Mich. Admin. Code 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.
Notes
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