[41 Pa.B. 2540]
[Saturday, May 21, 2011]
[Continued from previous Web Page]
Subchapter D. FARMS PRODUCING MILK FOR MANUFACTURING Sec.
59a.201. Farm inspection. 59a.202. Milking facilities and housing. 59a.203. Milking procedures. 59a.204. Cooling and storage. 59a.205. Milkhouse or milkroom. 59a.206. Utensils and equipment. 59a.207. Water supply. 59a.208. Sewage disposal. § 59a.201. Farm inspection.
Farms producing and selling milk for manufacturing purposes shall comply with the following inspection provisions:
(1) Each dairy farm operated by a producer of milk for manufacturing purposes shall be inspected initially and on any change of market by an approved inspector and shall have a passing score before the first milk is shipped. To attain a passing score, there may not be deficiencies in areas of major significance to the sanitary quality of the farm's milk supply unless these deficiencies are immediately corrected during the inspection. These areas of major significance include toilet, water supply, construction of utensils and equipment, cleaning and sanitizing of equipment, cow cleanliness and proper storage and labeling of medications. Dairy farms producing milk for manufacturing purposes shall be inspected every 6 months by an approved inspector, and an accurate record of inspections shall be maintained by each permitholder for 24 months.
(2) Producers who cannot produce milk of a wholesome sanitary quality will be suspended. Producers who are not in substantial compliance with this section or § 59a.102 (relating to milk permits) will be reinspected after an appropriate time for correction of deficiencies. Milk for manufacturing is of wholesome sanitary quality if it meets the applicable requirements of Subchapter C (relating to production and processing of milk for manufacturing purposes), including those relating to appearance and odor, drug residue, sediment content, bacterial estimate and somatic cell count, and § 59a.202 (relating to milking facilities and housing).
(3) A permitholder shall promptly notify the Department of initial instatement, suspension or reinstatement of a producer from which milk for manufacturing is or was received. Identification of the producer, including name and address, shall be provided orally or by mail within 24 hours of the action.
§ 59a.202. Milking facilities and housing.
(a) General requirements. A milking barn or milking parlor of adequate size and arrangement shall be provided to permit normal sanitary milking operations. It shall be well lighted and ventilated, and the floors and gutters in the milking area shall be constructed of concrete or other impervious material. The facility shall be kept clean, the manure removed daily and stored to prevent access of lactating animals to accumulation thereof. Swine or fowl may not be permitted in the milking area. When a milking barn is used and horses are present, the horses shall be stalled in a separate area a sufficient distance from the milking area or separated by tight partitions.
(b) Platforms and ramps. If a milking barn or milking parlor has ramps and platforms that are used to elevate lactating animals, these ramps and platforms must be constructed of an impervious material such as steel. Wooden platforms and ramps are prohibited. Rubber mats may be used as long as they are not placed over a wooden platform.
(c) Concentrates and feed storage. Concentrates and feed, if stored in the building, shall be stored in a tightly covered box, bin or container.
(d) Protection of exposed milk. If milk is exposed during straining or transferring in the milking area, it shall be protected from falling particles from areas above the milk facility.
(e) Yard requirements. The yard or loafing area must be of ample size to prevent overcrowding, be drained to prevent forming of standing water pools, insofar as practicable, and kept clean.
§ 59a.203. Milking procedures.
(a) Cleanliness of udders and flanks. The udders and flanks of all lactating animals shall be kept clean. The udders and teats shall be washed or wiped immediately before milking with a clean, damp cloth or paper towel moistened with a sanitizing solution and wiped dry or by another sanitary method approved in writing by the Department.
(b) Milker. The milker's outer clothing must be clean and his hands clean and dry. A person with an infected cut or open sores on the person's hands or arms may not milk lactating animals, or handle milk or milk containers, utensils or equipment.
(c) Equipment. Milk stools, surcingles or antikickers shall be kept clean and properly stored. Dusty operations may not be conducted immediately before or during milking. Strong flavored feeds may not be fed immediately before or during milking.
(d) Abnormal milk. In addition to the requirements of § 59a.116 (relating to abnormal milk), abnormal milk may not be squirted on the floor, on the platform or in the producer's hand. Producers shall also wash their hands after handling equipment and handling the teats and udders of animals producing abnormal milk.
§ 59a.204. Cooling and storage.
(a) Milk in cans. Milk in cans shall be cooled immediately after milking to 50° F or lower at the farm, and not exceed 55° F upon delivery to the plant, unless delivered to the plant within 2 hours after milking. The cooler, tank or refrigerated unit shall be kept clean. Maximum time of delivery of milk to a milk plant shall be within 48 hours of initial milking.
(b) Milk in farm bulk tanks. Milk in farm bulk tanks shall be cooled to 40° F within 2 hours after milking. Cooled milk may not be allowed to rise above a temperature of 50° F by subsequent addition of milk to the bulk tank and shall be cooled at 45° F or lower at time of pick-up, and not exceed 50° F upon delivery to the plant. Maximum time of delivery of milk to a milk plant may not exceed 72 hours of initial milking.
§ 59a.205. Milkhouse or milkroom.
(a) General requirements. A milkhouse or milkroom shall be provided for handling and cooling milk and for washing, handling and storing the utensils and equipment. The milkhouse or milkroom must be conveniently located and properly constructed, lighted and ventilated. Other products may not be handled in the milkroom which would be likely to contaminate milk, or otherwise create a public health hazard.
(b) Equipment and construction. The milkroom must be equipped with a wash and rinse vat, utensil rack, milk cooling facilities and an adequate supply of hot water available for cleaning milking equipment. If a part of the barn or other building, it must be partitioned, screened and sealed to prevent the entrance of dust, flies or other contamination. The floor of the building must be of concrete or other impervious material and graded to provide proper drainage. The walls and ceilings must be constructed of smooth easily cleaned material. Outside doors must open outward and be self-closing, unless they are provided with tight-fitting screen doors that open outward or unless other effective means are provided to prevent the entrance of flies.
(c) Farm bulk tanks. If a farm bulk tank is used, the following requirements apply:
(1) The farm bulk tank shall be properly located in the milkhouse or milkroom for access to all areas for cleaning and servicing. It may not be located over a floor drain or under a ventilator.
(2) A small platform or slab constructed of concrete or other impervious material shall be provided outside the milkhouse, properly centered under a suitable port opening in the wall of the milkhouse. The opening shall be fitted with a tight, self-closing door. The truck approach to the milkhouse or milkroom must be properly graded and surfaced to prevent mud or pooling of water at the point of loading.
(d) Trash, animals and fowl. The milkhouse or milkroom and appurtenances shall be kept clean and free of trash, animals and fowl.
(e) Farm chemicals and animal drugs.
(1) Animal biologics and other drugs intended for treatment of animals, and insecticides approved for use in dairy operations, must be clearly labeled and used in accordance with label instructions, and stored in a manner which will prevent accidental contact with milk and milk contact surfaces.
(2) Only drugs that are approved by the FDA or biologics approved by the United States Department of Agriculture (USDA) for use in dairy animals that are properly labeled according to FDA or USDA regulations shall be administered to the animals.
(3) When drug storage is located in the milkroom, milkhouse or milking area, the drugs shall be stored in a closed, tight-fitting storage unit. The drugs shall further be segregated so that drugs labeled for use in lactating dairy animals are separated from drugs labeled for use in nonlactating dairy animals.
(4) Drugs labeled for use in nondairy animals may not be stored with drugs labeled for use in dairy animals. When drugs labeled for use in nondairy animals are stored in the barn, the drugs shall be located in an area of the barn separate from the milking area.
(5) Herbicides, fertilizers, pesticides and insecticides that are not approved for use in dairy operations may not be stored in the milkhouse, milkroom or milking area.
§ 59a.206. Utensils and equipment.
(a) General requirements. Utensils, milk cans, milking machines—including pipeline systems—rubber and rubber-like parts and other equipment used in the handling of milk shall be maintained in good condition, be free from rust, open seams, milkstone or any unsanitary condition, and shall be washed, rinsed and drained after each milking, stored in suitable facilities and sanitized immediately before use with a dairy equipment sanitizer that has been approved by the United States Environmental Protection Agency for use with dairy or food processing equipment, and that is used according to the label directions. New or replacement can lids must be umbrella type. New utensils and equipment must comply with applicable 3-A Sanitary Standards.
(b) Farm bulk tanks. Farm bulk tanks must meet 3-A Sanitary Standards for construction at the time of installation and be installed under § 59a.26 (relating to plans for construction and reconstruction).
(c) Single service articles. Single service articles shall be properly stored and may not be reused.
§ 59a.207. Water supply.
A dairy farm water supply shall be properly located, protected and operated, and shall be easily accessible, ample, and of safe, sanitary quality for the cleaning of dairy utensils and equipment. The water supply must come from a source which complies with the water supply provisions of the Grade ''A'' PMO, including Appendix D, regarding standards for water sources, and is approved by the Department.
§ 59a.208. Sewage disposal.
House, milkhouse or milkroom and toilet wastes shall be disposed of in a manner that does not pollute the soil surface, contaminate the water supply or be conducive to the breeding of insects.
Subchapter E. MANUFACTURING PLANTS
GENERAL REQUIREMENTS Sec.
59a.301. Premises. 59a.302. Buildings. 59a.303. Facilities. 59a.304. Equipment and utensils. 59a.305. Personnel cleanliness. 59a.306. Personnel health. 59a.307. Protection and transport of raw milk and cream. 59a.308. Raw product storage. 59a.309. Pasteurized, ultrapasteurized or aseptically processed and packaged products. 59a.310. Composition and wholesomeness. 59a.311. Cleaning and sanitizing treatment. 59a.312. Insect and rodent control program. 59a.313. Plant records. 59a.314. Packaging and general identification. 59a.315. Storage of finished product. 59a.316. Permits.
SUPPLEMENTAL REQUIREMENTS FOR PLANTS MANUFACTURING, PROCESSING AND PACKAGING INSTANT NONFAT DRY MILK, NONFAT DRY MILK, DRY WHOLE MILK, DRY BUTTERMILK, DRY WHEY AND OTHER DRY MILK PRODUCTS
59a.321. Requirements for rooms and compartments. 59a.322. Dry storage. 59a.323. Packaging room for bulk products. 59a.324. Hopper or dump room. 59a.325. Repackaging room. 59a.326. Equipment and utensils. 59a.327. Preheaters. 59a.328. Hotwells. 59a.329. Evaporators or vacuum pans, or both. 59a.330. Surge tanks. 59a.331. High pressure pumps and lines. 59a.332. Dryers. 59a.333. Collectors and conveyors. 59a.334. Dry dairy product cooling equipment. 59a.335. Special treatment equipment. 59a.336. Sifters. 59a.337. Portable and stationary bulk bins. 59a.338. Automatic sampling device. 59a.339. Dump hoppers, screens and mixers. 59a.340. Filler and packaging equipment. 59a.341. Heavy duty vacuum cleaners. 59a.342. Clothing and shoe covers. 59a.343. Operations and operating procedures: Pasteurization. 59a.344. Operations and operating procedures: Condensed surge supply. 59a.345. Operations and operating procedures: Condensed storage tanks. 59a.346. Operations and operating procedures: Drying. 59a.347. Operations and operating procedures: Cooling dry products. 59a.348. Operations and operating procedures: Packaging, repackaging and storage. 59a.349. Operations and operating procedures: Product adulteration. 59a.350. Operations and operating procedures: Checking quality. 59a.351. Operations and operating procedures: Requirements for instant nonfat dry milk. 59a.352. Operations and operating procedures: Cleaning of dryers, conveyors, sifters and storage bins. 59a.353. Operations and operating procedures: Insect and rodent control program.
SUPPLEMENTAL REQUIREMENTS FOR PLANTS MANUFACTURING, PROCESSING AND PACKAGING BUTTER AND RELATED PRODUCTS
59a.361. Rooms and compartments. 59a.362. Equipment and utensils. 59a.363. Operations and operating procedures.
SUPPLEMENTAL REQUIREMENTS FOR PLANTS MANUFACTURING AND PACKAGING CHEESE
59a.371. Rooms and compartments. 59a.372. Equipment and utensils. 59a.373. Operations and operating procedures.
SUPPLEMENTAL REQUIREMENTS FOR PLANTS MANUFACTURING, PROCESSING AND PACKAGING PASTEURIZED PROCESS CHEESE AND RELATED PRODUCTS
59a.381. Equipment and utensils. 59a.382. Operations and operating procedures.
SUPPLEMENTAL REQUIREMENTS FOR PLANTS MANUFACTURING, PROCESSING AND PACKAGING EVAPORATED, CONDENSED OR STERILIZED MILK PRODUCTS
59a.391. Equipment and utensils. 59a.392. Operations and operating procedures.
GENERAL REQUIREMENTS § 59a.301. Premises.
(a) General. The exterior premises of a manufacturing plant shall be kept in a clean and orderly condition, and be free from strong or foul odors, smoke or excessive air pollution. Construction and maintenance of driveways and adjacent plant traffic areas must be of concrete, asphalt or similar material to keep dust and mud to a minimum.
(b) Surroundings. The adjacent surroundings of a manufacturing plant must be free from refuse, rubbish 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 manufacturing plant buildings and driveways, including surface water around the plant and on the premises. The water shall be disposed of in a manner that prevents a nuisance or health hazard.
§ 59a.302. Buildings.
(a) General. Manufacturing plant buildings must be of sound construction and kept in good repair to prevent the entrance or harboring of rodents, birds, insects, vermin, dogs and cats. Service pipe openings through outside walls shall be effectively sealed around the opening or provided with tight metal collars.
(b) Outside doors, windows and openings. 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. Outside doors opening into processing rooms must be in good condition and fit properly. Hinged, outside screen doors must open outward. Doors and windows shall 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 a 45° angle.
(c) Walls, ceilings, partitions and posts. The walls, ceilings, partitions, 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, must be smoothly finished with a suitable material of light color, which is substantially impervious to moisture and kept clean. They shall be refined as often as necessary to maintain a neat, clean surface.
(d) Floors.
(1) The floors of all rooms in which milk or dairy products are processed, manufactured, packaged or stored or in which utensils are washed must be constructed of tile properly laid with impervious joint material, concrete or other equally impervious material. The floors must be smooth, kept in good repair, graded so that there will be no pools of standing water or milk products after flushing, and the openings to the drains must be equipped with traps properly constructed and kept in good repair. On new construction, bell-type traps may not be used. The plumbing shall be installed to prevent the backup of sewage into the drain lines and to the floor of the plant.
(2) 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.
(e) Lighting and ventilation. Lighting and ventilation must comply with the following:
(1) Light must be ample, natural or artificial, or both, of good quality and well distributed. Rooms in which dairy products are manufactured or packaged or where utensils are washed must have at least 30 foot-candles of light intensity on all working surfaces and at least 50 foot-candles of light intensity in areas where dairy products are graded or examined for condition and quality. In other rooms, there must be at least 5 foot-candles of light intensity when measured at a distance of 30 inches from the floor. Where contamination of a product by broken glass is possible, light bulbs, fluorescent tubes, fixtures, skylight or other glass suspended over the product must be protected against breakage.
(2) There must 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 facilities shall be provided where and when needed to minimize or eliminate undesirable room temperatures, objectionable odors, moisture condensation or mold. Inlet fans shall 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 must be screened or provided with self-closing louvers to prevent the entrance of insects when not in use.
(f) Certain rooms and compartments. Rooms and compartments in which raw material, packaging, ingredient supplies or dairy products are handled, manufactured, packaged or stored shall be designed, constructed and maintained to assure desirable room temperatures and clean and orderly operating conditions free from objectionable odors and vapors. Enclosed bulk milk receiving rooms must be separated from the processing rooms by a partition. Rooms for receiving can milk must be separated from the processing rooms by a partition—partial or complete—by suitable arrangement of equipment or by allowing enough distance between receiving and processing operations to avoid possible contamination of milk or dairy products during manufacturing and handling. Processing rooms shall be kept free from equipment and materials not regularly used. Rooms and compartments must comply with the following:
(1) Coolers and freezers. Coolers and freezers where dairy products are stored must 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 must be maintained at all times. Coolers and freezers must be free from rodents, insects and pests. Shelves shall be kept clean and dry. Refrigeration units must have provisions for collecting and disposing of condensate.
(2) Supply room. The supply rooms 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. Items stored in supply rooms shall be adequately protected from dust, dirt or other extraneous matter and 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 must 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 room and service areas. The boiler rooms, shop room and service areas must be separated from other rooms where milk and dairy products are processed, manufactured, packaged, handled or stored. The rooms shall be kept orderly and reasonably free from dust and dirt.
(4) Toilet and dressing rooms. Adequate toilet and dressing rooms facilities must be conveniently located.
(i) Toilet rooms may not open directly into a room where milk or dairy products are processed, manufactured, packaged or stored. Doors must be self-closing. Ventilation must be provided by mechanical means or screened openings to the outer air. Fixtures shall be kept clean and in good repair.
(ii) 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 and durable, legible signs shall be posted conspicuously in each toilet or dressing room directing employees to wash their hands before returning to work.
(5) Laboratory. The permitholder may establish its own laboratory to perform required tests on milk received as milk for manufacturing purposes. The laboratory shall be adequately equipped and maintained and be properly staffed with qualified, trained personnel and operate in accordance with the current Evaluation of Milk Laboratories, Recommendations of the United States Public Health Service/Food and Drug Administration and current FDA 2400 Laboratory Series forms. If the permitholder does not establish its own laboratory, an existing approved laboratory is acceptable if services are conveniently available so that samples and results can be transmitted without delay.
(6) Starter facilities. Adequate sanitary facilities shall be provided for the handling of starter cultures.
(7) Lunch rooms and eating areas. When eating areas are provided, they shall be kept clean and orderly and not open directly into a room in which milk or dairy products are processed, manufactured or packaged. Signs shall be posted directing employees to wash their hands before returning to work.
§ 59a.303. Facilities.
(a) Water supply. There must 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 protection against contamination and pollution. Water from other facilities, when approved in writing by the Department, may be used for boiler feed water and condenser water provided that the waterlines are completely separated from the waterlines carrying the sanitary water supply, and the equipment is so constructed and controlled to preclude contamination of product contact surfaces. There may not be cross connection between the safe water supply and any unsafe or questionable water supply, or any other source of pollution through which contamination of the safe water supply is possible. Bacteriological examination shall be made of the sanitary water supply at least twice a year, or as often as necessary to determine purity and suitability for use in manufacturing dairy products. The tests shall be made in a laboratory that is approved by the Department. The results of all water tests shall be kept on file at the plant for which the test was performed.
(b) Drinking water. Sanitary drinking water facilities shall be provided in the plant and 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 dryers. The accommodations must be located in or adjacent to toilet and dressing rooms and also at other places in the plant that may be essential to the cleanliness of all personnel handling products. Vats for washing equipment or utensils may not be used as handwashing facilities. Self-closing metal or plastic containers shall be provided for used towels and other wastes.
(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 must be free from harmful substances or extraneous material and only nontoxic boiler compounds 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 must comply with the current 3-A Accepted Practices for a Method of Producing Culinary Steam.
(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 must comply with the current 3-A Accepted Practices for Supplying Air Under Pressure. The air used at the point of application must be free from volatile substances, volatiles which may impart any flavor or odor to the products, and extraneous or harmful substances.
(f) Dairy waste. Dairy wastes shall be properly disposed of from the plant and premises. The sewer system must have sufficient slope and capacity to readily remove all waste from the various processing operations. When a public sewer is not available, wastes shall be properly disposed of so as not to contaminate milk equipment or to create a nuisance or public health hazard. Containers used for the collection and holding of wastes shall be constructed of metal, plastic or other equally impervious material and kept covered with tight fitting lids and placed outside the plant on a concrete slab or on a rack raised at least 12 inches. Waste containers may be kept inside a suitably enclosed, clean and flyproof room. Solid wastes shall be disposed of regularly and the containers cleaned before reuse. Accumulation of dry wastepaper and cardboard shall be kept to a minimum.
§ 59a.304. Equipment and utensils.
(a) General construction, repair and installation.
(1) The equipment and utensils used for the processing of milk and manufacture of dairy products must be constructed to be readily demountable when necessary for cleaning and sanitizing. The product contact surfaces of all utensils and equipment such as holding tanks, pasteurizers, coolers, vats, agitators, pumps, sanitary piping and fittings or any specialized equipment must be constructed of stainless steel or other equally corrosion-resistant material. Nonmetallic parts other than glass having product contact surfaces must meet the current 3-A Standards for Multiple-Use Plastic Materials or the current 3-A Sanitary Standards for Multiple-Use Rubber, and Rubber-Like Materials Used as Product Contact Surfaces in Dairy Equipment.
(2) Equipment and piping shall be designed and installed to be easily accessible for cleaning, and be kept in good repair, free from cracks and corroded surfaces. New or rearranged equipment must be set away from any wall or spaced in a manner that facilitates proper cleaning and good housekeeping. Parts or interior surfaces of equipment, pipes (except certain piping cleaned in place) or fittings, including valves and connections, must be accessible for inspection.
(3) CIP systems must comply with the current 3-A Sanitary Practices for Permanently Installed Sanitary Product, Pipelines, and Cleaning Systems Used in Milk and Milk Processing Plants.
(b) Weigh cans and receiving tanks. Weigh cans and receiving tanks must meet the general requirements of this section, be easily accessible for cleaning both inside and outside and elevated above the floor and protected sufficiently with the necessary covers or baffles to prevent contamination from splash, condensate and drippage. When necessary to provide easy access for cleaning of floors and adjacent wall areas, the receiving tank must be equipped with wheels or casters to allow easy removal.
(c) Can washers. Can washers must have sufficient capacity and ability to discharge a clean, dry can and cover and shall be kept properly timed in accordance with the instructions of the manufacturer. The water and steam lines supplying the washer must maintain a reasonably uniform pressure and if necessary be equipped with pressure regulating valves.
(d) Product storage tanks or vats. Storage tanks or vats must be fully enclosed or tightly covered and well insulated. The entire interior surface, agitator and all appurtenances must be accessible for thorough cleaning and inspection. Any opening at the top of the tank or vat including the entrance of the shaft must be suitably protected against the entrance of dust, moisture, insects, oil or grease. The sight glasses, if used, must be sound, clean and in good repair. Vats which have hinged covers must be designed so that moisture or dust on the surface cannot enter the vat when the covers are raised. If the storage tanks or vats are equipped with air agitation, the system must be of an approved type and properly installed in accordance with the current 3-A Accepted Practices for Supplying Air Under Pressure. Storage tanks or vats intended to hold product for longer than approximately 8 hours must be equipped with adequate refrigeration or have adequate insulation, or both. New storage tanks or vats must meet the appropriate 3-A Sanitary Standards and be equipped with thermometers in good operating order.
(e) Separators. Product contact surfaces of separators must be free from rust and pits and insofar as practicable be of stainless steel or other equally noncorrosive metals. New separators must meet the current 3-A Sanitary Standards for Centrifugal Separators and Clarifiers.
(f) Coil or dome-type batch pasteurizers. Coil or dome-type batch pasteurizers must be stainless steel lined and if the coil is not stainless steel or other equally noncorrosive metal it must be properly tinned over the entire surface. Sanitary seal assemblies at the shaft ends of coil vats must be of the removable type, except that existing equipment not provided with this type gland will be acceptable if the packing glands are maintained and operated without adverse effects. New or replacement units must be provided with removable packing glands. Dome-type pasteurizer agitators must be stainless steel except that any nonmetallic parts must meet the current 3-A Sanitary Standards for Plastic and Rubber or Rubber-Like Materials, as applicable. Each pasteurizer used for heating product at 165° F or lower for 30 minutes or less must be equipped with space heating equipment and the necessary thermometers to insure a temperature at least 5° F above that required for pasteurization of the product. There must be adequate means of controlling the temperature of the heating medium. Batch pasteurizers must have temperature indicating and recording devices, and meet the current 3-A Sanitary Standards for Non-Coil Type Batch Pasteurizers.
(g) HTST pasteurizers. When pasteurization is intended or required, an approved timing pump or device recorder-controller, automatic flow diversion valve and holding tube or its equivalent, if not a part of the existing equipment, shall be installed on all HTST equipment used for pasteurization, to assure complete pasteurization. The entire facility must meet the current 3-A Accepted Practices for the Sanitary Construction, Installation, Testing, and Operation of High-Temperature, Short-Time Pasteurizers. After the HTST unit has been tested according to the 3-A Accepted Practices, the timing pump or device and the recorder controller shall be sealed at the correct setting to assure pasteurization. Sealing of the HTST unit shall be performed by the control authority having jurisdiction. The HTST pasteurizer shall be tested initially upon installation, and whenever any alteration or replacement is made which affects the proper operation of the instrument or device. When direct steam pasteurizers are used, the steam, prior to entering the product, must be conducted through a steam strainer and a steam purifier equipped with a steam trap and only steam meeting the requirements for culinary steam shall be used.
(h) Indicating thermometers.
(1) Long-stem indicating thermometers which are accurate within 0.5° F, plus or minus, for the applicable temperature range, shall be provided for checking the temperature of pasteurization and cooling of products in vats and checking the accuracy of recording thermometers.
(2) Short-stem indicating thermometers, which are accurate within 0.5° F, plus or minus, for the applicable temperature range, shall be installed in the proper stationary position in all HTST and dome-type pasteurizers. Storage tanks where temperature readings are required must have thermometers which are accurate within 2.0° F, plus or minus.
(3) Air-space indicating thermometers, when applicable, which are accurate within 1.0° F, plus or minus, for the proper temperature range shall also be installed above the surface of the products pasteurized in vats, to make certain that the temperature of the foam or air above the products pasteurized, or both, also received the required minimum temperature treatment.
(i) Recording thermometers.
(1) HTST recording thermometers that are accurate within 1° F, plus or minus, for the applicable temperature range, shall be used on each heat treating, pasteurizing or sterilizing unit to record the heating process.
(2) Additional use of recording thermometers accurate within 2° F, plus or minus, may be required where a record of temperature or time of cooling and holding is of significant importance. A record of temperature or time of cooling and holding is of significant importance when made in accordance with §§ 59a.328, 59a.344, 59a.373(b), 59a.381(d), 59a.382(b) and 59a.392(b)(1).
(j) Surface coolers. Surface coolers must be equipped with hinged or removable covers for the protection of the product. The edges of the fins must be designed to divert condensate on nonproduct contact surfaces away from product contact surfaces. Gaskets or swivel connections must be leak proof.
(k) Plate-type heat exchangers. Plate-type heat exchangers must meet the current 3-A Sanitary Standards for Construction and Installation. Gaskets must be tight and kept in good operating order. Plates shall be opened for inspection by the operator at sufficiently frequent intervals to determine if the equipment is clean and in satisfactory condition. A cleaning regimen shall be posted to insure proper cleaning procedures between inspection periods.
(l) Internal return tubular heat exchangers. Internal return tubular heat exchangers must meet the current 3-A Sanitary Standards for Construction and Installation.
(m) Pumps. Pumps used for milk and dairy products must be of the sanitary type and constructed to meet 3-A Sanitary Standards. Unless pumps are specifically designed for effective cleaning in place, they shall be disassembled and thoroughly cleaned after use.
(n) Homogenizers. Homogenizers and high pressure pumps of the plunger type must meet the 3-A Sanitary Standards.
(o) New equipment and replacements. New equipment and replacements, including all plastic parts and rubber and rubber-like materials for parts and gaskets having product contact surfaces, must meet the current 3-A Sanitary Standards or 3-A Accepted Practices. If 3-A Sanitary Standards or 3-A Accepted Practices are not available, the equipment and replacements must meet the general requirements of this section.
(p) Certain vacuum chambers. A vacuum chamber, as used for flavor control, must be made of stainless steel or other equally noncorrosive metal. The unit must be constructed to facilitate cleaning and product contact surfaces must be accessible for inspection. The chamber must be equipped with a vacuum breaker and a check valve at the product discharge line. Only steam which meets the requirements for culinary steam may be used. The incoming steam supply shall be regulated by an automatic solenoid valve which will cut off the steam supply in the event the flow diversion valve of the HTST pasteurizer is not in the forward flow position. Condensers when used must be equipped with a water level control and an automatic safety shutoff valve.
§ 59a.305. Personnel cleanliness.
Employees shall wash their hands before beginning work and upon returning to work after using toilet facilities, eating, smoking or otherwise soiling their hands. Employees shall keep their hands clean and follow good hygienic practices while on duty. Expectorating or use of tobacco in any form shall be prohibited in each room and compartment where any milk, dairy product or supplies are prepared, stored or otherwise handled. Clean white or light-colored washable outer garments, hair nets and adequate hair covering shall be worn by all persons engaged in receiving, testing, processing milk, manufacturing, packaging or handling dairy products.
§ 59a.306. Personnel health.
A person affected with any disease in a communicable form or while a carrier of the disease may not be permitted in any room or compartment where milk and dairy products are prepared, manufactured or otherwise handled. A person who has a discharging or infected wound, sore or lesion on hands, arms or other exposed portion of the body may not work in any dairy processing rooms or in any capacity resulting in contact with milk or dairy products. Each employee whose work brings him in contact with the processing or handling of dairy products, containers or equipment shall have a medical and physical examination by a registered physician or by the local department of health at the time of employment. In addition, an employee returning to work following illness from a communicable disease shall have a certificate from the attending physician to establish proof of complete recovery. Medical certificates attesting the fact that the employee when last examined was free from communicable disease shall be kept on file at the plant office.
§ 59a.307. Protection and transport of raw milk and cream.
(a) Equipment and facilities.
(1) Milk cans. Cans used in transporting milk from dairy farm to plant must be constructed to be easily cleaned, and shall be inspected, repaired and replaced as necessary to exclude substantially the use of cans and lids with open seams, cracks, rust, milkstone or any unsanitary condition.
(2) Farm bulk tanks. New farm bulk tanks must meet current 3-A Sanitary Standards for construction and be installed in accordance with the requirements of the Grade ''A'' PMO.
(b) Transporting milk or cream.
(1) Vehicles. Vehicles used for the transportation of can milk or cream must be of the enclosed type, constructed and operated to protect the product from extreme temperature, dust or other adverse conditions and kept clean. Decking boards or racks shall be provided when more than one tier of cans is carried. Cans, or bulk tanks on vehicles, used for the transportation of milk from the farm to the plant may not be used for any other purpose.
(2) Transport tanks. The exterior shell of transport tanks must be clean and free from open seams or cracks which would permit liquid to enter the jacket. The interior shell must be stainless steel and constructed so it will not buckle, sag or prevent complete drainage. Product contact surfaces must be smooth, easily cleaned and maintained in good repair. The pump and hose cabinet must be fully enclosed with tight fitting doors and the inlet and outlet must be provided with dust covers to give adequate protection from road dust. New and replacement transport tanks must meet the current 3-A Sanitary Standards for Stainless Steel Automotive Transportation Tanks for Bulk Delivery and/or Farm Pick-Up Service.
(c) Cleaning and sanitizing facilities. Enclosed facilities shall be available for washing and sanitizing of transport tanks, piping and accessories, at central locations or at all plants that receive or ship milk or milk products in transport tanks.
(d) Transfer of milk. Milk shall be transferred under sanitary conditions from farm bulk tanks through stainless steel piping or approved tubing. The sanitary piping and tubing must be capped when not in use.
§ 59a.308. Raw product storage.
(a) General. Milk shall be held and processed under conditions and at temperatures that will avoid contamination and rapid deterioration. Drip milk from can washers or another source may not be used for the manufacture of dairy products. Bulk milk in storage tanks within the plant shall be handled to minimize bacterial increase and shall be maintained at 45° F or lower until processing begins. This does not preclude holding milk at higher temperatures for a period of time, when applicable to particular manufacturing or processing practices.
(b) Bacteriological quality. The bacteriological quality of commingled milk in storage tanks must be 1 million/ml or lower.
(c) Sampling. During any consecutive 6 months, at least four samples of commingled raw milk for processing will be taken by the Department, or a designated representative, from each plant. The designated representative shall be an approved sampler who is either an employee of the plant or an employee or representative of a Pennsylvania-approved dairy laboratory.
(d) Testing of samples. A laboratory test of the samples described in subsection (c) shall be performed at a Pennsylvania-approved dairy laboratory to determine the bacterial estimate.
(e) Procedures if bacterial counts are high. Whenever a bacterial estimate of commingled milk in a plant indicates the presence of more than 1 million per milliliter, the following procedures shall be applied:
(1) The Department will notify plant management with a warning of excessive bacterial estimate, and recommend that appropriate action be taken to eliminate the bacterial problem.
(2) Whenever two of the last four consecutive commingled milk bacterial estimates exceed 1 million per milliliter, the Department will notify plant management with a written warning notice. The notice will be in effect so long as two of the last four consecutive samples exceed 1 million per milliliter. Plant management should continue to work to eliminate the problem.
(3) An additional sample will be taken by the Department after a lapse of 3 days but within 21 days of the notice required in paragraph (1). If this sample also exceeds 1 million per milliliter, the Department may take action (such as permit suspension or acting to keep the milk from the market place) until an additional sample of commingled milk is tested and found satisfactory. A temporary status may be assigned to the plant by the Department when an additional sample of commingled milk is tested and found in conformance with the 1,000,000-per-milliliter or lower bacterial classification standard for commingled raw milk for manufacturing. The plant will be assigned a full reinstatement status when three out of four consecutive commingled bacterial estimates do not exceed 1 million per milliliter. The samples will be taken at a rate of not more than two per week on separate days within a 3-week period.
(4) If a plant remains in temporary status in excess of 60 days, administrative procedures to suspend the plant's license will be taken by the Department until the plant complies with the bacteriological requirements.
(f) Heat treated cream. Heat treated cream is derived from the heating of raw milk, one time, to temperatures greater than 125° F but less than 161° F for separation purposes. When enzyme deactivation is necessary for a functional reason, the cream may be further heated to less than 166° F in a continuing heating process. The resulting bulk shipment of cream shall be cooled to 45° F or less, and labeled as heat treated with bacterial limits of 20,000 per ml or gm for dairy products which are weighed.
§ 59a.309. Pasteurized, ultrapasteurized or aseptically processed and packaged products.
Pasteurized, ultrapasteurized or aseptically processed and packaged products must conform with § 59a.2 (relating to definitions). When pasteurization or sterilization is intended or required, or when a product is designated ''pasteurized'' or ''sterilized,'' every particle of the product shall be subjected to temperatures and holding periods that assure proper pasteurization or sterilization of the product. The heat treatment by either process must be sufficient to insure public health safety and to assure adequate keeping quality, yet retaining the most desirable flavor and body characteristics of the finished product. The phenol value of test samples of pasteurized finished product may be no greater than the maximum specified for the particular product as determined and specified by the phosphatase test method prescribed in the latest edition of ''Official Methods of Analysis of the Association of Official Agricultural Chemists'' (a publication of the Association of Official Analytical Chemists International, 481 North Frederick Avenue, Suite 500, Gaithersburg, MD 20877-2417).
§ 59a.310. Composition and wholesomeness.
Necessary precautions shall be taken to prevent contamination or adulteration of the milk or dairy products during manufacturing. Substances and ingredients used in the processing or manufacturing of a dairy product will be subject to inspection and must be wholesome and practically free from impurities. The finished product must comply with the Food, Drug, and Cosmetic Act (21 U.S.C.A. §§ 301—399a) and applicable Commonwealth statutes as to their composition and wholesomeness.
§ 59a.311. Cleaning and sanitizing treatment.
(a) Equipment and utensils.
(1) The equipment, sanitary piping and utensils used in receiving and processing of the milk, and manufacturing and handling of the product shall be maintained in a sanitary condition. Sanitary seal assemblies must be removable on all agitators, pumps and vats, and shall be inspected at regular intervals and kept clean. Unless other provisions are recommended in the following supplemental sections, equipment not designed for CIP cleaning shall be disassembled after each day of use for thorough cleaning. Cleaning and sanitizing chemicals that are utilized for this cleaning must be labeled and shall be used in accordance with label directions. Steel wool or metal sponges may not be used in the cleaning of any dairy equipment or utensils. Utensils and portable equipment used in processing and manufacturing operations shall be stored above the floor in clean, dry locations and in a self draining position on racks constructed of impervious corrosion resistant material. All product contact surfaces shall be subjected to an effective sanitizing treatment immediately prior to use, except when dry cleaning is permitted. This sanitizing treatment shall entail subjection of a clean surface to steam, hot water, hot air, or an acceptable sanitizing solution for the destruction of most human pathogens and other vegetative microorganisms to a level considered safe for product production, without adversely affecting the equipment, the milk, the milk product or the health of consumers. Sanitizing solutions must comply with 21 CFR 178.1010 (relating to sanitizing solutions).
(2) CIP cleaning, including sprayball systems, shall be used only on equipment and pipeline systems which have been designed and engineered for that purpose. When that cleaning is used, careful attention shall be given to the proper procedures to assure satisfactory cleaning. CIP installations and cleaning procedures shall be in accordance with the current 3-A Accepted Practices for Permanently Installed Product and Solution Pipelines and Cleaning Systems Used in Milk and Milk Product Processing Plants. The established cleaning procedure shall be posted and followed. Following the circulation of the cleaning solution, the equipment and lines shall be thoroughly rinsed and checked for effectiveness of cleaning. Caps, plugs, special fittings, valve seats, cross ends and tee ends shall be opened or removed and brushed clean. Immediately prior to starting the product flow, the product contact surfaces shall be properly sanitized.
(b) Milk cans and can washers. Milk cans and can washers must meet the following requirements:
(1) Milk cans and lids shall be cleaned, sanitized and dried before they are returned to producers. Inspection, repair or replacement of cans and lids shall be adequate to substantially exclude from use cans and lids showing open seams, cracks, rust condition, milkstone or an unsanitary condition.
(2) Washers shall be maintained in a clean and satisfactory operating condition and kept free from accumulation of scale or debris which will adversely affect the efficiency of the washer.
(c) Transport tanks. An enclosed wash dock and cleaning and sanitizing facilities shall be available to all plants that receive or ship milk in tanks. Milk transport tanks, sanitary piping, fittings and pumps shall be cleaned and sanitized at least once each day, after use. If milk transport tanks, sanitary piping, fittings or pumps are not to be used immediately after emptying a load of milk, they shall be washed promptly after use and given bactericidal treatment immediately before use. The following provisions also apply:
(1) A milk transport tank shall be cleaned and sanitized at least once each day after use.
(2) If a milk transport tank has been cleaned and sanitized in accordance with paragraph (1) and 96 hours or more have elapsed from that cleaning and sanitizing without the tank being used, the tank shall be cleaned and sanitized again before use.
(3) When a milk transport tank has been cleaned and sanitized, it must bear a tag or be accompanied by a written document showing the date, time and place of cleaning and sanitizing and bear the signature or initials of the person who performed the cleaning and sanitizing. This tagging or written document requirement is not applicable if the milk transport tank delivers to only one receiving facility and that receiving facility is solely responsible for cleaning and sanitizing and retains records at that receiving facility to confirm date, time and place of cleaning.
(4) A tag or written document as described in paragraph (3) shall be removed at the location where the milk tank truck is next cleaned and sanitized and retained on file at that location for 15 days.
(d) Buildings. Windows, glass, partitions and skylights shall be washed as often as necessary to keep them clean. Cracked or broken glass shall be replaced promptly. The walls, ceilings and doors shall be washed periodically and kept free from soil and unsightly conditions. The shelves and ledges shall be wiped or vacuumed as often as necessary to keep them free from dust and debris. The material picked up by the vacuum cleaners shall be disposed of by burning or other proper methods to destroy any insects that might be present.
§ 59a.312. Insect and rodent control program.
In addition to any commercial pest control service, if one is utilized, a specifically designated employee shall be made responsible for the performance of a regularly scheduled insect and rodent control program. Poisonous substances, insecticides and rodenticides must be properly labeled, and shall be handled, stored and used so that they do not create a public health hazard.
§ 59a.313. Plant records.
A milk plant shall retain adequate records of required tests on raw milk receipts. Records shall be available for examination at reasonable times by the Department. The following records shall be maintained for examination at the plant or receiving station where performed:
(1) Sediment, drug residue and bacterial test results on raw milk from each producer: retain for 12 months.
(i) Routine tests and monthly summary of all producers showing number and percent of total in each class.
(ii) Retests, if initial test places milk in probationary status.
(iii) Rejection of raw milk over No. 3 in quality.
(2) Positive drug residue tests: retain for 12 months.
(3) Pasteurization recorder charts: retain for 6 months.
(4) Water test reports: retain copies for 6 months.
(5) Employee health certificate: retain most recent copy until employee is no longer employed by plant.
(6) Drug residue test results for milk samples that do not test positive: retain for 6 months.
§ 59a.314. Packaging and general identification.
(a) Containers. Containers must meet the following standards:
(1) The size, style and type of packaging used for manufactured dairy products shall be commercially acceptable containers and packaging materials which satisfactorily cover and protect the quality of the contents during storage and regular channels of trade and under normal conditions of handling. The weights and shape within each size and style shall be as nearly uniform as is practical.
(2) Packaging materials for dairy products shall be selected which provide sufficiently low permeability to air and vapor to prevent the formation of mold growth and surface oxidation. The wrapper must 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.
(b) Packaging and repackaging. Packaging dairy products or cutting and repackaging dairy products require a high level of sanitation to prevent the contamination of exposed product. The atmosphere of the packaging rooms, the equipment and packaging material must be practically free from mold and bacterial contamination. The method for checking the level of contamination shall be as prescribed by the Standard Methods for the Examination of Dairy Products.
(c) General identification. Commercial bulk packages containing dairy products manufactured under this subchapter must be adequately and legibly marked with the name of the product, net weight, name and address of processor or manufacturer or other assigned plant identification, lot number and other identification that may be required. Consumer packaged products must be legibly marked with the name of the product, net weight, name and address of packer, manufacturer or distributor and other identification required by the Department.
§ 59a.315. Storage of finished product.
(a) Dry storage. The finished product must be stored at least 18 inches from the wall in aisles, rows or sections and lots, so it is orderly and easily accessible for inspection. Rooms shall be cleaned regularly. Care shall be taken in the storage of products foreign to dairy products in the same room, to prevent impairment or damage to the dairy product from mold, absorbed odors, vermin or insect infestation. Control of humidity and temperature shall be maintained at all times, consistent with good commercial practices, to prevent conditions detrimental to the product and container.
(b) Refrigerated storage. The finished product must be placed on shelves, dunnage or pallets and properly identified. It must be stored under temperatures that will best maintain the initial quality. The product may not be exposed to anything from which it might absorb foreign odors or be contaminated by drippage or condensation.
§ 59a.316. Permits.
Plant permitting requires compliance with the applicable requirements in this subchapter.
SUPPLEMENTAL REQUIREMENTS FOR PLANTS MANUFACTURING, PROCESSING AND PACKAGING INSTANT NONFAT DRY MILK, NONFAT DRY MILK, DRY WHOLE MILK, DRY BUTTERMILK, DRY WHEY AND OTHER
DRY MILK PRODUCTS§ 59a.321. Requirements for rooms and compartments.
Rooms and compartments must conform to § 59a.302(f) (relating to buildings).
§ 59a.322. Dry storage.
(a) General requirement. Dry storage of instant nonfat dry milk, nonfat dry milk, dry whole milk, dry buttermilk, dry whey and other dry milk products must conform with § 59a.315 (relating to storage of finished product).
(b) Storage rooms. Storage rooms for the dry storage of product must be adequate in size, kept clean, orderly, free from rodents, insects and mold, and maintained in good repair. The rooms must be adequately lighted and ventilated. The ceilings, walls, beams and floors shall be free from structural defects and inaccessible false areas which may harbor insects.
§ 59a.323. Packaging room for bulk products.
A separate room or area shall be provided for filling bulk bins, drums, bags or other bulk containers and be constructed to conform to § 59a.302 (relating to buildings). The number of control panels and switchboxes in this area shall be kept to a minimum. Control panels must be mounted a sufficient distance from the walls to facilitate cleaning or be mounted in the wall and provided with tight-fitting removable doors to facilitate cleaning. An adequate exhaust system shall be provided to minimize the accumulation of product dust within the packaging room and, where needed, a dust collector shall be provided and properly maintained to keep roofs and outside areas free of dry product. Only packaging materials that are used within a day's operation may be kept in the packaging area. These materials shall be kept on metal racks or tables at least 6 inches off the floor. Unnecessary fixtures, equipment or false areas which may collect dust and harbor insects, may not be allowed in the packaging room.
§ 59a.324. Hopper or dump room.
A separate room shall be provided for the transfer of bulk dry dairy products from bags or drums to the hoppers and conveyors which lead to the fillers. The room must meet the same requirements for construction and facilities as the bulk packaging operation. Areas and facilities providing for the transfer of dry dairy products from portable bulk bins will be acceptable if gasketed surfaces or direct connections are used that essentially eliminate the escape of product into the area.
§ 59a.325. Repackaging room.
A separate room shall be provided for the filling of small packages and must meet the same requirements for construction and facilities as the bulk packaging operation.
§ 59a.326. Equipment and utensils.
Equipment and utensils must conform with § 59a.304 (relating to equipment and utensils). Additional, more specific requirements are applicable to the items of equipment listed in §§ 59a.327—59a.341.
§ 59a.327. Preheaters.
Preheaters must be of stainless steel or other equally corrosion-resistant material, cleanable, accessible for inspection and equipped with suitable automatic temperature controls.
§ 59a.328. Hotwells.
Hotwells must be enclosed or covered and equipped with indicating thermometers either in the hotwell or in the hot milk inlet line to the hotwell and if used for holding high heat products must also have recorders.
§ 59a.329. Evaporators or vacuum pans, or both.
Open-type evaporators or vacuum pans, or both, must be equipped with an automatic condenser water level control, barometric leg, or constructed to prevent water from entering the product, and meet the applicable 3-A Sanitary Standards. When enclosed-type condensers are used, special controls are not needed to prevent water from entering the product.
§ 59a.330. Surge tanks.
If surge tanks are used for hot milk and temperatures of products including foam being held in the surge tank during processing is not maintained at a minimum of 150° F, two or more surge tanks shall be installed with cross connections to permit flushing and cleaning during operation. Covers easily removable for cleaning shall be provided and used at all times.
§ 59a.331. High pressure pumps and lines.
High pressure lines may be cleaned in place and must be constructed so that deadends, valves and the high pressure pumps can be disassembled for hand cleaning. New high pressure pumps must meet the current 3-A Sanitary Standard Covering Homogenizers and High Pressure Pumps of the Plunger Type.
§ 59a.332. Dryers.
(a) Spray dryers. Spray dryers must conform to the current 3-A Accepted Practices for Spray Drying Systems. The filtering system shall be cleaned or component parts replaced as often as necessary to maintain a clean and adequate air supply. In gas-fired dryers, precautions shall be taken to assure complete combustion. Air must be drawn into the dryer from sources free from objectionable odors and smoke, dust or dirt.
(b) Roller dryers. Roller dryers must comply with the following:
(1) The drums of a roller dryer must be smooth, readily cleanable and free of pits and rusts. The knives shall be maintained in a condition so they do not cause scoring of the drums.
(2) The end boards must have an impervious surface and be readily cleanable. The end boards shall be provided with a means of adjustment to prevent leakage and accumulation of milk solids. The stack, hood, drip pan inside of the hood and related shields must be constructed of stainless steel and be readily cleanable. The lower edge of the hood must be constructed to prevent condensate from entering the product zone. The hood must be properly located and the stack of adequate capacity to remove the vapors. The stack must be closed when the dryer is not in operation. The augers must be of stainless steel or properly plated and be readily cleanable. The auger troughs and related shields must be of stainless steel and be readily cleanable. Air entering the dryer room shall be filtered to eliminate dust and dirt. The filter system must consist of a filtering media or device that will effectively, and in accordance with good commercial practices, prevent the entrance of foreign substances into the drying room. The filtering system must be cleaned or component parts replaced as often as necessary to maintain a clean and adequate air supply. Dryer adjustments must be made and the dryer operating normally before food grade powder can be collected from the dryer.
§ 59a.333. Collectors and conveyors.
Collectors must be made of stainless steel or equally noncorrosive material and constructed to facilitate cleaning and inspection. Filter sack collectors, if used, must comply with the current 3-A Sanitary Standards for Bag Collectors. Conveyors must comply with the current 3-A Sanitary Standards for Pneumatic Conveyors for Dry Milk and Dry Milk Products or the current 3-A Sanitary Standards for Mechanical Conveyors for Dry Products.
§ 59a.334. Dry dairy product cooling equipment.
Cooling equipment shall be provided with sufficient capacity to cool the products to 110° F or lower immediately after removal from dryer and prior to packaging. If bulk bins are used, the product should be cooled to approximately 90° F, but may not be more than 110° F. A suitable dry air supply with effective filtering shall be provided where air cooling and conveying is used.
§ 59a.335. Special treatment equipment.
Special equipment, such as flakers, pulverizers or hammer mills, used to further process dry milk products must be of sanitary construction and parts must be accessible for cleaning and inspection. Instantizing systems must comply with the current 3-A Accepted Practices for Instantizing Systems.
§ 59a.336. Sifters.
Newly installed sifters used for dry milk and dry milk products must meet the current 3-A Sanitary Standards for Sifters for Dry Products. Other sifters must be constructed of stainless steel or other equally noncorrosive material and must be of sanitary construction and accessible for cleaning and inspection. The mesh size of sifter screen used for various dry dairy products must be those recommended in the appendix of the referenced 3-A Sanitary Standard.
§ 59a.337. Portable and stationary bulk bins.
Bulk bins must be constructed of stainless steel, aluminum or other equally corrosion-resistant materials, free from cracks and seams and have an interior surface that is relatively smooth and easily cleanable. Product contact surfaces must be easily accessible for cleaning. Portable bins must comply with the current 3-A Sanitary Standards for Portable Bins for Dry Milk and Dry Milk Products.
§ 59a.338. Automatic sampling device.
When automatic sampling devices are used, they must be constructed to prevent contamination of the product, and parts must be readily accessible for cleaning.
§ 59a.339. Dump hoppers, screens and mixers.
The product contact surfaces of dump hoppers, screens and mixers which are used in the process of transferring dry products from bulk containers to fillers for small packages or containers must be of stainless steel or equally corrosion resistant material and designed to prevent contamination. Parts must be accessible for cleaning. The dump hoppers must be of a height above floor level to prevent foreign material or spilled product from entering the hopper.
§ 59a.340. Filler and packaging equipment.
Filling and packaging equipment must comply with the current 3-A Sanitary Standards for Equipment for Packaging Dry Milk and Dry Milk Products.
§ 59a.341. Heavy duty vacuum cleaners.
Each plant handling dry milk products must be equipped with a heavy duty industrial vacuum cleaner. Regular scheduling shall be established for its use in vacuuming applicable areas.
§ 59a.342. Clothing and shoe covers.
Clean clothing and shoe covers must be provided exclusively for the purpose of cleaning the interior of the dryer when it is necessary to enter the dryer to perform the cleaning operation.
§ 59a.343. Operations and operating procedures: Pasteurization.
(a) Pasteurization. Milk, buttermilk and whey used in the manufacture of dry dairy products shall be pasteurized at the plant where dried, except that condensed whey and acidified buttermilk containing 40% or more solids may be transported to another plant for drying without repasteurization. Milk or skim milk to be used in the manufacture of nonfat dry milk shall be heated prior to condensing to at least the minimum pasteurization temperature of 161° F for at least 15 seconds or its equivalent in bacterial destruction. Condensed skim made from pasteurized skim milk may be transported to a drying plant. The skim shall be effectively repasteurized at the drying plant, prior to drying, at a minimum temperature of 166° F for at least 15 seconds or its equivalent.
(b) Buttermilk. Buttermilk shall be pasteurized prior to condensing at a temperature of 161° F for 15 seconds or its equivalent in bacterial destruction.
(c) Cheese whey. Cheese whey or milk from which it is derived shall be pasteurized prior to condensing at a temperature of 161° F for 15 seconds or its equivalent in bacterial destruction.
(d) Cream derived from buttermilk. Cream derived from buttermilk shall be pasteurized prior to condensing at a temperature of 166° F for 15 seconds or its equivalent in bacterial destruction.
§ 59a.344. Operations and operating procedures: Condensed surge supply.
Surge tanks or balance tanks if used between the evaporators and dryer shall be used to hold the minimum amount of condensed product necessary for a uniform flow to the dryers. The tanks holding products at temperatures below 150° F shall be completely emptied and washed after each 4 hours of operation or less. Alternate tanks shall be provided to permit continuous operation during washing of tanks.
§ 59a.345. Operations and operating procedures: Condensed storage tanks.
(a) Excess production. Excess production of condensed products over that which the dryer will take continuously from the evaporator or pans should be by-passed through a cooler into a storage tank at 50° F or lower and held at this temperature until used.
(b) Regular cleaning and sanitizing. Product cut-off points shall be made at least every 24 hours and the tank completely emptied, washed and sanitized before reuse.
§ 59a.346. Operations and operating procedures: Drying.
Each dryer shall be operated at not more than the manufacturer's rated capacity for the highest quality dry product consistent with the most efficient operation. This does not preclude the remodeling or redesigning of dryers after installation when properly engineered and designed. The dry products shall be removed from the drying chamber continuously during the drying process.
§ 59a.347. Operations and operating procedures: Cooling dry products.
Prior to packaging and immediately following removal from the drying chamber, the dry product shall be cooled to a temperature not exceeding 110° F.
§ 59a.348. Operations and operating procedures: Packaging, repackaging and storage.
(a) Containers. Packages or containers used for the packaging of nonfat dry milk or other dry milk products must be any clean, sound, commercially accepted container or packaging material which satisfactorily protects the contents through the regular channels of trade, without significant impairment of quality with respect to flavor, wholesomeness or moisture content under the normal conditions of handling. Packages or containers that comply with 21 CFR 177.1520 (relating to olefin polymers) are among the packages that meet the requirements of this subsection. Containers which have previously been used for nonfood items or food which would be deleterious to the dairy product may not be used for the bulk handling of dairy products.
(b) Filling. Empty containers shall be protected from possible contamination and containers which are to be lined may not be prepared more than 1 hour in advance of filling. Every precaution shall be taken during the filling operation to minimize product dust and spillage. When necessary, a mechanical shaker shall be provided. The tapping or pounding of containers shall be prohibited. The containers shall be closed immediately after filling and the exteriors shall be vacuumed or brushed when necessary to render them practically free of product remnants before being transferred from the filling room to the palleting or dry storage areas.
(c) Repackaging. The entire repackaging operation shall be conducted in a sanitary manner with all precautions taken to prevent contamination and to minimize dust. Exterior surfaces of individual containers must be practically free of product before overwrapping or packing in shipping containers. The flow shall be kept free of dust accumulation, waste, cartons, liners or other refuse. Conveyors, packaging and carton making equipment shall be vacuumed frequently during the operating day to prevent the accumulation of dust. Bottles or glass materials may not be permitted in the repackaging or hopper room. The inlet openings of hoppers and bins must be of minimum size, screened and placed well above the floor level. The room and all packaging equipment shall be cleaned as often as necessary to maintain a sanitary operation. Close attention shall be given to cleaning points of equipment where residues of the dry product may accumulate. A thorough clean-up, including windows, doors, walls, light fixtures and ledges, shall be performed as frequently as is necessary to maintain a high standard of cleanliness and sanitation. Waste dry dairy products including dribble product at the fillers shall be properly identified and disposed of as animal feed.
(d) Storage. Storage shall be as follows:
(1) Product. The packaged dry milk product must be stored or arranged in aisles, rows or sections and lots at least 18 inches from a wall and in an orderly, easily accessible manner for inspection or for cleaning of the room. Bags and small containers of products must be placed on pallets elevated approximately 6 inches from the floor. The storage room shall be kept clean and dry and all openings protected against entrance of insects and rodents.
(2) Supplies. Supplies must be placed on dunnage or pallets and arranged in an orderly manner for accessibility and cleaning of the room. Supplies must be kept enclosed in their original wrapping material until used. After removal of supplies from their original containers, they must be kept in an enclosed metal cabinet, bins or on shelving, and if not enclosed shall be protected from powder and dust or other contamination. The room shall be vacuumed as often as necessary and kept clean and orderly.
§ 59a.349. Operations and operating procedures: Product adulteration.
Necessary precautions shall be taken throughout the entire operation to prevent the adulteration of one product with another. The commingling of one type of liquid or dry product with another shall be considered as an adulteration of the product. This does not prohibit the normal standardization of like products in accordance with good commercial practices or the production of specific products for special uses, if applicable labeling requirements are met.
§ 59a.350. Operations and operating procedures: Checking quality.
Milk, manufactured dairy products and dry milk products shall be subject to inspection and analysis by the plant for quality and condition throughout each processing operation. Line samples shall be taken periodically as an aid to quality control in addition to the regular routine analysis made on the finished products.
§ 59a.351. Operations and operating procedures: Requirements for instant nonfat dry milk.
(a) Sampling and testing. Instant nonfat dry milk offered for sale shall be sampled and tested by an approved laboratory at least once each month for the purpose of assuring that the product meets the requirements of subsection (b). The dry milk plant shall have each sublot of approximately 4,000 pounds tested and analyzed prior to being packaged or offered for sale. Products which do not meet the requirements of subsection (b) may not be offered as Extra Grade.
(b) Requirements for Extra Grade instant nonfat dry milk. Requirements are as follows:
(1) Flavor and odor. The flavor and odor must be sweet, pleasing and desirable but may possess the following flavors to a slight degree: chalky, cooked, feed or flat.
(2) Physical appearance. The physical appearance must possess a uniform white to light cream natural color and be reasonably free-flowing and free from lumps except those that readily break up with very slight pressure.
(3) Bacterial estimate. The standard plate count may not be more than 10,000 per gram.
(4) Coliform count. The coliform count may not be more than 10 per gram.
(5) Milkfat content. The milkfat may not be more than 1.25%.
(6) Moisture count. The moisture may not be more than 4.5%.
(7) Scorched particle content. Scorched particles may not be more than 15 mg.
(8) Solubility index. The solubility index may not be more than 1 milliliter.
(9) Titratable acidity. The titratable acidity may not be more than 0.15%.
(10) Dispersibility. The dispersibility may not be less than 85% by the Modified Moats-Dabbah Method, as recommended by the United States Department of Agriculture.
(11) Direct microscopic clump count. The direct microscopic clump count may not be more than 40 million per gram.
(12) USDA grading. The product must be graded as Extra Grade instant nonfat dry milk by the Dairy Grading Branch, United States Department of Agriculture.
§ 59a.352. Operations and operating procedures: Cleaning of dryers, conveyors, sifters and storage bins.
Dryers, conveyors, sifters and storage bins shall be cleaned as often as necessary to maintain the equipment in a clean and sanitary condition. The kind of cleaning procedure—either wet or dry—and the frequency of cleaning, shall be based upon observation of actual operating results and conditions.
§ 59a.353. Operations and operating procedures: Insect and rodent control program.
In addition to any commercial pest control service, if one is utilized, a specifically designated employee shall be made responsible for the performance of a regularly scheduled insect and rodent control program.
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