Tag Archives: growing

By Dr. Ginette M. Collazo

When we discuss growing and producing medical cannabis, we must think of it as a medicine. By definition, it is a substance intended to assist you with a medical condition, to help you feel better and not harm you. Drugs produced in the pharmaceutical industry go through extensive quality controls to ensure a level of safety for the consumer or patient. Yet when we talk process and quality controls in medical cannabis production, there is still a lot to learn.

Are we waiting for the wake-up call? Well, ring! Recently Health Canada, the regulatory body overseeing Canada’s medical cannabis market, decided that “It will begin random testing of medical marijuana products to check for the presence of banned pesticides after product recalls affecting nearly 25,000 customers led to reports of illnesses and the possibility of a class action lawsuit.”

Proper quality controls help protect businesses from unforeseen issues like those massive recalls in Canada. These can assure that the product is safe (won’t harm you), has integrity (free of contamination), and that the product is what it says it is (identity). To achieve this important goal, we must have robust systems that will guarantee product quality. Why is this important? Quality controls can ensure a safer and more consistent product, helping build patient and consumer trust and brand loyalty, preventing a public relations nightmare like a recall due to pesticide contamination.

Food processing and sanitation — Product recalls due to manufacturing errors in sanitation cause mistrust among consumers.

The FDA, among other regulatory bodies, has established excellent guidelines to implement these controls. So there is a lot we can learn from the pharmaceutical industry and that FDA guidance regarding quality controls and assurance. After all, we are all interested in the same thing: a safe and effective product.

So, let’s take a look at some of the controls included in the CFR (Code of Federal Regulation), Part 211 , which include Good Manufacturing Practices (GMPs) for finished products, and how you can implement them in the growing business of growing cannabis.

Personnel selection and training: The GMPs establish that “Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training… to enable that person to perform the assigned functions.” These include the creation of specific curricula per position and the establishment of requirements for specialized tasks. We all want to be successful so training, in this case, is what we call the vaccine for mistakes.
Facilities: “Any building or buildings used in the manufacture, processing, packing, or holding of a drug product shall be of suitable size, construction, and location to facilitate cleaning, maintenance, and proper operations.” This requirement includes segregation of spaces to avoid cross-contamination, housekeeping, the cleaning process and detergent types, material storage conditions, humidity levels, temperature, water, and even ventilation requirements to prevent contamination with microorganisms. All with the intention of protecting the product.
Pest control: “There shall be written procedures for the use of suitable rodenticides, insecticides, fungicides, fumigating agents, and cleaning and sanitizing agents. Such written procedures shall be designed to prevent the contamination of equipment, components, drug product containers, closures, packaging, labeling materials, or drug products and shall be followed.” There have been many issues pertaining this requirement. In 2010, Johnson & Johnson received many complaints claiming that the product had a musty, moldy odor. Later, the firm identified the cause of the odor to be a chemical, called 2, 4, 6-Tribromoanisole or TBA; a pesticide used to treat wooden pallets. One of the specific requirements of this section is to avoid the use of wooden pallets, but if you decide to use them, the method of sterilization by heat treatment seems like the only safe option for sterilizing wooden pallets and wood cases.
Equipment/Instrumentation: “Equipment used in the manufacture, processing, packing, or holding of a drug product shall be of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and its cleaning and maintenance.” The intention is to not alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements. What would happen if lubricants/coolants or any other substance, not intended to be part of the product, comes in contact with the product?
Procedures and documentation: “There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. Such procedures shall include all requirements of this subpart. These written procedures, including any changes, shall be drafted, reviewed, and approved. When we have followable, well written, clear, and specific procedures, we avoid possible errors that can get us in trouble.
Defects Investigation: “Written production and process control procedures shall be followed in the execution of the various production and process control functions and shall be documented at the time of performance. Any deviation from the written procedures shall be recorded and justified.” We want to be successful, for that we need to learn from failures, understanding the root causes, correcting and preventing re-occurrence is what will keep you competitive. As you can see this requirement is essential for, quality, business and to evidence that such deviations did not adulterate the product.
Process controls: Besides written procedures and deviations management, operation controls are pivotal in guaranteeing the quality as well as complete documentation of your process. These controls will vary depending on your technology and your product. If you do alcohol (ethanol) extraction, for example, you want to keep an eye on the temperature, dissolution time, and even have color standards to be able to quickly and correctly identify possible abnormalities, while you can still correct the mistake. In-process product testing will allow you to monitor “performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the final product.”

Regardless of federal regulatory guidance, quality controls can be that one factor which can make or break your business. Why re-invent the wheel?

May 10, 2017

Protecting Innovative Strains with a Strong Intellectual Property Strategy: Part 1– Why IP & Why now?

By Dr. Travis Bliss

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This three-part series will provide an in-depth look at intellectual property (IP) protection that is available for innovative and new varieties of cannabis. In this first installment, we will examine the reasons why cannabis breeders should adopt a strong IP strategy and look briefly at the types of IP that they should be considering. In the second and third pieces, we will look at the types of IP protection that can be used to protect innovative cannabis varieties and the unique IP issues the cannabis industry faces right now. Taken together, these articles will provide insight into IP strategies that cannabis breeders and growers can employ today to help prepare for the day that cannabis becomes legal nationally.

Why should I use IP to protect my cannabis varieties?

First and foremost, as the cannabis industry continues to move from a small, tight-knit community of breeders and growers into a ‘big-business’ industry, IP is the only way for breeders to protect the investment of time, energy and money that they put into developing new and innovative strains of cannabis. At a recent cannabis growing conference, one sentiment felt among numerous breeders was a feeling of frustration– stemming from the fact that they had spent many years developing new varieties of cannabis and, now that the industry is exploding, they are not getting recognition for all that effort. The way to avoid this issue is to protect novel varieties with IP to ensure that you are given proper credit for all of your hard work.

Moreover, an examination of industries that have strong similarities to the cannabis industry, such as other plant-based industries and ‘vice’ industries, provides compelling evidence that IP will become a main driving force in the cannabis industry as it continues to mature. For example, the fruit and hops industries have been relying upon strong plant patent and trademark protection for many years. The extremely popular Honeycrisp apple is a patented variety and the Amarillo hops variety (officially called ‘VGXP01’) is protected by both a U.S. Plant Patent and a federally registered trademark. Similarly, the alcohol and tobacco industries rely upon strong trademark and branding strategies, with many consumers being extremely brand-particular.

Additionally, there is strong evidence that the cannabis industry is primed for intellectual property protection. Since long before cannabis was legalized, consumers who were buying cannabis on the black market often sought out a particular variety from their dealer, something that becomes more prevalent as the industry continues to mature.

Why is now the time to think about IP?

First, the relevant governmental bodies have now provided some clarity as to the types of IP protection that can, and cannot be obtained for cannabis. For example, it is now clear that the U.S. Patent and Trademark Office (USPTO) will issue patents that cover new cannabis plant varieties and related innovations, such as novel growing methods. In fact, the first U.S. Plant Patent that covers a novel cannabis strain, called ‘Ecuadorian Sativa’, issued in late 2016.

Similarly, though federal trademark registration is not currently available if the product being protected is a cannabis product that is illegal under federal law. Federal trademark registration may be available to protect products related to the cannabis industry that are not themselves federally illegal (e.g., grow lights, fertilizer, etc.). Many states with legalized cannabis will grant state trademark registrations for cannabis products regardless of whether the products are viewed as illegal under current federal law. With this increased clarity, companies can now begin to formulate a comprehensive IP strategy that ties together the various types of IP protection.

Additionally, cannabis breeders and growers should look to adopt an IP strategy now because there are certain time bars that exist that may result in loss of rights if they wait. For example, as we will discuss in Part 2 of the series, patent protection can only be sought if the variety to be patented was not sold, offered for sale, or otherwise made publicly available more than one year before the patent application is filed. So if a breeder chooses to wait to seek patent protection for a new variety, the ability to ever get that protection may be lost.

The bottom line is that, to solidify their place in the market, cannabis breeders and growers should be formulating an IP strategy sooner rather than later. Those forward-thinking growers and breeders that adopt a comprehensive IP strategy up front will gain a distinct competitive advantage over competing growers and breeders down the road – an advantage that will become even more important if and when large corporations begin to move into the cannabis space. Those companies that have strong brands in place will be better equipped to survive and thrive in the face of pressure from legal teams at larger companies.

The next two installments of this series will examine the specifics of the types of IP protection that can be sought and the unique issues that the cannabis industry faces with each of them.

Legal disclaimer: The material provided in this article is for informational purposes only and not for the purpose of providing legal advice. The opinions expressed herein are the opinions of the individual author and may not reflect the opinions of the firm or any individual attorney. The provision of this information and your receipt and/or use of it (1) is not provided in the course of and does not create or constitute an attorney-client relationship, (2) is not intended as a solicitation, (3) is not intended to convey or constitute legal advice, and (4) is not a substitute for obtaining legal advice from a qualified attorney. You should not act upon any such information without first seeking qualified professional counsel on your specific matter.

April 19, 2017

Judging a Craft Cannabis Competition

By Aaron G. Biros

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Willamette Week, a Portland-based publication, is hosting the 2017 Cultivation Classic with Farma, Cascadia Labs, Phylos Bioscience and the Resource Innovation Institute on May 12^th. The event is a benefit for the Ethical Cannabis Alliance, an organization that promotes sustainability, labor standards and education surrounding the integrity and ethics of growing cannabis. Cultivation Classic is a competition for pesticide-free cannabis grown in Oregon, according to a press release.

Congressman Earl Blumenauer speaking at last year’s Cultivation Classic
Photo: Bridget Baker, 92bridges.com

While the event’s focus is on the competition, it is just as much a celebration of the craft cannabis community in Oregon. This year’s competition incorporates scientific collaboration like genetic sequencing for the winners by Phylos Bioscience and carbon accounting for all competitors. Keynote speakers include Ethan Russo, medical director of PHYTECS and Dr. Adie Po, co-founder of Habu Health. Congressman Earl Blumenauer, a prominent cannabis legalization advocate in Oregon, will also be speaking at the awards ceremony. You can check out the full schedule and speaker lineup here.

Raymond Bowser, breeder at Home Grown Natural Wonders, is a judge for this year’s Cultivation Classic. He speaks at cannabis conferences around the country and his business created a number of different strains, so he has experience with a myriad of growers and strains. “This time around everyone has really stepped up their game,” says Bowser. “The entries are noticeably better than last year.” When looking at the different samples sent to him, he sees a few key factors as most important in judging the quality. “What I am looking for is simple; a nice smell and a decent look, generally speaking,” says Bowser. “Aesthetics can tell you a lot about how it was grown, temperature changes and the overall care taken in cultivating and curing the flower.” For him, flavor, smell and aesthetics are the big variables to consider.

Those are factors that his company holds to high standards in their work, so he judges the samples based on the same variables. “It is what we strive for in our gardens and so far the samples I have tried are fantastic in that regard,” says Bowser. In other competitions that Bowser has judged in the past, they sent him between 40 and 60 strains to judge in seven days. “That is not conducive to a fair evaluation,” says Bowser. “Here, we are getting fourteen or so different strains, so we can sample one strain a day which is how I personally like to do it.”

Bowser is supportive of Cultivation Classic because of their emphasis on the craft industry. “We talk about craft cannabis and breeding craft cultivars at conferences around the country,” says Bowser. “With the rec industry growing so much, we see so many people cutting corners to save money, that it is refreshing to see growers take pride in the craft.” He also stresses the need for good lab testing and sound science in the trade. “I am big on lab testing; it is very important to get all the right analytics when creating strains,” says Bowser. “Cascadia is a solid choice for the competition; they have been a very good, consistent lab.” Emphasizing the local, sustainability-oriented culture surrounding the craft market, Bowser is pleased that this competition supports that same message. “We need to stay true to our Oregon roots and continue to be a clean, green, granola-eating state.”

Cascadia Labs is conducting the pesticide and cannabinoid analytics for all submissions and Phylos Bioscience will perform testing for the winners. According to Julie Austin, operations manager at Cascadia Labs, pesticide testing for the Oregon list of analytes was of course a requirement. “Some of the samples submitted had previous tests from us or from other accredited labs, but if they didn’t have those results we did offer a comprehensive pesticide test,” says Austin. The competition’s fee for submission includes the potency and terpenes analysis.

Jeremy Sackett, director of operations at Cascadia Labs, says they test for 11 cannabinoids and 21 terpenes. The samples are divided into groups of THC-dominant samples, CBD-dominant samples and samples with a 1:1 ratio of the two. “The actual potency data will be withheld from judges and competitors until the day of the event,” says Sackett. “We are data driven scientists, but this time we want to have a little fun and bring the heart of this competition back to the good old days: when quality cannabis was gauged by an experience of the senses, not the highest potency number.” The event will take place on May 12^th at Revolution Hall in Portland, Oregon. Click here to get tickets to the event.

April 13, 2017

Applications for Tissue Culture in Cannabis Growing: Part 1

By Aaron G. Biros

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Dr. Hope Jones, chief scientific officer of C4 Laboratories, believes there are a number of opportunities for cannabis growers to scale their cultivation up with micropropagation. In her presentation at the CannaGrow conference recently, Dr. Jones discussed the applications and advantages of tissue culture techniques in cannabis growing.

Dr. Hope Jones, chief scientific officer at C4 Labs

Dr. Jones’ work in large-scale plant production led her to the University of Arizona Controlled Environment Agriculture Center (CEAC) where she worked to propagate a particularly difficult plant to grow- a native orchid species- using tissue culture techniques. With that experience in tissue culture, hydroponics and controlled environments, she took a position at the Kennedy Space Center working for NASA where she developed technologies and protocols to grow crops for space missions. “I started with strawberry TC [tissue culture], because of the shelf life & weight compared with potted plants, plus you can’t really ‘water’ plants in space- at least not in the traditional way,” says Dr. Jones. “Strawberries pack a lot of antioxidants. Foods high in antioxidants, I argued, could boost internal protection of astronauts from high levels of cosmic radiation that they are exposed to in space.” That research led to a focus on cancer biology and a Ph.D. in molecular & cellular biology and plant sciences, culminating in her introduction to the cannabis industry and now with C4 Labs in Arizona.

Working with tissue culture since 2003, Dr. Jones is familiar with this technology that is fairly new to cannabis, but has been around for decades now and is widely used in the horticulture industry today. For example, Phytelligence is an agricultural biotechnology company using genetic analysis and tissue culture to help food crop growers increase speed to harvest, screen for diseases, store genetic material and secure intellectual property. “Big horticulture does this very well,” says Dr. Jones. “There are many companies generating millions of clones per year.” The Department of Plant Sciences Pomology Program at the Davis campus of the University of California uses tissue culture with the Foundation Plant Services (FPS) to eliminate viruses and pathogens, while breeding unique cultivars of strawberries.

A large tissue culture facility run in the Sacramento area that produces millions of nut and fruit trees clones a year.

First, let’s define some terms. Tissue culture is a propagation tool where the cultivator would grow tissue or cells outside of the plant itself, commonly referred to as micropropagation. “Micropropagation produces new plants via the cloning of plant tissue samples on a very small scale, and I mean very small,” says Dr. Jones. “While the tissue used in micropropagation is small, the scale of production can be huge.” Micropropagation allows a cultivator to grow a clone from just a leaf, bud, root segment or even just a few cells collected from a mother plant, according to Dr. Jones.

The science behind growing plants from just a few cells relies on a characteristic of plant cells called totipotency. “Totipotency refers to a cell’s ability to divide and differentiate, eventually regenerating a whole new organism,” says Dr. Jones. “Plant cells are unique in that fully differentiated, specialized cells can be induced to dedifferentiate, reverting back to a ‘stem cell’-like state, capable of developing into any cell type.”

Cannabis growers already utilize the properties of totipotency in cloning, according to Dr. Jones. “When cloning from a mother plant, stem cuttings are taken from the mother, dipped into rooting hormone and two to five days later healthy roots show up,” says Dr. Jones. “That stem tissue dedifferentiates and specializes into new root cells. In this case, we humans helped the process of totipotency and dedifferentiation along using a rooting hormone to ‘steer’ the type of growth needed.” Dr. Jones is helping cannabis growers use tissue culture as a new way to generate clones, instead of or in addition to using mother plants.

With cannabis micropropagation, the same principles still apply, just on a much smaller scale and with greater precision. “In this case, very small tissue samples (called explants) are sterilized and placed into specialized media vessels containing food, nutrients, and hormones,” says Dr. Jones. “Just like with cuttings, the hormones in the TC media induce specific types of growth over time, helping to steer explant growth to form all the organs necessary to regenerate a whole new plant.”

Having existed for decades, but still so new to cannabis, tissue culture is an effective propagation tool for advanced breeders or growers looking to scale up. In the next part of this series, we will discuss some of issues with mother plants and advantages of tissue culture to consider. In Part 2 we will delve into topics like sterility, genetic reboot, viral infection and pathogen protection.

March 29, 2017

Understanding Dissolved Oxygen in Cannabis Cultivation

By Aaron G. Biros

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Oxygen plays an integral role in plant photosynthesis, respiration and transpiration. Photosynthesis requires water from the roots making its way up the plant via capillary action, which is where oxygen’s job comes in. For both water and nutrient uptake, oxygen levels at the root tips and hairs is a controlling input. A plant converts sugar from photosynthesis to ATP in the respiration process, where oxygen is delivered from the root system to the leaf and plays a direct role in the process.

Charlie Hayes has a degree in biochemistry and spent the past 17 years researching and designing water treatment processes to improve plant health. Hayes is a biochemist and owner of Advanced Treatment Technologies, a water treatment solutions provider. In a presentation at the CannaGrow conference, Hayes discussed the various benefits of dissolved oxygen throughout the cultivation process. We sat down with Hayes to learn about the science behind improving cannabis plant production via dissolved oxygen.

In transpiration, water evaporates from a plant’s leaves via the stomata and creates a ‘transpirational pull,’ drawing water, oxygen and nutrients from the soil or other growing medium. That process helps cool the plant down, changes osmotic pressure in cells and enables a flow of water and nutrients up from the root system, according to Hayes.

Charlie Hayes, biochemist and owner of Advanced Treatment Technologies

Roots in an oxygen-rich environment can absorb nutrients more effectively. “The metabolic energy required for nutrient uptake come from root respiration using oxygen,” says Hayes. “Using high levels of oxygen can ensure more root mass, more fine root hairs and healthy root tips.” A majority of water in the plant is taken up by the fine root hairs and requires a lot of energy, and thus oxygen, to produce new cells.

So what happens if you don’t have enough oxygen in your root system? Hayes says that can reduce water and nutrient uptake, reduce root and overall plant growth, induce wilting (even outside of heat stress) in heat stress and reduce the overall photosynthesis and glucose transfer capabilities of the plant. Lower levels of dissolved oxygen also significantly reduce transpiration in the plant. Another effect that oxygen-deprived root systems can have is the production of ethylene, which can cause cells to collapse and make them more susceptible to disease. He says if you are having issues with unhealthy root systems, increasing the oxygen levels around the root system can improve root health. “Oxygen starved root tips can lead to a calcium shortage in the shoot,” says Hayes. “That calcium shortage is a common issue with a lack of oxygen, but in an oxygen-deprived environment, anaerobic organisms can attack the root system, which could present bigger problems.”

So how much dissolved oxygen do you need in the root system and how do you achieve that desired level? Hayes says the first step is getting a dissolved oxygen meter and probe to measure your baseline. The typical dissolved oxygen probe can detect from 20 up to 50 ppm and up to 500% saturation. That is a critical first step and tool in understanding dissolved oxygen in the root system. Another important tool to have is an oxidation-reduction potential meter (ORP meter), which indicates the level of residual oxidizer left in the water.

Their treatment system includes check valves that are OSHA and fire code-compliant.

Citing research and experience from his previous work, he says that health and production improvements in cannabis plateau at the 40-45 parts-per-million (ppm) of dissolved oxygen in the root zone. But to achieve those levels, growers need to start with an even higher level of dissolved oxygen in a treatment system to deliver that 40-45 ppm to the roots. “Let’s say for example with 3 ppm of oxygen in the root tissue and 6ppm of oxygen in the surrounding soil or growing medium, higher concentrations outside of the tissue would help drive absorption for the root system membrane,” says Hayes.

Reaching that 40-45 ppm range can be difficult however and there are a couple methods of delivering dissolved oxygen. The most typical method is aeration of water using bubbling or injecting air into the water. This method has some unexpected ramifications though. Oxygen is only one of many gasses in air and those other gasses can be much more soluble in water. Paying attention to Henry’s Law is important here. Henry’s Law essentially means that the solubility of gasses is controlled by temperature, pressure and concentration. For example, Hayes says carbon dioxide is up to twenty times more soluble than oxygen. That means the longer you aerate water, the higher concentration of carbon dioxide and lower concentration of oxygen over time.

Another popular method of oxidizing water is chemically. Some growers might use hydrogen peroxide to add dissolved oxygen to a water-based solution, but that can create a certain level of phytotoxicity that could be bad for root health.

Using ozone, Hayes says, is by far the most effective method of getting dissolved oxygen in water, (because it is 12 ½ times more soluble than oxygen). But just using an ozone generator will not effectively deliver dissolved oxygen at the target levels to the root system. In order to use ozone properly, you need a treatment system that can handle a high enough concentration of ozone, mix it properly and hold it in the solution, says Hayes. “Ozone is an inherently unstable molecule, with a half-life of 15 minutes and even down to 3-5 minutes, which is when it converts to dissolved oxygen,” says Hayes. Using a patented control vessel, Hayes can use a counter-current, counter-rotational liquid vortex to mix the solution under pressure after leaving a vacuum. Their system can produce two necessary tools for growers: highly ozonized water, which can be sent through the irrigation system to effectively destroy microorganisms and resident biofilms, and water with high levels of dissolved oxygen for use in the root system.

March 22, 2017

Preventing Yeast and Mold with Two-Way Humidity Control

By Aaron G. Biros

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When a grower harvests their cannabis plants, they process it by drying, curing and trimming the plant material. Dried cannabis ready for the consumer can often sit on retail shelves for months before it is purchased. According to the Cannabis Safety Institute, trimming is the processing stage with the highest level of human handling, and thus presents the most significant opportunities for microbiological contamination.

The Cannabis Safety Institute recommends workers handling dry cannabis wash their hands periodically, generally conform to food safety rules and wear gloves at all times. In addition to these tips, looking at relative humidity is a good tool to mitigate contamination concerns like the growth of yeast and mold spores. Mold spores can grow quickly when there is enough moisture, but if the cannabis is dry enough, mold spores cannot develop.

Growers controlling the relative humidity of their finished product in the past often placed an orange peel or a wet cotton ball in a jar with dried cannabis to retain the weight from water and keep it from over-drying. Those tactics have since been improved upon using modern technology.

Water activity is a measure of the relative humidity immediately adjacent to the product, according to Bob Esse, vice president of research at Boveda. “Cannabis’ relative humidity will reach equilibrium with the surrounding environment over time, which is why it is so critical to manage this adjacent atmosphere,” says Esse. “Moisture content is the total water present in the product and is a variable that changes in its relationship to water activity from one strain or type of product to the next.”

Back in 1997, Boveda first patented two-way humidity control. For the last 20 years, that company has made humidity control products for packaging in a variety of industries, like wooden musical instruments, pharmaceuticals, medical devices, electronics, tobacco, photos and documents and perhaps most notably for keeping cigars at the right humidity level in a humidor. According to Charles Rutherford, business development director at Boveda, he saw people buying their products meant for cigars, but using them with cannabis. About six years ago, they started developing a product specifically for the cannabis market.

The science behind it is relatively simple, says Rutherford. “Certain salts saturated in water can naturally regulate humidity- we just developed a cannabis-specific humidity level and patented the packaging around it that purifies the water and can come in direct contact with cannabis,” says Rutherford. “Using water activity meters and a moisture isotherm test, we determined the most appropriate range of humidity levels that cannabis will remain stable.” That range turned out to be between 59% and 63% humidity level for the properties in dried cannabis to stay the same.

According to Rutherford, it is a little more complex than just a range to stay in. “There are different humidity levels that certain strains prefer, but there are personal preferences, regions and other factors to consider when determining the levels of humidity ideal for cannabis,” says Rutherford. “We wanted to understand what people consider to be perfect.” In their research they found that depending on the region of the country, that humidity level varies considerably. “Using a water activity meter we could tell exactly what people prefer,” says Rutherford. Colorado, for example, prefers significantly drier cannabis than the Pacific Northwest, according to their findings.

Right now, Boveda has two-way humidity controllers set at 62%, 58% and soon they will have an under 50% option (appealing to the Colorado market). Using a device to accurately control the humidity level in cannabis can help growers and retailers prevent contamination from the biggest source of concern: water. “There is a ton of talk about pesticide contamination, but the reality is even if the flower is grown organically, you can still encounter safety problems when the moisture level is off,” says Rutherford. From a medical perspective, keeping dried cannabis at an ideal humidity level helps stabilize the properties of it, maintaining the medical efficacy. “If this is something people use for a medicine, it should be at an ideal condition,” says Rutherford. “Quantifying and understanding what humidity level is right is what we are helping accomplish.” For patients with compromised immune systems that need safe, consumable cannabis, a humidity control device can help prevent contamination and ensure a certain degree of safety in their medicine.

On a retail level, the packaging insert can extend the shelf life of products and maintain the quality. “The world has known for decades that 70% humidity level for cigars is ideal,” says Rutherford. “The cannabis world hasn’t had a moisture standard or understanding of what is proper until very recently.” That 62% humidity level determined after commissioned testing is a good standard to reference when determining your own ideal humidity level.

Growers also recognize the value in keeping their cannabis at the right humidity level beyond the obvious safety concerns. “As cannabis dries out and loses its humidity, the overall weight is reduced,” says Rutherford. “Precision humidity control gives a uniform humidity throughout the flower, leaving out the mystery for growers and maintaining weight, meeting the nexus between quality and weight.” According to Rutherford, growers have an incentive to package their cannabis a little on the wet side. “Because it weighs the most when wet, it is sold by weight and it will lose moisture over time, the incentive to deliver product that will dry out over time- that can create a lot of problems by having high moisture content.” For the first time ever, people can dramatically extend the shelf life of dried cannabis, instead of letting products naturally deteriorate and go bad over time. “For the first time ever, it allows you to extend the shelf life of dried cannabis for aging cannabis like wine and cigars,” says Rutherford.

The data from that Cannabis Safety Institute report, collected by AquaLab and CannaSafe Analytics using a vapor sorption analyzer, shows a cutoff of 65% relative humidity. These findings give the industry a lot of guidance in working to reduce the amount of yeast and mold contamination, says Bob Esse. “If your dried cannabis is above 65% relative humidity and you are a retailer, you should send that product back to the grower because it wasn’t dried properly, is vulnerable to mold and yeast spores and thus not safe for the consumer,” says Esse.

Pointing to the report, Esse says foods with high moisture content are able to support robust microbial population growth, which can lead to bacterial and fungal infections. “Water activity is what impacts whether microorganisms can grow or not.” By using two-way humidity control technology, growers and retailers can mitigate risks of contamination, improve quality and extend the shelf life of their products.

March 20, 2017

Soapbox

Human Error? No Problem

By Dr. Ginette M. Collazo

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If you are in the business of growing cannabis, you should be aware of the common reasons for production losses, how to address root causes and how to prevent future occurrences in a sustainable way. Human error is the number one root cause identified in investigations for defects in the cultivation business. Sadly, little is known about the nature of these errors, mainly because our quest for the truth ends where it should begin, once we know it was a human error or is “someone’s fault.”

Yes, human error usually explains the reason for the occurrence, but the reason for that error remains unexplained and consequently the corrective and preventive actions fail to address the underlying conditions for that failure. This, in turn, translates into ineffective action plans that result in creating non-value added activities, wasting resources and money as well as product.

Human error can occur when workers are in direct contact with the plant

So after investigating thousands of human error events and establishing systems to improve human reliability in manufacturing facilities, it became even clearer to me, the need to have good, human-engineered standard operating procedures (SOPs).

In the cannabis growing process, there are different types of mistakes that, when analyzed, all can be addressed in the same manner. For example, some common errors that we see are either overwatering or nutrient burn, which can occur when the plant is overfed. The same is true in the opposite scenario; underfeeding or under watering lead to problems as well. If your process is not automated, the reason for these failures was most likely human error. Now, why did the person make that mistake? Was there a procedure in place? Was the employee trained? Is there a specific process with steps, sub-steps, quantities and measures? Were tools available to be able to do the task correctly? There is so much that can be done about these questions if we had clear, well-written and simple, but specific instructions. The benefits greatly outweigh the effort required.

Also, besides providing step-by-step instructions to avoid commission errors (to perform incorrectly as opposed to omit some step), there are other types of errors that can be avoided with SOPs.

Decision making like detecting nutrient deficiencies can lead to human error.

Decision-making is another reason why we sometimes get different results than the ones expected. If during your process there are critical, knowledge-based decisions, workers need to be able to get all the information to detect as well as correct situations. Some decisions are, for example, when (detection) and how (steps) should I remove bud rot? Is there a critical step in the process (caution) to avoid other plants from becoming affected? Any information on the what, how, when, where and why reduces the likelihood of a decision error, later described as obvious.

When we face manufacturing challenges like nutrient deficiency in a particular stage, mold, fungus, gnats or even pollination of females, we want to do whatever we can to prevent it from happening again. So consider that from avoiding to detecting errors, procedures are a critical factor when improving human performance.

Here are some guidelines when writing procedures to prevent human error.

Use them. Enforce the use of procedures at all times. As humans, we overestimate our abilities and tend to see procedures as an affront to our skills.
Make sure it is a helpful procedure and users are involved in the process. People that participate in writing rules are more likely to follow them.
Make sure they are available for their use.
All critical activities should have a procedure.
The procedure needs to be clear, have a good format, clear graphics, appropriate level of detail and specific presentation of limits.
Make sure that facts, sequence and other requirements are correct and all possible conditions are considered e.g. “what if analysis”.

Human error won’t be eradicated unless we are able to really identify what is causing humans to err. If eliminating or “fixing” the actual individual eliminates or potentially reduces the probabilities of making that mistake again, then addressing the employee would be effective. But if there is a chance that the next in line will be able to make the same mistakes, consider evaluating human factors and not the human. Take a closer look and your process, system and ultimately your procedures.

November 16, 2016

Operational Inefficiencies in Commercial Cannabis Cultivation

By Drew Plebani

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From the perspective of sustainable cannabis cultivation models, it seems clear that outside of the particular cultivation methodology adopted, that operational efficiency and the implementation of lean manufacturing principles will be necessary for successful and truly “sustainable” businesses, in the current, ever growing, cannabis space.

Implementing lean manufacturing principles as an integral part of the cannabis cultivation facility just makes sense- it is a manufacturing operation after all. From a lean perspective, doing away with the non-value-added costs in the supply chain and production model are quite important.

Let’s look at this case study as evidence for the necessity of operational efficiency:

A 300-light flowering, indoor cultivation facility in Colorado.

The system was purchased with ongoing pest/disease issues, recent updates to Colorado’s approved pesticide list, had prompted the implementation of an updated integrated pest management (IPM) program, which had been moderately successful in developing an albeit short-term solution to keeping ongoing root aphids, powdery mildew, and botrytis, to name a few, at bay.

This existing facility was producing roughly 60 pounds of trimmed cannabis per week, equivalent to almost $6M annual gross, however they were losing a percentage of their yields to product that did not pass Colorado’s contaminant testing requirements.

It is important to note that any deviation from the existing manufacturing schedule and system would create a change to the potential productivity of the system, for better or worse.

At the most basic level, one would hope that a new operator taking over an existing facility would analyze the system and implement incremental or perhaps major changes to create more efficient and profitable outcomes. That being said, currently the average grower likely doesn’t have much understanding of the lean manufacturing process. That will undoubtedly change.

When we look at basic manufacturing facility operations, on an annual gross potential basis, each daily task not completed on the existing manufacturing timeline is, at least, a 0.3% (1/365) loss in potential productivity. In monetary terms, for this particular facility, each 0.3% equates to a potential $18,000 in lost productivity.

The information that follows is taken from observations during the first week of this facility ownership transition and below is a generalized outline representing just one aspect of the operational inefficiencies (created or existing) that were observed :

Plant group A put into flowering 4 days behind schedule (4 days x 0.3%) =1.2%
Plant group B transplanted 3 days behind =0.9%
Plant group C transplanted 7 days behind =2.1%
Plant group D (clones) taken 7 days behind =2.1%
IPM applications not completed for 7+ days

That equals a 6.3% loss in potential annual productivity, which translates into a rough estimate of up to $378,000 in lost revenue.

Changes to the nutrient program in the midst of the plant’s life cycle had created nutrient deficient plants in all stages of vegetative and flowering growth, coupled with changes to the existing IPM program, all add to the potential losses incurred. Deviations in the plant nutrition program and IPM scheduling are hard to quantify mid-cycle, but will certainly be quantifiable when the hard numbers come home to roost.

These inefficiencies, once compounded, could potentially equal more than a 20% loss in potential productivity during the subsequent 3.5 month plant cycle. The current 60 pounds-per-week would likely be reduced for the next 2 months, down to roughly 50 pounds, or even much less, per-week. This could become a loss upwards of $500,000 in annual potential revenue in the first quarter of operation alone.

These seemingly small and incremental delays in the plant production cycle are all greatly compounded. The end result is that each subsequent cycle of plants is slightly smaller due to delays in transplanting and less days at maximized vegetative growth, etc. Undoubtedly, the cumulative effect of these operational inefficiencies creates a significant drop in the existing level of productivity, with the end result being a significant, undesired loss of revenue.

The sum of the lessons learned from this cultivation facility, is this: a sustainable operation, in the most pragmatic sense, is an efficient one both in terms of productivity and in terms of the carbon footprint and waste generated. The more streamlined and successful the operations are, the greater likelihood of success. Perhaps all of this is to say don’t forget about all the little parts that make up the whole, and strive to create a work environment/corporate culture that empowers your employees, your managers and all involved to participate and contribute to the process of improving the operations for mutual benefit.

Lessons learned from the aerospace manufacturing industry: Even the smallest zip tie on a spaceship matters! Some food for thought: If it’s truly beneficial it should stick around… If it is beneficial and it’s not sticking around, then there are limiting factors in the system that need to be addressed.

November 3, 2016

Soapbox

How Cannabis Can Positively Impact California’s Drought

By Lukian Kobzeff

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As the drought in California persists and quickly becomes the new hydrological norm, many within the state have embraced efforts to find ways and means to live within the drought forced water “budget.” Because of the importance of water conservation, the cannabis industry should embrace its socio-ecological responsibility and seize the opportunity to help shift the perception of cannabis cultivation into that of a sustainable, high-value agricultural crop that can be grown in an environmentally safe manner, while using water efficiently.

The intersection of Prop 64, MCRSA and the drought provides the cannabis industry with a unique opportunity to positively impact water conservation. Because legal cannabis cultivators are just now designing blueprints for grow sites, these cultivators are in a position to build infrastructure and systems specifically designed to achieve permanent, sustainable water conservation.

By embracing and championing water conservation, the cannabis industry will achieve two goals: being a collaborative player in the larger community working towards sustainable water use and enhancing the overall perception of the cannabis industry in the conscious of the general public. For an industry seeking legitimacy, there is no better way to put cannabis in the mainstream conscious than by embracing environmentally responsible philosophies. Here are a few measures the cannabis industry should embrace:

Measure

The current drought has generated a state-wide conversation about tracking and recording water usage. Some commentators believe California is suffering from a water data problem. Recently passed AB 1755 is a step by California to address that shortcoming by creating a technology platform to aggregate and share water data. Cannabis cultivators should get onboard with measuring water usage. One method is to install sensitive flow meters in each drip station to precisely measure water used during each grow cycle. First, this provides the cultivator with a precise data set. Precise data sets are extremely important, especially when trying to achieve the two-part-goal of conserving water and maximizing crop yield. Second, having precise data sets allows the cultivator to determine, from harvest-to-harvest, increasingly precise ratios of input (water) to output (flower). Most likely, this input:yield ratio is subject to diminishing returns at the margin; that is, adding additional water will not proportionately increase crop yield. For instance, 50 units of water could produce 50 units of crop, but 75 units of water might only produce 55 units of crop. By measuring the input (water), the cultivator is able to identify the precise threshold where diminishing returns set in and can therefore reduce the “diminishing returns” water usage, saving money and conserving water.

Collaborate

Building on water-usage data collection, cultivators can then collaborate with each other and with water agencies. By sharing data sets, cultivators can quickly develop ideal input:yield ratios, can better understand how water usage fluctuates within each discreet grow cycle and can develop methods such as deficit irrigation and real-time soil moisture measurements. This collective industry knowledge will help each individual cultivator to reduce water-usage. In collaborating with local water boards, the boards will better understand how much water is being used and conserved by the industry. Additionally, if the boards have a more precise understanding of the expected usage per season or per specific period in a grow cycle required by cultivators in their jurisdictions, those boards can better plan for the peaks and troughs in water demand. Besides data sharing, agencies and cultivators can collaborate in developing “fill stations” (offering free, non-potable recycled water for irrigation), or help fund development of direct potable water technologies and other recycled water technologies. Collaboration amongst growers and with water boards will lead to greater water conservation.

Energy Saving

An ancillary benefit to water conservation behaviors is the reduction of energy consumption. It takes an immense amount of energy to pump and transport water to end-users, such as cultivators. Reducing water usage in turn reduces energy consumption, because less water used means less water transported and disposed of. This is one method for indoor cultivators to offset energy consumption. In addition to reducing energy usage by conserving water, cultivators can follow Irvine Ranch Water District’s example of implementing an energy storage system to reduce costs and ease energy demand during peak hours. Indoor cultivators should adopt the same basic structure and mechanics: install Tesla battery packs to store energy for use during peak hours (when electricity is more expensive) and recharge the batteries at night when demand is low (and electricity is cheaper).

Opportunities Abound

This is an exciting time in California’s history, with the pending election of Prop 64, the passage of MCRSA, and the opportunities present in the water-energy nexus. The $6 billion cannabis industry has an incredible opportunity to have a far-reaching impact on water-conservation. By being an active collaborator conserving water, the cannabis industry can position itself as a trendsetter and private sector leader in sustainable and eco-conscious methods, technologies, and processes.

November 2, 2016

Exploring Opportunities in Emerging Markets

By Aaron G. Biros

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This November 8^th, voters in five states will head to the polls to decide on legalizing recreational cannabis and another three states have ballot initiatives that would legalize medical cannabis. If any of those five states pass a measure for recreational legalization, including Massachusetts, Maine, Nevada, Arizona and California, (which are all leading in the polls) they could potentially create massive new market opportunities for cannabis brands that have their eye on expansion.

Nancy Whiteman, co-owner of Wana Brands and chair of the Cannabis Business Alliance Infused Product Committee, sees great potential in capitalizing on those markets early. Whiteman has been working with Wana Brands since 2010 in Colorado, starting out in the young medical market there.

Nancy Whiteman holding a batch of cannabis gummies

After expanding to the recreational market, Wana Brands saw its sales skyrocket. From January to August 2016, Wana had the best-selling candy brand in Colorado with 21% dollar share, according to BDS Analytics. Wana Brands has already expanded to Oregon and will launch in Nevada on November 15^th, with agreements signed to expand in other states as well. “The model we are pursuing is a licensing agreement where we partner with existing or new license holders in their state,” says Whiteman. “In many ways they are doing the heavy lifting, but we are providing an enormous lift by licensing our intellectual property to them.” That model for growth is becoming increasingly common in some of the more established brands, like Steep Hill Laboratories, GFarma Labs, Dixie and others. Whiteman says that Wana Brands also has a partner in Illinois, Massachusetts and a number of other states they hope to reach.

Mark Slaugh, CEO of iComply

According to Mark Slaugh, executive director of the Cannabis Business Alliance and chief executive officer of iComply, a compliance services provider, brands from Colorado expanding to other states need to ask themselves if their reputation is on the line with these new operators. “If you are licensing to companies that are not compliant, the penalties could be huge and they vary state to state- that could potentially hurt the overall brand image nationally,” says Slaugh. “People doing the licensing that are operating with full compliance really need to look at controlling that risk and mitigating that as much as possible.” With brand trust on the line, there are substantial risks that come with expansion. “We help clients ensure quality is consistent so, for example, an edible product would taste the same in Colorado as it would in Nevada or Arizona. They need to follow the intellectual property consistently but more importantly follow those specific regulations in that state to stay afloat.” Managing ongoing compliance in different states requires monitoring regulatory updates across multiple markets, which can get incredibly complex.

Processing SOPs vary widely stae to state

“Six years ago, it was much easier to get into the market in Colorado,” says Whiteman. “There were no capital requirements, no limits on the number of licenses, but there was still a lengthy application and vetting process- as long as you met those minimum requirements you could get a license.” Other new states put stringent limits on the number of licenses granted and some have extraordinarily cost-prohibitive capital requirements, up to a million dollars, as is the case for New York. “Anyone who becomes a license holder in Massachusetts has to be prepared to embark on three separate business models, which is a massive undertaking,” says Whiteman. Massachusetts requires license holders to cultivate, process and dispense in a vertically integrated model.

In other states, Wana Brands is working with exclusive partners who will have the capabilities to manufacture and distribute throughout the entire state, but in Massachusetts that won’t be the case. “To cover the state, we need several partnerships; the partner we are working with is a little south of Boston,” says Whiteman. But all that could change if voters in Massachusetts legalize it recreationally, opening a much larger market than the current medical program. “With no legislation drafted yet, the regulatory environment is still up in the air in Massachusetts so there is no way of telling what the recreational market will look like.” In terms of ongoing regulatory compliance, Whiteman believes that Colorado still has some of the most stringent rules. The universal symbol printed on every individual edible product serving is one example. “Every state has different lab testing and licensing requirements, but Colorado looks like the most stringent currently,” says Whiteman. “Colorado requires a full gamut of lab testing including homogeneity, potency, residual solvents, contaminants and soon pesticides too.” According to Mark Slaugh, Nevada’s lab testing regulations are fundamentally different from Colorado’s with regard to sampling procedures, but the broader inconsistencies in lab standards need to be addressed. “The lack of laboratory standardization state to state with regard to methods creates a big challenge to get consistent, proficient lab testing across the board,” says Slaugh.

Wana’s edibles come stamped with the universal symbol (THC!) in Colorado, as required by law.

A big differentiator between Colorado and other states is that it was a first mover. “When Colorado came online there were not any established brands to speak of anywhere in the country- we were all pioneers,” says Whiteman. “Because it is so difficult to get a license in another state, either the organization or investor groups are looking to partner with established brands.” The advantages to this business model are many. Expediting your entry to market gets you the advantage of being a first mover. Working with an established brand also minimizes risks and the learning curve. “Bigger players understand that building a brand from scratch is time consuming and expensive so I think we will see a lot of these partnerships.”

As those new states come online, similarities in their regulations might appear in the form of standard operating procedures (SOPs) or good manufacturing practices (GMPs). “We might start to see a standardization from state to state that models FDA GMPs or USDA GAPs, [good agricultural practices] moving toward a framework that is more consistent with the possibility of federal regulation,” says Slaugh. Another commonality among a number of states is the implementation of a statewide tracking system. According to Slaugh, California has no such mandated system in place yet. “They will probably have one eventually but the market is so localized there- we will see if California will be ready with a statewide compliance system for tracking by 2018,” says Slaugh. “With such a weird patchwork of local governments allowing or not allowing certain operations to exist, it is a tough business to be in and it’s getting tougher every day.”