Missouri Code of State Regulations
Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES
Division 100 - Division of Cannabis Regulation
Chapter 1 - Marijuana
Section 19 CSR 100-1.110 - Testing
Universal Citation: 19 MO Code of State Regs 100-1.110
Current through Register Vol. 49, No. 18, September 16, 2024
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) Marijuana testing, generally.
(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) Marijuana testing facility certifications.
(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.
(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) Testing facility requirements. In addition to this chapter's other requirements for licensed facilities and licensees, testing licensees shall also comply with the following:
(A) Standards for personnel.
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.
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;
(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. 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.
2.
The scope of the accreditation shall include all marijuana product testing
required by this rule.
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.
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.
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.
B. If a licensee loses ISO/IEC 17025
accreditation, 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.
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;
(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. The scope of proficiency testing
shall include all marijuana testing methods performed at the facility for
testing required by this rule.
2.
The licensee shall notify the department of the proficiency testing provider
the facility chooses prior to engaging with the provider in proficiency
testing.
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.
4. The licensee shall submit copies of
proficiency test results to the department within two (2) business days of
receipt.
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;
(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. 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.
2. When no longer
subject to retention, sample material shall be disposed pursuant to the waste
disposal requirements of this chapter;
(E) Testing licensees shall participate in
inter-lab comparison efforts as follows:
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;
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;
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
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;
(F) Testing
licensees shall maintain all sampling and testing records for at least five (5)
years; and
(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.
(4) Testing methods.
(A) Testing licensees shall use analytical
and microbial testing methodologies that-
1.
Are based upon published peer-reviewed methods;
2. Have been validated for cannabis testing
by an independent third party; and
3. Have been internally verified by the
testing licensee 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.
(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 cannabis standard method performance requirements,
where available, and if published cannabis standard method performance
requirements are not available, compendia or other reputable sources.
(C) Testing licensees shall report to the
department what testing method will be used prior to using that method and
submit lab method validations to the department prior to offering the
applicable testing to other licensed facilities.
1. Validations must be submitted with an
acceptable and graded external proficiency test by a third party, where all
analytes are shown to have passed.
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.
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.
4. Validation of analytical chemistry methods
must, where feasible, verify accuracy, precision, analytical selectivity, limit
of detection, limit of quantitation, and reportable range.
5. Validation involving microbiological
methods must, where feasible, address accuracy, limit of detection, and
reportable range.
(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.
(5) Sampling requirements for mandatory testing.
(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.
(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. 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.
2.
In the case of extracts, concentrates, distillates, or isolates the amount of
material required for sampling is-
|
Process Lot Weight |
Sample Required (1±0.2 g) |
|
|
Pounds |
Kilograms |
|
|
0-0.50 |
0-0.23 |
4 |
|
0.51-1.5 |
0.24-0.68 |
8 |
|
1.51-3.00 |
0.69-1.36 |
12 |
|
3.01-6.00 |
1.37-2.72 |
16 |
|
6.01-10.00 |
2.73-4.58 |
20 |
|
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 is-
|
Units for Sale |
Representative Sample Units Required |
|
2-15 |
2 |
|
16-50 |
3 |
|
51-150 |
5 |
|
151-500 |
8 |
|
501-3,200 |
13 |
|
3,201 - 35,000+ |
20 |
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.
(C) A testing licensee shall not do any of
the following:
1. Desiccate
samples;
2. Pre-test
samples;
3. Select the best or most
desirable material from a lot or sample for testing; or
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.
(6) Mandatory sample ordering and chain of custody.
(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.
(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.
(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.
(D)
Sampling of the lot shall take place in a designated sample area within the
cultivation, manufacturing, or dispensary licensee's facility.
(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. The sending facility's license
number;
2. The legal name, address,
and contact information of the licensee sending the marijuana product for
testing;
3. The testing facility's
license number;
4. The legal name,
address, and contact information of the testing licensee;
5. For each lot to be sampled-
A. The marijuana product category;
B. The marijuana product tag
number;
C. Total mass of the
harvest or process lot;
D. For
infused products, the number of units for sale in the marijuana process
lot;
E. The marijuana product
sample tag number;
F. Total mass of
the marijuana harvest or process lot sample;
G. For infused products, the number of units
sampled of the marijuana process lot;
H. Identification of the test or tests
requested;
I. Whether the test or
tests requested are for mandatory testing or for voluntary testing;
J. Whether a lot is being re-sampled because
of a failed mandatory test;
K.
Whether the marijuana product was remediated; and
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.
(F) Chain of custody
records must be retained by both the requesting licensee and the testing
licensee for at least five (5) years.
(G) For mandatory testing, it is the
responsibility of the cultivation, manufacturing, or dispensary licensee to-
1. Order the tests necessary to comply with
all applicable rules;
2. Ensure
processing of the lot is complete prior to sampling;
3. Ensure the lot size from which a sample is
taken meets the requirements of this chapter;
4. Only order a test for marijuana product
produced by the licensee;
5. Not
order more than one (1) test for the same marijuana product lot without written
approval from the department;
6.
Ensure the marijuana product is not on administrative hold and not awaiting
approval for retesting; and
7.
Ensure remediation of the marijuana product was approved by the
department.
(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.
(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.
(J) Once a marijuana
product has passed mandatory testing, the marijuana product shall not be
repackaged into a new lot in the statewide track and trace system.
(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.
(7) Mandatory testing requirements.
(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.
(B)
Reporting results.
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:
A. All
test results showing whether the lot passed or failed each required
test;
B. The certificate of
analysis provided to the licensee or third party; and
C. A photo of the sample received at the
facility.
2. Testing
licensees must notify the department if the time frame 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 time frame 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.
3. A photo of the sample received at the
facility.
(C) Reporting
of test results in the statewide track and trace system must coincide with or
precede any notice of test results to the originating facility.
(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.
(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. Delta-9-tetrahydrocannabinol
([DELTA]9-THC), CAS number 1972-08-3;
2. Delta-9-tetrahydrocannabinolic acid
([DELTA]9-THCA) CAS number 23978-85-0;
3. Cannabidiol (CBD), CAS number
13956-29-1;
4. Cannabidiolic acid
(CBDA), CAS number 1244-58-2;
5.
Cannabinol (CBN), CAS number 521-35-7;
6. Tetrahydrocannabivarin (THCV), CAS number
31262-370;
7. Cannabidivarin
(CBDV), CAS number 24274-48-4; and
8. Delta-8-tetrahydrocannabinol
([DELTA]8-THC), CAS number 5957-75-5.
(F) The testing licensee shall ensure that
any samples for mandatory testing of marijuana are prepared in accordance with
the following requirements:
1. The testing
licensee shall first remove any sample increments required to conduct testing
for microbials and water activity;
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;
3. A wrap,
crutch, or filter, if present, shall be removed for cannabinoid profile
screening; and
4. In the
preparation of samples intended for potency analysis, the laboratory may not
adulterate or attempt to manipulate the potency of the sample.
(G) Testing for contaminants in
the final marijuana product shall include, but shall not be limited to-
1. Microbial screening. A test will fail if
it shows-
A. A total mycotoxin concentration,
including aflatoxins and ochratoxin A, of greater than twenty (20) micrograms
per kilogram;
B. Pathogenic E. coli
or salmonella concentrations detectable in one (1) gram; and
C. Pathogenic Aspergillus species A.
fumigatus, A. flavus, A. niger, or A. terreus detectable in one (1)
gram;
2. Chemical residue
screening. A test will fail if it shows-
|
Banned Analytes |
Chemical Abstract Services (CAS) Registry number |
Action Limit (ppm) |
|
Abamectin |
71751-41-2 |
> 0.5 |
|
Acephate |
30560-19-1 |
> 0.4 |
|
Acequinocyl |
57960-19-7 |
> 2 |
|
Acetamiprid |
135410-20-7 |
> 0.2 |
|
Aldicarb |
116-06-3 |
> 0.4 |
|
Azoxystrobin |
131860-33-8 |
> 0.2 |
|
Bifenazate |
149877-41-8 |
> 0.2 |
|
Bifenthrin |
82657-04-3 |
> 0.2 |
|
Boscalid |
188425-85-6 |
> 0.4 |
|
Carbaryl |
63-25-2 |
> 0.2 |
|
Carbofuran |
1563-66-2 |
> 0.2 |
|
Chloran-traniliprole |
500008-45-7 |
> 0.2 |
|
Chlorfenapyr |
122453-73-0 |
> 1 |
|
Chlormequat Chloride |
7003-89-6 |
> 0.2 |
|
Chlorpyrifos |
2921-88-2 |
> 0.2 |
|
Clofentezine |
74115-24-5 |
> 0.2 |
|
Cyfluthrin |
68359-37-5 |
> 1 |
|
Cypermethrin |
52315-07-8 |
> 1 |
|
Daminozide |
1596-84-5 |
> 1 |
|
DDVP (Dichlorvos) |
62-73-7 |
> 1 |
|
Diazinon |
333-41-5 |
> 0.2 |
|
Dimethoate |
60-51-5 |
> 0.2 |
|
Ethoprophos |
13194-48-4 |
> 0.2 |
|
Etofenprox |
80844-07-1 |
> 0.4 |
|
Etoxazole |
153233-91-1 |
> 0.2 |
|
Fenoxycarb |
72490-01-8 |
> 0.2 |
|
Fenpyroximate |
134098-61-6 |
> 0.4 |
|
Fipronil |
120068-37-3 |
> 0.4 |
|
Flonicamid |
158062-67-0 |
> 1 |
|
Fludioxonil |
131341-86-1 |
> 0.4 |
|
Hexythiazox |
78587-05-0 |
> 1 |
|
Imazalil |
35554-44-0 |
> 0.2 |
|
Imidacloprid |
138261-41-3 |
> 0.4 |
|
Kresoxim-methyl |
143390-89-0 |
> 0.4 |
|
Malathion |
121-75-5 |
> 0.2 |
|
Metalaxyl |
57837-19-1 |
> 0.2 |
|
Methiocarb |
2032-65-7 |
> 0.2 |
|
Methomyl |
16752-77-5 |
> 0.4 |
|
Methyl parathion |
298-00-0 |
> 0.2 |
|
MGK-264 |
113-48-4 |
> 0.2 |
|
Myclobutanil |
88671-89-0 |
> 0.2 |
|
Naled |
300-76-5 |
> 0.5 |
|
Oxamyl |
23135-22-0 |
> 1 |
|
Paclobutrazol |
76738-62-0 |
> 0.4 |
|
Permethrins* |
52645-53-1 |
> 0.2 |
|
Prallethrin |
23031-36-9 |
> 0.2 |
|
Phosmet |
732-11-6 |
> 0.2 |
|
Piperonyl_butoxide |
51-03-6 |
> 2 |
|
Propiconazole |
60207-90-1 |
> 0.4 |
|
Propoxur |
114-26-1 |
> 0.2 |
|
Pyridaben |
96489-71-3 |
> 0.2 |
|
Pyrethrins+ |
8003-34-7 |
> 1 |
|
Spinosad |
168316-95-8 |
> 0.2 |
|
Spiromesifen |
283594-90-1 |
> 0.2 |
|
Spirotetramat |
203313-25-1 |
> 0.2 |
|
Spiroxamine |
118134-30-8 |
> 0.4 |
|
Tebuconazole |
80443-41-0 |
> 0.4 |
|
Thiacloprid |
111988-49-9 |
> 0.2 |
|
Thiamethoxam |
153719-23-4 |
> 0.2 |
|
Trifloxystrobin |
141517-21-7 |
> 0.2 |
|
Vitamin E acetate** |
58-95-7 |
> 0.2 |
* Permethrins cumulative residue of cis- and trans-permethrin isomers
+ Pyrethrins cumulative residues of pyrethrin 1, cinerin 1 and jasmolin 1
**Only for inhalables and concentrates.
3. Heavy metal screening. A test will fail if
it shows-
|
Metal |
Failure Level for Marijuana (Meant for Inhalation) (ppm) |
Failure Level for Marijuana-Infused Products (ppm) |
|
Total Arsenic |
> 0.2 |
> 1.5 |
|
Cadmium |
> 0.2 |
> 0.5 |
|
Total Chromium |
> 0.6 |
> 2.0 |
|
Lead |
> 0.5 |
> 0.5 |
|
Mercury |
> 0.1 |
> 3.0 |
4.
Residual solvents. A test will fail if it shows-
|
Solvent |
Chemical Abstract Services (CAS) Registry number |
Failure Level for Marijuana (Inhalation) (ppm) |
Failure Level for Marijuana-Infused Products (ppm) |
|
1,2-Dichloroe-thane |
107-06-2 |
> 2 |
> 5 |
|
Acetone |
67-64-1 |
> 750 |
> 5000 |
|
Acetonitrile |
75-05-8 |
> 60 |
> 410 |
|
Benzene |
71-43-2 |
> 1 |
> 2 |
|
Butanes (all isomers) |
106-97-8 |
> 800 |
> 5000 |
|
Chloroform |
67-66-3 |
> 2 |
> 60 |
|
Ethanol |
64-17-5 |
> 1000 |
> 5000 |
|
Ethyl acetate |
141-78-6 |
> 400 |
> 5000 |
|
Ethyl ether |
60-29-7 |
> 500 |
> 5000 |
|
Ethylene Oxide |
75-21-8 |
> 5 |
> 50 |
|
Heptane |
142-82-5 |
> 500 |
> 5000 |
|
Hexanes (all isomers) |
11054-3 |
> 50 |
> 290 |
|
Isopropyl alcohol |
67-63-0 |
> 500 |
> 5000 |
|
Methanol |
67-56-1 |
> 250 |
> 3000 |
|
Methylene chloride |
75-09-2 |
> 125 |
> 600 |
|
Pentanes (all isomers) |
109-66-0 |
> 750 |
> 5000 |
|
Propane |
74-98-6 |
> 2100 |
> 5000 |
|
Toluene |
108-88-3 |
> 150 |
> 890 |
|
Trichloroethylene |
79-01-6 |
> 25 |
> 80 |
|
Total Xylenes (ortho-, meta, para-) |
1330-20-7 |
> 150 |
> 2170 |
5.
Water activity and moisture content screening. A test will fail if it shows-
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%;
B. For
manually extracted concentrates that are not oil, such as hash and kief, water
activity that exceeds 0.65 a w; and
C. For all solid infused products, water
activity that exceeds 0.85 a w.
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.
A. Quantitation of foreign matter shall be
measured using a total surface area calculation.
B. All evaluation must be done on high power
magnification.
C. Examine both the
exterior and interior of the sample.
D. Must use a grading scale determine by the
testing licensees which clearly dictates a failed sample.
E. A test will fail if it shows-
(I) More than 5.0% of stems 3 mm or more in
diameter; or
(II) More than 2.0% of
other foreign matter (powdery mildew, mold, mites, hair, dirt, etc.).
(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.
(9) Voluntary testing.
(A) Upon request from a cultivation,
manufacturing, or 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.
(B)
Voluntary testing may be completed on a schedule agreeable to the submitting
facility, but all test results from voluntary testing must be reported in the
state-wide track and trace system.
(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.
(10) Testing failures.
(A) The department will place an
administrative hold on marijuana product that fails mandatory testing through
the state-wide track and trace system.
(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. 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:
A.
Reanalysis of previously tested sample;
B. Remediation of the harvest or process lot
through remediation actions specifically allowed by rule;
C. Destruction of the harvest or process lot;
or
D. Submission of a request to
perform remediation not specifically allowed by rule.
2. After notifying the department, licensees
may-
A. Reanalyze the original sample
collected for testing.
(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.
(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;
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;
C.
Destroy the product; or
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.
(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.
(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:
(A) Failed microbial screening may be
remediated through solvent-based extraction or processing, such as hydrocarbon,
ethanol, or carbon dioxide;
(B)
Failed residual solvent testing may be remediated by returning the product to a
purging process within the facility;
(C) Failed water activity testing may be
remediated by-
1. Solvent-based extraction or
processing; or
2. Additional drying
or curing;
(D) Failed
chemical residue screening may be remediated through solvent-based extraction
or processing, such as hydrocarbon, ethanol or
CO2;
(E) A
lot that fails reanalysis may not be reanalyzed again but may be remediated one
time; and
(F) A lot that fails
remediation may not be remediated again but may be reanalyzed one (1)
time.
(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.
(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.
(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.
(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.
Marijuana product is contaminated or mislabeled;
2. A licensee is in violation of any rule,
statute, or Article XIV; or
3. The
results of a test would further an investigation by the department.
(13) Testing licensees may test marijuana product and hemp product received from entities that are not licensed marijuana facilities.
(A) Samples
for these tests must be delivered by the entity requesting the test to the
testing facility.
(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. Tagging and tracking;
2. Chain of custody; and
3. Testing methods if different from the
testing methods established for testing of marijuana product for medical and
marijuana facilities.
Disclaimer: These regulations may not be the most recent version. Missouri may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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