(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
Cont'd...
(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
      (iii) $350 for a two-year license that is amended during the current licensure period due to minor changes.
    (C) For each place of business having food storage of 24,001 - 75,000 square feet, the fees are:
      (i) $1,050 for a two-year license;
      (ii) $1,050 for a two-year license that is amended due to a change of ownership; and
      (iii) $525 for a two-year license that is amended during the current licensure period due to minor changes.
    (D) For each place of business having food storage of 75,001 - 250,000 square feet, the fees are:
      (i) $1,400 for a two-year license;
      (ii) $1,400 for a two-year license that is amended due to a change of ownership; and
      (iii) $700 for a two-year license that is amended during the current licensure period due to minor changes.
    (E) For each place of business having food storage of 250,001 or more square feet, the fees are:
      (i) $2,000 for a two-year license;
      (ii) $2,000 for a two-year license that is amended due to a change of ownership; and
      (iii) $1,000 for a two-year license that is amended during the current licensure period due to minor changes.
  (6) A firm that has more than one business location may request a one-time proration of fees when applying for a license for each new location. Upon approval by the department, the expiration date of the license for the new location will be established the same as the firm's previously licensed locations.
  (7) For all applications and renewal applications, the department is authorized to collect subscription and convenience fees, in amounts determined by the Department of Information Resources, to recover costs associated with application and renewal application processing through tex.gov.
  (8) All license/registration fees paid under this section are non-refundable.
  (9) If the license/registration category changes during the license period, the license shall be renewed in the proper category at the time of renewal.
(c) License/registration forms. License/registration forms may be obtained from the department, located at 1100 West 49th Street, Austin, Texas 78756-3182, or from the website at www.dshs.state.tx.us/fdlicense/apps.shtm.
(d) License/registration application. All food manufacturers, food wholesalers, and warehouse operators shall file a license application on a form authorized by the department.
  (1) The application form shall be signed and verified, and shall contain the following information:
    (A) the name of the legal entity to be licensed, including the name under which the business is conducted;
    (B) the physical address of the place of business;
    (C) the mailing address of the place of business;
    (D) if a sole proprietorship, the name of the proprietor; if a partnership, the names of all partners; if a corporation, the name of the corporation, the date and place of incorporation and name and address of its registered agent in the state; or if any other type of association, the names of the principals of such association;
    (E) the names of those individuals in an actual administrative capacity which, in the case of a sole proprietorship shall be the managing proprietor; in a partnership, the managing partner; in a corporation, the officers and directors; in any other association, those in a managerial capacity; and
    (F) a list of categories of gross annual sales or square footage as applicable, which must be marked and adhered to by the licensee in the determination and paying of the license fee.
  (2) Food wholesalers who meet the requirements to register under subsection (b)(7) of this section, must submit a registration form authorized by the department which shall be signed and verified, and contain the following information:
    (A) the name of the legal entity to be registered, including the name under which the business is conducted;
    (B) the name, telephone number, and physical addresses of the licensed warehouses where the food wholesaler's food products are or will be stored;
    (C) the physical address where the food wholesaler's distribution records are located and available for review upon inspection;
    (D) the mailing address and telephone number where the food wholesaler may be contacted; and
Cont'd...
(E) a description of the type of food products being distributed by the food wholesaler.
(e) Two or more establishments. If the food manufacturer, food wholesaler, or warehouse operator operates more than one place of business, each place of business shall be licensed separately by listing the name and address of each place of business on the license application.
(f) Issuance of license/registration. The department may license/register a manufacturer, food wholesaler, or warehouse operator who meets the requirements of this section and §229.183 of this title (relating to Minimum Standards for Licensure/Registration).
  (1) The initial license/registration shall be valid for two years from the date the license/registration was issued.
  (2) The renewal license/registration shall be valid for two years from the date the license/registration was issued.
  (3) A current license/registration shall only be issued when all past due fees and late fees are paid.
(g) Renewal of license/registration.
  (1) For each licensing/registration period, the food manufacturer, food wholesaler, or warehouse operator shall renew its license/registration as applicable following the requirements of this section and §229.183 of this title.
  (2) A person who holds a license/registration issued by the department under the Health and Safety Code shall renew the license/registration by filing an application for renewal on a form authorized by the department accompanied by the appropriate licensing/registration fee. A licensee/registrant must file for renewal before the expiration date of the current license. A person who files a renewal application after the expiration date must pay an additional $100 as a delinquency fee.
  (3) Failure to submit the renewal during the licensing/registration period may subject the food manufacturer, food wholesaler, or warehouse operator to the offense provisions under the Health and Safety Code, Chapter 431, to the provision of §229.184 of this title (relating to the Refusal, Revocation, or Suspension of License/Registration), and to the provisions of §229.222 of this title (relating to Enforcement).
(h) Amendment of license/registration.
  (1) Fees. A license or registration that is amended during the licensing or registration period, including a change of name, ownership (change in legal entity), or a notification of a change in the location of a licensed or registered place of business required under the Health and Safety Code, §431.2251, will require a new application and submission of license or registration fees as outlined in subsection (b) of this section.
  (2) Change in name, ownership, status, or location of business.
    (A) Not later than the 31st day before the date of the change in the name, status, or location of a licensed/registered place of business, the license/registration holder shall provide written notice to the department of the intended change. The notice shall include, as applicable:
      (i) The new name of the legal entity to be licensed or registered, including the name under which the business is conducted;
      (ii) The physical and mailing address of the new location;
      (iii) The name and physical address of the licensed warehouse where the food wholesaler's food products will be stored;
      (iv) The physical address where the food wholesaler's distribution records are located and available for review upon inspection; and
      (v) The mailing address and telephone number where the food wholesaler may be contacted.
    (B) Not later than the 10th day after completion of the change of location, the licensee or registrant shall forward to the department the name and residence address of the individual in charge of the new place of business.
    (C) Notice is considered adequate if the licensee or registrant provides the intent and verification notices to the department by certified mail, return receipt requested, mailed to the department at Regulatory Licensing Unit, Food and Drug Licensing Group, Mail Code 2835, P.O. Box 149347, Austin, Texas 78714-9347.
(i) This section does not apply to:
  (1) a person, firm, or corporation that harvests, packages, or washes raw fruits or vegetables for shipment at the location of harvest;
  (2) a direct seller who is not otherwise engaged in manufacturing;
  (3) a person engaged solely in the distribution of alcoholic beverages in sealed containers by holders of licenses or permits issued under the Alcoholic Beverage Code, Chapters 19, 20, 21, 23, 64, or 65;
  (4) a food service establishment or a commissary which distributes food primarily intended for immediate consumption on the premises of a retail outlet under common ownership unless the business regularly engages in the labeling, combining, and purifying of food which is either sold for resale or packaged for sale in other than individual portions; or
  (5) a restaurant that provides food for immediate human consumption to a political subdivision or to a licensed nonprofit organization if the restaurant would not otherwise be considered a food wholesaler.

Source Note: The provisions of this §229.182 adopted to be effective July 21, 2004, 29 TexReg 6940; amended to be effective February 1, 2006, 31 TexReg 501; amended to be effective March 7, 2007, 32 TexReg 1076; amended to be effective October 11, 2012, 37 TexReg 8027