packaging and handling of dairy products, and to perform dairy plant surveys in accordance with the regulations of this part.

(j) Inspection or grading service. Means in accordance with this part, the act of (1) drawing samples of any product; (2) determining the class, grade, quality, composition, size, quantity, condition, or wholesomeness of any product by examining each unit or representative samples; (3) determining condition of product containers; (4) identifying any product or packaging material by means of official identification; (5) regrading or appeal grading of a previously graded product; (6) inspecting dairy plant facilities, equipment, and operations; such as, processing, manufacturing, packaging, repackaging, and quality control; (7) supervision of packaging inspected or graded product; (8) reinspection or appeal inspection; and (9) issuing an inspection or grading certificate or sampling, inspection, or other report related to any of the foregoing.

(k) Milk. The whole lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows located in modified accredited areas and modified certified areas or from cows in herds fully accredited as tuberculosis-free and certified brucellosis-free by the United States Department of Agriculture or in the process of being accredited.

Official

(1) Official identification. identification is provided for use on product packed under USDA inspection. Any package label or packaging material which bears any official identification shall be used only in such manner as the Administrator may prescribe, and such official identification shall be of such form and contain such information as the Administrator may require.

(m) Official methods. Official Methods of Analysis of the Association of Official Analytical Chemists, a publication of the Association of Official Analytical Chemists, Box 540, Benjamin Franklin Station, Washington, D.C. 20044.

(n) Pasteurization (Pasteurized). Pasteurization shall mean that every particle of product shall have been heated in properly operated equipment to one of the temperatures specified in the table and held continuously at or above that temperature for at least the specified time (or other time/temperature rela

(0) Plant survey. An appraisal of a plant to determine the extent to which facilities, equipment, method of operation, and raw material being received are in accordance with the provisions of this part. The survey shall be used to determine suitability of the plant for USDA inspection or grading service.

(p) Plant status. The extent to which a plant complies with this subpart shall be determined under procedures as set forth by the Administrator.

(q) Producer. The person or persons who exercise control over the production of the milk delivered to a processing plant or receiving station and who receive payment for this product.

(r) Quality control. The inspection of the quality of the raw material and the conditions relative to the preparation of the product from its raw state through each step in the entire process. It includes the inspection of conditions under which the product is prepared, processed, manufactured, packed and stored. In addition, assistance and guidance is offered to improve the raw milk quality, processing methods, quality, stability, and packaging and handling of the finished product.

(s) Regulations. The term “regulations" means the provisions contained in this part.

(t) Shall. Expresses a provision that is mandatory.

(u) Should. Expresses recommended nonmandatory provisions which when followed would significantly aid in a quality improvement program.

(v) Standard methods. Standard Methods for the Examination of Dairy Products, a publication of the American Public Health Association, 1790 Broadway, New York, New York.

(w) 3-A Sanitary Standards and Accepted Practice. The latest standards for dairy equipment and accepted practices formulated by the 3-A Sanitary Standards Committees representing the International Association of Milk, Food and Environmental Sanitarians, the Food and Drug Administration and the Dairy Industry Committee. Published by the International Association of Milk, Food and Environmental Sanitarians, Box 701, Ames, Iowa.

(x) “USDA" or "Department". Means the United States Department of Agriculture.

(y) Receiving Station. Any place, premise, or establishment where milk or dairy products are received, collected or handled for transfer to a processing or manufacturing plant.

(z) Transfer station. Any place, premise, or establishment where milk or dairy products are transferred directly from one transport tank to another.

(aa) Corrorison-resistant. Those materials that maintain their original surface characteristics under prolonged influence of the product to be contacted, cleaning compounds and sanitizing solutions, and other conditions of the environment in which used.

PURPOSE

§ 58.122 Approved Plants under USDA inspection and grading service.

(a) Adoption of certain sound practices at dairy plants will significantly aid the operators to manufacture more consistently, uniform high-quality stable dairy products. Only dairy products manufactured, processed and packaged in an approved plant may be graded or inspected and identified with official identification. The specifications established herein provide the basis for a quality maintenance program which may be effectively carried forward through

official inspection, grading, and quality control service.

(b) USDA inspection and grading service is provided to dairy product manufacturing plants on a voluntary basis. The operator of any dairy plant desiring to have such a plant qualified as an approved plant under USDA inspection and grading service may request surveys of such plant, premises, equipment, facilities, methods of operation, and raw material to determine whether they are adequate to permit inspection and grading service. The cost of this survey shall be borne by the applicant.

APPROVED PLANTS

§ 58.123 Survey and approval.

Prior to the approval of a plant, a designated representative of the Administrator shall make a survey of the plant, premises, storage facilities, equipment and raw material, volume of raw material processed daily, and facilities for handling the products at the plant. The survey shall be made at least twice a year to determine whether the facilities, equipment, method of operation, and raw material being received are adequate and suitable for USDA inspection and grading service in accordance with the provisions of this part. To be eligible for approval a plant shall satisfactorily meet the specifications of this subpart as determined by the Administrator.

§ 58.124 Denial or suspension of plant approval.

Plant approval may be denied or suspended if a determination is made by a designated representative of the Administrator that the plant is not performing satisfactorily in regard to; (a) the classification of milk, (b) proper segregation and disposal of unwholesome raw materials or finished product, (c) adequate facilities and condition of processing equipment, (d) sanitary conditions of plant and equipment, (e) control of insects, rodents and other vermin, (f) use of non-toxic product contact surfaces and prevention of adulteration of raw materials and products with chemicals or other foreign material, (g) proper operating procedures, (h) the maintenance of legal composition of finished products, (i) the manufacture of stable dairy products, of desirable keeping quality characteristics, (j) proper storage conditions for ingredients and dairy products, or (k) suitable and effective packaging methods and material.

(a) The premises shall be kept in a clean and orderly condition, and shall be free from strong or foul odors, smoke, or excessive air pollution. Construction and maintenance of driveways and adjacent plant traffic areas should be of cement, asphalt, or similar material to keep dust and mud to a minimum.

(b) Surroundings. The immediate surroundings shall be free from refuse, rubbish, overgrown vegetation, and waste materials to prevent harborage of rodents, insects and other vermin.

(c) Drainage. A suitable drainage system shall be provided which will allow rapid drainage of all water from plant buildings and driveways, including surface water around the plant and on the premises, and all such water shall be disposed of in such a manner as to prevent an environmental or health hazard. § 58.126

Buildings.

The building or buildings shall be of sound construction and shall be kept in good repair to prevent the entrance or harboring of rodents, birds, insects, vermin, dogs, and cats. All service pipe openings through outside walls shall be effectively sealed around the opening or provided with tight metal collars.

(a) Outside doors, windows, openings, etc. All openings to the outer air including doors, windows, skylights and transoms shall be effectively protected or screened against the entrance of flies and other insects, rodents, birds, dust and dirt. All outside doors opening into processing rooms shall be in good condition and fit properly. All hinged, outside screen doors shall open outward. All doors and windows should be kept clean and in good repair. Outside, conveyor openings and other special-type outside openings shall be effectively protected to prevent the entrance of flies and rodents, by the use of doors, screens, flaps, fans or tunnels. Outside openings for sanitary pipelines shall be covered when not in use. On new construction window sills should be slanted downward at approximately a 45° angle.

(b) Walls, ceilings, partitions and posts. The walls, ceilings, partitions, and posts of rooms in which milk, or dairy products are processed, manufactured, handled, packaged or stored (except dry storage of packaged finished

products and supplies) or in which utensils are washed and stored, shall be smoothly finished with a suitable material of light color, which is substantially impervious to moisture and kept clean. They shall be refinished as often as necessary to maintain a neat, clean surface. For easier cleaning new construction should have rounded cove at the juncture of the wall and floor in all receiving, pasteurizing, manufacturing, packaging and storage rooms.

(c) Floors. The floors of all rooms in which milk, or dairy products are processed, manufactured, packaged or stored or in which utensils are washed shall be constructed of tile properly laid with impervious joint material, concrete, or other equally impervious material. The floors shall be smooth, kept in good repair, graded so that there will be no pools of standing water or milk products after flushing, and all openings to the drains shall be equipped with traps properly constructed and kept in good repair. On new construction, bell and standpipe type traps shall not be used. The plumbing shall be so installed as to prevent the back-up of sewage into the drain lines and to the floor of the plant. Cold storage rooms used for storage of product and starter rooms need not be provided with floor drains if the floor is sloped to drain to an exit.

Sound, smooth, wood floors which can be kept clean, may be used in rooms where new containers and supplies and certain packaged finished products are stored.

(d) Lighting and ventilation. (1) Light shall be ample, natural or artificial, or both, of good quality and well distributed. All rooms in which dairy products are manufactured or packaged or where utensils are washed shall have at least 30 foot-candles of light intensity on all working surfaces. Rooms where dairy products are graded or examined for condition and quality shall have at least 50 foot-candles of light intensity on the working surface. Restrooms and locker rooms should have at least 30 foot-candles of light intensity. In all other rooms there shall be provided at least 5 foot-candles of light intensity when measured at a distance of 30 inches from the floor. Where contamination of product by broken glass is possible, light bulbs and fluorescent tubes shall be protected against breakage.

(2) There shall be adequate heating, ventilation or air conditioning for all

rooms and compartments to permit maintenance of sanitary conditions. Exhaust or inlet fans, vents, hoods or temperature and humidity control equipment shall be provided where and when needed, to minimize or control room temperatures, eliminate objectionable odors, and aid in prevention of moisture condensation and mold. Inlet fans should be provided with an adequate air filtering device to eliminate dirt and dust from the incoming air. Ventilation systems shall be cleaned periodically as needed and maintained in good repair. Exhaust outlets shall be screened or provided with self closing louvers to prevent the entrance of insects when not in use. (e) Rooms and compartments. Rooms and compartments in which any raw material, packaging, ingredient supplies or dairy products are handled, manufactured, packaged or stored shall be so designed, constructed and maintained as to assure desirable room temperatures and clean and orderly operating conditions free from objectionable odors and vapors. Enclosed bulk milk receiving rooms, when present, shall be separated from the processing rooms by a wall. Rooms for receiving can milk shall be separated from the processing rooms by a partition or by suitable arrangement of equipment. Processing rooms shall be kept free from equipment and materials not regularly used.

(1) Coolers and freezers. Coolers and freezers where dairy products are stored shall be clean, reasonably dry and maintained at the proper uniform temperature and humidity to adequately protect the product, and minimize the growth of mold. Adequate circulation of air shall be maintained at all times. They shall be free from rodents, insects, and pests. Shelves shall be kept clean and dry. Refrigeration units shall have provisions for collecting and disposing of condensate.

(2) Supply room. The supply rooms or areas used for the storing of packaging materials; containers, and miscellaneous ingredients shall be kept clean, dry, orderly, free from insects, rodents, and mold, and maintained in good repair. Such items stored therein shall be adequately protected from dust, dirt, or other extraneous material and so arranged on racks, shelves or pallets to permit access to the supplies and cleaning and inspection of the room. Insecticides, rodenticides, cleaning compounds and other nonfood products shall be

properly labeled and segregated, and stored in a separate room or cabinet away from milk, dairy products, ingredients or packaging supplies.

(3) Boiler rooms, shop rooms and shop areas. The boiler, and shop rooms shall be separated from other rooms where milk, and dairy products are processed, manufactured, packaged, handled or stored. Shop rooms or areas should be kept orderly and reasonably free from dust and dirt.

(4) Toilet and dressing rooms. Adequate toilet and dressing room facilities shall be conveniently located.—(a) Toilet rooms shall not open directly into any room in which milk or dairy products are processed, manufactured, packaged or stored; doors shall be self closing; ventilation shall be provided by mechanical means to the outer air; fixtures shall be kept clean and in good repair. (b) All employees shall be furnished with a locker or other suitable facility and the lockers and dressing rooms shall be kept clean and orderly. Adequate handwashing facilities shall be provided. Legible signs shall be posted conspicuously in each toilet or dressing room directing employees to wash their hands before returning to work.

(5) Laboratory. (i) Consistent with the size and type of plant and the volume of dairy products manufactured, an adequately equipped laboratory shall be maintained and properly staffed with qualified and trained personnel for quality control and analytical testing. The laboratory should be located reasonably close to the processing activity and be of sufficient size to perform tests necessary in evaluating the quality of raw and finished products.

(ii) Approved laboratories shall be supervised by the USDA resident inspector in all aspects of official testing and reporting results. Plant laboratory personnel in such plants may be licensed by the USDA to perform official duties.

(iii) An approved central control laboratory serving more than one plant may be acceptable, if conveniently located to the dairy plants, and if samples and results can be transmitted without undue delay.

(6) Starter facilities. Adequate facilities shall be provided for the handling of starter cultures. The facilities shall not be located near areas where contamination is likely to occur.

(7) Grading and inspection room. When grading or inspection of product

is performed the plants shall furnish a room or designated area specifically for this purpose. The room or area shall be suitably located, sufficient in size, well lighted (see 58.126d), ventilated and the temperature shall be not less than 60° F. It shall be kept clean and dry, free from foreign odors and reasonably free from disturbing elements which would interfere with proper concentration by the grader or inspector. The grading or inspection room or area shall be equipped with a table or desk and convenient facilities for washing hands.

(8) Resident inspector's facilities. In resident plants, an office or space shall be provided for official purposes. The room or space should be conveniently located in or near the approved laboratory, adequate in size, and equipped with desk and a lockable storage supply cabinet, and clothes locker. It shall be well lighted, ventilated or air conditioned, and heated. Custodial service shall be furnished on a regular basis.

(9) Lunch rooms and eating areas. When these areas are provided, they (a) shall be kept clean and orderly, (b) should not open directly into any room in which milk or dairy products are processed, manufactured or packaged, and (c) signs shall be posted directing employees to wash their hands before returning to work.

§ 58.127 Facilities.

(a) Water supply. There shall be an ample supply of both hot and cold water of safe and sanitary quality, with adequate facilities for its proper distribution throughout the plant, and protected against contamination. Water from other facilities, when officially approved, may be used for boiler feed water and condenser water provided that such water lines are completely separated from the water lines carrying the sanitary water supply, and the equipment is so constructed and controlled as to preclude contamination of product contact surfaces. There shall be no cross connection between potable water lines and non-potable water lines or between public and private water supplies. Bacteriological examinations shall be made of the plant's sanitary water supply taken at the plant at least twice a year, or as often as necessary to determine safety and suitability as related to product keeping quality for use in manufacucts keeping quality for use in manube made by a USDA or State agency

laboratory except for supplies that are regularly tested for purity and bacteriological quality, and approved by the local health officer. The results of all water tests shall be kept on file at the plant for which the test was performed.

The location, construction, and operation of any well shall comply with regulations of the appropriate agency.

(b) Drinking-water facilities. Drinking-water facilities of a sanitary type shall be provided in the plant and should be conveniently located.

(c) Hand-washing facilities. Convenient hand-washing facilities shall be provided, including hot and cold running water, soap or other detergents, and sanitary single service towels or air driers. Such accommodations shall be located in or adjacent to toilet and dressing rooms and also at such other places in the plant as may be essential to the cleanliness of al personnel handling products. Vats for washing equipment or utensils shall not be used as hand-washing facilities. Containers shall be provided for used towels and other wastes. The containers may be metal or plastic, disposable or reuseable and should have self-closing covers.

(d) Steam. Steam shall be supplied in sufficient volume and pressure for satisfactory operation of each applicable piece of equipment. Culinary steam used in direct contact with milk or dairy products shall be free from harmful substances or extraneous material and only those boiler water additives which meet the requirements of 21 CFR 121.1088 shall be used, or a secondary steam generator shall be used in which soft water is converted to steam and no boiler compounds are used. Steam traps, strainers and condensate traps shall be used wherever applicable to insure a satisfactory and safe steam supply. Culinary steam shall comply with the recommended practices for "Producing Culinary Steam for Processing Milk and Milk Products" as published by the National Association of Food and Dairy Equipment Manufacturers, Washington, D.C., April 1963 or latest revision thereof.

(e) Air under pressure. The method for supplying air under pressure, which comes in contact with milk or dairy products or any product contact surface shall comply with the 3-A Accepted Practices for Supplying Air Under Pres

sure.

(f) Disposal of wastes. Dairy wastes shall be Properly disposed of from the