Dana Ciccone, chief executive officer of Steep Hill Hawaii, has been a patient advocate and leader in cannabis education in Hawaii, as well as a member of the Hawaii Medical Marijuana Dispensary Task Force, an organization formed by the University of Hawaii College of Social Sciences Public Policy Center to develop regulations for the state. “We are proud not only to be the first cannabis lab to be licensed in the State of Hawaii, but also now the first lab to achieve ISO certification as well,” says Ciccone. “Industry businesses, medical professionals, state regulators, and patients can be confident that our lab and its testing standards will operate to the highest international standards.”
According to the press release, the laboratory will offer services for testing cannabinoid profiles (potency), terpenes, pesticides, heavy metals, biological screening, and residual solvents, testing for 17 Cannabinoids and 43 terpenes. The release states they are locally owned and operated, providing testing services for not just industry businesses, but in-state card-holding patients as well.
“This is a turning point for the industry – we have moved very quickly to raise the industry standards in Hawaii to internationally recognized certification,” says Ciccone. “I am very proud our scientific team for the professionalism and hard work they put in to achieve this certification.”
Earlier this week, SC Labs issued a press release announcing they achieved ISO/IEC 17025:2005 accreditation for the cannabinoids panel at their Santa Cruz location.
“We are thrilled to announce our ISO accreditation as this is one of our most important achievements over the past seven years of serving the cannabis industry and demonstrates our commitment to serving our clients with integrity,” says Jeff Gray, co-founder and chief executive officer of SC Labs. ISO 17025 accreditation represents an international standard for a laboratory’s technical competence in producing accurate test results.
“Being accredited to this International Standard demonstrates our robust quality system, technical competence, the calibration and suitability of our instrumentation and our ability to produce precise and accurate test data,” says Gray. “For clients, it enhances their confidence in our services and their choice in a business partner, provides them with additional legal defensibility in complying with upcoming regulations, and enhances the integrity of their products based on SC Labs results.”
SC Labs is currently expanding in California, growing their Southern California and Santa Cruz locations, and adding field offices throughout the state, according to the press release.
This complimentary, 1-hour webinar will delve into the details of laboratories, analytics and all things cannabis laboratory accreditation.
Juniper Labs is a fully accredited cannabis laboratory in Bend, Oregon, whose business model is to perform all cannabis testing in-house and control analytical quality to maximize profitability. Learn how they successfully navigated the certification process through expertise management, capital expenditures, designing a detailed plan for success and achieved accreditation under Oregon’s ORELAP requirements. PerkinElmer reviews some of the instruments, processes and procedures used to support accreditation in the cannabis lab testing market. In addition, explore the variety of cannabis products, legality in the US, taxonomy and much more.
This live webinar is divided into three sections and will conclude with a “Question and Answer” session that will help attendees better understand what lab managers face when going through the accreditation process.
Emerald Scientific’s Inter-Laboratory Comparison and Proficiency Test (ILC/PT) was recently approved in Washington as an official cannabis lab PT program, according to a press release. The Emerald Test program measures the accuracy of individual labs as well as comparing their results to other labs for indicators of variability and performance improvement.
Washington requires certified cannabis labs to participate in proficiency testing and Emerald Scientific’s tests is the only approved program in 4 out of 5 of the categories: potency, pesticide, heavy metals and residual solvent analysis. The most recent round of The Emerald Test showed broad improvements in many of the testing categories.
Perry Johnson, a third-party lab accreditation service for ISO/IEC 17025 also decided that The Emerald Test “meets the audit criteria for the proficiency test participation requirement for the accreditation,’ according to the press release. The proficiency test is a key component of quality assurance, which is a major requirement for labs seeking ISO 17025 accreditation. “The Emerald Scientific PT ensures that the cannabis testing labs are performing their function to the best of their ability,” says Reggie Gaudino Ph.D., vice president of Science, Genetics and Intellectual Property at Steep Hill Labs. “Any lab that isn’t participating and exceeding the minimal passing requirements should be viewed as suspect. It’s that important.”
According to the press release, Emerald Scientific’s spring 2017 program has expanded from 5 to 6 tests. The residual solvents and pesticide analysis portions offer more comprehensive testing that previously. “The other tests include 2 microbial panels and a Potency Test, which measures 5 cannabinoids including THC, THCA, CBD, CBDA, and CBN,” says the press release. “New this spring is the Heavy Metals Test, which is offered in 2 parts, one solution for cannabis heavy metals and the other in a hemp matrix.”
A certified reference material (CRM) is generally recognized as providing the highest level of traceability and accuracy to a measurement. A CRM designed specifically for cannabis testing and tailored to state-specific testing regulations could help laboratories better ensure the safety of their products.
The fact that a certificate accompanies a reference material does not qualify it as a CRM. The reference material must be produced in accordance with ISO Guide 34 specifications by an accredited manufacturer. Adam Ross, key account manager and organic specialist at LGC Standards, says accreditation is a big part of bringing legitimacy to cannabis testing. “For a laboratory to receive an ISO 17025 accreditation, they must purchase their RMs from an ISO 17025 manufacturer. The best option is to purchase an ISO Guide 34 manufactured CRM,” says Ross. “It is particularly important for testing requirements, such as potency, pesticides, etc., where quantitation is expected, to use properly certified quantitative reference materials.” LGC Standards, a 175-year-old company, is one of those manufacturers that invested the time and money to achieve ISO Guide 34 accreditation and offers a spectrum of CRMs for cannabis testing.
The major advantage to using a proper CRM is an increased level of credibility. Auditors recognize the value of using a CRM which can add to the integrity of the results produced. The regular use of certified reference standards along with proper training, methodology and instrumentation, will facilitate a result that has the least amount of uncertainty and is more defendable. “The regular use of certified reference standards will help ensure products that go to market are safe to consume,” says Ross.
With regard to potency analyses, Ross has some key insights to help a laboratory better utilize CRMs. “My advice? Don’t mix the cannabinoids; labs analyzing by GC/FID have discovered that some of the cannabinoids will co-elute. Also, they have a short shelf life when mixed together,” says Ross. “Cannabinoid analysts should use GC/MS or LC/MS for their analysis or analyze the cannabinoids individually,” says Ross.
So what happens if a cannabis lab uses non-certified reference materials? Labs might save money in the short term. CRMs are slightly more expensive than a non-certified reference material, but will increase the defensibility of a lab’s data. Using a reference material created in-house or from a non-accredited vendor can lead to less-than-accurate results. A non-certified reference material has a greater chance of being made incorrectly. The publication of incorrect data damages the credibility of the testing lab and could lead to legal action against the lab from damaged parties.
One of the major challenges for the cannabis testing industry is the variation in state-to-state regulations. Ross says that Oregon’s regulations are pretty comprehensive and that other states should look to the Oregon Environmental Laboratory Accreditation Program (ORELAP) for guidance. According to Ross, ORELAP would like to see higher quality standards with legitimate traceability. Utilizing CRMs the correct way will help laboratories achieve greater accuracy.
Here are some tips for using CRMs appropriately:
Always bring your standards to room temperature before making a dilution.
Matrix matched calibration standards provide more accurate quantitation. Prepare standards in the solvent from extracted blank matrices.
Always bracket your analytical runs with continuing calibration verification standards. Proving that your instrument remained calibrated during the run gives your data more credibility.
Analytical chemists purchase CRMs for three primary uses in the testing lab:
To calibrate the instrument that will be used to perform the testing
To confirm the instruments continuing calibration throughout the analytical process
For analytical quality control or “spikes”
Typically, labs will spike known concentrations of the analytes of interest into a control sample and regular samples with the intent of testing analytical efficiency. Recoveries of analytes from the spiked control sample tell the chemist how well the analytical method is working. The spiked samples (matrix spikes) demonstrate to what extent the sample matrix (the consumable being tested) is influencing the results of the analytical procedure.
CRMs could be described as the nexus between cannabis testing results, the human element and the instrumentation used in an analysis. By using a cannabis-specific CRM, the cannabis testing community can demonstrate tangible improvements in accuracy and legitimacy.
The American Association for Laboratory Accreditation (A2LA) and Americans for Safe Access (ASA) announced yesterday a collaboration to develop a cannabis-specific laboratory accreditation program based upon the requirements of ISO/IEC 17025 and ASA’ s Patient Focused Certification (PFC) Program. Accreditation under this program will offer the highest level of recognition and provide the most value to the laboratory and users of the products tested, according to a press release published yesterday. ASA is the largest medical cannabis patient advocacy group in the United States. “A2LA is pleased to partner with ASA to offer a cannabis testing laboratory accreditation program to ISO/IEC 17025 as well as the additional laboratory requirements from ASA’s Patient Focused Certification Program,” says Roger Brauninger, biosafety program manager at A2LA.
The program affirms that cannabis laboratories are compliant with state and local regulations and ensures that they adhere to the same standards that are followed by laboratories used and inspected by the Environmental Protection Agency (EPA), the United States Department of Agriculture (USDA), and the U.S. Consumer Product Safety Commission (CPSC) among other regulatory bodies. The two non-profit organizations will offer their first joint training course at A2LA’s headquarters in Maryland from July 11th to the 15th. During this course, participants will receive training on PFC’s national standards for the cultivation, manufacture, dispensing, and testing of cannabis and cannabis products, combined with ISO/IEC 17025 training.
The guidelines for cannabis operations that serve as the basis for this accreditation program were issued by the American Herbal Products Association (AHPA) Cannabis Committee, an industry stakeholder panel, and have already been adopted by sixteen states. “We are very excited to see the PFC program join the ISO/IEC 17025 accreditation efforts to help fully establish a robust and reliable cannabis testing foundation,” says Jeffrey Raber, chief executive officer of The Werc Shop, a PFC-certified cannabis testing laboratory. “It is a great testament to ASA’s commitment to quality in their PFC program by partnering with a world-renowned accrediting body to set a new standard for cannabis testing labs.”
According to Kristin Nevedal, program director of PFC, this is an important first in the industry. “This new, comprehensive accreditation program affirms laboratory operations are meeting existing standards and best practices, adhering to the ISO/IEC 17025 criteria, and are compliant with state and local regulations,” says Nevedal. “This program is the first of its kind developed specifically for the cannabis industry, giving confidence to patients as well as regulators that their test results on these products are accurate and consistent.”
“The program will combine the expertise and resources of the country’s largest accreditation body with the scientific rigor and knowledge base of the nation’s largest medical cannabis advocacy group, benefitting the myriad of laboratories tasked with analyzing cannabis products,” says Nevedal. According to Brauninger, a cannabis-specific accreditation program is vital to the industry’s constantly shifting needs. “The ability to now offer a cannabis testing laboratory accreditation program that is tailored to address the unique concerns and issues of the industry will help to add the necessary confidence and trust in the reliability and safety of the cannabis products on the market,” says Brauninger. “Those laboratories that gain accreditation under this program will be demonstrating that they adhere to the most comprehensive and relevant set of criteria by their compliance to both the underlying framework of the internationally recognized ISO/IEC 17025:2005 quality management system standard and the specific guidelines issued by the AHPA Cannabis Committee.” This type of collaboration could represent a milestone in progress toward achieving a higher level of consumer safety in the cannabis industry.
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.
Living in a world of ever-increasing interdependence and an era of limited state government, financial and human resources, it is imperative that those charged with protecting the health and safety of patients and users of medical and recreational cannabis products leverage what private sector institutions and existing frameworks already offer in setting up quality standards for laboratory testing operations. That this moment arrives now – at a point where state governments are being tasked with undertaking the most significant change in the regulation of this substance whilst the federal government appears unwilling to play a substantial role – makes this partnership both inevitable and absolutely necessary.
Accreditation is an internationally accepted conformity assessment tool for ensuring laboratory competence and confidence in the accuracy and reliability test data. The accreditation infrastructure is well-established through accreditation bodies (ABs) and the Mutual Recognition Arrangement (MRA) of the International Laboratory Accreditation Cooperation (ILAC), supported by regional cooperative arrangements, including those of the Asia Pacific Laboratory Accreditation Cooperation (APLAC) and the Inter-American Accreditation Cooperation (IAAC). ILAC functions as a forum for harmonization of laboratory accreditation procedures and policies, thus reducing technical barriers to trade and promoting laboratory accreditation as a mechanism for establishing confidence in testing facilities. ILAC MRA signatory ABs are recognized, through a rigorous peer evaluation process, as competent to accredit testing organizations. All signatory ABs must meet the requirements of ISO/IEC 17011 and use ISO/IEC 17025 as the basis for accreditation of laboratories. In turn, under the ILAC MRA and the regional co-operations, competent laboratories are recognized globally, thus facilitating acceptance of the test results that accompany goods across international borders.
In other areas, such as the food supply and energy, both state and federal government have been an active participant in accreditation activities. According to The Administrative Conference of the United States in its Agency Use of Third-Party Programs to Assess Regulatory Compliance*, “…agencies in diverse areas of regulation have developed third-party programs to assess whether regulated entities are in compliance with regulatory standards and other requirements. Through these programs, third parties are charged with assessing the safety of imported food… Third parties also ensure that products labeled as organic and energy-efficient meet applicable federal standards. In these regulatory third-party programs, regulated entities generally contract with third parties to carry out product testing and other regulatory compliance assessment activities in the place of regulatory agencies. Regulatory agencies take on new roles in coordinating and overseeing these third-party actors.” While this reference largely deals with areas outside of cannabis regulation, it remains useful and relevant because of the manner in which cannabis products are used.
Traditionally, ABs have worked with regulators to establish specific technical requirements to supplement the ISO/IEC 17025 accreditation framework. In this partnership, the AB is responsible for executing the assessment and accreditation process but the regulator retains responsibility for the ultimate decisions on the acceptance of that organization’s accreditation. In the example of our food supply and its various sources, governmental recognition of accreditation bodies operating in accordance with international standards is much more practical than government agencies themselves accrediting the individual testing organizations or ABs. Thus the public/private partnership paradigm: To assess regulatory compliance a Regulatory Agency approves ABs that accredit organizations that assess whether Regulated Entities or Regulated Products are in conformity with a Regulatory Standard.*
In this example, all of the organizations are treated equally by the regulatory agency since they use the same recognition criteria for ABs and the same accreditation requirements in the assessment of conformity assessment bodies. This approach would also provide consistency at a point in time where many states are grappling with trying to find the best quality standard to use and which, to date, has resulted in many different standards being chosen or considered for implementation. This is especially true when one looks at the requirements put into place by the “early adopter” states. However, in those states that have entered this area more recently, it seems clear that the consensus is use of ISO/IEC 17025 as the most appropriate quality management standard for testing laboratories.
There are many factors to consider when selecting a third party analytical laboratory:
Why are you testing?
Does a governing body require it?
Are you testing to meet compliance with industry trends?
Are you testing as supplemental protection to an in house laboratory operation?
Are your results being used to help you market your product?
Are the results being utilized for internal R&D?
What are you looking to get out of testing?
Perhaps it is a combination of all these things. Regardless, whomever you contract with for whatever reasons, it is important to understand what you are getting, know what you are entitled to, understand your results, and understand where you and your company remain vulnerable. You must also be prepared with a plan to handle adverse results. Testing at a third party analytical contract laboratory does not mean they assume all of your product’s or company’s liability, regardless of the lab’s reputation.
Ask your third party laboratory about any accreditations, certifications, and licenses that the lab should be accredited and/or certified for. Each state has different certifications and licensing requirements; make sure the entity you are using is licensed or certified for the services you need. Additionally, there is an accreditation called International Standards Organization (ISO) 17025 that is the pinnacle of third party laboratory accreditation. ISO 17025 is a set of protocols that your third party lab should follow to do everything it can to ensure your data is accurate and produced with reliable standards, control samples, matrix control samples and proficiency tests to verify the accuracy of the lab’s employees and methods, among a number of other criteria included in the standard. A number of different entities offer accreditation to ISO 17025 but it is important that the the accrediting body is also accredited to their ISO standard. Simply buying ISO 17025 compliant materials or standards does not mean that the vendor service or product is accredited to ISO 17025. Cannabis laboratories are just starting to implement and build systems around ISO 17025 but it has been prevalent in the third party lab business in many industries for decades and should be applied to the cannabis industry.
Visit your lab and understand their background and experience. Start by requesting a tour of the laboratory you choose; you want to know how things look behind the scenes. Is the lab orderly and doing its best to protect sample integrity? There may be a lot of things going on in the laboratory and it may look chaotic but it should be relatively clean. This prevents contamination and sample mix-ups. Further your relationship with your laboratory by understanding the laboratory’s experience and getting to know your laboratory staff. Consider the lab staff as part of your extended team, they are there to help you and help bring your product to market. The more they understand your goals, the more they can help.
Understand your lab’s history and background: Have they worked with products and/or analytes similar to yours? Have they worked with your sample matrix or one similar to it before? Their prior knowledge and laboratory experience, as it relates to your product, will help provide accurate data and navigate complex matrices.
Most importantly, a laboratory should be willing to release the data packet that is used to generate test results to the client. Releasing this data does not divulge any proprietary information of the lab. It is the laboratory’s job to provide you with the data upon request. It is important to note, looking at your raw data is not the same as looking at the laboratory method, also known as a work instruction or operating procedure. The lab most likely won’t give you the method as those are typically trade secrets, but there is no reason not to share with you the chromatography that the HPLC, GC, GC/MS, or LC/MS generated. This will demonstrate the lab’s sound analytical data and increase your confidence in the analysis you are receiving. When you pay for the results, you are also paying for your data and if your laboratory is not releasing that information to you at your request, you should be skeptical. This data needs to be able to stand up to audits and legal action.
Finally, confidentiality: your data is your data. Yes, you may have to report results to a governing body, but your laboratory should not be sharing your name and your data with anyone but your authorized list of contacts without your permission. They should not even disclose that you are their client without your prior authorization. Confidentiality is not just applicable to a few key employees at the laboratory, it is pertinent to everyone from the sample pickup driver, if you have one, to the chemists and upper level management.
Understanding your contract laboratory’s certifications, licenses, and accreditations, requesting and receiving raw data packages, and ensuring that you feel comfortable with the laboratory, its staff and their practices are key elements to ensuring a successful relationship with your laboratory.