Tenn. Comp. R. & Regs. 0080-10-01-.05

Current through October 22, 2024

Section 0080-10-01-.05 - [Effective until 12/25/2024] SAMPLING AND TESTING

(1) Tolerances. HDC product manufacturers must cause each batch of HDC product they manufacture to be sampled and tested. Prior to transport of any HDC product in commerce, HDC product manufacturers must confirm conformance of the batch to all testing requirements under this rule.

(a) For raw hemp products in commerce post-harvest (e.g., flower), pre-harvest COAs for the products are presumptively valid for subsequent holders in commerce, provided that:

1. The hemp product was grown by a hemp producer licensed by the department;

2. The holder maintains a copy of the COA for the harvest that produced the product, showing pre-harvest compliance of the product's crop with all testing requirements under this rule; and,

3. The product has not been subjected to physical or chemical alteration post-harvest and has only been filtered, cleaned, or trimmed to isolate particular parts of the hemp plant.

4. This subparagraph shall not limit the department's authority to test raw cannabis products for compliance with the Act and this chapter.

(b) Tolerances for each required testing analyte are listed below. Any test result exceeding allowable limits is grounds for destruction of the entire batch represented by the sample, regardless of whether the test result is discovered through manufacturing testing or subsequent sampling and testing of retail HDC product.

1. For all HDC products:

(i) Hemp-derived cannabinoids:

(I) Delta-8 tetrahydrocannabinol [Reserved];

(II) Delta-10 tetrahydrocannabinol [Reserved];

(III) Hexahydrocannabinol [Reserved];

(IV) Tetrahydrocannabiphorol (THCp) [Reserved];

(V) Tetrahydrocannabivarin (THCv) [Reserved]; and,

(VI) Tetrahydrocannabinolic acid (THCa):

I. HDC products in commerce to an HDC product licensee (post-decarboxylation THC value <= 5%);

II. HDC products in commerce to any person who is not an HDC product licensee (post-decarboxylation THC value <= 0.3%);

(ii) Microbial contaminants:

(I) Shiga toxin-producing Escherichia coli (undetectable in at least one gram);

(II) Salmonella spp. (undetectable in at least one gram);

(iii) Mycotoxins:

(I) Aflatoxin B1 (total aflatoxin B1, B2, G1, and G2 <= 20 µg/kg);

(II) Aflatoxin B2 (total aflatoxin B1, B2, G1, and G2 <= 20 µg/kg);

(III) Aflatoxin G1 (total aflatoxin B1, B2, G1, and G2 <= 20 µg/kg);

(IV) Aflatoxin G2 (total aflatoxin B1, B2, G1, and G2 <= 20 µg/kg);

(V) Ochratoxin A (<= 20 µg/kg);

(iv) Residual pesticides:

Residual pesticide	Chemical Abstract Service (CAS) assigned number	Maximum allowable concentration stated in parts per million (ppm)
Abamectin	71751-41-2	0.5 ppm
Acephate	30560-19-1	0.4 ppm
Acequinocyl	57960-19-7	2.0 ppm
Acetamiprid	135410-20-7	0.2 ppm
Aldicarb	116-06-3	0.4 ppm
Azoxystrobin	131860-33-8	0.2 ppm
Bifenazate	149877-41-8	0.2 ppm
Bifenthrin	82657-04-3	0.2 ppm
Boscalid	188425-85-6	0.4 ppm
Carbaryl	63-25-2	0.2 ppm
Carbofuran	1563-66-2	0.2 ppm
Chlorantraniliprole	500008-45-7	0.2 ppm
Chlorfenapyr	122453-73-0	1.0 ppm
Chlormequat chloride	7003-89-6	0.2 ppm
Chlorpyrifos	2921-88-2	0.2 ppm
Clofentezine	74115-24-5	0.2 ppm
Cyfluthrin	68359-37-5	1.0 ppm
Cypermethrin	52315-07-8	1.0 ppm
Daminozide	1596-84-5	1.0 ppm
DDVP (Dichlorvos)	62-73-7	0.1 ppm
Diazinon	333-41-5	0.2 ppm
Dimethoate	60-51-5	0.2 ppm
Ethoprophos	13194-48-4	0.2 ppm
Etofenprox	80844-07-1	0.4 ppm
Etoxazole	153233-91-1	0.2 ppm
Fenoxycarb	72490-01-8	0.2 ppm
Fenpyroximate	134098-61-6	0.4 ppm
Fipronil	120068-37-3	0.4 ppm
Flonicamid	158062-67-0	1.0 ppm
Fludioxonil	131341-86-1	0.4 ppm
Hexythiazox	78587-05-0	1.0 ppm
Imazalil	35554-44-0	0.2 ppm
Imidacloprid	138261-41-3	0.4 ppm
Kresoxim-methy	143390-89-0	0.4 ppm
Malathion	121-75-5	0.2 ppm
Metalaxyl	57837-19-1	0.2 ppm
Methiocarb	2032-65-7	0.2 ppm
Methomyl	16752-77-5	0.4 ppm
Methyl parathion	298-00-0	0.2 ppm
Myclobutanil	88671-89-0	0.2 ppm (prohibited at any concentration for inhalation)
Naled	300-76-5	0.5 ppm
Oxamyl	23135-22-0	1.0 ppm
Paclobutrazol	76738-62-0	0.4 ppm
Permethrins (measured as the cumulative residue of cis- and trans-isomers)	52645-531 (54774-45-7 and 51877-74-8)	0.2 ppm
Phosmet	732-11-6	0.2 ppm
Piperonyl butoxide	51-03-6	2.0 ppm
Prallethrin	23031-36-9	0.2 ppm
Propiconazole	60207-90-1	0.4 ppm
Propoxur	114-26-1	0.2 ppm
Pyrethrins (measured as the cumulative residue of pyrethrin 1, cinerin 1 and jasmolin 1)	8003-34-7 (121-21-1,25402-06-6 and 4466-14-2)	1.0 ppm
Pyridaben	96489-71-3	0.2 ppm
Spinosad	168316-95-8	0.2 ppm
Spiromesifen	283594-90-1	0.2 ppm
Spirotetramat	203313-25-1	0.2 ppm
Spiroxamine	118134-30-8	0.4 ppm
Tebuconazole	107534-96-3	0.4 ppm
Thiacloprid	111988-49-9	0.2 ppm
Thiamethoxam	153719-23-4	0.2 ppm
Trifloxystrobin	141517-21-7	0.2 ppm

(v) Heavy metals:

(I) Arsenic (<= 0.4 ppm);

(II) Cadmium (<= 0.4 ppm);

(III) Lead (<= 1 ppm);

(IV) Mercury (<= 1.2 ppm);

(vi) Residual solvents and manufacturing chemicals:

Solvent or manufacturing chemical	CAS assigned number	Maximum allowable concentration (ppm)
Acetone	67-64-1	1,000 ppm
Benzene*	71-43-2	2 ppm
Butanes, (measured as the cumulative residue of n-butane and iso-butane),	106-97-8 and 75-28-5	1,000 ppm
Ethanol	64-17-5	1,000 ppm
Ethyl Acetate	141-78-6	1,000 ppm
Heptanes	142-82-5	1,000 ppm
Hexanes* (measured as the cumulative residue of n-hexane, 2-methylpentane, 3-methylpentane, 2,2-dimethylbutane, and 2,3-dimethylbutane)	110-54-3, 107-83-5 and 79-29-8	60 ppm
Methanol*	67-56-1	600 ppm
Pentanes (measured as the cumulative residue of n-pentane, iso-pentane, and neo-pentane)	109-66-0, 78-78-4 and 463-82-1	1,000 ppm
2-Propanol (IPA)	67-63-0	1,000 ppm
Propane	74-98-6	1,000 ppm
Toluene*	108-88-3	180 ppm
Total Xylenes* (measured as the cumulative residue of 1,2-dimethylbenzene, 1,3-dimethylbenzene, and 1,4-dimethylbenzene, and the non-xylene, ethylbenzene)	1330-20-7 (95-47-6, 108-38-3 and 106-42-3 and 100-41-4)	430 ppm
Any other solvent not permitted for use		undetected
*These solvents are not individually approved for use. Due to their possible presence in other solvents that are approved for use, limits have been listed here for concentrations in final products.

(c) Additional testing requirements for inhalable HDC products:

1. Microbial contaminants:

(i) Aspergillus A. fumigatus (undetectable in at least one gram);

(ii) Aspergillus A. flavus (undetectable in at least one gram);

(iii) Aspergillus A. niger (undetectable in at least one gram);

(iv) Aspergillus A. terreus (undetectable in at least one gram);

2. Heavy metals:

(i) Arsenic (<= 0.2 ppm);

(ii) Cadmium (<= 0.2 ppm);

(iii) Lead (<= 0.5 ppm);

(iv) Mercury (<= 0.1 ppm).

(2) Sampling. HDC product manufacturers must draw samples for testing that are representative of each batch.

(3) Testing.

(a) Third-party laboratories.

1. COAs required under this chapter may be supplied by a third-party laboratory provided the laboratory is registered with the department.

2. To register and to maintain registration with the department, a third-party laboratory applicant must:

(i) Complete in full an application for registration on forms provided by the department;

(ii) Host and notify the department of one landing page for retrieval of all COAs issued by the laboratory through use of quick reference (QR) codes;

(iii) For any test method conducted pursuant to this rule, be fully accredited to standards established under International Organization for Standardization (ISO) 17025 by an International Laboratory Accreditation Cooperation recognized accreditation body;

(iv) Maintain ISO 17025 accreditation;

(v) Test and report analyte(s) using limits of detection and quantitation no greater than the respective tolerance(s) under this chapter for the tested analyte(s);

(vi) Test and report hemp-derived cannabinoids under this chapter using a limit of quantitation <= 1 mg/g;

(vii) Perform and report component testing as detailed under this rule;

(viii) Store all samples in a secure manner that reasonably protects them from degradation, contamination, and tampering; and, prior to its disposal, render all sample material unusable;

(ix) If available, produce reserve sample material to the department upon request; and,

(x) Provide other information as required by the department.

3. Failure to adhere to these requirements or COA requirements under this rule is grounds for denial or revocation of any registration or authorization issued by the department.

(b) COAs.

1. Third-party laboratories must include at a minimum the following on each COA issued:

(i) The laboratory's name and address as it is registered with the department;

(ii) The HDC product manufacturer's name and address as it is registered with the department;

(iii) The batch number of HDC product represented by the sample;

(iv) Unique identifying information for the sample, if applicable;

(v) Sample history including date received and date range of each test conducted on the sample; and,

(vi) Analytical methods, limits of detection, limits of quantitation, and test results for each analyte evaluated for the sample, regardless of whether the testing conducted is required by this rule.

2. When reporting quantitative results, third-party laboratories must include in the COA the corresponding units of measurement as required for tolerances under this rule, as well as measurement uncertainties.

3. A result of "lt; LOQ" for any analyte detected below the limit of quantification (LOQ).

4. A result of "ND" for any analyte that was tested for and not detected (ND).

(c) Failed testing.

1. Retesting. Any sample failure may be re-submitted as follows for confirmation of testing failure.

(i) If a reserve sample was retained by the same third-party registered laboratory that produced the COA exhibiting a test failure, that laboratory may re-test the reserve sample following the failed test in order to confirm component compliance.

(ii) If the re-tested sample passes for the suspect component(s), a new sample from the same batch must be drawn and submitted to a second third-party registered laboratory for complete re-testing of all components listed under this rule. If the second re-testing conforms to all required tolerances, the batch is deemed compliant with testing requirements and may be transported and distributed in commerce.

(iii) If a reserve sample is not available from the initial third-party registered laboratory or if a sample fails either of the re-tests, the batch is deemed nonconforming with regulatory requirements.

2. Remedy.

(i) Microbial contaminants. An HDC product manufacturer is prohibited from transporting or allowing transport of a batch that has failed microbial contaminant testing unless:

(I) The batch is further processed by a method that effectively sterilizes the batch, is re-tested, and those test results show conformance with required tolerances; or,

(II) The batch is rendered unusable.

(ii) Over-concentrated product. An HDC product manufacturer is prohibited from transporting or allowing transport of a batch that has failed THC concentration testing unless:

(I) The batch is further processed by a method that effectively dilutes the batch, is retested, and those results show conformance with required tolerances;

(II) The batch is under immediate transport to a licensed HDC product manufacturer for purposes of diluting the batch and the batch and remediation plan are reported to the department prior to transport; or,

(III) The batch is rendered unusable.

(iii) For all other component testing failures, an HDC product manufacturer must render the batch unusable.

Tenn. Comp. R. & Regs. 0080-10-01-.05

Emergency rules filed 6/28/2024; exp. through 12/25/2024 (Emergency).

Authority: T.C.A. §§ 4-3-203 and 43-27-211.