DEPARTMENT OF LICENSING AND REGULATORY AFFAIRS
BUREAU OF MEDICAL MARIHUANA REGULATION
MEDICAL MARIHUANA FACILITIES
Filed with the secretary of state on
These rules take effect immediately upon filing with the secretary of state unless adopted under section 33, 44, or 45a(6) 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.
(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, and Executive Reorganization Order No. 2019-2, MCL 333.27001)
R 333.201, R 333.202, R 333.203, R 333.205, R 333.206, R 333.207, R 333.208, R 333.209, R 333.210, R 333.211, R 333.212, R 333.213, R 333.214, R 333.215, R 333.216, R 333.217, R 333.218, R 333.219, R 333.220, R 333.221, R 333.231, R 333.232, R 333.233, R 333.234, R 333.235, R 333.236, R 333.237, R 333.238, R 333.245, R 333.246, R 333.247, R 333.248, R 333.261, R 333.262, R 333.271, R 333.272, R 333.273, R 333.274, R 333.275, R 333.276, R 333.281, R 333.282, R 333.291, R 333.292, R 333.293, R 333.294, R 333.295, R 333.296, R 333.297, R 333.298, R 333.299 of the Michigan Administrative Code are rescinded, as follows:
PART 1. GENERAL
PROVISIONS
R
333.201 Definitions. Rescinded.
Rule 1. As used in these
rules:
(a) “Act” means the
medical marihuana facilities licensing act, 2016 PA 281, MCL 333.27101 to
333.27801.
(c) “Building”
means a combination of materials forming a structure affording a facility 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
shall not be construed to mean a building incidental to the use for
agricultural purposes of the land on which the building is located.
(d) “Bureau” means the
bureau of medical marihuana regulation in the department of licensing and regulatory
affairs.
(e) “Bureau of fire
services” or “BFS” means the bureau of fire services in the department of
licensing and regulatory affairs.
(f) “Department” means the
department of licensing and regulatory affairs.
(g) “Director” means the
director of the department of licensing and regulatory affairs or his or her
designee.
(h) "Employee"
means a person performing work or service for compensation.
(k) “Limited access area”
means a building, room, or other contiguous area of a marihuana facility where
marihuana is grown, cultivated, stored, weighed, packaged, sold, or processed
for sale and that is under the control of the licensee.
(l) “Marihuana facility”
means a location at which a licensee is licensed to operate under the act and
these rules.
(m) “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.
(n) “Marihuana tracking
act” means the marihuana tracking act, 2016 PA 282, MCL 333.27901 to 333.27904.
(o) “Michigan medical
marihuana act” means the Michigan medical marihuana act, 2008 IL 1, MCL
333.26421 to 333.26430.
(p) “Package
tag” means an RFID tag supplied through the
statewide monitoring system for the purpose of identifying a package containing
a marihuana product.
(q) “Plant tag” means an
RFID tag supplied through the statewide monitoring system for the purpose of
identifying an individual marihuana plant.
(r) “Proposed marihuana
facility” means a location at which an applicant plans to operate under the act
and these rules if the applicant is issued a state operating license.
(s) “Restricted access
area” means a designated and secure area at a marihuana facility where
marihuana products are sold, possessed for sale, and displayed for sale.
(t) “Same location” means
separate state operating licenses that are issued to multiple marihuana
facilities that are authorized to operate at a single property but with
separate business suites, partitions, or addresses.
(u) “Stacked license” means more than 1 state operating license issued to a
single licensee to operate as a grower of
class C-1,500 marihuana plants as specified in each license at a marihuana
facility.
R 333.202 Terms; meanings. Rescinded.
Rule 2. Terms defined in
the act have the same meanings as used in these rules unless otherwise
indicated.
R 333.203 Adoption by
reference. Rescinded.
Rule 3. 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, 2018 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
$99.50.
(b) Cannabis
Inflorescence: Standards of Identity, Analysis, and Quality Control monograph
Revision 2014 published by the American Herbal Pharmacopoeia. A copy of that
publication may be obtained from the American Herbal Pharmacopoeia, P.O. Box
66809, Scotts Valley, California 95067, or at the internet address http://www.herbal-ahp.org/,
for the price of $44.95.
(c) Safe Quality Food
(SQF) Code, 7.2 edition available at http://www.sqfi.com/wp-content/uploads/SQF-Code_Ed-7.2-July.pdf.
(d) The International Organization for
Standardization (ISO), ISO 22000 / ISO/TS 22002-1:2009 - food safety bundle,
available for purchase at: https://webstore.ansi.org/RecordDetail.aspx?sku=ISO+22000+%2f+ISO%2fTS+22002-1+-+Food+Safety+Bundle,
for the price of $275.00.
(e) International
Organization for Standardization (ISO), ISO/IEC 17025:2005 or 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.
(f) The standards adopted
in subdivisions (a) to (e) of this rule are available for inspection and
distribution at the Bureau of Medical Marihuana Regulation, located at 2407 North
Grand River Avenue, Lansing, MI 48906. Copies of these standards may be
obtained from the bureau at cost plus shipping and handling.
PART 2. STATE
OPERATING LICENSE
R
333.205 Application procedure; requirements. Rescinded.
Rule 5. (1) A
person may apply for a state operating license on the form created by the
department accompanied by the application fee as prescribed in these rules.
Each question on the application must be answered by the applicant in its
entirety and all information requested and required by the act and these rules
must be submitted in the application. Failure to comply with these rules and
the application requirements in the act is grounds for denial of the
application.
(2) A person may
submit a partial application under R 333.206 on the condition that it is to
prequalify to complete the remaining application requirements. This application
will have a pending status until all application requirements in R 333.207 are
completed. The department shall not issue a license at this stage of the
application process. The finding of prequalification status for a pending
application is valid for a period of 1 year after the department issued a
notice of prequalification status for a pending application unless otherwise
determined by the department. After 1 year has expired, the applicant may be
required to submit a new application and pay a new application fee.
(3) The
department may delay an application while additional information is requested
including, but not limited to, requests for additional disclosures and
documentation to be furnished to the department.
(4) As used in
this rule, R 333.206, and R 333.207, the term “applicant” includes an officer,
director, and managerial employee of the applicant and a person who holds any
direct or indirect ownership interest in the applicant as provided in section
102 of the act, MCL 333.27102.
R 333.206
Application requirements; financial and criminal background. Rescinded.
Rule 6. (1) The
first part of the application is a financial background and full criminal
history background check of each applicant.
(2) An applicant
shall disclose the identity of every person having any ownership interest in
the applicant with respect to which the license is sought including, but not
limited to, date of birth, government issued identification, and any other
documents required by the act.
(3) Each applicant shall
disclose the financial information required in the act
and these rules in a form created by the department including, but not
limited to, all of the following:
(a) Financial statements,
including information regarding all of the following:
(i) A pecuniary interest.
(ii) Any 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:
(A) Funds.
(B) 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, amounts, securities, or lender
information.
(b) Property ownership
information, including, but not limited to, deeds, leases, rental agreements,
real estate trusts, purchase agreements, or institutional investors.
(c) Tax
information, including, but not limited to, W-2 and 1099 forms, and any other
information required by the department.
(d) For in-state
and out-of-state applicants, the applicant’s business organizational documents
filed with this 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 or foreign entity, if applicable.
(e) Disclosure
by the applicant of the identity of any other person who meets either of the
following:
(i) Controls,
directly or indirectly, the applicant.
(ii) Is
controlled, directly or indirectly, by the applicant or by a person who
controls, directly or indirectly, the applicant.
(f) Written
consent by the applicant to a financial background investigation as authorized under
the act and these rules.
(g) Disclosure
by the applicant of any true parties of interest as required in section 404 of
the act, MCL 333.27404.
(h) Disclosure
by the applicant of the stockholders or other persons having a 1% or greater
beneficial interest in the proposed marihuana facility as required in section
303 of the act, MCL 333.27303.
(i) The sources
and total amount of the applicant's capitalization to operate and maintain the
proposed marihuana facility in compliance with R 333.212.
(j) A financial
statement attested by a certified public accountant (CPA), on a form created by
the department, including a foreign-attested CPA statement, or its equivalent
if applicable, on capitalization pursuant to R 333.212.
(k) Information
on the financial ability of the applicant to purchase and maintain adequate
liability and casualty insurance in compliance with R 333.211.
(l) Any other
documents, disclosures, or attestations created or requested by the department
that are not inconsistent with the act or these rules.
(4) Each applicant shall
disclose to the department his or her criminal history background information
and regulatory compliance as provided under the act and these rules in a form
created by the department, including, but not limited to, all the following:
(a) An
attestation in writing that the person consents to inspections,
examinations, searches, and seizures that are permitted under the act and
these rules.
(b) Written
consent to a criminal history check, submission of a passport quality
photograph, and handwriting exemplar as required under section 402 of the act,
MCL 333.27402.
(c) One set of
fingerprints to the department of state police in accordance with section 402
of the act, MCL 333.27402, and these rules for each applicant, each person
having any ownership interest in the proposed marihuana facility.
(d) An
attestation affirming a continuing duty to provide information requested by the
department and to cooperate in any investigation, inquiry, or hearing.
(e) An
attestation acknowledging that sanctions may be imposed for violations on a
licensee while licensed or after the license has expired, as provided in the
act and these rules.
(f) Disclosure
of noncompliance with any regulatory requirements in this state or any other
jurisdiction.
(h) Any other documents,
disclosures, or attestations created or requested by the department that are
not inconsistent with the act or these rules.
(5) An applicant shall
submit in the application any information requested and required by the act and
these rules.
R 333.207 Application requirements; complete application. Rescinded.
Rule 7. A complete
application for a state operating license must include all the information
specified in R 333.206 and all of the following:
(a) A description of the
type of marihuana facility, including all of the following:
(i) An estimate of or
actual number of employees.
(ii) The projected or
actual gross receipts.
(iii) A
business plan.
(iv) The
proposed location of the marihuana facility.
(v) A
security plan, as required under the act and these rules.
(b) A copy of the proposed
marihuana facility plan, as required under R 333.209.
(c) An applicant shall
pass the prelicensure inspection as determined by the department and as
required in R 333.210.
(d) Confirmation of
compliance with the municipal ordinance as required in section 205 of the act,
MCL 333.27205, and these rules. For purposes of these rules, confirmation of
compliance must be on an attestation form prepared by the department that
contains all of the following information:
(i) Written affirmation
that the municipality has adopted an ordinance under section 205 of the act,
MCL 333.27205, including, if applicable, a description of any limitations on
the number of each type of marihuana facility.
(ii) Description of any
zoning regulations within the municipality that apply to the proposed marihuana
facility.
(iii) The 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 signature of the
applicant.
(v) The marihuana facility
name and address.
(vi) Attestation that any
changes that occur with the municipal ordinance or any violations of a
municipal or zoning ordinance will be reported to the department.
(e) The disclosure of the
true party of interest as required in section 404 of the act, MCL 333.27404,
and these rules.
(f) The disclosure of
persons that have a beneficial interest as required in section 303(1)(g) of the
act, MCL 333.27303.
(g) Additional information
and documents requested by the department not inconsistent with the act and
these rules.
(h) Any other documents,
disclosures, or attestations created or requested by the department that are
not inconsistent with the act and these rules.
R 333.208 Application; fees;
assessment. Rescinded.
Rule 8. (1) An
applicant for a state operating license shall submit an application that is
accompanied by the nonrefundable application fee of $6,000.00 upon initial
application, as required under these rules.
(2) If the costs of the
investigation and processing the application exceed the application fee, the
applicant shall pay the additional amount.
(3) An applicant
shall pay the regulatory assessment, if applicable, on or before the date the
licensee begins operating and annually thereafter, pursuant to section 603 of
the act, MCL 333.27603, and these rules.
(4) The
department shall not issue a license until a complete application is submitted,
the fees required under these rules are paid, and the department determines
that the applicant is qualified to receive a license under the act and these
rules.
R 333.209 Marihuana facility
plan. Rescinded.
Rule 9. (1) An applicant
shall submit a marihuana facility plan for the proposed marihuana facility as
required in R 333.207 and upon request by the department. Upon the request of
the department, an applicant or licensee may be required to submit a revised
marihuana facility plan.
(2) The marihuana facility
plan must include, but is not limited to, all of the following:
(a) The type of proposed
marihuana facility, the location of the marihuana facility, a description of
the municipality where the marihuana facility will be located, and any of the
following, if applicable:
(i) A statement in the
marihuana facility plan that a combination of state operating licenses will
operate as separate marihuana facilities at the same location, as provided
under R 333.232.
(ii) A statement in the
marihuana facility plan that the applicant has or intends to apply to stack a
license at the proposed marihuana facility as provided under R 333.220.
(b) A diagram of the
marihuana facility including, but not limited to, all of the following:
(i) The proposed
facility’s size and dimensions.
(ii) Specifications of the
marihuana facility.
(iii) Physical address.
(iv) Location of common
entryways, doorways, or passageways.
(v) Means of public entry
or exit.
(vi) Limited-access areas
within the marihuana facility.
(vii) An indication of the
distinct areas or structures for separate marihuana facilities at the same location
as provided in R 333.232.
(c) A detailed floor plan
and layout that includes all of the following:
(i) Dimensions of the
marihuana facility 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.
(viii) Quantities of
hazardous materials, such as chemical, flammable/combustible liquids and gases,
and the expected daily consumption of the hazardous materials.
(d) Means of egress,
including, but not limited to, delivery and transfer points.
(e) Construction details
for structures and fire-rated construction for required walls.
(f) Building structure
information, including but not limited to, new, pre-existing, free-standing, or
fixed.
(g) Building type information,
including but not limited to, commercial, warehouse, industrial, retail,
converted property, house, building, mercantile building, pole barn,
greenhouse, laboratory, or center.
(h) Zoning classification
and zoning information.
(i) If the proposed
marihuana facility is in a location that contains multiple tenants and any
applicable occupancy restrictions.
(j) A proposed security
plan that demonstrates the proposed marihuana facility meets the security
requirements specified in R 333.235.
(k) Any other information
required by the department if not inconsistent with the act and these rules.
(3) Any changes or
modifications to the marihuana facility plan under this rule must be reported
to the department and may require preapproval by the department.
(4) The department may
provide a copy of the marihuana facility plan to the BFS, local fire
department, and local law enforcement for use in pre-incident review and
planning.
(5) The department may
reinspect the marihuana facility to verify the plan at any time and may require
that the plan be resubmitted upon renewal.
R 333.210 Prelicensure
investigation; proposed marihuana facility inspection. Rescinded.
Rule 10. (1) An applicant
for a state operating license shall submit to a prelicensure physical
inspection of a proposed marihuana facility, as determined by the department.
(2) The department shall
establish an inspection process to confirm that the applicants and proposed
marihuana facilities meet the requirements of the act and these rules.
(3) The department shall
investigate an applicant in accordance with the act and these rules.
(4) The
department, through its investigators, agents, auditors, or the state police,
shall conduct inspections and examinations of an applicant and a proposed
marihuana facility in accordance with the act and these rules.
(5) An applicant shall
submit proof to the department 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.
(b) A fire safety
inspection as specified in R 333.234.
R 333.211 Proof of financial
responsibility; insurance. Rescinded.
Rule 11. (1) Before a
license is issued or renewed, the licensee or renewal applicant shall file a
proof of financial responsibility for liability for bodily injury on the form
prescribed in section 408 of the act, MCL 333.27408, 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 department.
(2) In addition to the
proof of financial responsibility requirements contained in subrule (1) of this
rule, a renewal applicant or licensee 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 premises liability to the department no later than 60 days
after a state operating license is issued or renewed.
(3) A secure transporter
shall show proof of auto insurance, vehicle registration, and registration as a
commercial motor vehicle, as applicable, for any transporting vehicles used to
transport marihuana product as required by the act and these rules.
R 333.212 Capitalization
requirements. Rescinded.
Rule 12. (1) An applicant
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 shall
provide proof to the department of the capitalization amounts specified in
subrule (2)(a) to (g) of this rule from both of the following sources:
(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.
R
333.213 Denial of issuance of license; additional reasons. Rescinded.
Rule 13. (1) If an
applicant fails to comply with the act or these rules, a license may be denied
by the department as provided under the act and these rules.
(2) In addition to the
reasons for denial in the act, a license may be denied by the department as
provided in the act and these rules for any of the following reasons:
(a) The applicant’s
marihuana facility plan does not fully comply with the act or these rules.
(b) The applicant’s
proposed marihuana facility or marihuana facility is substantially different
from the marihuana facility plan pursuant to R 333.209 and these rules.
(c) The department is
unable to access the proposed marihuana facility for prelicensure physical
inspection or the applicant denied the department access to the proposed
marihuana facility.
(d) The applicant made a
material misrepresentation on the application.
(e) The applicant failed
to correct any deficiencies within the application in accordance with section
403 of the act, MCL 333.27403, and these rules.
(f) The applicant failed
to satisfy the confirmation of compliance by a municipality in accordance with
section 205 of the act, MCL 333.27205, and these rules.
(g) The applicant is
operating a proposed marihuana facility or marihuana facility without a license
after December 15, 2017, that would otherwise require a state operating license
under the act and these rules. This subdivision does not apply to an applicant
that applied no later than February 15, 2018, has a valid temporary operation
attestation from the municipality in which the proposed marihuana facility is
operating on file with the department, and is operating a proposed marihuana
facility pursuant to the emergency rules filed October 1, 2018, while in
effect, and any extension, if applicable.
R
333.214 Renewal of license. Rescinded.
Rule 14. (1) A license is
issued for a 1-year period and is renewable annually. A licensee may apply to
renew a license on a form established by the department. The licensee shall
pay the regulatory assessment upon renewal. The state operating license may be
renewed if not less than 90 days before expiration of the license, the licensee
has submitted the renewal form required by the department and the licensee pays
the department for any additional background investigation charge assessed by
the department under these rules. The department shall include on the renewal
form, without limitation, a statement requesting renewal of the license and all
of the following information:
(a) To the extent that
information has changed or not been previously reported, updated personal,
business, and financial information, as the department may require, related to
the eligibility, suitability, and general fitness of the licensee to continue
to hold the license for which renewal is requested under the act and these
rules, including, without limitation, information regarding the identification,
integrity, moral character, reputation, and relevant business experience,
ability, and probity, and financial experience, ability, and responsibility of
the licensee and each person required to be qualified for renewal of the
license under the act and these rules. To the extent that the information has
changed or not been previously reported, updated information on the marihuana
facility.
(b) A statement under oath
by the licensee that the information provided in the licensee's annual renewal
form is current, complete, true, and accurate, and that the licensee has
fulfilled its obligation under the act and these rules to notify the department
of any change in information provided in its original license application and
subsequent annual renewal form or forms previously filed, if applicable.
(c) Attestation by the
municipality on a form created by the department regarding a licensee who submits
an application for license renewal which shall include, but not be limited to
both of the following:
(i) A description of a
violation, if applicable, of an ordinance or a zoning regulation adopted
pursuant to section 205 of the act, MCL 333.27205, committed by the licensee,
but only if the violation relates to activities licensed under the act, the
Michigan medical marihuana act, or these rules.
(ii) Whether there has
been a change to an ordinance or a zoning regulation adopted pursuant to section
205 of the act, MCL 333.27205, since the license was issued to the licensee and
a description of the change.
(d) Attestation by the
licensee that the licensee's annual renewal form provides all information and
documentation prescribed and required by the department to establish and
determine that the licensee is eligible, qualified, and suitable to have its
state operating license renewed and is ready and able to continue conducting
its marihuana facility in compliance with the act and these rules throughout
the new 1-year time period for which the license is to be renewed.
(e) Other relevant
information and documentation that the department may require to determine the
licensee's eligibility, suitability, and qualification to have its license renewed
under the licensing standards of the act and this part.
(2) If a license renewal
application 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 regulatory assessment under section 603 of
the act, MCL 333.27603, and satisfaction of any renewal requirements. The
licensee may continue to operate during the 60 days after the license
expiration date if the licensee submits renewal application to the department
and complies with the other requirements for renewal.
(3) Failure to comply with
any of the provisions in the act and these rules may result in the nonrenewal
of a license. A state operating license shall not be renewed unless the
department has determined that the individual qualifications of each person
required by the act and these rules is eligible, qualified, and suitable as
part of the license renewal in accordance with the relevant licensing standards
set forth in the act and these rules.
(4) The licensee shall
meet the requirements of the act and any other renewal requirements set forth
in these rules.
(5) The department may
refuse to renew a state operating license and issue a notice of nonrenewal if
the licensee fails to apply for renewal in accordance with section 402 of the
act, MCL 333.27402 and this rule. In addition, the department may refuse to
renew a state operating license and issue a notice of nonrenewal if the
department determines, after reviewing the licensee's annual renewal form, that
the license should not be renewed because the licensee's annual renewal form
does not provide the information and documentation required by the department
to determine that the licensee is eligible, qualified, and suitable to continue
to be licensed and ready and able to continue conducting its marihuana facility
operation in compliance with the act and these rules.
(6) A state operating
licensee who is served with a notice of nonrenewal under this rule may request
a hearing under these rules.
(7) 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
department.
(8) A person who has not
applied for 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, in accordance with the act or these rules.
R 333.215 Notification and
reporting. Rescinded.
Rule 15. (1)
Applicants and licensees have a continuing duty to provide the department with
up-to-date contact information and shall notify the department in writing of
any changes to the mailing addresses, phone numbers, electronic mail addresses,
and other contact information they provide the department.
(2) Applicants
and licensees shall report any changes to the marihuana facility operations
that are required in R 333.231 to R 333.238 and as required in the act and
these rules, as applicable.
(3) Applicants
and licensees shall report material changes to the department before making a
material change that may require prior authorization by the department.
Material changes, include, but are not limited to, the following:
(a) Change in
owners, officers, members, or managers.
(b) Change of
location. Upon notification of a change in location, the department may
determine that a new license and new inspection are required for the change of
location.
(c) A
description of a violation of an ordinance or a zoning regulation adopted
pursuant to section 205 of the act, MCL 333.27205, committed by the licensee,
but only if the violation relates to activities licensed under the act, the
Michigan medical marihuana act, and these rules.
(d) The addition
or removal of persons named in the application or disclosed.
(e) Change in
entity name.
(f) Any
attempted transfer, sale, or other conveyance of an interest in a license.
(g) Any change
or modification to the marihuana facility for prelicensure or post-licensure
that was not preinspected, inspected, or part of the marihuana facility plan or
final inspection including, but not limited to, operational or method changes requiring
inspection under these rules, additions or reductions in equipment or
processors at a marihuana facility, increase or decrease in the size or
capacity of the marihuana facility, alterations of ingress or egress, and
changes that impact security, fire and building safety.
(4) An applicant
or licensee shall notify the department within 1 business day of becoming aware
of or should have been aware of all the following:
(a) Adverse
reactions to a marihuana product sold or transferred by any licensee.
(b) Criminal
convictions, charges, or civil judgements against an applicant or licensee in
this state or any other state.
(c) Regulatory
disciplinary action taken or determined against an applicant or licensee by
this state or any other state, including any pending action.
(5) Failure to
report material changes pursuant to subrule (3) of this rule or notifications
under subrule (4) of this rule may result in sanctions or fines, or both.
R 333.216 Notifications of
diversion, theft, loss, or criminal activity pertaining to marihuana product. Rescinded.
Rule 16. (1) A
licensee and an applicant shall notify the department, state police, and local
law enforcement authorities within 24 hours of becoming aware of or should have
been aware of the theft or loss of any marihuana product or criminal activity
at the marihuana facility.
(2) Failure to
notify as required under subrule (1) of this rule may result in sanctions or
fines, or both.
R
333.217 Inspection; investigation. Rescinded.
Rule 17. (1) The
department shall do all of the following with respect to inspections and
investigations of applicants, licensees, proposed marihuana facilities, and
marihuana facility operations:
(a) Oversee and conduct
inspections through its investigators, agents, auditors, or the state police of
proposed marihuana facilities and marihuana facilities as provided in section
303 of the act, MCL 333.27303, to ensure compliance with the act and these
rules.
(b) Investigate
individuals employed by marihuana facilities.
(c) Inspect and examine
marihuana facilities and proposed marihuana facilities.
(d) Inspect, examine, and
audit records of the licensee.
(2) The department may at
any time, through its investigators, agents, auditors, or the state police,
without a warrant and without notice to the licensee, enter the proposed
marihuana facility or marihuana facility, offices, or other places of business
of a licensee, if evidence of compliance or noncompliance is likely to be found
in accordance with the act and these rules.
(3) The department,
through its investigators, agents, auditors, or the state police, 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 act
or these rules.
(4) The department,
through its investigators, agents, auditors, or the state police, may inspect,
examine, and audit relevant records of the licensee. If a licensee fails to
cooperate with an investigation, the department through its investigators,
agents, auditors, or the state police may impound, seize, assume physical
control of, or summarily remove records from a proposed marihuana facility or
marihuana facility.
(5) The department through
its investigators, agents, auditors, or the state police may eject or exclude,
or authorize the ejection or exclusion of, an individual from a proposed
marihuana facility or marihuana facility if that individual violates the act, a
final order, or these rules.
(6) The department through
its investigators, agents, auditors, or the state police may take any
reasonable or appropriate action to enforce the act and rules.
(7) This rule does not
limit the application of any other remedies or sanctions that are available
through local, state, and federal laws, the act, and these rules.
(8) For purposes of this
rule, the term “record” means books, ledgers, documents, writings, photocopies,
correspondence, electronic records, videotapes, surveillance footage,
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.
R
333.218 Persons subject to penalty; violations. Rescinded.
Rule 18. (1) If the
department through its investigators, agents, auditors, or the state police
during the physical site inspection determine violations of the act or these
rules exist, the department 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 responsible for sanctions or fines, or both.
(2) The department may
issue a notice of a violation or fine, or both, for any violations of the act
and applicable rules, including those observed by the department through its investigators, agents, auditors, or the state
police while in the performance of their duties.
(3) If the department
through its investigators, agents, auditors, or the state police determine a
violation of the act or these rules exists, these violations must be cited in a
format established by the department. After a notice of violation or fine, or
both, is issued to a person, applicant, or licensee, the department may hold a
compliance conference or a hearing if applicable as prescribed in the act and
these rules.
(4) The department may
forward information regarding violations of the act or these rules or any other
state or federal law to the state police, department of attorney general, and
the prosecutor for the jurisdiction in which the alleged violation of the act
or rules has occurred.
(5) The department may
take action for failure to pay any fine within the time written on the
violation notice pursuant to the act or these rules.
R 333.219 Sanctions; fines. Rescinded.
Rule 19. (1) A person, applicant,
or licensee found in violation of these rules or the act may be subject to
sanctions, including, but not limited to, any of the following:
(a) License denial.
(b)
Limitations on a license.
(c) Fines.
(d)
Revocation, suspension, nonrenewal, or an administrative hold on a license.
(e) Orders
to cease operations.
(2) A violation of these
rules, the act, the marihuana tracking act, or any ordinance adopted under
section 205 of the act, MCL 333.27205, may result in 1 or more of the
following:
(a) A license may be
denied, limited, revoked, or restricted.
(b) A licensee or an
employee of a licensee may be removed.
(c) Civil fines of up to
$5,000.00 may be imposed against an individual.
(d) 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 act, these rules, or an
order.
(e) Civil fines may be
assessed for each day the licensee is not in compliance with the act 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 act or
these rules.
(3) A 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 facility's
operation as provided in the act or these rules.
(4) A person operating
without a state operating license shall cease operation and may be subject to,
including but not limited to, sanctions or fines, or both, in accordance with
the act or these rules and may be referred to the state police and department
of attorney general.
(5) The attempted transfer, sale, or other conveyance of an
interest in a license without prior approval are grounds for suspension or
revocation of the license or for other sanction as provided in sections 406 and
409 of the act, MCL 333.27406 and MCL 333.27409, or these rules.
(6) The department may
impose any other remedies, sanctions, or penalties not inconsistent with the
act or these rules.
R
333.220 Stacked license. Rescinded.
Rule 20. A grower that has
already been issued a state operating license specified as a class C-1,500
marihuana plants may apply to stack a license at a marihuana facility specified
in the state operating license. The grower shall be subject to payment of a
separate regulatory assessment for each state operating license stacked and may
be subject to any additional fees under R 333.208. In addition, the grower is
subject to all requirements of the act and these rules.
R 333.221 Changes to
licensed marihuana facility. Rescinded.
Rule 21. (1) Any change or
modification to the marihuana facility after licensure is governed by the
standards and procedures set forth in the act and these rules and any
regulations adopted pursuant to the act. Any material change or modification to
the marihuana facility must be approved by the department before the change or
modification is made.
(2) Any change of a location
of a marihuana facility after licensure requires a new license application
under R 333.206 and R 333.207 and may include, but is not limited to,
regulatory assessment or application fees, or both. A licensee shall produce
written documentation from the municipality approving the proposed new
marihuana facility location as indicated on the application form provided to
the department and be in compliance with section 205 of the act, MCL 333.27205.
PART 3. OPERATIONS
R 333.231 State operating licenses; licensees;
operations; general. Rescinded.
Rule 31. (1) A state
operating license and a stacked license as described in R 333.220 are limited
to the scope of the state operating license issued for that type of marihuana
facility that is located within the municipal boundaries connected with the
license.
(2) A licensee shall
comply with all of the following:
(a) Marihuana facilities
shall be partitioned from any other marihuana facility, activity, business, or
dwelling. Marihuana facilities shall not allow onsite or as part of the
marihuana facility any of the following:
(i) Sale, consumption, or
serving of food except for as provided in R 333.281.
(ii) Sale, consumption, or
use of alcohol or tobacco products.
(iii) Consumption, use, or
inhalation of a marihuana product.
(b) A marihuana facility
shall have distinct and identifiable areas with designated structures that are
contiguous and specific to the state operating license.
(c) A marihuana facility
shall have separate entrances and exits, inventory, record keeping, and point
of sale operations, if applicable.
(d) Access to the
marihuana facility is restricted to the licensee; employees of the licensee;
and, the department through its investigators, agents, auditors, or the state
police. A provisioning center may grant access as provided in R 333.233(3) to
registered qualifying patients and registered primary caregivers with valid
registry cards to a dedicated point of sale area. A separate waiting area may
be created for visitors not authorized to enter the marihuana facility. The
licensee shall maintain a log tracking all visitors to a marihuana facility.
The visitor log must be available at all times for inspection by the department
through its investigators, agents, auditors, or the state police to determine
compliance with the act and these rules.
(e) Licensee records must
be maintained and made available to the department upon request.
(f) The marihuana facility
must be at a fixed location. Mobile marihuana facilities and drive through
operations are prohibited. Any sales or transfers of marihuana product by
internet or mail order, consignment, or at wholesale are prohibited.
(g) A state operating
license issued under the act must be framed under a transparent material and
prominently displayed in the marihuana facility.
(3) A marihuana facility
must comply with any other operational measures requested by the department
that are not inconsistent with the act and these rules.
R 333.232 Operation at same
location. Rescinded.
Rule 32. (1) A
licensee that has any combination of state operating licenses may operate
separate marihuana facilities at the same location. For purposes of this rule,
a stacked license is considered a single marihuana facility.
(2) To operate
at the same location subject to subrule (1) of this rule, all of the following
requirements must be met:
(a) The
department 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 type or number of marihuana facilities under
section 205 of the act, MCL 333.27205, or prohibits the operation at the same
location.
(d) The licensee
of each marihuana facility operating at the same location under this rule shall
do all the following:
(i) Apply for
and be granted separate state operating licenses and pay a separate regulatory assessment
for each state operating license.
(ii) Have distinct and
identifiable areas with designated structures that are contiguous and specific
to the state operating license.
(iii) Have separate
entrances and exits, inventory, record keeping, and point of sale operations,
if applicable.
(iv) Post the state
operating license on the wall in its distinct area and as provided in these
rules.
(vi) Comply with
the provisions in the act and these rules.
(3) Operation of a state
operating license at the same location that includes a licensed provisioning
center shall have the entrance and exit to the licensed provisioning center
marihuana facility and entire inventory physically separated from any of the
other licensed marihuana facility or facilities so that individuals can clearly
identify the retail entrance and exit.
R 333.233 Marihuana facilities; requirements. Rescinded.
Rule 33. (1) A
grower shall operate a marihuana facility under either of the following
conditions:
(a) The
marihuana facility 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 333.234 and these rules.
(b) The
marihuana facility operations are within a building, except that cultivation
may occur in an outdoor area, and 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 block outside visibility of
the marihuana plants from the public view, with no marihuana plants growing
above the fence or barrier that is visible to the public eye 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 333.234 and these rules.
(2) A secure transporter
shall have a primary place of business as its marihuana facility that is
operating in a municipality that has adopted an ordinance that meets the
requirements of section 205 of the act, MCL 333.27205, and these rules and its
marihuana facility must comply with the requirements prescribed by the act and
these rules. A secure transporter shall hold a separate license for every marihuana
facility location where a marihuana product is stored. A secure transporter may
travel through any municipality to transport a marihuana product. A secure
transporter shall comply with all of the following:
(a) The secure transporter
may take physical custody of the marihuana or money but legal custody belongs
to the transferor or transferee.
(b) A secure transporter
shall not sell or purchase marihuana products.
(c) A secure 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. A secure transporter of marihuana
product from separate marihuana facilities 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 secure transporter transports money
associated with the purchase or sale of marihuana product between facilities,
the secure 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 secure transporter
shall log and track all handling of money associated with the purchase or sale
of marihuana between facilities. These records must be maintained and made
available to the department upon request.
(e) A secure transporter
shall have a route plan and manifest available for inspection by the department
through its investigators, agents, auditors, or the state police to determine
compliance with the act and these rules. A copy of the route plan and manifest
must be carried with the secure transporter during transport between marihuana
facilities. A secure transporter is subject to administrative inspection by a
law enforcement officer at any point during the transportation of marihuana
product pursuant to the act or these rules. A secure 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 secure transporter
shall follow the manifest. In cases of emergencies, the secure transporter
shall notify the transferor and transferee, update the statewide monitoring
system, and revise the manifest to reflect the unexpected change to the
original manifest.
(g) The timeframe for the
secure transporter to maintain custody of the marihuana product must not be
more than 48 hours or by permission of the department on a case-by-case basis.
(h) A secure transporter
shall identify and record all vehicles with the department and have the
required vehicle registration with the secretary of state as required under
state law. A secure transporter’s vehicles are subject to inspection at any
time by the department, through its investigators,
agents, auditors, or the state police to determine compliance with the act
or these rules.
(3) A provisioning center
shall 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 act and these rules.
The provisioning center shall keep marihuana products behind a counter or other
barrier to ensure that a registered qualifying patient or registered primary
caregiver does not have direct access to the marihuana products. The sale or
transfer of a marihuana product to a registered qualifying patient who is under
the age of 18 must be made by the provisioning center to the registered
qualifying patient’s parent or legal guardian who serves as the registered
qualifying patient’s registered primary caregiver.
(5) A marihuana facility
shall enter in the statewide monitoring system all transactions including, but
not limited to, current inventory. These records must be maintained and made
available to the department upon request.
R 333.234 Building and fire safety. Rescinded.
Rule 34. (1) An applicant’s
proposed marihuana facility and a licensee’s marihuana facility 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 postlicensure 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; the elevator safety board act, 1967
PA 227, MCL 408.801 to 408.824; and, the elevator licensing act, 1976 PA 333,
MCL 338.2151 to 338.2160.
(3) An applicant or licensee
shall not operate a marihuana facility unless a permanent certificate of
occupancy has been issued by the appropriate enforcing 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 facility or marihuana facility as provided in the act and these
rules. The issuance, enforcement, and inspection of building permits under
this act may remain 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 facility or marihuana facility
as provided in the act and these rules.
(4) An applicant or licensee
shall not operate a marihuana facility unless the proposed marihuana facility
or marihuana facility has passed the prelicensure fire safety inspection by the
BFS. The state fire marshal, or his or her authorized designee, may conduct
pre-licensure and post-licensure inspections of a marihuana facility. An
applicant or licensee shall comply with the all of the following:
(a) A BFS inspection may be
conducted at any reasonable time to ensure fire safety compliance as provided
in this rule and subrule (5) of this rule. 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
marihuana facilities 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 facilities 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 his or her authorized designee, may conduct a BFS
fire safety inspection of marihuana facility, at any reasonable time to ensure
compliance with the national fire protection association (NFPA) standard 1,
2018 edition, entitled “fire code,” which is adopted by reference in R
333.203. A licensee shall comply with the NFPA 1 as adopted and the following
additional requirements:
(a) Ductwork must be installed
with 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, may be required to meet the suppression needs within a marihuana
facility.
(c) Processors, growers, and
safety compliance facilities 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, growers and processors
shall also comply with all of the following:
(a) Permit the department or
its authorized agents, or state fire marshal or his or her authorized designee,
to enter and inspect a grower and processor marihuana facility at any
reasonable time.
(b) Have conducted, in addition
to any inspections required under the act and these rules, fire safety
inspections that are required 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 facility.
(ii) Changes in occupancy.
(iii) Material changes to a new
or existing grower or processor facility including changes made prelicensure
and postlicensure.
(iv) Changes in extraction
methods and processing or grow areas and building structures may trigger a new
inspection.
(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:
(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
facility and equipment used in the detection of flammable or toxic gases, or
both, must be approved by the BFS and may require construction permits.
R 333.235 Security measures;
required plan; video surveillance system. Rescinded.
Rule 35. (1) An applicant
for a license to operate a proposed marihuana facility shall submit a security
plan that demonstrates, at a minimum, the ability to meet the requirements of
this rule.
(2) A licensee shall
ensure that any person at the marihuana facility, except for employees of the
licensee, are escorted at all times by the licensee or an employee of the
licensee when in the limited-access areas at the marihuana facility.
(3) A licensee shall
securely lock the marihuana facility, including all interior rooms, windows,
and points of entry and exits, with commercial-grade, nonresidential door
locks. Locks on doors that are required for egress shall meet the requirements
of NFPA 1, local fire codes, and the Michigan building code.
(4) A licensee shall
maintain an alarm system at the marihuana facility. Upon request, a licensee
shall make available to the department 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
delivering still photos.
(6) A licensee shall
ensure the video surveillance system does all the following:
(a) Records, at a minimum,
the following areas:
(i) Any areas where
marihuana products are weighed, packed, stored, loaded, and unloaded for
transportation, prepared, or moved within the marihuana facility.
(ii) Limited-access areas
and security rooms. Transfers between rooms must be recorded.
(iii) Areas storing a
surveillance system storage device with not less than 1 camera recording the
access points to the secured surveillance recording area.
(iv) The entrances and
exits to the building must be recorded from both indoor and outdoor vantage
points. The areas of entrance and exit between marihuana facilities at the same
location if applicable, including any transfers between marihuana facilities.
(v) Point of sale areas
where marihuana products are sold and displayed for sale.
(b) Records at all times
images effectively and efficiently of the area under surveillance with a
minimum of 720p resolution.
(7) A licensee shall
install each camera so that it 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 facility 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
cameras that record continuously 24 hours per day and recorded images must
clearly and accurately display the time and date.
(9) A licensee shall
secure the physical media or storage device on which surveillance recordings
are stored in a manner to protect the recording from tampering or theft.
(10) A licensee shall keep
surveillance recordings for a minimum of 30 days, except in instances of
investigation or inspection by the department, through its investigators,
agents, auditors, or the state police, in which case the licensee shall retain
the recordings until the time as the department notifies the licensee that the
recordings may be destroyed.
(11) Surveillance
recordings of the licensee are subject to inspection by the department, through
its investigators, agents, auditors, or the state police, and must be kept in a
manner that allows the department to view and obtain copies of the recordings
at the marihuana facility immediately upon request. The licensee shall also
send or otherwise provide copies of the recordings to the department upon
request within the time specified by the department.
(12) A licensee shall
maintain a video surveillance system equipped with a failure notification
system that provides notification to the licensee of any interruption or
failure of the video surveillance system or video surveillance system storage
device.
(13) A licensee shall
maintain a log of the recordings, which includes all of the following:
(a) The identities of the
employee or employees responsible for monitoring the video surveillance system.
(b) The identity of the
employee who removed the recording from the video surveillance system storage
device and the time and date removed.
(c) The identity of the
employee who destroyed any recording.
R 333.236 Prohibitions. Rescinded.
Rule 36. (1) Marihuana
products not identified and recorded in the statewide monitoring system
pursuant to the act, the marihuana tracking act, or these rules must not be at
a marihuana facility. A licensee shall not transfer or sell a marihuana product
that is not identified in the statewide monitoring system pursuant to the act
or these rules.
(2) Any marihuana product
without a batch number or identification tag or label pursuant to these rules
must not be at a marihuana facility. 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 violation of these
rules may result in sanctions or fines, or both, in accordance with the act or
these rules.
R 333.237 Marihuana product
destruction and waste management. Rescinded.
Rule 37. (1) A marihuana
product that is to be destroyed or is considered waste must be rendered into an
unusable and unrecognizable form through grinding and incorporating the
marihuana product waste with the non-consumable solid waste specified in
subdivisions (a) to (h) of this subrule so that the resulting mixture is not
less than 50% non-marihuana product 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) Other wastes approved
by the department that will render the marihuana product waste unusable and
unrecognizable.
(h) Soil.
(2) A marihuana product
rendered unusable and unrecognizable and, therefore, considered waste, must be
recorded in the statewide monitoring system.
(3) A licensee shall not
sell marihuana waste or marihuana products that are to be destroyed, or that
the department orders destroyed.
(4) A licensee shall
manage all waste that is hazardous waste pursuant to part 111 of the natural
resources and environmental protection act, 1994 PA 451, MCL 324.11101 to
324.11153.
(5) A licensee shall
dispose of marihuana product 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 manned and permitted
solid waste landfill.
(b) A manned compostable
materials operation or facility.
(c) An in-vessel digester.
(d) An incineration method
approved by state and local laws and regulations.
(6) 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.
(7) A licensee shall maintain accurate and
comprehensive records regarding marihuana product waste that accounts for,
reconciles, and evidences all waste activity related to the disposal. The
department may publish guidance on marihuana product waste management.
(8) For the purposes of
this rule, “unrecognizable” means marihuana product rendered indistinguishable
from any other plant material.
R 333.238 Storage of marihuana
product. Rescinded.
Rule 38. (1) All
inventories of marihuana products must be stored at a marihuana facility in a
secured limited access area or restricted access area and must be identified
and tracked consistently in the statewide monitoring system under the act, the
marihuana tracking act, or these rules.
(2) All containers used to
store marihuana products for transfer or sale between marihuana facilities 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 act, the marihuana tracking act,
and these rules.
(3) All chemicals or
solvents must be stored separately from marihuana products and kept in locked
storage areas.
(4) Marihuana-infused
products, edible marihuana products, or materials used in direct contact with
such marihuana-infused products or edible marihuana products, must have
separate storage areas from toxic or flammable materials.
(5) Edible marihuana
products must be stored in compliance with current good manufacturing practice
in manufacturing, packing, or holding human food, 21 CFR part 110. Edible
marihuana products not in final packaging must be stored separately from other
types of marihuana product in compliance with these rules.
(6) A provisioning center
shall store all marihuana products for transfer or sale behind a counter or
other barrier separated from stock rooms.
(7) A safety compliance
facility 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 act and these rules.
PART 4. TESTING
R
333.245 Plant batches; testing procedures. Rescinded.
Rule 45. (1) A grower
shall uniquely identify each immature plant batch in the statewide monitoring
system. Each immature plant batch must not consist of more than 100 immature
plants.
(2) A grower shall tag
each 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 grower shall
delineate or 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 growth span so that all plants can be easily identified and
inspected pursuant to the act and these rules. A grower shall ensure that
identification information is recorded in the statewide monitoring system in
accordance with the act, the marihuana tracking act, and these rules.
(4) After 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 safety compliance facility. A grower shall quarantine a
harvest batch from other plants or batches that has test results pending. A
harvest batch must be easily distinguishable from other harvest batches until
the batch is broken down into packages.
(6) After test results
show a passed test and the harvest batch is packaged, the grower shall destroy
the individual plant tags. Each package must have a package tag attached. A
grower shall ensure this information is placed in the statewide monitoring
system in accordance with the act, the marihuana tracking act, and these rules.
(7) A grower shall not
transfer or sell any marihuana product that has not been packaged with a
package tag attached and recorded in the statewide monitoring system in
accordance with the act, the marihuana tracking act, and these rules.
(8) After a processor
receives or purchases a package in the statewide monitoring system, and the
processor proceeds to process the marihuana product in accordance with the
scope of a processor license, the act, and these rules, the processor shall
give the marihuana product a new package tag anytime the marihuana product
changes form or is incorporated into something else.
(9) After a package is
created by a processor of the marihuana product in its final state, the
processor shall have the sample tested pursuant to R 333.247 and R 333.248. The
processor shall not transfer or sell a final package until after test results
indicate a passed test.
(10) After a provisioning
center receives or purchases a marihuana product in the statewide monitoring
system, a licensee may sell or transfer marihuana product only to a registered
qualifying patient or registered primary caregiver under both of the following
conditions:
(a) The marihuana product
has received passing test results in the statewide monitoring system. If the
information cannot be confirmed, the marihuana product must be tested by a
safety compliance facility and receive passing test results before sale or
transfer.
(b) The marihuana product
bears the label required for retail sale under the act and these rules.
R 333.246 Retesting. Rescinded.
Rule 46. (1) A safety
compliance facility may test or retest a sample to validate the results of a
failed safety test except as indicated under subrule (2) of this rule. A failed
safety test must include documentation detailing the initial failure and the
corrective action in the statewide monitoring system. The marihuana facility
that provided the sample is responsible for all costs involved in a retest.
(2) A failed test sample
must pass 2 separate retests consecutively to be eligible to proceed to sale or
transfer. If both retests pass, the batch is out of quarantine and eligible for
sale or transfer. If 1 or both retests fail, the marihuana product must be
destroyed as provided in these rules.
(3) A marihuana
product is prohibited from being retested in all the following circumstances:
(a) The
marihuana product is in a final package.
(b) A final test
for chemical residue failed pursuant to these rules. If the amount of chemical
residue or chemical residue active ingredient found is not permissible by the
department, the marihuana product is ineligible for retesting and the product
must be destroyed.
(c) A final
failed test for microbials on marihuana-infused product is ineligible for
retesting and the product must be destroyed.
(4) The
department 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.
R 333.247 Testing; safety compliance facility. Rescinded.
Rule 47. (1) A safety
compliance facility shall use analytical testing methodologies for the required
safety tests in subrule (2) of this rule that may be monitored on an ongoing
basis by the department or a third party, including either of the following:
(a) The most current
version of the Cannabis Inflorescence: Standards of Identity, Analysis, and
Quality Control monograph published by the American Herbal Pharmacopoeia and
adopted by reference pursuant to R 333.203.
(b) An alternative testing
methodology approved by the department and validated by an independent third
party that the methodology followed by the laboratory produces scientifically
accurate results for each safety test it conducts.
(2) A safety compliance
facility shall conduct all of the required safety tests specified in
subdivisions (a) to (h) of this subrule on the marihuana product that is part
of the harvest batch as specified in R 333.245. After the testing on the
harvest batch is completed, the department 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 that
includes all of the following:
(i) Tetrahydrocannabinol
level.
(ii) Tetrahydrocannabinol
acid level.
(iii) Cannabidiol level.
(iv) Cannabidiol acid
levels.
(b) Foreign matter
inspection.
(c) Microbial screening.
(d) Chemical residue
testing that includes all of the following:
(i) Pesticides.
(ii) Fungicides.
(iii) Insecticides.
(e) Heavy metals testing
as required in this rule.
(f) Residual solvent
levels. The department may publish a list of required residual solvents and the
action limits or levels.
(g) Water activity including
moisture content.
(h) Mycotoxin screening if
requested by the department.
(3) Except as otherwise
provided, if a sample collected pursuant to R 333.248 or provided to a safety
compliance facility pursuant to these rules does not pass the required safety
tests for water activity, microbial screening, foreign matter inspection, heavy
metals, chemical residue, and residual solvents levels based on these rules,
the marihuana facility that provided the sample shall dispose of the entire
batch from which the sample was taken and document the disposal of the sample
using the statewide monitoring system pursuant to the act, marihuana tracking
act, and these rules.
(4) For the purposes of
the microbial screening and foreign matter inspection, a sample provided to a
safety compliance facility pursuant to this rule is deemed to have passed if it
satisfies the standards in the Cannabis Inflorescence: Standards of Identity,
Analysis, and Quality Control monograph adopted by reference pursuant to R 333.203.
(5) For the purposes of
the mycotoxin testing, the department may request this testing. A marihuana sample with a value that exceeds the published
acceptable level is considered to be a failed sample. A marihuana sample that is below the acceptable value is
considered to be a passing sample.
(6) For the purposes of
the heavy metal testing, the department shall publish
a list of acceptable levels. A marihuana sample with a value that exceeds the
published acceptable level is considered to be a failed sample. A marihuana
sample that is below the acceptable value is considered to be a passing sample.
(7) For the purposes of
the residual solvent test, the department shall
publish a list of acceptable levels. A marihuana sample with a value that
exceeds the published acceptable level is considered to be a failed sample. A
marihuana sample that is below the acceptable value is considered to be a
passing sample.
(8) For the purposes of
the chemical residue test, the department shall
publish a list of acceptable levels. A marihuana sample with a value that
exceeds the published acceptable level is considered to be a failed sample. A
marihuana sample that is below the acceptable value is considered to be a
passing sample.
(9)
A safety compliance facility shall do all of the following:
(b) Become fully
accredited to the International Organization for Standardization (ISO), ISO/IEC
17025:2005 or 17025:2017 by an International Laboratory Accreditation
Cooperation (ILAC) recognized accreditation body or by an entity approved by
the department within 1 year after the date the license is issued and agree to
have the inspections and reports of the International Organization for
Standardization made available to the department.
(c) Maintain internal
standard operating procedures.
(d) Maintain a quality
control and quality assurance program that conforms to ISO/IEC 17025:2005 or
17025:2017 standards.
(10) The department shall
establish a proficiency testing program and designate safety compliance
facility participation. A safety compliance facility shall analyze proficiency
test samples using the same procedures with the same number of replicate
analyses, standards, testing analysts and equipment as used for marihuana
product testing. A safety compliance facility shall successfully analyze a set
of proficiency testing samples not less than annually. A safety compliance
facility shall submit copies of annual proficiency testing to the department
for review. All failed proficiency tests must include corrective action documentation
and an additional acceptable proficiency test. Proficiency test results must be
conveyed as numerical accuracy percentages, not simply as PASS/FAIL results.
Actual PASS/FAIL results must be calculated based on accuracy thresholds
generated by reproducibility studies specific to each assay.
(11) The department shall
publish a list of approved chemical residue active ingredients for growers to
use in the cultivation and production of marihuana plants and marihuana
products to be sold or transferred in accordance with the act or these rules.
(12) The department shall
publish a list of banned chemical residue active ingredients, the list for
acceptable action limits must meet those set forth in legal regulations for
tolerances and exemptions for chemical residues in food, 40 CFR part 180,
subpart C, or the federal insecticide fungicide, and rodenticide act, 7 USC 136
to 136y, whichever is more stringent.
(13) If a sample provided
to a safety compliance facility pursuant to this rule and R 333.248 passes the
safety tests required under subrule (2) of this rule, the safety compliance
facility shall enter the information in the statewide monitoring system of
passed test results. 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 act and these rules.
(14) A safety compliance
facility shall enter the results into the statewide monitoring system and file
with the department an electronic copy of each safety compliance facility test
result for any batch that does not pass the required tests while it transmits
those results to the facility that provided the sample. In addition, a safety
compliance facility shall maintain the test results and make them available to
the department upon request.
(15) The department shall
take immediate disciplinary action against any safety compliance facility that
fails to comply with the provisions of this rule or falsifies records related
to this rule, including any sanctions or fines, or both.
(16) A safety compliance
facility shall not do any of the following:
(a) Desiccate samples
unless performing moisture analysis on the sample.
(b) Dry label samples.
(c) Pre-test samples.
(17) A safety compliance
facility shall comply with random quality assurance compliance checks upon the
request of the department. The department or its authorized agents may collect
a random sample of a marihuana product from a safety compliance facility or
designate another safety compliance facility to collect a random sample of a
marihuana product in a secure manner to test that sample for compliance
pursuant to this rule.
(18) A safety compliance
facility may perform terpene analysis on a marihuana product using an ISO
accredited method. There are no established safety standards for this
analysis.
(19) A safety compliance
facility shall comply with the Cannabis Inflorescence: Standards of Identity,
Analysis, and Quality Control monograph published by
the American Herbal Pharmacopoeia, which is adopted by reference in R 333.203,
unless these rules provide otherwise.
R
333.248 Sampling. Rescinded.
Rule 48. (1) A safety
compliance facility shall test samples as provided in the act, the Michigan
medical marihuana act, and these rules.
(2) A safety compliance
facility shall collect samples of a marihuana product from another marihuana
facility according to the following requirements:
(a) The safety compliance
facility shall physically collect samples of a marihuana product from another
marihuana facility to be tested at the safety compliance facility. The safety
compliance facility shall ensure that samples of the marihuana product are
placed in secured, sealed containers that bear the labeling information as
required under these rules.
(b) The safety compliance
facility shall collect a sample size sufficient to complete all analyses
required, but the sample shall not be less than 0.5% of the weight of the
batch. The maximum batch size must be 15 pounds. The department may publish
recommendations for this subdivision based on the type of marihuana product
being tested.
(c) The safety compliance
facility shall enter in the statewide monitoring system the marihuana product
sample that was collected from a grower, processor, or provisioning center,
including the date and time the marihuana product is collected, transferred,
tested, and recorded.
(d) If a testing sample is
collected from a marihuana facility for testing in the statewide monitoring
system, that marihuana facility shall quarantine the marihuana product that is
undergoing the testing from any other marihuana product at the marihuana
facility. The marihuana facility shall indicate the sample being tested in the
statewide monitoring system. The quarantined marihuana product must not be
transferred or sold until testing results pass as provided under these rules.
(e) Any marihuana product
that a safety compliance facility collects for testing from a licensee under
this rule must not be transferred or sold to any other marihuana facility other
than the licensee from whom the sample was collected.
(f) A safety compliance
facility may request additional sample material from the same licensee from
which the sample was collected for the purposes of completing the required
safety tests as long as the requirements of this rule are met.
PART 5: MARIHUANA-INFUSED PRODUCTS AND EDIBLE MARIHUANA
PRODUCT
Rule 61. (1) A processor
shall prepackage and properly label marihuana-infused products before sale or
transfer.
(3) A processor of
marihuana-infused products shall list and record the THC level of
marihuana-infused products, as provided in R 333.262, in the statewide
monitoring system and indicate the THC level on the label along with the tag
identification as required under these rules. Items that are part of a product
recall issued in the statewide monitoring system, or by the department, or
other state agency, if applicable, must be immediately pulled from production
by the processor of the marihuana-infused products and not sold or transferred.
(4) Marihuana-infused
products must be stored and secured as prescribed under these rules.
(5) At a minimum, a
processor shall label any marihuana-infused product it produces or packages
with all of the following:
(a) The name and address
of the marihuana facility that processes or packages the marihuana-infused
product.
(b) The name of the
marihuana-infused product.
(c) The ingredients of the
marihuana-infused product, in descending order of predominance by weight.
(d) The net weight or net
volume of the product.
(e) For an edible
marihuana product, the processor shall comply with subdivisions (a) to (d) of
this subrule and all of the following:
(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.
(ii) If any nutritional
claim is made, appropriate labeling as specified by Code of Federal
Regulations, Food Labeling, Title 21, Part 101, 21 CFR part 101 (2017).
(iii) The following
statement printed in at least the equivalent of 11-point font size in a color
that provides a clear contrast to the background: "Made in a marihuana
facility.”
(6) A processor of edible
marihuana product shall comply with all the following to ensure safe
preparation:
(a) 21 CFR part 110. 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) Provide employee
training 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 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.
(c) A licensee, to ensure
compliance with the safe preparation standards under this subrule, shall comply
with 1 or more of the following:
(i) The
FDA food safety modernization act, 21 USC chapter 27.
(ii) Safe Quality Food
(SQF), 7.2 edition adopted by reference pursuant to R 333.203.
(iii) The International
Organization for Standardization (ISO), ISO 22000/ISO/TS 22002-1 adopted by
reference pursuant to R 333.203.
(d) The department may
request in writing documentation to verify certifications and compliance with
these rules.
(7) A processor of edible marihuana product shall comply with all the
following:
(b) No edible marihuana
product can be easily confused with commercially sold candy. The use of the
word candy or candies on the packaging or labeling is prohibited. No edible
marihuana product can be 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 simply
fruit flavored are permissible.
(c) An edible marihuana
product must be in resealable, opaque, child-resistant packages or containers that
meet the effectiveness specifications outlined in 16 CFR 1700.15.
(a) Expiration or use-by
date. A product expiration date, upon which the marihuana product is no longer
fit for consumption, or a use-by date, upon which the marihuana product is no
longer optimally fresh. Once a label with an expiration or use-by date has been
affixed to a marihuana product, a licensee shall not alter that expiration or
use-by date or affix a new label with a later expiration or use-by date.
(9) As used in this rule,
the term “edible marihuana product” means any marihuana-infused product
containing marihuana that is intended for human consumption in a manner other
than smoke inhalation.
(10) This rule does not
affect the application of any applicable local, state, or federal laws or
regulations.
R 333.262 Maximum THC levels for marihuana-infused products.
Rescinded.
Rule 62.
Marihuana-infused products processed, sold, or transferred through provisioning
centers must not exceed the maximum THC levels as established by the
department. For the purposes of maximum THC levels for marihuana-infused products,
the department shall publish a list of maximum THC concentration and serving
size limits.
R 333.271 Tracking
identification; labeling requirements; general. Rescinded.
Rule 71. (1) All marihuana
products sold or transferred between marihuana facilities must have the
tracking identification numbers that are assigned by the statewide monitoring
system affixed, tagged, or labeled and recorded, and any other information
required by the department, the act, and these rules.
(2) To ensure access to
safe sources of marihuana products, the department, if alerted in the statewide
monitoring system, may recall any marihuana products, issue safety warnings,
and require a marihuana facility to provide information material or
notifications to a registered qualifying patient or registered primary
caregiver at the point of sale.
R
333.272 Marihuana plant; tracking requirements. Rescinded.
(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, if
applicable.
(d) Seed strain, if
applicable.
(e) Universal symbol, if
applicable.
R 333.273 Marihuana product
sale or transfer; labeling and packaging requirements. Rescinded.
Rule 73. (1) Before a
marihuana product is sold or transferred to or by a provisioning center, the
container, bag, or product holding the marihuana product must have a label and
be sealed with all of the following information:
(a) The name of the
licensee and the license number of the producer, including business or trade
name, and tag or source number as assigned by the statewide monitoring system.
(b) The name of the
licensee and the license number including business or trade name of licensee
that packaged the product, if different from the processor of the marihuana
product.
(c) The unique
identification number for the package or the harvest, if applicable.
(d) Date of harvest, if
applicable.
(e) Name of strain, if
applicable.
(f) Net weight in United
States customary and metric units.
(g)
Concentration of THC and cannabidiol (CBD).
(h) Activation time
expressed in words or through a pictogram.
(i) Name of the safety
compliance facility that performed any test, any associated test batch number,
and any test analysis date.
(j) The universal symbol
for marihuana product published on the department’s website.
(k) A warning that states
all the following:
(i) "For use by
registered qualifying patients only. Keep out of reach of children."
(ii) "It is illegal
to drive a motor vehicle while under the influence of marihuana."
(iii) “National Poison
Control Center 1-800-222-1222.”
(2) An edible marihuana
product sold by a provisioning center must comply with R 333.261(7).
R
333.274 Sale or transfer; provisioning centers. Rescinded.
Rule 74. (1) A
provisioning center may sell or transfer a marihuana product to a registered
qualifying patient or a registered primary caregiver if all of the following
are met:
(a) The licensee verifies
with the statewide monitoring system that the registered qualifying patient or
a registered primary caregiver holds a valid, current, unexpired, and unrevoked
registry identification card.
(b) The licensee confirms
that the registered qualifying patient or the registered primary caregiver
presented his or her valid driver license or government-issued identification
card that bears a photographic image of the qualifying patient or primary
caregiver.
(c) The licensee
determines, if completed, any transfer or sale will not exceed the purchasing
limit prescribed in R 333.275.
(d) Any marihuana product
that is sold or transferred under this rule has been tested and is labelled and
packaged for sale or transfer in accordance with R 333.273.
(2) A provisioning center
may sell or transfer a marihuana product to a visiting qualifying patient if
all of the following are met:
(a) The licensee verifies
that 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 licensee confirms
that 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 licensee
determines, if completed, that any transfer or sale will not exceed the
purchasing limit prescribed in R 333.275.
(d) Any marihuana product
that is sold or transferred under this rule has been tested and is labelled and
packaged for sale or transfer in accordance with R 333.273.
(e) As used in this
subrule, “visiting qualifying patient” means that term as defined in section 3
of the Michigan medical marihuana act, 2008 IL 1, MCL 333.26423.
(3) A provisioning center
shall enter all transactions, current inventory, and other information required
by these rules in the statewide monitoring system in compliance with the act,
marihuana tracking act, and these rules. The provisioning center shall
maintain appropriate records of all sales or transfers under the act and these
rules and make them available to the department through its investigators,
agents, auditors, or the state police upon request.
R 333.275 Daily purchasing
limits; monthly purchasing limits; provisioning center. Rescinded.
Rule 75. (1) Before the sale or transfer of
marihuana product to a registered qualifying patient or registered primary
caregiver, the licensee shall verify in the statewide monitoring system that
the sale or transfer does not exceed either of the daily purchasing limits as
follows:
(a) For a registered
qualifying patient, an amount of marihuana product that does not, in total,
exceed 2.5 ounces per day.
(b) For a registered
primary caregiver, an amount of marihuana product that does not, in total,
exceed 2.5 ounces per day for each registered qualifying patient with whom he
or she is connected through the department’s registration process.
(2) Before the sale or
transfer of marihuana product to a registered qualifying patient or registered
primary caregiver, 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.
R 333.276 Marketing and
advertising restrictions. Rescinded.
Rule 76. (1) A marihuana
facility shall comply with all municipal ordinances, state law, and these rules
that regulate signs and advertising.
(3) A licensee shall not
advertise a marihuana product where the advertisement is visible to members of
the public from any street, sidewalk, park, or other public place. A
licensee shall not advertise or market a marihuana product to members of the public
unless the licensee has reliable evidence that no more than 30 percent of the
audience or readership for the television program, radio program, internet web
site, or print publication, is reasonably expected to be aged 17 years or
younger. Any marihuana product advertised or marketed under this rule shall
include the warnings listed in R 333.273(1)(k).
(4) A marihuana product
must be marketed or advertised as “medical marihuana” for use only by
registered qualifying patients or registered primary caregivers.
(5) A marihuana product
must not be marketed or advertised to minors aged 17 years or younger.
Sponsorships targeted to members aged 17 years or younger are prohibited.
PART 7: EMPLOYEES
R
333.281 Employees; requirements. Rescinded.
Rule 81. (1) A
licensee shall conduct a criminal history background check on any prospective
employee before hiring that individual pursuant to section 405 of the act, MCL
333.27405. A licensee shall keep records of the results of the criminal history
background checks. A licensee shall record confirmation of criminal history
background checks and make the confirmation available for inspection upon
request by the department through its investigators, agents, auditors, or the
state police.
(2) A licensee
shall comply with all of the following:
(a) Have a
policy in place that requires employees to report any new or pending charges or
convictions. If an employee is charged or convicted for a controlled
substance-related felony or any other felony, the licensee shall report it
immediately to the department.
(b) Enter in the
statewide monitoring system the 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 days.
(c) If an
employee is no longer employed by a licensee, the licensee shall remove that employee’s
access and permissions to the marihuana facility and the statewide monitoring
system.
(d) Train
employees and have an employee training manual that includes, but is not
limited to, employee safety procedures, employee guidelines, security protocol,
and educational training, including, but not limited to, marihuana product
information, dosage and purchasing limits if applicable, or educational
materials.
(e) Establish
point of sale or transfer procedures for employees at provisioning centers
performing any transfers or sales to registered qualifying patients and
registered primary caregivers. The point of sale or transfer procedures must
include, but are not limited to, training in dosage, marihuana product
information, health or educational materials, point of sale training,
purchasing limits, CBD and THC information, serving size, and consumption
information including any warnings.
(f) Screen
prospective employees against a list of excluded employees based on a report or
investigation maintained by the department.
(g) When a
registered primary caregiver is hired as an employee of a grower, processor, or
secure transporter, the licensee or the individual shall withdraw registration
as a registered primary caregiver in a manner established by the department.
(h) A licensee
shall ensure that employees handle marihuana product in compliance with current
good manufacturing process in manufacturing, packing, or holding human food, 21
CFR part 110, as specified in R. 333.233.
(3) If an
individual is present at a marihuana facility or in a secure 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 act or these rules,
the department, through its investigators, agents, auditors, or the state
police may take any action permitted under the act and these rules.
(4) Employee
records are subject to inspection or examination by the department, through its
investigators, agents, auditors, or the state police to determine compliance
with the act or these rules.
(5) Consumption
of food by employees is prohibited where marihuana product is stored, processed
or packaged or where hazardous materials are used, handled or stored unless the
marihuana facility has an employee designated area that includes, but is not
limited to, a room with floor to ceiling walls and a door that separates the
room from any marihuana product.
(6) As used in
this rule “employee” includes, but is not limited to, hourly employees,
contract employees, trainees, or any other person given any type of employee
credentials or authorized access to the marihuana facility. Trade services
provided by individuals not normally engaged in the operation of a marihuana facility,
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.
R 333.282 Provisioning
center home delivery employees; patient home delivery; limited circumstances. Rescinded.
Rule 82. (1) A provisioning
center may employ an individual to engage in the home delivery of a marihuana
product for sale or transfer to a registered qualifying patient.
(2) A provisioning center that
employs an individual under subrule (1) of this rule shall establish procedures
as specified in this rule to allow an employee of the provisioning center to
deliver a marihuana product to a patient at the patient’s home address. All of
the following procedures apply to the home delivery procedures established by a
provisioning center:
(a) For the purposes of
this rule only, a licensee may accept an online order of a marihuana product
and payment for the order that will be delivered to the home of the registered
qualifying patient as provided in this rule. An online order and payment must
be received through a secure website that authenticates access by the
registered qualifying patient. A provisioning center shall ensure that only an
authenticated and verified registered qualifying patient may view on the
provisioning center’s website a marihuana product that is available for home
delivery.
(b) The provisioning
center creates a home delivery procedure that is subject to inspection and
examination including, but not limited to, record keeping and tracking
requirements. The department may publish guidelines on the recommended
procedure.
(c) The home delivery
employee meets the requirements in R 333.281 and is an employee of the
provisioning center.
(d) Any other home
delivery procedures required in this rule.
(e) The department has
authorized the provisioning center licensee’s proposed registered qualifying
patient home delivery procedure.
(3) A provisioning center
that has received authorization under subrule (2) of this rule shall comply
with all of the following:
(a) The provisioning
center shall verify that the sale or transfer to the registered qualifying
patient is in accordance with R 333.274 and this rule. The home delivery
employee may take cash payment upon delivery and shall deliver the marihuana
product only to the physical home address of the registered qualifying patient.
(b) 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 R 333.275.
(c) The provisioning
center shall record all transactions in the statewide monitoring system as
required in the act and these rules.
(d) An employee of the
provisioning center shall make home deliveries only to a registered qualifying
patient. A home delivery employee shall verify that the person taking
delivery is the registered qualifying patient who has been recorded in the
statewide monitoring system.
(e) The authorization
granted to a provisioning center pursuant to subrule (2) of this rule may be
denied, suspended, or withdrawn by the department. The provisioning center may
be subject to other sanctions and fines as provided in the act and these rules.
(4) A provisioning center shall
maintain records of all of the following that are required to be made available
to the department through its investigators, agents, auditors, or the state
police upon request:
(a) Verification in the
statewide monitoring system that the registered qualifying patient holds a
valid, current, unexpired, and unrevoked registry identification card as
required in R 333.274 and this rule.
(b) Confirmation that the
registered qualifying patient presented his or her valid driver license or
government-issued identification card that bears a photographic image of the
patient as required in R 333.274 at the time of home delivery.
(c) Validation that the
address for home delivery of a marihuana product is the home address of the
registered qualifying patient.
(d) Documentation that the
registered qualifying patient has consented to the home delivery of marihuana
product. The consent must include an acknowledgement by the patient for the
release of information necessary in fulfilling the home delivery.
(e) Maintenance of the
following records for any motor vehicle used for home delivery and the making
of the records available to the department through its investigators, agents,
auditors, or the state police upon request: the vehicle’s make, model, color,
vehicle identification number, license plate number, and vehicle registration.
(5) A home delivery
employee shall carry a copy of all of the following information and shall make
these records available to the department through its investigators, agents,
auditors, or the state police upon request:
(a) The employee
identification number required under R 333.281.
(b) The provisioning
center licensee license number.
(c) The address of the
provisioning center licensee.
(d) Contact information of
the provisioning center licensee.
(e) A copy of the
provisioning center’s home delivery log as required in subrule (10) of this
rule.
(6) A home delivery
employee shall have access to a secure form of communication with the
provisioning center licensee, such as a cellular telephone, at all times in the
vehicle or on his or her person.
(7) To ensure the
integrity of the provisioning center operation, a home delivery employee shall
comply with all the following:
(a) During home delivery,
the home delivery employee shall maintain a physical or electronic copy of the
home delivery request and shall make the home delivery request available to the
department through its investigators, agents, auditors, or the state police
upon request.
(b) A home 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 home 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 provisioning center must be able to identify the geographic location of all
home delivery vehicles and home delivery employees who are making home
deliveries for the provisioning center and shall provide that information to
the department through its investigators, agents, auditors, or the state police
upon request.
(d) While making home
deliveries, a home delivery employee shall travel only from the provisioning
center’s licensed marihuana facility to the delivery addresses and back to the
provisioning center. A home delivery employee shall make no more than 10
registered qualifying patient home deliveries per trip before returning to the
provisioning center. A home delivery employee shall not deviate from the home
delivery limit or delivery path described in this subrule except in an
emergency that is reported to the provisioning center and documented in the
statewide monitoring system. A home delivery employee may refuel the vehicle
during a stop that is reported and documented in the statewide monitoring
system.
(e) While making home
deliveries, a home delivery employee shall not a carry marihuana product valued
in excess of the amount of the registered qualifying patient’s delivery of the
marihuana product at any time. A provisioning center shall have a procedure
subject to department approval that establishes the amount of money a home
delivery employee is allowed to have on his or her person at any 1 time during
the home delivery process. All transactions must be completed in 1 business day
and any money collected during the delivery process must be returned to the
provisioning center.
(f) A home delivery
employee of a provisioning center shall not be employed as a home delivery employee
for multiple provisioning centers.
(8) A provisioning center
shall ensure that home deliveries are completed in a timely and efficient
manner as provided on the home delivery request and log. All home deliveries
must occur within the business hours of the provisioning center. During
a home delivery, a home delivery employee shall not store a marihuana product
in a vehicle used for home deliveries other than in a secured compartment.
Marihuana product for home delivery must be packaged separately per home
delivery order and not comingled during the delivery and stored within a
secured compartment that is clearly marked, latched or locked in a manner to
keep all contents secured within.
(9) The process of home
delivery begins when the delivery employee leaves the provisioning center’s
marihuana facility with the marihuana product for delivery. The process of home
delivery ends when the delivery employee returns to the provisioning center’s
licensed marihuana facility after delivering the marihuana product to the
registered qualifying patient.
(10) A provisioning
center shall maintain a record of each delivery of a marihuana product in a
home delivery log, which may be a hard copy or electronic format, and make the
home delivery log available to the department through its investigators,
agents, auditors, or the state police upon request. For each delivery, the home
delivery log must record all of the following:
(a) The date and time that
the delivery began and ended.
(b) The name of the home
delivery employee.
(c) The amount of
marihuana product allowed to be possessed for delivery.
(d) The lot number of the
marihuana product and the name of the strain of that marihuana product.
(e) The signature of the
registered qualifying patient who accepted delivery.
(11) A provisioning center
shall notify the department, state police, or local law enforcement of any
theft, loss of marihuana product, or criminal activity as provided in R
333.216. A provisioning center shall report to the department and law
enforcement, if applicable, any other event occurring during home delivery that
violates the home delivery procedure as provided in this rule, including
delivery vehicle accidents and diversion of marihuana product.
(12) This rule does not
affect the application of any applicable local, state, or federal laws or
regulations.
PART 8.
HEARINGS
R 333.291 Definitions. Rescinded.
Rule 91. These rules use
terms as defined in R 333.201, sections 101 and 102 of the act, MCL 333.27101
and 333.27102, and sections 1 to 3 of the APA, MCL 24.201 to 24.203. In
addition, as used in this part:
(a) “Agency” means the
department, bureau, board, authority, or officer created by the constitution,
statute, or agency action.
(b) “APA” means the
administrative procedures act of 1969, 1969 PA 306, MCL 24.201 to 24.328.
(c) “Contested case
hearing” means an administrative hearing conducted by an administrative law
judge within the MAHS on behalf of the agency in accordance with MCL
333.27407(4) and 333.27302(i).
(d) “MAHS” means the
Michigan administrative hearing system within the department of licensing and
regulatory affairs.
(e) “MAHS general hearing
rules” means the administrative hearing rules promulgated by the Michigan
administrative hearing system set forth in R 792.10101 to R 792.10137 of the
Michigan administrative code.
(f) “Public investigative
hearing” means a proceeding before the medical marihuana licensing agency to
provide an applicant an opportunity to present testimony and evidence to
establish suitability for a license, in accordance with section 407(3) of the
act, MCL 333.27407.
R 333.292 Hearing
procedures; scope and construction of rules. Rescinded.
Rule 92. (1) These rules
apply to hearings under the jurisdiction of the agency involving the denial of
a license or other licensing action pursuant to section 407 of the act, MCL
333.27407 or involving complaints brought by licensees pursuant to section 302
of the act, MCL 333.27302.
(2) These rules are
construed to secure a fair, efficient, and impartial determination of the
issues presented in a manner consistent with due process.
(3) 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 APA,
MCL 24.271 to 24.287, apply.
R 333.293 Hearing on license
denial. Rescinded.
Rule 93. (1) An applicant denied a license by the agency may request a
public investigative hearing in writing within 21 days of service of notice of
the denial.
(2) After the agency
receives notice of an applicant’s request for a public investigative hearing,
the agency shall provide an opportunity for this hearing at which the applicant
may present testimony and evidence to establish suitability for a license.
(3) The agency shall
provide the applicant with written notice of the public investigative hearing
not less than 2 weeks before the hearing date. The notice must include all of
the following information:
(a) A statement
of the date, hour, place, and nature of the hearing.
(b) A statement
of the legal authority and jurisdiction under which the hearing is to be held.
(c) A short and
plain statement of the issues involved, and reference to the pertinent sections
of the act and rules involved.
(d) A short
description of the order and manner of presentation for the hearing.
(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.
(5) The agency,
or 1 or more administrative law judges designated and authorized by the agency,
shall conduct and preside over the public investigative hearing and shall 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.
(6) Upon 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 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 powers and duties under the act.
(7) During the
public investigative hearing, the applicant and the agency must be given a full
opportunity to present witnesses, ask questions or cross-examine the opposing
party’s witnesses, and present all relevant information to the agency regarding
the applicant’s eligibility and suitability for licensure.
(8) The
applicant shall at all times have the burden of establishing, by clear and
convincing evidence, its eligibility and suitability for licensure under the
act and these rules.
(9) The agency
shall record the public investigative hearing at its direction,
stenographically or by other means, to adequately ensure preservation of an
accurate record of the hearing.
(10) Following
the public investigative hearing, the matter must be considered by a quorum at
a regular or emergency meeting properly noticed in accordance to the open
meetings act, 1976 PA 267, MCL 15.261 to 15.275, at which the agency shall
decide whether to affirm, reverse, or modify in whole or in part the denial of
license.
(11) The
agency’s decision to affirm, reverse, or modify in whole or in part the denial
of license must be based on the whole record before the agency and not be
limited to testimony and evidence submitted at the public investigative
hearing, in accordance with section 407(3) of the act, MCL 333.27407.
(12) The
agency’s decision to affirm, reverse, or modify in whole or in part the denial
of license must be reduced to writing and served upon the applicant and agency
within a reasonable time.
R 333.294 Review of
licensing action. Rescinded.
Rule 94. (1) A licensee
who has been notified of a license violation, or of the agency’s intent to
suspend, revoke, restrict, or refuse to renew a license or impose a fine, may
be given an opportunity to show compliance with the requirements before the
agency taking action as prescribed by the act or these rules.
(2) A licensee aggrieved
by an action of the agency to suspend, revoke, restrict, or refuse to renew a
license, or to impose a fine, may request a contested case hearing in writing
within 21 days after service of notice of the intended action.
(3) Upon 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 APA, MCL
24.271 to 24.287, and the MAHS general hearing rules.
(4) The contested case
hearing must be conducted by an administrative law judge or judges within the
MAHS.
(5) Upon timely request
of the licensee or the agency in accordance with the Michigan court rules,
an assigned administrative law judge may issue 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 powers and duties under
the act.
(6) 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 license, or to impose a fine, or summarily suspend a license.
R 333.295 Summary
suspension. Rescinded.
Rule 95. (1) If
the agency summarily suspends a license under section 407(2) of the act, MCL
333.27407, without notice or hearing upon a determination that the safety or health
of patrons or employees is jeopardized by continuing a marihuana facility’s
operation, a post-suspension hearing must be held promptly to determine if the
suspension should remain in effect, in accordance with section 92 of the APA,
MCL 24.292, and the MAHS general hearing rules.
(2) 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 employees is jeopardized by
continuing a marihuana facility’s operation.
(3) Immediately
after the post-suspension hearing, the administrative law judge assigned to
hear the matter shall issue a written order granting or denying dissolution of
the summary suspension.
(4) 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 a marihuana facility’s operation and continue the
order of summary suspension.
(5) The record
created at the post-suspension hearing becomes a part of the record at any
subsequent hearing in the contested case.
R 333.296 Complaint by
licensee. Rescinded.
Rule 96. (1) A
licensee may file a written complaint with the agency regarding any
investigative procedures of this state that he or she believes to be
unnecessarily disruptive of marihuana facility operations, as provided in
section 302 of the act, MCL 333.27302.
(2) The agency
may delegate to a subcommittee of the agency the authority to hear, review, or
rule on a licensee complaint.
(3) The agency
or its subcommittee may delegate authority to an administrative law judge to
hear a licensee’s complaint as a contested case in accordance with sections 71
to 79 of the APA, MCL 24.271 to 24.279, and the MAHS general hearing rules.
(4) As the
complaining party, a licensee has the burden of proving by a preponderance of
the evidence that the investigative procedures of this state unreasonably
disrupted its marihuana facility operations.
R 333.297 Proposal for
decision. Rescinded.
Rule 97. Following an
opportunity for a public investigative hearing or contested case hearing and
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 24.281.
R 333.298 Final order. Rescinded.
Rule 98. (1) The
agency 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 upon the licensee within a
reasonable time.
(3) The review
decision or order of the agency following an opportunity for 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 24.306.
PART 9:
SUNSET
R 333.299 Sunset. Rescinded.
Rule 99. These
rules expire 2 years after the date of filing unless this provision is
rescinded.