According to a press release published on April 3, Keystone State Testing (doing business as Dakota State Testing) became the first laboratory authorized to test cannabis in North Dakota. The lab also obtained their ISO 17025 accreditation for cannabis testing from the American Association of Laboratory Accreditation (A2LA), which is another first achievement for cannabis testing in the state of North Dakota.
Dr. Kelly Greenland, chief science officer at Keystone State Testing, says the North Dakota Department of Health set a high standard for the cannabis lab testing industry in the state. “Keystone State Testing is once again proud to of this monumental achievement and critical milestone in the company’s history to have met the highest levels of standards set forth by both A2LA and the North Dakota Department of Health,” says Greenland. “Keystone chose A2LA as its Accreditation Body due to their reputation in the industry, their diverse clientele, and the quality of their assessors. A2LA’s assessors have spent decades in their respective fields, which helps to ensure that Keystone is providing the best services possible to their clients, regulators and patients.”
Keystone State Testing’s ISO 17025 accreditation scope covers 11 testing methods at their facility in Fargo, North Dakota. Those methods include: Cannabinoid potency analysis, cannabinoid profile, moisture content, residual solvents, water activity, along with microbiological tests like total yeast and mold count, E. coli, Salmonella, total aerobic microbial count, among others.
EVIO Labs Florida received their ISO 17025:2005 accreditation in February of 2018. Last week, EVIO Labs Florida announced via a press release that they completed their ISO 17025:2017 accreditation and received a certification from AOAC International. The accreditation helped them to further expand their testing scope to shelf life and stability testing, the ability to detect harmful bacteria and calculate degradation in samples.
The certification that they received from AOAC helps verify their ability to conduct accurate and fair 3rd party testing, meeting Florida’s requirements for the market. Back when the laboratory first started in 2017, there were no requirements for lab testing cannabis products under Florida’s regulations.
Upon expanding to their Gainesville location in November last year and getting accredited to ISO 17025:2017 last week, EVIO Labs Florida expects the new location to be compliant and operational by April 2019, in preparation for the state’s new regulations. “Our team has worked diligently to maintain our stance as the Gold Standard in Cannabis Testing,” says Chris Martinez, co-founder and president of EVIO Lab Florida. “The ability to obtain the recent ISO 17025:2017 and AOAC certification is a testament to our dedication in maintaining public safety and product integrity in an ever-growing industry.”
Martinez is also presenting during the 2ndAnnual Cannabis Labs Virtual Conference on April 2, where he will discuss how EVIO Labs Florida began as a laboratory and how they were able to expand to a second location and grow their market presence in Florida. Click here to register for his talk.
The 2ndAnnual Cannabis Labs Virtual Conference is set to take place on Tuesday, April 2, 2019, starting at 12:00 Noon and concluding at 4:00 PM EDT. This complimentary series of webinars will take a deep dive into a variety of subjects related to cannabis testing and the laboratory industry.
The virtual event will help attendees better understand some of the more technical aspects of starting and operating a laboratory. Topics discussed will include pesticide testing, cannabinoid and terpene testing, the new ISO 17025:2017 accreditation and a lesson in starting a laboratory in a new market.
Attendees registering for this complimentary series of webinars will get access to four veterans of the cannabis lab testing industry, who are available for Q&A after each presentation. In addition to getting the opportunity to chat with these subject matter experts on April 2, a recording of the presentations will be made available to all who register.
Here is a snapshot of the agenda:
Pesticide Testing: Methods, Strategies & Sampling Charles Deibel, President & CEO – Deibel Labs, Inc.
Pesticides represent the number one area for batch failures in the US cannabis market. These are concerns not only for consumers, but are a very big concern for cultivators and manufacturers of cannabis products. remediation of the pesticides, once they are in the product are not always feasible From the lab level, they are also the hardest test to run in the laboratory, even one equipped with state-of-the-art equipment. The best instruments on the market are very expensive and there are no standardized methods, meaning lab to lab variability has happened.
What are the pesticides in cannabis and are there any that are the “main concerns” or ones that stand out as particularly damaging?
What is a basic breakdown of the testing and methods used for pesticide testing?
What are the best strategies for the sampling of cannabis products?
Building a Lab in an Emerging Market Chris Martinez, Co-Founder & President, EVIO Labs FL
Will present a discussion of the genesis of EVIO Labs Florida, how to start a lab in a new market
Challenges in how we navigated changing regulations in a state with newly legalized cannabis
Expanding a lab to a second location – logistics, hiring, training, consistency.
Dr. Cindy Orser, Chief Science Officer, Digipath Labs
Appreciation of “measurement uncertainty” in cannabis testing
Standardization of testing methods is a high priority
Terpenes are the distinguishing chemicals in cannabis sensory perception and chemotaxonomy
Benefits of Accreditation to the ISO 17025:2017 Standard Jane Weitzel, Independent Consultant
The ISO/IEC 17025:2017 standard is now being used to accredit cannabis testing laboratories. From this presentation you will learn the key new aspects of the standard. This includes risk-based thinking. Many aspects of this risk approach require the use of measurement uncertainty. This means the measurement uncertainty must be adequately evaluated. You will be introduced to evaluating and using measurement uncertainty.
The 2017 standard emphasizes conflict of interest and impartiality. Procedures and practices to achieve impartiality will be shown. This reduces the risk of potentially damaging leaks of information or the risk of people not working to the best interests of the laboratory and its clients.
The 2017 standard is a valuable and useful business tool that can save the laboratory resources, effort and money. Are you doing too much testing? Are you doing too little testing? When you evaluate the measurement uncertainty you can use it to learn the steps in your test method that need enhancement to reduce the risk of making mistakes. You can also use the measurement uncertainty to focus on the significant steps and stop wasting time on steps and activities that are insignificant.
These benefits of laboratory accreditation will be demonstrated with examples from the cannabis industry.
Phenova, Inc., a proficiency testing products and reference materials provider based in Golden, Colorado, works with labs and regulatory bodies to develop proficiency testing (PT) programs. According to a press release sent out by the American Association for Laboratory Accreditation (A2LA), Phenova is A2LA’s first ISO/IEC 17043 accredited PT provider for the cannabis marketplace.
According to Ty Garber, director of new business development for the cannabis and food and beverage markets at Phenova, they have been working with A2LA for over a decade in other industries, but the cannabis testing industry is a huge new market for them. “Our Cannabis Proficiency Testing products and services are experiencing high demand across North America and we are fortunate to offer our expertise in proficiency testing to client laboratories and regulatory agencies in their joint efforts to ensure cannabis product quality and safety,” says Garber. “By working with the laboratories and stakeholder agencies, we have been able to develop and operate Proficiency Testing Programs based on real marijuana matrices, especially where the matrix creates specific analytical challenges. This approach has proven to be very beneficial for everyone involved, and we are working diligently to expand these efforts.”
Trace McInturff, senior director of accreditation services at A2LA, says this could help fill a serious need for conformity assessments in accredited cannabis labs. “A2LA is excited to announce the expansion of Phenova’s existing ISO/IEC 17043 Proficiency Testing Provider scope of accreditation to become the first A2LA accredited Proficiency Testing Provider for cannabis,” says McInturff. “This milestone adds to the positive historical relationship between Phenova and A2LA that dates back to 2005 when A2LA implemented a new TNI SSAS program for Proficiency Testing Providers and A2LA performed one of the first assessments of its kind at Phenova.” McInturff also says that A2LA has been instrumental in establishing the initial ILAC Proficiency Testing Provider accreditation requirements which ultimately became the basis for ISO/IEC 17043.
In addition to the “real marijuana matrix PT programs” that Phenova offers in certain states and countries where legal, they also offer alternative PT standards for labs that have obtained or are working on obtaining ISO/IEC 17025 accreditation.
At this year’s Food Safety Consortium a couple weeks ago, the newly launched Cannabis Quality Track featured a number of panels and presentations that highlighted the many intersections between food safety and cannabis. One particular topic of interest was measuring the quality and safety of cannabis products through laboratory testing. At the event this year, representatives from the leading laboratory accreditation bodies in the country sat together on a panel titled Accreditation, Regulation & Certification: Cannabis Labs and Production.
Chris Gunning, life sciences accreditation manager with A2LA
The new ISO 17025:2017 standard was a topic addressed pretty early in the panel. Tracy Szerszen introduced the topic with a recap of the 2005 standard. “With 17025, for those that are familiar with the older version, 2005, there are really two sections of the standard for that one,” says Szerszen. “The newer standard is a little bit different, but there is a quality management system review that we do and we look at the laboratory to ensure that they are testing appropriately based on what they applied for. So, for cannabis labs, they typically have the same scope in types of methods with respect to microbiology and chemistry, and we are making sure they are following the standard from a technical standpoint, meaning they have the right equipment, the appropriate personnel and also have a quality management system.”
Chris Gunning followed that up with a closer look at the changes coming to the new 2017 standard. “If you are familiar with the 2005 version, you know that a lot of the clauses started out with a ‘you shall have a policy and procedure for doing X,’” says Gunning. “One of the major changes to the 2017 version is it gives laboratories more latitude on whether they need to have a policy/procedure to do certain things.” Gunning says the 2017 version is much more of an outcome-based standard. “As far as assessing to it, it becomes a little harder from our side because we can’t say you have to have this quality manual or you have to have this procedure that were going to assess you to. We are more open to looking at the outcomes.”
The most interesting change to the ISO standard comes with addressing the idea of risk. “One of the newest concepts in this standard is risk and how you assess your risk to your organization how you assess risk of impartiality, how you assess your measurement uncertainty when you are creating decision rules,” says Gunning. “Those are the big concepts that have changed in the 2017 standard in that it is more outcome-based and introducing the concept of risk more.”
After discussing some of the broader changes coming to the 2017 version, the panelists began delving into some common pitfalls and issues labs face when trying to get accredited. “From our experience, in Michigan, the new standard was written into the regulations, but a lot of labs were already accredited to 2005,” says Szerszen. “So, we actually contacted the state and explained to them that they have three years to transition. And some states will say ‘too bad, we want the 2017 ISO,’ so some of the cannabis labs are asking us to quickly come back so they can get appropriate licensing in the state and do a transition audit quickly.” She says most states seem to be comfortable with the current transition period everyone has, but it certainly requires some discussion and explanation to get on the same page with state regulators. “November 29, 2020 is the deadline for moving to the new 2017 standard.”
In addition to state requirements like traceability and security on top of an ISO 17025 accreditation, labs can run into issues not typically encountered in other testing markets, as Gunning mentioned during the panel. “One of the hardest parts of getting accredited is the need for properly validated methods, for all the different matrices in samples,” says Gunning. “Some of the biggest hurdles for new labs getting assessed are validation and the availability of reference materials and proficiency testing samples that meet their state requirements.” Those are just a handful of hurdles that labs aren’t usually anticipating when getting accredited.
Another big topic that generated a lot of dialogue during the panel was the need for a national accreditation standard for cannabis testing labs, one that Natalia Larrimer is advocating for. “Many laboratories are operating facilities in more than one state and what they are facing is a different set of criteria for laboratory recognition in each state, says Larrimer. “One initiative that we would love to see more support for, is a set of uniform requirements nationally. ACIL is currently working on developing these type of requirements which would be in addition to the ISO/IEC 17025 standard and specific for cannabis industry…” Larrimer says she’d like to see these requirements recognized nationally to get labs on the same page across multiple states. “This includes requirements for things like security, traceability, proficiency testing, sampling and personnel competence. The industry would greatly benefit from a uniform cannabis testing program across the US, so that testing facilities in Oregon are operating to the same criteria as facilities in California or Colorado, etc.”
The panelists went into greater detail on issues facing the cannabis lab testing industry, but also delved into certifications for food safety and quality, an important new development as the infused products market grows tremendously. Stay tuned for more highlights from this panel and other talks from the Food Safety Consortium. We will be following up this article with another that’ll shed some light on food safety certifications. Stay tuned for more!
According to a press release sent out this morning, the American Association for Laboratory Accreditation (A2LA) accredited their first Pennsylvania cannabis-testing laboratory. Located in Harrisburg, PA, Keystone State Testing finalized their accreditation for ISO/IEC 17025 on February 21, 2018.
A2LA also accredited the laboratory to two cannabis-testing-specific programs, ISO/IEC 17025 – General Requirements for the Competence of Testing and Calibration Laboratories and A2LA R243 – Specific Requirements – Cannabis Testing Laboratory Accreditation Program. The R243 program is a collaboration with Americans for Safe Access (ASA) that takes some recommendation for regulators from the American Herbal Products Association (AHPA).
Keystone State Testing is now able to perform all of the tests for cannabis products under the state of Pennsylvania’s regulations. According to Dr. Kelly Greenland, owner and operator of Keystone State Testing, getting accredited is about safeguarding patient safety. “Keystone State Testing is proud to be the first Pennsylvania laboratory to earn A2LA ISO/IEC 17025 accreditation as well as ASA’s Patient Focused Certification,” says Dr. Greenland. “We regard these accreditations and certifications as the first steps in ensuring patient safety and will continue to do everything within our power to ensure medical marijuana patient safety.”
A2LA General Manager Adam Gouker says he wants to see more accreditations include the ASA requirements in R243. “A2LA is pleased to see the growing adoption of the combined assessment to include the ASA requirements,” says Gouker. “Our staff has worked tirelessly in conjunction with ASA staff to create this combined program and offer something that no other accreditation body in the world offers. We congratulate Keystone State Testing Labs on leading the charge in the state of Pennsylvania and laying the groundwork for future laboratories to follow.”
The lab was accredited to ISO/IEC 17025 – General Requirements for the Competence of Testing and Calibration Laboratories, so they are now able to test for pesticides in cannabis and other matrices, according to the press release published today. “WSDA sought this accreditation to ensure our clients can have absolute confidence in our testing methods and lab results. The information we produce drives enforcement cases and policy decisions,” says Mike Firman, manager of the WSDA Chemical and Hop Laboratory. “We want to do everything that can be done to make sure our data is reliable.”
The A2LA Cannabis Accreditation Program is essentially a set of standards for quality in testing cannabis and cannabis-based products, such as infused products, tinctures and concentrates. ISO 17025 accreditation is quickly become a desirable certification for laboratories. Many states strongly encourage or even require ISO 17025 accreditation for cannabis laboratories. California recently released a set of proposed lab testing regulations for the cannabis industry that specifically requires an ISO 17025 accreditation in order for laboratories to issue certificates of analysis.
Because each state’s requirements for laboratories testing cannabis varies so greatly, A2LA works with state regulators to craft their accreditation program to meet each state’s specific requirements. “A2LA is excited to play such an important role in the accreditation of cannabis testing laboratories and is pleased to see ISO/IEC 17025 accreditation expanding into additional states,” says A2LA General Manager Adam Gouker. “Priority must be placed on ensuring that cannabis products are tested by competent laboratories to convey confidence in the results – a cornerstone which underpins the safety to all end-users.” A2LA is currently accepting applications for cannabis laboratories working to receive accreditation. Labs that already have ISO 17025 accreditation and are in a state with legal cannabis, have the ability to expand their scope of accreditation if they are looking to get into cannabis testing.
Formerly named the Bureau of Medical Cannabis Regulation under the state’s Department of Consumer Affairs, the Bureau of Marijuana Control is tasked with overseeing the development, implementation and enforcement of the regulations for the state’s cannabis industry. In their statement of reasons for the lab testing regulations, the bureau says they are designed with public health and safety at top of mind. At first glance, much of these laboratory rules seem loosely modeled off of Colorado and Oregon’s already implemented testing regulations.
The regulations lay out requirements for testing cannabis products prior to bringing them to market. That includes testing for residual solvents and processing chemicals, microbiological contaminants, mycotoxins, foreign materials, heavy metals, pesticides, homogeneity as well as potency in quantifying cannabinoids.
The microbiological impurities section lays out some testing requirements designed to prevent food-borne illness. Labs are required to test for E. coli, Salmonella and multiple species of the pathogenic Aspergillus. If a lab detects any of those contaminants, that batch of cannabis or cannabis products would then fail the test and could not be sold to consumers. A lab must report all of that information on a certificate of analysis, according to the text of the regulations.
The proposed regulations stipulate requirements for sampling, including requiring labs to develop sampling plans with standard operating procedures (SOPs) and requiring a lab-approved sampler to follow chain-of-custody protocols. The rules also propose requiring SOPs for analytical methodology. That includes some method development parameters like the list of analytes and applicable matrices. It also says all testing methods need to be validated and labs need to incorporate guidelines from the FDA’s Bacterial Analytical Manual, the U.S. Pharmacopeia and AOAC’s Official Methods of Analysis for Contaminant Testing, or other scientifically valid testing methodology.
Labs will be required to be ISO 17025-accredited in order to perform routine cannabis testing. Laboratories also need to participate in proficiency testing (PT) program “provided by an ISO 17043 accredited proficiency-test provider.” If a laboratory fails to participate in the PT program or fails to pass to receive a passing grade, that lab may be subject to disciplinary action against the lab’s license. Labs need to have corrective action plans in place if they fail to get a passing grade for any portion of the PT program.
On December 7th, 374 Labs received ISO 17025 accreditation, becoming the first in Nevada to do so. The laboratory, based in Sparks, Nevada, is state-certified and now the only ISO 17025 accredited lab in the state, according to a press release. The laboratory is a member in both the Association of Commercial Cannabis Laboratories (ACCL) and the Nevada Cannabis Laboratory Association (NVCLA).
According to the release, 374 Labs was a driving force behind Nevada’s round robin cannabis lab testing program. That program, administered by the Nevada Division of Public and Behavioral Health (DPBH) and the Nevada Department of Agriculture (NDA), sends cannabis samples to each state-certified cannabis lab for a full analysis, measuring the consistency in test results across labs. “In other states proficiency involves testing pre-prepared, purified samples and neglects the challenges of coaxing out delicate analytes from the complex array of compounds found in actual marijuana,” says Laboratory Director Jason Strull. “I commend the DPBH and NDA for facilitating such an advanced quality program.”
Also notable is the announcing of their partnership with Clean Green Certified, a third-party certification (based on USDA organic certification) for sustainable, organically based cannabis cultivation. “Nevada allows certain levels of pesticides like Myclobutanil on its certified marijuana, so we wanted a way for patients and consumers to able to distinguish marijuana that is grown using organic methods,” said Laboratory Director Jason Strull. According to Michael Seibert, managing member of 374 Labs, they have already started performing inspections for the third-party certification and the first facility inspected was Silver State Trading in Sparks, Nevada (certified for both production and cultivation).
“By achieving ISO/IEC 17025 accreditation, TEQ Analytical Labs believes that we can address the concerns throughout the cannabis industry regarding insufficient and unreliable scientific analysis by providing our clients with state-required tests that are accredited by an international standard,” says Seth Wong, president of TEQ Analytical Laboratories. According to a TEQ Analytical press release, accreditation to this standard confirms that laboratories have the management, quality, and technical systems in place to ensure accurate and reliable analyses, as well as proper administrative processes to confirm that all aspects related to the sample, analysis and reporting are standardized, measured and monitored.
By implementing ISO 17025 accreditation, the laboratory monitors systems and processes central to analyses in an effort to minimize discrepancies and variability in test results. According to Roger Brauninger, biosafety program manager at A2LA, this type of accreditation demonstrates their competence and commitment to rigorous science. “It is encouraging to have testing laboratories taking ownership of the quality of the work performed,” says Brauninger. “Reliable testing will be imperative to insure safety of the products out on the market as this industry continues to expand.” As the first accreditation of its kind in North America, Brauninger hopes this will open the doors for more cannabis laboratories to acknowledge their role in demonstrating scientific competency for the industry.
Tripp Keber, president and chief executive officer of Dixie Brands, Inc., commends the achievement. “At Dixie Brands, we believe that cannabis is powerful, that quality is important, and that accurate dosing is of supreme importance,” says Keber. “Because Dixie is committed to delivering a safe, consistent, and accurately dosed product, lab testing is a vital component to our manufacturing processes.”
“TEQ’s achievement of ISO 17025 accreditation instills great confidence to Dixie Brands that our consumers’ health and safety is ensured and that they will enjoy a reliable and predictable experience with our product each and every time,” adds Keber. “Dixie’s strategic relationship with TEQ continues to build long-term brand value.” This kind of accreditation helps build trust in laboratories’ clients knowing they can provide accurate results repeatedly.
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