Earlier this month, Colorado cannabis producer Herbal Wellness LLC recalled dozens of batches of cannabis due to positive yeast and mold tests. The Colorado Department of Public Health and Environment (CDPHE) issued a health and safety advisory following the news of microbial contamination.
The Colorado Department of Revenue then identified batches of both medical and recreational cannabis produced by Herbal Wellness that were not even tested for microbial contaminants, which is a requirement for licensed producers in the state. Just a few days later, the Denver Department of Public Health & Environment (DDPHE) issued a bulletin announcing their plans to conduct random tests at dozens of dispensaries.
“In the coming weeks, the Denver Department of Public Health & Environment (DDPHE) will be conducting an assessment in approximately 25 retail marijuana stores to evaluate contaminants in products on store shelves,” reads the bulletin. “DDPHE has worked with epidemiological partners at Denver Public Heath to create the assessment methodology. Participating stores will be randomly identified for inclusion in the assessment.”
“Current METRC inventory lists for each store will be used to randomly identify samples of flower, trim/shake, and pre-rolls. Each sample will be tested for pesticides and total yeast and mold by a state- and ISO-certified marijuana testing facility. Results of their respective testing will be shared with each facility and will also be shared broadly within a write-up of results.”
Today in the states where medical and recreational cannabis is legal, cannabis products purchased from licensed facilities are required to have undergone testing by accredited labs. The compliance testing verifies advertised potency levels and checks for microbial contamination, herbicides, pesticides, fungicides and the presence of mold and mildew, among other potential contaminants.
Until recently, little attention has been given to disposable gloves and their possible involvement in the contamination of the products they handle. What factors should you consider when purchasing gloves?
Disposable Gloves Facts
Disposable gloves, like cannabis products, are not made of equal quality. There are several different types of disposable gloves on the market, and huge variations in glove quality and chemical compositions exist between and within each glove type.
Recent scientific studies have revealed how gloves produced in factories with poor manufacturing standards and raw material ingredients can contaminate the products they handle. High-level toxins in disposable gloves were found to affect lab results, toxins in gloves contaminated the food they touched, and pathogen contamination of unused disposable gloves has been proven. Should the cannabis industry take more interest in the disposable gloves they are using? With so much at stake if compliance test results are compromised, we think so!
Glove Procurement: Factors to Consider
What factors should you consider when purchasing gloves?
Industrial grade gloves- There is no such thing as an industrial grade glove certification, although it does give an incorrect impression that gloves are strong and resilient. Industrial grade means they have not been subjected to inspection nor have passed any specific testing requirements.
Food contact gloves are certified under FDA Title 21 CFR Part 177, which states the components of the glove comply with the FDA regulations and the gloves consist of “substances generally recognized as safe for use in food or food packaging.” Few controls exist for glove manufacturing relating to the reliability of raw materials and manufacturing processes, and costs can be reduced with the use of cheap, toxic materials.
Medical grade gloves have to pass a series of technical tests in order to meet the safety requirements specified by the FDA. Gloves are tested for puncture and abrasion resistance, must meet tension and elongation tests and are also tested for chemical substance resistance. Manufacturers of these gloves must receive 510k certification. As this study shows, even medical gloves can contain high levels of toxic ingredients, affecting laboratory test results.
The Acceptable Quality Level (AQL) refers to a quality standard for measuring pinhole defects- the lower the AQL, the less defects the gloves have. There are no AQL requirements for food grade or industrial grade gloves, meaning there are no guidelines for the number of failures per box. Medical grade gloves must have an AQL of 2.5 or less, meaning 2.5 failed gloves per 100 gloves is an acceptable level.
For Californian cannabis companies, are your disposable gloves Prop. 65 compliant? Accelerator chemicals, such as 2-Mercaptobenzothiazole (MBT) found in some nitrile gloves, have recently been added to the Prop. 65 chemicals known to cause cancer.
How Gloves Can Contaminate Products
Physical, chemical and microbiological hazards have been identified in disposable glove supply chains. Gloves of any grade are not tested for cleanliness (microbial and bioburden levels), raw material toxicity and chemical composition, or pathogen contamination.
100% of glove factories supplying the United States are based in Southeast Asia. These factories are generally self-regulated, with FDA compliance required for a rough outline of the ingredients of the gloves rather than the final product. Few controls are required for glove manufacturing relating to the reliability of raw materials, manufacturing processes and factory compliance or conditions. A clear opportunity exists for accidental or intentional contamination within the glove-making process, especially to reduce costs.
In order to safeguard their customers from product contamination, a selection of tests and certifications, some of which are unique within the glove industry, are being implemented by glove supplier Eagle Protect. These tests make sure Eagle’s gloves coming into the United States are made in clean, well run factories, free of any type of contamination and are consistent in material makeup to original food safe specifications. This glove Fingerprint testing program, consists of a number of proprietary risk reduction steps and targeted third-party testing methods, includes gas chromatography combined with mass spectroscopy (GC/MS); surface free energy determination; in vitro cytotoxicity analysis; and microbial viability-linked metagenomic analysis.
With a great deal of faith placed on a glove supplier’s ability to deliver disposable gloves sight unseen, we believe these tests are essential to further reduce risks or pathogen contamination associated with them, keeping your cannabis products safe.
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.
In a few short weeks, the regulations in California’s cannabis market will expand to include more laboratory testing. The previous exemption for selling untested product will be eliminated come July 1st, meaning that every product on dispensary shelves will have to be tested for a number of contaminants.
According to William Waldrop, chief executive officer and co-founder of EVIO Labs, the state is currently finalizing a revision to the existing emergency rules, which is designed to target the potential supply bottleneck situation. “To help alleviate the bottleneck, the state is eliminating the field duplicate test on every batch of cannabis or cannabis products,” says Waldrop. “This will give the labs additional bandwidth to process more batches for testing.” So one test per batch is the rule now and batch sizes will remain the same. This, of course, is contingent on the state finalizing that revision to the emergency regulations.
In addition to that change, the state will expand the types of testing requirements come July 1st. New mandatory pesticide testing, expanded residual solvent testing and foreign materials testing are added in addition to the other tests already required.
With July 1st quickly approaching, many in California fear the rules could lead to a major market disruption, such as the previously mentioned bottleneck. Waldrop sees the elimination of duplicate testing as a preventative measure by the state. “It is a good move for the industry because it allows labs to test more batches, hopefully reducing the bottleneck come July,” says Waldrop. Still though, with only 26 licensed laboratories in the state as of March, testing facilities will have to meet higher demand, performing more tests and working with more clients.
EVIO Labs is preparing for this in a number of ways. They already have a lab in Berkeley and are working to expand their capacity for more analyses. In addition to their lab in Berkeley, the company is working to get three more locations operational as quickly as possible. “Right now, EVIO Labs is expanding through the identification of new market locations,” says Waldrop. “We have announced the acquisition of a facility in Humboldt and we are outfitting it for state-mandated testing. We have secured a location in LA, and licensing for LA just began as of June 1stso we are going through the local licensing process at this time. We are still moving through the licensing process for our facility in Costa Mesa as well.”
“In the meantime, we have expanded capacity of personnel in our Berkeley facility to support our client base until these other locations come online,” says Waldrop. “We are refining our business, bringing on additional equipment and more resources.” While the rules haven’t been implemented yet, Waldrop says he’s seen an uptick in business with licensed operators requesting more testing for the new July 1st standards.
While some might feel a bit panicky about how the new standards could disrupt the market, Waldrop says his clients are looking forward to it. “Our clients are very happy with the proposed new rules, because it reduces the cost of testing per batch, which will inherently reduce wholesale costs, making cannabis more affordable for patients and recreational users.”
As both recreational and medical cannabis legalization continues to progress across the country, each state is tasked with developing regulatory requirements to ensure that customers and patients receive clean cannabis for consumption. This requires cannabis to undergo laboratory testing that analyzes the presence of microbial impurities including yeast and mold.
Some states, such as Colorado, Nevada, Maine, Illinois and Massachusetts use total yeast and mold count testing (TYMC) and set a maximum yeast and mold count threshold that cultivators must fall below. Other states, such as California, require the detection of species-specific strains of Aspergillus mold (A. fumigatus, A. flavus, A. niger and A. terreus), which requires analyzing the DNA of a cannabis sample through polymerase chain reaction testing, also known as PCR.
Differences in state regulations can lead to different microbiological techniques implemented for testing.Before diving in further, it is important to understand the scientific approach. Laboratory testing requirements for cannabis can be separated into two categories: analytical chemistry methods and microbiological methods.
Analytical chemistry is the science of qualitatively and quantitatively determining the chemical components of a substance, and usually consists of some kind of separation followed by detection. Analytical methods are used to uncover the potency of cannabis, analyze the terpene profile and to detect the presence of pesticides, chemical residues, residuals solvents, heavy metals and mycotoxins. Analytical testing methods are performed first before proceeding to microbiological methods.
Microbiological methods dive deeper into cannabis at a cellular level to uncover microbial impurities such as yeast, mold and bacteria. The techniques utilized in microbiological methods are very different from traditional analytical chemistry methods in both the way they are performed and target of the analysis. Differences in state regulations can lead to different microbiological techniques implemented for testing. There are a variety of cell and molecular biology techniques that can be used for detecting microbial impurities, but most can be separated into two categories:
Methods to determine total microbial cell numbers, which typically utilizes cell culture, which involves growing cells in favorable conditions and plating, spreading the sample evenly in a container like a petri dish. The total yeast and mold count (TYMC) test follows this method.
Molecular methods intended to detect specific species of mold, such as harmful aspergillus mold strains, which typically involves testing for the presence of unique DNA sequences such as Polymerase Chain Reaction (PCR).
Among states that have legalized some form of cannabis use and put forth regulations, there appears to be a broad consensus that the laboratories should test for potency (cannabinoids concentration), pesticides (or chemical residues) and residual solvents at a minimum. On the other hand, microbial testing requirements, particularly for mold, appear to vary greatly from state to state. Oregon requires random testing for mold and mildew without any details on test type. In Colorado, Nevada, Maine, Illinois and Massachusetts, regulations explicitly state the use of TYMC for the detection of mold. In California, the recently released emergency regulations require testing for specific species of Aspergillus mold (A. fumigatus, A. flavus, A. niger and A. terreus), which are difficult to differentiate on a plate and would require a DNA-based approach. Since there are differences in costs associated and data produced by these methods, this issue will impact product costs for cultivators, which will affect cannabis prices for consumers.
EVIO Labs recently became the first cannabis laboratory in Florida to obtain ISO 17025 accreditation. Perry Johnson Laboratory Accreditation, Inc. (PJLA), an organization that provides third-party assessments to ISO/IEC 17025, accredited EVIO Labs. The assessment process that lead to ISO 17025 accreditation for EVIO Labs included a thorough review of their quality management system, their capability to perform potency and contaminant testing for cannabis products.
Tracy Szerszen, president and operations manager at PJLA, encourages this international standard for laboratories to provide confidence to end-users that the test results they receive are reliable. She says laboratories that achieve this accreditation are showing they have the proper tools, equipment and staff to provide accurate testing. “It is a very critical component of the industry, and becoming accredited provides the assurance that laboratories are performing to the highest standard,” says Szerszen. “EVIO Labs has taken the right step in their commitment towards meeting this standard and providing clean and safe cannabis for the patients of Florida.”
EVIO Labs provides cannabis testing for cannabinoid and terpene profiles, microbiological and pesticides contamination, residual solvent, heavy metals, mycotoxins, water activity and moisture content. Chris Martinez, co-founder and president of EVIO Labs Florida explains that the Florida Department of Health mandates that an independent third-party laboratory tests medical cannabis to ensure that these products are safe for human consumption. Martinez says their first priority is the safety of their patients, and ensuring that EVIO Labs provides clean and safe cannabis for Florida.
Martinez launched their laboratory with some help from Shimadzu last year. “Our Broward lab is powered by Shimadzu with over $1.2M in the latest testing equipment utilizing LCMS technology with the world’s fastest polarity switching time of 5 m/sec and scan speeds of 30,000 u/sec with UF Qarray sensitivity 90 times that of previously available technologies,” says Martinez. According to Martinez, their licensing agreement with EVIO Labs (OTC:SGBYD) marked a first for the publicly traded company with exclusivity in the Florida market. The agreement includes proprietary testing methodologies, operating procedures, training and support.
Every certificate of analysis is reviewed by a lab director with over 20 years of experience operating in FDA regulated labs. Martinez says that EVIO has some of the most advanced technology in the industry, which provides them the opportunity to quickly provide results, frequently as fast as a 24-hour period. Martinez and his team are currently building a 3,300 square-foot laboratory in Gainesville, which is expected to be running by March of this year.
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