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Rule Title: TESTING LABORATORY QUALITY ASSURANCE TESTING REQUIREMENTS
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Department: REVENUE
Chapter: CANNABIS CONTROL
Subchapter: Testing Laboratories
 
Latest version of the adopted rule presented in Administrative Rules of Montana (ARM):

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42.39.614    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; and

(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

See1

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

See2

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

See3

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

See4

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

Pyrethrins†

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). 

 

History: 16-12-202, 16-12-209, MCA; IMP, 16-12-202, 16-12-209, MCA; NEW, 2019 MAR p. 1868, Eff. 10/19/19; AMD, 2022 MAR p. 58, Eff. 1/15/22; TRANS, from ARM 37.107.316, 2023 MAR p. 570, Eff. 7/2/23.


 

 
MAR Notices Effective From Effective To History Notes
42-1066 7/2/2023 Current History: 16-12-202, 16-12-209, MCA; IMP, 16-12-202, 16-12-209, MCA; NEW, 2019 MAR p. 1868, Eff. 10/19/19; AMD, 2022 MAR p. 58, Eff. 1/15/22; TRANS, from ARM 37.107.316, 2023 MAR p. 570, Eff. 7/2/23.
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