[39 Pa.B. 4677]
[Saturday, August 1, 2009]

[Continued from previous Web Page]

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

59a.381.	Equipment and utensils.
59a.382.	Operations and operating procedures.

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

59a.391.	Equipment and utensils.
59a.392.	Operations and operating procedures.

GENERAL REQUIREMENTS

§ 59a.301. Premises.

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

   (b)  Surroundings. The adjacent surroundings of a manufacturing plant must be free from refuse, rubbish and waste materials to prevent harborage of rodents, insects and other vermin.

   (c)  Drainage. A suitable drainage system shall be provided which will allow rapid drainage of all water from manufacturing plant buildings and driveways, including surface water around the plant and on the premises. The water shall be disposed of in a manner that prevents a nuisance or health hazard.

§ 59a.302.  Buildings.

   (a)  General. Manufacturing plant buildings must be of sound construction and kept in good repair to prevent the entrance or harboring of rodents, birds, insects, vermin, dogs and cats. Service pipe openings through outside walls shall be effectively sealed around the opening or provided with tight metal collars.

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

   (c)  Walls, ceilings, partitions and posts. The walls, ceilings, partitions, posts of rooms in which milk or dairy products are processed, manufactured, handled, packaged or stored (except dry storage of packaged finished products and supplies) or in which utensils are washed and stored, must be smoothly finished with a suitable material of light color, which is substantially impervious to moisture and kept clean. They shall be refined as often as necessary to maintain a neat, clean surface.

   (d)  Floors.

   (1)  The floors of all rooms in which milk or dairy products are processed, manufactured, packaged or stored or in which utensils are washed must be constructed of tile properly laid with impervious joint material, concrete or other equally impervious material. The floors must be smooth, kept in good repair, graded so that there will be no pools of standing water or milk products after flushing, and the openings to the drains must be equipped with traps properly constructed and kept in good repair. On new construction, bell-type traps may not be used. The plumbing shall be installed to prevent the backup of sewage into the drain lines and to the floor of the plant.

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

   (e)  Lighting and ventilation. Lighting and ventilation must comply with the following:

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

   (2)  There must be adequate heating, ventilation or air conditioning for all rooms and compartments to permit maintenance of sanitary conditions. Exhaust or inlet fans, vents, hoods or temperature and humidity control facilities shall be provided where and when needed, to minimize or eliminate undesirable room temperatures, objectionable odors, moisture condensation or mold. Inlet fans shall be provided with an adequate air filtering device to eliminate dirt and dust from the incoming air. Ventilation systems shall be cleaned periodically as needed and maintained in good repair. Exhaust outlets must be screened or provided with self-closing louvers to prevent the entrance of insects when not in use.

   (f)  Certain rooms and compartments. Rooms and compartments in which raw material, packaging, ingredient supplies, or dairy products are handled, manufactured, packaged, or stored must 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. They 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 must 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.

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

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

§ 59a.303.  Facilities.

   (a)  Water supply. There shall be an ample supply of both hot and cold water of safe and sanitary quality, with adequate facilities for its proper distribution throughout the plant, and 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 be no 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 shall 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 where 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 shall be kept in good repair, free from cracks and corroded surfaces. New or rearranged equipment shall be set away from any wall or spaced a manner that facilitates proper cleaning and to maintain 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)  High-temperature, short-time 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, shall 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 accrate 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, where 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.

   (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 rubberlike materials for parts and gaskets having product contact surfaces, must meet the current 3-A Sanitary Standards or 3-A Accepted Practices. If 3-A Sanitary Standards or 3-A Accepted Practices are not available, the equipment and replacements must meet the general requirements of this section.

   (p)  Certain vacuum chambers. A vacuum chamber, as used for flavor control, must be made of stainless steel or other equally noncorrosive metal. The unit must be constructed to facilitate cleaning and product contact surfaces must be accessible for inspection. The chamber must be equipped with a vacuum breaker and a check valve at the product discharge line. Only steam which meets the requirements for culinary steam may be used. The incoming steam supply shall be regulated by an automatic solenoid valve which will cut off the steam supply in the event the flow diversion valve of the HTST pasteurizer is not in the forward flow position. Condensers when used must be equipped with a water level control and an automatic safety shutoff valve.

§ 59a.305.  Personnel cleanliness.

   Employees shall wash their hands before beginning work and upon returning to work after using toilet facilities, eating, smoking or otherwise soiling their hands. Employees shall keep their hands clean and follow good hygienic practices while on duty. Expectorating or use of tobacco in any form shall be prohibited in each room and compartment where any milk, dairy product or supplies are prepared, stored, or otherwise handled. Clean white or light-colored washable outer garments and caps (paper caps or hair nets acceptable) 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 where 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.

   (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 satisfactory. 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 will 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's use for thorough cleaning. Dairy cleaners, detergents, wetting agents, sanitizing agents or other similar materials which will not contaminate or adversely affect the products may be used. 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 where 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 must 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. After being washed and sanitized, each tank shall be identified by a tag attached to the outlet valve, bearing the information in the following paragraphs. The tag may not be removed until the tank is again washed and sanitized.

   (1)  The plant and specific location where cleaned.

   (2)  The date and time of day of washing and sanitizing.

   (3)  The name of person who washed and name of person who sanitized the tank.

   (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 specially 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 are the records which 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 will 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 styles of dairy products shall be conducted under rigid sanitary conditions. 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 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, 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.

§ 59a.316.  Permits.

   Plant permitting requires satisfactory compliance with the applicable requirements in Subchapter E (relating to manufarturing plants).

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 shall 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 shall be mounted a sufficient distance from the walls to facilitate cleaning or shall be mounted in the wall and provided with tight-fitting removable doors to facilitate cleaning. An adequate exhaust system shall be provided to minimize the accumulation of product dust within the packaging room and, where needed, a dust collector shall be provided and properly maintained to keep roofs and outside areas free of dry product. Only packaging materials that are used within a day's operation may be kept in the packaging area. These materials shall be kept on metal racks or tables at least 6 inches off the floor. Unnecessary fixtures, equipment, or false areas which may collect dust and harbor insects, may not be allowed in the packaging room.

§ 59a.324.  Hopper or dump room.

   A separate room shall be provided for the transfer of bulk dry dairy products from bags or drums to the hoppers and conveyors which lead to the fillers. The room must meet the same requirements for construction and facilities as the bulk packaging operation. Areas and facilities providing for the transfer of dry dairy products from portable bulk bins will be acceptable if gasketed surfaces or direct connections are used that essentially eliminate the escape of product into the area.

§ 59a.325.  Repackaging room.

   A separate room shall be provided for the filling of small packages and must meet the same requirements for construction and facilities as the bulk packaging operation.

§ 59a.326.  Equipment and utensils.

   Equipment and utensils must conform with § 59a.304 (relating to equipment and utensils). Additional, more specific requirements are applicable to the items of equipment listed in §§ 59a.327--59a.341.

§ 59a.327.  Preheaters.

   Preheaters must be of stainless steel or other equally corrosion-resistant material, cleanable, accessible for inspection and equipped with suitable automatic temperature controls.

§ 59a.328.  Hotwells.

   Hotwells must be enclosed or covered and equipped with indicating thermometers either in the hotwell or in the hot milk inlet line to the hotwell and if used for holding high heat products must also have recorders.

§ 59a.329.  Evaporators or vacuum pans, or both.

   Open-type evaporators or vacuum pans, or both, must be equipped with an automatic condenser water level control, barometric leg, or constructed to prevent water from entering the product, and meet the applicable 3-A Sanitary Standards. When enclosed-type condensers are used, no special controls are needed to prevent water from entering the product.

§ 59a.330.  Surge tanks.

   If surge tanks are used for hot milk and temperatures of products including foam being held in the surge tank during processing is not maintained at a minimum of 150° F, two or more surge tanks shall be installed with cross connections to permit flushing and cleaning during operation. Covers easily removable for cleaning shall be provided and used at all times.

§ 59a.331.  High pressure pumps and lines.

   High pressure lines may be cleaned in place and must be constructed so that deadends, valves and the high pressure pumps can be disassembled for hand cleaning. New high pressure pumps must meet the current 3-A Sanitary Standard Covering Homogenizers and High Pressure Pumps of the Plunger Type.

§ 59a.332.  Dryers.

   (a)  Spray dryers. Spray dryers must conform to the current 3-A Accepted Practices for Spray Drying Systems. The filtering system shall be cleaned or component parts replaced as often as necessary to maintain a clean and adequate air supply. In gas-fired dryers, precautions shall be taken to assure complete combustion. Air shall 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 don't 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 readily cleanable. The auger troughs and related shields must be of stainless steel and be readily cleanable. Air entering the dryer room shall be filtered to eliminate dust and dirt. The filter system must consist of a filtering media or device that will effectively, and in accordance with good commercial practices, prevent the entrance of foreign substances into the drying room. The filtering system must be cleaned or component parts replaced as often as necessary to maintain a clean and adequate air supply. Dryer adjustments must be made and the dryer operating normally before food grade powder can be collected from the dryer.

§ 59a.333.  Collectors and conveyors.

   Collectors must be made of stainless steel or equally noncorrosive material and constructed to facilitate cleaning and inspection. Filter sack collectors, if used, must comply with the current 3-A Sanitary Standards for Bag Collectors. Conveyors must comply with the current 3-A Sanitary Standards for Pneumatic Conveyors for Dry Milk and Dry Milk Products or the current 3-A Sanitary Standards for Mechanical Conveyors for Dry Products.

§ 59a.334.  Dry dairy product cooling equipment.

   Cooling equipment shall be provided with sufficient capacity to cool the products to 110° F or lower immediately after removal from dryer and prior to packaging. If bulk bins are used, the product should be cooled to approximately 90° F, but may not be more than 110° F. A suitable dry air supply with effective filtering shall be provided where air cooling and conveying is used.

§ 59a.335.  Special treatment equipment.

   Special equipment, such as flakers, pulverizers or hammer mills used to further process dry milk products must be of sanitary construction and parts must be accessible for cleaning and inspection. Instantizing systems must comply with the current 3-A Accepted Practices for Instantizing Systems.

§ 59a.336.  Sifters.

   Newly installed sifters used for dry milk and dry milk products must meet the current 3-A Sanitary Standards for Sifters for Dry Products. Other sifters must be constructed of stainless steel or other equally noncorrosive material and must be of sanitary construction and accessible for cleaning and inspection. The mesh size of sifter screen used for various dry dairy products must be those recommended in the appendix of the referenced 3-A Sanitary Standard.

§ 59a.337.  Portable and stationary bulk bins.

   Bulk bins must be constructed of stainless steel, aluminum or other equally corrosion-resistant materials, free from cracks and seams and have an interior surface that is relatively smooth and easily cleanable. Product contact surfaces must be easily accessible for cleaning. Portable bins must comply with the current 3-A Sanitary Standards for Portable Bins for Dry Milk and Dry Milk Products.

§ 59a.338.  Automatic sampling device.

   If automatic sampling devices are used, they must be constructed to prevent contamination of the product, and parts must be readily accessible for cleaning.

§ 59a.339.  Dump hoppers, screens and mixers.

   The product contact surfaces of dump hoppers, screens and mixers which are used in the process of transferring dry products from bulk containers to fillers for small packages or containers, must be of stainless steel or equally corrosion resistant material and designed to prevent contamination. Parts must be accessible for cleaning. The dump hoppers must be of a height above floor level to prevent foreign material or spilled product from entering the hopper.

§ 59a.340.  Filler and packaging equipment.

   Filling and packaging equipment must comply with the current 3-A Sanitary Standards for Equipment for Packaging Dry Milk and Dry Milk Products.

§ 59a.341.  Heavy duty vacuum cleaners.

   Each plant handling dry milk products must be equipped with a heavy duty industrial vacuum cleaner. Regular scheduling shall be established for its use in vacuuming applicable areas.

§ 59a.342.  Clothing and shoe covers.

   Clean clothing and shoe covers must be provided exclusively for the purpose of cleaning the interior of the dryer when it is necessary to enter the dryer to perform the cleaning operation.

§ 59a.343.  Operations and operating procedures: Pasteurization.

   (a)  Pasteurization. Milk, buttermilk and whey used in the manufacture of dry dairy products shall be pasteurized at the plant where dried, except that condensed whey and acidified buttermilk containing 40% or more solids may be transported to another plant for drying without repasteurization. Milk or skim milk to be used in the manufacture of nonfat dry milk shall be heated prior to condensing to at least the minimum pasteurization temperature of 161° F for at least 15 seconds or its equivalent in bacterial destruction. Condensed skim made from pasteurized skim milk may be transported to a drying plant. The skim shall be effectively repasteurized at the drying plant, prior to drying, at a minimum temperature of 166° F for at least 15 seconds or its equivalent.

   (b)  Buttermilk and cream derived from buttermilk. 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.

   (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.

§ 59a.344.  Operations and operating procedures: Condensed surge supply.

   Surge tanks or balance tanks if used between the evaporators and dryer shall be used to hold the minimum amount of condensed product necessary for a uniform flow to the dryers. The tanks holding products at temperatures below 150° F shall be completely emptied and washed after each 4 hours of operation or less. Alternate tanks shall be provided to permit continuous operation during washing of tanks.

§ 59a.345.  Operations and operating procedures: Condensed storage tanks.

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

   (b)  Regular cleaning and sanitizing. Product cut-off points shall be made at least every 24 hours and the tank completely emptied, washed and sanitized before reuse.

§ 59a.346.  Operations and operating procedures: Drying.

   Each dryer shall be operated at not more than the manufacturer's rated capacity for the highest quality dry product consistent with the most efficient operation. This does not preclude the remodeling or redesigning of dryers after installation when properly engineered and designed. The dry products shall be removed from the drying chamber continuously during the drying process.

§ 59a.347.  Operations and operating procedures: Cooling dry products.

   Prior to packaging and immediately following removal from the drying chamber, the dry product shall be cooled to a temperature not exceeding 110° F.

§ 59a.348.  Operations and operating procedures: Packaging, repackaging and storage.

   (a)  Containers. Packages or containers used for the packaging of nonfat dry milk or other dry milk products must be any clean, sound, commercially accepted container or packaging material which satisfactorily protects the contents through the regular channels of trade, without significant impairment of quality with respect to flavor, wholesomeness or moisture content under the normal conditions of handling. 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 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.

   (2)  Supplies. Supplies shall be placed on dunnage or pallets and arranged in an orderly manner for accessibility and cleaning of the room. Supplies shall be kept enclosed in their original wrapping material until used. After removal of supplies from their original containers, they shall 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, 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, 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 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 of § 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 readily 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; or pasteurized by 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, or 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 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 must 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

§ 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, of 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.

   (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 must 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, have 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)  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 at least 15 seconds.

   (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. 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 shall be conducted under rigid sanitary conditions. 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.

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 shall 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.

§ 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 and 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. 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 must effectively measure the desired amount of product into the pouch or container in a sanitary manner and must 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.

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). In addition, for certain 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 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.

Subchapter F.  RAW MILK FOR HUMAN CONSUMPTION

Sec.

59a.401.	Raw milk; General.
59a.402.	Raw milk; Prohibitions.
59a.403.	Raw milk permit.
59a.404.	Requirements for the issuance of a raw milk permit.
59a.405.	Sanitation.
59a.406.	Animal health.
59a.407.	Regular testing of water supply.
59a.408.	Regular testing of raw milk.
59a.409.	Violations of raw milk testing standards.
59a.410.	Location of raw milk packaging facilities on the dairy farm.
59a.411.	Label content review by the Department.
59a.412.	Inspection, sampling and testing by the Department.
59a.413.	Enforcement:  Suspension or revocation of a raw milk permit.
59a.414.	Enforcement:  Summary criminal prosecution.
59a.415.	Enforcement:  Injunctions.
59a.416.	Enforcement:  Seizure, condemnation, denaturing or destruction of raw milk; exclusion from sale.

§ 59a.401.  Raw milk; General.

   This subchapter prescribes the permitting, testing and inspection requirements that are applicable to persons seeking to sell raw milk for human consumption.

§ 59a.402.  Raw milk; Prohibitions.

   (a)  Sale of raw milk without permit. A person may not sell raw milk for human consumption without having a current raw milk permit issued by the Department. The term ''sell'' includes the selling, exchanging, delivering, or having in possession, care, control, or custody with intent to sell, exchange, or deliver, or to offer or to expose for sale.

   (b)  Actions authorized under a raw milk permit. A raw milk permit authorizes the permitholder to lawfully produce and sell (within this Commonwealth) raw whole milk for human consumption. It also authorizes the permitholder to obtain an additional permit, issued by the Department under authority of 21 CFR 133.150 (relating to hard cheeses), authorizing the sale of aged cheese manufactured from raw milk.

   (c)  Compliance with testing and documentation requirements. A person may not sell raw milk without being in compliance with the testing and documentation requirements of this section.

§ 59a.403.  Raw milk permit.

   (a)  Application. A raw milk permit application may be obtained by contacting the Department at the address set forth in § 59a.3 (relating to contacting the Department).

   (b)  Duration. A raw milk permit will be valid for no more than 1 year. Each raw milk permit will expire as of September 1 each year, unless revoked or suspended earlier by the Department.

   (c)  Timing of filing to ensure Department review of an application for a successor raw milk permit. If a raw milk permitholder wishes to obtain a raw milk permit to replace an expiring raw milk permit, the permitholder is encouraged, but is not required, to file an application for this successor raw milk permit with the Department by July 1 of the year in which the current raw milk permit is to expire. Compliance with this recommendation may help to prevent a lapse between the expiring raw milk permit and the effective date of the successor raw milk permit.

§ 59a.404.  Requirements for the issuance of a raw milk permit.

   (a)  Preissuance inspection.

   (1)  New raw milk permits. Prior to issuing a raw milk permit, the Department will inspect the dairy farm that is the subject of a new raw milk permit application, to determine whether the dairy farm is in compliance with the act and this chapter. The dairy farm must be in passing condition to be eligible for a raw milk permit.

   (2)  Successor raw milk permits. If a raw milk permit- holder applies to the Department for a successor raw milk permit, the Department may issue the raw milk permit without conducting the dairy farm inspection described in paragraph (1).

   (b)  Confirmation of Tuberculosis-free and Brucellosis-free status.

   (1)  New raw milk permits. An applicant for a new raw milk permit shall provide the Department confirmation that the animal or herd from which the raw milk is to be produced has been determined to be free from brucellosis and free from tuberculosis, in accordance with the process described in § 59a.406 (relating to animal health). This confirmation shall be provided for the subject dairy farm to be eligible for a raw milk permit.

   (2)  Successor raw milk permits. An applicant for a successor raw milk permit shall, at intervals of no greater than 13 months, provide the Department confirmation that the animal or herd from which the raw milk is to be produced has been determined to be free from brucellosis and tuberculosis by annual tests in accordance with the process described in § 59a.406.

   (c)  General herd health.

   (1)  New raw milk permits. An applicant for a new raw milk permit shall have a licensed veterinarian examine the herd and provide the Department a written report of this examination. The report must reflect that the herd is in good general health and free from communicable disease. This shall be done in accordance with § 59a.406.

   (2)  Successor raw milk permits. An applicant for a successor raw milk permit shall provide the Department a copy of a veterinary examination report as described in paragraph (1). The report must be dated within 1 year preceding the date of the application, and reflect that the herd is in general good health and free from communicable disease. The applicant shall continue to have this veterinary examination conducted on an annual basis, in accordance with § 59a.406.

   (d)  Confirmation of safe water supply.

   (1)  New raw milk permits. An applicant for a new raw milk permit shall have the dairy farm water supply tested, and provide the Department with confirmation that the water is bacteriologically safe, in accordance with § 59a.407 (relating to regular testing of water supply). Confirmation that the water supply is bacteriologically safe shall be provided for the subject dairy farm to be eligible for a raw milk permit. If the water supply is through a public or municipal water system, this testing requirement does not apply.

   (2)  Successor raw milk permits. An applicant for a successor raw milk permit shall provide the Department with a copy of a written laboratory report as described in paragraph (1). The report must be dated no earlier than 6 months preceding the date of the application, done in accordance with § 59a.407 and reflect that the dairy farm water supply is bacteriologically safe.

   (e)  Sampling and testing.

   (1)  New raw milk permits. An applicant for a new raw milk permit shall demonstrate its ability to produce raw milk for human consumption through the following process:

   (i)  The applicant shall have an approved sampler draw three separate samples of commingled milk. The samples shall be drawn at least 7 days apart, and be taken on an unannounced basis.

   (ii)  Each of these three samples described in subparagraph (i) shall be submitted to a Pennsylvania-approved dairy laboratory or the Department for analysis.

   (iii)  The analysis described in subparagraph (ii) will determine whether the sample meets the standards in § 59a.408 (relating to regular testing of raw milk).

   (iv)  If any of the three analyzed samples described in subparagraph (iii) violates or exceeds a standard in § 59.408, the three-sample process shall repeat itself until three successive samples are in compliance with the referenced standards.

   (v)  If the first of the three required samples is tested as described in subparagraph (iii), and concludes that no pathogenic bacteria are present, the second and third samples need not be tested for the presence of pathogenic bacteria. If a sample test concludes that pathogenic bacteria are present, a raw milk permit will not be issued until two separate consecutive tests, from samples drawn at least 7 days apart, conclude that no pathogenic bacteria are present.

   (2)  Successor raw milk permits. An applicant for a successor raw milk permit shall demonstrate its ability to produce raw milk for human consumption through the regular sampling and testing process described in § 59.408.

   (f)  Location of packaging-related facilities and equipment.

   (1)  Containers owned by the customer. If a dairy farm that is the subject of a raw milk permit or raw milk permit application packages raw milk for sale in containers that are owned by the customers, rather than by the permitholder, the Department will consider a milk room facility as being adequate for the packaging of this raw milk.

   (2)  Containers owned by the raw milk permitholder. If a dairy farm that is the subject of a raw milk permit or raw milk permit application packages raw milk for sale in containers that are owned by the permitholder, such as in prepackaged containers for consumer purchase, the dairy farm shall have separate rooms for bottling, single service container storage, and bottle washing. A mechanical means of filling and capping bottles shall be utilized for prepackaging, and the closure must protect the pouring lip to its largest diameter.

§ 59a.405.  Sanitation.

   A raw milk permitholder shall maintain and operate the subject dairy operation in compliance with the same sanitation and handling standards that are applicable to the production of milk for pasteurization, as set forth in § 59a.19 (relating to standards for grade ''A'' raw milk for pasteurization, ultra-pasteurization or aseptic processing) except to the extent any of those provisions are inconsistent with this subchapter. The provisions of the Grade ''A'' PMO and, in particular, the Standards for Grade ''A'' Raw Milk for Pasteurization, Ultrapasteurization or Aseptic Processing set forth in that document and section 7 of the Grade ''A'' PMO, regarding standards for Grade ''A'' milk and milk products, are incorporated by reference as regulations authorized under the act, to the extent they do not conflict with the act or this subchapter. This includes the items listed under the referenced Grade ''A'' PMO provisions, including the following:

   (1)  Item 1r. Abnormal milk.

   (2)  Item 2r. Milking Barn, Stable or Parlor--Construction.

   (3)  Item 3r. Milking Barn, Stable or Parlor--Cleanliness.

   (4)  Item 4r. Cowyard.

   (5)  Item 5r. Milkhouse--Construction and Facilities.

   (6)  Item 6r. Milkhouse--Cleanliness.

   (7)  Item 7r. Toilet.

   (8)  Item 8r. Water Supply, with the additional requirement that a plate heat exchanger or tubular cooler installed and in use on a dairy farm shall be equipped with a backflow prevention device.

   (9)  Item 9r. Utensils and Equipment--Construction.

   (10)  Item 10r. Utensils and Equipment--Cleaning.

   (11)  Item 11r. Utensils and Equipment--Sanitization.

   (12)  Item 12r. Utensils and Equipment--Storage.

   (13)  Item 13r. Milking--Flanks, Udders and Teats.

   (14)  Item 14r. Protection from Contamination.

   (15)  Item 15r. Drug and Chemical Control.

   (16)  Item 16r. Personnel--Handwashing Facilities.

   (17)  Item 17r. Personnel--Cleanliness.

   (18)  Item 18r. Raw Milk Cooling, with the exception that raw milk for pasteurization shall be cooled to 4° C (40° F) within 2 hours after the completion of milking.

   (19)  Item 19r. Insect and Rodent Control.

§ 59a.406.  Animal health.

   (a)  General. A raw milk permitholder shall monitor the health of the animals from which the raw milk is produced, to ensure that they are in general good health and free of tuberculosis and brucellosis.

   (b)  Confirmation of brucellosis-free status.

   (1)  Annual blood tests. A raw milk permitholder shall, at intervals of no greater than 13 months, provide the Department confirmation from a licensed veterinarian that the animal or herd from which the raw milk is produced has been determined to be free from brucellosis by annual blood tests conducted in accordance with Chapter 7 (relating to brucellosis regulations).

   (2)  Ring tests at intervals of 6 months or less. A raw milk permitholder shall, at intervals of no greater than 6 months, provide the Department confirmation of the results of a brucellosis ring test conducted with respect to the animal or herd from which the raw milk is produced.

   (c)  Annual confirmation of tuberculosis-free status. A raw milk permitholder shall, at intervals of no greater than 13 months, provide the Department confirmation from a licensed veterinarian that the animal or herd from which the raw milk is produced has been determined to be free from tuberculosis by annual tests conducted in accordance with Chapter 9 (relating to control and eradication of tuberculosis of livestock).

   (d)  Annual veterinary examination. A raw milk permit- holder shall, at intervals of no more than 1 year, have a licensed veterinarian examine the herd and issue a written report of this examination. The report must reflect that the herd is in good general health and free from communicable disease. The raw milk permitholder shall retain a copy of the written veterinarian's report for at least 3 years and shall, upon request of the Department, make the report available for inspection.

§ 59a.407.  Regular testing of water supply.

   (a)  General requirement of safe and sanitary water. The water supply for a dairy operation that produces raw milk under a raw milk permit must be safe and sanitary.

   (b)  Testing frequency. The water supply for a dairy operation that produces raw milk under a raw milk permit shall be tested at least once every 6 months, and whenever any repair or alteration is made to the water supply system. This testing shall be at the raw milk permitholder's expense. If the water supply is through a public or municipal water system, this testing requirement does not apply.

   (c)  Testing standards. The water tests described in this section shall be conducted at a qualified laboratory. The testing must include bacteriological examinations to determine whether the water is bacteriologically safe. The water supply must contain a Most Probable Number of Coliform Organisms (MPN) of less than 2.2-per-100-milliliters by the multiple tube fermentation method or less than 1-per-100-milliliters by the membrane filter technique or the chromogenic substrate technique. The water must otherwise be safe and sanitary.

   (d)  Water test records. The raw milk permitholder shall retain all records of required water tests, and make these available for inspection upon request of the Department.

§ 59a.408.  Regular testing of raw milk.

   (a)  Responsibility. A raw milk permitholder shall be responsible to arrange for the regular sampling and testing required with respect to the raw milk permit, and to pay for this testing.

   (b)  Testing laboratories. Raw milk samples submitted for testing shall be analyzed at an official laboratory or a Pennsylvania-approved dairy laboratory.

   (c)  Testing schedule and standards. A raw milk permit- holder shall coordinate raw milk testing on the following schedule, and the raw milk samples shall meet the following standards:

Raw Milk Testing Schedule and Standards

Required Action Interval	Type of Action or Test Required	Standard
At all times	Maintain raw milk temperature in accordance with raw milk temperature standards.	Raw milk shall be cooled to 40° F (4° C) or less within 2 hours after milking, provided that the blend temperature after the first and subsequent milking does not exceed 50° F (10° C).
At least twice each month, in conjunction with the tests for coliform count and for the presence of drugs (including growth inhibitors), described in this subsection	Bacterial count	Bacteria may not be present in excess of 20,000 per milliliter. NOTE:  Tested in conjunction with a drug residue/ inhibitory substance test.
At least twice each month, in conjunction with the tests for bacterial count and for the presence of drugs (including growth inhibitors), described in this subsection	Coliform count	Coliform may not exceed 10 per milliliter. NOTE:  Tested in conjunction with a drug residue/ inhibitory substance test.
At least twice each month	Somatic cell count	The somatic cell count may not exceed 750,000/milliliter.
At least twice each month, in conjunction with the tests for bacterial count and for coliform count, described in this subsection	Test for presence of drugs (including growth inhibitors)	There may be no positive results for drug residue, using drug residue detection laboratory techniques referenced in the current Grade ''A'' Pasteurized Milk Ordinance developed by the United States Department of Health and Human Services, Food and Drug Administration.
At least twice annually	Test for presence of pathogenic bacteria including Salmonellae, Listeria monocytogenes, Camphylobacter, and E. Coli 0157:H7	There may be no pathogenic bacteria present.

§ 59a.409.  Violations of raw milk testing standards.

   (a)  Bacterial count, somatic cell count, coliform count or cooling temperature tests.

   (1)  If two of the last four tested raw milk samples exceed the bacterial count, somatic cell count or coliform count standards or cooling temperature requirements described in § 59a.408 (relating to regular testing of raw milk), the Department will provide the raw milk permit- holder with written notice that it is in violation of the requirements of the act and this chapter.

   (2)  If three of the last five tested raw milk samples exceed the bacterial count, somatic cell count or coliform count standards or cooling temperature requirements described in § 59a.408, the Department will proceed to revoke or suspend the raw milk permit, and the raw milk permitholder shall be subject to summary criminal prosecution under the act.

   (b)  Pesticides. If a raw milk sample tests positive for the presence of a pesticide, the raw milk permitholder shall do all of the following:

   (1)  Immediately cease the sale of raw milk for human consumption.

   (2)  Take a second sample and submit it for testing for pesticide residue.

   (3)  Investigate and determine the cause of the contamination, report the result of that investigation to the Department, and correct that cause of contamination.

   (4)  Refrain from selling raw milk until and unless the second test shows the sample to be free of pesticide residue, or to be below the actionable levels established for the residue, and the Department reviews these test results and approves the resumption of raw milk sales.

   (c)  Growth inhibitor. If a raw milk sample tests positive for the presence of a growth inhibitor, the raw milk permitholder shall do the following:

   (1)  Immediately cease the sale of raw milk for human consumption.

   (2)  Investigate and determine the cause of the contamination, report the result of the investigation to the Department, and correct the cause of contamination.

   (3)  Have a second sample collected by an approved sampler and tested at a Pennsylvania-approved dairy laboratory.

   (4)  Refrain from selling raw milk until the second test shows the sample to be free of growth inhibitor residue, or to be below the actionable levels established for the residue, and the Department reviews these test results and approves the resumption of raw milk sales.

   (d)  Disease-producing organisms. If a raw milk sample tests positive for the presence of pathogenic bacteria or other disease-producing organisms such as Salmonellae, Listeria monocytogenes, Camphylobacter or E. Coli 0157:H7, the raw milk permitholder shall do the following:

   (1)  Immediately cease the sale of raw milk for human consumption.

   (2)  Investigate and determine the cause of the contamination, report the result of that investigation to the Department, and correct that cause of contamination.

   (3)  Wait at least 2 days from the cessation of raw milk sales, or until conformance can reasonably be assured, and then have an approved sampler collect a second sample and submit it to a Pennsylvania-approved dairy laboratory to be tested for the presence of pathogenic bacteria.

   (4)  Following the initial sampling described in the preceding requirement, have an approved sampler collect an additional sample, at least 1 day after the previous sample, and submit it to a Pennsylvania-approved dairy laboratory for testing for the presence of pathogenic bacteria.

   (5)  Refrain from selling raw milk until and unless two consecutive tests, from samples drawn at least 1 day apart, show that raw milk produced at the dairy operation that is the subject of the raw milk permit is free from disease-producing organisms, and the Department reviews these test results and approves the resumption of raw milk sales.

§ 59a.410.  Location of raw milk packaging facilities on the dairy farm.

   (a)  Containers owned by the raw milk permitholder. If raw milk is packaged for sale in containers that are owned by the raw milk permitholder (such as in prepackaged containers for consumer purchase), the dairy farm shall have separate rooms for bottling, single service container storage, and bottle washing, as applicable. A mechanical means of filling and capping bottles shall be utilized for prepackaging, and the closure must protect the pouring lip to its largest diameter.

   (b)  Containers owned by the customer. If raw milk is packaged for sale in containers that are owned by the consumer, the Department will consider a milk room facility as being adequate for the packaging of this raw milk.

§ 59a.411.  Label content review by the Department.

   (a)  Raw milk in containers owned by the raw milk permitholder.

   (1)  General label statements. If raw milk is packed for sale in containers that are owned by the raw milk permit- holder, the labeling on these containers and caps shall be submitted to the Department and approved by the Department prior to use in commerce. The container must be labeled as raw milk, and include the net weight as well as the name and address of the distributor or producer and the words ''Keep Refrigerated.'' It may not be misbranded or contain any false or misleading statements.

   (2)  Consumer advisory for raw animal-derived foods that have not been processed to remove pathogens.

   (i)  In addition to the information described in paragraph (1), the label must contain a consumer advisory statement to notify consumers of the increased risks (particularly to certain highly susceptible populations) associated with the consumption of raw animal-derived foods that have not been processed to remove pathogens. An acceptable notice would be as follows:

Raw milk has not been processed to remove pathogens that can cause illness. The consumption of raw milk may significantly increase the risk of foodborne illness in persons who consume it - particularly with respect to certain highly-susceptible populations such as preschool-age children, older adults, pregnant women, persons experiencing illness, and other people with weakened immune systems.

   (ii)  The Department will consider alternative written means of notification of consumers of the potential risks associated with the consumption of raw milk by highly-susceptible populations.

   (3)  Label requirement:  milk dating.

   (i)  Requirement. The cap of the raw milk container, or the container itself, must be conspicuously and legibly marked in a contrasting color with the designation of the ''sell-by'' date--the month and day of the month after which the raw milk may not be sold or offered for sale. The designation may be numerical--such as ''8-15''--or with the use of an abbreviation for the month, such as ''AUG 15'' or ''AU 15.'' The words ''Sell by'' or ''Not to be sold after'' must precede the designation of the date, or the statement ''Not to be sold after the date stamped above'' must appear legibly on the container. This designation of the date may not exceed 17 days beginning after midnight on the day on which the raw milk was produced.

   (ii)  Prominence of sell-by date on label. The sell-by date must be separate and distinct from any other number, letter or intervening material on the cap or container.

   (iii)  Prohibition. Raw milk may not be sold or offered for sale for human consumption if the raw milk is sold or offered for sale after the sell-by date designated on the container.

   (iv)  Monitoring by the Department.

   (A)  The Department will periodically sample containers of raw milk in the possession of the raw milk permit- holder or a distributor. This sampling may occur at any time before the raw milk is delivered to the customer. The Department will take at least one sample of raw milk from each raw milk permitholder each calendar year.

   (B)  The samples described in clause (A) shall be analyzed by the Department or a Pennsylvania-approved dairy laboratory, to determine whether bacterial test results exceed the bacterial limits for raw milk described in the Raw Milk Testing Schedule and Standards set forth in § 59a.408 (relating to regular testing of raw milk) prior to the expiration of the sell-by date designated on the raw milk container.

   (C)  When two or more samples demonstrate a raw milk permitholder cannot produce raw milk that remains consistently within the bacterial limits referenced in clause (B) through the sell-by date marked on the container, the Department will require a raw milk permit- holder to use a shorter sell-by date specified by the Department. The Department will calculate this revised sell-by date so that bacterial growth in the raw milk will not exceed the referenced bacterial limits within that sell-by period if the raw milk is maintained in accordance with the temperature requirements for raw milk set forth in the Raw Milk Testing Schedule and Standards in § 59a.408.

   (D)  A raw milk permitholder may submit samples to the Department for analysis to obtain approval to resume a 17-day sell-by period for the raw milk sampled. The Department will approve resumption of a 17-day sell-by period when analysis of a sample demonstrates that bacterial growth in the raw milk will not exceed the referenced bacterial limits within that sell-by period if the raw milk is maintained in accordance with the temperature requirements for raw milk set forth in the Raw Milk Testing Schedule and Standards in § 59a.408.

   (b)  Raw milk in customer-owned containers.

   (1)  Container labeling and caps. If raw milk is packed for sale in containers that are owned by the consumer, Departmental review of the labeling on the container or caps is not required. The Department recommends, but does not require, that customer owned containers be clean, food-grade containers of 1 gallon or smaller capacity.

   (2)  Consumer advisory. If raw milk is packed for sale in containers that are owned by the consumer, the raw milk permitholder shall post a consumer advisory at the location where the customer owned containers are filled, or in close proximity to that location, to provide consumers notice of increased risks associated with the consumption of raw animal-derived foods that have not been processed to remove pathogens by certain highly susceptible populations. An acceptable notice would be as described in subsection (a)(2). The Department will consider alternative written means of notification of consumers of the potential risks associated with the consumption of raw milk by highly-susceptible populations.

§ 59a.412.  Inspection, sampling and testing by the Department.

   A raw milk permitholder shall allow the Department and its personnel to inspect the dairy operation that is the subject of the permit, review records, draw samples, conduct tests and take other actions necessary to the Department's performance of its responsibilities under the act, the Food Act or any other applicable statute or regulation. If a raw milk permitholder fails to allow this inspection and sampling by the Department, the Department may take steps to revoke or suspend the raw milk permit.

§ 59a.413.  Enforcement:  Suspension or revocation of a raw milk permit.

   (a)  General. The Department may take action to suspend or revoke a raw milk permit if a permitholder does not comply with the act or this chapter.

   (b)  Procedure.

   (1)  The act requires that the Department provide a raw milk permitholder with at least 5 days' advance written notice of a raw milk permit revocation or suspension. This written notice will be sent by certified mail.

   (2)  If the basis for a proposed raw milk permit suspension or revocation is that pathogenic bacteria have been detected in the raw milk, or foreign substances are present in the raw milk, or any condition exists where consumption of raw milk produced and sold prior to revocation or suspension of the raw milk permit may pose a threat to the health or safety of those persons who consume it, the Department will immediately notify the raw milk permitholder and request that it voluntarily cease all sales of raw milk--without regard to whether the raw milk permitholder has received the 5 days' advance written notice required under the act.

   (i)  If a raw milk permitholder complies with a request that it voluntarily cease raw milk sales, the Department will consider this cooperation a mitigating factor as it determines any penalty or sanction relating to the violation.

   (ii)  If a raw milk permitholder does not choose to comply with a request that it voluntarily cease raw milk sales, the Department will do the following:

   (A)  Apprise the Department of Health and any local health department having jurisdiction with notice of the situation, and recommend these entities take lawful action to ensure that sales of raw milk cease.

   (B)  Consult with the Office of Attorney General regarding whether it should institute legal action to obtain an injunction to prohibit the raw milk sales.

   (C)  Arrange for an administrative hearing before a hearing examiner, if the raw milk permitholder requests a hearing on the proposed permit suspension or revocation.

   (D)  Issue a final adjudication, ordering the suspension or revocation, if the raw milk permitholder does not request a hearing on the proposed permit suspension or revocation.

   (c)  Ownership of raw milk permit. A raw milk permit is and remains the property of the Department--even when it is in the physical custody of the permitholder. If a raw milk permit is suspended or revoked, the person in possession of the raw milk permit shall immediately return or surrender that raw milk permit to the Department. In the case of a permit suspension, the Department will promptly return the raw milk permit to the permit- holder at the end of the suspension period.

§ 59a.414.  Enforcement:  Summary criminal prosecution.

   If a raw milk permitholder violates any provision of the act or this chapter, the Department may file a summary prosecution against a raw milk permitholder for the violation. The violation is graded as a summary offense.

§ 59a.415.  Enforcement:  Injunctions.

   The Department may ask the Attorney General to initiate legal action to enjoin a person from selling raw milk without the required raw milk permit or from violating the act or this chapter. Violations of an injunction can result in fines or imprisonment, or both.

§ 59a.416.  Enforcement:  Seizure, condemnation, denaturing or destruction of raw milk; exclusion from sale.

   (a)  Seizure, condemnation, denaturing or destruction of raw milk. Whenever, in the opinion of the Secretary, a given supply of raw milk or illegally-produced raw milk products is considered unsafe or a menace to public health, the Secretary may seize, condemn, denature or destroy the milk or milk products, without compensation to the owner of the milk or milk products.

   (b)  Excluding milk from sale. The Department may exclude raw milk or illegally-produced raw milk products from sale in either of the following circumstances:

   (1)  The Secretary considers the raw milk or illegally-produced milk products to be unsafe.

   (2)  If a raw milk permitholder violates a provision of the act or this chapter.

Subchapter G.  MISCELLANEOUS PROVISIONS

§ 59a.501.  Interrelatedness with Food Act.

   The subject matter of the act and this chapter overlaps with the subject matter of the Food Act and the regulations promulgated under authority of that statute in Chapter 46 (relating to food code). This chapter does not restrict, prevent or limit the Department or any other government entity from exercising authority under the Food Act or its attendant regulations with respect to milk, milk products, manufactured dairy products or any other foods.

[Pa.B. Doc. No. 09-1402. Filed for public inspection July 31, 2009, 9:00 a.m.]

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