Tag Archives: farm

June 6, 2023

The Craft Cannabis Cavalry: A Story of Small Business & Economic Empowerment

By Aaron G. Biros

The Tohiyusdv Cavalry is a black-owned small business based in rural Virginia. At its core, they grow and process cannabis for CBD products, but it’s really much more than that. Through its Precision Craft Farmer Program, the company works with existing small minority-owned farms to introduce them to the cannabis market.

Via land leasing, profit-sharing, crop-sharing, facility design, community involvement and incubator-style support, Tohiyusdv Cavalry has built a network of farmers and a community around them that work together to gain access to the larger cannabis market.

Tohiyusdv, pronounced “toe-hee-yoos-da,” means “calm” and comes from a Native American dialect in the region. James Arrington III, founder of the company, is both African American and Native American, so the name is a nod to his roots. While Arrington insists he is just one part of this larger organization, it’s his passion for community, small business, social equity and cannabis that drives the company.

We sat down with James to learn more about the Tohiyusdv Cavalry, a bit of his background, how him and his community have found success and what they hope to achieve.

Different Sides of the Tracks

He grew up in Norfolk, Virginia alongside his two brothers and sister with a view of two different lifestyles. “We grew up in the hood of Huntersville, but I was raised in a white church, so it was interesting seeing both sides of the tracks and seeing the side that some of my friends couldn’t see,” says Arrington. The dichotomy of his upbringing gave him a unique perspective that he took to heart, eventually going to Old Dominion University for electrical engineering at the encouragement of a teacher.

Throughout his formative years, he didn’t really get involved with cannabis – that came much later. In his college years though, he met his Delta Chi fraternity brother Ernest Toney, who would go on to become the founder of BIPOCann, a nonprofit that helps social equity entrepreneurs, minority business owners and professionals in the cannabis industry.

Arrington with a recent indoor hemp crop

Working as an electrician to pay for tuition, Arrington graduated and launched what would become a successful career in electrical engineering. He worked as a subcontractor for the government in warzones, designing electrical systems with security and defense in mind, before starting his own company CalArr Consulting. “What really tied me to the industry was when I started using cannabis for my mental health and to understand who I am,” says Arrington. A combination of his upbringing and his career led to his PTSD, which then led him to cannabis as a tool for his wellbeing and mental health.

More recently, he spoke with Ernest Toney, who said, “Look man, I’ve seen what you’ve done with your business over the years and you should consider getting into the cannabis industry.” Arrington took that advice and ran with it. “So, the company I started is a mission-driven company based around healing, cannabis, understanding and helping people,” says Arrington. “Tohiyusdv Cavalry is based around working with small farmers and minorities; We introduce them to the cannabis industry.”

Here Comes the Cavalry

Right now, his company works with hemp and CBD products, but he says they are looking to expand into the THC market once Virginia legalizes and they already have some partners they’re working with in other states to expand the program.

Tohiyusdv Cavalry has been around for about two years now and Arrington says the heartbeat of it is their craft farmer program. “These are existing minority farmers in a community, already growing crops like soybean or corn,” says Arrington. “These are generational farms that have been passed down through family, some of them almost 100 years. They’ve always had to change with the times.” In changing with the times, a lot of these small, rural farms are seeing the hemp market as a possible pivot, but hardly know where to begin. “They are starting to hear about farmers in their community growing hemp, but having trouble finding folks to buy their crop.”

Some of the products from Tohiysudv Cavalry

That’s where the Cavalry comes in. “What you see in minority backgrounds is a lot of opportunities like this that are very scary to step into,” says Arrington. “We’re teaching people how to get into the industry, helping them through processing and getting on the market using new technology, and we do it at their pace.” Some folks in their network just want to rent space on their farm out to a hemp grower, others want to dive right in and create CBD products. They operate a white label program for some and help set up turnkey facilities complete with extraction and processing for others. “We work with them to build a community around their farm,” says Arrington. “We are just the engine behind these small farmers helping them get access to the larger market.”

From the Ground Up

A good example of the work they put in is Everbreeze Acres. Based in Rustburg, Virginia, Everbreeze is a 434-acre farm and bakery that’s been in the same family for generations. They had an interest in the cannabis market, so they approached Tohiyusdv Cavalry. James and his crew came in and built a 2,000-square-foot facility that is hydroponic, fully turnkey and automated. “We are teaching them the process and turning it over to them,” says Arrington. “We are teaching them how to take care of the plants, grow the crop, harvest and process it, all while collecting data.”

Before brainstorming how they want to market their products and how they want to be represented, the owners of the farm were still a little skeptical. Being in their 70s, they wanted to make a product that has some medicinal properties and could help people take care of themselves. So, James and his team put together a plan to launch a daily supplement, akin to a multivitamin.

Now Everbreeze Acres is using CBD as a megaphone to communicate their story. They were wary at first, but learned about it, grew to like it and now run a fruitful cannabis business. “We have their facility up and running and we’re growing several strains that work best for them right now,” says Arrington. “We’re about a month away from another harvest there.”

Building Community

Everbreeze Acres embodies the concept of the Tohiyusdv Cavalry. Helping small farmers establish themselves in the cannabis industry, building community around them and working to help their following and their mission.

Small business is the keystone of many communities, the cannabis industry included. Economic empowerment is sort of a way of staving off big business too. Given the history of big tobacco in the Virginia area, many stakeholders are worried if they’ll still have a seat at the table when Virginia legalizes adult use cannabis. “Looking at it in that sense, we are hoping that creating this group of diverse minds and backgrounds is building a table where everyone can sit at,” says Arrington. “We want to provide that place for them and let them know that, yes, this is the room for you, this is the place for you. We’re lending a helping hand and giving them a voice and a megaphone, sharing what they want to see in this industry.”

When asked what advice James would give himself ten years ago, the mood was somber. “Ten years ago, my mentor, alumni Dave “BamBam” Hoffman died. I would say that was the thing that gave me that kick in the ass, that I wasn’t doing everything I could do.” He has the same advice for minorities and indigenous people getting into the industry now: “Don’t be afraid to do it, the skills that you have you can put into the industry in some way. Your fit is out there. If it’s the right way, it’s never going to be easy. Push through it, keep going,” he says.

Growing in Virginia

Tohiyusdv Cavalry is ready for the day that Virginia legalizes adult use cannabis, but James says he hopes they make room for the small farmers. “Small farmers are what makes Virginia, Virginia.” They are in talks with some larger medical cannabis companies about creating similar programs for sourcing from craft growers. Through their strategic partners, a big part of their work right now is around partner and sponsor outreach, getting more businesses interested in sponsoring facilities and investing with small farmers. “Our hope is that we’ll be able to keep expanding the program and involve more minority farmers in Virginia and that it will only keep growing,” he says. “We’re optimistic that we’ll have three more farms signing on this year. And hopefully when Virginia legalizes adult use cannabis soon, we’ll be ready to expand in that market and keep on growing.”

May 24, 2022

New York Adds More Conditional Cultivation Licenses

By Cannabis Industry Journal Staff

No Comments

Regulators in New York are continuing their push forward in launching the adult use cannabis market. They have approved 58 conditional licenses for hemp growers to begin cultivating cannabis for the adult use market. In just the past few months, the state has already awarded 146 conditional licenses for cultivation.

The Office of Cannabis Management (OCM) in New York also announced their “Get Ready, Get Set” virtual workshop series, designed to help social equity applicants prepare for license applications and better understand the conditional licensing program.

Earlier this year, following an amendment to state law, the OCM launched the conditional licensing program to ensure that hemp farmers in the state with a desire to grow adult use cannabis could get started in the 2022 season.

Applications can be filed with the OCM for conditional licenses through June 30, 2022, with a $2,000 non-refundable application and licensing fee. The licenses are only for farms that have already grown hemp in New York State.

“New York is building the most inclusive cannabis industry in the country and including small farmers with an expertise is an essential component in accomplishing that goal,” says Chris Alexander, executive director at the OCM. “The growing season isn’t waiting for anyone and I’m grateful for the hard work of the CCB and my colleagues at OCM to ensure these licenses are being reviewed as quickly as possible so New York’s farmers can take full advantage of the growing season and cultivate the products that our equity entrepreneurs will be the first to sell when they open their dispensaries this year.”

February 22, 2022

Going Vertical: How Vertical Farming Is Revolutionizing the Cannabis Industry

By Jeffrey L Garber

1 Comment

In the cannabis industry, it’s crucial to be able to predict the future, to adapt and survive in a competitive industry that is arguably regulated more closely than any other.

From licensing to buildout, there are a growing number of barriers to entering the cannabis industry as a cultivator. Those who are lucky to successfully establish a grow operation are well aware that one of the crucial hurdles is managing space to maximize facility efficiency and capacity.

To stay profitable, the more plants you can grow and harvest at a time in a continuous cycle, the better. From an economic and environmental perspective, managing cost, space and time comes down to automation and efficiencies. One of the most efficient ways we optimize is through the practice of vertical farming.

Vertical farming maximizes canopy square footage while minimizing Cost of Goods Sold (COGs) to produce high-quality cannabis at scale year-round, and the industry is slowly finding that this method is an incredibly efficient and profitable way to maximize cannabis output.

Yellow Dream Farm is our family-owned cannabis cultivation, manufacturing and distribution company based in San Bernardino County, California, often known as the Silicon Valley of cannabis. Our craft, boutique-style cannabis is grown from floor to ceiling in the 30,000-square-foot facility. We’re using cutting-edge technology that’s only come to market in the last five years and using a variety of sustainable practices. With environmental and feeding efficiencies, we’re able to harvest 300 pounds per week when compared to 150 pounds per week from a facility of the same size.

Vertical Farming for Space Optimization

Like any medical field, cannabis has seen large numbers of outside investments into the space, bringing ideologies and efficiencies from other time-tested industries. One such efficiency is vertical farming – a practice already seen in large-scale agriculture.

The Yellow Dream Farm vertical cultivation facility

We choose vertical farming to maximize our canopy square footage and minimize COGs to produce high-quality cannabis at scale. The barrier to entry into the cannabis industry is expensive, and you must utilize every square inch to stay profitable. We believe vertical farming is the most efficient and most profitable way to maximize output and our numbers can back that up; for example, we can produce double the amount of flower than the average single-tier room with the same square footage, without doubling the cost.

Our rooms contain double stacks to double room capacity by using ceiling heights instead of square footage. Even though vertical farming has larger start-up costs, we can maximize square footage and output, allowing us to get a better and faster ROI. Vertical farming can be done in many different ways but the way we built our facility was always with a sustainable outlook. We also look to improve and remove human error; with full irrigation control and crop steering technologies, we can recalibrate sensors, irrigation media and environmental sensors when needed based on successes, challenges or environmental constraints. Additionally, we have a few other sustainable practices that make a difference.

Water Conservation, Lighting and Automation

Being a California-based grower, water conservation is a key part of our operations. With San Bernardino County being located in the heart of the high desert, conserving water is not only a requirement but a competitive advantage. Our practices provide cost savings which we then pass along to our customers. Each cannabis plant on average requires between a half gallon and one gallon of water per day, which we then recirculate through condensate water from our A/C and dehumidifiers. All runoff nutrient water is re-filtered and reused to get the most out of our nutrients before discarding waste. Our freezer panel walls hold temperatures at consistent rates, and we have a fully automated system to dial in specific needs at any given time.

LED lights above a crop at Yellow Dream Farm

Lighting is another major environmental and capital cost. Our primary lighting system is LED technology, and we use LED spectrums to find which spectrum benefits the plant most. With LEDs, our energy consumption is 30 percent less.

Vertical Farming Is the Future of Cannabis and Agriculture

Vertical farming has been hailed as the future of many agricultural industries and cannabis is no different. We already see large vertical farms in most legal states, but surprisingly it’s still not a common style of growing. As the price per pound steadily declines in California, being able to keep COGs down will allow vertical farmers to sustain and thrive in this volatile industry.

In order to adapt, grow and leave a positive mark on the industry, we must pave the way for new styles of growing and utilizing new technology and science that was not available to growers in the past. We can use these advanced new technologies to make real-time changes to each sector of our facility and optimize both people power, and energy efficiency. And most importantly, we’ll be able to produce top-quality cannabis for adults to enjoy at affordable prices.

For more information, visit Yellow Dream Farm.

June 23, 2021

Essential Elements to Set Up a Green, Zero-Waste Grow Facility

By Anthony Franciosi

1 Comment

Clean, ecologically sound production methods are the ideal for any cultivation or farming activity. Taking from the earth only what is needed to grow the crop and leaving behind little in the way of chemicals and land/water loss is the goal; with cannabis grow facilities, it can also be a reality.

This type of production does require some capital investment into state-of-the-art equipment and facilities, with standards that are equal to or even surpass current EPA and USDA regulations. While cannabis growing does not yet have access to the organic certification, that doesn’t mean growers can’t abide by and even go beyond the rules, to grow clean, healthy and environmentally sound cannabis.

There are a few essential elements required to make this kind of operation a reality.

Ecologically advanced use of power

For any indoor facility, one of the key elements is lighting. Using as energy efficient a system as possible is key. The best option at the moment is LEC lighting, which provides a spectrum of light that is very close to natural. This makes checking on plant progress more realistic and, with the inclusion of UV-B in the spectrum, can improve yields as well. In addition, the LEC bulbs have a long life—up to 2 years—which means lower maintenance costs as well.
The demand for high-quality, organically grown cannabis continues to increase

Another aspect of growing that tends to use a lot of power is the cooling system. A standard HVAC system will be power intensive, so alternative ones like water chilled climate control systems are just as effective and 30% more power efficient. These systems are also able to reuse wasted power by feeding it back into the system, creating an additional 10% energy reduction. In addition, when the outdoor air temperature dips below 45 degrees, a water chilled system can switch to using the outside air, creating 60—70% in energy savings.

Efficient management of water resources

Cultivators depend heavily on water to ensure that the plants are hydrated and able to absorb the nutrients they need to grow and thrive. The result for many however is an excessive waste of water. This is a problem when a grow facility is leveraging municipal water resources. A water meter helps to manage and track usage but to ensure that it is used as efficiently as possible, a “top feeding” method of usage ensures minimal water waste (5% or less).

Effective waste management

Wastewater is a byproduct of any water intensive cultivation method but there again, managing the systems to ensure that what water isn’t reused and becomes “gray water” is still as clean as possible is the ideal. A high-quality filtration system keeps sediment, chlorine and other harmful elements out of the water supply — and out of the municipal sewage system. Further, by using organic matter throughout the growing process, the wastewater that is produced will meet every federal standard for organic food production.
All plant waste in a grow facility—for example: stems and fan leaves—is disposed of according to state and local laws. With cannabis plants, that requires a certain level of security, including locked dumpsters that are only unlocked and placed outside when the removal trucks arrive on site.

Organic farming practices

Using OMRI (Organic Materials Review Institute) listed soil is an essential part of clean, environmentally friendly growing. To ensure the proper nutrients are available for each harvest, once a crop is gathered, the soil is transferred to a local landscape company to compost and reuse.
Pesticides need to obviously be avoided and all fertilizers need to be USDA approved as organic and all nutrients need to be certified by OMRI to ensure they don’t contain any synthetic materials.

Considering all of these aspects is essential to creating an ecologically friendly grow facility with tremendous yields that are clean and safe for the end consumer, as well as minimizing the impact to the earth.

March 23, 2021

National Ag Day: An Interview with Industry Leaders Disrupting Agriculture in Positive Ways

By Aaron Green

No Comments

National Agriculture Day (March 23, 2021), is an annual event held by the Agriculture Council of America (ACA), a not-for-profit 501-c (6) organization, to increase the public awareness of agriculture’s vital role in our society.

The ACA believes that every American should:

Understand how food and fiber products are produced.
Appreciate the role agriculture plays in providing safe, abundant and affordable products.
Value the essential role of agriculture in maintaining a strong economy.
Acknowledge and consider career opportunities in the agriculture, food and fiber industry.

We investigated how the hemp and cannabis industry is disrupting agriculture in positive ways, from automated trimming, to controlled environment agriculture, to water conservation and beyond. We interviewed Aaron McKellar, CEO and President of Eteros Technologies, parent company of Mobius Trimmer and Triminator, Mark Doherty, Executive Vice President of Operations, urban-gro, Inc. and Derek Smith, Executive Director at Resource Innovation Institute (RII) to get their perspective on agricultural innovation.

Aaron McKellar, CEO and President of Eteros Technologies

Aaron Green: Why is hand-trimming inefficient at scale?

Aaron McKellar: Hand-trimming is inefficient at scale because it is so labor-intensive and time-consuming, not to mention repetitive and frankly boring. It’s hard to stay fully engaged as a worker trimming by hand, so the consistency of your finished product isn’t reliable with a crew of hand-trimmers.

Aaron McKellar, CEO and President of Eteros Technologies

A hand-trimmer can produce good quality trim on about 2 or 3 pounds per day. A scaled-up facility running just one Mobius M108S Trimmer can realize up to 120 pounds per hour, replacing many dozens, or even into the hundreds of hand-trimmers. The HR nightmare this presents, and all the associated costs of paying and facilitating dozens of employees (parking, washrooms, lunchrooms, PPE and gowning, etc) is simply unworkable. And that’s before COVID.

Green: How does automated trimming benefit large producers and how does the quality compare to hand-trimming?

McKellar: Not all automated trimmers are created equal. Any of the machines out there will help to reduce the need for hand-trimmers by taking off the bulk of the leaf, leaving a small team of “hand-polishers” to finish it up. The Mobius Trimmer is the only automated trimmer on the market today that leaves the technology of the original machines in the past and employs next-gen technology to truly mimic hand-trimmed quality with stunning through-put rates.

We have high-end producers using Mobius Trimmers whose own QC department cannot discern Mobius-trimmed flower from hand-trimmed flower. Hand polishing crews tend to be far smaller when using a Mobius vs first-gen machinery, and many Mobius users don’t touch up at all, instead going straight to market right out of the trimmer. For a look at how our technology differs from the rest of the field, check out this look under the hood.

Mark Doherty, Executive Vice President of Operations, urban-gro, Inc.

Aaron Green: What is controlled environment agriculture?

Mark Doherty: Cannabis cultivators understand growing indoors because, prior to legalization, they had been doing it for years in the gray market. It is by way of that experience that cultivators learned how to manipulate a highly-valuable, complex plant in an indoor setting. As cannabis legalization spread across the United States, many government regulators required that it be cultivated indoors according to strict regulatory protocols. Fast forward 10 years, and we have an industry that is keenly aware of the indoor environmental conditions required to be successful. Critical factors like heating, cooling, ventilation, dehumidification, and how to best mimic Mother Nature’s energy through lighting are all deliberately optimized.

Mark Doherty, Executive Vice President of Operations, urban-gro, Inc.

With cannabis cultivation driving the advancements of controlled environment agriculture, market and regulatory forces demanded higher efficiency, reduced energy and resource consumption, and clean crops. In most states, cannabis crops have more stringent testing than food crops. For instance, the lettuce in Massachusetts will not pass the standards for cannabis in Massachusetts. It’s through rapid innovation and technology adoptions that the cannabis industry has paved the way for lettuce to be profitably grown indoors.

Green: How can controlled environment agriculture help alleviate supply chain stresses?

Doherty: By growing food closer to the consumer, you reduce food miles; meaning, that link in the food supply chain gets a lot shorter and is less prone to disruption. Whether you have hyper small cultivation facilities on every street corner, or a larger cultivation facility geographically close to consumers, you can grow 24/7/365. Furthermore, growing locally allows for better prediction of facility output—10 boxes of greens on Monday, 50 boxes of greens on Tuesday, and five boxes of greens on Thursday. This eliminates harvesting a large crop before it is ripe and likely requiring cold storage. The controllability of controlled environment ag is that consistent, reliable contribution to the food supply chain and shortening that path to the consumer.

Derek Smith, Executive Director at Resource Innovation Institute (RII)

Aaron Green: What motivated you to publish the Cannabis H2O: Water Use and Sustainability in Cultivation report?

Derek Smith, Executive Director at Resource Innovation Institute (RII)

Derek Smith: Until this report, if you searched for cannabis water usage, you’d basically find one cited statistic. It was “six gallons per plant per day.” We knew this was from a model based on one extreme illicit market scenario. Based on the data we were seeing and the conversations we were having, this number seemed way off. So, we pulled together a multidisciplinary Water Working Group as part of our Technical Advisory Council. The objective of the Water Working Group was to establish a scientific understanding of how, and how much, water is used for cannabis cultivation so that cultivators have confidence in taking steps to be more efficient, and so that industry leaders, governments and media can be accurately informed about the range of water practices of today’s regulated market.

Green: What key points should cannabis cultivators take away from the report? What key points should regulators and policymakers take away from the report?

Smith: As the cannabis industry matures, water use efficiency will become more important, as it has for other agricultural crops. Pressures to use water efficiently will mount from multiple channels including – reducing input and energy cost, protecting the environment, meeting regulatory standards and simply being good stewards. We recommend that industry and regulators focus efforts on the following areas:

When grown outdoors, water for cannabis production should be assessed like any other agricultural crop and be subject to state and local regulations that apply to other crops. Our research indicates that cannabis neither uses a massive share of water nor uses more water than other agricultural crops. Applying the same standards to cannabis as to other agricultural crops will correctly categorize outdoor grown cannabis as an agricultural crop.
In areas where there may be conflict between water use for cannabis and environmental concerns, regulators and the industry should focus (1) on the timing of water use and (2) the potential of storage to mitigate environmental conflict. Our results show that in many parts of the country legal cannabis farmers have ample water storage to satisfy their needs. In areas where storage is insufficient, increasing storage should be a priority for farmers and regulators.
Our research shows there are still massive differences between cannabis production techniques. As farmers continue to experiment and improve, we expect to see water use be a more important part of cannabis farming decisions and expect new plant varieties and growing techniques to be developed that increase water use efficiency. Yet more data from actual farms and facilities are needed to point the way toward the technologies and techniques that drive optimal efficiency and productivity. It is recommended that producers benchmark their performance and governments consider requiring energy and water reporting by producers. The Cannabis PowerScore can assist in these efforts.
As indoor production continues to grow, especially in areas that have unfavorable climatic conditions for outdoor growing, we expect more cannabis users to rely on municipal water sources. Yet, it is unclear if municipal water suppliers are equipped to work with the cannabis industry. We suggest outreach efforts between the cannabis industry and municipal water suppliers to incentivize efficiency where possible.

March 23, 2021

Flower-Side Chats Part 3: A Q&A with Harvey Craig, CEO Harvey’s All Naturals and Co-Founder of Boot Ranch Farms

By Aaron Green

No Comments

In this “Flower-Side Chats” series of articles, Green interviews integrated cannabis companies and flower brands that are bringing unique business models to the industry. Particular attention is focused on how these businesses integrate innovative practices in order to navigate a rapidly changing landscape of regulatory, supply chain and consumer demand.

Large-scale agricultural practices can take a toll on soil health leading to inefficiencies over the long term. Harvey’s All Naturals is a Colorado-based company specializing in premium farm-to-table full spectrum CBD products. Harvey’s gets all of its hemp from Boot Ranch Farms, an off-grid sustainable hemp farm in Southern Colorado supplied by an artesian well.

We spoke with Harvey Craig, CEO Harvey’s All Naturals and co-founder of Boot Ranch Farms, to learn more about the benefits of regenerative agriculture, how he thinks about soil health, and how they produce their CBD products. Harvey started Boot Ranch Farms in 2014 after the passing of the Farm Bill and Harvey’s All Naturals followed shortly thereafter.

Aaron Green: How did you get involved in the cannabis and hemp industry?

Harvey Craig: I got involved at a very young age, as the youngest of eight kids, seven of which are boys, I was introduced to cannabis on the marijuana side first. As an engineer through the years, I’ve always been involved in creating very efficient growing systems for cannabis.

In the early 2000s, I learned about CBD a little bit through experimenting with marijuana strains to help a friend who had Parkinson’s and also through the research performed by Raphael Mechoulem, an organic chemist and professor at the Hebrew University of Jerusalem in Israel. In 2014, when the Farm Bill made hemp legal, I dropped everything and went into it because I felt “this is what I need to be doing.”

Green: What is sustainable farming mean to you?

Craig: Sustainable farming to me means putting soil health and responsible natural growing practices at the forefront of all agriculture – regenerative processes for soil, in a nutshell. To me, soil health is one of the biggest problems in the United States right now. By regenerating and making our soils living, healthy and with a rich nutrient base we create an ecosystem that is good for human health and health all around.

Green: What do you mean specifically when you say, “soil health?”

Craig: Soil is living. A good natural soil has a living microbiotic structure inside it. There’s a living habitat that forms inside our soil over the years. Large scale agriculture in many cases has depleted or killed this living structure through readily accessible fertilizers and tilling practices.

Farmers understand the soil. There are practices we can undertake that are helping our living soils and helping the microbiotic habitat to thrive. Practices such as no-till technologies, rotating crops, using cover crops, not being a monocrop, responsible water use, healthy fertilizer and pesticide technologies, minimal processing, the list goes on and on…

When we talk about this thing called sustainability, I think it’s very important that we understand there are two sides of cannabis. There’s the marijuana and then there’s the hemp. We can’t put those two together – they’re governed very differently. Hemp became legal through the Farm Bill and is governed by the Department of Agriculture. Hemp is just like any other crop out there really. That means we can mix hemp in with other crops. It’s very much like corn and other crops in how it’s grown on a large scale, industrial basis.

Marijuana on the other hand is governed by each state’s regulatory commission. Those regulations make it very hard to mix in with general agriculture. So, when it comes to the marijuana side, unfortunately, it must be a monocrop. Most marijuana is grown in pots and pots are fine. However, if you are just growing in a pot and then throwing your soil away, that is not very sustainable. As it sits right now, in the marijuana industry there is really no sustainability, unfortunately. The energy use for the lights in indoor grows, for example, creates a huge carbon footprint and load on the electrical grid. I’m not trying to put indoor growing down, but that’s the way it is. The only way I foresee sustainability in the marijuana side of cannabis is to let loose a little bit on regulation and allow it to become a part of normal agricultural processes.

Green: What is it about tilling that degrades the soil quality?

Craig: When we till our soil, we’re turning the organisms in the soil up and we’re allowing the sun to dry them out. If it’s not done properly, you kill that soil structure.

Now, these little microorganisms in our soil create a healthy soil, but it doesn’t happen instantly, this takes years to create. Nobody has the time anymore, everybody’s “go go go” and “make it happen instantly”. So that gets destroyed. Now we have all these dead soils that everybody’s growing in and growers turn to factory-produced fertilizers with readily available nutrients.

When we are talking about cannabis, we can’t just look at monocropping. If you grow one crop in the same soil over and over, the soil is going to get depleted. One of the main things that we deplete is nitrogen and growing other crops, such as clover, can replenish that nitrogen. Growing cover crops protects the soil from the sun, creates nitrogen for the soil, and holds the water within the soil.

Instead of tilling, you can rotate with crops like root vegetables, radishes and other things that have deep root structures. Instead of tearing them up, just let them degrade organically and go back into the soil. Those deep root structures will also help aerate the soil.

Green: What is a farmer’s first approach?

Craig: Farmers want their land to be healthy. True farmers have a oneness with the earth and understand the earth. The farmer’s first approach keeps the farmer involved in creating new technologies for agriculture.

Green: Let’s say you’re a farmer that has land or recently acquired land that’s been industrially grown upon. How would you take that land and start fresh with a regenerative process?

Craig: The first thing you have to do is take soil samples and send them to a lab. That’ll tell you what you’re working with. Also, knowing a little history about the land helps as well. Was it used for grazing? Was it used for growing corn? What was it used for? Were organic practices used?

Then, there are many things you can do to start to regenerate your soil, but it takes time. In many situations, people don’t want to take that time. But what we’re learning is, the people and the farmers that do take that time often take a hit monetarily for the first two or three years. After that, once that structure is maintained, the natural health of the soil can be replenished. Crops will grow better, and they won’t spend as much money on fertilizers and pesticides in the long run because the microbiotic structure in the soil is creating a healthy ecosystem. When we destroy that ecosystem, it doesn’t come back easily or quickly. If there’s a little bit there, it can be regenerated with the right practices.

Green: I understand that the Boot Ranch is an off-the-grid farm. What was your motivation for either going off-grid or remaining off-grid?

Craig: I have a background in alternative energies and engineering, and when creating Boot Ranch Farms there was a lot that went into the sustainability side of it. The farm is extremely far away from the power grid for starters. So, an investment in solar for electricity was money well spent. My thought process was, why would I invest in bringing the wires in when I could actually save money and resources by creating a very efficient solar system and not be tied to the grid? Our farm is self-sustaining without being connected to any grid, which is one of the main reasons for remaining off-grid.

Green: I understand the farm is supplied by an artesian well. How do you monitor your water quality?

Craig: Well, we’re very fortunate. Existing natural water quality is one of the main reasons we decided to grow in the San Luis Valley. When you’re starting something new, you have to look at your financial side of things. Investing in a hemp farm is very different than the marijuana side because you won’t make as much money per pound of product sold. So, you have to watch your budget and not spend too much, or you’re never going to make a profit.

The self-sustaining artisanal well and water rights were existing on the property. There’s no pumping required for it and the water goes into a 10,000-gallon holding tank, where we can monitor and test for water quality. In order to water our plants, we use a pump/drip water system that supplies water to each individual plant. It’s very efficient compared to most watering systems out there, such as flood irrigation or pivots, and really doesn’t use a heck of a lot of water.

Green: Are you growing in open air or greenhouses?

Craig: We grow in two 3,000 square feet industrial-grade greenhouses at Boot Ranch Farms. Greenhouse One has all the bells and whistles including heating, cooling, light deprivation, supplemental lighting, automated controls and more. That greenhouse allows us to mimic Mother Nature a little bit. We can get up to six harvests throughout the course of the year in that greenhouse. However, in reality, we get about four.

In addition, we have a second greenhouse that is set about 100 feet away and set up to keep plants growing on mother nature’s cycle. We can move groups of mature plants to Greenhouse One after each harvest for multiple flowering cycles. Lastly, between greenhouses, we have a 10,000 square foot courtyard that’s protected with shade cloth and other things to help protect those plants from the elements. In late October, all remaining plants in both greenhouses and the courtyard become mature and ready to harvest due to shorter days created by mother nature.

Green: Do you insure your crops?

Craig: We have not. Hemp is a new industry and we have not found good crop insurance.

Green: Do you cultivate your own genetics?

Craig: We work with some other companies here in Colorado to provide genetics. Consistent genetics are extremely important on the hemp side because we need to trust that they are going to keep the THC levels down. On the marijuana side, that part doesn’t matter so much

There are different strains that have been created that I absolutely love, and I’ve tried to stick with them and stay with that seed stock. One of them is called The Wife and the other Cherry Wine. Most of the best hemp I have found is based upon the Cherry strain. People are always looking for high CBD. I’d rather have a lower CBD level in the 8% to 12% range. Something higher in the 14% to 20% range has a higher chance of producing a product with more than the legal amount of THC.

Green: Is Harvey’s All Naturals fully supplied by Boot Ranch Farms?

Craig: Yes, it is. There are a lot of things that go into a quality product and we focus on that at Boot Ranch. We’re small, not trying to compete with the large-scale market. Unfortunately, a high percentage of the products out on the market come from large-scale industrial hemp grows. We focus on long-term medicinal value and grow very high-quality hemp and we try not to degrade it in any way, shape or form throughout processing.

Green: How many square feet or acres is the Boot Ranch Farm?

Craig: Boot Ranch farm is about 260 acres. We only grow on less than three of it.

Green: What’s your extraction process?

Craig: We use cold alcohol extraction. We do not distill to separate our alcohol from the hemp oil. We use what’s called a roto vape. That cold processing preserves our terpenes, it preserves our full-spectrum cannabis oil profile and doesn’t fully decarboxylate our CBDa. We want a large CBDa percentage because there are many things that CBDa is good for when it comes to long term medicinal reasons.

Green: Are you processing your own hemp?

Craig: No, we sub that part of it out. What I’ve learned in this industry is three main parts: 1- the farming; 2- the extraction, and; 3- the product line. Those are three very separate processes and require specialized expertise within themselves. Each is a large investment and it’s very hard to do it all. I decided to work with other people on the extraction part of it. They have the expertise, and we pay them well to do what they do.

Green: Okay, great. And then any final words for Ag Day?

Craig: Support your small farmer in nutrient-rich agricultural products.

Green: Great. That concludes the interview, Harvey!

Craig: Thank you very much!

March 10, 2021

Mark Your Calendars: The Cannabis Cultivation Virtual Conference Returns

By Cannabis Industry Journal Staff

No Comments

On March 23, 2021, Cannabis Industry Journal is hosting our annual Cannabis Cultivation Virtual Conference. From Noon to 5 pm EST, you’ll get access to nine veterans of the cultivation market discussing a variety of topics related to the ins and outs of growing cannabis and hemp.

Hear from subject matter experts who will share their perspectives on growing organically, facility design and planning, hemp farming and integrated pest management.

Back in December during the Cannabis Quality Virtual Conference, the Cultivation Technology episode featured a session titled A Panel Discussion: Integrated Lifecycle of Designing a Cultivation Operation. Due to a large amount of interest and attendee questions that the panel did not have time to address, we are reprising this panel discussion and bringing it back on March 23.

Speakers for that panel discussion include: Gretchen Schimelpfenig, PE, Technical Director of Resource Innovation; Brandy Keen, Co-Founder & Sr. Technical Advisor at Surna, Inc; Adam Chalasinski, Applications Engineer at Rough Brothers/Nexus Greenhouse Systems/Tetra; David Vaillencourt, Founder & CEO of The GMP Collective, and Kyle Lisabeth, Vice President of Horticulture at Silver Bullet Water.

Other talks from the Cannabis Cultivation Virtual Conference on March 23 include:

Why CBD Companies Should Go Organic
- Brad Kelley, COO of Socati
The Beginner’s Guide to Integrated Pest Management
- David Perkins, Founder of Floresco Consulting
Starting from Scratch: Launching a Hemp Farm in Georgia
- Reginald “Reggie” Reese, Founder & CEO of The Green Toad Hemp Farm
- Dwayne Hirsch, President & Chief of Business Development at The Green Toad Hemp Farm

You can check out the agenda in its entirety and register here. Attendees will have the opportunity to ask speakers questions during the live Q&A session that follows each session. Registration is complimentary. For sponsorship opportunities, contact RJ Palermo at Rj@innovativepublishing.net

February 11, 2021

New Guidance on Waste Disposal for Hemp Producers

By Stephanie McGraw, Emily Sellers

No Comments

On January 15, 2021, the USDA published its final rule on US hemp production. The rule, which becomes effective on March 22, 2021, expands and formalizes previous guidance related to waste disposal of noncompliant or “hot” crops (crops with a THC concentration above .3 percent). Importantly for the industry, the new disposal rules remove unduly burdensome DEA oversight and provides for remediation options.

Producers will not be required to use a DEA reverse distributor or law enforcement to dispose of noncompliant plants. Instead, producers will be able to use common on-farm practices for disposal. Some of these disposal options include, but are not limited to, plowing under non-compliant plants, composting into “green manure” for use on the same land, tilling, disking, burial or burning. By eliminating DEA involvement from this process, the USDA rules serve to streamline disposal options for producers of this agricultural commodity.

Alternatively, the final rule permits “remediation” of noncompliant plants. Allowing producers to remove and destroy noncompliant flower material – while retaining stalk, stems, leaf material and seeds – is an important crop and cost-saving measure for producers, especially smaller producers. Remediation can also occur by shredding the entire plant to create “biomass” and then re-testing the biomass for compliance. Biomass that fails the retesting is noncompliant hemp and must be destroyed. The USDA has issued an additional guidance document on remediation. Importantly, this guidance advises that lots should be kept separate during the biomass creation process, remediated biomass must be stored and labeled apart from each other and from other compliant hemp lots and seeds removed from non-compliant hemp should not be used for propagative purposes.

The final rules have strict record keeping requirements, such rules ultimately protect producers and should be embraced. For example, producers must document the disposal of all noncompliant plants by completing the “USDA Hemp Plan Producer Disposal Form.” Producers must also maintain records on all remediated plants, including an original copy of the resample test results. Records must be kept for a minimum of three years. While USDA has not yet conducted any random audits, the department may conduct random audits of licensees.

Although this federal guidance brings some clarity to hemp producers, there still remains litigation risks associated with waste disposal. There are unknown environmental impacts from the industry and there is potential tort liability or compliance issues with federal and state regulations. For example, as mentioned above, although burning and composting disposal options for noncompliant plants, the final rule does not address the potential risk for nuisance complaints from smoke or odor associated with these methods.

At the federal level, there could be compliance issues with the Resource Conservation and Recovery Act (RCRA), Comprehensive Environmental Response Compensation and Liability Act (CERCLA) and ancillary regulations like Occupation Safety and Health Administration (OSHA). In addition to government enforcement under RCRA and CERCLA, these hazardous waste laws also permit private party suits. Although plant material from cultivation is not considered hazardous, process liquids from extraction or distillation (ethanol, acetone, etc.) are hazardous. Under RCRA, an individual can bring an “imminent and substantial endangerment” citizen suit against anyone generating or storing hazardous waste in a way the presents imminent and substantial endangerment to health or the environment. Under CERCLA, private parties who incur costs for removal or remediation may sue to recover costs from other responsible parties.

At the state level, there could be issues with state agency guidance and state laws. For example, California has multiple state agencies that oversee cannabis and hemp production and disposal. CA Prop 65 mandates warnings for products with certain chemicals, including pesticides, heavy metals and THC. The California Environmental Quality Act (CEQA) requires the evaluation of the environmental impact of runoff or pesticides prior to issuing a cultivation permit. Both environmental impact laws permit a form of private action.

Given the varied and evolving rules and regulation on hemp cultivation, it remains essential for hemp producers to seek guidance and the help of professionals when entering this highly regulated industry.

October 22, 2020

A Survey of State CBD & Hemp Regulation Since The 2018 Farm Bill

By Brett Schuman, Jennifer Fisher, Brendan Radke, Gina Faldetta

1 Comment

Since the December 20, 2018 enactment of the Agricultural Improvement Act of 2018, better known as the Farm Bill, we have seen a number of new state laws addressing both the legality of hemp and products derived therefrom, most noticeably cannabidiol, better known as CBD. This piece provides a brief overview of some of the more interesting state laws concerning hemp and CBD, as well as recent developments.

Legality of Hemp

Since the passage of the Farm Bill, the vast majority of states have legalized the cultivation and sale of hemp and hemp products. However, certain states maintain laws barring some or even most forms of hemp.

The most stringent of those states is Idaho, where hemp remains illegal. In March 2020, Senate Bill 1345 – legislation that would have allowed for the production and processing of industrial hemp – died in the House State Affairs Committee, due to concerns that legalizing hemp would be the first step toward legalizing “marijuana”; that the bill contained too much regulation and that it was otherwise unworkable. As a result, Idaho is currently the only state without a legal hemp industry. Hemp with any THC, even at or below the 0.3 percent threshold under the Farm Bill, is considered equivalent to “marijuana” in Idaho and is illegal (see below for a discussion of CBD in Idaho).

Indiana, Iowa, Louisiana, and Texas have enacted bans on smokable hemp. Indiana law prohibits hemp products “in a form that allows THC to be introduced into the human body by inhalation of smoke.” Iowa has amended its Hemp Act to ban products introduced to the body “by any method of inhalation.” Louisiana prohibits “any part of hemp for inhalation” except hemp rolling papers, and Texas law prohibits “consumable hemp products for smoking.”

Some of these bans have been challenged in court. In Indiana, a group of hemp sellers requested an injunction against the smokable hemp ban in federal court, on the grounds that the federal Farm Bill likely preempted the Indiana law. In September of 2019, the district court issued the requested injunction, but the U.S. Court of Appeals for the Seventh Circuit overturned that decision in July 2020, stating that the order “swept too broadly.” The Seventh Circuit noted that the 2018 Farm Bill “expressly provides that the states retain the authority to regulate the production of hemp” and remanded the case for further proceedings.

Similarly, in Texas, hemp producers have sued in state court over the smokable hemp ban, questioning its constitutionality and arguing that it would result in a loss of jobs and tax revenue for the state. According to those producers, smokable hemp comprises up to 50 percent of revenue from hemp products. On September 17, 2020, Travis County Judge Lora Livingston issued a temporary injunction blocking enforcement of the law until trial, which currently is set to commence on February 1, 2021. Judge Livingston had previously issued a temporary restraining order to that same effect.

State Laws Regulating CBD

State laws and regulation on hemp-derived CBD are varied, and the legality of a CBD product often comes down to its form and marketing.

As an initial matter, it must be noted that notwithstanding the Farm Bill the FDA currently prohibits hemp-derived CBD from being be sold as dietary supplements, and food (including animal food or feed) to which CBD has been added cannot be introduced into interstate commerce. As discussed below, a substantial minority of states, including California, follow the FDA’s current position on the permissibility of putting hemp-derived CBD in food or dietary supplements.

Certain states include strict limitations on CBD, none more so than (once again) Idaho. Lacking any legal hemp industry, Idaho restricts CBD products to those having no THC whatsoever, rejecting the generally accepted threshold of not more than 0.3 percent THC. Idaho law also requires that hemp CBD be derived only from “(a) mature stalks of the plant, (b) fiber produced from the stalks, (c) oil or cake made from the seeds or the achene of such plant, (d) any other compound, manufacture, salt, derivative, mixture, or preparation of the mature stalks, or (e) the sterilized seed of such plant which is incapable of germination.”

Kansas similarly prohibits CBD with any amount of THC, though the law is murkier than Idaho’s. While Senate Bill 282 allowed possession and retail sale of CBD effective May 24, 2018 by removing CBD oil from the definition of “marijuana,” this was broadly interpreted to apply to THC-free CBD only. Later legislation, Senate Substitute for HC 2167, effective July 2019, allowed the farming of hemp with THC levels aligned with the Farm Bill definition (i.e., 0.3 percent THC or lower), but expressly prohibited the use of industrial hemp in: cigars, cigarettes, chew, dip, or other smokeless forms of consumption; teas; liquids for use in vaporizing devices; or “[a] ny other hemp product intended for human or animal consumption containing any ingredient derived from industrial hemp that is prohibited pursuant to the Kansas Food, Drug and Cosmetic Act or the Kansas Commercial Feeding Stuffs Act,” though this final section provides that “[t] his does not otherwise prohibit the use of any such ingredient, including cannabidiol oil, in hemp products,” the law’s only reference to CBD. The Kansas Bureau of Investigation has reportedly made statements indicating that CBD with any level of THC remains illegal.

Mississippi only recently legalized the cultivation of hemp via Senate Bill 2725, the Mississippi Help Cultivation Act, which was signed into law on June 29, 2020. House Bill 1547, passed on April 16, 2019, imposed content requirements upon CBD products within Mississippi: to be legal in Mississippi, a CBD product must contain “a minimum ratio of twenty-to-one cannabidiol to tetrahydrocannabinol (20:1 cannabidiol:tetrahydrocannabinol), and diluted so as to contain at least fifty (50) milligrams of cannabidiol per milliliter, with not more than two and one-half (2.5) milligrams of tetrahydrocannabinol per milliliter.” Moreover, CBD products produced in Mississippi must be tested at the University of Mississippi’s lab. However, subject to these restrictions, Mississippi allows the sale of CBD products, including edibles, contrary to the restrictions of many of states considered friendlier to hemp.

Perhaps more surprising is Hawaii, which restricts the sale and distribution of CBD, aligning with the FDA’s guidance. In Hawaii it is illegal to add CBD to food, beverages, as well as to sell it as a dietary supplement or market it by asserting health claims. It is also illegal to add CBD to cosmetics, an uncommon restriction across the many states with CBD-specific laws and regulations. Unlike Idaho and Mississippi, which have no medical marijuana programs, Hawaii has long legalized marijuana for medical purposes and in January 2020 decriminalized recreational possession. Hawaii very recently enacted legislation allowing the production and sale of cannabis-infused consumable and topical products by medical cannabis licensees effective January 1, 2021, but this legislation did not address CBD. Given the foregoing, Hawaii’s restrictions on CBD stand out.

The structure of cannabidiol (CBD), one of 400 active compounds found in cannabis.

Beyond broad CBD restrictions, many more states prohibit the use of CBD within food, beverages, or as dietary supplements. For instance, twenty states – including California, Georgia, Illinois, Massachusetts, Michigan, New Jersey, New York, and Washington – prohibit the sale of CBD in food or beverage. In California, a bill to overhaul California’s hemp laws, Assembly Bill 2028, failed when the legislative session concluded on August 31, 2020 without a vote. AB 2028 would have allowed CBD in food, beverages, and dietary supplements (though, interestingly, it would have banned smokable hemp). As a result, California remains a relatively restrictive state when it comes to hemp-derived CBD, notwithstanding the legality of recreational marijuana.

New York allows the manufacture and sale of CBD, but requires CBD products to be labeled as “dietary supplements.” This mandate conflicts directly with the FDA’s position that CBD products are excluded from the definition of a dietary supplement. Further, despite the state’s categorization of CBD products as dietary supplements, New York prohibits the addition of CBD to food and beverages. These regulations have resulted in a confusing landscape for retailers and manufacturers in the Empire State.

Several states also have labeling requirements specific to CBD products. Batch numbers and ingredients are ubiquitous, but an increasingly common requirement is the inclusion of a scannable code that links to specific information about the product. States imposing this requirement include Florida, Indiana, Texas, and Utah. Indiana is viewed as having one of the more comprehensive labeling requirements for CBD products – or, depending upon your perspective, the most onerous.

September 9, 2020

CBD Industry Caught Between Regulators & Law Enforcement

By Gregory S. Kaufman

No Comments

The consumer-facing CBD industry operates in a regulatory gray zone even as it grows in prominence. Illegal to market as an unapproved drug, dietary supplement or food additive under the Food, Drug & Cosmetic Act, nevertheless, the CBD industry has flourished with ingestible products widely available. With the increased consumer interest in CBD, headwinds in the form of mislabeled or contaminated products and unsubstantiated therapeutic claims, combined with regulatory uncertainty, continue to be a drag on legitimate market participants and consumer perception of CBD products. The regulation of hemp-derived CBD falls under the purview of the Food and Drug Administration (FDA) and its charge to protect the public health. Despite having jurisdiction to regulate CBD products, the FDA has done little to bring regulatory certainty to the CBD marketplace. However, the FDA, with the assistance of the National Institute of Standards and Technology (NIST), recently took important steps that can be described as “getting their ducks in a row” for the eventual regulation of hemp-derived CBD in consumer products. Always looming is the threat of criminal enforcement of the Controlled Substances Act (CSA) by the Department of Justice’s Drug Enforcement Administration (DEA) for plants and products not meeting the definition of hemp.

Prior to July 2020, the FDA’s regulation of the CBD industry was limited to a public hearing, data collection, an update report to Congress on evaluating the use of CBD in consumer products, and issuing warning letters to those marketing products for treatment of serious diseases and conditions. The FDA recognizes that regulatory uncertainty does not benefit the Agency, the industry or consumers and, therefore, is evaluating a potential lawful pathway for the marketing of CBD products. In furtherance of this effort, the FDA took several recent actions, including:

Producing a CBD Testing Report to Congress¹
Providing draft guidance on Quality Considerations for Clinical Research²
Sending a CBD Enforcement Policy to the Office of Management and Budget for pre-release review and guidance³

Not to be overlooked, the NIST announced a program to help testing laboratories accurately measure compounds, including delta-9 tetrahydrocannabinol (THC) and CBD, in marijuana, hemp and cannabis products, the goal being to increase accuracy in product labeling and to assist labs in identifying THC concentrations in order to differentiate between legal hemp and federally illegal marijuana. These actions appear to be important and necessary steps towards a still be to determined federal regulatory framework for CBD products. Unfortunately, a seemingly innocent interim final rule issued by the DEA on August 21, 2020 (Interim Final Rule), may prove to be devastating to hemp processors and the CBD industry as a whole.⁴ While the DEA describes its actions as merely conforming DEA regulations with changes to the CSA resulting from the 2018 Farm Bill, those actions may make it exceedingly difficult for hemp to be processed for cannabinoid extraction without violating the CSA in the process.

FDA Report to Congress “Sampling Study of the Current Cannabidiol Marketplace to Determine the Extent That Products are Mislabeled or Adulterated”

On July 8, 2020, the FDA produced a report to the House and Senate Committees on Appropriations detailing the results of a sampling study to determine the extent to which CBD products in the marketplace are mislabeled or adulterated. The study confirmed what the FDA, Congress and the marketplace already knew – that in this regulatory vacuum, there are legitimate concerns about the characteristics of consumer CBD products. These concerns include whether products contain the CBD content as described in the label, whether products contain other cannabinoids (including THC) and whether products were contaminated with heavy metals or pesticides. With these concerns in mind, the FDA tested 147 CBD and hemp products purchased online for the presence of eleven cannabinoids, including determinations of total CBD and total THC, and certain heavy metals. The key tests results included the following:

94% contained CBD
2 products that listed CBD on the label did not contain CBD
18% contained less than 80% of the amount of CBD indicated
45% contained within 20% of the amount listed
37% contained more than 20% of the amount of CBD indicated
49% contained THC or THCA at levels above the lowest concentration that can be detected
Heavy metals were virtually nonexistent in the samples

Due to the limited sample size, the FDA indicated its intention to conduct a long-term study of randomly selected products across brands, product categories and distribution channels with an emphasis on more commercially popular products. In furtherance of this effort, on August 13, 2020, the FDA published a notice soliciting submissions for a contract to help study CBD by “collecting samples and assessing the quantities of CBD and related cannabinoids, as well as potential associated contaminants such as toxic elements, pesticides, industrial chemicals, processing solvents and microbial contaminants, in foods and cosmetics through surveys of these commodities.”⁵

Even though this report was not voluntarily produced by the FDA, rather it was required by Congress’ Consolidated Appropriations Act of 2020, it importantly solidified a basis for the need for regulation. With less than half of the products tested falling within the 20% labeling margin of error, this suggests rampant and intentionally inaccurate labeling and/or significant variability in the laboratory testing for cannabinoids.

NIST Program to Help Laboratories Accurately Measure Compounds in Hemp, Marijuana and Cannabis Products

Proper labeling of cannabinoid content requires reliable and accurate measurement of the compounds found in hemp, marijuana and cannabis products. As part of NIST’s Cannabis Quality Assurance Program, NIST intends to help labs produce consistent measurement results for product testing and to allow forensic labs to distinguish between hemp and marijuana.⁶ As succinctly stated by a NIST research chemist, “When you walk into a store or dispensary and see a label that says 10% CBD, you want to know that you can trust that number.” Recognizing the lack of standards due to cannabis being a Schedule I drug for decades, NIST intends to produce standardized methods and reference materials the help labs achieve high-quality measurements.

NIST’s efforts to provide labs with the tools needed to accurately measure cannabis compounds will serve as an important building block for future regulation of CBD by the FDA. Achieving nationwide consistency in measurements will make future FDA regulations addressing CBD content in products achievable and meaningful.

FDA Industry Guidance on Quality Considerations for Clinical Research on Cannabis and Cannabis-Derived Compounds

On July 21, the FDA released draft guidance to the industry addressing quality considerations for clinical research of cannabis and cannabis-derived compounds related to the development of drugs. These recommendations are limited to the development of human drugs and do not apply to other FDA-regulated products, including food additives and dietary supplements. However, by indicating that cannabis with .3% or less of THC can be used for clinical research and discussing testing methodologies for cannabis botanical raw material, intermediaries and finished drug products, the FDA is potentially signaling to the consumer-facing CBD industry how the industry should be calculating percentage THC throughout the product formulation process.

While testing of botanical raw material is guided by the USDA Interim Final Rule on Hemp Production,⁷ the FDA warns that manufacturing processes may generate intermediaries or accumulated by-products that exceed the .3% THC threshold and may be considered by the DEA to be Schedule I controlled substances. This could be the case even if the raw material and finished product do not exceed .3% THC. The FDA’s guidance may eventually become the standard applied to regulated CBD products in a form other than as a drug. However, through its guidance, the FDA is warning the CBD industry that the DEA may also have a significant and potentially destructive role to play in the manufacturing process for CBD products.

FDA Submits CBD Enforcement Policy Guidance to the White House

On July 22, 2020, the FDA submitted to the White House Office of Management and Budget a “Cannabidiol Enforcement Policy – Draft Guidance for Industry” for its review. The contents of the document are not known outside of the Executive Branch and there is no guarantee as to when, or even if, it will be released. Nevertheless, given the FDA’s interest in a legal pathway forward for CBD products, the submission is looked upon as a positive step forward. With this guidance, it is important to remember that the FDA’s primary concern is the safety of the consuming public and it continues to collect data on the effects of ingestible CBD on the human body.

It is doubtful that this guidance will place CBD products in the dietary supplement category given the legal constraints on the FDA and the lack of safety data available to the FDA. The guidance likely does not draw distinctions among products using CBD isolate (as found in Epidiolex), full or broad spectrum hemp extract, despite the FDA’s expressed interest in the differences between these compositions.⁸ Instead, the FDA is more likely to establish guardrails for CBD ingestible products without authorizing their marketing. These could include encouragement of Good Manufacturing Practices, accuracy in labeling, elimination of heavy metal and pesticide contamination, and more vigorous enforcement against marketing involving the making of disease claims. The FDA is not expected to prescribe dosage standards, but may suggest a maximum daily intake of CBD for individuals along the lines of the U.K.’s Food Standards Agency guideline of a maximum of 70 mg of CBD per day.⁹

Identifying concerns in the current marketplace; promoting accuracy in testing; highlighting the line between FDA regulation and DEA enforcement; and proposing guidance to the industry all appear to be signs of substantial progress on forging a regulatory path for ingestible CBD products.

The DEA’s Interim Final Rule Addressing Derivatives and Extracts Could Have a Devastating Impact on the Cannabinoid Industry

The seemingly benign Interim Final Rule published by the DEA in August with the stated intent of aligning DEA regulations with the changes to the CSA caused by the 2018 Farm Bill’s definition of hemp could cut the legs out from under the hemp-derived CBD industry.¹⁰ Claiming it has “no discretion with respect to these amendments,” the DEA rule states that “a cannabis derivative, extract, or product that exceeds the 0.3% delta-9 THC limit is a schedule I controlled substance, even if the plant from which it was derived contained 0.3% or less delta-9 THC on a dry weight basis.”¹¹ Under this interpretation of the 2018 Farm Bill language and the CSA, it is unclear whether processors of hemp for cannabinoid extraction would be in possession of a controlled substance if, at any time, a derivative or extract contains more than 0.3% delta-9 THC even though the derivative or extract may be in that state temporarily and/or eventually falls below the 0.3% threshold when included in the final product. It would not be unusual for extracts created in the extraction process to exceed 0.3% delta-9 THC in the course of processing cannabinoids from hemp.

The implications of the rule may have a chilling effect on those involved in, or providing services to, hemp processors. It is known, as revealed by the Secretary of the USDA to Congress, that the DEA does not look favorably on the legalization of hemp and development of the hemp industry. The DEA’s position is that the rule merely incorporates amendments to the CSA caused by the 2018 Farm Bill’s definition of hemp into DEA’s regulations. In doing so, the DEA made explicit its interpretation of the Farm Bill’s hemp provisions that it presumably has held since the language became operative. What is not known is whether this changes the DEA’s appetite for enforcing the law under its stated interpretation, which to date it has refrained from doing. Nevertheless, the industry is likely to respond in two ways. First, by submitting comments to the Interim Final Rule, which will be accepted for a 60-day period, beginning on August 21, 2020. Anyone concerned about the implications of this rule should submit comments by the deadline. Second, by the filing of a legal challenge to the rulemaking on grounds that the rule does not correctly reflect Congressional intent in legalizing hemp and, consequently, the rulemaking process violated the Administrative Procedure Act. If both fail to mitigate harm caused to the CBD industry, the industry will have to look to Congress for relief. In the meantime, if the hemp processing industry is disrupted by this rule, cannabis processors holding licenses in legal states may be looked upon to meet the supply needs of the CBD product manufacturers.

The Interim Final Rule also addresses synthetically derived tetrahydrocannabinols, finding them to be Schedule I controlled substances regardless of the delta-9 THC content. This part of the rule could impact the growing market for products containing delta-8 THC. While naturally occurring in hemp in small quantities, delta-8 THC is typically produced by chemically converting CBD, thereby likely making the resulting delta-8 THC to be considered synthetically derived.

The hemp-derived cannabinoid industry continues to suffer from a “one step forward, two steps back” syndrome. The USDA’s highly anticipated Interim Final Rule on hemp production (released Oct. 31, 2019) immediately caused consternation in the CBD industry, and continues to, due to certain restrictive provisions in the rule. Disapproval in the rule is evident by the number of states deciding to operate under their pilot programs for the 2020 growing season, rather than under the conditions of the Interim Final Rule.¹² With signs of real progress by the FDA on regulating the CBD products industry, yet another interim final rule could undercut the all-important processing portion of the cannabinoid supply chain by injecting the threat of criminality where there is no intent by processors to violate the law. It is not a stretch to suggest that both the USDA and FDA are being significantly influenced by the DEA. The DEA’s Interim Final Rule is just another troubling example of the legal-illegal dichotomy of cannabis that continues to plague the CBD industry.

References

U.S. Food & Drug Admin., Report to the U.S. House Committee on Appropriations and the U.S. Senate Committee on Appropriations, Sampling Study of the Current Cannabidiol Marketplace to Determine the Extent That Products are Mislabeled or Adulterated (July 2020).
U.S. Food & Drug Admin., Cannabis and Cannabis-Derived Compounds Quality Considerations for Clinical Research: Guidance for Industry(July 2020).
U.S. Food & Drug Admin., Cannabidiol Enforcement Policy: Draft Guidance for Industry (July 2020).
Implementation of the Agriculture Improvement Act of 2018, 85 FR 51639 (Aug. 21, 2020) (to be codified at 21 C.F.R. §§ 1308, 1312).
U.S. Food & Drug Admin., Collection and Analysis of Products Containing CBD and Cannabinoids, Notice ID RFQ_75F40120R00020 (Aug. 13, 2020).
Nat’l Inst. of Standards and Tech., NIST to Help Labs Achieve Accurate THC, CBD Measurements (July 21, 2020).
Agricultural Improvement Act of 2018, Pub. L. 115-334, title X, 10113 (codified at 7 U.S.C. §§ 1639o-1639s).
U.S. Food & Drug Admin., Report to the U.S. House Committee on Appropriations and the U.S. Senate Committee on Appropriations, Cannabidiol (CBD), p. 14 (March 2020).
U.K. Food Standards Agency, Food Standards Agency Sets Deadline for the CBD Industry and Provides Safety Advice to Consumers (Feb. 2020) at https://www.food.gov.uk/news-alerts/news/food-standards-agency-sets-deadline-for-the-cbd-industry-and-provides-safety-advice-to-consumers.
See supra n. 4.
Id.
U.S. Dept. of Agriculture, Status of State and Tribal Hemp Production Plans for USDA Approval (as of Aug. 26, 2020).