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HEMP AND CBD LAWS

HEMP - GENERAL PROVISIONS

Tenn. Code Ann. § 43-27-101 "Chapter Definitions:"

As used in this chapter:

• (1) "Commissioner" means the commissioner of agriculture;
• (2) "Department" means the department of agriculture;
• (3) "Hemp" means the plant cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol (THC) concentration of not more than three-tenths of one percent (0.3%) on a dry weight basis;
• (4) "Hemp concentrate" means a concentrate with a delta-9 tetrahydrocannabinol (THC) concentration of not more than five percent (5%) that is derived from hemp solely for purposes of reconstitution into consumer products with a delta-9 tetrahydrocannabinol (THC) concentration of not more than three-tenths of one percent (0.3%); and
• (5) "THC" means delta-9 tetrahydrocannabinol.

Tenn. Code Ann. § 43-27-102 “Hemp license - Requirements - Records”

• (a) Any person who produces hemp in this state shall obtain an annual license from the department.
• (b) In order to obtain and maintain a hemp license, a person must:
• (1) Submit to the department a description of all land on which the person produces hemp in this state, to include global positioning system coordinates and other information sufficient to identify the property;
• (2) Submit to the department any other information prescribed by rules as necessary for the efficient enforcement of this chapter;
• (3) Consent to reasonable inspection and sampling by the department of the person's hemp crop and inventory; and
• (4) Not be convicted of a state or federal felony drug offense within the previous ten (10) years.
• (c) The department shall maintain all records that the department creates, or that are submitted to the department, for regulation of hemp in this state for a period of at least five (5) years.

Tenn. Code Ann. § 43-27-103 “Prohibited acts - Exceptions”

• (a) The following acts within this state are prohibited:
• (1) Possession of rooted hemp by any person, other than a common carrier, without a valid license issued by the department;
• (2) Possession of cannabis with THC concentrations greater than three-tenths of one percent (0.3%) on a dry weight basis;
• (3) Failure to pay upon reasonable notice any license, sampling, or inspection fee assessed by the department;
• (4) Violation of this chapter or any rule promulgated under this chapter; or
• (5) Willful hindrance of the commissioner or the commissioner's authorized agent in performance of their official duties.
• (b) It is an exception to the application of subdivision (a)(2) that the only cannabis with a THC concentration greater than three-tenths of one percent (0.3%) on a dry weight basis in the person's possession was hemp concentrate and the person was transporting the hemp concentrate within this state from the location where the hemp concentrate was produced to a location where the hemp concentrate was to be reconstituted into consumer products with a THC concentration of not more than three-tenths of one percent (0.3%); provided, however, that the person transporting the hemp concentrate under this subsection (b) must maintain proof of a grower's license from the department in the transport vehicle.

Tenn. Code Ann. § 43-27-104 “Authority of commissioner”

• (a) The commissioner is authorized to:
• (1) Administer this chapter;
• (2) Take all action necessary to obtain primary regulatory authority over the production of hemp in this state, as authorized by Section 297 of the Agriculture Improvement Act of 2018 (Public Law 115-334);
• (3) Promulgate rules in accordance with the Uniform Administrative Procedures Act, compiled in title 4, chapter 5, as necessary for regulation of hemp in accordance with the federal Agriculture Improvement Act of 2018 and as determined by the commissioner to be necessary for the efficient enforcement of this chapter;
• (4) Determine requirements for and issue licenses for the production of hemp in this state;
• (5) Deny or revoke licenses and issue civil penalties up to one thousand dollars ($1,000) for each violation of this chapter or its rules;
• (6) Establish reasonable fees for hemp licenses necessary to implement and administer a hemp program in this state on an ongoing basis. All revenue collected from fees established under this subdivision (a)(6) must be used exclusively for administration of a hemp regulatory program by the department;
• (7) Require the maintenance or filing of records;
• (8) Enter during normal business hours any premises or conveyance of a person licensed under this chapter for purposes of inspection, sampling, and observation and copying of records required under this chapter; and
• (9) Provide, on at least a quarterly basis, a list of persons licensed pursuant to this chapter to the department of safety, for the department of safety's publication on its website. A licensee's inclusion on the list may be used as proof for purposes of satisfying the exception described in § 39-17-427(2).
• (b) All rules promulgated by the department prior to July 1, 2019, for regulation of industrial hemp are null and void immediately upon rules promulgated to effectuate chapter 87 of the Public Acts of 2019 taking effect. Within one hundred twenty (120) days of chapter 87 of the Public Acts of 2019 becoming law, the department shall promulgate rules necessary to effectuate the purposes of this chapter. The commissioner is authorized to file emergency rules under § 4-5-208 as necessary for compliance with this subsection (b).

Tenn. Code Ann. § 43-27-105 “Enforcement of chapter - Sample and analysis of hemp produced in state”

• a) The department shall enforce this chapter in a manner that may reasonably be expected to prevent production or distribution of cannabis with THC concentrations exceeding three-tenths of one percent (0.3%) on a dry weight basis, including random inspections and sampling of hemp licensees to ensure compliance with this chapter and rules promulgated under this chapter.
• (b) The department shall sample and analyze hemp produced in this state and hemp products distributed in this state for THC concentrations, tested according to protocols prescribed by rule under this chapter. Departmental testing methods shall employ liquid chromatography tandem mass spectrometry, in a manner similarly reliable to post-decarboxylation, to determine a cannabinoid profile of samples tested, including their THC concentrations.

Tenn. Code. Ann. § 43-27-106 “Stop movement or destruction order for plant or product exceeding authorized concentrations - Penalties - Evidence”

• (a) When the commissioner or the commissioner's authorized agent finds any cannabis or cannabis product to contain THC concentrations greater than three-tenths of one percent (0.3%) on a dry weight basis, the commissioner may issue either a written stop movement order or written destruction order for the plant or product, as appropriate to best serve the public interest and purpose of this chapter.
• (b) Any person who negligently violates this chapter or rules promulgated under this chapter is subject to administrative action by the department including denial or revocation of any license issued under this chapter; issuance of stop movement orders, destruction orders, and civil penalties; and actions for injunction. Negligent violations of this chapter or rules promulgated under this chapter shall not be the basis for criminal prosecution of any person.
• (c) Any person who violates this chapter or rules promulgated under this chapter with a culpable mental state greater than negligence shall be subject to prosecution under any applicable state or federal law. If the department determines that a person has violated this chapter or rules promulgated under this chapter with a culpable mental state greater than negligence, the department shall report the matter to the Tennessee bureau of investigation and the United States attorney general.
• (d) In all proceedings brought to enforce this chapter, proof of testing consistent with rules promulgated under this chapter showing THC concentrations greater than three-tenths of one percent (0.3%), but not greater than one percent (1.0%), on a dry weight basis is prima facie evidence of a negligent violation of this chapter.
• (e) In all proceedings brought to enforce this chapter, the following are prima facie evidence of violation with a culpable mental state greater than negligence:
• (1) Proof of testing consistent with rules promulgated under this chapter showing THC concentrations greater than one percent (1.0%) on a dry weight basis;
• (2) Three (3) violations within a five-year period for possession of rooted hemp without a valid license issued by the department; or
• (3) Violation of any stop movement or destruction order issued under this chapter.
• (f) Any person whose license is revoked for violation of this chapter or rules promulgated under this chapter is ineligible for reissuance of the license for a period of at least five (5) years.
• (g) It is an exception to the application of this section that the only cannabis with a THC concentration greater than three-tenths of one percent (0.3%) on a dry weight basis in the person's possession was hemp concentrate and the person was transporting the hemp concentrate within this state from the location where the hemp concentrate was produced to a location where the hemp concentrate was to be reconstituted into consumer products with a THC concentration of not more than three-tenths of one percent (0.3%); provided, however, that the person transporting the hemp concentrate under this subsection (g) must maintain proof of a grower's license from the department in the transport vehicle.
  

Tenn. Code Ann. § 43-27-107 “Jurisdiction for violations”

When the commissioner has reason to believe that a person is causing or has caused a violation of this chapter or the rules promulgated under this chapter, the commissioner may initiate proceedings in either the chancery court of Davidson County or the chancery court of the county where the violation occurred, for injunctive relief to prevent the continuance of the violation or to correct the conditions resulting in the violation.

Tenn. Code Ann. § 43-27-108 “Exemption from other applicable statutes and rules not provided by this chapter”

This chapter does not exempt any person from enforcement of statutes and rules applicable to particular uses of hemp, including, but not limited to, food safety statutes and rules for distribution of food products; feed statutes and rules for distribution of commercial feed; and seed statutes and rules for distribution of seed.

HEMP - DERIVED CANNABINOIDS

Tenn. Code Ann. § 43-27-201 "[Effective 7/1/2024] Purpose"

The purpose of this part is to regulate the sale and distribution of products containing a hemp-derived cannabinoid.

Tenn. Code Ann. § 43-27-202 “Part definitions”

As used in this part, unless the context otherwise requires:

• (1) "Batch" means a single stock keeping unit with common cannabinoid input or a hemp flower of the same varietal and harvested on the same date and manufactured during a defined cycle in such a way that it could be expected to be of a uniform character and should be designated as such;
• (2) "Hemp-derived cannabinoid":
• (A) Means:
• (i) A cannabinoid other than delta-9 tetrahydrocannabinol, or an isomer derived from such cannabinoid, that is derived from hemp in a concentration of more than one-tenth of one percent (0.1%); or
• (ii) A hemp-derived product containing delta-9 tetrahydrocannabinol in a concentration of three-tenths of one percent (0.3%) or less on a dry weight basis;
• (B) Includes, but is not limited to:
• (i) Delta-8 tetrahydrocannabinol;
• (ii) Delta-10 tetrahydrocannabinol;
• (iii) Hexahydrocannabinol;
• (iv) Tetrahydrocannabiphorol (THCp);
• (v) Tetrahydrocannabivarin (THCv); and
• (vi) Tetrahydrocannabinolic acid (THCa); and
• (C) Does not include:
• (i) Cannabichromene (CBC/CBCa/CBCv);
• (ii) Cannabicitran (CBT/CBTa);
• (iii) Cannabicyclol (CBL/CBLa);
• (iv) Cannabidiol (CBD/CBDa/CBDv/CBDp);
• (v) Cannabielsoin (CBE/CBEa);
• (vi) Cannabigerol (CBG/CBGa/CBGv/CBGm);
• (vii) Cannabinol (CBN/CBNa);
• (viii) Cannabivarin (CBV/CBVa);
• (ix) Hemp-derived feed products allowed under title 44, chapter 6;
• (x) Hemp-derived fiber, grain, or topical products; or
• (xi) A substance that is categorized as a Schedule I controlled substance on or after July 1, 2023, including a substance that may be identified in subdivision (2)(B);
• (3) "Manufacture" means to compound, blend, extract, infuse, cook, or otherwise make or prepare products containing a hemp-derived cannabinoid, including the processes of extraction, infusion, packaging, repackaging, labeling, and relabeling of products containing a hemp-derived cannabinoid;
• (4) "Proof of age" means a valid driver license or other government-issued identification card that contains a photograph of the person and confirms the person's age as twenty-one (21) years of age or older;
• (5) "Retailer" means a person or entity that sells products containing a hemp-derived cannabinoid for consumption and not for resale;
• (6) "Serving" means a quantity of a hemp-derived cannabinoid product reasonably suitable for a single person's daily use; and
• (7) "Supplier" means a person or entity that manufactures hemp-derived cannabinoids or sells products containing hemp-derived cannabinoids to retailers.

Tenn. Code Ann. § 43-27-203 “[Effective Until 7/1/2024] Offenses and penalties for manufacturing, producing, or selling hemp - derived cannabinoid products”

• (a) [Effective July 1, 2024. See the second version of this section.]
• (b)
• (1) It is an offense to knowingly sell or distribute a product containing a hemp-derived cannabinoid without having first obtained proof of age from the purchaser or recipient.
• (2) It is an offense for a person to knowingly sell or distribute a product containing a hemp-derived cannabinoid to a person who is under twenty-one (21) years of age or to purchase a product containing a hemp-derived cannabinoid on behalf of a person who is under twenty-one (21) years of age.
• (3) It is an offense for a person to knowingly assist a person who is under twenty-one (21) years of age to purchase, acquire, receive, or attempt to purchase a product containing a hemp-derived cannabinoid.
• (4) It is an offense for a person who is under twenty-one (21) years of age to knowingly purchase, possess, or accept receipt of a product containing a hemp-derived cannabinoid or to knowingly present purported proof of age that is false, fraudulent, or not actually that person's for the purpose of purchasing or receiving a product containing a hemp-derived cannabinoid.
• (5) This subsection (b) does not preclude law enforcement efforts involving:
• (A) The use of a minor if the minor's parent or legal guardian has consented to this action; or
• (B) The use of a person under twenty-one (21) years of age who is not a minor if the individual has consented to this action.
• (c) It is an offense to knowingly distribute samples of products containing a hemp-derived cannabinoid in or on a public street, sidewalk, or park.
• (d) A violation of this section is a Class A misdemeanor.
• (e) Notwithstanding this part to the contrary and except as provided in § 43-27-205, state and local law enforcement officers have concurrent jurisdiction to enforce violations of this section and § 43-27-204.

Tenn. Code Ann. § 43-27-203 “[Effective 7/1/2024] License required for manufacturing, producing, or selling hemp - derived cannabinoid products - Offenses and penalties”

• (a)
• (1) It is an offense for a person or entity to engage in the business of manufacturing, producing, or selling products containing a hemp-derived cannabinoid in this state without a valid license required by this part.
• (2) A product containing a hemp-derived cannabinoid that is sold or offered for sale in violation of subdivision (a)(1) is subject to seizure and forfeiture pursuant to § 53-11-451.
• (b)
• (1) It is an offense to knowingly sell or distribute a product containing a hemp-derived cannabinoid without having first obtained proof of age from the purchaser or recipient.
• (2) It is an offense for a person to knowingly sell or distribute a product containing a hemp-derived cannabinoid to a person who is under twenty-one (21) years of age or to purchase a product containing a hemp-derived cannabinoid on behalf of a person who is under twenty-one (21) years of age.
• (3) It is an offense for a person to knowingly assist a person who is under twenty-one (21) years of age to purchase, acquire, receive, or attempt to purchase a product containing a hemp-derived cannabinoid.
• (4) It is an offense for a person who is under twenty-one (21) years of age to knowingly purchase, possess, or accept receipt of a product containing a hemp-derived cannabinoid or to knowingly present purported proof of age that is false, fraudulent, or not actually that person's for the purpose of purchasing or receiving a product containing a hemp-derived cannabinoid.
• (5) This subsection (b) does not preclude law enforcement efforts involving:
• (A) The use of a minor if the minor's parent or legal guardian has consented to this action; or
• (B) The use of a person under twenty-one (21) years of age who is not a minor if the individual has consented to this action.
• (c) It is an offense to knowingly distribute samples of products containing a hemp-derived cannabinoid in or on a public street, sidewalk, or park.
• (d) A violation of this section is a Class A misdemeanor.
• (e) Notwithstanding this part to the contrary and except as provided in § 43-27-205, state and local law enforcement officers have concurrent jurisdiction to enforce violations of this section and § 43-27-204.

Tenn. Code Ann. § 43-27-204 “Maintenance of hemp derived cannabinoids in retail establishments - Violations”

• (a) As used in this section:
• (1) "Counter" means the point of purchase at a retail establishment; and
• (2) "Retail establishment" means a place of business open to the general public for the sale of goods or services and does not include a place of business for which entry is limited to persons twenty-one (21) years of age or older.
• (b) A product containing a hemp-derived cannabinoid must be maintained behind the counter of a retail establishment in an area inaccessible to a customer.
• (c) A violation of this section is a Class A misdemeanor.

Tenn. Code Ann. § 43-27-205 “[Effective 7/1/2024] Responsibilities of the department of agriculture - Responsibilities of the department of revenue - Annual reports”

1. (a) The department of agriculture is responsible for:
2. (1) Issuing licenses to suppliers and retailers under this part;
3. (2) Overseeing the manufacture and distribution of hemp-derived cannabinoid products by licensed suppliers, including ensuring compliance with labeling, product testing, and transportation requirements and conducting necessary inspections, prior to a product's delivery or sale to a retailer; and
4. (3) Conducting random, unannounced inspections at locations where hemp-derived cannabinoids and products containing hemp-derived cannabinoids are manufactured, distributed, or sold to ensure compliance with this part.
5. (b) The department of revenue:
6. (1) Is responsible for ensuring retailers are in compliance with this part and applicable tax provisions under title 67, including § 67-6-232;
7. (2) Shall enforce this part in a manner that may reasonably be expected to reduce the extent to which non-compliant hemp-derived cannabinoid products are sold and shall conduct random, unannounced inspections at retail locations where such products are sold to ensure compliance with this part. The department of revenue shall determine the frequency of random, unannounced inspections required under this subdivision (b)(2); and
8. (3) Is authorized to confiscate non-compliant hemp-derived cannabinoid products as contraband in the manner described in title 53, chapter 11. All products that the department of revenue confiscates under this subdivision (b)(3) are subject to seizure and forfeiture pursuant to § 53-11-451.
9. (c) Each department shall submit an annual report to the general assembly describing in detail the department's compliance and enforcement efforts under this part. The report must also be published and made available to the public on each department's website.

Tenn. Code. Ann. § 43-27-206 “[Effective 7/1/2024] License to produce or sell cannabinoid products - License requirements - Prohibited retail locations - Authority of the department of agriculture”

• (a) A person or entity that is in the business of manufacturing or selling products containing a hemp-derived cannabinoid in this state, including as a supplier or retailer, must obtain a license from the department of agriculture authorizing the person or entity to engage in that business prior to the commencement of business or by July 1, 2024, whichever is later.
• (b)
• (1) In order to obtain and maintain a supplier or retailer license under subsection (a), a person must:
• (A) Submit to the department of agriculture information prescribed by rules as necessary for the efficient enforcement of this part;
• (B) Pay to the department of agriculture a fee of five hundred dollars ($500) for supplier or two hundred fifty dollars ($250) per retailer per location;
• (C) Consent to reasonable inspection and sampling by the department of agriculture, or the department of revenue as applicable, of the person's inventory of products containing a hemp-derived cannabinoid; and
• (D) Submit to a criminal history background check that includes fingerprint checks against state and federal criminal records maintained by the Tennessee bureau of investigation and the federal bureau of investigation.
• (2) A person is not eligible to obtain or maintain a supplier or retailer license while serving a sentence for, or for ten (10) years following the date of conviction for, a drug-related felony offense in any state or federal jurisdiction.
• (3)
• (A) A retail location that is within one thousand feet (1,000') of a private school, public school, or charter school that serves any grades from kindergarten through grade twelve (K-12) shall not sell products containing a hemp-derived cannabinoid, unless the applicant provides the department with documentation that establishes that products containing a hemp-derived cannabinoid were being offered for sale at retail at such location on December 31, 2023.
• (B) The department shall accept business records, photographs, and video recordings as documentation for purposes of determining whether an applicant qualifies for the exception in subdivision (b)(3)(A).
• (C) For the purposes of subdivision (b)(3)(A), measurements shall be made in a straight line in all directions, without regard to intervening structures or objects, from the nearest point on the property line of a parcel containing a retail establishment to the nearest point on the property line of a parcel containing a private school, public school, or charter school that serves any grades from kindergarten through grade twelve (K-12).
• (c) A license issued pursuant to this section is valid for a period of one (1) year and may be renewed annually. The department of agriculture shall charge an annual renewal fee equal to the initial licensing fee.
• (d) The department of agriculture is authorized to:
• (1) Determine requirements for and issue licenses for the manufacture or sale of products containing a hemp-derived cannabinoid in this state; and
• (2) Deny or revoke licenses and issue civil penalties in the following manner for each violation of this part, or a rule promulgated pursuant to this part, as follows:
• (A) One thousand dollars ($1,000) for a first violation;
• (B) Two thousand five hundred dollars ($2,500) for a second violation that occurs within two (2) years of the first violation;
• (C) Five thousand dollars ($5,000) for a third violation that occurs within two (2) years of the first violation;
• (D) Revocation of the license for a fourth violation that occurs within two (2) years of the first violation; and
• (E) Require retraining of all employees of the licensee under the supervision of the department in addition to the civil penalty imposed pursuant to subdivisions (d)(2)(A)-(C).
• (e) The revenue collected from fees established under subdivision (b)(1)(B) must be deposited in the Tennessee agriculture regulatory fund, created by § 43-1-701, and used exclusively for the administration of this part.
  

Tenn. Code Ann. § 43-27-207 “[Effective 7/1/2024] Product testing requirements - Department of agriculture maintenance of list of qualified testing laboratories”

• (a) Testing of products and substances must be conducted as follows:
• (1) Full-panel testing on all active cannabinoid molecules must be conducted prior to final production of products containing a hemp-derived cannabinoid; and
• (2) A potency test must be conducted on finished goods to confirm potency is consistent with stated potency on the packaging.
• (b)
• (1) A supplier or retailer must contract with a third-party laboratory to provide the testing required by subsection (a).
• (2) The department of agriculture is authorized to promulgate rules specifying which types of tests may be used to satisfy the requirements of subsection (a) and the qualifications for laboratories from which the department will accept test results.
• (c) Each batch manufactured must undergo testing and obtain a certificate of analysis by a third-party laboratory qualified under subsection (b).
• (d) The department of agriculture shall:
• (1) Promulgate rules specifying pass/fail action levels for safety and toxicity with respect to the testing required by subsection (a);
• (2) Maintain and post on its website a registry of testing laboratories that are qualified to test intermediate manufactured material and finished products containing a hemp-derived cannabinoid;
• (3) Develop an application and process by which qualifying laboratories are listed on its website. The application submitted by a potentially qualifying laboratory must include a sample certificate of analysis issued by the applying laboratory; and
• (4) Sample and analyze products containing a hemp-derived cannabinoid produced, distributed, or offered for sale in this state for cannabinoid concentrations, tested according to protocols prescribed by rule under this part. Departmental testing methods must employ liquid chromatography tandem mass spectrometry, in a manner similarly reliable to post-decarboxylation, to determine a cannabinoid profile of samples tested, including their THC concentrations.
  

Tenn. Code Ann. § 43-27-208 “[Effective 7/1/2024] Transportation of hemp - derived cannabinoid products - Required documentation - Exceptions”

• (a) Except as provided in subsection (b), a person transporting products containing a hemp-derived cannabinoid into, within, or through this state shall carry:
• (1) Documentation sufficient to prove that the products being shipped or transported:
• (A) Were produced from hemp that was lawfully produced under a state or tribal hemp plan approved by the United States department of agriculture, under a hemp license issued by the United States department of agriculture, or otherwise in accordance with federal regulations through the state or territory of the Indian tribe, as applicable; and
• (B) Do not exceed the cannabinoid limits for hemp-derived cannabinoids; and
• (2) A bill of lading that includes:
• (A) Name and address of the owner of the products;
• (B) Point of origin;
• (C) Point of delivery, including name and address;
• (D) Kind and quantity of packages or, if in bulk, the total quantity of products in the shipment; and
• (E) Date of shipment.
• (b) Subsection (a) does not apply to a person in possession of products containing a hemp-derived cannabinoid that were purchased from a retailer that is licensed under this part.

Tenn. Code Ann. § 43-27-209 “[Effective 7/1/2024] Safety requirements for hemp - derived cannabinoid products - Proper storage by consumer - Prohibited advertising”

• (a) A product containing a hemp-derived cannabinoid that is sold at retail must:
• (1) Satisfy the child-resistant effectiveness standards under 16 CFR 1700.15(b)(1) when tested in accordance with the requirements of 16 CFR 1700.20; and
• (2) Be labeled with:
• (A) A list of ingredients and possible allergens and a nutritional fact panel;
• (B) A warning statement concerning the risk of impairment from consumption of the product, keeping the product out of the reach of children, and other warning information as required by rule of the department of agriculture;
• (C) If the product is ingestible, the amount of cannabinoid in each serving of the product, measured in milligrams;
• (D) The total amount of hemp-derived cannabinoid in the entire package, measured in milligrams;
• (E) The net weight of the product;
• (F) A quick response (QR) code that can be scanned to access a website providing the product's batch number, date received, date of completion, method of analysis for the testing report required under § 43-27-207, including information regarding results of the product's full-panel and potency tests conducted pursuant to § 43-27-207(a); and
• (G) An expiration date.
• (b) A person who obtains a product containing a hemp-derived cannabinoid that is sold at retail shall store any unconsumed portion of the product in its original packaging. It is a Class C misdemeanor offense for a person to violate this subsection (b).
• (c) A retailer or supplier of a product containing a hemp-derived cannabinoid shall not advertise, market, or offer for sale a product containing a hemp-derived cannabinoid by using, in the labeling or design of the product or product packaging or in advertising or marketing materials for the product trade dress, trademarks, branding, or other related imagery or scenery that depicts or signifies characters or symbols known to appeal primarily to persons under twenty-one (21) years of age, including, but not limited to, superheroes, comic book characters, video game characters, television show characters, movie characters, and unicorns or other mythical creatures.
• (d) An ingestible product containing a hemp-derived cannabinoid shall not:
• (1) Be sold in a serving that contains more than twenty-five (25) milligrams, in the aggregate, of one (1) or more hemp-derived cannabinoids; or
• (2) Be formed into the shape of an animal or cartoon character.
• (e) The department of agriculture is authorized to promulgate rules for the packaging, labeling, and display of products containing a hemp-derived cannabinoid that are offered for sale in this state.

Tenn. Code Ann. § 43-27-210 “[Effective 7/1/2024] Limitations on right to use hemp - derived cannabinoid - Rights of others”

• (a) This part does not permit a person to:
• (1) Undertake any task under the influence of a hemp-derived cannabinoid when doing so would constitute negligence or professional malpractice; or
• (2) Operate, navigate, or be in actual physical control of a motor vehicle, aircraft, motorized watercraft, or any other vehicle while under the influence of a hemp-derived cannabinoid.
• (b) This part does not require:
• (1) An employer to accommodate the use of a hemp-derived cannabinoid in a workplace or an employee working while under the influence of a hemp-derived cannabinoid;
• (2) An individual or establishment in lawful possession of property to allow a guest, client, customer, or other visitor to use a hemp-derived cannabinoid on or in that property; or
• (3) An individual or establishment in lawful possession of property to admit a guest, client, customer, or other visitor who is impaired as a result of the person's use of a hemp-derived cannabinoid.
• (c) This part does not exempt a person from prosecution for a criminal offense related to impairment or intoxication resulting from use of a hemp-derived cannabinoid or relieve a person from any requirement under law to submit to a breath, blood, urine, or other test to detect the presence of a controlled substance.
• (d) This part does not:
• (1) Limit the ability of an employer to establish, continue, or enforce a drug-free workplace program or policy;
• (2) Create a cause of action against an employer for wrongful discharge or discrimination; or
• (3) Allow the possession, sale, manufacture, or distribution of any substance that is otherwise prohibited by title 39, chapter 17, part 4.

Tenn. Code Ann. § 43-27-211 “[Effective 7/1/2024] Authority to promulgate rules”

The departments of agriculture and revenue are authorized to promulgate rules to effectuate this part in accordance with the Uniform Administrative Procedures Act, compiled in title 4, chapter 5.

RULES OF THE TENNESSEE DEPARTMENT OF AGRICULTURE

DIVISION OF CONSUMER AND INDUSTRY SERVICES

CHAPTER 0080-06-28 HEMP

0080-06-28-.01 SCOPE.

• (1) This chapter applies to any person who grows hemp.
• (2) Persons licensed under this chapter shall be responsible for operations conducted under their license until either the applicable license expires or the department receives written notification from the licensee desiring to terminate the license. The department shall not refund fees for early termination of any license issued under this chapter.
• (3) Licenses issued under this chapter are not transferable from person to person or location to location.
  

0080-06-28-.02 DEFINITIONS.

• (1) Terms in this chapter share those meanings of terms set forth in Section 12, Public Chapter 87 of 2019.
• (2) When used in this chapter, unless the context requires otherwise:
• (a) Act means Section 12, Public Chapter 87 of 2019;
• (b) Cannabis plant means any plant or any part of a plant of the genera Cannabis and includes hemp;
• (c) Grow means to cultivate plants with attached roots;
• (d) Growing area means any contiguous land area licensed for the growth of hemp. Bifurcation of a growing area by roads, fencing, or the like shall not render the area non-contiguous under this definition;
• (e) Move, distribute, transport, or similar words mean to relocate in any manner an item from one real property to another;
• (f) Person means an individual, partnership, corporation, or any other form of legal entity;
• (g) Sample means to take material or the material taken from a location licensed by the department;
• (h) Stop movement order means a written directive issued by the department to prohibit or limit the movement of plants or plant parts; and,
• (i) THC means delta-9 tetrahydrocannabinol.
  

0080-06-28-.02 DEFINITIONS.

• (1) A hemp license is required to possess rooted hemp and is issued to each person for each physical address where the person grows hemp.
• (2) Application for a license shall be made on forms provided by the department, which shall be completed in full and may include:
• (a) Name of applicant;
• (b) Date of birth of any applicant who is an individual or a partner in a general partnership;
• (c) Proof of one of the following for any applicant that is not an individual or a partner in a general partnership:
• 1. Applicant’s registration in its state of incorporation; or,
• 2. Applicant’s business license issued by a local governmental authority;
• (d) Contact information for applicant, to include name of person legally responsible for applicant’s operations, telephone number, email address, and address of the principal place of business;
• (e) Address of the location to be licensed for growth of hemp and description of all growing areas at the location, including total number of growing acres and Global Positioning System (GPS) coordinates from the areas’ central most points; and
• (f) Other information as required by the department.
• (3) Licensees shall notify the department of any changes to contact information of an application within 30 days after the change takes place.
• (4) The annual fee for a hemp license is assessed under T.C.A. § 43-1-703(f) and is determined according to the total size of growing area(s) at the licensed address: (a) Less than 5 acres: Tier 6 fee; (b) 5 acres to 20 acres: Tier 7 fee; (c) More than 20 acres: Tier 8 fee.
• (5) License applicants shall submit an application and license fee to the department on or before July 1 of each year. The annual license fee shall be waived for any institute of higher education that offers programs of study in agricultural sciences seeking licensure for a growing area on university property. Licenses expire on June 30 following their issuance. If an applicant for renewal fails to submit payment of the license fee on or before the following July 16, the applicant shall also be required to pay a late charge assessed under T.C.A. § 43- 1-703 prior to renewal of the license.
• (6) The department may deny any application for licensure that is not completed in accordance with this rule.
  

0080-06-28-.04 REPEALED.

0080-06-28-.05 CROP DISTRIBUTION AND DESTRUCTION.

• (1) Distribution. Licensees shall not distribute rooted hemp to an unlicensed person. Any person may possess, distribute, or store non-rooted hemp.
• (2) Destruction. Cannabis plants found to be in violation of the Act or this chapter shall be held from movement or destroyed in accordance with a departmental directive or destruction order.
• (3) Costs. Licensees shall pay all costs incurred for destruction of any cannabis plant or plant product.
  

0080-06-28-.06 MOVEMENT PERMITS.

• (1) Licensees shall not move rooted hemp plants without a valid movement permit issued by the department. Licensees shall also not move any hemp to anyone who treats or transforms harvested hemp for distribution in commerce without a valid movement permit issued by the department.
• (2) Hemp movement permits are required per vehicle per day. To receive a movement permit, the licensee shall submit a movement permit request on forms provided by the department, which may require:
• (a) The hemp license number for which movement is requested;
• (b) Origin and destination of movement;
• (c) Date of intended movement;
• (d) Weight, volume, or number of units of material to be moved.
• (3) The department may deny any application for a movement permit that is not completed in accordance with this rule.
• (4) Each cannabis plant or plant product moved not in conformity with this rule shall constitute a separate violation of this chapter.
  

0080-06-28-.07 SAMPLING AND INSPECTIONS.

• (1) Scope. The department may enter during normal business hours any location, licensed by the department, for purposes of inspecting any cannabis plant, record, or other material as necessary for the efficient enforcement of the Act and this chapter.
• (2) Sampling. The department may conduct sampling of any cannabis plant or other material at a location licensed by the department. A sample collected according to uniform protocols approved by the commissioner shall be deemed representative of the location, growing area, or lesser lot from which the sample was obtained. After the department obtains a sample, licensees shall not move any cannabis plant from the area represented by the sample until the department determines the sample tests no higher than 0.3% THC on a dry mass basis. 
• (3) Testing protocols. The procedure employed by the Tennessee Department of Agriculture defines the preparation of hemp samples for the determination of THC and is conducted in a manner similarly reliable to post-decarboxylation. The preparation steps include extraction and quantitation of cannabinoids. Cannabinoid quantitation is accomplished using liquid chromatography tandem mass spectrometry (LC-MS/MS). Cannabinoids that can be analyzed by this procedure include delta-9-tetrahydrocannabinol (Δ9 THC), tetrahydrocannabinolic acid A (THCA), cannabidiol (CBD), and cannabinol (CBN). The THC content of hemp samples is determined on a dry weight basis. Cannabinoids are extracted from test portions of prepared hemp samples by adding a suitable solvent and shaking the samples on a horizontal orbital shaker. Extracts are subsequently centrifuged, and an aliquot of the supernatant is taken for dilution. A portion of this diluted extract is transferred into an autosampler vial for analysis by LC-MS/MS. Quality Control samples are analyzed alongside unknown samples to demonstrate statistical control of the procedure.
•  (4) Test results exceeding 0.3% THC. Any sample test result higher than 0.3% THC concentration on a dry mass basis shall be conclusive evidence that one or more cannabis plants or plant products from the area sampled contain a THC concentration in excess of that allowed under the Act and shall be grounds for stop movement and destruction orders for any plant within the sampled area.
• (5) Destruction. Destruction of any plants or plant products under this rule shall be performed in accordance with a directive from the department, which may include destruction by any means necessary for reasonable assurance that all cannabis plants exceeding allowable limits of THC are destroyed, e.g. by removal and incineration, field burning, deep burial, composting, or other means approved by the department. Any licensee aggrieved by an order issued under this chapter may petition the department in writing for review of the order under the Uniform Administrative Procedures Act. If no petition is filed with the department within ten days of the department’s order, the order shall become final and will not be subject to review.
• (6) Laboratory analysis costs. Licensees shall pay a Tier 4 laboratory analysis fee under T.C.A. § 43-1-703(f) for each sample collected by the department.
  

0080-06-28-.08 REPEALED.

0080-06-28-.09 VIOLATIONS.

• (1) In addition to other requirements of this chapter, licensees shall: (a) Possess or grow rooted hemp only within a licensed growing area or under immediate transport to a licensed growing area; and, (b) Upon departmental request, provide full and accurate information regarding the person’s acquisition, cultivation, and distribution of hemp.
• (2) In addition to other requirements of this chapter, licensees shall not:
• (a) Be convicted of any drug-related felony offense in any state or federal jurisdiction within the previous ten years. Violation of this provision is grounds for immediate denial or revocation of any license issued under this chapter;
• (b) Cultivate, move, or distribute cannabis plants other than hemp;
• (c) Interfere with an authorized representative of the department in the performance of his duties;  
• (d) Market or represent hemp or hemp products to be marijuana or any illicit substance in any form; or,
• (e) Violate any state or federal quarantine or order issued by the department.
• (3) A person is responsible for violations of the Act or this chapter when committed by either the person or his agent.
• (4) Each violation of the Act or this chapter is grounds for issuance of stop movement or destruction orders against any cannabis plant held by the violator or his agent; denial or revocation of any license issued under this chapter; actions for injunction; imposition of civil penalties; or referral for criminal investigation pursuant to the Act.
  

CBD

MARIJUANA

Tenn. Code Ann. 39-17-402 (16) Marijuana

• (a) "Marijuana" means all parts of the plant cannabis, whether growing or not; the seeds of the plant; the resin extracted from any part of the plant; and every compound, manufacture, salt, derivative, mixture, or preparation of the plant, including concentrates and oils, its seeds or resin;
• (b) "Marijuana" does not include the mature stalks of the plant, fiber produced from the stalks, oil or cake made from the seeds of the plant, any other compound, manufacture, salt, derivative, mixture, or preparation of the mature stalks, except the resin extracted from the mature stalks, fiber, oil, or cake, or the sterilized seeds of the plant which are incapable of germination;
• (c) "Marijuana" also does not include hemp, as defined in § 43-27-101;
• (d) The term "marijuana" does not include a cannabidiol product approved as a prescription medication by the United States food and drug administration;
• (e) The term "marijuana" does not include cannabis oil containing the substance cannabidiol, with less than six tenths of one percent (0.6%) of tetrahydrocannabinol, including the necessary seeds and plants, when manufactured, processed, transferred, dispensed, or possessed by a four-year public or private institution of higher education certified by the drug enforcement administration located in the state as part of a clinical research study on the treatment of intractable seizures, cancer, or other diseases; and
• (f) The term "marijuana" does not include oil containing the substance cannabidiol, with less than nine-tenths of one percent (0.9%) of tetrahydrocannabinol, if:
• (i)  The bottle containing the oil is labeled by the manufacturer as containing cannabidiol in an amount less than nine-tenths of one percent (0.9%) of tetrahydrocannabinol; and
• (ii)  The person in possession of the oil retains:
• (a)  Proof of the legal order or recommendation from the issuing state; and
• (b)  Proof that the person or the person's immediate family member has been diagnosed with intractable seizures or epilepsy by a medical doctor or doctor of osteopathic medicine who is licensed to practice medicine in the state of Tennessee.

This information is for educational purposes only and is not to be considered legal advice. Prior to relying on this information, please contact one of our attorneys for a consultation.

GOOD MANUFACTURING PRACTICES - 21 CFR 117

• Acid foods or acidified foods — means foods that have an equilibrium pH of 4.6 or below.
• Adequate — means that which is needed to accomplish the intended purpose in keeping with good public health practice.
• Affiliate — means any facility that controls, is controlled by, or is under common control with another facility.
• Allergen cross-contact — means the unintentional incorporation of a food allergen into a food.
• Audit — means the systematic, independent, and documented examination (through observation, investigation, records review, discussions with employees of the audited entity, and, as appropriate, sampling and laboratory analysis) to assess an audited entity's food safety processes and procedures.
• Batter — means a semifluid substance, usually composed of flour and other ingredients, into which principal components of food are dipped or with which they are coated, or which may be used directly to form bakery foods.
• Blanching — except for tree nuts and peanuts, means a prepackaging heat treatment of foodstuffs for an adequate time and at an adequate temperature to partially or completely inactivate the naturally occurring enzymes and to effect other physical or biochemical changes in the food.
• Calendar day — means every day shown on the calendar.
• Correction — means an action to identify and correct a problem that occurred during the production of food, without other actions associated with a corrective action procedure (such as actions to reduce the likelihood that the problem will recur, evaluate all affected food for safety, and prevent affected food from entering commerce).
• Critical control point — means a point, step, or procedure in a food process at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce such hazard to an acceptable level.
• Defect action level — means a level of a non-hazardous, naturally occurring, unavoidable defect at which FDA may regard a food product “adulterated” and subject to enforcement action under section 402(a)(3) of the Federal Food, Drug, and Cosmetic Act.
• Environmental pathogen — means a pathogen capable of surviving and persisting within the manufacturing, processing, packing, or holding environment such that food may be contaminated and may result in foodborne illness if that food is consumed without treatment to significantly minimize the environmental pathogen. Examples of environmental pathogens for the purposes of this part include Listeria monocytogenes and Salmonella spp. but do not include the spores of pathogenic sporeforming bacteria.
• Facility — means a domestic facility or a foreign facility that is required to register under section 415 of the Federal Food, Drug, and Cosmetic Act, in accordance with the requirements of part 1, subpart H of this chapter.
• Farm — means farm as defined in § 1.227 of this chapter.
• FDA means the Food and Drug Administration.
• Food — means food as defined in section 201(f) of the Federal Food, Drug, and Cosmetic Act and includes raw materials and ingredients.
• Food allergen — means a major food allergen as defined in section 201(qq) of the Federal Food, Drug, and Cosmetic Act.
• Food-contact surfaces — are those surfaces that contact human food and those surfaces from which drainage, or other transfer, onto the food or onto surfaces that contact the food ordinarily occurs during the normal course of operations. “Food-contact surfaces” includes utensils and food-contact surfaces of equipment.
• Full-time equivalent employee — is a term used to represent the number of employees of a business entity for the purpose of determining whether the business qualifies for the small business exemption. The number of full-time equivalent employees is determined by dividing the total number of hours of salary or wages paid directly to employees of the business entity and of all of its affiliates and subsidiaries by the number of hours of work in 1 year, 2,080 hours (i.e., 40 hours × 52 weeks). If the result is not a whole number, round down to the next lowest whole number.
• Harvesting — applies to farms and farm mixed-type facilities and means activities that are traditionally performed on farms for the purpose of removing raw agricultural commodities from the place they were grown or raised and preparing them for use as food. Harvesting is limited to activities performed on raw agricultural commodities, or on processed foods created by drying/dehydrating a raw agricultural commodity without additional manufacturing/processing, on a farm. Harvesting does not include activities that transform a raw agricultural commodity into a processed food as defined in section 201(gg) of the Federal Food, Drug, and Cosmetic Act. Examples of harvesting include cutting (or otherwise separating) the edible portion of the raw agricultural commodity from the crop plant and removing or trimming part of the raw agricultural commodity (e.g., foliage, husks, roots or stems). Examples of harvesting also include cooling, field coring, filtering, gathering, hulling, shelling, sifting, threshing, trimming of outer leaves of, and washing raw agricultural commodities grown on a farm.
• Hazard — means any biological, chemical (including radiological), or physical agent that has the potential to cause illness or injury.
• Hazard requiring a preventive control — means a known or reasonably foreseeable hazard for which a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would, based on the outcome of a hazard analysis (which includes an assessment of the severity of the illness or injury if the hazard were to occur and the probability that the hazard will occur in the absence of preventive controls), establish one or more preventive controls to significantly minimize or prevent the hazard in a food and components to manage those controls (such as monitoring, corrections or corrective actions, verification, and records) as appropriate to the food, the facility, and the nature of the preventive control and its role in the facility's food safety system.
• Holding — means storage of food and also includes activities performed incidental to storage of a food (e.g., activities performed for the safe or effective storage of that food, such as fumigating food during storage, and drying/dehydrating raw agricultural commodities when the drying/dehydrating does not create a distinct commodity (such as drying/dehydrating hay or alfalfa)). Holding also includes activities performed as a practical necessity for the distribution of that food (such as blending of the same raw agricultural commodity and breaking down pallets), but does not include activities that transform a raw agricultural commodity into a processed food as defined in section 201(gg) of the Federal Food, Drug, and Cosmetic Act. Holding facilities could include warehouses, cold storage facilities, storage silos, grain elevators, and liquid storage tanks.
• Known or reasonably foreseeable hazard — means a biological, chemical (including radiological), or physical hazard that is known to be, or has the potential to be, associated with the facility or the food.
• Lot — means the food produced during a period of time and identified by an establishment's specific code.
• Manufacturing/processing — means making food from one or more ingredients, or synthesizing, preparing, treating, modifying or manipulating food, including food crops or ingredients. Examples of manufacturing/processing activities include: Baking, boiling, bottling, canning, cooking, cooling, cutting, distilling, drying/dehydrating raw agricultural commodities to create a distinct commodity (such as drying/dehydrating grapes to produce raisins), evaporating, eviscerating, extracting juice, formulating, freezing, grinding, homogenizing, irradiating, labeling, milling, mixing, packaging (including modified atmosphere packaging), pasteurizing, peeling, rendering, treating to manipulate ripening, trimming, washing, or waxing. For farms and farm mixed-type facilities, manufacturing/processing does not include activities that are part of harvesting, packing, or holding.
• Microorganisms — means yeasts, molds, bacteria, viruses, protozoa, and microscopic parasites and includes species that are pathogens. The term “undesirable microorganisms” includes those microorganisms that are pathogens, that subject food to decomposition, that indicate that food is contaminated with filth, or that otherwise may cause food to be adulterated.
• Mixed-type facility — means an establishment that engages in both activities that are exempt from registration under section 415 of the Federal Food, Drug, and Cosmetic Act and activities that require the establishment to be registered. An example of such a facility is a “farm mixed-type facility,” which is an establishment that is a farm, but also conducts activities outside the farm definition that require the establishment to be registered.
• Monitor — means to conduct a planned sequence of observations or measurements to assess whether control measures are operating as intended.
• Packing — means placing food into a container other than packaging the food and also includes re-packing and activities performed incidental to packing or re-packing a food (e.g., activities performed for the safe or effective packing or re-packing of that food (such as sorting, culling, grading, and weighing or conveying incidental to packing or re-packing)), but does not include activities that transform a raw agricultural commodity into a processed food as defined in section 201(gg) of the Federal Food, Drug, and Cosmetic Act.
• Pathogen — means a microorganism of public health significance.
• Pest — refers to any objectionable animals or insects including birds, rodents, flies, and larvae.
• Plant — means the building or structure or parts thereof, used for or in connection with the manufacturing, processing, packing, or holding of human food.
• Preventive controls — means those risk-based, reasonably appropriate procedures, practices, and processes that a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would employ to significantly minimize or prevent the hazards identified under the hazard analysis that are consistent with the current scientific understanding of safe food manufacturing, processing, packing, or holding at the time of the analysis.
• Preventive controls qualified individual — means a qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety system.
• Qualified auditor — means a person who is a qualified individual as defined in this part and has technical expertise obtained through education, training, or experience (or a combination thereof) necessary to perform the auditing function as required by § 117.180(c)(2). Examples of potential qualified auditors include:
• (1) A government employee, including a foreign government employee; and
• (2) An audit agent of a certification body that is accredited in accordance with regulations in part 1, subpart M of this chapter.
• Qualified end-user — with respect to a food, means the consumer of the food (where the term consumer does not include a business); or a restaurant or retail food establishment (as those terms are defined in § 1.227 of this chapter) that:
• (1) Is located:
• (i) In the same State or the same Indian reservation as the qualified facility that sold the food to such restaurant or establishment; or
• (ii) Not more than 275 miles from such facility; and
• (2) Is purchasing the food for sale directly to consumers at such restaurant or retail food establishment.
• Qualified facility — means (when including the sales by any subsidiary; affiliate; or subsidiaries or affiliates, collectively, of any entity of which the facility is a subsidiary or affiliate) a facility that is a very small business as defined in this part, or a facility to which both of the following apply:
• (1) During the 3-year period preceding the applicable calendar year, the average annual monetary value of the food manufactured, processed, packed or held at such facility that is sold directly to qualified end-users (as defined in this part) during such period exceeded the average annual monetary value of the food sold by such facility to all other purchasers; and
• (2) The average annual monetary value of all food sold during the 3-year period preceding the applicable calendar year was less than $500,000, adjusted for inflation.
• Qualified facility exemption — means an exemption applicable to a qualified facility under § 117.5(a).
• Qualified individual — means a person who has the education, training, or experience (or a combination thereof) necessary to manufacture, process, pack, or hold clean and safe food as appropriate to the individual's assigned duties. A qualified individual may be, but is not required to be, an employee of the establishment.
• Quality control operation — means a planned and systematic procedure for taking all actions necessary to prevent food from being adulterated.
• Raw agricultural commodity — has the meaning given in section 201(r) of the Federal Food, Drug, and Cosmetic Act.
• Ready-to-eat food (RTE food) — means any food that is normally eaten in its raw state or any other food, including a processed food, for which it is reasonably foreseeable that the food will be eaten without further processing that would significantly minimize biological hazards.
• Receiving facility — means a facility that is subject to subparts C and G of this part and that manufactures/processes a raw material or other ingredient that it receives from a supplier.
• Rework — means clean, unadulterated food that has been removed from processing for reasons other than insanitary conditions or that has been successfully reconditioned by reprocessing and that is suitable for use as food.
• Safe-moisture level — is a level of moisture low enough to prevent the growth of undesirable microorganisms in the finished product under the intended conditions of manufacturing, processing, packing, and holding. The safe moisture level for a food is related to its water activity (a_w). An a_w will be considered safe for a food if adequate data are available that demonstrate that the food at or below the given a_w will not support the growth of undesirable microorganisms.
• Sanitize — means to adequately treat cleaned surfaces by a process that is effective in destroying vegetative cells of pathogens, and in substantially reducing numbers of other undesirable microorganisms, but without adversely affecting the product or its safety for the consumer.
• Significantly minimize — means to reduce to an acceptable level, including to eliminate.
• Small business — means, for purposes of this part, a business (including any subsidiaries and affiliates) employing fewer than 500 full-time equivalent employees.
• Subsidiary — means any company which is owned or controlled directly or indirectly by another company.
• Supplier — means the establishment that manufactures/processes the food, raises the animal, or grows the food that is provided to a receiving facility without further manufacturing/processing by another establishment, except for further manufacturing/processing that consists solely of the addition of labeling or similar activity of a de minimis nature.
• Supply-chain-applied control — means a preventive control for a hazard in a raw material or other ingredient when the hazard in the raw material or other ingredient is controlled before its receipt.
• Unexposed packaged food — means packaged food that is not exposed to the environment.
• Validation — means obtaining and evaluating scientific and technical evidence that a control measure, combination of control measures, or the food safety plan as a whole, when properly implemented, is capable of effectively controlling the identified hazards.
• Verification — means the application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine whether a control measure or combination of control measures is or has been operating as intended and to establish the validity of the food safety plan.
• Very small business — means, for purposes of this part, a business (including any subsidiaries and affiliates) averaging less than $1,000,000, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed, or held without sale (e.g., held for a fee).
• Water activity — (a_w) is a measure of the free moisture in a food and is the quotient of the water vapor pressure of the substance divided by the vapor pressure of pure water at the same temperature.
• Written procedures for receiving raw materials and other ingredients — means written procedures to ensure that raw materials and other ingredients are received only from suppliers approved by the receiving facility (or, when necessary and appropriate, on a temporary basis from unapproved suppliers whose raw materials or other ingredients are subjected to adequate verification activities before acceptance for use).
• You — means, for purposes of this part, the owner, operator, or agent in charge of a facility. 

• (a) Applicability.
• (1) The management of an establishment must ensure that all individuals who manufacture, process, pack, or hold food subject to subparts B and F of this part are qualified to perform their assigned duties.
• (2) The owner, operator, or agent in charge of a facility must ensure that all individuals who manufacture, process, pack, or hold food subject to subpart C, D, E, F, or G of this part are qualified to perform their assigned duties.
• (b) Qualifications of all individuals engaged in manufacturing, processing, packing, or holding food. Each individual engaged in manufacturing, processing, packing, or holding food (including temporary and seasonal personnel) or in the supervision thereof must:
• (1) Be a qualified individual as that term is defined in § 117.3 - i.e., have the education, training, or experience (or a combination thereof) necessary to manufacture, process, pack, or hold clean and safe food as appropriate to the individual's assigned duties; and
• (2) Receive training in the principles of food hygiene and food safety, including the importance of employee health and personal hygiene, as appropriate to the food, the facility and the individual's assigned duties.
• (c) Additional qualifications of supervisory personnel. Responsibility for ensuring compliance by individuals with the requirements of this part must be clearly assigned to supervisory personnel who have the education, training, or experience (or a combination thereof) necessary to supervise the production of clean and safe food.
• (d) Records. Records that document training required by paragraph (b)(2) of this section must be established and maintained. 



• (a) Records that document training required by § 117.4(b)(2) must be established and maintained.
• (b) The records that must be established and maintained are subject to the requirements of subpart F of this part.



• (a) Disease control. Any person who, by medical examination or supervisory observation, is shown to have, or appears to have, an illness, open lesion, including boils, sores, or infected wounds, or any other abnormal source of microbial contamination by which there is a reasonable possibility of food, food-contact surfaces, or food-packaging materials becoming contaminated, must be excluded from any operations which may be expected to result in such contamination until the condition is corrected, unless conditions such as open lesions, boils, and infected wounds are adequately covered (e.g., by an impermeable cover). Personnel must be instructed to report such health conditions to their supervisors.
• (b) Cleanliness. All persons working in direct contact with food, food-contact surfaces, and food-packaging materials must conform to hygienic practices while on duty to the extent necessary to protect against allergen cross-contact and against contamination of food. The methods for maintaining cleanliness include:
• (1) Wearing outer garments suitable to the operation in a manner that protects against allergen cross-contact and against the contamination of food, food-contact surfaces, or food-packaging materials.
• (2) Maintaining adequate personal cleanliness.
• (3) Washing hands thoroughly (and sanitizing if necessary to protect against contamination with undesirable microorganisms) in an adequate hand-washing facility before starting work, after each absence from the work station, and at any other time when the hands may have become soiled or contaminated.
• (4) Removing all unsecured jewelry and other objects that might fall into food, equipment, or containers, and removing hand jewelry that cannot be adequately sanitized during periods in which food is manipulated by hand. If such hand jewelry cannot be removed, it may be covered by material which can be maintained in an intact, clean, and sanitary condition and which effectively protects against the contamination by these objects of the food, food-contact surfaces, or food-packaging materials.
• (5) Maintaining gloves, if they are used in food handling, in an intact, clean, and sanitary condition.
• (6) Wearing, where appropriate, in an effective manner, hair nets, headbands, caps, beard covers, or other effective hair restraints.
• (7) Storing clothing or other personal belongings in areas other than where food is exposed or where equipment or utensils are washed.
• (8) Confining the following to areas other than where food may be exposed or where equipment or utensils are washed: eating food, chewing gum, drinking beverages, or using tobacco.
• (9) Taking any other necessary precautions to protect against allergen cross-contact and against contamination of food, food-contact surfaces, or food-packaging materials with microorganisms or foreign substances (including perspiration, hair, cosmetics, tobacco, chemicals, and medicines applied to the skin). 

• (a) Grounds. The grounds about a food plant under the control of the operator must be kept in a condition that will protect against the contamination of food. The methods for adequate maintenance of grounds must include:
• (1) Properly storing equipment, removing litter and waste, and cutting weeds or grass within the immediate vicinity of the plant that may constitute an attractant, breeding place, or harborage for pests.
• (2) Maintaining roads, yards, and parking lots so that they do not constitute a source of contamination in areas where food is exposed.
• (3) Adequately draining areas that may contribute contamination to food by seepage, foot-borne filth, or providing a breeding place for pests.
• (4) Operating systems for waste treatment and disposal in an adequate manner so that they do not constitute a source of contamination in areas where food is exposed.
• (5) If the plant grounds are bordered by grounds not under the operator's control and not maintained in the manner described in paragraphs (a)(1) through (4) of this section, care must be exercised in the plant by inspection, extermination, or other means to exclude pests, dirt, and filth that may be a source of food contamination.
• (b) Plant construction and design. The plant must be suitable in size, construction, and design to facilitate maintenance and sanitary operations for food-production purposes (i.e., manufacturing, processing, packing, and holding). The plant must:
• (1) Provide adequate space for such placement of equipment and storage of materials as is necessary for maintenance, sanitary operations, and the production of safe food.
• (2) Permit the taking of adequate precautions to reduce the potential for allergen cross-contact and for contamination of food, food-contact surfaces, or food-packaging materials with microorganisms, chemicals, filth, and other extraneous material. The potential for allergen cross-contact and for contamination may be reduced by adequate food safety controls and operating practices or effective design, including the separation of operations in which allergen cross-contact and contamination are likely to occur, by one or more of the following means: location, time, partition, air flow systems, dust control systems, enclosed systems, or other effective means.
• (3) Permit the taking of adequate precautions to protect food in installed outdoor bulk vessels by any effective means, including:
• (i) Using protective coverings.
• (ii) Controlling areas over and around the vessels to eliminate harborages for pests.
• (iii) Checking on a regular basis for pests and pest infestation.
• (iv) Skimming fermentation vessels, as necessary.
• (4) Be constructed in such a manner that floors, walls, and ceilings may be adequately cleaned and kept clean and kept in good repair; that drip or condensate from fixtures, ducts and pipes does not contaminate food, food-contact surfaces, or food-packaging materials; and that aisles or working spaces are provided between equipment and walls and are adequately unobstructed and of adequate width to permit employees to perform their duties and to protect against contaminating food, food-contact surfaces, or food-packaging materials with clothing or personal contact.
• (5) Provide adequate lighting in hand-washing areas, dressing and locker rooms, and toilet rooms and in all areas where food is examined, manufactured, processed, packed, or held and where equipment or utensils are cleaned; and provide shatter-resistant light bulbs, fixtures, skylights, or other glass suspended over exposed food in any step of preparation or otherwise protect against food contamination in case of glass breakage.
• (6) Provide adequate ventilation or control equipment to minimize dust, odors and vapors (including steam and noxious fumes) in areas where they may cause allergen cross-contact or contaminate food; and locate and operate fans and other air-blowing equipment in a manner that minimizes the potential for allergen cross-contact and for contaminating food, food-packaging materials, and food-contact surfaces.
• (7) Provide, where necessary, adequate screening or other protection against pests. 

• (a) General maintenance. Buildings, fixtures, and other physical facilities of the plant must be maintained in a clean and sanitary condition and must be kept in repair adequate to prevent food from becoming adulterated. Cleaning and sanitizing of utensils and equipment must be conducted in a manner that protects against allergen cross-contact and against contamination of food, food-contact surfaces, or food-packaging materials.
• (b) Substances used in cleaning and sanitizing; storage of toxic materials.
• (1) Cleaning compounds and sanitizing agents used in cleaning and sanitizing procedures must be free from undesirable microorganisms and must be safe and adequate under the conditions of use. Compliance with this requirement must be verified by any effective means, including purchase of these substances under a letter of guarantee or certification or examination of these substances for contamination. Only the following toxic materials may be used or stored in a plant where food is processed or exposed:
• (i) Those required to maintain clean and sanitary conditions;
• (ii) Those necessary for use in laboratory testing procedures;
• (iii) Those necessary for plant and equipment maintenance and operation; and
• (iv) Those necessary for use in the plant's operations.
• (2) Toxic cleaning compounds, sanitizing agents, and pesticide chemicals must be identified, held, and stored in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials.
• (c) Pest control. Pests must not be allowed in any area of a food plant. Guard, guide, or pest-detecting dogs may be allowed in some areas of a plant if the presence of the dogs is unlikely to result in contamination of food, food-contact surfaces, or food-packaging materials. Effective measures must be taken to exclude pests from the manufacturing, processing, packing, and holding areas and to protect against the contamination of food on the premises by pests. The use of pesticides to control pests in the plant is permitted only under precautions and restrictions that will protect against the contamination of food, food-contact surfaces, and food-packaging materials.
• (d) Sanitation of food-contact surfaces. All food-contact surfaces, including utensils and food-contact surfaces of equipment, must be cleaned as frequently as necessary to protect against allergen cross-contact and against contamination of food.
• (1) Food-contact surfaces used for manufacturing/processing, packing, or holding low-moisture food must be in a clean, dry, sanitary condition before use. When the surfaces are wet-cleaned, they must, when necessary, be sanitized and thoroughly dried before subsequent use.
• (2) In wet processing, when cleaning is necessary to protect against allergen cross-contact or the introduction of microorganisms into food, all food-contact surfaces must be cleaned and sanitized before use and after any interruption during which the food-contact surfaces may have become contaminated. Where equipment and utensils are used in a continuous production operation, the utensils and food-contact surfaces of the equipment must be cleaned and sanitized as necessary.
• (3) Single-service articles (such as utensils intended for one-time use, paper cups, and paper towels) must be stored, handled, and disposed of in a manner that protects against allergen cross-contact and against contamination of food, food-contact surfaces, or food-packaging materials.
• (e) Sanitation of non-food-contact surfaces. Non-food-contact surfaces of equipment used in the operation of a food plant must be cleaned in a manner and as frequently as necessary to protect against allergen cross-contact and against contamination of food, food-contact surfaces, and food-packaging materials.
• (f) Storage and handling of cleaned portable equipment and utensils. Cleaned and sanitized portable equipment with food-contact surfaces and utensils must be stored in a location and manner that protects food-contact surfaces from allergen cross-contact and from contamination. 

Each plant must be equipped with adequate sanitary facilities and accommodations including: 

• (a) Water supply. The water supply must be adequate for the operations intended and must be derived from an adequate source. Any water that contacts food, food-contact surfaces, or food-packaging materials must be safe and of adequate sanitary quality. Running water at a suitable temperature, and under pressure as needed, must be provided in all areas where required for the processing of food, for the cleaning of equipment, utensils, and food-packaging materials, or for employee sanitary facilities.
• (b) Plumbing. Plumbing must be of adequate size and design and adequately installed and maintained to:
• (1) Carry adequate quantities of water to required locations throughout the plant.
• (2) Properly convey sewage and liquid disposable waste from the plant.
• (3) Avoid constituting a source of contamination to food, water supplies, equipment, or utensils or creating an unsanitary condition.
• (4) Provide adequate floor drainage in all areas where floors are subject to flooding-type cleaning or where normal operations release or discharge water or other liquid waste on the floor.
• (5) Provide that there is not backflow from, or cross-connection between, piping systems that discharge waste water or sewage and piping systems that carry water for food or food manufacturing.
• (c) Sewage disposal. Sewage must be disposed of into an adequate sewerage system or disposed of through other adequate means.
• (d) Toilet facilities. Each plant must provide employees with adequate, readily accessible toilet facilities. Toilet facilities must be kept clean and must not be a potential source of contamination of food, food-contact surfaces, or food-packaging materials.
• (e) Hand-washing facilities. Each plant must provide hand-washing facilities designed to ensure that an employee's hands are not a source of contamination of food, food-contact surfaces, or food-packaging materials, by providing facilities that are adequate, convenient, and furnish running water at a suitable temperature.
• (f) Rubbish and offal disposal. Rubbish and any offal must be so conveyed, stored, and disposed of as to minimize the development of odor, minimize the potential for the waste becoming an attractant and harborage or breeding place for pests, and protect against contamination of food, food-contact surfaces, food-packaging materials, water supplies, and ground surfaces. 

• (a)
• (1) All plant equipment and utensils used in manufacturing, processing, packing, or holding food must be so designed and of such material and workmanship as to be adequately cleanable, and must be adequately maintained to protect against allergen cross-contact and contamination.
• (2) Equipment and utensils must be designed, constructed, and used appropriately to avoid the adulteration of food with lubricants, fuel, metal fragments, contaminated water, or any other contaminants.
• (3) Equipment must be installed so as to facilitate the cleaning and maintenance of the equipment and of adjacent spaces.
• (4) Food-contact surfaces must be corrosion-resistant when in contact with food.
• (5) Food-contact surfaces must be made of nontoxic materials and designed to withstand the environment of their intended use and the action of food, and, if applicable, cleaning compounds, sanitizing agents, and cleaning procedures.
• (6) Food-contact surfaces must be maintained to protect food from allergen cross-contact and from being contaminated by any source, including unlawful indirect food additives.
• (b) Seams on food-contact surfaces must be smoothly bonded or maintained so as to minimize accumulation of food particles, dirt, and organic matter and thus minimize the opportunity for growth of microorganisms and allergen cross-contact.
• (c) Equipment that is in areas where food is manufactured, processed, packed, or held and that does not come into contact with food must be so constructed that it can be kept in a clean and sanitary condition.
• (d) Holding, conveying, and manufacturing systems, including gravimetric, pneumatic, closed, and automated systems, must be of a design and construction that enables them to be maintained in an appropriate clean and sanitary condition.
• (e) Each freezer and cold storage compartment used to store and hold food capable of supporting growth of microorganisms must be fitted with an indicating thermometer, temperature-measuring device, or temperature-recording device so installed as to show the temperature accurately within the compartment.
• (f) Instruments and controls used for measuring, regulating, or recording temperatures, pH, acidity, water activity, or other conditions that control or prevent the growth of undesirable microorganisms in food must be accurate and precise and adequately maintained, and adequate in number for their designated uses.
• (g) Compressed air or other gases mechanically introduced into food or used to clean food-contact surfaces or equipment must be treated in such a way that food is not contaminated with unlawful indirect food additives. 

• (a) General.
• (1) All operations in the manufacturing, processing, packing, and holding of food (including operations directed to receiving, inspecting, transporting, and segregating) must be conducted in accordance with adequate sanitation principles.
• (2) Appropriate quality control operations must be employed to ensure that food is suitable for human consumption and that food-packaging materials are safe and suitable.
• (3) Overall sanitation of the plant must be under the supervision of one or more competent individuals assigned responsibility for this function.
• (4) Adequate precautions must be taken to ensure that production procedures do not contribute to allergen cross-contact and to contamination from any source.
• (5) Chemical, microbial, or extraneous-material testing procedures must be used where necessary to identify sanitation failures or possible allergen cross-contact and food contamination.
• (6) All food that has become contaminated to the extent that it is adulterated must be rejected, or if appropriate, treated or processed to eliminate the contamination.
• (b) Raw materials and other ingredients.
• (1) Raw materials and other ingredients must be inspected and segregated or otherwise handled as necessary to ascertain that they are clean and suitable for processing into food and must be stored under conditions that will protect against allergen cross-contact and against contamination and minimize deterioration. Raw materials must be washed or cleaned as necessary to remove soil or other contamination. Water used for washing, rinsing, or conveying food must be safe and of adequate sanitary quality. Water may be reused for washing, rinsing, or conveying food if it does not cause allergen cross-contact or increase the level of contamination of the food.
• (2) Raw materials and other ingredients must either not contain levels of microorganisms that may render the food injurious to the health of humans, or they must be pasteurized or otherwise treated during manufacturing operations so that they no longer contain levels that would cause the product to be adulterated.
• (3) Raw materials and other ingredients susceptible to contamination with aflatoxin or other natural toxins must comply with FDA regulations for poisonous or deleterious substances before these raw materials or other ingredients are incorporated into finished food.
• (4) Raw materials, other ingredients, and rework susceptible to contamination with pests, undesirable microorganisms, or extraneous material must comply with applicable FDA regulations for natural or unavoidable defects if a manufacturer wishes to use the materials in manufacturing food.
• (5) Raw materials, other ingredients, and rework must be held in bulk, or in containers designed and constructed so as to protect against allergen cross-contact and against contamination and must be held at such temperature and relative humidity and in such a manner as to prevent the food from becoming adulterated. Material scheduled for rework must be identified as such.
• (6) Frozen raw materials and other ingredients must be kept frozen. If thawing is required prior to use, it must be done in a manner that prevents the raw materials and other ingredients from becoming adulterated.
• (7) Liquid or dry raw materials and other ingredients received and stored in bulk form must be held in a manner that protects against allergen cross-contact and against contamination.
• (8) Raw materials and other ingredients that are food allergens, and rework that contains food allergens, must be identified and held in a manner that prevents allergen cross-contact.
• (c) Manufacturing operations.
• (1) Equipment and utensils and food containers must be maintained in an adequate condition through appropriate cleaning and sanitizing, as necessary. Insofar as necessary, equipment must be taken apart for thorough cleaning.
• (2) All food manufacturing, processing, packing, and holding must be conducted under such conditions and controls as are necessary to minimize the potential for the growth of microorganisms, allergen cross-contact, contamination of food, and deterioration of food.
• (3) Food that can support the rapid growth of undesirable microorganisms must be held at temperatures that will prevent the food from becoming adulterated during manufacturing, processing, packing, and holding.
• (4) Measures such as sterilizing, irradiating, pasteurizing, cooking, freezing, refrigerating, controlling pH, or controlling a_w that are taken to destroy or prevent the growth of undesirable microorganisms must be adequate under the conditions of manufacture, handling, and distribution to prevent food from being adulterated.
• (5) Work-in-process and rework must be handled in a manner that protects against allergen cross-contact, contamination, and growth of undesirable microorganisms.
• (6) Effective measures must be taken to protect finished food from allergen cross-contact and from contamination by raw materials, other ingredients, or refuse. When raw materials, other ingredients, or refuse are unprotected, they must not be handled simultaneously in a receiving, loading, or shipping area if that handling could result in allergen cross-contact or contaminated food. Food transported by conveyor must be protected against allergen cross-contact and against contamination as necessary.
• (7) Equipment, containers, and utensils used to convey, hold, or store raw materials and other ingredients, work-in-process, rework, or other food must be constructed, handled, and maintained during manufacturing, processing, packing, and holding in a manner that protects against allergen cross-contact and against contamination.
• (8) Adequate measures must be taken to protect against the inclusion of metal or other extraneous material in food.
• (9) Food, raw materials, and other ingredients that are adulterated:
• (i) Must be disposed of in a manner that protects against the contamination of other food; or
• (ii) If the adulterated food is capable of being reconditioned, it must be:
• (A) Reconditioned (if appropriate) using a method that has been proven to be effective; or
• (B) Reconditioned (if appropriate) and reexamined and subsequently found not to be adulterated within the meaning of the Federal Food, Drug, and Cosmetic Act before being incorporated into other food.
• (10) Steps such as washing, peeling, trimming, cutting, sorting and inspecting, mashing, dewatering, cooling, shredding, extruding, drying, whipping, defatting, and forming must be performed so as to protect food against allergen cross-contact and against contamination. Food must be protected from contaminants that may drip, drain, or be drawn into the food.
• (11) Heat blanching, when required in the preparation of food capable of supporting microbial growth, must be effected by heating the food to the required temperature, holding it at this temperature for the required time, and then either rapidly cooling the food or passing it to subsequent manufacturing without delay. Growth and contamination by thermophilic microorganisms in blanchers must be minimized by the use of adequate operating temperatures and by periodic cleaning and sanitizing as necessary.
• (12) Batters, breading, sauces, gravies, dressings, dipping solutions, and other similar preparations that are held and used repeatedly over time must be treated or maintained in such a manner that they are protected against allergen cross-contact and against contamination, and minimizing the potential for the growth of undesirable microorganisms.
• (13) Filling, assembling, packaging, and other operations must be performed in such a way that the food is protected against allergen cross-contact, contamination and growth of undesirable microorganisms.
• (14) Food, such as dry mixes, nuts, intermediate moisture food, and dehydrated food, that relies principally on the control of a_w for preventing the growth of undesirable microorganisms must be processed to and maintained at a safe moisture level.
• (15) Food, such as acid and acidified food, that relies principally on the control of pH for preventing the growth of undesirable microorganisms must be monitored and maintained at a pH of 4.6 or below.
• (16) When ice is used in contact with food, it must be made from water that is safe and of adequate sanitary quality in accordance with § 117.37(a), and must be used only if it has been manufactured in accordance with current good manufacturing practice as outlined in this part. 

Storage and transportation of food must be under conditions that will protect against allergen cross-contact and against biological, chemical (including radiological), and physical contamination of food, as well as against deterioration of the food and the container. 

• (a) The manufacturer, processor, packer, and holder of food must at all times utilize quality control operations that reduce natural or unavoidable defects to the lowest level currently feasible.
• (b) The mixing of a food containing defects at levels that render that food adulterated with another lot of food is not permitted and renders the final food adulterated, regardless of the defect level of the final food. For examples of defect action levels that may render food adulterated, see the Defect Levels Handbook, which is accessible at http://www.fda.gov/pchfrule and at http://www.fda.gov.

This information is for educational purposes only and is not to be considered legal advice. Prior to relying on this information, please contact one of our attorneys for a consultation.