HAR §11-15-39. Labeling

(a) All bottles, containers, and packages enclosing milk or milk products defined in this chapter shall be labeled in accordance with the applicable requirements of this chapter, the Federal Food, Drug and Cosmetic Act as amended and the Federal Fair Packaging and Labeling Act and regulations developed thereunder. (b) All bottles, containers, and packages enclosing milk or milk products except milk tank trucks, storage tanks, and cans of raw milk from individual dairy farms shall be conspicuously marked with: (1) The words "Grade A" except that this requirement shall not apply to imitation milk or milk products, substitute milk or milk products, and "ungraded" milk or milk products; (2) The word "pasteurized" if the contents are pasteurized; (3) The volume or proportion of water to be added for reconstituting or recombining in the case of concentrated milk or milk products; (4) The words "Keep refrigerated after opening" in the case of aseptically processed milk and milk products; (5) The words "ultra-pasteurized" if the milk or milk product has been ultra-pasteurized; (6) In the case of aseptically processed and packaged milk or milk products: "ultra high temperature" or "UHT;" (7) The word "Goat" preceding the name of the milk or milk product when the product is or is made from goat milk; and (8) The identity of the plant where pasteurized, ultra-pasteurized or aseptically processed. (c) Every container of processed milk and milk product held in retail and wholesale stores, restaurants, schools, or similar establishments for sale shall be conspicuously and legibly marked by the milk plant with the designation of the month and day of the month after which the milk shall not be sold for human consumption. If the director determines that the quality of a milk or milk product deteriorates to the extent that the product becomes unmarketable prior to its designated shelf-life, the director shall notify the milk plant to conduct a full and complete review of the shelf-life of the product. If the review confirms that the designated shelf-life of the product is improper, the milk plant shall immediately shorten the designated shelf-life of the product in order to maintain the quality of the product throughout its intended shelf-life. (d) All vehicles and milk tank trucks containing milk or milk products shall be legibly marked with the name and address of the milk plant or hauler in possession of the contents. (e) Milk tank trucks transporting raw milk and milk products to a milk plant from sources of supply not under the routine supervision of the director are required to be marked with the name and address of the milk plant or hauler and shall be sealed; in addition, for each such shipment, a shipping statement shall be prepared containing at least the following information: (1) Shipper's name, address, permit number; (2) Permit identification of hauler, if not employee of shipper; (3) Point of origin of shipment; (4) Tanker identity number; (5) Name of product; (6) Weight of product; (7) Grade of product; (8) Temperature of product; (9) Date of shipment; (10) Name of supervising regulatory agency at the point of origin; and (11) Whether the contents are raw, pasteurized, or in the case of cream, lowfat, or skim milk whether it has been heat-treated. One copy of the shipping statement shall be retained by the consignor, one by the common carrier and at least two copies shall be delivered to the consignee with the shipment. The consignee shall forward at least one copy to the director. Entries made on shipping statements by consignors or consignees shall be legible. When the interstate shipment is derived from more than one point of origin, separate shipping statements for each of the sources involved shall accompany the shipment. Shipping statements shall be retained on file for a period of at least six months. (f) All cans of raw milk from individual dairy farms shall be identified by the name or number of the individual milk producer. [Eff. AUG 14 1989] (Auth: HRS §§321-11, 328-8) (Imp: HRS §§321-11, 328-8) §11-15-40 Inspection of dairy farms and milk plants. (a) Each dairy farm, milk plant, receiving station, and transfer station whose milk or milk products are intended for consumption within the State of Hawaii shall be inspected by the director prior to the issuance of a permit. Following the issuance of a permit, each dairy farm and transfer station shall be inspected at least once every six months and each milk plant and receiving station shall be inspected at least once every three months. Should the violation of any requirement set forth in sections 11-15-42, 11-15- 43, and 11-15-44 be found to exist on an inspection, a second inspection shall be required after the time deemed necessary to remedy the violation has passed, but not before three days. This second inspection shall be used to determine compliance with the requirements of sections 11-15-42, 11-15-43, and 11- 15-44. Any violation of the same requirements of sections 11-15-42, 11-15-43, and 11-15-44 on a second inspection shall be subject to permit suspension in accordance with section 11-15-38 or the institution of penalties as provided for in section 11-15-53, or both. (b) When an inspection of a milk plant reveals that the process for manufacturing aseptically processed milk or milk products is less than that required for aseptic processing, it shall constitute an imminent health hazard and the director shall, in accordance with section 11-15-38, take immediate action to suspend the permit to produce aseptically processed milk or milk products. (c) One copy of the inspection report shall be handed to the operator, or other responsible person, or be posted in a conspicuous place on an inside wall of the establishment. The inspection report shall not be defaced and shall be made available to the director upon request. An identical copy of the inspection report shall be filed with the records of the director. (d) Every milk producer, hauler, distributor, or plant operator shall, upon request of the director, permit access to all parts of the establishment or facilities to determine compliance with the provisions of this chapter. A distributor or plant operator shall furnish the director, upon request, for official use only: (1) A true statement of the actual quantities of milk and milk products of each grade purchased and sold; (2) A list of all sources of the milk and milk products; (3) Records of inspections and tests; and (4) Pasteurization time and temperature records. [Eff. AUG 14 1989] (Auth: HRS §§321-11, 323-8) (Imp: HRS §§321-11, 328-8, 328-22, 328-23) §11-15-41 The examination of milk and milk products. (a) During any consecutive six months, at least four samples of raw milk for pasteurization shall be taken by the director from each producer and four samples of raw milk for pasteurization, ultra- pasteurization or aseptic processing taken by the director from each milk plant after receipt of the milk by the milk plant and prior to pasteurization, ultra-pasteurization or aseptic processing. In addition, during any consecutive six months, at least four samples of pasteurized and ultra-pasteurized milk and at least four samples of each milk product defined in this chapter, except aseptically processed milk or milk products, shall be taken by the director from every milk plant. Samples of milk and milk products shall be taken while in possession of the producer or distributor at any time prior to delivery to the store or consumer. The producer or distributor shall incorporate a system which will enable the director to collect required samples. Samples of milk and milk products from retail stores, food service establishments, and other places where milk and milk products are sold shall be examined periodically as determined by the director, and the results of the examination shall be used to determine compliance with sections 11-15-37, 11-15-39, and 11-15-47. Proprietors of such establishments shah furnish, upon the director's request, the names of all distributors from whom milk or milk products are obtained. (b) Required bacterial counts, somatic cell counts, cooling temperature checks, and antibiotic tests shall be performed on raw milk for pasteurization. In addition, pesticide residue tests on raw milk shall be performed periodically as determined by the director. When commingled milk is tested, all producers shall be represented in the sample. All individual sources of milk shall be tested when test results on the commingled milk are positive. Required bacterial counts, antibiotic tests, coliform determination, phosphatase, and cooling temperature checks shall be performed on pasteurized milk and milk products. Pesticide residue tests on pasteurized milk and milk products shall be performed periodically as determined by the director. All of the above tests and checks are to be performed by the director. (c) Except for aseptically processed milk and milk products, whenever two of the last four consecutive bacterial counts, somatic cell counts, cooling temperatures, taken on separate days exceed the limit of the standard for the milk or milk product as set forth in section 11-15-42, the director shall send a written notice informing the permittee that the permit may be suspended if an additional sample exceeds the standard. This notice shall remain in effect as long as two of the last four consecutive samples exceed the limit of the standard. An additional sample shall be taken within twenty-one days of the sending of the notice, but not before the lapse of three days. Except for aseptically processed milk and milk products, whenever three of the last five consecutive bacterial counts, somatic cell counts, cooling temperatures, or coliform determinations, taken on separate days exceed the limit of the standard for the milk or milk product as set forth in section 11-15-42, the director shall send a written notice of intent to suspend the Grade "A" milk permit to the permittee as stipulated in section 11-15-38(d). When more than one milk or milk product is included on a permit, the suspension shall apply to the milk or milk product in violation of this chapter, and shall not affect other milk and milk products which meet the requirements of this chapter. (d) Whenever a phosphatase test is positive, the cause shall be determined. Where the cause is known or suspected to be improper pasteurization, it shall be corrected by the permittee, and any milk or milk product involved shall not be offered for sale. (e) Whenever an antibiotic or pesticide residue test exceeds the limit established by this chapter, the United States Food and Drug Administration, or the United States Environmental Protection Agency, an investigation shall be made determine the cause, and the problem shall be corrected by the permittee. No milk shall be offered for sale until it is shown by a subsequent sample that the milk is free of antibiotic or pesticide residues or below the limit established for such residues. (f) Whenever an aseptically processed milk or milk product is found to be unsterile due to under- processing, the director shall consider this to be an imminent hazard to public health. All product from the lot that was found to contain one or more unsterile units shall be removed from sale and disposed of as directed by the director. No aseptically processed milk and milk product shall be sold from the milk plant until it can be shown to the satisfaction of the director that the processes, equipment and procedures used are suitable for consistent production of a sterile product. (g) Samples shall be analyzed by an official laboratory or an officially designated laboratory. All sampling procedures and required laboratory examinations shall be in Methods for the Examination of Dairy Products," a 1985 publication of the American Public Health Association, and the fourteenth edition, 1984, of the "Official Methods of Analyses of the Association of Official Analytical Chemists." Procedures and examinations shall be evaluated in accordance with the Evaluation of Milk Laboratories, 1978 Recommendations of the United States Public Health Service/Food and Drug Administration. Aseptically processed milk and milk products packaged in hermetically sealed containers shall be tested in accordance with Chapter 23 of the United States Food and Drug Administration's Bacteriological Analytical Manual, sixth edition, 1984. Examinations and tests shall be conducted to detect adulterants, as the director shall require. Assays of milk or milk products to which vitamins A or D have been added shall be made by the milk plant at least annually in a laboratory acceptable to the director for such examinations and at no cost to the director. [Eff. AUG 14 1989] (Auth: HRS §§321-11, 328-8) (Imp: HRS §§321-11, 328-6, 328-8, 328-9, 328-10, 328-22, 328-23, 328-24)