[33 Pa.B. 6137]
[Continued from previous Web Page]
Subchapter F. PHYSICAL FACILITIES MATERIALS FOR CONSTRUCTION AND REPAIR
Sec.
46.901. Indoor areas of food facilities: surface characteristics. 46.902. Outdoor areas of food facilities: surface characteristics. DESIGN, CONSTRUCTION AND INSTALLATION
46.921. Cleanability of floors, walls and ceilings. 46.922. Functionality of various physical facilities of a food facility. NUMBERS AND CAPACITIES
46.941. Handwashing facilities: numbers and capacities. 46.942. Toilets and urinals: numbers and capacities. 46.943. Lighting: intensity. 46.944. Mechanical ventilation as needed. 46.945. Requirement and designation of dressing areas and storage areas. 46.946. Utility sinks. LOCATION AND PLACEMENT
46.961. Handwashing facilities: located for convenience. 46.962. Toilet rooms: located for convenience. 46.963. Employee accommodations: located to prevent contamination. 46.964. Distressed merchandise: segregated. 46.965. Refuse, recyclables and returnables: receptacles, waste handling units and designated storage areas. MAINTENANCE AND OPERATION
46.981. Premises, structures, attachments and fixtures: methods. 46.982. Limitations on animals.
MATERIALS FOR CONSTRUCTION AND REPAIR § 46.901. Indoor areas of food facilities: surface characteristics.
(a) General requirement. Except as specified in subsection (b), materials for indoor floor, wall and ceiling surfaces of a food facility under conditions of normal use shall be all of the following:
(1) Smooth, durable and easily cleanable for areas where food facility operations are conducted.
(2) Closely woven and easily cleanable carpet for carpeted areas.
(3) Nonabsorbent for areas subject to moisture such as food preparation areas, walk-in refrigerators, warewashing areas, toilet rooms, mobile food facility servicing areas and areas subject to flushing or spray cleaning methods.
(b) Exception for a temporary food facility.
(1) If graded to drain, a floor in a temporary food facility may be concrete, machine-laid asphalt, or dirt or gravel if it is covered with mats, removable platforms, duckboards or other suitable approved materials that are effectively treated to control dust and mud.
(2) Walls and ceilings in a temporary food facility shall be constructed of a material that protects the interior from the weather and windblown dust and debris.
§ 46.902. Outdoor areas of food facilities: surface characteristics.
(a) Walking and driving areas. The outdoor walking and driving areas of a food facility shall be surfaced with concrete, asphalt, gravel or other materials that have been effectively treated to minimize dust, facilitate maintenance and prevent muddy conditions.
(b) Exterior surfaces. Exterior surfaces of food facility buildings and mobile food facilities shall be of weather-resistant materials and shall comply with Chapter 3 of the Pennsylvania Construction Code Act (35 P. S. §§ 7210.301--7210.304).
(c) Certain outdoor storage areas. Outdoor storage areas of a food facility used for storing refuse, recyclables or returnables shall be of materials specified in § 46.881(b) and (c) (relating to storage areas and receptacles for refuse, recyclables and returnables: materials, design, construction and installation).
DESIGN, CONSTRUCTION AND INSTALLATION § 46.921. Cleanability of floors, walls and ceilings.
(a) General requirement. Except as specified in subsection (d), the floors, floor coverings, walls, wall coverings and ceilings of a food facility shall be designed, constructed and installed so they are smooth and easily cleanable, except that antislip floor coverings or applications may be used for safety reasons.
(b) Utility lines.
(1) Utility service lines and pipes in a food facility may not be unnecessarily exposed.
(2) Exposed utility service lines and pipes in a food facility shall be installed so they do not obstruct or prevent cleaning of the floors, walls or ceilings.
(3) Exposed horizontal utility service lines and pipes in a food facility may not be installed on the floor.
(c) Floor and wall junctures: coved and enclosed or sealed.
(1) In food facilities in which cleaning methods other than water flushing are used for cleaning floors, the floor and wall junctures shall be coved and closed to no larger than 1 mm (1/32 inch).
(2) The floors in food facilities in which water flush cleaning methods are used shall be provided with drains and be graded to drain, and the floor and wall junctures shall be coved and sealed.
(d) Floor carpeting: limitations and installation.
(1) A floor covering such as carpeting or similar material may not be installed as a floor covering in food preparation areas, walk-in refrigerators, warewashing areas, toilet room areas where handwashing sinks, toilets and urinals are located, refuse storage rooms or other areas where the floor is subject to moisture, flushing or spray cleaning methods.
(2) If carpeting is installed as a floor covering in areas other than those specified in paragraph (1), it shall be both of the following:
(i) Securely attached to the floor with a durable mastic by using a stretch and tack method, or by another method.
(ii) Installed tightly against the wall under the coving or installed away from the wall with a space between the carpet and the wall and with the edges of the carpet secured by metal stripping or some other means.
(e) Floor covering: mats and duckboards. Mats and duckboards in a food facility shall be designed to be removable and easily cleanable.
(f) Wall and ceiling coverings and coatings.
(1) Wall and ceiling covering materials in a food facility shall be attached so that they are easily cleanable.
(2) Except in areas used only for dry storage, concrete, porous blocks or bricks used for indoor wall construction in a food facility shall be finished and sealed to provide a smooth, nonabsorbent, easily cleanable surface.
(g) Attachments to walls and ceilings. Attachments to walls and ceilings (such as light fixtures, mechanical room ventilation system components, vent covers, wall mounted fans, decorative items and other attachments) in a food facility shall be easily cleanable, except that in a consumer area of a food facility, wall and ceiling surfaces and decorative items and attachments that are provided for ambiance need not meet this requirement if they are kept clean.
(h) Studs, joists and rafters in walls and ceilings. Studs, joists and rafters in a food facility may not be exposed in areas subject to moisture. This requirement does not apply to temporary food facilities.
§ 46.922. Functionality of various physical facilities of a food facility.
(a) Light bulbs: protective shielding.
(1) Except as specified in paragraph (2), light bulbs in use in a food facility shall be shielded, coated or otherwise shatter-resistant in areas where there is exposed food; clean equipment, utensils and linens; or unwrapped single-service and single-use articles.
(2) Shielded, coated or otherwise shatter-resistant bulbs need not be used in areas used only for storing food in unopened packages, if both of the following are accurate:
(i) The integrity of the packages cannot be affected by broken glass falling onto them.
(ii) The packages are capable of being cleaned of debris from broken bulbs before the packages are opened.
(3) An infrared or other heat lamp shall be protected against breakage by a shield surrounding and extending beyond the bulb so that only the face of the bulb is exposed.
(b) Heating, ventilating and air conditioning system vents. Heating, ventilating and air conditioning systems in a food facility shall be designed and installed so that make-up air intake and exhaust vents do not cause contamination of food, food-contact surfaces, equipment or utensils.
(c) Design and installation of insect control devices.
(1) Insect control devices that are used in a food facility to electrocute or stun flying insects shall be designed to retain the insect within the device.
(2) Insect control devices shall be installed so that they meet the following requirements:
(i) The devices are not located over a food preparation area.
(ii) Dead insects and insect fragments are prevented from being impelled onto or falling on exposed food; clean equipment, utensils and linens; and unwrapped single-service and single-use articles.
(d) Toilet rooms shall be enclosed. A toilet room located on the premises of a food facility shall be completely enclosed and provided with a tight-fitting and self-closing door. This requirement does not apply to a toilet room that is located outside a food facility and does not open directly into the food facility (such as a toilet room that is provided by the management of a shopping mall).
(e) Outer openings shall be protected.
(1) Except as specified in paragraphs (2)--(5), outer openings of a food facility shall be protected against the entry of insects and rodents by use of the following:
(i) Filling or closing holes and other gaps along floors, walls and ceilings.
(ii) Having closed, tight-fitting windows.
(iii) Having solid, self-closing, tight-fitting doors.
(2) Paragraph (1) does not apply if a food facility opens into a larger structure, such as a mall, airport or office building, or into an attached structure, such as a porch, and the outer openings from the larger or attached structure are protected against the entry of insects and rodents.
(3) Exterior doors used as exits need not be self-closing if they are all of the following:
(i) Solid and tight-fitting.
(ii) Designated for use only when an emergency exists, and limited so they are not used for entrance or exit from the building for purposes other than the designated emergency exit use.
(4) Except as specified in paragraphs (2) and (5), if the windows or doors of a food facility, or of a larger structure within which a food facility is located, are kept open for ventilation or other purposes or a temporary food facility is not provided with windows and doors as specified in paragraph (1), the openings shall be protected against the entry of insects and rodents by one or more of the following:
(i) 16 mesh to 25.4mm (16 mesh to 1 inch) screens.
(ii) Properly designed and installed air curtains to control flying insects.
(iii) Other effective means.
(5) Paragraph (4) does not apply if insects, rodents and other animals are absent due to the location of the facility, the weather or other limiting condition.
(f) Exterior walls and roofs: protective barrier. Perimeter walls and roofs of a food facility shall effectively protect the facility from the weather and the entry of insects, rodents and other animals.
(g) Outdoor food vending areas, overhead protection. If located outside, a machine used to vend food shall be provided with overhead protection except that machines vending canned beverages need not meet this requirement.
(h) Outdoor servicing areas: overhead protection. Servicing areas of a food facility shall be provided with overhead protection. However, if the area is used only for the loading of water or the discharge of sewage and other liquid waste, through the use of a closed system of hoses, the area need not be provided with overhead protection.
(i) Outdoor walking and driving surfaces: graded to drain. Exterior walking and driving surfaces of a food facility shall be graded to drain.
(j) Outdoor refuse areas: curbed and graded to drain. Outdoor refuse areas shall be constructed in accordance with Chapter 3 of the Pennsylvania Construction Code Act (35 P. S. §§ 7210.301--7210.304) and shall be curbed and graded to drain to collect and dispose of liquid waste that results from the refuse and from cleaning the area and waste receptacles.
(k) Living or sleeping quarters, use prohibition. A room used as living or sleeping quarters, or an area directly opening into a room used as living or sleeping quarters, may not be used for conducting food facility operations.
(l) Living or sleeping quarters: separation. Living or sleeping quarters located on the premises of a food facility such as those provided for lodging registration clerks or resident managers shall be separated from rooms and areas used for food facility operations by complete partitioning and solid self-closing doors.
NUMBERS AND CAPACITIES § 46.941. Handwashing facilities: numbers and capacities.
(a) Minimum number. Handwashing facilities shall be provided in a food facility as specified in § 46.823(a) (relating to numbers and capacities of plumbing facilities).
(b) Availability of handwashing cleanser. Each handwashing sink or group of two adjacent sinks shall be provided with a supply of hand cleaning liquid, powder or bar soap.
(c) Availability of hand drying. Each handwashing sink or group of adjacent sinks shall be provided with one or more of the following:
(1) Individual, disposable towels.
(2) A continuous towel system that supplies the user with a clean towel.
(3) A heated-air hand drying device.
(d) Limitations on use of handwashing aids and devices. A sink used for food preparation or utensil washing, or a utility sink or curbed cleaning facility used for the disposal of mop water or similar wastes, may not be provided with the handwashing aids and devices required for a handwashing sink as specified in subsections (b) and (c) and § 46.882(a)(3) (relating to storage areas and receptacles for refuse, recyclables and returnables: numbers and capacities).
(e) Handwashing signage. A sign or poster that notifies food employees to wash their hands shall be provided at all handwashing sinks used by food employees and shall be clearly visible to food employees.
(f) Disposable towels, waste receptacle. A handwashing sink or group of adjacent sinks that is provided with disposable towels shall be provided with a waste receptacle as specified in § 46.882(a)(3).
§ 46.942. Toilets and urinals: numbers and capacities.
(a) Minimum number. Toilets and urinals shall be provided in a food facility as specified in § 46.823(b) (relating to numbers and capacities of plumbing facilities).
(b) Availability of toilet tissue. A supply of toilet tissue shall be available at each toilet.
§ 46.943. Lighting: intensity.
The light intensity in a food facility shall be all of the following:
(1) At least 110 lux (10 foot candles) at a distance of 75 cm (30 inches) above the floor, in walk-in refrigeration units and dry food storage areas and in other areas and rooms during periods of cleaning.
(2) At least 220 lux (20 foot candles) at each of the following locations:
(i) At a surface where food is provided for consumer self-service such as buffets and salad bars or where fresh produce or packaged foods are sold or offered for consumption.
(ii) Inside equipment such as reach-in and under-counter refrigerators.
(iii) At a distance of 75 cm (30 inches) above the floor in areas used for handwashing, warewashing and equipment and utensil storage, and in toilet rooms.
(3) At least 540 lux (50 foot candles) at a surface where a food employee is working with food or working with utensils or equipment such as knives, slicers, grinders or saws where employee safety is a factor.
§ 46.944. Mechanical ventilation as needed.
If necessary to keep rooms free of excessive heat, steam, condensation, vapors, obnoxious odors, smoke and fumes in a food facility, mechanical ventilation of sufficient capacity shall be provided.
§ 46.945. Requirement and designation of dressing areas and storage areas.
(a) Designation. Dressing rooms or dressing areas shall be designated in a food facility if employees routinely change their clothes in that facility.
(b) Storage of employees' clothing and possessions. Lockers or other suitable facilities shall be provided for the orderly storage of employees' clothing and other possessions.
§ 46.946. Utility sinks.
A utility sink or curbed cleaning facility shall be provided as specified in § 46.823(c) (relating to numbers and capacities of plumbing facilities).
LOCATION AND PLACEMENT § 46.961. Handwashing facilities: located for convenience.
Handwashing facilities in a food facility shall be conveniently located as specified in § 46.824(a) (relating to location and placement of plumbing facilities).
§ 46.962. Toilet rooms: located for convenience.
Toilet rooms in a food facility shall be conveniently located and accessible to employees during all hours of operation.
§ 46.963. Employee accommodations: located to prevent contamination.
(a) Designated eating, drinking and smoking areas. Areas designated for employees to eat, drink and use tobacco shall be located so that food, equipment, linens and single-service and single-use articles are protected from contamination.
(b) Lockers and other facilities. Lockers or other suitable facilities shall be located in a designated room or area where contamination of food, equipment, utensils, linens and single-service and single-use articles cannot occur.
§ 46.964. Distressed merchandise: segregated.
Products that are held by the food facility operator for credit, redemption or return to the distributor such as damaged, spoiled or recalled products, shall be segregated and held in designated areas that are separate from food, equipment, utensils, linens and single-service and single-use articles.
§ 46.965. Refuse, recyclables and returnables: receptacles, waste handling units and designated storage areas.
Units, receptacles and areas designated for storage of refuse and recyclable and returnable containers shall be located as specified in § 46.883 (relating to location of storage areas, redeeming machines, receptacles and waste handling units).
MAINTENANCE AND OPERATION § 46.981. Premises, structures, attachments and fixtures: methods.
(a) General requirement. The physical facilities of a food facility shall be maintained in good repair.
(b) Cleaning: frequency and limitations.
(1) The physical facilities of a food facility shall be cleaned as often as necessary to keep them clean.
(2) Cleaning shall be done during periods when the least amount of food is exposed such as after closing. This requirement does not apply to cleaning that is necessary due to a spill or other accident.
(c) Cleaning floors by dustless methods.
(1) Except as specified in paragraph (2), only dustless methods of cleaning shall be used (such as wet cleaning, vacuum cleaning, mopping with treated dust mops or sweeping using a broom and dust-arresting compounds).
(2) Spills or drippage on floors that occur between normal floor cleaning times shall be cleaned as follows:
(i) Without the use of dust-arresting compounds.
(ii) In the case of liquid spills or drippage, with the use of a small amount of absorbent compound such as sawdust or diatomaceous earth applied immediately before spot cleaning.
(d) Cleaning ventilation systems without causing contamination, health hazard or nuisance.
(1) Intake and exhaust air ducts shall be cleaned and filters changed so they are not a source of contamination by dust, dirt and other materials.
(2) If vented to the outside, ventilation systems may not create a public health hazard or nuisance or unlawful discharge.
(e) Preventing contamination by cleaning maintenance tools. Food preparation sinks, handwashing sinks and warewashing equipment may not be used for the cleaning of maintenance tools, the preparation or holding of maintenance materials or the disposal of mop water and similar liquid wastes.
(f) Drying mops. After use, mops shall be placed in a position that allows them to air-dry without soiling walls, equipment or supplies.
(g) Absorbent materials on floors: use limitation. Except as specified in subsection (c)(2), sawdust, wood shavings, granular salt, baked clay, diatomaceous earth or similar materials may not be used on floors.
(h) Maintaining and using handwashing facilities. Handwashing facilities shall be kept clean, and maintained and used as specified in § 46.825(a) (relating to operation and maintenance of plumbing facilities).
(i) Closing toilet room doors. Toilet room doors as specified in § 46.922(d) (relating to functionality of various physical facilities of a food facility) shall be kept closed except during cleaning and maintenance operations.
(j) Using dressing rooms and lockers. Dressing rooms shall be used by employees if the employees regularly change their clothes in the facility. Lockers or other suitable facilities shall be used for the orderly storage of employee clothing and other possessions.
(k) Controlling pests. The presence of insects, rodents and other pests shall be controlled to minimize their presence on the premises by all of the following:
(1) Routinely inspecting incoming shipments of food and supplies.
(2) Routinely inspecting the premises for evidence of pests.
(3) Using methods, if pests are found, such as trapping devices or other means of pest control as specified in § 46.1026(b) and (c) (relating to pesticides).
(4) Eliminating harborage conditions.
(l) Removing dead or trapped birds, insects, rodents and other pests. Dead or trapped birds, insects, rodents and other pests shall be removed from control devices and the premises at a frequency that prevents their accumulation, decomposition or the attraction of pests.
(m) Storing maintenance tools. Maintenance tools (such as brooms, mops, vacuum cleaners and similar items) shall be stored so that they do not contaminate food, equipment, utensils, linens and single-service and single-use articles, and in an orderly manner that facilitates cleaning the area used for storing the maintenance tools.
(n) Removing unnecessary items and litter from the premises. The premises of a food facility shall be free of items that are unnecessary to the operation or maintenance of the facility, such as equipment that is nonfunctional or no longer used, and litter.
§ 46.982. Limitations on animals.
(a) General. Live animals may not be allowed on the premises of a food facility, unless under an exception specified in subsection (b).
(b) Exceptions.
(1) Live animals may be allowed only in the following situations, and if the contamination of food; clean equipment, utensils and linens; and unwrapped single-service and single-use articles cannot result:
(i) Edible fish or decorative fish in aquariums, shellfish or crustacea on ice or under refrigeration, and shellfish and crustacea in display tank systems.
(ii) Patrol dogs accompanying police or security officers in offices and dining, sales and storage areas, and sentry dogs running loose in outside fenced areas.
(iii) Service animals that are controlled by the disabled employee or person, in areas that are not used for food preparation and that are usually open for customers (such as dining and sales areas), if a health or safety hazard will not result from the presence or activities of the service animal.
(iv) Pets in the common dining areas of institutional care facilities (such as nursing homes, assisted living facilities, group homes or residential care facilities) at times other than during meals if all of the following are accurate:
(A) Effective partitioning and self-closing doors separate the common dining areas from food storage or food preparation areas.
(B) Condiments, equipment and utensils are stored in enclosed cabinets or removed from the common dining areas when pets are present.
(C) Dining areas including tables, countertops and similar surfaces are effectively cleaned before the next meal service.
(v) Caged animals or animals that are similarly restrained in areas that are not used for food preparation, storage, sales, display or dining, such as in a variety store that sells pets or a tourist park that displays animals.
(2) Live or dead fish bait may be stored if contamination of food, clean equipment, utensils and linens; and unwrapped single-service and single-use articles cannot result.
Subchapter G. POISONOUS OR TOXIC MATERIALS LABELING AND IDENTIFICATION
Sec.
46.1001. Poisonous or toxic substances: original containers to display identifying information. 46.1002. Poisonous or toxic substances: working containers labeled with common name. OPERATIONAL SUPPLIES AND APPLICATIONS
46.1021. Poisonous or toxic substances: storage. 46.1022. Poisonous or toxic substances: limitations on presence and use. 46.1023. Prohibition of use of poisonous or toxic material containers to store food. 46.1024. Chemicals: use criteria. 46.1025. Lubricants that have incidental contact with food: criteria. 46.1026. Pesticides. 46.1027. Medicines. 46.1028. First aid supplies: storage. 46.1029. Other personal care items: storage. STOCK AND RETAIL SALE
46.1041. Storage and display: separation of poisonous or toxic materials from food.
LABELING AND IDENTIFICATION § 46.1001. Poisonous or toxic substances: original containers to display identifying information.
Containers of poisonous or toxic materials and personal care items shall bear a legible manufacturer's label.
§ 46.1002. Poisonous or toxic substances: working containers labeled with common name.
Working containers used for storing poisonous or toxic materials such as cleaners and sanitizers taken from bulk supplies shall be clearly and individually identified with the common name of the material.
OPERATIONAL SUPPLIES AND APPLICATIONS § 46.1021. Poisonous or toxic substances: storage.
Poisonous or toxic materials shall be stored so they cannot contaminate food, equipment, utensils, linens and single-service and single-use articles by taking both of the following measures:
(1) Separating the poisonous or toxic materials by spacing or partitioning.
(2) Locating the poisonous or toxic materials in an area that is not above food, equipment, utensils, linens and single-service or single-use articles. This paragraph does not apply to equipment and utensil cleaners and sanitizers that are stored in warewashing areas for availability and convenience if the materials are stored to prevent contamination of food, equipment, utensils, linens and single-service and single-use articles.
§ 46.1022. Poisonous or toxic substances: limitations on presence and use.
(a) Limitation. Only those poisonous or toxic materials that are required for the operation and maintenance of a food facility, such as for the cleaning and sanitizing of equipment and utensils and the control of insects and rodents, shall be allowed in a food facility. This section does not apply to packaged poisonous or toxic materials that are for retail sale.
(b) Conditions of use. Poisonous or toxic materials shall be used in a lawful manner according to the following:
(1) Manufacturer's use directions included in labeling, and, for a pesticide, manufacturer's label instructions that state that use is allowed in a food facility.
(2) The conditions of certification, if certification is required, for use of the pest control materials.
(3) Additional conditions that may be approved by the Department.
(c) Conditions of application. Poisonous or toxic materials shall be applied so that the following are accurate:
(1) A hazard to employees or other persons is not constituted.
(2) Contamination (including toxic residues due to drip, drain, fog, splash or spray on food, equipment, utensils, linens and single-service and single-use articles) is prevented, and for a restricted-use pesticide, this is achieved by doing all of the following:
(i) Removing the items.
(ii) Covering the items with impermeable covers, or taking other appropriate preventive actions.
(iii) Cleaning and sanitizing equipment and utensils after the application.
(d) Applicator. A restricted use pesticide shall be applied only by an applicator certified in accordance with the Pennsylvania Pesticide Control Act of 1973 (3 P. S. §§ 111.21--111.61) or a person under the direct supervision of a certified applicator.
§ 46.1023. Prohibition of use of poisonous or toxic material containers to store food.
A container previously used to store poisonous or toxic materials may not be used to store, transport or dispense food.
§ 46.1024. Chemicals: use criteria.
(a) Sanitizers. Chemical sanitizers and other chemical antimicrobials applied to food-contact surfaces shall meet the requirements specified in 21 CFR 178.1010 (relating to sanitizing solutions).
(b) Chemicals for washing fruits and vegetables. Chemicals used to wash or peel raw, whole fruits and vegetables shall meet the requirements specified in 21 CFR 173.315 (relating to chemicals used in washing or to assist in the peeling of fruits and vegetables).
(c) Boiler water additives. Chemicals used as boiler water additives shall meet the requirements specified in 21 CFR 173.310 (relating to boiler water additives).
(d) Drying agents.
(1) Drying agents used in conjunction with sanitization shall contain only components that are listed as one or more of the following:
(i) Generally recognized as safe for use in food as specified in 21 CFR 182 (relating to substances generally recognized as safe) or 21 CFR 184 (relating to direct food substances affirmed as generally recognized as safe).
(ii) Generally recognized as safe for the intended use as specified in 21 CFR 186 (relating to indirect food substances affirmed as generally recognized as safe).
(iii) Approved for use as a drying agent under a prior sanction specified in 21 CFR 181 (relating to prior-sanctioned food ingredients).
(iv) Specifically regulated as an indirect food additive for use as a drying agent as specified in 21 CFR Parts 175--178.
(v) Approved for use as a drying agent under the threshold of regulation process established by 21 CFR 170.39 (relating to threshold of regulation for substances used in food-contact articles).
(2) When sanitization is with chemicals, the approval required in paragraph (1)(iii) or (v), or the regulation as an indirect food additive required in paragraph (1)(iv), shall be specifically for use with chemical sanitizing solutions.
§ 46.1025. Lubricants that have incidental contact with food: criteria.
Lubricants shall meet the requirements specified in 21 CFR 178.3570 (relating to lubricants with incidental food contact) if they are used on food-contact surfaces, on bearings and gears located on or within food-contact surfaces, or on bearings and gears that are located so that lubricants may leak, drip or be forced into food or onto food-contact surfaces.
§ 46.1026. Pesticides.
(a) Restricted use pesticides: criteria. Restricted use pesticides specified in § 46.1022(d) (relating to poisonous or toxic substances: limitations on presence and use) shall meet the requirements of a restricted use pesticide as specified in § 128.2 (relating to definitions). This section requires restricted use pesticides be one of the following:
(1) Classified for restricted use under section 3(d) of the Federal Insecticide, Fungicide and Rodenticide Act of 1947 (7 U.S.C.A. § 136a(d)).
(2) A pesticide designated by the Secretary for restricted use under section 7(b)(6) of the Pennsylvania Pesticide Control Act of 1973 (3 P. S. § 111.27(b)(6)).
(b) Rodent bait stations. Rodent bait shall be contained in a covered, tamper-resistant bait station.
(c) Tracking powders: pesticides and nontoxics. A tracking powder pesticide may not be used in a food facility. A nontoxic tracking powder (such as talcum or flour) may be used in a food facility if it will not contaminate food, equipment, utensils, linens and single-service and single-use articles.
§ 46.1027. Medicines.
(a) Limitation and storage.
(1) Only those medicines that are necessary for the health of employees shall be allowed in a food facility. This section does not apply to medicines that are stored or displayed for retail sale.
(2) Medicines that are in a food facility for the employees' use shall be labeled as specified in § 46.1001 (relating to poisonous or toxic substances: original containers to display identifying information) and located to prevent the contamination of food, equipment, utensils, linens and single-service and single-use articles.
(b) Refrigerated medicines: storage. Medicines belonging to employees or to children in a day care center that require refrigeration and are stored in a food refrigerator shall be in compliance with the following:
(1) Stored in a package or container and kept inside a covered, leakproof container that is identified as a container for the storage of medicines.
(2) Located so they are inaccessible to children.
§ 46.1028. First aid supplies: storage.
First aid supplies that are in a food facility for the employees' use shall be both of the following:
(1) Labeled as specified in § 46.1001 (relating to poisonous or toxic substances: original containers to display identifying information).
(2) Stored in a kit or a container that is located to prevent the contamination of food, equipment, utensils, linens and single-service and single-use articles.
§ 46.1029. Other personal care items: storage.
Except as specified in §§ 46.1027(b) and 46.1028 (relating to medicines; and first aid supplies: storage), employees shall store their personal care items in facilities as specified in § 46.945(b) (relating to requirement and designation of dressing areas and storage areas).
STOCK AND RETAIL SALE § 46.1041. Storage and display: separation of poisonous or toxic materials from food.
Poisonous or toxic materials shall be stored and displayed for retail sale so they cannot contaminate food, equipment, utensils, linens and single-service and single-use articles by one or both of the following:
(1) Separating the poisonous or toxic materials by spacing or partitioning.
(2) Locating the poisonous or toxic materials in an area that is not above food, equipment, utensils, linens and single-service or single-use articles.
Subchapter H. ADMINISTRATIVE PROCEDURES ACCESS, APPROVALS AND VARIANCES
Sec.
46.1101. Access to food facilities. 46.1102. Obtaining Department or licensor approval. 46.1103. Variances. PLAN SUBMISSION AND APPROVAL
46.1121. Facility and operating plans. 46.1122. HACCP plans. 46.1123. Confidentiality of trade secrets. 46.1124. Preoperational inspection of construction. REQUIREMENTS FOR OPERATION
46.1141. Requirement: license or registration. 46.1142. Application procedure for appropriate license or registration. 46.1143. Issuance. 46.1144. Conditions of retention: responsibilities of the food facility operator.
ACCESS, APPROVALS AND VARIANCES § 46.1101. Access to food facilities.
After the Department or licensor presents identification, the person in charge shall allow the Department or licensor to determine if the food facility is in compliance with this chapter by allowing access to the facility, allowing inspection and providing information and records specified in this chapter and to which the Department or licensor is entitled under the Public Eating and Drinking Places Law, the Food Act and any other relevant statutory or food regulatory authority during the food facility's hours of operation and other reasonable times if the facility is not open during normal business hours.
§ 46.1102. Obtaining Department or licensor approval.
(a) General. This section describes the process by which a person may obtain an approval from the Department or a licensor required by any other provision of this chapter.
(b) Written request. A person seeking an approval from the Department or a licensor under this chapter shall submit a written request for approval to the entity from which approval is sought. If approval is sought from the Department, the written request shall be mailed or delivered to the following address:
Pennsylvania Department of Agriculture
Bureau of Food Safety and Laboratory Services
Attn: Chief, Division of Food Safety
2301 North Cameron Street
Harrisburg, Pennsylvania 17110-9408(c) Contents of request. The written request for approval described in subsection (b) shall specify the provision of this chapter under which approval is sought, the reason approval is sought and relevant documentation in support of the request.
(d) Processing a request. The Department or licensor will, within 30 days of receipt of a written request for approval under this section, mail or otherwise provide the requester with a written grant or denial of the request, or a specific request for additional information. If a written request for additional information is made, the Department or licensor shall have an additional 30 days from the date it receives the additional information within which to mail or otherwise provide the requester with a written grant or denial of the request.
(e) Standard for approval. The Department or licensor shall grant approval if it determines the approval would not constitute or cause a violation of the Food Act, the Public Eating and Drinking Places Law or this chapter, and that no health hazard would result from the approval.
§ 46.1103. Variances.
(a) Modifications and waivers. The Department may grant a variance by modifying or waiving the requirements of this chapter if--in the opinion of the Department--a health hazard will not result from the variance. If a variance is granted, the Department will retain the information specified in subsection (b) in its records for the food facility.
(b) Documentation of proposed variance and justification. Before a variance from a requirement of this chapter is approved, the information that shall be provided by the person requesting the variance and retained in the Department's file on the food facility includes the following:
(1) A statement of the proposed variance of the chapter requirement citing relevant chapter section numbers.
(2) An analysis of the rationale for how the potential public health hazards addressed by the relevant chapter sections will be alternatively addressed by the proposal.
(3) An HACCP plan--if required as specified in § 46.1122(a)(1) (relating to HACCP plans)--that includes the information specified in § 46.1122(b) as it is relevant to the variance requested.
(c) Conformance with approved procedures. If the Department grants a variance as specified in subsection (a), or an HACCP plan is otherwise required as specified in § 46.1122(a), the food facility operator shall do the following:
(1) Comply with the HACCP plans and procedures that are submitted as specified in § 46.1122(b) and approved as a basis for the modification or waiver.
(2) Maintain and provide to the Department, upon request, records specified in § 46.1122(b)(4) and (5) that demonstrate that the following are routinely employed:
(i) Procedures for monitoring critical control points.
(ii) Monitoring of the critical control points.
(iii) Verification of the effectiveness of an operation or process.
(iv) Necessary corrective actions if there is failure at a critical control point.
PLAN SUBMISSION AND APPROVAL § 46.1121. Facility and operating plans.
(a) When plans are required. A food facility licensing applicant or food facility operator shall have plans and specifications reviewed by the Department or licensor and will submit these properly prepared plans and specifications (as described in subsection (b)) to the Department or licensor for review and approval (using the procedure described in § 46.1142 (relating to application procedure for appropriate license or registration)) before any of the following:
(1) The construction of a food facility.
(2) The conversion of an existing structure for use as a food facility.
(3) The remodeling of a food facility (including installation and use of any new major food equipment for heating, cooling and hot and cold holding food) or a change of type of food facility or food operation if the Department or licensor determines that plans and specifications are necessary to ensure compliance with this chapter.
(4) A change of ownership of a food facility.
(b) Contents of the plans and specifications. The plans and specifications for a food facility shall include (as required by the Department or licensor based on the type of operation, type of food preparation and foods prepared) the following information to demonstrate conformance with this chapter:
(1) Intended menu and consumer advisory intentions, if a consumer advisory is required under § 46.423 (relating to consumer advisory required with respect to animal-derived foods that are raw, undercooked or not otherwise processed to eliminate pathogens).
(2) Anticipated volume of food to be stored, prepared and sold or served.
(3) Proposed layout, mechanical schematics, construction materials and finish schedules.
(4) Proposed equipment types, manufacturers, model numbers, locations, dimensions, performance capacities and installation specifications.
(5) Source of water supply, means of sewage disposal and refuse disposal.
(6) An HACCP plan, if required under § 46.1122 (relating to HACCP plans).
(7) Other information that may be required by the Department or licensor for the proper review of the proposed construction, conversion or modification of a food facility, and requested by the Department or licensor in writing.
§ 46.1122. HACCP plans.
(a) When an HACCP plan is required.
(1) Before engaging in an activity that requires an HACCP plan, a food facility applicant or food facility operator shall submit to the Department or licensor for approval a properly prepared HACCP plan as specified in subsection (b) and the relevant provisions of this chapter if any of the following occurs:
(i) Submission of an HACCP plan is required according to applicable Federal or State laws.
(ii) A variance is required as specified in § 46.250(b)(2)(ii), § 46.361(d)(2), § 46.401 or § 46.589(b).
(iii) The Department or licensor determines that a food preparation or processing method requires a variance based on a plan submittal specified in § 46.1121(b) (relating to facility and operating plans), an inspectional finding or a variance request.
(2) A food facility applicant or food facility operator shall have a properly prepared HACCP plan as specified in § 46.402 (relating to reduced oxygen packaging).
(b) Contents of an HACCP plan. For a food facility that is required in subsection (a) to have an HACCP plan, the plan and specifications shall indicate the following:
(1) A categorization of the types of potentially hazardous foods that are specified in the menu such as soups and sauces, salads, and bulk, solid foods such as meat roasts, or of other foods that are specified by the Department or licensor.
(2) A flow diagram by specific food or category type identifying critical control points and providing information on the following:
(i) Ingredients, materials and equipment used in the preparation of that food.
(ii) Formulations or recipes that delineate methods and procedural control measures that address the food safety concerns involved.
(3) Food employee and supervisory training plan that addresses the food safety issues of concern.
(4) A statement of standard operating procedures for the plan under consideration including clearly identifying the following:
(i) Each critical control point.
(ii) The critical limits for each critical control point.
(iii) The method and frequency for monitoring and controlling each critical control point by the food employee designated by the person in charge.
(iv) The method and frequency for the person in charge to routinely verify that the food employee is following standard operating procedures and monitoring critical control points.
(v) Action to be taken by the person in charge if the critical limits for each critical control point are not met.
(vi) Records to be maintained by the person in charge to demonstrate that the HACCP plan is properly operated and managed.
(5) Additional scientific data or other information, as required by the Department or licensor, supporting the determination that food safety is not compromised by the proposal.
§ 46.1123. Confidentiality of trade secrets.
The Department will treat as confidential information that meets the criteria specified in law for a trade secret and is contained on inspection report forms and in the plans and specifications submitted as specified in §§ 46.1121(b) and 46.1122(b) (relating to facility and operating plans; and HACCP plans).
§ 46.1124. Preoperational inspection of construction.
The Department or licensor will conduct one or more preoperational inspections to verify that the food facility is constructed and equipped in accordance with the approved plans and approved modifications of those plans, and variances granted under § 46.1103 (relating to variances). The Department or licensor will also verify the food facility is otherwise in compliance with this chapter, the Food Act and the Public Eating and Drinking Places Law.
REQUIREMENTS FOR OPERATION § 46.1141. Requirement: license or registration.
(a) General requirement. A person may not operate a food facility without a valid registration issued by the Department, or license issued by the Department or licensor, unless otherwise provided in subsection (b).
(b) Exceptions.
(1) A building, structure or place owned, leased or otherwise in possession of a person or municipal corporation or public or private organization, used or intended to be used by two or more farmers or an association of farmers for the purpose of selling food directly to consumers--otherwise known as a farmer's market--shall be considered to be a single retail food establishment for purposes of registration under section 14 of the Food Act (31 P. S. § 20.3).
(2) The following food establishments are exempt from registration requirements under section 14 of the Food Act:
(i) Vehicles used primarily for the transportation of a consumer commodity in bulk or quantity to manufacturers, packers, processors or wholesale or retail distributors.
(ii) A food establishment in which at least 50% of the commodities sold were produced on the farm on which the food establishment is located.
(iii) A food establishment in which food or beverages are sold only through a vending machine.
(iv) A food establishment in which only prepackaged, nonpotentially hazardous food or beverages are sold.
§ 46.1142. Application procedure for appropriate license or registration.
Prior to the opening of a food facility, the operator shall contact the Department or licensor to obtain the appropriate application form for the required license or registration. The Department or licensor will supply the applicant the appropriate form, based upon the type of food facility involved. If the food facility is a public eating and drinking place, the applicant shall obtain a license. If the food facility is a retail food establishment, the applicant must obtain a registration. A single location (such as a grocery store that also serves hot ready-to-eat foods) might require both a license and a registration.
§ 46.1143. Issuance.
(a) New, converted or remodeled food facilities. For food facilities that are required to submit plans as specified in § 46.1121(a) (relating to facility and operating plans), the Department will issue a registration, or the Department or licensor will issue a license to the applicant after the following occur:
(1) The required plans, specifications and information are reviewed and approved.
(2) A preoperational inspection, as described in § 46.1124 (relating to preoperational inspection of construction) shows that the facility is built or remodeled in accordance with the approved plans and specifications and that the facility is in compliance with this chapter.
(3) A properly completed application is submitted.
(4) The required fee is submitted.
(b) License or registration renewal. The food facility operator of an existing food facility shall submit an application, the required fee and be in compliance with this chapter prior to issuance by the Department of a renewed registration or license, or the issuance of a renewed license by the Department or a licensor.
(c) Change of ownership. Licenses and registrations are nontransferable. New owners shall apply to the Department or licensor in accordance with § 46.1142 (relating to application procedure for appropriate license or registration).
§ 46.1144. Conditions of retention: responsibilities of the food facility operator.
To retain a license or registration issued by the Department or licensor under this chapter, a food facility operator shall do the following:
(1) Post the license or registration in a location in the food facility that is conspicuous to consumers and the Department or licensor.
(2) Comply with this chapter--including the conditions of a granted variance as specified in § 46.1103(c) (relating to variances)--and approved plans as specified in § 46.1121(b) (relating to facility and operating plans).
(3) If a food facility is required in § 46.1122(a) (relating to HACCP plans) to operate under an HACCP plan, comply with the plan as specified in § 46.1103(c).
(4) Immediately contact the Department or licensor to report an illness of a food employee as specified in § 46.111(b) (relating to duty to report disease or medical condition).
(5) Immediately discontinue operations and notify the Department or licensor if an imminent health hazard may exist because of an emergency such as a fire, flood, extended interruption of electrical or water service, sewage backup, misuse of poisonous or toxic materials, onset of an apparent foodborne illness outbreak, gross unsanitary occurrence or condition or other circumstance that may endanger public health. A food facility operator need not discontinue operations in an area of a facility that is unaffected by the imminent health hazard.
(6) Not resume operations discontinued in accordance with paragraph (5) or otherwise according to the Public Eating and Drinking Places Law or the Food Act until approval is obtained from the Department or licensor.
(7) Allow representatives of the Department or licensor access to the food facility as specified in § 46.1101 (relating to access to food facilities).
(8) Except as specified in paragraph (9), replace existing facilities and equipment with facilities and equipment that comply with this chapter if either of the following occurs:
(i) The Department or licensor directs the replacement because the facilities and equipment constitute a public health hazard or no longer comply with the criteria upon which the facilities and equipment were accepted.
(ii) The facilities and equipment are replaced in the normal course of operation.
(9) Upgrade or replace refrigeration equipment as specified in § 46.385(a)(3) (relating to potentially hazardous food: hot and cold holding), by December 13, 2008, if the circumstances specified in paragraph (8)(i) and (ii) do not occur first, and unless a variance has been approved as specified in § 46.1103.
(10) Comply with directives of the Department or licensor including time frames for corrective actions specified in inspection reports, notices, orders, warnings and other directives issued by the Department or licensor in regard to the operator's food facility or in response to community emergencies.
(11) Accept notices issued and served by the Department or licensor according to the Public Eating and Drinking Places Law or the Food Act.
CHAPTER 47. (Reserved) §§ 47.1--47.3. (Reserved).
Subpart B. LIQUID FOODS
CHAPTER 53. (Reserved) §§ 53.1--53.7. (Reserved).
§§ 53.11--53.19. (Reserved).
§ 53.21. (Reserved).
§ 53.22. (Reserved).
CHAPTER 55. (Reserved) §§ 55.1--55.5. (Reserved).
CHAPTER 61. (Reserved) §§ 61.1--61.7. (Reserved).
§§ 61.11--61.13. (Reserved).
§ 61.21. (Reserved).
§ 61.22. (Reserved).
§§ 61.31--61.34. (Reserved).
§§ 61.41--61.43. (Reserved).
§§ 61.51--61.53. (Reserved).
§§ 61.61--61.65. (Reserved).
§ 61.71. (Reserved).
§ 61.72. (Reserved).
CHAPTER 63. (Reserved) §§ 63.1--63.4. (Reserved).
Subpart C. MISCELLANEOUS PROVISIONS
CHAPTER 78. (Reserved) §§ 78.1--78.3. (Reserved).
§§ 78.11--78.14. (Reserved).
§§ 78.21--78.24. (Reserved).
§ 78.31. (Reserved).
§ 78.32. (Reserved).
§§ 78.41--78.43. (Reserved).
§§ 78.51--78.53. (Reserved).
§§ 78.61--78.65. (Reserved).
§§ 78.71--78.78. (Reserved).
§§ 78.91--78.97. (Reserved).
§ 78.101. (Reserved).
§ 78.111--78.114. (Reserved).
§ 78.121. (Reserved).
§ 78.122. (Reserved).
§ 78.131--78.133. (Reserved).
§ 78.141--78.147. (Reserved).
§ 78.151--78.155. (Reserved).
§ 78.161. (Reserved).
§ 78.171--78.173. (Reserved).
§ 78.181. (Reserved).
§ 78.191. (Reserved).
§ 78.192. (Reserved).
§ 78.201--78.204. (Reserved).
§ 78.211. (Reserved).
§ 78.212. (Reserved).
§ 78.221. (Reserved).
CHAPTER 79. (Reserved) § 79.1. (Reserved).
CHAPTER 80. (Reserved) § 80.1. (Reserved).
§§ 80.11--80.13. (Reserved).
§§ 80.21--80.23. (Reserved).
§ 80.31. (Reserved).
§ 80.32. (Reserved).
§§ 80.41--80.48. (Reserved).
§ 80.51. (Reserved).
§ 80.52. (Reserved).
§§ 80.61--80.63. (Reserved).
§ 80.71. (Reserved).
§ 80.72. (Reserved).
§§ 80.81--80.84. (Reserved).
CHAPTER 81. (Reserved) § 81.1. (Reserved).
§ 81.11. (Reserved).
§ 81.12. (Reserved).
§ 81.21. (Reserved).
[Pa.B. Doc. No. 03-2381. Filed for public inspection December 12, 2003, 9:00 a.m.]
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