Those who manage cannabis or hemp testing labs in the US have had to face numerous challenges since the industry got its start, including frequently changing or non-existent regulations and standards—which have contributed to accuracy issues—becoming certified, and in setting up and operating their labs. However, recent developments show those issues are slowly being resolved as more regulatory bodies get involved in the industry and communication between testing labs and regulatory groups gets stronger.
In our latest Big Picture series, those in the cannabis and hemp testing industry share recent trends, as well as their advice for new labs, particularly relating to proficiency testing and becoming certified.
Regulation and standards-related challenges
When it comes to cannabis and hemp testing, regulations that do exist vary from state to state and change often, while the fact that cannabis remains illegal at the federal level brings another set of challenges. However, there are signs that the industry is gaining more stability in terms of standards and regulations, not only making managing a cannabis or hemp lab a little less stressful, but, more importantly, ensuring the safety and quality of these products for consumers.
More consistency seems to be on the horizon as more regulatory bodies engage with various scientific groups, such as AOAC International, and those groups continue to work on developing standards for cannabis and hemp testing. For example, AOAC has established its Cannabis Analytical Science Program (CASP), which provides a forum for the discussion of hemp and cannabis science and the development of standards and methods for the industry. Most recently, the organization granted approval to an analytical method developed by Agilent Technologies and CEM Corporation to determine heavy metals in cannabis.
“This method provides the cannabis analytical science community a gold standard, which is especially critical for our young market,” said Julie Kowalski, independent consultant and CASP working group chair in a press release. “With this addition to the suite of CASP contaminants methods, testing labs, regulators, and consumers can feel confident that AOAC is making strides to ensure quality testing and, ultimately, product safety.”
According to Susan Audino, PhD, an analytical chemist/chemometrician and independent consultant with expertise in the cannabis testing industry, there are a few key trends regarding regulations that will have a positive impact:
- Non-scientist regulators continue to be “more willing to embrace and learn science”
- The establishment of the Cannabis Regulators Association (CANNRA) cooperative, which involves more than 30 state regulatory bodies
- The regulatory infrastructure is becoming more centralized, meaning more consistency
- Strong collaboration between all stakeholders (scientists, testing labs, regulatory agencies, etc.)
Audino says these trends mean that all stakeholders in the cannabis testing industry will be better served.
However, though many in the industry are optimistic about these recent trends, it will likely still take time for convergence on regulations to fully develop, according to Milan Patel, CEO and co-founder of PathogenDx, a manufacturer of pathogen tests for the cannabis industry.
“We are not completely there, especially with the ‘unknown’ of what the regulations could look like under a federalized model,” said Patel, whose company recently received certification from the AOAC Research Institute for its quantitative microarray test for cannabis. “We’ve seen the USDA weigh in on hemp, and that is the first signal of what the future could look like. Given the unique position cannabis sits in with respect to a plant that has medicinal values, can be sold as edibles (food), and as supplementals, the regulatory framework cuts across major agencies and will take some time to unfold.”
Accuracy issues in cannabis and hemp testing labs
Without standardized methods for cannabis and hemp testing labs, testing accuracy has been an issue as results can vary greatly from lab to lab. That has also led to so-called lab shopping, where, if those producing cannabis or hemp products get an unfavorable test result at one lab, will simply go to another lab or have the test re-run with a less sensitive method until they get the results they want. Labs have thus been penalized for having more sensitive and accurate methods through the loss of customers.
However, this issue is slowly getting resolved as regulatory bodies continue to work with testing labs and other groups to develop standardized testing methods. Proficiency testing (PT) is also helping to ensure consistency and quality among the results produced by various labs. Though it’s not required for all cannabis and hemp labs, more in the industry are adopting proficiency tests, according to Kirsten Blake, vice president of Emerald Scientific, a company that provides proficiency tests to the cannabis and hemp testing industry and also runs a PT program. She adds this PT trend will likely become part of a larger move of the industry toward implementing processes such as good manufacturing practices, which will only improve the consistency and quality of testing.
How to set up and run a cannabis testing lab
As more states legalize cannabis and regulations continue to evolve, the need for cannabis and hemp testing labs is expected to continue increasing. According to an article by Damon Anderson, PhD, technology editor at LabX.com, those looking to set up a hemp or cannabis testing lab will want to do the following before getting started:
- Define the goals of the operation
- Figure out what the lab will test and where it will be located and licensed
- Determine the types of testing the lab will perform
- Research the legal requirements for testing in the market where the lab is located
Once these steps are completed, the organization should have a good idea of the instrumentation needed for the lab and the performance they’ll require from the lab itself, which will in turn determine budgets and staff required.
Anderson’s article also covers what new labs should look for when sourcing lab equipment and testing supplies, and some keys to running a successful cannabis testing lab once everything is in place. As with any lab, staffing is especially important in cannabis testing as, while there are still routine tasks that many workers can do, the industry requires those with the technical expertise to understand the technologies and instrumentation used and who can make key decisions for the lab, Anderson notes.
As Audino points out in this Q&A article, the benefits of analytical tech and instrumentation in the cannabis testing space can only be realized by staff who know what they are doing. “Although just about anyone can be taught the buttons to push, understanding what’s going on inside that black box is critically important and should never be underestimated,” she says.
Ensuring a successful lab certification process
Once labs are up and running, becoming ISO/IEC 17025 accredited is another key step to help ensure high-quality testing. Blake notes that the increasing number of cannabis and hemp testing labs seeking ISO/IEC 17025 accreditation, even those whose states don’t require it, is another positive move toward consistency in testing among labs.
For those labs being certified for the first time, there are a few key points to follow to ensure success, according to both labs that have been through the process, and organizations such as A2LA that help labs become ISO/IEC 17025 certified:
- Be prepared for the process to take longer than you expect
- Make sure you understand how your state implements ISO/IEC 17025 certification, as it varies
- When writing your SOPs, be sure to consider what your future testing volume is likely to be
- If you have no experience with ISO/IEC 17025 accreditation, bring on a trusted partner who does
- For proficiency testing, develop a strong relationship with regulatory contacts early and do practice tests to ensure the lab fully understands the rules and is properly prepared
While certification goes a long way to helping testing labs ensure they produce accurate results, the industry does still face challenges in ensuring all labs are regularly following the policies required to be accredited, according to Lucas Mason, president of Aurum Labs, a full-service cannabis and hemp testing lab in Colorado. Though this and other challenges continue to persist, those in cannabis and hemp testing agree the industry has come a long way from its beginnings when there was essentially no oversight at all.
While the testing industry as a whole still faces a number of issues as it continues to mature, recent trends indicate that it is progressing to a point where clear regulations and definitive standards will be the norm.