other frozen desserts, dry milk products (except as defined herein), canned eggnog in a rigid metal container, butter or cheese except when they are combined with other substances to produce any pasteurized or aseptically processed milk or milk product defined in this section.

"Milk tank truck" means both a bulk milk pickup tanker and a milk transport tank.

"Milk transport tank" means a vehicle including the truck and tank used by a milk hauler to transport bulk shipments of milk from a transfer station, receiving station, or milk plant to another transfer station, receiving station, or milk plant.

"Misbranded milk and milk products" means products found to be misbranded within the meaning of section 328-10, HRS.

"Official laboratory" means a biological, chemical, or physical laboratory which is under the supervision of the director.

"Officially designated laboratory" means a commercial laboratory or a milk industry laboratory certified by the director for the examination of producer samples of Grade "A" raw milk for pasteurization and commingled milk tank truck samples of raw milk for antibiotic residues and bacterial limits.

"Ordinance" means the Grade "A" Pasteurized Milk Ordinance, 1978, Recommendations of the United States Public Health Service, Food and Drug Administration, Publication No. 22 9, United States Department of Health, Education, and Welfare, as amended.

"Pasteurization" or "pasteurized" means the process of heating every particle of milk or milk product in properly designed and operated equipment to one of the temperatures given in the following table, and held continuously at or above that temperature for at least the corresponding specified time:

*If the fat content of the milk product is ten percent or more, or if the milk product contains added sweeteners, the specified temperature shall be increased by 5°F (3°C); provided, that eggnog shall be heated to at least the following temperature and time specifications:

Provided further, that nothing in this definition shall be construed as barring any other pasteurization process which has been recognized by the United States Food and Drug Administration to be equally efficient and which is approved by the director.

"Receiving station" means any place, premise, or establishment where raw milk is received, collected, handled, stored, or cooled and prepared for further transporting.

"Safe and suitable" means that the ingredient:

(1) Performs an appropriate function in the food in which it is used;

(2) Is used at a level no higher than necessary to achieve its intended purpose in that food; and

(3) Is a food additive or color additive as defined in section 328-1, HRS, and is used in conformity with regulations established pursuant to section 409 or 706 of the Federal Food, Drug and Cosmetic Act.

"Sanitization" or "sanitizing" means the application of any effective method or substance to a clean surface for the destruction of pathogens and other organisms as is practicable. Such treatment shall not adversely affect the equipment, the milk or milk product, or the health of consumers, and shall be acceptable to the director.

"Transfer station" means any place, premise, or establishment where milk or milk products are transferred directly from one transport tank to another.

" 21 CFR" means Title 21 Code of Federal Regulations, effective April 1, 1989, unless otherwise specified in this chapter.

"Ultra high temperature," or "UHT" means that the milk or milk product has been subject to aseptic processing.

"Ultra-pasteurized" means a milk or milk product that has been thermally processed at or above 280°F (138°C) for at least two seconds, either before or after packaging, so as to produce a product which has an extended shelf life under refrigerated conditions.

"Ungraded" means other than Grade "A."