(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.