By: Cassidy Neal, Esq.
On January 26, 2021, Maine’s Office of Marijuana Policy (OMP) issued a guidance document for Retesting and Remediation of Marijuana Items Subject to a Failed Test. The guidance below is crucial for businesses to understand their options for mitigating the financial risks associated with products that fail mandatory testing and remediation.
A portion of the guidance document applies to future testing requirements. For example, when OMP implements mandatory testing for residual solvents later in 2021, a licensee may choose to remediate a batch that failed mandatory testing for residual solvents without OMP’s prior approval. When OMP implements mandatory testing for pesticides and other harmful chemicals (metals), licensees cannot remediate a batch that failed mandatory testing for pesticides or metals – but may choose to submit samples for retesting if the licensee believes the failed test was in error.
However, effective immediately, a licensee may remediate (without OMP’s prior approval) a batch or batches of marijuana, marijuana concentrate or marijuana product that fails mandatory testing for filth and foreign material, dangerous molds and mildews, harmful microbes, or water activity or moisture content.
If a batch fails testing for an analyte type that may be remediated, the licensee has four options: (1) retest if the licensees believes the result was in error; (2) remediate the batch in-house and submit for retesting; (3) transfer the failed batch to a products manufacturing facility for remediation and retesting; or (4) destroy the failed batch.
If a batch fails testing for an analyte type that may not be remediated, the licensee has two options: (1) retest if the licensees believes the result was in error; or (2) destroy the failed batch.
Either way, the licensee must record all retesting, remediation, and destruction in METRC within 30 days of receiving the final certificate of analysis from the marijuana testing facility that reported the failed test result. Failure to record any retesting, remediation, destruction within this 30 day window will result in OMP issuing to the licensee a Final Order of Destruction for the entire failed batch.
If a licensees believes the failed test was in error and they want to retest the failed batch, they must submit two separate samples from the failed batch for the retesting. The failed batch would be required to then pass two subsequent tests for the specific analyte categories that originally failed.
OMP’s example: A batch of marijuana concentrate that fails for total yeast and mold would be required to pass two subsequent tests for the required analytes under the category of “dangerous molds and mildew” (including mycotoxin analysis) in order to be transferred to another licensee.
If the failed batch can be remediated, the licensee may remediate the failed batch in-house or send the failed batch to a products manufacturing facility for remediation and retesting. If the failed batch remains in the same form as the initial failed batch, the licensee must submit two separate samples from that failed batch, and then would be required to pass two subsequent tests for specific analyte categories that originally failed.
OMP’s example: A batch of marijuana flower that fails for water activity may be remediated by additional drying and curing and would be required to pass two subsequent tests for water activity and moisture content in order to be transferred to another licensee.
If the failed batch remaining is not in the same form as the initial failed batch, the licensee must submit a single sample from the resulting remediated batch. The remediated batch would then be required to pass one subsequent round of all required tests for items in its form following remediation (including mycotoxin analysis if the original test failed for total yeast and mold). If the remediated batch, in its new form, fails the subsequent test, it is treated as an “original” failed test and the license may begin the retesting or remediation process again.
OMP’s example: A batch of marijuana flower fails for total yeast and mold, is transferred to a manufacturing facility, and is remediated by hydrocarbon extraction into marijuana concentrate. The new marijuana item (concentrate) would need to pass all required tests for marijuana concentrate, as well as mycotoxin analysis, in order to be transferred to another licensee.
Please contact our Licensing and Regulatory Compliance division for more information on OMP’s recent guidance and how to mitigate the risks associated with failed mandatory testing.