In particular, Engelking notes that the absence of federal GMP guidelines means that because the cannabis industry was built state by state, this important guidance was not developed. “The industry has developed without an understanding of basic food safety principles, or the importance of organizational culture in effectively implementing a food safety management system,” she adds.
GMPs for Cannabis
Developing GMPs for cannabis requires a clear understanding of how cannabis is produced and refined into edible products, which sometimes occurs all in the same location. Dr. Knutson gives the example of a facility with which she works that has vertically integrated its site. In the same production plant, the company cultivates cannabis, extracts cannabinoids from the plants they’ve cultivated, and bakes them into edibles in an area they call the “cannabis kitchen.” Each zone must be protected in different ways, sometimes from different pathogens.
“The flower is going into extraction, and the concentrate is then going into the edibles, all within these four walls,” Dr. Knutson says. “In terms of GMPs, starting at cultivation, there is the importance of having separate air handling. The cannabis kitchen has its own roof-mounted HVAC unit, and it has its own dehumidifier so the two sides of air have been physically separated from each other.” She goes on to detail the various concerns for developing GMPs in a vertically integrated site, which include everything from dedicated footwear and uniforms to considering where freight carriers like forklifts and handtrucks have been prior to entering the facility to deliver ingredients.
Yet from a macro perspective, says Vaillencourt, the process of applying GMPs to cannabis-infused foods shouldn’t be significantly more complicated than it is with traditional foods. He counsels producers to consider the demands of the ISO 9001 quality management and risk assessment system. “Start with a basic quality management system,” he says. “Are you making infused products? Does that mean it’s orally ingested? What are the risks and what controls do I put in place to address the risks? Logically, that should lead you to food GMPs, preventive controls, sanitation, environmental monitoring, and allergens. Just apply logic; let’s not reinvent the wheel.”
Change Is Happening Already
Because legalization has occurred one state at a time, the process of developing food safety for cannabis products has likewise happened state by state. Vaillencourt notes that New York is beginning to require GMPs for CBD-infused products, while Florida was the first state to demand GMP certification in its cannabis laws.
“Then of course people called them to ask, ‘What does that mean? It’s a federal thing. Nobody can give me a federal GMP certification.’ And the state was like, ‘I don’t know,’ and they literally wouldn’t answer anybody. You can’t just flip a light switch and tell a billion-dollar market, ‘You have to be GMP tomorrow.’”
But states have to do something, and they’re trying. Vaillencourt says that Michigan is toying with provisions for GMP, while in his home state, the Colorado Marijuana Enforcement Division has taken notice. “Within the last 18 months,” he says, “we went from ‘What the heck are GMPs?’ to ‘Everybody’s on board with this, we want to get to a GMP system. How do we do that?’”
The answer isn’t easy. Engelking says she’s been happy to see state programs evolving to include more food safety requirements, but she laments that, too often, they’re just box-checking compliance demands. “As a result, little or no emphasis is placed on doing the hard work of changing the organizational culture and behaviors, which are the backbone of any effective management system,” she says. “Industry executives must make a commitment to implement and maintain GMP standards, even if not yet required by regulation. For this to happen, the C-suite must understand how standards and good manufacturing practices can benefit their bottom line.”
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