HAR §11-50-2. dessert machine

The term does not include the cleaning of equipment such as band saws, slicers, or mixers that are subjected to in-place manual cleaning without the use of a CIP system. "Color additive" has the meaning stated in the Federal Food, Drug, and Cosmetic Act, section 201(t) and 21 CFR 70. 3 (f). "Commingle" means the act of combining different lots of shellfish. "Comminuted" means reduced in size by methods including chopping, flaking, grinding, or mincing. Comminuted includes fish or meat products that are reduced in size and restructured or reformulated such as gefilte fish, gyros, ground beef, and sausage; and a mixture of two or more types of meat that have been reduced in size and combined, such as sausages made from two or more meats. "Conditional employee" means a potential food employee to whom a job offer is made, conditional on responses to subsequent medical questions or examinations designed to identify potential food employees who may be suffering from a disease that can be transmitted through food and done in compliance with Title 1 of the Americans with Disabilities Act of 1990. "Confirmed disease outbreak" means a foodborne disease outbreak in which laboratory analysis of appropriate specimens identifies a causative agent and epidemiological analysis implicates the food as the source of the illness. "Consumer" means a person who is a member of the public, takes possession of food, is not functioning in the capacity of an operator of a food establishment or food processing plant, and does not offer the food for resale. "Corrosion-resistant material" means a material that maintains acceptable surface cleanability characteristics under prolonged influence of the food to be contacted, the normal use of cleaning compounds and sanitizing solutions, and other conditions of the use environment. "Counter-mounted equipment" means equipment that is not portable and is designed to be mounted off the floor on a table, counter, or shelf. "Critical control point" means a point or procedure in a specific food system where loss of control may result in an unacceptable health risk. "Critical limit" means the maximum or minimum value to which a physical, biological, or chemical parameter must be 50-6 §11-50-2 controlled at a critical control point to minimize the risk that the identified food safety hazard may occur. "Cut leafy greens" means fresh leafy greens whose leaves have been cut, shredded, sliced, chopped, or torn. The term "leafy greens" includes iceberg lettuce, romaine lettuce, leaf lettuce, butter lettuce, baby leaf lettuce (i.e., immature lettuce or leafy greens), escarole, endive, spring mix, spinach, cabbage, kale, arugula, and chard. The term "leafy greens" does not include herbs such as cilantro or parsley. "Dealer" means a person who is authorized by a shellfish control authority for the activities of shellstock shipper, shucker-packer, repacker, reshipper, or depuration processor of molluscan shellfish according to the provisions of the National Shellfish Sanitation Program. "Department" means the department of health, State of Hawaii. "Director" means the director of health of the department of health, State of Hawaii, or an authorized representative. "Disclosure" means a written statement that clearly identifies the animal-derived foods which are, or can be ordered, raw, undercooked, or without otherwise being processed to eliminate pathogens, or items that contain an ingredient that is raw, undercooked, or without otherwise being processed to eliminate pathogens. "Drinking water" means water that meets criteria as specified in 40 CFR 141, entitled "National primary drinking water regulations", and is traditionally known as "potable water". Drinking water includes the term "water" except where the term used connotes that the water is not potable, such as "boiler water", "mop water", "rainwater", "wastewater", and "nondrinking" water. "Dry storage area" means a room or area designated for the storage of packaged or containerized bulk food that is not time/temperature control for safety food and dry goods such as single-service items. "Easily cleanable" means a characteristic of a surface that: (1) Allows effective removal of soil by normal cleaning methods; (2) Is dependent on the material, design, construction, and installation of the surface; and 50-7 §11-50-2 (3) Varies with the likelihood of the surface's role in introducing pathogenic or toxigenic agents or other contaminants into food based on the surface's approved placement, purpose, and use. (4) Easily cleanable includes a tiered application of the criteria that qualify the surface as easily cleanable as specified in paragraph (1) to different situations in which varying degrees of cleanability are required such as: (A) The appropriateness of stainless steel for a food preparation surface as opposed to the lack of need for stainless steel to be used for floors or for tables used for consumer dining; or (B) The need for a different degree of cleanability for a utilitarian attachment or accessory in the kitchen as opposed to a decorative attachment or accessory in the consumer dining area. "Egg" means the shell egg of avian species such as chicken, duck, goose, guinea, quail, ratites, or turkey. Egg does not include: (1) A balut; (2) The egg of reptile species such as alligator; or ( 3) An egg product . "Egg product" means all, or a portion of, the contents found inside eggs separated from the shell and pasteurized in a food processing plant, with or without added ingredients, intended for human consumption, such as dried, frozen, or liquid eggs. The term does not include food which contains eggs only in a relatively small proportion such as cake mixes. "Employee" means the owner or operator, person in charge, food employee, person having supervisory or management duties, person on the payroll, family member, volunteer, person performing work under contractual agreement, or other person working in a food establishment. "EPA" means the U.S. Environmental Protection Agency. "Equipment" means an article that is used in the operation of a food establishment such as a freezer, grinder, hood, ice maker, meat block, mixer, oven, reach-in refrigerator, scale, sink, slicer, stove, table, temperature measuring device for ambient air, vending machine, or warewashing machine. This does not include 50-8 §11-50-2 apparatuses used for handling or storing large quantities of packaged foods that are received from a supplier in a cased or overwrapped lot, such as hand trucks, forklifts, dollies, pallets, racks, and skids. "Exclude" means to prevent a person from working as an employee in a food establishment or entering a food establishment as an employee. "FDA" means the U.S. Food and Drug Administration. "Fish" means fresh or saltwater finfish, crustaceans and other forms of aquatic life (including alligator, frog, aquatic turtle, jellyfish, sea cucumber, and sea urchin and the roe of such animals) other than birds or mammals, and all mollusks, if such animal life is intended for human consumption. Fish includes an edible human food product derived in whole or in part from fish, including fish that have been processed in any manner. "Food" means a raw, cooked, or processed edible substance, ice, beverage, or ingredient used or intended for use or for sale in whole or in part for human consumption, or chewing gum. "Food additive" has the meaning stated in the Federal Food, Drug, and Cosmetic Act, section 201(s) and 21 CFR 170.3(e)(l). "Food-contact surface" means: (1) A surface of equipment or a utensil with which food normally comes into contact; or (2) A surface of equipment or a utensil from which food may drain, drip, or splash: (A) Into a food; or (B) Onto a surface normally in contact with food. "Food employee" means an individual working with unpackaged food, food equipment or utensils, or food- contact surfaces. "Food establishment" means: (1) Any place or portion thereof, maintained, used, or operated for the purpose of storing, preparing, serving, manufacturing, packaging, transporting, or otherwise handling food for distribution at retail or wholesale to the public; and (2) Any place or portion thereof, used in support of and in conjunction with any other food establishment. "Food processing plant" means a commercial operation that manufactures, packages, labels, or stores food for 50-9 §11-50-2 human consumption, and provides food for sale or distribution to other business entities such as food processing plants or food establishments. "Game animal" means an animal, the products of which are food, that is not classified as livestock, sheep, swine, goat, horse, mule, or other equine in 9 CFR 301.2, entitled "Definitions", or as poultry, or fish. (1) Game animals includes mammals such as reindeer, elk, deer, antelope, water buffalo, bison, rabbit, squirrel, opossum, raccoon, nutria, or muskrat, and nonaquatic reptiles such as land snakes. (2) Game animal does not include ratites. "General use pesticide" means a pesticide that is not classified by EPA for restricted use as specified in 40 CFR 152.175, entitled "Pesticides classified for restricted use". "Grade A standards" means the requirements of the United States Public Health Service/FDA "Grade A Pasteurized Milk Ordinance" with which certain fluid and dry milk and milk products comply. "HACCP" means Hazard Analysis and Critical Control Point. "HACCP plan" means a written document that delineates the formal procedures for following the hazard analysis and critical control point principles developed by The National Advisory Committee on Microbiological Criteria for Foods. "Hand-pounded poi" means a product made from the process of manually pulverizing cooked taro with a stone implement on a wooden board designed for the purpose of pounding poi. "Handwashing sink" means a lavatory, a basin or vessel for washing, a wash basin, or a plumbing fixture especially placed for use in personal hygiene and designed for the washing of the hands. A handwashing sink includes an automatic handwashing facility. "Hazard" means a biological, chemical, or physical property that may cause an unacceptable consumer health risk. "Health practitioner" means a physician licensed to practice medicine, or if allowed by law, a nurse practitioner, physician assistant, or similar medical professional. "Hermetically sealed container" means a container that is designed and intended to be secure against the entry of microorganisms and, in the case of low acid canned foods, 50-10 §11-50-2 to maintain the commercial sterility of its contents after processing. "Highly susceptible population" means persons who are more likely than other people in the general population to experience foodborne disease because they are: (1) Immunocompromised; preschool age children, or older adults; and (2) Obtaining food at a facility that provides services such as custodial care, health care, or assisted living, such as a child or adult day care center, kidney dialysis center, hospital or nursing home, or nutritional or socialization services such as a senior center. "Home kitchen" means a kitchen designed and intended for use by the residents of a home. "Homemade food products" means: (1) Not time/temperature control for safety food produced or packaged in a home kitchen that does not include dried meats or seafood; and (2) Foods of plant origin that are pickled, fermented, or acidified, except for cantaloupes and other fruits from the melon family, that are produced or packaged in a home kitchen that have a pH of equal to or less than 4.2 or a Aw value that is less than 0.88; provided that any homemade food product containing cut tomatoes, such as salsa, must be kept refrigerated at or below forty-one degrees Fahrenheit. "HRS" means the Hawaii Revised Statutes. "Imminent health hazard" means a significant threat or danger to health that is considered to exist when there is evidence sufficient to show that a product, practice, circumstance, or event creates a situation that requires immediate correction or cessation of operation to prevent injury based on: (1) The number of potential injuries; and (2) The nature, severity, and duration of the anticipated injury. "Injected" means manipulating meat to which a solution has been introduced into its interior by processes that are referred to as "injecting", "pump marinating", or "stitch pumping". "In-shell product" means non-living processed shellfish with one or both shells present. "Intact meat" means a cut of whole muscle(s) meat that has not undergone comminution, mechanical tenderization, 50-11 §11-50-2 vacuum tumbling with solutions, reconstruction, cubing or pounding. "Juice" means the aqueous liquid expressed or extracted from one or more fruits or vegetables, purees of the edible portions of one or more fruits or vegetables, or any concentrates of such liquid or puree. The term does not include, for purposes of HACCP, liquids, purees, or concentrates that are not used as beverages or ingredients of beverages. "Kitchenware" means food preparation and storage utensils. "Law" means applicable local, state, and federal statutes, regulations, rules, and ordinances. "Linens" means fabric items such as cloth hampers, cloth napkins, table cloths, wiping cloths, and work garments including cloth gloves. "Major food allergen": (1) Means: (A) Milk, egg, fish (such as bass, flounder, cod, and including crustacean shellfish such as crab, lobster, or shrimp), tree nuts (such as almonds, pecans, or walnuts), wheat, peanuts, soybeans, and sesame; or (B) A food ingredient that contains protein derived from a food as specified in subparagraph (A); (2) Major food allergen does not include: (A) Any highly refined oil derived from a food specified in paragraph (1) (A) and any ingredient derived from such highly refined oil; or (B) Any ingredient that is exempt under the petition or notification process specified in the Food Allergen Labeling and Consumer Protection Act of 2004 (Public Law 108-282). "Meat" means the flesh of animals used as food including the dressed flesh of cattle, swine, sheep, or goats and other edible animals, except fish, poultry, and wild game animals as specified in section 11-50-31 (g) (1) (C) and (D). "Mechanically tenderized" means manipulating meat by piercing with a set of needles, pins, blades or any mechanical device, which breaks up muscle fiber and tough connective tissue, to increase tenderness. This includes injection, scoring, and processes which may be referred to 50-12 as "blade tenderizing", "jaccarding", "pinning", or needling". §11-50-2 "Menu change" means a modification of a food establishment's menu that would require a change in the food establishment's food preparation methods, equipment, or storage capacity previously approved by the director. These changes may include but are not limited to, the addition of time/temperature control for safety foods to a menu, installation of new food preparation or storage equipment, or increasing storage capacity. "mg/L" means milligrams per liter, which is the metric equivalent of parts per million (ppm). "Molluscan shellfish" means any edible species of fresh or frozen oysters, clams, mussels, and scallops or edible portions thereof, except when the scallop product consists only of the shucked adductor muscle. Molluscan shellfish includes shellstock, shucked shellfish, and in- shell products. "Natural disaster" means any disaster such as a tsunami, hurricane, volcanic eruption, typhoon, earthquake, or flood. "Non-continuous cooking" means the cooking of food in a food establishment using a process in which the initial heating of the food is intentionally halted so that it may be cooled and held for complete cooking at a later time prior to sale or service. The term does not include cooking procedures that only involve temporarily interrupting or slowing an otherwise continuous cooking process. "Owner" means a person who has vested rights in equity or at law in the real property or proprietary interests of the food establishment or any part of it. "Operator" means the person responsible for the overall management of the food establishment. "Packaged" means bottled, canned, cartoned, bagged, or wrapped, whether packaged in a food establishment or a food processing plant. The term does not include food wrapped or placed in a carry-out container to protect it during service or delivery to the consumer by a food employee. "Permit" means the document issued by the director that authorizes a person to operate a food establishment. "Person" means an association, a corporation, individual, partnership, other legal entity, government, or governmental subdivision or agency. 50-13 §11-50-2 "Person in charge" means the individual present at a food establishment who is responsible for the operation at the time of inspection. "Personal care items" means items or substances that may be poisonous, toxic, or a source of contamination and are used to maintain or enhance a person's health, hygiene, or appearance. Personal care items include medicines; first aid supplies; and other items such as cosmetics, and toiletries such as toothpaste and mouthwash. "pH" means the symbol for the negative logarithm of the hydrogen ion concentration, which is a measure of the degree of acidity or alkalinity of a solution. Values between zero and seven indicate acidity and values between seven and fourteen indicate alkalinity. The value for pure distilled water is seven, which is considered neutral. "Physical facilities" means the structure and interior surfaces of a food establishment including accessories such as soap and towel dispensers and attachments such as light fixtures and heating or air conditioning system vents. "Plumbing fixture" means a receptacle or device that: (1) Is permanently or temporarily connected to the water distribution system of the premises and demands a supply of water from the system; or (2) Discharges used water, waste materials, or sewage directly or indirectly to the drainage system of the premises. "Plumbing system" means the water supply and distribution pipes; plumbing fixtures and traps; soil, waste, and vent pipes; sanitary and storm sewers and building drains, including their respective connections, devices, and appurtenances within the premises; and water- treating equipment. "Poisonous or toxic materials" means substances that are not intended for ingestion and are included in four categories: (1) Cleaners and sanitizers, which include cleaning and sanitizing agents and agents such as caustics, acids, drying agents, polishes, and other chemicals; (2) Pesticides, except sanitizers, which include substances such as insecticides and rodenticides; (3) Substances necessary for the operation and maintenance of the establishment such as nonfood grade lubricants and personal care items that may be deleterious to health; and 50-14 §11-50-2 (4) Substances that are not necessary for the operation and maintenance of the establishment and are on the premises for retail sale, such as petroleum products and paints. (5) Restricted use pesticide means a pesticide product that contains the active ingredients specified in 40 CFR 152.175 Pesticides classified for restricted use, and that is limited to use by or under the direct supervision of a certified applicator. "Poultry" means: (1) Any domesticated bird (chickens, turkeys, ducks, geese, guineas, ratites, or squabs), whether live or dead, as defined in 9 CFR 381.1 Poultry products inspection regulations definitions, poultry; and (2) Any migratory waterfowl or game bird, pheasant, partridge, quail, grouse, or pigeon, whether live or dead, as defined in 9 CFR 362.1 Voluntary poultry inspection regulations, definitions. "Premises" means: (1) The physical facility, its contents, and the contiguous land or property under the control of the owner or operator; or (2) The physical facility, its contents, and the land or property not described in paragraph (1) if its facilities and contents are under the control of the owner or operator and may impact food establishment personnel, facilities, or operations, and a food establishment is only one component of a larger operation such as a health care facility, hotel, motel, school, recreational camp, or prison. "Primal cut" means a basic major cut into which carcasses and sides of meat are separated, such as a beef round, pork loin, lamb flank, or veal breast. "Public water system" has the meaning stated in 40 CFR 141, entitled "National primary drinking water regulations". "Ratite" means a flightless bird such as an emu, ostrich, or rhea. "Reduced oxygen packaging": (1) Means: (A) The reduction of the amount of oxygen in a package by removing oxygen; displacing oxygen and replacing it with another gas or 50-15 §11-50-2 combination of gases; or otherwise controlling the oxygen content to a level below that normally found in the atmosphere (approximately twenty-one per cent at sea level); and (B) A process as specified in subparagraph (A) that involves a food for which the hazards Clostridium botulinum or Listeria monocytogenes require control in the final packaged form; (2) Reduced oxygen packaging includes: (A) Vacuum packaging, in which air is removed from a package of food and the package is hermetically sealed so that a vacuum remains inside the package; (B) Modified atmosphere packaging, in which the atmosphere of a package of food is modified so that its composition is different from air but the atmosphere may change over time due to the permeability of the packaging material or the respiration of the food. Modified atmosphere packaging includes reduction in the proportion of oxygen, total replacement of oxygen, or an increase in the proportion of other gases such as carbon dioxide or nitrogen; (C) Controlled atmosphere packaging, in which the atmosphere of a package of food is modified so that until the package is opened, its composition is different from air, and continuous control of that atmosphere is maintained, such as by using oxygen scavengers or a combination of total replacement of oxygen, nonrespiring food, and impermeable packaging material; (D) Cook chill packaging, in which cooked food is hot filled into impermeable bags that are then sealed or crimped closed. The bagged food is rapidly chilled and refrigerated at temperatures that inhibit the growth of psychrotrophic pathogens; or (E) Sous vide packaging, in which raw or partially cooked food is vacuum packaged in an impermeable bag, cooked in the bag, rapidly chilled, and refrigerated at 50-16 §11-50-2 temperatures that inhibit the growth of psychrotrophic pathogens. "Refuse" means solid waste not carried by water through the sewage system. "Regulatory authority" means the local, state, or federal enforcement body or authorized representative having jurisdiction over the food establishment. "Reminder" means a written statement concerning the health risk of consuming animal foods raw, undercooked, or without otherwise being processed to eliminate pathogens. "Re-service" means the transfer of food that is unused and returned by a consumer after being served or sold and in the possession of the consumer, to another person. "Restrict" means to limit the activities of a food employee so that there is no risk of transmitting a disease that is transmissible through food and the food employee does not work with exposed food, clean equipment, utensils, linens, or unwrapped single-service or single-use articles. "Restricted egg" means any check, dirty egg, incubator reject, inedible, leaker, or loss as defined in 9 CFR 590. "Restricted use pesticide" means a pesticide product that contains the active ingredients specified in 40 CFR 152.175, entitled "Pesticides classified for restricted use" and that is limited to use by or under the direct supervision of a certified applicator. "Risk" means the likelihood that an adverse health effect will occur within a population as a result of a hazard in a food. "Safe material" means: (1) An article manufactured from or composed of materials that may not reasonably be expected to result, directly or indirectly, in their becoming a component or otherwise affecting the characteristics of any food; (2) An additive that is used as specified in section 409 of the Federal Food, Drug, and Cosmetic Act; or (3) Other materials that are not additives and that are used in conformity with applicable regulations of the Food and Drug Administration. "Sanitization" means the application of cumulative heat or chemicals on cleaned food-contact surfaces that, when evaluated for efficacy, is sufficient to yield a reduction of five logs, which is equal to a 99.999 per cent reduction, of representative disease microorganisms of public health importance. 50-17 §11-50-2 "Sealed" means free of cracks or other openings that allow the entry or passage of moisture. "Service animal" means an animal that meets the criteria as specified in 28 CFR 36, entitled "Nondiscrimination on the basis of disability in public places and commercial facilities". "Servicing area" means an operating base location to which a mobile food establishment or transportation vehicle returns regularly for such things as vehicle and equipment cleaning, discharging liquid or solid wastes, refilling water tanks and ice bins, and boarding food. "Sewage" means liquid waste containing animal or vegetable matter in suspension or solution and may include liquids containing chemicals in solution. "Shellfish control authority" means a state, federal, foreign, tribal, or other government entity legally responsible for administering a program that includes certification of molluscan shellfish harvesters and dealers for interstate commerce. "Shellstock" means live molluscan shellfish in the shell. "Shiga toxin-producing Escherichia Coli" (STEC) means any E. Coli capable of producing Shiga toxins (also called verocytotoxins). STEC infections can be asymptomatic or may result in a spectrum of illness ranging from mild non- bloody diarrhea, to hemorrhagic colitis (i.e., blood diarrhea), to hemolytic uremic syndrome (HUS - a type of kidney failure). Examples of serotypes of STEC include: E.coli O157:H7; E.coli O157:NM; E.coli O26:Hll; E.coli O145:NM; E.coli O103:H2; and E.coli O111:NM. STEC are sometimes referred to as VTEC (verocytotoxigenic E.coli) or as EHEC (Enterohemorrhagic E.coli). EHEC are a subset of STEC of which can cause hemorrhagic colitis or HUS. "Shucked shellfish" means molluscan shellfish that have both shells removed. "Single-service articles" means tableware, carry-out utensils, and other items such as bags, containers, placemats, stirrers, straws, toothpicks, and wrappers that are designed and constructed for one time, one person use after which they are intended for discard. "Single-use articles" means utensils and bulk food containers designed and constructed to be used once and discarded. Single-use articles includes items such as wax paper, butcher paper, plastic wrap, formed aluminum food containers, jars, plastic tubs or buckets, bread wrappers, pickle barrels, ke·tchup bottles, and number 10 cans which 50-18 <I §11-50-2 do not meet the materials, durability, strength, and cleanability specifications in sections 11-50-45(a) and ll-50-46(a) and (c) for multiuse utensils. "Slacking" means the process of moderating the temperature of a food such as allowing a food to gradually increase from a temperature of minus ten degrees Fahrenheit to twenty-five degrees Fahrenheit in preparation for deep- fat frying or to facilitate even heat penetration during the cooking of previously block-frozen food such as shrimp. "Smooth" means: (1) A food-contact surface having a surface free of pits and inclusions with a cleanability equal to or exceeding that of (100 grit) number 3 stainless steel; (2) A nonfood-contact surface of equipment having a surface equal to that of commercial grade hot- rolled steel free of visible scale; and (3) A floor, wall, or ceiling having an even or level surface with no roughness or projections that renders it difficult to clean. "Special event" means a planned activity where food is distributed to the public with or without charge at a single specified location held indoors or outdoors, on public or privately owned property, and may include a sporting event, carnival, fairs, farmer's markets, public exhibition, festival, religious organization function, parade or other similar gathering. "State" means the State of Hawaii. "Support kitchen" means a food establishment that provides facilities or services in support of another food establishment for cleaning, storage, food preparation, cooking, cooling, reheating, servicing water supply, or wastewater disposal. A private home kitchen shall not be used as an approved support kitchen. "Tableware" means eating, drinking, and serving utensils for table use such as flatware including forks, knives, and spoons; hollowware including bowls, cups, serving dishes, and tumblers; and plates. "Temperature measuring device" means a thermometer, thermocouple, thermistor, or other device that indicates the temperature of food, air, or water. "Time/temperature control for safety food" means a food that requires time/temperature control for safety (TCS) to limit pathogenic microorganism growth or toxin formation. 50-19 §11-50-2 (1) Time/temperature control for safety food includes: (A) An animal food that is raw or heat-treated; a plant food that is heat-treated or consists of raw seed sprouts, cut melons, cut leafy greens, cut tomatoes or mixtures of cut tomatoes that are not modified in a way so that they are unable to support pathogenic microorganism growth or toxin formation, or garlic-in-oil mixtures that are not modified in a way so that they are unable to support pathogenic microorganism growth or toxin formation; and (B) Except as specified in paragraph (2) (D), a food that because of the interaction of its Aw and pH values is designated as Product Assessment Required (PA) in Table 2-3 or Table 2-4: Table 2-3 Interaction of pH and A,. for control of spores in food heat-treated to destroy vegetative cells and subsequently packaged pH values Aw values 4.6 or less > 4.6 to 5.6 > 5.6 :-:;;o. 92 non-TCS food non-TCS food non-TCS >0.92 to 0.95 non-TCS food non-TCS food PA >0.95 non-TCS food PA PA Table 2-4 Interaction of pH and A,. for control of vegetative cells and spores in food not heat-treated or heat-treated but not packaged Aw pH values food values < 4.2 4.2 to 4.6 > 4.6 to 5.0 > 5.0 <0.88 non-TCS food non-TCS food non-TCS food non-TCS food 0.88 to non-TCS food non-TCS food non-TCS food PA 0.90 >0.90 non-TCS food non-TCS food PA PA to 0.92 >0.92 non-TCS food PA PA PA 50-20 §11-50-2 (2) Time/Temperature control for safety food does not include: (A) An air-cooled hard-boiled egg with shell intact, or an egg with shell intact that is not hard-boiled, but has been pasteurized to destroy all viable salmonellae; (B) A food in an unopened hermetically sealed container that is commercially processed to achieve and maintain commercial sterility under condition of non-refrigerated storage and distribution; (C) A food that because of its pH or Aw value, or interaction of Aw and pH values, is designated as a non-TCS food in Table 2-3 or Table 2-4; (D) A food that is designated as Product Assessment Required (PA) in Table 2-3 or Table 2-4 and has undergone a Product Assessment showing that the growth or toxin formation of pathogenic microorganisms that are reasonably likely to occur in that food is precluded due to: (i) Intrinsic factors including added or natural characteristics of the food such as preservatives, antimicrobials, humectants, acidulants, or nutrients; (ii) Extrinsic factors including environmental or operational factors that affect the food such as packaging, modified atmosphere such as reduced oxygen packaging, shelf life and use, or temperature range of storage and use; or (iii) A combination of intrinsic or extrinsic ·factors; or (E) A food that does not support the growth or toxin formation of pathogenic microorganisms in accordance with one of the paragraphs (2) (A) to (D) of this definition even though the food may contain a pathogenic microorganism or chemical or physical contaminant at a level sufficient to cause illness or injury. "Tobacco product" has the meaning stated in the Federal Food, Drug, and.Cosmetic Act §201(rr) (21 U.S.C. 321 (rr)) . 50-21