(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.
(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
|
|
Methorayl
|
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 l)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 trans-permethrin 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 B1, B2, G1, G2)
|
20 ppb
|
|
Ochratoxin A
|
20 ppb
|
(3) For cannabis, kief, hashish, and
pre-rolled cannabis flower products, 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
11-850-76 (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).
Notes
Haw. Code R. §
11-850-135
[Eff 12/14/15; §11-850-85; am, ren §
11-850-135, and
comp
2/24/2022] (Auth: HRS §§
321-9,
329D-7,
329D-8,
37W-9,
329D-27)
(Imp: HRS §§
329D-7,
329D-8,
329D-9,
329D-19;
SLH 2017, Act 170, §3)
Comp
4/29/2022
Am and comp
11/17/2022
Am
and comp 8/7/2023
Am
and comp 4/5/2024
Am and comp 12/6/2024
