New Mexico Register / Volume XXXIII, Issue 13 / July 12, 2022
This is an amendment to 16.8.7 NMAC amending Sections
8, 9, and 10 and adding Sections 11, 12, 13, 14, 15, 16, 17, and 18 effective
07/12/2022.
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.
|
||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
*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.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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.
|
|||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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.
|
|||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||
|
|
|
|
|
|
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.
|
|||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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.]
GENERAL TRACKING
REQUIREMENTS: In
addition to any requirements specific to tracking within each license type, all
licensees of cannabis establishments must meet minimum requirements.
A. Tracking immature cannabis
plants: licensees must track, using the track and trace system specified by
the division, cannabis plants as follows:
(1) each immature plant shall be assigned
a plant tag with an individual track and trace number and shall be:
(a) placed contiguous to one another
to facilitate identification by the division; and
(b) be fully separated from mature
plants.
(2) Immature plants transferred from one
licensee to another shall be labeled with the track and trace number that
corresponds to the track and trace number. The receiving licensee shall remove
the originating licensee’s tag and assign a plant or package tag, as
applicable, belonging to the receiving licensee within three calendar days of
receiving the immature plants.
B. Tracking
mature cannabis plants: mature cannabis plants shall be tagged as follows:
(1) Each mature plant shall be tagged
with a plant tag. A plant tag shall be attached to the main stem at the base of
the plant, placed in a position so it is visible and within clear view of an
individual standing next to the mature plant, and kept free from dirt and
debris.
(2) Licensees are prohibited from
removing the plant tag from the mature plant to which it was attached and
assigned until the plant is harvested, destroyed, or disposed of.
C. Tracking cannabis and cannabis products: licensees must track, using the track and trace system
specified by the division, cannabis and cannabis
products according to packaging and labeling requirements set forth in 16.8.3
NMAC.
D. Additional
recorded information: in addition to any tracking requirements specific to
license type or cannabis product type, a licensee must ensure the following
data is properly recorded in the tracking system:
(1) a complete inventory of all cannabis
and cannabis products in the possession, control or ownership of the licensee;
(2) any changes to the licensee’s
inventory of any cannabis or cannabis products;
(3) when cannabis material is converted
to waste
(4) when cannabis waste is destroyed;
(5) when an authorized transfer of cannabis
or cannabis product occurs;
(6) any theft of cannabis or cannabis products;
(7) all sales records of cannabis or
cannabis product;
(8) all mandatory cannabis or cannabis
product testing results;
(9) the county and municipality, if
applicable, where the cannabis or cannabis product was harvested, otherwise
cultivated, manufactured, tested, sold to other licensees, sold to consumers and disposed of or destroyed; and
(10) other information required by the
tracking system or specified by the division.
(11) cannabis
material in segregation while testing occurs.
[16.8.7.8 NMAC – N,
3/1/2022; A/E, 03/10/2022; Rp,
16.8.7.8 NMAC, 07/12/2022]
16.8.7.9 [ADDITIONAL
TESTING SERVICES OFFERED BY CANNABIS TESTING LABORATORIES:
A cannabis testing laboratory may offer cannabis
establishments testing for quality improvement, research and development, or
labeling purposes. A cannabis testing laboratory may also offer testing to
persons other than cannabis establishments as provided in this section.
A. Research and
development testing for cannabis establishments: A cannabis
testing laboratory may offer to cannabis establishments any required test or
any additional test for the purpose of research and development or for
quality-control measures requested by a cannabis establishment.
(1) The
cannabis establishment may collect the sample, or an agent of the cannabis
testing laboratory may collect the sample.
(2) If
a cannabis establishment requests testing for research and development
purposes, the results may not be used to satisfy any required testing
requirement, even if the sample passes all tests.
(3) The
failure of a test for research and development purposes shall not constitute a
failed test.
(4) The
results of a test conducted for research and development purposes shall not be
included on a product label or advertisement.
B. Testing for the purposes of labeling by
cannabis establishments: A cannabis testing laboratory may offer to
cannabis establishments additional tests not included in required testing for
the purposes of product labeling, including quantitation of specific
pesticides, microbial contaminants, solvents, mycotoxins, or metals.
(1) An
agent of the cannabis testing laboratory shall collect the samples according to
the laboratory’s protocols.
(2) A
label may include a reference to concentrations of compounds not subject to required
testing, including terpenes, terpenoids, or additional cannabinoids.
(3) A
label may include a reference to the passage of cannabis screenings, including
one or more of the following:
(a) naming
the contaminants for which screening was performed;
(b) providing
a link or QR code to the list of contaminants for which the cannabis product
was screened; or
(c) a
statement that the product has met third-party screening criteria, such as
those established by an industry association, except that no label shall
contain claims that a cannabis product is “pesticide free” or “organic” unless
such labeling is specifically authorized under U.S. department of agriculture
regulations.
C. Reporting of contamination: Nothing
in this rule shall be interpreted to require a cannabis testing laboratory to
offer testing for analytes not included in required testing. However, a
cannabis testing facility shall report to the division, without naming the
source of the sample, the detection of any of the following analytes in the course of testing for research and development or
labeling purposes:
(1) aflatoxin
B1, B2, G1, and G2 and ochratoxin A, at a total concentration of 20 µg/kg
(parts per billion) or greater;
(2) arsenic,
cadmium, lead, or mercury, at a concentration of 0.4 µg/g (parts per million)
or greater;
(3) the
residue of any pesticide not required to be tested or not registered in New
Mexico for use on cannabis, at any level detectable by the cannabis testing
laboratory’s methodology; or
(4) any
microorganism not required to be tested at a level that poses a significant
threat to human health.
D. Research and development testing in
connection with personal use or medical use of Cannabis. A cannabis
testing laboratory may perform any test on a sample of cannabis product for any
resident of New Mexico who is at least 21 years of age and represents in
writing that the cannabis product is for the personal use or medical use of the
person submitting the sample or a person for whom the person submitting the
sample is acting as a primary caregiver. The cannabis testing laboratory shall
provide guidance on sample collection but shall not collect samples onsite.
E. Testing services to entities operated or
licensed by a tribal government. A cannabis testing laboratory may
perform any test on a sample of cannabis product for any entity located within
New Mexico and operated or licensed by a tribal government with which the
division has an intergovernmental agreement covering cannabis testing. If the
intergovernmental agreement permits such entities to collect and submit
samples, the cannabis testing laboratory shall provide guidance on sample
collection. Otherwise, an agent of the laboratory shall collect samples.
F. Testing services for the division or other
governmental entities: A cannabis testing laboratory may, but is not
required to, perform any test on behalf of the division, NMDA, another state
agency, or a state or local law enforcement authority acting within its lawful
jurisdiction.]
IMPLEMENTATION AND
ADMINISTRATION OF TRACKING SYSTEM:
A. Operational account: a
licensee must have a track and trace system account activated and functional
prior to operating or exercising any privileges of a license. The licensee
shall keep and maintain comprehensive records to ensure adequate inventory
tracking of any cannabis or cannabis products.
B. System administrator required: each
licensee must designate at least one individual as a track and trace system
administrator.
C. System training: in order to obtain a track and trace system administrator
account, a licensee or its designee must attend and successfully complete all
required track and trace system training. A licensee may apply for an account
and training once they receive a license from the division.
D. Continuing education: The
division may also require additional ongoing, continuing education for the
track and trace system administrator to retain their track and trace system
administrator account.
E. Responsible for cost: each
licensee is responsible for all costs associated with its use of the tracking
system and any associated vendor fees.
F. Additional users: a licensee
may designate additional individuals as track and trace system users. The licensee
shall ensure that all individuals who are granted track and trace system user
account access for the purposes of conducting track and trace functions in the
system are trained by an track and trace system
administrator in the proper and lawful use of the track and trace system.
[16.8.7.9 NMAC – N, 3/1/2022; Rp, 16.8.7.9 NMAC, 07/12/2022]
16.8.7.10 [PREVENTION OF HEAVY METAL CONTAMINATION: A cannabis establishment shall
adhere to the following quality control standards for the production and
manufacturing of cannabis:
A. Growing
media: The cannabis establishment
shall maintain, and make available for division inspection, records of all
growing media purchased.
B. Water: If using for irrigation water from a
non-municipal source, a cannabis establishment shall maintain quarterly testing
data indicating concentrations at or below the action levels in Table 1, Heavy
Metal Testing Requirements for Water and Soil, below.
C. Soil: If growing cannabis directly in the ground,
the cannabis establishment shall submit at least annually representative soil
samples to a laboratory for analysis of arsenic, cadmium, lead, and mercury
levels and shall retain a certificate of analysis for inspection by the
division. If the concentration of any heavy metal exceeds the action levels in
Table 1, Heavy Metal Testing Requirements for Water and Soil, below, the
cannabis establishment shall remediate the soil and shall not produce
additional plants until soil concentrations are below the applicable action
levels.
D. Choice
of laboratories: The cannabis
establishment may submit water or soil samples to any laboratory in the United
States offering water or soil analysis for the four required analytes.
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GENERAL TRACK AND
TRACE SYSTEM USE:
A. System required: all track
and trace activities of a licensee must be tracked through use of the track and
trace system. Licensees must reconcile all on-premises and in-transit cannabis
or cannabis products each day in the track and trace system by 11:59 p.m. that
same day. Track and trace system software must then be synchronized by the
licensee prior to closing the session (as applicable).
B. Weights and measures: licensees
must utilize a standard of weights and measures that is supported by the track
and trace system to track all cannabis or cannabis products. A scale used to
weigh product prior to entry into the track and trace system shall be certified
to be registered and calibrated in accordance with applicable requirements of
the New Mexico department of agriculture
C. System security: licensees
shall maintain the security of the track and trace system, as follows:
(1) maintain an accurate and complete
list of all track and trace system users for each licensed premise;
(2) update this list when a new track and
trace system user is trained or when an existing user is removed;
(3) train and authorize any new track and
trace system users before they may access track and trace system or input,
modify or delete any information in the track and trace system; and
(4) cancel any track and trace system
administrators and track and trace system users from their associated track and
trace system accounts once any such individuals are no longer employed by the
licensee or at the licensed premises.
D. Responsible for employee actions:
licensees are accountable for all actions employees take while logged into
the track and trace system or otherwise conducting cannabis or cannabis product
inventory tracking activities.
E. Responsible for individual
actions: each individual user is also accountable for all of their actions
while logged into the track and trace system or otherwise conducting cannabis
or cannabis product inventory tracking activities, and
shall maintain compliance with all relevant laws and division rules.
F. Use of appropriate account: each
individual user shall only log activities in the track and trace system under
the user’s own unique track and trace system user account.
G. Additional
software allowed: licensees may use separate software applications to
collect information to be used by the business, including additional inventory
tracking or point of sale systems.
[16.8.7.10 NMAC – N, 3/1/2022; Rp, 16.8.7.10 NMAC, 07/12/2022]
16.8.7.11 CONDUCT
WHILE USING TRACK AND TRACE SYSTEM:
A. Licensees or designated track and
trace administrator(s) and track and trace system user(s) shall enter data into
the track and trace system that fully and transparently accounts for all
inventory tracking activities and authorized transfers. Both the licensee and
the individuals using the track and trace system are responsible for the
accuracy of all information entered into the track and trace system.
B. Individuals entering data into the
track and trace system shall only use that individual’s track and trace system
account.
C. If at any point a licensee loses
access to the track and trace system for any reason, the licensee or track and
trace system administrator shall immediately notify the division and shall keep
and maintain comprehensive records detailing all cannabis or cannabis product
track and trace activities that occurred during the loss of access. These track
and trace activities must be entered into the track and trace system and the
division shall be notified that access has been restored. Licensees must
document when access to the system was lost, the cause of system loss and when
it was restored. Licensee shall not transport or receive any cannabis or
cannabis product to or from another cannabis establishment until such time as
access is restored and all information is recorded into the track and trace
system.
[16.8.7.11 NMAC – Rp,16.8.7.11 NMAC, 07/12/2022]
16.8.7.12 COMPLIANCE NOTIFICATIONS:
A. Monitor notifications: licensees
must monitor all compliance notifications from the track and trace system or
the division and must resolve any issue(s) detailed in the compliance
notification in a timely fashion. Compliance notifications from the track and
trace system shall not be dismissed in the track and trace system until the
licensee resolves the compliance issues detailed in the notification.
B. Monitor informational
notifications: licensees must take appropriate action in response to
informational notifications received through the track and trace system or the
division including but not limited to notifications related to enforcement
alerts and other pertinent information.
[16.8.7.12 NMAC - N, 07/12/2022]
16.8.7.13 LAWFUL ACTIVITY REQUIRED: Proper use of the
track and trace system does not relieve a licensee of its responsibility to
maintain compliance with all laws, rules and other
requirements at all times.
[16.8.7.13 NMAC - N, 07/12/2022]
16.8.7.14 TRACK AND TRACE SYSTEM PROCEDURES:
A. Conformity of use: licensees must utilize
the track and trace system in conformance with division rule and track and
trace system procedures.
B. Track
and trace procedures include:
(1) properly indicating the creation of a
harvest batch or production batch including the assigned harvest batch or
production batch number;
(2) accurately identifying the
cultivation room or outdoor location where each plant is located on the
licensed premises;
(3) accurately identifying when inventory
is no longer on the licensed premises;
(4) properly
identifying cannabis or cannabis products identified as test batch;
(5) properly
indicating test results from a cannabis testing laboratory;
(6) accurately indicating the track and
trace system category for all cannabis or cannabis products;
(7) accurately including a note
explaining the reason for any destruction of cannabis or cannabis products, and
the reason for any adjustment in weight or count to inventory in the track and
trace system software; and
(8) properly assigning unique identifying
tracking numbers to each cannabis plant, cannabis product and any batch, lot,
or sublot from such cannabis plant(s) and cannabis product(s).
[16.8.7.14 NMAC - N, 07/12/2022]
16.8.7.15 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.
[16.8.7.15 NMAC – N, 07/12/2022]
16.8.7.16 ADDITIONAL
TESTING SERVICES OFFERED BY CANNABIS TESTING LABORATORIES:
A cannabis testing laboratory may offer cannabis establishments
testing for quality improvement, research and development, or labeling
purposes. A cannabis testing laboratory may also offer testing to persons other
than cannabis establishments as provided in this section.
A. Research and
development testing for cannabis establishments: A cannabis
testing laboratory may offer to cannabis establishments any required test or
any additional test for the purpose of research and development or for
quality-control measures requested by a cannabis establishment.
(1) The
cannabis establishment may collect the sample, or an agent of the cannabis
testing laboratory may collect the sample.
(2) If
a cannabis establishment requests testing for research and development
purposes, the results may not be used to satisfy any required testing
requirement, even if the sample passes all tests.
(3) The
failure of a test for research and development purposes shall not constitute a
failed test.
(4) The
results of a test conducted for research and development purposes shall not be
included on a product label or advertisement.
B. Testing for the purposes of labeling by
cannabis establishments: A cannabis testing laboratory may offer to
cannabis establishments additional tests not included in required testing for
the purposes of product labeling, including quantitation of specific
pesticides, microbial contaminants, solvents, mycotoxins, or metals.
(1) An
agent of the cannabis testing laboratory shall collect the samples according to
the laboratory’s protocols.
(2) A
label may include a reference to concentrations of compounds not subject to
required testing, including terpenes, terpenoids, or additional cannabinoids.
(3) A
label may include a reference to the passage of cannabis screenings, including
one or more of the following:
(a) naming
the contaminants for which screening was performed;
(b) providing
a link or QR code to the list of contaminants for which the cannabis product
was screened; or
(c) a
statement that the product has met third-party screening criteria, such as
those established by an industry association, except that no label shall
contain claims that a cannabis product is “pesticide free” or “organic” unless
such labeling is specifically authorized under U.S. department of agriculture
regulations.
C. Reporting of contamination: Nothing
in this rule shall be interpreted to require a cannabis testing laboratory to
offer testing for analytes not included in required testing. However, a
cannabis testing facility shall report to the division, without naming the
source of the sample, the detection of any of the following analytes in the course of testing for research and development or
labeling purposes:
(1) aflatoxin
B1, B2, G1, and G2 and ochratoxin A, at a total concentration of 20 µg/kg
(parts per billion) or greater;
(2) arsenic,
cadmium, lead, or mercury, at a concentration of 0.4 µg/g (parts per million)
or greater;
(3) the
residue of any pesticide not required to be tested or not registered in New
Mexico for use on cannabis, at any level detectable by the cannabis testing
laboratory’s methodology; or
(4) any
microorganism not required to be tested at a level that poses a significant
threat to human health.
D. Research and development testing in
connection with personal use or medical use of Cannabis. A cannabis
testing laboratory may perform any test on a sample of cannabis product for any
resident of New Mexico who is at least 21 years of age and represents in
writing that the cannabis product is for the personal use or medical use of the
person submitting the sample or a person for whom the person submitting the
sample is acting as a primary caregiver. The cannabis testing laboratory shall
provide guidance on sample collection but shall not collect samples onsite.
E. Testing services to entities operated or
licensed by a tribal government. A cannabis testing laboratory may
perform any test on a sample of cannabis product for any entity located within
New Mexico and operated or licensed by a tribal government with which the
division has an intergovernmental agreement covering cannabis testing. If the
intergovernmental agreement permits such entities to collect and submit
samples, the cannabis testing laboratory shall provide guidance on sample
collection. Otherwise, an agent of the laboratory shall collect samples.
F. Testing services for the division or other
governmental entities: A cannabis testing laboratory may, but is not
required to, perform any test on behalf of the division, NMDA, another state
agency, or a state or local law enforcement authority acting within its lawful
jurisdiction.
[16.8.7.16 NMAC – N, 07/12/2022]
16.8.7.17 PREVENTION OF HEAVY METAL CONTAMINATION: A cannabis establishment shall
adhere to the following quality control standards for the production and
manufacturing of cannabis:
A. Growing
media: The cannabis establishment shall
maintain, and make available for division inspection, records of all growing
media purchased.
B. Water: If using for irrigation water from a
non-municipal source, a cannabis establishment shall maintain quarterly testing
data indicating concentrations at or below the action levels in Table 1, Heavy
Metal Testing Requirements for Water and Soil, below.
C. Soil: If growing cannabis directly in the ground,
the cannabis establishment shall submit at least annually representative soil
samples to a laboratory for analysis of arsenic, cadmium, lead, and mercury
levels and shall retain a certificate of analysis for inspection by the
division. If the concentration of any heavy metal exceeds the action levels in
Table 1, Heavy Metal Testing Requirements for Water and Soil, below, the
cannabis establishment shall remediate the soil and shall not produce
additional plants until soil concentrations are below the applicable action
levels.
D. Choice
of laboratories: The cannabis
establishment may submit water or soil samples to any laboratory in the United
States offering water or soil analysis for the four required analytes.
Table 1. Heavy Metal Testing Requirements for Water and Soil |
||||
Analyte |
Symbol |
CAS Number |
Action Level: Soil* |
Action Level: Water† |
Arsenic |
As |
7440-38-2 |
4.25 |
10.0 |
Cadmium |
Cd |
7440-43-9 |
7.05 |
5.0 |
Lead |
Pb |
7439-92-1 |
400 |
15.0 |
Mercury |
Hg |
7439-97-6 |
2.38 |
2.0 |
*Reported in micrograms per gram (µg/g)
of sample/parts per million (ppm). Based on New Mexico Environment
Department’s Risk Assessment Guidance for Site Investigations and
Remediation. †Reported in micrograms per liter (µg/L)
of sample. Based on U.S. Environmental Protection Agency’s maximum
contaminant levels. |
[16.8.7.17 NMAC – N, 07/12/2022]
[16.8.7.11] 16.8.7.18 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.
[16.8.7.18 NMAC – N, 3/1/2022; Rn, 16.8.7.11 NMAC,
07/12/2022]