MED Rule Changes Effective January 1, 2022
The new rule changes published by the MED will go into effect on the first of the year. Below we’ve outlined some important changes that are coming to testing:
Pre-Rolled Marijuana and Infused Pre-Rolled Marijuana
The new version of the regulations addresses the specific testing requirements for all pre-rolled and infused pre-rolled marijuana products, including required test batch sizes, which tests need to be performed, and process validation. Nordic’s updated Sample Submission Requirements, include both the state’s new minimum test batch sizes as well as our labs’ requirements to perform each test.
Changes to Heavy Metals (Now Referred to as Elemental Impurities)
Beginning in the new year, failed elemental impurities tests can be remediated at a MIP facility that is in compliance with the state’s regulations for elemental impurities remediation. After remediation, two samples will be required to be tested from the Remediated Production Batch. We strongly encourage any licensee that is interested in having their products remediated or would like to offer remediation services to read through the rules to learn more about the specific requirements that go along with remediation.
In addition, if an elemental impurities test is failing on the initial compliance test, the retests must be performed on the original package that was submitted for testing, and licensees will no longer be able to submit new samples for retesting. This process is similar to the failed pesticide testing procedure that is currently in place.
Vapor Emissions Testing
Although Vapor Emissions Testing for elemental impurities officially goes onto the books on January 1, 2022, there are currently no labs certified to perform this test. As such, we do not expect this testing mandate to go into effect right away. Nordic is actively working to validate our emissions testing service. Keep an eye out for additional updates from our team in the near future!
Aspergillus Testing
Beginning on July 1, 2022, the full microbial panel will be expanded to include the speciation of four Aspergillus species. These species include A. fumigatus, A. flavus, A. niger, and A. terreus. Any presence of one of the four Aspergillus species will lead to a failing microbial result. Decontamination and remediation will be permitted for Aspergillus failures. Nordic will be offering Aspergillus testing within the next few months. We will be sure to keep you updated!
Process Validation will be referred to as Reduced Testing Allowance
The new regulations have renamed what we all know as “process validation” to “reduced testing allowance,” or RTA. There are no major changes to obtaining and maintaining a reduced testing allowance at this time.
Changes to Potency Testing
Beginning on July 1, 2022, the standard required potency test will include the addition of Delta-8 THC, Delta-10 THC and Exo-THC. These new THC cannabinoids will need to be included in the total THC potency claim for labeling. Please be aware – this rule change does not permit the manufacturing of these cannabinoids. We strongly encourage our clients to consult with their legal team and read through the new regulations pertaining to these synthesized cannabinoids.
Contact our Denver or Pueblo lab if you have any additional questions about the new rule changes. For more regulatory related documents, check out our new Compliance Resources page on our website.