As cannabis companies race to develop edibles and extracts, testing labs are in a sprint of their own to figure out how to manage a hugely expanded range of products.
Last week, Health Canada released draft rules for the new regulatory framework that will govern infused foods, extracts and topicals when they are legalized in 2019. Over the next 10 months, labs will have to refine ways of testing these products, separating cannabinoids from sticky food materials and testing for pesticides and solvents in a complex stew of molecules. Otherwise, the industry could be looking at a serious testing bottleneck.
"We've done everything from gummies to freezies and ice cream and cookies and brownies. Pretty much if you can think of a food product, a company has sent it to us to see if we can test it," said Jodi McDonald, president of Keystone Labs in Edmonton.
“The solvents we’re using for doing the extraction have an impact on how we are able to analyze, and some of the challenges we have seen are products that have high fat content," she said.
While experiments have been underway over the past year, labs are still trying to figure out and validate technical processes. These can be as simple as determining the most efficient way to blend solid food into a homogeneous liquid. They can also involve complicated sample cleanup, a manual process that can add hours, even days, to the testing process.
"We're talking about gummy bears, cookies you name it, and they come with very different levels of lipids, fatty acids, organic acids, sugars, sometimes food dyes, pigments, things like that. And these are the kind of things that could suppress the signal of the molecule that you're looking for. So if you're analyzing for pesticides or solvents, you really need to find a way to clean up your sample,” said Kaveh Kahen, president and CEO of Sigma Analytical Services in Toronto.
Because edibles, extracts and topicals all rely on cannabis concentrates, labs are going to have to pay special attention to pesticides, said Mr. Kahen: "When you're concentrating your THC or CBD oil through whatever process that you're doing, it's very possible that you're also concentrating the pesticides to some extent."
The proposed regulations published last week do not specify when in the production process labs need to test for pesticides. Likewise the draft rules don’t list residual solvents that labs need to test for, and don’t outline whether THC and CBD limits refer to all THC and CBD content, or only molecules that have activated through a process called decarboxylation. Mr. Kahen expects Health Canada to clarify these points in the coming months.
Both Mr. Kahen and Ms. McDonald are predicting a testing bottleneck will emerge later in the year, as an increasing number of companies try to test complicated products in a limited number of labs. “It’s not simple to start a lab,” Ms. McDonald said. “At this point, anyone who thinks they are going to solve the problem by coming online, is probably a year, year-and-a-half away from having a functional lab."
With challenges, however, comes creativity. Molecular Sciences Corp., for example, is trying to reduce testing burdens down the road by helping companies with early-stage product development. Molecular Sciences has a mobile testing lab that fits inside a semi-trailer. The lab can park at a licensed producer’s facility for several weeks or months, allowing the company to test products as they are developed, instead of the time-consuming process of sending every prototype off to a lab.
"After a set amount of time, the knowledge is transferred back to the food quality management team. Now they have the knowledge to call up a lab, and say, ‘hey we've had this R&D, we know where our lessons learned are, and now I'm ready to hire a lab to do more production,’" said Brigitte Simons, vice president of laboratory business and operations at Molecular Sciences.
Ms. Simons spoke to Cannabis Professional over the phone from Nelson, B.C., where the lab was parked for several weeks testing products made by local food and cannabis entrepreneurs.
Whatever innovative ways the testing industry finds to manage the coming bottleneck, it’s essential that high standards are maintained, Mr. Kahen said.
"It will be extremely important to avoid really bad headlines ... that someone used something that was mislabelled, or was not supposed to have any THC and ended up with tons of THC, or had concentrated heavy metals or pesticides or some solvents that cause cancer. These are the kinds of things that could wipe out billions of dollars from this market and put us back many years,” he said.
Labs in the U.S. have already come under scrutiny for how much test results range from one lab to another. This will be less of a problem in Canada, said Mr. Kahen and Ms. McDonald, given the extent of federal regulation applied to all labs. However, a professional association of Canadian testing labs, which could offer standardized training and accreditation, is still needed, Ms. McDonald said.
More robust rules are also needed around the size and heterogeneity of batches licensed producers are allowed to send in for testing, she said.
“We know there is variation in a crop, across a room, across a field. Even the height of plant, how close is it to the light creates variation. And so if the sampling from the producer isn't statistically representative of what they've grown, there will be variability in the test results," Ms. McDonald said.
"If they’re not doing a representative sample, and sending top buds to one lab and bottom buds to a different lab, it will look like one lab knows what they’re doing and one lab does not know what they’re doing,” she added.