Tilray has managed to successfully import its first bulk supply of medical cannabis oil into the UK.
It was a Tilray product, in fact, that was not only confiscated at the border last year – but subsequently sparked media outrage over the denial of the same to one Billy Caldwell, an epileptic child. It was not the only outcry nor was Billy the only child endangered. And the British people, in fact, finally signalled that they had lost their stiff upper lip on this one last year.
All of this despite lingering and significant problems ever since. Not to mention an intriguing and well-timing market entry for Tilray right after things have been heating up on cannabis reform in Parliament of late.
The Tilray product, which will be imported from its new production facilities in Portugal, has already been distributed in other European countries, including Croatia and Germany.
What is significant in other words, is that the UK is starting to allow bulk orders in through customs- and they are coming not from Canada, but from Europe. Even if it is a Canadian company’s brand on the same, for now at least.
Tilray of course, is not the only company engaged in a race to get imports into the country. Right after Christmas last year, Canopy/Spektrum announced the same plans. Wayland has clearly been angling for a British outpost for some time. And of course, more locally initiated groups, including European Cannabis Holdings, have been working to initiate easier access to British markets for well over a year. Let alone more locally grown interests and pursuits now clearly lining up for market entry.
But this announcement, coming so shortly after all the recent activity on cannabis reform and calls for trials in the UK, clearly means that the doors are now opening fast for the largest players angling to get in.
Bottom line? Look for the biggest Canadians with an already established European presence, to begin making similar announcements this summer.
Being “Available” Is Only The First Hurdle
One of the biggest problems facing not only the “industry” but patients in the UK, much like elsewhere, is that doctors do not know or want to prescribe cannabis and cannabinoid medicines- and for reasons stemming from fear or ignorance about medical efficacy to insurance coverage.
Medical cannabis, in all its forms so far, however, is also highly expensive and out of reach for most unless they obtain an NHS approval (or as in Germany, statutory health insurer approval) to actually obtain the drug. And then have a place to obtain it.
This basically counts out everyone who cannot pay out of pocket and cannot find a willing doctor to sign them up via onerous and ongoing paperwork. And that, of course, is the majority of the sick people in the room.
It is this basic conundrum, which the bigger Canadians have yet to solve themselves (and it is becoming more of a recognized issue in the U.S. in the days, presumably, before the 2020 election which will hopefully set a timetable for federal reform) that has been in the room for the last two years thanks to Germany.
Image credit: Flickr
It is even more of an issue in the UK. Especially with a renegotiation in Britain’s diplomatic and trade relationship with the rest of the world.
That includes, as of mid-July, a downright, undiplomatic spat between the White House and Whitehall right now over leaked comments from the British Ambassador to Washington – and about matters of competency far from cannabis. Although of course, this issue is in the room.
For that reason, the Canadian as well as the European connection to imports right now (from not just Portugal but Holland) on the medical side of the ledger, spell an intriguing fall for not only cannabis, but the real shape and direction of British politics- and by extension- British trade.
Patients Are Taking It To The Streets And To Parliament
As much as patients have so far partnered with the big Canadian companies in the attempt to get the borders open, this is not the only game in town. Dutch imports, from Dutch companies, are already showing up in the UK (see Bedrocan). And both British and Irish growers are getting in on early action, even if for now “just” on the CBD side.
Furthermore, it is clear that patients are playing a large role in making sure that they are being heard, even to the point of putting pressure on doctors. In an extraordinary admission at the parliamentary level during the last week of June, lawmakers conceded that the British public was taking matters into their own hands. And furthermore, that the change in the law had led to clear expectations that were not being met.
Namely, British patients are literally demanding medical cannabis by prescription from their doctors.
And much like in Germany, with a mandate for coverage, the government is being forced to listen, and as best as it can in a severely crimped and politicized Brexit environment, respond.
While cannabis reform is hardly the Guy Fawkes, in other words, in a tinder match environment that British politics certainly is right now, it might be a kind of spark that drives a much wider conversation in the UK about current events.
Specifically the survival of a system that is poised to provide not only access to cannabis but comprehensive medical care beyond that, even for the old or chronically ill.
For all of today’s growing acceptance and legitimacy with cannabis, the reality is that today’s operators – whether growers/producers or dispensary operators – still face risks in running their businesses. If, in the old days, a customer got deathly ill from cannabis contaminated with something from somewhere during the distribution chain, oh, well. But now that there’s a legal system of checks and balances; there’s recourse when issues arise.
The problem is that the business is so new that most people don’t know what they don’t know about mitigating those risks. And that, unfortunately, extends to many in the insurance business who need to be doing a better job helping put the right protections in place.
One grower bemoaned to me at a cannabis trade show, “I sure wish I could insure my crops.” What? “You can,” I told him. His old-school ag broker didn’t know any better and didn’t do him any favors with his ignorance. But it brought home the point: We have to start treating cannabis like the real business it is.
Reviewing the existing insurance policies of today’s cannabis businesses uncovers some serious gaps in coverage that could be financially crippling if not downright dangerous should a claim be triggered. Retail dispensaries, for example, are high-cash businesses, making banking and trusted employees a must-have.Today’s cannabis businesses need to understand there will be risks but they are a lot more manageable than in the old days.
And a close eye must be cast to lease agreements for hidden exposures, too. We know a Washington state grower that had no property insurance on its large, leased indoor growing facility. The company’s lease made its owners, not their landlord, responsible for any required building improvements. It was one of a variety of serious exposures that had to be fixed.
Today’s cannabis businesses need to understand there will be risks but they are a lot more manageable than in the old days. Rather than find themselves under-insured, they can start by learning what they probably have wrong about insurance. Dispelling three of the most common myths is a good place to start.
Myth #1: Nobody will insure a cannabis business.
Not remotely true. You can and should get coverage. Think property and casualty, product liability, EPLI and directors and officers, employee benefits and workers comp. Additionally, you should be educated on what crop coverage does and doesn’t cover. Depending on your business’ role in production and distribution, you might also consider cargo, stock throughput, auto, as noted, crime and cyber coverage. It pays to protect yourself.
Myth #2: If my business isn’t doing edibles, I don’t have to worry about product liability insurance.
The reality is that product liability may be the biggest risk the cannabis industry faces, at every level on the supply chain. There’s a liability “trickle down” effect that starts with production and distribution and sales and goes down to labeling and even how the product is branded. Especially when a product is an edible, inhalable or ingestible with many people behind it, the contractual risk transfer of product liability is an important consideration. That means the liability is pushed to all those who play any role in the supply chain, whether as a producer or a retailer or an extractor. And all your vendors must show their certificates of insurance and adequate coverage amounts. Don’t make the mistake of being so excited about this new product that you don’t check out the vendors you partner with for this protection.
Myth #3: Any loss at my operation will be covered by my landlord’s policy.
As the example I cited early illustrated, that’s unlikely. Moreover, your loss might even cause your landlord’s insurance to be nullified for having rented to a cannabis business. It’s another reason to examine your lease agreement very carefully. You want to comply with your landlord’s requirements. But you also need to be aware of any potential liabilities that may or may not be covered. Incidentally, even if your landlord’s policy offers you some protection, your interests are going to be best served through a separate, stand-alone policy for overall coverage.
These are interesting times for the burgeoning legal cannabis business. Getting smart – fast – about the risks and how to manage them will be important as the industry grows into its potential.
Did you know that the use of personal vehicles for transporting cannabis products is one of the most frequent claims in the cannabis industry? It surpasses property, product liability and even theft. Businesses are either unaware of the risks involved in using personal vehicles for transporting cannabis, or they aren’t taking them seriously enough.
Considering the strict statutes many states have placed on transporting cannabis should be reason alone to be more diligent. For example, the California Bureau of Cannabis Control’s proposed regulations require cannabis business owners to ensure their drivers have designated permits to transport the product. The state’s current legislation mandates inspections at any licensed premises, and requires employers to provide detailed tracking and schedules on the transport of product. Further, the state prohibits using minors to transport cannabis, and considers it a felony to do so.
Regulatory concerns, combined with the potential liabilities that could come from driver behavior, are keeping insurers from offering auto coverage to the cannabis industry. In fact, just four insurers currently offer the industry auto coverage, with premiums running as high as $17,000 per auto on average. It is important to note that personal auto insurance falls short because it doesn’t cover cargo loss.
Alternatively, because the stakes are so high, many companies are using courier services to transport cannabis product. But cargo insurance is still an issue. Without it, the care, custody and control of someone else’s products, and insurance limits are lacking. Even when the courier has cargo coverage, because they are delivering for multiple companies, the claims payout would have to be split amongst all the customers – likely below the value of your loss.
Consider the following best practices when transporting cannabis:
Conduct background checks/review DMV records. Uncovering any potential driver issues prior to hiring is critical. Look for previous DUIs or drug related history. Employees who might use product before getting behind the wheel are a significant danger to other drivers and a major liability to the employer. Even after hiring, be on alert for signs that indicate poor driving performance. Use check-in/check-out processes for all drivers, and conduct regular vehicle walk-arounds to look for scratches, dents or other damage that otherwise might be unreported to the employer.First, and most importantly, assess your risk mitigation options. Then, put processes in place as soon as possible to eliminate risk.
Implement quarterly driver training. Educate employees on proper procedures. While minor fender benders and sideswipe accidents are most common, even these can be costly if not handled properly. Once law enforcement get involved in an accident the car’s transportation of cannabis could become a secondary issue. Teach drivers how to handle accidents while on the scene, including informing law enforcement about the cargo and the employer.
Use unmarked vehicles. Drivers carrying a significant amount of product and/or cash are tempting targets for thieves. Company cars used for transporting product should be newer, and have no fleet serial numbers or anything identifying the company.
Require increased personal liability limits. If an employee is using their own personal vehicle for business purposes, the business owner should require that person carry more than minimum limits of personal liability. Ideally, they should have $300,000 or more, at an absolute minimum $100,000.
Get started now
First, and most importantly, assess your risk mitigation options. Then, put processes in place as soon as possible to eliminate risk. Secure the right insurance coverage, and ask your broker/underwriter to provide any additional recommendations to best mitigate your transportation, delivery, and cargo exposures.
The British have finally decided that cannabis reform is overdue. In London at least, 63% of the population believe that recreational reform is a good idea. According to a poll by The Evening Standard, the rest of England too, is getting close to a majority when the idea of recreational reform is in the room.
It is, as usual, recreational reform that is the icing on a medical cake that has yet to be baked. But that spice brownie is well on its way to the oven too. According to the British Medical Journal as of the beginning of July, the idea of broader access to regulated medical supplies for patients is mandatory.
And in the ranks of the conservative party, Crispin Blunt founded the Conservative Drug Policy Reform Group last September to lead Parliament in a long overdue discussion about the use of both medicinal and recreational cannabis use in the UK that formally “launched” during the last week of June.
But how the industry will develop here is also a big question in the room right now, especially with a country poised on the edge of one of the biggest constitutional questions in the country’s history – to Brexit or not, and how.
Justice Minister Crispin Blunt (right) Photo courtesy of The UK Ministry of Justice, Flickr
The North American Influence Is Controversial
While Blunt, for example, sees no issue with injecting North American capital into the debate, there are others who are not so sanguine. And while the idea of Canadian reform is popular here, including the freedom of patients (and others) to grow small amounts themselves, the idea of Canadian companies influencing national policy is not. From The Daily Mail to The Guardian, there have been front page headlines about the coming financial influence of “The North Americans.”
That this discussion is also going on at a time when the UK is considering a completely new trade agreement with the world, including on pharmaceuticals, is not insignificant. Where the country’s drugs come from, far from cannabis, is absolutely on the table. Not to mention how much they cost.
Questions of basic access are likely, in other words, to be in the room for a long time here. The barriers to obtaining and filling a prescription start at its expense – which is ₤1,100 (about $1,400) per prescription. There are few people, let alone those who are chronically ill, who can afford the same. This is far from a “normalized” drug- even of last resort- at the NHS.So far, the number of actual cannabis patients in the UK (ones who go to a doctor for a prescription and fill it) is still under 100 people.
That said, it is a start. And for the first time, as of this summer, those with the money can in fact, obtain cannabis by prescription.
But what happens to those (the vast majority) who cannot?
Patients Are Feeling Side-lined
Just as in national legalizing conversations in the United States and Canada so far, patients are being pushed aside for “the business” to take the conversation forward. But where does this business fall on matters of price and access?
So far, the number of actual cannabis patients in the UK (ones who go to a doctor for a prescription and fill it) is still under 100 people.
While patient groups are organizing, and the earliest ones to gain national attention, usually families whose children have been directly in the line of fire, are getting commercial ambitions themselves, the fact remains that patient voices are not the loudest ones in the room. Although as Blunt announced last week, he does not see recreational reform happening in the UK for the next five years.
That also means that every Canadian company entering the market (in particular) will have to continue to sing the same medical song they have been humming across Europe- at least in public.
The UK is NOT Germany – But It’s Not Canada Or The US Either…
No matter how much more “liberal” supposedly, the English people are on the whole CBD question (there is already far more CBD for sale in the UK than just about anywhere else), the UK market is still far behind Germany. Why? Since March 2017, insurance companies auf Deutschland have been required to cover the drug – from sprays and pills to floss when prescribed by a doctor.
There are, by latest calculations about 50,000 German patients.
That said, it is clear that the British do not seem to give a fig about the entire “novel food” discussion and are literally, in some cases, daring the police to raid stores and shut down establishments. The idea of rebellion against EU rules seems very obvious on the CBD front.
Beyond this, however, it is also clear that “Canadian” much less “American” cannabis reform is not necessarily the only model in town.
As the British, in other words, do finally embrace the cannabis question, it is very likely that the face of the same will be of a unique Limey strain all of its own.
In the burgeoning cannabis market, grow facilities are facing more and more competition every day. New indoor cultivation enterprises are often being set up in formerly vacant industrial buildings and commercial spaces, while in other cases, companies are planning and constructing new grow facilities from the ground up. For all these establishments, continually lowering production costs while supplying the highest possible quality in ever-increasing yields is the way forward.
Whether in existing or new structures, concrete floors are ubiquitous throughout the majority of cannabis growing facilities. With the right treatment, these indoor concrete traffic surfaces can greatly contribute to a company achieving its operational objectives. Alternatively, insufficiently protected concrete floors can create annoying and costly barriers to accomplishing company goals.
Challenges in Cannabis Grow Facility Construction
As with any emergent industry, mainstream acceptance and market growth is bringing regulation to cannabis cultivation. Local governments are paying more attention to how cannabis growing facilities are constructed and operated. In addition to the standard business matters of building safety, employee working conditions and tax contributions, elected officials are increasingly under pressure from constituents to analyze the overall effect of grow facilities on their communities at large.
High consumption of energy for grow room lights and high water usage are just part of the equation. The temperature and humidity needs of a grow facility can be similar to that of an indoor swimming pool environment. While warmth and moisture are ideal for cannabis growth, they also provide the ideal conditions for the growth and proliferation of fungi and other undesirable microorganisms. Therefore, to help preserve plant health in the moist indoor climate, fumigation often comes into play.
Carbon dioxide (CO2) enrichment of grow room air, a common practice proven to increase crop yields, presents another set of safety and health considerations in dense urban environments.
Adding to these challenges, many cannabis grow facilities are producing plants destined for either pharmacological or nutritional use. This in itself demands scrutiny by regulators for the sake of the consuming public.
As a result, grow room managers and owners must stay informed about the evolution of the industry in terms of local and federal agency regulations concerning their facilities, their overall operation and their products.
Bare Concrete Floors in Grow Rooms
As a foundational construction material, concrete continues to lead the way in commercial and industrial construction. Despite the many advantages of concrete floors, when left unprotected they can present significant challenges specific to cannabis grow rooms.
Untreated, bare concrete is naturally porous, easily absorbing liquids and environmental moisture. Substances found in grow rooms, such as fertilizers, fungicides and other chemicals, can leach through the porous concrete floor slab into the soil and ground water. Whether organic or synthetic, concentrations of such substances can be highly detrimental to the surrounding environment.
Whether in an existing or newly constructed facility, it is not uncommon for the under-slab vapor barrier to be compromised during construction. When this occurs, moisture from the soil beneath the floor slab can enter the concrete and move osmotically upward, creating a phenomenon known as Moisture Vapor Transmission (MVT). The resulting moisture and moisture vapor tends to become ever more alkaline as it rises upward through the concrete slab. MVT can result in blistering, bubbles and other damage to floor coverings.
The warm temperatures, regular watering of plants and high relative humidity maintained within many grow rooms can contribute to a weakening of the structural integrity of unprotected grow room slabs.
Within the confined space of a grow room, the warm, moist air invites microbe proliferation. Food and pharmaceutical plants are high on the priority list when it comes to facility hygiene levels, as demanded by code.
Public health guidelines for cannabis cultivation facilities in various parts of the country are increasingly mirroring those of food processing. Typical requirements include having smooth, durable, non-absorbent floor surfaces that are easily cleaned and in good repair, possessing proper floor slope towards a sanitary floor drain, with no puddling, as well as an integral floor-to-wall cove base. These directives cannot be met with bare concrete alone.
Optimal Grow Room Flooring Performance
In some locations, cannabis growing facilities are already subject to strict building codes and regulations. This will no doubt be spreading to other regions in the near future. For example, the Public Health Agency of Los Angeles County publishes construction guidelines to ensure cannabis facility floors meet standards mirroring the food processing and pharmaceutical manufacturing industries, where sanitation, facility hygiene and safety are paramount. In these types of facilities, bare, unprotected concrete floor slabs are not allowed as a general rule, due to the material’s innate porosity and absorbency.
Flooring in grow rooms, like in their food and pharma industry counterparts, should optimally:
Provide a monolithic and virtually seamless surface to help eliminate crevices, grout lines and other dark, damp locations where soil and pathogens tend to hide
Be impervious and non-porous, providing a surface that can isolate toxic materials on the surface for proper clean-up where needed
Enable correction or improvement of the floor slope for proper drainage, with no low spots to help avoid puddling
Be installed with integral floor-to-wall cove options for easier wash-down and sanitizing
Have the strength and thermal shock resistance, plus the tenacious bond, to undergo steam-cleaning and/or hot power washing, where needed
Enable seamless, continuous surface installation over concrete curbs and containment areas
Offer antimicrobial options for highly sensitive locations
Demonstrate high compressive strength and impact resistance for durability under heavy loads
Display excellent abrasion resistance, allowing the system to perform under grueling daily wear-and-tear
Present customizable slip-resistance options that can be balanced with easy clean-ability
Facilitate the use of floor safety markings, such as color-coded traffic and work area designations
Be formulated with low odor, low-VOC chemistries that meet all EPA and similar regulations
Be able to contribute LEED Green Building Credits, where desired
Include options for refurbishing old or damaged concrete surfaces to allow reuse of existing facility resources, as opposed to having to be demolished, thus unnecessarily contributing to landfill waste
Withstand and perform in continually damp grow room conditions, without degrading
Be compliant with FDA, USDA, EPA, ADA, OSHA, as well as local regulations and/or guidelines
Include MVT mitigating solutions where Moisture Vapor Transmission site issues are present
Provide waterproofing underlayment options for multi-story facilities
Demonstrate excellent resistance to a broad range of chemicals, fertilizers and extreme pH substances
Finding an affordable floor system with all the above features may seem like a tall order. Luckily, innovative manufacturers now offer cannabis facility flooring that meets sanitation, regulatory compliancy, durability and budgetary needs of growers.
Resinous Flooring Value for Cannabis Facilities
Choosing the right floor solutions for a given cultivation facility may be one of the most important decisions an owner or manager makes. Since floors are present throughout the structure, poor selection and compromised protection of concrete slabs can end up wreaking havoc with profits and yields over time.
Few facilities can afford the inconvenience and expense of an otherwise unnecessary floor repair or replacement. Having to suddenly move cumbersome plant beds and heavy pots in order to give workers access to the floor area can be headache. In addition, the unscheduled downtime and overall juggling of resources that invariably must take place make a strong case for investing in optimal grow room flooring from the start.
An excellent long-term value, professional-grade resinous floor systems present cannabis growers with a unique set of solutions for cultivation rooms. Not only does this type of flooring offer all the desirable features listed above, but also furnish a host of added benefits to grow room operations, including:
Very High Gloss Finish
Highly reflective floor surfaces enable light entering the space from overhead to bounce back upward, exposing the underside of leaves to the light and potentially increasing yields
Exceptionally high gloss floor finishes in light colors help make the most of your existing lighting sources, significantly increasing room illumination
Achieving greater illumination without adding fixtures helps reduce energy consumption and associated costs
Virtually Seamless Surface
Fluid-applied resin-based flooring provides an impermeable, monolithic surface that is exceptionally easy to clean and maintain
The virtually seamless finish of resinous coated floors greatly reduces the number of locations for soil, pathogens and microbes to gather
Resinous floors, by incorporating integral cove bases to eliminate ninety degree angles, correcting floor slope to eliminate puddling, and allowing for a virtually seamless surface, provide an optimally sanitary flooring solution
Outstanding Moisture Tolerance
Designed specifically for use in wet industrial environments, cementitious urethane flooring is a top choice for humid grow rooms
Also called “urethane mortar”, this type of floor can help mitigate certain undesirable site conditions, such as Moisture Vapor Transmission (MVT)
Chemical, Acid and Alkali Resistance
Whether organic or synthetic, many soil enhancers and substances used to eradicate undesirable fungi and pests can damage concrete and shorten the usable life of foundational slabs
Protecting concrete slabs with monolithic, non-absorbent and appropriately chemical resistant coating systems allows concrete to perform as designed, for as long as intended
A proper barrier coating on the floor allows spilled or sprayed substances to be properly cleaned up and disposed of, rather than allowing the liquids to seep through the porous slab, and into the surrounding natural environment
Added Safety
Resinous coating systems’ slip-resistance is completely customizable at the time of installation, enabling growers to request more traction in pedestrian walkways and less slip-resistance under raised beds.
Epoxy, urethane and polyaspartic resinous flooring systems accommodate the installation of safety and line markings, as well as varying colors to delineate specific work areas
The antimicrobial flooring options available from some manufacturers offer further hygiene support in highly sensitive facilities
Today’s industrial resinous floor coatings from reputable suppliers are very low to zero V.O.C. and compliant with EPA and other environmental regulations
Resinous coating systems provide ideal value to informed growers who require durable, reliable and long-lasting high performance flooring for their facilities.
Support from the Ground Up
From incredible medical advances to high tensile fiber in construction materials, the expanding cannabis industry is bringing exciting opportunities to many areas of the economy. As more and more growers enter the market, so increases the pressure to compete.
By choosing light reflective, seamless and moisture tolerant resinous flooring that meets regulatory guidelines for grow rooms, managers can help reduce their overhead costs on multiple fronts — and get a jump on the competition.
With recent changes in federal and state law, and growing consumer awareness, the long-dormant hemp industry may finally be able to take heed of George Washington’s advice, “Make the most you can of [India Hemp] … The Hemp may be sown anywhere.”1
Hemp has a long and varied history in the United States. Throughout his lifetime, George Washington cultivated hemp at his Mount Vernon Estate, and, for a time, Washington even considered replacing tobacco with hemp as the Estate’s primary cash crop.2 Like Washington, Thomas Jefferson grew hemp at Monticello and his lesser-known Poplar Forest plantation.3 Both Founding Fathers primarily used the hemp cultivated on their property for making household items like clothing, rope, and fishing nets.
From the colonial era until 1970, hemp was routinely cultivated across the United States for industrial use. But, with the passage of the Controlled Substances Act (“CSA”) in 1970, U.S. hemp production ceased.4 The CSA banned cannabis of any kind, eliminating any distinction between hemp and other types of cannabis. As a result, hemp production became illegal in the United States.
A wide variety of hemp products can be found throughout the Untied States markets. Image courtesy of Direct Cannabis Network
More recently, the U.S. government finally began to ease restrictions on hemp cultivation and production. The 2014 Farm Bill introduced the USDA Hemp Production Program.5 Under the Program, universities and state departments of agriculture are allowed to cultivate hemp if:
The industrial hemp is grown or cultivated for purposes of research conducted under an agricultural pilot program or other agricultural or academic research; and
The growing or cultivating of industrial hemp is allowed under the laws of the state in which such institution of higher education or state department of agriculture is located and such research occurs.
The 2014 Farm Bill did not remove hemp from the auspices of the CSA, nor did it address the continuing application of federal drug control statutes to the growth, cultivation, manufacture, and distribution of hemp products.
The 2018 Farm Bill built upon the deregulation that began in 2014.6 Although both the 2014 and 2018 bills define hemp as the plant Cannabis sativa L. and any part of that plant that has a delta-9 THC concentration of 0.3% or less by dry weight,7 the 2018 Farm Bill took the additional step of removing hemp from the federal list of controlled substances and categorized it as an agricultural product. As a result, the production of hemp is now subject to USDA licensure and regulation. However, until the USDA completes its rulemaking process for implementing hemp regulation, hemp production remains illegal unless done in compliance with the terms of the earlier 2014 bill.8 For the time being, legal cultivation of hemp still must occur in a state that has authorized hemp research9 and the researcher must be either an institute of higher education or a state department of agriculture (or its designee).
With the increasingly favorable changes to federal and state law allowing for the expanded cultivation and production of hemp in the United States, the market is expected to grow significantly in the coming years. In 2014, the U.S. industrial hemp market was estimated at approximately $504 million.10 In only one year after the passage of the 2014 Farm Bill, the industrial hemp market was estimated to have increased by over $95 million to almost $600 million. By 2017, the worldwide market for industrial hemp was estimated to be $3.9 billion and growing at a compound annual growth rate (CAGR) of 14%.
In addition to favorable changes in U.S. law, the hemp market is benefiting from growing consumer awareness and demand for hemp-based food products.11 High in omega-3 and omega-6, amino acids and protein, hemp is growing in popularity as a cooking oil, dairy substitute, flour source and bakery ingredient. Among other things, hemp is considered by some to provide positive health effects for those seeking help with insulin balance, cardiac function, mood stability, and skin and joint health.
Although hemp cultivation is now allowed in the U.S.—at least for research purposes—and the market is forecasted to rise steadily under growing demand for hemp-based products, broad access to viable, legal seeds continues to present a challenge for researchers and commercial growers. In order to legally implement authorized cultivation programs and take economic advantage of a swiftly growing market, farmers must have access to seeds that can be guaranteed to consistently produce plants that fall under the legal definition of hemp. In an attempt to alleviate the problem, several states, including California, Indiana, Maine and Oregon, have implemented programs to license or certify compliant seed distributors and producers.
The importance of hemp seed availability and development has also been recognized on the federal level. On April 24, 2019, the USDA Agricultural Marketing Service published a Notice to Trade announcing that the USDA’s Plant Variety Protection Office (“PVPO”) is now accepting applications of seed-propagated hemp for protection under the Plant Variety Protection Act (“PVPA”). Among other things, the PVPA provides intellectual property protection to breeders who have developed new varieties of seed-propagated plants. Under the new guidance, breeders of new hemp varieties can now secure protection pursuant to the PVPA. Those holding a certificate of protection from the PVPO can exclude others from marketing or selling a registered hemp variety and manage how other breeders and growers use their protected variety.
The process for requesting protection under the PVPA is fairly straightforward. Breeders, or their attorneys, must complete all application forms, pay the required fees,12 submit a distinct plant variety name, and provide a deposit of at least 3,000 viable and untreated seeds of the variety (or 3,000 seeds of each parent variety for a hybrid). One required form for a completed PVPA application is the Objective Description of Variety form.13 This form provides a series of questions that identify the distinct aspects of the variety in question, including, among other things, plant and leaf characteristics, seed properties and anticipated uses. Upon receipt of the completed application and fees, the PVPO examines the application to determine whether the listed plant variety is new, distinct, uniform, and stable. If the PVPO determines that the requirements are satisfied, it will issue a certificate of protection granting the owner exclusive rights to the registered variety for a period of 20 years.Now is the time for farmers, researchers, and hobbyists alike to take advantage of the expanded opportunities available for protecting intellectual property for proprietary hemp varieties.
Although hemp has traditionally been used in the textile and fiber industries, the estimated 17.1% CAGR in the hemp seed segment is being driven by the increase in demand for hemp oil, seedcakes, and other food and nutraceutical products. These products are primarily derived from the hemp seed as opposed to its fibers. Presently, hemp seeds contain approximately 30-35% oil, of which approximately 80% is essential fatty acids, and 25% crude protein.14 Under the new PVPA guidelines, if a breeder is able to cultivate a sustainable plant that increases the plant’s production of the desirable compounds, he or she could achieve a significant position in the growing market.
The protection provided by the newly expanded PVPA builds upon other avenues of intellectual property protection now available to hemp breeders and growers. In addition to the PVPA, plants meeting certain criteria may also be protectable under a plant patent or a utility patent, both of which are administered by the U.S. Patent and Trademark office. Generally speaking, PVPA protection may be available for seeds and tubers, plant patent protection applies to asexually propagated plants, and utility patent protection may be available for genes, traits, methods, plant parts and varieties.15
With a market that is expected to grow substantially in the near future, and with the passing of increasingly friendly federal and state legislation, the hemp industry is on the cusp of significant expansion. Now is the time for farmers, researchers, and hobbyists alike to take advantage of the expanded opportunities available for protecting intellectual property for proprietary hemp varieties.
George Washington to William Pearce, 24 February 1794.
To date, at least 41 states have passed legislation authorizing hemp cultivation and production programs consistent with federal law. As of the date of this article, those states that have not enacted legislation allowing the cultivation of hemp for commercial, research, or pilot purposes include: Connecticut, Georgia, Idaho, Iowa, Louisiana, Mississippi, Ohio, South Dakota, Texas, and the District of Columbia.
Currently, the Food and Drug Administration prohibits hemp-based CBD in food and beverages. However, the FDA has set a public hearing to discussing the legalization of CBD in food and beverages for May 31, 2019.
The PVPA application fee is currently $4,382 with an additional fee of $768 due upon issuance of a certificate of registration.
Hemp Seed (Cannabis sativa L.) Proteins: Composition, Structure, Enzymatic Modification, and Functional or Bioactive Properties,Sustainable Protein Sources (Ch. 7), R.E. Aluko (2017).
Regulations are currently under consideration that could expand or otherwise modify the scope of protection available under each of the enumerated intellectual property protection schemes. Consult a licensed attorney for questions regarding the specific program that may apply to a particular set of circumstances.
Core values often get wrapped into buzzwords such as sustainability, locally sourced and organic. In the first part of a series of four articles exploring greenhouses and the environment, we’re going to take a look at indoor vs. outdoor farming in terms of resource management.
Full disclosure; I love the fact that I can eat fresh blueberries in February when my bushes outside are just sticks. Is there a better way to do it than trucking the berries from the farm to a distribution plant to the airport, where they’re flown from the airport to a distribution center, to the grocery store and finally to my kitchen table? That’s a lot of trucking and a lot of energy being wasted for my $3.99 pint of blueberries.The largest generation in the history of the country is demanding more locally grown, sustainable and organic food.
If those same blueberries were grown at a local greenhouse then trucked from the greenhouse directly to the grocery store, that would save diesel fuel and a lot of carbon emissions. People who can only afford to live near a highway, a port or an airport don’t need to ask a pulmonary specialist why their family has a higher rate of COPD than a family who lives on a cul-de-sac in the suburbs.
Fact: 55% of vegetables in the U.S. are grown under cover. The same energy saving principles apply to indoor cannabis and the reasons are consumer driven and producer driven. The largest generation in the history of the country is demanding more locally grown, sustainable and organic food. They want it for themselves and they want it for their kids.
The rapid proliferation of greenhouses over the past ten years is no coincidence. Millennials are forcing changes: organic fruit and vegetables now account for almost 15% of the produce market. A CNN poll last month revealed that 8 of 10 of registered Democrats listed climate change as a “very important” priority for presidential candidates. The issue is not party I.D.; the issue is that a large chunk of Americans are saying they’re worried about the direct and indirect impacts of climate change, such as increased flooding and wildfires.
So how does the consumer side tie into the cannabis industry? Consumers like doing business with companies who share their values. The hard part is balancing consumer values with investor values, which is why many indoor growers are turning to cultivation management platforms to help them satisfy both constituencies. They get the efficiency and they get to show their customers that they are good stewards of their environment. The goal is to catch things before it’s too late to save the plants. If you do that, you save the labor it costs to fix the problem, the labor and the expense of throwing away plants and you reduce pesticide and chemical usage. When that happens, your greenhouse makes more money and shows your customers you care about their values.
The indoor change is happening rapidly because people realize that technology is driving increased revenue while core consumer values are demanding less water waste, fewer pesticides, herbicides and fertilizers.Let’s add some more facts to the indoor-outdoor argument. According to an NCBI study of lettuce growing, “hydroponic lettuce production had an estimated water demand of 20 liters/kg, while conventional lettuce production had an estimated water demand of 250 liters/kg.” Even if the ratio is only 10:1, that’s a huge impact on a precious resource.
Looking at the pesticide issue, people often forget about the direct impact on people who farm. “Rates in the agricultural industry are the highest of any industrial sector and pesticide-related skin conditions represent between 15 and 25% of pesticide illness reports,” a 2016 article in The Journal of Cogent Medicine states. Given the recent reports about the chemicals in Roundup, do we even need to continue the conversation and talk about the effects of fertilizer?
I’ll finish up with a quote from a former grower. “The estimates I saw were in the range of between 25%-40% of produce being lost with outdoor farming while most greenhouse growers operate with a 10% loss ratio.”
The indoor change is happening rapidly because people realize that technology is driving increased revenue while core consumer values are demanding less water waste, fewer pesticides, herbicides and fertilizers. Lastly, most Americans simply have a moral aversion to seeing farms throw away food when so many other people are lined up at food banks.
This summer, as new distributors continue to get into the cannabis game (in Germany, the UK and beyond), and at least two countries (Greece and Macedonia get GMP-certified), the battle is now on not just for cultivation and distribution licenses, but the end point of sale, pharmacies.
Pharmacies were always going to play a large role in cannabis distribution in Europe, starting with the fact that there will not be a separate “dispensary” system (as there is in the United States and Canada). Further, in some jurisdictions, notably Germany, the idea of the “apotheker” is one that is not going to go away anytime soon. No matter how intriguing the concept of online pharmacies actually are to everyone else (see the British).
Further, the shift to what is widely being referred to as “tele” or “digital” health is only going to increase in prevalence as discussions continue. Cost and access (to all medications, not just cannabis) are an issue near and dear to the average European. So is the right and consumer safety issues of being able to consult with a local pharmacist, who might even know you personally, and can advise on the health effects of the medicines they pass over the counter.
Photo: Ian McWilliams, Flickr
Jens Spahn, the current Health Minister of Germany, is touting a move to personal management of health records and digital prescriptions by next year. However, nobody knows exactly what that means, much less the functionality of the same.
Further, the German pharmacy situation in particular is one that has implications across Europe no matter how aggressively “digital health” solutions are implemented here. By law, no more than three (in some rare cases four) brick and mortar pharmacies can be owned by the same owner. There is no such thing as “Boots” (a British chain) or “Walgreens” (an American one).
Doc Morris, the Dutch online pharmacy, has always been an option for Germans just across the border. The problem of course is that insurers so far have been refusing to pay for critical parts of this idea. The company is currently experimenting with working with insurers- but do not expect the average chronically ill person in any country to suddenly get expedited access. So far, the only innovations in this market have hit as the privileges of the privately insured.
Second class status (and significantly lagging behind those with private healthcare) is also very much in the room as a political issue- and cannabis access has only sped this up.
If the scenario in the EU two years ago could be described as the race for import licenses and cultivation rights, this year, the focus of the big guys is very much trying to mainstream their product and get it on as many “shelves” as possible.
In Europe, however, since nobody can ship straight to the patient (as in Canada), the next most obvious step is securing access to pharmacies.
The Cannabis Industry Cometh
Even before Aphria announced its purchase of CC Pharma (one of Germany’s largest distributors) in a deal that finally closed in January of this year, the larger companies have been looking for a more efficient supply chain situation. Owning a distributor is certainly one way to go about this.
As of May 2019, Aleafia Health and its wholly owned subsidiary, Emblem, entered a JV with Acnos Pharma GmbH – with access and reach to 20,000 German pharmacies. And Wayland announced its merger with ICC, with pharmacies across the world.
As early as October 2017, Tilray and Cronos together tried to storm the German market (by inking a deal to reach the 20k plus pharmacies in the German system). Two years later, and this still has not made a huge difference in access.
Regardless of these larger industry players, however, or perhaps so far because of their statements and the resulting continued lack of access for most patients, it is also fact, particularly in both Germany and the UK, that merely having relationships with pharmacies is not enough. This year, there is also a fairly major price drop in the cards for the cannabis industry. And while the larger players may blanket the market with relationships, actually providing access to GMP-certified medical cannabis at a decent if not competitive price, is going to continue to have an impact on every market, particularly in those situations where compliant online access can be connected to indie distribution.
It is also an environment where the advantage still does not necessarily go to the “big guys” – a strategy that Wayland, for one, has been playing strategically for the better part of the last two years better than any other Canadian in the market. Especially when supply chain issues, beyond price, are still in the room.
Right now, pharmacies are well aware of their growing influence in this space in Europe. How much of an influence they will continue to have however, also rests on how effectively they preserve their right to have such an influence on the end consumer (as in Germany) or not (see the many discussions about this issue in the UK right now).
Further, as many of these entities are also realizing, and this is true far beyond the cannabis discussion, pharmacies are increasingly caught in the middle between consumer, doctor and insurer (this is certainly the case both for cannabis and also for all expensive orphan drugs).
How the pharmacies, in other words, begin to solve other issues, beyond just having a contractual relationship with a cannabis distributor/producer, is very much a part of the conversation right now. Access to cannabis via distribution deals with a Canadian or even Israeli partner certainly helps sales but it does not guarantee them.
One thing is for certain. The impact of new privacy legislation is having an effect, so even in an environment where a distributor/producer buys a pharmacy, what they can then do with customer information they also might have been interested in purchasing, is not only highly limiting, but in the future it may be the best approach to handling liability, and from multiple directions that includes everything to access to affordable, certified product to cyber security issues.
To reinforce the ideas in the article, Sanitation Starting Points: More Than Sweeping the Floors and Wiping Down the Table, the main goal of sanitation is to produce safe food and to keep consumers healthy and safe from foodborne illness. With the cannabis industry growing rapidly, cannabis reaches a larger, wider audience. This population includes consumers most vulnerable to foodborne illness such as people with immunocompromised systems, the elderly, the pregnant, or the young. These consumers, and all consumers, need and deserve safe cannabis products every experience.
Sanitation is not an innate characteristic; rather, sanitation is a trained skill. To carry out proper sanitation, training on proper sanitation practices needs to be provided. Every cannabis food manufacturing facility should require and value a written sanitation program. However, a written program naturally needs to be carried out by people. Hiring experienced experts may be one solution and developing non-specialists into an effective team is an alternative solution. Note that it takes every member of the team, even those without “sanitation” in their title, to carry out an effective sanitation program.
Sanitation is a part of the Food and Drug Administration’s Code of Federal Regulations on current Good Manufacturing Practices (GMPs) in manufacturing, packing or holding human food (21 CFR 110). Sanitation starts at the beginning of a food manufacturing process; even before we are ready to work, there are microorganisms, or microbes, present on the work surfaces. What are microbes? At a very basic level, the effects of microbes can be categorized into the good, the bad, and the ugly. The beneficial effects are when microbes are used to produce cheese, beer or yogurt. On the other hand, microbes can have undesirable effects that spoil food, altering the quality aspects such as taste or visual appeal. The last category are microbes that have consequences such as illness, organ failure and even death.In a food manufacturing facility, minimizing microbes at the beginning of the process increases the chance of producing safe food.
Proper sanitation training allows cannabis food manufacturing facilities to maintain a clean environment to prevent foodborne illness from affecting human health. Sanitation training can be as basic or as complex as the company and its processes; as such, sanitation training must evolve alongside the company’s growth. Here are five key talking points to cover in a basic sanitation training program for any facility.
Provide the “why” of sanitation. While Simon Sinek’s TEDx talk “Start with why” is geared more towards leadership, the essential message that “Whether individuals or organizations, we follow those who lead not because we have to, but because we want to.” Merely paying someone to complete a task will not always yield the same results as inspiring someone to care about their work. Providing examples of the importance of sanitation in keeping people healthy and safe will impart a deeper motivation for all to practice proper sanitation. An entertaining illustration for the “why” is to share that scientists at the University of Arizona found that cellphones can carry ten times more bacteria than toilet seats!
Define cleaning and sanitizing. Cleaning does not equal sanitizing. Cleaning merely removes visible soil from a surface while sanitizing reduces the number of microorganisms on the clean surface to safe levels. For an effective sanitation system, first clean then sanitize all utensils and food-contact surfaces of equipment before use (FDA Food Code 2017 4-7).
Explain from the ground up. Instead of jumping into the training of cleaning a specific piece of equipment, start training with the foundational aspects of food safety. For example, a basic instruction on microbiology and microorganisms will lay down the foundation for all future training. Understanding that FATTOM (the acronym for food, acidity, temperature, time, oxygen and moisture) are the variables that any microorganism needs to grow supplies people with the tools to understand how to prevent microorganisms from growing. Furthermore, explaining the basics such as the common foodborne illnesses can reinforce the “why” of sanitation.
PPE for all employees at every stage of processing is essential
Inform about the principles of chemistry and chemicals. A basic introduction to chemicals and the pH scale can go a long way in having the knowledge to prevent mixing incompatible chemicals, prevent damaging surfaces, or prevent hurting people. Additionally, proper concentration (i.e. dilution) is key in the effectiveness of the cleaning chemicals.
Ensure the training is relevant and applicable to your company. Direct proper sanitation practices with a strong master sanitation schedule and ensure accountability with daily, weekly, monthly and annual logs. Develop sanitation standard operating procedures (SSOPs), maintain safety data sheets (SDS’s) and dispense proper protective equipment (PPE).
Overall, sanitation is everyone’s job. All employees at all levels will benefit from learning about proper sanitation practices. As such, it is beneficial to incorporate sanitation practices into cannabis food manufacturing processes from the beginning. Protect your brand from product rework or recalls and, most importantly, protect your consumers from foodborne illness, by practicing proper sanitation.
As cannabis reform finally begins to hit the UK, the same confusion, lack of standards and uneven application of the “law” reigns supreme.
Just like other places (notably Israel, the United States and Canada), in the early days after medical reform hits, the English situation is instructive if not reminiscent of other fights elsewhere – no matter how much individual stories may differ on the surface. Just like in Israel for example, sick children had to be hospitalized before anyone moved forward on reform.
Just like in the United States, Canada and Israel, the people who were able to get into the changing industry first and early had money and political connections.
And just like everywhere else, who survives and who gets hit with red tape, is largely a matter not of entrepreneurial savvy, but connections, inherited privilege, race, gender and of course, bank account. In a place like the UK, where “class” is still a valid force on its own (beyond access to money), this is already obvious. As a theme, it is one that is sadly, not over yet for too many in or affected by “the industry.”
There are still, per the estimates available, less than 100 legal patients in the UK. Those served by the NHS are also well aware of their “second class” status when it comes to healthcare. This one issue, after all, drove Brexit, and may yet cause it to fail, just on this one issue. Cannabis may be a side note in the debate. But it is also, by this time, clearly in the room.
A Chelsea Popup Shop Survives While A Brighton Eatery Fails To Open
In January, two graduates of Imperial Business School (a private, prestigious university in London) opened a “pop up shop” (kind of like a kiosk) in Chelsea. This is a part of the city frequented by Royals on the hoof, reality stars of a certain vintage, and a lot of highly priced real estate.
So far, with the predictable fawning press coverage, the almost too “cutely” named TheDrug.Store (which by its own admission is selling non-medical products) has been doing brisk business.
Meanwhile, in the historic if less slightly less elite but almost as expensive touristy seaside town of Brighton, The Canna Kitchen, a CBD eatery with the catchy slogan of “let food be thy medicine”, was closed by the police right before it was supposed to open at the end of May (although there is no mention of this or the negative press on the website, which despite having no telephone number, still allows visitors to “book a table.”) The owners, who also seem to be quite well-heeled millennials themselves, appear to be on the verge of “losing hundreds of thousands of pounds and laying off 15 staff,” to quote The Guardian story on the subject.
Never mind the irony that they also seem rather well positioned financially. Or that many, many more people, usually called poor patients, are still at risk of being hospitalized because they cannot get (or afford) their medication.
As the industry, such as it is, and patient rights group organize in earnest this summer, reform in the UK also hinges on whether and what the country decides to do in the fall.
And despite the huge disparities that exist in terms of who has access (let alone to entrepreneurial capital), or perhaps because of them, look for a healthy debate from patients about policy, access and fairness.
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What is significant in other words, is that the UK is starting to allow bulk orders in through customs- and they are coming not from Canada, but from Europe. Even if it is a Canadian company’s brand on the same, for now at least.
