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Oklahoma Administrative Code (Last Updated: March 11, 2021) |
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TITLE 310. Oklahoma State Department of Health |
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Chapter 681. Medical Marijuana Regulations |
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Subchapter 8. Laboratory Testing |
SECTION 310:681-8-1. Testing standards and thresholds
Latest version.
- (a) Purpose. To ensure the suitability and safety for human consumption of medical marijuana and medical marijuana products, growers and processors are required to test medical marijuana and medical marijuana products for microbials, mycotoxins, residual solvents, pesticides, THC and cannabinoid potency, terpenoid potency, heavy metals, foreign materials and filth, and water activity and moisture content in accordance with the following standards and thresholds. No laboratory may test medical marijuana without a valid, unexpired testing laboratory license issued by the Department. A licensed laboratory shall only send samples for testing to another licensed laboratory.(b) Batches. Growers shall separate all harvested medical marijuana into harvest batches not to exceed ten (10) pounds. Processors shall separate all medical marijuana product lots into production batches not to exceed ten (10) pounds.(c) Frequency. Growers and processors shall ensure samples from each harvest batch and production batch are tested in accordance with the Oklahoma Medical Marijuana and Patient Protection Act, 63 O.S. § 427.1 et seq., and these Rules. Growers shall not sell or otherwise transfer any medical marijuana from any medical marijuana harvest batch until samples of the harvest batch have passed all tests in accordance with this Subchapter. Processors shall not process, sell, or otherwise transfer any medical marijuana products from any medical marijuana production batch until samples of the production batch have passed all tests in accordance with this Subchapter.(d) Prohibitions.(1) Growers shall not sell or otherwise transfer any medical marijuana from any medical marijuana harvest batch until samples of the harvest batch have passed all tests in accordance with this Subchapter.(2) Processors shall not process, sell, or otherwise transfer any medical marijuana products from any medical marijuana production batch until samples of the production batch have passed all tests in accordance with this Subchapter.(3) Dispensaries shall not purchase, accept transfer of, or sell any medical marijuana or medical marijuana products that have not passed all tests in accordance with this Subchapter. Dispensaries shall obtain and maintain copies of the certificate of analysis (COAs) for all medical marijuana and medical marijuana products the dispensary purchases. Growers and processors shall provide dispensaries with copies of certificates of analysis upon request.(e) Department required testing. The Department may require a medical marijuana commercial business to submit a sample of medical marijuana, medical marijuana concentrate, or medical marijuana product to a licensed testing laboratory upon demand. The costs for all sampling and tests conducted pursuant to these rules shall be the financial responsibility of the business licensee.(f) Prohibited transfers. Growers and processors shall dispose of and shall not use, sell, or otherwise transfer any medical marijuana or medical marijuana products that exceed any testing thresholds or fail to meet any other standards set forth in this Subchapter.(g) Recall. In the event that any medical marijuana or medical marijuana products that exceed allowable testing thresholds or that otherwise fail to meet standards set forth in this Subchapter are sold or otherwise transferred, the following shall occur:(1) Any commercial licensee with knowledge of such event shall immediately notify the Department;(2) All such medical marijuana and medical marijuana products shall be immediately recalled; and(3) Every commercial licensee who is in possession or has ever had possession of such medical marijuana or medical marijuana products shall assist in the immediate recall.(h) Retention of test results and records. Processors and growers shall retain all test results and related records for at least two (2) years.(i) Allowable thresholds. If changes to this Subsection require a change in methodology, proficiency testing enrollment, or accreditation the medical marijuana testing laboratory has up to ninety (90) days to comply.(1) Microbiological testing. Harvest batch samples and production batch samples shall be tested for microbial limits as set forth in Appendix A.(2) Mycotoxins. Production batch samples shall be tested for mycotoxins as set forth in Appendix A.(3) Residual solvents and chemical residue. Production batch samples shall be tested for residual solvents and chemical residue as set forth in Appendix A. If the cannabis concentrate used to make an infused product was tested for solvents and chemical residue and test results indicate the lot was within established limits, then the infused product does not require additional testing for solvents and chemical residue.(4) Metals.(A) All harvest batch and production batch samples shall be tested for heavy metals, which shall include but is not limited to lead, arsenic, cadmium, and mercury.(B) Test results shall meet thresholds set forth in Appendix A.(C) If the cannabis concentrate used to make an infused product was tested for metals and test results indicate the lot was within established limits, then the infused product does not require additional testing for metals.(5) Pesticide residue. All harvest batch and production batch samples shall be tested for the following pesticides, and shall not exceed the associated limits:(A) Spiromesifen < 0.2 ppm(B) Spirotetramat < 0.2 ppm(C) Tebuconazole < 0.4 ppm(D) Etoxazole < 0.2 ppm(E) Imazalil < 0.2 ppm(F) Imidacloprid < 0.4 ppm(G) Malathion < 0.2 ppm(H) Myclobutanil < 0.2 ppm(I) Azoxystrobin < 0.2 ppm(J) Bifenazate < 0.2 ppm(K) Abamectin (Avermectins: B1a & B1b) < 0.5 ppm(L) Permethrin (mix of isomers) < 0.2 ppm(M) Spinosad (Mixture of A and D) < 0.2 ppm(6) Potency. Processors and growers shall test harvest batch and production batch samples for levels of total THC and terpenoid potency.(7) Foreign materials and filth. Growers and processors shall inspect all medical marijuana and medical marijuana products for contaminants and filth.(A) Contaminants include any biological or chemical agent, foreign matter, or other substances not intentionally added to medical marijuana or medical marijuana products that may compromise safety or suitability.(B) The surface area of each sample shall not contain more than two percent (2%) of foreign organic material.(C) Samples shall not contain any presence of inorganic material, including but not limited to plastic, glass, and metal shavings.(D) Inspection records shall indicate a continual process of physical inspection has taken place for all batches.(8) Water activity and moisture content.(A) All harvest batch samples shall be tested to determine the level of water activity and the percentage of moisture content. This subsection shall not apply to harvest batches that are flash frozen.(B) A harvest batch sample shall be deemed to have passed water activity testing if the water activity does not exceed 0.65 Aw. The laboratory shall report the result of the water activity test, to two significant figures, on the certificate of analysis (COA) and indicate "pass" or "fail" on the COA.(C) A harvest batch sample shall be deemed to have passed moisture content testing if the moisture content does not exceed fifteen percent (15.0%). The laboratory shall report the result of the moisture content test to the nearest tenth of one percent, by weight, of the dry sample on the COA and indicate "pass" or "fail" on the COA.(j) Remediation and retesting, general.(1) If a sample fails testing under this Subchapter, the harvest batch or production from which the sample was taken:(A) May be remediated or decontaminated in accordance with these Rules; or(B) If it is not or cannot be remediated or decontaminated under these Rules, it must be disposed in accordance with the Medical Marijuana Waste Management Act, 63 O.S. § 427a et seq. and these Rules.(2) A harvest batch or production batch that has failed testing and has been remediated or decontaminated must be re-tested and successfully pass all the analyses required under this Subchapter. If the harvest batch or product batch fails to pass testing after remediation or decontamination, the harvest batch or production batch must be disposed of in accordance with the Waste Management Act, 63 O.S. § 427a et seq. and these Rules.(3) Growers and processors may remediate failed harvest batches or production batches providing the remediation method does not impart any toxic or deleterious substance to the usable medical marijuana or medical marijuana products. Any remediation methods or remediation solvents used on medical marijuana or medical marijuana products must be disclosed to the testing laboratory.(4) Growers and processers must, as applicable:(A) Have detailed procedures for remediation and decontamination processes to remove microbiological contaminants and foreign materials, and for reducing the concentration of solvents.(B) Prior to retesting, provide to the testing laboratory a document specifying how the product was remediated or decontamination. This document shall be retained by the laboratory together with other testing documentation.(C) Document all re-sampling, re-testing, decontamination, remediation, and/or disposal of marijuana or marijuana-derived products that fail laboratory testing under these Rules.(5) At the request of the grower or processor, the Department may authorize a re-test to validate a failed test result on a case-by-case basis. All costs of the re-test will be borne by the grower or the processor requesting the re-test.(6) Growers and processors must inform a laboratory prior to samples being taken that the harvest batch or production batch has failed testing and is being re-tested after undergoing remediation or decontamination.(k) Remediation and retesting, microbiological impurities testing.(1) If a sample from a production batch fails microbiological contaminant testing, the batch may be used to make a cannabinoid concentrate or extract if the processing method effectively decontaminates the batch.(2) If a sample from a batch of a cannabinoid concentrate or extract fails microbiological contaminant testing, the batch may be further processed, if the processing method effectively decontaminates the batch, such as a method using a hydrocarbon-based solvent or a CO2 closed-loop system.(3) A batch that is decontaminated in accordance with subsection (1) or (2) of this section must be sampled and tested in accordance with these rules and must be tested, if not otherwise required for that product, for microbiological contaminants, residual solvents and processing chemicals and residual pesticides.(4) A batch that fails microbiological contaminant testing after undergoing a decontamination process in accordance with subsection (1) or (2) of this section must be disposed in accordance with the Oklahoma Medical Marijuana Waste Management Act, 63 O.S. § 427a et seq., and these Rules.(l) Remediation and retesting, residual solvent and processing chemicals testing.(1) If a sample from a batch fails residual solvent and processing chemicals testing, the batch may be remediated using procedures that would reduce the concentration of solvents to less than the action level.(2) A batch that is remediated in accordance with subsection (1) of this section must be sampled and retested for solvents in accordance with these Rules and must be tested, if not otherwise required for that product under these rules, for pesticides.(3) A batch that fails residual solvent and processing chemicals testing and is not remediated or is remediated and fails retesting must be disposed in accordance with the Oklahoma Medical Marijuana Waste Management Act, 63 O.S. § 427a et seq., and these Rules.(m) Remediation and retesting, foreign materials testing.(1) If a sample from a batch of usable marijuana fails foreign materials testing, the batch from which the sample was taken may be remediated to reduce the amount of foreign materials to below action levels.(2) A batch that undergoes remediation as described in subsection (1) of this section must be sampled and tested in accordance with these Rules.(n) Remediation and retesting, residual pesticide testing.(1) If a sample from a batch fails residual pesticide testing, the batch may not be remediated and must be disposed in accordance with the Oklahoma Medical Marijuana Waste Management Act, 63 O.S. § 427a et seq., and these Rules.(2) The Department may report to the Oklahoma Department of Agriculture all test results showing samples failing residual pesticide testing.(o) Remediation and retesting, heavy metals testing.(1) If a sample from a batch fails heavy metals testing, the batch may not be remediated and must be disposed in accordance with the Oklahoma Medical Marijuana Waste Management Act, 63 O.S. § 427a et seq., and these Rules.(2) The Department may report to the Oklahoma Department of Environmental Quality all test results showing samples failing heavy metals testing.(p) Remediation and retesting, mycotoxin testing.(1) If a sample from a batch fails mycotoxins testing, the batch may not be remediated and must be disposed in accordance with the Oklahoma Medical Marijuana Waste Management Act, 63 O.S. § 427a et seq., and these Rules.(q) Remediation and resting, water activity and moisture content.(1) If a harvest batch sample fails water activity and/or moisture content testing, the harvest batch may be further dried and cured by the grower.(2) A harvest batch that undergoes remediation as described in subsection (1) of this section must be sampled and tested in accordance with these Rules. If the harvest batch passed initial testing for residual solvents and chemical residue, metals, and/or pesticides, then the harvest batch does not require additional testing for those testing categories.