The Collaborative Laboratories for Environmental Analysis and Remediation (CLEAR) at the University of Texas at Arlington (UT-Arlington) and the University of Texas at El Paso (UT-El Paso) has begun collaborating with Curtis Mathes Grow Lights (CMGL), a subsidiary of the Curtis Mathes Corporation, and the hemp genetics company ZED Therapeutics. The research will involve characterizing the phytochemical effects of phytochrome manipulation using various LED horticultural lights of differing light spectrum, and novel high-yielding varietals of hemp. All of the hemp plants will be grown by renowned geneticists Adam Jacques, Christian West, and Oriah Love of ZED Therapeutics under the CMGL Harvester LED lights at their Oregon facility. Drs. Kevin Schug and Zacariah Hildenbrand will oversee the analysis of the corresponding samples for the expression of terpenes, flavonoids, and other classes of therapeutic compounds. The expression of 15 primary cannabinoid species will be performed concurrently by Matthew Spurlock of ZED Therapeutics.
“Since its inception, CLEAR has focused almost exclusively on improving environmental stewardship in the energy sector. It is nice to now diversify into the horticultural industry to better understand how chemically-diverse plants like hemp respond to different environmental-friendly LED lights,” says Professor Kevin Schug, Shimadzu Distinguished Professor of Analytical Chemistry and co-founder and the Director of CLEAR.
Hemp has recently garnered significant attention in the mainstream media as a result of the medicinal benefits of its primary natural constituent, CBD. The collaboration amongst UT-Arlington, UT-El Paso, CMGL and ZED Therapeutics is designed to better understand how the variable of light can influence the expression of other medicinal elements.
“We are incredibly excited about our growing collaborations with UT-Arlington, UT-El Paso, and ZED Therapeutics,” says CMGL’s COO, Robert Manes, “This particular research exploring phytochrome manipulation in hemp may unlock new lighting protocols whereby the modulation of different wavelengths is associated with the expression of different phytochemical profiles.”
This research also has the potential to discover novel molecules that may be present in the ZED Therapeutic hemp varietals using high-resolution exploratory instruments that are unique to the laboratories of CLEAR, such as Liquid Chromatography Quadrupole Time-of-Flight Mass Spectrometry (LC-QTOF-MS).
“We are always searching for new ways to expand our genetic catalogue and it will be interesting to see what sort of effects light modulation have on cannabinoid, terpene, and flavonoid expression,” says Adam Jacques of ZED Therapeutics, “Phytochrome manipulation, and any resulting epigenetic effects, is a poorly understood principle of horticulture and we see a significant opportunity with this research to unearth new knowledge.”
“Hemp is a unique plant both in its light spectrum adaptation and the wide range of phytochemicals it can potentially produce,” says Christian West of ZED Therapeutics, “I’ve been waiting my whole career to be a part of this research and having the lighting knowledge of CMGL combined with the analytical power of UT-Arlington and UT-El Paso is priceless in expanding our understanding of the plant.”
By Dr. Zacariah Hildenbrand, Dr. Kevin A. Schug No Comments
Much has been made about the plummeting market value of cannabis grown outdoors in Oregon. This certainly isn’t a reflection of the product quality within the marketplace, but more closely attributable to the oversaturation of producers in this space. This phenomenon has similarities to that of ‘Tulip Mania’ within the Dutch Golden Age, whereby tulip bulbs were highly coveted assets one day, and almost worthless the next. During times like these, it is very easy for industry professionals to become disheartened; however, from a scientific perspective, this current era in Oregon represents a tremendous opportunity for discovery and fundamental research.
Dr. Zacariah Hildenbrand, chief technical officer at Inform Environmental.
As we have mentioned in previous presentations and commentaries, our research group is interested in exploring the breadth of chemical constituents expressed in cannabis to discover novel molecules, to ultimately develop targeted therapies for a wide range of illnesses. Intrinsically, this research has significant societal implications, in addition to the potential financial benefits that can result from scientific discovery and the development of intellectual property. While conducting our experiments out of Arlington, Texas, where the study of cannabis is highly restricted, we have resorted to the closet genetic relative of cannabis, hops (Humulus lupulus), as a surrogate model of many of our experiments (Leghissa et al., 2018a). In doing so, we have developed a number of unique methods for the characterization of various cannabinoids and their metabolites (Leghissa et al., 2018b; Leghissa et al., 2018c). These experiments have been interesting and insightful; however, they pale in comparison to the research that could be done if we had unimpeded access to diverse strains of cannabis, as are present in Oregon. For example, gas chromatography-vacuum ultraviolet spectroscopy (GC-VUV) is a relatively new tool that has recently been proven to be an analytical powerhouse for the differentiation of various classes of terpene molecules (Qiu et al., 2017). In Arlington, TX, we have three such GC-VUV instruments at our disposal, more than any other research institution in the world, but we do not have access to appropriate samples for application of this technology. Similarly, on-line supercritical fluid extraction – supercritical fluid chromatography – mass spectrometry (SFE-SFC-MS) is another capability currently almost unique to our research group. Such an instrument exhibits extreme sensitivity, supports in situ extraction and analysis, and has a wide application range for potential determination of terpenes, cannabinoids, pesticides and other chemical compounds of interest on a single analytical platform. Efforts are needed to explore the power and use of this technology, but they are impeded based on current regulations.
Dr. Kevin A. Schug, Professor and the Shimadzu Distinguished Professor of Analytical Chemistry in the Department of Chemistry and Biochemistry at The University of Texas at Arlington (UTA)
Circling back, let’s consider the opportunities that lie within the abundance of available outdoor-grown cannabis in Oregon. Cannabis is extremely responsive to environmental conditions (i.e., lighting, water quality, nutrients, exposure to pest, etc.) with respect to cannabinoid and terpene expression. As such, outdoor-grown cannabis, despite the reduced market value, is incredibly unique from indoor-grown cannabis in terms of the spectrum of light to which it is exposed. Indoor lighting technologies have come a long way; full-spectrum LED systems can closely emulate the spectral distribution of photon usage in plants, also known as the McCree curve. Nonetheless, this is emulation and nothing is ever quite like the real thing (i.e., the Sun). This is to say that indoor lighting can certainly produce highly potent cannabis, which exhibits an incredibly robust cannabinoid/terpene profile; however, one also has to imagine that such lighting technologies are still missing numerous spectral wavelengths that, in a nascent field of study, could be triggering the expression of unknown molecules with unknown physiological functions in the human body. Herein lies the opportunity. If we can tap into the inherently collaborative nature of the cannabis industry, we can start analyzing unique plants, having been grown in unique environments, using unique instruments in a facilitative setting, to ultimately discover the medicine of the future. Who is with us?
References
Leghissa A, Hildenbrand ZL, Foss FW, Schug KA. Determination of cannabinoids from a surrogate hops matrix using multiple reaction monitoring gas chromatography with triple quadrupole mass spectrometry. J Sep Sci 2018a; 41: 459-468.
Leghissa A, Hildenbrand ZL, Schug KA. Determination of the metabolites of Δ9-Tetrahydrocannabinol using multiple reaction monitoring gas chromatography – triple quadrapole – mass spectrometry. Separation Science Plus 2018b; 1: 43-47.
Leghissa A, Smuts J, Changling Q, Hildenbrand ZL, Schug KA. Detection of cannabinoids and cannabinoid metabolites using gas chromatography-vacuum ultraviolet spectroscopy. Separation Science Plus 2018c; 1: 37-42.
Qiu C, Smuts J, Schug KA. Analysis of terpenes and turpentines using gas chromatography with vacuum ultraviolet detection. J Sep Sci 2017; 40: 869-877.
According to a press release, Digipath, Inc. (OTCQB: DIGP) was awarded a recreational cannabis-testing license and a renewal of their medical cannabis-testing license in Nevada.
Digipath Labs is based in Las Vegas, NV
The news came the week following Nevada’s opening day for recreational cannabis sales, which began July 1st. Some estimates report up to $5 million in sales within the first weekend.
Todd Denkin, founder and president of Digipath
According to Todd Denkin, president of Digipath, that massive start hasn’t showed any signs of slowing. “I was in a dispensary yesterday and it was packed,” says Denkin. “There were 40 people in line and it was pouring rain outside.” He says the flow of customers to dispensaries hasn’t stopped since July 1st.
Because of that demand as well as the state’s testing requirements, Denkin is preparing to expand. “From a laboratory’s perspective, we expect a large increase in volume,” says Denkin. “Most of the medical cultivators we work with got their rec license as well so we’re working with a lot of the same clients and getting new clients on a regular basis.” Before the launch of recreational sales, DigiPath has been doing lab testing for medical cannabis for over two years.
Cindy Orser, PhD., chief science officer at Digipath
Cindy Orser, PhD., chief science officer at Digipath, says they are on their way to receiving ISO 17025 accreditation via the American Association for Laboratory Accreditation (A2LA). According to Orser, labs in Nevada must go out and do the sampling themselves, then bring the samples back to the lab for testing. The testing regulations overall seem relatively similar to what we’ve seen develop in other states with required pesticide testing and microbial screening. “We have a list of 24 pesticides, (two of them are plant growth regulators) that we monitor for,” says Orser. “We have specific allowable limits for that set of chemicals.” For microbial testing, Orser says they enumerate total aerobic count (TAC), total yeast and mold (TYM), pathogenic E. coli and Salmonella spp., enterobacteriaceae and bile-tolerant gram-negative, a subset of enterobacteria, as well as screening for mycotoxins. All of the testing in the state goes through just eleven laboratories, including DigiPath.
In preparing for expansion, they are looking at California in addition to other states. California released a set of draft regulations for lab testing in the spring, which many say is an example of regulatory overreach. “We still don’t know exactly what’s going to happen in California,” says Orser. “The draft regulations that have come out are so restrictive.” As Digipath looks toward expanding more in Nevada, California and other states, all eyes are on regulators proposing requirements for laboratory testing. “The future looks promising,” says Denkin.
The Colorado Department of Public Health and Environment’s (CDPHE) Marijuana Laboratory Inspection Program issued a bulletin on January 30th regarding updates required for licensed cannabis testing labs. The updated method for microbial contaminant testing includes a longer incubation period in yeast and mold testing.
“After careful consideration of emerging data regarding the use and effectiveness of 3M Total Yeast and Mold Rapid Petrifilms in marijuana, CDPHE has concluded that 48 hours is not a sufficient incubation period to obtain accurate results,” the letter states. “Based upon the review of this information, marijuana/marijuana products require 60-72 hours of incubation as per the manufacturer’s product instructions for human food products, animal feed and environmental products.” The letter says they determined it was necessary to increase the incubation period based on data submitted from several labs, along with a paper found in the Journal of Food Protection.
An incubator (Right) at TEQ Analytical Labs
According to Alexandra Tudor, manager of the microbiology department at TEQ Analytical Labs (a cannabis testing lab in Aurora, CO), the update is absolutely necessary. “The incubation time extension requirement from CDPHE offers more reliable and robust data to clients by ruling out the possibility of a false yeast and mold result during analysis,” says Tudor.
Alexandra Tudor, microbiology department manager at TEQ Analytical Labs
“3M, the maker of Petrifilm, recommends an incubation time of 48-72 hours, but during TEQ’s method validation procedure, we learned that 48-hour incubation was not sufficient time to ensure accurate results. Although some laboratories in industry had been incubating for the minimum amount of time recommended by the manufacturer, the 48-hour incubation time does not provide a long enough window to ensure accurate detection of microbiological contaminants present in the sample.” Tudor says the update will help labs provide more confident results to clients, promoting public health sand safety.
As a result of the update in testing methodology, cultivators and infused product manufacturers in Colorado need to submit a batch test for yeast and mold. The point of requiring this batch test is to determine if the producer’s process validation is still effective, given the new yeast and mold testing method.
The Emerald Test advisory panel recently convened to review the results from the Fall 2016 round of the semi-annual Inter-Laboratory Comparison and Proficiency Test (ILC/PT), ahead of the third annual Emerald Conference just a few weeks away. After reviewing and analyzing the results, the panel noticed a significant improvement across the board over their Spring 2016 round of proficiency testing.
Emerald Scientific’s ILC/PT program is a tool laboratories use to check how accurate their testing capabilities are compared to other labs. A lab receiving The Emerald Test badge indicates their testing meets the criteria established by the panel to demonstrate competency. This means that they were within two standard deviations of the consensus mean for all analytes tested, according to Wes Burk, vice president of Emerald Scientific. He says the labs performed better than expected on both the microbial and pesticide tests.
Wes Burk, vice president of Emerald Scientific.
Each lab has access to raw, anonymized data including a consensus mean, z-scores and kernel density plots. This round measured how well 35 cannabis labs perform in testing for potency, pesticides, residual solvents and microbial contaminants such as E. coli, Salmonella, Coliform, yeast and mold.
The advisory panel includes: Robert Martin, Ph.D., founder of CW Analytical, Cynthia Ludwig, director of technical services at AOCS, Rodger Voelker, Ph.D., lab director, OG Analytical, Tammie Mussitsch, QA manager at RJ Lee Group, Shawn Kassner, senior scientist at Neptune & Company, Inc., Jim Roe, scientific director at Steep Hill Labs, Chris Hudalla, Ph.D., founder and chief scientific officer at ProVerde Labs, Sytze Elzinga, The Werc Shop and Amanda Rigdon, Chief Technical Officer at Emerald Scientific.
Amanda Rigdon, chief technical officer at Emerald Scientific
According to Amanda Rigdon, chief technical officer at Emerald Scientific, the labs performed very well in potency, residual solvents and microbial testing PTs. This is the first year the proficiency testing includes pesticides. “All of the labs did a great job identifying every pesticide in our hemp-based PT, but some more work will most likely have to be done to bring quantitative results in line,” says Rigdon. “Since this was the first pesticide PT we had offered, we were pretty conservative when choosing analytes and their levels. For the most part, analytes and levels were taken from the Oregon pesticide list, which is widely recognized to be the most reasonable and applicable pesticide list out there to date.” They covered pesticides of high concern, like abamectin and Myclobutanil, but also included a wide range of other pesticides that labs are expected to encounter.
Shawn Kassner, senior scientist at Neptune & Company, Inc.
Shawn Kassner, senior scientist at Neptune & Company, Inc., believes microbial contamination proficiency testing should be a priority for improving public health and safety going forward. Although five participating labs did not receive badges for the microbial contamination PTs, panel members say the overall performance was really quite good. “Microbiology testing are essential analyses for all cannabis products and it’s just slower in regulatory implementation than potency testing,” says Kassner. “The risk of Salmonella and E. coli to an individual using a medical cannabis product could be very life threatening. Microbiology contamination is a huge concern for any public health agency, which is why we have seen that microbiology testing is usually the first analytical test required after potency.” Kassner notes that there were few outliers and with each Emerald PT program, he is seeing an improvement in overall laboratory performance.
For The Emerald Test’s next round, the panel hopes to make some improvements in the test’s robustness and consistency, like obtaining assigned values for all samples and comparing to a consensus mean. “We want to develop permanent badge criteria, streamline the appeals process and possibly implement a qualitative performance review in the pesticide PT,” says Burk. For the next round of pesticide PTs, they want to build a better list of pesticides to cover more states, allowing labs to pick a set based on their state’s regulations. Burk says they also want to collect data on whether or not matrix-matched curves were used for pesticides.
Rodger Voelker, Cynthia Ludwig and Shawn Kassner, all members of the advisory panel, will be speaking at the Emerald Conference, discussing some of their findings from this round of proficiency testing. The Emerald Conference will take place February 2nd and 3rd in San Diego, CA.
Dr. Zacariah Hildenbrand, chief scientific officer and partner at C4 Laboratories, is currently researching some of the lesser-known molecules in cannabis, and he’s on to something. His research focuses on discovering new molecules, determining their therapeutic effects and expanding our understanding of the constituents of cannabis.
Dr. Zacariah Hildenbrand, chief scientific officer and partner at C4 Laboratories.
Dr. Hildenbrand received his Ph.D. from the University of Texas at El Paso where he researched the molecular architecture involved in hormone-dependent cancers. At the University of Texas Southwestern Medical Center in Dallas, his post-doctoral research contributed to the development of a novel therapy for the treatment of chronic myeloid leukemia, a blood-borne cancer that afflicts small children. He has published over 25 peer-reviewed scientific journal articles and hopes to do the same with his research in cannabis.
After a career of scientific consulting, Dr. Hildenbrand met Ryan Treacy, founder and chief executive officer of C4 Laboratories, in 2015 when Treacy launched the company. In June of 2015, the laboratory began operations, providing Dr. Hildenbrand the opportunity to embark on a new and exciting field of research- cannabis.
Ryan Treacy, founder and chief executive officer at C4 Laboratories.
They currently collaborate with Dr. Kevin Schug of the Shimadzu Center for Advanced Analytical Chemistry (SCAAC) at the University of Texas, Arlington and together Drs. Schug and Hildenbrand are pursuing a DEA license to expand their current cannabis research. The SCAAC is a $10.0+ million analytical laboratory with instrumentation that only a handful of people in the world has access to.
C4 Laboratories, based in Mesa, Arizona, currently offers a range of services for cannabis analysis including terpene and cannabinoid analytics, microbial, pesticide, fungicide and insecticide testing. In addition to the standard gamut of tests, they also specialize in cultivation analytics like mold and mildew culture testing, viral detection with sentinel plants and comprehensive analysis of environmental conditions.
What makes their company unique is their multidisciplinary effort to characterize the therapeutic compounds found in cannabis, the C4 Cannabinomics Collaborative. We sit down with Dr. Zac Hildenbrand to talk cannabis science, his research and what they hope to accomplish with the C4 Cannabinomics Collaborative.
CannabisIndustryJournal: What is the C4 Cannabinomics Collaborative?
Dr. Zacariah Hildenbrand: The C4 Cannabinomics Collaborative is an open collaboration between growers and scientists to discover new molecules in cannabis and to have a better characterization of individual cannabis strains based on the active constituents found in each sample. We are facilitating the collaboration of some of the world’s best cannabis growers with world-class scientists to find new information about the plant.
What we want to accomplish in this work is identifying novel molecules. Because of the [federal government’s] restrictions in researching cannabis, there is very little peer-reviewed literature on many of the compounds found in cannabis. We want to secondarily find out what those molecules do in the human body and thus make recommendations for strains targeting specific conditions.
We also want to understand the strains currently out there by determining the most established cannabinoids and terpenes via chemotyping. You hear a lot of people talking about the effects of an Indica or Sativa and making recommendations based on that. We want to find chemical signatures based on cannabinoids and terpenes and make recommendations based on that. There are a lot of problems at hand when discussing strain names scientifically. There are nomenclature issues- people calling the same strain different names, people giving multiple names to the same strain to make it appear that their strain portfolios are more diverse.
We can identify the chemical signatures in strains based on the major cannabinoids and terpenes. Based on the terpenes and chemical profile we can determine more accurate recommendations for patients as well as in recreational applications. All of this, again, discovering the new molecules, identifying the current strains, is so we can make more informed decisions regarding cannabis use. It is not a panacea but it is a very robust plant. There are a lot of terpenes with anti-inflammatory responses. Other molecules help with blood flow, sleep, regulating blood glucose, and we all know the cases of CBD helping children with convulsions and epilepsy. We want people to make sure they have the most up-to-date information.
CIJ: How is your collaboration with the SCAAC at UT Arlington contributing to this work?
Dr. Hildenbrand: One of the instruments we use there is a supercritical-fluid-extraction supercritical-fluid-chromatography mass-spectrometer (SFE-SFC-MS). With that instrument, we can do the extraction on the machine with an extreme level of sensitivity. It is ideal for drug discovery and identifying molecules in the parts-per-quadrillion range. This particular instrument allows us to detect molecules with an extreme level of sensitivity without volatizing them during the sample extraction process.
The Shimadzu Center for Advanced Analytical Chemistry
We want to acquire samples of unique cannabis from growers that will work with us to discover new cannabis constituents. We are in the process of getting a DEA license so that we can send products across state lines to the center at UT Arlington to perform the advanced characterization. They have instrumentation that only a handful of people in the world have access to, which gives us the best opportunity to explore the unknown. When we discover new molecules, find out what they do on the molecular level, we can then isolate these compounds and ultimately use this newfound knowledge for the development of effective nutraceuticals.
CIJ: What molecules are you researching right now?
Dr. Hildenbrand: Some of the low-hanging fruit in our research looks at identifying compounds similar to the better-studied compounds such as THC and CBD. THCV has a very similar structure to THC, but has a shorter acyl carbon chain (3 carbons vs. 5).
Tetrahydrocannabivarin (THCV)
THCV doesn’t induce a psychoactive response (like THC), but it does improve fat utilization, so it has remarkable potential for medicine. We are looking at what conditions are required for it to occur naturally. Cannabis doesn’t produce THCV in a high amount. 0.7% by weight is the most we have seen in Arizona. In Oregon, where craft cannabis has been refined to a much higher degree, we have heard rumblings of some strains containing up to 3% THCV. We want to find out if this is a possible weight loss tool. Our research in CBDV is very much the same.
CBL is the breakdown product of CBC when it is treated with ultraviolet light. We know absolutely nothing about what CBL does. If we find a strain that produces high amounts of CBC, we can then treat it with UV light and force the conversion to CBL, and then ultimately determine what it does. This is a good example of low-hanging fruit and the versatility of cannabis. Based on the biogenesis of the cannabinoids, we can alter the profile of cannabis products using a series of biochemical reactions.
Cannabicyclol (CBL)
For example, we have been helping clients in Arizona look for a quality sleep aid in cannabis. Certainly, Indica strains will help, but the molecule CBN helps specifically with sleep abnormalities. As CBN is formed as a byproduct when CBD or THC are oxidized, we see some producers using liquid nitrogen to oxidize CBD, leading to higher CBN levels. I would like to think we are in the age of understanding CBD, THC and the major terpenes,but there are a whole milieu of compounds that require our attention and THCV, CBDV and CBL are just a few that we want to devote our efforts to right away.
CIJ: What are your plans in the immediate future?
Dr. Hildenbrand: We are in the process of finalizing the documents to bring a C4 laboratory into Oregon where we can do quite a bit of research and where we’ll have access to some very unique cannabis. We will offer full compliance testing per ORELAP and OLCC regulations, but we also want to acquire samples (free of charge) from growers that want to collaborate with us to discover new molecules. We’ve been lucky enough to start working with growers like Adam Jacques and Chris West in Eugene, but we also want to be available to other growers who want to contribute to this research.
CIJ: What are your long-term goals with this project?
Dr. Hildenbrand: At a basic level, we hope to expand the current understanding of the cannabis plant. There is a lot of “bro science” and anecdotal claims out there. There is so much that we don’t know about cannabis that we cannot simply rely on anecdotal claims for each strain. We want to bring cannabis into the same light as any pharmaceutical-grade or biomedical research.
We need to be characterizing this plant with the same level of detail as other pertinent molecular therapies. In doing so there are a lot of potential discoveries to be made and we might be able to unlock the future of medicine. A drug like Marinol, for example, has been met with mixed reviews because its only one dimensional. Furthermore, we find that the terpene molecules are tremendously beneficial and this interplay between cannabinoids and terpenes is something that we want to explore further. All and all we wish to further illustrate the therapeutic capacities of cannabis within the contexts of specific ailments and medical conditions, while discovering the medicine of the future.
Three health alerts were issued Thursday, November 4th for contaminated cannabis sold to consumers at North Bend, Salem and Eugene dispensaries. Green-Way Medicinal in Salem and Stonies in North Bend sold two strains of cannabis flower found to have high levels of piperonyl butoxide, an ingredient commonly found in pesticides that acts as a synergist to amplify the effects of certain compounds.
The two batches in question, including the strains Pleeze (batch number G6J0039-02) and Dryzl (batch number G6J0039-01), were found to contain the potentially dangerous chemical at levels of 15.39 ppm and 16.24 ppm, respectively. The Oregon Health Authority (OHA) action level for piperonyl butoxide is 2.0 ppm. To see the full health alert, click here.
The dispensary in Eugene, Flowr of Lyfe, sold one strain of cannabis that had levels of the insecticide spinosad over the 0.2-ppm action level. The very popular indica hybrid, Dutch Treat (batch number G6J0018-01), was found to contain 0.9-ppm of spinosad. Though it still tested above the 0.2-ppm action level for that insecticide, it pales in comparison to October’s health alert, where a batch of cannabis had over 200 times the acceptable level of that insecticide. Both spinosad and piperonyl butoxide are considered toxic to humans.
According to the health alert, “All tests were performed by an OHA-accredited and Oregon Liquor Control Commission-licensed laboratory.” It is unclear exactly how or why the cannabis was able to get transported and transferred from the grower to the dispensary and then sold to consumers after failing the pesticide test. According to Jonathan Modie, spokesman for the OHA, they are currently investigating the matter and following up with the dispensaries and growers to find out what happened. “We need to find out how this got transferred in the first place and then sold,” says Modie. “They had access to the test results and should have been able to determine for themselves that these products should not have been sold or transferred.”
“We don’t know, we are still gathering information, there is a risk of civil penalty as well as losing your registration for a dispensary or grower that illegally transferred products that have tested for analytes above the action levels,” says Modie, when asked if punitive measures would be taken. While there are no particular regulations for this scenario in performing a mandatory recall, the OHA is obligated under law to issue health alerts when there is a situation that might affect public health, according to Modie.
“We deal with this with infectious disease outbreaks or during a food borne illness outbreak; if they [the public] can avoid it by hearing from us then we want to get the word out and this is a very similar situation.” For medical patients that purchase potentially contaminated cannabis such as this, it is easy to contact them to have the patient dispose or return the cannabis. Dispensaries are not required to collect information from recreational customers, and most dispensaries do not, which is a major problem when this situation happens, as it has twice in the past two weeks.
“We can never do too much communication,” says Modie. “We will let the public know in any way possible that they should return this product or dispose of it responsibly.”
This is the first piece of a regular column that CIJ has been so kind to allow me to write for their publication. Some readers might recognize my name from The Practical Chemist column in this publication. Since the inception of that column, I’ve finally taken the plunge into the cannabis industry as chief technical officer of Emerald Scientific. Unlike The Practical Chemist, I will not spend the entire first article introducing the column. The concept is simple: while I find the textbook-esque content of The Practical Chemist scintillating, I have a feeling that the content is a little too heavy to spring on someone who is looking for engaging articles over their precious coffee break. Instead, The Nerd Perspective will consist of less-technical writing focusing on my experience and insights for the cannabis industry as a whole. But don’t worry – I’m sure I will not be able to refrain from technical jargon altogether.
To kick off the column, I want to talk about instrumentation for ‘instant’ cannabis potency testing. At this point, it’s common knowledge in the cannabis analytics industry that the most accurate way to test cannabis potency is through extraction then analysis by HPLC-UV. I agree wholeheartedly with that sentiment, but HPLC analyses have one drawback: they can be either inexpensive or fast – not both. There are some instruments entering the market now that– while not as directly quantitative as HPLC-UV – promise to solve the inexpensive/fast conundrum. During my most recent trip to California, I was able to spend some quality time with two well-known instrument manufacturers: SRI Instruments and PerkinElmer, both of whom manufacture instruments that perform fast, inexpensive cannabis potency analyses. From my previous home at the heights of The Ivory Tower of Chromatography: Home of the Application Chemists, SRI and PE couldn’t be more different. But as seen through the eyes of a company who deals with a wide range of customers and analytical needs, it turns out that SRI and PE are much the same – not only in their open and honest support of the cannabis industry, but also in terms of their love of all things technical.
My first stop was SRI Instruments. They are a relatively small company located in an unassuming building in Torrance, CA. Only a few people work in that location, and I spent my time with Hugh Goldsmith (chief executive officer) and Greg Benedict (tech service guru). I have worked with these guys for a few years now, and since the beginning, I have lovingly referred to them as the MacGyvers of chromatography. Anyone familiar with SRI GCs knows that what they lack in aesthetics, they make up for in practicality – these instruments truly reflect Hugh and Greg’s character (that’s meant as a compliment).
SRI specializes in relatively inexpensive portable and semi-portable instruments that are easy to set up, easy to operate, and most importantly – engineered for a purpose. It’s actually really hard to manufacture an instrument that meets all three of these criteria, and the folks at SRI accomplish this with their passionate and unique approach to problem solving. What I love about these guys is that for them, nothing is impossible. Here’s an example: the price of the portable GC-FID instruments SRI builds is inflated because the instruments require separate – and pricey – hydrogen generators. That’s a big problem – hydrogen generators are all pretty much the same, and none of them are cheap. This didn’t faze SRI: they just decided to design their own super small on-board hydrogen generator capable of supplying hydrogen to a simple GC system for six hours with just 20mL of distilled water from the grocery store! I’m not kidding – I saw it in action on their new Model 420 GC (more on that in some future pieces). Was the final product pretty? Not in the least. Did it work? Absolutely. This kind of MacGyver-esque problem solving can only be done successfully with a deep understanding of the core principles behind the problem. What’s more, in order to engineer instruments like these, SRI has to have mastery over the core principles of not only chromatographic separation, but also of software development, electrical engineering, and mechanical engineering – just to name a few. These quirky, unassuming guys are smart. SRI is a company that’s been unapologetically true to themselves for decades; they’ll never be a contender for beauty queen, but they get the job done.
On the surface, PerkinElmer (PE) contrasts with SRI in almost every way possible. With revenue measured in billions of dollars and employees numbering in the thousands, PE is a behemoth that plays not only in the analytical chemistry industry but also in clinical diagnostics and other large industries. Where SRI instruments have a characteristic look of familiar homeliness, PE instruments are sleek and sexy. However, PerkinElmer and SRI are more alike than it would seem; just like the no-frills SRI, the hyper-technical PE instruments are engineered for a purpose by teams of very smart, passionate people.
With its modest price tag and manual sample introduction, the SRI Model 420 is engineered for lower throughput users to be a fast, simple, and inexpensive approach to semi-quantitative process control. The purpose of the instruments manufactured by PE is to produce the highest-quality quantitative results as quickly as possible for high-throughput labs. PE instruments are built using the best technology available in order to eke out every last ounce of quantitative accuracy and throughput possible. Fancy technology is rarely inexpensive, and neither is rigorous product development that can last years in some cases. In a way, PE is Doogie Howser to SRI’s MacGyver. Like MacGyver, Doogie is super smart, and his setting is a sterile hospital rather than a warzone.
I had a wonderful conversation with Tim Ruppel, PE’s headspace-GC specialist, on the sample introduction technology incorporated into the TurboMatrix Headspace Sampler, where I also learned that the basic technology for all PerkinElmer headspace-GC instruments was designed by the men who wrote The Book on headspace gas chromatography: Bruno Kolb and Leslie Ettre**. Later, I was able to get a much-needed lesson on FT-IR and the Spectrum Two IR Spectrometer from Brian Smith, PE’s spectroscopy expert, who actually wrote the book on quantitative spectroscopy***. Tim and Brian’s excitement over their technology mirrored that of Hugh and Greg. It turns out that SRI and PerkinElmer are more alike than I thought.
These two instrument manufacturers have addressed the fast/inexpensive conundrum of cannabis potency testing in two different ways: SRI’s instrument is extremely inexpensive, easy to operate, and will provide semi-quantitative values for THC, CBD, and CBN in just a few minutes; PE’s instrument is more expensive up front, but provides quantitative (though not directly quantitative) values for all of the major cannabinoids almost instantly, and requires almost no maintenance or consumables. These two instruments were designed for specific uses: one for inexpensive, easy use, and the other for more comprehensive results with a higher initial investment. The question consumers have to ask themselves is “Who do I need to solve my problem?” For some, the answer will be MacGyver, and for others, Doogie Howser will provide the solution – after all, both are heroes.
** B. Kolb, L. Ettre, Static Headspace-Gas Chromatography: Theory and Practice, John Wiley & Sons, Hoboken, NJ, 2006.
*** Brian C. Smith, Quantitative Spectroscopy: Theory and Practice, Elsevier, Boston, MA, 2002.
Emerald Scientific, a supplier of reagents, supplies, equipment and services to cannabis testing and extraction facilities, recently named Amanda Rigdon as the company’s chief technology officer. Rigdon previously worked at Restek Corporation, a manufacturer of chromatography supplies, as an applications chemist and a member of their gas chromatography columns product marketing team.
Amanda Rigdon, chief technology officer at Emerald Scientific
Before working in the cannabis space, Rigdon began her career in the pharmaceutical and clinical/forensics industries. She spent seven years in Restek’s applications lab where she was responsible for the development and application of chromatography products for the pharmaceutical and clinical/forensics arenas. In recent years, she has been an outspoken advocate in the science of cannabis while with Restek.
As a strong proponent for scientific progress in cannabis, she brings extensive technical expertise and marketing experience related to cannabis testing and research. Presenting at numerous cannabis science conferences and seminars, she regularly provides education on analytical methods and best practices in the lab.
As a contributing author to CannabisIndustryJournal.com and member of the editorial advisory board, she writes a column addressing challenges in the lab and providing technical advice. “I’m thrilled to be a part of the Emerald Scientific team and a member of the cannabis community as a whole,” says Rigdon. “I’ve known the folks at Emerald [Scientific] for years; they’re among the best in the business, and they’ve been supporting the cannabis community since the early days of cannabis analytics.” Rigdon’s mantra in the cannabis testing space has long been to support sound science in the interest of protecting patient and consumer health.
“I’m really looking forward to using my technical skills in conjunction with Emerald’s position and reach in the market to make work easier for cannabis labs through education, applications and new products,” adds Rigdon. Emerald Scientific is widely known in the cannabis testing community for The Emerald Test, an inter- laboratory comparison proficiency test, organized twice per year. It also hosts The Emerald Conference, an annual scientific meeting for scientists, policy makers, producers, and other key members of the cannabis industry. ˇThe Emerald Conference is the first scientifically focused conference for the cannabis industry, now coming up on its third annual conference in February 2017.
The American Association for Laboratory Accreditation (A2LA) and Americans for Safe Access (ASA) announced yesterday a collaboration to develop a cannabis-specific laboratory accreditation program based upon the requirements of ISO/IEC 17025 and ASA’ s Patient Focused Certification (PFC) Program. Accreditation under this program will offer the highest level of recognition and provide the most value to the laboratory and users of the products tested, according to a press release published yesterday. ASA is the largest medical cannabis patient advocacy group in the United States. “A2LA is pleased to partner with ASA to offer a cannabis testing laboratory accreditation program to ISO/IEC 17025 as well as the additional laboratory requirements from ASA’s Patient Focused Certification Program,” says Roger Brauninger, biosafety program manager at A2LA.
Pictured left to right: Kristin Nevedal, Program Manager, PFC at ASA; Jahan Marcu, Ph.D Chief Scientist, PFC at ASA; Roger Brauninger, BioSafety Program Manager, A2LA; Michelle Bradac, Senior Accreditation Officer, A2LA
The program affirms that cannabis laboratories are compliant with state and local regulations and ensures that they adhere to the same standards that are followed by laboratories used and inspected by the Environmental Protection Agency (EPA), the United States Department of Agriculture (USDA), and the U.S. Consumer Product Safety Commission (CPSC) among other regulatory bodies. The two non-profit organizations will offer their first joint training course at A2LA’s headquarters in Maryland from July 11th to the 15th. During this course, participants will receive training on PFC’s national standards for the cultivation, manufacture, dispensing, and testing of cannabis and cannabis products, combined with ISO/IEC 17025 training.
The guidelines for cannabis operations that serve as the basis for this accreditation program were issued by the American Herbal Products Association (AHPA) Cannabis Committee, an industry stakeholder panel, and have already been adopted by sixteen states. “We are very excited to see the PFC program join the ISO/IEC 17025 accreditation efforts to help fully establish a robust and reliable cannabis testing foundation,” says Jeffrey Raber, chief executive officer of The Werc Shop, a PFC-certified cannabis testing laboratory. “It is a great testament to ASA’s commitment to quality in their PFC program by partnering with a world-renowned accrediting body to set a new standard for cannabis testing labs.”
According to Kristin Nevedal, program director of PFC, this is an important first in the industry. “This new, comprehensive accreditation program affirms laboratory operations are meeting existing standards and best practices, adhering to the ISO/IEC 17025 criteria, and are compliant with state and local regulations,” says Nevedal. “This program is the first of its kind developed specifically for the cannabis industry, giving confidence to patients as well as regulators that their test results on these products are accurate and consistent.”
“The program will combine the expertise and resources of the country’s largest accreditation body with the scientific rigor and knowledge base of the nation’s largest medical cannabis advocacy group, benefitting the myriad of laboratories tasked with analyzing cannabis products,” says Nevedal. According to Brauninger, a cannabis-specific accreditation program is vital to the industry’s constantly shifting needs. “The ability to now offer a cannabis testing laboratory accreditation program that is tailored to address the unique concerns and issues of the industry will help to add the necessary confidence and trust in the reliability and safety of the cannabis products on the market,” says Brauninger. “Those laboratories that gain accreditation under this program will be demonstrating that they adhere to the most comprehensive and relevant set of criteria by their compliance to both the underlying framework of the internationally recognized ISO/IEC 17025:2005 quality management system standard and the specific guidelines issued by the AHPA Cannabis Committee.” This type of collaboration could represent a milestone in progress toward achieving a higher level of consumer safety in the cannabis industry.
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The Collaborative Laboratories for Environmental Analysis and Remediation (CLEAR) at the University of Texas at Arlington (UT-Arlington) and the University of Texas at El Paso (UT-El Paso) has begun collaborating with Curtis Mathes Grow Lights (CMGL), a subsidiary of the Curtis Mathes Corporation, and the hemp genetics company ZED Therapeutics. The research will involve characterizing the phytochemical effects of phytochrome manipulation using various LED horticultural lights of differing light spectrum, and novel high-yielding varietals of hemp. All of the hemp plants will be grown by renowned geneticists Adam Jacques, Christian West, and Oriah Love of ZED Therapeutics under the CMGL Harvester LED lights at their Oregon facility. Drs. Kevin Schug and Zacariah Hildenbrand will oversee the analysis of the corresponding samples for the expression of terpenes, flavonoids, and other classes of therapeutic compounds. The expression of 15 primary cannabinoid species will be performed concurrently by Matthew Spurlock of ZED Therapeutics.
“Since its inception, CLEAR has focused almost exclusively on improving environmental stewardship in the energy sector. It is nice to now diversify into the horticultural industry to better understand how chemically-diverse plants like hemp respond to different environmental-friendly LED lights,” says Professor Kevin Schug, Shimadzu Distinguished Professor of Analytical Chemistry and co-founder and the Director of CLEAR.
Hemp has recently garnered significant attention in the mainstream media as a result of the medicinal benefits of its primary natural constituent, CBD. The collaboration amongst UT-Arlington, UT-El Paso, CMGL and ZED Therapeutics is designed to better understand how the variable of light can influence the expression of other medicinal elements.
This research also has the potential to discover novel molecules that may be present in the ZED Therapeutic hemp varietals using high-resolution exploratory instruments that are unique to the laboratories of CLEAR, such as Liquid Chromatography Quadrupole Time-of-Flight Mass Spectrometry (LC-QTOF-MS).
Each lab has access to raw, anonymized data including a consensus mean, z-scores and kernel density plots. This round measured how well 35 cannabis labs perform in testing for potency, pesticides, residual solvents and microbial contaminants such as E. coli, Salmonella, Coliform, yeast and mold.
