§15711. Laboratory Analyses Standard Operating Procedures.
(a) The licensed laboratory shall develop, implement, and maintain written standard operating procedures (SOP) for sample preparation and each required test method. The licensed laboratory shall use and submit to the Department the following forms which are incorporated by reference:
- Sample Preparation – Standard Operating Procedures, Form DCC-LIC-022 (Amended 2/22), which is incorporated herein by reference; and
- Test Methods – Standard Operating Procedures, Form DCC-LIC-023 (Amended 2/22), which is incorporated herein by reference.
(b) The licensed laboratory shall keep each SOP at the licensed laboratory premises and ensure that each SOP is accessible to laboratory employees during operating hours.
(c) The licensed laboratory shall make each SOP available for inspection by the Department 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, 26102, 26104 and 26110, Business and Professions Code.
§15712. Test Methods.
(a) The laboratory shall develop, implement, and validate test methods for the analyses of samples as required under this division.
(b) To the extent practicable, the laboratory test methods shall comport with the following guidelines:
- US Food and Drug Administration’s Bacterial Analytical Manual, 2016;
- AOAC International’s Official Methods of Analysis for Contaminant Testing of AOAC International, 20th Edition, 2016; and
- United States Pharmacopeia and the National Formulary’s Methods of Analysis for Contaminant Testing, 2016.
Authority: Section 26013, Business and Professions Code.
Reference: Sections 26100, 26102, 26104 and 26110, Business and Professions Code.
§15712.1. Cannabinoid Test Method for Dried Flower, Including Non-Infused Pre- Rolls.
(a) Notwithstanding section 15712, a licensed laboratory shall utilize the cannabinoid test method required by this section and shall not utilize any other cannabinoid test method for the purpose of regulatory compliance testing and reporting results for dried flower, including non-infused pre-rolls. A licensed laboratory is not required to use the cannabinoid test method required by this section for cannabis products, including infused pre-rolls.
(b) The licensed laboratory shall use Standard Operating Procedures: Determination of Cannabinoids Concentration by High Performance Liquid Chromatography (HPLC) for Dried Flower, including Non-Infused Pre-Rolls (New 4/10/2023), which is incorporated by reference herein, to perform the cannabinoid testing required by section 15724.
(c) The cannabinoid test method identified in subsection (b) shall not be altered by the licensed laboratory.
(d) Notwithstanding the requirements of section 15724(a), the licensed laboratory shall analyze the sample size of the representative sample as specified in the cannabinoid test method identified in subsection (b).
(e) Prior to using the cannabinoid test method identified in subsection (b), the licensed laboratory shall perform a method verification of the cannabinoid test method, in accordance with section 15712.2, to demonstrate that the laboratory is capable of meeting the cannabinoid test method’s performance specifications.
(f) The licensed laboratory is not required to provide the Department with a validation report of the cannabinoid test method pursuant to sections 15702(c)(1) and 15713(d) for the cannabinoid test method identified in subsection (b).
(g) The licensed laboratory shall provide the Department with its standard operating procedures implementing the cannabinoid test method identified in subsection (b) in accordance with the requirements of sections 15702(b) and 15711(a). The standard operating procedures shall be submitted with the verification report required by section 15712.2 prior to use of the cannabinoid test method for regulatory compliance testing.
(h) The licensed laboratory shall commence utilizing the cannabinoid test method identified in subsection (b) no later than January 1, 2024.
(i) The licensed laboratory may test for additional cannabinoid analytes beyond those specified in section IV(A) and in additional matrices beyond those covered in the cannabinoid test method identified in subsection (b). The licensed laboratory shall provide a method validation for additional cannabinoid analytes and additional matrices in accordance with section 15713.
Authority: Sections 26013 and 26100, Business and Professions Code.
Reference: Section 26100, Business and Professions Code.
§15712.2. Verification of Cannabinoid Test Method for Dried Flower, Including Non- Infused Pre-Rolls.
(a) Prior to using the cannabinoid test method identified in section 15712.1(b) for regulatory compliance testing, each licensed laboratory shall perform a method verification of the cannabinoid test method in their own laboratory to demonstrate that the laboratory is capable of meeting the cannabinoid test method’s performance specifications.
(b) For purposes of this chapter, “method verification” means the process of demonstrating that a laboratory is capable of replicating a validated test method with an acceptable level of performance.
(c) For purposes of this chapter, “reagent blank” means reagents that are used in the procedure taken through the entire method and which are added in the same volumes as used in the sample preparation. A reagent blank is analyzed in the same manner as the representative sample.
(d) To complete the method verification of the cannabinoid test method identified in section 15712.1(b), the laboratory shall address the criteria listed in the following table:
| Criteria | Number Required |
| Reagent blanks | ≥1 |
| Method blanks | ≥1 |
| Spike concentration levels | ≥2 |
| Spike replicates | ≥3 |
(e) As part of the method verification:
- The licensed laboratory shall calculate the Limit of Detection (LOD) and Limit of Quantification (LOQ) for all analytes in accordance with section 15731; and
- The licensed laboratory shall evaluate the linear dynamic range for all analytes to ensure they meet the needs for the cannabinoid test method.
(f) The licensed laboratory shall generate a verification report for each cannabinoid test method used. Each verification report shall include the following information:
- Instrument calibration data;
- Raw data, including instrument raw data;
- Cannabis reference materials or certified reference material results;
- Data and calculations pertaining to LOD and LOQ determinations; and
- Laboratory Quality Control report, as described in section 15730(j).
(g) The supervisory or management laboratory employee shall review, approve, sign, and date the verification report for each cannabinoid test method used.
(h) The licensed laboratory shall provide the Department with the verification report demonstrating verification of the cannabinoid test method prior to use of the cannabinoid test method for regulatory compliance.
Authority: Sections 26013 and 26100, Business and Professions Code.
Reference: Section 26100, Business and Professions Code.
§15713. Validation of Test Methods.
(a) The licensed laboratory may use a nonstandard, amplified, or modified test method or a method that is designed or developed by the licensed laboratory to validate the methods for analyses of samples.
(b) The licensed 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 licensed laboratory shall include and address the criteria listed in the following table when validating test methods for microbial analyses of samples.
| Criteria | Requirement |
| Number of target organisms; inclusivity | 5 |
| Number of non-target organisms; exclusivity | 5 |
| Number of analyte levels per matrix: Qualitative methods | 3 levels: high and low inoculum levels and 1 uninoculated level |
| Number of analyte levels per matrix: | 4 levels: low, medium and high |
| Criteria | Requirement |
| Quantitative methods | inoculum levels and 1 uninoculated level |
| Replicates per food at each level tested | 2 or more replicates per level |
(c) The licensed 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.
- The licensed laboratory shall include and address the following criteria to validate test methods for chemical analyses of samples:
- Accuracy;
- Precision;
- Linearity and range;
- The Coefficient of Determination (r2) for all calibration curves shall be greater than or equal to 0.99.
- Linear regression or quadratic regression shall only be used for calibration curves. Curves shall not be weighted at all or only weighted at ⅟x.
- LOQ for analytes tested shall be within the range of the calibration curve.
- Calibration standard;
- For calibration curves, there shall be a minimum of five calibration standards, not including zero; and
- Each calibration curve must include an Initial Calibration Verification (ICV). The percent recovery must be between 70% to 130%.
- Sensitivity and selectivity;
- Limit of detection and limit of quantitation;
- Recovery;
- Reproducibility; and
- Robustness.
- The licensed laboratory shall use certified reference materials to validate the following chemical analyses. The test method used for analysis is valid if the percent recovery of the certified reference material is between 80% to 120% for all required analytes.
- Cannabinoids, if available;
- Heavy metals;
- Microbial impurities;
- Mycotoxins;
- Residual pesticides;
- Residual solvents and processing chemicals; and
- Terpenoids, if available.
(d) The licensed laboratory shall generate a validation report for each test method. Each validation report shall include the following information:
- Instrument calibration data, if any;
- Raw data, including instrument raw data, for each test method, if any;
- Cannabis reference materials or certified reference material results;
- Data and calculations pertaining to LOD and LOQ determinations, if any;
- LQC report, as described in this chapter, for the validation of each method; and
- Worksheets, forms, pictures, or copies of laboratory notebook pages and any other documentation necessary to meet the requirements described in subsections (b) and (c).
- The supervisory or management laboratory employee shall review, approve, sign, and date the validation report for each test method.
- Upon new test methods or altered test methods being used in the laboratory, the new validation report shall be submitted to the Department within 5 business days, accompanied by the Licensee Notification and Request Form, Notifications and Requests Regarding Testing Laboratories, DCC-LIC-029 (New 2/22), which is incorporated herein by reference.
Authority: Section 26013, Business and Professions Code.
Reference: Sections 26012, 26100, 26104 and 26110, Business and Professions Code.