AOAC International, an independent nonprofit standards development organization has announced the appointment of Dr. Katerina (Kate) Mastovska as their new deputy executive director and chief science officer.
Dr. Katerina Mastovska
Most recently, Dr. Mastovska served as chief science officer for the Eurofins US Food Division. She has been an active member of AOAC for almost twenty years, winning the Harvey W. Wiley Award in 2021, their highest scientific honor. “I’m delighted to join the AOAC staff and lead the team of dedicated scientists,” says Dr. Mastovska. “AOAC has a critical role in food safety, and I’m inspired to continue to be a part of this important work.”
AOAC International works actively in the cannabis industry through their Cannabis Analytical Science Program (CASP), a working group established in 2019 that is dedicated to developing standardized methods in cannabis testing. In the world of cannabis lab testing, AOAC International creates standards under the standard method performance requirements (SMPR®) moniker, which are detailed descriptions of what analytical methods should be able to do.
More recently, CASP launched their own proficiency testing program last year and launched their first round, shipping samples to labs across the country in the Fall.
When people have to make important decisions, we often consult a third party to increase our knowledge and confidence in a product. For instance, when choosing a car, an individual may weigh heavily on safety ratings and other awards from organizations such as Consumer Reports. These awards are often boasted and a heavy focus in car commercials because it tells the consumer that a third party has deemed their car valuable to own. For more than 100 years, the Association of Official Agricultural Chemists (AOAC® International) has operated in this exact manner, and has set the bar and guidelines for testing in the cannabis industry through its special program called the Cannabis Analytical Science Program, also known as CASP.
The CASP program is designed to develop standards and validation guidance to evaluate testing methods, as well as the methods’ ability to detect the target organism or compound on the cannabis matrix. With the addition of new states permitting the legal sale of both medical and adult use cannabis and no federal governing body overseeing testing regulations, the value of AOAC cannot be understated, as these guidelines allow cannabis testing laboratories to have their own third-party reference to look to when choosing a compliant testing method to implement in their laboratory.
AOAC was founded in 1884 by the US government as the standard setting body in the country and, in 1991, became an independent association known as AOAC International, with a goal of building a reputation as an international, consensus-based standard-setting body and a conformity assessment organization in analytical sciences. As an independent third-party resource, AOAC has the Performance Tested Methods’ (PTM) and Official Methods of AnalysisSM (OMA) programs for certification of analytical testing methods in both biology and chemistry.
If analytical methods, including proprietary test kits, are deemed acceptable, AOAC provides approved certification, their seal of approval that the method works as designed. Though multiple factors are considered to determine if AOAC approval is given; accuracy and precision of the method are among the most important. For example, when validating a cannabis method for microbiology, AOAC will contract an independent testing facility to conduct a series of tests with known spiked samples to measure the recovery limit of the target microorganism. This allows the organization to determine if the method is sensitive enough to be named an AOAC-approved method through either the PTM or OMA conformity programs. Another way of ensuring the validity of results is by conducting an inclusivity and exclusivity study on a method. In this type of experiment, target organisms are tested while also spiking with non-target organisms to see if there will be a high rate of false positives.
In cannabis, discussions have grown surrounding testing of four strains of Aspergillus, which are A. terreus, A. flavus, A. fumigatus and A. niger. By spiking cannabis with one of the four Aspergillus strains and on a separate sample with a non-target Aspergillus strain such as A. clavatus, it ensures that only the target strains are being recognized and recorded on the method being tested.
This methodology limits the likelihood of unconfirmed positives occurring, ensuring the validity of the results. Of course, when a method is undergoing an actual AOAC evaluation for approval, the testing requirements for both the sensitivity and inclusivity/exclusivity experiments are much more thorough than the explanation above.
Regardless of which AOAC-approved method you select, you can feel confident that most of the “heavy-lifting” is done and that the method is accurate and precise enough to implement in a cannabis testing facility. In turn, the cannabis testing laboratory then only needs to complete their own internal method verification to ensure the method works with their processes, people, environment and product, but on a much smaller scale and aligns with state regulations.
On a consumer safety level, AOAC-approved methods are designed to keep cannabis consumers safe. Whether they are an adult using cannabis or medicinal cannabis patient, the product that is being sold should be held to the highest safety standards. By having a laboratory that is utilizing an independently approved AOAC method, an additional layer of confidence is achieved that the product being consumed is safe. This ultimately limits the number of costly recalls from dispensaries and minimizes risk to consumers. At the end of the day, cannabis testing laboratories want to keep the public safe and it is our job to do so. This means implementing these independently approved methods from agencies such as AOAC at various touch points in the seed to sale cycle to ensure the data is validated and reliable.
Overall, just as it is equally important to get a non-biased and reputable third-party approach to your automobile search, a scientist that is responsible for choosing methods in their cannabis compliance laboratory should also consider these third-party approvals. As a scientist, the goal every day is to report accurate data to help the client and the consumer equally. The cannabis compliance laboratories are the last line of defense in preventing harmful or contaminated products from getting into the marketplace and any extra assurance we have with our testing methodology is always encouraged. Ultimately, AOAC’s work is important and their standard of quality and safety is a must-have in the cannabis laboratory.
In a press release published this week, AOAC International announced it has partnered with Signature Science, LLC as the test material provider for the new AOAC Cannabis/Hemp Proficiency Testing program. What makes this proficiency testing (PT) program so unique is that AOAC will be the only PT provider to offer actual cannabis flower as the matrix.
This month, the pilot round with twenty cannabis testing labs begins with hemp-only samples being shipped in early May. The first live round of the PT program is scheduled for November of this year and will offer participating labs the choice of cannabis flower samples or hemp samples.
The program will include one sample for cannabinoid and terpene profiles, moisture and heavy metals, as well as a second sample for pesticide residue testing. According to the press release, mycotoxins will be added to the mix soon.
The new PT program was developed by stakeholders involved with the AOAC Cannabis Analytical Science Program (CASP), including state regulatory labs, industry labs, state and federal agencies and accreditation bodies. Shane Flynn, senior director of AOAC’s PT program, says the program is a result of scientists coming to them with concerns about testing in the cannabis space. “AOAC has a long history of bringing scientists together to address emerging topics, so when stakeholders came to AOAC with their concerns and need for quality proficiency testing in the cannabis industry, AOAC acted,” says Flynn. “Stakeholders noted the analytical differences in testing cannabis versus hemp and had specific concerns around it and asked for a program that would provide actual cannabis samples in addition to hemp. This is truly a program that was created by the stakeholders, for the stakeholders.”
AOAC says they plan on introducing microbiology to the PT program, with microbial contamination tests in both cannabis and hemp samples. They are also considering adding additional matrices, like chocolate and gummies.
Signature Science is an ISO 17043 accredited proficiency test provider that also has a DEA-licensed controlled substances lab, making them an ideal candidate to partner with AOAC for the PT Program. They entered into a 3-year MoU with AOAC for the program. Their team developed and validated methods used to create the samples for the PT program at their DEA-licensed lab in Austin, Texas.
In a press release sent out this month, bioMérieux announced they have received the very first approvals in cannabis and hemp for AOAC Research Institute Performance Testing Methods (PTM). AOAC approved method validation for the detection of Salmonella and STEC (Shiga toxin-producing E. coli) in cannabis flower utilizing bioMérieux GENE- UP® SLM2 (PTM 121802) and EHEC (PTM 121806) assays.
According to the press release, these validations are the first of their kind in the cannabis and hemp industries. The AOAC-validated testing methods are approved for 1-gram and 10-gram samples.
Dr. Stan Bailey, senior director of scientific affairs at bioMérieux, says these approvals demonstrate the company’s commitment to innovative and validated science in the cannabis and hemp industries. “We are especially proud that the GENE-UP SLM2 and EHEC are the first two AOAC approvals in the United States for cannabis and hemp,” says Dr. Bailey. “This is increasingly important with now over half the population of the US living in states that have approved cannabis for recreational use and most states approving cannabis for medical use.”
The AOAC PTM designations are recognized by the US Department of Agriculture, the Food and Drug Administration, and global regulatory agencies. The validation guidance builds on AOAC’s Cannabis Analytical Science Program (CASP).
bioMérieux is a French in vitro diagnostics company that serves the global testing market. They provide diagnostic solutions such as systems, reagents, software and services.
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.
Dr. Palmer Orlandi is the new Deputy Executive Director and Chief Science Officer at AOAC.
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 Methods at AOAC
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.
Arlene Fox, senior director of AOAC’s Laboratory Proficiency Testing Program
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.
David Schmidt, executive director of AOAC
“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.
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