Testing standards and thresholds

(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 type and concentration, 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. (1) Batch size. Growers shall separate all harvested medical marijuana into harvest batches not to exceed ten (10) fifteen (15) pounds with the exception of any plant material to be sold to a licensed processor for the purposes of turning the plant material into concentrate which may be separated into harvest batches of no more than fifty (50) pounds. Processors shall separate all medical marijuana product lots into production batches not to exceed ten (10) pounds four (4) liters of liquid medical marijuana concentrate or nine (9) pounds for nonliquid medical marijuana products, and for final medical marijuana products no greater than one-thousand (1,000) grams of THC. (c) Frequency. Growers and processors shall ensure samples from each harvest batch and production batch are collected, labeled, and tested in accordance with the Oklahoma Medical Marijuana and Patient Protection Act, 63 O.S. § 427.1 et seq., and these Rules. (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, except that growers may sell or otherwise transfer harvest batches that have failed microbiological testing to processors for decontamination or remediation in accordance with OAC 310:681-8-1(l)(2). Remediated and decontaminated medical marijuana only may be returned to the originating license commercial grower. (2) Processors shall not purchase or otherwise obtain, process, sell, or otherwise transfer any medical marijuana or medical marijuana products from any medical marijuana harvest batch or production batch until samples of the harvest batch or production batch have passed all tests in accordance with this Subchapter, except that processors may purchase or otherwise obtain and process harvest batches that have failed testing for the purpose of remediation only in accordance with OAC 310:681-8-1(l)(2). (3) Dispensaries shall not purchase, accept transfer of, or sell, or otherwise transfer any medical marijuana or medical marijuana products that have not passed all tests in accordance with this Subchapter. (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 2021.11.23_OSDH681_OMMARulesChapterAsAmended 82 licensed testing laboratory or upon demand. The costs for all sampling and tests conducted pursuant to these rules shall be the financial responsibility of the business licensee the quality assurance laboratory upon demand when the Department has reason to believe the medical marijuana is unsafe for patient consumption or inhalation or has not been tested in accordance with Oklahoma law and these regulations. The Department may also require a medical marijuana business to periodically submit samples of medical marijuana or medical marijuana products to the quality assurance laboratory no more than twice a year for quality assurance purposes. The licensee shall provide the samples or units of medical marijuana or medical marijuana products at its own expense but shall not be responsible for the costs of testing. (f) Prohibited transfers. Except as is authorized in these Rules, growers, processors, and dispensaries 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 or requirements set forth in this Subchapter. (g) Embargo and Recall. (1) Embargo. In the event that any medical marijuana or medical marijuana products product is found by either a testing laboratory or the quality assurance laboratory that to exceed the allowable testing thresholds or that otherwise fail to meet standards set forth in this Subchapter are sold or otherwise transferred, the following shall occur under These Rules; or which otherwise contains analytes which may be poisonous, deleterious to health or otherwise unsuitable or unsafe for human consumption; or where such medical marijuana or medical marijuana product is in violation of applicable laws, rules or regulations, the following shall occur by commercial licensees: (1)(A) Any commercial licensee with knowledge of such event shall immediately notify the Department;. (2)(B) All such medical marijuana and medical marijuana products in the possession of a commercial licensee shall be immediately recalled; and affixed with an electronic tag, physical tag and/or other appropriate marking or hold, including a hold in the State's inventory tracking system, giving notice of the reason that the medical marijuana or medical marijuana product is subject to embargo. The affixed tag(s) and/or electronic hold shall further warn all persons not to remove or dispose of the medical marijuana or medical marijuana product by sale, donation, or otherwise transfer without permission of the Authority. It shall be unlawful for any person to remove or dispose of the embargoed medical marijuana or medical marijuana products without permission of the Authority. (C) The Authority, upon determination that any medical marijuana or medical marijuana product tests result exceed allowable thresholds, is in violation of applicable laws, rules or regulations, or is otherwise poisonous, deleterious to health or unsafe for consumption may institute an action in a district court of competent jurisdiction for the condemnation and destruction of the medical marijuana or medical marijuana product in accordance with 63 O.S. § 427.24. 2021.11.23_OSDH681_OMMARulesChapterAsAmended 83 (D) The Authority, upon determination that any medical marijuana or medical marijuana product meets the requirements of applicable laws, rules or regulations, or otherwise is not poisonous, deleterious to health or unsafe shall remove the embargo. (E) In the event any medical marijuana or medical marijuana products subject to an embargo is sold or otherwise transferred, such embargoed medical marijuana or medical marijuana products shall be recalled in accordance with these Rules. (3)(F) Every commercial licensee who is in possession or has ever had possession of such embargoed medical marijuana or medical marijuana products shall assist in the immediate recall embargo. (2) Recall. In the event that any medical marijuana or medical marijuana products that exceed allowable testing thresholds, are the subject of an embargo, or a derivative thereof, or that otherwise fail to meet standards set forth in this Subchapter are sold or otherwise transferred, the following shall occur: (A) Any commercial licensee with knowledge of such event shall immediately notify the Department; (B) All such medical marijuana and medical marijuana products shall be immediately recalled and cannot be sold or otherwise transferred; and (C) 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, including, but not limited to, the following.: (i) Undertake necessary measures to ensure any affected medical marijuana or medical marijuana products are not transferred; (ii) Create a distribution list of all commercial licensees that received the medical marijuana or medical marijuana products subject to the recall, including the licensee's name, license number, address and contact information; (iii) Create a list identifying all medical marijuana or medical marijuana products subject to the recall, including the category of medical marijuana or medical marijuana products, product description, net contents, batch number, and, if applicable, the name and license number of the commercial licensee that cultivated or manufactured the medical marijuana or medical marijuana product subject to the recall; (iv) Provide notice to all affected licensees and consumers once identified; (v) Communicate with the Department regarding the status of the recall and immediately provide all required information and documentation to the Department within forty-eight (48) hours unless granted additional time by the Department. (vi) The Licensee's failure to timely comply with the provisions of this subsection and/or provide required information and documentation to the Department may result in revocation, suspension, and monetary penalties. The Department may also issue a public recall notice, at any time, if it determines it is necessary to protect the 2021.11.23_OSDH681_OMMARulesChapterAsAmended 84 public's health safety and welfare. (D) The commercial licensee whose harvest or production batch is being recalled, and who bears responsibility for the recall, shall bear the costs for disposal of all medical marijuana waste subject to the recall in accordance with Oklahoma law and these Rules. (h) Retention of test results and records. (1) Prior to accepting any sale or transfer of any medical marijuana, growers shall obtain copies of any and all certificates of analysis (COAs) for every test conducted on the harvest batch(es) of the medical marijuana. (2) Prior to accepting any sale or transfer of any medical marijuana or medical marijuana products, processors shall obtain copies of any and all COAs for every test conducted on the harvest batch(es) of the medical marijuana or production batch(es) of the medical marijuana products. (3) Prior to accepting any sale or transfer of medical marijuana, dispensaries shall obtain copies of any and all COAs for every test conducted on the harvest batch(es); (4) Prior to accepting any sale or transfer of medical marijuana products, dispensaries shall obtain copies of any and all COAs for every test conducted on the production batch(es); (5) Commercial licensees shall maintain copies of any and all COAs for at least two (2) seven (7) years and these records must be kept onsite and readily accessible. (6) Growers and processors shall immediately provide copies of COAs to the Department upon request and to any medical marijuana licensee upon request when the purpose of such request is compliance with this Section. (7) Growers and processors shall, in the manner and form prescribed by the Department, provide notification to the Department of any medical marijuana or medical marijuana products that have failed testing. Such notification shall include copies of the applicable COAs. (8) For the purposes of this subsection, submission of a COA into the State's inventory tracking system is sufficient to meet a commercial licensee's requirements to report and maintain such records. (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 2021.11.23_OSDH681_OMMARulesChapterAsAmended 85 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 type and concentration. (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 2021.11.23_OSDH681_OMMARulesChapterAsAmended 86 (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) Retesting. If a harvest or production batch fails any analyte testing, the harvest or production batch may be retested in accordance with the following: (1) The reserve sample shall be used first for all retesting. If there is not enough reserve sample for any additional tests required under this Subsection, a new sample may be collected. The new sample must be a representative sample of the batch and shall be gathered in accordance with these Rules. (2) The retest may be limited to testing for the category of analyte that has failed testing. For example, if a primary sample fails pesticide testing, testing of the reserve sample may be limited to pesticide testing. (3) If the first retest fails testing for the same analyte that failed the initial test, the harvest or production batch must either be remediated or decontaminated in accordance with the Oklahoma Medical Marijuana and Patient Protection Act, 63 O.S. § 427.1 et seq., and these Rules, or must be disposed of in accordance with the Oklahoma Medical Marijuana Waste Management Act, 63 O.S. § 427a et seq. and these Rules. (4) If the first retest(s) passes testing, a second retest shall be conducted to confirm the product does not exceed allowable thresholds and is safe to consume. If the second retest also passes for the same analyte, the batch may be processed, sold, or otherwise transferred. If the second retest fails for the same analyte that failed the initial test, the harvest or production batch must either be remediated or decontaminated in accordance with the Oklahoma Medical Marijuana and Patient Protection Act, 63 O.S. § 427.1 et seq., and these Rules, or must be disposed of in accordance with the Oklahoma Medical Marijuana Waste Management Act, 63 O.S. § 427a et seq. and these Rules. (5) If during the first retest, a harvest batch or production batch fails testing for an analyte that passed initial testing, the harvest batch or production batch must pass testing for that analyte during the second retest. (6) Any harvest batch or production batch that is retested and does not have two (2) successful tests for each analyte must either be remediated or decontaminated in accordance with the Oklahoma Medical Marijuana and Patient Protection Act, 63 O.S. § 427.1 et seq., and these Rules, or must be disposed of in accordance with the Oklahoma Medical Marijuana Waste Management Act, 63 O.S. § 427a et seq. and these Rules. (k) Remediation, decontamination, and retesting, general. (1) If a sample fails testing under this Subchapter, the harvest batch or production batch from which the sample was taken: (A) May be remediated or decontaminated in accordance with these 2021.11.23_OSDH681_OMMARulesChapterAsAmended 87 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 been remediated or decontaminated must be fully tested and successfully pass all the analyses required under this Subchapter. If the harvest batch or production batch fails to pass testing after remediation or decontamination, the harvest batch or production batch must be either disposed of in accordance with the Waste Management Act, 63 O.S. § 427a et seq. and these Rules or retested in accordance with OAC 310:681-8-1(j) with the following exceptions: (A) Any harvest batch that has been decontaminated and fails retesting for microbials must be either remediated or disposed of in accordance with these Rules. (B) Any production batch that has been decontaminated and fails retesting shall not be further decontaminated. (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. (l) Remediation, decontamination, and retesting, microbiological impurities testing. (1) If a sample from a harvest batch or 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) A grower may only sell or otherwise transfer a harvest batch that has failed microbiological contaminant testing to a processor and only for the purpose of remediation. The processor shall either 2021.11.23_OSDH681_OMMARulesChapterAsAmended 88 remediate the harvest batch by processing it into a solvent-based concentrate or shall dispose of the batch in accordance with these Rules. Any production batches resulting from the remediation must be tested in accordance with OAC 310:681-8-1(k). Processors shall not sell any medical marijuana from any harvest batch that has failed testing. Harvest batches that have failed microbial testing may be sent to a processor for decontamination of microbial contaminants and returned to the grower. (3) 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. (4) A batch that is remediated or decontaminated in accordance with this Subsection 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. (5) 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. (m) Decontamination 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 decontaminated using procedures that would reduce the concentration of solvents to less than the action level. (2) A batch that is decontaminated in accordance with subsection (1) 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 decontaminated or is decontaminated 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. (n) Decontamination 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 decontamination as described in subsection (1) must be sampled and tested in accordance with these Rules. (o) Remediation, decontamination and retesting, residual pesticide testing. (1) If a sample from a batch fails residual pesticide testing, the batch may not be remediated or decontaminated and must be disposed in accordance with the Oklahoma Medical Marijuana Waste Management Act, 63 O.S. § 427a et seq., and these Rules. 2021.11.23_OSDH681_OMMARulesChapterAsAmended 89 (2) The Department may report to the Oklahoma Department of Agriculture all test results showing samples failing residual pesticide testing. (p) Remediation, decontamination and retesting, heavy metals testing. (1) If a sample from a batch fails heavy metals testing, the batch may not be remediated or decontaminated 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. (q) Remediation, decontamination and retesting, mycotoxin testing. (1) If a sample from a batch fails mycotoxins testing, the batch may not be remediated or decontaminated and must be disposed in accordance with the Oklahoma Medical Marijuana Waste Management Act, 63 O.S. § 427a et seq., and these Rules. (r) Decontamination and resting retesting, 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 decontamination as described in subsection (1) 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. (s) Testing of noninfused pre-rolls and kief. (1) Pre-rolls. Growers, processors, and dispensaries may create noninfused pre-rolls in accordance with Oklahoma law and these Rules. (A) Growers, processors, and dispensaries may create noninfused pre-rolls from flower, shake, or trim collected from multiple harvest batches. The plant material must be homogenized into a new batch not to exceed fifteen (15) pounds. Noninfused pre-rolls created by a grower, processor or dispensary are subject to the same testing requirements of a harvest batch under OAC 310:681-8- 1(i). (B) Growers, processors and dispensaries may create noninfused pre-rolls from flower, shake, or trim collected from a single harvest batch. If the noninfused flower, shake or trim come from a single harvest that has passed full compliance testing, growers, processors, and dispensaries must conduct additional on the pre-rolls only for heavy metals, filth and contaminants, and potency. (2) Kief. Growers and processors may collect kief from multiple harvest batches. The kief must be homogenized into a new batch not exceed fifteen (15) pounds. Kief collected by a grower is subject to the same testing requirements of a harvest batch under OAC 310:681- 8-1(i).