Rule 42.39.610 - QUALITY ASSURANCE SAMPLING PROTOCOL(1) A testing laboratory must collect samples of marijuana items from licensees for the required quality assurance testing.(2) A testing laboratory must develop and implement a sampling SOP that details at minimum: (a) the testing laboratory's method for obtaining a random and representative sample for all matrices;(b) sterile sampling technique for all matrices;(c) testing laboratory sampler training;(d) appropriate sampling equipment;(e) appropriate sample transportation and storage;(f) maintenance of sample custody and integrity; and(g) sampling documentation and records.(3) Testing laboratories must create a sampling report form for each sampling event, as required by SOP-001. (a) the licensee's business/trade name and licensee ID number;(b) the physical address from which the laboratory test samples are to be collected;(c) the testing laboratory sampler's badge ID number;(d) the testing laboratory vehicle and license plate number; and(e) the date and time the sampling route begins and ends.(4) The testing laboratory shall ensure sample integrity is maintained during transport to and storage at the testing laboratory licensed facilities. If the marijuana item specifies on the label how the product shall be stored, the testing laboratory shall store the sample as indicated.(5) An employee from the licensee requesting sample collection shall be present to observe sample collection but shall not assist the testing laboratory sampler while they are physically collecting the laboratory test samples.(6) The testing laboratory sampler shall collect a laboratory test sample that is random and representative of the test batch, meets the standards of SOP-001, and is sufficient to complete all required quality assurance testing including quality control samples and re-runs.(7) All sample increments from the same test batch shall be placed into one sample container that is free of the analytes of interest and appropriate for the analysis required.(8) At least 50 percent of the laboratory test sample must be homogenized prior to its use for the appropriate analysis.(9) Testing laboratories must refuse sample collection if sample adulteration is suspected and shall report incidents of suspected adulteration to the department within three business days. Adulteration may include: (a) the application of kief to usable marijuana test batches;(b) the application of solvents to usable marijuana test batches;(c) the use of any deleterious substance to evade undesirable test results;(d) the addition of any substance to increase any cannabinoid test result; or(e) the addition of any substance to alter the weight of a marijuana item.(10) A licensee shall only order tests for marijuana items that the licensee has grown, produced, processed, or legally purchased from another licensee.(11) The licensee shall store and secure test batches in a manner that maintains sample integrity and security during laboratory testing.(12) Failed or remediated marijuana items shall be re-tested at the same testing laboratory from which the original failed test results came unless explicit written permission from the department is granted prior to re-testing.(13) The department may inspect marijuana sampling events to ensure sampling protocols are being followed.(14) The department adopts and incorporates by reference the "Quality Assurance Sampling Protocol for Usable Marijuana, Marijuana Concentrates and Extracts, Marijuana-Infused Products, and Marijuana Pre-Rolls" SOP-001 (Version 3.0) (August 24, 2024), which describes the sampling protocol for marijuana, marijuana concentrates and extracts, marijuana-infused products, and marijuana pre-rolls. A copy of SOP-001 is available from the department electronically at www.mtrevenue.gov/cannabis and may also be obtained at 125 N. Roberts St., Helena, MT 59601.Mont. Admin. r. 42.39.610
NEW, 2022 MAR p. 58, Eff. 1/15/2022; TRANS, from 37.107.310, 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