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.

Cross References

   This subchapter E cited in 7 Pa. Code §  59a.2 (relating to definitions).

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.

Cross References

   This section cited in 7 Pa. Code §  59a.321 (relating to requirements for rooms and compartments); and 7 Pa. Code §  59a.323 (relating to packaging room for bulk products).

§ 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.

Cross References

   This section cited in 7 Pa. Code §  59a.326 (relating to equipment and utensils); 7 Pa. Code §  59a.362 (relating to equipment and utensils); 7 Pa. Code §  59a.372 (relating to equipment and utensils); 7 Pa. Code §  59a.382 (relating ti equipment and utensils); 7 Pa. Code §  59a.391 (relating to equipment and utensils); and 7 Pa. Code §  59a.392 (relating to operations and operating procedures).

§ 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.

Cross References

   This section cited in 7 Pa. Code §  59a.322 (relating to dry storage).

§ 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.

Cross References

   This section cited in 7 Pa. Code §  59a.326 (relating to equipment and utensils).

§ 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.

Cross References

   This section cited in 7 Pa. Code §  59a.304 (relating to equipment and utensils); and 7 Pa. Code §  59a.326 (relating to equipment and utensils).

§ 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.

Cross References

   This section cited in 7 Pa. Code §  59a.326 (relating to equipment and utensils).

§ 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.

Cross References

   This section cited in 7 Pa. Code §  59a.326 (relating to equipment and utensils).

§ 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.

Cross References

   This section cited in 7 Pa. Code §  59a.326 (relating to equipment and utensils).

§ 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.

Cross References

   This section cited in 7 Pa. Code §  59a.326 (relating to equipment and utensils).

§ 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.

Cross References

   This section cited in 7 Pa. Code §  59a.326 (relating to equipment and utensils).

§ 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.

Cross References

   This section cited in 7 Pa. Code §  59a.326 (relating to equipment and utensils).

§ 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.

Cross References

   This section cited in 7 Pa. Code §  59a.326 (relating to equipment and utensils).

§ 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.

Cross References

   This section cited in 7 Pa. Code §  59a.326 (relating to equipment and utensils).

§ 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.

Cross References

   This section cited in 7 Pa. Code §  59a.326 (relating to equipment and utensils).

§ 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.

Cross References

   This section cited in 7 Pa. Code §  59a.326 (relating to equipment and utensils).

§ 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.

Cross References

   This section cited in 7 Pa. Code §  59a.326 (relating to equipment and utensils).

§ 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.

Cross References

   This section cited in 7 Pa. Code §  59a.326 (relating to equipment and utensils).

§ 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.

Cross References

   This section cited in 7 Pa. Code §  59a.326 (relating to equipment and utensils).

§ 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.

Cross References

   This section cited in 7 Pa. Code §  59a.304 (relating to equipment and utensils).

§ 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.

SUPPLEMENTAL REQUIREMENTS FOR
PLANTS MANUFACTURING, PROCESSING
AND PACKAGING BUTTER AND
RELATED PRODUCTS

§ 59a.361. Rooms and compartments.

 (a)  Coolers and freezers. The coolers and freezers must be equipped with facilities for maintaining proper temperature and humidity conditions, to protect the quality and condition of the products during storage or during tempering prior to further processing. Coolers and freezers shall be kept clean, orderly, free from insects, rodents and mold, and maintained in good repair. They must be adequately lighted and proper circulation of air shall be maintained at all times. The floors, walls and ceilings must be of a construction that permits thorough cleaning.

 (b)  Churn rooms. Churn rooms, in addition to proper construction and sanitation, must be equipped so the air is kept free from objectionable odors and vapors and extreme temperatures by means of adequate ventilation and exhaust systems or air conditioning and heating facilities.

 (c)  Print and bulk packaging rooms. Rooms used for packaging print or bulk butter and related products must, in addition to proper construction and sanitation, provide an atmosphere relatively free from mold (no more than 10 mold colonies per cubic foot of air), dust or other airborne contamination and be maintained at a reasonable room temperature.

§ 59a.362. Equipment and utensils.

 (a)  General construction, repair and installation. Equipment and utensils necessary to the manufacture of butter and related products must meet requirements in §  59a.304 (relating to equipment and utensils).

 (b)  Continuous churn. Product contact surfaces must be of noncorrosive material. Nonmetallic product contact surfaces must comply with 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. Product contact surfaces must be readily accessible for cleaning and inspection.

 (c)  Conventional churn. Churns must be constructed of aluminum, stainless steel or equally corrosion resistant metal, free from cracks and in good repair. Gasket material must be fat resistant, nontoxic and reasonably durable. Seals around the doors must be tight.

 (d)  Bulk butter trucks, boats and packers. Bulk butter trucks, boats and packers must be constructed of aluminum, stainless steel or equally corrosion resistant metal free from cracks, seams and have a surface that is relatively smooth and easily cleanable.

 (e)  Butter, frozen or plastic cream melting machines. Shavers, shredders or melting machines used for rapid melting of butter, frozen or plastic cream must be of stainless steel or equally corrosion resistant metal, sanitary construction and easily cleanable.

 (f)  Printing equipment. Printing equipment must comply with the current 3-A Sanitary Standards for Equipment for Packaging Viscous Products.

 (g)  Brine tanks. Brine tanks used for the treating of parchment liners must be constructed of noncorrosive material and have an adequate and safe means of heating the salt solution for the treatment of the liners. The tank must also be provided with a satisfactory drainage outlet.

 (h)  Starter vats. Bulk starter vats must be of stainless steel or equally corrosion resistant metal and constructed according to applicable 3-A Sanitary Standards. The vats must be in good repair, equipped with tight-fitting lids and have effective temperature controls.

§ 59a.363. Operations and operating procedures.

 (a)  Pasteurization. The milk or cream shall be pasteurized at the plant where the milk or cream is processed into the finished product.

   (1)  Cream for buttermaking. Requirements are as follows:

     (i)   The cream for buttermaking shall be pasteurized at a temperature of at least 165° F and held continuously in a vat at that temperature at least than 30 minutes, pasteurized by the HTST method at a minimum time and temperature of at least 185° F for at least 15 seconds or by another equivalent time and temperature combination that is approved by the Department. Additional heat treatment above the minimum pasteurization requirement is advisable to insure improved keeping quality characteristics.

     (ii)   Adequate pasteurization control shall be used and the diversion valve shall be set to divert at less than 185° F with a 15 second holding time or its equivalent in time and temperature to assure pasteurization. If the vat or holding method of pasteurization is used, vat covers shall be closed prior to the holding period to assure temperature of air space reaching the minimum temperature before holding time starts. Covers shall also be kept closed during the holding and cooling period.

   (2)  Cream for plastic or frozen cream. The pasteurization of cream for plastic or frozen cream shall be accomplished in the same manner as in paragraph (1)(i) except that the temperature for the vat method shall be at least 170° F for at least 30 minutes, at least 190° F for at least 15 seconds or by another temperature and holding time which will assure adequate pasteurization and comparable keeping quality characteristics.

 (b)  Composition and wholesomeness. Ingredients used in the manufacture of butter and related products shall be subject to inspection and must be wholesome and practically free from impurities. Chlorinating facilities shall be provided for butter wash water if needed and other necessary precautions shall be taken to prevent contamination of products. Finished products must comply with the Food, Drug, and Cosmetic Act (21 U.S.C.A. § §  301—399a), as to composition and wholesomeness.

 (c)  Containers. Containers must comply with the following:

   (1)  Containers used for the packaging of butter and related products must satisfactorily protect the quality of the contents in regular channels of trade. Caps or covers which extend over the lip of the container shall be used on all cups or tubs containing 2 pounds or less to protect the product from contamination during subsequent handling.

   (2)  Liners and wrappers must comply with the following:

     (i)   Supplies of parchment liners, wrappers and other packaging material must be protected against dust, mold and other possible contamination.

     (ii)   Prior to use, parchment liners for bulk butter packages shall be completely immersed in a boiling salt solution in a suitable container constructed of stainless steel or other equally noncorrosive material. The liners shall be maintained in the solution for at least 30 minutes. The solution must consist of at least 15 pounds of salt for every 85 pounds of water and shall be strengthened or changed as frequently as necessary to keep the solution full strength and in good condition.

     (iii)   Other liners, such as polyethylene, shall be treated or handled to prevent contamination of the liner prior to filling.

   (3)  The lined butter containers shall be protected from possible contamination prior to filling.

 (d)  Printing and packaging. Printing and packaging of consumer size containers of butter shall be conducted under sanitary conditions.

 (e)  General identification. Commercial bulk shipping containers must be legibly marked with the name of the product, net weight, name and address of manufacturer, processor or distributor or other assigned plant identification—manufacturer’s lot number, churn number, and the like—and other identification that may be required. Packages of plastic or frozen cream must be marked with the percent of milkfat.

 (f)  Storage of finished product in coolers. Products must be kept under refrigeration at temperatures of 40° F or lower after packaging and until ready for distribution or shipment. The products may not be placed directly on floors or exposed to foreign odors or conditions such as drippage due to condensation which might cause package or product damage.

 (g)  Storage of finished product in freezer.

   (1)  Sharp freezers. Plastic cream or frozen cream intended for storage shall be placed in quick freezer rooms immediately after packaging for rapid and complete freezing within 24 hours. The packages must be piled or spaced so that air can freely circulate between and around the packages. The rooms shall be maintained at -10° F or lower and shall be equipped to provide sufficient high-velocity air circulation for rapid freezing. After the products have been completely frozen, they may be transferred to a freezer storage room for continued storage.

   (2)  Freezer storage. Freezer storage must comply with the following:

     (i)   The room shall be maintained at a temperature of 0° F or lower. Air circulation must be sufficient to preclude odors and maintain uniform storage temperatures throughout the freezer.

     (ii)   Butter intended to be held more than 30 days shall be placed in a freezer room as soon as possible after packaging. If not frozen before being placed in the freezer, the packages shall be spaced to permit rapid freezing and repiled, if necessary, at a later time.

SUPPLEMENTAL REQUIREMENTS FOR
PLANTS MANUFACTURING AND
PACKAGING CHEESE

§ 59a.371. Rooms and compartments.

 (a)  Starter room. Starter rooms or areas shall be properly equipped and maintained for the propagation and handling of starter cultures. Necessary precautions shall be taken to prevent contamination of the starter, the room, equipment and the air therein.

 (b)  Make room. The room in which the cheese is manufactured must be of adequate size, and the vats adequately spaced to permit movement around the vats and presses for proper cleaning and satisfactory working conditions. Adequate ventilation shall be provided.

 (c)  Drying room. If cheese is to be paraffined, a drying room of adequate size shall be provided to accommodate the maximum production of cheese during the flush period. Adequate shelving and air circulation shall be provided for proper drying. Suitable temperature and humidity control facilities shall be provided. tion.

 (d)  Paraffining room or area. For rind cheese, a separate room or area shall be provided for paraffining and boxing the cheese. The room or area must be of adequate size and the temperature maintained near the temperature of the drying room to avoid sweating of the cheese prior to paraffining.

 (e)  Rindless block wrapping area. For rindless blocks, a suitable space shall be provided for proper wrapping and boxing of the cheese. The area must be free from dust, condensation, mold or other conditions which may contaminate the surface of the cheese or contribute to the unsatisfactory packaging of the cheese.

 (f)  Coolers or curing rooms. Coolers or curing rooms where cheese is held for curing or storage must be clean and maintained at the proper uniform temperature and humidity to adequately protect the cheese. Proper circulation of air shall be maintained at all times. The rooms must be free from rodents, insects and pests. The shelves shall be kept clean and dry.

 (g)  Cutting and packaging rooms. When small packages of cheese are cut and wrapped, separate rooms shall be provided for the cleaning and preparation of the bulk cheese and a separate room shall be provided for the cutting and wrapping operation. The rooms must be well lighted, ventilated and provided with filtered air. Air movement must be outward to minimize the entrance of unfiltered air into the cutting and packaging room.

§ 59a.372. Equipment and utensils.

 (a)  General construction, repair and installation. Equipment and utensils necessary to the manufacture of cheese and related products must meet the requirements of §  59a.304 (relating to equipment and utensils). In addition, for other equipment the following requirements in this section shall be met.

 (b)  Starter vats. Bulk starter vats must be of stainless steel or equally corrosion resistant metal and must be in good repair, equipped with tight-fitting lids and have adequate temperature controls, such as valves, indicating or recording thermometers. New vats shall be constructed according to the applicable 3-A Sanitary Standards.

 (c)  Cheese vats. Requirements are as follows:

   (1)  Open vats used for making cheese must be of metal construction with adequate jacket capacity for uniform heating. The inner liner must be minimum 16-gauge stainless steel, properly pitched from side to center and from rear to front for adequate drainage. The liner must be smooth, free from excessive dents or creases and extend over the edge of the outer jacket. The outer jacket must be constructed of stainless steel or other equally corrosion resistant metal which can be kept clean and sanitary. The junction of the liner and outer jackets must be constructed to prevent milk or cheese from entering the inner jacket.

   (2)  The vat must be equipped with a suitable sanitary outlet valve. Effective valves must be provided and properly maintained to control the application of heat to the vat.

   (3)  Enclosed cheese vats must meet the requirements of the current 3-A Sanitary Standards for Enclosed Cheese Vats and Tables.

 (d)  Mechanical agitators. The mechanical agitators must be of sanitary construction. The carriage and track must be constructed to prevent the dropping of dirt or grease into the vat. Metal blades, forks or stirrers must be constructed of stainless steel, and be free from rough or sharp edges which might scratch the equipment or remove metal particles.

 (e)  Curd mill and miscellaneous equipment. Knives, hand rakes, shovels, paddles, strainers and miscellaneous equipment must be stainless steel or of material approved in the 3-A Sanitary Standards. The product contact surfaces of the curd mill must be of stainless steel. Pieces of equipment must be constructed so they can be kept clean. The wires in the curd knives must be stainless steel or other suitable metal, kept tight and replaced when necessary.

 (f)  Hoops and followers. The hoops, forms and followers must be constructed of stainless steel or heavy tinned steel. If tinned, they shall be kept tinned and free from rust. Hoops, forms and followers shall be kept in good repair. Drums or other special forms used to press and store cheese must be clean and sanitary.

 (g)  Press. The cheese press must be constructed of stainless steel with all joints welded and all surfaces, seams and openings readily cleanable. The pressure device must be the continuous type. Press cloths shall be maintained in good repair and in a sanitary condition. Single-service press cloths shall be used only once.

 (h)  Rindless cheese press. The press used to heat seal the wrapper applied to rindless cheese must have square interior corners, reasonably smooth interior surface and have controls that provide uniform pressure and heat equally to all surfaces.

 (i)  Paraffin tanks. The metal tank must be adequate in size, have parafinned wood or metal racks to support the cheese, heat controls and an indicating thermometer. The cheese wax shall be kept clean.

 (j)  Automatic curd conveyors. When the salted curd is moved to a hooping station for blocks or barrels by means of an air conveying system, the nonproduct contact surfaces of the system must be constructed of suitable nontoxic material which is corrosion resistant. Product contact surfaces must be constructed of stainless steel with all joints welded or properly gasketed, and all surfaces readily accessible and cleanable. The air shall be filtered and of sufficient quality for the intended use. Air compressors or vacuum pumps may not be located in the processing or packaging areas.

 (k)  Whey probes. Vacuum equipment used to withdraw whey from cheese must be constructed of stainless steel tubes and be readily accessible and removable for cleaning and inspection.

 (l)  Cheese vacuumizer. Bulk cheese vacuum chambers, if used, must be installed so that floor surfaces underneath are effectively sealed or have enough clearance so they can be cleaned. Interior surfaces of the vacuum chamber must be constructed and maintained so that the product is not contaminated with rust or flaking paint. An inner liner of stainless steel or other corrosion resistant material shall be provided.

§ 59a.373. Operations and operating procedures.

 (a)  Cheese from pasteurized milk.

   (1)  When the cheese is labeled as pasteurized, the milk shall be pasteurized by subjecting every particle of milk to a minimum temperature of 161° F for at least 15 seconds.

   (2)  HTST pasteurization units must be equipped with the proper controls and equipment to assure pasteurization. If the milk is held more than 2 hours between time of receipt or heat treatment and setting, it shall be cooled to 45° F or lower until time of setting.

 (b)  Cheese from unpasteurized milk. When the cheese is labeled as ‘‘heat treated,’’ ‘‘unpasteurized,’’ ‘‘raw milk’’ or ‘‘for manufacturing,’’ the milk may be raw or heated at temperature below pasteurization. If the milk is held more than 2 hours between time of receipt or heat treatment and setting, it shall be cooled to 45° F or lower until time of setting.

 (c)  Whey disposal. Disposal of whey shall be as follows:

   (1)  Adequate sanitary facilities shall be provided for the disposal of whey. If outside, necessary precautions shall be taken to minimize flies, insects and development of objectionable odors.

   (2)  Whey or whey products intended for human food shall at all times be handled in a sanitary manner under this subpart as specified for handling milk and dairy products. Equipment operated on a batch or vat basis shall be cleaned or thoroughly rinsed between batches or vats. If equipment is operated on a continuous basis, the whey collection pans shall be rinsed at least once every 2 hours of operation with potable water.

 (d)  Packaging and repackaging. Packaging rindless cheese or cutting and repackaging all styles of bulk cheese requires a high level of sanitation to prevent the contamination of exposed product. The atmosphere of the packaging rooms, the equipment and the packaging material must be practically free from mold and bacterial contamination.

 (e)  General identification. Each bulk cheese must be legibly marked with the name of the product, code or date of manufacture, vat number, officially designated code number or name and address of manufacturer. Each consumer sized container must be plainly marked with the name and address of the manufacturer, packer, or distributor, net weight of the contents, name of the product and other information that may be required.

Cross References

   This ssection cited in 7 Pa. Code §  59a.304 (relating to equipment and utensils).

SUPPLEMENTAL REQUIREMENTS FOR
PLANTS MANUFACTURING, PROCESSING
AND PACKAGING PASTEURIZED PROCESS CHEESE AND RELATED PRODUCTS

§ 59a.381. Equipment and utensils.

 (a)  General construction, repair and installation. The equipment and utensils used for the handling and processing of cheese products must be as specified in §  59a.304 (relating to equipment and utensils). In addition, for certain other equipment the requirements in this section shall be met.

 (b)  Conveyors. Conveyors must be constructed of material which can be properly cleaned, will not rust, or otherwise contaminate the cheese, and shall be maintained in good repair.

 (c)  Grinders or shredders. The grinders or shredders used in the preparation of the trimmed and cleaned natural cheese for the cookers must be adequate in size. Product contact surfaces must be of corrosion resistant material, and of a construction to prevent contamination of the cheese and to allow thorough cleaning of all parts and product contact surfaces.

 (d)  Cookers. The cookers must be the steam jacketed or direct steam type. The cookers must be constructed of stainless steel or other equally corrosion resistant material. Product contact surfaces must be readily accessible for cleaning. Each cooker must be equipped with an indicating thermometer and a temperature recording device. Steam check valves on direct steam type cookers must be mounted flush with cooker wall, constructed of stainless steel and designed to prevent the backup of product into the steam line, or the steam line must be constructed of stainless steel pipes and fittings which can be readily cleaned. If direct steam is applied to the product, only culinary steam shall be used.

 (e)  Fillers. The hoppers of all fillers must be covered but the cover may have sight ports. If necessary, the hopper may have an agitator to prevent buildup on side wall. The filler valves and head shall be kept in good repair, capable of accurate measurements.

Cross References

   This section cited in 7 Pa. Code §  59a.304 (relating to equipment and utensils).

§ 59a.382. Operations and operating procedures.

 (a)  Trimming and cleaning. The natural cheese shall be cleaned free of all nonedible portions. Paraffin and bandages as well as rind surfaces, mold or unclean areas of another part which is unwholesome or unappetizing shall be removed.

 (b)  Cooking the batch. Each batch of cheese within the cooker, including the optional ingredients, shall be thoroughly commingled, the contents pasteurized at a temperature of at least 158° F and held at that temperature for at least 30 seconds. Care shall be taken to prevent the entrance of cheese particles or ingredients after the cooker batch of cheese has reached the final heating temperature. After holding for the required period of time, the hot cheese shall be emptied from the cooker as quickly as possible.

 (c)  Forming containers. Containers either lined or unlined shall be assembled and stored in a sanitary manner to prevent contamination. Procedures must be in place for the handling of containers between forming and filling that prevent contamination of the product contact surfaces. Preforming and assembling of pouch liners and containers shall be kept to a minimum and the supply rotated to limit the length of time exposed to possible contamination prior to filling.

 (d)  Filling containers. Hot fluid cheese from the cookers may be held in hotwells or hoppers to assure a constant and even supply of processed cheese to the filler or slice former. Filler valves must effectively measure the desired amount of product into the pouch or container in a sanitary manner and cut off sharply without drip or drag of cheese across the opening. An effective system shall be used to maintain accurate and precise weight control. Damaged or unsatisfactory packages shall be removed from production, and the cheese may be salvaged into sanitary containers and added back to cookers.

 (e)  Closing and sealing containers. Pouches, liners or containers having product contact surfaces after filling shall be folded or closed and sealed in a sanitary manner, preferably by mechanical means, to assure against contamination. Each container in addition to other required labeling must be coded in a manner that is easily identifiable as to date of manufacture by lot or sublot number.

Cross References

   This section cited in 7 Pa. Code §  59a.304 (relating to equipment and utensils).

SUPPLEMENTAL REQUIREMENTS FOR
PLANTS MANUFACTURING, PROCESSING AND PACKAGING EVAPORATED, CONDENSED OR STERILIZED MILK PRODUCTS

§ 59a.391. Equipment and utensils.

 (a)  General construction, repair and installation. The equipment and utensils used for processing and packaging evaporated and condensed milk shall be as specified in §  59a.304 (relating to equipment and utensils).

 (b)  Evaporators and vacuum pans. Equipment used in the removal of moisture from milk or milk products for the purpose of concentrating the solids must meet the requirements of the current 3-A Sanitary Standards for Milk and Milk Products Evaporators and Vacuum Pans. New or used replacements for this type of equipment must meet the appropriate 3-A Sanitary Standards.

 (c)  Fillers. Both gravity and vacuum type fillers must be of sanitary design and all product contact surfaces, if metal, must be made of stainless steel or equally corrosion resistant material. Certain evaporated milk fillers having brass parts may be approved if free from corroded surfaces and kept in good repair. Fillers must be designed so that they in no way will contaminate or detract from the quality of the product being packaged.

 (d)  Batch or continuous in-container sterilizers. Batch or continuous in-container sterilizers must be equipped with accurate temperature controls and effective valves for regulating the sterilization process. The equipment shall be maintained to assure control of the length of time of processing and to minimize the number of damaged containers.

 (e)  Homogenizers. Homogenizers, where applicable, shall be used to reduce the size of the fat particles and to evenly disperse them in the product. New homogenizers must meet the applicable 3-A Sanitary Standards.

§ 59a.392. Operations and operating procedures.

 (a)  Preheat, pasteurization. When pasteurization is intended or required by either the vat method, HTST method, or by the UHT method it shall be accomplished by systems and equipment meeting the requirements of §  59a.304 (relating to equipment and utensils).

 (b)  Sterilization. The complete destruction of all living organisms shall be performed in one of the following methods:

   (1)  The complete in-container method, by heating the container and contents to a range of 212° F to 280° F for a sufficient time.

   (2)  By a continuous flow UHTST process at high temperature of 280° F and above for a sufficient time, then packaged aseptically.

   (3)  The product is first sterilized according to UHTST methods as in paragraph (2), then packaged and given further heat treatment to complete the sterilization process.

 (c)  Filling containers.

   (1)  The filling of small containers with products shall be done in a sanitary manner. The containers may not contaminate or detract from the quality of the product in any way. After filling, the container shall be hermetically sealed.

   (2)  Bulk containers for unsterilized products must be suitable and adequate to protect the product in storage or transit. The bulk container, including bulk tankers, shall be cleaned and sanitized before filling, and filled and closed in a sanitary manner.

 (d)  Aseptic filling. A previously sterilized product shall be filled under conditions which prevent contamination of the product by living organisms or spores. The containers prior to being filled shall be sterilized and maintained in a sterile condition. The containers shall be sealed in a manner that prevents contamination of the product.

 (e)  Storage. Proper facilities shall be provided for the storage and handling of finished product.

Cross References

   This section cited in 7 Pa. Code §  59a.304 (relating to equipment and utensils).

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