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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 §229.213Exemptions

bone meal) in powdered, granular, or other solid form);

    (W) packaging baked goods (e.g., bread and cookies), candy, cocoa beans (roasted), cocoa products, coffee beans (roasted), game meat jerky, gums/latexes/resins that are processed foods, honey (pasteurized), jams/jellies/preserves, milled grain products (e.g., flour, bran, corn meal), molasses and treacle, oils, other fruit and vegetable products (e.g., pitted, dried fruits; sliced, dried apples; snack chips), other grain products (e.g., popcorn), other herb and spice products (e.g., chopped or ground dried herbs), peanut and tree nut products, processed seeds for direct consumption, soft drinks and carbonated water, sugar, syrups, trail mix and granola, vinegar, and any other processed food that does not require time/temperature control for safety (e.g., vitamins, minerals, and dietary ingredients (e.g., bone meal) in powdered, granular, or other solid form);

    (X) pasteurizing honey;

    (Y) roasting and toasting baked goods (e.g., toasting bread for croutons);

    (Z) salting other grain products (e.g., soy nuts), peanut and tree nut products, and processed seeds for direct consumption; and

    (AA) sifting milled grain products (e.g., flour, bran, corn meal), other fruit and vegetable products (e.g., chickpea flour), and peanut and tree nut products (e.g., peanut flour, almond flour).

(i) Alcoholic beverages.

  (1) 21 Code of Federal Regulations Part 117 Subparts C and G do not apply with respect to alcoholic beverages at a facility that meets the following two conditions:

    (A) Under the Federal Alcohol Administration Act (27 United States Code 201 et seq.) or Chapter 51 of Subtitle E of the Internal Revenue Code of 1986 (26 United States Code 5001 et seq.) the facility is required to obtain a permit from, register with, or obtain approval of a notice or application from the Secretary of the Treasury as a condition of doing business in the United States, or is a foreign facility of a type that would require such a permit, registration, or approval if it were a domestic facility; and

    (B) Under the Federal Food, Drug, and Cosmetic Act, §415, the facility is required to register as a facility because it is engaged in manufacturing, processing, packing, or holding one or more alcoholic beverages.

  (2) 21 Code of Federal Regulations Part 117 Subparts C and G do not apply with respect to food that is not an alcoholic beverage at a facility described in paragraph (1) of this subsection, provided such food:

    (A) is in prepackaged form that prevents any direct human contact with such food; and

    (B) constitutes not more than 5 percent of the overall sales of the facility, as determined by the Secretary of the Treasury.

(j) 21 Code of Federal Regulations Part 117 Subparts C and G do not apply to facilities that are solely engaged in the storage of raw agricultural commodities (other than fruits and vegetables) intended for further distribution or processing.

(k) Exemptions to Subchapter N.

  (1) Except as provided by paragraph (2) of this subsection, Subchapter N of this chapter does not apply to any of the following:

    (A) "farms;"

    (B) fishing vessels that are not subject to the registration requirements of 21 Code of Federal Regulations Part 1, Subpart H in accordance with 21 Code of Federal Regulations §1.226(f);

    (C) establishments solely engaged in the holding and/or transportation of one or more raw agricultural commodities;

    (D) activities of "farm mixed-type facilities" as defined under mixed-type facility in §229.211 of this title that fall within the definition of "farm;" or

    (E) establishments solely engaged in hulling, shelling, drying, packing, and/or holding nuts except in the case where the nut is cracked and/or shelled and is intended to be consumed raw (without additional manufacturing/processing, such as roasting nuts).

  (2) If a "farm" or "farm mixed-type facility" dries/dehydrates raw agricultural commodities that are produce as defined in 21 Code of Federal Regulations Part 112, to create a distinct commodity, Subchapter N of this chapter applies to the packaging, packing, and holding of the dried commodities. Compliance with this requirement may be achieved by complying with Subchapter N of this chapter or with the applicable requirements for packing and holding in 21 Code of Federal Regulations Part 112.


Source Note: The provisions of this §229.213 adopted to be effective August 2, 2017, 42 TexReg 3789

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