Administrative Rules of Montana › Department 42 - REVENUE › Chapter 42.39 - CANNABIS CONTROL › Subchapter 42.39.6 - Testing Laboratories › Rule 42.39.601 - DEFINITIONS

Current through Register Vol. 13, July 5, 2024
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.