A laboratory must apply for the commissioner's approval on a form provided by the commissioner.
A laboratory must also submit the following items:
a signed and notarized attestation:
declaring any conflict of interest, actual or perceived, relating to its direct or indirect financial interests in any medical cannabis manufacturer form; and
demonstration of laboratory capability and acceptable performance through a combination of:
documented and acceptable proficiency testing samples from an approved provider, where available;
the name and educational qualifications of at least one technical manager responsible for the laboratory achieving and maintaining the quality and analytical standards of practice.
A mobile laboratory is considered a separate laboratory and is subject to all requirements of parts 4770.1900 to 4770.2300. In addition to the requirements of subpart 1, a mobile laboratory must:
submit a vehicle identification number, license plate number, or other uniquely identifying information to the commissioner when applying for approval; and
designate which fields of testing, equipment, and personnel are associated with the mobile laboratory.
The commissioner must evaluate completed applications using the following criteria.
A laboratory must operate formal management systems under the International Organization for Standardization (ISO). The ISO/IEC 17025, General Requirements for the Competency of Testing and Calibration Laboratories, includes technical and management system requirements which are incorporated by reference in part 4770.2800.
A laboratory seeking initial or renewal medical cannabis laboratory approval after December 31, 2016, must be accredited to Standard ISO/IEC 17025:2005, which is incorporated by reference.
A laboratory must specify one or more fields of testing for which it seeks approval. A laboratory must be approved for at least one field of testing to test medical cannabis for a medical cannabis manufacturer.
The commissioner must approve or deny the application within 60 days of receiving the completed application and any applicable information required under part 4770.2000, subpart 1, and subpart 2.
No board member, officer, employee, or other person with a financial interest in a medical cannabis manufacturer may have an interest or voting rights in the laboratory.
39 SR 1080; 40 SR 1599
June 20, 2016
Official Publication of the State of Minnesota
Revisor of Statutes