Last week, Steep Hill announced they are expanding into Oregon with a laboratory in Portland. According to the press release, the company has licensed its testing technology to Dr. Carl Balog, a renowned pain and addiction physician.
Steep Hill has expanded significantly over the past year, including new laboratories in Pennsylvania, Maryland, Washington D.C. and Hawaii, among other states. The Berkeley-based company works in lab testing, research and development, licensing, genetics and remote testing. In 2008, Steep Hill opened the first-ever commercial cannabis-testing laboratory in the country.
Jmîchaeĺe Keller, president and chief executive officer of Steep Hill, says this is a development that will help them better understand cannabis chemistry and its medical applications. “We are pleased to announce our expansion into Oregon and especially pleased to partner with Dr. Balog, a physician who brings years of pain and addiction experience to the Steep Hill body of expertise,” says Keller. “In addition, Dr. Balog plans to use his specialized knowledge to aid Steep Hill’s research and development efforts to broaden our understanding of cannabis chemistry and to explore its wider medical applications. In partnering with Dr. Balog, we hope that Steep Hill will be able to help physicians around the United States to curb the opioid epidemic by offering Steep Hill Verified™ medicinal cannabis as an alternative to a crisis that plagues this country.”
Dr. Balog, now owner and medical director of Steep Hill Oregon, says medical cannabis could be an excellent harm reduction tool, and hints at it being a possible tool in the opioid crisis. “I deal with the consequences of the opioid epidemic on a daily basis as a pain and addiction specialist,” says Dr. Balog. “The growing trend of using cannabis products as an alternative to opioids highlights the need for regulated testing. Because of the variability of marijuana preparations, testing ensures that scientific rigor is applied in a standardized way. I am dedicated to ensuring that patients have access to safe, tested cannabis, free from contaminants and to verified labels that can be trusted for their content.”
They expect Steep Hill Oregon to be open for business in the second quarter of 2018.
The Craft Cannabis Alliance is a values-driven industry association whose mission is to define, promote, and celebrate authentic Oregon craft cannabis. Though it has only recently launched, it already counts many of Oregon’s most important local brands among its members, and looks poised to help lead a craft cannabis movement both within the industry and among consumers.
When recreational cannabis was originally legalized in Oregon,according to the Portland Mercury, there were residency requirements for obtaining a license, but in 2016 those rules were removed. In the wake of that decision, Adam J. Smith, founder and executive director of theCraft Cannabis Alliance, saw the prospect, and, increasingly, the reality of out-of-state businesses with deep pockets buying up local cannabis businesses, expanding out of state brands into the market, or financing new brands here. It was quickly apparent to Smith that the big money threatened to overwhelm the market, push Oregon-owned companies off of shelves and eventually dominate Oregon’s much-anticipated export market. In May, drawing on his experience as an organizer and drug policy reform advocate, as well as several years working in with Oregon craft industries, he launched the Craft Cannabis Alliance.
Smith has a long history of taking aim boldly at seemingly implacable interests. In 1998, Smith launched the Higher Education Act Reform Campaign (HEA Campaign), which successfully won back the right to federal financial aid for students with drug convictions. That campaign led to the founding ofStudents for Sensible Drug Policy, now the world’s largest student-led drug policy reform organization, active in more than 40 states and 26 countries. Since then, he has participated in a number of public policy and civic engagement campaigns and organizations, serving on the founding boards of the League of Young Voters and the Oregon Bus Project. He’s also written for dozens of publications on drug policy.
The Craft Cannabis Alliance is a membership-based industry association of cannabis businesses with like-minded values, who believe that cannabis is, in fact, Oregon’s next great craft industry. And they want to make sure that means something. We sat down with Smith to learn more about his organization and why he wants to fight big cannabis.
CannabisIndustryJournal: How exactly do you define craft cannabis?
Adam Smith: In the beer industry, the Brewers Association defines a craft producer as one who produces fewer than 6 million barrels per year, and is not more than 25% owned by a larger brewer. And that’s fine for beer, but with cannabis just emerging from its own prohibition, there are broader concerns that we believe a craft industry needs to be responsive to. So we’re less concerned with the size of a company’s production than how it’s producing that product, and how it’s contributing to communities and a healthy industry.
Here in Oregon, there’s a core of the cannabis industry that cares deeply about people, place, planet, and plant. As someone who has spent considerable time writing about and organizing around ending the drug war, it is important to me that cannabis’ first foray into the post-prohibitionist world is not only successful, but that it reflects a shared set of values. When I started talking with people in the industry who take their values seriously, I asked a lot of questions. I wanted to go from “we know it when we see it” to something that could be defined and therefore legitimately promoted. Pretty soon, it became clear that there were six major areas of agreement.
Ethical employment practices
Substantial local ownership
Meaningful participation in the movement to end the disastrous drug war.
The first three requirements, clean, sustainable, and ethical employment practices, are pretty obvious core values for craft producers, and we believe for many Oregon consumers as well.
Substantial local ownership, particularly in a place like Oregon, is an essential component of what the Alliance is trying to organize and represent. We grow some of the finest cannabis in the world in Oregon, and while we’re a small market, we know that eventually, probably sooner than most people realize, the federal walls will come down and we’ll be able to export our products to other states and internationally. At that point, Oregon will be home to a multi-billion dollar industry. The question then, is who will own that?
We are already seeing big out of state and international companies and investment groups buying up brands or starting their own brands here. With tens of millions of dollars behind them, they have the marketing and distribution muscle to push locally owned companies, even those producing superior product, off of shelves. And if foreign-owned companies are dominating shelf space here when those federal walls crumble, those are the companies that will own the export market, and who will ultimately own the Oregon Cannabis brand globally. And if that happens, we will never buy it back.
Southern Oregon, in particular, is a region that has seen little economic growth since the waning of the timber industry. The communities there have a huge stake in how this plays out. Will the cannabis industry build wealth, and economies, and institutions here? Or will Oregon become a low-wage factory for out of state and international corporations.
Beyond local ownership, community engagement is another important component of craft cannabis. The industry, which still faces PR challenges, many of them well earned, needs ambassadors who can demonstrate what a healthy cannabis industry looks like, and who will build the relationships and the credibility necessary to gain the loyal support of their neighbors, local media, and public officials.
Finally, participation in the anti-drug war movement, beyond the self interest of simply opening up the next market, is a must. This industry stands atop a mountain of eighty years of ruined lives and destroyed communities. If you are in the industry, and you are not looking for ways to support drug policy reform, you are profiteering, plain and simple. The drug war is teetering on the brink of the dustbin of history, but it is not over yet. The very existence of a legalized industry is the product of decades of work by many, many individuals, most of whom will never earn a dime from the end of prohibition, and never intended to. We view a healthy legal cannabis market as an important platform for social progress on this front, and we are going to use it.
CIJ: Doesn’t capitalism guarantee that the big money will win out? That striving to maintain one’s values in the face of competition that is laser-focused on profits above all else is inefficient and doomed to failure?
Adam: Believe me, when your name is Adam Smith, you spend a lot of time thinking about capitalism. Let’s be clear, our members are committed to profits. We just don’t believe that nihilism is going to be a profitable strategy in Oregon cannabis, nor should it be. Our goal is to monetize our values by offering a win-win proposition to consumers, opinion makers, political leaders, and everyone else who will benefit from a visionary, responsible, and successful Oregon industry feeding into the local economy.
The choice is not between capitalism and something else. It is between an extractive model of capitalism and a value-adding model of capitalism. Between an industry that seeks to bleed value from the earth, and communities, and employees, and consumers, and one that adds value to everything it touches at every level while producing the best cannabis in the world.
In the end, consumers are the key. If we can be the coolest thing happening in Oregon cannabis, if we can bring consumers into this movement, we will succeed. There’s simply no reason for Oregonians to be buying cannabis grown by a Canadian bank account, even if it’s physically produced here. That is SO not cool. And what’s cool in Oregon will be what’s cool and in demand nationally and internationally as we are able to expand the reach of the legal Oregon industry.
We believe that offering the world’s best cannabis, grown responsibly, by Oregonians who are actually committed to the environment, to their communities, and to social justice is a going to be a powerful marketing proposition here. More powerful than having a famous person on your label or weak attempts at greenwashing.
Within the authentic Oregon craft universe will be super high-end products, as well as more value-oriented offerings, and everything in between. We’re going to make it easy for Oregonians to recognize and support the kind of industry that we’d all like to see here.
CIJ: Why do you think this could be successful in Oregon? Is the industry receptive to this idea?
Adam: Not only the industry, but the media, elected officials, and most importantly, we believe, consumers.
Oregon sees itself, not unjustifiably, as the birthplace of the craft movement in America. Our craft beer, artisan wine, and craft distilling industries are world-class by any standard, and are very well supported locally. Include in that list our local food scene and the myriad artisans of all stripes who ply their trades in the region, and it’s pretty obvious that there will be strong support for a values-driven, locally owned cannabis industry.
Craft is about people making something they love, as well as they possibly can, for themselves and their friends, and to share with others who will love it too. It’s not a coincidence that those products tend also to be of the highest quality.
The key, as I’ve mentioned, is for craft cannabis is to build a partnership with consumers. Let them know who we are, and what we are trying to build, which is an authentic, and authentically Oregon craft cannabis movement.
There are quite a lot of people in the Oregon industry who share this vision, including many of the best and most important brands in the state. The are people who got into cannabis for the right reasons, with a craftsperson’s dedication to quality and mindfulness on all fronts. To truly be a craftsperson is not only to make an exceptional product, but also to be cognizant of the historical and social context of your craft, with a respect for what has come before, and a commitment to setting an example for those who will follow.
Those are our people, and they are well represented in the industry here. Our goal is to organize them and help insure a path to their success.
CIJ: Tell us about how you are educating the industry, consumers and political leaders.
Adam: Well, we launched at the end of May, from the stage at the Cultivation Classic, which highlights and honors the best cannabis in Oregon, grown sustainably and regeneratively. That was a great opportunity for us to introduce ourselves to the part of the industry that we’re targeting, and we were very grateful to Jeremy Plumb of Farma, who is also an Alliance member, and who puts on that incredible event, for that stage.
Right now, we are still a manageable group, size-wise, and we are doing a lot of personal networking in the industry, seeking out the right people to join us. It’s been a lot of “who do we like and trust, who is making great product?” As a long-time organizer, I believe in starting out by putting together the strongest possible group of leaders who are also good people and fun to work with. I’d say that that’s going very well, since we have just an incredible group, who I am honored to stand beside. Over the past several weeks, as we have started to be a bit outward facing, we have had more and more folks in the industry reaching out to us, rather than the other way around. So we’re in a great spot to grow.
On the political side, we really launched the project at the very end of the most recent state legislative session, and so we purposely did not engage that process this year. But over the past several months, we have been seeking out and introducing ourselves to key public officials. Their response has been extremely positive. Here we are, a group of companies who are substantially locally owned, and committed to being transparent and accountable to the health of our employees, our communities, and our state. In an industry that is still very chaotic, and not well organized, with plenty of shady players, I think that they see us as a compelling partner going forward.
CIJ: Some of these standards seem pretty difficult to quantify. How do you expect to judge new member businesses?
Adam: Well, in the areas of clean product, sustainable methods, and ethical employment practices, we will adopt standards being developed and promulgated by third-party certification efforts such as Resource Innovation Institute (energy, water, carbon footprint) and the Cannabis Certification Council (“organic” and fair labor standards). There are others as well, some that exist, things like Clean Green, and some that are still in development. We are beginning to meet with these folks to gauge where they are, and to give input on their standard-setting processes. In the end, hopefully within the next year as more third-party standards come online, we will choose which of those standards to adopt or accept.
Community engagement and anti-drug war participation will be things that we undertake as an alliance, as well as providing support for our members to do these things individually behind their brands
As for “substantial local ownership” we are already discussing the parameters of what that means. Certainly, here in Oregon, there is a need for outside capital. We are not going to fund a robust industry, especially one that is prepared to take advantage of the coming interstate and international markets, with all local funding.
That said, there is a huge difference between having an out of state partner who owns a piece of a local business, and having an out of state or international corporate overlord with a 90-100% ownership stake. And the distinction is important for the future of the industry and for Oregon’s economy.
The temptation is to set the bar at 50% in-state ownership. But what if you are a large cannabis brand, selling in four or five or six states, that is 35% or 40% Oregon-owned? That would likely meet the definition of “substantial.” It is a difficult line to draw, in some sense, but not impossible. As we move forward, we will develop guidelines on this, and we will have a membership committee that can look at an individual company and say “yes, you are substantially Oregon-owned” or “not you are not” as well as a process in place to insure fairness in that decision. Right now, every cannabis company in the Alliance is majority Oregon-owned, and I would expect that to continue except in very rare cases.
CIJ: One of your standards for membership requires participation in the movement to end the drug war. Some might see this as a given, but could you shed some light on this?
Adam: As I mentioned earlier, we see reform movement participation as a moral imperative, and since a lot of my background is in drug policy reform, it’s important to me personally. As an alliance, we hope to partner with organizations like Students for Sensible Drug Policy and NORML, and within the industry with groups like the Minority Cannabis Business Association to both advocate for broad drug policy reform, and hopefully to provide opportunities and support for communities that have been most negatively affected by Prohibition. We believe that those of us participating in the legal, regulated cannabis market have both a responsibility and an opportunity to use our voices to point out the difference between the chaos, corruption, and violence of prohibition, and the the sanity, humanity, and opportunity of a post-prohibitionist world.
Steve Stadlmann has an extensive background as an analytical chemist working in laboratories since the early 90’s. He is now a sales specialist at PerkinElmer, an analytical instrument manufacturer that provides instruments for cannabis testing labs, in addition to a host of other industries. With over two decades of experience working in environmental testing labs, food and beverage labs and agricultural testing labs, Stadlmann is extremely familiar with the instruments used in cannabis labs.
In 2014, he started working in the cannabis space with TriQ, Inc., a technology solutions provider for cannabis growers, where he worked in product development on a line of nutrients. In April of 2016, he started working at Juniper Analytics, a cannabis-testing laboratory in Bend, Oregon. As laboratory director there, he created their quality manual, quality assurance plan, SOP’s and all the technical documentation for ORELAP accreditation. He developed new methodologies for cannabis testing industry for residual solvents, terpene profiles and potency analysis. He worked with PerkinElmer on pesticide methodology for the QSight™ Triple Quadrupole LC/MS/MS system and implemented operational procedures and methods for LC-UV, GCMS and LC-MS/MS, including sample prep for cannabis products.
He left Juniper Analytics about two months ago to work with PerkinElmer as a sales specialist. With extensive experience in helping get Juniper’s lab accredited, he is a wealth of knowledge on all things cannabis laboratory accreditation. PerkinElmer will be hosting a free webinar on September 12th that takes a deep dive into all things cannabis lab accreditation. Ahead of the upcoming webinar, Getting Accreditation in the Cannabis Industry, we sit down with Stadlmann to hear his observations on what instruments he recommends for accreditation, and processes and procedures to support that. Take a look at our conversation below to get a glimpse into what this webinar will discuss.
CannabisIndustryJournal: How can cannabis labs prepare for accreditation with selecting instrumentation?
Steve: Finding the appropriate instrumentation for the regulations is crucial. Ensuring the instrumentation not only has the capabilities of analyzing all the required compounds, but also able to achieve appropriate detection limit requirements. In addition, having an instrument manufacturer as a partner, that is willing and able to assist in method development, implementation and continued changes to the testing requirements at the state level (and potentially national level) is key.
Another consideration is robustness of the equipment. The instrumentation must be capable of high throughput for fast turnaround times of results. Unlike the environmental industry, the cannabis industry has consumer products with expiration dates. Clients demand quick turnaround of results to get product to market as quickly as possible and avoid sitting on inventory for any length of time.
To add to the robustness need, sample matrices in the cannabis industry can be quite challenging in relation to analytical instrumentation. Equipment that is able to handle these matrices with minimal downtime for routine service is becoming a requirement to maintain throughput needs of the industry.
CIJ: What are the most crucial procedures and practices for achieving ISO 17025 accreditation?
Steve: Development and documentation of processes and procedures following Good Laboratory Practices and procedures is essential to a successful accreditation process. Great attention must be paid to the quality objectives of the laboratory as well as associated documentation, including tracking of any errors, deviations, updates, complaints, etc.
Data integrity is a key component to any accrediting body and includes implementation and/or development of appropriate methods with support data proving acceptable results. In addition, documentation of all procedures and processes along with tracking of all steps in the process during routine laboratory work should be a priority. The ability to show a complete, documented trail of all procedures done to any sample is important in ensuring the results can be reproduced and ensuring no deviations occurred, in turn potentially causing questionable results.
Last but not least: training. Laboratory staff should be well versed in any procedures they are involved in to ensure high data quality and integrity. If any laboratory staff does not receive appropriate training in any operating procedures, the data quality becomes suspect.
CIJ: What are some of the biggest obstacles or pitfalls cannabis labs face when trying to get accredited?
Steve: Not fully preparing to meet any agency and testing regulations and requirements will cause delays in the accreditation process and potentially more work for the laboratory. From documentation to daily operations, if any aspect becomes a major finding for an auditor, additional data is usually required to prove the error has been fixed satisfactorily.
Taking the time early on to ensure all documentation, processes and procedures are adhering to any regulatory agency requirements is important for a smooth accreditation process. It is easy to overlook small details when building out the operating procedures that might be essential in the process. Again, going back to data quality, the laboratory must ensure all steps are outlined and documented to ensure high quality (reproducible) data and integrity.
A new employee should be able to come in and read a quality manual and standard operating procedure and produce equivalent data to any laboratory analyst doing the same job. With difficult or challenging operating procedures it becomes even more important that training and documentation are adhered to.
PerkinElmer’s free webinar will dive into these points and others in more detail. To learn more and sign up, click here.
Wana Brands launched their products in Oregon’s market in July 2016, about a year ago. Since then, their brand presence has grown considerably and their products are now in 240 of Oregon’s 375 dispensaries, according to a press release issued this morning.
Wana Brands is an infused products company; they make sour gummies, hard candies and caramels. The business originally launched in Colorado back in 2010 and as of 2016, they own 23% of the market share and had the most sales revenue of any edibles company in Colorado, according to BDS Analytics. The next closest competitor owns 12% of the market share.
According to Nancy Whiteman, co-founder and co-owner of Wana Brands, becoming a market leader in Oregon is a result of their product’s consistency and taste. At the end of last year they launched in Nevada and this year they will launch in Arizona and Illinois. In 2018, they expect to make a big East Coast push, expanding into Massachusetts and Maryland as well.
Election Day last year legalized recreational cannabis in a number of states, including Massachusetts, Maine and Nevada. About a week before Election Day, we interviewed Whiteman about those states coming online and her drive to expand. She said she saw a lot of potential in those markets and she was right. Nevada witnessed a massive surge in demand with the opening of recreational sales in the beginning of July and Massachusetts is expected to be another huge market potential.
In that interview, she explained a bit of their growth model: “The model we are pursuing is a licensing agreement where we partner with existing or new license holders in their state,” says Whiteman. “In many ways they are doing the heavy lifting, but we are providing an enormous lift by licensing our intellectual property to them.”
Now that her company has found enormous success in established markets like Oregon, Nevada and Colorado, they want to make a big push in those fledgling markets on the East Coast. “In both markets [Massachusetts and Maryland], we will be working with a partner who will be licensing our products,” says Whitman. “I think the East Coast is a huge opportunity. There are major population centers in New England, New York and Florida and the markets are almost completely undeveloped at this point.” Wana Brands is also currently entering talks with partners in California, Florida and Maine.
On March 18th, the Oregon Liquor Control Commission (OLCC) issued its first recall for recreational cannabis products. The recall, according to the press release, occurred because an unnamed wholesaler sent cannabis products to a retailer before the pesticide test results were entered into the OLCC Cannabis Tracking System (CTS).
The cannabis grown at Emerald Wave Estate, LLC is said to fail a test for pyrethrins exceeding the Oregon Health Authority (OHA) action level (the action level for pyrethrins is 1 ppm). Pyrethrins are a class of insecticides derived from the chrysanthemum flower. Their toxicity varies a lot depending on exactly what organic compound was used, but has an acute toxicity level that is cause for concern. When exposed to high levels of pyrethrins, people have reported symptoms similar to asthma. Generally, pyrethrins have a low chronic toxicity for humans.
The retailer, Buds 4 U LLC, located in Mapleton, OR, issued a voluntary recall for 82.5 grams of the strain Blue Magoo sold between March 8th and 10th. After finding the failed test results in the CTS, the retailer immediately contacted the OLCC. According to The Portland Tribune, OLCC spokesman Mark Pettinger says the retailer was very cooperative in immediately notifying the OLCC. “The retailer was great,” says Pettinger. “They get the gold star.” The Portland Tribune also says the wholesaler who shipped the cannabis prior to test results being entered is Cascade Cannabis Distributing of Eugene. That mistake could be a violation of Oregon’s regulations, leading to a 10-day closure and up to a $1,650 fine.
According to the press release, the rest of the nine pounds in the batch is on hold “pending the outcome of an additional pesticide retest.” The OLCC encourages consumers to check if their products have the license and product numbers detailed in the press release. They advise consumers who did purchase the affected cannabis to dispose of the product or return it to the retailer. The press release also mentions that they have not received any reports of illness related to the tainted cannabis.
Election Day brought a renewed sense of vigor to the market with voters in eight states legalizing forms of cannabis. California, Nevada, Maine and Massachusetts passed recreational cannabis measures, making legalization’s momentum seem exponential.
But November 8th also gave Donald Trump the presidency, and his cabinet appointments, namely Sen. Jeff Sessions as Attorney General, gave many a feeling of uncertainty for the future of federal legalization. Adding insult to injury, the DEA repeatedly stood by their antiquated and ludicrous judgment for cannabis to remain a Schedule 1 narcotic.
A lot of the fervor surrounding public safety could be described as overdramatic or somewhat unwarranted. 2016 was the year of misinformation. Fake news spread like wildfire with people sharing stories like this or this that turned out to be very misleading or just downright false.
States with legal cannabis came under heavy public scrutiny and addressed problems like consumer education, public safety and lab testing. Pesticides became a highly publicized and persistent issue in a number of areas, with some states regulating it heavily and addressing public health concerns. Plenty of new rules were formed surrounding labeling and testing, with Oregon, Colorado and Washington experiencing some regulatory growing pains.
Those growing pains shed light on the need for regulators to craft rules that allow for changes, adding rules where necessary and getting rid of cumbersome rules that might thwart market growth. Rules need to be able to adapt as the industry grows, much like businesses need to adapt to a changing market climate to stay afloat. This is all the more reason why cannabis businesses need to make their voices heard and work with regulators to move things forward.
With so much uncertainty surrounding the future of legal cannabis in America, the word of the year for 2017 should be resiliency. In a social-ecological context, resiliency is “the capacity of a system to absorb or withstand perturbations and other stressors such that the system remains within the same regime, essentially maintaining its structure and functions. It describes the degree to which the system is capable of self-organization, learning and adaptation.”
Self-organization, learning and adaptation are three very important attributes of a resilient system. Without knowing what will happen when Trump’s cabinet takes the reigns of federal agencies, it is important to prepare for the unexpected. Adhering to standards like FOCUS allows cannabis businesses to prepare for unexpected events like recalls or product safety failures.
Those standards could also become the law down the road, as government officials often look to an industry’s voluntary consensus-based standards when deciding how to regulate it. In 2017, a number of state governments will embark on the heavy undertaking of writing the regulatory framework for legal cannabis.
2017 will bring opportunities and challenges to the cannabis industry. The industry’s rapid growth juxtaposed with political, economic and regulatory uncertainties create a climate that requires resilience to be built into the system at all levels. It is critical, now more than ever, that cannabis businesses build strong relationships with industry groups, advocacy groups and regulators to craft the institutional capacity and mutual trust needed to weather the uncertainty ahead.
Last week, the Oregon Health Authority (OHA) published a bulletin, outlining new temporary testing requirements effective immediately until May 30th of next year. The changes to the rules come in the wake of product shortages, higher prices and even some claims of cultivators reverting back to the black market to stay afloat.
According to the bulletin, these temporary regulations are meant to still protect public health and safety, but are “aimed at lowering the testing burden for producers and processors based on concerns and input from the marijuana industry.” The temporary rules, applying to both medical and retail products, are a Band-Aid fix while the OHA works on a permanent solution to the testing backlog.
Here are some key takeaways from the rule changes:
THC and CBD amounts on the label must be the value calculated by a laboratory, plus or minus 5%.
A harvest lot can include more than one strain.
Cannabis harvested within a 48-hour period, using the same growing and curing processes can be included in one harvest lot.
Edibles processors can include up to 1000 units of product in a batch for testing.
The size of a process lot submitted for testing for concentrates, extracts or other non-edible products will be the maximum size for future sampling and testing.
Different batches of the same strain can be combined for testing potency.
Samples can be combined from a number of batches in a harvest lot for pesticide testing if the weight of all the batches doesn’t exceed ten pounds. This also means that if that combined sample fails a pesticide test, all of the batches fail the test and need to be disposed.
Butanol, Propanol and Ethanol are no longer on the solvent list.
The maximum concentration limit for THC and CBD testing can have up to a 5% variance.
Process validation is replaced by one control study.
After OHA has certified a control study, it is valid for a year unless there is an SOP or ingredient change.
During the control study, sample increments are tested separately for homogeneity across batches, but when the control study is certified, sample increments can be combined.
Failing a test
Test reports must clearly show if a test fails or passes.
Producers can request a reanalysis after a failed test no later than a week after receiving failed test results and that reanalysis must happen within 30 days.
The office of Gov. Kate Brown along with the OHA, Oregon Department of Agriculture (ODA) and Oregon Liquor Control Commission (OLCC) issued a letter in late November, serving as a reminder of the regulations regarding pesticide use and testing. It says in bold that it is illegal to use any pesticide not on the ODA’s cannabis and pesticide guide list. The letter states that failed pesticide tests are referred to ODA for investigation, which means producers that fail those tests could face punitive measures such as fines.
The letter also clarifies a major part of the pesticide rules involving the action level, or the measured amount of pesticides in a product that the OHA deems potentially dangerous. “Despite cannabis producers receiving test results below OHA pesticide action levels for cannabis (set in OHA rule), producers may still be in violation of the Oregon Pesticide Control Act if any levels of illegal pesticides are detected.” This is crucial information for producers who might have phased out use of pesticides in the past or might have began operations in a facility where pesticides were used previously. A laboratory detecting even a trace amount in the parts-per-billion range of banned pesticides, like Myclobutanil, would mean the producer is in violation of the Pesticide Control Act and could face thousands of dollars in fines. The approved pesticides on the list are generally intended for food products, exempt from a tolerance and are considered low risk.
As regulators work to accredit more laboratories and flesh out issues with the industry, Oregon’s cannabis market enters a period of marked uncertainty.
On Election Day, voters in California passed Proposition 64, establishing a recreational cannabis market and regulatory environment. While the state won’t issue the first licenses under the new regulatory scheme until 2018, the medical cannabis industry is already well established.
Steep Hill Labs, Inc., based in Berkeley, California, found in October that 84.3% of samples submitted tested positive for pesticide residue, according to a press release. The announcement came before Election Day, but is particularly eye opening given the massive new market created overnight by Prop 64.
Particularly concerning is their detection of Myclobutanil, which was found in more than 65% of samples submitted to the lab. According to the press release, when Myclobutanil is heated (i.e. smoked or vaporized), it is converted to Hydrogen Cyanide, which is extraordinarily toxic to humans and can be fatal in higher doses.
According to Reggie Gaudino, Ph.D., vice president of science, genetics and intellectual property at Steep Hill, their more recent study shows they detected pesticides in roughly 70% of the samples they received and 50% of those contained Myclobutanil. Gaudino says that up to a third of those samples would have failed under Oregon’s regulatory standards.
If a lab test were failed, it would contain pesticides at or higher than the required action level. Oregon’s action level, or the measured amount of pesticides in a product that the OHA deems potentially dangerous, for Myclobutanil is 0.2 parts-per-million (PPM). Steep Hill’s instrumentation has a method detection limit down to the parts-per-trillion (PPT) level, which is a more precise and smaller amount than Oregon’s action level.
“Those in the cannabis community who feel that all cannabis is safe are not correct given this data – smoking a joint of pesticide-contaminated cannabis could potentially expose the body to lethal chemicals,” says Jmichaele Keller, president and chief executive officer of Steep Hill. “As a community, we need to address this issue immediately and not wait until 2018.”
Potentially harmful pesticides, and specifically Myclobutanil, have been detected in Colorado and Washington’s recreational markets on a number of occasions, proving this is a widespread issue. Steep Hill’s release suggests that California regulators take a look at Oregon’s pesticide regulations for guidance when developing the regulatory framework.
What’s even more troubling is that not all laboratories have or had the capability of detecting pesticides at sufficiently low levels and because of this, other labs had significantly lower rates of pesticide detection, suggesting possible inconsistencies in testing methods, instrumentation, sample preparation or other variations. During a 30-day period in late September and early October, Steep Hill found, using publicly available data, or data from contracted testing, that other labs were only reporting between 3% and 21% pesticide detection.
It is important to note that those samples were not identical and there could be a great degree in variation on the quality of samples sent to different laboratories, so it is not an entirely accurate comparison. Steep Hill does however detect pesticides down to the parts-per-trillion level, whereas many common methods for detecting pesticides look at the parts-per-billion level.
Reggie Gaudino says the Association of Commercial Cannabis Laboratories (ACCL) is using this data to work with Steep Hill and a number of other labs to address these issues. “As a member of the ACCL, and after discussion with ACCL, we have agreed that all future discussion of this issue should not include laboratory names, as this is about educating the industry in general, and making sure all members of the ACCL are developing the best possible methods for detecting pesticides,” says Gaudino. “The ACCL has responded to this data, by inquiring on a larger, industry-wide basis, which represents a better picture of the issue, rather than only in California’s still-technically unregulated market.” The important message is this is a major issue that needs addressing urgently. “As such, the troubling issue remains, across the larger ACCL membership, there is still detection of pesticides in at least 50% of the cannabis being tested.”
According to Jeffrey Raber, Ph.D., president of the ACCL, the industry is experiencing a pesticide problem, but it is very difficult to quantify. “It is fair to say that around 50% of the cannabis being tested contains pesticides, but we really don’t know that exact number until a much more comprehensive statistical analysis is performed,” says Raber. “We agree this is a big problem and that it needs to be addressed, but we are not sure just how big of a problem it really is.” With so much variation in labs in a state where not everyone is required to test products, it is very difficult to pin down how consistent lab results are and how contaminated the cannabis really is. “If all of the labs had the same methodology, samples and shared statistical analyses for a real study then we can look at it closely but it seems we are a ways off from that. I can say confidently however that this is a pretty significant problem that needs addressing.”
Still, Steep Hill detecting pesticides in a majority of their samples and some labs finding as little as 3% should raise some eyebrows. “Unfortunately, our recent study discovered that 84.3% of the samples assessed by our triple quadrupole mass spectrometer contained pesticides,” says Keller. “As of today, this tainted product could be sold in most dispensaries throughout the state of California without any way of informing the patients about the risks of pesticide exposure.”
These findings could mean potentially enormous health risks for medical and recreational cannabis consumers alike, unless regulators, labs and growers take quick action to address the problem.
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. 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.
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.
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).
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.
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.