(1) Statement of Application and Listing of
Terms.
(a) The following definitions shall
apply in the interpretation and application of these Regulations.
(b) Terms Defined. As used in these
Regulations, each of the terms listed in
40-7-1-.02(1)(b)
shall have the meaning stated below.
1.
Accredited program.
(i)
"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.
(ii)
"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.
(iii)
"Accredited program"
does not refer to
training functions or educational programs.
2.
Additive.
(i)
"Food additive" has the
meaning stated in the Federal Food, Drug, and Cosmetic Act, § 201(s) and
21 CFR
170.3(e)(1).
(ii)
"Color additive" has the
meaning stated in the Federal Food, Drug, and Cosmetic Act, § 201(t) and
21 CFR
70.3(f).
3.
"Adulterated" has the meaning
stated in the Official Code of Georgia Annotated (O.C.G.A.) §
26-2-26, and the Federal Food,
Drug, and Cosmetic Act, § 402.
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.
Asymptomatic.(i)
"Asymptomatic" means without obvious symptoms; not showing or
producing indications of a disease or other medical condition, such as an
individual infected with a pathogen but not exhibiting or producing any signs
or symptoms of vomiting, diarrhea, or jaundice.
(ii)
"Asymptomatic" includes not
showing symptoms because symptoms have resolved or subsided, or because
symptoms never manifested.
6.
"Aw"
means water activity which is a measure of the free moisture in a FOOD, is the
quotient of the water vapor pressure of the substance divided by the vapor
pressure of pure water at the same temperature, and is indicated by the symbol
AW.
7.
"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.
8.
"Beverage" means a liquid for drinking, including water.
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, or 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 these Regulations 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.
(i)
"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.
(ii)
"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:
(i) To combine SHELLSTOCK harvested on
different days or from different growing areas as identified on the tag or
label, or
(ii) To combine SHUCKED
SHELLFISH from containers with different container codes or different shucking
dates.
15.
Comminuted.(i)
"Comminuted" means reduced in size by methods including chopping,
flaking, grinding, or mincing.
(ii)
"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, such as sausages made from two (2) or more MEATS.
16.
"Conditional
employee" means a potential FOOD EMPLOYEE to whom a job offer is made,
conditional on responses to subsequent medical questions or examinations
designed to identify potential FOOD EMPLOYEES who may be suffering from a
disease that can be transmitted through FOOD and done in compliance with Title
1 of the Americans with Disabilities Act of 1990.
17.
"Confirmed disease outbreak"
means a FOODBORNE DISEASE OUTBREAK in which laboratory analysis of appropriate
specimens identifies a causative agent and epidemiological analysis implicates
the FOOD as the source of the illness.
18.
"Consumer" means a PERSON
who is a member of the public, takes possession of FOOD, is not functioning in
the capacity of an operator of a FOOD ESTABLISHMENT or FOOD PROCESSING PLANT,
and does not offer the FOOD for resale.
19.
Core item.
(i)
"Core item" means a
provision in these Regulations that is not designated as a PRIORITY ITEM or a
PRIORITY FOUNDATION ITEM.
(ii)
"Core item" includes an item that usually relates to general
sanitation, operational controls, sanitation standard operating procedures
(SSOPs), facilities or structures, equipment design, or general maintenance.
20.
"Corrosion-resistant material" means a material that maintains
acceptable surface cleanability characteristics under prolonged influence of
the FOOD to be contacted, the normal use of cleaning compounds and SANITIZING
solutions, and other conditions of the use environment.
21.
"Counter-mounted equipment"
means EQUIPMENT that is not portable and is designed to be mounted off the
floor on a table, counter, or shelf.
22.
"Critical control point"
means a point or procedure in a specific FOOD system where loss of control may
result in an unacceptable health RISK.
23.
"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.
24.
"Cut leafy greens" means
fresh leafy greens whose leaves have been cut, shredded, sliced, chopped, or
torn. The term "leafy greens" includes iceberg lettuce, romaine lettuce, leaf
lettuce, butter lettuce, baby leaf lettuce - i.e. immature lettuce or leafy
greens, escarole, endive, spring mix, spinach, cabbage, kale, arugula, and
chard. The term "leafy greens" does not include herbs such as cilantro or
parsley.
25.
"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.
26.
"Department" means the
Georgia Department of Agriculture.
27.
"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.
28.
Drinking Water.
(i)
"Drinking water" means water
that meets criteria as specified in 40 CFR 141 National Primary Drinking Water
Regulations.
(ii)
"Drinking
water" is traditionally known as "potable water."
(iii)
"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.
29.
"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.
30.
Easily Cleanable.(i)
"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.
(ii)
"Easily cleanable" includes a tiered application of the criteria
that qualify the surface as EASILY CLEANABLE as specified in Subparagraph (i)
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.
31.
"Easily movable" means:
(i) Portable; mounted on casters, gliders, or
rollers; or provided with a mechanical means to safely tilt a unit of EQUIPMENT
for cleaning; and
(ii) 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.
32.
Egg.
(i)
"Egg" means the shell EGG of
avian species such as chicken, duck, goose, guinea, quail, RATITES or
turkey.
(ii)
"Egg"
does not include:
(I)
A BALUT;
(II)
The egg of reptile species such
as alligator; or
(III)
An EGG PRODUCT.
33.
Egg Product.
(i)
"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.
(ii)
"Egg
Product"
does not include FOOD which contains EGGS only
in a relatively small proportion such as cake
mixes.
34.
"Employee" means the LICENSE HOLDER, PERSON IN CHARGE, FOOD
EMPLOYEE, PERSON having supervisory or management duties, PERSON on the
payroll, family member, volunteer, PERSON performing work under contractual
agreement, or other PERSON working in a FOOD ESTABLISHMENT.
35.
"EPA" means the U.S.
Environmental Protection Agency.
36.
Equipment.
(i)
"Equipment" means an article
that is used in the operation of a FOOD ESTABLISHMENT, such as a freezer,
grinder, hood, ice maker, MEAT block, mixer, oven, reach-in refrigerator,
scale, sink, slicer, stove, table, TEMPERATURE MEASURING DEVICE for ambient
air, VENDING MACHINE, or WAREWASHING machine.
(ii)
"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.
37.
"Exclude" means to prevent a
PERSON from working as an EMPLOYEE in a FOOD ESTABLISHMENT or entering a FOOD
ESTABLISHMENT as an EMPLOYEE.
38.
"Expiration Date" is synonymous with Pull Date, Best-By Date, Best
Before Date, Use-By Date, and Sell-By Date; and means the last date on which
the following FOOD products can be sold at retail or wholesale:
(i) EGGS;
(ii) Infant formula;
(iii) Milk;
(iv) Shucked oysters; and
(v) TIME/TEMPERATURE CONTROL FOR SAFETY FOOD,
or any FOOD that is labeled as "keep refrigerated."
39.
"FDA" means the U.S. Food
and Drug Administration.
40.
Fish.
(i)
"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.
(ii)
"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, or chewing
gum.
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:
(i) A surface of EQUIPMENT or a UTENSIL
with which FOOD normally comes into contact; or
(ii) 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 Establishment.
(i)
"Food establishment" means:
(I)
Retail and wholesale grocery stores; retail seafood stores and places of
business; FOOD PROCESSING PLANTS, except those FOOD PROCESSING PLANTS which are
currently required to obtain a LICENSE from the Commissioner under any other
provision of LAW; bakeries; confectioneries; fruit, nut, and vegetable stores
or roadside stands; wholesale sandwich and salad manufacturers, including
VENDING MACHINES and operations connected therewith; and places of business and
similar establishments, mobile or permanent, engaged in the sale of FOOD
primarily for consumption off PREMISES.
I.
Within a FOOD ESTABLISHMENT, there may be a FOOD service component, not
separately operated, which may serve customers on site. This FOOD service
component shall be considered as part of the FOOD ESTABLISHMENT.
II. Within a FOOD ESTABLISHMENT primarily
operating as a retail firm with sales to the end CONSUMER, there may be a FOOD
PROCESSING PLANT not separately owned and operated. In these types of blended
operations, the retail sales are governed by these Regulations, and the FOOD
PROCESSING PLANT shall be subject to the regulations in 40-7-18 Manufactured
Food Operations.
(II)
Cottage food operations. See DEPARTMENT rules Chapter 40-7-19 for regulations
and requirements specific to cottage food operations.
(ii)
"Food
establishment"
does not include:
(I) "Food Service Establishments," as
defined in the Official Code of Georgia Annotated Section
26-2-370, which are permitted by
local health departments.
(II)
This term also shall not include
establishments engaged in the sale of FOOD primarily for consumption off the
PREMISES if such sale is an authorized part of and occurs upon the site of a
fair or festival which:
I.
Is sponsored by a political subdivision of this state or by an
organization exempt from taxes under paragraph (1) of subsection (a) of Code
Section 48-7-25 or under Section 501(d) or
paragraphs (1) through (8) or paragraph (10) of Section
501(c) of the Internal
Revenue Code, as that code is defined in Code Section
48-1-2;
II.
Lasts 120 hours or less;
and
III.
When
sponsored by such an organization, is authorized to be conducted pursuant to a
permit issued by the municipality or county in which it is
conducted.
(III)
Establishments engaged in the
boiling, bottling, and sale of sugar cane syrup or sorghum syrup within this
state, provided that such bottles contain a label listing the producer's name
and street address, all added ingredients, and the net weight or volume of the
product.
46.
Food Processing Plant.
(i)
"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 FOOD
ESTABLISHMENTS.
(ii)
"Food
processing plants" operate under DEPARTMENT regulations 40-7-18
Manufactured Food Operations.
47.
Game Animal.
(i)
"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.
(ii)
"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.
(iii)
"Game
animal"
does not include
RATITES.
48.
"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.
49.
"Grade A
Standards" means the requirements of the United States Public Health
Service/FDA "Grade A Pasteurized Milk Ordinance" with which certain fluid and
dry milk and milk products comply.
50.
"HACCP plan" means a written
document that delineates the formal procedures for following the Hazard
Analysis and Critical Control Point principles developed by The National
Advisory Committee on Microbiological Criteria for Foods.
51.
Handwashing Sink.
(i)
"Handwashing sink" means a
lavatory, a basin or vessel for washing, a wash basin, or PHYSICAL FACILITIES
especially placed for use in personal hygiene and designed for the washing of
the hands.
(ii)
"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 FOODS, 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:
(i) Immunocompromised; preschool age
children, or older adults; and
(ii)
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 injury based on:
(i) The
number of potential injuries, and
(ii) The nature, severity, and duration of
the anticipated 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,
MECHANIAL TENDERIZATION, or reconstruction.
59.
Juice.
(i)
"Juice" means the aqueous
liquid expressed or extracted from one or more fruits or vegetables, purees of
the edible portions of one or more fruits or vegetables, or any concentrates of
such liquid or puree.
(ii)
"Juice"
does not include, for purposes of
HACCP, liquids, puree, 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.
"License" means the document
issued by the DEPARTMENT that authorizes a PERSON to operate a FOOD
ESTABLISHMENT.
63.
"License
holder" means the entity that:
(i) Is
legally responsible for the operation of the FOOD ESTABLISHMENT such as the
owner, the owner's agent, or other PERSON; and
(ii) Possesses a valid LICENSE to operate a
FOOD ESTABLISHMENT.
64.
"Linens" means fabric items such as cloth hampers, cloth napkins,
table cloths, wiping cloths, and work garments including cloth
gloves.
65.
Major Food
Allergen.(i)
"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
Subparagraph (i)(I) of this definition.
(ii)
"Major food
allergen"
does not include:
(I)
Any highly refined oil derived
from a FOOD specified in Subparagraph (i)(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).
66.
"Meat" means the flesh of animals used as FOOD including the
dressed flesh of cattle, swine, sheep, or goats and other edible animals,
except FISH, POULTRY, and wild GAME ANIMALS as specified under
Subparagraphs
40-7-1-.09(7)(a)3
and 4.
67.
Mechanically Tenderized.
(i)
"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.
(ii)
"Mechanically tenderized"
does not
include processes by which solutions are INJECTED into
meat.
68.
"mg/L" means milligrams per liter, which is the metric equivalent
of parts per million (ppm).
69.
"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.
70.
Non-Continuous Cooking.
(i)
"Non-continuous cooking" means the cooking of FOOD in a FOOD
ESTABLISHMENT using a process in which the initial heating of the FOOD is
intentionally halted so that it may be cooled and held for complete cooking at
a later time prior to sale or service.
(ii)
"Non-continuous
cooking"
does not include cooking procedures that only
involve temporarily interrupting or slowing an otherwise continuous cooking
process.
71.
Packaged.
(i)
"Packaged" means bottled, canned, cartoned, bagged, or wrapped,
whether PACKAGED in a FOOD ESTABLISHMENT or a FOOD PROCESSING PLANT.
(ii)
"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.
72.
"Person" means an
association, a corporation, individual, partnership, other legal entity,
government, or governmental subdivision or agency.
73.
"Person in charge" means the
individual present at a FOOD ESTABLISHMENT who is responsible for the operation
at the time of inspection.
74.
Personal Care Items.
(i)
"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.
(ii)
"Personal care items"
include items such as medicines; first aid supplies; and other items such as
cosmetics and toiletries, such as toothpaste and mouthwash.
75.
"pH"
means the symbol for the negative logarithm of the hydrogen ion concentration,
which is a measure of the degree of acidity or alkalinity of a solution.
Values between 0 and 7 indicate acidity and values between 7
and 14 indicate alkalinity.
The value for pure distilled water is 7, which is considered
neutral.
76.
"Physical
facilities" means the structure and interior surfaces of a FOOD
ESTABLISHMENT including accessories such as soap and towel dispensers and
attachments such as light fixtures and heating or air conditioning system
vents.
77.
"Plumbing
fixture" means a receptacle or device that:
(i) Is permanently or temporarily connected
to the water distribution system of the PREMISES and demands a supply of water
from the system; or
(ii) Discharges
used water, waste materials, or SEWAGE directly or indirectly to the drainage
system of the PREMISES.
78.
"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.
79.
"Poisonous or toxic materials" means substances that are not
intended for ingestion and are included in four (4) categories:
(i) Cleaners and SANITIZERS, which include
cleaning and SANITIZING agents and agents such as caustics, acids, drying
agents, polishes, and other chemicals;
(ii) Pesticides, except
SANITIZERS, which include substances such as insecticides and
rodenticides;
(iii) Substances
necessary for the operation and maintenance of the establishment such as
nonfood grade lubricants and PERSONAL CARE ITEMS that may be deleterious to
health; and
(iv) Substances that
are not necessary for the operation and maintenance of the establishment and
are on the PREMISES for retail sale, such as petroleum products and paints.
80.
"Poultry" means:
(i) 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
(ii) 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.
81.
"Premises" means:
(i) The PHYSICAL FACILITY, its contents, and
the contiguous land or property under the control of the LICENSE HOLDER;
or
(ii) The PHYSICAL FACILITY, its
contents, and the land or property not described in Subparagraph (i) of this
definition if its facilities and contents are under the control of the LICENSE
HOLDER and may impact FOOD ESTABLISHMENT personnel, facilities, or operations,
and a FOOD ESTABLISHMENT is only one component of a larger operation such as a
health care facility, hotel, motel, school, recreational camp, or prison.
82.
"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.
83.
Priority
Item.(i)
"Priority item"
means a provision in these Regulations 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.
(ii)
"Priority item" includes
items with a quantifiable measure to show control of hazards such as cooking,
reheating, cooling, handwashing; and
(iii)
"Priority item" is an item
that is denoted in these Regulations with a superscript P -
P.
84.
Priority Foundation Item.
(i)
"Priority foundation item"
means a provision in these Regulations whose application supports, facilitates
or enables one or more PRIORITY ITEMS.
(ii)
"Priority foundation item"
includes an item 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; and
(iii)
"Priority foundation item"
is an item that is denoted in these Regulations with a superscript Pf -
Pf.
85.
"Public water system" has
the meaning stated in 40 CFR 141 National Primary Drinking Water
Regulations.
86.
"Ratite" means a flightless bird such as an emu, ostrich, or
rhea.
87.
Ready-to-Eat
Food(i)
"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:
40-7-1-.11(1)(a) or
(b),
40-7-1-.11(2), or
40-7-1-.11(5), or as
specified in
40-7-1-.11(1)(c);
or
(II) Is a raw or partially
cooked animal FOOD and the CONSUMER is advised as specified in Subparagraphs
40-7-1-.11(1)(d)1
and 3; or
(III) Is prepared in
accordance with a variance that is granted as specified in Subparagraph
40-7-1-.11(1)(d)4;
and
(IV) May receive additional
preparation for palatability or aesthetic, epicurean, gastronomic, or culinary
purposes.
(ii)
"Ready-to-eat food" includes:
(I)
Raw animal FOOD that is cooked as specified under
40-7-1-.11(1) or
40-7-1-.11(2) or
frozen as specified under
40-7-1-.11(5);
(II) Raw fruits and vegetables that are
washed as specified under
40-7-1-.10(7);
(III) Fruits and vegetables that are cooked
for hot holding, as specified under
40-7-1-.11(3);
(IV) All TIME/TEMPERATURE CONTROL FOR SAFETY
FOOD that is cooked to the temperature and time required for the specific FOOD
under 40-7-1-.11(1) -
(4) and cooled as specified under
40-7-1-.12(4);
(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.
88.
Reduced Oxygen Packaging.
(i)
"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
21% at sea level; and
(II) A
process as specified in Subparagraph (i)(I) of this definition that involves a
FOOD for which the HAZARDS Clostridium botulinum
or Listeria monocytogenes require control in the
final PACKAGED form.
(ii)
"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.
89.
"Refuse" means solid waste not carried by water through the SEWAGE
system.
90.
"Regulatory
authority" means the local, state, or federal enforcement body or
authorized representative having jurisdiction over a FOOD ESTABLISHMENT or FOOD
PROCESSING PLANT.
91.
"Reminder" means a written statement concerning the health RISK of
consuming animal FOODS raw, undercooked, or without otherwise being processed
to eliminate pathogens.
92.
"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.
93.
"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.
94.
"Restricted egg" means any
check, dirty EGG, incubator reject, inedible, leaker, or loss as defined in 9
CFR 590.
95.
"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.
96.
"Risk" means the likelihood that an adverse health effect will
occur within a population as a result of a HAZARD in a FOOD.
97.
"Safe material" means:
(i) 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;
(ii)
An additive that is used as specified in § 409 of the Federal Food, Drug,
and Cosmetic Act; or
(iii) Other
materials that are not ADDITIVES and that are used in conformity with
applicable regulations of the Food and Drug Administration.
98.
"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%
reduction, of representative disease microorganisms of public health
importance.
99.
"Sealed" means free of cracks or other openings that allow the
entry or passage of moisture.
100.
"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.
101.
"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.
102.
"Sewage" means liquid waste
containing animal or vegetable matter in suspension or solution and may include
liquids containing chemicals in solution.
103.
"Shellfish control
authority" means a state, federal, foreign, tribal, or other government
entity legally responsible for administering a program that includes
certification of harvesters and DEALER s for interstate commerce.
104.
"Shellstock" means raw,
in-shell MOLLUSCAN SHELLFISH.
105.
"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; E. coli O157: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.
106.
"Shucked shellfish" means MOLLUSCAN SHELLFISH that have one or
both shells removed.
107.
"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.
108.
Single-Use Articles.
(i)
"Single-use articles" means
UTENSILS and bulk FOOD containers designed and constructed to be used once and
discarded.
(ii)
"Single-use
articles" includes items such as wax paper, butcher paper, plastic wrap,
formed aluminum FOOD containers, jars, plastic tubs or buckets, bread wrappers,
pickle barrels, ketchup bottles, and number 10 cans which do not meet the
materials, durability, strength, and cleanability specifications under
40-7-1-.16(1),
40-7-1-.17(1), and
40-7-1-.17(3) for
multiuse UTENSILS.
109.
"Slacking" means the process of moderating the temperature of a
FOOD such as allowing a FOOD to gradually increase from a temperature of
-23°C (-10°F) to -4°C (25°F) in preparation for deep-fat frying
or to facilitate even heat penetration during the cooking of previously
block-frozen FOOD such as shrimp.
110.
"Smooth" means:
(i) A FOOD-CONTACT SURFACE having a surface
free of pits and inclusions with a cleanability equal to or exceeding that of
100 grit or number 3 stainless steel;
(ii) A nonFOOD-CONTACT SURFACE of EQUIPMENT
having a surface equal to that of commercial grade hot-rolled steel free of
visible scale; and
(iii) A floor,
wall, or ceiling having an even or level surface with no roughness or
projections that render it difficult to clean.
111.
"Tableware" means eating,
drinking, and serving UTENSILS for table use such as flatware including forks,
knives, and spoons; hollowware including bowls, cups, serving dishes, and
tumblers; and plates.
112.
"Temperature measuring device" means a thermometer, thermocouple,
thermistor, or other device that indicates the temperature of FOOD, air, or
water.
113.
Time/Temperature
Control for Safety Food - formerly "potentially hazardous food" (PHF).
(i)
"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.
(ii)
"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 Subparagraph (iii)(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:
> 4.6 - 5.6
|
PH:
> 5.6
|
<0.92
|
non-TCS FOOD*
|
non-TCS FOOD
|
non-TCS FOOD
|
> 0.92 - 0.95
|
non-TCS FOOD
|
non-TCS FOOD
|
PA**
|
> 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 heat-treated or heat-treated but not PACKAGED
AW
values
|
PH:
< 4.2
|
PH:
4.2 - 4.6
|
PH:
> 4.6 - 5.0
|
PH:
> 5.0
|
< 0.88
|
non-TCS food*
|
non-TCS food
|
non-TCS food
|
non-TCS food
|
0.88 - 0.90
|
non-TCS food
|
non-TCS food
|
non-TCS food
|
PA**
|
> 0.90 - 0.92
|
non-TCS food
|
non-TCS food
|
PA
|
PA
|
> 0.92
|
non-TCS food
|
PA
|
PA
|
PA
|
* TCS FOOD means TIME/TEMPERATURE CONTROL FOR SAFETY
FOOD
** PA means Product Assessment required
(iii)
"Time/temperature control for safety food"
does not include:
(I)
An air-cooled hard-boiled EGG with shell intact, or an EGG with shell
intact that is not hard-boiled, but has been pasteurized to destroy all viable
salmonellae;
(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 as
Product Assessment Required (PA) 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:
I.
Intrinsic factors including added or natural characteristics of the
FOOD such as preservatives, antimicrobials, humectants, acidulants, or
nutrients,
II.
Extrinsic factors including environmental or operational factors that
affect the FOOD such as packaging, modified atmosphere such as REDUCED OXYGEN
PACKAGING, shelf life and use, or temperature range of storage and use,
or
III.
A
combination of intrinsic 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 Subparagraphs (iii)(I) - (iii)(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.
114.
"USDA" means the U.S.
Department of Agriculture.
115.
"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.
116.
"Variance" means a written document issued by the DEPARTMENT that
authorizes a modification or waiver of one or more requirements of these
Regulations if, in the opinion of the DEPARTMENT, a health HAZARD or nuisance
will not result from the modification or waiver.
117.
"Vending machine" means a
self-service device that, upon insertion of a coin, paper currency, token,
card, or key, or by electronic transaction or optional manual operation,
dispenses unit servings of FOOD in bulk or in packages without the necessity of
replenishing the device between each vending operation.
118.
"Vending machine location"
means the room, enclosure, space, or area where one or more VENDING MACHINES
are installed and operated and includes the storage areas and areas on the
PREMISES that are used to service and maintain the VENDING MACHINES.
119.
"Warewashing" means the
cleaning and SANITIZING of UTENSILS and FOOD-CONTACT SURFACES of
EQUIPMENT.
120.
"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.