(a) The Bureau may issue citations containing orders of abatement and fines against a licensee, or an unlicensed person, for any acts or omissions which are in violation of any provision of the Act or any regulation adopted pursuant thereto. (b) The Bureau may issue a citation under this section to a licensee for a violation of a term or condition contained in a decision placing that licensee on probation. (c) Each citation: (1) Shall be in writing. (2) Shall describe with particularity the nature of the violation, including a reference to the law or regulation determined to have been violated. (3) May contain an assessment of an administrative fine of up to $5,000, and/or an order of abatement fixing a reasonable time for abatement of the violation; (4) Shall be served personally or by certified mail; and (5) Shall inform the licensee or person that he or she may request an informal conference, or contest the citation, or both, pursuant to section 5803. (d) Failure to pay a fine within 30 calendar days of the date of assessment, unless the citation is being contested, may result in further action being taken by the Bureau including, but not limited to, suspension or revocation of a license. If a citation is not appealed and the fine is not paid, the full amount of the assessed fine shall be added to the fee for renewal of the license. A license shall not be renewed without the payment of the renewal fee and fine. (e) The amount of any fine to be levied by the Bureau shall take into consideration the factors listed in subdivision (b)(3) of Section 125.9 of the Business and Professions Code. (f) Nothing in this section shall be deemed to prevent the Bureau from filing an accusation to suspend or revoke a license where grounds for such suspension or revocation exist. Authority: Sections 125.9 and 26013, Business and Professions Code. Reference: Sections 125.9, 148, 149 and 26012, Business and Professions Code.
BUREAU OF CANNABIS CONTROL;ENFORCEMENT § 5800. Right of Access
(a) The Bureau, and its authorized representatives, shall have full and immediate access to inspect and: (1) Enter onto any premises licensed by the Bureau. (2) Test any vehicle or equipment possessed by, in control of, or used by a licensee or their agents and employees for the purpose of conducting commercial cannabis activity. (3) Test any cannabis goods or cannabis-related materials or products possessed by, in control of, or used by a licensee or their agents and employees for the purpose of conducting commercial cannabis activity. (4) Copy any materials, books, or records of any licensee or their agents and employees. (b) Failure to cooperate with and participate in any Bureau investigation pending against the licensee may result in a licensing violation subject to discipline. This subsection shall not be construed to deprive a licensee of any privilege guaranteed by the Fifth Amendment to the Constitution of the United States, or any other constitutional or statutory privileges. This subsection shall not be construed to require a licensee to cooperate with a request that would require the licensee to waive any constitutional or statutory privilege or to comply with a request for information or other matters within an unreasonable period of time in light of the time constraints of the licensee’s business. Any constitutional or statutory privilege exercised by the licensee shall not be used against the licensee in a regulatory or disciplinary proceeding against the licensee. (c) The Bureau, and its authorized representatives, shall have the rights of immediate access under subsection (a), during any inspection, investigation, review, or audit, or as otherwise allowed by law. (d) Prior notice of an inspection, investigation, review, or audit is not required. (e) Any inspection, investigation, review, or audit of a licensed premises shall be conducted anytime the licensee is exercising privileges under the license, or as otherwise agreed to by the Bureau and the licensee or its agents, employees, or representatives. (f) If the premises is not accessible because access is only available by going through another licensed premises and the licensee occupying the other premises denies the Bureau access, the licensees shall both be held responsible and subject to discipline. Authority: Section 26013, Business and Professions Code. Reference: Sections 26012, 26015, and 26160, Business and Professions Code; and Section 11181, Government Code.
BUREAU OF CANNABIS CONTROL;§ 5739. Records
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.
BUREAU OF CANNABIS CONTROL;§ 5738. Analyst and Sampler Qualifications
(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. (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.
BUREAU OF CANNABIS CONTROL;§ 5737. Supervisor or Management Responsibilities and Qualifications
(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. (b) To be considered qualified, the supervisor or management employee must have earned, 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; or (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. Authority: Section 26013, Business and Professions Code. Reference: Sections 26102 and 26104, Business and Professions Code.
BUREAU OF CANNABIS CONTROL;§ 5735. Internal audit
(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. (b) The internal audit must include all of the components required by the ISO/IEC 17025 internal-audit standards. (c) Within 3 business days of completing the internal audit, the laboratory shall submit the results of the internal audit to the Bureau. Authority: Section 26013, Business and Professions Code. Reference: Sections 26100 and 26104, Business and Professions Code.
BUREAU OF CANNABIS CONTROL; § 5733. Required Proficiency Testing
(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.
BUREAU OF CANNABIS CONTROL;§ 5732. Data Package
(a) The laboratory shall generate a data package for each batch of samples that the laboratory analyzes. At a minimum, the data package shall contain the following: (1) The name and address of the laboratory that performed the analytical procedures; (2) The names, functions, and signatures of the laboratory employees that performed the sample preparation, analyses, and reviewed and approved the data; (3) All batch sample results and batch LQC sample results; (4) Raw data, including instrument raw data, for each sample, if any; (5) Instrument test method with parameters, if any; (6) Instrument tune report, if any; (7) Instrument calibration data, if any; (8) LQC sample report with worksheets, forms, or copies of laboratory notebook pages containing pertinent information related to the identification and traceability of all reagents, reference materials, and standards used for analysis; (9) Analytical batch sample sequence, if any; (10) The field sample log and the COC form; and (11) The COA created as required under this chapter. (b) After the data package is compiled, the supervisory or management laboratory employee shall do the following: (1) Review the analytical results for technical correctness and completeness; (2) Verify that the results of each analysis carried out by the laboratory are reported accurately, clearly, unambiguously, and objectively; and (3) Approve the laboratory results by signing and dating the data package prior to release of the data by the laboratory. (c) The data package shall be kept for a minimum of 7 years and shall be made available upon request by the Bureau. Authority: Section 26013, Business and Professions Code. Reference: Sections 26100, 26104, 26110 and 26160, Business and Professions Code.
BUREAU OF CANNABIS CONTROL;§ 5731. Limits of Detection (LOD) and Limits of Quantitation (LOQ) for Quantitative Analyses
(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 blank samples; or (3) A method published by the United States Food and Drug Administration (USFDA) or the United States Environmental Protection Agency (USEPA). (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 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.
BUREAU OF CANNABIS CONTROL;§ 5730. Laboratory Quality Control (LQC) Sample
(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.