All testing laboratory-specific 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.
(a) The laboratory shall participate in a proficiency testing program (“PT program”) provided by an organization that operates in conformance with the requirements of ISO/IEC 17043, at least once every six months after receiving ISO/IEC 17025 accreditation. (b) The laboratory shall participate in the PT program by following the laboratory’s existing SOPs for testing cannabis and cannabis products. (c) The laboratory shall rotate the PT program among the analytical methods in the laboratory’s scope of accreditation and among the employees who perform the test methods. (d) Laboratory employees who participate in a PT program shall sign the corresponding analytical reports or attestation statements to certify that the PT program was conducted in the same manner as the laboratory tests of cannabis and cannabis products. (e) A supervisory or management laboratory employee shall review and verify the accuracy of results reported for all PT program samples analyzed. (f) The laboratory shall provide PT program results to the Bureau within 3 business days after the laboratory receives notification of their test results from the PT program provider. Authority: Section 26013, Business and Professions Code. Reference: Sections 26100 and 26110, Business and Professions Code.
(a) The laboratory shall use LQC samples in the performance of each analysis according to the following specifications. (b) The laboratory shall analyze LQC samples in the same manner as the laboratory analyzes cannabis and cannabis product samples. (c) The laboratory shall use negative and positive controls for microbial testing. (d) The laboratory shall prepare and analyze at least one of each of the following LQC samples for each analytical batch within each set of 20 samples for the following LQC samples: (1) Method blank; (2) Continuing calibration verification (CCV); (3) Laboratory replicate sample; and (4) Matrix spike sample or matrix spike duplicate sample. (e) If the result of the 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.
(f) The laboratory shall generate a LQC sample report for each analytical batch that includes LQC parameters, measurements, analysis date, and matrix. Authority: Section 26013, Business and Professions Code. Reference: Sections 26100, 26104 and 26110, Business and Professions Code.
(a) A harvest batch or cannabis product batch that has been additionally processed after a failed testing must be retested and successfully pass all the analyses required under this chapter. (b) A harvest batch or cannabis product batch that failed testing only because of nonconformance with the labeled content may be relabeled so that the batch conforms with the labeled content. (c) A harvest batch or cannabis product batch that is relabeled by the distributor so that the batch conforms with the labeled content shall not be additionally processed or additionally analyzed. (d) A harvest batch or cannabis product batch may only be remediated twice. If the batch fails after the second remediation attempt and the second retesting, the entire batch shall not be released for retail sale. (e) Within 1 business day of completing the required analyses of a sample obtained from a remediated harvest batch or remediated cannabis product batch, the laboratory shall enter the COA information into the track and trace system. Authority: Section 26013, Business and Professions Code. Reference: Sections 26100, 26104 and 26110, Business and Professions Code.
(a) The laboratory shall analyze a sample of cannabis or cannabis product to determine whether the terpenoid profile of the sample conforms to the labeled content of terpenoids. (b) The laboratory shall report the result of the terpenoid testing on the COA both as a percentage and in milligrams per gram (mg/g) and indicate “pass” or “fail” on the COA. (c) A sample shall be deemed to have passed the terpenoid testing if the concentration of terpenoids does not exceed the labeled content of total terpenoids, plus or minus 10 percent. (d) If a sample fails terpenoid testing, the batch from which the sample was collected fails terpenoid 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.
(a) The laboratory shall analyze a sample of cannabis or cannabis product to determine whether the cannabinoid profile of the sample conforms to the labeled content of each cannabinoid such as THC; THCA; CBD; CBDA; CBG; and CBN. (b) The laboratory shall report the result of the cannabinoid testing on the COA both as a percentage and in milligrams per gram (mg/g) dry-weight using the following equation and indicate “pass” or “fail” on the COA: Dry-weight percent cannabinoid = wet-weight percent cannabinoid / (1 − percent moisture / 100) (c) If the labeled content of any one cannabinoid is expressed as a total concentration of the cannabinoid, the laboratory shall calculate the total cannabinoid concentration as follows: Total cannabinoid concentration (mg/g) = (cannabinoid acid form concentration (mg/g) x 0.877) + cannabinoid concentration (mg/g) (d) A sample shall be deemed to have passed the cannabinoid testing if the concentration of any one cannabinoid does not exceed the labeled content of the cannabinoid, plus or minus 10%. (e) 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.
(a) The laboratory shall analyze a sample of cannabis or cannabis product to determine whether foreign material is present. (b) The laboratory shall report the result of the foreign material test by indicating “pass” or “fail” on the COA. (c) The laboratory shall perform foreign material testing on the total representative sample prior to sample homogenization. (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 cannabis sample, and (2) Examine the exterior of the cannabis product sample. (e) A 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 rodent 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. (f) If a 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.
(a) The laboratory shall analyze a sample of cannabis or cannabis product to determine whether mycotoxins are present. (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. (c) A 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. (d) If a 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
(a) The laboratory shall analyze a sample of cannabis or cannabis product to determine whether microbial impurities are present. (b) The laboratory shall report the result of the microbial impurities testing by indicating “pass” or “fail” on the COA. (c) A sample of inhalable cannabis or inhalable cannabis product 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. (d) A sample of other cannabis or cannabis product shall be deemed to have passed the microbial impurities testing if both the following: (1) Shiga toxin–producing Escherichia coli is not detected in 1 gram, and (2) Salmonella spp. is not detected in 1 gram. (e) If a 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.
(a) The laboratory shall analyze a sample of cannabis product to determine whether residual solvents or processing chemicals are present. (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.
(c) The laboratory shall establish a limit of quantification (LOQ) of 1.0 µg/g or lower for all Category I Residual Solvents or Processing Chemicals. (d) The sample shall be deemed to have passed the residual solvents and processing chemicals testing if both of the following conditions are met: (1) The presence of any residual solvent or processing chemical listed in the following tables in Category I is not detected, and (2) The presence of any residual solvent or processing chemical listed in the following tables in Category II does not exceed the indicated action levels.
(d) If a 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.
