OGanalytical instruments.

New Cannabis Lab Rules In Oregon Aim to Curb Fraud

By Aaron G. Biros
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OGanalytical instruments.

The Oregon Health Authority (OHA) recently implemented a set of temporary rules effective through June 28th of this year with the goal to establish a set of regulations for cannabis testing by October 1st. An investigation by The Oregonian highlighted some of the previous problems with cannabis testing in the state.

The most impactful rule changes include The NELAC Institute (TNI) mandatory standards for laboratories that the Oregon Environmental Laboratory Accreditation Program (ORELAP) will use to accredit labs. Initial rules in the Oregon medical cannabis program, HB 3460 from 2013, did not specify accreditation rules for cannabis testing.

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The OG Analytical laboratory in Eugene, Oregon is working to comply with new regulations, including new sample collection rules

ORELAP currently performs accreditation for lab testing under the Clean Air Act, Clean Water Act, Resource Conservation and Recovery Act and the Safe Drinking Water Act. The new cannabis testing rules will give ORELAP the authority to accredit and regulate cannabis labs in the state of Oregon.

Rodger Voelker, Ph.D., laboratory director of OG Analytical in Eugene, OR, believes these rules are monumental in establishing legitimacy in cannabis testing. “These new rules have major repercussions mainly because they require not only getting accreditation, but maintaining it with very strict requirements,” says Voelker. “That also includes procedural guidelines that very carefully outline the quality of laboratory practices and establishes a set of criteria for method validation.”

Roger Voelker
Rodger Voelker, lab director at OG Analytical laboratory

Voelker notes that two of the biggest changes are in quality control and data management. “The documentation they require is very thorough and strict with the idea that any aspect of an analysis can be replicated,” adds Voelker. “This is a real win for us in my opinion because now we have an agency that can issue the appropriate credentials as well as have the authority to make punitive measures.”

The timeline for implementation with temporary rules allows state regulators to work with laboratories to perform accreditation and bring laboratories up to speed. According to Shannon Swantek, ORELAP compliance specialist, products that dispensaries sell in medical and recreational markets are required to be tested under the new rules and in the analyte lists by an ORELAP accredited laboratory, starting on October 1st.

Swantek’s job is to accredit cannabis labs to the TNI standards, which is essentially very similar to ISO 17025, just with more prescriptive measures and the ability to pair with state agencies to enforce rules after accreditation. “The timeline for accreditation is dependent on how ready the lab is and how compliant they are to the TNI standard already,” says Swantek. “The culture had gotten so fraudulent that the legislature felt Oregon needed some serious, more strict rules in place.”

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Labs need very expensive instruments to perform all of the testing required by OHA

One of the biggest changes coming to Oregon cannabis testing is the new sampling requirement. “An accredited laboratory employee must take the sample because sampling is where a lack of training or outright fraud is skewing results, which occurs when a grower brings in a sample not representative of the batch,” adds Swantek. Sample preparation methods will also be required to be more robust to meet the action limits of pesticide testing in particular, helping to identify lower levels like parts-per-billion, according to Swantek.

Reports were also lacking key information in the past. The new rules will require more information such as the procedure used, the analyst carrying it out, dilution factors and any other information you need to theoretically reproduce the result. This will result in more accurate labels on products.

Many are concerned that the new lab testing requirements will raise the price of testing too much. In reality, those current prices are not realistic for accurate data, which points to the rampant fraud that ORELAP is trying to eradicate. “The old rules were written in such an ambiguous way that the prices were set by laboratories without a proper quality program or even without proper instrumentation,” says Swantek.

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OG Analytical had to close its doors briefly to meet accreditation

The accreditation process will require particularly robust quality control systems in labs. “Accreditation to the TNI Standard means that lab quality systems will require a documentation system, training procedures, record keeping, personnel requirements, organization details, proof of no conflicts of interest and corrective actions if noncompliant,” adds Swantek. “We single out each method or procedure, look at their raw data and proficiency testing and determine if they are meeting the technical requirements.”

According to Voelker, other industries have learned to adjust their costs with stringent lab testing rules. “I get that no one wants to pay more for lab testing, but the reality is that joining the world of commodities comes with additional costs to ensure consumer safety,” says Voelker. These rule changes will undoubtedly bring more consistency to Oregon’s cannabis industry with accurate lab testing and help the OHA shed more light on issues surrounding consumer safety.

A2LA Accredits First Cannabis Laboratory to ISO/IEC 17025

By Aaron G. Biros
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Frederick, MD– The American Association for Laboratory Accreditation (A2LA) completed its first cannabis testing accreditation for Legend Technical Services, Inc., based in St. Paul, Minnesota. A2LA assessed the laboratory to ISO/IEC 17025 which include the general requirements for the competence of testing and calibration laboratories. The laboratory is now able to test medical cannabis in compliance with Minnesota’s Medical Cannabis Registry Program.

The American Assocation for Laboratory Accreditation (A2LA)
The American Assocation for Laboratory Accreditation (A2LA)

Their scope of accreditation (certificate 2950.01) will include testing for cannabinoid potency and profile, terpenes, pesticides, residual solvents, Mycotoxins, heavy metals and analyzing aerobic bacteria, yeast and mold, E. coli, Salmonella and gram-negative bacteria in medical cannabis products.

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Roger Brauninger, biosafety program manager at A2LA

According to Roger Brauninger, biosafety program manager at A2LA, this bodes well for cannabis laboratory standards in the future. “We are pleased to provide accreditation to cannabis testing laboratories and recognize the potential international standards have to help ensure safety of all legal products entering the marketplace,” says Brauninger. “Legend Technical Services, Inc.’s accreditation with A2LA recognizes their commitment to providing the highest quality laboratory services and confidence in the safety of cannabis products that they test.”

A2LA’s cannabis accreditation program aims to establish a set of standards for quality in testing for cannabis edibles, concentrates and flower. Many states where cannabis is legal require ISO/IEC 17025 for cannabis laboratories as a baseline standard.

Researching Cannabis Genetics: A Q&A with CJ Schwartz, Ph.D.

By Aaron G. Biros
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Studying cannabis genetics is a convoluted issue. Strain classification, medicinal effects and plant breeding are particular areas in the science of cannabis that still require heavy research. Marigene, a company researching cannabis genetics, is currently working with universities and research institutes to help map the cannabis genome and catalog genetic variation.

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CJ Schwartz, Ph.D.

According to CJ Schwartz, Ph.D., chief executive officer and founder of Marigene, their mission is to “to classify, certify, and improve cannabis.” After studying genetics and cellular biology at the University of Minnesota, Schwartz received his Ph.D. in biochemistry from the University of Wisconsin. His research in the past decade has focused on genetic variations that control flowering time, discovering the expression of a gene called Flowering Locus T leads to differential flowering time of plants and is dependent on their native locations. We sat down with Schwartz to learn more about his research and collaborative efforts.


Cannabis Industry Journal: Why are you researching mapping the cannabis genome?

CJ Schwartz, Ph.D: We seek to identify the genetic differences among cannabis strains and the genes responsible for these differences. Genetic differences are what cause different strains to have different effects. DNA allows reproducibility, consistency, and transparency for your cannabis strains.

The more information we gather about cannabis genetics, the more tools we have available to create tailored strains. Cannabis is a targeted compound. It interacts with a very specific system in the human body, similar to hormones, such as insulin. Understanding the cannabis genome will help bring legitimacy and integrity to cannabis products, and allow us to better understand how chemicals from cannabis interact with the human brain. Genetic identification can provide a method of certification to more comprehensively describe plant material.

Schwartz doing sample preparation on the lab bench.
Schwartz doing sample preparation on the lab bench.

CIJ: How did you get involved in cannabis research?

Schwartz: My interest in cannabis guided my research career. Cannabis may not be a cure-all, but it has significant and measurable medicinal effects for many patients.

To allow true development of cannabis products, we need more science! Our genetic analysis is required for normalization and acceptance of cannabis products, but also essential for future breeding efforts to develop better and more useful plants.

Our sister company, Hempgene, is applying all of the same technology and techniques for hemp research. One focus of Hempgene is to manipulate flowering time in select hemp cultivars so that they mature at the appropriate time in different environments.

CIJ: What do you hope to accomplish with your research?

Schwartz: We can develop or stabilize a plant that produces a very specific chemical profile for a specific condition, such as seizures, nausea or pain. By breeding plants tailored to a patient’s specific ailment, a patient can receive exactly the medicine that they need and minimize negative side effects.

The current term describing the interaction of cannabis compounds is called the entourage effect. Interactions among compounds can be additive or synergistic. The entourage effect describes synergistic effects, where small amounts of compound A (e.g. Myrcene) vastly increase the effects of compound B (e.g. THC). Instead of flooding one’s body with an excessive amount of chemicals to get a non-specific effect, cannabis plants can be bred to produce a very specific effect.

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A view of some of the work stations inside the laboratory at Marigene.

Currently our goal is to catalog the natural genetic variation of cannabis, and to identify DNA changes that affect a trait of interest. Once superior variants of a gene are identified, those variants can be combined, by marker-assisted breeding, to produce new combinations of genes. How different cannabis chemicals interact to produce a desired effect, and how different human genetics influence the efficacy of those chemicals should be the ultimate goal of medical marijuana research.

We are working closely with academic institutions and chemical testing labs to gather data for establishing correlations between specific cannabis strains and desirable chemical profiles. Our closest collaborator, Dr. Nolan Kane at UC-Boulder, is working to complete the Cannabis genomic sequence and generate the first high- resolution cannabis genetic map.

We are currently accepting samples and we produce a report in roughly two to three months. For one sequencing run, we identify 125 million pieces of DNA that are 100 base pairs long. We get so much information so there is a considerable time commitment.

MedicineManTechGrow

Legal Cannabis Industry’s Energy Bill Not So Alarming

By Aaron G. Biros
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MedicineManTechGrow

New Frontier, a financial data analysis firm, recently released a report that caused a media frenzy over the cannabis industry’s alarmingly high energy bill. The Washington Post published an article with the headline “The Surprisingly Huge Energy Footprint of the Booming Marijuana Industry.” Denver news publication, Westword, posted an article with the headline “Legal Marijuana Used Over $6 Billion in Energy Last Year, Report Says.” There are dozens of articles published suggesting the legal cannabis industry’s energy consumption has a $6 billion price tag, which is misleading.

What’s the problem? The $6 billion figure that New Frontier cites comes from a 2012 research study that estimates the energy footprint for legal and illicit markets. That means the $6 billion estimate includes the legal cannabis industry and the black market’s energy footprint. To put it in perspective, the size of the entire legal cannabis industry in the United States was less than that in 2014 at $4.6 billion, according to the ArcView Group.

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The projected energy demand for growing in the Northwest through 2035, from the New Frontier report.

According to Giadha Aguirre DeCarcer, founder and chief executive officer of New Frontier, only including the legal market would significantly reduce the size of this estimate. “Dr. Mills’ study looked to assess the total energy use associated with marijuana in the US, not just that of the nascent legal marijuana industry; including this holistic view is an important growth determinant for the legal market as the U.S. transitions from a predominantly illicit production environment,” says Decarcer.

Dr. Evan Mills, energy analyst at the Department of Energy and member of the UN Intergovernmental Panel on Climate Change, conducted the 2012 research study and is a senior advisor on the New Frontier report.

Brett Roper, founder and chief operating officer at Medicine Man Technologies, believes those numbers still need to be adjusted. “Dr. Mills’ study is based on pre-2011 data and sources that date back as far as 2003,” says Roper. “The study provides figures that are, quite frankly, outdated based upon changes in the industry related to cultivation and production efficiency.” The study focuses on cultivation increments of sixteen square feet consuming 13,000 KW per year that, according to Roper, is not reflective of current indoor cultivation technology and energy consumption metrics.

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A back-end view of Medicine Man Technologies’ indoor production facility

According to Roper, today’s efficiencies, scalable cultivation operations and new technology could explain the overestimate from five years ago. “We are a Tier III operator that produced approximately 5,100 (+/-) pounds of dried cured flower in 2015 and have a total power bill of approximately $420,000 for the year,” he says. Note that the company had roughly $18 million in revenue in 2015. “Using this metric we have a total energy billing of approximately $83 per pound grown.” According to Roper, they cultivate completely indoors with HPS lights that are not particularly energy-efficient, so this estimate is relatively conservative.

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Medicine Man Technologies’ approximately 40,000 sq. ft. cultivation facility.

Dr. Mills’ research cites much higher numbers for the cost of energy per pound of finished product than Roper’s findings. “From the perspective of a producer, the national-average annual energy costs are approximately $5500 per module or $2500 per kilogram [roughly 2.2 pounds] of finished product,” says Dr. Mills. That would suggest the average cost of energy for indoor growing to be above $1,000 per pound, roughly half the current average wholesale price. These numbers would mean that cannabis growers, on average, lose roughly 50% of their total revenue to their energy bill. Medicine Man Technologies’ energy usage is less than 3% of their total revenue.

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Xcel, a Colorado utility, showing the rise in electricity demand for cultivation.

The New Frontier report does provide caveats on the use of Dr. Mills’ research. “While this analysis was conducted before many of the recent advancements in cultivation technologies, it highlights the significant energy-related environmental impact of marijuana production, and makes the issue of energy efficiency not just one of competitive advantage but also one of environmental sustainability.”

New Frontier’s CEO, DeCarcer, stresses that their report is intended to serve as a starting point to a much broader exploration of energy use in cannabis. “We are already in the process of establishing a partnership through which New Frontier will ingest real time energy-use data from cultivators across different legal markets for analysis in our next report,” says DeCarcer. “Our goal is to build on the work done by Dr. Mills and others in order to ensure that we are providing the most accurate representation of where the industry currently is, and where it is headed.”

Regardless of the discrepancies, this kind of discourse is great for prompting innovation and getting people to think about the environment. It is very important to examine the energy footprint of cannabis cultivation as it raises questions regarding energy efficiency, which would help the industry’s long-term environmental sustainability.

Ask the Expert: Straight Talk on Safety, Defense and Security, Part II

By Aaron G. Biros, Bruce E. Lesniak, Lezli Engelking
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In this week’s Straight Talk on Safety, Defense and Security, we answer a reader’s question about traceability in quality processes and offer some practical advice for building a safety and security strategy. Travis Lodolinsky from Gleason Technology submitted this week’s question. For a response, we sit down with Lezli Engelking, founder of the Foundation of Cannabis Unified Standards (FOCUS), to help answer your questions. If you have questions about safety, defense and security in cannabis, please ask them in the comments section below and we will address them in the next edition of Straight Talk on Safety, Defense and Security.

T. Lodolinsky: How are safety processes being tracked in the industry to ensure regulations and quality assurance are being uniformly enforced throughout?

Lezli Engelking: In related industries, such as herbal products or pharmaceuticals, the FDA has created guidelines, or current good manufacturing processes (CGMP) that control for the quality, consistency and safety of the products being produced. Businesses must be certified by independent third parties to demonstrate they are following CGMP to protect public health and consumer safety. CGMP is a proactive approach to quality assurance. A basic tenant of CGMP is that quality cannot be tested into a product after it is made; quality must be built into the product during all stages of the manufacturing process. One common misconception is that CGMP only covers the process of manufacturing itself. CGMP actually covers all aspects of the production process including materials, premises, equipment, storage, staff training and hygiene, how complaints are handled and record keeping.

Because cannabis is federally illegal in the US, the FDA has not developed cannabis-specific CGMP guidelines, so lawmakers do not have the benefit of having those guidelines available to base regulations on. So to answer your question, state cannabis regulations do not track processes and procedures used by cannabis businesses to control for safety or quality because they do not have the federal guidelines. Instead, most state cannabis regulations currently take a reactive approach to safety, mandating only for testing of the final product. While testing is an extremely important and valuable part of any quality management program, just analytics is not enough.

This is precisely why FOCUS was created and how they assist business owners and regulators, while fulfilling the mission of protecting public health, consumer safety and safeguarding the environment. The FOCUS standards are a cannabis-specific system of guidelines (cannabis-specific current good manufacturing practices) to ensure products are consistently produced according to quality standards. FOCUS provides detailed guidance and independent, third party auditing services for all key aspects of the cannabis industry including cultivation, extraction, infusion, retail, laboratory, security, packaging, labeling and sustainability.

CannabisIndustryJournal: What advice can you offer to cannabis businesses for product safety, defense and security prior to standardization?

Bruce E. Lesniak: Businesses that make products infused with cannabis (I call these businesses “plus one” companies because they produce products that include one more ingredient than traditional food products), require a carefully written master plan that specifically addresses the unique qualities, sensitivities and critical areas of the business. When building a comprehensive plan I address three questions:

  • Why (identify the why, this is your preventative, overarching strategy)?
  • How (addresses the “why question” with products, services and training)?
  • What (what is your reactive strategy that addresses actions and activities to be performed in the event of a breech)?

First and foremost, consumer-facing businesses must safeguard their products to the public. One product recall or illness related incident could spell disaster. Build your plan correctly the first time. Contact an industry expert to review your facility and help build and implement your plan. This will save you money by quickly exposing vulnerabilities and providing corrective measures specific to your business needs and requirements. Even though product safety and defense are closely related to security and should share a complementary strategy, product safety and defense are unique (due to standards and regulations), and should be treated as such.

Banks not accepting industry money complicates normal business operations and security planning, causing retail operations to handle and store large sums of cash. I asked industry expert and security professional, Tony Gallo of Sapphire Protection LLC, what is the single most important piece of security equipment you are currently providing for the retail and dispensary owner? “Design an air tight policy of handling money,” says Gallo. “Remove money often from cash registers and place it into the best safe for your application!”

Spend time familiarizing yourself with all things product safety and defense (there are volumes written on food safety and food defense, thus the “plus one” reference). This a great starting point and protecting the consumer protects your business. When it comes to designing your security application, consult an expert! Take into account that the cannabis industry is unique due to its “plus one” ingredient. Therefore you need to build your security systems, applications and policies to systematically protect your employees, facility, suppliers, transportation, manufacturing, distribution, warehousing, supply chain and brand.

adamplants

Adam Jacques: Award-Winning Grower, Pioneer and Medical Cannabis Provider

By Aaron G. Biros
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adamplants

Walking into one of the grow rooms on Adam Jacques’ farm outside of Eugene, Oregon, you will find dozens of cannabis plants and a whiteboard on the wall with the note “Do it for Frank” across the top. This is a reminder of why Jacques and his team are growing medical marijuana: To help people.

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Above some notes is their daily inspiration: “Do it for Frank”

Frank Leeds, one of Jacques’ cannabis patients, lost his battle with cancer in early January.

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A view of the grow room where they have 48 plants in flowering..

Jacques was working with Frank for the past five years to develop “Frank’s Gift,” a high-cannabidiol (CBD) strain with a slew of potential medical benefits. Deeply saddened by the loss of his patient and close friend, Jacques continues to run his grow operation, Grower’s Guild Gardens, where he and his wife, Debra, work to get high-quality, safe medicine to their patients.

His patients and other publications have repeatedly referred to Jacques as a “legend.” Jacques previously won Canna Magazine’s award for Most Influential Grower in the Northwest.

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Adam Jacques looking over his plants in their vegetative stage.

On their farm, strain testing is currently underway for the upcoming changes in the recreational program in Oregon. “With the way the medical laws are now, I have 48 plants for my patients, including multiple high-CBD genetics, and any excess flower will be sold to recreational dispensaries to cover our overhead costs,” says Jacques. When the Oregon Liquor Control Commission (OLCC) grants them their recreational grow license, he will take some of those trial strains to an outdoor crop estimated to be in the thousands of plants on his 42-acre farm.

Presenting at the Dispensary Next Conference a few weeks ago, Jacques said to a crowded room of industry professionals: “The biggest reward is helping people.” Jacques and his team’s work exemplifies the good that smaller grow operations can do for the industry.

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This plant is roughly four weeks from harvest, currently in the flowering stage.

Jacques’ recent work has taken him to help Leni Young, a four-year-old girl originally from Alabama who suffers from debilitating seizures. Her parents became medical refugees when she was not selected for an Alabama study involving cannabis oil. As a result, the Young’s took their daughter to Eugene, where with the help of Jacques and his team, they could get her customized cannabis oil with high doses of CBD and tetrahydrocannabinolic acid (THC-A) that could help treat her seizures.

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Left to right: Wayne Young with his daughter, Leni Young, and son, Thomas Young, alongside Debra Jacques.

The cannabis oil that Jacques created has brought Young’s seizures down from multiple occurring every day to just one every six weeks. “One-strain solutions like ‘Charlotte’s Web’ are no longer the answer for treating medical conditions,” says Jacques. “We create something custom designed for individual patients, and it is working.” CBD and THC-A, the main active ingredients in Leni’s medicine, are two of the non-psychoactive compounds in cannabis believed to have extraordinary medical benefits.

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Jacques inspecting some of the different strains they are testing for the recreational program.

Less than three weeks ago, a bill was introduced to the Alabama legislature that would decriminalize the possession of and allow patients to get high-CBD oil. The bill is called “Leni’s Law.”

Jacques’ goal in the long term is to get clinical trials with peer-reviewed studies to connect the dots between his patients, cannabis and evidence-based medicine. “I am working with a laboratory in Arizona and a doctor from Israel to perform a peer-reviewed study,” he adds. “Getting peer-reviewed will allow me to provide legitimate scientific evidence for my claims and get the knowledge into the hands of my patients.”

Looking into the immediate future, Jacques is wary of different regulations coming to Oregon. “Once you go recreational with your business, you lose the ability to provide any sort of a medical recommendation,” says Jacques. “I do not want to see the recreational program and the desire for profits push out our ability to help patients.”

Jacques and his team represent the idea that embodies the cannabis legalization movement, which is to help people get the medicine they need. “The money is not really important any more,” says Jacques.

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Dispensary Best Practices: A Q&A with Stephen Spinosa

By Aaron G. Biros
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goodchem.exter

Stephen Spinosa, vice president of retail operations at Good Chemistry, has over seven years of experience working in the cannabis industry in the operation and management of licensed dispensaries.

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Stephen Spinosa, VP of retail operations at Good Chemistry, delivering the keynote at Dispensary Next

He was previously an inventory manager in a 7,000-square-foot medical marijuana cultivation in Colorado. Spinosa is currently part of the team at Good Chemistry dispensaries, which has locations in Aurora and Denver, Colorado. He oversees staff training, state and local regulatory compliance and seed-to-sale inventory tracking.

Spinosa recently delivered a keynote presentation at the Dispensary Next Conference in Portland, Oregon titled “From Waiting Room to High-End Retail Experience: How Dispensary Culture Has Changed from 2009 to Now.” He discussed the rise of high-end experience and gave tools for dispensaries to improve retail operations.

In the presentation, he covered supplier quality, security, tiered pricing, inventory tracking and safety issues. Much of what he discussed revolved around the consumer experience and how important the culture at a dispensary is for the buying experience. After his keynote presentation, I sat down with Spinosa to discuss the customer experience, consumer education and safety and sales trends.

Cannabis Industry Journal: What are some of the key areas where dispensaries can improve the quality of customer experience?

Stephen Spinosa: Ultimately, the dispensary experience is like any retail experience. Good Chemistry’s staff is always friendly, smiling, welcoming and helpful to all customers that walk through our doors. Having employees who are experts at providing advice to any user level, and who are extremely knowledgeable on each strain and edible effect is extremely important to us. It is all about making the customer feel comfortable in their experience, especially for novice users who may feel timid when entering a dispensary for the first time.

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Smiling employees greet customers in a clean environment

Good Chemistry’s high-end retail experience includes our up-to-date LED menu screens that present our daily flower menu. That may seem like common sense, however, you would be surprised how many dispensaries do not have a flower menu for their customers to peruse.  It helps the customer navigate through all the strains that we offer, and adds to the overall retail experience. We offer twenty or more strains every day.

Additionally we do not have an armed guard hovering at the entrance, making our guests feel uncomfortable. We have highly sophisticated security, like every dispensary, but we’ve left out this intimidating and unnecessary aspect.

CIJ: Can you discuss what you and your employees do for consumer education and safety?

Spinosa: When introducing cannabis to consumers, it is our mission to educate our customers on the correct dosage based on experience level. Our bud tenders are trained to ask a lot of questions before recommending anything. If a customer is a first timer, the bud tenders will have certain recommendations based on their experience level, such as high-CBD [cannabidiol] flower, a low THC percentage vaporizer pen, or a 1-5mg edible serving.

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The exterior of a Good Chemistry dispensary

That said, strains of cannabis often cannot be neatly compartmentalized into sativa vs. indica, so our bud tenders also educate customers about the entourage effect, the interaction of the various compounds in marijuana to produce each strain’s unique feeling.

We have developed a pioneering category system to help our customers, whether novice or connoisseur. The system is broken down into four main categories to help consumers decide what sensation they would like to experience: stimulation, relaxation, sleep or relief. We use the four categories to guide our customers through our daily flower menu by labeling each strain with a category.

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This wall display shows customers the Good Chemistry categories of strains

If a customer is purchasing edibles, we provide an Edibles Education brochure from the Cannabis Business Alliance that stresses the Start Low, Go Slow motto. We also educate consumers on the difference between edibles made with butter vs. oil. Additionally, all of our third party vendor edible products for adult-use are packaged safely in 100% child resistant packaging.

It is important that our customers have a great experience, which is always possible with good guidance. A happy customer is a repeat customer. We are also well aware of the importance of educated employees. Our employees go through a formal training program, and we have monthly meetings where vendors come in and educate the employees on how to sell and dose various products.

CIJ: Can you tell me about your inventory and some consumer trends you are noticing?

Spinosa: Flower is the biggest seller, and for good reason: we have award-winning strains that are $30 an eighth, every strain, every day. Not many dispensaries offer such incredible pricing. Right now, the purchasing trend tends to lean toward the strains that have the highest THC percentage.

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The interior of the dispensary has digital displays and ample lighting.

This may not accurately depict the best strains, because there have been findings that the entourage effect means different strains can have unique lifts, but it is definitely what the industry is seeing as far as sales trends. As far as edibles, gummies are the biggest sellers followed by hard candies, chocolate and baked goods. Lastly, concentrates such as live resin, shatter and wax have increased in popularity. Good Chemistry produces a new product called solvent-less rosin, concentrated THC oil that is produced using just heat and pressure. Rosin is currently picking up a good amount of traction, although not many dispensaries currently offer it.

amandarigdon

Amanda Rigdon to Offer Guidance on Method Validation at Cannabis Labs Conference

By Aaron G. Biros
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amandarigdon

With multiple states now requiring third-party certification as part of licensing cannabis laboratories, there is a large role for laboratory accreditation in the cannabis industry. Using method validation can prove that your data is reproducible and that you have robust methods for sample preparation and calibration. All of these tools are instrumental in getting a laboratory accredited.

Amanda Rigdon, associate marketing manager for GC columns at Restek, Inc.
Amanda Rigdon, associate marketing manager for GC columns at Restek

Amanda Rigdon, associate marketing manager for gas chromatography columns at Restek, Inc., will deliver a presentation, Opportunities and Challenges for Method Validation in the Evolving Cannabis Industry, at the first annual Cannabis Labs Conference taking place this March 9th in Atlanta, Georgia. The Cannabis Labs Conference will be co-located with the third annual Food Labs Conference and the Pittsburgh Conference on Analytical Chemistry and Applied Spectroscopy (Pittcon) at the Georgia World Congress Center.

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Scott Radcliffe, technical support scientist at Romer Labs, Inc.

In her presentation, Rigdon will discuss established validation guidelines from a variety of regulatory bodies. “Method validation is absolutely critical to the cannabis industry,” she says. “Accurate test results not only help to protect consumers, but because of the high dollar value of cannabis products, accurate results can also protect producers from false positives, and laboratories in backing up their results.” She will also be sharing actual validation data from a number of cannabis analytical methods.

Scott Radcliffe, technical support scientist at Romer Labs, Inc., will share his validation methods of immunoassays for the detection of pathogens and mycotoxins in cannabis. He will include a discussion of specific rapid pathogen detection methods for Salmonella and E. coli O157 species. This will cover their small-scale validation studies with partner labs in Michigan and Washington for immunoassays.

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Stephen Goldner, Esq, founder of Pinnacle Laboratory and Regulatory Affairs Associates

Stephen Goldner, Esq, founder of Pinnacle Laboratories, will discuss how cannabis labs can apply FDA lab practices with recommendations for short and long term management implementation. Goldner’s presentation will include a discussion of  preparation for FDA involvement in sate regulatory systems.

Beyond validation methods in laboratories, the Cannabis Labs Conference will feature several presentations on ISO/IEC 17025:2005 compliance, the need for standardization, seed-to-sale traceability, FDA best lab practices and cannabis quality. Nic Easley, chief executive officer of Comprehensive Cannabis Consulting (3C), will deliver the keynote presentation on the role of quality assurance in the cannabis industry.

A Q&A With Christian Hageseth: Innovate or Die

By Aaron G. Biros
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Christian Hageseth, founder of American Cannabis Partners, Green Man Cannabis and the Colorado Cannabis Ranch and author of “Big Weed,” gave a presentation at the recent High Times Business Summit titled “Innovate or Die.” During the session, he discussed at length why industry leadership in innovation is key in determining the progress and growth of the cannabis industry.

Christian Hageseth, founder of American Cannabis Partners
Christian Hageseth, founder of American Cannabis Partners

His company, Green Man Cannabis, has won the Cannabis Cup four times and he has been a partner at five dispensaries and six grow operations. He is currently a partner at two dispensaries and two grow operations and he is a founding partner of a medical research group in Israel. Christian Hageseth has years of experience working with cannabis in a number of capacities that has culminated in a keen eye for understanding the cannabis industry. We sat down with Hageseth to learn more about some of his expectations for the industry’s future.


 

Cannabis Industry Journal: Can you discuss why you decided to take your research group to Israel?

Christian Hageseth: Obviously the United States has barriers to medical research on the plant, so it is seriously lacking the ability to discover more about the plant. We know the NIH [National Institutes of Health] has been helping Dr. Raphael Mechoulam in Israel to study cannabis and THC for the past 35 years, even though this is not permitted in the United States. Israel is willing to allow the research in an open format. We will be able to get an independent review board and the ability to work with institutions in Israel.

Christian Hageseth, founder of American Cannabis Partners, Green Man Cannabis and the Colorado Cannabis Ranch and author of "Big Weed"
Christian Hageseth, founder of American Cannabis Partners, Green Man Cannabis and the Colorado Cannabis Ranch and author of “Big Weed”

CIJ: What kind of research are you looking to accomplish?

Christian: We are researching what cannabis formulation and delivery mechanism would work better than what is available for certain ailments. The research should initiate in March with the goal of reaching clinical trials in the future. We are looking to study the treatment of five ailments with cannabis: migraines, joint pain, insomnia, irritable bowel syndrome and psoriasis.

CIJ: How do you think your research will help people?

Christian: I own dispensaries, and I see people come in and ask for advice on how to treat their insomnia or migraines all the time. We want to be able to recommend something that will accurately treat them. Simply recommending an indica or sativa strain is such a hollow answer for people that are actually in physical pain and need precise treatment. We want to be able to provide the real answers to people seeking help.

The Colorado Cannabis Ranch will be the first cultivation center in Colorado to offer educational tours, similar to a brewery or winery
The Colorado Cannabis Ranch will be the first cultivation center in Colorado to offer educational tours, similar to a brewery or winery

CIJ: Switching gears a little, how is progress on the Colorado Cannabis Ranch?

Christian: We are ready to break ground on the Colorado Cannabis Ranch (the Weedery) in the beginning of March this year. We expect greenhouses at the Ranch to be operational by July along with a summer concert series a little later.

CIJ: Looking at the cannabis industry as a whole, where do you think innovation will come from in the near future?

Christian: Emerging medical technologies will have the greatest impact on the industry. Nanoparticle delivery systems for sublingual drug delivery are one example of biotechnology that I foresee having a major impact. I can expect some major innovations in some of the process technology around extraction. The technology around extracting specific and separate cannabinoids in particular will get refined more and more. The industry as a whole and market expansion will be driven by product development.

Pesticide Position Paper: Prepared by Comprehensive Cannabis Consulting (3C)

By Adam Koh, Nic Easley
4 Comments

Those that follow the legal cannabis industry are undoubtedly aware of the struggles of Colorado to regulate pesticide use on cannabis. At the time of this writing, there have been 19 recalls of products contaminated by pesticides in as many weeks. Authorities could not in all cases identify exactly how many units of products may have been tainted, but based on the numbers available, roughly 200,000 individual cannabis products, if not more, have been pulled from dispensary shelves. Along with these recalls have come a large amount of coverage and commentary from various news outlets, industry stakeholders, and even those companies who have had products pulled from shelves.

As this is a controversial and contentious subject, it can be difficult to parse and evaluate the various points of view being offered. In what follows, we will outline the issues at hand objectively: first providing a brief overview of federal and state pesticide regulations and how they pertain to cannabis; addressing claims of whether pesticide usage is “safe” or not; and, finally, offering our opinion of how the cannabis industry should address the pesticide conundrum considering the current regulatory environment and the state of our knowledge.

Before diving in, we are also aware that there is controversy around cannabis testing methodologies, and that the reliability of cannabis testing labs in general has been called into question by a number of the companies that have faced recalls. While we cannot comment on the operations of particular labs, we do support the application of consistent standards, proficiency evaluations, and stringent regulatory oversight to testing labs themselves, so that their results can be assured of being beyond reproach.

Still, 3C’s stance is that quality cannot be tested into a product. To have growers continue to produce contaminated cannabis only to see it recalled repeatedly is unsustainable for the industry; indeed, it threatens its very existence, as we discuss below. That is why we focus in this paper on the cultivation of the plant, as correcting problems on the production side is the only way to ultimately resolve the dilemma in which the industry finds itself.

Pesticide Regulation in the US Relative to Cannabis Cultivation

Cannabis’ pesticide problems stem in large part from the fact the pesticide regulation takes place at the federal level, under the auspices of the EPA. All pesticides undergo years of research and development before they can be sold to farmers and employed on crops. That research addresses questions such as where and how a pesticide can be employed, on what crops, in what concentrations, with what frequency, and how long before harvest can a pesticide be applied. Questions of worker safety are also addressed, such as those concerning what Personal Protective Equipment (PPE) might be required and how long workers must avoid treated areas (Re­Entry Intervals), among other concerns.

The fruits of such studies are then distilled to the contents of a pesticide’s label, which must be registered with and approved by the EPA before a pesticide can be distributed for sale. Federal and state laws require that pesticides be applied according to label directions, making the label a legal document of sorts. “The label is the law,” is a phrase common among agricultural professionals with which the legal cannabis industry is becoming acquainted.

The sticking point in regard to cannabis is that, due to its federal illegality, no research has been performed on the use of pesticides on cannabis. Due to the lack of research, no pesticides registered currently with the EPA are labeled for use on cannabis. Since all pesticides must be applied according to label specifications, this essentially prohibits pesticide use in cannabis production. However, some labels are written in such a broad manner that the use of those pesticides could not be construed as a breach of the legally­ binding use directions. Additionally, certain pesticides are of such low­toxicity that the EPA has deemed that their registration is not required; these are known as minimum­ risk products under section 25(b) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). At this time, the Colorado Department of Agriculture (CDA), in an attempt to offer guidance to cannabis growers, is maintaining a list of such products that, either due to broad label language or 25(b) status, may be used on cannabis without that use being a violation of the label.

Are Pesticides Safe for Use on Cannabis?

Since the first plants to be quarantined after discoveries of improper, off­-label pesticide use to the most recent recalls, some of the Colorado cannabis companies caught up in those enforcement actions have made public statements claiming that their products are safe. These statements are dangerously misleading, as they do not take into account the issues laid out above, nor the facts that follow.

Frequently, attempts to justify such claims point out that pesticides are employed on our food and therefore must be okay to apply to cannabis as well. This is a classic case of comparing apples to oranges; or, in this case, comparing apples and oranges to cannabis. Such data cannot be bridged for the simple reason that apples and oranges (and most other agricultural food crops) are not smoked. Smoking remains the primary method of cannabis ingestion, but cannabis products are also vaporized (concentrates), consumed (edibles), applied to the skin (topical creams and patches), and taken sublingually (tinctures, sublingual strips).

As noted, the studies that pesticides must undergo prior to being approved by the EPA involve measuring acceptable residues based on the method of consumption of the final product. Since most food is consumed and digested, few pesticides on the market have undergone pyrolysis studies, which examine how the chemical structures of pesticides degrade when burned. This means that while the fungicide myclobutanil, the active ingredient in Eagle 20EW, may be approved for use on grapes, that approval is meaningless in regard to cannabis, as grapes are not smoked and the relative safety of myclobutanil residues was not tested in regard to such a consumption method.

While studies may eventually reveal that certain pesticides may be used on cannabis without ill effects to the end users, such research has not been performed and no one can say with certainty what the effects of consuming cannabis containing pesticide residues might be. Even the CDA qualifies the list of products that may be used without violating labeling guidelines with the following statement, “These products have not been tested to determine their health effects if used on marijuana that will be consumed and thus the health risks to consumers is unknown.”

Again, no one can currently say what pesticides, if any, can be safely employed on cannabis; anyone claiming definitively that their products are safe despite off­-label pesticide use is making a statement that at this time lacks any scientific basis whatsoever.

Another claim made numerous times by companies defending their off­-label pesticide use is that no one has yet fallen ill from pesticide use on cannabis. While this is true, we must remember that we are in uncharted territory, and no large­scale public health studies have been done to determine what, if any, effects result from consuming cannabis to which pesticides were applied. We hope that no ill effects will surface, but the fact of the matter is that chronic health issues may take years to show themselves and a public health crisis may yet emerge.

Recommendations for the Cannabis Industry

We are advocates for cannabis legalization and want to see this industry grow and develop into one that is beneficial for all involved. We believe that cannabis can continue to be a force for positive change in numerous areas of society, from medicine to criminal justice to agriculture, and beyond. But, in order for it to do so, we must navigate issues such as those around pesticide use in an intelligent and responsible manner.

Our primary recommendation should be preceded by the statement that the use of chemical pesticides of the type triggering Colorado’s recalls is not needed in cannabis production. We make this statement based on years of experience working in, managing, and advising cultivation operations of all types, methodologies, and scales on how to grow successfully without illegal pesticides. Cannabis has survived and flourished throughout human history without pesticides, and will continue to do so if we cultivate it correctly.

As such, we recommend that growers n​ot​ employ any pesticides in a manner that violates label directions, and only use 25(b) products that have undergone pyrolysis testing to ensure that they are not releasing harmful compounds when burned. Furthermore, applications should only be made during the vegetative stage, prior to the emergence of flowers. Overall, if there is any doubt as to whether a product or material is safe, it should not be used until legitimate, peer­-reviewed research has been performed by a reputable institution.

Successful pest control can be achieved via intelligent facility design, robust environmental controls, workflow protocols, and strict cleanliness standards, in addition to preventative applications of appropriate minimum­ risk pesticides. There is no magic bullet that will solve all pest problems, which is why experienced agricultural professionals rely on Integrated Pest Management (IPM), defined as “an ecosystem­-based strategy that focuses on long­term prevention of pests or their damage through a combination of techniques such as biological control, habitat manipulation, modification of cultural practices, and use of resistant varieties.” Overall, the adoption of Good Agricultural Practices (GAP) is much needed in the industry, and cannabis growers should look to agricultural operations that promote the four pillars of GAP standards (economic viability, environmental sustainability, social acceptability, and safety and quality of the final product) for guidance in formulating best practices in this new field.

This recommendation is not simply a matter of principle, but one that will preserve your business. In addition to costly and brand­-damaging recalls, we have already seen the first product liability lawsuits filed last year against LivWell by cannabis consumers over off­label pesticide use. Another issue is that of worker safety. Most cannabis cultivation takes place indoors, where pesticide residues can linger in garden areas and on equipment, creating toxic work environments. Unfortunately, based on the widespread nature of pesticide use in the legal cannabis industry, we feel confident in stating that thousands of workers employed in legal cannabis cultivation operations have applied chemical pesticides without proper PPE or safety training. Businesses employing pesticides off­-label will likely find themselves subject to liability claims from workers, as well as consumers, in the relatively near future.

Conclusion

In closing, the bottom line is that applying pesticides off­-label is a violation of state and federal law and could result in criminal and civil sanctions, should regulators and affected parties choose to pursue them.

It must also be noted that off­-label pesticide use threatens the industry as a whole. Point six of the Cole Memorandum states that the federal government will not make the enforcement of the Controlled Substances Act a priority as long as the “exacerbation of (…) public health consequences associated with marijuana use” is prevented. The emergence of a public health problem would be a violation of the Cole Memo ­and it could be argued that the current situation unfolding in Denver is already a violation ­ and could trigger federal intervention against states that have legalized cannabis. In this light, the Denver Department of Environmental Health, which is driving the recalls, has not “launched a campaign against legal cannabis,” as a company recently subject to a recall claimed, but is actually acting as a bulwark against a potentially serious Cole Memo violation that could shutter the entire industry.

Based on the current situation, the cannabis industry must come together to denounce and eliminate off­-label pesticide use. In order to ensure the health of patients, consumers, workers, and the industry itself, we must seize this opportunity to grow without chemicals that are currently illegal, potentially very harmful, and ultimately not even necessary.