[41 Pa.B. 2540]
[Saturday, May 21, 2011]
[Continued from previous Web Page]
SUPPLEMENTAL REQUIREMENTS FOR
PLANTS MANUFACTURING, PROCESSING
AND PACKAGING BUTTER AND
RELATED PRODUCTS§ 59a.361. Rooms and compartments.
(a) Coolers and freezers. The coolers and freezers must be equipped with facilities for maintaining proper temperature and humidity conditions, to protect the quality and condition of the products during storage or during tempering prior to further processing. Coolers and freezers shall be kept clean, orderly, free from insects, rodents and mold, and maintained in good repair. They must be adequately lighted and proper circulation of air shall be maintained at all times. The floors, walls and ceilings must be of a construction that permits thorough cleaning.
(b) Churn rooms. Churn rooms, in addition to proper construction and sanitation, must be equipped so the air is kept free from objectionable odors and vapors and extreme temperatures by means of adequate ventilation and exhaust systems or air conditioning and heating facilities.
(c) Print and bulk packaging rooms. Rooms used for packaging print or bulk butter and related products must, in addition to proper construction and sanitation, provide an atmosphere relatively free from mold (no more than 10 mold colonies per cubic foot of air), dust or other airborne contamination and be maintained at a reasonable room temperature.
§ 59a.362. Equipment and utensils.
(a) General construction, repair and installation. Equipment and utensils necessary to the manufacture of butter and related products must meet requirements in § 59a.304 (relating to equipment and utensils).
(b) Continuous churn. Product contact surfaces must be of noncorrosive material. Nonmetallic product contact surfaces must comply with the current 3-A Standards for Multiple-Use Plastic Materials or the current 3-A Sanitary Standards for Multiple-Use Rubber, and Rubber-Like Materials. Product contact surfaces must be readily accessible for cleaning and inspection.
(c) Conventional churn. Churns must be constructed of aluminum, stainless steel or equally corrosion resistant metal, free from cracks and in good repair. Gasket material must be fat resistant, nontoxic and reasonably durable. Seals around the doors must be tight.
(d) Bulk butter trucks, boats and packers. Bulk butter trucks, boats and packers must be constructed of aluminum, stainless steel or equally corrosion resistant metal free from cracks, seams and have a surface that is relatively smooth and easily cleanable.
(e) Butter, frozen or plastic cream melting machines. Shavers, shredders or melting machines used for rapid melting of butter, frozen or plastic cream must be of stainless steel or equally corrosion resistant metal, sanitary construction and easily cleanable.
(f) Printing equipment. Printing equipment must comply with the current 3-A Sanitary Standards for Equipment for Packaging Viscous Products.
(g) Brine tanks. Brine tanks used for the treating of parchment liners must be constructed of noncorrosive material and have an adequate and safe means of heating the salt solution for the treatment of the liners. The tank must also be provided with a satisfactory drainage outlet.
(h) Starter vats. Bulk starter vats must be of stainless steel or equally corrosion resistant metal and constructed according to applicable 3-A Sanitary Standards. The vats must be in good repair, equipped with tight-fitting lids and have effective temperature controls.
§ 59a.363. Operations and operating procedures.
(a) Pasteurization. The milk or cream shall be pasteurized at the plant where the milk or cream is processed into the finished product.
(1) Cream for buttermaking. Requirements are as follows:
(i) The cream for buttermaking shall be pasteurized at a temperature of at least 165° F and held continuously in a vat at that temperature at least than 30 minutes, pasteurized by the HTST method at a minimum time and temperature of at least 185° F for at least 15 seconds or by another equivalent time and temperature combination that is approved by the Department. Additional heat treatment above the minimum pasteurization requirement is advisable to insure improved keeping quality characteristics.
(ii) Adequate pasteurization control shall be used and the diversion valve shall be set to divert at less than 185° F with a 15 second holding time or its equivalent in time and temperature to assure pasteurization. If the vat or holding method of pasteurization is used, vat covers shall be closed prior to the holding period to assure temperature of air space reaching the minimum temperature before holding time starts. Covers shall also be kept closed during the holding and cooling period.
(2) Cream for plastic or frozen cream. The pasteurization of cream for plastic or frozen cream shall be accomplished in the same manner as in paragraph (1)(i) except that the temperature for the vat method shall be at least 170° F for at least 30 minutes, at least 190° F for at least 15 seconds or by another temperature and holding time which will assure adequate pasteurization and comparable keeping quality characteristics.
(b) Composition and wholesomeness. Ingredients used in the manufacture of butter and related products shall be subject to inspection and must be wholesome and practically free from impurities. Chlorinating facilities shall be provided for butter wash water if needed and other necessary precautions shall be taken to prevent contamination of products. Finished products must comply with the Food, Drug, and Cosmetic Act (21 U.S.C.A. §§ 301—399a), as to composition and wholesomeness.
(c) Containers. Containers must comply with the following:
(1) Containers used for the packaging of butter and related products must satisfactorily protect the quality of the contents in regular channels of trade. Caps or covers which extend over the lip of the container shall be used on all cups or tubs containing 2 pounds or less to protect the product from contamination during subsequent handling.
(2) Liners and wrappers must comply with the following:
(i) Supplies of parchment liners, wrappers and other packaging material must be protected against dust, mold and other possible contamination.
(ii) Prior to use, parchment liners for bulk butter packages shall be completely immersed in a boiling salt solution in a suitable container constructed of stainless steel or other equally noncorrosive material. The liners shall be maintained in the solution for at least 30 minutes. The solution must consist of at least 15 pounds of salt for every 85 pounds of water and shall be strengthened or changed as frequently as necessary to keep the solution full strength and in good condition.
(iii) Other liners, such as polyethylene, shall be treated or handled to prevent contamination of the liner prior to filling.
(3) The lined butter containers shall be protected from possible contamination prior to filling.
(d) Printing and packaging. Printing and packaging of consumer size containers of butter shall be conducted under sanitary conditions.
(e) General identification. Commercial bulk shipping containers must be legibly marked with the name of the product, net weight, name and address of manufacturer, processor or distributor or other assigned plant identification—manufacturer's lot number, churn number, and the like—and other identification that may be required. Packages of plastic or frozen cream must be marked with the percent of milkfat.
(f) Storage of finished product in coolers. Products must be kept under refrigeration at temperatures of 40° F or lower after packaging and until ready for distribution or shipment. The products may not be placed directly on floors or exposed to foreign odors or conditions such as drippage due to condensation which might cause package or product damage.
(g) Storage of finished product in freezer.
(1) Sharp freezers. Plastic cream or frozen cream intended for storage shall be placed in quick freezer rooms immediately after packaging for rapid and complete freezing within 24 hours. The packages must be piled or spaced so that air can freely circulate between and around the packages. The rooms shall be maintained at -10° F or lower and shall be equipped to provide sufficient high-velocity air circulation for rapid freezing. After the products have been completely frozen, they may be transferred to a freezer storage room for continued storage.
(2) Freezer storage. Freezer storage must comply with the following:
(i) The room shall be maintained at a temperature of 0° F or lower. Air circulation must be sufficient to preclude odors and maintain uniform storage temperatures throughout the freezer.
(ii) Butter intended to be held more than 30 days shall be placed in a freezer room as soon as possible after packaging. If not frozen before being placed in the freezer, the packages shall be spaced to permit rapid freezing and repiled, if necessary, at a later time.
SUPPLEMENTAL REQUIREMENTS FOR
PLANTS MANUFACTURING AND
PACKAGING CHEESE§ 59a.371. Rooms and compartments.
(a) Starter room. Starter rooms or areas shall be properly equipped and maintained for the propagation and handling of starter cultures. Necessary precautions shall be taken to prevent contamination of the starter, the room, equipment and the air therein.
(b) Make room. The room in which the cheese is manufactured must be of adequate size, and the vats adequately spaced to permit movement around the vats and presses for proper cleaning and satisfactory working conditions. Adequate ventilation shall be provided.
(c) Drying room. If cheese is to be paraffined, a drying room of adequate size shall be provided to accommodate the maximum production of cheese during the flush period. Adequate shelving and air circulation shall be provided for proper drying. Suitable temperature and humidity control facilities shall be provided.
(d) Paraffining room or area. For rind cheese, a separate room or area shall be provided for paraffining and boxing the cheese. The room or area must be of adequate size and the temperature maintained near the temperature of the drying room to avoid sweating of the cheese prior to paraffining.
(e) Rindless block wrapping area. For rindless blocks, a suitable space shall be provided for proper wrapping and boxing of the cheese. The area must be free from dust, condensation, mold or other conditions which may contaminate the surface of the cheese or contribute to the unsatisfactory packaging of the cheese.
(f) Coolers or curing rooms. Coolers or curing rooms where cheese is held for curing or storage must be clean and maintained at the proper uniform temperature and humidity to adequately protect the cheese. Proper circulation of air shall be maintained at all times. The rooms must be free from rodents, insects and pests. The shelves shall be kept clean and dry.
(g) Cutting and packaging rooms. When small packages of cheese are cut and wrapped, separate rooms shall be provided for the cleaning and preparation of the bulk cheese and a separate room shall be provided for the cutting and wrapping operation. The rooms must be well lighted, ventilated and provided with filtered air. Air movement must be outward to minimize the entrance of unfiltered air into the cutting and packaging room.
§ 59a.372. Equipment and utensils.
(a) General construction, repair and installation. Equipment and utensils necessary to the manufacture of cheese and related products must meet the requirements of § 59a.304 (relating to equipment and utensils). In addition, for other equipment the following requirements in this section shall be met.
(b) Starter vats. Bulk starter vats must be of stainless steel or equally corrosion resistant metal and must be in good repair, equipped with tight-fitting lids and have adequate temperature controls, such as valves, indicating or recording thermometers. New vats shall be constructed according to the applicable 3-A Sanitary Standards.
(c) Cheese vats. Requirements are as follows:
(1) Open vats used for making cheese must be of metal construction with adequate jacket capacity for uniform heating. The inner liner must be minimum 16-gauge stainless steel, properly pitched from side to center and from rear to front for adequate drainage. The liner must be smooth, free from excessive dents or creases and extend over the edge of the outer jacket. The outer jacket must be constructed of stainless steel or other equally corrosion resistant metal which can be kept clean and sanitary. The junction of the liner and outer jackets must be constructed to prevent milk or cheese from entering the inner jacket.
(2) The vat must be equipped with a suitable sanitary outlet valve. Effective valves must be provided and properly maintained to control the application of heat to the vat.
(3) Enclosed cheese vats must meet the requirements of the current 3-A Sanitary Standards for Enclosed Cheese Vats and Tables.
(d) Mechanical agitators. The mechanical agitators must be of sanitary construction. The carriage and track must be constructed to prevent the dropping of dirt or grease into the vat. Metal blades, forks or stirrers must be constructed of stainless steel, and be free from rough or sharp edges which might scratch the equipment or remove metal particles.
(e) Curd mill and miscellaneous equipment. Knives, hand rakes, shovels, paddles, strainers and miscellaneous equipment must be stainless steel or of material approved in the 3-A Sanitary Standards. The product contact surfaces of the curd mill must be of stainless steel. Pieces of equipment must be constructed so they can be kept clean. The wires in the curd knives must be stainless steel or other suitable metal, kept tight and replaced when necessary.
(f) Hoops and followers. The hoops, forms and followers must be constructed of stainless steel or heavy tinned steel. If tinned, they shall be kept tinned and free from rust. Hoops, forms and followers shall be kept in good repair. Drums or other special forms used to press and store cheese must be clean and sanitary.
(g) Press. The cheese press must be constructed of stainless steel with all joints welded and all surfaces, seams and openings readily cleanable. The pressure device must be the continuous type. Press cloths shall be maintained in good repair and in a sanitary condition. Single-service press cloths shall be used only once.
(h) Rindless cheese press. The press used to heat seal the wrapper applied to rindless cheese must have square interior corners, reasonably smooth interior surface and have controls that provide uniform pressure and heat equally to all surfaces.
(i) Paraffin tanks. The metal tank must be adequate in size, have parafinned wood or metal racks to support the cheese, heat controls and an indicating thermometer. The cheese wax shall be kept clean.
(j) Automatic curd conveyors. When the salted curd is moved to a hooping station for blocks or barrels by means of an air conveying system, the nonproduct contact surfaces of the system must be constructed of suitable nontoxic material which is corrosion resistant. Product contact surfaces must be constructed of stainless steel with all joints welded or properly gasketed, and all surfaces readily accessible and cleanable. The air shall be filtered and of sufficient quality for the intended use. Air compressors or vacuum pumps may not be located in the processing or packaging areas.
(k) Whey probes. Vacuum equipment used to withdraw whey from cheese must be constructed of stainless steel tubes and be readily accessible and removable for cleaning and inspection.
(l) Cheese vacuumizer. Bulk cheese vacuum chambers, if used, must be installed so that floor surfaces underneath are effectively sealed or have enough clearance so they can be cleaned. Interior surfaces of the vacuum chamber must be constructed and maintained so that the product is not contaminated with rust or flaking paint. An inner liner of stainless steel or other corrosion resistant material shall be provided.
§ 59a.373. Operations and operating procedures.
(a) Cheese from pasteurized milk.
(1) When the cheese is labeled as pasteurized, the milk shall be pasteurized by subjecting every particle of milk to a minimum temperature of 161° F for at least 15 seconds.
(2) HTST pasteurization units must be equipped with the proper controls and equipment to assure pasteurization. If the milk is held more than 2 hours between time of receipt or heat treatment and setting, it shall be cooled to 45° F or lower until time of setting.
(b) Cheese from unpasteurized milk. When the cheese is labeled as ''heat treated,'' ''unpasteurized,'' ''raw milk'' or ''for manufacturing,'' the milk may be raw or heated at temperature below pasteurization. If the milk is held more than 2 hours between time of receipt or heat treatment and setting, it shall be cooled to 45° F or lower until time of setting.
(c) Whey disposal. Disposal of whey shall be as follows:
(1) Adequate sanitary facilities shall be provided for the disposal of whey. If outside, necessary precautions shall be taken to minimize flies, insects and development of objectionable odors.
(2) Whey or whey products intended for human food shall at all times be handled in a sanitary manner under this subpart as specified for handling milk and dairy products. Equipment operated on a batch or vat basis shall be cleaned or thoroughly rinsed between batches or vats. If equipment is operated on a continuous basis, the whey collection pans shall be rinsed at least once every 2 hours of operation with potable water.
(d) Packaging and repackaging. Packaging rindless cheese or cutting and repackaging all styles of bulk cheese requires a high level of sanitation to prevent the contamination of exposed product. The atmosphere of the packaging rooms, the equipment and the packaging material must be practically free from mold and bacterial contamination.
(e) General identification. Each bulk cheese must be legibly marked with the name of the product, code or date of manufacture, vat number, officially designated code number or name and address of manufacturer. Each consumer sized container must be plainly marked with the name and address of the manufacturer, packer, or distributor, net weight of the contents, name of the product and other information that may be required.
SUPPLEMENTAL REQUIREMENTS FOR
PLANTS MANUFACTURING, PROCESSING
AND PACKAGING PASTEURIZED PROCESS CHEESE AND RELATED PRODUCTS§ 59a.381. Equipment and utensils.
(a) General construction, repair and installation. The equipment and utensils used for the handling and processing of cheese products must be as specified in § 59a.304 (relating to equipment and utensils). In addition, for certain other equipment the requirements in this section shall be met.
(b) Conveyors. Conveyors must be constructed of material which can be properly cleaned, will not rust, or otherwise contaminate the cheese, and shall be maintained in good repair.
(c) Grinders or shredders. The grinders or shredders used in the preparation of the trimmed and cleaned natural cheese for the cookers must be adequate in size. Product contact surfaces must be of corrosion resistant material, and of a construction to prevent contamination of the cheese and to allow thorough cleaning of all parts and product contact surfaces.
(d) Cookers. The cookers must be the steam jacketed or direct steam type. The cookers must be constructed of stainless steel or other equally corrosion resistant material. Product contact surfaces must be readily accessible for cleaning. Each cooker must be equipped with an indicating thermometer and a temperature recording device. Steam check valves on direct steam type cookers must be mounted flush with cooker wall, constructed of stainless steel and designed to prevent the backup of product into the steam line, or the steam line must be constructed of stainless steel pipes and fittings which can be readily cleaned. If direct steam is applied to the product, only culinary steam shall be used.
(e) Fillers. The hoppers of all fillers must be covered but the cover may have sight ports. If necessary, the hopper may have an agitator to prevent buildup on side wall. The filler valves and head shall be kept in good repair, capable of accurate measurements.
§ 59a.382. Operations and operating procedures.
(a) Trimming and cleaning. The natural cheese shall be cleaned free of all nonedible portions. Paraffin and bandages as well as rind surfaces, mold or unclean areas of another part which is unwholesome or unappetizing shall be removed.
(b) Cooking the batch. Each batch of cheese within the cooker, including the optional ingredients, shall be thoroughly commingled, the contents pasteurized at a temperature of at least 158° F and held at that temperature for at least 30 seconds. Care shall be taken to prevent the entrance of cheese particles or ingredients after the cooker batch of cheese has reached the final heating temperature. After holding for the required period of time, the hot cheese shall be emptied from the cooker as quickly as possible.
(c) Forming containers. Containers either lined or unlined shall be assembled and stored in a sanitary manner to prevent contamination. Procedures must be in place for the handling of containers between forming and filling that prevent contamination of the product contact surfaces. Preforming and assembling of pouch liners and containers shall be kept to a minimum and the supply rotated to limit the length of time exposed to possible contamination prior to filling.
(d) Filling containers. Hot fluid cheese from the cookers may be held in hotwells or hoppers to assure a constant and even supply of processed cheese to the filler or slice former. Filler valves must effectively measure the desired amount of product into the pouch or container in a sanitary manner and cut off sharply without drip or drag of cheese across the opening. An effective system shall be used to maintain accurate and precise weight control. Damaged or unsatisfactory packages shall be removed from production, and the cheese may be salvaged into sanitary containers and added back to cookers.
(e) Closing and sealing containers. Pouches, liners or containers having product contact surfaces after filling shall be folded or closed and sealed in a sanitary manner, preferably by mechanical means, to assure against contamination. Each container in addition to other required labeling must be coded in a manner that is easily identifiable as to date of manufacture by lot or sublot number.
SUPPLEMENTAL REQUIREMENTS FOR
PLANTS MANUFACTURING, PROCESSING AND PACKAGING EVAPORATED, CONDENSED OR STERILIZED MILK PRODUCTS§ 59a.391. Equipment and utensils.
(a) General construction, repair and installation. The equipment and utensils used for processing and packaging evaporated and condensed milk shall be as specified in § 59a.304 (relating to equipment and utensils).
(b) Evaporators and vacuum pans. Equipment used in the removal of moisture from milk or milk products for the purpose of concentrating the solids must meet the requirements of the current 3-A Sanitary Standards for Milk and Milk Products Evaporators and Vacuum Pans. New or used replacements for this type of equipment must meet the appropriate 3-A Sanitary Standards.
(c) Fillers. Both gravity and vacuum type fillers must be of sanitary design and all product contact surfaces, if metal, must be made of stainless steel or equally corrosion resistant material. Certain evaporated milk fillers having brass parts may be approved if free from corroded surfaces and kept in good repair. Fillers must be designed so that they in no way will contaminate or detract from the quality of the product being packaged.
(d) Batch or continuous in-container sterilizers. Batch or continuous in-container sterilizers must be equipped with accurate temperature controls and effective valves for regulating the sterilization process. The equipment shall be maintained to assure control of the length of time of processing and to minimize the number of damaged containers.
(e) Homogenizers. Homogenizers, where applicable, shall be used to reduce the size of the fat particles and to evenly disperse them in the product. New homogenizers must meet the applicable 3-A Sanitary Standards.
§ 59a.392. Operations and operating procedures.
(a) Preheat, pasteurization. When pasteurization is intended or required by either the vat method, HTST method, or by the UHT method it shall be accomplished by systems and equipment meeting the requirements of § 59a.304 (relating to equipment and utensils).
(b) Sterilization. The complete destruction of all living organisms shall be performed in one of the following methods:
(1) The complete in-container method, by heating the container and contents to a range of 212° F to 280° F for a sufficient time.
(2) By a continuous flow UHTST process at high temperature of 280° F and above for a sufficient time, then packaged aseptically.
(3) The product is first sterilized according to UHTST methods as in paragraph (2), then packaged and given further heat treatment to complete the sterilization process.
(c) Filling containers.
(1) The filling of small containers with products shall be done in a sanitary manner. The containers may not contaminate or detract from the quality of the product in any way. After filling, the container shall be hermetically sealed.
(2) Bulk containers for unsterilized products must be suitable and adequate to protect the product in storage or transit. The bulk container, including bulk tankers, shall be cleaned and sanitized before filling, and filled and closed in a sanitary manner.
(d) Aseptic filling. A previously sterilized product shall be filled under conditions which prevent contamination of the product by living organisms or spores. The containers prior to being filled shall be sterilized and maintained in a sterile condition. The containers shall be sealed in a manner that prevents contamination of the product.
(e) Storage. Proper facilities shall be provided for the storage and handling of finished product.
Subchapter F. RAW MILK FOR HUMAN CONSUMPTION Sec.
59a.401. Raw milk; general. 59a.402. Raw milk; prohibitions. 59a.403. Raw milk permit. 59a.404. Requirements for the issuance of a raw milk permit. 59a.405. Sanitation. 59a.406. Animal health. 59a.407. Regular testing of water supply. 59a.408. Regular testing of raw milk for human consumption. 59a.409. Violations of raw milk testing standards. 59a.410. Raw milk packaging. 59a.411. Label content review by the Department. 59a.412. Inspection, sampling and testing by the Department. 59a.413. Enforcement: Suspension or revocation of a raw milk permit. 59a.414. Enforcement: Summary criminal prosecution. 59a.415. Enforcement: Injunctions. 59a.416. Enforcement: Seizure, condemnation, denaturing or destruction of raw milk; exclusion from sale. § 59a.401. Raw milk; general.
This subchapter prescribes the permitting, testing and inspection requirements that are applicable to persons seeking to sell raw milk for human consumption.
§ 59a.402. Raw milk; prohibitions.
(a) Sale of raw milk without permit. A person may not sell raw milk for human consumption without having a current raw milk permit issued by the Department. The term ''sell'' includes the selling, exchanging, delivering or having in possession, care, control or custody with intent to sell, exchange, or deliver or to offer or to expose for sale.
(b) Actions authorized under a raw milk permit. A raw milk permit authorizes the permitholder to lawfully produce and sell (within this Commonwealth) raw whole milk for human consumption. It also authorizes the permitholder to obtain an additional permit, issued by the Department under authority of 21 CFR 133.150 (relating to hard cheeses), authorizing the sale of aged cheese manufactured from raw milk.
(c) Compliance with testing and documentation requirements. A person may not sell raw milk for human consumption without being in compliance with the testing and documentation requirements of this section.
§ 59a.403. Raw milk permit.
(a) Application. A raw milk permit application may be obtained by contacting the Department at the address in § 59a.3 (relating to contacting the Department).
(b) Duration. A raw milk permit will be valid for no more than 1 year. Each raw milk permit will expire as of September 1 each year, unless revoked or suspended earlier by the Department.
(c) Timing of filing to ensure Department review of an application for a successor raw milk permit. If a raw milk permitholder wishes to obtain a raw milk permit to replace an expiring raw milk permit, the permitholder is encouraged, but is not required, to file an application for this successor raw milk permit with the Department by July 1 of the year in which the current raw milk permit is to expire. Compliance with this recommendation may help to prevent a lapse between the expiring raw milk permit and the effective date of the successor raw milk permit.
§ 59a.404. Requirements for the issuance of a raw milk permit.
(a) Preissuance inspection.
(1) New raw milk permits. Prior to issuing a raw milk permit, the Department will inspect the dairy farm that is the subject of a new raw milk permit application to determine whether the dairy farm is in compliance with the act and this chapter. The dairy farm must be in compliance with the applicable provisions of the act, the Food Safety Act and this chapter to be eligible for a raw milk permit.
(2) Successor raw milk permits. If a raw milk permitholder applies to the Department for a successor raw milk permit, the Department may issue the raw milk permit without conducting the dairy farm inspection described in paragraph (1).
(b) Confirmation of tuberculosis-free and brucellosis-free status.
(1) New raw milk permits. An applicant for a new raw milk permit shall provide the Department confirmation that the animal or herd from which the raw milk for human consumption is to be produced has been determined to be free from brucellosis and free from tuberculosis, in accordance with the process in § 59a.406 (relating to animal health). This confirmation shall be provided for the subject dairy farm to be eligible for a raw milk permit.
(2) Successor raw milk permits. An applicant for a successor raw milk permit shall, at intervals of no greater than 13 months, provide the Department confirmation that the animal or herd from which the raw milk for human consumption is to be produced has been determined to be free from brucellosis and tuberculosis by annual tests in accordance with the process in § 59a.406.
(c) General herd health.
(1) New raw milk permits. An applicant for a new raw milk permit shall have a licensed veterinarian examine the animal or herd and provide the Department a written report of this examination. The report must reflect that, upon physical examination, the subject animals are in apparent good health and free from evidence of communicable disease. This shall be done in accordance with § 59a.406.
(2) Successor raw milk permits. An applicant for a successor raw milk permit shall provide the Department a copy of a veterinary examination report as described in paragraph (1). The report must be dated within 1 year preceding the date of the application, and reflect that the herd is in general good health and free from communicable disease. The applicant shall continue to have this veterinary examination conducted on an annual basis, in accordance with § 59a.406.
(d) Confirmation of safe water supply.
(1) New raw milk permits. An applicant for a new raw milk permit shall have the dairy farm water supply tested and provide the Department with confirmation that the water is bacteriologically safe, in accordance with § 59a.407 (relating to regular testing of water supply). Water is bacteriologically safe if it meets the requirements in § 59a.405(8) (relating to sanitation) and § 59a.407. The requirement of a bacteriologically safe water supply is also applicable to recirculated cooling water if the dairy farm uses a recirculated cooling water system for milk cooling. Confirmation that the water supply is bacteriologically safe shall be provided for the subject dairy farm to be eligible for a raw milk permit. If the water supply is through a public or municipal water system, this testing requirement does not apply.
(2) Successor raw milk permits. An applicant for a successor raw milk permit shall provide the Department with a copy of a written laboratory report as described in paragraph (1). The report must be dated no earlier than 6 months preceding the date of the application, done in accordance with § 59a.407 and reflect that the dairy farm water supply is bacteriologically safe. Water is bacteriologically safe if it meets the requirements in §§ 59a.405(8) and 59a.407.
(e) Sampling and testing.
(1) New raw milk permits. An applicant for a new raw milk permit shall demonstrate its ability to produce raw milk for human consumption through the following process:
(i) The applicant shall have an approved sampler draw three separate samples of commingled milk from the bulk tank. The samples shall be drawn at least 7 days apart, and be taken on an unannounced basis.
(ii) Each of these three samples described in subparagraph (i) shall be submitted to a Pennsylvania-approved dairy laboratory or the Department for analysis.
(iii) The analysis described in subparagraph (ii) will determine whether the sample meets the standards in § 59a.408 (relating to regular testing of raw milk for human consumption).
(iv) If any of the three analyzed samples described in subparagraph (iii) violates or exceeds a standard in § 59.408, the three-sample process shall repeat itself until three successive samples are in compliance with the referenced standards.
(v) If the first of the three required samples is tested as described in subparagraph (iii), and concludes that no pathogenic bacteria are present, the second and third samples need not be tested for the presence of pathogenic bacteria. If a sample test concludes that pathogenic bacteria are present, a raw milk permit will not be issued until two separate consecutive tests, from samples drawn at least 7 days apart, conclude that no pathogenic bacteria are present.
(2) Successor raw milk permits. An applicant for a successor raw milk permit shall demonstrate its ability to produce raw milk for human consumption through the regular sampling and testing process described in § 59.408.
§ 59a.405. Sanitation.
A raw milk permitholder shall maintain and operate the subject dairy operation in compliance with the same sanitation and handling standards that are applicable to the production of milk for pasteurization, as set forth in § 59a.19 (relating to standards for Grade ''A'' milk for pasteurization, ultra-pasteurization or aseptic processing) except to the extent any of those provisions are inconsistent with this subchapter. The provisions of the Grade ''A'' PMO, in particular the Standards for Grade ''A'' Raw Milk for Pasteurization, Ultrapasteurization or Aseptic Processing and section 7, regarding standards for Grade ''A'' milk and milk products, are incorporated by reference as regulations authorized under the act, to the extent they do not conflict with the act or this subchapter. This includes the items listed under the referenced Grade ''A'' PMO provisions, including the following:
(1) Item 1r. Abnormal milk.
(2) Item 2r. Milking Barn, Stable or Parlor—Construction.
(3) Item 3r. Milking Barn, Stable or Parlor—Cleanliness.
(4) Item 4r. Cowyard.
(5) Item 5r. Milkhouse—Construction and Facilities.
(6) Item 6r. Milkhouse—Cleanliness.
(7) Item 7r. Toilet.
(8) Item 8r. Water Supply, with the additional requirement that a plate heat exchanger or tubular cooler installed and in use on a dairy farm shall be equipped with a backflow prevention device.
(9) Item 9r. Utensils and Equipment—Construction.
(10) Item 10r. Utensils and Equipment—Cleaning.
(11) Item 11r. Utensils and Equipment—Sanitization.
(12) Item 12r. Utensils and Equipment—Storage.
(13) Item 13r. Milking—Flanks, Udders and Teats.
(14) Item 14r. Protection from Contamination.
(15) Item 15r. Drug and Chemical Control.
(16) Item 16r. Personnel—Handwashing Facilities.
(17) Item 17r. Personnel—Cleanliness.
(18) Item 18r. Raw Milk Cooling, with the exception that milk for pasteurization shall be cooled to 4° C (40° F) within 2 hours after the completion of milking.
(19) Item 19r. Insect and Rodent Control.
§ 59a.406. Animal health.
(a) General. A raw milk permitholder shall monitor the health of the animals from which the raw milk for human consumption is produced to ensure that they are in general good health and free of tuberculosis and brucellosis.
(b) Confirmation of brucellosis-free status. A raw milk permitholder shall, at intervals of no greater than 13 months, provide the Department confirmation from a licensed veterinarian that the animal or herd from which the raw milk for human consumption is produced has been determined to be free from brucellosis by annual blood tests conducted in accordance with Chapter 7 (relating to brucellosis regulations).
(c) Annual confirmation of tuberculosis-free status. A raw milk permitholder shall, at intervals of no greater than 13 months, provide the Department confirmation from a licensed veterinarian that the animal or herd from which the raw milk for human consumption is produced has been determined to be free from tuberculosis by annual tests conducted in accordance with Chapter 9 (relating to control and eradication of tuberculosis of livestock).
(d) Annual veterinary examination. A raw milk permitholder shall, at intervals of no more than 1 year, have a licensed veterinarian examine the herd and issue a written report of this examination. The report must reflect that, upon physical examination, the herd is in apparent good health and free from evidence of communicable disease. The raw milk permitholder shall retain a copy of the written veterinarian's report for at least 3 years and, upon request of the Department, make the report available for inspection.
§ 59a.407. Regular testing of water supply.
(a) General requirement of safe and sanitary water. The water supply for a dairy operation that produces raw milk for human consumption under a raw milk permit must be safe and sanitary.
(b) Testing frequency. The water supply for a dairy operation that produces raw milk for human consumption under a raw milk permit shall be tested at least once every 6 months, and whenever any repair or alteration is made to the water supply system. This testing shall be at the raw milk permitholder's expense. If the water supply is through a public or municipal water system, this testing requirement does not apply.
(c) Testing standards. The water tests described in this section shall be conducted at a qualified laboratory. The testing must include bacteriological examinations to determine whether the water is bacteriologically safe. Water is bacteriologically safe if it meets the requirements in §§ 59a.405(8) and 59a.407 (relating to sanitation; and regular testing of water supply). The requirement of a bacteriologically safe water supply is also applicable to recirculated cooling water if the dairy farm uses a recirculated cooling water system for milk cooling. The water supply must contain a Most Probable Number of Coliform Organisms (MPN) of less than 2.2-per-100-milliliters by the multiple tube fermentation method or less than 1-per-100-milliliters by the membrane filter technique or the chromogenic substrate technique. The water must otherwise be safe and sanitary.
(d) Water test records. The raw milk permitholder shall retain all records of required water tests for 1 year and make these available for inspection upon request of the Department.
§ 59a.408. Regular testing of raw milk for human consumption.
(a) Responsibility. A raw milk permitholder shall be responsible to arrange for the regular sampling and testing required with respect to the raw milk permit, and to pay for this testing.
(b) Testing laboratories. Raw milk samples submitted for testing shall be analyzed at an official laboratory or a Pennsylvania-approved dairy laboratory.
(c) Testing schedule and standards. A raw milk permitholder shall coordinate the testing of raw milk for human consumption on the following schedule, and the raw milk samples must meet the following standards:
Raw Milk Testing Schedule and Standards
Required Action Interval Type of Action or Test Required Standard At all times Maintain raw milk temperature in accordance with raw milk temperature standards. Raw milk shall be cooled to 40° F (4° C) or less within 2 hours after milking, provided that the blend temperature after the first and subsequent milking does not exceed 50° F (10° C). At least twice each month, in conjunction with the tests for coliform count and for the presence of drugs (including growth inhibitors), described in this subsection Bacterial count Bacteria may not be present in excess of 20,000 per milliliter. Note: Tested in conjunction with a drug residue/ inhibitory substance test. At least twice each month, in conjunction with the tests for bacterial count and for the presence of drugs (including growth inhibitors), described in this subsection Coliform count Coliform may not exceed 10 per milliliter. Note: Tested in conjunction with a drug residue/ inhibitory substance test. At least twice each month Somatic cell count The somatic cell count may not exceed 750,000/milliliter (1,500,000/ml for goat milk). At least twice each month, in conjunction with the tests for bacterial count and for coliform count, described in this subsection Test for presence of drugs (including growth inhibitors) There may be no positive results for drug residue, using drug residue detection laboratory techniques referenced in the current Grade ''A'' Pasteurized Milk Ordinance developed by the United States Department of Health and Human Services, Food and Drug Administration. Once every 6 months From a sample drawn from the bulk tank, test for presence of the following pathogenic bacteria: Salmonellae, Listeria monocytogenes, Camphylobacter and E. Coli 0157:H7 There may be no pathogenic bacteria present.
§ 59a.409. Violations of raw milk testing standards.
(a) Bacterial count, somatic cell count, coliform count or cooling temperature tests.
(1) If two of the last four tested raw milk samples exceed the bacterial count, somatic cell count or coliform count standards or cooling temperature requirements described in § 59a.408 (relating to regular testing of raw milk for human consumption), the Department will provide the raw milk permitholder with written notice that it is in violation of the act and this chapter.
(2) If three of the last five tested raw milk samples exceed the bacterial count, somatic cell count or coliform count standards or cooling temperature requirements in § 59a.408, the Department will proceed to revoke or suspend the raw milk permit, and the raw milk permitholder may be subject to summary criminal prosecution under the act.
(b) Pesticides. If a raw milk sample tests positive for the presence of a pesticide at or above actionable levels established for the pesticide the United States Environmental Protection Agency, the raw milk permitholder shall:
(1) Immediately cease the sale of raw milk for human consumption.
(2) Take a second sample and submit it for testing for pesticide residue.
(3) Investigate and determine the cause of the contamination, report the result of that investigation to the Department, and correct that cause of contamination.
(4) Refrain from selling raw milk for human consumption until and unless the second test shows the sample to be free of pesticide residue, or to be below the actionable levels established for the residue by the United States Environmental Protection Agency, and the Department reviews these test results and approves the resumption of raw milk sales.
(c) Drugs. If a raw milk sample tests positive for the presence of a drug, the raw milk permitholder shall:
(1) Immediately cease the sale of raw milk for human consumption.
(2) Investigate and determine the cause of the contamination, report the result of the investigation to the Department and correct the cause of contamination.
(3) Have a second sample collected by an approved sampler and tested at a Pennsylvania-approved dairy laboratory.
(4) Refrain from selling raw milk for human consumption until the second test shows the sample to be free of drug residue, and the Department reviews these test results and approves the resumption of raw milk sales.
(d) Disease-producing organisms. If a raw milk sample tests positive for the presence of pathogenic bacteria or other disease-producing organisms such as Salmonellae, Listeria monocytogenes, Camphylobacter or E. Coli 0157:H7, the raw milk permitholder shall do the following:
(1) Immediately cease the sale of raw milk for human consumption.
(2) Investigate and determine the cause of the contamination, report the result of that investigation to the Department, and correct that cause of contamination.
(3) Wait at least 2 days from the cessation of raw milk sales, and then have an approved sampler collect a sample and submit it to a Pennsylvania-approved dairy laboratory to be tested for the presence of pathogenic bacteria.
(4) Following the initial sampling described in the preceding requirement, have an approved sampler collect an additional sample, at least 1 day after the previous sample, and submit it to a Pennsylvania-approved dairy laboratory for testing for the presence of pathogenic bacteria.
(5) Refrain from selling raw milk for human consumption until and unless two consecutive tests, from samples drawn at least 1 day apart, show that raw milk produced at the dairy operation that is the subject of the raw milk permit is free from disease-producing organisms, and the Department reviews these test results and approves the resumption of raw milk sales.
§ 59a.410. Raw milk packaging.
(a) Sales or delivery on premises other than the farm where the raw milk for human consumption is produced. When raw milk for human consumption is packaged for sale or delivery at a location other than the farm where the raw milk for human consumption is produced, bottling and capping, or the filling and closure of containers other than bottles, shall be conducted in a room separate from the milk room by a mechanical means of filling and capping bottles or by a mechanical means of filling and closure of containers other than bottles. The closure must protect the pouring lip to its largest diameter.
(b) Sales or delivery on premises where the raw milk for human consumption is produced. When raw milk for human consumption is packaged for sale or delivery at the location where the raw milk for human consumption is produced, the Department will consider a milk room facility as being adequate for bottling and capping, or the filling and closure of containers other than bottles. This activity shall be completed in a sanitary manner using easily cleanable equipment that has been cleaned and sanitized.
(c) Additional sanitation requirements. Containers shall be filled and closed without any part of the hand coming in contact with the inner surface of the bottle or container or in contact with bottle caps. Containers may not be filled by the customer. Caps shall be obtained from sanitary containers and kept in sanitary containers until used. Containers shall be stored in a clean and dry area off the floor and protected from any source of contamination. Washing of returnable bottles or containers shall be conducted in a room that is separate from any room that is devoted to bottling and capping or the filling and closure of containers other than bottles.
§ 59a.411. Label content review by the Department.
(a) Raw milk in containers owned by the raw milk permitholder.
(1) General label statements. If raw milk for human consumption is prepackaged for sale in containers that are owned by the raw milk permitholder, the labeling on these containers and caps shall be submitted to the Department and approved by the Department prior to use in commerce. The container must be labeled as raw milk, and include the fluid volume as well as the name and address of the distributor or producer and the words ''Keep Refrigerated.'' It may not be misbranded or contain any false or misleading statements. The Department will, within 10 business days of receiving a complete application for label approval, mail the applicant its written approval or denial of the label.
(i) If the application is denied, the written denial will set forth the basis for denial and afford the applicant notice and opportunity for an administrative hearing on the denial.
(ii) If the application is granted, the written approval will contain a copy of the label and assign a unique serial number to each label approved under the application. The Department will retain copies of these approvals.
(2) Consumer advisory for raw animal-derived foods that have not been processed to remove pathogens. In addition to the information in paragraph (1), the label must contain a consumer advisory statement to notify consumers of the increased risks (particularly to certain highly susceptible populations) associated with the consumption of raw animal-derived foods that have not been processed to remove pathogens. An acceptable notice would be as follows:
Raw milk has not been processed to remove pathogens that can cause illness. The consumption of raw milk may significantly increase the risk of foodborne illness in persons who consume it—particularly with respect to certain highly-susceptible populations such as preschool-age children, older adults, pregnant women, persons experiencing illness, and other people with weakened immune systems.(3) Label requirement: milk dating.
(i) Requirement. The cap of the raw milk container, or the container itself, must be conspicuously and legibly marked in a contrasting color with the designation of the ''sell-by'' date—the month and day of the month after which the raw milk may not be sold or offered for sale. The designation may be numerical—such as ''8-15''—or with the use of an abbreviation for the month, such as ''AUG 15'' or ''AU 15.'' The words ''Sell by'' or ''Not to be sold after'' must precede the designation of the date, or the statement ''Not to be sold after the date stamped above'' must appear legibly on the container. This designation of the date may not exceed 17 days beginning after midnight on the day on which the raw milk was produced.
(ii) Prominence of sell-by date on label. The sell-by date must be separate and distinct from any other number, letter or intervening material on the cap or container.
(iii) Prohibition. Raw milk may not be sold or offered for sale for human consumption if the raw milk is sold or offered for sale after the sell-by date designated on the container.
(iv) Monitoring by the Department.
(A) The Department will periodically sample containers of raw milk for human consumption in the possession of the raw milk permitholder or a distributor. This sampling may occur at any time before the raw milk is delivered to the customer. The Department will take at least one sample of raw milk from each raw milk permitholder each calendar year.
(B) The samples described in clause (A) shall be analyzed by the Department or a Pennsylvania-approved dairy laboratory, to determine whether bacterial test results exceed the bacterial limits for raw milk described in the Raw Milk Testing Schedule and Standards in § 59a.408 (relating to regular testing of raw milk for human consumption) prior to the expiration of the sell-by date designated on the raw milk container.
(C) When two or more samples demonstrate a raw milk permitholder cannot produce raw milk for human consumption that remains consistently within the bacterial limits referenced in clause (B) through the sell-by date marked on the container, the Department will require a raw milk permitholder to use a shorter sell-by date specified by the Department. The Department will calculate this revised sell-by date so that bacterial growth in the raw milk will not exceed the referenced bacterial limits within that sell-by period if the raw milk is maintained in accordance with the temperature requirements for raw milk in the Raw Milk Testing Schedule and Standards in § 59a.408.
(D) A raw milk permitholder may submit samples to the Department for analysis to obtain approval to resume a specific sell-by period for the raw milk sampled. The Department will approve resumption of a specific sell-by period when analysis of a sample demonstrates that bacterial growth in the raw milk will not exceed the referenced bacterial limits within that sell-by period if the raw milk is maintained in accordance with the temperature requirements for raw milk in the Raw Milk Testing Schedule and Standards in § 59a.408.
(b) Raw milk in customer-owned containers.
(1) Container labeling and caps. If raw milk for human consumption is packed for sale in containers that are owned by the consumer, Departmental review of the labeling on the container or caps is not required. The Department recommends, but does not require, that customer owned containers be clean, food-grade containers of 1 gallon or smaller capacity.
(2) Consumer advisory. If raw milk for human consumption is packed for sale in containers that are owned by the consumer, the raw milk permitholder shall post a consumer advisory at the location where the customer owned containers are filled, or in close proximity to that location, to provide consumers notice of increased risks associated with the consumption of raw animal-derived foods that have not been processed to remove pathogens by certain highly susceptible populations. An acceptable notice would be as described in subsection (a)(2).
§ 59a.412. Inspection, sampling and testing by the Department.
A raw milk permitholder shall allow the Department and its personnel to inspect the dairy operation that is the subject of the permit, review records, draw samples, conduct tests and take other actions necessary to the Department's performance of its responsibilities under the act, the Food Safety Act or any other applicable statute or regulation. If a raw milk permitholder fails to allow this inspection and sampling by the Department, the Department may take steps to revoke or suspend the raw milk permit.
§ 59a.413. Enforcement: Suspension or revocation of a raw milk permit.
(a) General. The Department may take action to suspend or revoke a raw milk permit if a permitholder does not comply with the act or this chapter.
(b) Procedure.
(1) The act requires that the Department provide a raw milk permitholder with at least 5 days advance written notice of a raw milk permit revocation or suspension. This written notice will be sent by certified mail. The Department may supplement the notice by providing the permitholder the written notice by personal service or other means. The written notice must specify the procedure by which the permitholder may request an administrative hearing and the 5-day window within which a written request for an administrative hearing shall be submitted to the Department.
(2) If the basis for a proposed raw milk permit suspension or revocation is that pathogenic bacteria have been detected in the raw milk, or foreign substances are present in the raw milk, or any condition exists when consumption of raw milk produced and sold prior to revocation or suspension of the raw milk permit may pose a threat to the health or safety of those persons who consume it, the Department will immediately notify the raw milk permitholder and request that it voluntarily cease all sales of raw milk—without regard to whether the raw milk permitholder has received the 5 days advance written notice required under the act. The requirements of this paragraph do not alter the obligation of a raw milk permitholder to cease sales of raw milk for human consumption if required under § 59a.409 (relating to violations of raw milk testing standards).
(i) If a raw milk permitholder complies with a request that it voluntarily cease raw milk sales, the Department will consider this cooperation a mitigating factor as it determines any penalty or sanction relating to the violation.
(ii) If a raw milk permitholder does not choose to comply with a request that it voluntarily cease raw milk sales, the Department will do the following:
(A) Apprise the Department of Health and any local health department having jurisdiction of the situation, and recommend these entities take lawful action to ensure that sales of raw milk cease.
(B) Consult with the Office of Attorney General regarding whether it should institute legal action to obtain an injunction to prohibit the raw milk sales.
(C) Arrange for an administrative hearing before a hearing examiner, if the raw milk permitholder has been afforded written notice and opportunity for a hearing on the proposed suspension or revocation and requests a hearing on the proposed permit suspension or revocation.
(D) Issue a final adjudication, ordering the suspension or revocation, if the raw milk permitholder does not request a hearing on the proposed permit suspension or revocation.
(E) Recommend to the raw milk permitholder that it inform its customers that it has been asked by the Department to voluntarily cease raw milk sales and provide these customers the basis for the Department's request.
(c) Ownership of raw milk permit. A raw milk permit is and remains the property of the Department even when it is in the physical custody of the permitholder. If a raw milk permit is suspended or revoked, and the permitholder has been afforded written notice and opportunity for a hearing on the proposed suspension or revocation, the person in possession of the raw milk permit shall immediately return or surrender that raw milk permit to the Department. In the case of a permit suspension, the Department will promptly return the raw milk permit to the permitholder at the end of the suspension period.
§ 59a.414. Enforcement: Summary criminal prosecution.
If a raw milk permitholder violates any provision of the act or this chapter, the Department may file a summary prosecution against a raw milk permitholder for the violation. The violation is graded as a summary offense.
§ 59a.415. Enforcement: Injunctions.
The Department may ask the Attorney General to initiate legal action to enjoin a person from selling raw milk for human consumption without the required raw milk permit or from violating the act or this chapter. Violations of an injunction can result in fines or imprisonment, or both.
§ 59a.416. Enforcement: Seizure, condemnation, denaturing or destruction of raw milk; exclusion from sale.
(a) Seizure, condemnation, denaturing or destruction of raw milk. Whenever, in the opinion of the Secretary, a given supply of raw milk or raw milk products is considered unsafe or a menace to public health, the Secretary may seize, condemn, denature or destroy the milk or milk products, without compensation to the owner of the milk or milk products. Examples of circumstances under which raw milk or raw milk products may be unsafe or a menace to public health include situations when raw milk or raw milk products have been produced in violation of the act, the Food Safety Act or this chapter and these violations relate to handling and sanitation, when herd health conditions risk the transmittal of disease through the milk or milk products or when pathogenic bacteria are present in the raw milk permitholder's raw milk supply,
(b) Excluding milk from sale. The Department may exclude raw milk or raw milk products from sale in either of the following circumstances:
(1) The Secretary considers the raw milk or raw milk products to be unsafe or a menace to public health.
(2) If a raw milk permitholder violates a provision of the act or this chapter.
Subchapter G. MISCELLANEOUS PROVISIONS Sec.
59a.501. Interrelatedness with Food Safety Act. § 59a.501. Interrelatedness with Food Safety Act.
The subject matter of the act and this chapter overlaps with the subject matter of the Food Act (repealed) and the regulations promulgated under authority of that statute in Chapter 46 (relating to food code). This chapter does not restrict, prevent or limit the Department or any other government entity from exercising authority under the Food Safety Act or its attendant regulations with respect to milk, milk products, manufactured dairy products or any other foods.
[Pa.B. Doc. No. 11-844. Filed for public inspection May 20, 2011, 9:00 a.m.]
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