Mich. Admin. Code R. 420.305

Current through Vol. 24-07, May 1, 2024

Section R. 420.305 - Testing; laboratory requirements

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.

(b) Inspection for foreign matter including powdery mildew, organic, and inorganic material.

(c) Microbial screening including an optimized incubation period for all non-molecular automated systems methods and all plating-based methods used to report quantitative total yeast and mold results.

(d) Chemical residue testing performed for the list of banned chemical residues and the required LOQs published by the agency.

(e) Heavy metals testing as required in this rule.

(f) Residual solvents for production batches of marihuana infused products and edible marihuana products. The agency shall publish a list of required residual solvents to be tested for and their action limits.

(g) Water activity.

(h) Mycotoxin screening if requested by the agency.

(i) Target analytes if requested by the agency. The agency shall publish a list of required target analytes to be tested for and their LOQs.

(4) All marihuana producers may become certified to GMP by a body accredited under ISO 17065. This accreditation may enable the licensee certain allowances with testing. The agency will publish those allowances and information on how to obtain approval for allowances. The standard used for certification for GMP must be American National Standards Institute (ANSI) accredited or equivalent.

(5) All marihuana cultivators may become certified to GACP-GMP by a body accredited under ISO 17065. This accreditation may enable the licensee certain allowances with testing. The agency will publish these allowances and information on how to obtain approval for allowances. The standard used for certification for GACP-GMP must be World Health Organization and American Herbal Products Association or equivalent.

(6) Except as otherwise provided in R 420.306, if a sample collected pursuant to R 420.30 or provided to a laboratory pursuant to these rules does not pass the required safety tests, the marihuana business that provided the sample shall destroy the entire batch from which the sample was taken and document the destruction of the sample using the statewide monitoring system pursuant to the acts and these rules within 90 calendar days.

(7) A laboratory shall conduct residual solvent testing on batches of marihuana concentrates and marihuana-infused products. The agency shall publish a list of required residual solvents to be tested for and their action limits.

(8) A laboratory shall maintain any marihuana samples for at least 30 calendar days after test completion and destroy the resulting waste in accordance with R 420.209.

(9) Potency shall include the following cannabinoid concentrations listed in subdivisions (a) to (f) of this subrule, subject to subdivisions (g) and (h) of this subrule:

(a) Total THC concentration.

(b) THC-A concentration.

(c) The following calculation must be used for calculating Total THC, where [SIGMA] is the sum and M is the mass or mass fraction of each THC isomer being reported or THC-A:

M [SIGMA] THC + (0.877 x M [SIGMA] THC-A) =Total THC

(d) Total CBD concentration.

(e) CBD-A concentration.

(f) Total CBD. The following calculation must be used for calculating Total CBD, where M is the mass or mass fraction of CBD and CBD-A:

M total CBD = M CBD + 0.877 x M CBD-A.

(g) For marihuana and marihuana concentrates, total THC and total CBD must be reported in percentages.

(h) For marihuana infused products, potency must be reported as milligrams of Total THC and Total CBD per gram.

(10) The agency shall publish a list of action limits for the required safety tests in subrule (3) of this rule, except for potency. A marihuana sample with a value that exceeds the published action limit is a failed sample. A marihuana sample that is at or below the action limit is a passing sample.

(11) For chemical residue and target analyte testing, the agency shall publish a list of quantification levels. Any result that exceeds the action limit is a failed sample.

(12) If a sample provided to a laboratory pursuant to this rule and R 420.304 passes the safety tests required under subrule (3) of this rule, the laboratory shall enter the information in the statewide monitoring system of passed test results within 3 business days of test completion. Passed test results must be in the statewide monitoring system for a batch to be released for immediate processing, packaging, and labeling for transfer or sale in accordance with the acts and these rules.

(13) A laboratory shall enter the results into the statewide monitoring system and file with the agency within 3 business days of test completion.

(14) All laboratories shall participate in the proficiency testing program established by the agency. A laboratory shall analyze proficiency test samples from any ISO 17043 accredited vendor on an annual basis unless the agency requests additional testing. The proficiency testing provider shall be accredited for all relevant tests required by the agency and by an accreditation body recognized under the International Laboratory Accreditation Cooperation (ILAC). All testing must use the same procedures with the same number of replicates, standards, testing analysts, and equipment as used for marihuana product testing. A laboratory shall successfully analyze 1 set of proficiency testing samples for all required analytes not less than annually. A laboratory shall have all proficiency testing results submitted directly to the agency from the vendor for review. All failed proficiency tests must include corrective action documentation and must be repeated until the laboratory obtains an acceptable result for all analytes proficiency test. Proficiency tests must be externally graded and results must be reported numerically and not as pass or fail results for all quantitative methods.

(15) The agency shall take immediate disciplinary action against any laboratory that falsifies records or does not comply with the provisions of this rule, including sanctions or fines, or both.

(16) A laboratory shall not do any of the following:

(a) Desiccate samples.

(b) Pre-test samples.

(c) Select the best or most desirable material from a batch for testing. All sample increments must have the same chances of being selected.

(d) Manipulate samples in any way that would alter the sample integrity or homogeneity of the sample.

(17) A laboratory shall comply with random compliance checks at the request of the agency. The agency or its authorized agents may collect a random sample of a marihuana product from a laboratory or designate another laboratory to collect a random sample of a marihuana product in a secure manner to test that sample for compliance pursuant to these rules.

(18) A laboratory may perform terpene analysis on a marihuana product by a method approved by the agency, and the method must be accredited on the same frequency as all required safety tests.

(19) A laboratory shall comply with investigations to ensure the health and safety of the public. At the request of the agency, a laboratory may be requested to perform testing as part of an investigation.

(20) The agency may request mycotoxin testing. A marihuana sample with a value that exceeds the published acceptable level is a failed sample. A marihuana sample that is below the acceptable value is a passing sample.

(21) Marihuana-infused products found to contain Salmonella spp. or Shiga toxin producing E. coli (STEC) must be reported to the agency, in a separate written communication, at the same time as the safety compliance test results are entered into the statewide monitoring system.

Mich. Admin. Code R. 420.305

2020 AACS; 2022 MR 5, Eff. 3/7/2022