Subchapter B. STANDARDS FOR MILK AND MILK PRODUCTS

§ 59.51. Rule.

 (a)  All raw milk for pasteurization and all pasteurized milk and milk products shall be produced, processed, and pasteurized to conform with the chemical, bacteriological, and temperature standards and the sanitation requirements of this chapter.

 The following table sets forth the chemical, bacteriological and temperature standards for milk and milk products:

   The provisions of this §  59.52 amended under the act of July 2, 1935 (P. L. 589, No. 12) (31 P. S. § §  645—660f).

   The provisions of this §  59.52 amended September 5, 1986, effective September 6, 1986, 16 Pa.B. 3285; amended December 13, 1996, effective December 14, 1996, 26 Pa.B. 5950. Immediately preceding text appears at serial pages (217612) to (217614).

   This section cited in 7 Pa. Code §  59.22 (relating to milk dating).

SANITATION REQUIREMENTS APPLICABLE TO PRODUCTION OF MILK FOR PASTEURIZATION

§ 59.101. Abnormal milk.

 (a)  Cows which show evidence of the secretion of abnormal milk in one or more quarters based on bacteriological, chemical or physical examination and cows which have been treated with or have consumed chemical, medicinal or radioactive agents which are capable of being secreted in the milk and which in the judgment of the Secretary may be deleterious to human health shall be milked last or with separate equipment. The milk may not be offered for sale for human consumption.

 (b)  Milk from cows being treated with medicinal agents may not be offered for sale for periods recommended by the attending veterinarian or as indicated on the package label of the medicinal agent.

 (c)  Milk from cows treated with or exposed to insecticides not approved for use on dairy cattle by the United States Environmental Protection Agency may not be offered for sale until the milk has been tested and found acceptable by the Secretary.

 (d)  Bloody, stringy, off-color milk or milk abnormal to the sight or odor shall be so handled and disposed of as to preclude the infection of other cows and the contamination of the utensils.

 (e)  Cows secreting abnormal milk shall be milked last or with separate equipment which effectively prevents contamination of the wholesome supply.

 (f)  Equipment, utensils and containers used for the handling of abnormal milk may not be used for the handling of milk to be offered for sale unless they are first cleaned and effectively sanitized.

 (g)  The Wisconsin Mastitis Test may be used as a screening test. A test of 18mm or higher shall be considered to indicate abnormal milk and shall require confirmation by the Direct Microscopic Somatic Cell Count Method or an equivalent method according to the current edition of Standard Methods for the Examination of Dairy Products.

 (h)  Poultry litter and recycled animal body discharges may not be fed to lactating dairy animals.

   The provisions of this §  59.101 amended September 5, 1986, effective September 6, 1986, 16 Pa.B. 3285. Immediately preceding text appears at serial page (103217).

 A milking barn, stable or parlor shall be provided on all dairy farms in which the milking herd is housed during milking time operations. The areas used for milking purposes shall meet the following requirements:

   (1)  Floors, feed troughs and gutters, if present, shall be constructed of good quality concrete or equally impervious material. Floors shall be constructed so as to be easily cleaned—brushed surfaces are permitted—and shall be graded to drain.

   (2)  Walls and ceilings shall be finished with wood, tile, smooth-surfaced concrete, cement plaster, brick or other equivalent materials with light-colored surfaces. Walls, partitions, doors, shelves, windows, and ceilings shall be kept in good repair, and surfaces shall be refinished whenever wear or discoloration is evident. Whenever feed is stored overhead, ceilings shall be constructed to prevent the sifting of chaff and dust into the milking barn, stable, or parlor. If a hay opening is provided from the loft into the milking portion of the barn, each opening shall be provided with a dust-tight door which shall be kept closed during milking operations.

   (3)  Separate pens shall be provided for bulls, horses, and calves. These areas shall be separated by tight partitions, from the milking area. Such portion of the barn not so separated shall comply with this section.

   (4)  The milking barn shall be provided with natural or artificial light to insure that all surfaces and particularly the working areas will be plainly visible. The equivalent of at least 10 foot-candles of light in all working areas shall be provided.

   (5)  Air circulation shall be sufficient to minimize odors and to prevent condensation upon walls and ceilings.

   (6)  There shall be no overcrowding by the presence of calves, cows, or other barnyard animals in walks or feed alleys. Inadequate ventilation and excessive odors may also be evidence of an overcrowded barn.

   (7)  A dust-tight partition, provided with doors that are kept closed except when in actual use, shall separate the milking portion of the barn from any feed room or silo in which feed is ground or mixed or in which sweet feed is stored. Feed may be stored in the milking portion of the barn only in such manner as will not increase the dust content of the air, attract flies, or interfere with cleaning of the floor—as in covered, dust-tight boxes or bins. Open feed dollies or carts may be used for distributing feed, but not storing feed, in the milking barn.

 The interior of the milking barn, stable, or parlor shall meet the following standards of cleanliness:

   (1)  The interior of such facilities shall be kept clean.

   (2)  Leftover feed in feed mangers shall appear fresh and shall not be wet or soggy.

   (3)  The bedding material, if used, shall not contain more manure than has accumulated since the previous milking.

   (4)  Outside surfaces of pipeline systems located in the milking barn, stable, or parlor shall be reasonably clean.

   (5)  Gutter cleaners shall be reasonably clean.

   (6)  All pens, calf stalls, and bull pens—if not separated from the milking barn, stable, or parlor—shall be clean.

   (7)  Swine and fowl shall be kept out of the milking barn.

 Cowyards shall meet the following requirements:

   (1)  The cowyard, which is the enclosed or unenclosed area adjacent to the milking barn in which the cows may congregate, including cattle housing areas and feed lots, shall be graded and drained; depressions and soggy areas shall be filled; cow lanes shall be reasonably dry.

   (2)  Approaches to the barn door and surroundings of stock watering and feeding stations shall be solid to the footing of the animal.

   (3)  Wastes from the barn or milkhouse shall not be allowed to pool in the cowyard. Cowyards which are muddy due to recent rains should not be considered in violation of this paragraph.

   (4)  Manure, soiled bedding, and waste feed shall not be stored or permitted to accumulate in cowyards in such a manner as to permit the soiling of cows’ udders and flanks. Cattlehousing areas—stables without stanchions such as loose-housing stables, pen stables, resting barns, holding barns, loafing sheds, wandering sheds, and free-stall housing—will be considered a part of the cowyard. Manure packs shall be solid to the footing of the animal.

   (5)  Cowyards shall be kept reasonably free of cattle droppings. Cattle droppings shall not be allowed to accumulate in piles that are accessible to the animals.

 The milkhouse or room shall meet the following construction requirements:

   (1)  A separate milkhouse of sufficient size and conveniently located shall be provided for the cooling, handling, and storing of milk containers and utensils except as provided for in §  59.112 (relating to utensils and equipment—storage).

   (2)  The floors of all milkhouses shall be constructed of good quality concrete—float finish permissible; equally impervious tile; brick laid closely with impervious material; or metal surfacing with impervious joints or of other material the equivalent of concrete, and maintained free of breaks, depressions, and surface peelings.

   (3)  The floor shall slope to drain so that there are no pools of standing water. The joints between the floor and the walls shall be watertight.

   (4)  The liquid wastes shall be disposed of in a sanitary manner; all floor drains shall be accessible and shall be trapped if connected to a sanitary sewer.

   (5)  Walls and ceilings shall be constructed of smooth dressed lumber or similar material, well painted with a light-colored washable paint, and shall be in good repair. Surfaces and joints shall be tight and smooth. Sheet metal, tile, cement block, brick, concrete, cement plaster, or similar materials of light color may be used; the surfaces and joints shall be smooth. Impervious materials shall be used to a height of at least 18 inches above the floor.

   (6)  A minimum of 20 foot-candles of light shall be provided at all working areas from natural or artificial light, or both, for milkhouse operations.

   (7)  Windows and solid doors shall be closed during dusty weather.

   (8)  The milkhouse shall be adequately ventilated to minimize odors and condensation on floors, walls, ceilings, and clean utensils.

   (9)  Vents, if installed, and lighting fixtures shall be installed in a manner to preclude the contamination of bulk milk tanks or clean utensil storage areas.

   (10)  The milkhouse shall be used for no other purpose than milkhouse operations.

   (11)  There shall be no direct opening into any barn, stable, or room used for domestic purposes; except that an opening between the milkhouse and milking barn, stable, or parlor is permitted when a tight-fitting self-closing solid door hinged to be single- or double-acting is provided.

   (12)  A vestibule, if used, shall comply with the applicable milkhouse construction requirements.

   (13)  The transfer of milk from a bulk-holding/cooling tank to a transport tank shall be through a hose port located in the milkhouse wall. The port shall be fitted with a tight door, which shall be in good repair. It shall be kept closed except when the port is in use. An easily cleanable surface shall be constructed under the hose port, adjacent to the outside wall, sufficiently large to protect the milk hose from contamination.

   (14)  Water under pressure shall be piped into the milkhouse.

   (15)  Each milkhouse shall be provided with facilities for heating water in sufficient quantity and to such temperatures for the effective cleaning of all equipment and utensils.

   (16)  The milkhouse shall be equipped with a wash-and-rinse vat having at least two compartments. Each compartment shall be of sufficient size to accommodate the largest utensil or container used. The cleaning-in-place vat for milk pipelines and milk machines may be accepted as one part of the two-compartment vat; provided that the cleaning-in-place station rack in or on the vat and the milking machine inflations and appurtenances are completely removed from the vat during the washing, rinsing, and sanitizing of other utensils and equipment.

   (17)  A suitable shelter shall be provided for a transportation truck used for cooling and storing milk. Such shelter shall be adjacent to, but not a part of, the milkroom and shall comply with the requirements of the milkroom with respect to construction, light, drainage, insect and rodent control, and general maintenance.

 The milkhouse or room shall meet the following cleanliness requirements:

   (1)  The milkroom structure, equipment, and other milkroom facilities used in its operation or maintenance shall be clean at all times.

   (2)  Incidental articles such as desks, refrigerators, and storage cabinets may be in the milkroom; provided that they are kept clean, that ample space is available to conduct the normal operations in the milkroom, and that they will not cause contamination of the milk.

   (3)  Vestibules, if provided, shall be kept clean.

   (4)  Animals and fowl shall be kept out of the milkroom.

 The waste shall be inaccessible to flies and shall not pollute the soil surface or contaminate any water supply. Toilet facilities shall meet the following standards:

   (1)  There shall be at least one flush toilet connected to a public sewer system or to an individual sewage-disposal system or a chemical toilet, earth pit privy, or other type of privy. Such sewage systems shall be constructed and operated in accordance with the requirements of the State agency responsible for construction and operation thereof.

   (2)  A toilet or privy shall be convenient to the milking barn and the milkroom. There shall be no evidence of human defecation or urination about the premises.

   (3)  No toilet or privy shall open directly into the milkroom.

   (4)  The toilet room, including all fixtures and facilities, shall be kept clean and free of flies and odors.

   (5)  When flush toilets are used, doors to toilet rooms shall be tight and self-closing. All outer openings in toilet rooms shall be screened or otherwise protected against the entrance of flies.

   (6)  Vents of earth pits shall be screened.

 The water supply shall meet the following requirements:

   (1)  Water for milkhouse and milking operation shall be from a supply properly located, protected, and operated and shall be easily accessible, adequate, and of a safe and sanitary quality.

   (2)  The water supply shall contain a Most Probable Number of Coliform Organisms (MPN) of less than 2.2/100 ml by the multiple tube fermentation method or less than 1/100 ml by the membrane filter technique.

   (3)  No cross-connection shall exist between a safe water supply and any unsafe or questionable water supply or any other source of pollution.

   (4)  There shall be no submerged inlets through which a safe water supply may be contaminated.

   (5)  The well or other source of water shall be located and constructed in such a manner that neither underground nor surface contamination from any sewerage system, privy, or other source of pollution can reach such water supply.

   (6)  New individual water supplies and water supply systems which have been repaired or which otherwise become contaminated shall be thoroughly 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.

   (7)  All containers and tanks used in the transportation of water shall be sealed and protected from possible contamination. These containers and tanks shall be subjected to a thorough cleaning and a bacteriological treatment prior to filling with potable water to be used at the dairy farm. To minimize the possibility of contamination of the water during its transfer from the potable tanks to the elevated or groundwater storage at the dairy farm, a suitable pump, hose, and fittings shall be provided. When the pump hose and fittings are not being used, the outlets shall be capped and stored in a suitable dustproof/enclosure so as to prevent their contamination. The storage tank at the dairy farm shall be constructed of impervious material provided with a dustproof and rainproof cover and provided with an approved type vent and roof hatch. All new reservoirs or reservoirs which have been cleaned shall be disinfected prior to placing them into service.

   (8)  Samples for bacteriological examination shall be taken upon the initial approval of the physical structure, when any repair or alteration of the water supply system has been made, and at least every 3 years; provided that water supplies with buried well casing seals installed prior to August 7, 1982, shall be tested at intervals no greater than 6 months apart. Whenever such samples indicate either the presence of bacteria of the coliform group or whenever the well casing, pump, or seal need replacing or repair, the well casing and seal shall be brought above the ground surface and shall comply with all other applicable construction criteria of this section; provided that when water is hauled to the dairy farm, such water shall be sampled for bacteriological examination at the point of use and submitted to a laboratory each month. Bacteriological examinations shall be conducted in a laboratory acceptable to the Secretary.

   (9)  Current records of water tests shall be retained on file by the permit holder.

 Construction of utensils and equipment shall meet the following requirements:

   (1)  All multiuse containers, equipment, and utensils which are exposed to milk or milk products or from which liquids may drip, drain, or be drawn into milk or milk products shall be made of smooth impervious, nonabsorbent, safe materials of the following types:

     (i)   Stainless steel of the AISI (American Iron and Steel Institute) 300 series.

     (ii)   Equally corrosion-resistant, non-toxic metal.

     (iii)   Heat-resistant glass.

     (iv)   Plastic or rubber and rubberlike materials which are relatively inert; are resistant to scratching, scoring, decomposition, crazing, chipping, and distortion under normal use conditions; are nontoxic; are fat resistant; are relatively nonabsorbent; are relatively insoluble; do not release component chemicals or impart flavor or odor to the product; and maintain their original properties under repeated use conditions.

   (2)  Single-service articles shall have been manufactured, packaged, transported, and handled in a sanitary manner and shall comply with the applicable requirements of § §  59.210 and 59.211 (relating to sanitary piping; and construction and repair of containers and equipment).

   (3)  Articles intended for single-service use shall not be reused.

   (4)  All containers, equipment, and utensils shall be free of breaks and corrosion.

   (5)  All joints in such containers, equipment, and utensils shall be smooth and free from pits, cracks, or inclusions.

   (6)  Cleaned-in-place milk pipelines and return-solution lines shall be self-draining. If gaskets are used, they shall be self-positioning and of material meeting specifications described in paragraph (1)(iv) and shall be of such design, finish, and application as to form a smooth, flush-interior surface. If gaskets are not used, all fittings shall have self-positioning faces designed to form a smooth, flush-interior surface. All interior surfaces of welded joints in pipelines shall be smooth and free of pits, cracks, and inclusions.

   (7)  Detailed plans for cleaned-in-place pipeline systems shall be submitted to the Secretary for written approval prior to installation. No alteration or addition shall be made to any milk pipeline system without prior written approval of the Secretary.

   (8)  Strainers, if used, shall be of perforated metal design or so constructed as to utilize single-service strainer media.

   (9)  All milking machines including heads, milk claws, milk tubing, and other milk-contact surfaces shall be able to be cleaned and inspected easily.

   (10)  Milk cans shall have umbrella-type lids.

   (11)  Farm holding/cooling tanks, welded sanitary piping, and transportation tanks shall comply with the applicable requirements of § §   59.210 and 59.211. Milk handling equipment shall be constructed and installed to conform with 3A Standards.

 Utensils and equipment shall meet the following cleaning requirements: the product contact surfaces of all multiuse containers, equipment, and utensils used in the handling, storage, or transportation of milk shall be cleaned after each usage.

 All product contact surfaces of multiuse containers, utensils and equipment used in the handling, storage or transportation of milk are sanitized before each usage by one of the following methods or by any method which has been demonstrated to be equally effective:

   (1)  Complete immersion in hot water at a temperature of at least 170°F (77°C) for at least 5 minutes, or exposure to a flow of hot water at a temperature of at least 170° F (77° C) as determined by use of a suitable accurate thermometer at the outlet for at least 5 minutes.

   (2)  Complete immersion for at least 1 minute in or exposure for at least one minute to a flow of a chemical sanitizer of acceptable strength. All product-contact surfaces shall be wetted by the sanitizing solution, and piping so treated shall be filled. Sanitizing sprays may be used.

 Utensils and equipment shall meet the following storage requirements:

   (1)  All milk containers, utensils, and equipment—including milking machine vacuum hoses—shall be stored in the milkhouse on racks until used. Pipeline milking equipment—such as milker claw, inflations, weigh jars, meters, milk hoses, milk receivers, and milk pumps which are designed for mechanical cleaning—may be mechanically cleaned, sanitized, and stored in the milking barn or parlor provided this equipment is designed, installed, and operated to protect the product and solution contact surface from contamination at all times. Some of the parameters to be considered in determining protection are: proper location of equipment, proper drainage of equipment, and adequate and properly located lighting and ventilation. The milking stable or parlor must be used only for milking. Concentrates may be fed in the stable during milking, but the stable may not be used for housing cattle. When manual cleaning of product contact surfaces is necessary, the cleaning shall be done in the milkhouse.

   (2)  Means shall be provided to effect complete drainage of equipment when such equipment cannot be stored to drain freely.

   (3)  Clean cans or other containers shall be stored in the milkhouse within a reasonable time after delivery to the dairy farm.

   (4)  Strainer pads, gaskets, and similar single service articles shall be stored in a suitable container or cabinet in original container and protected against contamination.

 After sanitization, all containers, utensils, and equipment shall be handled in such manner as to prevent contamination of any product-contact surface.

   (1)  Sanitized product-contact surfaces, including farm cooling tank openings and outlets, shall be protected against contact with unsanitized equipment and utensils, hands, clothing, splash, condensation, and other sources of contamination.

   (2)  Any sanitized product-contact surface which has been otherwise exposed to contamination shall be cleaned and sanitized before being used.

 Milking practices shall meet the following requirements:

   (1)  Milking shall be done in a milking barn, stable, or parlor.

   (2)  Brushing shall be completed prior to milking.

   (3)  Flanks, bellies, tails, and udders shall be clipped as often as necessary to facilitate cleaning of these areas and shall be free from dirt. The hair on the udders shall be of such length that it is not incorporated with the teat in the inflation during milking.

   (4)  Udders and teats of all milking cows shall be cleaned and treated with a sanitizing solution and shall be relatively dry just prior to milking.

   (5)  Wet hand milking is prohibited.

 Surcingles, milk stools, and antikickers shall meet these requirements:

   (1)  Milk stools shall not be padded and shall be constructed to be easily cleaned.

   (2)  Milk stools, surcingles, and antikickers shall be kept clean and shall be stored above the floor in a clean place in the milking barn, stable, parlor or milkhouse when not in use.

 Protection from contamination requires compliance with the following:

   (1)  Equipment and operations shall be so located within the milking barn and milkhouse as to prevent overcrowding and contamination of cleaned and sanitized containers, equipment and utensils by splash, condensation, or manual contact.

   (2)  During milking, pipelines and equipment used to contain or conduct milk shall be effectively separated from tanks or circuits containing cleaning or sanitizing solutions.

   (3)  All milk which has overflowed, leaked, been spilled, or been improperly handled shall be discarded.

   (4)  All product-contact surfaces of containers, equipment, and utensils shall be covered or otherwise protected to prevent the access of insects, dust, condensation, and other contamination. All openings, including valves and piping attached to milk storage and transport tanks, pumps or vats, shall be capped or otherwise properly protected.

   (5)  The receiving receptacle shall be raised above the floor as on a dolly or cart or placed at a distance from the cows to protect it against manure and splash when milk is poured or strained in the milking barn. Such receptacle shall have a tight-fitting cover which shall be closed except when milk is being poured.

   (6)  Each pail or container of milk shall be transferred immediately from the milking barn, stable, or parlor to the milkhouse.

   (7)  Pails, cans, and other equipment containing milk shall be properly covered during transfer and storage.

   (8)  Whenever air under pressure is used for the agitation or movement of milk or is directed at a milk-contact surface, it shall be free of oil, dust, rust, excessive moisture, extraneous materials and odor.

   (9)  Antibiotics and medicinals shall be stored in such a manner that they cannot contaminate the milk or milk product-contact surfaces of the equipment, containers, or utensils.

 The following hand-washing facilities are required:

   (1)  Hand-washing facilities shall be located in the milkhouse and in or convenient to the milking barn, stable, parlor or flush toilet.

   (2)  Hand-washing facilities include soap or detergent, hot and cold or warm running water, individual sanitary towels and a readily accessible lavatory fixture. Utensil wash and rinse vats shall not be considered as hand-washing facilities.

 All persons shall meet the following requirements:

   (1)  Hands shall be clean and dried with an individual sanitary towel immediately before milking, before performing any milkhouse function, and immediately after the interruption of any of these activities.

   (2)  Milkers and milk haulers shall wear clean outer garments while milking or handling milk, milk containers, utensils, or equipment.

 Milk shall be cooled in accordance with the following requirements:

   (1)  Can milk shall be promptly cooled to 50°F or lower and maintained at that temperature or less until delivery to the milk plant within 30 hours of initial milking.

   (2)  Milk, if not cooled, shall be delivered to the milk plant within 2 hours after milking.

   (3)  Bulk milk shall be cooled to 40°F within 2 hours after milking. Cooled milk shall not be allowed to rise above a temperature of 50°F by subsequent addition of milk to bulk tank and shall be delivered to milk plant within 66 hours of the initial milking.

   (4)  Bulk tank milk shall be cooled to 40°F or lower at time of pick-up.

   (5)  Transshipment of milk from plant to plant shall be acceptable only if received at a temperature of 45°F or less.

   (6)  Agitation and refrigeration on all farm bulk milk cooling and holding tanks shall be automatically controlled, except as provided for in paragraph (7). Automatic controls shall consist of an interval timer to require agitation of the milk for a minimum period of two minutes in every 60-minute interval and refrigeration to maintain mixed milk temperature between 32°F and 40°F.

   (7)  In lieu of automatic refrigeration controls, as provided for in paragraph (6), an accurate 48-hour recording thermometer shall be installed to provide a continuous and true record of milk temperature. Each temperature recording chart shall be dated and signed by the approved sampler, filed chronologically in the milkhouse for not less than 6 months, and readily accessible for regulatory review.

   (8)  Recirculated cold water which is used in plate or tubular coolers or heat exchangers shall be from a safe source and protected from contamination. Such water shall be tested semiannually and shall comply with the bacteriological standards cited in §  59.108 (relating to water supply).

 Vehicles used to transport milk shall meet the following requirements:

   (1)  Vehicles used to transport milk from the dairy farm to the milk plant or receiving station shall be constructed and operated to protect their contents from sun, freezing and contamination.

   (2)  Vehicles shall have bodies with solid enclosures and tight, solid doors.

   (3)  Vehicles shall be kept clean, inside and out.

   (4)  No substance capable of contaminating the milk shall be transported with the milk.

 Effective measures shall be taken to prevent the contamination of milk, containers, equipment, and utensils by insects and rodents and by chemicals used to control such vermin. This section will be deemed to be satisfied when the following provisions are met:

   (1)  Surroundings shall be kept neat, clean, and free of conditions which might harbor or be conducive to the breeding of insects and rodents. During fly season, manure shall be:

     (i)   Spread directly on the fields;

     (ii)   Stored for not more than 4 days in a pile on the ground surface and then spread on the fields;

     (iii)   Stored for not more than 7 days in an impervious-floored bin or on an impervious-curbed platform and then spread;

     (iv)   Stored in a tight-screened and trapped manure shed;

     (v)   Effectively treated with larvicides; or

     (vi)   Disposed of in any other manner which controls insect breeding.

   (2)  Manure packs in loafing areas, stables without stanchions, pen stables, resting barns, wandering sheds and free-stall housing shall be properly bedded and managed to prevent fly breeding.

   (3)  Milk rooms shall be free of insects and rodents.

   (4)  Milk rooms shall be effectively screened or otherwise protected against the entrance of vermin.

   (5)  Outer milkhouse doors shall be tight and self-closing. Screen doors shall open outward.

   (6)  Effective measures shall be taken to prevent the contamination of milk, containers, utensils, and equipment by insects and rodents and by chemicals used to control such vermin. Insecticides and rodenticides not approved for use in the milkhouse shall not be stored in the milkhouse.

   (7)  Only insecticides and rodenticides approved for use by the Secretary or registered with the United States Environmental Protection Agency shall be used for insect and rodent control.

   (8)  Insecticides and rodenticides shall be used only in accordance with manufacturer’s label directions and shall be used so as to prevent the contamination of milk, milk containers, equipment, utensils, feed and water.

   This section cited in 7 Pa. Code §  59.31 (relating to inspection of dairy farms); and 7 Pa. Code §  59.302 (relating to raw milk).

SANITATION AND PROCEDURE REQUIREMENTS APPLICABLE
TO THE HANDLING AND PROCESSING OF PASTEURIZED MILK
AND MILK PRODUCTS (MILK PLANT)

§ 59.201. Floors—construction.

 (a)  The floors of all rooms in which milk is handled, processed, or stored or in which milk containers or utensils are washed shall be constructed of good quality concrete or equally impervious tile or brick laid closely with impervious joint material, metal surfacing with impervious joints, or other material which is the equivalent of good quality concrete. The floors of storage rooms for dry ingredients or packaging material may be constructed of tightly joined wood.

 (b)  The floor surface shall be smooth and sloped, so that there are no pools of standing water after flushing; and the joints between the floor and the walls shall be impervious.

 (c)  The floors shall be provided with trapped drains. Cold-storage rooms used for storing milk and milk products need not be provided with floor drains when the floors are sloped to drain to one or more exits. Storage rooms for dry ingredients or packaging materials need not be provided with drains.

 (a)  Walls and ceilings shall be finished with smooth, washable, light-colored painted wood, tile, smooth-surface concrete, cement plaster, brick or equivalent materials.

 (b)  Walls, partitions, windows, and ceilings shall be kept in good repair and refinished as often as the finish wears off or becomes discolored.

 (a)  All openings to the outer air shall be effectively protected by:

   (1)  Screening;

   (2)  Effective electric screen panels;

   (3)  Fans or air curtains which provide sufficient air velocity so as to prevent the entrance of flies;

   (4)  Properly constructed flaps where it is impractical to use self-closing doors or air curtains; or

   (5)  Any effective combination of methods listed in paragraphs (1)—(4) or by any other method which prevents the entrance of flies.

 (b)  All outer doors shall be tight and self-closing. Screen doors shall open outward.

 (c)  All outer openings shall be rat-proofed to the extent necessary to prevent the entry of rodents.

 (a)  Adequate light sources shall be provided—natural or artificial, or both—which furnish at least 20 foot-candles of light in all working areas. This shall apply to all rooms where milk or milk products are handled, processed, or stored or where utensils, containers, or equipment are washed. Dry storage and cold storage rooms shall be provided with at least five foot-candles 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.

 (a)  Pasteurizing, processing, cooling and packaging shall be conducted in a single room, but not in the same room used for the cleaning of milk cans, bottles, and cases or the unloading or cleaning and sanitizing of milk tank trucks; provided that, in a receiving station, cooling may be done in the room where milk tank trucks are unloaded or cleaned and sanitized.

 (b)  All bulk milk storage tanks shall be vented into a room used for pasteurization, processing, cooling or packaging operations or into a storage tank gallery room, provided that vents located elsewhere which are adequately equipped with air filters so as to preclude the contamination of the milk shall be considered satisfactory.

 (c)  Solid doors installed in required partitions shall be self-closing.

 (d)  Facilities for the cleaning and sanitizing of milk tank trucks shall be properly equipped for manual or mechanical operations. When such facilities are not provided on the plant premises, these operations shall be performed at a receiving station, transfer station, or separate tank washing installation.

 (e)  Rooms in which milk or milk products are handled, processed, or stored or in which milk containers, utensils, and equipment are washed or stored shall not open directly into any stable or any room used for domestic purposes.

 (f)  All rooms shall be of sufficient size for their intended purposes.

 (a)  Suitable toilet facilities shall be provided.

 (b)  Toilet rooms shall not open directly into any room in which milk or milk products are processed.

 (c)  Toilet rooms shall be completely enclosed and have tight-fitting self-closing doors.

 (d)  Dressing rooms, toilet rooms, and fixtures shall be kept in a clean condition, in good repair, and well ventilated and well lighted.

 (e)  Toilet tissue and easily cleanable covered waste receptacles shall be provided in toilet rooms.

 (f)  All plumbing shall be installed to meet the applicable provisions of the State or local plumbing code.

 (g)  Sewage and other liquid wastes shall be disposed of in a sanitary manner.

 (h)  Non-water-carried sewage disposal facilities shall not be used.

 (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, it shall contain a Most Probable Number of Coliform Organisms (MPN) of less than 2.2/100 ml by the multiple tube fermentation technique or less than 1/100 ml by the membrane filter technique.

 (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 subsection.

 (d)  Condensing water for milk evaporators, and water used to produce a vacuum or to condense vapors in vacuum heat processing equipment shall be from a source complying with subsection (b); provided that, when approved by the Secretary, water from sources not complying with subsection (b) 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 a vacuum. Means of preventing such contamination are either of the following:

   (1)  Use of a surface type condenser in which the condensing water is physically separated from the vapors and condensates.

   (2)  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 inflowing 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 all milk evaporators complying with subsection (b) and water reclaimed from milk or milk products may be reused when all necessary means of protecting are afforded and it has been inspected and approved by the Secretary’s representative.

 (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 is 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. Bacteriological examinations shall be conducted in a laboratory acceptable to the Secretary.

 (h)  Current records of water tests shall be kept on file by the permittee.

 (a)  Convenient hand-washing facilities shall be provided, including hot and cold or warm running water, soap and individual sanitary towels or other approved hand-drying devices.

 (b)  Hand-washing facilities shall be convenient to all toilets and to all rooms in which milk plant operations are conducted.

 (c)  Hand-washing facilities shall be kept in a clean condition and in good repair.

 (d)  Steam-water mixing valves and vats for washing bottles, cans and similar equipment shall not be used as hand-washing facilities.

 (a)  Only equipment directly related to processing operations or the handling of containers, utensils, and equipment is permitted in the pasteurizing, processing, cooling, packaging and bulk milk storage rooms.

 (b)  All piping, floors, walls, ceilings, fans, shelves, tables and the non-product-contact surfaces of other facilities and equipment shall be clean.

 (c)  No trash or solid waste shall be stored within the plant, except in covered containers. Waste containers at the packaging machine or bottle washer may be uncovered during operation of such equipment.

 (d)  All rooms in which milk and milk products are handled, processed, or stored or in which containers, utensils, or equipment are washed or stored shall be kept clean, neat, and free of evidence of insects and rodents.

 (a)  All sanitary piping, fittings, and connections which are exposed to milk or milk products, or from which liquids may drip, drain or be drawn into milk products, shall consist of smooth, impervious, corrosion-resistant, nontoxic, easily cleanable material.

 (b)  All sanitary piping, connections and fittings shall consist of any of the following:

   (1)  Stainless steel of the AISI (American Iron and Steel Institute) 300 series.

   (2)  Equally corrosion-resistant metal which is nontoxic and nonabsorbent.

   (3)  Heat-resistant glass. Provided: that plastic or rubber and rubberlike materials which are relatively inert and resistant to scratching, scoring, decomposition, crazing, chipping and distortion under normal use conditions; which are nontoxic, fat resistant and relatively nonabsorbent; which do not impart flavor or odor to the products; and which maintain their original properties under repeated use conditions may be used for gaskets, sealing applications and short flexible takedown jumpers or connections where flexibility is required for essential or functional reasons.

 (c)  Sanitary piping, fittings and connections shall be designed to permit easy cleaning, shall be kept in good repair and free of breaks or corrosion, and shall contain no dead ends of piping in which milk may collect.

 (d)  All interior surfaces of demountable piping—including valves, fittings and connections—shall be designed, constructed, and installed to permit inspection and drainage.

 (e)  All cleaned-in-place milk pipelines and return-solution lines shall be rigid, self-draining, and so supported to maintain uniform slope and alignment.

   (1)  Return solution lines shall be constructed of material meeting the specifications of subsection (b). If gaskets are used, they shall be self-positioning; of material meeting the specifications outlined in subsection (b); and designed, finished, and applied to form a smooth, flush-interior surface. If gaskets are not used, all fittings shall have self-positioning faces designed to form a smooth, flush-interior surface. All interior surfaces of welded joints in pipelines shall be smooth and free from pits, cracks, or inclusions.

   (2)  In the case of welded lines, all welds shall be inspected by the use of a boroscope or other appropriate available inspection device as they are made, and such welds shall be approved by the Secretary.

   (3)  Each cleaning circuit shall have access points for inspection in addition to the entrances and exits. These may be valves, removable sections, fittings, or other means or combinations that are adequate for inspection of the interior of the line. These access points shall be located at sufficient intervals to determine the general condition of the interior surfaces of the line.

   (4)  Detailed plans for welded pipeline systems shall be submitted to the Secretary for written approval prior to installation. No alteration or addition shall be made to any welded milk pipeline system without prior written approval from the Secretary.

 (f)  Pasteurized milk and milk products shall be conducted from one piece of equipment to another only through sanitary milk piping.

 (a)  All multiuse containers and equipment with which milk or milk products come into contact shall be of smooth, impervious, corrosion-resistant and nontoxic material.

 (b)  All milk contact surfaces of multiuse containers and equipment shall consist of any of the following:

   (1)  Stainless steel of the AISI (American Iron and Steel Institute) 300 series.

   (2)  Equally corrosion-resistant metal which is nontoxic and nonabsorbent.

   (3)  Heat-resistant glass.

   (4)  Plastic or rubber and rubberlike materials which are relatively inert, and resistant to scratching, scoring, decomposition, crazing, chipping and distortion under normal use conditions; which are nontoxic, fat-resistant and relatively nonabsorbent; which do not impart flavor or odor to the product; and which maintain their original properties under repeated use conditions.

 (c)  All joints in containers, equipment, and utensils shall be flush and finished as smooth as adjoining surfaces. 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. 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.

 (d)  All openings in covers of tanks, vats, separators and the like shall be protected by raised edges or otherwise to prevent the entrance of surface drainage. Condensation-diverting aprons shall be provided as close to the tank or vat as possible on all pipes, thermometers, or temperature-sensing elements and other equipment extending into a tank, bowl, vat or distributor unless a watertight joint is provided.

 (e)  All surfaces with which milk or milk products come into contact shall be easily accessible or demountable for manual cleaning or shall be designed for mechanical cleaning. All product-contact surfaces shall be readily accessible for inspection and shall be self-draining. Wing nuts, bayonet locks and similar devices shall be used whenever possible in lieu of bolts and nuts to promote easy disassembly.

 (f)  There shall be no threads used in contact with milk or dairy products except where needed for functional and safety reasons such as in clarifiers, pumps and separators. Such threads shall be of a sanitary type.

 (g)  All multiuse containers and other equipment shall have rounded corners and shall be in good repair and free from breaks, crevices and corrosion. Milk cans shall have umbrella-type covers.

 (h)  Strainers, if used, shall be of perforated metal design and so constructed as to utilize single-service strainer media. Multiple-use woven material shall not be used for straining milk; provided that, when required for functional reasons inherent to the production of certain milk products such as buttermilk, whey and dry milk products, woven material may be used where it is impractical to use perforated metal. However, woven material parts shall be mechanically cleaned by such methods that thoroughly clean the woven material and do not contaminate the product.

 (i)  All single-service containers, closures, gaskets and other articles with which milk or milk products come in contact shall be nontoxic.

 (j)  The manufacture, packing, transportation and handling of single-service containers, closures, caps, gaskets and similar articles shall be approved by the Secretary. Inspections and tests will be made by the Secretary or any agency authorized by him. Milk handling equipment shall be constructed and installed to conform with 3A Standards.

 (a)  All multiuse containers and utensils shall be thoroughly cleaned and sanitized after each use, and all equipment shall be thoroughly cleaned and sanitized at least once each day used; provided that the storage tanks shall be cleaned when emptied and shall be emptied at least every 72 hours. Storage tanks which are used to store raw milk longer than 24 hours and silo tanks used for the storage of raw milk which are installed after August 7, 1982, shall be equipped with a 7-day circular chart temperature recording device or a strip chart which moves not less than 1 inch per hour. Such recording device shall meet all the requirements for storage tank recording thermometers in Appendix H of the PMO.

   (1)  All milk tank trucks shall be thoroughly cleaned and sanitized at least once each day of use.

   (2)  Whenever a milk tank truck has been cleaned and sanitized, there shall be attached to the manhole lid and under the dust cover, a tag showing the tank identity, date, time, place and signature of the employe or contract operator doing the work unless the truck delivers to only one receiving unit where responsibility for cleaning and sanitizing can be definitely established without tagging. The tag shall be removed at the location where the tank truck is next washed and sanitized and kept on file for at least 15 days for review by the Department.

 (b)  Pipelines and equipment designed for mechanical cleaning shall meet the following requirements:

   (1)  An effective cleaning and sanitizing regimen for each separate cleaning circuit shall be followed.

   (2)  A temperature-recording device shall be installed in the return solution line to record the temperature and time during which the line or equipment is exposed to cleaning and sanitizing.

   (3)  Temperature-recording charts shall be identified, dated and retained for three months.

 (c)  Plants in which containers are washed manually shall be equipped with a two-compartment wash-and-rinse vat for this purpose. Such plants shall also provide a steam cabinet or individual steam-jet plate with hood for sanitizing of cleaned containers or, if sanitizing is done with chemicals, a third treatment vat.

 (d)  In plants utilizing automatic bottle washers, such washers must provide for bactericidal treatment by means of steam, hot water or chemical treatment.

   (1)  In soaker-type bottle washers in which bactericidal treatment depends upon the causticity of the washing solution, the caustic strength for a given soaking time and temperature shall be as specified in the following table listing combinations of causticity, time and temperature of equal bactericidal value for soaker tank or soaker-type bottle washers.

   COMBINATIONS OF CAUSTICITY, TIME AND TEMPERATURES OF EQUAL BACTERICIDAL VALUE, FOR SOAKER TANK OR SOAKER-TYPE BOTTLE WASHERS
(Based on NSDA specifications for beverage bottles)

   (2)  When caustic is so used, subsequent final rinsing of the bottles shall be with water which has been treated with heat or chemicals to assure freedom from viable pathogenic or otherwise harmful organisms, to prevent contamination of the treated bottle during the rinsing operation.

 (e)  All multiuse containers, equipment, and utensils shall be sanitized before use, employing one or a combination of the methods prescribed under §  59.111 (relating to utensils and equipment—sanitization). Assembled equipment shall be sanitized prior to each day’s run. Plants using chemical sanitizing methods shall possess appropriate testing equipment.

 (f)  The residual bacteria count of multiuse and single-service containers used for packaging pasteurized milk and milk products shall not exceed 1/ml of capacity when the rinse test is used or 50 colonies per 8 square inches (one per square centimeter) of product-contact surface when the swab test is used in three out of four samples taken at random on a given day. All multiuse and single-service containers shall be free of coliform organisms.

 (g)  Plants which utilize multiuse plastic containers for pasteurized milk and milk products shall comply with the following criteria:

   (1)  The plastic material from which the containers are molded shall be of safe material.

   (2)  The plastic material shall comply with the material specifications of §  59.211 (relating to construction and repair of containers and equipment).

   (3)  All containers shall be identified as to plant of manufacture, date of manufacture, and type and class of plastic material used. This information may be by code provided that the code is revealed to the Department.

   (4)  A device shall be installed in the filling line capable of detecting in each container before it is filled volatile organic contaminants in amounts that are of public health significance. Such device must be constructed so that it may be sealed by the Secretary to prevent the changing of its sensitivity functioning level. Models using an air injection system and with a testing device built into the detection equipment do not have to be sealed. To assure proper functioning of the system the operator must be able to adjust the sensitivity; however, those models utilizing an external testing device must be sealed. Any container detected by the device as being unsatisfactory shall be automatically made unusable to prevent refilling. In addition, the device must be interconnected so that the system will not operate unless the detecting device is in proper operating condition; provided that any other system so designed and operated to provide equal assurance of freedom from contamination and recognized by the Department to be equally efficient may be accepted.

   (5)  A standard shall be available for the use by the Department for testing the proper sensitivity functioning levels of the detection device.

   (6)  The containers shall comply with the applicable construction requirements of §  59.211. The closure for the container shall be single-service. Screw-type closures shall not be used.

   (7)  The container shall not impart into the product pesticide residual levels or other chemical contaminants in excess of those considered acceptable under the Federal Food, Drug and Cosmetic Act and regulations issued thereunder.

   (8)  The phrase ‘‘Use Only for Food’’ shall appear on all containers.

 (a)  After cleaning, all multiuse containers, equipment, and utensils shall be transported or stored on metal racks or in clean cases elevated above the floor. Containers shall be stored inverted on racks or in cases constructed of relatively nonabsorbent, corrosion-resistant, nontoxic materials or otherwise protected from contamination.

 (b)  Floors shall not be flushed or washed when crates of clean bottles are stacked on them.

 (a)  Single-service caps, cap stock, parchment paper, containers, gaskets and other single-service articles for use in contact with milk and milk products shall be purchased and stored in sanitary tubes, wrappings, or cartons; shall be kept in a clean, dry place until used; and shall be handled in a sanitary manner.

 (b)  Paperboard shipping containers used to enclose plastic bags or unfilled containers shall be used only once unless other methods are employed to protect the containers from contamination.

 (c)  Tubes or cartons shall not be refilled with spilled caps, gaskets or parchment papers.

 (d)  Cartons or boxes from which contents have been partially removed shall be kept closed.

 (e)  Suitable cabinets shall be provided for storage of tubes after removal from the larger outer box and for storage of opened cartons, unless other satisfactory means are employed to protect the caps, closures or containers.

 (a)  Equipment and operations shall be so located within the plant as to prevent overcrowding and contamination of cleaned and sanitized containers, equipment, and utensils by splash, condensation or manual contact.

 (b)  During processing, pipelines and equipment used to contain or conduct milk and milk products shall be effectively separated from tanks or circuits containing cleaning or sanitizing solutions.

 (c)  All milk and milk products which have overflowed, leaked, been spilled, or been improperly handled shall be discarded. Milk and milk products drained from processing equipment at the end of a run or collected from a defoamer system which does not continuously return such product to the filler bowl—or milk solids rinsed from equipment, containers, or pipelines—shall be repasteurized only if such milk or milk products are handled in a sanitary manner and maintained at 45°F (7°C) or less. When the handling or refrigeration of such milk and milk products are not in compliance with this requirement, they shall be discarded. Returned packaged milk and milk products shall not be repasteurized for fluid milk; provided that the repasteurization of milk and milk products shipped in transport tankers which have been pasteurized at another plant and have been handled in a sanitary manner and maintained at 45°F (7°C) or less is permitted.

 (d)  All product-contact surfaces of containers, equipment, and utensils shall be covered or otherwise protected to prevent the access of insects, dust, condensation, and other contamination. All openings—including valves and piping attached to milk storage and milk tank trucks, pump, vats, and the like—shall be capped or otherwise properly protected. While unloading at a receiving station, transfer station, or pasteurization plant, one of the following conditions shall be met:

   (1)  If the area is completely enclosed—walls and ceiling, with doors closed—during the unloading process and the dustcover or dome and the manhole cover is opened slightly and held in this position by the metal clamps used to close the cover, then a filter is not required. However, if the dustcover or manhole cover are opened in excess of that provided by the metal clamps or if the covers have been removed, then a suitable filter shall be required for the manhole.

   (2)  If the area is not completely enclosed or if doors of the unloading area are open during unloading, then a suitable filter shall be required for the manhole or air inlet vent and suitable protection shall be provided over the filter material either by design of the filter holding apparatus or a roof or ceiling over the area. Direct connections from milk tank truck to milk tank truck shall be made from valve to valve and not from manhole to manhole, and the dustcover—dome—of the milk tank truck being filled shall be closed.

   (3)  Receiving and dump vats shall be completely covered, except during washing and sanitizing and when milk is being dumped. Where strainers are used, the cover for the vat opening shall be designed to cover the opening with a strainer in place.

 (e)  Whenever air under pressure is used for the agitation or movement of milk or is directed at a milk-contact surface, it shall be free of oil, dust, rust, excessive moisture, extraneous materials, and odor. Reference should be made to Appendix H of the PMO. The use of steam containing toxic substances is prohibited. Whenever steam is used in contact with milk or milk products, it shall be of culinary quality and shall comply with the applicable standards of quality.

 (f)  Standardization shall be done before the pasteurization process is started unless pasteurized milk or milk products are used for standardization. Such pasteurized products shall be protected against contamination. In no case shall pasteurized milk or milk products be standardized with unpasteurized milk unless the standardized product is subsequently pasteurized. Reconstituted or recombined milk and milk products shall be pasteurized after reconstitution or recombining of all ingredients. Standardization of milk and dairy products with other than approved milk and dairy products is prohibited.

 (g)  The processing of foods and drinks other than milk and milk products approved by the Secretary shall be performed to preclude the contamination of such milk and milk products. Such approved products shall be from a source acceptable to the Secretary with respect to sanitation and protection of public health.

 (h)  Means shall be provided to prevent contamination of milk containers, utensils, and equipment by drippings, spillage and splash from overhead piping, platforms, or mezzanines.

 (i)  All ingredients and nonproduct-contact materials used in the preparation or packaging of milk and milk products shall be stored in a clean place and shall be so handled as to prevent their contamination.

 (j)  Pasteurized milk shall not be strained or filtered except through a perforated metal strainer.

 (k)  Only those poisonous or toxic materials—including but not limited to insecticides, rodenticides, detergents, sanitizers, caustics, acids and related cleaning compounds—and medicinal agents necessary for the maintenance of the dairy plant shall be present in the dairy plant.

 (l)  Those poisonous or toxic materials that are necessary shall not be stored in any room where milk or milk products are received, processed, pasteurized, or stored where equipment, containers, or utensils are washed; or where single-service containers, closures or caps are stored.

 (m)  Those poisonous or toxic materials that are necessary shall be stored in a separate area of the plant in prominently and distinctly labeled containers; provided that this does not preclude the convenient availability of detergents or sanitizers to areas where equipment, containers and utensils are washed and sanitized.

 (n)  Only insecticides and rodenticides approved by the Department or registered with the United States Environmental Protection Agency shall be used for insect and rodent control. Such insecticides and rodenticides shall be used only in accordance with the manufacturer’s label directions and shall be prevented from contaminating milk, containers, equipment and utensils.

 Every particle of milk or milk product shall be heated in properly designed and operated equipment to one of the temperatures specified in the following table and held continuously at or above that temperature for at least the time specified:

   *If the fat content of the milk product is 10% or more, or if it contains added sweeteners, the specified temperature shall be increased by 5°F (3°C).

   (1)  Provided that eggnog and frozen dessert mix containing dairy products shall be heated to at least the following temperature and time specifications:

   (2)  Provided further, that nothing shall be construed as barring any other pasteurization process which has been recognized by the Food and Drug Administration to be equally efficient and which is approved by the Secretary.

 All indicating and recording thermometers used in connection with the batch pasteurization of milk or milk products shall comply with the applicable specifications set forth in Appendix H of the PMO.

   (1)  Time and temperature controls.

     (i)   Temperature difference.

       (A)   The pasteurizer shall be so designed that the simultaneous temperature difference between the milk or milk product at the center and the coldest milk or milk product in the vat will not exceed 1°F (0.5°C) at any time during the holding period.

       (B)   The vat shall be provided with adequate agitation, operating throughout the holding period. No batch of milk or milk product shall be pasteurized unless it covers a sufficient area of the agitator to insure adequate agitation.

     (ii)   Indicating and recording thermometers. Each batch pasteurizer shall be equipped with both an indicating and a recording thermometer. The thermometers shall read not less than the required pasteurization temperature throughout the required holding period. The plant operator shall check daily the temperature shown by the recording thermometer against the temperature shown by the indicating thermometer: this comparison shall be noted on the recording thermometer chart. The recording thermometer shall not read higher than the indicating thermometer. No batch of milk or milk products shall be pasteurized unless it is sufficient to cover the bulbs of both the indicating and the recording thermometers.

     (iii)   Assurance of minimum holding periods. Batch pasteurizers shall be so operated that every particle of milk or milk product will be held at not less than the minimum pasteurization temperature continuously for at least 30 minutes. When milk or milk products are raised to pasteurization temperature in the vat and cooling is begun in the vat simultaneously with or before the opening of the outlet valve, the recorder chart shall show at least 30 minutes at not less than minimum pasteurization temperature. When milk or milk products are preheated to pasteurization temperature before entering the vat, the recorder chart shall show a holding period of at least 30 minutes or not less than the minimum pasteurization temperature plus the time of filling from the level of the recorder bulb. When cooling is begun in the holder after the opening of the outlet valve or is done entirely outside the holder, the chart shall show at least 30 minutes at not less than the minimum pasteurization temperature plus the time of emptying to the level of the recording thermometer bulb.

       (A)   When the recorder time interval on the recorder chart at the pasteurization temperature includes filling or emptying time, such intervals shall be indicated on the recorder chart by the operator by removing the recording thermometer bulb from the milk for a sufficient time to depress the pen, by turning cold water into the vat jacket at the end of the holding period, or by inscribing the holding time on the chart. The filling time and the emptying time for each holder so operated will be determined by the Secretary, initially and after any change which may affect these times.

       (B)   No milk shall be added to the holder after the start of the holding period.

   (2)  Airspace heating.

     (i)   Means shall be provided and used in batch pasteurizers to keep the atmosphere above the milk and milk products at a temperature not less than 5°F (3°C) higher than the minimum required temperature of pasteurization during the holding period.

     (ii)   Each batch pasteurizer shall be equipped with an airspace thermometer. The surface of the milk or milk product shall be at least 1 inch below the bottom of the thermometer bulb when the vat is in operation.

     (iii)   The temperature shown by the airspace thermometer shall be recorded on the recording thermometer chart each time the pasteurizer is in operation.

   (3)  Inlet and outlet valve and connections. The following definitions shall apply to inlet and outlet valves and connections:

     (i)   ‘‘Valve stop’’ shall mean a guide which permits turning the valve plug to, but not beyond, the fully closed position.

     (ii)   ‘‘90° stop’’ shall mean a stop so designed as to prevent turning the plug more than 90°.

     (iii)   ‘‘120° stop’’ shall mean a stop which prevents turning the plug more than 120°.

     (iv)   ‘‘180° stop’’ shall mean a stop which prevents turning the plug more than 180° but which permits two fully closed positions, each diametrically opposite the other.

     (v)   ‘‘Valve with an irreversible plug’’ shall mean one in which the plug cannot be reversed in the shell.

     (vi)   ‘‘Single-quadrant stop’’ shall mean a 90° stop in a valve with an irreversible plug.

     (vii)   ‘‘The fully open position’’ shall mean that position of the valve seat which permits the maximum flow into or out of the pasteurizer.

     (viii)   ‘‘The closed position’’ shall mean any position of the valve seat which stops the flow of milk into or out of the pasteurizer.

     (ix)   ‘‘The fully closed position’’ shall mean that closed position of the valve seat which requires the maximum movement of the valve to reach the fully open position.

     (x)   ‘‘The just-closed position’’ shall mean that closed position of a plug-type valve in which the flow into or out of the holder is barely stopped or any closed position within 0.078 inch thereof as measured along the maximum circumference of the valve seat.

     (xi)   ‘‘Leakage’’ shall mean the entrance of unpasteurized milk into a batch pasteurizer during the holding or emptying period or the entrance of unpasteurized milk into any pasteurized milk line at any time.

     (xii)   ‘‘Leak-protector valve’’ shall mean a valve provided with a leak-diverting device which, when the valve is in any closed position, will prevent leakage of milk past the valve or, in the case of batch pasteurizers filled or emptied by suction or compressed air, will prevent leakage of milk past the valve or the leakage of milk due to the leakage of air past the suction valve or the compressed air valve, as the case may be.

     (xiii)   ‘‘Close-coupled valve’’ shall mean a valve the seat of which is either flush with the inner wall of the pasteurizer or so closely coupled that no milk in the valve inlet is more than 1°F (0.5°C) colder than the milk at the center of the pasteurizer at any time during the holding period. A close-coupled valve which is not truly flush shall be considered as satisfying this requirement when:

       (A)   the vat outlet is so flared that the smallest diameter of the large end of the flare is not less than the diameter of the outlet line plus the depth of the flare;

       (B)   the greatest distance from the valve seat to the small end of the flare is not greater than the diameter of the outlet line; and

       (C)   in the case of batch pasteurizers, the outlet and the agitator are so placed as to insure that milk currents will be swept into the outlet.

   (4)  Design and installation of valves and connections. All valves and connections shall comply with the following requirements:

     (i)   Valves and pipeline connections shall meet the requirements of §  59.210 (relating to sanitary piping).

     (ii)   All pipelines and fittings shall be so constructed and so located that leakage will not occur. Dependence shall not be placed on soldered joints to prevent leakage.

     (iii)   To prevent clogging and to promote drainage, all leak-protection grooves shall be at least 0.187 inches wide, and at least 0.094 inches deep at the center. Mating grooves shall provide these dimensions throughout their combined length whenever the valve is in or approximately in the fully-closed position. All single-leak grooves and all mating leak grooves when mated shall extend throughout the entire depth of the seat, so as to divert leakage occurring at all points throughout the depth of the seat and so as to prevent air bindings. Washers or other parts shall not obstruct leak-protector grooves.

     (iv)   A stop shall be provided on all plug-type outlet valves and on all plug-type inlet valves in order to guide the operator in closing the valve so that unpasteurized milk may not inadvertently be permitted to enter the outlet line or the holder, respectively. The stop shall be so designed that the plug will be irreversible when the plug is provided with any grooves or their equivalent; however, the plug need not be irreversible if duplicate, diametrically opposite grooves are also provided. In the case of two-way, plug-type valves—that is, those having only one inlet and one outlet—a 180° stop or any combination of stops permitting two fully closed positions may be substituted for a 90° stop provided that there are no air-relief grooves in the plug and that all leak grooves are located symmetrically with respect to the valve inlet. Stops shall be so designed that the operator cannot turn the valve beyond the stop position either by raising the plug or by any other means.

     (v)   Outlet valves shall be so designed as to prevent the accumulation of unpasteurized milk in the milk passages of the valve when the valve is in any closed position.

     (vi)   All inlet pipelines and outlets from vat pasteurizers shall be equipped with leak-protector valves; provided that installations not equipped with leak-protector inlet valves will be acceptable when the piping is so arranged that only one vat can be connected to the inlet line at a time and such piping is disconnected during the holding and emptying periods.

     (vii)   Inlet and outlet connections other than through closed-coupled valves shall not enter or leave the pasteurizer below the level of the milk therein.

     (viii)   In cases where the inlet enters the holder above the milk level and in which the inlet line may be submerged preventing its complete emptying when the inlet valve is closed, the inlet line shall be provided with an automatic air-relief or vent located either at the valve or elsewhere so designed as to function in every closed position of the valve. A vent may be provided by drilling a hole at least 0.125 inches in diameter in the vat pipe, below the vat cover but above the maximum milk level.

     (ix)   All leak-protector valves shall be installed in the proper position to insure the function of the leak-diverting device. Inlet valves shall not be located in vertical pipelines unless they can be so installed that one of the groove systems is at the lowest level of the valve, and pipelines between the inlet valve and the pasteurizer shall be as short as practicable and shall be sloped to drain.

     (x)   All outlet valves shall be kept fully closed during filling, heating, and holding periods; and all inlet valves shall be kept fully closed during holding and emptying periods.

   (5)  Recording charts. All recording thermometer charts shall comply with the applicable requirements of §  59.216d (relating to temperature-recording charts, equipment tests and examinations).

 (a)  Indicating thermometers and recorder/controller instruments. All indicating thermometers and recorder/controller instruments and devices used in connection with the high-temperature, short-time, continuous-flow pasteurization of milk or milk products shall comply with the applicable specifications set forth in Appendix H of the PMO.

 (b)  Automatic milk controller. Each high-temperature, short-time, continuous-flow pasteurization system shall be equipped with an automatic milk-flow control of the diversion type, which complies with paragraphs (1) and (2).

   (1)  ‘‘Automatic milkflow controls’’ shall mean those safety devices which control the flow of milk in relation to the temperature of the milk, heating medium, pressure, vacuum, or other auxiliary equipment. Milk-flow controls shall not be considered as part of the temperature control equipment. Milk-flow controls shall be of the flow-diversion type which automatically causes the diversion of the milk in response to a sublegal pasteurization temperature. At sublegal temperatures, flow-diversion devices return the milk to the raw milk side of the heating system continuously until legal pasteurization temperatures are obtained; at which time, the device restores forward flow through the pasteurizer.

   (2)  All flow-diversion devices used in continuous pasteurizers shall comply with the following or equally satisfactory specifications:

     (i)   Forward flow of subtemperature milk due to the omission or looseness of the connecting clip shall be prevented by:

       (A)   Making the valve and its actuating mechanism integral;

       (B)   Where there is a connecting device, by making it impossible to assemble the valve and its actuating mechanism except in such a manner that it will function properly;

       (C)   Where there is a connecting device which may be omitted or shaken loose, by providing for pushing, instead of pulling the valve to the diverted position;

       (D)   By providing that the pump will shut down when the milk is below the pasteurization temperature and the valve is not in the fully-diverted position; or

       (E)   By any other equally satisfactory means.

     (ii)   When a packing gland is used to prevent leakage around the actuating stem, it shall be impossible to tighten the stem packing nut to such an extent as to prevent the valve from assuming the fully-diverted position.

     (iii)   A leak escape shall be installed on the forward-flow side of the valve seat. However, when back pressure is exerted on the forward-flow side of the valve seat while the milkflow is being diverted, the leak escape should lie between two valve seats or between two portions of the same seat, one upstream and the other downstream from the leak escape. The leak escape shall be designed and installed to discharge all leakage to the outside or to the constant-level tank through a line separate from the diversion line; provided that when leakage is discharged to the constant-level tank, a sight glass shall be installed in the leak escape line in a vertical position to provide a visual means of leak detection.

     (iv)   The closure of the forward-flow seat shall be sufficiently tight so that leakage past it will not exceed the capacity of the leak escape device, as evidenced when the forward-flow line is disconnected; and, in order that proper seating may not be disturbed, the length of the connecting rod shall not be adjustable by the user.

     (v)   The flow-diversion device shall be so designed and installed that failure of the primary motivating power shall automatically divert the flow of milk.

     (vi)   The flow-diversion device shall be located downstream from the holder. The flow-control sensor shall be located in the milk line not more than 18 inches upstream from the flow-control device.

     (vii)   In the case of higher-heat, shorter-time (HHST) pasteurizing systems utilizing the temperature of 191°F (89°C) and above and holding times of one second and less, the flow-diversion device may be located downstream from the regenerator or cooler section; provided that when the flow-diversion device is located downstream from the regenerator or cooler section, the flow-diversion device shall be automatically prevented from assuming the forward-flow position until all product-contact surfaces between the holding tube and flow-diversion device have been held at or above the required pasteurization temperature continuously and simultaneously for at least the required pasteurization time as defined in §  59.1 (relating to definitions).

     (viii)   The pipeline from the diversion port of the flow-diversion device shall be self-draining and open to the atmosphere and shall be free of restrictions or valves, unless such restrictions or valves are so designed that stoppage of the diversion line cannot occur.

     (ix)   When it is used, the pipeline from the leak detection port of the flow-diversion device shall be self-draining, and shall be free of restrictions or valves, unless such restrictions or valves are so designed that stoppage of the leak detector line cannot occur.

 (c)  Milk-flow controller instrumentation. The following requirements shall be met with respect to the instrumentation of the milk-flow controller:

   (1)  The thermal limit controller shall be set and sealed so that forward flow of product cannot start unless the temperature at the controller sensor is above the required pasteurization temperature nor continue during descending temperatures when the temperature is below the required pasteurization temperature. The seal shall be applied by the regulatory agency after testing and shall not be removed without immediately notifying the regulatory agency. The system shall be so designed that no milk can be by-passed around the controller sensor, which shall not be removed from its proper position during the pasteurization process. The cut-in and cut-out milk temperatures, as shown by the indicating thermometer, shall be determined at the beginning of each day’s operation and entered upon the recorder chart daily by the plant operator.

   (2)  In the case of HHST pasteurization systems, utilizing the temperatures of 191°F (89°C) and above and holding times of one second or less, with the flow-diversion device located downstream from the regenerator or cooler section; additional temperature controllers and timers shall be interwired with the thermal limit controller, and the control system shall be set and sealed so that forward flow of product cannot start until all product-contact surfaces between the holding tube and flow-diversion device have been held at or above the required pasteurization temperature continuously and simultaneously for at least the required pasteurization time. The control system shall also be set and sealed so that forward flow cannot continue when the temperature of the product in the holding tube is below the required pasteurization temperature. The seal shall be applied by the regulatory agency after test and shall not be removed without immediately notifying the regulatory agency. The system shall be so designed that no product can be by-passed around the control sensors, which shall not be removed from their proper position during the pasteurization process. For these HHST systems, daily measurement by the operator of the cut-in and cut-out temperature is not required.

   (3)  Manual switches for the control of pumps, homogenizers, or other devices which produce flow through the holder shall be wired so that the circuit is completed only when the milk is above the required pasteurization temperature or when the diversion devise is in the fully-diverted position.

 (d)  Holding tube.

   (1)  Holders shall be designed to provide for the holding of every particle of milk or milk product for at least the time required for pasteurization.

   (2)  The holder shall be so designed that the simultaneous temperature difference between the hottest and coldest milk in any cross section of flow at any time during the holding period will not be greater than 1°F (0.5°C). This requirement may be assumed to have been satisfied without test in tubular holders of seven inches or smaller diameter which are free of any fittings through which the milk may not be thoroughly swept.

   (3)  No device shall be permitted for short circuiting a portion of the holder to compensate for changes in rate of milk flow. Holding tubes shall be installed so that sections of pipe cannot be left out, resulting in a shortened holding time.

   (4)  The holding tube shall be arranged to have a continuously upward slope in the direction of flow or not less than 0.25 inches a foot.

   (5)  Supports for tubes shall be provided to maintain all parts of holding tubes in a fixed position, free from any lateral or vertical movement.

   (6)  The holder shall be so designed that no portion between the inlet and the flow-control temperature sensor is heated.

   (7)  The holding time for the HHST processes shall be determined from the pumping rate rather than by the salt conductivity test because of the short holding tube. The holding tube length shall be such that the fastest flowing particle of any product will not traverse the holding tube in less than the required holding time. Since laminar flow can occur in the holding tube during pasteurization of high-viscosity products, holding tube lengths are calculated as twice the length required to hold the average flow for the standard time.

   (8)  With the steam injection process, a pressure limit indicator is needed in the holding tube to keep the heated product in the liquid phase. The instrument must have a pressure switch so that the flow-diversion device will move to the divert position if the product falls below a prescribed value. For operating temperatures between 191°F (89°C) and 212°F (100°C), the pressure switch shall be set at ten pounds per square inch (psi). For units which have operating temperatures above 212°F (100°C), the pressure switch shall be set at a pressure ten psi the boiling pressure of the product at its maximum temperature in the holding tube.

   (9)  With the steam injection process, a differential pressure limit indicator across the injector is needed to ensure adequate isolation of the injection chamber. The instrument must have a differential pressure switch so that the flow diversion device will move to the divert position if the pressure differential across the injector falls below ten psi.

 (e)  Indicating and recording thermometers.

   (1)  All indicating thermometers shall be located as near as possible to the temperature sensor of the recorder/controller but may be located a short distance upstream from the latter where milk between the two thermometers does not differ significantly in temperature.

   (2)  The temperature shown by the recorder/controller shall be checked daily by the plant operator against the temperature shown by the indicating thermometer. Readings shall be recorded on the chart. The recorder/controller shall be adjusted to read no higher than the indicating thermometer.

   (3)  The recorder/controller charts shall comply with the applicable provisions of §  59.216d (relating to temperature-recording charts equipment tests and examinations).

 (f)  Flow-promoting devices.

   (1)  The pump or pumps and other equipment which may produce flow through the holder shall be located up-stream from the holder, provided that pumps and other flow-promoting devices may be located downstream from the holder if means are provided to eliminate negative pressure between the holder and the inlet to such equipment. When vacuum equipment is located downstream from the holder, an effective vacuum breaker plus an automatic means of preventing negative pressure in the line between the flow-diversion device and the vacuum chamber will be acceptable.

   (2)  The speed of pumps or other flow-promoting devices governing the rate of flow through the holder shall be so controlled as to insure the holding of every particle of milk for at least the time required as defined in §  59.1 for the milk or milk products and the process used. In all cases, the motor shall be connected to the metering pump by means of common drive shaft or by means of gears, pulleys, or a variable-speed drive with the gear box, the pulley box, or the setting of the variable speed protected in such a manner that the holding time cannot be shortened without detection by the Department. This shall be accomplished by the application of a suitable seal after tests by the Department and such seal shall not be broken without immediately notifying the Department. This paragraph applies to all homogenizers used as timing pumps. Variable speed drives used in connection with the metering pump shall be so constructed that wearing or stretching of the belt results in a slowdown, rather than a speedup of the pump. The metering or timing pump shall be of the positive displacement type.

   (3)  The holding time shall be taken to mean th