South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-25 - Retail Food Establishments › Chapter 61-25.1 - PURPOSE AND DEFINITIONS › Part 61-25.1-2 - DEFINITIONS › Section 61-25.1-201 - Applicability and Terms Defined

Current through Register Vol. 48, No. 6, June 28, 2024
1-201.10
Statement 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)
"Aw"
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.