Current through Register Vol. 35, No. 18, September 24, 2024
A.
General requirements:
Cannabis testing laboratories shall ensure the following:
(1) testing is done in premises that are in
compliance with state and local laws that do not conflict with the Cannabis
Regulation Act or the Lynn and Erin Compassionate Use Act; and
(2) weighting or measuring devices that are
used in testing are appropriately documented as having undergone certified
registration and calibration that is in accordance with requirements of the New
Mexico department of agriculture applicable to commercial
transactions.
B.
Sample collection: For all required testing or testing for the
purposes of labeling claims, a person authorized by this rule shall collect the
required samples according to the following guidelines:
(1) Only the quantity of cannabis product
specified in the cannabis testing laboratory's operating procedures as
necessary for all tests to be performed and to ensure the proper number of
representative samples shall be collected.
(2) The number of sample increments per
batch, as specified in the cannabis testing laboratory's operating procedures
as necessary for all tests to be performed, shall be collected.
(a) The number of sample increments shall not
be less than the minimum quantity specified in Table 2.
(b) Samples shall be taken randomly
throughout the length, width, and depth of the batch.
(c) The standard sample increment size shall
be 0.5 grams, unless specified otherwise in the cannabis testing laboratory's
operating procedures.
(3)
Samples from the same batch shall be secured in a single use, tamper-evident
container that meets the specifications of the laboratory's policies and
procedures.
(4) Samples shall be
labeled according to the laboratory's policies and procedures, with, at
minimum:
(a) the license number of the
establishment from which the sample was collected;
(b) the batch number assigned by the
establishment;
(c) the date the
sample was taken;
(d) the name of
the person collecting the sample; and
(e) the tests to be performed;
(5) If homogeneity testing is
required, each sample increment necessary for homogeneity testing shall be
collected and transported in individual sealed containers.
Table 1. Minimum quantity of
sample increments
|
Matrix Type
|
Batch Size
|
Minimum Sample Increments
|
Dried cannabis
|
<=5.0 lbs.
|
10
|
>5.0 lbs.; <=15.0 lbs.
|
10 + 5 per pound or fraction thereof above 5
pounds
|
Other products
|
<=2.0 lbs.
|
10
|
>2.0 lbs.
|
5 per pound
|
C.
Transportation: All samples
shall be transported according to the general requirements of
16.8.2.13
NMAC and the specifications found in the cannabis testing laboratory's policies
and procedures.
D.
Receipt of
test samples: A cannabis testing laboratory may receive test samples of
cannabis products from any cannabis establishment, adult 21 years of age or
older, qualified patient, or primary caregiver as authorized by this
rule.
E.
Storage: A
cannabis testing laboratory shall segregate and store cannabis samples in a
manner that prevents contamination or degradations and shall safeguard any
cannabis products and cannabis waste against diversion.
(1) A cannabis testing laboratory shall
provide one or more secure cabinets or vaults for the storage of cannabis
samples, reference standards, and cannabis waste, and access shall be limited
to persons authorized to conduct tests or dispose of cannabis waste.
(2) Cannabis samples shall be stored in
environmental conditions that minimize physical or chemical degradation and
microbial contamination, including protection from light, heat, and humidity.
Any cannabis product that requires refrigeration shall be kept at a temperature
no greater than 40 degrees Fahrenheit (4 degrees Celsius) prior to sample
preparation.
F.
Sample retention and disposal:
(1) Samples testing positive for a prohibited
pesticide must be retained for a minimum of 30 days. All other samples must be
retained for a minimum of 15 days. Upon notification from the division that
samples are needed for an investigation by the division, a law enforcement
agency, or another department, the cannabis testing laboratory shall retain the
sample until further directed by the division.
(2) Any portion of a cannabis or
cannabis-derived test sample that is not destroyed during analysis shall be:
(a) returned to the person who provided the
sample;
(b) provided to the
division, the state chemist laboratory (department of agriculture), or state
laboratory division for additional testing;
(c) upon written notification to the
department, used to make for internal quality control purposes; or
(d) destroyed in accordance with the wastage
requirements of this rule.
G.
Laboratory premises: A
cannabis testing laboratory shall maintain the premises of the laboratory in a
clean and orderly condition; shall equip the premises with such utensils and
equipment as necessary to conduct the operations of the laboratory; and shall
ensure adequate space for laboratory operations, sample storage, and document
storage.
H.
Equipment:
(1) Equipment used for the analysis of test
samples shall be adequately inspected, cleaned, and maintained by laboratory
staff, the manufacturer, or other trained persons according to manufacturer
recommendations. Equipment used for the generation or measurement of data shall
be adequately tested and calibrated on an appropriate schedule, as applicable.
(2) Laboratory operations shall
document procedures setting forth in sufficient detail the methods and
schedules to be used in the routine inspection, cleaning, maintenance, testing,
and calibration of equipment, and shall specify, as appropriate, remedial
action to be taken in the event of failure or malfunction of equipment. The
procedures shall designate the personnel responsible for the performance of
each operation.
(3) Computer
systems used for the analysis of samples, retention of data, sample tracking,
calibration scheduling, management of reference standards, or other critical
laboratory management functions shall ensure that electronic records,
electronic signatures, and handwritten signatures executed to electronic
records are trustworthy, reliable, and generally equivalent to paper records
and handwritten signatures executed on paper.
I.
Reagents, solutions, and reference
standards:
(1) A cannabis testing
laboratory is authorized to possess reagents, solutions, and reference
standards. Such items shall be:
(a) secured
in accordance with the approved laboratory's storage policies;
(b) labeled to indicate identity, date
received or prepared, and expiration or requalification date; and, where
applicable, concentration or purity, storage requirements, and date
opened;
(c) stored under
appropriate conditions to minimize degradation or deterioration of the
material; and
(d) used only within
the item's expiration or requalification date.
(2) Deteriorated or outdated reagents and
solutions shall be properly destroyed.
(3) A cannabis testing laboratory may:
(a) acquire commercial reference standards
for cannabinoids and other chemicals or contaminants, for the exclusive purpose
of conducting testing for which the laboratory is approved;
(b) internally produce reference standards,
using standard analytical techniques to document the purity and concentration
of the internally produced reference standards;
(c) obtain cannabis products from a cannabis
establishment for the purpose of producing reference standards.
J.
Recording of
analytical data:
(1) A cannabis
testing laboratory shall ensure that all data generated during the testing of a
test sample, except data generated by automated data collection systems, is
recorded directly, promptly, and legibly in ink.
(2) When automated data collection systems
are used, the cannabis testing laboratory shall log the name of the individual
performing the test.
(3) All data
shall be annotated with the date of entry and signed or initialed by the person
recording the data. Any change in entries shall be made so as not to obscure
the original entry, shall indicate the reason for such change, and shall be
dated and signed or initialed at the time of the change.
(4) Any change in an entry shall:
(a) be made so as not to obscure the original
entry;
(b) indicate the reason for
such change;
(c) be dated and
signed or initialed at the time of the change; and
(d) be accompanied by a corrective action
report to be made available to the division or the cannabis establishment that
submitted the sample upon request for up to two years after the analysis is
completed.
(5) For each
final result reported, a cannabis testing laboratory shall verify that:
(a) any calculations or other data processing
steps were performed correctly;
(b)
the data meet any data quality requirements such as for accuracy, precision,
linearity, etc.;
(c) any reference
standards used were of the appropriate purity and within their expiration or
requalification dates;
(d) any
volumetric solutions were properly standardized before use; and
(e) any test or measuring equipment used has
been properly tested, verified, and calibrated, and is within its verification
or calibration period.
K.
Data storage:
(1) A cannabis testing laboratory shall
ensure that all raw data, documentation, protocols, and certificates of
analysis associated with analysis of a test sample are retained for two years
from the date of the completion of analysis.
(2) A cannabis testing laboratory shall
designate an individual as responsible for records maintenance;
(3) A cannabis testing laboratory shall
maintain the records identified in this section. Such records must be
maintained:
(a) in a manner that allows
retrieval as needed;
(b) under
conditions of storage that minimize deterioration throughout the retention
period; and
(c) in a manner that
prevents unauthorized alteration.
(4) Only authorized personnel may access the
records.
L.
Data
reporting:
(1) A certificate of
analysis shall contain the following information:
(a) the date of receipt of the test
sample;
(b) the description of the
type or form of the test sample (leaf, flower, powder, oil, specific edible
product, etc.);
(c) the batch
number or code that is associated with the product batch and that is recorded
in the track and trace system;
(d)
the identity of the person who collected the sample;
(e) the date on which analysis
occurred;
(f) the analytical method
used, including at a minimum identification of the type of analytical equipment
used (e.g., GC, HPLC, etc.);
(g)
the analytical results, including units of measure where applicable;
(h) the identity of the supervisory or
management personnel who reviewed and verified the data and results and ensured
that data quality, calibration, and other applicable requirements were met;
and
(i) the name, address, and
contact information of the cannabis testing laboratory that conducted the test.
(2) The certificate of
analysis shall state that reported analytical results apply only to the test
sample received.
(3) The
certificate of analysis shall contain in minimum 12-point type, all capital
letters, the disclaimer, "UNOFFICIAL TEST RESULTS. NOT VALID FOR TRANSFER OR
SALE" whenever:
(a) The person submitting the
test sample is not a licensed cannabis establishment;
(b) The test sample was not collected by a
person authorized to collect samples for required testing under this rule;
or
(c) The person submitting the
test sample requested that the analysis be performed for research and
development purposes.