BILL ANALYSIS Ó AB 34 Page 1 Date of Hearing: April 28, 2015 ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS Susan Bonilla, Chair AB 34 (Bonta and Jones-Sawyer) - As Amended April 23, 2015 SUBJECT: Medical cannabis regulation and enforcement. SUMMARY: Establishes a licensing and regulatory framework for medical cannabis under the Medical Cannabis Regulation and Control Act, and would establish the Division of Medical Cannabis Regulation and Enforcement within the Department of Alcoholic Beverage Control (ABC), the Division of Medical Cannabis Manufacturing and Testing within the State Department of Public Health (CDPH), and the Division of Medical Cannabis Cultivation within the Department of Food and Agriculture (CDFA), and would set forth the duties of the respective regulatory authorities. EXISTING LAW: 1)Recognizes the authority of cities and counties to make and enforce, within their borders, all local, police, sanitary, and other ordinances and regulations not in conflict with general interest laws. (Cal. Const. Art. XI Sec. 7) 2)Licenses and regulates physicians and surgeons under the Medical Practice Act (Act) by the Medical Board of California (MBC), within the Department of Consumer Affairs (DCA). AB 34 Page 2 (Business and Professions Code (BPC) Section 2000 et seq.) 3)Requires the MBC to prioritize its investigative and prosecutorial resources to ensure that physicians representing the greatest threat of harm are identified and disciplined expeditiously and includes in that prioritization list: "Repeated acts of clearly excessive prescribing, furnishing, or administering of controlled substances, or repeated acts of prescribing, dispensing, or furnishing of controlled substances without a good faith prior examination of the patient and medical reason therefor." (BPC Section 2220.05) 4)Prohibits the possession, possession with intent to sell, cultivation, sale, transportation, importation, or furnishing of marijuana, except as otherwise provided by law. (Health and Safety Code (HSC) Sections 11357, 11358, 11359, and 11360) 5)Prohibits prosecution under the Compassionate Use Act of 1996 (CUA), an initiative measure, for the possession or cultivation of marijuana of a patient or a patient's primary caregiver who possesses or cultivates marijuana for the personal medical purposes of the patient upon the written or oral recommendation or approval of a physician. (HSC Section 11362.5) 6)States that nothing in the CUA shall be construed to supersede legislation prohibiting persons from engaging in conduct that endangers others, or to condone the diversion of marijuana for non-medical purposes. (HSC Section 11362.5(b)(2)) 7)Provides that no physician in California shall be punished, or denied any right or privilege, for having recommended marijuana to a patient for medical purposes. (HSC Section 11362.5(c)) 8)Defines "attending physician" as an individual who possesses a license in good standing to practice medicine or osteopathy issued by the MBC or the Osteopathic Medical Board of California and who has taken responsibility for an aspect of AB 34 Page 3 the medical care, treatment, diagnosis, counseling, or referral of a patient and who has conducted a medical examination of that patient before recording in the patient's medical record the physician's assessment of whether the patient has a serious medical condition and whether the medical use of marijuana is appropriate. (HSC Section 11362.7(a)) 9)Defines "primary caregiver" for purposes of the CUA as the individual designated by a patient who has consistently assumed responsibility for the housing, health, or safety of that person. (HSC Section 11362.7(d)) 10)Requires the CDPH to establish and maintain a voluntary Medical Marijuana Program for qualified patients to apply for identification cards, and county health departments to issue identification cards to qualified patients and their caregivers. (HSC Section 11362.7 et seq.) 11)Requires a person who seeks an identification card to pay a fee and provide to the county health department the person's name, proof of residency, written documentation by the attending physician in the person's medical records stating that the person has been diagnosed with a serious medical condition and that the medical use of marijuana is appropriate, and the doctor's name, contact information, and California medical license number, as specified. (HSC Section 11362.715(a)) 12)Makes it a misdemeanor offense to, among other things, fraudulently represent a medical condition or provide any material misinformation to a physician, health department designee, or to law enforcement, for the purpose or falsely obtaining an identification card; counterfeit, tamper with, or fraudulently produce an identification card; or breach any confidentiality requirements pertaining to an identification card program. (HSC Section 11362.81) 13)Provides that qualified patients, persons with valid AB 34 Page 4 identification cards, and their designated primary caregivers who associate in order to collectively or cooperatively to cultivate marijuana are not subject to criminal liability solely on that basis. (HSC Section 11362.775) THIS BILL: General Provisions 1)Establishes the Medical Cannabis Regulation and Control Act (Act). 2)Provides that, without limiting the authority of a city or county pursuant to Section 7 of Article XI of the California Constitution, and subject to that authority, the state shall have the exclusive right and power to regulate and license persons for the cultivation, manufacture, transportation, sale, and other related activities regarding medical cannabis in the state. 3)Defines the following terms: a) "Regulatory authority" means the Division of Medical Cannabis Regulation and Enforcement within the ABC, the Division of Medical Cannabis Manufacturing and Testing within the CDPH, or the Division of Medical Cannabis Cultivation within the CDFA, as appropriate to the context; b) "Division" means the Division of Medical Cannabis Regulation and Enforcement within the ABC; c) "Commercial cannabis activity" means any cultivation, AB 34 Page 5 possession, manufacture, processing, storing, laboratory testing, labeling, transporting, distributing, or sale of cannabis or cannabis product, except as specified; d) "Medical cannabis product," "medical marijuana product," or "cannabis product" means any product containing cannabis, including, but not limited to, concentrates and extractions intended to be sold for use by medical marijuana patients in California pursuant to the Compassionate Use Act of 1996 (Proposition 215); e) "Manufactured cannabis" means raw marijuana that has undergone a process whereby the raw agricultural product has been transformed into a concentrate, an edible product, or a topical product; f) "Dispensary" means a retail location that distributes cannabis or medical cannabis products and is owned and operated by a licensee; g) "Testing and labeling" means a labeling and quality assurance plan that addresses all of the following: potency; chemical residue; microbiological contaminants; handling, care, and storage; and date and location of cultivation, processing, and manufacturing; h) "Cultivation site" means a location that grows cannabis or medical cannabis products and is owned and operated by a licensee, including a nursery; i) "Cultivation" means any activity involving the planting, growing, harvesting, drying, processing, or trimming of cannabis; and, AB 34 Page 6 4)Provides that the Act does not prevent a city or county from doing any of the following: a) Adopting local ordinances inconsistent with the Act that do the following: i) Regulate the location, operation, or establishment of a licensee or any person that cultivates, processes, possesses, stores, manufactures, tests, transports, distributes, or sells medical cannabis. ii) Prohibit commercial cannabis activity within their jurisdiction. b) Administrative, civil or criminal enforcement of the ordinances described under a), or establishing a fee or tax for the operation of a licensee within its jurisdiction; or, c) Enacting and enforcing other laws or ordinances pursuant to the authority granted by Section 7 of Article XI of the California Constitution. State Framework 5)Establishes the Division of Medical Cannabis Regulation and Enforcement within the ABC, and requires the Division to: AB 34 Page 7 a) Be administered by a person who is appointed by the Director of the ABC, and administer the Act, as it pertains to commercial cannabis activity relating to dispensaries. b) Lead all state and local authorities regarding the tracking of medical cannabis, medical cannabis products and licensees pursuant to the Act. c) Maintain a registry of all permit holders and shall maintain a record of all licensees and commercial cannabis activity of the permit holder throughout the length of licensure and for a minimum of seven years following the expiration of the licensure. d) Keep a complete record of all entities licensed pursuant to the Act, which shall be made available on the Division's Internet Web site so as to permit state and local law enforcement to verify a mandatory commercial license. e) Develop a database containing electronic shipping manifests, as specified, and designed to flag irregularities for any regulatory authority to investigate. f) Adopt regulations regarding the minimum standards for the operation of dispensaries, including: i) A requirement that dispensaries provide patients with detailed written information about the contents of the cannabis and medical cannabis products they obtain; AB 34 Page 8 ii) Requirements for inventory control and reporting that require all dispensaries to be able to demonstrate the present location, amounts, and descriptions of all medical cannabis products from the time of delivery to the dispensary until purchase by a qualified patient or primary caregiver; iii) Minimum educational and testing requirements for licensee staff, including, but not limited to, background checks and a requirement that every dispensary maintain dedicated, licensed security staff both inside and outside the dispensary; iv) Minimum standards governing signage and advertising for dispensaries. g) Commencing 180 days after the Division begins issuing provisional licenses, only allows a dispensary to provide patients medical cannabis and medical cannabis products obtained only from persons licensed under the Act. 6)Establishes the Division of Medical Cannabis Manufacturing and Testing within the CDPH, and requires it to: a) Be administered by a person who is appointed by the State Health Officer and administer the Act as it pertains to manufacturing, testing, and certification of testing laboratories for medical cannabis, and adopt regulations that: i) Establish product labeling and packaging standards and requirements that require manufactured cannabis AB 34 Page 9 products to include: (1) A label to include the manufacturing date, name of the mandatory commercial licensee from which it was obtained, the active ingredients, net weight, cannabinoid profile, nutritional facts, dosage in total milligrams of cannabinoids delivered, and any potential allergens. (2) Warning that state, "KEEP OUT OF REACH OF CHILDREN AND ANIMALS" and "FOR MEDICAL USE ONLY." (3) Clear indication in bold font that the package contains medical cannabis. The package shall not be designed in a manner that attracts minors. (4) Standards that clearly distinguish edible cannabis products from non-cannabis products. (5) The name of the mandatory commercial licensee that manufactured the product. ii) Establish consumer protection, food and product safety requirements, including: (1) Adverse event reporting and product recall systems and the requirement that employees who manufacture or handle edible cannabis products to thoroughly wash their hands; (2) Standards for cannabinoid dosage in edible AB 34 Page 10 products; (3) Sanitation standards equivalent to the California Retail Food Code for food preparation, storage, handling, and sale of medical cannabis products; (4) A requirement that edible medical cannabis products be limited to foods that are not potentially hazardous food; (5) Weighing or measuring standards, as specified; (6) Standards controlling the application of pesticides; and, (7) A requirement that all edible medical cannabis products be individually wrapped at the original point of preparation. iii) Establish testing requirements for all medical cannabis and medical cannabis products, including: (1) Testing for the active cannabinoid profile, constituent elements, and microbiological, bacterial, pathogenic yeast, and mold counts; (2) Testing standards by which to test and measure the potency of medical cannabis and medical cannabis products. The Division of Medical Cannabis AB 34 Page 11 Manufacturing and Testing shall also determine maximum potency standards in the potency of medical cannabis and medical cannabis products; (3) Testing standards by which to test and measure the quality of medical cannabis and medical cannabis products; and, (4) Protocols for medical cannabis and medical cannabis product testing. iv) Establish procedures for certifying laboratories for the testing of medical cannabis and medical cannabis products, which shall be consistent with general requirements for the competence of testing and calibration activities, as specified. b) Ensure licensed cannabis cultivation entities have access to existing agricultural incentive and support programs. 7)Establishes the Division of Medical Cannabis Cultivation within the CDFA, and requires it to: a) Adopt regulations, in consultation with the Department of Water Resources to ensure that commercial cannabis activity does not threaten the state's clean water and environment. b) Adopt regulations ensuring that the cultivation of cannabis under the Act is in compliance with the standards equivalent to the statutory and regulatory requirements AB 34 Page 12 applicable to the production of a food crop, including: i) Cultivation protocols ensuring the quality, availability, and safety of the cannabis crop, including both indoor and outdoor cultivation standards and regulations regarding carbon offsets for indoor cultivation; and, ii) Environmentally sound agricultural practices, including a requirement that any actual or potential for, environmental damage be addressed by the relevant state agency; a provision authoring revocation of a license if the state determines that the conduct of the licensee threatens to inflict or has inflicted significant damage to the environment; and standards controlling the application of pesticides; c) Adopt regulations to establish cultivation labeling and packaging standards and requirements, including, but not limited to, cultivation labeling requirements requiring labeling to include cannabinoid levels, cannabinoid profile, and active ingredients. 8)Requires each regulatory entity to adopt regulations as needed to implement the licensing program within one year following the establishment of a provisional license, as specified, which shall not limit the authority of a city or a county pursuant to Section 7 of Article XI of the California Constitution, or any other law, and require the regulations to: a) Establish a scale of application, licensing, and renewal fees, based upon the cost of enforcing the Act, as specified; AB 34 Page 13 b) Establish procedures for the approval or denial of applications for commercial cannabis activity; c) Establish applicant qualifications and licensee employee qualifications, including training and screening requirements, and licensee security requirements, including procedures to limit access to facilities and to prevent diversion of product to nonmedical use; d) Establish procedures and protocols for identifying, managing, and disposing of contaminated, adulterated, deteriorated, or excess product and advertising, marketing, signage, and labeling requirements and restrictions; e) Establish procedures for the suspension, revocation, or surrender of a license and establishing related fines and penalties for violations; Licensing Framework 9)Exempts from licensure a patient who cultivates, possesses, stores, manufactures, or transports medical cannabis only for his her personal medical use, or a primary caregiver who does so only for the personal medical purposes of his or her specified qualified patient, as specified. 10)Provides that 180 days after the issuance of provisional licenses under the Act, that criminal immunity for qualified patients, persons with valid identification card, and the designated primary caregivers of qualified patients and persons with identification cards who collectively and AB 34 Page 14 cooperatively cultivate marijuana for medical purposes shall not apply to licenses under the Act. 11)Requires the regulatory authority to issue licenses to applicants to engage in commercial cannabis activity pursuant to the Act, and prohibits persons from engaging in commercial cannabis activity unless the person obtains permission from local authorities, as specified. 12)Prohibits a person from engaging in commercial cannabis activity unless the person: a) Obtains permission from local authorities, and requires the document granting permission to include: i) Legal name, address, and date of birth of the applicant and the type of license the applicant is requesting a permit for; ii) Documentation that the applicant has been in compliance with local ordinances and regulations, including, but not limited to, an entity granted immunity under Measure D, as specified; iii) A statement of whether or not the applicant has previously committed a drug trafficking, serious, or violent felony, a felony involving fraud or deceit or any other felony, as determined by the Division; and iv) A statement signed by the applicant under penalty of perjury that the information provided in the application is true. AB 34 Page 15 b) Provides that this requirement for permission from local authorities does not apply to a person who holds a valid business license, conditional use permit, or other locally issued permit for commercial cannabis activity; c) Submits a copy of the permission, or equivalent qualifying documents, to the Division for recordation, and requires the Division, upon receipt of an approved permission, to provide the applicant with a certificate of approval for licensure, to be presented to the relevant regulatory authority under which the person seeks licensure. Prohibits a regulatory authority from granting approval of an application without a certificate of approval; d) Applies for licensure from commercial cannabis activity from a regulatory authority and receives approval for that licensure; and e) Abides by all local and state ordinances and regulations pursuant to the Act. 13)Provides that an application for licensure shall include: a) A certificate of approval for licensure by the Division. b) The legal name and proposed physical addresses of the mandatory commercial licensee, and the name, address, and date of each principal officer and board member, and a list of all persons or entities having an ownership interest AB 34 Page 16 other than a security interest, lien, or encumbrances on any property that will be used by the applicant, and evidence that all of the officers and owners have been residents of the State of California for at least three years. c) Operating and inventory control procedures to ensure security and prevent diversion, and detailed operating procedures for the proposed facility, which shall include provisions for facility and operational security, prevention of diversion, employee screening, storage of medical cannabis, personnel policies, and recordkeeping procedures. d) Evidence of the legal right to occupy and use an established location, or immunity from prosecution for that occupancy or use pursuant to a local ordinance, as specified, and documentation that the applicant will be in compliance with all local ordinances and regulations, as specified. e) A statement signed by the applicant under penalty of perjury that the information provided in the application is true. 14)For applicants seeking a license to cultivate and process, the application shall also include a detailed description of the operating procedures for: cultivation; extraction and infusion methods; transportation process; inventory procedures; and quality control procedures. 15)Requires regulatory authorities, upon receipt of an application and fee, to make a thorough investigation to determine whether the applicant and the premises for which a AB 34 Page 17 license is applied qualify for a license and whether the Act has been complied with. 16)Authorizes a regulatory authority to place reasonable conditions upon licensure if grounds exist for denial of the license and the Division finds those grounds may be removed by the imposition of those conditions. Provides that specified limitations shall not be waived. 17)Requires a regulatory authority to deny a license or renewal of a license if: a) Granting or continuation of a license would be contrary to the public welfare or morals, or the applicant or license holder has violated any law prohibiting conduct involving moral turpitude. b) Local agencies have notified the Division and provided evidence that the licensee or applicant within its jurisdiction is in violation of local ordinances relating to cannabis activities. c) The applicant fails to meet the requirements of the Act or any regulation adopted pursuant to the Act, or any applicable city or county ordinance or regulation. d) The applicant, or any of its officers, directors, or owners, has been convicted of a felony criminal conviction for drug trafficking, a violent felony, a serious felony, a felony involved fraud or deceit, or any other felony, as determined by the Division. AB 34 Page 18 e) The applicant has been sanctioned by the Division or a local government for unlicensed medical cannabis activities or has had a license revoked in the last three years. 18)Requires the regulatory authority to submit to the Department of Justice fingerprint images and related information for all license applicants. 19)Requires regulatory authorities to adopt regulations establishing tiered licensing schemes to accommodate the different levels and types of activities to be licensed, as specified. 20)Requires the regulations to set forth the application and licensing process, including, but not limited to: a) A description of the various specific forms of commercial cannabis activity to be authorized by the various types of licenses and the establishment of the license application, issuance, renewal, suspension, surrender, and revocation procedures for the various types of licenses to be issued; b) Procedures for the issuance, renewal, suspension, and revocation of mandatory commercial licenses, and time periods not to exceed 90 days by which the Division shall approve or deny an application; and c) Qualifications for licensees and security requirements. 21)Provides that each application approved by the respective licensing authority is separate and distinct, and requires AB 34 Page 19 each approved license application to be reported to the Division within 24 hours. 22)Requires each regulatory authority to adopt, as soon as practicable, emergency regulations consistent with the Act to allow a qualified applicant for licensure to apply for, and receive, a provisional license to engage in commercial cannabis activity so as to ensure an adequate supply of medical cannabis upon full implementation of the Act. 23)Requires each regulatory authority to, as soon as practicable, allow a qualified applicant for licensure to apply for and receive a provisional license, and establish appropriate fees. 24)Requires each regulatory authority to issue a provisional license to individuals and entities the authority determines were, during the three months prior to January 1, 2016, regularly cultivating, processing, manufacturing, transporting, or distributing medical cannabis collectively or cooperatively in full compliance with any applicable local ordinance to continue to do so unless the licensee's application has been approved or denied, but not later than 90 days after the authority begins accepting applications for regular licenses. 25)Beginning July 1, 2017, all commercial cannabis activity shall be conducted between licensees of commercial cannabis activity pursuant to the Act, except as specified. Enforcement 26)Requires state agencies to collaborate with local agencies, AB 34 Page 20 and local agencies, within the scope of their jurisdiction, and to the extent resources are available, to assist state agencies in the enforcement of the Act, as specified. 27)Requires regulations to set forth the inspection and enforcement responsibilities of the ABC, CDPH, Division of Labor Standards Enforcement, Department of Water Resources, and CDFA associated with the Act. 28)Requires the regulatory authority to enter into an interagency agreement with the ABC, the DCA, the Division of Labor Standards and Enforcement, the Department of Water Resources, the CDPH, and the CDFA setting forth the duties of those agencies under the Act and providing for reimbursement to the appropriate state and local authorities of associated costs from revenues deposited into the fees account of the fund. 29)Provides that the regulatory directors and the persons employed by the regulatory authorities for the administration and enforcement of the Act are peace officers in the enforcement of the penal provisions of the Act, the rules of the division adopted under the Act, and any other penal provisions of law in the state prohibiting or regulating the cultivation, processing, storing, manufacturing, testing, transporting, or selling of medical cannabis, and these persons are authorized, while acting as peace officers, to enforce any penal provisions of state law while in the course of their employment. 30)Provides that regulatory directors, persons employed by regulatory authorities, and peace officers, as specified, while acting in the course and scope of their employment as peace officers, may, in enforcing this chapter, visit and inspect the premises of any licensee at any time during which AB 34 Page 21 the licensee is acting pursuant to the mandatory commercial license. 31)Provides that the actions of a licensee that are within the scope of the license issued pursuant to the Act and the regulations adopted pursuant to the authority granted by the Act are not unlawful under state law and shall not be an offense subject to arrest, prosecution, or other sanction under state law, or subject to a civil fine. 32)Provides that conduct within the scope of a license but not fully in compliance with this chapter shall not be subject to the enforcement provisions of the Act and shall not be subject to the penal provisions generally prohibited cannabis-related activity, unless and until the license is revoked. 33)Requires each regulatory authority to work in conjunction with law enforcement agencies for the purposes of implementing, administering, and enforcing the Act and the Division's regulations and taking appropriate action against licensees and others who fail to comply with the Act or regulations adopted pursuant to the Act. 34)Provides that nothing in the Act, or other related laws, shall prevent a local government from adopting or enforcing a zoning ordinance or other law, ordinance, or regulation that regulates the location, operation, or establishment of a license or other person that engages in commercial cannabis activity. 35)Provides that if a person engages in commercial cannabis activity and operates an unlicensed facility, building, structure, or location in violation of the Act is subject to unspecified civil penalties. AB 34 Page 22 36)Requires a state or local agency to immediately notify the Division of any violations or arrests made for violations over which the Division has jurisdiction which involve a licensee or licensed premises. 37)Authorizes a local government to impose a temporary local suspension of the license of a commercial licensee for up to 30 days for violations of the Act, and may impose a subsequent temporary local suspension of the license for the same violation until the regulatory authority's investigation and all appeals are complete. Medical Cannabis Control Fund 38)Establishes the Medical Cannabis Control Fund within the State Treasury. 39)Provides that all fees collected under the Act be deposited into the fees account, which shall be established within the fund and continuously appropriated to the Division solely for the purposes of fully funding and administering the Act, including the costs incurred by the Division for its administrative expenses and costs and the costs of all regulatory authorization, as specified. 40)Requires all monies collected under the Act as fines or penalties be deposited into the fines and penalties account, which shall be available, upon appropriation, for purposes of funding the enforcement grant program. 41)Requires the regulatory authorizes to collaboratively AB 34 Page 23 establish and administer a grant program to allocate moneys from the fines and penalties account to state and local entities for the purpose of assisting with medical cannabis regulation and the enforcement of the Act and other state and local laws. 42)Requires the total fees charged pursuant to the Act to be sufficient to pay the costs associated with the administrative and enforcement duties of the Division and of the associated state agencies in administering the Act. Health and Safety Standards 43) Requires the Department of Transportation to conduct research regarding determining whether a driver is operating a vehicle under the influence of cannabis, and to develop protocols setting forth best practices to assist law enforcement agencies. 44)Requires regulations on the cultivation of medical cannabis to: a) Require the licensee to comply with all regulations of the CDFA pursuant to the Act regarding the cultivation of medical cannabis and any other applicable requirements of the Division pursuant to the Act. b) Requires licensees to track all cannabis products and report to the Division. c) Requires all medical cannabis to be tested by a laboratory that has been certified and licensed pursuant to AB 34 Page 24 the Act prior to commercial exchange with a dispensary. 45)Requires regulations on the testing of medical cannabis to: a) Prohibit a testing licensee from receiving medical cannabis products except through a regulatory authority or licensee. b) Prohibit a licensee from being licensed for any other activity authorized under licensing provisions, and from holding an ownership interest in any property or assets associated or used in any other license category. 46)Requires regulations on the manufacturing of medical cannabis to: a) Require the manufacturing licensee to comply with all regulations of the CDPH regarding the cultivation of medical cannabis and any other applicable requirement of the Division. b) Require licensees to track all cannabis products and report to the Division. c) Require all manufactured medical cannabis and medical cannabis products to be tested by a laboratory that is certified and licensed pursuant to the Act prior to commercial exchange with a dispensary. 47)Requires regulations on the dispensing of medical cannabis to: AB 34 Page 25 a) Require the dispensary licensee to comply with all regulations of the Division regarding the dispensary of medical cannabis and any other applicable requirements of the Division pursuant to the Act. b) Allow dispensary licensees to store limited quantities of medical cannabis and medical cannabis products for commercial purposes pursuant to the act. c) Allow all non-mobile, non-vehicular, and non-Internet-based dispensaries to be licensed to transport medical cannabis and medical cannabis products directly to consumers. d) Require all mobile, vehicular and Internet-based dispensaries to maintain a business contract with a non-vehicular and non-mobile dispensary, and report all records of commercial activity to that entity. e) Require licensees to track all medical cannabis and medical cannabis products and report to the Division. f) Require that, upon receipt of medical cannabis or medical cannabis products, the dispensary licensee shall request and record evidence that the product has been tested by a laboratory that has been certified and licensed. 48)Requires regulations for the wholesale of medical cannabis to: AB 34 Page 26 a) Require all wholesale licensees to comply with all regulations of the Division regarding the wholesale storage and distribution of medical cannabis. b) Establish criteria for the qualifications, including maximum amounts of medical cannabis that can be stored. c) Require that all medical cannabis and medical cannabis products be tested by the wholesale licensee prior to commercial exchange with a dispensary. d) Requires licensees to track all medical cannabis and medical cannabis products and report to the Division. Recordkeeping, Security, and Transportation Standards. 49)Requires a licensee to keep accurate records of the specific commercial cannabis activity conducted by the licensee, as specified. 50)Authorizes the division to make any examination of the books and records of any licensee and to inspect and visit the premises of the licensee, and if a licensee or its employee refuses or impedes an inspection, or fails to maintain the books or records, the license may be summarily suspended, as specified. 51)Requires all cultivation, dispensing, and retail sales licensees to be subject to an annual audit by the State Auditor in order to ensure proper documentation is kept at each site or facility. AB 34 Page 27 52)Requires a licensee authorized to transport medical cannabis and medical cannabis products to: a) Prior to transport, complete an electronic shipping manifest, as prescribed by the Division, and to securely transmit the manifest to the Division and the licensee that will receive the shipment. b) During transportation, maintain a physical copy of the shipping manifest and make it available to agents of the Division, local law enforcement, or any other designated enforcement agency. 53)Requires a licensee receiving the shipment to maintain each electronic shipping manifest and make it available to agents of the Division, local law enforcement, or any other designated enforcement agency and submit to the Division a record verifying receipt of the shipment and details of the shipment. 54)Requires transported medical cannabis or medical cannabis products worth more than $500 dollars at retail to be transported only in secured storage compartments, as specified. 55)Requires, for licensees transporting medical cannabis with a retail value of over $5,000, transport vehicles to be staffed with a minimum of two employees. AB 34 Page 28 Taxation 56)Authorizes the regulatory authorities to assist state taxation authorities in the development of uniform policies for the state taxation of mandatory commercial licensees. 57)Requires licensees to obtain a seller's permit from the Board of Equalization to validate the authority of the licensee to sell medical cannabis or medical cannabis products to another licensee. 58)Requires licensees to obtain a resale certificate upon the sale of medical cannabis or medical cannabis to another licensee, to track the quantities exchanged. 59)Authorizes the Board of Supervisors in any county to impose, by ordinance, a tax on the privilege of cultivating, dispensing, producing, processing, preparing, storing, providing, donating, selling or distributing cannabis by a licensee, as specified. Labor Provisions. 60)Requires the Division of Labor Standards Enforcement (Division) to: a) Maintain minimum standards for the competency and training of employees of licensed cultivator or dispensary through a system of testing and certification; AB 34 Page 29 b) Establish registration fees in an amount reasonably necessary to implement this article, not to exceed $25 for initial registration. c) By January 1, 2017, develop a certification program for cannabis employees, and commencing January 1, 2019, require certification for all persons who perform work as cannabis employees, except as specified. d) By January 1, 2017, convene an advisory committee to evaluate whether there is a need to develop industry-specific regulations related to the activities of licensees. e) By July 1, 2017, require the advisory committee to present its findings and recommendations to the Board of the Division of Occupational Safety and Health in the Department of Industrial Relations, and requires the Board to render a decision regarding the adopting of these regulations. 61)Beginning January 1, 2019, establishes additional grounds for disciplinary proceedings, including suspension or revocation of a license issued under the Act, as specified, and requires the Division of Labor Standards Enforcement to refer cases to the appropriate regulatory authority when it is determined that a violation has occurred, as specified, and requires the regulatory authority to open an investigation and take disciplinary action within 60 days of receipt of the referral. AB 34 Page 30 62)Requires the Division of Apprenticeship Standards to investigate, approve, or reject applications for apprenticeship programs for employees of a licensed cultivator or dispensary, as specified. Physician Provisions 63)Requires the MBC to prioritize cases involving physicians who recommend marijuana to patients for medical purposes without a good faith prior examination of the patient and medical reason therefor. 64)Makes it unprofessional conduct to prescribe or recommend marijuana to a patient for a medical purpose without an appropriate prior examination and a medical indication, or to be employed by, or have an agreement with, a mandatory commercial licensee acting pursuant to the Act or a dispensary to provide recommendations for medical marijuana. FISCAL EFFECT: Unknown. This bill is keyed fiscal by the Legislative Counsel. COMMENTS 1)Purpose. This bill is author-sponsored. According to the author: "In 1996, California made history by becoming the first state in the nation to allow the use of medical cannabis after voters approved Proposition 215. However, in the past two decades, California has fallen behind the nation and AB 34 Page 31 failed to implement a comprehensive licensing and regulatory structure to ensure patient access and protect our environment, public safety, and public health. AB 34 would fulfill the promise made to the people of California back in 1996 by creating the structure in which patients can safely exercise their right to medical cannabis. AB 34 approaches regulation of medical cannabis with one core method-apply existing regulatory frameworks to this new industry while adapting for the unique and historical circumstances surrounding medical cannabis. To this end, the bill divides the licensing structure among multiple agencies that have expertise in various industries that have similarities to that of medical cannabis, in addition to requiring these agencies to promulgate appropriate regulations for the medical cannabis industry. AB 34 also ensures that all licensees and transactions between them are tracked in order to fight diversion of medical cannabis. AB 34 recognizes that for too long, cities and counties have been on the leading edge of crafting medical cannabis policies when faced with murky state law and contradictory federal priorities. That is why this bill respects local decisions on the regulation of medical cannabis-including the decision to ban-and incorporates local control throughout the regulatory process, including the issuance and renewal of state licenses. AB 34 protects patients by requiring compliance with stringent regulatory requirements, preserves the environment and protects water resources by building on the existing interagency taskforce work in this field, and ensures that workers in the cannabis industry are treated fairly and receive equal protections under the labor code. AB 34 combines the input of stakeholders throughout the state to create thoughtful, effective regulations that fit within our existing regulatory frameworks for other products, comply with federal goals, and create a better system for the entire life cycle of the medical cannabis treatment." AB 34 Page 32 2)Background. The Compassionate Use Act (CUA) and SB 420. In 1996, voters approved the CUA, which allowed patients and primary caregivers to obtain and use medical marijuana, as recommended by a physician, and prohibited physicians from being punished or denied any right or privilege for making a medical marijuana recommendation to a patient. In 2003, SB 420 (Vasconcellos), Chapter 875, Statutes of 2003, established the Medical Marijuana Program (MMP), which allowed patients and primary caregivers to collectively and cooperatively cultivate medical marijuana, and established a medical marijuana card program for patients to use on a voluntary basis. The card can be used to verify that a patient has authorization to possess, grow, transport, or use medical marijuana in California, and that a caregiver has authorization to possess, grow, and transport medical marijuana in California. The MMP facilitates the registration of qualified patients and their caregivers through a statewide identification system, and qualified patients and their caregivers may apply for and be issued an identification card through their county of residence. Upon issuance of the card, it is registered with an online database which law enforcement can use to verify whether a card is valid. Under the MPP, a person is required to get a recommendation for medical marijuana from an attending physician, which is defined to mean someone who, "? has taken responsibility for an aspect of the medical care, treatment, diagnosis, counseling, or referral of a patient and who has conducted a medical examination of that patient before recording in the patient's medical record the physician's assessment of whether the patient has a serious medical condition and whether the medical use of marijuana is appropriate." Written documentation of this recommendation is required to be submitted to the county in order to receive a medical AB 34 Page 33 marijuana card. Since Proposition 215 and SB 420, however, the state has not adopted a framework to provide for appropriate licensure and regulation of medical marijuana. As a result, in the nearly 20 years since the passage of Proposition 215, there has been an explosion of medical marijuana collectives and cooperatives that are largely left to the enforcement of local governments, resulting in a patchwork for regulations for these industries and with little statewide involvement. The California Attorney General's Compassionate Use Guidelines. SB 420 required the California Attorney General to "develop and adopt appropriate guidelines to ensure the security and non-diversion of marijuana grown for medical use by patients qualified under the Compassionate Use Act of 1996." In 2008, the Attorney General issued guidelines to: 1) ensure that marijuana grown for medical purposes remains secure and does not find its way to non-patients or illicit markets, 2) help law enforcement agencies perform their duties effectively and in accordance with California law, and 3) help patients and primary caregivers understand how they may cultivate, transport, possess, and use medical marijuana under California law. According to a 2011 letter, after a series of meeting with stakeholders to assess whether to clarify the 2008 guidelines to stop the exploitation of California's medical marijuana laws by gangs, criminal enterprises, and others, the Attorney General decided to postpone the issuance of new guidelines because of pending litigation and to urge the Legislature to amend the law to establish clear rules governing access to medical marijuana. California Supreme Court Affirms Local Control Over Medical Marijuana. By exempting qualified patients and caregivers from prosecution for using or from collectively or cooperatively cultivating medical marijuana, the CUA and the MPP essentially authorized the collective and cooperative system for medical marijuana. These laws have triggered the growth of medical marijuana dispensaries in many localities, and in response, local governments have sought to exercise AB 34 Page 34 their police powers to regulate or ban activities relating to medical marijuana. After numerous court cases and years of uncertainty relating to the ability of local governments to control medical marijuana activities, particularly relating to the ability to control the zoning, operation, and existence of medical marijuana dispensaries, the California Supreme Court, in City of Riverside v. Inland Empire Patients (2013) 56 Cal.4th 729, held that California's medical marijuana statutes do not preempt a local ban on facilities that distribute medical marijuana. The court held that nothing in the CUA or the MMP expressly or impliedly limited the inherent authority of a local jurisdiction, by its own ordinances, to regulate the use of its land, including the authority to provide that facilities for the distribution of medical marijuana will not be permitted to operate within its borders. Federal Controlled Substances Act. Despite the CUA and SB 420, marijuana is still illegal under state and federal law. Under California law, marijuana is listed as a hallucinogenic substance in Schedule I of the California Uniform Controlled Substances Act. Yet, the CUA prohibits prosecution for obtaining, distributing, or using marijuana for medical purposes. However, under the federal Controlled Substances Act, it is unlawful for any person to manufacture, distribute, dispense or possess a controlled substance, including marijuana, whether or not it is for a medical purpose. As a result, patients, caregivers, and dispensary operators who engage in activities relating to medical marijuana may still vulnerable to federal arrest and prosecution. According to the California Attorney General's guidelines, the difference between state and federal law gives rise to confusion. However, California has tried to avoid this conflict not by legalizing medical marijuana, but by deciding not to use the state's powers to punish certain marijuana offenses under state law when a physician has recommended its use to treat a serious medical condition. U.S. Department of Justice (US DOJ) Guidance Regarding Marijuana Enforcement. On August 29, 2013, the US DOJ issued AB 34 Page 35 a memorandum (Cole Memo) that updated its guidance to all U.S. Attorneys in light of state ballot initiatives to legalize under state law the possession of small amounts of marijuana and provide for the regulation of marijuana production, processing, and sale. While the memorandum noted that illegal distribution and sale of marijuana is a serious crime that provides a significant source of revenue to large-scale criminal enterprises, gangs, and cartels, it also noted that the US DOJ is committed to using its limited investigative and prosecutorial resources to address the most significant threats, which include: preventing distribution to minors; preventing revenue from marijuana from going to criminal enterprises; preventing diversion to other states where marijuana is not legal under state law; preventing state-authorized marijuana from being a cover for trafficking in other illegal drugs or illegal activity; preventing violence in cultivating and distributing marijuana; preventing drugged driving and other public health problems from marijuana use; and preventing growing, possessing or using marijuana on public lands or on federal property. According to the US DOJ, "In jurisdictions that have enacted laws legalizing marijuana in some form and that have also implemented strong and effective regulatory and enforcement systems to control the cultivation, distribution, sale, and possession of marijuana, conduct in compliance with those laws and regulations is less likely to threaten the federal priorities set forth above?In those circumstances, consistent with the traditional allocation of federal-state efforts in this area, enforcement of state law by state and local law enforcement and regulatory bodies should remain the primary means of addressing marijuana-related activity." Medical Marijuana Industry in California. According to the author's Sunrise Questionnaire, there are no feasible means to quantify the total number of medical cannabis practitioners in California due to the unregulated nature of the industry. In addition, although California has exercised its traditional power to regulate the practice of medicine and has determined that marijuana has medicinal properties that play a AB 34 Page 36 significant role in medicine, marijuana is currently listed as a Schedule I drug under federal law; therefore it has been difficult for California practitioners within the field of medicinal cannabis to work under standard business practices without risking action from federal enforcement authorities. However, according to the Emerald Growers Association, there are an estimated 30,000 cultivation sites alone in the tri-county area of Humboldt-Mendocino-Trinity. According to numerous estimates, the California cannabis industry is in the billions of dollars, and there are a reported 1.5 million medical cannabis patients. Need for Regulation. California has recognized the medicinal value of cannabis and therefore all industry practices relating to providing medical cannabis for the treatment of medical conditions for qualified patients should be allowed under state law. However, according to the author, in the nearly two decades since the passage of Proposition 215, it is clear that California remains very much in the Wild West of medical marijuana. Due to the lack of statewide regulations, practitioners within the medical cannabis industry create their own standards (e.g., labeling, potency, quality assurance, content, dosage etc.). While certain partners within the industry may collaborate with each other, there is no statewide standard AB 34 Page 37 for practitioners to make professional judgments of consequence. The lack of regulations results in practitioners making these decisions on a daily basis during their business practices. The consequences can be that some products either do not meet or exceed current standards for other similar products within related industries. For example, some manufactured edible cannabis products that are being sold to patients may not have gone through the same stringent food retail and safety standards as other foods, which may risk harm for consumers. While some facilities may test their products for mold, pesticides, or contaminants, without licensing or certification standards for that testing, the same product at two different locations can yield vastly different results, which pose risk of harm to consumers, especially when dealing with patients who may be immunosuppressed or otherwise vulnerable. In addition, medical cannabis cultivation has recently received significant attention within the media because of its utilization of scarce water supplies in the midst of a drought and associated environmental impacts from water diversion and pesticide use. The author's proposed regulatory structure would fund enforcement of existing standards, while also requiring legitimate licensees to comply with state and local environmental regulations. Due to the lack of regulation, some actors have also been encouraged to operate at the edge of the law and in the grey area between state and federal rules. This has reduced consumer protections, worker protections, impacted business operations, and even banking services, to name just a few areas which have been harmed by regulatory uncertainty. Furthermore, the lack of statewide standards regarding suitability for receiving a license, when combined with a patchwork of local ordinances that have made it difficult for legitimate operators to engage in business above board, and AB 34 Page 38 provided a competitive advantage to the black market operators. Without such standards, there are no market controls, and no standards for consume protection. While there have been some moves towards self-regulation, such as the development of testing laboratories which work solely on medical cannabis, by and large the legal uncertainty has severely hindered protection of the public welfare. There is also the harm and the threat of federal action looming over California patients and practitioners until the state has enacted the comprehensive and robust regulatory system as demanded in the Cole Memo described above. Until such a comprehensive regulatory scheme is enacted, the medical marijuana industry will continue to swing between two unacceptable extremes of having no oversight or regulations, to being subject to federal action despite compliance with local laws. According to the author, only comprehensive, rigorous regulations for medical cannabis will overcome potential harm to consumers and the industry. AB 34 Licensing and Regulatory Framework. This bill will address the above concerns by doing all of the following: Establishing a comprehensive licensure and regulatory scheme for medical cannabis activities, including for dispensaries, wholesalers, manufacturers, and testing laboratories, including minimum standards for operation. Requires the Division of Medical Cannabis Regulation and Enforcement to lead all state and local authorities AB 34 Page 39 regarding the tracking of medical cannabis, medical cannabis products and licensees. Establishes standards for manufacturers, testing, and certification of testing laboratories for medical cannabis, including establishing product labeling and packaging standards for cannabis products, and establishing consumer protection, food and product safety requirements, including those relating to dosage and sanitation, and testing for potency and for bacteria, yeast, and mold. Establishes standards for cultivators, including meeting regulations to ensure that commercial cannabis activity does not threaten the state's clean water and environment. Ensures patient access to care by establishing a provisional license program, continuing to exempt patients and caregivers, and establishing tiered licensing schemes to accommodate different levels and types of activities. Maintains local authority by prohibiting persons from engaging in commercial cannabis activity unless the person obtains permission from local authorities. Establishes a grant program to allocate monies to state and local entities for purposes of assisting with regulation and enforcement. AB 34 Page 40 According to the author, while many of these standards are for the health and safety of the public, arguably if all were implemented it would go beyond freedom from harm and instead improve the lives of patients and the public. These proposals would also allow a vast and economically vibrant industry to thrive in a regulated fashion protected from the federal government. The economic benefits from this regulation-stimulating the local and state economy, providing significant tax revenues, and helping patients live more productive lives-are above and beyond the protections provided by these regulations. Marijuana Frameworks Established in Other States. California is the only state that permits for medical marijuana in the absence of a robust state-wide regulatory system. The following states have state-wide medical marijuana regulatory systems: Alaska, Arizona, Colorado, Washington DC, Delaware, Hawaii, Illinois, Maine, Maryland, Massachusetts, Michigan, Minnesota, Montana, Nevada; New Hampshire, New Jersey, New Mexico, New York, Oregon, Rhode Island, Vermont and Washington. In addition, Colorado, Washington and Oregon have established recreational marijuana licensing schemes. Both Washington and Colorado have created systems of legal production and sale, subject to licensing, regulation and taxation. However, the laws impose different industry structures and build on their existing medical systems in different ways. Colorado allows entrepreneurs to produce cannabis and sell it at retail, and such businesses are, at least initially, required to produce the majority of the pot they sell (vertical integration), while Washington state maintains clear separation between pot growers, processors and retailers (horizontal integration). Both models seek to, AB 34 Page 41 however, reduce diversion and increase accountability. In addition, the commercial market in Washington is supervised by the Washington State Liquor Control Board, while Colorado's law vests authority to regulate the commercial market in the newly created Marijuana Enforcement Division of the Department of Revenue. Colorado's medical marijuana program is also under that Division - prior to the recreational initiative, the Medical Marijuana Enforcement Division was regulating that part of the market. According to the Brookings Institution, since the early 1990s, U.S. public opinion has trended in favor of marijuana legalization. Currently, a majority of Americans support legalization by a margin of seven points-52 percent to 45 percent, according to findings from a Pew Research Center survey in March 2013. Support for marijuana legalization has risen sharply since 2010, by 11 percentage points. This increasing support for marijuana legalization is present in California as well, with recent polls showing that a majority of Californians support marijuana legalization. There are an estimated four different marijuana initiatives attempting to qualify for the 2016 ballot. In order for any marijuana scheme to be effective, it should address all parts of the industry, including establishing a robust licensing and regulatory scheme, a taxation scheme, incorporate health and safety standards, in addition to ensuring that the public is protected; however, if the measure is too prescriptive, it may hamper the ability to address any unintended consequences or fill in any policy gaps without having to go back to the ballot. As a result, if the State is able to create a comprehensive framework for medical marijuana, it may also serve a dual role by serving as a basis for a recreational marijuana scheme. 1)Current Related Legislation. AB 26 (Jones-Sawyer) of the current legislative session, would enact the Medical Cannabis Regulation and Control Act to license and regulate medical AB 34 Page 42 cannabis, and would create the Division of Medical Cannabis Regulation and Enforcement within the Department of Alcoholic Beverage Control to administer the act. (STATUS: This bill is in the Assembly Business and Professions Committee.) AB 34 (Bonta) of the current legislation, session would enact the Medical Cannabis Regulation and Control Act to license and regulate medical cannabis, and would establish the Division of Medical Cannabis Regulation and Enforcement within the Department of Alcoholic Beverage Control to administer the act. (STATUS: This bill is in the Assembly Business and Professions Committee.) AB 243 (Wood) of the current legislation session, would require all medical marijuana cultivation (MMC) to be conducted in accordance with state and local laws and best practices, as specified, and would require state agencies to address environmental impacts of MMC and coordinate with local governments in enforcement efforts, and establishes a MMC permitting system. (STATUS: This bill is in the Assembly Environmental Safety and Toxic Materials Committee.) SB 673 (McGuire) of the current legislation session, would establish within the Department of Consumer Affairs a Bureau of Medical Marijuana Regulation, under the supervision and control of the Chief of the Bureau of Medical Marijuana Regulation, and would require the bureau to license and regulate dispensing facilities, cultivation sites, transporters, and manufacturers of medical marijuana and medical marijuana products, subject to local ordinances, and enforced primarily at the local level. (STATUS: This bill is in the Senate Governance and Finance Committee.) 2)Prior Related Legislation. AB 1262 (Correa) of 2014, would have established a licensing and regulatory framework for the cultivation, processing, transportation, testing, AB 34 Page 43 recommendation and sale of medical marijuana to be administered by the Department of Consumer Affairs (DCA) and enforced primarily at the local level. (NOTE: This bill was held in the Assembly Appropriations Committee.) AB 1894 (Ammiano) of 2014, would have enacted the Medical Cannabis Regulation and Control Act to license and regulate the cultivation, manufacture, testing, transportation, storage, distribution, and sale of medical cannabis, and would create the Division of Medical Cannabis Regulation and Enforcement within the Department of Alcoholic Beverage Control. (NOTE: This bill was held on the Assembly Floor.) AB 473 (Ammiano) of 2013, would have enacted the Medical Marijuana Regulation and Control Act to license and regulate the cultivation, manufacturing, testing, transportation, distribution, and sales of medical marijuana and medical marijuana products, and would create the Division of Medical Marijuana Regulation and Enforcement within the Department of Alcoholic Beverage Control. (NOTE: This bill was held on the Assembly Floor.) AB 604 (Ammiano) of 2013, would have enacted the Medical Cannabis Regulation and Control Act to license and regulate the cultivation, manufacture, testing, transportation, storage, distribution, and sale of medical cannabis, and would create the Division of Medical Cannabis Regulation and Enforcement within ABC. (NOTE: This bill was held in the Senate Public Safety Committee.) AB 2312 (Ammiano) of 2012, would have established the Medical Marijuana Regulation and Control Act, authorizing local taxes on medical cannabis and creating a board to regulate the medical cannabis industry. (NOTE: This bill was held in the Senate Committee on Business, Professions and Economic Development.) AB 34 Page 44 SB 1182 (Leno) of 2012, would have provided that a cooperative or collective that operates within the Attorney General's (AG) guidelines shall not be subject to prosecution for marijuana possession or commerce, as specified. (NOTE: This bill was held on the Senate Floor.) AB 1300 (Blumenfield), Chapter 196, Statutes of 2011, provided that a local government entity may enact an ordinance regulating the location, operation or establishment of a medical marijuana cooperative or collective; authorizes local government entities to enforce such ordinances through civil or criminal remedies and actions; and authorizes a local government entity to enact any ordinance that is consistent with the Medical Marijuana Program. SB 626 (Calderon) of 2011 would have required the Board of Equalization (BOE) to establish a nine-member task force to conduct a study to determine ways to enhance collections of sales and use taxes on retail sales of marijuana and ensure proper regulation of the cultivation, transportation, and distribution of marijuana and marijuana products. (NOTE: This bill was held in the Senate Appropriations Committee.) AB 390 (Ammiano) of 2009, would have legalized the possession, sale, cultivation and other conduct relating to marijuana and required the Department of Alcoholic Beverage Control to administer and enforce the terms of legalized marijuana. (NOTE: This bill was held in the Assembly Health Committee.) SB 420 (Vasconcellos), Chapter 875, Statutes of 2003, established the Medical Marijuana Program Act, a statewide, voluntary program for the issuance of identification cards to identify persons authorized to engage in the medical use of marijuana under the Compassionate Use Act. Proposition 215, of the November 1996 General Election, prohibits prosecution for the possession and cultivation of AB 34 Page 45 cannabis by a patient or a patient's primary caregiver with a physician's written or oral recommendation. ARGUMENTS IN SUPPORT The Emerald Growers Association writes in support, "The bill takes a measured approach to this complex public policy challenge. AB 34 identifies regulatory agencies, calls on those agencies to develop a system of licensure, and - most importantly from our perspective-calls on the [CDFA] to take a lead role regulating cultivation?.By referring many of the specific details to future legislation and regulatory processes, this bill empowers stakeholders to form stronger relationships and gain a deeper understanding of other perspectives?There is no other major industry in CA that is regulated entirely by one agency and past attempts to fit the entire industry into the oversight of a single industry have failed. The multi-agency approach ensures that agencies are only responsible for regulating things they are capable of regulating?.[This bill] calls on the regulatory authorities to establish a tiered licensing scheme to accommodate the different levels and types of activity to be licensed. This will create opportunities for small, medium, and large businesses to participate in the regulated industry and ensure the most expeditious transition to regulation with minimum disruption to regional economies." United Food and Commercial Workers Union writes a letter in support and states, "a 'cannabis worker apprenticeship program and certification program' will ensure the rights of workers are AB 34 Page 46 protected, health and safety standards are maintained and ongoing product knowledge and skills development are sustained with consistency throughout the cannabis industry similar to pharmacy laboratory technicians, nursing assistants, dental hygienists, physical therapists, and cosmetologists." ARGUMENTS IN OPPOSITION The League of California Cities writes in opposition: "Despite provisions in the bill appearing to uphold local regulations, the bill also contains provisions that clearly undermine the power of local ordinances, setting the stage for future litigation on this issue, should this measure be enacted unchanged?.[C]onflicting provisions raise the question of whether AB 34 is serious about upholding local control in the context of a regulatory scheme for medical marijuana. First, this measure places the [ABC] in overall charge of the regulatory scheme?As a matter of policy, the League is convinced that in a state the size of California, no state agency should have the primary role of enforcement in the field of marijuana regulation - the cost to the state will be excessive and the enforcement in too many instances will be neither timely nor AB 34 Page 47 sufficient ?.Second, there is no local licensing under AB 34's regulatory scheme?Third, AB 34 authorizes locals to temporarily suspend a license, but the authorization flows from ABC?Fourth,?language calls into question the validity of pre-existing local bans?.Each of these provisions sets the stage for future litigation, pitting local governments against the state, and against industry participants who have attempted to set up shop in many of our cities in direct violation of local ordinances." The California Police Chiefs Association writes in opposition: "[W]e do not believe that the ABC is an appropriate administrative department for medical marijuana regulation. We have serious concerns regarding the efficacy of state enforcement and instead advocate for an enforcement structure based off of local enforcement with state enforcement being secondary. Furthermore, we do not believe that an agency with profound experience in recreational substance has the appropriate expertise to regulate a medical product?We believed that AB 34 as currently constructed, erodes the authority of cities and counties to prohibit medical marijuana operations in their jurisdiction?AB 34 appears to downgrade drug trafficking to a misdemeanor?" POLICY ISSUES FOR CONSIDERATION: This bill would establish a novel licensing and regulatory AB 34 Page 48 scheme for medical cannabis, which covers nearly every aspect of the medical cannabis industry, from seed to sale. To accomplish this scheme, the bill creates three new divisions within three different state departments, and carves out the responsibilities and jurisdiction of each one. Wholesalers and dispensaries are licensed under the Division of Medical Cannabis Regulation and Enforcement (DMCRE), under the ABC; manufacturers and testing laboratories are under the Division of Medical Cannabis Manufacturing and Testing (DMCMT), under the CDPH; and cultivators are licensed under the Division of Medical Cannabis Cultivation under the CDFA, all collectively known as the "regulatory authorities." Each of these newly-created divisions have myriad duties involved in this comprehensive new scheme, which include establishing new standards for licensure, in addition to comprehensive health and safety and environmental standards. Each division is responsible for enforcement of their respective areas. As would be expected for any new regulatory program of this scale and scope, let alone three new programs, a number of outstanding issues and overarching concerns should be addressed to ensure that this framework has the greatest chance of success, the key of which is likely to be coordination and collaboration among the regulatory authorities. In addition, successful implementation of any medical cannabis program will require strong leadership and involvement from the Administration to prioritize implementation so that it meets federal guidance and prevents the potential for illegitimate activities; to coordinate efforts among all regulatory authorities and other state entities that will play a role in establishing a robust and effective licensing and regulatory framework; and to ensure that all of the regulatory authorities will have sufficient resources to ensure that staffing and other needs will be met. AB 34 Page 49 Division of Medical Cannabis Regulation and Enforcement (DMCRE) Under the ABC. ABC has the exclusive right and power to license and regulate the manufacture, importation, and sale of alcoholic beverages. ABC is authorized 427 positions, organized into three major division and twenty-four district offices, to regulate the 87,112 ABC-licensed businesses. The licensing section investigates all applicants and proposed business locations to ensure they meet minimum qualifications, and may examine police problems, over concentration of licensed premises in the area, and the possible impact the proposed business will have on nearby residences, churches, schools, and hospitals. Currently, the ABC has over seventy licensing categories that are established in statute. While most of the ABC authority for licensure and enforcement is explicit in statute, the ABC has the authority to promulgate rules to effectively implement its mission and purpose. ABC agents are peace officers and are empowered to investigate and make arrests for violations that occur on or about licensed premises. The ABC employs various methods of enforcement, often collaborating with other agencies to enforce the provisions in the ABC Act including minor-decoy operations, fake identification stings known as "Operation Trapdoor," and complaint-driven investigations. Agents are further empowered to enforce any penal provisions of the law any place in the State. However, the ABC relies on local law enforcement to police the provisions within the ABC Act for approximately 40-50% of its enforcement functions. Regardless of the agency filing the violation, licensees who violate state laws or local ordinances are subject to disciplinary action and may have their licenses suspended or revoked. These licensees are entitled to a hearing before an Administrative Law Judge and an appellate AB 34 Page 50 process to the State Supreme Court. While it appears that the ABC has an infrastructure in place to support these additional licensing and enforcement activities relating to medical cannabis, the author may wish to consider the extent to which the proposed licensing and enforcement should parallel and be modeled after the licensure and enforcement provisions for alcohol, particularly with regards to local involvement during the licensure process, tiers of licensure categories, and the number of licenses a licensee may ahold across different activities. In addition, the author may wish to specify the type of enforcement the ABC is intended to have, and clarify the role of enforcement and sharing of enforcement responsibility between ABC and local governments, and whether the medical cannabis program should have a similar appeals process. In addition, the ABC's jurisdiction and operations are primarily guided by statute; the ABC does not promulgate many of its regulations. In light of the ABC's broad new jurisdiction under this bill, the author should continue to build upon the framework in this bill to ensure that the ABC's primary role is in implementing these laws, and not creating policy with respect to these laws. In addition, the author may wish to specify that the DMCRE roles with respect to medical cannabis is to promote patient safety and legitimate access to care. AB 34 Page 51 Laboratory Certification. The DMCMT, under CDPH, would be required to license and regulate manufacturers and testing laboratories, in addition to establishing complex and comprehensive health and safety standards, including standards relating to product labeling, food and product safety requirements, maximum potency for cannabinoids, sanitization standards, and testing standards. Many of these areas build upon the CDPH's existing jurisdiction and areas of expertise. The CDPH operates some licensing and certification programs for food and drugs under its Food and Drug Branch, establishes health and safety standards under the Food Safety Program, and is responsible for promulgating certification regulations and certifies some laboratories. The International Laboratory Accreditation Cooperation (ILAC) is a well-respected industry organization that has several accreditation bodies that are considered complaint with ISO/IEC 17011, which is the standard by which accreditation bodies are to operate, and are qualified to attest that a laboratory meets the standards found in ISO/IEC 17025 and ISO/EIC 17020 (which is the visual inspection standard). For example, the American Association for Laboratory Accreditation in Maryland is an ILAC-approved accreditation body that has developed a Cannabis Testing Laboratory Program specifically designed to raise the standard in laboratory testing relating to medical marijuana. As a result, the author should consider whether laboratory certification using an outside accreditation body may be a more appropriate or specify that DMCMT may rely upon an outside accreditation body as part of its certification. The licensee could then be charged with using a certified laboratory or face sanctions for failure to comply with the requirement that an accredited laboratory was utilized, thereby limiting the administrative oversight of the division, is appropriate. AB 34 Page 52 Establishing a Taskforce. Because the structure requires multiple new divisions, each with oversight over their respective licensees and possible overlap (because the licensing structure does not limit the number of licensees an entity might have), there will be a need for great communication and collaboration among the regulatory entities and other state and local entities that play a role in licensing and enforcement. For example, if one entity took action against a licensee, that action should be communicated to any other regulatory entity or relevant local entity, and the possibility of joint enforcement actions may be considered. The bill serves to create such communication by, among other things, requiring the DMCRE to serve as a repository of information for all licensees, and requiring such actions to be reported to the DMCRE. In addition, the bill requires regulations that set forth the inspection and enforcement responsibilities of each relevant state entity, and requires the regulatory authorities to enter into an interagency agreement to set forth the duties of those agencies under the Act and provide for reimbursement to the appropriate state and local authorities of associated costs from revenues deposited into the fees account of the fund. To build upon these efforts to increase communication, ensure a coordinated front, and reduce duplicative efforts, the author may wish to consider establishing a taskforce to clarify the appropriate roles of each state entity, and establish clear communication and information sharing guidelines. Such a taskforce could also bolster each regulatory authorities regulatory efforts by inviting outside expertise, such as including other environmental departments, medical cannabis or industry experts, and local enforcement and licensing entities. Other participants may also include the Board of Equalization AB 34 Page 53 and the Attorney General, to help navigate state and federal legal landscapes. Information Database. The bill would require the DMCRE to lead all state and local authorities regarding the tracking of medical cannabis, medical cannabis products, and licensees pursuant to the Act; maintain a registry of all licensees and records of all licensees; maintain all electronic shipping manifests; and share the above information with state and local law enforcement. Based on the state's spotted history with complex information technology projects, the author should consider working early on with the ABC and other relevant state entities to determine the feasibility, timeline, and cost to establish a database system that would meet these new requirements. Multiple Licenses. Under the bill, licensees can hold multiple license types, except it cannot combine a testing laboratory with any other license. This approach is similar to Colorado's approach, which initially required "vertical integration," or requires businesses to be involved in all parts of the business to get a license. This approach was thought to initially limit the number of businesses, making it easier to control the market, and allowed additional licensees to enter the market at a later time. Washington, on the other hand, prohibited "vertical integration" and instead only permitted business to get licensed in one stage of production, similar, for the most part, to the alcohol control model. The intent behind that model was to avoid the creation of monopolies, and some also believe that structure makes it harder to licensees to falsify any data. Currently, the bill allows licensees to hold multiple AB 34 Page 54 licensees, but does not require a licensee to be involved in all parts of the business; instead, it allows for both types of models. The author may wish to consider the benefits of both approaches, and whether it may be beneficial at some point to limit the number of licensees one can hold. Use of Peace Officers. The bill provides that regulatory directors and persons employed by the regulatory authorities for the administration and enforcement of the Act are peace officers in the enforcement of the penal provisions of the Act, the rules of the division adopted under the Act, and any other relevant penal provisions. While many state entities use sworn officers, the language in the bill raises the question of whether all persons employed by the divisions for administration and enforcement need to be sworn officers. For example, ABC agents are peace officers and are empowered to investigate and make arrests for violations of the BPC that occur on or about licensed premises, but less complex tasks, such as license applications, are reviewed and processed by non-sworn licensing representatives. The author may wish to clarify that the regulatory authorities also rely on non-sworn personnel. Enforcement. The bill vests primary responsibility to regulate medical cannabis with the State, and requires each regulatory authority to enforce their own provisions. However, the bill also requires state agencies to collaborate with local agencies, and local agencies, within the scope of their jurisdiction, and to the extent resources are available, to assist state agencies in the enforcement of the Act. In addition, the bill requires the regulatory authorities to collaboratively establish and administer a grant program to allocate moneys from the fines and AB 34 Page 55 penalties account to state and local entities for the purpose of assisting with medical cannabis regulation and the enforcement. While the regulatory authorities are clearly tasked with enforcement responsibilities, many of these entities work with local law and code enforcement or local health and agricultural offices to enforce health and safety and other standards. The author may wish to consider clarifying these instances and opportunities for collaboration. Fund. While the bill authorizes regulatory authorities to establish a fee for provisional licensees, it does not provide any further guidance about how a regulatory authority can support its startup costs. The author may wish to consider whether the state entity housing each new division is able to advance those startup costs as a loan. In addition, the author should consider establishing a separate fee account for each regulatory authority to enable it to deposit fees and penalties it collects and to also draw upon those funds. Appointments. Currently, the bill requires the Director or Officer of each department to appoint a person to administer the Act under each respective division. However, such appointments are typically made by the Governor. The author may wish to consider whether it may be more appropriate for the Governor to make these appointments. AMENDMENTS: AB 34 Page 56 Local Control and Licensure. The bill specifically states in numerous provisions that any licensing and regulatory structure established under the bill does not affect a local government's ability to enact or enforce local ordinances pursuant to Section 7 of Article XI of the California Constitution. However, there are some places in the bill where this local authority could be further clarified; as a result, the author may wish to consider the following amendments: On page 9, line 20, strike:exclusiveand insert: primary To clarify the type of documentation required to prove that an applicant for state licensure has obtained local permission in accordance with the Act, the author may wish to specify that the documentation shall be issued by the local authority: On page 30, line 11, after "shall" insert: shall be issued by the local authority and AB 34 Page 57 The author may wish to specify that a city or county may impose a temporary local suspension of a licensee not only for a violation of the Act, but also for a local ordinance, and clarify that the ability to impose a temporary local suspension does not limit a local government's authority to take other enforcement action. Section 26066(e): (e) A city, county, or city and county to may impose a temporary local suspension of the license of a commercial licensee for up to 30 days for violations of this chapter or local ordinance . The regulatory authority shall promptly cause an investigation to be made as to whether grounds exist for continued suspension or revocation of the license. If the regulatory authority has not completed its investigation or disciplinary action within 30 days, a city, county, or city and county may impose a subsequent temporary local suspension of the license of a commercial licensee for the same violation until the regulatory authority's investigation, suspension or revocation , and all appeals to that suspension or revocation are complete. This subdivision shall not limit a city, county, or city and county's authority to enforce other laws or ordinances pursuant to the authority granted by Section 7 of Article XI of the California Constitution . . Existing law provides that the immunity that applies to qualified patients and primary caregivers who "collectively or cooperatively" associate to cultivate medical marijuana shall not solely on the basis of that fact be subject to specified criminal sanctions. The bill provides that six months after the AB 34 Page 58 issuance of provisional licenses pursuant to the Act, this immunity shall no longer be available to licensees under the Act, who are specifically provided immunity under Section 26049. To clarify, however, that the existing exemption for collectives and cooperatives also does not extend beyond that time, the author may wish to consider making the following changes: On page 46, line 26, insert: Subject to subdivision (b ), On page 46, line 38, after "act" insert: or to any persons who collectively or cooperatively cultivate marijuana for medical purposes Because California law prohibits any medical marijuana facility from being located closer than 600 feet to a school, the author may wish to consider providing evidence of meeting this requirement as part of the licensure process, to quickly eliminate facilities that are not operating in accordance with existing law. On page 31, line 24, after "location" insert: including, if the proposed facility is a cultivator or a dispensary, that AB 34 Page 59 the proposed facility is located beyond at least a 600-foot radius from a school, This bill seeks to provide some flexibility to a regulatory authority when determining whether a license may be denied by allowing the regulatory authority to place reasonable conditions upon licensure to address any concerns. However, the bill does not prohibit the waiver of a specified condition, Section 26040(b)(6), which deals with security requirements. Upon discussion with the author's office, the reference was intended to refer to Section 26047(e)(10), which prohibits licensure if an applicant has been sanctioned for unlicensed medical cannabis activities or has had a licensed revoked. The author should make the following change: On page 33, line 1, strike:paragraph (6) of subdivision (b) of Section 26040and insert paragraph (10) of subdivision (e) The author may also wish to clarify that the conditions for which a license may be denied also may serve as a reason to suspend or revoke a license. On page 33, line 4, after "renewal" insert: or suspend or AB 34 Page 60 revoke a license . The author may wish to clarify that a regulatory is only required to issue a provisional license if the applicant meets all of the requirements in those provisions. On page 37, line 7, after "shall" insert: if the applicant meets all the requirements in this section, " Department of Consumer Affairs (DCA). The DCA issues licenses in dozens of business and professional categories, including doctors, dentists, contractors, cosmetologists and automotive repair facilities. The DCA includes 41 regulatory entities (25 boards, nine bureaus, four committees, two programs, and one commission). These entities establish minimum qualifications and levels of competency for licensure. The DCA's area of expertise includes professional licensure and regulation, primarily of licensed professionals, and the DCA's oversight is typically over fragmented chunks of licensed professionals, as opposed to entire swaths of industries. While the bill currently requires the DCA to play a role under the new licensure and regulatory structure, particularly with respect to the certification and licensing of testing laboratories, this responsibility is not one that is typically within the DCA's purview. As a result, the author may wish to consider eliminating the DCA from the bill. AB 34 Page 61 On page 9, line 40, strike:the Director of Consumer Affairs, Recordkeeping and Auditing. Under the bill, the DMCRE would be responsible for, among other things, maintaining a registry of all licensees and a record of all medical cannabis commercial activity. The bill also prohibits licensees from interacting with non-licensed entities. To ensure that licensees will be able to easily determine whether they are engaging with a licensed entity in compliance with the Act, the author may wish to specify that licensees are able to obtain such information. On page 13, at the end of line 22, add: The division shall make limited licensee information available to a licensee so that it may verify whether it is engaging in commercial cannabis activities with a properly licensed entity . With regards to auditing requirements, the author may wish to specify that the DMCRE has the discretion to determine the type of annual audit required, instead of requiring the State Auditor to conduct annual audits of all licensees and that licensees are responsible for those audit costs. AB 34 Page 62 On page 35, line 38, strike "by the State Auditor" and insert: as specified by the regulatory authority ," and at the end of line 39, insert: The reasonable costs of the audit shall be paid for by the licensee . Fees and Funds. Currently, the bill has unspecified amounts for various licensure fees and for fees and penalties. The author may wish to consider specifying that any license fee shall be limited to the reasonable regulatory costs incurred by the regulatory entity, and establishing a penalty based on the amount of the fee. On page 14, lines 4-5, strike___dollars ($____) for an initial application, and line 5 ____dollars ($____) for a renewal applicationand insert: the reasonable regulatory costs to the regulatory authority On page 14, lines 13-14, strike:be less line 14 than ____ dollars ($____), nor more than ____ dollars ($____)and insert: exceed the reasonable regulatory costs to the regulatory authority " AB 34 Page 63 On page 36, line 27, strike____ dollars ($____)and insert: the reasonable regulatory costs to the regulatory authority On page 40, line 17, strike:____ dollars ($____)and insert: two times the amount of the license fee In addition, the bill currently requires all fees collected pursuant to the Act to be deposited into the fees account, established within the Medical Cannabis Control Fund, to be appropriated to the DMCRE for costs incurred. Because other regulatory entities will also be collecting fees and incurring costs relating to licensees under their respective jurisdiction, the author may wish to specify that the fees may be appropriated to the appropriate regulatory authority. In addition, the author may wish to clarify in the future each specific fee account that should be created to simplify this process. On page 20, lines 9-10, strike:Division of Medical Cannabis Regulation and Enforcementand insert: appropriate regulatory authority AB 34 Page 64 On page 20, line 12, strike:divisionand insert: regulatory authority Duties of the California Department of Food and Agriculture. To make clear that while the Division of Medical Cannabis Manufacturing and Testing is the one establishing requirements for testing standards, that cultivation licensees under the Division of Medical Cannabis Cultivation are still required to follow those standards, the author may wish to add the following provision: On page 16, line 8, insert: In consultation with the State Department of Public Health, establish testing standards for medical cannabis . The CDFA is organized into six divisions, which include the Inspection Services Division, which inspects crops to ensure that they are safe, abundant, quality food supply and environmentally sound agricultural practices, and the Division of Measurement Standards, which ensure the accuracy of commercial weighing and measuring devices. This bill specifies various duties under the regulatory entities, including requiring the Division of Medical Cannabis Manufacturing and Testing to, among other things, ensure that cultivation licensees have access to agricultural support programs and conform with weighing or measuring standards and standards controlling the application of pesticides. Because these AB 34 Page 65 provisions are typically with the CDFA's jurisdiction, the author should consider reassigning those responsibilities to the Division of Medical Cannabis Cultivation under the CDFA. On page 17, strike lines 35-39, and on page 18, strike lines 1-5 and lines 30-31. On page 16, line 8, insert: (e) Ensure cultivation licensees have access to existing agricultural incentive and support programs. (f) Weighing or measuring standards, including, but not limited to, the requirement that devices used in connection with the sale or distribution of cannabis meet standards equivalent to Division 5 (commencing with Section 12001) of the Business and Professions Code. (g) Standards controlling the application of pesticides. These standards shall, at a minimum, require that if pesticides are to be used, the use comply with standards equivalent to Division 6 (commencing with Section 11401) of the Food and Agricultural Code and its implementing regulations ." AB 34 Page 66 Health, Safety, and Testing Standards. The author may wish to clarify that edible medical cannabis products may be regulated, and do not have to be summarily destroyed as an adulterated product. On page 17, at the end of line 25, insert: For purposes of this chapter, edible medical cannabis products are deemed to be unadulterated food products . In addition, the author may wish to consider specifying that in addition to a testing laboratory having to use methods established by the International Organization for Standardization, specifically ISO/IEC 17025, that laboratories should also use ISO/EIC 17020, which is the visual inspection standard. On page 18, line 29, after "ISO/IEC" insert: 17020 and In addition, in Section 46041(e)(5), the author may wish to AB 34 Page 67 conform testing standards for wholesale licensees with testing standards for other licensees. (5) Require that all medical cannabis and medical cannabis products be tested by a laboratory that has been certified and licensed pursuant to this chapterthe wholesale licenseeprior to commercial exchange with a dispensary. If the licensee has a separate dispensary license, all medical cannabis and medical cannabis products must be tested by a laboratory that has been certified and licensed pursuant to this chapter, prior to retail directly to consumers . Security Standards. Under the bill, dispensaries are required to "maintain dedicated, licensed security staff both inside and outside the dispensary." Because this requirement might be overly burdensome for small dispensaries, which may not pose as great of a risk, the author may wish to consider the following change: On page 19, line 20, strike:both inside and outside the dispensary" and insert: as deemed appropriate by the division The bill currently requires the DMCRE to keep a complete record AB 34 Page 68 of all entities licensed pursuant to the Act, and to make that record available on the DMCRE's website to state and local law enforcement to verify a mandatory commercial license. To address potential security concerns with publishing sensitive information on online, the author may wish to delete the requirement that the information be provided online. On page 41, line 15, strike:on the division's Internet Web site so asand strikepermitLabeling Standards. The bill would require, among other things, that medical cannabis products, including edibles, be labeled and include specified information, such as a list of cannabinoid content and dosage. Because medicinal cannabis varies in terms of the levels and types of active ingredient, for example, and what it is used for varies among patients, it may be difficult to develop a standard "dosage" for products. As a result, the author may wish to consider clarifying labeling standards with regards to medical marijuana products and requiring products to instead state the amount of cannabinoid per milligrams in each serving, and the total amount in a package. The author should also include a warning to let consumers know that the intoxicating effects of edible medical marijuana products may be delayed to prevent consumers from consuming more than is necessary to alleviate symptoms. On page 17, lines 1-2, strike:dosage in total milligrams of AB 34 Page 69 cannabinoids delivered, andand insert on line 2, after "allergens": and the amount in milligrams of cannabinoids per serving, servings per package, and the amount in milligrams of cannabinoids in the total package " REGISTERED SUPPORT: American Nurses Association\California Conscious Cannabis Ventures Emerald Growers Association Heritage Associates United Food and Commercial Workers Union 1 owner of a cannabis dispensary REGISTERED OPPOSITION: Association for Los Angeles Deputy Sheriffs AB 34 Page 70 Association of Deputy District Attorneys California Association of Code Enforcement Officers California Narcotics Officers' Association California Police Chiefs Association California College and University Police Chiefs Association California Correctional Supervisors Organization City of Concord City of Tulare Family Winemakers of California International Faith Based Coalition League of California Cities Los Angeles Police Protective League Riverside Sheriffs Association AB 34 Page 71 Analysis Prepared by:Eunie Linden / B. & P. / (916) 319-3301, Christian Jagusch / B. & P. / (916) 319-3301