§503. Operation of testing facilities
A testing facility must be operated in accordance with the provisions of this section and the rules adopted pursuant to this chapter.
[PL 2017, c. 409, Pt. A, §6 (NEW).]
1.
Development, research and testing of cannabis, cannabis products and other substances.
A testing facility may develop, research and test cannabis and cannabis products for:
A.
That facility;
[PL 2017, c. 409, Pt. A, §6 (NEW).]
B.
Another licensee;
[PL 2017, c. 409, Pt. A, §6 (NEW).]
C.
A person who intends to use the cannabis or cannabis product for personal use as authorized under chapter 3; or
[PL 2017, c. 409, Pt. A, §6 (NEW); PL 2021, c. 669, §5 (REV).]
D.
A qualifying patient, a caregiver, a registered caregiver or a registered dispensary.
[PL 2017, c. 409, Pt. A, §6 (NEW); PL 2017, c. 452, §37 (REV).]
Neither this chapter nor the rules adopted pursuant to this chapter prevent a testing facility from developing, researching or testing substances or products that are not cannabis or cannabis products for that facility or for another person.
[PL 2023, c. 679, Pt. B, §76 (AMD).]
2.
Certification; accreditation and provisional licensure; compliance with operational and technical requirements.
A testing facility may not commence or continue operation unless the testing facility:
A.
Is certified for operation under the certification program within the Department of Health and Human Services, Maine Center for Disease Control and Prevention established pursuant to Title 22, section 569 and, in accordance with rules adopted by the office after consultation with the Department of Health and Human Services, Maine Center for Disease Control and Prevention, which must allow for inspection of the proposed or operational testing facility by the office and the Department of Health and Human Services, Maine Center for Disease Control and Prevention;
[PL 2023, c. 679, Pt. B, §77 (AMD).]
B.
Except as otherwise provided in this paragraph, is accredited pursuant to standard ISO/IEC 17025 of the International Organization for Standardization by a 3rd-party accrediting body or is certified, registered or accredited by an organization approved by the office. The office shall adopt rules regarding the scope of certification, registration or accreditation required for licensure of a testing facility.
(1)
The office may issue a full testing facility license to an applicant that meets all applicable requirements of this chapter and rules adopted pursuant to this chapter and that has obtained accreditation pursuant to standard ISO/IEC 17025 of the International Organization for Standardization from a 3rd-party accrediting body or that is certified, registered or accredited by an approved organization.
(2)
The office may issue a provisional testing facility license to an applicant that otherwise meets all applicable requirements of this chapter and rules adopted pursuant to this chapter and that has applied for but not yet obtained accreditation from a 3rd-party accrediting body or that has applied for but not yet obtained certification, registration or accreditation from an approved organization. The office may not renew a provisional testing facility license more than once.
An active full or provisional testing facility license may not be issued by the office to an applicant until the applicant satisfies all applicable requirements of section 205, subsection 4; and
[PL 2023, c. 679, Pt. B, §77 (AMD).]
C.
Is determined by the office to meet all operational and technical requirements for testing facilities under this chapter and the rules adopted under this chapter.
[PL 2023, c. 679, Pt. B, §77 (AMD).]
[PL 2023, c. 679, Pt. B, §77 (AMD).]
3.
Compliance with testing protocols, standards and criteria.
A testing facility shall follow all testing protocols, standards and criteria adopted by rule by the office for the testing of different forms of cannabis and cannabis products; determining batch size; sampling; testing validity; and approval and disapproval of tested cannabis and cannabis products. A testing facility may use a sample collector for the collection of samples for mandatory testing as long as the testing facility's operating plan and standard operating procedures indicate the use of a sample collector for that purpose.
[RR 2023, c. 2, Pt. A, §43 (COR).]
4.
Remediation and retesting.
If a testing facility determines that a sample of adult use cannabis or an adult use cannabis product has failed a mandatory test required under section 602, the testing facility shall offer to the owner of that sample an opportunity for remediation and retesting in accordance with rules adopted by the office.
[PL 2023, c. 679, Pt. B, §79 (AMD).]
4-A.
Retesting for potency.
If requested by the licensee, a testing facility may retest for potency a sample of adult use cannabis or an adult use cannabis product from the same batch the testing facility initially tested. The retest for potency may be completed only once after the initial test, and the sample must be from the remaining representative sample of the same batch that was initially received by the testing facility. The results of the initial test and the retest must be reported by the testing facility in accordance with subchapter 6 and the rules governing testing facilities. A licensee that chooses to retest for potency shall include the potency values reported for the retest instead of the initial potency value reported by the testing facility.
[PL 2023, c. 679, Pt. B, §80 (NEW).]
5.
Record keeping.
A testing facility shall maintain records of all business transactions and testing results in accordance with the record-keeping requirements of section 511 and section 602, subsection 2 and in accordance with applicable standards for licensing and accreditation under subsection 2 and testing protocols, standards and criteria adopted by the office under subsection 3.
[PL 2023, c. 679, Pt. B, §81 (AMD).]
6.
Disposal of cannabis and cannabis products.
A testing facility shall dispose of or destroy used, unused and waste cannabis and cannabis products in accordance with rules adopted by the office.
[PL 2023, c. 679, Pt. B, §82 (AMD).]
7.
Notification of test results.
A testing facility shall notify the office of test results in accordance with section 603.
[PL 2023, c. 679, Pt. B, §83 (AMD).]
8.
Independence of testing facility interest.
A person with an interest in a testing facility may not be a caregiver or a registered caregiver or have an interest in a registered dispensary, a cannabis store license, a cultivation facility license or a products manufacturing facility license, but may hold or have an interest in multiple testing facility or sample collector licenses. A person who is a caregiver or a registered caregiver or who has an interest in a registered dispensary, a cannabis store license, a cultivation facility license or a products manufacturing facility license may not have an interest in a testing facility or sample collector license. As used in this subsection, "interest" has the same meaning as in section 205, subsection 2, paragraph B.
[PL 2019, c. 676, §12 (AMD); PL 2021, c. 669, §5 (REV).]
9.
Tracking.
In accordance with the requirements of section 105, a testing facility licensee shall track all adult use cannabis and adult use cannabis products it receives from a licensee for testing purposes from the point at which the cannabis or cannabis products are delivered or transferred to the testing facility to the point at which the cannabis or cannabis products are disposed of or destroyed.
[PL 2017, c. 409, Pt. A, §6 (NEW); PL 2021, c. 669, §5 (REV).]
10.
Rules.
The office shall adopt rules regarding the provisional licensure, licensure, certification and accreditation of testing facilities and the testing of cannabis and cannabis products by testing facilities pursuant to this chapter, including, but not limited to, rules establishing acceptable testing and research practices for testing facilities, including, but not limited to, provisions relating to testing practices, methods and standards; remediation and retesting procedures; quality control analysis; equipment certification and calibration; chemical identification; testing facility record-keeping, documentation and business practices; disposal of used, unused and waste cannabis and cannabis products; and reporting of test results. Rules adopted pursuant to this section are routine technical rules as defined in Title 5, chapter 375, subchapter 2‑A.
[PL 2023, c. 679, Pt. B, §84 (AMD).]
SECTION HISTORY
PL 2017, c. 409, Pt. A, §6 (NEW). PL 2017, c. 452, §37 (REV). PL 2019, c. 354, §8 (AMD). PL 2019, c. 491, §3 (AMD). PL 2019, c. 676, §§11, 12 (AMD). PL 2021, c. 669, §5 (REV). PL 2023, c. 679, Pt. B, §§76, 77, 79-84 (AMD). RR 2023, c. 2, Pt. A, §43 (COR).