Okla. Admin. Code § 442:10-8-6.1

Current through Vol. 41, No. 24, September 3, 2024

Section 442:10-8-6.1 - [Effective until 9/14/2024] Laboratory standardization recommendations for testing standards and thresholds

(a)Laboratory standardization recommendations. Beginning June 1, 2024, medical marijuana testing laboratories renewing their medical marijuana business license shall be subject to and comply with the following rules relating to the testing of medical marijuana, medical marijuana concentrate, and medical marijuana products. The refusal or failure of a medical marijuana testing laboratory licensee to comply with these rules relating to laboratory standards and testing procedures shall result in the permanent revocation of the medical marijuana testing laboratory license.

(b)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 concentration, terpenoid 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 Authority. A licensed laboratory shall only send samples for testing to another Oklahoma licensed laboratory.

(c)Batches.

(1)Batch size. Growers shall separate all harvested medical marijuana into harvest batches that weigh less than or equal to 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 that weigh less than or equal to fifty (= 50) pounds. Processors shall separate all medical marijuana product into production batches that contain a volume that is less than or equal to four (= 4) liters of liquid medical marijuana concentrate or that weigh less than or equal to nine (= 9) pounds for nonliquid medical marijuana products, and for final medical marijuana products shall contain less than or equal to one-thousand (= 1,000) grams of total delta-9-tetrahydrocannabinol ([DELTA]-9-THC).

(2)Research and Development (R&D) testing. Growers and processors may submit samples for research and development testing. R&D testing may be performed by a licensed laboratory in accordance with these Rules:

(A) Passing R&D test results. If a sample submitted to a laboratory passes a R&D test, it shall not constitute a pass for the purposes of compliance with required testing under OAC 442:10-8-1(i);

(B) Failing R&D test results. If a sample submitted to a laboratory fails a R&D test, laboratories shall clearly note in the State's inventory tracking system and on any COA created for an R&D sample that the test results are for R&D purposes only; and

(C) Growers and processors shall ensure that any R&D testing done under this subsection is appropriately documented and identified in the State's inventory tracking system.

(d)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.

(e)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 testing to processors for decontamination or remediation in accordance with OAC 442:10-8-1(l)(2). Growers may transfer medical marijuana from harvest batches to processors for decontamination prior to testing, so long as decontaminated medical marijuana is not processed into a solvent-based concentrate and is returned to the originating licensed commercial grower. Decontaminated harvest batches must successfully pass all tests in accordance with this Subchapter prior to transfer or sale.

(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 442:10-8-1(l)(2).

(3) Dispensaries shall not purchase, accept transfer of, sell, or otherwise transfer any medical marijuana or medical marijuana products that have not passed all tests in accordance with this Subchapter.

(f)Authority required testing. The Authority 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 or the quality assurance laboratory upon demand when the Authority 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 Authority may also require a medical marijuana business to periodically submit samples of medical marijuana or medical marijuana products to the quality assurance laboratory 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.

(g)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.

(h)Embargo and recall.

(1)Embargo. In the event that any medical marijuana or medical marijuana product is found by an authorized agent of the Authority to fail to meet the requirements of 63 O.S. § 420 et al., or the Oklahoma Medical Marijuana and Patient Protection Act as it relates to health and safety, the medical marijuana or medical marijuana product is handled in violation of applicable laws or rules and regulations promulgated by the Executive Director of the Authority, or the medical marijuana or medical marijuana product may be poisonous, deleterious to health or is otherwise unsafe, the following shall occur:

(A) All such medical marijuana and medical marijuana products in the possession of a commercial licensee shall be immediately 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.

(B) The Authority, upon determination that any medical marijuana or medical marijuana product embargoed 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.

(C) 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.

(D) In the event any medical marijuana or medical marijuana products subject to an embargo are sold or otherwise transferred, such embargoed medical marijuana or medical marijuana products shall be recalled in accordance with these Rules.

(E) 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 embargo.

(2)Recall. If any medical marijuana or medical marijuana products test above allowable thresholds, are the subject of an embargo, are otherwise determined to be unsafe, or that otherwise fail to meet standards set forth in this Subchapter, the following shall occur:

(A) Any commercial licensee with knowledge of such event shall immediately notify the Authority;

(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 Authority regarding the status of the recall and provide all required information and documentation to the Authority within two (2) weeks unless granted additional time by the Authority.

(vi) The Licensee's failure to timely comply with the provisions of this subsection and/or provide required information and documentation to the Authority may result in revocation, suspension, and monetary penalties. The Authority may also issue a public recall notice, at any time, if it determines it is necessary to protect the 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.

(i)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 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 Authority 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 Authority, provide notification to the Authority 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 by the laboratory into the State's inventory tracking system is sufficient to meet a commercial licensee's requirements to report and maintain such records.

(j)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. The in-sample limit of quantification (LOQ) must be less than or equal to fifty percent (= 50%) of the allowable thresholds listed in this Section.

(1)Microbial testing. Harvest batch samples and production batch samples shall be tested for microbial analytes in accordance with the following:

(A)Allowable thresholds. Samples shall be tested for the following microbial analytes and must be less than (<) the allowable thresholds, in colony forming units found in one gram (CFU/ g), listed below:

(i) All medical marijuana, medical marijuana products and medical marijuana concentrates, excluding pressurized metered dose inhaler products, metered dose nasal spray products, vaginal administration products or rectal administration products, shall be tested for the following microbial analytes and shall be less than the associated allowable threshold:

(I) Total yeast and mold microbials < 10⁴ CFU/g;

(II) Shiga toxin-producing Escherichia coli (STEC) < 1 CFU/g;

(III) Pathogenic Salmonella spp. < 1 CFU/g;

(IV) Aspergillus flavus < 1 CFU/g;

(V) Aspergillus fumigatus < 1 CFU/g;

(VI) Aspergillus niger < 1 CFU/g; and

(VII) Aspergillus terreus < 1 CFU/g.

(ii) Pressurized metered dose inhaler and metered dose nasal spray medical marijuana and medical marijuana products shall be tested for the following microbial analytes and shall be less than the associated allowable threshold:

(I) Total yeast and mold microbials < 10¹ CFU/g;

(II) Total aerobic microbials < 10² CFU/g;

(III) Staphylococcus aureus < 1 CFU/g; and

(IV) Bile tolerant gram-negative bacteria < 1 CFU/g.

(iii) Vaginal administration products shall be tested for the following microbial analytes and shall be less than the associated allowable threshold:

(I) Total yeast and mold microbials < 10¹ CFU/g;

(II) Total aerobic microbials < 10² CFU/g;

(III) Staphylococcus aureus < 1 CFU/g;

(IV) Pseudomonas aeruginosa < 1 CFU/g; and

(V) Candida albicans < 1 CFU/g.

(iv) Rectal administration products shall be tested for the following microbial analytes and shall be less than the associated allowable threshold;

(I) Total yeast and mold microbials < 10² CFU/g; and

(II) Total aerobic microbials < 10³ CFU/g.

(B)Instrumentation. Testing laboratories shall use a genetically based assay or agar plate culture to perform microbial testing. The manufacturer's instructions for use, including recommendations, must be followed, unless otherwise specified by these rules.

(C)Methodologies. The method employed by a testing laboratory must pass a matrix proficiency test as required by the Authority. The Authority will conduct the matrix proficiency test and will supply medical marijuana samples with known microbial contamination values. Passing values must demonstrate the expected result.

(D)Genetically based assay. Genetically based assay testing requirements are as follows:

(i)Sample preparation. Sample must weigh greater than or equal to one gram (= 1 g). Methods of microbial sample preparation that reduce or kill the targeted microbes, such as cryogenic grinding or heat introduction, shall not be used. If the manufacturer does not offer instructions or recommendations regarding enrichment and incubation, then the primary sample must be enriched and incubated for at least twenty-four (24) hours using enrichment media suitable for identification of the target organism

(ii)Laboratory quality control (LQC) samples. The following LQC samples must be run every twenty (20) samples in an analytic run and must include:

(I) A positive control, for each targeted organism, that shall result in detection of amplification. If amplification of the target organism is not detected, all samples in the associated batch shall be reanalyzed. A positive control shall be a positive template control that contains the DNA sequence of the targeted analyte or a positive extraction control that contains a sample of the live microbial analyte, that was extracted using the same process as the samples; and

(II) A negative control that shall not result in amplification. If amplification is detected, all samples in the associated batch shall be re-analyzed;

(III) A laboratory replicate sample that demonstrates repeatability of the initial sample; and

(IV) An internal control, in each sample, that contains a non-targeted DNA sequence that is co-amplified with the targeted sequences and results in detection of amplification. If amplification is not detected that sample shall be reprepared and reanalyzed in a different batch. If amplification is not detected a second time, the sample shall be re-extracted and reprepared for new analysis.

(iii)Reporting results. Microbial analytes shall be reported to the nearest whole number, in CFU. All results shall include the sample weight in grams (g).

(E)Agar plate culture. If using agar plate culture methodologies, the following requirements apply:

(i)Sample preparation. The primary sample must weigh greater than or equal to one gram (= 1 g). Methods of microbial sample preparation that may reduce or kill targeted microbes, such as cryogenic grinding or heat introduction, shall not be used. For non-quantitative testing, the primary sample must be enriched and incubated for at least twenty-four (24) hours using enrichment media suitable for identification of the target organism. The primary sample must be used for all additional analysis. If the primary sample has been depleted prior to additional analysis, the reserve sample must be enriched and incubated for forty-eight (48) hours, using enrichment media suitable for identification of the target organism.

(ii)Laboratory quality control (LQC) samples for qualitative agar plating. Plating techniques shall undergo an initial validation to determine an appropriate dilution factor. The following LQC samples must be run every twenty (20) samples and must include:

(I) A positive control, for each targeted microorganism, that shall result in detectable growth, or a positive reaction if the method uses a reaction to identify an organism;

(II) A negative control that shall not detect the presence of a microbial organism;

(III) An environmental negative control, a duplicate of the negative control, except that the plate shall remain open to the environment during the sample preparation period; and

(IV) A laboratory replicate sample with results that match the initial sample results, detecting the presence or absence of a microbial organism.

(iii)Laboratory quality control (LQC) samples for quantitative agar plating. Plating techniques shall undergo an initial validation to determine an appropriate dilution factor. The following LQC samples must be run every twenty (20) samples and must include:

(I) A positive control, for each targeted microorganism, that shall result in detectable growth;

(II) A negative control that shall not result in detectable microbial growth; and

(III) An environmental negative control, a duplicate of the negative control, except that the plate shall remain open to the environment during the sample preparation period.

(iv)Reporting results. Microbial analytes shall be reported to the nearest whole number, in CFU. All results shall include the sample weight in grams (g). A result that exceeds the allowable thresholds for a microbial analyte must be verified in duplicate using the original enrichment from the primary sample. If the primary sample has been depleted prior to additional analysis, the reserve sample must be enriched and incubated for forty-eight (48) hours, using enrichment media suitable for identification of the target organism. Upon re-analysis, any result that exceeds allowable thresholds shall be considered a failure the entire batch.

(2)Mycotoxins. Production batch samples shall be tested for mycotoxin analytes in accordance with the following:

(A)Allowable thresholds. Samples shall be tested for the following mycotoxin analytes and shall be less than (<) the allowable threshold, in parts per billion (ppb), listed below:

(i) [Aflatoxin B1 + Aflatoxin B2 + Aflatoxin G1 + Aflatoxin G2] < 20 ppb; and

(ii) Ochratoxin A < 20 ppb.

(B)Instrumentation. For mycotoxin analyte testing, laboratories shall use Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS) with Electrospray Ionization (ESI), LC-MS/MS with Atmospheric Pressure Chemical Ionization (APCI), or Enzyme Linked Immunosorbent Assay (ELISA).

(D)Sample preparation. Sample must weigh greater than or equal to five tenths of a gram (= 0.5 g). Sample preparation solvents must be Liquid Chromatography Mass Spectrometry (LC-MS) grade. Solid form samples shall be homogenized by blending, using a food processor or similar apparatus, or cryogrinding. Liquid form samples shall be homogenized by stirring. Analytes shall be extracted from the sample using the following techniques: solid-liquid extraction or solid phase extraction.

(E)Laboratory quality control (LQC) requirements.

(i)LQC samples. The following LQC samples must be run with each analytic run, and repeated every twenty (20) samples in an analytic run and must include:

(I) A method blank with a resulting value that is less than or equal to the limit of quantification (=LOQ);

(II) A laboratory control sample (LCS) with an acceptable limit that shall be plus or minus twenty percent (± 20%) of the known analyte concentration, in accordance with the following requirements. The LCS shall be spiked at or near the allowable thresholds for all required analytes to be reported and shall be determined with the correction factor applied. The LCS shall be carried through preparation and analysis as if it were a sample. A percent recovery calculation will be performed using the following mathematical formula: the resulting LCS concentration shall be divided by the known analyte concentration, which will then be multiplied by one hundred [(LCS concentration / known analyte concentration) * 100]. If the LCS results fall outside of the acceptance limits, then a testing laboratory cannot verify that it is able to acceptably perform the analysis in a clean matrix. A failing LCS may be re-analyzed once. If the results of the re-analysis also fall outside of the acceptance limits, then all samples associated with the LCS must be re-prepared and re-analyzed, along with all other appropriate analysis batch QC samples;

(III) A matrix spike with a recovery greater than or equal to seventy percent (= 70%) and less than or equal to one hundred and thirty percent (= 130%) of expected values;

(IV) A matrix spike duplicate that results in a relative percent difference that is less than or equal to thirty percent (RPD = 30%) for all mycotoxin analytes resulting in concentrations greater than (>) the LOQ; and

(V) Continuing calibration verification (CCV) with a recovery greater than or equal to seventy percent (= 70%) and less than or equal to one hundred and thirty percent (= 130%) of expected values. A CCV sample is required at the beginning of an analytic run, every twenty (20) samples, and at the end of the run.

(ii)Instrument QC. New calibrations must be accurately verified in the lower twenty-five percent (25%) of the calibration curve using second source certified reference materials (CRM) or a second preparation. Recoveries must be greater than or equal to seventy percent (= 70%) and less than or equal to one hundred and thirty percent (= 130%) of expected values.

(F)Calibration criteria. Calibrations shall include the following requirements:

(i) Testing laboratories may use commercially available CRM calibration standards or those prepared by the laboratory. Commercially available calibration standards shall only be used according to the manufacturer's instructions. All calibration standards shall be used before their date of expiration;

(ii) Data that is above the highest retained calibrator shall not be reported without qualification;

(iii) Gravimetric dilution shall be used to determine dilution factors for standards and shall be reported in grams per gram (g/g);

(iv) Matrix matching or surrogate matrix shall be used in calibration standards;

(v) Five (5) levels of linear or weighted linear regression, or six (6) levels of quadradic regression, using an average response factor;

(vi) A coefficient of determination that is greater than or equal to ninety-nine hundredths (R 2 = 0.99) and a relative standard error that is less than thirty percent (RSE < 30%); and

(vii) The calibration curve shall not be manipulated so that it artificially passes through zero.

(G)Reporting results. Mycotoxin analytes shall be reported to three (3) significant figures, using the unit parts per billion (ppb).

(3)Residual solvents. Production batch samples shall be tested for residual solvent analytes in accordance with the following:

(A)Allowable thresholds. Samples shall be tested for the following residual solvent analytes and shall be less than (<) the allowable threshold, in parts per million (ppm), listed below. If the cannabis concentrate used to make an infused product was tested for residual solvents and test results indicate the lot was within established limits, then the infused product does not require additional testing for residual solvent analytes.

(i) Acetone < 1000 ppm;

(ii) Benzene < 2 ppm;

(iii) Butane < 1000 ppm;

(iv) Ethanol < 5000 ppm (required for inhaled products only);

(v) Ethyl acetate < 1000 ppm;

(vi) Heptane < 1000 ppm;

(vii) Hexane < 60 ppm;

(viii) Methanol < 600 ppm;

(ix) Pentane < 1000 ppm;

(x) Propane < 1000 ppm;

(xi) Isopropyl Alcohol < 1000 ppm;

(xii) Toluene < 180 ppm; and

(xiii) Total Xylenes (m, p, o-xylenes) < 430 ppm.

(B)Instrumentation. For residual solvent testing, laboratories shall use Headspace Gas Chromatography Flame Ionization Detection (GC-FID) or Headspace Gas Chromatography Mass Spectrometry (GC-MS).

(D)Sample preparation. Sample must weigh greater than or equal to two tenths of a gram (= 0.2 g). The extraction and/or dilution solvent chosen for preparation of standards and samples shall not be included on the analyte list of residual solvents tested for in OAC 442:10-8-1(i)(3)(A). All analytes shall be soluble in the extraction and/or dilution solvent. Background levels of contamination from laboratory solvents shall be controlled and shall be below the allowable threshold for each solvent.

(E)Laboratory quality control (LQC) requirements.

(i)LQC samples. The following LQC samples must be run with each analytic run, and repeated every twenty (20) samples in an analytic run and must include:

(I) A method blank with a resulting value that is less than or equal to the limit of quantification (= LOQ);

(III) A matrix spike with a recovery greater than or equal to seventy percent (=70%) and less than or equal to one hundred and thirty percent (= 130%) of expected values;

(IV) A matrix spike duplicate that results in a relative percent difference that is less than or equal to twenty percent (RPD = 20%) for all residual solvent analytes resulting in concentrations greater than (>) the LOQ; and

(V) Continuing calibration verification (CCV) with a recovery that is greater than or equal to eighty percent (= 80%) and less than or equal to one hundred and twenty percent (= 120%) of expected values. A CCV sample is required at the beginning of an analytic run, every twenty (20) samples, and at the end of the run.

(ii)Instrument QC. New calibrations must be accurately verified using second source certified reference materials (CRM) or a second preparation in the lower twenty-five percent (25%) of the calibration curve. Recoveries must be greater than or equal to eighty percent (= 80%) and less than or equal to one hundred and twenty percent (= 120%).

(F)Calibration criteria. Calibrations shall include the following requirements:

(ii) Data that is above the highest retained calibrator shall not be reported without qualification;

(iii) Gravimetric dilution shall be used to determine dilution factors for standards and shall be reported in grams per gram (g/g);

(iv) Five (5) levels of linear or weighted linear regression, or six (6) levels of quadradic regression, using an average response factor;

(v) A coefficient of determination that is greater than or equal to nine hundred and ninety-five thousandths (R 2 = 0.995) and a relative standard error that is less than twenty-five percent (RSE < 25%); and

(vii) The calibration curve shall not be manipulated so that it artificially passes through zero (0).

(G)Reporting results. Residual solvent analytes shall be reported to three (3) significant figures using the unit parts per million (ppm). Integration type and QC integration must correspond to the calibration integration. Peaks shall be integrated from baseline to baseline and non-resolved peaks shall be split peak at the valley minimum.

(4)Heavy metals. Harvest batch samples and production batch samples shall be tested for heavy metal analytes in accordance with the following:

(A)Allowable thresholds. Samples shall be tested for the following heavy metal analytes and shall be less than (<) the allowable threshold, in parts per million (ppm), as determined by the product form listed below:

(i) Inhaled product, administration by metered dose nasal spray, or pressurized metered dose inhaler medical marijuana and medical marijuana products shall be tested for the following heavy metal analytes and shall be less than the associated allowable thresholds:

(I) Arsenic < 0.2 ppm;

(II) Cadmium < 0.2 ppm;

(III) Lead < 0.5 ppm; and

(IV) Mercury < 0.1 ppm.

(ii) Topical and transdermal medical marijuana and medical marijuana products shall be tested for the following heavy metal analytes and shall be less than the associated allowable thresholds:

(I) Arsenic < 3 ppm;

(II) Cadmium < 3 ppm;

(III) Lead < 10 ppm; and

(IV) Mercury < 1 ppm.

(iii) Oral consumption, rectal, or vaginal administration medical marijuana and medical marijuana products shall be tested for the following heavy metal analytes and shall be less than the associated allowable thresholds:

(I) Arsenic < 1.5 ppm;

(II) Cadmium < 0.5 ppm;

(III) Lead < 1 ppm; and

(IV) Mercury < 1.5 ppm.

(iv) If the cannabis concentrate used to make an infused product was tested for heavy metals and test results indicate the batch was within established limits, then the infused product does not require additional testing for heavy metal analytes. However, noninfused pre-rolls and infused pre-rolls must still undergo additional testing for heavy metal analytes.

(B)Instrumentation. For heavy metal analyte testing, laboratories shall use Inductively Coupled Plasma Mass Spectrometry (ICP-MS) equipped with collision reaction cell technology. For sample preparation, a closed vessel microwave digestion system capable of reaching two hundred and ten degrees Celsius (210 °C), or a hot plate capable of reaching ninety-five degrees Celsius (95 °C) for one (1) hour, are required.

(C)Methodologies. A testing laboratory's method must pass a matrix proficiency test as required by the Authority. The Authority will conduct the matrix proficiency test and will supply medical marijuana samples with known analyte concentration values. Passing values must be within plus or minus two and a half on a standard deviation index (± 2.5 SDI). All internally developed methods shall comply with AOAC Standard Method Performance Requirements (SMPR) 2020.001. For Determination of Heavy Metals in a Variety of Cannabis and Cannabis-Derived Products. (2020);

(D)Sample preparation. Samples must weigh greater than or equal to five tenths of a gram (= 0.5 g). Internal Standards must be used for all analytes. Recovery of internal standards must be greater than or equal to fifty percent (= 50%) and less than or equal to two hundred percent (= 200%). A fifteen (15) minute pre-digestion is required to initiate the breakdown of hydrocarbons. If microwave digestion is used, a determination of seal integrity is required. If the post weight loss of the sample exceeds one percent (1%) of the pre-weight of the sample and reagents, the sample is considered compromised, and a new digestion must be performed. Glass vials must be acid washed before use. Concentrated ultrapure, or equivalent nitric acid (HNO₃) shall be used for sample digestion and concentrated ultrapure, or equivalent hydrochloric acid (HCl) shall be used for mercury stabilization. The diluent for sample preparation shall be determined by the following formula: one to five percent volume per volume HNO₃ and five tenths percent volume by volume HCl solution in deionized water with a resistance greater than eighteen megaohms per centimeter [1% - 5% (v/v) HNO 3 / 0.5% (v/v) HCl solution in DI Water (Resistance > 18 M*cm)]. The rinse blank solution shall be prepared on the same day as analysis and shall be determined by the following formula: one to five percent volume per volume HNO₃ and five tenths percent HCl solution in deionized water with a resistance greater than eighteen megaohms per centimeter [1% - 5% (v/v) HNO₃ / 0.5% HCl solution in DI Water (Resistance > 18 M*cm)]. When mercury analysis is performed, gold shall be added to the rinse blank, calibrators, samples, and LQC samples to a concentration of a hundred micrograms per liter (100 µg/L).

(E)Laboratory quality control (LQC) requirements.

(i)LQC samples. The following LQC samples must be run with each analytic run, and repeated every twenty (20) samples in an analytic run and must include:

(I) A method blank with a resulting value that is less than the limit of quantification (< LOQ);

(III) A matrix spike with a recovery greater than or equal to eighty percent (= 80%) and less than or equal to one hundred twenty percent (= 120%) of expected values;

(IV) A matrix spike duplicate that results in a relative percent difference that is less than or equal to twenty percent (RPD = 20%) for all heavy metal analytes resulting in concentrations greater than (>) the LOQ; and

(V) Continuing calibration verification (CCV) with a recovery greater than or equal to eighty-five percent (= 85%) and less than or equal to one hundred and fifteen percent (= 115%) of expected values. A CCV sample is required at the beginning of an analytic run, every twenty (20) samples, and at the end of the run.

(ii)Instrument QC. New calibrations must be accurately verified using second source certified reference materials (CRM) or a second preparation targeting the lower twenty-five percent (25%) of the calibration curve. Recoveries must be greater than or equal to eighty-five percent (= 85%) and less than or equal to one hundred and fifteen percent (= 115%).

(F)Calibration criteria. Calibrations shall include the following requirements:

(ii) A minimum of three replicate integrations are required for each analyte;

(iii) Data that is above the highest retained calibrator shall not be reported without qualification;

(iv) Gravimetric dilutions shall be used to determine dilution factors for standards and shall be reported in grams per gram (g/g);

(v) Five (5) levels of linear or weighted linear regression; and

(vi) A coefficient of determination that is greater than or equal to nine hundred and ninety-five thousandths (R 2 = 0.995) and a relative standard error that is less than twenty-five percent (RSE < 25%).

(G)Reporting results. Heavy metal analytes shall be reported to three (3) significant figures, using the unit ppm and on a dry weight basis, for samples that require reporting moisture results, as determined by the following equation: the moisture concentration of the sample as it was received, divided by the percent moisture of the sample subtracted from one hundred, multiplied by one hundred, equals the corrected moisture concentration dry weight ([("As received" concentration) / (100 - % moisture)] x 100 = corrected moisture concentration dry weight).

(5)Pesticide residue. Harvest batch samples and production batch samples shall be tested for pesticide analytes in accordance with the following:

(A)Allowable thresholds. Samples shall be tested for the following pesticide analytes and shall be less than (<) the allowable threshold, in parts per million (ppm), listed below:

(i) Abamectin (B1a & B1b) < 0.5 ppm;

(ii) Azoxystrobin < 0.2 ppm;

(iii) Bifenazate < 0.2 ppm;

(iv) Etoxazole < 0.2 ppm;

(v) Imazalil < 0.2 ppm;

(vi) Imidacloprid < 0.4 ppm;

(vii) Malathion < 0.2 ppm;

(viii) Myclobutanil < 0.2 ppm;

(ix) Permethrins (cis & trans) < 0.2 ppm;

(x) Spinosad (mixture of A and D) < 0.2 ppm;

(xi) Spiromesifen < 0.2 ppm;

(xii) Spirotetramat < 0.2 ppm; and

(xiii) Tebuconazole < 0.4 ppm.

(B)Instrumentation. For pesticide analyte testing, laboratories shall use LC-MS/MS with ESI or LC-MS/MS with APCI.

(C)Methodologies. The method employed by a testing laboratory must pass a matrix proficiency test as required by the Authority. The Authority will conduct the matrix proficiency test and will supply medical marijuana samples with known analyte concentration values. Passing values must be within plus or minus two and a half on a standard deviation index (± 2.5 SDI).

(D)Sample preparation. Sample must weigh greater than or equal to five tenths of a gram (= 0.5 g). Sample preparation solvents must be LC-MS grade. Internal standards must be used for all analytes. Solid form samples shall be homogenized by blending, using a food processor or similar apparatus, or cryogrinding. Liquid form samples shall be homogenized by stirring. Analytes shall be extracted from the sample using the following techniques: solid-liquid extraction or solid phase extraction.

(E)Laboratory quality control (LQC) requirements.

(i)LQC samples. The following LQC samples must be run with each analytic run, and repeated every twenty (20) samples in an analytic run and must include:

(I) A method blank with a resulting value that is less than or equal to the limit of quantification (= LOQ);

(III) A matrix spike with a recovery greater than or equal to seventy percent (= 70%) and less than or equal to one hundred thirty percent (= 130%) of expected values;

(IV) A matrix spike duplicate that results in a relative percent difference that is less than or equal to thirty percent (RPD = 30%) for all pesticide residue analytes resulting in concentrations greater than (>) the LOQ; and

(ii)Instrument QC. New calibrations must be accurately verified using second source certified reference materials (CRM) or a second preparation targeting the lower twenty-five percent (25%) of the calibration curve. Recoveries must be greater than or equal to seventy percent (= 70%) and less than or equal to one hundred and thirty percent (= 130%) of expected values.

(F)Calibration criteria. Calibrations shall include the following requirements:

(ii) Data that is above the highest retained calibrator shall not be reported without qualification;

(iii) Gravimetric dilution shall be used to determine dilution factors for standards and shall be reported in grams per gram (g/g);

(iv) Matrix matching or a surrogate matrix shall be used in calibration standards; and

(v) Internal standards with a correction factor that is greater than or equal to fifty percent (= 50%) and less than or equal to two hundred percent (= 200%);

(vi) Five (5) levels of linear or weighted linear regression, or six (6) levels of quadratic regression;

(vii) A coefficient of determination that is greater than or equal to ninety-nine hundredths (R 2 = 0.99) and a relative standard error that is less than thirty percent (RSE < 30%); and

(viii) The calibration curve shall not be manipulated so that it artificially passes through zero (0).

(G)Reporting results. Pesticide analytes shall be reported to three (3) significant figures, using the unit parts per million. Samples that require moisture analysis shall be reported on a dry weight basis as determined by the following equation: the moisture concentration of the sample as it was received, divided by the percent moisture of the sample subtracted from one hundred, multiplied by one hundred, equals the corrected moisture concentration dry weight ([("As received" concentration) / (100 - % moisture)] x 100 = corrected moisture concentration dry weight).

(H)Positive identification. Positive identification of pesticide analytes using LC-MS/MS shall be deemed accurate only if there is a qualifier ion in transition; and the peak area ratio (quantitation transition/qualification transition) of the samples is within plus or minus fifty percent (± 50%) of the peak area ratio (quantitation transition/qualification transition) of the calibrator.

(6)THC and cannabinoid concentration. Harvest batch samples and production batch samples shall be tested for THC and cannabinoid concentration in accordance with the following:

(A)Cannabinoid analytes. Samples shall be tested for cannabinoid analytes including, but not limited to, the following:

(i) Cannabichromene (CBC);

(ii) Cannabidiol (CBD);

(iii) Cannabidiol acid (CBDA);

(iv) Cannabigerol (CBG);

(v) Cannabigerolic acid (CBGA);

(vi) Cannabinol (CBN);

(vii) Delta-8-tetrahydrocannabinol ([DELTA]-8-THC);

(viii) Delta-9-tetrahydrocannabinol ([DELTA]-9-THC);

(ix) Tetrahydrocannabinolic acid (THCA); and

(x) Tetrahydrocannabivarin (THCV).

(B)Total cannabinoid concentrations. Samples shall be tested for total cannabinoid analyte concentrations in accordance with the following:

(i) Total [DELTA]-9-THC concentration shall be determined by combining the THCA and [DELTA]-9-THC concentrations using the following calculation: the THCA concentration as expressed in milligrams per gram multiplied by eight hundred and seventy-seven thousandths plus the [DELTA]-9-THC concentration expressed in milligrams per gram is equal to the total [DELTA]-9-THC concentration as expressed in milligrams per gram [(THCA concentration (mg/g) x 0.877) + [DELTA]-9-THC concentration (mg/g) = total [DELTA]-9-THC concentration (mg/g)]; and

(ii) When the acidic form and the decarboxylated form of a cannabinoid are both detected, the total concentration for that cannabinoid shall be determined using the following calculation: the concentration of the cannabinoid's acidic form, expressed in milligrams per gram, multiplied by eight hundred and seventy-seven thousandths plus the concentration of the decarboxylated form, expressed in milligrams per gram equals the total concentration, as expressed in milligrams per gram, for that cannabinoid. [(acidic form [cannabinoid] concentration (mg/g) x 0.877) + decarboxylated form [cannabinoid] concentration (mg/g) = total [cannabinoid] concentration (mg/g)].

(C)Instrumentation. For THC and cannabinoid concentration testing, laboratories shall use Liquid Chromatography Diode Array Detection (LC-DAD), LC-MS or Liquid Chromatography Ultraviolet (LC-UV).

(D)Methodologies. The method employed by a testing laboratory must pass a matrix proficiency test as required by the Authority. The Authority will conduct the matrix proficiency test and will supply medical marijuana samples with known analyte concentration values. Passing values must be within plus or minus two and a half on a standard deviation index (± 2.5 SDI).

(E)Laboratory quality control (LQC) requirements.

(i)LQC samples. The following LQC samples must be run with each analytic run, and repeated every twenty (20) samples in an analytic run and must include:

(I) A method blank with a resulting value that is less than or equal to the limit of quantification (= LOQ);

(III) A matrix spike with a recovery greater than or equal to eighty percent (= 80%) and less than or equal to one hundred and twenty percent (= 120%) of expected values;

(IV) A matrix spike duplicate that results in a relative percent difference that is less than or equal to twenty percent (RPD = 20%) for all cannabinoid analytes resulting in concentrations greater than (>) the LOQ; and

(ii)Instrument QC. New calibrations must be accurately verified using second source certified reference materials (CRM) or a second preparation. Recoveries must be greater than or equal to eighty-five percent (= 85%) and less than or equal to one hundred and fifteen percent (= 115%) of expected values.

(F)Calibration criteria. Calibrations shall include the following requirements:

(ii) Data that is above the highest retained calibrator shall not be reported without qualification;

(iii) Gravimetric dilution shall be used to determine dilution factors for standards and shall be reported in grams per gram (g/g);

(iv) Five (5) levels of linear or weighted linear regression;

(G)Reporting results. Cannabinoid analytes shall be reported to three (3) significant figures. Samples that require moisture analysis shall be reported on a dry weight basis as determined by the following equation: the moisture concentration of the sample as it was received, divided by the percent moisture of the sample subtracted from one hundred, multiplied by one hundred, equals the corrected moisture concentration dry weight ([("As received" concentration) / (100 - % moisture)] x 100 = corrected moisture concentration dry weight).

(H)Peak integration. Integration type and QC integration must correspond to the calibration integration. Peaks shall be integrated from baseline to baseline and non-resolved peaks shall be split peak at the valley minimum.

(I)Total [DELTA]-9-THC concentration acceptance criteria. If a sample of medical marijuana flower has a total [DELTA]-9-THC concentration of greater than or equal to thirty percent (= 30%) or if a distillate sample has a total [DELTA]-9-THC concentration of greater than or equal to ninety percent (= 90%), the following requirements shall apply before those results are reported:

(i) For medical marijuana flower with a total [DELTA]-9-THC concentration that is:

(I) Greater than or equal to thirty percent (= 30%) total [DELTA]-9-THC concentration, and less than thirty-two and five tenths percent (< 32.5%) total [DELTA]-9-THC concentration, it must be retested using the primary sample. If the retest results are within plus or minus fifteen percent (± 15%) of the original results, the higher of the two results shall be reported. If the retest results are not within plus or minus fifteen percent (± 15%) of the original results, a third test must be performed. A median value of all three (3) test results shall be reported. If retesting under this subsection results in a value greater than or equal to thirty-two and five tenths percent (= 32.5%) total [DELTA]-9-THC concentration, results may not be reported under this subunit and (II) of this unit applies; or

(II) Greater than or equal to thirty-two and five tenths percent (= 32.5%) [DELTA]-9-THC concentration, the Authority will collect a new primary and reserve sample from the source batch. The Authority will conduct testing for total [DELTA]-9-THC concentration using the original reserve sample and the new primary sample. If both retest results are within plus or minus fifteen percent (± 15%) original results, the original results shall be reported. If the retest on the original reserve sample results in a value that is not within plus or minus fifteen percent (± 15%) of the original concentration, the Authority may refer the matter for further investigation. If the retest on the new primary sample results in a value that is not within plus or minus fifteen percent (± 15%) of the original results, the testing laboratory must retest using the new reserve sample and report those results. Testing values generated by the Authority shall not be reported in place of testing laboratory results.

(ii) For medical marijuana distillate with a total [DELTA]-9-THC concentration that is:

(I) Greater than or equal to ninety percent (= 90%) and less than ninety-five percent (< 95%) total [DELTA]-9-THC concentration, it must be retested using the primary sample. If the retest results are within plus or minus ten percent (± 10%) of the original results, the higher of the two results shall be reported. If the retest results are not within plus or minus ten percent (± 10%) of the original results, a third test must be performed. A median value of all three (3) test results shall be reported. If retesting under this subsection results in a value that is greater than or equal to ninety-five percent (= 95%) total [DELTA]-9-THC concentration, results may not be reported under this subunit and (II) of this unit applies; or

(II) Greater than or equal to ninety-five percent (= 95%) [DELTA]-9-THC concentration, the Authority will collect a new primary and reserve sample from the source batch. The Authority will conduct testing for total THC concentration using the original reserve sample and the new primary sample. If both retest results are within plus or minus ten percent (± 10%) original results, the original results shall be reported. If the retest on the original reserve sample results in a value that is not within plus or minus ten percent (± 10%) of the original concentration, the Authority may refer the matter for further investigation. If the retest on the new primary sample results in a value that is not within plus or minus ten percent (± 10%) of the original results, the testing laboratory must retest using the new reserve sample and report those results. Testing values generated by the Authority shall not be reported in place of testing laboratory results.

(7)Terpenoid type and concentration. Harvest batch samples and production batch samples shall be tested for terpenoid type and concentration in accordance with the following:

(A)Terpene analytes. Samples shall be tested for terpene analytes including, but not limited to, the following:

(i) alpha-Bisabolol (á-Bisabolol);

(ii) beta-Caryophyllene (â-Caryophyllene);

(iii) Caryophyllene oxide;

(iv) Eucalyptol;

(v) alpha-Humulene (á-Humulene);

(vi) Limonene;

(vii) Linalool;

(viii) beta-Myrcene (â-Myrcene);

(ix) cis-Nerolidol;

(x) trans-Nerolidol;

(xi) alpha-Pinene (á-Pinene);

(xii) beta-Pinene (â-Pinene); and

(xiii) alpha-Terpinene (á-Terpinene).

(B)Instrumentation. For terpene analyte testing, laboratories shall use GC-MS or GC-FID.

(C)Sample preparation. Sample must weigh greater than or equal to two tenths of a gram (= 0.2 g).

(E)Laboratory quality control (LQC) requirements.

(i)LQC samples. The following LQC samples must be run with each analytic run, and repeated every twenty (20) samples in an analytic run and must include:

(I) A method blank with a resulting value that is less than or equal to the limit of quantification (= LOQ);

(III) A matrix spike with a recovery greater than or equal to eighty percent (= 80%) and less than or equal to one hundred and twenty percent (= 120%) of expected values;

(IV) A matrix spike duplicate that results in a relative percent difference that is less than or equal to twenty percent (RPD = 20%) for all terpenoid analytes resulting in concentrations greater than (>) the LOQ; and

(ii)Instrument QC. New calibrations must be accurately verified using second source certified reference materials (CRM) or a second preparation that targets the lower twenty-five percent (25%) of the calibration curve. Recoveries must be greater than or equal to eighty-five percent (= 85%) and less than or equal to one hundred and fifteen percent (= 115%) of expected values.

(F)Calibration criteria. Calibrations shall include the following requirements:

(ii) Data that is above the highest retained calibrator shall not be reported without qualification;

(iii) Gravimetric dilution shall be used to determine dilution factors for standards and shall be reported in grams per gram (g/g);

(iv) Five (5) levels of linear regression or six (6) levels of quadratic regression;

(v) A coefficient of determination that is greater than or equal to ninety-eight hundredths (R² = 0.98) for linear regression. For quadratic regression, a coefficient of determination that is greater than or equal to ninety-nine hundredths (R² = 0.99) is required; and

(iv) The calibration curve shall not be manipulated so that it artificially passes through zero (0).

(G)Reporting results. Terpenoid analytes shall be reported to three (3) significant figures. Samples that require moisture analysis shall be reported on a dry weight basis as determined by the following equation: the moisture concentration of the sample as it was received, divided by the percent moisture of the sample subtracted from one hundred, multiplied by one hundred, equals the corrected moisture concentration dry weight ([("As received" concentration) / (100 - % moisture)] x 100 = corrected moisture concentration dry weight).

(H)Positive identification. The standard addition method or analyzing the sample on a secondary column shall be used to demonstrate analyte recovery for GC-FID methods. Positive identification of a terpenoid analyte using GC-MS requires the presence of the target ions and all qualifier ions.

(8)Foreign materials and filth. Harvest batch samples and production batch samples shall be tested for foreign materials and filth in accordance with the following:

(A)Allowable thresholds. Foreign materials and filth are contaminants that 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. Samples shall be tested for foreign material and filth contaminants in accordance with the following:

(i)Organic contaminants. Foreign organic material shall be less than or equal to two percent (= 2%) by weight of each sample; and

(ii)Inorganic contaminants. Inorganic material, including but not limited to plastic, glass, and metal shavings, shall not be present in a sample.

(B)Methodologies. The method employed by a testing laboratory must pass a matrix proficiency test as required by the Authority. The Authority will conduct the matrix proficiency test and will supply medical marijuana samples with known analyte concentration values. Passing values must be within plus or minus two and a half on a standard deviation index (± 2.5 SDI).

(C)Reporting results. Results shall be reported as passing or failing.

(9)Water activity and moisture content. Harvest batch samples shall be tested to determine the level of water activity and the percentage of moisture content in accordance with this subsection. This subsection shall not apply to harvest batches that are flash frozen.

(A)Sample preparation. Sample must weigh greater than or equal to five tenths of a gram (= 0.5 g).

(B)Water activity. Samples shall be tested to determine the level of water activity in accordance with the following:

(i)Allowable thresholds. A harvest batch sample shall be deemed to have passed water activity testing if the water activity is less than or equal to sixty-five hundredths (= 0.65 a_w).

(ii)Instrumentation. Testing laboratories shall use a water activity calibrated measurement system capable of a measurement resolution of one thousandth water activity (0.001 a_w) with an accuracy of plus or minus five thousandths water activity (± 0.005 a_w), with a measurement range of at least four tenths to eight tenths water activity (0.40 to 0.80 a_w), and capable of a temperature measurement resolution of one tenth degree Celsius (0.1 °C) with an accuracy of one tenth degree Celsius (0.1 °C).

(iii)Methodologies. The method employed by a testing laboratory must pass a matrix proficiency test as required by the Authority. The Authority will conduct the matrix proficiency test and will supply medical marijuana samples with known analyte concentration values. Passing values must be within plus or minus two and a half on a standard deviation index (± 2.5 SDI).

(iv)Laboratory quality control (LQC) samples. The following LQC samples must be run once per day in an analytic run and must include:

(I) A sample replicate that results in a relative percent difference that is less than or equal to five percent (RPD = 5%); and

(II) Continuing calibration verification (CCV) with a recovery greater than or equal to ninety-five percent (= 95%) and less than or equal to one hundred and five percent (= 105%) of expected values.

(v)Reporting results. Results shall be reported to two (2) decimal places, using the unit water activity (a_w).

(C)Moisture content. Samples shall be tested to determine the percentage (%) of moisture content in accordance with the following:

(i)Allowable thresholds. A harvest batch sample shall be deemed to have passed moisture content testing if the moisture content is less than or equal to fifteen percent (= 15.0%) of the dry weight of the sample.

(ii)Instrumentation. To test the moisture content of a sample, laboratories shall use an oven for the loss on drying technique, a moisture analyzer, or the Karl Fischer technique.

(iv)Laboratory quality control (LQC) samples when using the loss on drying technique or a moisture analyzer. The following LQC samples shall be run once per day in an analytic run and shall include:

(I) A laboratory duplicate sample that results in a relative percent difference that is less than or equal to twenty percent (RPD = 20%); and

(II) A continuing calibration verification (CCV) to verify the laboratory balance used by using a calibrated weight set, result must be less than or equal to one tenth percent (= 0.1%) difference from assigned mass.

(v)Laboratory quality control (LQC) samples when using the Karl Fischer technique. The following LQC samples shall be run once per day in an analytic run and shall include:

(I) A method blank with a resulting value that is less than or equal to the limit of quantification (= LOQ);

(II) A laboratory duplicate sample that results in a relative percent difference that is less than or equal to ten percent (RPD = 10%);

(III) A continuing calibration verification (CCV) that shows that the water standard is within the stated criteria for the standard used; and

(IV) Instrument QC, titer shall be determined following the manufacturer's instructions and recommendations.

(vi)Reporting results. Results shall be reported to three (3) significant figures indicating the percentage of moisture content by dry weight in the sample.

(k)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.

(l)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 Rules; or

(B) If it is not or cannot be remediated or decontaminated under these Rules, it must be disposed of 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 and as set forth in Appendix F. 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 442:10-8-1(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 microbial 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 decontaminated. 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 Authority 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.

(m)Remediation, decontamination, and retesting, microbial testing.

(1) If a sample from a harvest batch or production batch fails microbial 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 microbial testing to a processor and only for the purpose of remediation. The processor shall either 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 442:10-8-1(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, provided the harvest batch was not processed into a solvent-based concentrate.

(3) If a sample from a batch of a cannabinoid concentrate or extract exceeds a microbial analyte allowable threshold, 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 in the following manner:

(A) A batch that has failed microbial testing at a testing laboratory, that is decontaminated in accordance with this Subsection must be tested for microbials, heavy metals, THC and cannabinoid concentration, terpenoid type and concentration. And must be tested for pesticide residue, foreign material and filth, and water activity and moisture content if not previously tested.

(B) A batch that has failed for microbials during a grower's inspection, that is decontaminated in accordance with this Subsection must be tested for microbials, heavy metals, pesticide residue, THC and cannabinoid concentration, terpenoid type and concentration, foreign materials and filth, and water activity and moisture content.

(C) A batch that is remediated in accordance with this Subsection by processing into a solvent based concentrate must be tested for THC and cannabinoid concentration, terpenoid type and concentration, microbials, residual solvents, heavy metals, and pesticides.

(5) A batch that fails microbial testing after undergoing a decontamination process in accordance with subsection (1) or (2) of this section must be disposed of in accordance with the Oklahoma Medical Marijuana Waste Management Act, 63 O.S. § 427a et seq., and these Rules.

(n)Decontamination and retesting, residual solvent testing.

(1) If a sample from a batch fails residual solvent 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 this section must be sampled and retested for residual solvents in accordance with these Rules.

(3) A batch that fails residual solvent testing and is not decontaminated or is decontaminated and fails retesting must be disposed of in accordance with the Oklahoma Medical Marijuana Waste Management Act, 63 O.S. § 427a et seq., and these Rules.

(o)Decontamination and retesting, foreign materials and filth testing.

(1) If a sample from a batch of usable marijuana fails foreign materials and filth testing, the batch from which the sample was taken may be remediated to reduce the amount of foreign materials and filth to below action levels.

(2) A batch that undergoes decontamination as described in this section must be sampled and tested in accordance with these Rules.

(p)Remediation, decontamination and retesting, pesticide testing.

(1) If a sample from a batch fails pesticide testing, the batch may not be remediated or decontaminated and must be disposed of in accordance with the Oklahoma Medical Marijuana Waste Management Act, 63 O.S. § 427a et seq., and these Rules.

(2) The Authority may report to the Oklahoma Department of Agriculture all test results showing samples failing pesticide testing.

(q)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 of in accordance with the Oklahoma Medical Marijuana Waste Management Act, 63 O.S. § 427a et seq., and these Rules.

(2) The Authority may report to the Oklahoma Department of Environmental Quality all test results showing samples failing heavy metals testing.

(r)Remediation, decontamination and retesting, mycotoxin testing. If a sample from a batch fails mycotoxins testing, the batch may not be remediated or decontaminated and must be disposed of in accordance with the Oklahoma Medical Marijuana Waste Management Act, 63 O.S. § 427a et seq., and these Rules.

(s)Decontamination and 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 this section must be sampled and tested in accordance with these Rules. If the harvest batch passed initial testing for residual solvents, heavy metals, and/or pesticides, then the harvest batch does not require additional testing for those testing categories.

(3) If a harvest batch that fails microbial testing and water activity and/or moisture content testing, the harvest batch does not need to be further dried and cured by the grower before being transferred to a processor for remediation in accordance with OAC 442:10-8-1(l).

(t)Testing of pre-rolls, kief, shake and trim.

(1)Pre-rolls. Pre-rolls may be created in accordance with the following:

(A)Noninfused pre-rolls. Growers, processors, and dispensaries may create noninfused pre-rolls from flower, shake, or trim collected from single harvest or multiple harvest batches. For multiple harvest batches, provided all batches have passed all testing requirements under this Subchapter, the plant material must be homogenized into a new batch that weighs less than or equal to fifteen (= 15) pounds. Multiple harvest batch noninfused pre-rolls are subject to the same testing requirements of a harvest batch under OAC 442:10-8-1(j). For single harvest batch noninfused pre-rolls made from flower, shake or trim that has passed full compliance testing, growers, processors, or dispensaries must conduct additional testing on the pre-rolls only for heavy metals, THC and cannabinoid concentration, and foreign materials and filth.

(B)Infused pre-rolls. Only processors may create infused pre-rolls. Infused pre-rolls must be tested for microbials, mycotoxins, residual solvents, heavy metals, pesticide residue, THC and cannabinoid concentration, terpenoid type and concentration, and water activity and moisture content. If medical marijuana concentrate, that has previously passed residual solvent testing, is used to infuse the pre-roll, residual solvent is not required.

(2)Kief. Growers and processors may collect kief from multiple harvest batches, provided those harvest batches have passed all testing requirements under this Subchapter. The kief must be homogenized into a new batch that weighs less than or equal to fifteen (= 15) pounds. Kief collected by a grower or processor is subject to the same testing requirements of a harvest batch under OAC 442:10-8-1(i).

(3)Shake and trim. Growers and processors may collect shake and trim from multiple harvest batches provided those harvest batches have passed all testing requirements under this Subchapter. The shake and trim must be homogenized into a new batch that weighs less than or equal to fifty (= 50) pounds. Shake and trim collected by a grower or processor is subject to the same testing requirements of a harvest batch under OAC 442:10-8-1(i).

Okla. Admin. Code § 442:10-8-6.1

Adopted by Oklahoma Register, Volume 41, Issue 3, October 16, 2023, eff. 9/11/2023, exp. 9/14/2024 (Emergency)