1. (1) All persons to whom these rules apply shall obtain a license in accordance with the Tennessee Food, Drug and Cosmetic Act and this chapter.

2. (2) Application for issuance of any license under this chapter shall be made on forms provided by the department, which shall be completed in full and shall include:

   1. (a) Name of the applicant;
   2. (b) Proof of the applicant’s registration in its state of incorporation or business license issued by a local governmental authority;
   3. (c) Contact information for applicant, to include name of person legally responsible for applicant’s operations, telephone number, email address, address of the principal place of business, and address of the facility to be licensed;
   4. (d) Name and address of applicant’s registered agent for service of process, if any.
3. (3) Licensees shall notify the department in writing of any changes to the information or contents of an application within 30 days after the change takes place.

4. (4) Applicants for licensure shall include with their application payment of an annual license fee as appropriate for the following categories of licenses. Fees designated under this rule shall be assessed in accordance with T.C.A. § 43-1-703(f) as it may be amended from time to time.

   1. (a) Food Manufacturer License. A food manufacturer license is required per person and per facility for any kitchen, factory or establishment in the state where food is manufactured, processed, or packed for introduction into commerce. Food manufacturer license fees are determined in accordance with the size of the manufacturer’s facility and the degree of risk the manufacturer poses for outbreak of food borne illness. An establishment greater than 10,000 square feet must obtain a Large Facility license. An establishment equal to or smaller than 10,000 square feet must obtain a Small Facility license. Determination of a manufacturer’s risk for outbreak of food borne illness is made by the department based on the nature of the manufacturer’s operations. Fees applicable for a food manufacturer license are as follows:

      1. 1. Food Manufacturer License, Large Facility – Risk Level 1: Tier 11 license fee;
      2. 2. Food Manufacturer License, Small Facility – Risk Level 1: Tier 10 license fee;
      3. 3. Food Manufacturer License, Large Facility – Risk Level 2: Tier 7 license fee;
      4. 4. Food Manufacturer License, Small Facility – Risk Level 2: Tier 5 license fee;
      5. 5. Food Manufacturer License, Large Facility – Risk Level 3: Tier 3 license fee;
      6. 6. Food Manufacturer License, Small Facility – Risk Level 3: Tier 2 license fee.

   2. (b) Food Warehouse License. A food warehouse license is required for any warehouse or establishment in the state where food is held for introduction into commerce. A food warehouse license is not required for any establishment licensed as a food manufacturer under this chapter or as a food establishment under R. 0080-04-09. Food warehouse license fees are determined in accordance with the degree of risk the warehouse poses for outbreak of food borne illness. This determination is made by the department based on the nature of the warehouse’s operations. Fees applicable for a food warehouse license are as follows:

      1. 1. Food Warehouse License, Risk Level 1: Tier 11 license fee;
      2. 2. Food Warehouse License, Risk Level 2: Tier 7 license fee;
      3. 3. Food Warehouse License, Risk Level 3: Tier 3 license fee.
5. (5) An applicant for licensure under this chapter shall remit its application and annual license fee to the department on or before July 1 of each year. All licenses issued under this chapter shall expire on June 30 following their issuance. If an applicant for renewal fails to remit payment of the license fee on or before July 16 of the licensure year for which renewal is sought, the applicant shall also be required to pay a late charge assessed under T.C.A. § 43- 1-703 prior to renewal of the applicant’s license.
6. (6) The department may deny any application for licensure that is not completed in accordance with this rule.

Authority: T.C.A. §§ 4-3-203, 43-1-703, 53-1-207, and 53-1-208. Administrative History: Original rule filed December 23, 2015; effective March 22, 2016. Amendments filed March 30, 2017; effective June 28, 2017. Amendments filed April 2, 2020; effective July 1, 2020.