Susan Audino, PhD, analytical chemist/chemometrician and independent consultant, shares her experience within the cannabis science industry, and highlights opportunities for growth and improvement among cannabis testing laboratories.
Q: What is the main hurdle for cannabis testing labs to become profitable?
A: Most likely it will be customer retention. Laboratories are largely operating during a time of ambiguity with insufficient direction that results in customers directing laboratory science. For example, a laboratory that has developed an exceptionally precise and accurate test method with well-defined measurement uncertainties may provide test results that are not favorable to a customer. When faced with the loss of that customer, a laboratory may make a business decision to amend the test method to reduce performance, and thereby provide larger uncertainty (presumably to capture the regulatory specifications) in order to meet customer requirements.
Q: What are some of the most expensive aspects of running a cannabis testing lab?
A: This will be capital expenses for a start-up laboratory. Instruments are expensive. In my opinion, staffing would be next in line. Laboratories should strive for highly experienced laboratory personnel who have “been around the block” a few times and who have developed an arsenal of problem-solving skills to address the inevitable wrinkles that present at a laboratory. Related to this is staff retention—staff need to feel respected for their work as scientists, need to be appreciated for the scientific integrity they bring to the laboratory, and be provided external opportunities for professional development. All of these elements position the laboratory for technical success. Finally, another major expense is consumable materials, such as reference materials that should be integral to every assay.
Q: What are the biggest challenges associated with running a cannabis lab today?
A: Regulatory specifications that may not always be based on sound scientific processes or abilities. This positions the laboratory to develop methods presumably to ensure consumer health and safety, but can drive laboratory customers (product manufacturers) out of business. Essentially, the laboratory is forced to juggle regulatory requirements (to be in business) with customer needs (to stay in business) and scientific integrity (to ensure confidence in results), which inevitably leads to compromise.
Q: How have you seen instrumentation improve to better suit the needs of cannabis testing labs?
A: Instrumentation and applications for instruments have continually improved just as they have in other industries. Ultimately, the benefits and utilities of instruments can only be realized by well-experienced scientists, many of whom have only cursory experience/knowledge and do not fully embrace the capacity of their equipment. As instruments and their drivers advance, they often appear to be “plug and play” and give the appearance of “anyone can run this,” which of course, is not true. 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.
Q: How has the regulatory landscape evolved recently, and how do you envision it will change in the next few years?
A: I continue to admire and respect the incredible work of all regulatory bodies. They were put in a position where essentially overnight they were required to change from prosecution to regulation for consumer safety. What an incredible paradigm shift for them! Nevertheless, this resulted in regulations driving science, and because science is always time-consuming and is late to the game, the landscape is evolving. It has been exciting to see non-scientist regulators more willing to embrace and learn science. As an entity, they continue to engage with scientific communities such as AOAC International. Most recently the CANNRA cooperative has been developed, which currently engages more than 30 state regulatory bodies. As the regulatory infrastructure becomes more centralized and their collaboration with science continues, the landscape will also evolve. Only through collaborative efforts will the natural order shift and laboratories will not have to compromise science to maintain their customer base to remain in business.
Q: Where is the cannabis industry currently in terms of standardizing testing/methodology?
A: Several organizations have been attempting to standardize testing methodology and overall laboratory testing. First and foremost, ISO/IEC 17025 is essentially a staple for every testing laboratory. As the international gold standard for technical competence, this should be a requirement. The standard does not prescribe practices for the cannabis industry; in its entirety, it requires the laboratory to develop a system based on individual risk. This flexibility frequently leads laboratories to do the bare minimum to ensure compliance. Thus, there are several organizations currently developing requirements to supplement ISO/IEC 17025 that will provide cannabis laboratories more specific direction and higher expectations. Supplement requirements are not new and exist in other industries, such as food.
On the front for actual test methods, several organizations are developing standardized methods. Several test methods have gone through single and multiple laboratory validations and have been published. We have to remember that sound scientific processes do not occur in a vacuum and are not quickly developed; they take time. Also, it is important to remember that vetting a test method as a standard test method should not be based on a popularity contest. It must be vetted by experts with known and demonstrated expertise in the subject matter to ensure the (candidate) methods are sound and fit for purpose.
Q: What future trends do you see for the cannabis research/testing industry?
A: It is exciting to see cannabis research develop. It has been a long time coming, and the possibilities are endless. The testing industry is a little different from research. Here, we are concerned with developing statistically confident test methods that are fit for purpose. Whereas research is concerned about discovery of empirical evidence to support a hypothesis, testing laboratories are (typically) concerned about quality control of a given sample. These third-party testing laboratories require robust methods and technical competence that attest to the veracity of results to (ultimately) ensure consumer safety.
As I mentioned earlier, the continued collaboration among regulators, testing laboratories, and scientific organizations will ultimately trend the industry to a better foundation to serve all stakeholders.
Susan Audino, PhD, is an analytical chemist/chemometrician and independent consultant (S. Audino & Associates, LLC) to chemical and biological laboratories. As a contractor for accreditation bodies, she assesses laboratories to and is an instructor for multiple ISO/IEC standards, including ISO/IEC 17025. Dr. Audino is on the board of directors of the Center for Research on Environmental Medicine and Board of Associates of Hood College. She is highly visible in the cannabis industry and is a recognized leader for the development of official/consensus test methods and quality in cannabis laboratory science. She has been a member of technical expert review and advisory panels, currently serves as the science advisor to the AOAC International Cannabis Analytical Science Program (CASP), advises several cannabis testing laboratories, private and nonprofit cannabis organizations, and recently joined the Analytical Cannabis editorial advisory board. Dr. Audino has chaired analytical cannabis working groups, was a member of the NCIA Guide for Laboratory Testing, is on the Emerald Scientific Advisory Panel, and has consulted for many organizations and regulatory bodies. She has been invited to speak at numerous domestic and international scientific conferences. Dr. Audino is principal of multiple independent companies, has several patents pending, and is a contributing author to Cannabis Laboratory Fundamentals, published by Springer Nature in 2021.