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Rule Title: DEFINITIONS
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Department: PUBLIC HEALTH AND HUMAN SERVICES
Chapter: MARIJUANA REGISTRY
Subchapter: Testing Laboratories
 
Latest version of the adopted rule presented in Administrative Rules of Montana (ARM):

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37.107.303    DEFINITIONS

As used in this subchapter, the following definitions apply:

(1) "Acceptance criteria" means the specified limits placed on the characteristics of an item or method that are used to determine data quality.

(2) "Accredited college or university" means a college or university accredited by a regional or national accrediting agency that is an accreditor recognized by the Secretary of the U.S. Department of Education.

(3) "Action level" means the threshold value that provides the criteria for determining whether a sample passes or fails an analytical test.

(4) "Adulteration" means intentionally modifying or altering a marijuana item from its original form to increase its monetary value, evade undesirable test results, or conceal the true composition of a marijuana item.

(5) "Analytical batch" means a set of matrix-specific laboratory test samples that are prepared together over a 24-hour time period using the same set of reagents for the same analysis and includes the required quality control samples.

(6) "Applicant" means a person seeking endorsement for testing laboratory licensure or renewal of licensure.

(7) "Batch" has the meaning provided for in ARM 42.39.102.

(8) "CBD" has the meaning provided for in ARM 42.39.102.

(9) "CBDA" has the meaning provided for in ARM 42.39.102.

(10) "Certificate of analysis (COA)" has the meaning provided for in ARM 42.39.102.

(11) "Coefficient of determination (r²)" means a statistical measure that determines how well the regression approximates the actual data points in the calibration curve, with a regression of 1 being a perfect fit.

(12) "Continuing calibration verification (CCV)" means a quality control sample that includes each of the target analytes at the mid-range of the calibration to evaluate the validity of the instrument's calibration over the entire sample sequence. 

(13) "Corrective action" means an action taken by a licensee to resolve, and prevent from recurrence, a problem with operations of the licensee.

(14) "Customer" has the meaning provided for in ARM 42.39.102.

(15) "Harvest lot" means a specifically identified quantity of marijuana that is cultivated utilizing the same growing practices, harvested within a 72-hour period at the same location, and cured under uniform conditions. A harvest lot may contain multiple strains.

(16) "Ingredient" has the meaning provided for in ARM 42.39.102.

(17) "Initial calibration verification (ICV)" means a quality control sample that includes each of the target analytes at the mid-range of the calibration using secondary source standards to evaluate the validity of the calibration standards and calibration standards preparation.

(18) "ISO" means International Organization for Standardization.

(19) "ISO/IEC 17025" means the general requirements specified by the ISO/IEC for the competence of testing and calibration laboratories.

(20) "ISO/IEC 17043" means the general requirements established by the ISO/IEC for proficiency testing.

(21) "Laboratory control sample (LCS)" means a quality control sample that includes each of the target analytes at the mid-range of the calibration spiked into an analyte free matching matrix or a matrix that is as closely representative of the matrix being analyzed as possible, in order to evaluate the efficiency of the preparatory/extraction process. The LCS is prepared in the same manner as the rest of the laboratory test samples in the analytical batch. An LCS is required for contaminant testing only.

(22) "Laboratory quality assurance" means a set of operating principles that enable laboratories to produce defensible data of known accuracy and precision and includes employee training, equipment preventative maintenance procedures, calibration procedures, and quality control testing.

(23) "Laboratory test sample" means all sample increments collected from one test batch combined together into one sample container from which quality assurance compliance testing is conducted.

(24) "Limit of detection (LOD)" means the lowest quantity of a substance or analyte that can be distinguished from the absence of the substance within a stated confidence limit.

(25) "Limit of quantitation (LOQ)" means the lowest concentration of an analyte in the specific matrix that can be reliably quantified while also meeting predefined goals for bias and imprecision.

(26) "Marijuana" has the meaning provided for under 16-12-102, MCA, and ARM 42.39.102.

(27) "Marijuana concentrate and extract" or "concentrate and extract" has the meaning provided for under 16-12-102, MCA, and ARM 42.39.102.

(28) "Marijuana infused products" has the meaning provided for under 16-12-102, MCA, and ARM 42.39.102.

(29) "Marijuana items" has the meaning provided for under ARM 42.39.102.

(30) "Matrix" means the substances that are present in a sample except for the analytes of interest.

(31) "Matrix spike (MS)" means a quality control sample that is prepared by adding a known concentration of target analytes to a laboratory test sample spiked at a mid-range concentration of the calibration to evaluate matrix interference effects. The MS is prepared in the same manner as the rest of the laboratory test samples in the analytical batch.

(32) "Method blank (MB)" means a quality control sample that is prepared using an analyte free matching matrix or a matrix that is as closely representative of the matrix being analyzed as possible to verify the absence of contamination in the preparatory/extraction process. The MB is prepared in the same manner as the rest of the laboratory test samples in the analytical batch.

(33) "Method detection limit (MDL)" means a minimum concentration of a substance that can be measured and reported with 99% confidence that the analyte concentration is greater than zero as determined from analysis of a sample containing the analyte in a given matrix. 

(34) "Method reporting limit (MRL)" means the lowest amount of an analyte in a sample that can be quantitatively determined with stated, acceptable precision and accuracy under stated analytical conditions.

(35) "Preventative action" means a proactive action implemented to eliminate the cause of a potential nonconformance or other quality problem before it occurs.

(36) "Process lot" means:

(a)  any amount of marijuana concentrate or extract of the same type and processed in the same 48-hour period, using the same extraction methods, standard operating procedures, and test batches from the same or different harvest lots; or

(b)  any amount of marijuana products of the same type and processed in the same 48-hour period, using the same ingredients, standard operating procedures, and test batches from the same or different harvest lots or process lots of marijuana concentrate or extract.

(37) "Proficiency test" means an evaluation of a testing laboratory's performance against pre-established criteria by means of interlaboratory comparisons of test measurements.

(38) "Property owner permission form" has the meaning provided for under ARM 42.39.102.

(39) "Quality control sample" means a sample that is produced and used by a testing laboratory for the purpose of ensuring the quality of the data and results. Quality control samples include initial calibration verifications, continuing calibration verifications, laboratory control samples, method blanks, replicates, and matrix spikes. When quality control samples fail it is assumed the preparatory/extraction process, instrumentation, procedures, equipment, etc., are out of statistical control.

(40)  "Raw data" means any testing laboratory worksheet, records, memorandum, notes, or exact copies thereof, that are the result of original observations and activities of testing laboratory study and are necessary for the reconstruction and evaluation of the report of that study. 

(41) "Replicate (REP)" means a quality control sample that is a sub-sample of a laboratory test sample used to evaluate the reproducibility of the preparatory/extraction process. The REP is prepared in the same manner as the rest of the laboratory test samples in the analytical batch.

(42) "Sample increment" means an individual portion of material collected from a test batch.

(43) "Sample integrity" means maintaining marijuana items in a manner that prevents the degradation of testing laboratory results over time between the harvest/process lot, test batch, laboratory test sample, and customer product. Sample integrity factors include consistent storage, temperatures, humidity, and light exposure along with proper handling, transport, and tampering prevention.

(44) "Secondary source standard" means chemical standards sourced from a different supplier or from a different lot number of the same supplier.

(45)  "Seed-to-sale tracking system" has the meaning provided for under ARM 42.39.102.

(46) "Standard operating procedure (SOP)" means a written document that provides detailed instructions for the performance of all aspects of an analysis, operation, or action.

(47) "Test batch" has the meaning provided for under ARM 42.39.102.

(48) "THC" has the meaning provided for under ARM 42.39.102.

(49) "THCA" has the meaning provided for under ARM 42.39.102.

(50)  "Total potential psychoactive THC" has the meaning provided for under ARM 42.39.102.

(51) "Total THC" means the sum of THC and THCa calculated using the following equation:

(a) Total THC =(THCa x 0.877)+THC.

(52) "Validation" means the confirmation, by examination and objective evidence, that the requirements for an analytical method are fulfilled.


History: 16-12-202, 16-12-209, MCA; IMP, 16-12-202, 16-12-209, MCA; NEW, 2021 MAR p. 1059, Eff. 8/28/21; AMD, 2022 MAR p. 58, Eff. 1/15/22.


 

 
MAR Notices Effective From Effective To History Notes
37-967 1/15/2022 Current History: 16-12-202, 16-12-209, MCA; IMP, 16-12-202, 16-12-209, MCA; NEW, 2021 MAR p. 1059, Eff. 8/28/21; AMD, 2022 MAR p. 58, Eff. 1/15/22.
37-950 8/28/2021 1/15/2022 History: 50-46-344, MCA; IMP, 50-46-303, 50-46-307, 50-46-308, 50-46-310, 50-46-318, 50-46-344, MCA; NEW, 2021 MAR p. 1059, Eff. 8/28/21.
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