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RULE §229.211Definitions

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.


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