S.C. Code Regs. § § 61-25.1-201

Current through Register Vol. 48, No. 10, October 25, 2024

Section 61-25.1-201 - Applicability and Terms Defined

1-201.10Statement of Application and Listing of Terms.

(A) The following definitions shall apply in the interpretation and application of this Regulation.

(B) Terms Defined. As used in this Regulation, each of the terms listed in 1-201.10(B) shall have the meanings stated below.

(1)Accredited Program.

(a)"Accredited program" means a food protection manager certification program that has been evaluated and listed by an accrediting agency as conforming to national standards for organizations that certify individuals.

(b)"Accredited program" refers to the certification process and is a designation based upon an independent evaluation of factors such as the sponsor's mission, organizational structure, staff resources revenue sources, policies, public information regarding program scope, eligibility requirements, re-certification, discipline and grievance procedures, and test development and administration.

(c)"Accredited program" does not refer to training functions or educational programs.

(2)Additives.

(a)"Food additive" has the meaning stated in the Federal Food, Drug, and Cosmetic Act, Section 201(s) and 21 CFR 170.3(e)(1).

(b)"Color additive" has the meaning stated in the Federal Food, Drug, and Cosmetic Act, Section 201(t) and 21 CFR 70.3(f).

(3)"Adulterated" means to make food unsafe for human consumption by any means, including, but not limited to, the addition of a foreign or inferior substance or food that has violated a critical limit.

(4)"Approved" means acceptable to the Department based on a determination of conformity with principles, practices, and generally recognized standards that protect public health.

(5)"A_w" means a symbol for water activity, which measures the free moisture in a food. It is the quotient of water vapor pressure of the substance divided by the vapor pressure of pure water at the same temperature.

(6) "Balut" means an embryo inside a fertile egg that has been incubated for a period sufficient for the embryo to reach a specific stage of development after which it is removed from incubation before hatching.

(7)"Beverage" means a liquid for drinking, including water.

(8)"Boarding house" means a private residence in which lodgers rent one or more rooms for extended periods of time, usually weeks, months or years. The common parts of the house are maintained, and some services, such as laundry and cleaning, may be supplied. They normally provide "bed and board" which will include some meals as well as accommodation.

(9)"Bottled drinking water" means water that is sealed in bottles, packages, or other containers and offered for sale for human consumption, including bottled mineral water.

(10)"Casing" means a tubular container for sausage products made of either natural or artificial (synthetic) material.

(11) "Certification number" means a unique combination of letters and numbers assigned by a shellfish control authority to a molluscan shellfish dealer according to the provisions of the National Shellfish Sanitation Program.

(12)"CFR" means Code of Federal Regulations. Citations in this regulation to the CFR refer sequentially to the Title, Part, and Section numbers such as 40 CFR 180.194 refers to Title 40, Part 180, Section 194.

(13)CIP.

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

(b)"CIP" 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.

(14)"Commingle" means:

(a) To combine shellstock harvested on different days or from different growing areas as identified on the tag or label, or

(b) To combine shucked shellfish from containers with different container codes or different shucking dates.

(15)Comminuted.

(a)"Comminuted" means reduced in size by methods including chopping, flaking, grinding, or mincing.

(b)"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 (2) or more types of meat that have been reduced in size and combined.

(16)"Commissary" means a permitted retail food establishment that is authorized by the Department to provide a servicing area for mobile food unit or mobile food pushcarts for the purposes of storage of food, supplies, and single-service articles. The commissary supports the following operations:

(a) Food preparation.

(b) Equipment and utensil washing.

(c) Disposal of sewage and solid waste.

(d) Obtainment of potable water.

(e) Provides a mobile food unit or mobile food pushcart servicing and storage area.

(17)"Community-based farmers market" means a market sponsored by a community or governmental organization either having been certified by the SC Department of Agriculture as a SC Certified Farmer's Market or a farmers market that meets the definition of the Farmers Market Coalition which states, "A farmers market operates multiple times per year and is organized for the purpose of facilitating personal connections that create mutual benefits for local farmers, shoppers, and communities and implements rule or guidelines of operation that ensure that the farmers market consists principally of farms selling directly to the public products that the farms have produced."

(18)"Community festivals" means events sponsored by a community group, city/county/state organization, as a community celebration, that are generally theme related, and have multiple food vendors recruited to provide food to the public for a time period not to exceed three (3) consecutive days or no more than seventy-two (72) continuous hours. Each community festival is unique and will not be held more frequently than annually, although a sponsoring organization or group might have multiple but differently themed community festivals in a year.

(19) "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 retail food establishment or food processing plant, and does not offer the food for resale.

(20)"Core violation" See (132) "Violations."

(21)"Corrosion-resistant materials" 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.

(22)"Counter-mounted equipment" means equipment that is not portable and is designed to be mounted off the floor on a table, counter, or shelf.

(23)"Critical control point" means a point or procedure in a specific food system where loss of control may result in an unacceptable health risk.

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

(25)"Cut leafy greens" means fresh leafy greens whose leaves have been further cut, shredded, sliced, chopped, or torn beyond any cut made to harvest intact leaves from a plant. The term "cut leafy greens" does not apply to leaves harvested intact from a plant. 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.

(26)"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.

(27)"Department" means the South Carolina Department of Health and Environmental Control or agents thereof having responsibility for enforcing these regulations.

(28)"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.

(29)Drinking Water.

(a)"Drinking water" means water that meets criteria as specified in 40 CFR 141, National Primary Drinking Water Regulations and R.61-58, State Primary Drinking Water Regulation.

(b)"Drinking water" is traditionally known as "potable water."

(c)"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.

(30)"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.

(31)Easily cleanable.

(a)"Easily cleanable" means a characteristic of a surface that:

(i) Allows effective removal of soil by normal cleaning methods;

(ii) Is dependent on the material, design, construction, and installation of the surface; and

(iii) 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.

(b)"Easily cleanable" includes a tiered application of the criteria that qualify the surface as easily cleanable as specified in (a) of this definition to different situations in which varying degrees of cleanability are required such as:

(i) 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

(ii) 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.

(32)"Easily movable" means:

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

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

(33)Egg.

(a)"Egg" means the shell egg of an avian species such as chicken, duck, goose, guinea, quail, ratites or turkey.

(b)"Egg" does not include:

(i) A balut;

(ii) The egg of reptile species such as alligator; or

(iii) An egg product.

(34)Egg product.

(a)"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.

(b)"Egg Product" does not include food which contains eggs only in a relatively small proportion such as cake mixes.

(35)"Employee" means the permit holder, person in charge, food employee, person having supervisory or managerial duties, person on the payroll, family member, volunteer, person performing work under a contractual agreement, or any other person working in a retail food establishment.

(36)"EPA" means the U.S. Environmental Protection Agency.

(37)Equipment.

(a)"Equipment" means an article that is used in the operation of a retail food establishment such as a freezer, grinders, hood, ice makers, meat block, mixer, oven, reach-in refrigerators, scale, sinks, slicer, stove, table temperature measuring device for ambient air, or warewashing machine.

(b)"Equipment" does not include 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.

(38)"Exclude" means to prevent a person from working as an employee in a retail food establishment or entering a retail food establishment as an employee.

(39)"FDA" means the U. S. Food and Drug Administration.

(40)Fish.

(a)"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.

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

(41)"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.

(42)"Foodborne disease outbreak" means the occurrence of two or more cases of a similar illness resulting from the ingestion of a common food.

(43) "Food-contact surface" means:

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

(b) A surface of equipment or a utensil from which food may drain, drip, or splash:

(i) Into a food, or

(ii) Onto a surface normally in contact with food.

(44) "Food employee" means an individual working with unpackaged food, food equipment or utensils, or food-contact surfaces.

(45)Food processing plant.

(a) "Food processing plant" means a commercial operation that manufactures, packages, labels, or stores food for human consumption, and provides food for sale or distribution to other business entities such as food processing plants or retail food establishments.

(b) "Food processing plant" does not include a retail food establishment.

(46)Game animal.

(a)"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, Definitions, or as poultry or fish.

(b)"Game animal" 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.

(c)"Game animal" does not include ratites.

(47)"General use pesticide" means a pesticide that is not classified by EPA for restricted use as specified in 40 CFR 152.175, Pesticides Classified for Restricted Use.

(48)"Grade A standards" refers to milk that meets 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 or the requirements of the Department's R.61-34, Raw Milk for Human Consumption.

(49)"Grade decal" means an official decal issued by the Department that is posted by the Department in a retail food establishment, or on a mobile food unit or a mobile food pushcart that is representative of the most recent inspection.

(50)"HACCP (Hazard Analysis and Critical Control Point) 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.

(51)Handwashing sink.

(a)"Handwashing sink" means a lavatory, a basin for handwashing, or a plumbing fixture specifically placed for use in personal hygiene and designed for the washing of the hands.

(b)"Handwashing sink" includes an automatic handwashing facility.

(52)"Hazard" means a biological, chemical, or physical property that may cause an unacceptable consumer health risk.

(53)"Health practitioner" means a physician licensed to practice medicine, or if allowed by law, a nurse practitioner, physician assistant, or similar medical professional.

(54)"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 food, is able to maintain the commercial sterility of its contents after processing.

(55)"Highly susceptible population" means persons who are more likely than other people in the general population to experience foodborne disease because they are:

(a) Immunocompromised; preschool age children or older adults; and

(b) 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.

(56)"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 illness or injury based on:

(a) The number of potential illnesses or injuries, and

(b) The nature, severity, and duration of the anticipated illness or injury.

(57)"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."

(58)"Intact Meat" means a cut of whole muscle(s) meat that has not undergone comminution, injection, mechanical tenderization, or reconstruction.

(59)Juice.

(a)"Juice" means the aqueous liquid expressed or extracted from one or more fruits, or vegetables, purées of the edible portions of one or more fruits or vegetables, or any concentrates of such liquid or purée.

(b)"Juice" does not include, for purposes of HACCP, liquids, purées, or concentrates that are not used as beverages or ingredients of beverages.

(60)"Kitchenware" means food preparation and storage utensils.

(61)"Law" means applicable local, state, and federal statutes, regulations, and ordinances.

(62)"Linens" means fabric items such as cloth hampers, cloth napkins, tablecloths, wiping cloths, and work garments including cloth gloves.

(63)"Low-risk food processes" means food processes that have been determined and approved by the Department to be low risk. The Department will evaluate low-risk food processes based on food items, food handling and preparation, and foodborne illness.

(64)Major Food Allergen.

(a)"Major food allergen" means:

(i) 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, and soybeans; or

(ii) A food ingredient that contains protein derived from a food, as specified in (a)(i) of this definition.

(b)"Major food allergen" does not include:

(i) Any highly refined oil derived from a food specified in (a)(i) of this definition and any ingredient derived from such highly refined oil; or

(ii) 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).

(65)"Meat" means the flesh of animals used as food including the dressed flesh of cattle, swine, sheep, goats, or other edible animals, except fish, poultry, and game animals as specified under 3-201.17(A)(3) and (4).

(66)Mechanically tenderized.

(a)"Mechanically tenderized" means manipulating meat with deep penetration by processes which may be referred to as "blade tenderizing," "jaccarding," "pinning," "needling," or using blades, pins, needles or any mechanical device.

(b)"Mechanically tenderized" does not include processes by which solutions are injected into meat.

(67)"mg/L" means milligrams per liter, which is the metric equivalent of parts per million (ppm).

(68)"Mobile food establishment" means a retail food establishment that consists of a commissary and mobile food units or mobile food pushcarts.

(69)"Mobile food unit" means fully enclosed mobile kitchens that prepare, cook, or serve time/temperature control for safety food as an extension of a commissary.

(70)"Mobile food pushcart" means limited food service units that operate as an extension of a commissary.

(71)"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.

(72)Non-continuous cooking.

(a)"Non-continuous cooking" means the cooking of food in a retail 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.

(b)"Non-continuous cooking" does not include cooking procedures that only involve temporarily interrupting or slowing an otherwise continuous cooking process.

(73)"Nuisance" for the purpose of this Regulation is a public health nuisance and means whatever is dangerous to human life or detrimental to health, including but not limited to whatever structure or premises is not sufficiently ventilated, sewered, drained, cleaned, or lighted with respect to its intended occupancy.

(74)Packaged.

(a)"Packaged" means bottled, canned, cartoned, bagged, or wrapped, whether packaged in a retail food establishment or a food processing plant.

(b)"Packaged" does not include wrapped or placed in a carry-out container to protect the food during service or delivery to the consumer by a food employee upon consumer request.

(75)"Permit" means the document issued by the Department that authorizes a person or entity to operate a retail food establishment.

(76)"Permit holder" means the entity that:

(a) Is legally responsible for the operation of the retail food establishment such as the owner, the owner's agent, or other person; and

(b) Possesses a valid permit to operate a retail food establishment.

(77)"Person" means an association, a corporation, individual, partnership, other legal entity, government, or governmental subdivision or agency.

(78)"Person in charge" means the individual present at a retail food establishment who is responsible for the operation at the time of inspection.

(79)Personal care items.

(a)"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.

(b)"Personal care items" include items such as medicines, first aid supplies, cosmetics, and toiletries such as toothpaste and mouthwash.

(80)"pH" means the symbol for the negative logarithm of the hydrogen ion concentration, which it is a measure of the degree of the acidity or alkalinity of a solution. Values between zero (0) and seven (7.0) indicate acidity and values between seven (7.0) and fourteen (14.0) indicate alkalinity. The value for pure distilled water is seven (7.0), which is considered neutral.

(81)"Physical facilities" means the structure and interior surfaces of a retail food establishment including accessories such as soap and towel dispensers and attachments such as light fixtures and heating or air conditioning system vents.

(82)"Plumbing fixture" means a receptacle or device that:

(a) Is permanently or temporarily connected to the water distribution system of the premises and demands a supply of water from the system; or

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

(83)"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.

(84)"Poisonous or toxic materials" means substances that are not intended for ingestion and are included in 4 categories:

(a) Cleaners and sanitizers, which include cleaning and sanitizing agents and agents such as caustics, acids, drying agents, polishes, and other chemicals;

(b) Pesticides, except sanitizers, which include substances such as insecticides and rodenticides;

(c) Substances necessary for the operation and maintenance of the retail food establishment such as nonfood grade lubricants and personal care items that may be deleterious to health; and

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

(85)"Poultry" means:

(a) 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

(b) 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.

(86)"Premises" means:

(a) The physical facility, its contents, its land, and any adjacent or bordering contiguous land or property under the control of the permit holder; or

(b) The physical facility, its contents, and land or property not described in (a) of this definition if its facilities, contents, or land that are under the control of the permit holder and may impact the retail food establishment personnel, facilities, or operations, and the retail food establishment is only one component of a larger operation such as a healthcare facility, hotel, motel, school, recreational camp, or prison.

(87)"Pre-operational inspection" means an inspection conducted by the Department to determine compliance with the regulation for the purpose of obtaining a permit.

(88) "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.

(89)Priority violation See (132) "Violations."

(90)Priority foundation violation See (132) "Violations."

(91)"Private residence" means a domestic home or dwelling in which food is prepared or served for individual and family consumption. A private residence is exempt from compliance with this regulation.

(92)"Process authority" means a qualified person(s) approved by the Department who have expert knowledge and adequate facilities to assess and determine safe food handling and processing requirements, including but not limited to thermal processing requirements in hermetically sealed containers, reduced oxygen packaging, shelf stable non-time/temperature control for safety foods, and cooking processes.

(93)"Product assessment" means a process by which a retail food establishment submits food to be tested at a lab approved by Department to determine if the food is time/temperature control for safety or non-time/temperature control for safety. A product assessment shall test intrinsic and extrinsic factors necessary to determine if the food is capable of supporting the growth or toxic formation of pathogenic microorganisms.

(94)"Public water system" has the meaning stated in 40 CFR 141, National Primary Drinking Water Regulations and R.61-58, State Primary Drinking Water Regulation.

(95)"Ratite" means a flightless bird such as an emu, ostrich, or rhea.

(96)"Raw milk" refers to milk that has not been pasteurized and that is approved for sale and human consumption in South Carolina under the Department's R.61-34, Raw Milk for Human Consumption.

(97)Ready-to-Eat Food.

(a)"Ready-to-eat food" means food that:

(i) Is in a form that is edible without additional preparation to achieve food safety, as specified under one of the following: 3-401.11(A) or (B), 3-401.12, or 3-402.11, or as specified in 3-401.11(C); or

(ii) Is a raw or partially cooked animal food and the consumer is advised as specified in 3-401.11(D)(1) and (3); or

(iii) Is prepared in accordance with a variance that is granted as specified in 3-401.11(D) (4); and

(iv) May receive additional preparation for palatability or aesthetic, epicurean, gastronomic, or culinary purposes.

(b)"Ready-to-eat food" includes:

(i) Raw animal food that is cooked as specified under 3-401.11 or 3-401.12, or frozen as specified under 3-402.11;

(ii) Raw fruits and vegetables that are washed as specified under 3-302.15;

(iii) Fruits and vegetables that are cooked for hot holding, as specified under 3-401.13;

(iv) All time/temperature control for safety food that is cooked to the temperature and time required for the specific food under 3-401 and cooled as specified under 3-501.14;

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

(vi) Substances derived from plants such as spices, seasonings, and sugar;

(vii) A bakery item such as bread, cakes, pies, fillings, or icing for which further cooking is not required for food safety;

(viii) The following products that are produced in accordance with USDA guidelines and that have received a lethality treatment for pathogens: dry, fermented sausages such as dry salami or pepperoni; salt-cured meat and poultry products such as prosciutto ham, country cured ham, and Parma ham; and dried meat and poultry products such as jerky or beef sticks; and

(ix) Foods manufactured as specified in 21 CFR Part 113, Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers.

(98)Reduced Oxygen Packaging.

(a)"Reduced oxygen packaging" means:

(i) The reduction of the amount of oxygen in a package by removing oxygen; displacing oxygen and replacing it with another gas or combination of gases; or otherwise controlling the oxygen content to a level below that normally found in the atmosphere (approximately twenty-one (21) percent at sea level); and

(ii) A process as specified in (a)(i) of this definition that involves a food for which the hazards Clostridium botulinum or Listeria monocytogenes require control in the final packaged form.

(b)"Reduced oxygen packaging" includes:

(i) 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;

(ii) 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;

(iii) 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;

(iv) Cook chill packaging in which cooked food is hot filled into impermeable bags which have the air expelled and are then sealed or crimped closed. The bagged food is rapidly chilled and refrigerated at temperatures that inhibit the growth of psychrotrophic pathogens; or

(v) 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 temperatures that inhibit the growth of psychrotrophic pathogens.

(99)"Refuse" means solid waste not carried by water through the sewage system.

(100)"Regulation" refers to Regulation 61-25.

(101)"Reminder" means a written statement concerning the health risk of consuming animal foods raw, undercooked, or without otherwise being processed to eliminate pathogens.

(102)"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.

(103) "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.

(104)"Restricted egg" means any check, dirty egg, incubator reject, inedible, leaker, or loss as defined in 9 CFR 590.

(105)"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.

(106)"Retail food establishment" means an operation that prepares, processes, packages, serves, or otherwise provides food for human consumption, either on or off the premises, regardless of whether there is a charge for the food. These establishments include, but are not limited to, restaurants, delicatessens, snack bars, catering operations, ice cream parlors, school cafeterias, independent living food service operations, licensed healthcare facilities, grocery stores, retail meat markets, fish/seafood markets, retail ice merchants, shared use operations, and mobile food establishments (to include the associated commissary and mobile units).

(107)"Risk" means the likelihood that an adverse health effect will occur within a population as a result of a hazard in a food.

(108)"Safe material" means:

(a) 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.

(b) An additive that is used as specified in 409 of the Federal Food, Drug, and Cosmetic Act; or

(c) Other materials that are not additives and that are used in conformity with applicable regulations of the Food and Drug Administration.

(109)"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 5 logs, which is equal to a 99.999 percent reduction, of representative disease microorganisms of public health importance.

(110)"Sealed" means free of cracks or other openings that allow the entry or passage of moisture.

(111)"Seasonal series" means a regularly occurring event sponsored by a community or governmental organization for promoting local business, culture, or other local specialties.

(112)"Service animal" means an animal such as a guide dog, signal dog, or other animal individually trained to provide assistance to an individual with a disability as per the Americans for Disabilities Act. Service animal does not include emotional, comfort, or similar support animals not recognized under the Americans with Disabilities Act (ADA) regulations as service animals.

(113)"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.

(114)"Sewage" means liquid waste containing animal or vegetable matter in suspension or solution and may include liquids containing chemicals in solution.

(115)"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.

(116)"Shellstock" means raw in-shell molluscan shellfish.

(117)"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., bloody diarrhea), to hemolytic uremic syndrome (HUS - a type of kidney failure). Examples of serotypes of STEC include: E.coli O157:H7; NM E.coli O26:H11; 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 which can cause hemorrhagic colitis or HUS.

(118) "Shucked shellfish" means molluscan shellfish that have one of both shells removed.

(119)"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.

(120)Single-use articles.

(a)"Single-use articles" means utensils and bulk food containers designed and constructed to be used once and discarded.

(b)"Single-use articles" means food packaging and other items such as wax paper, butcher paper, plastic wrap, formed aluminum food containers, jars, plastic tubs or buckets, bread wrappers, pickle barrels, ketchup bottles, and number 10 (ten) cans which do not meet the materials, durability, strength, and cleanability specifications under 4-101.11, 4-201.11, and 4-202.11 for multiuse utensils.

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

(122)"Smooth" means:

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

(b) A non-food-contact surface of equipment having a surface equal to that of commercial grade hot-rolled steel free of visible scale; and

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

(123)"Standard Operating Procedures (SOPs)" means established or prescribed methods to be followed for the performance of designated operations or in designated situations as determined by the Department.

(124)"Tableware" means eating, drinking, and serving utensils for table use such as flatware including forks, knives, spoons; hollowware including bowls, cups, serving dishes, tumblers, and plates.

(125)"Temperature measuring device" means a thermometer, thermocouple, thermistor, or other device that indicates the temperature of food, air, or water.

(126)"Temporary food establishment" means an establishment that may be authorized by the Department to operate at a fixed location for a period of time not to exceed fourteen (14) consecutive days in connection with a fair, carnival, circus, trade show, golf, or other national sporting event and other transitory gatherings organized by the community.

(127)Time/temperature control for safety food (formerly "potentially hazardous food" (PHF)).

(a)"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.

(b) "Time/temperature control for safety food" includes:

(i) 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

(ii) Except as specified in (c)(iv) of this definition, a food that because of the interaction of its Aw and pH values is designated as Product Assessment Required (PA) in Table (A) or (B) of this definition:

Table A. Interaction of pH and Aw for control of spores in food heat-treated to destroy vegetative cells and subsequently packaged.
Aw values
	pH: 4.6 or less	pH: Greater than 4.6 - 5.6	pH: Greater than 5.6
Less than or equal to 0.92	non-TCS Food*	non-TCS Food	non-TCS Food
Greater than 0.92 - 0.95	non-TCS Food	non-TCS Food	PA**
Greater than 0.95	non-TCS Food	PA	PA
* TCS Food means Time/Temperature Control For Safety Food ** PA means Product Assessment required

Table B. Interaction of pH and Aw for control of vegetative cells and spores in food not heattreated or heat treated but not packaged.
Aw values
	pH: Less than 4.2	pH: 4.2 - 4.6	pH: Greater than 4.6 - 5.0	pH: Greater than 5.0
Less than 0.88	non-TCS Food*	non-TCS Food	non-TCS Food	non-TCS
0.88 - 0.90	non-TCS	non-TCS	non-TCS Food	PA**
Greater than 0.90 - 0.92	non-TCS	non-TCS	PA	PA
Greater than 0.92	non-TCS	PA	PA	PA

* TCS Food means Time/Temperature Control For Safety Food ** PA means Product Assessment required

(c)"Time/temperature control for safety food" does not include:

(i) An air-cooled hard-boiled egg with shell intact, or an egg with shell that is not hard-boiled but has been pasteurized to destroy all viable Salmonellae;

(ii) A food in an unopened hermetically sealed container that is commercially processed to achieve and maintain commercial sterility under conditions of non-refrigerated storage and distribution;

(iii) 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 A or B of this definition;

(iv) A food that is designated TCS* and a product assessment (PA) required in Table A or B of this definition 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:

(aa) Intrinsic factors including added or natural characteristics of the food such as preservatives, antimicrobials, humectants, acidulants, or nutrients;

(bb) Extrinsic factors including environmental or operational factors that affect the food such as packaging, modified atmospheric such as reduced oxygen packaging, shelf life and use, or temperature range of storage and use; or

(cc) A combination of intrinsic and extrinsic factors; or

(v) A food that does not support the growth or toxin formation of pathogenic microorganisms in accordance with one of the (c)(i) through (c)(iv) 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.

(128)"USDA" means the U.S. Department of Agriculture.

(129)"Utensil" means a food-contact implement or container used in the storage, preparation, transportation, dispensing, sale, or service of food, such as kitchenware or tableware that is multiuse, single-service, or single-use; gloves used in contact with food; temperature-sensing probes of food temperature measuring devices; and probe-type price or identification tags used in contact with food.

(130)"Variance" means a written document issued by the Department that authorizes a modification or waiver of one or more requirements of this regulation if, in the opinion of the Department, a health hazard or nuisance will not result from the modification or waiver.

(131)"Vending machine" means a self-service device that, upon insertion of a coin, paper currency, token, card, or key, or by optional manual operation, dispenses unit servings of food in bulk or in packages without the necessity of replenishing the device between each vending operation.

(132)Violations.

(a)Priority violation.

(i)"Priority violation" means the violation of a provision in this Regulation whose application contributes directly to the elimination, prevention or reduction to an acceptable level, hazards associated with foodborne illness or injury and there is no other provision that more directly controls the hazard. Priority violations are denoted in this regulation by the superscript ^"P".

(ii)"Priority violation" includes violations with a quantifiable measure to show control of hazards such as cooking, reheating, cooling, handwashing.

(b)Priority Foundation violation.

(i)"Priority foundation violation" means the violation of a provision in this Regulation whose application supports, facilitates or enables one or more priority violations. Priority foundation violations are denoted in this regulation by the superscript ^"Pf".

(ii)"Priority foundation violation" includes a violation that requires the purposeful incorporation of specific actions, equipment or procedures by industry management to attain control of risk factors that contribute to foodborne illness or injury such as personnel training, infrastructure or necessary equipment, HACCP plans, documentation or record keeping, and labeling.

(c)Core violation.

(i)"Core violation" means the violation of a provision in this Regulation that is not designated as a priority item or a priority foundation violation.

(ii)"Core violation" includes a violation that usually relates to general sanitation, operational controls, sanitation standard operating procedures (SSOPs), facilities or structures, equipment design, or general maintenance.

(d)"Consecutive violation" means a priority or priority foundation or core violation that was recorded on routine or complaint inspection(s), and is recorded on consecutive routine or complaint inspection(s). Consecutive violations are the same violation citation and similar in nature.

(133) "Warewashing" means the cleaning and sanitizing of food-contact surfaces of equipment and utensils.

(134)"Whole-muscle, intact beef" means whole muscle beef that is not injected, mechanically tenderized, reconstructed, or scored and marinated, from which beef steaks may be cut.

S.C. Code Regs. § 61-25.1-201

Replaced and amended by State Register Volume 38, Issue No. 6, eff 6/27/2014; State Register Volume 43, Issue No. 05, eff. 5/24/2019.