RPD = │ (representative sample measurement – replicate sample measurement) / ([representative sample measurement + replicate sample measurement] / 2) × 100%
(ccc) “Relative standard deviation” (RSD) means the standard deviation expressed as a percentage of the means recovery. RSD is calculated using the following equation:
RSD = (s / x) × 100%; where s = standard deviation and x = mean (ddd) “Representative” means a small quantity of the batch whose characteristics represent, as accurately as possible, the entire batch, thus allowing the results to be generalized.
(eee) “Representative sample” means a sample that is comprised of several sample increments of cannabis or cannabis products that are collected from a batch for testing. (fff) “Requester” means the person who submits a request to the laboratory for testing of cannabis or cannabis products from an entity licensed under the Act. (ggg) “Reserve sample” means any portion of a representative sample that was not used in the testing process.
(hhh) “Sample” means a representative part of, or a single item from, a batch which is comprised of several sample increments.
(jjj) “Sample increment” means a portion of a batch that, together with other increments, makes up the sample.
(kkk) “Sampler” means the laboratory employee responsible for obtaining samples of cannabis or cannabis products from a licensed distributor or licensed microbusiness authorized to engage in distribution.
(lll) “Sanitize” means to sterilize, disinfect, or make hygienic. (mmm) “Scope of accreditation” means the tests or types of tests performed, materials or products tested, and the methods used for testing cannabis or cannabis products for which the accreditation has been granted.
(nnn) “Standard operating procedure” (SOP) means a written document that provides detailed instructions for the performance of all aspects of an analysis, operation, or action.
(ooo) “Target organism” means an organism that is being tested for in an analytical procedure or test method.
(ppp) “THCA” means tetrahydrocannabinolic acid, CAS number 23978-85-0. (qqq) “Total CBD” means the sum of CBD and CBDA. Total CBD is calculated using the following equation:
Total CBD concentration (mg/g) = (CBDA concentration (mg/g) x 0.877) + CBD Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 118 of 216 concentration (mg/g)
(rrr) “Total THC” means the sum of THC and THCA. Total THC is calculated using the following equation:
Total THC concentration (mg/g) = (THCA concentration (mg/g) x 0.877) + THC concentration (mg/g)
(sss) “Validation” means the confirmation by examination and objective evidence that the requirements for a specific intended use or analytical method are fulfilled. (ttt) “Water activity” means the measure of the quantity of water in a product that is available and therefore capable of supporting bacteria, yeasts, and fungi and which is reported in units Aw.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26013 and 26100, Business and Professions Code.
Article 2. Laboratory License
§15701. General Laboratory License Requirements.
(a) A licensed laboratory shall maintain ISO/IEC 17025 accreditation for the testing of the following:
(1) Cannabinoids;
(2) Heavy metals;
(3) Microbial impurities;
(4) Mycotoxins;
(5) Residual pesticides;
(6) Residual solvents and processing chemicals; and
(7) If tested, terpenoids.
(b) Each testing laboratory licensed premises shall have ISO/IEC 17025 accreditation. (c) A licensed laboratory shall retain, and make available to the Department upon request, all records associated with the licensee’s ISO/IEC 17025 certificate of accreditation.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26012 and 26100, Business and Professions Code.
§15702. Laboratory License Application.
In addition to the information required in section 15002 of this division, an application for a testing laboratory license includes the following:
(a) A valid certificate of accreditation, issued by an accreditation body, that attests to the laboratory’s competence to perform testing, including all the required analytes for the following test methods:
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 119 of 216 (1) Cannabinoids;
(2) Heavy metals;
(3) Microbial impurities;
(4) Mycotoxins;
(5) Residual pesticides;
(6) Residual solvents and processing chemicals; and
(7) If tested, terpenoids.
(b) Standard operating procedures for the following testing methods:
(1) Cannabinoids;
(2) Foreign material;
(3) Heavy metals;
(4) Microbial impurities;
(5) Moisture content and water activity;
(6) Mycotoxins;
(7) Residual pesticides;
(8) Residual solvents and processing chemicals; and
(9) If tested, terpenoids.
(c) Method validation reports for the following testing methods:
(1) Cannabinoids;
(2) Heavy metals;
(3) Microbial impurities;
(4) Water activity;
(5) Mycotoxins;
(6) Residual pesticides;
(7) Residual solvents; and processing chemicals; and
(8) If tested, terpenoids.
(d) Standard operating procedures for the sampling of cannabis or cannabis products.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26012, 26050, 26055, 26102 and 26104, Business and Professions Code. §15703. Interim Testing Laboratory License.
(a) An applicant may apply for an interim license prior to receiving ISO/IEC 17025 accreditation provided that the commercial cannabis business meets all other licensure requirements for a testing laboratory and submits to the Department an application in Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 120 of 216 compliance with section 15002 of this division and an attestation that the commercial cannabis business has or intends to seek ISO/IEC 17025 accreditation for all testing methods required by this division.
(b) An interim testing laboratory license shall be valid for 12 months. The annual license fee for an interim license shall be determined pursuant to the requirements in section 15014 of this division for determining the annual license fee for a testing laboratory license.
(c) To timely renew an interim license, a completed license renewal form and the annual renewal license fee pursuant to section 15014 of this division shall be received by the Department from the licensee no earlier than 60 calendar days before the expiration of the license and no later than 5:00 p.m. Pacific Time on the last business day before the expiration of the license if the renewal form is submitted to the Department at its office(s), or no later than 11:59 p.m. on the last business day before the expiration of the license if the renewal form is submitted to the Department through its electronic licensing system.
Failure to receive a notice for license renewal does not relieve a licensee of the obligation to renew an interim license as required.
(d) In the event the license is not renewed prior to the expiration date, the licensee must not test any commercial cannabis or cannabis products until the license is renewed. (e) A licensee may submit a license renewal form up to 30 calendar days after the license expires. Any late renewal form will be subject to a late fee equal to 50 percent of the applicable licensing fees required by subsection (c) of this section. (f) The license renewal application shall contain the following:
(1) The name of the licensee. For licensees who are individuals, the applicant shall provide both the first and last name of the individual. For licensees who are business entities, the licensee shall provide the legal business name of the commercial cannabis business;
(2) The license number and expiration date;
(3) The licensee’s address of record and licensed premises address; and (4) An attestation that all information provided to the Department in the original application under section 15002 of this division or subsequent notification under sections 15023 and 15024 of this division is accurate and current. (g) The Department may renew an interim license for an initial renewal period of 12 months.
(h) After one renewal, the Department may renew the interim license for additional 12- month periods if the licensee has submitted an application for the ISO/IEC 17025 accreditation. In addition to the information required for a renewal form pursuant to subsection (f) of this section, any renewal request pursuant to this section shall also include an attestation that the licensee’s application for each ISO/IEC 17025 is pending with the accrediting body, the name of the accrediting body, and the date the application was submitted to the accrediting body.
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 121 of 216 (i) The licensee shall notify the Department if the application for each ISO/IEC 17025 accreditation is granted or denied within 1 business day of receiving the decision from the accrediting body. The licensee shall submit to the Department the information required, on the Licensee Notification and Request Form, Notifications and Requests Regarding Testing Laboratories, DCC-LIC-029 (New 9/21), which is incorporated herein by reference. If the accrediting body grants or denies the licensee’s application for any ISO/IEC 17025 accreditation before the expiration of the interim license, the Department may terminate the interim license at that time.
(j) The Department may revoke an interim license at any time.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26012, 26031, 26050 and 26102, Business and Professions Code.
Article 3. Sampling Cannabis and Cannabis Products
§15704. Sampling Standard Operating Procedures.
(a) The licensed laboratory shall develop and implement a sampling standard operating procedure (SOP) that describes the laboratory’s method for obtaining representative samples of cannabis or cannabis products. The licensed laboratory shall use and submit to the Department Sampling – Standard Operating Procedures, DCC-LIC-021 (Amended 9/21), which is incorporated herein by reference.
(b) The licensed laboratory shall retain a copy of the sampling SOP on the licensed laboratory premises and ensure that the sampling SOP is accessible to the sampler during sampling.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26100, 26102, 26104 and 26110, Business and Professions Code.
§15705. General Sampling Requirements.
(a) The licensed laboratory that obtains a representative sample from a licensed distributor or licensed microbusiness shall perform all the required testing at one licensed laboratory premises.
(b) The licensed laboratory may obtain and analyze samples only from cannabis products batches in final form as required by Business and Professions Code section 26100.
(c) The licensed laboratory sampler shall collect a representative sample from each batch following the procedures specified in the laboratory’s sampling standard operating procedure(s).
(d) The licensed laboratory shall ensure that the sample is transported and subsequently stored at the licensed laboratory premises in a manner that prevents degradation, contamination, commingling, and tampering. If the cannabis or cannabis products specify on the label how the cannabis or cannabis products shall be stored, the laboratory shall store the sample as indicated on the label.
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 122 of 216 (e) The licensed laboratory shall complete a chain of custody form for each sample that the laboratory collects and analyzes.
(f) Once a representative sample has been obtained for regulatory compliance testing, the licensed laboratory that obtained the sample must complete the regulatory compliance testing.
(g) If a licensed laboratory is unable to competently complete the regulatory compliance testing after sampling and before a COA is issued, the licensed distributor or microbusiness authorized to engage in distribution who arranged for the testing of the batch may request approval from the Department to have the impacted batch re-sampled and tested by another licensed laboratory.
(1) The request shall be made in writing via email to [email protected] and shall include all of the following:
(A) The name and license number of the distributor;
(B) The batch numbers;
(C) The type and quantity of cannabisor cannabis products; (D) The name and license number of the laboratory that took the initial sample and is not able to competently complete the regulatory compliance testing; (E) The name and license number of the laboratory proposed to re-sample and complete the regulatory compliance testing for the batch; and
(F) The reason why the laboratory that initially took the sample cannot competently complete the regulatory compliance testing.
(2) The Department will review the request and determine if the licensed laboratory that initially took the sample is unable to competently complete the regulatory compliance testing. If the Department determines that the licensed laboratory is unable to competently complete the regulatory compliance testing, the Department, in its discretion, may approve the request in whole or part and set conditions for the resampling and testing. (3) No re-sampling of any batch shall occur prior to the licensed distributor or licensed microbusiness authorized to engaged in distribution receiving written approval from the Department.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26100, 26104 and 26110, Business and Professions Code.
§15706. Chain of Custody (COC).
(a) The licensed laboratory shall develop and implement a COC protocol to ensure accurate documentation is recorded for the transport, handling, storage, and destruction of samples.
(b) The COC protocol shall require the use of a COC form. The sampler shall use a COC to record the following information for each sampled batch:
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 123 of 216 (1) Laboratory’s name, licensed premises address, and license number; (2) Date and time sampling started and ended;
(3) Licensed distributor or licensed microbusiness’ name, licensed premises address, and license number;
(4) Licensed cultivator’s, licensed manufacturer’s, or licensed microbusiness’ name, licensed premises address, and license number;
(5) Batch number of the batch from which the representative sample was obtained and assigned unique sample identifier;
(6) Sample matrix;
(7) Total batch size, by weight, or unit count;
(8) Total weight, or unit count of the representative sample; (9) Sampling conditions or problems encountered during the sampling process, if any; (10) Printed name and signature of the licensed distributor or licensed microbusiness’ authorized to engage in distribution employee; and
(11) Printed name and signature of the sampler.
(c) Each time a sample changes custody between licensees, is transported, or is destroyed, the date, time, and the names and signatures of persons involved in these activities shall be recorded on the COC form.
(d) Once the custody of the sample changes between licensees, the COC form for that change of custody may not be altered.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26100, 26102, 26104 and 26110, Business and Professions Code.
§15707. Harvest Batch Sampling.
(a) The sampler shall obtain a representative sample from each prepacked or unpacked harvest batch. The representative sample must weigh 0.35% of the total harvest batch weight.
(b) A sampler may collect a representative sample greater than 0.35% of the total harvest batch weight of a prepacked or unpacked harvest batch if necessary to perform the required testing or to ensure that the samples obtained are representative. (c) The prepacked or unpacked harvest batch from which a sample is obtained shall weigh no more than 50.0 pounds. Laboratory analyses of a sample collected from a harvest batch weighing more than 50.0 pounds shall be deemed invalid and the harvest batch from which the sample was obtained shall not be released for retail sale. (d) When the sampler obtains a representative sample from an unpacked harvest batch, the sampler shall do all the following:
(1) Collect the number of sample increments relative to the unpacked harvest batch size as listed in the following table;
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 124 of 216 (2) Obtain sample increments from random and varying locations of the unpacked harvest batch, both vertically and horizontally. To the extent practicable, the sample increments obtained from an unpacked harvest batch shall be of equal weight; and (3) To the extent practicable, collect an equal number of sample increments from each container if the unpacked harvest batch is stored in multiple containers.
Unpacked Harvest Batch Size (pounds) Number of Increments (per sample) ≤ 10.0 8
10.1 – 20.0 16
20.1 – 30.0 23
30.1 – 40.0 29
40.1 – 50.0 34
Authority: Section 26013, Business and Professions Code. Reference: Sections 26100, 26104 and 26110, Business and Professions Code.
§15708. Cannabis Product Batch and Pre-Roll Sampling.
(a) The sampler shall obtain a representative sample from each cannabis product batch or pre-roll batch.
(b) The sampler may collect a greater number of sample increments if necessary to perform the required testing or to ensure that the samples obtained are representative. (c) The cannabis product batch or pre-roll batch from which a representative sample is obtained shall contain no more than 150,000 units. Laboratory analyses of a sample collected from a cannabis product batch containing more than 150,000 units shall be deemed invalid and the cannabis product batch or pre-roll batch from which the representative sample was obtained shall not be released for retail sale. (d) The sampler shall obtain a representative sample of a cannabis product or pre-roll batch by collecting, at minimum, the number of sample increments relative to the batch size as listed in the following table. Each sample increment consists of 1 packaged unit.
Cannabis Product or Pre-roll Batch
Size (units)
Number of Sample Increments (per
sample)
≤ 50 2
51 – 150 3
151 – 500 5
501 – 1,200 8
1,201 – 3,200 13
3,201 – 10,000 20
10,001 – 35,000 32
35,001 – 150,000 50
Authority: Section 26013, Business and Professions Code. Reference: Sections 26100, 26104 and 26110, Business and Professions Code.
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 125 of 216 §15709. Laboratory Transportation of Cannabis and Cannabis Products Samples. (a) The following requirements apply when a licensed testing laboratory transports cannabis or cannabis products samples:
(1) While transporting cannabis or cannabis products samples, a licensed testing laboratory employee shall ensure the cannabis or cannabis products are not visible to the public. Cannabis or cannabis products shall be locked in a fully enclosed box, container, or cage that is secured to the inside of the vehicle or trailer. No portion of the enclosed box, container, or cage shall be comprised of any part of the body of the vehicle or trailer.
For the purposes of this section, the inside of the vehicle includes the trunk. (2) While left unattended, vehicles and trailers shall be locked and secured. (3) The licensed laboratory shall not leave a vehicle or trailer containing cannabis or cannabis products samples unattended in a residential area or parked overnight in a residential area.
(4) The licensed laboratory shall ensure that any vehicle or trailer transporting cannabis or cannabis products samples has an alarm system.
(5) The licensed laboratory shall ensure that packages or containers holding cannabis or cannabis products samples are neither tampered with nor opened during transport. (6) The licensed laboratory transporting cannabis or cannabis products samples shall only travel between licensees for whom the laboratory is conducting regulatory compliance testing or quality assurance testing. A laboratory shall not deviate from the travel requirements described in this section, except for necessary rest, fuel, or vehicle repair stops.
(7) The licensed laboratory may transport multiple cannabis or cannabis products samples obtained from multiple licensees at once.
(8) Vehicles or trailers transporting cannabis or cannabis products samples are subject to inspection by the Department at any licensed premises or during transport at any time. (9) No person under the age of 21 years old shall be in a vehicle or trailer transporting cannabis or cannabis products samples.
(10) Only an employee of the licensed laboratory or security personnel who meets the requirement of section 15045 of this division shall be in a vehicle while transporting cannabis or cannabis products samples.
(b) Upon request, the licensed laboratory shall provide the following required transport vehicle information to theDepartment:
(1) The certificate of ownership or registration card issued by the California Department of Motor Vehicles for each vehicle used to transport cannabis or cannabis products samples;
(2) The year, make, model, license plate number, and numerical Vehicle Identification Number (VIN) for each vehicle or trailer used to transport cannabis or cannabis products samples; and
(3) Proof of insurance for each vehicle used to transport cannabis or cannabis products Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 126 of 216 samples.
(c) The laboratory shall provide the Department with the information required by this section in writing for any new vehicle or trailer that will be used to transport cannabis or cannabis products samples prior to using the vehicle or trailer.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26100, 26102, 26104 and 26110, Business and Professions Code.
§15710. Laboratory Receipt of Samples Obtained from a Distributor or Microbusiness.
(a) The licensed laboratory may accept and analyze a sample from a licensed distributor or licensed microbusiness authorized to engage in distribution for the required testing under section 15714 of this division only if there is an accompanying COC form for the sample.
(b) The licensed laboratory employee who receives the sample shall date, print, and sign their name on the accompanying sample COC.
(c) The licensed laboratory shall not analyze a sample obtained from a licensed distributor or licensed microbusiness authorized to engage in distribution, and the batch from which the sample was obtained may not be released for retail sale, if any of the followingoccur:
(1) The sample is received at the laboratory without the requisite COC form; (2) The tamper-evident material is broken prior to the sample being received at the laboratory; or
(3) There is evidence of sample commingling, contamination, degradation, or a related occurrence rendering the sample unusable for analytical testing when the sample is received at the laboratory.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26100, 26104 and 26110, Business and Professions Code.
Article 4. Standard Operating Procedures
§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:
(1) Sample Preparation – Standard Operating Procedures, Form DCC-LIC-022 (Amended 9/21), which is incorporated herein by reference; and (2) Test Methods – Standard Operating Procedures, Form DCC-LIC-023 (Amended 9/21), 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.
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 127 of 216 (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:
(1) US Food and Drug Administration’s Bacterial Analytical Manual, 2016; (2) AOAC International’s Official Methods of Analysis for Contaminant Testing of AOAC International, 20th Edition, 2016; and
(3) 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.
§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 Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 128 of 216 (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:
(A) Accuracy;
(B) Precision;
(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 ⅟x. (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;
(G) Recovery;
(H) Reproducibility; and
(I) Robustness.
(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;
(B) Heavy metals;
(C) Microbial impurities;
(D) Mycotoxins;
(E) Residual pesticides;
(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:
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 129 of 216 (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) of this section.
(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 9/21), which is incorporated herein by reference.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26012, 26100, 26104 and 26110, Business and Professions Code.
Article 5. Laboratory Testing and Reporting
§15714. Required Testing.
(a) All sample increments collected must be homogenized prior to sample analyses, notwithstanding foreign material testing.
(b) The licensed laboratory shall test each representative sample for the following:
(1) Cannabinoids;
(2) Foreign material;
(3) Heavy metals;
(4) Microbial impurities;
(5) Mycotoxins;
(6) Moisture content and water activity;
(7) Residual pesticides;
(8) Residual solvents and processing chemicals; and
(9) If applicable, terpenoids.
(c) The licensed laboratory shall report the results of each analysis performed by the laboratory on the certificate of analysis.
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 130 of 216 (d) The licensed laboratory that obtained the representative sample shall complete all required testing for each representative sample for regulatory compliance testing.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26100, 26104 and 26110, Business and Professions Code.
§15717. Moisture Content and Water Activity Testing.
(a) The licensed laboratory shall analyze at minimum 0.5 grams of the representative sample of dried flower to determine the level of water activity and the percentage of moisture content.
(1) The dried flower sample, including pre-rolls, shall be deemed to have passed water activity testing if the water activity does not exceed 0.65 Aw. The laboratory shall report the result of the water activity test on the certificate of analysis (COA) and indicate “pass” or “fail” on the COA.
(2) The licensed laboratory shall report the result of the moisture content test on the COA as a percentage.
(b) The licensed laboratory shall analyze at least 0.5 grams of the representative sample of solid edible cannabis products to determine the level of water activity. A solid edible cannabis product shall be deemed to have passed water activity testing if the water activity does not exceed 0.85 Aw. The laboratory shall report the result of the water activity test on the COA and indicate “pass” or “fail” on the COA. (c) If the sample fails water activity testing, the batch from which the sample was collected fails water activity 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.
§15718. Residual Solvents and Processing Chemicals Testing. (a) The licensed laboratory shall analyze at minimum 0.25 grams of the representative sample of cannabis product or pre-rolls to determine whether residual solvents or processing chemicals are present.
(b) The licensed 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 sample shall be deemed to have passed the residual solvents and processing chemicals testing if the presence of any residual solvent or processing chemical listed in the following tables in Category I and Category II does not exceed the indicated action levels.
(1) Notwithstanding subsection (c), the limit for ethanol does not apply to cannabis products that are tinctures.
(2) Notwithstanding subsection (c), the limit for ethanol or isopropyl alcohol does not apply to cannabis products that are topical cannabis products.
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 131 of 216 Category I Residual Solvent or
Processing Chemical CAS No. Cannabis Product or Pre-Roll Action Level (µg/g) 1,2-Dichloroethane 107-06-2 1.0
Benzene 71-43-2 1.0
Chloroform 67-66-3 1.0
Ethylene oxide 75-21-8 1.0
Methylene chloride 75-09-2 1.0
Trichloroethylene 79-01-6 1.0
Category II Residual Solvent or
Processing Chemical
CAS No. Cannabis Product or Pre-roll
Action Level (µg/g)
Acetone 67-64-1 5000
Acetonitrile 75-05-8 410
Butane 106-97-8 5000
Ethanol 64-17-5 5000
Ethyl acetate 141-78-6 5000
Ethyl ether 60-29-7 5000
Heptane 142-82-5 5000
Hexane 110-54-3 290
Isopropyl alcohol 67-63-0 5000
Methanol 67-56-1 3000
Pentane 109-66-0 5000
Propane 74-98-6 5000
Toluene 108-88-3 890
Total xylenes (ortho-, meta-, para-) 1330-20-7 2170
(d) If the 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.
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 132 of 216 §15719. Residual Pesticides Testing.
(a) The licensed laboratory shall analyze at minimum 0.5 grams of the representative sample of cannabis and cannabis products to determine whether residual pesticides are present.
(b) The licensed laboratory shall report whether any Category I Residual Pesticides are detected above the limit of detection (LOD) and shall report the result of the Category II Residual Pesticides testing in unit micrograms per gram (µg/g) on the COA. The laboratory shall indicate “pass” or “fail” on the COA.
(c) The licensed laboratory shall establish a limit of quantitation (LOQ) of 0.10 µg/g or lower for all Category I Residual Pesticides.
(d) The sample shall be deemed to have passed the residual pesticides testing if both of the following conditions are met:
(1) The presence of any residual pesticide listed in the following tables in Category I are not detected, and
(2) The presence of any residual pesticide listed in the following tables in Category II does not exceed the indicated action levels.
Category I Residual Pesticide CAS No.
Aldicarb 116-06-3
Carbofuran 1563-66-2
Chlordane 57-74-9
Chlorfenapyr 122453-73-0
Chlorpyrifos 2921-88-2
Coumaphos 56-72-4
Daminozide 1596-84-5
DDVP (Dichlorvos) 62-73-7
Dimethoate 60-51-5
Ethoprop(hos) 13194-48-4
Etofenprox 80844-07-1
Fenoxycarb 72490-01-8
Fipronil 120068-37-3
Imazalil 35554-44-0
Methiocarb 2032-65-7
Methyl parathion 298-00-0
Mevinphos 7786-34-7
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 133 of 216 Category I Residual Pesticide CAS No.
Paclobutrazol 76738-62-0
Propoxur 114-26-1
Spiroxamine 118134-30-8
Thiacloprid 111988-49-9
Category II
Residual Pesticide CAS No.
Action Level (µg/g) for
Inhalable Cannabis and
Cannabis Products
Action Level (µg/g) for
Non-Inhalable Cannabis
Products
Abamectin 71751-41-2 0.1 0.3
Acephate 30560-19-1 0.1 5
Acequinocyl 57960-19-7 0.1 4
Acetamiprid 135410-20-7 0.1 5
Azoxystrobin 131860-33-8 0.1 40
Bifenazate 149877-41-8 0.1 5
Bifenthrin 82657-04-3 3 0.5
Boscalid 188425-85-6 0.1 10
Captan 133-06-2 0.7 5
Carbaryl 63-25-2 0.5 0.5
Chlorantraniliprole 500008-45-7 10 40
Clofentezine 74115-24-5 0.1 0.5
Cyfluthrin 68359-37-5 2 1
Cypermethrin 52315-07-8 1 1
Diazinon 333-41-5 0.1 0.2
Dimethomorph 110488-70-5 2 20
Etoxazole 153233-91-1 0.1 1.5
Fenhexamid 126833-17-8 0.1 10
Fenpyroximate 111812-58-9 0.1 2
Flonicamid 158062-67-0 0.1 2
Fludioxonil 131341-86-1 0.1 30
Hexythiazox 78587-05-0 0.1 2
Imidacloprid 138261-41-3 5 3
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 134 of 216 Category II
Residual Pesticide CAS No.
Action Level (µg/g) for
Inhalable Cannabis and
Cannabis Products
Action Level (µg/g) for
Non-Inhalable Cannabis
Products
Kresoxim-methyl 143390-89-0 0.1 1
Malathion 121-75-5 0.5 5
Metalaxyl 57837-19-1 2 15
Methomyl 16752-77-5 1 0.1
Myclobutanil 88671-89-0 0.1 9
Naled 300-76-5 0.1 0.5
Oxamyl 23135-22-0 0.5 0.2
Pentachloronitrobenzene 82-68-8 0.1 0.2
Permethrin 52645-53-1 0.5 20
Phosmet 732-11-6 0.1 0.2
Piperonylbutoxide 51-03-6 3 8
Prallethrin 23031-36-9 0.1 0.4
Propiconazole 60207-90-1 0.1 20
Pyrethrins 8003-34-7 0.5 1
Pyridaben 96489-71-3 0.1 3
Spinetoram 187166-15-0,
187166-40-1 0.1 3
Spinosad 131929-60-7,
131929-63-0 0.1 3
Spiromesifen 283594-90-1 0.1 12
Spirotetramat 203313-25-1 0.1 13
Tebuconazole 107534-96-3 0.1 2
Thiamethoxam 153719-23-4 5 4.5
Trifloxystrobin 141517-21-7 0.1 30
(e) If the sample fails residual pesticides testing, the batch from which the sample was collected fails residual pesticides 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.
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 135 of 216 §15720. Microbial Impurities Testing.
(a) The licensed laboratory shall analyze at minimum 1.0 grams of the representative sample of cannabis or cannabis products to determine whether microbial impurities are present.
(b) The licensed laboratory shall report the result of the microbial impurities testing by indicating “pass” or “fail” on the COA.
(c) The sample of inhalable cannabis and cannabis products 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) The sample of non-inhalable cannabis and cannabis products shall be deemed to have passed the microbial impurities testing if both the following conditions are met:
(1) Shiga toxin–producing Escherichia coli is not detected in 1 gram, and (2) Salmonella spp. is not detected in 1 gram.
(e) If the 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.
§15721. Mycotoxin Testing.
(a) The licensed laboratory shall analyze at minimum 0.5 grams of the representative sample of cannabis and cannabis products to determine whether mycotoxins are present.
(b) The licensed 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) The 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 the 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.
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 136 of 216 §15722. Foreign Material Testing.
(a) The licensed laboratory shall analyze the representative sample of cannabis and cannabis products to determine whether foreign material is present. (b) The licensed laboratory shall report the result of the foreign material test by indicating “pass” or “fail” on the COA.
(c) The licensed laboratory shall perform foreign material testing on the total representative sample prior to sample homogenization.
(d) When the licensed laboratory performs foreign material testing, at minimum, the laboratory shall do all of the following:
(1) Examine both the exterior and interior of the dried flower sample, and (2) Examine the exterior of the cannabis product sample. (e) The 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 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 the 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.
§15723. Heavy Metals Testing.
(a) The licensed laboratory shall analyze at minimum 0.5 grams of the representative sample of cannabis and cannabis products to determine whether heavy metals are present.
(b) The licensed laboratory shall report the result of the heavy metals test in unit micrograms per gram (µg/g) on the COA and indicate “pass” or “fail” on the COA. (c) The sample shall be deemed to have passed the heavy metals testing if the presence of heavy metals does not exceed the action levels listed in the following table.
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 137 of 216 Heavy Metal
Action Level (µg/g) for
Inhalable Cannabis and
Cannabis Products
Action Level (µg/g) for
Non-Inhalable Cannabis
and Cannabis Products
Cadmium 0.2 0.5
Lead 0.5 0.5
Arsenic 0.2 1.5
Mercury 0.1 3.0
(d) If the sample fails heavy metals testing, the batch from which the sample was collected fails heavy metals 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.
§15724. Cannabinoid Testing.
(a) The licensed laboratory shall analyze at minimum 0.5 grams of the representative sample of cannabis and cannabis products to determine the cannabinoid profile such as THC; THCA; CBD; CBDA; CBG; and CBN.
(b) The licensed laboratory shall establish a limit of quantitation (LOQ) of 1.0 mg/g or lower for all cannabinoids analyzed and reported.
(c) The licensed laboratory shall report the result of the cannabinoid testing on the COA, including, at minimum:
(1) A percentage for THC, THCA, CBD, and CBDA;
(A) When the licensed laboratory reports the result of the cannabinoid testing for harvest batch representative samples on the COA in dry-weight percent, they shall use the following equation:
Dry-weight percent cannabinoid = wet-weight percent cannabinoid / (1 − percent moisture / 100)
(2) A percentage for Total THC and Total CBD, if applicable; (3) Milligrams per gram (mg/g) if by dry-weight or milligrams per milliliter (mg/mL) if by volume for THC, THCA, CBD, and CBDA.
(4) Milligrams per gram (mg/g) if by dry-weight or milligrams per milliliter (mg/mL) if by volume for Total THC and Total CBD, if applicable;
(A) The licensed laboratory shall calculate the total cannabinoid concentration as follows:
(i) For concentration expressed in weight:
Total cannabinoid concentration (mg/g) = (cannabinoid acid form concentration (mg/g) x
0.877) + cannabinoid concentration (mg/g)
(ii) For concentration expressed in volume:
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 138 of 216 Total cannabinoid concentration (mg/mL) = (cannabinoid acid form concentration (mg/mL) x 0.877) + cannabinoid concentration (mg/mL)
(5) Milligrams per package for THC and CBD;
(6) Milligrams per package for Total THC and Total CBD, if applicable; (7) Milligrams per serving for THC and CBD, if any;
(8) Milligrams per serving for Total THC and Total CBD, if any and if applicable; and (9) The licensed laboratory shall report the results of all other cannabinoids analyzed on the COA both as a percentage and in either milligrams per gram (mg/g) if by weight or milligrams per milliliter (mg/mL) if by volume.
(d) The sample shall be deemed to have passed the cannabinoid testing if the amount of THC does not exceed the limits established in section 17304 of this division. (e) The licensed laboratory shall report the test results and indicate an overall “pass” or “fail” for the cannabinoid testing on the COA.
(f) Any cannabinoids found to be less than the LOQ shall be reported on the COA as “<1 mg/g” if by dry-weight or “<1 mg/mL” if by volume.
(g) 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. (h) For purposes of this division, any one cannabinoid, Total THC, and/or Total CBD claimed to be present on a label shall not be considered inaccurate if the difference in percentage on the certificate of analysis is plus or minus 10.0%. (i) Notwithstanding subsection (h), until January 1, 2022, for edible cannabis products where milligrams per serving for THC does not exceed 10 milligrams per serving, as provided for under section 17304(a)(1), Total THC claimed to be present on a label shall not be considered inaccurate if the difference in percentage on the COA is plus or minus
12.0%.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26100, 26104 and 26110, Business and Professions Code.
§15725. Terpenoid Testing.
(a) If requested, the licensed laboratory shall analyze at minimum 0.5 grams of the representative sample of cannabis or cannabis products to determine the terpenoid profile of the sample.
(b) The licensed laboratory shall report the result of the terpenoid testing on the COA both as a percentage and in either milligrams per gram (mg/g) if by weight or milligrams per milliliter (mg/mL) if by volume.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26100, 26104 and 26110, Business and Professions Code.
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 139 of 216 §15726. Certificate of Analysis (COA).
(a) The licensed laboratory shall generate a COA for each representative sample that the laboratory analyzes.
(b) The licensed laboratory shall ensure that the COA contains the results of all required analyses performed for the representative sample.
(c) The licensed laboratory shall, within 1 business day of completing all analyses of a sample, both upload the COA into the track and trace system and simultaneously provide a copy of the COA to the Department via email at [email protected]. (d) The licensed laboratory shall not release to any person any cumulative or individual test results prior to completing all analyses and providing the COA to the Department. (e) The COA shall contain, at minimum, the following information:
(1) The term “Regulatory Compliance Testing” in font no smaller than 14-point, which shall appear in the upper-right corner of each page of the COA. No text or images shall appear above the term “Regulatory Compliance Testing” on any page of the COA. (2) Laboratory’s name, licensed premises address, and license number; (3) Licensed distributor’s or licensed microbusiness authorized to engage in distribution’s name, licensed premises address, and license number;
(4) Licensed cultivator’s, licensed manufacturer’s, or licensed microbusiness’ name, licensed premises address, and license number;
(5) Batch number of the batch from which the sample was obtained. For cannabis and cannabis products that are already packaged at the time of sampling, the labeled batch number on the packaged cannabis and cannabis products shall match the batch number on the COA;
(6) Sample identifying information, including matrix type and unique sample identifiers; (7) Sample history, including the date collected, the date received by the laboratory, and the date(s) of sample analyses and corresponding testing results; (8) A picture of the sample of cannabis and cannabis products. If the sample is prepackaged, the picture must include an unobstructed image of the packaging; (9) For dried flower samples, the total weight of the batch, in grams or pounds, and the total weight, of the representative sample in grams;
(10) For cannabis product or pre-rolls samples, the total unit count of both the representative sample and the total batch size;
(11) Measured density of the cannabis and cannabis products; (12) The analytical methods, analytical instrumentation used, and corresponding Limits of Detection (LOD) and Limits of Quantitation (LOQ);
(13) An attestation on the COA from the laboratory supervisory or management employee that all LQC samples required by section 15730 of this division were performed and met the acceptance criteria; and
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 140 of 216 (14) Analytes detected during the analyses of the sample that are unknown, unidentified, or injurious to human health if consumed, if any.
(f) The licensed laboratory shall report test results for each representative sample on the COA as follows:
(1) Indicate an overall “pass” or “fail” for the entire batch; (2) When reporting qualitative results for each analyte, the licensed laboratory shall indicate “pass” or “fail”;
(3) When reporting quantitative results for each analyte, the licensed laboratory shall use the appropriate units of measurement as required under this chapter; (4) When reporting results for each test method, the licensed laboratory shall indicate “pass” or “fail”;
(5) When reporting results for any analytes that were detected below the analytical method LOQ, indicate “<LOQ”, notwithstanding cannabinoid results; (6) When reporting results for any analytes that were not detected or detected below the LOD, indicate “ND”; and
(7) Indicate “NT” for any test that the licensed laboratory did not perform. (g) The licensed laboratory supervisory or management employee shall validate the accuracy of the information contained on the COA and sign and date the COA. (h) The laboratory supervisory or management employee may request to amend a COA to correct minor errors. Requests must be emailed to the Department at [email protected] for approval prior to making any corrections. Errors in results required to be reported pursuant to subsection (f) are not minor errors.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26100, 26104 and 26110, Business and Professions Code.
Article 6. Post Testing Procedures
§15727. Remediation and Retesting.
(a) A cannabis or cannabis product batch that has been additionally processed after failed testing must be retested and successfully pass all the analyses required under this chapter.
(b) The licensed distributor or licensed microbusiness authorized to engage in distribution shall arrange for remediation of a failed cannabis or cannabis product batch. If the batch cannot be remediated, the batch shall be destroyed by the licensed distributor or licensed microbusiness authorized to engage in distribution.
(c) If a failed batch is not remediated or reprocessed in any way it cannot be retested.
Any subsequent COAs produced without remediation of the failed batch will not supersede the initial regulatory compliance testing COA. (d) A cannabis 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 be Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 141 of 216 destroyed.
(e) Within one business day of completing the required analyses of a representative sample obtained from a remediated cannabis or cannabis product batch, the laboratory shall upload the COA information into the track and trace system, or if the licensee does not yet have access to the track and trace system, it shall be emailed to the Department. (f) Nothing in this section shall be interpreted to prevent a cannabis or cannabis product batch from being retested when the COA is 12 or more months old.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26100, 26104 and 26110, Business and Professions Code.
§15728. Post Testing Sample Retention.
(a) The licensed laboratory shall retain the reserve sample, consisting of any portion of a sample that was not used in the testing process. The reserve sample shall be kept, at minimum, for 45 business days after the analyses, after which time it may be destroyed and denatured to the point the material is rendered unrecognizable and unusable. (b) The licensed laboratory shall securely store the reserve sample in a manner that prohibits sample degradation, contamination, and tampering. (c) The licensed laboratory shall provide the reserve sample to the Department upon request.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26100, 26104 and 26110, Business and Professions Code.
Article 7. Laboratory Quality Assurance and Quality Control §15729. Laboratory Quality Assurance (LQA) Program.
(a) The licensed laboratory shall develop and implement a LQA program to assure the reliability and validity of the analytical data produced by the laboratory. The LQA program shall, at minimum, include a written LQA manual that addresses the following:
(1) Quality control procedures;
(2) Laboratory organization and employee training and responsibilities, including good laboratory practice (GLP);
(3) LQA objectives for measurement data;
(4) Traceability of data and analytical results;
(5) Instrument maintenance, calibration procedures, and frequency; (6) Performance and system audits;
(7) Corrective action procedures;
(8) Steps to change processes when necessary;
(9) Record retention and document control;
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 142 of 216 (10) Test procedure standardization; and
(11) Method validation.
(b) The supervisory or management laboratory employee shall annually review, amend if necessary, and approve the LQA program and manual both when they are created and when there is a change in methods, laboratory equipment, or the supervisory or management laboratory employee.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26100, 26104 and 26110, Business and Professions Code.
§15730. Laboratory Quality Control (LQC) Samples.
The licensed laboratory shall use LQC samples and adhere to good laboratory practice (GLP) in the performance of each analysis according to the following specifications. (a)The licensed laboratory shall analyze LQC samples in the same manner as the laboratory analyzes cannabis and cannabis products samples. (b)The licensed laboratory shall use at least one negative control, one positive control, and one laboratory replicate sample in each analytical batch for each target organism during microbial testing. If one of the controls produces unexpected results, the samples shall be re- prepped and reanalyzed with a new set of controls.
(c) If the result of the microbial analyses is outside the specified acceptance criteria in the following table, the licensed laboratory shall determine the cause and take steps to remedy the problem until the result is within the specified acceptance criteria.
Laboratory Quality
Control Sample
Acceptance Criteria Corrective Action
Positive control Produces expected
result, positive result
Re-prep and reanalyze the entire analytical batch,
once. If problem persists, locate and remedy the
source of unexpected result, then re-prep samples
and reanalyze with a new set of controls.
Negative control Produces expected
result, negative
result
Re-prep and reanalyze the entire analytical batch,
once. If problem persists, locate and remedy the
source of unexpected result, then re-prep samples
and reanalyze with a new set of controls.
Laboratory replicate
sample
Sample results must
concur
Reanalyze sample and associated replicate
sample once. If problem persists, re-prep samples
and reanalyze.
(d) The licensed laboratory shall prepare and analyze at least one of each of the following LQC samples for each analytical batch:
(1) Method Blank;
(2) Laboratory control sample (LCS); and
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 143 of 216 (3) Laboratory replicate sample or matrix spike sample. (e) The laboratory shall analyze, at minimum, a continuing calibration verification (CCV) sample at the beginning of each analytical sequence and every 10 samples thereafter. (f) If the result of the chemical 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.
Laboratory Quality
Control Sample
Acceptance Criteria Corrective Action
Method Blank sample Not to exceed LOQ Reanalyze entire analytical batch once. If method blank is still greater than the LOQ for
any analyte, locate the source of contamination
then re-prep samples and reanalyze.
LCS Percent recovery 70%
to 130%
Reanalyze the entire analytical batch, once. If
problem persists, re-prep samples and
reanalyze or re-run the initial calibration curve.
Laboratory replicate
sample
RPD ≤30% Reanalyze sample and associated replicate
sample once. If problem persists, re-prep
samples and reanalyze.
Matrix spike sample Percent recovery
between 70% to 130%
Reanalyze sample and associated matrix spike
sample once. If problem persists, re-prep
samples and reanalyze.
CCV Percent recovery
between 70% to 130%
Reanalyze all samples that followed the last
CCV that met the acceptance criteria. If CCV
still fails, re-run the initial calibration curve and
all samples in the analytical sequence.
(g) If any analyte is detected above any action level, as described in this chapter, the sample shall be re-prepped and reanalyzed in replicate within another analytical batch. (1) For quantitative analyses, the re-prepped sample and its associated replicate must meet the acceptance criteria of RPD ≤30%.
(2) For qualitative analyses, the re-prepped sample and its associated replicate results must concur.
(h) If any LQC sample produces a result outside of the acceptance criteria, the laboratory cannot report the result and the entire batch cannot be released for retail sale. The laboratory shall determine the cause and take steps to remedy the problem until the result is within the specified acceptance criteria.
(i) If the licensed laboratory determines that the result is a false-positive or a falsenegative, the Department may ask for the laboratory to re-sample or re-test.
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 144 of 216 (j) The licensed laboratory shall compile and generate one LQC sample report for each analytical batch that includes LQC acceptance criteria, measurements, analysis date, and matrix.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26100, 26104 and 26110, Business and Professions Code.
§15731. Limits of Detection (LOD) and Limits of Quantitation (LOQ) for Quantitative Analyses.
(a) The licensed 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 spiked Blank samples calculated as follows; LOD = (3.3 x standard deviation of the response) / slope of the calibration curve; or (3) A method published by the United States Food and Drug Administration (USFDA) or the United States Environmental Protection Agency (USEPA). (b) The licensed 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 spiked 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.
§15732. Data Package.
(a) The licensed laboratory shall compile and generate one data package for each representative sample that the laboratory analyzes.
(b) The licensed laboratory shall create a data package and use the Data Package Cover Page and Checklist Form, DCC-LIC-024 (Amended 9/21), which is incorporated herein by reference. The data package and form DCC-LIC-024 (Amended 9/21) shall be provided to the Department immediately upon request.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26100, 26104, 26110 and 26160, Business and Professions Code.
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 145 of 216 §15733. Required Proficiency Testing.
(a) The licensed laboratory shall participate in a proficiency testing program provided by an organization that operates in conformance with the requirements of ISO/IEC 17043, at least once every six months.
(b) The licensed laboratory shall annually, successfully participate in a proficiency testing program for each of the following test methods:
(1) Cannabinoids;
(2) Heavy metals;
(3) Microbial impurities;
(4) Mycotoxins;
(5) Residual pesticides;
(6) Residual solvents and processing chemicals; and
(7) If tested, terpenoids.
(c) The licensed laboratory shall report all analytes available by the proficiency testing program provider and for which the licensee is required to test as required under this chapter.
(d) The licensed laboratory shall participate in the proficiency testing program by following the laboratory’s existing SOPs for testing cannabis and cannabis products. (e) The licensed laboratory shall rotate the proficiency testing program among the laboratory employees who perform the test methods.
(f) Laboratory employees who participate in a proficiency testing program shall sign the corresponding analytical reports or attestation statements to certify that the proficiency testing program was conducted in the same manner as the laboratory tests of cannabis and cannabis products.
(g) A supervisory or management laboratory employee shall review and verify the accuracy of results reported for all proficiency testing program samples analyzed. (h) The licensed laboratory shall request the proficiency testing program provider to send results concurrently to the Department, if available, or the laboratory shall provide the proficiency testing program results to the Department within 3 business days after the laboratory receives notification of their test results from the proficiency testing program provider. Any results shall be reported by submitting the Licensee Notification and Request Form, Notifications and Requests Regarding Testing Laboratories, DCC-LIC029 (New 9/21), which is incorporated herein by reference.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26100 and 26110, Business and Professions Code.
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 146 of 216 §15734. Satisfactory and Unsatisfactory Proficiency Test Performance. (a) The licensed laboratory shall be deemed to have successfully participated in a proficiency testing program for an analyte tested in a specific method if the test results demonstrate a “satisfactory” or otherwise proficient performance determination by the proficiency testing program provider.
(b) The licensed laboratory may not report test results for analytes that are deemed by the proficiency testing program provider as “unacceptable,” “questionable,” “unsatisfactory”, or otherwise deficient.
(c) The licensed laboratory may resume reporting test results for analytes that were deemed “unacceptable,” “questionable,” “unsatisfactory”, or otherwise deficient, only if both of the following conditions are met:
(1) The licensed laboratory satisfactorily remedies the cause of the failure for each analyte; and
(2) The licensed laboratory submits, to the Department, a written corrective action report demonstrating how the laboratory has fixed the cause of the failure.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26100 and 26110, Business and Professions Code.
§15735. Laboratory Audits.
(a) The licensed 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 licensed laboratory shall submit the results of the internal audit to the Department. (d) Within 3 business days of receiving the accrediting body on=site audit findings, the licensed laboratory shall submit the results to the Department. (e) The licensed laboratory shall submit any audit results to the Department, accompanied by the Licensee Notification and Request Form, Notifications and Requests Regarding Testing Laboratories, DCC-LIC-029 (New 9/21), which is incorporated herein by reference.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26100 and 26104, Business and Professions Code.
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 147 of 216 Article 8. Laboratory Employee Qualifications
§15736. General Laboratory Employee Qualifications.
(a) The licensed laboratory may only employ persons who are at least 21 years of age. (b) The licensed laboratory shall develop and implement an employee training program to ensure competency of laboratory employees for their assigned functions. (c) The licensed laboratory shall ensure and document that each laboratory employee meets the employee qualifications.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26102 and 26104, Business and Professions Code.
§15737. Supervisor or Management Responsibilities and Qualifications. (a) The licensed laboratory shall employ a supervisor or management employee who must be responsible for:
(1) Overseeing and directing the scientific methods of the licensed laboratory; (2) Ensuring that the licensed laboratory achieves and maintains a laboratory quality assurance program as required by section 15729 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 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;
(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; or
(4) A bachelor’s degree in any field from an accredited college or university, plus at least 8 years of full-time practical experience, 4 years of which must have been in a supervisory or management position.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26102 and 26104, Business and Professions Code.
§15738. Analyst and Sampler Qualifications.
(a) The licensed 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 Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 148 of 216 (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 licensed 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.
Chapter 7. Cultivators
Article 1. General Cultivation Requirements
§16201. Cultivation License Types.
License types include:
(a) Specialty Cottage:
(1) “Specialty Cottage Outdoor” is an outdoor cultivation site with up to 25 mature plants or 2,500 square feet or less of total canopy.
(2) “Specialty Cottage Indoor” is an indoor cultivation site with 500 square feet or less of total canopy.
(3) “Specialty Cottage Mixed-Light Tier 1 and 2” is a mixed-light cultivation site with 2,500 square feet or less of total canopy.
(b) Specialty:
(1) “Specialty Outdoor” is an outdoor cultivation site with less than or equal to 5,000 square feet of total canopy, or up to 50 mature plants on noncontiguous plots. (2) “Specialty Indoor” is an indoor cultivation site with between 501 and 5,000 square feet of total canopy.
(3) “Specialty Mixed-Light Tier 1 and 2” is a mixed-light cultivation site with between 2,501 and 5,000 square feet of total canopy.
(c) Small:
(1) “Small Outdoor” is an outdoor cultivation site with between 5,001 and 10,000 square feet of total canopy.
(2) “Small Indoor” is an indoor cultivation site with between 5,001 and 10,000 square feet of total canopy.
(3) “Small Mixed-Light Tier 1 and 2” is a mixed-light cultivation site with between 5,001 and 10,000 square feet of total canopy.
(d) Medium:
(1) “Medium Outdoor” is an outdoor cultivation site with between 10,001 square feet and Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 149 of 216 one acre of total canopy.
(2) “Medium Indoor” is an indoor cultivation site with between 10,001 and 22,000 square feet of total canopy.
(3) “Medium Mixed-Light Tier 1 and 2” is a mixed-light cultivation site with between 10,001 and 22,000 square feet of total canopy.
(e) “Nursery” is a cultivation site that conducts only cultivation of clones, immature plants, seeds, and other agricultural products used specifically for the propagation of cultivation of cannabis.
(f) “Processor” is a cultivation site that conducts only trimming, drying, curing, grading, packaging, and labeling of cannabis and nonmanufactured cannabis products.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26012, 26013, 26050 and 26061, Business and Professions Code.
§16202. General Cultivation Requirements.
(a) Licensees are prohibited from transferring any commercially cultivated cannabis or nonmanufactured cannabis products from their licensed premises. All transfers of cannabis and nonmanufactured cannabis product from a licensed cultivation premises must be conducted by a distributor licensed by the Department. (b) Outdoor cultivation licensees are prohibited from using light deprivation. Artificial lighting is permissible only to maintain immature plants outside the canopy area.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26010, 26012, 26013, 26050 and 26053, Business and Professions Code. §16209. Medium Cultivation License Limits.
A person or owner shall be limited to one (1) Medium Outdoor, or one (1) Medium Indoor, or one (1) Medium Mixed-Light A-License or M-License. This section shall remain in effect until January 1, 2023.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26012, 26013, 26050 and 26061, Business and Professions Code.
Article 2. Cultivation Site Requirements
§16300. Cultivation Requirements for Specialty Cottage, Specialty, Small, and Medium Licenses.
(a) Cannabis plants maintained outside of the designated canopy area(s) for specialty cottage, specialty, small, and medium licenses are prohibited from flowering. Should a plant outside of the canopy area(s) begin to flower, a plant tag shall be applied, the plant shall be moved to a designated canopy area and reported in the track and trace system without delay.
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 150 of 216 (b) All plants or portions of a plant used for seed production shall be tagged with a plant tag pursuant to section 15048.4.
(c) A licensee propagating immature plants for distribution or seed for distribution to another licensee shall obtain a nursery license.
(d) Licensees shall process their harvested cannabis only in area(s) designated for processing in their cultivation plan, or transfer their harvested cannabis to a licensed processor, manufacturer, or distributor via a licensed distributor.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26013, 26060 and 26120, Business and Professions Code.
§16301. Seed Production Requirements for Nursery Licensees.
Nursery licensees producing seed for distribution shall tag all mature plants with a plant tag pursuant to section 15048.4(b). All products, except seed, derived from these plants are prohibited from entering the commercial distribution chain.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26013, 26060 and 26067, Business and Professions Code.
§16302. Research and Development Requirements for Nursery Licensees.
Nursery licensees may maintain a research and development area, as identified in their cultivation plan, for the cultivation of mature plants. All mature plants shall be tagged with a plant tag pursuant to section 15048.4. All cannabis and cannabis products derived from these plants are prohibited from entering the commercial distribution chain or being transferred off the licensed premises.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26013, 26060 and 26067, Business and Professions Code.
§16303. Cultivation Requirements for Processor Licensees. (a) Processor licensees shall comply with all of the following requirements:
(1) All aggregation of product shall adhere to track and trace requirements. (2) Licensees may produce nonmanufactured cannabis products without a manufacturing license.
(3) Cultivation of cannabis plants is prohibited at a licensed processor premises.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26013, 26060, 26067, 26069 and 26120, Business and Professions Code. §16304. General Environmental Protection Measures.
(a) All licensed cultivators shall comply with all of the following environmental protection measures:
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 151 of 216 (1) Principles, guidelines, and requirements adopted pursuant to section 13149 of the Water Code and implemented by the State Water Resources Control Board, Regional Water Quality Control Boards, or California Department of Fish and Wildlife; (2) Any conditions of licensure included pursuant to section 26060.1(b)(1) of the Business and Professions Code;
(3) Requirements of section 7050.5(b) of the Health and Safety Code if human remains are discovered during cultivation activities;
(4) Requirements for generators pursuant to section 16306; (5) Requirements for pesticides pursuant to section 16307; (6) Outdoor lights used for safety or security purposes are shielded and downward facing; and
(7) Lights used for indoor or mixed-light cultivation are shielded from sunset to sunrise to reduce nighttime glare.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26013, 26060, 26066 and 26201, Business and Professions Code.
§16305. Renewable Energy Requirements.
(a) Beginning January 1, 2023, all holders of indoor, tier 2 mixed-light license types of any size, and all holders of nursery licenses using indoor or tier 2 mixed-light techniques shall ensure that electrical power used for commercial cannabis activity meets the average electricity greenhouse gas emissions intensity required by their local utility provider pursuant to the California Renewables Portfolio Standard Program in division 1, part 1, chapter 2.3, article 16 (commencing with section 399.11) of the Public Utilities Code.
(b) If a licensed cultivator’s average weighted greenhouse gas emission intensity, as calculated and reported upon license renewal pursuant to section 15020, is greater than the local utility provider’s greenhouse gas emission intensity, the licensee shall obtain carbon offsets to cover the excess in carbon emissions from the previous annual licensed period. The carbon offsets shall be purchased from one or more of the following recognized voluntary carbon registries:
(1) American Carbon Registry;
(2) Climate Action Reserve; or
(3) Verified Carbon Standard.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26013, 26060, 26066 and 26201, Business and Professions Code.
§16306. Generator Requirements.
(a) For the purposes of this section, “generator” means a stationary or portable compression ignition engine as defined in title 17, California Code of Regulations, section Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 152 of 216 93115.4.
(b) Licensed cultivators using generators rated at fifty (50) horsepower and greater shall demonstrate compliance with the Airborne Toxic Control Measure for stationary or portable engines, as applicable, established in title 17, California Code of Regulations, sections 93115-93116.5. Compliance shall be demonstrated by providing a copy of one of the following to the Department upon request:
(1) For portable engines, a Portable Equipment Registration Certificate provided by the California Air Resources Board; or
(2) For portable or stationary engines, a Permit to Operate or other proof of engine registration, obtained from the Local Air District with jurisdiction over the licensed premises.
(c) Licensed cultivators using generators rated below fifty (50) horsepower shall comply with the following by 2023:
(1) Either subsection (1)(A) or (1)(B):
(A) Meet the “emergency” definition for portable engines in title 17, California Code of Regulations, section 93116.2(a)(12), or the “emergency use” definition for stationary engines in title 17, California Code of Regulations, section 93115.4(a)(30); or (B) Operate eighty (80) hours or less in a calendar year; and (2) Either subsection (2)(A) or (2)(B):
(A) Meet Tier 3 with Level 3 diesel particulate filter requirements in title 13, California Code of Regulations, sections 2700-2711; or
(B) Meet Tier 4 requirements, or current engine requirements if more stringent, in title 40, Code of Federal Regulations, chapter I, subchapter U, part 1039, subpart B, section 1039.101.
(d) All generators used by licensed cultivators shall be equipped with non-resettable hour-meters. If a generator does not come equipped with a non-resettable hour-meter, an after-market non-resettable hour-meter shall be installed.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26013, 26060, 26066 and 26201, Business and Professions Code.
§16307. Pesticide Use Requirements.
(a) Licensed cultivators shall comply with all applicable pesticide statutes and regulations enforced by the Department of Pesticide Regulation.
(b) For all pesticides that are exempt from registration requirements, licensed cultivators shall comply with all applicable pesticide statutes and regulations enforced by the Department of Pesticide Regulation and the following pesticide application and storage protocols:
(1) Comply with all pesticide label directions;
(2) Store chemicals in a secure building or shed to prevent access by wildlife; Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 153 of 216 (3) Contain any chemical leaks and immediately clean up any spills; (4) Apply the minimum amount of product necessary to control the target pest; (5) Prevent offsite drift;
(6) Do not apply pesticides when pollinators are present; (7) Do not allow drift to flowering plants attractive to pollinators; (8) Do not spray directly to surface water or allow pesticide product to drift to surface water. Spray only when wind is blowing away from surface water bodies; (9) Do not apply pesticides when they may reach surface water or groundwater; and (10) Only use properly labeled pesticides. If no label is available, consult the Department of Pesticide Regulation.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26013, 26060, 26066 and 26201, Business and Professions Code.
§16308. Canopy Requirements.
(a) Licensed cultivators shall comply with the following requirements for canopy areas:
(1) Each canopy shall be marked with clearly identifiable physical boundaries around all areas that will contain mature plants. Physical boundaries include, but are not limited to, interior walls, shelves, greenhouse walls, hoop house walls, garden benches, hedgerows, fencing, garden beds, garden plots, or stakes delineating the perimeter. (2) Each canopy shall be of sufficient size to contain the mature plants in their entirety at any point in time. No portion of the plant is permitted to hang over an established canopy boundary.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26013 and 26060, Business and Professions Code.
§16309. Cultivation Plan Requirements.
(a) Licensed cultivators shall establish and maintain a cultivation plan that includes all of the following:
(1) A premises diagram drafted in accordance with section 15006. (2) A cannabis waste management plan developed in accordance with section 17223. (3) A pest management plan developed in accordance with section 16310.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26013, 26051.5, and 26060, Business and Professions Code.
§16310. Pest Management Plan.
(a) The licensed cultivator shall develop a pest management plan that includes:
(1) The product name and active ingredient(s) of all pesticides to be applied to cannabis; Department of Cannabis Control
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(2) Any integrated pest management protocols, including chemical, biological, and cultural methods, that will be used to prevent and control pests on the cultivation site.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26013, 26051.5 and 26060, Business and Professions Code.
§16311. Supplemental Water Source Information.
The following information shall be provided for each water source identified by the applicant:
(a) Retail water supply sources:
(1) If the water source is a retail water supplier, as defined in section 13575 of the Water Code, such as a municipal provider, provide the following:
(A) Name of the retail water supplier; and
(B) A copy of the most recent water service bill.
(2) If the water source is a small retail water supplier, such as a delivery service, and is subject to section 26060.1(a)(1)(B) of the Business and Professions Code and the retail water supplier contract is for delivery or pickup of water from a surface water body or an underground stream flowing in a known and definite channel, provide all of the following:
(A) The name of the retail water supplier under the contract; (B) The water source and geographic location coordinates, in either latitude and longitude or the California Coordinate System, of any point of diversion used by the retail water supplier to divert water delivered to the commercial cannabis business under the contract;
(C) The authorized place of use of any water right used by the retail water supplier to divert water delivered to the commercial cannabis business under the contract; (D) The maximum amount of water delivered to the commercial cannabis business for cannabis cultivation in any year; and
(E) A copy of the most recent water service bill.
(3) If the water source is a small retail water supplier, such as a delivery service, and is subject to section 26060.1(a)(1)(B) of the Business and Professions Code and the retail water supplier contract is for delivery or pickup of water from a groundwater well, provide all of the following:
(A) The name of the retail water supplier under the contract; (B) The geographic location coordinates for any groundwater well used to supply water delivered to the commercial cannabis business, in either latitude and longitude or the California Coordinate System;
(C) The maximum amount of water delivered to the commercial cannabis business for cannabis cultivation in any year;
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 155 of 216 (D) A copy of the well completion report filed with the Department of Water Resources pursuant to section 13751 of the Water Code for each percolating groundwater well used to divert water delivered to the commercial cannabis business. If no well completion report is available, the applicant shall provide evidence from the Department of Water Resources indicating that the Department of Water Resources does not have a record of the well completion report. When no well completion report is available, the State Water Resources Control Board may request additional information about the well; and (E) A copy of the most recent water service bill.
(b) If the water source is a groundwater well, provide the following:
(1) The groundwater well’s geographic location coordinates, in either latitude and longitude or the California Coordinate System; and
(2) A copy of the well completion report filed with the Department of Water Resources pursuant to section 13751 of the Water Code. If no well completion report is available, the applicant shall provide evidence from the Department of Water Resources indicating that the Department of Water Resources does not have a record of the well completion report. If no well completion report is available, the State Water Resources Control Board may request additional information about the well.
(c) If the water source is a rainwater catchment system, provide the following:
(1) The total square footage of the catchment footprint area(s); (2) The total storage capacity, in gallons, of the catchment system(s); and (3) A detailed description and photographs of the rainwater catchment system infrastructure, including the location, size, and type of all surface areas that collect rainwater. Examples of rainwater collection surface areas include a rooftop and greenhouse.
(d) If the water source is a diversion from a waterbody (such as a river, stream, creek, pond, lake, etc.), provide any applicable water right statement, application, permit, license, or small irrigation use registration identification number(s), and either:
(1) A copy of any applicable statement, registration certificate, permit, license, or proof of a pending application issued under part 2 (commencing with section 1200) of division 2 of the California Water Code as evidence of approval of a water diversion by the State Water Resources Control Board; or
(2) If the commercial cannabis business has claimed an exception from the requirement to file a statement of diversion and use pursuant to section 5101 of the Water Code, provide a copy of the documentation submitted to the State Water Resources Control Board before January 1, 2019, demonstrating that the diversion is subject to subdivision (a), (c), (d), or (e) of section 5101 of the Water Code.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26013 and 26060.1, Business and Professions Code.
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 156 of 216 Article 3. Release of Information to Financial Institutions §16410. Cultivation Licensee Authorization to Release Data to Financial Institutions.
(a) A cultivation licensee may authorize the Department to provide information to a financial institution for purposes of facilitating the provision of financial services. The authorization shall be made in writing, through a form prescribed by the Department, which shall include the following information:
(1) The name of the licensed business for which the licensee is authorizing the release of information;
(2) The business's license number(s);
(3) The financial institution authorized to receive information; (4) The name, phone number, email address, and signature of the owner submitting the authorization;
(5) The categories of information specified in subsection (b) that are authorized for release; and
(6) An acknowledgement that the authorization to release information includes information that is otherwise protected from disclosure, that the licensee is waiving privilege and confidentiality, and that the scope of the release is strictly limited for the purposes of disclosure to the financial institution.
(b) After receipt of the authorization from a cultivation licensee, the Department shall release the following information, when requested by an authorized financial institution pursuant to section 16411 of this division:
(1) The license application(s), including renewal applications, excluding information required to be kept confidential pursuant to Penal Code section 11105 and confidential personal information of individual owners of the licensed business; (2) Information captured in the track and trace system established pursuant to Business and Professions Code section 26067, including, but not limited to, aggregated sales or transfer information, as applicable;
(3) Documents issued to the licensee pursuant to disciplinary or enforcement proceedings;
(c) A cultivation licensee may withdraw the authorization to provide information to a financial institution at any time. The withdrawal shall be made in writing, through a form prescribed by the Department, and shall include the following information:
(1) The name of the licensed business for which the licensee is withdrawing the authorization of the release of information;
(2) The business's license number(s);
(3) The financial institution from which authorization to receive information is withdrawn; Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 157 of 216 (4) The name, phone number, email address, and signature of the owner submitting the withdrawal.
Authority: Section 26013, Business and Professions Code. Reference: Section 26260, Business and Professions Code.
§16411. Financial Institution Request for Cultivation Licensee Information.
A financial institution as defined in Business and Professions Code section 26260(c)(3) may request information related to a cultivation licensee for purposes of facilitating the provision of financial services for that licensee. The request shall be made in writing, through a form prescribed by the Department, which shall include the following information:
(a) The name of the financial institution;
(b) The name, phone number, email, and signature of the representative of the financial institution requesting information;
(c) The business name and license number of the licensee for which the financial institution is requesting information;
(d) The type of financial services for which the information is requested (including, but not limited to, establishment or maintenance of bank accounts, extending loans, and providing insurance) and whether the request is for consideration of a new service or maintenance of an existing service;
(e) The specific information requested as described in section 16410(b) if authorized by the licensee; and
(f) An acknowledgment that use of the information is limited to that which is necessary for the provision of financial services.
Authority: Section 26013, Business and Professions Code. Reference: Section 26260, Business and Professions Code.
Chapter 8. Manufacturers
Article 1. Manufacturing Licenses
§17006. Manufacturing License Types.
The following manufacturing license types are available from the Department:
(a) “Type 7,” for extractions using volatile solvents as defined by section 15000(xxx). A Type 7 licensee may also:
(1) Conduct extractions using nonvolatile solvents or mechanical methods on the licensed premises, provided that the extraction process is noted on the application and the relevant information pursuant to section 15011(b) is provided to the Department; (2) Conduct infusion operations on the licensed premises, provided the infusion operations and product types are noted on the application and the relevant information Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 158 of 216 pursuant to section 15011(b) is provided to the Department; (3) Conduct packaging and labeling of cannabis products on the licensed premises; and (4) Register and operate the licensed premises as a shared-use facility in accordance with article 2 (commencing with section 17124) of chapter 8. (b) “Type 6,” for extractions using mechanical methods or nonvolatile solvents as defined by section 15000(uu). A Type 6 licensee may also:
(1) Conduct infusion operations on the licensed premises, provided the infusion operations and product types are noted on the application and the relevant information pursuant to section 15011(b) is provided to the Department; (2) Conduct packaging and labeling of cannabis products on the licensed premises; and (3) Register and operate the licensed premises as a shared-use facility in accordance with article 2 (commencing with section 17124) of chapter 8. (c) “Type N,” for manufacturers that produce cannabis products other than extracts or concentrates that are produced through extraction. A Type N licensee may also:
(1) Conduct packaging and labeling of cannabis products on the licensed premises; and (2) Register and operate the licensed premises as a shared-use facility in accordance with article 2 (commencing with section 17124) of chapter 8. (d) “Type P,” for manufacturers that only package or repackage cannabis products or label or relabel cannabis product containers or wrappers. (e) “Type S,” for manufacturers that conduct commercial cannabis manufacturing activities in accordance with article 2 (commencing with section 17124) of chapter 8 at a registered shared-use facility.
Authority: Sections 26013 and 26130, Business and Professions Code. Reference:
Sections 26012, 26050 and 26130, Business and Professions Code. §17009. Additional Activities.
In addition to the activities specified in section 17006, a licensed manufacturer may also roll and package pre-rolls and package dried cannabis flower.
Authority: Sections 26013 and 26130, Business and Professions Code. Reference:
Sections 26012 and 26130, Business and Professions Code. §17117. License Constraints.
(a) A manufacturer licensee shall not manufacture, prepare, package or label any products other than cannabis products at the licensed premises. (b) No licensee shall employ or retain an individual under 21 years of age. (c) A manufacturer licensee shall only use cannabinoid concentrates and extracts that are manufactured or processed from cannabis obtained from a licensed cannabis cultivator.
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 159 of 216 (d) A manufacturer licensee shall not manufacture, prepare, package, or label cannabis products in a location that is operating as a retail food establishment or as a processed food registrant.
(e) A manufacturer licensee shall not manufacture, prepare, package, or label cannabis products in a location that is licensed by the Department of Alcoholic Beverage Control pursuant to division 9 (commencing with section 23000) of the Business and Professions Code.
Authority: Section 26013 and 26130, Business and Professions Code. Reference:
Sections 26050 and 26140, Business and Professions Code. §17123.1. Manufacturing Licensee Authorization to Release Data to Financial Institutions.
(a) A manufacturing licensee may authorize the Department to provide information to a financial institution for purposes of facilitating the provision of financial services. The authorization shall be made in writing, through a form prescribed by the Department, which shall include the following information:
(1) The name of the licensed business for which the licensee is authorizing the release of information;
(2) The business’s license number(s);
(3) The financial institution authorized to receive information; (4) The name, phone number, email address, and signature of the owner submitting the authorization;
(5) The categories of information specified in subsection (b) that are authorized for release; and
(6) An acknowledgement that the authorization to release information includes information that is otherwise protected from disclosure, and waiving privilege and confidentiality is strictly for purposes of disclosure to the financial institution. (b) After receipt of the authorization from a manufacturing licensee, the Department shall release the following information, as designated by the licensee, when requested by an authorized financial institution pursuant to section 17123.2 of this division:
(1) The license application(s), including renewal applications, excluding information required to be kept confidential pursuant to Penal Code section 11105 and confidential personal information of individual owners of the licensed business; (2) Information captured in the track and trace system established pursuant to Business and Professions Code section 26067, including, but not limited to, aggregated sales or transfer information, as applicable; and
(3) Documents issued to the licensee pursuant to disciplinary or enforcement proceedings.
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 160 of 216 (c) A licensee may withdraw the authorization to provide information to a financial institution at any time. The withdrawal shall be made in writing, through a form prescribed by the Department, and shall include the following information:
(1) The name of the licensed business for which the licensee is withdrawing the authorization of the release of information;
(2) The business’s license number(s);
(3) The financial institution from which authorization to receive information is withdrawn; and
(4) The name, phone number, email address, and signature of the owner submitting the withdrawal.
Authority: Section 26013, Business and Professions Code. Reference: Section 26260, Business and Professions Code.
§17123.2. Financial Institution Request for Manufacturing Licensee Information.
A financial institution as defined in Business and Professions Code section 26260(c)(3) may request information related to a manufacturing licensee for purposes of facilitating the provision of financial services for that licensee. The request shall be made in writing, through a form prescribed by the Department, which shall include the following information:
(a) The name of the financial institution;
(b) The name, phone number, email, and signature of the representative of the financial institution requesting information;
(c) The business name and license number of the licensee for which the financial institution is requesting information;
(d) The type of financial services for which the information is requested (including, but not limited to, establishment or maintenance of bank accounts, extending loans, and providing insurance) and whether the request is for consideration of a new service or maintenance of an existing service;
(e) The specific information requested as described in section 17123.1(b) if authorized by the licensee; and
(f) An acknowledgment that use of the information is limited to that which is necessary for the provision of financial services.
Authority: Section 26013, Business and Professions Code. Reference: Section 26260, Business and Professions Code.
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 161 of 216 Article 2. Shared-Use Facilities
§17124. Definitions.
For purposes of this article, the following definitions shall apply:
(a) “Common-use area” means any area of the manufacturer’s registered shared-use facility, including equipment that is available for use by more than one licensed manufacturer, provided that the use of a common-use area is limited to one licensee at a time.
(b) “Designated area” means the area of the manufacturer’s registered shared-use facility that is designated by the primary licensee for the sole and exclusive use of a Type S licensee, including storage of the Type S licensee’s cannabis, cannabis concentrates, and cannabis products.
(c) “Primary licensee” means the Type 7, Type 6, or Type N licensee that has registered and been approved to operate its licensed premises as a shared-use facility. (d) “Shared-use facility” means a manufacturing premises operated by a Type 7, Type 6, or Type N licensee in which Type S licensees are authorized to conduct manufacturing operations.
(e) “Use agreement” means a written agreement between a primary licensee and a Type S commercial cannabis business or licensee that specifies the designated area of the Type S licensee, the days and hours in which the Type S licensee is assigned to use the common-use area, any allocation of responsibility for compliance pursuant to section 17128, and an acknowledgement that the Type S licensee has sole and exclusive use of the common-use area during the Type S licensee’s assigned time period.
Authority: Sections 26013 and 26130, Business and Professions Code. Reference:
Sections 26001, 26050, 26051.5 and 26130, Business and Professions Code. §17126. Registration to Operate a Shared-Use Facility.
(a) No licensed manufacturer shall operate as a shared-use facility without prior approval by the Department.
(b) To register as a shared-use facility, a Type 7, Type 6, or Type N licensee shall submit the following to the Department through the online licensing system:
(1) A copy of the license, permit, or other authorization issued by the local jurisdiction that enables the licensee to operate as a shared-use facility. The Department shall contact the applicable local jurisdiction to confirm the validity of the authorization upon receipt of the application for registration. If the local jurisdiction does not respond within 10 calendar days, the Department shall consider the authorization valid. (2) A registration form prescribed by the Department, which includes the following information:
(A) The proposed occupancy schedule that specifies the days and hours the commonuse area will be available for use by Type S licensees and when the common-use area will be used by the primary licensee. The occupancy schedule shall allow for Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 162 of 216 maintenance and sanitizing between uses by individual licensees. (B) A diagram indicating:
(i) Each designated area for Type S licensee(s).
(ii) The common-use area, including identification of any shared equipment. (c) The Department shall notify the Type 7, Type 6, or Type N licensee upon approval of the registration to operate as a shared-use facility. Notification shall be made through the online licensing system.
(d) At least one business day prior to a Type S licensee commencing manufacturing operations at a registered shared-use facility, the primary licensee shall provide written notification to the Department. The notification to the Department shall include the Type S licensee’s business name, contact person, contact phone number, and license number. The primary licensee shall also provide an updated occupancy schedule that includes the Type S licensee and an updated diagram that specifies the Type S licensee’s designated area. Notification shall be provided by email or through the online licensing system.
(e) A primary licensee that wishes to discontinue operation as a shared-use facility may cancel its registration by providing written notice to the Department and each Type S licensee authorized to use the shared-use facility at least 30 calendar days prior to the effective date of the cancellation.
Authority: Sections 26013 and 26130, Business and Professions Code. Reference:
Sections 26051.5, 26055 and 26130, Business and Professions Code. §17127. Shared-Use Facility Conditions for Operation.
(a) A primary licensee shall operate the shared-use facility in accordance with the conditions of operation specified in this section.
(b) Each Type S licensee shall be assigned a “designated area” that, at minimum:
(1) Is for exclusive use by the Type S licensee; and
(2) Provides an area for storage that is secure, fixed in place, locked with a commercialgrade lock, and accessible only to the Type S licensee for storage of that Type S licensee’s cannabis, cannabis concentrates, and cannabis products. (c) Any part of the premises used for manufacturing activities that is a common-use area shall be occupied by only one licensee at a time by restricting the time period that each licensee may use the common-use area. During the assigned time period, one licensee shall have sole and exclusive occupancy of the common-use area. (d) The use of the shared-use facility shall be restricted to the primary licensee and the Type S licensees authorized by the Department to use the shared-use facility. (e) Any cannabis product or other materials remaining after a Type S licensee ceases operation and discontinues use of its designated area shall be considered cannabis waste and disposed of by the primary licensee consistent with the requirements of the Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 163 of 216 Act and this division.
(f) The shared-use facility shall meet all applicable requirements of the Act and this division.
(g) The occupancy schedule shall be prominently posted near the entrance to the shared-use facility.
(h) The primary licensee may conduct manufacturing activities as permitted under its Type 7, Type 6, or Type N license and may use the common-use area during its scheduled time period.
Authority: Sections 26013 and 26130, Business and Professions Code. Reference:
Sections 26011.5 and 26130, Business and Professions Code. §17128. Shared-Use Facility Compliance Requirements.
(a) As part of the use agreement, the primary licensee and the Type S licensee(s) may allocate responsibility for providing and maintaining commonly used equipment and services, including, but not limited to, security systems, fire monitoring and protection services, and waste disposal services. However, the Department may take enforcement action against either the primary licensee or Type S licensee(s) regardless of the allocation of responsibility in the use agreement.
(b) A primary licensee or a Type S licensee is liable for any violation found at the shareduse facility during that licensee’s scheduled occupancy or within that licensee’s designated area. However, a violation of any provision of the Act or this division may be deemed a violation for which each Type S licensee and the primary licensee are responsible. In the event of a recall or embargo of a cannabis product produced at a shared-use facility, the Department, in its sole discretion, may include any or all cannabis products produced at the shared-use facility.
(c) The occupancy schedule and designated area for a Type S licensee shall not be altered without prior notification to the Department. Prior to making any changes to the occupancy schedule or the designated area, written notification that includes the intended changes shall be submitted by email or through the Department’s online licensing system.
Authority: Sections 26013 and 26130, Business and Professions Code. Reference:
Sections 26011.5, 26055 and 26130, Business and Professions Code.
Article 3. Solvent Use and Safety
§17202.1. General Requirements for Extraction and Post-Extraction Processing. (a) A licensed manufacturer that uses a volatile solvent, a flammable liquid, or a solvent that creates an asphyxiant gas shall ensure that the solvent is used in accordance with the requirements of:
(1) Chapter 39 of the California Fire Code;
(2) Title 8, California Code of Regulations, sections 5416-5420, which includes ensuring Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 164 of 216 adequate ventilation and controlling sources of ignition; (3) All Division of Occupational Safety and Health (Cal/OSHA) regulations related to the processing, handling, and storage of the applicable solvent; and (4) All fire, safety, and building code requirements related to the processing, handling, and storage of the applicable solvent or gas.
(b) No volatile solvent extraction or post-extraction processing operations or other closed-loop system operations shall occur in an area zoned as residential.
Authority: Sections 26013 and 26130, Business and Professions Code. Reference:
Sections 26011.5, 26105 and 26130, Business and Professions Code. §17203. Permissible Extractions.
(a) Except as provided in subsection (b), cannabis extraction shall only be conducted using the following methods:
(1) Mechanical extraction;
(2) Chemical extraction using a nonvolatile solvent, as defined in section 15000(uu). (3) Chemical extraction using CO2 gas in a professional closed-loop extraction system. (4) Chemical extraction using a volatile solvent, as defined in section 15000(xxx), in a professional closed-loop extraction system; or
(5) Any other method authorized by the Department pursuant to subsection (b). (b) To request authorization from the Department to conduct cannabis extraction using a method other than those specified in subsections (a)(1) through (4), the applicant or licensee shall submit a detailed description of the extraction method, including any documentation that validates the method and any safety procedures to be utilized to mitigate any risk to public or worker health and safety.
Authority: Sections 26013 and 26130, Business and Professions Code. Reference:
Sections 26011.5 and 26130, Business and Professions Code. §17204. Solvent Requirements.
(a) Any solvents used for extraction or post-extraction processing shall meet the following minimum purity requirements:
(1) Hydrocarbon-based solvents shall be at least 99 percent purity. (2) Nonhydrocarbon-based solvents shall be food-grade.
(3) CO2 gas used for extraction shall be food-grade.
(4) Ethanol shall be food-grade in accordance with 21 CFR, part 184, subpart B, section 184.1293. Ethanol that meets the requirements of food-grade may be combined with another food-grade solvent or a hydrocarbon that meets the requirements of subsection (a)(1) of this section, provided that the use of the solvent mixture is pre-approved by the Department.
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 165 of 216 (5) Water and ice shall be potable.
(6) Dry ice shall be food-grade.
(b) The licensed manufacturer shall maintain copies of the safety data sheets for any chemical solvents used and make these records readily available to employees and to the Department upon request.
(c) The licensed manufacturer shall maintain documentation evidencing the purity of any chemical solvents used and make these records readily available to employees and to the Department upon request.
Authority: Sections 26013 and 26130, Business and Professions Code. Reference:
Sections 26011.5, 26105 and 26130, Business and Professions Code. §17205. Additional Requirements for Ethanol Operations.
A licensed manufacturer that uses ethanol in manufacturing operations for extractions or post-extraction processing shall receive approval for the facility and equipment from the local fire code official prior to commencing operations, if required by local ordinance.
Authority: Sections 26013 and 26130, Business and Professions Code. Reference:
Sections 26011.5 and 26130, Business and Professions Code. §17206. Closed-Loop Extraction System Requirements.
(a) Chemical extractions using CO2; a volatile solvent; or chlorofluorocarbon, hydrocarbon, or other fluorinated gas shall be conducted in a professional closed-loop extraction system designed to recover the solvents. The system shall be commercially manufactured and bear a permanently affixed and visible serial number. The system shall be certified after installation by a California-licensed engineer as commercially manufactured, safe for use with the intended solvent, and built to codes of recognized and generally accepted good engineering practices, such as:
(1) The American Society of Mechanical Engineers (ASME); (2) American National Standards Institute (ANSI);
(3) Underwriters Laboratories (UL); or
(4) The American Society for Testing and Materials (ASTM). (b) The licensed manufacturer shall establish and implement procedures to ensure that the closed-loop extraction system is maintained in accordance with the equipment manufacturer specifications. The licensee shall maintain logs documenting the date(s) of maintenance; description of the maintenance done, including any machine parts that were replaced; and the initials of the employee conducting the maintenance. (c) The certification document required pursuant to subsection (a) shall contain the signature and stamp of a California-licensed professional engineer and the serial number of the extraction unit being certified.
(d) The licensed manufacturer shall establish and implement procedures to ensure Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 166 of 216 routine verification that the system is operating in accordance with equipment manufacturer specifications and continues to comply with fire, safety, and building code requirements. The licensed manufacturer shall conduct any verification recommended by the equipment manufacturer. The licensed manufacturer shall maintain logs documenting the date(s) of verification, description of the verification method, and the initials of the employee conducting the verification.
(e) A licensed manufacturer shall establish and implement standard operating procedures, good manufacturing practices, and a training plan prior to using the closedloop system. Any personnel using solvents or gases in a closed-loop system shall have direct access to applicable safety data sheets. Personnel shall be trained on how to use the system and handle and store solvents and gases safely prior to operating the system.
The training shall be documented in accordance with section 17211.1. (f) Professional closed-loop systems, other equipment used, the extraction operation, and facilities shall be approved for use by the local fire code official prior to commencing operation of the closed-loop system, if required by local ordinance. (g) The facility shall have a gas detection system that meets the requirements of title 24, California Code of Regulations, sections 3905.1-3905.2. (h) All procedures and logs described in this section shall be in writing and made available to the Department upon request.
Authority: Sections 26013 and 26130, Business and Professions Code. Reference:
Sections 26011.5, 26105 and 26130, Business and Professions Code.
Article 4. Good Manufacturing Practices
§17207. Manufacturing Practices Definitions.
In addition to the definitions in section 26001 of the Act and section 15000 of this division, the following definitions shall govern the construction of this article:
(a) “Allergen cross-contact” means the unintentional incorporation of a food allergen into a cannabis product.
(b) “Component” means any substance or item intended for use in the manufacture of a cannabis product, including those substances or items that are not intended to appear in the finished cannabis product. “Component” includes cannabis, cannabis products used as ingredients, raw materials, other ingredients, and processing aids. (c) “Contact surface” means any surface that contacts cannabis products and cannabis product components and those surfaces from which drainage, or other transfer, onto the cannabis product or cannabis product components, occurs during the normal course of operations. Examples of contact surfaces include containers, utensils, tables, and equipment.
(d) “Easily cleanable” means a characteristic of a surface that allows effective removal of soil, food residue, or other organic or inorganic materials by normal cleaning methods.
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 167 of 216 (e) “Environmental pathogen” means a pathogen capable of surviving and persisting within the manufacturing environment such that cannabis products may be contaminated and may result in illness if consumed or used without treatment to significantly minimize the environmental pathogen. Examples of environmental pathogens include Listeria monocytogenes and Salmonella spp. but do not include the spores of pathogenic sporeforming bacteria. (f) “Hazard” means any biological, chemical, radiological, or physical agent that has the potential to cause illness or injury.
(g) “Holding” means storage of cannabis or cannabis products and includes activities performed incidental to storage of a cannabis product and activities performed as a practical necessity for the distribution of that cannabis product. (h) “Microorganisms” means yeasts, molds, bacteria, viruses, protozoa, and microscopic parasites and includes species that are pathogens. The term “undesirable microorganisms” includes those microorganisms that are pathogens, that subject a cannabis product to decomposition, that indicate that a cannabis product is contaminated with filth, or that otherwise may cause a cannabis product to be adulterated. (i) “Monitor” means to conduct a planned sequence of observations or measurements to assess whether preventive measures are operating as intended. (j) “Pathogen” means a microorganism that can cause illness or injury. (k) “Potable” means water that meets the requirements of Health and Safety Code section 113869.
(l) “Preventive measures” means those risk-based, reasonably appropriate procedures, practices, and processes that a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would employ to significantly minimize or prevent the hazards identified pursuant to a product quality plan as specified in section 17214. (m) “Processing aid” means any substance that is added to a cannabis product during manufacture but is removed in some manner from the cannabis product before it is packaged in its finished form. This includes substances that are converted into constituents normally present in the product, and do not significantly increase the amount of the constituent naturally found in the product. This also includes substances that are added to a product for their technical or functional effect in the processing but are present in the finished product at insignificant levels and do not have any technical or functional effect in that product.
(n) “Qualified individual” means a person who has the education, training, or experience (or a combination thereof) necessary to manufacture quality cannabis products as appropriate to the individual's assigned duties. A qualified individual may be, but is not required to be, an employee of the licensed manufacturer. (o) “Quality control” means a planned and systematic operation or procedure for ensuring the quality of a cannabis product.
(p) “Quality control operation” means a planned and systematic procedure for taking all actions necessary to prevent cannabis product(s) from being adulterated or misbranded.
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 168 of 216 (q) “Quality control personnel” means any person, persons, or group designated by the licensed manufacturer to be responsible for quality control operations. (r) “Raw material” means any unprocessed material in its raw or natural state that is intended to become part of the components of a cannabis product. (s) “Sanitize” means to treat cleaned surfaces by a process that is effective in destroying vegetative cells of pathogens and substantially reducing numbers of other undesirable microorganisms, but without adversely affecting the product or its safety for the consumer.
(t) “Smooth” means any of the following:
(1) A contact surface that is free of pits, pinholes, cracks, crevices, inclusions, rough edges, and other surface imperfections detectable by visual or tactile inspection. (2) A floor, wall, or ceiling having an even or level surface with no roughness or projections that render it difficult to clean.
(u) “Utensil” means an implement, tool, or container used in the storage, preparation, manufacture, or processing of cannabis and cannabis products. In addition to kitchenware, examples of utensils include, but are not limited to, gloves, screens, sieves, implements to create pre-rolls, buckets, and scissors.
(v) “Validate” means obtaining and evaluating scientific and technical evidence that a control measure, combination of control measures, or set of quality control procedures, when properly implemented, is capable of ensuring the quality of a cannabis product or effectively controlling an identified hazard.
(w) “Verification” means the application of methods, procedures, tests, or other evaluations, in addition to monitoring, to determine whether a control measure or combination of control measures is or has been operating as intended and to establish the validity of the quality control procedures.
(x) “Yield” means the quantity of a particular cannabis product expected to be produced at a given step of manufacture or packaging, as identified in the master manufacturing protocol. The expected yield is based upon the quantity of components or packaging to be used, in the absence of any loss or error in actual production. “Actual yield” means the quantity of a particular cannabis product that is actually produced at a given step of manufacture or packaging that is recorded in the batch production record.
Authority: Sections 26013 and 26130, Business and Professions Code. Reference:
Sections 26001 and 26130, Business and Professions Code. §17208. Quality Control Program.
(a) A licensed manufacturer shall establish and implement a quality control program to ensure that cannabis products are not adulterated or misbranded. The quality control program shall describe how the licensee will comply with the following:
(1) Grounds, building, and manufacturing premises standards, as specified in section 17209;
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 169 of 216 (2) Equipment and utensil requirements, as specified in section 17210; (3) Personnel procedures, as specified in section 17211; (4) Cannabis product component procedures, as specified in section 17212; and (5) Manufacturing processes and procedures, as specified in section 17213. (b) The quality control program shall be under the supervision of one or more qualified individuals assigned responsibility for this function.
(c) For purposes of this article, for those requirements that are contained in the Health and Safety Code, use of the term “food” shall include cannabis, cannabis products, components, and contact surfaces.
Authority: Sections 26013 and 26130, Business and Professions Code. Reference:
Sections 26011.5 and 26131, Business and Professions Code. §17209. Grounds, Building, and Manufacturing Premises.
(a) Exterior facility and grounds. A licensed manufacturer shall ensure the facility exterior and grounds under the licensed manufacturer’s control meet the following minimum standards:
(1) Grounds shall be equipped with draining areas in order to prevent pooled or standing water;
(2) Weeds, grass, and vegetation shall be cut within the immediate vicinity of the cannabis manufacturing premises, litter and waste shall be removed, and equipment shall be stored in order to minimize the potential for the grounds to constitute an attractant, breeding place, or harborage for pests;
(3) Roads, yards, and parking lots shall be maintained so that these areas do not constitute a source of contamination in areas where cannabis products are handled or transported;
(4) Openings into the building (such as windows, exhaust fans, ventilation ducts, or plumbing vent pipes) shall be screened, sealed, or otherwise protected to minimize potential for pests to enter the building;
(5) Waste treatment and disposal systems shall be provided and maintained so as to prevent contamination in areas where cannabis products may be exposed to such a system’s waste or waste by-products.
(6) A licensed manufacturer shall implement precautions within the premises, such as inspection or extermination, if the premises is bordered by grounds outside the licensed manufacturer’s control that are not maintained in the manner described in subsections (1) through (5), in order to eliminate any pests, dirt, and filth that pose a source of cannabis product contamination. Any use of insecticide, rodenticide, or other pesticide within the premises shall meet the requirements of Health and Safety Code section 114254.
(b) Interior facility. A licensed manufacturer shall ensure construction, design, and maintenance of the interior of the manufacturing premises as follows:
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 170 of 216 (1) Walls, ceilings, and floors. Walls, ceilings, and floors shall be constructed of material that is smooth, nonporous, easily cleanable, corrosion-resistant, and suitable to the activity that will be conducted. Fixtures, ducts, and pipes shall not pose a source of drip or condensate that may contaminate cannabis, cannabis products, components, contact surfaces, or packaging material.
(2) Lighting. Interior facility lighting shall meet the requirements of the Health and Safety Code section 114252, subdivisions (a)(1) and (3), (b)(3) and (4), and (c). Interior facility lighting shall also meet the requirements for shatter-resistant lighting in Health and Safety Code section 114252.1. The requirements of Health and Safety Code section 114252.1(a), shall also apply to all areas where glass breakage may result in the contamination of exposed cannabis, cannabis products, components, contact surfaces, or packaging material.
(3) Plumbing system and fixtures.
(A) Water supply. Running water shall be supplied as required by Health and Safety Code section 114192 in all areas where required for the manufacturing of cannabis products; in all areas used for the cleaning of equipment, utensils, and packaging materials; and for employee sanitary facilities. Water that contacts cannabis, cannabis products, components, contact surfaces, or packaging materials shall be potable. (B) Plumbing. Plumbing systems shall meet the requirements of Health and Safety Code section 114190.
(C) Sewage disposal. The sewage system shall be maintained and kept in good repair so that it does not pose a potential source of contamination of cannabis, cannabis products, components, contact surfaces, or packaging materials.
(D) Toilet facilities. A licensed manufacturer shall provide employees with access to toilet facilities that meet the requirements of Health and Safety Code section 114250. Toilet facilities shall be kept clean and shall not pose a potential source of contamination of cannabis, components, cannabis products, contact surfaces, or packaging materials. (E) Hand-washing facilities. A licensed manufacturer shall provide hand-washing facilities that meet the requirements of Health and Safety Code sections 113953(a)-(d) and 113953.2.
(F) Waste disposal. A licensed manufacturer shall provide for waste disposal in accordance with Health and Safety Code sections 114244(a) and (c) and 114245.1.
Cannabis waste shall be disposed of in accordance with section 17223. (4) Ventilation. Ventilation systems shall meet the requirements of Health and Safety Code sections 114149 and 114149.3.
(5) Cleaning and maintenance. The premises, including any fixtures, and other physical facilities therein, shall be maintained in a clean and sanitary condition and kept in good repair so as to prevent cannabis products from becoming adulterated, and shall meet the requirements of Health and Safety Code section 114257.1. (A) The premises shall have a janitorial facility that meets the requirements of Health and Safety Code section 114279(a).
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 171 of 216 (B) Cleaning equipment and supplies shall be stored in a manner that meets the requirements of Health and Safety Code section 114281.
(C) Poisonous or toxic materials such as cleaning compounds, sanitizing agents, and pesticide chemicals that are necessary for premises and equipment maintenance and operation shall be handled and stored in a manner that meets the requirements of Health and Safety Code sections 114254.1, 114254.2 and 114254.3.
Authority: Sections 26013 and 26130, Business and Professions Code. Reference:
Sections 26011.5 and 26131, Business and Professions Code. §17210. Equipment and Utensils.
(a) Design and construction. Equipment and utensils shall meet the requirements of Health and Safety Code sections 114130.1, 114130.2, 114130.3, and 114130.4 and shall be used in accordance with their operating instructions to avoid the adulteration of cannabis products with lubricants, fuel, metal fragments, contaminated water, or any other contaminants.
(b) Installation. Equipment shall be installed so as to allow cleaning and maintenance of the equipment and of adjacent spaces. Equipment that is not easily moveable shall meet the requirements of Health and Safety Code section 114169. (c) Cleaning, sanitizing, and maintenance. Equipment and utensils shall be maintained in a clean and sanitary condition and kept in good repair. The quality control program for cleaning, sanitizing, and maintenance of equipment and utensils shall include the following elements, at minimum:
(1) A detailed, written procedure for cleaning, sanitizing, and maintaining (including calibrating) equipment and utensils;
(2) A schedule for cleaning, sanitizing, and maintaining equipment and utensils; (3) A log for documentation of the date and time of maintenance, cleaning, and sanitizing of equipment and utensils; and
(4) A procedure for storing cleaned and sanitized equipment and utensils in a manner to protect the equipment and utensils from contamination.
Authority: Sections 26013 and 26130, Business and Professions Code. Reference:
Sections 26011.5 and 26131, Business and Professions Code. §17211. Manufacturing Personnel.
(a) Licensed manufacturers shall establish and implement procedures for personnel that include, at minimum:
(1) Disease control. Any individual who by medical examination or supervisory observation is shown to have, or appears to have, an illness specified in Health and Safety Code section 113949.2(a) or an open lesion (e.g., boil, sore, cut, rash, or infected wound), unless covered in accordance with the requirements of Health and Safety Code section 113949.2(b), shall be excluded from any manufacturing operations until their Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 172 of 216 health condition is corrected. Personnel shall be instructed to report such health conditions to their supervisors.
(2) Cleanliness. All individuals working in direct contact with cannabis, cannabis products, components, contact surfaces, and packaging materials shall maintain personal cleanliness in order to protect against allergen cross-contact and contamination of cannabis products while on duty. The methods for maintaining personal cleanliness include:
(A) Wearing clean outer clothing to protect against allergen cross-contact and contamination of cannabis, cannabis products, components, contact surfaces, and packaging materials;
(B) Washing hands thoroughly in a hand-washing facility that meets the requirements of section 17209 before starting work, after each absence from a work station, at any time specified in Health and Safety Code section 113953.3, and at any time when the hands may have become soiled or contaminated;
(C) Removing all unsecured jewelry and other objects that might fall into cannabis, cannabis products, components, equipment, or containers. Hand jewelry that cannot be sanitized shall be removed during periods in which cannabis products are manipulated by hand. If such hand jewelry cannot be removed, it shall be covered by material that can be maintained in an intact, clean, and sanitary condition and that effectively protects against contamination by these objects of cannabis, cannabis products, components, contact surfaces, and packaging materials;
(D) Maintaining gloves used in cannabis product handling in an intact, clean, and sanitary condition;
(E) Wearing hair nets, caps, beard covers, or other hair restraints that are designed and worn to prevent hair contact with cannabis, cannabis products, components, contact surfaces, and packaging materials;
(F) Storing clothing and personal belongings in areas separate from those where cannabis products are exposed or where equipment or utensils are washed; and (G) Confining the following activities to areas separate from those where cannabis products may be exposed or where equipment or utensils are washed: eating food, chewing gum, drinking beverages, and using tobacco.
(3) Nothing in this section prohibits a licensed manufacturer from establishing additional precautions to protect against allergen cross-contact and contamination of cannabis, cannabis products, components, contact surfaces, and packaging materials by microorganisms or foreign substances (e.g., perspiration, hair, cosmetics, tobacco, chemicals, and medicines applied to the skin).
(4) The procedures for manufacturing personnel shall be in writing and made available to the Department upon request.
Authority: Sections 26013 and 26130, Business and Professions Code. Reference:
Sections 26011.5 and 26131, Business and Professions Code.
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 173 of 216 §17211.1. Training Program.
(a) A manufacturing licensee shall establish and implement a training program to ensure that all personnel present at the premises are provided information and training that, at minimum, covers the following topics:
(1) Within 30 days of the start of employment:
(A) Health and safety hazards;
(B) Hazards presented by all solvents or chemicals used at the licensed premises as described in the safety data sheet for each solvent or chemical; (C) Emergency response procedures;
(D) Security procedures;
(E) Record keeping requirements; and
(F) Training requirements.
(2) Prior to independently engaging in any cannabis manufacturing process:
(A) An overview of the cannabis manufacturing process and standard operating procedure(s);
(B) Quality control procedures;
(C) Product quality plans developed in accordance with section 17214; (D) Proper and safe usage of equipment or machinery;
(E) Safe work practices applicable to an employee’s job tasks, including appropriate use of any necessary safety or sanitary equipment;
(F) Cleaning and maintenance requirements;
(G) Emergency operations, including shutdown; and
(H) Any additional information reasonably related to an employee’s job duties. (3) Additionally, a manufacturing licensee that produces edible cannabis products shall ensure that all personnel who prepare, handle, or package edible products successfully complete a California food handler certificate course from an entity accredited by the American National Standards Institute (ANSI) within 90 days of commencing employment at the premises and again every three years during employment. A manufacturing licensee shall obtain documentation evidencing the fulfillment of this requirement; (b) A manufacturing licensee shall ensure that all personnel receive annual refresher training to cover, at minimum, the topics listed in subsection (a). This annual refresher training must be completed within 12 months of the previous training completion date. (c) A manufacturing licensee shall maintain a record of training containing, at minimum:
(1) A list of all personnel at the premises including, at minimum, name and job duties of each individual;
(2) Documentation of training topics and dates of training completion, including refresher training, for all personnel;
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 174 of 216 (3) The signatures of each individual and the licensee verifying receipt and understanding of each training or refresher training completed by the individual; and (4) Any official documentation attesting to the successful completion of required training by personnel.
(d) A manufacturing licensee may assign responsibility for the training of individual personnel to supervisory personnel. Assigned supervisory personnel must have the education, training, or experience (or a combination thereof) necessary to ensure the production of quality cannabis products by all personnel. The assigned training personnel shall sign and date a document on an annual basis attesting that they received and understands all information that will be provided to personnel in the training program.
This documentation shall be maintained as part of the record requirements in subsection (c).
Authority: Sections 26013 and 26130, Business and Professions Code. Reference:
Sections 26011.5, 26130 and 26160, Business and Professions Code. §17212. Cannabis Product Components.
(a) In order to prevent adulteration of cannabis products, licensed manufacturers shall establish and implement written policies and procedures to ensure and maintain the quality of product components.
(b) Components are subject to the following minimum requirements:
(1) Components that are food must be obtained from a source that complies with federal and state food laws.
(2) Raw materials and other components shall be inspected upon intake to ensure that they are clean and suitable for manufacturing into cannabis products, and shall be stored under conditions that protect against allergen cross-contact and contamination and minimize deterioration.
(3) Raw materials shall be washed or cleaned as necessary to remove soil and other visible contaminants. Water used for washing, rinsing, or conveying cannabis product ingredients shall be potable.
(4) Raw materials and other components shall not contain levels of microorganisms that render the cannabis product injurious to human health, or shall be pasteurized or otherwise treated during manufacturing so that they no longer contain levels of microorganisms that would cause the cannabis product to be adulterated. (5) Raw materials and other components susceptible to contamination with aflatoxin or other natural toxins, pests, or extraneous material shall not exceed generally acceptable limits set by the U.S. Food and Drug Administration in the Defect Levels Handbook (Rev.
February 2005), which is hereby incorporated by reference, before these raw materials or other ingredients are incorporated into cannabis products. (6) Raw materials and other components shall be held in containers designed and constructed to protect against allergen cross-contact or contamination, and shall be held Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 175 of 216 at a temperature and relative humidity and in a manner that prevents the cannabis products from becoming adulterated.
(7) Frozen raw materials and other components shall be kept frozen. If thawing is required prior to use, it shall be done in a manner that prevents the raw materials and other ingredients from becoming adulterated.
(8) Raw materials and other components that are food allergens shall be identified and held in a manner that prevents cross-contact with other raw materials or ingredients. (c) Holding and storage of raw materials and other components shall meet the requirements of Health and Safety Code sections 114047(a) and (b), 114049, and 114051.
(d) The policies and procedures for components shall be in writing and made available to the Department upon request.
Authority: Sections 26013 and 26130, Business and Professions Code. Reference:
Sections 26011.5 and 26131, Business and Professions Code. §17213. Manufacturing Processes and Procedures.
(a) A licensed manufacturer shall implement and maintain the following manufacturing processes and procedures that ensure cannabis product quality:
(1) A product quality plan, as described in section 17214; (2) Master manufacturing protocols, as described in section 17215, for each unique formulation of cannabis product manufactured to ensure only intended components are included and that the cannabis product is packaged and labeled in accordance with product specifications and this division; and
(3) Batch production records, as described in section 17216, to document the production process and, if needed, to verify that the established processes and procedures, including the preventive measures and master manufacturing protocol, were implemented correctly.
(b) All manufacturing records, processes, and procedures shall be in writing and are subject to inspection by the Department, its inspectors and agents.
Authority: Sections 26013 and 26130, Business and Professions Code. Reference:
Sections 26011.5 and 26131, Business and Professions Code. §17214. Product Quality Plan.
(a) A licensed manufacturer shall establish and implement a written product quality plan for each type of product manufactured at the premises. The product quality plan shall address the hazards associated with the premises or the manufacturing process that, if not properly mitigated, may cause the product to be adulterated or misbranded, or may cause the product to fail laboratory testing or quality assurance review.
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 176 of 216 (b) To create the product quality plan, the licensed manufacturer shall conduct a comprehensive assessment of the overall manufacturing process, as follows:
(1) Identify each step from component intake through transfer of product from the premises;
(2) Evaluate the potential risks associated with each step; (3) Identify the preventive measures that shall be taken to mitigate the potential risks identified;
(4) Identify the methods to evaluate and monitor the effectiveness of the preventive measures; and
(5) Identify any action to take if a preventive measure was unsuccessful. (c) The licensed manufacturer shall evaluate the following potential risks to cannabis product quality that could be introduced during manufacturing operations:
(1) Biological hazards, including microbiological hazards; (2) Chemical hazards, including radiological hazards, pesticide contamination, solvent or other residue, natural toxins, decomposition, or allergens; (3) Physical hazards, such as stone, glass, metal fragments, hair, or insects; and (4) Process failures that may lead to product contamination, allergen cross-contact, packaging errors, labeling errors, or other errors affecting cannabis product quality. (d) The licensed manufacturer shall identify and implement the preventive measure(s) necessary to mitigate each potential risk identified pursuant to subsection (c). Examples of preventive measures include, but are not limited to:
(1) Cleaning and sanitizing of equipment and utensils to mitigate against risk of microbiological hazards;
(2) Conducting in-house testing of raw cannabis to mitigate against the risk of pesticide contamination;
(3) Establishing an allergen control program to ensure that allergen cross-contact does not occur between product types; and
(4) Implementing procedures to ensure homogeneity of cannabinoids into a cannabis product to mitigate against the risk of a non-homogeneous product. (e) The licensed manufacturer shall identify and implement methods to evaluate and monitor the effectiveness of the preventive measures in mitigating the potential risks identified in subsection (c). Methods for evaluation and monitoring of preventive measures include, but are not limited to, the following:
(1) Review of test results conducted to determine contamination such as pesticide residue;
(2) Maintaining and reviewing cleaning, sanitizing, or maintenance logs to verify such actions have been taken;
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 177 of 216 (3) Conducting environmental testing to determine if equipment or utensils are contaminated with pathogens; and
(4) Monitoring the temperature of raw materials that need to be held below 41 degrees Fahrenheit to prevent microbial contamination.
(f) The licensed manufacturer shall identify actions to be taken if the evaluation and monitoring of the preventive measure indicates that a risk was not properly mitigated.
The corrective action shall be specific to the type of product under evaluation and the specific risk to be mitigated. Examples of corrective actions include, but are not limited to:
(1) Destruction of product components or finished manufactured cannabis product; (2) Further manufacturing of cannabis extract to remove impurities; and (3) Reworking the unfinished product to further homogenize the cannabinoids. (g) The licensed manufacturer shall maintain the product quality plans and documentation of preventive measures, monitoring results, and corrective actions and make the records available to the Department upon the Department’s request, including during the Department’s onsite inspection of the premises. Nothing in this chapter requires the disclosure of product quality plans other than to the Department and its inspectors and agents. The licensee may consider the product quality plan subject to trade secret protection.
Authority: Sections 26013 and 26130, Business and Professions Code. Reference:
Sections 26011.5 and 26131, Business and Professions Code. §17215. Master Manufacturing Protocol.
(a) A licensed manufacturer shall establish and follow a written master manufacturing protocol for each unique formulation of cannabis product manufactured, and for each batch size, in order to mitigate the potential for adulteration through incorporation of incorrect amounts of cannabinoids, unintended ingredients, or hazards identified in the product quality plan; the potential for misbranding through incorporation of ingredients not identified on the label or mislabeling of the product; and to ensure uniformity in finished batches and across all batches produced.
(b) The master manufacturing protocol shall include:
(1) The name and intended cannabinoid concentration(s) of the cannabis product to be manufactured;
(2) A complete list of components to be used;
(3) The weight or measure of each component to be used. The master manufacturing protocol for any given product may include the ability to adjust the weight or measure of cannabinoid-containing ingredients in order to account for the variability of cannabinoid content in harvest batches;
(4) The identity and weight or measure of each ingredient that will be declared on the ingredients list of the cannabis product;
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 178 of 216 (5) The expected yield of the finished manufactured cannabis product, based upon the quantity of components or packaging to be used in the absence of any loss or error in actual production, and the maximum and minimum percentages of expected yield beyond which a deviation investigation of a batch will be necessary, material review will be conducted, and a decision on the disposition of the product will be made; (6) A description of packaging and a representative label, or a cross-reference to the physical location of the actual or representative label; (7) The expected number of packages and labels to be used, if the cannabis product will leave the manufacturing premises in final form;
(8) Written instructions for each point, step, or stage in the manufacturing process; and (9) Written instructions for any action to mitigate risk(s) identified in the product quality plan.
(c) Master manufacturing protocols shall be in writing and made available to the Department upon request.
(d) Nothing in this chapter requires disclosure of the master manufacturing protocol to any person other than the individuals conducting activities that utilize the protocol or to the Department and its inspectors and agents. The licensee may consider the master manufacturing protocol subject to trade secret protection.
Authority: Sections 26013 and 26130, Business and Professions Code. Reference:
Sections 26011.5 and 26131, Business and Professions Code. §17216. Batch Production Record.
(a) A licensed manufacturer shall prepare a written batch production record every time a batch of a cannabis product is manufactured or a batch of cannabis or cannabis product is remediated. The batch production record shall accurately follow the appropriate master manufacturing protocol, and each step of the protocol shall be performed in the production of the batch.
(b) The batch production record shall document complete information relating to the production and control of each batch, including all of the following details:
(1) The UID and the batch or lot number of the finished batch of cannabis product and the UIDs of all cannabis or cannabis products used in the batch; (2) The specific equipment and processing lines used in producing or remediating the batch;
(3) The identity and weight or measure of each component used; (4) A statement of the actual yield and the percentage difference from expected yield at appropriate phases of manufacturing as identified in the master manufacturing protocol; (5) The actual results obtained during any monitoring operation, if the product quality plan identifies any monitoring needed to ensure product safety; Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 179 of 216 (6) Documentation, at the time of performance, of the manufacture of the batch, including:
(A) The date on which each step of the master manufacturing protocol was performed; and
(B) The initials of the person(s) performing each step; (7) An actual or representative label or other identification of the label to be used for the cannabis product;
(8) The actual quantity of the packaging and labels used, and the difference from the expected number to be used, if the cannabis product will leave the manufacturing premises as a final form cannabis good;
(9) Documentation, at the time of performance, that quality control personnel:
(A) Reviewed the batch production record;
(B) Reviewed all required monitoring operation(s);
(C) Reviewed the results of all tests and examinations, including tests and examinations conducted on components, finished batches of cannabis product, and packaged and labeled cannabis products; and
(D) Either approved and released, or rejected, the finished cannabis product, including any remediated, repackaged or relabeled cannabis product; (10) Documentation, at the time of performance, of any investigation identified in the product quality plan or master manufacturing protocol, including investigations into deviations from the expected yield or package and label count. (c) The batch production record shall:
(1) Contain the actual values and observations obtained during monitoring and, as appropriate, during verification activities;
(2) Be accurate, indelible, and legible;
(3) Be created concurrently with performance of the activity documented; (4) Be as detailed as necessary to provide a history of work performed; and (5) Include the following information:
(A) The license number or premises address of the facility at which the manufacturing occurred;
(B) The date each step was performed;
(C) The signature or initials of the person performing the activity; and (D) The identity of the product, the UID, and the batch or lot number.
Authority: Sections 26013 and 26130, Business and Professions Code. Reference:
Sections 26011.5 and 26131, Business and Professions Code.
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 180 of 216 §17217. Standard Operating Procedures.
(a) A licensed manufacturer shall establish and maintain written standard operating procedures that are easily accessible to onsite personnel. The standard operating procedures shall, at minimum, include the following:
(1) Policies or procedures developed in accordance with the security plan required by section 15042.1;
(2) Emergency response procedures, including safety data sheets for any chemicals onsite;
(3) Policies and procedures developed in accordance with section 17206; (4) Policies and procedures developed in accordance with this article; (5) Procedures for complying with the track and trace requirements established in article 6 of chapter 1; and
(6) Cannabis waste management procedures in compliance with section 17223. (b) Procedures shall be written in English but may be made available in other languages, as necessary for the licensee’s personnel.
Authority: Sections 26013 and 26130, Business and Professions Code. Reference:
Sections 26011.5, 26130 and 26160, Business and Professions Code. §17218. Inventory Control – Cannabis and Cannabis Products. (a) A licensed manufacturer shall establish and implement a written inventory control plan capable of tracking the location and disposition of all cannabis and cannabis products at the licensed premises.
(b) A licensed manufacturer shall reconcile the on-hand inventory of cannabis and cannabis products at the licensed premises with the records in the track and trace system at least once every thirty (30) calendar days.
(c) If a licensed manufacturer finds a discrepancy between the on-hand inventory and the track and trace system, the licensee shall conduct an audit. (d) If the inventory reconciliation conducted pursuant to subsection (b) or the audit conducted pursuant to subsection (c) reveals a discrepancy that is more than five percent of the documented inventory, the licensed manufacturer shall notify the Department within 24 hours of the discovery.
Authority: Sections 26013 and 26130, Business and Professions Code. Reference:
Sections 26011.5 and 26130, Business and Professions Code.
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 181 of 216 Article 5. Special Requirements
§17219. Juice Manufacturing.
Manufacturers of cannabis juice or cannabis-infused juice or beverages shall prepare and implement a written juice hazard analysis and critical control plan in accordance with the requirements of title 21, Code of Federal Regulations, Part 120, subpart A, section 120.8 and subpart B, section 120.24, (Rev. January 2001), which are hereby incorporated by reference.
Authority: Sections 26013 and 26130, Business and Professions Code. Reference:
Sections 26011.5 and 26131, Business and Professions Code. §17220. Dried Meat Manufacturing.
Manufacturing of cannabis-infused dried meat products shall be conducted in accordance with the United States Department of Agriculture FSIS Compliance Guideline for Meat and Poultry Jerky Produced by Small and Very Small Establishments: 2014 Compliance Guideline (Rev. 2014), which is hereby incorporated by reference. Meat for manufacturing into dried meat products shall be acquired from a commercially-available source.
Authority: Sections 26013 and 26130, Business and Professions Code. Reference:
Sections 26011.5 and 26131, Business and Professions Code.
Chapter 9. Other Responsibilities
§17221. Weighing Devices and Weighmasters.
(a) A licensee shall use weighing devices approved, tested, and sealed in accordance with the requirements in Business and Professions Code, division 5, chapter 5 (commencing with section 12500) and its implementing regulations, and registered with the county sealer consistent with Business and Professions Code, division 5, chapter 2 (commencing with section 12240) and its implementing regulations whenever:
(1) Cannabis or cannabis product is bought or sold by weight or count; (2) Cannabis or cannabis product is packaged for sale by weight or count; (3) Cannabis or cannabis product is weighed or counted for entry into the track and trace system; and
(4) The weighing device is used for commercial purposes as defined in Business and Professions Code section 12500.
(b) Whenever the licensee is determining the weight, measure, or count of cannabis and cannabis products for the purposes specified in subsection (a), the weight, measure, or count shall be determined by a licensed weighmaster in compliance with the requirements of Business and Professions Code, division 5, chapter 7 (commencing with section 12700).
(c) A licensee shall obtain a weighmaster certificate that complies with the requirements Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 182 of 216 of Business and Professions Code, division 5, chapter 7 (commencing with section 12700) whenever:
(1) Payment for the cannabis or cannabis product is dependent upon the quantity determined by the weighmaster; or
(2) Payment for service or processing of the cannabis or cannabis product is dependent upon the quantity determined by the weighmaster.
(d) The weighmaster certificate shall not be required when cannabis or cannabis products are weighed or counted for entry into the track and trace system. (e) In any county in which a county sealer refuses or is not required to approve, register, test, and seal weighing devices used by a licensee, the licensee may have a service agency registered pursuant to Business and Professions Code, division 5, chapter 5.5 perform testing of a weighing device consistent with the requirements in title 4, California Code of Regulations, section 4070. The licensee shall keep a copy of the registered service agency’s written inspection report attesting to the accuracy of the device for each device operated by the licensee.
Authority: Sections 26013 and 26130, Business and Professions Code. Reference:
Sections 26011.5 and 26060, Business and Professions Code. §17223. Waste Management.
(a) A licensee shall dispose of all waste in accordance with the Public Resources Code and any other applicable state and local laws. It is the responsibility of the licensee to properly evaluate waste to determine if it should be designated and handled as a hazardous waste, as defined in Public Resources Code section 40141. (b) A licensee shall establish and implement a written cannabis waste management plan that describes the method or methods by which the licensee will dispose of cannabis waste, as applicable to the licensee’s activities. A licensee shall dispose of cannabis waste using only the following methods:
(1) On-premises composting of cannabis waste.
(2) Collection and processing of cannabis waste by a local agency, a waste hauler franchised or contracted by a local agency, or a private waste hauler permitted by a local agency in conjunction with a regular organic waste collection route. (3) Self-haul cannabis waste to one or more of the following:
(A) A manned, fully permitted solid waste landfill or transformation facility; (B) A manned, fully permitted composting facility or manned composting operation; (C) A manned, fully permitted in-vessel digestion facility or manned in-vessel digestion operation;
(D) A manned, fully permitted transfer/processing facility or manned transfer/processing operation;
(E) A manned, fully permitted chip and grind operation or facility; or Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 183 of 216 (F) A recycling center as defined in title 14, California Code of Regulations, section 17402.5(d) that meets the following:
(i) The cannabis waste received shall contain at least ninety (90) percent inorganic material;
(ii) The inorganic portion of the cannabis waste is recycled into new, reused, or reconstituted products that meet the quality standards necessary to be used in the marketplace; and
(iii) The organic portion of the cannabis waste shall be sent to a facility or operation identified in subsections (b)(3)(A)-(E).
(4) Reintroduction of cannabis waste back into agricultural operation through onpremises organic waste recycling methods including, but not limited to, tilling directly into agricultural land and no-till farming.
(c) The licensee shall maintain any cannabis waste in a secured waste receptacle or secured area on the licensed premises until the time of disposal. Physical access to the receptacle or area shall be restricted to the licensee, employees of the licensee, the local agency, waste hauler franchised or contracted by the local agency, or private waste hauler permitted by the local agency only. Nothing in this subsection prohibits licensees from using a shared waste receptacle or area with other licensees, provided that the shared waste receptacle or area is secured and access is limited as required by this subsection.
(d) A licensee that disposes of waste through an entity described in subsection (b)(2) shall do all of the following:
(1) Maintain and make available to the Department upon request the business name, address, contact person, and contact phone number of the entity hauling the waste; and (2) Obtain documentation from the entity hauling the waste that evidences subscription to a waste collection service.
(e) If a licensee is self-hauling cannabis waste as allowed by the local jurisdiction, the licensee shall be subject to all of the following requirements:
(1) Self-hauled cannabis waste shall only be transported by the licensee or its employees;
(2) Self-hauled cannabis waste shall only be transported to a facility specified in subsection (b)(3); and
(3) The licensee or its employee who transports the waste shall obtain for each delivery of cannabis waste a copy of a certified weight ticket or receipt from the solid waste facility.
(f) A batch of cannabis or cannabis products that is being disposed of because the batch has failed internal quality testing, quality assurance review by a distributor, or regulatory compliance testing shall comply with the following additional requirements:
(1) All cannabis or cannabis products in the batch shall be rendered unusable prior to disposal;
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 184 of 216 (2) Rendering of the cannabis or cannabis products shall be done under video surveillance, unless the rendering is performed by a licensee engaging in cultivation activities on a licensed premises authorized exclusively for cultivation activities or the cultivation area of a licensed microbusiness premises; and (3) The reason for disposal and the disposition of the batch shall be noted in the track and trace system.
Authority: Sections 26013 and 26130, Business and Professions Code. Reference:
Sections 26011.5 and 26130, Business and Professions Code. §17225. Product Complaints.
(a) A licensee shall review all product complaints made to the licensee to determine whether the complaints involve possible misbranding or adulteration of a cannabis good, and shall investigate the complaints to the extent practicable based on the information received and the records the licensee is required to maintain. (b) For purposes of this section, “product complaint” means any written, electronic, or oral communication received by a licensee that contains any allegation expressing concern, for any reason, with the quality of a cannabis good. Examples of product complaints may include, but are not limited to: foul odor, caused illness or injury, foreign material in a cannabis product container, improper packaging, mislabeling, cannabis products that contain an incorrect concentration of cannabinoids, and cannabis products that contain an unidentified ingredient, or any form of contaminant. (c) The licensee shall maintain written records for every product complaint received and any subsequent investigation. The records shall include:
(1) The name and description of the cannabis good;
(2) The batch number or UID of the cannabis good, if available; (3) The date the complaint was received and the name, address, and telephone number of the complainant, if available;
(4) The nature of the complaint including, if known, how the product was used; (5) The reply to the complainant, if any;
(6) The findings of the investigation or follow-up action taken when an investigation is performed;
(7) The basis for any determination not to conduct an investigation, if applicable; and (8) The notification to the licensee that made the cannabis good, if applicable. (d) The licensee shall conduct a recall, as specified in section 17226, when the investigation evidences adulteration or misbranding.
Authority: Sections 26013 and 26130, Business and Professions Code. Reference:
Sections 26011.5 and 26131, Business and Professions Code.
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 185 of 216 §17226. Voluntary Recalls.
(a) Licensees shall establish and implement written procedures for recalling cannabis goods that are determined to be misbranded or adulterated. These procedures shall include:
(1) Factors that necessitate a recall;
(2) Personnel responsible for implementing the recall procedures; and (3) Notification protocols, including:
(A) A mechanism to notify all customers that have, or could have, obtained the cannabis goods, including communication and outreach via media, as necessary and appropriate; (B) A mechanism to notify any licensees that supplied or received the recalled cannabis goods; and
(C) Instructions to the general public and other licensees for the return or destruction of the recalled cannabis goods; and
(4) Procedures for the collection and destruction of any recalled cannabis goods. These procedures shall meet the following requirements:
(A) All recalled cannabis goods that are intended to be destroyed shall be quarantined for a minimum of 72 hours, unless a longer holding time is requested by the Department.
The licensee shall affix to the recalled cannabis goods any bills of lading, shipping manifests, or other similar documents with the cannabis goods information and weight.
The cannabis goods held in quarantine shall be subject to auditing by the Department. (B) Following the quarantine period, the licensee shall render the recalled cannabis goods unusable and dispose of them in accordance with section 17223. (b) In addition to the tracking requirements set forth in section 15049, a licensee shall use the track and trace system and onsite documentation to ensure that recalled cannabis goods intended for destruction are identified, weighed, and tracked while on the licensed premises and when disposed of in accordance with this section. For recalled cannabis goods, the licensee shall enter the following details into the track and trace system: the weight and count of the cannabis goods, reason for destruction, and date the quarantine period will begin.
(c) The licensee shall notify the Department of any recall within 24 hours of initiating the recall.
(d) A licensed manufacturer may submit a remediation plan to the Department in accordance with the section 17305. If the remediation plan is not approved by the Department, the cannabis goods shall be destroyed pursuant to the procedures required by subsection (a)(4).
Authority: Sections 26013 and 26130, Business and Professions Code. Reference:
Sections 26039.1 and 26039.6, Business and Professions Code.
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 186 of 216 §17227. Mandatory Recalls.
(a) The Department may require licensees to conduct a recall of a cannabis good that is adulterated or misbranded in accordance with Business and Professions Code section 26039.1.
(b) The licensee shall conduct the mandatory recall in the same manner as a voluntary recall as provided in section 17226.
Authority: Sections 26013 and 26130, Business and Professions Code. Reference:
Sections 26039.1 and 26039.6, Business and Professions Code.
Chapter 10. Cannabis and Cannabis Products
Article 1. Standards for Manufactured Cannabis Products §17300. Prohibited Products.
The following types of products shall not be sold as cannabis products:
(a) Alcoholic beverages, as defined in Business and Professions Code section 23004.
This prohibition does not apply to tinctures that meet the requirements of section 17303; (b) Any product containing any non-cannabinoid additive that would increase potency, toxicity, or addictive potential, or that would create an unsafe combination with other psychoactive substances. Prohibited additives include, but are not limited to, nicotine and caffeine. This prohibition shall not apply to products containing naturally-occurring caffeine, such as coffee, tea, or chocolate;
(c) Any cannabis product that must be held at or below 41 degrees Fahrenheit to keep it safe for human consumption, including, but not limited to, cream- or custard-filled pies; pies or pastries consisting in whole or in part of milk or milk products, or eggs; and meatfilled pies or pastries. This prohibition shall not apply to juices or beverages that need to be held below 41 degrees Fahrenheit if the juice or beverage was processed in accordance with section 17219, or to infused butter manufactured as permitted by subsection (g);
(d) Any thermally-processed low-acid cannabis product packed in a hermetically sealed container that, if it did not contain cannabis, would be subject to the manufacturing requirements of title 21, Code of Federal Regulations, part 113; (e) Any acidified cannabis product that, if it did not contain cannabis, would be subject to the manufacturing requirements of title 21, Code of Federal Regulations, part 114; (f) Any juice that is not shelf-stable or that is not processed in accordance with section 17219;
(g) Dairy products of any kind, as prohibited by Business and Professions Code section 26001(u), except butter purchased from a licensed milk products plant or retail location that is subsequently infused or mixed with cannabis may be sold as a cannabis product; (h) Meat products other than dried meat products prepared in accordance with section 17220;
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 187 of 216 (i) Seafood products of any kind;
(j) Any product that is manufactured by application of cannabinoid concentrate or extract to commercially available candy or snack food items without further processing of the product. Commercially available candy or snack food items may be used as ingredients in a cannabis product, provided that they are used in a way that renders them unrecognizable as the commercially available items, and the label, including the ingredient list, does not note that the final cannabis product contains the commercially available item;
(k) Any cannabis product that the Department determines, on a case-by-case basis, is attractive to children, as specified in section 17408;
(l) Any cannabis product that the Department determines, on a case-by-case basis, is easily confused with commercially available foods that do not contain cannabis; or (m) Any cannabis product in the shape of, or imprinted with the shape, either realistic or caricature, of a human being, animal, insect, or fruit.
Authority: Sections 26013 and 26130, Business and Professions Code. Reference:
Sections 26011.5 and 26130, Business and Professions Code. §17301. Requirements for Edible Cannabis Products.
(a) Except for cannabis, cannabis products, or terpenes, no ingredient or component shall be used in the manufacture of an edible cannabis product unless that ingredient or component is permitted by the United States Food and Drug Administration for use in food or food manufacturing, as specified in Substances Added to Food in the United States, available at
https://www.accessdata.fda.gov/scripts/fdcc/index.cfm?set=FoodSubstances or is Generally Recognized as Safe (GRAS) under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (codified in 21 U.S.C. 321(s) and 21 U.S.C. 348). (b) Edible cannabis products that consist of more than a single serving shall be either:
(1) Scored or delineated to indicate one serving, if the edible cannabis product is in solid form. For purposes of this section, “delineated” includes directly marking the product to indicate one serving or providing a means by which a consumer can accurately identify one serving; or
(2) If the edible cannabis product is not in solid form, packaged in a manner such that a single serving is readily identifiable or easily measurable. (c) An edible cannabis product consisting of multiple servings shall be homogenized so that each serving contains the same concentration of THC.
Authority: Sections 26013 and 26130, Business and Professions Code. Reference:
Sections 26011.5 and 26130, Business and Professions Code.
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 188 of 216 §17302. Additional Requirements for Topical Cannabis Products. (a) Except for cannabis, cannabis concentrate, or terpenes, topical cannabis products shall only contain ingredients permitted for cosmetic manufacturing in accordance with title 21, Code of Federal Regulations, part 700, subpart B (section 700.11 et seq.) (Rev.
April 2020), which is hereby incorporated by reference.
Authority: Sections 26013 and 26130, Business and Professions Code. Reference:
Section 26011.5, Business and Professions Code.
§17303. Orally Consumed Products Containing Alcohol.
(a) Any orally consumed product that contains more than 0.5% alcohol by volume as an ingredient, and is not otherwise an alcoholic beverage as defined in Business and Professions Code section 23004, shall be packaged in a container no larger than two (2) fluid ounces and shall include a calibrated dropper or other similar device capable of accurately measuring servings.
Authority: Sections 26013 and 26130, Business and Professions Code. Reference:
Section 26011.5, Business and Professions Code.
Article 2. Cannabinoid Concentration Limits
§17304. THC Concentration Limits.
(a) An edible cannabis product shall not contain more than:
(1) 10 milligrams THC per serving; and
(2) 100 milligrams THC per package.
(b) Notwithstanding subsection (a), a package containing an edible product that is an orally dissolving product, such as sublingual lozenges or mouth strips, may contain up to 500 milligrams THC per package, if:
(1) The cannabis product consists of discrete servings of no more than 10 milligrams THC per piece;
(2) The cannabis product is labeled “FOR MEDICAL USE ONLY;” and (3) The cannabis product is only available for sale to a medicinal-use patient. (c) A topical cannabis product or a cannabis concentrate shall not contain more than 1,000 milligrams THC per package.
(d) Notwithstanding subsection (c), a topical cannabis product or a cannabis concentrate may contain more than 1,000 milligrams THC per package, but not more than 2,000 milligrams THC per package, if the product is labeled “FOR MEDICAL USE ONLY” and is only available for sale to a medicinal-use patient.
Authority: Sections 26013 and 26130, Business and Professions Code. Reference:
Sections 26011.5, 26120 and 26130, Business and Professions Code.
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 189 of 216 Article 3. Failed Product Batches
§17305. Failed Product Batches.
(a) A finished cannabis product batch that fails any regulatory compliance laboratory testing requirement established in this division shall be destroyed unless:
(1) The cannabis product batch may be remediated by relabeling pursuant to subsection (d); or
(2) A corrective action plan for remediation is approved by the Department pursuant to subsection (e).
(b) Remediation of a failed product batch or the use of a harvest batch that has failed any regulatory compliance laboratory test shall comply with the requirements and procedures established by the Department in section 15727, in addition to the requirements of this article.
(c) Except as provided in subsections (d) and (f), edible cannabis products that fail regulatory compliance laboratory testing shall not be remediated and shall be destroyed.
If any edible cannabis product that has failed regulatory compliance laboratory testing is remediated or otherwise mixed with another batch of cannabis product in violation of this section, such action shall render the final cannabis product adulterated, regardless of the defect level of the final cannabis product.
(d) A cannabis product batch that fails regulatory compliance laboratory testing for cannabinoid or terpenoid content may be remediated by relabeling the product with the correct information from the laboratory certificate of analysis, provided that the THC limits in section 17304 are met. In addition, the following conditions apply:
(1) The manufacturer licensee shall notify the Department within 3 business days of notification by a distributor that the product failed cannabinoid content testing and is required to be relabeled.
(2) Notification shall be given to the Department by email and shall include a copy of the certificate of analysis for the batch and the name and license number of the licensee relabeling the product.
(e) Except as provided in subsection (d), a cannabis product batch or a harvest batch that fails regulatory compliance laboratory testing or quality assurance review shall not be remediated unless the Department has approved a corrective action plan submitted by the manufacturer licensee. The corrective action plan shall include, at minimum, a description of how the product or harvest batch will be remediated so that the product or harvest batch, or any product produced therefrom, will meet all regulatory compliance laboratory testing and quality assurance requirements. Edible cannabis products may only be remediated by relabeling or repackaging as provided in subsection (f). Corrective action plans will be reviewed by the Department on a case-by-case basis. (f) Edible cannabis products that fail regulatory compliance laboratory testing because the per-package limit of THC has been exceeded may be remediated by repackaging under the following conditions:
(1) The Department has approved a corrective action plan for repackaging the product; Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 190 of 216 (2) The product batch is returned to the manufacturer that packaged the product; (3) The product itself is not altered in any way; and
(4) The product is labeled to accurately state the contents. (g) All remediation of harvest or product batches shall be documented in the batch production records. Remediated products, harvest batches, or products produced therefrom shall be tested and undergo quality assurance review in accordance with the requirements established by the Department in chapter 2 of this division prior to retail sale.
Authority: Sections 26013 and 26130, Business and Professions Code. Reference:
Section 26131, Business and Professions Code.
Chapter 11. Labeling and Packaging Requirements
Article 1. Bulk Cannabis or Cannabis Products, Immature Plants, and Seeds §17398. Bulk Cannabis or Cannabis Products.
(a) For purposes of this section, “bulk cannabis or cannabis products” means cannabis or cannabis products transferred between licensees for the purpose of further processing and/or packaging.
(b) The packaging used to transport bulk cannabis or cannabis products shall protect the cannabis or cannabis products from contamination and shall not expose the cannabis or cannabis products to any toxic or harmful substance.
(c) Packages of bulk cannabis or cannabis products shall be labeled with the following:
(1) The type or common name of the cannabis or cannabis products contained therein; (2) The UID assigned to the cannabis or cannabis products; (3) The ingredients of the cannabis products, including a list of any allergens present as described in section 17406(a)(6); and
(4) The net weight or count of the cannabis or cannabis products.
Authority: Sections 26013 and 26130, Business and Professions Code. Reference:
Section 26120, Business and Professions Code.
§17399. Immature Plants.
(a) Immature plants to be sold at retail are not required to be placed in child-resistant or tamper-evident packaging prior to sale.
(b) Immature plants shall be labeled with the following:
(1) The legal business name, or any name listed on the license certificate, of the licensed nursery that cultivated the immature plant, and its contact number or website address; (2) The strain name; and
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 191 of 216 (3) The statement: “This plant has not been tested in accordance with the Medicinal and Adult-Use Cannabis Regulation and Safety Act.”
Authority: Section 26013, Business and Professions Code. Reference: Sections 26070, 26100 and 26120, Business and Professions Code.
§17400. Seeds.
(a) Packages of seeds are not required to be placed in child-resistant packaging prior to sale.
(b) Packages of seeds to be sold at retail shall be labeled with the following:
(1) The legal business name, or any name listed on the license certificate, of the licensed nursery that cultivated the seeds, and its contact number or website address; (2) The strain name(s);
(3) Either the weight or count of seeds in the package; (4) The universal symbol described in section 17410; and (5) The statement: “These seeds have not been tested in accordance with the Medicinal and Adult-Use Cannabis Regulation and Safety Act.”
Authority: Sections 26013 and 26130, Business and Professions Code. Reference:
Section 26130, Business and Professions Code.
Article 2. Cannabis Products Released from Manufacturing §17401. Release to Distributor as Finished Product.
(a) Prior to release of a manufactured cannabis product to a distributor for purposes of compliance testing and retail sale, a licensed manufacturer shall ensure that the product is labeled and packaged in its final form for retail sale. (b) Notwithstanding subsection (a), a product label may exclude labeling of cannabinoid content if the cannabinoid content is to be added to the label at the distribution premises after issuance of a Certificate of Analysis in accordance with section 17407.
Authority: Sections 26013 and 26130, Business and Professions Code. Reference:
Sections 26011.5 and 26130, Business and Professions Code.
Article 3. Labeling Requirements
§17402. General Provisions.
(a) Any information required to be listed on a label shall be written in English. (b) A label shall be unobstructed and conspicuous so that it can be read by the consumer.
(c) All required label information shall be located on the outside container or wrapper of the finished product to be sold at a retailer, or be easily legible through the outermost Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 192 of 216 container or wrapper. If the immediate container holding the cannabis goods is separable from the outermost packaging, such as a container placed inside of a box, the immediate container shall be labeled with the universal symbol as described in section 17410.
Authority: Sections 26013 and 26130, Business and Professions Code. Reference:
Section 26120, Business and Professions Code.
§17403. Primary Panel Labeling Requirements: Nonmanufactured Cannabis Goods.
(a) The label for a package of nonmanufactured cannabis goods shall include a primary panel that includes the following information in a type size no smaller than 6 point and proportional to the size of the primary panel and container:
(1) The identity of the product;
(2) The net weight of cannabis in the package, listed in both metric and U.S. customary units; and
(3) The universal symbol described in section 17410.
(b) The label for a package of pre-rolls or packaged flower shall include an informational label that includes the following information in a type size no smaller than 6 point and proportional to the size of the informational panel and container:
(1) The UID;
(2) The name of the licensed cultivator or licensee packaging the product (either the legal business name or the registered name under which the business will operate listed on the license certificate) and that licensee’s contact number or website address; (3) The date of packaging for retail sale; and
(4) The following statement in bold print: “GOVERNMENT WARNING: THIS PACKAGE CONTAINS CANNABIS, A SCHEDULE I CONTROLLED SUBSTANCE. KEEP OUT OF REACH OF CHILDREN AND ANIMALS. CANNABIS MAY ONLY BE POSSESSED OR CONSUMED BY PERSONS 21 YEARS OF AGE OR OLDER UNLESS THE PERSON IS A QUALIFIED PATIENT. CANNABIS USE WHILE PREGNANT OR
BREASTFEEDING MAY BE HARMFUL. CONSUMPTION OF CANNABIS IMPAIRS YOUR ABILITY TO DRIVE AND OPERATE MACHINERY. PLEASE USE EXTREME CAUTION.”
(c) Nothing in this section prohibits the inclusion of additional information on the primary panel, provided that the label does not violate the requirements of section 17408. (d) The cannabinoid content for a package of pre-rolls or packaged flower shall be labeled as specified in section 17407.
Authority: Sections 26013 and 26130, Business and Professions Code. Reference:
Section 26120, Business and Professions Code.
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 193 of 216 §17404. Primary Panel Labeling Requirements: Manufactured Cannabis Products. (a) The label for a manufactured cannabis product shall include a primary panel that includes the following information in a type size no smaller than 6 point and proportional to the size of the primary panel and container:
(1) The identity of the product in a text size reasonably proportional to the most prominent printed matter on the panel;
(2) The universal symbol as described in section 17410; and (3) The net weight or volume of the contents of the package, listed in both metric and U.S. customary units.
(b) Nothing in this section prohibits the inclusion of additional information on the primary panel, provided that the label does not violate the requirements of section 17408.
Authority: Sections 26013 and 26130, Business and Professions Code. Reference:
Section 26120, Business and Professions Code.
§17405. Additional Primary Panel Labeling Requirements: Edible Products. (a) In addition to the requirements of section 17404, the primary panel of an edible cannabis product shall include the words “cannabis-infused” or “cannabis infused” immediately above the identity of the product in bold type and a text size larger than the text size used for the identity of the product.
Authority: Sections 26013 and 26130, Business and Professions Code. Reference:
Section 26120, Business and Professions Code.
§17406. Informational Panel Labeling Requirements.
(a) The label for a manufactured cannabis product shall include an informational panel that includes the following:
(1) The name of the licensed manufacturer (either the legal business name or the registered name under which the business will operate listed on the license certificate) that manufactured the cannabis product and the manufacturer’s contact number or website address;
(2) The date the cannabis product was packaged for retail sale; (3) The following statement in bold print: “GOVERNMENT WARNING: THIS PRODUCT CONTAINS CANNABIS, A SCHEDULE I CONTROLLED SUBSTANCE. KEEP OUT OF REACH OF CHILDREN AND ANIMALS. CANNABIS PRODUCTS MAY ONLY BE POSSESSED OR CONSUMED BY PERSONS 21 YEARS OF AGE OR OLDER UNLESS THE PERSON IS A QUALIFIED PATIENT. THE INTOXICATING EFFECTS OF CANNABIS PRODUCTS MAY BE DELAYED UP TO TWO HOURS. CANNABIS USE WHILE PREGNANT OR BREASTFEEDING MAY BE HARMFUL. CONSUMPTION
OF CANNABIS PRODUCTS IMPAIRS YOUR ABILITY TO DRIVE AND OPERATE MACHINERY. PLEASE USE EXTREME CAUTION;”
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 194 of 216 (4) The statement: “FOR MEDICAL USE ONLY” if the package contains an amount of THC that exceeds the level allowed for adult-use cannabis goods, as specified in section 17304;
(5) A list of all product ingredients in descending order of predominance by weight or volume. If any product ingredient contains subingredients, the list shall either:
(A) Include the common name of the ingredient followed by a parenthetical listing of all ingredients in descending order by weight or volume; or (B) List all subingredients as individual ingredients in descending order of predominance; however,
(C) This subsection shall not apply to flavoring, which shall instead comply with title 21, Code of Federal Regulations, Part 101.22 (Rev. April 2020), hereby incorporated by reference;
(6) For cannabis products containing an ingredient, flavoring, coloring, or an incidental additive that bears or contains a major food allergen, the word “contains,” followed by a list of the applicable major food allergens. The list shall conform with the requirements for food allergen labeling set forth in 21 U.S.C. §343(w), paragraph (1)(A) or (1)(B); (7) The names of any artificial colorings contained in the product; (8) For edible cannabis products, the amount, in grams or milligrams, of sodium, sugar, carbohydrates, and total fat per serving;
(9) Instructions for use, such as the method of consumption or application, and any preparation necessary prior to use;
(10) The UID;
(11) The batch or lot number; and
(12) The statement: “KEEP REFRIGERATED” or “REFRIGERATE AFTER OPENING,” as applicable, if the cannabis product is perishable or perishable after opening. (b) The informational panel text shall be in a type size no smaller than 6 point and proportional to the size of the primary panel and container. (c) Except for the information required by subsections (a)(10) and (a)(11), the requirements of subsection (a) may be fulfilled through the use of supplemental labeling, which may include, but is not limited to, a package insert, fold-out or booklet label, or a hanging tag. After December 31, 2021, supplemental labeling may not be used to fulfill the labeling requirement in subsection (a)(1).
(d) Cannabinoid content may be included on the informational panel. Cannabinoid content for manufactured cannabis products shall be labeled as specified in section 17407.
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 195 of 216 (e) Nothing in this section prohibits the inclusion of additional information on the informational panel provided that the label does not violate the requirements of section 17408.
Authority: Sections 26013 and 26130, Business and Professions Code. Reference:
Section 26120, Business and Professions Code.
§17407. Cannabinoid Content Labeling.
(a) Each package for retail sale of cannabis goods shall be labeled with the cannabinoid content on either the primary panel or an informational panel. For manufactured products, cannabinoid content may be included on the label prior to release to a distributor or it may be added to the label at the distribution premises after issuance of a regulatory compliance testing Certificate of Analysis for the batch as described in subsection (d).
(b) Cannabinoid content labeling shall include the following:
(1) For an edible product or a cannabis concentrate for which the manufacturer has established serving designations, THC and CBD content expressed in milligrams per serving and milligrams per package.
(2) For a topical cannabis product or a cannabis concentrate without serving designations, THC and CBD content expressed in milligrams per package. (3) For nonmanufactured cannabis goods, Total THC content expressed as a percentage.
(4) Packages of infused pre-rolls shall be labeled with either:
(A) The cannabinoid content in milligrams; or
(B) The cannabinoid content of the dried flower expressed as a percentage and the added cannabinoid content in milligrams.
(c) Cannabis goods labeled prior to testing must include the items specified in subsection (b), as appropriate to the product. For THC or CBD concentration that is less than two (2) milligrams per serving or per package, the THC or CBD concentration may be stated as “<2 mg per serving” or “<2 mg per package.”
(d) Cannabis goods labeled at the distribution premises after issuance of the Certificate of Analysis shall comply with the following:
(1) Each package of cannabis goods shall be labeled with the cannabinoid content as specified in subsection (b) that is indicated on the Certificate of Analysis, as well as any other cannabinoid that is five (5) percent or greater of the total cannabinoid content; (2) Labeled cannabinoid content shall reflect the amount indicated on the Certificate of Analysis. The amount may be rounded to the nearest whole number, except that packages shall not be labeled with an amount greater than the allowable THC limits. If the THC or CBD content of a manufactured cannabis product is indicated on the Certificate of Analysis as “Not Detected” or “<LOQ,” the cannabinoid content shall be labeled as “0 mg” or “<2 mg;”
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 196 of 216 (3) The cannabinoid content label shall be affixed to the outermost packaging of the cannabis goods and shall not obscure any other label information. (e) Nothing in this section precludes the labeling of terpenes or additional cannabinoid content on the cannabis goods, provided that the information is verified by the Certificate of Analysis.
Authority: Sections 26013 and 26130, Business and Professions Code. Reference:
Section 26120, Business and Professions Code.
§17408. Labeling Restrictions.
(a) Cannabis goods labeling shall not contain any of the following:
(1) The name of a California city, county, or city and county, including any similar name that is likely to mislead consumers as to the origin of the product, unless one hundred percent of the cannabis contained in the product was grown in that city, county, or city and county. For purposes of this subsection, a cannabis plant is considered to have been grown within a city, county, or city and county of origin if the plant was cultivated within that boundary starting from the time the plant was no taller or wider than 18 inches. (2) Content that is, or is designed to be, attractive to individuals under the age of 21, as specified in section 15040(a)(2) and (3).
(3) Any health-related statement that is untrue or misleading. Any health-related statement must be supported by the totality of publicly available scientific evidence (including evidence from well-designed studies conducted in a manner which is consistent with generally recognized scientific procedures and principles), and for which there is significant scientific agreement among experts qualified by scientific training and experience to evaluate such claims.
(4) If the product is an edible cannabis product, a picture of the product contained therein.
(5) Any information that is false or misleading. For purposes of this section, false and misleading information includes, but is not limited to:
(A) Any statement or indication that the cannabis or cannabis product is organic, unless the National Organic Program (section 6517 of the federal Organic Foods Production Act of 1990 (7 U.S.C. section 6501 et seq.)) authorizes organic designation and certification for cannabis and the cannabis or cannabis product meets the requirements for that designation and certification. This includes use of the word “organic” or variants in spelling such as “organix” on the labeling, except for use of the term “organic” in the ingredient statement on the informational panel of a cannabis product in compliance with the requirements of the programs established pursuant to Business and Professions Code section 26062.
(B) Any statement or indication that the cannabis or cannabis product is “OCal,” “OCal certified,” or made with “OCal cannabis,” if the cannabis or cannabis product has not been cultivated, handled, processed, or manufactured in compliance with the requirements of the programs established pursuant to Business and Professions Code Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 197 of 216 section 26062.
(6) Any statement or indication of an appellation of origin if the cannabis or cannabis product does not meet the requirements of the program established pursuant to Business and Professions Code section 26063.
Authority: Sections 26013 and 26130, Business and Professions Code. Reference:
Sections 26062.5, 26063, 26120, 26121 and 26154, Business and Professions Code. §17409. Statement of Characteristic Anticipated Effects. (a) A cannabis good may include information on the characteristic anticipated effects of the cannabis good if the licensee has substantiation that the information is truthful and not misleading. Such information may be located on the informational panel of the label or the supplemental labeling with the package. For purposes of this section, “characteristic anticipated effect” includes any physiological effect (a temporary effect on the body related to the consumption of cannabis goods) that is common to or expected from the particular cannabis strain, but excludes any claim of health benefits (i.e. claims of therapeutic action as a result of the consumption of cannabis goods).
Authority: Sections 26013 and 26130, Business and Professions Code. Reference:
Sections 26120 and 26130, Business and Professions Code. §17410. Universal Symbol.
(a) The symbol established pursuant to Business and Professions Code section 26130 shall replicate the following in form:
(b) The symbol shall be black in color. For packaging that is dark in color, the symbol shall be made conspicuous by printing the symbol on, or outlining the symbol with, a contrasting color.
(c) The symbol shall be no smaller in height than one-half (0.5) inch except as allowed under subsection (d).
(d) For a cannabis vape cartridge or integrated cannabis vaporizer, the symbol shall be engraved, printed, or affixed with a sticker in a size no smaller than one-quarter (0.25) inch wide by one-quarter (0.25) inch high.
(e) The symbol shall not be altered or cropped in any way other than to adjust the sizing for placement on the primary panel.
Authority: Sections 26013 and 26130, Business and Professions Code. Reference:
Sections 26120, 26121 and 26130, Business and Professions Code.
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 198 of 216 Article 4. Packaging
§17411. Packaging.
(a) A package used to contain a cannabis good shall comply with the following requirements:
(1) The package shall protect the cannabis good from contamination and shall not expose the good to any toxic or harmful substance.
(2) The package shall be tamper-evident, which means that the packaging is sealed so that the contents cannot be accessed without obvious destruction of the seal upon initial opening.
(3) If the cannabis good has more than one serving, the package shall be resealable. (4) The package shall not imitate any package used for products typically marketed to children.
(5) If the cannabis good is an edible product, the package shall be opaque. Colored bottles that obscure the color of the liquid inside shall be considered opaque for purposes of this section.
(6) Notwithstanding subsection (e), opaque bottles used to contain a cannabis beverage product may utilize a single, vertical, clear strip no wider than one-quarter (0.25) inch for the purpose of determining serving amounts.
(7) The package shall be child-resistant, as described in section 17412.
Authority: Sections 26013 and 26130, Business and Professions Code. Reference:
Sections 26120 and 26121, Business and Professions Code. §17412. Child-Resistant Packaging Requirements.
(a) A package containing cannabis or cannabis products transferred to a distributor for retail sale shall be child-resistant, as follows:
(1) The package for an edible product, an orally consumed concentrate, or a suppository shall be child-resistant for the life of the product. A package that contains more than a single serving is not required to be child-resistant if each individual serving is packaged in child-resistant packaging.
(2) Cannabis or a cannabis product intended to be inhaled or a cannabis product that is applied topically may utilize packaging that is child-resistant only until first opened, if the package is labeled with the statement: “This package is not child-resistant after opening.” (b) The following packages are considered child-resistant for purposes of this article:
(1) Any package that has been certified as child-resistant under the requirements of the Poison Prevention Packaging Act of 1970 Regulations (16 C.F.R. §1700.15(b)(1)) (Rev.
July 1995), which is hereby incorporated by reference.
(2) A bottle sealed with a pry-off, metal crown, cork-style bottle cap, provided that the bottle contains only a single serving.
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 199 of 216 (3) Plastic packaging that is at least four (4) mils thick and heat-sealed without an easyopen tab, dimple, corner, or flap, provided that the package contains a cannabis product described in subsection (a)(2) or a cannabis product that is only a single serving.
Authority: Sections 26013 and 26130, Business and Professions Code. Reference:
Sections 26011.5, 26120 and 26121, Business and Professions Code.
Chapter 12. Enforcement
Article 1. Authority
§17800. Right of Access.
(a) The Department and its authorized representatives, for purposes of inspection, investigation, review, or audit, shall have full and immediate access to:
(1) Enter any premises licensed by the Department.
(2) Inspect and 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 Department 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) Prior notice of an inspection, investigation, review, or audit is not required. (d) 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 Department and the licensee or its agents, employees, or representatives.
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 200 of 216 (e) If the licensed premises is not accessible because access is only available by going through another licensed premises and the licensee occupying the other licensed premises denies the Department access, the licensees shall both be held responsible and subject to discipline.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26013, 26015 and 26160, Business and Professions Code; and Section 11181, Government Code.
Article 2. Compliance and Enforcement Actions
§17801. Notice to Comply.
(a) The Department may issue a Notice to Comply to a licensee for violation(s) of the Act or this division discovered during an investigation or observed during an inspection. (b) The Notice to Comply shall be in writing and describe the nature and facts of each violation, including a reference to the statute or regulation violated, and may indicate the manner in which the licensee must correct the violation(s) to achieve compliance. (c) The Department may serve the Notice to Comply personally or by mail to the licensee, employee, agent, or person delegated by the licensee to accept notice. (d) The licensee shall sign and return the Notice to Comply and, if required, a written plan to address the violations or describe how compliance was achieved within 30 calendar days after the date of personal service or mailing of the notice, or a different date specified by the Department. The Department may also require the licensee to provide a plan for review and approval by the Department on a case-by-case basis. (e) Failure to correct the violation(s) in the Notice to Comply may result in disciplinary action.
Authority: Section 26013, Business and Professions Code; Reference: Sections 26012 and 26018, Business and Professions Code.
§17801.1 Notice of Violation.
(a) Until October 1, 2021, the Department may issue a Notice of Violation to a licensee for violation(s) of the Act of this division that shall inform the licensee of:
(1) The violation(s) alleged;
(2) The proposed fine amount; and
(3) The licensee’s right to request a hearing pursuant to subsection (b). (b) Within 30 calendar days after issuance by the Department, a licensee may appeal a Notice of Violation by submitting a written request for an informal hearing by mail to the Department of Cannabis Control, Legal Affairs Division, 2920 Kilgore Road, Rancho Cordova, CA 95670, or by email to [email protected]. The request shall include the following:
(1) The licensee’s name, mailing address, and daytime phone number; Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 201 of 216 (2) The license number issued by the Department;
(3) A copy of the Notice of Violation; and
(4) A clear and concise statement of the basis of the appeal. (c) If the licensee fails to submit a timely request for hearing pursuant to subsection (b), the Notice of Violation is not appealable and the Department may proceed upon the noticed violation(s) without a hearing.
(d) A hearing requested to appeal a Notice of Violation will be scheduled and conducted in accordance with chapter 5 (commencing with section 11500) of part 1 of division 3 of the Government Code.
(e) For all written requests for a hearing submitted by licensees and received by the Department prior to October 1, 2021, with hearings scheduled to take place on or after October 1, 2021, the following will occur:
(1) Informal hearing proceedings noticed prior to October 1, 2021, shall be converted to adjudicative proceedings under chapter 5 (commencing with section 11500) of part 1 of division 3 of the Government Code.
(2) Any scheduled informal hearings will be vacated, and a new hearing date, location and time will be noticed by the Department.
Authority cited: Section 26013, Business and Professions Code. Reference: Sections 26012, 26031 and 26031.5, Business and Professions Code. §17801.5. Embargo of Cannabis or Cannabis Products.
(a) The Department may embargo cannabis or cannabis products to prevent their sale, disposal, or removal from the location when the Department has probable cause to believe the cannabis or cannabis products are adulterated or misbranded or the sale would otherwise be in violation of the Act or this division. (b) To embargo cannabis or cannabis products, the Department shall:
(1) Provide initial notice to the licensee or product owner that the cannabis or cannabis products are subject to embargo and the reason for the embargo. Initial notice may be oral or written and may be provided in person or by telephone, mail, facsimile transmission, email, or other electronic means;
(2) Affix a tag or marking to the cannabis or cannabis products, or component thereof, subject to embargo; and
(3) Provide an inventory of the embargoed items to the licensee or product owner. (c) The Department shall further provide written notice to the licensee or product owner of the embargoed items that includes the following:
(1) The factual and legal bases for the embargo;
(2) A description of the cannabis or cannabis products under embargo; (3) A request for a written plan to address the issues(s) that resulted in the embargo; Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 202 of 216 (4) A summary of the proceedings for condemnation in accordance with chapter 5 (commencing with section 11500) of part 1 of division 3 of title 2 of the Government Code;
(5) Notification that the embargoed items cannot be removed, sold, or disposed of without authorization of the Department or a court; and (6) The penalty for violation of the embargo.
(d) The licensee or product owner may submit a written plan to the Department that describes how the licensee or product owner will address the issue(s) that resulted in the embargo.
(1) If the Department determines that the plan will resolve the issue(s) that resulted in the embargo, and that all of the provisions of the Act and this division can be complied with, the Department will approve the plan and supervise the completion of the plan. (2) If the Department cannot approve the plan, or the Department does not receive a response from the licensee within seven (7) calendar days after providing the notice described in subsection (c), the Department may initiate condemnation proceedings in accordance with Business and Professions Code section 26039.3(f). (e) A licensee or product owner or their authorized representative may provide written consent for the voluntary condemnation and destruction of the cannabis and cannabis products under embargo. Destruction and disposal of embargoed items shall be at the licensee or product owner’s expense and shall be conducted under the supervision of the Department.
(f) A licensee or product owner shall not remove the tag or marking from cannabis or cannabis products subject to embargo.
(g) A licensee or product owner shall not remove, sell, or dispose of any cannabis or cannabis products under embargo without written permission of the Department or a court. Each item removed, sold, or disposed of without written permission of the Department or a court constitutes a separate violation of the Act. (h) A licensed cultivator or a microbusiness authorized to engage in cultivation may request permission to continue cultivation or harvesting of cannabis under embargo. The request shall be made to the Department in writing at [email protected] and shall specify the cultivation or harvesting activities in which the licensee requests to engage. The Department may, in its sole discretion, authorize and impose conditions on the continued cultivation or harvesting of the cannabis under embargo.
Authority: Section 26013, Business and Professions Code. Reference: Section 26039.3, Business and Professions Code.
§17802. Citations; Orders of Abatement; Administrative Fines. (a) The Department may issue citations containing orders of abatement and fines against a licensee, or an unlicensed person, for any acts or omissions that are in violation of any provision of the Act or this division, or any another California laws applicable to cannabis licensees including, but not limited to, state labor law.
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 203 of 216 (b) The Department 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 may contain either order(s) of abatement, monetary fine(s), or both, and shall:
(1) Be in writing and describe with particularity the nature of the violation, including a reference to the statute or regulation determined to have been violated; (2) Fix a reasonable time for abatement of the violation if the citation contains an order of abatement;
(3) Assess an administrative fine of up to $5,000 per violation, per day, by a licensee and up to $30,000 per violation, per day, by an unlicensed person if the citation contains a fine;
(4) Be served personally or by certified mail; and
(5) Inform the licensee or person that they may request an informal conference, or contest the citation, or both, pursuant to section 17803 of this division. (d) Fines issued with a citation must be paid within 30 calendar days after service of the citation, unless the fine is contested. 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 payment of the renewal fee and fine. (e) The amount of any fine assessed by the Department under this section shall take into consideration the factors listed in Business and Professions Code section 26031.5(a)(1)- (3).
(f) Nothing in this section shall be deemed to prevent the Department from filing an accusation to suspend or revoke a license where grounds for such suspension or revocation exist.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26012, 26030 and 26031.5, Business and Professions Code.
§17803. Contesting Citations.
(a) A cited licensee or person may, within 30 calendar days after service of the citation, contest the citation by submitting to the Department a written request for a hearing, conducted in accordance with chapter 5 (commencing with section 11500) of part 1 of division 3 of the Government Code. If a hearing is not requested, it is waived and payment of a fine will not constitute an admission of the violation charged. (b) In addition to requesting a hearing provided for in subsection (a), the cited licensee or person may, within 15 calendar days after service of the citation, submit a written request for an informal conference with the Department regarding the acts or omissions charged in the citation.
(c) The Department shall, within 15 calendar days after receipt of the written request, hold an informal conference with the cited licensee or person and/or their legal counsel or authorized representative.
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 204 of 216 (d) At the conclusion of the informal conference, the Department may affirm, modify, or dismiss the citation, including any fines levied or orders of abatement issued. A written decision stating the reasons for the decision shall be mailed to the cited licensee or person and their legal counsel, if any, within 15 calendar days after the date of the informal conference. This decision shall be deemed to be a final order with regard to the citation issued, including the levied fine and the order of abatement, if any. (e) If the citation is dismissed, any request for a hearing shall be deemed withdrawn. If the citation is affirmed or modified, the cited licensee or person may either withdraw the request for a hearing or proceed with the administrative hearing process. (f) If the citation, including any fines levied or orders of abatement issued, is modified, the citation originally issued shall be considered withdrawn and new citation issued. If a hearing is requested for the subsequent citation, it shall be requested within 30 calendar days after issuance of the citation.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26012, 26016 and 26031.5, Business and Professions Code.
§17804. Citation Compliance.
(a) If a citation with an order of abatement is issued, the time to abate or correct a violation as provided for in the order of abatement may be extended for good cause. If a cited licensee or person who has been issued an order of abatement is unable to complete the correction within the time set forth in the citation because of conditions beyond their control after the exercise of reasonable diligence, the cited licensee or person may request an extension of time from the Department in which to complete the correction. The request must be in writing and made within the time set forth for abatement.
(b) When a citation is not contested, or if it is contested and the cited licensee or person does not prevail, failure to abate the violation within the time allowed or pay a fine that was imposed shall constitute a separate violation.
(c) Failure to timely comply with an order of abatement or pay a fine that was imposed may result in further action being taken by the Department, including, but not limited to, suspension or revocation of a license, or further administrative or civil proceedings.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26012 and 26031.5, Business and Professions Code.
§17805. Minor Decoys.
(a) Peace officers may use a person under 21 years of age to attempt to purchase cannabis goods, for the purposes of enforcing the Act and to apprehend licensees, employees, or agents of licensees who sell cannabis goods to minors. For purposes of this section, a “minor” is a person under 21 years of age. (b) The following minimum standards shall apply to the use of a minor decoy:
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 205 of 216 (1) At the time of the operation, the decoy shall be less than 20 years of age. (2) A decoy shall either carry identification showing the decoy’s correct date of birth or carry no identification. A decoy who carries identification shall present it upon request to any seller of cannabis goods.
(3) A decoy shall truthfully answer any questions about their age. (4) Following any completed sale, but not later than the time a citation, if any, is issued, the peace officer directing the decoy shall make a reasonable attempt to enter the licensed premises or respond to the location where the licensee is located and have the minor decoy who purchased cannabis goods identify the alleged seller of the cannabis goods.
Authority: Sections 26013 and 26140, Business and Professions Code. Reference:
Section 26140, Business and Professions Code.
§17806. Attire and Conduct.
(a) No licensee shall allow the following:
(b) Employment or use of any person in the sale or service of cannabis goods in or upon the licensed premises while such person is unclothed or in such attire, costume, or clothing as to expose to view any portion of the breast below the top of the areola or of any portion of the pubic hair, anus, cleft of the buttocks, vulva, or genitals. (c) Employment or use of the services of any host or other person to mingle with the patrons while such host or other person is unclothed or in such attire, costume, or clothing as described in subsection (a).
(d) Encouraging or permitting any person on the licensed premises to touch, caress, or fondle the breasts, buttocks, anus, or genitals of any other person. (e) Permitting any employee or person to wear or use any device or covering, exposed to view, which simulates the breast, genitals, anus, pubic hair, or any portion thereof.
Authority: Section 26013, Business and Professions Code. Reference: Section 26011.5, Business and Professions Code.
§17807. Entertainers and Conduct.
(a) Live entertainment is permitted on a licensed premises, except that no licensee shall permit any person to perform acts of or acts that simulate:
(1) Sexual intercourse, masturbation, sodomy, bestiality, oral copulation, flagellation, or any sexual acts that are prohibited by law.
(2) Touching, caressing, or fondling of the breast, buttocks, anus, or genitals. (3) Displaying of the buttocks, breasts, pubic hair, anus, vulva, or genitals. (b) No licensee shall permit any person to use artificial devices or inanimate objects to depict any of the prohibited activities described in this section.
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 206 of 216 (c) No licensee shall permit any person to remain in or upon the licensed premises who exposes to public view any portion of their breast, buttocks, genitals, or anus.
Authority: Section 26013, Business and Professions Code. Reference: Section 26011.5, Business and Professions Code.
Article 3. Disciplinary Actions
§17808. Additional Grounds for Discipline.
The following include, but are not limited to, additional grounds that constitute a basis for disciplinary action:
(a) Failure to pay a fine imposed by the Department or agreed to by the licensee. (b) Failure to take reasonable steps to correct objectionable conditions on the licensed premises, including the immediately adjacent area that is owned, leased, or rented by the licensee, that constitute a nuisance, within a reasonable time after receipt of notice to make those corrections, under Penal Code section 373a.
(c) Failure to take reasonable steps to correct objectionable conditions that occur during operating hours on any public sidewalk abutting a licensed premises and constitute a nuisance, within a reasonable time after receipt of notice to correct those conditions from the Department. This subsection shall apply to a licensee only upon written notice to the licensee from the Department. The Department shall issue this written notice upon its own determination, or upon a request from the local law enforcement agency in whose jurisdiction the licensed premises is located, that is supported by substantial evidence that persistent objectionable conditions are occurring on the public sidewalk abutting the licensed premises. For purposes of this subsection:
(1) “Any public sidewalk abutting a licensed premises” means the publicly owned, pedestrian-traveled way, not more than 20 feet from the licensed premises, that is located between a licensed premises, including any immediately adjacent area that is owned, leased, or rented by the licensee, and a public street. (2) “Objectionable conditions that constitute a nuisance” means disturbance of the peace, public intoxication, drinking alcoholic beverages in public, smoking or ingesting cannabis or cannabis products in public, harassment of passersby, gambling, prostitution, loitering, public urination, lewd conduct, drug trafficking, or excessive loud noise. (3) “Reasonable steps” means all of the following:
(A) Calling the local law enforcement agency. Timely calls to the local law enforcement agency that are placed by the licensee or their agents or employees shall not be construed by the Department as evidence of objectionable conditions that constitute a nuisance.
(B) Requesting that those persons engaging in activities causing objectionable conditions to cease those activities, unless the licensee or their agents or employees feel that their personal safety would be threatened in making that request. (C) Making good faith efforts to remove items that facilitate loitering, such as furniture, Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 207 of 216 except those structures approved or permitted by the local jurisdiction. The licensee shall not be liable for the removal of those items that facilitate loitering. (4) When determining what constitutes “reasonable steps,” the Department shall consider site configuration constraints related to the unique circumstances of the nature of the business.
(5) Even after correcting the objectionable conditions that constitute a nuisance, the licensee has a continuing obligation to meet the requirements of subsections (b) and (c), and failure to do so shall constitute grounds for disciplinary action. (d) Knowingly permitting the illegal sale, or negotiations for the illegal sale, of controlled substances or dangerous drugs upon the licensed premises. Successive sales, or negotiations for sales, over any continuous period of time shall be deemed evidence of permission. As used in this section, “controlled substances” has the same meaning as in Health and Safety Code section 11007, and “dangerous drugs” has the same meaning as in Business and Professions Code section 4022.
(e) If the licensee has employed or permitted any person to solicit or encourage others, directly or indirectly, to buy that person’s cannabis goods in the licensed premises under any commission, percentage, salary, or other profit-sharing plan, scheme, or conspiracy.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26011.5, 26012, 26030 and 26031, Business and Professions Code.
§17809. Disciplinary Actions.
(a) When an accusation recommending disciplinary action against a licensee has been filed pursuant to Business and Professions Code section 26031, the accusation shall be served on the licensee in accordance with Government Code section 11505. (b) A hearing shall be conducted in accordance with the provisions of chapter 5 (commencing with section 11500) of part 1 of division 3 of title 2 of the Government Code to determine if cause exists to take action against the licensee. At the hearing, the Department shall have all of the powers granted by the statutes cited above and by the Business and Professions Code.
(c) If a hearing on an accusation against a licensee results in a finding that the licensee has committed any of the acts or omissions constituting grounds for disciplinary action, the Department may order the license revoked, suspended outright for a specified period of time, or suspended on probationary restriction for a specified period of time, including terms and conditions of probation the Department considers appropriate on the basis of its findings, impose a fine, or any combination thereof. The Department may also issue other lawful orders it considers appropriate on the basis of its findings.
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 208 of 216 (d) An accusation may be terminated by written stipulation at any time prior to the conclusion of the hearing on the accusation. If a licensee submits a proposed stipulation to the Department for its consideration and the Department subsequently declines to accept the proposed stipulation, the Department shall not thereafter be disqualified from hearing evidence on the accusation and taking action thereon as authorized in this section.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26012, 26031 and 26034, Business and Professions Code.
§17810. Interim Suspension.
(a) Pursuant to Business and Professions Code section 494, the Department may petition for an interim order to suspend any license or impose licensing restrictions upon any licensee if:
(1) The licensee has engaged in acts or omissions constituting a violation of the Business and Professions Code or this division, or been convicted of a crime substantially related to the licensed activity, and
(2) Permitting the licensee to continue to engage in the licensed activity would endanger the public health, safety, or welfare.
(b) An interim order for suspension or restrictions may be issued with notice, as follows:
(1) The Department shall provide the licensee with at least 15 days’ notice of the hearing on the petition for an interim order.
(2) The notice shall include all documents submitted in support of the petition. (c) An interim order for suspension or restrictions may be issued without notice to the licensee if it appears from the Department’s petition and supporting documents that serious injury would result to the public before the matter could be heard on notice. (2) The licensee shall be entitled to a hearing on the petition within 20 days after issuance of the initial interim order.
(3) Notice of the hearing shall be provided to the licensee by the Department within two days after issuance of the initial interim order.
(4) The licensee shall receive all documents in support of the petition. (d) The Department shall file an accusation, pursuant to chapter 5 (commencing with section 11500) of part 1 of division 3 of title 2 of the Government Code, within 15 calendar days after issuance of the interim order.
Authority: Section 26013, Business and Professions Code; Reference: Sections 494, 26011.5, 26012 and 26031, Business and Professions Code. §17813. Enforcement Costs.
(a) In any order in resolution of a disciplinary proceeding for suspension or revocation of a license, the Department may request the administrative law judge to direct a licensee Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 209 of 216 found to have committed a violation or violations of the Act or this division to pay a sum not to exceed the reasonable costs of the investigation and enforcement of the case. (b) A certified copy of the actual costs, or a good faith estimate of costs where actual costs are not available, signed by the Department’s designated representative shall be prima facie evidence of reasonable costs of investigation and prosecution of the case.
The costs shall include the amount of investigative and enforcement costs up to the date of the hearing, including, but not limited to, charges imposed by the Attorney General. (c) The administrative law judge shall make a proposed finding of the amount of reasonable costs of investigation and prosecution of the case when requested pursuant to subsection (a). The Department may reduce or eliminate the cost award, or remand to the administrative law judge where the proposed decision fails to make a finding on costs requested pursuant to subsection (a).
(d) Where an order for recovery of costs is made and timely payment is not made as directed in the decision, the Department may enforce the order for repayment in any appropriate court. This right of enforcement shall be in addition to any other rights the Department may have to recover costs.
(e) In any action for recovery of costs, proof of the decision shall be conclusive proof of the validity of the order of payment and the terms for payment. (f) Except as provided in subsection (g), the Department shall not renew or reinstate any license of a licensee who has failed to pay all of the costs ordered under this division. (g) Notwithstanding subsection (f), the Department may, in its discretion, conditionally renew or reinstate for a maximum of one year the license of any licensee who demonstrates financial hardship and enters into a formal agreement with the Department for reimbursement within that one-year period for the unpaid costs. (h) Nothing in this section shall preclude the Department from including recovery of the costs of investigation and enforcement of a case in any stipulated settlement.
Authority: Section 26013, Business and Professions Code; Reference: Sections 125.3, 26012 and 26031, Business and Professions Code.
§17814. Disciplinary Guidelines.
In reaching a decision on a disciplinary action under the Act and the Administrative Procedure Act (Govt. Code section 11400 et seq.), the Department shall consider the disciplinary guidelines entitled “Department of Cannabis Control Disciplinary Guidelines for All Commercial Cannabis Licenses Amended September 2021,” which are hereby incorporated by reference. Deviation from these guidelines and orders, including the standard terms of probation, is appropriate where the Department in its sole discretion determines that the facts of the particular case warrant such a deviation (e.g., the presence of mitigating factors, the age of the case, or evidentiary problems).
Authority: Section 26013, Business and Professions Code; Reference: Sections 26012 and 26031, Business and Professions Code.
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 210 of 216 Article 4. Emergency Decision and Orders
§17815. Emergency Decision and Order.
(a) The Department may issue an emergency decision and order for temporary, interim relief to prevent or avoid immediate danger to the public health, safety, or welfare. Such circumstances include, but are not limited to, the following:
(1) The Department has information that cannabis goods at a licensee’s premises have a reasonable probability of causing serious adverse health consequences or death. (2) To prevent the sale, transfer, or transport of contaminated or illegal cannabis goods in possession of a licensee.
(3) The Department observes or has information that conditions at a licensee’s premises exist that present an immediate risk to worker or public health and safety. (4) To prevent illegal diversion of cannabis goods, or other criminal activity at a licensee’s premises.
(5) To prevent the destruction of evidence related to illegal activity or violations of the Act.
(6) To prevent misrepresentation to the public, such as selling untested cannabis goods, providing inaccurate information about the cannabis goods or cannabis goods that have been obtained from an unlicensed person.
(b) Temporary, interim relief may include a suspension or administrative hold by one or more of the following:
(1) An order temporarily suspending a license.
(2) An order to segregate or isolate specific cannabis goods. (3) An order prohibiting the movement of cannabis goods to or from the premises. (4) An order prohibiting the sale of specific cannabis goods. (5) An order prohibiting the destruction of specific cannabis goods. (c) The emergency decision and order issued by the Department shall include a brief explanation of the factual and legal bases of the emergency decision that justify the Department’s determination that emergency action is necessary, and the specific actions ordered. The emergency decision and order shall be effective when issued or as otherwise provided by the decision and order.
(d) To issue an administrative hold that prohibits activity related to specified cannabis goods, the Department shall comply with the following:
(1) Provide notice of the administrative hold that includes a description of the cannabis goods subject to the administrative hold.
(2) Following notice, the Department shall identify the cannabis goods subject to the administrative hold in the track and trace system.
(e) A licensee subject to an administrative hold shall comply with the following:
(1) Within 24 hours after receipt of notice of the administrative hold, physically segregate Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 211 of 216 all designated cannabis goods in a limited-access area of the licensed premises. The licensee shall ensure that all cannabis goods subject to the administrative hold are safeguarded and preserved in a manner that prevents tampering, degradation, or contamination.
(2) While the administrative hold is in effect, the licensee shall not sell, donate, transfer, transport, gift, or destroy the cannabis goods subject to the hold. (3) A microbusiness licensee subject to an administrative hold may continue to cultivate any cannabis subject to an administrative hold. If the cannabis subject to the hold must be harvested, the licensee shall place the harvested cannabis into separate batches. (4) A licensee may voluntarily surrender cannabis goods that are subject to an administrative hold. The licensee shall identify the cannabis goods being voluntarily surrendered in the track and trace system. Voluntary surrender shall not be construed to waive the right to a hearing or any associated rights.
(f) To issue a temporary suspension, the Department shall specify in the order that the licensee shall immediately cease conducting all commercial cannabis activities under its license, unless otherwise specified in the order.
(g) A microbusiness licensee subject to a temporary suspension may continue to cultivate cannabis at the licensed premises only as prescribed by the Department in the order. If the order permits the cannabis to be harvested, the licensee shall place the harvested cannabis into separate batches.
(h) The emergency decision and order for temporary, interim relief shall be issued in accordance with the following procedures:
(1) The Department shall give notice of the emergency decision and order and an opportunity to be heard to the licensee prior to the issuance, or effective date, of the emergency decision and order, if practicable.
(2) Notice and hearing under this section may be oral or written and may be provided by telephone, personal service, mail, facsimile transmission, electronic mail, or other electronic means, as the circumstances permit.
(3) Notice may be given to the licensee, any person meeting the definition of owner for the license, or to a manager or other personnel at the licensed premises. (4) Upon receipt of the notice, the licensee may request a hearing within three (3) business days by submitting a written request for hearing to the Department through electronic mail, facsimile transmission, or other means. The hearing shall commence within five (5) business days after receipt of the written request for hearing, unless a later time is agreed upon by the Department and the licensee. (5) The hearing may be conducted in the same manner as an informal conference under section 17803; however, the timeframes provided in section 17803 shall not apply to a hearing under this section. Pre-hearing discovery or cross-examination of witnesses is not required under this section.
(6) The emergency decision and order shall be affirmed, modified, or set aside as determined appropriate by the Department within five (5) business days after the hearing.
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 212 of 216 (i) Within ten (10) calendar days after the issuance or effective date of the emergency decision and order for temporary, interim relief, the Department shall commence adjudicative proceedings in accordance with chapter 5 (commencing with section 11500) of part 1 of division 3 of title 2 of the Government Code to resolve the underlying issues giving rise to the temporary, interim relief.
(j) After formal proceedings are held pursuant to subsection (i), a licensee aggrieved by a final decision of the Department may appeal the decision to the Cannabis Control Appeals Panel pursuant to section 26043 of the Act.
(k) Notwithstanding administrative proceedings commenced pursuant to subsection (i), the licensee may obtain judicial review of the emergency decision and order pursuant to section 1094.5 of the Code of Civil Procedure in the manner provided in section 11460.80 of the Government Code without exhaustion of administrative remedies. (l) The Department’s authority provided by this section may be used in addition to any civil, criminal, or other administrative remedies available to the Department.
Authority: Section 26013, Business and Professions Code. Reference: Section 26012, Business and Professions Code; and Sections 11460.10, 11460.20, 11460.30, 11460.40, 11460.50, 11460.60, 11460.70 and 11460.80, Government Code.
Article 5. Posting Notices of Suspension and Revocation §17816. Posting of Notice of Suspension.
(a) A licensee whose license has been suspended shall conspicuously and continuously display a notice on the exterior of the licensee’s premises for the duration of the suspension.
(b) The notice shall be 11 inches in length and 8.5 inches in width. The notice shall read:
NOTICE OF SUSPENSION
The Department of Cannabis Control License(s) Issued For This Premises Has Been Suspended For Violation of State Law
(c) Advertising or posting signs to the effect that the licensed premises has been closed or that business has been suspended for any reason other than the reason provided in the decision suspending the license, shall be deemed a violation of this section. (d) Failure to display the notice as required in this section or removal of the notice prior to the expiration of the suspension shall be a violation of this section and may result in additional disciplinary action.
(e) A licensee shall notify the Department by submitting the Licensee Notification and Request Form, Notifications and Requests Regarding Regulatory Compliance, DCC-LIC028 (New 9/21), incorporated herein by reference, within 24 hours of discovering that the notice under subsection (b) of this section has been removed or damaged to an extent that makes the notice illegible.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26011.5 and 26012, Business and Professions Code.
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 213 of 216 §17817. Posting of Notice of Revocation.
(a) A person whose license has been revoked shall conspicuously display a notice on the exterior of the premises indicating that the license has been revoked. The notice shall remain continuously on the premises for at least 15 calendar days. (b) The notice shall be 11 inches in length and 8.5 inches in width. The notice shall read:
NOTICE OF REVOCATION
The Department of Cannabis Control License(s) Issued For This Premises Has Been Revoked For Violation of State Law
(c) Advertising or posting signs to the effect that the premises has been closed, or that business has been suspended for any reason other than the reason provided in the decision revoking the license, shall be deemed a violation of this section. (d) If the Department revokes a license at a licensed premises that has one or more licenses at the location that will remain active after the revocation, the revocation notice shall remain posted for a period of at least 15 calendar days. (e) Failure to display the notice for the time required in this section shall be a violation of this section and may result in additional disciplinary action. (f) A person whose license has been revoked shall notify the Department by submitting the Licensee Notification and Request Form, Notifications and Requests Regarding Regulatory Compliance, DCC-LIC-028 (New 9/21), incorporated herein by reference, within 24 hours of discovering that the notice under subsection (b) has been removed or damaged to an extent that makes the notice illegible.
Authority: Section 26013, Business and Professions Code. Reference: Sections 26011.5 and 26012, Business and Professions Code.
Chapter 13. Other Provisions
Article 1. Research Funding
§17900. Eligibility.
(a) Only public universities in California shall be eligible to be selected to receive funds disbursed pursuant to Revenue and Taxation Code section 34019(b). (b) Subject to available funding, the amounts to be disbursed to the university or universities will not exceed the sum of ten million dollars ($10,000,000) for each fiscal year, ending with the 2028-2029 fiscal year.
Authority: Section 26013, Business and Professions Code. Reference: Section 34019, Revenue and Taxation Code.
§17901. Request for Proposals.
(a) A Request for Proposal (RFP) is the document issued by the Department to notify all eligible fund recipients of the following, at a minimum:
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 214 of 216 (1) The funding available for research related to the Act or this division; (2) Disbursement of funds to eligible applicants through a review and selection process, including the criteria that will be used for review and selection; (3) The specified timeframes for the proposal review and selection process, including the deadline for submission of proposals;
(4) Proposal requirements, including necessary documentation; (5) Any priorities or restrictions imposed upon the use of the funds; (6) The governing statutes and regulations; and
(7) The name, address, and telephone number of a contact person within the Department who can provide further information regarding the process for submission of proposals.
Authority: Section 26013, Business and Professions Code. Reference: Section 34019, Revenue and Taxation Code.
§17902. Selection Process and Criteria.
(a) The selection process shall involve eligible proposals timely received by the Department, in response to an applicable RFP, or similar notice. (b) The Department will consider only one proposal per applicant for a given research project. Applicants may submit more than one proposal if the proposals are for separate and distinct research projects or activities.
(c) The Department will make a selection for funding based on criteria including, but not limited to:
(1) The extent to which the proposed project is designed to achieve objectives specified in Revenue and Taxation Code section 34019(b).
(2) The extent to which the proposed project is designed to achieve measurable outcomes, and the clarity of the measures for success, including, for research-based objectives, the scientific and technical merit of the proposed project as evaluated by relevant experts.
(3) The extent to which the proposed project is feasible, demonstrated by:
(A) A timeline for project completion, including readiness; and (B) Budget detail.
(4) Qualifications of the staff who will be assigned to or working on the proposed project. (5) Any other criteria to determine the proposed project’s efficacy in evaluating the implementation and effect of the Act.
(d) Applicants selected for funding will be notified of the selection and amount of funding in writing.
Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 215 of 216 (e) The Department’s selection decision is final and not subject to appeal.
Authority: Section 26013, Business and Professions Code. Reference: Section 34019, Revenue and Taxation Code.
§17903. Release of Funds.
(a) The Department shall not cause funds to be disbursed until the recipient has executed a Grant Agreement and any other required documents. (b) Selected recipients shall receive a single disbursement of funds for the duration of the research project.
(c) Funds released to the recipient that will be used for the purchase of any equipment related to the research project shall, at a minimum, meet the following conditions:
(1) Prior to the purchase of any equipment, the recipient shall obtain written approval from the Department.
(2) Receipts or other documentation for the purchase of any equipment shall be provided to the Department immediately upon purchase and request and retained pursuant to section 17904.
(d) Any funds that are not used prior to the completion of the research project shall be forfeited.
Authority: Section 26013, Business and Professions Code. Reference: Section 34019, Revenue and Taxation Code.
§17904. Reports to the Department.
(a) The recipient of funds shall provide regular performance reports to the Department in the following manner, unless otherwise specified in the Grant Agreement:
(1) At monthly intervals for research projects with an estimated completion time not exceeding one year.
(2) At quarterly intervals for research projects with an estimated completion time exceeding one year.
(b) Performance reports shall include, at a minimum:
(1) A detailed, estimated time schedule of completion for the research project; (2) A description of any measurable outcomes, results achieved, or other completed objectives of the research project;
(3) A description of remaining work to be completed;
(4) A summary of expenditures of the funds and statement of whether the research project is meeting the proposed budget. If not, the reasons for any discrepancies and a list of actions that will be taken to ensure completion of the research project; and Department of Cannabis Control
Medicinal and Adult Use Commercial Cannabis Regulations Page 216 of 216 (5) Any changes to the information provided in the proposal, including, but not limited to, change in staff.
Authority: Section 26013, Business and Professions Code. Reference: Section 34019, Revenue and Taxation Code.
§17905. Research Records.
Recipients shall retain all research and financial data necessary to substantiate the purposes for which the funds were spent for the duration of the funding, and for a period of seven years after completion of the research project. Recipients shall provide this documentation to the Department upon request.
Authority: Section 26013, Business and Professions Code. Reference: Section 26160, Business and Professions Code; and Section 34019, Revenue and Taxation Code.