Operation of testing facilities

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§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 marijuana, marijuana products and other substances.  A testing facility may develop, research and test marijuana and marijuana 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 marijuana or marijuana product for personal use as authorized under chapter 3; or   [PL 2017, c. 409, Pt. A, §6 (NEW).]

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 that are not marijuana or marijuana products for that facility or for another person.  

[PL 2017, c. 409, Pt. A, §6 (NEW); PL 2017, c. 452, §37 (REV).]

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 department 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 department and the Department of Health and Human Services, Maine Center for Disease Control and Prevention;   [PL 2019, c. 354, §8 (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 department. The department shall adopt rules regarding the scope of certification, registration or accreditation required for licensure of a testing facility.  

(1) The department 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 department 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 department 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 department to an applicant until the applicant satisfies all applicable requirements of section 205, subsection 4; and   [PL 2017, c. 409, Pt. A, §6 (NEW).]

C. Is determined by the department to meet all operational and technical requirements for testing facilities under this chapter and the rules adopted under this chapter.   [PL 2017, c. 409, Pt. A, §6 (NEW).]

[PL 2019, c. 354, §8 (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 department for the testing of different forms of marijuana and marijuana products; determining batch size; sampling; testing validity; and approval and disapproval of tested marijuana and marijuana 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.  

[PL 2019, c. 676, §11 (AMD).]

4.  Remediation and retesting.  If a testing facility determines that a sample of adult use marijuana or an adult use marijuana 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 department.  

[PL 2017, c. 409, Pt. A, §6 (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 department under subsection 3.  

[PL 2017, c. 409, Pt. A, §6 (NEW).]

6.  Disposal of marijuana and marijuana products.  A testing facility shall dispose of or destroy used, unused and waste marijuana and marijuana products in accordance with rules adopted by the department.  

[PL 2017, c. 409, Pt. A, §6 (NEW).]

7.  Notification of test results.  A testing facility shall notify the department of test results in accordance with section 603.  

[PL 2017, c. 409, Pt. A, §6 (NEW).]

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 marijuana 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 marijuana 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).]

9.  Tracking.  In accordance with the requirements of section 105, a testing facility licensee shall track all adult use marijuana and adult use marijuana products it receives from a licensee for testing purposes from the point at which the marijuana or marijuana products are delivered or transferred to the testing facility to the point at which the marijuana or marijuana products are disposed of or destroyed.  

[PL 2017, c. 409, Pt. A, §6 (NEW).]

10.  Rules.  The department shall adopt rules regarding the provisional licensure, licensure, certification and accreditation of testing facilities and the testing of marijuana and marijuana 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 marijuana and marijuana 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 2019, c. 491, §3 (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).


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