(a) General requirements.
  (1) Plant cleanliness. All rooms in which dairy products are handled, processed or stored, or in which containers, utensils and/or equipment are washed or stored, shall be kept clean, neat and free of evidence of insects and rodents. Only insecticides and rodenticides approved for use by the department and/or registered with the U.S. Environmental Protection Agency (EPA) shall be used for insect and rodent control. Only equipment directly related to processing operations or the handling of containers, utensils, and equipment shall be permitted in the pasteurizing, processing, cooling, condensing, drying, packaging, and bulk milk or milk product storage rooms. All piping, floors, walls, ceilings, fans, shelves, tables and the non-product-contact surfaces of other facilities and equipment shall be clean. No trash, solid waste or waste dry product shall be stored within the milk plant, except in covered containers. Excessive product dust shall be kept under effective control by the use of exhaust and collective systems designed for in-plant dust control. Tailings and materials collected from exhaust collective systems shall not be used for human consumption.
  (2) Surroundings. The adjacent surroundings shall be free from refuse, rubbish, and waste materials to prevent harborage of rodents, insects, and other vermin. The premises shall be kept in a clean and orderly condition, and shall be free from strong or foul odors, or smoke. Construction and maintenance of adjacent plant traffic areas shall be of concrete, asphalt, or similar material to keep dust and mud to a minimum.
  (3) Drainage. A suitable drainage system shall be provided which will allow rapid drainage of all water from plant buildings and driveways, including surface water around the plant and on the premises, and all such water shall be disposed of in such a manner as to prevent a nuisance or health hazard and in compliance with state, district, and local regulations.
(b) Buildings.
  (1) The building or buildings shall be of sound construction and shall be kept in good repair to prevent the entrance or harboring of rodents, birds, insects, vermin, dogs, and cats. All service pipe openings through outside walls shall be sealed around the opening or provided with tight metal collars.
  (2) All openings to the outer air shall be effectively protected by: screening or effective electric screen panels; fans or air curtains which provide sufficient air velocity so as to prevent the entrance of insects; properly constructed flaps where it is impractical to use self-closing doors or air curtains; or any effective combination of the above or by any other method which prevents the entrance of insects. All outer doors shall be tight and self-closing. Screen doors shall open outward. All outer openings shall be rodent-proofed to the extent necessary to prevent the entry of rodents.
  (3) The walls, ceilings, partitions, and posts of rooms in which milk or dairy products are processed, manufactured, handled, packaged, or stored (except dry storage of packaged finished products and supplies) or in which utensils are washed and stored, shall be smooth with material that is light colored, resistant to moisture, and easy to keep clean.
  (4) Floors.
    (A) The floors of all rooms in which milk or dairy products are processed, manufactured, packaged, or stored or in which utensils are washed shall be constructed of tile laid with impervious joint material, concrete, or other equally impervious material. The floors shall be smooth, kept in good repair, graded so that there will be no pools of standing water or milk products after flushing, and all openings to the drains shall be equipped with traps properly constructed and kept in good repair.
    (B) Sound, smooth wood floors which can be kept clean, may be used in rooms where new containers and supplies and packaged finished products are stored.
  (5) Lighting and ventilation.
    (A) Adequate light sources shall be provided (natural, artificial or a combination of both) which furnish at least 20 foot-candles (220 lux) of light in all working areas. This shall apply to all rooms where milk or milk products are handled, processed, packaged, or stored; or where containers, utensils and/or equipment are washed. Dry storage and cold storage rooms shall be provided with at least five foot-candles (55 lux) of light.
    (B) Ventilation in all rooms shall be sufficient to keep them reasonably free of odors and excessive condensation on equipment, walls and ceilings.
    (C) Pressurized ventilating systems, if used, shall have a filtered air intake.
    (D) For milk plants that condense and/or dry milk or milk products, ventilating systems in packaging rooms, where used, shall be separate systems and where possible have the ducts installed in a vertical position.
  (6) Rooms and compartments.
    (A) Pasteurizing, processing, reconstitution, cooling, condensing, drying, and packaging of milk and milk products shall be conducted in a single room, or separate rooms, but not in the same room used for the cleaning of milk cans, portable storage bins, bottles and cases, or the unloading and/or cleaning and sanitizing of milk tank trucks, provided that these rooms may be separated by solid partitioning doors that are kept closed. Handwashing of milk cans, portable storage bins, bottles and cases may be permitted in a single room, provided that these operations are conducted in a manner that precludes contamination of the finished dairy product. Cooling, either plate or tubular, may be done in the room where milk tank trucks are unloaded and/or cleaned and sanitized. Separation/clarification of raw milk may be done in an enclosed room where milk tank trucks are unloaded and/or cleaned and sanitized.
    (B) Coolers and freezers. Coolers and freezers where dairy products are stored shall be clean, dry and maintained at a uniform temperature and humidity to protect the product from deterioration, and minimize the growth of mold. Circulation of air shall maintain uniform temperature and humidity at all times. Coolers and freezers shall be free from rodents, insects, and pests. Shelves shall be kept clean and dry. Refrigeration units shall have provisions for collecting and disposing of condensate.
      (i) Bulk milk and milk products shall be handled and stored to maintain an internal temperature of 45 degrees F or below.
      (ii) Packaged milk and milk products shall be handled and stored to maintain an internal temperature of 41 degrees F or below.
      (iii) Freezers shall be maintained so that frozen food remains frozen at all times.
    (C) Supply rooms. 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. These items stored therein shall be adequately protected from dust, dirt, or other extraneous matter, and so arranged on racks, shelves, or pallets to permit access to the supplies and cleaning and inspection of the room. Insecticides, rodenticides and cleaning compounds shall be properly labeled and segregated, and stored in a separate room or cabinet away from milk, dairy products, ingredients, or packaging supplies.
    (D) Boiler and tool rooms. The boiler and tool rooms shall be separated from other rooms where milk and dairy products are processed, manufactured, packaged, handled, or stored. The rooms shall be kept orderly and reasonably free from dust and dirt.
    (E) Toilet and dressing rooms. Toilet facilities shall be provided and be conveniently located. Toilet rooms may not open directly into any room in which milk and/or milk products are processed, condensed or dried, and stored. Toilet rooms shall be completely enclosed and have tight-fitting, self-closing doors. Dressing rooms, toilet rooms, and fixtures are kept in a clean condition, in good repair and are well ventilated and well lighted. Toilet tissue and easily cleanable covered waste receptacles shall be provided in toilet rooms. All plumbing shall be installed to meet the applicable provisions of the state or local plumbing code. Sewage and other liquid wastes shall be disposed of in a sanitary manner, and non-water-carried sewage disposal facilities shall not be used.
    (F) Starter facilities. Sanitary facilities shall be provided for the handling of starter cultures.
  (7) Handwashing facilities. Handwashing facilities shall be provided, including hot and cold running water, soap or other detergents, and sanitary single-service towels or air dryers. The facilities shall be located in or adjacent to toilet and dressing rooms and also at such other places in the plant as may be essential to the cleanliness of all personnel handling products. Vats for washing equipment or utensils shall not be used as handwashing facilities. Self-closing metal or plastic containers shall be provided for used towels and other wastes.
  (8) Drinking water facilities. Drinking water facilities shall be provided in the plant and shall be conveniently located.
(c) Facilities.
  (1) Water supply.
Cont'd...
(A) Water for milk plant purposes shall be from an adequate supply, properly located, protected, and operated. It shall be easily accessible and of a safe, sanitary quality.
    (B) The water supply shall be approved as safe by the State Water Control Authority and, in the case of individual water systems, complies with the specification outlined in Appendix D of the most current revision of the "Grade A Pasteurized Milk Ordinance" which is adopted by reference in §217.2 of this title (relating to Grade A Pasteurized Milk Ordinance), and the Bacteriological Standards outlined in Appendix G of the most current revision of the "Grade A Pasteurized Milk Ordinance."
    (C) There shall be no cross-connection between the safe water supply and any unsafe or questionable water supply, or any source of pollution through which the safe water supply might become contaminated. A connection between the water supply piping and a make-up tank, such as for cooling or condensing, unless protected by an air gap or effective backflow preventer, constitutes a violation of this requirement. An approved air gap is defined as the unobstructed vertical distance through the free atmosphere of at least twice the diameter of the largest incoming water supply pipe or faucet to the flood level of the vessel or receptacle. The distance of the air gap is to be measured from the bottom of the potable inlet supply pipe or faucet to the top of the effective overflow, i.e., flood level rim or internal overflow, of the vessel. In no case, may the effective air gap be less than one inch (2.54 cm).
    (D) Condensing water for milk or milk product evaporators, and water used to produce vacuum and/or to condense vapors in vacuum heat processing equipment, shall be from a source complying with subparagraph (B) of this paragraph. When approved by the department, water from sources not complying with subparagraph (B) of this paragraph, may be used when the evaporator or vacuum heat equipment is constructed and operated to preclude contamination of such equipment, or its contents, by condensing water or by water used to produce vacuum. Means of preventing such contamination are:
      (i) use of a surface type condenser in which the condensing water is physically separated from the vapors and condensate; or
      (ii) use of reliable safeguards to prevent the overflow of condensing water from the condenser into the evaporator. Such safeguards include a barometric leg extending at least 35 feet vertically from the invert of the outgoing condensing water line to the free level at which the leg discharges, or a safety shutoff valve, located on the water feed line to the condenser, automatically actuated by a control which will shut off the in-flowing water when the water level rises above a predetermined point in the condenser. This valve may be actuated by water, air or electricity, and shall be designed so that failure of the primary motivating power will automatically stop the flow of water into the condenser.
    (E) Condensing water for milk or milk product evaporators, complying with subparagraph (D) of this paragraph, and water reclaimed from milk or milk products may be reused when all necessary means of protection are afforded and it complies with the procedures outlined in Appendix D, Part V of the most current revision of the "Grade A Pasteurized Milk Ordinance."
    (F) New individual water supplies and water supply systems, which have been repaired or otherwise become contaminated, shall be disinfected before being placed in use. The supply shall be made free of the disinfectant by pumping to waste before any sample for bacteriological testing shall be collected.
    (G) Samples for bacteriological testing of individual water supplies shall be taken upon the initial approval of the physical structure, each six months thereafter, and when any repair or alteration of the water supply system has been made. Samples shall be taken by the department and examinations shall be conducted in an official laboratory. To determine if water samples have been taken at the frequency established in this section, the interval shall include the designated six month period plus the remaining days of the month in which the sample is due.
    (H) Current records of water test results are retained by the department.
    (I) A potable water supply, which meets the criteria of this section, may be connected to the product feed line of a steam vacuum evaporator, provided that the water supply is protected at the point of connection by an approved backflow prevention device.
  (2) Air under pressure which is in direct contact with milk and milk products and milk product-contact surfaces.
    (A) Filter media. Air intake and pipeline filters shall consist of fiberglass with a downstream backing dense enough to prevent fiberglass breakoff from passing through cotton flannel, wool flannel, spun metal, electrostatic material, or other equally acceptable filtering media, which are non-shedding and which do not release to the air, toxic volatiles or volatiles which may impart any flavor or odor to the milk or milk product.
    (B) Filter performance. Intake air filter efficiency shall be at least 98% using air cleaner coarse test dust. Final filter efficiency shall be at least 99% as measured by the Dioctylphthalate Fog Method (DOP) test (with a mean particle diameter of 0.3 microns). When commercially sterile air is required, the final filter efficiency shall be at least 99.99% as measured by the DOP test.
    (C) Air supply equipment. The compressing equipment shall be designed to preclude contamination of the air with lubricant vapors and fumes. Oil-free air may be produced by one of the following methods or their equivalent:
      (i) use of a carbon ring piston compressor;
      (ii) use of oil-lubricated compressor with effective provision for removal of any oil vapor by cooling the compressed air; or
      (iii) water-lubricated or non-lubricated blowers. The air supply shall be taken from a clean space or from relatively clean outer air and shall pass through a filter upstream from the compressing equipment. This filter shall be located and constructed so that it is easily accessible for examination and the filter media are easily removable for cleaning or replacing. The filter shall be protected from weather, drainage, water, product spillage, and physical damage.
    (D) Moisture removal equipment. Air under pressure systems in excess of one bar, i.e., 103.5 kPa (15 psi), shall be provided with methods of moisture removal. The removal of moisture may be achieved by condensation and coalescing filtration or absorption, or equivalent, to prevent free water in the system. If it is necessary to cool the compressed air, an after-cooler shall be installed between the compressor and the air storage tank for the purpose of removing moisture from the compressed air.
    (E) Filters and moisture traps. Filters shall be constructed so as to ensure effective passage of air through the filter media only. The coalescing filter and associated traps shall be located in the air pipeline downstream from the compressing equipment, and from the air tank, if one is used. The filter shall be readily accessible for examination, cleaning, and for replacing the filter media. The moisture trap shall be equipped with a petcock or other means for draining accumulated water. When coalescing filters are used, a means shall be provided to measure the differential pressure across the filter. The differential pressure device is required to indicate the need for filter media replacement. All coalescing filter housings shall be provided with a means of removing the condensed liquid from the filtration device. This can be accomplished by an automatic or manual drain installed on the base of the filter housing. The final filter media shall be disposable. The filter media shall be located in the air line upstream from, and as close as possible to, the point of application except that a final filter shall not be required where the compressing equipment is of a fan or blower type and operating at a pressure of less than one (1) bar, i.e., 103.5 kPa (15 psi). Electronic air cleaners utilizing electrostatic precipitation principles to collect particulate matter may be used. Disposable filter media shall not be cleaned and reused.
    (F) Air piping. The air piping from the compressing equipment to the filter and moisture trap shall be readily drainable. A milk or milk product check-valve of sanitary design shall be installed in the air piping, downstream from the disposable media filter, to prevent backflow of milk or milk product into the air pipeline, except that a check-valve shall not be required if the air piping enters the milk or milk product zone from a point higher than the milk or milk product overflow level, which is open to the atmosphere, or is for dry product applications, or for other dry application where liquids are not present. When a check-valve is not required, plastic or rubber or rubber-like tubing and suitable compatible fittings and connections made of plastic or stainless steel may be used between the final filter and the point of application. Air distribution piping and fittings after the final filter shall be of corrosion-resistant materials. Air distribution piping, fittings and gaskets between the discharge of the sanitary check-valve to the processing equipment shall be sanitary piping.
Cont'd...
(3) Culinary steam for milk and milk products. The following methods and procedures will provide steam of culinary quality for use in the processing of milk and milk products.
    (A) Source of boiler feed water. Potable water or water supplies, acceptable to the department, shall be used.
    (B) Feed water treatment. Feed water may be treated, if necessary, for proper boiler care and operation. Boiler feed water treatment and control shall be under the supervision of trained personnel or a firm specializing in industrial water conditioning. Such personnel shall be informed that the steam is to be used for culinary purposes. Pretreatment of feed waters for boilers or steam generating systems to reduce water hardness, before entering the boiler or steam generator by ion exchange or other acceptable procedures, is preferable to the addition of conditioning compounds to boiler waters. Only compounds complying with Title 21, Code of Federal Regulations (CFR), §173.310, may be used to prevent corrosion and scale in boilers, or to facilitate sludge removal. Amounts of the boiler water treatment compounds greater than the minimum necessary for controlling boiler scale or other boiler water treatment purposes shall not be used. No greater amount of steam than necessary shall be used for the treatment and/or pasteurization of milk and milk products. It should be noted that tannin, which is also frequently added to boiler water to facilitate sludge removal during boiler blow-down, has been reported to give rise to odor problems, and should be used with caution. Boiler compounds containing cyclohexylmine, morpholine, octadecylamine, diethylaminoethanol, trisodium nitrilotriacetae, and hydrazine shall not be permitted for use in steam in contact with milk and milk products.
    (C) Boiler operation. A supply of clean, dry saturated steam is necessary for proper equipment operation. Boilers and steam generation equipment shall be operated in such a manner as to prevent foaming, priming, carryover and excessive entrainment of boiler water into the steam. Carryover of boiler water additives can result in the production of milk or milk product off-flavors. Manufacturers' instructions regarding recommended water level and blow-down should be consulted and rigorously followed. The blow-down of the boiler should be carefully watched, so that an overconcentration of the boiler water solids and foaming is avoided. It is recommended that periodic analyses be made of condensate samples. Such samples should be taken from the line between the final steam separating equipment and the point of the introduction of steam into the milk or milk product.
  (4) Disposal of wastes. Dairy wastes shall be properly disposed of from the plant and premises. The sewer system shall have sufficient slope and capacity to readily remove all waste from the various processing operations. Where a public sewer is not available, all wastes shall be properly disposed of in a manner in compliance with local and state regulations. 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 above the floor. Alternatively, waste containers may be kept inside an enclosed, clean, and fly-proof room. Solid wastes shall be disposed of at regular intervals to prevent the unsanitary accumulation of waste.
(d) Equipment and utensils - General construction, repair, and installation.
  (1) All multi-use containers and equipment that milk and milk products come into contact with shall be of smooth, impervious, corrosion-resistant, non-toxic material shall be constructed for ease of cleaning and shall be kept in good repair. All single-service containers, closures, gaskets and other articles that milk and milk products come in contact with shall be non-toxic and shall have been manufactured, packaged, transported and handled in a sanitary manner. Articles intended for single-service use shall not be reused.
  (2) All equipment and piping shall be designed and installed so as 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 in such a manner as to facilitate cleaning and to maintain good housekeeping. All parts or interior surfaces of equipment, pipes (except certain piping cleaned in place) or fittings, including valves and connections, shall be accessible for inspection. Milk and dairy product pumps shall be of a sanitary type and easily dismantled for cleaning or shall be of approved construction to allow effective cleaning in place in accordance with 3-A Sanitary Standards.
  (3) All CIP systems shall comply with the 3-A Sanitary Practices for permanently installed sanitary product, pipelines, and cleaning systems.
  (4) All joints in containers, utensils and equipment shall be flush and finished as smooth as adjoining surfaces, or if the surface is vitreous, it must be continuous. Tile floors are not acceptable in dryers. Joints on equipment coming in contact with dry milk or milk products only or used for hot air piping may be sealed by other acceptable means. Where a rotating shaft is inserted through a surface with which milk or milk products come into contact, the joint between the moving and stationary surfaces shall be close fitting. Grease and oil from gears, bearings, and cables shall be kept out of the milk and milk products. Where a thermometer or temperature sensing element is inserted through a surface with which milk or milk products come into contact a pressure-tight seal shall be provided ahead of all threads and crevices.
  (5) Can washers. Can washers shall have sufficient capacity and ability to discharge a clean, dry can and cover and shall be kept properly timed in accordance with the instructions of the manufacturer. The water and steam lines supplying the washer shall maintain a uniform pressure and be equipped with pressure regulating valves.
  (6) Product storage tanks or vats. Storage tanks or vats shall be fully enclosed or tightly covered and well insulated. The entire interior surface, agitator and all appurtenances shall be accessible for thorough cleaning and inspection. Any opening at the top of the tank or vat including the entrance of the shaft shall be protected against the entrance of dust, moisture, insects, oil, or grease. The sight glasses, if used, shall be sound, clear, and in good repair. Vats which have hanged covers shall be so designed 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 shall be of an approved type and properly installed in accordance with the 3-A Accepted Practices for Supplying Air Under Pressure. Storage tanks or vats intended to hold product for longer than approximately eight hours shall be equipped with refrigeration and/or have insulation. All new storage tanks or vats shall meet the appropriate 3-A Sanitary Standards and shall be equipped with thermometers in good operating order.
  (7) Surface coolers. Surface coolers shall be equipped with hinged or removable covers for the protection of the product. The edges of the fins shall be so designed as to divert condensate on non-product-contact surfaces away from product-contact surfaces. All gaskets or swivel connections shall be leak proof.
  (8) Plate-type heat exchangers. Plate-type heat exchangers shall meet the 3-A Sanitary Standards for Construction and Installation. All gaskets shall be tight and kept in good operating order. Plates shall be opened for inspection by the operator at sufficiently frequent intervals to determine if the equipment is clean and in good repair (e.g. free of dents, holes, broken gaskets and cracks). A cleaning regimen shall be posted to insure cleaning procedures between inspection periods.
  (9) Internal return tubular heat exchangers. Internal return tubular heat exchangers shall meet the 3-A Sanitary Standards for Construction and Installation.
  (10) Pumps. Pumps used for milk and dairy products shall 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.
  (11) New equipment and replacements. New equipment and replacements, including all plastic parts, rubber and rubber-like materials for parts and gaskets having product-contact surfaces, shall meet the 3-A Sanitary Standards. If equipment or replacements are not approved by 3-A Sanitary Standards, such equipment and replacements shall meet the general requirements of this section.
(e) Personnel cleanliness. All employees shall wash their hands before beginning work and upon returning to work after using toilet facilities, eating, smoking, or otherwise soiling their hands. They 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. All persons shall wear clean outer garments while engaged in the handling, processing, storage, transporting, or packaging of dairy products. Clean outer garments shall also be worn by persons handling containers, Cont'd...
utensils, and equipment used for these activities. Adequate hair coverings shall be worn by all persons engaged in receiving, testing, processing, packaging, or handling of dairy products.
(f) Personnel health. No person afflicted with a communicable disease shall be permitted in any room or compartment where milk and milk products are prepared, manufactured, or otherwise handled. No person who has a discharging or infected wound, sore or lesion on hands, arms, or other exposed portion of the body shall work in any dairy processing rooms or in any capacity which brings them into direct contact with associated milk or milk product-contact surfaces. Milk plant operators who have received verifiable and confirmed reports from or about employees who have these conditions and who have handled pasteurized milk or milk products or associated milk or milk product-contact surfaces, shall immediately report these facts to the department. Milk plant employees or applicants to whom a conditional offer of employment has been made shall be instructed by the milk plant that the employee or applicant is responsible to report to the milk plant management, in a manner that allows the milk plant to prevent the likelihood of the transmission of diseases that are transmissible through foods, if the employee or applicant:
  (1) is diagnosed with an illness due to Hepatitis A virus, Salmonella typhi, Shigella species, Norovirus, Staphylococcus aureus, Streptococcus pyogenes, Escherichia coli 0157:H7, enterohemorrhagic Escherichia coli, enterotoxigenic Escherichia coli, Campylobacter jejuni, Entamoeba histolytica, Giardia lamblia, Non-typhoidal Salmonella, Rotovirus, Taenia solium, Yersinia enterocolitica, Vibrio cholerae O1 or other infectious or communicable disease that has been declared by the U.S. Secretary of Health and Human Services (HHS) to be transmissible to others through the handling of food, or has been clearly shown to be transmissible based upon verifiable epidemiological data; or
  (2) is exposed to, or suspected of causing, a confirmed foodborne disease outbreak of one of the diseases specified in paragraph (1) of this subsection, including an outbreak at an event such as a family or communal meal, (e.g., church supper or ethnic festival) because the employee or applicant:
    (A) prepared food implicated in the outbreak; or
    (B) consumed food implicated in the outbreak; or
    (C) consumed food at the event prepared by a person who is infected or ill.
  (3) lives in the same household as a person who attends or works in a day care center, school or similar institution if the institution experiencing a confirmed outbreak of one of the diseases specified in paragraph (1) of this subsection. Similarly, milk plant employees shall be instructed by the milk plant management to report to the milk plant management if the employee, or applicant:
  (4) has a symptom associated with acute gastrointestinal illness such as: Abdominal cramps or discomfort, diarrhea, fever, loss of appetite for three or more days, vomiting, jaundice; or
  (5) has a pustular lesion such as a boil or infected wound that is:
    (A) on the hands, wrists or exposed portions of the arms, unless the lesion is covered by a durable, moisture proof, tight-fitting barrier; or
    (B) on other parts of the body if the lesion is open or draining, unless the lesion is covered by a durable, moisture proof, tight-fitting barrier.
(g) Raw product storage.
  (1) All milk shall be held and processed under conditions and at temperatures that will avoid contamination and rapid deterioration. Raw milk in storage tanks within the dairy plant shall be handled in such a manner as to minimize bacterial increase and shall be maintained at 45 degrees Fahrenheit or lower until processing begins. This does not preclude holding milk at higher temperatures for a period of time, where applicable to particular manufacturing or processing practices.
  (2) The bacteriological quality of commingled raw milk for use in dairy products for manufacturing purposes shall not exceed 500,000 per ml.
  (3) During any consecutive six months, at least four samples of raw milk intended for use in manufactured milk products shall be taken by and examined by the department.
(h) Pasteurization. When pasteurization is required, or when a product is designated "pasteurized," every particle of the milk or milk product shall be subjected to such temperatures and holding periods in properly designed and operated equipment sufficient to ensure proper pasteurization of the product in accordance with the most current revision of the "Grade A Pasteurized Milk Ordinance." Provided, that nothing shall be construed as barring any other process found equivalent to pasteurization for milk and milk products, which has been recognized by FDA as provided in 21 U.S.C. §343(h)(3) of the Federal Food, Drug and Cosmetic Act. Only such FDA recognized processes and no other shall be considered by the department.
(i) Composition and wholesomeness. All necessary precautions shall be taken to prevent contamination or adulteration of the milk or dairy products during manufacturing in accordance with these rules. All substances and ingredients used in the processing or manufacturing of any dairy product shall be subject to inspection and shall be wholesome and practically free from impurities.
(j) Cleaning and sanitizing treatment.
  (1) All multi-use containers and utensils shall be thoroughly cleaned after each use and all equipment shall be thoroughly cleaned at least once each day used, unless the department has reviewed and accepted information, in consultation with FDA, supporting the cleaning of multi-use containers and utensils at frequencies extending beyond one day or 72 hours in the case of storage tanks, or 44 hours in the case of evaporators, which are continuously operated. Approval by the department will be conveyed in writing. Supporting information shall be submitted to and approved by the department prior to initiating the qualification period if required. Any significant equipment or processing changes shall be communicated to the department, and may result in a re-verification of the extended run proposal, if it is determined that the change could potentially affect the safety of the finished milk or milk product(s). The supporting information may include but is not limited to:
    (A) statement of proposal, including desired cleaning frequency;
    (B) product and equipment description;
    (C) intended use and consumers;
    (D) distribution and storage temperatures of product;
    (E) diagram of process of interest;
    (F) process parameters, including temperature and times;
    (G) hazard evaluation and safety assessment; and
    (H) review of equipment for sanitary design.
  (2) When indicated by a hazard evaluation and safety assessment, a plan for initial qualification shall be developed to address identified critical process parameters.
  (3) Storage tanks shall be cleaned when emptied and shall be emptied at least every 72 hours. Records must be available to the department to verify that milk storage in these tanks does not exceed 72 hours. These records shall be available for at least the previous three months or from the time of the last regulatory inspection, whichever is longer. Storage tanks, which are used to store raw milk or milk products or heat-treated milk products longer than 24 hours and silo tanks used for the storage of raw milk or milk products or heat-treated milk products shall be equipped with a seven day temperature recording device complying with the specifications of the most current revision of the Grade A Pasteurized Milk Ordinance.
  (4) Evaporators shall be cleaned at the end of a continuous operation, not to exceed 44 hours, and records must be available to the department to verify that the operation time does not exceed 44 hours. Drying equipment, cloth-collector systems, packaging equipment and multi-use dry milk products and dry whey storage containers shall be cleaned at intervals and by methods recommended by the manufacturer and approved in writing by the department. Such methods may include cleaning without water by use of vacuum cleaners, brushes, or scrapers. After cleaning, such equipment is sanitized by a method approved in writing by the department. Cloth collector systems and all dry product-contact surfaces downstream from the dryer shall be sanitized or purged at intervals and by methods recommended by the manufacturer and approved by the department. Storage bins used to transport dry milk or milk products shall be dry cleaned after each usage and washed and sanitized at regular intervals.
  (5) All milk tank trucks that transport milk and milk products shall be washed and sanitized at a permitted milk plant, receiving station, transfer station, or milk tank truck cleaning facility. The milk tank truck shall be cleaned and sanitized prior to its first use. When the time elapsed after cleaning and sanitizing, and before its first use, exceeds 96 hours, the tank must be re-sanitized. Whenever a milk tank truck has been cleaned and sanitized, as required by the department, it shall bear a tag or a record shall Cont'd...
be made showing the date, time, place and signature or initials of the employee or contract operator doing the work, unless the milk tank truck delivers to only one receiving facility where responsibility for cleaning and sanitizing can be definitely established without tagging. The tag shall be removed at the location where the milk tank truck is next washed and sanitized and kept on file for 15 days.
  (6) Pipelines and/or equipment designed for mechanical cleaning shall meet the following requirements.
    (A) An effective cleaning and sanitizing regimen for each separate cleaning circuit shall be followed.
    (B) A temperature recording device, complying with the most current revision of the Grade A Pasteurized Milk Ordinance, or a recording device which provides sufficient information to adequately evaluate the cleaning and sanitizing regimen which is approved by the department in writing, shall be installed in the return solution line or other appropriate area to record the temperature and time during which the line or equipment is exposed to cleaning and sanitizing solutions. For purposes of this section, recording devices which produce records not meeting the specifications of the most current revision of the "Grade A Pasteurized Milk Ordinance" may be acceptable if:
      (i) the device provides a continuous record of the monitoring of the cleaning cycle time and temperature, cleaning solution velocity or cleaning pump operation and the presence or strength of cleaning chemicals for each cleaning cycle;
      (ii) the record shows a typical pattern of each circuit cleaned, so that changes in the cleaning regimen may be readily detected; or
      (iii) electronic storage of required cleaning records, with or without hard copy printouts, may be acceptable, provided, the electronically generated records are readily available. Electronic records must meet the criteria of this section and those provisions of with the most current revision of the Grade A Pasteurized Milk Ordinance, which are determined to be applicable by the department and FDA. Except that, electronic storage of required cleaning records, with or without hard copy, shall be acceptable, provided the computer and computer generated records are readily available and meet the criteria of this section and Title 21, CFR, Part 11.
(k) Packaging and labeling.
  (1) Containers:
    (A) The size, style, and type of packaging used for dairy products shall be packaged in materials which will cover and protect the quality of the contents during storage and regular channels of trade and under conditions of handling. The weights and shape within each size or style shall be as nearly uniform as is practical.
    (B) 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. In addition, the wrapper shall be resistant to puncturing, tearing, cracking, or breaking under normal conditions of handling, shipping, and storage. When special-type packaging is used, the instructions of the manufacturers shall be followed closely as to its application and methods of closure.
  (2) Packaging and repackaging. Packaging dairy products or cutting and repackaging all styles of dairy products shall be conducted under rigid sanitary conditions. The atmosphere of the packaging rooms, the equipment and packaging material shall be free from mold and bacterial contamination. Methods for checking the level of contamination shall be as prescribed by the most current edition of "Standard Methods for the Examination of Dairy Products" of the American Public Health Association as defined in §217.1 of this title (relating to Definitions).
  (3) Labeling. All commercial bulk packages containing dairy products manufactured under the provisions of this subpart shall be adequately and legibly marked with the name of the product, name and address of processor or manufacturer or other assigned plant identification, lot number, and any other identification as may be required by the department. Consumer packaged products shall be legibly marked with the name of the product, name and address of packer, manufacturer, or distributor.
(l) Storage of finished product.
  (1) Dry storage. The product shall be stored at least 18 inches from the wall in aisles, rows, or sections and lots, in such a manner as to be orderly and easily accessible for inspection. Rooms should be cleaned regularly. Care shall be taken in the storage of any other product foreign to dairy products in the same room, in order to prevent impairment or damage to the dairy product from mold, absorbed odors, or vermin or insect infestation. Control of humidity and temperature shall be maintained at all times to prevent conditions detrimental to the product and container.
  (2) Refrigerated storage. The finished product shall be placed on shelves, dunnage, or pallets and identified. It shall be stored under temperatures that will best maintain the initial quality. The product shall not be exposed to anything from which it might absorb any foreign odors or be contaminated by drippage or condensation.

Source Note: The provisions of this §217.74 adopted to be effective July 4, 2010, 35 TexReg 3038