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Chapter 6 (Testing Laboratories) of the Bureau of Cannabis Control ("Bureau" or "BCC") Text of Regulations covers regulations specific to licensed cannabis testing laboratories.
In addition to the definitions in section 5000 of this division, the following definitions apply to this chapter.
§ 5700 (a) “Acceptance criteria” means the specified limits placed on the characteristics of an item or method that are used to determine data quality.
§ 5700 (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.
§ 5700 (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.
§ 5700 (d) “Action level” means the threshold value that provides the criterion for determining whether
a sample passes or fails an analytical test.
§ 5700 (e) “Analyte” means a chemical, compound, element, bacteria, yeast, fungus, or toxin to be identified or measured.
§ 5700 (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.
§ 5700 (g) “Analytical method” means a technique used qualitatively or quantitatively to determine the composition of a sample or a microbial contamination of a sample.
§ 5700 (h) “Analytical sequence” means a group of samples that are analyzed sequentially using the same instrument calibration curve.
§ 5700 (i) “Cannabinoid” means a class of diverse chemical compounds derived from a cannabis plant.
§ 5700 (j) “Cannabis concentrate” means cannabis that has undergone a process to concentrate one or more active cannabinoids, thereby increasing the product’s potency. For purposes of this chapter, “cannabis concentrate” includes, but is not limited to, 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.
§ 5700 (k) “CAS number” means the unique numerical identifier assigned to every chemical substance by Chemical Abstracts Service, a division of the American Chemical Society.
§ 5700 (l) “CBD” means cannabidiol, CAS number 13956-29-1.
§ 5700 (m) “CBDA” means cannabidiolic acid, CAS number 1244-58-2.
§ 5700 (n) “CBG” means cannabigerol, CAS number 25654-31-3.
§ 5700 (o) “CBN” means cannabinol, CAS number 521-35-7.
§ 5700 (p) “Certificate of accreditation” means a document issued by an accreditation body that attests to the laboratory’s competence to carry out specific testing analysis.
§ 5700 (q) “Certificate of analysis” (COA) means the report prepared by the laboratory about the analytical testing performed and results obtained by the laboratory.
§ 5700 (r) “Certified reference material” means a reference material prepared by a certifying body or a party independent of the laboratory with ISO/IEC 17034 accreditation.
§ 5700 (s) “Chain of Custody” (COC) means the chronological documentation that records the sequence of custody, control, transfer, analysis, and disposal of a sample.
§ 5700 (t) “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.
§ 5700 (u) “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.
§ 5700 (v) “Corrective action” means an action taken by the laboratory to resolve, and prevent from recurrence, a problem with the technical operations of the laboratory.
§ 5700 (w) “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.
§ 5700 (x) “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.
§ 5700 (y) “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.
§ 5700 (z) “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.
§ 5700 (aa) “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.
§ 5700 (bb) “Inhalable” means consumable in gaseous or vapor form through the lungs.
§ 5700 (cc) “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.
§ 5700 (dd) “ISO/IEC” means the joint technical committee of the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC).
§ 5700 (ee) “ISO/IEC 17025” means the general requirements specified by the ISO/IEC for the competence of testing and calibration laboratories.
§ 5700 (ff) “ISO/IEC 17034” means the general requirements established by the ISO/IEC for the competence of reference material producers.
§ 5700 (gg) “ISO/IEC 17043” means the general requirements established by the ISO/IEC for proficiency testing.
§ 5700 (hh) “Laboratory” means “testing laboratory” as defined at Business and Professions Code section 26001(at).
§ 5700 (ii) “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.
§ 5700 (jj) “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.
§ 5700 (kk) “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.
§ 5700 (ll) “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.
§ 5700 (mm) “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.
§ 5700 (nn) “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.
§ 5700 (oo) “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
§ 5700 (pp) “Matrix” means the substances that are present in a sample except for the analyte(s) of interest.
§ 5700 (qq) “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.
§ 5700 (rr) “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.
§ 5700 (ss) “Moisture content” means the percentage of water in a sample, by weight.
§ 5700 (tt) “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.
§ 5700 (uu) “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.
§ 5700 (vv) “Orally-dissolving product” 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. Orally dissolving products are not intended to be eaten or swallowed to enter the digestive system.
§ 5700 (ww) “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.
§ 5700 (xx) “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.
§ 5700 (yy) “Pre-roll” has the same meaning as in section 5000(q) of this division and also includes, for purposes of this chapter, pre-rolls infused with cannabis concentrate.
§ 5700 (zz) “Proficiency test” means an evaluation of a laboratory’s performance against preestablished criteria by means of interlaboratory comparisons of test measurements.
§ 5700 (aaa) “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.
§ 5700 (bbb) “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
§ 5700 (ccc) “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.
§ 5700 (ddd) “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.
§ 5700 (eee) “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.
§ 5700 (fff) “Reference material” means material containing a known concentration of an analyte of interest that is in solution or in a homogeneous matrix.
§ 5700 (ggg) “Reference method” means the method by which the performance of an alternate method is measured or evaluated.
§ 5700 (hhh) “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) × 100%
§ 5700 (iii) “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) × 100%; where s = standard deviation and x = mean
§ 5700 (jjj) “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.
§ 5700 (kkk) “Representative sample” means a sample that is comprised of several sample increments of cannabis goods that are collected from a batch for testing.
§ 5700 (lll) “Requester” means the person who submits a request to the laboratory for testing of cannabis goods from an entity licensed under the Act.
§ 5700 (mmm) “Reserve sample” means any portion of a representative sample that was not used in the testing process.
§ 5700 (nnn) “Sample” means a representative part of, or a single item from, a batch which is comprised of several sample increments.
§ 5700 (ooo) “Sample increment” means a portion of a batch that, together with other increments, makes up the sample.
§ 5700 (ppp) “Sampler” means the laboratory employee responsible for obtaining samples of cannabis goods from a licensed distributor or licensed microbusiness authorized to engage in distribution.
§ 5700 (qqq) “Sanitize” means to sterilize, disinfect, or make hygienic.
§ 5700 (rrr) “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.
§ 5700 (sss) “Standard operating procedure” (SOP) means a written document that provides detailed
instructions for the performance of all aspects of an analysis, operation, or action.
§ 5700 (ttt) “Target organism” means an organism that is being tested for in an analytical procedure or test method.
§ 5700 (uuu) “THC” and “delta-9 THC” means tetrahydrocannabinol, CAS number 1972-08-3.
§ 5700 (vvv) “THCA” means tetrahydrocannabinolic acid, CAS number 23978-85-0.
§ 5700 (www) “Topical cannabis goods” means cannabis products intended to be applied to the skin and not intended to be ingested or inhaled. Liquid solutions that contain more than 0.5% alcohol by volume as an ingredient and are not otherwise an alcoholic beverage as defined in Business and Professions Code section 23004 shall only be considered topical cannabis goods if they are packaged in a container no larger than two (2) fluid ounces.
§ 5700 (xxx) “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)
§ 5700 (yyy) “Total THC” means the sum of THC and THCA. Total THC is calculated using the following equation:
Total THC concentration (mg/g) = (THCA concentration (mg/g) x 0.877) + THC concentration (mg/g)
§ 5700 (zzz) “Validation” means the confirmation by examination and objective evidence that the requirements for a specific intended use or analytical method are fulfilled.
§ 5700 (aaaa) “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.
Authority: Section 26013, Business and Professions Code.
Reference: Sections 26013 and 26100, Business and Professions Code.
§ 5701 (a) A licensed laboratory shall maintain ISO/IEC 17025 accreditation for the testing of the
following:
(1) Cannabinoids;
(2) Heavy metals;
(3) Microbial impurities;
(4) Mycotoxins;
(5) Residual pesticides;
(6) Residual solvents and processing chemicals; and
(7) If tested, terpenoids.
§ 5701 (b) Each testing laboratory licensed premises shall have ISO/IEC 17025 accreditation.
§ 5701 (c) A licensed laboratory shall retain, and make available to the Bureau upon request, all records associated with the licensee’s ISO/IEC 17025 certificate of accreditation.
Authority: Section 26013, Business and Professions Code.
Reference: Sections 26012 and 26100, Business and Professions Code.
In addition to the information required in section 5002 of this division, an application for a testing laboratory license includes the following:
§ 5702 (a) A valid certificate of accreditation, issued by an accreditation body, that attests to the laboratory’s competence to perform testing, including all the required analytes for the following test methods:
(1) Cannabinoids;
(2) Heavy metals;
(3) Microbial impurities;
(4) Mycotoxins;
(5) Residual pesticides;
(6) Residual solvents and processing chemicals; and
(7) If tested, terpenoids.
§ 5702 (b) Standard operating procedures for the following testing methods:
(1) Cannabinoids;
(2) Foreign material;
(3) Heavy metals;
(4) Microbial impurities;
(5) Moisture content and water activity;
(6) Mycotoxins;
(7) Residual pesticides;
(8) Residual solvents and processing chemicals; and
(9) If tested, terpenoids.
§ 5702 (c) Method validation reports for the following testing methods:
(1) Cannabinoids;
(2) Heavy metals;
(3) Microbial impurities;
(4) Water activity;
(5) Mycotoxins;
(6) Residual pesticides;
(7) Residual solvents; and processing chemicals; and
(8) If tested, terpenoids.
§ 5702 (d) Standard operating procedures for the sampling of cannabis goods.
Authority: Section 26013, Business and Professions Code.
Reference: Sections 26012, 26050, 26055, 26102 and 26104, Business and Professions Code.
§ 5703 (a) An applicant may apply for an interim license prior to receiving ISO/IEC 17025 accreditation
provided that the applicant meets all other licensure requirements for a testing laboratory and
submits to the Bureau an application in compliance with section 5002 of this division and an
attestation that the applicant has or intends to seek ISO/IEC 17025 accreditation for all testing
methods required by this division.
§ 5703 (b) An interim testing laboratory license shall be valid for 12 months. The annual license fee for
an interim license shall be determined pursuant to the requirements in section 5014 of this
division for determining the annual license fee for a testing laboratory license.
§ 5703 (c) To timely renew an interim license, a completed license renewal form and the annual renewal
license fee pursuant to section 5014 of this division shall be received by the Bureau from the
licensee no earlier than 60 calendar days before the expiration of the license and no later than 5:00 p.m. Pacific Time on the last business day before the expiration of the license if the renewal form is submitted to the Bureau at its office(s), or no later than 11:59 p.m. on the last business day before the expiration of the license if the renewal form is submitted to the Bureau through its electronic licensing system. Failure to receive a notice for license renewal does not relieve a licensee of the obligation to renew an interim license as required.
§ 5703 (d) In the event the license is not renewed prior to the expiration date, the licensee must not test
any commercial cannabis goods until the license is renewed.
§ 5703 (e) A licensee may submit a license renewal form up to 30 calendar days after the license
expires. Any late renewal form will be subject to a late fee equal to 50 percent of the applicable
licensing fees required by subsection (c) of this section.
§ 5703 (f) The license renewal application shall contain the following:
(1) The name of the licensee. For licensees who are individuals, the applicant shall provide both
the first and last name of the individual. For licensees who are business entities, the licensee shall
provide the legal business name of the applicant;
(2) The license number and expiration date;
(3) The licensee’s address of record and licensed premises address; and
(4) An attestation that all information provided to the Bureau in the original application under
section 5002 of this division or subsequent notification under section 5023 of this division is
accurate and current
§ 5703 (g) The Bureau may renew an interim license for an initial renewal period of 12 months.
§ 5703 (h) After one renewal, the Bureau may renew the interim license for additional 12-month
periods if the licensee has submitted an application for the ISO/IEC 17025 accreditation. In
addition to the information required for a renewal form pursuant to subsection (f) of this
section, any renewal request pursuant to this section shall also include an attestation that the
licensee’s application for each ISO/IEC 17025 is pending with the accrediting body, the name of
the accrediting body, and the date the application was submitted to the accrediting body.
§ 5703 (i) The licensee shall notify the Bureau if the application for each ISO/IEC 17025 accreditation is
granted or denied within 1 business day of receiving the decision from the accrediting body. The
Licensee shall submit to the Bureau the information required, on the Notification and Request
Form, BCC-LIC-027 (New 10/18), which is incorporated herein by reference. If the accrediting
body grants or denies the licensee’s application for any ISO/IEC 17025 accreditation before the
expiration of the interim license, the Bureau may terminate the interim license at that time.
§ 5703 (j) The Bureau may revoke an interim license at any time.
Authority: Section 26013, Business and Professions Code.
Reference: Sections 26012, 26031, 26050 and 26102, Business and Professions Code.
(A) Calling the local law enforcement agency. Timely calls to the local law enforcement agency that are placed by the licensee, or his or her agents or employees, shall not be construed by the Bureau as evidence of objectionable conditions that constitute a nuisance.
(B) Requesting those persons engaging in activities causing objectionable conditions to cease those activities, unless the licensee, or his or her agents or employees, feel that their personal safety would be threatened in making that request.
(C) Making good faith efforts to remove items that facilitate loitering, such as furniture, except those structures approved or permitted by the local jurisdiction. The licensee shall not be liable for the removal of those items that facilitate loitering.
§ 5704 (a) The laboratory shall develop and implement a sampling standard operating procedure (SOP) that describes the laboratory’s method for obtaining representative samples of cannabis goods.
The laboratory shall use and submit to the Bureau Sampling – Standard Operating Procedures,
Form BCC-LIC-021 (New 7/18), which is incorporated herein by reference.
§ 5704 (b) The laboratory shall retain a copy of the sampling SOP on the licensed laboratory premises
and ensure that the sampling SOP is accessible to the sampler during sampling.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26100, 26102,
26104 and 26110, Business and Professions Code.
§ 5711 (a) The laboratory shall develop, implement, and maintain written standard operating procedures
(SOP) for sample preparation and each required test method. The laboratory shall use and submit
to the Bureau the following forms which are incorporated by reference:
(1) Sample Preparation – Standard Operating Procedures, Form BCC-LIC-022 (New 7/18),
which is incorporated herein by reference; and
(2) Test Methods – Standard Operating Procedures, Form BCC-LIC-023 (New 7/18), which is
incorporated herein by reference.
§ 5711 (b) The laboratory shall keep each SOP at the licensed laboratory premises and ensure that
each SOP is accessible to laboratory employees during operating hours.
§ 5711 (c) The laboratory shall make each SOP available for inspection by the Bureau upon request, as
well as any other SOPs associated with the licensee’s ISO/IEC 17025 certificate of accreditation.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26012, 26100,
26104 and 26110, Business and Professions Code.
§ 5712 (a) The laboratory shall develop, implement, and validate test methods for the analyses
of samples as required under this division.
§ 5712 (b) To the extent practicable, the laboratory test methods shall comport with the
following guidelines:
(1) US Food and Drug Administration’s Bacterial Analytical Manual, 2016;
(2) AOAC International’s Official Methods of Analysis for Contaminant Testing of
AOAC International, 20th Edition, 2016; and
(3) United States Pharmacopeia and the National Formulary’s Methods of Analysis
for Contaminant Testing, 2016.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26012, 26100,
26104 and 26110, Business and Professions Code.
§ 5713 (a) The laboratory may use a nonstandard, amplified, or modified test method or a method that is
designed or developed by the laboratory to validate the methods for analyses of samples.
§ 5713 (b) The laboratory shall follow the guidelines set forth in the US Food and Drug
Administration’s Guidelines for the Validation of Analytical Methods for the Detection of
Microbial Pathogens in Foods and Feeds, 2nd Edition, April 2015, incorporated herein by
reference, to validate test methods for the microbial analysis of samples. The laboratory shall
include and address the criteria listed in the following table when validating test methods for
microbial analyses of samples.
(1) The laboratory shall include and address the following criteria to validate test methods for
chemical analyses of samples:
(A) Accuracy;
(B) Precision;
(C) Linearity and range;
(i) The Coefficient of Determination (r2) for all calibration curves shall be greater than or equal
to 0.99.
(ii) Linear regression or quadratic regression shall only be used for calibration curves. Curves
shall not be weighted at all or only weighted at ⅟x.
(iii) LOQ for analytes tested shall be within the range of the calibration curve.
(D) Calibration standard;
(i) For calibration curves, there shall be a minimum of five calibration standards, not including
zero; and
§ 5713 (c) The laboratory shall follow the guidelines set forth in the US Food and Drug
Administration’s Guidelines for the Validation of Chemical Methods for the FDA FVM
Program, 2nd Edition, April 2015, incorporated herein by reference, to validate test methods for
chemical analysis of samples.
§ 5713 (d) The laboratory shall generate a validation report for each test method. Each validation report
shall include the following information:
(1) Instrument calibration data, if any;
(2) Raw data, including instrument raw data, for each test method, if any;
(3) Cannabis reference materials or certified reference material results;
(4) Data and calculations pertaining to LOD and LOQ determinations, if any;
(5) LQC report, as described in this chapter, for the validation of each method; and
(6) Worksheets, forms, pictures, or copies of laboratory notebook pages and any other
documentation necessary to meet the requirements described in subsections (b) and (c) of this
section.
(7) The supervisory or management laboratory employee shall review, approve, sign, and date
the validation report for each test method.
(8) Upon new test methods or altered test methods being used in the laboratory, the new
validation report shall be submitted to the Bureau within 5 business days, accompanied by the
Notification and Request Form, BCC-LIC-027 (New 10/18), which is incorporated herein by reference.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26012, 26100,
26102, 26104 and 26110, Business and Professions Code.
§ 5714 (a) All sample increments collected must be homogenized prior to sample analyses,
notwithstanding foreign material testing.
§ 5714 (b) The laboratory shall test each representative sample for the following:
(1) Quality control procedures;
(2) Laboratory organization and employee training and responsibilities, including good laboratory practice (GLP);
(3) LQA objectives for measurement data;
(4) Traceability of data and analytical results;
(5) Instrument maintenance, calibration procedures, and frequency;
(6) Performance and system audits;
(7) Corrective action procedures;
(8) Steps to change processes when necessary;
(9) Record retention and document control;
(10) Test procedure standardization; and
(11) Method validation.
§ 5714 (c) The laboratory shall report the results of each analysis performed by the laboratory on the
certificate of analysis.
§ 5714 (d) The laboratory that obtained the representative sample shall complete all required testing for each representative sample for regulatory compliance testing.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26100, 26104
and 26110, Business and Professions Code.
§ 5715 (a) Cannabis goods shall not be sold or transferred to a licensed retailer or licensed microbusiness,
or released for retail sale, unless a representative sample of the cannabis goods has undergone and
passed all testing as required by this section.
§ 5715 (b) All cannabis harvested on or after January 1, 2018, and all cannabis products manufactured
on or after January 1, 2018, shall be tested for the following analytes, if applicable:
(1) Cannabinoids as required in section 5724 of this division;
(2) Moisture content as required in section 5717 of this division;
(3) Category II Residual Solvents and Processing Chemicals as required in section 5718 of this
division;
(4) Category I Residual Pesticides as required in section 5719 of this division; and
(5) Microbial Impurities as required in section 5720 of this division.
§ 5715 (c) In addition to the requirements of subsection (b) of this section, all cannabis harvested on or
after July 1, 2018, and all cannabis products manufactured on or after July 1, 2018, shall be
tested for the following analytes, if applicable:
(1) Category I Residual Solvents and Processing Chemicals as required in section 5718 of this
division;
(2) Category II Residual Pesticides as required in section 5719 of this division; and
(3) Foreign Material as required in section 5722 of this division.
§ 5715 (d) In addition to the requirements in subsections (b) and (c) of this section, all cannabis
harvested on or after December 31, 2018, and all cannabis products manufactured on or after
December 31, 2018, shall be tested for the following analytes, if applicable:
(1) Terpenoids as required in section 5725 of this division;
(2) Mycotoxins as required in section 5721 of this division;
(3) Heavy Metals as required in section 5723 of this division; and
(4) Water Activity as required in section 5717 of this division.
§ 5715 (e) Licensees may have a sample of cannabis goods tested for analytes that are not yet required
to be tested. However, if the sample fails any additional test(s) not required pursuant to this
section on the date of testing, the batch from which the sample was collected fails testing and
shall not be released for retail sale.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26100,
26104 and 26110, Business and Professions Code.
§ 5717 (a) The laboratory shall analyze at minimum 0.5 grams of the representative sample of dried
flower to determine the level of water activity and the percentage of moisture content.
(1) The dried flower sample, including pre-rolls, shall be deemed to have passed water activity
testing if the water activity does not exceed 0.65 Aw. The laboratory shall report the result of
the water activity test on the certificate of analysis (COA) and indicate “pass” or “fail” on the
COA.
(2) The laboratory shall report the result of the moisture content test on the COA as a percentage.
§ 5717 (b) The laboratory shall analyze at least 0.5 grams of the representative sample of solid edible
cannabis products to determine the level of water activity. A solid edible cannabis product shall
be deemed to have passed water activity testing if the water activity does not exceed 0.85 Aw. The laboratory shall report the result of the water activity test on the COA and indicate “pass” or
“fail” on the COA.
(c) If the sample fails water activity testing, the batch from which the sample was collected fails
water activity testing and shall not be released for retail sale.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26100, 26104
and 26110, Business and Professions Code.
§ 5718 (a) The laboratory shall analyze at minimum 0.25 grams of the representative sample of
cannabis product or pre-rolls to determine whether residual solvents or processing chemicals are
present.
§ 5718 (b) The laboratory shall report the result of the residual solvents and processing chemicals testing
in unit micrograms per gram (µg/g) on the COA and indicate “pass” or “fail” on the COA.
§ 5718 (c) The sample shall be deemed to have passed the residual solvents and processing chemicals
testing if the presence of any residual solvent or processing chemical listed in the following
tables in Category I and Category II does not exceed the indicated action levels.
(1) Notwithstanding subsection (c), the limit for ethanol does not apply to cannabis goods that
are intended to be orally-consumed products containing alcohol as defined in section 5700 of this
division.
(2) Notwithstanding subsection (c), the limit for ethanol or isopropyl alcohol does not apply to
cannabis goods that are intended to be topical cannabis goods as defined in section 5700 of this
division.
§ 5718 (d) If the sample fails residual solvents and processing chemicals testing, the batch from which
the sample was collected fails residual solvents and processing chemicals testing and shall not
be released for retail sale.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26100,
26104 and 26110, Business and Professions Code.
§ 5719 (a) The laboratory shall analyze at minimum 0.5 grams of the representative sample of
cannabis goods to determine whether residual pesticides are present.
§ 5719 (b) The laboratory shall report whether any Category I Residual Pesticides are detected above the
limit of detection (LOD) and shall report the result of the Category II Residual Pesticides testing
in unit micrograms per gram (µg/g) on the COA. The laboratory shall indicate “pass” or “fail” on
the COA.
§ 5719 (c) The laboratory shall establish a limit of quantitation (LOQ) of 0.10 µg/g or lower for all
Category I Residual Pesticides.
§ 5719 (d) The sample shall be deemed to have passed the residual pesticides testing if both of the
following conditions are met:
(1) The presence of any residual pesticide listed in the following tables in Category I are not
detected, and
(2) The presence of any residual pesticide listed in the following tables in Category II does not
exceed the indicated action levels.
§ 5719 (e) If the sample fails residual pesticides testing, the batch from which the sample was
collected fails residual pesticides testing and shall not be released for retail sale.
Authority: Section 26013, Business and Professions Code. Reference: Sections
26100, 26104 and 26110, Business and Professions Code.
§ 5720 (a) The laboratory shall analyze at minimum 1.0 grams of the representative sample of
cannabis goods to determine whether microbial impurities are present.
§ 5720 (b) The laboratory shall report the result of the microbial impurities testing by
indicating “pass” or “fail” on the COA.
§ 5720 (c) The sample of inhalable cannabis goods shall be deemed to have passed the
microbial impurities testing if all of the following conditions are met:
(1) Shiga toxin–producing Escherichia coli is not detected in 1 gram;
(2) Salmonella spp. is not detected in 1 gram; and
(3) Pathogenic Aspergillus species A. fumigatus, A. flavus, A. niger, and A.
terreus are not detected in 1 gram.
§ 5720 (d) The sample of non-inhalable cannabis goods shall be deemed to have passed the
microbial impurities testing if both the following conditions are met:
(1) Shiga toxin–producing Escherichia coli is not detected in 1 gram, and
(2) Salmonella spp. is not detected in 1 gram.
§ 5720 (e) If the sample fails microbial impurities testing, the batch from which the
sample was collected fails microbial impurities testing and shall not be released
for retail sale.
Authority: Section 26013, Business and Professions Code. Reference: Sections
26100, 26104 and 26110, Business and Professions Code.
§ 5721 (a) The laboratory shall analyze at minimum 0.5 grams of the representative sample of
cannabis goods to determine whether mycotoxins are present.
§ 5721 (b) The laboratory shall report the result of the mycotoxins testing in unit
micrograms per kilograms (µg/kg) on the COA and indicate “pass” or “fail” on
the COA.
§ 5721 (c) The sample shall be deemed to have passed mycotoxin testing if both the following
conditions are met:
(1) Total of aflatoxin B1, B2, G1, and G2 does not exceed 20 µg/kg of substance, and
(2) Ochratoxin A does not exceed 20 µg/kg of substance.
§ 5721 (d) If the sample fails mycotoxin testing, the batch from which the sample was collected fails
mycotoxin testing and shall not be released for retail sale.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26100, 26104
and 26110, Business and Professions Code.
§ 5722 (a) (a) The laboratory shall analyze the representative sample of cannabis goods to determine
whether foreign material is present.
§ 5722 (b) The laboratory shall report the result of the foreign material test by indicating “pass” or
“fail” on the COA.
§ 5722 (c) The laboratory shall perform foreign material testing on the total representative sample prior to sample homogenization.
§ 5722 (d) When the laboratory performs foreign material testing, at minimum, the laboratory shall
do all of the following:
(1) Examine both the exterior and interior of the dried flower sample, and
(2) Examine the exterior of the cannabis product sample.
§ 5722 (e) The sample shall be deemed to have passed the foreign material testing if the presence of
foreign material does not exceed:
(1) 1/4 of the total sample area covered by sand, soil, cinders, or dirt;
(2) 1/4 of the total sample area covered by mold;
(3) 1 insect fragment, 1 hair, or 1 count mammalian excreta per 3.0 grams; or
(4) 1/4 of the total sample area covered by an imbedded foreign material.
§ 5722 (f) If the sample fails foreign material testing, the batch from which the sample was collected
fails foreign material testing and shall not be released for retail sale.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26100, 26104
and 26110, Business and Professions Code.
§ 5723 (a) The laboratory shall analyze at minimum 0.5 grams of the representative sample of cannabis
goods to determine whether heavy metals are present.
§ 5723 (b) The laboratory shall report the result of the heavy metals test in unit micrograms per
gram (µg/g) on the COA and indicate “pass” or “fail” on the COA.
§ 5723 (c) The sample shall be deemed to have passed the heavy metals testing if the presence of
heavy metals does not exceed the action levels listed in the following table.
§ 5723 (d) If the sample fails heavy metals testing, the batch from which the sample was collected fails
heavy metals testing and shall not be released for retail sale.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26100, 26104 and 26110, Business and Professions Code.
§ 5724 (a) The laboratory shall analyze at minimum 0.5 grams of the representative sample of cannabis
goods to determine the cannabinoid profile such as THC; THCA; CBD; CBDA; CBG; and CBN.
§ 5724 (b) The laboratory shall establish a limit of quantitation (LOQ) of 1.0 mg/g or lower for
all cannabinoids analyzed and reported.
§ 5724 (c) The laboratory shall report the result of the cannabinoid testing on the COA, including, at
minimum:
(1) A percentage for THC, THCA, CBD, and CBDA;
(A) When the laboratory reports the result of the cannabinoid testing for harvest batch
representative samples on the COA in dry-weight percent, they shall use the following equation:
Dry-weight percent cannabinoid = wet-weight percent cannabinoid / (1 − percent
moisture / 100)
(2) A percentage for Total THC and Total CBD, if applicable;
(3) Milligrams per gram (mg/g) if by dry-weight or milligrams per milliliter (mg/mL) if by
volume for THC, THCA, CBD, and CBDA.
(4) Milligrams per gram (mg/g) if by dry-weight or milligrams per milliliter (mg/mL) if by
volume for Total THC and Total CBD, if applicable;
(A) The laboratory shall calculate the total cannabinoid concentration as follows:
(i) For concentration expressed in weight:
Total cannabinoid concentration (mg/g) = (cannabinoid acid form concentration (mg/g)
x 0.877) + cannabinoid concentration (mg/g)
(ii) For concentration expressed in volume:
Total cannabinoid concentration (mg/mL) = (cannabinoid acid form
concentration (mg/mL) x 0.877) + cannabinoid concentration (mg/mL)
(5) Milligrams per package for THC and CBD;
(6) Milligrams per package for Total THC and Total CBD, if applicable;
(7) Milligrams per serving for THC and CBD, if any;
(8) Milligrams per serving for Total THC and Total CBD, if any and if applicable; and
(9) The laboratory shall report the results of all other cannabinoids analyzed on the COA both
as a percentage and in either milligrams per gram (mg/g) if by weight or milligrams per milliliter
(mg/mL) if by volume.
§ 5724 (d) The sample shall be deemed to have passed the cannabinoid testing if the following
conditions are met:
(1) For all edible cannabis products, the milligrams per serving for THC does not exceed 10
milligrams per serving.
(2) For edible cannabis products that are not orally-dissolving products labeled “FOR
MEDICAL USE ONLY”, the milligrams per package for THC does not exceed 100 milligrams
per package.
(3) For edible cannabis products that are orally-dissolving products labeled “FOR MEDICAL
USE ONLY,” the milligrams per package for THC does not exceed 500 milligrams per package.
(4) For cannabis concentrates and topical cannabis goods not labeled “FOR MEDICAL USE
ONLY,” the milligrams per package for THC does not exceed 1000 milligrams per package.
(5) For cannabis concentrates and topical cannabis goods labeled “FOR MEDICAL USE
ONLY,” the milligrams per package for THC does not exceed 2000 milligrams per package.
§ 5724 (e) The laboratory shall report the test results and indicate an overall “pass” or “fail” for the
cannabinoid testing on the COA.
§ 5724 (f) Any cannabinoids found to be less than the LOQ shall be reported on the COA as “<1 mg/g”
if by dry-weight or “<1 mg/mL” if by volume.
§ 5724
(g) If the sample fails cannabinoid testing, the batch from which the sample was collected fails
cannabinoid testing and shall not be released for retail sale.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26100, 26104
and 26110, Business and Professions Code.
§ 5725 (a) If requested, the laboratory shall analyze at minimum 0.5 grams of the representative
sample of cannabis goods to determine the terpenoid profile of the sample.
§ 5725 (b) The laboratory shall report the result of the terpenoid testing on the COA both as a
percentage and in either milligrams per gram (mg/g) if by weight or milligrams per milliliter
(mg/mL) if by volume.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26100, 26104 and
26110, Business and Professions Code.
§ 5726 (a) The laboratory shall generate a COA for each representative sample that the laboratory
analyzes.
§ 5726 (b) The laboratory shall ensure that the COA contains the results of all required analyses
performed for the representative sample.
§ 5726 (c) The laboratory shall, within 1 business day of completing all analyses of a sample, both
upload the COA into the track and trace system and simultaneously provide a copy of the
COA to the Bureau via email at bcc.labs@dca.ca.gov.
§ 5726 (d) The laboratory shall not release to any person any cumulative or individual test results
prior to completing all analyses and providing the COA to the Bureau.
§ 5726 (e) The COA shall contain, at minimum, the following information:
(1) The term “Regulatory Compliance Testing” in font no smaller than 14-point, which shall appear in the upper-right corner of each page of the COA. No text or images shall appear above the term “Regulatory Compliance Testing” on any page of the COA.
(2) Laboratory’s name, licensed premises address, and license number;
(3) Licensed distributor’s or licensed microbusiness authorized to engage in distribution’s name, licensed premises address, and license number;
(4) Licensed cultivator’s, licensed manufacturer’s, or licensed microbusiness’ name, licensed premises address, and license number;
(5) Batch number of the batch from which the sample was obtained. For cannabis goods that are already packaged at the time of sampling, the labeled batch number on the packaged cannabis goods shall match the batch number on the COA;
(6) Sample identifying information, including matrix type and unique sample identifiers;
(7) Sample history, including the date collected, the date received by the laboratory, and the date(s) of sample analyses and corresponding testing results;
(8) A picture of the sample of cannabis goods. If the sample is pre-packaged, the picture must include an unobstructed image of the packaging;
(9) For dried flower samples, the total weight of the batch, in grams or pounds, and the total weight, of the representative sample in grams;
(10) For cannabis product or pre-rolls samples, the total unit count of both the representative sample and the total batch size;
(11) Measured density of the cannabis goods;
(12) The analytical methods, analytical instrumentation used, and corresponding Limits of Detection (LOD) and Limits of Quantitation (LOQ);
(13) An attestation on the COA from the laboratory supervisory or management employee that all LQC samples required by section 5730 of this division were performed and met the acceptance criteria; and
(14) Analytes detected during the analyses of the sample that are unknown, unidentified, or injurious to human health if consumed, if any.
§ 5726 (f) The laboratory shall report test results for each representative sample on the COA as follows:
(1) Indicate an overall “pass” or “fail” for the entire batch;
(2) When reporting qualitative results for each analyte, the laboratory shall indicate “pass” or “fail”;
(3) When reporting quantitative results for each analyte, the laboratory shall use the appropriate units of measurement as required under this chapter;
(4) When reporting results for each test method, the laboratory shall indicate “pass” or “fail”;
(5) When reporting results for any analytes that were detected below the analytical method LOQ, indicate “<LOQ”, notwithstanding cannabinoid results;
(6) When reporting results for any analytes that were not detected or detected below the LOD, indicate “ND”; and
(7) Indicate “NT” for any test that the laboratory did not perform.
§ 5726 (g) The laboratory supervisory or management employee shall validate the accuracy of the information contained on the COA and sign and date the COA.
Authority: Section 26013, Business and Professions Code.
Reference: Sections 26100, 26104 and 26110, Business and Professions Code.
§ 5727 (a) A cannabis goods batch that has been additionally processed after failed testing must be retested and successfully pass all the analyses required under this chapter.
§ 5727 (b) The licensed distributor or licensed microbusiness authorized to engage in distribution shall arrange for remediation of a failed cannabis goods batch. If the batch cannot be remediated, the batch shall be destroyed by the licensed distributor or licensed microbusiness authorized to engage in distribution.
§ 5727 (c) If a failed batch is not remediated or reprocessed in any way it cannot be retested. Any subsequent COAs produced without remediation or reprocessing of the failed batch will not supersede the initial regulatory compliance testing COA.
§ 5727 (d) A cannabis goods batch may only be remediated twice. If the batch fails after the second remediation attempt and the second retesting, the entire batch shall be destroyed.
§ 5727 (e) Within one business day of completing the required analyses of a representative sample obtained from a remediated cannabis goods batch, the laboratory shall upload the COA information into the track and trace system, or if the licensee does not yet have access to the track and trace system, it shall be emailed to the Bureau.
§ 5727 (f) Nothing in this section shall be interpreted to prevent a cannabis goods batch from being retested when the COA is 12 or more months old.
Authority: Section 26013, Business and Professions Code.
Reference: Sections 26100, 26104 and 26110, Business and Professions Code.
§ 5728 (a) The laboratory shall retain the reserve sample, consisting of any portion of a sample that was not used in the testing process. The reserve sample shall be kept, at minimum, for 45 business days after the analyses, after which time it may be destroyed and denatured to the point the material is rendered unrecognizable and unusable.
§ 5728 (b) The laboratory shall securely store the reserve sample in a manner that prohibits sample degradation, contamination, and tampering.
§ 5728 (c) The laboratory shall provide the reserve sample to the Bureau upon request.
Authority: Section 26013, Business and Professions Code.
Reference: Sections 26100, 26104 and 26110, Business and Professions Code.
§ 5729 (a) The laboratory shall develop and implement a LQA program to assure the reliability and validity of the analytical data produced by the laboratory. The LQA program shall, at minimum, include a written LQA manual that addresses the following:
(1) Quality control procedures;
(2) Laboratory organization and employee training and responsibilities, including good laboratory practice (GLP);
(3) LQA objectives for measurement data;
(4) Traceability of data and analytical results;
(5) Instrument maintenance, calibration procedures, and frequency;
(6) Performance and system audits;
(7) Corrective action procedures;
(8) Steps to change processes when necessary;
(9) Record retention and document control;
(10) Test procedure standardization; and
(11) Method validation.
§ 5729 (b) The supervisory or management laboratory employee shall annually review, amend if necessary, and approve the LQA program and manual both when they are created and when there is a change in methods, laboratory equipment, or the supervisory or management laboratory employee.
Authority: Section 26013, Business and Professions Code.
Reference: Sections 26100, 26104 and 26110, Business and Professions Code.
The laboratory shall use LQC samples and adhere to good laboratory practice (GLP) in the performance of each analysis according to the following specifications.
§ 5730 (b) The laboratory shall use at least one negative control, one positive control, and one laboratory replicate sample in each analytical batch for each target organism during microbial testing. If one of the controls produces unexpected results, the samples shall be re- prepped and reanalyzed with a new set of controls.
§ 5730 (c) If the result of the microbial analyses is outside the specified acceptance criteria in the following table, the laboratory shall determine the cause and take steps to remedy the problem until the result is within the specified acceptance criteria.
§ 5730 (d) The laboratory shall prepare and analyze at least one of each of the following LQC samples for each analytical batch:
(1) Method blank;
(2) Laboratory control sample (LCS); and
(3) Laboratory replicate sample or matrix spike sample.
§ 5730 (e) The laboratory shall analyze, at minimum, a continuing calibration verification (CCV) sample at the beginning of each analytical sequence and every 10 samples thereafter.
§ 5730 (f) If the result of the chemical analyses is outside the specified acceptance criteria in the following table, the laboratory shall determine the cause and take steps to remedy the problem until the result is within the specified acceptance criteria.
§ 5730 (g) If any analyte is detected above any action level, as described in this chapter, the sample shall be re-prepped and reanalyzed in replicate within another analytical batch.
(1) For quantitative analyses, the re-prepped sample and its associated replicate must meet the acceptance criteria of RPD ≤30%.
(2) For qualitative analyses, the re-prepped sample and its associated replicate results must concur.
§ 5730 (h) If any LQC sample produces a result outside of the acceptance criteria, the laboratory cannot report the result and the entire batch cannot be released for retail sale. The laboratory shall determine the cause and take steps to remedy the problem until the result is within the specified acceptance criteria.
§ 5730 (i) If the laboratory determines that the result is a false-positive or a false-negative, the Bureau may ask for the laboratory to re-sample or re-test.
§ 5730 (j) The laboratory shall compile and generate one LQC sample report for each analytical batch that includes LQC acceptance criteria, measurements, analysis date, and matrix.
Authority: Section 26013, Business and Professions Code.
Reference: Sections 26100, 26104 and 26110, Business and Professions Code.
§ 5731 (a) The laboratory shall calculate the LOD for chemical method analyses according to any of the following methods:
(1) Signal-to-noise ratio of between 3:1 and 2:1;
(2) Standard deviation of the response and the slope of calibration curve using a minimum of 7 spiked blank samples calculated as follows;
LOD = (3.3 x standard deviation of the response) / slope of the calibration curve; or
(3) A method published by the United States Food and Drug Administration (USFDA) or the United States Environmental Protection Agency (USEPA
§ 5731 (b) The laboratory shall calculate the LOQ for chemical method analyses according to any of the following methods:
(1) Signal-to-noise ratio of 10:1, at minimum;
(2) Standard deviation of the response and the slope using a minimum of 7 spiked blank
samples calculated as follows:
LOQ = (10 × standard deviation of the response) / slope of the calibration curve; or
(3) A method published by the USFDA or the USEPA.
Authority: Section 26013, Business and Professions Code.
Reference: Sections 26100, 26104 and 26110, Business and Professions Code.
§ 5732 (a) The laboratory shall compile and generate one data package for each representative sample that the laboratory analyzes.
§ 5732 (b)The laboratory shall create a data package and use the Data Package Cover Page and Checklist Form, BCC-LIC-024, which is incorporated herein by reference. The data package and form BCC-LIC-024 shall be provided to the Bureau immediately upon request.
Authority: Section 26013, Business and Professions Code.
Reference: Sections 26100, 26104, 26110 and 26160, Business and Professions Code.
§ 5733 (a) The laboratory shall participate in a proficiency testing program provided by an organization that operates in conformance with the requirements of ISO/IEC 17043, at least once every six months.
§ 5733 (b) The laboratory shall annually, successfully participate in a proficiency testing program for each of the following test methods:
(1) Cannabinoids;
(2) Heavy metals;
(3) Microbial impurities;
(4) Mycotoxins;
(5) Residual pesticides;
(6) Residual solvents and processing chemicals; and
(7) If tested, terpenoids.
§ 5733 (c) The laboratory shall report all analytes available by the proficiency testing program provider and for which the licensee is required to test as required under this chapter.
§ 5733 (d) The laboratory shall participate in the proficiency testing program by following the laboratory’s existing SOPs for testing cannabis goods.
§ 5733 (e) The laboratory shall rotate the proficiency testing program among the laboratory employees who perform the test methods.
§ 5733 (f) Laboratory employees who participate in a proficiency testing program shall sign the corresponding analytical reports or attestation statements to certify that the proficiency testing program was conducted in the same manner as the laboratory tests of cannabis goods.
§ 5733 (g) A supervisory or management laboratory employee shall review and verify the accuracy of results reported for all proficiency testing program samples analyzed.
§ 5733 (h) The laboratory shall request the proficiency testing program provider to send results concurrently to the Bureau, if available, or the laboratory shall provide the proficiency testing program results to the Bureau within 3 business days after the laboratory receives notification of their test results from the proficiency testing program provider. Any results shall be reported by submitting the Notification and Request Form, BCC-LIC-027 (New 10/18), which is incorporated herein by reference.
Authority: Section 26013, Business and Professions Code.
Reference: Sections 26100 and 26110, Business and Professions Code.
§ 5734 (a) The laboratory shall be deemed to have successfully participated in a proficiency testing program for an analyte tested in a specific method if the test results demonstrate a “satisfactory” or otherwise proficient performance determination by the proficiency testing program provider.
§ 5734 (b) The laboratory may not report test results for analytes that are deemed by the proficiency testing program provider as “unacceptable,” “questionable,” “unsatisfactory”, or otherwise deficient.
§ 5734 (c) The laboratory may resume reporting test results for analytes that were deemed “unacceptable,” “questionable,” “unsatisfactory”, or otherwise deficient, only if both of the following conditions are met:
(1) The laboratory satisfactorily remedies the cause of the failure for each analyte; and
(2) The laboratory submits, to the Bureau, a written corrective action report demonstrating how
the laboratory has fixed the cause of the failure.
Authority: Section 26013, Business and Professions Code.
Reference: Sections 26100 and 26110, Business and Professions Code.
§ 5735 (a) The laboratory shall conduct an internal audit at least once per year or in accordance with the ISO/IEC 17025 accrediting body’s requirement, whichever is more frequent.
§ 5735 (b) The internal audit must include all of the components required by the ISO/IEC 17025 internal-audit standards.
§ 5735 (c) Within 3 business days of completing the internal audit, the laboratory shall submit the results of the internal audit to the Bureau.
§ 5735 (d) Within 3 business days of receiving the accrediting body on-site audit findings, the laboratory shall submit the results to the Bureau.
§ 5735 (e) The laboratory shall submit any audit results to the Bureau, accompanied by the Notification and Request Form, BCC-LIC-027 (New 10/18), which is incorporated herein by reference.
Authority: Section 26013, Business and Professions Code.
Reference: Sections 26100 and 26104, Business and Professions Code.
§ 5736 (a) The laboratory may only employ persons who are at least 21 years of age.
§ 5736 (b) The laboratory shall develop and implement an employee training program to ensure competency of laboratory employees for their assigned functions.
§ 5736 (c) The laboratory shall ensure and document that each laboratory employee meets the employee qualifications.
Authority: Section 26013, Business and Professions Code.
Reference: Sections 26102 and 26104, Business and Professions Code.
§ 5737 (a) The laboratory shall employ a supervisor or management employee who must be responsible for:
(1) Overseeing and directing the scientific methods of the laboratory;
(2) Ensuring that the laboratory achieves and maintains a laboratory quality assurance program as required by section 5729 of this division; and
(3) Providing ongoing and appropriate training to laboratory employees.
(4) A bachelor’s degree in any field from an accredited college or university, plus at least 8
years of full-time practical experience, 4 years of which must have been in a supervisory or
management position.
§ 5737 (b) To be considered qualified, the supervisor or management employee must have at minimum:
(1) A doctoral degree in biological, chemical, agricultural, environmental, or related sciences from an accredited college or university;
(2) A master’s degree in biological, chemical, agricultural, environmental, or related sciences from an accredited college or university, plus at least 2 years of full-time practical experience;
(3) A bachelor’s degree in biological, chemical, agricultural, environmental, or related sciences from an accredited college or university, plus at least 4 years of full-time practical experience; or
(4) A bachelor’s degree in any field from an accredited college or university, plus at least 8
years of full-time practical experience, 4 years of which must have been in a supervisory or
management position.
Authority: Section 26013, Business and Professions Code.
Reference: Sections 26102 and 26104, Business and Professions Code.
§ 5738 (a) The laboratory shall employ an analyst who, at minimum, must have either:
(1) Earned a master’s degree or a bachelor’s degree in biological, chemical,
agricultural, environmental, or related sciences from an accredited college or university;
or
(2) Completed 2 years of college or university education that included coursework in
biological, chemical, agricultural, environmental, or related sciences from an accredited college
or university, plus at least 3 years of full-time practical experience.
§ 5738 (b) The laboratory shall employ a sampler who, at minimum, must have either:
(1) Completed 2 years college or university education;
or
(2) Earned a High School Diploma or passed a General Educational Development or High School Equivalency exam, plus at least 1 year of full-time practical experience.
Authority: Section 26013, Business and Professions Code.
Reference: Sections 26102 and 26104, Business and Professions Code.
All laboratory records described in this chapter shall be maintained in accordance with section 5037 of this division.
Authority: Section 26013, Business and Professions Code.
Reference: Section 26160, Business and Professions Code.
§ 5815 (a) The Bureau may issue an emergency decision and order for temporary, interim relief to prevent or avoid immediate danger to the public health, safety, or welfare. Such circumstances include, but are not limited to, the following:
(1) The Bureau has information that cannabis goods at a licensee’s premises have a reasonable probability of causing serious adverse health consequences or death.
(2) To prevent the sale, transfer, or transport of contaminated or illegal cannabis goods in possession of the licensee.
(3) The Bureau observes or has information that conditions at the licensee’s premises exist that present an immediate risk to worker or public health and safety.
(4) To prevent illegal diversion of cannabis goods, or other criminal activity at the licensee’s premises.
(5) To prevent the destruction of evidence related to illegal activity or violations of the Act.
(6) To prevent misrepresentation to the public, such as selling untested cannabis goods, providing inaccurate information about the cannabis goods, or cannabis goods that have been obtained from an unlicensed person.
§ 5815 (b) Temporary, interim relief may include a suspension or administrative hold by one or more of the following:
(1) The temporary suspension of a license.
(2) An order to segregate or isolate specific cannabis goods.
(3) An order prohibiting the movement of cannabis goods to or from the premises.
(4) (4) An order prohibiting the sale of specific cannabis goods.
(5) An order prohibiting the destruction of specific cannabis goods.
§ 5815 (c) The emergency decision and order issued by the Bureau shall include a brief explanation of the factual and legal basis of the emergency decision that justify the Bureau’s determination that emergency action is necessary, and the specific actions ordered. The emergency decision and order shall be effective when issued or as otherwise provided by the decision and order.
§ 5815 (d) To issue an administrative hold that prohibits activity related to specified cannabis goods, the Bureau shall comply with the following:
(1) The notice of the administrative hold shall include a description of the cannabis goods subject to the administrative hold.
(2) Following notice, the Bureau shall identify the cannabis goods subject to the administrative hold in the track and trace system.
§ 5815 (e) A licensee subject to an administrative hold shall comply with the following:
(1) Within 24 hours of receipt of the notice of administrative hold, physically segregate all designated cannabis goods in a limited-access area of the licensed premises. The licensee shall ensure that all cannabis goods subject to the administrative hold are safeguarded and preserved in a manner that prevents tampering, degradation, or contamination.
(2) While the administrative hold is in effect, the licensee shall not sell, donate, transfer, transport, gift, or destroy the cannabis goods subject to the hold.
(3) A microbusiness licensee subject to an administrative hold may continue to cultivate any cannabis subject to an administrative hold. If the cannabis subject to the hold must be harvested, the licensee shall place the harvested cannabis into separate batches.
(4) A licensee may voluntarily surrender cannabis goods that are subject to an administrative hold. The licensee shall identify the cannabis goods being voluntarily surrendered in the track and trace system. Voluntary surrender shall not be construed to waive the right to a hearing or any associated rights.
§ 5815 (f) To issue a temporary suspension, the Bureau shall specify in the order that the licensee shall immediately cease conducting all commercial cannabis activities under its license, unless otherwise specified in the order.
§ 5815 (g) A microbusiness licensee subject to a temporary suspension may continue to cultivate cannabis at the licensed premises only as prescribed by the Bureau in the order. If the order permits the cannabis to be harvested, the licensee shall place the harvested cannabis into separate batches.
§ 5815 (h) The emergency decision and order for temporary, interim relief shall be issued in accordance with the following procedures:
(1) The Bureau shall give notice of the emergency decision and order and an opportunity to be heard to the licensee prior to the issuance, or effective date, of the emergency decision and order, if practicable.
(2) Notice and hearing under this section may be oral or written and may be provided by telephone, personal service, mail, facsimile transmission, electronic mail, or other electronic means, as the circumstances permit.
(3) Notice may be given to the licensee, any person meeting the definition of owner for the license, or to the manager or other personnel at the licensed premises.
(4) Upon receipt of the notice, the licensee may request a hearing within three (3) business days by submitting a written request for hearing to the Bureau through electronic mail, facsimile transmission, or other written means. The hearing shall commence within five (5) business days of receipt of the written request for hearing, unless a later time is agreed upon by the Bureau and
the licensee.
(5) The hearing may be conducted in the same manner as an informal conference under section 5803 of this division; however, the timeframes provided in section 5803 shall not apply to a hearing under this section. Pre-hearing discovery or cross-examination of witnesses is not required under this section.
(6) The emergency decision and order shall be affirmed, modified, or set aside as determined appropriate by the Bureau within five (5) business days of the hearing.
§ 5815 (i) Within ten (10) calendar days of the issuance or effective date of the emergency decision and order for temporary, interim relief, the Bureau shall commence adjudicative proceedings in accordance with Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code to resolve the underlying issues giving rise to the temporary, interim relief, notwithstanding the pendency of proceedings for judicial review of the emergency decision as provided in subsection (k).
§ 5815 (j) After formal proceedings pursuant to subsection (i) of this section are held, a licensee aggrieved by a final decision of the Bureau may appeal the decision to the Cannabis Control Appeals Panel pursuant to Section 26043 of the Act.
§ 5815 (k) Notwithstanding administrative proceedings commenced pursuant to subsection (i), the licensee may obtain judicial review of the emergency decision and order pursuant to section 1094.5 of the Code of Civil Procedure in the manner provided in Section 11460.80 of the Government Code without exhaustion of administrative remedies.
§ 5815 (l) The Bureau’s authority provided by this section may be used in addition to any civil, criminal, or other administrative remedies available to the Bureau.
Authority: Section 26013, Business and Professions Code.
Reference: Section 26012, Business and Professions Code; and Sections 11460.10, 11460.20, 11460.30, 11460.40, 11460.50, 11460.60, 11460.70 and 11460.80, Government Code.
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