Montana Code Annotated 2019



Part 3. Montana Medical Marijuana Act

Testing Laboratories -- Licensing Inspections

50-46-311. Testing laboratories -- licensing inspections. (1) (a) The state laboratory shall license testing laboratories that meet the requirements of this part. The state laboratory shall inspect a testing laboratory before issuing or renewing a license. The state laboratory may not issue a temporary license while an inspection is pending.

(b) Inspections conducted for licensure or renewal of licensure must include a review of an applicant's or testing laboratory's:

(i) physical premises where testing will be conducted;

(ii) instrumentation;

(iii) protocols for sampling, handling, testing, reporting, security and storage, and waste disposal;

(iv) raw data on tests conducted by the laboratory, if the inspection is for renewal of a license; and

(v) vehicles used for transporting marijuana or marijuana-infused products samples for testing purposes.

(2) A testing laboratory shall:

(a) measure the tetrahydrocannabinol, tetrahydrocannabinolic acid, cannabidiol, and cannabidiolic acid content of marijuana and marijuana-infused products; and

(b) test marijuana and marijuana-infused products for pesticides, solvents, moisture levels, mold, mildew, and other contaminants. A testing laboratory may transport samples to be tested.

(3) The analytical laboratory services provided by the department of agriculture pursuant to 80-1-104 may be used for the testing provided for in this section.

(4) A person with a financial interest in a licensed testing laboratory may not have a financial interest in any entity involved in the cultivation of marijuana or manufacture of a marijuana-infused product or marijuana concentrate for whom testing services are performed.

(5) Each licensed testing laboratory shall employ a scientific director who is responsible for ensuring the achievement and maintenance of quality standards of practice. The scientific director must have the following minimum qualifications:

(a) a doctorate in chemical or biological sciences from a college or university accredited by a national or regional certifying authority and a minimum of 2 years of postdegree laboratory experience; or

(b) a master's degree in chemical or biological sciences from a college or university accredited by a national or regional certifying authority and a minimum of 4 years of postdegree laboratory experience.

(6) All owners and employees of a testing laboratory shall submit fingerprints to the state laboratory to facilitate a fingerprint and background check by the department of justice and the federal bureau of investigation. A testing laboratory may not be owned, operated, or staffed by a person who has been convicted of a felony offense.

(7) To qualify for licensure, a testing laboratory shall demonstrate that:

(a) staff members are proficient in operation of the laboratory equipment; and

(b) the laboratory:

(i) maintains the equipment and instrumentation required by rule;

(ii) has all equipment and instrumentation necessary to certify results that meet the quality assurance testing requirements established by rule, including the ability to certify results at the required level of sensitivity;

(iii) meets insurance and bonding requirements established by rule;

(iv) has the capacity and ability to serve rural areas of the state; and

(v) has passed a relevant proficiency program that demonstrates it is able to meet all testing requirements. The state laboratory shall establish by rule the proficiency programs considered relevant for the purposes of this section.

(8) Except as provided in 50-46-326(1)(b), a testing laboratory shall conduct tests of:

(a) samples of marijuana, marijuana concentrate, and marijuana-infused products submitted by providers and marijuana-infused products providers pursuant to 50-46-326 and related administrative rules prior to sale of the marijuana or marijuana-infused products;

(b) samples of marijuana or marijuana-infused products collected by the department during inspections of registered premises; and

(c) samples submitted by registered cardholders.

History: En. Sec. 22, I.M. No. 182, approved Nov. 8, 2016; amd. Sec. 6, Ch. 408, L. 2017; amd. Sec. 15, Ch. 292, L. 2019; amd. Sec. 4, Ch. 411, L. 2019.