According to an article on Reuters, Uruguay’s pharmacies opened for recreational cannabis sales on Wednesday for those over the age of 18. Uruguay beginning recreational sales marks an important milestone as the first country to fully legalize cultivation, sales and recreational use of cannabis.
The country legalized cannabis more than three years ago, but it has taken a while for the government to work out and implement their regulatory framework. Only two companies, Symbiosis and Iccorp, received government licenses for growing, packaging and distribution, according to Reuters.
Consumers are required to register with the government and are only allowed to purchase up to 40 grams of cannabis per month. 5-gram packages are the only products for sale currently at $6.50 a piece. As of now there are only two types of cannabis that consumers can purchase: “Alfa 1”, and indica, and “Beta 1”, a sativa. According to Reuters, neither has a particularly high concentration of THC.
The government says they will carefully monitor production and registrations to prevent diversion and cannabis leaving the country. Only citizens of Uruguay over 18 are permitted to register to buy cannabis. With over 3.4 million people residing in Uruguay, less than 5,000 have registered by Wednesday. All sales must go through a pharmacy, according to the Reuters article.
According to a press release yesterday sent out by the National Hemp Association (NHA), on Wednesday, June 28th, Board Chairman Geoff Whaling met with senior U.S. Department of Agriculture staff, along with Erica McBride from the Pennsylvania Industrial Hemp Council. The press release says this is the first time that Agricultural Secretary Perdue has had his staff meet with the hemp industry. “The meeting reaffirmed critical elements of the working relationship that the hemp industry has established with the USDA since the enactment of Sec. 7606 of the 2014 Farm Bill,” reads the press release put out by the NHA.
The press release says the USDA will support hemp pilot projects, considering grant and loan applications and other means of funding under the USDA and NIFA. “All hemp industry participants are encouraged to participate in these funding opportunities,” says Whaling. “USDA confirmed that nine Industrial Hemp funding requests to NIFA are being processed and that USDA has encouraged those who submitted previous requests to resubmit them.”
“USDA also offered to provide a quick response to any Secretary or Commissioner of Agriculture who is looking for clarification on either the Farm Bill or SOP, which may be preventing the States that have enacted enabling Industrial Hemp legislation from advancing research,” says Whaling.
A big driver of the meeting was the support of the Industrial Hemp Farming Act of 2018 on behalf of the NHA. That bill, which Congressman James Comer (R-KY) plans on introducing in July, would essentially remove hemp from the Controlled Substances Act, allowing industrial cultivation of the plant. It also would set a THC limit and give states the power to regulate their own hemp industries.
“There is new leadership in the USDA, on the Hill and within our industry,” said Whaling. “I am confident that this group will advance our industry to a level never before achieved.”
According to the Independent, Prime Minister Alexis Tsipras announced last week that Greece will legalize medical cannabis, allowing doctors to write prescriptions for it. “From now on, the country is turning its page, as Greece is now included in countries where the delivery of medical cannabis to patients in need is legal,” says Prime Minister Tsipras at a press conference.
Catalonia, an autonomous region in Spain, legalized consumption of recreational cannabis and cannabis clubs last week. The government voted in favor of the measure with wide support after a 67,500-signature petition brought the debate to the center stage.
According to the Independent, the rules seem relatively restrictive, with measures in place to prevent the capital of Catalonia, Barcelona, from turning into a cannabis tourism capital, such as Amsterdam. One of those rules requires a waiting period for new members of clubs before they can purchase and consume cannabis. However before this measure passed the vote, cannabis clubs were in a legal gray area, with fines for public consumption. These European markets could present excellent opportunities for cannabis companies, which could cause other EU countries make the plunge into legal cannabis.
The Pennsylvania Department of Health announced today the first 12 winners of growing and processing permits for the state’s medical cannabis program. At first glance, it appears those who won the permits have teams with experience in successful cannabis operations elsewhere in the country. The permit winners now have six months to become operational, according to a press release.
According to that press release, John Collins, director of the Pennsylvania Office of Medical Marijuana, received 457 applications in total, with 177 prospective grower/processors and 280 for dispensaries. “With today’s announcement, we remain on track to fulfill the Wolf Administration’s commitment to deliver medical marijuana to patients in 2018,” says Collins. “The applications from the entities receiving permits were objectively reviewed by an evaluation team made up of members from across commonwealth agencies.”
In the populous Southeast region of Pennsylvania, grower/processor permits were awarded to Prime Wellness of Pennsylvania, LLC, and Franklin Labs, LLC. Prime Wellness is a Connecticut-based enterprise. According to Steve Schain, Esq., attorney at the Hoban Law Group, Franklin Labs includes team members from Garden State Dispensary, a successful medical cannabis operation in New Jersey.
Two of the businesses that won permits are actually from Illinois, not Pennsylvania. GTI Pennsylvania, LLC (Green Thumb Industries), has a strong presence in Illinois and Nevada. AES Compassionate Care LLC lists their business state as Illinois as well.
“Based on the first phase award of grower/processor licensees both the strength and weakness of Pennsylvania’s program has been highlighted,” says Schain. “Many licensee recipients are affiliated with existing national marijuana-related businesses with excellent track records for operating in a transparent, compliant and profitable manner.” The applications were rated on a scorecard out of 1,000 points. “Unfortunately missing from this initial phase license winners are purely regional enterprises who may have been unable to compete with national concerns’ resources and checkbooks.” According to Schain, some of the more significant areas on the scorecard reflect a diversity plan, community impact statement, business history and capacity to operate, capital requirements and operational timetable. Capital requirements are the applicants’ demonstrable financial resources comprised of at least $2 million in capital and $500,000 in cash. All of the growers are required to grow indoors, not in a greenhouse or on an outdoor farm.
There is also a ten-day appeals process for scorecards that will undoubtedly be utilized by companies that were not successful in their bids. The next phase, according to Schain, of Pennsylvania’s Medical Marijuana Program regards “Clininical Registrants” in which grow/processor and dispensary licensure will be awarded to eight applicants, which, if able to satisfy requirements including demonstrating $15 million in capital, will be authorized to open up to six dispensary locations.
The Organic Cannabis Association and Ethical Cannabis Alliance announced today they are merging into one organization, the Cannabis Certification Council (CCC), according to a press release. The new third-party certifications include “Organically Grown” and “Fairly Produced”, granting producers a seal for marketing if they achieve the certifications.
According to Ashley Preece of the Ethical Cannabis Alliance, now executive director at CCC, they plan on starting with the “Organically Grown” certification as first certification to market. “We are launching with Organically which will include robust labor standards as well as standards that go beyond [USDA] Organic,” says Preece. “The USDA Organic standard is watered down and we want to expand on proper horticulture practices so it relates directly to cannabis producers.” The process of designing that certification involves using that USDA Organic certification as a building block to draw from but not directly adopt.
“We will start by pulling from Organic and Fair Trade standards, then we will have a technical advisory committee (TAC), made up of multi-stakeholder agricultural industry and cannabis industry professionals to give input and adjust the standard accordingly,” says Preece. “From there we will have a pilot program, engaging with producers abiding by the standards’ requirements. After the pilot phase, we make final adjustments before bringing it to market.” In order to make sure their certification works across the board, Preece says they are engaging with stakeholders around the country and eventually globally. “We need to engage each different community to make sure this is applicable on a national level.” Preece also says they plan staying abreast of other standards, such as ASTM International’s, but those are geared more towards production safety. “We are looking towards more robust Organic and Fair Trade standards, and ‘cannabinizing’ them,” says Preece.
David Bronner, a prominent advocate of drug policy reform and CEO of Dr. Bronner’s, a top-selling soap brand in the US market place, will be providing seed funding and a matching grant to the CCC. “We are committed to making socially and environmentally responsible products of the highest value, and we are excited for the CCC to begin driving that ethos in the cannabis industry,” says Bronner. “The Cannabis Certification Council (CCC), with its unique mission, is a perfect vessel for us to support our values in the cannabis space.”
Preece says the “Fairly Produced” labor certification is going to be based off of Fair Trade practices. “That will include living wages per community and taking options of ownership into consideration, including different business models where employees might have shares or partial ownership,” says Preece. “As we know, this industry has come from the illicit market, where we saw a lot of inappropriate working environments, gender relations and pay schedules. So we want to ensure that workers have contracts in place, they are treated fairly just as any other industry and we want to mitigate any strange encounters that might have seeped into this regulated market.” Founding board members include Laura Rivero of Yerba Buena Farms; Amy Andrle of L’Eagle Services Denver; Nick Richards of Dill and Dill and Vicente Sederberg; and Ben Gelt of Par, with Ashley Preece as executive director. “This is a huge step for the cannabis industry,” says Preece. “Our collaboration reflects the priority of the mission ingrained in both parties, and together we will immediately be greater than the sum of our parts.”
In the first part of this series, we introduced some relevant terms and principles to tissue culture micropropagation and reviewed Dr. Hope Jones’ background in the science of it. In the second part, we went into the advantages and disadvantages of using mother plants to clone and why tissue culture could help growers scale up. In the third part of this series, we are going to examine the five steps that Dr. Jones lays out to successfully micropropagate cannabis plants from tissue cultures.
Cleaning – Stage 0
Micropropagation includes 5 stages. “Stage 0 is the preparation of mother plants and harvest of cuttings for the explant material,” says Dr. Jones. “To ensure the best chance of growing well in culture, those ladies [the mom’s] should be cleaned up and at their best. And hopefully not stressed by insects or pathogens.” She says growers should also make sure the plants are properly fertilized and watered before harvesting explants. “Obtaining the explants is done with a clean technique using new disposable blades and gloves,” says Dr. Jones. “Young shoot tips are harvested and placed in labeled, large Ziploc bags with a small amount of dilute bleach and surfactant solution, then placed in a cooler and taken to the lab.” This is a process that could be documented with record keeping and data logs to ensure the same care is taken for every explant. “Once in the lab, working in the sterile environment of the transfer hood, the cuttings are sterilized, typically with bleach and a little surfactant, and then rinsed several times with sterile water,” says Dr. Jones. Once they reach the sterile environment, Dr. Jones removes the leaves and cuts the stem down to individual nodes.
Establishment – Stage 1
Establishment essentially means waiting for the shoots to develop. Establishing the culture requires an absolutely sterile environment, which is why the first step is so important. “Proper explant disinfection is equally as important is the control parameters of the facility itself,” says Dr. Jones. Mother plants are not grown in sterile facilities, but in an environment that is invariably contaminated with dust, which harbors micro-organisms, insects and other potential sources of contamination, including human handling. We discussed some of this in Part 2.
Explants, once sterilized and placed in the culture vessel, must establish to the new aseptic conditions. “Basically Stage 0 ends when the explants are cleaned and placed in the vessel. Stage 1 begins on the shelf while we patiently sit, watch and wait for the shoot growth,” says Dr. Jones. “Successful establishment means we properly disinfected the explants because the cultures do not become contaminated with bacteria or fungi and new shoot growth emerges.”
Multiplication – Stage 2
This stage is rather self-explanatory as multiplication simplified means generating many more shoots per explant. In order to create a large number of plants needed for meeting the demand of weekly clone orders, Dr. Jones can break up, or subculture, one explant that contains multiple numerous new shoots. “Let’s say one vessel, which originally started with 4 explants each developed four new shoots. Working in the hood, I remove each explant from the vessel and place it on a sterile petri dish. Now I can divide each explant into 4 new explants and then place the four new explant cuttings into their own vessel. In this example, we started with one vessel with 4 explants,” says Dr. Jones. “Which when subcultured 4-6 weeks later, we now have 4 vessels with 16 plants.” This is instrumental in understanding how tissue culture micropropagation can help growers scale without the need for a ton of space and maintenance. From a single explant, you can potentially generate 70,000 plants after 48 weeks, according to Dr. Jones. “Starting with not 1, but 10 or 20 explants would significantly speed up multiplication.” Using tissue culture effectively, one can see how a grower can exponentially increase their production.
Rooting – Stage 3
“When the decision is made to move cultures to the rooting stage, we typically need to subculture the plantlets to a different media formulated to induce rooting,” says Dr. Jones. “In some instances, the media is very dark, and that’s because of the addition of activated charcoal.” Using activated charcoal, according to Dr. Jones, helps darken the rooting environment, which closely mimics a normal rooting environment. “It helps remove high levels of cytokinin and other possible inhibitory compounds,” says Dr. Jones. Cytokinins are a type of plant growth hormone commonly used to promote healthy shoot growth, but it is important to make sure the culture contains the right ratio of hormones, including cytokinin and auxin for maximum root and shoot development. Dr. Jones suggests that growers research their own media formulation to ensure nice, healthy roots develop and that no tissue dies in the process. “With everything I grow in culture, when it comes to media, in any stage and with all new strains, I run some simple experiments in order to refine the media used,” says Dr. Jones. She puts a special focus on the concentrations and ratios of plant hormones in formulating her medias.
“We commonly think of auxin’s role in rooting, but it’s also important in leaves and acts as a regulator of apical shoot dominance,” says Dr. Jones. “So having no auxin may not be ideal for the shooting media used in Stages 1 and 2.” Auxin is a plant hormone that can help promote the elongation of cells, an important step in any plant’s growth. “And cytokinins are typically synthesized in the root and moves through xylem to shoots to regulate mitosis as well as inducing lateral bud branching, so again finding that nice balance between these two hormones is key.”
Acclimation & Hardening Off – Stage 4
“When plants have developed good looking healthy roots, it’s time to pop the top,” says Dr. Jones. This means opening the vessel, another risk for contamination, which is why having a clean environment is so crucial. “The location of these vessels needs to be tightly controlled for light, relative humidity, temperature and cleanliness.” In the culture, sugar is a main ingredient in the medium, because the growing explants are not very photosynthetically active. “By opening the lid of the vessel, carbon dioxide is introduced to the environment, which promotes and enhances photosynthesis, really getting the plants ready for cultivation.”
The very final step in tissue culture micropropagation is hardening, which involves the formation of the waxy cuticle on the leaves of the plant, according to Dr. Jones. This is what preps the plant to actually survive in an unsterile environment. “The rooted plants are removed from the culture vessel, the media washed off and placed in a potting mix/matrix or plug and kept in high humidity and low light,” says Dr. Jones. “Now that there is no sugar, contamination is no longer a threat, and these plants can be moved to the grow facility.” She says conditioning these plants can take one or two weeks. Over that time, growers should gradually increase light intensity and bring down the relative humidity to normal growing conditions.
Overall, this process, if done efficiently, can take roughly eleven weeks from prepping the explants to acclimation and hardening. If growers perform all the steps correctly and with extra care to reduce risks of contamination, one can produce thousands of plants in a matter of weeks.
In the fourth and final part of this series, we are going to dive into implementation. In that piece, we will discuss design principles for tissue culture facilities, equipment and instrumentation and some real-world case studies of tissue culture micropropagation.
If you ask an organic chemist, it’s any molecule with a carbon attached. If you ask a consumer of USDA Certified Organic vegetables, they might say it is food produced without chemicals pesticides, that it is safer and cleaner and even more nutritious. Possibly another consumer will say it’s just a hoax to pay more for food, but what does the USDA Certified Organic Farmer say?
Most will agree it is a very rigorous process of record keeping, fees, rules and oversight. The farmers have limited choices for pesticides and fertilizers; they incur higher labor costs, suffer potentially lower yields and generally have higher input costs. However, at the end of the day the farmer does get a higher price point.
With so many misconceptions about organic food, it is difficult to know what is actually organic by definition. First let’s think about what the word pesticide means. A pesticide is “a substance used for destroying insects or other organisms harmful to cultivated plants or to animals.” By definition, a vacuum used to suck off spidermites is a pesticide, so instead we should say that no synthetic pesticides are used. These are pesticides that enter and reside for long periods of time within the plant, which are potentially harmful to the end consumer. Though organic food does not contain synthetic pesticides, the perception of the food being healthier is also not always accurate. Growers often use foliar applied teas or manures, which increase the chance of the product containing E. coli or other harmful microbes. In addition, certain sanitizing agents or gamma irradiation is not allowed, so the post-harvest cleaning is not always as thorough as for conventional foods. When cannabis is sold as a dried product, the consumer cannot wash the flower as they might do before eating an apple. As growers, we should make sure we are disinfecting the flower before harvest and keeping the plant/processes clean throughout curing.
I often hear cannabis growers saying they are producing an organic product, but this simply cannot be true. The term “organic” is a labeling term for agricultural products (food, fiber or feed) that have been produced in accordance to the federal government’s USDA organic regulations. Due to our (cannabis growers) ongoing disagreements with the federal government, this is not a term we can put on our product. However, we can still grow to the same standards as USDA-certified farmers. How can we do this? By using OMRI (Organic Materials Review Institute) approved products. OMRI is a third-party, nonprofit organization that lets growers know if a product can be used in certified Organic production. You can find this seal on many fertilizers or pesticides.
Next, if it is a pesticide product that is not OMRI approved, check to see if it is registered by the EPA (Environmental Protection Agency). The EPA will provide ingredients and crops that are approved, amounts which can be used safely and storage/disposal practices on the label. Products that are put through the EPA registration are evaluated for their environmental, human and residual risks. Companies pay a hefty fee for this process, and much research goes into providing this information – ALWAYS READ THE LABEL!
A couple of exceptions to an EPA registration are pesticides that are 25B-exempt and biological control. 25B-exempt pesticides are pesticides that pose minimal or no risk to humans. A complete list of these products can be found here. Examples of these pesticides include rosemary, garlic, spearmint, etc.
Biological control is a method for controlling pests by the use of natural enemies. Biological control agents are allowed in organic production. If you are still wondering which pesticides or fertilizer are OK to use in cannabis and you do not live in a state with already enforced regulation, check out allowed lists in states that do.
So we know we cannot be considered a USDA organic cannabis farmer, but we CAN strive to meet the same standards:
Follow your state’s regulations; they are there for a reason!
Use OMRI products, 25B-exempt products and BCAs.
Keep an eye out for upcoming third-party certification companies, such as Clean Green or MPS (beware of the ones that want you to only use their products), because we need more than the state to regulate what we put onto our crop.
Finally, always think about the microbial load you’ve put on your plants. Although many can be very beneficial and help to produce high quality crops, many species can be harmful to the end user.
In the first installment of this three-part series we explored the reasons why cannabis breeders should adopt a strong IP strategy sooner rather than later and looked briefly at the types of IP that those breeders and growers should be considering. In this second installment, we will examine in more detail patent protection for innovative new varieties of cannabis and how one can use that patent protection to further their business objectives.
What is a patent and what do I do with one?
A patent is a right granted by the government to protect a new and useful invention. Importantly, a patent gives its owner an exclusionary right as opposed to a right to do something – the patent owner has the right to exclude others from making, using, selling, offering to sell, or importing the invention (or, for a plant, any of its plant parts) for the term of the patent, which is 20 years for the types of patents that can be used to protect new cannabis varieties.
Because it is an exclusionary right, there are essentially two things that a patent owner can use a patent to do: 1) disallow anyone else from producing and selling that variety (or any of its parts) so that the patent owner is able to capture all of the sales for that variety, or 2) use license contracts to allow other growers to grow the variety while paying royalties back to the patent holder. The latter option can often be beneficial because it can greatly expand production of the variety by licensing to multiple growers. However, this does require some oversight on the part of the patent holder to make sure that the product those growers are producing is high quality –growers who produce poor quality product can hurt the existing brand. Cannabis breeders should consider these options up front when formulating their IP strategy.
Which type of patent should I use to protect my new variety?
As a further consideration, there are two different types of patents that can be used to protect new plant varieties and there are multiple factors to consider when determining which one to pursue.
U.S. Plant Patents are a special type of intellectual property that is used solely for the protection of asexually/vegetatively reproduced plant varieties. Traditionally, plant patents have been used to protect new varieties of ornamental and fruit trees and shrubs, such as a new variety of rose bush or a new variety of apple tree, such as the ‘Honeycrisp’ apple tree, patented in 1990. This type of patent has recently been used to protect a new cannabis variety called ‘Ecuadorian sativa’, while several other cannabis varieties, ‘Midnight’, ‘Erez’, and ‘Avidekel’ varieties are awaiting plant patent approval.
On the other hand, a “utility patent” can be used for new “compositions” (e.g., a new type of grow light) or new types of “methods” (e.g., a new method of extracting compounds from cannabis or a new method of growing cannabis to produce higher THC content). This type of patent can also be used to protect a new plant variety so long as the applicant can demonstrate that the variety is novel and not obvious over what was already known in the art. To date, two utility patents have been issued to protect cannabis varieties that exhibit certain cannabinoid and terpene profiles (U.S. Patent Nos. 9,095,554 and 9,370,164), and other similar utility patent applications are also pending (e.g., U.S. Patent Pub. No. 2014/0298511).
One of the main determining factors in deciding which type of patent to pursue is the nature of the invention. Growers and breeders will likely want to seek a plant patent if they have developed a new variety of cannabis plant: 1) which was made using simple breeding techniques, 2) which can be stably reproduced in an asexual manner (such as by cuttings and cloning), and 3) which is different from its parents and certain other strains on the market, but not completely distinct from everything that already exists. On the other hand, growers and breeders may want to consider a utility patent if they have developed a new variety of cannabis plant: 1) which has unique features in comparison to everything else that exists today (such as a unique disease resistance or chemical makeup), 2) which has unique features that can be demonstrated by some sort of biological or chemical test, and 3) that can be reproduced either asexually or by seed. It is also important to keep in mind that these two routes are not mutually exclusive – one could apply for both types of patent if the variety satisfies the criteria for both.
Though there are numerous similarities between the processes for obtaining both types of patents, there are also clear differences that should be taken into consideration when making the decision about which type of patent to seek. For instance, the grant rate for plant patents is much higher, meaning there is a higher likelihood that the plant patent application will eventually be granted compared to a utility patent application. Further, plant patent applications typically move quicker through the Patent Office, frequently being granted in approximately 18 months, while utility patent applications typically take two to four years (or more) to issue.
Another factor that should be considered is cost. Because a plant patent application is much simpler to prepare and typically moves through the Patent Office more swiftly, the cost for obtaining a plant patent is generally significantly lower than for a utility patent.
Determining which type of patent to pursue requires consideration of numerous factors. However, it is important to keep in mind that, regardless of which type of patent a grower or breeder seeks, there are certain time limitations that can impact the right to obtain a patent. For example, patent protection can only be sought if the variety to be patented has not been sold, offered for sale, or otherwise made publicly available more than one year before the patent application is filed. After that time, the invention becomes part of the “public domain.” So if a breeder chooses to wait to seek patent protection for a new variety, they risk losing the ability to ever get that protection.
Clearly, growers and breeders have to weigh several options when formulating a patent strategy, including what type of patent to pursue and what to do with the patent once they obtain it. Thinking through these issues early on allows the cannabis breeder an opportunity to formulate a strategy that is most beneficial in furthering their business objectives. Additionally, regardless of the type of patent strategy used, it is often helpful to combine it with trademark and branding strategy, which allows the business to utilize a more comprehensive approach to IP for their innovative strains. The third installment of this series will focus on trademarks for cannabis products and some unique issues that facing the cannabis industry today.
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.
Hazard analysis and critical control points (HACCP) is a robust management system that identifies and addresses any risk to safety throughout production. Originally designed for food safety through the entire supply chain, the risk assessment scheme can ensure extra steps are taken to prevent contamination.
The FDA as well as the Food Safety and Inspection Service currently require HACCP plans in a variety of food markets, including high-risk foods like poultry that are particularly susceptible to pathogenic contamination. As California and other states develop and implement regulations with rigorous safety requirements, cannabis cultivators, extractors and infused product manufacturers can look to HACCP for guidance on bolstering their quality controls. Wikipedia actually has a very helpful summary of the terms referenced and discussed here.
The HACCP system consists of six steps, the first of which being a hazard analysis. For Dr. Markus Roggen, vice president of extraction at Outco, a medical cannabis producer in Southern California, one of their hazard analyses takes place at the drying and curing stage. “When we get our flower from harvest, we have to think about the drying and curing process, where mold and bacteria can spoil our harvest,” says Dr. Roggen. “That is the hazard we have to deal with.” So for Dr. Roggen and his team, the hazard they identified is the potential for mold and bacteria growth during the drying and curing process.
The next step in the HACCP system is to identify a critical control point. “Correct drying of the flower will prevent any contamination from mold or bacteria, which is a control point identified,” says Dr. Roggen. “We also have to prevent contamination from the staff; it has to be the correct environment for the process.” That might include things like wearing gloves, protective clothing and hand washing. Once a control point is identified, the third step in the process is to develop a critical limit for those control points.
A critical limit for any given control point could be a maximum or minimum threshold before contamination is possible, reducing the hazard’s risk. “When we establish the critical limit, we know that water activity below 0.65 will prevent any mold growth so that is our critical limit, we have to reach that number,” says Dr. Roggen. The fourth step is monitoring critical control points. For food manufacturers and processors, they are required to identify how they monitor those control points in a written HACCP plan. For Dr. Roggen’s team, this means using a water activity meter. “If we establish the critical control point monitoring, water activity is taken throughout the drying process, as well as before and after the cure,” says Dr. Roggen. “As long as we get to that number quickly and stay below that number, we can control that point and prevent mold and bacteria growth.”
When monitoring is established and if the critical limit is ever exceeded, there needs to be a corrective action, which is the fifth step in a HACCP plan. In Dr. Roggen’s case, that would mean they need a corrective action ready for when water activity goes above 0.65. “If we don’t have the right water activity, we just continue drying, so this example is pretty simple,” says Dr. Roggen. “Normal harvest is 7 days drying, if it is not dry enough, we take longer to prevent mold or bacteria growth.”
The sixth step is establishing procedures to ensure the whole system works. In food safety, this often means requiring process validation. “We have to double check that our procedure and protocols work,” says Dr. Roggen. “Checking for water activity is only a passive way of testing it, so we send our material to an outside testing lab to check for mold or bacteria so that if our protocols don’t work, we can catch those problems in the data and correct them.” They introduced weekly meetings where the extraction and cultivation teams get together to discuss the processes. Dr. Roggen says those meetings have been one of the most effective tools in the entire system.
The final step in the process is to keep records. This can be as simple as keeping a written HACCP plan on hand, but should include keeping data logs and documenting procedures throughout production. For Dr. Roggen’s team, they log drying times, product weight and lab tests for every batch. Using all of those steps, Dr. Roggen and his team might continue to update their HACCP plans when they encounter a newly identified hazard. While this example is simplistic, the conceptual framework of a HACCP plan can help detect and solve much more complex problems. For another example, Dr. Roggen takes us into his extraction process.
Dr. Roggen’s team, on the extraction side of the business, uses a HACCP plan not just for preventing contamination, but for protecting worker safety as well. “We are always thinking about making the best product, but I have to look out for my team,” says Dr. Roggen. “The health risk to staff in extraction processes is absolutely a hazard.” They use carbon dioxide to extract oil, which carries a good deal of risks as well. “So when we look at our critical control points we need to regularly maintain and clean the extractor and we schedule for that,” says Dr. Roggen.
“My team needs respirators, protective clothing, eyewear and gloves to prevent contamination of material, but also to protect the worker from solvents, machine oil and CO2 in the room.” That health risk means they try and stay under legal limits set by the government, which is a critical limit of 3,000 ppm of carbon dioxide in the environment. “We monitor the CO2 levels with our instruments and that is particularly important whenever the extractor is opened.” Other than when it is being opened, Dr. Roggen, notes, the extractor stays locked, which is an important worker safety protocol.
The obvious corrective action for them is to have workers leave the room whenever carbon dioxide levels exceed that critical limit. “We just wait until the levels are back to normal and then continue operation,” says Dr. Roggen. “We updated our ventilation system, but if it still happens they leave the room.” They utilize a sort of double check here- the buddy system. “I took these rules from the chemistry lab; we always have two operators working on the machine on the same time, never anyone working alone.” That buddy check also requires they check each other for protective gear. “Just like in rock climbing or mountain biking, it is important to make sure your partner is safe.” He says they don’t keep records for employees wearing protective gear, but they do have an incident report system. “If any sort of incident takes place, we look at what happened, how could we have prevented it and what we could change,” says Dr. Roggen.
He says they have been utilizing some of these principles for a while; it just wasn’t until recently that they started thinking in terms of the HACCP conceptual framework. While some of those steps in the process seem obvious, and it is very likely that many cannabis processors already utilize them in their standard operating procedures and quality controls, utilizing the HACCP scheme can help provide structure and additional safeguards in production.
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.
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?