ARM 42.39.614

ARM 42.39.614. TESTING LABORATORY QUALITY ASSURANCE TESTING REQUIREMENTS

SupersededLast amended: 2023Length: 950 wordsOfficial source

Cite as Mont. Admin. R. 42.39.614

(1) Except as provided in (10), a licensee must submit for testing a sample of every test batch from a harvest lot of marijuana and process lots of marijuana-infused products, extracts, and concentrates intended for use by a customer prior to selling or transferring the marijuana item to a customer. (2) All marijuana items intended for direct sale or transfer to customers shall be tested in its final form. The addition of any ingredient after final quality assurance compliance testing will require retesting. (3) The cannabinoid profile/potency for each sample must include: (a) THCA; (b) THC; (c) Total potential psychoactive THC for marijuana items that require the application of heat for administration/consumption only; (d) CBDA; and (e) CBD. (4) The laboratory test sample and related lot or test batch fail quality assurance testing for moisture analysis if the results are greater than 12.0%. (5) The laboratory test sample and related lot or test batch fail quality assurance testing for filth and foreign matter screening if the results are greater than the following action levels: (a) 5.0% of stems 3mm or more in diameter; and (b) 2.0% of seeds or other foreign matter. (6) The laboratory test sample and related lot or test batch fail quality assurance testing for microbiological screening if the results are greater than the following action levels: (a) Salmonella species: non-detectable in 1.0 gram of material; (b) Shiga-toxin producing Escherichia coli (STEC): non-detectable in 1.0 gram of material; an d (c) Pathogenic Aspergillus species A. flavus, A. fumigatus, A. niger, and A. terreus : Each non-detectable in 1.0 gram of material. (7) Microbiological testing using molecular methods must include an enrichment step that follows the protocol provided by the manufacturer, molecular method used, or product instructions for use. Decreasing the enrichment time outside of the range provided above is strictly prohibited. (8) The laboratory test sample and related lot fail quality assurance testing for mycotoxins if the results are greater than the following action level: (a) Total of Aflatoxin B1, B2, G1, G2: 20 µg/kg; and (b) Ochratoxin A: 20 µg/kg of substance. (9) A laboratory test sample and related lot or test batch fail quality assurance testing for residual solvents if the results are greater than the action levels provided in table 1.0. Table 1.0 Residual Solvents (CAS) Registry Number Action Level ppm Acetone 67-64-1 5,000 Benzene 71-43-2 2 Total Butanes See 1 5,000 * n-butane 106-97-8 * iso-butane 75-28-5 Chloroform 67-66-3 2 Cyclohexane 110-82-7 3,880 Dichloromethane 75-09-2 600 Ethyl acetate 141-78-6 5,000 Heptane 142-82-5 5,000 Total Hexanes See 2 290 * n-hexane 110-54-3 * 2-methylpentane 107-83-5 * 3-methylpentane 96-14-0 * 2,2-dimethylbutane 75-83-2 * 2,3-dimethylbutane 79-29-8 Isopropanol (2-propanol) 67-63-0 5,000 Methanol 67-56-1 3,000 Total Pentanes See 3 5,000 * n-pentane 109-66-0 * iso-pentane 78-78-4 * neo-pentane 463-82-1 Propane 74-98-6 5,000 Toluene 108-88-3 890 Total Xylenes See 4 2,170 * 1,2-dimethylbenzene 95-47-6 * 1,3-dimethylbenzene 108-38-3 * 1,4-dimethylbenzene 106-42-3 1 Total butanes should be calculated as sum of n-butane and iso-butane. 2 Total hexanes should be calculated as sum of n-hexane, 2-methylpentane, 3-methylpentane, 2,2-dimethylbutane and 2,3-dimethylbutane. 3 Total pentanes should be calculated as sum of n-pentane, iso-pentane, and neo-pentane. 4 Total xylenes should be calculated as sum of 1,2-dimethylbenzene, 1,3-dimethylbenzene, and 1,4-dimethylbenzene. (10) Heavy metals will be tested at random. A laboratory test sample and related lot or test batch fail quality assurance testing for heavy metals if the results are greater than the action levels provided in table 2.0. Table 2.0 Heavy Metals Action Level ppm; Inhalable Marijuana Items Action Level ppm; Other Marijuana Items Inorganic Arsenic 0.2 1.5 Cadmium 0.2 0.5 Lead 0.5 0.5 Mercury 0.1 3.0 (11) A laboratory test sample and related lot or test batch fail quality assurance testing for pesticides if the results are greater than the action levels provided in table 3.0. Table 3.0 Pesticides (CAS) Registry Number Action Level ppm; Dry Flower Action Level ppm; Concentrates and Extracts Abamectin 71751-41-2 0.5 2.5 Acequinocyl 57960-19-7 2 10 Bifenazate 149877-41-8 0.2 1 Bifenthrin 82657-04-3 0.2 1 Chlormequat Chloride 999-81-5 1 5 Cyfluthrin 68359-37-5 1 5 Daminozide 1596-84-5 1 5 Etoxazole 153233-91-1 0.2 1 Fenoxycarb 72490-01-8 0.2 1 Imazalil 35554-44-0 0.2 1 Imidacloprid 138261-41-3 0.4 2 Myclobutanil 88671-89-0 0.2 0.6 Paclobutrazol 76738-62-0 0.4 2 Pyrethrins† 8003-34-7 1 5 Spinosad 168316-95-8 0.2 1 Spirotetramat 203313-25-1 0.2 1 Trifloxystrobin 141517-21-7 0.2 1 † Pyrethrins should be measured as the cumulative residues of pyrethrin 1, cinerin 1, and jasmolin 1 (CAS numbers 121-21-1, 25402-06-6, and 4466-14-2 respectively). (12) Licensees must adhere to testing requirements for all marijuana and marijuana products intended for sale or transfer to customers. (a) Usable marijuana, including trim and manicure must be tested for: (i) pesticides; (ii) moisture content; (iii) cannabinoid profile/potency; (iv) microbiological; (v) mycotoxin; (vi) filth and foreign matter; and (vii) heavy metals (random testing). (b) A licensee has the option to forgo testing of usable marijuana, including trim and manicure, if that usable marijuana is subject to further processing before sale or transfer to customers. (c) Marijuana extract and concentrate that is intended for direct sale or transfer to customers must be tested for: (i) pesticides; (ii) cannabinoid profile/potency; (iii) microbiological; (iv) mycotoxin; (v) heavy metals (random testing); and (vi) residual solvents. (d) Marijuana extract and concentrate that is intended for further processing before direct sale or transfer to customers must be tested for: (i) pesticides; (ii) residual solvents; (iii) mycotoxin; and (iv) heavy metals (random testing). (e) Marijuana infused products intended for human consumption, ingestion, or used as suppositories, topicals, and transdermal patches must be tested for: (i) cannabinoid profile/potency; and (ii) microbiological. (f) All marijuana products listed in (e) must use marijuana extract and concentrate that has passed quality assurance testing requirements as set forth in (d).
ARM 42.39.614: ARM 42.39.614. TESTING LABORATORY QUALITY ASSURANCE TESTING REQUIREMENTS | Justis AI