Pennsylvania regulators approved the state’s final medical cannabis regulations Oct. 20, ushering in permanent rules for an industry that has been operating under temporary guidelines since sales launched in early 2018.
The final regulations, adopted by the Independent Regulatory Review Commission in a 4-0 vote, have raised some concern for industry stakeholders, particularly when it comes to testing.
Under Pennsylvania’s temporary medical cannabis regulations, the state’s licensed grower/processors could use one lab to test their products. Now, under the new rules, licensees must have their material tested twice by two different labs—once when the plants are harvested and a second time after the cannabis has been processed into finished products.
“That is certainly a drastic change and one which is not welcome by industry stakeholders,” says Meredith Buettner, executive director for the Pennsylvania Cannabis Coalition (PCC). “It’s certainly going to be challenging to implement from a grower/processor standpoint. The laboratories have serious concerns. We have, I think, program-wide concerns about if our state-mandated seed-to-sale system, MJ Freeway, is going to be able to handle the [Department of Health’s] thoughts about this.”
The root concern, Buettner says, is that many industry stakeholders doubt that the department has the statutory authority to force operators to use two separate labs for harvest testing and final product testing.
And, she adds, many stakeholders argue that there is no reason to use two labs in the first place.
“Our program is already unique in that it requires harvest testing and final form testing,” Buettner says. “We’re doing two tests on flower that’s intended to be sold as flower. Also, vice versa, [we’re] doing testing on flower that intends to be processed, manufactured, concentrated and sold as a concentrate, and we’re testing it at two different points.”
So, why require one lab to do one test and another lab to do the other test, especially if it will create what Buettner calls “enormous challenges” for the industry?
The Pennsylvania Department of Health has cited patient safety as the reason for requiring two separate labs to test medical cannabis products in the state, but Buettner disagrees with their argument.
“There seems to be this concern with contaminants—heavy metals, pesticides, etc.—getting through initial testing and ending up in final products, which really couldn’t happen,” she says. “If those things are found during the initial harvest test, … because we only have the ability to remediate [that material] into topical products here in Pennsylvania, if we’re testing flower that’s intended to be flower at harvest and it’s hot for heavy metals, that product has to be destroyed. We can’t move it through in the process. If we had remediation, maybe we would want to be double checking for those things but generally, some of the things that they’ve expressed concern about, they fundamentally could not happen with the way our testing works.”
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Lindsay Whitmer, VP of regulatory compliance for Pennsylvania-based Ethos Cannabis, which also operates in Ohio, Massachusetts and Maryland, adds that if regulators believe labs are providing inaccurate test results, then they should address that issue with the labs rather than forcing the state’s cannabis operators to use multiple labs in their testing protocols.
“The regulation that’s requiring grow/process facilities to use more than one testing lab is not getting at the root cause of what the problem is,” Whitmer says. “The Department of Health is concerned that they’re not getting accurate or consistent test results out of the labs, and therefore, created this regulation that is saying, ‘Hey, grow/process, you need to go to two labs,’ … but it really isn’t addressing the problem whatsoever and it’s actually causing more problems. If you don’t have robust quality control at your lab, the way to address it is to fix that, not to say that a grow/process facility go to multiple labs.”
The two-lab requirement will likely lead to increased testing costs, Buettner says, especially as operators are less likely to be able to take advantage of volume discounts when splitting their material between two separate labs.
And these increased costs will likely get handed down to Pennsylvania’s patients, Buettner adds.
“We’re always looking at ways to reduce the cost of medicine, so when the department is putting out a regulation that looks like it’s going to increase cost, we’re always going to fight against that to ensure that we can bring the cost down,” Buettner says.
She believes the challenges extend beyond an uptick in cost, however.
When one lab performs harvest testing and final product testing, for example, that lab can work with the grower/processor to reconcile any discrepancies in the results. When two labs are involved, it can be more difficult to pinpoint what went wrong.
“For example, if a specific terpene degraded significantly from harvest test to final product test, sometimes we’re able to work through the scientific processes of forming the concentrate or producing the product with that laboratory and say, ‘Well, this may have done that’ or ‘That may have done that,’” Buettner says. “We’re able to use the information when it’s carried across the same laboratory in a way that benefits patients at the end of the day. We will not be able to have that same kind of feedback about test results when one lab is testing the initial harvest test and another lab is doing the other [test]. You’re just going to have to say, ‘OK, well, the results are different.’ You’re not going to be able to have a congruent conversation about the results related to that product.”
Whitmer echoes these concerns.
“If you’re testing a batch of product, you send it to one lab, you get one result,” she says. “You send it to another lab, you get another result. There’s going to be a lot of difficulty in reconciling that information now dealing with two quality control labs, dealing with the operator, and the slow release of that batch.”
Whitmer says Ethos is “awesome with compliance,” and that the company’s core values include end products that are of the utmost quality.
“Ethos goes above and beyond even the bare-bones state requirements,” she says. “We’re testing at multiple points within our production process to make sure that we’re providing the highest quality products.”
That’s not to say that the new testing regulations won’t impact Ethos’ operations in Pennsylvania; Whitmer says the two-lab rule will likely cause inefficiencies within the company as it deals with multiple labs.
“We want to partner with the best quality control lab,” she says. “And the mandate with now having to deal with multiple labs, it just creates an inefficiency for us that isn’t ideal. But that being said, we are a company that stands on compliance and has a very good rapport with the Department of Health. So, what the regulations are is what we will do.”
Now that final regulations are in place, Buettner says regulators can amend individual rules—and she hopes the Department of Health will continue to consider testing requirements as the industry matures.
“I will tell you that despite the Independent Regulatory Review Commission approving these regulations, several of the commissioners were very clear that they find this particular regulation that we’re talking about—the testing piece—to be troublesome, and they encouraged the department to continue to work with the regulated industry to address that,” she says.
Whitmer is also optimistic that any issues with the final regulations will ultimately be resolved.
“One thing that I find very positive is that the [Department of Health] and ultimately the government of Pennsylvania has really allowed a lot of opportunity for people to provide feedback and comments,” she says. There have been significant comments made on both sides—the arguments from the processors and the owners and the dispensary managers, [and opportunities for] the pharmacists to chime in, doctors to chime in, [as well as] a lot of critical people within the cannabis space, so I think that’s awesome.”
Overall, both Whitmer and Buettner are glad to see Pennsylvania’s medical cannabis program operating under a final set of rules after spending more than four years adhering to temporary regulations.
“I think there is something important to be said for moving on to final regulations and allowing for a more normal regulatory experience,” Buettner says. “We look forward to working with our regulators for full implementation.”
“I’m very hopeful that it seems like the [Department of Health] is open to hear what people have to say, which I think is awesome,” Whitmer adds. “The regulations are coming out, they’re getting revised, they will improve over time, but it’s going to be a process.”