<<Prev Rule

Texas Administrative Code

Next Rule>>
TITLE 25HEALTH SERVICES
PART 1DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 229FOOD AND DRUG
SUBCHAPTER NCURRENT GOOD MANUFACTURING PRACTICE AND GOOD WAREHOUSING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD
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.

  (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.

Cont'd...

Next Page

Link to Texas Secretary of State Home Page | link to Texas Register home page | link to Texas Administrative Code home page | link to Open Meetings home page