Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Marijuana Regulatoty Agency › MARIHUANA SAMPLING AND TESTING › Section R. 420.305 - Testing; laboratory requirements

Current through Vol. 24-12, July 15, 2024
Rule 5.
(1) A
				laboratory shall become accredited for all required safety tests in at least 1
				matrix to the International Organization for Standardization (ISO), ISO/IEC
				17025:2017, by an International Laboratory Accreditation Cooperation (ILAC)
				recognized accreditation body or by an entity approved by the agency within 1
				year after the date the laboratory license is issued and agree to have the
				inspections, reports, and all scope documents sent to the agency.
(2) A laboratory shall use analytical testing
				methodologies for the required safety tests in subrule (3) of this rule that
				are based upon published peer-reviewed methods, have been validated for
				cannabis testing by an independent third party, and have been internally
				verified by the licensed laboratory according to Appendix J or K of Official
				Methods of Analysis authored by the Association of Official Analytical
				Collaboration (AOAC) International, with guidance from published cannabis
				standard method performance requirements where available. In the absence of
				published, peer reviewed, validated cannabis methods, method validation
				requirements of Appendix J or K of Official Methods of Analysis authored by the
				Association of Official Analytical Collaboration (AOAC) International must be
				met in full with guidance from published cannabis standard method performance
				requirements where available. The agency may monitor a laboratories analytical
				testing methodologies on an ongoing basis.
(3) A laboratory shall conduct the required
				safety tests specified in subdivisions (a) to (i) of this subrule on marihuana
				product that is part of the harvest batch or production batch as specified in R
				420.303, except as provided in subrule (4) of this rule. The minimum testing
				portions to be used in compliance testing shall be consistent with the testing
				portions used during method validation. The agency may publish a guide
				indicating which of the following safety tests are required based on product
				type when the marihuana product has changed form:
(a) Potency analysis. All of the following
				apply to a potency analysis under this subdivision:
(i) In the preparation of samples intended
				for potency analysis, the laboratory may not adulterate or attempt to
				manipulate the total potency of the sample by any means, including by the
				addition of trichomes that were removed during the grinding and homogenization
				process.
(ii) All flower material
				used for potency testing must be representative of the product used by the end
				consumer and homogenized in such a way that it is representative of the way a
				consumer would be using the product. Kief must not be reintroduced to the
				flower sample during the homogenization process, unless fully validated to
				Appendix K of Official Methods of Analysis authored by the Association of
				Official Analytical Collaboration (AOAC) International.
(iii) Potency analysis performed just as the
				marihuana product is without any corrective factor taken for moisture content
				that includes concentrations of the following:
(A) Total tetrahydrocannabinol (THC),
				including reporting all cannabinoids that can be tested for using a method that
				meets the requirements of subrule 2 of this rule.
(B) Tetrahydrocannabinoic acid
				(THC-A).
(C) Total cannabidiol
				(CBD) including reporting all cannabinoids that can be tested for using a
				method that meets the requirements of subrule 2 of this rule.
(D) Cannabidiolic acid (CBD-A).
(E) Additional cannabinoids, which may be
				tested with approval from the agency.