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TITLE 25HEALTH SERVICES
PART 1DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 229FOOD AND DRUG
SUBCHAPTER LLICENSURE OF FOOD MANUFACTURERS, FOOD WHOLESALERS, AND WAREHOUSE OPERATORS
RULE §229.182Licensing/Registration Fee and Procedures

(a) License/registration required.

  (1) A person who manufactures food must obtain a food manufacturer's license for each place of business as described in subsection (b)(1) or (2) of this section; also, a food manufacturer who distributes its own food, and/or food from another manufacturer must only obtain a food manufacturer's license. When calculating the amount of the licensing fee, the manufacturer must include the total for all food manufactured and wholesaled from the place of business.

  (2) A person who distributes food, but who does not manufacture food, must obtain a food wholesaler's license for each place of business as described in subsection (b)(3) or (4) of this section.

  (3) A person who distributes food, but who does not manufacture food, and who chooses to store that food with a warehouse operator licensed under subsection (b)(8) or (9) of this section, must register as a food wholesaler under subsection (b)(7) of this section.

  (4) A person who distributes food and drugs, food and medical devices, or food and drugs and medical devices, must obtain a wholesaler with combination products license, as described in subsection (b)(5) or (6) of this section, for each place of business; this license is required even if the products are stored in a separate warehouse or with a warehouse operator licensed under subsection (b)(8) or (9) of this section.

  (5) A warehouse operator storing food for a registered food wholesaler must obtain a warehouse operator license as described in subsection (b)(8) or (9) of this section for each such warehouse. A warehouse operator who distributes only food is required to obtain only a warehouse operator license. A warehouse operator who distributes combination products (food and drugs, food and medical devices, or food, drugs, and medical devices) and is also required to obtain a wholesaler's license under subsection (b)(5) or (6) of this section will be issued only one license. The license fee to be paid will be the higher of the two applicable fees.

  (6) A warehouse operated by a food manufacturer which is totally separate from any manufacturing location, including locations from which foods are held for limited periods of time for distribution, must obtain a warehouse operator license as described in subsection (b)(8) or (9) of this section for each such warehouse.

  (7) A retail food store that also manufactures food and is required to be permitted by the Department of State Health Services (department) pursuant to Health and Safety Code, Chapter 437, and the Texas Food Establishment Regulations, §229.370 and §229.371 of this title (relating to Permitting Retail Food Establishments), will be issued only one license or permit. The license or permit fee to be paid will be the higher of the two applicable fees.

  (8) A wholesaler who distributes combination products and who is also required to be licensed as a warehouse operator under this section will be issued only one license. The license fee to be paid will be the higher of the two applicable fees.

  (9) A food manufacturer required to be licensed exclusively pursuant to Health and Safety Code, Chapter 432, relating to Food, Drug, Device and Cosmetic Salvage, Chapter 433, relating to Meat and Poultry Inspection, Chapter 435, relating to Dairy Products, Chapter 436, relating to Aquatic Life, or Chapter 440, relating to Frozen Desserts, is not required to license pursuant to this chapter.

(b) Licensing and registration fees.

  (1) Food manufacturer. No person may operate or conduct business as a food manufacturer in this state without first obtaining a license from the department. Licenses issued under this subsection expire two years from the start date of the regulated activity. All applicants for a new or renewal food manufacturer's license shall pay a license fee.

    (A) For each place of business having gross annual manufactured food sales of $0.00 - $9,999.99, the fees are:

      (i) $100 for a two-year license;

      (ii) $100 for a two-year license that is amended due to a change of ownership; and

      (iii) $50 for a two-year license that is amended during the current licensure period due to minor changes.

    (B) For each place of business having gross annual manufactured food sales of $10,000 - $24,999.99, the fees are:

      (i) $150 for a two-year license;

      (ii) $150 for a two-year license that is amended due to a change of ownership; and

      (iii) $75 for a two-year license that is amended during the current licensure period due to minor changes.

    (C) For each place of business having gross annual manufactured food sales of $25,000 - $99,999.99, the fees are:

      (i) $250 for a two-year license;

      (ii) $250 for a two-year license that is amended due to a change of ownership; and

      (iii) $125 for a two-year license that is amended during the current licensure period due to minor changes.

    (D) For each place of business having gross annual manufactured food sales of $100,000 - $199,999.99, the fees are:

      (i) $560 for a two-year license;

      (ii) $560 for a two-year license that is amended due to a change of ownership; and

      (iii) $280 for a two-year license that is amended during the current licensure period due to minor changes.

    (E) For each place of business having gross annual manufactured food sales of $200,000 - $999,999.99, the fees are:

      (i) $900 for a two-year license;

      (ii) $900 for a two-year license that is amended due to a change of ownership; and

      (iii) $450 for a two-year license that is amended during the current licensure period due to minor changes.

    (F) For each place of business having gross annual manufactured food sales of $1 million - $9,999,999.99, the fees are:

      (i) $1,120 for a two-year license;

      (ii) $1,120 for a two-year license that is amended due to a change of ownership; and

      (iii) $560 for a two-year license that is amended during the current licensure period due to minor changes.

    (G) For each place of business having gross annual manufactured food sales greater than or equal to $10 million, the fees are:

      (i) $1,680 for a two-year license;

      (ii) $1,680 for a two-year license that is amended due to a change of ownership; and

      (iii) $840 for a two-year license that is amended during the current licensure period due to minor changes.

  (2) Food wholesaler. No person may operate or conduct business as a food wholesaler in this state without first obtaining a food wholesaler's license from the department. Licenses issued under this subsection expire two years from the start date of the regulated activity. Except as provided for in paragraph (4) of this subsection, all food wholesalers shall pay a license fee.

    (A) For each place of business having gross annual food sales of $0.00 - $199,999.99, the fees are:

      (i) $250 for a two-year license;

      (ii) $250 for a two-year license that is amended due to a change of ownership; and

      (iii) $125 for a two-year license that is amended during the current licensure period due to minor changes.

    (B) For each place of business having gross annual food sales of $200,000 - $499,999.99, the fees are:

      (i) $450 for a two-year license;

      (ii) $450 for a two-year license that is amended due to a change of ownership; and

      (iii) $225 for a two-year license that is amended during the current licensure period due to minor changes.

    (C) For each place of business having gross annual food sales of $500,000 - $999,999.99, the fees are:

      (i) $680 for a two-year license;

      (ii) $680 for a two-year license that is amended due to a change of ownership; and

      (iii) $340 for a two-year license that is amended during the current licensure period due to minor changes.

    (D) For each place of business having gross annual food sales of $1 million - $9,999,999.99, the fees are:

      (i) $900 for a two-year license;

      (ii) $900 for a two-year license that is amended due to a change of ownership; and

      (iii) $450 for a two-year license that is amended during the current licensure period due to minor changes.

    (E) For each place of business having gross annual food sales of greater than or equal to $10 million, the fees are:

      (i) $1,350 for a two-year license;

      (ii) $1,350 for a two-year license that is amended due to a change of ownership; and

      (iii) $675 for a two-year license that is amended during the current licensure period due to minor changes.

  (3) Wholesaler with combination products. A person who is required to be licensed as a food wholesaler under this section and who is also required to be licensed as a wholesale distributor of drugs under §229.249(a) of this title (relating to Licensure Fees) or as a device distributor under §229.439(a)(1) of this title (relating to Licensure Fees) shall pay a combined licensure fee for each place of business. The licensure fee shall be based on the combined gross annual sales of these regulated products (foods, drugs, and/or devices).

    (A) For each place of business having combined gross annual sales of $0.00 - $199,999.99, the fees are:

      (i) $520 for a two-year license;

      (ii) $520 for a two-year license that is amended due to a change of ownership; and

      (iii) $260 for a license that is amended during the current licensure period due to minor changes.

    (B) For each place of business having combined gross annual sales of $200,000 - $499,999.99, the fees are:

      (i) $780 for a two-year license;

      (ii) $780 for a two-year license that is amended due to a change of ownership; and

      (iii) $390 for a license that is amended during the current licensure period due to minor changes.

    (C) For each place of business having combined gross annual sales of $500,000 - $999,999.99, the fees are:

      (i) $1,040 for a two-year license;

      (ii) $1,040 for a two-year license that is amended due to a change of ownership; and

      (iii) $520 for a license that is amended during the current licensure period due to minor changes.

    (D) For each place of business having combined gross annual sales of $1 million - $9,999,999.99, the fees are:

      (i) $1,300 for a two-year license;

      (ii) $1,300 for a two-year license that is amended due to a change of ownership; and

      (iii) $650 for a license that is amended during the current licensure period due to minor changes.

    (E) For each place of business having combined gross annual sales greater than or equal to $10 million, the fees are:

      (i) $1,950 for a two-year license;

      (ii) $1,950 for a two-year license that is amended due to a change of ownership; and

      (iii) $975 for a license that is amended during the current licensure period due to minor changes.

  (4) Food wholesaler registration. Except as provided in paragraph (3) of this subsection, a food wholesaler is not required to obtain a license under this section for a place of business if all of the food distributed from that place of business will be stored in a warehouse licensed under this section. A food wholesaler that is not required to obtain a license for a place of business under this section shall register each place of business with the department pursuant to subsection (d)(2) of this section, but only one registration fee must be paid by each such food wholesaler. A food wholesaler who meets this subsection's requirements shall pay a registration fee of $100. A registration issued under this subsection expires two years from the start date of the regulated activity.

  (5) Warehouse operator. No person may operate or conduct business as a warehouse operator in this state without first obtaining a license from the department. Licenses issued under this subsection expire two years from the start date of the regulated activity. License fees are based on the maximum amount of square feet dedicated to food storage during the licensing period. A warehouse operator shall pay a license fee.

    (A) For each place of business having food storage of 0 - 6,000 square feet, the fees are:

      (i) $350 for a two-year license;

      (ii) $350 for a two-year license that is amended due to a change of ownership; and

      (iii) $175 for a two-year license that is amended during the current licensure period due to minor changes.

    (B) For each place of business having food storage of 6,001 - 24,000 square feet, the fees are:

      (i) $700 for a two-year license;

      (ii) $700 for a two-year license that is amended due to a change of ownership; and

Cont'd...

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