Labs Rule Changes
Over the last 18 months, The Cannabis Alliance has worked with the WSLCB, the DOH, the WSDA, the Poison Control Center, and other industry advocacy groups toward revisions to the lab testing requirements for 502. This work was a collaborative effort by a diverse group of stakeholders volunteering their time on what was called the Quality Assurance Work Group (QAWG).
What has emerged is a nearly complete overhaul of entire sections of the Washington Administrative Code relating to 502 lab testing. Among other things, the new rules require stricter oversight of the laboratories, define punitive actions for non-compliance by laboratories, mandate proficiency testing by outside vendors to be paid for by the laboratories, and require the laboratories to maintain a higher level of documentation and training as directed by an audit checklist that is now substantially more detailed in its compliance requirements.
The Cannabis Alliance worked hard on the QAWG to get sensible and meaningful changes to the lab rules. We didn’t get everything we wanted, but we did achieve some real improvements, and there is still room for further refinement as we move forward. The code revision proposal (CR102) was filed in December of 2016. Public hearings were held in January and March of this year.
Starting on August 31st of 2017, these new rules will go into effect. Some of the testing changes will affect producers and processors directly. Most notably, the addition of a mycotoxin screen and water activity measurement will likely impact test costs and turnaround times. Not all labs are yet accredited for the new rules, so check the WSLCB’s frequently requested lists to be sure that your lab is ready. Labs with a “Yes” in the “Mycotoxin” column of the table in the link are currently certified to the new standards.
Below, we give a description of what is changing and what The Cannabis Alliance Advocated for.
What is Changing?
Microbial. New rules will eliminate the requirements for total aerobic bacteria, yeast and mold, and coliforms. The limits for enterobacteria (a.k.a. BTGN or bile tolerant) are lifted by 10x. E. coli and Salmonella spp. limits remain the same.
Water Activity. Water activity is a new test requirement for flower. Water activity (Aw) is a measure of how much unbound water is available for microbial growth. Aw correlates with moisture content and may end up being a more useful indicator of freshness. It is information intended to supplement the moisture analysis and the microbiological analysis. Adding water activity was a compromise for relaxing the microbial limits.
Mycotoxins. Mycotoxins are a new test requirement for flower. All flower now needs a mycotoxin test. Additionally, any extract or concentrate made from untested flower will need mycotoxin testing, as well. Mycotoxins are toxic chemicals produced by some species of mold. They can cause acute respiratory failure, and are known carcinogens. The mycotoxin test replaces the yeast and mold test.
What we advocated for:
The Cannabis Alliance advocated strongly for relaxing the microbiological test requirements. Our rational was that in nearly all other agricultural industries, microbiological tests for board classification microorganism groups (such as “yeast and mold”) are never used as pass-fail criteria. Instead, these tests are typically optional screening tools for farmers and processors to gauge the health of their crops and facilities. While certain species within these groups may pose a public health threat, most species within these groups do not. Given this understanding, and the fact that many of our members face failures for benign and even beneficial microorganisms (such as yeast), The Cannabis Alliance advocated for removal of the broad categories in the microbiological test. The WSLCB opted to replace these requirements with tests that more specifically target known-harmful microbiological contaminants and indicators of spoilage, and that became the compromise. We believe that these rules will save the producers money in the long-run as fewer production lots will end up failing.
What is changing?
Residual solvent screening list. The QAWG identified the residual solvent screening requirements as an area where clarification was needed. Formerly, the rules simply stated which solvents were allowed for use and instructed the labs to screen for “residual solvents” without defining what specific solvents to screen for. After 3 years under this framework, the labs have demonstrated evidence that even when processors are using only approved solvents, sometimes unapproved solvents still make their way into the final product; often, it is not the approved solvent that is concerning, but impurities within the approved solvent (or cleaning solutions) that we should worry about. Additionally, research and proposals out of Colorado corroborated the claim that solvent impurities are of concern, and indicated that the approved solvents are not human health hazards even at concentrations 10x higher than previously allowed. The QAWG referenced the US Pharmacopoeia’s residual solvent limits for Class 1, Class 2, and Class 3 solvents when drafting the new testing rules. In the end, the new rules specify a list of 15 specific solvents and solvent impurities that the labs must begin screening for. The list of approved solvents for USE in an extraction setting has NOT CHANGED.
Required tests for CO2 and EHO. Under the new testing rules, CO2 and Ethanol extracts will no longer require the microbiological test. Instead, they will require the residual solvent test. The rational for this is that both CO2 and EHO extraction processes typically involve dissolving the product in ethanol, which will effectively kill most human pathogens, thus rendering the microbiological test superfluous. Instead, the board elected to add residual solvent screening to the list of requirements for CO2 and EHO, as ethanol can have impurities of ethyl-acetate, iso-propanol, n-propanol, and methanol, most of which do not purge as easily as ethanol. There is no limit for ethanol, but we strongly recommend you try to keep it under 2%.
What we advocated for:
The Cannabis Alliance advocated strongly for keeping ethanol off the residual solvent screening list. Our members, including our lab members, made it clear to us that the proposed limit for ethanol at 2,500ppm would put most CO2 and EHO products off the market. We successfully brought forth the case that ethanol is a safe and effective viscosity agent for vape pens, that other viscosity agents are more potentially harmful, and that purging the ethanol to such a low level will also strip the more volatile terpenes rendering the final product less valuable. The Cannabis Alliance, with the help of many of its members, was able to convince the WSLCB that ethanol should be monitored but not limited. We were successful in keeping ethanol off the limits table in exchange for screening products for ethanol impurities.
We recommend taking the time to speak with your lab about how these changes will impact your business.