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[32 Pa.B. 1046]

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§ 46.219.  Molluscan shellfish.

   (a)  Sources. Molluscan shellfish shall be obtained from sources according to the act and this chapter, 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.

§ 46.220.  Wild mushrooms.

   (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 an approved 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 establishment that is regulated by the Department or other food regulatory agency that has jurisdiction over the food establishment.

§ 46.221.  Game animals.

   (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 established in 9 CFR 352 (relating to exotic animals; voluntary inspection) or rabbits that are ''inspected and certified'' in accordance with the Rabbit Inspection Program established 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 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 regulatory agency that has animal health jurisdiction.

   (ii)  Requirements which are developed by the Department or other 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 be received for sale or service if 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 regulatory agency that has animal health jurisdiction.

   (ii)  Requirements which are developed by the Department or other 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 be received for sale or service 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).

§ 46.222.  Ice.

   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 foods; microwave cooking; and plant food cooking for hot holding) and received hot shall be at an internal temperature of 60°C (140°F) or above.

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

   (d)  Visible evidence of improper temperature. Upon receipt, potentially hazardous food shall be free of evidence of previous temperature abuse.

§ 46.242.  Additives.

   Food may not contain unapproved food additives or additives that exceed amounts specified in 21 CFR 170--180 (relating to food additives), generally recognized as safe or prior sanctioned substances that exceed amounts specified in 21 CFR 181--186 (relating to food substances generally recognized as safe), substances that exceed amounts specified in 9 CFR 318.7 (Reserved), or pesticide residues that exceed provisions specified in 40 CFR 185 (Reserved).

§ 46.243.  Receiving shell eggs.

   (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 Chapter 87 (relating to standards for grading and marketing eggs).

   (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 the Egg Refrigeration Law (31 P. S. §§ 300.1--300.9).

   (c)  Labeling. Shell eggs received by a food facility shall be labeled as specified in Chapter 87 and include safe handling instructions as specified in 21 CFR 101.17(h) (relating to food labeling).

§ 46.244.  Receiving eggs and milk products.

   (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 specified in the Milk Sanitation Law

   (c)  Frozen milk products. Frozen milk products, such as ice cream, shall be obtained pasteurized as specified in 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).

§ 46.245.  Package integrity of food upon receipt.

   Food packages shall be in good condition and protect the integrity of the contents so that the food is not exposed to adulteration or potential contaminants.

§ 46.246.  Receiving shucked shellfish: packaging and identification.

   (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'' 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 act (31 P. S. § 20.6).

§ 46.247.  Shellstock identification.

   (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 act (31 P. S. § 20.6).

   (c)  Harvester's tag or label may 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.

§ 46.248.  Shellstock: condition upon receipt.

   Shellstock shall be reasonably free of mud, dead shellfish and shellfish with broken shells when received by a food facility. Dead shellfish or shellstock with badly broken shells shall be discarded.

§ 46.249.  Molluscan shellfish: original container.

   (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.

   (2)  The shellfish are protected from contamination.

§ 46.250.  Shellstock: maintaining identification.

   (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 record keeping 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)  Where shellstock are removed from their tagged or labeled container, using either of the following methods:

   (i)  Using only one tagged or labeled container at a time.

   (ii)  Using more than one tagged or labeled container at a time and obtaining a variance from the Department as specified in § 46.1103(a) (relating to variances) based on a HACCP plan that:

   (A)  Is submitted by the permitholder and approved as specified in § 46.1103(b).

   (B)  Preserves source identification by using a recordkeeping system as specified in paragraph (1).

   (C)  Ensures that shellstock from one tagged or labeled container are not commingled with shellstock from another container before being ordered by the consumer.

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 otherwise approved, food employees may not contact exposed, ready-to-eat food with their bare hands, unless hands have been washed as specified in § 46.131(b) and shall use suitable utensils such as deli tissue, spatulas, tongs, single-use gloves or dispensing equipment whenever possible.

   (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.

§ 46.262.  Preventing contamination when tasting.

   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 foods during storage, preparation, holding and display from:

   (i)  Raw ready-to-eat food including other raw animal 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 foods (such as beef, fish, lamb, pork and poultry) from each other during storage, preparation, holding and display, except when these raw animal 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).

   (5)  Shellstock.

§ 46.282.  Identification of content on food storage containers.

   Working containers holding food or food ingredients (such as cooking oils, flour, herbs, potato flakes, salt, spices and sugar) that are removed from their original packages for use in the food facility shall be identified with the common name of the food they contain. However, containers holding food that can be readily and unmistakably recognized (such as dry pasta) need not be identified.

§ 46.283.  Substituting pasteurized eggs for raw shell eggs in certain recipes.

   Pasteurized eggs or egg products shall be substituted for raw shell eggs in the preparation of foods such as Caesar salad, hollandaise or béarnaise 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 foods).

   (2)  Included in § 46.361(d).

§ 46.284.  Protection from unapproved additives.

   (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'').

   (2)  Serve or sell a food specified in paragraph (1), other than grapes, that is treated with sulfiting agents before receipt by the food facility.

§ 46.285.  Washing raw fruits and vegetables.

   (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 that 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).

§ 46.286.  Preventing contamination from ice used as a coolant.

   (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.

   Food shall only contact surfaces of equipment and utensils that are cleaned as specified in §§ 46.711--46.719 (relating to cleaning of equipment) and sanitized as specified in § 46.731 (relating to sanitization: requirement, frequency and methods).

§ 46.302.  In-use utensils and between-use storage.

   (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 ice scoops, are used only with a food that is not potentially hazardous.

   (e)  Storage in a container of water. During pauses in food preparation or dispensing, food preparation and dispensing utensils may be stored in a container of water if the water is maintained at a temperature of at least 60°C (140°F) and the container is cleaned at frequency specified in § 46.712(d)(7) (relating to frequency of cleaning equipment food-contact surfaces and utensils)

§ 46.303.  Linens and napkins: use limitations.

   Linens and napkins may not be used in contact with food unless they are used to line a container for the service of foods and the linens and napkins are replaced each time the container is refilled for a new consumer.

§ 46.304.  Wiping cloths: use limitations.

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

   (d)  General cleanliness. Wet wiping cloths used with a freshly made sanitizing solution and dry wiping cloths shall be free of food debris and visible soil.

§ 46.305.  Gloves: use limitations.

   (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 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--46.365 (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--46.365, such as frozen food or a primal cut of meat.

§ 46.306.  Using clean tableware for second portions and refills.

   (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).

§ 46.307.  Refilling returnables.

   (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, non-spill 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), (2) and (3) (relating to dispensing equipment: protection of equipment and food).

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 source of contamination.

§ 46.322.  Vended potentially hazardous food: original container.

   Potentially hazardous food dispensed through a vending machine shall be in the package in which it was placed at the food facility at which it was prepared.

§ 46.323.  Food preparation.

   During preparation, unpackaged food shall be protected from environmental sources of contamination.

PREVENTING CONTAMINATION BY CONSUMERS

§ 46.341.  Food display.

   Except for nuts in the shell and whole, raw fruits and vegetables that are intended for hulling, peeling or washing by the consumer before consumption, food on display shall be protected from contamination by the use of packaging; counter, service line or salad bar food guards; display cases; or other effective means.

§ 46.342.  Protection of condiments.

   (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.

   (b)  Condiments at a vending machine location. Condiments at a vending machine location shall be in individual packages or provided in dispensers that are filled at an approved location, such as the food facility that provides food to the vending machine location, or a properly equipped food facility that is located on the site of the vending machine location.

§ 46.343.  Consumer self-service operations.

   (a)  Raw, unpackaged animal foods. Raw, unpackaged animal 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; or 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.

   (c)  Monitoring by food employees. Consumer self-service operations such as buffets and salad bars shall be monitored by food employees trained in safe operating procedures.

§ 46.344.  Returned food and reservice of food.

   (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. Except as specified in § 46.461(c) (relating to additional safeguards for a food facility that serves a highly susceptible population), 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.

§ 46.345.  Miscellaneous sources of contamination.

   Food shall be protected from contamination that may result from a factor or source not specified in §§ 46.261, 46.262, 46.281--46.286, 46.301--46.307, 46.321--46.323 and 46.341--46.344.

DESTRUCTION OF ORGANISMS OF PUBLIC HEALTH CONCERN

§ 46.361.  Cooking raw animal foods.

   (a)  General cooking requirement. Except as specified in subsections (b)--(d), raw animal foods (such as eggs, fish, meat, poultry and foods containing these raw animal 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:

Minimum
Temperature Minimum Time
63°C (145°F) 3 Minutes
66°C (150°F) 1 Minute
70°C (158°F) Less than 1 second (instantaneous)

   (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:

Oven Type Oven Temperature for Roast Oven Temperature for Roast
Weighing less than 4.5 kg (10 lbs.) Weighing 4.5 kg (10 lbs.) or more
Still Dry 177°C (350°F) or more 121°C (250°F) or more
Convection 163°C (325°F) or more 121°C (250°F) or more
High Humidity Cooking 121°C (350°F) or more 121°C (250°F) or more

   (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:

Minimum Temperature Minimum Time
54°C (130°F) 121 Minutes
56°C (132°F) 77 Minutes
57°C (134°F) 47 Minutes
58°C (136°F) 32 Minutes
59°C (138°F) 19 Minutes
60°C (140°F) 12 Minutes
61°C (142°F)   8 Minutes
62°C (144°F)   5 Minutes
63°C (145°F)   3 Minutes

   (c)  Raw or undercooked whole-muscle, intact beef steak. A raw or undercooked whole-muscle, intact beef steak may be served or offered for sale in a ready-to-eat form if 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 foods. A raw animal 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), may be served or offered for sale in a ready-to-eat form 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 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 a HACCP plan that is all of the following:

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

   (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.

§ 46.362.  Microwave cooking.

   Raw animal foods cooked in a microwave oven 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.

§ 46.363.  Plant food cooking for hot holding.

   Fruits and vegetables that are cooked for hot holding shall be cooked to a temperature of 60°C (140°F).

§ 46.364.  Parasite destruction in fish other than molluscan shellfish by freezing.

   (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).

§ 46.365.  Reheating food.

   (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), (3) and (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 authority that has jurisdiction over the plant, shall be heated to a temperature of at least 60°C (140°F) for hot holding.

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

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