New Mexico Administrative Code › Title 7 - HEALTH › Chapter 34 - MEDICAL USE OF CANNABIS › Part 4 - LICENSING REQUIREMENTS FOR PRODUCERS, PRODUCTION FACILITIES AND DISTRIBUTION › Section 7.34.4.10 - TESTING OF USABLE CANNABIS

Current through Register Vol. 35, No. 13, July 16, 2024
All dried usable cannabis produced by a non-profit producer
				  that is not converted into a concentrated cannabis derived product, and all
				  concentrated cannabis derived products manufactured by a non-profit producer or
				  manufacturer, shall be sampled for testing purposes by the licensed non-profit
				  producer or manufacturer, and those samples shall be tested by an approved
				  laboratory consistent with the requirements of this rule and found to have
				  passed all tests required by this rule, prior to the sale, distribution, or
				  other use of the product. Each batch of dried usable cannabis, other than
				  cannabis that will be converted into a concentrated cannabis derived product,
				  shall be segregated and sampled by the non-profit producer that produced the
				  batch, and the non-profit producer shall ensure that each sample is tested by
				  an approved laboratory in accordance with the testing requirements of this rule
				  and determined to have passed the following individual testing requirements,
				  before dried usable cannabis from that batch is made available for sale or
				  distribution, and before the dried usable cannabis or any substance derived
				  therefrom is incorporated into a cannabis derived product. Each batch of
				  concentrated cannabis derived product shall be segregated and sampled by the
				  manufacturer or non-profit producer that produced the batch, and the
				  manufacturer or non-profit producer (as applicable) shall ensure that each
				  sample is tested by an approved laboratory in accordance with the testing
				  requirements of this rule, and determined by the manufacturer or non-profit
				  producer (as applicable) to have passed the following individual testing
				  requirements, before cannabis derived product from that batch is made available
				  for sale or distribution.
A.
Exception; staggered implementation
: The department may within its
				discretion waive testing requirements of this section, in whole or in part,
				based on considerations such as the ability of currently approved laboratories
				to process all testing samples, or in order to allow additional time for
				laboratories to implement revised testing standards.
B.
Exception for previously tested
				cannabis:
Except as otherwise provided in this rule, a non-profit
				producer or manufacturer shall not be required to sample and test dried usable
				cannabis or a concentrated cannabis-derived product if the batch was previously
				sampled and the sample was tested by another non-profit producer or
				manufacturer in accordance with this rule and determined to have passed the
				testing requirements of this rule.
C.
Individual testing requirements:
(1)
Microbiological test:
A non-profit producer shall sample and test dried usable cannabis, and a
				manufacturer or non-profit producer (as applicable) shall sample and test
				concentrated cannabis derived products, for microbiological contaminants, using
				an approved laboratory prior to sale, distribution, or other use. A sample may
				be deemed to have passed the microbiological test if the sample contains less
				than each action level set forth in Table 1, Microbiological Testing
				Requirements, below.
Table 1. Microbiological Testing
								Requirements
Final Product
Test Parameter
Action Level
Test Units
Chopped or Powdered Botanicals (Dried Usable
								Cannabis Not Extracted)
Total Aerobic Microbial Count
>100000
cfu/g or cfu/mL
Total Combined Yeast & Mold Count
>1000
cfu/g or cfu/mL
Bile-tolerant Gram-negative Bacteria
>1000
cfu/g or cfu/mL
Absence of Salmonella spp. & E. coli
Absent
In 10 grams cfu/g or cfu/mL
Total Coliforms Count
>1000
cfu/g or cfu/mL
Powdered Botanical Extracts (Extracted or
								Processed Cannabis Product i.e. hash, bubble hash, rosin, kief)
Total Aerobic Microbial Count
>10000
cfu/g or cfu/mL
Total Combined Yeast & Mold Count
>1000
cfu/g or cfu/mL
Bile-tolerant Gram-negative Bacteria
>1000
cfu/g or cfu/mL
Absence of Salmonella spp. & E. coli
Absent
In 10 grams cfu/g or cfu/mL
Total Coliforms Count
>1000
cfu/g or cfu/mL
Tinctures (Solutions of Cannabis in
								Alcohol)
Total Aerobic Microbial Count
>10000
cfu/g or cfu/mL
Total Combined Yeast & Mold Count
>1000
cfu/g or cfu/mL
Infusions (solutions of cannabis in
								water)
Total Aerobic Microbial Count
>100
cfu/g or cfu/mL
Total Combined Yeast & Mold Count
>10
cfu/g or cfu/mL
Decoctions (Solutions of Cannabis derived by
								boiling in water for at least 15 minutes)
Total Aerobic Microbial Count
>100
cfu/g or cfu/mL
Total Combined Yeast & Mold Count
>10
cfu/g or cfu/mL
Fluid extracts (An alcoholic liquid extract
								made by percolation of Cannabis so that 1 mL of the fluidextract represents 1 g
								of the Cannabis)
Total Aerobic Microbial Count
>10000
cfu/g or cfu/mL
Total Combined Yeast & Mold Count
>1000
cfu/g or cfu/mL
Nutritional Supplements with
								Botanicals
Total Aerobic Microbial Count
>100000
cfu/g or cfu/mL
Total Combined Yeast & Mold Count
>1000
cfu/g or cfu/mL
Absence of Salmonella spp. & E. coli
Absent
In 10 grams cfu/g or cfu/mL
Botanicals to be treated with boiling water
								before use (Dried Cannabis to which boiling water is added immediately prior to
								consumption)
Total Aerobic Microbial Count
>100000
cfu/g or cfu/mL
Total Combined Yeast & Mold Count
>1000
cfu/g or cfu/mL
Absence of E. coli
Absent
In 10 grams cfu/g or cfu/mL
Nutritional products with other highly
								refined ingredients (Edibles)
Total Aerobic Microbial Count
>1000
cfu/g or cfu/mL
Total Combined Yeast & Mold Count
>100
cfu/g or cfu/mL
Absence of E. coli
Absent
In 10 grams cfu/g or cfu/mL
Quantitative analysis results shall be rounded off
								to the first two significant digits.
E. coli and Salmonella results shall be reported as
								Present or Absent.
(2)
Mycotoxin test:
A non-profit producer shall sample and test dried
				usable cannabis, and a manufacturer or non-profit producer (as applicable)
				shall sample and test concentrated cannabis derived products, for mycotoxins,
				using an approved laboratory prior to sale, distribution, or other use. A
				sample may be deemed to have passed the mycotoxin test if the total quantity of
				aflatoxin B1, B2, G1, and G2 and ochratoxin A is collectively less than 20
				µg/kg (parts per billion) of the sample. The mycotoxin test shall be
				conducted in accordance with the testing requirements at Table 2, Mycotoxins
				Testing Requirements.
Table 2. Mycotoxins Testing
								Requirements
Targeted Mycotoxins
Chemical Name
Abbreviation
CAS Number
Method Reporting Level
								(µg/kg)*
Action Level (µg/kg)*
Aflatoxins
Aflatoxin B1
AFB1
1162-65-8
1.0
Combined concentration of five mycotoxin
components:
20
Aflatoxin B2
AFB2
7220-81-7
1.0
Aflatoxin G1
AFG1
1165-39-5
1.0
Aflatoxin G2
AFG2
7241-98-7
1.0
Ochratoxin
Ochratoxin A
OTA
303-47-9
1.0
Mycotoxins Reporting Requirements for DOH
								Medical Cannabis Program
Use two significant digits when reporting a
								total mycotoxins result.
Non-detects are reported as less than the Method
								Reporting Level. Example: "Total Mycotoxins < 1 µg/kg"
*Micrograms of mycotoxin per kilogram (µg/kg)
								of sample is equivalent to parts per billion (ppb).
(3)
Residual solvent test:
A manufacturer or non-profit producer (as
				applicable) shall sample and test all concentrated cannabis derived products
				that are manufactured using solvent extraction methods for the presence of
				solvent residue, using an approved laboratory prior to sale, distribution, or
				other use. A sample may be deemed to have passed the residual solvent test if
				the sample contains less than each action level set forth in Table 3, Residual
				Solvent Testing Requirements. The residual solvent test shall be conducted in
				accordance with the testing requirements at Table 3.
Table 3. Residual Solvent Testing
								Requirements
Targeted Compounds
Common Chemical Name
IUPAC Name
CAS Number
Method Reporting Level (µg/g) or
								(ppm)*
Action Level (µg/g) or
								(ppm)*
Propane
propane
propane
74-98-6
100
500
Butanes
n
-butane
butane
106-97-8
100
500
isobutane
2-methylpropane
75-28-5
100
500
Pentane
n
-pentane
pentane
109-66-0
100
500
Hexane
n
-hexane
hexane
110-54-3
25
50
Cyclohexane
cyclohexane
cyclohexane
110-82-7
100
500
Benzene
benzene
benzene
71-43-2
2.0
2.0
Toluene
toluene
methylbenzene
108-88-3
100
200
Heptane
n
-heptane
heptane
142-82-5
100
500
Ethylbenzene
ethylbenzene
ethylbenzene
100-41-4
100
Combined
concentration of
all four
compounds:
400
and Xylenes
ortho
-xylene
1,2-dimethylbenzene
95-47-6
100
meta
-xylene
1,3-dimethylbenzene
108-38-3
200
para
-xylene
1,4-dimethylbenzene
106-42-3
Methyl Alcohol
methyl alcohol
methanol
67-56-1
100
1000
Isopropyl Alcohol
isopropanol
2-propanol
67-63-0
200
1000
Methylene Chloride
methylene chloride
dichloromethane
75-09-2
50
100
Acetone
acetone
2-propanone
67-64-1
200
1000
Residual Solvents Reporting Requirements for
								DOH Medical Cannabis Program
Use two significant digits when reporting
								residual solvent results.
Non-detects are reported as less than the Method
								Reporting Level for each residual solvent. Example: "Benzene < 2.0
								µg/g"
Note: The isomers meta-xylene and para-xylene
								cannot be separated chromatographically, so they are reported as a pair.
*Micrograms solvent per gram of sample (µg/g)
								is equivalent to parts per million (ppm).
(4)
Potency test:
A non-profit producer shall sample and test all
				dried usable cannabis, and a non-profit producer or manufacturer (as
				applicable) shall sample and test all concentrated cannabis derived products,
				for quantity of tetrahydrocannabinol (THC, tetrahydrocannabinolic acid (THCA),
				cannabidiol (CBD), cannabidiolic acid (CBDA), and also for THC potency and CBD
				potency, using an approved laboratory prior to sale, distribution, or other
				use. A non-profit producer may, at the producer's option, also test for
				quantity of cannabinol (CBN), cannabigerolic acid (CBGA), cannabigerol (CBG),
				cannabichromene (CBC), tetrahydrocannabivarin (THCV), and cannabidivarin
				(CBDV). The potency test shall be conducted in accordance with the testing
				requirements at Table 4, Potency Testing Requirements.
Table 4. Potency Testing
								Requirements
Cannabinoid
Abbreviation
CAS Number
Reporting Units*
Comments
Tetrahydrocannabinolic Acid
THCA
23978-85-0
mg/g and % (Percent)
analysis required by rule
Tetrahydrocannabinol
THC
1972-08-3
mg/g and % (Percent)
analysis required by rule
Cannabidiolic Acid
CBDA
1244-58-2
mg/g and % (Percent)
analysis required by rule
Cannabidiol
CBD
13956-29-1
mg/g and % (Percent)
analysis required by rule
THC Potency
THC Potency = Percent THCA x 0.877 + Percent
								THC
mg/g and % (Percent)
reporting required by the rule and calculation
								listed
CBD Potency
CBD Potency = Percent CBDA x 0.877 + Percent
								CBD
mg/g and % (Percent)
reporting required by the rule and calculation
								listed
Cannabinol
CBN
521-35-7
mg/g and % (Percent)
analysis optional, recommended for strain
								characterization
Cannabigerolic Acid
CBGA
25555-57-1
mg/g and % (Percent)
analysis optional, recommended for strain
								characterization
Cannabigerol
CBG
25654-31-3
mg/g and % (Percent)
analysis optional, recommended for strain
								characterization
Cannabichromene
CBC
20675-51-8
mg/g and % (Percent)
analysis optional, recommended for strain
								characterization
Tetrahydrocannabivarin
THCV
31262-37-0
mg/g and % (Percent)
analysis optional, recommended for strain
								characterization
Cannabidivarin
CBDV
24274-48-4
mg/g and % (Percent)
analysis optional, recommended for strain
								characterization
*Milligrams per gram (mg/g) of sample; this unit
								can be also expressed in percent composition of the sample.
A cannabis derived product shall be homogenous in composition
				  with respect to THC potency. A product shall be deemed non-homogenous if ten
				  percent of the infused portion of the product contains more than twenty percent
				  of the total THC contained in the product. In the event that a cannabis derived
				  product does not meet this requirement, the batch shall be wasted in accordance
				  with the provisions of this rule.
(5)
Heavy metal test:
A
				non-profit producer shall sample and test all dried usable cannabis, and a
				non-profit producer or manufacturer (as applicable) shall sample and test all
				concentrated cannabis derived products, for heavy metals, using an approved
				laboratory, prior to sale, distribution, or other use. A sample may be deemed
				to have passed the heavy metals test if the sample contains less than each
				action level set forth in Table 5, Heavy Metal Testing Requirements. The heavy
				metals test shall be conducted in accordance with the testing requirements at
				Table 5.
Table 5. Heavy Metal Testing
								Requirements
Heavy Metals
Elemental Symbol
IUPAC Name
CAS Number
Action Level
								(
µg/g
) or (ppm)*
Method Reporting Level
								(
µg/g
) or (ppm)*
Arsenic
As
arsenic
7440-38-2
2.0
0.2
Cadmium
Cd
cadmium
7440-43-9
0.8
0.2
Lead
Pb
lead
7439-92-1
1.2
0.2
Mercury
Hg
mercury
7439-97-6
0.4
0.1
*Micrograms per gram (µg/g) of sample is
								equivalent to parts per million (ppm).
(6)
Pesticide test:
A non-profit producer shall sample and test all
				dried usable cannabis, and a non-profit producer or manufacturer (as
				applicable) shall sample and test all concentrated cannabis derived products,
				for pesticide content using an approved laboratory prior to sale, distribution,
				or other use. A sample may be deemed to have passed the pesticide test if the
				sample contains less than each action level set forth in Table 6, Pesticide
				Testing Requirements. The pesticide test shall be conducted in accordance with
				the testing requirements at Table 6.
Table 6. Pesticide Testing
								Requirements
Targeted Pesticide
Common Chemical Name
CAS Number
Action Level
								(
µg/kg
)
Method Reporting Level
								(
µg/kg
)
Abamectin
avermectin B1a & avermectin B1b
71751-41-2
500
100
Azoxystrobin
azoxystrobin
131860-33-8
200
100
Bifenazate
bifenazate
149877-41-8
200
100
Etoxazole
etoxazole
153233-91-1
200
100
Imazalil
chloramizole
35554-44-0
200
100
Imidacloprid
imidacloprid
138261-41-3
400
100
Malathion
malathion
121-75-5
200
100
Myclobutanil
myclobutanil
88671-89-0
200
100
Permethrins
cis
-permethrin &
trans
-permethrin
52645-53-1
200
100
Spinosad
spinosyn A & spinosyn D
168316-95-8
200
100
Spiromesifen
spiromesifen
283594-90-1
200
100
Spirotetramat
spirotetramat
203313-25-1
200
100
Tebuconazole
tebuconazole
80443-41-0
400
100
*Micrograms of pesticide per kilogram
								(
µg/kg
) of sample is equivalent to parts per billion
								(ppb).
(7)
Moisture content test:
A non-profit producer shall sample and test
				all dried usable cannabis for moisture content using an approved laboratory
				prior to sale, distribution, or other use.
(8)
Random testing of finished cannabis
				derived products:
A non-profit producer or manufacturer that
				manufactures a cannabis derived product shall establish a schedule for, and
				shall conduct, random sampling and testing of finished, non-concentrated
				cannabis derived products, including but not limited to edible cannabis derived
				products, as follows:
(a) The non-profit
				producer or manufacturer shall randomly select and sample at and at least one
				percent of all non-concentrated cannabis derived product batches manufactured
				every week (and no less than one batch);
(b) The non-profit producer or manufacturer
				shall apply the sampling and testing standards that otherwise apply under this
				rule to dried cannabis and concentrated cannabis derived products;
				and
(c) In the event that a sample
				fails any of the required tests, the batch shall not be sold, distributed, or
				otherwise used, unless remediated in accordance with the remediation standards
				of this rule.
(9)
Additional testing:
The department may require additional testing of
				cannabis and cannabis derived products by non-profit producers and
				manufacturers, as it deems appropriate.