Cal. Code Regs. Tit. 4, § 15700 - Definitions
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.
Notes
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.
2. Amendment filed 9-27-2021 as an emergency; operative
3. Amendment refiled 3-28-2022 as an emergency; operative
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
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