Cal. Code Regs. tit. 4 § 15712.2

Current through Register 2024 Notice Reg. No. 45, November 8, 2024
Section 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:

CriteriaNumber Required
Reagent blanks>=1
Method blanks>=1
Spike concentration levels>=2
Spike replicates>=3

(e) As part of the method verification:
(1) The licensed laboratory shall calculate the Limit of Detection (LOD) and Limit of Quantification (LOQ) for all analytes in accordance with section 15731; and
(2) 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:
(1) Instrument calibration data;
(2) Raw data, including instrument raw data;
(3) Cannabis reference materials or certified reference material results;
(4) Data and calculations pertaining to LOD and LOQ determinations; and
(5) 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.

Cal. Code Regs. Tit. 4, § 15712.2

1. New section filed 7-28-2023; operative 10-1-2023 (Register 2023, No. 30).

Note: Authority cited: Sections 26013 and 26100, Business and Professions Code. Reference: Section 26100, Business and Professions Code.

1. New section filed 7-28-2023; operative 10/1/2023 (Register 2023, No. 30).