SECTION 229.211. Definitions

The following words and terms, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise. Those definitions and interpretations of terms of the Texas Food, Drug, and Cosmetic Act, Texas Health and Safety Code, Chapter 431, are also applicable when used in this subchapter.

(1) Acid foods or acidified foods--Foods that have an equilibrium pH of 4.6 or below.

(2) Act--Texas Food, Drug, and Cosmetic Act, Texas Health and Safety Code, Chapter 431.

(3) Adequate--That which is needed to accomplish the intended purpose in keeping with good public health practice.

(4) Adulterated --Has the meaning as defined in the Texas Food, Drug, and Cosmetic Act, Texas Health and Safety Code, Chapter 431.

(5) Affiliate--Any facility that controls, is controlled by, or is under common control with another facility.

(6) Allergen cross-contact--The unintentional incorporation of a food allergen into a food.

(7) Approved source--A supplier of food that complies with applicable state and federal laws and is licensed, if required, and inspected by the regulatory authority having jurisdiction over the processing and distribution of food.

(8) 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.

(9) Batter--A 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.

(10) Blanching (except for tree nuts and peanuts)--A prepackaging heat treatment of foodstuffs for an adequate time and at a sufficient temperature to partially or completely inactivate the naturally occurring enzymes and to effect other physical or biochemical changes in the food.

(11) Calendar day--Every day shown on the calendar.

(12) Cleaning--Physical removal of dirt (soil) from surfaces which includes the use of clean water and detergent.

(13) Conventional handwashing--The washing of hands that relies on hot running water of at least 100 degrees Fahrenheit and a hand cleaning agent to cleanse the hands.

(14) Conventional handwashing sink--A lavatory, trough basin, or vessel for washing, a wash basin, or plumbing fixture especially placed for use in personal hygiene and designed only for washing hands that relies on hot running water of at least 100 degrees Fahrenheit and a hand cleaning agent to cleanse the hands.

(15) 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).

(16) Corrosion Resistant Material--A material that maintains acceptable surface cleanability characteristics under prolonged influence of a food to be contacted, the normal use of cleaning compounds and sanitizing solutions, and other conditions of the use environment.

(17) Critical control point--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.

(18) Defect action level--A level of a non-hazardous, naturally occurring, unavoidable defect at which a food product may be regarded as "adulterated" and subject to enforcement action under Texas Health and Safety Code, §431.081(a)(3).

(19) 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 subchapter include Listeria monocytogenes and Salmonella spp. But do not include the spores of pathogenic sporeforming bacteria.

(20) Facility--

(A) A person who manufactures, wholesales, or otherwise holds food and is subject to the requirements of Texas Health and Safety Code, Chapter 431.

(B) A domestic facility or a foreign facility that is required to register under the Federal Food, Drug, and Cosmetic Act, §415 in accordance with the requirements of 21 Code of Federal Regulations Part 1, Subpart H.

(21) Farm--Means:

(A) Primary production farm. A primary production farm is an operation under one management in one general (but not necessarily contiguous) physical location devoted to the growing of crops, the harvesting of crops, the raising of animals (including seafood), or any combination of these activities. The term "farm" includes operations that, in addition to these activities:

(i) Pack or hold raw agricultural commodities;

(ii) Pack or hold processed food, provided that all processed food used in such activities is either consumed on that farm or another farm under the same management, or is processed food identified in clause (iii)(II)(-a-) of this subparagraph; and

(iii) Manufacture/process food, provided that:

(I) All food used in such activities is consumed on that farm or another farm under the same management; or

(II) Any manufacturing/processing of food that is not consumed on that farm or another farm under the same management consists only of:

(-a-) Drying/dehydrating raw agricultural commodities to create a distinct commodity (such as drying/dehydrating grapes to produce raisins), and packaging and labeling such commodities, without additional manufacturing/processing (an example of additional manufacturing/processing is slicing);

(-b-) Treatment to manipulate the ripening of raw agricultural commodities (such as by treating produce with ethylene gas), and packaging and labeling treated raw agricultural commodities, without additional manufacturing/processing; and

(-c-) Packaging and labeling raw agricultural commodities, when these activities do not involve additional manufacturing/processing (an example of additional manufacturing/processing is irradiation); or

(B) Secondary activities farm. A secondary activities farm is an operation, not located on a primary production farm, devoted to harvesting (such as hulling or shelling), packing, and/or holding of raw agricultural commodities, provided that the primary production farm(s) that grows, harvests, and/or raises the majority of the raw agricultural commodities harvested, packed, and/or held by the secondary activities farm owns, or jointly owns, a majority interest in the secondary activities farm. A secondary activities farm may also conduct those additional activities allowed on a primary production farm as described in subparagraph (A)(ii) and (iii) of this paragraph.

(22) FDA--The Food and Drug Administration.

(23) Food--A raw, cooked, or processed edible substance, ice, beverage, chewing gum or ingredient used or intended for use or for sale in whole or in part for human consumption, including raw materials.

(24) Food allergen--A major food allergen is:

(A) 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.

(B) A food ingredient that contains protein derived from a food specified in subparagraph (A) of this paragraph, except the following.

(i) Any highly refined oil derived from a food specified in subparagraph (A) of this paragraph, and any ingredient derived from such highly refined oil.

(ii) A food ingredient that is exempt under United States Code Title 21 Chapter 9, Subchapter IV, §343(w)(6) and (7).

(25) Food-contact surfaces--Those surfaces that contact human food and those surfaces from which drainage onto the food or onto surfaces that contact the food ordinarily occurs during the normal course of operations. "Food-contact surfaces" includes utensils and food-contact surfaces of equipment.

(26) Full-time equivalent employee--Is 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.

(27) 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. 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.

(28) Hazard--Any biological, chemical (including radiological), or physical agent that has the potential to cause illness or injury.

(29) 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.

(30) 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 pallet loads), but does not include activities that transform a raw agricultural commodity into a processed food. Holding facilities could include warehouses, cold storage facilities, storage silos, grain elevators, and liquid storage tanks.

(31) 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.

(32) Lot--Food produced during a period of time and identified by an establishment's specific code.

(33) 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.

(34) Microorganisms--Yeasts, molds, bacteria, viruses, protozoa, and microscopic parasites and includes species that are pathogens.

(35) Mixed-type facility--An establishment that engages in both activities that are exempt from registration under Federal Food, Drug, and Cosmetic Act, §415 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.

(36) Modified atmosphere packaging--A method of packaging food in which the atmosphere of a package of food is modified so that its composition is different from air, which contains 21% oxygen, 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, removal of air, or an increase in the proportion of other gases such as carbon dioxide or nitrogen.

(37) Monitor--To conduct a planned sequence of observations or measurements to assess whether control measures are operating as intended.

(38) Non-Time/Temperature Control for Safety (TCS) food (NTCS)--(formerly non-Potentially Hazardous Food (non-PHF)) 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 salmonella. 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. A food that because of its pH or a_w value, or interaction of a _w and pH values, is designated as a NTCS food in Tables A and B in §229.211(69). A food that is not designated as a NTCS food in Tables A and B in §229.211(69) and for which there is scientific and technical evidence that a control measure or combination of control measures, when properly implemented, effectively controls the identified hazards in such a manner that growth or toxin formation of pathogenic microorganisms that are reasonably likely to occur in that food, is precluded due to either:

(A) intrinsic factors including added or natural characteristics of the food such as preservatives, antimicrobials, humectants, acidulants, or nutrients;

(B) 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;

(C) a combination of intrinsic and extrinsic factors; or

(D) a food that does not support the growth of or toxin formation of pathogenic microorganisms in accordance with one or more of the conditions above in 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.

(39) Nonprofit food establishment--A charitable entity that prepares or serves food directly to the consumer or otherwise provides food or meals for consumption by humans in the United States. The term includes central food banks, soup kitchens, and nonprofit food delivery services. To be considered a nonprofit food establishment, the establishment must meet the terms of the U.S. Internal Revenue Code (26 United States Code §501(c)(3)).

(40) Packaging--(when used as a verb) Placing food into a container that directly contacts the food and that the consumer receives.

(41) 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 re-packing 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.

(42) Pathogen--A microorganism of public health significance.

(43) Pests--Any objectionable animal or insect including, but not limited to, birds, rodents, flies, and larvae.

(44) Plant--The building or structure, or parts thereof, used for or in connection with the manufacturing, processing, packaging, labeling, or holding of human food.

(45) pH--(Potential of Hydrogen) A measure of the degree of the acidity or the alkalinity of a solution.

(46) Preventive controls--Those risk-based, 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, packing, or holding at the time of the analysis.

(47) Preventive controls individual--An 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.

(48) Processed food--Any food other than a raw agricultural commodity and includes any raw agricultural commodity that has been subject to processing, such as but not limited to, canning, cooking, freezing, dehydration, or milling.

(49) Processing--Including, but not limited, to the preparing, blending, filtering, preserving, treating, changing into different market forms, manufacturing, packing, repacking, or labeling of food ingredients and or products.

(50) Qualified auditor--A person who is an individual as defined in this part and has technical expertise obtained through education, training, or experience (or a combination thereof) necessary to perform the auditing function as required by 21 Code of Federal Regulations §117.180(c)(2). Examples of potential qualified auditors include:

(A) a government employee, including a foreign government employee; and

(B) an audit agent of a certification body that is accredited in accordance with regulations in 21 CFR, Part 1, Subpart M.

(51) Qualified end-user--With respect to a food, 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 this) section that:

(A) is located:

(i) in the same State or the same Indian reservation as the qualified facility that sold the food to such restaurant or establishment; or

(ii) not more than 275 miles from such facility; and

(B) is purchasing the food for sale directly to consumers at such restaurant or retail food establishment.

(52) 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:

(A) 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 section) during such period exceeded the average annual monetary value of the food sold by such facility to all other purchasers; and

(B) 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.

(53) Qualified facility exemption--An exemption applicable to a qualified facility under 21 Code of Federal Regulations §117.5(a).

(54) 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.

(55) Quality control operation--A planned and systematic procedure for taking all actions necessary to prevent food from being adulterated.

(56) Raw agricultural commodity--Any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form prior to marketing.

(57) Ready-to-eat food (RTE 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.

(58) Receiving facility--A facility that is subject to 21 Code of Federal Regulations Part 117 Subparts C and G and that manufactures/processes a raw material or other ingredient that it receives from a supplier.

(59) Restaurant--A facility that prepares and sells food directly to consumers for immediate consumption. "Restaurant" does not include facilities that provide food to interstate conveyances, central kitchens, and other similar facilities that do not prepare and serve food directly to consumers. Entities in which food is provided to humans, such as cafeterias, lunchrooms, cafes, bistros, fast food establishments, food stands, saloons, taverns, bars, lounges, catering facilities, hospital kitchens, day care kitchens, and nursing home kitchens are restaurants.

(60) Retail food establishment--An establishment that sells food products directly to consumers as its primary function. The term "retail food establishment" includes facilities that manufacture, process, pack, or hold food if the establishment's primary function is to sell from that establishment food, including food that it manufactures, processes, packs, or holds, directly to consumers. A retail food establishment's primary function is to sell food directly to consumers if the annual monetary value of sales of food products directly to consumers exceeds the annual monetary value of sales of food products to all other buyers. The term "consumers" does not include businesses. A "retail food establishment" includes grocery stores, convenience stores, and vending machine locations. A "retail food establishment" also includes certain farm-operated businesses selling food directly to consumers as their primary function.

(A) Sale of food directly to consumers from an establishment located on a farm includes sales by that establishment directly to consumers:

(i) At a roadside stand (a stand situated on the side of or near a road or thoroughfare at which a farmer sells food from his or her farm directly to consumers) or farmers' market (a location where one or more local farmers assemble to sell food from their farms directly to consumers);

(ii) Through a community supported agriculture program. Community supported agriculture (CSA) program means a program under which a farmer or group of farmers grows food for a group of shareholders (or subscribers) who pledge to buy a portion of the farmer's crop(s) for that season. This includes CSA programs in which a group of farmers consolidate their crops at a central location for distribution to shareholders or subscribers; and

(iii) At other such direct-to-consumer sales platforms, including door-to-door sales; mail, catalog and Internet order, including online farmers markets and online grocery delivery; religious or other organization bazaars; and State and local fairs.

(B) Sale of food directly to consumers by a farm-operated business includes the sale of food by that farm-operated business directly to consumers:

(i) At a roadside stand (a stand situated on the side of or near a road or thoroughfare at which a farmer sells food from his or her farm directly to consumers) or farmers' market (a location where one or more local farmers assemble to sell food from their farms directly to consumers);

(ii) Through a community supported agriculture program. Community supported agriculture (CSA) program means a program under which a farmer or group of farmers grows food for a group of shareholders (or subscribers) who pledge to buy a portion of the farmer's crop(s) for that season. This includes CSA programs in which a group of farmers consolidate their crops at a central location for distribution to shareholders or subscribers; and

(iii) At other such direct-to-consumer sales platforms, including door-to-door sales; mail, catalog and Internet order, including online farmers markets and online grocery delivery; religious or other organization bazaars; and State and local fairs.

(C) For the purposes of this definition, "farm-operated business" means a business that is managed by one or more farms and conducts manufacturing/processing not on the farm(s).

(61) 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.

(62) 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 (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 (a_w ) will not support the growth of undesirable microorganisms.

(63) Sanitize--Following cleaning, a process to treat a clean surface 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.

(64) Significantly minimize--To reduce to an acceptable level, including to eliminate.

(65) Small business--For purposes of this subchapter, a business employing fewer than 500 full-time equivalent employees.

(66) Subsidiary--Any company which is owned or controlled directly or indirectly by another company.

(67) 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.

(68) Supply-chain-applied control--A preventive control for a hazard in a raw material or other ingredient when the hazard in the raw material or other ingredient is controlled before its receipt.

(69) Time/Temperature Control for Safety (TCS) food--(formerly Potentially Hazardous Food (PHF)), A food that requires time/temperature control for safety to limit pathogenic microorganism growth or toxin formation. An animal based food that is raw or heat-treated. A plant based food that is heat-treated or consists of raw seed sprouts, cut melons, cut leafy greens, cut tomatoes or mixture 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. Except as specified in Tables A and B of this paragraph, a food that because of the interaction of a_w and pH values is designated as requiring scientific and technical evidence that a control measure or combination of control measures, when properly implemented, effectively controls the identified hazards:

(A) Table A.

Attached Graphic

(B) Table B.

Attached Graphic

(70) Undesirable microorganisms--Includes those microorganisms that are pathogens, that subject food to decomposition, that indicate that food is contaminated with filth, or that otherwise may cause food to be adulterated.

(71) Unexposed packaged food--Packaged food that is not exposed to the environment.

(72) 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.

(73) 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.

(74) Very small business--For purposes of this subchapter, a business (including any subsidiaries and affiliates) averaging less than readtac$ext.TacPage?sl=T&app=9&p_dir=F&p_rloc=185006&p_tloc=29639&p_ploc=19666&pg=4&p_tac=&ti=25&pt=1&ch=229&rl=211,000,000, 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).

(75) Water activity (a_w )--A measure of the free moisture in a food. The quotient of the water vapor pressure of the substance divided by the vapor pressure of pure water at the same temperature.

(76) 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).

(77) You--For purposes of this subchapter, the owner, operator, or agent in charge of a facility.

Source Note: The provisions of this §229.211 adopted to be effective August 2, 2017, 42 TexReg 3789