Rule 31. Testing; safety compliance facility.

(1) A safety compliance facility shall use analytical testing methodologies for the required quality assurance tests in subrule (2) of this rule that are validated and may be monitored on an ongoing basis by the department or a third party which shall include either of the following:

(a) Following the most current version of the Cannabis Inflorescence: Standards of Identity, Analysis, and Quality Control monograph published by the American Herbal Pharmacopoeia.

(b) Following the alternative testing methodology approved by the department and validated by an independent third party that the methodology followed by the laboratory produces scientifically accurate results as quality assurance for each test it conducts.

(2) A safety compliance facility shall conduct the required quality assurance tests that include all of the following:

(a) Moisture content.

(b) Potency analysis.

(c) Tetrahydrocannabinol level.

(d) Tetrahydrocannabinol acid level.

(e) Cannabidiol and cannabidiol acid levels.

(f) Foreign matter inspection.

(g) Microbial and mycotoxin screening.

(h) Pesticides.

(i) Chemical residue.

(j) Fungicides.

(k) Insecticides.

(l) Metals screening.

(m) Residual solvents levels.

(n) Terpene analysis.

(o) Water activity content.

(3) Except as otherwise provided, if a sample collected pursuant to Rule 32 or provided to a safety compliance facility pursuant to these rules does not pass the microbial, mycotoxin, heavy metal, pesticide chemical residue, or residual solvents levels test based on these rules, the marihuana facility that provided the sample shall dispose of the entire batch from which the sample was taken and document the disposal of the sample using the statewide monitoring system pursuant to the act, marihuana tracking act, and these rules.

(4) For the purposes of the microbial test, a sample provided to a safety compliance facility pursuant to this rule is deemed to have passed if it satisfies the standards set forth in Table 9 of the Cannabis Inflorescence: Standards of Identity, Analysis, and Quality Control monograph adopted by reference pursuant to these rules.

(5) For the purposes of the mycotoxin test, a sample provided to a safety compliance facility pursuant to this rule is deemed to have passed if it meets the following standards:


 

(6) For the purposes of the heavy metal test, a sample of marihuana is deemed to have passed if it meets the following standards:



The acceptable limit for finished products is calculated using the following equation: X ug/kg x 70 kg x 1/10 g = Y ug/g
 

(7) A safety compliance facility shall do the following:

(a) Become fully accredited to the International Organization for Standardization (ISO), ISO/IEC 17025, by an ISO 17011, ILAC recognized accreditation body or by an entity approved by the department within 1 year after the date the license is issued and agree to have the inspections and reports of the International Organization for Standardization made available to the department.

(b) Become provisionally accredited under subdivision (a) of this subrule within 6 months from the issuance of a license. A safety compliance facility may be ordered to cease operations if provisional accreditation is not received within 6 months.

(c) Maintain internal standard operating procedures.

(d) Maintain a quality control and quality assurance program.

(8) The department shall establish a proficiency testing program and designate safety compliance facility participation. A safety compliance facility shall analyze proficiency test samples using the same procedures with the same number of replicate analyses, standards, testing analysts and equipment as used for marihuana product testing.

(9) The department shall publish a list of approved pesticides for use in the cultivation and production of marihuana plants and marihuana products to be sold or transferred in accordance with the act or these rules. For the purposes of the pesticide chemical residue test, a sample provided to a safety compliance facility pursuant to this rule is deemed to have passed as to that chemical if the sample satisfies the most stringent acceptable standard for an approved pesticide chemical residue as set forth in Subpart C of 40 C.F.R. Part 180, 40 C.F.R., § 180, et seq. or FIFRA section 25(b), whichever is more stringent.

(10) If a sample provided to a safety compliance facility pursuant to this rule and Rule 32 passes the tests required under subrule (2) of this rule, the safety compliance facility shall enter the information in the statewide monitoring system of passed test results. 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 act and these rules.

(11) A safety compliance facility shall enter the results into the statewide monitoring system and file with the department an electronic copy of each safety compliance facility test result for any batch that does not pass the required tests while it transmits those results to the facility that provided the sample. In addition, a safety compliance facility shall maintain the test results and make them available to the department upon request.

(12) The department shall take immediate disciplinary action against any safety compliance facility that fails to comply with the provisions of this rule or falsifies records related to this rule, including any sanctions or fine, or both.

(13) A safety compliance facility is prohibited from doing the following:

(a) Desiccating samples.

(b) Dry labeling samples.

(c) Pre-testing samples.

(14) A safety compliance facility shall comply with random quality assurance compliance checks upon the request of the department. The department or its authorized agents may collect a random sample of marihuana product from a safety compliance facility or designate another safety compliance facility to collect a random sample of marihuana product in a secure manner to test that sample for quality assurance compliance pursuant to this rule.

(15) A safety compliance facility shall comply with the Cannabis Inflorescence: Standards of Identity, Analysis, and Quality Control monograph published by the American Herbal Pharmacopoeia, and any updates, which is adopted by reference as part of these rules, unless these rules provide otherwise.


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