On Friday, January 20, 2023, the Division of Cannabis Regulations released the Emergency and Proposed Rules in preparation for recreational sales.
While the majority of the industry was focusing on the changes to Security, Packaging, or those directly related to their licensed facility, many overlooked changes related to Testing Facilities. Most of the changes only affect how Testing Facilities operate internally, but there are a few that directly impact other operators and patients in the industry.
GCA Labs, the first Cannabis Testing Facility to be ISO 17025 Certified in Missouri, did a detailed review of these changes. Jonathan Brace, COO of GCA Labs provided the DCR with a 6 page document outlining suggestions and recommendations to the Testing Facility Rules during the feedback period.
The finalized guidance provided by the department stated that there are no changes between the current rules governing the program and the Emergency Rules. However, there will be a few key changes between the current/emergency rules and the new Proposed Rules.
“The emergency rules and proposed rules are identical, with two exceptions. First, the Department has temporarily retained all of the existing rule requirements that were previously included in 19 CSR 30-95.070 for testing marijuana product. These provisions can now be found in emergency rule 19 CSR 100-1.110. In contrast, the proposed rule 19 CSR 100-1.110, which will go through the formal rulemaking process, contains new requirements that are roughly the same as those in the draft recently posted on our website.”
Below, Brace has outlined a few of the changes in the Proposed Rules and has explained how they affect the testing process. If unmodified, these rules would become effective in August, but many facilities will want to start making process and procedure changes in the next few weeks in order to prepare.
Testing licensees must use published, peer-reviewed testing methods that have been validated for cannabis testing, except those for the cannabinoid profile, and—
1. Report to the department what method will be used prior to using that method;
2. Submit lab method verification to the department prior to offering the applicable testing to other licensed facilities
With this new rule, there will be added time needed for lab facilities to validate testing methods on products they have never tested before. Due to this, manufacturers will want to start working with a Testing Facility early in the process of developing new, innovative products. Testing procedures can vary depending on the product being tested, therefore, in order to streamline the process and ensure the product gets out to the market as quickly as possible, operators will want to work directly with a testing laboratory as soon as possible during the development phase.
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.
This is actually a very positive change for cultivators and manufacturers. With the previous rules, the product has to be tested in its final form, including how it would be packaged and sold to customers. Many groups in the industry have a concentration of THC on their packaging, and not just their compliance label. However, if the product was not correctly dosed or the results were off more than +/-10% the packaging was no longer compliant. With this new rule, it will be easier to remediate products and save time and money on packaging. This rule does not cover vape cartridges, so R&D tests should be done on those products before submitting for a full compliance panel.
The marijuana testing facility shall then homogenize, by grinding or other suitable method, enough of the remaining sample material to run all remaining analyses required plus any extra that may be needed for retesting. If the finished product lot includes such things as stems, seeds, wrap, or leaves, those items must also be included in sample homogenization. Samples must be homogenized to attain an average particle size of less than 1 millimeter.
This rule will mostly affect cultivators, but it will also have direct consequences for any facility making prerolls, which will include dispensaries. One of the main reasons that the THC percentage for flower can be lower, is because of homogenizing stems and fan leaves that were not trimmed properly. Cultivators will want to take an in-depth look at their trimming team, training, and quality control checks. Ensuring the quality standards for flower trimming will help guarantee the best possible results!
A. For dry, unprocessed marijuana, prerolls, infused prerolls, and manually extracted concentrates that are not oil, such as hash and kief, water activity that exceeds 0.65 a w and moisture content below 5.0% or above 15.0%; and
B. For all solid infused products, water activity that exceeds 0.85 a w.
This rule actually changed the moisture content limit to 15.0%. That isn’t a huge change but will help some facilities lower their drying time for flower. The biggest change is actually for manufacturers. Previously there was no mandated water activity test for infused products. In August, water activity will become a mandatory test for most infused products. If a facility has not included an R&D test for water activity on its current test schedule, it may want to consider it. It may be that they need to do a reformulation or process change in order to remain compliant and not have a product fail. Just because the product was compliant and on the market previously does not necessarily mean it will remain compliant when the new rules take effect.
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.
This is a very important rule. If a product fails, the cultivator or manufacturer will only have 15 days to notify the department of what they will do with the product. Then they only have 3 months from failure to complete the tasks. This all falls on the shoulders of the operator to complete this process. Testing labs are unable to report failing results to a facility until after they are uploaded into the state-wide track-and-trace system, so it will be extremely important for the manufacturer or cultivator to act quickly once they are uploaded.
Heavy Metal Failures. Marijuana product that fails mandatory or voluntary testing for heavy metals shall be placed on hold through the statewide track and trace system pending disposal or, if approved by the Department, reanalysis. Product that fails testing for heavy metals may not be remediated.
This new rule may prove difficult for cultivators and anyone that manufactures prerolls. While indoor cultivation has fewer contaminants, outdoor cultivation may be susceptible to heavy metals in the soil.
Anyone that makes prerolls has probably experienced a few issues with heavy metals in the paper. Not all paper manufacturers require chromium to be tested and it can often be found in inks. In this instance, it will be important to use a vendor that tests for the necessary heavy metals, and/or send an R&D test on the papers to a testing laboratory to ensure the end product doesn’t fail.
When talking about heavy metals, another important thing to monitor will be grinding and processing equipment and ensuring strong quality control checks throughout the process. Stainless steel contains Chromium and any small scrapes or metal shavings from grinding can cause cross-contamination into the product. Many groups have switched to glass, ceramic, or in some cases, plastic tools in order to prevent contamination.
Samples from third parties must be delivered by the third parties to the testing facility.
This rule will be very specific for patients and recreational cultivators. For any non-licensed facility to have products tested, they will need to deliver the product to the testing facility. With only a handful of testing facilities across the state, a patient, caregiver, or cultivator may have to travel some distance in order to get their product tested.
Overall, these new proposed rules will help to ensure product quality and end-user safety. Knowing about them ahead of time will allow cultivators and manufacturers the time to prepare and adjust their current processes to be in compliance. If you have any questions about these new proposed rules, contact your lab for more information.
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