How is “good” science achieved when governments take no active role in establishing limits, validating methods, or issuing guidelines? How can standards organizations fill the void by not only trying to establish guidelines, but also to create policy in the face of the need for scientific accountability and the reality of a highly economically driven and price-conscious analytical environment? How does one demand “good” science and high accuracy when there is no legal reason for accountability, little consensus of official guidance or methods, and a driving force of economic competition between laboratories that rewards fast, cheap results that favor the manufacturers and distributors? The balancing act between “good” science and scientific accountability is widespread in the cannabis community, from the growers to the testing laboratories and beyond.
One winter afternoon, a group of professionals and scientists came together to discuss the development of test methods for cannabis. These individuals represented a variety of organizations and viewpoints, from testing laboratories and standards providers to instrument manufacturers. Several government entities, while not officially sanctioned to work with cannabis, participated as interested voices in the process. Since then, this group, which is part of an internationally recognized standards organization, convenes on a regular basis to discuss and debate the testing of cannabis in ways that will eventually lead to standardized test methods for analytes of interest. Time and again the discussions progress down a similar path of proposal, debate, and compromise, which is an integral part of the consensus and peer-reviewed method development process.
Standardized analytical methods are constructed from templates or guides, specifying key areas that are integral to the method such as scope, applicability or use, preparation and analytical procedures, analytical needs (laboratory equipment, instrumentation, standards, and so forth), performance requirements, and statistical analysis (precision, bias, and validation). In addition, current or proposed applicable regulations and requirements are examined and incorporated into the methodology. There is an understanding that the methods will be built on the rules of “good” science; they will follow the scientific method, be proven reproducible, and represent the sample or the testing appropriately. The method should function in real-world use without any agenda other than producing accurate results, which achieve satisfactory precision and bias requirements (1,2).
These methods are commonly based on either governmental or industry-driven specifications and regulations. When a new analytical sample type or product enters the testing world, it is routed to a well-established market or industry (such as environmental, consumer safety, pharmaceutical, or food safety), which then takes over its governance. Once routed, the method creation procedure is followed and appropriate governmental and accreditation agencies put their marks on the process before it is incorporated into a laboratory workflow. As testing progresses over time, methods are updated and requirements are refined but, still, the consistency of the science and the data is expected to maintain its demonstrated level of quality. The methods are supposed to represent the best available test procedures for the intended use and reflect technological advances and requirements (2).
The steps of the standard process are well-proven. For many new industries the road to regulation and testing, despite some bumps or minor detours, is a fairly straightforward path. But, for an industry such as cannabis, these traditional guidelines pose difficulties and roadblocks because cannabis, by its very nature and position in culture, is not easily adopted by regulatory and governmental parent organizations that drive testing regulations.
- Standard Format and Guidance for AOAC Standard Method Performance Requirement (SMPR) Documents (Version 12.1; 31-Jan-11).
- ASTM International, Form and Style for ASTM Standards, October 2017.
Patricia Atkins is a Senior Applications Scientist with SPEX CertiPrep in Metuchen, New Jersey and a member of both the AOAC and ASTM committees for cannabis. Direct correspondence to: [email protected]
How to Cite This Article
P. Atkins, Cannabis Science and Technology 1(2), 10-16 (2018).