Subchapter C. FOOD

§ 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 system as specified in 21 CFR 120 (relating to hazard analysis and critical control point HACCP systems) and be one of the following:

   (1)  Obtained pasteurized or otherwise treated to attain a 5-log reduction (a 99.999% reduction) of the most resistant microorganism of public health significance as specified in 21 CFR 120.24 (relating to process controls).

   (2)  Bear a warning label as specified in 21 CFR 101.17(g) (relating to food labeling warning, notice, and safe handling statements).

PREVENTING CONTAMINATION BY EMPLOYEES

§ 46.261. Preventing contamination from food employees’ hands.

 (a)  Hand washing required. Food employees shall wash their hands as specified in §  46.131 (relating to cleanliness of hands and exposed portions of arms).

 (b)  Hand contact with ready-to-eat food. Except when washing fruits and vegetables as specified in §  46.285 (relating to washing raw fruits and vegetables) or when approved in accordance with subsection (d), food employees may not contact exposed, ready-to-eat food with their bare hands, and shall use suitable utensils such as deli tissue, spatulas, tongs, single-use gloves or dispensing equipment.

 (c)  Hand contact with food that is not ready-to-eat food. Food employees shall minimize bare hand and arm contact with exposed food that is not in a ready-to-eat form.

 (d)  Approval of bare-hand contact. Food employees may contact ready-to-eat foods with their bare hands if the food facility operator submits a written plan to the Department and the Department provides the food facility operator written approval of the plan. The written plan and related documentation, and the Department’s written approval shall be available at the food facility for use by the person in charge and review by the Department upon request. The written plan shall contain the following:

   (1)  The reason the person-in-charge of the food facility is unable to comply with subsection (b).

   (2)  A provision identifying the public health hazards associated with bare-hand contact specific to the food facility, demonstrating that these hazards are understood by the food facility operator.

   (3)  Verification that the food facility has implemented and is in compliance with all applicable supervision, employee health, personal cleanliness and hygienic practices provisions required under Subchapter B (relating to management and personnel).

   (4)  A provision identifying exposed ready-to-eat foods that will be contacted with bare hands and the procedures and practices which are in place to assure that food employees wash their hands before returning to their work station and that cross-contamination from touching raw foods and ready-to-eat foods is precluded.

   (5)  An effective training plan for food employees.

     (i)   The plan shall emphasize the following subjects addressed in this chapter:

       (A)   Not working when ill.

       (B)   Good hygienic practices and personal cleanliness.

       (C)   Proper handwashing procedures.

       (D)   Safe food preparation procedures.

     (ii)   The training plan shall acknowledge management responsibility for training, specify the program content and training frequency (including refresher training).

   (6)  Documentation demonstrating that paragraph (5)(i) and (ii) are implemented, and are verified by management.

   (7)  An action plan identifying corrective actions to be taken in situations in which the practices and procedures in the written plan are not complied with.

 A food employee may not use a utensil more than once to taste food that is to be sold or served.

PREVENTING FOOD AND INGREDIENT CONTAMINATION

§ 46.281. Preventing contamination of packaged and unpackaged food: separation, packaging and segregation.

 (a)  Required protective measures. Food shall be protected from cross contamination by the following procedures, as applicable:

   (1)  Separating raw animal-derived foods during storage, preparation, holding and display from:

     (i)   Raw ready-to-eat food including other raw animal-derived food such as fish for sushi or molluscan shellfish, or other raw ready-to-eat food such as vegetables.

     (ii)   Cooked ready-to-eat food.

   (2)  Separating types of raw animal-derived foods (such as beef, fish, lamb, pork and poultry) from each other during storage, preparation, holding and display, except when these raw animal-derived foods are combined as ingredients, by doing the following:

     (i)   Using separate equipment for each type or arranging each type of food in equipment so that cross contamination of one type with another is prevented.

     (ii)   Preparing each type of food at different times or in separate areas.

   (3)  Cleaning equipment and utensils as specified in §  46.712(a) (relating to frequency of cleaning equipment food-contact surfaces and utensils) and sanitizing as specified in §  46.731(c) (relating to sanitization: requirement, frequency and methods).

   (4)  Storing the food in packages, covered containers or wrappings. The exception to this requirement is in subsection (b).

   (5)  Cleaning hermetically sealed containers of food of visible soil before opening.

   (6)  Protecting food containers that are received packaged together in a case or overwrap from cuts when the case or overwrap is opened.

   (7)  Storing damaged, spoiled or recalled food being held in the food facility as specified in §  46.964 (relating to distressed merchandise: segregated).

   (8)  Separating fruits and vegetables from ready-to-eat food before the fruits and vegetables are washed as specified in §  46.285 (relating to washing raw fruits and vegetables).

 (b)  Exception to the requirement of storing foods in packages, covered containers or wrappings. Subsection (a)(4) does not apply to the following:

   (1)  Whole, uncut, raw fruits and vegetables and nuts in the shell that require peeling or hulling before consumption.

   (2)  Primal cuts, quarters or sides of raw meat or slab bacon that are hung on clean, sanitized hooks or placed on clean, sanitized racks.

   (3)  Whole, uncut, processed meats such as country hams and smoked or cured sausages that are placed on clean, sanitized racks.

   (4)  Food being cooled as specified in §  46.384(d)(2) (relating to potentially hazardous food: cooling).

 Pasteurized eggs or egg products shall be substituted for raw shell eggs in the preparation of foods such as Caesar salad, hollandaise or b[eacute]arnaise sauce, mayonnaise, eggnog, ice cream and egg-fortified beverages that are not either of the following:

   (1)  Cooked as specified in §  46.361(a)(1) or (2) (relating to cooking raw animal-derived foods).

 (a)  Unapproved additives or unsafe levels of approved additives. Food or food ingredients shall be protected from contamination that may result from the addition of unsafe or unapproved food or color additives, and from unsafe or unapproved levels of approved food and color additives, as described in §  46.242 (relating to additives).

 (b)  Sulfiting agents. A food employee may not do the following:

   (1)  Apply sulfiting agents to fresh fruits and vegetables intended for raw consumption or to a food considered to be a good source of vitamin B1, as that term is defined in 21 CFR 101.54(c) (relating to nutrient content claims for “good source,” “high,” “more,” and “high potency”).

 (a)  General. Raw fruits and vegetables shall be thoroughly washed in water to remove soil and other contaminants before being cut, combined with other ingredients, cooked, served or offered for human consumption in ready-to-eat form.

 (b)  Exception. Whole, raw fruits and vegetables which are intended for washing by the consumer before consumption need not be washed before they are sold.

 (c)  Chemical washing. Fruits and vegetables may be washed by using chemicals as specified in §  46.1024(b) (relating to chemicals: use criteria).

 (a)  Ice used as exterior coolant is prohibited as ingredient. Ice may not be used as food after it has been used as a medium for cooling the exterior surfaces of food such as melons or fish, packaged foods such as canned beverages or cooling coils and tubes of equipment.

 (b)  Storage or display of food in contact with water or ice.

   (1)  Packaged food. Packaged food may not be stored in direct contact with ice or water if the food is subject to the entry of water because of the nature of its packaging, wrapping or container or its positioning in the ice or water.

   (2)  General prohibition. Unpackaged foods other than those described in paragraphs (3) and (4) may not be stored in direct contact with undrained ice.

   (3)  Certain raw fruits and vegetables. Whole, raw fruits or vegetables; cut, raw vegetables such as celery or carrot sticks or cut potatoes; and tofu may be immersed in ice or water.

   (4)  Raw chicken and raw fish. Raw chicken and raw fish that are received immersed in ice in shipping containers may remain in that condition while in storage awaiting preparation, display, service or sale.

PREVENTING CONTAMINATION FROM EQUIPMENT, UTENSILS AND LINENS

§ 46.301. Preventing contamination from food contact with equipment and utensils.

 (a)  General. During pauses in food preparation or dispensing, food preparation and dispensing utensils shall be stored in the food with their handles above the top of the food and the container, unless the food is non-potentially hazardous and within containers or equipment that can be closed, such as bins of sugar, flour or cinnamon—in which case the food preparation and dispensing utensils shall be stored with their handles above the top of the food within the containers.

 (b)  Storage on cleaned and sanitized tables or equipment. During pauses in food preparation or dispensing, food preparation and dispensing utensils may be stored on a clean portion of the food preparation table or cooking equipment only if the in-use utensil and the table or equipment are cleaned and sanitized at a frequency specified in § §  46.712 and 46.731 (relating to frequency of cleaning equipment food-contact surfaces and utensils; and sanitization: requirement, frequency and methods).

 (c)  Storage in running water. During pauses in food preparation or dispensing, food preparation and dispensing utensils may be stored in running water of sufficient velocity to flush particulates to the drain, if used with moist food such as ice cream or mashed potatoes.

 (d)  Storage in clean, protected locations. During pauses in food preparation or dispensing, food preparation and dispensing utensils may be stored in a clean, protected location if the utensils, such as scoops, are used only with a food that is not potentially hazardous.

 Linens and napkins may not be used in contact with food unless they are used for either of the following purposes:

   (1)  To line a container for the service of foods, where the linens and napkins are replaced each time the container is refilled for a new consumer.

   (2)  For retail display of nonpotentially hazardous food, where the linens and napkins are replaced with each restocking of the retail display.

 (a)  Cloths used for wiping food spills. Cloths that are used for wiping food spills shall be used for no other purpose.

 (b)  Wet and dry wiping cloths. Cloths used for wiping food spills shall be one of the following:

   (1)  Dry and used for wiping food spills from tableware and carry-out containers.

   (2)  Wet and cleaned as specified in §  46.751(b)(4) (relating to requirement and frequency of laundering), stored in a chemical sanitizer at a concentration specified in §  46.674(a) (relating to warewashing equipment: mechanical or manual), and used for wiping spills from food-contact and nonfood-contact surfaces of equipment.

 (c)  Wiping cloths used with raw animal-derived foods. Dry or wet cloths that are used with raw animal-derived foods shall be kept separate from cloths used for other purposes, and wet cloths used with raw animal-derived foods shall be kept in a separate sanitizing solution.

 (a)  Single-use gloves. Single-use gloves shall be used for only one task (such as working with ready-to-eat food or with raw animal-derived food), used for no other purpose and discarded when damaged or soiled, or when interruptions occur in the operation.

 (b)  Slash-resistant gloves: general. Except as specified in subsection (c), slash-resistant gloves that are used to protect the hands during operations requiring cutting shall be used in direct contact only with food that is subsequently cooked as specified in § §  46.361—46.366 (relating to destruction of organisms of public health concern), such as frozen food or a primal cut of meat.

 (c)  Slash-resistant gloves: exception. Slash-resistant gloves may be used with ready-to-eat food that will not be subsequently cooked if the slash-resistant gloves have a smooth, durable and nonabsorbent outer surface; or if the slash-resistant gloves are covered with a smooth, durable, nonabsorbent glove or a single-use glove.

 (d)  Cloth gloves. Cloth gloves may not be used in direct contact with food unless the food is subsequently cooked as required in § §  46.361—46.366, such as frozen food or a primal cut of meat.

 (a)  General. A food employee may not use tableware, including single-service articles, soiled by the consumer, to provide second portions or refills. However, a food employee may refill a consumer’s drinking cup or container without contact between the pouring utensil and the lip-contact area of the drinking cup or container.

 (b)  Use of soiled tableware by self-service consumers to obtain food from display or serving equipment prohibited. Self-service consumers may not be allowed to use soiled tableware (including single-service articles) to obtain additional food from the display and serving equipment. The sole exception to this prohibition is described in subsection (c).

 (c)  Use of soiled drinking cups by self-service consumers to obtain drinks. Drinking cups and containers may be reused by self-service consumers if refilling is a contamination-free process as specified in §  46.583(1), (2) and (4) (relating to dispensing equipment: protection of equipment and food).

 (a)  Refilling with potentially hazardous food prohibited. A take-home food container returned to a food facility may not be refilled at a food facility with a potentially hazardous food.

 (b)  Refilling with a cleaned container. Except as specified in subsection (c), a take-home food container refilled with food that is not potentially hazardous shall be cleaned as specified in §  46.719(b) (relating to washing returnable containers for refilling).

 (c)  Refilling certain containers by a contamination-free process. Personal take-out beverage containers, such as thermally insulated bottles, nonspill coffee cups and promotional beverage glasses, may be refilled by employees or the consumer if refilling is a contamination-free process as specified in §  46.583(1)—(3) (relating to dispensing equipment: protection of equipment and food).

   This section cited in 7 Pa. Code §  46.719 (relating to washing returnable containers for refilling).

PREVENTING CONTAMINATION FROM THE PREMISES

§ 46.321. Food storage.

 (a)  General storage requirements. Except as specified in subsections (b) and (c), food shall be protected from contamination by storing as follows:

   (1)  In a clean, dry location.

   (2)  Where it is not exposed to splash, dust or other contamination.

   (3)  At least 15 cm (6 inches) above the floor.

 (b)  Exception for food stored on case lot handling equipment. Food in packages and working containers may be stored less than 15 cm (6 inches) above the floor on case lot handling equipment as specified in §  46.595 (relating to case lot handling equipment: moveability).

 (c)  Exception for particular food containers. Pressurized beverage containers, cased food in waterproof containers such as bottles or cans, and milk containers in plastic crates may be stored on a floor that is clean and not exposed to floor moisture.

 (d)  Foods storage: prohibited areas. Food may not be stored in any of the following locations:

   (1)  A locker room.

   (2)  A toilet room.

   (3)  A dressing room.

   (4)  A garbage room.

   (5)  A mechanical room.

   (6)  Under a sewer line that is not shielded to intercept potential drips.

   (7)  Under a leaking water line (including a leaking automatic fire sprinkler head), or under a line on which water has condensed.

   (8)  Under an open stairwell.

   (9)  Under any other source of contamination, such as peeling paint, unprotected light bulbs, some ventilation units or outside sheds.

 During preparation, unpackaged food shall be protected from environmental sources of contamination, such as outside dust, construction or renovation debris, or ventilation dust.

PREVENTING CONTAMINATION BY CONSUMERS

§ 46.341. Food display.

 (a)  General. Condiments shall be protected from contamination by being kept in dispensers that are designed to provide protection, protected food displays provided with the proper utensils, original containers designed for dispensing, or individual packages or portions.

 (a)  Raw, unpackaged animal-derived foods. Raw, unpackaged animal-derived food (such as beef, lamb, pork, poultry and fish) may not be offered for consumer self-service. This subsection does not apply to consumer self-service of ready-to-eat foods at buffets or salad bars that serve foods such as sushi or raw shellfish; ready-to-cook individual portions for immediate cooking and consumption on the premises such as consumer-cooked meats or consumer-selected ingredients for Mongolian barbecue; or raw, frozen, shell-on shrimp or lobster.

 (b)  Ready-to-eat foods. Consumer self-service operations for ready-to-eat foods shall be provided with suitable utensils or effective dispensing methods that protect the food from contamination.

 (a)  General prohibition of reuse of returned or unused food. Except as specified in subsection (b), after being served or sold and in the possession of a consumer, food that is unused or returned by the consumer may not be offered as food for human consumption.

 (b)  Exception for certain foods and packages. A container of food that is not potentially hazardous may be transferred from one consumer to another if either of the following occurs:

   (1)  The food is dispensed so that it is protected from contamination and the container is closed between uses, such as a narrow-neck bottle containing catsup, steak sauce or wine.

   (2)  The food, such as crackers, salt or pepper, is in an unopened original package and is maintained in sound condition.

DESTRUCTION OF ORGANISMS OF PUBLIC HEALTH CONCERN

§ 46.361. Cooking raw animal-derived foods.

 (a)  General cooking requirement. Except as specified in subsections (b)—(d), raw animal-derived foods (such as eggs, fish, meat, poultry and foods containing these raw animal-derived foods) shall be cooked to heat all parts of the food to a temperature and for a time that complies with one of the following methods, based on the food that is being cooked:

   (1)  63°C (145°F) or above for 15 seconds for either of the following:

     (i)   Raw shell eggs that are broken and prepared in response to a consumer’s order and for immediate service.

     (ii)   Except as specified in paragraphs (2) and (3), and subsection (b), fish, meat and pork, including game animals commercially raised for food as specified in §  46.221(a) (relating to game animals).

   (2)  68°C (155°F) for 15 seconds or the temperature specified in the following chart that corresponds to the holding time for ratites and injected meats; the following if they are comminuted: fish, meat, game animals commercially raised for food as specified in §  46.221(a); and raw eggs that are not broken and prepared in response to a consumer’s order and for immediate service:

   (3)  74°C (165°F) or above for 15 seconds for poultry, wild game animals as specified in §  46.221(b) and (c), stuffed fish, stuffed meat, stuffed pasta, stuffed poultry, stuffed ratites or stuffing containing fish, meat, poultry or ratites.

 (b)  Certain roasts. Whole beef roasts, corned beef roasts, pork roasts and cured pork roasts such as ham, shall be cooked as follows:

   (1)  In an oven that is preheated to the temperature specified for the roast’s weight in the following chart and that is held at that temperature:

   (2)  As specified in the following chart, to heat all parts of the food to a temperature and for the holding time (including postoven heat rise) that corresponds to that temperature:

 (c)  Raw or undercooked whole-muscle, intact beef steak. A raw or undercooked whole-muscle, intact beef steak may not be served or offered for sale in a ready-to-eat form unless all of the following apply:

   (1)  The food facility serves a population that is not a highly susceptible population.

   (2)  The steak is labeled to indicate that it meets the definition of “whole-muscle, intact beef” as specified in §  46.214 (relating to whole-muscle, intact beef).

   (3)  The steak is cooked on both the top and bottom to a surface temperature of 63°C (145°F) or above and a cooked color change is achieved on all external surfaces.

 (d)  Other raw animal-derived foods. A raw animal-derived food such as raw egg, raw fish, raw-marinated fish, raw molluscan shellfish, or steak tartare; or a partially cooked food such as lightly cooked fish, soft cooked eggs, or undercooked meat other than whole-muscle, intact beef steaks as specified in subsection (c), shall be served or offered for sale in a ready-to-eat form only if either of the following occurs:

   (1)  The food facility serves a population that is not a highly susceptible population, and the consumer is informed as specified in §  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 to ensure its safety, the food should be cooked as specified in subsections (a) or (b).

   (2)  The Department grants a variance from subsection (a) or (b) as specified in §  46.1103(a) (relating to variances), based on an HACCP plan that is all of the following:

     (i)   Submitted by the license holder and approved as specified in §  46.1103(b).

     (ii)   Documents scientific data or other information showing that a lesser time and temperature regimen results in a safe food.

     (iii)   Verifies that equipment and procedures for food preparation and training of food employees at the food facility meet the conditions of the variance.

 Raw animal-derived foods cooked in a microwave oven shall meet all of the following conditions:

   (1)  Rotated or stirred throughout or midway during cooking to compensate for uneven distribution of heat.

   (2)  Covered to retain surface moisture.

   (3)  Heated to a temperature of at least 74°C (165°F) in all parts of the food.

   (4)  Allowed to stand covered for 2 minutes after cooking to obtain temperature equilibrium.

 Fruits and vegetables that are cooked for hot holding shall be cooked to a temperature of 58°C (135°F).

 (a)  General temperature requirement. Except as specified in subsection (b), before service or sale in ready-to-eat form, raw, raw-marinated, partially cooked or marinated-partially cooked fish other than molluscan shellfish shall be frozen throughout to a temperature of one of the following:

   (1)  -20°C (-4°F) or below for 168 hours (7 days) in a freezer.

   (2)  -35°C (-31°F) or below for 15 hours in a blast freezer.

 (b)  Exception for certain tuna species. If the fish are tuna of the species Thunnus alalunga, Thunnus albacares (Yellowfin tuna), Thunnus atlanticus, Thunnus maccoyii (Bluefin tuna, Southern), Thunnus obesus (Bigeye tuna), or Thunnus thynnus (Bluefin tuna, Northern), the fish may be served or sold in a raw, raw-marinated or partially cooked ready-to-eat form without freezing as specified in subsection (a).

 (c)  Records: creation and retention.

   (1)  Except as specified in subsection (b) and paragraph (2), if raw, raw-marinated, partially cooked or marinated-partially cooked fish are served or sold in ready-to-eat form, the person in charge shall record the freezing temperature and time to which the fish are subjected and shall retain the records at the food facility for 90-calendar days beyond the time of service or sale of the fish.

   (2)  If the fish are frozen by a supplier, a written agreement or statement from the supplier stipulating that the fish supplied are frozen to a temperature and for a time specified in subsection (a) may substitute for the records specified in paragraph (1).

 (a)  Preparation for immediate service. Cooked and refrigerated food that is prepared for immediate service in response to an individual consumer order, such as a roast beef sandwich au jus, may be served at any temperature.

 (b)  Reheating for hot holding.

   (1)  Potentially hazardous food that is cooked, cooled and reheated for hot holding shall be reheated so that all parts of the food reach a temperature of at least 74°C (165°F) for 15 seconds. Reheating for hot holding shall be done rapidly and the time the food is between the temperature specified in §  46.385(a)(2) or (3) (relating to potentially hazardous food: hot and cold holding) and 74°C (165°F) may not exceed 2 hours. Exceptions to these requirements are specified in paragraphs (2)—(4).

   (2)  Except as specified in paragraph (3), reheating of potentially hazardous food in a microwave oven for hot holding shall be performed in accordance with §  46.362 (relating to microwave cooking).

   (3)  Ready-to-eat food taken from a commercially processed, hermetically sealed container or from an intact package from a food establishment that is inspected by the Department or other food regulatory agency that has jurisdiction over the food processing plant shall be heated to a temperature of at least 58°C (135°F) for hot holding.

   (4)  Remaining unsliced portions of roasts that are cooked as specified in §  46.361(b) (relating to cooking raw animal-derived foods) shall be reheated for hot holding using the oven parameters and minimum time and temperature conditions specified in §  46.361(b).

 Juice packaged in a food facility shall be one of the following:

   (1)  Treated under an HACCP plan (as described in §  46.1122(b) (relating to HACCP plans)) to attain a 5-log reduction (a 99.999% reduction) of the most resistant microorganism of public health significance.

   (2)  If not treated to yield a 5-log reduction of the most resistant microorganism of public health concern, labeled as specified §  46.422 (relating to labeling) and as specified in 21 CFR 101.17(g) (relating to food labeling warning, notice, and safe handling statements) with the following:

  Warning: This product has not been pasteurized and, therefore, may contain harmful bacteria that can cause serious illness in children, the elderly, and persons with weakened immune systems.

   This section cited in 7 Pa. Code §  46.305 (relating to gloves: use limitations).

TEMPERATURE AND TIME CONTROL FOR LIMITATION OF GROWTH OF ORGANISMS OF PUBLIC HEALTH CONCERN

§ 46.381. Stored frozen food.

 Frozen potentially hazardous food that is slacked to moderate the temperature shall be held at one of the following:

   (1)  Under refrigeration that maintains the food temperature at 5°C (41°F) or less, or at 7°C (45°F) or less as specified in §  46.385(a)(3) (relating to potentially hazardous food: hot and cold holding).

 Except as specified in paragraph (4), potentially hazardous food shall be thawed by one of the procedures that follow:

   (1)  Under refrigeration that maintains the food temperature at 5°C (41°F) or less, or at 7°C (45°F) or less as specified in §  46.385(a)(3) (relating to potentially hazardous food: hot and cold holding).

   (2)  Completely submerged under running water at a water temperature of 21°C (70°F) or below; with sufficient water velocity to agitate and float off loose particles in an overflow, for one of the following:

     (i)   A period of time that does not allow thawed portions of ready-to-eat food to rise above 5°C (41°F), or 7°C (45°F) as specified in §  46.385(a)(3).

     (ii)   A period of time that does not allow thawed portions of a raw animal-derived food requiring cooking as specified in §  46.361(a) or (b) (relating to cooking raw animal-derived foods) to be above 5°C (41°F), or 7°C (45°F) as specified in §  46.385(a)(3) for more than 4 hours including both of the following:

       (A)   The time the food is exposed to the running water and the time needed for preparation for cooking.

       (B)   The time it takes under refrigeration to lower the food temperature to 5°C (41°F), or 7°C (45°F) as specified in §  46.385(a)(3).

   (3)  As part of a cooking process if the food that is frozen is one of the following:

     (i)   Cooked as specified in §  46.361(a) or (b) or §  46.362 (relating to microwave cooking).

     (ii)   Thawed in a microwave oven and immediately transferred to conventional cooking equipment, with no interruption in the process.

 (a)  Cooling cooked potentially hazardous food. Cooked potentially hazardous food shall be cooled as follows:

   (1)  Within 2 hours, from 58°C (135°F) to 21°C (70°F).

   (2)  Within 6 hours, from 58°C (135°F) to 5°C (41°F) or less, or to 7°C (45°F) as specified in §  46.385(a)(3) (relating to potentially hazardous food: hot and cold holding).

 (b)  Cooling potentially hazardous food prepared from ingredients at ambient temperature. Potentially hazardous food shall be cooled within 4 hours to 5°C (41°F) or less, or to 7°C (45°F) as specified in §  46.385(a)(3) if prepared from ingredients at ambient temperature, such as reconstituted foods and canned tuna.

 (c)  Cooling methods. Cooling shall be accomplished in accordance with the time and temperature criteria specified in subsection (a) by using one or more of the following methods, based on the type of food being cooled:

   (1)  Placing the food in shallow pans.

   (2)  Separating the food into smaller or thinner portions.

   (3)  Using rapid cooling equipment.

   (4)  Stirring the food in a container placed in an ice water bath.

   (5)  Using containers that facilitate heat transfer.

   (6)  Adding ice as an ingredient.

   (7)  Other effective methods.

 (d)  Food containers in which food is cooled. When placed in cooling or cold holding equipment, food containers in which food is being cooled shall be both of the following:

   (1)  Arranged in the equipment to provide maximum heat transfer through the container walls.

   (2)  Loosely covered, or uncovered if protected from overhead contamination as specified in §  46.321(a)(2) (relating to food storage), during the cooling period to facilitate heat transfer from the surface of the food.

 (a)  General. Except during preparation, cooking or cooling, or when time is used as the public health control as specified in subsection (c), potentially hazardous food shall be maintained at one of the following temperatures, as applicable:

   (1)  At 58°C (135°F) or above, except that roasts cooked to a temperature and for a time specified in §  46.361(b) (relating to cooking raw animal-derived foods) or reheated as specified in §  46.365(b)(5) (relating to reheating food) may be held at a temperature of 54°C (130°F) or above.

   (2)  At 5°C (41°F) or less except as specified in paragraphs (3)—(5), or §  46.584(b) (relating to vending machines).

   (3)  At 7°C (45°F) or between 7°C (45°F) and 5°C (41°F) in existing refrigeration equipment that is not capable of maintaining the food at 5°C (41°F) or less if either of the following is accurate:

     (i)   The equipment is in place and in use in the food facility; and by December 13, 2008, the equipment is upgraded or replaced so that it shall maintain food at a temperature of 5°C (41°F) or less.

     (ii)   A food facility operator can demonstrate to the Department that a hardship would result from meeting the requirements of this paragraph and a variance is applied for and granted by the Department. The variance will not relieve the applicant from meeting the food safety objectives of this chapter.

   (4)  At 7°C (45°F) or less for shell eggs, or as otherwise specified in section 3 of the Egg Refrigeration Law (31 P. S. §  300.3).

   (5)  At 7°C (45°F) or less for milk products, for a maximum period allowed by the ‘‘sell-by’’ coding required by §  59.22 (relating to milk dating), or as otherwise specified in the Milk Sanitation Law.

 (b)  Date marking of ready-to-eat, potentially hazardous food.

   (1)  Except as specified in paragraph (4) or (5), refrigerated, ready-to-eat, potentially hazardous food prepared and held in a food facility for more than 48 hours shall be clearly marked to indicate either of the following:

     (i)   The date by which the food shall be consumed on the premises, sold or discarded.

     (ii)   The date on which the food was prepared.

   (2)  Refrigerated ready-to-eat potentially hazardous food prepared and packaged by a food processing plant shall be clearly marked with the date the original container is opened in a food facility. Except as specified in paragraphs (4) and (5), all food repackaged from the original container by the food facility shall be clearly marked to indicate the date by which the food shall be consumed on the premises, sold or discarded, and in no case may this date be beyond the manufacturer’s use-by date.

   (3)  A refrigerated, ready-to-eat, potentially hazardous food that is frequently rewrapped (such as lunchmeat or a roast), or for which date marking is impractical (such as soft serve mix or milk in a dispensing machine), shall be marked as in paragraph (1) or (2), or by an alternative method acceptable to the Department.

   (4)  Paragraphs (1) and (2) do not apply to individual meal portions served or repackaged for sale from a bulk container upon a consumer’s request.

   (5)  Paragraph (2) does not apply to the following:

     (i)   Fermented sausages produced in a Federally inspected food processing plant that are not labeled ‘‘keep refrigerated’’ and which retain the original casing on the product.

     (ii)   Shelf stable, dry fermented sausages.

     (iii)   Shelf stable salt-cured products such as prosciutto and parma (ham) produced in a Federally inspected food processing plant that are not labeled ‘‘keep refrigerated’’—provided that when the face is cut, the remaining portion is whole and intact.

   (6)  A refrigerated, ready-to-eat, potentially hazardous food ingredient or a portion of a refrigerated, ready-to-eat, potentially hazardous food is subsequently combined with additional ingredients or portions of food, shall retain the date marking of the earliest-prepared or first-prepared ingredient.

 (c)  Time as a public health control.

   (1)  Except as specified in paragraph (2), if time—rather than temperature—is used as the public health control for a working supply of potentially hazardous food before cooking, or for ready-to-eat potentially hazardous food that is displayed or held for service for immediate consumption, all of the following shall be done:

     (i)   The food shall be marked or otherwise identified to indicate the time that is 4 hours past the point in time when the food is removed from temperature control.

     (ii)   The food shall be cooked and served, served if ready-to-eat, or discarded, within 4 hours from the point in time when the food is removed from temperature control.

     (iii)   The food in unmarked containers or packages or marked to exceed a 4-hour limit shall be discarded.

     (iv)   Written procedures shall be maintained in the food facility and made available to the Department upon request, that ensure compliance with this subsection and §  46.384(a)—(b) (relating to potentially hazardous food: cooling) for food that is prepared, cooked and refrigerated before time is used as a public health control.

   (2)  In a food facility that serves a highly susceptible population, time only—rather than temperature—may not be used as the public health control for raw eggs.

   This section cited in 7 Pa. Code §  46.365 (relating to reheating food); 7 Pa. Code §  46.382 (relating to potentially hazardous food: slacking); 7 Pa. Code §  46.383 (relating to potentially hazardous food: thawing); 7 Pa. Code §  46.384 (relating to potentially hazardous food: cooling); 7 Pa. Code §  46.441 (relating to discarding or reconditioning unsafe, adulterated or contaminated); 7 Pa. Code §  46.584 (relating to vending machines); and 7 Pa. Code §  46.1114 (relating to conditions of retention: responsibilities of the food facility operator).

SPECIALIZED PROCESSING METHODS

§ 46.401. Variance requirement for specialized processing methods.

 A food facility shall obtain a variance from the Department as specified in §  46.1103(a) and (b) (relating to variances) before using any specialized processing method not currently recognized by the Department as a safe method for processing food.

 (a)  General requirement. A food facility that packages food using a reduced oxygen packaging method—where Clostridium botulinum is identified as a microbiological hazard in the final packaged form of the food—shall ensure that there are at least two barriers in place to control the growth and toxin formation of Clostridium botulinum. This requirement does not apply to a food facility that has obtained a variance under §  46.401 (relating to variance requirement for specialized processing methods).

 (b)  HACCP plan requirement. A food facility that packages food using a reduced oxygen packaging method—where Clostridium botulinum is identified as a microbiological hazard in the final packaged form of the food—shall have an HACCP plan that contains the information specified in §  46.1122(b)(4) (relating to HACCP plans) and that does all of the following:

   (1)  Identifies the food to be packaged.

   (2)  Limits the food packaged to a food that does not support the growth of Clostridium botulinum because it complies with one of the following:

     (i)   Has an a_w of 0.91 or less.

     (ii)   Has a pH of 4.6 or less.

     (iii)   Is a meat or poultry product cured at a food establishment regulated by USDA using substances specified in 9 CFR 424.21 (relating to use of food ingredients and sources of radiation), and is received in an intact package.

     (iv)   Is a food with a high level of competing organisms such as raw meat or raw poultry.

   (3)  Specifies methods for maintaining food at 5°C (41°F) or below.

   (4)  Describes how the packages shall be prominently and conspicuously labeled on the principal display panel in bold type on a contrasting background, with instructions to do the following:

     (i)   Maintain the food at 5°C (41°F) or below.

     (ii)   For food held at refrigeration temperatures, discard the food within 14 calendar days of its packaging if it is not served for on-premises consumption, or it is not consumed if served or sold for off-premises consumption.

   (5)  Limits the refrigerated shelf life to no more than 14 calendar days from packaging to consumption or the original manufacturer’s “sell by” or “use by” date, whichever occurs first.

   (6)  Includes operational procedures that do all of the following:

     (i)   Prohibit contacting food with bare hands.

     (ii)   Identify a designated area and the method by which physical barriers or methods of separation of raw foods and ready-to-eat foods minimize cross contamination, and access to the processing equipment is limited to responsible trained personnel familiar with the potential hazards of the operation.

     (iii)   Cleaning and sanitization procedures for food-contact surfaces are delineated.

   (7)  Describes the training program that ensures that the individual responsible for the reduced oxygen packaging operation understands concepts required for a safe operation, the equipment and facilities, and the procedures specified in paragraph (6) and §  46.1122(b)(4).

 (c)  Special limitation with respect to certain fish. Except for fish that is frozen before, during and after packaging, a food facility may not package fish using a reduced oxygen packaging method.

   This section cited in 7 Pa. Code §  46.1122 (relating to HACCP plans).

FOOD IDENTITY, PRESENTATION AND ON-PREMISES LABELING

§ 46.421. Accurate representation.

 (a)  Standards of identity. Packaged food shall comply with standard of identity requirements in the following:

   (1)  Sections 9 and 13(f) of the Food Act (31 P. S. § §  20.9 and 20.13(f)).

   (2)  Definitions in 21 CFR Parts 131—169 and 9 CFR 319 (relating to definitions and standards of identity or composition).

   (3)  21 CFR Part 130 (relating to food standards: general).

   (4)  9 CFR Part 319, Subpart A (relating to general).

 (b)  Food shall be honestly presented.

   (1)  Food shall be offered for human consumption in a way that does not mislead or misinform the consumer.

   (2)  Food or color additives, colored overwraps or lights may not be used to misrepresent the true appearance, color or quality of a food.

 (a)  Labels required on packaged foods. Food packaged in a food facility shall be labeled as specified in sections 9, 10 and 13(f) of the Food Act (31 P. S. § §  20.9, 20.10 and 20.13(f)), 21 CFR Part 101 (relating to food labeling), 9 CFR 317 (relating to labeling, marking devices, and containers) and 9 CFR part 381, Subpart N (relating to labeling and containers).

 (b)  Label information on packaged foods. Label information on packaged foods shall include the following:

   (1)  The common name of the food, or absent a common name, an adequately descriptive identity statement.

   (2)  If made from two or more ingredients, a list of ingredients in descending order of predominance by weight, including a declaration of artificial color or flavor and chemical preservatives, if contained in the food.

   (3)  An accurate declaration of the quantity of contents.

   (4)  The name and place of business of the manufacturer, packer or distributor.

   (5)  Except as exempted in section 403(q)(3)—(5) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.A. §  343(q)(3)—(5)), nutritional labeling as specified in 21 CFR Part 101 (relating to food labeling) and 9 CFR Part 317, Subpart B (relating to nutrition labeling).

   (6)  Disclosure of the use of canthaxanthin for any salmonid fish containing canthaxanthin as a color additive, by the labeling of the bulk fish container, including a list of ingredients, displayed on the retail container or by other written means, such as a counter card.

 (c)  Labeling information on bulk foods available for consumer self-dispensing or on unpackaged foods portioned to consumer specifications. Bulk food that is available for consumer self-dispensing or unpackaged foods portioned to consumer specifications shall be prominently labeled with one of the following in plain view of the consumer:

   (1)  The manufacturer’s or processor’s label that was provided with the food.

   (2)  A card, sign or other method of notification (such as a product labeling book) that includes the information specified in subsection (b)(1), (2) and (5).

 (d)  Labeling information on certain bakery products. Bakery products need not be labeled if they are sold directly to the consumer and the following are accurate:

   (1)  The food is either manufactured or prepared on the premises of the food facility or at another food facility that is owned by the same person and is regulated by the Department or other food regulatory agency that has jurisdiction.

   (2)  The information specified in subsection (b)(1), (2) and (5) is available at the place of sale.

   (3)  A health, nutrient content or other claim is not made.

 (e)  Concealed or altered labeling information. Food facility or manufacturers’ dating information on foods may not be concealed or altered.

 Except as specified in § §  46.361(c) and (d)(3) and 46.461 (relating to cooking raw animal-derived foods; and additional safeguards for a food facility that serves a highly susceptible population), if an animal-derived food such as beef, eggs, fish, lamb, milk, pork, poultry or shellfish that is raw, undercooked or not otherwise processed to eliminate pathogens is offered in a ready-to-eat form as a deli, menu, vended or other item; or as a raw ingredient in another ready-to-eat food, the food facility shall inform consumers by brochures, deli case or menu advisories, label statements, table tents, placards or other effective written means of the significantly increased risk associated with certain highly susceptible populations eating these foods in raw or undercooked form.

   This section cited in 7 Pa. Code §  46.3 (relating to definitions); 7 Pa. Code §  46.102 (relating to duties of the person in charge); 7 Pa. Code §  46.361 (relating to cooking raw animal-derived foods); and 7 Pa. Code §  46.1121 (relating to facility and operating plans).

UNSAFE, ADULTERATED OR CONTAMINATED FOOD

§ 46.441. Discarding or reconditioning unsafe, adulterated or contaminated food.

 The following foods shall be discarded:

   (1)  A food that is unsafe, adulterated or not honestly presented as specified in §  46.201 (relating to food shall be safe, unadulterated and honestly presented), unless the food is reconditioned according to a procedure approved by the Department.

   (2)  Food that is not from an approved source as specified in § §  46.211—46.221.

   (3)  Ready-to-eat food that may have been contaminated by an employee that has been restricted or excluded as specified in §  46.113 (relating to duty to impose exclusions and restrictions).

   (4)  Food that is contaminated by food employees, consumers or other persons through contact with their hands, bodily discharges, such as nasal or oral discharges, or other means.

   (5)  A food specified in §  46.385(b)(1) and (2) (relating to potentially hazardous food: hot and cold holding), if any of the following occur:

     (i)   The food exceeds the temperature specified in §  46.385(a) for more than 4 hours or for an undetermined amount of time.

     (ii)   The food is in a container or package that does not bear a date or day.

   (6)  Refrigerated, ready-to-eat, potentially hazardous food prepared in a food facility and dispensed through a vending machine with an automatic shutoff control shall be discarded if it exceeds a temperature as specified in §  46.385(a).

SPECIAL REQUIREMENTS FOR HIGHLY SUSCEPTIBLE POPULATIONS

§ 46.461. Additional safeguards for a food facility that serves a highly susceptible population.

 (a)  Prepackaged juice bearing a warning label prohibited. In a food facility that serves a highly susceptible population, prepackaged juice or a prepackaged beverage containing juice that bears a warning label as specified in 21 CFR 101.17(g) (relating to food labeling warning, notice, and safe handling statements), may not be served or offered for sale.

 (b)  Unpackaged juice prepared on the premises. In a food facility that serves a highly susceptible population, unpackaged juice that is prepared on the premises for service or sale in a ready-to-eat form shall be processed under an HACCP plan that contains the information specified in §  46.1122 (relating to HACCP plans) and as specified in 21 CFR 120.24 (relating to process controls).

 (c)  Pasteurized eggs required in certain foods. In a food facility that serves a highly susceptible population, pasteurized shell eggs or pasteurized liquid, frozen or dry eggs or egg products shall be substituted for raw shell eggs in the preparation of the following:

   (1)  Foods such as Caesar salad, hollandaise or B[eacute]arnaise sauce, mayonnaise, egg nog, ice cream and egg-fortified beverages.

   (2)  Except as specified in subsection (e), recipes in which more than one egg is broken and the eggs are combined.

 (d)  Prohibited ready-to-eat foods. In a food facility that serves a highly susceptible population, the following foods may not be served or offered for sale in a ready-to-eat form:

   (1)  Raw animal-derived foods such as raw fish, raw-marinated fish, raw molluscan shellfish and steak tartare.

   (2)  A partially cooked animal-derived food such as lightly cooked fish, rare meat, soft-cooked eggs that are made from raw shell eggs and meringue.

   (3)  Raw seed sprouts.

 (e)  Limited exception allowing use of raw eggs. In a food facility that serves a highly susceptible population, subsection (c)(2) does not apply in any of the following circumstances:

   (1)  The raw eggs are combined immediately before cooking for one consumer’s serving at a single meal, cooked as specified in §  46.361(a)(1) (relating to cooking raw animal-derived foods), and served immediately, such as an omelet, souffl[eacute] or scrambled eggs.

   (2)  The raw eggs are combined as an ingredient immediately before baking and the eggs are thoroughly cooked to a ready-to-eat form, such as a cake, muffin or bread.

   (3)  The preparation of the food is conducted under an HACCP plan that accomplishes the following:

     (i)   Identifies the food to be prepared.

     (ii)   Prohibits contacting ready-to-eat food with bare hands.

     (iii)   Includes specifications and practices that ensure the following:

       (A)   Salmonella Enteritidis growth is controlled before and after cooking.

       (B)   Salmonella Enteritidis is destroyed by cooking the eggs according to the temperature and time specified in §  46.361(a)(2).

     (iv)   Contains the information specified in §  46.1122(b)(4) including procedures that accomplish the following:

       (A)   Control cross contamination of ready-to-eat food with raw eggs.

       (B)   Delineate cleaning and sanitization procedures for food-contact surfaces.

     (v)   Describes the training program that ensures that the food employee responsible for the preparation of the food understands the procedures to be used.

   This section cited in 7 Pa. Code §  46.423 (relating to consumer advisory required with respect to animal-derived foods that are raw, undercooked or not otherwise processed to eliminate pathogens).