| (h) Pasteurization. When pasteurization is required, or when a product is designated "pasteurized," every particle of the milk or milk product shall be subjected to such temperatures and holding periods in properly designed and operated equipment sufficient to ensure proper pasteurization of the product in accordance with the most current revision of the "Grade A Pasteurized Milk Ordinance." Provided, that nothing shall be construed as barring any other process found equivalent to pasteurization for milk and milk products, which has been recognized by FDA as provided in 21 U.S.C. §343(h)(3) of the Federal Food, Drug and Cosmetic Act. Only such FDA recognized processes and no other shall be considered by the department. (i) Composition and wholesomeness. All necessary precautions shall be taken to prevent contamination or adulteration of the milk or dairy products during manufacturing in accordance with these rules. All substances and ingredients used in the processing or manufacturing of any dairy product shall be subject to inspection and shall be wholesome and practically free from impurities. (j) Cleaning and sanitizing treatment. (1) All multi-use containers and utensils shall be thoroughly cleaned after each use and all equipment shall be thoroughly cleaned at least once each day used, unless the department has reviewed and accepted information, in consultation with FDA, supporting the cleaning of multi-use containers and utensils at frequencies extending beyond one day or 72 hours in the case of storage tanks, or 44 hours in the case of evaporators, which are continuously operated. Approval by the department will be conveyed in writing. Supporting information shall be submitted to and approved by the department prior to initiating the qualification period if required. Any significant equipment or processing changes shall be communicated to the department, and may result in a re-verification of the extended run proposal, if it is determined that the change could potentially affect the safety of the finished milk or milk product(s). The supporting information may include but is not limited to: (A) statement of proposal, including desired cleaning frequency; (B) product and equipment description; (C) intended use and consumers; (D) distribution and storage temperatures of product; (E) diagram of process of interest; (F) process parameters, including temperature and times; (G) hazard evaluation and safety assessment; and (H) review of equipment for sanitary design. (2) When indicated by a hazard evaluation and safety assessment, a plan for initial qualification shall be developed to address identified critical process parameters. (3) Storage tanks shall be cleaned when emptied and shall be emptied at least every 72 hours. Records must be available to the department to verify that milk storage in these tanks does not exceed 72 hours. These records shall be available for at least the previous three months or from the time of the last regulatory inspection, whichever is longer. Storage tanks, which are used to store raw milk or milk products or heat-treated milk products longer than 24 hours and silo tanks used for the storage of raw milk or milk products or heat-treated milk products shall be equipped with a seven day temperature recording device complying with the specifications of the most current revision of the Grade A Pasteurized Milk Ordinance. (4) Evaporators shall be cleaned at the end of a continuous operation, not to exceed 44 hours, and records must be available to the department to verify that the operation time does not exceed 44 hours. Drying equipment, cloth-collector systems, packaging equipment and multi-use dry milk products and dry whey storage containers shall be cleaned at intervals and by methods recommended by the manufacturer and approved in writing by the department. Such methods may include cleaning without water by use of vacuum cleaners, brushes, or scrapers. After cleaning, such equipment is sanitized by a method approved in writing by the department. Cloth collector systems and all dry product-contact surfaces downstream from the dryer shall be sanitized or purged at intervals and by methods recommended by the manufacturer and approved by the department. Storage bins used to transport dry milk or milk products shall be dry cleaned after each usage and washed and sanitized at regular intervals. (5) All milk tank trucks that transport milk and milk products shall be washed and sanitized at a permitted milk plant, receiving station, transfer station, or milk tank truck cleaning facility. The milk tank truck shall be cleaned and sanitized prior to its first use. When the time elapsed after cleaning and sanitizing, and before its first use, exceeds 96 hours, the tank must be re-sanitized. Whenever a milk tank truck has been cleaned and sanitized, as required by the department, it shall bear a tag or a record shall be made showing the date, time, place and signature or initials of the employee or contract operator doing the work, unless the milk tank truck delivers to only one receiving facility where responsibility for cleaning and sanitizing can be definitely established without tagging. The tag shall be removed at the location where the milk tank truck is next washed and sanitized and kept on file for 15 days. (6) Pipelines and/or equipment designed for mechanical cleaning shall meet the following requirements. (A) An effective cleaning and sanitizing regimen for each separate cleaning circuit shall be followed. (B) A temperature recording device, complying with the most current revision of the Grade A Pasteurized Milk Ordinance, or a recording device which provides sufficient information to adequately evaluate the cleaning and sanitizing regimen which is approved by the department in writing, shall be installed in the return solution line or other appropriate area to record the temperature and time during which the line or equipment is exposed to cleaning and sanitizing solutions. For purposes of this section, recording devices which produce records not meeting the specifications of the most current revision of the "Grade A Pasteurized Milk Ordinance" may be acceptable if: (i) the device provides a continuous record of the monitoring of the cleaning cycle time and temperature, cleaning solution velocity or cleaning pump operation and the presence or strength of cleaning chemicals for each cleaning cycle; (ii) the record shows a typical pattern of each circuit cleaned, so that changes in the cleaning regimen may be readily detected; or (iii) electronic storage of required cleaning records, with or without hard copy printouts, may be acceptable, provided, the electronically generated records are readily available. Electronic records must meet the criteria of this section and those provisions of with the most current revision of the Grade A Pasteurized Milk Ordinance, which are determined to be applicable by the department and FDA. Except that, electronic storage of required cleaning records, with or without hard copy, shall be acceptable, provided the computer and computer generated records are readily available and meet the criteria of this section and Title 21, CFR, Part 11. (k) Packaging and labeling. (1) Containers: (A) The size, style, and type of packaging used for dairy products shall be packaged in materials which will cover and protect the quality of the contents during storage and regular channels of trade and under conditions of handling. The weights and shape within each size or style shall be as nearly uniform as is practical. (B) Packaging materials for dairy products shall be selected which will provide sufficiently low permeability to air and vapor to prevent the formation of mold growth and surface oxidation. In addition, the wrapper shall be resistant to puncturing, tearing, cracking, or breaking under normal conditions of handling, shipping, and storage. When special-type packaging is used, the instructions of the manufacturers shall be followed closely as to its application and methods of closure. (2) Packaging and repackaging. Packaging dairy products or cutting and repackaging all styles of dairy products shall be conducted under rigid sanitary conditions. The atmosphere of the packaging rooms, the equipment and packaging material shall be free from mold and bacterial contamination. Methods for checking the level of contamination shall be as prescribed by the most current edition of "Standard Methods for the Examination of Dairy Products" of the American Public Health Association as defined in §217.1 of this title (relating to Definitions). (3) Labeling. All commercial bulk packages containing dairy products manufactured under the provisions of this subpart shall be adequately and legibly marked with the name of the product, name and address of processor or manufacturer or other assigned plant identification, lot number, and any other identification as may be required by the department. Consumer packaged products shall be legibly marked with the name of the product, name and address of packer, manufacturer, or distributor. (l) Storage of finished product. (1) Dry storage. The product shall be stored at least 18 inches from the wall in aisles, rows, or sections and lots, in such a manner as to be orderly and easily accessible for inspection. Rooms should be cleaned regularly. Care shall be taken in the storage of any other product foreign to dairy products in the same room, in order to prevent impairment or damage to the dairy product from mold, absorbed odors, or vermin or insect infestation. Control of humidity and temperature shall be maintained at all times to prevent conditions detrimental to the product and container. (2) Refrigerated storage. The finished product shall be placed on shelves, dunnage, or pallets and identified. It shall be stored under temperatures that will best maintain the initial quality. The product shall not be exposed to anything from which it might absorb any foreign odors or be contaminated by drippage or condensation. |
