The recent voluntary recall of medical marijuana from a B.C. producer highlights the growing pains of a burgeoning industry coming to grips with a whole new regulatory process.
“Commercializing that has been the hurdle,” says Mark Gobuty, CEO of The Peace Naturals Project, one of the dozen producers licensed to sell medical marijuana in Canada. “Having an industry that wasn’t regulated, where you didn’t have the 8-5 shift and seven days a week operation, absolute reporting, cameras everywhere — it’s counterculture to cannabis."
"Like anything else there’s an evolution because you're working with a regulator who truly isn’t intimate with cannabis and they’ve been ordered to provide safe access."
Under the Marijuana for Medical Purposes Regulations, producers are subject to compliance and enforcement measures similar to those that regulate producers of other controlled substances. Licensed medical marijuana growers must meet strict security, control and reporting requirements, and are regularly inspected.
“You have to safely produce cannabis within a safe working environment within a repeatable procedure and be able to have the wherewithal and credentials and polices and protocols to have everything tested validated and safe,” Gobuty said.
In the case of Greenleaf Medicinals, which has since voluntarily stopped selling its product, Health Canada inspectors said they identified issues with processes that affected quality control, which included potential residues from the use of unregistered pesticides, unsanitary production conditions and concerns with testing standards.
Gobuty said all producers are required to have on site a quality assurance manager, who has passed security clearance. But growers also obligated to do third-party testing, meaning their cannabis is sent to a lab to be tested for any bacteria, fungus, mould, chemical residue or pesticides.
“We have our own testing equipment, we have calibration equipment to confirm our testing equipment is in order and we still send everything to the third-party lab for validation," he said.
Dr. Mehrdad Barghian, CEO of Quality Compliance Laboratories, one of the labs accredited to do quality assurance testing on medical marijuana, said the main focus of their testing is for the amount of cannabidiol (CBD) and tetrahydrocannabinol (THC) in a plant.
The amount of the THC determines the medical purpose of it. A higher THC percentage is better for certain therapeutics, while a lower THC percentage is better for others, Barghian said.
Microbiological testing is conducted to make sure no fungi, salmonella and E. coli have formed, and an analysis is performed to ensure the absence of lead, arsenic, cadmium and mercury, he said.
Buds are also examined to see if any insects or anything unusual is inside the bud.
Purity, safety, efficacy determine quality
“The three things that are important are purity, safety and efficacy. They are the three important things to determine quality of any product," Barghian said.
If the cannabis falls short, producers have their remediation techniques. Some will use gamma radiation to get rid of fungus or bacteria. The marijuana will be submitted again for testing, where a producer will receive a pass or fail. If a fail, a producer may try to remediate again, or destroy the plant.
“The guidelines say you can have zero detection of mould, bacteria or fungus," Gobuty said.
But the process is a continual learning curve. When Gobuty first began, it took them four days just to fill out all the reports required, he said.
And then there's the constant discovery of better practices. For example, Gobuty says his staff used to wear lab coats, shoe covering, hair nets and gloves for indoors and outdoors. Now they wear jumpsuits, which they take off and dispose of, just when moving from room to room.
“We are the carriers of the bugs. One little one jumps on your leg in one room and jumps off in the other and suddenly you have a problem in that room.”
Gobuty said while Health Canada sets regulations, it doesn’t tell producers how to run their operations.
“They don’t tell you how to run your drying room. There’s procedures. So when you have good manufacturing processes and you have protocols in place, and you follow those protocols, you will know how to successfully dry and dehumidify and cure cannabis.
"Health Canada is not an expert in any of that. What they are an expert in is confirming what you say you're going to do and then validating your test results."