Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 260 - Good Manufacturing Practice Regulations › Subchapter 1 - General Provisions › Section 310:260-1-6 - Definitions

Current through Vol. 41, No. 20, July 1, 2024
The following words or terms, when used in this chapter,
				  shall have the following meaning, unless the context clearly indicates
				  otherwise:
"Acid food or acidified food"
means foods that
				  have an equilibrium pH of 4.6 or below.
"Additive"
means as used in this Chapter the
				  following terms:
(A)
"Color additive"
means as stated in the
				  Federal Food, Drug, and Cosmetic Act,
				  21 U.S.C. Section
				  321(t) and
				  21
				  CFR, Part 70.
(B)
"Food additive"
means as stated in the
				  Federal Food, Drug, and Cosmetic Act,
				  21 U.S.C. Section
				  321(s) and
				  21
				  CFR, Part 170.
"Adequate"
means that which is needed to
				  accomplish the intended purpose in keeping with good public health practice.
"Adulterated"
means the definition in 63 O.S.
				  Section 1-1109.
"Approved"
means acceptable to the Department
				  based on a determination of conformity with principles, practices, and
				  generally recognized standards that protect public health.
"Batter"
means a semi-fluid substance, usually
				  composed of flour and other ingredients, into which principal components of
				  food are dipped or with which they are coated, or which may be used directly to
				  form bakery foods.
"Beverage"
means a liquid for drinking,
				  including water.
"Bin warehouse"
means any building where
				  pre-packaged food is stored, the operator or his employee is present no more
				  than two hours daily, and no other operations are conducted.
"Blanching"
, except for tree nuts and peanuts,
				  means a prepackaging heat treatment of food stuffs for a sufficient time and at
				  a sufficient temperature to partially or completely inactivate the naturally
				  occurring enzymes and to effect other physical or bio-chemical changes in food.
"CFR"
means Code of Federal Regulations.
				  Citations in this Chapter to the CFR refer sequentially to the Title, Part, and
				  Section numbers, such as
				  21 CFR,
				  178.1010 refers to Title 21, Part 178,
				  Section 1010.
"Code of Federal Regulations"
means the
				  compilation of the general and permanent rules published in the Federal
				  Register by the executive departments and agencies of the federal government
				  which is published annually by the U.S. Government Printing Office; and
				  contains FDA rules in 21 CFR, USDA rules in 7 CFR and 9 CFR, EPA rules in 40
				  CFR, and Wildlife and Fisheries rules in 50 CFR.
"Control measure"
means any action or activity
				  to prevent, reduce to acceptable levels, or eliminate a hazard.
"Corrosion-resistant"
means capable of
				  maintaining original surface characteristics under prolonged influence of the
				  food to be contacted, the normal use of cleaning compounds and bactericidal
				  solutions, and other conditions-of-use.
"Critical control point"
means a point or
				  procedure in a specific food process at which a control measure can be applied
				  and at which control is essential to reduce an identified food hazard to an
				  acceptable level.
"Custom tree nut cracking"
means the cracking of
				  whole tree nuts for individual customers. The tree nuts may be brought by the
				  customer from off the premises or may be purchased from the cracker. Tree nuts
				  may not be cracked for resale.
"Department"
means the Oklahoma State Department
				  of Health, its duly designated representatives, and a health department
				  designated in writing by the State Commissioner of Health to perform official
				  duties or other acts authorized under the Oklahoma Public Health Code and this
				  Chapter.
"Distressed merchandise"
means any food which
				  has been subjected to improper storage; loss of label or identity; smoke,
				  water, fumes, extreme temperatures, pressure or radiation which are due to
				  natural disasters or otherwise; or which may have been rendered unsafe or
				  unsuitable for human or animal consumption or use for any other reason.
"Easily cleanable"
means that surfaces are
				  readily accessible and made of such materials and finish and so fabricated that
				  residue may be effectively removed by normal cleaning methods.
"Employee"
means the license holder, person in
				  charge, person having supervisory or management duties, person on the payroll,
				  family member, volunteer, person performing work under contractual agreement,
				  or other person working in an establishment.
"Equipment"
means an article that is used in the
				  operation of an 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. It does not include items 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.
"Food"
means any 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.
"Food contact surfaces"
means those surfaces of
				  equipment and utensils with which food normally comes in contact, and those
				  surfaces from which food may contact drain, drip, or splash back onto surfaces
				  normally in contact with food.
"Food hazard"
means any biological, chemical, or
				  physical agent that is reasonably likely to cause illness or injury in the
				  absence of its control.
"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.
"Food storage warehouse"
means any building,
				  establishment or place where food is stored as a commercial venture or
				  business, or is stored in connection with or as a part of a business.
"HACCP"
means Hazard Analysis Critical Control
				  Point.
"HACCP plan"
means a written document that
				  delineates the formal procedures for following the Hazard Analysis Critical
				  Control Point principles developed by The National Advisory Committee on
				  Microbiological Criteria for Foods.
"Handwashing sink"
means a lavatory, a basin or
				  vessel for washing, a wash basin, or a plumbing fixture especially placed for
				  use in personal hygiene and designed for washing of the hands.
"Hazardous substance"
means any substance or
				  mixture of substances which is toxic, corrosive, an irritant, strong sanitizer,
				  flammable or which generates pressure through decomposition.
"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.
"Imminent public health hazard"
means
				  asignificant 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 the number of potential injuries, and the
				  nature, severity, and duration of the anticipated injury.
"Impermeable"
means incapable of allowing
				  liquids to pass through the covering.
"License"
means the document issued by the
				  Department that authorizes a person to operate an establishment.
"License holder"
means the entity that is
				  legally responsible for the operation of the establishment such as the owner,
				  the owner's agent, or other person; and possesses a valid license to operate an
				  establishment.
"Lot"
means the food produced during a period of
				  time indicated by a specific code.
"Major food allergen"
means milk, egg, fish
				  (such as bass, flounder, cod, and including crustacean such as crab, lobster,
				  or shrimp), tree nuts (such as almonds, pecans, or walnuts), wheat, peanuts,
				  and soybeans; or a food ingredient that contains protein derived from a food
				  specified above.
(A) Major food allergen does not include: Any highly refined
				  oil derived from a food specified in Major Food Allergen definition and any
				  ingredient derived from such highly refined oil; or
(B) Any ingredient that is exempt under the petition or
				  notification process specified in the Federal Food, Drugs, and Cosmetics Act,
				  21 U.S.C. Section
				  343.
"Manufacture"
means the process of combining or
				  purifying articles of food and packing same for sale to the consumer, either by
				  wholesale or retail. Any firm, person, or corporation who represents itself as
				  responsible for the purity and the proper labeling of any article of food by
				  placing or having placed its name and address on the label of any food shall be
				  deemed a manufacturer and shall be included within the meaning of these rules.
"Microorganism"
means yeasts, molds, bacteria
				  and viruses and includes, but is not limited to, species having public health
				  significance. The term "undesirable microorganisms" includes those
				  microorganisms that are of public health significance, that subject food to
				  decomposition, that indicate that food is contaminated with filth, or that
				  otherwise may cause food to be adulterated.
"Misbranding"
means the definition contained in
				  63 O.S. Section 1-1110.
"Monitor"
means to conduct a planned sequence of
				  observations or measurements to assess whether a process, point, or procedure
				  is under control and to produce an accurate record for use in verification.
"Non-food contact surfaces"
means surfaces of
				  equipment not intended for contact with food, but which are being exposed to
				  splash or food debris or which otherwise require frequent cleaning. These
				  surfaces shall be designed and fabricated to be smooth, washable, free of
				  unnecessary ledges, projections, or crevices, readily accessible for cleaning,
				  and shall be of such material and in such repair as to be easily maintained in
				  a clean and sanitary condition.
Non-salvageable merchandise"
means distressed
				  merchandise which cannot be safely or practically reconditioned.
"Packaging"
means any covering, wrapper, or
				  container in which a product is placed for retail or wholesale distribution,
				  either before or after sale, to a consumer. Packaging shall not be construed to
				  include the inner wrapper.
"Perishable foods"
means any food of such type
				  or in such condition or physical state that it may spoil or otherwise become
				  unfit for human consumption.
"Person"
means an individual, corporation,
				  business trust, estate, trust, partnership, association, or any other public or
				  private legal entity.
"Personnel"
means all persons employed by a food
				  manufacturer, salvage establishment or salvage broker who do or may in any
				  manner handle or come in contact with the handling, storage, transporting,
				  selling or distributing of food, salvageable or salvaged merchandise.
"Pest"
means any objectionable animal or insect
				  including, but not limited to, birds, rodents, flies and larvae.
"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.
Plant"
means the building or facility or parts
				  thereof, used for or in connection with the manufacturing, packaging, labeling
				  or holding of human food.
"Plumbing fixture"
means a receptacle or device
				  that is permanently or temporarily connected to the water distribution system
				  of the premises and demands a supply of water from the system; or discharges
				  used water, waste materials, or sewage directly or indirectly to the drainage
				  system of the premises.
"Plumbing system"
means the water supply and
				  distribution pipes; plumbing fixtures and traps; soil, waste, and vent pipes;
				  sanitary and storm sewers and building drains, including their respective
				  connections, devices, and appurtenances within the premises; and water-treating
				  equipment.
"Poisonous or toxic materials"
means substances
				  that are not intended for ingestion and are included in 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 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 establishment and are on the premises for retail sale, such
				  as petroleum products and paints.
"Potable water"
means water obtained from an
				  approved source that is:
(A) A public water system, or
(B) A nonpublic water system that is constructed, maintained,
				  and operated according to law.
"Processing"
means the preparing of a food in a
				  manner which changes the food from its original state.
"Processor"
means anyone processing food under
				  the authority of this chapter.
"Quality control operation"
means a planned and
				  systematic procedure for taking all actions necessary to prevent food from
				  being adulterated.
"Reconditioning"
means any appropriate process
				  or procedure by which distressed merchandise can be brought into compliance
				  with the standards of the Department for consumption or use by the public.
"Refuse"
means all garbage, trash, and rubbish
				  not intended for reuse as salvaged merchandise.
"Regulatory authority"
means the Oklahoma State
				  Department of Health, a health department designated in writing by the State
				  Commissioner of Health to perform official duties or other acts authorized
				  under the Oklahoma Public Health Code and this Chapter, or a representative
				  thereof.
"Rework"
means clean, unadulterated food that
				  has been removed from processing for reasons other than unsanitary conditions
				  or that has been successfully reconditioned by reprocessing and that is
				  suitable for use as food.
"Safe moisture level"
is a level of moisture low
				  enough to prevent the growth of undesirable microorganisms in the finished
				  product under the intended conditions of manufacturing, storage and
				  distribution. The maximum safe moisture level for a food is based on its water
				  activity (a W). An a W will be considered safe for a food if adequate data are
				  available that demonstrate that the food at or below the given aw will not
				  support the growth of undesirable microorganisms.
"Safe temperatures"
as applied to
				  Time/Temperature Control for Safety Food means food temperature of 45°F or
				  below 140°F or above.
"Sale or distribution"
means the act of selling
				  or distributing, whether for compensation or not, and includes delivery,
				  holding or offering for sale, transfer, or other means of handling or
				  trafficking.
"Salvage distributor or broker"
means a person
				  who engages in the business of selling, distributing, or otherwise trafficking
				  in any distressed or salvaged merchandise who does not operate a salvage
				  establishment.
"Salvage establishment"
means any place of
				  business engaged in reconditioning or by other means the salvaging of
				  distressed merchandise or that sells, buys or distributes for human use any
				  salvaged merchandise.
"Salvage operator"
means a person who is engaged
				  in the business of operating a salvage establishment.
"Salvage processing plant"
means any
				  establishment primarily engaged in the business of reconditioning or by other
				  means the salvaging of distressed merchandise and which sells or distributes
				  such merchandise for human use.
"Salvage warehouse"
means a separate storage
				  facility used by a salvage broker or salvage establishment for the purpose of
				  holding distressed or salvaged merchandise. A salvage warehouse may not be used
				  for the purpose of reconditioning or selling to consumers.
"Salvageable merchandise"
means any distressed
				  merchandise, as defined in this section, which can be reconditioned to the
				  satisfaction of the Department.
"Salvaged merchandise"
means any distressed
				  merchandise that has been reconditioned to the satisfaction of the Department.
" Sanitize "
means to adequately treat
				  food-contact by a process that is effective in destroying vegetative cells of
				  microorganisms of public health significance and in substantially reducing the
				  number of other microorganisms but without adversely affecting the product or
				  its safety to the consumer.
"Shall"
is used to state mandatory requirements.
"Shelf-stable product"
means a product that is
				  hermetically sealed and, when stored at room temperature, should not
				  demonstrate any microbial growth.
"Should"
is used to state recommended or
				  advisory procedures or to identify recommended equipment.
"Single-service articles"
means cups,
				  containers, lids, closures, plates, knives, forks, spoons, stirrers, paddles,
				  straws, placemats, napkins, doilies, wrapping materials, toothpicks and similar
				  articles, intended to be discarded after one use.
"Standard operating procedure (SOP)"
means a set
				  of step-by-step instructions compiled by the establishment to instruct
				  employees in the proper method to perform complex routine operations. SOPs aim
				  to achieve efficiency and quality control, while reducing miscommunication, and
				  documenting failure to enable better process to be developed.
"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.
"Tree nut cracker/sheller"
means a commercial
				  establishment in which tree nuts are processed and/or packaged for human
				  consumption, other than custom tree nut cracking.
"Tree nut grower"
means a person who sells only
				  whole tree nuts grown on his property.
"Utensil"
means any implement used in the
				  storage, preparation, transportation, or service of food.
"Variance"
means a written document issued by
				  the Department that authorizes a modification or waiver of one or more
				  requirements of this Chapter, if, in the opinion of the Department, a health
				  hazard or nuisance will not result from the modification or waiver.
"Vehicle"
means any car, truck, bus or other
				  means by which food or distressed, salvageable or salvaged merchandise is
				  transported from one location to another.
"Water activity"
(a W) is a measure of the free
				  moisture in a food and is the quotient of the water vapor pressure of the
				  substance divided by the vapor pressure of pure water at the same temperature.
"Wholesome"
means in sound condition, clean,
				  free from adulteration and otherwise suitable for human consumption.
Amended at 8 Ok Reg
				  3099, eff 7-18-91 (emergency); Amended at 9 Ok Reg 1491, eff
				  5-1-92