N.M. Admin. Code § 7.34.4.10

Current through Register Vol. 35, No. 21, November 5, 2024

Section 7.34.4.10 - TESTING OF USABLE CANNABIS

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.

D.Release of batch after testing: A licensed non-profit producer or manufacturer may release an entire batch of dried cannabis or concentrated cannabis derived product for immediate manufacture, sale, or other use, provided that the sample taken from the batch passes the tests required in this section.

E.Procedures for testing: A licensed non-profit producer and a manufacturer shall ensure that the following testing procedures are followed:

(1) sampling and segregation: a licensed non-profit producer or manufacturer shall remove a sample of no less than the quantities of cannabis or cannabis derived product specified in Table 7, Minimum Test Sample Size, from every batch, and shall transfer the sample to an approved laboratory for testing; the remainder of the batch of dried, usable cannabis or concentrated cannabis-derived product shall be segregated until the licensed non-profit producer receives the results of laboratory testing report and determines whether the batch meets the testing requirements of this rule;

Table 7. Minimum Test Sample Size
Targeted Parameter	Sample Matrix	Analysis Platforms (Instrumentation Used by Lab)	Minimum Amount Required for Testing (grams)
Cannabis Potency	dried usable cannabis	HPLC, LCMS	1.0
	concentrated cannabis-derived products (CCDP)	HPLC, LCMS	1.0
	non-concentrated cannabis-derived products (NCCDP)	HPLC, LCMS	1.0
Cannabis Moisture Content	dried usable cannabis	n/a	1.0
Mycotoxins	dried usable cannabis, CCDP, or NCCDP	HPLC, LCMS, LCMSMS	1.0
Residual Solvents	CCDP	GC-FID, GC-PID/FID	1.0
	CCDP	GCMS	0.5
	NCCDP	GC-FID, GC-PID/FID	5.0
	NCCDP	GCMS	1.0
Absence of Salmonella spp. & E. coli	dried usable cannabis, NCCDP	Culture, biochemical, antibody, or nucleic acid- based assays shall be validated microbiological methodology such as FDA, USP, AOAC, or equivalent.	10.0
	CCDP		1.0
Total Aerobic Microbial Count	dried usable cannabis, CCDP, or NCCDP	Direct culture, indirect culture, or non-culture based. Must be validated microbiological methodology such as FDA, USP, AOAC, or equivalent.	10.0 (dried usable cannabis and NCCDP) 1.00 (CCDP)
Total Combined Yeast & Mold Count
Bile-tolerant Gram-negative Bacteria
Total Coliforms Count
Pesticides	dried usable cannabis	HPLC, LCMS, LCMSMS	2.0
Heavy Metals	dried usable cannabis, CCDP, NCCDP	ICP-MS, FIMS	0.5
Minimum required test size for CCDP = 8 g, Minimum required test sample size for NCCDP = 27.5g, Minimum required test sample size for dried usable cannabis = 25.5 g. Minimum test sample size may change if a validated method is approved by NMDOH MCP

(2)sample selection: a non-profit producer and manufacturer shall collect and submit samples for testing that are representative of the batch being tested; the department may order that a non-profit producer or manufacturer modify its sampling collection practices if it has reason to believe that samples that were previously collected were not representative of an associated batch;

(3) documentation: a non-profit producer and a manufacturer shall appropriately document the sampling and testing of all dried cannabis and concentrated cannabis-derived product, and shall utilize a department approved laboratory for the purpose of testing usable cannabis;

(4)preservation and inspection of testing records: a licensed non-profit producer and a manufacturer shall maintain all results of laboratory tests conducted on cannabis or cannabis derived products produced by the licensed non-profit producer or manufacturer or their contractor for a period of at least two years, and shall make those results available to qualified patients and primary caregivers enrolled in the medical cannabis program upon request; and

(5)disciplinary action: repeated failure to pass testing may result in the imposition of disciplinary action(s) by the department, consistent with this rule.

F.Remediation; subsequent testing: If a sample fails a given test (i.e., if the sample does not measure below the action levels specified in this rule), the non-profit producer or manufacturer (as applicable) shall determine whether remediation is appropriate, and may pursue confirmatory testing at another approved laboratory. In the event that a non-profit producer or manufacturer attempts to remediate cannabis or a cannabis derived product, the batch shall again be sampled and subjected to all of the tests identified in this rule, except those required for heavy metals and pesticides. A batch of usable cannabis that fails a given test and that does not pass the required tests subsequent to remediation conducted in accordance with the terms of this rule, shall be destroyed in accordance with the wastage requirements of this rule. A non-profit producer or manufacturer may remediate cannabis or cannabis derived product in accordance with the following:

(1)Dried usable cannabis: A non-profit producer may remediate dried usable cannabis that has failed a microbiological test, by utilizing extraction or distillation methods that remove or reduce contaminants in the batch such that a subsequent sample from the batch measures within the action levels of a required test. A non-profit producer may not remediate dried usable cannabis that fails any other test required by this rule;

(2)Cannabis derived product: A non-profit producer or manufacturer (as applicable) may remediate a non-edible cannabis derived product (including concentrated product) that has failed a microbiological test or residual solvent test by utilizing extraction or distillation methods that remove or reduce contaminants in the batch such that a subsequent sample from the batch measures within the action levels of a required test. A non-profit producer or manufacturer may not remediate non-edible cannabis derived product that fails any other test required by this rule.

(3)Edible cannabis derived product: A non-profit producer or manufacturer may not remediate an edible cannabis derived product. Edible cannabis derived products include brownies, cookies, candies, and similar finished products intended for human consumption.

(4)Notice and wastage: If the batch of usable cannabis cannot be remediated such that the sample measures within the action levels of a required test, the non-profit producer or manufacturer shall notify the department 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 tracked in an electronic system specified by the department.

(5)Testing and remediation protocols: A non-profit producer and a manufacturer shall adopt and maintain on the premises protocols regarding sampling, sample testing, remediation, and retesting, consistent with this rule.

N.M. Admin. Code § 7.34.4.10

7.34.4.10 NMAC - N, 12/30/2010, Amended by New Mexico Register, Volume XXVI, Issue 04, February 27, 2015, eff. 2/27/2015, Adopted by New Mexico Register, Volume XXXI, Issue 12, June 23, 2020, eff. 6/23/2020