Tag Archives: risk

Steven Burton

Standardization: A Guide Through the Minefield

By Steven Burton
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Steven Burton

Now that cannabis edibles have been legalized nationally in Canada, many existing and aspiring license holders have been surprised to discover that they must comply with food safety regulations. This became crystal clear when Health Canada published their Good Production Practices Guide For Cannabis in August 2019.

With this development, it should be obvious to everyone that Good Manufacturing Practices (GMP) certifications are simply not enough.

Hazard Analysis and Critical Control Point (HACCP) based preventative control programs are now the absolute minimum and higher levels of certification (GFSI) should be on everyone’s wish list.

HACCP is a methodology that is all about identifying biological, chemical and physical hazards and determining how they will be controlled to mitigate the risk of injury to humans. Recently, bio-terrorism and food fraud hazards have been added to the list and it is a good idea to address quality hazards as well.

The process of developing a HACCP program involves identifying these hazards with respect to ingredients, materials, packaging, processes and cross-contamination points (explicitly required in Canada only). However, it is a specific ingredient hazard that I’d like to talk about here.

HACCPAs this market has emerged, I’ve met with many cannabis companies as the onerous levels of knowledge and effort required to build and maintain an effective HACCP program manually has dawned upon the industry. Many are looking for technological solutions to quickly solve this problem. During these discussions, a curious fact has emerged that set off the food safety alarm klaxons around here.

Most people alive today are too young to remember this but, with few exceptions, the standardization of ingredients is a relatively modern phenomenon. It used to be that the fat content of your milk varied from season to season and cow to cow. Over time, the food industry standardized so that, amazingly, you can now choose between milks with either 1% or 2% fat, a level of precision that would border on miraculous to someone born in the early 20th century.

The standardization of ingredients is important in terms of both quality and safety. Take alcohol for example. We know that a shot of spirits generally contains 40% alcohol. Different products may vary from this standard but, if I pour a shot of my favourite Bowmore No.1 single malt in Canada or Tasmania, this year or 10 years from now, I can expect a consistent effect from the 40% alcohol content of the quantity I’ve imbibed.

Imagine a world in which this was not the case, where one shot would be 40% but the next might be 80%. Things could get out of control quite easily at the 80% level so, to avoid this, distillers monitor and blend their product to ensure they achieve the 40% target, which is called the “standardization marker”.

With respect to cannabis, the obvious standardization marker is THC. During the manufacturing process, edibles manufacturers do not normally add cannabis flower directly into their products but instead add a THC concentrate produced during previous production steps. However, we’ve found that the wisdom of standardizing these concentrates has not yet dawned upon many in the industry, which is alarming at best and dangerous at worst.

The reason for this is that, since cannabis is inherently a heterogeneous plant, one cannot precisely achieve a particular marker value so the outcome of the concentration process is variable. The food industry long ago overcame this problem by blending or diluting to achieve a consistent marker concentration, but the cannabis industry has not yet adopted this advance.

The cannabis edibles industry is still immature and it will take time to bring all the necessary risk mitigation processes into place but one excellent place to start is to seriously consider standardizing concentrates to a THC marker.Instead, manufacturers simply keep track of the strength of each batch of concentrate and then adjust the quantity added to their recipes to achieve the desired THC content. This seems logical on the surface but presents a serious risk from the HACCP perspective, namely a chemical hazard, “Excessive psychoactive compound concentrations due to human error at levels that may be injurious to human health”.

The reality is that workers make mistakes, which is why it is imperative to mitigate the risk of human error insomuch as possible. One of the best ways to do this is to standardize to avoid the scenario where a worker, faced with a row of identical containers that are differentiated only by a tiny bit of text, accidentally grabs the wrong bottle. The error isn’t caught until the product has been shipped, consumed, and reports of hospital visits start coming in after the authorities trace the problem back to you. You must bear the costs of the recall, your reputation has been decimated and your company is floundering on the financial rocks.

US-based Drip More, LP recently found this out the hard way after consumers complained that their product tasted bad, bitter and/or harsh. An investigation determined that excessive nicotine content was the source of the problem and a voluntary recall was initiated. Affected product that had already been sold in 26 states. The costs of this recall have not been tallied but they will be staggering.

The cannabis edibles industry is still immature and it will take time to bring all the necessary risk mitigation processes into place but one excellent place to start is to seriously consider standardizing concentrates to a THC marker. This strategy is cheap, easy and you’ll never be sorry.

Aphria, Inc. Implements Quality Management Systems

By Cannabis Industry Journal Staff
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According to a press release published today, Aphria Inc. has implemented Rootstock Software’s cloud Enterprise Resource Planning (ERP) solutions and ComplianceQuest’s Enterprise Quality Management System (EQMS). Aphria, one of the largest cannabis companies in the world, trades on both the Toronto Stock Exchange and the New York Stock Exchange.

Rootstock’s cloud ERP software includes things like order processing, production management, supply chain management, lot and serial number trackability and traceability, compliance reporting, costing and financial management. ComplianceQuest’s EQMS software provides support for GMP compliance and can help improve efficiencies in operations. The EQMS focuses on quality and risk management across Aphria’s business platforms, from sourcing to manufacturing to supply chain management.

Aphria is using the entire EQMS platform, which includes software to handle documents, training, changes, inspections, nonconformance, corrective actions (CAPA) and customer complaints which integrates to Rootstock’s ERP. According to the press release, the company is currently working to roll-out audit, equipment, incident and supplier management functions and will be fully live with the entire quality system in the next few months.

According to Tim Purdie, chief information officer & chief information security officer of Aphria Inc., both platforms delivered on their implementation. “Grounded in the scalability of the force.com platform, CQ transformed our quality management operating capabilities overnight and we are delighted at the fully integrated partnership result,” says Purdie. “We now have fully digital real-time informatics and ability to implement change in a highly transparent manner to meet the demands of our high growth business.”

Adding that Rootstock ERP will help facilitate their company’s production, inventory and supply chain management, Purdie says both platforms will enable Aphria to be increasingly responsive to market needs. “Aphria is setting the standard as a worldwide leader in the cannabis industry through a diversified approach to innovation, corporate citizenship, strategic partnerships and global expansion,” Purdie says. “With these system implementations, we’re now technologically equipped to take our competitive advantage to new levels of market leadership.”

Soapbox

Cannabis Growers and Distributors: Your Cyber Risk is Growing Like Weeds

By Emily Selck
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Cannabis growers and distributors are “green” when it comes to cyber security. Unaware of the real risks, cannabis businesses consistently fall short of instituting some of the most basic cybersecurity protections, leaving them increasingly vulnerable to a cyber-attack.

Cannabis businesses are especially attractive to hackers because of the vast amount of personally identifiable and protected health information they’re required to collect as well as the crop trade secrets they store. With businesses growing by leaps and bounds, and more and more Americans and Canadians purchasing cannabis, cybercriminals are likely to increase their attacks on the North American market in the coming year. Arm your cannabis business with the following best practices for growers and distributors.

Distributor Risk = A Customer’s PII

Cyber risk is the greatest for cannabis distributors, required to collect personal identifiable information (PII), including driver’s licenses, credit cards, medical history and insurance information from patients. State regulatory oversight further compounds the distributor’s risk of cyber-attack. If you’re a cannabis distributor, you’ll want to make sure to:

  • Know where you retain buyer information, and understand how it can potentially be breached. Are you scanning driver’s licenses into a database, or retaining paper files? Are you keeping them in a secure area off site, or on a protected network? Make sure a member of your management team is maintaining compliance with HIPAA and state statutes and requirements for cannabis distribution.
  • Institute strong employee oversight rules. Every employee does not have to have access to every sale, or your entire database of proprietary customer information. Delegate jobs behind the sales desk. Give each employee the access they need to do their job – and that’s it.
  • Distributors have to protect grower’s R&D information too. Most cannabis distributors have access to their grower’s proprietary R&D information so they can help customers understand which products are best for different medical symptoms/needs. Make sure your employees don’t reveal too much to put your suppliers in potential risk of cyberattack.

Grower Risk = Crop Trade Secrets

For cannabis growers, the risk is specific to crop trade secrets, research and development (R&D). If you’re a cannabis grower, you’ll want to:

  • Secure your R&D process. If you’ve created a cannabis formula that reduces anxiety or pain or boosts energy, these “recipes” are your competitive advantage – your intellectual property. Consider the way you store information behind the R&D of your cannabis crops. Do you store it on electronic file, or a computer desktop? What type of credentials do people need to access it? Other industries will use a third party cloud service to store their R&D information, but with cannabis businesses that’s typically not the case. Instead, many growers maintain their own servers because they feel this risk is so great, and because their business is growing so fast, there are not yet on the cloud.
  • Limit the number of people with access to your “secret sauce.” When workers are harvesting crop, or you’re renting land from farmers and planting on it, make sure to keep proprietary information in the hands of just the few who need it – and no one else. This is especially important when sharing details with third party vendors.

Cyber coverage is now ripe for picking

Although cannabis businesses are hard to insure – for just about every type of risk – cyber insurance options for cannabis companies have recently expanded, and come down in price. If you’ve looked for cyber coverage in the past and were previously unable to secure it, now is the time to revisit the market.

Know that cyber policy underwriters will do additional due diligence, going beyond the typical policy application, and ask about the types of proprietary information you collect from customers, as well as how you store and access it at a later date. Have this knowledge at your fingertips, and be ready to talk to underwriters about it when you’re bidding for a new policy – and at renewal time.

The Best Way to Remediate Moldy Cannabis is No Remediation at All

By Ingo Mueller
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Consumers are largely unaware that most commercial cannabis grown today undergoes some form of decontamination to treat the industry’s growing problem of mold, yeast and other microbial pathogens. As more cannabis brands fail regulatory testing for contaminants, businesses are increasingly turning to radiation, ozone gas, hydrogen peroxide or other damaging remediation methods to ensure compliance and avoid product recalls. It has made cannabis cultivation and extraction more challenging and more expensive than ever, not to mention inflaming the industry’s ongoing supply problem.

The problem is only going to get worse as states like Nevada and California are beginning to implement more regulations including even tougher microbial contamination limits. The technological and economic burdens are becoming too much for some cultivators, driving some of them out of business. It’s also putting an even greater strain on them to meet product demand.

It’s critical that the industry establishes new product standards to reassure consumers that the cannabis products they buy are safe. But it is even more critical that the industry look beyond traditional agricultural remediation methods to solve the microbial problems.

Compounding Risks

Mold and other microbial pathogens are found everywhere in the environment, including the air, food and water that people consume. While there is no consensus yet on the health consequences of consuming these contaminants through cannabis, risks are certainly emerging. According to a 2015 study by the Cannabis Safety Institutei, molds are generally harmless in the environment, but some may present a health threat when inhaled, particularly to immunocompromised individuals. Mycotoxins resulting from molds such as Aspergillus can cause illnesses such as allergic bronchopulmonary aspergillosis. Even when killed with treatment, the dead pathogens could trigger allergies or asthma.

Photo credit: Steep Hill- a petri dish of mold growth from tested cannabis

There is an abundance of pathogens that can affect cannabis cultivation, but the most common types are Botrytis (bud rot, sometimes called gray mold) and Powdery Mildew. They are also among the most devastating blights to cannabis crops. Numerous chemical controls are available to help prevent or stem an outbreak, ranging from fungicides and horticultural oils to bicarbonates and biological controls. While these controls may save an otherwise doomed crop, they introduce their own potential health risks through the overexposure and consumption of chemical residues.

The issue is further compounded by the fact that the states in which cannabis is legal can’t agree on which microbial pathogens to test for, nor how to test. Colorado, for instance, requires only three pathogen tests (for salmonella, E. coli, and mycotoxins from mold), while Massachusetts has exceedingly strict testing regulations for clean products. Massachusetts-based testing lab, ProVerde Laboratories, reports that approximately 30% of the cannabis flowers it tests have some kind of mold or yeast contamination.

If a cannabis product fails required microbial testing and can’t be remedied in a compliant way, the grower will inevitably experience a severe – and potentially crippling – financial hit to a lost crop. Willow Industries, a microbial remediation company, says that cannabis microbial contamination is projected to be a $3 billion problem by 2020ii.

Remediation Falls Short
With the financial stakes so high, the cannabis industry has taken cues from the food industry and adopted a variety of ways to remediate cannabis harvests contaminated with pathogens. Ketch DeGabrielle of Qloris Consulting spent two years studying cannabis microbial remediation methods and summarized their pros and consiii.

He found that some common sterilization approaches like autoclaves, steam and dry heat are impractical for cannabis due the decarboxylation and harsh damage they inflict on the product. Some growers spray or immerse cannabis flowers in hydrogen peroxide, but the resulting moisture can actually cause more spores to germinate, while the chemical reduces the terpene content in the flowers.

Powdery mildew starts with white/grey spots seen on the upper leaves surface

The more favored, technologically advanced remediation approaches include ozone or similar gas treatment, which is relatively inexpensive and treats the entire plant. However, it’s difficult to gas products on a large scale, and gas results in terpene loss. Microwaves can kill pathogens effectively through cellular rupture, but can burn the product. Ionizing radiation kills microbial life by destroying their DNA, but the process can create carcinogenic chemical compounds and harmful free radicals. Radio frequency (which DeGabrielle considers the best method) effectively kills yeast and mold by oscillating the water in them, but it can result in moisture and terpene loss.

The bottom line: no remediation method is perfect. Prevention of microbial contamination is a better approach. But all three conventional approaches to cannabis cultivation – outdoors, greenhouses and indoor grow operations – make it extremely difficult to control contamination. Mold spores can easily gain a foothold both indoors and out through air, water, food and human contact, quickly spreading into an epidemic.

The industry needs to establish new quality standards for product purity and employ new growing practices to meet them. Advanced technologies can help create near perfect growing ecosystems and microclimates for growing cannabis free of mold contamination. Internet of Things sensors combined with AI-driven robotics and automation can dramatically reduce human intervention in the growing process, along with human-induced contamination. Natural sunlight supplemented with new lighting technologies that provide near full-light and UV spectrum can stimulate robust growth more resistant to disease. Computational fluid dynamic models can help growers achieve optimal temperature, humidity, velocity, filtration and sanitation of air flow. And tissue culture micropropagation of plant stock can eliminate virus and pathogen threats, to name just a few of the latest innovations.

Growing legal cannabis today is a risky business that can cost growers millions of dollars if pathogens contaminate a crop. Remediation methods to remove microbial contamination may work to varying degrees, but they introduce another set of problems that can impact consumer health and comprise product quality.


References

i. Holmes M, Vyas JM, Steinbach W, McPartland J. 2015. Microbiological Safety Testing of Cannabis. Cannabis Safety Institute. http://cannabissafetyinstitute.org/wp-content/uploads/2015/06/Microbiological-Safety-Testing-of-Cannabis.pdf

ii. Jill Ellsworth, June 2019, Eliminating Microbials in Marijuana, Willow Industries, https://willowindustries.com/eliminating-microbials-in-marijuana/#

iii. Ketch DeGabrielle, April 2018, Largest U.S. Cannabis Farm Shares Two Years of Mold Remediation Research, Analytical Cannabis, https://www.analyticalcannabis.com/articles/largest-us-cannabis-farm-shares-two-years-of-mold-remediation-research-299842

 

When You Don’t Know What You Don’t Know: Debunking Cannabis Insurance Myths

By , T.J. Frost
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For all of today’s growing acceptance and legitimacy with cannabis, the reality is that today’s operators – whether growers/producers or dispensary operators – still face risks in running their businesses. If, in the old days, a customer got deathly ill from cannabis contaminated with something from somewhere during the distribution chain, oh, well. But now that there’s a legal system of checks and balances; there’s recourse when issues arise.

The problem is that the business is so new that most people don’t know what they don’t know about mitigating those risks. And that, unfortunately, extends to many in the insurance business who need to be doing a better job helping put the right protections in place.

One grower bemoaned to me at a cannabis trade show, “I sure wish I could insure my crops.” What? “You can,” I told him. His old-school ag broker didn’t know any better and didn’t do him any favors with his ignorance. But it brought home the point: We have to start treating cannabis like the real business it is.

Reviewing the existing insurance policies of today’s cannabis businesses uncovers some serious gaps in coverage that could be financially crippling if not downright dangerous should a claim be triggered. Retail dispensaries, for example, are high-cash businesses, making banking and trusted employees a must-have.Today’s cannabis businesses need to understand there will be risks but they are a lot more manageable than in the old days. 

And a close eye must be cast to lease agreements for hidden exposures, too. We know a Washington state grower that had no property insurance on its large, leased indoor growing facility. The company’s lease made its owners, not their landlord, responsible for any required building improvements. It was one of a variety of serious exposures that had to be fixed.

Today’s cannabis businesses need to understand there will be risks but they are a lot more manageable than in the old days. Rather than find themselves under-insured, they can start by learning what they probably have wrong about insurance. Dispelling three of the most common myths is a good place to start.

Myth #1: Nobody will insure a cannabis business.

Not remotely true. You can and should get coverage. Think property and casualty, product liability, EPLI and directors and officers, employee benefits and workers comp. Additionally, you should be educated on what crop coverage does and doesn’t cover. Depending on your business’ role in production and distribution, you might also consider cargo, stock throughput, auto, as noted, crime and cyber coverage. It pays to protect yourself.

Myth #2: If my business isn’t doing edibles, I don’t have to worry about product liability insurance.

The reality is that product liability may be the biggest risk the cannabis industry faces, at every level on the supply chain. There’s a liability “trickle down” effect that starts with production and distribution and sales and goes down to labeling and even how the product is branded. Especially when a product is an edible, inhalable or ingestible with many people behind it, the contractual risk transfer of product liability is an important consideration. That means the liability is pushed to all those who play any role in the supply chain, whether as a producer or a retailer or an extractor. And all your vendors must show their certificates of insurance and adequate coverage amounts. Don’t make the mistake of being so excited about this new product that you don’t check out the vendors you partner with for this protection.

Myth #3: Any loss at my operation will be covered by my landlord’s policy.

As the example I cited early illustrated, that’s unlikely. Moreover, your loss might even cause your landlord’s insurance to be nullified for having rented to a cannabis business. It’s another reason to examine your lease agreement very carefully. You want to comply with your landlord’s requirements. But you also need to be aware of any potential liabilities that may or may not be covered. Incidentally, even if your landlord’s policy offers you some protection, your interests are going to be best served through a separate, stand-alone policy for overall coverage.

These are interesting times for the burgeoning legal cannabis business. Getting smart – fast – about the risks and how to manage them will be important as the industry grows into its potential.

Transporting Cannabis Can Be a Costly Business Risk

By Susan Preston, T.J. Frost
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Did you know that the use of personal vehicles for transporting cannabis products is one of the most frequent claims in the cannabis industry? It surpasses property, product liability and even theft. Businesses are either unaware of the risks involved in using personal vehicles for transporting cannabis, or they aren’t taking them seriously enough.

Considering the strict statutes many states have placed on transporting cannabis should be reason alone to be more diligent. For example, the California Bureau of Cannabis Control’s proposed regulations require cannabis business owners to ensure their drivers have designated permits to transport the product. The state’s current legislation mandates inspections at any licensed premises, and requires employers to provide detailed tracking and schedules on the transport of product. Further, the state prohibits using minors to transport cannabis, and considers it a felony to do so.

Regulatory concerns, combined with the potential liabilities that could come from driver behavior, are keeping insurers from offering auto coverage to the cannabis industry. In fact, just four insurers currently offer the industry auto coverage, with premiums running as high as $17,000 per auto on average. It is important to note that personal auto insurance falls short because it doesn’t cover cargo loss.

Alternatively, because the stakes are so high, many companies are using courier services to transport cannabis product. But cargo insurance is still an issue. Without it, the care, custody and control of someone else’s products, and insurance limits are lacking. Even when the courier has cargo coverage, because they are delivering for multiple companies, the claims payout would have to be split amongst all the customers – likely below the value of your loss.

Consider the following best practices when transporting cannabis:

  • Conduct background checks/review DMV records. Uncovering any potential driver issues prior to hiring is critical. Look for previous DUIs or drug related history. Employees who might use product before getting behind the wheel are a significant danger to other drivers and a major liability to the employer. Even after hiring, be on alert for signs that indicate poor driving performance. Use check-in/check-out processes for all drivers, and conduct regular vehicle walk-arounds to look for scratches, dents or other damage that otherwise might be unreported to the employer.First, and most importantly, assess your risk mitigation options. Then, put processes in place as soon as possible to eliminate risk. 
  • Implement quarterly driver training. Educate employees on proper procedures. While minor fender benders and sideswipe accidents are most common, even these can be costly if not handled properly. Once law enforcement get involved in an accident the car’s transportation of cannabis could become a secondary issue. Teach drivers how to handle accidents while on the scene, including informing law enforcement about the cargo and the employer.
  • Use unmarked vehicles. Drivers carrying a significant amount of product and/or cash are tempting targets for thieves. Company cars used for transporting product should be newer, and have no fleet serial numbers or anything identifying the company.
  • Require increased personal liability limits. If an employee is using their own personal vehicle for business purposes, the business owner should require that person carry more than minimum limits of personal liability.  Ideally, they should have $300,000 or more, at an absolute minimum $100,000.

Get started now

First, and most importantly, assess your risk mitigation options. Then, put processes in place as soon as possible to eliminate risk. Secure the right insurance coverage, and ask your broker/underwriter to provide any additional recommendations to best mitigate your transportation, delivery, and cargo exposures.

To learn more, please visit our website.

Tips for Finding the Perfect Cannabis Packaging Partner for Your Business

By Danielle Antos
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Whether your cannabis business is a start-up in its infancy, or established with a loyal customer following, the product packaging you use is essential to building and maintaining your brand. The packaging is the first thing a potential customer sees, and it creates that critical first impression. While the primary function is to contain, protect, and market your products, your packaging is a reflection of your company to the customer. In many ways, the package is the product. Partnering with a quality plastic packaging manufacturer for your cannabis products will increase your success.

Bottles made of high-density polyethylene (HDPE), low density polyethylene (LDPE), polypropylene (PP), and polyethylene terephthalate (PET) have become widely-accepted packaging options within the cannabis industry. There are many plastic bottle manufacturers, but how do you find the right one? In short, seek a manufacturer who makes quality products that are unlikely to present downstream problems for your company, provides services and options that align with things you feel are important, and wants to build a long-term relationship with you so both of your businesses grow faster through strategic partnership.

What to Look for in a Plastic Bottle Manufacturer

Excess Bottom Flash creates a poor printing surface.

As you search for a packaging partner for your cannabis business, here are a few key things to look for:

Bottles That Visually Support Your Brand

It’s essential to partner with a manufacturer who understands the importance of defect-free plastic bottles. Does everything about your packaging convey a sense of trust for your customers? Defects in plastic bottles typically occur during the manufacturing process.

Excessive Side Taper results in uneven, wrinkled labels.

For instance, excessive side taper on the bottles can result in uneven, wrinkled labels that are hard to read and make your product look unprofessional. If flashing on the bottle bottom is not removed, it creates a poor printing surface and results in a poor brand impression.

Partnering with a manufacturer who understands that plastic bottle defects diminish brand presence and who continually strives to remove defect-producing problems out of their manufacturing process is of utmost importance. This avoids many downstream quality problems and helps to keep the focus on growth and off of damage control.

Bottles That Minimize Risk and Waste

Product recalls or safety concerns can be a result of cloudy bottles or material trapped in the resin that makes the plastic packaging look dirty or contaminated. These situations can erode consumer confidence in your brand or expose the customer to risk.

Foreign material trapped in the resin results in reduced customer confidence.

Sub-par plastic bottles can lead to inefficiencies on your filling lines, lost production time, and product that cannot be sold. These situations lead to reduced profitability and negatively impact your bottom line. It’s never good when filled packaging or product has to be thrown away because problems are identified on the filling line.

Uneven Sealing Surface results in poor closure seal and increased risk of product spoilage or contamination.

Worse yet is when your product reaches the point of sale and the problems are identified at the dispensary or by a consumer. For example, over time, an improper seal between the plastic bottle and cap can cause flower to be excessively dry. In turn, when this flower is dispensed to the consumer it can lead to overfilling to make up for weight loss. And some consumers just don’t like their flower to be too dry, resulting in lost sales. Does the defective product get shipped back or trashed at the point of sale location? In either case, this results in the dilemma of wasted product that can’t be used and extra costs that eat into your profitability. 

Closures That Work With The Bottle

The closures for the bottles are also an important part of your cannabis packaging. Can your packaging partner manufacture and supply plastic closures that assure complete functionality to protect your product? Closures produced by the same manufacturer as the bottles ensures that the closure and bottle function correctly together. A one-stop-shop approach will save you time and money.

The cannabis industry is growing quickly and faces many complex regulatory challenges, including regulations for child-resistant packaging. Many states have their own unique cannabis packaging requirements which must be strictly adhered to. Are their bottle and closure pairings compliant with current regulations and those that are under legislation for the future? 

Customization for Your Brand

Can the cannabis packaging manufacturer customize their products to your exact design and specifications? Your product is unique, and your packaging should reflect that. Make sure your brand stands out with the exact image you want to project. There should be “depth” in your supplier: can they do more than just sell you packaging that already exists?

A Safe Resin Source

Another important aspect of safety is country of origin. Plastic bottles and closures manufactured overseas may have impurities in the resin or colorant that could leach or bleed into your products. They may not have documentation of origin or comply with FDA regulations. Your plastic packaging partner should be able to provide this documentation so you can rest assured that your bottles are manufactured under strict guidelines for the safety of your consumers and that your product won’t be affected.

Commitment to Sustainability

To many consumers, packaging made from recycled materials is important. Does your packaging supplier have a strong commitment to environmental sustainability? There is strong market support for carbon-friendly alternatives. Progressive plastic packaging manufacturers are actively working to provide alternatives to plastics made from fossil fuels and instead, using resins produced from renewable resources (i.e. sugarcane). By partnering with a supplier that provides alternative and recycled materials, you enhance your brand by appealing to a growing segment of environmentally concerned consumers.the best cannabis packaging suppliers understand that consistency in the manufacturing process is essential.

Scalable Growth

As your business grows, can your packaging partner grow with you? It’s important that they are able to keep up with the demand for your product and that their supply chain can match your manufacturing needs. As you add to your product line, are they capable of continuing to offer new and innovative packaging? A manufacturer that has a strong business model for growth will benefit you now and for the future.

A Real Cannabis Packaging Partner

Your cannabis business should develop a true partnership with your packaging supplier. They should invest in your success and care about your business. Businesses depend on one another for continued growth – look for a knowledgeable partner that is responsive, courteous and dependable now and for years to come. The best suppliers realize that there is more to a relationship than just the financial transaction of buying packaging.

Additionally, the best cannabis packaging suppliers understand that consistency in the manufacturing process is essential. Using virtually perfect bottles time after time not only reduces waste but helps build consumers’ trust in your brand. Consistency saves you three precious commodities – time, hassle and money.

Remember, a brand consists of more than just a logo and company name. It identifies who you are, what your company stands for and the integrity of your product. Quality cannabis packaging will reinforce your company standards and attract consumers to your product – consistently defining you as a quality provider with integrity in the marketplace. Improving your bottom line and meeting your company’s financial goals is at stake. Is your cannabis packaging partner going to help you grow?

Clearing Up the Haze Surrounding Cannabis Product Liability Risks

By Susan Preston, T.J. Frost
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When a thriving cultivator purchased additional cannabis from a wholesale grower to meet the 5,000 pounds he was short, he was left holding the bag. A customer complained of a strong sulfur taste, and soon it was discovered that the wholesaler had applied the wrong pesticide concentration, rendering the cannabis unusable. The cultivator had to pull contaminated cannabis product from the shelves, a move that cost the company $3.5 million.

This story is not unique. When running short on product, cannabis businesses will often turn to other suppliers and partners to help them fulfill their orders. Unfortunately, improper vetting and a lack of understanding and compliance with state regulations and other requirements may lead to a loss of product integrity and costly product liabilities. Product liability can include more than just the cannabis itself, such as the equipment – vape cartridges, batteries, and lighters. This can quickly inflate the risk and, of course, the cost of a product liability claim. It is possible to transfer some of these cannabis risks to product liability insurance.

Top Three Product Liability Exposures Facing Cannabis Cultivators and Distributors

Three key areas of product liability exposure face cannabis business owners. It’s important to understand how each will affect your business.

  1. Product contamination.When cannabis is sold in an edible form, business owners could face claims of food poisoning or illness. If the product is smoked, there are exposures to contamination, product mislabeling or misrepresentation, and possible health hazard claims related to long-term exposure to potential contaminants.
  2. First party claims. Claims made in the event of an accident, injury or loss, whether caused by the business owner or someone else, will create another set of exposures, including manufacturing defects, failure to warn users on potential product usage hazards, improper labeling, or any product-related defect such as mold or odor.
  3. Third party claims. Cannabis business owners could be liable for claims stemming from the use of their cannabis product that result in a DUI, property damage, loss of wages, medical expenses and bodily injury.

It is possible to transfer some of these cannabis risks to product liability insurance. While there are multiple lines of product liability insurance, you’ll want to make sure you choose one designed specifically for the cannabis industry. These policies may provide coverage for the following exposures:

  • Product contamination
  • Bodily injury damages
  • Fines and penalties for non-compliance with state regulation
  • Bodily or property injury caused to others by product misuse, or by a third party
  • Manufacturing or product-related defects

While product liability insurance covers a number of cannabis risks, it doesn’t cover them all. Cannabis operations require a variety of coverage – property, crime, general liability, worker’s compensationand crop insurance. Insurance carriers will differ in definitions, policy exclusions and coverage language for each policy.

Because designated cannabis product liability and business operations coverage is fairly new and the marketplace features a wide range of options, make sure to work with a broker who understands the fine print of your policies, and your unique needs. The right broker can provide advice and loss control to help you reduce product liability exposures, make product and risk management recommendations that best mitigate your exposures to prevent loss, and ensure the proper coverage to address potential claims.

Matt Engle
Soapbox

Insurers Must Play Catch-Up to Meet Cannabis Industry Needs

By Matt Engle
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Matt Engle

As the cannabis industry continues to grow, demand for insurance products is also increasing. While insurers have been cautious about entering a market that carries the stigma of a Schedule I drug, the cannabis industry is clamoring for insurance coverage options tailored to meet the needs of key players— distributors, growers, processors and retail dispensaries.

The escalating need for insurance products tailored to these cannabis business sectors has not expedited an increase in coverage offerings. The slow entry of insurance carriers into the cannabis sector can be tied to a reluctance to insure an industry with emerging and often unknown risks. This will begin to change as more information becomes available on what loss ratio trends look like in the cannabis industry.

For now, there is a wait-and-see stance held by insurance carriers. This presents a major concern for cannabis-related businesses that are subject to risk at every stage of the supply chain, with particular exposure for theft, general liability, crop loss, and product liability.some degree of crime and theft coverage is needed for these enterprises to help manage the risks associated with a cash-based business

Theft

For cannabis companies, the use of paper currency is a huge part of their risk exposure. Federal banking regulations have limited these businesses to dealing mostly in cash, which makes them a prime target for crime and fraud. Currently, only one carrier will insure coverage for cash and theft risk, and the policy is limited to $1 million for most risks. This is inadequate coverage since many operators have more than that amount on-site.

In states with legislation legalizing cannabis, the cannabis sector will be able to move away from operating in cash if Congress passes the Secure and Fair Enforcement (SAFE) Banking Act, which would protect financial institutions from liability for federal prosecution that could arise from servicing cannabis-related businesses authorized under state law. Until banking regulations give the cannabis industry the ability to operate as legitimate businesses with the stability and safety that would deter criminal activity, some degree of crime and theft coverage is needed for these enterprises to help manage the risks associated with a cash-based business.

General Liability

Cannabis-related businesses need the same general liability coverage as other businesses to protect their premises and operations from lawsuits involving public contact. However, standard general liability policies—which exclude Schedule I substances from coverage—were not created with cannabis businesses in mind. It is still difficult for these businesses to obtain adequate general liability as a result of the legal uncertainty associated with the industry.

Product Liability

Product liability exposures for cannabis businesses encompass a wide range of areas, including edibles, vaporizers, pesticides, mold/fungus, misrepresentation, label claims, breach of warranty, deceptive practices, and failure to warn.

A major area of exposure concerns accidents resulting from impairment. A cannabis cultivator, processor, distributor, or retailer potentially may be considered liable in the event a product defect results in injury after reasonable use or when label defects fail to warn users that a product may have psychoactive effects.

Another area of risk exposure involves products that contain THC, the psychoactive compound that gives cannabis users a high. As the number of THC-containing products such as edibles and tinctures increases, so does the potential exposure to product liability claims for manufacturers and retailers.

The California Cannabis Track-and-Trace (CCTT) system also has implications for product liability. The CCTT is a statewide system used to record the inventory and movement of cannabis and related products through the commercial supply chain. All state cannabis licensees, including those with licenses for cultivation, manufacturing, retail, distribution, testing labs and microbusinesses, are required to use this system. The product liability impact lies in its capacity to determine responsibility along the supply chain from seed to sale.

For example, if a plastic vape pen explodes, a product liability lawsuit could have repercussions for many touch points across the supply chain beyond the manufacturer of the pen–all of which can be identified through CCTT. Entities that touch cannabis products such as soil suppliers or delivery persons also have product liability risk exposure. Personal injury attorneys can find incident-related parties easily and determine liability. This makes it particularly important to add these parties to the policy as additional insureds to help reduce claims exposure.

Crop Loss

Another area of concern for risk exposure is crop loss. Crop insurance is generally hard to obtain due to the significantly different nature of cannabis crops compared to traditional crops like corn or soybeans.

Fires in Sonoma County devastated cannabis crops in Northern California back in 2017.

An indoor crop insurance policy covers cultivators when there is loss resulting from threats such as fire, theft, and sprinkler leakage. However, crop insurance policies generally do not cover losses resulting from mold, rot, disease, changes in climate, or fertilization issues. Many growers forgo this coverage and instead elect to absorb losses and regrow their crops.

Outdoor crop coverage is generally unavailable, or the cost is prohibitive. Any potential for writing outdoor crop insurance for the cannabis industry essentially disappeared as a result of the recent wildfires in California. These devastating fires highlighted the pressing need for property damage and business interruption coverage for growers and dispensaries and other downstream businesses whose supply was disrupted. This lack of available outdoor crop insurance is one of the more notable gaps in available cannabis business insurance coverage.

While cannabis businesses operating in states that have legalized medical and/or recreational cannabis use have challenges getting adequate insurance coverage, there is some good news on the insurance front for those in California. Last year, California’s insurance commissioner announced approval for carriers to offer insurance coverage specifically to cannabis businesses. The state also approved a cannabis business-owners policy (CannaBOP) program that provides a package policy containing both property and liability coverage for qualifying dispensaries, distributors, manufacturers, processors and storage facilities. Colorado is on the verge of being the second state to approve its version of a CannaBOP program.

While more insurance carriers are beginning to write cannabis coverage, the limited insurance options and policies with restrictive plans currently offered todaydo not meet the needs of the cannabis industry. Insurers must catch up to the coverage requirements of this sector by offering more options tailored to growers, retail dispensaries, processors and distributors with better terms and better pricing.

Soapbox

Third-Party Cannabis Safety Audits & How to Prepare in 7 Steps

By Tyler Williams
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Unlike the food industry, the cannabis industry is still in its infancy. Which means there is not a push from retailers demanding cannabis farmers, extractors or manufacturers to get third-party audits. In fact, most grow operations supply into their own dispensaries. So why should a cannabis farmer, extractor or manufacturer get a third-party audit? Third-party audits are crucial to maintaining product safety and quality by providing a third set of eyes to verify what is working and what is not. Besides regulatory requirements and customers requiring your facility to get a third-party audit, there are numerous other benefits to receiving an audit. Some of these benefits include:

  • Improvement to product safety
  • Improvement to product quality and consistency
  • Meeting regulatory compliance
  • Eliminating potential risks and possible recalls
  • Marketing advantages over competitors who are not audited by a third-party
  • Improvement to consumer confidence and an increase to brand loyalty

How to Prepare for a Third-Party Audit

Working for a certification body, I am in the unique position to see numerous sites go through the certification process. In this position I have seen both extremes: Sites that spend 6-8 months and a lot of resources preparing for an audit, as well as sites that wait until the day before to even look at the audit standard. Unfortunately, the latter is almost always going to fail the audit. Here are seven steps for preparing for your next third-party audit.“By failing to prepare, you are preparing to fail.”– Benjamin Franklin

  1. Start Preparing Early

Think of your third-party audit as a college exam one month away. You could start studying for the exam now and get a real understanding of the material or you could wait until the day before to start your no-sleep, energy drink-fueled, 24-hour cram session. We all know which preparation method will get a better score on the exam. Now let’s apply that same strategy to your third-party audit. Once you have decided what audit is best for your site and have those specific standards in your hand, the clock starts ticking and you should already be preparing for the audit, whether it is one month or six months away.

  1. Get Management Commitment

It is essential to the entire cannabis safety and quality system to have commitment from top down. Without this, the site will not get the resources (people, equipment, money, time, etc.) they need to pass a third-party audit. Management commitment is so important that it is often seen as its own section in most modern audit standards. It is very easy for third-party auditors to identify when there is a lack of management commitment in a site. Therefore, if you don’t get management commitment, then you are already starting off the audit on a bad note.

  1. Create a To-Do-ListGMP

Think of the entire audit checklist or standard as your long to-do list. Some things, like attaining a certificate of analysis (COA) from a supplier, may only need to be done annually. While other things, such as ensuring employees are following Good Manufacturing Practices (GMPs), will need to be done continuously throughout day to day operations. Go through the audit checklist and separate what needs to be done annually, semiannually, quarterly, monthly and continuously throughout day to day operations. This will give you a list with all of the frequencies of each different requirement.

  1. Teamwork“Teamwork makes the dream work, but a vision becomes a nightmare when the leader has a big dream and a bad team.” – John C. Maxwell

The preparation of an audit should never rest on the shoulders of one person. Yet this is something I tend to see too often in both food and cannabis facilities alike. Your site should establish a cannabis safety and quality team of multidiscipline personnel that have an impact on product safety and quality. Once the team is established, various tasks from the to-do-list can be disbursed among all the members of the team. Collaboration is key to successfully preparing for a third-party audit, especially when the timelines are very stringent.

  1. Training

Training is essential to preparing for your third-party audit. This is what closes the gaps between what the safety and quality department have developed and what your front-line employees are applying. All employees should know what part of the audit standard applies to them. Additionally, employees should be trained on interview questions that the auditor might ask them during the audit. Helping them prepare for these types of questions will help ease their nerves and allow them to answer the questions with self-assurance when it comes time to the actual audit.

  1. Conduct Internal Audits

Conducting internal audits is not only a great way to prepare for your third-party audit, it’s a requirement. You should always use the audit checklist to observe your documents and facility to see where there are gaps. If possible, the person or team conducting the internal audit should never review their own work. Additionally, all issues or non-conformances should be noted, evaluated, corrected and closed out.

  1. Third-Party Pre-Assessment or Mock Audit (Optional)

A third-party pre-assessment or mock audit is the closest thing you can get to an actual audit. This is where a company would come in and evaluate your site to the specific standards and give a formal report over any deficiencies found during the assessment and how to fix them. This is a great way to test your preparedness before the actual audit.