Section 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: Quantitative methods | 4 levels: low, medium and high 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. (1) The licensed laboratory shall include and address the following criteria to validate test methods for chemical analyses of samples:(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 1/x.(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(ii) Each calibration curve must include an Initial Calibration Verification (ICV). The percent recovery must be between 70% to 130%.(E) Sensitivity and selectivity;(F) Limit of detection and limit of quantitation;(2) 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. (A) Cannabinoids, if available;(C) Microbial impurities;(F) Residual solvents and processing chemicals; and(G) Terpenoids, if available.(d) The licensed 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).(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 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.Cal. Code Regs. Tit. 4, § 15713
1. Change without regulatory effect renumbering and amending former title 16, section 5713 to new title 4, section 15713 filed 7-14-2021 pursuant to section 100, title 1, California Code of Regulations (Register 2021, No. 29). For prior history of title 16, division 42, see Register 2019, No. 3.
2. Amendment of subsections (a)-(c)(1), (c)(2), (d) and (d)(8) 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 of subsections (a)-(c)(1), (c)(2), (d) and (d)(8) 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 subsections (d)(6) and (d)(8), 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 26012, 26100, 26104 and 26110, Business and Professions Code.
1. Change without regulatory effect renumbering and amending former title 16, section 5713 to new title 4, section 15713 filed 7-14-2021 pursuant to section 100, title 1, California Code of Regulations (Register 2021, No. 29). For prior history of title 16, division 42, see Register 2019, No. 3.
2. Amendment of subsections (a)-(c)(1), (c)(2), (d) and (d)(8) 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 of subsections (a)-(c)(1), (c)(2), (d) and (d)(8) 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 subsections (d)(6) and (d)(8), 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).