New Mexico Register / Volume XXXIII,
Issue 13 / July 12, 2022
This is an
amendment to 16.8.2 NMAC replacing and Section 56 and adding Sections 57, 58,
59, 60, 61, 62 and 63 effective 07/12/2022.
16.8.2.56 CANNABIS RESEARCH LABORATORY LICENSURE; GENERAL PROVISIONS:
A. License Types: The division may license
three classes of research:
(1) Tier I: A
cannabis research laboratory
Tier I may produce
cannabis to be ingested by human or animal subjects, or produce
cannabis not meant for ingestion, for division approved clinical, agricultural, or market research
studies; produce federally legal cannabis
products; and may conduct division approved
clinical, agricultural, or market research studies;
(2) Tier II: A
cannabis research
laboratory Tier II may produce
cannabis not meant for ingestion, or purchase cannabis to be ingested by human or animal subjects, for division approved clinical, agricultural,
or
market research studies; and
may conduct division approved clinical, agricultural, or market research
studies
(3) Tier III: A
cannabis research laboratory Tier III may
not produce
cannabis and may only purchase cannabis
or cannabis
products from licensed cannabis research laboratories
Tier I and Tier II, as appropriate for approved
clinical, agricultural, or market research studies; and may
conduct clinical, agricultural, or market research
studies.
B. A Tier II or Tier III cannabis research laboratory may purchase cannabis
from
another licensed
cannabis establishment with
approval from the
cannabis control division only
if
such research relates to brand specific
inquiries (e.g.,
including studies
comparing similar products from different brands
or
conducting cultivar
specific efficacy studies for certain conditions) where
use of cannabis
or cannabis products produced
by a cannabis research laboratory is impossible.
C. Except
as noted in subsection (B), a cannabis research laboratory license permits a
licensee to produce, process, transport, transfer, sell and possess cannabis
consistent with its license type for research and related purposes.
D. A cannabis
research laboratory may also produce and distribute federally legal cannabis
products as authorized by state and federal law pertaining to drug products.
E. A cannabis
research laboratory will provide notice to the cannabis control division prior
to commencing the production and distribution of any federally legal cannabis
product, including evidence of federal authorizations.
F. All applications
for
licensure authorized
pursuant to the Cannabis
Regulation Act shall be made
upon current forms prescribed
by the division.
[16.8.2.56
NMAC – Rp 16.8.2.56 NMAC, 07/12/2022]
16.8.2.57 APPLICATION REQUIREMENTSFOR
CANNABIS RESEARCH LABORATORY LICENSE:
A. An initial
application or renewal for cannabis research laboratory licensure shall include
the following:
(1) Business
and controlling person(s) contact information, to include:
(a) legal business name, including
DBA if applicable
(b) type
of business entity;
(c) business
mailing address;
(d) business telephone number;
(e) business
email address;
(f) business
physical address, if different;
(g) business
web address, if applicable;
(h) business
hours of operation;
(i) name
and contact information for each controlling person;
(j) demographic
data pursuant to the Cannabis Regulation Act; and
(k) license
type sought (Tier I, Tier II, or Tier III);
(2) proof
each controlling person is at least 21 years of age, which shall include
identification issued by a federal or state government that includes the name,
date of birth, and picture of controlling person;
(3) if
applicable, certification the applicant is in good standing with the New Mexico
secretary of state;
(4) a
list of other current or prior licensed cannabis businesses;
(5) a
list of other names used by controlling person(s);
(6) name and contact information
for the primary controlling person for the business or an authorized
representative of the business if not a controlling person;
(7) criminal
history screening documents as set forth in 16.8.2.9 NMAC and the Cannabis
Regulation Act;
(8) a
detailed description of any criminal convictions of the applicant and any
controlling person, including the date of each conviction, dates of
incarceration, probation or parole, if applicable, description of the offense,
and statement of rehabilitation of each conviction;
(9) if applicable, a detailed research
plan, including but not limited to the applicant’s plan for recruiting research
subjects, producing or acquiring cannabis, dispensing cannabis, plans for
continuing research, and the forms of usable cannabis and cannabis-derived
products to be examined;
if
applicable, a detailed description of any private or public partnerships with
higher education institutions, other cannabis research laboratories, or private
business;
(10) if applicable, drug enforcement
administration license to conduct research;
(11) if
applicable, proof of prior approval by the New Mexico regulation and licensing
department for the use of any compressed gas extraction equipment to be
utilized by the manufacturer;
(12) if
applicable, the applicant’s DEA license or any conditional approval from the
DEA to bulk manufacture cannabis for research, or the applicant’s plan for
seeking such licensure in the future;
(13) certification
the applicant will not use dimethylsulfoxide (DMSO)
in the production of cannabis derived products, and will not possess DMSO on
the premises of the licensee;
(14) evidence
that the applicant has obtained all necessary permits required for the production of edible and topical cannabis products
from the New Mexico environment department and that such permits are valid at
the time the license application is submitted
(15) certification
the applicant will adhere to cannabis transport requirements pursuant to the
Cannabis Regulation Act, the Lynn and Erin Compassionate Use Act, or division rules;
(16) certification
the applicant will adhere to security requirements pursuant to the Cannabis
Regulation Act, the Lynn and Erin Compassionate Use Act, or division rules;
(17) certification
the applicant will adhere to applicable federal, state and local laws governing
the protection of public health and the environment, including occupational
health and safety, food safety, fire safety, environmental impacts, natural
resource protections, air quality, solid and hazardous waste management, and
wastewater discharge;
(18) certification
the applicant has never been denied a license or had a license suspended or revoked
by the division or any other state cannabis licensing authority or a detailed
description of any administrative orders, civil judgements, denial or
suspension of a cannabis license, revocation of a cannabis license, or
sanctions for unlicensed cannabis activity by any state licensing authority,
against the applicant, controlling person, or a business entity in which the
applicant or controlling person was a controlling person within the three years
immediately preceding the date of the application;
(19) certification
the applicant will adhere to production and manufacturing requirements pursuant
to the Cannabis Regulation Act, the Lynn and Erin Compassionate Use Act, or
division rules, including creating and maintaining a cultivation plan, and cannabis
waste procedures for cannabis products;
(20) certification
the applicant will adhere to New Mexico department of agriculture (NMDA)
pesticide registration, licensing, and use requirements to ensure a safe
product and environment;
(21) applicant’s
social and economic equity plan to encourage economic and social diversity in
employment, including race, ethnicity, gender, age, and residential status of
licensee, controlling persons and employees of applicant and whether the
applicant, controlling persons, employees or the locations where the cannabis
products are produced are located in an underserved rural community, including
tribal, acequia, land grantmerced, federally
designated opportunity zone, or other rural historic communities;
(22) an
attestation by a person authorized to act on behalf of the business of the
following statement: Under penalty of perjury, I hereby declare that the
information contained within and submitted with the application is complete, true and accurate. I understand that a misrepresentation of
fact or violation of these rules may result in denial of the license
application or revocation of a license issued; and
(23) payment
of any required fees as set forth in 16.8.11 NMAC.
B. Verification of
information: The division may verify information contained in each application
and accompanying documentation by:
(1) contacting
the applicant or controlling person by telephone, mail, or electronic mail;
(2) conducting
an on-site visit;
(3) requiring
a face-to-face or virtual meeting and the production of additional
documentation; or
(4) consulting
with state or local governments.
C. Trade secrets:
Any applicant submitting operating procedures and protocols to the division
pursuant to the Lynn and Erin Compassionate Use Act, the Cannabis Regulation
Act, or division rules, may claim such information as a trade secret or
confidential by clearly identifying such information as “confidential” on the
document at the time of submission. Any claim of confidentiality by an applicant
must be based on the applicant’s good faith belief that the information marked
as confidential constitutes a trade secret as defined in the Uniform Trade
Secrets Act, Sections 57-3A-1 to -7, NMSA 1978. In the event the division
receives a request to inspect such documents, the division will notify the
applicant or licensee, via the current email of record. If the division does
not receive an injunction pursuant to the Uniform Trade Secrets Act within 10
days of the request to inspect, the division will make the documents marked
confidential available for inspection as required pursuant to the Inspection of
Public Records Act.
[16.8.2.57
NMAC – N, 07/12/2022]
16.8.2.58 SUBMITTAL OF APPLICATION FOR
AMENDED CANNABIS RESEARCH LABORATORY LICENSE:
A. Application: A
licensed research laboratory shall submit to the division an application form
for an amended license, if applicable and obtain approval from the division,
prior to implementing any of the following:
(1) material
or substantial change of the size or location of the premises;
(2) change
of licensee’s legal or business name;
(3) change
or modification in extraction type(s) or equipment;
(4) material
or substantial change in water source;
(5) addition
or elimination of a controlling person;
(6) material
or substantial change to a license’s security system; or
(7) material
or substantial modification of the premise.
B. Amended license not
required: Changes to standard operating policies and procedures may be made
without providing notification to the division, provided that
licensees shall maintain at each licensed premises a copy of all current and
prior operating policies and procedures.
C. Requirements and
processing of application for amended license: The application for amended
license must comply with all requirements applicable to initial applications,
except that the application shall be clearly designated as one for an amended license.
The division shall approve or deny an application for amended license within 90
days of receiving a completed application. Denial of an application for
amendment shall be pursuant to the Uniform Licensing Act.
D. Material
or substantial change: Material or substantial changes requiring approval
include:
(1) increase
or decrease in the size of the premises, including the sale of property used
for the cannabis establishment, the purchase of additional property for the use
of the cannabis establishment, or a change in the location of the cannabis establishment;
(2) a
modification in the licensee’s access to the water source submitted with an
application for initial or renewal licensure or a ten percent, or more,
increase in the licensee’s water usage;
(3) change
to a license’s security system, including relocation or security points or
installation of a new security system; or
(4) modification
of the premises to relocate cannabis activities.
[16.8.2.58
NMAC – N, 07/12/2022]
16.8.2.59 EXPEDITED
APPROVAL PROCESS: The division shall create an early approval
process for entities that are either registered or conditionally approved by
the FDA to manufacture bulk cannabis for research or to research cannabis.
A. Any entity conditionally approved for or holding a valid
DEA registration as enumerated below may, within 60 days of the effective date,
apply to the cannabis control division for expedited approval as follows:
(1) An entity that is registered with or
conditionally approved by the DEA to manufacture bulk cannabis for research may
seek early approval for a Tier I License; or
(2) An entity that is registered with or
conditionally approved by the DEA to research cannabis may seek early approval
for a Tier III license.
B. If an applicant meets all the relevant requirements of
this section, the division shall issue the research laboratory license within
30 days of receiving a completed application.
[16.8.2.59 NMAC –
N, 07/12/2022]
16.8.2.60 PREMISES DIAGRAM:
All licensees shall have a
detailed diagram of the premises on hand at all times and made available
for in person inspection by the Division or its agents upon request. This premises diagram shall conform to the
requirements set forth in 16.8.2 NMAC.
[16.8.2.60
NMAC – N, 07/12/2022]
16.8.2.61 CANNABIS RESEARCH LABORATORY
POLICIES AND PROCEDURES:
A. Minimum policy
and procedure requirements: Licensees shall develop, implement, and maintain on
the licensed premises, standard policies and
procedures, which shall include the following:
(1) cannabis
research criteria and procedures, which shall be consistent with the
requirements of applicable state laws, including the Cannabis Regulation Act,
the Lynn and Erin Compassionate Use Act, division rules, and shall include at a
minimum, the following topics:
(2) protocols
for research;
(3) recordkeeping
and chain of custody protocols for transportation of cannabis or cannabis
product; and procedures for testing and destruction of cannabis or cannabis products;
(4) employee
policies and procedures to address the following minimum requirements:
(5) adherence
to state and federal laws;
(6) responding
to an emergency, including robbery or a serious accident or incident;
(7) alcohol
and drug-free workplace policies and procedures;
(8) safety
and security procedures;
(9) occupational
health and safety;
(10) crime
prevention techniques; and
(11) if
applicable, confidentiality laws, including the Health Insurance Portability
and Accountability Act of 1996; and
(12) statements
signed by employees indicating receipt and understanding of policies and
procedures.
B. Training
program: Licensee shall implement a training program, approved by the division,
to ensure that all personnel present at the premises are provided information and
training that, at minimum, covers the following topics within 30 days of the
start of employment:
(1) employee
health and safety;
(2) health
and safety hazards;
(3) hazard
communication for all solvents or chemicals used at the licensed premises and
as described in the safety data sheet for each solvent or chemical;
(4) requirements
for the proper use of health and safety measures and controls;
(5) emergency
procedures;
(6) security
procedures; and
(7) record
keeping requirements.
C. A licensee, or
employee, involved in the handling, transportation, manufacture, extraction,
testing, or packaging of cannabis products must successfully complete a food
handler course accredited by the American national standards institute (ANSI)
prior to conducting any related activities. Such training shall be maintained
while employed under a cannabis research licensee. The licensee shall obtain
documentation evidencing the fulfillment of this requirement.
D. Training
documentation:
(1) Licensee
shall ensure that all personnel receive annual refresher training to cover, at
minimum, the topics listed in this section.
(2) The
licensee shall maintain a record, which contains at minimum:
(a) duties
of each personnel;
(b) a
list of all personnel at the premises, including at minimum, name and job title;
(3) documentation
of training topics and dates of training completion;
(4) the
signature of each employee verifying receipt and understanding of each training
or refresher training completed.
E. Retention of
training documentation: Licensees shall maintain documentation of an employee’s
training for a period of two years for current employees and at least six
months after the termination of an employee’s employment.
[16.8.2.61
NMAC – N, 07/12/2022]
16.8.2.62 HUMAN SUBJECT PROTECTIONS:
A. Before conducting research involving human
subjects, the licensee shall:
(1) provide the division with
documentation that the study has received institutional review board (IRB)
approval, as defined and described in 45 CFR Part 46,
federal policy for the protection of human subjects; and
(2) obtain “informed
consent,” as defined and described in 45 CFR Part 46, federal policy for the
protection of human subjects, from the human research subject.
B. Nothing in this part relieves the licensee
from complying with applicable FDA and state requirements governing cannabis
research.
[16.8.2.62
NMAC – N, 07/12/2022]
[16.8.2.56]
16.8.2.63 SEVERABILITY: If any part or application of this rule is held to be invalid, the remainder or its application to other situations or persons
shall not be affected. Any section of this rule legally
severed shall not interfere with the remaining protections and duties provided by this rule.
[16.8.2.63
NMAC – Rn, 16.8.2.43 NMAC, 01/11/2022; Rn, 16.8.2.56 NMAC, 07/12/2022]
History of 16.8.2
NMAC: [RESERVED]