Section 11-850-135 - Laboratory standards and analysis(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) Oelta-9-tetrahydrocannabinolic acid;(C) Oelta-9-tetrahydrocannabinol;(D) Oelta-8-tetrahydrocannabinol;(E) Cannabidiol (CBO); 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 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 | 8 90 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:(iii)Aspergillus fumigatus;(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).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)