California Code of Regulations › Title 4 - Business Regulations › Division 19 - Department of Cannabis Control › Chapter 6 - Testing Laboratories › Article 1 - Chapter Definitions › Section 15700 - Definitions

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
In addition to the definitions in section
					 15000, 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) "Accreditation body" means an impartial
				  non-profit organization that operates in conformance with the International
				  Organization for Standardization (ISO) / International Electrotechnical
				  Commission (IEC) standard 17011 and is a signatory to the International
				  Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement
				  (MRA) for Testing.
(c) "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 US Department of Education.
(d) "Action level" means the threshold value
				  that provides the criterion for 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.
(f)
				  "Analytical batch" means a set of no more than 20 samples that is prepared
				  together for the same analysis and are prepared with laboratory quality control
				  (LQC) samples.
(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) "Analytical sequence" means a group of
				  samples that are analyzed sequentially using the same instrument calibration
				  curve.
(i) "Cannabinoid" means a
				  class of diverse chemical compounds derived from a cannabis plant.
(j) "CAS number" means the unique numerical
				  identifier assigned to every chemical substance by Chemical Abstracts Service,
				  a division of the American Chemical Society.
(k) "CBDA" means cannabidiolic acid, CAS
				  number 1244-58-2.
(l) "CBG" means
				  cannabigerol, CAS number 25654-31-3.
(m) "CBN" means cannabinol, CAS number
				  521-35-7.
(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) "Certified reference material" means a
				  reference material in cannabis or similar non-cannabis matrix prepared at a
				  known concentration by a certifying body or a party independent of the
				  laboratory with ISO/IEC 17034 accreditation. The laboratory will calculate the
				  percent recovery of the certified reference material based on measured
				  concentration relative to the known concentration.
(p) "Chain of Custody" (COC) means the
				  chronological documentation that records the sequence of custody, control,
				  transfer, analysis, and disposal of a sample.
(q) "Coefficient of Determination" (commonly
				  denoted as "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.
(r) "Continuing calibration verification"
				  (CCV) means a type of quality control sample that includes each of the target
				  method analytes that is a mid-range calibration standard which checks the
				  continued validity of the initial calibration of the instrument.
(s) "Corrective action" means an action taken
				  by the laboratory to resolve, and prevent from recurrence, a problem with the
				  technical operations of the laboratory.
(t) "Exclusivity" means the specificity of
				  the test method for validating microbial testing methods. It evaluates the
				  ability of the method to distinguish the target organisms from similar but
				  genetically distinct non-target organisms.
(u) "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.
(v) "Frequency" means the
				  number of items occurring in each category. Frequency may be determined by
				  analytical method or laboratory specific requirements for accuracy, precision
				  of the analysis, or statistical calculation.
(w) "Good laboratory practice" (GLP) means a
				  system of management controls for laboratories to ensure the uniformity,
				  consistency, reliability, reproducibility, quality, and integrity of analyses
				  performed by the testing laboratory.
(x) "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.
(y) "Inhalable" means consumable through the
				  lungs.
(z) "Initial Calibration
				  Verification" (ICV) means a solution of each of the target method analytes of
				  known concentration that is obtained from a source external to the laboratory
				  and different from the source of calibration standards.
(aa) "ISO/IEC" means the joint technical
				  committee of the International Organization for Standardization (ISO) and the
				  International Electrotechnical Commission (IEC).
(bb) "ISO/IEC 17025" means the general
				  requirements specified by the ISO/IEC for the competence of testing and
				  calibration laboratories.
(cc)
				  "ISO/IEC 17034" means the general requirements established by the ISO/IEC for
				  the competence of reference material producers.
(dd) "ISO/IEC 17043" means the general
				  requirements established by the ISO/IEC for proficiency testing.
(ee) "Laboratory" means "testing laboratory"
				  as defined at Business and Professions Code section
				  26001(av).
(ff) "Laboratory Control Sample" (LCS) means
				  a blank matrix to which known concentrations of each of the target method
				  analytes are added. The spiked concentration must be at a mid-range
				  concentration of the calibration curve for the target analytes. The LCS is
				  analyzed in the same manner as the representative sample.
(gg) "Laboratory replicate sample" means a
				  sub-sample taken of the representative sample used for laboratory quality
				  control purposes to demonstrate reproducibility. It is prepared and analyzed in
				  the identical manner as the representative sample. The results from replicate
				  analyses are used to evaluate analytical precision.
(hh) "Laboratory employee" means any person
				  directly employed by the laboratory for wages, salary, barter, or trade by the
				  laboratory and who is not employed by any other licensee under the Act except
				  for another testing laboratory. "Laboratory employee" does not mean an
				  independent contractor, third party entity, or any other entity acting on
				  behalf of the laboratory.
(ii)
				  "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.
(jj) "Limit of detection"
				  (LOD) means the lowest quantity of a substance or analyte that can be
				  distinguished from the absence of that substance within a stated confidence
				  limit.
(kk) "Limit of quantitation"
				  (LOQ) 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.
(ll) "Linear
				  regression" means 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, b = intercept
(mm) "Matrix" means the substances that are
				  present in a sample except for the analyte(s) of interest.
(nn) "Matrix spike sample" means a sample
				  prepared by adding a known quantity of each of the target analyte to a sample
				  matrix or to a matrix that is as closely representative of the matrix being
				  analyzed as possible. The spiked concentration must be at a mid-range
				  concentration of the calibration curve for the target analytes.
(oo) "Method Blank" means an analyte free
				  matrix to which all reagents are added in the same volumes or proportions as
				  used in the sample preparation and is processed in exactly the same manner as
				  the samples.
(pp) "Moisture
				  content" means the percentage of water in a sample, by weight.
(qq) "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.
(rr) "Percent recovery" means the percentage
				  of a measured concentration relative to the added (spiked) concentration in a
				  reference material or matrix spike sample. A laboratory shall calculate the
				  percent recovery by dividing the sample result by the expected result then
				  multiplying the quotient by 100.
(ss) "Practical experience" means experience
				  performing scientific analytical tests in a laboratory 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
				  limited to cannabis-specific laboratories.
(tt) "Proficiency test" means an evaluation
				  of a laboratory's performance against pre-established criteria by means of
				  interlaboratory comparisons of test measurements.
(uu) "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
				  is known to the independent party, but is unknown to the testing laboratory and
				  testing laboratory employees.
(vv)
				  "Quadratic regression" 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
(ww) "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.
(xx) "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, laboratory control samples, replicate samples, and
				  reference material samples.
(yy)
				  "Reagent" means a compound or mixture added to a system to cause a chemical
				  reaction or 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.
(zz) "Reference
				  material" means material containing a known concentration of an analyte of
				  interest that is in solution or in a homogeneous matrix.
(aaa) "Reference method" means the method by
				  which the performance of an alternate method is measured or
				  evaluated.
(bbb) "Relative percent
				  difference" (RPD) means the comparative statistic that is used to calculate
				  precision or random error. RPD is calculated using the following equation:
RPD = | (representative sample measurement - replicate
					 sample measurement) / ([representative sample measurement + replicate sample
					 measurement] / 2) x 100%
(ccc) "Relative standard deviation" (RSD)
				  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
(ddd) "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.
(eee) "Representative
				  sample" means a sample that is comprised of several sample increments of
				  cannabis or cannabis products that are collected from a batch for
				  testing.
(fff) "Requester" means
				  the person who submits a request to the laboratory for testing of cannabis or
				  cannabis products from an entity licensed under the Act.
(ggg) "Reserve sample" means any portion of a
				  representative sample that was not used in the testing process.
(hhh) "Sample" means a representative part
				  of, or a single item from, a batch which is comprised of several sample
				  increments.
(jjj) "Sample
				  increment" means a portion of a batch that, together with other increments,
				  makes up the sample.
(kkk)
				  "Sampler" means the laboratory employee responsible for obtaining samples of
				  cannabis or cannabis products from a licensed distributor or licensed
				  microbusiness authorized to engage in distribution.
(lll) "Sanitize" means to sterilize,
				  disinfect, or make hygienic.
(mmm)
				  "Scope of accreditation" means the tests or types of tests performed, materials
				  or products tested, and the methods used for testing cannabis or cannabis
				  products for which the accreditation has been granted.
(nnn) "Standard operating procedure" (SOP)
				  means a written document that provides detailed instructions for the
				  performance of all aspects of an analysis, operation, or action.
(ooo) "Target organism" means an organism
				  that is being tested for in an analytical procedure or test method.
(ppp) "THCA" means tetrahydrocannabinolic
				  acid, CAS number 23978-85-0.
(qqq)
				  "Total CBD" means the sum of CBD and CBDA. Total CBD is calculated using the
				  following equation:
Total CBD concentration (mg/g) = (CBDA concentration (mg/g)
					 x 0.877) + CBD concentration (mg/g)
(rrr) "Total THC" means the sum of THC, delta
				  8 THC, and THCA. Total THC is calculated using the following equation:
Total THC (mg/g) = [(delta 8-THCA concentration (mg/g) +
					 delta 9-THCA concentration (mg/g)) x 0.877] + [delta 8-THC concentration (mg/g)
					 + delta 9-THC concentration (mg/g)]
(sss) "Validation" means the confirmation by
				  examination and objective evidence that the requirements for a specific
				  intended use or analytical method are fulfilled.
(ttt) "Water activity" means the measure of
				  the quantity of water in a product that is available and therefore capable of
				  supporting bacteria, yeasts, and fungi and which is reported in units
				  Aw.
1. Change
					 without regulatory effect relocating chapter 6 and article 1 from title 16,
					 division 42 and renumbering and amending former title 16, section
					 5700 to new title 4, section
					 15700 filed 7-14-2021 pursuant to
					 section 100, title 1, California Code of
					 Regulations (Register 2021, No. 29). For prior history of title 16, division
					 42, see Register 2019, No. 3.
2. Amendment filed 9-27-2021 as an
					 emergency; operative 9-27-2021 (Register 2021, No. 40). This filing is a deemed
					 emergency pursuant to Business and Professions Code sections
					 26013(b)(3)
					 and
					 26153.1(k).
					 A Certificate of Compliance must be transmitted to OAL by 3-28-2022 or
					 emergency language will be repealed by operation of law on the following
					 day.
3. Amendment refiled 3-28-2022 as an emergency; operative
					 3-28-2022 (Register 2022, No. 13). This filing is a deemed emergency pursuant
					 to Business and Professions Code sections
					 26013(b)(3)
					 and
					 26153.1(k).
					 A Certificate of Compliance must be transmitted to OAL by 9-26-2022 or
					 emergency language will be repealed by operation of law on the following
					 day.
4. Certificate of Compliance as to 3-28-2022 order, including
					 amendment of first paragraph and subsections (o) and (rrr), transmitted to OAL
					 9-26-2022 and filed 11-7-2022; amendments effective 11-7-2022 pursuant to
					 Government Code section
					 11343.4(b)(3)
					 (Register 2022, No. 45).
Note: Authority cited: Section
						26013,
						Business and Professions Code. Reference: Sections
						26013
						and
						26100,
						Business and Professions Code.