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Rule Title: MARIJUANA TESTING LABORATORY QUALITY ASSURANCE TESTING REQUIREMENTS
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Department: PUBLIC HEALTH AND HUMAN SERVICES
Chapter: MARIJUANA REGISTRY
Subchapter: Testing Laboratories
 
Latest version of the adopted rule presented in Administrative Rules of Montana (ARM):

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37.107.316    MARIJUANA TESTING LABORATORY QUALITY ASSURANCE TESTING REQUIREMENTS

(1) Except as provided in (10), a provider 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 registered cardholder prior to selling or transferring the marijuana item to a registered cardholder.

(2) Usable marijuana lots consisting of dried leaves and flowers must be tested for the following:

(a) cannabinoid profile;

(b) moisture analysis;

(c) foreign matter screening;

(d) microbiological screening; and

(e) pesticides screening.

(3) Marijuana concentrate and extract lots must be tested for the following:

(a) cannabinoid profile;

(b) microbiological screening;

(c) residual solvents screening; and

(d) pesticides screening.

(4) Marijuana-infused products must be tested for the following:

(a) cannabinoid profile; and

(b) microbiological screening.

(5) The cannabinoid profile for each sample must include:

(a) THCA;

(b) THC;

(c) Total THC;

(d) CBDA;

(e) CBD; and

(f) Total CBD.

(6) The sample and related lot or test batch fail quality assurance testing for moisture analysis if the results exceed moisture content of greater than 12.0 percent.

(7) The sample and related lot or test batch fail quality assurance testing for foreign matter screening if the results exceed the following limits:

(a) five percent of stems 3mm or more in diameter; and

(b) two percent of seeds or other foreign matter.

(8) The sample and related lot or test batch fail quality assurance testing for microbiological screening if the results exceed the following limits:

(a) Salmonella: non-detectable in a gram of material;

(b) E. Coli: non-detectable in a gram of material;

(c) Culturable Mold: more than 10,000 colony forming units (CFU) per gram of material;

(d) Total of Aflatoxin B1, B2, G1, G2: 20 g/kg; and

(e) Ochratoxin A: 20 g/kg of substance.

(9) A sample and related lot or test batch fail quality assurance testing for residual solvents if the results exceed the limits provided in the table below.

Chemical Abstract Services

Residual Solvents

(CAS) Registry Number

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 sample and related lot or test batch fail quality assurance testing for heavy metals if the results exceed the limits provided in the table below.

Heavy Metals

Limits; Unprocessed/Dry Flower

Limits; Extract

Inorganic arsenic

2.0 g/g

10 g/g

Cadmium

0.82 g/g

4.1 g/g

Lead

1.2 g/g

6.0 g/g

Mercury

0.4 g/g

2.0 g/g

(11) A sample and related lot or test batch fail quality assurance testing for pesticides if the results exceed the limits provided in the table below.

Pesticides

Analyte

Chemical Abstract Services (CAS) Registry Number

Action Level ppl; Unprocessed/Dry Flower

Action Level ppm; Extract

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 Choloride

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) Providers must adhere to testing requirements for all marijuana and marijuana products intended for sale or transfer to cardholders.

(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 provider 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 cardholders.

(c) Marijuana extract and concentrate that is intended for direct sale or transfer to cardholders 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 cardholders must be tested for:

(i) pesticides;

(ii) residual solvents;

(iii) mycotoxin; and

(iv) heavy metals (random testing).

(e) Cannabinoid products intended for human consumption, ingestion, and cannabinoid suppositories, topicals, and transdermal patches must be tested for:

(i) cannabinoid profile; and

(ii) microbiological.

(f) All cannabinoid products listed in (e) must use marijuana extract and concentrate that has passed quality assurance testing requirements as set forth in (d).

History: 50-46-344, MCA; IMP, 50-46-303, 50-46-304, 50-46-308, 50-46-311, 50-46-326, 50-46-344, MCA; NEW, 2019 MAR p. 1868, Eff. 10/19/19.


 

 
MAR Notices Effective From Effective To History Notes
37-889 10/19/2019 Current History: 50-46-344, MCA; IMP, 50-46-303, 50-46-304, 50-46-308, 50-46-311, 50-46-326, 50-46-344, MCA; NEW, 2019 MAR p. 1868, Eff. 10/19/19.
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