AB 2679: Medical marijuana: regulation: research.
- Session Year: 2015-2016
- House: Assembly
- Latest Version Date: 2016-09-29
(1)Existing law, the Medical Marijuana Regulation and Safety Act (MMRSA), provides for the licensure of persons engaged in specified activities relating to medical marijuana and establishes other regulatory provisions. That act also requires each licensing authority to prepare and submit to the Legislature an annual report on the authoritys activities and post the report on the authoritys Internet Web site.
This bill would require the report to also include the number of appeals from the denial of state licenses or other disciplinary actions taken by the licensing authority, the average time spent on these appeals, and the number of complaints submitted by citizens or representatives of cities or counties regarding licensees, as specified.
(2)Existing law authorizes the creation by the University of California of the California Marijuana Research Program, the purpose of which is to develop and conduct studies intended to ascertain the general medical safety and efficacy of marijuana, and if found valuable, to develop medical guidelines for the appropriate administration and use of marijuana.
This bill would specify that the studies may include studies to ascertain the effect of marijuana on motor skills.
(3)Existing law, until one year after the Bureau of Medical Cannabis Regulation posts a notice on its Internet Web site that licensing authorities have commenced issuing licenses pursuant to the MMRSA, exempts cooperatives and collectives who cultivate medical cannabis for qualified patients from criminal sanctions for specified activities related to the growing, sale, and distribution of marijuana.
This bill, during that same period, would exempt collectives and cooperatives that manufacture medical cannabis products from criminal sanctions for manufacturing medical cannabis if the cooperative or collective meets specified requirements, including using specified manufacturing processes and possessing a valid local license, permit, or other authorization.
(1)Existing law, the Medical Marijuana Regulation and Safety Act (MMRSA), provides for the licensure of persons engaged in specified activities relating to medical marijuana and establishes other regulatory provisions. That act also requires each licensing authority to prepare and submit to the Legislature an annual report on the authoritys activities and post the report on the authoritys Internet Web site.
This bill would require the report to also include the number of appeals from the denial of state licenses or other disciplinary actions taken by the licensing authority, the average time spent on these appeals, and the number of complaints submitted by citizens or representatives of cities or counties regarding licensees, as specified.
(2)Existing law authorizes the creation by the University of California of the California Marijuana Research Program, the purpose of which is to develop and conduct studies intended to ascertain the general medical safety and efficacy of marijuana, and if found valuable, to develop medical guidelines for the appropriate administration and use of marijuana.
This bill would specify that the studies may include studies to ascertain the effect of marijuana on motor skills.
(3)Existing law, until one year after the Bureau of Medical Cannabis Regulation posts a notice on its Internet Web site that licensing authorities have commenced issuing licenses pursuant to the MMRSA, exempts cooperatives and collectives who cultivate medical cannabis for qualified patients from criminal sanctions for specified activities related to the growing, sale, and distribution of marijuana.
This bill, during that same period, would exempt collectives and cooperatives that manufacture medical cannabis products from criminal sanctions for manufacturing medical cannabis if the cooperative or collective meets specified requirements, including using specified manufacturing processes and possessing a valid local license, permit, or other authorization.
Existing
(1)Existing law, the Medical Marijuana Regulation and Safety Act, Act (MMRSA), provides for the licensure of persons engaged in specified activities relating to medical marijuana and establishes other regulatory provisions. That act also requires each licensing authority to prepare and submit to the Legislature an annual report on the authoritys activities and post the report on the authoritys Internet Web site.
This bill would require the report to also include the number of appeals from the denial of state licenses or other disciplinary actions taken by the licensing authority, the average time spent on these appeals, and the number of complaints submitted by citizens or representatives of cities or counties regarding licensees, as specified.
Existing
(2)Existing law authorizes the creation by the University of California of the California Marijuana Research Program, the purpose of which is to develop and conduct studies intended to ascertain the general medical safety and efficacy of marijuana, and if found valuable, to develop medical guidelines for the appropriate administration and use of marijuana.
This bill would specify that the studies may include studies to ascertain the effect of marijuana on motor skills.
(3)Existing law, until one year after the Bureau of Medical Cannabis Regulation posts a notice on its Internet Web site that licensing authorities have commenced issuing licenses pursuant to the MMRSA, exempts cooperatives and collectives who cultivate medical cannabis for qualified patients from criminal sanctions for specified activities related to the growing, sale, and distribution of marijuana.
This bill, during that same period, would exempt collectives and cooperatives that manufacture medical cannabis products from criminal sanctions for manufacturing medical cannabis if the cooperative or collective meets specified requirements, including using specified manufacturing processes and possessing a valid local license, permit, or other authorization.
Existing law, the Medical Marijuana Regulation and Safety Act, provides for the licensure of persons engaged in specified activities relating to medical marijuana and establishes other regulatory provisions. That act also requires each licensing authority to prepare and submit to the Legislature an annual report on the authoritys activities and post the report on the authoritys Internet Web site.
This bill would make a nonsubstantive change to that provision. require the report to also include the number of appeals from the denial of state licenses or other disciplinary actions taken by the licensing authority, the average time spent on these appeals, and the number of complaints submitted by citizens or representatives of cities or counties regarding licensees, as specified.
Existing law authorizes the creation by the University of California of the California Marijuana Research Program, the purpose of which is to develop and conduct studies intended to ascertain the general medical safety and efficacy of marijuana, and if found valuable, to develop medical guidelines for the appropriate administration and use of marijuana.
This bill would specify that the studies may include studies to ascertain the effect of marijuana on motor skills.
Existing law, the Medical Marijuana Regulation and Safety Act, provides for the licensure of persons engaged in specified activities relating to medical marijuana and establishes other regulatory provisions. That act also requires each licensing authority to prepare and submit to the Legislature an annual report on the authoritys activities and post the report on the authoritys Internet Web site.
This bill would make a nonsubstantive change to that provision.
Beginning on March 1, 2023, and on or before March 1 of each year thereafter, each licensing authority shall prepare and submit to the Legislature an annual report on the authoritys activities, in compliance with Section 9795 of the Government Code, and post the report on the authoritys Internet Web site. The report shall include, but not be limited to, the following information for the previous fiscal year:
(a)The amount of funds allocated and spent by the licensing authority for medical cannabis licensing, enforcement, and administration.
(b)The number of state licenses issued, renewed, denied, suspended, and revoked, by state license category.
(c)The average time for processing state license applications, by state license category.
(d)The number of appeals from the denial of state licenses or other disciplinary actions taken by the licensing authority and the average time spent on these appeals.
(e)The number of complaints submitted by citizens or representatives of cities or counties regarding licensees, provided as both a comprehensive statewide number and by geographical region.
(f)The number and type of enforcement activities conducted by the licensing authorities and by local law enforcement agencies in conjunction with the licensing authorities or the bureau.
(g)The number, type, and amount of penalties, fines, and other disciplinary actions taken by the licensing authorities.
SEC. 2.Section 11362.775 of the Health and Safety Code is amended to read:11362.775.(a)Subject to subdivision (d), qualified patients, persons with valid identification cards, and the designated primary caregivers of qualified patients and persons with identification cards, who associate within the State of California in order collectively or cooperatively to cultivate cannabis for medical purposes, shall not solely on the basis of that fact be subject to state criminal sanctions under Section 11357, 11358, 11359, 11360, 11366, 11366.5, or 11570.
(b)A collective or cooperative that operates pursuant to this section and manufactures medical cannabis products shall not, solely on the basis of that fact, be subject to state criminal sanctions under Section 11379.6 if the collective or cooperative abides by all of the following requirements:
(1)The collective or cooperative does either or both of the following:
(A)Utilizes only manufacturing processes that are either solventless or that employ only nonflammable, nontoxic solvents that are generally recognized as safe pursuant to the federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 301 et seq.).
(B)Utilizes only manufacturing processes that use solvents exclusively within a closed-loop system that meets all of the following requirements:
(i)The system uses only solvents that are generally recognized as safe pursuant to the federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 301 et seq.).
(ii)The system is designed to recapture and contain solvents during the manufacturing process, and otherwise prevent the off-gassing of solvents into the ambient atmosphere to mitigate the risks of ignition and explosion during the manufacturing process.
(iii)A licensed engineer certifies that the system was commercially manufactured, safe for its intended use, and built to codes of recognized and generally accepted good engineering practices, including, but not limited to, the American Society of Mechanical Engineers (ASME), the American National Standards Institute (ANSI), Underwriters Laboratories (UL), the American Society for Testing and Materials (ASTM), or OSHA Nationally Recognized Testing Laboratories (NRTLs).
(iv)The system has a certification document that contains the signature and stamp of a professional engineer and the serial number of the extraction unit being certified.
(2)The collective or cooperative receives and maintains approval from the local fire official for the closed-loop system, other equipment, the extraction operation, and the facility.
(3)The collective or cooperative meets required fire, safety, and building code requirements in one or more of the following:
(A)The California Fire Code.
(B)The National Fire Protection Association (NFPA) standards.
(C)International Building Code (IBC).
(D)The International Fire Code (IFC).
(E)Other applicable standards, including complying with all applicable fire, safety, and building codes in processing, handling, and storage of solvents or gasses.
(4)The collective or cooperative is in possession of a valid sellers permit issued by the State Board of Equalization.
(5)The collective or cooperative is in possession of a valid local license, permit, or other authorization specific to the manufacturing of medical cannabis products, and in compliance with any additional conditions imposed by the city or county issuing the local license, permit, or other authorization.
(c)For purposes of this section, manufacturing means compounding, converting, producing, deriving, processing, or preparing, either directly or indirectly by chemical extraction or independently by means of chemical synthesis, medical cannabis products.
(d)This section shall remain in effect only until one year after the Bureau of Medical Cannabis Regulation posts a notice on its Internet Web site that the licensing authorities have commenced issuing licenses pursuant to the Medical Cannabis Regulation and Safety Act (Chapter 3.5 (commencing with Section 19300) of Division 8 of the Business and Professions Code).
(e)This section is repealed one year after the date upon which the notice is posted pursuant to subdivision (d).
SEC. 3.Section 11362.9 of the Health and Safety Code is amended to read:11362.9.(a)(1)It is the intent of the Legislature that the state commission objective scientific research by the premier research institute of the world, the University of California, regarding the efficacy and safety of administering marijuana as part of medical treatment. If the Regents of the University of California, by appropriate resolution, accept this responsibility, the University of California shall create a program, to be known as the California Marijuana Research Program.
(2)The program shall develop and conduct studies intended to ascertain the general medical safety and efficacy of marijuana and, if found valuable, shall develop medical guidelines for the appropriate administration and use of marijuana. The studies may include studies to ascertain the effect of marijuana on motor skills.
(b)The program may immediately solicit proposals for research projects to be included in the marijuana studies. Program requirements to be used when evaluating responses to its solicitation for proposals, shall include, but not be limited to, all of the following:
(1)Proposals shall demonstrate the use of key personnel, including clinicians or scientists and support personnel, who are prepared to develop a program of research regarding marijuanas general medical efficacy and safety.
(2)Proposals shall contain procedures for outreach to patients with various medical conditions who may be suitable participants in research on marijuana.
(3)Proposals shall contain provisions for a patient registry.
(4)Proposals shall contain provisions for an information system that is designed to record information about possible study participants, investigators, and clinicians, and deposit and analyze data that accrues as part of clinical trials.
(5)Proposals shall contain protocols suitable for research on marijuana, addressing patients diagnosed with acquired immunodeficiency syndrome (AIDS) or human immunodeficiency virus (HIV), cancer, glaucoma, or seizures or muscle spasms associated with a chronic, debilitating condition. The proposal may also include research on other serious illnesses, provided that resources are available and medical information justifies the research.
(6)Proposals shall demonstrate the use of a specimen laboratory capable of housing plasma, urine, and other specimens necessary to study the concentration of cannabinoids in various tissues, as well as housing specimens for studies of toxic effects of marijuana.
(7)Proposals shall demonstrate the use of a laboratory capable of analyzing marijuana, provided to the program under this section, for purity and cannabinoid content and the capacity to detect contaminants.
(c)In order to ensure objectivity in evaluating proposals, the program shall use a peer review process that is modeled on the process used by the National Institutes of Health, and that guards against funding research that is biased in favor of or against particular outcomes. Peer reviewers shall be selected for their expertise in the scientific substance and methods of the proposed research, and their lack of bias or conflict of interest regarding the applicants or the topic of an approach taken in the proposed research. Peer reviewers shall judge research proposals on several criteria, foremost among which shall be both of the following:
(1)The scientific merit of the research plan, including whether the research design and experimental procedures are potentially biased for or against a particular outcome.
(2)Researchers expertise in the scientific substance and methods of the proposed research, and their lack of bias or conflict of interest regarding the topic of, and the approach taken in, the proposed research.
(d)If the program is administered by the Regents of the University of California, any grant research proposals approved by the program shall also require review and approval by the research advisory panel.
(e)It is the intent of the Legislature that the program be established as follows:
(1)The program shall be located at one or more University of California campuses that have a core of faculty experienced in organizing multidisciplinary scientific endeavors and, in particular, strong experience in clinical trials involving psychopharmacologic agents. The campuses at which research under the auspices of the program is to take place shall accommodate the administrative offices, including the director of the program, as well as a data management unit, and facilities for storage of specimens.
(2)When awarding grants under this section, the program shall utilize principles and parameters of the other well-tested statewide research programs administered by the University of California, modeled after programs administered by the National Institutes of Health, including peer review evaluation of the scientific merit of applications.
(3)The scientific and clinical operations of the program shall occur, partly at University of California campuses, and partly at other postsecondary institutions, that have clinicians or scientists with expertise to conduct the required studies. Criteria for selection of research locations shall include the elements listed in subdivision (b) and, additionally, shall give particular weight to the organizational plan, leadership qualities of the program director, and plans to involve investigators and patient populations from multiple sites.
(4)The funds received by the program shall be allocated to various research studies in accordance with a scientific plan developed by the Scientific Advisory Council. As the first wave of studies is completed, it is anticipated that the program will receive requests for funding of additional studies. These requests shall be reviewed by the Scientific Advisory Council.
(5)The size, scope, and number of studies funded shall be commensurate with the amount of appropriated and available program funding.
(f)All personnel involved in implementing approved proposals shall be authorized as required by Section 11604.
(g)Studies conducted pursuant to this section shall include the greatest amount of new scientific research possible on the medical uses of, and medical hazards associated with, marijuana. The program shall consult with the Research Advisory Panel analogous agencies in other states, and appropriate federal agencies in an attempt to avoid duplicative research and the wasting of research dollars.
(h)The program shall make every effort to recruit qualified patients and qualified physicians from throughout the state.
(i)The marijuana studies shall employ state-of-the-art research methodologies.
(j)The program shall ensure that all marijuana used in the studies is of the appropriate medical quality and shall be obtained from the National Institute on Drug Abuse or any other federal agency designated to supply marijuana for authorized research. If these federal agencies fail to provide a supply of adequate quality and quantity within six months of the effective date of this section, the Attorney General shall provide an adequate supply pursuant to Section 11478.
(k)The program may review, approve, or incorporate studies and research by independent groups presenting scientifically valid protocols for medical research, regardless of whether the areas of study are being researched by the committee.
(l)(1)To enhance understanding of the efficacy and adverse effects of marijuana as a pharmacological agent, the program shall conduct focused controlled clinical trials on the usefulness of marijuana in patients diagnosed with AIDS or HIV, cancer, glaucoma, or seizures or muscle spasms associated with a chronic, debilitating condition. The program may add research on other serious illnesses, provided that resources are available and medical information justifies the research. The studies shall focus on comparisons of both the efficacy and safety of methods of administering the drug to patients, including inhalational, tinctural, and oral, evaluate possible uses of marijuana as a primary or adjunctive treatment, and develop further information on optimal dosage, timing, mode of administration, and variations in the effects of different cannabinoids and varieties of marijuana.
(2)The program shall examine the safety of marijuana in patients with various medical disorders, including marijuanas interaction with other drugs, relative safety of inhalation versus oral forms, and the effects on mental function in medically ill persons.
(3)The program shall be limited to providing for objective scientific research to ascertain the efficacy and safety of marijuana as part of medical treatment, and should not be construed as encouraging or sanctioning the social or recreational use of marijuana.
(m)(1)Subject to paragraph (2), the program shall, prior to any approving proposals, seek to obtain research protocol guidelines from the National Institutes of Health and shall, if the National Institutes of Health issues research protocol guidelines, comply with those guidelines.
(2)If, after a reasonable period of time of not less than six months and not more than a year has elapsed from the date the program seeks to obtain guidelines pursuant to paragraph (1), no guidelines have been approved, the program may proceed using the research protocol guidelines it develops.
(n)In order to maximize the scope and size of the marijuana studies, the program may do any of the following:
(1)Solicit, apply for, and accept funds from foundations, private individuals, and all other funding sources that can be used to expand the scope or timeframe of the marijuana studies that are authorized under this section. The program shall not expend more than 5 percent of its General Fund allocation in efforts to obtain money from outside sources.
(2)Include within the scope of the marijuana studies other marijuana research projects that are independently funded and that meet the requirements set forth in subdivisions (a) to (c), inclusive. In no case shall the program accept any funds that are offered with any conditions other than that the funds be used to study the efficacy and safety of marijuana as part of medical treatment. Any donor shall be advised that funds given for purposes of this section will be used to study both the possible benefits and detriments of marijuana and that he or she will have no control over the use of these funds.
(o)(1)Within six months of the effective date of this section, the program shall report to the Legislature, the Governor, and the Attorney General on the progress of the marijuana studies.
(2)Thereafter, the program shall issue a report to the Legislature every six months detailing the progress of the studies. The interim reports required under this paragraph shall include, but not be limited to, data on all of the following:
(A)The names and number of diseases or conditions under study.
(B)The number of patients enrolled in each study by disease.
(C)Any scientifically valid preliminary findings.
(p)If the Regents of the University of California implement this section, the President of the University of California shall appoint a multidisciplinary Scientific Advisory Council, not to exceed 15 members, to provide policy guidance in the creation and implementation of the program. Members shall be chosen on the basis of scientific expertise. Members of the council shall serve on a voluntary basis, with reimbursement for expenses incurred in the course of their participation. The members shall be reimbursed for travel and other necessary expenses incurred in their performance of the duties of the council.
(q)No more than 10 percent of the total funds appropriated may be used for all aspects of the administration of this section.
(r)This section shall be implemented only to the extent that funding for its purposes is appropriated by the Legislature in the annual Budget Act.
Beginning on March 1, 2023, and on or before March 1 of each year thereafter, each licensing authority shall prepare and submit to the Legislature an annual report on the authoritys activities, in compliance with Section 9795 of the Government Code, and post the report on the authoritys Internet Web site. The report shall include, but not be limited to, the following information for the previous fiscal year:
(a)The amount of funds allocated and spent by the licensing authority for medical cannabis licensing, enforcement, and administration.
(b)The number of state licenses issued, renewed, denied, suspended, and revoked, by state license category.
(c)The average time for processing state license applications, by state license category.
(d)The number of appeals from the denial of state licenses or other disciplinary actions taken by the licensing authority and the average time spent on these appeals.
(e)The number of complaints submitted by citizens or representatives of cities or counties regarding licensees, provided as both a comprehensive statewide number and by geographical region.
(f)The number and type of enforcement activities conducted by the licensing authorities and by local law enforcement agencies in conjunction with the licensing authorities or the bureau.
(g)The number, type, and amount of penalties, fines, and other disciplinary actions taken by the licensing authorities.
SEC. 2.Section 11362.775 of the Health and Safety Code is amended to read:11362.775.(a)Subject to subdivision (d), qualified patients, persons with valid identification cards, and the designated primary caregivers of qualified patients and persons with identification cards, who associate within the State of California in order collectively or cooperatively to cultivate cannabis for medical purposes, shall not solely on the basis of that fact be subject to state criminal sanctions under Section 11357, 11358, 11359, 11360, 11366, 11366.5, or 11570.
(b)A collective or cooperative that operates pursuant to this section and manufactures medical cannabis products shall not, solely on the basis of that fact, be subject to state criminal sanctions under Section 11379.6 if the collective or cooperative abides by all of the following requirements:
(1)The collective or cooperative does either or both of the following:
(A)Utilizes only manufacturing processes that are either solventless or that employ only nonflammable, nontoxic solvents that are generally recognized as safe pursuant to the federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 301 et seq.).
(B)Utilizes only manufacturing processes that use solvents exclusively within a closed-loop system that meets all of the following requirements:
(i)The system uses only solvents that are generally recognized as safe pursuant to the federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 301 et seq.).
(ii)The system is designed to recapture and contain solvents during the manufacturing process, and otherwise prevent the off-gassing of solvents into the ambient atmosphere to mitigate the risks of ignition and explosion during the manufacturing process.
(iii)A licensed engineer certifies that the system was commercially manufactured, safe for its intended use, and built to codes of recognized and generally accepted good engineering practices, including, but not limited to, the American Society of Mechanical Engineers (ASME), the American National Standards Institute (ANSI), Underwriters Laboratories (UL), the American Society for Testing and Materials (ASTM), or OSHA Nationally Recognized Testing Laboratories (NRTLs).
(iv)The system has a certification document that contains the signature and stamp of a professional engineer and the serial number of the extraction unit being certified.
(2)The collective or cooperative receives and maintains approval from the local fire official for the closed-loop system, other equipment, the extraction operation, and the facility.
(3)The collective or cooperative meets required fire, safety, and building code requirements in one or more of the following:
(A)The California Fire Code.
(B)The National Fire Protection Association (NFPA) standards.
(C)International Building Code (IBC).
(D)The International Fire Code (IFC).
(E)Other applicable standards, including complying with all applicable fire, safety, and building codes in processing, handling, and storage of solvents or gasses.
(4)The collective or cooperative is in possession of a valid sellers permit issued by the State Board of Equalization.
(5)The collective or cooperative is in possession of a valid local license, permit, or other authorization specific to the manufacturing of medical cannabis products, and in compliance with any additional conditions imposed by the city or county issuing the local license, permit, or other authorization.
(c)For purposes of this section, manufacturing means compounding, converting, producing, deriving, processing, or preparing, either directly or indirectly by chemical extraction or independently by means of chemical synthesis, medical cannabis products.
(d)This section shall remain in effect only until one year after the Bureau of Medical Cannabis Regulation posts a notice on its Internet Web site that the licensing authorities have commenced issuing licenses pursuant to the Medical Cannabis Regulation and Safety Act (Chapter 3.5 (commencing with Section 19300) of Division 8 of the Business and Professions Code).
(e)This section is repealed one year after the date upon which the notice is posted pursuant to subdivision (d).
SEC. 3.Section 11362.9 of the Health and Safety Code is amended to read:11362.9.(a)(1)It is the intent of the Legislature that the state commission objective scientific research by the premier research institute of the world, the University of California, regarding the efficacy and safety of administering marijuana as part of medical treatment. If the Regents of the University of California, by appropriate resolution, accept this responsibility, the University of California shall create a program, to be known as the California Marijuana Research Program.
(2)The program shall develop and conduct studies intended to ascertain the general medical safety and efficacy of marijuana and, if found valuable, shall develop medical guidelines for the appropriate administration and use of marijuana. The studies may include studies to ascertain the effect of marijuana on motor skills.
(b)The program may immediately solicit proposals for research projects to be included in the marijuana studies. Program requirements to be used when evaluating responses to its solicitation for proposals, shall include, but not be limited to, all of the following:
(1)Proposals shall demonstrate the use of key personnel, including clinicians or scientists and support personnel, who are prepared to develop a program of research regarding marijuanas general medical efficacy and safety.
(2)Proposals shall contain procedures for outreach to patients with various medical conditions who may be suitable participants in research on marijuana.
(3)Proposals shall contain provisions for a patient registry.
(4)Proposals shall contain provisions for an information system that is designed to record information about possible study participants, investigators, and clinicians, and deposit and analyze data that accrues as part of clinical trials.
(5)Proposals shall contain protocols suitable for research on marijuana, addressing patients diagnosed with acquired immunodeficiency syndrome (AIDS) or human immunodeficiency virus (HIV), cancer, glaucoma, or seizures or muscle spasms associated with a chronic, debilitating condition. The proposal may also include research on other serious illnesses, provided that resources are available and medical information justifies the research.
(6)Proposals shall demonstrate the use of a specimen laboratory capable of housing plasma, urine, and other specimens necessary to study the concentration of cannabinoids in various tissues, as well as housing specimens for studies of toxic effects of marijuana.
(7)Proposals shall demonstrate the use of a laboratory capable of analyzing marijuana, provided to the program under this section, for purity and cannabinoid content and the capacity to detect contaminants.
(c)In order to ensure objectivity in evaluating proposals, the program shall use a peer review process that is modeled on the process used by the National Institutes of Health, and that guards against funding research that is biased in favor of or against particular outcomes. Peer reviewers shall be selected for their expertise in the scientific substance and methods of the proposed research, and their lack of bias or conflict of interest regarding the applicants or the topic of an approach taken in the proposed research. Peer reviewers shall judge research proposals on several criteria, foremost among which shall be both of the following:
(1)The scientific merit of the research plan, including whether the research design and experimental procedures are potentially biased for or against a particular outcome.
(2)Researchers expertise in the scientific substance and methods of the proposed research, and their lack of bias or conflict of interest regarding the topic of, and the approach taken in, the proposed research.
(d)If the program is administered by the Regents of the University of California, any grant research proposals approved by the program shall also require review and approval by the research advisory panel.
(e)It is the intent of the Legislature that the program be established as follows:
(1)The program shall be located at one or more University of California campuses that have a core of faculty experienced in organizing multidisciplinary scientific endeavors and, in particular, strong experience in clinical trials involving psychopharmacologic agents. The campuses at which research under the auspices of the program is to take place shall accommodate the administrative offices, including the director of the program, as well as a data management unit, and facilities for storage of specimens.
(2)When awarding grants under this section, the program shall utilize principles and parameters of the other well-tested statewide research programs administered by the University of California, modeled after programs administered by the National Institutes of Health, including peer review evaluation of the scientific merit of applications.
(3)The scientific and clinical operations of the program shall occur, partly at University of California campuses, and partly at other postsecondary institutions, that have clinicians or scientists with expertise to conduct the required studies. Criteria for selection of research locations shall include the elements listed in subdivision (b) and, additionally, shall give particular weight to the organizational plan, leadership qualities of the program director, and plans to involve investigators and patient populations from multiple sites.
(4)The funds received by the program shall be allocated to various research studies in accordance with a scientific plan developed by the Scientific Advisory Council. As the first wave of studies is completed, it is anticipated that the program will receive requests for funding of additional studies. These requests shall be reviewed by the Scientific Advisory Council.
(5)The size, scope, and number of studies funded shall be commensurate with the amount of appropriated and available program funding.
(f)All personnel involved in implementing approved proposals shall be authorized as required by Section 11604.
(g)Studies conducted pursuant to this section shall include the greatest amount of new scientific research possible on the medical uses of, and medical hazards associated with, marijuana. The program shall consult with the Research Advisory Panel analogous agencies in other states, and appropriate federal agencies in an attempt to avoid duplicative research and the wasting of research dollars.
(h)The program shall make every effort to recruit qualified patients and qualified physicians from throughout the state.
(i)The marijuana studies shall employ state-of-the-art research methodologies.
(j)The program shall ensure that all marijuana used in the studies is of the appropriate medical quality and shall be obtained from the National Institute on Drug Abuse or any other federal agency designated to supply marijuana for authorized research. If these federal agencies fail to provide a supply of adequate quality and quantity within six months of the effective date of this section, the Attorney General shall provide an adequate supply pursuant to Section 11478.
(k)The program may review, approve, or incorporate studies and research by independent groups presenting scientifically valid protocols for medical research, regardless of whether the areas of study are being researched by the committee.
(l)(1)To enhance understanding of the efficacy and adverse effects of marijuana as a pharmacological agent, the program shall conduct focused controlled clinical trials on the usefulness of marijuana in patients diagnosed with AIDS or HIV, cancer, glaucoma, or seizures or muscle spasms associated with a chronic, debilitating condition. The program may add research on other serious illnesses, provided that resources are available and medical information justifies the research. The studies shall focus on comparisons of both the efficacy and safety of methods of administering the drug to patients, including inhalational, tinctural, and oral, evaluate possible uses of marijuana as a primary or adjunctive treatment, and develop further information on optimal dosage, timing, mode of administration, and variations in the effects of different cannabinoids and varieties of marijuana.
(2)The program shall examine the safety of marijuana in patients with various medical disorders, including marijuanas interaction with other drugs, relative safety of inhalation versus oral forms, and the effects on mental function in medically ill persons.
(3)The program shall be limited to providing for objective scientific research to ascertain the efficacy and safety of marijuana as part of medical treatment, and should not be construed as encouraging or sanctioning the social or recreational use of marijuana.
(m)(1)Subject to paragraph (2), the program shall, prior to any approving proposals, seek to obtain research protocol guidelines from the National Institutes of Health and shall, if the National Institutes of Health issues research protocol guidelines, comply with those guidelines.
(2)If, after a reasonable period of time of not less than six months and not more than a year has elapsed from the date the program seeks to obtain guidelines pursuant to paragraph (1), no guidelines have been approved, the program may proceed using the research protocol guidelines it develops.
(n)In order to maximize the scope and size of the marijuana studies, the program may do any of the following:
(1)Solicit, apply for, and accept funds from foundations, private individuals, and all other funding sources that can be used to expand the scope or timeframe of the marijuana studies that are authorized under this section. The program shall not expend more than 5 percent of its General Fund allocation in efforts to obtain money from outside sources.
(2)Include within the scope of the marijuana studies other marijuana research projects that are independently funded and that meet the requirements set forth in subdivisions (a) to (c), inclusive. In no case shall the program accept any funds that are offered with any conditions other than that the funds be used to study the efficacy and safety of marijuana as part of medical treatment. Any donor shall be advised that funds given for purposes of this section will be used to study both the possible benefits and detriments of marijuana and that he or she will have no control over the use of these funds.
(o)(1)Within six months of the effective date of this section, the program shall report to the Legislature, the Governor, and the Attorney General on the progress of the marijuana studies.
(2)Thereafter, the program shall issue a report to the Legislature every six months detailing the progress of the studies. The interim reports required under this paragraph shall include, but not be limited to, data on all of the following:
(A)The names and number of diseases or conditions under study.
(B)The number of patients enrolled in each study by disease.
(C)Any scientifically valid preliminary findings.
(p)If the Regents of the University of California implement this section, the President of the University of California shall appoint a multidisciplinary Scientific Advisory Council, not to exceed 15 members, to provide policy guidance in the creation and implementation of the program. Members shall be chosen on the basis of scientific expertise. Members of the council shall serve on a voluntary basis, with reimbursement for expenses incurred in the course of their participation. The members shall be reimbursed for travel and other necessary expenses incurred in their performance of the duties of the council.
(q)No more than 10 percent of the total funds appropriated may be used for all aspects of the administration of this section.
(r)This section shall be implemented only to the extent that funding for its purposes is appropriated by the Legislature in the annual Budget Act.
Beginning on March 1, 2023, and on or before March 1 of each year thereafter, each licensing authority shall prepare and submit to the Legislature an annual report on the authoritys activities, in compliance with Section 9795 of the Government Code, and post the report on the authoritys Internet Web site. The report shall include, but not be limited to, the following information for the previous fiscal year:
(a)The amount of funds allocated and spent by the licensing authority for medical cannabis licensing, enforcement, and administration.
(b)The number of state licenses issued, renewed, denied, suspended, and revoked, by state license category.
(c)The average time for processing state license applications, by state license category.
(d)The number of appeals from the denial of state licenses or other disciplinary actions taken by the licensing authority and the average time spent on these appeals.
(e)The number of complaints submitted by citizens or representatives of cities or counties regarding licensees, provided as both a comprehensive statewide number and by geographical region.
(f)The number and type of enforcement activities conducted by the licensing authorities and by local law enforcement agencies in conjunction with the licensing authorities or the bureau.
(g)The number, type, and amount of penalties, fines, and other disciplinary actions taken by the licensing authorities.
SEC. 2.Section 11362.775 of the Health and Safety Code is amended to read:11362.775.(a)Subject to subdivision (b), (d), qualified patients, persons with valid identification cards, and the designated primary caregivers of qualified patients and persons with identification cards, who associate within the State of California in order collectively or cooperatively to cultivate cannabis for medical purposes, shall not solely on the basis of that fact be subject to state criminal sanctions under Section 11357, 11358, 11359, 11360, 11366, 11366.5, or 11570.
(b)A collective or cooperative that operates pursuant to this section and manufactures medical cannabis products shall not, solely on the basis of that fact, be subject to state criminal sanctions under Section 11379.6 if the collective or cooperative abides by all of the following requirements:
(1)The collective or cooperative does either or both of the following:
(A)Utilizes only manufacturing processes that are either solventless or that employ only nonflammable, nontoxic solvents that are generally recognized as safe pursuant to the federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 301 et seq.).
(B)Utilizes only manufacturing processes that use solvents exclusively within a closed-loop system that meets all of the following requirements:
(i)The system uses only solvents that are generally recognized as safe pursuant to the federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 301 et seq.).
(ii)The system is designed to recapture and contain solvents during the manufacturing process, and otherwise prevent the off-gassing of solvents into the ambient atmosphere to mitigate the risks of ignition and explosion during the manufacturing process.
(iii)A licensed engineer certifies that the system was commercially manufactured, safe for its intended use, and built to codes of recognized and generally accepted good engineering practices, including, but not limited to, the American Society of Mechanical Engineers (ASME), the American National Standards Institute (ANSI), Underwriters Laboratories (UL), the American Society for Testing and Materials (ASTM), or OSHA Nationally Recognized Testing Laboratories (NRTLs).
(iv)The system has a certification document that contains the signature and stamp of a professional engineer and the serial number of the extraction unit being certified.
(2)The collective or cooperative receives and maintains approval from the local fire official for the closed-loop system, other equipment, the extraction operation, and the facility.
(3)The collective or cooperative meets required fire, safety, and building code requirements in one or more of the following:
(A)The California Fire Code.
(B)The National Fire Protection Association (NFPA) standards.
(C)International Building Code (IBC).
(D)The International Fire Code (IFC).
(E)Other applicable standards, including complying with all applicable fire, safety, and building codes in processing, handling, and storage of solvents or gasses.
(4)The collective or cooperative is in possession of a valid sellers permit issued by the State Board of Equalization.
(5)The collective or cooperative is in possession of a valid local license, permit, or other authorization specific to the manufacturing of medical cannabis products, and in compliance with any additional conditions imposed by the city or county issuing the local license, permit, or other authorization.
(c)For purposes of this section, manufacturing means compounding, converting, producing, deriving, processing, or preparing, either directly or indirectly by chemical extraction or independently by means of chemical synthesis, medical cannabis products.
(b)
(d)This section shall remain in effect only until one year after the Bureau of Medical Cannabis Regulation posts a notice on its Internet Web site that the licensing authorities have commenced issuing licenses pursuant to the Medical Cannabis Regulation and Safety Act (Chapter 3.5 (commencing with Section 19300) of Division 8 of the Business and Professions Code).
(c)
(e)This section is repealed one year after the date upon which the notice is posted pursuant to subdivision (b). (d).
SEC. 2.SEC. 3.Section 11362.9 of the Health and Safety Code is amended to read:11362.9.(a)(1)It is the intent of the Legislature that the state commission objective scientific research by the premier research institute of the world, the University of California, regarding the efficacy and safety of administering marijuana as part of medical treatment. If the Regents of the University of California, by appropriate resolution, accept this responsibility, the University of California shall create a program, to be known as the California Marijuana Research Program.
(2)The program shall develop and conduct studies intended to ascertain the general medical safety and efficacy of marijuana and, if found valuable, shall develop medical guidelines for the appropriate administration and use of marijuana. The studies may include studies to ascertain the effect of marijuana on motor skills.
(b)The program may immediately solicit proposals for research projects to be included in the marijuana studies. Program requirements to be used when evaluating responses to its solicitation for proposals, shall include, but not be limited to, all of the following:
(1)Proposals shall demonstrate the use of key personnel, including clinicians or scientists and support personnel, who are prepared to develop a program of research regarding marijuanas general medical efficacy and safety.
(2)Proposals shall contain procedures for outreach to patients with various medical conditions who may be suitable participants in research on marijuana.
(3)Proposals shall contain provisions for a patient registry.
(4)Proposals shall contain provisions for an information system that is designed to record information about possible study participants, investigators, and clinicians, and deposit and analyze data that accrues as part of clinical trials.
(5)Proposals shall contain protocols suitable for research on marijuana, addressing patients diagnosed with the acquired immunodeficiency syndrome (AIDS) or the human immunodeficiency virus (HIV), cancer, glaucoma, or seizures or muscle spasms associated with a chronic, debilitating condition. The proposal may also include research on other serious illnesses, provided that resources are available and medical information justifies the research.
(6)Proposals shall demonstrate the use of a specimen laboratory capable of housing plasma, urine, and other specimens necessary to study the concentration of cannabinoids in various tissues, as well as housing specimens for studies of toxic effects of marijuana.
(7)Proposals shall demonstrate the use of a laboratory capable of analyzing marijuana, provided to the program under this section, for purity and cannabinoid content and the capacity to detect contaminants.
(c)In order to ensure objectivity in evaluating proposals, the program shall use a peer review process that is modeled on the process used by the National Institutes of Health, and that guards against funding research that is biased in favor of or against particular outcomes. Peer reviewers shall be selected for their expertise in the scientific substance and methods of the proposed research, and their lack of bias or conflict of interest regarding the applicants or the topic of an approach taken in the proposed research. Peer reviewers shall judge research proposals on several criteria, foremost among which shall be both of the following:
(1)The scientific merit of the research plan, including whether the research design and experimental procedures are potentially biased for or against a particular outcome.
(2)Researchers expertise in the scientific substance and methods of the proposed research, and their lack of bias or conflict of interest regarding the topic of, and the approach taken in, the proposed research.
(d)If the program is administered by the Regents of the University of California, any grant research proposals approved by the program shall also require review and approval by the research advisory panel.
(e)It is the intent of the Legislature that the program be established as follows:
(1)The program shall be located at one or more University of California campuses that have a core of faculty experienced in organizing multidisciplinary scientific endeavors and, in particular, strong experience in clinical trials involving psychopharmacologic agents. The campuses at which research under the auspices of the program is to take place shall accommodate the administrative offices, including the director of the program, as well as a data management unit, and facilities for storage of specimens.
(2)When awarding grants under this section, the program shall utilize principles and parameters of the other well-tested statewide research programs administered by the University of California, modeled after programs administered by the National Institutes of Health, including peer review evaluation of the scientific merit of applications.
(3)The scientific and clinical operations of the program shall occur, partly at University of California campuses, and partly at other postsecondary institutions, that have clinicians or scientists with expertise to conduct the required studies. Criteria for selection of research locations shall include the elements listed in subdivision (b) and, additionally, shall give particular weight to the organizational plan, leadership qualities of the program director, and plans to involve investigators and patient populations from multiple sites.
(4)The funds received by the program shall be allocated to various research studies in accordance with a scientific plan developed by the Scientific Advisory Council. As the first wave of studies is completed, it is anticipated that the program will receive requests for funding of additional studies. These requests shall be reviewed by the Scientific Advisory Council.
(5)The size, scope, and number of studies funded shall be commensurate with the amount of appropriated and available program funding.
(f)All personnel involved in implementing approved proposals shall be authorized as required by Section 11604.
(g)Studies conducted pursuant to this section shall include the greatest amount of new scientific research possible on the medical uses of, and medical hazards associated with, marijuana. The program shall consult with the Research Advisory Panel analogous agencies in other states, and appropriate federal agencies in an attempt to avoid duplicative research and the wasting of research dollars.
(h)The program shall make every effort to recruit qualified patients and qualified physicians from throughout the state.
(i)The marijuana studies shall employ state-of-the-art research methodologies.
(j)The program shall ensure that all marijuana used in the studies is of the appropriate medical quality and shall be obtained from the National Institute on Drug Abuse or any other federal agency designated to supply marijuana for authorized research. If these federal agencies fail to provide a supply of adequate quality and quantity within six months of the effective date of this section, the Attorney General shall provide an adequate supply pursuant to Section 11478.
(k)The program may review, approve, or incorporate studies and research by independent groups presenting scientifically valid protocols for medical research, regardless of whether the areas of study are being researched by the committee.
(l)(1)To enhance understanding of the efficacy and adverse effects of marijuana as a pharmacological agent, the program shall conduct focused controlled clinical trials on the usefulness of marijuana in patients diagnosed with AIDS or HIV, cancer, glaucoma, or seizures or muscle spasms associated with a chronic, debilitating condition. The program may add research on other serious illnesses, provided that resources are available and medical information justifies the research. The studies shall focus on comparisons of both the efficacy and safety of methods of administering the drug to patients, including inhalational, tinctural, and oral, evaluate possible uses of marijuana as a primary or adjunctive treatment, and develop further information on optimal dosage, timing, mode of administration, and variations in the effects of different cannabinoids and varieties of marijuana.
(2)The program shall examine the safety of marijuana in patients with various medical disorders, including marijuanas interaction with other drugs, relative safety of inhalation versus oral forms, and the effects on mental function in medically ill persons.
(3)The program shall be limited to providing for objective scientific research to ascertain the efficacy and safety of marijuana as part of medical treatment, and should not be construed as encouraging or sanctioning the social or recreational use of marijuana.
(m)(1)Subject to paragraph (2), the program shall, prior to any approving proposals, seek to obtain research protocol guidelines from the National Institutes of Health and shall, if the National Institutes of Health issues research protocol guidelines, comply with those guidelines.
(2)If, after a reasonable period of time of not less than six months and not more than a year has elapsed from the date the program seeks to obtain guidelines pursuant to paragraph (1), no guidelines have been approved, the program may proceed using the research protocol guidelines it develops.
(n)In order to maximize the scope and size of the marijuana studies, the program may do any of the following:
(1)Solicit, apply for, and accept funds from foundations, private individuals, and all other funding sources that can be used to expand the scope or timeframe of the marijuana studies that are authorized under this section. The program shall not expend more than 5 percent of its General Fund allocation in efforts to obtain money from outside sources.
(2)Include within the scope of the marijuana studies other marijuana research projects that are independently funded and that meet the requirements set forth in subdivisions (a) to (c), inclusive. In no case shall the program accept any funds that are offered with any conditions other than that the funds be used to study the efficacy and safety of marijuana as part of medical treatment. Any donor shall be advised that funds given for purposes of this section will be used to study both the possible benefits and detriments of marijuana and that he or she will have no control over the use of these funds.
(o)(1)Within six months of the effective date of this section, the program shall report to the Legislature, the Governor, and the Attorney General on the progress of the marijuana studies.
(2)Thereafter, the program shall issue a report to the Legislature every six months detailing the progress of the studies. The interim reports required under this paragraph shall include, but not be limited to, data on all of the following:
(A)The names and number of diseases or conditions under study.
(B)The number of patients enrolled in each study by disease.
(C)Any scientifically valid preliminary findings.
(p)If the Regents of the University of California implement this section, the President of the University of California shall appoint a multidisciplinary Scientific Advisory Council, not to exceed 15 members, to provide policy guidance in the creation and implementation of the program. Members shall be chosen on the basis of scientific expertise. Members of the council shall serve on a voluntary basis, with reimbursement for expenses incurred in the course of their participation. The members shall be reimbursed for travel and other necessary expenses incurred in their performance of the duties of the council.
(q)No more than 10 percent of the total funds appropriated may be used for all aspects of the administration of this section.
(r)This section shall be implemented only to the extent that funding for its purposes is appropriated by the Legislature in the annual Budget Act.
Beginning on March 1, 2023, and on or before March 1 of each year thereafter, each licensing authority shall prepare and submit to the Legislature an annual report on the authoritys activities activities, in compliance with Section 9795 of the Government Code, and post the report on the authoritys Internet Web site. The report shall include, but not be limited to, the following information for the previous fiscal year:
(a)The amount of funds allocated and spent by the licensing authority for medical cannabis licensing, enforcement, and administration.
(b)The number of state licenses issued, renewed, denied, suspended, and revoked, by state license category.
(c)The average time for processing state license applications, by state license category.
(d)The number of appeals from the denial of state licenses or other disciplinary actions taken by the licensing authority and the average time spent on these appeals.
(e)The number of complaints submitted by citizens or representatives of cities or counties regarding licensees, provided as both a comprehensive statewide number and by geographical region.
(d)
(f)The number and type of enforcement activities conducted by the licensing authorities and by local law enforcement agencies in conjunction with the licensing authorities or the bureau.
(e)
(g)The number, type, and amount of penalties, fines, and other disciplinary actions taken by the licensing authorities.
SEC. 2.Section 11362.9 of the Health and Safety Code is amended to read:11362.9.(a)(1)It is the intent of the Legislature that the state commission objective scientific research by the premier research institute of the world, the University of California, regarding the efficacy and safety of administering marijuana as part of medical treatment. If the Regents of the University of California, by appropriate resolution, accept this responsibility, the University of California shall create a program, to be known as the California Marijuana Research Program.
(2)The program shall develop and conduct studies intended to ascertain the general medical safety and efficacy of marijuana and, if found valuable, shall develop medical guidelines for the appropriate administration and use of marijuana. The studies may include studies to ascertain the effect of marijuana on motor skills.
(b)The program may immediately solicit proposals for research projects to be included in the marijuana studies. Program requirements to be used when evaluating responses to its solicitation for proposals, shall include, but not be limited to, all of the following:
(1)Proposals shall demonstrate the use of key personnel, including clinicians or scientists and support personnel, who are prepared to develop a program of research regarding marijuanas general medical efficacy and safety.
(2)Proposals shall contain procedures for outreach to patients with various medical conditions who may be suitable participants in research on marijuana.
(3)Proposals shall contain provisions for a patient registry.
(4)Proposals shall contain provisions for an information system that is designed to record information about possible study participants, investigators, and clinicians, and deposit and analyze data that accrues as part of clinical trials.
(5)Proposals shall contain protocols suitable for research on marijuana, addressing patients diagnosed with the acquired immunodeficiency syndrome (AIDS) or the human immunodeficiency virus (HIV), cancer, glaucoma, or seizures or muscle spasms associated with a chronic, debilitating condition. The proposal may also include research on other serious illnesses, provided that resources are available and medical information justifies the research.
(6)Proposals shall demonstrate the use of a specimen laboratory capable of housing plasma, urine, and other specimens necessary to study the concentration of cannabinoids in various tissues, as well as housing specimens for studies of toxic effects of marijuana.
(7)Proposals shall demonstrate the use of a laboratory capable of analyzing marijuana, provided to the program under this section, for purity and cannabinoid content and the capacity to detect contaminants.
(c)In order to ensure objectivity in evaluating proposals, the program shall use a peer review process that is modeled on the process used by the National Institutes of Health, and that guards against funding research that is biased in favor of or against particular outcomes. Peer reviewers shall be selected for their expertise in the scientific substance and methods of the proposed research, and their lack of bias or conflict of interest regarding the applicants or the topic of an approach taken in the proposed research. Peer reviewers shall judge research proposals on several criteria, foremost among which shall be both of the following:
(1)The scientific merit of the research plan, including whether the research design and experimental procedures are potentially biased for or against a particular outcome.
(2)Researchers expertise in the scientific substance and methods of the proposed research, and their lack of bias or conflict of interest regarding the topic of, and the approach taken in, the proposed research.
(d)If the program is administered by the Regents of the University of California, any grant research proposals approved by the program shall also require review and approval by the research advisory panel.
(e)It is the intent of the Legislature that the program be established as follows:
(1)The program shall be located at one or more University of California campuses that have a core of faculty experienced in organizing multidisciplinary scientific endeavors and, in particular, strong experience in clinical trials involving psychopharmacologic agents. The campuses at which research under the auspices of the program is to take place shall accommodate the administrative offices, including the director of the program, as well as a data management unit, and facilities for storage of specimens.
(2)When awarding grants under this section, the program shall utilize principles and parameters of the other well-tested statewide research programs administered by the University of California, modeled after programs administered by the National Institutes of Health, including peer review evaluation of the scientific merit of applications.
(3)The scientific and clinical operations of the program shall occur, partly at University of California campuses, and partly at other postsecondary institutions, that have clinicians or scientists with expertise to conduct the required studies. Criteria for selection of research locations shall include the elements listed in subdivision (b) and, additionally, shall give particular weight to the organizational plan, leadership qualities of the program director, and plans to involve investigators and patient populations from multiple sites.
(4)The funds received by the program shall be allocated to various research studies in accordance with a scientific plan developed by the Scientific Advisory Council. As the first wave of studies is completed, it is anticipated that the program will receive requests for funding of additional studies. These requests shall be reviewed by the Scientific Advisory Council.
(5)The size, scope, and number of studies funded shall be commensurate with the amount of appropriated and available program funding.
(f)All personnel involved in implementing approved proposals shall be authorized as required by Section 11604.
(g)Studies conducted pursuant to this section shall include the greatest amount of new scientific research possible on the medical uses of, and medical hazards associated with, marijuana. The program shall consult with the Research Advisory Panel analogous agencies in other states, and appropriate federal agencies in an attempt to avoid duplicative research and the wasting of research dollars.
(h)The program shall make every effort to recruit qualified patients and qualified physicians from throughout the state.
(i)The marijuana studies shall employ state-of-the-art research methodologies.
(j)The program shall ensure that all marijuana used in the studies is of the appropriate medical quality and shall be obtained from the National Institute on Drug Abuse or any other federal agency designated to supply marijuana for authorized research. If these federal agencies fail to provide a supply of adequate quality and quantity within six months of the effective date of this section, the Attorney General shall provide an adequate supply pursuant to Section 11478.
(k)The program may review, approve, or incorporate studies and research by independent groups presenting scientifically valid protocols for medical research, regardless of whether the areas of study are being researched by the committee.
(l)(1)To enhance understanding of the efficacy and adverse effects of marijuana as a pharmacological agent, the program shall conduct focused controlled clinical trials on the usefulness of marijuana in patients diagnosed with AIDS or HIV, cancer, glaucoma, or seizures or muscle spasms associated with a chronic, debilitating condition. The program may add research on other serious illnesses, provided that resources are available and medical information justifies the research. The studies shall focus on comparisons of both the efficacy and safety of methods of administering the drug to patients, including inhalational, tinctural, and oral, evaluate possible uses of marijuana as a primary or adjunctive treatment, and develop further information on optimal dosage, timing, mode of administration, and variations in the effects of different cannabinoids and varieties of marijuana.
(2)The program shall examine the safety of marijuana in patients with various medical disorders, including marijuanas interaction with other drugs, relative safety of inhalation versus oral forms, and the effects on mental function in medically ill persons.
(3)The program shall be limited to providing for objective scientific research to ascertain the efficacy and safety of marijuana as part of medical treatment, and should not be construed as encouraging or sanctioning the social or recreational use of marijuana.
(m)(1)Subject to paragraph (2), the program shall, prior to any approving proposals, seek to obtain research protocol guidelines from the National Institutes of Health and shall, if the National Institutes of Health issues research protocol guidelines, comply with those guidelines.
(2)If, after a reasonable period of time of not less than six months and not more than a year has elapsed from the date the program seeks to obtain guidelines pursuant to paragraph (1), no guidelines have been approved, the program may proceed using the research protocol guidelines it develops.
(n)In order to maximize the scope and size of the marijuana studies, the program may do any of the following:
(1)Solicit, apply for, and accept funds from foundations, private individuals, and all other funding sources that can be used to expand the scope or timeframe of the marijuana studies that are authorized under this section. The program shall not expend more than 5 percent of its General Fund allocation in efforts to obtain money from outside sources.
(2)Include within the scope of the marijuana studies other marijuana research projects that are independently funded and that meet the requirements set forth in subdivisions (a) to (c), inclusive. In no case shall the program accept any funds that are offered with any conditions other than that the funds be used to study the efficacy and safety of marijuana as part of medical treatment. Any donor shall be advised that funds given for purposes of this section will be used to study both the possible benefits and detriments of marijuana and that he or she will have no control over the use of these funds.
(o)(1)Within six months of the effective date of this section, the program shall report to the Legislature, the Governor, and the Attorney General on the progress of the marijuana studies.
(2)Thereafter, the program shall issue a report to the Legislature every six months detailing the progress of the studies. The interim reports required under this paragraph shall include, but not be limited to, data on all of the following:
(A)The names and number of diseases or conditions under study.
(B)The number of patients enrolled in each study by disease.
(C)Any scientifically valid preliminary findings.
(p)If the Regents of the University of California implement this section, the President of the University of California shall appoint a multidisciplinary Scientific Advisory Council, not to exceed 15 members, to provide policy guidance in the creation and implementation of the program. Members shall be chosen on the basis of scientific expertise. Members of the council shall serve on a voluntary basis, with reimbursement for expenses incurred in the course of their participation. The members shall be reimbursed for travel and other necessary expenses incurred in their performance of the duties of the council.
(q)No more than 10 percent of the total funds appropriated may be used for all aspects of the administration of this section.
(r)This section shall be implemented only to the extent that funding for its purposes is appropriated by the Legislature in the annual Budget Act.
Beginning on March 1, 2023, and on or before March 1 of each following year thereafter, each licensing authority shall prepare and submit to the Legislature an annual report on the authoritys activities and post the report on the authoritys Internet Web site. The report shall include, but not be limited to, the following information for the previous fiscal year:
(a)The amount of funds allocated and spent by the licensing authority for medical cannabis licensing, enforcement, and administration.
(b)The number of state licenses issued, renewed, denied, suspended, and revoked, by state license category.
(c)The average time for processing state license applications, by state license category.
(d)The number and type of enforcement activities conducted by the licensing authorities and by local law enforcement agencies in conjunction with the licensing authorities or the bureau.
(e)The number, type, and amount of penalties, fines, and other disciplinary actions taken by the licensing authorities.
|
Date
|
Status
|
|---|---|
| Aug 30, 2016 | In Assembly. Concurrence in Senate amendments pending. |
| Aug 22, 2016 | From committee: Be re-referred to Com. on B., P. & E.D. pursuant to Senate Rule 29.10 (b). Re-referred to Com. on B., P. & E.D. |
| Aug 22, 2016 | From committee: Be re-referred to Com. on B., P. & E.D. pursuant to Senate Rule 29.10(b). (Ayes 5. Noes 0.) Re-referred to Com. on B., P. & E.D. |
| Aug 22, 2016 | From committee: Be re-referred to Com. on RLS. pursuant to Senate Rule 29.10 (b). Re-referred to Com. on RLS. |
| Aug 22, 2016 | From committee: Be re-referred to Com. on RLS. pursuant to Senate Rule 29.10(b). Re-referred to Com. on RLS. |
| Aug 22, 2016 | Read second time. Ordered to third reading. |
| Aug 25, 2016 | From committee: Return to Senate floor for consideration. (Ayes 8. Noes 0.) . |
| Aug 29, 2016 | Read third time. Passed. Ordered to the Assembly. |
| Aug 29, 2016 | Read third time. Passed. Ordered to the Assembly. (Ayes 32. Noes 7. Page 5487.). |
| Aug 19, 2016 | Read third time and amended. Ordered to second reading. |
| Aug 30, 2016 | Joint Rule 62(a), file notice suspended. |
| Aug 30, 2016 | Joint Rule 62(a), file notice suspended. (Page 6474.) |
| Aug 30, 2016 | Re-referred to Com. on HEALTH. pursuant to Assembly Rule 77.2. |
| Aug 31, 2016 | Assembly Rule 63 suspended. |
| Aug 31, 2016 | From committee: That the Senate amendments be concurred in. (Ayes 16. Noes 0.) (August 31). |
| Aug 31, 2016 | Senate amendments concurred in. To Engrossing and Enrolling. |
| Sep 12, 2016 | Enrolled and presented to the Governor at 11:30 a.m. |
| May 5, 2016 | In Senate. Read first time. To Com. on RLS. for assignment. |
| Feb 21, 2016 | From printer. May be heard in committee March 22. |
| Feb 22, 2016 | Read first time. |
| Mar 17, 2016 | Referred to Com. on B. & P. |
| Mar 18, 2016 | From committee chair, with author's amendments: Amend, and re-refer to Com. on B. & P. Read second time and amended. |
| Mar 28, 2016 | Re-referred to Com. on B. & P. |
| Apr 12, 2016 | From committee: Do pass and re-refer to Com. on APPR. (Ayes 15. Noes 0.) (April 12). Re-referred to Com. on APPR. |
| Apr 27, 2016 | From committee: Do pass. To Consent Calendar. (Ayes 19. Noes 0.) (April 27). |
| Apr 28, 2016 | Read second time. Ordered to Consent Calendar. |
| Feb 19, 2016 | Introduced. To print. |
| May 5, 2016 | Read third time. Passed. Ordered to the Senate. |
| May 5, 2016 | Read third time. Passed. Ordered to the Senate. (Ayes 79. Noes 0. Page 4687.) |
| May 12, 2016 | Referred to Com. on B., P. & E.D. |
| Jun 14, 2016 | From committee: Do pass and re-refer to Com. on APPR. (Ayes 8. Noes 0.) (June 13). Re-referred to Com. on APPR. |
| Jun 21, 2016 | In committee: Hearing postponed by committee. |
| Aug 1, 2016 | From committee: Be placed on second reading file pursuant to Senate Rule 28.8. |
| Aug 2, 2016 | Read second time. Ordered to third reading. |
|
Date
|
Description
|
Location
|
Votes
|
|
|---|---|---|---|---|
| Aug 31, 2016 | AB 2679 COOLEY Concurrence in Senate Amendments | Assembly Floor |
Passed |
|
| Aug 31, 2016 | With recommendation: That Senate amendments be concurred in. | Assembly Standing Committee on Health |
Passed |
|
| Aug 29, 2016 | Assembly 3rd Reading AB2679 Cooley By McGuire | Senate Floor |
Passed |
|
| Aug 25, 2016 | That the measure be returned to Senate Floor for consideration. Ordered to third reading. | Senate Standing Committee on Business, Professions and Economic Development |
Passed |
|
| Jun 13, 2016 | Do pass, but first be re-referred to the Committee on [Appropriations] | Senate Standing Committee on Business, Professions and Economic Development |
Passed |
|
| May 5, 2016 | AB 2679 COOLEY Consent Calendar Second Day Regular Session | Assembly Floor |
Passed |
|
| Apr 27, 2016 | Do pass. To Consent Calendar. | Assembly Standing Committee on Appropriations |
Passed |
|
| Apr 12, 2016 | Do pass and be re-referred to the Committee on [Appropriations] | Assembly Standing Committee on Business and Professions |
Passed |
This list shows positions taken on this bill by organizations on the date displayed, which is linked to the original source.
Positions by individuals are not included.
|
Organization
|
Position
|
Date
|
|---|---|---|
| A Therapeutic Alternative | ** Support | Aug 31, 2016 |
| Americans for Safe Access | ** Support | Aug 31, 2016 |
| Cal Heritage | ** Support | Aug 31, 2016 |
| California Cannabis Industry Association | ** Support | Aug 31, 2016 |
| California Cannabis Manufacturing Association | ** Support | Aug 31, 2016 |
| California Growers Association | ** Support | Aug 31, 2016 |
| California NORML | ** Support | Aug 31, 2016 |
| California Police Chiefs Association | ** Support | Aug 31, 2016 |
| California State Association Of Counties | ** Support | Aug 31, 2016 |
| Canacraft | * Support | Aug 25, 2016 |
| City of Cathedral City | ** Support | Aug 31, 2016 |
| City Of Coachella | ** Support | Aug 31, 2016 |
| City Of Oakland | ** Support | Aug 31, 2016 |
| City of Wanut Creek | ** Support | Aug 25, 2016 |
| Clark Neubert LLP | ** Support | Aug 31, 2016 |
| Cultivation Technologies, Inc | * Support | Aug 25, 2016 |
| Dark Heart Nursery | ** Support | Aug 31, 2016 |
| Diagnostic Lab Corporation | ** Support | Aug 31, 2016 |
| Ease Solutions, Inc. | ** Support | Aug 31, 2016 |
| League Of California Cities | ** Support | Aug 31, 2016 |
| Los Angeles Cannabis Task Force | ** Support | Aug 31, 2016 |
| Moxie | ** Support | Aug 31, 2016 |
| Moxie Extracts | ** Support | Aug 25, 2016 |
| Muniservices, LLC | ** Support | Aug 31, 2016 |
| One individual | ** Support | Aug 31, 2016 |
| Platinum Advisors LLC | * Support | Aug 25, 2016 |
| Rural County Representatives of California SCV Electric, Inc. | ** Support | Aug 31, 2016 |
| Scientists and Farmers for Sensible Cannabis Legislation | ** Support | Aug 31, 2016 |
| SCV Electric, Inc. | ** Support | Aug 25, 2016 |
| Southern Humboldt Community Alliance | ** Support | Aug 31, 2016 |
| Surterra Therapeutics | * Support | Aug 25, 2016 |
| Terra Tech | ** Support | Aug 31, 2016 |
| Terra Tech Corp. | ** Support | Aug 25, 2016 |
| The Werc Shop | ** Support | Aug 31, 2016 |
| United Cannabis Business Association | ** Support | Aug 31, 2016 |
| United Food And Commercial Workers Western States Council | ** Support | Aug 31, 2016 |
| Urban Counties of California | ** Support | Aug 31, 2016 |
| Vicente Sederberg LLC | ** Support | Aug 31, 2016 |
| Walnut Creek, City Of | ** Support | Aug 31, 2016 |
| WeedMaps | ** Support | Aug 31, 2016 |
| Wildcat LLC | ** Support | Aug 25, 2016 |
(Without Reference to File)
CONCURRENCE IN SENATE AMENDMENTS
CSA2 Bill Id:AB 2679
Author:(Cooley, et al.)
As Amended Ver:August 19, 2016
Majority vote
ASSEMBLY: | 79-0 | (May 5, 2016) | SENATE: | 32-7 | (August 29, 2016) |
COMMITTEE VOTE: | 16-0 | (August 31, 2016) | RECOMMENDATION: | concur |
Health
Original Committee Reference: B. & P.
SUMMARY: Exempts collectives or cooperatives that manufacture medical cannabis products from certain criminal sanctions, if specific requirements are met; requires agencies with regulatory responsibilities under the Medical Cannabis Regulation and Safety Act (MCRSA) to include additional information in their existing reporting requirements to the Legislature, and, authorizes the University of California (UC) to ascertain the effect of marijuana on motor skills within its existing authority to study the efficacy and safety of administering medical marijuana. Specifically, this bill:
- Prohibits a collective or cooperative that manufactures medical cannabis products, as specified, from being subject to state criminal sanctions, as specified, if the collective or cooperative abides by all of the following requirements:
- The collective or cooperative does either or both of the following:
- Utilizes only manufacturing processes that are either solventless or that employ nonflammable, nontoxic solvents that are generally recognized as safe pursuant to the federal Food, Drug, and Cosmetic Act, as specified.
- Utilizes only manufacturing processes that use solvents exclusively within a closed-loop system that meets all of the following requirements:
- The system uses only solvents that are generally recognized as safe pursuant to the federal Food, Drug, and Cosmetic Act, as specified;
- The system is designed to recapture and contain solvents during the manufacturing process, and otherwise prevent the off-gassing of solvents into the ambient atmosphere to mitigate the risks of ignition and explosion during the manufacturing process;
- A licensed engineer certifies that the system was commercially manufactured, safe for its intended use, and built to codes of recognized and generally accepted good engineering practices, including but not limited to the American Society of Mechanical Engineers; the American National Standards Institute; Underwriters Laboratories; the American Society for Testing and Materials, or Occupational Safety and Health Administration Nationally Recognized Testing Laboratories; and,
- The system has a certification document that contains the signature and stamp of a professional engineer and the serial number of the extraction unit being certified.
- The collective or cooperative receives and maintains approval from the local fire official for the closed-loop system, other equipment, the extraction operation and the facility;
- The collective or cooperative meets required fire, safety, and building code requirements, as specified;
- The collective or cooperative is in possession of a valid seller's permit issued by the Board of Equalization; and,
- The collective or cooperative is in possession of a valid local license, permit or other authorization specific to the manufacturing of medical cannabis products, and in compliance with any additional conditions imposed by the city or county issuing the local license, permit, or other authorization.
- The collective or cooperative does either or both of the following:
- Defines "manufacturing" as the compounding, converting, producing, deriving, processing or preparing, either directly or indirectly by chemical extraction or independently by means of chemical synthesis, medical cannabis products.
- Requires licensing and regulatory entities with jurisdiction over the MCRSA to include in their existing reporting requirements to the Legislature the following: a) the number of appeals from the denial of state licenses or other disciplinary actions taken by the licensing authority, and the average time spent on these appeals; and, b) the number of complaints submitted by citizens or representatives of cities or counties regarding licensees, provided as both a comprehensive statewide number and by geographical region.
- Authorizes the University of California (UC), pursuant to its existing authority to study the efficacy and safety of administering medical marijuana, to include studies to ascertain the effect of marijuana on motor skills.
The Senate amendments exempt collectives or cooperatives that manufacture cannabis by chemical extraction from specified criminal sanctions.
EXISTING LAW:
- Establishes the MCRSA (formerly referred to as the Medical Marijuana Regulation and Safety Act) to regulate medical cannabis in California, including its cultivation, transportation, storage, distribution, and sale, as specified in AB 243 (Wood), Chapter 688, Statutes of 2015; AB 266 (Bonta), Chapter 689, Statutes of 2015; and, SB 643 (McGuire), Chapter 719, Statutes of 2015.
- Establishes within the Department of Consumer Affairs the Bureau of Medical Cannabis Regulation (Bureau) for the licensure and regulation of medical cannabis.
- Requires each licensing authority under MCRSA to prepare and submit to the Legislature an annual report on specified information, including the number of state licensees issued, renewed, suspended or revoked; the number and type of enforcement activities; and, the average time it takes to process state license applications.
- Establishes the Center for Medicinal Cannabis Research within the UC to study the efficacy and safety of administering marijuana as part of a medical treatment.
FISCAL EFFECT: According to the Assembly Appropriations Committee analysis of a previous version of this bill which included the reporting requirements, this bill will have minor costs to the Department of Public Health and the California Department of Food and Agriculture to report specified information (fee-supported special funds). This bill in its current form was not heard in the Senate Appropriations Committee and was placed on second reading file pursuant to Senate Rule 28.8, which indicates this bill has negligible state costs.
COMMENTS: According to the author, the MCRSA was a huge step forward in regulating the medical cannabis industry which has effectively operated in a legal gray area since the Passage of Proposition 215. The MCRSA's passage last year created a robust administrative and regulatory structure at the state and local level over this industry. As the Bureau ramps up licensure programs and puts regulations in place, it is important that local governments have clarification about what types of manufacturing and extraction are allowed. With this bill, we have set new standards for medical cannabis manufacturers to follow and have provided new clarity for local governments when issuing local licenses. Additionally, accountability and oversight is important to ensure that this new Bureau is functioning efficiently and that community input is being effectively considered and tracked.
Health and Safety Code Section 11358 provides that the processing of any part of marijuana, except as provided by law, is a criminal act. SB 420 (Vasconcellos), Chapter 875, Statutes of 2003, exempted from specified criminal sanctions, including criminal sanctions relating to processing, patients with identification cards, and their designated primary caregivers, who associate within the State of California in order collectively or cooperatively to cultivate marijuana for medical purposes. This exemption from criminal sanction however, does not apply to the manufacturing of any controlled substance (including cannabis) by chemical synthesis. According to the authors, the lack of state protections continues to impact manufacturers. For example, in mid-June of this year, a medical cannabis manufacturer who was in compliance with the local ordinance was raided on the suspicion of conducting extraction by chemical synthesis. Additionally, due to the illegal status of medical cannabis manufacturing, local governments have faced difficulty in differentiating between legitimate operators and illegitimate ones, due to a lack of clear standards for conduct.
The authors also cite the decision in People v. Bergen (166 Cal.App.4th 161), as an illustration of the need for this bill. In that case, the defendant manufactured concentrated cannabis (hash oil or honey oil) by using butane to extract the resin containing the psychoactive ingredient tetrahydrocannabinol from marijuana plant material. The court imposed a harsher penalty because of the use of chemicals in producing the concentrated cannabis.
Analysis Prepared by: Rosielyn Pulmano / HEALTH / (916) 319-2097 FN: 0005022
Date of Hearing: August 31, 2016
ASSEMBLY COMMITTEE ON HEALTH
Jim Wood, Chair
ABPCA Bill Id:AB 2679 (
Author:Cooley) – As Amended Ver:August 19, 2016
SUBJECT: Medical marijuana: regulation: research
SUMMARY: Exempts collectives or cooperatives that manufacture medical cannabis products from certain criminal sanctions, if specific requirements are met; requires agencies with regulatory responsibilities under the Medical Cannabis Regulation and Safety Act (MCRSA) to include additional information in their existing reporting requirements to the Legislature, and, authorizes the University of California (UC) to ascertain the effect of marijuana on motor skills within its existing authority to study the efficacy and safety of administering medical marijuana. Specifically, this bill:
- Prohibits a collective or cooperative that manufactures medical cannabis products, as specified, from being subject to state criminal sanctions, as specified, if the collective or cooperative abides by all of the following requirements:
- The collective or cooperative does either or both of the following:
- Utilizes only manufacturing processes that are either solventless or that employ nonflammable, nontoxic solvents that are generally recognized as safe pursuant to the federal Food, Drug, and Cosmetic Act, as specified.
- Utilizes only manufacturing processes that use solvents exclusively within a closed-loop system that meets all of the following requirements:
- The system uses only solvents that are generally recognized as safe pursuant to the federal Food, Drug, and Cosmetic Act, as specified;
- The system is designed to recapture and contain solvents during the manufacturing process, and otherwise prevent the off-gassing of solvents into the ambient atmosphere to mitigate the risks of ignition and explosion during the manufacturing process;
- A licensed engineer certifies that the system was commercially manufactured, safe for its intended use, and built to codes of recognized and generally accepted good engineering practices, including but not limited to the American Society of Mechanical Engineers; the American National Standards Institute; Underwriters Laboratories; the American Society for Testing and Materials, or Occupational Safety and Health Administration Nationally Recognized Testing Laboratories; and,
- The system has a certification document that contains the signature and stamp of a professional engineer and the serial number of the extraction unit being certified.
- The collective or cooperative receives and maintains approval from the local fire official for the closed-loop system, other equipment, the extraction operation and the facility;
- The collective or cooperative meets required fire, safety, and building code requirements, as specified;
- The collective or cooperative is in possession of a valid seller’s permit issued by the Board of Equalization; and,
- The collective or cooperative is in possession of a valid local license, permit or other authorization specific to the manufacturing of medical cannabis products, and in compliance with any additional conditions imposed by the city or county issuing the local license, permit, or other authorization.
- The collective or cooperative does either or both of the following:
- Defines “manufacturing” as the compounding, converting, producing, deriving, processing or preparing, either directly or indirectly by chemical extraction or independently by means of chemical synthesis, medical cannabis products.
- Requires licensing and regulatory entities with jurisdiction over the MCRSA to include in their existing reporting requirements to the Legislature the following: a) the number of appeals from the denial of state licenses or other disciplinary actions taken by the licensing authority, and the average time spent on these appeals; and, b) the number of complaints submitted by citizens or representatives of cities or counties regarding licensees, provided as both a comprehensive statewide number and by geographical region.
- Authorizes the UC, pursuant to its existing authority to study the efficacy and safety of administering medical marijuana, to include studies to ascertain the effect of marijuana on motor skills.
The Senate amendments exempt collectives or cooperatives that manufacture cannabis by chemical extraction from specified criminal sanctions.
EXISTING LAW:
- Requires the California Department of Public Health (DPH) to establish and maintain a program for a statewide identification card system for medical marijuana. Establishes within DPH the Office of Medical Cannabis Safety to license manufacturers of medical cannabis.
- Establishes Proposition 215, also known as the Compassionate Use Act of 1996, which exempts certain patients and their primary caregivers from criminal liability under state law for the possession and cultivation of marijuana.
- Establishes the MCRSA (formerly referred to as the Medical Marijuana Regulation and Safety Act) to regulate medical cannabis in California, including its cultivation, transportation, storage, distribution, and sale, as specified in AB 243 (Wood), Chapter 688, Statutes of 2015; AB 266 (Bonta), Chapter 689, Statutes of 2015; and, SB 643 (McGuire), Chapter 719, Statutes of 2015.
- Establishes within the Department of Consumer Affairs the Bureau of Medical Cannabis Regulation (Bureau) for the licensure and regulation of medical cannabis.
- Requires each licensing authority under MCRSA to prepare and submit to the Legislature an annual report on specified information, including the number of state licensees issued, renewed, suspended or revoked; the number and type of enforcement activities; and, the average time it takes to process state license applications.
- Establishes the Center for Medicinal Cannabis Research within the UC to study the efficacy and safety of administering marijuana as part of a medical treatment.
- Exempts qualified patients, persons with valid identification cards and designated primary caregivers of qualified patients and persons with identification cards, who associate within the State of California in order collectively or cooperatively to cultivate cannabis for medical purposes from specified criminal sanctions. Provides that this exemption is in effect only until one year after the Bureau posts on its Internet Website that licensing authorities have commenced issuing licenses, as specified.
- Provides that any person who manufactures, compounds, converts, produces, derives, processes or prepares, either directly or indirectly by chemical extraction or independently by means of chemical synthesis, any controlled substance specified as a Schedule I through V drugs will be punished by imprisonment for three, five, or seven years, and by a fine not exceeding $50,000, as specified.
FISCAL EFFECT: According to the Assembly Appropriations Committee analysis of a previous version of this bill which included the reporting requirements, this bill will have minor costs to DPH and the California Department of Food and Agriculture to report specified information (fee-supported special funds). This bill in its current form was not heard in the Senate Appropriations Committee and was placed on second reading file pursuant to Senate Rule 28.8, which indicates this bill has negligible state costs.
COMMENTS:
- PURPOSE OF THIS BILL. According to the author, the MCRSA was a huge step forward in regulating the medical cannabis industry which has effectively operated in a legal gray area since the Passage of Proposition 215. The MCRSA’s passage last year created a robust administrative and regulatory structure at the state and local level over this industry. As the Bureau ramps up licensure programs and puts regulations in place, it is important that local governments have clarification about what types of manufacturing and extraction are allowed. With this bill, we have set new standards for medical cannabis manufacturers to follow and have provided new clarity for local governments when issuing local licenses. Additionally, accountability and oversight is important to ensure that this new Bureau is functioning efficiently and that community input is being effectively considered and tracked.
- BACKGROUND. Health & Safety Code Section 11358 provides that the processing of any part of marijuana, except as provided by law, is a criminal act. SB 420 (Vasconcellos), Chapter 875, Statutes of 2003, exempted from specified criminal sanctions, including criminal sanctions relating to processing, patients with identification cards, and their designated primary caregivers, who associate within the State of California in order collectively or cooperatively to cultivate marijuana for medical purposes. This exemption from criminal sanction however, does not apply to the manufacturing of any controlled substance (including cannabis) by chemical synthesis. According to the authors, the lack of state protections continues to impact manufacturers. For example, in mid-June of this year, a medical cannabis manufacturer who was in compliance with the local ordinance was raided on the suspicion of conducting extraction by chemical synthesis. Additionally, due to the illegal status of medical cannabis manufacturing, local governments have faced difficulty in differentiating between legitimate operators and illegitimate ones, due to a lack of clear standards for conduct.
The authors also cite the decision in People v. Bergen (166 Cal.App.4th 161), as an illustration of the need for this bill. In that case, the defendant manufactured concentrated cannabis (hash oil or honey oil) by using butane to extract the resin containing the psychoactive ingredient tetrahydrocannabinol from marijuana plant material. The court imposed a harsher penalty because of the use of chemicals in producing the concentrated cannabis. - POLICY COMMENT. As drafted, this bill does not include a requirement for the collective or cooperative to comply with industry standards or any standard on the proper disposal of waste associated with manufacturing medical cannabis products, nor specify that staff comply with any training standards for the use of manufacturing processes, including the proper handling or storage of solvents or gasses. The authors may wish to clarify their intent on these issues.
- SUPPORT. Supporters such as the Rural County Representatives of California, the Urban Counties of California and the California State Association of Counties state that this bill would provide a criminal defense within the collective model for cannabis manufacturers if these industry actors conform to a variety of manufacturing standards. Counties believe this is necessary to ensure the safety of manufacturing a variety of medical marijuana products that pose danger to communities. The City of Walnut Creek provides that this bill will help prevent devastating incidents such as explosions due to illegal production and operation, and this bill will clamp down on the underground operators. The California Cannabis Industry Association states that this bill will protect the health and safety of medical cannabis patients while providing medical cannabis businesses with transparency into state processes associated with licensing, enforcement, and administration by the various entities governing medical cannabis.
SUPPORT
A Therapeutic Alternative
Americans for Safe Access
Cal Heritage
CalCann Holdings, LLC
California Cannabis Industry Association
California Cannabis Manufacturing Association
California Growers Association
California NORML
California Police Chiefs Association
California State Association of Counties
City of Cathedral City
City of Coachella
City of Oakland
City of Walnut Creek
Clark Neubert LLP
Cultivation Technologies, Inc.
Dark Heart Nursery
Diagnostic Lab Corporation
Ease Solutions, Inc.
League of California Cities
Los Angeles Cannabis Task Force
Moxie
MuniServices
Scientists and Farmers for Sensible Cannabis Legislation
Rural County Representatives of California
SCV Electric, Inc.
Southern Humboldt Community Alliance
Terra Tech
The Werc Shop
United Cannabis Business Association
United Food and Commercial Workers Western States Council
Urban Counties of California
Vicente Sederberg LLC
Weedmaps
Wildcat, LLC
One individual
OPPOSITION
None on file.
Analysis Prepared by: Rosielyn Pulmano / HEALTH / (916) 319-2097
SENATE COMMITTEE ON
BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT
Senator Jerry Hill, Chair
2015 - 2016 Regular
Bill No: Hearing Date: August 25, 2016
Author: | |||
Version: | August 19, 2016 | ||
Urgency: | No | Fiscal: | Yes |
Consultant: | Sarah Huchel | ||
Subject:
SUMMARY:
Requires marijuana licensing authorities to include annual reports about the number of appeals for license denials, disciplinary actions, and complaints. Authorizes the University of California’s California Marijuana Research Program (Program) to develop and conduct studies to ascertain the effect of marijuana on motor skills and creates a safe harbor for collectives and cooperatives using specified manufacturing processes to create medical cannabis products.
NOTE: The Senate floor amendments of 8/19/16 constitute a rewrite and this measure has been referred to this Committee pursuant to Senate Rule 29.10 (b) for consideration. The Committee may, by a vote of the majority, either: (1) hold the bill, or (2) return the bill to the Senate floor for consideration, or (3) re-refer the bill to fiscal committee pursuant to Joint Rule 10.5.
The Senate floor amendments add language to create a safe harbor for collectives and cooperatives using specified manufacturing processes to create medical cannabis products.
Existing law:
- Establishes the Bureau of Medical Marijuana (Bureau) to oversee the licensing and regulation of medical marijuana. (Business and Professions Code (BPC) Section 19300, et seq.)
- Defines “cannabis” to be all parts of the cannabis plant for specified species, whether growing or not; the seeds thereof; the resin, whether crude or purified, extracted from any part of the plant; and every compound, manufacture, salt, derivative, mixture, or preparation of the plant, its seeds, or resin. (BPC § 19300.5 (f))
- Defines a “licensing authority” as the state agency responsible for the issuance, renewal, or reinstatement of the license, or the state agency authorized to take disciplinary action against the license. (BPC § 19300.5 (w))
- Requires each licensing authority to submit annual reports on the authority’s activities to the Legislature beginning on March 1, 2023, and post the reports on the authority’s Web site. Requires the report to include, but not be limited to, the following information for the previous fiscal year:
- The amount of funds allocated and spent by the licensing authority for medical cannabis licensing, enforcement, and administration;
- The number of state licenses issued, renewed, denied, suspended, and revoked, by state license category;
- The average time for processing state license applications, by state license category;
- The number and type of enforcement activities conducted by the licensing authorities and by local law enforcement agencies in conjunction with the licensing authorities or the Bureau; and,
- The number, type, and amount of penalties, fines, and other disciplinary actions taken by the licensing authorities. (BPC § 19353)
- Establishes the Program within the University of California to conduct studies intended to ascertain the general medical safety and efficacy of marijuana and develop medical guidelines for its appropriate administration and use. (Health and Safety Code (HSC) § 11362.9)
- Subjects every person, except as otherwise provided by law, who manufactures, compounds, converts, produces, derives, processes, or prepares, either directly or indirectly by chemical extraction or independently by means of chemical synthesis, any controlled substance to punishment by imprisonment and by a fine.
(HSC § 11379.6)
This bill:
- Requires each licensing authority to include the following additional information in its annual report to the Legislature:
- The number of appeals from the denial of state licenses or other disciplinary actions taken by the licensing authority and the average time spent on these appeals; and,
- The number of complaints submitted by citizens or representatives of cities or counties regarding licensees, provided as both a comprehensive statewide number and by geographical region.
- Authorizes the Program to develop and conduct studies to ascertain the effect of marijuana on motor skills.
- Prohibits a collective or cooperative manufacturing medical cannabis products and operating pursuant to this bill from state criminal sanctions if the collective or cooperative abides by all of the following requirements:
- The collective or cooperative does either or both of the following:
- Utilizes only manufacturing processes that are either solventless or that employ only nonflammable, nontoxic solvents that are generally recognized as safe pursuant to the federal Food, Drug, and Cosmetic Act.
- Utilizes only manufacturing processes that use solvents exclusively within a closed-loop system that meets all of the following requirements:
- The system uses only solvents that are generally recognized as safe pursuant to the federal Food, Drug, and Cosmetic Act.
- The system is designed to recapture and contain solvents during the manufacturing process, and otherwise prevent the off-gassing of solvents into the ambient atmosphere to mitigate the risks of ignition and explosion during the manufacturing process.
- A licensed engineer certifies that the system was commercially manufactured, safe for its intended use, and built to codes of recognized and generally accepted good engineering practices, including, but not limited to, the American Society of Mechanical Engineers, the American National Standards Institute, Underwriters Laboratories, the American Society for Testing and Materials, or Occupational Safety and Health Administration Nationally Recognized Testing Laboratories.
- The system has a certification document that contains the signature and stamp of a professional engineer and the serial number of the extraction unit being certified.
- The collective or cooperative receives and maintains approval from the local fire official for the closed-loop system, other equipment, the extraction operation, and the facility.
- The collective or cooperative meets required fire, safety, and building code requirements in one or more of the following:
- The California Fire Code.
- The National Fire Protection Association standards.
- International Building Code.
- The International Fire Code.
- Other applicable standards, including complying with all applicable fire, safety, and building codes in processing, handling, and storage of solvents or gasses.
- The collective or cooperative is in possession of a valid seller’s permit issued by the State Board of Equalization.
- The collective or cooperative is in possession of a valid local license, permit, or other authorization specific to the manufacturing of medical cannabis products, and in compliance with any additional conditions imposed by the city or county issuing the local license, permit, or other authorization.
- The collective or cooperative does either or both of the following:
- Defines “manufacturing” as compounding, converting, producing, deriving, processing, or preparing, either directly or indirectly by chemical extraction or independently by means of chemical synthesis, medical cannabis products.
- Makes technical changes.
FISCAL EFFECT:
According to the Assembly Appropriations Committee analysis dated April 27, 2016, (prior to the recent amendments), this bill will have minor costs to the California Department of Public Health (CDPH) and the California Department of Food and Agriculture (CDFA) to report specified information (fee-supported special funds).
This measure was not heard in Senate Appropriations Committee and was placed on second reading file pursuant to Senate Rule 28.8.
COMMENTS:
- Purpose. This bill is sponsored by Cultivation Technologies, Inc. According to the Author, “The Medical Cannabis Regulation and Safety Act was a huge step forward in regulating the medical cannabis industry which has effectively operated in a legal gray area since the passage of Prop. 215. The Act’s passage last year created a robust administrative and regulatory structure at the state and local level over this industry. As the Bureau ramps up licensure programs and puts regulations in place, it is important that local governments have clarification about what types of manufacturing and extraction are allowed. With this bill, we have set new standards for medical cannabis manufacturers to follow and have provided new clarity for local governments when issuing local licenses. Additionally, accountability and oversight is important to ensure that this new Bureau is functioning efficiently and that community input is being effectively considered and tracked.”
- California’s Medical Marijuana Regulatory Background. California began regulating medical marijuana with the passage of the Compassionate Use Act in 1996, which exempted patients and their primary caregivers from criminal liability under state law for the possession and cultivation of marijuana. In 2003, the Legislature authorized the formation of medical marijuana cooperatives—nonprofit organizations that cultivate and distribute marijuana for medical uses to their members through dispensaries. Most recently, the Medical Marijuana Regulation and Safety Act (Act) passed in 2015, which consisted of three separate bills enacted together to license and regulate medical marijuana (AB 243 (Wood, Chapter 688, Statues of 2015); AB 266, (Bonta, Chapter 689, Statutes of 2015); and SB 643 (McGuire, Chapter 719, Statutes of 2015)). These bills created a comprehensive state licensing system for the commercial cultivation, manufacture, retail sale, transport, distribution, delivery, and testing of medical cannabis. Medical marijuana cooperatives will be phased out under the Act and replaced by state-licensed businesses.
This bill will require these entities to annually report to the Legislature the number of appeals from the denial of state licenses or other disciplinary actions, the average time spent on these appeals, and the number of complaints submitted by citizens or representatives of cities or counties regarding licensees, provided as both a comprehensive statewide number and by geographical region.
- The Center for Medicinal Cannabis Research. Seeing a need to better understand the medical uses of marijuana, the Program was established in 1999 within the Center for Medicinal Cannabis Research (Center) to determine the efficacy and safety of administering medical marijuana (SB 847, Vasconcellos, Chapter 750, Statutes of 1999). The Center continues to coordinate and support cannabis research, and focusses on marijuana’s potential medicinal benefits for diseases and conditions identified by the National Academy of Sciences, Institute of Medicine Report and by the Workshop on the Medical Utility of Marijuana, National Institutes of Health. The Center reports that it will be assisting in evaluating the effects of cannabis on driving, as requested in AB 266 (Bonta), and on appropriate prescribing practices, pursuant to SB 643 (McGuire).
This bill authorizes the Center to develop and conduct studies to ascertain the effect of marijuana on motor skills.
- Cannabis Product Manufacturing. This bill permits manufacturing processes that either do not use solvents or use only those solvents generally recognized as safe within an approved closed-loop system. Closed-loop extraction are those enclosed systems in which highly pressurized solvent is sprayed on cannabis to extract resin.
Current law establishes criminal penalties for anyone who manufactures compounds, converts, produces, derives, processes, or prepares, either directly or indirectly by chemical extraction or independently by means of chemical synthesis, any controlled substance, including cannabis. This bill provides a means for cannabis collectives or cooperatives to manufacture cannabis products without fear of prosecution if they adhere to the safety standards established in this bill. These standards will be replaced by those established for licensing manufacturing facilities once the Act is in place.
- Arguments in Support. The Los Angeles Cannabis Task Force writes in support, “In 2015, California passed the Medical Cannabis Regulation and Safety Act (MCRSA), the first regulatory framework for medical cannabis in the state’s history. However, until MCRSA licenses are issued in 2018, current medical cannabis manufacturers cannot operate legally, as they were not protected under the old ‘collective’ model.
“Despite the well-known existence of medical cannabis manufacturers, local governments have been stymied in attempting to properly license and regulate them. Local governments have faced difficulty in differentiating between legitimate operators and illegitimate ones, due to a lack of any clear standards for conduct. In these instances, the MCRSA requirement that licenses are first obtained at the local level, before applying for a state license, breaks down.
“The solution to both of these quandaries is AB 2679, which would impose rigorous, professional standards that will only be attainable by the legitimate operators who will be seeking a state license under MCRSA. With this change, we provide a path to licensure for industry, clarity to local governments, and an immediate positive impact on the lives of manufacturers.”
SUPPORT AND OPPOSITION:
Support:
Cultivation Technologies, Inc. (Sponsor)
Americans for Safe Access
CalCann Holdings, LLC
Cal Heritage
California Cannabis Industry Association
California Growers Association
California NORML
California State Association of Counties
City of Cathedral City, California
City of Oakland
City of Wanut Creek
Clark Neubert LLP
Dark Heart Nursery
Diagnostic Lab Corporation
League of California Cities
Los Angeles Cannabis Task Force
Moxie Extracts
MuniServices
Rural County Representatives of California
Scientists and Framers for Sensible Cannabis Legislation
SCV Electric, Inc.
Southern Humboldt Community Alliance
Terra Tech Corp.
A Therapeutic Alternative
UCBA Trade Association
Urban Counties of California
Vicente Sederberg LLC
Weedmaps
The Werc Shop
Wildcat LLC
Opposition:
None on file as of 8/24/16.
-- END --
Office of Senate Floor Analyses (916) 651-1520 Fax: (916) 327-4478 | AB |
THIRD READING
Bill No: AB 2679
:
SENATE BUS., PROF. & ECON. DEV. COMMITTEE: 8-0, 6/13/16
AYES: Hill, Bates, Block, Gaines, Galgiani, Jackson, Mendoza, Wieckowski
NO VOTE RECORDED: Hernandez
SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8
SENATE BUS., PROF. & ECON. DEV. COMMITTEE: 8-0, 8/25/16 (Pursuant to Senate Rule 29.10)
AYES: Hill, Block, Gaines, Galgiani, Hernandez, Jackson, Mendoza, Wieckowski
NO VOTE RECORDED: Bates
ASSEMBLY FLOOR: 79-0, 5/5/16 (Consent) - See last page for vote
SOURCE: Cultivation Technologies, Inc.
DIGEST: This bill requires marijuana licensing authorities to include annual reports about the number of appeals for license denials, disciplinary actions, and complaints. Authorizes the University of California’s California Marijuana Research Program (Program) to develop and conduct studies to ascertain the effect of marijuana on motor skills.
- Establishes the Bureau of Medical Marijuana (Bureau) to oversee the licensing and regulation of medical marijuana. (Business and Professions Code (BPC) Section 19300, et seq.)
- Defines a “licensing authority” as the state agency responsible for the issuance, renewal, or reinstatement of the license, or the state agency authorized to take disciplinary action against the license. (BPC § 19300.5 (w))
- Requires each licensing authority to submit annual reports, as specified, on the authority’s activities to the Legislature beginning on March 1, 2023, and post the reports on the authority’s Web site. (BPC § 19353)
- Establishes the Program within the University of California to conduct studies intended to ascertain the general medical safety and efficacy of marijuana and develop medical guidelines for its appropriate administration and use. (Health and Safety Code § 11362.9)
- Prohibits the manufacturing of any controlled substance, as specified. (Health and Safety Code § 11379.6)
This bill:
- Requires each licensing authority to include the following additional information in its annual report to the Legislature:
- The number of appeals from the denial of state licenses or other disciplinary actions taken by the licensing authority and the average time spent on these appeals; and,
- The number of complaints submitted by citizens or representatives of cities or counties regarding licensees, provided as both a comprehensive statewide number and by geographical region.
- Authorizes the Program to develop and conduct studies to ascertain the effect of marijuana on motor skills.
- Prohibits a collective or cooperative manufacturing medical cannabis products and operating pursuant to this bill from state criminal sanctions if the collective or cooperative abides by all of the following requirements:
- The collective or cooperative does either or both of the following:
- Utilizes only manufacturing processes that are either solventless or that employ only nonflammable, nontoxic solvents that are generally recognized as safe pursuant to the federal Food, Drug, and Cosmetic Act.
- Utilizes only manufacturing processes that use solvents exclusively within a closed-loop system that meets all of the following requirements:
- The system uses only solvents that are generally recognized as safe pursuant to the federal Food, Drug, and Cosmetic Act.
- The system is designed to recapture and contain solvents during the manufacturing process, and otherwise prevent the off-gassing of solvents into the ambient atmosphere to mitigate the risks of ignition and explosion during the manufacturing process.
- A licensed engineer certifies that the system was commercially manufactured, safe for its intended use, and built to codes of recognized and generally accepted good engineering practices, including, but not limited to, the American Society of Mechanical Engineers, the American National Standards Institute, Underwriters Laboratories, the American Society for Testing and Materials, or Occupational Safety and Health Administration Nationally Recognized Testing Laboratories.
- The system has a certification document that contains the signature and stamp of a professional engineer and the serial number of the extraction unit being certified.
- The collective or cooperative receives and maintains approval from the local fire official for the closed-loop system, other equipment, the extraction operation, and the facility.
- The collective or cooperative meets required fire, safety, and building code requirements in one or more of the following:
- The California Fire Code.
- The National Fire Protection Association standards.
- International Building Code.
- The International Fire Code.
- Other applicable standards, including complying with all applicable fire, safety, and building codes in processing, handling, and storage of solvents or gasses.
- The collective or cooperative is in possession of a valid seller’s permit issued by the State Board of Equalization.
- The collective or cooperative is in possession of a valid local license, permit, or other authorization specific to the manufacturing of medical cannabis products, and in compliance with any additional conditions imposed by the city or county issuing the local license, permit, or other authorization.
- The collective or cooperative does either or both of the following:
- Defines “manufacturing” as compounding, converting, producing, deriving, processing, or preparing, either directly or indirectly by chemical extraction or independently by means of chemical synthesis, medical cannabis products.
- Makes technical changes.
Background
California’s Medical Marijuana Regulatory Background. California began regulating medical marijuana with the passage of the Compassionate Use Act in 1996, which exempted patients and their primary caregivers from criminal liability under state law for the possession and cultivation of marijuana. In 2003, the Legislature authorized the formation of medical marijuana cooperatives—nonprofit organizations that cultivate and distribute marijuana for medical uses to their members through dispensaries. Most recently, the Medical Marijuana Regulation and Safety Act (Act) passed in 2015, which consisted of three separate bills enacted together to license and regulate medical marijuana (AB 243 (Wood, Chapter 688, Statues of 2015); AB 266, (Bonta, Chapter 689, Statutes of 2015); and SB 643 (McGuire, Chapter 719, Statutes of 2015)). These bills created a comprehensive state licensing system for the commercial cultivation, manufacture, retail sale, transport, distribution, delivery, and testing of medical cannabis. Medical marijuana cooperatives will be phased out under the Act and replaced by state-licensed businesses.
This bill will require these entities to annually report to the Legislature the number of appeals from the denial of state licenses or other disciplinary actions, the average time spent on these appeals, and the number of complaints submitted by citizens or representatives of cities or counties regarding licensees, provided as both a comprehensive statewide number and by geographical region.
The Center for Medicinal Cannabis Research. Seeing a need to better understand the medical uses of marijuana, the Program was established in 1999 within the Center for Medicinal Cannabis Research (Center) to determine the efficacy and safety of administering medical marijuana (SB 847, Vasconcellos, Chapter 750, Statutes of 1999). The Center continues to coordinate and support cannabis research, and focusses on marijuana’s potential medicinal benefits for diseases and conditions identified by the National Academy of Sciences, Institute of Medicine Report and by the Workshop on the Medical Utility of Marijuana, National Institutes of Health. The Center reports that it will be assisting in evaluating the effects of cannabis on driving, as requested in AB 266 (Bonta), and on appropriate prescribing practices, pursuant to SB 643 (McGuire).
This bill authorizes the Center to develop and conduct studies to ascertain the effect of marijuana on motor skills.
Cannabis product manufacturing. Current law establishes criminal penalties for anyone who manufactures compounds, converts, produces, derives, processes, or prepares, either directly or indirectly by chemical extraction or independently by means of chemical synthesis, any controlled substance, including cannabis. This bill provides a means for cannabis collectives or cooperatives to manufacture cannabis products without fear of prosecution if they adhere to the safety standards established in this bill.
FISCAL EFFECT: Appropriation: Fiscal Com.: Local:
Cultivation Technologies, Inc. (source)
California Cannabis Industry Association
California Growers Association
California NORML
City of Oakland
City of Wanut Creek
League of California Cities
Los Angeles Cannabis Task Force
Moxie Extracts
MuniServices
The Werc Shop
OPPOSITION: (Verified 8/22/16)
None received
ARGUMENTS IN SUPPORT: The Los Angeles Cannabis Task Force writes in support, “In 2015, California passed the Medical Cannabis Regulation and Safety Act (MCRSA), the first regulatory framework for medical cannabis in the state’s history. However, until MCRSA licenses are issued in 2018, current medical
cannabis manufacturers cannot operate legally, as they were not protected under the old ‘collective’ model.
“Despite the well-known existence of medical cannabis manufacturers, local governments have been stymied in attempting to properly license and regulate them. Local governments have faced difficulty in differentiating between legitimate operators and illegitimate ones, due to a lack of any clear standards for conduct. In these instances, the MCRSA requirement that licenses are first obtained at the local level, before applying for a state license, breaks down.
“The solution to both of these quandaries is AB 2679, which would impose rigorous, professional standards that will only be attainable by the legitimate operators who will be seeking a state license under MCRSA. With this change,
we provide a path to licensure for industry, clarity to local governments, and an immediate positive impact on the lives of manufacturers.”
ASSEMBLY FLOOR: 79-0, 5/5/16
AYES: Achadjian, Alejo, Travis Allen, Arambula, Atkins, Baker, Bigelow, Bloom, Bonilla, Bonta, Brough, Brown, Burke, Calderon, Campos, Chang, Chau, Chávez, Chiu, Chu, Cooley, Cooper, Dababneh, Dahle, Daly, Dodd, Eggman, Frazier, Gallagher, Cristina Garcia, Eduardo Garcia, Gatto, Gipson, Gomez, Gonzalez, Gordon, Gray, Grove, Hadley, Harper, Roger Hernández, Holden, Irwin, Jones, Jones-Sawyer, Kim, Lackey, Levine, Linder, Lopez, Low, Maienschein, Mathis, Mayes, McCarty, Medina, Melendez, Mullin, Nazarian, Obernolte, O'Donnell, Olsen, Patterson, Quirk, Ridley-Thomas, Rodriguez, Salas, Santiago, Steinorth, Mark Stone, Thurmond, Ting, Wagner, Waldron, Weber, Wilk, Williams, Wood, Rendon
NO VOTE RECORDED: Beth Gaines
8/25/16 17:23:54
**** END ****
Office of Senate Floor Analyses (916) 651-1520 Fax: (916) 327-4478 | AB |
THIRD READING
Bill No: AB 2679
:
SENATE BUS., PROF. & ECON. DEV. COMMITTEE: 8-0, 6/13/16
AYES: Hill, Bates, Block, Gaines, Galgiani, Jackson, Mendoza, Wieckowski
NO VOTE RECORDED: Hernandez
SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8
ASSEMBLY FLOOR: 79-0, 5/5/16 (Consent) - See last page for vote
DIGEST: This bill requires marijuana licensing authorities to include annual reports about the number of appeals for license denials, disciplinary actions, and complaints. Authorizes the University of California’s California Marijuana Research Program (Program) to develop and conduct studies to ascertain the effect of marijuana on motor skills.
Existing law:
- Establishes the Bureau of Medical Marijuana (Bureau) to oversee the licensing and regulation of medical marijuana. (Business and Professions Code (BPC) Section 19300, et seq.)
- Defines “cannabis” to be all parts of the cannabis plant for specified species, whether growing or not; the seeds thereof; the resin, whether crude or purified, extracted from any part of the plant; and every compound, manufacture, salt, derivative, mixture, or preparation of the plant, its seeds, or resin. (BPC § 19300.5 (f))
- Defines a “licensing authority” as the state agency responsible for the issuance, renewal, or reinstatement of the license, or the state agency authorized to take disciplinary action against the license. (BPC § 19300.5 (w))
- Requires each licensing authority to submit annual reports on the authority’s activities to the Legislature beginning on March 1, 2023, and post the reports on the authority’s Web site. Requires the report to include, but not be limited to, the following information for the previous fiscal year:
- The amount of funds allocated and spent by the licensing authority for medical cannabis licensing, enforcement, and administration;
- The number of state licenses issued, renewed, denied, suspended, and revoked, by state license category;
- The average time for processing state license applications, by state license category;
- The number and type of enforcement activities conducted by the licensing authorities and by local law enforcement agencies in conjunction with the licensing authorities or the Bureau; and,
- The number, type, and amount of penalties, fines, and other disciplinary actions taken by the licensing authorities. (BPC § 19353)
- Establishes the Program within the University of California to conduct studies intended to ascertain the general medical safety and efficacy of marijuana and develop medical guidelines for its appropriate administration and use. (Health and Safety Code § 11362.9)
This bill:
- Requires each licensing authority to include the following additional information in its annual report to the Legislature:
- The number of appeals from the denial of state licenses or other disciplinary actions taken by the licensing authority and the average time spent on these appeals; and,
- The number of complaints submitted by citizens or representatives of cities or counties regarding licensees, provided as both a comprehensive statewide number and by geographical region.
- Authorizes the Program to develop and conduct studies to ascertain the effect of marijuana on motor skills.
- Makes technical changes.
Background
California’s Medical Marijuana Regulatory Background. California began regulating medical marijuana with the passage of the Compassionate Use Act in 1996, which exempted patients and their primary caregivers from criminal liability under state law for the possession and cultivation of marijuana. In 2003, the Legislature authorized the formation of medical marijuana cooperatives—nonprofit organizations that cultivate and distribute marijuana for medical uses to their members through dispensaries. Most recently, the Medical Marijuana Regulation and Safety Act (Act) passed in 2015, which consisted of three separate bills enacted together to license and regulate medical marijuana (AB 243 (Wood, Chapter 688, Statues of 2015); AB 266, (Bonta, Chapter 689, Statutes of 2015); and SB 643 (McGuire, Chapter 719, Statutes of 2015)). These bills created a comprehensive state licensing system for the commercial cultivation, manufacture, retail sale, transport, distribution, delivery, and testing of medical cannabis. Medical marijuana cooperatives will be phased out under the Act and replaced by state-licensed businesses.
The Act went into effect on January 1, 2016, and licensure requirements will follow when the regulatory entities responsible for implementation pass necessary regulations.
The Act distributes state responsibilities among six agencies:
- The Bureau: responsible for licensing and regulating dispensaries, transporters, and distributors.
- Department of Fish and Wildlife: monitor and reduce environmental impacts of marijuana cultivation.
- State Water Resources Control Board: regulate the environmental impacts of marijuana cultivation on water quality and instream flows.
- California Department of Food and Agriculture: regulate medical marijuana cultivation and issue licenses to growers.
- Department of Public Health: develop and enforce regulations and standards for medical marijuana product manufacturers and testing laboratories.
- Department of Pesticide Regulation: develop pesticide use guidelines for the cultivation of medical marijuana.
This bill will require these entities to annually report to the Legislature the number of appeals from the denial of state licenses or other disciplinary actions, the average time spent on these appeals, and the number of complaints submitted by citizens or representatives of cities or counties regarding licensees, provided as both a comprehensive statewide number and by geographical region.
The Center for Medicinal Cannabis Research. Seeing a need to better understand the medical uses of marijuana, the Program was established in 1999 within the Center for Medicinal Cannabis Research (Center) to determine the efficacy and safety of administering medical marijuana (SB 847, Vasconcellos, Chapter 750, Statutes of 1999). The Center continues to coordinate and support cannabis research, and focusses on marijuana’s potential medicinal benefits for diseases and conditions identified by the National Academy of Sciences, Institute of Medicine Report and by the Workshop on the Medical Utility of Marijuana, National Institutes of Health. The Center reports that it will be assisting in evaluating the effects of cannabis on driving, as requested in AB 266 (Bonta), and on appropriate prescribing practices, pursuant to SB 643 (McGuire).
This bill authorizes the Center to develop and conduct studies to ascertain the effect of marijuana on motor skills.
FISCAL EFFECT: Appropriation: Fiscal Com.: Local:
None received
None received
ASSEMBLY FLOOR: 79-0, 5/5/16
AYES: Achadjian, Alejo, Travis Allen, Arambula, Atkins, Baker, Bigelow, Bloom, Bonilla, Bonta, Brough, Brown, Burke, Calderon, Campos, Chang, Chau, Chávez, Chiu, Chu, Cooley, Cooper, Dababneh, Dahle, Daly, Dodd, Eggman, Frazier, Gallagher, Cristina Garcia, Eduardo Garcia, Gatto, Gipson, Gomez, Gonzalez, Gordon, Gray, Grove, Hadley, Harper, Roger Hernández, Holden, Irwin, Jones, Jones-Sawyer, Kim, Lackey, Levine, Linder, Lopez, Low, Maienschein, Mathis, Mayes, McCarty, Medina, Melendez, Mullin, Nazarian, Obernolte, O'Donnell, Olsen, Patterson, Quirk, Ridley-Thomas, Rodriguez, Salas, Santiago, Steinorth, Mark Stone, Thurmond, Ting, Wagner, Waldron, Weber, Wilk, Williams, Wood, Rendon
NO VOTE RECORDED: Beth Gaines
8/3/16 18:17:27
**** END ****
Date of Hearing: April 27, 2016
ASSEMBLY COMMITTEE ON APPROPRIATIONS
Lorena Gonzalez, Chair
ABPCA Bill Id:AB 2679
Author:(Cooley) – As Amended Ver:March 18, 2016
Policy Committee: | Business and Professions | Vote: | 15 - 0 |
|
|
Urgency: No State Mandated Local Program: No Reimbursable: No
SUMMARY:
This bill requires licensing authorities to report to the Bureau of Medical Marijuana Regulation (Bureau) specified data related to disciplinary actions and complaints, and authorizes the California Marijuana Research Program within the University of California (UC) to conduct studies to ascertain the effect of marijuana (cannabis) on a person’s motor skills.
FISCAL EFFECT:
Minor costs to the California Department of Public Health (CDPH) and the California Department of Food and Agriculture (CDFA) to report specified information (fee-supported special funds).
COMMENTS:
- Purpose. The author states as California ramps up its licensing program, proper accountability and oversight are important to ensure state agencies are functioning efficiently and that community input is being effectively considered and tracked. This bill increases the reporting requirements to enhance transparency. Additionally, this bill includes a conforming change that updates the statutory mission of the CMRP to align with a provision existing law that tasks the program to study the impact cannabis has on motor skills.
- Background. The Medical Marijuana Regulation and Safety Act (Act) consisted of three separate bills which were enacted together on Sept 11, 2015, to bring licensure and regulation to the medical cannabis industry nearly 20 years after the passage of Proposition 215 in 1996, which legalized the use of medical cannabis. The bills created a comprehensive state licensing system for medical cannabis. The Act went into effect on January 1, 2016, although licensure requirements will not go into effect until the regulatory entities responsible for implementing the act pass necessary regulations. The Act establishes the new Bureau under the Department of Consumer Affairs, which is responsible for licensing and regulating dispensaries, transporters, and distributors. CDPH is responsible for licensing manufacturers and testing laboratories, and CDFA is responsible for licensing cultivators. The Act also required the Bureau to contract with the CMRP, an existing research program housed at UC San Diego (now called the Center for Medical Cannabis Research (Center)), to study motor skills impairment. Pursuant to the Act, the Center is currently developing a field test for cannabis intoxication.
Analysis Prepared by: Lisa Murawski / APPR. / (916) 319-2081
SENATE COMMITTEE ON
BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT
Senator Jerry Hill, Chair
2015 - 2016 Regular
Bill No: AB 2679 Hearing Date: June 13, 2016
Author: | Cooley | ||
Version: |
| ||
Urgency: | Fiscal: | ||
Consultant: | |||
Subject: Medical marijuana: regulation: research
SUMMARY:
Requires marijuana licensing authorities to include annual reports about the number of appeals for license denials, disciplinary actions, and complaints. Authorizes the University of California’s California Marijuana Research Program (Program) to develop and conduct studies to ascertain the effect of marijuana on motor skills.
Existing law:
- Establishes the Bureau of Medical Marijuana (Bureau) to oversee the licensing and regulation of medical marijuana. (Business and Professions Code (BPC) Section 19300, et seq.)
- Defines “cannabis” to be all parts of the cannabis plant for specified species, whether growing or not; the seeds thereof; the resin, whether crude or purified, extracted from any part of the plant; and every compound, manufacture, salt, derivative, mixture, or preparation of the plant, its seeds, or resin. (BPC § 19300.5 (f))
- Defines a “licensing authority” as the state agency responsible for the issuance, renewal, or reinstatement of the license, or the state agency authorized to take disciplinary action against the license. (BPC § 19300.5 (w))
- Requires each licensing authority to submit annual reports on the authority’s activities to the Legislature beginning on March 1, 2023, and post the reports on the authority’s Web site. Requires the report to include, but not be limited to, the following information for the previous fiscal year:
- The amount of funds allocated and spent by the licensing authority for medical cannabis licensing, enforcement, and administration;
- The number of state licenses issued, renewed, denied, suspended, and revoked, by state license category;
- The average time for processing state license applications, by state license category;
- The number and type of enforcement activities conducted by the licensing authorities and by local law enforcement agencies in conjunction with the licensing authorities or the Bureau; and,
- The number, type, and amount of penalties, fines, and other disciplinary actions taken by the licensing authorities. (BPC § 19353)
- Establishes the California Marijuana Research Program (Program) within the University of California to conduct studies intended to ascertain the general medical safety and efficacy of marijuana and develop medical guidelines for its appropriate administration and use. (Health and Safety Code § 11362.9)
This bill:
- Requires each licensing authority to include the following additional information in its annual report to the Legislature:
- The number of appeals from the denial of state licenses or other disciplinary actions taken by the licensing authority and the average time spent on these appeals; and,
- The number of complaints submitted by citizens or representatives of cities or counties regarding licensees, provided as both a comprehensive statewide number and by geographical region.
- Authorizes the Program to develop and conduct studies to ascertain the effect of marijuana on motor skills.
- Makes technical changes.
FISCAL EFFECT:
This bill is keyed “fiscal” by Legislative Counsel. This measure met the threshold for the Assembly Appropriations Committee’s consent file.
COMMENTS:
- Purpose. This bill is Author sponsored. According to the Author’s office, “As we review AB 266 (Bonta, Cooley, Lackey, Jones-Sawyer and Wood) from last year, it is important that we make sure the language has strong directives for oversight. One area that we are seeking to improve with this bill is the reporting requirements on the denial of licenses, disciplinary actions taken by the Bureau, and citizen complaints lodged against licensees to make sure that the agency is working effectively and community voices are being heard.”
- California’s Medical Marijuana Regulatory Background. California began regulating medical marijuana with the passage of the Compassionate Use Act in 1996, which exempted patients and their primary caregivers from criminal liability under state law for the possession and cultivation of marijuana. In 2003, the Legislature authorized the formation of medical marijuana cooperatives—nonprofit organizations that cultivate and distribute marijuana for medical uses to their members through dispensaries. Most recently, the Medical Marijuana Regulation and Safety Act (Act) passed in 2015, which consisted of three separate bills enacted together to license and regulate medical marijuana (AB 243 (Wood, Chapter 688, Statues of 2015); AB 266, (Bonta, Chapter 689, Statutes of 2015); and SB 643 (McGuire, Chapter 719, Statutes of 2015). These bills created a comprehensive state licensing system for the commercial cultivation, manufacture, retail sale, transport, distribution, delivery, and testing of medical cannabis. Medical marijuana cooperatives will be phased out under the Act and replaced by state-licensed businesses.
The Act went into effect on January 1, 2016, and licensure requirements will follow when the regulatory entities responsible for implementation pass necessary regulations.
The Act distributes state responsibilities among six agencies:
- The Bureau: responsible for licensing and regulating dispensaries, transporters, and distributors.
- Department of Fish and Wildlife (DFW): monitor and reduce environmental impacts of marijuana cultivation.
- State Water Resources Control Board (SWRCB): regulate the environmental impacts of marijuana cultivation on water quality and instream flows.
- California Department of Food and Agriculture (CDFA): regulate medical marijuana cultivation and issue licenses to growers.
- Department of Public Health (DPH): develop and enforce regulations and standards for medical marijuana product manufacturers and testing laboratories.
- Department of Pesticide Regulation (DPR): develop pesticide use guidelines for the cultivation of medical marijuana.
This bill will require these entities to annually report to the Legislature the number of appeals from the denial of state licenses or other disciplinary actions, the average time spent on these appeals, and the number of complaints submitted by citizens or representatives of cities or counties regarding licensees, provided as both a comprehensive statewide number and by geographical region.
- The Center for Medicinal Cannabis Research. Seeing a need to better understand the medical uses of marijuana, the Program was established in 1999 within the Center for Medicinal Cannabis Research (Center) to determine the efficacy and safety of administering medical marijuana (SB 847, Chapter 750, Statutes of 1999). The Center continues to coordinate and support cannabis research, and focusses on marijuana’s potential medicinal benefits for diseases and conditions identified by the National Academy of Sciences, Institute of Medicine Report and by the Workshop on the Medical Utility of Marijuana, National Institutes of Health. The Center reports that it will be assisting in evaluating the effects of cannabis on driving, as requested in AB 266 (Bonta) Chapter 689, Statutes of 2015, and on appropriate prescribing practices, pursuant to SB 643 (McGuire) Chapter 719, Statutes of 2015.
This bill authorizes the Center to develop and conduct studies to ascertain the effect of marijuana on motor skills.
- Related Legislation. AB 26 (Jones-Sawyer) of 2015 requires a licensee under the Act to institute and maintain a training program to educate, inform, and train the licensee's agents and employees regarding compliance with the Act, and requires the Bureau to approve and regulate the training programs. (Status: This bill is pending in the Senate Committee on Business, Professions and Economic Development.)
AB 567 (Gipson) of 2015 establishes a tax amnesty program for medical cannabis related businesses and prohibits regulatory entities from issuing, reinstating, or renewing a license or permit for a qualified taxpayer that is eligible to participate in the program but does not. (Status: This bill is pending in the Senate Committee on Business, Professions and Economic Development.)
AB 1575 (Bonta) of 2015 updates the Act with numerous provisions related to medical cannabis licensure and regulation: (Status: This bill is pending in the Senate Rules Committee.)
AB 2385 (Jones-Sawyer) of 2015 prohibits licensing authorities from requiring a local license, permit, or other authorization, and would require the issuance of state license if the authorities determine that the applicant meets all the requirements of the Act and specified criteria relating to Measure D, which was approved by the voters of the City of Los Angeles. (Status: This bill is pending in the Senate Committee on Business, Professions and Economic Development.)
- Previous Legislation. AB 266 (Bonta, Cooley, Jones-Sawyer, Lackey, and Wood), Chapter 689, Statutes of 2015, enacted the Act for the licensure and regulation of medical marijuana, established the Bureau within the DCA, required the CDFA to administer the provisions of the act related to cultivation, required the CDPH to administer the provisions of the Act related to manufacturing and testing of medical cannabis, required the Board of Equalization to adopt a system for reporting the movement of commercial cannabis and cannabis products.
AB 243 (Wood, Chapter 688, Statutes of 2015) required the CDFA, the DPR, the CDPH, the DFW, and the SWRCB to promulgate regulations relating to medical marijuana and its cultivation, as specified, required various state agencies to take specified actions to mitigate the impact that marijuana cultivation has on the environment, and established the Act Fund.
SB 643 (McGuire, Chapter 719, Statutes of 2015) established standards for the prescription of medical cannabis, required the Medical Board of California to prioritize its investigative and prosecutorial resources to identify and discipline physicians and surgeons that have repeatedly recommended excessive cannabis to patients for medical purposes or repeatedly recommended cannabis to patients for medical purposes without a good faith examination, as specified, authorized counties to impose a tax upon specified cannabis-related activity, and set forth standards for the licensed cultivation of medical cannabis.
SB 295 (Vasconcellos, Chapter 704, Statutes of 2003) eliminated the three-year time limit on the Program.
SB 847 (Vasconcellos, Chapter 750, Statutes of 1999) established a three-year research program to determine the safety and efficacy of marijuana as a therapeutic drug.
SUPPORT AND OPPOSITION:
Support:
None on file as of June 7, 2016.
Opposition:
None on file as of June 7, 2016.
-- END --
Date of Hearing: April 12, 2016
ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS
Rudy Salas, Chair
ABPCA Bill Id:AB 2679
Author:(Cooley) – As Amended Ver:March 18, 2016
SUBJECT: Medical marijuana: regulation: research.
SUMMARY: This bill increases the reporting requirements of the Bureau of Medical Marijuana Regulation (Bureau) to include the number of appeals of denial of state licenses or other disciplinary actions taken by the licensing authorities, the number of complaints submitted to the Bureau regarding licenses; and, expands the California Marijuana Research Program within the University of California to include in its studies the effect of marijuana on a person’s motor skills.
EXISTING LAW:
- Establishes the Bureau of Medical Marijuana to oversee the licensing and regulation of medical marijuana. (Business and Professions Code (BPC) Section 19300, et seq.)
- Defines “cannabis” to be all parts of the Cannabis plant for specified species, whether growing or not; the seeds thereof; the resin, whether crude or purified, extracted from any part of the plant; and every compound, manufacture, salt, derivative, mixture, or preparation of the plant, its seeds, or resin. (BPC Section 19300.5(f))
- Defines “commercial cannabis activity” as the cultivation, possession, manufacture, processing, storing, laboratory testing, labeling, transporting, distribution, or sale of medical cannabis or a medical cannabis product, except as specified. (BPC Section 19300.5(k))
- Defines a “licensing authority” to be the state agency responsible for the issuance, renewal, or reinstatement of the license, or the state agency authorized to take disciplinary action against the license. (BPC Section 19300.5 (w))
- Defines “medical cannabis,” “medical cannabis product,” or “cannabis product” as a product containing cannabis, including, but not limited to, concentrates and extractions, intended to be sold for use by medical cannabis patients in California pursuant to the Compassionate Use Act of 1996, also known as Proposition 215. (BPC Section 19300.5(ag))
- Defines sub-classifications within the categories of cultivation, manufacturer, testing, dispensary, distribution and transporter, as specified. (BPC Section 19300.7)
- Provides that grounds for disciplinary action include failure to comply with the any rule or regulation set by the Bureau; any other grounds contained in regulations adopted by a licensing authority pursuant to the regulation of medical marijuana; failure to comply with any state law, except as specified. (BPC Section 19311)
- Provides that each licensing authority may suspend or revoke licenses, after proper notice and hearing to the licensee, if the licensee is found to have committed any action that is grounds for disciplinary action; may take disciplinary action against a licensee for any violation when the violation was committed by the licensee’s agent or employee while acting on behalf of the licensee or engaged in commercial cannabis activity; and must inform the Bureau, which will in turn inform all other licensing authorities and the Department of Food and Agriculture. (BPC Sections 19312 - 19313.5)
- Requires a licensing authority to deny an application if either the applicant or the premises for which a state license is applied does not qualify, as specified. (BPC Section 19323)
- Requires a licensing authority to notify the applicant, in writing, upon the denial of any application for a license; within 30 days of service of the notice, the applicant may file a written petition for a license with the licensing authority; and, upon receipt of a petition, the licensing authority is required to set the petition for hearing. (BPC Section 19324)
- Requires each licensing authority to submit, beginning on March 1, 2023, and on or before March 1 of each following year, to the Legislature an annual report on the authority’s activities and post the report on the authority’s Internet Web site; the report must include, but not be limited to, the following information for the previous fiscal year:
- The amount of funds allocated and spent by the licensing authority for medical cannabis licensing, enforcement, and administration;
- The number of state licenses issued, renewed, denied, suspended, and revoked, by state license category;
- The average time for processing state license applications, by state license category;
- The number and type of enforcement activities conducted by the licensing authorities and by local law enforcement agencies in conjunction with the licensing authorities or the bureau; and,
- The number, type, and amount of penalties, fines, and other disciplinary actions taken by the licensing authorities. (BPC Section 19353)
- Requires the Bureau to contract with the California Marijuana Research Program (CMRP), known as the Center for Medicinal Cannabis Research (CMCR), authorized pursuant to Section 11362.9 of the Health and Safety Code (HSC), to develop a study that identifies the impact of cannabis on motor skills.
- Establishes the CMRP within the University of California (UC) to study the efficacy and safety of administering marijuana as part of medical treatment; specifies program parameters that the CMRP must develop in order to solicit proposals for research projects, including but not limited to:
- Demonstrating the use of key personnel;
- Procedures for patient outreach;
- Protocols for studying serious illnesses, as specified;
- Proper facilities, i.e. specimen laboratories and suitable equipment to analyze marijuana;
- Adequate information technology systems, i.e. patient registry and data collection; and
- Maintaining objectivity and scientific merit. (HSC Section 11362.9)
THIS BILL:
- Requires the Bureau to comply with the reporting requirements pursuant to Government Code 9795.
- Requires the licensing authorities to include in its annual report to the Bureau:
- The number of appeals of denial of state licenses or other disciplinary actions taken by the licensing authorities, and the amount of time spent on these appeals; and,
- The number of complaints submitted by citizens or representatives of cities or counties regarding licensees, provided as both by statewide and geographical region.
- Expands the CMRP program parameters to include studies to ascertain the effect of marijuana on motor skills.
FISCAL EFFECT: Unknown. This bill is keyed fiscal by the Legislative Counsel.
COMMENTS:
Purpose. This bill increases the reporting requirements of the Bureau of Medical Marijuana Regulation (Bureau) to include the number of appeals of denial of state licenses or other disciplinary actions taken by the licensing authorities, the number of complaints submitted to the Bureau regarding licenses; and, expands the California Marijuana Research Program within the University of California to include in its studies the effect of marijuana on a person’s motor skills.
This bill is sponsored by the author. According to the author, “The Medical Marijuana Regulation and Safety Act [(Act)] was a huge step forward in regulating the medical cannabis industry which has effectively operated in a legal gray area since the passage of [Proposition] 215. The [Act]’s passage last year created a robust administrative and regulatory structure at the state and local level over this industry. As California ramps up its licensing program, proper accountability and oversight are important to make certain state agencies are functioning efficiently and that community input is being effectively considered and tracked. [This bill] increases the reporting requirements regarding licensure denials, time of appeals, and citizen complaints to ensure the Bureau is operating in a timely manner and citizen complaints are being heard.”
The Compassionate Use Act of 1996 (CUA). Proposition 215 was approved by California voters to exempt certain patients and their primary caregivers from criminal liability under state law for the possession and cultivation of marijuana. Proposition 215 was enacted to “ensure that seriously ill Californians have the right to obtain and use marijuana for medical purposes where that medical use is deemed appropriate and has been recommended by a physician who has determined that the person’s health would benefit from the use of marijuana,” and to “ensure that patients and their primary caregivers who obtain and use marijuana for medical purposes upon the recommendation of a physician are not subject to criminal prosecution or sanction.”
The Medical Marijuana Program Act. SB 420 (Vasconcellos), Chapter 875, Statutes of 2003, established the Medical Marijuana Program Act (MMP). The MMP, among other things, required the California Department of Public Health (CDPH) to establish and maintain a program for a statewide identification card system. Medical marijuana identification cards are intended to help law enforcement officers identify and verify that cardholders are able to cultivate, possess, and transport certain amounts of marijuana without being subject to arrest under specific conditions. All counties participate in the identification card program; however, participation by patients and primary caregivers in the identification card program is voluntary.
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.
Since the passage of Proposition 215, a flood of medical marijuana collectives and cooperatives have created a patchwork of local regulations for these industries and with little statewide involvement.
The Federal Controlled Substances Act. Despite the CUA and SB 420, marijuana is still illegal under federal law. Adopted in 1970, the Controlled Substances Act (CSA) established a federal regulatory system designed to combat recreational drug abuse by making it unlawful to manufacture, distribute, dispense, or possess any controlled substance. (Title 21 United States Code Section (USC) 801, et seq.) 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 CSA, 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.
Congress has provided that states are free to regulate in the area of controlled substances, including marijuana, provided that state law does not positively conflict with the CSA. (Title 21 USC Section 903.) Proposition 215, nor the MMP, conflicts with the CSA because medical marijuana use has not been “legalized” medical marijuana in the state; instead, California has tried to avoid this conflict by not pursuing the state's powers to punish certain offenses when a physician has recommended marijuana as a treatment for a serious medical condition.
Center for Medicinal Cannabis Research. According to the CMCR, “The [CMCR] was created in 2000 to conduct clinical and pre-clinical studies of cannabinoids, including smoked marijuana, to provide evidence one way or the other to answer the question “Does marijuana have therapeutic value?” To accomplish this objective, the CMCR issued calls for applications from researchers at leading California institutions, developed a close working relationship with state and federal agencies to gain regulatory approvals, established panels of nationally-recognized experts to rigorously review the merit of applications, and funded carefully designed studies that have now been published in high impact scientific journals, making significant contributions to the available literature on cannabis and the cannabinoids.”
The CMCR continues, “As a result of this program of systematic research, we now have reasonable evidence that cannabis is a promising treatment in selected pain syndromes caused by injury or diseases of the nervous system, and possibly for painful muscle spasticity due to multiple sclerosis. Obviously more research will be necessary to elucidate the mechanisms of action and the full therapeutic potential of cannabinoid compounds. Meanwhile, the knowledge and new findings from the CMCR provide a strong science-based context in which policy makers and the public can discuss the place of these compounds in medical care.”
The Medical Marijuana Regulation and Safety Act. The Act consisted of three separate bills which were enacted together on Sept 11, 2015, to bring licensure and regulation to the medical marijuana industry nearly 20 years after the passage of Proposition 215 in 1996, which legalized the use of medical marijuana. The bills created a comprehensive state licensing system for the commercial cultivation, manufacture, retail sale, transport, distribution, delivery, and testing of medical cannabis. In addition, the bills affirm local control and require licensure by both a local government and the state in order for a licensee to operate. The Act went into effect on January 1, 2016, although licensure requirements will not go into effect until the regulatory entities responsible for implementing the act pass necessary regulations.
Among other things, the Act establishes the new Bureau under the DCA, which is responsible for licensing and regulating dispensaries, transporters, and distributors. In addition, the CDPH is responsible for regulating manufacturers, testing laboratories, and the production and labeling of edible medical marijuana products. The CDFA is responsible for regulating cultivation, and other state agencies, such as the Department of Pesticide Regulation and the State Water Resources Control Board, are responsible for developing environmental standards.
Under the Act, applicants seeking licensure to cultivate, distribute, or manufacture medical cannabis are required to include a detailed description of the applicant's operating procedures for cultivation, extraction and infusion methods, transportation process, inventory procedures, and quality control procedures.
Current Related Legislation. AB 26 (Jones-Sawyer) of the current legislative session requires a licensee under the Act to institute and maintain a training program to educate, inform, and train the licensee's agents and employees regarding compliance with the Act, and requires the Bureau to approve and regulate the training programs. STATUS: This bill is pending in the Senate Committee on Business, Professions and Economic Development.
AB 567 (Gipson) of the current legislative session, would prohibit mobile, vehicular, or technology platforms that enable qualified patients or primary caregivers to arrange for any delivery with a third party; would provide that a dispensary that employs or uses the services of any person under 21 years of age for the sale or delivery of medical cannabis or medical cannabis products is subject to suspension or revocation of certain state or local licenses; and would require tax penalty amnesty programs, for medical cannabis-related businesses, as provided. STATUS: This bill is pending in the Senate Committee on Health.
AB 1548 (Wood) of the current legislative session, would impose a tax in specified amounts on the distribution in this state by a cultivator of marijuana to a licensed distributor, as specified; require the licensed distributor to collect the tax from the cultivator and remit it to the BOE; and require all moneys, less refunds and costs of administration, to be deposited into the Marijuana Production and Environment Mitigation Fund, as specified. This measure died in the Assembly Committee on Revenue and Taxation.
AB 1575 (Bonta) of the current legislative session makes a number of changes to the Act including, among others: specifies that it is not a violation of state law for certain licensees to sell medical cannabis under 8 ounces; specifies that no individual or group may cultivate or distribute cannabis other than what is specified in the Act or the Compassionate Use Act; and, exempts any commercial cannabis activity by a holder of a state license who complies with the Act. STATUS: This bill is pending in the Assembly Committee on Business and Professions.
AB 2385 (Jones-Sawyer) of the current legislative session prohibits licensing authorities from requiring a local license, permit, or other authorization, and would require the issuance of a state license, if the authorities determine that the applicant meets all of the requirements of the act, as specified, in the City of Los Angeles. STATUS: This bill is pending in the Assembly Committee on Business and Professions.
AB 2516 (Wood) of the current legislative session provides for the issuance of a Type 1C, or “specialty cottage,” state cultivator license, as specified, by the CDFA. STATUS: This bill is pending in the Assembly Committee on Agriculture.
AB 2545 (Bonta) of the current legislative session authorizes the Governor to enter into agreements with federally recognized sovereign Indian tribes, as defined; authorizes these agreements to include provisions regulating activities between licensees operating on and off the land of federally recognized sovereign Indian tribes; authorizes the Governor to delegate to the chief of the Bureau authority to negotiate these agreements. STATUS: This bill is pending in the Assembly Committee on Business and Professions.
Prior Related Legislation. AB 266 (Bonta, Cooley, Jones-Sawyer, Lackey, and Wood), Chapter 689, Statutes of 2015, enacted the Act for the licensure and regulation of medical marijuana and established the Bureau within the DCA, under the supervision and control of the Director of the DCA, and required the Director to administer and enforce the provisions of the Act. AB 266 also required the CDFA to administer the provisions of the act related to cultivation, and required the CDPH to administer the provisions of the Act related to manufacturing and testing of medical cannabis. The bill also required the BOE, in consultation with the CDFA, to adopt a system for reporting the movement of commercial cannabis and cannabis products.
AB 243 (Wood), Chapter 688, Statutes of 2015, required the CDFA, the DPR, the CDPH, the DFW, and the SWRCB to promulgate regulations or standards relating to medical marijuana and its cultivation, as specified, required various state agencies to take specified actions to mitigate the impact that marijuana cultivation has on the environment, and established the Act Fund.
SB 643 (McGuire), Chapter 719, Statutes of 2015, set forth standards for a physician and surgeon prescribing medical cannabis, required the Medical Board of California to prioritize its investigative and prosecutorial resources to identify and discipline physicians and surgeons that have repeatedly recommended excessive cannabis to patients for medical purposes or repeatedly recommended cannabis to patients for medical purposes without a good faith examination, as specified, authorized counties to impose a tax upon specified cannabis-related activity, and set forth standards for the licensed cultivation of medical cannabis.
REGISTERED SUPPORT:
None on file.
REGISTERED OPPOSITION:
None on file.
Analysis Prepared by: Gabby Nepomuceno / B. & P. / (916) 319-3301
Discussed in Hearing
Assembly Floor
Senate Floor
Senate Standing Committee on Business, Professions and Economic Development
Assembly Standing Committee on Business and Professions
Bill Author
Bill Co-Author(s):