Tag Archives: compliance

Canopy_Growth_Corporation_logo

Focus on Canopy Growth: International Pioneer On A Global Mission

By Marguerite Arnold
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Canopy_Growth_Corporation_logo

Read the glossy website or encounter their expensive marketing materials and lush swag at any upscale international cannabis business conference these days and you get a certain kind of impression. The new, modernist, chic European HQ in central Frankfurt, for example, with its floor-to-ceiling windows and breath-taking view of the city, river and mountains, continues to give that perspective far from home.The company has been at the forefront of the Canadian cannabis industry since 2013 and has subsequently weathered several mergers, buyouts and creative partnerships of all kinds.

But what’s of great interest about Canopy is that its highly slick corporate image is backed up by a solid performance elsewhere to date– and on a number of important, and globally impactful levels. Further, the company’s willingness to think strategically, globally, and take calculated, well-timed risks at the same time proves to be effective.

The Canadian Beginnings

The company has been at the forefront of the Canadian cannabis industry since 2013 and has subsequently weathered several mergers, buyouts and creative partnerships of all kinds. In the process it has also made financial history in the cannabis industry, becoming the first publicly listed cannabis company in the world a year after its founding.

Canopy_Growth_Corporation_logoSo much of its iconic corporate history is in fact, ironically fading in the rapid birth of the full on recreational market at home. However, here is the elevator pitch. Born as Tweed, in 2013, in an abandoned former Hershey chocolate plant and the recipient of one of Canada’s first medical cultivation licenses, the company rapidly expanded with increased market access that reform brought. Inevitably, its success also spawned one of its closest competitors (Cannabis Wheaton Income Corp) after co-founder Chuck Rifici was ousted by a unanimous vote of the Canopy board.

In 2018, Canopy Growth still maintains its reputation as the first Canadian cannabis unicorn, even though its stock price is just half that of close competitor, Tilray.

In Canada, the company has long expanded adroitly beyond its central HQ with strategic partnerships and buyouts that range the gamut of grow and branding opportunities that are becoming increasingly as mainstream as, well, beer. These days, Canopy is well-poised to take advantage of the shifting Canadian regulatory landscape on several fronts.

The first is undeniably medical. The company has made patient access a cornerstone of its continuing market development strategy. In fact, current CEO and original cofounder, Bruce Linton, has recently told the press that in his view the medical market globally is the company’s first and most profitable focus.

No matter how many beer companies come calling. And that is also one of the company’s more notable, if not newsworthy accomplishments.

International Aspirations

However it is on the international side that the company has really distinguished itself. That starts with the early (relatively speaking) and active interest in what was going on far from Canadian shores. Initially in Europe (but not limited to it). And even more centrally, how and where the company expanded its global medical reach.Canopy has spread its influence widely throughout Europe already

That started, from the Canopy perspective, with the decision to buy the small German GmbH called MedCann (now Spectrum Cannabis, the global medical brand of Canopy). Located just south of Frankfurt, an international but small team of globally experienced entrepreneurs managed to obtain the first import license for medical flower from Canada into Germany in the summer of 2016. Guided by the industry knowledge and business savvy if not entrepreneurial zeal that so often leads to naught, Pierre Debs and team faced a market still sceptical of medicinal cannabis domestically, and the burden of being “first.” Canopy was not yet in Europe, but they had more ready access to the market and capital. The Canopy buyout of MedCann was accomplished on December 12, 2016, six months before the first iteration of the German cultivation bid was announced. Canopy later announced that it had become one of the top ten finalists in the first iteration of the now restarted German cultivation bid.

Beyond Germany however, this unique team with deep local and global knowledge also began an immediate expansion policy in Europe and beyond that is still unfolding. Apparently in similar strategy adopted at home in the Canadian provinces, Canopy has spread its influence widely throughout Europe already. With an enormous supply contract from Spain’s Alcaliber and operations in Denmark, the Czech Republic, Poland, Italy and a few more (still currently unnamed) operations rolling out any day, the company is clearly building a solid, strategically dispersed infrastructure that reaches far beyond Europe, with global impact and influence.

Exhibit A? In April of this year, the company launched Spectrum Australia with support from the Victorian government.

Controversies

The biggest controversy facing the company so far, albeit indirectly, involves pesticides. This issue occurred during the acquisition of an outside company called Mettrum. In other words, Canopy inherited the production liabilities of a purchased company. The acquisition, however, which passed the buck to Canopy to fix, was actually an opportunity for Canopy to implement its own high internal production and quality controls throughout Mettrum facilities.

This was not inexpensive or of small impact (it affected 21,000 medical users). In addition to taking a leadership role in addressing their acquisition’s production issues, CEO Linton publicly apologized to affected patients.

The company has also been on the forefront of the banking and financing regulatory problems that have plagued the industry (so far successfully).

Image 2: Temperature display provides quick view of sensor data

10 Questions To Ask Before Installing a Remote Monitoring System

By Rob Fusco
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Image 2: Temperature display provides quick view of sensor data

No matter the size of your cannabis greenhouse operation, keeping your plants alive and healthy requires the best possible growing environment. This means greenhouse managers and personnel must frequently monitor the status of environmental conditions and equipment. The sooner someone discovers extreme temperature fluctuations, rising humidity or equipment failure, the more inventory you can save.

Image 1: Cloud-based remote monitoring system in protective enclosure
Cloud-based remote monitoring system in protective enclosure

That’s why integrating a remote monitoring system into your greenhouse operation can save you time, money and anxiety. Monitoring systems that use cloud-based technology let you see real-time status of all monitored conditions and receive alerts right on your mobile device.

Installing a monitoring system and sensors can be easier than you might think. Here are answers to ten questions to ask before installing a cloud-based monitoring system:

  1. What is required to use a remote monitoring system?

Most remote monitoring systems require an internet or WiFi connection and access to an electrical outlet. Programming is done through a website, so it’s easiest to use a computer for the initial setup. If you don’t have an internet connection at your location, you’ll want to choose a cellular system. Make sure that there’s sufficient signal strength at your site, and check the signal quality in the area before purchasing a cellular device.

2. How do we determine what kind of monitoring system and sensors we need?

A reputable manufacturer will have a well-trained support team that can assess your needs even without a site visit to determine which products are best for your application. If you feel you need them to check out your greenhouse operation,many companies can set up a video conference or FaceTime chat to substitute for being on site.

You will want to provide details about the scope and purpose of your cannabis growing operation. Important factors to discuss include:

  • Skeletal structure of the greenhouse (metal, plastic, wood, etc.) and the covering material (glass or plastic).
  • Floor space square footage and height of each of your greenhouses.
  • Number of greenhouse structures in your operation.
  • Outdoor climate to determine if you rely more on heating or air conditioning and the level of humidity control needed.
  • Space dedicated to phases of growth (cloning and propagation, vegetative, flowering) and the microclimates needed for each.
  • Types of lighting, ventilation and irrigation systems.
  • Level of technological automation versus manual operation in place.

The monitoring system representative will then determine the type of system that would best serve your operation, the number of base units you will need and the types of sensors required.

Image 2: Temperature display provides quick view of sensor data
Temperature display provides quick view of sensor data

The representative should also be able to provide tips on the placement of the sensors you’re purchasing. For example, to ensure thorough air temperature coverage, place sensors throughout the greenhouse, next to the thermostat controlling the room temperature and in the center of the greenhouse out of direct sunlight.

Note that there shouldn’t be a cost for a demo, consultation or assistance throughout the sales process. Be sure to ask if there are any fees or licenses to keep using the monitoring equipment after you purchase it.

3. Are sensors included with the monitoring system?

In most cases, sensors are sold separately. The sensors you select depend upon the conditions you want to monitor and how many you can connect to your base unit. Certainly, temperature is critical, but there are many other factors to deal with as well, such as humidity, CO2, soil moisture, water pH, power and equipment failure, ventilation and physical security.

For example, humidity has a direct impact on the photosynthesis and transpiration of plants. High humidity can also cause disease and promote the growth of harmful mold, algae and mildew. Sensors can detect changes in humidity levels.

Image 3: Water pH sensor
Water pH sensor

Like any other plant, cannabis needs COto thrive, so it’s a good idea to include a COsensor that will signal to the monitoring device when readings go out of the preset range. There are even sensors that you can place in the soil to measure moisture content to help prevent over- or underwatering, budget water usage costs, promote growth and increase crop yield and quality.

Of course, all the critical systems in your growing facility—from water pumps to irrigation lines to louvers—rely on electrical power. A power outage monitoring sensor detects power failure. It can also monitor equipment for conditions that predict if a problem is looming, such as power fluctuations that occur at specific times.

Ventilation systems not only help control temperature, they also provide fresh air that is critical to plant health. Automated systems include features like vented roofs, side vents and forced fans. Sensors placed on all these systems will send personnel an alert if they stop running or operate outside of preset parameters.

To monitor the physical security of your greenhouses, you can add sensors to entrance doors, windows, supply rooms and equipment sheds. During off hours, when no staff is on duty, you can remain vigilant and be alerted to any unauthorized entry into your facility.

4. Do monitoring systems only work with the manufacturer’s sensors?

Not necessarily. For example, certain monitoring units can connect with most 4-20mA sensors and transmitters regardless of the brand. When selecting sensors, you might have a choice between ones that are designed by the manufacturer to work specifically with the monitoring system or universal components made by a third party. If the components aren’t made by the system manufacturer, you’ll want to find out if they have been tested with the monitor you are choosing and if you need to work with another vendor to purchase the parts.

A humidity sensor mounted in a weatherproof enclosure
A humidity sensor mounted in a weatherproof enclosure

5. Is a monitoring system easy to set up, or do we need to hire an electrician?

Many monitoring systems are quick and easy to install, and users can often set them up without hiring an outside expert. Look for one that requires only a few simple physical installation steps. For example:

  1. Mount the device to the wall or somewhere secure;
  2. Plug it into an electrical outlet and an internet connection;
  3. Connect the sensors.

You connect the sensors to the base unit’s terminal strip using wire, which is included with many sensors. The range of many wired sensors can be extended up to 2,000 feet away from the base unit by adding wire that can be easily purchased at any home store. It’s a good idea to hire an electrician if you need to run wires through walls or ceilings.

Usually, once you plug in the device and connect the sensors, you then create an account on the manufacturer’s designated website and begin using your device. There should be no fee to create an account and use the site.

If the manufacturer doesn’t offer installation services, ask if they can recommend a local representative in your area who can set up your system. If not, make sure they provide free technical support via phone or email to walk you through the installation and answer any questions you might have about programming and daily usage.

6. Is there a monthly fee to access all the functionality of a monitoring device?

Many web- or cloud-based systems provide free functionality with some limitations. You might have to purchase a premium subscription to unlock features such as text messaging, phone call alerts and unlimited data logging access.

 7. Should we get a system that is wired or wireless? Will we need to have a phone line, cable, internet or something else?

Wireless can mean two different things as it relates to monitoring: how the system communicates its data to the outside world and how the sensors communicate with the system.

The most popular systems require an internet or WiFi connection, but if that’s not an option, cellular- and phone-based systems are available.

A hardwired monitoring system connects the sensors to the base device with wires. A wireless system uses built-in radio transmitters to communicate with the base unit. Some monitoring systems can accommodate a combination of hardwired and wireless sensors.

8. Can one system monitor several sensor inputs around the clock?

Once the monitoring system is installed and programmed, it will constantly read the information from the sensors 24/7. Cloud-based systems have data logging capabilities and store limitless amounts of information that you can view from any internet-connected device via a website or app.

If the system detects any sensor readings outside of the preset range, it will send an alarm to all designated personnel. The number of sensors a base unit can monitor varies. Make sure to evaluate your needs and to select one that can accommodate your present situation and future growth.

When a monitoring system identifies a change in status, it immediately sends alerts to people on your contact list. If you don’t want all your personnel to receive notifications at the same time, some devices can be programmed to send alerts in a tiered fashion or on a schedule. Multiple communications methods like phone, email and text provide extra assurance that you’ll get the alert. It’s a good idea to check the number of people the system can reach and if the system automatically cycles through the contact list until someone responds. Some systems allow for flexible scheduling, so that off-duty personnel don’t receive alerts.

9. Do monitoring systems have a back-up power system that will ensure the alarming function still works if the power goes out or if someone disconnects the power?

The safest choice is a cloud-based system that comes with a built-in battery backup that will last for hours in the event of a power failure. Cloud-based units constantly communicate a signal to the cloud to validate its online status. If the communication link is interrupted—for example by a power outage or an employee accidently switching off the unit—the system generates an alarm indicating that the internet connection is lost or that there is a cellular communications problem. Users are alerted about the disruption through phone, text or email. All data collected during this time will be stored in the device and will be uploaded to the cloud when the internet connection is restored.

If you opt for a cloud-based monitoring system, make sure the infrastructure used to create the cloud platform is monitored 24/7 by the manufacturer’s team. Ask if they have multiple backups across the country to ensure the system is never down.

10. What should we expect if we need technical support or repairs to the system?

Purchase your system from a reputable manufacturer that provides a warranty and offers full repair services in the event the product stops working as it should. Also, research to make sure their tech support team is knowledgeable and willing to walk you through any questions you have about your monitoring system. Often, support specialists can diagnose and correct unit setup and programming issues over the phone.

It helps to record your observations regarding the problem, so the tech team can look for trends and circumstances concerning the issue and better diagnose the problem. Ideally, the manufacturer can provide loaner units if your problem requires mailing the device to their facility for repair.

Logistics and Supply Chain Management in California

By Aaron G. Biros
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Just a couple weeks away, the California Cannabis Business Conference, taking place in Anaheim, CA October 22-23, will host a series of panel discussions where attendees can expect to learn from industry leaders on a variety of topics. As businesses in the state adjust to new regulations and the market matures, one particular topic seems to highlight a challenging new space: distribution.

Track 1 at the CA Cannabis Business Conference, Distribution, Retail and Delivery, will begin early afternoon on Monday at the show, where a panel discussion titled State of Cannabis Distribution: Scaling Cannabis Distribution and Expectations of a Distributor, will tackle a range of issues involving logistics and supply chain management in California’s cannabis industry.

Michael Wheeler, vice president of Policy Initiatives at Flow Kana, will host the panel, joined by Chris Coulombe, CEO of Pacific Expeditors, Jesse Parenti, programs director of Nine Point Strategies and Brian Roth, vice president of sales at KUDU Technologies. According to the agenda, the session will cover inventory management, shipping and transport, managing product data, order fulfillment, manifest creation and reporting on it all. Michael Wheeler says regulatory compliance is one issue they plan on discussing. “Currently the biggest pressure on compliance is the desire by some operators to live under the proposed regulations, instead of the current emergency regulations,” says Wheeler. “Add to this recently signed legislation and we have lots of opportunistic actions each with their own perception of compliance.”

Another important topic they plan on discussing is driver training and hiring practices. According to Chris Coulombe, drivers are one of the top two most important customer-facing teams in the organization. “Between the sales team and the fleet operation, drivers represent half of the face of your company,” says Coulombe. “Much like the sales team, they interface with your retail partners directly, and subsequently provide a sizable portion of the foundation that retailers will use to judge your company’s competency and efficiency.”

Chris Coulombe, CEO of Pacific Expeditors
Chris Coulombe, CEO of Pacific Expeditors

When hiring new drivers, Coulombe recommends the standard background and driver record checks, but urges looking for experience in sales and driving as well. “Find those that have leadership experience and are comfortable operating in quasi-structured environments,” says Coulombe. “To that end, we seek solution oriented candidates that are personable, experienced in troubleshooting on their feet, and understand how to operate inside the structure of an organization.”

Coulombe also emphasizes the importance of driver training in any distribution company. “We built our driver training from scratch based on collective experiences from the military,” says Coulombe. “However, creating this from scratch is not necessary at this point, some insurance companies, such as our broker, Vantreo, provide in house driver training and certification solutions as a risk mitigation measure for companies that they represent. We recommend speaking with your insurance company to find what packages they have available.” Proper training for your drivers can help increase efficiency in operations, decrease maintenance and insurance costs and provide for better employee engagement. Coulombe also says many insurance companies have standard operating procedures for drivers to help supplement your company’s protocols.

Chris Coulombe and the other panelists will dive much deeper into this issue and other supply chain topics at the upcoming California Cannabis Business Conference, taking place in Anaheim, CA October 22-23.

FSC logo

Lab Accreditation Bodies To Meet At Food Safety Consortium

By Aaron G. Biros
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FSC logo

The Food Safety Consortium, taking place November 13-15 in Schaumburg, Illinois, will host a series of talks geared towards the cannabis industry this year. The newly launched Cannabis Quality Track features a number of panels and presentations designed to highlight the many intersections between food safety and cannabis.

FSC logoThe track will have presentations discussing food safety planning in cannabis manufacturing, HACCP, GMPs, regulatory compliance and supply chain issues among other areas. One particular topic of interest in the quality and safety of cannabis products is laboratory testing. At the event this year, leading laboratory accreditation bodies in the country will sit together on a panel titled Accreditation, Regulation & Certification: Cannabis Labs and Production.

Roger Muse, vice president at ANAB

Representatives from ANSI-ASQ National Accreditation Board (ANAB), the American Association for Laboratory Accreditation (A2LA) and Perry Johnson Laboratory Accreditation (PJLA) will host the panel on the morning of Wednesday, November 14.

Panelists will include:

  • Roger Muse, vice president of business development of ANAB
  • Christopher Gunning, life sciences accreditation manager with A2LA
  • Tracy Szerszen, president/operations manager, PJLA
  • Lauren Maloney, food safety program accreditation manager, Perry Johnson Registrars Food Safety, Inc. (PJRFSI)
Tracy Szerszen
Tracy Szerszen, president/operations manager, PJLA

Laboratories that are new to the industry and looking to get accredited should be aware of the new ISO/IEC 17025:2017 standard, which was released last year. According to Tracy Szerszen, labs that have already been accredited to the 2005 version will be required to transition to the 2017 version by November 29, 2020. “This can be done in conjunction with routine assessments scheduled in 2019 and 2020,” says Szerszen. “However, laboratories are cautioned to transition within a reasonable timeframe to avoid their 17025: 2005 certificate from lapsing prior to the transition deadline. Some of the changes to the standard include but are not limited to: the re-alignment of clauses similar to ISO 9001:2015 and other ISO industry standards, modifications to reporting and decision rules, the addition of risked based thinking and a new approach to managing complaints.” Szerszen, along with the other panelists, will go much more in-depth on changes to the new ISO 17025 and other topics during the panel at the Food Safety Consortium.

Some of the other topics the panel will discuss include:

  • ISO/IEC 17025 –what’s expected, benefits of accreditation, common deficiencies, updates to the new 17025 standard
  • Standards available for production facilities-GMPs & GFSI standards
  • How standards can be used to safeguard the quality of production and safety requirements
  • An open discussion with panelists from leading accreditation bodies on the state of cannabis lab testing
Christopher Gunning, life sciences accreditation manager with A2LA
Christopher Gunning, life sciences accreditation manager with A2LA

According to Chris Gunning, many states are requiring accreditation to ISO/IEC 17025, the standard used throughout the world in many other high-profile industries such as the testing of food and pharmaceuticals, environmental testing, and biosafety testing. “In an industry where there are few standard methods, where one hears that you can ‘pay to play,’ and where there are ‘novice’ laboratories popping up with little experience in operating a testing laboratory, it is extremely important to have an experienced, independent, 3rd party accrediting body evaluating the laboratory,” says Gunning. “This process confirms their adherence to appropriate quality management system standards, standard methods or their own internally developed methods, and can verify that those methods produce valid results. Ultimately, the process of accreditation gives the public confidence that a testing laboratory is meeting their state’s requirements and therefore consumers have access to a quality product.” He says most states with legal cannabis recognize the need for product testing by a credentialed laboratory.

Lauren Maloney, food safety program accreditation manager, Perry Johnson Registrars Food Safety, Inc. (PJRFSI)

Another important topic that the panel will address is the role of food safety standards in the cannabis industry. Lauren Maloney says cannabis product manufacturers should consider GMP and HACCP certifications for their businesses. “Food safety is important to the cannabis industry because although individual states have mandated several food safety requirements there still considerable risks involved in the production of cannabis products,” says Lauren Maloney. “Consumers want the assurance that the cannabis products are safe and therefore should be treated like a food product. Because FDA does not have oversight of these production facilities, third party certification is essential to ensure these facilities implement a robust food safety system.”

The panelists will examine these issues along with other topics in greater detail during their talk at this year’s Food Safety Consortium.

Richard Naiberg
Quality From Canada

Protecting Intellectual Property in Canada: A Practical Guide, Part 2

By Richard Naiberg
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Richard Naiberg

Editor’s Note: This is the second article in a series by Richard Naiberg where he discusses how cannabis businesses can protect their intellectual property in Canada. Part 1 introduced the topic and examined the use of trade secrets in business. Part 2 goes into how business owners can protect new technologies and inventions through applying for patents.


Patents: Protection For New And Inventive Technology

Patents, which are issued in accordance with Canada’s Patent Act, provide their owners with the right to have a Court prevent anyone else in Canada from making, using, selling, importing or exporting what is claimed as the patent’s invention. The owner of the patent enjoys this monopoly for a period of 20 years from the date the patent is applied for. A patent is infringed even if the infringer arrives at the invention independently, without actual copying. If a patent owner brings a lawsuit and the Court finds infringement, the Court will typically order the infringing activity to cease and require the infringer to pay the owner a suitable amount of compensation.

There are several drawbacks to applying for a patent from the point of view of the applicant.Patents are meant to protect only inventions, meaning novel, non-obvious and useful solutions to practical problems. In the cannabis field, such inventions could include engineered genetic sequences or new plant cells that lead to useful improvements in the whole plant, new cultivation processes, new methods of extraction, new methods of storage or means to enhance stability, new formulations for administration, and new uses for the plant. It would not be uncommon for a cannabis producer to hold a suite of different patents that cover a whole range of innovative technologies and innovative business methods.

Not all classes of technical innovations are protectable by patent. For example, patents are not available for a whole cannabis plant because no patents are allowed on higher, multicellular organisms. Patents are not issued for genetic sequences or cells that are the result of cross breeding. Patents are also unavailable to monopolize methods of using cannabis as a medical treatment. That said, patent agents are skilled at casting innovations in areas such as these in terms that do provide some patent rights.

To obtain a patent, the applicant hires a patent agent to prepare and submit an application to the Canadian Intellectual Property Office (CIPO). An examiner at CIPO reviews the application for compliance with the statutory requirements and enters into a correspondence with the applicant’s patent agent in a process known as a patent prosecution. Third parties also have the opportunity to oppose the grant of a patent on limited grounds. The prosecution may continue for a period of years before the application is either allowed to issue to patent, or is ultimately rejected. Separate patent applications must be filed in every country in which patent rights are sought, though there are international treaties that facilitate these separate filings and preserve early priority filing dates.there can be a significant cost in obtaining patents, particularly if patent rights are sought in multiple countries.

It is important to emphasize that if an invention had been disclosed to the public more than one year before the application for the patent is filed, a patent cannot issue. Cannabis producers must therefore ensure that disclosures of their innovative work be controlled, including when working with partners. This can typically be handled with the use of appropriate non-disclosure agreements.

The prospect of market exclusivity makes the filing of patent applications a must for cannabis businesses, including those just starting out. For a start-up, simply filing a patent application projects that the company has value and a clear vision of its business. Venture capital often seeks companies with patent applications on file because the applications can mature into assets which can be monetized either by protecting a market for the owner, or through assignment or license to others.

cannabis researchers and producers have already filed hundreds of patent applications in Canada. There are several drawbacks to applying for a patent from the point of view of the applicant. Unlike the case for a trade secret, an applicant for a patent must make full and correct disclosure of the invention and how to use it in the patent itself. This disclosure will allow competitors to understand the applicant’s technology. The public disclosure provides a blueprint for competitors to build upon the patent’s disclosure, and to design around it to avoid infringement. Also, and unlike trade secrets, patents have an expiry date after which the public is free to practice the invention. The Commissioner also has the power to issue compulsory licenses to third parties in several circumstances, including when the demand for the patented article is not being met on reasonable terms. Further, the patent right is not infringed when the patented invention is used for non-commercial or experimental purpose. Finally, there can be a significant cost in obtaining patents, particularly if patent rights are sought in multiple countries.

Disadvantages or not, cannabis researchers and producers have already filed hundreds of patent applications in Canada. These applications relate to a wide range of inventions in the cannabis field including new cannabis resins and oils, methods of producing cannabis having improved properties, specific new growing processes, new harvesting methods, new extraction techniques, new formulations for human and veterinary use as foods, medicines and supplements, new delivery devices, new purification methods, new analytical methods, and new stabilization methods. Interested companies can access these disclosures from the public record.

As cannabis companies rush to obtain patent monopolies for their technologies, minefields are created for operating companies. Cannabis producers should obtain reports on what patent applications exist and might be asserted against their operations if and when these applications mature to issuance. With that intelligence in hand, the cannabis producer can understand what threats can be safely ignored and what patents must be addressed by assignment or license, by ‘design around’ or by developing an argument as to why the patent is invalid and thus unenforceable.


Editor’s Note: In Part 3 of this series, which will be published next week, Naiberg will discuss plant breeders’ rights and protecting new plant varieties. Stay tuned for more!

Ellice Ogle headshot

Concentrate On a Food Safety Culture In Your Workplace

By Ellice Ogle
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Ellice Ogle headshot

In A Culture of Food Safety: A Position Paper (2018)the Global Food Safety Initiative (GFSI) defines food safety culture as the “shared values, beliefs, and norms that affect mind-set and behavior toward food safety in, across, and throughout an organization.” In other words, food safety culture in your workplace is the “this is how we do things around here.”

A food safety culture needs to be relentlessly communicated – everyone needs to know it is his or her job, not just a dusty slogan on the wall or a whisper down the halls.Building a strong food safety culture is particularly relevant to the cannabis workplace because of the unique history of the workers and the unique needs of the consumers. The cannabis industry is special in that it was an industry before it became regulated. As such, there are many workers in the industry who have a deep passion for cannabis products, but with experience rooted in working within only a few official standards. Thus, the behavior and mind-set of workers in the cannabis industry must adjust to new regulations. However, even currently, standards are ever changing and vary from state to state; this causes further confusion and inconsistency for you and your workers. On top of that, now that cannabis is legalized in certain pockets, cannabis reaches a larger, wider audience. This population includes consumers most vulnerable to foodborne illness such as people with immunocompromised systems, the elderly, the pregnant or the young. These consumers in particular need and deserve access to safe cannabis products every experience. Therefore, it is that much more important to develop a strong food safety culture in the workplace to promote safe, quality cannabis large-scale production for the larger, wider audience.

To achieve a food safety culture, GFSI emphasizes the vision and mission of the business, the role of the leaders in the organization, and the continuity of communication and training. GFSI also emphasizes that these components are interrelated and all are needed to strengthen a food safety culture. Food safety culture components can be simplified into: 1) things you believe, 2) things you say, and 3) things you do.“this is how we do things around here.”

Things You Believe

Food safety culture starts from the top, with the executive team and senior managers. It is this group that dictates the vision and mission of the business and decides to include food safety and quality as a part of this guiding star. Moreover, it is this group that commits to the support for food safety by investing the time, money and resources. The message then has to spread from the executive team and senior managers to an interdepartmental team within the workplace. That way, the values of food safety can be further shared to front-line workers during onboarding and/or continuous training. To restart a food safety culture, a town hall can be a useful tool to discuss priorities in the workplace. Overall, it is important to have every worker believe in producing safe food and that every worker is a part of and has ownership of contributing to the food safety culture at your workplace (GFSI, 2018).

Things You Say

A food safety culture needs to be relentlessly communicated – everyone needs to know it is his or her job, not just a dusty slogan on the wall or a whisper down the halls. The Food and Drug Administration (FDA) has a saying that “if it’s not written down, it didn’t happen.” Thus, the guidelines for a food safety culture need to be embedded in the policies, programs and procedures; and these guidelines need to be a part of training from day one and supplemented with periodic reminders. For effectiveness, make the communication engaging, relevant and simple – use your workers to pose for posters, use digital tools such as memes. In his presentation at the 2015 Food Safety Consortium, Frank Yiannas, vice president of food safety at Walmart, says “How many of you created training videos that you show the desired behavior once? You should probably show the behavior more than once and by a few different employees so that when they see it, they see multiple people in the video doing it and that’s the social norm.” By sending a consistent message, a food safety culture can flourish in your workplace.A food safety culture does not happen once; a food safety culture is a long-term commitment with continuous improvement.

Things You Do

A food safety culture does not happen once; a food safety culture is a long-term commitment with continuous improvement. Periodic evaluation of food safety metrics and alignment with business goals contribute to maintaining a food safety culture – it is useful to learn from successes as well as mistakes. In the same presentation mentioned above, Yiannas discusses “Learning from the wrong way [mistakes] lessens the likelihood that we will become complacent” where he defines complacency as “a feeling of quiet security, often while unaware of some potential danger or defect that lurks ahead.” Without the constant commitment, businesses can falter in their food safety and cause costly mistakes – whether that be recalls or illnesses or worse. By not becoming complacent and emphasizing constant accountability, a food safety culture can thrive at your workplace and make your workplace thrive.

With the regulated cannabis industry still in its infancy, the time is now for every cannabis workplace to instill a food safety culture. Before being mandated, the cannabis industry can rally for food safety because it is the right thing to do. With participation from each workplace, the industry as a whole can be united in producing safe product and be better positioned to change stigmas.

emerald test retail

The Emerald Test Gets Record Lab Participation

By Aaron G. Biros
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emerald test retail

According to a press release released by Emerald Scientific, their spring Emerald Test had a 25% increase in participation over the fall 2017 test.

77 laboratories from 18 states and two foreign countries participated in the bi-annual Emerald Test, an inter-laboratory comparison and proficiency testing (PT) program. The program is a tool for labs to demonstrate their competence to existing clients, potential customers, regulatory agencies and accreditation bodies.

Overall, the company shipped 314 PT samples, with the majority in a hemp or hemp oil matrix. According to the press release, the new PTs including potency in hemp oil, STEC, Aspergillus Mold and Mycotoxins attracted a good deal of labs. “Many laboratories have been regular participants which speaks volumes about their commitment to quality assurance, regulatory compliance, and consumer safety,” says Ken Groggel, director of Emerald Scientific’s proficiency testing program. “The collegial attitude of open communication and shared experience increases our knowledge and ensures continued success for all involved. Our goal is to establish an industry benchmark for cannabis testing while providing valuable feedback to each laboratory’s quality assurance system.”

This marks the first time the Emerald Test used two potency PTs- the original in solution and a new hemp oil matrix. “Of the 62 labs that participated in the Potency PT, 48 took the PT in solution with 47 receiving an Emerald Badge,” reads the press release. “Another 23 labs took the PT in hemp oil, with 22 awarded an Emerald Badge. Nine labs took both PTs.”

39 labs took PTs in APC, Total Coliform, E. coli, Enterobacteriaceae and Yeast/Mold and 38 of those received the badge. 45 reported results for Salmonella and 42 of them were able to correctly identify the contaminated sample. 12 labs took the Aspergillus Mold PT and 11 of them were awarded the badge. 24 participated in the pesticides PT and 19 of them met criteria for the badge, while four of them did not report results.

The press release noted that the pesticides and residual solvents in hemp oil PTs were some of the more challenging tests in the spring program. 43 labs reported results for the residual solvents in hemp oil PT and only 31 received badges. The terpenes in hemp oil PT was also a challenging test where 21 labs participated and only 11 received the badge, marking the lowest passing rate of all the PTs.

The advisory panel for The Emerald Test consists of chemists, accreditation providers, laboratory owners, and other industry experts to keep it representative of industry needs. “The Emerald Test is the most comprehensive testing program in the world for the cannabis industry, but as the market grows more testing will be needed,” says Groggel. “We intend to continue introducing new proficiency tests while expanding the menu of matrix choices in response to laboratory requests and regulatory requirements.”

According to the press release, their fall program is open for enrollment until today. Testing begins in mid-October.

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The Battle Over CBD Regulation Hits Europe

By Marguerite Arnold
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With all the attention on the pending regs for the recreational industry in Canada plus the huge medical market under construction in the EU, it is easy to forget the other cannabis discussion in the room right now. Namely CBD in commercial food ingredients and supplements. Battles in the beauty space, while surfacing, are still much less avidly fought.

As a result, edible CBD is also rapidly becoming (another) big green elephant in the room. Globally. Starting with all the changing rules about mostly medical use of cannabinoids in general.

This is underway, sort of, in the United States, driven by state regulations and consumer protection initiatives, but delayed on a federal level by the fact that CBD is still scheduled, like THC, as a Schedule I drug.

In Europe, however, this is already a different animal.

The regulatory hammer also appears to be coming down in strategic country markets, with strange hybrid fights and issues emerging as a result.

For example, as cannabis crops (designed for both markets) begin to flourish in Spain buoyed by both the clubs in Barcelona and the growth of legitimate medical and other kinds of cannabis cultivation across the country – and much of that for export, authorities are cracking down on a federal level about labelling of not cannabis bound for clubs, but the CBD used in edibles.

In the last month, CBD industry blogs are reporting that the Spanish government is sending both warning letters to distributors and the police are apparently taking products off of shelves directly.

For all the direct showdowns about the cannabis plant this year, not to mention CBD, including British children ending up in hospital, this has got to make the top five list.

A Brief Modern History Of CBD Controversies On The Continent

The current complications have their roots in both the regulation of medical cannabis, health supplements and what are called “novelty” food items.

The food issue has been cooking for several years and for botanicals and additives far from cannabidiol. This year, on January 1, however, the entire EU brought in a new directive about the use of certain plants in food which seems to be affecting the edible cannabis conversation all over the continent. That said, countries are interpreting the same at different speeds and with different enthusiasm.

The EU looks poised to hop on the legalization train

Switzerland (not a member of the EU) is actually the only country on the European continent where so far, things have gone relatively smoothly. Their lack of EU membership is actually why. This also does not mean they have overcome some of the larger problems inherent in this entire discussion, but, if things go to form, it will be relatively drama free.

That is not the case in other places.

For example, at the end of 2016, British authorities made a splash about medical labelling with the Medicine and Health Care products Regulatory Agency (MHRA) also leaving the entire edibles discussion in limbo. Technically, low strength CBD can be sold in the UK but it must be labelled as a food product if not specifically made for the medical market. That flap is likely to take off again with the direct competition now of not only Tilray but Namaste and the changing scheduling of cannabis in the UK to a Schedule II in October. See the recent furore over the “unauthorized claims” supposedly made by the nascent Cannabis Trades Association in meeting, lobbying if not “working” with local authorities. The organization has literally blossomed within the last 18 months to over 300 members and 1,200 sellers in part to figure out what exactly the rules are, as authorities grapple with changing times.

tilray-logoNow jump the channel to Spain. The international focus of late has not been just the medical cannabis now sprouting in greenhouses owned by established pharmaceutical companies, or that bound for semi medical use in Barcelona, but the entire CBD edibles discussion.

Why?

On some levels, it is clearly an attempt to continue to set less than grey rules for the Spanish cannabis industry, which even in the club scene is regulating. But beyond that, this fight is altogether more complicated, and far from just regional, or even just a Spanish conversation.

European Food Regulation Meets The Cannabis Industry

CBD in edible products will, according to European regulation, make it a novel food or “additive” – namely that products containing the cannabinoid have not been used “safely”. Translated into English that crosses cultural boundaries, this definition really means that the substance in question must have been part of a regulated federal procedure – for at least 25 years in any third country. As such, it will have to be tested and regulated accordingly.In other words, until the EU can move to classify CBD as a novel food, in Spain, CBD products on the market must be labelled “external use only.”

One does not have to be an industry analyst to know this clearly excludes all parts of the cannabis plant. Everywhere. This is why the situation now unfolding in Spain is all the more worrying for the industry across Europe.

In Spain at least, the crackdown appears to be on any food item containing cannabis, which, according to European-wide regulations, has yet to be classified as a “novel food.” Namely, a food product which has not been consumed in a significant degree in the EU before May 15, 1987. See the guide for new applicants here.

In other words, until the EU can move to classify CBD as a novel food, in Spain, CBD products on the market must be labelled “external use only.”

Where Does This Leave The CBD Industry Across Europe?

As any manufacturer or vendor in any EU country could technically be required to register their new food, this means that cannabis producers and distributors in Europe need to be on their toes for the next several years as the regulatory schemata is worked out. Bottom line? Expect as much hullabaloo over this sector of the market as other places (even if over other issues).Both producers and distributors could easily face labelling problems

Here is the critical take-away. Regulation is coming to the entire industry in Europe in a way unseen in both Canada and the U.S. and from a much more granular perspective.

What “reigns in Spain” in other words right now, is a wake-up call for CBD producers across the continent, even if not involved in the medical space. Not to mention both U.S. and Canadian producers (in particular) looking for profitable market entry strategies. Labelling and standards, in other words, are clearly on the way, and beyond the drawing board, for all cannabinoids, not just those of the “medical” kind.

In the meantime, edible CBD products in Europe and in every country are ripe for the institution of new guidelines that are, as yet, formalized. Both producers and distributors, therefore, could easily face labelling problems for all their CBD products and product lines for the next several years.

Massachusetts Regulators Crack Down On Pesticide Use

By Aaron G. Biros
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Earlier this month, the Massachusetts Department of Health sent a cease-and-desist letter to Good Chemistry, a Colorado-based brand operating in Massachusetts with a dispensary in Worcester and a cultivation facility in Bellingham. The letter claimed Good Chemistry used unapproved pesticides and must close their operations in the state.

goodchem.exter
A Good Chemistry dispensary in Colorado

According to a Boston Globe article, the company used three pesticides (approved for use on organic food products by the federal government) that cannabis regulators in Nevada, Oregon, Washington and Colorado have all approved for use in cannabis cultivation. Previously, Massachusetts has allowed a number of pesticides to be used on cannabis, but since last year when the state’s Department of Agricultural Resources took over regulating pesticide use on cannabis, they decided to ban all pesticides.

Representatives from Good Chemistry insist the compounds used were safe and that the state is singling them out when the practice is widespread in the industry. “These organic compounds are safe all over the country, and they’re safe in Massachusetts,” Jim Smith, a lawyer for Good Chemistry, tells the Boston Globe. “For the state to single out Good Chemistry for using an industry-standard practice is absolutely wrong. It’s not acceptable — and we’re not going to destroy the crop, because it poses no risk to public safety whatsoever.”

Matthew Huron, CEO of Good Chemistry
Matthew Huron, CEO of Good Chemistry

Good Chemistry even disclosed to the state that they would use those pesticides when they applied for a cannabis business license. According to Telegram.com, a local Worcester publication, Matthew Huron, chief executive officer of Good Chemistry, is asking the state to reverse their decision. “The Department of Public Health has the discretion to amend or rescind their order to allow us to make the cannabis we’ve cultivated available to patients in the Worcester community,” says Huron. “Patients have let us know that they really benefited from Good Chemistry’s wide selection of high quality cannabis strains, and they would like access to it again as soon as possible. We’ve asked the state to incorporate the research, analysis and experience that led other states like Colorado, Nevada, Washington and Oregon to determine that the use of these cultivation methods are best practices and helps create healthier, contaminant-free cannabis for patients and the industry as a whole.”

On September 5, the Department of Public Health allowed Good Chemistry to amend the cease-and-desist so they could sell products from other producers in the state. “Many of our patients rely on our medicine we grow specifically and we now are only allowed to sell third party product,” Huron told Telegram.com.

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Tilray Enters Both U.S. & UK Markets

By Marguerite Arnold
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Tilray has long been seen as one of the market leaders in the global cannabis space. They are strategically placed in several critical areas to continue to do well, and put up major competition for just about everyone else (including German market entry first Canopy, plus the other big players in both Canada and Europe) ever since. See Aurora, Maricann and Aphria, to name a few. On the EU front, they are also certainly giving Dutch Bedrocan (with not only existing government contracts, but a newly increased ex-im medical allowance across the open Schengen border) a run for its money. And appear to have broached a monopoly long held by GW Pharma in the UK. 

But first things first. Here is a brief list of accomplishments on the corporate CV so far.In the U.S., Tilray just scored a medical trial at the University of San Diego with a pill used to treat a nerve disorder.

Long (relatively speaking) before Europe was on the map for anyone but a couple of Canadian LPs, the company was exporting to Croatia (in 2016). Even the initial hiccups in delivery (a batch arrived in broken bottles), did not stop their foreign expansion plans. 

When the first German cultivation bid was due, the company also, at least according to their spokesperson in Berlin at the time, considered applying. However, by late summer last year, Tilray was actually the first to publicly tip their hands that not only were they bowing out of the German tender, but had rather decided to import to Germany from cheaper EU climes. See their production facilities in Portugal. Plus of course a mass distribution deal to German pharmacies via local distribution.

Then there is their social media presence on Leafly, which also competes with Weedmaps as both an information portal and dispensary finder in key markets (California and Canada). The German version of the website (Leafly.de), has created a reality, no matter where the server is located, of also connecting directly to patients in a market still finding its way. 

tilray-logoAdd all these elements together, and that puts the company behind it all in an unbelievably strong position to continue to gain both market access and market growth in multiple jurisdictions while carefully moving at literally the change if not bleeding edge of the law.

How much long term impact this will have, however remains to be seen. Why? The times are changing fast. And not everyone is following a policy of promotion timed around other large events (see Canadian recreational legalization and the timing of the company’s IPO). 

Here is another example: the company’s most touted recent double victory, on each side of the Atlantic. Why? This is a place where cannabis companies are starting to compete. And while notable, particularly in it’s timing, is clearly indicative of the next stage in the development of the legitimate medical cannabis industry– not just Tilray.

Trials As Market Entry Tools

Medical trials in both the United States and Europe right now (including the UK for now at least), are the best way for cannabis companies to enter and gain market share. In the U.S., Tilray just scored a medical trial at the University of San Diego with a pill used to treat a nerve disorder.

Last week, Tilray also announced that they had essentially become the first Canadian LP to successfully challenge GW Pharmaceuticals on its home turf in the UK, even if for now limited to one patient application at a time. That won’t last, nor will such a tight monopoly.From a medical point of view, it is a very positive sign, at least for now.

That cross-Atlantic connection is even more interesting, however, given U.S. market entry recently for GW Pharmaceutical’s product, Epidiolex. 

From a medical point of view, it is a very positive sign, at least for now. How it will end up in the future is anyone’s guess, including stock valuation. 

Most advocates, of course, still hope for a medical market where patients are not restricted from deciding between the whole plant, oils or even the pharmaceutical products they choose to take.

Tilray of course is also not the only large LP engaged in medical trials. They are going on all over Europe right now (even if not as well strategically publicized). Health Canada is also committing to trials in Canada over the next five years.

However, what this very clearly demonstrates is that the global medical market is now ripe pickings for companies who approach the entire discussion from a “pharmacized” product point of view. Even if that means in Europe, and including for Tilray, entering the German and other medical markets with flower, oils and medical products.