Rule 351-7-.08 - Certificate of Analysis(1) An independent laboratory shall only test and certify homogenized, controlled samples of product in final packaged form collected as set forth in Rule 351-7-.05.(2) An independent laboratory shall issue to the production licensee a certificate of analysis for each batch of product in final packaged form tested for that production licensee.(3) The certificate of analysis shall, at a minimum, include the results with supporting data for the following: (a) The chemical profile of the following cannabinoid compounds:1. Total tetrahydrocannabinol ("THC") sum percentage by weight of: (i) Delta-9-tetrahydrocannabinol (D9-THC);(ii) Delta-9-tetrahydrocannabinolic acid (THCA); and(iii) Delta-9-tetrahydrocannabivarin (THCV).2. Cannabichromene (CBC);3. Cannabichromene acetate (CBCA);5. Cannabidiolic acid (CBDA);7. Cannabigerol acetate (CBGA);9. Cannabidivarin (CBDV).(b) If an abnormality is found during the required testing listed above in subparagraph (a) of this rule, then the certificate of analysis shall also show test results for the presence of the following isomers and esters: 1. THC isomers, which have published peer-reviewed proficiency standards and measurements that have been validated for cannabis testing by an independent third party: (i) Delta-6a(7)-tetrahydrocannabinol (D6a(7)-THC);(ii) Delta-6a(10a)-tetrahydrocannabinol (D6a(10a)-THC);(iii) Delta-7-tetrahydrocannabinol (D7-THC);(iv) Delta-8-tetrahydrocannabinol (D8-THC);(v) Delta-9(11) exo-tetrahydrocannabinol (Exo-THC); and(vi) Delta-10-tetrahydrocannabinol (D10-THC).2. THC esters, which have published peer-reviewed proficiency standards and measurements that have been validated for cannabis testing by an independent third party: (i) THC-O acetate (THCOA);(iii) THC hemisuccinate (THC-HS); and(iv) THC morpholinyl butyrate (SP-111).(d) Residual solvents, which shall not exceed the following action levels, measured in parts per billion (ppb), for the following analytes: 9. Total Xylenes: 1,000 (i) Meta-xylene (m-xylene);(ii) Para-xylene (p-xylene); and(iii) Ortho-xylene (o-xylene).(e) The presence of the following heavy metals, which shall not exceed the following action levels, measured in parts per billion (ppb), for the following analytes by product: 1. Arsenic (i) Low-THC oil and products for nasal use such as nasal sprays: 200;(ii) Low-THC oil and products for sublingual use such as oils and tinctures: 500;(iii) Low-THC oil and products for ingestion such as capsule, lozenges, or other dissolvable solid dosage forms: 500; and(iv) Low-THC oil and products for topical use such as lotions, topicals, and transdermal patches: 500.2. Cadmium (i) Low-THC oil and products for nasal use such as nasal sprays: 200;(ii) Low-THC oil and products for sublingual use such as oils and tinctures: 500;(iii) Low-THC oil and products for ingestion such as capsule, lozenges, or other dissolvable solid dosage forms: 500; and(iv) Low-THC oil and products for topical use such as lotions, topicals, and transdermal patches: 500.3. Chromium (i) Low-THC oil and products for nasal use such as nasal sprays: 500,000;(ii) Low-THC oil and products for sublingual use such as oils and tinctures: 500,000;(iii) Low-THC oil and products for ingestion such as capsule, lozenges, or other dissolvable solid dosage forms: 1,100,000; and(iv) Low-THC oil and products for topical use such as lotions, topicals, and transdermal patches: 500,000.4. Lead (i) Low-THC oil and products for nasal use such as nasal sprays: 500;(ii) Low-THC oil and products for sublingual use such as oils and tinctures: 500;(iii) Low-THC oil and products for ingestion such as capsule, lozenges, or other dissolvable solid dosage forms: 500; and(iv) Low-THC oil and products for topical use such as lotions, topicals, and transdermal patches: 500.5. Mercury (i) Low-THC oil and products for nasal use such as nasal sprays: 200;(ii) Low-THC oil and products for sublingual use such as oils and tinctures: 500;(iii) Low-THC oil and products for ingestion such as capsule, lozenges, or other dissolvable solid dosage forms: 500; and(iv) Low-THC oil and products for topical use such as lotions, topicals, and transdermal patches: 500.(f) Pesticides regulated by the United States Environmental Protection Agency, including, but not limited to, the following, which shall not exceed an action level of 100 parts per billion (ppb) or the independent laboratory's lowest possible limit of quantitation (LOQ) for such respective analyte, whichever is lower: 14. Chlormequat Chloride;(g) Any visible foreign material that is not intended to be part of the product being produced, including, but not limited to, filth, hair, insects, metal, or plastic.(h) Microbial impurities, which shall not exceed the following action levels, measured in colony-forming unit per gram (cfu/g), for each of the following analytes: 1. Total viable aerobic bacteria: 100,000;2. Total yeast and mold: 10,000;3. Total coliforms: 1,000;4. Bile-tolerant gram negative bacteria: 1,000;5. Shiga-toxin producing escherichia coli (STEC) and salmonella spp.: 1.0; and6. Aspergillus fumigatus, Aspergillus flavus, Aspergillus niger, and Aspergillus terreus: 1.0.(i) Mycotoxins, which shall not exceed an action level of 20 parts per billion (ppb) for each of the following analytes: (4) The independent laboratory shall submit the certificate of analysis to the Commission and its employees at the same time the certificate of analysis is submitted to the originating production licensee.(5) The independent laboratory shall upload the certificate of analysis into a Commission-approved tracking system within twenty-four (24) hours of the completion of tests.(6) In addition to the requirements of this rule, the Commission may make available, via its website or other public means, additional bulletins outlining any contaminants and their actionable levels.Ga. Comp. R. & Regs. R. 351-7-.08
O.C.G.A. §§ 16-12-203, 16-12-210, 16-12-217.
Original Rule entitled "Certificate of Analysis" adopted. F. Mar. 16, 2023; eff. Apr. 5, 2023.Amended: F. Nov. 9, 2023; eff. Nov. 29, 2023.