SUBCHAPTER 3.

REQUIREMENTS OF OPERATION

Table of Contents

Article 1. Safety and Security

§40200. Security Plan.

Every licensee shall develop and implement a written security plan. At a minimum, the security plan shall include a description of the security measures to:

§ 40200 (a) Prevent access to the manufacturing premises by unauthorized persons and protect the physical safety of employees. This includes, but is not limited to:

(1) Establishing physical barriers to secure perimeter access and all points of entry into a manufacturing premises (such as locking primary entrances with commercial grade, non-residential door locks, or providing fencing around the grounds and driveway, and securing any secondary entrances including windows, roofs, or ventilation systems);

(2) Installing a security alarm system to notify and record incident(s) where physical barriers have been breached;

(3) Establishing an identification and sign-in/sign-out procedure for authorized personnel, suppliers, and visitors;

(4) Maintaining the premises such that visibility and security monitoring of the premises is possible; and

(5) Establishing procedures for the investigation of suspicious activities.

§ 40200 (b) Prevent against theft or loss of cannabis and cannabis products. This includes but is not limited to:

(1) Establishing an inventory system to track cannabis and cannabis products and the personnel responsible for processing it throughout the manufacturing process;

(2) Limiting access of personnel within the premises to those areas necessary to complete job duties, and to those time-frames specifically scheduled for completion of job duties, including access by outside vendors, suppliers, contractors or other individuals conducting business with the licensee that requires access to the premises;

(3) Supervising tasks or processes with high potential for diversion, including the loading and unloading of cannabis transportation vehicles; and

(4) Providing areas in which personnel may store and access personal items that are separate from the manufacturing areas.

§ 40200 (c) Secure and back up electronic records in a manner that prevents unauthorized
access and that ensures the integrity of the records is maintained.

Authority: Sections 26012, 26013 and 26130, Business and Professions Code.
Reference: Sections 26011.5 and 26051.5, Business and Professions Code.

§40205. Video Surveillance.

§ 40205 (a) At minimum, a licensed premises shall have a digital video surveillance system with a minimum camera resolution of 1280 × 720 pixels. The video surveillance system shall be able to effectively and clearly record images of the area under surveillance.

§ 40205 (b) To the extent reasonably possible, all video surveillance cameras shall be installed in a manner that prevents intentional obstruction, tampering with, or disabling.

§ 40205 (c) Areas that shall be recorded on the video surveillance system include the following:

(1) Areas where cannabis or cannabis products are weighed, packed, stored, quarantined, loaded and unloaded for transportation, prepared, or moved within the premises;

(2) Limited-access areas;

(3) Security rooms;

(4) Areas containing surveillance-system storage devices, which shall contain at least one camera to record the access points to such an area; and

(5) The interior and exterior of all entrances and exits to the premises.

§ 40205 (d) The surveillance system shall record continuously 24 hours per day and at a minimum speed of 15 frames per second.

§ 40205 (e) Any on-site surveillance system storage devices shall be located in secure rooms or areas of the premises in an access-controlled environment.

§ 40205 (f) The licensee shall ensure that all surveillance recordings are kept for a minimum of 90 days.

§ 40205 (g) All video surveillance recordings shall be available on the licensed premises and are subject to inspection by the Department and shall also be copied and sent, or otherwise provided, to the Department upon request.

§ 40205 (h) The video recordings shall display the current date and time of recorded events. Time is to be measured in accordance with the U.S. National Institute of Standards and Technology standards. The displayed date and time shall not significantly obstruct the view of recorded images.

§ 40205 (i) If multiple licensed premises are contained within the same building, a single video surveillance system covering the entire building may be used by all of the licensees under the following conditions:

(1) Each applicant or licensee shall disclose on their premises diagram where the surveillance recordings are stored;

(2) Each applicant or licensee shall include in their security operating procedures an explanation of how the video surveillance system will be shared, including who is responsible for monitoring the video footage and storing any video recordings;

(3) All licensees shall have immediate access to the surveillance recordings to produce them pursuant to the requirements of this section;

(4) All licensees shall be held responsible and subject to discipline for any violations of the video surveillance requirements.

Authority: Sections 26012, 26013 and 26130, Business and Professions Code.
Reference: Sections 26011.5 and 26070, Business and Professions Code

§40207. Notification of Theft, Loss, or Diversion.

If a licensee finds evidence of theft or diversion of cannabis or cannabis products, the licensee shall report the theft or diversion to the Department and local law enforcement within 24 hours of the discovery. The notice to the Department shall be in writing and shall include the date and time of the incident; a description of the incident, including items that were taken or missing; and the name of the local law enforcement agency that was notified of the incident.

Authority: Sections 26012, 26013 and 26130, Business and Professions Code.
Reference: Sections 26011.5 and 26070, Business and Professions Code.

Article 2. Extractions

§40220. Permissible Extractions.

§ 40220 (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 such as a nonhydrocarbon-based or other solvent such as water, vegetable glycerin, vegetable oils, animal fats, or glycerin. Nonhydrocarbon-based solvents shall be food grade;

(3) Chemical extraction using a professional closed loop CO2 gas extraction system. CO2 gas used for extraction shall be food grade;

(4) Chemical extraction using a volatile solvent, as defined in Section 40100(xx), using a professional closed loop extraction system; or

(5) Any other method authorized by the Department pursuant to subsection (b).

§ 40220 (b) To request authorization from the Department to conduct cannabis extraction using a method other than those specified in paragraphs (1) through (4) of subsection (a), 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 26012, 26013 and 26130, Business and Professions Code.
Reference: Sections 26011.5 and 26130, Business and Professions Code.

§40222. Volatile Solvent Extractions.

Chemical extractions using volatile solvents shall be subject to the following requirements:

§ 40222 ​(a) Hydrocarbon-based solvents shall be at least 99 percent purity;

§ 40222 (b) All extractions shall be performed in a closed loop extraction system as described in Section 40225; and

§ 40222 (c) No volatile solvent extraction operations shall occur in an area zoned as residential.

Authority: Sections 26012, 26013 and 26130, Business and Professions Code.
Reference: Sections 26011.5, 26105 and 26130, Business and Professions Code.

§40223. Ethanol Extractions.

§ 40223 (a) Ethanol used for extractions or for post-extraction processing shall be foodgrade.

§ 40223 (b) Ethanol extraction operations shall be approved by the local fire code official and shall be operated in accordance with applicable Division of Occupational Safety and Health (Cal/OSHA) regulations and any other state and local requirements.

Authority: Sections 26012, 26013 and 26130, Business and Professions Code.
Reference: Sections 26011.5 and 26130, Business and Professions Code.

§40225. Closed-Loop Extraction System Requirements.

§ 40225 (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 by a California-licensed engineer that the system was 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).

§ 40225 (b) Professional closed loop systems, other equipment used, the extraction operation, and facilities must be approved for use by the local fire code official and comply with any required fire, safety, and building code requirements related to the processing, handling, and storage of the applicable solvent or gas.

§ 40225 (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.

§ 40225 (d) The licensee shall establish and implement written procedures to document that the closed loop extraction system is maintained in accordance with the equipment manufacturer specifications and to ensure routine verification that the system is operating in accordance with specifications and continues to comply with fire, safety, and building code requirements.

§ 40225 (e) A licensee shall develop standard operating procedures, good manufacturing practices, and a training plan prior to producing extracts. Any personnel using solvents or gases in a closed loop system to create extracts must be trained on how to use the system, have direct access to applicable safety data sheets, and handle and store solvents and gases safely.

§ 40225 (f) The extraction operation shall be operated in an environment with proper ventilation, controlling all sources of ignition where a flammable atmosphere is or may be present, and shall be operated in accordance with applicable Division of Occupational Safety and Health (Cal/OSHA) regulations and any other state and local requirements.

§ 40225 (g) No closed loop extraction system operation shall occur in an area zoned as residential.

Authority: Sections 26012, 26013 and 26130, Business and Professions Code.
Reference: Sections 26011.5, 26105 and 26130, Business and Professions Code.

Article 3. Good Manufacturing Practices

§40230. Manufacturing Practices Definitions.

In addition to the definitions in section 26001 of the Act and Section 40100 of these regulations, the following definitions shall govern the construction of this article:

§ 40230 (a) “Allergen cross-contact” means the unintentional incorporation of a food allergen into a cannabis product.

§ 40230 (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 final form of the product. “Component” includes cannabis, cannabis products used as ingredients, raw materials, other ingredients, and processing aids.

§ 40230 (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.

§ 40230 (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.

§ 40230 (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 spore-forming bacteria.

§ 40230 (f) “Hazard” means any biological, chemical, radiological, or physical agent that has the potential to cause illness or injury.

§ 40230 (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.

§ 40230 (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.

§ 40230 (i) “Monitor” means to conduct a planned sequence of observations or measurements to assess whether preventive measures are operating as intended.

§ 40230 (j) “Pathogen” means a microorganism that can cause illness or injury.

§ 40230 (k) “Pest” means an undesired insect, rodent, nematode (small worm), fungus, bird, vertebrate, invertebrate, weed, virus, bacteria, or other microorganism (except microorganisms on or in humans or animals) injurious to health or the environment.

§ 40230 (l) “Potable” means water that meets the requirements of Health and Safety Code section 113869.

§ 40230 (m) “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 40253.

§ 40230 (n) “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.

§ 40230 (o) “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 licensee.

§ 40230 (p) “Quality control” means a planned and systematic operation or procedure for ensuring the quality of a cannabis product.

§ 40230 (q) “Quality control operation” means a planned and systematic procedure for taking all actions necessary to prevent cannabis product(s) from being adulterated or misbranded.

§ 40230 (r) “Quality control personnel” means any person, persons, or group, designated by the licensee to be responsible for quality control operations.

§ 40230 (s) “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.

§ 40230 (t) “Sanitize” means to treat cleaned surfaces by a process that is effective in destroying vegetative cells of pathogens, and in substantially reducing numbers of other undesirable microorganisms, but without adversely affecting the product or its safety for the consumer.

§ 40230 (u) “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.

§ 40230 (v) “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.

§ 40230 (w) “Validate” means obtaining and evaluating scientific and technical evidence that a control measure, combination of control measures, or quality control procedures as a whole, when properly implemented, is capable of ensuring the quality of a cannabis product or effectively controlling an identified hazard.

§ 40230 (x) “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.

§ 40230 (y) “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 26012, 26013 and 26130, Business and Professions Code.
Reference: Sections 26001 and 26130, Business and Professions Code.

§40235. Quality Control Program.

§ 40235 (a) Each licensee is responsible for implementing a quality control program to ensure that cannabis products are not adulterated or misbranded. The quality control program shall include quality control operations for all of the following:
(1) The grounds, building, and manufacturing premises, as specified in Section 40240;
(2) Equipment and utensils, as specified in Section 40243;
(3) Personnel, as specified in Section 40246;
(4) Cannabis product components, as specified in Section 40248; and
(5) Manufacturing processes and procedures, as specified in Section 40250.
§ 40235 (b) Quality control shall be under the supervision of one or more qualified individuals assigned responsibility for this function.
§ 40235 (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 26012, 26013 and 26130, Business and Professions Code.
Reference: Sections 26011.5 and 26131, Business and Professions Code.

§40240. Grounds, Building, and Manufacturing Premises.

§ 40240 (a) Exterior facility and grounds. The licensee shall ensure the facility exterior and grounds under the licensee’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) The licensee shall implement precautions within the premises such as inspection or extermination if the premises is bordered by grounds outside the licensee’s control that are not maintained in the manner described in paragraphs (1) through (5) of this subsection, 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.

§ 40240 (b) Interior facility. The licensee shall ensure construction, design, and maintenance of the interior of the manufacturing premises as follows:

(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 products, contact surfaces or packaging material.

(2) Lighting. Interior facility lighting shall meet the requirements of subdivisions (a)(1) and (3), (b)(3) and (4), and (c) of section 114252 of the Health and Safety Code. Interior facility lighting shall also meet the requirements for shatter-resistant lighting in section 114252.1 of the Health and Safety Code. The requirements of Health and Safety Code section 114252.1, subdivision (a), shall also apply to all areas where glass breakage may result in the contamination of exposed cannabis, components or cannabis products at any step of preparation.

(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 processing of cannabis products; in all areas used for the cleaning of equipment, utensils, and packaging materials; and for employee sanitary facilities. Any water that contacts cannabis, components, cannabis products, 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 to cannabis products, contact surfaces, or packaging materials.

(D) Toilet facilities. Each manufacturing premises 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. Each manufacturing premises shall provide handwashing facilities that meet the requirements of Health and Safety Code section 113953, subdivision (a) through (d).

(F) Waste disposal. The premises shall provide waste disposal in accordance with Health and Safety Code sections 114244(a), 114244(c), and 114245.1. Cannabis waste shall be disposed of in accordance with Section 40290 of these regulations.

(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).

(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 26012, 26013 and 26130, Business and Professions Code.
Reference: Sections 26011.5 and 26131, Business and Professions Code.

§40243. Equipment and Utensils.

Licensees shall utilize equipment and utensils that meet the following minimum requirements:
§ 40243 (a) Design. 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.
§ 40243 (b) Installation. Equipment shall be installed so as to allow the 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.
§ 40243 (c) Cleaning, sanitizing, and maintenance. 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 procedure, including a log, for documentation of the date and time of maintenance, cleaning, and sanitizing of equipment and utensils; and
(4) A detailed, written procedure for storing cleaned and sanitized equipment and utensils in a manner to protect the equipment and utensils from contamination.

Authority: Sections 26012, 26013 and 26130, Business and Professions Code.
Reference: Sections 26011.5 and 26131, Business and Professions Code.

§40246. Personnel.

Licensees shall implement written procedures for personnel that include, at minimum:
§ 40246 (a) 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 (such as boils, sores, cut, rash, or infected wounds) 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 health condition is corrected. Personnel shall be instructed to report such health conditions to their supervisors.
§ 40246 (b) Cleanliness. All individuals working in direct contact with cannabis products, 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:
(1) Wearing clean outer clothing to protect against allergen cross-contact and contamination of cannabis products, contact surfaces, and packaging materials;
(2) Washing hands thoroughly in a hand-washing facility that meets the requirements of Section 40240 before starting work, after each absence from the work station, and at any time when the hands may have become soiled or contaminated;
(3) Removing all unsecured jewelry and other objects that might fall into cannabis products, 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 which can be maintained in an intact, clean, and sanitary condition and which effectively protects against the contamination by these objects of the cannabis products, contact surfaces, or cannabis product-packaging materials;
(4) Maintaining any gloves, if they are used in cannabis product handling, in an intact, clean, and sanitary condition;
(5) Wearing hair nets, caps, beard covers, or other hair restraints that are designed and worn to prevent hair contact with cannabis, cannabis products, contact surfaces, or packaging materials;
(6) Storing clothing and personal belongings in areas separate from those where cannabis products are exposed or where equipment or utensils are washed;
(7) 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;
§ 40246 (c) Nothing in this section prohibits a licensee from establishing any other precautions to protect against allergen cross-contact and against contamination of cannabis products, contact surfaces, or packaging materials by microorganisms or foreign substances (including perspiration, hair, cosmetics, tobacco, chemicals, and medicines applied to the skin).

Authority: Sections 26012, 26013 and 26130, Business and Professions Code.
Reference: Sections 26011.5 and 26131, Business and Professions Code.

§40248. Cannabis Product Components.

§ 40248 (a) In order to prevent adulteration of cannabis products, licensees shall establish and implement written policies and procedures to ensure and maintain the quality of product components.
§ 40248 (b) Components are subject to the following minimum requirements:
(1) Raw materials and other components shall be inspected upon intake to ensure that they are clean and suitable for processing into cannabis products, and shall be stored under conditions that protect against allergen cross-contact and contamination, and in such a way as to minimize deterioration.
(2) 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.
(3) 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.
(4) 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 finished cannabis products.
(5) Raw materials and other components shall be held in containers designed and constructed so as to protect against allergen cross-contact or contamination, and shall be held at such temperature and relative humidity and in such a manner as to prevent the cannabis products from becoming adulterated.
(6) 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.
(7) 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.
§ 40248 (c) Holding and storage of raw materials and other components shall meet the requirements of section 114047, subdivisions (a) and (b), section 114049, and section 114051 of the Health and Safety Code.

Authority: Sections 26012, 26013 and 26130, Business and Professions Code.
Reference: Sections 26011.5 and 26131, Business and Professions Code.

§40250. Manufacturing Processes and Procedures.

§ 40250 (a) The licensee shall implement and maintain manufacturing processes and procedures that ensure cannabis product quality. Manufacturing processes and procedures shall be identified through a product quality plan, as described in Section 40253.
§ 40250 (b) The licensee shall maintain written master manufacturing protocols, as described in Section 40255, 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 these regulations.
§ 40250 (c) The licensee shall maintain written batch production records, as described in Section 40258, 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.
§ 40250 (d) All manufacturing records are subject to inspection by the Department, its inspectors and agents.

Authority: Sections 26012, 26013 and 26130, Business and Professions Code.
Reference: Sections 26011.5 and 26131, Business and Professions Code.

§40253. Product Quality Plan.

§ 40253 (a) Licensees shall create 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.

§ 40253 (b) To create the product quality plan, licensees shall conduct a comprehensive assessment of the overall manufacturing process, identifying each step from component intake through transfer of product from the premises, to determine the potential risks associated with each step, the preventive measures to mitigate the potential risks identified, the methods to evaluate and monitor the effectiveness of the preventive measures, and action to take if a preventive measure was unsuccessful.

§ 40253 (c) The product quality plan shall evaluate the following potential risks to cannabis product quality:

(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;

(4) Process failures that may lead to product contamination, allergen cross-contact, packaging errors, labeling errors, or other errors affecting cannabis product quality.

§ 40253 (d) The product quality plan shall identify the preventive measure that will be implemented 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;

(4) Implementing procedures to ensure homogeneity of cannabinoids into a cannabis product to mitigate against the risk of a non-homogeneous product.

§ 40253 (e) The product quality plan shall identify 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;

(3) Conducting environmental testing to determine if equipment or utensils are contaminated with pathogens;

(4) Monitoring the temperature of raw materials that need to be held below 41 degrees Fahrenheit to prevent microbial contamination.

§ 40253 (f) The product quality plan shall identify actions to be taken if the evaluation and monitoring of the preventive measure indicates that the 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 that may be taken include,
but are not limited to:

(1) Destruction of product components or finished product;

(2) Further processing of cannabis extract to remove impurities;

(3) Reworking the unfinished product to further homogenize the cannabinoids.

§ 40253 (g) The licensee 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 26012, 26013 and 26130, Business and Professions Code.
Reference: Sections 26011.5 and 26131, Business and Professions Code.

§40255. Master Manufacturing Protocol.

§ 40255 (a) The licensee 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 against the potential for adulteration through incorporation of incorrect amounts of cannabinoids, unintended ingredients, or hazards identified in the product quality plan; against the potential for misbranding through incorporation of ingredients not identified on the label or the mislabeling of product; and to ensure uniformity in finished batches and across all batches produced.

§ 40255 (b) The master manufacturing protocol shall include:

(1) Destruction of product components or finished product;

(2) Further processing of cannabis extract to remove impurities;

(3) Reworking the unfinished product to further homogenize the cannabinoids.

§ 40255 (c) 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 26012, 26013 and 26130, Business and Professions Code.
Reference: Sections 26011.5 and 26131, Business and Professions Code.

§40258. Batch Production Record.

§ 40258 (a) The licensee shall prepare a written batch production record every time a batch of a cannabis product is manufactured. 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.

§ 40258 (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 equipment and processing lines used in producing the batch;

(3) The date and time of the maintenance, cleaning, and sanitizing of the equipment and processing lines used in producing the batch, or a cross-reference to records, such as individual equipment logs, where this information is retained;

(4) The identification number assigned to each component, packaging, and label used, and, if applicable, to a cannabis product received from another licensee for packaging or labeling as a cannabis product;

(5) The identity and weight or measure of each component used;

(6) A statement of the actual yield and a statement of the percentage of expected yield at appropriate phases of processing;

(7) The actual results obtained during any monitoring operation;

(8) The results of any testing or examination performed during the batch production, or a cross-reference to such results; and

(9) 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 persons performing each step, including:

(i) The initials of the person responsible for weighing or measuring each component used in the batch;

(ii) The initials of the person responsible for verifying the weight or measure of each component used in the batch;

(iii) The initials of the person responsible for adding the component to the batch; and

(iv) The initials of the person responsible for verifying the addition of components to the batch.

(10) Documentation, at the time of performance, of packaging and labeling
operations, including:

(A) An actual or representative label, or a cross-reference to the physical location of the actual or representative label specified in the master manufacturing record;
(B) The expected number of packaging and labels to be used, the actual quantity of the packaging and labels used, and, when label reconciliation is required, reconciliation of any discrepancies between issuance and use of labels; and
(C) The results of any tests or examinations conducted on packaged and labeled cannabis products (including repackaged or relabeled cannabis products), or a crossreference to the physical location of such results.
(11) 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;
(D) Either approved and released, or rejected, the batch for distribution; and
(E) Either approved and released, or rejected, the finished cannabis product, including any repackaged or relabeled cannabis product.
(12) Documentation, at the time of performance, of any required material review and disposition decision; and
(13) The Certificate of Analysis issued for the batch by the licensed testing laboratory, which shall be added to the record after regulatory compliance testing has been completed.

§ 40258 (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; and

(4) Be as detailed as necessary to provide a history of work performed; including:

(A) Information to identify any associated manufacturing premises (e.g., the name,
license number, and the location of the premises);

(B) The date and the time of the activity documented;

(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 26012, 26013 and 26130, Business and Professions Code.
Reference: Sections 26011.5 and 26131, Business and Professions Code.

Article 5. Special Processing Requirements

§40270. Juice Processing.

§ 40270 (a) Requirements of this section shall apply to manufacturers of cannabis juice, and cannabis-infused juice or beverages.

§ 40270 (b) 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 21 CFR, Part 120, subpart A, section 120.8, and subpart B, section 120.24, (Rev. January 2001), which is hereby incorporated by reference.

Authority: Sections 26012, 26013 and 26130, Business and Professions Code.
Reference: Sections 26011.5 and 26131, Business and Professions Code.

§40272. Dried Meat Processing.

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 processing into dried meat products shall be acquired from a commercially-available source.

Authority: Sections 26012, 26013 and 26130, Business and Professions Code.
Reference: Sections 26011.5 and 26131, Business and Professions Code.

Article 6. Other Responsibilities

§40275. Standard Operating Procedures.

§ 40275 (a) A licensee 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 40200;

(2) Emergency response procedures, including safety data sheets for any chemicals on-site;

(3) Policies and procedures developed in accordance with Section 40225;

(4) Policies and procedures developed in accordance with Article 3 of this subchapter (Good Manufacturing Practices);

(5) Procedures for complying with the track-and-trace requirements established in Article 2 of subchapter 6;

(6) Inventory control procedures in compliance with Section 40282; and

(7) Cannabis waste management procedures in compliance with Section 40290.

§ 40275 (b) Procedures shall be written in English but may be made available in other languages, as necessary for the licensee’s personnel.

Authority: Sections 26012, 26013 and 26130, Business and Professions Code.
Reference: Sections 26011.5, 26130 and 26160, Business and Professions Code.

§40277. Weights and Measures.

§ 40277 (a) Weighing devices used by a licensee shall be approved, tested, and sealed in accordance with the requirements in Chapter 5 (commencing with section 12500) of Division 5 of the Business and Professions Code, and registered with the county sealer consistent with Chapter 2 (commencing with section 12240) of Division 5 of the Business and Professions Code. Approved and registered devices shall be used 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 section 12500 of the Business and Professions Code.

§ 40277 (b) For the purposes of this chapter, “count” means the numerical count of the individual cannabis product units.

§ 40277 (c) 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 as required by Chapter 7 (commencing with section 12700) of Division 5 of the Business and Professions Code. The weighmaster certificate required under section 12711 of the Business and Professions Code shall not be required when cannabis or cannabis products are weighed for entry into the track-and-trace system.

Authority: Sections 26012, 26013 and 26130, Business and Professions Code.
Reference: Sections 26011.5 and 26060, Business and Professions Code.

§40280. Training Program.

§ 40280 (a) The licensee shall 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) Manufacturing and production personnel, 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) The product quality plans developed in accordance with Section 40253;

(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 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. The licensee shall obtain documentation evidencing the fulfillment of this requirement;

(4) The licensee shall ensure that all personnel receive annual refresher training to cover, at minimum, the topics listed in this subsection. This annual refresher training must be completed within 12 months of the previous training completion date.

§ 40280 (b) The licensee shall maintain a record of training which contains 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;

(3) The signature of each individual personnel 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.

§ 40280 (c) The 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 he or she has received and understands all information that will be provided to individual personnel in the training program. This documentation shall be maintained as part of the record requirements.

§ 40280 (d) For licensees in operation pursuant to Section 40126, applicable personnel shall receive required training no later than 90 days after the effective date of the annual license.

Authority: Sections 26012, 26013 and 26130, Business and Professions Code.
Reference: Sections 26011.5, 26130 and 26160, Business and Professions Code.

§40282. Inventory Control – Cannabis and Cannabis Products.

§ 40282 (a) A licensee 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.

§ 40282 (b) A licensee shall reconcile the on-hand inventory of cannabis and cannabis products at the licensed premises with the records in the track-and-trace database at least once every thirty (30) calendar days.

§ 40282 (c) If a licensee finds a discrepancy between the on-hand inventory and the trackand-trace database, the licensee shall conduct an audit.

§ 40282 (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 notify the Department within 24 hours of the discovery.

Authority: Sections 26012, 26013 and 26130, Business and Professions Code.
Reference: Sections 26011.5 and 26130, Business and Professions Code.

§40290. Waste Management.

§ 40290 (a) A licensee shall have a written cannabis waste management plan and shall dispose of all waste, including cannabis waste, in accordance with the Public Resources Code and any other applicable state and local laws, including laws regulating “organic waste” as defined in Public Resources Code section 42649.8(c). 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 section 40141 of the Public Resources Code.

§ 40290 (b) A licensee shall dispose of any cannabis waste in a secured waste receptacle or secured area on the licensed premises. For the purposes of this section, “secured waste receptacle” or “secured area” means that physical access to the receptacle or area is 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. Public access to the designated receptacle or area shall be prohibited.

§ 40290 (c) No cannabis product shall be disposed of in its packaging, and all cannabis waste shall be unrecognizable and unusable as cannabis or a cannabis product at the time of disposal. Nothing in this subsection shall be construed to require waste vape cartridges to be emptied of cannabis oil prior to disposal, provided that the vape cartridge is itself unrecognizable and unusable at the time of disposal.

§ 40290 (d) Cannabis waste shall be entered into the track-and-trace system as required under Section 40512.

§ 40290 (e) Cannabis waste may be collected from a licensee in conjunction with a regular organic waste collection route used by the local agency, a waste hauler franchised or contracted by the local agency, or a private waste hauler permitted by the local agency. If a local agency, a waste hauler franchised or contracted by the local agency, or a private waste hauler permitted by the local agency is being used to collect and process cannabis waste, a licensee 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.

§ 40290 (f) 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 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; or

(D) A manned fully permitted transfer/processing facility or manned transfer/processing operation.

(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.

Authority: Sections 26012, 26013 and 26130, Business and Professions Code.
Reference: Sections 26011.5, 26013 and 26130, Business and Professions Code.

§40292. Consent to Sample Collection.

A manufacturer licensee that transfers possession but not title of cannabis products to a licensed distributor shall allow the Bureau, upon the Bureau’s request, to collect samples for purposes of conducting oversight of licensed testing laboratories.

Authority: Sections 26012, 26013 and 26130, Business and Professions Code.
Reference: Sections 26011.5, 26013 and 26130, Business and Professions Code.

§40295. Product Complaints.

§ 40295 (a) The licensee shall establish and implement written procedures to ensure that: 

(1) A qualified individual shall review and investigate all product complaints to determine whether such complaints involve a possible failure of a cannabis product to meet any of its specifications;

(2) Quality control personnel shall review and approve decisions determining whether to investigate a product complaint and shall review and approve the findings and follow up action(s) of any investigation performed;

(3) Pursuant to subsections (a) and (b) in this section, any review or investigative activities by qualified individuals and quality control personnel shall extend to all relevant batches and records.

(4) Quality control personnel shall maintain written records for every product complaint and subsequent investigation, if any. The records shall include:

(A) The name and description of the cannabis product;

(B) The batch number or UID of the cannabis product, if available;

(C) The date the complaint was received and the name, address, and telephone number of the complainant, if available;

(D) The nature of the complaint including, if known, how the product was used;

(E) The reply to the complainant, if any;

(F) The findings of the investigation or follow-up action taken when an investigation is performed; and

(G) The basis for any determination not to conduct an investigation.

§ 40295 (b) For purposes of this section, “product complaint” means any written, electronic, or oral communication that contains any allegation expressing concern, for any reason, with the quality of a cannabis product that could be related to the manufacturing practices. Examples of product complaints may include but are not limited to: foul odor, off taste, illness or injury, disintegration time, color variation, foreign material in a cannabis product container, improper packaging, mislabeling, cannabis products that contain an incorrect concentration of cannabinoids, or cannabis products that contain an unidentified ingredient, or any form of contaminant.

Authority: Sections 26012, 26013 and 26130, Business and Professions Code.
Reference: Sections 26011.5 and 26131, Business and Professions Code.

§40297. Recalls.

§ 40297 (a) Licensees shall establish and implement written procedures for recalling cannabis products manufactured by the licensee that are determined to be misbranded or adulterated. These procedures shall include:

(1) Factors which 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 product, including communication and outreach via media, as necessary and appropriate;

(B) A mechanism to notify any licensees that supplied or received the recalled product;

(C) Instructions to the general public and other licensees for the return or destruction of the recalled product.

(4) Procedures for the collection and destruction of any recalled product. Such procedures shall meet the following requirements:

(A) All recalled products that are intended to be destroyed shall be quarantined for a minimum of 72 hours. The licensee shall affix to the recalled products any bills of lading, shipping manifests, or other similar documents with product information and weight. The product held in quarantine shall be subject to auditing by the Department.

(B) Following the quarantine period, the licensee shall render the recalled cannabis product unusable and unrecognizable and dispose of it in accordance with Section 40290, and do so on video surveillance in accordance with Section 40205.

§ 40297 (b) In addition to the tracking requirements set forth in Section 40512, a licensee shall use the track-and-trace database and on-site documentation to ensure that recalled cannabis products 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 products, the licensee shall enter the following details into the track-and-trace database: the weight and count of the product, reason for destruction, and the date the quarantine period will begin.

§ 40297 (c) The licensee shall notify the Department of any recall within 24 hours of initiating the recall.

Authority: Sections 26012, 26013 and 26130, Business and Professions Code.
Reference: Sections 26011.5 and 26131, Business and Professions Code.

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