Acid foods or acidified foods – Foods that have an equilibrium pH of 4.6 or below. (NOTE: acid foods have a natural pH of 4.6 or below; acidified foods have acid added to reduce the pH.)
Adequate – That which is needed to accomplish the intended purpose in keeping with good public health practice.
Affiliate – Any facility that controls, is controlled by, or is under common control with another facility.
Allergen cross-contact – The unintentional incorporation of a food allergen into a food.
Audit – The systematic, independent, and documented examination (through observation, investigation, records review, discussions with employees of the audited entity, and, as appropriate, sampling and laboratory analysis) to assess a supplier’s food safety processes and procedures.
aW (Water Activity) – 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.
Batter – Semifluid 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.
Blanching – Except for tree nuts and peanuts, means a prepackaging heat treatment of foodstuffs for an adequate time and at an adequate temperature to partially or completely inactivate the naturally occurring enzymes and to effect other physical or biochemical changes in the food.
Calendar day – Every day shown on the calendar.
cGMPs – Current Good Manufacturing Practices. The regulation (117 Subpart that outlines the conditions and practices the regulated food industry must follow for processing safe food under sanitary conditions, including personnel, plant and grounds, sanitary operations, sanitary facilities and controls, equipment and utensils, processes and controls, warehousing and distribution, and defect action levels considerations.
Cleaning – The removal of soil, food residue, dirt, grease or other objectionable matter.
Correction – An action to identify and correct a problem that occurred during the production of food, without other actions associated with a corrective action procedure (such as actions to reduce the likelihood that the problem will recur, evaluate all affected food for safety, and prevent affected food from entering commerce).
Corrective action – Procedures that must be taken if preventive controls are not properly implemented.
Critical Control Point (CCP) – A point, step, or procedure in a food process at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce such hazard to an acceptable level.
Critical limit – The maximum or minimum value, or combination of values, to which any biological, chemical or physical parameter must be controlled to significantly minimize or prevent a hazard requiring a process preventive control.
Cross-contact – The unintentional incorporation of a food allergen into a food.
Cross-contamination – Unintentional transfer of a pathogen from a food or surface to another food or surface.
Defect action level – A level of a non-hazardous, naturally occurring, unavoidable defect at which FDA may regard a food product “adulterated” and subject to enforcement action under section 402(a)(3) of the Federal Food, Drug, and Cosmetic Act.
Deviation – Failure to meet a critical limit.
Environmental pathogen – A pathogen capable of surviving and persisting within the manufacturing, processing, packing or holding environment such that food may be contaminated and may result in foodborne illness if that food is consumed without treatment to significantly minimize the environmental pathogen. Examples of environmental pathogens for the purposes of this part include Listeria monocytogenes and Salmonella spp. but do not include the spores of pathogenic spore-forming bacteria.
Facility – A domestic facility or foreign facility that is required to register under section 415 of the Federal Food, Drug, and Cosmetic Act, in accordance with the requirements of 21 CFR part 1, subpart H.
Food – Includes (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article. Examples of food include fruits, vegetables, fish, dairy products, eggs, raw agricultural commodities used for food or as components of food, animal feed (including pet food), food and feed ingredients, food and feed additives, dietary supplements and dietary ingredients, infant formula, beverages (including alcoholic beverages and bottled water), live food animals, bakery goods, snack foods, candy, and canned foods. Does not include pesticides or food contact substances not intended to have any technical effect in the food.
Food allergen – Any of the following: (1) Milk, egg, fish (e.g., bass, flounder or cod), Crustacean shellfish (e.g., crab, lobster or shrimp), tree nuts (e.g., almonds, pecans or walnuts), wheat, peanuts, and soybeans. (2) A food ingredient that contains protein derived from a food specified in paragraph (1), except any highly refined oil derived from a food specified in paragraph (1) and any ingredient derived from such highly refined oil.
Food-contact surface – Those surfaces that contact human food and those surfaces from which drainage, or other transfer, onto the food or onto surfaces that contact the food ordinarily occurs during the normal course of operation. “Food contact surfaces” includes utensils and food-contact surfaces of equipment.
Food Safety Plan – A set of written documents that is based on food safety principles; incorporates hazard analysis, preventive controls, supply-chain programs, and a recall plan; and delineates the procedures to be followed for monitoring, corrective actions and verification.
Food safety system – The outcome of implementing the Food Safety Plan and its supporting elements.
Full-time equivalent employee – A term used to represent the number of employees of a business entity for the purpose of determining whether the business qualifies for the small business exemption. The number of full-time equivalent employees is determined by dividing the total number of hours of salary or wages paid directly to employees of the business entity and of all of its affiliates and subsidiaries by the number of hours of work in 1 year, 2,080 hours (i.e., 40 hours x 52 weeks). If the result is not a whole number, round down to the next lowest whole number.
GMPs (Good Manufacturing Practices) – The regulation (117 Subpart that outlines the conditions and practices the regulated food industry must follow for processing safe food under sanitary conditions, including personnel, plant and grounds, sanitary operations, sanitary facilities and controls, equipment and utensils, processes and controls, warehousing and distribution, and defect action levels considerations.
Harvesting – Applies to farms and farm mixed-type facilities and means activities that are traditionally performed on farms for the purpose of removing raw agricultural commodities from the place they were grown or raised and preparing them for use as food. Harvesting is limited to activities performed on raw agricultural commodities, or on processed foods created by drying/dehydrating a raw agricultural commodity without additional manufacturing/processing, on a farm. Harvesting does not include activities that transform a raw agricultural commodity into a processed food as defined in section 201(gg) of the Federal Food, Drug, and Cosmetic Act. Examples of harvesting include cutting (or otherwise separating) the edible portion of the raw agricultural commodity from the crop plant and removing or trimming part of the raw agricultural commodity (e.g., foliage, husks, roots or stems). Examples of harvesting also include cooling, field coring, filtering, gathering, hulling, removing stems and husks from, shelling, sifting, threshing, trimming of outer leaves of, and washing raw agricultural commodities grown on a farm.
Hazard – Any biological, chemical (including radiological), or physical agent that has the potential to cause illness or injury.
Hazard analysis – The process of collecting and evaluating information on hazards and conditions leading to their presence to decide which are significant for food safety and therefore must be addressed in the HACCP or Food Safety Plan.
Hazard Analysis and Critical Control Point (HACCP) – A system which identifies, evaluates, and controls hazards which are significant for food safety.
Hazard requiring a preventive control – A known or reasonably foreseeable hazard for which a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would, based on the outcome of a hazard analysis (which includes an assessment of the severity of the illness or injury if the hazard were to occur and the probability that the hazard will occur in the absence of preventive controls), establish one or more preventive controls to significantly minimize or prevent the hazard in a food and components to manage those controls (such as monitoring, corrections or corrective actions, verification, and records) as appropriate to the food, the facility, and the nature of the preventive control and its role in the facility’s food safety system.
Holding – Storage of food and also includes activities performed incidental to storage of a food (e.g., activities performed for the safe or effective storage of that food, such as fumigating food during storage, and drying/dehydrating raw agricultural commodities when the drying/dehydrating does not create a distinct commodity (such as drying/dehydrating hay or alfalfa)). Holding also includes activities performed as a practical necessity for the distribution of that food (such as blending of the same raw agricultural commodity and breaking down pallets), but does not include activities that transform a raw agricultural commodity into a processed food as defined in section 201(gg) of the Federal Food, Drug, and Cosmetic Act. Holding facilities could include warehouses, cold storage facilities, storage silos, grain elevators, and liquid storage tanks.
Known or reasonably foreseeable hazard – A biological, chemical (including radiological), or physical hazard that is known to be, or has the potential to be, associated with the facility or the food.
Lot – The food produced during a period of time and identified by an establishment’s specific code.
Manufacturing/processing – Making food from one or more ingredients, or synthesizing, preparing, treating, modifying or manipulating food, including food crops or ingredients. Examples of manufacturing/processing activities include: Baking, boiling, bottling, canning, cooking, cooling, cutting, distilling, drying/dehydrating raw agricultural commodities to create a distinct commodity (such as drying/dehydrating grapes to produce raisins), evaporating, eviscerating, extracting juice, formulating, freezing, grinding, homogenizing, irradiating, labeling, milling, mixing, packaging (including modified atmosphere packaging), pasteurizing, peeling, rendering, treating to manipulate ripening, trimming, washing, or waxing. For farms and farm mixed-type facilities, manufacturing/processing does not include activities that are part of harvesting, packing, or holding.
Microorganisms – Yeast, molds, bacteria, viruses, protozoa and microscopic parasites and includes species that are pathogens. The term “undesirable microorganisms” includes those microorganisms that are pathogens, that subject food to decomposition, that indicates that food is contaminated with filth, or that otherwise may cause food to be adulterated.
Mixed-type facility – An establishment that engages in both activities that are exempt from registration under section 415 of the Federal Food, Drug, and Cosmetic Act and activities that require the establishment to be registered. An example of such a facility is a “farm mixed-type facility,” which is an establishment that is a farm but also conducts activities outside the farm definition that require the establishment to be registered.
Monitor – To conduct a planned sequence of observations or measurements to assess whether control measures are operating as intended.
NACMCF (National Advisory Committee on Microbiological Criteria for Foods) – Chartered under USDA to provide impartial, scientific advice to U.S. Federal food safety agencies for use in the development of an integrated national food safety systems approach from farm to final consumption to assure the safety of domestic, imported, and exported foods.
Non-food-contact surface – Those surfaces that do not contact human food and from which drainage, or other transfer, onto the food or onto surfaces that contact the food ordinarily does not occur during the normal course of operation.
Operating limits – Criteria that are more stringent than critical limits and that are used by an operator to reduce the risk of a deviation.
Packing – Placing food into a container other than packaging the food and also includes re-packing and activities performed incidental to packing or re-packing a food (e.g., activities performed for the safe or effective packing or repacking of that food (such as sorting, culling, grading, and weighing or conveying incidental to packing or re-packing), but does not include activities that transform a raw agricultural commodity into a processed food as defined in section 201(gg) of the Federal Food, Drug, and Cosmetic Act.
Parameter – A characteristic, feature or measurable factor that can help in defining a particular system.
Pathogen – A microorganism of public health significance.
Pest – Any objectionable animals or insects including birds, rodents, flies, and larvae.
Plant – Building or structure or parts thereof, used for or in connection with the manufacturing, processing, packing, or holding of human food.
Potable water – Water that meets the standards for drinking purposes of the State or local authority having jurisdiction, or water that meets the standards prescribed by the U.S. Environmental Protection Agency’s National Primary Drinking Water Regulations (40 CFR 141).
Prerequisite programs – Procedures, including Good Manufacturing Practices (GMPs), that provide the basic environmental and operating conditions necessary to support the Food Safety Plan.
Preventive controls – Those risk-based, reasonably appropriate procedures, practices and processes that a person knowledgeable about the safe manufacturing, processing, packing or holding of food would employ to significantly minimize or prevent the hazards identified under the hazard analysis that are consistent with the current scientific understanding of safe food manufacturing, processing, packaging or holding at the time of the analysis.
Preventive controls qualified individual – A qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety system.
Qualified auditor – A person who is a qualified individual as defined below and has technical expertise obtained through education, training or experience (or a combination thereof) necessary to perform the auditing function as required by 117.180(c)(2). Examples of potentially qualified auditors include:
- A government employee, including a foreign government employee; and
- An audit agent of a certification body that is accredited in accordance with regulations in part 1, subpart M of this chapter.
Qualified end-user – With respect to a food, means the consumer of the food (where the term consumer does not include a business); or a restaurant or retail food establishment (as those terms are defined in § 1.227 of this chapter) that:
- Is located;
- In the same State or the same Indian reservation as the qualified facility that sold the food to such restaurant or establishment; or
- Not more than 275 miles from such facility; and
- Is purchasing the food for sale directly to consumers at such restaurant or retail food establishment.
Qualified facility – (when including the sales by any subsidiary; affiliate; or subsidiaries or affiliates, collectively, of any entity of which the facility is a subsidiary or affiliate) A facility that is a very small business as defined in this part, or a facility to which both of the following apply:
- During the 3-year period preceding the applicable calendar year, the average annual monetary value of the food manufactured, processed, packed or held at such facility that is sold directly to qualified end-users (as defined in this part) during such period exceeded the average annual monetary value of the food sold by such facility to all other purchasers; and
- The average annual monetary value of all food sold during the 3-year period preceding the applicable calendar year was less than $500,000, adjusted for inflation.
Qualified facility exemption – An exemption applicable to a qualified facility under § 117.5(a).
Qualified individual – A person who has the education, training, or experience (or a combination thereof) necessary to manufacture, process, pack, or hold clean and safe food as appropriate to the individual’s assigned duties. A qualified individual may be, but is not required to be, an employee of the establishment.
Quality control operation – A planned and systematic procedure for taking all actions necessary to prevent food from being adulterated.
Raw agricultural commodity – Has the meaning given in section 201(r) of the Federal Food, Drug, and Cosmetic Act.
RTE (Ready-to-eat) food – Any food that is normally eaten in its raw state or any other food, including a processed food, for which it is reasonably foreseeable that the food will be eaten without further processing that would significantly minimize biological hazards.
Reanalysis – A verification procedure to assure that the Food Safety Plan remains valid and the food safety system is operating according to the plan (see Section 117.170).
Receiving facility – A facility that is subject to subpart C [Hazard Analysis and Risk-based Preventive Controls] and subpart G [Supply- Chain Program] of this part and that manufactures/processes a raw material or ingredient that it receives from a supplier.
Rework – Clean, unadulterated food that has been removed from processing for reasons other than insanitary conditions or that has been successfully reconditioned by reprocessing and that is suitable for use as food.
Risk – A function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard(s) in food.
Safe-moisture level – A level of moisture low enough to prevent the growth of undesirable microorganisms in the finished product under the intended conditions of manufacturing, processing, packing, and holding. The safe moisture level for a food is related to 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.
Sanitize – To adequately treat cleaned surfaces by a process that is effective in destroying vegetative cells of pathogens, and in substantially reducing numbers of other undesirable microorganisms, but without adversely affecting the product or its safety for the consumer.
Sanitary conditions – The result of a combination of cleaning and sanitizing, as appropriate for the environment, that prevent the adulteration of food.
Severity – The seriousness of the effects of a hazard.
Significantly minimize – To reduce to an acceptable level, including to eliminate.
Small business – A business employing fewer than 500 full-time equivalent employees.
SOP – Standard Operating Procedure
Subsidiary – Any company which is owned or controlled directly or indirectly by another company.
Supplier – The establishment that manufactures/processes the food, raises the animal or grows the food that is provided to a receiving facility without further manufacturing/processing by another establishment, except for further manufacturing/processing that consists solely of the addition of labeling or similar activity of a de minimis nature.
Supply-chain-applied control – A preventive control for a hazard in a raw material or other ingredients when the hazard in the raw material or other ingredient is controlled before its receipt.
Unexposed packaged food – Packaged food that is not exposed to the environment.
Validation – Obtaining and evaluating scientific and technical evidence that a control measure, combination of control measures, or the food safety plan as a whole, when properly implemented, is capable of effectively controlling the identified hazards.
Verification: – The application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine whether a control measure or combination of control measures is or has been operating as intended and to establish the validity of the food safety plan.
Very small business – A business (including any subsidiaries and affiliates) averaging less than $1,000,000, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed, or held without sale (e.g., held for a fee).
Water activity (aW) – 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.
Written procedures for receiving raw materials and other ingredients – Written procedures to ensure that raw materials and other ingredients are received only from suppliers approved by the receiving facility (or, when necessary and appropriate, on a temporary basis from unapproved suppliers whose raw materials or other ingredients are subjected to adequate verification activities before acceptance for use).