Hawaii Administrative Rules
Title 11 - DEPARTMENT OF HEALTH
Subtitle 1 - GENERAL DEPARTMENTAL PROVISIONS
Chapter 850 - MEDICAL CANNABIS DISPENSARIES
Subchapter 9 - LABORATORY CERTIFICATION, ANALYSIS, AND STANDARDS
Section 11-850-135 - Laboratory standards and analysis

Universal Citation: HI Admin Rules 11-850-135

Current through February, 2024

(a) A certified laboratory shall develop and follow a statistically valid sampling plan to collect representative samples from each batch of cannabis or manufactured cannabis product in accordance with section 11 850-131. A certified laboratory shall analyze a representative sample from each batch of cannabis or manufactured cannabis products.

(b) A certified laboratory shall analyze samples according to standard operating procedures prepared by the laboratory based on validated methods published in peer reviewed scientific or regulatory literature, subject to approval by the department, and shall document the accuracy, sensitivity, specificity, and reproducibility of the analysis methods.

(c) A certified laboratory shall issue to the dispensary licensee and the department a certificate of analysis for each batch of cannabis and manufactured cannabis products analyzed for that dispensary; provided that a certified laboratory may only analyze and report on those methods and analytes for which it is qualified. The certificate of analysis shall include the results with supporting data for the following:

(1) The chemical profile of the batch for the following cannabinoids:
(A) Total tetrahydrocannabinol;

(B) Delta-9-tetrahydrocannabinolic acid;

(C) Delta-9-tetrahydrocannabinol;

(D) Delta-8-tetrahydrocannabinol;

(E) Cannabidiol (CBD); and

(F) Any other cannabinoid specifically listed or described in the label or packaging of the cannabis or manufactured cannabis product, including but not limited to cannabigerol (CBG) and cannabinol (CBN).

(2) The presence of the following contaminants, which shall not exceed the specified concentration limits:
(A) Heavy metals listed in Table 3;

Table 3

Heavy metal

Limit (parts per million)

Arsenic

10.0 ppm

Cadmium

4. 0 ppm

Lead

6.0 ppm

Mercury

2.0 ppm

(B) Pesticides listed in Table 4, each with a limit of 1.0 parts per million (ppm);

Table 4

Pesticide

Chemical Abstracts

Service

Registry Number

(CAS No.)

Abamectin

71751-41-2

Acephate

30560-19-1

Acequinocyl

57960-19-7

Acetamiprid

135410-20-7

Aldicarb

116-06-3

Azoxystrobin

131860-33-8

Bifenazate

149877-41-8

Bifenthrin

82657-04-3

Boscalid

188425-85-6

Carbaryl

63-25-2

Carbofuran

1563-66-2

Chlorantraniliprole

500008-45-7

Chlorfenapyr

122453-73-0

Chlorpyrifos

2921-88-2

Clofentezine

74115-24-5

Cyfluthrin

68359-37-5

Cypermethrin

52315-07-8

DDVP (Dichlorvos)

62-73-7

Diazinon

333-41-5

Dimethoate

60-51-5

Ethoprophos

13194-48-4

Etofenprox

80844-07-1

Etoxazole

153233-91-1

Fenpyroximate

134098-61-6

Fipronil

120068-37-3

Flonicamid

158062-67-0

Fludioxonil

131341-86-1

Hexythiazox

78587-05-0

Imazalil

35554-44-0

Imidacloprid

138261-41-3

Kresoxim-methyl

143390-89-0

Malathion

121-75-5

Metalaxyl

57837-19-1

Methiocarb

2032-65-7

Methomyl

16752-77-5

Methyl parathion

298-00-0

MGK-264

113-48-4

Myclobutanil

88671-89-0

Naled

300-76-5

Oxamyl

23135-22-0

Paclobutrazol

76738-62-0

Permethrins (total of cis- and trans-permethrin isomers) 1

52645-53-1

Phosmet

732-11-6

Piperonyl butoxide

51-03-6

Prallethrin

23031-36-9

Propiconazole

60207-90-1

Propoxur

114-26-1

Pyrethrins (total of pyrethrin 1, cinerin 1, and jasmolin 1) 2

8003-34-7

Pyridaben

96489-71-3

Spinosad

168316-95-8

Spiromesifen

283594-90-1

Spirotetramat

203313-25-1

Tebuconazole

80443-41-0

Thiacloprid

111988-49-9

Thiamethoxam

153719-23-4

Trifloxystrobin

141517-21-7

Notes to Table 4:

1. Permethrins should be measured as cumulative residue of cis- and transpermethrin isomers (CAS numbers 54774 45-7 and 51877-74-8, respectively).

2. 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).

(C) For manufactured cannabis products, solvents listed in Table 5;

Table 5

Solvent

Chemical Abstracts Service Registry Number (CAS No.)

Limit (parts per million)

1,1-

Dichloroethene

75-35-4

8.0 ppm

1,1,1-

Trichloroethane

71-55-6

1,500 ppm

1,2-

Dichloroethane

107-06-2

1.0 ppm

Acetone

67-64-1

5000 ppm

Acetonitrile

75-05-8

410 ppm

Benzene

71-43-2

1.0 ppm

Butane

106-97-8

5000 ppm

Carbon

tetrachloride

56-23-5

4.0 ppm

Chloroform

67-66-3

1.0 ppm

Ethanol

64-17-5

5000 ppm

Ethyl acetate

141-78-6

5000 ppm

Ethyl ether

60-29-7

5000 ppm

Heptane

142-82-5

5000 ppm

Hexane

110-54-3

290 ppm

Isopropyl alcohol

67-63-0

5000 ppm

Methanol

67-56-1

3000 ppm

Methylene chloride

75-09-2

1.0 ppm

Pentane

109-66-0

5000 ppm

Propane

74 98-6

5000 ppm

Toluene

108-88-3

890 ppm

Total xylenes (ortho-, meta-, para-)

1330-20-7

2170 ppm

Trichloroethylene

79-01-6

1.0 ppm

(D) Any visible foreign or extraneous material, that is not intended to be part of the product being produced, including but not limited to mold, hair, insects, metal, or plastic;

(E) The following microbial contaminants, which must not be detected in one gram of cannabis or manufactured cannabis product:
(i) Escherichia coli;

(ii) Salmonella spp.;

(iii) Aspergillus fumigatus;

(iv) Aspergillus flavus;

(v) Aspergillus niger; and

(vi) Aspergillus terreus; and

(F) Mycotoxins listed in Table 6.

Table 6

Mycotoxin

Limit (parts per billion)

Aflatoxins (total of Bl, B2, Gl, G2)

20 ppb

Ochratoxin A

20 ppb

(3) For cannabis, kief, and hashish, water activity (aw), which shall not exceed 0.65; and

(4) Additional analyses requested at the discretion of the department.

(d) The certified laboratory may reanalyze the sample or analyze a different sample from the same batch by following its standard operating procedure to confirm or refute the original result, upon request by the dispensary licensee or upon request by the department at the dispensary licensee's expense, provided that no more than two re-analyses may be performed for the same batch.

(e) The certified laboratory shall return to the dispensary licensee or destroy in a manner approved by the department any samples or portions of samples of cannabis or manufactured cannabis products that remain after analysis is completed.

(f) A certified laboratory shall create records of analyses it conducts on cannabis and manufactured cannabis products, including but not limited to:

(1) The time and date the sample was obtained;

(2) A description of the sample, including the amount;

(3) What analyses were conducted on each sample;

(4) The results of the analyses including the certificate of analysis; and

(5) Evidence of the time, date, and method of destruction of a sample after analysis is completed, and the amount of sample destroyed, or the time and date a sample was returned to a dispensary with a description including the amount.

(g) A dispensary licensee shall ensure that each sample is analyzed for each of the analytes set out in subsection (c) and may obtain results from different laboratories for different analytes if one laboratory cannot perform all the analyses.

(h) The level of contaminants and water activity in cannabis and manufactured cannabis products shall not exceed the limits specified in subsection (c), and if any of the limits are exceeded, the dispensary licensee shall not dispense any portion of the batch of cannabis or manufactured cannabis product that does not conform to the standards; provided that:

(1) The following may be remediated in accordance with section 11-850-129:
(A) Cannabis or manufactured cannabis products that exceed the limits for heavy metals, foreign or extraneous material, microbial contaminants, mycotoxins, or water activity; and

(B) Manufactured cannabis products that exceed the limits for solvents or the dosage limits in section ll-850-76(f) or 11-850 142 (a) (5);

(2) The limit for ethanol does not apply to tinctures; and

(3) The limits for ethanol and isopropyl alcohol do not apply to ointments intended for topical application, skin lotions, and transdermal patches.

(i) A dispensary licensee shall dispose of or destroy any batch that does not conform to the standards set out in subsection (c) under video camera surveillance within thirty days; provided that a dispensary licensee shall quarantine a non-conforming batch until any reanalysis pursuant to subsection (d) or (h) is completed. The quarantine shall be lifted only by the department, and only following receipt by the department of a certificate of analysis indicating that the batch conforms to the standards set out in subsection (c).

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