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37.107.310    QUALITY ASSURANCE SAMPLING PROTOCOL

(1) Testing laboratories shall collect samples of marijuana items from licensees for the required quality assurance testing. 

(2) Testing laboratories shall develop and implement a sampling protocol standard operating procedure 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 shall create a sampling plan for each sampling event that details at a minimum:

(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 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 the state laboratory's "Quality Assurance Sampling Protocol for Usable Marijuana, Marijuana Concentrates and Extracts, and Marijuana Infused Products" 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% 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 state laboratory 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 state laboratory is granted prior to re-testing.

(13) The state laboratory may inspect marijuana sampling events to ensure sampling protocols are being followed.

(14) The state laboratory adopts and incorporates by reference the "Quality Assurance Sampling Protocol for Usable Marijuana, Marijuana Concentrates and Extracts, and Marijuana Infused Products" SOP-001 (Version 1.0), which describes the sampling protocol for marijuana, marijuana concentrates and extracts, and marijuana infused products. A copy of this publication is available electronically at https://dphhs.mt.gov/assets/MarijuanaLab/MarijuanaSamplingProtocolSOP.pdf and may also be obtained from the Department of Public Health and Human Services, Laboratory Services Bureau, 1400 E. Broadway, Helena MT, 59620.

 

History: 16-12-202, 16-12-209, MCA; IMP, 16-12-202, 16-12-209, MCA; NEW, 2022 MAR p. 58, Eff. 1/15/22.

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