A2LA Today l September 2016 l Number 132
By Susan Audino, S.A. Audino and Associates, LLC
*reprinted from the May/June 2016 issue of AOAC Inside Laboratory Management
AOAC and industry are partnering to develop Standard Method Performance Requirements (SMPRs®) in an effort to find the best testing method(s) for cannabis. Analytical testing in the cannabis sector is greatly suffering from a lack of standardization and appropriately vetted methods that have been rigorously evaluated. The result is diminished consumer safety and insufficient knowledge about a legally acquired and purchased commodity.
“One of the biggest challenges facing the cannabis industry is the lack of consensus on standards and test methods,” said AOAC Executive Director, James Bradford. “AOAC can help by gathering stakeholders and experts to work toward consensus in setting standards and finding the best method(s). AOAC will implement its working group strategy in which relevant standards development activities are supported by Organizational Affiliates (OAs) and leverage existing AOAC stakeholder panels.”
Work on cannabis will be part of the AOAC Stakeholder Panel on Strategic Food Analytical Methods (SPSFAM) activities.
Regardless of personal opinion, cannabis use is widely sanctioned and is only growing in availability and use. Just as they do with other foods and botanicals, consumers have a right to know what they are getting and that it is safe from intentional or accidental adulteration.
As of this writing, 24 states and the District of Columbia have sanctioned medical use of cannabis, and four of these states also permit adult use. Cannabis consumers range from toddlers to the geriatric population as well as household pets. Cannabis can be used to treat a host of diseases, disorders, and illnesses.
There is a wide variety of cannabis delivery systems from which to choose: smoking, vapor, tincture, salves and creams, sublingual films, transdermal patches, and, of course, infused edible products.
The cannabis plant may be grown under “organic” conditions, outdoors, indoors, or even hydroponically. This is a huge business prompting all sorts of entrepreneurs for businesses-like cultivation, dispensing, or even analytical testing. There is no federal oversight of the cannabis industry and possessing it remains a federal crime.
Some states have established requirements for analytical testing, and some have gone so far as to require testing laboratories to be
ISO/IEC 17025 accredited. Testing laboratories are expected to evaluate, for example, residual solvents, pesticide residue, THC potency, relative concentrations of specific cannabinoids, mycotoxins, and microbial contaminants.
Although the technology required for cannabis is no different than what is used for other botanical or agricultural products, sample matrix poses one of many significant issues. Sample source and sample size represent additional challenges. For example, raw plant material may come from bud, stem, leaf, or whole plant each of which will yield different results. Extraction from edibles can be quite challenging, particularly when the infused edibles are items such as gummy bears. Common instrumentation in cannabis testing laboratories includes HPLC, NIR, UPLC, GC, PCR, and ELISA. There is growing interest in both the carboxylated and neutral cannabinoids. Interestingly, there have been reports of analysts determining the concentrations of acidic (carboxylated) cannabinoids from the neutral (decarboxylated) chromatograms generated by GC.
The most significant issue facing the cannabis industry is the lack of consensus or standard test methods. Different laboratories get different results, leading to lack of confidence in analytical results. The quality of testing is all too often questionable, at best. Where some laboratories have developed protocols of the highest scientific integrity, others are less than adequate. Further hindering competent testing is the lack of accredited proficiency test (PT) programs. Due to the federal prohibition of cannabis, proficiency providers are not able to ship PT samples across state lines. At present, there is one Interlaboratory Comparison (ILC) program provider offering a “potency test” that is comprised of a 5-part cannabinoid matrix in methanol between 10-1000 μg mL-1, and falls within federal guidelines for interstate shipping. It is important to note that participating laboratories may use whatever method(s) they have available to them. Alternatively, intrastate laboratories are beginning to collaborate and develop their own round robin-type of interlaboratory comparison studies to ascertain technical ‘competence’ until such time that raw materials can be legally transported between states and more appropriate PT schemes can be developed.
For those states that require analytical testing and permit cultivators and/or dispensaries to transport samples to the laboratory, there are limited to no guidelines relative to the provision of samples. For example, there are few, if any, specifications as to what part or parts of the plant are to be sampled; how to choose a representative sample from the ‘batch’; or even how much sample should be provided to the laboratory. There are reports that customers have provided as little as 5g samples for analysis with no characterization of the sample or sampling protocol.
But not all is lost. The scientific community is collaborating. As part of AOAC’s standards development process, a working group on cannabis will examine analytical challenges, regulatory requirements, and gaps in current methodology, etc. in an effort to develop draft SMPRs against which candidate methods can be evaluated. The infrastructure of existing AOAC stakeholder panels (in this case, SPSFAM) will be used to advance draft standards developed by the new working group.
It is anticipated that AOAC will introduce and begin standards development activities for cannabis in September 2016 at the 130th AOAC Annual Meeting and Exposition in Dallas, Texas, USA.
For more information or if you would like to participate, contact Susan Audino, S.A. Audino & Associates, LLC, at email@example.com or Dawn Frazier, AOAC Executive for Scientific Business Development, at firstname.lastname@example.org.