I am honored to contribute to this inaugural edition of Cannabis Science and Technology! As the organizer of many cannabis science events (including the Cannabis Science Conference, Canna Boot Camps and Analytical Cannabis Symposia at Pittcon), I have worked to bridge gaps between the cannabis industry, analytical science, and medicine. This magazine represents a major leap forward in bridging these gaps, and the timing could not be more perfect.
It is my great pleasure to feature an interview-style article in each issue of Cannabis Science and Technology, where I will introduce you to cannabis science mavens and cover a diverse range of important topics. For this first installment, I focused on a cornerstone of cannabis science-cannabis quality control (QC) testing laboratories, and their evolution during the past decade.
Cannabis laboratory testing has evolved from a garage “pot science” to a multimillion-dollar industry in a very short time span. There are many companies that have played important roles in catalyzing cannabis science. Laboratories like Steep Hill, Trace Analytics, Nordic Labs, and EVIO Labs come to mind as leaders instilling quality in laboratory testing. Recently, I sat down with Lori Glauser, Co-Founder, COO, and Director of EVIO Labs, and Chris Martinez, President of EVIO Labs Florida, to discuss EVIO as well as what lies ahead for cannabis quality control testing.
Could you please introduce EVIO Labs to our readers? How many laboratory locations does EVIO have now?
Lori Glauser: EVIO Labs has quickly become a national provider of accredited cannabis testing, providing high quality analytical and consulting services for the cannabis industry. We currently have eight operating laboratories in five states (see Figure 1, right). We have several additional laboratories in various stages of development, and are working toward our goal of opening 18 locations by the end of 2018.
What are the challenges of working in different states? How do you handle those challenges (different strategies)?
Glauser: Each cannabis-legal state has unique and evolving regulations. As a multistate operator, we work to standardize our methods across labs and across states, and building our business to efficiently meet the needs of all the states rules can be challenging. So far, no two states’ testing requirements are identical. It is imperative for us to stay abreast of the regulatory changes in each state we work in, and also keep an eye on regulatory changes in states where we don't yet have labs to establish where we want to go next. We anticipate that testing regulations will converge in the future, and we will be prepared to meet a future national standard.
When I think about the evolution of cannabis science, EVIO Labs comes to mind. EVIO has expanded operations and invested in credentialed, knowledgeable staff, and world-class analytical instrumentation. How is EVIO evolving cannabis testing?
Chris Martinez: EVIO Labs Florida (see photos in Figure 2, right) is evolving the cannabis testing landscape by bringing together numerous laboratory partners dedicated to providing clients with consistent high-quality cannabis analytical services backed by quality assurance and consulting services supported by the expertise of an extensive network of industry professionals. Our clients gain access to a unique network of published research scientists, content experts, consulting partners, and business leaders to accomplish the needs of even the most complex projects.
How challenging is it to operate high-quality laboratories in an industry where customers don’t always understand why quality is so important or expensive?
Glauser: Customer education is key. Some of our customers who have been in the industry for a long time launched their businesses in an unregulated or lightly regulated environment. They are challenged with transforming their businesses to meet a whole new regulatory paradigm-not just for testing, but for security, inventory tracking, packaging, and more. Many of these customers are going through a learning process, and we help provide them with that education. For instance, we explain to customers that cannabis testing costs have increased largely because of the increased quality requirements. In the past, a $50 potency test run on an instrument that may not have been validated or calibrated was sufficient. Now requirements for quality testing panels that include pesticides, residual solvent, and microbiological contaminants using expensive instruments run by experienced scientists have increased to a $400 or more compliance test in regulated states. With the new quality requirements come far more accurate, thorough, and dependable results. The requirements are not unlike tests performed for food, nutraceutical, and pharmaceutical products where the cost of testing can reach $1000 or more and take weeks to complete. We estimate that full compliance testing in states like Nevada, Oregon, and California range from under 1% to 5% of the of the wholesale value of the batch, depending on batch sizes.
During the early months of the transition of Oregon's cannabis rules last fall, we did receive a lot of calls from customers who were dismayed by the new rules and frustrated with the increased prices. We counsel each customer and explain to them the process, including the additional instrument, expertise, and time requirements involved in each test. Another challenge customers face is that the turnaround time increases when the quality standards are increased. What used to take one day can take three or more days because of the level of rigor and quality checks required for each test. For growers who have already waited months for them to grow, harvest, and cure product, the extra few days waiting for test results can be stressful, especially for those who need to sell their product to generate revenue.
What types of certifications and accreditations does EVIO Labs have?
Glauser: All of our laboratories are either currently accredited or are seeking accreditation in their respective states. Our Oregon locations are accredited by the Oregon Environmental Laboratory Accreditation Program (ORELAP). Our laboratories in Colorado and Florida have been accredited to the ISO 17025 standard, and we are currently going through the accreditation process in our California and Massachusetts locations. Our Berkeley, California, location currently has a temporary license by the Bureau of Cannabis Control, and we are building out our Orange County location now, with expected licensing this spring.
How time-consuming or expensive is it to obtain ISO 17025 accreditation?
Glauser: The first time EVIO worked toward accreditation, which was based on the The NELAC Institute (TNI) standards, was in 2016, and the process took approximately six months. During that time, we refined and developed more than 120 standard operating procedures, policies, methods, and forms; trained our staff to meet the quality requirements; validated our instrumentation and methods; and performed "proficiency tests," which are tests we perform that are verified by third parties for accuracy. The TNI standard is a more rigorous set of nearly 900 requirements that includes all of the approximately 300 ISO 17025 standards. Once our first four laboratories were accredited, each laboratory thereafter took less time because we use the same core quality management system for all of our laboratories. EVIO Labs Florida used EVIO's core quality system and was accredited within three months. We anticipate each new laboratory will take approximately two months to go through the process. Any laboratory that is getting accredited for the first time to ISO standards should plan a 4–6 month timeline, depending on how well designed their quality management system is. The expense of engaging with the accreditation agency, generally under $10,000, is nominal compared to the massive effort required by our technical staff to prepare for accreditation-which could be upwards of $250,000 in labor plus the opportunity cost associated with our technical staff working on building the quality management system rather than serving customers.
How different are the accreditation processes from state to state? Is there one state that has a particularly good system?
Glauser: States are quite different, but several are converging on the ISO 17025 standard, and third-party verification of laboratory proficiency. Nevada, for instance, doesn't have a third-party accreditation requirement; however, the state's health department has taken a keen interest in regulating the laboratories directly. They have gone so far as shutting down laboratories temporarily for identifying quality lapses. Oregon's more stringent TNI requirements are enforced by the Oregon Health Authority's ORELAP department. We believe this is a particularly good system because the guidelines are very clearly laid out, and it provides far more detailed guidance than the ISO 17025 standards alone. Representatives in other states including New York have indicated that they look to Oregon's system as a model. California is implementing an ISO 17025 program, which I predict will become the minimum standard nationwide. I also believe that states that have a mandatory proficiency test, such as required in Oregon and newly required in California, is important. This means laboratory test results are periodically validated by a third-party to ensure accuracy.
Improved quality management systems (QMS) play a critical role in the cannabis testing evolution. Can you comment on other programs that are critical to professional integrity?
Glauser: All EVIO Labs operate under a common and rigorous QMS to ensure that our results are accurate and reliable. We also implement a continuous improvement program that brings together best practices, as well as customer, regulator, and assessor feedback from across our growing network of laboratories.
Our four Oregon locations are NELAP accredited by ORELAP and licensed by the Oregon Liquor Control Commission (OLCC) to test cannabis. This is an accreditation standard that meets and exceeds the ISO 17025 requirements, and is the quality standard for all of our laboratories. Our strategy for quality management is continuous improvement of our standards, as we bring together best practices from all the laboratories we acquire or build. Our qualified lab directors from across the nation meet at least weekly to share best practices, and continuously improve our core quality management system. For example, whenever one laboratory goes through the accreditation process, we gather feedback from the accreditation agencies, and apply any improvements to our laboratories nationwide.
Can you please tell us how EVIO Labs Florida maintains a competitive edge, and what do you envision for the future of EVIO Labs and the cannabis testing industry?
Martinez: As a veteran-owned enterprise we fulfill the state mandated diversity plan requirement for current license holder renewals and new cultivator applications. EVIO is the first to market in Florida with a world-class ISO-accredited lab that has support of EVIO’s laboratories across the United States. Our customer service is what we pride ourselves on, making ourselves available 24/7 to discuss results and support clients in reaching only the highest quality cannabis for Florida patients. The future for EVIO is bright. We are currently in expansion mode with our second laboratory in Gainesville, Florida, and are in the process of identifying a third location in Lakeland, Florida. The recent expansion into multiple cities is patient driven. EVIO offers clients the latest technology available for testing cannabis at the most competitive rates in the country. As EVIO raises the bar in cannabis testing nationwide we anticipate future laboratories will take note of the immense responsibility they have to support clean and safe cannabis through the latest analytical technology available and passionate staff who constantly put patients first.
As we work together to move cannabis science forward, it is important to honor the pioneering individuals that not only pave the way for others, but also bring quality and professionalism to the industry. Join me every quarter for interviews with key opinion leaders in many areas of cannabis science, and please continue to support and grow Cannabis Science and Technology!
Josh Crossney is the columnist and editor of “Cannabis Crossroads” and a contributing editor to Cannabis Science and Technology magazine. Crossney is also the president and CEO of CSC Events. Direct correspondence to: email@example.com
J. Crossney, Cannabis Science and Technology1(1), 70 (2018).