I'm an extract or concentrate producer, what are my testing needs?
Extract and concentrate manufacturers face a unique set of testing requirements compared to traditional Cannabis cultivators. Check out the information below to learn more and become informed and prepared for meeting the new testing requirements set forth by OAR 333-007.
Basic Requirements
All extracts and concentrates require at a minimum, potency and pesticide testing.
Did you use solvents listed in OAR 333-007? If so, then you will also need residual solvent testing.
Potency Requirements
OAR 333-007 states that a sample will fail potency testing if:
a. The concentration is higher than allowable by the rule
b. The THC value varies by greater than 30% RSD between the primary sample and field duplicate.
Because of the THC homogeneity requirement, it is important to ensure that extracts and concentrates are well mixed and homogeneous prior to sampling!
a. The concentration is higher than allowable by the rule
b. The THC value varies by greater than 30% RSD between the primary sample and field duplicate.
Because of the THC homogeneity requirement, it is important to ensure that extracts and concentrates are well mixed and homogeneous prior to sampling!
Do you have a process validation/control study waiver on file?
Process validation waivers are a way of proving that a process produces a homogeneous product, meaning that it is of relatively equal consistency throughout the entire batch. This means that, theoretically, all cannabinoids, pesticides, solvents, etc are distributed evenly throughout the batch. Read the information below to learn the differences between sampling procedures if a validation waiver is or is not on file.
IF YES
If you have a process validation waiver on file for pesticides and/or residual solvents, then we will be collecting one primary composite sample composed of the number of increments required by ORELAP-SOP-002 as well as a field duplicate composite sample containing the same number of increments.
IF NO
If you DO NOT have a process validation waiver on file, we will be required to treat each required sample increment as a primary sample and conduct all required tests on EACH increment. As well, a field duplicate sample will be collected for potency testing. If there are any pesticide of residual solvent fails on any of the collected increments, the batch will fail. We recommend pursuing process validation waivers if you will have continued testing needs to keep the cost of testing more manageable in the long term.
Do you have a residual solvent testing waiver on file?
The requirement for residual solvent testing may be waived if the OHA or OLCC has approved a residual solvent testing waiver. To get a waiver, you must pass residual solvent testing for four consecutive process lots with the final process lot tested being at least 30 days apart from the first process lot. Contact us to learn more about obtaining a residual solvent testing waiver. If you need assistance, we may be able to offer consulting to get you through the process!
If you have a residual solvent testing waiver on file, you are exempt from residual solvent testing for any products covered by the waiver.
Do you have any other sampling or testing waivers on file?
It is possible to obtain a sampling waiver that grants the same leniency as a process validation waiver if you have the capability of submitting your standard operating procedures, methods of quality assurance, and proof that you have passed ALL required testing for four consecutive process lots with the final process lot at least 30 days after the first. If you need assistance, we may be able to offer consulting to get you through the process!