ARM 42.39.614
ARM 42.39.614
Cite as Mont. Admin. R. 42.39.614
37.107.316 TESTING LABORATORY QUALITY ASSURANCE TESTING REQUIREMENTS
(1) Except as provided in (10), a licensee must submit for testing a sample of every test batch from a harvest lot of marijuana and process lots of marijuana-infused products, extracts, and concentrates intended for use by a customer prior to selling or transferring the marijuana item to a customer.
(2) All marijuana items intended for direct sale or transfer to customers shall be tested in its final form. The addition of any ingredient after final quality assurance compliance testing will require retesting.
(3) The cannabinoid profile/potency for each sample must include:
(a) THCA;
(b) THC;
(c) Total potential psychoactive THC for marijuana items that require the application of heat for administration/consumption only;
(d) CBDA; and
(e) CBD.
(4) The laboratory test sample and related lot or test batch fail quality assurance testing for moisture analysis if the results are greater than 12.0%.
(5) The laboratory test sample and related lot or test batch fail quality assurance testing for filth and foreign matter screening if the results are greater than the following action levels:
(a) 5.0% of stems 3mm or more in diameter; and
(b) 2.0% of seeds or other foreign matter.
(6) The laboratory test sample and related lot or test batch fail quality assurance testing for microbiological screening if the results are greater than the following action levels:
(a) Salmonella species: non-detectable in 1.0 gram of material;
(b) Shiga-toxin producing Escherichia coli (STEC): non-detectable in 1.0 gram of material; an d
(c) Pathogenic Aspergillus species A. flavus, A. fumigatus, A. niger, and A. terreus : Each non-detectable in 1.0 gram of material.
(7) Microbiological testing using molecular methods must include an enrichment step that follows the protocol provided by the manufacturer, molecular method used, or product instructions for use. Decreasing the enrichment time outside of the range provided above is strictly prohibited.
(8) The laboratory test sample and related lot fail quality assurance testing for mycotoxins if the results are greater than the following action level:
(a) Total of Aflatoxin B1, B2, G1, G2: 20 µg/kg; and
(b) Ochratoxin A: 20 µg/kg of substance.
(9) A laboratory test sample and related lot or test batch fail quality assurance testing for residual solvents if the results are greater than the action levels provided in table 1.0.
Table 1.0
Residual Solvents
(CAS) Registry Number
Action Level ppm
Acetone
67-64-1
5,000
Benzene
71-43-2
2
Total Butanes
See 1
5,000
* n-butane
106-97-8
* iso-butane
75-28-5
Chloroform
67-66-3
2
Cyclohexane
110-82-7
3,880
Dichloromethane
75-09-2
600
Ethyl acetate
141-78-6
5,000
Heptane
142-82-5
5,000
Total Hexanes
See 2
290
* n-hexane
110-54-3
* 2-methylpentane
107-83-5
* 3-methylpentane
96-14-0
* 2,2-dimethylbutane
75-83-2
* 2,3-dimethylbutane
79-29-8
Isopropanol (2-propanol)
67-63-0
5,000
Methanol
67-56-1
3,000
Total Pentanes
See 3
5,000
* n-pentane
109-66-0
* iso-pentane
78-78-4
* neo-pentane
463-82-1
Propane
74-98-6
5,000
Toluene
108-88-3
890
Total Xylenes
See 4
2,170
* 1,2-dimethylbenzene
95-47-6
* 1,3-dimethylbenzene
108-38-3
* 1,4-dimethylbenzene
106-42-3
1 Total butanes should be calculated as sum of n-butane and iso-butane.
2 Total hexanes should be calculated as sum of n-hexane, 2-methylpentane, 3-methylpentane, 2,2-dimethylbutane and 2,3-dimethylbutane.
3 Total pentanes should be calculated as sum of n-pentane, iso-pentane, and neo-pentane.
4 Total xylenes should be calculated as sum of 1,2-dimethylbenzene, 1,3-dimethylbenzene, and 1,4-dimethylbenzene.
(10) Heavy metals will be tested at random. A laboratory test sample and related lot or test batch fail quality assurance testing for heavy metals if the results are greater than the action levels provided in table 2.0.
Table 2.0
Heavy Metals
Action Level ppm; Inhalable Marijuana Items
Action Level ppm; Other Marijuana Items
Inorganic Arsenic
0.2
1.5
Cadmium
0.2
0.5
Lead
0.5
0.5
Mercury
0.1
3.0
(11) A laboratory test sample and related lot or test batch fail quality assurance testing for pesticides if the results are greater than the action levels provided in table 3.0.
Table 3.0
Pesticides
(CAS) Registry Number
Action Level ppm; Dry Flower
Action Level ppm; Concentrates and Extracts
Abamectin
71751-41-2
0.5
2.5
Acequinocyl
57960-19-7
2
10
Bifenazate
149877-41-8
0.2
1
Bifenthrin
82657-04-3
0.2
1
Chlormequat Chloride
999-81-5
1
5
Cyfluthrin
68359-37-5
1
5
Daminozide
1596-84-5
1
5
Etoxazole
153233-91-1
0.2
1
Fenoxycarb
72490-01-8
0.2
1
Imazalil
35554-44-0
0.2
1
Imidacloprid
138261-41-3
0.4
2
Myclobutanil
88671-89-0
0.2
0.6
Paclobutrazol
76738-62-0
0.4
2
Pyrethrinsâ€
8003-34-7
1
5
Spinosad
168316-95-8
0.2
1
Spirotetramat
203313-25-1
0.2
1
Trifloxystrobin
141517-21-7
0.2
1
†Pyrethrins should be measured as the cumulative residues of pyrethrin 1, cinerin 1, and jasmolin 1 (CAS numbers 121-21-1, 25402-06-6, and 4466-14-2 respectively).
(12) Licensees must adhere to testing requirements for all marijuana and marijuana products intended for sale or transfer to customers.
(a) Usable marijuana, including trim and manicure must be tested for:
(i) pesticides;
(ii) moisture content;
(iii) cannabinoid profile/potency;
(iv) microbiological;
(v) mycotoxin;
(vi) filth and foreign matter; and
(vii) heavy metals (random testing).
(b) A licensee has the option to forgo testing of usable marijuana, including trim and manicure, if that usable marijuana is subject to further processing before sale or transfer to customers.
(c) Marijuana extract and concentrate that is intended for direct sale or transfer to customers must be tested for:
(i) pesticides;
(ii) cannabinoid profile/potency;
(iii) microbiological;
(iv) mycotoxin;
(v) heavy metals (random testing); and
(vi) residual solvents.
(d) Marijuana extract and concentrate that is intended for further processing before direct sale or transfer to customers must be tested for:
(i) pesticides;
(ii) residual solvents;
(iii) mycotoxin; and
(iv) heavy metals (random testing).
(e) Marijuana infused products intended for human consumption, ingestion, or used as suppositories, topicals, and transdermal patches must be tested for:
(i) cannabinoid profile/potency; and
(ii) microbiological.
(f) All marijuana products listed in (e) must use marijuana extract and concentrate that has passed quality assurance testing requirements as set forth in (d).