Current through Register Vol. 35, No. 6, March 26, 2024
A laboratory applicant shall comply with the application
requirements of this rule, and shall submit such other information as the
laboratory applicant wishes to provide or such information as the department
may request for initial approval and periodic evaluations during the approval
period.
A.
Testing
categories: A laboratory may apply to become approved by the department
as an approved laboratory for the testing of cannabis and cannabis derived
products in all or any one of the following categories:
(1) mycotoxin analysis;
(2) microbiological contaminant
analysis;
(3) solvent residue
analysis;
(4) quantity of THC and
CBD; and
(5) such other testing
categories as the department may identify.
B.
Fee: A laboratory applicant
shall submit to the program with each initial application and renewal
application for continued approval a non-refundable application fee of
two-thousand-two-hundred dollars ($2,200), payable to the medical cannabis
program.
C.
Application
materials: A laboratory applicant shall submit to the program with each
initial application and renewal application for continued approval the
following:
(1) standard operating procedures
to be followed by the laboratory, including but not limited to policies and
procedures to be used in performing analysis of samples;
(2) a description of the type of tests to be
conducted by the laboratory applicant, which may include, but are not limited
to, testing for microbiological contaminants, mycotoxins, solvent residue, THC
content, CBD content, identity, purity, strength, composition, or nutritional
content, and other quality factors;
(3) quality control criteria for the test(s)
that the applicant intends to conduct;
(4) evidence that validates the accuracy of
the test(s) to be conducted by the laboratory applicant as performed in the
applicant's laboratory;
(5) proof
that the laboratory applicant is in good standing with the New Mexico taxation
and revenue department;
(6) copies
of the laboratory applicant articles of incorporation and by-laws, as
applicable;
(7) a list of all
persons or business entities having direct or indirect authority over the
management or policies of the laboratory applicant;
(8) a list of all persons or business
entities having any ownership interest in any property utilized by the
laboratory applicant, whether direct or indirect, and whether the interest is
in land, building(s), or other material, including owners of any business
entity that owns all or part of land or building(s) utilized;
(9) a description of the facilities and
equipment that shall be used in the operation of the laboratory
applicant;
(10) a description of
how the laboratory applicant will ensure and document chain of custody of any
samples held or tested by the laboratory;
(11) a general written security policy, to
address at a minimum safety and security procedures;
(12) an attestation that no firearms will be
permitted on any premises used by the laboratory applicant;
(13) a description of the methods and device
or series of devices that shall be used to provide security;
(14) training documentation prepared for each
employee of the laboratory applicant, statements signed by employees indicating
the topics discussed (to include names and titles of presenters) and the date,
time, and place the employee received said training;
(15) personnel records for each employee of
the laboratory applicant that include an application for employment and a
record of any disciplinary action taken;
(16) employee safety and security training
materials provided to each employee of the laboratory applicant at the time of
his or her initial appointment, to include training in the proper use of
security measures and controls that have been adopted, and specific procedural
instructions regarding how to respond to an emergency, including robbery or a
violent accident;
(17) documented
proof of required initial and continuing demonstrations of capability, in
accordance with this rule;
(18)
proof that no buildings to be used by the applicant are located within 300 feet
of any school, church, or daycare center; or alternatively, proof that any
school, church, or daycare center that is located within 300 feet of a building
to be used by the applicant did not occupy that location prior to the applicant
initially seeking to become licensed to operate at the location;
(19) an attestation that the laboratory will
not operate in any location within 300 feet of a school, church or daycare
center; and
(20) such other
materials as the department may require.
D.
Materials to be maintained on
premises: An approved laboratory shall maintain on its premises, and
shall promptly present to the department upon request:
(1) personnel documentation including, but
not limited to employment records, job descriptions, education, and training
requirements of the laboratory, and documentation of education and training
provided to staff for the purpose of performance of assigned
functions;
(2) requirements
concerning laboratory operations, business licensing, and security
procedures;
(3) standards for
receipt, handling, and disposition of samples of usable cannabis;
(4) equipment information detailing the type
of equipment used, inspection standards and practices, testing and calibration
schedules and records, and standards for cleaning and maintenance of
equipment;
(5) reagents, solutions,
and reference standards including, but not limited to standards for labeling,
storage, expiration, and re-qualification dates and records;
(6) reference standards, acquired or
internally produced, including the certificate of analysis;
(7) sample analysis procedures including but
not limited to procedures for the use of only primary or secondary standards
for quantitative analyses;
(8)
documentation demonstrating that the analytical methods used by the laboratory
are appropriate for their intended purpose; that staff is proficient in the
process; and that deviations from approved standards of practice do not occur
without proper authorization;
(9)
standards for data recording, review, storage, and reporting that include, but
are not limited to standards to ensure:
(a)
that data is recorded in a manner consistent with this rule, and that it is
reviewed to verify that applicable standards of practice, equipment
calibration, and reference standards were applied before reporting;
(b) that all data, including raw data,
documentation, protocols, and reports are retained in accordance with the
requirements of this rule; and
(c)
that reports are the property of the business or individual who provided the
sample, and reports meet the requirements of this rule.
(10) current material safety data sheets for
all chemicals used; and
(11) such
other materials as the department may require.
E.
Proficiency testing and inspection:
(1) A laboratory applicant shall be
subject to proficiency testing by the department or its designee prior to
approval, and an approved laboratory shall be subject to proficiency testing,
at a frequency and at times to be determined by the program director or
designee. A laboratory applicant or approved laboratory shall cooperate with
the department or its designee for purposes of conducting proficiency testing.
The department or its designee may require submission of cannabis and
cannabis-derived product samples from licensed non-profit producers and
approved manufacturers for purposes of proficiency testing.
(2) A laboratory applicant and an approved
laboratory shall be subject to inspection(s), at times determined by the
program director or designee, in accordance with the provisions of this rule.
The department may require the inspection of premises, equipment, and written
materials to determine compliance with this rule, and to determine compliance
with the application submissions of the laboratory applicant or approved
laboratory, including but not limited to standard operating procedures and
standards for testing.
(3)
Failure of proficiency testing: If the department determines on the
basis of a proficiency test that a laboratory applicant has not satisfactorily
identified the presence, quantity, or other relevant factor(s) pertaining to a
given analyte, the department may deny the application in whole or in part,
require additional tests, or require remedial actions to be taken by the
laboratory applicant. If the department determines on the basis of a
proficiency test that an approved laboratory has not satisfactorily identified
the presence, quantity, or other relevant factor(s) pertaining to a given
analyte, the department may withdraw approval of the laboratory in whole or in
part, require additional tests, or require remedial actions to be taken by the
approved laboratory.
F.
Retention and inspection of testing records: An approved
laboratory shall retain all results of laboratory tests conducted on cannabis
or cannabis derived products for a period of at least two years and shall make
them available to the program upon the program's request.
G.
Identification cards: An
employee of an approved laboratory shall carry their department issued employee
identification card at all times during their work, and shall present the card
to law enforcement officials and to department officials upon request. An
employee who is unable to produce their department issued identification card
upon request shall not remain on the licensed premises, and shall produce the
card for the department's inspection prior to returning to the licensed
premises. Identification cards issued by the department are the property of the
department and shall be returned to the department upon the termination of the
holder's employment with the approved laboratory, upon suspension, or
revocation, or upon demand of the department.
H.
Reporting of theft to
department: A laboratory shall submit to the department notification of
any theft, robbery, break-in, or security breach that occurs on the
laboratory's premises, no later than 10 calendar days after the laboratory
first becomes aware of the event. The description shall include a description
of any property that was stolen or destroyed, and the quantity of any usable
cannabis that was stolen.
I.
Term of approval: Department approval of a laboratory for purposes of
this rule shall be for a term of one year, and shall expire after that year, or
upon closure of the approved laboratory. An approved laboratory shall apply for
renewal of approval annually no later than 60 days prior to
expiration.
J.
Amended
license:
(1) An approved laboratory
shall submit to the department an application form for an amended license, and
shall obtain approval from the department, at least 30 business days prior to
implementing any:
(a) change of location of
the laboratory's facilities, change of directors, change of ownership of the
laboratory's facilities, change of company name, and any physical modification
or addition to the laboratory's facilities; and
(b) substantial change to the laboratory's
standard operating procedures or substantial change to the types of tests to be
conducted.
(2)
Process for incomplete application for amended license: In the
event that an application for amended licensure is determined by the program to
be incomplete, the program will specify the information or materials that
remain to be submitted. If the laboratory does not submit the requested
information or material, and does not otherwise contact the department
regarding the application, within thirty days of receiving notice of the
deficiency, the application will be closed as incomplete, and the laboratory
will be required to resubmit the application in order to recommence the
application process.
K.
Termination: The department may deny, withdraw, or suspend
approval of a laboratory in accordance with this rule, upon determination by
the department that the laboratory has violated a provision of this rule, upon
failure of a proficiency test, upon the refusal of the laboratory to provide
requested access to premises or materials, or upon the failure of a laboratory
to comply with any standard, procedure, or protocol developed, submitted, or
maintained pursuant to this rule.
