TN Code § 53-1-208 (2021)
2021 Tennessee Code|Title 53 - Food, Drugs and Cosmetics|Chapter 1 - Tennessee Food, Drug and Cosmetic Act|Part 2 - Enforcement|§ 53-1-208. Inspections — Examination of Specimens

  The commissioner or the commissioner's duly authorized agent shall have free access at all reasonable hours to any factory, warehouse or establishment in which foods, drugs, devices or cosmetics are manufactured, processed, packed or held for introduction into commerce, or to enter any vehicle being used to transport or hold the foods, drugs, devices or cosmetics in commerce, for the purpose of:  Inspecting the factory, warehouse, establishment or vehicle to determine if this chapter is being violated; and   Securing samples or specimens of any food, drug, device or cosmetic after paying or offering to pay for the sample. It is the duty of the commissioner to make or cause to be made examination of samples secured under this section to determine whether or not this chapter is being violated;     Except as provided in subsection (d), no person shall manufacture, process, pack, or hold food for introduction into commerce unless the person holds a valid license issued by the commissioner. Applicants for licensure shall submit an application for the license on forms provided by the commissioner. The commissioner may issue a license to an applicant only upon receipt of the proper license fee and an inspection of the applicant's facility that indicates the applicant is in compliance with the requirements of this part and the rules promulgated thereunder. Licenses issued under this section shall expire on July 1 of each year or as the commissioner may otherwise provide by rule. The commissioner shall set annual fees for licenses issued under this section by rule pursuant to § 43-1-703. Notwithstanding § 43-1-704(b), the commissioner shall set fees for licenses issued under this section on or before April 1, 2018.   The commissioner shall set by rule pursuant to § 43-1-703 a fee for a certificate of free sale.   No license shall be required under this section for any person who manufactures, processes, packs, or holds food for introduction into commerce, if:  The food is not potentially hazardous, as defined by departmental regulation;   The person is not subject to any license or permit requirements under § 53-3-105, § 53-3-106, § 53-7-216, § 53-7-220, or § 53-8-206;   The person introduces food into commerce only through direct retail sales to end consumers in the state;   The person employs no regular, full-time employees for the manufacturing, processing, packing, or holding of food; and   Prior to introducing the food into commerce, the person labels the food in accordance with this part and regulations promulgated by the commissioner.     Exemption from licensure requirements under this section shall not be construed to exempt any person from any other regulations applicable to the manufacturing, processing, packing, or holding of food for introduction into commerce, including, but not limited to, requirements regarding recordkeeping, sanitary operation, and availability for inspection by agencies charged with enforcing food safety laws.   A license shall not be required for the operation of a farm to consumer distribution point; provided, that the operator of the farm to consumer distribution point:  Has registered the farm to consumer distribution point with the department of revenue for purposes of paying the sales tax under any agreement entered into between a farmer and a consumer pursuant to which the farmer or the farmer's agent delivers food, produced by the farmer and previously sold to the consumer by the farmer, directly to the consumer or the consumer's agent at the farm to consumer distribution point; and   Agrees to only allow deliveries of meats produced by farmers who comply with the Tennessee Meat and Poultry Inspection Act, compiled in chapter 7, part 2 of this title to be made at the farm to consumer distribution point.