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Ask The Expert: Exploring Cannabis Laboratory Accreditation Part 2

By Aaron G. Biros
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In the first part of this series, Michelle Bradac, senior accreditation officer at the American Association for Laboratory Accreditation (A2LA), told us about the basics of laboratory accreditation, what it means and why it is such a cornerstone of product safety. In this next piece, we sit down with Roger Brauninger, A2LA Biosafety Program manager, to learn why states are looking to lab accreditation in their regulations for the cannabis industry.

Brauninger has worked at A2LA since 1999. As the manager of their biosafety program, his focus is on developing and maintaining accreditation programs in the life sciences. Brauninger has conducted a number of management system assessments to ISO/IEC 17025 and 17020 and also evaluates other assessors in this role.

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Roger Brauninger, A2LA biosafety program manager

He is A2LA’s point person for interacting with organizations working with food and drug safety, human and animal anti-doping, biological and chemical threat agents and since 2014 for issues related to cannabis testing. He is a member of the ASTM D37 Cannabis committee, a group focused on creating standards for cannabis products. He was also a member of the stakeholder panel on strategic food analytical methods (SPSFAM) cannabis potency working group when they were awarded the Official Methods Board (OMB) award for achievement in technical and scientific excellence at the AOAC’s Annual Meeting and Exposition in Atlanta, GA. Brauninger holds an M.S. degree in Cellular, Microbial and Molecular Biology from George Mason University and is a member of the Society for Toxicology, AOAC International and the International Association for Food Protection (IAFP).

In this part of the series, we sit down with Brauninger to learn specific requirements in states, some of the benefits of using ISO/IEC 17025 and the influx of start-up or novice testing laboratories. Stay tuned for part three.

CannabisIndustryJournal: Do all states with legalized medical cannabis require the testing to be performed by an ISO/IEC 17025 accredited laboratory?

Roger Brauninger: No not at present, while most of the states where cannabis is legal do require accreditation; there are some states that have no requirements dealing with ensuring the competence of the testing laboratories, some that require the labs to be accredited to state environmental and drinking water standards, some that require laboratories adhere to Good Laboratory Practices (GLP) requirements and some have no requirements in place currently. Now, there are roughly 13 states that require or recommend accreditation of the testing laboratory to ISO/IEC 17025.

CIJ: If and when cannabis use is accepted federally, how is ISO/IEC 17025 accreditation of testing laboratories beneficial?

Roger: The accreditation process provides a uniform platform to allow for comparability of test results between states. This would also allow for these laboratories to benefit by being able to expand their customer base, if state borders were not an artificially imposed barrier to trade. This could also help to raise the quality of the testing services by allowing for greater participation in realistic accredited proficiency testing programs, which can create greater comparability of methods and results.

CIJ: What are the benefits to the states by choosing to require ISO/IEC 17025 accreditation as a basis for competence of testing laboratories?

Roger: States face the unique challenge, due to the federal illegality of cannabis, that they must craft their own regulatory cannabis program requirements. The ISO/IEC 17025 requirements provides a means upon which to recognize laboratory competence. This saves the states from having to come up with their own laboratory quality management requirements detailing the necessary activities a laboratory must address with respect to documentation, chain of custody, method validation, etc. Because these items are already considered in the standard. ISO/IEC 17025 helps to creates a baseline consistency amongst laboratories between states. And It also helps to   provides for the legal defensibility of the test results. If and when cannabis is legalized on a federal level, a uniform 50 state recognition is possible using ISO/IEC 17025 as the basis of recognition. In short accreditation can help to ensure that test results have greater comparability and reliability; It also provides greater trust and confidence in the labels and the stated ingredients.

CIJ: Many of the laboratories are “starting up”, how is A2LA equipped to deal with the influx of novice laboratories in this field of testing?

Roger: A2LA offers many different relevant training classes, including those on the ISO/IEC 17025 standard itself, (as well as ones that also contain cannabis-specific content), internal auditing, documenting your quality system, etc. for the laboratories. A2LA also is knowledgeable regarding various states’ cannabis regulatory requirements and can help guide the labs through some of the many obstacles they face in order to perform testing in their state.

CIJ: Does A2LA provide any technical assistance to laboratories that are starting up in this industry?

Roger: A2LA has numerous technical assessors who are experts in the analytical technology associated with cannabis testing. Assessors can be hired in a consulting role and act independently of the assessment process (and independent of A2LA). As a consultant, they can also assist in setting up a quality management system in compliance with ISO/IEC 17025.

CIJ: What benefits can be gained from a laboratory seeking accreditation or from a state that requires cannabis testing laboratories to be accredited?

Roger: Accreditation can provide legal defensibility and increased confidence in the test results being able to stand up in court.   It also may help to lower the cost of doing business because it helps to ensure that the test methods are in control by the laboratory and has been shown to be able to reduce the need for repeat testing. Laboratory accreditation has also led to reduced insurance rates in some cases.

Marijuana Matters

Education & Experience: Understanding the Operations

By David C. Kotler, Esq.
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I often write about the legal side of and opinions about the cannabis industry. Much of what I write about is culled from anecdotal experiences within either my personal practice or observations in regard to the industry. I recently had a trip to Portland, Oregon to spend time learning and understanding a little bit about a particular client’s operations so that I could provide counsel to that particular client, where permissible. For me, it was an important part of the education, which I stress and serve as the basis for this article.

With education comes understanding. What I see in the cannabis industry is often those who are critical of the use of cannabis, either recreationally or medically, seem to demonstrate some lack of understanding. In Florida, as the “No on Amendment 2″ commercials and videos roll out, I see much information that clearly comes from a lack of understanding or potentially a willful desire to distort the truth.

I share the following, less as a means to correct those distortions, but more as an opportunity to educate one who may be reading this and who may not have the same experience, which I just had the opportunity to receive. My time in Oregon was spent predominately in Portland and Salem as this is where the particular client has locations that I was able to view and experience.

My observation from a zoning perspective was that there was not a dispensary on every corner and that at times I had to be patient before seeing a dispensary during our drive. Of note in regard to the dispensaries that I did see was often the use of “cannabis” or “marijuana” in the name or associated with signage at the dispensaries, in addition to a green cross. However, there were many that did not take as visible an approach. I recall seeing, pursuant to the rules of the Oregon Program, windows covered so that one cannot see in. From time to time there were billboards advertising dispensaries. What I noticed most was in part, the clean presentation of the particular client I was seeing versus what was presented on the outside of many dispensaries we passed. This may be highlighted in part based on viewing dispensaries through what one might consider an East Coast lens. There are others that might argue that this perspective, particularly in emerging markets, is much different than that which has been developed over time in the West Coast markets, many of which have now gone recreational.

Overall, like anything, what I saw ranged the gamut from unprofessional and a little unsightly to professional and clean looking, which generally fit into the surrounding neighborhood. In particular, my client’s dispensary in Salem was in a retail shopping center along with a Little Caesars, Aaron’s Rentals, a nail salon, and other normal and expected retailers. Unless you poked your head inside the door, it would not be readily apparent that it was a dispensary.

My experience with the types and looks of the dispensaries running the gamut was mirrored by a particularly unique experience I had in viewing customers/patients. What was clear from a very limited time of viewing who it is that goes into a dispensary in Oregon was that it was impossible to pigeonhole the types of patients and ailments or, in the recreational setting, who the end user might be. On the Saturday morning of my visit, while viewing operations in Salem, I was approached and began to speak with an older gentleman with a long straggly gray beard who appeared to be in his late 60’s to early 70’s. During the course of our conversation he let me know that he is looking forward to taking it easy, and that he was a veteran. He had two friends with him and it looked like they were going to enjoy some time relaxing together, but he was also able to tell me that it was assistive to him at times when his anxiety got the best of him. His purchases were economical, and it was apparent that he and his friends were of limited socio-economic means; however, his purchases were notably and significantly cheaper for use than potentially alcohol if, in fact, he was not medicating and using with his friends recreationally.

Within minutes after the gentleman left, the exact opposite walked in the store. Candidly, I was mildly surprised by whom I held the door for to walk in as I was leaving. For a moment I was transported from Salem, Oregon to any town in central New Jersey or main street USA. Decked out in what could have been Lily Pulitzer or other preppy outfit were two soccer moms. They had stepped out of the newest model of a particular German automobile manufacturer. Unfortunately, I did not have the opportunity to engage with the soccer moms in discussion, but it was clear through their knowledge of the layout and interaction with the employee behind the counter that this was not their first trip to this particular location.

So what does the foregoing illustrate? For me it illustrates the development of perspective through education. It is that perspective that I hope to bring to the advice and counsel of clients. Perhaps I can use the knowledge to be assistive in making recommendations on regulatory issues, if consulted on them, helping to explain to politicians and bureaucrats or zoning and planning officials what might or might not be important in their considerations when dealing with a client. My observations should ultimately help me assist in educating others as to what the business and operation of cannabis related businesses might actually entail and look like. It is absolutely necessary, irrespective of one’s role in the cannabis industry, whether it be on the real estate side, insurance brokerage, providing legal or consulting advice (especially as individuals transition from those areas of practice in non-cannabis related spaces) that one take the time to understand the industry and its practice from the inside out. Only then can one be an effective resource to a cannabis related business wherein once the layers of the onion are peeled back, there is actually substance and information.