§ 5700. Defwitions In addirion to the definitions in section 5000 of this division, the following definitions apply to this chapter. (a) “Acceptance criteria” means the specified limits placed on the. characteristics of an item or method that are used to determine data quality. (b) “Accredited college or university” means a college ar university accredited by a regional or national accrediting agency that is an accreditar recognized by the Secretary of the US Department of Education. (c) “Accreditation body” means an impartial non-profit arganization that operates in conformance with the International Organization for Standardization (ISO) /International Electrotechnical Commission (IEC) standard 17011 and is a signatory to the International Labaratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA) for Testing. (d) “Action level” means the threshold value that provides the. criterion fpr determining whether a sample passes or fails an analytical test. (e) “Analyte” means a chemical, compound, element, bacteria, yeast, fungus, or toxin to be identified or measured. (fl “Analytical batch” means a group of samples that is prepared together for the same analysis. . and analyzed sequentially using the same instrument calibration curve and that have common analytical quality control checks. (g) “Analytical method” means a technique used qualitatively or quantitatively to determine the composition of a sample or a microbial contamination of a sample. (h) “Cannabinoid” means a class of diverse chemical compounds derived from a cannabis plant. (i) “CAS number” means the unique numerical identifier assigned to every chemical substance by Chemical Abstracts Service, a division of the American Chemical Society. (j) “CBD” means cannabidiol, CAS number 13956-29-L (k) “CBDA” means cannabidiolic acid, CAS number 1244-58-2. (1) “CBG” means cannabigerol, CAS number 25654-31-3. (m) “CBN” means cannabinol, CAS number521-35-7. (n) “Certificate of accreditation” means a document issued by an accreditation body that attests to the laboratory’s competence to carry out specific testing analysis.
(o) “Certificate of analysis” means the report prepared by the laboratory about the analytical testing performed and results obtained by the laboratory. (p) “Certified reference materiaP’ means a reference material prepared by a certifying body or a party independent of the laboratory with ISO/IEC 17034 accreditation. (c~ “Continuing calibration verification” means a type of quality control sample that is a midrange calibration standard which checks the continued validity of the initial calibration of the inshument. (r) `Exclusivity” means the specificity of the test method for validating microbial testing methods. Tt evaluates the ability of the method to disringuish the target organisms from similar buY genetically distinct non-target organisms. (s) “Field duplicate sample” means a sample that is taken in the identical manner and from the same cannabis batch being sampled as the primary sample. It is analyzed separately from the primary sample and is used for quality control purposes only. (t) “Foreign material” means any filthy, putrid, or decomposed substance including hair, insects, excreta, or related adulterant that. may be hazardous or cause illness or injury to the consumer. (u) “Frequency” means the number of items occurring in each category. Frequency maybe determined by analytical method ar laboratory specific requirements for accuracy, precision of the analysis, or statistical calculation. (v) “Sample increment” means a portion of a batch that, together with other increments, makes up the sample. (w) “Inclusivity” means, related to microbiological method validation, the sensitivity of the test method. It evaluates the ability of the test method to detect a wide range of target organisms by a defined relatedness, (x) “Inhalable” means consumable in gaseous or vapor form through the lungs. (y) “ISO/IEC” means the joint technical committee of the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). (z) “ISO/IEC 17025” means the general requirements specified by the ISO/IEC for the competence of testing and calibration laboratories. (aa) “ISO/IEC 17034” means the general requirements established by the ISO/TEC for the competence of reference material producers. (bb) “ISO/IEC 17043” means the general requirements established by the ISO/IEC for proficiency testing. (cc) “Laboratory” means “testing laboratory” as defined at Business and Professions Code .section 26001(as).
(dd) “Laboratory replicate sample” means a duplicate sample of the primary sample used for quality control purposes to demonstrate reproducibility. It is prepared in the identical manner as the primary sample and analyzed separately from the primary sample. (ee) “Laboratory quality assurance” means the 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, among other things. (f~ “Limit of detection” means the lowest quantity of a substance or analyte that can be distinguished from the absence of that substance within a stated confidence limit. (gg) “Lunit of guantitarion” means the minimum concentration of an analyte in a specific matrix that can be reliably quantified while also meeting predefined goals for bias and imprecision. (hh) “Matrix”.means the substances fhat are present in a sample except for the analyte(s) of interest. (ii) “Matrix spike duplicate” means the duplicate sample of the matrix spike sample that is prepared by adding a known quantity of a target analyte to a sample matrix or to a matrix that is as closely representative of the matrix being analyzed as possible. (jj) “Matrix spike sample” means a sample prepazed by adding a lrnown quantity of the target analyte to a sample matrix or to a matrix that is as closely representative. ofthe matrix being analyzed as possible. (kk) “Method blank” means an analyte free matrix fo which all reagents are added in the same volumes orproportions as used in the sample preparation. (11) “Moisture content’ means the percentage of water in a sample; by weight. (mm) “Non-target organism” means an organism that the test method or analytical procedure is not testing for and can be used in evaluating the specificity of a test method. (nn) “Percent recovery” means the percentage of a measured concentration relative to the added (spiked) concentration in a reference material, matrix spike sample, or matrix spike duplicaCe. A laboratory shall calculate the percent recovery by dividing the sample result by the expected result then multiplying that the quotient by 100. (oo) “Practical experience” means experience performing scientific analytical tests in a labaratory setting using equipment, instruments, kits, and materials routinely found in a laboratory. Practical experience includes experience in any type of laboratory setting and is not lunited to cannabis-specific laboratories. (pp) “Primary sample” means a sample that is comprised of several increments of either cannabis or cannabis products that are collected from a batch for testing. (qq) “Proficiency tesP’ means an evaluation of a laboratory’s performance against preestablished criteria by means of interlaboratory comparisons of test measurements.
(rr) “Proficiency test sample” means a sample that is prepared by a party independent of the testing laboratory with the ISO/IEC 17043 accreditation, where the concentration and identity of an analyte that is known to the independent party, but is unknown to the testing labaratory and testing laboratory employees. (ss) “Quality control” means the set of measures implemented within an analytical procedure to ensure that the measurement system is operating in a state of statistical control for which errors have been reduced to acceptable levels. (tt) “Quality control sample” means a sample that is produced and used by a laboratory for the purpose of assuring the quality of the data and results. Quality control samples include blank samples, matrix spike samples, field duplicate samples, replicate samples, and reference material samples. (uu) “Reagent” means a compound or mixture added to a system to cause a chemical reaction ar test if a reaction occurs. A reagent may be used to tell whether a specific chemical substance is present by causing a reaction to occur with the chemical substance. (vv) “Reference material” means material containing a known concentration of an analyte of interest that is in solution or in a homogeneous matrix. (ww) “Reference method” means the method by which the performance of an alternate method is measured or evaluated. (xx) “Relative percent difference” means the comparative statistic that is used to calculate precision or random errar. RPD is calculated using the following equation: RPD = ~ (primary sample measurement —duplicate sample~measurement) I / ([primary sample measurement +duplicate sample measurement] / 2) X 100% (yy) “Relative standard deviation” means the standard deviation expressed as a percentage of the means recovery. RSD is calculated using the following equation: RSD = (s / x) X 100%; where s =standard deviation and x =mean (zz) “Representative” means a small quantity of the batch whose characteristics represent, as accurately as possible, the entire batch, thus allowing the results to be generalized. (aaa) “Requester” means the person who submits a request to the laboratory for testing of catmabis or cannabis product from an entity licensed under this division. (bbb) “Sample” means a representative part of, or a single item from, a batch which is comprised of several sample increments. (ccc) “Sampler” means the laboratory employee responsible for obtaining samples of cazmabis or cannabis product from a distributor. (ddd) “Sanitize” means to sterilize, disinfect, or make hygienic.
(eee) “Scope of accreditation” means the tests or types of tests per#~ormed, materials or producTs tested, and the methods used for testing cannabis or cannabis products for which the accreditarion has been granted. (fffl “Tamper-evident’ means aone-time-use security tape or seal that is affixed to the opening of a package, allowing a person to recognize whether the package has been opened. (ggg) “Target organism” means an organism that is being tested for in an analytical procedure or test method. (hhh) “THC” and “delta-9 THC” means tetrahydrocannabinol, CAS number 1972-08-3. (iii) “THCA” means tetrahydrocannabinolic acid, CAS number 23978-85-0. (jjj) “Validation” means the confirmation by examination and objective evidence that the requirements for a specific intended use or analytical method aze fulfilled. (kkk) “Water activity” means the measure of the quantify of water in a product that is available and therefore capable of supporting bacteria, yeasts, and fungi and which is reported in units Aw.
Proposed Regs. October 19, 2018
§ 5700. Definitions
The numbering of the section has been modified to allow for the inclusion of additional definitions. The definitions for the terms “accreditation body” and “accredited college or university” have been reordered in order to properly place the terms in alphabetical order.
A definition of “cannabis concentrate” has been added to the section and defines a cannabis concentrate as cannabis that has undergone a process to concentrate one or more active cannabinoids, thereby increasing the product’s potency. The definition clarifies that cannabis concentrates includes the following items: the separated resinous trichomes of cannabis, tinctures, capsules, suppositories, extracts, vape cartridges, inhaled products (such as dab, shatter, and wax), and tablets as defined by the State Department of Public Health in regulation. This is necessary to clarify what a cannabis concentrate is, and to align with the term as it is used by other licensing authorities and in regulations.
The definition of “continuing calibration verification” has been revised to further clarify that a licensed testing laboratory must be able to test for each required analyte.
A definition of “good laboratory practice” has been added to the section and defines good laboratory practice as being a quality system of management controls for laboratories to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of analyses performed by the testing laboratory. This definition is necessary because the term is used in the regulations to ensure that laboratories are operating in accordance with general laboratory standards.
The definition of “initial calibration verification” has been amended to remove “targeted” and replace it with “each of the targeted” for clarity. This is necessary to ensure that licensees understand that each analyte must be included.
The definition of “laboratory control sample” has been amended to clarify that spiked concentration must be at a mid-range concentration of the calibration curve for the target analytes. This change is necessary to ensure accuracy in testing procedures.
A definition of “linear regression” has been added to the section and defines linear regression as the determination, in analytical chemistry, of the best linear equation for calibration data to generate a calibration curve. The concentrate of an analyte in a sample can then be determined by comparing a measurement of the unknown to the calibration curve. A linear regression uses the following equation: y = mx + b, where m =slope and b=intercept. This definition is necessary because the term is used in the regulations and ensures laboratories analyze cannabis goods samples using accurate calibration data.
The definition of “matrix spike sample” has been revised to provide additional clarity. This is necessary to ensure standardization in the licensees’ quality control procedures.
A definition for “orally-consumed product containing alcohol” has been added. This addition is necessary to clarify that an “orally-consumed product containing alcohol” means a liquid solution that contains more than 0.5% alcohol by volume as an ingredient, is not otherwise an alcoholic beverage as defined in Business and Professions Code section 23004, is packaged in a container no larger than two (2) fluid ounces and includes a capped calibrated dropper capable of accurately measuring servings. This definition is necessary to align with regulations promulgated by the State Department of Public Health which allows for certain products to contain alcohol as an ingredient. Without this definition testing laboratories would not be able to determine which cannabis products are exempt from the ethanol limit for residual solvent testing under proposed section 5718.
A definition for “orally-dissolving product” has been added. This is necessary to clarify that the term “orally-dissolving product” as used in the regulations means an edible cannabis product that is intended to dissolve and release cannabinoids directly into the mouth, which allows them to enter the bloodstream through the tissue, such as sublingual lozenges or mouth strips. The definition further clarifies that orally dissolving products are not intended to be eaten or swallowed to enter the digestive system. This definition is also necessary to ensure consistency between regulations adopted by the Bureau and the State Department of Public Health.
A definition for pre-roll has been added to specify that for purposes of this chapter, pre-roll has the same meaning as in section 5000(q) and also includes pre-rolls infused with cannabis concentrate. This is necessary to ensure testing laboratories have accurate guidance to identify the type of cannabis goods being tested.
A definition for “quadratic regression” has been added to the section and defines quadratic regression as means the determination, in analytical chemistry, of the best parabola equation for calibration data to generate a calibration curve. The concentrate of an analyte in a sample can then be determined by comparing a measurement of the unknown to the calibration curve. A quadratic regression uses the following equation: y = ax2 + bx + c, where a, b, and c are numerical coefficients. This definition is necessary because the term is used in the regulations and ensures laboratories analyze cannabis goods samples using accurate calibration data.
The definition of “relative percent difference” has been amended to provide an abbreviation for the term defined, RPD, to allow for subsequent use of the abbreviated term in the regulations.
The definition of “relative standard deviation” to provide an abbreviation for the term defined, RSD, to allow for subsequent use of the abbreviated term in the regulations.
The definition of “representative sample” to clarify and specify what a “representative sample” comprises of, which is several sample increments of cannabis goods that are collected from a batch for testing.
The definition of “requester” has been amended to clarify and specify the requirement referenced in this subsection is a requirement under MAUCRSA, not under the proposed regulations.
The definition of “sampler” has been amended to clarify that a licensed microbusiness authorized to engage in distribution, not just any microbusiness, is included. This is necessary for clarity and consistency throughout the regulations.
A definition for “topical cannabis goods” has been added. This is necessary to clarify that the term “topical cannabis goods” means cannabis products intended to be applied to the skin and not intended to be ingested or inhaled. Liquid solutions shall only be considered topical cannabis goods if they are packaged in a container no larger than two (2) fluid ounces.
A definition for “total CBD” has been added and defines total CBD as the molar sum of CBD and CBDA. Total CBD is calculated using the following equation in which “M” is the mass or mass fraction of CBD and CBDA: M total CBD = M CBD + (0.877 x M CBDA). This definition is necessary so that laboratories have the correct formula to calculate total CBD.
A definition for “total THC” has been added and defines total THC as the molar sum of THC and THCA. Total THC is calculated using the following equation in which “M” is the mass or mass fraction of delta-9 THC or delta-9 THCA: M total delta-9 THC = M delta-9 THC + (0.877 x M delta-9 THCA). This definition is necessary so that laboratories have the correct formula to calculate total THC.