Amended in Senate August 19, 2016

Amended in Assembly March 18, 2016

California Legislature—2015–16 Regular Session

Assembly Bill No. 2679

Introduced by Assembly begin delete Member Cooley end delete begin insert Members Cooley, Bonta, Jones-Sawyer, Lackey, and Wood end insert

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(Coauthor: Assembly Member McCarty)

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February 19, 2016

An act to amend Section 19353 of the Business and Professions Code, and to amend begin delete Section end delete begin insert Sections 11362.775 and end insert 11362.9 of the Health and Safety Code, relating to medical marijuana.

LEGISLATIVE COUNSEL’S DIGEST

AB 2679, as amended, Cooley. Medical marijuana: regulation: research.

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Existing

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begin insert (1) end insert begin insert   end insert begin insert Existing end insert law, the Medical Marijuana Regulation and Safety begin delete Act, end delete begin insert Act (MMRSA), end insert 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 authority’s activities and post the report on the authority’s 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.

begin delete

Existing

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begin insert (2) end insert begin insert   end insert begin insert Existing end insert 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.

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(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.

end insert begin insert

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.

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Vote: majority. Appropriation: no. Fiscal committee: yes. State-mandated local program: no.

The people of the State of California do enact as follows:

SECTION 1.  

Section 19353 of the Business and Professions
Code is amended to read:

19353.  

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 authority’s
activities, in compliance with Section 9795 of the Government
Code, and post the report on the authority’s 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.

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begin insert SEC. 2. end insert   

end insert

begin insert Section 11362.775 of the end insert begin insert Health and Safety Code end insert begin insert is
amended to read: end insert

11362.775.  

(a) Subject to subdivision begin delete (b), end delete begin insert (d), end insert 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.

begin insert

(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:

end insert begin insert

(1) The collective or cooperative does either or both of the
following:

end insert begin insert

(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.).

end insert begin insert

(B) Utilizes only manufacturing processes that use solvents
exclusively within a closed-loop system that meets all of the
following requirements:

end insert begin insert

(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.).

end insert begin insert

(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.

end insert begin insert

(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).

end insert begin insert

(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.

end insert begin insert

(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.

end insert begin insert

(3) The collective or cooperative meets required fire, safety,
and building code requirements in one or more of the following:

end insert begin insert

(A) The California Fire Code.

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(B) The National Fire Protection Association (NFPA) standards.

end insert begin insert

(C) International Building Code (IBC).

end insert begin insert

(D) The International Fire Code (IFC).

end insert begin insert

(E) Other applicable standards, including complying with all
applicable fire, safety, and building codes in processing, handling,
and storage of solvents or gasses.

end insert begin insert

(4) The collective or cooperative is in possession of a valid
seller’s permit issued by the State Board of Equalization.

end insert begin insert

(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.

end insert begin insert

(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.

end insert begin delete

(b)

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begin insert (d) end insert  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).

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(c)

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begin insert (e) end insert  This section is repealed one year after the date upon which
the notice is posted pursuant to subdivision begin delete (b). end delete begin insert (d). end insert

begin delete SEC. 2. end delete

begin insert SEC. 3. end insert   

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 marijuana’s
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 begin delete the end delete acquired
immunodeficiency syndrome (AIDS) or begin delete the end delete 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 marijuana’s
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.