Subchapter B. STANDARDS FOR MILK AND MILK PRODUCTS
GENERAL PROVISIONS
Sec.
59.51. Rule.
59.52. Table.
SANITATION REQUIREMENTS APPLICABLE TO PRODUCTION OF
MILK FOR PASTEURIZATION
MILK FOR PASTEURIZATION
59.101. Abnormal milk.
59.102. Milking barn, stable or parlor—construction and maintenance.
59.103. Milking barn, stable or parlor—cleanliness.
59.104. Cowyard.
59.105. Milkhouse or room—construction and facilities.
59.106. Milkhouse or room—cleanliness.
59.107. Toilet.
59.108. Water supply.
59.109. Utensils and equipment—construction.
59.110. Utensils and equipment—cleaning.
59.111. Utensils and equipment—sanitation.
59.112. Utensils and equipment—storage.
59.113. Utensils and equipment—handling.
59.114. Milking—flanks, udders and teats.
59.115. Milking—surcingles, milk stools and antikickers.
59.116. Protection from contamination.
59.117. Personnel—hand-washing facilities.
59.118. Personnel—cleanliness.
59.119. Cooling.
59.120. Vehicles.
59.121. Insect and rodent control.
SANITATION AND PROCEDURE REQUIREMENTS APPLICABLE
TO THE HANDLING AND PROCESSING OF PASTEURIZED MILK
AND MILK PRODUCTS (MILK PLANT)
TO THE HANDLING AND PROCESSING OF PASTEURIZED MILK
AND MILK PRODUCTS (MILK PLANT)
59.201. Floors—construction.
59.202. Walls and ceilings—construction.
59.203. Doors and windows.
59.204. Lighting and ventilation.
59.205. Separate rooms.
59.206. Toilet-sewage disposal facilities.
59.207. Water supply.
59.208. Hand-washing facilities.
59.209. Milk plant cleanliness.
59.210. Sanitary piping.
59.211. Construction and repair of containers and equipment.
59.212. Cleaning and sanitizing containers and equipment.
59.213. Storage of cleaned containers and equipment.
59.214. Storage of single-service containers, utensils and materials.
59.215. Protection from contamination.
59.216. Pasteurization.
59.216a. Batch pasteurization requirements.
59.216b. High temperature short-time (HTST) continuous flow pasteurization
requirements.
59.216c. Pasteurizers employing regenerative heating.
59.216d. Temperature-recording charts, equipment tests and examinations.
59.217. Cooling of milk.
59.218. Bottling and packaging.
59.219. Capping.
59.220. Personnel—cleanliness.
59.221. Vehicles.
59.222. Surroundings.
HANDLING
59.251. Receiving station requirements.
59.252. Transfer station requirements.
59.253. Tank truck cleaning and sanitation facilities requirements.
This subchapter cited in 7 Pa. Code § 39.5 (relating to standards for frozen dessert mix); 7 Pa. Code § 39.6 (relating to wholesale manufacturers of frozen desserts); 7 Pa. Code § 59.302 (relating to raw milk); 7 Pa. Code § 59.303 (relating to transferring; delivery containers; cooling; retail establishment handling practices); and 7 Pa. Code § 59.304 (relating to milk and milk products from beyond the limits of routine inspection).
GENERAL PROVISIONS
§ 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.
(b) No process or manipulation other than pasteurization, processing methods integral therewith, and appropriate refrigeration shall be applied to milk and milk products for the purpose of removing or deactivating microorganisms; provided, that, in the bulk shipment of raw cream, skim milk, or lowfat milk, the heating of the raw milk to temperatures no greater than 125°F (52°C) for separation purposes is permitted when the resulting bulk shipments of cream, skim milk and lowfat milk are labeled heat-treated.
The following table sets forth the chemical, bacteriological and temperature standards for milk and milk products: § 59.52. Table.
Milk for pasteurization Temperature— Bulk milk cooled to 40°F (4°C) or less within two hours after milking, provided that the blend temperature after the first and subsequent milkings does not exceed 50°F (10°C). Bacterial limits— Individual producer milk not to exceed 100,000 per ml. prior to commingling with other producer milk. Growth inhibitors— No growth inhibitor residue in excess of actionable level as determined by the B. stearothermophilus Disc Assay Method or equivalent. Somatic cell count— Samples exceeding 18 mm WMT to be confirmed by DMSCC or acceptable tests. Not to exceed 1 million per ml. Commingled milk Temperature— Maintained at 45°F or less. Bacterial limits— Not to exceed 300,000 per ml. Growth inhibitors— No growth inhibitor residue in excess of actionable levels as determined by the B. stearothermophilus Disc Assay Method or equivalent. Pasteurized milk Temperature— Cooled to 45°F (7°C) or less and maintained thereat. *Bacterial limits— 20,000 per ml. Coliform— Not to exceed 10 per ml., provided that, in the case of bulk milk transport tank shipments, shall not exceed 100 per ml. Phosphatase— Less than 1 microgram per ml. by the Scharer Rapid Method or equivalent. Growth inhibitors— No growth inhibitor residue in excess of actionable level as determined by the B. stearothermophilus Disc Assay Method or equivalent. Milk products Temperature— Cooled to 45°F (7°C) or less and maintained thereat. *Bacterial limits— 50,000 per gram. Coliform— Not to exceed 10 per gram. When fruit or nuts and flavoring is added after pasteurization, the count shall not exceed 20 per gram. Phosphatase— Less than 1 microgram per ml. by the Scharer Rapid Method or equivalent. *Tests to be on plain frozen dessert mix prior to addition of flavoring material. Growth inhibitors— No growth inhibitor residue in excess of actionable level as determined by the B. stearothermophilus Disc Assay Method or equivalent. *Milk ingredients used in frozen dessert mixes shall be tested for growth inhibitor. Raw milk Temperature— Cooled at 40°F (4°C) or less within two hours after milking, provided that the blend temperature after the first and subsequent milkings does not exceed 50°F (10°C). Bacterial limits— 20,000 per ml. Coliform— Not to exceed 10 per ml. Growth inhibitors— No growth inhibitor residue in excess of actionable level as determined by the B. stearothermophilus Disc Assay Method or equivalent. Somatic cell count— Samples exceeding 18 mm WMT to be confirmed by DMSCC or acceptable tests. Not to exceed 1,000,000 per ml. *Not applicable to cultured 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).
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).
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.§ 59.103. Milking barn, stable or parlor—cleanliness.
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).
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. § 59.106. Milkhouse or room—cleanliness.
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).
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.§ 59.107. Toilet.
This section cited in 7 Pa. Code § 59.31 (relating to inspection of dairy farms); 7 Pa. Code § 59.302 (relating to raw milk); and 7 Pa. Code § 59.707 (relating to protection and transport of raw milk and cream).
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.§ 59.110. Utensils and equipment—cleaning.
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).
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.§ 59.111. Utensils and equipment—sanitation.
This section cited in 7 Pa. Code § 59.31 (relating to inspection of dairy farms); 7 Pa. Code § 59.212 (relating to cleaning and sanitizing containers and equipment); and 7 Pa. Code § 59.302 (relating to raw milk).
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.§ 59.112. Utensils and equipment—storage.
This section cited in 7 Pa. Code § 59.31 (relating to inspection of dairy farms); 7 Pa. Code § 59.105 (relating to milkhouse or room—construction and facilities); and 7 Pa. Code § 59.302 (relating to raw milk).
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.§ 59.113. Utensils and equipment—handling.
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).
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.§ 59.114. Milking—flanks, udders and teats.
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).
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.§ 59.115. Milking—surcingles, milk stools and antikickers.
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).
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. § 59.117. Personnel—hand-washing facilities.
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).
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.§ 59.118. Personnel—cleanliness.
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).
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.§ 59.120. Vehicles.
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)
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.
This section cited in 7 Pa. Code § 59.251 (relating to receiving station requirements); 7 Pa. Code § 59.252 (relating to transfer station requirements); 7 Pa. Code § 59.253 (relating to tank truck cleaning and sanitizing facilities requirements); and 7 Pa. Code § 59.702 (relating to buildings).
(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.§ 59.202. Walls and ceilings—construction.
This section cited in 7 Pa. Code § 59.251 (relating to receiving station requirements); 7 Pa. Code § 59.252 (relating to transfer station requirements); 7 Pa. Code § 59.253 (relating to tank truck cleaning and sanitizing facilities requirements); and 7 Pa. Code § 59.702 (relating to buildings).
(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.§ 59.203. Doors and windows.
This section cited in 7 Pa. Code § 59.251 (relating to receiving station requirements); 7 Pa. Code § 59.252 (relating to transfer station requirements); 7 Pa. Code § 59.253 (relating to tank truck cleaning and sanitizing facilities requirements); and 7 Pa. Code § 59.702 (relating to buildings).
(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.§ 59.204. Lighting and ventilation.
This section cited in 7 Pa. Code § 59.251 (relating to receiving station requirements); 7 Pa. Code § 59.252 (relating to transfer station requirements); and 7 Pa. Code § 59.253 (relating to tank truck cleaning and sanitizing facilities requirements).
(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. § 59.205. Separate rooms.
This section cited in 7 Pa. Code § 59.251 (relating to receiving station requirements).
(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.§ 59.206. Toilet-sewage disposal facilities.
This section cited in 7 Pa. Code § 59.217 (relating to cooling of milk); 7 Pa. Code § 59.251 (relating to receiving station requirements); 7 Pa. Code § 59.252 (relating to transfer station requirements); 7 Pa. Code § 59.253 (relating to tank truck cleaning and sanitizing facilities requirements); and 7 Pa. Code § 59.703 (relating to facilities).
(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.§ 59.208. Hand-washing facilities.
This section cited in 7 Pa. Code § 59.251 (relating to receiving station requirements); 7 Pa. Code § 59.252 (relating to transfer station requirements); 7 Pa. Code § 59.253 (relating to tank truck cleaning and sanitizing facilities requirements); and 7 Pa. Code § 59.703 (relating to 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.§ 59.209. Milk plant cleanliness.
This section cited in 7 Pa. Code § 59.251 (relating to receiving station requirements); 7 Pa. Code § 59.252 (relating to transfer station requirements); 7 Pa. Code § 59.253 (relating to tank truck cleaning and sanitizing facilities requirements); 7 Pa. Code § 59.711 (relating to cleaning and sanitizing treatment); and 7 Pa. Code § 59.712 (relating to insect and rodent control program).
(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.§ 59.210. Sanitary piping.
This section cited in 7 Pa. Code § 59.109 (relating to utensils and equipment—construction); 7 Pa. Code § 59.216a (relating to batch pasteurization requirements); 7 Pa. Code § 59.218 (relating to bottling and packaging); 7 Pa. Code § 59.251 (relating to receiving station requirements); 7 Pa. Code § 59.252 (relating to transfer station requirements); 7 Pa. Code § 59.253 (relating to tank truck cleaning and sanitizing facilities requirements); and 7 Pa. Code § 59.704 (relating to equipment and utensils).
(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.§ 59.211. Construction and repair of containers and equipment.
This section cited in 7 Pa. Code § 59.251 (relating to receiving station requirements); 7 Pa. Code § 59.252 (relating to transfer station requirements); 7 Pa. Code § 59.253 (relating to tank truck cleaning and sanitizing facilities requirements); and 7 Pa. Code § 59.711 (relating to cleaning and sanitizing treatment).
(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.§ 59.213. Storage of cleaned containers and equipment.
This section cited in 7 Pa. Code § 59.251 (relating to receiving station requirements); 7 Pa. Code § 59.252 (relating to transfer station requirements); 7 Pa. Code § 59.253 (relating to tank truck cleaning and sanitizing facilities requirements); 7 Pa. Code § 59.703 (relating to facilities); and 7 Pa. Code § 59.704 (relating to 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.§ 59.216. Pasteurization.
Temperature Time *145°F (63°C) 30 minutes *161°F (72°C) 15 seconds 191°F (89°C) 1 second 194°F (90°C) 0.5 second 201°F (94°C) 0.1 second 204°F (96°C) 0.05 second 212°F (100°C) 0.01 second
Temperature Time 155°F (69°C) 30 minutes 175°F (80°C) 25 seconds 180°F (83°C) 15 seconds
This section cited in 7 Pa. Code § 59.216c (relating to pasteurizers employing regenerative heating).
(a) Milk-to-milk regenerative heating. Pasteurizers employing milk-to-milk regenerating heating with both sides closed to the atmosphere shall comply with the following or equally satisfactory specifications:
(1) Regenerators shall be constructed, installed, and operated so that pasteurized milk in the regenerator will automatically be under greater pressure than raw milk in the regenerator at all times.
(2) The pasteurized milk, between its outlet from the regenerator and the nearest point downstream open to the atmosphere, shall rise to a vertical elevation of 12 inches above the highest raw milk level downstream from the constant-level tank and shall be open to the atmosphere at this or a higher elevation. A vacuum breaker shall be considered open to the atmosphere.
(3) The overflow of the top rim of the constant-level raw milk tank shall always be lower than the lowest milk level in the regenerator.
(4) No pump or flow-promoting device which can affect the proper pressure relationships within the regenerator shall be located between the pasteurized milk outlet from the regenerator and the nearest downstream point open to the atmosphere.
(5) No pump shall be located between the raw milk inlet to the regenerator and the raw milk supply tank unless it is designed and installed to operate only when milk is flowing through the pasteurized milk side of the regenerator and when the pressure of the pasteurized milk is higher than the maximum pressure produced by the pump. This may be accomplished by wiring the booster pump so that it cannot operate unless:
(i) the metering pump is in operation;
(ii) the flow-diversion device is in forward-flow position; and
(iii) the pasteurized milk pressure exceeds by at least one psi the maximum pressure developed by the booster pump; pressure gauges shall be installed at the raw milk inlet to the regenerator and the pasteurized milk outlet of the regenerator or the outlet of the cooler. The accuracy of required pressure gauges will be checked by the Department.
(6) The motor, casing, and impeller of the booster pump shall be identified and such records thereof maintained as directed by the Department. All electric wiring interconnections should be in permanent conduit—except that rubber covered cable may be used for final connections—with no electrical connections to defeat the purpose of any provisions of this section, § § 59.216, 59.216a, 59.216b and 59.216d.
(7) All raw milk in the regenerator shall drain freely back into the constant-level raw milk tank when the raw milk pumps are shut down and the raw milk outlet from the regenerator is disconnected.
(8) When vacuum equipment is located downstream from the flow-diversion device, means shall be provided to prevent the lowering of the pasteurized milk level in the regenerator during periods of diverted flow or shut-down. An effective vacuum breaker, and an automatic means of preventing a negative pressure shall be installed in the line between the vacuum chamber and the pasteurized milk to the regenerator.
(9) 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 and/or cooler section, the requirement that the pasteurized product from the outlet of the regenerator or cooler shall rise to vertical elevation of 12 inches above the highest raw product level downstream from the constant-level tank and shall be open to the atmosphere at this or a higher elevation may be eliminated; provided that a differential pressure controller is used to monitor the highest pressure in the raw product side of the regenerator and the lowest pressure in the pasteurized side of the regenerator; and provided that the controller is interlocked with the flow-diversion device and is set and sealed so that whenever improper pressures occur in the regenerator, forward flow of product is automatically prevented and will not start again 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.
(10) When culinary steam is introduced directly into milk or milk products as the means of terminal heating to achieve pasteurization temperature and vacuum equipment is located downstream from the holding tube, the requirement that a vacuum breaker be installed at the inlet to the pasteurized side of the regenerator may be eliminated; provided that the differential pressure controller is installed and wired to control the flow-diversion device as described in paragraph (9).
(11) When the differential pressure controller is installed and wired to control the flow-diversion device as described in paragraph (9), the raw product booster pump may be permitted to run at all times, provided the metering pump is in operation.
(b) Milk-to-water-to-milk regenerative heating. Milk-to-water-to-milk regenerators with both the milk and the heat-transfer water in the raw milk section closed to the atmosphere shall comply with the following or equally satisfactory specifications:
(1) Regenerators of this type shall be so designed, installed, and operated that the heat-transfer-medium side of the regenerator in the raw milk section will automatically be under greater pressure than the raw side at all times.
(2) The heat-transfer water shall be safe and the heat-transfer water shall be in a covered tank which is open to the atmosphere at an elevation higher, by at least 12 inches, than any raw milk level downstream from the constant-level tank. The heat-transfer water between its outlet from the regenerator and the nearest point downstream open to the atmosphere shall rise to a vertical elevation of at least 12 inches above any raw milk in the system and shall be open to the atmosphere at this or a higher elevation.
(3) The heat-transfer water circuit shall be full of water at the beginning of the run, and all loss of water from the circuit shall automatically and immediately replenish whenever raw milk is present in the regenerator.
(4) The overflow of the top rim of the constant level raw milk tank shall always be lower than the lowest milk level in the raw milk section of the regenerator. The regenerator shall be designed and installed so that all raw milk shall drain freely back to the upstream supply tank when the raw milk pumps are shut down and the raw milk line is disconnected from the regenerator outlet.
(5) No pump shall be located between the raw milk inlet to the regenerator and the raw milk supply tank unless it is designed and installed to operate only when water is flowing through the heat-transfer section of the regenerator and when the pressure of the heat-transfer water is higher than the pressure of the raw milk. This may be accomplished by wiring the booster pump so that it cannot operate unless:
(i) The heat-transfer water pump is in operation.
This section cited in 7 Pa. Code § 59.216a (relating to batch pasteurization requirements); 7 Pa. Code § 59.216b (relating to high temperature short-time (HTST) continuous flow pasteurization requirements); and 7 Pa. Code § 59.216c (relating to pasteurizers employing regenerative heating).
(a) All raw milk and milk products be maintained at 45°F (7°C) or less until processed.
(b) All pasteurized milk and milk products except those to be cultured shall be cooled immediately in approved equipment prior to filling and packaging to a temperature of 45°F (7°C) or less. All pasteurized milk and milk products shall be stored at a temperature of 45°F (7°C) or less.
(c) Each refrigerator room in which milk or milk products are stored shall be equipped with an indicating thermometer. Such thermometer shall be located in the warmest zone of the refrigerator room. Each storage tank shall be equipped with an indicating thermometer, the sensor of which shall be located to permit the registering of the temperature of the contents when the tank contains no more than 20% of its calibrated capacity. Such thermometers shall comply with the applicable specifications of Appendix H of the PMO.
(d) All surface coolers comply with the following specifications:
(1) The sections of open-surface coolers shall be so installed as to leave a gap of at least 0.25 inches between the header sections to permit easy cleaning.
(2) Where header ends are not completely enclosed within the cooler covers, condensation or leakage from the headers shall be prevented from entering the milk or milk products by so shaping the exposed header faces, above and below all gaps, that condensation is directed away from the tubes and by using deflectors at the bottom of the headers, by shortening the bottom trough, or by some other approved method.
(3) The location of supports of cooler sections shall prevent drip from entering the milk or milk products.
(4) All open-surface coolers shall be provided with tight-fitting shields which protect the milk and milk products from contamination by flies, dust, drip, splash, or manual contact.
(e) Recirculated cold water which is used in coolers and exchangers, including those systems in which a freezing point depressant is used, shall be from a safe source and shall be protected from contamination. Such water shall be tested semiannually and shall comply with the bacteriological standards as cited in § 59.207 (relating to water supply). Recirculated water systems which become contaminated through repair work or otherwise shall be properly treated and tested before being returned to use. Freezing point depressants, when used in recirculating systems, shall be nontoxic. This section cited in 7 Pa. Code § 59.251 (relating to receiving station requirements); and 7 Pa. Code § 59.704 (relating to equipment and utensils).
(a) All milk and milk products, including concentrated milk and milk products, shall be bottled and packaged at the plant where final pasteurization is performed. Such bottling and packaging shall be done without undue delay following final pasteurization.
(b) All bottling or packaging shall be done on mechanical equipment. The term ‘‘mechanical equipment’’ shall not be meant to exclude manually operated machinery but is meant to exclude methods in which the bottling and capping devices are not integral in one system. Such equipment is subject to the approval of the Department.
(c) Bottling or packaging machines shall be designed to minimize the need for adjustment during operation. All pipes, connections, defoaming devices, and similar appurtenances shall comply with § 59.210 (relating to sanitary piping) and § 59.211 (relating to construction and repair of containers and equipment).
(d) Bottling or packaging machines supply tanks and bowls shall have covers which are constructed to prevent any contamination from reaching the inside of the filler tank or bowl. All covers shall be in place during operation.
(e) A drip reflector shall be installed on each filler valve. Such drip deflector shall be designed and adjusted to divert condensation away from the open container.
(f) Container in-feed conveyors to automatic bottling or packaging machines shall have overhead shields to protect the bottles or packages from contamination. Such shields shall extend from the bottle washer discharge to the bottle feed star or, in the case of single-service packaging machines, from the forming unit discharge to the filling unit and from the filling unit to the closure unit. Overhead shields shall be required on can infeed conveyors when the cans are fed to the filler with covers off.
(g) Container fabricating materials such as paper stock, foil, wax, and plastic, shall be handled in a sanitary manner and protected against undue exposure during the package assembly operation.
(h) Bottling and packaging machine floats shall be designed to be adjustable without removing the cover.
(i) The filler pipe of all bottling and packaging machines shall have an apron or other approved device as close to the filler bowl as possible to prevent condensation or drip from reaching the inside of the filler bowl.
(j) Filling cylinders on packaging machines shall be protected from contamination by the use of overhead shields. When any lubricant is applied to the filler pistons, cylinders, or other milk-contact surfaces, the lubricant shall be nontoxic and sterile and shall be sparingly applied in a sanitary manner.
(a) The capping or closing of milk and milk product containers shall be done in a sanitary manner on mechanical capping/closing equipment. The term ‘‘mechanical capping/closing equipment’’ shall not exclude manually operated machinery. Such equipment shall be subject to the approval of the Department. Hand-capping shall be prohibited; provided that, if suitable mechanical equipment for the capping or closing of specific containers of three gallons or more is not available, other methods which eliminate all possibility of contamination may be approved by the Department.
(b) All mechanical capping or closing mechanisms shall be designed to minimize the need for adjustment during operation.
(c) Bottles and packages which have been imperfectly capped or closed shall be emptied immediately into approved sanitary containers. Such milk or milk products shall be protected from contamination, maintained at 45°F (7°C) or less, and subsequently repasteurized or discarded.
(d) All caps and closures shall be designed and applied in such a manner that the pouring lip is protected to at least its largest diameter and that, with respect to fluid product containers, removal cannot be made without detection if sold off premises where processed. Single-service containers shall be so constructed that the product and the pouring and opening areas are protected from contamination during handling and storage and when the containers are initially opened.
(e) Caps and closures shall be handled in a sanitary manner. The first cap from each tube, the first lap from each roll of cap or cover stock, and the first sheet of parchment or cover paper shall be discarded. The subsequent use of loose caps which are left in the capper at the end of an operating period after removal from the cap tubes shall be a violation of this subsection.
(a) Hands shall be thoroughly washed before commencing plant functions and as often as may be required to remove soil and contamination.
(b) Each employe shall wash his hands following a visit to the toilet room and prior to resuming work.
(c) All persons while engaged in the processing, pasteurization, handling, storage, or transportation of milk, milk products, containers, equipment, and utensils shall wear clean outer garments.
(d) Persons while engaged in the processing of milk or milk products shall not use tobacco and shall wear adequate head covering. This section cited in 7 Pa. Code § 59.251 (relating to receiving station requirements); and 7 Pa. Code § 59.705 (relating to personnel cleanliness).
All vehicles used for transportation of pasteurized milk and milk products shall be constructed and operated so that the milk and milk products are maintained at 45°F (7°C) or less and are protected from sun, from freezing, and from contamination.
(1) All vehicles shall be kept clean.
(2) Material which is capable of contaminating milk or milk products shall not be transported with milk or milk products.
(3) Vehicles shall have fully enclosed bodies with well-fitted solid doors. This section cited in 7 Pa. Code § 59.251 (relating to receiving station requirements); 7 Pa. Code § 59.252 (relating to transfer station requirements); 7 Pa. Code § 59.253 (relating to tank truck cleaning and sanitizing facilities requirements); 7 Pa. Code § 59.701 (relating to surroundings); and 7 Pa. Code § 59.712 (relating to insect and rodent control program).
All receiving stations shall comply with § § 59.201—59.215, 59.217 and 59.220—59.222.
A transfer station shall comply with § § 59.201—59.204, 59.206—59.212, 59.214, 59.215 and 59.222.
Facilities for cleaning and sanitizing milk tank trucks shall comply with § § 59.201—59.204, 59.206—59.212, 59.214, 59.215 and 59.222. This section cited in 7 Pa. Code § 59.707 (relating to protection and transport of raw milk and cream); and 7 Pa. Code § 59.711 (relating to cleaning and sanitizing treatment).
§ 59.216c. Pasteurizers employing regenerative heating.
§ 59.217. Cooling of milk.
§ 59.218. Bottling and packaging.
§ 59.219. Capping.
§ 59.220. Personnel—cleanliness.
§ 59.221. Vehicles.
§ 59.251. Receiving station requirements.
§ 59.252. Transfer station requirements.
§ 59.253. Tank truck cleaning and sanitation facilities requirements.
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