PURPOSE: Under Article XIV, Sections 1 and 2 of the Missouri Constitution, the Department of Health and Senior Services has the authority to regulate and control marijuana facilities and to ensure the safe use of marijuana product. This rule explains what regulations apply to the testing of marijuana product.

1. (1) Marijuana testing, generally.

   1. (A) Testing licensees shall test all lots of marijuana product produced by medical and marijuana facilities, including prerolls created at dispensary facilities but excluding seeds and plants, before it may be sold for use by a patient or consumer.

2. (2) Marijuana testing facility certifications.

   1. (A) Any licensee originally certified as a medical marijuana testing facility shall be deemed certified to conduct those activities with respect to all marijuana product.
   2. (B) A testing licensee’s authority to engage in the process of testing marijuana product includes the acquisition, testing, certification, and transportation of marijuana product.

3. (3) Testing facility requirements. In addition to this chapter’s other requirements for licensed facilities and licensees, testing licensees shall also comply with the following:

   1. (A) Standards for personnel.

      1. 1. A marijuana testing licensee must employ a laboratory

director with a degree in a natural science, such as biology, chemistry, physics, engineering, or environmental sciences, and at least five (5) years of experience in a regulated laboratory environment or a degree in another applicable field with at least ten (10) years of experience in a regulated laboratory environment.

1. 2. Individuals performing sampling and testing of

marijuana product, or overseeing the sampling and testing of marijuana product, must have at least a bachelor’s degree in a natural science, such as biology, chemistry, physics, engineering, or environmental sciences, or at least two (2) years of applicable experience;

1. (B) Testing licensees shall be accredited by an International Laboratory Accreditation Cooperation recognized accreditation body under International Organization for Standardization (ISO)/International Electrotechnical Commission (IEC) standard 17025.

   1. 1. Testing licensees shall achieve such accreditation within

one (1) year of the date the licensee receives department approval to operate and shall maintain its accreditation as long as the facility holds a certification.

1. 2. The scope of the accreditation shall include all marijuana

product testing required by this rule.

1. 3. Loss of accreditation shall be reported to the department

by the testing licensee within twenty-four (24) hours of the testing licensee receiving notice of the loss.

1. 4. Inspection and audit reports from the accrediting body

shall be submitted to the department by the testing licensee within twenty-four (24) hours of receipt.

1. A. During any periods of time when a licensee no

longer conforms with ISO/IEC 17025, the licensee shall not conduct testing of marijuana product, until approved by the department in writing, and may be subject to a fine of up to one thousand dollars ($1,000) for every day the facility is not in compliance. Upon return to compliance, the licensee shall not resume testing without department approval.

1. B. If a licensee loses ISO/IEC 17025 accreditation, the SENIOR SERVICES

licensee shall not conduct testing of marijuana product and may be subject to a fine of up to one thousand dollars ($1,000) for every day the licensee is not in compliance.

1. 5. If a licensee does not receive ISO/IEC 17025 accreditation

within one (1) year of the date the licensee receives department approval to operate, the licensee shall not conduct testing of marijuana product and may be subject to a fine of up to one thousand dollars ($1,000) for every day the licensee is not in compliance;

1. (C) After the testing licensee has received approval to operate, the licensee shall participate in an annual proficiency testing program provided by an organization that is accredited to ISO/IEC 17043.

   1. 1. The scope of proficiency testing shall include all

marijuana testing methods performed at the facility for testing required by this rule.

1. 2. The licensee shall notify the department of the

proficiency testing provider the facility chooses prior to engaging with the provider in proficiency testing.

1. 3. The licensee shall analyze proficiency test samples

using the same procedures, number of replicates, standards, and equipment as used for testing marijuana product for each individual conducting those tests at the time.

1. 4. The licensee shall submit copies of proficiency test

results to the department within two (2) business days of receipt.

1. 5. The licensee shall take, and report to the department,

corrective action on all failed proficiency tests, and failed tests must be repeated until the licensee obtains an acceptable result for all analytes. If the licensee fails a proficiency test more than once, the department may require the licensee to suspend mandatory testing of the failed analyte(s) until an acceptable result is received;

1. (D) Testing licensees shall retain all remaining sample material that was not used in the testing process for a minimum of thirty (30) days after testing is complete.

   1. 1. Excess sample material shall be securely stored in a

manner that mitigates sample degradation, contamination, and tampering, and the sample material must be made available to the department upon request.

1. 2. When no longer subject to retention, sample material

shall be disposed pursuant to the waste disposal requirements of this chapter;

1. (E) Testing licensees shall participate in inter-lab comparison efforts as follows:

   1. 1. Licensees must provide marijuana product from

remaining sample material up to twice a year, at the direction of the department, to other licensed facilities for testing;

1. 2. Facilities must receive remaining sample material up to

ten (10) times a year, at the direction of the department, from other licensed facilities for testing;

1. 3. The licensee receiving the marijuana product for

testing will perform the sampling and be responsible for the transportation of the marijuana product, at the direction of the department; and

1. 4. The department may use the inter-lab comparisons to

initiate an investigation or other corrective action for a testing licensee producing inconsistent or anomalous testing results;

1. (F) Testing licensees shall maintain all sampling and testing records for at least five (5) years; and
2. (G) Testing licensees must perform all testing using sampling, methods, and equipment that are appropriate for the tests performed, capable of producing data in a format that meets scientific and regulatory standards, and also permitted within the scope of the licensee’s accreditation under ISO/IEC 17025.

1. (4) Testing methods. SENIOR SERVICES

   1. (A) Testing licensees shall use analytical and microbial testing methodologies that—
   2. (B) 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

analytes are shown to have passed.

1. 2. Validation protocols shall include all marijuana matrices

tested, such as flower, infused products, and/or concentrates. If the initial verification was not performed on a marijuana matrix, a verification shall be performed for each matrix to be tested.

1. 3. Validation protocols for microbiological methods shall

include inoculation of marijuana matrices with live organisms where feasible to ensure that both extraction and detection for the assay are assessed. To further assess the accuracy of the assay, probability of detection analyses, inclusivity, exclusivity, lot-to-lot stability, and robustness studies must be included.

1. 4. Validation of analytical chemistry methods must, where

feasible, verify accuracy, precision, analytical selectivity, limit of detection, limit of quantitation, and reportable range.

1. 5. Validation involving microbiological methods must,

where feasible, address accuracy, limit of detection, and reportable range.

1. (D) Testing licensees may acquire from cultivation, manufacturing, and dispensary facilities raw material, such as plant material, concentrates, extracts, and infused products, for testing method development.

1. (5) Sampling requirements for mandatory testing.

   1. (A) Sampling of marijuana product for mandatory testing shall be done by the testing licensee at the harvest lot or process lot level. All samples must be collected, stored, and transported in a way that mitigates contamination and degradation.

   2. (B) Sampling of each harvest lot or process lot shall be conducted with representative samples such that there is assurance that all harvest or process lots are adequately assessed for contaminants and that the cannabinoid profile is consistent throughout.

      1. 1. In the case of dry, unprocessed marijuana, the maximum

amount of marijuana from which a sample may be selected is fifteen pounds (15 lbs.), and a minimum of five tenths of a percent (0.5%) of a harvest lot will be sampled for testing.

1. 2. In the case of extracts, concentrates, distillates, or

isolates the amount of material required for sampling is— CANNABIS REGULATION

Process Lot Weight Sample

Process Lot Weight Sample Required

6.01-10.00 2.73-4.58 20 10+ 4.58+ 32 10+ 4.58+ 32 3. In the case of vape cartridges, prerolls, infused prerolls

and all other infused products or items sold in a method of administration, the amount of material required for sampling

3,201 – 35,000+ 20

3,201 – 35,000+ 20

1. 4. Where marijuana will be sold in a method of

administration, the marijuana product must be sampled after it has been processed into its method of administration. All other marijuana products may be sampled in bulk after all processing of the harvest lot or process lot is complete.

1. (C) A testing licensee shall not do any of the following:

   1. 1. Desiccate samples;
   2. 2. Pre-test samples;
   3. 3. Select the best or most desirable material from a lot or

sample for testing; or

1. 4. Manipulate samples in any way that would alter the

sample integrity or homogeneity of the sample. All sample increments must have the same chances of being selected; sampling must be random.

1. (6) Mandatory sample ordering and chain of custody.

   1. (A) Testing licensees shall collect samples of a marijuana product from other licensees for mandatory testing, and no licensee may interfere with, assist with, or otherwise participate in the physical collection of a representative sample by a testing licensee.
   2. (B) At the time of sampling for mandatory testing, the cultivation, manufacturing, or dispensary licensee must make the entire harvest or process lot available to the testing licensee for sample collection.
   3. (C) An employee of the cultivation, manufacturing, or dispensary licensee shall be physically present to observe the sampling process and to ensure representative samples are taken from throughout the lot.
   4. (D) Sampling of the lot shall take place in a designated sample area within the cultivation, manufacturing, or dispensary licensee’s facility.

   5. (E) Cultivation, manufacturing, and dispensary licensees will collaborate with testing licensees to create a chain of custody record that includes at least the following information:

      1. 1. The sending facility’s license number;
      2. 2. The legal name, address, and contact information of the

licensee sending the marijuana product for testing;

CANNABIS REGULATION

1. 3. The testing facility’s license number;
2. 4. The legal name, address, and contact information of the

testing licensee;

1. 5. For each lot to be sampled—

   1. A. The marijuana product category;
   2. B. The marijuana product tag number;
   3. C. Total mass of the harvest or process lot;
   4. D. For infused products, the number of units for sale in

the marijuana process lot;

1. E. The marijuana product sample tag number;
2. F. Total mass of the marijuana harvest or process lot

sample;

1. G. For infused products, the number of units sampled of

the marijuana process lot;

1. H. Identification of the test or tests requested;
2. I. Whether the test or tests requested are for mandatory

testing or for voluntary testing;

1. J. Whether a lot is being re-sampled because of a failed

mandatory test;

1. K. Whether the marijuana product was remediated; and
2. L. The date, name, and signature of both the requesting

facility’s representative who was present for sampling and the testing facility’s representative who conducted the sampling.

1. (F) Chain of custody records must be retained by both the requesting licensee and the testing licensee for at least five (5) years.

2. (G) For mandatory testing, it is the responsibility of the cultivation, manufacturing, or dispensary licensee to—

   1. 1. Order the tests necessary to comply with all applicable

rules;

1. 2. Ensure processing of the lot is complete prior to

sampling;

1. 3. Ensure the lot size from which a sample is taken meets

the requirements of this chapter;

1. 4. Only order a test for marijuana product produced by the

licensee;

1. 5. Not order more than one (1) test for the same marijuana

product lot without written approval from the department;

1. 6. Ensure the marijuana product is not on administrative

hold and not awaiting approval for retesting; and

1. 7. Ensure remediation of the marijuana product was

approved by the department.

1. (H) Violation of sampling requirements or manipulation of samples may result in fines up to one hundred thousand dollars ($100,000) and suspension or revocation of license.
2. (I) If a licensee is permitted under this rule to transfer a lot that has failed testing, the licensee must notify the licensee to whom the lot is sold or transferred of the failed test.
3. (J) Once a marijuana product has passed mandatory testing, the marijuana product shall not be repackaged into a new lot in the state-wide track and trace system.
4. (K) Once marijuana product has passed mandatory testing, a copy of the certificate of analysis for mandatory testing shall be provided to all licensees receiving the lot. Copies of the certificate of analysis may be provided electronically.

1. (7) Mandatory testing requirements.

   1. (A) Testing of each harvest lot or process lot shall be conducted such that there is assurance that all harvest or process lots are adequately assessed for contaminants and that the cannabinoid profile is consistent throughout.

   2. (B) Reporting results.

      1. 1. Within ten (10) days of collecting a sample and within

twenty-four (24) hours of completing analysis of a sample, the testing licensee shall file a report in the state-wide track and trace system detailing, at a minimum:

1. A. All test results showing whether the lot passed or SENIOR SERVICES

failed each required test;

1. B. The certificate of analysis provided to the licensee or

third party; and

1. C. A photo of the sample received at the facility.
2. 2. Testing licensees must notify the department if

the timeframe for reporting results will not be met due to an equipment failure. The notification must include an explanation of the equipment failure and the estimated timeframe for the report to be filed in the state-wide track and trace system. The notification must be made prior to deadline for reporting results.

1. (C) Reporting of test results in the state-wide track and trace system must coincide with or precede any notice of test results to the originating facility.
2. (D) Harvest and process lots that have passed mandatory testing may not be retested for purposes of replacing mandatory testing results without written approval from the department.

3. (E) Testing of the cannabinoid profile of the final marijuana product shall include those analytes listed below and shall be reported on a dry weight basis for dried, unprocessed marijuana and prerolls and on an “as is” basis for all other marijuana product. The acceptable limits for each analyte will be a percentage deviation from the mean, using at least three (3) samples, in concentration throughout the lot of fifteen percent (15%) or less:

   1. 1. Delta-9-tetrahydrocannabinol (Δ9-THC), CAS number

1972-08-3;

1. 2. Delta-9-tetrahydrocannabinolic acid (Δ9-THCA), CAS

number 23978-85-0;

1. 3. Cannabidiol (CBD), CAS number 13956-29-1;
2. 4. Cannabidiolic acid (CBDA), CAS number 1244-58-2;
3. 5. Cannabinol (CBN), CAS number 521-35-7;
4. 6. Tetrahydrocannabivarin (THCV), CAS number 31262-37-0;
5. 7. Cannabidivarin (CBDV), CAS number 24274-48-4; and
6. 8. Delta-8-tetrahydrocannabinol (Δ8-THC), CAS number

5957-75-5.

1. (F) The testing licensee shall ensure that any samples for mandatory testing of marijuana are prepared in accordance with the following requirements:

   1. 1. The testing licensee shall first remove any sample

increments required to conduct testing for microbials and water activity;

1. 2. If the final marijuana product includes such things

as stems, seeds, wrap, or leaves, those items must also be included in the sample, but if the final marijuana product will not include such things as stems, seeds, wrap, or leaves, those items must be removed from the product lot prior to sampling;

1. 3. A wrap, crutch, or filter, if present, shall be removed for

cannabinoid profile screening; and

1. 4. In the preparation of samples intended for potency

analysis, the laboratory may not adulterate or attempt to manipulate the potency of the sample.

1. (G) Testing for contaminants in the final marijuana product shall include, but shall not be limited to—

   1. 1. Microbial screening. A test will fail if it shows—

      1. A. A total mycotoxin concentration, including aflatoxins

and ochratoxin A, of greater than twenty (20) micrograms per kilogram;

1. B. Pathogenic E. coli or salmonella concentrations

detectable in one (1) gram; and

1. C. Pathogenic Aspergillus species A. fumigatus, A. flavus,

1. A. niger, or A. terreus detectable in one (1) gram;

   1. 2. Chemical residue screening. A test will fail if it shows— SENIOR SERVICES

      Chemical Abstract

   Permethrins* Prallethrin Phosmet Piperonyl_butoxide Propiconazole Propoxur Pyridaben Pyrethrins+ Spinosad Spiromesifen Spirotetramat Spiroxamine Tebuconazole Thiacloprid Thiamethoxam Trifloxystrobin Vitamin E acetate** * Permethrins cumulative residue of cisand trans-permethrin isomers + Pyrethrins cumulative residues of pyrethrin 1, cinerin 1 and jasmolin 1 **Only for inhalables and concentrates.

   Metal Failure Level for Marijuana (Meant for Inhalation) (ppm)

   Total Arsenic Cadmium Total Chromium Lead Mercury 52645-53-1 23031-36-9 732-11-6 51-03-6 60207-90-1 114-26-1 96489-71-3 8003-34-7 168316-95-8 283594-90-1 203313-25-1 118134-30-8 80443-41-0 111988-49-9 153719-23-4 141517-21-7 58-95-7

   Failure Level for Marijuana-Infused Products (ppm)

> 0.2 > 0.2 > 0.6 > 0.5 > 0.1 > 0.2 > 0.2 > 0.2 > 2 > 0.4 > 0.2 > 0.2 > 1 > 0.2 > 0.2 > 0.2 > 0.4 > 0.4 > 0.2 > 0.2 > 0.2 > 0.2

> 1.5 > 0.5 > 2.0 > 0.5 > 3.0 Methomyl Methomyl Methyl parathion Methyl parathion DIVISION 100—DIVISION OF CANNABIS REGULATION MGK-264 MGK-264 Myclobutanil Myclobutanil Naled Naled Chemical Abstract Oxamyl Oxamyl 16752-77-5 16752-77-5 298-00-0 298-00-0 113-48-4 113-48-4 88671-89-0 88671-89-0 300-76-5 300-76-5 23135-22-0 23135-22-0 > 0.4 > 0.4 > 0.2 > 0.2 > 0.2 > 0.2 > 0.2 > 0.2 > 0.5 > 0.5 > 1 > 1

CANNABIS REGULATION

Chemical Failure Level

Abstract Services for Marijuana (CAS) Registry (Inhalation)

Solvent number

1,2-Dichloroethane 107-06-2

Total Xylenes (ortho-, meta-, para-) 1330-20-7

1. 5. Water activity and moisture content screening. A test

will fail if it shows—

1. A. For dry, unprocessed marijuana, prerolls, and infused

prerolls, water activity that exceeds 0.65 a w and moisture content below 5.0% or above 15.0%;

1. B. For manually extracted concentrates that are not oil,

such as hash and kief, water activity that exceeds 0.65 a w; and

1. C. For all solid infused products, water activity that

exceeds 0.85 a w.

1. 6. Foreign matter screening. Testing shall be performed on

the total representative sample after preparation for microbial and water activity testing and prior to preparation for all other testing.

1. A. Quantitation of foreign matter shall be measured

using a total surface area calculation.

1. B. All evaluation must be done on high power

magnification.

1. C. Examine both the exterior and interior of the sample.
2. D. Must use a grading scale determine by the testing

licensees which clearly dictates a failed sample.

1. E. A test will fail if it shows—

   1. (I) More than 5.0% of stems 3 mm or more in diameter;

or

1. (II) More than 2.0% of other foreign matter (powdery

1. (ppm) > 2

> 150

mildew, mold, mites, hair, dirt, etc.).

1. (8) Testing licensees may perform terpene analysis on a sample submitted for mandatory testing for purposes of reporting results on marijuana product packaging. Testing licensees who offer terpene analysis for mandatory samples must include terpene analysis in the scope of accreditation and scope of proficiency testing.
2. (9) Voluntary testing.

dispensary licensee, testing licensees may also test material that was not collected by the testing licensee according to the rules for mandatory test sampling. Results from such voluntary tests will not satisfy mandatory testing requirements.

agreeable to the submitting facility, but all test results from voluntary testing must be reported in the state-wide track and trace system.

system must coincide with or precede any notice of test results to the originating facility.

1. (10) Testing failures. SENIOR SERVICES

Failure Level for Marijuana- Infused Products (ppm) > 5

> 2170

1. (A) Upon request from a cultivation, manufacturing, or
2. (B) Voluntary testing may be completed on a schedule
3. (C) Reporting of test results in the state-wide track and trace

SENIOR SERVICES

1. (A) The department will place an administrative hold on marijuana product that fails mandatory testing through the state-wide track and trace system.

2. (B) All product that fails mandatory testing must be reanalyzed, remediated, or destroyed within three (3) months of initial test failure. Product that fails mandatory testing may be reanalyzed, remediated, or destroyed as follows:

   1. 1. Before taking action with any product that fails

mandatory testing, licensees must, within fifteen (15) days of test failure, notify the department of their intent to proceed in one of the following ways:

1. A. Reanalysis of previously tested sample;
2. B. Remediation of the harvest or process lot through

remediation actions specifically allowed by rule;

1. C. Destruction of the harvest or process lot; or
2. D. Submission of a request to perform remediation not

specifically allowed by rule;

1. 2. After notifying the department, licensees may—

   1. A. Reanalyze the original sample collected for testing.

      1. (I) Reanalysis may be performed by the testing facility

that performed the initial analysis or a testing facility that did not perform the initial analysis.

1. (II) If the sample passes reanalysis, a testing facility

that did not perform the initial analysis or reanalysis may sample the lot and perform testing on that new sample in compliance with all rules for mandatory testing;

1. B. Complete marijuana product remediation through

a remediation process specifically allowed by this rule. After a product has been remediated, the testing facility that performed the initial analysis or a testing facility that did not perform the initial analysis shall resample the lot and perform testing on that new sample in compliance with all rules for mandatory testing;

1. C. Destroy the product; or
2. D. Submit a request to remediate the product through

a method not specifically approved by this rule. Such requests must be approved by the department, in writing, prior to the licensee taking any remediation actions.

1. (C) Heavy Metal Failures. Marijuana product that fails mandatory testing for heavy metals shall be placed on administrative hold through the state-wide track and trace system pending disposal or, if approved by the department, reanalysis. Product that fails testing for heavy metals may not be remediated.

1. (11) Approved remediation processes. Marijuana product that fails testing, except for heavy metal failure, may be remediated. After notifying the department of intent to remediate, licensees may conduct the following remediation processes without additional approval:

   1. (A) Failed microbial screening may be remediated through solvent-based extraction or processing, such as hydrocarbon, ethanol, or carbon dioxide;
   2. (B) Failed residual solvent testing may be remediated by returning the product to a purging process within the facility;

   3. (C) Failed water activity testing may be remediated by—

      1. 1. Solvent-based extraction or processing; or
      2. 2. Additional drying or curing;
   4. (D) Failed chemical residue screening may be remediated through solvent-based extraction or processing, such as hydrocarbon, ethanol, or CO2;
   5. (E) A lot that fails reanalysis may not be reanalyzed again but may be remediated one (1) time; and
   6. (F) A lot that fails remediation may not be remediated again but may be reanalyzed one (1) time. CANNABIS REGULATION

2. (12) A medical or marijuana licensee may be required by the department to submit samples of marijuana product for testing at any time and without notice.

   1. (A) The department may have the marijuana product tested at a marijuana testing facility, the Missouri State Public Health Laboratory, or any other lab authorized to conduct the required tests. If the department requests that a marijuana testing facility test the marijuana product, the facility may not charge the department any more than it would ordinarily charge any other entity for whom it performs the same or similar tests.
   2. (B) Samples collected will be tested by the department to determine whether the marijuana product is safe for human consumption and is accurately labeled or to verify the result of marijuana testing conducted by a marijuana testing laboratory.

   3. (C) Samples may be collected either through random process to determine accuracy of testing results or when the department has reasonable grounds to believe—

      1. 1. Marijuana product is contaminated or mislabeled;
      2. 2. A licensee is in violation of any rule, statute, or Article

XIV; or

1. 3. The results of a test would further an investigation by

the department.

1. (13) Testing licensees may test marijuana product and hemp product received from entities that are not licensed marijuana facilities.

   1. (A) Samples for these tests must be delivered by the entity requesting the test to the testing facility.

   2. (B) Prior to engaging in these services, testing licensees must submit standard operating procedures related to these services to the department for review, which must include:

      1. 1. Tagging and tracking;
      2. 2. Chain of custody; and
      3. 3. Testing methods if different from the testing methods

established for testing of marijuana product for medical and marijuana facilities.

AUTHORITY: sections 1.3.(1)(b), 1.3.(2), 2.4(1)(b), and 2.4(4) of Article XIV, Mo. Const. Emergency rule filed Jan. 20, 2023, effective Feb. 3, 2023, expired Aug. 1, 2023. Original rule filed Jan. 20, 2023, effective July 30, 2023.