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Oklahoma Administrative Code (Last Updated: March 11, 2021) |
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TITLE 310. Oklahoma State Department of Health |
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Chapter 260. Good Manufacturing Practice Regulations |
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Subchapter 1. General Provisions |
SECTION 310:260-1-6. Definitions
Latest version.
- 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 nutcracking" 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 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 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 (aW). An aW 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 Foodmeans 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" (aW) 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.