By Leslie Engelking, Andrew Samann & Justin Greene

Oregon’s recreational cannabis market experienced its first recall of cannabis this month after cannabis flower containing high levels of pyrethrin was sold to the public. The Oregon Liquor Control Commission (OLCC) issued the first recall of recreational cannabis after BUDS 4 U notified the commission of contaminated cannabis flower. Samples of Blue Magoo failed for the chemical pyrethrin when tested at GreenHaus Analytical Labs. Several breakdowns of the quality system in each tier of the distribution system occurred for this recall to take place.

The root cause of the recall stemmed from the application of pyrethrin. This chemical is a widely-used insecticide for soft-bodied insects and is considered to have low acute toxicity in humans or mammals. The fact it was applied indicates a need to eliminate insects. In no case should a pesticide be applied without cause. If it is necessary to eliminate pests, it is the responsibility of management to minimize the introduction of pesticides that will adequately eliminate the pest and preserve quality of the cannabis.

Insects are foreign bodies that should not be present in cultivation operations when proper quality management systems (QMS) are in place and strictly enforced by all employees of the operation. Proper quarantine and Quality Control (QC) testing of raw materials such as grow mediums or nutrients should eliminate the presence of foreign bodies. Any outside materials introduced to the cultivation room or greenhouse should be quarantined before being used and be required to meet quality assurance specifications that ensure contamination risk is eliminated.

Proper environmental controls ensure that the physical cultivation areas are maintained in a way to eliminate the introduction of pests. Requiring employees to change from personal clothing reduces the probability of inadvertently introducing pests from outside environments. Insect nets on regularly inspected external vents or air circulation systems reduces the chance for introduction of infestation into the cultivation areas. Regular inspection of physical structure for damage or deterioration reduces risks of outside pests being introduced to the operation. The preventative measures listed offer some examples of what can be done to eliminate the introduction of pests into cultivation areas, however sanitization between harvest batches must be performed as a primary preventative measure. This ensures that the room and all equipment will not be the source of contamination.

From a QMS point of view, the most serious breakdown of process is the release of cannabis that was not verified by approval of the operation’s quality assurance department. This harvest lot or batch should have been segregated and properly quarantined until specifications were met. It is the responsibility of quality assurance to certify that all products have met the entirety of the specifications, including pesticide residue, before releasing for shipment. Approval and verification of meeting product specifications before batch release is the most vital duty of any quality assurance department.

Not only was the batch released from the cultivation facility without being properly certified, but the distributor was careless enough to release the product to a dispensary without completing their own quality assurance checks to ensure the products in their control were properly tested and that all specifications were met. The dispensary is also partially to blame, but it should also be praised considering it initiated the notification to the OLCC and started the recall process. If proper checks were in place through the QMS system this would have been caught and the public’s safety would not have been at risk.

QMS only works if every aspect is strictly enforced and followed to the letter. Each operation has the responsibility to verify all specifications and checks are made when the health and safety of the public is at risk. Adherence and certification to the FOCUS Cannabis Cultivation Standard is an easy route that cultivation operations can take to ensure all products meet specifications. Recalls can be the quick end of a company, and meeting the guidelines of this certification is one way to ensure that business will continue to prosper. FOCUS Standards are set by leading experts in the fields of quality management and can help ensure the safety and health of all those receiving cannabis related products.

References:

1. Gunasekara, Amrith S. “Environmental Fate of Pyrethrins.” Environmental Monitoring Branch, Department of Pesticide Regulation, Sacramento, CA, 2004.
2. https://www.oregon.gov/ODA/programs/Pesticides/Pages/CannabisPesticides.aspx
3. https://www.oregon.gov/ODA/shared/Documents/Publications/PesticidesPARC/GuidelistPesticideCannabis.pdf

About the Author

Andrew Samann is the founder of Orion GMP Solutions, LLC. He presently serves as the Chief Executive Officer and Principal Consultant.

He is a veteran of the United States Marine Corps, where he earned the rank of Sergeant. He served 2 tours in Iraq as the NCOIC leading a team of Marines responsible for quality maintenance management and documentation of over 400,000 life limited critical parts on UH- 1N and AH-1W Helicopters.

Following the Marines, Andrew earned a Bachelor of Science in Biochemistry and worked at the University of Michigan as a bio-analytical chemist, publishing three articles in peer-reviewed scientific journals.

Andrew’s professional experience includes academic research in the fields of bio-analytical chemistry and purification; pharmaceutical manufacturing of Active Pharmaceutical Ingredients utilizing Good Manufacturing Practices (GMP) and Quality Control (Analytical) chemistry utilizing FDA 21 CFR 210/211 and ICH Q7 GMP guidelines; and most recently, establishment of cannabis focused Pharmaceutical Quality Management Systems incorporating 21 CFR 210/211 and ICH Q7/Q10 GMP guidelines and Lean Six Sigma principles into cannabis product manufacturing processes.

Andrew now leads a team of Process Engineers and Chemists that design and engineer cannabis manufacturing processes based on GMP and 6 Sigma principles; the implementation of GMP Quality Management Systems; and deploy process management strategies that support scaling business/process both internally and externally while driving efficiency into manufacturing. He can be reached at [email protected].