Rule 42.39.614 - QUALITY ASSURANCE TESTING REQUIREMENTS(1) All marijuana items intended for final sale or transfer to a customer shall be tested in its final form. The addition of any ingredient or reagent after final quality assurance testing will require retesting with respect to the mandatory quality assurance testing requirements provided in the Quality Assurance Testing Requirements Appendix and the marijuana laws. The department adopts and incorporates by reference the Quality Assurance Testing Requirements Appendix (Version 1.0) (August 24, 2024), which provides quality assurance testing requirements from marijuana item classifications and subcategories and details specific contaminant testing requirements for these items. A copy of the Appendix is available from the department electronically at www.mtrevenue.gov/cannabis and may also be obtained at 125 N. Roberts St., Helena, MT 59601.(2) Composite laboratory test samples from the same or different process lots and test batches therein are prohibited.(3) Composite laboratory test samples from the same or different harvest lots and test batches therein are strictly prohibited. Effective February 24, 2025, multi-strain harvest lots and multi-strain composite laboratory test samples are prohibited.(4) Usable marijuana: a licensee shall submit for testing all harvest lots and test batches therein of usable marijuana for the analyses required in Table 1.0a of the Appendix prior to final sale to a customer. Usable marijuana, including trim or manicure, shall also be tested for the analyses provided in Table 1.0a of the Appendix prior to use in the production of marijuana pre-rolls and direct marijuana-infused products. A licensee may forego testing of usable marijuana, including trim and manicure, only if that usable marijuana is subjected to solvent or non-solvent-based extraction for the production of marijuana concentrates and extracts.(5) Solvent-based and non-solvent-based marijuana concentrate and extract: a licensee shall submit for testing all process lots and test batches therein of solvent-based and non-solvent-based marijuana concentrate and extract for the analyses provided in Table 1.0b of the Appendix prior to final sale to a customer and prior to use in the production of marijuana-infused products or marijuana pre-rolls.(6) Marijuana-infused products: a licensee shall submit for testing all process lots and test batches therein of marijuana-infused products for the analyses set forth under Table 1.0c of the Appendix prior to final sale to a customer.(7) Marijuana pre-rolls: If the potency of the marijuana pre-roll process lot in question is expected to change from that of the previously tested and compliant usable marijuana, a licensee shall submit for testing all the process lots and test batches therein of marijuana pre-rolls for the analyses provided in Table 1.0d of the Appendix prior to final sale to a customer. Examples include mixing multiple strains of usable marijuana into a process lot of pre-rolls and all process lots of infused pre-rolls.(8) A licensee shall submit for testing all process lots and test batches therein of marijuana items that consist of two or more previously tested and compliant marijuana items into a final form marijuana item (such as moon rocks or canna-cigars) for potency prior to final sale to customers.(9) Use of any untested marijuana item in the production of marijuana-infused products and marijuana pre-rolls is prohibited. Use of any untested marijuana item, except for usable marijuana - including trim and manicure - in the production of concentrates and extracts is prohibited.(10) The potency test for each sample must include: (f) all other cannabinoids a testing laboratory reports to the client on the certificate of analysis, which shall be entered into the seed-to-sale tracking system.(11) The laboratory test sample and related lot or test batch fail quality assurance testing for moisture analysis if the results are greater than 15.0 percent.(12) 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 percent of stems 3mm or more in diameter; or(b) 2.0 percent of seeds or other foreign matter.(13) 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: non-detectable in 1.0 gram of material;(b) Shiga-toxin producing Escherichia Coli (STEC): non-detectable in 1.0 gram of material; and(c) Pathogenic Aspergillus species A. flavus, A. fumigatus, A. niger, and A. terreus: Each non-detectable in 1.0 gram of material.(14) Microbiological testing using molecular methods must include an enrichment step.(15) The laboratory test sample and related lot fail quality assurance testing for mycotoxins if the results are greater than the following action levels:(a) Total of Aflatoxin B1, B2, G1, G2: 20 µg/kg; and(b) Ochratoxin A: 20 µg/kg.(16) 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 2.0 of the Appendix.(17) Heavy metals shall 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 3.0 of the Appendix.(18) 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 Tables 4.0a and 4.0b of the Appendix, as of their respective effective dates.Mont. Admin. r. 42.39.614
NEW, 2019 MAR p. 1868, Eff. 10/19/2019; AMD, 2022 MAR p. 58, Eff. 1/15/2022; TRANS, from 37.107.316, 2023 MAR p. 570, Eff. 7/2/2023; AMD, 2024 MAR p. 2075, Eff. 8/24/2024AUTH: 16-12-202, 16-12-209, MCA; IMP: 16-12-202, 16-12-209, MCA