Section 691-5-6 - Testing of Cannabis and Cannabis ProductsSection 6.1 - Mandatory Testing Required An adult use cannabis licensee may not sell or distribute adult use cannabis or an adult use cannabis product to a cannabis store for sale to a consumer unless the cannabis or cannabis product has been tested pursuant to this Rule and that mandatory testing has demonstrated that the cannabis or cannabis product does not exceed the maximum level of allowable contamination for any contaminant that is injurious to health and for which testing is required, except that OCP may temporarily waive mandatory testing requirements under this section for any contaminant or factor for which OCP has determined that there exists no licensed cannabis testing facility in the state capable of and certified to perform such testing.
Section 6.2 - Mandatory Testing and Additional Analysis Cannabis and cannabis products must be tested in accordance with this Rule. OCP or a client may request additional analyses which will be specified by the cannabis testing facility in the written sampling plan.
A. The following tests are mandatory for all cannabis or cannabis products, except seedlings, immature cannabis plants and seeds, prior to being transferred to a cannabis store for sale to a consumer: (1)Filth and foreign material. Any visible contaminant, including without limitation hair, insects, feces, mold, sand, soil, cinders, dirt, packaging contaminants and manufacturing waste and byproducts.(2)Residual solvents, poisons and toxins. Acetone, acetonitrile, butane, ethanol, ethyl acetate, ethyl ether, heptane, hexane, isopropyl alcohol, methanol, pentane, propane, toluene, total xylenes (m, p, o-xylenes), 1,2-dichloroethane, benzene, chloroform, ethylene oxide, methylene chloride, trichloroethylene and any others used. A cannabis testing facility is not required analyze for residual solvents and processing chemicals in dried flower, kief, hashish or cannabis products manufactured without chemical solvents. A cannabis testing facility is not required to analyze an orally-consumed tincture containing alcohol for residual ethanol. A licensee is not required to test a cannabis product for residual solvents, poisons and toxins if all cannabis concentrate used to make the cannabis product has previously passed mandatory testing for residual solvents.(3)Pesticides (insecticides, fungicides, herbicides, acaricides, plant growth regulators, disinfectants, etc.). Any pesticide, insecticide, fungicide, herbicide, acaricide, plant growth regulator, disinfectant or any other chemical included as a pesticide in Table 6.8-A. A licensee is not required to test a cannabis concentrate or a cannabis product for pesticides, fungicides, insecticides and growth regulators if all cannabis flower and/or trim used to make the cannabis concentrate or cannabis product has previously passed mandatory testing for pesticides, fungicides, insecticides and growth regulators.(4)Other harmful chemicals (Metals).Cadmium (Cd), lead (Pb), arsenic (As) and mercury (Hg). A licensee is not required to test a cannabis product for the other harmful chemicals listed herein if the cannabis concentrate used to make the cannabis product has previously passed mandatory testing for the other harmful chemicals listed herein.(5)Dangerous molds and mildew. Total yeast and mold, and for any cannabis or cannabis product that fails an initial test for total yeast and mold, mycotoxins including aflatoxins (B1, B2, G1, and G2) and ochratoxin A.(6)Harmful microbes. Total viable aerobic bacteria, total coliforms, Enterobacteriaceae, Shiga toxin-producing E. coli (STEC) and Salmonella (spp.).(7)THC potency, homogeneity and cannabinoid profiles. THC and any other cannabinoid to be referenced in labeling or marketing materials.(8)Water activity. Testing for water activity is mandatory for solid and semi-solid edible cannabis products that do not require preservation by other means (e.g. refrigeration) and for cannabis plant material that is dried and prepared as a product in its final form of intended use and that is to be sold or transferred by a cultivation facility, products manufacturing facility or cannabis store.B. A registered or licensed cultivation facility, registered or licensed products manufacturing facility, registered inherently hazardous extraction facility, registered or exempt caregiver, or registered dispensary may submit for research and development purposes samples of cannabis, but such testing shall not be considered mandatory. Cannabis that is transferred to a cannabis store must still undergo mandatory testing as set forth herein.C. OCP or its designee will publish a best practices guidance document that includes examples of a sampling plan and preservation instructions appropriate to each matrix type.D. A cannabis testing facility must perform, and provide a certificate of analysis for, any test(s) requested by the CDC or OCP on any sample.Section 6.3 - Testing Methodology A. Testing facilities must develop and implement scientifically valid testing methodologies for the chemical, physical and microbial analysis of cannabis and cannabis products. A method validated in accordance with this section is deemed a scientifically valid testing methodology. The cannabis testing facility must not perform testing using a method that has not been validated.B. To the extent practicable, the cannabis testing facility's testing methodologies must comport with the following guidelines:(1) U.S. Food and Drug Administration's Bacterial Analytical Manual, most recent version of target method;(2) AOAC International's Official Methods of Analysis for Contaminant Testing of AOAC International, 21st Edition, 2019;(3) Methods of analysis for contaminant testing published in the United States Pharmacopeia and the National Formulary (USP-NF) most recent version of target method; or(4) If the cannabis testing facility wants to use an alternative scientifically valid testing methodology, the cannabis testing facility must validate the methodology and submit the validation study and standard operating procedure for the new methodology to the CDC.Section 6.4 - Validation of Non-Standard Test Methods or Technologies and Modified Standard Test Methods or Technologies A. The cannabis testing facility may use a nonstandard method, including the use of a technology or instrumentation that is not one of the suggested instrumentations indicated in this rule, and including the use of a cannabis testing facility-designed or -developed method, a standard method used outside its intended scope or an amplification or a modified standard method for the analysis of samples, so long as the cannabis testing facility receives CDC certification for the use of such a nonstandard method.B. The cannabis testing facility must validate a desired method to use for the analysis of samples for each matrix. The cannabis testing facility must use one of the following guidelines, or equivalent methodologies, for validating a method, depending on the type of method:(1) U.S. Food and Drug Administration's Guidelines for the Validation of Methods for the Detection of Microbial Pathogens in Foods and Feeds, 3rd Edition, 2019; or(2) U.S. Food and Drug Administration's Guidelines for the Validation of Chemical Methods for the FDA FVM Program, 3rd Edition, 2019.C. At a minimum, the cannabis testing facility must conduct a level-one (emergency-use) single-cannabis testing facility validation study for all methods for testing for microbiological impurities or chemicals.D. A cannabis testing facility must include and address the criteria listed in Table 6.4-A in the cannabis testing facility's level-one validation study. Table 6.4-A. Microbiological-analysis method validation studies
Criteria | Requirement |
Number of target organisms; inclusivity | 5 |
Number of non-target organisms; exclusivity | 5 |
Number of analyte levels per matrix: Qualitative methods | 3 levels: high and low inoculum levels and 1 uninoculated level |
Number of analyte levels per matrix: Quantitative methods | 4 levels: low, medium and high inoculum levels and 1 uninoculated level |
Replicates per food at each level tested | 2 or more replicates per level |
Reference method comparison | No |
E. For purposes of validating standards for microbiological analysis, the following definitions apply:(1) "Exclusivity" is the specificity of the test method. It evaluates the ability of the method to distinguish the target organisms from similar but genetically distinct non-target organisms.(2) "Inclusivity" is the sensitivity of the test method, meaning its capability to discriminate between measurement responses representing different levels (e.g., concentrations) of a variable of interest. It evaluates the ability of the test method to detect a wide range of target organisms by a defined relatedness.F. For chemical analysis method validation studies: (1) When high-concentration reference standards are available, testing facilities must employ direct spiking of the sample matrix.(2) When high-concentration standards for matrix spiking are unavailable, matrix spikes may be made through post-processing and dilution spiking of samples before analysis, rather than direct samplematrix spike.G. Testing facilities must use reference materials validation studies when cannabis reference materials become available.Section 6.5 - Certificate of Analysis A. For each primary sample of a batch tested, the cannabis testing facility must generate and provide a certificate of analysis to the requester and the CDC within two business days of the completion of the final data review.B. The certificate of analysis must, at a minimum, contain the following information: (1) Cannabis testing facility's name, mailing address and physical address;(2) Sample-identifying information, including matrix type and unique sample identifiers;(3) Sample history, including date collected, date received by the cannabis testing facility, whether the sample was collected by the cannabis testing facility or received from a licensee and date or dates of sample preparations and analyses;(4) If applicable, the identity of the test methods used to analyze cannabinoids, residual solvents, pesticides, microbiological contaminants, mycotoxins, heavy metals and, if applicable, terpenes;(5) If applicable, test results for sample homogeneity; cannabinoids; residual solvents; pesticides; microbiological contamination; and, if applicable, terpenes;(6) The laboratory uncertainty for potency analysis;(7) If applicable, test results for water activity and visual inspection for filth and foreign material;(8) The reporting limit for each analyte tested;(9) The total primary sample weight in grams, reported to three significant figures;(10) Whether the primary sample and batch "passed" or "failed" cannabis testing facility testing;(11) The licensee for whom the testing was performed, including license number, name and source package identification number; and(12) A disclaimer that not all potential/existing hazards were tested.C. The cannabis testing facility must validate the accuracy of the information contained in the certificate of analysis, and the facility director or QAO must sign and date the certificate of analysis.D. In the event that an error is discovered following the issuance of the certificate of analysis, the cannabis testing facility must correct the error through the correction and reissuance of the certificate of analysis to correct the error. The corrected certificate of analysis must state that is a reissued version of a previous certificate of analysis and must include the original sample identifiers as well as the reason for reissuance.E. A cannabis testing facility shall submit electronic data deliverables of all certificates of analysis in the electronic format designated by the CDC in accordance with 10 MRS §9418(2) (A).Section 6.6 - Cannabinoids A. When testing cannabinoid profile, the minimum representative sample size of 0.5 grams is required for all cannabis and cannabis products.B. When testing cannabinoid profile, the cannabis testing facility must minimally test for and report measurements for the following cannabinoids stated in Table 6.6-A: Table 6.6-A. Cannabinoid Potency
Cannabinoid Potency as % of weight |
[DELTA]9-THC |
THCA |
CBD |
CBDA |
Total THC (as sum of THCA and delta-9 THC) |
Total CBD (as sum of CBDA and CBD) |
Note: Testing Facility calculation for Total THC = delta-9 THC + (THCA*0.877) and Total CBD = CBD + (CBDA*0.877).
C. For samples of cannabis flower, non-edible cannabis products and cannabis concentrate, the cannabis testing facility must report, to three significant figures, the concentration in milligrams per gram (mg/g) of the cannabinoids listed in Table 6.6-A. For edible cannabis products, the cannabis testing facility must report, to three significant figures, the concentration in milligrams per serving (mg/serving) and milligrams per package (mg/package) of total THC in the product. The cannabis testing facility must report this information in the certificate of analysis.D. When determining whether a sample of edible cannabis product1 exceeds the 10 mg/serving and 100 mg/package limits, the cannabis testing facility must account for an allowable variance of 10% in accordance with 28-B MRS §703. (1) When determining whether a serving of edible cannabis products exceeds the potency limits, the cannabis testing facility may account for the following variance in the potency in excess of 10 mg/serving:(a) Laboratory uncertainty, not to exceed 5% or 0.5 mg/serving; and(b) An additional 10% allowable variance for edible cannabis products, which cannot exceed 1 mg/serving;(c) For a total maximum allowable potency of 11 mg of Total THC/serving plus laboratory uncertainty which cannot exceed 5% or 0.5 mg/serving;(2) When determining whether a multi-serving package of edible cannabis products exceeds the potency limits, the cannabis testing facility may account for the following variance in the potency in excess of 100 mg/package: (a) Laboratory uncertainty, not to exceed 5% or 5 mg/package; and(b) An additional allowable variance of up to 5 mg/package;(c) For a total maximum potency per multi-serving package of edible cannabis products of 105 mg of Total THC/package plus laboratory uncertainty which cannot exceed 5% or 5 milligrams per multi-serving package.E. When determining whether a sample of edible cannabis product exceeds the 10 mg/serving and 100 mg/package limits required by 28-B MRS §703, the cannabis testing facility must account for laboratory uncertainty, but under no circumstances may such uncertainty exceed 5%.F. The cannabis testing facility may test for, and provide test results for, additional cannabinoids, if requested to do so by the client of the cannabis testing facility; however, these additional tests will not be certified by the CDC.G. When testing for homogeneity of cannabinoids in cannabis products:(1) The cannabis testing facility must perform a homogeneity test for Total THC or Total CBD, whichever is purported by the manufacturer to be the largest ingredient content, for each production batch. If the amounts of Total THC and Total CBD are very similar (near 1:1), the cannabis testing facility must test for homogeneity of Total THC.(2) A homogeneity test requires at least two increments, collected separately from those collected for the field primary sample, from different regions of the production batch, and analyzed as separate samples. Sample collection must be in accordance with procedures in the OCP's best practices guidance document for sampling cannabis for mandatory testing purposes and the cannabis testing facility's standard operating procedure for sampling.(3) The cannabis testing facility must determine the relative standard deviation of Total THC or Total CBD content using test results of the two separately collected increments and the field primary sample collected for potency analysis. If the relative standard deviation is greater than 15%, then the batch "fails" the homogeneity test.H. When testing for homogeneity of edible cannabis products, a minimum size sample of 0.5 grams per increment is required.(1) The number of samples required for analysis is specified in Table 5.5-A. Each increment constitutes one packaged unit.(2) Total THC and, if applicable, Total CBD values between samples must not vary by more than 15% or the product fails testing.I. If a batch fails homogeneity testing, the batch may be remediated and retested.Section 6.7 - Residual Solvents and Processing Chemicals A. The minimum sample size of 0.5 grams of representative sample is required for residual solvent analysis.B. The cannabis testing facility must analyze samples in each production batch for residual solvents and processing chemicals, including but not limited to inherently hazardous substances, in accordance with Table 6.7-A. (1) A licensee is not required to test a cannabis product for residual solvents, poisons and toxins if all cannabis concentrate used to make the cannabis product has previously passed mandatory testing for residual solvents.(2) The cannabis testing facility is not required to analyze for residual solvents and processing chemicals in dried flower, kief and hashish or cannabis products manufactured without chemical solvents.(3) The cannabis testing facility is not required to analyze an orally-consumed tincture cannabis product containing alcohol for residual ethanol.C. For the purposes of residual solvent testing, the cannabis testing facility must report that the sample "passed" residual-solvent testing, if the concentrations of residual solvents are reported at or below the residual solvents and processing chemicals action levels in Table 6.7-A below. cannabisD. The cannabis testing facility must report the solvents and processing chemicals listed in this section, in parts per million (ppm) to three significant figures. The cannabis testing facility must report this information in the certificate of analysis.E. The cannabis testing facility must test both the concentrations of solvents and processing chemicals in the sample within the certificate of analysis, as well as document clearly whether the sample "passed" or "failed" residual solvent and processing-chemicals testing.F. If the sample fails residual solvent testing, the batch may be remediated in accordance with all applicable rules from OCP.G. A remediated batch that previously failed a test due to exceeding the action levels for residual solvents must be retested for solvents. Table 6.7-A. Concentration Limits for Residual Solvents, (mg/kg)
Chemical Name | CAS No. | Cannabis Product (ppm) |
Acetone | 67-64-1 | 5000 |
Acetonitrile | 75-05-8 | 410 |
Butanea | 106-97-8 | 5000 |
Ethanolb | 64-17-5 | 5000 |
Ethyl acetate | 141-78-6 | 5000 |
Ethyl ether | 60-29-7 | 5000 |
Heptane | 142-82-5 | 5000 |
Hexane** | 110-54-3 | 290 |
Isopropyl alcoholb | 67-63-0 | 5000 |
Methanol | 67-56-1 | 3000 |
Pentane | 109-66-0 | 5000 |
Propanea | 74-98-6 | 5000 |
Toluene** | 108-88-3 | 890 |
Total Xylenes (m, p, o-xylenes) ** | 1330-20-7 | 2170 |
1,2-Dichloroethane | 107-06-2 | 1 |
Benzene** | 71-43-2 | 1 |
Chloroform | 67-66-3 | 1 |
Ethylene oxide | 75-21-8 | 1 |
Methylene chloride | 75-09-2 | 1 |
Trichloroethylene | 79-01-6 | 1 |
Any other solvent detected not permitted for use | | None Detected |
** Due to the possible presence in the solvents approved for use, limits have been listed accordingly
Note:
a) USP does not provide residual solvent limits for this solvent, the default USP Class 3 limits for acceptable use solvents was assigned as a limit.
b) Products that are orally consumed and/or topically applied are exempt from ethanol limits.
Section 6.8 - Residual Pesticides and Growth Regulators A. The minimum sample size is 0.5 grams of representative samples for all cannabis and cannabis products. B. The cannabis testing facility must test all cannabis samples for pesticides, fungicides, insecticides and growth regulators to ensure pesticide use and use of plant regulators are in compliance with applicable rules related to pesticides. (1) A licensee is not required to test a cannabis concentrate or a cannabis product for pesticides, fungicides, insecticides and growth regulators if all cannabis flower and/or trim used to make the cannabis concentrate or cannabis product has previously passed mandatory testing for pesticides, fungicides, insecticides and growth regulators.C. The results of pesticide analyses must be less than the limits identified in Table 6.8-A below.D. The cannabis testing facility must report the levels detected in micrograms per kilogram (µg/kg) to three significant figures in the certificate of analysis. If a sample is found to contain pesticides above the cannabis limits listed in Table 6.8-A, the sample "fails" pesticide testing.E. The cannabis testing facility must analyze samples for the pesticides listed in Table 6.8-A below utilizing analytic procedures in accordance with 7 CFR, Part 205 and the Official Methods of Analysis of the AOAC International or other current applicable validated methodologies for determining the presence of contaminants in agricultural products.F. Batches of cannabis or cannabis products that fail testing for pesticides may not be remediated but may be retested in accordance with the requirements of 18-691 CMR, ch. 1. Table 6.8-A. Concentration Limits for Pesticides, Fungicides and Growth Regulators, (mg/kg)
Pesticide | Cannabis Product (ppm) | Pesticide | Cannabis Product (ppm) |
Abamectin | 0.5 | Imazalil | 0.2 |
Acephate | 0.4 | Imidacloprid | 0.4 |
Acequinocyl | 2 | Kresoxim-methyl | 0.4 |
Acetamiprid | 0.2 | Malathion | 0.2 |
Aldicarb | 0.4 | Metalaxyl | 0.2 |
Azoxystrobin | 0.2 | Methiocarb | 0.2 |
Bifenazate | 0.2 | Methomyl | 0.4 |
Bifenthrin | 0.2 | Methyl parathion | 0.2 |
Boscalid | 0.4 | MGK-264 | 0.2 |
Carbaryl | 0.2 | Myclobutanil | 0.2 |
Carbofuran | 0.2 | Naled | 0.5 |
Chlorantraniliprole | 0.2 | Oxamyl | 1 |
Chlorfenapyr | 1 | Paclobutrazol | 0.4 |
Chlorpyrifos | 0.2 | Permethrins 1 | 0.2 |
Clofentezine | 0.2 | Phosmet | 0.2 |
Cyfluthrin | 1 | Piperonylbutoxide | 2 |
Cypermethrin | 1 | Prallethrin | 0.2 |
Daminozide | 1 | Propiconazole | 0.4 |
Diazinon | 0.2 | Propoxur | 0.2 |
DDVP (Dichlorvos) | 1 | Pyrethrins 2 | 1 |
Dimethoate | 0.2 | Pyridaben | 0.2 |
Ethoprophos | 0.2 | Spinosad | 0.2 |
Etofenprox | 0.4 | Spiromesifen | 0.2 |
Etoxazole | 0.2 | Spirotetramat | 0.2 |
Fenoxycarb | 0.2 | Spiroxamine | 0.4 |
Fenpyroximate | 0.4 | Tebuconazole | 0.4 |
Fipronil | 0.4 | Thiacloprid | 0.2 |
Flonicamid | 1 | Thiamethoxam | 0.2 |
Fludioxonil | 0.4 | Trifloxystrobin | 0.2 |
Hexythiazox | 1 | | |
Note:
1. Permethrins are measured as cumulative residue of cis- and trans- permethrin isomers. (CAS numbers 54774-45-7 and 51877-74-8 respectively). 2. Pyrethrins are measured as cumulative residues of Pyrethrin. Cinerin, and Jasmolin (CAS number 8003-34-7).
Section 6.9 - Heavy Metals A. The minimum representative sample size is 0.5 grams of all cannabis and cannabis products.B. When testing for heavy metals, the cannabis testing facility must analyze all samples for concentrations of the heavy metals listed in Table 6.9-A below. (1) A licensee is not required to test a cannabis product for heavy metals if the cannabis concentrate used to make the cannabis product has previously passed mandatory testing for heavy metals.C. The cannabis testing facility must report the concentration of each heavy metal in micrograms per kilogram (µg/kg) in the certificate of analysis.D. The cannabis testing facility must report that the sample "passed" heavy metal testing, if the concentrations of heavy metals listed in the table below are below the following heavy metal action levels.E. The cannabis testing facility may test for and report test results for additional metals, if the instrumentation detects additional metals in the samples, or if requested by the State or the client of the cannabis testing facility testing.F. Batches of cannabis or cannabis products that fail testing for metals may not be remediated but may be retested in accordance with the requirements of 18-691 CMR, ch. 1.G.Table 6.9-A. Concentration Limits for Heavy Metals, (µg/kg)
Heavy Metal | Inhalation (ppb) | Ingestion or Suppository (ppb) | Topical Application (ppb) |
Cadmium (Cd) | 200 | 500 | 5000 |
Lead (Pb) | 500 | 500 | 10,000 |
Arsenic (As) | 200 | 1500 | 1000 |
Mercury (Hg) | 100 | 3000 | 1000 |
These limits apply to cannabis and cannabis concentrate intended for ingestion, inhalation or dermal application, based on inhalation limits described in USP<232> Elemental Impurities-Limits.
Section 6.10 - Microbiological Impurities A. The minimum representative sample size of 2.0 grams of finished plant material is required for analysis. The minimum representative sample size of 1.0 g of cannabis products is required for analysis. The minimum representative sample size of 1.0 g of cannabis concentrate is required for analysis.B. For the purposes of microbiological testing, the cannabis testing facility must report that the sample "passed" microbiological-impurity testing if the contaminants listed in Table 6.10-A below do not exceed the limits. If the cannabis product is found to have a contaminant in levels exceeding those established as permissible under this rule, then it failed microbial testing.C. A licensee may attempt to remediate a batch of finished plant material or cannabis concentrate that fails microbial testing.D. If the licensee chooses to remediate following a failed fungus or mold test, the batch will need to be retested by the same cannabis testing facility and shall include mycotoxin analysis, including Aflatoxins (B1, B2, G1 and G2) and Ochratoxin A. The total combined result of the five required mycotoxins must be less than 20 µg/kg to be considered a passing result. Table 6.10-A. Limits for Microbiological Contaminants in CFU/g
Cannabis Material | Total Viable Aerobic Bacteria | Total Yeast and Mold | Total Coliform Bacteria | Enterobacteriacaea | E. coli (STEC) and Salmonella (spp.) |
Plant Material and Cannabis Products | 105 | 104 | 103 | 103 | <1/g sample |
CO2 and Solvent-Based Concentrates | 104 | 103 | 102 | 102 | <1/g sample |
Based on analytical limits based on American Herbal Pharmacopoeia, Revision 2014.
E. The cannabis testing facility must report the concentration of each mycotoxin in micrograms per kilogram (µg/kg) to three significant figures in the certificate of analysis.F. The cannabis testing facility must report the concentration of total aerobic bacteria, total yeast and mold, total Coliform bacteria and Enterobacteriaceae in CFU/g to two significant figures in the certificate of analysis.G. The cannabis testing facility must report whether the strains listed in Table 6.10-A are detected, or are not detected, in 1.0 gram. The cannabis testing facility must report this information in the certificate of analysis. If any strains are detected above limits set in Table 6.10-A above, the batch fails testing and may not be released for sale.H. The cannabis testing facility may test for and provide test results for additional microorganisms if requested.Section 6.11 - Water Activity A. The minimum representative sample size of 0.5 grams of dried flower and 1.0 g of edible products is required for analysis.B. If the water activity in a dried flower production batch sample is at or below, 0.65 Aw, the sample "passes" water-activity testing.C. If the water activity in solid and semi-solid edible cannabis products that do not require additional preservation (e.g. refrigeration) is at, or below, 0.85 Aw, the sample "passes" water-activity testing.D. The cannabis testing facility must report the water-activity level of the sample in Aw to two significant figures.E. Batches of cannabis or cannabis products that fail testing for water activity may be remediated and/or retested in accordance with the requirements of 18-691 CMR, ch. 1.F. The cannabis testing facility must report this information in the certificate of analysis.G. The cannabis testing facility may provide additional information on water activity results, if the cannabis testing facility determines that it is important, or if it is requested.Section 6.12 - Visual Inspection for Filth and Foreign Material A. The minimum sample size is 0.5 grams of representative samples.B. The cannabis testing facility must visually inspect all samples for signs of filth and foreign material present in the sample. "Filth and foreign material" includes, but is not limited to, hair, insects, feces, packaging contaminants and manufacturing waste and by-products.(1) The samples shall not pass if any living or dead insect, at any life cycle stage; one hair; or one count of mammalian excreta is found.(2) The sample shall not pass if more than one fourth of the total area is covered by mold, sand, soil, cinders, dirt or imbedded foreign material.C. The cannabis testing facility must report in the certificate of analysis whether the sample "passed" or "failed" visual inspection for filth and foreign material.(1) If it fails visual inspection for filth and foreign material, the batch fails testing.(2) A production batch that fails must be destroyed unless it can be remediated pursuant to any rules of OCP.(3) Failed batches not successfully remediated must be destroyed.Section 6.13 - Terpenes A. The cannabis testing facility may also report individual terpene results, as requested.B. If the product labeling reports that the sample contains discrete terpenes, the cannabis testing facility must test for those terpenes. The cannabis testing facility must report to one-hundredth of a percent the concentration in percentage in the certificate of analysis.Section 6.14 - Quality Control A.The cannabis testing facility must use quality control samples in the performance of each assay for chemical and microbiological analyses.(1) The cannabis testing facility must analyze the quality control samples in the exact same manner as the test samples, to validate the testing results.B. The cannabis testing facility must run quality control samples with every analytical batch of samples. For chemical analyses, the cannabis testing facility must prepare and analyze samples in batches of up to 20 samples, to include a method blank, a laboratory control sample, a sample duplicate, a matrix spike sample, and a certified reference material when available.(1) A method blank means an analyte-free matrix, to which all reagents are added in the same volumes or proportions as are used in sample preparation. (a) Method blanks are analyzed under the same conditions, including sample preparation steps, as the other samples in the analytical batch to demonstrate the analytical process does not introduce contamination.(b) If the method blank contains analyte(s) of interest greater than half of the reporting limit or limit of quantitation, but below the limit of quantitation, the data must be flagged with a "B" and an explanation noted in the certificate of analysis.(c) If the method blank contains analyte(s) of interest above the limit of quantitation, it may be reanalyzed once. If the method blank is still above the limit of quantitation, the cannabis testing facility must seek to locate and reduce the source of the contamination, and then the entire batch must be re-prepared and reanalyzed. If the method blank results still do not meet the acceptance criteria, and/or reanalysis is not practical, then the cannabis testing facility must halt performing the analysis until resolution of this issue. Resolution of the issue requires the reduction of method blank measurements below the limit of quantification.(d) In instances where the method blank contains analyte(s) of interest above the limit of quantitation but the samples in the associated batch do not contain any level of those specific analytes, the data for that batch may be reported as flagged as described in (b) above. If any of the samples in the batch contain those analytes at levels above the limit of quantitation, then that data cannot be reported, and the issue must be resolved before running further samples.(2) A laboratory control sample means a simplified sample matrix, free from analytes of interest, spiked with known amounts of analytes, using a second source standard (a standard obtained from a different supplier than the calibration standards), where available, and taken through all sample preparation and analytical steps of the procedure, unless otherwise noted in a reference method (also known as a laboratory fortified blank, spiked blank or quality control check sample). (a) When reference standards are commercially available in usable concentrations, and are applicable to the method being run, the cannabis testing facility must prepare and run one or more matrix samples spiked with the standard at a known concentration for each analytical batch up to 20 samples.(b) The cannabis testing facility must calculate the percent recovery for quantitative chemical analysis, for the laboratory control sample spiked with a known amount of reference standard. The acceptable percent recovery is ±20%.(c) If the percent recovery is outside of the acceptable range, the cannabis testing facility must investigate the cause, correct the problem and re-run the batch of samples, if possible. If the problem persists, the cannabis testing facility must re-prepare the batch of samples and run the analysis again, if possible. If a laboratory control sample is performed and fails, it must be flagged with "*" and an explanation noted in the certificate of analysis.(3) A sample duplicate means a separate aliquot of the sample carried through the complete preparation and analytical procedure.(a) The acceptance criteria between the primary sample and the duplicate sample must be less than 20% relative percent difference. Relative percent difference is calculated using the following equation: RPD = | (primary sample measurement - duplicate sample measurement) | / ([primary sample measurement + duplicate sample measurement] / 2) x - 100%.(b) Limits must be set at <20% until enough data points are established to create lab defined limits. At no point can lab calculated limits be greater than the 20% listed in this rule.(c) If the RPD exceeds the acceptance limits for a sample duplicate, it must be flagged with a "*" and an explanation noted in the certificate of analysis.(4) A matrix spike means a sample prepared by adding a known quantity of analyte and subjecting the sample to the entire analytical procedure to determine the ability to recover the known analyte or compound.(a) When reference standards are commercially available in usable concentrations and are applicable to the method being run, the cannabis testing facility must prepare and run one or more matrix samples spiked with the standard at a known concentration for each analytical batch up to 20 samples. The matrix spike sample must be prepared with all of the target analytes for that analysis with the exception of (b) below and that for residual solvents, the spike must contain all of the target analytes that have a pass/fail concentration limit greater than 1 ppm.(b) For potency analysis, if a commercial reference standard is not available in usable concentrations, a cannabis testing facility may develop an in-house reference material as a spiking standard to be used in that analysis as described in Section 6.13 B(5) (b) below. This spiking standard must contain at least one of the required target analytes for potency analysis.(c) The cannabis testing facility must calculate the percent recovery for quantitative chemical analysis by analyzing an aliquot of sample spiked with a known amount of reference standard. An aliquot of the sample is analyzed without the spike, and the result is subtracted from the spiked value. The sample result, after subtraction, is divided by the expected result and multiplied by 100. If interferences are present in the sample, results may be significantly higher or lower than the actual concentration contained in the sample. The acceptable percent recovery is 70% to 130%.(d) If the percent recovery is outside of the range, the cannabis testing facility must investigate the cause, correct the problem and re-run the batch of samples, if possible. If the problem persists, the cannabis testing facility must re-prepare the samples and run the analysis again, if possible. If a matrix spike is performed and fails, it must be flagged with an "*" and an explanation noted in the certificate of analysis.(5) A certified reference material (CRM) means a reference material, accompanied by a certificate, having a value, measurement of uncertainty and stated metrological traceability chain to a national metrology institute. The CRM must be in a matrix comparable to the samples being analyzed.(a) When commercially available at a reasonable cost, a certified reference material must be obtained from an outside source.(b) If an in-matrix CRM is not available from an outside source, the cannabis testing facility may make its own in-house reference material. In-house reference material must contain verified amounts of analytes determined by analyzing a batch of thoroughly homogenized sample material a minimum of ten times and using the average result of those ten replicate analyses as the accepted verified value.(c) The CRM must fall within the quality control acceptance criteria given in its certificate, criteria given in a referenced test method, or be within +/- 20% of the given value, whichever is most stringent. If an in-house reference material is used, the result must fall within +/-20% of the verified value as determined in (b) above. If the result does not meet these criteria, the cannabis testing facility must investigate the cause, correct the problem and re-run the batch of samples, if possible. If the problem persists, the cannabis testing facility must re-prepare the samples and run the analysis again, if possible. If a CRM or in-house reference material is performed and fails, it must be flagged with an "*" and an explanation must be noted in the certificate of analysis.C. For microbiological analysis, the cannabis testing facility must prepare and analyze a negative control sample and a positive control sample for each new lot of testing media or reagent.(1) A negative control sample means a QC sample for microbiological testing that is expected to produce a reaction which indicates the absence of the target organism.(2) A positive control sample means a QC sample for microbiological testing that is expected to produce a reaction which indicates the presence of the target organism.(3) Positive and negative control samples are analyzed under the same conditions as samples in an analytical batch to demonstrate the analytical process does not adversely affect test results.(4) If the positive or negative control sample results do not meet acceptance criteria, the cannabis testing facility must investigate the cause, correct the problem, and rerun the positive and negative control samples. If the problem persists, the cannabis testing facility must reject the lot of testing media or reagent and use a new lot that passes QC testing.D. The cannabis testing facility must prepare calibration standards by diluting a standard solution to produce working standards used for calibration of the instrument and quantitation of analyses in samples.E. Cannabis testing facility must perform initial calibration of instruments and calibration verification.(1) Initial Calibration a. Sufficient records must be retained to permit reconstruction of the instrument calibration such as calibration date, approved method identification, instrument, analysis date, each analyte name, the manual or electronic identification of the analyst performing the test, concentration and response, calibration curve or response factor or unique equation or coefficient used to reduce instrument responses to concentration.b. Sample results must be quantitated from the most recent instrument calibration and may not be quantitated from any earlier instrument calibration verification.c. All instrument calibrations must be verified with a standard obtained from a second source such as a different manufacturer, when available. Traceability must be to a national standard, when available.d. Criteria for the acceptance of an instrument calibration shall include, at a minimum, a correlation coefficient not less than 0.99. Additional criteria used must be appropriate to the calibration technique employed and must be documented in the laboratory's SOP.e. The following must occur for methods employing standardization with a zero point and a single point calibration standard:(i) Before the analysis of samples, the linear range of the instrument must be established by analyzing a series of standards, one of which must encompass the single point quantitation level;(ii) A zero point and a single point calibration standard must be analyzed with each analytical batch;(iii) A standard corresponding to the RL must be analyzed with each analytical batch and must meet established acceptance criteria;(iv) The linearity must be verified at a frequency established by the method or the manufacturer; and(v) If allowed in the rule, a sample result within an analytical batch, higher than its associated single point standard, can be reported if the following conditions are met: (1) A standard with a concentration at or above the analyte concentration in a sample must be analyzed and must meet established acceptance criteria for validating the linearity;(2) The sample must be diluted such that the result falls below the single point calibration concentration; or(3) The data must be reported with an appropriate data qualifier or an explanation in the narrative of the test report.f. If the instrument calibration results are outside established acceptance criteria, corrective actions must be performed, and all associated samples reanalyzed. If reanalysis of the samples is not possible, data associated with an unacceptable instrument calibration must be appropriately qualified on the test report.g. Calibration standards must include concentrations at or below the limit specified in the rule.h. The minimum number of calibration standards shall be dependent upon the calibration range desired. A minimum of three calibration standards are required to calibrate a range of a factor of 20 in concentration. For a factor of 50, at least four calibration standards are required, and for a factor of 100 or more, a least five calibration standards are required. The calibration standards must contain each analyte of concern at concentrations that define the range of the method. For each calibration range, one of the calibration standards must be at the RL, not including blanks or a zero standard, with the exception of instrument technology for which it has been established by methodologies and procedures that a zero and a single point standard are appropriate for calibrations. The cannabis testing facility must have an SOP that documents the protocol for determining the number of points required for the instrument calibration employed and the acceptance criteria for calibration.i. It is prohibited to remove data points from within a calibration range while still retaining the extreme ends of the calibration range.(2) Calibration verification a. When an instrument calibration is not performed on the day of analysis, the instrument calibration must be verified before analysis of samples by analyzing a calibration standard with each batch.b. Calibration verification must be repeated at the beginning of each batch, after every tenth sample, excluding QC samples, and at the end of each batch.c. Sufficient raw data records must be retained to permit reconstruction of the calibration verification, such as: instrument; analysis date; each analyte name, concentration and response; calibration curve or response factor; or unique equations or coefficients used to convert instrument responses into concentrations. Calibration verification records must explicitly connect the verification data to the instrument calibration.d. Criteria for the acceptance of calibration verifications must be established and evaluated using the same technique used to evaluate the instrument calibration.e. If the calibration verification results obtained are outside established acceptance criteria, corrective actions must be performed. If routine corrective action procedures fail to produce a second consecutive (immediate) calibration verification within acceptance criteria, then the cannabis testing facility must either demonstrate performance after corrective action by performing one successful calibration verification or perform a new instrument calibration. If the cannabis testing facility has not demonstrated acceptable performance after the corrective action, sample analyses must not occur until a new instrument calibration is established and verified. Sample data associated with unacceptable calibration verification may be reported as qualified data under the following special conditions if allowed in rule:(i) When the acceptance criteria for the calibration verification are exceeded high (high bias) and all associated samples contain analytes below the RL, those sample results may be reported.(ii) When the acceptance criteria for the calibration verification are exceeded low (low bias), the sample results may be reported if the concentration exceeds a maximum regulatory limit as defined by the rule.f. When allowed by rule, verification procedures may result in a set of correction factors. If correction factors are employed, the cannabis testing facility must have procedures to ensure that copies of all data records, such as in computer software, are correctly updated.g. Test equipment, including both hardware and software, must be safeguarded from adjustments that would invalidate the test results.F. The cannabis testing facility must store stock standards and reagents per manufacturer's recommendations and use or discard by manufacturer's expiration dates. All prepared standards and reagents must be traceable to stocks, and the date of preparations and expiration date must be traceable in facility documentation.G. If the response for a target analyte exceeds the working range of the calibration curve, the sample extract must be diluted and reanalyzed.H. For chemical analyses, a cannabis testing facility shall utilize an internal standard when possible, and for pesticide analyses, also use surrogate standards as appropriate.I. All quality control measures must be assessed and evaluated on an ongoing basis. QC acceptance criteria in the cannabis testing facility's QA manual must be used to determine the validity of data.J. All instrument method detection and reporting limit studies shall be completed at least annually, and upon a change in methodology.K. If the cannabis testing facility finds evidence that a sample is contaminated due to contamination in the sample collection process, the cannabis testing facility will contact the individual or entity responsible for sample collection to validate the sample collector or self-sampling licensee's decontamination procedure.L. Upon request by the CDC, the cannabis testing facility must in a timely manner generate and submit to CDC a quality control sample report that includes QC parameters and measurements, analysis date and matrix.M. CDC may require in writing reasonable additional quality control measures for any testing methodology as found in previously established Federal or State guidelines such as: (1) AOAC International's Official Methods of Analysis for Contaminant Testing of AOAC International, 21st Edition, 2019;(2) U.S. Food and Drug Administration's NCIMS 2400 Forms, Rev. 04/2019; or(3) State of Maine Comprehensive and Limited Environmental Laboratory Accreditation Rule, 10-144 CMR Ch. 263 (2018).N. CDC and OCP may require a cannabis testing facility to submit to interlaboratory testing at its discretion. 1For production batches of prepackaged cannabis products, one production unit (product packaged for retail sale in either a single or multi-serving package) is one sample increment. For production batches of unpackaged cannabis products, one serving size of the cannabis product is one sample increment.