Protecting Consumer Health: The Need for More Stringent Lab Testing Rules
Milan Patel, CEO, PathogenDx
In this session, Milan Patel discusses:
The current problems with testing in the cannabis industry. (Loose regulation and enforcement, allowing operators without scruples to endanger consumers, E.G. increasing moisture to products to increase weight, while also increasing risk of mold.
Potential solutions to this problem. (Bring more attention to the problem, states need to follow CGMP for recreational markets, companies should test at every step of the supply chain)
Why this matters (beyond protecting consumers, this will help protect the reputation of the industry and individual companies within it.)
TechTalk: Millipore Sigma
Maria Nelson, Technical Consultant, AOAC International
Why Use an Accredited Laboratory to Test your Cannabis
Tracy Szerszen, President & Operations Manager, Perry Johnson Laboratory Accreditation (PJLA)
This presentation will educate listeners on the various aspects laboratories must meet in order to obtain ISO/IEC 17025 accreditation. This will include an overview of what the ISO/IEC 17025 standard mandates on laboratories, the accreditation process and timelines as well as best practices to become prepared for an assessment. Utilizing an accredited laboratory is critical to this market resulting in less retesting and reliable results to support safe products.
How Authenticity Testing Can Help Cannabis Businesses
Dr. Arun Krishnamurthy, NMR Spectroscopist, Purity-IQ
Hemp & Delta-8 in the United States: The Evolution of the Hemp Testing Market
Charles Deibel, President & CEO, Deibel Labs, Inc.
In this session, Charles Deibel discusses the current state of affairs across the country with respect to hemp testing. This includes a look at hemp testing rules at the state and federal level. He also provides an in-depth analysis on delta-8 THC and the controversy surrounding this cannabinoid, how to analyze samples of it and why the market has exploded around this product.
Kathleen May, Founder & Owner, Triskele Quality Solutions
This presentation discusses where the standard falls short, how poor lab practices may negatively impact the consumer and how poor or insufficient lab practices could result in regulatory action, including product recalls, fines, and loss of licenses.
Melanie Ross, Technical Products Developer, ANSI National Accreditation Board (ANAB)
TechTalk: Columbia Labs
Kelly O’Connor, Sales Director Key Accounts, Columbia Labs
Pesticides in Hemp: Challenges and Solutions
Grace Bandong, Business Unit Manger for Contaminants, Eurofins Food Chemistry Testing (EFCT)
This presentation takes a deep dive into understanding the requirements for pesticide testing, approaches to analysis and responding to regulatory requirements with extremely low LOQs.
TechTalk: Perkin Elmer
Tim Cooper, Sr. Manager, Software Development, PerkinElmer
This presentation provides an overview of how standards are developed and used, how Official Methods for cannabis are developed as well as training opportunities and proficiency testing.
What to Expect When Opening a Lab in a New State
Michael Kahn, Founder & CEO, MCR Labs
Kahn explores the lab’s role int he cannabis industry, the importance of knowing and understand state regulations and lessons for growing your lab while maintaining quality.
Heather Ebling, Manager of Applications and Support, Medicinal Genomics
In this session, Heather Ebling compares the differences between molecular and culture based microbial testing, explains the advantages and disadvantages of each method and guides attendees through how to evaluate the two different microbial testing methods.
TechTalk: What can qPCR do for your Laboratory?
Nick Lawson, Field Application Scientist, Medicinal Genomics
The Cannabis Laboratory Accreditation Panel
Tracy Szerszen, President & Operations Manager, Perry Johnson Laboratory Accreditation (PJLA)
This panel, moderated by CIJ editor Aaron Biros, goes in-depth into the new ISO/IEC 17025:2017 version, changes from the 2005 version, the new transition timeline mandated by ILAC, common challenges labs face when getting accredited and much more.
TechTalk: Your Results Are Only as Accurate as Your Reference Standard
Michael Hurst, Global Product Manager- Reference Materials, MilliporeSigma
TechTalk: Columbia Laboratories
Kelly O’Connor, Client Service Representative, Columbia Labs
Don’t Hold Your Breath: Smoke/Vapor Analysis & Quantifying Quality
Markus Roggen, Ph.D., Complex Biotech Discovery Ventures
Dr. Roggen details his method, sample prep and protocols for smoke and vapor analysis. He discusses the chemical changes that occur when cannabis products are burned or vaporized, how testing of aerosols and gasses are performed and what smoke tests can tell us and how they might better shape product development.
The event will begin every Tuesday at 12 pm ET, beginning on September 8 and continue through December 22. Each week will feature three educational presentations, two Tech Talks, and a panel discussion. Weekly episodes include cannabinoid research & discovery, cannabis labs, licensing applications, post-election analysis, the Canadian market, hemp quality, HACCP & GMPs, facility design, cultivation technology, safety & compliance, COVID-19’s impact and supply chain quality.
Roy Bingham, Co-Founder & CEO of BDSA, and Nic Easley, Founder and CEO of 3C Consulting , will serve as the keynote speakers on Tuesday, September 8, discussing cannabis market trends and COVID-19’s impact on the cannabis industry.
“Human connection is so important for events, and we know we’re not the only game in town. That’s why we’ve invested in a Conference Virtual Platform that can facilitate discussions, discovery, and connection that can continue whether our event is offline or online—and not end with the live streaming,” says Rick Biros, president of Innovative Publishing. “Simply, the experience other conferences are offering is not conducive to learning, staying engaged or take into consideration that you have a job to do during that week. This is why we have designed the Conference’s program with short, manageable episodes that are highly educational.”
Companies that are interested in sponsoring a 10-minute technical presentation during the series can also submit their abstract through the portal. For pricing information, contact IPC Sales Director RJ Palermo.
Innovative Publishing has also converted the Food Safety Consortium to a virtual event. More information is available at Food Safety Tech.
About Cannabis Industry Journal
Cannabis Industry Journal publishes news, technology, trends, regulations, and expert opinions on cannabis safety, quality, business and cannabis sustainability. We also offer educational, career advancement and networking opportunities to the global cannabis industry. This information exchange is facilitated through ePublishing, digital and live events.
Events across the globe have been postponed or canceled due to the coronavirus. COVID-19 is taking down many industries and leaving hundreds of thousands of people without jobs. At Innovative Publishing Company, our top priority is safety. In light of the recent travel restrictions and our concern over attendees’ safety, we have made the decision to convert our Cannabis Labs/Food Labs Conference to a virtual event. The event will no longer take place June 3–4. Instead, we are in the process of reorganizing the agenda to give our attendees the full benefit of sessions over a period of June 1–5. Recognizing the strain on the industry, this event will be free to attendees and underwritten by our sponsors. Check back soon here as we update the website and announce the new agenda for the virtual program. We look forward to seeing everyone virtually there.
Additionally, the Cannabis Quality Conference & Expo remains scheduled for October 21–23, 2020, however the Food Safety Consortium will now be postponed to December 2–4, 2020. More information on that can be found on Food Safety Tech. Innovative Publishing has developed a contingency plan in the event that COVID-19 continues to be a serious health concern throughout the fall season. This is very possible and we take these health concerns very seriously. That plan includes converting the conference to a virtual event, similar to our Cannabis Labs/Food Labs Conference.
A Message To Our Readers
If you have any questions or concerns, feel free to get in touch with us via the Contact Us page. Our editorial content in the newsletters and on the website will continue as usual, so check back regularly for news articles, features and columns as we continue to work remotely and provide you with educational content. We look forward to the upcoming virtual event and hope you’ll join us. We feel this is the smartest decision to make in the midst of the global pandemic. We hope our readers and their families remain safe and healthy. We’ll all get through this together.
EDGARTOWN, MA, Jan. 23, 2020 – Innovative Publishing Co., the publisher of Cannabis Industry Journal and organizer of the Cannabis Quality Conference & Expo is announcing the launch of the Cannabis Labs Conference. The event will address science, technology, regulatory compliance and quality management as they relate to the cannabis testing market. It will take place on June 2–3 at U.S. Pharmacopeia in Rockville, MD.
A few of the noteworthy topics that will be discussed at the conference include hemp testing under new federal guidelines, ISO 17025:2017 accreditation, potency and cannabinoid quantification, regulatory compliance and state regulations, microbiology and sample preparation best practices, among other topic areas.
The event is co-located with the Food Labs Conference, which will focus on regulatory, compliance and risk management issues that companies face in the area of testing and food laboratory management. More information about this event is available on Food Safety Tech. Some of the critical topics include a discussion of FDA’s proposed FSMA rule, Laboratory Accreditation Program for Food Testing; considerations in laboratory design; pathogen testing and detection; food fraud; advances in testing and lab technology; allergen testing, control and management; validation and proficiency testing; and much more.
“By presenting two industry conferences under one roof, we can provide attendees with technology, regulatory compliance and best practices that cannabis and food might share but also focused topics that are unique to cannabis or food laboratory industry needs,” said Rick Biros, president of Innovative Publishing Co., Inc. and director of the Food Labs Conference.
This column is devoted to helping cannabis analytical labs generate valid data right now with a relatively small amount of additional work. The topic for this article is instrument calibration – truly the foundation of all quality data. Calibration is the basis for all measurement, and it is absolutely necessary for quantitative cannabis analyses including potency, residual solvents, terpenes, and pesticides.
Just like a simple alarm clock, all analytical instruments – no matter how high-tech – will not function properly unless they are calibrated. When we set our alarm clock to 6AM, that alarm clock will sound reproducibly every 24 hours when it reads 6AM, but unless we set the correct current time on the clock based on some known reference, we can’t be sure when exactly the alarm will sound. Analytical instruments are the same. Unless we calibrate the instrument’s signal (the response) from the detector to a known amount of reference material, the instrument will not generate an accurate or valid result.
Without calibration, our result may be reproducible – just like in our alarm clock example – but the result will have no meaning unless the result is calibrated against a known reference. Every instrument that makes a quantitative measurement must be calibrated in order for that measurement to be valid. Luckily, the principle for calibration of chromatographic instruments is the same regardless of detector or technique (GC or LC).
Before we get into the details, I would like to introduce one key concept:
Every calibration curve for chromatographic analyses is expressed in terms of response and concentration. For every detector the relationship between analyte (e.g. a compound we’re analyzing) concentration and response is expressible mathematically – often a linear relationship.
Now that we’ve introduced the key concept behind calibration, let’s talk about the two most common and applicable calibration options.
Single Point Calibration
This is the simplest calibration option. Essentially, we run one known reference concentration (the calibrator) and calculate our sample concentrations based on this single point. Using this method, our curve is defined by two points: our single reference point, and zero. That gives us a nice, straight line defining the relationship between our instrument response and our analyte concentration all the way from zero to infinity. If only things were this easy. There are two fatal flaws of single point calibrations:
We assume a linear detector response across all possible concentrations
We assume at any concentration greater than zero, our response will be greater than zero
Assumption #1 is never true, and assumption #2 is rarely true. Generally, single point calibration curves are used to conduct pass/fail tests where there is a maximum limit for analytes (i.e. residual solvents or pesticide screening). Usually, quantitative values are not reported based on single point calibrations. Instead, reports are generated in relation to our calibrator, which is prepared at a known concentration relating to a regulatory limit, or the instrument’s LOD. Using this calibration method, we can accurately report that the sample contains less than or greater than the regulatory limit of an analyte, but we cannot report exactly how much of the analyte is present. So how can we extend the accuracy range of a calibration curve in order to report quantitative values? The answer to this question brings us to the other common type of calibration curve.
A multi-point calibration curve is the most common type used for quantitative analyses (e.g. analyses where we report a number). This type of curve contains several calibrators (at least 3) prepared over a range of concentrations. This gives us a calibration curve (sometimes a line) defined by several known references, which more accurately expresses the response/concentration relationship of our detector for that analyte. When preparing a multi-point calibration curve, we must be sure to bracket the expected concentration range of our analytes of interest, because once our sample response values move outside the calibration range, the results calculated from the curve are not generally considered quantitative.
The figure below illustrates both kinds of calibration curves, as well as their usable accuracy range:
This article provides an overview of the two most commonly used types of calibration curves, and discusses how they can be appropriately used to report data. There are two other important topics that were not covered in this article concerning calibration curves: 1) how can we tell whether or not our calibration curve is ‘good’ and 2) calibrations aren’t permanent – instruments must be periodically re-calibrated. In my next article, I’ll cover these two topics to round out our general discussion of calibration – the basis for all measurement. If you have any questions about this article or would like further details on the topic presented here, please feel free to contact me at firstname.lastname@example.org.
The Oregon Health Authority (OHA) recently implemented a set of temporary rules effective through June 28th of this year with the goal to establish a set of regulations for cannabis testing by October 1st. An investigation by The Oregonian highlighted some of the previous problems with cannabis testing in the state.
The most impactful rule changes include The NELAC Institute (TNI) mandatory standards for laboratories that the Oregon Environmental Laboratory Accreditation Program (ORELAP) will use to accredit labs. Initial rules in the Oregon medical cannabis program, HB 3460 from 2013, did not specify accreditation rules for cannabis testing.
ORELAP currently performs accreditation for lab testing under the Clean Air Act, Clean Water Act, Resource Conservation and Recovery Act and the Safe Drinking Water Act. The new cannabis testing rules will give ORELAP the authority to accredit and regulate cannabis labs in the state of Oregon.
Rodger Voelker, Ph.D., laboratory director of OG Analytical in Eugene, OR, believes these rules are monumental in establishing legitimacy in cannabis testing. “These new rules have major repercussions mainly because they require not only getting accreditation, but maintaining it with very strict requirements,” says Voelker. “That also includes procedural guidelines that very carefully outline the quality of laboratory practices and establishes a set of criteria for method validation.”
Voelker notes that two of the biggest changes are in quality control and data management. “The documentation they require is very thorough and strict with the idea that any aspect of an analysis can be replicated,” adds Voelker. “This is a real win for us in my opinion because now we have an agency that can issue the appropriate credentials as well as have the authority to make punitive measures.”
The timeline for implementation with temporary rules allows state regulators to work with laboratories to perform accreditation and bring laboratories up to speed. According to Shannon Swantek, ORELAP compliance specialist, products that dispensaries sell in medical and recreational markets are required to be tested under the new rules and in the analyte lists by an ORELAP accredited laboratory, starting on October 1st.
Swantek’s job is to accredit cannabis labs to the TNI standards, which is essentially very similar to ISO 17025, just with more prescriptive measures and the ability to pair with state agencies to enforce rules after accreditation. “The timeline for accreditation is dependent on how ready the lab is and how compliant they are to the TNI standard already,” says Swantek. “The culture had gotten so fraudulent that the legislature felt Oregon needed some serious, more strict rules in place.”
One of the biggest changes coming to Oregon cannabis testing is the new sampling requirement. “An accredited laboratory employee must take the sample because sampling is where a lack of training or outright fraud is skewing results, which occurs when a grower brings in a sample not representative of the batch,” adds Swantek. Sample preparation methods will also be required to be more robust to meet the action limits of pesticide testing in particular, helping to identify lower levels like parts-per-billion, according to Swantek.
Reports were also lacking key information in the past. The new rules will require more information such as the procedure used, the analyst carrying it out, dilution factors and any other information you need to theoretically reproduce the result. This will result in more accurate labels on products.
Many are concerned that the new lab testing requirements will raise the price of testing too much. In reality, those current prices are not realistic for accurate data, which points to the rampant fraud that ORELAP is trying to eradicate. “The old rules were written in such an ambiguous way that the prices were set by laboratories without a proper quality program or even without proper instrumentation,” says Swantek.
The accreditation process will require particularly robust quality control systems in labs. “Accreditation to the TNI Standard means that lab quality systems will require a documentation system, training procedures, record keeping, personnel requirements, organization details, proof of no conflicts of interest and corrective actions if noncompliant,” adds Swantek. “We single out each method or procedure, look at their raw data and proficiency testing and determine if they are meeting the technical requirements.”
According to Voelker, other industries have learned to adjust their costs with stringent lab testing rules. “I get that no one wants to pay more for lab testing, but the reality is that joining the world of commodities comes with additional costs to ensure consumer safety,” says Voelker. These rule changes will undoubtedly bring more consistency to Oregon’s cannabis industry with accurate lab testing and help the OHA shed more light on issues surrounding consumer safety.
Nic Easley, chief executive officer at Comprehensive Cannabis Consulting (3C), delivered the keynote address at the first annual Cannabis Labs Conference, co-located with Pittcon. Easley begins with a discussion of the 2014 milestone where Colorado and Washington legalized recreational cannabis, opening the floodgates for a diverse range of products and business opportunities in quality and safety testing. With members of his team sitting on the Colorado Department of Agriculture’s Pesticide working group, they are working with industry leaders and regulators to comprehensively write the standards. “The industry gets regulated in 2014 in Colorado with a total of $2.7 billion in sales in the first year of the industry’s history,” says Easley. “We have this giant influx of business, but without process validation, good agricultural practices and proper SOPs, each state is left to fend for themselves to write regulations.”
Nic Easley, chief executive officer at Comprehensive Cannabis Consulting (3C), delivered the keynote address at the first annual Cannabis Labs Conference, co-located with Pittcon. Easley set the tone of the conference early on by identifying safety and quality concerns in the current cannabis marketplace. “We can choose to do business as usual or we can create a new model with outside industry expertise to help guide this industry forward responsibly,” says Easley. Noting the existing comprehensive standards in food and agriculture, Easley emphasized the value of the Cannabis Labs Conference in bringing that expertise to the cannabis space. “We have the guidance and expertise in this room alone to help move the cannabis industry forward out of the closet and into the sunlight,” adds Easley.
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