“By achieving ISO/IEC 17025 accreditation, TEQ Analytical Labs believes that we can address the concerns throughout the cannabis industry regarding insufficient and unreliable scientific analysis by providing our clients with state-required tests that are accredited by an international standard,” says Seth Wong, president of TEQ Analytical Laboratories. According to a TEQ Analytical press release, accreditation to this standard confirms that laboratories have the management, quality, and technical systems in place to ensure accurate and reliable analyses, as well as proper administrative processes to confirm that all aspects related to the sample, analysis and reporting are standardized, measured and monitored.
By implementing ISO 17025 accreditation, the laboratory monitors systems and processes central to analyses in an effort to minimize discrepancies and variability in test results. According to Roger Brauninger, biosafety program manager at A2LA, this type of accreditation demonstrates their competence and commitment to rigorous science. “It is encouraging to have testing laboratories taking ownership of the quality of the work performed,” says Brauninger. “Reliable testing will be imperative to insure safety of the products out on the market as this industry continues to expand.” As the first accreditation of its kind in North America, Brauninger hopes this will open the doors for more cannabis laboratories to acknowledge their role in demonstrating scientific competency for the industry.
Tripp Keber, president and chief executive officer of Dixie Brands, Inc., commends the achievement. “At Dixie Brands, we believe that cannabis is powerful, that quality is important, and that accurate dosing is of supreme importance,” says Keber. “Because Dixie is committed to delivering a safe, consistent, and accurately dosed product, lab testing is a vital component to our manufacturing processes.”
“TEQ’s achievement of ISO 17025 accreditation instills great confidence to Dixie Brands that our consumers’ health and safety is ensured and that they will enjoy a reliable and predictable experience with our product each and every time,” adds Keber. “Dixie’s strategic relationship with TEQ continues to build long-term brand value.” This kind of accreditation helps build trust in laboratories’ clients knowing they can provide accurate results repeatedly.
Despite the title, this article is not about weight loss – it is about generating valid analytical data for quantitative analyses. In the last installment of The Practical Chemist, I introduced instrument calibration and covered a few ways we can calibrate our instruments. Just because we have run several standards across a range of concentrations and plotted a curve using the resulting data, it does not mean our curve accurately represents our instrument’s response across that concentration range. In order to be able to claim that our calibration curve accurately represents our instrument response, we have to take a look at a couple of quality indicators for our curve data:
correlation coefficient (r) or coefficient of determination (r2)
back-calculated accuracy (reported as % error)
The r or r2 values that accompany our calibration curve are measurements of how closely our curve matches the data we have generated. The closer the values are to 1.00, the more accurately our curve represents our detector response. Generally, r values ≥0.995 and r2 values ≥ 0.990 are considered ‘good’. Figure 1 shows a few representative curves, their associated data, and r2 values (concentration and response units are arbitrary).
Figure 1: Representative Curves and r2 values
Let’s take a closer look at these curves:
Curve A: This represents a case where the curve perfectly matches the instrument data, meaning our calculated unknown values will be accurate across the entire calibration range.
Curve B: The r2 value is good and visually the curve matches most of the data points pretty well. However, if we look at our two highest calibration points, we can see that they do not match the trend for the rest of the data; the response values should be closer to 1250 and 2500. The fact that they are much lower than they should be could indicate that we are starting to overload our detector at higher calibration levels; we are putting more mass of analyte into the detector than it can reliably detect. This is a common problem when dealing with concentrated samples, so it can occur especially for potency analyses.
Curve C: We can see that although our r2 value is still okay, we are not detecting analytes as we should at the low end of our curve. In fact, at our lowest calibration level, the instrument is not detecting anything at all (0 response at the lowest point). This is a common problem with residual solvent and pesticide analyses where detection levels for some compounds like benzene are very low.
Curve D: It is a perfect example of our curve not representing our instrument response at all. A curve like this indicates a possible problem with the instrument or sample preparation.
So even if our curve looks good, we could be generating inaccurate results for some samples. This brings us to another measure of curve fitness: back-calculated accuracy (expressed as % error). This is an easy way to determine how accurate your results will be without performing a single additional run.
Back-calculated accuracy simply plugs the area values we obtained from our calibrators back into the calibration curve to see how well our curve will calculate these values in relation to the known value. We can do this by reprocessing our calibrators as unknowns or by hand. As an example, let’s back-calculate the concentration of our 500 level calibrator from Curve B. The formula for that curve is: y = 3.543x + 52.805. If we plug 1800 in for y and solve for x, we end up with a calculated concentration of 493. To calculate the error of our calculated value versus the true value, we can use the equation: % Error = [(calculated value – true value)/true value] * 100. This gives us a % error of -1.4%. Acceptable % error values are usually ±15 – 20% depending on analysis type. Let’s see what the % error values are for the curves shown in Figure 1.
Table 1: % Error for Back-Calculated Values for Curves A – D
Our % error values have told us what our r2 values could not. We knew Curve D was unacceptable, but now we can see that Curves B and C will yield inaccurate results for all but the highest levels of analyte – even though the results were skewed at opposite ends of the curves.
There are many more details regarding generating calibration curves and measuring their quality that I did not have room to mention here. Hopefully, these two articles have given you some tools to use in your lab to quickly and easily improve the quality of your data. If you would like to learn more about this topic or have any questions, please don’t hesitate to contact me at amanda.rigdon@restek.com.
Derek Peterson, chief executive officer of Terra Tech
Terra Tech, with the recent acquisition of Blum, a dispensary in Oakland, and the line of concentrates, IVXX, is sweeping the cannabis industry by setting standards for safety and quality. Terra Tech, publicly traded in theOver-The-Counter market, is well known as an agricultural company, with the subsidiary brand, Edible Garden, selling produce to Whole Foods, Wal-Mart and Kroger’s. In December of last year, we covered Terra Tech’s entrance into the cannabis marketplace and their experience with large-scale, sustainable agriculture. We sit down with Derek Peterson, chief executive officer of Terra Tech, to get an update on their progress and quality controls.
CannabisIndustryJournal: In January, Terra Tech announced revenue guidance of $20-22 million for 2016. Can you share some of your strategy going forward to meet your goals?
Terra Tech is taking organic and GFSI-certified agricultural practices to growing cannabis
Derek Peterson: We have always played both a long game as well as a short game, meaning while we are building our longer term business, like in Nevada, we are also focusing on short term accretive acquisitions, like we did with Blum in Oakland. We want to make sure we capture short-term revenue growth while we plan our future revenue production. We feel confident about achieving those results.
CIJ: How big of a role does the acquisition of Blum and IVXX brand expansion play in meeting those goals?
The Oakland location of Blum dispensary
Derek: Blum is a significant factor even though we are only capturing three quarters of revenue considering we closed the deal on March 31st of this year. So for the full year of 2017 we will have growth from this level considering we will be able to report a full year of Blum revenue. IVXX presents us with the best opportunity for growth in the coming years. As the market in California and Nevada grows we can continue to expand our IVXX footprint throughout the state. Being able to wholesale to thousands of other retail facilities affords us a significant opportunity to grow our sales.
CIJ: How do you think the brand of Edible Garden positions you well for expansion in the cannabis industry?
Produce ready for distribution at Edible Garden facility in Belvidere, New Jersey
Derek: One of the reasons we were so successful in the Nevada market was because regulators and legislators felt a high degree of confidence in our abilities considering we are USDA organic, Kosher and GFSI-certified. Our traditional agricultural experience has been very synergistic with our cannabis division from both an optics and operational perspective.
CIJ: Could you give us an update on progress in Medifarm LLC in Nevada? And on your distribution plan for IVXX in California?
IVXX concentrates
Derek: We are continuing to expand our IVXX line throughout the state and increasing our sales force. In addition we will continue to develop new products to distribute into our existing supply chain, like we just did with our new pre filled cartridge line.
We are opening our Decatur location in Las Vegas in early July and Reno and Desert Inn towards the end of August. Our cultivation and extraction facilities should be complete no later than January 2017. We will have our entire infrastructure in place if the recreational bill passes in Nevada this November.
Blum Las Vegas location will open in July
CIJ: Tell us about the role of laboratory testing in your business.
Derek: Laboratories play a significant role, as they are becoming a mandated step in most new legislation around the company. Independent lab testing is extremely important to maintain safe access for consumers and patients. We work primarily with Steep Hill Labs and CW analytics.
CIJ: Can you expand on your integrated pest management and your growing practices?
Platinum Cookies ready for packaging and labelling
Derek: Well we cannot say organic, however we do cultivate all naturally. We also cultivate traditional produce that we sell to major retailers. We are USDA organic-certified and we implement similar processes in our cannabis cultivation. Pest control is extremely challenging for any farmer but we rely primarily on bio control, meaning the good bugs eat the bad bugs. This has been very effective for us in the cultivation of all our products.
CIJ: How is your business different from the slew of other dispensaries and growers in California?
Consistency in quality standards requires meticulous SOPs
Derek: Service and consistency; we have over 42,000 registered patients and our operations team has over 19 years of experience in California. One of the reasons we have become one of the largest dispensaries in the state is because of that experience. In addition, consistency is extremely important. Consumers expect the same product in every other business and ours is no different. If they come in for our Platinum Cookies one month and the next month it has different characteristics you are going to lose patient confidence. So in the front of the house, we are focused on pairing patients’ needs with the correct product and in the back of the house we are focused on providing a meticulously cultivated product, produced at the highest standards.
CIJ: Can you delve into some of the processing for concentrates? How do you meet such rigorous quality standards?
Extraction equipment in one of the processing facilities for IVXX
Derek: Through research and development, we have engineered a proprietary process in which our solvent profiles used under our proprietary conditions ensures solvent residual levels which are not detected by instrumentation at 3rd party testing agencies such as Steep Hill Labs. In addition, any good scientific method requires repetition and corroboration of results. In order to accomplish this we also rely on random routine testing in which we send out extracts out to other 3rd party testing labs. Proprietary conditions include, but are not limited to, heat, vacuum, agitation, etc. By utilizing the correct amalgamation of solvent profiles, extraction conditions, purging conditions, as well as rigorous quality control standards, we are able to ensure a product that is void of any residual solvents, without sacrificing potency or identity of the cannabinoids and terpenes. Cannabinoids and terpenes are of chief interest when extracting cannabis for patients so that they have access to these essential oils without any of the actual leaf and bud.
All solvents used are the highest grade available to us, which ensures a truly medical product for the patient. In addition, all of our extraction equipment is routinely cleaned and sterilized using medical grade cleaning agents.
This column is devoted to helping cannabis analytical labs generate valid data right now with a relatively small amount of additional work. The topic for this article is instrument calibration – truly the foundation of all quality data. Calibration is the basis for all measurement, and it is absolutely necessary for quantitative cannabis analyses including potency, residual solvents, terpenes, and pesticides.
Just like a simple alarm clock, all analytical instruments – no matter how high-tech – will not function properly unless they are calibrated. When we set our alarm clock to 6AM, that alarm clock will sound reproducibly every 24 hours when it reads 6AM, but unless we set the correct current time on the clock based on some known reference, we can’t be sure when exactly the alarm will sound. Analytical instruments are the same. Unless we calibrate the instrument’s signal (the response) from the detector to a known amount of reference material, the instrument will not generate an accurate or valid result.
Without calibration, our result may be reproducible – just like in our alarm clock example – but the result will have no meaning unless the result is calibrated against a known reference. Every instrument that makes a quantitative measurement must be calibrated in order for that measurement to be valid. Luckily, the principle for calibration of chromatographic instruments is the same regardless of detector or technique (GC or LC).
Before we get into the details, I would like to introduce one key concept:
Every calibration curve for chromatographic analyses is expressed in terms of response and concentration. For every detector the relationship between analyte (e.g. a compound we’re analyzing) concentration and response is expressible mathematically – often a linear relationship.
Now that we’ve introduced the key concept behind calibration, let’s talk about the two most common and applicable calibration options.
Single Point Calibration
This is the simplest calibration option. Essentially, we run one known reference concentration (the calibrator) and calculate our sample concentrations based on this single point. Using this method, our curve is defined by two points: our single reference point, and zero. That gives us a nice, straight line defining the relationship between our instrument response and our analyte concentration all the way from zero to infinity. If only things were this easy. There are two fatal flaws of single point calibrations:
We assume a linear detector response across all possible concentrations
We assume at any concentration greater than zero, our response will be greater than zero
Assumption #1 is never true, and assumption #2 is rarely true. Generally, single point calibration curves are used to conduct pass/fail tests where there is a maximum limit for analytes (i.e. residual solvents or pesticide screening). Usually, quantitative values are not reported based on single point calibrations. Instead, reports are generated in relation to our calibrator, which is prepared at a known concentration relating to a regulatory limit, or the instrument’s LOD. Using this calibration method, we can accurately report that the sample contains less than or greater than the regulatory limit of an analyte, but we cannot report exactly how much of the analyte is present. So how can we extend the accuracy range of a calibration curve in order to report quantitative values? The answer to this question brings us to the other common type of calibration curve.
Multi-Point Calibration:
A multi-point calibration curve is the most common type used for quantitative analyses (e.g. analyses where we report a number). This type of curve contains several calibrators (at least 3) prepared over a range of concentrations. This gives us a calibration curve (sometimes a line) defined by several known references, which more accurately expresses the response/concentration relationship of our detector for that analyte. When preparing a multi-point calibration curve, we must be sure to bracket the expected concentration range of our analytes of interest, because once our sample response values move outside the calibration range, the results calculated from the curve are not generally considered quantitative.
The figure below illustrates both kinds of calibration curves, as well as their usable accuracy range:
This article provides an overview of the two most commonly used types of calibration curves, and discusses how they can be appropriately used to report data. There are two other important topics that were not covered in this article concerning calibration curves: 1) how can we tell whether or not our calibration curve is ‘good’ and 2) calibrations aren’t permanent – instruments must be periodically re-calibrated. In my next article, I’ll cover these two topics to round out our general discussion of calibration – the basis for all measurement. If you have any questions about this article or would like further details on the topic presented here, please feel free to contact me at amanda.rigdon@restek.com.
Kush Bottles, a packaging provider specific to the cannabis industry, recently launched the product BudGloves aimed at reducing the amount of human contact to cannabis products. The company is known for their child-resistant, regulatory compliant packaging.
The product BudGloves is the first glove of its kind engineered specifically for cannabis. The nitrile gloves do not contain any powder and are designed to prevent any transfer of resin, latex or powder to the cannabis. They are also slightly thicker than most other gloves to avoid getting caught or tearing, extending their life to withstand the typical shift of a trimmer or processor.
Nick Kovacevich, chief executive officer of Kush Bottles, wants to see a standard for preventing human contact with cannabis products to reduce the risk of contamination or loss in quality. Whether it is during cultivation, trimming, inspection, processing, transferring cannabis to instrumentation or even at the point of sale, it is important to minimize human contact to the cannabis.
“In California, we see bud tenders in dispensaries actually reach in a jar and grab cannabis to show the patient without gloves, which is a terrible standard operating procedure,” adds Kovacevich. “I would want all bud tenders to handle cannabis with gloves on.”
Particularly when handling food-grade products, most health code regulations require the use of gloves like these. According to Kovacevich, oils and extracts can be at a greater risk of contamination. “It is imperative that concentrates and extracts, especially those with activated THC, are handled with gloves to prevent any outside materials or contaminants from sticking to them,” says Kovacevich. The gloves are manufactured to meet stringent quality standards. To promote safety and quality of cannabis, reducing human contact with the product should be an important part of any company’s employee manual.
With the news of Pennsylvania’s medical cannabis legalization measure passing, lawmakers are clamoring for strict regulatory oversight in the form of traceability to prevent diversion and misuse. State Senator Daylin Leach (D- Montgomery/Delaware) introduced the bill and believes it will have the most intensive protections for safety in the country. “Our goal was to create a system that helps as many patients as possible, as soon as possible and as safely as possible,” says Steve Hoenstine, spokesperson for State Senator Leach. “The seed-to-sale tracking system and the bill’s other protections do just that.”
At the recent Cannabis Labs Conference, Cody Stiffler, vice president of government affairs at BioTrackTHC, discussed why traceability is so important. Stiffler previously served as the chief executive officer of the American Medical Management Association, where he fought the Florida prescription drug abuse epidemic. “We originally started tracking prescription medications and methamphetamine precursors to combat the prescription drug abuse and meth epidemic in Florida,” says Stiffler. He focused on providing accountability and traceability, making sure every prescription was legitimate and keeping drugs off the black market. Implementing tracking protocols allowed for the accountability of pharmacists, physicians and patients.
Cody Stiffler presenting at the Cannabis Labs Conference
The primary goals of a traceability system, according to Stiffler, are to prevent diversion and promote public safety. “We want to advance the cannabis industry with respect to traceability and regulatory compliance by integrating laboratory testing with traceability,” says Stiffler. “Our software helps get safe products to patients and consumers in a responsible manner.”
Stiffler’s role at BioTrackTHC is to provide industry insights to states looking to legalize cannabis and support them with identifying the best practices that meet requirements in their state. Traceability is commonly defined as the ability to verify history, location and application of a product from source to distribution. BioTrackTHC’s tracking software covers everything from seed to sale, involving regulatory bodies in oversight. In the beginning of cultivation, each plant is assigned a bar code or sixteen-digit identifier. According to Stiffler, Colorado’s system uses radio-frequency identification (RFID) tags while Washington’s system gives the business a choice because the software can work with any type of identifier, whether it is a barcode, QR code or RFID tag. “Our system generates those numbers and prevents diversion with a closed loop system,” says Stiffler.
A plant tagged with a barcode and date for tracking
Washington, Illinois, New York, New Mexico and Hawaii are the five states that use BioTrackTHC’s software. “If the state wants to see the chain-of-custody, they can go back in the system and see every touch point and the full life cycle of the product in real time,” says Stiffler. “Our system also incorporates lab testing to ensure no product reaches shelves unless test values are associated with it.”
A flowchart showing tracking from seed to sale.
For many states, problems lie not in diversion, but inversion, where black market growers bring their products into the legal market. “A lot of people growing black market product are inverting it into the regulated market,” notes Stiffler. This kind of black market activity can flood the legal market with un-tested cannabis.
Product recalls are examples of when traceability software can be very useful. Pesticides, microbiological contaminants, heavy metals and other contaminants are at issue. Stiffler invokes an example from a company in Washington making THC-infused drinks. “Because of an issue in the manufacturing process, the bottles were exploding in refrigerators and on shelves,” says Stiffler. “Because the product’s lineage was completely tracked, we could isolate all of the products in that specific batch from that specific manufacturer and then forward trace to every retailer that had it in inventory,” he adds. “Whenever someone who did not get the recall notice would attempt to scan that barcode at point of sale, a message appeared noting its recall status and that it is not for sale.” The software’s financial data analytics can provide real time visibility for profit margins or losses resulting from recalls.
According to Stiffler, these kinds of protections in place give law enforcement and government agencies piece of mind that they are helping to prevent diversion and promote public safety. Traceability software is one of the very important safeguards protecting food safety and product safety.
Just as industry experts have developed a set of tools to assess artisan experiences with wine, craft beer and diamonds, our team of cannabis cultivators at Good Chemistry Nurseries- who hold decades of experience backed by extensive education in horticulture and botany- have developed a new consumer guide to evaluate the essential aspects of cannabis called STATS (Sight, Touch, Aroma, Taste, Sensation). We hope the newly developed guide will begin an industry-wide dialogue about consumer education and provide fundamental knowledge on how to evaluate the quality of a cannabis flower.
A view of the materials for consumers
STATS was created in response to our customers’ growing desire to differentiate between high quality and low quality flower. Two years ago, a consumer may have walked into a dispensary, and may have been thrilled just to be able to buy legal and safe cannabis. Fast forward two years, and now they’re asking, “How do I recognize quality cannabis?” By introducing STATS as a consumer awareness campaign, we are hoping to meet the needs of consumers to understand the complexities of the cannabis flower, as well as opening up the industry to a more conservative market that might be overwhelmed and intimidated by the cannabis culture.
STATS, which is available at no cost at statsguide.org and at Good Chemistry dispensary locations, is designed as an interactive booklet that breaks down the complexities and characteristics of quality cannabis through the five main categories; sight, touch, aroma, taste and sensation. The short, easy-to-read tool also comes with a concise glossary, which includes definitions of cannabis-related words, and expressions that might not be palpable to a novice consumer. Here is an overview of the STATS tool to evaluate quality cannabis:
The STATS take away guide book for consumers
Sight:Seeing the flower can sometimes be the only evaluation option before purchase. It is important to know the visual cues for remarkable cannabis. STATS help consumers evaluate qualities including: trichome content, color, structure, size and trim.
Touch:Touching the flower can help with evaluating the cure, or the controlled drying process used to achieve proper moisture content post-harvest. STATS define how the bud should feel.
Aroma:Distinctions can be made between high and poor quality cannabis aroma. Because each flower strain can have a unique scent, STATS reviews what scents should be expected, and what smells can denote poor quality.
Taste:Different flowers strains will have unique flavor profiles. Similar to wine tasting, experience is necessary, STATS helps consumers learn to distinguish between different flavors among the flower strains.
The development team of STATS
Sensation:The first sensation that comes from cannabis is the sensation of lift, or of being high. Varying experience levels may affect how people feel with each strain and the amount of time people feel lifted. We have identified the key categories of sensations that come from different strains including amplify, relax, relieve, and sleep.
Now, there is an easy and free tool to provide novice and aficionado cannabis users new insight and understanding into the purchase they’re about to make. Good Chemistry Nurseries developed STATS in conjunction with our Colorado-based master cultivators Duncan Cameron, Scott Toland, Heath Byington and Stephen Spinosa. Our development team came to this idea with a strong desire to address consumers’ interest in learning more about how to assess high quality cannabis.
I have been working with the chemical analysis side of the cannabis industry for about six years, and I have seen tremendous scientific growth on the part of cannabis labs over that time. Based on conversations with labs and the presentations and forums held at cannabis analytical conferences, I have seen the cannabis analytical industry move from asking, “how do we do this analysis?” to asking “how do we do this analysis right?” This change of focus represents a milestone in the cannabis industry; it means the industry is growing up. Growing up is not always easy, and that is being reflected now in a new focus on understanding and addressing key issues such as pesticides in cannabis products, and asking important questions about how regulation of cannabis labs will occur.
While sometimes painful, growth is always good. To support this evolution, we are now focusing on the contribution that laboratories make to the safety of the cannabis consumer through the generation of quality data. Much of this focus has been on ensuring scientifically sound data through regulation. But Restek is neither a regulatory nor an accrediting body. Restek is dedicated to helping analytical chemists in all industries and regulatory environments produce scientifically sound data through education, technical support and expert advice regarding instrumentation and supplies. I have the privilege of supporting the cannabis analytical testing industry with this goal in mind, which is why I decided to write a regular column detailing simple ways analytical laboratories can improve the quality of their chromatographic data right now, in ways that are easy to implement and are cost effective.
Anyone with an instrument can perform chromatographic analysis and generate data. Even though results are generated, these results may not be valid. At the cannabis industry’s current state, no burden of proof is placed on the analytical laboratory regarding the validity of its results, and there are few gatekeepers between those results and the consumer who is making decisions based on them. Even though some chromatographic instruments are super fancy and expensive, the fact is that every chromatographic instrument – regardless of whether it costs ten thousand or a million dollars – is designed to spit out a number. It is up to the chemist to ensure that number is valid.
In the first couple of paragraphs of this article, I used terms to describe ‘good’ data like ‘scientifically-sound’ or ‘quality’, but at the end of the day, the definition of ‘good’ data is valid data. If you take the literal meaning, valid data is justifiable, logically correct data. Many of the laboratories I have had the pleasure of working with over the years are genuinely dedicated to the production of valid results, but they also need to minimize costs in order to remain competitive. The good news is that laboratories can generate valid scientific results without breaking the bank.
In each of my future articles, I will focus on one aspect of valid data generation, such as calibration and internal standards, explore it in practical detail and go over how that aspect can be applied to common cannabis analyses. The techniques I will be writing about are applied in many other industries, both regulated and non-regulated, so regardless of where the regulations in your state end up, you can already have a head start on the analytical portion of compliance. That means you have more time to focus on the inevitable paperwork portion of regulatory compliance – lucky you! Stay tuned for my next column on instrument calibration, which is the foundation for producing quality data. I think it will be the start of a really good series and I am looking forward to writing it.
In the first part of this series, I presented some issues with perpetual harvest models for cultivation with respect to inefficiencies in technology and environmental monitoring. I made the case for compartmentalizing cultivation facilities to not only increase energy efficiency, but also to mitigate contamination and control risks for pest incursions. In the second part of this series, I will elaborate on how compartmentalizing your facility can help you stay compliant with pesticide use regulations and promote worker safety.
Problems with Pesticide Use and Worker Safety Regulations
Where there are pests there are pesticides, whether they are low-toxicity materials derived from natural sources or chemical products that are illegal to use on cannabis. Even in the case of growers that are following current pesticide guidelines and using only products approved by their state department of agriculture, perpetual harvest models present issues in ensuring that the workplace is safe for employees and compliant with pesticide use regulations.
One obvious difficulty is the impossibility of containing drift from pesticides applied as foliar sprays. At this point, due to the lack of research performed on pesticides and cannabis, there are currently no defined pre-harvest intervals (PHI), even for products allowed for use on cannabis. A pesticide’s PHI is the number of days that must pass between the time of the last application of a pesticide and when the crop is cut for harvest. While no official, research-based PHIs have been outlined for pesticide use on cannabis, most conscientious cultivators refrain from spraying their crops with anything once flowers have emerged, as the resinous, sticky buds and their many crevices would presumably retain a great amount of any material applied to them. However, flowers do not generally emerge fully until the third week of the flowering process, and many growers apply preventative applications in the first two weeks of flower. In a perpetual harvest facility, what is to stop drift from applications made early in flower from contacting plants close to harvest? One could simply not spray in flower at all, but eliminating early-flower preventative treatments could increase the chances of a pest incursion, which, as discussed above, can be seemingly intractable in this type of facility.
It is important to consider the restricted entry interval (REI) when dealing with pesticide use. The REI of a pesticide is the period of time after an area is treated during which restrictions on entry are in effect to protect people from exposure to hazardous levels of pesticide residues. Most of the products and materials approved for use on cannabis in Colorado have no REI or a relatively short one. At the time I left my former facility, the longest REI for any product in use was twelve hours (for Evergreen Pyrethrum Concentrate), though most had REIs of four hours or less. This issue could be avoided in a perpetual harvest facility by simply always scheduling pesticide applications at the end of the workday; if a product is sprayed at 6 PM, for example, then the treated area should be safe for entry by the following morning when employees arrive. However, what is to be done if a pest incursion is discovered in the middle of the day and an immediate treatment is necessary to prevent its spread? Would the management or ownership of such a facility be willing to clear out the entire perpetual harvest area for 4-12 hours, potentially leaving other tasks unperformed or incomplete, so that a few plants could be sprayed? Even if operators went to such lengths to observe REIs properly, instances such as the hypothetical described above would create massive interruptions in daily workflows and scheduled tasks that are highly undesirable in a well-managed commercial setting. Compartmentalization allows for essential tasks in a single room that might need an emergency treatment to be completed in a timely manner, and cordoned off after the pesticide application to observe the REI.
A final point concerning this topic is that perpetual harvest facility designs make it difficult to observe certain requirements of the Worker Protection Standard (WPS). WPS is administered by the EPA (but is enforced by the Colorado Department of Agriculture (CDA) in that state) and consists of training intended to reduce the risk of pesticide poisoning and injury among agricultural workers and pesticide handlers. WPS training is required for all agricultural workers and pesticide handlers, including those in the legal cannabis industry. One requirement of WPS is that employers provide decontamination supplies for their employees in case of accidental pesticide exposure or poisoning. Sandra McDonald is a pesticide safety expert and owner of Mountain West PEST, which provides WPS and other training to farmers of all crops in Colorado. She states that decontamination supplies cannot be stored in areas that are to be or have been treated by pesticides (such as perpetual harvest rooms, for the purposes of this discussion), as the applications could possibly contaminate the decontamination supplies with pesticide residues, making them useless or even dangerous.
So, in a perpetual harvest facility, where does one store decontamination materials? Again, while there are solutions to this question, they are not ideal. The materials would of course have to be located outside the perpetual harvest room, the entirety of which is a “treated area” at one time or another. But, in facilities the size of the ones under discussion, it could be difficult for an employee who has been exposed to pesticides to reach an eyewash station if he or she has to navigate the expansive perpetual harvest room, as well as a doorway or two, in order to gain access to safety supplies located somewhere that pesticide contamination is not a risk. McDonald notes that most of the products approved for use on cannabis by the CDA would not require immediate decontamination. However, as not to downplay the very real risks posed by some approved products, she also points out that first aid statements on the labels of such pesticides recommend at least 15-20 minutes of continuous rinsing in the case of a worker getting pesticides in his or her eyes, and treatment that takes place sooner rather than later is obviously preferable. Additionally, there are some approved materials with high pH levels that could be immediately damaging if a worker splashed them in his or her eyes.
The issues raised by perpetual harvest designs in respect to pesticide use and worker safety are amplified greatly if businesses operating perpetual harvest facilities employ or have employed chemical pesticides that are illegal for use on cannabis. Unfortunately, the illegal application of restricted-use pesticides has revealed itself to be widespread, as examples from Colorado and Washington illustrate. One of the most commonly used illegal products, Eagle 20EW, carries with it a 24 hour REI. This means that to properly observe this safety measure, employees would be required to keep clear of the treated area for a full day, which I find unlikely to be enforced considering the daily requirements of a cultivation facility. Drift again poses a problem, but a much more serious one compared to the products on the CDA’s approved list.
Recommendations
It should be obvious by now that, when considering facility or site design, compartmentalization is desirable and necessary. This goes for greenhouse and outdoor production, as well as indoor. In fact, some outdoor farmers in the Emerald Triangle area of northern California work multiple, separate parcels to hedge against the threat of crop loss wiping out their entire year’s efforts. Though the discussion above focused mostly on flowering plants; propagation, vegetative, and mother areas should be separate as well, as they effectively contain all future harvests and are therefore of paramount importance.
The appropriate amount of compartmentalization will vary depending on the operation. In most agricultural businesses, some amount of loss is expected and incorporated into plans and budgets. In terms of areas for flowering plants, they should be compartmentalized to an extent that, should a severe infestation or systems failure occur, the loss of expected revenue from one or more rooms or areas will not cripple the business. Such loss should not happen often in a well-run, well-equipped facility. However, I have seen the drastic damage that russet mites can cause, in addition to experiencing the dread that permeates an entirely darkened warehouse after a transformer explosion, and would advise that cash flow projections take into account the possible loss of a harvest or two from a single room per year, just to be safe.
In cannabis farming, as in all agriculture, we must plan for the worst and hope for the best. Compartmentalization is a fundamental and effective safeguard against small pest incursions becoming widespread infestations, while allowing for grow areas to be fully sterilized and decontaminated after a harvest without completely interrupting all operations. It also allows for the observance of REIs, PHIs (even self-imposed ones), and certain WPS guidelines much more easily than perpetual harvest models. Finally, while costing more up front, ongoing operational expenses can be lessened, with a greater return on the energy that is used. While the benefits of wide-open spaces are frequently touted in a variety of contexts, cannabis cultivation is one where being boxed in is preferable to ensure that your employees, plants, and investment are protected.
Eurofins-Experchem Laboratories is a Health Canada and FDA-accredited analytical laboratory with a regulatory support division. The laboratory carries out testing for many different sectors including pharmaceuticals, cosmetics, natural health products and medical devices. Starting in 2014, cannabis testing was incorporated into the mix. One reason our results so accurate is due to rigorous staff orientation and training method. Diligent staff training and monitoring is very important for success as a Good Manufacturing Practices (GMP) facility with a Drug Establishment Licence and Narcotics License. So what does that look like on the inside? Saif Al-Dujaili, our quality assurance manager, Sohil Mana, our vice president of operations, and I will provide some guidelines for developing training programs below.
Introductory Session: When any new employee starts an introductory phase, it begins with general admin, a facility tour, policy manual training, govt. legislation overview and health and safety training and orientation (WHIMS and Bill 168) specific to our lab. We record signatures on any pertinent forms for SOPs that the new employee will be using.
Standard Operating Procedures: Any new employee must read all related SOPs and is evaluated on their understanding of them through questionnaires/quizzes. SOPs are written for all equipment, instrumentation or process that is applied in the lab, to ensure consistency across operations.
Laws and Regulations: New employees must be familiar or familiarized with Good Manufacturing Practices and Good Laboratory Practices. Analysts are required to read all sections of the USP pertinent to their role, as decided by the quality manager and/or dept. head and a checklist is recorded on training.
Methods: Different methods are used to test products including Compendium or other published methods with organizations such as the Association of Analytical Communities (AOAC) and the American Chemical Society (ACS). Client Methods and house-developed methods are also used. If there is a change to any method, a change control form must be filled out and documented.
Documentation: Documentation is very important in a GMP lab. All data is recorded in a hard cover bound book and/or approved worksheets. Quality assurance data reviewers are responsible for ensuring all data is being recorded properly.
Sample Management: Employees are trained on sample management related to sample entry, how samples are distributed to analysts, turn-around time, and where finished projects are placed.
Training Forms: Everything an employee learns must be recorded and filed for records. Analysts must follow a training matrix on qualitative and quantitative testing methods. Recurrent training occurs each 3 years or less depending on the position the analyst holds. Any updates on GMPs, new instruments or equipment is ongoing and recorded. Experchem runs “ghost” samples through its laboratory to ensure compliance by employees at any given time. Employees are evaluated on their abilities to comply.
Ongoing Training: Once employees are up and running they also receive monthly training in the lab and an annual GMP training followed by a comprehensive quiz that must be passed for them to continue work.
Interested in learning more about cannabis testing in Canada and the US? Contact Tegan Adams, business development manager with Eurofins at teganadams@eurofins.com.
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By implementing ISO 17025 accreditation, the laboratory monitors systems and processes central to analyses in an effort to minimize discrepancies and variability in test results. According to Roger Brauninger, biosafety program manager at A2LA, this type of accreditation demonstrates their competence and commitment to rigorous science. “It is encouraging to have testing laboratories taking ownership of the quality of the work performed,” says Brauninger. “Reliable testing will be imperative to insure safety of the products out on the market as this industry continues to expand.” As the first accreditation of its kind in North America, Brauninger hopes this will open the doors for more cannabis laboratories to acknowledge their role in demonstrating scientific competency for the industry.
