§ 46.1. Purpose.

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

   Additive—A food additive or a color additive.

   Adulterated—Food with respect to which one or more of the following is accurate:

     (i)   The food bears or contains any poisonous or deleterious substance, which may render it injurious to health. However, if the substance is not an added substance, the food will not be considered adulterated if the quantity of the substance in the food does not ordinarily render it injurious to health.

     (ii)   The food bears or contains any added poisonous or added deleterious substance, which is unsafe within the meaning of section 11 of the Food Act (31 P. S. §  20.11). This subparagraph does not apply to a pesticide chemical in or on a raw agricultural commodity, a food additive or a color additive.

     (iii)   The food is a raw agricultural commodity and bears or contains a pesticide chemical which is unsafe within the meaning of section 11 of the Food Act, except that, when a pesticide chemical has been used in or on a raw agricultural commodity with an exception granted or tolerance prescribed under section 11 of the Food Act or under any of the Federal acts and the raw agricultural commodity has been subjected to processing such as canning, cooking, freezing, dehydrating or milling, the residue of the pesticide remaining in or on the processed food will, notwithstanding section 11 of the Food Act and this subparagraph, not be deemed unsafe if the residue in or on the raw agricultural commodity has been removed to the extent possible in good manufacturing practice and the concentration of the residue in the processed food when ready to eat is not greater than the tolerance prescribed for the raw agricultural commodity.

     (iv)   The food bears or contains any food additive, which is unsafe within the meaning of section 11 of the Food Act or any of the Federal acts.

     (v)   The food consists in whole or in part of any diseased, contaminated, filthy, putrid or decomposed substance or is otherwise unfit for food.

     (vi)   The food has been produced, prepared, packed or held under unsanitary conditions so that it may have become contaminated with filth or may have been rendered diseased, unwholesome or injurious to health.

     (vii)   The food is, in whole or part, the product of a diseased animal or of an animal which has died otherwise than by slaughter.

     (viii)   The food is in a container composed, in whole or part, of any poisonous or deleterious substance which may render the contents injurious to health, unless the container is fabricated or manufactured with good manufacturing practices as that standard is defined and delineated by any of the Federal acts and their regulations.

     (ix)   The food has been intentionally subjected to radiation, unless the use of the radiation was in conformity with a regulation or exemption under section 11 of the Food Act or under one of the Federal acts.

     (x)   The food has had any valuable constituent, in whole or part, omitted or abstracted therefrom.

     (xi)   The food has had any substance substituted wholly or in part.

     (xii)   Damage or inferiority of the food is concealed in any manner.

     (xiii)   A substance has been added to the food and it is mixed or packed so as to increase its bulk or weight or reduce its quality or strength or make it appear better or of greater value than it is.

     (xiv)   The food bears or contains any color additive which is unsafe within the meaning of section 11 of the Food Act or under one of the Federal acts.

     (xv)   The food bears or contains eggs processed by or egg products derived from a manufacturing, processing or preparing method wherein whole eggs are broken using a centrifuge-type egg breaking machine that separates the egg’s liquid interior from the shell.

   Approved—Acceptable to the Department based on a determination of conformity with principles, practices and generally recognized standards proven to be scientifically sound that protect public health.

   Bed and breakfast homestead or inn—A private residence which contains ten or fewer bedrooms used for providing overnight accommodations to the public, and in which breakfast is the only meal served and is included in the charge for the room.

   Beverage—A liquid for drinking, including water.

   Bottled drinking water—Water that is sealed in bottles, packages or other containers and offered for sale for human consumption. The term includes bottled mineral water.

   CFR—The most-recently published edition or revision of the Code of Federal Regulations, a compilation of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal government.

   CIP—Cleaned in place—

     (i)    Cleaned in place by the circulation or flowing by mechanical means through a piping system of a detergent solution, water rinse and sanitizing solution onto or over equipment surfaces that require cleaning, such as the method used, in part, to clean and sanitize a frozen dessert machine.

     (ii)   The term does not include the cleaning of equipment such as band saws, slicers or mixers that are subjected to in-place manual cleaning without the use of a CIP system.

   Casing—A tubular container for sausage products made of either natural or artificial (synthetic) material.

   Certification number—A unique combination of letters and numbers assigned by the Department or other shellfish control authority having jurisdiction to a molluscan shellfish dealer according to the provisions of the National Shellfish Sanitation Program.

   Color additive—A material which is a dye, pigment or other substance made by a process of synthesis or similar artifice or extracted, isolated or otherwise derived, with or without intermediate or final change of identity, from a vegetable, animal, mineral or other source and when added or applied to a food is capable, alone or through reaction with other substances, of imparting color thereto.

     (i)   The term includes black, white and intermediate grays.

     (ii)   The term does not include materials, which the Secretary, by regulation, determines are used, or are intended to be used, solely for a purpose other than coloring.

     (iii)   The term does not include any pesticide chemical, soil or plant nutrient or other agricultural chemical solely because of its effect in aiding, retarding or otherwise affecting, directly or indirectly, the growth or otherwise natural physiological process of produce of the soil and thereby affecting its color, whether before or after harvest.

   Commingle—To combine shellstock harvested on different days or from different growing areas as identified on the tag or label or to combine shucked shellfish from containers with different container codes or different shucking dates.

   Comminuted—A food that is reduced in size by methods including chopping, flaking, grinding or mincing. The term includes fish or meat products that are reduced in size and restructured or reformulated such as gefilte fish, gyros, ground beef and sausage; and a mixture of two or more types of meat that have been reduced in size and combined, such as sausages made from two or more meats.

   Confirmed disease outbreak—A foodborne disease outbreak in which laboratory analysis of appropriate specimens identifies a causative agent and epidemiological analysis implicates the food as the source of the illness.

   Consumer—A person, who is a member of the public, takes possession of food, is not functioning in the capacity of an operator of a food facility or food processing plant, and does not offer the food for resale.

   Controlled atmosphere packaging—A type of reduced oxygen packaging in which the atmosphere of a package of food is modified so that until the package is opened, its composition is different from air, and continuous control is maintained, such as by using oxygen scavengers or a combination of total replacement of oxygen, nonrespiring food and impermeable packaging material.

   Corrosion-resistant material—A material that maintains acceptable surface cleanability characteristics under prolonged influence of the food to be contacted, the normal use of cleaning compounds and sanitizing solutions and other conditions of the use environment.

   Critical control point—A point or procedure in a specific food system where loss of control may result in an unacceptable health risk.

   Critical limit—The maximum or minimum value to which a physical, biological or chemical parameter must be controlled at a critical control point to minimize the risk that the identified food safety hazard may occur.

   Department—The Department of Agriculture of the Commonwealth.

   Drinking water, potable water or water—Safe drinking water as defined in the Pennsylvania Safe Drinking Water Act (35 P. S. § §  721.1—721.17). The term does not include water such as boiler water, mop water, rainwater, wastewater and “nondrinking” water.

   Dry storage area—A room or area designated for the storage of packaged or containerized bulk food that is not potentially hazardous and dry goods such as single service items.

   EPA—The United States Environmental Protection Agency.

   Easily cleanable—

     (i)   A characteristic of a surface that:

       (A)   Allows effective removal of soil by normal cleaning methods.

       (B)   Is dependent on the material, design, construction and installation of the surface.

       (C)   Varies with the likelihood of the surface’s role in introducing pathogenic or toxigenic agents or other contaminants into food based on the surface’s approved placement, purpose and use.

     (ii)   The term includes a tiered application of the criteria that qualify the surface as easily cleanable as specified in subparagraph (i) to different situations in which varying degrees of cleanability are required, such as one of the following:

       (A)   The appropriateness of stainless steel for a food preparation surface as opposed to the lack of need for stainless steel to be used for floors or for tables used for consumer dining.

       (B)   The need for a different degree of cleanability for a utilitarian attachment or accessory in the kitchen as opposed to a decorative attachment or accessory in the consumer dining area.

   Easily movable—A unit of equipment that is both of the following:

     (i)   Portable; mounted on casters, gliders or rollers; or provided with a mechanical means to safely tilt the unit of equipment for cleaning.

     (ii)   Has no utility connection, a utility connection that disconnects quickly or a flexible utility connection line of sufficient length to allow the equipment to be moved for cleaning of the equipment and adjacent area.

   Egg—The shell egg of the domesticated chicken, turkey, duck, goose or guinea.

   Employee—The license or registration holder, person in charge, person having supervisory or management duties, person on the payroll, family member, volunteer, person performing work under contractual agreement or other person working in a food facility.

   Equipment—

     (i)   An article that is used in the operation of a food facility such as a freezer, grinder, hood, ice maker, meat block, mixer, oven, reach-in refrigerator, scale, sink, slicer, stove, table, temperature measuring device for ambient air, vending machine or warewashing machine.

     (ii)   The term does not include items used for handling or storing large quantities of packaged foods that are received from a supplier in a cased or overwrapped lot, such as hand trucks, forklifts, dollies, pallets, racks and skids.

   Exclude—To prevent a person from working as a food employee or entering a food facility except for those areas open to the general public.

   FDA—The United States Food and Drug Administration.

 Federal acts—The Wholesome Meat Act (21 U.S.C.A. § §  601—641), the Federal Food, Drug and Cosmetic Act (21 U.S.C. § §  301—399), the Poultry Products Inspection Act (21 U.S.C.A. § §  451—471), the Fair Packaging and Labeling Act (15 U.S.C.A. § §  1451—1461), the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C.A. §  136—136y) and the Nutrition Labeling and Education Act of 1990 (21 U.S.C.A. §  343-1).

   Fish—The term includes:

     (i)   Fresh or saltwater finfish, crustaceans, all mollusks and other forms of aquatic life (including alligator, frog, aquatic turtle, jellyfish, sea cucumber, and sea urchin and the roe of those animals), other than birds or mammals, if the animal life is intended for human consumption.

     (ii)   The term includes an edible human food product derived in whole or in part from fish, including fish that have been processed in any manner.

   Food—An article used for food or drink by humans, including chewing gum and articles used for components of any article. The term does not include medicines and drugs.

   Food Act—The Food Act (31 P. S. § §  20.1—20.18).

   Food additive—

     (i)   A substance, the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food, with respect to which one or more of the following is correct:

       (A)   The substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures to be safe under the conditions of its intended use.

       (B)   The substance has been used in food prior to January 1, 1958, and is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures or experience based on common use in food, to be safe under the conditions of its intended use.

     (ii)   The term does not include the following:

       (A)   A pesticide chemical in or on a raw agricultural commodity.

       (B)   A pesticide chemical to the extent that it is intended for use or is used in the production, storage or transportation of any raw agricultural commodity.

       (C)   A color additive.

       (D)   A substance used in accordance with a sanction or approval granted prior to the enactment of this subparagraph under a statute repealed by the Food Act, under the Poultry Products Inspection Act or under the Wholesome Meat Act.

       (E)   A new animal drug.

   Foodborne disease outbreak—The occurrence of two or more cases of a similar illness after ingestion of a common food.

   Food-contact surface—One of the following:

     (i)   A surface of equipment or a utensil with which food normally comes into contact.

     (ii)   A surface of equipment or a utensil from which food may drain, drip or splash into a food, or onto a surface normally in contact with food.

   Food employee—An individual working with unpackaged food, food equipment or utensils, or food-contact surfaces.

   Food establishment—

     (i)   A retail food store and a room, building or place or portion thereof or vehicle maintained, used or operated for the purpose of commercially storing, packaging, making, cooking, mixing, processing, bottling, baking, canning, freezing, packing or otherwise preparing or transporting or handling food.

     (ii)   The term includes those portions of public eating and drinking licensees which offer food for sale for off-premises consumption, except those portions of establishments operating exclusively under milk or milk products permits.

   Food facility—A public eating or drinking place or a retail food establishment. The term does not include the following:

     (i)   A food service facility provided by or at an organized camp or campground.

     (ii)   A food service facility provided by or at a school.

     (iii)   A food service facility at an institution such as a nursing home or hospital.

     (iv)   Any other food service facility that is not a public eating or drinking place.

     (v)   Food processing plants, warehousing establishments and other food establishments that comply with the following:

       (A)   Are not retail food establishments.

       (B)   Do not provide food to the consumer either directly or indirectly (such as through the home delivery of groceries).

       (C)   Applicable Federal regulations.

   Food facility operator—The entity that is legally responsible for the operation of the food facility, such as the owner, owner’s agent or other person.

   Food facility premises—The food facility, its contents and the contiguous land or property under the control of the food facility operator. If a food facility is a component of a larger operation, such as a hotel, motel, shopping mall or public campground, and that larger operation is also under the control of the food facility operator, that larger operation is part of the food facility premises to the extent it may impact the food facility, its personnel or its operations.

   Food processing plant—A commercial operation that manufactures, packages, labels or stores food for human consumption and does not provide food directly to a consumer. The term does not include a food facility.

   Game animal—

     (i)   An animal, the products of which are food, that is not classified as any of the following:

       (A)   Fish, as that term is defined in this chapter.

       (B)   Cattle, sheep, swine, goat, horse, mule or other equine, as those terms are used in 9 CFR Chapter III, Subchapter A (relating to agency organization and terminology; mandatory meat and poultry products inspection and voluntary inspection and certification).

       (C)   Poultry, as that term is used in 9 CFR Chapter III, Subchapter A.

       (D)   Ratites, such as ostriches, emus or rheas.

     (ii)   The term includes mammals such as reindeer, elk, deer, antelope, water buffalo, bison, rabbit, squirrel, opossum, raccoon, nutria or muskrat, and nonaquatic reptiles such as land snakes.

   General use pesticide—A pesticide that is not classified by the EPA for restricted use as specified in 40 CFR 152.175 (relating to pesticides classified for restricted use).

   HACCP—Hazard Analysis Critical Control Point—A system developed by the National Advisory Committee on Microbiological Criteria for Foods that identifies and monitors specific foodborne hazards that can adversely affect the safety of the food products.

   HACCP plan—A written document that delineates the formal procedures for following the HAACP principles developed by the National Advisory Committee on Microbiological Criteria for Foods.

   Hazard—A biological, chemical or physical property (such as the presence of pathogens, pesticides, natural toxins, rodent contamination or foreign materials) that may cause an unacceptable consumer health risk.

   Hermetically sealed container—A container that is designed and intended to be secure against the entry of microorganisms and, in the case of low acid canned foods, to maintain the commercial sterility of its contents after processing.

   High humidity cooking—Cooking in an oven that attains relative humidity of greater than 90% for at least 1 hour as measured in the cooking chamber or exit of the oven, or cooking in a moisture-impermeable bag that provides 100% humidity.

   Highly susceptible population—A group of persons who are more likely than other people in the general population to experience foodborne disease because both of the following conditions exist:

     (i)   The group is comprised of immunocompromised persons, preschool-age children or older adults.

     (ii)   The group obtains food at a facility that provides services such as custodial care, health care, assisted living services, nutritional services or socialization services. Examples of facilities providing these services include child or adult day care centers, health care centers, assisted living facilities, hospitals, nursing homes, kidney dialysis centers and senior centers.

   Honestly presented—Food offered for human consumption in a way that does not mislead or misinform the consumer, and without misrepresenting the true appearance, color or quality of the food through the use of food or color additives, colored overwraps, lighting or other means.

   Imminent health hazard—A significant threat or danger to health that is considered to exist when there is evidence sufficient to show that a product, practice, circumstance or event creates a situation that requires immediate correction or cessation of operation to prevent injury based on one or more of the following:

     (i)   The number of potential injuries.

     (ii)   The nature, severity and duration of the anticipated injury.

   Injected—Manipulating a meat so that infectious or toxigenic microorganisms may be introduced from its surface to its interior through tenderizing with deep penetration or injecting the meat such as with juices which may be referred to as “injecting,” “pinning” or “stitch pumping.”

   Juice—When used in the context of food safety, the term refers to the aqueous liquid expressed or extracted from one or more fruits or vegetables, pur[eacute]es of the edible portions of one or more fruits or vegetables, or any concentrate of the liquid or pur[eacute]e. The term includes juice as a whole beverage, an ingredient of a beverage, and a puree as an ingredient of a beverage. This definition does not apply to standards of identity established by the FDA or USDA.

   Kitchenware—Food preparation and storage utensils.

   License—A grant to a licensee to operate a public eating or drinking place, as defined in the Public Eating and Drinking Places Law.

   Licensor—Includes the following:

     (i)   The county department of health or joint-county department of health, whenever the public eating or drinking place is located in a political subdivision which is under the jurisdiction of a county department of health or joint-county department of health.

     (ii)   The health authorities of cities, boroughs, incorporated towns and first-class townships, whenever the public eating or drinking place is located in a city, borough, incorporated town or first-class township not under the jurisdiction of a county department of health or joint-county department of health.

     (iii)   The health authorities of second class townships and second class townships which have adopted a home rule charter which elect to issue licenses under the Public Eating and Drinking Places Law whenever the public eating and drinking place is located in the second class township or second class township which has adopted a home rule charter not under the jurisdiction of a county department of health or joint-county department of health.

     (iv)   The Department, whenever the public eating and drinking place is located in any other area of this Commonwealth.

   Linens—Fabric items such as cloth hampers, cloth napkins, tablecloths, wiping cloths and work garments, including cloth gloves.

   mg/L—Milligrams per liter, which is the metric equivalent of parts per million.

   Meat—The flesh of animals used as food including the dressed flesh of cattle, swine, sheep or goats and other edible animals. The term does not include fish, poultry and wild game animals as specified under §  46.221(b) and (c) (relating to game animals).

   Milk Sanitation Law—The act of July 2, 1935 (P. L. 589, No. 210) (31 P. S. § §  645—660e).

   Mobile food facility—Any stationary, movable or temporary food facility—such as a stand, vehicle, cart, basket, box or similar structure from which food is stored, prepared, processed, distributed or sold—which physically locates at one site or location for no more than 14 consecutive days, whether operating continuously or not during this time. The term does not include a food facility that is physically located at one site for more than 14 consecutive days.

   Modified atmosphere packaging—

     (i)   A type of reduced oxygen packaging in which the atmosphere of a package of food is modified so that its composition is different from air but the atmosphere may change over time due to the permeability of the packaging material or the respiration of the food.

     (ii)   The term includes: reduction in the proportion of oxygen, total replacement of oxygen or an increase in the proportion of other gases such as carbon dioxide or nitrogen.

   Molluscan shellfish—An edible species of fresh or frozen oysters, clams, mussels and scallops or edible portions thereof, except when the scallop product consists only of the shucked adductor muscle.

   Nonpublic water supply—A system for the provision of piped water for human consumption that is not a public water system.

   Other food regulatory agency—Local bodies, State bodies other than the Commonwealth or Federal enforcement bodies having jurisdiction over a food establishment or food processing plant. Examples include the USDA with respect to most meat processing plants within this Commonwealth and the FDA having jurisdiction over food products imported from other countries.

   pH—The symbol for the negative logarithm of the hydrogen ion concentration, which is a measure of the degree of acidity or alkalinity of a solution. Values between 0 and 7 indicate acidity and values between 7 and 14 indicate alkalinity. The value for pure distilled water is 7, which is considered neutral.

   Packaged—

     (i)   Bottled, canned, cartoned, securely bagged or securely wrapped in a food facility or a food processing plant.

     (ii)   The term does not include a wrapper, carryout box or other nondurable container used to containerize food with the purpose of facilitating food protection during service and receipt of the food by the consumer.

   Pennsylvania Construction Code Act—35 P. S. § §  7210.101—7210.1103.

   Pennsylvania Sewage Facilities Act—35 P. S. § §  750.1—750.20a.

   Permanent food facility—A food facility—whether stationary or mobile—that is not a temporary food facility operating more than 14 days in a single calendar year—whether these days are consecutive or not.

   Person—A corporation, partnership, limited liability company, business trust, other association, government entity (other than the Commonwealth), estate, trust, foundation or natural person.

   Personal care items—

     (i)   Items or substances that may be poisonous, toxic or a source of contamination and are used to maintain or enhance a person’s health, hygiene or appearance.

     (ii)   The term includes items such as medicines, first aid supplies, cosmetics, toiletries (such as toothpaste and mouthwash) and similar items.

   Person in charge—The individual present at a food facility responsible for the operation at the time of inspection.

   Physical facilities—The structure and interior surfaces of a food facility, including accessories such as soap and towel dispensers and attachments such as light fixtures and heating or air conditioning system vents.

   Plumbing fixture—A receptacle or device that is one or more of the following:

     (i)   Permanently or temporarily connected to the water distribution system of the premises and demands a supply of water from the system.

     (ii)   Discharges used water, waste materials or sewage directly or indirectly to the drainage system of the premises.

   Plumbing system—The water supply and distribution pipes; plumbing fixtures and traps; soil, waste and vent pipes; sanitary and storm sewers and building drains, including their respective connections, devices and appurtenances within the premises; and water-treating equipment.

   Poisonous or toxic material—A substance that is not intended for ingestion and that fits within one or more of the following categories:

     (i)   Cleaners and sanitizers, including cleaning and sanitizing agents and agents such as caustics, acids, drying agents, polishes and other chemicals.

     (ii)   Pesticides.

     (iii)   Substances necessary for the operation and maintenance of the establishment, such as nonfood grade lubricants, solvents and personal care items that may be deleterious to health.

     (iv)   Substances that are not necessary for the operation and maintenance of the establishment and are on the premises for retail sale, such as petroleum products and paints.

   Potentially hazardous food—

     (i)   A food which consists, in whole or part, of milk or milk products, eggs, meat, poultry, fish, shellfish, edible crustacea or other ingredients, including synthetic ingredients, which is in a form capable of supporting rapid and progressive growth of infectious or toxigenic microorganisms.

     (ii)   The term does not include foods that have a pH level of 4.6 or below or a water activity of 0.85 or less under standard conditions or food products in hermetically sealed containers processed to maintain commercial sterility.

   Poultry—One or more of the following:

     (i)   A domesticated bird (chickens, turkeys, ducks, geese or guineas), whether live or dead, as defined in 9 CFR Chapter III, Subchapter A, Part 381 (relating to poultry products inspection regulations).

     (ii)   A migratory waterfowl or game bird, such as pheasant, partridge, quail, grouse, guineas, pigeon or squab, whether live or dead, as defined in the USDA regulations in 9 CFR Part 362 (relating to voluntary poultry inspection regulations).

     (iii)   The term does not include ratites.

   Primal cut—A basic major cut into which carcasses and sides of meat are separated, such as a beef round, pork loin, lamb flank or veal breast.

   Public eating or drinking place—A place within this Commonwealth where food or drink is served to or provided for the public, with or without charge. The term does not include dining cars operated by a railroad company in interstate commerce or a bed and breakfast homestead or inn.

   Public Eating and Drinking Places Law—The act of May 23, 1945 (P. L. 926, No. 369) (35 P. S. § §  655.1—655.13).

   Public water system—A system which provides water to the public for human consumption, and which has at least 15 service connections or regularly serves an average of at least 25 individuals daily at least 60 days out of the year, or as otherwise specified in 25 Pa. Code Chapter 109 (relating to safe drinking water).

     (i)   The term includes collection, treatment, storage and distribution facilities under control of the operator of the system and used in connection with the system.

     (ii)   The term also includes a system which provides water for bottling or bulk hauling for human consumption.

   Ratite—An animal belonging to the same family as ostriches, emus and rheas.

   Ready-to-eat food—Any of the following types of food:

     (i)   Food in a form that is edible without additional preparation to achieve food safety, such as raw animal-derived foods that have been cooked in accordance with §  46.361 or §  46.362 (relating to cooking raw animal-derived foods; and microwave cooking), or fish that have been frozen in accordance with §  46.364 (relating to parasite destruction in fish other than molluscan shellfish by freezing), although additional preparation may occur for palatability or aesthetic, epicurean, gastronomic or culinary purposes.

     (ii)   Food that is raw or partially-undercooked animal-derived food, where the food facility offering the food has complied with §  46.361(d)(1) and the consumer notification requirements of §  46.423 (relating to consumer advisory required with respect to animal-derived foods that are raw, undercooked or not otherwise processed to eliminate pathogens), although additional preparation may occur for palatability or aesthetic, epicurean, gastronomic or culinary purposes.

     (iii)   Food that is prepared in accordance with a variance issued by the Department under §  46.361(d)(2) and §  46.1103 (relating to variances), although additional preparation may occur for palatability or aesthetic, epicurean, gastronomic or culinary purposes.

     (iv)   Raw fruits and vegetables that are washed in accordance with §  46.285 (relating to washing raw fruits and vegetables).

     (v)   Fruits and vegetables that are cooked for hot holding in accordance with §  46.363 (relating to plant food cooking for hot holding).

     (vi)   Potentially hazardous food that is cooked in accordance with the time and temperature requirements for that specific food in § §  46.361—46.363, and that is cooled as specified in §  46.384 (relating to potentially hazardous food: cooling).

     (vii)   Plant food with respect to which further washing, cooking or other processing is not required for food safety, and from which rinds, peels, husks or shells (if naturally present) are removed.

   Reduced oxygen packaging—

     (i)   The reduction of the amount of oxygen in a package by removing oxygen; displacing oxygen and replacing it with another gas or combination of gases; or otherwise controlling the oxygen content to a level below that normally found in the surrounding 21% oxygen atmosphere.

     (ii)   A process as specified in subparagraph (i) that involves a food for which Clostridium botulinum is identified as a microbiological hazard in the final packaged form.

     (iii)   The term includes vacuum packaging, modified atmosphere packaging and controlled atmosphere packaging.

   Refuse—Solid waste not carried by water through the sewage system.

   Registration—A grant to a person to operate a food establishment within this Commonwealth as required by section 14 of the Food Act (31 P. S. §  20.14).

   Reg. Penna. Dept. Agr.—An abbreviation connoting that a food bearing that abbreviation on its package label has been processed by a food establishment that is “registered with the Pennsylvania Department of Agriculture” in accordance with section 14(a) of the Food Act.

   Restrict—To limit the activities of a food employee so that there is no risk of transmitting a disease that is transmissible through food and the food employee does not work with exposed food, clean equipment, utensils, linens and unwrapped single-service or single-use articles.

   Restricted egg—Any check, dirty egg, incubator reject, inedible, leaker or loss as defined in Chapter 87 (relating to standards for grading and marketing eggs).

   Restricted use pesticide—A pesticide classified for restricted use under section 3(d) of the Federal Insecticide, Fungicide and Rodenticide Act of 1947 (7 U.S.C.A. §  136(d)), or 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)).

   Retail food establishment—A food establishment which stores, prepares, packages, vends, offers for sale or otherwise provides food for human consumption and which relinquishes possession of food to a consumer directly, or indirectly, through a delivery service such as home delivery of grocery orders or delivery service provided by common carriers.

   Risk—The likelihood that an adverse health effect will occur within a population as a result of a hazard in a food.

   Safe material—One or more of the following:

     (i)   An article manufactured from or composed of materials that may not reasonably be expected to result, directly or indirectly, in their becoming a component or otherwise affecting the characteristics of any food.

     (ii)   An additive that is used as specified in section 409 or section 706 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.A. § §  301 and 376).

     (iii)   A material that is not an additive and that is used in conformity with applicable regulations of the FDA.

   Sanitization—The application of cumulative heat or chemicals on cleaned food-contact surfaces that, when evaluated for efficacy, is sufficient to yield a reduction of five logs, which is equal to a 99.999% reduction, of representative disease microorganisms of public health importance.

   Sealed—Free of cracks or other openings that allow the entry or passage of moisture.

   Secretary—The Secretary of the Department or an authorized representative, employee or agent of the Department.

   Service animal—An animal such as a guide dog, signal dog or other animal individually trained to provide assistance to an individual with a disability.

   Servicing area—An operating base location to which a mobile food facility or transportation vehicle returns regularly for things such as discharging liquid or solid wastes, refilling water tanks and ice bins and boarding food.

   Sewage—A substance, which contains waste products or excrements or other discharges from the bodies of human beings or animals and any noxious or deleterious substance being harmful or inimical to the public health, or to animal or aquatic life, or to the use of water for domestic water supply or for recreation.

   Shellfish control authority—A State, Federal, foreign, tribal or other government entity legally responsible for administering a program that includes certification of molluscan shellfish harvesters and dealers for interstate commerce.

   Shellfish permit—A permit issued by the Department in accordance with Chapter 49 (relating to shellfish) and the National Shellfish Sanitation Program, that authorizes a person to operate a food establishment for shellfish.

   Shellfish permit holder—The entity that meets the following conditions:

     (i)   Is legally responsible for the operation of the food establishment such as the owner, owner’s agent or other person.

     (ii)   Possesses a valid shellfish permit to operate a shellfish food establishment.

   Shellstock—Raw, in-shell molluscan shellfish.

   Shiga toxin-producing Escherichia coli—Any E. coli capable of producing Shiga toxins, also called Verocytotoxins or Shiga-like toxins. This includes, but is not limited to, E. coli serotypes O157:H7, O157:NM and O157:H.

   Shucked shellfish—Molluscan shellfish that have one or both shells removed.

   Single-service articles—Tableware, carry-out utensils and other items such as bags, containers, place mats, stirrers, straws, toothpicks and wrappers that are designed and constructed for one time, one person consumer use after which they are intended for discard.

   Single-use articles—

     (i)   Utensils and bulk food containers designed and constructed to be used once and discarded.

     (ii)   The term includes items such as wax paper, butcher paper, plastic wrap, formed aluminum food containers, jars, plastic tubs or buckets, bread wrappers, pickle barrels, ketchup bottles and number 10 cans which do not meet the materials, durability, strength and cleanability specifications in § §  46.521(a), 46.541(a) and 46.542(a) and (b) (relating to materials in multiuse utensils and food-contact surfaces; durability and strength; and cleanability of multiuse food-contact surfaces and CIP equipment) for multiuse utensils.

     (iii)   The term does not include formed aluminum containers used in conjunction with pan liners that may be reused to cook nonpotentially hazardous baked goods.

   Slacking—The process of moderating the temperature of a food such as allowing a food to gradually increase from a temperature of -23°C (-10°F) to -4° C (25°F) in preparation for deep-fat frying or to facilitate even heat penetration during the cooking of previously block-frozen food such as spinach.

   Smooth—One or more of the following:

     (i)   A food-contact surface having a surface free of pits and inclusions with cleanability equal to or exceeding that of (100 grit) number-3 stainless steel.

     (ii)   A nonfood-contact surface of equipment having a surface equal to that of commercial grade hot-rolled steel free of visible scale.

     (iii)   A floor, wall or ceiling having an even or level surface with no roughness or projections that renders it difficult to clean.

   Substance—A material intended for use in producing, manufacturing, packaging, processing, preparing, treating, transporting or holding food and any source of radiation intended for any use.

   Sulfiting agent—A substance which imparts a residual of sulfur dioxide.

   Table-mounted equipment—Equipment that is not portable and is designed to be mounted off the floor on a table, counter or shelf.

   Tableware—Eating, drinking and serving utensils for table use such as plates, flatware (including forks, knives and spoons) and hollowware (including bowls, cups, serving dishes and tumblers).

   Temperature measuring device—A thermometer, thermocouple, thermistor or other device that indicates the temperature of food, air or water.

   Temporary food facility—A food facility that operates for a period of no more than 14 consecutive days in a fixed location and in conjunction with a single event or celebration (such as a fair, festival, carnival or other transitory gathering).

   Temporary license—Either of the following:

     (i)   A license that is the following:

       (A)   Issued to the operator of a temporary food facility.

       (B)   Valid for the duration of a particular event or celebration (such as a fair or carnival) of no more than 14 days duration (whether these days are consecutive or nonconsecutive).

       (C)   Issued to the operator with respect to no more than three events or celebrations in a particular calendar year.

     (ii)   A license that is the following:

       (A)   Issued to a food facility operator operating a food facility, whether stationary or mobile.

       (B)   In operation for a total of no more than 14 days within a particular calendar year.

       (C)   Not in conjunction with an event or celebration.

   USDA—The United States Department of Agriculture.

   Utensil—A food-contact implement or container used in the storage, preparation, transportation, dispensing, sale or service of food. The term includes the following:

     (i)   Kitchenware or tableware that is multiuse, single-service or single-use.

     (ii)   Gloves used in contact with food.

     (iii)   The temperature sensing probes of food temperature measuring devices.

     (iv)   Probe-type price or identification tags used in contact with food.

   Utility sink—A sink used for the disposal of mop water or other similar liquid waste.

   Vacuum packaging—A type of reduced oxygen packaging in which air is removed from a package of food and the package is hermetically sealed so that a vacuum remains inside the package, such as sous vide.

   Variance—A written document issued by the Department that authorizes a modification or waiver of one or more requirements of this chapter if, in the opinion of the Department, a health hazard or nuisance will not result from the modification or waiver.

   Vending machine—A self-service device that, upon insertion of a coin, paper currency, token, card or key, dispenses unit servings of food in bulk or in packages without the necessity of replenishing the device between each vending operation.

   Vending machine location—The room, enclosure, space or area where one or more vending machines are installed and operated. The term includes the storage areas and areas on the premises that are used to service and maintain the vending machines.

   Warewashing—The cleaning and sanitizing of food-contact surfaces of equipment and utensils.

   Water activity or a_w—A measure of the free moisture in a food, obtained by dividing the water vapor pressure of the substance by the vapor pressure of pure water at the same temperature. Water activity is typically indicated by the symbol a_w.

   Water for human consumption—The term includes water that is used for drinking, bathing and showering, cooking, dishwashing or maintaining oral hygiene.

   Whole-muscle, intact beef—Whole muscle beef that is not injected, mechanically tenderized, reconstructed, or scored and marinated, from which beef steaks may be cut.

Subchapter B. MANAGEMENT AND PERSONNEL

SUPERVISION

Sec.

§ 46.101. Designation of person in charge.

 The person in charge shall perform the following duties:

   (1)  Ensure that food facility operations are not conducted in a private home where the food facility has not been approved by the Department, or in a room used as living or sleeping quarters as specified in §  46.922(k) (relating to functionality of various physical facilities of a food facility).

   (2)  Ensure that persons unnecessary to the food facility operation are not allowed in the food preparation, food storage or warewashing areas, except that brief visits and tours may be authorized by the person in charge if steps are taken to ensure that exposed food; clean equipment, utensils, linens and unwrapped single-service and single-use articles are protected from contamination.

   (3)  Ensure that employees and other persons (such as delivery and maintenance persons and pesticide applicators) entering the food preparation, food storage and warewashing areas comply with this chapter.

   (4)  Routinely monitor employee handwashing to ensure that employees effectively clean their hands.

   (5)  Routinely monitor employee observations and periodically evaluate foods upon receipt to ensure that employees visibly observe foods as they are received to determine that they are from approved sources, delivered at the required temperatures, protected from contamination, unadulterated and accurately presented.

   (6)  Conduct daily oversight of the employees’ routine monitoring of cooking temperatures using appropriate temperature measuring devices properly scaled and calibrated in accordance with § §  46.561 and 46.691(b) (relating to accuracy of temperature measuring devices for food; and utensils and temperature and pressure measuring devices: repair and calibration), to ensure the employees are properly cooking potentially hazardous food, and are being particularly careful in cooking those foods known to cause severe foodborne illness and death, such as eggs and comminuted meats.

   (7)  Conduct daily oversight of the employees’ routine monitoring of food temperatures during cooling, to ensure that employees are using proper methods to rapidly cool potentially hazardous foods that are not held hot or are not for consumption within 4 hours.

   (8)  Ensure that consumers who order raw or partially cooked ready-to-eat foods of animal origin are informed, in accordance with §  46.423 (relating to consumer advisory required with respect to animal-derived foods that are raw, undercooked or not otherwise processed to eliminate pathogens), that the food is not cooked sufficiently to ensure its safety.

   (9)  Routinely monitor solution temperature and exposure time for hot water sanitizing, and chemical concentration, pH, temperature and exposure time for chemical sanitizing, to ensure that employees properly sanitize cleaned multiuse equipment and utensils before they are reused.

   (10)  Ensure that consumers are notified that clean tableware is to be used when they return to self-service areas such as salad bars and buffets, in accordance with §  46.306 (relating to using clean tableware for second portions and refills).

   (11)  Ensure that employees prevent cross contamination of ready-to-eat food with bare hands by properly using suitable utensils, such as deli tissue, spatulas, tongs, single-use gloves or dispensing equipment, or by following a procedure approved under §  46.261(d) (relating to preventing contamination from food employees’ hands).

   (12)  Ensure that employees are properly trained in food safety as it relates to their assigned duties.

EMPLOYEE HEALTH

§ 46.111. Duty to report disease or medical condition.

 (a)  Responsibility of a food facility operator to require reporting. A food facility operator shall require a food employee and a food employee applicant to whom a conditional offer of employment is made to report to the person in charge information about their health and activities as they relate to diseases described in §  46.112 (relating to diseases or medical conditions that must be reported) or diseases that are transmissible through food.

 (b)  Responsibility of a person in charge to report information to Department. The person in charge shall notify the Department that a food employee is diagnosed with an illness due to Salmonella typhi, Shigella spp., Shiga toxin-producing Escherichia coli or hepatitis A virus.

 (c)  Responsibilities of a food employee or food employee applicant. A food employee or a person who applies for a job as a food employee shall report to the person in charge the information specified in this section in a manner that allows the person in charge to prevent the likelihood of foodborne disease transmission. This information includes the date of onset of jaundice or the date of onset of any illness or condition specified in §  46.112.

 A food employee or food employee applicant shall report the following diseases, medical conditions or special circumstances to the person in charge:

   (1)  A diagnosis of an illness due to any of the following:

     (i)   Salmonella typhi.

     (ii)   Shigella spp.

     (iii)   Shiga toxin-producing Escherichia coli.

     (iv)   Hepatitis A virus.

   (2)  A past illness from any of the following:

     (i)   Salmonella typhi within the past 3 months.

     (ii)   Shigella spp. within the past month.

     (iii)   Shiga toxin-producing Escherichia coli within the last month.

     (iv)   Hepatitis A virus.

   (3)  A symptom caused by illness, infection or other source, where that symptom is associated with an acute gastrointestinal illness such as any of the following:

     (i)   Diarrhea.

     (ii)   Fever.

     (iii)   Vomiting.

     (iv)   Jaundice.

     (v)   Sore throat with fever.

   (4)  A lesion containing pus such as a boil or infected wound that is open or draining and is any of the following:

     (i)   On the hands or wrists, unless an impermeable cover such as a finger cot or stall protects the lesion and a single-use glove is worn over the impermeable cover.

     (ii)   On exposed portions of the arms, unless the lesion is protected by an impermeable cover.

     (iii)   On other parts of the body, unless the lesion is covered by a dry, durable, tight-fitting bandage.

   (5)  The food employee or food employee applicant is suspected of causing a confirmed disease outbreak caused by S. typhi, Shigella spp., Shiga toxin-producing Escherichia coli or hepatitis A virus, including an outbreak at an event such as a family meal, church supper or festival because the food employee or applicant prepared food implicated in the outbreak.

   (6)  The food employee or food employee applicant is suspected of being exposed to a confirmed disease outbreak caused by S. typhi, Shigella spp., Shiga toxin-producing Escherichia coli or hepatitis A virus, including an outbreak at an event such as a family meal, church supper or festival because the food employee or applicant did either of the following:

     (i)   Consumed food implicated in the outbreak.

     (ii)   Consumed food at the event prepared by a person who is infected or ill with the infectious agent that caused the outbreak or who is suspected of being a shedder of the infectious agent.

   (7)  The food employee or food employee applicant lives in the same household as a person who is diagnosed with a disease caused by S. typhi, Shigella spp., Shiga toxin-producing Escherichia coli or hepatitis A virus, and knows of that diagnosis.

   (8)  The food employee or food employee applicant lives in the same household as a person who attends or works in a setting where there is a confirmed disease outbreak caused by S. typhi, Shigella spp., Shiga toxin-producing Escherichia coli or hepatitis A virus, and knows of that outbreak.

 (a)  General exclusions and restrictions. A person in charge shall impose the following exclusions and restrictions:

   (1)  Exclude a food employee from a food facility if the food employee is diagnosed with an infectious agent specified in §  46.112(1) (relating to diseases or medical conditions that must be reported).

   (2)  Restrict a food employee from working with exposed food; clean equipment, utensils, linens and unwrapped single-service and single-use articles, in a food facility if the food employee is either of the following:

     (i)   Experiencing a symptom specified in §  46.112(3) or (4).

     (ii)   Not experiencing a symptom of acute gastroenteritis specified in §  46.112(3), but has a stool that yields a specimen culture that is positive for Salmonella typhi, Shigella spp. or Shiga toxin-producing Escherichia coli.

 (b)  Special exclusions with respect to a food employee who is jaundiced. If a food employee is jaundiced, the person in charge shall exclude the food employee as a food handler until 7 days after the onset of jaundice. If a food employee is jaundiced more than 7 days after onset, the person in charge shall restrict the food employee from working with exposed food and clean equipment, utensils, linens and unwrapped single service and single use articles in a food facility.

 (c)  Special exclusions with respect to a food facility serving a highly susceptible population. If the population served by the food facility is a highly susceptible population, a person in charge shall impose any exclusions or restrictions required under subsection (a) and also exclude a food employee from the food facility if the food employee is any of the following:

   (1)  Experiencing a symptom of acute gastrointestinal illness specified in §  46.112(3) and meets any of the high-risk conditions specified in §  46.112(5), (6), (7) or (8).

   (2)  Is not experiencing a symptom of acute gastroenteritis specified in §  46.112(3), but has a stool that yields a specimen culture that is positive for S. typhi, Shigella spp. or Shiga toxin-producing Escherichia coli.

   (3)  Had a past illness from S. typhi within the last 3 months.

   (4)  Had a past illness from Shigella spp. or Shiga toxin-producing Escherichia coli within the last month.

   (5)  Jaundiced, regardless of the time of onset.

 (a)  Disease or medical condition described in §  46.112(1). A person in charge may not remove an exclusion imposed as a result of a disease or medical condition described in §  46.112(1) (relating to diseases or medical conditions that must be reported) unless the excluded person provides the person in charge written medical documentation specifying that the excluded person may work in an unrestricted capacity in a food facility, including a facility that serves a highly susceptible population, because the person is free of the infectious agent of concern. This documentation shall be from a physician licensed to practice medicine, a licensed nurse practitioner or a licensed physician assistant.

 (b)  Disease or medical condition with respect to which restrictions are imposed under §  46.113(a)(2)(i). A person in charge may not remove a restriction imposed under authority of §  46.113(a)(2)(i) (relating to duty to impose exclusions and restrictions) as a result of a disease or medical condition unless at least one of the following is accurate:

   (1)  The person is free of the symptoms specified in §  46.112(3) and (4), and no foodborne illness occurs that may have been caused by the restricted person.

   (2)  The person is suspected of causing foodborne illness, but both of the following are true:

     (i)   The person is free of the symptoms specified in §  46.112(3) and (4).

     (ii)   The person provides written medical documentation from a physician licensed to practice medicine, a licensed nurse practitioner or a licensed physician assistant stating that the restricted person is free of the infectious agent that is suspected of causing the person’s symptoms or causing foodborne illness.

   (3)  The restricted person provides written medical documentation from a physician licensed to practice medicine, a licensed nurse practitioner or a licensed physician assistant stating that the symptoms experienced result from a chronic noninfectious condition such as Crohn’s disease, irritable bowel syndrome or ulcerative colitis.

 (c)  Disease or medical condition with respect to which restrictions are imposed under authority of §  46.113(a)(2)(ii). A person in charge may not remove a restriction imposed as a result of a disease or medical condition imposed under authority of §  46.113(a)(2)(ii) unless the restricted person provides written medical documentation from a physician licensed to practice medicine, a licensed nurse practitioner or a licensed physician assistant that indicates the restricted person’s stools are free from Salmonella typhi, Shigella spp. or Shiga toxin-producing Escherichia coli—whichever is the infectious agent of concern.

 (d)  Disease or medical condition with respect to which exclusions or restrictions are imposed under authority of §  46.113(b). A person in charge may not remove an exclusion or restriction imposed as a result of a disease or medical condition described in §  46.113(b) unless the excluded or restricted person provides written medical documentation from a physician licensed to practice medicine, a licensed nurse practitioner or a licensed physician’s assistant that specifies that the person is free of hepatitis A virus.

 (e)  Disease or medical condition with respect to which exclusions are imposed under authority of §  46.113(c). A person in charge may not remove an exclusion imposed with respect to a food facility serving a highly susceptible population as a result of a disease or medical condition described in §  46.113(c) unless the restricted person provides written medical documentation from a physician licensed to practice medicine, a licensed nurse practitioner or a licensed physician’s assistant that states, as applicable, that the person is:

   (1)  Free of the infectious agent of concern.

   (2)  Free of jaundice, if hepatitis A virus is the infectious agent of concern.

   (3)  Experiencing symptoms resulting from a chronic noninfectious condition such as Crohn’s disease, irritable bowel syndrome or ulcerative colitis.

PERSONAL CLEANLINESS

§ 46.131. Cleanliness of hands and exposed portions of arms.

 (a)  Responsibility of food employees. Food employees shall keep their hands and exposed portions of their arms clean.

 (b)  Cleaning procedure.

   (1)  General procedure. Except as specified in paragraph (2), food employees shall clean their hands and exposed portions of their arms (or surrogate prosthetic devices for hands or arms) for at least 20 seconds using a cleaning compound in a handwashing sink that is equipped as specified in §  46.822(b) (relating to design, construction and installation of plumbing systems) by using the following cleaning procedure:

     (i)   Create vigorous friction on the surfaces of the lathered fingers, finger tips, areas between the fingers, hands and arms (or by vigorously rubbing the surrogate prosthetic devices for hands and arms) for at least 10—15 seconds.

     (ii)   Thoroughly rinse under clean running, warm water.

     (iii)   Immediately follow the rinse with thorough drying of cleaned hands and arms (or surrogate prosthetic devices) using a method specified in §  46.941(c) (relating to handwashing facilities: numbers and capacities).

     (iv)   Employees shall pay particular attention to the areas underneath the fingernails and between the fingers during this cleaning procedure.

   (2)  Alternative procedure. An automatic handwashing facility may be used by food employees to clean their hands if the facility is approved and capable of removing the types of soils encountered in the food operations involved.

 Food employees shall clean their hands and exposed portions of their arms as specified in §  46.131 (relating to cleanliness of hands and exposed portions of arms) as follows:

   (1)  Immediately before engaging in food preparation activities such as working with exposed food, working with clean equipment and utensils, and working with unwrapped single-service and single-use articles.

   (2)  After touching bare human body parts other than clean hands and clean, exposed portions of arms.

   (3)  After using the toilet room.

   (4)  After caring for or handling service animals or aquatic animals as specified in §  46.153(b) (relating to animals).

   (5)  Except as specified in §  46.151(a)(2) (relating to food contamination prevention), after coughing, sneezing, using a handkerchief or disposable tissue, using tobacco, eating or drinking.

   (6)  After handling soiled equipment or utensils.

   (7)  During food preparation, as often as necessary to remove soil and contamination and to prevent cross contamination when changing tasks.

   (8)  When switching between working with raw food and working with ready-to-eat food.

   (9)  Before donning gloves for working with food.

   (10)  After engaging in other activities that contaminate the hands.

 (a)  Requirements. A hand sanitizer and a chemical hand sanitizing solution used as a hand dip shall:

   (1)  Comply with one or more of the following:

     (i)   Be an approved drug that is listed in the most current FDA publication Approved Drug Products with Therapeutic Equivalence Evaluations as an approved drug based on safety and effectiveness.

     (ii)   Have active antimicrobial ingredients that are listed in the most current FDA monograph for OTC (over-the-counter) Health-Care Antiseptic Drug Products as an antiseptic handwash.

   (2)  Comply with one or more of the following:

     (i)   Have components that are exempted from the requirement of being listed in Federal food additive regulations as specified in 21 CFR 170.39 (relating to threshold of regulation for substances used in food-contact articles).

     (ii)   Comply with, and be listed in, one or more of the following:

       (A)   21 CFR 178 (relating to indirect food additives: adjuvants, production aids, and sanitizers as regulated for use as a food additive with conditions of safe use).

       (B)   21 CFR 182 (relating to substances generally recognized as safe), 21 CFR 184 (relating to direct food substances affirmed as generally recognized as safe) or 21 CFR 186 (relating to indirect food substances affirmed as generally recognized as safe).

     (iii)   Be limited to situations when use is followed by a thorough hand rinsing in clean water before hand contact with food, or when hand contact with food is avoided by the use of gloves, or where there is no direct contact with food by bare hands.

   (3)  Be applied only to hands that are cleaned as specified in §  46.131(b) (relating to cleanliness of hands and exposed portions of arms).

 (a)  General. Food employees shall keep their fingernails trimmed, filed and maintained so the edges and surfaces are cleanable and not rough.

 Food employees shall wear clean outer clothing to prevent contamination of food, equipment, utensils, linens, single-service articles and single-use articles.

HYGIENIC PRACTICES

§ 46.151. Food contamination prevention.

 (a)  Eating, drinking or using tobacco.

   (1)  General prohibition. An employee may not eat, drink or use any form of tobacco unless the use occurs in designated areas where the contamination of exposed food; clean equipment, utensils and linens; unwrapped single-service and single-use articles; or other items needing protection cannot result. The sole exception to this prohibition is in paragraph (2).

   (2)  Exception for closed beverage containers. A food employee may drink from a closed beverage container if the container is handled to prevent contamination of the following:

     (i)   The employee’s hands.

     (ii)   The container.

     (iii)   Exposed food; clean equipment, utensils and linens; and unwrapped single-service and single-use articles.

 (b)  Discharges from the eyes, nose and mouth. Food employees experiencing persistent sneezing, coughing or a runny nose that causes discharges from the eyes, nose or mouth may not work with exposed food; clean equipment, utensils and linens; or unwrapped single-service or single-use articles.

 (a)  General requirement. Employees shall wear hair restraints such as hats, hair coverings or nets, beard restraints and clothing that covers body hair, that are effectively designed and worn to keep their hair from contacting exposed food; clean equipment, utensils and linens; and unwrapped single-service and single-use articles.

 (a)  Circumstances under which handling of animals is prohibited. Food employees may not care for or handle animals that may be present such as patrol dogs, service animals or pets that are allowed as specified in §  46.982 (relating to limitations on animals).

 (b)  Circumstances under which handling of animals is permissible. Employees with service animals may handle or care for their service animals and food employees may handle or care for fish in aquariums or molluscan shellfish or crustacea in display tanks if they wash their hands as specified in § §  46.131(b) and 46.132 (relating to cleanliness of hands and exposed portions of arms; and duty of food employees to wash).

   This section cited in 7 Pa. Code §  46.132 (relating to duty of food employees to wash).

Subchapter C. FOOD

CHARACTERISTICS

Sec.

§ 46.201. Food shall be safe, unadulterated and honestly presented.

 Food shall be safe, unadulterated and—in accordance with §  46.421(b) (relating to accurate representation)—honestly presented.

   This section cited in 7 Pa. Code §  46.441 (relating to discarding or reconditioning unsafe, adulterated or contaminated food); 7 Pa. Code §  46.584 (relating to vending machines); and 7 Pa. Code §  46.632 (relating to food temperature measuring devices).

FOOD SOURCES

§ 46.211. Food sources.

 Food shall be obtained from sources that comply with the Food Act, the Public Eating and Drinking Places Law and this chapter. Records of food sources shall be maintained and made available for review upon request by the Department.

 Food prepared in a private home, not approved by the Department, may not be used or offered for human consumption in a food facility.

 Packaged food shall be labeled as specified in §  46.422 (relating to labeling).

 Whole-muscle, intact beef steaks that are intended for consumption in an undercooked form without a consumer advisory as specified in §  46.361(c) (relating to cooking raw animal-derived foods) shall be one of the following:

   (1)  Obtained from a food establishment that either packages the steaks and labels them to indicate that they meet the definition of whole-muscle, intact beef or provides an invoice or other documentation indicating that the steaks meet that definition.

   (2)  Individually cut in a food facility, and all of the following:

     (i)   Cut from whole-muscle intact beef that is labeled or documented by a food establishment to indicate that the beef meets the definition of “whole-muscle intact beef” as specified in paragraph (1).

     (ii)   Prepared so they remain intact.

     (iii)   If packaged for undercooking in a food facility, labeled or documented to indicate that they meet the definition of “whole-muscle, intact beef” as specified in paragraph (1).

 Meat and poultry that is not a ready-to-eat food and is in a packaged form when it is offered for sale or otherwise offered for consumption shall be labeled to include safe handling instructions as specified in the Food Act, including 9 CFR 317.2(i) (relating to labels: definition; required features) and 9 CFR 381.125(b) (relating to special handling label requirements).

 Food in a hermetically sealed container shall be obtained from a food establishment that is regulated by the Department or other food regulatory agency that has jurisdiction over the food processing plant.

 Milk and milk products shall be obtained from sources that comply with section 2 of the Milk Sanitation Law (31 P. S. §  646).

 (a)  Sources. Fish that are received for sale or service shall be one of the following:

   (1)  Commercially and legally caught or harvested.

   (2)  Approved for sale or service.

 (b)  Nonmolluscan fish for raw consumption. Fish, other than molluscan shellfish, that are intended for consumption in their raw form and allowed as specified in §  46.361(d)(1) (relating to cooking raw animal-derived foods) may not be offered for sale or service unless they are obtained from a supplier that freezes the fish as specified in §  46.364(a) and (b) (relating to parasite destruction in fish other than molluscan shellfish by freezing) or frozen on the premises as specified in §  46.364(a) and (b) and records are retained as specified in §  46.364(c).

 (a)  Sources. Molluscan shellfish shall be obtained from sources that are in compliance with section 14 of the Food Act (31 P. S. §  20.14), Chapter 49 (relating to shellfish) and this subchapter, and the requirements specified in the United States Department of Health and Human Services, Public Health Service, Food and Drug Administration, National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish.

 (b)  Molluscan shellfish received or intended for sale in interstate commerce. Molluscan shellfish received or intended for sale in interstate commerce shall be from sources that are listed in the Interstate Certified Shellfish Shippers List.

 (c)  Molluscan shellfish that are recreationally caught. Molluscan shellfish that are recreationally caught may not be received for sale or service.

 (a)  General source requirement. Mushroom species picked in the wild shall be obtained from sources where each mushroom is individually inspected and found to be safe by a mushroom identification expert. The exceptions to this requirement are in subsection (b).

 (b)  Exceptions. Subsection (a) does not apply to the following:

   (1)  Cultivated wild mushroom species that are grown, harvested and processed in an operation that is regulated by the Department or other food regulatory agency that has jurisdiction over the operation.

   (2)  Wild mushroom species if they are in packaged form and are the product of a food processing plant that is regulated by the Department or other food regulatory agency that has jurisdiction over the food processing plant.

 (a)  Game animals commercially raised for food. If game animals commercially raised for food are received for sale or service they shall be at least one of the following:

   (1)  Raised, slaughtered and processed under a voluntary inspection program administered by the USDA for game animals such as exotic animals (reindeer, elk, deer, antelope, water buffalo or bison) that are “inspected and approved” in accordance with the Voluntary Exotic Animal Program in 9 CFR 352 (relating to exotic animals; voluntary inspection) or rabbits that are “inspected and certified” in accordance with the Rabbit Inspection Program in 9 CFR 354 (relating to voluntary inspection of rabbits and edible products thereof).

   (2)  Under a routine inspection program conducted by the Department or other food regulatory agency that has animal health jurisdiction, and raised, slaughtered and processed according to both of the following:

     (i)   Laws governing meat and poultry, as determined by the Department or other food regulatory agency that has animal health jurisdiction.

     (ii)   Requirements which are developed by the Department or other food regulatory agency that has animal health jurisdiction, with consideration of factors such as the need for antemortem and postmortem examination by a licensed veterinarian or veterinarian’s designee.

 (b)  Wild game animals that are live-caught. Wild game animals that are live-caught may not be received for sale or service unless all of the following apply:

   (1)  The animal is under a routine inspection program conducted by the Department or other regulatory agency that has animal health jurisdiction.

   (2)  The animal is slaughtered and processed according to the following:

     (i)   Laws governing meat and poultry, as determined by the Department or other food regulatory agency that has animal health jurisdiction.

     (ii)   Requirements which are developed by the Department or other food regulatory agency that has animal health jurisdiction, with consideration of factors such as the need for antemortem and postmortem examination by a licensed veterinarian or veterinarian’s designee.

 (c)  Field-dressed wild game animals. Field-dressed wild game animals may not be received for sale or service unless under a routine inspection program that ensures that the following occur:

   (1)  The animals receive a postmortem examination by a licensed veterinarian or veterinarian’s designee.

   (2)  The animals are field-dressed and transported according to requirements specified by the Department or other regulatory agency that has animal health jurisdiction.

   (3)  The animals are processed according to laws governing meat and poultry as determined by the Department or other regulatory agency that has animal health jurisdiction.

 (d)  Endangered or threatened wildlife. A game animal may not be received for sale or service if it is a species of wildlife that is listed in 50 CFR 17 (relating to endangered and threatened wildlife and plants).

 Ice for use as a food or a cooling medium shall be made from drinking water.

SPECIFICATIONS FOR RECEIVING, ORIGINAL CONTAINERS AND RECORDS

§ 46.241. Receiving temperature of food.

 (a)  Refrigerated potentially hazardous food. Except as specified in § §  46.243(b) and 46.244(b) (relating to receiving shell eggs; and receiving eggs and milk products), refrigerated potentially hazardous food shall be at an internal temperature of 5°C (41°F) or below when received.

 (b)  Cooked potentially hazardous food. Potentially hazardous food that is cooked to a temperature and for a time specified in § §  46.361—46.363 (relating to cooking raw animal-derived foods; microwave cooking; and plant food cooking for hot holding) and received hot shall be at an internal temperature of 58°C (135°F) or above.

 (c)  Frozen food. A food that is labeled frozen and shipped frozen by a food establishment shall be received frozen.

 Food may not contain unapproved food additives or additives that exceed amounts specified in 21 CFR Part 170—Part 180 (relating to food additives), generally recognized as safe or prior-sanctioned substances that exceed amounts specified in 21 CFR Parts 181—186, substances that exceed amounts specified in 9 CFR 424.21 (relating to use of food ingredients and sources of radiation), or pesticide residues that exceed provisions specified in 40 CFR Part 180 (relating to tolerances and exemptions from tolerances for pesticide chemicals).

 (a)  General. Shell eggs shall be received clean and sound and may not exceed the restricted egg tolerances for PA Consumer Grade B as specified in §  87.41 (relating to standards).

 (b)  Temperature. Shell eggs shall be received by a food facility in refrigerated equipment that maintains an ambient temperature of 7°C (45°F) or less, or as otherwise specified in section 3 of the Egg Refrigeration Law (31 P. S. §  300.3).

 (c)  Labeling. Shell eggs received by a food facility shall be labeled as specified in § §  87.51 and 87.52 (relating to receptacles; and marketing) and include safe handling instructions as specified in 21 CFR 101.17(h) (relating to food labeling warning, notice, and safe handling statements).

 (d)  Repackaging. Cartons of shell eggs not in sound condition, such as those containing cracked eggs, leaking eggs or frozen eggs, shall be removed from retail sale. The food facility may not rework, repack or transfer shell eggs from their original cartons or containers. Shell eggs may be sold as an incomplete dozen or container provided that the quantity labeling on the carton or container is changed to reflect the actual number of shell eggs within.

 (a)  Liquid, frozen and dry eggs and egg products. Liquid, frozen and dry eggs and egg products shall be obtained pasteurized.

 (b)  Milk and milk products. Milk and milk products shall be obtained pasteurized and received at a temperature of 7°C (45°F) or less, or as otherwise permitted under the Milk Sanitation Law.

 (c)  Frozen milk products. Frozen milk products shall be obtained pasteurized or as otherwise permitted under the Milk Sanitation Law.

 (d)  Cheese. Cheese shall be obtained pasteurized unless alternative procedures to pasteurization are specified and published in the CFR. An example of acceptable alternative standards for curing certain cheese varieties is in 21 CFR 133 (relating to cheeses and related cheese products).

 (a)  Label requirement. Raw shucked shellfish shall be obtained in nonreturnable packages which bear a legible label that identifies the following:

   (1)  The name, address and certification number of the shucker-packer or repacker of the molluscan shellfish.

   (2)  For packages with a capacity of less than 1.87 L (1/2 gallon): the “sell by” or “best if used by” date.

   (3)  For packages with a capacity of 1.87 L (1/2 gallon) or more: the date shucked.

 (b)  No label or inadequate label. A package of raw shucked shellfish that does not bear a label or which bears a label which does not contain all the information as specified in subsection (a) shall be subject to a detention, in accordance with section 6 of the Food Act (31 P. S. §  20.6).

 (a)  Harvester’s and dealer’s source identification tags or labels. Shellstock shall be obtained in containers bearing legible source identification tags or labels that are affixed by the harvester and each dealer that depurates, ships or reships the shellstock, as specified in the National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish.

   (1)  Contents of harvester’s tag or label. A harvester’s tag or label shall list the following information, in the following order:

     (i)   The harvester’s identification number as described in the National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish, and that is assigned by the Department or other shellfish control authority having jurisdiction.

     (ii)   The date of harvesting.

     (iii)   The most precise identification of the harvest location or aquaculture site that is practicable based on the system of harvest area designations that is in use by the Department or other shellfish control authority having jurisdiction, and including the abbreviation of the name of the state or country in which the shellfish are harvested.

     (iv)   The type and quantity of shellfish.

     (v)   The following statement in bold, capitalized type:

  THIS TAG IS REQUIRED TO BE ATTACHED UNTIL CONTAINER IS EMPTY OR RETAGGED AND THEREAFTER KEPT ON FILE FOR 90 DAYS.

   (2)  Contents of dealer’s tag or label. A dealer’s tag or label shall list the following information, in the following order:

     (i)   The dealer’s name and address, and the certification number assigned by the Department or other shellfish control authority having jurisdiction.

     (ii)   The original shipper’s certification number including the abbreviation of the name of the state or country in which the shellfish are harvested.

     (iii)   The same information as specified for a harvester’s tag under paragraph (1)(ii)—(iv).

     (iv)   The following statement in bold, capitalized type:

  THIS TAG IS REQUIRED TO BE ATTACHED UNTIL CONTAINER IS EMPTY AND THEREAFTER KEPT ON FILE FOR 90 DAYS.

 (b)  Missing or incomplete tag or label. A container of shellstock that does not bear a tag or label or that bears a tag or label that does not contain all the information as specified in subsection (a) shall be subject to a detention, in accordance with section 6 of the Food Act (31 P. S. §  20.6).

 (c)  Harvester’s tag or label shall include dealer information. If a place is provided on the harvester’s tag or label for a dealer’s name, address and certification number, the dealer’s information shall be listed first, notwithstanding subsection (a)(1).

 (d)  Exception to requirement of separate dealer’s tag or label. If the harvester’s tag or label is designed to accommodate each dealer’s identification as specified in subsection (a)(2)(i) and (ii), individual dealer tags or labels need not be provided.

 (a)  General requirement. Molluscan shellfish may not be removed from the container in which they are received other than immediately before sale or preparation for service. The two exceptions to this requirement are set forth in subsections (b) and (c).

 (b)  Exception: shellstock. Shellstock may be removed from the container in which they are received, displayed on drained ice or held in a display container, and a quantity specified by a consumer may be removed from the display or display container and provided to the consumer if both of the following occur:

   (1)  The source of the shellstock on display is identified as specified in §  46.247 (relating to shellstock identification) and recorded as specified in §  46.250 (relating to shellstock: maintaining identification)

   (2)  The shellstock are protected from contamination.

 (c)  Exception: shucked shellfish. Shucked shellfish may be removed from the container in which they were received and held in a display container from which individual servings are dispensed upon a consumer’s request if both of the following apply:

   (1)  The labeling information for the shellfish on display as specified in §  46.246 (relating to receiving shucked shellfish: packaging and identification) is retained and correlated to the date when, or dates during which, the shellfish are sold or served.

 (a)  General requirement. Shellstock tags shall remain attached to the container in which the shellstock are received until the container is empty. The exception to this requirement is set forth in subsection (b)(2).

 (b)  Records of identification. The identity of the source of shellstock that are sold or served shall be maintained by retaining shellstock tags or labels for 90-calendar days from the date the container is emptied by the following methods:

   (1)  Using an approved recordkeeping system that keeps the tags or labels in chronological order correlated to the date when, or dates during which, the shellstock are sold or served.

   (2)  When shellstock are removed from their tagged or labeled container, preserving source identification by using a recordkeeping system as specified in paragraph (1), and ensuring that shellstock from one tagged or labeled container are not commingled with shellstock from another container before being ordered by the consumer.

 Prepackaged juice shall be obtained from a processor with an HACCP syst