“The reality is regulation often lags behind innovation.” —Bill Maris, Google founder.
Schedule I designation for cannabis always has been a legitimate concern for industry pioneers, stakeholders, patients, and advocates. But with the rise of legalization, serious issues also lurk in state (and city) industrial standards and regulations being developed, debated, and decided in California right now, and in other states as their markets expand.
California Cannabis Manufacturers Association (CCMA) wants stakeholders and other interested parties to know that if regulations crafted now are not well informed with input from cannabis companies, advocates, and experts and carefully considered by officials—poorly written standards could kill the new industry on the vine.
CCMA President and VCC Brands founder Kenny Morrison said the organization is working with California officials to help define regulations affecting lab-testing standards and requirements for manufacturers.
“The experience has been overwhelmingly positive,” Morrison said. “Their desire to be educated is there, but even the officials themselves have told us the knowledge base required of them to do their jobs is a mile wide and an inch deep. I have a lot of respect for almost everyone I’ve met, based on their receptivity and desire to get this whole thing right.”
But the wheels of bureaucracy turn deliberately and slowly, even when oiled with the best intentions of everyone involved—especially in a state notorious for strict industrial and environmental regulation.
“When an official gets caught between the easy political benefits of regulating perception versus the more time-consuming and labor-intensive task of navigating nuance and doing the deep dive, sometimes they have to do a cost-benefit analysis,” Morrison said. “We all experience the phenomenon of not enough hours in the day.”
So, why reinvent the wheel? Right now, CCMA is focusing on process validation that will allow manufacturers to avoid costly batch testing and, instead, create compliance protocols in line with other major industries. Process validation standards would require manufacturers to be in compliance with initial process certification standards, followed by continued process verification overseen by state regulatory agencies.
According to Morrison, process validation cuts testing costs by three to ten times; this, in turn, substantially cuts the volume of testing, avoiding testing bottlenecks. Process validation also is the norm for food safety and pharmaceutical safety and is the standard in other cannabis states. Therefore, CCMA’s recommendations include employing process validation for homogeneity and finished goods consistency instead of requiring testing for every batch.
Despite the steep learning curve for lawmakers and immense challenges ahead, Morrison said all parties are trying to avoid creating regulations that don’t serve business, government, or consumers. Better to write regs manufacturers can comply with and still prioritize patients’ protections than correct mistakes later, while businesses languish from unnecessary over-regulation.
“So far [lawmakers have] done an incredible job. But there’s a lot more work to be done, especially for Lori Ajax and her bureau,” said Morrison, giving a special shout out to California’s Bureau of Medical Cannabis Regulation (BMCR) and its chief, Ajax.
“I just hope they don’t run out of time,” he added. “As the adage goes, writing is rewriting.”