HAR §11-850-132. handle or analyze cannabis or manufactured cannabis products unless that laboratory is certified by the department as specified in this subchapter, except as provided in subsection (d)

(b) The department may grant a certification to a laboratory to analyze cannabis and manufactured cannabis products if that laboratory: (1) Is independent from all medical cannabis dispensary licensees and employees and all other persons and entities with a financial interest in a dispensary licensee; (2) Is accredited in Hawaii by an accreditation body whose standards are equivalent to the International Standards for Organization (ISO) 17025, with a scope of accreditation that includes analytes listed in section 11-850-135(c) for cannabis and manufactured cannabis products; (3) Demonstrates capacity and proficiency to test cannabis and manufactured cannabis products in accordance with this chapter; (4) Has established standard operating procedures that include chain of custody for samples transferred to the laboratory or between laboratories for analysis; and (5) Has obtained a certification of registration from the department of public safety in accordance with section 329-32, HRS, and chapter 23-200. (c) The department may grant a provisional certification to a laboratory to analyze cannabis and manufactured cannabis products if that laboratory: (1) Is owned or operated by a laboratory that is accredited in another jurisdiction by an accreditation body whose standards are equivalent to the ISO 17025, with a scope of accreditation that includes cannabis and manufactured cannabis products; (2) Has applied to be ISO 17025 accredited in Hawaii by an accreditation body whose standards are equivalent to the International Standards for Organization 850-108 § 611 §11-850-133 (ISO), for a scope of accreditation that includes analytes listed in section 11-850-135(c) for cannabis and manufactured cannabis products; and (3) Meets the requirements in subsection (b)(1), (3), (4), and (5). (d) A laboratory applying for certification under this subchapter may handle and analyze samples of cannabis or manufactured cannabis products for the purpose of becoming certified pursuant to this subchapter provided the laboratory has obtained a certification of registration from the department of public safety in accordance with section 329-32, HRS, and chapter 23-200 prior to handling or analyzing samples. [Eff 12/14/15; §11-850-82; am, ren §11-850-132, and comp 2/24/22; comp 4/29/22; am and comp 11/17/22; comp 8/7/23; comp 4/5/24; comp 12/6/24; comp NOV 17 2025 ] (Auth: HRS §§321-9, 329D-7, 329D-8, 329D-9, 329D-27) (Imp: HRS §§329D-7, 329D-8, 329D-9; SLH 2017, Act 170, §3) ### §11-850-133 Procedures for laboratory certification. (a) To apply for a laboratory certification to analyze cannabis and manufactured cannabis products, a laboratory shall submit to the department on forms and in a manner prescribed by the department: (1) An application; (2) All information and documents required by the department, including but not limited to: (A) Laboratory employee qualifications; (B) Standard operating procedures; (C) Quality assurance plan; (D) Validation studies; (E) Annual proficiency tests; (F) A copy of the laboratory's most recent assessment by the laboratory's accreditation body, the laboratory's responses to any findings of non- 850-109 3611 §11-850-133 compliance with standards or recommendations, and the corrective actions taken by the laboratory to address the findings or recommendations; and (G) A copy of the laboratory's accreditation in Hawaii or another jurisdiction, accompanied by the scope of accreditation; and (3) An annual certification fee in the amount of $3,000. (b) As part of its review conducted prior to issuing certification to a laboratory, the department: (1) Shall conduct an on-site evaluation of a laboratory seeking initial certification or a laboratory seeking to meet the requirements of section 11-850-132(b) after a period of provisional certification; and (2) May conduct an on-site evaluation of a laboratory seeking renewal of certification. (c) The department may issue a certification to a laboratory that meets the applicable requirements set forth in this chapter, including the requirements of section 11-850-132(b). (d) The department may issue a provisional certification to a laboratory that meets the applicable requirements set forth in this chapter, including the requirements of section 11-850-132(c). (e) The department shall deny certification to any laboratory that does not meet the requirements set forth in this subchapter. (f) A laboratory certification pursuant to this subchapter shall expire one year after the date it is issued by the department. (g) To apply for renewal of a laboratory certification, a laboratory shall submit the application, information, documents, and fee required in subsection (a) no later than two months prior to expiration of its certification. [Eff 12/14/15; §11-850-83; am, ren §11-850-133, and comp 2/24/22; comp 4/29/22; am and comp 11/17/22; comp 8/7/23; comp 4/5/24; comp 12/6/24; comp NOV 17 2025 ] (Auth: HRS 850-110 3611. §11-850-134 §§321-9, 329D-7, 329D-8, 329D-9, 329D-27) (Imp: HRS §§329D-7, 329D-8, 329D-9; SLH 2017, Act 170, §3) ###