Testing plays an important role in the growth of the cannabis and hemp sector. If growers and manufacturers want to shake off a century-long stigma, they cannot afford to put bad quality or unsafe products on the market.
While most hemp and cannabis programs require testing labs to be certified, certifications vary greatly depending on the state. In Missouri and Minnesota for example, labs need to be accredited with ISO/IEC 17025, an international standard that defines their required technical competence. Other states set up their own certification and licensing program, where ISO/IEC 17025 may or may not be required, like in Colorado and Arizona respectively.
For those states that don’t have a lab certification program yet (for example, New Jersey), ISO/IEC 17025 is the ideal starting point, although it’s not required by the USDA: “ISO/IEC 17025 is not specific to cannabis, but if at a minimum a state requires it, then a good majority of standards will already be in place,” says Lori Dodson, senior advisor at Maryland Medical Cannabis Commission, and co-chair of the Special Committee on Lab Testing and Product Safety of The Cannabis Regulators Association (CANNRA).
For labs working on their first certification, the process might take longer than expected: “An important part is about learning the language,” says Lucas Mason, president of Colorado-based Aurum Labs. “A single sentence in the ISO requirements is a topic you could discuss for an hour. It's not as easy as filling out a checklist and sending it.”
What can make a difference is also how the state implements its program: “In Colorado, it was built over time,” says Mason. “Every year a new major test was added, so we weren't taking in so much at once. In Nevada for example, they came out with all the requirements right on the onset.”
When writing your SOPs, explains Mason, it's important to think ahead: “It’s a delicate balance between being thorough and not burying yourself with paperwork. It's very easy to write procedures when your volume is 40 samples a day, but once it doubles or triples, you'll have to adapt them.”
Having previous experience also helps make the process faster. “We got our certifications all on our own, but it would have been a very daunting task, if I hadn’t already conducted ISO/EIC 17025 audits in a previous job.”
Mason’s case, however, seems to be the exception rather than the rule. Labs that are new to the certification process will have to learn the minimum requirements first, possibly with the help of an accreditation body.
“A lot of laboratories apply for accreditation without being well prepared to have an assessment,” says Chris Gunning, general manager for Accreditation Services of the American Association for Laboratory Accreditation (A2LA), one of the few accreditation bodies in the US for hemp and cannabis labs. “Most deficiencies are in their ability to demonstrate that they have validated their test methods. That’s the main time limiting step, because validation studies are not quick.”
Having different certifications can also mean redundancy of audits: “A lot of states perform their own assessment in addition to ours, so the laboratory is being hit multiple times a year with audits,” says Gunning. “We're working with each state regulator to show them that they can have confidence in the accreditation process, so when we do our ISO/IEC 17025 assessments, we can assess their requirements as well.”
However, as Gunning explains, things have improved considerably: “Labs are better prepared than two or three years ago, and the timeline from application to accreditation is shortening. Right now, it’s roughly four and a half months for well-prepared labs, while previously it would take well over a year two.”
The current legislation of hemp and cannabis creates additional hurdles to labs seeking accreditation. On one hand, testing procedures of cannabis and hemp are the same and will generally include mold, mycotoxins, pesticides, heavy metals, and residual solvents; on the other, until its THC content is confirmed, each cannabis plant is treated as a potential Schedule I drug.
For this reason, starting December 31, 2022, all hemp testing labs will have to register with the DEA, according to a USDA spokesperson reached on Nov. 29. This requirement, however, may come with an extra step: “Cannabis testing labs that also want to test hemp cannot get DEA-registered because cannabis is federally illegal. Therefore, multiple organizations are being required to set up separate entities to test each substance,” says Gunning.
"We're hoping that accreditation is going to be the driver that really pushes labs to be more consistent across the board.”
A normal practice like proficiency testing also becomes more complicated when it comes to hemp and cannabis: “Right now, a proficiency testing program using cannabis flower is not possible due to the Schedule I status of the plant,” says Dodson. Also, even if we were able to ship the plant material across the country, there would be too much variability between samples.”
A similar issue occurs at the state level too: “Many states won’t allow a lab to test cannabis prior to receiving their accreditation. In their initial assessment, they will have to use a surrogate to show that they can perform the test,” explains Gunning.
A grey area
The lack of common certification standards creates issues particularly with intrastate commerce of hemp. If there is no agreement when it comes to analytes, pass/fail criteria, and SOPs, how can a hemp product tested in one state be sold in another?
Once again, solutions can vary.
“In Maryland, it’s mandatory to have THC/CBD levels tested by a local lab if hemp is used by a licensed processor,” explains Dodson. “Hemp products sold in final form in dispensaries need to be tested and certified by a lab registered in our state, otherwise they must include a disclaimer on the label.”
Another solution is to become an approved laboratory in other states that offer this option, like Texas.
The general expert view, however, is that testing for interstate commerce of hemp is still a grey area where labs need to be proactive: “The biggest differences between states are in the limits on individual analytes, for instance, pesticides. Testing laboratories that want to attract growers looking to sell their products in multiple states, will need to validate their methods to be compliant with each individual state,” says Gunning.
That may be easier if you’re already based in a state with stricter requirements: “Florida, for example, is one of the states with the strictest regulations. If your test your products here, you meet the standards in almost all the US,” says Roger Brown, president of Florida-based ACS Laboratory.
Unfortunately, this grey area also creates opportunities for bad practices, such as lab shopping—where growers will send the same sample to different labs until they get a potency result below 0.3 percent—or incomplete testing.
“Some manufacturers test more than what's required, because they want to put out high-quality products,” says Brown. “But just like in any industry, there are outliers that don't test for contaminants, they just want to know the levels of cannabinoids and sell them over the internet. Unfortunately, there's not a lot of teeth in the regulations against bad corporate citizens and regulators are not really able to enforce rules. If you get the piece of paper certifying a laboratory and the next day you don't follow ISO procedures and SOPs, nobody comes in on a surprise inspection.”
Mason echoes this opinion: “Lab certifications are useful, but they’re not the end all be all. It doesn’t mean that everything tested by this lab is going to be safe. It comes down to whether or not those policies and procedures are being followed daily.”
“One of my concerns,” he adds, “is whether there's something in a product that the lab is not looking for yet, and what the risk-based tolerance levels should be. That’s an aspect we're still learning.”
For Brown, what could help the hemp industry is federal supervision: “Food, vitamins, supplements, clinical laboratories, they’re all regulated on a national basis, so why not hemp and hemp testing labs? Once we get there, the industry will rise even more.”
An evolving scenario
Despite these multiple issues, things have improved considerably in the past four years: “When we started in 2014, there weren’t really any standardized test methods or even product quality criteria; we worked a lot with the regulators to develop them,” says Mason.
“When the first states implemented their hemp programs, there were no boundaries or guardrails in place for labs to do the right thing,” says Dodson. “But this was in 2017. It evolved a lot since then and it keeps evolving. It's been only four years, but cannabis is such a dynamic environment that it seems like 25.”
“There is still some shakiness in the industry,” continues Dodson, “but state communication has grown immensely and will continue to grow. Testing is going to be less ambiguous for labs, because we now have standard methods available through various organizations. We're hoping that accreditation is going to be the driver that really pushes labs to be more consistent across the board.”