FDA 1997 Food Code - Chapter 1: Purpose and Definitions
U. S. Department of Health and Human Services
Public Health Service
Food and Drug Administration
1997 Food Code
1-101.10 Food Code.
These provisions shall be known as the Food Code, hereinafter referred to as "this Code."
1-102.10 Food Safety, Illness Prevention, and Honest Presentation.
The purpose of this Code is to safeguard public health and provide to consumers food that is safe, unadulterated, and honestly presented.
This Code establishes definitions; sets standards for management and personnel, food operations, and equipment and facilities; and provides for food establishment plan review, permit issuance, inspection, employee restriction, and permit suspension.
Applicability and Terms Defined
1-201.10 Statement of Application and Listing of Terms.
(A) The following definitions apply in the interpretation and application of this Code.
(B) Terms Defined.
(a) "Food additive" has the meaning stated in the Federal Food, Drug, and Cosmetic Act, § 201(s) and 21 CFR 170.
(b) "Color additive" has the meaning stated in the Federal Food, Drug, and Cosmetic Act, § 201(t) and 21 CFR 70.
(2) "Adulterated" has the meaning stated in the Federal Food, Drug, and Cosmetic Act, § 402.
(3) "Approved" means acceptable to the regulatory authority based on a determination of conformity with principles, practices, and generally recognized standards that protect public health.
(4) "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.
(5) "Beverage" means a liquid for drinking, including water.
(6) "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.
(7) "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.
(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.
(9) "CFR" means Code of Federal Regulations. Citations in this Code 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.
(10) "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:
(a) Is published annually by the U.S. Government Printing Office; and
(b) 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.
(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 2 or more types of meat that have been reduced in size and combined, such as sausages made from 2 or more meats.
(12) "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.
(13) "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.
(14) "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.
(15) "Critical control point" means a point or procedure in a specific food system where loss of control may result in an unacceptable health risk.
(16) Critical Item.
(a) "Critical item" means a provision of this Code, that, if in noncompliance, is more likely than other violations to contribute to food contamination, illness, or environmental health hazard.
(b) "Critical item" is an item that is denoted in this Code with an asterisk *.
(17) "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.
(18) Drinking Water.
(a) "Drinking water" means water that meets 40 CFR 141 National Primary Drinking Water Regulations.
(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.
(19) "Dry storage area" means a room or area designated for the storage of packaged or containerized bulk food that is not potentially hazardous and dry goods such as single-service items.
(20) 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 under Subparagraph (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.
(21) "Easily movable" means:
(a) Weighing 14 kg (30 pounds) or less; mounted on casters, gliders, or rollers; or provided with a mechanical means requiring no more than 14 kg (30 pounds) of force 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.
(22) "Employee" means the permit 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 a food establishment.
(23) "EPA" means the U.S. Environmental Protection Agency.
(a) "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.
(b) "Equipment" 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.
(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.
(26) "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.
(27) Foodborne Disease Outbreak.
(a) "Foodborne disease outbreak" means an incident, except as specified under Subparagraph (b) of this definition, in which:
(i) 2 or more persons experience a similar illness after ingestion of a common food; and
(ii) Epidemiological analysis implicates the food as the source of the illness.
(b) "Foodborne disease outbreak" includes a single case of illness such as 1 person ill from botulism or chemical poisoning.
(28) "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.
(29) "Food employee" means an individual working with unpackaged food, food equipment or utensils, or food-contact surfaces.
(30) Food Establishment.
(a) "Food establishment" means an operation that stores, prepares, packages, serves, vends, or otherwise provides food for human consumption:
(i) Such as a restaurant; satellite or catered feeding location; catering operation if the operation provides food directly to a consumer or to a conveyance used to transport people; market; vending location; conveyance used to transport people; institution; or food bank; and
(ii) That relinquishes possession of food to a consumer directly, or indirectly through a delivery service such as home delivery of grocery orders or restaurant takeout orders, or delivery service that is provided by common carriers.
(b) "Food establishment" includes:
(i) An element of the operation such as a transportation vehicle or a central preparation facility that supplies a vending location or satellite feeding location unless the vending or feeding location is permitted by the regulatory authority; and
(ii) An operation that is conducted in a mobile, stationary, temporary, or permanent facility or location; where consumption is on or off the premises; and regardless of whether there is a charge for the food.
(c) "Food establishment" does not include:
(i) An establishment that offers only prepackaged foods that are not potentially hazardous;
(ii) A produce stand that only offers whole, uncut fresh fruits and vegetables;
(iii) A food processing plant;
(iv) A kitchen in a private home if only food that is not potentially hazardous is prepared for sale or service at a function such as a religious or charitable organization's bake sale if allowed by law and if the consumer is informed by a clearly visible placard at the sales or service location that the food is prepared in a kitchen that is not subject to regulation and inspection by the regulatory authority;
(v) An area where food that is prepared as specified in Subparagraph (c)(iv) of this definition is sold or offered for human consumption;
(vi) A kitchen in a private home, such as a small family day-care provider; or a bed-and-breakfast operation that prepares and offers food to guests if the home is owner occupied, the number of available guest bedrooms does not exceed 6, breakfast is the only meal offered, the number of guests served does not exceed 18, and the consumer is informed by statements contained in published advertisements, mailed brochures, and placards posted at the registration area that the food is prepared in a kitchen that is not regulated and inspected by the regulatory authority; or
(vii) A private home that receives catered or home-delivered food.
(31) Food Processing Plant.
(a) "Food processing plant" means a commercial operation that manufactures, packages, labels, or stores food for human consumption and does not provide food directly to a consumer.
(b) "Food processing plant" does not include a food establishment as defined under Subparagraph 1-201.10(B)(30).
(32) Game Animal.
(a) "Game animal" means an animal, the products of which are food, that is not classified as cattle, sheep, swine, goat, horse, mule, or other equine in 9 CFR Subchapter A - Mandatory Meat Inspection, Part 301, as Poultry in 9 CFR Subchapter C - Mandatory Poultry Products Inspection, Part 381, or as fish as defined under Subparagraph 1-201.10(B)(25).
(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 such as ostrich, emu, and rhea.
(33) "Grade A standards" means the requirements of the United States Public Health Service/FDA "Grade A Pasteurized Milk Ordinance" and "Grade A Condensed and Dry Milk Ordinance" with which certain fluid and dry milk and milk products comply.
(34) "General use pesticide" means a pesticide that is not classified by EPA for restricted use as specified in 40 CFR 152.175.
(35) Group Residence.
(a) "Group residence" means a private or public housing corporation or institutional facility that provides living quarters and meals.
(b) "Group residence" includes a domicile for unrelated persons such as a retirement home or a long-term health care facility.
(36) "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.
(37) "Hazard" means a biological, chemical, or physical property that may cause an unacceptable consumer health risk.
(38) "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.
(39) "Highly susceptible population" means a group of persons who are more likely than other populations to experience foodborne disease because they are immunocompromised or older adults and in a facility that provides health care or assisted living services, such as a hospital or nursing home; or preschool age children in a facility that provides custodial care, such as a day care center.
(40) "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.
(41) "Injected" means manipulating a meat so that infectious or toxigenic microoganisms may be introduced from its surface to its interior through tenderizing with deep penetration or injecting the meat such as with juices which may be referred to as "injecting," "pinning," or "stitch pumping."
(42) "Kitchenware" means food preparation and storage utensils.
(43) "Law" means applicable local, state, and federal statutes, regulations, and ordinances.
(44) "Linens" means fabric items such as cloth hampers, cloth napkins, table cloths, wiping cloths, and work garments including cloth gloves.
(45) "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 3-201.17(A)(3) and (4).
(46) "mg/L" means milligrams per liter, which is the metric equivalent of parts per million (ppm).
(47) "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.
(a) "Packaged" means bottled, canned, cartoned, securely bagged, or securely wrapped, whether packaged in a food establishment or a food processing plant.
(b) "Packaged" does not include a wrapper, carry-out box, or other nondurable container used to containerize food with the purpose of facilitating food protection during service and receipt of the food by the consumer.
(49) "Permit" means the document issued by the regulatory authority that authorizes a person to operate a food establishment.
(50) "Permit holder" means the entity that:
(a) Is legally responsible for the operation of the food establishment such as the owner, the owner's agent, or other person; and
(b) Possesses a valid permit to operate a food establishment.
(51) "Person" means an association, a corporation, individual, partnership, other legal entity, government, or governmental subdivision or agency.
(52) "Person in charge" means the individual present at a food establishment who is responsible for the operation at the time of inspection.
(53) 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; and other items such as cosmetics, and toiletries such as toothpaste and mouthwash.
(54) "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.
(55) "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.
(56) "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.
(57) "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.
(58) "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.
(59) Potentially Hazardous Food.
(a) "Potentially hazardous food" means a food that is natural or synthetic and that requires temperature control because it is in a form capable of supporting:
(i) The rapid and progressive growth of infectious or toxigenic microorganisms;
(ii) The growth and toxin production of Clostridium botulinum; or
(iii) In raw shell eggs, the growth of Salmonella enteritidis.
(b) "Potentially hazardous food" includes an animal food (a food of animal origin) that is raw or heat-treated; a food of plant origin that is heat-treated or consists of raw seed sprouts; cut melons; and garlic and oil mixtures that are not acidified or otherwise modified at a food processing plant in a way that results in mixtures that do not support growth as specified under Subparagraph (a) of this definition.
(c) "Potentially hazardous food" does not include:
(i) An air-cooled hard-boiled egg with shell intact;
(ii) A food with an aw value of 0.85 or less;
(iii) A food with a pH level of 4.6 or below when measured at 24oC (75oF);
(iv) A food, in an unopened hermetically sealed container, that is commercially processed to achieve and maintain commercial sterility under conditions of nonrefrigerated storage and distribution; and
(v) A food for which laboratory evidence demonstrates that the rapid and progressive growth of infectious or toxigenic microorganisms or the growth of S. enteritidis in eggs or C. botulinum can not occur, such as a food that has an aw and a pH that are above the levels specified under Subparagraphs (c)(ii) and (iii) of this definition and that may contain a preservative, other barrier to the growth of microorganisms, or a combination of barriers that inhibit the growth of microorganisms.
(vi) A food that does not support the growth of microorganisms as specified under Subparagraph (a) of this definition even though the food may contain an infectious or toxigenic microorganism or chemical or physical contaminant at a level sufficient to cause illness.
(a) "Poultry" means:
(i) Any domesticated bird (chickens, turkeys, ducks, geese, or guineas), whether live or dead, as defined in 9 CFR 381 Poultry Products Inspection Regulations; and
(ii) Any migratory waterfowl, game bird, or squab such as pheasant, partridge, quail, grouse, or guineas, whether live or dead, as defined in 9 CFR 362 Voluntary Poultry Inspection Program.
(b) "Poultry" does not include ratites.
(61) "Premises" means:
(a) The physical facility, its contents, and the contiguous land or property under the control of the permit holder; or
(b) The physical facility, its contents, and the land or property not described under Subparagraph (a) of this definition if its facilities and contents are under the control of the permit holder and may impact food establishment personnel, facilities, or operations, if a food establishment is only one component of a larger operation such as a health care facility, hotel, motel, school, recreational camp, or prison.
(62) "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.
(63) "Public water system" has the meaning stated in 40 CFR 141 National Primary Drinking Water Regulations.
(64) Ready-to-Eat Food.
(a) "Ready-to-eat food" means food that is in a form that is edible without washing, cooking, or additional preparation by the food establishment or the consumer and that is reasonably expected to be consumed in that form.
(b) "Ready-to-eat food" includes:
(i) Potentially hazardous food that is unpackaged and cooked to the temperature and time required for the specific food under Subpart 3-401;
(ii) Raw, washed, cut fruits and vegetables;
(iii) Whole, raw, fruits and vegetables that are presented for consumption without the need for further washing, such as at a buffet; and
(iv) Other food presented for consumption for which further washing or cooking is not required and from which rinds, peels, husks, or shells are removed.
(65) Reduced Oxygen Packaging.
(a) "Reduced oxygen packaging" means the reduction of the amount of oxygen in a package by mechanically evacuating the oxygen; displacing the oxygen with another gas or combination of gases; or otherwise controlling the oxygen content in a package to a level below that normally found in the surrounding atmosphere, which is 21% oxygen.
(b) "Reduced oxygen packaging" includes methods that may be referred to as altered atmosphere, modified atmosphere, controlled atmosphere, low oxygen, and vacuum packaging including sous vide.
(66) "Refuse" means solid waste not carried by water through the sewage system.
(67) "Regulatory authority" means the local, state, or federal enforcement body or authorized representative having jurisdiction over the food establishment.
(68) "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.
(69) "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 or 706 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.
(70) "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.
(71) "Sealed" means free of cracks or other openings that allow the entry or passage of moisture.
(72) "Servicing area" means an operating base location to which a mobile food establishment or transportation vehicle returns regularly for such things as discharging liquid or solid wastes, refilling water tanks and ice bins, and boarding food.
(73) "Sewage" means liquid waste containing animal or vegetable matter in suspension or solution and may include liquids containing chemicals in solution.
(74) "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.
(75) "Shellstock" means raw, in-shell molluscan shellfish.
(76) "Shucked shellfish" means molluscan shellfish that have one or both shells removed.
(77) "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.
(78) 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" 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 §§ 4-101.11, 4-201.11, and 4-202.11 for multiuse utensils.
(79) "Slacking" means the process of moderating the temperature of a food such as allowing a food to gradually increase from a temperature of -23oC (-10oF) to -4o C (25oF) in preparation for deep-fat frying or to facilitate even heat penetration during the cooking of previously block-frozen food such as spinach.
(80) "Smooth" means:
(a) A food-contact surface having a surface free of pits and inclusions with a cleanability equal to or exceeding that of (100 grit) number 3 stainless steel;
(b) A nonfood-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 render it difficult to clean.
(81) "Support animal" means a trained animal such as a Seeing Eye dog that accompanies a person with a disability to assist in managing the disability and enables the person to perform functions that the person would otherwise be unable to perform.
(82) "Table-mounted equipment" means equipment that is not portable and is designed to be mounted off the floor on a table, counter, or shelf.
(83) "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.
(84) "Temperature measuring device" means a thermometer, thermocouple, thermistor, or other device that indicates the temperature of food, air, or water.
(85) "Temporary food establishment" means a food establishment that operates for a period of no more than 14 consecutive days in conjunction with a single event or celebration.
(86) "USDA" means the U.S. Department of Agriculture.
(87) "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; and food temperature measuring devices.
(88) "Vending machine" means a self-service device that, upon insertion of a coin, paper currency, token, card, or key, dispenses unit servings of food in bulk or in packages without the necessity of replenishing the device between each vending operation.
(89) "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.
(90) "Warewashing" means the cleaning and sanitizing of food-contact surfaces of equipment and utensils.