The American Association for Laboratory Accreditation (A2LA) published a press release yesterday announcing the accreditation of Green Leaf Laboratory, a cannabis testing lab based in Portland, Oregon. According to that press release, they are the first cannabis testing lab in the state of Oregon to achieve the ISO 17025:2017 accreditation.
Rowshan Reordan, founder of Green Leaf Laboratory, says they have been a leader in the cannabis market since for more than nine years, since their launch in 2011. “Receiving our ISO/IEC 17025 accreditation, in addition to required state accreditation, affirms our commitment to quality science and leadership in this industry,” says Reordan. “Working with A2LA and being recognized as the first A2LA accredited laboratory in Oregon has been a great experience. We appreciated the thoroughness in their accreditation process and their commitment to excellence. We look forward to a successful future with A2LA and continuing our commitment to leadership and excellence in the industry.”
“We congratulate Green Leaf Laboratories on becoming the first cannabis testing laboratory accredited to ISO/IEC 17025:2017 in the state of Oregon”, says Anna Williams, Accreditation Supervisor at A2LA. “A2LA is excited to see testing laboratories think outside of the box and elect to use our services in states not mandating them.”
According to a press release, the ANSI National Accreditation Board (ANAB) accredited Pure Labs, LLC to ISO/IEC 17025. The Phoenix, Arizona-based laboratory achieved the accreditation after demonstrating the ability to meet general requirements for the competence of testing labs.
The press release says that Pure Labs is one of the first cannabis testing labs in Arizona to achieve the ISO/IEC 17025 accreditation. According to R. Douglas Leonard, vice president of ANAB, they have seen a rise in demand for labs across the country. “Demand for competent testing laboratories is growing as many states have legalized medical and adult-use recreational marijuana,” says Leonard. “Testing by a laboratory accredited to ISO/IEC 17025 is necessary to demonstrate that cannabis products are safe for consumption and free from harmful levels of contaminants.”
Barbara Dow, CEO of Pure Labs, LLC, believes their scope of accreditation is the best in their state. “The ANSI National Accreditation Board welcomed us and our scope of accreditation, which is the most comprehensive scope in Arizona,” says Dow. “I am proud of our team and our success as one of the first ISO/IEC 17025 accredited laboratories in our state. This level of excellence was made possible by ANAB, our accreditation partner. It is an exciting time for our laboratory in this fast-paced industry.”
In a press release published on Monday, the American Association for Laboratory Accreditation (A2LA), announced the renewal of accreditation for Global Laboratory Services, Inc. for ISO 17025:2017 in cannabis testing. The laboratory, based in Wilson, North Carolina, becomes first cannabis testing laboratory accredited in that state by adding the industrial hemp testing to their chemical scope of accreditation.
According to Kim Hesse, business development manager at Global Laboratory Services, they plan to expand their services in the hemp market with additional types of hemp testing. “At Global Laboratory Services, we always strive to keep pace with industry needs,” says Hesse. “We saw the need for an accredited laboratory in the hemp industry and therefore added CBD and THC testing to our scope. Our next step is to expand our service offerings to include agrochemical analysis of industrial hemp.”
Adam Gouker, general manager at A2LA, says accreditation plays a vital role in the cannabis industry and its regulatory requirements. “We congratulate Global Laboratory Services on becoming the first cannabis testing laboratory accredited in the state of North Carolina, specifically for industrial hemp,” says Gouker. “A2LA realizes the vital role that accreditation plays in the cannabis industry to support compliance with regulatory requirements, and we are thrilled to see that our service has been adopted in a new state. We look forward to our continued relationship with Global Laboratory Services in the provision of their accreditation needs.”
Encore Labs is a full-service cannabis testing lab in Pasadena, California, providing all testing needs required by California’s Bureau of Cannabis Control (BCC). The BCC requires that cannabis products being sold in licensed dispensaries be tested for cannabinoid potency, heavy metals, microbial impurities, moisture content and water activity, mycotoxins, residual pesticides, residual solvents and processing chemicals, foreign materials and terpenes. It is Encore Labs’ goal to guarantee the quality and potency of all cannabis products while ensuring regulatory guidelines are met in the state of California.
Encore Labs provides quick turnaround times on a consistent basis. They take pride in offering excellent customer service without diminishing the quality of the work that they do. Their team of laboratory analysts/technicians are passionate about the industry and will never compromise their integrity just to make an extra buck.
Co-Founder, Spencer Wong, mentions their personal connection with clients. “Our customers don’t just see us as their testing laboratory, they see Encore Labs as their laboratory partner,” says Wong. “Besides performing analytical testing, we have worked with many customers to help formulate new products and do root cause analysis to pinpoint inefficiencies in their manufacturing operations and cultivation farms.”
ISO/IEC 17025 Accreditation has been extremely valuable to Encore Labs, especially regarding the new cannabis testing industry. “Our experience with Perry Johnson Laboratory Accreditation, Inc. has been great and has allowed for a very smooth and straightforward initial accreditation process. Their staff has been knowledgeable and responsive every step of the way,” says Wong.
Accreditation establishes that steps are being taken regarding quality and that laboratories are meeting and exceeding the highest testing standards. It also provides further assurance and confidence in data results as well as validated methods, staff training procedures, equipment calibration and successful participation in proficiency testing/interlaboratory comparisons.
Starting out with 1500 square feet of laboratory space, within the last year Encore Labs has doubled its work area. In order to meet the growing demand of the cannabis testing industry, they have added plans to once again double in size by the end of 2019, as well as open a second laboratory by the end of 2020.
According to a press release published earlier this week, A2LA announced the accreditation of two separate cannabis laboratories in two separate states; both are the first cannabis testing labs accredited in their states. Demeter Laboratory, based in Oklahoma City, Oklahoma, and Galbraith Laboratories, based in Knoxville, Tennessee, achieved the ISO 17025:2017 accreditation.
According to Cassy VanTassel, M.S., quality manager at Demeter Laboratory, Oklahoma is still developing and defining their regulatory framework for cannabis testing requirements. “Even though the State of Oklahoma is still establishing regulations and legislation, Demeter will always strive to meet the highest quality standards, so our customers know they are getting the best quality testing,” says VanTassel. “Demeter chose A2LA as its Accreditation Body due to their reputation in the industry, their diverse clientele, and the quality of their assessors.”
In Tennessee, Galbraith Labs is looking to aid the hemp industry in product safety testing. Christy Myers, customer service manager at Galbraith Laboratories, says they want to help farmers produce safe hemp products. “We are proud of our commitment to stay current within our industry and achieve the high standards set by A2LA,” says Myers. “Adding cannabis testing to our line of services was a great opportunity for Galbraith Laboratories to serve the community by helping farmers produce safe and legal hemp.”
Galbraith Labs was founded in 1950 as a contract lab in Knoxville serving many industries. With their newly established accreditation, they hope to aid the cannabis industry in Tennessee with hemp testing. Demeter Laboratory is the first medical cannabis lab in Oklahoma. Their goals include “advancing quality controls in medical cannabis, supporting safe consumption of cannabis and ensuring the transparency of the cannabis community.”
According to a press release issued last week, the American Association for Laboratory Accreditation (A2LA) accredited Legend Technical Services to ISO/IEC 17025:2005 for industrial hemp testing. Legend Technical Services, based in St. Paul, Minnesota, is currently the only accredited cannabis testing in the state.
The lab is now accredited for medical cannabis testing as well as all industrial hemp testing for the Minnesota Department of Agriculture. Trace McInturff, Vice President of Accreditation Services, says Legend Technical Services has been a customer of A2LA for ten years now. “As the only hemp testing laboratory recognized by the Minnesota Department of Agriculture, we are proud they have chosen to expand their A2LA accreditation to include hemp testing,” says McInturff. “We are also very proud to add yet another state to the ever-growing list of states that are relying upon A2LA as their accreditation body.”
According to a press release, Stillwater is also the first in the state to go through a dual assessment, a new program put in place Fall of 2018. Both ISO/IEC 17025 accreditation and Americans for Safe Access (ASA) Patient Focused Certification were obtained by the lab. Stillwater achieved the recently updated ISO 17025:2017 accreditation.
“Stillwater Labs is honored to achieve ISO/IEC 17025:2017 accreditation” says Dr. Ron Brost, laboratory director Stillwater. “Quality methods are the cornerstone of our operations, and accreditation through the A2LA has been a valuable developmental process. We used the opportunity to refine, clarify, and tune our systems in order to bring world-class analytics to our clients in Montana. We look forward to continuing to drive advanced technologies coupled with excellent customer service through ISO/IEC 17025 best practices.”
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.
AOAC INTERNATIONAL is an independent, third party, not-for-profit association and voluntary consensus standards developing organization. Founded in 1884, AOAC INTERNATIONAL was originally coined the Association of Official Agricultural Chemists. Later on, they changed their name to the Association of Official Analytical Chemists. Now that their members include microbiologists, food scientists as well as chemists, the organization officially changed its name to just AOAC INTERNATIONAL.
Much of AOAC’s work surrounds promoting food safety, food security and public health. Their work generally encompasses setting scientific standards for testing methodology, evaluating and adopting test methods and evaluating laboratory proficiency of test methods. The organization provides a forum for scientists to develop microbiological and chemical standards.
In December of 2018, they appointed Dr. Palmer Orlandi as deputy executive director and chief science officer. Dr. Orlandi has an extensive background at the U.S. Food and Drug Administration (FDA), serving the regulatory agency for more than 20 years. Most recently, he was the CSO and research director in the Office of Food and Veterinary Medicine at the FDA. He earned the rank of Rear Admiral and Assistant Surgeon General in 2017.
Where It All Began With Cannabis
As recently as three years ago, AOAC began getting involved in the cannabis laboratory testing community, with a working group dedicated to developing standard method performance requirements for AOAC Official MethodsSM for cannabis testing. We sat down with Dr. Palmer Orlandi and a number of AOAC’s leaders to get an update on their progress working with cannabis testing as well as food security and food fraud.
According to Scott Coates, senior director of the AOAC Research Institute, they were approached three years ago to set up a working group for cannabis testing. “We created standards that we call the standard method performance requirements (SMPR®), which are detailed descriptions of what analytical methods should be able to do,” says Coates. “Using SMPRs, we issued a series of calls for methods and looked for methods that meet our standards. So far, we’ve completed four SMPRs- cannabinoids in plant material, cannabinoids in plant extracts, cannabinoids in chocolate (edibles), and one for pesticides in cannabis plant material.” AOAC doesn’t develop methods themselves, but they perform a comprehensive review of the methods and if they deem them acceptable, then the methods can be adopted and published in the AOAC compendium of methods, the Official Methods of Analysis of AOAC INTERNATIONAL.
Deborah McKenzie, senior director of Standards and Official MethodsSM at AOAC, says the initial working group set the stage for really sinking their teeth into cannabis testing. “It started with methods for testing cannabinoids in plant dried material and plant extract,” says McKenzie. “That’s where our previous work has started to mold into the current effort we are launching.” McKenzie says they are looking forward to getting more involved with methods regarding chemical contaminants in cannabis, cannabinoids in various foods and consumables, as well as microbial organisms in cannabis. “We are pretty focused on testing labs having reliable and validated analytical solutions as our broad goal right now.”
Moving Forward, Expanding Their Programs
Coates says the work they’ve done over the past few years was more of a singular project, developed strictly for creating standards and to review methods. Now they are currently developing their Cannabis Analytical Science Program (CASP), which is expected to be an ongoing program. “We are looking to fully support the cannabis analytical community as best we can, which will potentially include working on reference materials, proficiency testing, education, training and ISO 17025 accreditation, all particularly as it applies to lab testing in the cannabis industry,” says Coates. “So, this CASP work is a much bigger and broader effort to cover more and to provide more support for labs doing the analysis of cannabis and its constituents, as well as hemp.”
According to Dr. Orlandi, they want this program to have a broad reach in the cannabis testing community. “As Scott pointed out, it’s not just strictly developing standards and methods,” says Dr. Orlandi. “It is going to be as all-encompassing as possible and will lead to training programs, a proficiency testing program and other areas.” Arlene Fox, senior director of AOAC’s Laboratory Proficiency Testing Program, says they are actively engaging in proficiency testing. “We are in the process of evaluating what is out there, what is possible and what’s needed as far as expanding proficiency testing for cannabis labs,” says Fox.
Regulatory Challenges & Obstacles
The obvious roadblock to much of AOAC’s work is that cannabis is still considered a controlled substance. “That creates some challenges for the work that we do in certain areas,” says Dr. Orlandi. “That is why this isn’t just a one-year project. We will work with these challenges and our stakeholders to address them.” AOAC had to put some limits on participation- for example, they had to decide that they cannot look for contributions or collaborations with producers and distributors, so long as cannabis is still a Schedule I controlled substance in the US.
Muddying the waters even further, the recent signing of the Farm Bill puts a clear distinction between most types of cannabis and industrial hemp. David Schmidt, executive director of AOAC realizes they need to be realistic with their stakeholders and in the eye of federal law.
While scientifically speaking, it’s pretty much the same plant just with slightly different chemical constituents, AOAC INTERNATIONAL has to draw a line in the sand somewhere. “As Palmer suggests, because of the Farm Bill being implemented and hemp being defined now as a legal substance from a controlled substance standpoint, industrial hemp has been given this exclusion,” says Schmidt. “So, we are trying to be realistic now, working with our stakeholders that work with hemp, trying to understand the reality of the federal law. We want to make clear that we can meet stakeholder needs and we want to distinguish hemp from cannabis to remain confident in the legality of it.” Schmidt says this is one of a number of topics they plan on addressing in detail at their upcoming 9thannual 2019 Midyear Meeting, held March 11-14 in Gaithersburg, Maryland.
Uniformity in Methodology: The Future of Cannabis Testing
Dr. Orlandi says his experience at the FDA has prepared him well for the work being done at AOAC. “The role that I served at the FDA prior to joining my colleagues here at AOAC was very similar: And that is to bring together stakeholders to accomplish or to solve a common problem.” Some of their stakeholders in the CASP program include BC Testing, Inc., the Association of Food and Drug Officials (AFDO), Bia Diagnostics, Bio-Rad, Industrial Laboratories, Materia Medica Labs, PerkinElmer, R-Biopharm AG, Supra R & D, TEQ Analytical Laboratories, Titan Analytical and Trilogy Analytical, among others.
“The underlying reason behind this effort is to create some level of harmonization for standards and methods,” says Dr. Orlandi. “They can be used in the near future to stay ahead of the curve for when regulatory agencies become involved. The idea is that these standards for analytical methods will already be established and as uniform as possible.”
When comparing cannabis to other industries in the US, Scott Coates mentions that most standards are signed off by the federal government. “When we started looking at pesticides in cannabis, it became really clear that we have a number of states doing things differently with different limits of quantification,” says Coates. “Each state, generally speaking, is setting their own standards. As Palmer was saying, one thing we are trying to do with this CASP program eventually will be to have some harmonization, instead of 30 different states having 30 different standards and methods.” So, on a much broader level, their goal for the CASP program is to develop a common set of standard methods, including hemp testing and even the Canadian market. “Hopefully this will be an international collaboration for standards for the methodology,” says Coates. They want to create a common set of standards, setting limits of quantification that will be accepted internationally, that will be accurate and repeatable and for the entire cannabis industry, not just state by state.
Food Authenticity & Fraud
One of the other activities that AOAC just launched recently is the food authenticity and fraud program. As the name implies, the goal is to start developing standards and methods and materials to look at economically adulterated foods, says Dr. Orlandi. That includes non-targeted analyses looking at matrices of food products that may be adulterated with an unknown target, as well as targeted analytes, identifying common adulterants in a variety of food products. “One example in the food industry is fraudulent olive oil,” says Dr. Orlandi. “Honey is another commodity that has experienced adulteration.” He says that in most cases these are economically motivated instances of fraud.
By Ravi Kanipayor, Christian Bax, Dr. George Anastasopoulos No Comments
As state cannabis regulatory frameworks across the country continue to evolve, accreditation is becoming increasingly important. Because it provides consistent, turnkey standards and third-party verification, accreditation is quickly emerging as an important tool for regulators. For cannabis testing laboratories, this trend has been especially pronounced with the increasing number of states that require accreditation to ISO/IEC 17025.
As of 2017 there were nearly 68,000 laboratories accredited to ISO/IEC 17025, making it the single most important benchmark for testing laboratories around the world. ISO/IEC 17025:2005 specifies the general requirements for the competence to carry out tests including sampling. It covers testing performed using standard methods, non-standard methods and laboratory-developed methods. It is applicable to all organizations performing tests including cannabis labs. The standard is applicable to all labs regardless of the number of personnel or the extent of the scope of testing activities. Developed to promote confidence in the operation of laboratories, the standard is now being used as a key prerequisite to operate as a cannabis lab in many states.
There are currently 26 states in the United States (also Canada) that require medical or adult-use cannabis to be tested as of February 2019. Of those states, 18 require cannabis testing laboratories to be accredited – with the vast majority requiring ISO/IEC 17025 accreditation. States that require testing laboratories to attain ISO/IEC 17025 accreditation represent some of the largest and most sophisticated cannabis regulatory structures in the country, including California, Colorado, Maryland, Massachusetts, Michigan, Nevada and Ohio. As a consequence, many cannabis testing laboratories are taking note of recent changes to ISO/IEC 17025 standards.
ISO/IEC 17025 was first issued in 1999 by the International Organization for Standardization. The standard was updated in 2005, and again in 2017. The most recent update keeps many of the legacy standards from 2005, but adds several components – specifically requirements for impartiality, risk assessment and assessing measurement uncertainty. The remainder of this article takes a deeper dive into these three areas of ISO/IEC 17025, and what that means for cannabis testing laboratories.Objectivity is the absence or resolution of conflicts of interest to prevent adverse influence on laboratory activities.
ISO/IEC 17025:2005 touched on an impartiality requirement, but only briefly. The previous standard required laboratories that belonged to organizations performing activities other than testing and/or calibration to identify potential conflicts of interest for personnel involved with testing or calibration. It further required that laboratories had policies and procedures to avoid impartiality, though that requirement was quite vague.
ISO/IEC17025:2017 emphasizes the importance of impartiality and establishes strict requirements. Under the new standard, labs are responsible for conducting laboratory activities impartially and must structure and manage all laboratory activities to prevent commercial, financial or other operational pressures from undermining impartiality. The definitions section of the standard defines impartiality as the “presence of objectivity.” Objectivity is the absence or resolution of conflicts of interest to prevent adverse influence on laboratory activities. For further elaboration, the standard provides similar terms that also convey the meaning of impartiality: lack of prejudice, neutrality, balance, fairness, open-mindedness, even-handedness, detachment, freedom from conflicts of interest and freedom from bias.
To comply with the new standard, all personnel that could influence laboratory activities must act impartially. ISO/IEC 17025:2017 also requires that laboratory management demonstrate a commitment to impartiality. However, the standard is silent on how labs must demonstrate such commitment. As a starting point, some cannabis laboratories have incorporated statements emphasizing impartiality into their employee handbooks and requiring management and employee training on identifying and avoiding conflicts of interest.
Both the 2005 and 2017 versions contain management system requirements. A major update to this is the requirement in ISO/IEC 17025:2017 that laboratory management systems incorporate actions to address risks and opportunities. The new risk-based thinking in the 2017 version reduces prescriptive requirements and incorporates performance-based requirements.
Under ISO/IEC 17025:2017, laboratories must consider risks and opportunities associated with conducting laboratory activities. This analysis includes measures that ensure that:
The lab’s management system is successful;
The lab has policies to increase opportunities to achieve its goals and purpose;
The lab has taken steps to prevent or reduce undesired consequences and potential failures; and
The lab is achieving overall improvement.
Labs must be able to demonstrate how they prevent or mitigate any risks to impartiality that they identify.To comply with ISO/IEC 17025:2017, labs must plan and implement actions to address identified risks and opportunities into management systems. They must also measure the effectiveness of such actions. Importantly, the standard requires that the extent of risk assessments must be proportional to the impact a given risk may have on the validity of the laboratory’s test results.
ISO/IEC 17025:2017 does not require that labs document a formal risk management process, though labs have discretion to develop more extensive methods and processes if desired. To meet the requirements of the standard, actions to address risks can include sharing the risk, retaining the risk by informed decision, eliminating the risk source, pinpointing and avoiding threats, taking risks in order to pursue an opportunity, and changing the likelihood or consequence of the risk.
ISO/IEC 17025:2017 references “risks” generally throughout most of the standard. However, it specifically addresses risks to a laboratory’s impartiality in section 4.1. Note, the new standard requires that labs must not only conduct activities impartially, but also actively identify risks to their impartiality. This requirement is on-going, not annually or bi-annually. Risks to impartiality include risks arising from laboratory activities, from laboratory relationships, or from relationships of laboratory personnel. Relationships based on ownership, governance, shared resources, contracts, finances, marketing, management, personnel and payment of a sales commission or other inducements to perform under pressure can threaten a laboratory’s impartiality. Labs must be able to demonstrate how they prevent or mitigate any risks to impartiality that they identify.
Assessing Measurement Uncertainty With Decision Rules
ISO/IEC 17025:2005 required (only where necessary and relevant) test result reports to include a statement of compliance/non-compliance with specifications and to identify which clauses of the specification were met or not met. Such statements were required to take into account measurement uncertainty and if measurement results and uncertainties were omitted from the statement, the lab was required to record and maintain the results for future reference.
ISO/IEC 17025:2017 requires similar statements of conformity with an added “decision rule” element. When statements of conformity to a specification or standard are provided, labs must record the decision rule it uses and consider the level of risk the decision rule will have on recording false positive or negative test results. Like the 2005 version, labs must include statements of conformity in test result reports (only if necessary and relevant- see 18.104.22.168 (b)). Now, test result reports on statements of conformity must include the decision rule that was employed.
Because many states require ISO/IEC 17025 accreditation for licensing, cannabis testing labs across the country would be well advised to closely monitor the implications of changes in ISO/IEC 17025:2017 related to impartiality, risk assessment and measurement uncertainty. If you run a cannabis testing lab, the best way to ensure compliance is education, and the best place to learn more about the new requirements is from a globally recognized accreditation body, especially if it is a signatory to the International Laboratory Accreditation Cooperation (ILAC) for testing laboratories, calibration laboratories and inspection agencies.
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