§ 59.1. Definitions.

 The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:

   Abnormal milk—Milk secreted from cows immediately after parturition, curdled, ropy, bloody or mastitic condition or cows treated with, or cows which have consumed chemical, medicinal or radioactive agents which are capable of being secreted in the milk and which, in the judgment of the Department may be deleterious to human health.

   Acceptable milk—Milk that qualified under §  59.502 (relating to sight and odor) as to sight and odor, and that is classified No. 1 or No. 2 for sediment content—§  59.503 (relating to sediment content classification)—and No. 1 or No. 2 for bacterial estimate—§  59.504 (relating to bacterial estimate classification).

   Approved dairy ingredients—Milk and dairy products approved by the Department.

   Approved milkgrader—A person approved by the Department for the grading of raw milk for manufacturing in accordance with the quality standards and procedures of this subchapter using sight, odor and sediment grading.

   Approved sampler—A person certified by the Department to obtain samples of milk or milk products for analysis by a Pennsylvania approved laboratory.

   Aseptically processed dairy products—Milk and milk products which are packaged in hermetically sealed containers allowing storage for long periods of time without refrigeration.

   Aseptically processed and packaged milk or milk product—Milk or milk product thermally processed, either before or after sealing in a hermetically sealed container, so as to render the product free of microorganisms capable of reproducing in the product under normal nonrefrigerated conditions of storage and distribution, and shall be free of viable microorganisms (including spores) of public health significance. The product shall conform with applicable provisions of the 1978 Grade A Pasteurized Milk Ordinance.

   Bulk milk pick-up tanker—A vehicle—including the truck, tank, and those appurtenances necessary for its use—used by a milk hauler to transport bulk raw milk for pasteurization or for manufacturing purposes from a dairy farm to a transfer station, receiving station, or milk plant.

   Bulk tank unit (BTU)—A specified group of dairy farms from which milk for pasteurization or for manufacturing purposes is collected by a milk tank truck.

   Certified milk—Milk from dairy farms operated in accordance with ‘‘Methods and Standards for the Production and Distribution of Certified Milk,’’ last adopted by the American Association of Medical Milk Commissioners, Inc., the production and handling of which shall be certified by a commission instituted in compliance herewith.

   Classification of farm sanitation compliance—

   (i) Passing—A general compliance with sanitary standards established for the production of milk.

   (ii) Reinspect—A significant noncompliance with sanitary standards established for the production of milk requiring remedial action and a subsequent review to determine conformity.

   (iii) Suspend—Major noncompliance with sanitary standards or evidence of conditions that would render the milk unsafe for human consumption, or if on the reinspection it is found that sufficient progress has not been made on the previously recommended corrections.

   Cleaned-In-Place (CIP)—The procedure by which sanitary pipelines or pieces of dairy equipment are mechanically cleaned in place by circulation.

   Commingled milk—Milk from two or more producers; in a milk plant, a representative sample of all daily sources of milk prior to pasteurization.

   Cowyard—The enclosed or unenclosed area adjacent to the milking barn in which cows may congregate.

   Dairy farm—Any place where cows or goats are kept and from which a part or all of the milk is sold.

   Department—The Pennsylvania Department of Agriculture.

   Designated inspector—A Pennsylvania Approved Inspector who has been certified to inspect dairy farms on which milk is produced for an interstate milk shipper.

   Dry milk and whey products—Products which have been produced for use in pasteurized milk or milk products and which have been manufactured under this chapter.

   Excluded milk for manufacturing—All of a producer’s milk excluded from the market by §  59.507 (relating to inspection and testing of milk).

   Food establishment—A retail food store and a room, building or place or portion thereof or vehicle maintained, used or operated for the purpose of commercially storing, packaging, making, cooking, mixing, processing, bottling, baking, canning, freezing, packing or otherwise preparing or transporting or handling food. The term includes those portions of public eating and drinking licensees which offer food for sale for off-premises consumption, except those portions of establishments operating exclusively under milk or milk products permits.

   Growth inhibitor—Any antimicrobial adulterant, including but not limited to antibiotics.

   Hermetically sealed container—A container that is designed and intended to secure against entry of microorganisms and thereby maintain the commercial sterility of its contents after processing.

   Higher heat shorter time pasteurization—A process through which every particle of a dairy product is heated to between 191°F and 212°F at holding times between 1.0 and 0.1 seconds before packaging, so as to produce a product which has an extended shelf life under refrigerated conditions.

   Homogenized—Milk or a milk product has been treated to insure breakup of the fat globules to such an extent that, after 48 hours of quiescent storage at 45 F(7°C), no visible cream separation occurs on the milk and that the fat percentage of the top 100 milliliters of milk in a quart, or of proportionate volumes in containers of other sizes, does not differ by more than 10% from the fat percentage of the remaining milk as determined after thorough mixing.

   Lactose-reduced milk or lactose-reduced lowfat milk or lactose-reduced skim milk—The product resulting from the treatment of milk, lowfat milk or skim milk by the addition of safe and suitable enzymes to convert sufficient amounts of lactose to glucose or galactose, or both, so that the remaining lactose is less than 30% of the lactose in milk, lowfat milk or skim milk.

   Manufactured dairy products—Butter, cheese (natural or processed), dry whole milk, nonfat dry milk, dry buttermilk, dry whey and dry whey products, evaporated milk (whole or skim), condensed whole and condensed skim milk (plain or sweetened), and other products for human consumption designated by the Secretary.

   Milk—The natural lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows or goats.

   Milk distributor—Any person who offers for sale or sells any milk or milk product.

   Milk for manufacturing purposes—Milk produced for processing and manufacturing into products for human consumption, not subject to requirements of milk for pasteurization, except for applicable provisions in this chapter.

   Milk for pasteurization—Milk which conforms with relevant provisions of this chapter and is used in the preparation of pasteurized milk and milk products.

   Milk plant—Any place where milk or milk products are collected, handled, processed, stored, pasteurized, packaged, or prepared for distribution.

   Milk processor—Any person who operates a plant where milk is received or processed.

   Milk producer—Any person who operates a dairy farm.

   Milk products—Ice cream, ice cream mix, custard ice cream, French ice cream, frozen custard, ice milk, sherbet, and other similar frozen and semifrozen products and all dairy products used in the manufacture thereof.

   Milk tank truck—A bulk milk pick-up tanker or a milk transport tank.

   Milk transport tank—A vehicle including the truck and tank used by a milk hauler to transport bulk shipments of milk from a transfer station, receiving station, or milk plant to another transfer station, receiving station, or milk plant.

   Milking parlor—The area of a dairy barn which is used exclusively for the milking of cows and in which no bedding is used.

   New producer—A producer who has not produced milk or cream for pasteurization or for manufacturing purposes.

   Official laboratory—A biological, chemical, or physical laboratory which is under the direct supervision of the Department.

   Pasteurized concentrated dairy products—Includes homogenized concentrated milk, concentrated skim milk, concentrated lowfat milk, and similar concentrated products made from concentrated milk or concentrated skim milk, which, when combined with potable water in accordance with instructions printed on the container, conform with the definitions of the corresponding dairy products in this section.

   Pasteurized frozen milk concentrate—A frozen dairy product with a composition of milkfat and milk solids not fat in proportions so that, when a given volume of concentrate is mixed with a given volume of water, the reconstituted product conforms to the milkfat and milk solids not fat requirements of whole milk. In the manufacturing process, water may be used to adjust the primary concentrate to the final desired concentration. The adjusted primary concentrate is pasteurized, packaged, and immediately frozen. This product is stored, transported and sold in the frozen state.

   Pasteurized low-sodium milk or low-sodium lowfat milk or low-sodium skim milk—The product resulting from the treatment of milk, lowfat milk or skim milk by a process of passing the milk, lowfat milk or skim milk through an ion exchange resin process or by any process which has been recognized by the Food and Drug Administration that effectively reduces the sodium content of the product to less than 10 milligrams in 100 milliliters.

   Pasteurized product—Every particle of such product shall have been heated in properly operated equipment approved by the Secretary, to one of the temperatures specified in the following table and held continuously at or above that temperature for the specified time (or other time/temperature relationship equivalent thereto in microbial destruction):

    *If the fat content of the dairy product is 10% or more, or if it contains added sweeteners, the specified temperature shall be increased by 5°F(3°C); provided that eggnog and frozen dessert mix containing dairy products shall be heated to at least the following temperature and time specifications:

   Nothing in this definition 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.

   Pennsylvania approved dairy laboratory—

     (i) A commercial or regulatory laboratory authorized by the Department to do official analyses of milk and milk products.

     (ii) A milk industry laboratory officially designated by the Department for the examination of producer samples of raw milk for pasteurization or of commingled raw milk for pasteurization for the detection of growth inhibitor residues and bacterial limits. Such laboratories may also be designated for the examination of milk products—frozen desserts and frozen desserts mixes—processed under their direct control.

   Pennsylvania approved inspector—A person who has demonstrated, by examination and field evaluation, his proficiency in inspecting dairy farms and has been issued a license by the Secretary to enforce this part.

   PMO—The 1978 Grade A Pasteurized Milk Ordinance, which is a document published periodically by the United States Department of Health and Human Services covering the recommendations of the United States Public Health Service/Food and Drug Administration giving procedures governing the Cooperative State—Public Health Service/Food and Drug Administration Program for certification of interstate milk shippers.

   Permit holder—A person holding a permit issued by the Department to sell milk or milk products.

   Probational milk—Milk classified No. 3 for sediment content—§  59.503 or milk classified undergrade for bacterial estimate—§  59.504 that may be accepted by plants for specific time periods.

   Raw milk—Raw milk is milk which conforms with the relevant provisions of this chapter and may be sold to consumers without further treatment or processing.

   Receiving station—Any place where raw milk is received, collected, handled, stored, or cooled and prepared for further transporting.

   Reject milk—Milk that does not qualify under §  59.502 or that is classified No. 4 for sediment content—§  59.503, which is rejected by the plant under §  59.505 (relating to rejected milk).

   Retail food store—An establishment or section of an establishment where food and food products are offered to the consumer and intended for off-premises consumption.

   Sanitization—The application of any effective method or substance to a clean surface for the destruction of pathogens and of other organisms as far as is practicable.

   Secretary—The Secretary of Agriculture of the Commonwealth or his authorized representative.

   3A Sanitary Standards—Standards promulgated jointly by the Sanitary Standards Subcommittee of the Dairy Industry Committee; the Committee on Sanitary Procedure of the International Association of Milk, Food and Environmental Sanitarians, Inc.; and the Milk and Food Branch, Division of Environmental Engineering and Food Protection, Public Health Service, Department of Health and Human Services.

   Standard Methods—Standard Methods for the Examination of Dairy Products, published by the American Public Health Association.

   Transfer producer—A producer who has sold milk or cream, or both, to a milk plant and who changes his sales to another milk plant.

   Transfer station—Any place where milk or milk products are transferred directly from one milk tank truck to another.

   Ultra-pasteurized product—A product thermally processed at or above 280°F (138°C) for at least 2 seconds, either before or after packaging, so as to produce a product which has an extended shelf life under refrigerated conditions.

   Weigher/sampler—A bulk milk pick-up driver or a milk plant person certified by the Department to take samples of producers’ milk for chemical and bacteriological analyses.

   The provisions of this §  59.1 issued under the act of July 2, 1935 (P. L. 558, No. 163) (31 P. S. § §  645—660f).

   The provisions of this §  59.1 amended October 11, 1985, effective October 12, 1985, 15 Pa.B. 3642; amended July 5, 1996, effective July 6, 1996, 26 Pa.B. 3129; amended December 13, 1996, effective December 14, 1996, 26 Pa.B. 5950; amended September 5, 2003, effective September 6, 2003, 33 Pa.B. 4445. Immediately preceding text appears at serial pages (223210) to (223216).

 This chapter will be applied in conjunction with Chapter 57 (relating to milk and dairy products—general provisions) concerning identity of milk and milk products.

SPECIFIC PROVISIONS

§ 59.11. Contents.

 Milk that is in final package form for beverage use shall contain not less than 8.25% milk solids not fat and not less than 3.25% milkfat.

 (a)  Milk or milk products produced and distributed for sale shall not be adulterated in any manner by the addition of substances not normally found therein, except those substances approved by the Secretary in this chapter.

 (b)  The Secretary may seize, condemn, denature, or destroy any milk or milk product without compensation to the owner or owners thereof if he considers the milk or milk product unsafe or a menace to public health.

 (a)  Permits will be required for the sale of milk and milk products and will be issued only upon application.

 (b)  Separate permit shall be obtained for each milk plant, milk distributor, receiving station, transfer station, and bulk tank unit and by every producer of raw milk.

 (c)  The permit year shall begin September 1 of each year and end on August 31 of the following year.

   This section cited in 7 Pa. Code §  59.716 (relating to permits).

LABELING

§ 59.21. General labeling requirements.

 (a)  The term, ‘‘milk,’’ unqualified, means cow’s milk. Milk derived from goats shall be labeled as such.

 (b)  All bottles, containers and packages enclosing milk and milk products shall be labeled in accordance with § §  57.41 and 57.42 (relating to labeling) and, where specific labeling requirements are not prescribed in this section or §  59.22 (relating to milk dating), Federal labeling requirements shall be followed.

 (c)  All bottles, containers, and packages enclosing milk or milk products offered for sale, except milk tank trucks, storage tanks, and cans of raw milk from dairy farms shall be marked with the following information:

   (1)  Name of the food, raw, pasteurized, certified, or other such designations as approved by the Department.

   (2)  Name and address of the processor or distributor, as appropriate.

   (3)  Identity of plant where processed.

   (4)  The word ‘‘reconstituted’’ or ‘‘recombined’’ if the product is made by reconstitution or recombination.

   (5)  The volume or proportion of water to be added for reconstitution or recombination, in the case of concentrated milk or milk products.

 (d)  Proposed labeling of all containers and closures shall be submitted to the Department for approval.

 (e)  All vehicles containing milk or dairy products shall be legibly marked with the name and address of the milk plant or hauler in possession of the contents. Milk transport tank trucks transporting bulk milk and dairy products shall be sealed and shall be accompanied by a legible shipping statement containing the following information:

   (1)  Shipper’s name, address, and plant identification number.

   (2)  Identification of hauler.

   (3)  Point of origin of shipment.

   (4)  Tanker identification number.

   (5)  Name of product.

   (6)  Weight of product.

   (7)  Grade of product.

   (8)  Temperature of product.

   (9)  Date of shipment.

   (10)  Name of supervisory regulatory agency at point of origin.

   (11)  Whether the product is raw, pasteurized or heat-treated.

 (f)  All cans of raw milk from individual dairy farms shall be identified by name or number of the producer.

 (g)  Misleading marks, words or endorsements upon the label are prohibited. Registered trade designs or terms may be permitted on the container cap or label provided they are not misleading and do not obscure the required labeling.

 (a)  Label requirement. The cap or nonglass container of pasteurized milk held in retail food stores, restaurants, schools or similar food establishments for resale shall be conspicuously and legibly marked in a contrasting color with the designation of the ‘‘sell-by’’ date—the month and day of the month after which the product may not be sold or offered for sale. The designation may be numerical—such as ‘‘8-15’’—or with the use of an abbreviation for the month, such as ‘‘AUG 15 or AU 15.’’ The words ‘‘Sell by’’ or ‘‘Not to be sold after’’ shall precede the designation of the date, or the statement ‘‘Not to be sold after the date stamped above’’ shall appear legibly on the container. This designation of the date may not exceed 17 days beginning after midnight on the day on which the milk was pasteurized.

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

 (c)  Prohibition. Pasteurized milk may not be sold or offered for sale if either of the following occurs:

   (1)  The milk is sold or offered for sale after the sell-by date designated on the container.

   (2)  Without regard to the sell-by date designated on the container, the milk exceeds the bacterial limits for pasteurized milk described in §  59.52 (relating to table).

 (d)  Exemption. The following pasteurized dairy products are exempt from the requirements of this section:

   (1)  Ultra-pasteurized dairy products.

   (2)  Cultured dairy products.

   (3)  Aseptically processed dairy products.

   (4)  Dairy products that have undergone higher heat shorter time pasteurization.

   (5)  Milk sold or offered for retail sale on the same premises at which it was processed.

 (e)  Monitoring by the Department.

   (1)  The Department will periodically sample containers of pasteurized milk in the possession of the processor or distributor. This sampling may occur at any time before the pasteurized milk is delivered to the store or the customer. The Department will sample at least one milk product from each processor each calendar year.

   (2)  The samples described in paragraph (1) shall be analyzed by a Pennsylvania-approved dairy laboratory, applying a methodology set forth in the most current edition of Dairy Practices Council Guideline No. 10, entitled ‘‘Guidelines for Maintaining and Testing Fluid Milk Shelf Life,’’ to determine whether the bacterial test results exceed the bacterial limits for pasteurized milk described in §  59.52 prior to the expiration of the sell-by date designated on the retail container.

   (3)  When two or more samples demonstrate a processor cannot produce pasteurized milk that remains consistently within the bacterial limits referenced in paragraph (2) during a 17-day sell-by period, the Department will require a processor to use a sell-by date of something less than the 17-day period described in subsection (a). The Department will calculate this revised sell-by date so that bacterial growth in the milk will not exceed the referenced bacterial limits within that sell-by period if the milk is maintained in accordance with the temperature standards for pasteurized milk in §  59.52.

   (4)  A processor may submit samples to the Department for analysis to obtain approval to resume a 17-day sell-by period for the product sampled. The Department will approve resumption of a 17-day sell-by period when analysis of a sample demonstrates that bacterial growth in the milk will not exceed the referenced bacterial limits within that sell-by period if the milk is maintained in accordance with the temperature standards for pasteurized milk in §  59.52.

   The provisions of this §  59.22 amended under the act of July 2, 1935 (P. L. 589, No. 210) (31 P. S. § §  645—660g).

   The provisions of this §  59.22 amended September 4, 1987, effective September 5, 1988, 17 Pa.B. 3599; amended August 9, 1991, effective August 10, 1991, 21 Pa.B. 3508; amended July 5, 1996, effective July 6, 1996, 26 Pa.B. 3129; amended September 5, 2003, effective September 6, 2003, 33 Pa.B. 4445. Immediately preceding text appears at serial pages (217606) to (217607).

   This section cited in 7 Pa. Code §  46.385 (relating to potentially hazardous food: hot and cold holding); 7 Pa. Code §  59.21 (relating to general labeling requirements); and 7 Pa. Code §  59.32 (relating to sampling and examination).

QUALITY CONTROL

§ 59.31. Inspection of dairy farms.

 (a)  Each producer of milk for pasteurization will be inspected initially and on any change of market by a Pennsylvania approved inspector and shall have a passing score before the first milk is shipped. All producers shall be inspected no less than once in each 6-month period by a Pennsylvania approved inspector, and an accurate record of farm inspections shall be maintained on forms acceptable to the Secretary.

 (b)  Producers who cannot produce milk of a wholesome, sanitary quality are to be excluded. Producers who are not in substantial compliance with § §  59.101—59.121 (relating to sanitation requirements applicable to production of milk for pasteurization) will be reinspected after an appropriate time for correction of deficiencies.

 (c)  Inspectors of farms producing milk for interstate shipment will be designated as an agent of the Secretary and certified in accordance with provisions of the PMO.

 (a)  The sampling and testing required in this section shall be the responsibility of the permit holder.

 (b)  Raw milk and raw cream shall be tested at least semimonthly for the standard plate count and coliform group and monthly for somatic cell count and growth inhibitor.

 (c)  It shall be the responsibility of the weigher/sampler to collect a representative sample of milk from each farm bulk tank prior to transferring milk from a farm bulk tank, truck or other container. All samples shall be collected and delivered to a milk plant, receiving station, transfer station, laboratory or other location approved by the Department.

 (d)  At least monthly, one sample of milk for pasteurization shall be obtained from each producer by an approved sampler. At least monthly, one sample of commingled milk shall be taken by an approved sampler from each milk plant after receipt of the milk by the plant and prior to pasteurization. In addition, at least monthly, one sample of pasteurized milk and each milk product shall be taken from each milk plant. Frozen desserts—vanilla, chocolate, and one other flavor where applicable—shall be tested at least monthly for the standard plate count and coliform group. Milk products mix shall be tested at least monthly for the standard plate count, coliform group, and phosphatase activity. Samples of milk and milk products shall be taken while in possession of the processor or distributor at any time prior to delivery to the store or customer. Samples of milk and milk products from dairy retail stores, food service establishments, grocery stores, and other places where milk and milk products are sold shall be examined periodically as determined by the Department; and the results of such examination will be used to determine compliance with §  59.11 (relating to contents), §  59.16 (relating to adulterated milk or milk products), and § §  59.21 and 59.22 (relating to labeling). Proprietors of such establishments shall furnish the Department, upon request, with the names of all distributors from whom milk or milk products are obtained.

 (e)  Required bacterial counts, somatic cell counts, and cooling temperature checks shall be performed on milk for pasteurization. In addition, growth-inhibitor tests on each producer’s milk or on commingled raw milk from tank trucks shall be conducted at least monthly. When commingled milk is tested, all producers shall be represented in the sample. All individual sources of milk shall be tested when test results on the commingled milk are positive. Required bacterial counts, growth-inhibitor tests, coliform determinations, phosphatase tests, and cooling temperature checks shall be performed on pasteurized milk and dairy products.

 (a)  Whenever two of the last four consecutive bacterial counts, somatic cell counts, coliform determinations, or cooling temperatures—taken on separate days—exceed the limit of the standard for the milk or dairy products, the Department will send a written notice thereof to the permit holder concerned. In the case of individual producers, the permit holder shall send the written notice. This notice shall be in effect so long as two of the last four consecutive samples exceed the limit of the standard. In the case of an individual milk producer, whenever test standards are exceeded by three of the last five bacteria, temperature, or somatic cell counts, the plant purchasing the milk shall immediately exclude such milk from the supply for a period of at least two days or until such time as conformance can reasonably be assured. In the case of a permit holder, whenever the standard of the product is exceeded by three of the last five bacteria counts, coliform determinations or temperature determinations, the permit holder shall be subject to the punitive clause of the Milk Sanitation Law, section 20 of the act of July 2, 1935 (P. L. 589, No. 210) (31 P. S. §  660d).

 (b)  Whenever a phosphatase test is positive, the cause shall be determined. When the cause is improper pasteurization, it shall be corrected, and any milk or milk product involved shall not be offered for sale. Reference should be made to §  59.309 (relating to approved laboratory reports).

 (c)  Whenever a growth-inhibitor or pesticide residue test is positive, an investigation shall be made to determine the cause, and the cause shall be corrected. An additional sample shall be taken and tested for growth-inhibitor or pesticide residues, and no milk shall be offered for sale until it is shown by a subsequent sample to be free of growth-inhibitor or pesticide residue or below the actionable levels established for such residues.

 (d)  When a test conducted by an approved laboratory indicates that milk from a producer is unsafe due to a growth inhibitor, the permit holder shall immediately notify and suspend the producer for 2 days. A test shall be made of the subsequent milking after suspension, and it must be free of growth inhibitor before offering that milk for sale.

 (a)  Samples analyzed for added water and found to have a freezing point above -0.525°H(-0.508°C) shall be considered adulterated unless proven free of added water.

 (b)  Samples shall be analyzed at an official or a Pennsylvania approved dairy laboratory. All sampling procedures and required laboratory examinations with the current edition of the Standard Methods for the Examination of Dairy Products of the American Public Health Association and the current edition of the Official Methods of Analysis of the Association of Official Analytical Chemists or other methods approved by the Secretary. Such procedures, including the certification of sample collectors and examination, shall be evaluated in accordance with the Evaluation of Milk Laboratories, 1978 Recommendations of the United States Public Health Service/Food and Drug Administration. Examinations and tests to detect adulterants, including pesticides, shall be conducted as the Department requires.

 (c)  Assays of milk and dairy products to which vitamins or minerals have been added shall be made at least annually in a laboratory acceptable to the Department, and a copy of the results shall be sent to the Department. If, in the opinion of the Department, there is reason to doubt that fortification is being carried out properly, the Department may require additional samples to be tested at the expense of the permit holder.

   This section cited in 7 Pa. Code §  59.302 (relating to raw milk); and 7 Pa. Code §  59.304 (relating to milk and milk products from beyond the limits of routine inspection).

Subchapter B. STANDARDS FOR MILK AND MILK PRODUCTS

GENERAL PROVISIONS

Sec.

§ 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)