Subchapter G. MANUFACTURING PLANTS

§ 59.701. Surroundings.

 Buildings shall 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.

   (1)  Outside doors, windows, openings, and the like, shall conform with §  59.203 (relating to doors and windows).

   (2)  Walls, ceilings, partitions, and posts shall conform with §  59.202 (relating to walls and ceilings—construction).

   (3)  Floors shall conform with §  59.201 (relating to floors—construction).

   (4)  Lighting and ventilation shall comply with the following:

     (i)   Light shall 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 shall have at least 20 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 shall 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 shall be protected against breakage.

     (ii)   There shall be adequate heating, ventilation or air conditioning for all rooms and compartments to permit maintenance of sanitary conditions. Exhaust or inlet fans, vents, hoods or temperature and humidity control 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. When not in use, exhaust outlets shall be screened or provided with self-closing louvers to prevent the entrance of insects.

   (5)  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 shall be separated from the processing rooms by a partition. Rooms for receiving can milk shall 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 shall comply with the following:

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

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

     (iii)   Boiler rooms, shop room, and service areas. The boiler rooms, shop room and service areas shall 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.

     (iv)   Toilet and dressing rooms. Adequate toilet and dressing rooms facilities shall be conveniently located.

       (A)   Toilet rooms may not open directly into a room where milk or dairy products are processed, manufactured, packaged, or stored. Doors shall be self-closing. Ventilation shall be provided by mechanical means or screened openings to the outer air. Fixtures shall be kept clean and in good repair.

       (B)   All employes 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 employes to wash their hands before returning to work.

     (v)   Laboratory. The permit holder 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, to meet requirements established by the Department. If the permit holder 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.

     (vi)   Starter facilities. Adequate sanitary facilities shall be provided for the handling of starter cultures.

     (vii)   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 employes to wash their hands before returning to work.

 (a)  Water supplies shall conform with §  59.207 (relating to water supply).

 (b)  Sanitary drinking water facilities shall be provided in the plant and shall be conveniently located.

 (c)  Handwashing facilities shall conform with §  59.208 (relating to handwashing facilities).

 (d)  Steam shall conform with §  59.215(e) (relating to protection from contamination).

 (e)  Air under pressure shall conform with §  59.215(e).

 (a)  General construction, repair, and installation shall conform with § §  59.210 and 59.211 (relating to sanitary piping; and construction and repair of containers and equipment).

 (b)  Weigh cans and receiving tanks shall conform with §   59.215(d)(3) (relating to protection from contamination).

 (c)  Can washers shall 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 shall maintain a reasonably uniform pressure and if necessary be equipped with pressure regulating valves.

 (d)  Product storage tanks or vats shall conform with §  59.211.

 (e)  Product contact surfaces of separators shall be free from rust and pits and insofar as practicable shall be of stainless steel or other equally noncorrosive metals.

 (f)  Batch pasteurizers shall conform with §  59.216a (relating to batch pasteurization requirements).

 (g)  High-temperature, short-time pasteurizers shall conform with §  59.216b (relating to high temperature short-time (HTST) continuous flow pasteurization requirements).

 (h)  Thermometers and recorders shall conform with §  59.216b(e).

 (i)  Surface coolers shall conform with §  59.217(d) (relating to cooling of milk).

 (j)  Plate-type heat exchangers shall meet the 3-A Sanitary Standards for Construction and Installation. Gaskets shall 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.

 (k)  Internal return tubular heat exchangers shall conform with §   59.211.

 (l)  Pumps shall conform with §  59.211.

 (m)  Homogenizers shall conform with §  59.211.

 (n)  New equipment and replacements shall conform with §  59.211.

 (o)  A vacuum chamber, as used for flavor control, shall be made of stainless steel or other equally noncorrosive metal. The unit shall be constructed to facilitate cleaning and product contact surfaces shall be accessible for inspection. It shall be equipped with a vacuum breaker and a check valve at the product discharge line. Only steam which meets the requirements for culinary steam shall 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 shall be equipped with a water level control and an automatic safety shutoff valve.

 (a)  Equipment and facilities.

   (1)  Milk cans shall conform with §  59.109 (relating to utensils and equipment—construction).

   (2)  Farm bulk tanks shall conform with §  59.109.

 (b)  Transporting milk or cream.

   (1)  Vehicles shall conform with §  59.120 (relating to vehicles).

   (2)  The exterior shell of transport tanks shall be clean and free from open seams or cracks which would permit liquid to enter the jacket. The interior shell shall be stainless steel and constructed so it will not buckle, sag, or prevent complete drainage. Product contact surfaces shall be smooth, easily cleaned, and maintained in good repair. The pump and hose cabinet shall be fully enclosed with tight fitting doors and the inlet and outlet shall be provided with dust covers to give adequate protection from road dust. New and replacement transport tanks shall meet 3-A Sanitary Standards for Milk Transport Tanks.

 (c)  Cleaning and sanitizing facilities. Facilities for cleaning and sanitizing shall be convenient and conform with §  59.253 (relating to tank truck cleaning and sanitation facilities requirements).

 (a)  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 shall not be used for the manufacture of dairy products. Bulk milk in storage tanks within the dairy 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, where applicable to particular manufacturing or processing practices.

 (b)  The bacteriological quality of commingled milk in storage tanks shall be 3 million/ml or lower.

 (a)  Equipment and utensils. Equipment and utensils shall conform with §  59.212 (relating to cleaning and sanitizing containers and equipment).

 (b)  Milk cans and can washers. Milk cans and can washers shall comply with the following:

   (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. Milk transport tanks shall conform with §  59.212(a) and (b) and §  59.253 (relating to tank truck cleaning and sanitation facilities requirements).

 Adequate plant records shall be maintained of required tests on raw milk receipts. Records shall be available for examination at reasonable times by the Secretary or his agent. The following are the records which shall be maintained for examination at the plant or receiving station where performed:

   (1)  Sediment 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)  Pasteurization recorder charts: retain for 12 months.

 (a)  Containers. Containers shall comply with the following:

   (1)  The size, style and type of packaging used for 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 will provide sufficiently low permeability to air and vapor to prevent the formation of mold growth and surface oxidation. The wrapper shall be resistant to puncturing, tearing, cracking, or breaking under normal conditions of handling, shipping and storage. When special type packaging is used, the instructions of the manufacturers shall be followed closely as to its application and methods of closure.

 (b)  Packaging and repackaging. Packaging dairy products or cutting and repackaging styles of dairy products shall be conducted under rigid sanitary conditions. The atmosphere of the packaging rooms, the equipment and packaging material shall be practically free from mold and bacterial contamination. Method for checking the level of contamination shall be as prescribed by the current edition of Standard Methods.

 (a)  Dry storage. The finished product shall 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, in order 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 shall be placed on shelves, dunnage or pallets and properly identified. It shall 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.

 Permits shall be required as specified in §  59.17 (relating to 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

§ 59.721. Requirements for rooms and compartments.

 (a)  Spray dryers. Spray dryers shall be of a continuous discharge type and all product contact surfaces shall be of stainless steel or other equally corrosion-resistant material. Joints and seams in the product contact surfaces shall be welded and ground smooth. Dryers shall be constructed so as to facilitate ease of cleaning and inspection. Sight glasses or ports of sufficient size shall be located at strategic positions. Dryers shall be equipped with suitable air intake filters and with air intake and exhaust recording thermometers. The filter system shall consist of filtering media or devices that shall effectively, and in accordance with good commercial practices, prevent the entrance of foreign substances into the drying chamber. 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 shall be drawn into the dryer from sources free from objectionable odors and smoke, dust, or dirt.

 (b)  Roller dryers. Roller dryers shall comply with the following:

   (1)  The drums of a roller dryer shall be smooth, readily cleanable and free of pits and rusts. The knives shall be maintained in a condition so they don’t cause scoring of the drums.

 (a)  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; however, it shall be effectively repasteurized at the drying plant, prior to drying, at not less than 175°F for 25 seconds or its equivalent in bacterial destruction.

 (b)  Buttermilk or cream from which it is derived shall be pasteurized prior to condensing at a temperature of 185°F for 15 seconds or its equivalent in bacterial destruction.

 (a)  Excess production of condensed products over that which the dryer will take continuously from the pans should be by-passed through a cooler into a storage tank at 50°F or lower and held at this temperature until used.

 (a)  Containers. Packages or containers used for the packaging of nonfat dry milk or other dry milk products shall be a clean, sound commercially accepted container or packaging material which shall satisfactorily protect 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. 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 shall 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 cartonmaking equipment shall be vacuumed frequently during the operating day to prevent the accumulation of dust. No bottles or glass materials shall be permitted in the repackaging or hopper room. The inlet openings of hoppers and bins shall 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. All 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 shall 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 shall 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.

 (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 5,000 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 shall be sweet, pleasing and desirable but may possess the following flavors to a slight degree: Chalky, cooked, feed, flat.

   (2)  Physical appearance. The physical appearance shall possess a uniform white to light cream natural color and shall 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 shall not be more than 30,000 per gram.

   (4)  Coliform count. The coliform count shall not be more than 10 per gram.

   (5)  Milkfat content. The milkfat shall not be more than 1.25%.

   (6)  Moisture count. The moisture shall not be more than 4.5%.

   (7)  Scorched particle content. Scorched particles shall not be more than 15 mg.

   (8)  Solubility index. The solubility index shall not be more than 1 ml.

   (9)  Titratable acidity. The titratable acidity shall 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.

 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.

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

§ 59.761. Rooms and compartments.

 (a)  Coolers and freezers. The coolers and freezers shall be equipped with facilities for maintaining proper temperature and humidity conditions, consistent with good commercial practices for the applicable product, 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 shall be adequately lighted and proper circulation of air shall be maintained at all times. The floors, walls and ceilings shall be of a construction that permits thorough cleaning.

 (b)  Churn rooms. Churn rooms, in addition to proper construction and sanitation, shall 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.

 (a)  General construction, repair and installation. Equipment and utensils necessary to the manufacture of butter and related products shall meet requirements of §  59.704 (relating to equipment and utensils). For certain other equipment, the requirements of this section shall be met.

 (b)  Continuous churn. Product contact surfaces shall be of noncorrosive material. Nonmetallic product contact surfaces shall comply with 3-A Standards for Plastic, Rubber, and Rubber-like Materials. Product contact surfaces shall be readily accessible for cleaning and inspection.

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

 (d)  Bulk butter trucks, boats and packers. Bulk butter trucks, boats and packers shall be constructed of aluminum, stainless steel or equally corrosion resistant metal free from cracks, seams and shall 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 shall be of stainless steel or equally corrosion resistant metal, sanitary construction and readily cleanable.

 (f)  Printing equipment. Printing equipment shall be designed to be readily demountable for cleaning of product contact surfaces. Product contact surfaces shall be aluminum, stainless steel or equally corrosion resistant metal, or plastic, rubber and rubber-like material which meet 3-A Standards, except that conveyors may be constructed of material which can be properly cleaned and maintained in a satisfactory manner.

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

 (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 not less than 165°F and held continuously in a vat at that temperature for not less than 30 minutes; or pasteurized by HTST method at a minimum temperature of not less than 185°F for not less than 15 seconds; or by another equivalent time and temperature combination. 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 no 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 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 subparagraph (i) except that the temperature for the vat method shall be not less than 170°F for not less than 30 minutes, or not less than 190°F for not less than 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 shall 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 shall comply with the requirements of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.A. § §  301—392), as to composition and wholesomeness.

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

   (1)  Containers used for the packaging of butter and related products shall 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 shall comply with the following:

     (i)   Supplies of parchment liners, wrappers, and other packaging material shall 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 not less than 30 minutes. The solution shall 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 shall 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 shall be marked with the percent of milkfat.

 (f)  Storage of finished product in coolers. Products shall 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 shall 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 shall comply with the following:

     (i)   The room shall be maintained at a temperature of 0°F or lower. Adequate air circulation is desirable.

     (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

§ 59.771. 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, of the room, equipment and of the air therein.

 (b)  Make room. The room in which the cheese is manufactured shall 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.

 (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 shall 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 shall 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 shall 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 shall be free from rodents, insects, and pests. The shelves shall be kept clean and dry.

 (a)  General construction, repair, and installation. Equipment and utensils necessary to the manufacture of cheese and related products shall meet the requirements of §  59.704 (relating to equipment and utensils). For other equipment the requirements in this section shall be met.

 (b)  Starter vats. Bulk starter vats shall be of stainless steel or equally corrosion resistant metal and shall 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 shall be as follows:

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

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

   (3)  Copper Swiss kettles will be acceptable and need not be equipped with outlet valves.

 (d)  Mechanical agitators. The mechanical agitators shall be of sanitary construction. The carriage and track shall be constructed to prevent the dropping of dirt or grease into the vat. Metal blades, forks or stirrers shall be constructed of stainless steel and of material approved in the 3-A Sanitary Standards for Plastic and Rubber or Rubber-like Materials and shall 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 shall be stainless steel or of material approved in the 3-A Sanitary Standards for Plastic and Rubber-Like Material. The product contact surfaces of the curd mill shall be of stainless steel. Pieces of equipment shall be constructed so they can be kept clean. The wires in the curd knives shall be stainless steel, kept tight and replaced when necessary.

 (f)  Hoops and followers. The hoops, forms, and followers shall 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 shall be clean and sanitary.

 (g)  Press. The cheese press shall be constructed of stainless steel and all joints welded and all surfaces, seams and openings readily cleanable. The pressure device shall 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 shall have square interior corners, reasonably smooth interior surface and have controls that shall provide uniform pressure and heat equally to all surfaces.

 (a)  Cheese from pasteurized milk.

   (1)  If 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 not less than 15 seconds, or equivalent pasteurization process approved by the Secretary.

   (2)  HTST pasteurization units shall 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. If 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 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.

 (d)  Packaging and repackaging. Packaging rindless cheese or cutting and repackaging all styles of bulk cheese shall be conducted under rigid sanitary conditions. The atmosphere of the packaging rooms, the equipment and the packaging material shall be practically free from mold and bacterial contamination.

 (e)  General identification. Each bulk cheese shall 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 shall 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.

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

§ 59.781. Equipment and utensils.

 (a)  General construction, repair, and installation. The equipment and utensils used for the handling and processing of cheese products shall be as specified in §  59.704 (relating to equipment and utensils). For other equipment, the requirements in this section shall be met.

 (b)  Conveyors. Conveyors shall 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 shall be adequate in size. Product contact surfaces shall 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 shall be the steam jacketed or direct steam type. They shall be constructed of stainless steel or other equally corrosion resistant material. Product contact surfaces shall be readily accessible for cleaning. Each cooker shall be equipped with an indicating thermometer, and should be equipped with a temperature recording device. The recording thermometer stem may be placed in the cooker if satisfactory time charts are used; if not, the stem shall be placed in the hot-well of filler hopper. Steam check valves on direct steam type cookers shall be mounted flush with cooker wall, be constructed of stainless steel and designed to prevent the backup of product into the steam line, or the steam line shall 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.

 (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 and the contents pasteurized at a temperature of at least 158°F and held at that temperature for not less than 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. The handling of containers by filler crews shall be done with extreme care and observance of personal cleanliness. 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 shall effectively measure the desired amount of product into the pouch or container in a sanitary manner and shall 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, so as to assure against contamination. Each container in addition to other required labeling shall be coded in a manner that is easily identifiable as to date of manufacture by lot or sublot number.

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

§ 59.791. 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 §  59.704 (relating to equipment and utensils). All requirements for low acid can food products shall be met. For other equipment, the requirements of this section shall be met.

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

 (c)  Fillers. Both gravity and vacuum type fillers shall be of sanitary design and all product contact surfaces, if metal, shall 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. Nonmetallic product contact surfaces shall meet the requirements for 3-A Sanitary Standards for Rubber and Rubber-Like Materials or for Multiple-Use Plastic Materials. Fillers shall be designed so that they in no way will contaminate or detract from the quality of the product being packaged.

 (d)  Batch or continuous incontainer sterilizers. Batch or continuous incontainer sterilizers shall 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.

 (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 §  59.704 (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 shall 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 shall 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.