New Mexico Register / Volume XXXIII, Issue 6 / March 22,
2022
This is an emergency amendment to
16.8.7 NMAC amending Section 8, effective 3/10/2022.
16.8.7.8 REQUIRED TESTING OF CANNABIS
PRODUCTS: A cannabis establishment
shall segregate a batch of cannabis product and arrange for samples to be
collected and tested by a cannabis testing laboratory if required by this
section. The batch must pass all required tests prior to the sale or delivery
to a qualified patient, primary caregiver or consumer.
A. Required testing: Unless an
exception applies:
(1) A
cannabis producer, cannabis producer microbusiness, vertically integrated
cannabis establishment, or integrated cannabis microbusiness shall arrange for
and pay for the testing specified in Table 1, Required Testing of Cannabis
Products, below, of any cannabis flower and trim that it harvests prior to:
(a) packaging
for retail sale;
(b) transfer
to another cannabis establishment for the purposes of retail sale;
(c) retail
sale; or
(d) delivery
to a patient or consumer.
(2) A
cannabis manufacturer, vertically integrated cannabis establishment, or
integrated cannabis microbusiness shall arrange for and pay for the testing
specified in Table 1 of any cannabis product, including but not limited to a
concentrate or extract, that it manufactures prior to:
(a) packaging
for retail sale
(b) transfer
to another cannabis establishment for the purposes or retail sale;
(c) retail
sale; or
(d) delivery
to a qualified patient, primary caregiver or consumer.
(3) A
cannabis retailer, vertically integrated cannabis establishment, or integrated
cannabis microbusiness shall not sell or deliver to a patient or consumer any
cannabis product unless the cannabis product has undergone all testing required
by this section.
(4) Testing
for homogeneity will be required beginning April 1, 2024.
Table 1, Required Testing of Cannabis Products |
||||||
Product category |
Potency |
Homogeneity
of Batch |
Visual
Inspection |
Microbiological |
Residual
Pesticides |
Residual Solvents |
Flower |
X |
X |
X |
X |
X |
|
Trim |
X |
X |
X |
X |
X |
|
Concentrate (volatile solvent) |
X |
|
|
X |
X |
X |
|
||||||
Kief |
X |
|
X |
X |
X |
|
Pre-rolls |
X |
|
|
X |
X |
|
Concentrate (non-volatile solvent) |
X |
|
X |
X |
X |
|
Extract – alcohol |
X |
|
|
X |
X |
|
Extract – other liquid |
X |
|
|
X |
X |
|
Topical |
X |
|
|
X |
|
|
Edible |
X |
|
|
X |
* |
|
Other inhalable |
X |
|
|
|
* |
X |
Other |
X |
|
|
X |
* |
X |
*Pesticide testing required
unless exempted by Subsection E, below.
B. Staggered implementation:
(1) The
division may within its discretion delay implementation of sample collection
and testing requirements of this section, in whole or in part.
(2) In
determining the start date of an individual testing requirement, the division
shall consider whether a cannabis testing laboratory has validated a method for
conducting the test.
(3) In determining the date on which a cannabis establishment
must have its samples collected by an employee or contractor of a cannabis
testing laboratory, the division shall consider the capacity of cannabis
testing laboratories to collect and transport samples.
(4) The division may establish different implementation dates
for sample collection requirements for:
(a) cannabis producer microbusinesses and integrated cannabis
microbusinesses located up to 100 miles by automobile from the nearest licensed
cannabis testing laboratory location;
(b) cannabis producers, cannabis manufacturers, and vertically
integrated cannabis establishments located up to 200 miles by automobile from
the nearest licensed cannabis testing laboratory location;
(c) cannabis producer microbusinesses and integrated cannabis
microbusinesses located more than 100 miles by automobile from the nearest
licensed cannabis testing laboratory location;
(d) cannabis
producers, cannabis manufacturers, and vertically integrated cannabis
establishments located more than 200 miles by automobile from the nearest
licensed cannabis testing laboratory location; and
(e) cannabis establishments for which travel to a licensed
cannabis testing laboratory location requires passing through a United States
border patrol checkpoint.
C. Collection and transportation of
samples: A
cannabis testing laboratory is responsible for the collection of samples for
the performance of any required test, re-test after a failing result, re-test
after remediation, or test for the purposes of labeling.
(1) A
cannabis testing laboratory may perform sample collection using:
(a) Laboratory
employees with requisite training, as specified in 16.8.2.26 NMAC; or
(b) Contractors
who have completed the sampling agent training offered by the U.S. department
of agriculture’s domestic hemp production program and sign an affidavit that
they have no ownership interest in, and are not employed by, any cannabis
establishment that produces or manufactures cannabis. The contractor shall
obtain necessary training to comply with the cannabis testing laboratory’s
protocols, and the cannabis testing laboratory may reject any sample that it
suspects was collected outside of its protocols.
(2) A
cannabis testing laboratory may transport samples using:
(a) Laboratory
employees with requisite training, as specified in 16.8.2.26 NMAC; or
(b) Contractors
who sign an affidavit that they have no ownership interest in, and are not
employed by, any cannabis establishment that produces or manufactures cannabis.
Transporting cannabis for a cannabis establishment on a contractual basis does
not preclude a person or entity from transporting samples in secure containers
for cannabis testing laboratories.
(3) Nothing
in these rules shall be interpreted to require a cannabis testing laboratory to
collect samples from or transport samples on behalf of any cannabis
establishment.
(4) If
the division has delayed implementation of the requirement that the cannabis
testing laboratory collect the sample from a cannabis establishment, based on
its distance from the nearest cannabis testing laboratory or location beyond a
U.S. border patrol checkpoint, then any person collecting or transporting
samples for required testing must receive training in sample collection and
transportation protocols.
(a) Nothing
in these rules shall be interpreted to require a cannabis testing laboratory to
accept samples from a cannabis establishment.
(b) The
cannabis testing laboratory may reject any sample that it suspects was
collected outside of its protocols.
(5) A
cannabis establishment may specify reasonable precautions prevent the
contamination of batches of cannabis, except that the cannabis establishment
must provide access to the entire batch of cannabis product. Precautions may
include, but are not limited to:
(a) requiring the use of gloves and
other personal protective equipment
(b) inspecting
tools and containers prior to their use;
(c) specifying
the location within the cannabis establishment at which the samples will be
collected;
(d) specifying
locations within the cannabis establishment to which laboratory employees or
contractors do not have access; and
(e) the
right to refuse entry to any laboratory employee or contractor not in
compliance with the precautions
(6) Nothing in these
rules shall be interpreted to require routine testing of cannabis products
before the cannabis establishment segregates cannabis products into batches and
places the batches into containers for storage while awaiting test results.
(7) This Subsection C of 16.8.7.8 NMAC is
effective March 1, 2023.
D. Compliance with all rules and applicable laws
required: Passage of testing does not relieve an establishment of
its obligation to comply with the Cannabis Regulation Act, the Lynn and Erin
Compassionate Use Act, the Pesticide Control Act, division rules, or other
local, state, and federal laws not in conflict with the Cannabis Regulation Act
or the Lynn and Erin Compassionate Use Act.
(1) A
cannabis establishment shall waste and dispose of any cannabis product to which
a pesticide has been applied in violation of division rules or the Pesticide
Control Act or any product manufactured using an unapproved solvent.
(2) Nothing
in this rule shall be interpreted as precluding regulatory activities by other
state agencies that do not conflict with the Cannabis Regulation Act or the
Lynn and Erin Compassionate Use Act.
E. Exceptions to required testing:
(1) A cannabis establishment shall not be
required to have tested for pesticide residue any cannabis product made from
cannabis concentrate or cannabis extract with verified pesticide residue test
results, so long as the establishment can demonstrate that the resulting
product will not exceed action levels for that type of cannabis product.
(2) A cannabis establishment shall not be
required to have tested a cannabis product acquired from another cannabis
establishment if the batch, in present form, was previously determined to have passed the testing requirements of this rule
and is accompanied by a Certificate of
Analysis issued by a licensed cannabis testing laboratory within the
previous 90 days.
(3) If
additional testing requirements take effect after a cannabis testing laboratory
obtains a sample of a cannabis product for required testing, the laboratory is
required to perform only those tests required at the time the sample was
obtained.
F. Visual inspection: A sample shall pass visual inspection if,
under a minimum of 40X magnification, laboratory personnel detect in a one gram
sample:
(1) no living or dead insects, hair,
eggs, or feces; and
(2) no more than two percent sand,
soil, mold, or rocks.
G. Microbiological
testing: A
sample shall pass microbiological testing if the sample contains concentrations
of target microbes not exceeding the action levels set forth in Table 2, Microbiological
Testing Requirements, below.
(1) The
division may require required testing for additional microbes if quality
control or inspection testing conducted by cannabis testing laboratories, NMDA,
the department of health, or the division identifies their presence, in a
quantity or amount that poses a threat to public health, in a cannabis product
produced, manufactured, or sold by any cannabis establishment. The division
shall provide written notice to licensees 30 days before requiring required
testing for additional pesticide residues, except that such notice is not
required when human illness is linked to contaminated cannabis products.
(2) The
cannabis testing laboratory may report a collective total of the four
Aspergillus strains listed without distinguishing individual totals.
(3) The
test results shall be reported as “Present,” “Absent,” or in colony forming
units (CFU) per one gram sample.
(4) Testing for shiga-toxin producing E.
coli, Clostridium botulinum, and Pseudomonas aeruginosa is effective July 1,
2022.
Table 2. Microbiological Testing
Requirements |
|
Target Microbe |
Action Level |
*E.
coli |
100
CFU/gram |
Aspergillus
flavus, Aspergillus fumigatus, Aspergillus niger, or Aspergillus terreus |
Present
in 1 gram |
Salmonella
spp. |
Present
in 1 gram |
†Shiga-toxin
producing E. coli |
Present
in 1 gram |
†Clostridium
botulinum |
Present
in 1 gram |
†Pseudomonas
aeruginosa |
Present
in 1 gram |
*Cannabis
product may be tested for shiga-toxin producing E. coli, rather than generic
E. coli. †Testing
for shiga-toxin producing E. coli, Clostridium botulinum, and Pseudomonas
aeruginosa is required only for edible cannabis products manufactured from
fresh cannabis with a water activity of 0.65 or greater. |
H. Residual solvent testing: A sample shall pass residual
solvent testing if the sample contains concentrations of residual solvents
lower than the action levels set forth in Table 3, Residual Solvent Testing
Requirements, below. The test results shall be reported as described in the
notes to Table 3.
Table 3. Residual Solvent Testing
Requirements |
|||||
Target Compounds |
Common Chemical Name |
IUPAC Name |
CAS Number |
Action Level* |
|
Propane |
Propane |
Propane |
74-98-6 |
5000 |
|
Butanes |
n-butane |
Butane |
106-97-8 |
5000 |
|
Isobutane |
2-methylpropane |
75-28-5 |
5000 |
|
|
Pentane |
n-pentane |
Pentane |
109-66-0 |
5000 |
|
Hexane |
n-hexane |
Hexane |
110-54-3 |
290 |
|
Benzene |
Benzene |
Benzene |
71-43-2 |
2.0 |
|
Toluene |
Toluene |
Methylbenzene |
108-88-3 |
890 |
|
Heptane |
n-heptane |
Heptane |
142-82-5 |
5000 |
|
Ethylbenzene and Xylenes |
Ethylbenzene |
Ethylbenzene |
100-41-4 |
2170
Total |
|
ortho-xylene |
1,2-dimethylbenzene |
95-47-6 |
|
||
meta-xylene |
1,3-dimethylbenzene |
108-38-3 |
|
||
para-xylene |
1,4-dimethylbenzene |
106-42-3 |
|
||
Ethanol† |
ethyl
alcohol |
Ethanol |
64-17-5 |
5000 |
|
Methanol |
methyl
alcohol |
Methanol |
67-56-1 |
3000 |
|
Isopropanol |
Isopropyl
alcohol |
2-propanol |
67-63-0 |
5000 |
|
Acetone |
Acetone |
2-propanone |
67-64-1 |
5000 |
|
Use
two significant digits when reporting residual solvent results. Report
levels less than the Limit of Quantitation for each solvent according to the
following example:: "Benzene < 2.0 µg/g" *Micrograms
solvent per gram (µg/g) of sample/parts per million (ppm). †Unless
exempt from testing. |
I. Potency and homogeneity testing:
(1) Potency
testing requires determining the quantity of tetrahydrocannabinol (THC),
tetrahydrocannabinolic acid (THCA), cannabidiol (CBD), cannabidiolic acid
(CBDA) per gram of sample and the calculation of THC potency and CBD potency,
according to Table 4, Potency Testing Requirements, below.
(2) Batch-level
homogeneity testing is performed by testing for total THC potency. The number
of samples to be tested shall be based on the size of the batch according to
the method validated by the cannabis testing laboratory; however, the total
number of samples tested shall be not less than three for any batch of material
five pounds or less.
(3) Product-level
homogeneity testing is performed by segregating a single retail package or an
identical quantity of a solid or semi-solid and testing for total THC potency a
minimum of three randomly selected increments of the product.
(4) A
set of samples shall pass homogeneity testing if the relative standard
deviation of total THC potency of the samples is no more than twenty percent.
Table 4. Potency Testing Requirements |
|||
Cannabinoid |
Abbreviation |
CAS Number |
Reporting Units |
Tetrahydrocannabinolic Acid |
THCA |
23978-85-0 |
For solids: mg of analyte/gram of sample
and percentage by weight For liquids: mg/ml |
Tetrahydrocannabinol |
THC |
1972-08-3 |
|
Cannabidiolic Acid |
CBDA |
1244-58-2 |
|
Cannabidiol |
CBD |
13956-29-1 |
|
Total THC Potency (solids) |
THC Potency =
(Percent THCA × 0.877) + Percent THC |
Percentage by
weight |
|
Total CBD Potency (solids) |
CBD Potency =
(Percent CBDA × 0.877) + Percent CBD |
||
Total THC Potency (liquids) |
THC Potency =
(mg/ml THCA × 0.877) + mg/ml THC |
mg/ml |
|
Total CBD Potency (liquids) |
CBD Potency =
(mg/ml CBDA × 0.877) + mg/ml CBD |
J. Pesticide
testing: A sample shall pass pesticide testing if concentrations
of residues of pesticides are lower than the action levels listed in Table 5, Pesticide
Testing Requirements, below.
(1) The
division may adopt required testing for additional pesticide residues if quality
control or inspection testing conducted by cannabis testing laboratories, NMDA,
the Department of Health, or the division identifies their presence in a
cannabis product produced or manufactured by any cannabis establishment. The
division shall provide written notice to licensees 30 days before implementing
required testing for additional pesticide residues.
(2) Nothing
in this section shall be interpreted to waive or diminish any requirement of
the Pesticide Control Act, §§76-4-1 et seq. NMSA 1978. The division, alone or in conjunction with NMDA, may investigate any
suspected use of a pesticide not registered with NMDA for use on cannabis.
(3) This Subsection J of 16.8.7.8 NMAC is
effective July 1, 2022.
Table 5. Pesticide Testing
Requirements |
|||
Targeted Pesticide |
CAS Number |
Action Level: Inhalable* |
Action Level: Non-Inhalable* |
†Abamectin |
71751-41-2 |
0.1 |
0.15 |
†Acequinocyl |
57960-19-7 |
2.0 |
2.0 |
†Bifenazate |
149877-41-8 |
0.2 |
0.2 |
†Bifenthrin |
82657-04-3 |
0.1 |
0.1 |
†Etoxazole |
153233-91-1 |
0.1 |
1.0 |
†Imazalil |
35554-44-0 |
0.1 |
0.1 |
†Imidacloprid |
138261-41-3 |
0.1 |
3.0 |
†Myclobutanil |
88671-89-0 |
0.1 |
0.4 |
†Paclobutrazol |
76738-62-0 |
0.04 |
0.04 |
Piperonyl butoxide |
51-03-6 |
3.0 |
8.0 |
†Pyrethrins (cumulative total) |
121-21-1 25402-06-6
4466-14-2 |
0.5 |
1.0 |
†Spinosyn A, D (cumulative total) |
131929-60-7 131929-63-0 |
0.1 |
3.0 |
†Spiromesifen |
283594-90-1 |
0.1 |
0.2 |
†Spirotetramat |
203313-25-1 |
0.1 |
0.2 |
†Trifloxystrobin |
141517-21-7 |
0.02 |
0.02 |
Other pesticide not registered with
NMDA for use on cannabis |
Varies |
0.02 |
0.02 |
*Micrograms
of pesticide per gram (µg/g) of
sample/parts per million (ppm). Report
levels less than the Limit of Quantitation for each pesticide residue
according to the following example: "Paclobitrazol < 0.4 µg/g" †Not
registered with NMDA for use on cannabis. |
K. Release of batch after testing: A cannabis establishment may
release an entire batch of cannabis product for immediate manufacture, sale, or other use, provided that the sample
taken from the batch passes the tests required in this section.
L. Procedures
for testing: A cannabis establishment shall adhere to the following
procedures:
(1) After
collection of samples, a batch of cannabis product shall be segregated in a secure
container and stored under controlled environmental conditions (temperature,
humidity, light) designed to limit microbial growth or other spoilage until the
cannabis establishment receives a certificate of analysis indicating the batch
meets the testing requirements of this rule.
(2) The
secured container shall be labeled with the identification number used in the
track and trace system, the name of the cannabis testing laboratory, the date
on which the samples were taken, and, in minimum 12-point font, all capital
letters, “AWAITING TEST RESULTS. DO NOT TRANSER.”
(3) The
cannabis testing laboratory and the cannabis establishment submitting samples
each shall appropriately document in the track and trace system the sampling
and testing of cannabis product.
(4) A
cannabis establishment shall maintain all results of laboratory tests conducted
on cannabis products produced or manufactured by the cannabis establishment for
a period of at least two years and shall make those results available to consumers
or cannabis retailers upon request.
M. Re-testing: If a sample fails any test, the cannabis establishment may
request re-testing by the same cannabis testing laboratory or another cannabis
testing laboratory. If the repeated test is within acceptable limits, then the
batch may be sold, transferred, or further manufactured.
N. Remediation:
Within 120 days of a failed test, a cannabis establishment may remediate
and retest the batch according to the procedures described in this subsection.
A cannabis establishment shall adopt and maintain on the premises protocols
regarding remediation consistent with this rule.
(1) A
cannabis establishment may remediate dried cannabis or cannabis concentrates
that fail microbiological testing by means of extraction using an approved
volatile solvent. Other products that fail microbiological testing may not be
remediated.
(2) A
cannabis establishment may remediate any cannabis product that fails
homogeneity testing through any approved manufacturing process, including
extraction, chopping, melting, mixing, infusing, or otherwise combining the
batch.
(3) A
cannabis establishment may remediate any cannabis product that fails residual
solvent testing by evaporating solvent using heat, vacuum pressure, or a combination
of methods.
(4) A
cannabis establishment may remediate cannabis that fails visual inspection for
the presence of mold by means of extraction using an approved volatile solvent.
(5) A
cannabis establishment may remediate cannabis that fails visual inspection for
the presence of insects, hair, eggs, or feces by removing the contaminants,
followed by extraction using an approved volatile solvent.
(6) A
cannabis establishment may remediate cannabis that fails visual inspection for
the presence of soil or rocks by removing the contaminants.
(7) Cannabis
product that has been remediated must undergo any test that was previously
failed.
(8) Cannabis
product that has been remediated with the use of volatile solvents must
additionally undergo residual solvent testing.
O. Notice
and destruction: Any cannabis
product that fails a test and cannot be remediated, including any
remediated cannabis product that fails any test after remediation, is subject
to destruction in accordance with the wastage requirements of 16.8.2.15 NMAC.
The cannabis establishment shall notify the division within 24 hours and shall
confirm the wastage and disposal of the usable cannabis in accordance with this
rule. The wasted product shall be removed from inventory, and the removal from
inventory shall be noted in the track and trace system.
P. Interpretation of differing results:
Results produced by a cannabis testing laboratory are valid only for the sample
tested. A differing result produced by quality control or inspection testing of
a different sample pursuant to 16.8.2.16 NMAC is not grounds for action against
the cannabis testing laboratory that produced the original testing result.
[16.8.7.8 NMAC – N, 3/1/2022; A/E,
03/10/2022]