DEPARTMENT OF LICENSING AND REGULATORY AFFAIRS
MARIJUANACANNABIS
REGULATORY AGENCY
MARIHUANA LICENSESRULES
Filed with the secretary of state on
These rules become
effective immediately after filing with the secretary of state unless adopted
under section 33, 44, or 45a(9) of the administrative procedures act of 1969,
1969 PA 306, MCL 24.233, 24.244, or 24.245a. Rules adopted under these
sections become effective 7 days after filing with the secretary of state.Except
for R 420.218a, these rules become effective 180 days after filing with the
secretary of state. R 420.218a takes effect immediately upon filing with the
secretary of state.
(By authority conferred on the executive director of the marijuanacannabis
regulatory agency by section 206 of the medical marihuana facilities licensing
act, 2016 PA 281, MCL 333.27206, sections 7 and 8 of the Michigan Regulation
and Taxation of Marihuana Act, 2018 IL 1, MCL 333.27957 and 333.27958, and Executive
Reorganization Order No. 2019-2, MCL 333.27001)
R 420.1, R 420.2, R 420.3, R 420.4, R 420.5, R 420.6, R 420.7, R 420.8, R 420.10, R 420.11, R 420.12, R 420.13, R 420.14, R 420.15, R 420.16, R 420.17, R 420.18, R 420.19, R 420.20, R 420.21, R 420.22, R 420.23, R 420.24, R 420.101, R 420.102, R 420.103, R 420.104, R 420.105, R 420.106, R 420.107, R 420.108, R 420.109, R 420.110, R 420.201, R 420.202, R 420.203, R 420.204, R 420.205, R 420.206, R 420.207, R 420.208, R 420.209, R 420.210, R 420.211, R 420.212, R 420.213, R 420.214, R 420.215, R 420.301, R 420.302, R 420.303, R 420.304, R 420.305, R 420.306, R 420.307, R 420.308, R 420.401, R 420.402, R 420.403, R 420.404, R 420.405, R 420.501, R 420.502, R 420.503, R 420.504, R 420.505, R 420.506, R 420.507, R 420.508, R 420.602, R 420.602a, R 420.603, R 420.702, R 420.703, R 420.704, R 420.704a, R 420.705, R 420.706, R 420.707, R 420.708, R 420.709, R 420.801, R 420.802, R 420.803, R 420.804, R 420.805, R 420.806, R 420.807, R 420.808, R 420.1001, R 420.1002, R 420.1003, and R 420.1004 of the Michigan Administrative Code are amended, R 420.2a, R 420.2b, R 420.4a, R 420.8a, R 420.9, R 420.19a, R 420.201a, R 420.201b, R 420.201c, R 420.203a, R 420.205a, R 420.216, R 420.217, R 420.218, R 420.218a, R 420.219, R 420.220, R 420.221, R 420.306a, R 420.306b, R 420.306c, R 420.306d, R 420.306e, R 420.309, R 420.310, R 420.311, R 420.311a, R 420.312, R 420.313, R 420.314, R 420.402a, R 420.402b, R 420.403a, R 420.405a, R 420.405b, R 420.406, R 420.407, R 420.408, R 420.409, R 420.604, R 420.806a, R 420.806b, R 420.806c, R 420.806d, and R 420.1005 are added, and R 420.11a, R 420.25, R 420.26, R 420.27, R 420.27a, R 420.27b, R 420.28, R 420.29, R 420.105a, R 420.111, R 420.112, R 420.112a, R 420.113, R 420.206a, R 420.207a, R 420.214a, R 420.214b, R 420.214c, R 420.303a, R 420.305a, R 420.305b, R 420.503a, R 420.509, R 420.510, R 420.511, R 420.601, R 420.701, R 420.808a, R 420.809, R 420.821, R 420.822, and R 420.823 are rescinded, as follows:
PART 1. GENERAL PROVISIONS
R 420.1 Definitions.
Rule 1. (1) As used in these rules:
(a) “Acts” refers to the
medical marihuana facilities licensing act, 2016 PA 281, MCL 333.27101 to
333.27801, and the Michigan Regulation and Taxation of Marihuana Act, 2018 IL
1, MCL 333.27951 to 333.27967, when applicable.
(b) “Administrative procedures act” means the administrative procedures act of 1969, 1969 PA 306, MCL 24.201 to 24.328.
(bc) “Agency”
means the marijuanacannabis regulatory agency.
(d) “Another party" or “other party” means a person with whom a licensee enters a licensing, management, or manufacturing agreement.
(ce)
"Applicant" means a person whothat applies for a
marihuana license, subject to paragraphs (i) and (ii) of this subdivision:
(i) For purposes of this definition, an applicant includes a managerial employee of the applicant, a person holding a direct or indirect ownership interest of more than 10% in the applicant, and the following for each type of applicant:
(A) For an individual or sole proprietorship: the proprietor and spouse.
(B) For a partnership and limited liability partnership: all partners and their spouses.
(C) For a limited partnership and limited liability limited partnership: all general and limited partners, not including a limited partner holding a direct or indirect ownership interest of 10% or less who does not exercise control over or participate in the management of the partnership, and their spouses.
(D) For a limited liability company: all members and managers, not including a member holding a direct or indirect ownership interest of 10% or less who does not exercise control over or participate in the management of the company, and their spouses.
(E) For a privately held corporation: all corporate officers or persons with equivalent titles and their spouses, all directors and their spouses, all stockholders, not including those holding a direct or indirect ownership interest of 10% or less, and their spouses.
(F) For a publicly held corporation: all corporate officers or persons with equivalent titles and their spouses, all directors and their spouses, all stockholders, not including those holding a direct or indirect ownership interest of 10% or less, and their spouses.
(G) For a multilevel
ownership enterprise: anyan entity or person that receives or has
the right to receive more than 10% of the gross or net profit from the
enterprise during anya full or partial calendar or fiscal year.
(H) For a nonprofit corporation: all individuals and entities with membership or shareholder rights in accordance with the articles of incorporation or the bylaws and their spouses.
(I) For a trust: trustees, anyan
individual or body able to control and direct the affairs of the trust, and
anya beneficiary whothat receives or has the right
to receive more than 10% of the gross or net profit of the trust during anya
full or partial calendar or fiscal year and their spouses.
(ii) For purposes of this definition, an applicant does not include:
(A) A person whothat
provides financing to an applicant or licensee under a bona fide financing
agreement at a reasonable interest rate unless the person exercises control
over or participates in the management of the marihuana business.
(B) A franchisor whothat
grants a franchise to an applicant, if the franchisor does not have the
right to receive royalties based upon the sale of marihuana or
marihuana-infused products by the applicant whothat is a
franchisee. Nothing in this subrule shall be construed to preclude a franchisor
from charging an applicant whothat is a franchisee a fixed fee.
As used in this definition, the terms “franchise,” “franchisor,” and
“franchisee” have the meanings set forth in section 2 of the franchise
investment law, 1974 PA 269, MCL 445.1502.
(C) A person receiving reasonable payment for rent on a fixed basis under a bona fide lease or rental obligation unless the person exercises control over or participates in the management of the marihuana business.
(D) A person receiving reasonable payment under a licensing agreement or contract approved by the agency concerning the licensing of intellectual property, including, but not limited to, brands and recipes.
(E) A person whothat
receives a percentage of profits as an employee if the employee does not meet
the definition of “managerial employee” and the employee does not receive more
than 10% of the gross or net profit from the licensee during anya full
or partial calendar or fiscal year.
(F) A personAn
individual who receives a bonus as an employee if the employee is on a
fixed wage or salary and the bonus is not more than 25% of the employee’s
pre-bonus annual compensation or if the bonus is based upon a written
incentive/or bonus program that is not out of the ordinary for
the services rendered.
(f) “Batch” means all marihuana of the same variety that is processed together and exposed to substantially similar conditions throughout processing.
(dg) “Building”
means a combination of materials forming a structure affording facility,
establishment, or shelter for use or occupancy by individuals or property.
Building includes a part or parts of the building and all equipment in the
building. A building does not include a building incidental to the use for
agricultural purposes of the land on which the building is located.
(eh) “Bureau of
fire services” or “BFS” means the bureau of fire services in the department
of licensing and regulatory affairs.
(i) “Class A marihuana microbusiness” means a person licensed under R 420.110.
(j) “Clone” means a replication of a single parent plant through vegetative propagation.
(f) “Common ownership”
means 2 or more state licenses or 2 or more equivalent licenses held by one
person under the Michigan Regulation and Taxation of Marihuana Act.
(gk) “Complete
application” means an application that includes all of the information required
in R 420.2 to R 420.5 and R 420.7 to R 420.10R 420.3 to R 420.8.
(l) “Contested case hearing” means an administrative hearing conducted by an administrative law judge within MOAHR on behalf of the agency in accordance with the acts and these rules.
(m) “Cultivar” means a cultivated variety of a plant species selected for desired traits when propagated by division, root and stem cuttings, offsets, grafting, tissue culture, or carefully controlled seed production to retain those traits.
(n) “Cultivator” means a grower under the MMFLA or a marihuana grower under the MRTMA, or both.
(ho)
“Department” means the department of licensing and regulatory affairs.
(ip) “Designated
consumption establishment” means a commercial space that is licensed by the
agency and authorized to permitallow adults 21 years of age and
older to consume marihuana products at the location indicated on the state
license issued under the Michigan Regulation and Taxation of Marihuana ActMRTMA.
(j) “Director” means the
director of the department of licensing and regulatory affairs or his or her
designee.
(q) “Edible marihuana product” means a marihuana-infused product that is intended for human consumption in a manner other than inhalation. Edible marihuana product does not include a marihuana-infused product that is intended for topical application.
(kr) “Employee”
means a personan individual performing work or service for
compensation. “Employee” does not include individuals providing
trade or professional services who are not normally engaged in the operation of
a marihuana business.
(ls) “Equivalent
licenses” means any of the following held by a person:
(i) A marihuana grower
license of anya class issued under the Michigan Regulation and
Taxation of Marihuana ActMRTMA and a grower license, of anythe
same class, issued under the medical marihuana facilities licensing actMMFLA.
(ii) A marihuana processor
license issued under the Michigan Regulation and Taxation of Marihuana Act MRTMA
and a processor license issued under the medical marihuana facilities
licensing actMMFLA.
(iii) A marihuana retailer
license issued under the Michigan Regulation and Taxation of Marihuana ActMRTMA
and a provisioning center license issued under the medical marihuana
facilities licensing actMMFLA.
(iv) A marihuana secure
transporter license issued under the Michigan Regulation and Taxation of
Marihuana ActMRTMA and a secure transporter license issued under the
medical marihuana facilities licensing actMMFLA.
(v) A marihuana safety
compliance facility license issued under the Michigan Regulation and
Taxation of Marihuana ActMRTMA and a safety compliance facility
license issued under the medical marihuana facilities licensing actMMFLA.
(mt) “Excess
marihuana grower” means a license issued to a person holding 5 class C
marihuana grower licenses and licensed to cultivate marihuana and sell or
otherwise transfer marihuana to marihuana establishmentsperson licensed
under R 420.103.
(u) “Executive director” means the executive director of the agency.
(v) “Final form” means the form marihuana is in when it is available for sale by a marihuana sales location, not including final consumer packaging. For marihuana intended for inhalation, final form means the marihuana concentrate in an e-cigarette or vaping device.
(w) “Full compliance testing” means the full panel of tests in R 420.306 that marihuana must pass before it can be sold or transferred.
(x) “Good agricultural collection practices” or “GACP” means the World Health Organization’s or the American Herbal Products Association’s guidelines regarding the safety, efficacy, and sustainability of medicinal plant material used in herbal medicines.
(y) “Good manufacturing practices” or “GMP” means the United States Food and Drug Administration’s formal regulations regarding the design, monitoring, control, and maintenance of manufacturing processes and facilities intended to ensure that products are manufactured to specific requirements, including identity, strength, quality, and purity.
(z) “Harvest batch” means a designated quantity of dried marihuana flower or trim, leaves, and other marihuana plant material that is a uniform cultivar, harvested in whole or in part at the same time, and cultivated using the same pesticides or other agricultural chemicals.
(naa) “Immature
plant” means a nonflowering marihuana plant that is no taller than 8 inches
from the growing or cultivating medium and no wider than 8 inches, and is
produced from a cutting, clipping, tissue culture, or seedling that is in a
growing or cultivating medium or in a growing or cultivating container.
(bb) “Immature plant batch” means a designated quantity of immature plants.
(cc) “Inactive ingredients” means binding materials, dyes, preservatives, flavoring agents, and other ingredients not derived from the plant cannabis sativa l. Inactive ingredients do not include conventional food ingredients or ingredients that are generally regarded as safe by the United States Food and Drug Administration.
(dd) “Industrial hemp research and development act” means the industrial hemp research and development act, 2014 PA 547, MCL 286.841 to 286.859.
(ee) “Intellectual property” means all original data, findings, or other products of the mind or intellect commonly associated with claims, interests, and rights that are protected under trade secret, patent, trademark, copyright, or unfair competition law and includes brands or recipes.
(ff) “Internal product sample” means a sample of marihuana that a cultivator, producer, or marihuana sales location transfers directly to an employee for the purpose of ensuring the quality of the marihuana or making determinations about whether to sell or transfer the marihuana.
(gg) “Laboratory” means a safety compliance facility under the MMFLA or a marihuana safety compliance facility under the MRTMA, or both.
(hh) “Licensing agreement” means an understanding or contract concerning the licensing of intellectual property related to marihuana between a licensee and another party.
(ii) “Limit of quantitation” or “LOQ” means the minimum concentration or mass of an analyte in a given matrix that can be reported as a quantitative result.
(ojj) “Limited-access
area” means a building, room, or other contiguous area of a marihuana business
where marihuana is grown, cultivated, stored, weighed, packaged, sold, or
processed for sale and that is under the control of the licenseeprocessed,
packaged, or tested.
(kk) “Management agreement” means an understanding or contract between a licensee and another party for the provision of management or other services, but does not include an agreement for the reasonable payment of rent under a bona fide lease or rental obligation unless the other party exercises control over or participates in the management of the marihuana business.
(pll)
“Managerial employee” means those employees who havean employee who
has the ability to control andor direct the affairs of the
marihuana business or havehas the ability to make policy concerning
the marihuana business, or both.
(mm) “Manufacturing agreement” means an understanding or contract between a licensee and another party whereby the licensee agrees to provide marihuana manufacturing or production services for the other party for an agreed on fee, which may be a set price, a price to be determined during or after manufacturing, based on a split of the marihuana, or other terms as agreed upon by the parties.
(2) As used in these rules:
(qa) “Marihuana
business” means a marihuana facility under the medical marihuana facilities
licensing actMMFLA, or a marihuana establishment under the Michigan
Regulation and Taxation of Marihuana ActMRTMA, or both.
(r) “Marihuana business
location plan” means a marihuana facility plan under the medical marihuana
facilities licensing act, or a marihuana establishment plan under the Michigan
Regulation and Taxation of Marihuana Act, or both.
(s) “Marihuana
establishment” means a marihuana grower, marihuana safety compliance facility,
marihuana processor, marihuana microbusiness, marihuana retailer, marihuana
secure transporter, or any other type of marihuana-related business licensed by
the agency under the Michigan Regulation and Taxation of Marihuana Act.
(b) “Marihuana customer” means a registered qualifying patient or registered primary caregiver under the MMFLA, or an individual 21 years of age or older under the MRTMA, or both.
(tc) “Marihuana
event organizer” means a person licensed to apply for a temporary marihuana
event license under these rulesunder R 420.104 to organize and hold
temporary marihuana events.
(u) “Marihuana facility”
means a location at which a licensee is licensed to operate under the medical
marihuana facilities licensing act.
(vd) “Marihuana
license” means a state operating license issued under the medical marihuana
facilities licensing actMMFLA, or a state license issued under the Michigan
Regulation and Taxation of Marihuana ActMRTMA, or both.
(e) “Marihuana plant waste” means a root, stalk, leaf, stem, or root ball of a marihuana plant and associated soil or organic potting media.
(f) “Marihuana pre-roll” means marihuana that in final form consists of a combination of marihuana bud, shake, or trim that is wrapped and sealed in rolling paper and is intended for inhalation in that form.
(w) “Marihuana product”
means marihuana or a marihuana-infused product, or both, as those terms are
defined in the acts unless otherwise provided for in these rules.
(g) “Marihuana sales location” means a provisioning center under the MMFLA or a marihuana microbusiness, class A marihuana microbusiness, or marihuana retailer under the MRTMA, or both.
(xh) “Marihuana
tracking act” means the marihuana tracking act, 2016 PA 282, MCL 333.27901 to
333.27904.
(yi) “Marihuana
transporter” means a secure transporter under the medical marihuana
facilities licensing actMMFLA or a marihuana secure transporter
under the Michigan Regulation and Taxation of Marihuana ActMRTMA,
or both.
(j) “Marihuana waste” means waste that is, or contains, marihuana. Marihuana waste does not include marihuana plant waste.
(k) “Mature plant” means a flowering or nonflowering marihuana plant that has taken root and is taller than 8 inches from the growing or cultivating medium or wider than 8 inches, produced from a cutting, clipping, tissue culture, or seedling, and is in a growing or cultivating medium or in a growing or cultivating container.
(zl) “Medical
marihuana facilities licensing act” or “MMFLA” means the medical marihuana
facilities licensing act, 2016 PA 281, MCL 333.27101 to 333.27801.
(aam) “Michigan
Medical Marihuana Act” means the Michigan Medical Marihuana Act, 2008 IL 1, MCL
333.26421 to 333.26430.
(bbn) “Michigan
Regulation and Taxation of Marihuana Act” or “MRTMA” means the Michigan
Regulation and Taxation of Marihuana Act, 2018 IL 1, MCL 333.27951 to
333.27967.
(o) “MOAHR” means the Michigan office of administrative hearings and rules within the department.
(p) “MOAHR administrative hearing rules” means R 792.10101 to R 792.11903.
(q) “Package tag” means an RFID supplied through the statewide monitoring system for the purpose of identifying a package containing marihuana.
(r) “Parties” means a licensee and another party pursuant to a licensing, management, manufacturing, or other agreement.
(s) “Plant tag” means an RFID tag supplied through the statewide monitoring system for the purpose of identifying an individual marihuana plant.
(t) “Producer” means a processor under the MMFLA or a marihuana processor under the MRTMA, or both.
(u) “Production batch” means a designated quantity of marihuana that is created from a processing job in the statewide monitoring system during which the marihuana undergoes extraction or the incorporation of other ingredients.
(ccv) “Proposed
marihuana business” means a proposed marihuana establishment under the Michigan
Regulation and Taxation of Marihuana ActMRTMA or a proposed
marihuana facility under the medical marihuana facilities licensing actMMFLA,
or both.
(w) “Public investigative hearing” means a hearing in which an applicant or licensee has an opportunity to present testimony and evidence to establish eligibility and suitability for a marihuana license.
(x) “Reasonable payment” means payment of 10% or less of the total on a licensee’s trial balance sheet during a full or partial calendar or fiscal year.
(y) “Records of formulation” means all of the following for a marihuana-infused product:
(i) The list of ingredients and their certificates of analysis.
(ii) The recipe.
(iii) A description of the process in which ingredients are combined to produce marihuana in final form.
(dd) “Restricted access
area” means a designated and secure area at a marihuana business where
marihuana products are sold, possessed for sale, or displayed for sale.
(z) “Tag” or “RFID tag” means the unique identification number or radio frequency identification issued to a licensee by the statewide monitoring system for identifying and tracking marihuana in the statewide monitoring system.
(aa) “Temporary marihuana event license” means a state license issued under part 3 of these rules to a marihuana event organizer for the onsite sale or transfer of marihuana at a location other than the location of a marihuana retailer, marihuana microbusiness, or class A marihuana microbusiness.
(eebb) “These
rules” means the administrative rules promulgated by the agency under the
authority of the medical marihuana facilities licensing actMMFLA,
the marihuana tracking act, the Michigan Regulation and Taxation of
Marihuana ActMRTMA, and Executive Reorganization Order No. 2019-2,
MCL 333.27001.
(ff) “Same location” means
separate marihuana licenses that are issued to multiple marihuana businesses
that are authorized to operate at a single property but with separate business
suites, partitions, or addresses.
(gg) “Special license”
means a state license as described under section 8 of the Michigan Regulation
and Taxation of Marihuana Act, MCL 333.27958, and issued pursuant to section 9
of that act, MCL 333.27959.
(hh) “Stacked license”
means more than 1 marihuana license issued to a single licensee to operate as a
class C grower as specified in each license at a marihuana business under the
medical marihuana facilities licensing act, or under the Michigan Regulation
and Taxation of Marihuana Act, or both.
(ii) “Tag” or “RFID tag”
means the unique identification number or Radio Frequency Identification (RFID)
issued to a licensee by the statewide monitoring system for tracking,
identifying, and verifying marihuana plants, marihuana products, and packages
of marihuana product in the statewide monitoring system.
(jj) “Temporary marihuana
event license” means a state license held by a marihuana event organizer under
the Michigan regulation and taxation of marihuana act, for an event where the
onsite sale or consumption of marihuana products, or both, are authorized at
the location indicated on the state license.
(cc) “Trade sample” means a sample of marihuana that a cultivator or producer provides to another marihuana business for the purpose of the marihuana business determining whether to purchase the marihuana.
(23) Terms
defined in the acts have the same meanings when used in these rules unless
otherwise indicated.
R 420.2 Licensure;
application; background investigation; consent to inspections, investigations,
and audits; disclosure of confidential records; interest in other state
license; fee; additional costs. Adoption by reference.
Rule 2. (1) A person may
apply to the agency for marihuana licenses and special licenses as provided in
the acts and these rules.
(2) The agency shall use
information provided on the application as a basis to conduct a thorough
background investigation on the applicant. The agency shall notify the
applicant of a deficiency and provide instructions for submitting a complete
application. The applicant shall timely respond to the notice of the
deficiency in accordance with R. 420.5.
(3) An applicant must
provide written consent to investigations of compliance, regular inspections,
examinations, searches, seizures, and auditing of books and records and to
disclosure to the agency and its agents of otherwise confidential records,
including tax records held by any federal, state, or local agency, or credit
bureau or financial institution, while applying for or holding a marihuana license
as authorized under the acts and these rules.
(4) An applicant must
certify that the applicant does not have any interest in any other marihuana
license that is prohibited under the acts.
(5) A nonrefundable
application fee must be paid at the time of filing to defray the costs
associated with the background investigation conducted by the agency. The
agency shall set the amount of the application fee for each category and class
of license by rule. If the costs of the investigation and processing the application
exceed the application fee, the applicant shall pay the additional amount to
the agency. All information, records, interviews, reports, statements,
memoranda, or other data supplied to or used by the agency in the course of its
review or investigation of an application for a marihuana license under the
acts shall be disclosed only in accordance with the acts. (1) The
following codes, standards, and regulations that have been adopted by
nationally recognized organizations or associations or an agency of the United
States are adopted by reference in these rules:
(a) National fire protection association (NFPA) standard 1, 2021 edition, entitled, “Fire
Code.” Copies of the adopted provisions are available for inspection and distribution from the National Fire Protection Association, 1 Batterymarch Park, P.O. Box 9101, Quincy, Massachusetts, 02169, telephone number 1-800-344-3555, for the price of $155.00.
(b) National fire protection association (NFPA) standard 58, 2020 edition, entitled, “Liquified Petroleum Gas Code.” Copies of the adopted provisions are available for inspection and distribution from the National Fire Protection Association, 1 Batterymarch Park, P.O. Box 9101, Quincy, Massachusetts, 02169, telephone number 1-800-344-3555, for the price of $70.50.
(c) AOAC International Official Methods of Analysis, 22nd edition. Copies of the adopted provisions are available for inspection and distribution from the Association of Official Analytical Collaboration (AOAC) International, 2275 Research Boulevard, Suite 300, Rockville, Maryland, 20850, telephone number 1-800-379-2622, for the price of $950.00.
(d) International Organization for Standardization (ISO), ISO/IEC 17025:2017, General Requirements for the Competence of Testing and Calibration Laboratories, available at: https://webstore.ansi.org/RecordDetail.aspx?sku=ISO%2fIEC+17025%3a2017, for the price of $162.00.
(e) International Organization for Standards (IS0), ISO/IEC 17065:2012, Conformity Assessment – Requirements for Bodies Certifying Products, Processes and Services, available at: https://webstore.ansi.org/Standards/ISO/ISOIEC170652012, for the price of $175.00.
(f) International Organization for Standards (IS0), ISO/IEC 17043:2023, Conformity Assessment – General Requirements for Proficiency Testing, available at: https://webstore.ansi.org/Standards/ISO/ISOIEC170432010, for the price of $200.00.
(g) The provisions of 21 CFR, part 117, “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food,” revised July 29, 2016, available at no charge from the Office of the Federal Register at www.ecfr.gov.
(h) The provisions of 40 CFR, part 136, “Guidelines Establishing Test Procedures for the Analysis of Pollutants,” revised August 15, 2024, available at no charge from the Office of the Federal Register at www.ecfr.gov.
(i) The provisions of 40 CFR, part 160, “Good Laboratory Practice Standards,” revised December 12, 2008, available at no charge from the Office of the Federal Register at www.ecfr.gov.
(2) The standards adopted in subrule (1)(a) to (f) of this rule are available for inspection and distribution at the agency, located at 2407 North Grand River Avenue, Lansing, Michigan, 48906. Copies of these standards may be obtained from the agency at the cost indicated in subrule (1)(a) to (f) of this rule, plus shipping and handling.
R 420.2a Other applicable statutes.
Rule 2a. (1) A licensee shall comply with the requirements of applicable statutes in the Michigan compiled laws and is responsible for knowing the applicability of those laws to the licensee’s business. Applicable laws include, but are not limited to, all of the following:
(a) The weights and measures act, 1964 PA 283, MCL 290.601 to 290.635.
(b) The natural resources and environmental protection act, 1994 PA 451, MCL 324.101 to 324.90106.
(c) The Michigan occupational safety and health act, 1974 PA 154, MCL 408.1001 to 408.1094.
(d) The General Sales Tax Act, 1933 PA 167, MCL 205.51 to 205.78.
(e) The income tax act of 1967, 1967 PA 281, MCL 206.1 to 206.847.
(f) The general property tax act, 1893 PA 206, MCL 211.1 to 211.155.
(g) The Michigan limited liability company act, 1993 PA 23, MCL 450.4101 to 450.5200.
(h) The business corporation act, 1972 PA 284, MCL 450.1101 to 450.2098.
(i) 1907 PA 101, MCL 445.1 to 445.5.
(j) The Stille-DeRossett-Hale single state construction code act, 1972 PA 230, MCL 125.1501 to 125.1531.
R 420.2b Severability.
Rule 2b. If a rule or subrule of these rules, in whole or in part, is found to be invalid by a court of competent jurisdiction, this decision will not affect the validity of the remaining portion of these rules.
PART 2. APPLICATIONS AND LICENSING
R 420.3 Application
procedure; requirements Prequalification; application process.
Rule 3. (1) A person shall
apply for a marihuana license on the form created by the agency and pay a
nonrefundable application fee at the time the application is submitted. The
applicant shall answer each question on the application, under oath, in its
entirety. All attestations, disclosures, and information requested and required
by the agency, the acts, and these rules must be submitted in the application.
Failure to comply with these rules and the application requirements in the acts
is grounds for denial of the application.
(2) A person may submit a
partial application under these rules on the condition that it is to prequalify
to complete the remaining application requirements. This application has a
pending status until all application requirements in these rules are completed,
or the agency denies the partial or complete application. The agency shall not
issue a marihuana license at this stage of the application process. The
finding of prequalification status for a pending application is valid for 2
years after the agency issues a notice of prequalification status. After 2
years has expired, the applicant may be required to submit a new application
and pay a new nonrefundable application fee.
(3) A partial application
filed to obtain prequalification status may be administratively withdrawn if
the application was filed and has been pending for more than 1 year. After a
partial application has been administratively withdrawn, the applicant may be
required to submit a new application and pay a new nonrefundable application
fee.
(4) The agency may request
additional disclosures and documentation from an applicant. The applicant
shall submit the information requested by the agency within 5 days pursuant to
R. 420.5 or the application may be denied.
(5) The agency may administratively
withdraw an application for a marihuana license that was submitted and has been
pending for more than 1 year. After an application has been administratively
withdrawn, the applicant may be required to submit a new application.
(6) The agency may
administratively withdraw an amendment to any application or marihuana license
if the applicant or licensee fails to respond or submit documentation to cure
all deficiencies within 30 days after notice of the deficiency. (1) An
applicant may apply for prequalification by submitting the information,
disclosures, documents, and attestations required under R 420.4 and a
nonrefundable application fee of $3,000.00 to defray the costs associated with
the background investigation conducted by the agency and processing the
application.
(2) An applicant for prequalification shall notify the agency in a timely manner if information provided to the agency as part of the prequalification application changed after the application was submitted.
(3) Except as provided in subrule (6) of this rule, an applicant’s prequalification status is valid for 2 years after the agency issues a notice of prequalification status.
(4) The agency may administratively withdraw an application for prequalification if the application was submitted and is pending for more than 1 year.
(5) If the agency identifies a deficiency in a prequalification application, the agency shall notify the applicant of the deficiency and provide instructions for correcting the deficiency in the prequalification application. The applicant shall submit the missing information or proof that the deficiency has been corrected to the agency within 5 days after the date the applicant received the deficiency notice.
(6) The agency may revoke an applicant’s prequalification status if it determines that the applicant no longer meets the eligibility requirements for prequalification.
(7) Except as provided in R 420.19a, if an applicant that previously applied for prequalification submits a new application for prequalification, the applicant shall pay a new application fee.
(8) If the costs of the investigation and processing the prequalification application exceed the application fee, the applicant shall pay an additional amount sufficient to cover the additional costs.
(9) The agency shall use the information provided in the prequalification application to conduct a background investigation on the applicant.
R 420.4 Application
requirements; financial and criminal background Prequalification;
requirements.
Rule 4. (1) Each applicant
shall disclose the identity of any other person who controls, either directly
or indirectly, the applicant, including, but not limited to, date of birth,
government issued identification, and any other documents required by the
agency.
(2) Each applicant shall
disclose the financial information required in the acts and these rules on a
form created by the agency, which may include the following:
(a) For an applicant
seeking licensure under the MMFLA, required information may include, but is not
limited to, all of the following:
(i) Financial statements
regarding all of the following:
(A) A pecuniary interest.
(B) Any deposit of value
of the applicant or made directly or indirectly to the applicant, or both.
(C) Financial accounts
including, but not limited to, all of the following: funds, savings, checking,
or other accounts including all applicable account information, such as the
name of the financial institution, names of the account holders, account type,
account balances, and a list of all loans types specified by the agency,
amounts, securities, or lender information.
(ii) Property ownership
information, including, but not limited to, deeds, leases, rental agreements,
real estate trusts, or purchase agreements.
(iii) Tax information,
including, but not limited to, W-2 and 1099 forms, and any other information
required by the agency.
(iv) Disclosure by the
applicant of the identity of any other person who meets either of the
following:
(A) Controls, directly or
indirectly, the applicant.
(B) Is controlled,
directly or indirectly, by the applicant or by a person who controls, directly
or indirectly, the applicant.
(v) The sources and total
amount of the applicant’s capitalization to operate and maintain the proposed
marihuana facility in compliance with R 420.11.
(vi) A financial statement
attested by a certified public accountant (CPA), on a form created by the
agency, including a foreign-attested CPA statement, or its equivalent if
applicable on capitalization pursuant to R 420.11.
(vii) Information on the
financial ability of the applicant to purchase and maintain adequate liability
and casualty insurance in compliance with R 420.10.
(viii) Any other
documents, disclosures, or attestations created or requested by the agency that
are not inconsistent with the acts or these rules.
(b) For an applicant
seeking licensure under the MRTMA all of the following may be required:
(i) Tax information,
including, but not limited to:
(A) W-2 forms for the
most recent tax year.
(B) 1099 forms for the
most recent tax year.
(ii) Any other information
relevant to the application for licensure required by the agency.
(3) Each applicant shall
disclose the identity of every person having a 2.5% or greater ownership interest
in the applicant with respect to which the license is sought.
(a) If the disclosed entity
is a trust, the applicant shall disclose the names and addresses of the
beneficiaries.
(b) If the disclosed entity
is a privately held corporation, the names and addresses of all shareholders,
officers, and directors.
(c) If the disclosed entity
is a publicly held corporation, the names and addresses of all shareholders
holding a direct or indirect interest of greater than 5%, officers, and
directors.
(d) If the disclosed entity
is a partnership or limited liability partnership, the names and addresses of
all partners.
(e) If the disclosed entity
is a limited partnership or limited liability limited partnership, the names of
all partners, both general and limited.
(f) If the disclosed entity
is a limited liability company, the names and addresses of all members and
managers.
(4) Each applicant shall
disclose the applicant’s business organizational documents filed with this
state, any other state, local county, or foreign entity, if applicable,
including proof of registration to do business in this state and certificate of
good standing from this state, any other state, or foreign entity, if
applicable.
(5) Each applicant shall
disclose to the agency criminal and financial background information and
regulatory compliance as provided under the acts and these rules on a form
created by the agency.
(6) Each applicant shall
provide written consent to a criminal and financial background investigation as
authorized under the acts and these rules.
(7) Each applicant shall
provide an attestation acknowledging that sanctions may be imposed for
violations on a licensee while licensed or after the marihuana license has
expired, as provided in the acts and these rules.
(8) Each applicant shall
provide an attestation affirming a continuing duty to provide information
requested by the agency and to cooperate in any investigation, inspection,
inquiry, or hearing.
(9) Each applicant shall
disclose any noncompliance with any regulatory requirements, all legal
judgments, lawsuits, legal proceedings, charges, or government investigations,
whether initiated, pending, or concluded, against the applicant, that are
related to business operations, including, but not limited to fraud,
environmental, food safety, tobacco, alcohol, labor, employment, worker’s
compensation, discrimination, and tax laws and regulations, in this state or
any other jurisdiction.
(10) Each applicant shall
disclose any application or issuance of any commercial license or certificate
issued in this state or any other jurisdiction that meets the requirements
under the acts and these rules.
(11) Each applicant shall
provide any other documents or attestations created by, or make any disclosures
requested by, the agency that are not inconsistent with the acts or these
rules.
(12) An applicant shall
submit in the application any information requested and required by the acts
and these rules.
(13) Each applicant seeking
licensure under the MMFLA must submit one set of fingerprints to the department
of state police in accordance with section 402 of the MMFLA, MCL 333.27402.
(14) Each applicant seeking
licensure under the MRTMA shall provide an attestation acknowledging that the
applicant must have a physical structure for the marihuana establishment and
pass the prelicensure inspection within 60 calendar days of submitting a
complete application to the agency. Failure to pass the prelicensure
inspection within 60 calendar days of submitting the complete application to
the agency may result in the application begin denied in accordance with R
420.12.
(15) An applicant shall
provide an attestation signed by a representative of the department of treasury
and the applicant, verifying that the applicant is not delinquent in the
payment of sales, excise, or any other taxes.
(16) An applicant seeking
licensure under the MRTMA shall provide a social equity plan detailing a plan
to promote and encourage participation in the marihuana industry by people from
communities that have been disproportionately impacted by marihuana prohibition
and enforcement and to positively impact those communities. (1) An
applicant for prequalification shall submit to the agency information,
disclosures, documents, or attestations required by the agency regarding any of
the following:
(a) The identity of an individual who controls, either directly or indirectly, the applicant, the individual’s date of birth, and a copy of the individual’s government-issued identification.
(b) The identity of a person having a 2.5% or greater ownership interest in the applicant according to any of the following:
(i) If the person is a trust, the applicant shall disclose the names and addresses of the beneficiaries of the trust.
(ii) If the person is a privately held corporation, the applicant shall disclose the names and addresses of all officers, directors, and shareholders.
(iii) If the person is a publicly held corporation, the applicant shall disclose the names and addresses of all officers, directors, and shareholders holding a direct or indirect interest of greater than 5%.
(iv) If the person is a partnership or limited liability partnership, the applicant shall disclose the names and addresses of all partners.
(v) If the person is a limited partnership or limited liability limited partnership, the applicant shall disclose the names and addresses of all partners, both general and limited.
(vi) If the person is a limited liability company, the applicant shall disclose the names and addresses of all members and managers.
(c) The applicant’s criminal history.
(d) The applicant’s financial information.
(e) The applicant’s noncompliance with regulatory requirements.
(f) Legal judgments, lawsuits, legal proceedings, charges, or government investigations, whether initiated, pending, or concluded, against the applicant, that are related to the applicant’s business operations, including, but not limited to, fraud, environmental safety, food safety, tobacco, alcohol, labor, employment, worker’s compensation, discrimination, and tax laws and regulations, in this state or another jurisdiction.
(g) An application for or issuance of a license or certificate issued in this state, or another jurisdiction related to activities regulated under the acts and these rules.
(h) Consent to a criminal and financial background investigation.
(i) Consent to investigations of compliance, regular inspections, examinations, searches, seizures, and auditing of books and records.
(j) Consent to disclosure to the agency of otherwise confidential records, including tax records held by a federal, state, or local agency, or credit bureau or financial institution.
(k) Certification that the applicant does not have an interest in another marihuana license that is prohibited under the acts.
(l) Business organizational documents filed with this state, another state, a local county, or a foreign entity, if applicable, including, but not limited to, proof of registration to do business in this state and certificate of good standing from this state, another state, or a foreign entity.
(m) Acknowledgement that sanctions may be imposed for violations of the acts or these rules against a licensee while the licensee is licensed or after the licensee’s marihuana license is closed.
(n) Affirmation of a continuing duty to provide information requested by the agency and to cooperate in an investigation, inspection, inquiry, or hearing.
(o) Verification that the applicant is not delinquent in the payment of sales, excise, or other taxes.
(p) Tax information, including, but not limited to, W-2 and 1099 forms.
(q) Other information, records, documents, disclosures, attestations, interviews, reports, statements, memoranda, or data required by the agency that are not inconsistent with the acts or these rules.
(2) In addition to the requirements under subrule (1) of this rule, an applicant for a state license under the MRTMA shall submit a social equity plan detailing the applicant’s efforts to promote and encourage participation in the marihuana industry by people from communities that have been disproportionately impacted by marihuana prohibition and enforcement and to positively impact those communities.
R 420.4a Prequalification under the MMFLA; financial information; capitalization;
fingerprints.
Rule 4a. (1) In addition to the requirements under R 420.4, an applicant for prequalification under the MMFLA shall submit to the agency information, disclosures, documents, or attestations required by the agency regarding any of the following:
(a) Financial statements regarding all of the following:
(i) A pecuniary interest.
(ii) A deposit of value of the applicant or made directly or indirectly to the applicant, or both.
(iii) Financial accounts, including, but not limited to, all of the following: funds, savings, checking, or other accounts, including all applicable account information, such as the name of the financial institution, names of the account holders, account type, account balances, and a list of all loan types specified by the agency, amounts, securities, or lender information.
(b) Property ownership.
(c) The total amounts of capitalization based on the type of marihuana facility specified in the application for a state operating license, as follows:
(i) Grower - Class A: $150,000.00.
(ii) Grower - Class B: $300,000.00.
(iii) Grower - Class C: $500,000.00.
(iv) Processor: $300,000.00.
(v) Provisioning Center: $300,000.00.
(vi) Secure Transporter: $200,000.00.
(vii) Safety Compliance Facility: $200,000.00.
(d) Proof to the agency of the capitalization amounts specified in paragraphs (i) to (vii) of subdivision (c) of this subrule from both of the following sources:
(i) Not less than 25% in cash or assets easily convertible to cash, including, but not limited to, certificates of deposit, 401(k) plans, stocks, and bonds to cover the initial expenses of operating and maintaining the proposed marihuana facility, as specified in the application.
(ii) The remaining capitalization to cover the initial expenses of operating and maintaining the proposed marihuana facility including, but not limited to, additional assets as described in subdivision (a) of this subrule or equity in real property, supplies, equipment, fixtures, or another nonliquid asset.
(e) Proof that there is no lien or encumbrance, except for a mortgage encumbering the real property, on the asset provided as a source of capitalization. For purposes of this subdivision, if the encumbrance is a mortgage on the real property, the applicant shall disclose the value of the equity of the real property less a mortgage.
(2) The capitalization amounts and sources must be validated by financial statements attested to by a certified public accountant (CPA). The applicant shall disclose if any of the capitalization sources are foreign. A foreign CPA or its equivalent and a domestic CPA shall attest to the foreign validation.
(3) An applicant for prequalification under the MMFLA shall submit 1 set of fingerprints to the department of state police for a criminal history check in accordance with section 402 of the MMFLA, MCL 333.27402.
R. 420.5 Application
requirements; complete application Marihuana license; application
process.
Rule 5. (1) A complete
application for a marihuana license must include all the information required
in R 420.2 to R 420.4, R 420.7 to R 420.10, and all of the following:
(a) A description of the
type of marihuana business that includes all of the following:
(i) An estimate or actual
number of employees.
(ii) A business plan.
(iii) The proposed
location of the marihuana business.
(iv) A security plan, as
required under the acts and these rules.
(b) A copy of the proposed
marihuana business location plan as required under R 420.8.
(c) The disclosure of both
of the following persons:
(i) For an applicant
seeking licensure under the MMFLA, persons that have a beneficial interest as
required in section 303(1)(g) of the MMFLA, MCL 333.27303.
(ii) For an applicant
seeking licensure under the MRTMA, persons who have a direct or indirect
ownership interest in the marihuana establishment.
(d) For an applicant
seeking licensure under the MMFLA, confirmation of municipal compliance on an
attestation form provided by the agency that contains includes all of the
following:
(i) Written affirmation
that the municipality has adopted an ordinance under section 205 of the MMFLA,
MCL 333.27205, including, if applicable, a description of any limitations on
the number of each type of marihuana facility.
(ii) A description of any
regulations within the municipality that apply to the proposed marihuana
business.
(iii) The date and
signature of the clerk of the municipality or his or her designee on the
attestation form attesting that the information stated in the document is
correct.
(iv) The date and
signature of the applicant.
(v) The name and address
of the proposed marihuana business facility name and address.
(vi) The license type of
the proposed marihuana facility.
(vii) Attestation that the
applicant will report any changes that occur with municipal ordinances or
zoning regulations that relate to the proposed marihuana facility, any
municipal facility approvals, or any violations of a municipal or zoning regulation.
(e) For an applicant
seeking licensure under the MRTMA, confirmation of municipal compliance on an
attestation form provided by the agency that includes all of the following:
(i) The name and address
of the proposed marihuana establishment.
(ii) The license type or
the proposed marihuana establishment.
(iii) The municipality
where the proposed marihuana establishment is located.
(iv) The contact
information for the municipality including the following at a minimum:
(A) The name of the clerk
of the municipality or his or her designee.
(B) The telephone number
of the clerk of the municipality or his or her designee.
(C) The email address of
the clerk of the municipality or his or her designee.
(D) The mailing address
of the clerk of the municipality or his or her designee.
(v) Confirmation that the
municipality has not adopted an ordinance prohibiting the proposed marihuana
establishment.
(vi) Confirmation that the
applicant is in compliance with any ordinance the municipality has adopted
relating to marihuana establishments within its jurisdiction, including zoning
regulations.
(vii) Attestation that the
applicant will report any changes that occur with municipal ordinances or
zoning regulations that relate to the proposed marihuana establishment, any
municipal establishment approvals, or any violations of a municipal or zoning
regulation.
(viii) The date and
signature of the applicant.
(2) Each applicant shall
provide any additional information and documents requested by the agency not
inconsistent with the acts and these rules.
(3) Each applicant shall
provide any other documents, disclosures, or attestations created or requested
by the agency that are not inconsistent with the acts and these rules.
(4) If the agency identifies
a deficiency in an application, the agency shall notify the applicant and the
applicant shall submit the missing information or proof that the deficiency has
been corrected to the agency within 5 days of the date the applicant received
the deficiency notice.
(5) The failure of an
applicant to correct a deficiency within 5 days of notification by the agency
may result in the denial of the application. An applicant denied under this
subrule is not barred from reapplying by submitting a new application and
application fee. (1) An applicant that is prequalified under R 420.3 may
apply for a marihuana license in a manner prescribed by the agency and shall
submit all of the following:
(a) An application described in R 420.6.
(b) Proof of financial responsibility described in R 420.7.
(c) A marihuana business location plan described in R 420.8.
(d) A certificate of use and occupancy required under section 13 of the Stille-DeRossett-Hale single state construction code act, 1972 PA 230, MCL 125.1513, and R 420.210. If this certificate is not available, the agency may accept alternative documentation from the building authority.
(e) Proof of a completed fire safety inspection described in R 420.8a, if applicable.
(2) In addition to the requirements under subrule (1) of this rule, an applicant shall provide other information, records, documents, disclosures, attestations, interviews, reports, statements, memoranda, or data required by the agency that are not inconsistent with the acts or these rules.
(3) An applicant for a marihuana license shall notify the agency in a timely manner if information provided to the agency as part of the application changed after the application was submitted.
(4) The agency may administratively withdraw an application for a marihuana license if the application was submitted and is pending for more than 1 year.
(5) If the agency identifies a deficiency in an application, the agency shall notify the applicant of the deficiency and provide instructions for correcting the deficiency in the application. The applicant shall submit the missing information or proof that the deficiency has been corrected to the agency within 5 days after the date the applicant received the deficiency notice. The failure of an applicant to correct a deficiency within 5 days after notification by the agency may result in the denial of the application.
(6) A marihuana license is issued for a 1-year period and is renewable annually.
(7) No information, records, documents, disclosures, attestations, interviews, reports, statements, memoranda, or data provided to or used by the agency during its review or investigation of an application for a marihuana license shall be disclosed except as allowed or required by law.
(8) The agency may determine that a requirement listed in this part of these rules is not applicable to a specific license type and is therefore not required for that license type.
(9) The agency shall not issue a marihuana license until all of the following have been met:
(a) An applicant complies with the requirements of R 420.3 to R 420.8a.
(b) The agency determines that the applicant is qualified to receive a marihuana license.
(c) The applicant pays the fee required under R 420.9.
R 420.6 State license under
the Michigan regulation and taxation of marihuana act; issuance;
qualifications; ineligibility Marihuana license; application
requirements.
Rule 6. (1) The agency shall
not issue a state license under the MRTMA until a complete application is
submitted, the fees required under these rules are paid, and the agency
determines that the applicant is qualified to receive a state license under the
acts and these rules. An applicant under MRTMA must pay initial licensure fees
within 10 calendar days of approval of the state license or within 90 calendar
days of submitting a complete application, whichever date is first. Failure to
pay the fees required under R 420.7 may be grounds for the denial of state
license.
(2) An applicant is
ineligible to receive a state license if any of the following circumstances
exist:
(a) The applicant has a
prior conviction that involved distribution of a controlled substance to a
minor.
(b) The applicant has
knowingly submitted an application for a state license under the MRTMA that
contains false information.
(c) The applicant is an
employee, advisor, or consultant of the agency involved in the implementation,
administration, or enforcement of the MRTMA or these rules pursuant to section
7 of the MRTMA, MCL 333.27957.
(d) The applicant holds an
elective office of a governmental unit of this state, another state, or the
federal government; is a member of or employed by a regulatory body of a
governmental unit in this state, another state, or the federal government, or
is employed by a governmental unit of this state. This subdivision does not
apply to any of the following:
(i) An elected officer of
or employee of a federally recognized Indian tribe.
(ii) An elected precinct
delegate.
(iii) The spouse of a
person who applies for a state license unless the spouse’s position creates a
conflict of interest or is within any of the following:
(A) The marijuana
regulatory agency.
(B) A regulatory body of
a governmental unit in this state, another state, or the federal government
that makes decisions regarding adult-use marijuana.
(e) The agency determines
the municipality in which the applicant’s proposed marihuana establishment will
operate has adopted an ordinance that prohibits marihuana establishments or
that the proposed establishment is noncompliant with an ordinance consistent
with section 6 of the MRTMA, MCL 333.27956.
(f) The applicant will hold
an ownership interest in both a marihuana safety compliance facility or in a
marihuana secure transporter and in a marihuana grower, a marihuana processor,
a marihuana retailer, or a marihuana microbusiness, or a class A marihuana
microbusiness in violation of section 9 of the MRTMA, MCL 333.27959.
(g) The applicant will hold
an ownership interest in both a marihuana microbusiness or a class A marihuana
microbusiness and in a marihuana grower, a marihuana processor, a marihuana
retailer, a marihuana safety compliance facility, or a marihuana secure
transporter, in violation of section 9 of the MRTMA, MCL 333.27959.
(h) The applicant will hold
an ownership interest in more than 5 marihuana growers or in more than 1
marihuana microbusiness or class A marihuana microbusiness, in violation of
section 9 of the MRTMA, MCL 333.27959.
(i) The applicant fails to
meet other criteria established in these rules.
(3) In determining whether
to grant a state license to an applicant, the agency may also consider all of
the following:
(a) Whether the applicant
or anyone meeting the definition of applicant has a pattern of convictions
involving dishonesty, theft, or fraud that indicate the proposed marihuana
establishment is unlikely to be operated with honesty and integrity.
(b) Whether the applicant
has been served with a complaint or other notice filed with any public body
regarding payment of any tax required under federal, state, or local law that
has been delinquent for 1 or more years.
(c) Whether the applicant
has a history of noncompliance with any regulatory requirements, all legal
judgments, lawsuits, legal proceedings, charges, or government investigations,
whether initiated, pending, or concluded, against the applicant, that are
related to business operations, including, but not limited to, fraud,
environmental, food safety, labor, employment, worker’s compensation,
discrimination, and tax laws and regulations, in this state or any other
jurisdiction.
(d) Whether the applicant
meets other standards in rules applicable to the state license category.
(4) The agency shall review
all applications for state licenses and inform each applicant of the agency’s
decision.
(5) An applicant or licensee
has a continuing duty to provide information requested by the agency and to
cooperate in any investigation, inquiry, or hearing conducted by the agency.
(6) A marihuana license is a
revocable privilege granted by the agency and is not a property right. Granting
a marihuana license does not create or vest any right, title, franchise, or
other property interest. A licensee or any other person shall not lease,
pledge, borrow, or loan money against a marihuana license. (1) An
applicant shall submit an application that includes all of the following:
(a) A description of the marihuana business that includes all of the following:
(i) The legal entity name.
(ii) The name under which business is to be transacted at the licensed location, if different from the legal entity name.
(iii) The type of marihuana license for which the applicant is applying.
(iv) A business plan.
(v) The proposed location of the marihuana business.
(vi) Trademarks, service marks, or brands to be used by the licensee, if known at the time of application.
(b) For an applicant seeking licensure under the MMFLA, confirmation of municipal compliance on an attestation form provided by the agency that includes all of the following:
(i) Written affirmation that the municipality has adopted an ordinance under section 205 of the MMFLA, MCL 333.27205, including, if applicable, a description of limitations on the number of each type of marihuana facility.
(ii) A description of regulations within the municipality that apply to the proposed marihuana business.
(iii) The date and signature of the clerk of the municipality or the clerk’s designee on the attestation form attesting that the information stated in the document is correct.
(iv) The date and signature of the applicant.
(v) The name and address of the proposed marihuana facility.
(vi) The license type of the proposed marihuana facility.
(vii) Attestation that the applicant will report changes that occur with municipal ordinances or zoning regulations that relate to the proposed marihuana facility, municipal facility approvals, or violations of a municipal or zoning regulation.
(c) For an applicant seeking licensure under the MRTMA, confirmation of municipal compliance on an attestation form provided by the agency that includes all of the following:
(i) The name and address of the proposed marihuana establishment.
(ii) The license type of the proposed marihuana establishment.
(iii) The municipality where the proposed marihuana establishment is located.
(iv) The contact information for the municipality, including, at a minimum, all of the following:
(A) The name of the clerk of the municipality or the clerk’s designee.
(B) The telephone number of the clerk of the municipality or the clerk’s designee.
(C) The email address of the clerk of the municipality or the clerk’s designee.
(D) The mailing address of the clerk of the municipality or the clerk’s designee.
(v) Confirmation that the municipality has not adopted an ordinance prohibiting the proposed marihuana establishment.
(vi) Confirmation that the applicant is in compliance with ordinances the municipality has adopted relating to marihuana establishments within its jurisdiction, including zoning regulations.
(vii) Attestation that the applicant will report changes that occur with municipal ordinances or zoning regulations that relate to the proposed marihuana establishment, municipal establishment approvals, or violations of a municipal or zoning regulation.
(viii) The date and signature of the applicant.
(d) If the applicant is a producer, class A marihuana microbusiness, or microbusiness, which processing activities the applicant intends to perform.
(2) An applicant seeking licensure under the MRTMA shall provide an attestation acknowledging that the applicant shall have a physical structure for the marihuana establishment and pass the prelicensure inspection within 60 days after submitting a complete application to the agency. Failure to pass the prelicensure inspection within 60 days after submitting the complete application to the agency may result in the application being denied under R 420.11.
R 420.7 Application; fees;
assessment Proof of financial responsibility; insurance.
Rule 7. (1) At the beginning
of each state fiscal year, the agency may increase the fees collected under the
MRTMA by 10% in order to pay for implementation, administration, and
enforcement of that act and these rules.
(2) An applicant for a
marihuana license shall submit an application that is accompanied by the
nonrefundable application fee of $3,000.
(3) If the costs of the
investigation and processing the application exceed the application fee, the
applicant shall pay the additional amount.
(4) Additional fees for
state licenses under MRTMA are listed in table 1:
TABLE 1
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(5) The agency shall
establish and publish annually the regulatory assessment for licensees under
the MMFLA pursuant to section 603 of the MMFLA, MCL 333.27603.
(6) An applicant shall pay
the initial licensure fees or regulatory assessment, if applicable, on or
before the date the licensee begins operating and the renewal fee annually
thereafter, pursuant to these rules.
(7) The agency shall not
issue a marihuana license until a complete application is submitted, the fees
required under these rules are paid, and the agency determines that the
applicant is qualified to receive a marihuana license under the acts and these
rules. An applicant under the MRTMA must pay initial licensure fees within 10
calendar days of approval of the marihuana license or within 90 calendar days
of submitting a complete application, whichever date is first. An applicant
under the MMFLA must pay initial licensure fees within 10 calendar days of
approval of the marihuana license. An applicant must pay renewal fees upon
submission of the application for renewal. Failure to pay the required fee may
be grounds for the denial of a marihuana license in accordance with R 420.12.
(1) Before a marihuana license is issued or renewed, the applicant or licensee
shall file a proof of financial responsibility for liability for bodily injury
to lawful users resulting from the manufacture, distribution, transportation,
or sale of adulterated marihuana or adulterated marihuana-infused products on
the form prescribed by the agency for an amount not less than $100,000.00.
(2) The proof required in subrule (1) of this rule must be an insurance policy and the insured person must be the licensee.
(3) In addition to the requirements in subrule (1) of this rule, a marihuana transporter shall provide all of the following for each vehicle that is used to transport marihuana:
(a) Proof of auto insurance.
(b) A copy of the vehicle registration.
(c) Proof that the vehicle is registered as a commercial motor vehicle.
(4) An applicant for a marihuana event organizer license under the MRTMA is not required to provide the proof of financial responsibility for liability for bodily injury required under subrule (1) of this rule. A marihuana event organizer shall submit a proof of financial responsibility for liability for bodily injury when applying for a temporary marihuana event license or proof that each marihuana microbusiness, class A marihuana microbusiness, and marihuana retailer participating in the temporary marihuana event has coverage for liability for bodily injury when applying for a temporary marihuana event license.
(5) In addition to the proof of financial responsibility requirements in subrule (1) of this rule, an applicant or licensee under the MMFLA shall also carry commercial general liability insurance covering premises liability for an amount not less than $100,000.00. The applicant or licensee shall submit proof of commercial general liability insurance covering the premises liability to the agency not later than 60 days after the agency issues or renews a state operating license.
(6) In addition to the proof of financial responsibility requirements in subrule (1) of this rule, an applicant or licensee under the MRTMA shall also carry $50,000.00 in liability insurance under section 11a of the MRTMA, MCL 333.27961a. An applicant or licensee shall provide proof that the licensee carries marihuana liability insurance by submitting the full insurance policy to the agency in a manner prescribed by the agency. The applicant or licensee shall submit proof of the insurance required under this subrule not later than 60 days after a marihuana license is issued or renewed.
R 420.8 Marihuana business location plan.
Rule 8. (1) An applicant
shall submit a marihuana business location plan for the proposed marihuana
business as required in these rules and upon request by the agency. Upon the
request of the agency, an applicant or licensee may be required to submit a
revised marihuana business location plan.
(2) TheA
marihuana business location plan must include, at a minimum, all of the
following:
(a) The type of proposed
marihuana businesslicense for which the applicant is submitting an
application,.
(b) tThe
location of the proposed marihuana business, a description ofincluding
the address and the name of the municipality where the proposed
marihuana business will be located,. and
(c) anyAll
of the following, if applicable:
(i) A statement that a
combination of marihuana licenses will operate as separate marihuana businesses
at the same location, as provided under these rulesin R 420.203.
(ii) A statement in the
marihuana business location plan that the applicant has applied or
intends to apply to stack a marihuana license at the proposed marihuana
business as provided under these rulesin R 420.17.
(iii) For an applicant
seeking licensure under the MRTMA, aA statement that equivalent
licenses will operate at the same location.
(bd) A diagram
of the proposed marihuana business that includes, at a minimum, all of
the following:
(i) The proposed marihuana
business’s size and dimensionsnumber of rooms.
(ii) Specifications of the
marihuana businessDimensions of the proposed marihuana business,
including dimensions of interior rooms and exterior areas.
(iii) Physical address.
(iviii)
Locations of common entryways,entrances, exits, doorways,
and passageways.
(v) Public entries and
exits.
(viiv) Locations
of Llimited-access areas, and restricted
access areasincluding entrances, exists, doorways, and passageways to or
from the limited-access areas.
(v) Locations of dividing structures and fire walls.
(vi) Locations of storage areas and an indication of the maximum storage capacity of the storage areas.
(vii) Locations where hazardous materials are stored.
(viiviii) An
indicationLocations of the distinct areas or structures for separate
marihuana businesses operating at the same location as provided in
these rules¸if applicable.
(viiiix) If
the proposed marihuana business is a marihuana sales location, Aareas
designated for contactless and limited contact transactions, if the
marihuana business is a marihuana sales location.
(x) If the proposed marihuana business is a designated consumption establishment, all of the following:
(A) Locations of areas designated for the consumption of marihuana.
(B) Locations of smoke-free areas that are physically separated from areas designated for consumption.
(C) A ventilation system that directs air from the marihuana consumption area to the outside of the building through a filtration system sufficient to remove visible smoke, consistent with all applicable building codes and ordinances, and adequate to eliminate odor at the property line, if consumption by inhalation is allowed.
(c) A detailed floor plan
and layout that includes, at a minimum, all of the following:
(i) Dimensions of the
marihuana business including interior and exterior rooms.
(ii) Maximum storage
capabilities.
(iii) Number of rooms.
(iv) Dividing structures.
(v) Fire walls.
(vi) Entrances and exits.
(vii) Locations of
hazardous material storage.
(viiie) The
expected Qquantities and daily consumption of
hazardous materials, such aschemicals, and flammable/
or combustible liquids and gases, and the expected daily consumption
of the hazardous materialsat the proposed marihuana business.
(df) Means of
egress, including, but not limited to, delivery and transfer points.
(eg)
Construction details for structures and fire-rated construction for required
walls.
(fh) Building
structure information, including, but not limited to, new, pre-existing,
freestanding, or fixed.
(gi) Building
type information, including, but not limited to, commercial, warehouse,
industrial, retail, converted property, house, mercantile building, pole barn,
greenhouse, laboratory, or center.
(hj) Zoning
classification and zoning information.
(ik) IfWhether
the proposed marihuana business is in a locationbuilding that
contains multiple tenants. and
(l) any applicable Applicable
occupancy restrictions.
(jm) A
proposed security plan that demonstrates the proposed marihuana business
meets the security requirements specified in these rulesin R 420.209.
(kn) Any
otherOther information required by the agency if not
inconsistent with the acts and these rules.
(3) Any changes Changes
or modifications to the marihuana business location plan under this rule
must be reported to the agency and may require preapproval by the agency.
(4) On request of the agency, an applicant or licensee shall submit a revised marihuana business location plan.
(45) The agency
may provide a copy of the marihuana business location plan to the BFS, local
fire department, Michigan state police, local law enforcement, and
building officials for use in review and planning.
(56) The agency
may reinspect the marihuana business to verify compliance with the marihuana
business location plan at any time during the business’s hours of
operation and may require that the plan be resubmitted upon renewal.
R 420.8a Prelicensure inspections.
Rule 8a. (1) An applicant for a marihuana license shall submit to and pass a prelicensure inspection of the applicant’s proposed marihuana business to verify the accuracy of the marihuana business location plan and that the proposed marihuana business meets the requirements of the acts and these rules.
(2) An applicant for a marihuana license shall submit to and pass a prelicensure fire safety inspection of the applicant’s proposed marihuana business by the BFS to verify that the proposed marihuana business meets the requirements of NFPA standard 1 and NFPA standard 58 and the requirements of R 420.210.
R 420.9 Rescinded.
License fees; regulatory assessments; renewal fees.
Rule 9. (1) License fees for state licenses issued under the MRTMA are listed in table 1:
TABLE 1
State License Type |
Initial Licensure and Renewal Fees |
Class A Marihuana Grower |
$1,200.00 |
Class B Marihuana Grower |
$6,000.00 |
Class C Marihuana Grower |
$24,000.00 |
Designated Consumption Establishment |
$1,000.00 |
Excess Marihuana Grower* |
$24,000.00 |
Marihuana Event Organizer |
$1,000.00 |
Marihuana Microbusiness |
$8,300.00 |
Class A Marihuana Microbusiness |
$18,600.00 |
Marihuana Processor |
$24,000.00 |
Marihuana Retailer |
$15,000.00 |
Marihuana Safety Compliance Facility |
$15,000.00 |
Marihuana Secure Transporter |
$15,000.00 |
Temporary Marihuana Event |
See R 420.105 |
Marihuana Educational Research |
Not applicable |
* The fee for an excess marihuana grower is a renewal fee only.
(2) The agency shall establish and publish annually the regulatory assessment for licensees under the MMFLA under section 603 of the MMFLA, MCL 333.27603.
(3) An applicant for a state operating license shall pay the regulatory assessment within 10 days after the agency determines the applicant meets all the requirements for a state operating license.
(4) An applicant for a state license shall pay the initial licensure fee by whichever of the following dates comes first:
(a) Within 10 days after the agency determines the applicant meets all requirements for a state license.
(b) Within 90 days after submitting a complete application.
(5) A licensee shall pay a renewal fee annually, on or before the date the licensee’s marihuana license expires.
(6) At the beginning of each state fiscal year, the agency may increase the fees collected under the MRTMA by 10% to pay for implementation, administration, and enforcement of the MRTMA and these rules.
R 420.10 Proof of financial
responsibility; insurance Amendments; requirements.
Rule 10. (1) Before a
marihuana license is issued or renewed, the licensee or renewal applicant shall
file a proof of financial responsibility for liability for bodily injury to
lawful users resulting from the manufacture, distribution, transportation, or
sale of adulterated marihuana or adulterated marihuana-infused products on the
form prescribed by the agency, for an amount not less than $100,000.00. If the
proof required in this subrule is a bond, the bond must be in a format
acceptable to the agency.
(2) In addition to the
requirements in subrule (1) of this rule, a marihuana transporter shall show
proof of auto insurance, vehicle registration, and registration as a commercial
motor vehicle, as applicable, for any vehicles used to transport marihuana
product as required by the acts and these rules.
(3) For an applicant seeking
licensure for a marihuana event organizer license under the MRTMA, proof of
financial responsibility for liability for bodily injury is not required. A
marihuana event organizer licensee shall file a proof of financial
responsibility for liability for bodily injury when applying for a temporary
marihuana event license or proof that each marihuana microbusiness, class A
marihuana microbusiness, and marihuana retailer participating in the temporary
marihuana event has coverage for liability for bodily injury when applying for
a temporary marihuana event license.
(4) In addition to the
proof of financial responsibility requirements contained in subrule (1) of this
rule, a renewal applicant or licensee holding a license under the MMFLA shall
also carry commercial general liability insurance covering premises liability
for an amount not less than $100,000.00. An applicant shall provide proof of
commercial general liability insurance covering the premises liability to the
agency no later than 60 days after a state operating license is issued or
renewed. (1) A person may submit an amendment request in a manner
prescribed by the agency and shall submit all of the following:
(a) An amendment application.
(b) Information, records, documents, disclosures, attestations, interviews, reports, statements, memoranda, or data required by the agency that are not inconsistent with the acts or these rules.
(2) A person submitting an amendment request shall answer each question on the amendment application in its entirety.
(3) After an amendment request is submitted, the agency may request additional information, records, documents, disclosures, attestations, interviews, reports, statements, memoranda, or data necessary to determine if the amendment application should be approved. An applicant or licensee shall submit information requested under this subrule within 5 days.
(4) The agency may administratively withdraw an amendment request for either of the following reasons:
(a) If the applicant or licensee is sent a notice of deficiency and fails to submit required documentation within 30 days after the notice is sent.
(b) If the person submits an amendment request and the person has disciplinary action pending. A person whose amendment request is withdrawn under this subdivision may submit a new request after the pending disciplinary action is resolved.
R 420.11 Capitalization
requirements; medical marihuana facilities licensing act Denial of a
marihuana license; additional reasons.
Rule 11. (1) An applicant for
initial licensure under the medical marihuana facilities licensing act shall
disclose the sources and total amount of capitalization to operate and maintain
a proposed marihuana facility.
(2) The total amounts of
capitalization based on the type of marihuana facility specified in the
application for a state operating license are as follows:
(a) Grower - Class A:
$150,000.00.
(b) Grower - Class B:
$300,000.00.
(c) Grower - Class C:
$500,000.00.
(d) Processor: $300,000.00.
(e) Provisioning Center:
$300,000.00.
(f) Secure Transporter:
$200,000.00.
(g) Safety Compliance
Facility: $200,000.00.
(3) An applicant under the
MMFLA shall provide proof to the agency of the capitalization amounts specified
in subrule (2)(a) to (g) of this rule from both of the following sources:
(a) Not less than 25% is in
liquid assets to cover the initial expenses of operating and maintaining the
proposed marihuana facility, as specified in the application. As used in this
subdivision, "liquid assets" include assets easily convertible to
cash, including, but not limited to, cash, certificates of deposit, 401(k)
plans, stocks, and bonds.
(b) Proof of the remaining
capitalization to cover the initial expenses of operating and maintaining the
proposed marihuana facility may include, but is not limited to, additional
liquid assets as described in subdivision (a) of this subrule or equity in real
property, supplies, equipment, fixtures, or any other nonliquid asset.
(4) The applicant shall
provide proof that there is no lien or encumbrance, except for a mortgage
encumbering the real property, on the asset provided as a source of
capitalization. For purposes of this subrule, if the encumbrance is a mortgage
on the real property then the applicant shall disclose the value of the equity
of the real property less any mortgage.
(5) The capitalization
amounts and sources must be validated by Certified Public Accountant (CPA)
attested financial statements. The applicant shall disclose any of the
capitalization sources that are foreign and a foreign CPA or its equivalent
shall attest to the validation, and a domestic CPA shall attest to that foreign
validation. In addition to the reasons for denial under the acts, the
agency may deny an application for prequalification or a marihuana license for any
of the following reasons:
(a) The applicant submitted an application that contains a material misrepresentation or false information.
(b) The applicant failed to notify the agency in a timely manner that information provided to the agency as part of the application changed after the application was submitted.
(c) The applicant failed to correct a deficiency within 5 days after notification by the agency.
(d) The applicant meets 1 of the following:
(i) Holds an elective office of a governmental unit of this state, another state, or the federal government.
(ii) Is a member of or employed by a regulatory body of a governmental unit in this state, another state, or the federal government.
(iii) Is employed by a governmental unit of this state.
(e) Subdivision (d) of this subrule does not apply to any of the following:
(i) An elected officer of or employee of a federally recognized Indian tribe.
(ii) An elected precinct delegate.
(iii) The spouse of a person who applies for a state license unless the spouse’s position creates a conflict of interest or is within any of the following:
(A) The agency.
(B) A regulatory body of a governmental unit in this state, another state, or the federal government that makes decisions regarding adult-use marijuana.
(f) The applicant has engaged in activities for which a marihuana license is required under the MMFLA or MRTMA without a marihuana license.
(g) The applicant has been served with a complaint or other notice filed with a public body that payment of a tax required under federal, state, or local law has been delinquent for 1 or more years.
(h) The applicant has been convicted of a crime involving dishonesty, theft, or fraud that indicates the proposed marihuana business is unlikely to be operated with honesty and integrity.
(i) A civil judgment has been entered against the applicant for failure to pay for work, services, products, or equipment provided to the applicant. The work, services, products, or equipment must be directly related to participation in the marihuana industry.
(j) The applicant has a history of regulatory noncompliance with a municipal, state, or federal regulatory body.
(k) The applicant has a criminal or regulatory history that includes distribution of tobacco or alcohol to a minor.
(l) The applicant is a licensee or managerial employee for a license type that conflicts with the license type for which the applicant applied. As used in this subdivision, license types that conflict are those licenses described in section 9 of the MRTMA, MCL 333.27959.
(m) The applicant is seeking licensure under the MRTMA, for either of the following:
(i) The applicant holds a state operating license under the MMFLA and has failed to file or is delinquent in the payment of the sales tax required under the General Sales Tax Act, 1933 PA 167, MCL 205.51 to 205.78, or the excise tax required under section 601 of the MMFLA, MCL 333.27601.
(ii) The applicant holds a state license under the MRTMA and has failed to file or is delinquent in the payment of the sales tax required under the General Sales Tax Act, 1933 PA 167, MCL 205.51 to 205.78, or the excise tax required under section 13 of the MRTMA, MCL 333.27963.
R 420.11a Prelicensure
investigation; proposed marihuana business inspection. Rescinded.
Rule 11a. (1) An applicant
for a marihuana license shall submit to and pass a prelicensure physical
inspection of a proposed marihuana business, prior to licensure, as determined
by the agency.
(2) The agency shall
establish an inspection process to confirm that the applicants and proposed
marihuana businesses meet the requirements of the acts and these rules.
(3) The agency shall
investigate an applicant pursuant to the acts and these rules.
(4) The agency, through its
investigators, agents, auditors, or the state police shall conduct inspections
and examinations of an applicant and a proposed marihuana business pursuant to
the acts and these rules.
(5) An applicant shall
submit to the agency proof of both of the following:
(a) A certificate of use
and occupancy as required pursuant to section 13 of the Stille-DeRossett-Hale
single state construction code act, 1972 PA 230, MCL 125.1513, and these rules.
If this certificate is not available, the agency may accept alternative
documentation from the building authority. The requirement of this subrule is
not applicable to temporary marihuana event applicants.
(b) If applicable, a fire
safety inspection as specified in these rules.
R 420.12 Denial of a marihuana
license; additional reasons Denial of an amendment.
Rule 12. (1) The agency may
deny a license if an applicant fails to comply with the applicable act or these
rules.
(2) In addition to the
reasons for denial in the acts, the agency may deny a marihuana license for the
following reasons:
(a) The applicant’s
marihuana business location plan does not fully comply with the acts or these
rules.
(b) The applicant’s
proposed marihuana business or marihuana business is substantially different
from the marihuana business location plan pursuant to R 420.8 and these rules.
(c) The agency is unable to
access the proposed marihuana business for prelicensure agency inspection or
the applicant denied the agency access to the proposed marihuana business.
(d) The applicant made a
material misrepresentation on the application.
(e) The applicant failed
to correct a deficiency within 5 days of notification by the agency in
accordance with the acts and these rules.
(f) The applicant failed to
provide confirmation of municipal compliance as required under R 420.5(1)(d) or
(e).
(g) The applicant’s
proposed marihuana establishment is in a municipality that has adopted an
ordinance prohibiting marihuana establishments or the proposed marihuana
establishment does not comply with an ordinance consistent with section 6 of
the MRTMA, MCL 333.27956.
(h) The applicant is
operating or was operating a proposed marihuana business without a marihuana
license.
(i) The applicant has
knowingly submitted an application containing false information.
(j) The applicant has
failed to pay required fees pursuant to these rules.
(k) The applicant has
failed to comply with these rules and the application requirements pursuant to
these rules.
(l) The applicant has been
delinquent with the payment of taxes required under federal, state, or local
law for 1 or more years.
(m) The applicant fails to
provide notifications or reports to the agency pursuant to these rules.
(n) The applicant or anyone
meeting the definition of applicant has a pattern of convictions involving
dishonesty, theft, or fraud that indicate the proposed marihuana business is
unlikely to be operated with honesty and integrity.
(o) For an applicant
seeking licensure under the MRTMA, the applicant failed a prelicensure
inspection within 60 days of submitting a complete application to the agency.
(p) For an applicant
seeking licensure under the MRTMA, the applicant or anyone meeting the
definition of applicant has a conviction involving distribution of a controlled
substance to a minor pursuant to section 8 of the MRTMA, MCL 333.27958.
(q) For an applicant
seeking licensure under the MRTMA, the applicant holds a state operating
license under the MMFLA and has failed to file or is delinquent in the payment
of the sales tax required under the General Sales Tax Act, 1933 PA 167, MCL
205.51 to 205.78, or the excise tax required under section 601 of the MMFLA,
MCL 333.27601.
(r) For an applicant
seeking licensure under the MRTMA, the applicant holds a state license and has
failed to file or is delinquent in the payment of the sales tax required under
the General Sales Tax Act, 1933 PA 167, MCL 205.51 to 205.78, or the excise tax
required under section 13 of the MRTMA, MCL 333.27963.
(s) The applicant failed to
pass the prelicensure inspection required under R 420.11a.
(t) The applicant or
licensee has filed an amendment to the application for a marihuana license
seeking to add an individual or entity to the application or license that is
not eligible or suitable for licensure, or the amendment is not eligible for
licensure as it fails to comply with the acts and these rules.
(u) The applicant or
licensee was previously required to file an annual financial statement under
the MMFLA and these rules and failed to file the annual financial statement.
(1) The agency may deny an amendment request for any of the following
reasons:
(a) The requested amendment would violate the requirements for prequalification prescribed in the acts or this part of these rules.
(b) The requested amendment would violate the requirements for licensure prescribed in the acts or this part of these rules.
(c) The licensee acted on or implemented the proposed amendment before receiving agency approval.
(d) The requested amendment would violate another provision of the acts or these rules.
(2) If the agency denies an amendment request, the person that submitted the request may request a hearing under part 9 of these rules.
(3) If the person does not request a hearing in writing within 21 days after the agency denies the request, the denial becomes the final order of the agency.
R 420.13 Renewal of a marihuana license.
Rule 13. (1) A marihuana
license is issued for a 1-year period and is renewable annually. A licensee
shallmay apply to renew a marihuana license on a form
establishedin a manner prescribed by the agency. and shall
submit all of the following: The licensee shall pay the required fee
upon submission of the application for renewal. The marihuana license may be
renewed no more than 90 calendar days before the expiration of the marihuana
license, if the licensee has submitted the renewal form required by the agency
and, if applicable, the licensee has paid any additional background
investigation charge assessed by the agency under these rules. The applicant
shall include on the renewal form, a statement requesting renewal of the
marihuana license and all of the following information:
(a) A renewal application that includes all of the following:
(i) The legal name and address of the marihuana business.
(ii) The municipality where the marihuana business is located.
(iii) The license number of the marihuana business.
(iv) To the extent
that information has changed or not been previously reported to the agency,
updated personal, business, and financial information, as the agency may
require, related to the eligibility qualification, and suitability of
the licensee to continue to hold the marihuana license for which renewal is
requested under the acts and these rules. For a licensee seeking renewal
under the MMFLA, required information may also be related to the business
probity; financial ability and experience; and responsibility or means to
operate or maintain a marihuana facility of the licensee and each person
required to be qualified for renewal of the license under the MMFLA. To the
extent that the information has changed or has not been previously reported,
updated information on the marihuana business is required.
(v) The licensee’s current organizational structure.
(vi) Brands produced by the licensee, if applicable.
(b) (vii)
An statement under oathattestation by the licensee that all
of the following are true:
(A) tThe
information provided in the licensee’s annual renewal formapplication
is current, complete, true, and accurate,. and that
(B) tThe
licensee has fulfilled itstheir obligation under the acts and
these rules to notify the agency of any a change in information
provided in its the licensee’s original marihuana license application
and subsequent annual renewal form or formsapplication or
applications previously filed, if applicable.
(C) The licensee’s renewal application provides all information and documentation required by the agency to establish that the licensee is eligible, qualified, and suitable to have their marihuana license renewed.
(cb) For an
applicanta licensee seeking renewal of a license under the MMFLA, all
of the following:
(i) To the extent that information has changed or not been previously reported to the agency, information related to the business probity, financial ability, and experience, and responsibility or means to operate or maintain a marihuana facility of the licensee and each person required to be qualified for renewal of the license under the MMFLA.
(ii) cConfirmation
of municipal compliance on an attestation form provided by the agency that includes
all of the following:
(i)(A) A
description of anya violation of an ordinance or a zoning
regulation adopted pursuant to under section 205 of the MMFLA,
MCL 333.27205, committed by the licensee, if applicable, but only
if the violation relates to activities licensed under the acts or these
rules.
(ii)(B) Whether
there has been a change to an ordinance or a zoning regulation adopted pursuant
to under section 205 of the MMFLA, MCL 333.27205, since the
marihuana license was issued to the licensee and a description of the change.
(iii)(C) The
date and signature of the clerk of the municipality or his or herthe
clerk’s designee.
(iv)(D) The
date and signature of the applicantlicensee.
(v) The name and address
of the marihuana facility.
(vi) The license type of
the marihuana facility.
(dc) For an
applicanta licensee seeking renewal of a license under the MRTMA, all
of the following:
(i) cConfirmation
of municipal compliance on an attestation form provided by the agency that
includes all of the following:
(i)(A) A
description of any violation, if applicable, of an ordinance or
a zoning regulation consistent with section 6 of the MRTMA, MCL 333.27956,
committed by the licensee, if applicable, but only if the violation
relates to activities licensed under the act or these rules.
(ii)(B) Whether
there has been a change to an ordinance or a zoning regulation consistent with
section 6 of the MRTMA, MCL 333.27956, since the marihuana license was issued
to the licensee and a description of the change.
(iii)(C) The
following information for the municipality where the marihuana establishment is
located, including, at a minimum, all of the following:
(A) The name and address
of the marihuana establishment.
(B) The license type of
the marihuana establishment.
(C) The municipality
where the marihuana establishment is located.
(D) The contact
information for the municipality, including, at a minimum, all of the
following:
(I) The name of the clerk
of the municipality or his or her the clerk’s designee.
(II) The telephone number
of the clerk of the municipality or his or her the clerk’s designee.
(III) The email address of
the clerk of the municipality or his or her the clerk’s designee.
(IV) The mailing address of
the clerk of the municipality or his or her the clerk’s designee.
(ivii)
Confirmation that the municipality has not adopted an ordinance prohibiting the
proposed marihuana establishment.
(viii)
Confirmation that the applicantlicensee is in compliance with any
ordinanceordinances the municipality has adopted relating to
marihuana establishments within its jurisdiction, including zoning regulations.
(viiv) An Aattestation
that the applicantlicensee will report any changes that
occur with municipal ordinances or zoning regulations that relate to the
marihuana establishment, any municipal establishment approvals, or any
violations of a municipal or zoning regulation.
(vii) The date and
signature of the applicantlicensee.
(d) A renewal fee described in R 420.9.
(e) An attestation by the
licensee that the licensee’s annual renewal form provides all information and
documentation required by the agency to establish that the licensee is
eligible, qualified, and suitable to have its marihuana license renewed and is
ready and able to continue conducting its marihuana business in compliance with
the acts and these rules throughout the new 1-year time period for which the
license is to be renewed.In addition to the requirements under
subdivisions (a) to (d) of this subrule, other information, records, documents,
disclosures, attestations, interviews, reports, statements, memoranda, or data
required by the agency that are not inconsistent with the acts or these rules.
(f) Other relevant
information and documentation that the agency may require to determine the
licensee’s eligibility to have its marihuana license renewed under the
licensing standards of the acts and these rules.
(2) Failure to comply with
any of the provisions of the acts and these rules may result in the nonrenewal
of a marihuana license. The agency shall not renew a marihuana license unless
the agency determines, as part of the license renewal, that each person
required by the acts and these rules to meet licensing standards is eligible,
qualified, and suitable under the relevant licensing standards.
(3) The licensee shall meet
the requirements of the acts and any other renewal requirements set forth in
these rules.
(4) The agency may refuse to
renew a marihuana license and issue a notice of nonrenewal if the licensee
fails to apply for renewal in accordance with section 402 of the MMFLA, MCL
333.27402, as applicable, and this rule. In addition, the agency may refuse to
renew a marihuana license and issue a notice of nonrenewal if the agency
determines, after reviewing the licensee’s annual renewal form, that the
marihuana license should not be renewed because the licensee’s annual renewal
form does not provide the information and documentation required by the agency
to determine that the licensee is eligible, qualified, and suitable to continue
to be licensed and ready and able to continue conducting its marihuana business
in compliance with the acts and these rules.
(5) The agency may refuse to
renew a marihuana license and issue a notice of nonrenewal if the licensee has
failed to submit an annual financial statement required under the acts and
these rules for the marihuana license it is renewing or for a previously held
marihuana license.
(6) If a license renewal
application for a license under the MMFLA is not submitted by the license
expiration date, the license may be renewed within 60 days after its expiration
date upon submission of the required application, payment of the
required fees, and satisfaction of any renewal requirements. The
licensee may continue to operate during the 60 calendar days after the license
expiration date if the licensee submits the renewal application to the agency
and complies with the other requirements for renewal.
(73) The agency
shall send a renewal notice to the last known address of a licensee on file
with the agency. The failure of a licensee to notify the agency of a change of
address does not extend the expiration date of a license and may result in disciplinary
action.
(8) A marihuana licensee who
is served with a notice of nonrenewal may request a hearing pursuant to these
rules.
(9) If the licensee does not
request a hearing in writing within 21 calendar days after service of the
notice of nonrenewal, the notice of nonrenewal becomes the final order of the
agency.
(10) A person who has not
applied for marihuana license renewal for any and all licenses that are due for
renewal shall cease and desist operation and is subject to any sanctions or
fines, or both, pursuant to the acts and these rules.
(4) A marihuana license may be renewed no more than 90 days before the expiration of the marihuana license, if the licensee has submitted the renewal form required by the agency and, if applicable, the licensee has paid an additional background investigation charge assessed by the agency under these rules.
(5) Except as provided in subrule (2) of this rule, if a licensee does not apply to renew a marihuana license, the marihuana business for which the license was not renewed shall cease and desist operations when the marihuana license expires.
R 420.14 Notification and
reportingNonrenewal of a marihuana license.
Rule 14. (1) Applicants have
a continuing duty to provide the agency with up-to-date contact information and
shall notify the agency in writing of any changes to the mailing addresses,
phone numbers, electronic mail addresses, and other contact information they
provide the agency.
(2) Applicants shall report
to the agency any changes to the marihuana business operations that are
required in the acts and these rules, as applicable.
(3) Applicants shall report
to the agency any proposed material changes to the marihuana business before
making a material change. Material changes include, at a minimum, the
following:
(a) Change in owners,
officers, members, or managers.
(b) Change of processing
machinery or equipment.
(c) The addition or removal
of persons named in the application or disclosed.
(d) Change in entity name.
(e) Any attempted transfer,
sale, or conveyance of an interest in a marihuana license.
(f) Any change or
modification to the marihuana business before or after licensure that was not
preinspected, inspected, or part of the marihuana business location plan or
final inspection including, at a minimum, all of the following:
(i) Operational or method
changes requiring inspection under these rules.
(ii) Additions or
reductions in equipment or processes at a marihuana business.
(iii) Increase or decrease
in the size or capacity of the marihuana business.
(iv) Alterations of ingress
or egress.
(v) Changes that impact
security, fire safety, and building safety.
(4) An applicant shall
notify the agency within 3 business days of becoming aware of or within 3
business days of when the applicant should have been aware of any of the
following:
(a) Criminal convictions,
charges, or civil judgments against an applicant in this state or any other
state, federal, or foreign jurisdiction.
(b) Disciplinary action
taken against an applicant by this state or any other state, federal, or
foreign jurisdiction, including any pending action.
(5) The applicant shall
notify the agency within 10 calendar days of the initiation or conclusion of
any new judgments, lawsuits, legal proceedings, charges, or government
investigations, whether initiated, pending, or concluded, that involve the
applicant.
(6) The applicant shall
notify the agency within 10 calendar days of receiving notification of an
alleged violation of an ordinance or a zoning regulation adopted pursuant to
section 205 of the MMFLA, MCL 333.27205, or section 6 of the MRTMA, MCL
333.27956, committed by the applicant, but only if the violation relates to
activities licensed under the acts, the Michigan Medical Marihuana Act, and
these rules.
(7) The applicant shall
notify the agency and the BFS within 1 business day following the occurrence of
an unwanted fire.
(8) The licensee shall
notify the agency within 10 business days of the appointment of a
court-appointed personal representative, guardian, conservator, receiver, or trustee
of the licensee.
(9) Failure to provide
notifications or reports to the agency pursuant to this rule may result in
sanctions or fines, or both. (1) The agency shall not renew a
marihuana license unless the agency determines, as part of the license renewal,
that each person required by the acts and these rules to meet licensing
standards is eligible, qualified, and suitable under the relevant licensing
standards.
(2) The agency may refuse to renew a marihuana license for any of the following:
(a) The reasons for denial of a marihuana license in R 420.11.
(b) The licensee fails to apply for renewal as required in R 420.13.
(c) The agency determines, after reviewing the licensee’s renewal application, that the marihuana license should not be renewed because the licensee’s renewal application does not provide the information and documentation required by the agency to determine that the licensee is eligible, qualified, and suitable to continue to be licensed and ready and able to continue conducting its marihuana business in compliance with the acts and these rules.
(d) The licensee has failed to submit an annual financial statement required under the acts and these rules for the marihuana license it is renewing or for another marihuana license currently or previously held by the licensee.
(e) The licensee has failed to comply with the provisions of the acts or these rules.
(3) A marihuana licensee that is served with a notice of nonrenewal may request a hearing under part 9 of these rules.
(4) If the licensee does not request a hearing in writing within 21 days after service of the notice of nonrenewal, the notice of nonrenewal becomes the final order of the agency.
R 420.15 Notifications of
diversion, theft, loss, or criminal activity Notification and reporting.
Rule 15. (1) Applicants shall
notify the agency and local law enforcement authorities within 24 hours of
becoming aware of or within 24 hours of when the applicant should have been
aware of the theft or loss of any marihuana product or criminal activity at the
marihuana business.
(2) Failure to notify as
required under subrule (1) of this rule may result in sanctions or fines, or
both. (1) A licensee has a continuing duty to provide the agency with
up-to-date contact information, including all of the following:
(a) The individual, or individuals, who are the authorized contact for the licensee. At least 1 individual under this division shall be a licensee, supplemental applicant, or managerial employee of the marihuana business.
(b) A mailing address.
(c) A phone number, electronic mail addresses, or other contact information required by the agency.
(2) A licensee shall notify the agency in writing within 10 days after changes to the contact information required in subrule (1) of this rule or the operations of the marihuana business that are required in the acts and these rules, as applicable.
(3) A licensee shall immediately notify the agency if the licensee becomes aware that both of the following circumstances exist:
(a) Any of the following circumstances pertaining to a marijuana product occurred:
(i) The product has been adulterated or contaminated.
(ii) The product has not passed full compliance testing.
(iii) The product was not tested in compliance with the requirements for testing in part 5 of these rules.
(iv) The product has been mislabeled.
(b) The product is currently available for sale or has already been sold to a marihuana customer.
(4) A licensee shall notify the agency and local law enforcement within 24 hours after becoming aware of, or within 24 hours after the licensee should have been aware of, the theft or loss of marihuana or criminal activity at the marihuana business.
(5) A licensee shall notify the agency and the BFS within 24 hours after the occurrence of an uncontrolled fire.
(6) A licensee shall notify the agency within 24 hours after becoming aware of, or within 24 hours after the licensee should have been aware of, adverse reactions to marihuana sold or transferred by the licensee.
(7) A licensee shall notify the agency within 5 days after becoming aware of, or within 5 days after the licensee should have been aware of, any of the following:
(a) Criminal convictions, charges, or civil judgments against a licensee in this state or another state, federal, or foreign jurisdiction.
(b) Disciplinary action taken against a licensee by this state or another state, federal, or foreign jurisdiction, including pending action.
(8) A licensee shall notify the agency within 10 days after any of the following:
(a) The initiation of lawsuits, legal proceedings, charges, or government investigations that involve the licensee.
(b) The conclusion of any lawsuits, legal proceedings, charges, or government investigations that involved the licensee.
(c) A judgment entered against the licensee.
(d) Receiving notification of an alleged violation of an ordinance or a zoning regulation adopted under section 205 of the MMFLA, MCL 333.27205, or section 6 of the MRTMA, MCL 333.27956, committed by the applicant, but only if the violation relates to activities licensed under the acts, the Michigan Medical Marihuana Act, and these rules.
(e) A change or modification of a lease, including changes in payment or waiving of rent, and updates made to the property by the landlord without being reimbursed.
(f) A change or modification of a deed or insurance policy.
(g) A new or pending tax liability or delinquency against the licensee by this state or another state, federal, or foreign jurisdiction.
(h) A notice of eviction against the licensee in this state or another state, federal, or foreign jurisdiction.
(9) A licensee shall notify the agency within 14 days after the appointment of a court-appointed personal representative, guardian, conservator, receiver, or trustee of the licensee.
(10) A notification or report submitted to the agency under this rule must be submitted in the manner prescribed by the agency for submitting the notification or report.
R 420.16 Inspection;
investigation Removing restrictions on ownership interests.
Rule 16. (1) The agency
shall do all of the following with respect to inspections and investigations of
applicants, licensees, proposed marihuana businesses, and marihuana business
operations:
(a) Oversee and conduct
inspections through its investigators, agents, auditors, or the state police of
proposed marihuana businesses and marihuana businesses to ensure compliance
with the acts and these rules.
(b) Inspect and examine
marihuana businesses and proposed marihuana businesses.
(c) Inspect, examine, and
audit records of the licensee.
(2) The agency may
investigate individuals employed by proposed marihuana businesses and marihuana
businesses.
(3) As authorized by the
acts, a licensee may not refuse the agency access to the marihuana business during
the hours of operation. The agency may access the marihuana business without a
warrant and without notice to the licensee during the marihuana business's
hours of operation.
(4) The agency may place an
administrative hold on a marihuana product and order that no sales or transfers
occur during an investigation for an alleged violation or violation of the acts
or these rules.
(5) The agency may inspect,
examine, and audit relevant records of the licensee. If a licensee fails to
cooperate with an investigation, the agency may impound, seize, assume physical
control of, or summarily remove records from a proposed marihuana business or
marihuana business as authorized under the acts and these rules.
(6) The agency may eject or
exclude, or authorize the ejection or exclusion of, an individual from a
proposed marihuana business or marihuana business if that individual violates
the acts, a final order, or these rules.
(7) The agency may take any
reasonable or appropriate action to enforce the acts and these rules.
(8) This rule does not limit
the application of any other remedies or sanctions that are available through
local, state, and federal laws, the acts, and these rules.
(9) As used in this rule,
“record” means books, ledgers, documents, writings, photocopies,
correspondence, electronic storage media, electronically stored records, money
receptacles, equipment in which records are stored, including data or
information in the statewide monitoring system, or any other document that is
used for recording information. Beginning on the effective date of this
rule, a person may hold an ownership interest in more than 5 marihuana growers
or more than 1 marihuana microbusiness.
R 420.17 Stacked license.
Rule 17. (1) A licensee holding amore
than 1 license as a class C grower under the medical marihuana
facilities licensing actMMFLA, or a class C marihuana
grower under the Michigan regulation and taxation of marihuana actMRTMA,
or both, may apply to stack class C licenses at a marihuana business
specified in the marihuana license applicationoperate under stacked
licenses at the marihuana business location of a single cultivator.
(2) A licensee shall not operate under stacked licenses until approved by the agency.
(3) TheA licensee
shall pay a separate initial licensure feelicense fees,
or regulatory assessmentassessments, and renewal fees, as
applicable, for each marihuana license issued and stacked and may be
subject to additional fees under these rulesgrower under the MMFLA and
marihuana grower under the MRTMA operating under the stacked licenses.
(2) A licensee that has been
issued stacked licenses is subject to all the requirements of the acts and
these rules.
R 420.18 Changes to licenseda
marihuana business.
Rule 18. (1) Any change or
modification to the marihuana business after licensure is governed by the
standards and procedures set forth in these rules and any regulations adopted
pursuant to the acts. Any material change or modification to the marihuana
business must be approved by the agency before the change or modification is
made.
(2) Any change of a location
of a marihuana business after licensure requires notification to the agency
prior to the change of location, must be approved by the agency, requires a new
marihuana license application under these rules, and may include, but is not
limited to, all of the following:
(a) Additional application
fees.
(b) Additional inspections
by the agency or BFS.
(c) Initial licensure fees
or regulatory assessment, as applicable, or both. (1) A licensee shall
not make a material change to a marihuana business unless the licensee submits
a request to make a material change and the agency approves the change.
(2) A material change includes, but is not limited to, any the following:
(a) Changes in owners, officers, members, directors, or managerial employees, or their spouses.
(b) The addition or removal of persons named or disclosed in the application.
(c) Changes to the name of the legal entity; the name under which the legal entity conducts business, if different from the entity name; or assumed name.
(d) Changes in business structure.
(e) Changes to trademarks, service marks, or brands used by the licensee.
(f) An attempted transfer, sale, or conveyance of an interest in a marihuana license.
(g) A change or modification to the marihuana business before or after licensure that was not inspected during a prelicensure inspection or inspection, or part of the marihuana business location plan or final inspection including, at a minimum, all of the following:
(i) Changes to operations, processes, or methods requiring inspection under these rules.
(ii) Additions or reductions in processing machinery or equipment.
(iii) An increase or decrease in the size or capacity of the marihuana business.
(iv) Alterations to the means of ingress or egress.
(v) Changes that impact security, fire safety, or building safety.
(3) A licensee shall not change the location of a marihuana business unless the licensee submits a new marihuana license application and receives approval from the agency. A new application may include, but is not limited to, all of the following:
(a) Additional application fees.
(b) Additional inspections by the agency or the BFS.
(c) Initial license fees or regulatory assessment, or both, as applicable.
R 420.19 Communities disproportionately impacted by marihuana prohibition.
Rule 19. (1) Pursuant toUnder
section 8(1)(j) of the MRTMA, MCL 333.27958, the agency shall
establish a plan that promotes and encourages participation in the marihuana
industry by people from communities that have been disproportionately impacted
by marihuana prohibition and enforcement and to positively impact those
communities.
(2) The agency shall publish all of the following information about the plan:
(a) The criteria used to select communities that have been disproportionately impacted by marihuana prohibition and enforcement.
(b) Based on the selection criteria, a list of the communities that have been disproportionately impacted by marihuana prohibition and enforcement.
(c) The requirements persons in those communities must meet to utilize services and resources offered through the plan.
(d) The services and resources that are available to those communities and qualifying persons residing in and planning to operate a marihuana establishment in those communities selected in subdivision (b) of this subrule.
(e) Specific goals and objectives for the plan.
(3) The agency shall collect data to measure its progress towards achieving the specific goals and objectives outlined in subrule (2)(e) of this rule.
(4) The agency shall publish a
list of services and resources offered through the plan, which must include,
but is not be limited to, all of the following:
(a) Education and outreach to the communities and potential applicants from the community.
(b) The waiver or reduction of fees for qualified applicants from the communities.
(c) Increased assistance with the application process for applicants from these communities.
(d) Coordination of
communities’, applicants’, and licensees’ utilization of resources that will
allow participation in the marihuana industry.
Rule 420.19a Social equity program.
Rule 19a. (1) An applicant or licensee may submit a request to participate in the social equity program created by the agency under section 8(1)(j) of the MRTMA, MCL 333.27958, in a form and manner prescribed by the agency.
(2) To participate in the social equity program, an applicant or licensee must meet at least 1 of the following conditions:
(a) Has resided in a community or communities listed under R 420.19(2)(b) for not less than 5 years.
(b) Except as provided in subrule (3) of this rule, has been convicted of a misdemeanor or felony marijuana-related offense.
(c) Has been a registered primary caregiver under the Michigan Medical Marijuana Act for not less than 3 years during the 5-year period immediately before the person’s request to participate in the social equity program.
(3) A person convicted of distributing a controlled substance to a minor is not eligible to participate in the social equity program under subrule (2)(b) of this rule.
(4) Initial participation in the social equity program is for a period of 2 years. A participant may renew their participation after the initial 2-year period and annually after the first renewal by submitting a renewal request in a manner prescribed by the agency.
(5) A participant that fails to submit a renewal request will be removed from the social equity program. An applicant or licensee that is removed from the program may submit a new request to participate in the program. A person that submits a request under this subrule shall submit a renewal request after a period of 1 year.
(6) Subject to subrule (7) of this rule, the agency shall reduce the fees paid by a social equity program participant by a percentage not to exceed 75% as follows:
(a) For a participant that is eligible under subrule (2)(a) of this rule, by 25%.
(b) For a participant that is eligible under subrule (2)(b) of this rule, by the greater of the following, as applicable:
(i) For a participant convicted of a misdemeanor marijuana-related offense, by 25%.
(ii) For a participant convicted of a felony marijuana-related offense, by 40%.
(c) For a participant that is eligible under subrule (2)(c) of this rule, by 10%.
(7) If a social equity program participant operates a marijuana establishment in a community not listed under R 420.19(2)(b), the fee reductions in subrule (6) of this rule apply to that establishment for 2 years after the date the license for the establishment was issued.
(8) A person that meets the requirements for participation in the social equity program that obtained prequalification status under part 2 of these rules and whose prequalification status has expired is not required to pay another application fee if the person submits a new prequalification application.
(9) A social equity program participant may apply for additional fee reductions by submitting a request in a manner prescribed by the agency.
(10) Fee reductions for which a social equity program participant is approved do not apply to fees that were assessed before the agency’s approval of the fee reductions.
R 420.20 Financial statements.
Rule 20. (1) Every 3 years,
or a shorter time as determined by the agency, Eacha licensee
under the MRTMA shall transmit to the agency complete financial
statements of the licensee’s total operations.
(2) A certified public
accountant shall review the Thefinancial statements shall be
reviewed by a certified public accountant in a manner and form
prescribed by the agency. The certified public accountant must be licensed in
this state under article 7 of the occupational code, 1980 PA 299, MCL 339.720
to 339.736. The compensation for the certified public accountant must be paid
directly by the licensee to the certified public accountant. The agency
shall issue an advisory bulletin to instruct licensees on the time and manner
in which to submit the financial statements. Financial statements must be
prepared so they include all required information for each license held by the
licensee.
(2) A marihuana educational
research licensee is not required to file an annual financial statement.
(3) If the agency identifies a deficiency in the financial statements or requires further information, the agency shall notify the licensee and the licensee shall submit the missing information or proof that the deficiency has been corrected to the agency within 5 days after the date the licensee received the deficiency notice.
(4) If a licensee fails to submit a required financial statement by the due date or fails to correct a deficiency or provide required information within 5 days after notification by the agency, the agency may do both of the following:
(a) Require the licensee to submit financial statements more frequently than every 3 years for a period of time determined by the agency.
(b) Impose a penalty under part 10 of these rules.
(5) The agency shall assign a licensee to a 3-year reporting cycle that is maintained throughout the licensee’s period of licensure, unless the reporting cycle is shortened as provided in subrule (4) of this rule.
(6) The agency shall assign a licensee to a reporting period and due date described in table 1.
TABLE 1
Reporting Period |
Financial Report Due Date |
January 1 to December 31 |
June 30 immediately after the end of the reporting period |
April 1 to March 31 |
September 30 immediately after the end of the reporting period |
July 1 to June 30 |
December 31 immediately after the end of the reporting period |
October 1 to September 30 |
March 31 immediately after the end of the reporting period |
(7) A licensee that is issued any of the following license types is not required to file a financial statement for that license:
(a) Marihuana educational research license.
(b) Marihuana event organizer license.
(c) Designated consumption establishment license.
PART 2. SPECIAL
LICENSES UNDER THE MICHIGAN REGULATION AND TAXATION OF MARIHUANA ACT
R 420.21 Special licenses;
eligibility Licensing, management, manufacturing, other agreements.
Rule 21. (1) A person may
apply to the agency for a special license as described under section 8 of the
MRTMA, MCL 333.27958, and issued pursuant to section 9 of the act, MCL
333.27959, and these rules. A person may apply to the agency for a special
license in any of the following categories:
(a) Designated consumption
establishment license. A designated consumption establishment license is valid
for 1 year.
(b) Excess marihuana grower
license. An excess marihuana grower license is valid for 1 year.
(c) Marihuana event
organizer license. A marihuana event organizer license is valid for 1 year.
(d) Temporary marihuana event
license. A temporary marihuana event license is valid for a minimum of 1 day
and ends on the date specified on the state license.
(e) Marihuana educational
research license. A marihuana educational research license is valid for 1 year.
(f) A class A marihuana
microbusiness license. A class A marihuana microbusiness license is valid for 1
year.
(2) An applicant shall meet
the requirements of the MRTMA and these rules to be eligible for a special
license.
(3) A person who allows
consumption of marihuana products on the premises of a non-residential location
and charges a fee for entry, sells goods or services while individuals are
consuming on the premises, or requires membership for entry shall acquire a
designated consumption establishment or temporary marihuana event license.
(1) A licensee may enter into a licensing agreement, management agreement,
manufacturing agreement, or other agreement. An agreement under this subrule
must be in writing.
(2) If an agreement under subrule (1) of this rule is a licensing agreement, management agreement, or would allow the other party to do either of the following, the licensee shall submit the agreement to the agency for approval:
(a) Exercise control over or participate in the management of the licensee.
(b) Receive more than a reasonable payment from the licensee during a full or partial calendar or fiscal year.
(3) If an agreement meets a condition of subrule (2) of this rule, a licensee shall submit a complete, unredacted, signed copy of the agreement to the agency for review and approval before the terms of the agreement take effect.
(4) An agreement under this rule must include, but is not limited to, all of the following:
(a) The legal name of each party.
(b) All price and payment terms between the parties. If the cost for a product or service is undefined, the method by which the cost will be calculated must be included.
(c) A requirement that all payments made to the other party pursuant to the agreement must be made by the licensee that is the party to the agreement.
(d) Terms specifically naming and clearly defining a service to be performed pursuant to the agreement.
(e) Terms specifically requiring that all operations related to the production, sales, invoicing, and payment for marihuana sold pursuant to an agreement must be performed by the licensee.
(f) A statement indicating that the agreement contains the entire agreement of the parties.
(g) If the agreement includes trademarked items, all trademark documentation, including registration certificates, filed with this state or the United States Patent and Trademark Office, or both.
(5) The agency shall not approve an agreement under this rule if the terms of the agreement would violate a requirement of the acts or these rules.
(6) A term or condition that would allow the licensee to use an assumed name or doing business as in the operation of the licensee is not operative unless the licensee has complied with the requirements of 1907 PA 101, MCL 445.1 to 445.5.
(7) A licensee shall provide other information requested by the agency pertaining to an agreement that is not inconsistent with the acts and these rules.
R 420.22 Designated
consumption establishment license Licensee records.
Rule 22. (1) An applicant
for a designated consumption establishment license is subject to and shall meet
the requirements of the Michigan regulation and taxation of marihuana act and
these rules.
(2) A person may apply for a
designated consumption establishment license on the form created by the agency
accompanied by the nonrefundable application fee as prescribed in these rules.
An application for a designated consumption establishment license must be made
under oath on a form provided by the agency. A complete application for a
designated consumption establishment license must contain the information
required in these rules and information regarding the designated consumption
establishment including, but not limited to, all of the following:
(a) A designated
consumption establishment plan for the proposed consumption establishment.
Upon the request of the agency, an applicant or licensee may be required to
submit a revised designated consumption establishment plan. The plan must
include a diagram of the designated consumption establishment including, but
not limited to, all of the following:
(i) The proposed
establishment’s size and dimensions.
(ii) Specifications of the
designated consumption establishment.
(iii) Physical address.
(iv) Location of common
entryways, doorways, or passageways.
(v) Means of public entry
or exit.
(vi) An indication of the
distinct areas or structures for separate marihuana establishments at the same
location as provided in these rules.
(b) A detailed floor plan
and layout that includes all of the following:
(i) Dimensions of the
consumption establishment including interior and exterior rooms.
(ii) Number of rooms.
(iii) Dividing structures.
(iv) Fire walls.
(v) Entrances and exits.
(vi) Locations of
hazardous material storage, if applicable.
(vii) Means of egress.
(c) Construction details
for structures and fire-rated construction for required walls.
(d) Building structure
information, including but not limited to, new, pre-existing, freestanding, or
fixed.
(e) Building type
information, including, but not limited to, commercial, warehouse, industrial,
retail, converted property, house, building, mercantile building, pole barn,
greenhouse, laboratory, or center.
(f) Zoning classification
and zoning information.
(g) If the proposed
designated consumption establishment is in a location that contains multiple
tenants, any applicable occupancy restrictions.
(h) A business plan that includes
a description of the proposed hours of operation.
(i) Proof of possession of
the premises where the proposed designated consumption establishment will be
located and, if the premises are leased, written permission from the owner of
the premises approving the applicant’s use of the designated consumption
establishment for marihuana consumption.
(j) A responsible
operations plan that includes a detailed explanation of how employees will
monitor and prevent over-intoxication, underage access to the designated
consumption establishment, the illegal sale or distribution of marihuana or
marihuana products within the consumption establishment, and any other
potential criminal activity on the premises.
(k) A documented employee
training that addresses all components of the responsible operations plan.
(l) A marihuana product
destruction and waste management plan that meets the requirements of these
rules, as applicable, for destroying and disposing of marihuana waste left at
the marihuana establishment.
(m) Any other information
required by the agency if not inconsistent with the Michigan regulation and
taxation of marihuana act and these rules.
(3) The agency may provide a
copy of the marihuana establishment plan to the BFS, local fire department,
building officials, the Michigan state police, and local law enforcement for
use in pre-incident review and planning.
(4) An applicant shall pay
the fees required under these rules.
(5) An applicant is subject
to the prelicensure investigation and proposed establishment inspection
required under these rules.
(6) An applicant is subject
to the proof of financial responsibility and insurance requirements under these
rules.
(7) A designated consumption
establishment shall have the following characteristics:
(a) A smoke-free area for
employees to monitor the marihuana consumption area.
(b) A ventilation system
that directs air from the marihuana consumption area to the outside of the
building through a filtration system sufficient to remove visible smoke,
consistent with all applicable building codes and ordinances, and adequate to
eliminate odor at the property line, if consumption by inhalation is permitted.
(c) A location physically
separated from areas where smoking is prohibited and where smoke does not
infiltrate into nonsmoking areas or buildings.
(8) The agency may determine
an applicant is ineligible or deny an application for the reasons specified in
these rules, as applicable. (1) A licensee shall maintain records that
are required to be maintained under the acts or these rules on site at the
marihuana business or in a way that the records can be accessed electronically
on site and made available for review by the agency during business hours.
(2) A licensee shall utilize a general ledger software and standard double entry bookkeeping system.
(3) A licensee shall maintain accurate and comprehensive financial records for each license that clearly document the licensee’s income and expenses, including, but not limited to, all of the following:
(a) Cash logs.
(b) Bank statements.
(c) Sales records.
(d) Inventory purchase records.
(e) Invoices.
(f) Receipts.
(g) Deposit slips.
(h) Cancelled checks.
(i) Employee compensation records.
(j) Tax records.
(k) General ledger.
(4) Bulk financial deposits or transactions must be traceable to the individual transactions that comprise the bulk deposit or transaction.
(5) Licensee records must be maintained for not less than 4 years, unless the agency requires a record to be maintained for a longer period of time. If the agency requires a licensee to maintain a record for longer than 4 years, the licensee shall not dispose of the record until the agency approves disposal of the record.
(6) A licensee that holds a license as a cultivator, producer, or marihuana sales location shall perform, document, and maintain as an internal record, monthly reconciliations of its statewide monitoring system revenue to its general ledger revenue and, if applicable, point-of-sale revenue. The licensee shall document all discrepancies and maintain all relevant source documentation.
(7) A licensee shall maintain records in a way that allows the licensee to identify and reconcile revenue and expenses related to marihuana operations separate from revenue or expenses related to industrial hemp operations.
(8) A licensee conducting business under a licensing agreement, management services agreement, manufacturing agreement, or other agreement shall maintain records documenting all marihuana and money transferred pursuant to the agreement.
R 420.23 Excess marihuana
grower license Marihuana business websites; public representations;
ownership.
Rule 23. (1) An applicant
for an excess marihuana grower license is subject to and shall meet the requirements
of the MRTMA and these rules.
(3) An excess marihuana
grower license may be issued only to a person who holds 5 stacked class C
marihuana grower licenses issued by the agency under the MRTMA and at least 2
grower class C licenses issued by the agency under the MMFLA.
(4) A person may apply for
an excess marihuana grower license on the form created by the agency
accompanied by the nonrefundable application fee as prescribed in these rules.
An application for an excess marihuana grower license must be made under oath
on a form provided by the agency and must contain information as prescribed by
the agency.
(5) An applicant for an
excess marihuana grower license shall pay applicable fees required under these
rules.
(6) The agency may determine
an applicant is ineligible or deny an application for the reasons specified in
these rules.
(7) The agency shall set the
total marihuana plant count for an excess marihuana grower license in
increments of 2,000 marihuana plants not in excess of the total marihuana
plants permitted under grower class C licenses held under the MMFLA.
(8) Payment of the initial
licensure fee must be received prior to issuance of the state license. In
determining the initial licensure fee for an excess marihuana grower license,
the initial licensure fee of a class C marihuana grower license is assessed on
the excess marihuana grower license at every 2,000 marihuana plant increment
authorized by the state license.
(9) An excess marihuana
grower licensee is subject to all requirements for a marihuana grower as
provided for in the MRTMA and these rules, as applicable.
(10) An applicant shall pay
the initial licensure fee for an excess grower license within 10 calendar days
of approval or within 90 calendar days of submitting a complete application,
whichever date is first.
(11) An applicant for an
excess grower license is not required to pay the application fee under these
rules. A licensee shall not publicly represent ownership or ownership
structures that differ from the ownership information provided to the agency,
including, but not limited to, on a website or social media page or social
media profile owned or controlled by the licensee.
R 420.24 Marihuana event
organizer license Court-appointed individuals.
Rule 24. (1) A marihuana
event organizer is not authorized to engage in the operations of a marihuana
establishment licensee without first obtaining the appropriate licenses.
(2) A person may apply for a
marihuana event organizer license on the form created by the agency accompanied
by the application fee as prescribed in these rules. An application for a
marihuana event organizer license shall be made under oath on a form provided
by the agency and shall contain information as prescribed by the agency.
(3) An applicant for a
marihuana event organizer license is subject to and shall meet the requirements
of these rules, as applicable.
(4) An applicant for a
marihuana event organizer license shall pay the nonrefundable application fee
and any other fees required under these rules.
(5) The agency may determine
an applicant is ineligible or deny an application for the reasons specified in
these rules, as applicable. If a court-appointed receiver, trustee,
personal representative, guardian, or another individual is appointed to
operate a marihuana business, the receiver, trustee, personal representative,
guardian, or other individual shall ensure that the marihuana business complies
with all the requirements in the acts and these rules for which the licensee
would otherwise be responsible.
R 420.25 Temporary marihuana
event license; application; operations. Rescinded.
Rule 25. (1) A
temporary marihuana event license may be issued only to a person who holds a
marihuana event organizer license issued by the agency.
(2) Violations of the
requirements applicable to temporary marihuana events may result in
disciplinary action against the marihuana event organizer license or any other
licenses held by a licensee participating in the temporary marihuana event and
responsible for a violation of the MRTMA or these rules.
(3) A temporary marihuana
event license may be issued only for a single day or up to 7 consecutive days.
A temporary marihuana event license may not be issued for more than 7 days.
(4) An application for a
temporary marihuana event license must be submitted to the agency not less than
90 calendar days before the first day of the temporary marihuana event.
(5) A temporary marihuana
event may be held only at a venue expressly approved by a municipality for the
purpose of holding a temporary marihuana event.
(6) A temporary marihuana
event may be held only if the applicant is expressly approved by a municipality
to hold a temporary marihuana event where sales to, or consumption of marihuana
by, persons 21 years of age or older will occur.
(7) An application for a
temporary marihuana event license must be made under oath on a form provided by
the agency and must contain information as prescribed by the agency, including,
at a minimum, all of the following:
(a) The name of the
applicant. Applicants who are individuals shall provide both the first and last
name of the individual. Applicants that are business entities shall provide the
legal business name of the applicant.
(b) The marihuana event
organizer license number and license number of any other marihuana
establishment license held by the applicant.
(c) The address of the
location where the temporary marihuana event will be held.
(d) The name of the
temporary marihuana event.
(e) A diagram of the
physical layout of the temporary marihuana event that clearly indicates each of
the following:
(i) Where the temporary
marihuana event will take place on the location grounds.
(ii) All entrances and
exits that will be used by participants during the event.
(iii) All marihuana
consumption areas.
(iv) All marihuana retail
areas where marihuana products will be sold.
(v) All areas where
marihuana waste will be stored.
(vi) All areas where
marihuana products will be stored.
(vii) The specific
location of each marihuana retailer or marihuana microbusiness or class A
marihuana microbusiness licensee who will be participating in the event. Each
marihuana retailer or marihuana microbusiness or class A marihuana microbusiness
licensee participating in the event must be identified with an assigned
temporary marihuana event location number.
(f) The dates and hours of
operation for the proposed temporary marihuana event. A temporary marihuana
event license is required for any date in which the applicant engages in onsite
marihuana product sales or allows onsite marihuana product consumption.
(g) Contact information for
the designated primary contact person for the temporary marihuana event
license, including the individual’s name, title, address, phone number, and
email address.
(h) Contact information for
the designated contact person or persons who must be onsite at the event, and
reachable by telephone at all times that the event is occurring.
(i) For an applicant seeking
licensure for a temporary marihuana event, confirmation of municipal compliance
on an attestation form provided by the agency that includes all of the
following:
(i) The name and address
of the proposed temporary marihuana event.
(ii) The municipality
where the proposed temporary marihuana event is located.
(iii) The contact
information for the municipality including, at a minimum, all of the following:
(A) The name of the clerk
of the municipality or his or her designee.
(B) The telephone number
of the clerk of the municipality or his or her designee.
(C) The email address of
the clerk of the municipality or his or her designee.
(D) The mailing address
of the clerk of the municipality or his or her designee.
(iv) Confirmation that the
municipality has not adopted an ordinance prohibiting the proposed temporary
marihuana event.
(v) Confirmation that the
applicant is in compliance with any ordinance the municipality has adopted
relating to marihuana establishments within its jurisdiction, including zoning
regulations.
(vi) Attestation that the
applicant will report any changes that occur with municipal ordinances or
zoning regulations that relate to the proposed temporary marihuana event, any
municipal approvals, or any violations of a municipal or zoning regulation.
(vii) Attestation by the
applicant describing if the applicant will engage in onsite marihuana sales to,
and allow onsite consumption by, person 21 years of age or older at the
temporary marihuana event.
(viii) The date and
signature of the applicant.
(j) A list of all licensees
and employees who will be providing onsite sales of marihuana products at the
temporary marihuana event. If the list of licensees and employees participating
in the temporary marihuana event changes after the application is submitted or
after the temporary marihuana event license is issued, the applicant shall
submit an updated list and an updated diagram to the agency not less than 72
hours before the event. Licensees not on the list submitted to the agency may
not participate in the temporary marihuana event.
(k) A responsible
operations plan that includes a detailed explanation of how employees will
monitor and prevent over-intoxication, underage access to the designated
consumption establishment, the illegal sale or distribution of marihuana or
marihuana products within the consumption establishment, and any other
potential criminal activity on the premises.
(8) An applicant for a
temporary marihuana event shall pay all required fees before the agency issues
a temporary marihuana event license.
(9) The licensed marihuana
event organizer shall hire or contract for licensed security personnel to
provide security services at the licensed temporary marihuana event. All
security personnel hired or contracted for by the licensee shall be at least 21
years of age, and be present on the licensed event premises at all times
marihuana products are available for sale or marihuana consumption is allowed
on the licensed event premises. The security personnel shall not engage in the
consumption of marihuana products before or during the event.
(10) A licensed marihuana
event organizer shall maintain a clearly legible sign, not less than 7 by 11
inches in size reading, “No Persons Under 21 Allowed” at or near each public
entrance to any area where the sale or consumption of marihuana products is
allowed. The lettering of the sign shall be not less than 1 inch in height.
(11) The marihuana event
organizer licensee shall ensure that access to the event is restricted to
persons 21 years of age or older and ensure that marihuana sales or consumption
is not visible from any public place or non-age-restricted area.
(12) The marihuana event
organizer licensee, who holds the temporary marihuana event license, is
responsible for ensuring that all rules and requirements for the onsite
consumption of marihuana products are followed.
(13) The marihuana event
organizer licensee shall ensure that all marihuana waste generated at a
temporary marihuana event is collected and disposed of in accordance with the
requirements of these rules, as applicable.
(14) A licensed marihuana
event organizer and all other licensees participating in a temporary marihuana
event are required to comply with all other applicable requirements in the
MRTMA and these rules and any municipal ordinances.
(15) The agency may require
the marihuana event organizer and all participants to cease operations without
delay if in the opinion of the agency or law enforcement it is necessary to
protect the immediate public health and safety of the people of this state.
Upon notification from the agency that the event is to cease operations, the
marihuana event organizer shall immediately stop the event and all participants
must be removed from the premises within the time frame provided by the agency.
(16) Upon notification from
the agency, the marihuana event organizer shall immediately expel from the
event any person selling marihuana products without a marihuana retailer,
marihuana microbusiness, or class A marihuana microbusiness license issued by
the agency. The marihuana event organizer or his or her representative shall
remain with the person being expelled from the premises at all times until he
or she vacates the premises. If the person does not vacate the premises, the
agency may inform the marihuana event organizer that the event must cease
operations. Upon notification from the agency that the event is to cease
operations, the marihuana event organizer shall immediately stop the event and
all participants must be removed from the premises within the time frame
provided by the agency.
R 420.26 Temporary marihuana
event fee. Rescinded.
Rule 26. (1) Each marihuana
event organizer licensed to hold a temporary marihuana event in this state
shall pay an initial licensure fee that consists of both of the following:
(a) For temporary marihuana
events that do not include the sale of marihuana products, a $500.00 fee for
each day of the scheduled event to cover the agency’s enforcement and
compliance costs.
(b) For temporary marihuana
events that include the sale of marihuana products:
(i) A $500.00 fee for each
licensee authorized to sell marihuana product at the event to
cover the agency’s enforcement and compliance costs.
(ii) A $500.00 fee for
each day of the temporary marihuana event to cover the agency’s enforcement and
compliance costs.
(2) If a licensee scheduled
to attend an event withdraws from the event prior to the first day of the
event, the marihuana event organizer may request a refund for that portion of
the fees paid to the agency to cover the enforcement and compliance costs for
that licensee.
(3) A marihuana event
organizer applicant is not required to pay an application fee.
R 420.27 Temporary marihuana
event sales. Rescinded.
Rule 27. (1) A marihuana
event organizer licensee shall ensure that access to the area where marihuana
sales are allowed is restricted to persons 21 years of age or older.
(2) Only persons 21 years of
age or older may purchase and consume marihuana products at a temporary
marihuana event. Prior to selling marihuana products to a customer, the
licensee making the sale shall confirm, using valid identification as specified
in the MRTMA and these rules, the age and identity of the customer.
(3) All sales of marihuana
products at a temporary marihuana event shall occur in a retail area as
designated in the premises diagram required in these rules.
(4) Each sale at a temporary
marihuana event must be performed by a licensed marihuana retailer, a marihuana
microbusiness, or a class A marihuana microbusiness that is authorized to sell
marihuana products to customers. The marihuana event organizer may also sell
marihuana products at the temporary marihuana event if the marihuana event
organizer holds a separate state license as a marihuana retailer, a marihuana
microbusiness, or a class A marihuana microbusiness.
(5) Licensed marihuana
retailers, marihuana microbusinesses, or class A marihuana microbusinesses
shall conduct sales activities only within their specifically assigned area,
identified in the diagram of the physical layout of the temporary marihuana
event.
(6) Mobile sales activities
via wagon, cart, or similar means are prohibited at the temporary marihuana
event site.
(7) Licensed marihuana
retailers, marihuana microbusinesses, or class A marihuana microbusinesses
shall prominently display their temporary marihuana event location number and
state license number within plain sight of the public.
(8) All sales at a temporary
marihuana event must occur on the dates stated on the state license and must
occur at the location stated on the state license. All onsite sales of
marihuana products must comply with the hours of operation requirements in
these rules.
(9) The marihuana products
sold onsite at a temporary marihuana event must be transported to the site of
the temporary marihuana event by a licensed secure transporter in compliance
with the Michigan regulation and taxation of marihuana act and these rules. A
licensed transporter is not required if less than 15 ounces of marihuana or 60
grams of concentrate is transported at 1 time.
(10) Except small amounts of
products used for display, all marihuana products for sale at a temporary
marihuana event must be stored in a secure, locked container that is not
accessible to the public. Marihuana products stored by a licensee at a
temporary marihuana event must not be left unattended.
(11) All marihuana products
made available for sale at a temporary marihuana event by a licensee must
comply with all requirements of the MRTMA and these rules for the sale and
tracking of marihuana products. This includes, at a minimum, all of the
following:
(a) Identifying marihuana
product from licensees’ inventory at the marihuana establishment that will be
transported for sale at the event using a marihuana secure transporter or an
agent of the licensee to the temporary marihuana event.
(b) Tracking in the
statewide monitoring system any sales of marihuana product at the event in
accordance with the requirements of these rules.
(c) Tracking in the
statewide monitoring system any marihuana product that is not sold at the event
and is returned to the marihuana establishment’s inventory at its permanent
location. If more than 15 ounces of marihuana or 60 grams of concentrate is
transported at 1 time, it must be transported using a marihuana secure
transporter.
R 420.27a
Marihuana educational research license. Rescinded.
Rule 27a. (1) A marihuana
educational research license authorizes a licensee to do all of the following:
Obtain marihuana from a
marihuana establishment.
Produce marihuana products.
Perform research on marihuana
and marihuana products.
Dispose of marihuana and
marihuana products.
(2) A licensee holding a
marihuana educational research license shall apply for the necessary
registration from the United States Drug Enforcement Administration (DEA). A
licensee must provide proof of registration to the agency before engaging in
any licensed activity.
(3) An application for a
marihuana educational research license must be made under oath on a form
provided by the agency. A complete application for a marihuana educational
research license must contain the information required in these rules and
information regarding the marihuana educational research license including, at
a minimum, all of the following:
(a) A research plan
including, at a minimum, all of the following:
(i) A written plan for
documenting all individuals who will have access to the location and marihuana
or marihuana products.
(ii) Detailed description
and documentation of affiliation with a degree or certificate program offered
by an institution of higher learning accredited by the Higher Learning Commission.
(iii) A brief description
of the research that will be conducted.
(iv) A written plan to
ensure secure delivery and receipt of marihuana at the licensed location.
(v) A written plan to
ensure the safe storage of marihuana at the licensed location.
(vi) A written plan for
the tracking of marihuana quantities at the licensed location.
(vii) A written plan for
the disposal of marihuana after research.
(viii) A floor plan of the
location.
(b) For an applicant
seeking licensure for a marihuana educational research license, confirmation of
municipal compliance on an attestation form provided by the agency that
includes all of the following:
(i) The name and address
of the proposed marihuana educational research license.
(ii) The municipality
where the proposed marihuana educational research license is located.
(iii) The contact
information for the municipality including, at a minimum, all of the following:
(A) The name of the clerk
of the municipality or his or her designee.
(B) The telephone number
of the clerk of the municipality or his or her designee.
(C) The email address of
the clerk of the municipality or his or her designee.
(D) The mailing address
of the clerk of the municipality or his or her designee.
(iv) Confirmation that the
municipality has not adopted an ordinance prohibiting the proposed marihuana
educational research license.
(v) Confirmation that the
applicant is in compliance with any ordinance the municipality has adopted
relating to marihuana establishments within its jurisdiction, including zoning
regulations.
(vi) Attestation that the
applicant will report any changes that occur with municipal ordinances or
zoning regulations that relate to the proposed marihuana educational research
license, any municipal approvals, or any violations of a municipal or zoning
regulation.
(vii) The date and
signature of the applicant.
(c) A certificate of use
and occupancy pursuant to R 420.208 in which the authorized activities of the
marihuana educational research license are to be conducted.
(d) Any other documents
required by the agency that are not inconsistent with the acts and these rules.
(4) An applicant for a
marihuana educational research license shall provide notification and report to
the agency in writing within 24 hours when he or she became aware of or should
have become aware of all of the following:
(a) Loss of institutional
affiliation.
(b) Loss of institutional
accreditation.
(c) Loss or restriction of
DEA registration.
(d) Theft, loss, diversion,
or criminal activity at the licensed location.
(5) A marihuana educational
research licensee shall maintain and provide upon request of the agency a
written schedule for disposal of marihuana and marihuana products after it has
concluded research on that item.
(6) A marihuana educational
research licensee shall accurately enter all transactions, current inventory,
and other information into the statewide monitoring system as required by the
agency.
(7) A marihuana educational
research licensee shall not sell or transfer marihuana or marihuana products to
a marihuana establishment or to a marihuana customer.
(8) A marihuana educational
research licensee shall designate and enter into the statewide monitoring
system administrative users pursuant to R 420.602(2)(b) and (c) as required by
the agency.
(9) A marihuana educational
research licensee shall prohibit marihuana or marihuana products grown,
produced, or obtained under the license to be consumed or sampled on the
licensed premises unless the licensee is approved to engage in a research study
under R 420.510(11) or the licensee obtains express written permission from the
agency.
R 420.27b Class A marihuana
microbusiness. Rescinded.
Rule 27b. (1) An applicant
for a class A marihuana microbusiness license is subject to and shall meet the
requirements of the MRTMA and these rules.
(2) An application for a
class A marihuana microbusiness license must be made under oath on a form
provided by the agency and must contain information as prescribed by the
agency.
(3) An applicant for a class
A marihuana microbusiness license shall pay applicable fees as required under
these rules.
(4) The agency may determine
that an applicant is ineligible for a license or may deny an application for
the reasons specified in these rules, as applicable.
(5) Payment of the initial
licensure fee must be received prior to issuance of the state license.
(6) A class A marihuana
microbusiness licensee is subject to all requirements for a marihuana
microbusiness as provided for in the MRTMA and these rules, unless modified in
these rules.
(7) An applicant shall pay
the initial licensure fee for a class A marihuana microbusiness license within
10 calendar days of approval or within 90 calendar days of submitting a
complete application, whichever date is first.
R 420.28 Renewal;
notifications; inspections and investigations; penalties; sanctions; fines;
sale or transfer. Rescinded.
Rule 28. (1) A designated
consumption establishment, class A marihuana microbusiness, marihuana
educational research license, and marihuana event organizer license are issued
for a 1-year period and may be renewed. An applicant for renewal must meet the
requirements, as applicable, and apply in the manner prescribed in these rules.
(2) A designated consumption
establishment, class A marihuana microbusiness, marihuana educational research
license, and marihuana event organizer applicant or licensee are subject to the
notification and reporting requirements specified in these rules, as
applicable.
(3) A designated consumption
establishment, class A marihuana microbusiness, marihuana educational research
license, or marihuana event organizer licensee or licensee participating in a
temporary marihuana event shall comply with the notification requirements for
theft, loss, or criminal activity pertaining to marihuana product under these
rules, as applicable.
(4) An applicant for or a
licensed designated consumption establishment, class A marihuana microbusiness,
marihuana educational research license, or marihuana event organizer are
subject to the inspections and investigations specified in these rules, as
applicable.
(5) An applicant for or a
licensed designated consumption establishment, class A marihuana microbusiness,
marihuana educational research license, or marihuana event organizer are
subject to these rules regarding violations, sanctions, and fines.
(6) A licensee selling
marihuana products at a temporary marihuana event shall comply with the
requirements of these rules regarding the sale or transfer of marihuana.
(7) A licensee selling
marihuana products at a temporary marihuana event shall comply with the
requirements of these rules regarding purchasing limits in a single
transaction.
R 420.29 Severability. Rescinded.
Rule 29. If any rule or
subrule of these rules, in whole or in part, is found to be invalid by a court
of competent jurisdiction, such decision will not affect the validity of the remaining
portion of these rules.
DEPARTMENT
OF LICENSING AND REGULATORY AFFAIRS
MARIJUANA
REGULATORY AGENCY
MARIHUANA
LICENSEES
(By authority conferred on the
executive director of the marijuana regulatory agency by section 206 of the
medical marihuana facilities licensing act, 2016 PA 281, MCL 333.27206,
sections 7 and 8 of the Michigan Regulation and Taxation of Marihuana Act, 2018
IL 1, MCL 333.27957 and 333.27958, and Executive Reorganization Order No.
2019-2, MCL 333.27001)
PART 3. ADDITIONAL MARIHUANA LICENSE TYPES
R 420.101 Definitions Additional
license types.
Rule 1101. (1)
As used in these rules:
(a) “Acts” refers to the
medical marihuana facilities licensing act, 2016 PA 281, MCL 333.27101 to
333.27801, and the Michigan Regulation and Taxation of Marihuana Act, 2018 IL
1, MCL 333.27951 to 333.27967, when applicable.
(b) “Agency” means the marijuana
regulatory agency.
(c) “Another party” or
“other party” means an individual or company with which a licensee contracts to
use the individual’s or company’s intellectual property or to utilize
management or other services provided by the individual or company.
(d) "Applicant"
means a person who applies for a marihuana license, subject to paragraphs (i)
and (ii) of this subdivision:
(i) For purposes of this
definition, an applicant includes a managerial employee of the applicant, a
person holding a direct or indirect ownership interest of more than 10% in the
applicant, and the following for each type of applicant:
(A) For an individual or
sole proprietorship: the proprietor and spouse.
(B) For a partnership and
limited liability partnership: all partners and their spouses.
(C) For a limited
partnership and limited liability limited partnership: all general and limited
partners, not including a limited partner holding a direct or indirect
ownership interest of 10% or less who does not exercise control over or
participate in the management of the partnership, and their spouses.
(D) For a limited
liability company: all members and managers, not including a member holding a
direct or indirect ownership interest of 10% or less who does not exercise
control over or participate in the management of the company, and their
spouses.
(E) For a privately held
corporation: all corporate officers or persons with equivalent titles and their
spouses, all directors and their spouses, all stockholders, not including those
holding a direct or indirect ownership interest of 10% or less, and their
spouses.
(F) For a publicly held
corporation: all corporate officers or persons with equivalent titles and their
spouses, all directors and their spouses, all stockholders, not including those
holding a direct or indirect ownership interest of 10% or less, and their
spouses.
(G) For a multilevel
ownership enterprise: any entity or person that receives or has the right to
receive more than 10% of the gross or net profit from the enterprise during any
full or partial calendar or fiscal year.
(H) For a nonprofit
corporation: all individuals and entities with membership or shareholder rights
in accordance with the articles of incorporation or the bylaws and their
spouses.
(I) For a trust:
trustees, any individual or body able to control and direct the affairs of the
trust, and any beneficiary who receives or has the right to receive more than
10% of the gross or net profit of the trust during any full or partial calendar
or fiscal year and their spouses.
(ii) For purposes of this
definition, an applicant does not include:
(A) A person who provides
financing to an applicant or licensee under a bona fide financing agreement at a
reasonable interest rate unless the person exercises control over or
participates in the management of the marihuana business.
(B) A franchisor who
grants a franchise to an applicant, if the franchisor does not have the right
to receive royalties based upon the sale of marihuana or marihuana-infused
products by the applicant who is a franchisee. Nothing in this subrule shall be
construed to preclude a franchisor from charging an applicant who is a
franchisee a fixed fee. As used in this definition, the terms “franchise,”
“franchisor,” and “franchisee” have the meanings set forth in section 2 of the
franchise investment law, 1974 PA 269, MCL 445.1502.
(C) A person receiving
reasonable payment for rent on a fixed basis under a bona fide lease or rental
obligation unless the person exercises control over or participates in the
management of the marihuana business.
(D) A person receiving
reasonable payment under a licensing agreement or contract approved by the
agency concerning the licensing of intellectual property including, but not
limited to, brands and recipes.
(E) A person who receives
a percentage of profits as an employee if the employee does not meet the
definition of “managerial employee” and the employee does not receive more than
10% of the gross or net profit from the licensee during any full or partial
calendar or fiscal year.
(F) A person who receives
a bonus as an employee if the employee is on a fixed wage or salary and the
bonus is not more than 25% of the employee’s pre-bonus annual compensation or
if the bonus is based upon a written incentive/bonus program that is not out of
the ordinary for the services rendered.
(e) “Clone” means a
replication of a single parent plant through vegetative propagation.
(f) “Common ownership”
means 2 or more state licenses or 2 or more equivalent licenses held by 1
person under the Michigan Regulation and Taxation of Marihuana Act.
(g) “Employee” means a
person performing work or service for compensation. “Employee” does not
include individuals providing trade or professional services who are not
normally engaged in the operation of a marihuana business.
(h) “Immature plant” means
a nonflowering marihuana plant that is no taller than 8 inches from the growing
or cultivating medium and no wider than 8 inches, produced from a cutting,
clipping, tissue culture, or seedling, and that is in a growing or cultivating
medium or in a growing or cultivating container.
(i) “Industrial hemp” means
that term as defined in section 3 of the Michigan regulation and taxation of
marihuana act, 2018 IL 1, MCL 333.27953.
(j) “Industrial hemp
research and development act” means the industrial hemp research and
development act, 2014 PA 547, MCL 286.841 to 286.859.
(k) “Intellectual property”
means all original data, findings, or other products of the mind or intellect
commonly associated with claims, interests, and rights that are protected under
trade secret, patent, trademark, copyright, or unfair competition law and
includes brands or recipes.
(l) “Licensing agreement”
means any understanding or contract concerning the licensing of intellectual
property related to marihuana products between a licensee and another party.
(m) “Management agreement”
means any understanding or contract between a licensee and another party for
the provision of management or other services that would allow the other party
to exercise control over or participate in the management of the licensee or to
receive more than 10% of the gross or net profit from the licensee during any
full or partial calendar or fiscal year. A management agreement does not
include an agreement for the reasonable payment of rent on a fixed basis under
a bona fide lease or rental obligation unless the person exercises control over
or participates in the management of the marihuana business.
(n) “Managerial employee”
means those employees who have the ability to control and direct the affairs of
the marihuana business or have the ability to make policy concerning the
marihuana business, or both.
(o) “Marihuana business”
means a marihuana facility under the medical marihuana facilities licensing
act, or a marihuana establishment under the Michigan Regulation and Taxation of
Marihuana Act, or both.
(p) “Marihuana
establishment” means a marihuana grower, marihuana safety compliance facility,
marihuana processor, marihuana microbusiness, marihuana retailer, marihuana
secure transporter, or any other type of marihuana-related business licensed by
the agency under the Michigan Regulation and Taxation of Marihuana Act.
(q) “Marihuana facility”
means a location at which a licensee is licensed to operate under the medical
marihuana facilities licensing act.
(r) “Marihuana license”
means a state operating license issued under the medical marihuana facilities
licensing act, or a state license issued under the Michigan Regulation and
Taxation of Marihuana Act, or both.
(s) “Marihuana product”
means marihuana or a marihuana-infused product, or both, as those terms are
defined in the applicable act unless otherwise provided for in these rules.
(t) “Mature plant” means a
flowering or nonflowering marihuana plant that has taken root and is taller
than 8 inches from the growing or cultivating medium or wider than 8 inches,
produced from a cutting, clipping, tissue culture, or seedling, and that is in
a growing or cultivating medium or in a growing or cultivating container.
(u) “Medical marihuana
facilities licensing act” or “MMFLA” means the medical marihuana facilities
licensing act, 2016 PA 281, MCL 333.27101 to 333.27801.
(v) “Michigan Regulation
and Taxation of Marihuana Act” or “MRTMA” means the Michigan Regulation and
Taxation of Marihuana Act, 2018 IL 1, MCL 333.27951 to 333.27967.
(w) “Marihuana tracking
act” means the marihuana tracking act, 2016 PA 282, MCL 333.27901 to 333.27904.
(x) “Parties” means a
licensee and another party pursuant to a licensing or management agreement.
(y) “These rules” means the
administrative rules promulgated by the agency under the authority of the
medical marihuana facilities licensing act, the marihuana tracking act, the
Michigan Regulation and Taxation of Marihuana Act, and Executive Reorganization
Order No. 2019-2, MCL .333.27001.
(z) “Same location” means
separate marihuana licenses that are issued to multiple marihuana businesses
that are authorized to operate at a single property but with separate business
suites, partitions, or addresses.
(2) Terms defined in the
acts have the same meanings when used in these rules unless otherwise
indicated. (1) The following additional licenses are created under
section 8(2)(a) of the MRTMA, MCL 333.27958:
(a) Designated consumption establishment license.
(b) Excess marihuana grower license.
(c) Marihuana event organizer license.
(d) Temporary marihuana event license.
(e) Marihuana educational research license.
(f) Class A marihuana microbusiness license.
(2) Except for a temporary marihuana event license, a special license is issued for a 1-year period and is renewable annually.
(3) A person may apply for a license listed under subrule (1) of this rule as provided in part 2 of these rules.
PART 1. LICENSEES
UNDER THE MICHIGAN REGULATION AND TAXATION OF MARIHUANA ACT
R 420.102 Marihuana grower
license Designated consumption establishment license.
Rule 2102. (1)
A marihuana grower license authorizes the marihuana grower to cultivate not
more than the following number of marihuana plants under the indicated license
class for each marihuana grower license the marihuana grower holds in that
class:
(a) Class A – 100
marihuana plants.
(b) Class B – 500
marihuana plants.
(c) Class C – 2,000
marihuana plants.
(2) For the purposes of this
rule, only mature marihuana plants are included in the plant count in subrule
(1) of this rule.
(3) Except as otherwise
provided in the MRTMA and these rules, a marihuana grower license authorizes
sale of marihuana and marihuana plants to a marihuana grower only by means of a
marihuana secure transporter. A marihuana grower license authorizes the sale or
transfer of seeds, seedlings, tissue cultures, or immature plants to a
marihuana grower from another marihuana grower without using a marihuana secure
transporter.
(4) A marihuana grower
license authorizes a marihuana grower to transfer marihuana without using a
marihuana secure transporter to a marihuana processor or marihuana retailer if
both of the following are met:
(a) The marihuana
processor or marihuana retailer occupies the same location as the marihuana
grower and the marihuana is transferred using only private real property
without accessing public roadways.
(b) The marihuana grower
enters each transfer into the statewide monitoring system.
(5) A marihuana grower
license authorizes sale of marihuana, other than seeds, seedlings, tissue
cultures, immature plants, and cuttings, to a marihuana processor or marihuana
retailer.
(6) Except as otherwise
provided in the MRTMA, subrules (3) and (4) of this rule, and R 420.304, a
marihuana grower license authorizes the marihuana grower to transfer marihuana
only by means of a marihuana secure transporter.
(7) A marihuana grower must
accurately enter all transactions, current inventory, and other information
into the statewide monitoring system as required in these rules.
(8) A marihuana grower
license does not authorize the marihuana grower to operate in an area unless
the area is zoned for industrial or agricultural uses or otherwise meets the
requirements established in section 9(3)(c) of the MRTMA, MCL 333.27959(c).
(9) A marihuana grower may
purchase or accept the transfer of marihuana seeds, tissue cultures, and clones
that do not meet the definition of marihuana plant in these rules at any time
from another grower licensed under the acts.
(10) A class A marihuana
grower may accept the transfer of marihuana plants only once upon licensure
from a registered primary caregiver if the registered primary caregiver was an
applicant for that class A marihuana grower license.
(11) A marihuana grower
licensee is required to comply with the requirements of the MRTMA and these
rules.
(12) A marihuana grower may
not purchase or accept the transfer of a mature plant from an individual,
registered qualifying patient, or registered primary caregiver. (1) A
person that allows consumption of marihuana on the premises of a
non-residential location and does any of the following for longer than 7
consecutive days shall obtain a designated consumption establishment license:
(a) Charges a fee for entry.
(b) Sells goods or services while individuals are consuming on the premises.
(c) Requires membership for entry.
(2) In addition to the requirements in part 2 of these rules, a person that applies for a designated consumption establishment license shall submit all of the following:
(a) Proof that the applicant owns the location or, if the location is leased, written permission from the owner of the location approving the applicant’s use of the location for the on-site consumption of marihuana.
(b) A responsible operations plan that includes a detailed explanation of how employees will monitor and prevent any of the following on the premises:
(i) Over-intoxication.
(ii) Underage access to the designated consumption establishment.
(iii) The illegal sale or distribution of marihuana within the consumption establishment.
(iv) Any other criminal activity.
(c) A documented employee training that addresses all components of the responsible operations plan.
(d) A waste management plan that meets the requirements of R 420.211 for disposing of marihuana waste left at the marihuana establishment.
(3) A designated consumption establishment may be co-located with a non-marihuana business.
(4) If a non-marihuana business requires a federal, state, or local license or other authorization to operate, the designated consumption establishment must not be co-located with the non-marihuana business until the non-marihuana business obtains permission to be co-located with a designated consumption establishment from the federal, state, or local authority that grants the license or other authorization.
(5) A designated consumption establishment must not be co-located with the licensed premises of a liquor license issued under the Michigan liquor control code of 1998, 1998 PA 58, MCL 436.1101 to 436.2303, and shall not allow the sale, serving, or consumption of alcohol onsite.
(6) A designated consumption establishment shall do both of the following:
(a) Dispose of marihuana waste or marihuana plant waste left at the establishment.
(b) Maintain a log of marihuana waste and marihuana plant waste, which must include a description of the waste and the amount and the manner in which it was disposed.
R 420.103 Marihuana processor
license Excess marihuana grower license.
Rule 3103. (1)
A marihuana processor license authorizes the marihuana processor to purchase or
transfer of marihuana or marihuana-infused products from only a licensed
marihuana establishment and sell or transfer of marihuana-infused products or
marihuana to only a licensed marihuana establishment.
(2) Except as otherwise
provided in these rules and the MRTMA, a marihuana processor license authorizes
a marihuana processor to transfer marihuana only by means of a marihuana secure
transporter. A marihuana processor license authorizes a marihuana processor to
transfer marihuana without using a marihuana secure transporter to a marihuana
grower, marihuana processor, or marihuana retailer if both of the following are
met:
(a) The marihuana grower,
marihuana processor, or marihuana retailer occupies the same location as the
marihuana processor and the marihuana is transferred using only private real
property without accessing public roadways.
(b) The marihuana processor
enters each transfer into the statewide monitoring system.
(3) A marihuana processor
must accurately enter all transactions, current inventory, and other
information into the statewide monitoring system as required in these rules. (1)
An excess marihuana grower may engage in any activity in which a class C
marihuana grower may engage.
(2) An excess marihuana grower shall comply with all requirements with which a class C marihuana grower must comply.
(3) The agency shall not issue an initial excess marihuana grower license but shall renew the excess marihuana grower license of a licensee that meets the requirements for renewal under part 2 of these rules.
R 420.104. Marihuana
retailer license Marihuana event organizer license.
Rule 4104. (1)
A marihuana retailer license authorizes the marihuana retailer to purchase or
transfer of marihuana or marihuana-infused products from only a licensed
marihuana establishment and sell or transfer to only a licensed marihuana
establishment or an individual 21 years of age or older. Except as otherwise
provided in these rules, and the MRTMA, all transfers of marihuana to a
marihuana retailer from a separate marihuana establishment must be by means of
a marihuana secure transporter. A transfer of marihuana to a marihuana retailer
from a marihuana establishment that occupies the same location as the marihuana
retailer does not require a marihuana secure transporter if the marihuana is
transferred to the marihuana retailer using only private real property without
accessing public roadways.
(2) A marihuana retailer
license authorizes the marihuana retailer to transfer marihuana to or from a
marihuana safety compliance facility for testing by means of a marihuana secure
transporter or as provided in these rules.
(3) A marihuana retailer
shall comply with all of the following:
(a) Sell or transfer
marihuana to an individual 21 years of age or older only after it has been
tested in accordance with these rules and bears the label required for retail
sale.
(b) Accurately enter all
transactions, current inventory, and other information into the statewide
monitoring system as required in these rules.
(c) Before selling or
transferring marihuana to an individual 21 years of age or older, verify the
individual appears to be 21 years of age or older by means of government-issued
photographic identification containing a date of birth and that the sale or
transfer will not exceed the single transaction limit in these rules. A
person shall not organize or host a temporary marihuana event unless the person
is issued a marihuana event organizer license.
R 420.105 Marihuana
microbusiness license Temporary marihuana event license; application.
Rule 5105. (1)
A marihuana microbusiness license authorizes the marihuana microbusiness to do
all of the following:
(a) Cultivate not more than
150 plants. Only mature marihuana plants are included in the plant count in
this subdivision.
(b) Process and package
marihuana.
(c) Sell or transfer
marihuana to an individual 21 years of age or older only.
(d) Transfer marihuana to a
marihuana safety compliance facility for testing.
(2) Except as otherwise
provided in R 420.304, this rule, and the MRTMA, a marihuana microbusiness
license authorizes a marihuana microbusiness to transfer marihuana from the
marihuana grower area to the marihuana processor and marihuana retailer areas
of the marihuana microbusiness and from the marihuana processor area to
marihuana grower and marihuana retailer areas of the marihuana microbusiness
without using a marihuana secure transporter if all areas of the marihuana
microbusiness enter each transfer between different areas of the marihuana
microbusiness into the statewide monitoring system.
(3) A marihuana microbusiness
shall not operate at multiple locations.
(4) A marihuana
microbusiness must accurately enter all transactions, current inventory, and
other information into the statewide monitoring system as required in these
rules.
(5) A marihuana microbusiness
may purchase or accept the transfer of marihuana seeds, tissue cultures, and
clones that do not meet the definition of marihuana plant in these rules at any
time from another grower licensed under the acts, these rules, or both. A
marihuana microbusiness shall not sell or transfer marihuana seeds, tissue
cultures, or clones received under this subrule.
(6) A marihuana
microbusiness may accept the transfer of marihuana plants only once upon
licensure from a registered primary caregiver if the registered primary
caregiver was an applicant for that marihuana microbusiness license. (1) A
temporary marihuana event license may be issued only to a marihuana event
organizer.
(2) A temporary marihuana
event license is valid for a period of at least 1 day and not more than 7 days,
which must be consecutive. The agency shall indicate on a temporary marihuana
event license how long the license is valid.
(3) An application for a
temporary marihuana event license must be submitted to the agency not less than
90 days before the first day of the temporary marihuana event.
(4) A temporary marihuana
event may be held only if the applicant is expressly approved by a municipality
to hold a temporary marihuana event at the proposed location of the event.
(5) A marihuana event
organizer who applies for a temporary marihuana event license shall apply in a
manner prescribed by the agency and provide all of the following:
(a) One of the following:
(i) If the marihuana event
organizer is an individual, the first and last name of the individual.
(ii) If the marihuana
event organizer is a business entity, the legal name of the business entity.
(b) The marihuana event
organizer license number and license number of any other marihuana establishment
license held by the applicant.
(c) The address of the
location where the temporary marihuana event will be held.
(d) The name of the
temporary marihuana event.
(e) A diagram of the
physical layout of the temporary marihuana event that clearly indicates each of
the following:
(i) Where the temporary
marihuana event will take place on the location grounds.
(ii) Entrances and exits
that will be used by participants during the event.
(iii) Areas designated for
the consumption of marihuana.
(iv) Areas where marihuana
will be sold.
(v) Areas where marihuana
will be stored.
(vi) Areas where marihuana
waste will be stored.
(vii) The specific
location of each marihuana retailer, marihuana microbusiness or class A
marihuana microbusiness who will be participating in the event.
(f) The dates and hours of
operation of the temporary marihuana event.
(g) Contact information for
the designated primary contact person for the temporary marihuana event
license, including the individual’s name, title, address, phone number, and
email address.
(h) Contact information for
a designated contact person or persons who will be onsite at the event, and
reachable by telephone during the dates and hours of operation of the temporary
marihuana event.
(i) Confirmation of
municipal compliance on an attestation form provided by the agency that
includes all of the following:
(i) The name and address
of the proposed temporary marihuana event.
(ii) The municipality
where the proposed temporary marihuana event is located.
(iii) The contact
information for the municipality including, at a minimum, all of the following:
(A) The name of the clerk
of the municipality or his or her designee.
(B) The telephone number
of the clerk of the municipality or his or her designee.
(C) The email address of
the clerk of the municipality or his or her designee.
(D) The mailing address
of the clerk of the municipality or his or her designee.
(iv) Confirmation that the
municipality has not adopted an ordinance prohibiting the proposed temporary
marihuana event.
(v) Confirmation that the
applicant is in compliance with any ordinance the municipality has adopted
relating to marihuana establishments within its jurisdiction, including zoning
regulations.
(vi) Attestation that the
applicant will report any changes that occur with municipal ordinances or
zoning regulations that relate to the proposed temporary marihuana event, any
municipal approvals, or any violations of a municipal or zoning regulation.
(vii) The date and
signature of the applicant.
(j) A list of all marihuana
retailers, marihuana microbusinesses, class A marihuana microbusinesses, and
employees who will be selling marihuana at the temporary marihuana event. If
the list of licensees and employees participating in the temporary marihuana
event changes after the application is submitted or after the temporary
marihuana event license is issued, the applicant shall submit an updated list
and an updated diagram to the agency not less than 72 hours before the event.
Licensees not on the list submitted to the agency may not participate in the
temporary marihuana event.
(k) A responsible
operations plan that includes a detailed explanation of how employees will
monitor and prevent over-intoxication, underage access to the temporary marihuana
event, the illegal sale or distribution of marihuana at the temporary marihuana
event, and any other potential criminal activity at the temporary marihuana
event.
(6) The agency or BFS may
inspect the location of a proposed temporary marihuana event.
(7) A marihuana
microbusiness license is subject to all applicable provisions in the MRTMA and
these rules related to a marihuana grower, marihuana retailer, and marihuana
processor license except for R 420.102(8).
(8) A marihuana
microbusiness may not purchase or accept a mature plant from an individual,
registered qualifying patient, or registered primary caregiver. (1) A
temporary marihuana event license shall be issued only to a marihuana event
organizer.
(2) A temporary marihuana event license is valid for a period of at least 1 day and not more than 7 days, which must be consecutive. The agency shall indicate on a temporary marihuana event license how long the license is valid.
(3) An application for a temporary marihuana event license must be submitted to the agency not less than 90 days before the first day of the temporary marihuana event.
(4) A temporary marihuana event may be held only if the applicant is expressly approved by a municipality to hold a temporary marihuana event at the proposed location of the event.
(5) A marihuana event organizer that applies for a temporary marihuana event license shall apply in a manner prescribed by the agency and provide all of the following:
(a) One of the following:
(i) If the marihuana event organizer is an individual, the first and last name of the individual.
(ii) If the marihuana event organizer is a business entity, the legal name of the business entity.
(b) The marihuana event organizer license number and license number of other marihuana establishment licenses held by the applicant, if applicable.
(c) The address of the location where the temporary marihuana event will be held.
(d) The name of the temporary marihuana event.
(e) A diagram of the physical layout of the temporary marihuana event that clearly indicates all of the following:
(i) Where the temporary marihuana event will take place on the location grounds.
(ii) Entrances and exits that will be used by participants during the event.
(iii) Areas designated for the consumption of marihuana.
(iv) Areas where marihuana will be sold.
(v) Areas where marihuana will be stored.
(vi) Areas where marihuana waste will be stored.
(vii) The specific location of each marihuana retailer, marihuana microbusiness, or class A marihuana microbusiness that will be participating in the event.
(f) The dates and hours of operation of the temporary marihuana event.
(g) Contact information for the designated primary contact person for the temporary marihuana event license, including the individual’s name, title, address, phone number, and email address.
(h) Contact information for a designated contact person or persons who will be onsite at the event and reachable by telephone during the dates and hours of operation of the temporary marihuana event.
(i) Confirmation of municipal compliance on an attestation form provided by the agency that includes all of the following:
(i) The name and address of the proposed temporary marihuana event.
(ii) The municipality where the proposed temporary marihuana event is located.
(iii) The contact information for the municipality, including, at a minimum, all of the following:
(A) The name of the clerk of the municipality or the clerk’s designee.
(B) The telephone number of the clerk of the municipality or the clerk’s designee.
(C) The email address of the clerk of the municipality or the clerk’s designee.
(D) The mailing address of the clerk of the municipality or the clerk’s designee.
(iv) Confirmation that the municipality has not adopted an ordinance prohibiting the proposed temporary marihuana event.
(v) Confirmation that the applicant is in compliance with an ordinance the municipality has adopted relating to marihuana establishments within its jurisdiction, including zoning regulations.
(vi) Attestation that the applicant will report changes that occur with municipal ordinances or zoning regulations that relate to the proposed temporary marihuana event, municipal approvals, or violations of a municipal or zoning regulation.
(vii) The date and signature of the applicant.
(j) A list of all marihuana retailers, marihuana microbusinesses, class A marihuana microbusinesses, and employees that will be selling marihuana at the temporary marihuana event. If the list of licensees and employees participating in the temporary marihuana event changes after the application is submitted or after the temporary marihuana event license is issued, the applicant shall submit an updated list and an updated diagram to the agency not less than 72 hours before the event. Licensees not on the list submitted to the agency shall not participate in the temporary marihuana event.
(k) A responsible operations plan that includes a detailed explanation of how employees will monitor and prevent over-intoxication, underage access to the temporary marihuana event, the illegal sale or distribution of marihuana at the temporary marihuana event, and any other potential criminal activity at the temporary marihuana event.
(6) The agency or the BFS may inspect the location of a proposed temporary marihuana event.
R 420.105a Class A marihuana
microbusiness license. Rescinded.
Rule 5a. (1) A class A
marihuana microbusiness license authorizes the class A marihuana microbusiness
to do all of the following:
(a) Cultivate not more than
300 plants. Only mature marihuana plants are included in the plant count in
this subdivision.
(b) Package marihuana.
(c) Purchase marihuana
concentrate and marihuana-infused products from a licensed marihuana processor.
(d) Sell or transfer
marihuana and marihuana products to an individual 21 years of age or older
only.
(e) Transfer marihuana to a
marihuana safety compliance facility for testing.
(2) Except as otherwise
provided in R 420.304, this rule, and the MRTMA, a class A marihuana
microbusiness license authorizes a class A marihuana microbusiness to transfer
marihuana only from the marihuana grower area to the marihuana retailer area of
the class A marihuana microbusiness without using a marihuana secure
transporter if all areas of the class A marihuana microbusiness enter each
transfer between different areas of the class A marihuana microbusiness into
the statewide monitoring system.
(3) A class A marihuana
microbusiness shall not operate at multiple locations.
(4) A class A marihuana
microbusiness shall accurately enter all transactions, current inventory, and
other information into the statewide monitoring system as required in these
rules.
(5) A class A marihuana
microbusiness may purchase or accept the transfer of marihuana seeds, tissue
cultures, clones, or marihuana plants at any time from another grower licensed
under the acts, these rules, or both. A class A marihuana microbusiness shall
not sell or transfer marihuana seeds, tissue cultures, or clones received under
this subrule.
(6) A class A marihuana
microbusiness shall not purchase or receive marihuana from a licensed marihuana
processor.
(7) A class A marihuana
microbusiness license is subject to all applicable provisions in the MRTMA and
these rules related to a marihuana grower and marihuana retailer license except
for R 420.102(8).
(8) A class A marihuana
microbusiness may accept the transfer of marihuana plants only once upon
licensure from a registered primary caregiver if the registered primary
caregiver was an applicant for that class A marihuana microbusiness license.
(9) A class A marihuana
microbusiness may not purchase or accept a mature plant from an individual,
registered qualifying patient, or registered primary caregiver, except as
authorized under subdivision (5) and subdivision (8) of this rule.
R 420.106 Marihuana secure
transporter license Temporary marihuana event license; fee.
Rule 6106. (1)
A marihuana secure transporter license authorizes the licensee to store and
transport marihuana and money associated with the purchase or sale of marihuana
between marihuana establishments for a fee upon request of a person with legal
custody of that marihuana or money. It does not authorize transport to a
registered qualifying patient or registered primary caregiver. If a marihuana
secure transporter has its primary place of business in a municipality that has
not adopted an ordinance under section 6 of the MRTMA, MCL 333.27956,
prohibiting marihuana establishments, the marihuana secure transporter may
travel through any municipality.
(2) A marihuana secure
transporter shall accurately enter all transactions, current inventory, and
other information into the statewide monitoring system as required in these
rules.
(3) A marihuana secure
transporter shall comply with all of the following:
(a) Each driver
transporting marihuana must have a chauffeur's license issued by this state.
(b) Each vehicle must be
operated with a 2-person crew, with at least 1 individual remaining with the
vehicle at all times during the transportation of marihuana.
(c) A route plan and
manifest must be entered into the statewide monitoring system, and a copy must
be carried in the transporting vehicle and presented to a law enforcement
officer upon request.
(d) The marihuana must be
transported in 1 or more sealed containers and not be accessible while in
transit.
(e) A secure transporting
vehicle may not bear markings or other indication that it is carrying marihuana
or a marihuana-infused product.
(f) A secure transport
vehicle may be stored at a location that is not the primary place of business
of the secure transporter if the vehicle does not contain marihuana products
and the address of storage is reported to the agency.
(4) A marihuana secure
transporter is subject to administrative inspection by a law enforcement
officer at any point during the transportation of marihuana to determine
compliance with the MRTMA and these rules.
(5) A marihuana secure
transporter may transfer marihuana and marihuana product to another marihuana
secure transporter for the purpose of completing a transfer between marihuana
establishments as long as all of the following are complied with:
(a) The transfer of
marihuana or marihuana product takes place at a location that is licensed as a
marihuana secure transporter.
(b) The transfer of product
between marihuana secure transporters is on the manifest in the statewide monitoring
system.
(c) The transfer of product
between marihuana secure transporters occurs as a result of a request by the
marihuana establishment that has sent the product to another marihuana
establishment. (1) A marihuana event organizer that applies for a
temporary marihuana event license shall submit a license fee that consists of
both of the following:
(a) A $500.00 fee for each marihuana retailer, marihuana microbusiness, and class A marihuana microbusiness authorized to sell marihuana at the event.
(b) A $500.00 fee for each day of the temporary marihuana event.
(2) If a marihuana retailer, marihuana microbusiness, or class A marihuana microbusiness scheduled to participate in a temporary marihuana event withdraws from the event before the first day of the event, the marihuana event organizer may request a refund of the fee paid under subrule (1)(a) of this rule for that licensee.
(3) The agency shall not issue a temporary marihuana event license until all of the following have been met:
(a) An applicant meets the requirements of R 420.105.
(b) The agency determines that the applicant is qualified to receive a temporary marihuana event license.
(c) The applicant pays the fee required under this rule.
R 420.107 Marihuana safety
compliance facility license Temporary marihuana event; operations.
Rule 7107. (1)
A marihuana safety compliance facility license authorizes the marihuana safety
compliance facility to do all of the following without using a marihuana secure
transporter:
(a) Take marihuana from,
test marihuana for, and return marihuana to only a licensed marihuana
establishment.
(b) Collect a random sample
of marihuana at the marihuana establishment of a marihuana grower, marihuana
processor, marihuana retailer, marihuana microbusiness, or class A marihuana
microbusiness for testing.
(c) Receive marihuana from
and test marihuana for an individual 21 years of age or older. The marihuana
safety compliance facility shall keep documentation for proof of age.
(2) A marihuana safety
compliance facility must be accredited by an entity approved by the agency
within 1 year after the date the marihuana safety compliance facility license
is issued or have previously provided drug testing services to this state, or
this state's court system, and be a vendor in good standing in regard to those
services. The agency may grant a variance from this requirement upon a finding
that the variance is necessary to protect and preserve the public health,
safety, or welfare.
(3) A marihuana safety
compliance facility that has not achieved accreditation as required under
subrule (2) of this rule may not perform safety compliance testing or research
and development testing for a licensed marihuana establishment and may not
charge or collect any fee for testing performed until compliance with subrule
(2) of this rule is demonstrated to the agency.
(4) A marihuana safety
compliance facility shall comply with all of the following:
(a) Perform safety tests to
certify that marihuana is reasonably free of known contaminants in compliance
with the standards established by the agency.
(b) Use validated test
methods to perform all safety tests and to determine tetrahydrocannabinol
(THC), tetrahydrocannabinol acid (THC-A), cannabidiol (CBD), and cannabidiol
acid (CBD-A) concentrations.
(c) Perform other tests
necessary to determine compliance with good manufacturing practices as
prescribed in these rules.
(d) Accurately enter all
transactions, current inventory, and other information into the statewide
monitoring system as required in these rules.
(e) Have a secured
laboratory space that cannot be accessed by the general public.
(f) Retain and employ at
least 1 laboratory manager with a relevant advanced degree in a medical or
laboratory science. A laboratory manager is responsible for the following
duties, including, but not limited to:
(i) Ensure tests are
conducted in accordance with R 420.305.
(ii) Ensure test results
are accurate and valid.
(iii) Oversee day-to-day
operations.
(iv) Validate reporting
requirements in the statewide monitoring system. (1) A marihuana event
organizer that is issued a temporary marihuana event license shall do all of
the following for the temporary marijuana event:
(a) Hire or contract for licensed security personnel to provide security services at the temporary marihuana event. All security personnel hired or contracted for by the marihuana event organizer shall be 21 years of age or older and present during the dates and hours of operation of the temporary marihuana event. The security personnel shall not engage in the consumption of marihuana before or during the event.
(b) Post a legible sign, not less than 8-½ by 11 inches in size reading, “No Persons Under 21 Allowed” at or near each public entrance to an area where the sale or consumption of marihuana is allowed. The lettering of the sign must be not less than 1 inch in height.
(c) Ensure that access to the event is restricted to individuals 21 years of age or older.
(d) Ensure that marihuana sales or consumption is not visible from a public place outside the secured location of the temporary marihuana event.
(e) Ensure that all rules and requirements for the onsite sale of marihuana are followed.
(f) Ensure that marihuana waste remaining at the location of a temporary marihuana event after the conclusion of the event is collected and disposed of in accordance with the requirements of R 420.211.
(2) The agency may require the marihuana event organizer and all participants to cease operations if in the opinion of the agency or law enforcement the event poses an imminent threat to the public health, safety, and welfare, or if the agency provides notification under subrule (3) of this rule. On notification from the agency that the event must cease operations, the marihuana event organizer shall immediately stop the event and all participants must be removed from the premises.
(3) On notification from the agency, the marihuana event organizer shall immediately expel from the event a person selling marihuana without a marihuana retailer, marihuana microbusiness, or class A marihuana microbusiness license. The marihuana event organizer or their representative shall remain with the person being expelled from the premises until the person vacates the premises. If the person does not vacate the premises, the agency may inform the marihuana event organizer that the event must cease operations.
PART 2. LICENSEES
UNDER THE MEDICAL MARIHUANA FACILITIES LICENSING ACT
R 420.108 Grower license Temporary
marihuana event sales.
Rule 8108. (1)
A grower license authorizes the grower to grow not more than the following
number of marihuana plants under the indicated license class for each license
the grower holds in that class:
(a) Class A – 500 marihuana
plants.
(b) Class B – 1,000
marihuana plants.
(c) Class C – 1,500
marihuana plants.
(2) For the purposes of this
rule, a marihuana plant that meets the definition of a plant in the MMFLA is
included in the plant count in subrule (1) of this rule.
(3) Except as otherwise
provided in this subrule, a grower license authorizes sale of marihuana and
marihuana plants to a grower only by means of a secure transporter. A grower
license authorizes the sale or transfer of seeds, seedlings, or tissue cultures
to a grower from a registered primary caregiver or another grower without using
a secure transporter.
(4) A grower license
authorizes a grower to transfer marihuana without using a secure transporter to
a processor or provisioning center if both of the following are met:
(a) The processor or
provisioning center occupies the same location as the grower and the marihuana
is transferred using only private real property without accessing public
roadways.
(b) The grower enters each
transfer into the statewide monitoring system.
(5) A grower license
authorizes sale of marihuana, other than seeds, seedlings, tissue cultures, and
cuttings, to a processor or a provisioning center.
(6) Except as otherwise
provided in subrules (2) and (3) of this rule and section 505 of the MMFLA, MCL
333.27505, a grower license authorizes the grower to transfer marihuana only by
means of a secure transporter.
(7) To be eligible for a
grower license, the applicant and each investor in the grower must not have an
interest in a secure transporter or safety compliance facility.
(8) A grower shall
accurately enter all transactions, current inventory, and other information
into the statewide monitoring system as required in the MMFLA, these rules, and
the marihuana tracking act.
(89) A grower license does
not authorize the grower to operate in an area unless the area is zoned for
industrial or agricultural uses or is unzoned and otherwise meets the
requirements established in section 205(1) of the medical marihuana facilities
licensing act, MCL 333.27205.
(10) A grower may not
purchase or accept a mature plant from an individual, registered qualifying
patient, or registered primary caregiver.
(11) A grower may not accept
marihuana or marihuana product back from a processor or provisioning center
once it has been received into the processor or provisioning center’s inventory
in the statewide monitoring system, without obtaining written approval from the
agency. (1) A person shall not sell marihuana at a temporary marihuana
event unless the person is a marihuana retailer, marihuana microbusiness, or
class A marihuana microbusiness.
(2) A marihuana retailer, marihuana microbusiness, or class A marihuana microbusiness selling or transferring marihuana at a temporary marihuana event shall verify the identity and age of the marihuana customer in compliance with R 420.501.
(3) A marihuana retailer, marihuana microbusiness, or class A marihuana microbusiness shall sell marihuana only within their specifically assigned area identified in the diagram required in R 420.105(5)(e).
(4) A marihuana retailer, marihuana microbusiness, or class A marihuana microbusiness shall prominently display their state license number within plain sight of the public.
(5) All sales at a temporary marihuana event must occur at the location and during the dates and times of the temporary marihuana event.
(6) Except for small amounts of marihuana used for display, all marihuana for sale at a temporary marihuana event must be stored in a secure, locked container that is not accessible to the public. A marihuana retailer, marihuana microbusiness, or class A marihuana microbusiness shall not leave marihuana unattended within their specifically assigned area.
(7) A marihuana retailer, marihuana microbusiness, or class A marihuana microbusiness shall not transport more than 15 ounces of marihuana or 60 grams of marihuana concentrate at one time to or from a temporary marihuana event. A marihuana retailer, marihuana microbusiness, or class A marihuana microbusiness shall use a marihuana secure transporter to transport more marihuana than is allowed under this subrule.
(8) In addition to complying with all other requirements in the MRTMA and these rules for the sale and tracking of marihuana, a licensee selling marihuana at a temporary marihuana event shall comply with both of the following:
(a) Identify marihuana from the licensee’s inventory at the marihuana establishment that will be transported for sale at the event using a marihuana secure transporter or an agent of the licensee to the temporary marihuana event.
(b) Dispose of marihuana waste and marihuana plant waste in the possession of the licensee or in the licensee’s specifically assigned area at the conclusion of the temporary marihuana event.
R 420.109 Processor license
Marihuana educational research license.
Rule 9109. (1)
A processor license authorizes the processor to purchase marihuana only from a
grower and sell marihuana-infused products or marihuana only to a provisioning
center or another processor.
(2) Except as otherwise
provided in section 505 of the medical marihuana facilities licensing act, MCL
333.27505, and this subrule, a processor license authorizes the processor to
transfer marihuana only by means of a secure transporter. A processor license
authorizes a processor to transfer marihuana without using a secure transporter
to a grower or provisioning center if both of the following are met:
(a) The grower or
provisioning center occupies the same location as the processor and the
marihuana is transferred using only private real property without accessing
public roadways.
(b) The processor
accurately enters each transfer into the statewide monitoring system.
(3) To be eligible for a
processor license, the applicant and each investor in the processor may not
have an interest in a secure transporter or safety compliance facility.
(4) A processor shall enter
all transactions, current inventory, and other information into the statewide
monitoring system as required in the MMFLA, these rules, and the marihuana
tracking act.
(5) A processor may not
accept marihuana or marihuana product back from a provisioning center once it
has been received into the provisioning center’s inventory in the statewide
monitoring system, without obtaining written approval from the agency. (1)
A person that holds a marihuana educational research license may do all of the
following:
(a) Obtain marihuana from a marihuana establishment.
(b) Process marihuana.
(c) Perform research on marihuana.
(d) Dispose of marihuana.
(e) Other research activity allowed by the United States Drug Enforcement Administration (DEA) that does not conflict with the MRTMA or these rules.
(2) A person that holds a marihuana educational research license shall apply for the necessary registration from the DEA. A licensee shall provide proof of registration to the agency before engaging in licensed activity.
(3) An application for a marihuana educational research license must be made in a manner prescribed by the agency. A complete application for a marihuana educational research license must contain the information required in these rules and information regarding the marihuana educational research license, including, at a minimum, all of the following:
(a) A research plan, including, at a minimum, all of the following:
(i) A written plan for documenting all individuals who will have access to the location and marihuana.
(ii) A detailed description and documentation of affiliation with a degree or certificate program offered by an institution of higher learning accredited by the Higher Learning Commission, which is an institutional accreditor recognized by the United States Department of Education and the Council for Higher Education Accreditation to accredit degree-granting colleges and universities.
(iii) A brief description of the research that will be conducted.
(iv) A written plan to ensure secure delivery and receipt of marihuana at the licensed location.
(v) A written plan to ensure the safe storage of marihuana at the licensed location.
(vi) A written plan for the tracking of marihuana quantities at the licensed location.
(vii) A written plan for the disposal of marihuana.
(viii) A floor plan of the location.
(b) Confirmation of municipal compliance on an attestation form provided by the agency that includes all of the following:
(i) The name and address of the proposed marihuana educational research license.
(ii) The municipality where the proposed marihuana educational research license is located.
(iii) The contact information for the municipality, including, at a minimum, all of the following:
(A) The name of the clerk of the municipality or the clerk’s designee.
(B) The telephone number of the clerk of the municipality or the clerk’s designee.
(C) The email address of the clerk of the municipality or the clerk’s designee.
(D) The mailing address of the clerk of the municipality or the clerk’s designee.
(iv) Confirmation that the municipality has not adopted an ordinance prohibiting the proposed marihuana educational research license.
(v) Confirmation that the applicant is in compliance with an ordinance the municipality has adopted relating to marihuana establishments within its jurisdiction, including zoning regulations.
(vi) Attestation that the applicant will report changes that occur with municipal ordinances or zoning regulations that relate to the proposed marihuana educational research license, municipal approvals, or violations of a municipal or zoning regulation.
(vii) The date and signature of the applicant.
(c) A certificate of use and occupancy under R 420.210 in which the authorized activities of the marihuana educational research license are to be conducted.
(d) Other documents required by the agency that are not inconsistent with the acts and these rules.
(4) An applicant for a marihuana educational research license shall provide notification and report to the agency in writing within 24 hours of when the applicant became aware of, or should have become aware of, all of the following:
(a) Loss of institutional affiliation.
(b) Loss of institutional accreditation.
(c) Loss or restriction of DEA registration.
(d) Theft, loss, diversion, or criminal activity at the licensed location.
(5) A marihuana educational research licensee shall not sell or transfer marihuana to a marihuana establishment or to a marihuana customer.
(6) A marihuana educational research licensee shall not allow marihuana to be consumed or sampled on the licensed premises unless the licensee is approved to engage in a research study under R 420.407(8) or the licensee obtains express written permission from the agency.
R 420.110 Secure transporter
license Class A marihuana microbusiness.
Rule 10110. (1)
A secure transporter license authorizes the licensee to store and transport
marihuana and money associated with the purchase or sale of marihuana between
marihuana facilities for a fee upon request of a person with legal custody of
that marihuana or money. It does not authorize transport of marihuana products
to a registered qualifying patient or registered primary caregiver. If a
secure transporter has its primary place of business in a municipality that has
adopted an ordinance under section 205 of the MMFLA, MCL 333.27205, authorizing
the marihuana facility, the secure transporter may travel through any
municipality.
(2) To be eligible for a
secure transporter license, the applicant and each investor with an interest in
the secure transporter may not have an interest in a grower, processor,
provisioning center, or safety compliance facility and may not be a registered
qualifying patient or registered primary caregiver.
(3) A secure transporter
shall accurately enter all transactions, current inventory, and other
information into the statewide monitoring system as required in the MMFLA,
these rules, and the marihuana tracking act.
(4) A secure transporter
shall comply with all of the following:
(a) Each driver
transporting marihuana must have a chauffeur’s license issued by this state.
(b) Each employee who has
custody of marihuana or money that is related to a marihuana transaction shall
not have been convicted of or released from incarceration for a felony under
the laws of this state, any other state, or the United States within the past 5
years or have been convicted of a misdemeanor involving a controlled substance
within the past 5 years.
(c) Each vehicle must be
operated with a 2-person crew with at least 1 individual remaining with the
vehicle at all times during the transportation of marihuana.
(d) A route plan and
manifest must be entered into the statewide monitoring system, and a copy must
be carried in the transporting vehicle and presented to a law enforcement
officer upon request.
(e) The marihuana must be
transported in 1 or more sealed containers and not be accessible while in
transit.
(f) A secure transporting
vehicle may not bear markings or other indication that it is carrying marihuana
or a marihuana-infused product.
(g) A secure transport
vehicle may be stored at a location that is not the primary place of business
of the secure transporter if the vehicle does not contain marihuana products
and the address of storage is reported to the agency.
(5) A secure transporter is
subject to administrative inspection by a law enforcement officer at any point
during the transportation of marihuana to determine compliance with the MMFLA.
(6) A secure transporter may
transfer marihuana and marihuana product to another secure transporter for the
purpose of completing a transfer between medical marihuana facilities as long
as all of the following are complied with:
(a) The transfer of
marihuana or marihuana product takes place at a location that is licensed as a
secure transporter.
(b) The transfer of product
between secure transporters is on the manifest in the statewide monitoring
system.
(c) The transfer of product
between secure transporters occurs as a result of a request by the medical
marihuana facility that has sent the product to another medical marihuana
facility. (1) A class A marihuana microbusiness may do all of the
following:
(a) Cultivate not more than 300 mature plants.
(b) Process and package marihuana.
(c) Purchase marihuana concentrate and marihuana-infused products from a marihuana processor.
(d) Sell or transfer marihuana to an individual 21 years of age or older.
(e) Sell or transfer harvested marihuana flower to a marihuana grower, marihuana processor, or marihuana retailer.
(f) Transfer marihuana to a marihuana safety compliance facility for testing.
(g) Purchase or receive marihuana seeds, tissue cultures, clones, or immature plants from a marihuana grower.
(h) Accept the transfer of marihuana plants only once, at the time of licensure, from a registered primary caregiver if the registered primary caregiver was an applicant for that class A marihuana microbusiness license.
(2) A class A marihuana microbusiness shall operate the cultivation, processing, and sales areas of the business in compliance with the operations requirements of a marihuana grower, marihuana processor, and marihuana retailer, except that a class A microbusiness is not required to be located in an area that is zoned for industrial or agricultural uses.
(3) A class A marihuana microbusiness shall not do any of the following:
(a) Except as provided in subrule (1)(h) of this rule, purchase or receive a mature plant from a marihuana business, individual, registered qualifying patient, or registered primary caregiver.
(b) Sell or transfer marihuana seeds, tissue cultures, or clones received under subrule (1) of this rule.
(4) A person that holds an ownership interest in, or is a managerial employee of, a class A marihuana microbusiness shall not hold an ownership interest in, or be a managerial employee of, another marihuana business.
R 420.111 Provisioning center
license. Rescinded.
Rule 11. (1) A provisioning
center license authorizes the purchase or transfer of marihuana only from a
grower or processor and sale or transfer to only a registered qualifying
patient or registered primary caregiver. Except as otherwise provided in
section 505 of the MMFLA, MCL 333.27505, and this subrule, all transfers of
marihuana to a provisioning center from a separate marihuana facility must be
by means of a secure transporter. A transfer of marihuana to a provisioning
center from a marihuana facility that occupies the same location as the
provisioning center does not require a secure transporter if the marihuana is
transferred to the provisioning center using only private real property without
accessing public roadways.
(2) A provisioning center
license authorizes the provisioning center to transfer marihuana to or from a
safety compliance facility for testing by means of a secure transporter or as
provided in section 505 of the MMFLA, MCL 333.27505.
(3) To be eligible for a
provisioning center license, the applicant and each investor in the
provisioning center may not have an interest in a secure transporter or safety
compliance facility.
(4) A provisioning center
shall comply with all of the following:
(a) Sell or transfer
marihuana to a registered qualifying patient or registered primary caregiver
only after it has been tested and bears the label required for retail sale.
(b) Accurately enter all
transactions, current inventory, and other information into the statewide
monitoring system as required in the MMFLA, these rules, and the marihuana
tracking act.
(c) Before selling or
transferring marihuana to a registered qualifying patient or to a registered
primary caregiver on behalf of a registered qualifying patient, inquire of the
statewide monitoring system to determine whether the patient and, if
applicable, the caregiver, hold a valid, current, unexpired, and unrevoked
registry identification card and that the sale or transfer will not exceed the
daily and monthly purchasing limit established by the agency under the MMFLA.
R 420.112 Safety compliance
facility license; exception for industrial hemp. Rescinded.
Rule 12. (1) In addition to
transfer and testing as authorized in section 203 of the MMFLA, MCL 333.27203,
a safety compliance facility license authorizes the safety compliance facility
to do all of the following without using a secure transporter:
(a) Take marihuana from,
test marihuana for, and return marihuana to only a marihuana facility.
(b) Collect a random sample
of marihuana at the marihuana facility of a grower, processor, or provisioning
center for testing.
(2) A safety compliance
facility must be accredited by an entity approved by the agency by 1 year after
the date the license is issued or have previously provided drug testing
services to this state or this state’s court system and be a vendor in good
standing in regard to those services. The agency may grant a variance from
this requirement upon a finding that the variance is necessary to protect and
preserve the public health, safety, or welfare.
(3) A safety compliance
facility that has not achieved accreditation as required by subrule (2) of this
rule may not perform safety compliance testing or research and development testing
for a licensed marihuana facility and may not charge or collect any fee for
testing performed until compliance with subrule (2) of this rule is
demonstrated to the agency.
(4) To be eligible for a
safety compliance facility license, the applicant, and each investor with any
interest in the safety compliance facility must not have an interest in a
grower, secure transporter, processor, or provisioning center.
(5) A safety compliance
facility shall comply with all of the following:
(a) Perform tests to
certify that marihuana is reasonably free from chemical residues such as
fungicides and insecticides.
(b) Use validated methods
for all testing required by the agency.
(c) Perform tests that
determine whether marihuana complies with the standards the agency establishes.
(d) Perform additional
tests necessary to determine compliance with any other good manufacturing
practices as prescribed in these rules.
(e) Accurately enter all
transactions, current inventory, and other information into the statewide
monitoring system as required in the MMFLA, these rules, and the marihuana
tracking act.
(f) Have a secured
laboratory space that cannot be accessed by the general public.
(g) Retain and employ at
least 1 laboratory manager with a relevant advanced degree in a medical or
laboratory science. A laboratory manager shall be is responsible for the
following duties, including, but not limited to:
(i) Ensure tests are
conducted in accordance with R 420.305.
(ii) Ensure test results
are accurate and valid.
(iii) Oversee day-to-day
operations.
(iv) Validate reporting
requirements in the statewide monitoring system.
(6) A safety compliance
facility is not prohibited from taking or receiving industrial hemp for testing
purposes and testing the industrial hemp pursuant to the industrial hemp
research and development act.
PART 3. AGREEMENTS
R 420.112a Licensing,
management, or other agreements. Rescinded.
Rule 12a. (1) A licensee may
contract with another party to use the other party’s intellectual property or
for the other party to provide management or other services necessary for the
operation of the licensee pursuant to a licensing or management agreement
approved by the agency.
(2) A licensee shall submit
a complete, unredacted, signed copy of the licensing, management, or other
agreement to the agency for review and approval prior to performance under the
agreement. Approval by the agency indicates an agency determination that it
does not appear based upon the information provided that the other party meets
the definition of applicant.
(3) The agreement must
include, but is not limited to, all of the following:
(a) All payment terms
between the parties. Licensing agreements must also include a requirement that
all payments made to the other party pursuant to the licensing agreement must
be made by the licensee and not by any other licensee purchasing the marihuana
product.
(b) Terms specifically
naming and clearly defining any service to be performed pursuant to the
agreement.
(c) Terms specifically
requiring all business operations related to the production, sales, invoicing,
and payment for marihuana products sold pursuant to a licensing agreement must
be performed by the licensee.
(d) A statement indicating
that the agreement contains the entire agreement of the parties.
(4) Terms that may indicate
the other party meets the definition of applicant and is thereby subject to
application requirements, include, but are not limited to, the following:
(a) Any term or condition
that would allow the other party to exercise control over or participate in the
management of the licensee. This does not include control or terms specific to
a licensing agreement such as production method or packaging requirements.
(b) Any term or condition
that would allow the other party to receive more than 10% of the gross or net
profit from the licensee during any full or partial calendar or fiscal year.
(c) Any term or condition
that would result in the other party obtaining an ownership interest in the
marihuana business or taking possession or ownership of marihuana product owned
by the marihuana business.
(d) Any term or condition
that would require the licensee to name the other party as a named insured on
any insurance policy required to be maintained as a condition of a marihuana
license.
(5) Any term or condition
that would allow the licensee to use an assumed name or doing business as in
the operation of the licensee is not operative unless the licensee has complied
with the requirements of 1907 PA 101, MCL 445.1 to 445.5.
(6) The licensee shall
provide any other information requested by the agency that is not inconsistent
with the acts and these rules.
R 420.113 Severability. Rescinded.
Rule 13. If any rule or
subrule of these rules, in whole or in part, is found to be invalid by a court
of competent jurisdiction, such decision will not affect the validity of the
remaining portion of these rules.
DEPARTMENT OF
LICENSING AND REGULATORY AFFAIRS
MARIJUANA
REGULATORY AGENCY
MARIHUANA
OPERATIONS
(By authority conferred on the
executive director of the marijuana regulatory agency by section 206 of the
medical marihuana facilities licensing act, 2016 PA 281, MCL 333.27206,
sections 7 and 8 of the Michigan Regulation and Taxation of Marihuana Act, 2018
IL 1, MCL 333.27957 and 333.27958, and Executive Reorganization Order No.
2019-2, MCL 333.27001)
PART 4. MARIHUANA OPERATIONS
R 420.201 Definitions Statewide
monitoring system; requirements.
Rule 1201. (1)
As used in these rules:
(a) “Acts” refers to the
medical marihuana facilities licensing act, 2016 PA 281, MCL 333.27101 to
333.27801, and the Michigan Regulation and Taxation of Marihuana Act, 2018 IL
1, MCL 333.27951 to 333.27967, when applicable.
(b) “Administrative hold”
means a status given to marihuana product by the agency during an investigation
into alleged violations of the acts and these rules. This status includes no
sale or transfer of the marihuana product until the hold is lifted.
(c) “Agency” means the
marijuana regulatory agency.
(d) "Applicant"
means a person who applies for a marihuana license, subject to paragraphs (i)
and (ii) of this subdivision:
(i) For purposes of this
definition, an applicant includes a managerial employee of the applicant, a
person holding a direct or indirect ownership interest of more than 10% in the
applicant, and the following for each type of applicant:
(A) For an individual or
sole proprietorship: the proprietor and spouse.
(B) For a partnership and
limited liability partnership: all partners and their spouses.
(C) For a limited
partnership and limited liability limited partnership: all general and limited
partners, not including a limited partner holding a direct or indirect
ownership interest of 10% or less who does not exercise control over or
participate in the management of the partnership, and their spouses.
(D) For a limited
liability company: all members and managers, not including a member holding a
direct or indirect ownership interest of 10% or less who does not exercise
control over or participate in the management of the company, and their
spouses.
(E) For a privately held
corporation: all corporate officers or persons with equivalent titles and their
spouses, all directors and their spouses, all stockholders, not including those
holding a direct or indirect ownership interest of 10% or less, and their
spouses.
(F) For a publicly held
corporation: all corporate officers or persons with equivalent titles and their
spouses, all directors and their spouses, all stockholders, not including those
holding a direct or indirect ownership interest of 10% or less, and their
spouses.
(G) For a multilevel
ownership enterprise: any entity or person that receives or has the right to
receive more than 10% of the gross or net profit from the enterprise during any
full or partial calendar or fiscal year.
(H) For a nonprofit
corporation: all individuals and entities with membership or shareholder rights
in accordance with the articles of incorporation or the bylaws and their
spouses.
(I) For a trust:
trustees, any individual or body able to control and direct the affairs of the
trust, and any beneficiary who receives or has the right to receive more than
10% of the gross or net profit of the trust during any full or partial calendar
or fiscal year and their spouses.
(ii) For purposes of this
definition, an applicant does not include:
(A) A person who provides
financing to an applicant or licensee under a bona fide financing agreement at
a reasonable interest rate.
(B) A franchisor who
grants a franchise to an applicant, if the franchisor does not have the right
to receive royalties based upon the sale of marihuana or marihuana-infused
products by the applicant who is a franchisee. Nothing in this subrule shall
be construed to preclude a franchisor from charging an applicant who is a
franchisee a fixed fee. As used in this definition, the terms “franchise,”
“franchisor,” and “franchisee” have the meanings set forth in section 2 of the
franchise investment law, 1974 PA 269, MCL 445.1502.
(C) A person receiving
reasonable payment for rent on a fixed basis under a bona fide lease or rental
obligation.
(D) A person receiving
reasonable payment under a licensing agreement or contract approved by the
agency concerning the licensing of intellectual property including, but not
limited to, brands and recipes.
(e) “Batch” means all
marihuana product of the same variety that has been processed together and
exposed to substantially similar conditions throughout processing.
(f) “Building” means a
combination of materials forming a structure affording a facility, an
establishment, or shelter for use or occupancy by individuals or property. Building
includes a part or parts of the building and all equipment in the building. A
building does not include a building incidental to the use for agricultural
purposes of the land on which the building is located.
(g) “Bureau of fire
services” or “BFS” means the bureau of fire services in the department of
licensing and regulatory affairs.
(h) “Common ownership”
means 2 or more state licenses or 2 or more equivalent licenses held by 1
person under the Michigan Regulation and Taxation of Marihuana Act.
(i) “Cultivator” refers to
both a grower under the medical marihuana facilities licensing act and a
marihuana grower under the Michigan Regulation and Taxation of Marihuana Act.
(j) “Designated consumption
establishment” means a commercial space that is licensed by the agency and
authorized to permit adults 21 years of age and older to consume marihuana
products at the location indicated on the state license.
(k) “Employee” means a
person performing work or service for compensation. “Employee” does not
include individuals providing trade or professional services who are not
normally engaged in the operation of a marihuana business.
(l) “Equivalent licenses”
means any of the following held by a person:
(i) A marihuana grower
license of any class issued under the Michigan Regulation and Taxation of
Marihuana Act and a grower license, of any class, issued under the medical
marihuana facilities licensing act.
(ii) A marihuana processor
license issued under the Michigan Regulation and Taxation of Marihuana Act and
a processor license issued under the medical marihuana facilities licensing
act.
(iii) A marihuana retailer
license issued under the Michigan Regulation and Taxation of Marihuana Act and
a provisioning center license issued under the medical marihuana facilities
licensing act.
(iv) A marihuana secure
transporter license issued under the Michigan Regulation and Taxation of
Marihuana Act and a secure transporter license issued under the medical
marihuana facilities licensing act.
(v) A marihuana safety
compliance facility license issued under the Michigan Regulation and Taxation
of Marihuana Act and a safety compliance facility license issued under the
medical marihuana facilities licensing act.
(m) “Final form” means the
form a marihuana product is in when it is available for sale by a marihuana
sales location, not including consumer packaging. For marihuana products
intended for inhalation, final form means the marihuana concentrate in an
e-cigarette or a vaping device.
(n) "Immature plant”
means a nonflowering marihuana plant that is no taller than 8 inches from the
growing or cultivating medium and no wider than 8 inches produced from a
cutting, clipping, tissue culture, or seedling that is in a growing or
cultivating medium or in a growing or cultivating container.
(o) “Inactive ingredients”
means binding materials, dyes, preservatives, flavoring agents, and any other
ingredient that is not derived from the plant Cannabis sativa L.
(p) “Laboratory” refers to
both a safety compliance facility under the medical marihuana facilities
licensing act and a marihuana safety compliance facility under the Michigan
Regulation and Taxation of Marihuana Act.
(r) “Marihuana business”
refers to both a marihuana facility under the medical marihuana facilities
licensing act and a marihuana establishment under the Michigan Regulation and
Taxation of Marihuana Act.
(s) “Marihuana business
location plan” means a marihuana facility plan under the medical marihuana
facilities licensing act, or a marihuana establishment plan under the Michigan
Regulation and Taxation of Marihuana Act, or both.
(t) “Marihuana customer”
refers to a registered qualifying patient or registered primary caregiver under
the medical marihuana facilities licensing act, or an individual 21 years of
age or older under the Michigan Regulation and Taxation of Marihuana Act, or
both.
(u) “Marihuana
establishment” means a marihuana grower, marihuana safety compliance facility,
marihuana processor, marihuana microbusiness, marihuana retailer, marihuana
secure transporter, or any other type of marihuana-related business licensed by
the agency under the Michigan Regulation and Taxation of Marihuana Act.
(v) “Marihuana event
organizer” means a person licensed to apply for a temporary marihuana event
license under these rules.
(w) “Marihuana facility”
means a location at which a licensee is licensed to operate under the medical
marihuana facilities licensing act.
(x) “Marihuana license”
means a state operating license issued under the medical marihuana facilities
licensing act, or a state license issued under the Michigan Regulation and
Taxation of Marihuana Act, or both.
(y) “Marihuana product”
means marihuana or a marihuana-infused product, or both, as those terms are
defined in the acts unless otherwise provided for in these rules.
(z) “Marihuana sales
location” refers to a provisioning center under the medical marihuana
facilities licensing act or a marihuana retailer, or marihuana microbusiness,
or class A marihuana microbusiness under the Michigan Regulation and Taxation
of Marihuana Act, or both.
(aa) “Marihuana tracking
act” means the marihuana tracking act, 2016 PA 282, MCL 333.27901 to 333.27904.
(bb) “Marihuana
transporter” means a secure transporter under the medical marihuana facilities
licensing act or a marihuana secure transporter under the Michigan Regulation
and Taxation of Marihuana Act, or both.
(cc) “Medical marihuana
facilities licensing act” or “MMFLA” means the medical marihuana facilities
licensing act, 2016 PA 281, MCL 333.27101 to 333.27801.
(dd) “Michigan Medical
Marihuana Act” means the Michigan Medical Marihuana Act, 2008 IL 1, MCL
333.26421 to 333.26430.
(ee) “Michigan Regulation
and Taxation of Marihuana aAct” or “MRTMA” means the Michigan Regulation and
Taxation of Marihuana Act, 2018 IL 1, MCL 333.27951 to 333.27967.
(ff) “Producer” refers to
both a processor under the medical marihuana facilities licensing act and a
marihuana processor under the Michigan Regulation and Taxation of Marihuana
Act.
(gg) “Proposed marihuana
business” means a proposed marihuana establishment under the Michigan
Regulation and Taxation of Marihuana Act or a proposed marihuana facility under
the medical marihuana facilities licensing act, or both.
(hh) “Records of
formulation” means the documentation that includes at a minimum: the
ingredients, recipe, processing in order to be shelf stable, Certificates of
Analysis for any ingredient used, and description of the process in which all
ingredients are combined to produce a final form.
(jj) “These rules” means
the administrative rules promulgated by the agency under the authority of the
medical marihuana facilities licensing act, the marihuana tracking act, the
Michigan Regulation and Taxation of Marihuana Act, and Executive Reorganization
Order No. 2019-2, MCL 333.27001.
(kk) “Same location” means
separate marihuana licenses that are issued to multiple marihuana businesses
that are authorized to operate at a single property but with separate business
suites, partitions, or addresses.
(ll) “Source documentation”
means an original document that contains the details of a marihuana business
transaction.
(mm) “Stacked license”
means more than 1 marihuana license issued to a single licensee to operate as a
Class C grower as specified in each license at a marihuana business under the
medical marihuana facilities licensing act, or under the Michigan Regulation
and Taxation of Marihuana Act, or both.
(nn) “Tag” or “RFID tag”
means the unique identification number or Radio Frequency Identification (RFID)
issued to a licensee by the statewide monitoring system for tracking,
identifying, and verifying marihuana plants, marihuana products, and packages
of marihuana product in the statewide monitoring system.
(oo) “Temporary marihuana
event license” means a state license held by a marihuana event organizer under
the Michigan Regulation and Taxation of Marihuana Act, for an event where the
onsite sale or consumption of marihuana products, or both, are authorized at
the location indicated on the state license during the dates indicated on the
state license.
(2) Terms defined in the
acts have the same meanings when used in these rules unless otherwise indicated.
(1) A licensee shall enter all of the following in the statewide monitoring
system:
(a) All sales, transactions, and transfers of marihuana from the licensee to another person, including, but not limited to, a marihuana customer, another licensee, or an employee of the licensee.
(b) All marihuana in the licensee’s inventory. A licensee shall enter marihuana into the statewide monitoring system within 24 hours of accepting a transfer of marihuana into the licensee’s inventory.
(c) If the licensee is a cultivator, producer, marihuana sales location, class A marihuana microbusiness, or a laboratory transferring marihuana to another laboratory, a route plan and manifest.
(d) All marihuana waste that is created and disposed of.
(2) A cultivator shall enter all of the following in the statewide monitoring system:
(a) Identification and tracking information for each immature plant batch, mature marihuana plant, and harvest batch located at the cultivator.
(b) Identification and tracking information for each stage of cultivation, including growth, harvest, manicure, and packaging.
(c) The room or, if the cultivator cultivates marihuana outdoors, the row where an immature plant batch, mature marihuana plant, harvest batch, waste, or package is physically located. The information entered under this subdivision must correspond to the information required under R 420.205(7).
(d) A name for an immature plant batch. The name must include the date of planting.
(e) A name for a harvest batch. The name must include the date the harvest batch is created.
(f) The actual wet weight of each plant that is harvested.
(g) The amount of marihuana plant waste generated.
(3) A cultivator operating with a stacked license may enter all information required under this rule under 1 license.
(4) A producer shall enter all of the following in the statewide monitoring system:
(a) The package tag number of marihuana that undergoes processing.
(b) The amount of marihuana used during processing.
(c) The processing method used to process the marihuana.
(d) The amount of plant material remaining after processing that is free of cannabinoids and terpenes.
(e) For a new marihuana-infused product item, all of the following:
(i) Name of the item.
(ii) Brand.
(iii) Concentration of THC and cannabidiol (CBD) in the item.
(iv) If the item is an edible marihuana product, the expiration date required in R 420.402a(2).
(f) The room or area within the marihuana business location where marihuana is physically located.
(5) A marihuana transporter shall enter all of the following in the statewide monitoring system:
(a) When the marihuana transporter takes possession of marihuana and when the marihuana transporter gives up possession of marihuana.
(b) If maintaining possession of marihuana overnight, identification and tracking information related to overnight possession.
(6) A marihuana sales location shall enter into the statewide monitoring system within 1 day of becoming aware of, or within 1 day of when the licensee should have been aware of, an adverse reaction to marihuana sold or transferred by any licensee.
(7) A licensee shall track in the statewide monitoring system marihuana plants and marihuana concentrate designated for product development and the transfer of product development inventory.
(8) A licensee participating in an approved research study under R 420.407 shall track all marihuana involved in the research study in the statewide monitoring system.
(9) All numerical values entered into the statewide monitoring system must be rounded to 1 decimal place. If the number in the second decimal place is 5 or greater, the number in the first decimal place must be rounded up.
(10) A licensee shall accurately enter information in the statewide monitoring system. If a licensee enters incorrect information or needs to adjust information that was previously entered, the licensee shall do all of the following:
(a) Report the need for the correction or adjustment and document the support ticket number.
(b) Correct the error within 7 days after becoming aware or receiving notification of the error.
(c) Document and explain the correction or adjustment.
R 420.201a Statewide monitoring system; item categories; transfer categories.
Rule 201a. (1) A licensee shall categorize marihuana in the statewide monitoring system according to the following item categories:
(a) “Buds,” which includes whole dried or cured buds.
(b) “Concentrate,” which includes shatter, batter, sauce, sugar, and rick simpson oil.
(c) “Infused liquids,” which includes tinctures and drink enhancers.
(d) “Infused edible,” which includes gummies, chocolate bars, capsules, and other similar products meant to be consumed orally.
(e) “Infused non-edible liquid,” which includes topicals such as lotion and balm.
(f) “Infused non-edible solid,” which includes patches, tampons, suppositories, and other similar products that are not consumed orally.
(g) “Inhalable compound concentrate,” which includes pre-rolls with concentrate added, moon rocks, and other similar products.
(h) “Vape cart,” which includes any vaping product.
(i) “Wet whole plant,” which includes plant material that is frozen at harvest, including buds, shake, and trim, or a combination of buds, shake, and trim.
(j) “Infused beverage,” which includes beverages.
(2) If marihuana does not appropriately fit into 1 of the categories in subrule (1) of this rule, a licensee may request that the agency create a new category for the marihuana. The agency may create additional categories if it determines a marihuana does not fit into a category in subrule (1) of this rule.
(3) A licensee shall categorize a transfer of marihuana in the statewide monitoring system according to 1 of the following transfer categories.
(a) “Adult-use affiliated transfer” for transfers between adult-use licenses held by the same licensee.
(b) “Adult-use seeds and seedlings” for adult-use cultivators to accept a transfer of seeds or seedlings from individuals 21 years of age or older.
(c) “Caregiver” for medical cultivators to accept a transfer of seeds, seedlings, tissue cultures, or cuttings from a registered caregiver.
(d) “Educational research license transfer” for transfers to an educational research license.
(e) “External cannabinoids” for acquiring cannabinoids from businesses that do not hold a marihuana license. The THC concentration of external cannabinoids must be 0.3% or less.
(f) “Grow to grow between medical and adult-use” for equivalent license transfers between cultivators.
(g) “Immature plants between medical and adult-use” for transferring immature plants between equivalent medical and adult-use licenses under the same ownership.
(h) “Infusion transfer” for transferring plant material for extraction when an upfront price has not been negotiated. This includes third party processing agreements.
(i) “Medical affiliated transfer” for transfers between medical licenses held by the same licensee.
(j) “Microbusiness transfer” for transfers of seeds, tissue cultures, and clones that do not meet the definition of a plant to a microbusiness.
(k) “PC and Retailer between Med and AU” for equivalent license transfers between sales locations.
(l) “Processor to processor between medical and adult-use” for equivalent license transfers between producers.
(m) “Product development transfer” for the transfer of product development packages.
(n) “Temporary event” to create a manifest for product going to a temporary event. This transfer must be voided after the manifest is printed.
(o) “Temporary event – return” to create a manifest for product returning from a temporary event. This transfer must be voided after the manifest is printed.
(p) “Testing transfer (to laboratories)” for transfers to laboratories when the laboratory is the transporter.
(q) “Tolling transfer” for a transfer of raw goods to another marihuana business to be processed for a fee or toll.
(r) “Trade sample transfer” for trade sample transfers to another license where the shipping facility is the transporter.
(s) “Wholesale” for transfers between licenses when the product is being sold with an upfront price negotiated. The price entered is the price paid for the product and not the rate per pound.
(4) The agency may add, delete, or revise item categories and transfer categories as it determines necessary. Licensees are required to categorize items and transfers according to changes made under this subrule.
(5) If a licensee is engaged in product development, product development inventory entered into the statewide monitoring system must include the words “product development” in the item name.
R 420.201b Statewide monitoring system; sampling; testing results.
Rule 201b. (1) A laboratory shall enter the results of a test performed under part 5 of these rules into the statewide monitoring system and upload the certificate of analysis.
(2) The laboratory shall enter the test results and upload the certificate of analysis within 5 days after a test is completed.
(3) A marihuana business from which a sample is collected shall enter identifying information for the sample in the statewide monitoring system.
(4) A laboratory shall enter identifying information for a sample of marihuana collected under R 420.302, including all of the following:
(a) The complete identification number assigned by the statewide monitoring system.
(b) The name of the product.
(c) The type of product.
(d) The number of containers collected.
(e) The weight of the sample collected.
(f) The weight of the sample that was tested.
(5) Marihuana is not considered to have passed testing until the requirements of subrule (1) of this rule are met.
R 420.201c Statewide monitoring system; access.
Rule 201c. (1) A licensee shall do all of the following:
(a) Obtain login information for an account in the statewide monitoring system before acquiring or possessing marihuana.
(b) Enter into the statewide monitoring system identifying information for each employee and the level of access the employee has. The licensee shall enter this information within 10 days after hiring the employee.
(c) Update information about an employee’s employment status or level of access within 10 days after a change in employment status or level of access.
(d) Remove an employee’s access to the statewide monitoring system within 10 days after the employee’s employment at the marihuana business ends.
(e) If using an application programming interface to connect to and interface with the statewide monitoring system, assign each employee using the application programming interface a unique identifier.
(f) Assign and maintain an administrator for each license.
(2) The statewide monitoring system assigns each employee a unique identification number.
R 420.202 Adoption by
reference Marihuana businesses; operations; general.
Rule 2202. (1)
The following codes, standards, or regulations of nationally recognized
organizations or associations are adopted by reference in these rules:
National fire protection
association (NFPA) standard 1, 2021 edition, entitled “Fire
Code,” is adopted by reference
as part of these rules. Copies of the adopted provisions are available for
inspection and distribution from the National Fire Protection Association, 1
Batterymarch Park, P.O. Box 9101, Quincy, Massachusetts, 02169, telephone
number 1-800-344-3555, for the price of $114.50.
(b) National fire protection
association (NFPA) standard 58, 2020 edition, entitled “Liquified Petroleum Gas
Code,” is adopted by reference as part of these rules. Copies of the adopted
provisions are available for inspection and distribution from the National Fire
Protection Association, 1 Batterymarch Park, P.O. Box 9101, Quincy,
Massachusetts, 02169, telephone number 1-800-344-3555, for the price of $70.50.
(2) The standards adopted in
subrule (1) of this rule are available for inspection and distribution at the
agency, located at 2407 North Grand River Avenue, Lansing, Michigan, 48906.
Copies of these standards may be obtained from the agency at the cost indicated
in subrule (1)(a) and (b) of this rule, plus shipping and handling. (1)
A marihuana business shall comply with all of the following:
(a) Except as provided in R 420.102, R 420.204, and R 420.1004, a marihuana business must be completely separated from other marihuana businesses or activity, other businesses, or dwellings by immovable floor-to-ceiling walls.
(b) A marihuana business shall not allow onsite or as part of the marihuana business any of the following:
(i) Except as provided in subrule (7) of this rule, the sale, consumption, or serving of food, unless the business is a designated consumption establishment or a temporary marihuana event that has obtained required authorizations from other federal, state, or local agencies.
(ii) Consumption, use, or inhalation of marihuana unless the licensee is granted a designated consumption establishment or temporary marihuana event license.
(2) Except for sales at a temporary marihuana event, a marihuana business shall not cultivate, process, store, test, or sell marihuana at a location other than the marihuana business’ licensed location.
(3) A marihuana business shall prohibit anyone other than the licensee, employees of the licensee, escorted visitors, and the agency from accessing the limited-access areas.
(4) A marihuana business shall not sell or transfer marihuana by mail order or on consignment.
(5) A marihuana license must be framed under a transparent material and prominently displayed in the marihuana business.
(6) A cultivator, producer, marihuana microbusiness, class A marihuana microbusiness, and marihuana sales location shall perform physical audits of their inventory not less than once every 6 months and make any corrections in the statewide monitoring system as required in R 420.201.
(7) A marihuana business may have a designated area for the consumption of food and beverages that is separated by floor to ceiling walls and doors from areas where marihuana is present.
R 420.203 Marihuana licenses;
licensees; operations; general Operating marihuana businesses at the
same location.
Rule 3203. (1)
A marihuana license and a stacked license as described in these rules are
limited to the scope of the marihuana license issued for that type of marihuana
business that is located within the municipal boundaries connected with the
marihuana license.
(2) A licensee shall comply
with all of the following:
(a) Except as provided in R
420.204 and R 420.205, a marihuana business must be partitioned from any other
marihuana business or activity, any other business, or any dwelling.
(b) A marihuana business
shall not allow onsite or as part of the marihuana business any of the
following:
(i) Sale, consumption, or
serving of food except as provided in these rules unless the business is a
designated consumption establishment or a temporary marihuana event that has
obtained any required authorizations from other federal, state, or local agencies.
(ii) Consumption, use, or
inhalation of a marihuana product unless the licensee has been granted a
designated consumption establishment or temporary marihuana event license under
the MRTMA, and these rules.
(c) A marihuana business
must have distinct and identifiable areas with designated structures that are
contiguous and specific to the marihuana license.
(d) A marihuana business
must have separate entrances and exits, inventory, record keeping, and point of
sale operations, if applicable.
(e) Access to a marihuana
business’s restricted and limited access areas is restricted to the licensee,
employees of the licensee, escorted visitors, and the agency. A marihuana sales
location, a marihuana microbusiness, or a class A marihuana microbusiness may
grant access as provided in R 420.206(9) to customers to a dedicated point of
sale area.
(f) Licensee records must
be maintained as follows and made available to the agency upon request:
(i) A licensee shall
maintain accurate and comprehensive financial records for each license that
clearly documents the licensee’s income and expenses. Applicable supporting
source documentation must be maintained, including, but not limited to, all of
the following:
(A) Cash logs.
(B) Sales records.
(C) Purchase of
inventory.
(D) Invoices.
(E) Receipts.
(F) Deposit slips.
(G) Cancelled checks.
(H) Employee compensation
records.
(I) Tax records.
(ii) Bulk financial
deposits or transactions must be traceable to the individual transactions that
comprise the bulk deposit or transaction.
(iii) Licensee records
must be maintained for at least 4 years, except in instances of investigation
or inspection by the agency in which case the licensee shall retain the records
until such time as the agency notifies the licensee that the recordings may be
destroyed.
(g) The marihuana business
must be at a fixed location. Mobile marihuana businesses are prohibited. Any
sales or transfers of marihuana product by mail order or on consignment are
prohibited.
(h) A marihuana license
must be framed under a transparent material and prominently displayed in the
marihuana business.
(3) A marihuana business
shall comply with all of the following:
(a) The natural resources
and environmental protection act, 1994 PA 451, MCL 324.101 to 324.90106. The
agency may publish guidance in cooperation with the department of environment,
great lakes, and energy.
(b) Any other operational
measures requested by the agency that are not inconsistent with the acts and
these rules. (1) A licensee that holds licenses for more than 1
marihuana business may operate those marihuana businesses at a single property.
(2) Except as provided in subrules (3) and (4) of this rule, all of the following apply to operating marihuana businesses under subrule (1) of this rule:
(a) Each marihuana business must be partitioned from other marihuana businesses and have a separate street address or a separate business suite.
(b) The licensee shall obtain authorization from the agency to operate marihuana businesses at the same location before operating at the same location.
(c) Operating marihuana businesses at the same location must not violate local ordinances or regulations.
(d) The licensee shall prominently display the marihuana license for each marihuana business on the wall within the premises of each marihuana business.
(3) Marihuana businesses operating at the same location may include a combined space for the following purposes:
(a) Performing internal analytical testing under R 420.215.
(b) Storage of marihuana in final form.
(c) A designated area for consumption of food and beverages under R 420.202(7).
(d) Loading and unloading marihuana.
(e) Storage of the physical media or storage device on which surveillance recordings are stored under R 420.209(10).
(4) Marihuana businesses with equivalent licenses or stacked licenses under R 420.17 operating at the same location are not required to have any of the following:
(a) Separate business suites, partitions, or addresses.
(b) Separate entrances and exits.
(c) Separate marihuana business locations.
(d) Separate point of sale areas.
(5) A marihuana retailer under the MRTMA and a marihuana provisioning center under the MMFLA operating at the same location under subrule (4) of this rule shall do both of the following:
(a) Physically separate the entire inventories and the items on display for sale so that individuals can clearly identify marihuana sold under the MRTMA from marihuana sold under the MMFLA.
(b) Not bundle a product subject to the excise tax in section 13 of the MRTMA, MCL 333.27963, in a single transaction with a product or service that is not subject to the tax imposed by that section.
Rule 420.203a Transfer of marihuana between equivalent licenses.
Rule 203a. (1) A licensee that holds equivalent licenses may transfer marihuana that has passed all testing required under part 5 of these rules between the inventory of their equivalent licenses.
(2) Marihuana plants transferred between cultivators under this rule count toward the authorized total amount of marihuana plants for the cultivator that receives the transfer.
(3) A licensee shall not transfer marihuana to an equivalent license without first obtaining agency approval if the marihuana passed total yeast and mold testing, but the total yeast and mold level was above 10,000 colony-forming units per gram (CFU/g).
(4) A licensee shall not transfer marihuana that was obtained from a primary caregiver registered under the Michigan Medical Marihuana Act.
R 420.204 Operation at same
location Marihuana microbusiness.
Rule 4204. (1)
A licensee that has any combination of marihuana licenses may operate separate
marihuana businesses at the same location. For purposes of this rule, a stacked
license is considered a single marihuana business.
(2) To operate at the same
location subject to subrule (1) of this rule, a licensee shall meet all of the
following requirements:
(a) The agency has
authorized the proposed operation at the same location.
(b) The operation at the
same location is not in violation of any local ordinances or regulations.
(c) The operation at the
same location does not circumvent a municipal ordinance or zoning regulation
that limits the marihuana businesses under the acts.
(d) The licensee of each
marihuana business operating at the same location under this rule shall do all
the following:
(i) Apply for and be
granted separate marihuana licenses and pay the required fees for each
marihuana license.
(ii) Have distinct and
identifiable areas with designated structures that are on the same parcel or a
contiguous parcel and specific to the marihuana license.
(iii) Have separate
inventory, record keeping, and point of sale operations.
(iv) Post each marihuana
license on the wall in its distinct area and as provided in these rules.
(v) Obtain any additional
inspections and permits required for local or state building inspection, fire
services, and public health standards.
(vi) Comply with the
provisions in the acts and these rules.
(3) Operation of a marihuana
license at the same location that includes a licensed marihuana sales location
must have the entrance and exit to the licensed marihuana sales location and
entire inventory physically separated from any of the other licensed marihuana
businesses so that individuals can clearly identify the sales entrance and
exit.
(4) Operation of marihuana
licenses at the same location may include a combined space for the following purposes:
(a) Complying with R
420.214a.
(b) Storage of marijuana
and marijuana products in final form.
(c) A designated area under
420.602(5).
(d) Loading and unloading
marijuana product.
(e) Storage of the physical
media or storage device on which surveillance recordings are stored under R
420.209(10).
(5) A laboratory may be
co-located with an existing accredited laboratory that is not licensed by the
MRA, with agency approval, if the following criteria are met:
(a) The existing laboratory
performs analytical scientific testing in a laboratory environment, and the
testing methods are recognized by an accrediting body.
(b) Testing of marihuana
product is performed separately from other materials.
(c) All marihuana product
is stored separately from any other materials located at the site for testing. (1)
A marihuana microbusiness is subject to all the provisions and requirements in
these rules that apply to a marihuana grower, marihuana processor, and
marihuana retailer.
(2) A marihuana microbusiness shall comply with the corresponding requirements of a marihuana grower, marihuana processor, and marihuana retailer.
(3) In addition to the activities described in section 10(1)(f) of the MRTMA, MCL 333.27960, a marihuana microbusiness may do both of the following:
(a) Purchase or accept the transfer of marihuana seeds, tissue cultures, and clones that do not meet the definition of marihuana plant from a marihuana grower licensed under the MRTMA. A marihuana microbusiness shall not sell or transfer marihuana seeds, tissue cultures, or clones received under this subrule.
(b) Accept the transfer of marihuana plants from a registered primary caregiver if the registered primary caregiver is a supplemental applicant for the marihuana microbusiness license. A marihuana microbusiness shall only accept a transfer under this subdivision once at the time of licensure.
R 420.205 Equivalent
licenses; operation at same location Cultivators.
Rule 5205. (1)
A person that holds equivalent licenses with common ownership under the acts
may operate those equivalent licenses at the same location.
(2) To operate equivalent
licenses at the same location, all of the following requirements must be met:
(a) The agency has
authorized the proposed operation at the same location.
(b) The operation at the
same location is not in violation of any local ordinances or regulations.
(c) The operation at the
same location does not circumvent a municipal ordinance or zoning regulation
that limits the marihuana businesses under the acts.
(d) The person operating
the equivalent licenses at the same location under this rule shall do all the
following:
(i) Apply for and be
granted a separate state license and a state operating license and pay the
required fees for each license.
(ii) Post each state
license and state operating license on the wall in its distinct area and as
provided in these rules.
(iii) Obtain any
additional inspections and permits required for local or state building
inspection, fire services, and public health standards, if applicable.
(iv) Comply with the
provisions in the acts and these rules.
(3) A licensee with common
ownership of a marihuana retailer and a provisioning center and operating
equivalent licenses at the same location shall physically separate the entire
inventories and the items on display for sale so that individuals may clearly
identify medical marihuana products from adult-use marihuana products.
(4) A licensee with common
ownership of a marihuana retailer and a provisioning center and operating the
equivalent licenses at the same location shall not bundle a product subject to
the excise tax in section 13 of the MRTMA, MCL 333.27963, in a single
transaction with a product or service that is not subject to the tax imposed by
that section.
(5) A person who holds
equivalent licenses with common ownership under the acts and operates at the
same location is not required to have any of the following:
(a) Separate business
suites, partitions, or addresses.
(b) Separate entrances and
exits.
(c) Distinct and
identifiable areas with designated structures that are contiguous and specific
to the state license and the state operating license.
(d) Separate point of sale
area and operations. (1) A cultivator shall conduct its operations
within a building, except that cultivation may occur in an outdoor area, if both
of the following conditions are met:
(a) The outdoor area used for cultivating marihuana plants complies with all of the following:
(i) Is contiguous with the building.
(ii) Is fully enclosed by fences or barriers that ensure that the plants are not visible from a public place without the use of binoculars, aircraft, or other optical aids.
(iii) Fences are secured and comply with the applicable security measures in these rules, including, but not limited to, locked entries that are accessible only to authorized persons or emergency personnel.
(b) After the marihuana is harvested, all drying, trimming, curing, and packaging of marihuana must occur inside a building.
(2) A grower under the MMFLA shall not cultivate more plants than are allowed under section 501 of the MMFLA, MCL 333.27501, and a marihuana grower under the MRTMA shall not cultivate more plants than are allowed under section 9 of the MRTMA, MCL 333.27979. For purposes of this subrule, only mature marihuana plants are included in the plant count under the MRTMA.
(3) A cultivator that holds stacked licenses under R 420.17 may cultivate all of the marihuana plants allowed under subrule (2) of this rule under 1 license. All of the following apply to plants cultivated under this subrule:
(a) The total number of marihuana plants a class C marihuana grower under the MRTMA cultivates cannot exceed the total number of marihuana plants that could be cultivated if the plants were cultivated under each individual license.
(b) The total number of marihuana plants a class C grower under the MMFLA cultivates cannot exceed the total number of marihuana plants that could be cultivated if the plants were cultivated under each individual license.
(4) A cultivator shall assign an immature marihuana plant to an immature plant batch and identify the immature plant batch with a single batch name. An immature plant batch must not consist of more than 100 immature plants.
(5) A cultivator shall physically attach a plant tag to a marihuana plant once the plant reaches a height of 8 inches, measured from the top surface of the growing medium to the top leaf of the plant, or more than 8 inches in width, and ensure that the plant tag is always affixed to the plant throughout the growing cycle so that all plants can be easily identified and inspected.
(6) A cultivator shall separate marihuana plants as the plants go through different growth stages.
(7) If a cultivator is cultivating marihuana indoors, the cultivator shall identify and label each room used for cultivating. If a cultivator is cultivating marihuana outdoors, the cultivator shall identify and label each row in a plot. The cultivator shall use the identification information for the room or row to comply with the requirement in R 420.201(2)(c).
(8) In addition to the activities described in section 10(1)(a) of the MRTMA, MCL 333.27960, a marihuana grower licensed under the MRTMA may do both of the following:
(a) Purchase or accept the transfer of marihuana seeds, tissue cultures, and clones that do not meet the definition of mature plant at any time from another cultivator.
(b) If the cultivator is a class A marihuana grower, accept the transfer of marihuana plants from a registered primary caregiver if the registered primary caregiver is a supplemental applicant for the class A marihuana grower license. A class A marihuana grower shall only accept a transfer under this subdivision once at the time of licensure.
R 420.205a Harvest batch; identification and tracking; testing.
Rule 205a. (1) Once a tagged plant is harvested, it is part of a harvest batch.
(2) A cultivator shall do all of the following:
(a) Ensure that a harvest batch is easily distinguishable from other harvest batches until the batch is broken down into packages.
(b) Separate the harvest batch by product categories.
(c) Quarantine a harvest batch from all other marihuana when the harvest batch has test results pending.
(d) Destroy the individual plant tags before packaging.
(3) After a marihuana plant is harvested, the cultivator shall label each harvested part of the plant with the identification number of the plant tag in a way that clearly identifies from which marihuana plant the part was harvested.
(4) If marihuana that is tracked under 1 tag is stored in multiple containers after harvest, the cultivator shall indicate the tag number on all containers containing the marihuana and the total number of containers containing marihuana tracked under that tag.
(5) Before a cultivator transfers or sells marihuana to a marihuana sales location, a sample of the harvest batch must pass testing under part 5 of these rules.
(6) A cultivator shall quarantine a harvest batch from other marihuana if samples have been collected for testing under part 5 of these rules and the harvest batch has not yet passed full compliance testing. The quarantined marihuana may not be packaged, transferred, or sold until the marihuana passes all required testing.
(7) The maximum harvest batch is 50 pounds.
(8) A cultivator shall not do any of the following:
(a) Except as provided in R 420.401, combine harvest batches.
(b) Except as provided in R 420.401, transfer or sell marihuana to a marihuana sales location if the package contains marihuana from more than 1 harvest batch.
(c) Transfer or sell marihuana that does not have a package tag attached and is not recorded in the statewide monitoring system.
R 420.206 Marihuana business;
general requirements Marihuana transporters.
Rule 6206. (1)
A cultivator shall not operate a marihuana business unless either of the
following conditions is met:
(a) The cultivator
operations are within a building that meets the security requirements and
passes the inspections in these rules and has a building permit pursuant to R
420.208 and these rules.
(b) The cultivator
operations are within a building, except that cultivation may occur in an
outdoor area, if all of the following conditions are met:
(i) The outdoor area containing
the cultivation of marihuana plants is contiguous with the building, fully
enclosed by fences or barriers that ensure that the plants are not visible from
a public place without the use of binoculars, aircraft, or other optical aids,
and the fences are secured and comply with the applicable security measures in
these rules, including, but not limited to, locked entries only accessible to
authorized persons or emergency personnel.
(ii) After the marihuana
is harvested, all drying, trimming, curing, or packaging of marihuana occurs
inside the building meeting all the requirements under these rules.
(iii) The building meets
the security requirements and passes the inspections in these rules and has a
building permit pursuant to R 420.208 and these rules.
(2) A cultivator who has
obtained good agricultural collection processes certification may sell immature
plants to a marihuana sales location under the allowances published by the
agency.
(3) The agency shall publish
a list of approved chemical residue active ingredients for cultivators to use
in the cultivation and production of marihuana plants and marihuana products to
be sold or transferred in accordance with the acts or these rules.
(4) The agency shall publish
a list of banned chemical residue active ingredients that are prohibited from
use in the cultivation and production of marihuana plants and marihuana
products to be sold or transferred in accordance with the acts or these rules.
(5) A marihuana secure
transporter under the MRTMA shall have a primary place of business as its
marihuana business that operates in a municipality that has not adopted an
ordinance prohibiting marihuana businesses from operating within its boundaries
under section 6 of the MRTMA, MCL 333.27956, and these rules, and its marihuana
business must comply with the requirements prescribed by the MRTMA, these
rules, and any municipal ordinances that meet the requirements of section 6 of
the act, MCL 333.27956.
(6) A secure transporter
under the MMFLA shall have a primary place of business as its marihuana
facility that operates in a municipality that has adopted an ordinance that
meets the requirements of section 205 of the act, MCL 333.27205, and the rules,
and its marihuana facility must comply with the requirements prescribed by the
MMFLA and these rules.
(7) A marihuana transporter
shall hold a separate license for every marihuana transporter location. A
marihuana transporter may travel through any municipality to transport a
marihuana product. A marihuana transporter shall comply with all of the
following:
(a) The marihuana
transporter may take physical custody of the marihuana or money, but legal
custody belongs to the transferor or transferee.
(b) A marihuana transporter
shall not sell or purchase marihuana products.
(c) A marihuana transporter
shall transport any marihuana product in a locked, secured, and sealed
container that is not accessible while in transit. The container must be
secured by a locked closed lid or door, or sealed by tamper-proof tape or
equivalent provided the means of sealing the product would alert the receiving facility
that the product had been tampered with at some point from the time it departed
the shipping facility. A marihuana transporter of marihuana product from
separate marihuana businesses shall not comingle the marihuana product. All
marihuana products must be labeled in accordance with these rules and kept in
separate compartments or containers within the main locked, secured, and sealed
container. If the marihuana transporter transports money associated with the
purchase or sale of marihuana product between businesses, the marihuana
transporter shall lock the money in a sealed container kept separate from the
marihuana product and only accessible to the licensee and its employees.
(d) A marihuana transporter
shall log and track all handling of money associated with the purchase or sale
of marihuana between marihuana businesses. These records must be maintained and
made available to the agency upon request.
(e) A marihuana transporter
shall have a route plan and manifest available for inspection by the agency to
determine compliance with the acts and these rules. A copy of the route plan
and manifest must be carried with the marihuana transporter during transport
between marihuana businesses. A marihuana transporter is subject to
administrative inspection by a law enforcement officer at any point during the
transportation of marihuana product pursuant to these rules. A marihuana
transporter shall carry a copy of a route plan and manifest in the transporting
vehicle and shall present them to a law enforcement officer upon request.
(f) A marihuana transporter
shall not possess marihuana product that is not on a manifest.
(g) A marihuana transporter
shall follow the manifest.
(h) A marihuana transporter
shall store vehicles at its primary place of business. If a marihuana
transporter stores a vehicle that does not contain marihuana or marihuana
product at a location that is not its primary place of business, it shall indicate
that in its business plan.
(i) A marihuana transporter
transferring marihuana product to a marihuana business shall remain onsite
until the marihuana product is weighed and accepted or rejected before leaving
the marihuana business.
(j) A marihuana transporter
shall not maintain custody of the marihuana product for more than 96 hours
unless permission is otherwise sought and granted by the agency, which will be
reviewed on a case-by case basis.
(k) A marihuana transporter
shall identify and record all vehicles with the agency and have the required
vehicle registration with the secretary of state as required under state law.
A marihuana transporter’s vehicles are subject to inspection at any time by the
agency to determine compliance with the acts or these rules.
(8) A laboratory shall
comply with all of the following:
(a) Provide written notice
to the agency within 7 days of a laboratory manager no longer being employed at
the facility.
(b) Designate an interim
laboratory manager within 7 days of the laboratory manager’s departure. The
interim laboratory manager must meet either of the following requirements:
(i) The interim laboratory
manager must meet at least 1 of the qualifications for a laboratory manager.
(ii) The interim
laboratory manager must have, at minimum, a bachelor’s degree in 1 of the
natural sciences and 3 years of full-time laboratory experience in a regulated
laboratory environment, performing analytical scientific testing in which the
testing methods were recognized by an accrediting body. A combination of
education and experience may substitute for the 3 years of full-time laboratory
experience.
(c) Hire a permanent
laboratory manager within 60 calendar days from the date of the previous
laboratory manager’s departure, unless the laboratory receives a written waiver
from the agency. A laboratory may submit a waiver request to the agency to
receive an additional 60 calendar days to hire a permanent laboratory manager
if the laboratory submits a detailed oversight plan along with the waiver
request.
(9) A marihuana sales
location must have a separate room that is dedicated as the point of sale area
for the transfer or sale of marihuana product as provided in the acts and these
rules. The marihuana sales location shall keep marihuana products behind a
counter or other barrier to ensure that a customer does not have direct access
to the marihuana products. A marihuana sales location may also have a
designated area for contactless or limited contact transactions.
(10) A marihuana business
shall label all marihuana products with the ingredients of the product, in
descending order of predominance by weight.
(11) All non-marihuana
inactive ingredients must be clearly listed on the product label. Inactive ingredients,
other than botanically derived flavonoids, terpenoids, and terpenes that are
chemically identical to the terpenes derived from the plant Cannabis sativa L.,
must be approved by the FDA for the intended use, and the concentration must be
less than the maximum concentration listed in the FDA Inactive Ingredient
database for the intended use.
(12) A marihuana business
producing marihuana products shall maintain records of formulation and make
them available to the agency upon request.
(13) All ingredients
containing cannabinoids, whether naturally occurring or synthetically derived,
that are added to marihuana or marihuana products must be from a source
licensed to grow, handle, and produce cannabinoids under a license issued by a
governmental authority and entered into the statewide monitoring system.
(14) When combining
marihuana and marihuana product into another marihuana product, each form of
marihuana and marihuana product being combined must have passing safety
compliance test results in the statewide monitoring system prior to the
creation of the new combined product.
(15) A marihuana business
shall comply with random compliance checks upon the request of the agency. The
agency or its authorized agents may collect a random sample of a marihuana
product from a marihuana business or designate a laboratory to collect a random
sample of a marihuana product in a secure manner to test that sample for
compliance.
(16) The agency may update
or issue new standards as necessary to protect the health, safety, and welfare
of consumers and the public. A marihuana business shall comply with all new or
updated standards issued by the agency within 6 months of their adoption by the
agency unless there is an identifiable public health or safety risk.
(17) A marihuana business
transferring marihuana product to or receiving marihuana product from a
marihuana transporter shall initiate the procedures to transfer or receive the
marihuana product within 30 minutes of the marihuana transporter’s arrival at
the marihuana business. (1) In addition to the activities described in section
10(1)(c) of the MRMTA, MCL 333.27960, a marihuana secure transporter under the
MRTMA may also store and transport money associated with the purchase or sale
of marihuana.
(2) A marihuana transporter shall do all of the following:
(a) Transport marihuana and money associated with the purchase or sale of marihuana in a motor vehicle as that term is defined in section 33 of the Michigan vehicle code, 1949 PA 300, MCL 257.33.
(b) Register all vehicles used to transport marihuana with the secretary of state as required under the Michigan Vehicle Code, MCL 257.1 to 257.923.
(c) Identify and record all vehicles used to transport marihuana with the agency.
(d) Ensure that each driver transporting marihuana has a chauffeur's license issued by the secretary of state.
(e) Operate each vehicle transporting marihuana with a 2-individual crew, with at least 1 individual remaining with the vehicle at all times during the transportation of marihuana.
(f) Store vehicles at its primary place of business. If a marihuana transporter stores a vehicle that does not contain marihuana at a location that is not its primary place of business, it shall indicate that in its business plan.
(g) Transport marihuana in a secured container that is not accessible while in transit. The container must be secured by a locked closed lid or door, or sealed by a tamper-proof tape that indicates if the marihuana had been tampered with during transport.
(h) Transport money associated with the purchase or sale of marihuana between businesses in a locked, secured, and sealed container maintained separate from marihuana and only accessible to the licensee and its employees.
(3) Before transporting marihuana, a marihuana transporter shall create a route plan and manifest. All of the following apply to the route plan and manifest:
(a) A marihuana transporter shall follow the route plan when transporting marihuana and only possess or transport marihuana that is included on the manifest.
(b) A marihuana transporter shall carry a copy of the route plan and manifest during transport between marihuana businesses and make the route plan and manifest available to the agency or law enforcement on request.
(4) A marihuana transporter may take physical custody of marihuana or money, but legal custody of the marihuana or money belongs to the person transferring or receiving the marihuana or money.
(5) A marihuana transporter shall not do any of the following:
(a) Transport marihuana to a registered qualifying patient or registered primary caregiver.
(b) Transport marihuana in a vehicle that bears markings or other indication that it is carrying marihuana.
(c) If transporting marihuana from separate marihuana businesses, comingle the marihuana.
(d) Maintain custody of the marihuana for more than 168 hours unless permission to maintain custody of marihuana for more than 168 hours is sought and granted by the agency. Requests under this subdivision will be reviewed on a case-by case basis.
(6) A marihuana transporter transferring marihuana to a marihuana business shall remain on site until the marihuana is weighed and accepted or rejected before leaving the marihuana business.
(7) A marihuana transporter may transfer marihuana to another marihuana transporter for the purpose of completing a transfer between marihuana establishments if all of the following requirements are met:
(a) The transfer of marihuana takes place at the licensed location of a marihuana transporter.
(b) The transfer of marihuana between marihuana secure transporters is on the manifest.
(c) The transfer of marihuana between marihuana secure transporters occurs as a result of a request by the marihuana establishment that has sent the product to another marihuana establishment.
R 420.206a Standard operating
procedures. Rescinded.
Rule 6a. (1) A marihuana
business must have up-to-date written standard operating procedures on site at
all times.
(2) Standard operating
procedures must be made available to the agency upon request.
(3) Standard operating
procedures must detail the marihuana business operations and activities
necessary for the marihuana business to comply with the acts and these rules.
(4) If the agency determines
that any standard operating procedure contains inaccurate information or does
not comply with these rules and safe food management guidelines, as applicable,
the licensee may be required to correct the practice immediately and update the
standard operating procedures within 1 business day.
R 420.207 Marihuana delivery;
limited circumstances Laboratories.
Rule 7207. (1)
A marihuana sales location licensee may engage in the delivery of a marihuana
product for sale or transfer to marihuana customers upon approval by the agency
of the licensee’s delivery procedures.
(2) A marihuana sales
location licensed under the MMFLA that engages in delivery shall establish
procedures as specified in this rule to allow an employee of the marihuana
sales location to deliver a marihuana product to a patient at the patient’s
residential address.
(3) A marihuana sales location
licensed under the MRTMA that engages in delivery shall establish procedures as
specified in this rule to allow an employee of the marihuana sales location to
deliver a marihuana product to an individual 21 years of age or older at a
residential address or at the address of a designated consumption establishment
provided at the time the order was placed.
(4) All of the following
apply to the marihuana delivery procedures established by a marihuana sales
location:
(a) For the purposes of
this rule only, a marihuana sales location may accept an online order request
of a marihuana product and payment for the order that will be delivered only to
the physical residence of the registered qualifying patient as provided in this
rule, or to a residential address or the address of a designated consumption
establishment provided by an individual 21 years of age or older as provided in
this rule.
(b) The marihuana sales
location shall create a marihuana delivery procedure that is subject to
inspection and examination including, but not limited to, record keeping and
tracking requirements. The agency may publish guidelines on the required
procedure.
(c) All marihuana delivery
employees shall meet the requirements in R 420.602 and are employees, as defined
in R 420.601(1)(d), of the marihuana sales location.
(5) A marihuana sales
location that has received authorization under subrule (1) of this rule shall
comply with all of the following:
(a) The marihuana sales
location shall verify that the sale or transfer to marihuana customers is in
accordance with these rules.
(b) The marihuana delivery
employee may take payment upon delivery and shall deliver the marihuana
product.
(c) The amount of marihuana
product that may be delivered is limited to the daily and monthly purchase
limits of the registered qualifying patient as provided in these rules; or to
the single transaction purchase limits for individuals 21 years of age or older
as provided in these rules.
(d) The marihuana sales
location shall record all transactions in the statewide monitoring system as
required in the acts and these rules.
(e) An employee of the
marihuana sales location shall make marihuana deliveries only to 1 of the
following:
(i) Subject to paragraph
(ii) of this subdivision, a registered qualifying patient.
(ii) A registered primary
caregiver if the registered qualifying patient is a minor. If the registered
qualifying patient is a minor, delivery must be made only to his or her
registered primary caregiver.
(iii) An individual 21
years of age or older.
(f) A marihuana delivery
employee shall verify that the person taking delivery is the registered
qualifying patient or the registered primary caregiver of a registered
qualifying patient who is a minor, who has been recorded in the statewide
monitoring system, or the individual 21 years of age or older who placed the
order.
(g) The authorization
granted to a marihuana sales location pursuant to subrule (1) of this rule may
be denied, suspended, or withdrawn by the agency. The marihuana sales location
may be subject to other sanctions and fines as provided in the acts and these
rules.
(6) A marihuana sales
location shall maintain records of all of the following that must be made
available to the agency upon request:
(a) For a marihuana sales
location licensed under the MMFLA, confirmation that the marihuana customer
presented his or her valid driver’s license or government issued identification
bearing a photographic image of the marihuana customer along with his or her
marihuana registry card, or temporary marihuana registry card, to verify that
he or she is the patient or, if the registered qualifying patient is a minor,
the registered primary caregiver.
(b) For a marihuana sales
location licensed under the MRTMA, confirmation that the marihuana customer
presented his or her valid driver’s license or government issued identification
bearing a photographic image of the marihuana customer to verify that the
marihuana customer is 21 years of age or older at the time of delivery.
(c) Validation that the
address for marihuana delivery of a marihuana product is the residential
address of the registered qualifying patient, or the residential address or
address of a designated consumption establishment provided by the customer at
the time the order for the marihuana product was placed.
(d) Maintenance of the
following records for any motor vehicle used for marihuana delivery and the
making of the records available to the agency upon request:
(i) Vehicle make.
(ii) Vehicle model.
(iii) Vehicle color.
(iv) Vehicle
identification number.
(v) License plate number.
(vi) Vehicle registration.
(vii) Proof of vehicle
insurance.
(e) Documentation that the
marihuana customer has consented to the marihuana delivery of the marihuana
product. The consent must include an acknowledgement by the marihuana customer
for the release of information necessary in fulfilling the home delivery.
(f) Verification, by a
licensee under the MMFLA, in the statewide monitoring system that the
registered qualifying patient holds a valid, current, unexpired, and unrevoked
registry identification card as required in these rules.
(7) A marihuana delivery
employee shall carry a physical or electronic copy of all of the following
information and shall make these records available to the agency upon request:
(a) The employee
identification number required under these rules.
(b) The marihuana sales
location licensee license number.
(c) The address of the
marihuana sales location licensee.
(d) Contact information of
the marihuana sales location licensee.
(e) A copy of the marihuana
sales location marihuana delivery log as required in subrule (13) of this rule.
(8) A marihuana delivery
employee shall have access to a secure form of communication with the marihuana
sales location licensee, such as a cellular telephone, at all times in the
vehicle or on his or her person.
(9) A marihuana delivery
employee shall comply with all the following:
(a) During marihuana
delivery, the marihuana delivery employee shall maintain a physical or
electronic copy of each marihuana delivery request and shall make the marihuana
delivery request available to the agency upon request.
(b) A marihuana delivery
employee shall not leave a marihuana product in an unattended motor vehicle
unless the motor vehicle is locked and equipped with an active vehicle alarm
system.
(c) A marihuana delivery
employee’s vehicle must contain a global positioning system (GPS) device for
identifying the geographic location of the delivery vehicle. The device must
be either permanently or temporarily affixed to the delivery vehicle while the
delivery vehicle is in operation, and the device must remain active and in the
possession of the delivery employee at all times during delivery. At all times,
the marihuana sales location must be able to identify the geographic location
of all marihuana delivery vehicles and marihuana delivery employees who are
making marihuana deliveries for the marihuana sales location and shall provide
that information to the agency upon request.
(d) A marihuana delivery
employee shall not carry marihuana product in the delivery vehicle with a value
in excess of $5,000.00 at any time. The value of marihuana products carried in
the delivery vehicle for which a delivery order was not received and processed
by the licensed retailer prior to the delivery employee departing from the
marihuana sales location may not exceed $3,000.00. For the purposes of this
subrule, the value of marihuana products must be determined using the current
retail price of all marihuana products carried by, or within the delivery
vehicle of, the marihuana delivery employee.
(e) A marihuana delivery
employee of a marihuana sales location may not be employed as a marihuana
delivery employee for more than 1 marihuana sales location.
(f) A marihuana delivery
employee shall not leave the marihuana sales location with marihuana products
without at least 1 delivery order that has already been received and processed
by the marihuana sales location.
(g) Before leaving the
marihuana sales location, the marihuana delivery employee must have a delivery
inventory ledger, which may be maintained electronically, of all marihuana
products provided to him or her. For each marihuana product, the delivery
inventory ledger must include the following:
(i) The type of marihuana
product.
(ii) The brand name.
(iii) The retail value.
(iv) The tag number
associated with the product in the statewide monitoring system.
(v) The weight, volume, or
other accurate measure of the marihuana product.
(h) All marihuana product
prepared for an order that was received and processed by the marihuana sales
location prior to the marihuana delivery driver departing from the marihuana
sales location must be clearly identified on the inventory ledger.
(i) After each delivery,
the delivery inventory ledger must be updated to reflect the current inventory
in possession of the marihuana delivery employee.
(j) The marihuana delivery
employee shall maintain a log that includes all stops from the time he or she
leaves the marihuana sales location to the time that he or she returns to the
marihuana sales location, and the reason for each stop. The log must be turned
in to the marihuana sales location when the marihuana delivery employee returns
to the marihuana sales location. The marihuana sales location must maintain the
log for a minimum of 1 year from the date of delivery and make it available
upon request by the agency. The log may be maintained electronically.
(k) Immediately upon
request by the agency the marihuana delivery employee shall provide all of the
following:
(i) All delivery inventory
ledgers from the time the marihuana delivery employee left the marihuana sales
location up to the time of the request.
(ii) All delivery request
receipts for marihuana product carried by the driver, in the delivery vehicle,
or any deliveries that have already been made to customers.
(iii) The log of all stops
from the time the marihuana delivery employee left the marihuana sales location
up to the time of the request.
(l) If a marihuana delivery
employee does not have any delivery request to be performed for a 30-minute
period, the marihuana delivery employee shall not make any additional
deliveries and shall return to the marihuana sales location. Upon returning to
the marihuana sales location, all undelivered marihuana products must be
returned to inventory and all necessary inventory and statewide monitoring
system records must be updated as appropriate.
(10) A marihuana retailer
licensed under the MRTMA, in making deliveries, shall not transport more than
15 ounces of marihuana or more than 60 grams of marihuana concentrate at 1 time
pursuant to section 11 of the MRTMA, MCL 333.27961.
(11) A marihuana sales
location shall ensure that marihuana deliveries are completed in a timely and
efficient manner as provided on the marihuana delivery request and log. All
marihuana deliveries must occur within the business hours of the marihuana
sales location. Marihuana product for marihuana delivery must be stored within
a secured compartment that is clearly marked and latched or locked in a manner
to keep all contents secured within.
(12) The process of
marihuana delivery begins when the marihuana delivery employee leaves the
marihuana sales location’s licensed marihuana business with the marihuana
product for delivery. The process of marihuana delivery ends when the delivery
employee returns to the marihuana sales location’s licensed marihuana business
after delivering the marihuana product to the marihuana customer.
(13) A marihuana sales
location shall maintain a record of each delivery of a marihuana product in a
marihuana delivery log, which may be a hard copy or electronic format, and make
the marihuana delivery log
available to the agency upon request. For each delivery, the marihuana
delivery log must record all of the following:
(a) The date and time that
the delivery began and ended.
(b) The name of the
marihuana delivery employee.
(c) The amount of marihuana
product allowed to be possessed for delivery.
(d) The tag number of the
marihuana product and the name of the strain of that marihuana product.
(e) The signature of the
individual who accepted delivery.
(14) A marihuana sales
location shall notify the agency, state police, or local law enforcement of any
theft, loss of marihuana product, or criminal activity as provided in these
rules. A marihuana sales location shall report to the agency and law
enforcement, if applicable, any other event occurring during marihuana delivery
that violates the marihuana delivery procedure as provided in this rule,
including marihuana delivery vehicle accidents and diversion of marihuana
product. (1) A laboratory shall perform sampling and testing in
compliance with the requirements under part 5 of these rules.
(2) A laboratory shall be accredited by an entity approved by the agency not later than 1 year after the date the laboratory license is issued or have previously provided drug testing services to this state, or this state's court system, and be a vendor in good standing in regard to those services. The agency may grant a variance from this requirement on a finding that the variance is necessary to protect and preserve the public health, safety, or welfare.
(3) A laboratory shall be accredited for all required safety tests in at least 1 matrix to the International Organization for Standardization (ISO), ISO/IEC 17025:2017, by an International Laboratory Accreditation Cooperation (ILAC) recognized accreditation body, or by an entity approved by the agency within 1 year after the date the laboratory license is issued. The laboratory shall request the accreditation body to send the inspections, reports, and all scope documents to the agency. The laboratory shall comply with the requirements of ISO/IEC 17025:2017 at all times.
(4) A laboratory that has not achieved accreditation as required under subrule (3) of this rule shall not perform safety compliance testing or research and development testing for a licensed marihuana establishment and shall not charge or collect a fee for testing performed until compliance with subrule (3) of this rule is demonstrated to the agency.
(5) A laboratory shall employ at least 1 laboratory manager with a relevant advanced degree in a medical or laboratory science who is responsible for all of the following duties:
(a) Ensuring tests are conducted in accordance with part 5 of these rules.
(b) Ensuring test results are accurate and valid.
(c) Overseeing day-to-day operations.
(d) Validating information entered into the statewide monitoring system by the laboratory.
(6) If a laboratory’s only laboratory manager is no longer employed at the laboratory, the laboratory shall do all of the following:
(a) Provide written notice to the agency within 7 days after the laboratory manager is no longer employed at the laboratory.
(b) Designate an interim laboratory manager within 7 days after the laboratory manager’s departure. If the interim laboratory manager does not meet the qualifications in subrule (5) of this rule, the interim laboratory manager shall have, at minimum, a bachelor’s degree in 1 of the natural sciences and 3 years of full-time laboratory experience in a regulated laboratory environment, performing analytical scientific testing using testing methods that were recognized by an accrediting body. A combination of education and experience may substitute for the 3 years of full-time laboratory experience.
(c) Hire a permanent laboratory manager within 60 days after the date of the previous laboratory manager’s departure. A laboratory may submit a waiver request and detailed oversight plan to the agency to receive an additional 60 days to hire a permanent laboratory manager. If the waiver request is approved, the laboratory has another 60 days to hire a permanent laboratory manager.
(7) A laboratory shall have a secured laboratory space that cannot be accessed by the general public.
(8) A laboratory may be co-located with an existing accredited laboratory that is not licensed by the agency if all of the following criteria are met:
(a) The existing laboratory performs analytical scientific testing in a laboratory environment, and the testing methods are recognized by an accrediting body.
(b) Testing of marihuana is performed separately from other materials.
(c) All marihuana is stored separately from other materials located at the site for testing.
(d) The agency approves the co-location.
(9) In addition to the activities described in section 10(1)(d) of the MRTMA, MCL 333.27960, a marihuana safety compliance facility licensed under the MRTMA may do both of the following:
(a) Receive and test industrial hemp.
(b) Receive marihuana from an individual 21 years of age or older and test the marihuana. The marihuana safety compliance facility shall verify the individual’s age and retain documentation of the verification.
R
420.207a Contactless and limited contact transactions Rescinded.
Rule 7a. (1) A marihuana
sales location may designate an area for contactless or limited contact
transactions unless prohibited by an ordinance adopted by the municipality
where the marihuana sales location is located.
(2) Contactless or limited
contact transaction include, but are not limited to the following:
(a) Curbside service.
(b) Drive through window
service.
(3) A marihuana sales
location may accept online or telephonic orders for marihuana product and
payment for the order that will be picked up at the marihuana sales location.
(4) The designated area for
contactless or limited contact transactions must be identified in the marihuana
business location plan.
(5) A marihuana sales
location operating a contactless or limited contact transaction must have a
written standard operating procedure in place and be made available to the
agency upon request.
(6) Contactless or limited
contact transactions must be completed during normal business hours.
(7) A marihuana sales
location using a designated area for contactless or limited contact
transactions must have in place an anti-theft policy, procedure, or automatic
capability.
(8) The designated area for
contactless or limited contact transactions must comply with R 420.209.
(9) The contactless and
limited contact transaction must comply with R 420.505 and R 420.506.
(10) Marihuana being
transferred during a contactless or limited contact transaction must be in an
opaque bag and the contents must not be visible to the general public upon pick
up.
R 420.208 Building and fire
safety Producers.
Rule 8208. (1)
An applicant’s proposed marihuana business and a licensee’s marihuana business
are subject to inspection by a state building code official, state fire
official, or code enforcement official to confirm that no health or safety
concerns are present.
(2) A state building code
official, or his or her authorized designee, may conduct prelicensure and
post-licensure inspections to ensure that applicants and licensees comply with
the Stille-DeRossett-Hale single state construction code act, 1972 PA 230, MCL
125.1501 to 125.1531; the skilled trades regulation act, 2016 PA 407, MCL
339.5101 to 339.6133; 1967 PA 227, MCL 408.801 to 408.824; and 1976 PA 333, MCL
338.2151 to 338.2160.
(3) An applicant or licensee
shall not operate a marihuana business unless a permanent certificate of
occupancy has been issued by the appropriate enforcing agency. A temporary
certificate of occupancy may be accepted, at the discretion of the agency.
Before a certificate of occupancy is issued, work must be completed in
accordance with the Stille-DeRossett-Hale single state construction code act,
1972 PA 230, MCL 125.1501 to 125.1531. An applicant or licensee shall comply
with both of the following:
(a) An applicant or
licensee shall obtain a building permit for any building utilized as a proposed
marihuana business or marihuana business as provided in the acts and these
rules. The issuance, enforcement, and inspection of building permits under the
acts remains with the governmental entity having jurisdiction under the
Stille-DeRossett-Hale single state construction code act, 1972 PA 230, MCL
125.1501 to 125.1531.
(b) An applicant or
licensee shall obtain a building permit for a change of occupancy for an
existing building to be utilized as a proposed marihuana business or marihuana
business as provided in the acts and these rules.
(4) An applicant or licensee
shall not operate a marihuana business unless the proposed marihuana business
or marihuana business has passed the prelicensure fire safety inspection by the
BFS. The state fire marshal, or his or her authorized designee, may conduct
prelicensure and post-licensure inspections of a marihuana business. An
applicant or licensee shall comply with all of the following:
(a) A BFS inspection may be
conducted at any reasonable time to ensure fire safety compliance. A BFS
inspection may be annual or biannual and may result in the required
installation of fire suppression devices or other means necessary for adequate
fire safety pursuant to state standards.
(b) The BFS may require a
marihuana business to obtain operational permits, including, but not limited
to, any of the following:
(i) Carbon dioxide systems
used in beverage dispensing applications, amended for cultivation use and
extraction.
(ii) Compressed gases.
(iii) Combustible fibers.
(iv) Flammable and
combustible liquids.
(v) Fumigation and
insecticidal fogging.
(vi) Hazardous materials.
(vii) High piled storage
(high rack system cultivation).
(viii) Liquefied petroleum
(LP) gas.
(c) For specific
installation or systems, BFS may require marihuana businesses to obtain
construction permits, including, but not limited to, any of the following:
(i) Building
construction.
(ii) Electrical,
mechanical, plumbing, boiler, and elevator.
(iii) Compressed gases.
(iv) Flammable and
combustible liquids.
(v) Hazardous materials.
(vi) Liquified petroleum
(LP) gas.
(vii) Automatic fire
extinguishing/suppression systems.
(viii) Fire alarm and
detections systems.
(ix) Related equipment
found during fire safety inspections.
(5) The state fire marshal,
or their authorized designee, may conduct a BFS fire safety inspection of a
marihuana business, at any reasonable time to ensure compliance with the NFPA
1, 2021 edition, entitled “Fire Code,” which is adopted by reference in R
420.202. A licensee shall comply with the NFPA 1 as adopted and the following
additional requirements:
(a) Ductwork must be
installed in accordance with the Michigan mechanical code, R 408.30901 to R
408.30998.
(b) Suppression systems
outlined in NFPA 1 and the Michigan mechanical code, R 408.30901 to R
408.30998, must be installed if required to meet the suppression needs within a
marihuana establishment.
(c) Producers, cultivators,
laboratories, marihuana microbusinesses, and class A marihuana microbusinesses
shall implement appropriate exhaust ventilation systems to mitigate noxious
gasses or other fumes used or created as part of any production process or operations.
Exhaust and ventilation equipment must be appropriate for the hazard involved
and must comply with NFPA 1 and Michigan mechanical code, R 408.30901 to R
408.30998.
(6) In addition to meeting
all the requirements in subrules (1) to (5) of this rule, cultivators,
producers, marihuana microbusinesses, class A marihuana microbusinesses, and
designated consumption establishments shall also comply with all of the
following:
(a) Permit the agency or
its authorized agents, or state fire marshal or his or her authorized designee,
to enter and inspect a cultivator, producer, marihuana microbusiness, class A
marihuana microbusiness, and designated consumption establishments at any
reasonable time.
(b) Have a fire safety
inspection conducted, in addition to any inspections required under the acts
and these rules, if any of the following occur:
(i) Modifications to the
grow areas, rooms and storage, extraction equipment and process rooms, or
marihuana-infused product processing equipment within a marihuana business.
(ii) Changes in occupancy.
(iii) Material changes to
a new or existing cultivator, producer, marihuana microbusiness, class A
marihuana microbusiness, or designated consumption establishment including
changes made prelicensure and post-licensure.
(iv) Changes in extraction
methods and processing or grow areas and building structures.
(c) Ensure that extractions
using compressed gases of varying materials including, but not limited to,
butane, propane, and carbon dioxide that are used in multiple processes in
cultivation or extraction meet all of the following:
(i) Flammable gases of
varying materials may be used in multiple processes in cultivation or
extraction and must meet the requirements in NFPA 58 and the international fuel
gas code.
(ii) Processes that
extract oil from marihuana plants and marihuana products using flammable gas or
flammable liquid must have leak or gas detection measures, or both. All
extraction equipment used in the marihuana business and equipment used in the
detection of flammable or toxic gases, or both, must be approved by the BFS and
may require construction permits.
(iii) Marihuana businesses
that have exhaust systems must comply with the NFPA 1 and the Michigan mechanical
code, R 408.30901 to R 408.30998.
(7) The requirements of this
rule do not apply to a marihuana event organizer applicant or licensee under
the MRTMA.
(8) An applicant for a
temporary marihuana event is subject to review and inspection, if applicable,
by BFS, which includes, but is not limited to, all of the following:
(a) A site plan must be
provided. BFS shall review the site plan in accordance with the NFPA 1.
(b) The temporary marihuana
event location may be subject to a physical inspection, as determined by the
agency. (1) A producer shall give marihuana a new package tag if 1 or
more of the following occurs:
(a) The marihuana changes form, including into an intermediary product.
(b) The marihuana is incorporated into a different product.
(c) An ingredient is added to the marihuana.
(2) Except for a marihuana pre-roll that meets the requirements of R 420.401, a producer of marihuana in its final form shall have a sample tested as required in part 5 of these rules.
(3) A producer shall quarantine a production batch of marihuana from other marihuana if samples have been collected for testing under part 5 of these rules and the production batch has not yet passed full compliance testing. The quarantined marihuana may not be packaged, transferred, or sold until the marihuana passes all required testing.
(4) A producer of an edible marihuana product shall do all the following:
(a) Store potentially hazardous ingredients used to process shelf-stable edible marihuana products at or below 40 degrees Fahrenheit.
(b) Maintain and adhere to records of formulation that include, at minimum, the recipe for the edible marihuana product, additional processing documentation that demonstrates the product is shelf stable, and test results for all ingredients used to create the edible marihuana product.
(c) Do 1 or both of the following:
(i) Provide annual employee training on safe food handling for all employees involved in producing or handling edible marihuana products. A course taken pursuant to this paragraph must be not less than 2 hours in length and cover all of the following subjects:
(A) Causes of foodborne illness, highly susceptible populations, and worker illness.
(B) Personal hygiene and food handling practices.
(C) Approved sources of food.
(D) Potentially hazardous foods and food temperatures.
(E) Sanitization and chemical use.
(F) Emergency procedures, including, but not limited to, fire, flood, and sewer backup.
(G) Food allergens.
(ii) Ensure that all
employees involved in producing or handling edible marihuana products are
certified under a program described in section 2129 of the food law, 2000 PA
92, MCL 289.2129.
(d) Have an employee on site during the producer’s hours of operation who is certified as a food protection manager by the American National Standards Institute (ANSI) National Accreditation Board.
(e) Maintain proof that each employee successfully completed the training or obtained certification required under subdivisions (c) and (d) of this subrule.
(5) A producer shall maintain certificates of analysis for all non-marihuana ingredients used in the manufacturing of a marihuana-infused product.
(6) A producer shall package and properly label marihuana-infused products before sale or transfer as required in part 6 of these rules.
(7) A producer shall create and maintain records of formulation for all marihuana-infused products processed by the producer. Records of formulation must include, at a minimum, all of the following:
(a) The recipe for the marihuana-infused product.
(b) The amount of marihuana used in creating the marihuana product.
(c) The amount of marihuana-infused product created.
(d) Standard operating procedures detailing the process used to manufacture the marihuana-infused product.
(8) A producer shall adhere to the records of formulation when manufacturing a marihuana-infused product.
R 420.209 Security measures; required plan; video surveillance system.
Rule 9209. (1) An
applicant for a marihuana license to operate a proposed marihuana business
shall submit a security plan that demonstrates, at a minimum, the ability to
meetA licensee shall create, maintain, and implement a security plan
that meets the requirements of this rule.
(2) A licensee shall ensure
that an individual any person at the marihuana business, except
for an employeesemployee of the licensee, areis
escorted at all times by the licensee or an employee of the licensee when the
individual is in thea limited-access areasarea
and restricted access areas at the marihuana business.
(a) Break rooms.
(b) Offices, conference rooms, storage rooms, and closets.
(c) Bathrooms and locker rooms.
(4) A licensee shall maintain
an active alarm system at the marihuana business. Upon request, a
licensee shall make available to the agency all information related to the
alarm system, monitoring, and alarm activity.
(5) A licensee shall have a
video surveillance system that, at a minimum, consists of digital or network
video recorders, cameras capable of meeting the recording requirements in this
rule, video monitors, digital archiving devices, and a color printer capable of
deliveringprinting still photos.
(6) A licensee shall ensure the video surveillance system does all the following:
(a) Records, at a minimum, unobstructed
views of all of the following areas:
(i) Any areasAreas
where marihuana products are weighed, packed, stored, loaded, and unloaded
for transportation, prepared, or moved within the marihuana business may
be present.
(ii) Limited access areas
and security rooms. Transfers between rooms must be recorded. An area
containing a surveillance system storage device. At least 1 camera must record
the access points to the area where the surveillance system storage device is
located.
(iii) Areas storing a
surveillance system storage device with not less than 1 camera recording the
access points to the secured surveillance recording areaEntrances to and
exits from the marihuana business, including those between marihuana businesses
operating at the same location, from both indoor and outdoor vantage points.
(iv) The entrances and
exits to the building, which must be recorded from both indoor and outdoor
vantage pointsEntrances and exits to each room at a marihuana business
where marihuana may be present.
(v) The areas of entrance
and exit between marihuana businesses at the same location if applicable,
including any transfers between marihuana businessesAreas outside of the
marihuana business location that are within 20 feet of an entry and exit.
(vi) Point of sale areas
where marihuana products are sold and displayed for sale.
(vii) Areas where
marihuana or marihuana products are destroyed.
(b) Records images
effectively and efficientlyvideo of the area under surveillance with
a minimum of 720p resolution.
(c) Records when motion is detected at the marihuana business.
(d) Records video that clearly displays the time and date the video was recorded.
(7) A licensee shall ensure
that each camera is permanently mounted and in a fixed location. Each
camera must be placed in a location that allows the camera to clearly record
activity occurring within 20 feet of all points of entry and exit on the
marihuana business and allows for the clear and certain identification of any
person, including facial features, and activities, including sales or
transfers, in all areas required to be recorded under these rules.
(8) A licensee shall have sufficient lighting to meet the video surveillance system requirements of this rule.
(109) A licensee
shall secure the physical media or storage device on
which surveillance recordings are stored in a manner to protectthat
protects the recording from tampering or theft.
(1110) A licensee
shall keepmaintain surveillance recordings for a minimum of 30 calendar
days, except in instances of investigation or
inspection by the agencyunless the licensee is notified by the agency
that the licensee shall retain surveillance recordings for longer than 30 days,
in which case the licensee shall retain the recordings until the time as
the agency notifies the licensee that the recordings may be destroyed.
(12) Surveillance recordings
of the licensee are subject to inspection by the agency and must be kept in a
manner that allows the agency to view and obtain copies of the recordings at
the marihuana business immediately upon request. The licensee shall also send
or otherwise provide copies of the recordings to the agency upon request within
the time specified by the agency.
(11) A licensee shall do both of the following:
(a) Provide the agency with the capability to log into the video surveillance system to allow for real-time access and live monitoring of the marihuana business via a secure web-based portal.
(b) Maintain surveillance recordings in a manner that allows the agency to view and obtain copies of the recordings immediately on request.
(1312) A licensee
shall maintain a video surveillance system equipped with a failure notification
system that provides notification to the licensee of anyan
interruption or failure of the video surveillance system or video surveillance
system storage device.
(1413) A licensee
shall maintain a log of the recordings, whichthat includes all of
the following:
(a) The identity of the employee or employees responsible for monitoring the video surveillance system.
(b) The identity of the
employee who removed anya recording from the video surveillance
system storage device and the time and date it was removed.
(c) The identity of the employee
who destroyed anya recording.
(1514) The
requirements of this rule do not apply to the following license types under the
MRTMA:
(a) A designated consumption establishment applicant or licensee.
(b) A marihuana event organizer applicant or licensee.
(c) A temporary marihuana event applicant or licensee.
R 420.210 Prohibitions Building
and fire safety.
Rule 10210. (1)
Except for designated consumption establishments or temporary marihuana events
licensed under the MRTMA, a marihuana business must not have marihuana products
that are not identified and recorded in the statewide monitoring system
pursuant to these rules. A licensee shall not transfer or sell a marihuana
product that is not identified in the statewide monitoring system pursuant to
these rules.
(2) Except for a designated
consumption establishment or temporary marihuana event licensed under the MRTMA,
a marihuana business must not have any marihuana product without a batch number or identification tag or label pursuant to
these rules. A licensee shall immediately tag, identify, or record as part of
a batch in the statewide monitoring system any marihuana product as provided in
these rules.
(3) A licensee shall not
reassign or subsequently assign a tag to another package that has been
associated with a package in the statewide monitoring system.
(4) A licensee shall not
allow a physician to conduct a medical examination or issue a medical
certification document at a marihuana business for the purpose of obtaining a
registry identification card.
(5) A violation of these
rules may result in sanctions or fines, or both, in accordance with the acts
and these rules. (1) An applicant’s proposed marihuana business and a
licensee’s marihuana business are subject to inspection by a state building
code official, state fire official, or code enforcement official to confirm
that no health or safety concerns are present.
(2) A state building code official, or the official’s authorized designee, may conduct prelicensure and post-licensure inspections to ensure that applicants and licensees comply with the Stille-DeRossett-Hale single state construction code act, 1972 PA 230, MCL 125.1501 to 125.1531; the skilled trades regulation act, 2016 PA 407, MCL 339.5101 to 339.6133; 1967 PA 227, MCL 408.801 to 408.824; and 1976 PA 333, MCL 338.2151 to 338.2160.
(3) A person shall not operate a marihuana business unless a permanent certificate of use and occupancy is issued by the appropriate enforcing agency. A temporary certificate of use and occupancy may be accepted at the discretion of the agency.
(4) An applicant or licensee shall not operate a marihuana business unless the proposed marihuana business or marihuana business has passed the prelicensure fire safety inspection by the BFS. The state fire marshal, or the state fire marshal’s authorized designee, may conduct prelicensure and post-licensure inspections of a marihuana business. An applicant or licensee shall comply with all of the following:
(a) A BFS inspection may be conducted at any reasonable time to ensure fire safety compliance. A BFS inspection may be annual or biannual and may result in the required installation of fire suppression devices or other means necessary for adequate fire safety under state standards.
(b) The BFS may require a marihuana business to obtain operational permits, including, but not limited to, any of the following:
(i) Carbon dioxide systems used in beverage dispensing applications, amended for cultivation use and extraction.
(ii) Compressed gases.
(iii) Combustible fibers.
(iv) Flammable and combustible liquids.
(v) Fumigation and insecticidal fogging.
(vi) Hazardous materials.
(vii) High piled storage or high rack system cultivation.
(viii) Liquefied petroleum (LP) gas.
(c) For specific installation or systems, the BFS may require marihuana businesses to obtain construction permits, including, but not limited to, any of the following:
(i) Building construction.
(ii) Electrical, mechanical, plumbing, boiler, and elevator.
(iii) Compressed gases.
(iv) Flammable and combustible liquids.
(v) Hazardous materials.
(vi) Liquified petroleum (LP) gas.
(vii) Automatic fire extinguishing or suppression systems.
(viii) Fire alarm and detections systems.
(ix) Related equipment found during fire safety inspections.
(5) The BFS may conduct a fire safety inspection of a marihuana business at any reasonable time to ensure compliance with the NFPA 1, 2021 edition, entitled “Fire Code,” which is adopted by reference in R 420.2.
(6) Producers, cultivators, laboratories, marihuana microbusinesses, and class A marihuana microbusinesses shall install exhaust ventilation systems to mitigate noxious gasses or other fumes used or created as part of a production process or operations. Exhaust and ventilation equipment must be appropriate for the hazard involved and comply with NFPA 1 and R 408.30901 to R 408.30998.
(7) In addition to meeting all the requirements in subrules (1) to (6) of this rule, cultivators, producers, laboratories, marihuana microbusinesses, class A marihuana microbusinesses, and designated consumption establishments shall also comply with both of the following:
(a) Allow the agency or its authorized agents, or the state fire marshal or the state fire marshal’s authorized designee, to enter and inspect a cultivator, producer, laboratory, marihuana microbusiness, class A marihuana microbusiness, or designated consumption establishment at any reasonable time.
(b) Have a fire safety inspection conducted, in addition to inspections required under the acts and these rules, if any of the following occur:
(i) Modifications to the grow areas, rooms and storage, extraction equipment and process rooms, or marihuana-infused product processing equipment within a marihuana business.
(ii) Changes in occupancy.
(iii) Material changes to a new or existing cultivator, producer, marihuana microbusiness, class A marihuana microbusiness, or designated consumption establishment, including changes made prelicensure and post-licensure.
(iv) Changes in extraction methods and processing or grow areas and building structures.
(8) The requirements of this rule do not apply to a marihuana event organizer applicant or marihuana event organizer licensee.
R 420.211 Marihuana product
destructiondisposal and waste management.
Rule 11211. (1) A
marihuana productMarihuana waste that is to be destroyed or is
considered waste must be rendered into an unusable and unrecognizable form
through grinding or another method as determined by the agency that incorporates
combines the marihuana product waste with 1 or more of the
following types of non-consumable solid waste so that the resulting mixture is
not lessmore than 50% non-marihuana productmarihuana
waste:
(a) Paper waste.
(b) Plastic waste.
(c) Cardboard waste.
(d) Food waste.
(e) Grease or other compostable oil waste.
(f) Fermented organic matter or other compost activators.
(g) Soil.
(h) Other waste approved in writing by the agency.
(2) Marihuana plant waste,
including roots, stalks, leaves, and stems that have not been processed with a
solvent must be rendered into an unusable and unrecognizable form through
grinding or another method as determined by the agency that incorporates the
marihuana plant waste with 1 or more of the following types of compostable
waste so that the resulting mixture is not less than 50% non-marihuana plant
waste:
(a) Food waste.
(b) Yard waste.
(c) Vegetable based grease
or oils.
(d) Other compostable
wastes approved by the agency.
(3) A(2)
Notwithstanding other provisions in this rule, a licensee shall managehandle
and dispose of all waste that is hazardous waste pursuant tounder
part 111 of the natural resources and environmental protection act, 1994 PA
451, MCL 324.11101 to 324.11153.
(4) A marihuana product
rendered unusable and unrecognizable and, therefore, considered waste, and
marihuana plant waste must be recorded in the statewide monitoring system.
(53) A licensee
shall not sell marihuana waste, or marihuana plant waste, or
marihuana products that are to be destroyed, or that the agency orders
destroyedto anyone other than a person that owns or operates a method of
disposal under subrule (5) of this rule.
(4) A licensee shall dispose of marihuana waste and marihuana plant waste in a secured waste receptacle. Doors, hatches, or lids that provide access to the contents of the waste receptacle must be secured with a lock.
(65) Except as
provided in subrule (6) of this rule, Aa licensee shall
dispose of marihuana product waste and marihuana plant waste in a
secured waste receptacle using 1 or more of the following methods
that complies with applicable state and local laws and regulations:
(a) A licensed municipal solid waste landfill.
(c) An anaerobic digester that
has specific approval under part 115 of the natural resources and environmental
protection act, 1994 PA 451, MCL 324.11501 to 324.1155411587, to
accept the material.
(d) An in-state municipal
solid waste or hazardous waste incinerator that has beenis permittedallowed
under part 55 of the natural resources and environmental protection act, 1994
PA 451, MCL 324.5501 to 324.5542.
(6) A grower, with agency approval, may dispose of marihuana plant waste as compost feedstock or using another organic waste disposal method at their marihuana business location in compliance with part 111 of the natural resources and environmental protection act, 1994 PA 451, MCL 324.11101 to 324.11153.
(7) A licensee shall dispose of all marihuana waste and marihuana plant waste within 90 days after generating the marihuana waste or marihuana plant waste.
(7) A licensee shall dispose
of wastewater generated during the cultivation of marihuana and the processing
of marihuana products in a manner that complies with applicable state and local
laws and regulations.
(8) A licensee shall maintain
accurate and comprehensive records regarding marihuana product waste,
and marihuana plant waste that accounts for, reconciles, and evidences all waste
activity related to the disposal of marihuana waste and marihuana plant
waste. The agency may publish guidance on marihuana product waste
management.
(9) As used in this rule,
“unrecognizable” means marihuana product rendered indistinguishable from any
other plant material. A licensee may receive used vape cartridges and
recycle the cartridges if the licensee disposes of perceptible marihuana waste
inside the cartridges before recycling the cartridges.
(10) Under the MRMTA, a
licensed marihuana microbusiness, class A marihuana microbusiness, or marihuana
retailer who participates in a temporary marihuana event shall destroy and
dispose of any marihuana product that is considered waste, and any marihuana
plant waste, resulting from the licensee’s activities during the event
according to the applicable provisions in this rule.
(11) Except for the
marihuana product waste specified in subrule (10) of this rule, a marihuana
event organizer who holds a temporary marihuana event under the MRTMA is
responsible for destroying and disposing of any marihuana product waste and
marihuana plant waste that results from the event. All marihuana waste must be
rendered unusable and unrecognizable and disposed of in accordance with this
rule and in compliance with all applicable state and local laws and
regulations.
(12) Under the MRMTA, a
licensed designated consumption establishment shall destroy and dispose of any
marihuana product left at the establishment that is considered waste and any
marihuana plant waste, in accordance with this rule and in compliance with all
applicable state and local laws and regulations. The designated consumption
establishment shall maintain a log of any marihuana product that is considered
waste, and marihuana plant waste, which must include a description of the waste
and the amount and the manner in which it was disposed. The designated
consumption establishment licensee shall make the log available to the agency
upon request.
(13) Nothing in these rules
prohibits a grower, with agency approval, from disposing of marihuana plant
waste as compost feedstock or in another organic waste method at their
marihuana business in compliance with part 111 of the natural resources and environmental
protection act, 1994 PA 451, MCL 324.11101 to 324.11153.
R 420.212 Storage of marihuana product.
Rule 12212. (1) Except
as provided in subrule (5) of this rule, Allall marihuana productsat
a marihuana business must be stored at a marihuana business in a secured
limited-access area or restricted access area and must be
identified and tracked consistently in the statewide monitoring system under
these rules.
(2) All containers used to
store marihuana products for transfer or sale between marihuana
businesses must be clearly marked, labeled, or tagged, if applicable, and
enclosed on all sides in secured containers. The secured containers must be
latched or locked in a manner to keep all contents secured within. Each
secured container must be identified and tracked in accordance with the acts
and these rules. The container must be secured by a locked closed lid or
door, or sealed by a tamper-proof tape that indicates if the marihuana had been
tampered with during transport.
(3) All chemicals, or
solvents, and toxic or flammable materials must be maintained in
closed containers and stored separatelyin separate storage areas
from marihuana or materials used in direct contact with marihuana
products and kept in a closed container in locked storage areas.
(4) Marihuana-infused
products, edible marihuana products, or materials used in direct contact with
the marihuana-infused products or edible marihuana products, must have separate
storage areas from toxic or flammable materials.
(54) Marihuana
products not in final packaging must be stored separately from other types
of marihuana product in compliance with these rules.
(65) A marihuana
sales location shall store all marihuana products for transfer or salethat
is displayed for sale behind a counter or other barrier separated from
stock rooms.
(6) All marihuana stored at a marihuana business must be identified and tracked in the statewide monitoring system.
(7) A laboratory shall
establish an adequate chain of custody and instructions for sample and storage
requirements.
(8) A licensee shall ensure
that any stock or storage room meets the security requirements of these rules
and any other applicable requirements in the acts and these rules.
R 420.213 Marihuana
microbusiness and class A marihuana microbusiness operation Standard
operating procedures.
Rule 13213. As
applicable, a marihuana microbusiness and class A marihuana microbusiness
licensee shall operate the corresponding areas of a marihuana microbusiness or
class A marihuana microbusiness in compliance with the operation requirements
of a marihuana retailer, a marihuana grower, or a marihuana processor as
provided for in MRTMA and these rules. A marihuana microbusiness and class A
marihuana microbusiness, if engaging in delivery, shall operate in accordance
with R 420.207. (1) A licensee shall have up-to-date, written standard
operating procedures on site at all times and follow the standard operating
procedures when engaging in the operations and activities of the marihuana
business.
(2) Standard operating procedures must detail a marihuana business’ operations and activities necessary for the marihuana business to comply with the acts and these rules.
(3) If the agency determines that a standard operating procedure contains inaccurate information or does not comply with these rules and safe food management guidelines, if applicable, the licensee may be required to correct the practice immediately and update the standard operating procedures within a time frame determined by the agency.
(4) A licensee is responsible for creating and maintaining documentation that is sufficient to demonstrate that the licensee’s operations and activities follow the licensee’s standard operating procedures.
R 420.214 Transfer of
marihuana between equivalent licenses Closed licenses.
Rule 14214. (1)
The agency may authorize licensees who hold equivalent licenses under the MRTMA
with common ownership to transfer marihuana product between the inventory of
their marihuana facility and the inventory of their marihuana establishment.
(2) The following licensees
who hold the following equivalent licenses with common ownership may accept the
transfer of medical marihuana product under subrule (1) of this rule:
(a) Class A marihuana
growers.
(b) Class B marihuana
growers.
(c) Class C marihuana growers.
(d) Marihuana processors.
(e) Marihuana retailers.
(4) A licensee shall
transfer marihuana product between equivalent licenses with common ownership in
accordance with these rules and any requirements published by the agency.
(5) A licensee shall track
the transfer of product between equivalent licenses with common ownership in
the statewide monitoring system in accordance with these rules and any
requirements published by the agency. Marihuana plants transferred pursuant to
this rule count towards the authorized total amount of marihuana plants for a
licensed cultivator.
(6) Marihuana product
transferred to an equivalent license with common ownership may only be sold or
transferred in accordance with the acts and these rules.
(7) A licensee in receipt
of transferred marihuana product shall track the marihuana product sold or transferred
in accordance with these rules. A marihuana business shall ensure that
no marihuana remains at the location of the marihuana business at the time the
marihuana business’ license is closed by doing 1 or both of the following:
(a) Transfer marihuana in the possession of the marihuana business to another marihuana business.
(b) Dispose of marihuana in the possession of the marihuana business and provide the agency with proof of disposal.
R 420.214a Internal
analytical testing. Rescinded.
Rule 14a. (1) A licensee may
designate a space to perform internal analytical testing on marihuana or a
marihuana product grown or produced by the marihuana business, if all of the
following are met:
(a) The designated internal
analytical testing space is fully partitioned from all other licensed
activities at the marihuana business.
(b) The designated internal
analytical testing space complies with all of the requirements of R 420.209.
(c) If a licensee with a
designated space for internal analytical testing is co-located with another
licensee, product from only 1 license may be in the designated space at a time.
(d) Internal analytical
testing may be performed only on a product grown, harvested, or processed by
licensees under common ownership.
(3) All marihuana or a
marihuana product used for internal analytical testing must have a batch number
or an identification tag or label as assigned by the statewide monitoring
system affixed to it.
(4) No marihuana or
marihuana product other than samples for testing may be stored in the internal
analytical testing space.
(5) Marihuana or a marihuana
product that has undergone internal analytical testing must be disposed of in
compliance with R 420.211.
(6) Results of internal
analytical testing may not be entered into the statewide monitoring system.
(7) Any batch of marihuana
or a marihuana product that has undergone internal analytical testing must
undergo full safety compliance testing, with passing test results entered into
the statewide monitoring system, prior to being sold or transferred.
(8) Any batch of marihuana
or a marihuana product that has undergone internal analytical testing must
undergo full safety compliance testing, with failing test results entered into
the statewide monitoring system, prior to making a request for remediation.
(9) The results of internal
analytical testing may not be used to label a product under R 420.504.
R 420.214b Adverse reactions.
Rescinded.
Rule 14b. (1) A licensee
shall notify the agency within 1 business day of becoming aware or within 1
business day of when the licensee should have been aware of any adverse
reactions to a marihuana product sold or transferred by any licensee.
(2) A licensee shall enter
into the statewide monitoring system within 1 business day of becoming aware of
or within 1 business day of when the licensee should have been aware of any
adverse reactions to a marihuana product sold or transferred by any licensee.
R 420.214c Product returns. Rescinded.
Rule 14c. (1) A marihuana
sales location may accept the return of marihuana product that is reported to
have caused an adverse reaction or is determined to be defective.
(2) A marihuana sales
location must have a written policy for the return of marihuana product that
contains, at a minimum, the following:
(a) Product returned to a
marihuana sales location must be tracked consistently in the statewide
monitoring system as waste in compliance with R 420.211.
(b) Product returned to a
marihuana sales location must be destroyed in compliance with R 420.211 within
90 calendar days of when the marihuana business became aware of the fact that
the product must be destroyed.
(c) Product returned to a
marihuana sales location cannot be re-sold, re-packaged, or otherwise
transferred to a customer or another marihuana business.
(d) Product returned to a
marihuana sales location is prohibited from being returned to the marihuana
sales location by way of a delivery driver.
(e) A marihuana sales
location that does not comply with these rules may be subject to disciplinary
proceedings.
(f) A marihuana retailer
may return a marihuana product that is past its expiration date to the
marihuana processor who produced the marihuana product for destruction instead
of destroying the marihuana product.
R 420.215 Severability Internal
analytical testing.
Rule 15215. If
any rule or subrule of these rules, in whole or in part, is found to be invalid
by a court of competent jurisdiction, such decision will not affect the
validity of the remaining portion of these rules. (1) A marihuana
business may perform internal analytical testing on marihuana grown or
processed by that marihuana business.
(2) A marihuana business shall perform analytical testing under subrule (1) of this rule in a designated internal analytical testing space that meets all of the following requirements:
(a) The designated internal analytical testing space must be fully partitioned from all other licensed activities at the marihuana business.
(b) If a marihuana business with a designated space for internal analytical testing is operating at the same location as another marihuana business, marihuana from only 1 marihuana business must be in the designated internal analytical testing space at 1 time.
(c) No marihuana other than samples for testing may be stored in the internal analytical testing space.
(3) All marihuana used for internal analytical testing must have a batch number or tag affixed to it.
(4) Marihuana that has undergone internal analytical testing must be disposed of in compliance with R 420.211.
(5) Marihuana that has undergone internal analytical testing must pass full safety compliance testing before it can be sold or transferred.
(6) Marihuana that has undergone internal analytical testing must undergo full safety compliance testing before making a request for remediation.
(7) The results of internal analytical testing must not be included on the label required under R 420.405.
R 420.216 Transferring and transporting marihuana.
Rule 216. (1) A licensee shall use a marihuana transporter to transfer marihuana to another licensee, unless 1 of the following applies:
(a) A cultivator is transferring seeds, seedlings, tissue cultures, or immature plants to another marihuana grower.
(b) The licensee occupies the same location as the other licensee and the marihuana is transferred using only private real property without accessing public roadways.
(c) The licensee is a marihuana safety compliance facility and is collecting and transporting marihuana to or from another licensee for testing under part 5 of these rules and as provided in section 505 of the MMFLA, MCL 333.27505.
(d) The licensee is transferring trade samples to another licensee, if the total amount of the trade samples being transported does not exceed 15 ounces of marihuana. Of the 15 ounces, not more than 60 grams may be marihuana concentrate.
(2) A licensee licensed under the MRTMA shall use a marihuana secure transporter when transferring marihuana under this rule and a licensee licensed under the MMFLA shall use a secure transporter when transferring marihuana under this rule.
(3) A licensee transporting marihuana to or from the site of a temporary marihuana event shall use a marihuana secure transporter, unless the amount of marihuana being transported does not exceed 15 ounces of marihuana. Of the 15 ounces, not more than 60 grams may be marihuana concentrate.
(4) A marihuana business that transfers marihuana to another marihuana business, other than transfers to a laboratory for testing under part 5 of these rules, shall do all of the following:
(a) Initiate the procedures to transfer marihuana to the other marihuana business within 30 minutes after the marihuana transporter’s arrival at the marihuana business.
(b) If transferring flower, weigh the flower not more than 48 hours before transferring the flower and, if necessary, adjust the quantity of flower being transferred to ensure that the weight of the flower being transferred is the same as the weight recorded in the statewide monitoring system.
(5) A marihuana business that receives a transfer of marihuana from another marihuana business shall do all of the following:
(a) Initiate the procedures to receive the marihuana from another marihuana business within 30 minutes after the marihuana transporter’s arrival at the receiving marihuana business.
(b) Verify that the transfer of marihuana received from another marihuana business is accurate within 72 hours after receiving the shipment.
(6) If a transfer requires special approval from the agency, a marihuana business shall transfer the marihuana within 3 days after receiving approval from the agency.
R 420.217 Product returns.
Rule 217. (1) A marihuana sales location may accept the return of marihuana that is reported to have caused an adverse reaction, is determined to be defective, or is recalled.
(2) A marihuana delivery driver shall not accept marihuana to return to a marihuana sales location.
(3) Marihuana returned to a marihuana sales location must be disposed of as marihuana waste.
(4) A marihuana sales location may return marihuana that is past its expiration date to the producer from whom it obtained the marihuana for disposal.
R 420.218 Prohibitions.
Rule 218. (1) Except for marihuana in the possession of a marihuana customer at a designated consumption establishment or temporary marihuana event, a marihuana business shall not have marihuana at its marihuana business location that is not tagged and recorded in the statewide monitoring system.
(2) A marihuana business shall not transfer or sell marihuana that is not tagged and identified in the statewide monitoring system.
(3) If a tag is assigned to a package of marihuana, a marihuana business shall not reassign or subsequently assign that tag to another package of marihuana.
(4) A marihuana business shall not allow a physician to conduct a medical examination or issue a medical certification document at a marihuana business for the purpose of obtaining a registry identification card.
R 420.218a Prohibition on converting cannabinoids.
Rule 218a. (1) A marihuana business shall not convert a cannabinoid extracted from a cannabis plant into a different cannabinoid using a chemical reaction. This subrule does not prohibit producing a cannabinoid via decarboxylation of a naturally occurring acidic form of a cannabinoid into the corresponding neutral cannabinoid through the use of heat or light, if both of the following requirements are met:
(a) No chemical reagents or catalysts are used to produce the cannabinoid.
(b) No other chemical change occurs.
(2) A marihuana business shall not sell or transfer marihuana that contains a cannabinoid produced in violation of subrule (1) of this rule.
(3) A marihuana business shall dispose of marihuana produced in violation of subrule (1) of this rule.
R 420.219 Banned chemicals.
Rule 219. A cultivator or a producer shall not use a chemical or marihuana containing a chemical listed in table 4 of R 420.306a within the marihuana business location for any purpose.
R 420.220 Updating standards.
Rule 220. The agency may update or issue new standards as necessary to protect the health, safety, and welfare of marihuana customers and the public. A marihuana business shall comply with all new or updated standards issued by the agency within 6 months of their adoption by the agency unless there is an identifiable public health or safety risk.
R 420.221 Compliance with 21 CFR 117.
Rule 221. (1) A producer of an edible marihuana product shall comply with current good manufacturing practice, hazard analysis, and risk-based preventive controls for human food, 21 CFR part 117, subparts A and B.
(2) Not later than 3 years after the effective date of this rule, a marihuana business that possesses marihuana that is not sealed in a package shall comply with current good manufacturing practice, hazard analysis, and risk-based preventive controls for human food, 21 CFR part 117, subparts A and B. This subrule does not apply to designated consumption establishments or marihuana waste.
(3) Not later than 5 years after the effective date of this rule, a producer of an edible marihuana product shall comply with current good manufacturing practice, hazard analysis, and risk-based preventive controls for human food, 21 CFR part 117, subparts C, D, E, F and G.
DEPARTMENT OF
LICENSING AND REGULATORY AFFAIRS
MARIJUANA REGULATORY
AGENCY
MARIHUANAPART
5. SAMPLING AND TESTING
(By authority conferred on the
executive director of the marijuana regulatory agency by section 206 of the
medical marihuana facilities licensing act, 2016 PA 281, MCL 333.27206,
sections 7 and 8 of the Michigan Regulation and Taxation of Marihuana Act, 2018
IL 1, MCL 333.27957 and 333.27958, and Executive Reorganization Order No.
2019-2, MCL 333.27001)
R 420.301 Definitions.
Rule 1301. (1)
As used in these rulesthis part:
(a) “Action limit” means
the maximum permissible level of a contaminant in marihuana product allowable
by the agency.
(b) “Acts” refers to the
medical marihuana facilities licensing act, 2016 PA 281, MCL 333.27101 to
333.27801, and the Michigan Regulation and Taxation of Marihuana Act, 2018 IL
1, MCL 333.27951 to 333.27967, when applicable.
(c) “Agency” means the
marijuana regulatory agency.
(d) “Batch” means all
marihuana product of the same variety that has been processed together and
exposed to substantially similar conditions throughout processing.
(e) “Cultivator” refers to
a grower under the medical marihuana facilities licensing act or a marihuana
grower under the Michigan Regulation and Taxation of Marihuana Act, or both.
(f) “Employee” means,
except as otherwise provided in these rules, a person performing work or
service for compensation. “Employee” does not include an individual providing
trade or professional services who is not normally engaged in the operation of
a marihuana establishment.
(g) “Final form” means the
form a marihuana product is in when it is available for sale by a marihuana
sales location not including consumer packaging. For marihuana products
intended for inhalation, “final form” means the marihuana concentrate in an
e-cigarette or a vaping device.
(h) “Good agricultural
collection practices” or “GACP-GMP” means the World Health Organization’s or
the American Herbal Products Association’s guidelines regarding the safety,
efficacy, and sustainability of medicinal plant material being used in herbal
medicines.
(i) “Good manufacturing
practices” or “GMP” means the Food and Drug Administration’s formal regulations
regarding the design, monitoring, control, and maintenance of manufacturing
processes and facilities. They are designed to ensure that products
manufactured are to specific requirements including identity, strength,
quality, and purity.
(j) “Harvest batch” means a
designated quantity of harvested marihuana, all of which is identical in strain
and has been grown and harvested together and exposed to substantially similar
conditions throughout cultivation.
(k) "Immature plant”
means a nonflowering marihuana plant that is no taller than 8 inches from the
growing or cultivating medium and no wider than 8 inches produced from a
cutting, clipping, tissue culture, or seedling that is in a growing or
cultivating medium or in a growing or cultivating container.
(l) “Inactive ingredients”
means binding materials, dyes, preservatives, flavoring agents, and any other
ingredient that is not derived from the plant Cannabis sativa L.
(m) “Laboratory” refers to
both a safety compliance facility under the medical marihuana facilities
licensing act and a marihuana safety compliance facility under the Michigan
Regulation and Taxation of Marihuana Act.
(n) “Limit of quantitation”
or “LOQ” means the minimum concentration or mass of an analyte in a given
matrix that can be reported as a quantitative result.
(o) “Marihuana business”
refers to a marihuana facility under the medical marihuana facilities licensing
act or a marihuana establishment under the Michigan Regulation and Taxation of
Marihuana Act, or both.
(p) “Marihuana
establishment” means a e a marihuana grower, marihuana safety compliance
facility, marihuana processor, marihuana microbusiness, marihuana retailer,
marihuana secure transporter, marihuana designated consumption establishment,
or any other type of marihuana-related business licensed by the agency under
the Michigan Regulation and Taxation of Marihuana Act.
(q) “Marihuana facility”
means a location at which a licensee is licensed to operate under the medical
marihuana facilities licensing act.
(r) “Marihuana product”
means marihuana or a marihuana-infused product, or both, as those terms are
defined in the act unless otherwise provided for in these rules.
(s) “Marihuana sales
location” refers to a provisioning center under the medical marihuana
facilities licensing act or a marihuana retailer under the Michigan Regulation
and Taxation of Marihuana Act, or both.
(t) “Marihuana tracking
act” means the marihuana tracking act, 2016 PA 282, MCL 333.27901 to 333.27904.
(u) “Medical marihuana
facilities licensing act” or “MMFLA” means the medical marihuana facilities
licensing act, 2016 PA 281, MCL 333.27101 to 333.27801.
(v) “Michigan Regulation
and Taxation of Marihuana Act” or “MRTMA” means the Michigan Regulation and
Taxation of Marihuana Act, 2018 IL 1, MCL 333.27951 to 333.27967.
(w) “Package tag” means an
RFID tag supplied through the statewide monitoring system for the purpose of
identifying a package containing a marihuana product.
(x) “Plant tag” means an
RFID tag supplied through the statewide monitoring system for the purpose of
identifying an individual marihuana plant.
(y) “Pre-test” means to
perform full compliance testing on samples, without reporting the results to
the agency, and reporting results of subsequent testing to the agency.
(z) “Proficiency test”
means a test that determines the performance of individual laboratories for
specific tests or measurements and is used to monitor laboratories’
performance.
(aa) “Producer” refers to
both a processor under the medical marihuana facilities licensing act and a
marihuana processor under the Michigan Regulation and Taxation of Marihuana
Act.
(bb) “Production batch”
means a designated quantity of marihuana product, all of which was processed together,
is homogeneous, identical in color, flavor, and other characteristics, and was
processed under similar conditions throughout processing.
(cc) “These rules” means
the administrative rules promulgated by the agency under the authority of the
medical marihuana facilities licensing act, the marihuana tracking act, the
Michigan Regulation and Taxation of Marihuana Act, and Executive Reorganization
Order No. 2019-2, MCL 333.27001.
(dd) “Tag” or “RFID tag”
means the unique identification number or Radio Frequency Identification (RFID)
issued to a licensee by the statewide monitoring system for tracking,
identifying, and verifying marihuana plants, marihuana products, and packages
of marihuana product in the statewide monitoring system.
(ee) “Target analyte” means
a non-marihuana inactive ingredient designated for analysis.
(2) Terms defined in the
acts have the same meanings when used in these rules unless otherwise
indicated. (a) “Accuracy” means a combination of the bias and precision
of an analytical procedure, which reflects the closeness of a measured value to
a true value. For the purposes of laboratory certification, accuracy means the
closeness of a measured value to its generally accepted value or its value
based on an accepted reference standard.
(b) “Action limit” means the maximum permissible level of contaminant in a marijuana product.
(c) “Analyte” means a substance or chemical constituent that is of interest in an analytical procedure and is being identified or measured.
(d) “Analytical sensitivity” means the assay’s ability to detect very low concentrations of a given substance.
(e) “Analytical selectivity” means the degree to which a method can quantify the analyte of interest in the presence of other analytes, matrices, or other potentially interfering materials.
(f) “Analytical testing batch” means a group of 20 samples that are derived from a single production batch that is submitted to a laboratory for testing.
(g) “Bias” means a measure of systematic or determinative error in an analytical method that is determined by assessing the percent recovery of spiked samples.
(h) “Calibration” means comparing a signal from an unknown concentration of an analyte to that from a known concentration of the same or similar analyte.
(i) “Chain of custody” means the chronological documentation showing the collection, custody, control, transfer, analysis, and disposition of a sample.
(j) “CFU/g” means colony forming units per gram.
(k) “Continuing calibration verification” means a standard analyzed during an analytical batch, at the end of an analytical batch, or both, to verify that the instrument response has not drifted from the initial calibration.
(l) “Inhalable compound concentrate” means either of the following:
(i) A marihuana product that is created from multiple categories of inhalable products that have been combined into a single final form intended for inhalation.
(ii) A marihuana product that is created from the combination of multiple marihuana concentrates from different sources and that is intended for inhalation.
(m) “Interfering substance” means a substance other than the analyte of interest that at the given concentration may cause a systematic error in the analytical result.
(n) “Laboratory fortified blank” or “LFB” means an aliquot of reagent water or other blank matrix to which known quantities of the method analytes and all the preservation compounds are added, which is processed and analyzed exactly like a sample for the purpose of determining whether the methodology is in control, and whether the laboratory is capable of making accurate and precise measurements.
(o) “Laboratory fortified matrix” means an aliquot of a preserved field sample to which known quantities of the method analytes are added.
(p) “Laboratory fortified matrix duplicate” means a duplicate preserved field sample used to prepare the laboratory fortified matrix, which is fortified, extracted, and analyzed identically to the laboratory fortified matrix.
(q) “Laboratory reagent blank” means a mixture of a solvent or solvents, reagent or reagents, or both, that would be presented to the detector for analysis of a test sample and that is analyzed to determine if it contributes to the measurement signal.
(r) “Linear calibration range” or “LCR” means the region of a calibration curve within which a plot of the concentration of an analyte versus the response of that particular analyte remains linear and the correlation coefficient of the line is approximately 1, and for which the plot may be normal-normal, log-normal, or log-log when allowed by the analytical method, and for which the response of the analyte's signal versus concentration deviates from the line at the upper and lower bounds.
(s) “Limit of detection” or “LOD” means the lowest signal or lowest corresponding quantity to be determined or extracted from the signal that is observed with a sufficient degree of confidence and statistical significance and can be distinguished from background noise by a particular instrument.
(t) “Limit of quantitation” or “LOQ” means the minimum concentration or mass of an analyte in a given matrix that can be reported as a quantitative result that is specific to a matrix, method, or analyte, and is mathematically defined as equal to 10 times the standard deviation of the results for a series of replicates used to determine a justifiable limit of detection.
(u) “Marihuana product intended for inhalation” means marihuana concentrate that is intended to be inhaled using an electronic cigarette or vaping device.
(v) “Method detection limit” means the minimum concentration of a substance that can be measured and reported with 99% confidence that the analyte concentration is greater than zero and is determined from analysis of a sample in a target matrix containing the analyte.
(w) “Precision” means a measure of the random error associated with a series of repeated measurements of the same parameter within a sample and that describes the closeness with which multiple analyses of a given sample agree with each other that is determined by the absolute standard deviation, relative standard deviation, variance, coefficient of variation, relative percent difference, or the absolute range of a series of measurements.
(x) “Proficiency test” means a test that determines the performance of a laboratory for specific tests or measurements and that is used to monitor a laboratory’s performance.
(y) “Relative percent difference” means the relative difference between 2 quantities across different measurements or samples that is determined by subtracting 1 measurement from the other and taking the absolute value of the difference.
(z) “Reportable range” means the range between the concentration of the highest standard tested that exhibits acceptable results for linearity, accuracy, and precision, and the lowest standard tested that exhibits acceptable results.
(aa) “Reporting limit” means a number below which data is not reported and must be statistically determined.
(bb) “Representative sample” means a sample taken in a statistically random fashion from different parts of a larger batch in which different properties of the batch are proportionally represented and that accurately represents the characteristics of the larger batch.
(cc) “Sample matrix” or “matrix” means the general physical-chemical composition of a sample other than the analytes of interest.
(dd) “Standard deviation” means a measure of the degree of agreement or precision among replicate analytes of a sample.
(ee) “Statistical outlier” means an observation or data point that appears to deviate markedly from other members of the population in which it occurs and that must be verified using an approved statistical method at the 1% significance level.
(ff) “Target analyte” means a non-marihuana inactive ingredient designated for analysis.
(gg) “Validation” means the process of demonstrating or confirming the performance characteristics of a method of analysis that results in the specification of various aspects of reliability and applicability.
(hh) “Water activity” means the partial vapor pressure of water in a substance divided by the standard state partial vapor pressure or water.
R 420.302 Adoption by
reference Sampling; collection.
Rule 2302. (1)
The following codes, standards, or regulations of nationally recognized
organizations or associations are adopted by reference in these rules:
(a) AOAC International
Official Methods of Analysis, 21st edition. Copies of the adopted
provisions are available for inspection and distribution from the Association
of Official Analytical Collaboration (AOAC) International, 2275 Research
Boulevard, Suite 300, Rockville, Maryland, 20850, telephone number
1-800-379-2622, for the price of $870.00.
(b) National fire
protection association (NFPA) standard 1, 2021 edition, entitled “Fire Code,”
is adopted by reference as part of these rules. Copies of the adopted
provisions are available for inspection and distribution from the National Fire
Protection Association, 1 Batterymarch Park, P.O. Box 9101, Quincy,
Massachusetts, 02169, telephone number 1-800-344-3555, for the price of
$114.50.
(c) The International
Organization for Standardization (ISO), ISO 22000 / ISO/TS 22002-1:2009, Food
Safety Bundle, available for purchase at:
https://webstore.ansi.org/Standards/ISO/ISO22000TS22002FoodSafety, for the
price of $275.00.
(d) International
Organization for Standardization (ISO), ISO/IEC 17025:2017, General
Requirements for the Competence of Testing and Calibration Laboratories,
available at:
https://webstore.ansi.org/RecordDetail.aspx?sku=ISO%2fIEC+17025%3a2017, for the
price of $162.00.
(e) International
Organization for Standards (IS0), ISO/IEC 17065:2012, Conformity Assessment –
Requirements for Bodies Certifying Products, Processes and Services, available
at: https://webstore.ansi.org/Standards/ISO/ISOIEC170652012, for the price of
$175.00.
(f) International
Organization for Standards (IS0), ISO/IEC 17043:2010, Conformity Assessment –
General Requirements for Proficiency Testing, available at:
https://webstore.ansi.org/Standards/ISO/ISOIEC170432010, for the price of
$200.00.
(2) The standards adopted in
subrule (1)(a) to (d) of this rule are available for inspection and
distribution at the agency, located at 2407 North Grand River Avenue, Lansing,
Michigan, 48906. Copies of these standards may be obtained from the agency at
the cost indicated in subrule (1)(a) to (d) of this rule, plus shipping and
handling. (1) Before collecting a sample under this rule, a laboratory
shall develop a statistically valid sampling method to collect a representative
sample from a harvest batch or production batch of marihuana and submit the
method to the agency. The sampling method must be approved by the agency before
a lab may collect samples.
(2) A laboratory shall collect samples for testing using the method approved under subrule (1) of this rule.
(3) Before a laboratory collects a sample from a marihuana business, the marihuana business shall do either of the following:
(a) Weigh the harvest batch or production batch from which a sample is collected.
(b) Count the number of units of the production batch from which a sample is collected.
(4) A laboratory employee shall verify that the weight or number of units determined under subrule (3) of this rule is the same as the weight or number of units recorded in the statewide monitoring system.
(5) The marihuana business shall make the entirety of a harvest batch or production batch available for sampling.
(6) A laboratory employee shall physically collect a representative sample of a harvest batch or production batch of marihuana that meets the requirements of R 420.303.
(7) An employee of the marihuana business shall be physically present to observe the laboratory employee collect the sample throughout the entirety of the sample collection process.
(8) A marihuana business shall not do any of the following:
(a) Direct a laboratory employee to take a pre-selected sample.
(b) Attempt to influence the laboratory employee to deviate from the laboratory’s approved sampling method.
(c) Assist a laboratory employee in collecting a sample.
(d) Touch the marihuana or the sampling equipment while the laboratory employee is collecting a sample.
(e) Designate or indicate to the laboratory employee which portion of a sample should be used to perform a particular test.
(f) Interfere with a laboratory employee collecting a sample or attempt to prevent a laboratory from complying with the requirements of this rule.
(9) All sample collection must be conducted in view of a camera required under R 420.209. The marihuana business shall provide a laboratory employee collecting a sample with a location to collect samples that is within an unobstructed view of a camera. The laboratory employee shall collect samples in a way that the camera has an unobstructed view of the entire sample collection process.
(10) A laboratory shall not transfer a sample of a marihuana collected for testing to anyone other than the following:
(a) The marihuana business from which the sample was collected.
(b) Another laboratory for the purpose of performing a test required under this part of these rules on a subcontracted basis.
(c) The agency, on request.
R 420.303 Batch;
identification and testing Sample sizes.
Rule 3303. (1)
A cultivator shall uniquely identify each immature plant batch with a single
batch name and record the information in the statewide monitoring system. Each
immature plant batch must consist of no more than 100 immature plants.
(2) A cultivator shall tag
each individual plant that is greater than 8 inches in height from the growing
or cultivating medium or more than 8 inches in width with an individual plant
tag and record the identification information in the statewide monitoring
system.
(3) A cultivator shall
separate the plants as the plants go through different growth stages and ensure
that the plant tag is always identified with the plant throughout the growing
cycle so that all plants can be easily identified and inspected. A cultivator shall
ensure that identification information is recorded in the statewide monitoring
system in accordance with the acts, the marihuana tracking act, and these
rules.
(4) A cultivator shall
destroy the individual plant tag prior to packaging. Once a tagged plant is
harvested, it is part of a harvest batch so that a sample of the harvest batch
can be tested by a licensed laboratory as provided in R 420.304 and R 420.305.
A cultivator shall separate the harvest batch by product type and quarantine
the harvested batch from all other marihuana and marihuana products when the
marihuana batch has test results pending. A harvest batch must be easily
distinguishable from other harvest batches until the batch is broken down into
packages. A cultivator may not combine harvest batches.
(5) Before the cultivator
transfers or sells the marihuana product to a marihuana sales location, a
sample of the harvest batch must be tested for all required safety tests by a
licensed laboratory as provided in R 420.304 and R 420.305. All test results
must indicate passed in the statewide monitoring system before the marihuana is
packaged for sale. A marihuana product from harvest batches may not be
transferred or sold until tested, packaged, and tagged as required under
subrule (4) of this rule. A cultivator may not transfer or sell marihuana
under this rule to a marihuana sales location if the package contains more than
1 harvest batch.
(6) A cultivator may
transfer or sell marihuana to a producer without first being tested by a
laboratory if the marihuana product will be processed. After the producer has
processed the material, the producer shall have the sample tested for all
required safety tests pursuant to R 420.304 and R 420.305. A producer that
received a package under this rule that has not been processed may transfer
that package to another producer without having the package first tested by a
laboratory for extraction.
(7) After test results
indicate a passed test for all required safety tests and the harvest batch is
packaged, each package must have a package tag attached. A cultivator shall
ensure this information is placed in the statewide monitoring system in
accordance with the acts, the marihuana tracking act, and these rules.
(8) A cultivator shall not
transfer or sell any marihuana product that does not have a package tag
attached and is not recorded in the statewide monitoring system in accordance
with the acts, the marihuana tracking act, and these rules. (1) A
laboratory shall collect a sample size that is sufficient to complete all
required tests, but that is not less than the following:
(a) For a marihuana concentrate, the laboratory shall take the following number of 0.25-gram sample increments based on the production batch size:
(i) 12 increments for a production batch of 0.01 to 2 pounds.
(ii) 15 increments for a production batch of 2.01 to 3 pounds.
(iii) 18 increments for a production batch of 3.01 to 4 pounds.
(iv) 23 increments for a production batch of 4.01 to 10 pounds.
(v) 29 increments for a production batch greater than 10 pounds.
(b) For a marihuana-infused product, the laboratory shall take the following number of units based on the production batch size:
(i) 2 units for a production batch of up to 100 units.
(ii) 4 units for a production batch of 101 to 500 units.
(iii) 6 units for a production batch of 501 to 1,000 units.
(iv) 8 units for a production batch of 1001 to 5,000 units.
(v) 10 units for a production batch of 5,001 to 10,000 units.
(vi) 12 units for a production batch greater than 10,001 units.
(c) For a harvest batch, the laboratory shall take not less than 0.5% of the weight of the harvest batch.
(2) A laboratory may collect additional samples for the purposes of completing the required tests under R 420.306.
R 420.303a Producer and sales
location packaging and testing requirements. Rescinded.
Rule 3a. (1) A producer
shall give a marihuana product a new package tag anytime the marihuana product
changes form or is incorporated into a different product.
(2) A producer of a
marihuana product in its final form shall have the sample tested pursuant to R
420.304 and R 420.305. The producer shall quarantine products from all other
products when the product has test results pending. The producer shall not
transfer or sell a marihuana product to a marihuana sales location until after
test results entered into the statewide monitoring system indicate a passed
result for all required safety tests. Nothing in this subsection prohibits a
producer from transferring or selling a package in accordance with the
remediation protocol provided by the agency and these rules.
(3) A marihuana sales
location may sell or transfer a marihuana product only to a marihuana customer
under both of the following conditions:
(a) The marihuana product
has received passing results for all required safety tests in the statewide
monitoring system.
(b) The marihuana product
bears the label required under the acts and these rules for retail sale.
R. 420.304 Sampling; testingSamples;
chain of custody and transportation.
Rule 4304. (1)
A laboratory shall test samples as provided in the acts and these rules.
(2) A laboratory shall
collect samples of a marihuana product from another marihuana business, and
that marihuana business shall not interfere or prevent the laboratory from
complying with all of the following requirements:
(a) The laboratory shall
physically collect the sample of the marihuana product from another marihuana
business to be tested at the laboratory. A laboratory shall comply with all
the following:
(i) The laboratory shall
ensure that samples of the marihuana product are identified in the statewide
monitoring system and placed in secured, sealed containers that bear the
labeling required under these rules.
(ii) The route plan and
manifest must be entered into the statewide monitoring system, and a copy must
be carried in the transporting vehicle and presented to a law enforcement
officer upon request.
(iii) The marihuana must
be transported in 1 or more sealed containers and not be accessible while in
transit.
(iv) The vehicle a
laboratory is using to transport samples of marihuana product must not bear
markings or other indication that it is carrying marihuana or a
marihuana-infused product.
(c) The maximum harvest
batch is 50 pounds. At least 50% of the sample taken must be homogenized for
testing. The agency may publish sample sizes for marihuana products being
tested.
(d) For a marihuana
concentrate a laboratory must take a sample increment of 0.25 grams. The
laboratory must take the following number of increments based upon the
production batch size:
(i) 12 increments for a
production batch of 1 to 2 pounds.
(ii) 15 increments for a
production batch of 2 to 3 pounds.
(iii) 18 increments for a
production batch of 3 to 4 pounds.
(iv) 23 increments for a
production batch of 4 to 10 pounds.
(v) 29 increments for a
production batch greater than 10 pounds.
(e) For marihuana-infused
products a laboratory must take the following number of units based upon the
production batch size:
(i) 2 units for a
production batch of up to 100 units.
(ii) 4 units for a
production batch of 101 to 500 units.
(iii) 6 units for a
production batch of 501 to 1000 units.
(iv) 8 units for a
production batch of 1001 to 5000 units.
(v) 10 units for a
production batch of 5001 to 10,000 units.
(vi) 12 units for a
production batch greater than 10,001 units.
(f) The laboratory shall
develop a statistically valid sampling method and have it approved by the
agency to collect a representative sample from each batch of marihuana product.
The laboratory shall have access to the entire batch for the purposes of
sampling.
(g) An employee of the
marihuana business from which marihuana product test samples are collected
shall be physically present to observe the laboratory employee collect the
sample of marihuana product for testing and shall ensure that the sample
increments are taken from throughout the batch.
(h) An employee of a
marihuana business shall neither assist the laboratory employee nor touch the
marihuana product or the sampling equipment while the laboratory employee is
obtaining the sample.
(i) After samples have been
selected, both the employee of the marihuana business that had the samples
collected and the employee from the laboratory shall sign and date the chain of
custody form, attesting to the following sample information:
(i) Marihuana product
name.
(ii) Weight of marihuana
product.
(iii) All marihuana
products and samples are correctly identified in the statewide monitoring
system.
(iv) If the product test
sample is obtained for a retest, the laboratory confirms that it is not
accepting a product test sample that is prohibited from being retested.
(j) A marihuana business
shall enter in the statewide monitoring system the marihuana product test
sample that is collected by a licensed laboratory, including the date and time
the marihuana product is collected and transferred. The laboratory shall enter
into the statewide monitoring system the test results within 3 business days of
test completion.
(k) If a testing sample is
collected from a marihuana business for testing in the statewide monitoring
system, that marihuana business shall quarantine the marihuana product that is
undergoing the testing from any other marihuana product at the marihuana
business. The quarantined marihuana product may not be packaged, transferred,
or sold until passing test results are entered into the statewide monitoring
system.
(l) Any marihuana product
that a laboratory collects for testing from a licensee under this rule may not
be transferred or sold to any other marihuana business other than the licensee
from whom the sample was collected. This provision does not apply to a
laboratory that engages another laboratory to perform certain safety tests on a
subcontracted basis.
(m) A laboratory may
collect additional sample material from the same licensee from which the
original sample was collected for the purposes of completing the required
safety tests as long as the requirements of this rule are met.
(n) The agency may publish
guidance that must be followed by marihuana businesses for chain of custody
documentation. (1) After a sample is collected under R 420.302, a
laboratory employee shall complete a chain-of-custody form that includes all of
the following information:
(a) The name of the harvest batch or production batch from which the sample was collected.
(b) One of the following:
(i) The weight of the harvest batch or production batch from which the sample was collected.
(ii) The number of units in the production batch from which the sample was collected.
(c) An attestation that all of the following are true:
(i) The production batch or harvest batch and sample have been correctly entered into the statewide monitoring system.
(ii) The tag for the sample is correctly associated with the tag for the harvest batch or production batch from which the sample was collected.
(iii) The tests to be performed on the sample are agreed on and verified by the marihuana business and laboratory.
(iv) If the sample is collected for a retest, the harvest batch or production batch from which the sample was collected is not ineligible for a retest.
(2) A laboratory employee and an employee from the marihuana business shall sign and date the chain of custody form.
(3) A laboratory employee shall place the sample in a secured container that is not accessible while in transit. The container must be secured by a locked closed lid or door, or sealed by a tamper-proof tape that indicates if the sample had been tampered with during transport.
(4) Before transporting a sample, a laboratory shall create a route plan and manifest. All of the following apply to the route plan and manifest:
(a) A laboratory employee shall follow the route plan when transporting marihuana.
(b) A laboratory employee shall only possess or transport marihuana that is included on the manifest.
(c) A laboratory employee shall carry a copy of the route plan and manifest while transporting marihuana.
(5) A laboratory shall not transport a sample of marihuana in a vehicle that bears markings that indicate that marihuana is being transported in the vehicle.
R. 420.305 Testing; laboratory requirements.
(2) A laboratory shall use
analytical testing methodologies for the required safety tests in subrule (3)
of this rule that are based upon published peer-reviewed
methods, have been validated for cannabis testing by an independent third
party, and have been internally verified by the licensed laboratory according
to Appendix J or K of Official Methods of Analysis
authored by the Association of Official Analytical Collaboration (AOAC)
International, with guidance from published cannabis standard method
performance requirements where available. In the absence of published, peer
reviewed, validated cannabis methods, method validation requirements of
Appendix J or K of Official Methods of Analysis authored by the Association of
Official Analytical Collaboration (AOAC) International must be met in full with
guidance from published cannabis standard method performance requirements where
available. The agency may monitor a laboratories analytical testing
methodologies on an ongoing basis.
(3) A laboratory shall
conduct the required safety tests specified in subdivisions (a) to (i) of this
subrule on marihuana product that is part of the harvest batch or production
batch as specified in R 420.303, except as provided in subrule (4) of this
rule. The minimum testing portions to be used in compliance testing shall be
consistent with the testing portions used during method validation. The agency
may publish a guide indicating which of the following safety tests are required
based on product type when the marihuana product has changed form:
(a) Potency analysis. All of the following apply to a potency analysis
under this subdivision:
(i) In the preparation of
samples intended for potency analysis, the laboratory may not adulterate or
attempt to manipulate the total potency of the sample by any means, including
by the addition of trichomes that were removed during the grinding and
homogenization process.
(ii) All flower material
used for potency testing must be representative of the product used by the end
consumer and homogenized in such a way that it is representative of the way a
consumer would be using the product. Kief must not be reintroduced to the
flower sample during the homogenization process, unless fully validated to
Appendix K of Official Methods of Analysis authored by the Association of
Official Analytical Collaboration (AOAC) International.
(iii) Potency analysis
performed just as the marihuana product is without any corrective factor taken
for moisture content that includes concentrations of the following:
(A) Total
tetrahydrocannabinol (THC), including reporting all cannabinoids that can be
tested for using a method that meets the requirements of subrule 2 of this
rule.
(B) Tetrahydrocannabinoic
acid (THC-A).
(C) Total cannabidiol
(CBD) including reporting all cannabinoids that can be tested for using a
method that meets the requirements of subrule 2 of this rule.
(D) Cannabidiolic acid
(CBD-A).
(E) Additional
cannabinoids, which may be tested with approval from the agency.
(b) Inspection for foreign
matter including powdery mildew, organic, and inorganic material.
(c) Microbial screening
including an optimized incubation period for all non-molecular automated
systems methods and all plating-based methods used to report quantitative total
yeast and mold results.
(d) Chemical residue
testing performed for the list of banned chemical residues and the required
LOQs published by the agency.
(e) Heavy metals testing as
required in this rule.
(f) Residual solvents for
production batches of marihuana infused products and edible marihuana products.
The agency shall publish a list of required residual solvents to be tested for
and their action limits.
(g) Water activity.
(h) Mycotoxin screening if
requested by the agency.
(i) Target analytes if
requested by the agency. The agency shall publish a list of required target
analytes to be tested for and their LOQs.
(4) All marihuana producers
may become certified to GMP by a body accredited under ISO 17065. This
accreditation may enable the licensee certain allowances with testing. The
agency will publish those allowances and information on how to obtain approval
for allowances. The standard used for certification for GMP must be American
National Standards Institute (ANSI) accredited or equivalent.
(5) All marihuana
cultivators may become certified to GACP-GMP by a body accredited under ISO
17065. This accreditation may enable the licensee certain allowances with
testing. The agency will publish these allowances and information on how to
obtain approval for allowances. The standard used for certification for
GACP-GMP must be World Health Organization and American Herbal Products
Association or equivalent.
(6) Except as otherwise
provided in R 420.306, if a sample collected pursuant to R 420.304 or provided
to a laboratory pursuant to these rules does not pass the required safety
tests, the marihuana business that provided the sample shall destroy the entire
batch from which the sample was taken and document the destruction of the
sample using the statewide monitoring system pursuant to the acts and these
rules within 90 calendar days.
(7) A laboratory shall
conduct residual solvent testing on batches of marihuana concentrates and
marihuana-infused products. The agency shall publish a list of required
residual solvents to be tested for and their action limits.
(8) A laboratory shall
maintain any marihuana samples for at least 30 calendar days after test
completion and destroy the resulting waste in accordance with R 420.209.
(9) Potency shall include
the following cannabinoid concentrations listed in subdivisions (a) to (f) of
this subrule, subject to subdivisions (g) and (h) of this subrule:
(a) Total THC
concentration.
(b) THC-A concentration.
M Σ THC + (0.877 x M
Σ THC-A) =Total THC
(d) Total CBD
concentration.
(e) CBD-A concentration.
(f) Total CBD. The
following calculation must be used for calculating Total CBD, where M is the
mass or mass fraction of CBD and CBD-A:
M total CBD = M CBD +
0.877 x M CBD-A.
(g) For marihuana and
marihuana concentrates, total THC and total CBD must be reported in percentages.
(h) For marihuana infused
products, potency must be reported as milligrams of Total THC and Total CBD per
gram.
(10) The agency shall
publish a list of action limits for the required safety tests in subrule (3) of
this rule, except for potency. A marihuana sample with a value that exceeds
the published action limit is a failed sample. A marihuana sample that is at
or below the action limit is a passing sample.
(11) For chemical residue
and target analyte testing, the agency shall publish a list of quantification
levels. Any result that exceeds the action limit is a failed sample.
(12) If a sample provided to
a laboratory pursuant to this rule and R 420.304 passes the safety tests
required under subrule (3) of this rule, the laboratory shall enter the
information in the statewide monitoring system of passed test results within 3
business days of test completion. Passed test results must be in the statewide
monitoring system for a batch to be released for immediate processing, packaging,
and labeling for transfer or sale in accordance with the acts and these
rules.
(13) A laboratory shall
enter the results into the statewide monitoring system and file with the agency
within 3 business days of test completion.
(14) All laboratories shall
participate in the proficiency testing program established by the agency. A
laboratory shall analyze proficiency test samples from any ISO 17043 accredited
vendor on an annual basis unless the agency requests additional testing. The
proficiency testing provider shall be accredited for all relevant tests
required by the agency and by an accreditation body recognized under the
International Laboratory Accreditation Cooperation (ILAC). All testing must
use the same procedures with the same number of replicates, standards, testing
analysts, and equipment as used for marihuana product testing. A laboratory
shall successfully analyze 1 set of proficiency testing samples for all
required analytes not less than annually. A laboratory shall have all proficiency
testing results submitted directly to the agency from the vendor for review.
All failed proficiency tests must include corrective action documentation and
must be repeated until the laboratory obtains an acceptable result for all
analytes proficiency test. Proficiency tests must be externally graded and
results must be reported numerically and not as pass or fail results for all
quantitative methods.
(15) The agency shall take
immediate disciplinary action against any laboratory that falsifies records or
does not comply with the provisions of this rule, including sanctions or fines,
or both.
(16) A laboratory shall not
do any of the following:
(a) Desiccate samples.
(b) Pre-test samples.
(c) Select the best or most
desirable material from a batch for testing. All sample increments must have
the same chances of being selected.
(d) Manipulate samples in
any way that would alter the sample integrity or homogeneity of the sample.
(17) A laboratory shall
comply with random compliance checks at the request of the agency. The agency
or its authorized agents may collect a random sample of a marihuana product
from a laboratory or designate another laboratory to collect a random sample of
a marihuana product in a secure manner to test that sample for compliance
pursuant to these rules.
(18) A laboratory may
perform terpene analysis on a marihuana product by a method approved by the
agency, and the method must be accredited on the same frequency as all required
safety tests.
(19) A laboratory shall
comply with investigations to ensure the health and safety of the public. At
the request of the agency, a laboratory may be requested to perform testing as
part of an investigation.
(20) The agency may request
mycotoxin testing. A marihuana sample with a value that exceeds the published
acceptable level is a failed sample. A marihuana sample that is below the
acceptable value is a passing sample.
(21) Marihuana-infused
products found to contain Salmonella spp. or Shiga toxin producing E. coli
(STEC) must be reported to the agency, in a separate written communication, at
the same time as the safety compliance test results are entered into the
statewide monitoring system. (1) A laboratory shall perform the tests
under this part of these rules using only testing methods that have been
approved under R 420.310.
(2) For each test performed on marihuana under this part of these rules, a laboratory shall do all of the following:
(a) Perform the test on a representative sample of marihuana.
(b) Homogenize not less than 50% of the sample.
(c) Report the results of the test in the statewide monitoring system and on a certificate of analysis. The results must include all of the following:
(i) An indication of whether the sample passed the test by indicating “pass” or “fail” as determined by the action limits in R 420.306a.
(ii) The quantities of the substance for which the test was performed in parts per million (ppm) to an accuracy of 3 decimal places, unless otherwise specified by the agency.
(iii) If analytes were detected below the analytical method limit of quantitation, the numerical limit of quantitation and indicate “<LOQ.”
(d) Maintain the sample on which a test was performed for not less than 30 days after the test was completed and dispose of the sample in accordance with the requirements in R 420.211.
(3) A laboratory shall not do any of the following:
(a) Adulterate or alter, or attempt to adulterate or alter, a sample of marihuana used to perform a test under this part of these rules.
(b) Falsify test results or other records.
(c) Manipulate equipment, materials, or processes used to perform tests in a way that causes a test result to be inaccurate.
(d) Desiccate samples.
(e) Perform a test without reporting the results in the statewide monitoring system.
(f) Manipulate samples in a way that would alter the sample integrity or homogeneity of the sample.
(g) Deviate from a testing method approved under R 420.310 when performing tests under this part of these rules.
R 420.305a Validations. Rescinded.
Rule 5a. (1) All
validations must be submitted to the agency for approval with an acceptable
proficiency test that meets the standards in R 420.305(14), where all required
analytes are shown to have passed.
(2) Laboratories shall use
microbial testing methodologies for the required safety tests in R 420.305 that
are sourced from published peer reviewed methods, have been validated for
cannabis testing by an independent third party, and have been internally
verified by the licensed laboratory according to Appendix J of Official Methods
of Analysis authored by the Association of Official Analytical Collaboration
(AOAC) International, with guidance from published cannabis standard method
performance requirements where available. In the absence of published, peer
reviewed, validated cannabis methods, Appendix J of Official Methods of
Analysis authored by the Association of Official Analytical Collaboration must
be met in full with guidance from the cannabis standard method performance
requirements where available. The agency shall approve the validated
methodology used by the laboratory and confirm that it produces scientifically
accurate results for each safety test it conducts. The agency may monitor a
laboratory’s microbial methodologies on an ongoing basis. All of the following
apply to validated methodologies under this rule:
(a) All validations must be
submitted to the agency for approval with an acceptable and graded external
proficiency test by a third party, where all required analytes are shown to
have passed.
(b) Validation protocols
should perform inoculation of marihuana matrices with live organisms where
feasible to ensure that both extraction and detection for the assay are
tested. To further test the accuracy of the assay, probability of detection
(POD) analyses, inclusivity, exclusivity, lot-to-lot stability, and robustness
studies must be included in the validation studies.
(c) Methods adopted from a
matrix specific standard method, inclusivity and exclusivity do not require a
comprehensive reassessment, provided that there were no modifications to the
methods, including, but not limited to, all of the following:
(i) Referenced media.
(ii) Primers.
(iii) Probes.
(iv) Antibodies.
(v) Critical chemistries
that were not modified.
(d) Microbial methods must
include environmental monitoring and quality control of all buffers, media,
primers, and incubators.
R 420.305b Quality assurance
and quality control. Rescinded.
Rule 5b. (1) A laboratory
must have a procedure for monitoring the validity of results.
(2) This monitoring must
occur on an ongoing basis and be reviewed by the laboratory manager. The
monitoring must include all of the following:
(a) Use of reference
materials or quality control materials.
(b) A functional check or
checks of measuring and testing equipment.
(c) Use of working
standards and verification with control charts, where applicable.
(d) Intermediate checks on
measuring equipment.
(e) Review of reported
results.
(f) Intra-laboratory
comparisons, which involve proficiency testing.
(3) A laboratory shall
adhere to all required quality control procedures specified in the reference
method or methods to ensure that routinely generated analytical data is
scientifically valid and defensible and is of known and acceptable precision
and accuracy.
(4) A laboratory shall have
a written quality assurance manual that includes, but is not limited to, all of
the following items:
(a) Laboratory organization
and responsibilities.
(c) Field sampling
procedures.
(d) Instrument and
equipment preventative maintenance and calibration procedures.
(e) Data reduction,
validation, reporting, and verification.
(f) Identification of
laboratory errors, customer complaints, and corrective actions.
(5) A laboratory shall
prepare a written description of its quality control activities, included as
part of a quality control manual. All of the following items must be addressed
in the quality control manual:
(a) Daily, weekly, monthly,
and annual requirements.
(b) An analytical testing
batch.
(c) All analytical testing
runs must be bracketed with quality controls.
(6) Method specific quality
control acceptance criteria, which must be followed.
(7) A laboratory shall have
standard operating procedures for all sampling and testing performed.
(8) All standard operating
procedures for the required safety tests in R 420.305 and for sampling and
testing of marihuana and marihuana products shall conform to ISO/IEC 17025:2017
standards, Good Laboratory Practice Standards 40 CFR 160, and shall be approved
by the agency prior to the performance of any safety tests.
(9) A laboratory shall
maintain a quality control and quality assurance program that conforms to Good
Laboratory Practice Standards 40 CFR 160 and ISO/IEC 17025:2017 standards and
meets the requirements established by the agency.
R 420.306 Testing marihuana
product after failed initial safety testing and remediation Required
tests.
Rule 6306. (1)
A laboratory may test marihuana product that has failed initial safety
testing.
(2) A failed marihuana
product must pass 2 separate tests with new samples consecutively to be
eligible to proceed to sale or transfer.
(3) Products that failed
testing for Aspergillus may be remediated after subsequent testing for
mycotoxins in accordance with R 420.305(3)(h).
(4) The agency may publish a
remediation protocol including, but not limited to, the sale or transfer of
marihuana product after a failed safety test as provided in these rules.
(5) The marihuana business
that provided the sample is responsible for all costs involved in a retest. (1)
A laboratory shall perform full compliance testing on samples of marihuana.
This subrule does not apply to research and development testing.
(2) The tests that a laboratory must perform on each type of marihuana under subrule (1) of this rule are indicated in table 1.
TABLE 1
|
Raw Plant Material |
Non-Solvent Concentratea |
Inhalable Concentrate (Solvent based) |
Vape Concentrate |
Inhalable Compound Concentrate Productsb |
Marihuana-Infused Product |
Vitamin E Acetate |
|
|
|
X |
|
|
Homogeneity |
|
|
|
|
|
X |
Potency Analysis |
X |
X |
X |
X |
X |
X |
Foreign Matter Testing |
X |
X |
|
|
X |
X |
Microbial Screen |
X |
X |
|
|
X |
X |
Water Activity |
X |
|
|
|
X |
Xc |
Heavy Metal Screen |
X |
X |
X |
X |
X |
X |
Residual Solvents |
|
|
X |
X |
X |
X |
Terpene Testing |
X |
|
|
|
|
|
Chemical Residue Analysis |
X |
X |
X |
X |
X |
X |
a Extraction using ice water, rosin press or dry ice.
b Moonrock, Caviar joint, infused pre-roll, tarantula etc.
c Not required for non-edible marijuana product or beverages.
(3) In addition to the tests required in subrule (1) of this rule, if a sample fails a microbial screen due to a level of aspergillus that exceeds the action limit in R 420.306a(3), the laboratory shall perform mycotoxin testing on the sample.
(4) If a laboratory is performing a retest on marihuana, the laboratory shall only perform the tests that the marihuana previously failed.
R 420.306a Action limits; limits of quantitation.
Rule 306a. (1) The residual solvents for which marihuana must be tested and the action limits for those residual solvents are listed in table 1.
TABLE 1
Solvent |
Chemical Abstract Service (CAS) Registry Number |
Action Limit for Inhalable Products (ppm) |
Action Limit for Non-inhalable Products (ppm) |
1,2-Dichloroethane |
107-06-2 |
2.00 |
5.00 |
Acetone |
67-64-1 |
750 |
5,000 |
Acetonitrile |
75-05-8 |
60.0 |
410 |
Benzene |
71-43-2 |
1.00 |
2.00 |
Butanes (all isomers)* |
106-97-8 |
800 |
5,000 |
Chloroform |
67-66-3 |
2.00 |
60.0 |
Ethanol |
64-17-5 |
1,000 |
5,000 |
Ethyl acetate |
141-78-6 |
400 |
5,000 |
Ethyl ether |
60-29-7 |
500 |
5,000 |
Ethylene oxide |
75-21-8 |
5.00 |
50.0 |
Heptane |
142-82-5 |
500 |
5,000 |
Hexanes (all isomers)^ |
110-54-3 |
50 |
290 |
Isopropyl alcohol |
67-63-0 |
500 |
5,000 |
Methanol |
67-56-1 |
250 |
3,000 |
Methylene chloride |
75-09-2 |
125 |
600 |
Pentanes (all isomers)+ |
109-66-0 |
750 |
5,000 |
Propane |
74-98-6 |
2,100 |
5,000 |
Trichloroethylene |
79-01-6 |
25.0 |
80.0 |
Toluene |
108-88-3 |
150 |
890 |
Total xylenes (ortho-, meta-, para-) |
1330-20-7 |
150 |
2,170 |
* Butane isomers include 2-methylpropane or isobutane CAS Number 75-28-5.
^ Hexane isomers 2,2-Dimethylbutane CAS Number: 75-83-2, 2,3-Dimethylbutane CAS Number: 79-29-8, 2-Methylpentane CAS Number: 107-83-5, 3-Methylpentane CAS Number: 96-14-0.
+ Pentane isomers include isopentane (methylbutane) CAS Number: 78-78-4 & neopentane (dimethylpropane) CAS Number: 463-82-1 Y.
(2) The heavy metals for which marihuana must be tested and the action limits for those heavy metals are listed in table 2. The limit of quantitation for heavy metals must be half of the action limit.
TABLE 2
Heavy Metal |
Action Limit for Inhalable Marijuana Flower (ppm) |
Action Limit for Inhalable Marijuana Concentrates (ppm) |
Action Limit for Non-inhalable Products (ppm) |
Lead |
1.00 |
0.500 |
0.500 |
Inorganic Arsenic |
0.400 |
0.200 |
1.500 |
Mercury |
0.200 |
0.100 |
3.000 |
Cadmium |
0.400 |
0.200 |
0.500 |
Total Chromium |
1.200 |
0.600 |
2.000 |
Nickel |
1.000 |
0.500 |
Not required |
Copper* |
Not Required |
3.000+ |
Not required |
* Copper is required for vaping products only.
(3) The microbials for which marihuana must be tested and the action limits for those microbials are listed in table 3.
TABLE 3
Microbial |
Bud, Shake/Trim, and Kief (CFU/g) |
Marijuana-Infused Product (CFU/g) |
Total Yeast and Mold Count (Medical Marihuana) |
10,000 |
10,000 |
Total Yeast and Mold Count (Adult-use Marihuana) |
100,000 |
10,000 |
Total Coliforms |
1,000 |
100 |
Shiga toxin-producing E. coli (STEC) |
Not detected in 10 grams |
Not detected in 10 grams |
Pathogenic Salmonella spp. |
Not detected in 10 grams |
Not detected in 10 grams |
Aspergillus flavus, fumigatus, niger & terreus |
Not detected in 10 grams |
Not detected in 10 grams |
(4) The banned chemicals for which marihuana must be tested and the action limits for those banned chemicals are listed in table 4.
TABLE 4
Banned chemical |
CAS Number |
Action Limit (ppm) |
LOQ (ppm) |
Abamectin |
71751-41-2 |
0.5 |
0.25 |
Acephate |
30560-19-1 |
0.4 |
0.2 |
Acequinocyl |
57960-19-7 |
2 |
1 |
Acetamiprid |
135410-20-7 |
0.2 |
0.1 |
Aldicarb |
116-06-3 |
0.4 |
0.2 |
Azoxystrobin |
131860-33-8 |
0.2 |
0.1 |
Bifenazate |
149877-41-8 |
0.2 |
0.1 |
Bifenthrin |
82657-04-3 |
0.2 |
0.1 |
Boscalid |
188425-85-6 |
0.4 |
0.2 |
Carbaryl |
63-25-2 |
0.2 |
0.1 |
Carbofuran |
1563-66-2 |
0.2 |
0.1 |
Chlorantraniliprole |
500008-45-7 |
0.2 |
0.1 |
Chlorfenapyr |
122453-73-0 |
1 |
0.5 |
Chlorpyrifos |
2921-88-2 |
0.2 |
0.1 |
Clofentezine |
74115-24-5 |
0.2 |
0.1 |
Cyfluthrin |
68359-37-5 |
1 |
0.5 |
Cypermethrin |
52315-07-8 |
1 |
0.5 |
Daminozide |
1596-84-5 |
1 |
0.5 |
DDVP (Dichlorvos) |
62-73-7 |
1 |
0.5 |
Diazinon |
333-41-5 |
0.2 |
0.1 |
Dimethoate |
60-51-5 |
0.2 |
0.1 |
Ethoprophos |
13194-48-4 |
0.2 |
0.1 |
Etofenprox |
80844-07-1 |
0.4 |
0.2 |
Etoxazole |
153233-91-1 |
0.2 |
0.1 |
Fenoxycarb |
72490-01-8 |
0.2 |
0.1 |
Fenpyroximate |
134098-61-6 |
0.4 |
0.2 |
Fipronil |
120068-37-3 |
0.4 |
0.2 |
Flonicamid |
158062-67-0 |
1 |
0.5 |
Fludioxonil |
131341-86-1 |
0.4 |
0.2 |
Hexythiazox |
78587-05-0 |
1 |
0.5 |
Imazalil |
35554-44-0 |
0.2 |
0.1 |
Imidacloprid |
138261-41-3 |
0.4 |
0.2 |
Kresoxim-methyl |
143390-89-0 |
0.4 |
0.2 |
Malathion |
121-75-5 |
0.2 |
0.1 |
Metalaxyl |
57837-19-1 |
0.2 |
0.1 |
Methiocarb |
2032-65-7 |
0.2 |
0.1 |
Methomyl |
16752-77-5 |
0.4 |
0.2 |
Methyl parathion |
298-00-0 |
0.2 |
0.1 |
MGK-264 |
113-48-4 |
0.2 |
0.1 |
Myclobutanil |
88671-89-0 |
0.2 |
0.1 |
Naled |
300-76-5 |
0.5 |
0.25 |
Oxamyl |
23135-22-0 |
1 |
0.5 |
Paclobutrazol |
76738-62-0 |
0.4 |
0.2 |
Permethrins* |
52645-53-1 |
0.2 |
0.1 |
Prallethrin |
23031-36-9 |
0.2 |
0.1 |
Phosmet |
732-11-6 |
0.2 |
0.1 |
Propiconazole |
60207-90-1 |
0.4 |
0.2 |
Propoxur |
114-26-1 |
0.2 |
0.1 |
Pyridaben |
96489-71-3 |
0.2 |
0.1 |
Pyrethrins+ |
8003-34-7 |
1 |
0.5 |
Spinosad |
168316-95-8 |
0.2 |
0.1 |
Spiromesifen |
283594-90-1 |
0.2 |
0.1 |
Spirotetramat |
203313-25-1 |
0.2 |
0.1 |
Spiroxamine |
118134-30-8 |
0.4 |
0.2 |
Tebuconazole |
80443-41-0 |
0.4 |
0.2 |
Thiacloprid |
111988-49-9 |
0.2 |
0.1 |
Thiamethoxam |
153719-23-4 |
0.2 |
0.1 |
Trifloxystrobin |
141517-21-7 |
0.2 |
0.1 |
* Permethrins should be measured as cumulative residue of cis- and trans-permethrin isomers (CAS numbers 54774-45-7 and 51877-74-8).
+ Pyrethrins should be measured as the cumulative residues of pyrethrin 1, cinerin 1 and jasmolin 1 (CAS numbers121-21-1, 25402-06-6, and 4466-14-2 respectively).
(5) The target analytes for which marihuana must be tested and the action limits for those analytes are listed in table 5.
TABLE 5
(CAS) Number |
Action Limit (ppm) |
LOQ (ppm) |
|
Vitamin E Acetate |
58-95-7 |
100 |
100 |
Squalene |
111-02-4 |
100 |
100 |
Squalane |
111-01-3 |
100 |
100 |
Medium Chain Triglycerides |
|||
Glycerol tricapronate (C6) |
621-70-5 |
100 |
100 |
Glycerol tricaprylate (C8) |
538-23-8 |
100 |
100 |
Glycerol tricaprate (C10) |
621-71-6 |
100 |
100 |
Glycerol trilaurate (C12) |
538-24-9 |
100 |
100 |
Propylene Glycol |
57-55-6 |
100 |
100 |
(6) The list of mycotoxins for which marihuana must be tested and the accepted detection limits for those mycotoxins are listed in table 6.
TABLE 6
Mycotoxin |
Detection Limit (ppb) |
Aflatoxin B1 |
<20 |
Aflatoxin B2 |
<20 |
Aflatoxin G1 |
<20 |
Aflatoxin G2 |
<20 |
Ochratoxin A |
<20 |
(7) The action limits for water activity (aw) are listed in table 7.
TABLE 7
Marihuana Product |
Action limit (aw) |
Marihuana other than an edible marihuana product |
.65 |
Edible marihuana product |
.85 |
(8) A test result with a value that exceeds the action limit is a failed test. A test result that is at or below the action limit is a passing sample.
R 420.306b Analysis for foreign matter.
Rule 306b. (1) A laboratory shall perform foreign matter testing before all other testing except microbial testing.
(2) Sample material remaining after foreign matter testing can be used for all other chemical testing except microbial testing.
(3) A laboratory shall perform foreign matter testing on not less than 30% of the representative sample, either by weight in grams or of the total lot, of intact buds and flower material before grinding or milling the sample. In the case of marihuana flower, the 30% must come from separate, intact buds.
(4) All of the following apply to foreign matter analysis:
(a) The buds must be separated into not less than 10 increments. The results from the test of each increment may be averaged together to determine the total foreign matter contamination.
(b) Dissection of nodes must be done whenever physically possible. If the dissection of distinct nodes is deemed impractical due to the small and compact nature of the buds, commonly known as popcorn buds, the buds must be examined in their entirety and additionally cut in half to observe the inside of the buds.
(c) When testing marihuana trim, kief, marihuana concentrate, or a marihuana-infused product, the calculation used by the laboratory to determine 30% of the sample must be included in the standard operating procedure for performing the test.
(d) Quantitation of foreign matter must be done as a total surface area calculation. The calculation used by the laboratory to determine quantified filth must be included in the standard operating procedure for performing the test.
(5) If a sample fails a test for foreign matter, the laboratory shall include a note in the statewide monitoring system and on the certificate of analysis listing all contaminants identified in the sample.
(6) A laboratory that performs foreign matter testing shall do all of the following:
(a) Develop a procedure and associated training documents for the identification of powdery mildew, pests, mold and other foreign material that requires agency approval before testing. The training document must include a reference text for common cannabis contaminants.
(b) Examine both the exterior and interior of the sample on both high-power magnification of not less than 100x and low power magnification of between 30x and 40x.
(c) Dissect the material while viewing under a microscope.
(d) Perform all quantitation on high power magnification.
(e) Develop a qualitative grading scale to report test results. The qualitative grading scale must clearly indicate which qualification or qualifications indicate a failed test result.
(f) Document all failure photographically.
(7) The action limit for crude marijuana is not more than 5% of stems and not more than 2% of other foreign matter.
(8) For purposes of foreign matter testing, inorganic matter includes material that would not normally be found on a living organism, including, but not limited to, any of the following:
(a) Glass.
(b) Metal shavings.
(c) Synthetic fibers.
(9) The presence of inorganic matter on a marihuana plant, marihuana concentrate, or a marihuana-infused product results in a failure of the foreign matter test.
R 420.306c Homogeneity testing.
Rule 306c. (1) Each dose or serving must be tested as a separate sample.
(2) Not less than 10 doses, servings, or increments must be sampled and tested at random.
(3) The weight of the sample and concentration of each cannabinoid must be recorded in the test results.
(4) A sample has passed homogeneity testing only if it meets both of the following:
(b) The concentration of each of the following cannabinoids in a serving does not vary by more than 15% from the concentration of that cannabinoid in another serving included in a single package:
(i) Total THC.
(ii) Tetrahydrocannabinolic acid (THC-A).
(iii) Total CBD.
(iv) Cannabidiolic acid (CBD-A).
(5) The variation of the weight and concentration of a cannabinoid in a single package must be determined by first calculating the standard deviation among samples and then calculating the relative standard deviation for weight of the serving and concentration of the cannabinoid.
(6) The standard deviation of weight and concentration of a cannabinoid can be calculated using the following formula, where SD is standard deviation:
(7) The relative standard deviation is calculated using the following formula, where SD means standard deviation and RSD means relative standard deviation:
R 420.306d Potency analysis.
Rule 306d. (1) All of the following apply to a potency analysis required in R 420.306:
(a) A laboratory shall not adulterate or attempt to manipulate the total potency of a sample by any means, including by the addition of trichomes that were removed during the grinding and homogenization process.
(b) A sample must be tested as collected without introducing substances or materials that were not a part of the original sample and without reintroducing a material that may have originally been a part of the representative sample, but has for any reason been separated from the representative sample in such a way that would result in non-homogeneity to a part of the test batch.
(c) Marihuana used for potency testing must be representative of the marihuana used by the consumer and homogenous with the remainder of the harvest batch or production batch.
(d) A laboratory shall not reintroduce kief into a sample of flower during the homogenization process, unless the method of reintroduction, homogenization, and sample preparation has been validated to Appendix K of Official Methods of Analysis authored by the Association of Official Analytical Collaboration (AOAC) International and the laboratory demonstrates that the addition of kief to the sample does not alter sample homogeneity in any way when compared to the test sample.
(2) Potency includes the concentrations of the following cannabinoids:
(a) Total THC.
(b) THC-A.
(c) Total CBD.
(d) CBD-A.
(3) The following calculation must be used for calculating total THC, where Σ is the sum and M is the mass or mass fraction of each THC isomer being reported or THC-A:
M Σ THC + (0.877 x M Σ THC-A) =Total THC.
(4) The following calculation must be used for calculating total CBD, where M is the mass or mass fraction of CBD and CBD-A: M total CBD = M CBD + 0.877 x M CBD-A.
(5) For marihuana flower and marihuana concentrates, total THC and total CBD must be reported in percentages.
(6) For marihuana-infused products, potency must be reported as milligrams of total THC and total CBD per gram.
(7) A laboratory shall establish a limit of quantitation of 1.0 milligrams per gram (mg/g) or lower for all required cannabinoids analyzed and reported.
(8) A cultivator or producer shall inform the laboratory of the serving and dosage size for the marihuana product from which the sample was collected. The laboratory shall use the information provided by the cultivator or producer at the time the sample was collected. If a product is sampled as an individual serving or dosage, the cultivator or producer shall report total THC by serving or dose. Potency must be reported as a percent and by weight in milligrams of THC.
R 420.306e Minimum test portions.
Rule 306e. (1) A laboratory shall test a sample size that is not less than the following:
(a) For a test to determine the cannabinoid profile, .5 grams.
(b) For all tests to determine microbial contamination, 10 grams per test for all of the following:
(i) Total yeast and mold.
(ii) Total coliforms.
(iii) Aspergillus.
(iv) Salmonella.
(v) STEC.
(c) For a test to assess the presence of residual solvents, .25 grams.
(d) For a test to assess the presence of heavy metals, .5 grams.
(e) For a test to determine the presence of foreign material, 30% of the total representative sample of intact buds and flower material before grinding or milling.
(f) For an analysis of chemical residues, .5 grams.
(g) For an analysis of mycotoxins, .5 grams.
R 420.307 Research and
development testing Beverage testing and analysis.
Rule 7307. (1)
As used in this rule, “research and development testing” means optional testing
performed before final compliance testing.
(2) Except for R
420.304(2)(b), when performing research and development testing, the laboratory
must comply with these rules.
(3) Punitive action shall not
be taken against a marihuana business for conducting research and development
testing when permitted.
(4) The agency may publish
guidance for research and development testing that must be followed by all
marihuana businesses.
(5) All research and
development testing must be entered into the statewide monitoring system.
(6) Research and development
testing performed after compliance testing has been completed shall not replace
safety compliance test results. (1) A laboratory shall do all of the
following before performing tests on marihuana-infused beverages:
(a) Obtain an expanded scope of accreditation from their accrediting body.
(b) Submit a testing method for testing marihuana-infused beverages, including a currently approved method that is being expanded for testing marihuana-infused beverages to the agency for approval. The laboratory shall not use the testing method to test marihuana-infused beverages until it is approved by the agency.
(c) Perform matrix specific verification or validation, whichever is more appropriate, for all analyses.
(d) Submit to the agency proof of a passing proficiency test. The proficiency test must be performed on a beverage-specific matrix if a matrix is available.
(e) Determine, in consultation with the producer of the marihuana-infused beverage, steps that are necessary to optimize extractions for all analyses and required testing based on the processes used in the creation of the marihuana-infused beverage.
(2) A testing method used to test marihuana-infused beverages must meet the requirements of R 420.310.
(3) A laboratory that has partnered with a producer to develop a marihuana-infused beverage shall perform the tests required in R 420.306.
(4) A marihuana-infused beverage in final form must undergo all safety testing required of a marihuana-infused product in R 420.306. In addition to the safety tests in R 420.306, a marihuana-infused beverage is subject to the following tests:
(a) pH testing. A laboratory performing a pH test shall follow AOAC Method 945.10 and perform analyses and validations in accordance with manufacturer specifications.
(b) Terpene testing. A laboratory shall perform terpene testing using a method that is appropriately validated or use a method that is developed by the laboratory and meets the requirements of R 420.310. A laboratory shall test for all of the following terpenes:
(i) Alpha-bisabol.
(ii) Alpha-humulene.
(iii) Alpha-pinene.
(iv) Alpha-terpinene.
(v) Beta-caryophyllene.
(vi) Beta-myrcene.
(vii) Beta-pinene.
(viii) Caryophyllene oxide.
(ix) Eucalyptol.
(x) Limonene.
(xi) Linalool.
(xii) Nerolidol.
(xiii) Phytol.
R 420.308 Severability Retesting
marihuana after failed initial safety testing.
Rule 8308. If
any rule or subrule of these rules, in whole or in part, is found to be invalid
by a court of competent jurisdiction, such decision will not affect the
validity of the remaining portion of these rules. (1) A laboratory may
retest marihuana that has failed initial safety testing.
(2) If marihuana fails safety testing, the marihuana business that cultivated or processed the marihuana may do 1 or more of the following:
(a) Have the marihuana retested. Both of the following apply to retesting:
(i) A marihuana business shall not sell, transfer, or remove from quarantine the harvest batch or production batch of marihuana until the marihuana has passed 2 separate consecutive retests with new samples for each test.
(ii) Marihuana that fails testing can be retested 2 additional times. Marihuana that has failed 3 tests must be disposed of.
(b) Remediate the marihuana under R 420.309.
(c) Dispose of the marihuana.
R 420.309 Remediation.
Rule 309. (1) All of the following apply to remediation:
(a) A licensee shall submit a request to the agency to remediate marihuana that failed safety testing and receive approval from the agency before remediating the marihuana.
(b) Marihuana that has been remediated must pass 2 separate consecutive retests with new samples for each test before the batch of the marihuana from which the sample was collected can be removed from quarantine and transferred or sold.
(c) Marihuana flower that is remediated must be tested for potency before the harvest batch from which the sample was collected can be removed from quarantine and transferred or sold.
(d) An extracted marihuana product that is remediated must pass tests for residual solvents before the production batch from which the sample was collected can be removed from quarantine and transferred or sold.
(e) Marihuana that failed testing for aspergillus must be tested for mycotoxins before being remediated.
(f) Marihuana in the possession of a cultivator that failed safety testing may be sent to a producer for remediation using only extraction.
(g) Marihuana that fails testing may be remediated and retested until it passes testing.
(2) A marihuana business may not remediate or, except as provided in subrule (3) of this rule, retest marihuana that fails for any of the following:
(a) Chemical residue.
(b) E. coli.
(c) If the marihuana is a vape cart, vitamin E.
(d) If the marihuana is marihuana concentrate, mycotoxins.
(e) Squalene.
(f) Squalane.
(g) Vitamin E Acetate.
(h) Triglycerides, including, but not limited to, medium-chain triglyceride (MCT) oil.
(i) Propylene glycol, unless the marihuana is delivered through a metered dose inhaler, the functionality of which does not require combustion or heated vaporization.
(3) A marihuana business may retest marihuana that failed a test under subrule (2) of this rule to confirm the initial test result. A marihuana business shall not remediate the marihuana before retesting and shall request and receive approval from the agency before retesting.
(4) A marihuana business shall dispose of the harvest batch or production batch of marihuana from which the samples that failed testing in subrule (2) of this rule were taken.
(5) If a sample of marihuana fails testing, a marihuana business shall not combine the harvest batch or production batch of marihuana from which the sample was taken with marihuana from any other harvest batch or production batch.
(6) The marihuana business that provided the sample is responsible for all costs involved in a retest.
R 420.310 Method validations.
Rule 310. (1) A laboratory shall submit a testing method to the agency for approval. The laboratory shall not use the testing method to perform tests under this part of these rules until the testing method is approved by the agency.
(2) Except as provided in subrules (3) and (5) of this rule, a laboratory shall use a testing method found in Official Methods of Analysis, published by the Association of Official Analytical Collaboration (AOAC) for all tests required under this part.
(3) If a microbial testing method does not exist that meets the requirements of subrule (2) of this rule, a laboratory shall use a microbial testing method that meets all of the following requirements:
(a) The method is sourced from published peer reviewed methods.
(b) The method has been validated for cannabis testing by an independent third party.
(c) The method has been internally verified by the licensed laboratory according to Appendix J of Official Methods of Analysis authored by the Association of Official Analytical Collaboration (AOAC) International, with guidance from published cannabis standard method performance requirements where available.
(4) All of the following apply to a validated microbial testing method:
(a) A laboratory shall submit a validation to the agency with an acceptable and graded external proficiency test conducted by a third party in which all required analytes are shown to have passed.
(b) Validation protocols must include the inoculation of marihuana matrices with live organisms, if feasible, to ensure that both extraction and detection for the assay are tested. The validation study must also include probability of detection analysis, inclusivity, exclusivity, lot-to-lot stability, and robustness studies.
(c) If a testing method is adopted from a matrix specific standard method, inclusivity and exclusivity do not require a comprehensive reassessment if no modifications were made to the methods, including, but not limited to, any of the following:
(i) Reference media.
(ii) Primers.
(iii) Probes.
(iv) Antibodies.
(v) Critical chemistries that were not modified.
(d) The method must include environmental monitoring and quality control of all buffers, media, primers, and incubators.
(5) If an analytical testing method does not exist that meets the requirements of subrule (2) of this rule, a laboratory shall validate an analytical testing method that meets the requirements of Appendix K of Official Methods of Analysis published by the Association of Official Analytical Collaboration with guidance from the cannabis standard method performance requirements where available.
(6) When submitting an analytical testing method for approval, a laboratory shall submit all of the following for the method:
(a) Accuracy.
(b) Repeatability precision.
(c) Reproducibility precision.
(d) Analytical sensitivity.
(e) Instrument limit of detection.
(f) Instrument limit of quantitation.
(g) Reportable range.
(h) The presence or effect of interfering substances.
(7) The agency shall monitor a laboratory’s testing methods on an ongoing basis and may rescind its approval of a method if it determines that the laboratory is producing inaccurate or imprecise results by using the method.
R 420.311 Quality assurance and quality control.
Rule 311. (1) A laboratory shall have a procedure for monitoring the validity of results.
(2) This monitoring procedure must occur on an ongoing basis and be reviewed by the laboratory manager. The monitoring must include all of the following:
(a) Use of reference materials or quality control materials.
(b) A functional check or checks of measuring and testing equipment.
(c) Use of working standards and verification with control charts, where applicable.
(d) Intermediate checks on measuring equipment.
(e) Review of reported results.
(f) Review of reagent logs.
(g) Intra-laboratory comparisons, which involve proficiency testing.
(3) A laboratory shall adhere to all required quality control procedures specified in the reference method or methods to ensure that routinely generated analytical data is scientifically valid and defensible and is of known and acceptable precision and accuracy.
(4) A laboratory shall have a written quality assurance manual that includes, but is not limited to, all of the following items:
(a) Laboratory organization and responsibilities.
(b) Field sampling procedures.
(c) Instrument and equipment preventative maintenance and calibration procedures.
(d) Data reduction, validation, reporting, and verification.
(e) Identification of laboratory errors, customer complaints, and corrective actions.
(f) Procedures for the verification of instruments and software.
(g) Proof of reliability testing of reagents performed before or concurrent to their use in the testing required under part 5 of these rules.
(5) A laboratory shall prepare a written description of its quality control activities in a quality control manual. All of the following items must be addressed in the quality control manual:
(a) Daily, weekly, monthly, and annual requirements.
(b) An analytical testing batch.
(c) All analytical testing runs must be bracketed with quality controls.
(d) Method specific quality control acceptance criteria that must be followed.
(6) All standard operating procedures for the required safety tests in R 420.306 and for sampling and testing of marihuana must conform to ISO/IEC 17025:2017 standards and Good Laboratory Practice Standards 40 CFR 160 and be approved by the agency before the performance of the safety tests.
(7) A laboratory shall maintain a quality control and quality assurance program that conforms to Good Laboratory Practice Standards 40 CFR 160 and ISO/IEC 17025:2017 standards and meets the requirements established by the agency.
(8) A laboratory shall perform calibration by preparing a series of standard solutions from a reference material, by dilution of a stock solution, covering a reasonable range of signal response from the instrument. A laboratory shall use 4 or more points, approximately equally spaced over the concentration range of interest, performed in duplicate but measured at random to avoid confusing nonlinearity with drift. The laboratory shall fit the calibration line and plot the residuals as a function of the concentration. The calibration line must produce a random pattern of residuals with a zero mean.
(9) A laboratory shall annually demonstrate the capability to accurately measure the method detection limit for each analyte for which the lab will perform testing. The laboratory shall demonstrate this by performing tests on not less than 7 samples at low levels following the procedure established in appendix B to 40 CFR Part 136, for each analyte.
(10) A laboratory employee who performs a test required under this part shall annually, or at the request of the agency, demonstrate their capability to perform the test. A demonstration of capability must include all of the following:
(a) Documentation verifying that the employee is capable of accurately performing the test.
(b) Documentation verifying that the employee has read and understands all applicable standard operating procedures and methods.
(c) Successful completion of a competency assessment that includes performing tests of a previously tested sample from preparation of the sample to reporting the results.
(d) Documentation verifying successful completion of the competency assessment.
R 420.311a Quality control acceptance.
Rule 311a. (1) A laboratory shall create and maintain standard operating procedures for each testing method. The standard operating procedures must include, at minimum, both of the following:
(a) The acceptance ranges for standards, duplicates, and spikes.
(b) A plan of correction that indicates what a laboratory will do if quality control tests fail or are out of range.
(2) A laboratory shall verify that the acceptance ranges required under subrule (1) of this rule match the requirements of the testing method.
(3) An acceptance range required in subrule (1) of this rule must meet all of the following:
(a) The laboratory reagent blank must be less than the method detection limit.
(b) The initial calibration verification must not vary by more than 10% from a continuing calibration verification.
(c) The laboratory fortified matrix must not vary by more than 10% from the laboratory fortified matrix duplicate.
(d) The relative percent difference must be less than 20%.
(e) The reporting limit must equal the method of detection limit.
(f) The percent recovery for LFB must equal the LFB result multiplied by 100, divided by the expected concentration.
(g) The relative percent difference must be calculated using the following formula, where Num1 means the original number and Num2 means the second number:
Relative percent difference = (|Num1-Num2| / ((Num1+Num2) / 2)) x 100
(h) The percent recovery for the laboratory fortified matrix must equal the difference between laboratory fortified matrix result and the sample result, multiplied by 100.
R 420.312 Research and development testing.
Rule 312. (1) As used in this rule, “research and development testing” means optional testing performed before full compliance testing.
(2) Except for the sample size requirements in R 420.303, a laboratory shall perform research and development testing in compliance with the requirements of this part of these rules.
(3) Research and development testing performed after compliance testing is completed must not replace safety compliance test results.
R 420.313 Proficiency testing.
Rule 313. (1) A laboratory shall participate in the proficiency testing program established by the agency, which may include, but is not limited to, all of the following:
(a) Annual proficiency testing conducted by a recognized testing provider that is accredited for all tests required under this part of these rules by an accreditation body recognized under the International Laboratory Accreditation Cooperation (ILAC).
(b) Participation in proficiency testing events organized by the agency.
(c) Participation in round-robin testing directed by the agency.
(d) Participation in investigative testing.
(2) The annual proficiency testing in subrule (1)(a) of this rule must include of all of the following:
(a) Analyzing proficiency test samples from an ISO 17043 accredited testing provider.
(b) Performing tests using the same procedures with the same number of replicates, standards, employees, and equipment used for marihuana testing under this part of these rules.
(c) Analyzing 1 set of proficiency testing samples for all required analytes.
(3) The testing provider shall determine whether a laboratory passes the annual proficiency testing under subrule (1)(a) of this rule and submits the results of the proficiency testing to the agency.
(4) If a laboratory fails proficiency testing for an analyte for which testing is required under this part of these rules, the laboratory shall not perform tests for that analyte until the laboratory demonstrates to the agency that the laboratory can successfully perform the test.
(5) A laboratory that fails proficiency testing shall do both of the following:
(a) Submit a corrective action plan within 3 days after receiving notification from the testing provider that the laboratory failed the proficiency testing.
(b) Repeat the proficiency testing until the laboratory passes the proficiency testing.
(6) Proficiency testing must be externally graded, and the results must be reported numerically, not as pass or fail, for all quantitative methods.
R 420.314 Agency compliance testing.
Rule 314. The agency may do either of the following:
(a) Collect a sample of marihuana from a marihuana business or designate a laboratory to collect a sample of marihuana from a marihuana business to test that sample for compliance.
(b) Conduct audits of a laboratory’s operations, sample collection practices, testing methods, records, or other processes, procedures, or policies necessary to ensure a laboratory’s compliance with the acts and these rules.
DEPARTMENT OF
LICENSING AND REGULATORY AFFAIRS
MARIJUANA
REGULATORY AGENCY
MARIHUANA-INFUSED
PRODUCTS AND EDIBLE MARIHUANA PRODUCT PART 6. MARIHUANA PRODUCTS
(By authority conferred on the
executive director of the marijuana regulatory agency by section 206 of the
medical marihuana facilities licensing act, 2016 PA 281, MCL 333.27206,
sections 7 and 8 of the Michigan Regulation and Taxation of Marihuana Act, 2018
IL 1, MCL 333.27957 and 333.27958, and Executive Reorganization Order No.
2019-2, MCL 333.27001)
R 420.401 Definitions Marihuana
pre-rolls.
Rule 1401. (1)
As used in these rules:
(a) “Acts” refers to the
medical marihuana facilities licensing act, 2016 PA 281, MCL 333.27101 to
333.27801, and the Michigan Regulation and Taxation of Marihuana Act, 2018 IL
1, MCL 333.27951 to 333.27967, when applicable.
(b) “Agency” means the
marijuana regulatory agency.
(c) “Edible marihuana
product” means any marihuana-infused product containing marihuana that is
intended for human consumption in a manner other than inhalation. Edible
marijuana product does not include marihuana-infused products that are intended
for topical application.
(d) "Employee"
means a person performing work or service for compensation. “Employee” does not
include individuals providing trade or professional services who are not
normally engaged in the operation of a marihuana establishment.
(e) “Final form” means the
form a marihuana product is in when it is available for sale by a marihuana
sales location not including consumer packaging. For marihuana products
intended for inhalation, final form means the marihuana concentrate in an
e-cigarette or a vaping device.
(f) “Inactive ingredients”
means binding materials, dyes, preservatives, flavoring agents, and any other
ingredient that is not derived from the plant Cannabis sativa L.
(g) “Marihuana product”
means marihuana or a marihuana-infused product, or both, as those terms are
defined in the acts unless otherwise provided for in these rules.
(h) “Marihuana sales
location” refers to a provisioning center under the medical marihuana
facilities licensing act or a marihuana retailer under the Michigan Regulation
and Taxation of Marihuana Act, or both.
(i) “Marihuana tracking
act” means the marihuana tracking act, 2016 PA 282, MCL 333.27901 to 333.27904.
(j) “Medical marihuana
facilities licensing act” or “MMFLA” means the medical marihuana facilities
licensing act, 2016 PA 281, MCL 333.27101 to 333.27801.
(l) “Producer” refers to
both a processor under the medical marihuana facilities licensing act and a
marihuana processor under the Michigan Regulation and Taxation of Marihuana
Act.
(m) “Records of
formulation” means the documentation that includes at a minimum: the ingredients,
recipe, processing in order to be shelf stable, Certificates of Analysis for
any ingredient used, and description of the process in which all ingredients
are combined to produce a final package.
(n) “These rules” means the
administrative rules promulgated by the agency under the authority of the
medical marihuana facilities licensing act, the marihuana tracking act, the
Michigan Regulation and Taxation of Marihuana Act, and Executive Reorganization
Order No. 2019-2, MCL 333.27001.
(o) “Tag” or “RFID tag”
means the unique identification number or Radio Frequency Identification (RFID)
issued to a licensee by the statewide monitoring system for tracking,
identifying, and verifying marihuana plants, marihuana products, and packages
of marihuana product in the statewide monitoring system.
(2) Terms defined in the
acts have the same meanings when used in these rules unless otherwise
indicated. (1) A cultivator, producer, or marihuana sales location may
create a marihuana pre-roll.
(2) A producer creating a marihuana pre-roll may also do either of the following:
(a) Infuse the bud, shake, trim, or rolling paper with marihuana concentrate.
(b) Seal the marihuana pre-roll with an adhesive that is marihuana concentrate.
(3) A marihuana business shall not create a marihuana pre-roll unless all marihuana used to create the marihuana pre-roll has passed safety compliance testing required under part 5 of these rules.
(4) A marihuana pre-roll must not contain marihuana from more than 1 harvest batch. This subrule does not apply to marihuana concentrate that is infused or added to a pre-roll under subrule (2) of this rule.
(5) A final package with multiple marihuana pre-rolls may include pre-rolls with marihuana from different harvest batches provided that each pre-roll does not contain marihuana from more than 1 harvest batch.
(6) Unless specifically required by the agency, a marihuana pre-roll that meets the requirements of subrule (3) of this rule is not required to pass additional testing.
(7) A licensee shall not create a marihuana pre-roll unless the requirements of this rule are met.
R 420.402 Adoption by
reference Marihuana-infused products.
Rule 2402. (1)
The following codes, standards, or regulations of nationally recognized
organizations or associations are adopted by reference in these rules:
(a) National fire protection
association (NFPA) standard 1, 2021 edition, entitled “Fire Code,” is adopted
by reference as part of these rules. Copies of the adopted provisions are
available for inspection and distribution from the National Fire Protection
Association, 1 Batterymarch Park, P.O. Box 9101, Quincy, Massachusetts, 02169,
telephone number 1-800-344-3555, for the price of $114.50.
(b) The International
Organization for Standardization (ISO), ISO 22000 / ISO/TS 22002-1:2009, Food
Safety Bundle, available for purchase at:
https://webstore.ansi.org/Standards/ISO/ISO22000TS22002FoodSafety,
for the price of $275.00.
(c) International
Organization for Standardization (ISO), ISO/IEC 17025:2017, General
Requirements for the Competence of Testing and Calibration Laboratories,
available at: https://webstore.ansi.org/RecordDetail.aspx?sku=ISO%2fIEC+17025%3a2017,
for the price of $162.00.
(2) The standards adopted in
subrule (1)(a) to (c) of this rule are available for inspection and
distribution at the agency, located at 2407 North Grand River Avenue, Lansing,
Michigan, 48906. Copies of these standards may be obtained from the agency at
the cost indicated in subrule (1)(a) to (c) of this rule, plus shipping and
handling. (1) A marihuana-infused product must be homogenous.
(2) When creating an inhalable compound concentrate, all marihuana ingredients used to create the inhalable compound concentrate must pass full compliance testing before the creation of the inhalable compound concentrate.
(3) Inactive ingredients, other than botanically derived flavonoids, terpenoids, and terpenes that are chemically identical to the terpenes derived from the plant Cannabis sativa L., must be approved by the United States Food and Drug Administration (FDA) for the intended use, and the concentration must be less than the maximum concentration listed in the FDA inactive ingredient database for the intended use.
(4) All ingredients containing cannabinoids that are added to marihuana must be from a source licensed to grow, handle, and produce cannabinoids under a license issued by this state or another state and entered into the statewide monitoring system.
R 420.402a Edible marihuana products.
Rule 402a. (1) An edible marihuana product must be shelf stable.
(2) An edible marihuana product must have an expiration date. When determining an expiration date, a producer shall consider all of the following:
(a) The quality and characteristics of the edible marihuana product.
(b) The packaging of the edible marihuana product.
(c) The customary conditions encountered by the edible marihuana product from product to sale.
(3) An edible marihuana product must meet 1 of the following requirements:
(a) If the edible marihuana product is a solid item that consists of multiple servings, meet either of the following requirements:
(i) The product must be scored in a way that divides the product into easily observable single-serving portions and assists a marihuana customer in breaking the product into single-serving portions.
(ii) The final package must include a diagram that clearly indicates how the product must be cut or divided to obtain a single serving of the product.
(b) If the final package contains multiple servings of marihuana, 1 of the following:
(i) The edible marihuana product must be sold with a measuring device that allows a marihuana customer to dispense and measure single-serving portions. The measuring device must hold only 1 serving or be clearly marked to indicate the level of a single serving.
(ii) A single serving must be a single unit of the edible marihuana product.
(c) The edible marihuana product must be sold in a single-serving final package.
(4) An edible marihuana product may be a basic geometric shape, fruit flavored, or both.
R 420.402b Edible marihuana products; prohibitions.
Rule 402b. (1) An edible marihuana product must not be either of the following:
(a) Associated with cartoons, caricatures, toys, or designs that would appeal to minors.
(b) In the distinct shape of a human, animal, or fruit, or a shape that bears the likeness or contains characteristics of a realistic or fictional human, animal, or fruit, including artistic, caricature, or cartoon renderings.
(2) An edible marihuana product must not require time and temperature control for safety.
R 420.403 Requirements and
restrictions on marihuana-infused products; edible marihuana product Marihuana-infused
beverages.
Rule 3403. (1)
A producer shall package and properly label marihuana-infused products before
sale or transfer.
(2) Marihuana-infused
products processed under these rules must be homogenous. The allowable
variation for weight and THC and CBD concentrations between the actual results
and the intended serving is to be + or – 15%. The agency shall publish
guidelines for a producer to follow to verify the marihuana-infused product is
homogeneous.
(3) A producer of
marihuana-infused products shall list and record the THC concentration and CBD
concentration of marihuana-infused products, as provided in R 420.305 and R
420.404, in the statewide monitoring system and indicate the THC concentration
and CBD concentration on the label along with the tag identification as
required under these rules.
(4) Marihuana-infused
products that are part of a product recall are subject to all of the following
requirements:
(a) Must be immediately
pulled from production by the producer of the marihuana-infused product.
(b) Must be immediately
removed from the sales area of a marihuana sales location.
(c) Must not be sold or
transferred.
(5) Marihuana-infused
products must be stored and secured as prescribed under these rules.
(6) All non-marihuana
inactive ingredients must be clearly listed on the product label. Inactive
ingredients must be approved by the FDA for the intended use, and the
concentration must be less than the maximum concentration listed in the FDA
Inactive Ingredient database for the intended use.
(7) A producer shall label
all marihuana-infused product with all of the following:
(a) The name of the
marihuana-infused product that includes a product modifier such as “marijuana
product,” “THC product,” or “cannabis product” using the same or larger font
than the product name.
(b) The ingredients,
including excipients and diluents, of the marihuana-infused product, in
descending order of predominance by weight.
(c) The net weight or net
volume of the product.
(d) For an edible marihuana
product, both of the following must be included:
(i) Allergen labeling as
specified by the Food and Drug Administration (FDA), Food Allergen Labeling and
Consumer Protection Act of 2004 (FALCPA), 21 USC 343.
(e) The date the marihuana
product was produced.
(8) A producer of edible
marihuana product shall comply with all the following:
(a) Current Good
Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls
for Human Food, 21 CFR part 117. Any potentially hazardous ingredients used to
process shelf-stable edible marihuana products must be stored at 40 degrees
Fahrenheit, 4.4 degrees Celsius, or below.
(b) Maintain and adhere to
records of formulation and make them available to the agency upon request.
These records at a minimum must include the recipe, any additional processing
documentation that demonstrates the product to be shelf stable, and test
results for all ingredients used.
(c) Provide annual employee
training for all employees on safe food handling and demonstrate an employee’s
completion of this training by providing proof of food handler certification
that includes documentation of employee food handler training, including, but
not limited to, allergens and proper sanitation and safe food handling
techniques. Any course taken pursuant to this rule must be conducted for not
less than 2 hours and cover all of the following subjects:
(i) Causes of foodborne
illness, highly susceptible populations, and worker illness.
(ii) Personal hygiene and
food handling practices.
(iii) Approved sources of
food.
(iv) Potentially hazardous
foods and food temperatures.
(v) Sanitization and
chemical use.
(vi) Emergency procedures,
including, but not limited to, fire, flood, and sewer backup.
(d) Have an employee on
site during the production of edible marijuana products who is certified as a
Food Protection Manager.
(e) To ensure compliance
with the safe preparation standards under this subrule, comply with 1 or more
of the following:
(i) Current Good
Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls
for Human Food, 21 CFR part 117.
(ii) The International
Organization for Standardization (ISO), ISO 22000/ISO/TS 22002-1 adopted by
reference pursuant to R 420.402.
(f) If requested as
provided in this subdivision, provide to the agency documentation to verify
certifications and compliance with these rules. The agency may request in
writing documentation to verify certifications and compliance with these rules.
(9) A producer of edible
marihuana product may not:
(a) Produce an edible
marihuana product in a shape or with a label that would appeal to minors aged
17 years or younger.
(b) Produce an edible
marihuana product that is associated with or has cartoons, caricatures, toys,
designs, shapes, labels, or packaging that would appeal to minors.
(c) Package edible
marihuana products in a package that can be easily confused with a commercially
available food product. The use of the word candy or candies on the packaging
or labeling is prohibited.
(d) Produce edible marihuana
products in the distinct shape of a human, animal, or fruit, or a shape that
bears the likeness or contains characteristics of a realistic or fictional
human, animal, or fruit, including artistic, caricature, or cartoon renderings.
Edible marihuana products that are geometric shapes and fruit flavored are
permissible.
(10) An edible marihuana
product must be in opaque, child-resistant packages or containers that meet the
effectiveness specifications outlined in 16 CFR 1700.15. An edible marihuana
product containing more than 1 serving must be in a resealable package or
container that meets the effectiveness specifications outlined in 16 CFR
1700.15.
(a) A product expiration
date, upon which the edible marihuana product is no longer fit for consumption
and after which it must be destroyed. Once a label with an expiration date has
been affixed to an edible marihuana product, a licensee shall not alter that
expiration date or affix a new label with a later expiration date. The
expiration date must consider all the following:
(i) The quality and
characteristics of the edible marihuana product.
(ii) The packaging of the
edible marihuana product.
(iii) The customary
conditions encountered by the edible marihuana product from product to sale.
(b) Any other information
requested by the agency that is not inconsistent with the acts and these rules.
(12) This rule does not
affect the application of any applicable local, state, or federal laws or
regulations. (1) A producer shall not produce a marihuana-infused
beverage without first submitting a request to produce a marihuana-infused
beverage to the agency and receiving approval from the agency.
(2) A producer submitting a request under subrule (1) of this rule shall submit the records of formulation for the marihuana-infused beverage, which must include all of the following:
(a) Ingredients and the source of the ingredients.
(b) Certificates of analysis for all ingredients used in the marihuana-infused beverage.
(c) The recipe.
(d) Documentation verifying that the marihuana-infused beverage is shelf stable.
(e) A detailed description of the ingredients used for emulsification.
(f) Confirmation of package quality and sterility.
(g) A detailed qualitative description of the marihuana-infused beverage, including, but not limited to, the color and appearance of the marihuana-infused beverage.
(3) All of the following apply to the production of a marihuana-infused beverage:
(a) All water used for production must be potable, tested, and treated, as necessary, to ensure safe consumption.
(b) An ingredient with a pH of 3 or higher must be pasteurized either by the producer or the provider of the ingredient.
(c) All emulsifiers and preservatives, and their concentrations, must be listed as safe and adhere to requirements outlined in 21 CFR Part 117.
(d) Except for cannabis, all ingredients in the marihuana-infused beverage must be obtained from FDA-approved sources.
(4) After a producer is approved for the production of a marijuana-infused beverage, the producer shall provide a letter to the agency attesting that no inconsistencies, irregularities, or contaminants were discovered during production. All of the following apply to the letter:
(a) The letter must be signed and dated by the quality control manager or managers.
(b) The letter must be submitted to the agency before the sale or transfer of a new production batch of marihuana-infused beverage to anyone other than a laboratory.
(c) One letter must be submitted for each production batch of marihuana-infused beverage produced.
(5) The agency may relax or waive the requirements in subrule (4) of this rule if a producer demonstrates the capability to produce a stable marihuana-infused beverage over an acceptable period of time, as determined by the agency.
R 420.403a Marihuana-infused beverages; research and product development.
Rule 403a. (1) Before a producer produces a marihuana-infused beverage, the producer shall design a research and product development proposal to determine whether the marihuana-infused beverage maintains product consistency and shelf stability over time.
(2) Before beginning the research and product development required under subrule (1) of this rule, the producer shall submit the proposal to the agency. The producer shall not begin the research and product development until the producer receives approval from the agency.
(3) The research and product development proposal must assess product quality through ongoing checks developed with oversight by the process authority, quality control manager, and the parties associated with good manufacturing processes (GMP) certification, where appropriate.
(4) The duration of the research and product development must correspond to the expiration date of the marijuana-infused beverage.
(5) A portion of the research and product development must be designed to target THC leeching. The concentration of total THC in a beverage cannot degrade by more than the 15% variation allowed under R 420.306c.
(6) The research and product development must include both subjective and objective quality checks of the marihuana-infused beverage over time and provide sufficient data to ensure stability under a variety of environmental conditions and stresses.
(7) The quality checks required in subrule (6) of this rule must include, but are not limited to, all of the following:
(a) Potency.
(b) Stability.
(c) Phase separation.
(d) Color changes.
(e) Clarity.
(f) pH.
(g) Microbial contamination.
(h) Consistency.
(i) Flavor.
(j) Visual changes.
(k) If the product is carbonated, assessment of carbon dioxide (CO2) in solution over time.
(l) Emulsion disability.
(m) Turbidity and sedimentation.
(n) Cloudiness.
(o) Other deteriorative product quality characteristics determined by the producer.
(8) Once a producer chooses a laboratory to perform testing for the research and product development, the producer shall use that laboratory for the entirety of the research and product development unless the producer receives written approval from the agency to use a different laboratory.
R 420.404 Maximum THC
concentration for marihuana-infused products Final packaging.
Rule 4404. A
marihuana sales location shall not sell or transfer marihuana-infused products
that exceed the maximum THC concentrations established by the agency by more
than 10%. For the purposes of maximum THC concentrations for marihuana-infused
products, the agency shall publish a list of maximum THC concentrations and
serving size limits. (1) Marihuana must be sold to a marihuana customer
in a sealed final package.
(2) Except for marihuana flower and marihuana pre-rolls created by a marihuana sales location under R 420.401, marihuana must be sealed in a final package before it is transferred to a marihuana sales location.
(3) Marihuana must be sealed in a final package that meets all of the following requirements:
(a) The final package must be opaque.
(b) The final package must meet the child-resistant effectiveness specifications outlined in 16 CFR 1700.15.
(c) The final package must be resealable and meet the effectiveness specifications outlined in 16 CRF 1700.15.
(d) The final package must be food grade and meet the same standards as packaging required for non-marihuana foods or beverages.
(e) The final package must not use the words “candy” or “candies”.
(f) The final package must not depict cartoons, caricatures, toys, designs, or shapes that would appeal to minors.
R 420. 405 Severability Labeling;
marihuana.
Rule 5405. If
any rule or subrule of these rules, in whole or in part, is found to be invalid
by a court of competent jurisdiction, such decision will not affect the
validity of the remaining portion of these rules. (1) A label must be
affixed to a final package containing marihuana.
(2) The label must include in legible type all of the following information:
(a) The name and the license number of the cultivator or producer, including business
or trade name, and package tag.
(b)The name and the license number of the licensee that packaged the marihuana, including business or trade name, if different from the licensee in subdivision (a) of this subrule.
(c) The date of harvest, if applicable.
(d) The net weight in United States customary or metric units.
(e) Concentration of total THC and Total CBD as reported by the laboratory after potency testing.
(f) A statement that the actual concentration of THC may vary from the reported value by 10%.
(g) Activation time expressed in words or through a pictogram.
(h) The name of the laboratory that performed passing compliance testing on the product in final form and the test analysis date.
(i) The universal symbol for marihuana published by the agency.
(j) The tracking identification numbers assigned by the statewide monitoring system.
(k) The serving size and recommended dose.
(l) If the marihuana is not a marihuana-infused product and contains more than 1 ingredient, the list of ingredients in descending order of predominance by weight.
(m) A warning that includes all the following statements:
(i) “It is illegal to drive a motor vehicle while under the influence of marihuana.”
(ii) “National Poison Control Center 1-800-222-1222.”
(iii) For products being sold by a marihuana facility that exceed the maximum THC levels allowed for products sold under the MRTMA, “For use by registered qualifying patients only. Keep out of reach of children.”
(iv) For all other products, “For use by individuals 21 years of age or older or registered qualifying patients only. Keep out of reach of children.”
(v) In clearly legible type and surrounded by a continuous heavy line: “WARNING: USE BY PREGNANT OR BREASTFEEDING WOMEN, OR BY WOMEN PLANNING TO BECOME PREGNANT, MAY RESULT IN FETAL INJURY, PRETERM BIRTH, LOW BIRTH WEIGHT, OR DEVELOPMENTAL PROBLEMS FOR THE CHILD.”
(n) Other information requested by the agency that is not inconsistent with the acts and these rules.
(3) If marihuana is sold in a multi-pack of final packages and the label affixed to the multi-pack meets the requirements of subrule (2) of this rule, a label must be affixed to each individual final package in the multi-pack that meets, at a minimum, the requirements of subrule (2)(e) and (i) of this rule.
(4) In addition to the requirements of subrules (1), to (3) of this rule, a licensee may include on the label a quick response (QR) code that links to a website containing additional information about the marihuana. The information presented on the website to which the QR code is connected must be factually accurate and applicable to the product on which the label with the QR code is affixed.
R 420.405a Labeling; marihuana-infused products.
Rule 405a. In addition to the requirements in R 420.405, if the marihuana is a marihuana-infused product, the label must include all of the following:
(a) The name of the marihuana-infused product.
(b) One of the following, as applicable, using the same or larger font than the product name:
(i) “Marijuana product”.
(ii) “THC product”.
(iii) “Cannabis product”.
(c) The ingredients, including excipients and diluents, in the marihuana-infused product, in descending order of predominance by weight.
(d) The net weight or net volume of the product.
(e) The date the marihuana-infused product was produced.
R 420.405b Labeling; edible marihuana products.
Rule 405b. In addition to the requirements in R 420.405 and R 420.405a, if the marihuana is an edible marihuana product, the label must include all of the following:
(a) An expiration date, after which the edible marihuana product is no longer fit for consumption and must be disposed of. Once a label with an expiration date is affixed to an edible marihuana product, a marihuana business shall not alter that expiration date or affix a new label with a later expiration date, except to correct an obvious error.
(b) Allergen labeling as specified by the FDA, Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), 21 USC 343.
(c) If a health or nutritional claim is made, appropriate labeling as specified by the federal regulations regarding food labeling, 21 CFR part 101.
R 420.406 Maximum THC concentrations in marihuana-infused products.
Rule 406. (1) The THC concentration in a marihuana-infused product must not exceed the maximum limits in table 1:
TABLE 1
Maximum THC Concentrations for Marihuana-Infused Products |
||||
Category |
Medical |
Medical |
Adult-Use |
Adult-Use |
Infused edibles (gummies, baked goods, drink enhancers, syrup) |
50mg |
200mg |
10mg |
200mg |
Medicinal products (capsules, tinctures, oil-based drops, etc.) |
100mg |
2,000mg |
10mg |
200mg |
Medicinal products not consumed orally (suppositories, tampons, transdermal patches) |
100mg |
2,000mg |
100mg |
2,000mg |
Infused Beverages |
10mg |
100mg |
10mg |
100mg |
Topical Products |
N/A |
(2) The concentration of delta-8 THC in a marihuana-infused product must not exceed 10%.
(3) A marihuana business shall not create, sell, or transfer a marihuana-infused product that exceeds the maximum THC amounts in table 1 by more than 10%.
R 420.407 Product development.
Rule 407. (1) A cultivator, producer, marihuana microbusiness, or class A marihuana microbusiness may engage in product development.
(2) A cultivator, marihuana microbusiness, or class A marihuana microbusiness may designate marihuana plants for product development. Marihuana plants designated for product development count toward the authorized total amount of marihuana plants for a cultivator, marihuana microbusiness, or class A marihuana microbusiness.
(3) A producer, marihuana microbusiness, or class A marihuana microbusiness may designate marihuana concentrate for product development.
(4) A marihuana business engaged in product development may submit their product development inventory to a laboratory for research and development testing in accordance with R 420.312.
(5) Disciplinary action must not be taken against a licensee for failing a research and development test performed on their product development inventory.
(6) A marihuana business engaged in product development may transfer its product development inventory to either of the following if the marihuana passed full compliance testing under part 5 of these rules:
(a) An employee of the marihuana business as an internal product sample.
(b) A marihuana sales location. Product development inventory transferred to a marihuana sales location must meet all other requirements prescribed under this part.
(7) A marihuana business shall dispose of any product development inventory not transferred under subrule (6) of this rule.
(8) A cultivator, producer, marihuana microbusiness, or class A marihuana microbusiness may also engage in a research study with an entity duly authorized by the DEA to handle marihuana. A licensee’s participation in a research study must be approved by the agency.
R 420.408 Trade samples.
Rule 408. (1) A cultivator or producer may transfer a trade sample of marihuana to a producer or marihuana sales location if the marihuana from which the trade sample was taken has passed full compliance testing under part 5 of these rules.
(2) A marihuana business that receives a trade sample shall not transfer the trade sample to another marihuana business or to a marihuana consumer.
(3) A marihuana business shall not transfer to another marihuana business more than either of the following amounts of marihuana in a 30-day period:
(a) 2.5 ounces of marihuana.
(b) 15 grams of marihuana concentrate.
(4) In addition to the information required in R 420.405, a trade sample must have a label containing the statement “TRADE SAMPLE NOT FOR RESALE” in bold, capital letters attached to the trade sample.
(5) A marihuana business that receives a trade sample may transfer the trade sample to an employee as an internal product sample under R 420.409.
R 420.409 Internal product samples.
Rule 409. (1) A cultivator, producer, marihuana sales location, marihuana microbusiness, or class A marihuana microbusiness may transfer an internal product sample to an employee of the cultivator, producer, marihuana sales location, marihuana microbusiness, or class A marihuana microbusiness to ensure product quality and to make determinations about whether to sell or transfer the marihuana.
(2) A marihuana business shall not transfer to an individual employee more than the following amounts of marihuana in a 30-day period:
(a) For a cultivator, 1 ounce of marihuana.
(b) For a producer, an amount that exceeds either of the following:
(i) 6 grams of marihuana concentrate.
(ii) Marihuana-infused products that contain a total of 2,000 milligrams of THC.
(c) For a marihuana sales location, marihuana microbusiness, or class A marihuana microbusiness, an amount that exceeds any of the following:
(i) One ounce of marihuana.
(ii) Six grams of marihuana concentrate.
(iii) Marihuana-infused products that contain a total of 2,000 milligrams of THC.
(3) A marihuana business shall not create an internal product sample unless the marihuana from which the internal product sample was taken has passed full compliance testing under part 5 of these rules.
(4) Internal product samples must be tracked as adjustments in the statewide monitoring system.
DEPARTMENT OF
LICENSING AND REGULATORY AFFAIRS
MARIJUANA
REGULATORY AGENCY
PART 7. MARIHUANA
SALE OR TRANSFERSALES
(By authority conferred on the
executive director of the marijuana regulatory agency by section 206 of the
medical marihuana facilities licensing act, 2016 PA 281, MCL 333.27206,
sections 7 and 8 of the Michigan Regulation and Taxation of Marihuana Act, 2018
IL 1, MCL 333.27957 and 333.27958, and Executive Reorganization Order No.
2019-2, MCL 333.27001)
R 420.501 Definitions Sale
or transfer of marihuana; marihuana sales location.
Rule 1501. (1)
As used in these rules:
(b) “Administrative hold”
means a status given to marihuana product by the agency during an investigation
into alleged violations of the acts and these rules. This status includes no
sale or transfer of the marihuana product until the hold is lifted.
(c) “Agency” means the
marijuana regulatory agency.
(d) “Cultivator” means a
grower under the medical marihuana facilities licensing act or a marihuana
grower under the Michigan Regulation and Taxation of Marihuana Act, or both.
(e) “Designated consumption
establishment” means a commercial space that is licensed by the agency and
authorized to permit adults 21 years of age and older to consume marihuana
products at the location indicated on the state license.
(f) “Employee” means a
person performing work or service for compensation. “Employee” does not include
individuals providing trade or professional services who are not normally
engaged in the operation of a marihuana business.
(g) “Final form” means the
form a marihuana product is in when it is available for sale by a marihuana
sales location not including consumer packaging. For marihuana products
intended for inhalation, final form means the marihuana concentrate in an
e-cigarette or a vaping device.
(h)"Immature plant”
means a nonflowering marihuana plant that is no taller than 8 inches from the
growing or cultivating medium and no wider than 8 inches produced from a
cutting, clipping, tissue culture, or seedling that is in a growing or cultivating
medium or in a growing or cultivating container.
(i) “Internal product
sample” means a sample of marijuana products that a cultivator, producer, or
marihuana sales location transfers directly to an employee for the purpose of
ensuring product quality and making determinations about whether to sell or
transfer the marihuana product.
(j) “Laboratory” refers to
a safety compliance facility under the medical marihuana facilities licensing
act or a marihuana safety compliance facility under the Michigan Regulation and
Taxation of Marihuana Act, or both.
(k) “Marihuana business”
refers to a marihuana facility under the medical marihuana
facilities licensing act or a
marihuana establishment under the Michigan Regulation and Taxation of Marihuana
Act, or both.
(l) “Marihuana customer”
refers to a registered qualifying patient or registered primary caregiver under
the medical marihuana facilities licensing act, or an individual 21 years of
age or older under the Michigan Regulation and Taxation of Marihuana Act, or
both.
(m) “Marihuana equivalent”
means usable marihuana equivalent as that term is defined in section 3(o) of
the Michigan Medical Marihuana Act, MCL 333.264243.
(n) “Marihuana
establishment” means a location at which a licensee is licensed to operate a
marihuana grower, marihuana safety compliance facility, marihuana processor,
marihuana microbusiness, class A marihuana microbusiness, marihuana retailer,
marihuana secure transporter, or any other type of marihuana related business
licensed to operate by the agency under the Michigan Regulation and Taxation of
Marihuana Act.
(o) “Marihuana facility”
means a location at which a licensee is licensed to operate under the medical
marihuana facilities licensing act.
(p) “Marihuana license”
means a state operating license issued under the medical marihuana facilities
licensing act, or a state license issued under the Michigan Regulation and
Taxation of Marihuana Act, or both.
(q) “Marihuana product”
means marihuana or a marihuana-infused product, or both, as those terms are
defined in the acts unless otherwise provided for in these rules.
(r) “Marihuana sales
location” refers to a provisioning center under the medical marihuana
facilities licensing act, or a marihuana retailer, marihuana microbusiness, or
class A marihuana microbusiness under the Michigan Regulation and Taxation of
Marihuana Act, or both.
(s) “Marihuana tracking
act” means the marihuana tracking act, 2016 PA 282, MCL 333.27901 to 333.27904.
(t) “Medical marihuana
facilities licensing act” or “MMFLA” means the medical marihuana facilities
licensing act, 2016 PA 281, MCL 333.27101 to 333.27801.
(u) “Michigan Medical
Marihuana Act” means the Michigan Medical Marihuana Act, 2008 IL 1, MCL 333.26421
to 333.26430.
(v) “Michigan Regulation
and Taxation of Marihuana Act” or “MRTMA” means the Michigan Regulation and
Taxation of Marihuana Act, 2018 IL 1, MCL 333.27951 to 333.27967.
(w) “Package tag” means an
RFID tag supplied through the statewide monitoring system for the purpose of
identifying a package containing a marihuana product.
(x) “Plant” means that term
as defined in section 102 of the MMFLA, MCL 333.27102, unless otherwise defined
in these rules.
(y) “Producer” means a
processor under the medical marihuana facilities licensing act or a marihuana
processor under the Michigan Regulation and Taxation of Marihuana Act, or both.
(z) “These rules” means the
administrative rules promulgated by the agency under the authority of the
medical marihuana facilities licensing act, the marihuana tracking act, the
Michigan Regulation and Taxation of Marihuana Act, and Executive Reorganization
Order No. 2019-2, MCL 333.27001.
(aa) “Tag” or “RFID tag”
means the unique identification number or Radio Frequency Identification (RFID)
issued to a licensee by the statewide monitoring system for tracking,
identifying, and verifying marihuana plants, marihuana products, and packages
of marihuana products in the statewide monitoring system.
(bb) “Trade sample” means a
sample of marihuana products that a cultivator or producer provides to
licensees for the purpose of the licensee determining whether to purchase the
marihuana product.
(2) Terms defined in the
acts have the same meanings when used in these rules unless otherwise
indicated. (1) A marihuana sales location shall do both of the
following:
(a) Keep marihuana behind a counter or other barrier to ensure that a customer does not have direct access to the marihuana.
(b) If the marihuana sales location is a marihuana microbusiness or class A marihuana microbusiness, have a separate room that is dedicated as the point-of-sale area for the transfer or sale of marihuana to marihuana customers that is separate from areas used for cultivating or processing.
(2) A marihuana sales location shall verify all of the following before selling or transferring marihuana to a marihuana customer:
(a) The marihuana has not been placed on administrative hold or recalled and is not required to be disposed of.
(b) If the marihuana is an edible marihuana product, the marihuana is not past its expiration date.
(c) The completed transfer or sale will not exceed the purchasing limit prescribed in R 420.506.
(d) The marihuana has passed all testing required under part 5 of these rules.
(e) The marihuana meets the packaging and labeling requirements under part 6 of these rules.
(3) In addition to the requirements in subrule (2) of this rule, before selling or transferring marihuana to a marihuana customer, a marihuana retailer, marihuana microbusiness, or class A marihuana microbusiness shall verify the marihuana customer is 21 years of age or older. The marihuana retailer, marihuana microbusiness, or class A marihuana microbusiness shall verify that the marihuana customer is 21 years of age or older by requiring the marihuana customer to present a valid driver’s license or government-issued identification card that bears a photographic image of the marihuana customer.
(4) In addition to the requirements in subrule (2) of this rule, before selling or transferring marihuana to a marihuana customer, a provisioning center shall verify that the marihuana customer is 1 of the following:
(a) A registered qualifying patient or primary caregiver. The provisioning center shall verify the marihuana customer is a registered qualifying patient or primary caregiver by requiring the marihuana customer to present a valid, current, unexpired, and unrevoked registry identification card.
(b) A visiting qualifying patient. The provisioning center shall verify the marihuana customer is a visiting qualifying patient by requiring the marihuana customer to present both of the following:
(i) The equivalent of a registry identification card issued in another state, district, territory, commonwealth, or insular possession of the United States that allows the medical use of marihuana.
(ii) A valid driver’s license or government-issued identification card that bears a photographic image of the visiting qualifying patient.
(5) As used in subrule (4) of this rule, “visiting qualifying patient” means that term as defined in section 3 of the Michigan Medical Marihuana Act, MCL 333.26423.
(6) A marihuana sales location shall maintain the following records for each sale or transfer of marihuana:
(a) A description of the marihuana.
(b) The quantity of marihuana.
(c) The date and time of the sale or transfer.
(d) The payment method.
(e) The amount of payment.
(6) A marihuana sales location may accept orders for marihuana and payment for marihuana online and by telephone.
(7) A marihuana sales location shall not sell marihuana obtained from a registered primary caregiver.
R 420.502 Tracking
identification; labeling requirements; general Marihuana delivery.
Rule 2502. (1)
Each marihuana products sold or transferred must be clearly labeled with the
tracking identification numbers assigned by the statewide monitoring system
affixed, tagged, or labeled and recorded, and any other information required by
the agency, the acts, and these rules.
(2) The agency may place an
administrative hold on marihuana products, recall marihuana products, issue
safety warnings, and require a marihuana business to provide informational
material or notifications to a marihuana customer at the point of sale.
(3) A marihuana business
shall not sell or transfer a marihuana product that has been placed on
administrative hold, recalled, or ordered or otherwise required to be
destroyed.
(4) A marihuana business
shall not sell or a transfer marihuana product after the printed expiration
date on the package. An expired marihuana product must be destroyed except as
provided in R 420.214c(2)(f).
(5) Prior to selling or
transferring a marihuana product, a marihuana business must verify in the statewide
monitoring system, that the marihuana product has not been placed on an
administrative hold, recalled, or ordered to be destroyed.
(6) A marihuana business
shall destroy all product required to be destroyed for any reason within 90
calendar days of when the marihuana business became aware of the fact that the
product must be destroyed. (1) A marihuana sales location may engage in
the delivery of marihuana to marihuana customers on approval by the agency.
(2) A marihuana sales location shall establish delivery procedures to ensure marihuana deliveries comply with the requirements in subrule (3) of this rule.
(3) All of the following apply to the delivery of marihuana by a marihuana sales location:
(a) If the marihuana sales location is licensed under the MMFLA, marihuana must be delivered to 1 of the following:
(i) The residential address of a registered qualifying patient.
(ii) If a registered qualifying patient is a minor, the residential address of the minor’s registered primary caregiver.
(b) If the marihuana sales location is licensed under the MRTMA, marihuana must be delivered to 1 of the following:
(i) The residential address of an individual 21 years of age or older.
(ii) A designated consumption establishment.
(c) Marihuana must be delivered by an employee of the marihuana sales location.
(d) The amount of marihuana delivered to a marihuana customer must not exceed the purchase limits in R 420.506.
(e) The marihuana delivery employee shall verify that the person accepting the delivery is the individual who placed the order.
(f) The marihuana delivery employee shall verify the identity and age of the marihuana customer as required in R 420.501(3) or (4).
(g) A marihuana delivery employee shall have access to a mobile communication device at all times in the vehicle or on their person while making marihuana deliveries.
(h) A marihuana delivery employee shall maintain a physical or electronic copy of the delivery request while making a marihuana delivery.
(i) A marihuana delivery employee shall not leave marihuana unattended in a delivery vehicle unless the vehicle is locked and equipped with an active vehicle alarm system.
(j) A marihuana delivery employee shall use a motor vehicle as that term is defined in the Michigan vehicle code, 1949 PA 300, MCL 257.1 to 257.923, to deliver marihuana.
(k) A marihuana delivery vehicle must contain a global positioning system device while the vehicle is being used to make a marihuana delivery. The marihuana sales location shall be able to identify the geographic location of a marihuana delivery vehicle and marihuana delivery employee while the employee is delivering marihuana.
(l) A marihuana delivery employee shall not possess more than either of the following while making deliveries:
(i) $5,000.00 worth of marihuana. The value of the marihuana must be determined using the current retail price of the marihuana.
(ii) If the marihuana delivery employee is delivering marihuana for a marihuana retailer under the MRTMA, more than 15 ounces of marihuana or more than 60 grams of marihuana concentrate under section 11 of the MRTMA, MCL 333.27961.
(m) If a marihuana delivery employee returns to the marihuana sales location with undelivered marihuana, the marihuana must be returned to inventory and the marihuana sales location shall update the statewide monitoring system within 24 hours.
(n) All marihuana deliveries must occur during the business hours of the marihuana sales location.
(o) Marihuana being delivered by a marihuana delivery employee must be transported in a container that is secured by a locked, closed lid or door, or sealed by a tamper-proof tape that indicates if the marihuana had been tampered with during transport.
(4) A marihuana delivery begins when the marihuana delivery employee leaves the premises of a marihuana sales location with marihuana. The marihuana delivery ends when the marihuana delivery employee returns to the premises of the marihuana sales location after delivering the marihuana to the marihuana customer or to return undelivered marihuana.
(5) A marihuana sales location shall report to the agency anything that occurs during a marihuana delivery that violates the marihuana sales location’s marihuana delivery procedure.
(6) A marihuana delivery employee may be employed by more than 1 marihuana sales location if 1 licensee holds the licenses for all marihuana sales locations at which the marihuana delivery employee is employed. A marihuana delivery employee who is employed by more than 1 marihuana sales location may only deliver marihuana for 1 marihuana sales location at a time.
(7) The approval granted to a marihuana sales location pursuant to subrule (1) of this rule may be denied, suspended, or withdrawn by the agency.
R 420.503 Marihuana plant;
tracking requirements Delivery; records.
Rule 3503. Before
a marihuana plant is sold or transferred, a package tag must be affixed to the
plant or plant container and enclosed in a tamper proof seal that includes all
of the following information:
(a) Business or trade name,
licensee number, and the RFID package tag assigned by the statewide monitoring
system that is visible.
(b) Name of the strain.
(c) Date of harvest.
(d) Seed strain.
(e) Universal symbol. (1)
A marihuana sales location shall maintain records of all of the following for a
marihuana delivery:
(a) Confirmation of compliance with R 420.502(3)(a) or (b).
(b) Confirmation of compliance with R 420.502(3)(f).
(c) Documentation that a marihuana customer consented to the delivery of the marihuana and the release of information necessary in fulfilling the delivery.
(d) A marihuana delivery log that records all of the following:
(i) The date and time that the delivery began and ended.
(ii) The date, time, and location of the stops made during the marihuana delivery and the reason for the stop.
(ii) The name of the marihuana delivery employee.
(iii) The amount of marihuana delivered.
(iv) The package tag number or numbers of the marihuana.
(v) The signature of the individual who accepted delivery.
(2) A marihuana sales location shall maintain the following records for a motor vehicle used for marihuana delivery:
(a) Vehicle make.
(b) Vehicle model.
(c) Vehicle color.
(d) Vehicle identification number.
(e) License plate number.
(f) Vehicle registration.
(g) Proof of insurance.
(3) A marihuana delivery employee shall carry a physical or electronic copy of all of the following information when making a marihuana delivery for a marihuana sales location:
(a) The identification number for the marihuana delivery employee assigned by the statewide monitoring system.
(b) The license number of the marihuana sales location.
(c) The address of the marihuana sales location.
(d) The telephone number of the marihuana sales location.
(e) A copy of the delivery log required in subrule (1)(d) of this rule.
(f) A delivery inventory ledger that identifies all marihuana possessed by the marihuana delivery employee. For each final package of marihuana, the delivery inventory ledger must include all of the following:
(i) The type of marihuana.
(ii) The brand name of the marihuana.
(iii) The retail value of the marihuana.
(iv) The tag number associated with the marihuana.
(v) The weight, volume, or other accurate measure of the amount of marihuana.
(g) Documentation of a delivery order for marihuana in the delivery vehicle and receipts for marihuana that has already been delivered to customers.
R
420.503a Sale or transfer of immature plant batches from a cultivator to a
marihuana
sales location. Rescinded.
Rule 3a. (1) A cultivator
approved by the agency to sell or transfer immature plant batches to a
marihuana sales location is not required to transfer the immature plant batches
using a marihuana transporter.
(2) Immature plant batches
transferred from a cultivator to a marihuana sales location are not required to
undergo the testing required by R 420.304 and R 420.305.
Rule 4504. (1) Before
a marihuana product is sold or transferred to or by a marihuana sales location,
the container, bag, or product holding the marihuana product must be sealed and
labeled with all of the following information:
(a) The name and the state
license number of the cultivator or producer, including business
or trade name, and package tag
as assigned by the statewide monitoring system.
(b)The name and the
marihuana license number of the licensee that packaged the product, including
business or trade name, if different from the producer of the marihuana
product.
(c) Date of harvest, if
applicable.
(d) Name of strain, if
applicable.
(e) Net weight in United
States customary or metric units.
(f) Concentration of
Tetrahydrocannabinol (THC) and cannabidiol (CBD) as reported by the laboratory
after potency testing along with a statement that the actual value may vary
from the reported value by 10%.
(g) Activation time
expressed in words or through a pictogram.
(h) Name of the laboratory that performed any passing compliance testing on the
product in final form and any test analysis date.
(i) The universal symbol
for marihuana product published on the agency’s website.
(j) A warning that includes
all the following statements:
(i) "It is illegal to
drive a motor vehicle while under the influence of marihuana."
(ii) “National Poison
Control Center 1-800-222-1222.”
(iii) For products being
sold by a marihuana facility that exceed the maximum THC levels allowed for
products sold under MRTMA, “For use by registered qualifying patients only.
Keep out of reach of children.”
(iv) For all other
products, “For use by individuals 21 years of age or older or registered
qualifying patients only. Keep out of reach of children.”
(v) In clearly legible
type and surrounded by a continuous heavy line: “WARNING: USE BY PREGNANT OR
BREASTFEEDING WOMEN, OR BY WOMEN PLANNING TO BECOME PREGNANT, MAY RESULT IN
FETAL INJURY, PRETERM BIRTH, LOW BIRTH WEIGHT, OR DEVELOPMENTAL PROBLEMS FOR
THE CHILD.”
(2) An edible marihuana
product sold by a marihuana sales location must comply with R 420.403(7) to
(10).
(3) An infused marihuana
product sold by a marihuana sales location must comply with R 420.403(7).
(4) A marihuana sales
location must make available to every customer at the time of sale a pamphlet
measuring at least 3.5 inches by 5 inches, that includes, at minimum, the
statement “National Poison Control Center Hotline 1-800-222-1212,” and at least
two of the following statements:
(a) Marijuana use
during adolescence may affect the developing brain negatively by impairing
thinking and problem solving.
(b) Marijuana use
during adolescence may affect the developing brain negatively by impairing
memory and learning.
(c) Marijuana use
during adolescence may affect the developing brain negatively by impairing
coordination.
(d) Marijuana use
during adolescence may affect the developing brain negatively by impairing
ability to maintain attention.
(e) Marijuana use
during adolescence may impact performance in school.
(f) Marijuana use
during adolescence may impact the risk of mental health issues.
(g) Marijuana use
during adolescence may impact driving abilities.
(h) Marijuana use
during adolescence may impact the potential for addiction.
(i) Any other
statement as approved by the agency and published on the agency’s website. (1)
A marihuana sales location may designate an area for contactless or limited
contact transactions unless prohibited by an ordinance adopted by the
municipality where the marihuana sales location is located.
(2) Contactless or limited contact transactions include, but are not limited to, both of the following:
(a) Curbside service.
(b) Drive through window service.
(3) A contactless or limited contact transaction must comply with the requirements of R 420.501.
(4) The designated area for contactless or limited contact transactions must be identified in the marihuana business location plan.
(5) A marihuana sales location providing contactless or limited contact transactions shall have a written standard operating procedure in place.
(6) Contactless or limited contact transactions must be completed during normal business hours.
(7) A marihuana sales location offering contactless or limited contact transactions shall ensure that only the marihuana customer that placed the order can access the marihuana.
(8) A marihuana sales location transferring marihuana to a marihuana customer during a contactless or limited contact transaction shall ensure that the marihuana is not visible to the general public during the contactless or limited contact transaction.
R 420.505 Sale or transfer;
marihuana sales location Informational pamphlet requirements.
Rule 5505. (1)
A marihuana sales location shall verify all of the following prior to selling
or transferring marihuana or a marihuana product to a marihuana customer:
(a) The marihuana product
has not been placed on administrative hold, recalled, or ordered or otherwise
required to be destroyed.
(b) The marihuana product
is not past its expiration date.
(c) The marihuana customer
presented his or her valid driver’s license or government-issued identification
card that bears a photographic image of the qualifying patient or primary
caregiver, under the MMFLA; or bears a photographic image and proof that the
individual is 21 years of age or older, under the MRTMA.
(d) The completed transfer
or sale will not exceed the purchasing limit prescribed in R 420.506.
(e) The marihuana product
has been tested in accordance with R 420.305.
(f) The marihuana product
is labeled and packaged for sale or transfer in accordance with R 420.504.
(g) The registered
qualifying patient or registered primary caregiver holds a valid, current,
unexpired, and unrevoked registry identification card.
(2) A marihuana sales
location shall enter all transactions, current inventory, and other information
required by these rules in the statewide monitoring system. The marihuana
sales location shall maintain appropriate records of all sales or transfers
under the acts and these rules and make them available to the agency upon
request.
(3) A provisioning center
licensed under the MMFLA shall verify all of the following prior to selling or
transferring a marihuana product to a visiting qualifying patient:
(a) The visiting qualifying
patient has a valid unexpired medical marihuana registry card, or its
equivalent issued in another state, district, territory, commonwealth, or
insular possession of the United States that allows the medical use of
marihuana.
(b) The visiting qualifying
patient presented his or her valid driver license or government-issued
identification card that bears a photographic image of the visiting qualifying
patient.
(c) The transfer or sale,
if completed, will not exceed the purchasing limit prescribed in R 420.506.
(d) The marihuana product
that is sold or transferred under this rule has been tested in accordance with
R 420.305.
(e) The marihuana product
is labeled and packaged for sale or transfer in accordance with R 420.504.
(f) As used in this
subrule, “visiting qualifying patient” means that term as defined in section 3
of the Michigan Medical Marihuana Act, MCL 333.26423.
(4) A marihuana retailer,
marihuana microbusiness, or class A marihuana microbusiness licensed under the
MRTMA is not required to retain information from customers other than the
following:
(a) Payment method.
(b) Amount of payment.
(c) Time of sale.
(d) Product quantity.
(e) Other product
descriptors. A marihuana sales location shall make available to every
customer at the time of sale a pamphlet measuring not less than 3-1/2 by 5
inches, that includes, at minimum, the statement “National Poison Control
Center Hotline 1-800-222-1222,” and not less than 2 of the following
statements:
(a) Marijuana use during adolescence may affect the developing brain negatively by impairing thinking and problem solving.
(b) Marijuana use during adolescence may affect the developing brain negatively by impairing memory and learning.
(c) Marijuana use during adolescence may affect the developing brain negatively by impairing coordination.
(d) Marijuana use during adolescence may affect the developing brain negatively by impairing ability to maintain attention.
(e) Marijuana use during adolescence may impact performance in school.
(f) Marijuana use during adolescence may impact the risk of mental health issues.
(g) Marijuana use during adolescence may impact driving abilities.
(h) Marijuana use during adolescence may impact the potential for addiction.
(i) Another statement as approved and published by the agency.
R 420.506 Purchasing limits; transactions; marihuana sales location.
Rule 6506. (1) Before the sale or
transfer of marihuana product to a registered qualifying patient or registered
primary caregiver, under the MMFLA, the licensee shall verify in the statewide
monitoring system that the sale or transfer does not exceed either of the daily
purchasing limits as followsA provisioning center shall not transfer
more than the following amounts of marihuana to a marihuana customer:
(a) ForTo a
registered qualifying patient, an amount of marihuana product that does not,
in total, exceed 2.5 ounces of marihuana or marihuana equivalent per
day.
(b) ForTo a
registered primary caregiver, an amount of marihuana product that does not,
in total, exceed 2.5 ounces of marihuana or marihuana equivalent per
day for each registered qualifying patient with whom he or shethe
registered primary caregiver is connected through the agency’s registration
process.
(c) To a registered qualifying patient, 10 ounces of marihuana in a 30-day period, either directly or through the registered qualifying patient’s registered primary caregiver.
(2) Before the sale or
transfer of marihuana product to a registered qualifying patient or registered
primary caregiver, under the MMFLA, the licensee shall verify in the statewide
monitoring system that the sale or transfer does not exceed the monthly
purchasing limit of 10 ounces of marihuana product per month to a qualifying
patient, either directly or through the qualifying patient’s registered primary
caregiver.
(32) A marihuana
retailer, under the MRTMA, is prohibited from making a sale or transferring
marihuana to an adult 21 years of age or older in a single transaction that
exceeds 2.5 ounces., Not more than 15 grams of marihuana may be in the form of
marihuana concentrateshall not sell or transfer more than 2.5 ounces of
marihuana to a marihuana customer 21 years of age or older in a single
transaction. Of that, not more than 15 grams may be in the form of marihuana concentrate.
(43) A marihuana
sales location may sell noshall not sell more than 3 immature
plants to a marihuana customer per transaction.
(4) When determining the amount of marihuana being sold or transferred under this rule, the following quantities are considered equivalent to 1 ounce of marihuana:
(a) Sixteen ounces of marihuana-infused product if the marihuana-infused product is in a solid form.
(b) Thirty-six ounces of marihuana-infused product if the marihuana-infused product is in a liquid form.
R 420.507 Marketing and advertising restrictions.
Rule 7507. (1) A
marihuana product may only be advertised or marketedlicensee shall
only advertise or market marihuana or a marihuana brand in compliance with
all applicable municipal ordinances, state law, and these rules that
regulate signs and advertisingthis rule.
(2) A licensee mayshall
not advertise a marihuana product or a marihuana brand in
a way that is deceptive, false, or misleading, or make any deceptive,
false, or misleading assertions or statements on any packages of
marihuana product, signs, or documents provided.
(3) Marihuana product
marketing, advertising, packaging, and labeling must not containA
licensee shall not include anya claim related to health or
health benefits on marketing, advertising, or packaging for marihuana or a
marihuana brand, unless a qualified health claim has receivedreceives
and complies with a Letter of Enforcement Discretion issued by the United
States Food and Drug Administration (FDA)FDA, or the health claim has
beenis approved under the significant scientific agreement standard
by the FDA.
(4) A marihuana product must
not be advertised or marketedlicensee shall not advertise or market
marihuana or a marihuana brand to members of the public unless the personlicensee
advertising the productmarihuana or marihuana brand has reliable
evidence that no more than 30% of the audience or readership for the television
program, radio program, internet website, or print publication,advertising
or marketing is reasonably expected to be under the age listed in subrules
(7) and (8) of this rule. Any marihuana product advertised or marketed must
include the warnings listed in R 420.504(1)(j).
(5) A person receiving
reasonable payment under a licensing agreement or contract approved by the
agency concerning the licensing of intellectual property, including, but not
limited to, brands and recipes, is responsible for any marketing or advertising
undertaken by either party to the agreementlicensee is responsible for
ensuring that the marketing and advertising of marihuana and marihuana brands
that is done pursuant to an agreement between the licensee and another party
complies with the acts and these rules.
(6) A marihuana productMarihuana
or a marihuana brand marketed or advertised under the MMFLA must be
marketed or advertised as “medical marihuana” for use only by registered
qualifying patients or registered primary caregivers.
(7) A marihuana product
marketed or advertisedlicensee under the MMFLA mustshall
not be marketed or advertised to minors aged 17 years or youngermarket
or advertise marihuana or a marihuana brand in a way that appeals to
individuals less than 18 years of age. Sponsorships targeting individuals aged
17 years or younger less than 18 years of age are prohibited.
(8) A licensee under the MRTMA shall not market or advertise marihuana or a marihuana brand in a way that appeals to individuals less than 21 years of age. Sponsorships targeting individuals less than 21 years of age are prohibited.
(89) A marihuana
product marketed or advertisedlicensee under the MRTMA must shall
be marketed or advertised as “marihuana”market and advertise
marihuana as being for use only by individuals 21 years of age or
older.
(9) A marihuana product
marketed or advertised under the MRTMA must not be marketed or advertised to
individuals under 21 years of age. Sponsorships targeting individuals under 21
years of age are prohibited.
(10) Advertising or marketing for marihuana or a marihuana brand must include the warnings listed in R 420.405(2)(m).
R 420.508 Trade samples Advertising
marihuana that has not been treated.
Rule 8508. (1)
The following licensees may provide trade samples:
(a) A cultivator may
transfer trade samples of marihuana products to a producer or a marihuana sales
location.
(b) A producer may transfer
trade samples of marihuana products to a producer or marihuana sales location.
(2) The transfer of trade
samples does not require the use of a secure transporter under the MMFLA or a
marihuana secure transporter under the MRTMA if the amount of trade samples
does not exceed either of the following:
(a) 15 ounces of marihuana.
(b) 60 grams of marihuana
concentrate.
(3) Trade samples must not
be sold or transferred by the receiving producer or marihuana sales location to
another producer or marihuana sales location or to a consumer.
(4) Any trade sample
transferred to a producer or marihuana sales location or received by a producer
or a marihuana sales location must be recorded in the statewide monitoring
system.
(5) Any trade samples
transferred under this rule must be tested in accordance with these rules prior
to being transferred to a producer or marihuana sales location.
(6) A cultivator and
producer are limited to transferring the following aggregate amounts of trade
samples to a producer or a marihuana sales location in a 30-day period:
(a) 2.5 ounces of
marihuana.
(b) 15 grams of marihuana
concentrate.
(7) In addition to the
information required in R 420.403, a trade sample must have a label containing
the statement “TRADE SAMPLE NOT FOR RESALE” in bold, capital letters attached
to the trade sample.
(8) A producer or marihuana
sales location that receives a trade sample may distribute the trade sample to
its employees to determine whether to purchase the marihuana product. A
producer or marihuana sales location is limited to transferring a total of 1
ounce of marihuana, a total of 6 grams of marihuana concentrate, and marihuana
infused products with a total THC content of 2000 mgs of internal product
samples to each of its employees in a 30-day period. (1) A marihuana
business may include the statement “This product has not been treated with
radiation, gas, radio frequency, chemical, or thermal processing” on final
packaging or in advertising only if the marihuana in the final packaging or
being advertised has not undergone any of the following treatments or
processes:
(a) Ionizing radiation.
(b) Non-ionizing radiation.
(c) Gas treatment.
(d) Chemical application.
(e) Radio frequency decontamination.
(f) Thermal processing.
(2) As used in this rule:
(a) “Ionizing radiation” means a treatment or process in which a marihuana business subjects marihuana to focused gamma radiation, x-radiation, or other photonic radiation.
(b) “Non-ionizing radiation” means a treatment or process in which a marihuana business exposes marihuana to ultraviolet light.
(c) “Gas treatment” means a treatment or process in which a marihuana business subjects marihuana to ozone, propylene oxide, ethylene oxide, or sulfur dioxide.
(d) “Chemical application” means a treatment or process in which a licensee sprays or otherwise applies hydrogen peroxide or bleach to marihuana.
(e) “Radio frequency decontamination” means a treatment or process in which a licensee exposes marihuana to focused radio waves.
(f) “Thermal processing” means a treatment or process in which a licensee subjects marihuana to a heat source, including radio waves, which causes the marihuana temperature to rise above 120 degrees Fahrenheit.
(3) A marihuana business shall not include the phrase in subrule (1) of this rule or a similar phrase that could lead a reasonable marihuana customer to believe marihuana had not undergone a treatment or process listed in subrule (1) of this rule on the final packaging or in other advertising if the marihuana in the final packaging or being advertised has undergone a treatment listed in subrule (1) of this rule.
R 420.509 Internal product
samples. Rescinded.
Rule 9. (1) A cultivator,
producer, marihuana sales location, or marihuana microbusiness, or class A
marihuana microbusiness may transfer internal product samples directly to its
employees for the purpose of ensuring product quality and making determinations
about whether to sell the marihuana product.
(2) Internal product samples
may not be transferred or sold to another licensee or consumer.
(3) A licensee shall record
the transfer of an internal product sample in the statewide monitoring system.
(4) A cultivator is limited
to transferring a total of 1 ounce of internal product samples to each of its
employees in a 30-day period.
(5) A producer is limited to
transferring a total of 6 grams of marihuana concentrate and marihuana infused
products with a total THC content of 2000 mgs of internal product samples to
each of its employees in a 30-day period.
(6) A marihuana sales
location, marihuana microbusiness, and class A marihuana microbusiness are
limited to transferring a total of 1 ounce of marihuana, a total of 6 grams of
marihuana concentrate, and marihuana infused products with a total THC content
of 2000 mgs of internal product samples to each of its employees in a 30-day
period.
(7) A licensee shall have
internal product samples tested pursuant to R 420.304 and R 420.305 before
transfer to its employees.
R 420.510 Product
development. Rescinded.
Rule 10. (1) A cultivator or
producer may engage in product development. No other marihuana business may
engage in product development.
(2) A cultivator may
designate marihuana plants for product development. Any marihuana plants
designated for product development count toward the authorized total amount of
marihuana plants for a cultivator and must be tracked in the statewide
monitoring system.
(3) A producer may designate
marihuana concentrate for product development. Any marihuana concentrates
designated for product development must be tracked in the statewide monitoring
system.
(4) A licensee engaged in
product development may submit his or her product development inventory to a
laboratory for research and development testing in accordance with these
rules.
(5) Disciplinary action may
not be taken against a licensee for failed research and development test
results on his or her product development inventory.
(6) A cultivator or producer
may transfer its product development inventory to its employees for
consumption. A licensee shall have product development inventory tested
pursuant to R 420.304 and R 420.305 before transferring it to an employee. Any
product development inventory that is not properly transferred to an employee
must be destroyed pursuant to these rules. All product development inventory
transferred to an employee counts toward the limitations in R 420.509(4) and R
420.509(5), as applicable.
(7) A licensee shall record
the transfer of product development inventory in the statewide monitoring
system.
(8) Product development
inventory may not be consumed or used on the premises of the licensee.
(9) A licensee shall not
transfer or sell inventory designated for product development to a marihuana
sales location, or to a marihuana customer, until after the inventory is tested
pursuant to R 420.304 and R 420.305, and the test results in the statewide
monitoring system indicate a passed full compliance testing.
(10) Any product development
inventory that is transferred to a marihuana sales location must be labeled in
accordance with R 420.504.
(11) A cultivator or
producer may also engage in a research study with an entity duly authorized by
the Drug Enforcement Administration to handle marihuana. A licensee’s
participation in a research study must be approved by the agency.
(12) A licensee participating
in an approved research study shall track all marihuana product involved in the
research study in the statewide monitoring system.
R 420. 511 Severability. Rescinded.
Rule 11. If any rule or
subrule of these rules, in whole or in part, is found to be invalid by a court
of competent jurisdiction, such decision will not affect the validity of the
remaining portion of these rules.
DEPARTMENT OF
LICENSING AND REGULATORY AFFAIRS
MARIJUANA
REGULATORY AGENCY
PART 8. MARIHUANA EMPLOYEES
(By authority conferred on the
executive director of the marijuana regulatory agency by section 206 of the
medical marihuana facilities licensing act, 2016 PA 281, MCL 333.27206,
sections 7 and 8 of the Michigan Regulation and Taxation of Marihuana Act, 2018
IL 1, MCL 333.27957 and 333.27958, and Executive Reorganization Order No.
2019-2, MCL 333.27001)
R 420.601 Definitions. Rescinded.
Rule 1. (1) As used in these
rules:
(a) “Acts” refers to the
medical marihuana facilities licensing act, 2016 PA 281, MCL 333.27101 to
333.27801, and the Michigan Regulation and Taxation of Marihuana Act, 2018 IL
1, MCL 333.27951 to 333.27967, when applicable.
(b) “Agency” means the
marijuana regulatory agency.
(c) “Cultivator” means both
a grower under the medical marihuana facilities licensing act and a marihuana
grower under the Michigan Regulation and Taxation of Marihuana Act.
(d) “Designated consumption
establishment” means a commercial space that is licensed by the agency and
authorized to permit adults 21 years of age and older to consume marihuana
products at the location indicated on the state license.
(e) “Employee” means,
except as otherwise provided in these rules, a person performing work or
service for compensation. “Employee” does not include individuals providing
trade or professional services who are not normally engaged in the operation of
a marihuana establishment.
(f) “Laboratory” means both
a safety compliance facility under the medical marihuana facilities licensing
act and a marihuana safety compliance facility under the Michigan Regulation
and Taxation of Marihuana Act.
(g) “Limited access area”
means a building, room, or other contiguous area of a marihuana business where
marihuana is grown, cultivated, stored, weighed, packaged, sold, or processed
for sale and that is under the control of the licensee.
(h) “Marihuana business” means
a marihuana facility under the medical marihuana
facilities licensing act or a
marihuana establishment under the Michigan Regulation and Taxation of Marihuana
Act, or both.
(i) “Marihuana customer”
means a registered qualifying patient under the medical marihuana facilities
licensing act, a registered primary caregiver under the medical marihuana
facilities licensing act, or an individual 21 years of age or older under the
Michigan Regulation and Taxation of Marihuana Act, or all 3.
(j) “Marihuana
establishment” means a marihuana grower, marihuana safety compliance facility,
marihuana processor, marihuana microbusiness, marihuana retailer, marihuana
secure transporter, marihuana designated consumption establishment, or any
other type of marihuana related business licensed by the agency under the
Michigan Regulation and Taxation of Marihuana Act.
(k) “Marihuana event
organizer” means a person licensed to apply for a temporary marihuana event
license under these rules.
(l) “Marihuana facility”
means a location at which a licensee is licensed to operate under the medical
marihuana facilities licensing act.
(m) “Marihuana product”
means marihuana or a marihuana-infused product, or both, as those terms are
defined in the acts unless otherwise provided for in these rules.
(n) “Marihuana sales
location” means a provisioning center under the medical marihuana facilities
licensing act or a marihuana retailer, marihuana microbusiness¸ or class A
marihuana microbusiness under the Michigan Regulation and Taxation of Marihuana
Act, or both.
(o) “Marihuana tracking
act” means the marihuana tracking act, 2016 PA 282, MCL 333.27901 to 333.27904.
(p) “Marihuana transporter”
means a secure transporter under the medical marihuana facilities licensing act
or a marihuana secure transporter under the Michigan Regulation and Taxation of
Marihuana Act, or both.
(q) “Medical marihuana
facilities licensing act” or “MMFLA” means the medical marihuana facilities
licensing act, 2016 PA 281, MCL 333.27101 to 333.27801.
(r) “Michigan Regulation
and Taxation of Marihuana Act” or “MRTMA” means the Michigan Regulation and
Taxation of Marihuana Act, 2018 IL 1, MCL 333.27951 to 333.27967.
(s) “Producer” means both a
processor under the medical marihuana facilities licensing act and a marihuana
processor under the Michigan Regulation and Taxation of Marihuana Act.
(t) “These rules” means the
administrative rules promulgated by the marijuana regulatory agency under the
authority of the medical marihuana facilities licensing act, the marihuana
tracking act, the Michigan Regulation and Taxation of Marihuana Act, and
Executive Reorganization Order No. 2019-2, MCL 333.27001.
(u) “Temporary marihuana
event license” means a state license held by a marihuana event organizer under
the Michigan Regulation and Taxation of Marihuana Act, for an event where the
onsite sale or consumption of marihuana products, or both, are authorized at
the location indicated on the state license.
(2) Terms defined in the
acts have the same meanings when used in these rules unless otherwise
indicated.
R 420.602 Employees; requirements.
Rule 2602. (1) A
licensee shall do all of the following:
(a) conductConduct
a criminal history background check on any a prospective employee
before hiring that individual. A licensee shalland keep records
of the results of the criminal history background checks for the duration of
the employee’s employment with the licensee. A licensee shall record
confirmation of criminal history background checks and make the confirmation
available for inspection upon request by the agency.
(2) A licensee shall comply
with all of the following:
(ab) Have a
policy in place that requires employees to report any new or pending
criminal charges or convictions. If an employee is charged with or convicted of
a controlled substance-related felony or any other felony, the licensee shall
immediately report the charge or conviction to the agency. If an employee of
a licensee under the MRTMA is convicted of an offense involving distribution of
a controlled substance to a minor, the licensee shall immediately report the
conviction to the agency.
(bc) Enter in
the statewide monitoring system an employee’s information and level of
statewide monitoring system access within 7 business days of hiring for the
system to assign an employee identification number. The licensee shall update
in the statewide monitoring system employee information and changes in status
or access within 7 business daysScreen prospective employees against a
list of excluded individuals maintained by the agency under R 420.806c.
(c) Remove an employee’s
access and permissions to the marihuana business and
the statewide monitoring system within 7 business days after the employee’s
employment with the licensee is terminated.
(d) Train employees in
accordance with an employee training manual. Copies of this manual must be
maintained and be made available to the agency upon request. The employee
training manual must include, but is not limited to, all of the following:
(i) Employee safety
procedures.
(ii) Employee guidelines.
(iii) Security protocol.
(iv) Educational training,
including, but not limited to, marihuana product information; dosage and
purchasing limits, if applicable; and educational materials.
(e) A marihuana business
under the MRTMA that sells or transfers marihuana to an individual 21 years of
age or older shall include in the employee training manual a responsible
operations plan. Copies of this plan must be maintained and be available to
the agency upon request. A responsible operations plan must include a
detailed explanation of how employees will monitor and prevent all of the
following:
(2) A licensee shall create and maintain an employee training manual that includes all of the following:
(a) Information and instructions necessary to ensure employees comply with the requirements of the acts and these rules.
(b) If the licensee is a marihuana retailer, marihuana microbusiness, or class A marihuana microbusiness, a responsible operations plan that includes a detailed explanation of how employees will monitor and prevent all of the following:
(i) Over-intoxication.
(ii) Underage access to the establishment.
(iii) The illegal sale or
distribution of marihuana or marihuana products within the
establishment.
(iv) Any potential
criminal activity on the premises, as applicable.
(fc) Establish
pointPoint of sale or transfer procedures for employees at marihuana
sales locations performing any transfers or sales to marihuana
customers. Copies of these procedures must be maintained and be made
available to the agency upon request. The point of sale or transfer
procedures must include, but are not limited to, all of the following:
(i) Training in dosage.
(ii) Marihuana product
informationInformation about marihuana.
(iii) Health or educational materials.
(iv) Point of sale training.
(v) Purchasing limits.
(vi) Cannabidiol (CBD)
and tetrahydrocannabinol (THC) information.
(vii) Serving size.
(viii) Consumption
information, including any warnings.
(g) Screen prospective
employees against a list of excluded employees maintained by the agency in
accordance with R 420.808a(6).
(h) Ensure that employees
handle marihuana product in compliance with Current Good Manufacturing
Practice, Hazard Analysis, and Risk Based Preventative Controls for Human Food,
21 CFR part 1107, as specified in these rules.
(d) Training specifically on how to comply with the requirements of R 420.221.
(i)(4) When a
registered primary caregiver is hired as an employee of a grower, processor, or
secure transporter licensed under the MMFLA, the licensee shall ensure
the individual withdraws, the individual'semployee withdraws their
registration as a registered primary caregiver in a manner established by
the agencywithin 5 days after being hired.
(j)(5) A
licensee under the MRMTA shall not do either of the following:
(a) allowAllow
a person under less than 21 years of age to volunteer or work for
the marihuana establishment pursuant tounder section 11 of the
MRTMA, MCL 333.27961.
(kb) A
licensee under the MRTMA shall not employEmploy anyan individual
who has been convicted of an offense involving distribution of a controlled
substance to a minor.
(3) If an individual is
present at a marihuana business or in a marihuana transporter vehicle who is
not identified as a licensee or an employee of the licensee in the statewide
monitoring system or is in violation of the acts or these rules, the agency may
take any action permitted under the acts and these rules. This subrule does not
apply to authorized escorted visitors at a marihuana business.
(4) Employee records are
subject to inspection or examination by the agency to determine compliance with
the acts and these rules.
(6) Trade or professional
services providers not normally engaged in the operation of a marihuana
business, except for those individuals required to have employee credentials
under this rule, must be reasonably monitored, logged in as a visitor, and
escorted through any limited-access areas.
(7) Nothing in this rule
prohibits a licensee from allowing visitors into the marihuana business., A
licensee shall ensure that visitors are reasonably monitored, logged in as a
visitor, and escorted through any limited-access areas. Visitors
that are not employees or individuals providing trade or professional services
are prohibited where hazardous materials are used, handled, or stored in the
marihuana business.
R 420.602a Prohibitions Employees;
certifications; cultivators; marihuana microbusinesses;
class A marihuana microbusinesses.
Rule 2a602a. (1)
An employee of a cultivator may not also be employed by a marihuana transporter
or a laboratory.
(2) An employee of a
producer may not also be employed by a marihuana transporter or a laboratory.
(3) An employee of a
marihuana sales location may not also be employed by a marihuana transporter or
a laboratory.
(4) An employee of a
marihuana transporter may not also be employed by a cultivator, producer,
marihuana sales location, or laboratory.
(5) An employee of a
laboratory may not also be employed by a cultivator, producer, marihuana sales
location, or marihuana transporter.
(6) An employee of a
marihuana microbusiness or a class A marihuana microbusiness may not also be
employed by a laboratory or a marihuana transporter. (1) A cultivator,
marihuana microbusiness, and class A marihuana microbusiness shall employ at
least 1 individual who has obtained pesticide applicator certification from the
department of agriculture and rural development.
(2) A cultivator, microbusiness, and class A microbusiness shall comply with the requirements of this rule by whichever of the following occurs later:
(a) 1 year after the effective date of this rule.
(b) 1 year after being issued a license.
R 420. 603 Severability Employment
prohibitions.
Rule 603. If any rule
or subrule of these rules, in whole or in part, is found to be invalid by a
court of competent jurisdiction, such decision will not affect the validity of
the remaining portion of these rules. (1) An employee of a
cultivator shall not also be employed by a marihuana transporter or a
laboratory.
(2) An employee of a producer shall not also be employed by a marihuana transporter or a laboratory.
(3) An employee of a marihuana sales location shall not also be employed by a marihuana transporter or a laboratory.
(4) An employee of a marihuana transporter shall not also be employed by a cultivator, producer, marihuana sales location, or laboratory.
(5) An employee of a laboratory shall not also be employed by a cultivator, producer, marihuana sales location, or marihuana transporter.
(6) An employee of a marihuana microbusiness or a class A marihuana microbusiness shall not also be employed by a laboratory or a marihuana transporter.
R 420.604 Hiring employees with criminal charges or convictions.
Rule 604. (1) A licensee under the MMFLA shall not hire an individual who has been charged or convicted within the past 10 years of a controlled substance-related felony unless the licensee receives approval from the agency.
(2) A licensee seeking approval under subrule (1) of this rule shall submit all of the following to the agency:
(a) A request to hire the prospective employee in a manner prescribed by the agency.
(b) A copy of the arrest report or reports that resulted in the prospective employee’s pending charge or conviction.
(c) A copy of the prospective employee’s pending charge or conviction documents.
(d) A written statement from the licensee that includes all of the following:
(i) The prospective employee’s proposed job title.
(ii) A description of the prospective employee’s job duties.
(iii) An explanation of the steps the licensee has taken to ensure the conduct that resulted in the prospective employee’s pending charge or conviction will not jeopardize the facility’s operations if the conduct were to reoccur. If the prospective employee’s conduct that resulted in the pending charge or conviction is unrelated to the job duties that the prospective employee will be performing, include a statement to that effect.
(2) If an existing employee is acquired by a new licensee during a business purchase, a new
background check and approval are not required if the new licensee has the records to show the background check was completed.
(3) The agency shall review the required documents, make a determination regarding the prospective employee’s employment, and notify the licensee of its determination.
DEPARTMENT OF
LICENSING AND REGULATORY AFFAIRS
MARIJUANA
REGULATORY AGENCY
PART 9. MARIHUANA HEARINGS
(By authority conferred on the
executive director of the marijuana regulatory agency by section 206 of the
medical marihuana facilities licensing act, 2016 PA 281, MCL 333.27206,
sections 7 and 8 of the Michigan Regulation and Taxation of Marihuana Act, 2018
IL 1, MCL 333.27957 and 333.27958, and Executive Reorganization Order No.
2019-2, MCL 333.27001)
R 420.701 Definitions.
Rescinded.
Rule 1.
(1) As used in these rules:
(a)
“Acts” refers to the medical marihuana facilities licensing act, 2016 PA 281,
MCL 333.27101 to 333.27801, and the Michigan Regulation and Taxation of
Marihuana Act, 2018 IL 1, MCL 333.27951 to 333.27967, when applicable.
(b)
“Administrative procedures act” means the administrative procedures act of
1969, 1969 PA 306, MCL 24.201 to 24.328.
(c)
“Agency” means the marijuana regulatory agency.
(d)
“Contested case hearing” means an administrative hearing conducted by an
administrative law judge within the Michigan office of administrative hearings
and rules on behalf of the agency in accordance with the acts and these rules.
(e)
“MAHS general hearing rules” means the administrative hearing rules set forth
in R 792.10101 to R 792.10137 of the Michigan administrative code.
(f)
“Marihuana business” means a marihuana facility under the medical marihuana
facilities licensing act or a marihuana establishment under the Michigan
Regulation and Taxation of Marihuana Act, or both.
(g) “Marihuana
establishment” means a marihuana grower, marihuana safety compliance facility,
marihuana processor, marihuana microbusiness, marihuana retailer, marihuana
secure transporter, marihuana designated consumption establishment, or any
other type of marihuana-related business licensed by the agency under the
Michigan Regulation and Taxation of Marihuana Act.
(h) “Marihuana facility”
means a location at which a licensee is licensed to operate under the medical
marihuana facilities licensing act.
(i)
“Marihuana license” means a state operating license issued under the medical
marihuana facilities licensing act or a state license issued under the Michigan
Regulation and Taxation of Marihuana aAct, or both.
(j) “Marihuana tracking act”
means the marihuana tracking act, 2016 PA 282, MCL 333.27901 to 333.27904.
(k) “Medical marihuana
facilities licensing act” or “MMFLA” means the medical marihuana facilities
licensing act, 2016 PA 281, MCL 333.27101 to 333.27801.
(l) “Michigan Regulation and
Taxation of Marihuana Act” or “MRTMA” means the Michigan Regulation and
Taxation of Marihuana Act, 2018 IL 1, MCL 333.27951 to 333.27967.
(m)
“MOAHR” means the Michigan office of administrative hearings and rules within
the department of licensing and regulatory affairs.
(n)
“Public investigative hearing” means a hearing in which an applicant has an
opportunity to present testimony and evidence to establish eligibility for a
marihuana license.
(o)
“These rules” means the administrative rules promulgated by the agency under
the authority of the medical marihuana facilities licensing act, the marihuana
tracking act, the Michigan Regulation and Taxation of Marihuana Act, and
Executive Reorganization Order No. 2019-2, MCL 333.27001.
(2) Terms defined in the
acts have the same meanings when used in these rules unless otherwise
indicated.
R 420.702 Hearing procedures; scope and construction of rules.
Rule 2702. (1)
These rules apply to hearings under the jurisdiction of the agency involving 1
or more of the following:
(a) The denial of a marihuana license.
(b) Formal complaints filed by the agency against a license.
(c) A complaint by a licensee.
(d) The denial of the
renewalnonrenewal of a marihuana license.
(e) The denial of an amendment application.
(2) These rules are
construed to secure a fair, efficient, and impartial determination of the
issues presented in a manner consistent with due process.
(32) If the rules
do not address a specific procedure, the MAHS general hearing rules, the
Michigan court rules, and the contested case provisions of sections 71 to 87 of
the administrative procedures act, MCL 24.271 to 24.287, the MOAHR
administrative hearing rules apply.
R 420.703 Public investigative hearing.
Rule 3703. (1)
An applicant that is denied a marihuana license by the agency may request a
public investigative hearing in writing within 21 days of after service
of notice of the denial.
(2) After the agency receives notice
of an applicant’s request for a public investigative hearinga request
for a hearing under subrule (1) of this rule, the agency mustshall
provide an opportunity for this hearing at which the applicant may present testimony
and evidence to establish eligibility and suitability for a
marihuana license.
(3) The applicant must be
given reasonable notice of the public investigative hearing in writing.
(4) Not less than 2 weeks
before the hearing, the agency shall post notice of the public investigative
hearing at its business office in a prominent place that is open and visible to
the public. Once the hearing is scheduled, a notice of the public
investigative hearing is served on the applicant at the applicant’s address of
record on file with the agency.
(54) The agency,
or 1 or morean administrative law judgesjudge
designated and authorized by the agency, shall conduct and preside over
the public investigative hearing. and do all of the following:
(a) Administer oaths or
affirmations to witnesses called to testify at the hearing.
(b) Receive evidence in
the form of testimony and exhibits.
(c) Establish and regulate
the order of presentation and course of the public investigative hearing; set
the time and place for continued hearings; and fix the time for filing written
arguments, legal briefs, and other legal documents.
(d) Accept and consider
relevant written and oral stipulations of fact and law that are made part of
the hearing record.
(65) UponOn
timely request of the applicant or the agency in accordance with the
Michigan court rules, the agency or the agency’s designated administrative
law judge may issue subpoenas for the attendance of witnesses and subpoenas
duces tecum for the production of books, ledgers, records, memoranda,
electronically retrievable data, and other pertinent documents and issue
subpoenas for witnesses to appear and testify as appropriate to exercise
and discharge the agency’s powers and duties under the acts.
(76) During the
public investigative hearing, the applicant and the agency must be given a full
opportunity to present witnesses, cross-examine witnesses, and present all
relevant evidence regarding the applicant’s eligibility and suitability for
licensure.
(87) The
applicant shall at all times havehas the burden of establishing,
by clear and convincing evidence, its eligibility and suitability for licensure
under the acts and these rules.
(9) The agency shall record
the public investigative hearing stenographically or by other means, to ensure
preservation of an accurate record of the hearing.
(108) Following
the public investigative hearing, the executive director of the agency
shall affirm, reverse, or modify in whole or in part the denial of athe
marihuana license.
(119) The agency’s
decision to affirm, reverse, or modify in whole or in part the denial of
a marihuana licensemade under subrule (8) of this rule must beis
based on the whole record before the agency and is not be limited
to testimony and evidence submitted at the public investigative hearing.
(1210) The agency’s
decision to affirm, reverse, or modify in whole or in part the denial of
a marihuana licensemade under subrule (8) of this rule must be
reduced to writing and served uponon the applicant and agency
within a reasonable time.
R 420.704 Hearing on disciplinary actions.
Rule 4704. (1) A
licensee who has been notified of a marihuana license violation, or of the
agency’s intent to suspend, revoke, restrict, or refuse to renew a marihuana
license or impose a fine, may be given an opportunity to show compliance with
the requirements before the agency takinges action as prescribed by these
rules.
(2) A licensee aggrieved by
an action of the agency to suspend, revoke, restrict, or refuse to renew a
marihuana license, or to impose a fine,that is served with a formal
complaint or notice of nonrenewal of a license may request a contested case
hearing in writing within 21 days after service of notice of the intended
action.
(32) UponOn
receipt of a timely request, the agency shall provide the licensee an
opportunity for a contested case hearing in accordance with sections 71 to 87
of the administrative procedures act, MCL 24.271 to 24.287, and the MAHS
general hearing rulesMOAHR administrative hearing rules.
(4) The contested case
hearing must be conducted by an administrative law judge within the MOAHR.
(53) UponOn
timely request of the licensee or the agency in accordance with the Michigan
court rules, an assigned administrative law judge may issue subpoenas
for the attendance of witnesses and subpoenas duces tecum for the
production of books, ledgers, records, memoranda, electronically retrievable
data, and other pertinent documents, and administer oaths and affirmations
to witnesses as appropriate to exercise and discharge the agency’s powers
and duties under the acts and these rules.
(64) The agency
has the burden of proving, by a preponderance of the evidence, that sufficient
grounds exist for the intended action to suspend, revoke, restrict, or refuse
to renew a marihuana license, or to impose a finethe licensee violated
the acts or these rules as alleged in the formal complaint.
(5) Except as otherwise provided for by statute or rule or by leave of the administrative law judge, discovery in a contested case is not allowed.
R 420.704a Hearing on exclusion
of individuals or employees.
Rule 4a704a. (1)
An individual who has been notified of the agency’s intent to exclude him or
her from being employed by or being a supplemental applicant of a marihuana
businessdo any of the following may request a hearing in writing
within 21 days ofafter service: of the notice of intent
to exclude.
(a) Exclude the individual from being employed by a marihuana business.
(b) Exclude the individual from obtaining a marihuana license.
(c) Exclude the individual from being a supplemental applicant for a marihuana license.
(2) UponOn receipt
of a timely request, the agency shall provide the individual an opportunity for
a contested case hearing pursuant tounder sections 71 to 87 of
the administrative procedures act, MCL 24.271 to 24.287, and the MAHS
general hearing rulesMOAHR administrative hearing rules.
(3) The contested case
hearing must be conducted by an administrative law judge within the MOAHR.
(43) UponOn
timely request of the licenseeindividual or the agency
pursuant to the Michigan court rules, an assigned administrative law judge
may issue subpoenas for the attendance of witnesses and subpoenas duces
tecum for the production of books, ledgers, records, memoranda, electronically
retrievable data, and other pertinent documents, and issue subpoenas for
witnesses to appear and testify as appropriate to exercise and discharge
the agency’s powers and duties under the acts and these rules.
(54) The agency
has the burden of proving, by a preponderance of the evidence, that sufficient
grounds exist for the intended action to exclude an individual from being
employed by or being a supplemental applicant of a marihuana businessexcluding
the individual from being employed by a marihuana business, obtaining a
marihuana license, or being a supplemental applicant for a marihuana license.
R 420.705 Hearing on Summary
suspension summary suspensions.
Rule 5705. (1) If
the agency summarily suspends a marihuana license without notice or hearing
upon a determination that the safety or health of patrons or employees is
jeopardized by continuing the marihuana business’s operation, a
post-suspension hearing must be heldcommenced promptly to
determine if the suspension should remain in effect, in accordance with section
92 of the administrative procedures act, MCL 24.292, and the MAHS
general hearing MOAHR administrative hearing rules.
(2) On timely request of the individual or the agency, the agency or an assigned administrative law judge may issue subpoenas for the attendance of witnesses and subpoenas duces tecum for the production of books, ledgers, records, memoranda, electronically retrievable data, and other pertinent documents as appropriate to exercise and discharge the agency’s powers and duties under the acts.
(23) At the
post-suspension hearing, the agency has the burden of proving by a
preponderance of the evidence that the summary suspension should remain in
effect because the safety or health of patrons or employeespublic
health, safety, or welfare is jeopardized by continuing the marihuana
business’s operation.
(34) Immediately
after the post-suspension hearing, the administrative law judge shall issue a
written order granting or denying dissolution of the summary suspension.
(45) If the
licensee fails to appear at the post-suspension hearing, the administrative law
judge shall find that the safety or health of patrons or employees is
jeopardized by continuing the marihuana business’s operation and continue the
order of summary suspension.
(56) The record
created at the post-suspension hearing becomes a part of the record at any
subsequent hearing in the contested case.
R 420.706 Complaint by licenseea
marihuana facility.
Rule 6706. (1) Pursuant
to the MMFLA and these rules, a licenseeA marihuana facility under the
MMFLA may file a written complaint with the agency regarding any investigative
procedures of this state that he or shethe licensee believes to
beare unnecessarily disruptive of the marihuana facility operations,
as provided in section 302 of the actMMFLA, MCL 333.27302.
(2) The agency may delegate
authority to an administrative law judge to hear a licensee’smarihuana
facility’s complaint as a contested case in accordance with sections 71 to
79 of the administrative procedures act, MCL 24.271 to 24.279, and the MAHS
general hearing rules MOAHR administrative hearing rules.
(3) As the complaining party, a
licenseemarihuana facility has the burden of proving, by a
preponderance of the evidence, that the investigative procedures of the
agency unnecessarily disrupted its marihuana facility operations.
R 420.707 Proposal for decision.
Rule 7707.
Following an opportunity for a public investigative hearing or contested case
hearing and the closure of the record after submission of briefs, if
any, the administrative law judge shall prepare and serve upon the parties a
proposal for decision containing proposed findings of fact and conclusions of
law, in accordance with section 81 of the APA, MCL 24.281administrative
procedures act, MCL 24.281.
R 420.708 Final order.
Rule 8708. (1) The
agencyexecutive director or the executive director’s designee shall
consider the entire public investigative or contested case record and may
affirm, reverse, or modify all or part of the proposal for decision.
(2) The agency’s decision must
be reduced to writing and served uponon the licensee within a
reasonable time.
(3) The review decision or
order of the agency following an opportunity for a hearing is deemed to
be the final agency decision or order for purposes of judicial review under
chapter 6 of the APA, MCL 24.301 to 24.306administrative procedures
act, MCL 24.301 to 24.306.
R 420.709 Severability Declaratory
rulings.
Rule 9709. If
any rule or subrule of these rules, in whole or in part, is found to be invalid
by a court of competent jurisdiction, such decision will not affect the
validity of the remaining portion of these rules. (1) A person may
request a declaratory ruling as to the applicability to an actual state of
facts of a statute, rule, final order, or decision administered, promulgated,
or issued by the agency. A request must not relate to a hypothetical fact
situation.
(2) A request for a declaratory ruling must be made on a form provided by the agency and submitted to the mailing address or email address on the form.
(3) Within 60 days after receipt of a request, the agency shall issue a written notification stating whether or not a declaratory ruling will be issued.
(4) If the agency determines that it will issue a declaratory ruling, it shall do so within 90 days after the notification date specified in subrule (3) of this rule, unless the agency notifies the interested person in writing of the need for additional time.
(5) The agency may do any of the following:
(a) Request more information from the person that requested the declaratory ruling.
(b) Request information from other interested parties.
(c) Request information from experts outside the agency.
(d) Request oral or written arguments from interested parties.
(e) Hold a hearing on proper notice to all interested parties.
(6) If the agency requests more information from the person that requested the declaratory ruling, the agency must either deny or grant the request within 60 calendar days after receiving satisfactory clarification of facts from the requesting person or after the date the agency notifies the requesting person of the need for additional time.
(7) The agency may deny a request for a declaratory ruling for any of the following and must describe the reason or reasons for denial of the request in a written notification to the person that requested the declaratory ruling:
(a) The interested person fails to submit a request in the manner prescribed by the agency.
(b) The state of facts is incomplete or inaccurate.
(c) The facts or circumstances relate to a changing situation.
(d) The ruling would not be in the public interest or in furtherance of statutory objectives.
(e) Another reason described by the agency.
(8) A denial or adverse decision of a declaratory ruling does not entitle a person to a contested case hearing.
(9) Requests regarding enforcement issues are not a proper subject for a declaratory ruling.
(10) The agency may require that a contested case hearing for a pending case take place instead of issuing a declaratory ruling.
(11) A declaratory ruling issued by the agency must be in writing and contain all of the following:
(a) The specific facts on which the declaratory ruling is based.
(b) The legal authority on which the declaratory ruling is based.
(c) The ruling itself.
(d) A statement that the declaratory ruling is limited to the specific facts presented and to the statute, rule, final decision, or order identified by the interested person or another statute, rule, final decision, or order identified by the agency.
(e) A statement that the declaratory ruling is binding on the agency and the interested person unless the declaratory ruling is altered or set aside by a court.
(f) A statement that the agency may not retroactively change the declaratory ruling but may prospectively do so in its discretion.
(12) Nothing in this rule is intended to limit or restrict the agency’s ability to respond to questions or inquiries from licensees or the general public, but an agency response to such questions or inquiries is not binding on the agency.
DEPARTMENT OF
LICENSING AND REGULATORY AFFAIRS
MARIJUANA
REGULATORY AGENCY
MARIHUANA
DISCIPLINARY PROCEEDINGSPART 10. ENFORCEMENT, PENALTIES, AND
DISCIPLINARY PROCEEDINGS
(By authority conferred on the
executive director of the marijuana regulatory agency by section 206 of the
medical marihuana facilities licensing act, 2016 PA 281, MCL 333.27206,
sections 7 and 8 of the Michigan Regulation and Taxation of Marihuana Act, 2018
IL 1, MCL 333.27957 and 333.27958, and Executive Reorganization Order No.
2019-2, MCL 333.27001)
R 420.801 Definitions Inspections;
investigations; audits.
Rule 1801. (1) As used
in these rules:
(a) “Acts” refers to the medical
marihuana facilities licensing act, 2016 PA 281, MCL 333.27101 to 333.27801,
and the Michigan Regulation and Taxation of Marihuana Act, 2018 IL 1, MCL
333.27951 to 333.27967, when applicable.
(b) “Administrative hold” means a
status given to marihuana product by the agency during an investigation into
alleged violations of the acts and these rules. This status includes no sale
or transfer of the marihuana product until the hold is lifted.
(c) “Administrative procedures
act” means the administrative procedures act of 1969, 1969 PA 306, MCL 24.201
to 24.328.
(d) “Agency” means the marijuana
regulatory agency.
(e) “Another party” or “other
party” means an individual or company with which a licensee contracts to use
the individual or company’s intellectual property or to utilize management or
other services provided by the individual or company.
(f) “Bureau of fire services” or
“BFS” means the bureau of fire services in the department of licensing and
regulatory affairs.
(g) “Contested case hearing”
means an administrative hearing conducted by an administrative law judge within
the Michigan office of administrative hearings and rules on behalf of the
agency pursuant to the acts and these rules.
(h) “Employee” means a person
performing work or service for compensation. “Employee” does not include a
person providing trade or professional services who is not normally engaged in
the operation of a marihuana business.
(i) “Licensing agreement” means
any understanding or contract concerning the licensing of intellectual property
related to marihuana products between a licensee and another party.
(j) “Management agreement” means
any understanding or contract between a licensee and another party for the
provision of management or other services that would allow the other party to
exercise control over or participate in the management of the licensee or to
receive more than 10% of the gross or net profit from the licensee during any
full or partial calendar or fiscal year. A management
agreement does not include an agreement for the reasonable payment of rent on a
fixed basis under a bona fide lease or rental obligation unless the person
exercises control over or participates in the management of the marihuana
business.
(k) “Marihuana business” means
both a marihuana facility under the medical marihuana facilities licensing act,
or a marihuana establishment under the Michigan Regulation and Taxation of
Marihuana Act, or both.
(l) “Marihuana business location
plan” means a marihuana facility plan under the medical marihuana facilities
licensing act or a marihuana establishment plan under the Michigan Regulation
and Taxation of Marihuana Act, or both.
(m) “Marihuana license” means a
state operating license issued under the medical marihuana facilities licensing
act or a state license issued under the Michigan Regulation and Taxation of Marihuana
Act, or both.
(n) “Marihuana tracking act”
means the marihuana tracking act, 2016 PA 282, MCL 333.27901 to 333.27904.
(o) “Medical marihuana facilities
licensing act” or “MMFLA” means the medical marihuana facilities licensing act,
2016 PA 281, MCL 333.27101 to 333.27801.
(p) “Michigan Medical Marihuana
Act” means the Michigan Medical Marihuana Act, 2008 IL 1, MCL 333.26421 to
333.26430.
(q) “Michigan Regulation and
Taxation of Marihuana Act” or “MRTMA” means the Michigan Regulation and
Taxation of Marihuana Act, 2018 IL 1, MCL 333.27951 to 333.27967.
(r) “Parties” means a licensee
and another party pursuant to a licensing agreement or management agreement.
(s) “These rules” means the
administrative rules promulgated by the agency under the authority of the
medical marihuana facilities licensing act, the marihuana tracking act, the
Michigan Regulation and Taxation of Marihuana Act, and Executive Reorganization
Order No. 2019-2, MCL 333.27001.
(2) Terms defined in the acts have
the same meanings when used in these rules unless otherwise indicated. (1) The agency may
do all of the following:
(a) Inspect a marihuana business or proposed marihuana business to ensure compliance with the acts and these rules.
(b) Inspect the vehicles used by a marihuana transporter.
(c) Conduct investigations of applicants, licensees, marihuana businesses, proposed marihuana businesses, and employees of marihuana businesses to ensure compliance with the acts and these rules or to determine if a licensee or employee of a marihuana business has violated the acts or these rules.
(d) Conduct an audit of a licensee’s records.
(e) Access, inspect, and examine a licensee’s records.
(2) A licensee shall provide all records required to be maintained under the acts or these rules to the agency on request.
(3) If a licensee refuses to cooperate with an inspection, investigation, or an audit, the agency may impound, seize, assume physical control of, or summarily remove records from a marihuana business or proposed marihuana business.
(4) As used in this rule, “records” means books, ledgers, documents, writings, photocopies, correspondence, electronic storage media, electronically stored records, video surveillance recordings, money receptacles, equipment in which records are stored, including data or information in the statewide monitoring system, or other media or devices that are used for recording information.
R 420.802 Notification
and reporting Agency-required testing.
Rule 2802. (1)
Licensees have a continuing duty to provide the agency with up-to-date contact
information and shall notify the agency in writing of any changes to the
mailing addresses, phone numbers, electronic mail addresses, and other contact
information they provide the agency.
(2) Licensees shall report to the
agency any changes to the marihuana business operations that are required in
the acts and these rules, as applicable.
(3) Licensees shall report to the
agency any proposed material changes to the marihuana business before making a
material change. A proposed material change is any action that would result in
alterations or changes being made to the marihuana business to effectuate the
desired outcome of a material change. Material changes, include, but are not
limited to, the following:
(a) Change in owners, officers,
members, or managers.
(b) Change of processing
machinery or equipment.
(c) The addition or removal of a
person named in the application or disclosed.
(d) Change in entity name.
(e) Any attempted transfer,
sale, or other conveyance of an interest in a marihuana license.
(f) Any change or modification
to the marihuana business before or after licensure that was not preinspected,
inspected, or part of the marihuana business location plan or final inspection,
including, but not limited to, all of the following:
(i) Operational or method
changes requiring inspection under these rules.
(ii) Additions or reductions in
equipment or processes.
(iii) Increase or decrease in
the size or capacity of the marihuana business.
(iv) Alterations of ingress or
egress.
(v) Changes that impact
security, fire safety, and building safety.
(4) A licensee shall notify the
agency within 3 business days of becoming aware or within 3 business days of
when the licensee should have been aware of any of the following:
(a) Criminal convictions,
charges, or civil judgments against a licensee in this state or any other
state, federal, or foreign jurisdiction.
(b) Regulatory disciplinary
action taken or determined against a licensee by this state or any other state,
federal, or foreign jurisdiction, including any pending action.
(c) Action by another party in
violation of the acts or these rules.
(d) Action by an employee in
violation of the acts or these rules.
(5) The licensee shall notify the
agency within 10 business days of the initiation or conclusion of any new
judgments, lawsuits, legal proceedings, charges, or government investigations,
whether initiated, pending, or concluded, that involve the licensee.
(6) The licensee shall notify the
agency within 10 business days of receiving notification of an alleged
violation of an ordinance or a zoning regulation adopted pursuant to section
205 of the MMFLA, MCL 333.27205, or section 6 of the MRTMA, MCL 333.27956,
committed by the licensee, but only if the violation relates to activities
licensed under the acts, the Michigan Medical Marihuana Act, and these rules.
(7) The licensee shall notify the
agency within 10 business days of amending or terminating a licensing or
management agreement that constitutes a material change to the marijuana
business.
(9) The licensee shall notify the
agency when an employee has been disciplined or removed from his or her
position for misconduct related to marihuana sales or transfers.
(10) The licensee shall notify
the agency and the BFS within 1 business day following the occurrence of an
unwanted fire.
(11) Failure to timely provide
notifications or reports to the agency pursuant to this rule may result in
sanctions or fines, or both. (1) The agency may require a
licensee to have marihuana located at the licensee’s marihuana business tested
or retested by a laboratory or by the agency for 1 or more of the tests
required under part 5 of these rules.
(2) The licensee that cultivated, produced, or possesses the marihuana shall pay for the cost of tests required under this rule, as directed by the agency.
R 420.803 Changes to licensed
marihuana business Administrative holds.
Rule 3803. (1) Any
change or modification to the marihuana business after licensure is governed by
the standards and procedures set forth in these rules and any regulations
adopted pursuant to the acts. Any material change or modification to the
marihuana business must be approved by the agency before the change or
modification is made.
(2) Any change of a location of a
marihuana business after licensure requires notification to the agency prior to
the change of location, must be approved by the agency, requires a new
marihuana license application, and may include, but is not limited to, all of
the following:
(a) Additional applications
fees.
(b) Additional inspections by
the agency or BFS.
(c) Initial licensure fees or
regulatory assessment, as applicable, or both. (1) The agency may
place marihuana on administrative hold.
(2) If marihuana is placed on administrative hold, a licensee shall not sell or transfer the marihuana to another licensee, an employee, a marihuana customer, or another person, or dispose of the marihuana without first obtaining written approval from the agency.
(3) The agency may require a licensee to sequester untagged marihuana if the source of the marihuana cannot be determined or it is not properly identified and tracked in the statewide monitoring system. The marihuana must be sequestered in a location within the marihuana business that is separated from other marihuana and that is under video surveillance at all times.
R 420.804 Notifications of
diversion, theft, loss, or criminal activity Recalls.
Rule 4804. (1)
Licensees shall notify the agency and local law enforcement authorities within
24 hours of becoming aware of, or within 24 hours of when the licensee should
have been aware of, the theft or loss of any marihuana product or criminal
activity at the marihuana business.
(2) Failure to notify as
required under subrule (1) of this rule may result in sanctions or fines, or
both. (1) The agency may recall marihuana if it determines any of the
following:
(a) The marihuana contains a physical, biological, chemical, or allergenic substance that is not a part of the record of formulation.
(b) The marihuana is adulterated, corrupted, debased, or made impure by the addition of a foreign or inferior substance.
(c) If the testing required in part 5 of these rules was not performed or was performed incorrectly.
(d) The marihuana contains an allergenic substance that is not listed on the label.
(2) If marihuana is recalled, a licensee shall not do any of the following without obtaining written approval from the agency:
(a) Produce the marihuana product.
(b) Test the marihuana product.
(c) Sell or transfer the marihuana to another licensee, an employee, a marihuana customer, or another person, or dispose of the marihuana without first obtaining written approval from the agency.
(3) The agency shall send a written notification to a licensee that cultivated, produced, or possesses marihuana if the agency recalls marihuana under subrule (1) of this rule. A licensee that receives written notification shall immediately do all of the following, as applicable:
(a) Stop producing the marihuana product.
(b) Remove the marihuana from areas in a marihuana sales location accessible to the public.
(c) Sequester the marihuana in a location within the marihuana business that is separated from other marihuana and that is under video surveillance at all times.
(4) A licensee who receives a notification under subrule (3) of this rule shall respond to the agency within 1 day in a form and manner prescribed by the agency, indicating the licensee’s acknowledgement of, and intent to comply with, the requirements in this rule.
(5) If a licensee fails to comply with the requirements of this rule, and the agency determines that the safety or health of marihuana customers or employees is jeopardized by a marihuana business’s continued operation, the agency may suspend the licensee’s marihuana license without hearing or notice, under R 420.806(2).
(6) The agency may issue written approval for a licensee to sell, transfer, or test recalled marijuana during the recall to further assess or investigate the recalled marijuana product.
R 420.805 Persons subject to penalty; violations.
Rule 5805. (1) If the
agency during a physical site inspection determines violations of the
acts or these rules exist, the agency shall notify the person, applicant, or
licensee of the violation during the physical site inspection or thereafter,
and the person, applicant, or licensee may be subject to sanctions or fines, or
both.
(2) If the agency determines a
violation of the acts or these rules exists, these violations must be
documented in a format established by the agency. After a notice of violation
or fine, or both, is issued to a person, applicant, or licensee, the agency may
hold a compliance conference or a hearing if applicable as prescribed in the
acts and these rules.
(32) The agency may
forward information regarding violations of the acts or these rules or another
state or federal law to the department of state police, department of attorney
general, and the prosecutor for the jurisdiction in whichwhere the
alleged violation occurred.
(4) The agency may take action
for failure to pay any fine within the time written on the notice of violation
pursuant to the acts or these rules.
(5) The agency may take action
against a licensee for selling or transferring marihuana product that has been
placed on an administrative hold, recalled, or ordered or otherwise required to
be destroyed.
(6) A marihuana licensee may be
subject to penalties if any person required to be disclosed as an applicant
violates the acts or these rules.
(7) The agency may take action
against a licensee holding a license under the MRTMA, if notified of a violation
of a municipal ordinance pursuant to section 6 of the MRTMA, MCL 333.27956.
(8) The agency may take action
against a licensee for knowingly making misrepresentations to the agency or its
contractors during an investigation into the licensee.
(9) The attempted transfer, sale,
or other conveyance of an interest in a marihuana license without prior
approval are grounds for suspension or revocation of the marihuana license or
for other sanctions as provided in these rules.
(10) The agency may take action
against a licensee for employing an individual who has been excluded from
employment at a marihuana business under R 420.808a.
(11) The agency may take action
against a licensee for failing to remove from, or attempting to add to, the
ownership of a marihuana business an individual who has been excluded from
participation in a marihuana business under R 420.808(a).
R 420.806 Penalties.
Rule 6806. (1) A person,
applicant, or licensee found in violation ofthat violates the acts
or these rules may be subject to sanctions, including, but not limited to,
any of the following penalties:
(a) Marihuana license denialDenial
of a marihuana license.
(b) Limitations onNonrenewal
of a marihuana license.
(c) FinesSuspension of a
marihuana license.
(d) Revocation, suspension,
nonrenewal of a license, or an administrative hold on a marihuana
license.
(e) Orders to cease operationsLimitations
on a marihuana license.
(f) Denial of a marihuana license
renewalCivil fines.
(g) Orders to cease operation.
(h) Exclusion from licensure or employment at a marihuana business.
(i) Warnings.
(j) Another penalty not inconsistent with the acts or these rules.
(2) A violation of the acts,
the marihuana tracking act, or these rules may result in 1 or more of the
following:
(a) Denial, revocation, or
restriction of a marihuana license.
(b) Removal of a licensee or an
employee of the licensee from the marihuana business.
(c) Civil fines up to $10,000.00
or an amount equal to the daily gross receipts, whichever is greater, against a
licensee for each violation of the acts, a final order, or these rules.
(d) Civil fines may be assessed
for each day the licensee is not in compliance with each violation of the acts
or these rules. Assessment of a civil fine is not a bar to the investigation,
arrest, charging, or prosecution of an individual for any other violation of
the acts or these rules.
(e) Civil fines of up to
$5,000.00 may be imposed against an individual licensed under the MMFLA.
(f) A violation of any ordinance
adopted under section 205 of the MMFLA, MCL 333.27205, by a licensee holding a
license under the MMFLA may result in the possible sanctions listed in
subdivisions (a) to (e) of this subrule.
(g) A violation of any ordinance
adopted under section 6 of the MRTMA, MCL 333.27956, by a licensee holding a
license under the MRTMA may result in the possible sanctions listed in
subdivisions (a) to (d) of this subrule.
(3) A marihuana license may be
suspended without notice or hearing upon a determination that the safety or
health of patrons or employees is jeopardized by continuing a marihuana
business’ operation.
(4) A person operating without a
marihuana license shall cease operation and may be subject to sanctions,
including, but not limited to, the sanctions in subrules (1) and (2) of this
rule, and may be referred to the department of state police and department of
attorney general.
(5) The agency may impose any
other remedies, sanctions, or penalties not inconsistent with the acts or these
rules. (2)
A person operating without a marihuana license shall cease operation and may be
subject to penalties, including, but not limited to, the penalties in subrule
(1) of this rule, and may be referred to the department of state police and
department of attorney general.
(3) Assessment of a penalty under this rule is not a bar to the investigation, arrest, charging, or prosecution of an individual for another violation of the acts or these rules.
(4) The closure of a marihuana license does not terminate the agency's authority to impose penalties on the licensee.
R 420.806a Penalties; limitations on a marihuana license.
Rule 806a. (1) The agency may impose limitations, including, but not limited to, the following, on a person, applicant, or licensee found in violation of the acts or these rules:
(a) Prohibit a licensee from cultivating, processing, transporting, testing, or selling specified marihuana products.
(b) Require a licensee to implement specified procedures when cultivating, processing, transporting, testing, or selling marihuana.
(c) Prohibit a licensee from engaging in specified activities or utilizing specified processes when cultivating, processing, transporting, testing, or selling marihuana.
(d) Require a licensee to provide additional notification and reporting to the agency.
(e) Prohibit a licensee from conducting business with another licensee or person.
(2) A final order or consent agreement that imposes a limitation on a marihuana license must indicate the specific limitation imposed on the license, the duration of the limitation, and conditions that must be met before the limitation is lifted, if applicable.
R 420.806b Penalties; fines.
Rule 806b. (1) A civil fine up to $10,000.00 or an amount equal to the daily gross receipts of the marihuana business, whichever is greater, may be assessed against a licensee for each violation of the acts, a consent order, a final order, or these rules.
(2) A civil fine may be assessed for each day the licensee is in violation of the acts or these rules.
(3) A civil fine of up to $5,000.00 may be imposed against an individual licensed under the MMFLA.
R 420.806c Penalties; exclusion.
Rule 806c. (1) An individual may be placed on an exclusion list and prohibited from holding a marihuana license or being employed by a marihuana business on a finding of any of the following:
(a) The individual, while licensed or employed by a marihuana business, violated the acts or these rules and the violation could negatively impact public health, safety, and welfare.
(b) The individual was a managerial employee or otherwise responsible for overseeing the operations of a marihuana business when a violation of the acts or these rules occurred that could negatively impact public health, safety, and welfare.
(c) The individual is excluded from obtaining a marihuana license or being employed by a marihuana business in another jurisdiction in the United States and the reason for the individual’s exclusion is also grounds for exclusion under this rule.
(d) The individual has been convicted of distribution of a controlled substance to a minor.
(2) If the agency determines that an individual meets the criteria for exclusion, the agency shall notify the individual that the individual is being placed on the exclusion list. The notice must include all of the following information:
(a) The identity of the individual.
(b) A statement describing the circumstances or reasons that the individual is being placed on the exclusion list.
(c) A recommendation as to whether the exclusion is temporary or permanent.
(3) An individual who has been notified by the agency that the individual is being placed on the exclusion list may request a hearing under R 420.704a.
(4) If a hearing is not requested, the agency shall place the person on the exclusion list.
(5) If the notice of exclusion provides for a temporary exclusion, the agency shall set the term of the temporary exclusion.
(6) A marihuana business shall not employ an individual who is placed on the exclusion list.
R 420.806d Penalties; warning.
Rule 806c. (1) The agency may issue a warning to a licensee if the agency determines that the licensee violated the acts, these rules, or an order.
(2) A warning must remain in the licensee’s file for 1 year.
R 420.807 Warning Summary
suspensions.
Rule 7807. (1) The
agency may issue a warning to a licensee if the agency determines through an
investigation that the licensee violated the acts, these rules, or an order.
(2) A warning must remain in the
licensee’s file for 1 year from the date of service.
(3) A warning may be considered
in future licensing actions. Continued or repeated non-compliance or repeated
warnings for the same violation may result in issuance of a formal complaint. (1) The agency may
summarily suspend a marihuana license if the public health, safety, or welfare
requires emergency action because of any of the following:
(a) A marihuana business is in possession of marihuana for which the source cannot be determined.
(b) A marihuana business is in possession of marihuana that the agency determines was obtained from a person that does not hold a marihuana license.
(c) A licensee obstructs an agency investigation by refusing to provide the agency with records that are required to be provided under R 420.801.
(d) A licensee has engaged in other conduct that poses a risk to the public health, safety, or welfare that requires emergency action.
(2) A summary suspension is subject to the requirements of R 420.705 and section 92 of the administrative procedures act, MCL 24.292.
R 420.808 Formal complaintcomplaints.
Rule 8808. (1) The agency
may issue a formal complaint alleging violations of the acts, these rules, or
both against a licensee.
(2) The agency shall serve the formal complaint on the licensee by certified mail, return receipt requested, or in person by a representative of the agency.
(3) If the agency issues a formal
complaint against a licensee, Thethe licensee may do either
of the following:
(a) Meet with the agency toEngage
with the agency at a compliance conference and negotiate a settlement of
the matter, or demonstrate compliance prior tobefore holding a
contested case hearing, as required by section 92 of the administrative
procedures act, MCL 24.292.
(b) Proceed to a contested case hearing as set forth in these rules and section 71 of the administrative procedures act, MCL 24.271.
(4) The licensee mustshall
request a compliance conference or contested case hearing, or both,
within 2130 business days ofafter receipt of
the formal complaint. If the licensee does not respond, the agency shall
request a contested case hearing.
(5) If the licensee agrees to and
accepts the terms negotiated at thea compliance conference,
the agency shall submit a proposed consent order and stipulation to the
executive director of the agency for review and approval.
(6) If the executive director approves
the consent order and stipulation is approved, the agency shall issue a
consentand publish the order. If the consent order and stipulation
isare not approved, a compliance conference or a contested
case hearing must be scheduled. The consent order must be publishedthe
executive director may provide a counteroffer, or the agency may renegotiate an
agreed settlement with the licensee. If the executive director rejects the
settlement offer, the matter is scheduled for a contested case hearing.
(7) The agency shall publish consent orders on its website.
(78) If a licensee does
not timely comply with the terms of a signed and fully executed consent order,
the licensee’s license is suspended until full compliance is demonstrated.
(89) If a compliance
conference is not held or does not result in a settlement of a compliance action,
a contested case hearing must be held, pursuant tounder these
rules and the administrative procedures act.
R 420.808a Exclusion. Rescinded.
Rule 8a. (1) A person may be excluded
from employment at, or participation in, a marihuana business upon a finding of
any of the following:
(a) The person, while employed
by a marihuana business, has engaged in conduct that is in violation of the
acts or these rules that could negatively impact public health, safety, and
welfare.
(b) The person is included on
any valid and current exclusion list from another jurisdiction in the United
States if the basis for the person’s inclusion on the exclusion list would also
be grounds for exclusion as set forth in this rule.
(c) The person has been
convicted of distribution of a controlled substance to a minor in any
jurisdiction.
(2) Upon a determination that a
person comes under any of the criteria for exclusion, the person may be deemed
a subject for exclusion and the agency shall file a notice of exclusion. The
notice must include all of the following information:
(a) The identity of the
subject.
(b) A factual statement
including the circumstances or reasons that the person should be placed on the
exclusion list.
(c) A recommendation as to
whether the exclusion or ejection is permanent.
(3) The notice shall also inform
the person of the availability of a hearing in compliance with R 420.704a.
(4) The notice shall be served
upon the person the agency is seeking to exclude either by personal delivery or
by certified mail, postage prepaid.
(5) If a hearing is not
requested, then the agency shall place the person on the exclusion list.
(6) If the notice of exclusion
provides for a temporary exclusion, then the agency shall set the term of the
temporary exclusion.
(a) A temporary exclusion may
not be less than 6 months.
(b) A temporary exclusion only
applies to a person excluded for criteria related to conduct.
(c) All other exclusions are
permanent.
(7) The exclusion list must be a
public record made available to licensees by the agency and must include
information deemed necessary by the agency to facilitate identification of the
person placed on the exclusion list.
(8) A person who is placed on the
exclusion list or served with a notice of exclusion is prohibited from being
employed by or participating in a marihuana business until a determination by
the agency or a court to the contrary.
(9) A marihuana business shall
exclude a person from the business that it knows or reasonably should know is
on the exclusion list.
(10) Failure by a marihuana
business to exclude a person that it knows or reasonably should know is on the
exclusion list may subject the marihuana business to disciplinary proceedings.
R 420. 809 Severability. Rescinded.
Rule 9. If any rule or
subrule of these rules, in whole or in part, is found to be invalid by a court
of competent jurisdiction, such decision will not affect the validity of the
remaining portion of these rules.
DEPARTMENT OF
LICENSING AND REGULATORY AFFAIRS
MARIJUANA
REGULATORY AGENCY
MARIHUANA
DECLARATORY RULINGS
(By authority conferred on the
executive director of the marijuana regulatory agency by section 5 of the
Michigan Medical Marihuana Act, 2008 IL 1, MCL 333.26425, section 206 of the
medical marihuana facilities licensing act, 2016 PA 281, MCL 333.27206,
sections 7 and 8 of the Michigan Regulation and Taxation of Marihuana Act, 2018
IL 1, MCL 333.27957 and 333.27958, and Executive Reorganization Order No.
2019-2, MCL 333.27001)
R 420.821 Definitions. Rescinded.
Rule 21. (1) As used in
these rules:
(a) “Acts” refers to the
medical marihuana facilities licensing act, 2016 PA 281, MCL 333.27101 to
333.27801, the Michigan Regulation and Taxation of Marihuana Act, 2018 IL 1,
MCL 333.27951 to 333.27967, the Michigan Medical Marihuana Act, 2008 IL 1, MCL
333.26421 to 333.26430, and the marihuana tracking act, 2016 PA 282, MCL
333.27901 to 333.27904, when applicable.
(b) “Agency” means the
marijuana regulatory agency.
(c) “Contested case hearing”
means an administrative hearing conducted by an administrative law judge within
the Michigan office of administrative hearings and rules on behalf of the
agency in accordance with the acts and these rules.
(d) “Marihuana tracking act”
means the marihuana tracking act, 2016 PA 282, MCL 333.27901 to 333.27904.
(e) “Medical marihuana
facilities licensing act” or “MMFLA” means the medical marihuana facilities
licensing act, 2016 PA 281, MCL 333.27101 to 333.27801.
(f) “Michigan Regulation and
Taxation of Marihuana Act” or “MRTMA” means the Michigan Regulation and
Taxation of Marihuana Act, 2018 IL 1, MCL 333.27951 to 333.27967.
(g) “These rules” means the
administrative rules promulgated by the agency under the authority of the
medical marihuana facilities licensing act, the marihuana tracking act, the
Michigan Regulation and Taxation of Marihuana Act, and Executive Reorganization
Order No. 2019-2, MCL 333.27001.
(2) Terms defined in the
acts have the same meanings when used in these rules unless otherwise
indicated.
R 420.822 Declaratory
rulings. Rescinded.
Rule 22. (1) Any interested
person may request a declaratory ruling as to the applicability to an actual
state of facts of a statute, rule, final order, or decision administered,
promulgated, or issued by the agency. A request may not relate to a
hypothetical fact situation.
(2) The request must be on a
form provided by the agency and contain all of the following information:
(a) The interested person’s
name, mailing address, email address, and telephone number.
(b) The interested person’s
interest in the matter, including assertions regarding the person’s legal
standing to request a declaratory ruling.
(c) The statute, rule, or
order to which the request applies.
(d) A complete, accurate,
and concise statement of the facts to which the statute, rule, or order may
apply.
(e) An analysis, legal
brief, or memorandum of the issues presented, including reference to any legal
authority relied upon, and the interested person’s conclusions.
(3) Within 60 calendar days
of receipt of the request, the agency shall issue a written notification
stating whether or not a declaratory ruling will be issued.
(4) If the agency has
determined that it will issue a declaratory ruling, then it shall do so within
90 calendar days of the notification date specified in subrule (3) of this
rule, unless the agency notifies the interested person in writing of the need for
additional time, and the reasons for the additional time.
(5) Before the issuance of
the declaratory ruling, the agency, in its discretion, may choose to do 1 or
more of the following:
(a) Seek consultation,
comments, or advice from legal counsel, experts within or outside the agency,
local, state, or federal governmental agencies, or any other source.
(b) Request information or
clarification from other interested parties.
(c) Advise the person
requesting the ruling that further clarification of the facts must be provided,
or that the agency requires additional time to conduct a review.
(6) If subrule (5)(c) of
this rule is invoked, the agency shall either deny or grant the request within
60 calendar days after receiving satisfactory clarification of facts from the
requesting person or from the date the agency notifies the requesting person of
the need for additional time.
(7) The agency shall issue a
declaratory ruling only in matters where all the relevant facts are stipulated
to by the requesting party and the agency. If relevant facts necessary to issue
a declaratory ruling are contested, then a declaratory ruling shall not be
issued.
(8) A denial or adverse
decision of a declaratory ruling does not entitle a person to a contested case
hearing.
(9) Requests regarding
enforcement issues are not a proper subject for a declaratory ruling.
(10) The agency may require
that a contested case hearing take place instead of issuing a declaratory
ruling.
(11) In the discretion of
the agency, a request for declaratory ruling may be denied if the interested
person fails to follow the procedure for submission set forth in this rule, if
the state of facts is incomplete or inaccurate, if the facts or circumstances
relate to a changing situation, if the ruling would not be in the public
interest or in furtherance of statutory objectives, or for any other stated
reason. The agency shall set forth the reasons for denial of the request in
its written notification to the interested person.
(12) If a declaratory ruling
is issued by the agency, it must be in writing, and contain all of the
following:
(a) The specific facts upon
which it is based.
(b) The legal authority
upon which it is based.
(c) The ruling itself.
(d) A statement that the
ruling is limited to the specific facts presented and to the statute, rule,
final decision, or order identified by the interested person or other statute,
rule, final decision, or order identified by the agency.
(e) A statement that the
ruling is binding on the agency and the interested person unless it is altered
or set aside by any court.
(f) A statement that the
agency may not retroactively change the ruling but may prospectively do so in
its discretion.
(13) Nothing in this rule
is intended to limit or restrict the agency’s ability to respond to questions
or inquiries from licensees or the general public, but any agency response to
such questions or inquiries shall not be binding on the agency.
R 420.823 Severability. Rescinded.
Rule 23. If any rule or
subrule of these rules, in whole or in part, is found to be invalid by a court
of competent jurisdiction, such decision will not affect the validity of the
remaining portion of these rules.
DEPARTMENT OF
LICENSING AND REGULATORY AFFAIRS
MARIJUANA
REGULATORY AGENCY
PART 11. INDUSTRIAL
HEMP RULES FOR MARIHUANA BUSINESSES
(By authority conferred on the
executive director of the marijuana regulatory agency by section 206 of the
medical marihuana facilities licensing Act, 2016 PA 281, MCL 333.27206,
sections 7 and 8 of the Michigan Regulation and Taxation of Marihuana Act, 2018
IL 1, MCL 333.27957 and 333.27958, and Executive Reorganization Order No.
2019-2, MCL 333.27001)
R 420.1001 Definitions.
Rule 11001. (1) As
used in these rulesthis part,:
(a) “Agency” means the
marijuana regulatory agency.
(b) “Broker” means that
term as defined in section 2 of the industrial hemp research and development
act, MCL 286.842.
(c) “Department” means the
department of licensing and regulatory affairs.
(d) “Grower” means that
term as defined in section 2 of the industrial hemp research and development
act, MCL 286.842.
(e) “Handle” means that
term as defined in section 2 of the industrial hemp research and development
act, MCL 286.842.
(f) “Industrial hemp” means
that term as defined in section 2 of the industrial hemp research and
development act, MCL 286.842.
(g) “Industrial hemp
research and development act” means the industrial hemp research and
development act, 2014 PA 547, MCL 286.841 to 286.859.
(h) “Laboratory” means a
safety compliance facility licensed under the medical marihuana facilities
licensing act or a marihuana safety compliance facility licensed under the
Michigan regulation and taxation of marihuana act, or both.
(i) “Marihuana processor”
means that term as defined in section 3 of the Michigan regulation and taxation
of marihuana act, MCL 333.27953.
(j) “Marihuana safety
compliance facility” means that term as defined in section 3 of the Michigan
regulation and taxation of marihuana act, MCL 333.27953.
(k) “Marihuana tracking
act” means the marihuana tracking act, 2016 PA 282, MCL 333.27901 to 333.27904.
(l) “Market” means that
term as defined in section 2 of the industrial hemp research and development
act, MCL 286.842.
(m) “Medical marihuana
facilities licensing act” or “MMFLA” means the medical marihuana facilities
licensing act, 2016 PA 281, MCL 333.27101 to 333.27801.
(n) “Michigan medical
marihuana act” means the Michigan Medical Marihuana Act, 2008 IL 1, MCL
333.26421 to 333.26430.
(o) “Michigan regulation
and taxation of marihuana act” or “MRTMA” means the Michigan Regulation and
Taxation of Marihuana Act, 2018 IL 1, MCL 333.27951 to 333.27967.
(p) “Process”“process”
means that term as defined in section 2 of the industrial hemp research and
development act, MCL 286.842.
(q) “Processor” means a
facility licensed to operate under section 502 of the medical marihuana
facilities licensing act, MCL 333.27502, and these rules.
(r) “Producer” means a
processor licensed under the medical marihuana facilities licensing act or a
marihuana processor licensed under the Michigan regulation and taxation of
marihuana act, or both.
(s) “Rules” means the
administrative rules promulgated by the agency under the authority of the
medical marihuana facilities licensing act, the marihuana tracking act, the
Michigan regulation and taxation of marihuana act, and Executive Reorganization
Order No. 2019-2, MCL 333.27001.
(t) “Safety compliance
facility” means a facility licensed to operate under section 505 of the medical
marihuana facilities licensing act, MCL 333.27505, and these rules.
(2) Terms defined in the
acts have the same meanings when used in these rules unless otherwise
indicated.
R 420.1002 Testing industrial hemp.
Rule 21002. (1)
A laboratory may perform tests on industrial hemp product as required under the
industrial hemp research and development act and any associated rules
promulgated by the Michigan department of agriculture and rural development.
(21) A laboratory
may perform all tests on industrial hemp required or requested inunder
the industrial hemp research and development act and any associated rules
promulgated under that act by the Michigan department of
agriculture and rural development.
(32) A laboratory
shall document the results of all testingtests performed
on industrial hemp products and shall make those records available to the
agency upon request.
(3) A laboratory
shall maintainstore industrial hemp product samples separate from
any marihuana product samples at all times.
(54) A laboratory
may obtain samples of industrial hemp for testing pursuant tounder the
industrial hemp research and development act and any associated rules
promulgated by the Michigan department of agriculture and rural
development.
(65) A laboratory
mustshall report test results as required under the industrial
hemp research and development act and any associated rules
promulgated under that act by the Michigan department of agriculture
and rural development.
(76) A laboratory
must not transfer or sell any industrial hemp product obtained for testing
to any other facility other than the licensee from whom the sample was obtainedshall
only transfer industrial hemp obtained for testing to the licensee from whom
the sample was obtained.
(8) A laboratory shall enter
all transactions, current inventory, and other information into the statewide
monitoring system as required by the industrial hemp research and development
act and any associated rules promulgated by the Michigan department of
agriculture and rural development.
R 420.1003 Processing industrial hemp.
Rule 31003. (1) A
producerprocessor under the MMFLA may handleobtain,
process, market, or broker industrial hemp in compliance with the industrial
hemp research and development act and any associated rules
promulgated under that act by the Michigan department of
agriculture and rural development.
(2) A producer may obtain
industrial hemp to process as allowed under the industrial hemp research and
development act and any associated rules promulgated by the Michigan department
of agriculture and rural development.
(32) A producerprocessor
under the MMFLA shall always store industrial hemp separately from
marihuana products and in compliance with these rules relating to storage of
marihuana products promulgated by the agencymaintain records documenting
all industrial hemp obtained, processed, marketed, or brokered by the processor.
(43) A producer
shall document all industrial hemp obtained by the facility and shall
make those records available to the agency upon request.
(5) A producer shall enter
all transactions, current inventory, and other information into the statewide
monitoring system as required by the industrial hemp research and development
act and any associated rules promulgated by the Michigan department of agriculture
and rural development.
R 420.1004 Severability Selling
industrial hemp.
Rule 41004. If
any rule or subrule of these rules, in whole or in part, is found to be invalid
by a court of competent jurisdiction, such decision will not affect the validity
of the remaining portion of these rules. (1) A marihuana sales location
may handle, market, or broker industrial hemp if the marihuana sales location does
both of the following:
(a) Obtains an industrial hemp processor handler license.
(b) Complies with the requirements of the industrial hemp research and development act and rules promulgated under that act.
(2) A marihuana sales location shall always store industrial hemp separately from marihuana and in compliance with R 420.212.
(3) A marihuana sales location that meets the requirements of subrule (1) of this rule shall maintain records documenting all industrial hemp obtained, marketed, or brokered by the marihuana sales location.
R 420.1005 THC limits in industrial hemp products.
Rule 1005. An industrial hemp product described in section 3(f)(v)(A) of the MRTMA, MCL 333.27953, must not contain more THC than any of the following:
(a) One and three-fourths milligrams per serving.
(b) Ten milligrams per package.
(c) One fifteenth of the amount of CBD that is in the industrial hemp product.