Tag Archives: pesticides

June 5, 2019

Disposable Gloves: The Unregulated Cannabis Threat

By Lynda Ronaldson

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.

May 30, 2019

Arizona To Implement Mandatory Lab Testing

By Aaron G. Biros

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Good news came to patients using medical cannabis in Arizona earlier this week: Lawmakers in Arizona unanimously passed SB1494 through the state’s House and Senate, the bill requiring mandatory lab testing for medical cannabis products. Arizona Governor Doug Ducey is expected to sign the bill and has ten days to do so.

When Governor Ducey signs the bill into law it will mark the first time since the state legalized medical cannabis in 2011 that a measure to protect patient safety via lab testing will be implemented. According to the bill, beginning November 1, 2020, all cannabis products shall be tested prior to sales “to determine unsafe levels of microbial contamination, heavy metals, pesticides, herbicides, fungicides, growth regulators and residual solvents and confirm the potency of the marijuana to be dispensed,” (Page 6, Section 36-2803).

The bill requires dispensaries to provide test results to patients immediately upon request. Dispensaries need to display a sign notifying patients of their right to see “certified independent third-party laboratory test results for marijuana and marijuana products for medical use,” according to the text of the bill (Page 7, Section 36-2803.01).“There will have to be some serious planning, but other states have achieved this and we can too.”

Under the new bill, the Arizona Department of Health Services will adopt rules to certify and regulate labs, establishing requirements like health and safety protocols, mandatory quality assurance program and standards, chain of custody and sampling policies, adequate records, accreditation, proficiency testing, among other requirements (Page 6-7, Section 36-2803).

Ryan Treacy, co-founder of the Arizona Cannabis Laboratory Association (ACLA) and CEO/Founder of C4 Laboratories, says this is a major turning point for Arizona’s cannabis industry. “We have been devoid of regulations with regard to testing the entirety of the program since it was legalized; This will be a significant change,” says Treacy. “Now patients can make sure they are getting a safe and clean product and getting exactly what they paid for.”

For those in the know when it comes to cannabis testing in the United States, the new requirements will look very similar to other states with testing requirements. One particularly unique aspect of the new program, however, is the establishment of a “Medical Marijuana Testing Advisory Council,” made up of stakeholders representing different interests in Arizona’s cannabis industry. Members of the council will include representatives from dispensaries, labs, cultivators, concentrate producers, edibles producers, as well as registered patients, caregivers, a representative from the Arizona Department of Public Safety, a licensed health care provider and “any other members deemed necessary by the director,” reads the text of the bill (page 16, Section 36-2821).

Ryan Tracy, co-founder of the ACLA and founder/CEO at C4 Labs.

“Other states like California have complained about detection limits, while Arizona is taking a unique approach with an advisory council with stakeholders in the cannabis industry,” says Treacy. “So that when the Department of Health Services promulgates rules, they are taking into account the challenges in the cannabis industry specifically. We have a chance to do this right and avoid pitfalls we’ve seen in other states.”

One problem worth mentioning for Arizona’s cannabis industry: Dispensaries have not been required to test products for patients since medical cannabis was legalized back in 2011. That means many producers could be very used to operating procedures that don’t account for lab testing. With mandatory lab testing, some producers may be behind the curve when it comes to mitigating contamination.

According to Treacy, this could disrupt the supply chain a little bit. “When testing becomes mandatory in November 2020, dispensaries will need a full panel of tests performed on their samples,” says Treacy. “With the entire market now required to complete a full panel in depth analysis on each product, product testing will become a more time-consuming stop in the supply chain. So companies will need to work that into their plan to meet regulation requirements to prevent a bottleneck and maintain patients’ access to their cannabis medicine.”

Arizona has a chance to prevent that type of bottleneck seen in states that implemented testing requirements, like California for example. “When you have a habitual history of not testing products, it can be very hard to change, which adds to Arizona’s challenges,” says Treacy. “We need to make sure this does not affect access for patients and the ability of the industry to continue to flourish and grow.”

While Treacy thinks the transition will be difficult for some, it’s absolutely necessary for Arizona’s patients to access clean and safe medicine. “There will have to be some serious planning, but other states have achieved this and we can too.”

February 27, 2019

Spotlight on AOAC: New Leadership, New Initiatives In Cannabis & Food

By Aaron G. Biros

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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 Methods^SMfor 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 Methods^SMat 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 9^thannual 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.

AOAC INTERNATIONAL is working in a large variety of other areas as well. All of these topics will be explored in much greater detail at their upcoming 9^thannual 2019 Midyear Meeting, held March 11-14 in Gaithersburg, Maryland.

February 19, 2019

PerkinElmer Awarded Five Emerald Test Badges

By Aaron G. Biros

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According to a press release published today, Emerald Scientific awarded PerkinElmer five badges for The Emerald Test, a bi-annual Inter-Laboratory Comparison and Proficiency Test (ILC/PT) program. Awarding the badges for Perkin Elmer’s instruments and testing methods affirms their ability to accurately detect pesticides, heavy metals, residual solvents, terpenes and potency in cannabis.

According to Greg Sears, vice president and general manager of Food, Chromatography & Mass Spectrometry, Discovery & Analytical Solutions at PerkinElmer, they are the only instrument manufacturer to receive all five accolades. “To date, PerkinElmer is the only solutions provider to successfully complete these five Emerald Scientific proficiency tests,” says Sears. “The badges underscore our instruments’ ability to help cannabis labs meet the highest standards available in the industry and effectively address their biggest pain point: Navigating diverse regulations without compromising turnaround time.”

The instruments used were PerkinElmer’s QSight 220 and 420 Triple Quad systems, which are originally designed for accurate and fast detection/identification of “pesticides, mycotoxins and emerging contaminants in complex food, cannabis and environmental samples,” reads the press release. They also used their ICP-MS, GC/MS and HPLC systems for the badges.

PerkinElmer says they developed a single LC/MS/MS method using their QSight Triple Quad systems, which helps labs test for pesticides and mycotoxins under strict regulations in states like California and Oregon. They performed studies that also confirm their instruments can help meet Canada’s testing requirements, which set action limits nearly 10 times lower than California, according to the press release.

January 29, 2019

Pesticide Testing: Methods, Strategies & Sampling

By Charles Deibel

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Editor’s Note: The following is based on research and studies performed in their Santa Cruz Lab, with contributions from Mikhail Gadomski, Lab Manager, Ryan Maus, Technical Services Analyst, Dr. Laurie Post, Director of Food Safety & Compliance, Andy Sechler, Lab Director, Toby Astill, Senior Business Development Leader at Perkin Elmer and Charles Deibel, President of Deibel Cannabis Labs.

Pesticides represent the leading cause of batch failures in the cannabis industry. They are also the hardest tests to run in the laboratory, even one equipped with state-of-the-art equipment. The best instruments on the market are HPLC and GC dual mass spectrometer detectors, called “HPLC-qqq”, “GC-qqq,” or just triple quads.

As non-lab people, we envision a laboratory that can take a cannabis sample, inject it into a triple quad and have the machine quickly and effortlessly print out a report of pesticide values. Unfortunately, this is far from reality. The process is much more hands on and complex.In the current chemistry lab, trained analysts have to first program the triple quads to look for the pesticides of concern; in cannabis pesticide testing, this is done by programming the first of two mass spectrometers to identify a single (precursor) mass that is characteristic of the pesticide in question. For BCC requirements in California, this has to be done for all 66 pesticides, one at a time.

Next, these precursor ions are degraded into secondary chemicals called the “product” ions, also called transition ions. The second of the two mass spectrometers is used to analyze these transition ions. This process is graphed and the resulting spectrum is analyzed by trained chemists in the lab, pesticide by pesticide, for all the samples processed that day. If the lab analyzes 10 samples, that translates to 660 spectra to analyze (66 pesticides x 10 samples). When looking at the spectra for each pesticide, the analysts must compare the ratios of the precursor ions to the product ions.

Confirmation Testing

If these spectra indicate a given pesticide may be present, the chemists must then compare the ratios between the precursor and the products. If these ratios are not what is expected, then the analyst must perform confirmation testing to prove the precursor mass either is or is not the pesticide of concern. If the ratios are not what is expected, it means the molecule is similar to the pesticide in question, but may not be that pesticide. This confirmatory testing is key to producing accurate results and not failing batches when dealing with closely related chemicals. This process of analyzing spectra is done in all labs that are performing pesticide testing. In this fledgling industry, there are few published cannabis pesticide methods.

The need for this type of confirmation testing doesn’t happen all of the time, but when it does, it will take longer than our targeted three-day turn-around time. In the picture above, one precursor mass is ionized into several product masses; but only two are large enough to be used for comparison. In this hypothetical situation, two product masses are produced for every one precursor, the expected ion abundance ratio should be less than 30%. When performing any confirmatory testing, if the ion abundance ratio is >30%, it means the original precursor molecule was not the pesticide of concern. For example, if the ion abundance ratio was 50%, then the original molecule broke down into too many parts; it was not the pesticide we were looking for. This ion abundance ratio threshold was established by FANCO, the international organization that sets guidelines for all pesticide testing.

Testing Strategies

Methodology: In this fledgling industry, there are few published cannabis pesticide methods. The identification of the precursor mass and product ions are not always published, leaving labs to research which ions should be used. This adds to the potential for differences between lab results. Once selected, labs should validate their research, through a series of experiments to ensure the correct precursor and transition (product) ions are being used in the method.

Sample Preparation: Beyond the time-consuming work that is required to develop sound pesticide methods, the extraction step is absolutely critical for credible results. If the pesticides aren’t fully extracted from the cannabis product, then the results will be lower than expected. Sample preparations are often not standardized between labs, so unless a given extraction technique is validated for accuracy, there is the possibility for differences between labs.

Getting a Representative Sample

The current California recommended amount of sample is one gram of product per batch. Batch sizes can vary greatly and it is entirely likely that two different one gram samples can have two different results for pesticides. Has the entire plant been evenly coated with exactly the same amount of pesticide onto every square inch of its leaves? No, probably not. That is why it is imperative to take a “random” sample, by taking several smaller samples from different areas of the entire batch.

Sampling Plans: We can learn a lot from the manufacturing and sampling best practices developed by the food industry through the years. If a food manufacturer is concerned with the possibility of having a bacteria pathogen, like Salmonella, in their finished product, they test the samples coming off their production lines at a statistically relevant level. This practice (theory) is called the sampling plan and it can easily be adapted to the cannabis industry. The basic premise is that the more you test, the higher your likelihood of catching a contaminate. Envision a rectangular swimming pool, but instead of water, it’s filled with jello. In this gelatinous small pool, 100 pennies are suspended at varying levels. The pennies represent the contaminates.

Is the pool homogenized? Is jello evenly represented in the entire pool? Yes.

Is your concentrate evenly distributed in the extraction vessel? Yes. The question is, where are the pennies in that extraction vessel? The heavy metals, the microbial impurities and the pesticides should be evenly distributed in the extraction vessel but they may not be evenly represented in each sample that is collected. Unfortunately, this is the bane of the manufacturing industry and it’s the unfortunate reality in the food industry. If you take one random cup of jello, will you find the penny? Probably not. But it you take numerous 1 cup samples from random areas within the batch, you increase your chances of finding the contaminate. This is the best approach for sampling any cannabis product.

The best way to approve a batch of cannabis product is to take several random samples and composite them. But you may need to run several samples from this composite to truly understand what is in the batch. In the swimming pool example, if you take one teaspoon scoop, will you find one of the pennies? The best way to find one of the pennies is to take numerous random samples, composite them and increase the number of tests you perform at the lab. This should be done on any new vendor/cultivator you work with, in order to help establish the safety of the product.

January 16, 2019

Heavy Metals Testing: Methods, Strategies & Sampling

By Charles Deibel

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Editor’s Note: The following is based on research and studies performed in their Santa Cruz Lab, with contributions from Mikhail Gadomski, Lab Manager, Ryan Maus Technical Services Analyst, Laurie Post, Director of Food Safety & Compliance, and Charles Deibel, President Deibel Cannabis Labs.

Heavy metals are common environmental contaminants resulting from human industrial activities such as mining operations, industrial waste, automotive emissions, coal fired power plants and farm/house hold water run-off. They affect the water and soil, and become concentrated in plants, animals, pesticides and the sediments used to make fertilizers. They can also be present in low quality glass or plastic packaging materials that can leach into the final cannabis product upon contact. The inputs used by cultivators that can be contaminated with heavy metals include fertilizers, growing media, air, water and even the clone/plant itself.

The four heavy metals tested in the cannabis industry are lead, arsenic, mercury and cadmium. The California Bureau of Cannabis Control (BCC) mandates heavy metals testing for all three categories of cannabis products (inhalable cannabis, inhalable cannabis products and other cannabis and cannabis products) starting December 31, 2018. On an ongoing basis, we recommend cultivators test for the regulated heavy metals in R&D samples any time there are changes in a growing process including changes to growing media, cannabis strains, a water system or source, packaging materials and fertilizers or pesticides. Cultivators should test the soil, nutrient medium, water and any new clones or plants for heavy metals. Pre-qualifying a new packaging material supplier or a water source prior to use is a proactive approach that could bypass issues with finished product.

Testing Strategies

The best approach to heavy metal detection is the use of an instrument called an Inductively Coupled Plasma Mass Spectrometry (ICP-MS). There are many other instruments that can test for heavy metals, but in order to achieve the very low detection limits imposed by most states including California, the detector must be the ICP-MS. Prior to detection using ICP-MS, cannabis and cannabis related products go through a sample preparation stage consisting of some form of digestion to completely break down the complex matrix and extract the heavy metals for analysis. This two-step process is relatively fast and can be done in a single day, however, the instruments used to perform the digestion are usually the limiting step as the digesters run in a batch of 8-16 samples over a 2-hour period.

Only trace amounts of heavy metals are allowed by California’s BCC in cannabis and cannabis products. A highly sensitive detection system finds these trace amounts and also allows troubleshooting when a product is found to be out of specification.

For example, during the course of testing, we have seen lead levels exceed the BCC’s allowable limit of 0.5 ppm in resin from plastic vape cartridges. An investigation determined that the plastic used to make the vape cartridge was the source of the excessive lead levels. Even if a concentrate passes the limits at the time of sampling, the concern is that over time, the lead leached from the plastic into the resin, increasing the concentration of heavy metals to unsafe levels.

Getting a Representative Sample

The ability to detect trace levels of heavy metals is based on the sample size and how well the sample represents the entire batch. The current California recommended amount of sample is 1 gram of product per batch. Batch sizes can vary but cannot be larger than 50 pounds of flower. There is no upper limit to the batch sizes for other inhalable cannabis products (Category II).

It is entirely likely that two different 1 gram samples of flower can have two different results for heavy metals because of how small a sample is collected compared to an entire batch. In addition, has the entire plant evenly collected and concentrated the heavy metals into every square inch of it’s leaves? No, probably not. In fact, preliminary research in leafy greens shows that heavy metals are not evenly distributed in a plant. Results from soil testing can also be inconsistent due to clumping or granularity. Heavy metals are not equally distributed within a lot of soil and the one small sample that is taken may not represent the entire batch. That is why it is imperative to take a “random” sample by collecting several smaller samples from different areas of the entire batch, combining them, and taking a 1 g sample from this composite for analysis.

References

California Cannabis CPA. 12/18/2018. “What to Know About California’s Cannabis Testing Requirements”. https://www.californiacannabiscpa.com/blog/what-to-know-about-californias-cannabis-testing-requirements. Accessed January 10, 2019.

Citterio, S., A. Santagostino, P. Fumagalli, N. Prato, P. Ranalli and S. Sgorbati. 2003. Heavy metal tolerance and accumulation of Cd, Cr and Ni by Cannabis sativa L.. Plant and Soil 256: 243–252.

Handwerk, B. 2015. “Modern Marijuana Is Often Laced With Heavy Metals and Fungus.” Smithsonian.com. https://www.smithsonianmag.com/science-nature/modern-marijuana-more-potent-often-laced-heavy-metals-and-fungus-180954696/

Linger, P. J. Mussig, H. Fischer, J. Kobert. 2002. Industrial hemp (Cannabis sativa L.) growing on heavy metal contaminated soil: fibre quality and phytoremediation potential. Ind. Crops Prod. 11, 73–84.

McPartland, J. and K. J McKernan. 2017. “Contaminants of Concern in Cannabis: Microbes, Heavy Metals and Pesticides”. In: S. Chandra et al. (Eds.) Cannabis sativa L. – Botany and Biotechnology. Springer International Publishing AG. P. 466-467. https://www.researchgate.net/publication/318020615_Contaminants_of_Concern_in_Cannabis_Microbes_Heavy_Metals_and_Pesticides. Accessed January 10, 2019.

Sidhu, G.P.S. 2016. Heavy metal toxicity in soils: sources, remediation technologies and challenges. Adv Plants AgricRes. 5(1):445‒446.

January 9, 2019

Sequoia Analytical Labs Caught Falsifying Results

By Aaron G. Biros

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Last month, Sequoia Analytical Labs admitted that they falsified hundreds of pesticide tests for batches of cannabis products. The Sacramento-based laboratory faked data on 22 different pesticide tests for more than 700 batches over a period of four months.

According to a notice posted on Sequoia’s website, the skewed results were originally found due to a “faulty instrument” but “it was further discovered” that the lab director knew about it and was fraudulently posting the results in order to hand out certificates of analysis. The lab director in question has since been fired and Sequoia voluntarily relinquished their state license.

Joe Devlin, Sacramento’s chief of cannabis enforcement, told KCRA3 News “We’re going to be taking a look at suspending or possibly revoking their permit.” He followed that up with saying that California needs more testing labs. “The shortage of labs has really created a bottleneck in the supply chain across the state,” says Devlin. There are only 43 licensed laboratories in the state of California as of this time, and just three of those are in Sacramento.

The Bureau of Cannabis Control (BCC), the regulatory authority overseeing the cannabis testing market in California, has not commented on this story, but they did reach out to distributors who had sent batches to Sequoia for testing. “Any cannabis goods from these batches, returned by consumers to the retailer, must be destroyed,” reads the BCC letter. “Any cannabis goods returned from a retailer’s inventory or remaining in your inventory may be destroyed, or may be re-sampled and re-tested after obtaining approval from the Bureau. Any cannabis goods from these batches may not be released to a retailer without re-sampling and re-testing.”

Sequoia Analytical Labs posted two notices on their homepage, one was a letter to their clients informing them of the fraud and the other is that BCC letter to distributors doing the same. “Management and ownership were horrified to learn about this severe breach of a very important safety regulation,” reads the notice. “We have voluntarily surrendered our license to do COA testing to the BCC while we make the required corrections. We are already hard at work making the needed changes to the instrument and revamping procedures so that we may get our license reinstated January 1.”

As of today, the lab’s license has not been reinstated.

December 31, 2018

Deibel Cannabis Laboratories Launches Cannabis-Specific HACCP Program

By Dr. Laurie Post

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Manufacturers of cannabis products need a program tailored to the cannabis industry that helps assure the safety of cannabis products with respect to known hazards such as pesticides, residual solvents, microbial impurities, heavy metals and mycotoxins. Deibel Cannabis Laboratories has developed a course that that will teach those manufacturing cannabis products how to manage known product safety hazards using a Hazard Analysis and Critical Control Point (HACCP) system.

HACCP has a long history of use in the food industry based on preventing potential hazards from occurring rather than reacting to issues when they arise. This program was started in the US but is globally recognized, used by food companies around the world to help produce safe products for consumers. Deibel Cannabis Laboratories applies the same prevention based system of HACCP to the creation of safe and wholesome cannabis goods whether they be edible, medicinal or topical. They also explore ways cultivators can use HACCP principles in their operation.12

Deibel Labs was founded by Dr. Robert Deibel in the 1970’s. Dr. Deibel is one of the original pioneers of HACCP, expanding the program from its original three HACCP principles to the seven principles we recognize today. Dr. Deibel developed the first “HACCP Short Course,” teaching this prevention-based program to food industry leaders in the 1970s.

According to Charles Deibel, president of Deibel Labs, this is an important step for the cannabis space. “Deibel Labs is proud to continue in our historic role as leaders in HACCP training by providing the cannabis industry with a training course developed by Deibel Labs associates who are International HACCP Alliance accredited lead instructors with years of experience in crafting and implementing HACCP plans for the food industry.”

They are launching a pilot two-day Cannabis HACCP Class to select clients at the end of January in Santa Cruz, CA. The full Cannabis HACCP course schedule for 2019 is currently in development. Accreditation by the HACCP Alliance is expected by early January, assuring that a standardized and internationally recognized training curriculum is provided by accredited instructors.

The course is forward-thinking, anticipating that sometime in the near future cannabis manufacturers will be required to control and document the safe production, handling and preparation of products according to state or even federal regulatory standards. Participants will be able to develop their own model HACCP program in an interactive group learning environment.

Attendees will:

Understand how Prerequisite Programs provide the foundation on which HACCP programs are built including GMPs, Sanitation and Pest Control Programs
Be able to identify where and how product safety problems can occur using a Hazard Analysis that considers Biological, Chemical and Physical Hazards
Gain the skills, knowledge, and tools necessary to develop effective Critical Controls, formulate corrective actions, conduct program verification and validation activities
Learn how to document activities and maintain records

Stay tuned for more information on when the 2019 course schedule is announced and how to register.

November 19, 2018

EVIO Labs Florida Expands Operations

By Aaron G. Biros

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More than a year ago, we sat down with Chris Martinez, co-founder and chief operating officer of EVIO Labs Florida, when he just started getting the laboratory off the ground. In February of 2018, they became Florida’s first ISO accredited cannabis testing lab.

Fast-forward almost a year and EVIO Labs Florida is continuing their expansion in the state, now with locations in Broward County and Gainesville. “We are always looking at opportunities to better serve our clients and the patients of Florida,” says Martinez. “Opening Gainesville within a year of Davie was a goal we set for our team. We knew there was a need and opening Gainesville helped support the continued growth of FL medical marijuana program.” He says that between the two locations, they can now process upwards of 1,400 samples a day.

According to Martinez, much of that expanded throughput is thanks to their partnership with Shimadzu. “Our relationship with Shimadzu is very unique,” says Martinez. “Shimadzu instrumentation allows us to test in parts per billion for accuracy and sensitivity levels that empower us to see deep into the chemical makeup of these medicines. Operating in this space where speed and turnaround times are key, these instruments provide us with a platform to meet 24/48-hour deadlines.” They can now screen for contaminants such as pesticides, heavy metals, residual solvents, mycotoxins, aflatoxins and pathogens using instruments such as HPLC, GC-MS/MS, LC-MS/MS and ICP-MS, all provided by Shimadzu.

While Florida doesn’t currently have a final rule on testing thresholds, there are proposed regulations that would require independent lab testing for medical cannabis products. “Our clients are self-regulating at this time and in favor of the current proposed regulation,” says Martinez. “The proposed regulations will give Florida the most comprehensive and stringent testing regulation in the U.S. and arguably the world.”

For Martinez and the rest of the EVIO Labs Florida team, this is about protecting public health. “Our lab’s main focus is always first and foremost patient safety,” says Martinez. “As the market continues to grow, we continue to innovate through business intelligence software and other technologies to streamline the testing process for our customer’s.”

September 26, 2018

Massachusetts Regulators Crack Down On Pesticide Use

By Aaron G. Biros

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Earlier this month, the Massachusetts Department of Health sent a cease-and-desist letter to Good Chemistry, a Colorado-based brand operating in Massachusetts with a dispensary in Worcester and a cultivation facility in Bellingham. The letter claimed Good Chemistry used unapproved pesticides and must close their operations in the state.

goodchem.exter — A Good Chemistry dispensary in Colorado

According to a Boston Globe article, the company used three pesticides (approved for use on organic food products by the federal government) that cannabis regulators in Nevada, Oregon, Washington and Colorado have all approved for use in cannabis cultivation. Previously, Massachusetts has allowed a number of pesticides to be used on cannabis, but since last year when the state’s Department of Agricultural Resources took over regulating pesticide use on cannabis, they decided to ban all pesticides.

Representatives from Good Chemistry insist the compounds used were safe and that the state is singling them out when the practice is widespread in the industry. “These organic compounds are safe all over the country, and they’re safe in Massachusetts,” Jim Smith, a lawyer for Good Chemistry, tells the Boston Globe. “For the state to single out Good Chemistry for using an industry-standard practice is absolutely wrong. It’s not acceptable — and we’re not going to destroy the crop, because it poses no risk to public safety whatsoever.”

Good Chemistry even disclosed to the state that they would use those pesticides when they applied for a cannabis business license. According to Telegram.com, a local Worcester publication, Matthew Huron, chief executive officer of Good Chemistry, is asking the state to reverse their decision. “The Department of Public Health has the discretion to amend or rescind their order to allow us to make the cannabis we’ve cultivated available to patients in the Worcester community,” says Huron. “Patients have let us know that they really benefited from Good Chemistry’s wide selection of high quality cannabis strains, and they would like access to it again as soon as possible. We’ve asked the state to incorporate the research, analysis and experience that led other states like Colorado, Nevada, Washington and Oregon to determine that the use of these cultivation methods are best practices and helps create healthier, contaminant-free cannabis for patients and the industry as a whole.”

On September 5, the Department of Public Health allowed Good Chemistry to amend the cease-and-desist so they could sell products from other producers in the state. “Many of our patients rely on our medicine we grow specifically and we now are only allowed to sell third party product,” Huron told Telegram.com.