Tag Archives: Testing

July 4, 2023

Navigating ISO/IEC 17025: Key Considerations for Cannabis Lab Software

By Montserrat Valdes

In some states, cannabis testing facilities must undergo a third-party audit as a condition for obtaining their license. This may involve obtaining an ISO/IEC 17025 accreditation, which requires an evaluation from a qualified auditor. Alternatively, some laboratories may undergo a voluntary audit in certain regions to showcase their competency.

ISO/IEC 17025 is a widely acknowledged global benchmark for the expertise of testing and calibration laboratories. It establishes guidelines for laboratories to showcase their technical proficiency and ability to produce precise and trustworthy results.

For cannabis testing laboratories, obtaining ISO/IEC 17025 accreditation can offer a significant edge over their rivals. Such accreditation can result in several advantages, such as improved credibility, lower operational expenses, better conformity with local and state regulations and more efficient cross-border trade.

Integrating any standard into a regulated enterprise can be a complex undertaking and ISO/IEC 17025 is no exception. This standard puts a strong emphasis on quality by requiring laboratories to exhibit their impartiality, consistency and proficiency in all aspects of their work. Compliance with ISO/IEC 17025 necessitates timely and secure data retrieval, which is difficult to achieve without an information management system. Therefore, laboratories are increasingly turning to laboratory information management systems (LIMS) to modernize their practices, improve quality and meet ISO/IEC 17025 compliance standards. This article explores the critical factors that laboratory managers and staff should consider when selecting a LIMS that can help them fulfill the demands of ISO/IEC 17025. However, let’s first discuss the sections the ISO/IEC 17025 requirements are classified into.

ISO/IEC 17025 Requirements

The ISO/IEC 17025 requirements are divided into five sections:

General Requirements (Section 4): The fourth section of the ISO/IEC 17025:2017 standard details the general conditions that laboratories must follow. This section is primarily concerned with two critical aspects: impartiality and confidentiality. The impartiality requirement mandates laboratories to remain unbiased and take measures to prevent any potential bias. Similarly, the confidentiality requirement mandates that any information collected or generated during laboratory operations must be treated as private and safeguarded adequately to prevent unauthorized access. In instances where the release of confidential information is necessary by law or contract, the laboratory must communicate such release in an appropriate and timely manner.
Structural Requirements (Section 5): In order to achieve the three key objectives of competence, impartiality, and consistent operations, this section addresses the fundamental organizational requirements of a laboratory. This entails being a legal entity with well-defined management responsibilities and documenting all activities, procedures and methods that fall within the standard’s scope. It highlights the importance of human resources by requiring laboratories to provide individuals with the necessary authority and resources to identify and rectify deviations from procedures, methods and the quality management system.
Resource Requirements (Section 6): This section highlights the crucial role of resources in helping a laboratory achieve its objectives and maintain high standards. The section covers five areas, namely personnel, facility and working environment, equipment, metrological traceability and third-party products and services. To meet the standard’s requirements, personnel must demonstrate competence and impartiality, and lab personnel must record their current training status. Lab staff should also be provided with adequate resources to perform their duties. The facility and working environment should be suitable for generating accurate analytical results, while equipment must be properly calibrated and maintained. Metrological traceability is important to establish the connection between measurement results and a reference. Additionally, it is essential to thoroughly evaluate and approve third-party products and services to ensure their suitability. Clear communication of the requirements to third parties is also necessary in this regard.
Process Requirements (Section 7): This section of the standard outlines 11 essential processes that aim to improve efficiency in laboratory operations. The processes include evaluating requests, tenders, and contracts, as well as selecting, verifying and validating methods. This section covers areas such as sampling, test item handling, and technical record-keeping. Other requirements include reporting outcomes, managing complaints and non-conforming work and controlling data and information management, which is especially important in the current digital era.
Management System Requirements (Section 8): Section 8 deals with the laboratory’s management system, which must support consistent adherence to the standard’s requirements while ensuring the quality of the laboratory results. The section offers two options for the management system: Option A for new systems and Option B for existing systems driven by ISO 9001. The section consists of eight tasks which involve activities such as documenting the quality management system (QMS), identifying and addressing potential risks and opportunities, implementing measures for improvements and taking corrective actions. The final clause of the section involves conducting an internal audit of the laboratory’s management system to ensure it complies with the standard’s requirements.

Key Considerations for Selecting a Cannabis Lab Testing Software or LIMS

A cloud-based cannabis lab testing software to manage staff training with ease

Before selecting a Laboratory Information Management System (LIMS ) for your cannabis testing lab, it is crucial to comprehend the informatics requirements of your laboratory. This involves understanding analysis necessities, limitations on reporting and data sharing, demands for instrument interfacing, requirements for sample barcoding and tracking, and procedures for ensuring quality assurance. Once all this is in place, a laboratory should take into account the following considerations:

Technology Considerations

When considering technology options, it’s important to consider future growth, data management and security and regulatory responsibilities. If a laboratory expects to grow in the future, it should consider investing in technologies that could enhance data management practices and security. The laboratory must also take into account how compliance with ISO/IEC 17025 will impact its future expansion and technological needs. To determine hardware and software investment, the laboratory must consider the type of work it will be performing and the associated regulatory and customer-centric responsibilities. It is also essential to identify the person or team responsible for addressing any potential technological problems, like setting up and maintaining software. If the laboratory wants to avoid procuring IT infrastructure and hiring IT personnel for maintaining LIMS, they should deploy a cloud-based LIMS that eliminates the need to have an elaborate IT infrastructure or dedicated IT staff.

Cybersecurity Considerations

As the need for cybersecurity continues to grow in various industries, it has become apparent that cannabis testing laboratories are also vulnerable to cybersecurity threats regardless of size. Therefore, it is important to consider additional cybersecurity measures for these laboratories. Although the ISO/IEC 17025 standard does not explicitly mention cybersecurity, it does address the proper control of data in section 7.11. The standard emphasizes that LIMS, whether hosted locally or in the cloud, should be protected from unauthorized access and tampering. To comply with the ISO/IEC 17025 standard, laboratories should integrate cybersecurity considerations into their LIMS selection process. This can be achieved by creating a cybersecurity plan and including cybersecurity controls in the user requirements specification (URS) for LIMS software. Using a pre-built URS that includes cybersecurity controls can simplify the process of evaluating and selecting informatics software for laboratories. It is important to maintain the LIMS to ensure data and information integrity, recording any security breaches or non-conformance and addressing them promptly.

Regulatory Compliance Considerations

Meeting well-designed standards like ISO/IEC 17025 can enhance a laboratory’s operational culture and assure the reproducibility and accuracy of test results. If a laboratory is considering purchasing a LIMS solution and is unsure about how it can align with ISO/IEC 17025 and other regulations and standards, they can refer to resources like ASTM E1578-18 Standard Guide for Laboratory Informatics for guidance. The laboratory’s own requirements list can then be used as a checklist for vendors.

System Agility

Laboratories should consider if the LIMS under consideration can handle adding other types of testing, protocols, and workflows in the future. A flexible LIMS that allows for configuring various aspects of the system, such as sample registration screens, test protocols, labels, reports, and measurement units, is essential. When evaluating a vendor’s system, it’s important to understand what makes it user-configurable and how easy it is to make changes. Moreover, you must check if you can make changes in the system without requiring programming skills.

Cost Concerns

For a laboratory to have a clear understanding of what is included in the sales agreement, it is important to provide an estimate or statement of work (SOW) that outlines the details of the anticipated elements with as much specificity as possible. These elements should include the cost of licensing or subscription, core items needed to comply with regulations, the total cost of optional items, and the required services such as LIMS implementation, maintenance, technical support, training, product upgrades, and add-ons. There are two main pricing models for LIMS solutions: a one-time license fee and a subscription fee for cloud-hosted LIMS. If a laboratory has an internal IT team, it may prefer the one-time fee, but a SaaS subscription may be more cost-effective if they don’t have an IT team and want to save on hefty upfront cost. To accurately reflect the various pricing nuances, the estimate or SOW should specify whether the costs are for monthly or annual subscription services, hourly support and training, or a one-time fixed cost.

The ISO/IEC 17025 accreditation offers several benefits, including improved credibility, lower operational costs, and better conformity with local and state regulations. However, integrating ISO/IEC 17025 requirements into a laboratory’s practices can be challenging. That’s where a cannabis lab testing software comes in. Laboratory managers and staff must consider several critical factors when selecting a LIMS to meet the requirements of ISO/IEC 17025. Key considerations for selecting a LIMS to meet ISO/IEC 17025 requirements with ease include technology considerations, cybersecurity considerations, regulatory compliance considerations, system agility and cost considerations. By meeting the compliance requirements of the ISO/IEC 17025 standard, cannabis testing laboratories can ensure the quality of their results and provide trustworthy services to their customers.

July 3, 2023

Building An Integrated Pest Management Plan – Part 6

By Phil Gibson

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This is the sixth and final in the series of articles designed to introduce an integrated pest management framework for cannabis cultivation facilities. To see Part One, an overview of the plan and pest identification, click here. For Part Two, on pest monitoring and record keeping, click here. For Part Three, on preventative measures, click here. For Part Four, control methods, click here. For Part Five, pest control action thresholds, click here.

This is Part 6: Emergency Response

When all prevention efforts have failed and your escalation procedures must be implemented, your emergency response document takes the stage.

Figure 1: We never want to see these at our door

It sounds obvious, but your emergency response document is your team’s guide to structure your response to an emergency. This begins with the simple definition of what is an emergency for your business. Emergencies can be to your personnel (personal injury) or your infrastructure (broken pipes/floods, power failure), and finally, a pest or pathogen outbreak that threatens the entire facility (insects/fungus, molds). Be sure to get the advice of your local service providers on the important things to put in to your response plan. This article is far from an exhaustive list, but it can get you started quickly with the basics for example purposes.

Personal Injury

Personal injuries are the events where you would call your local fire or police resources after stabilizing trauma events. Examples are chemical exposure, cuts, lacerations or broken bones from falls or crush events, burns, electric shock or earthquake or weather events. Injury response is to assess, call for medical assistance if appropriate, provide first aid and stabilize the injured, move to safety if possible, treat the injury and after the event is over and still fresh in everyone’s mind, consider what can be done to avoid the repeat of this or similar events in the future. Work those changes into your standard operating procedures.

Emergency Response to Facility Events

Figure 2: Cultivation IPM Prevention with Beneficial Insects

Whether the event is broken pipes or flooding, power failure or interruption, fire, HVAC failure or weather event, emergencies come in all sizes possible. It is likely that you built up a plan for emergency response as part of your city permitting process. Be sure to use those experts to refine your plan to include your operations.

Broken pipes start with the basics of turning off the source feeds and fixing the plumbing. If the water is actually rich fertilizer nutrients, cleaning and disinfectant is necessary as part of the drying and mop up process.

Environmental damage from fire, HVAC or weather event, lead to immediate treatment to try and save the current crops. This would include manual watering/misting, portable heater/cooler/CO2 burners. Verifying that backup power supplies turned on as planned. Are emergency fixes sufficient to power or run the systems necessary for plant life until power is returned?

Cultivation Events

This entire paper has been about pest management, so emergency is expected to mean a pest or pathogen outbreak. We defined the escalated response actions up to the point of direct action and chemical interventions in chapters four and five. Your emergency response plan takes those actions to a site wide effort. Identify the pest and location/s that are causing the crisis, isolate the infested plants, remove the infected materials, clean, disinfect, and purify the contacted surfaces. Follow your plan and contact your emergency leaders.

Emergency Response Team

Your emergency response document identifies each of your team leaders and executives that are to be contacted in the event of an emergency. These leaders should be identified in the document with contact details and methods/on-call schedules for days and times of responsibility (after normal hours and holidays included). Someone is always on-call. The personal injury, facility and cultivation lead responsible should be identified and aware that they are the assigned resource and to treat emergencies as a priority.

In Conclusion

We have covered an example integrated pest management philosophy from prevention through observation to limiting expansion to treatment and review. This continuous monitoring and learning process is a living document of standard operating procedures for any facility.

The attention of your team, their scouting observations, and attention to detail give you an opportunity to address and restrict any pest outbreak before it destroys your crop. Teach your operators well and reward them for their attention to your plan.

Clean and sterilize your facilities regularly. Preventing the emergence of pests will pay for the investment in a multitude of ways in both savings and profits. Plan your response thresholds and use traps to monitor your escalating protections. Target your treatments and remediations to match the threats to your harvests. As a last resort, apply approved chemical treatments judiciously to minimize the impact on non-target organisms.

Evaluate the effectiveness of your plan on an annual basis. Put your improvements to work for you to minimize your pest footprint and to increase your profits in every harvest.

For a copy of the complete Integrated Pest Management guide, download the document here.

June 27, 2023

Building An Integrated Pest Management Plan – Part 5

By Phil Gibson

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This is the fifth in a series of articles designed to introduce an integrated pest management framework for cannabis cultivation facilities. To see Part One, an overview of the plan and pest identification, click here. For Part Two, on pest monitoring and record keeping, click here. For Part Three, on preventative measures, click here. For Part Four, control methods, click here. Our final chapter, Part Six, discussing emergency response, comes out next week to wrap it all up.

This is Part 5: Pest Control – Taking Action

Previous chapters have covered the many preparations you can take to protect your facilities from pest attacks and outbreaks before they get started. This chapter will summarize the concepts of pest control thresholds and the actions you can take for the painful event when you surpass those limits (and various examples). The Integrated Pest Management (IPM) recommendations provide you with a framework for these plans.

Figure 1: Cleaning regimen, the heart of successful operations – no biofilm buildups

Preventative actions are part of your regular site operations; in other words, they are how you avoid problems before they happen. Just to hit this action one more time: cleaning must be fundamental to your facility. Water sanitation and changing filters must be done on schedule and frequently to avoid biofilm build up and nasty self-multiplying eco-systems.

For each of the rooms in your facility, identify the acceptable tolerance level for each type of pest that you may encounter. Define the intervention levels per room: preventative, direct action and escalated direct action. Follow your predefined procedures and defend your facility. Let’s cover high, medium and low tolerance example responses.

High Threshold for Tolerance

For example, the impact on your plants, your profits and your yields from the discovery of a white fly fluttering inside of one of your flower rooms may be very small. If this presence is late in your harvest cycle, your tolerance of this discovery may be very high. Your team could take preventative actions to clean the room more aggressively or to check your traps more frequently, but you are probably not going to want to invest in aggressive actions at that time in the harvest cycle.

Move from passive observation to the shake test. With sticky traps in place, shake or brush your plants. Do you see the bug counts increase on your test sheets?

Figure 2: Thrip Evidence c/o UC ANR Publication 7429

As that infestation grows, you may set a threshold for direct action (i.e. 5-10 flies per trap per week). If you reach that level, implement a treatment action with a non-chemical microbial biofungicide to stop growth in the roots or neem oil as a direct chemical action.

When you reach your escalated threshold of 10-20 flies per trap or direct plant damage is apparent, an infestation is more serious. In that event, you may choose to take steps to directly reduce the pest population with knock down sprays of approved direct chemical pesticides like citric acid or insecticidal soaps. Be sure to use your Personal Protective Equipment (PPE) for breathing and contact safety if you get into this situation.

Medium Threshold for Tolerance

Depending on the timing in your harvest cycle, the discovery of fungus gnats in your grow room may trigger a medium level alarm for you. Is the location, a small example with a minimal frequency? Is this addressable with additional attention to cleaning the area and longer dry periods in the irrigation or is this the beginnings of an infestation? Fungus gnats feed off of fungus or organic matter in soil triggered from an overly moist root environment. You may choose to react with immediate cleaning at the first existence in a room. Or you could set your “Medium” level alert status to be additional sticky trap distribution at the first visible gnat. If those counts reach 10-20 gnats per sticky trap per week, begin your foliar spray regimen with Zerotol or the equivalent.

If these counts do not respond to your treatment, meaning that the next sticky trap count reaches beyond 20+ gnats per trap or visible direct plant damage, then institute your root drench protocol with a solution of BActive 1-2 times per week until the problem is under control and the counts are reduced. If the growth continues, look to approved pesticides in your area (as an example, AzaGuard Asadirectin).

Low Threshold for Tolerance

Alternatively, you may have a unified air circulation system due to facility limitations. Your air circulation may be shared across all of your mother plants, clones, veg and flowering plant areas. In that case, any presence of an airborne fungal infection like powdery mildew would have a very low tolerance of acceptance. Selective de-leafing of the infection and increased airflow are your first defense. Any visible presence beyond that would trigger a low threshold alert and immediately start a preventative action, such as carefully removing the infected plant material much wider than a few leaves and treating the area with foliar sprays like Zerotol (hydrogen peroxide plus).

If the penetration continues or expands, treatment would escalate to minimal risk pesticide follow up and observation. Chemical oils or citric acid might be in your mix in this case.

Finally, if repetitive treatments once a week are not turning the tide, increasing to once per day or even once per ON/OFF lighting cycle until the infection is controlled. At this point, you may decide to strip the room down and start over. Clearly the choice to “throw in the towel” is a total loss of the crop, but it may be the best option relative to minimal yields and failed flowers that will not sell.

Pest Control Actions

Our Integrated Pest Management recommendations paper gives you examples of what to consider for plans with white flies, fungus gnats, root aphids, powdery mildew and biofilm on plumbing or surfaces. These follow the preventative action, direct action, escalated direct action and pesticide approaches for each example. These are options to plan for water sources, root treatment, tunneling, crawling and flying phases.

In summary this week

As covered, preventative measures are your best defense. Hire expert consultants and plan these well. Escalate your response based on your scouting activity and your plan. Add your sticky traps, de-leafing, root drench, foliar sprays or knock down sprays as defined by your pest population control actions document.

For more detail on each of these treatments, you can see examples for your integrated pest management procedures in our complete white paper for Integrated Pest Management Recommendations, download the document here.

In our final chapter, Emergency Response, we will review control thresholds and example plans for a range of problems from biofilm build up to white flies and more.

Our final chapter after will describe emergency response framework and reviewing your complete plans. See you next week.

June 20, 2023

An Inside Look at the Creation and Growing Popularity of Solventless Cannabis Products

By Tim Nolan

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A top product trend this year is the rise of solventless cannabis products, according to recent statistics from cannabis market analyst firm BDSA. In fact, from June 2021 to June 2022, BDSA research also showed that the category grew an average of 132% each month.

Nearly all cannabis products start with cannabis concentrates, which are made with a solvent that contains the desirable compounds from cannabis. Solventless concentrates however are made from the cannabis flower without the use of any chemicals and are becoming popular among businesses and consumers. This broad category of cannabis products includes everything from hash to live rosin.

Mitch Lindback, Lab Director at Copperstate Farms, has been growing and extracting cannabis for 15 years and has over a decade of experience working with cannabis derivatives. “Solventless is the truest expression of the cannabis plant,” he says.

Copperstate Farms is one of the largest greenhouse cannabis producers in North America and home to 1.7 million square feet of canopy and 40 acres under glass. Here is an inside look into the company’s solventless creation process:

The Harvest

One of the most important growth factors in cannabis is light, so cannabis grown in full-spectrum light often brings the best flower to harvest. In the weeks before harvesting, the lab conducts a test wash on cannabis plants before hand-selecting which will be used in rosin. Plants are selected based on appearance, aroma and test wash results. On harvest day, all flowers are lightly hand-trimmed and frozen within two hours of harvest.

The Wash

Using only chilled RO water and minimal ice, our cannabis extraction experts gently break the trichome heads off the fresh-frozen cannabis using a stainless-steel wash system, by gently agitating the flower. Then they collect the 73μ-159μ trichome heads while pushing the immature trichome heads and stalks to pass through collection bags with a cold spray wash.

The Press

After carefully freeze drying, sifting and packing the hash into double-wrapped mesh rosin bags, Copperstate Farms uses rosin presses to gently express the nectar from the trichome heads using a little heat and a lot of pressure.

The Cure

All live rosin goes through a minimum 7-day cure. “We have found through extensive analytical testing that curing rosin for a minimum of seven days increased its terpene content by over 30 percent,” Lindback says.

The extensive process to create solventless cannabis products is time and energy intensive, but leads to quality offerings, like full melt hash and live rosin. In fact, the solventless category is “primed for premiumization and growth in legal cannabis markets,” according to BDSA retail sales analytics. This is especially true in the dabbable concentrate product category and predicted in the vaping concentrate category as well.

With popular annual holidays like 7/10 (the cannabis community’s holiday for celebrating oil products, dabs and concentrates) gaining traction, solventless products are predicted to grow in market share and are worth cannabis companies looking into producing as demand rises among consumers who are always looking for innovative products that feature solventless concentrate.

To learn more about Copperstate Farms, visit www.copperstatefarms.com.

June 14, 2023

The Sensory Branding Opportunity for Cannabis Products

By Dr. Ed Szczygiel

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Cannabis brands are facing a proverbial fork in the road: determining whether their product evolves into a luxury consumable or affordable agricultural commodity. While it is reasonable to assume the cannabis market space will organically grow into a luxury goods industry such as wine and spirits, the luxury brands that serve as the foundation of these markets were built over years of engagement between consumers, connoisseurs and producers. If cannabis companies want to successfully market their products as luxury items, a concerted effort towards well-defined, consumer-accessible branding is required.

The first step towards evolving a cannabis brand towards luxury is overcoming the fixation on cultivar identity. Unregulated cultivar naming currently impedes creativity and craftsmanship, disrupting brands and salespersons’ abilities to clearly communicate strain aesthetics.

The good news is the alcohol, coffee and consumer packaged food (CPG) industries have done most of the heavy lifting, paving the way with robust sensory science and analytical approaches to product characterization. Cannabis stakeholders need only adapt their tools and apply them to cannabis with similar intention.

Research suggests that aroma is one of the strongest predictors of positive consumption experience. As adult use consumers become familiar with current product offerings and increasingly legal availability, they will seek products that consistently yield the best experience. The most successful brands will be those that most effectively communicate that experience and then deliver it. The status quo – describing aroma using strain names, top terpenes or THC content – is not effective at harmonizing a brand’s promise with consumer experience.

Figure 1: Illustration of both the conventional branding approach (top) and the sensory-based branding opportunity (bottom).

The conventional cannabis product branding approach leaves to be desired a tremendous opportunity to characterize cultivars (Figure 1). Sensory science, the discipline used to evoke, measure, analyze and interpret reactions to materials through human perception, has been used for decades to characterize CPGs from skin lotion to washing machines. Adapting these well-established techniques for use in cannabis can be challenging, but it is certainly worth the investment.

These shifts in the cannabis industry have already begun to occur. I recently was the principle investigator on a white paper that presented a novel cannabis aroma wheel derived from aroma descriptors and a panel of trained sensory experts. In the study, sensory scientists evaluated randomly sampled cannabis flower over a period of several months. The researchers combined qualitative focus panels, literature review and formal blinded sensory tests to develop a comprehensive lexicon that served as a tool for trained evaluators to characterize cannabis aroma. This novel and robust tool (Figure 2) was designed to be used by trained panels to characterize cannabis aroma, is freely available and is just the beginning of a collective development of a data-driven cannabis lexicon.

Much like the World Coffee Research Lexicon referenced here, the Cannabis Aroma Lexicon is a tool with a specific purpose: collecting an objective description of the product aroma. It is a living document that will grow along with the industry. In the future, we may have lexicons to describe more than just aroma. Tactile and appearance sensory attributes of cannabis will gradually be defined by sensory scientists, presenting more opportunities for deep craftsmanship in the cannabis industry.

The role that dispensaries play in adoption of standardized quality metrics is critical. The product features that position cannabis to be a craft product warrant the presence of a third-party expert to translate and guide consumers during the purchasing process. It’s intuitive to ask a waiter to recommend a pairing (i.e., a dry red wine to pair with a seafood dish), given the trust that consumers put in the restaurant to understand the properties of the food they are serving. Dispensaries have thus far filled the service structure role for cannabis, but the vast amount of unknowns regarding the physiological and sensorial effects of cannabis have resulted in inconsistent experiences that leave something to be desired in terms of consumer trust.

Application of sensory science in cannabis is an unparalleled opportunity for brands to build consumer trust and differentiate their products in a sea of strain names and high potency flower. Cultivars that can be established as measurably aromatic in a specific character can leverage that aroma profile to add significant value to the product. For example:

Cultivar name can be aligned with the perceived aroma (e.g., garlic is not bad, but expecting tropical and getting garlic can harm consumer trust).
Product catalog can be consolidated and optimized to avoid sales cannibalization by growing specific products to meet consumer group’s needs.
Guesswork is removed from breeding by measuring when a product is meeting sensory goals and ensuring it doesn’t drift over time.
Demonstrating transparency will win over ethical consumers. Utilizing controlled, blinded studies to profile aromas will add value to ethics-minded consumers.
Becoming a leader in connoisseurship. In the forefront of this shift in branding, one can position a brand to be ahead of the competition.
Elevating the dispensary experience. By utilizing aroma profiling, products can be more easily sold by budtenders and salespeople.
Opening doors to new application types (e.g., seasonal, occasion centered or geographically unique cultivars).

These are just some of the ways that aroma characterization will differentiate products and simultaneously contribute to cannabis brands’ ability to communicate craftsmanship and the maturity of the industry as whole. Not only will adoption of robust sensory-based branding improve the consumer experience by providing a means to compare products to one another, it will promote adoption of good manufacturing practices that simultaneously improve the quality and safety of cannabis products. Without consumer-accessible quality metrics, brands have little incentive to produce products of elevated quality and are conversely incentivized to prioritize quantity and meet minimum regulatory requirements.

Importantly, cannabis businesses will use this tool to adapt to an inevitable industry-wide shift towards connoisseurship and application of robust sensory science. While it may be challenging to shake off the “bad habits” that currently plague many brands, cannabis has significant potential as a luxury good. Consumers are eager for a better cannabis experience from purchase to consumption. How will your brand use sensory profiling to expand or evolve product offerings to succeed in a cannabis market full of luxury brands and what steps will you take now to prepare?

June 7, 2023

Building An Integrated Pest Management Plan – Part 3

By Phil Gibson

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This is the third in a series of articles designed to introduce an integrated pest management framework for cannabis cultivation facilities. To see Part One, click here. For Part Two, click here. Part Four comes out next week and covers direct control options for pest reduction. More to come!

This is Part 3: Preventive Measures

Preventive measures are a great investment in the profitability of your operations. Our objective is to ensure successful repeat harvests forever. Build your procedures with this in mind. This means maintenance and regular review. We all realize that this work can be monotonous drudgery (we know!), but these procedures will ensure your success.

Figure 1: New Air Shower Access Installation

As a summary to begin, pest access must be limited wherever possible. Employees are the first place to start, but we must also return to our site map and review our facility design and workflows. Every operation has to move plants from nursery through harvest and post-harvest. Where should cleaning happen? Of course, you have to clean up post-harvest but when should this occur during the grow cycle? What is the best way to monitor and clean environmental management systems (i.e. air, water) and what are the weaknesses in the physical barriers between operations? Let’s walk through these issues one-by-one.

Employee Access and Sterile Equipment

Follow procedures to screen and protect your employees both to eliminate pests and to avoid exposing your employees to harmful chemicals or storage areas. Look for ways to isolate your workflow from pest access. Be certain that your facility is airtight and sealed with filtration of molds, spores and live organisms in your air intake areas. Air showers at your access points are important to screen your employees on their way into your gowning areas and grow facility. Clothing should be standardized and shoe coverings or crocs should be provided for all employees that access your interior. Look for ways to stop all pests (embedded, crawling, hopping or flying) in all of your room assignments (mothers, clone, veg, flower, trim and drying). This can be improved with shoe baths, sticky mats, frequent hygiene (hand washing and cleaning stations) and procedures for entry.

Always consider requiring hair & beard nets, shoe covers and disposable gloves in plant sensitive areas.

Chemical Access & Protective Equipment

Figure 2: Example Facility Map – Understand Workflow & Barriers to Pest Access

Personal protection equipment (PPE) is very important to protect any employee that will come in contact with materials, liquids or vapors for chemical resources. Establish procedures for chemical use and train employees in the safe handling of these materials. Typical equipment includes high density chemical protective gloves, boots, respirators, Tyvek (or equivalent protective wear) suits and eye protection or goggles.

Chemical access areas and their use should be restricted to employees familiar with their authorized application. Always remember that cannabis is an accumulator plant, and it will absorb and hold onto chemical treatments. Appropriate isolation and safety procedures must be followed for chemical use. Not following these restrictions can expose your employees to dangerous chemicals or get your entire harvests rejected at testing.

Facility Map & Workflow

Because insects would like to be everywhere and they come in many types (root zone, crawling, flying, microscopic, bacterial or biofilm), the facility workflow must understand where they are and how they might migrate if they penetrate your defenses. Note airflows in your rooms and fan locations so migrations can be predicted once an infestation is located. Where are your opportunities for full clean-up and disaster recovery in your building? Where should you stage maintenance filters, test kits, water and cleaning materials. How best to clean up and dispose of sealed garbage containers or cleaning materials?

Operational Cleaning & Post-Harvest Reset

When compiling your preventative measure documents, it is critical to create a repeatable operating procedure for cleaning and sanitizing your rooms, systems, and growing spaces after each harvest. Plant material handling, cleaning surfaces and wipe methods should all be documented in your Standard Operating Procedures (SOPs). Define what “clean” is. Removing plants and plant debris is pretty clear but define how to drain reservoirs, clean pipes, change filters and clean and sterilize your rooms. Operators must be trained in these SOPs and reminded of their content on a regular schedule. This is how you avoid outbreaks that can crush your profits.

Physical Barriers & Maintenance

Document your sealed spaces and define your normal room and access door barrier interfaces. Review the status of any known cracks or gaps in your perimeter. Are there any known leaks or piping that has been seen as a risk or a problem in the past? Are there any discoloring or resident mold locations (Never happens, right?). Baseline how much time and people resource a harvest operation and cleaning effort should take. Will you do this after every harvest or compromise your risk by delaying to every third or fourth harvest? Create your barrier SOP.

Environmental Control & HVAC

Managing the air quality provided to your plants is critical to your yields. Controlling CO2, air movement rates (the leaf happy dance), humidity, air filtration and sterilization methods must be maintained and cleaned on a regular basis. Do you need to change the HEPA or other particulate filters? Is there any UV light sterilization maintenance? We have all seen the home HVAC air conduit cleaning commercials. Your commercial facility is no different. How will you clean your air and water plumbing systems? How often will you perform this full reset? When will you calibrate and data log your sensors for temperature, humidity, CO2 and water resources? Put everything about your environmental set points into your maintenance document and decide when to validate these. Molds, mildews and biofilm hazards are all waiting for unmonitored systems to open the door for access.

In Conclusion, This Week

If you’re an IPM nerd and this dynamic topic did not put you to sleep, you can read more detail and examples for your integrated pest management procedures in ourcomplete white paper for Integrated Pest Management Recommendations, download the document here.

In our next chapter, Direct Control Options, we will review what you can use to protect or recover control of your facility including both chemical and non-chemical tools and methods. In our final two chapters, we will discuss extermination of the determined pests that breach your defenses. And with great expectations, our final chapter will discuss emergency response and time to go to war!

Part Four comes out next week. See you again soon!

May 31, 2023

Building An Integrated Pest Management Plan – Part 2

By Phil Gibson

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This is the second part of a series of articles designed to introduce an integrated pest management framework for cannabis cultivation facilities. To see Part One, click here. Part Three comes out next week and covers prioritization and preventative measures. Stay tuned for more!

This is Part 2: Pest Monitoring, Record Keeping, & Communications

Begin your pest identification process with a pest scouting document. You have already mapped out your facility with locations and potential access locations. For each of these pest types and room type assignments (mothers, clone, veg, flower), identify your employee scouts, their scouting methods, scouting frequency and the type of likely pest they are to search for and count.

Insect Types and Tracking Methods

Figure 1: Example Sticky Trap Scouting Map

Insect pest types include, but are not limited to, airborne flying or crawling insects, their various egg, lymph, larvae, pupal shells or immature forms. Look for trace remnants, plant damage or feces that let you know they are present in some form. If they are at the mature jumping or flying stage, this can be harder to count, but sticky traps distributed on an even basis around your rooms can make the counting process more consistent from survey to survey.

Note airflows in your rooms and fan locations so migrations can be predicted once an infestation is located.

Insects Can Be Everywhere – Crawlers & Fliers

Insects would like to be everywhere so they come in many types from the obvious flying and crawling types to root-zone microscopic, aquatic, fungal, bacterial or biofilm based. For those of you using soil or media, root-zone insects can be beneficial by digesting and breaking down organic matter into something useful for your plant’s roots (earthworms) or harmful by feeding directly on your plant roots and sucking the life out of your plants from out-of-sight below (nematodes, maggots).

Common pests in a cannabis environment include:

White flies – Oval shaped eggs on the underside of leaves, nymphs- oval crawlers that suck on the undersides of leaves, larger stage nymphs with pupae shells as they form wings and mature white flies.
Fungus gnats – Clear eggs deposited in overly wet soil or dead plant matter. Clear or white colored larvae in the soil or media, these worm-like critters go through multiple stages of molting as they grow, eventually pupating into brown cocoons and finally small black or dark flies with clear wings that flutter around your plants and suck on your leaves.
The dreaded spider mite – Clear, hard to see eggs on the underside of your leaves. These six-legged tiny moving bubbles begin the feeding as larva, add 2 legs in the intermediate and mature nymph stages and finally the oval shaped spider mites that every grower despises, adding their webs around the tops of your plants as their nurseries suck the life out of your flowers.

Insect Transfers of Bacterial Infections

Many crawlers or fliers you may discover in your grow operation do not generate fungus or bacteria on their own. However, they do routinely pick these up along the feeding way and bring them into your shop. Sap-feeding insects like leafhoppers and aphids use their needle mouths to pierce your leaves to suck on the sap that is nourishing your greenery. These insects consume the fluids and transfer bacteria as they feed. Whiteflies fit into this category of leaf sucking bacteria carrying pests. These pests can make your healthy grow rooms look blotchy with color drained out of your canopy.

Obvious symptoms of these flying/hopping pests are sticky leaves, black fungus mold, or yellowing leaves that show up at the bottom of your plants and work their way upward as the infestation progresses. Leaf curling or plant wilting will be visible in the more advanced stages of these pests.

As if crawlers were not bad enough, invisible fungus and bacteria that get into your water supplies can be the worst challenges of any grow.

Water Sourced Bacteria

Baseline testing of your feed water is critical for any facility. This is true whether you are using surface water, well water or municipal water. Please see the water tutorials on the AEssenseGrows website for details on how to test your water sources and what to look for in the mineral content.

Regardless of your water source, bacteria can be present directly in your water supply, or it can be introduced from infected plant materials from one of your suppliers. Pythium, fusarium and the latest plague, hop latent viroid, are some of the most common threats that attack your plants from your water or soil sources. These can come from your wells, feed lines or plant materials.

Reverse osmosis (RO) is a typical method to clear water of most pathogens and bacteria using water that is pressed through filters with very small membrane apertures. These small openings usually stop impurities, salts and microorganisms. Of course, these systems come in many different types and they have to be maintained to keep their performance quality. Don’t take shortcuts on your RO system.

Once your water source is clean, strict hygiene procedures for tools, equipment and plumbing are the best way to minimize these threats to your plants downstream from your water source. These cleaning efforts are not a guarantee. Pests can still get into even the best facilities. Symptoms of these maladies vary, but root rot, stunted growth, wilting, discolored roots or leaves, and in some cases, the quick death of your plants is possible depending on the critter.

Use your scouting regimen and your data mapping to locate infestations before they expand and damage your facility. Isolate outbreaks and take appropriate measures to address the pests. We will give you suggestions on prioritization and preventative measures to take in the next chapter.

Pythium is one of the most commonly harbored soil or water carried pests. When it is present and gets into your plants through cuts, natural openings, root surfaces or leaves on weakened plants, it can be devastating. In hydroponic systems, dirty looking brown roots evolve into full root rot if not addressed. Pythium is often the cause. In soil operations, pythium often shows up as wilting or yellowing patches on leaves.

Your lab testing partners are your friends when it comes to bacterial or fungal infections. Many diseases can resemble one another. It is not hard to misdiagnose environmental stress such as overheating or overwatering for a bacterial problem. Test results are necessary to accurately diagnose a problem.

Truly Airborne Molds & Mildews

Pythium and fusarium are not just present in water. They can also be airborne. Grey mold (botrytis) and powdery mildew are also common airborne pests. Proper humidity, air movement, air filtration and sterilization using HEPA (High-Efficiency Particulate Air) filters, activated carbon filters (also filter smells) and UV light sterilization can minimize these problems in your grow. Powdery mildew is the primary evil spore in this category. Airflow and regular cleaning to discourage fungal growth is the best way to limit these pests.

In conclusion, this week

Now that we have talked about identification (and clearly, this is not an exhaustive list), we will move into how to build in the cultural methods to prevent these problems from taking hold and ruining your business. In later chapters, we will dive into prioritization, treatment and control options for infestations, finally moving into control actions and emergency response.

Your integrated management response is how you pull all of this together and use your IPM procedures to increase your profitability. For the complete white paper on Integrated Pest Management Recommendations, download the document here.

Part three comes out next week and will delve into the world of Preventative Measures. Stay tuned for more!

May 30, 2023

A Research Study on the Antimicrobial Properties of Cannabis

By Cindy Orser, PhD

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Inexpensive in vitro Methods to Evaluate the Impact of Cannabinoid-containing Products on Sentinel Lactobacillus spp.

S. Lewin ¹, A. Hilyard², H. Piscatelli¹, A. Hangman¹, D. Petrik¹, P. Miles², and C. Orser²

¹MatMaCorp Inc, Lincoln NE; ²Apothercare LLC, Boston MA

Abstract

The public has readily embraced cannabidiol (CBD) in countless unregulated products that benefit from commercial promotion without FDA oversight, who recently concluded: “that a new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products w/ the regulatory oversight is needed to manage risks.”¹ The reported antimicrobial properties of CBD combined with the recent proliferation of cannabinoid-containing products marketed to women for intimate care led us to explore the impact on the sentinel lactobacilli species associated with a healthy reproductive tract. Except for lubricants and tampons, the FDA regulates intimate care products as cosmetics. Even non-cannabis serums, washes, and suppositories are not required to be tested for their effect on the reproductive microbiota. We aimed to investigate the utility of easy-to-use, inexpensive in vitro assays for testing exogenous cannabis products on reproductive microbiota. In vitro assays can provide important evidence-based data to inform both manufacturers choosing both an active cannabinoid ingredient source as well as excipient chemicals and consumers in the absence of safety or quality data. In simple, straightforward exposure studies, we examined the antimicrobial activity of CBD and cannabigerol (CBG) on the most dominant vaginal lactobacilli species, L. crispatus, associated with good health.

Introduction

The testing of readily available products containing cannabinoids, predominately CBD following the widespread legalization of hemp by the 2018 US Farm Bill, is not required beyond ensuring THC content is below 0.3%. Therefore, basic information on safety, quality, antimicrobial activity, bioavailability, and dosing is unavailable and undocumented. The situation is further complicated by the complex chemoprofiles of cannabis extracts based on the cultivar, the extraction methods and subsequent cleanup, and other chemical excipients in the formulation. The FDA has finalized guidance on quality considerations for clinical research for the development of cannabis and cannabis-containing drugs intended for human use.

One approach to backfilling non-existent safety and quality data for cannabinoid active ingredients and those products made from them is to apply or devise assays that can provide relevant toxicity data in an in vitrosystem. Farha et al. (2020) reported that seven cannabinoids are potent antibiotics, including CBD and synthetic CBG. CBG inhibited the growth of gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA), but not gram-negative bacteria unless their outer membrane was permeabilized (Farha et al. 2020). In addition, several volatile terpenes, the main constituents of essential oils extracted from Cannabis sativa L., also have potent antibiotic activity against gram-positive bacteria (Iseppi et al. 2019). We have previously written about the risks associated with disrupting the healthy microbiome of gram-positive vaginal bacterial species leading to dysbiosis (Orser 2022) and its further health complications.

Several successful approaches to assessing the toxicity of CBD have already been reported including human cell culture work by Torres et al. (2022) who showed that pure CBD has a repeatable impact on cell viability, but that hemp-derived finished CBD products had variable impact. Cultured human cell viability experiments demonstrated similar potencies across three different hemp-derived CBD products in the microgram per milliliter [mg/mL] range with increased viability at lower doses [2-4 mg/mL] and decreasing cell viability above 6 mg/mL (Torres et al. 2022). In the same study, the authors demonstrated that the presence of terpenes, specifically b-caryophyllene, in hemp extraction matrices also impacted cell viability.

Neswell, a cannabis therapeutics company in Israel, demonstrated through the application of their in vitroneutrophil cell line that cannabis extracts have inherent immune response biodiversity, suggesting that the choice of a cannabis source should be based on its function rather than on its chemoprofile (https://www.neswell.net). Inflammatory cytokine levels in inflamed peripheral blood mononuclear cells (PB_MC) showed a 10-fold difference across hemp extract products containing unidentified terpenes in suppressing the inflammatory cytokine, TNFa (Torres et al. 2022). The influence of CBD concentration on inflammatory cytokine production was previously reported by Vuolo et al. (2015) and Jiang et al. (2022).

Materials & Methods

Chemicals and Products Tested

THC-free, 99% pure CBD and CBG isolates were purchased from Open Book extracts in North Carolina (openbookextracts.com). All other chemicals including erythromycin (EM), and growth media were obtained from Sigma-Aldrich (St. Louis MO). Specific reagents in the qPCR kits were assembled in-house at MatMaCorp Inc. (Lincoln NE).

Monitoring Cell Viability: OD600nm and plating

Individual frozen glycerin stocks of L. crispatus HM103 from BEI Resources Repository served as inoculum to streak on a sterile MRS agar plate and incubated anaerobically at 37⁰C for 24-48 h until individual colony growth was observed. Single colonies were used to inoculate MRS broth and incubated for 24-48 h at 37⁰C which served as the inoculum for exposure to test products. Exposed cultures and all control cultures were incubated at 37⁰C for 48 h with OD₆₀₀ readings taken at time zero, +24 h, and +48 h using disposable cuvettes in a standard spectrophotometer. The products were also plated onto MRS agar plates to evaluate inherent contaminants that could affect turbidity values.

Molecular Analysis by qPCR

DNA isolation from bacterial cultures was done using the MatMaCorp (Lincoln, NE) StickE Tissue DNA Isolation kit modified for bacteria as per manufacturer instructions. Briefly, a lysis buffer is applied to the sample followed by a heating step, and a binding buffer is added, thus allowing DNA from the solution to bind to the matrix of the StickE column. The column was washed prior to eluting the purified DNA. Per manufacturer instructions, 10 µL of isolated DNA was used as a template for genetic analysis in a Lacto-TM assay (MatMaCorp). The assay is a customized TaqMan-based detection assay that is conducted using a four-channel fluorescence detection platform, the Solas 8 (MatMaCorp). The assay was designed to detect the unique 16S-rRNA DNA sequence for L. crispatus. Briefly, the assay is a probe-based method that begins with hybridizing the custom-designed probes with their desired nucleic acid target found in the sample. Once hybridized, detection takes place from the fluorescently labeled primer. The target has been assigned a channelon the Solas 8 and is detected independently.

Calling the Results

The calling algorithm uses first-order kinetics reaction properties (inflection point detection) in combinationwith a measure of the closeness of the signals associated with a specific target. Various indicators are tracked during the reactions to perform an on-the-fly analysis. The analysis is then consolidated by a measure of the similarity between the fluorescence signals at the end of the run. Aggregating values from the similarity measure, the end gain and the inflection point detection allow the Solas 8 software to make the call at the end of the run without having to compare a results library of known sample targets.

Results

Exposure of L. crispatus

Anaerobically grown cultures of L. crispatus were exposed to either CBD isolate or CBG isolate at each of two concentrations [5 mg/mL] and [10 mg/mL] with all appropriate controls. All treatment groups were evaluated by qPCR, turbidity at OD₆₀₀, and plate counts.

Molecular Analysis via qPCR

These data show the specificity of the Solas8 testing for evaluating these products, as a molecular-level screening is not influenced by test product solubility, opacity, or non-specific contamination present in some of the tested products that can interfere with optical density measurements.

Growth Monitoring

Turbidity monitoring, albeit non-specific, confirmed the species-specific qPCR findings, that is no inhibition for the two cannabinoid isolates evaluated (Fig. 2).

Conclusions

In this limited in vitro study using a sentinel lactobacilli response, we have shown that 99% pure CBD and CBG isolates were not inhibitory at the two doses evaluated by complementary observations following turbidity, plating, and by qPCR. Limitations in this study prevent definitive conclusions regarding what individual or combination of cannabinoids or other cannabis secondary metabolites are inhibitory in vivo to dominant lactobacilli species in the reproductive tract. These limitations include commercial product testing without knowledge of excipients or impact on the bioavailability of any active cannabinoid ingredients. In addition, dose-response curves were not generated and exposure under micro-aerobic conditions was not carried out.

Cannabidiol’s potential as an antimicrobial agent may be limited by its extremely low solubility in water and a propensity to stick to spurious proteins limiting systemic distribution in the body as a therapeutic. Interpreting microbiome study findings to human health outcomes will require multi-disciplinary corresponding clinical data findings of disease diagnosis, processes, and treatment within populations. Nonetheless, this nascent translational research opportunity is vast with the promise of benefiting patient outcomes (Wensel et al. 2022).

Health Canada released a scientific review report on products containing cannabis, specifically containing 98% or greater CBD and less than 1% of THC (Health Canada 2022) while the FDA just concluded that there are no existing guidelines applicable for recommending safety and quality guidelines to manage risk for CBD products (U.S. FDA 2023). The Health Canada committee unanimously agreed that short-term use of CBD is safe at 20 mg per day up to a maximum dose of 200 mg per day and that packaging should include both dosing instructions and potential side effects. The Committee did not address the antimicrobial potential of CBD or CBG formulations or specifically vulvar or vaginally administered cannabinoids. There is clearly more basic physiological research needed on the impact of self-administration of CBD preparations based on the route of exposure.

References

1. https://fda.gov/news-events/press-announcements/fda-concludes-existing-regulatory-frameworks-foods-and-supplements-are-not-appropriate-cannabidiol

Farha MA, El-Halfawy LM, Gale RT, MacNair CR, Carfrae LA, Zhang X, Jentsch NG, Magolan J, Brown ED (2020) Uncovering the hidden antibiotic potential of cannabis. ACS Infect Dis 6:338-346.

Health Canada (2022). https://www.canada.ca/content/dam/hc-sc/documents/corporate/about-health-canada/public-engagement/external-advisory-bodies/health-products-containing-cannabis/report-cannabidiol-eng.pdf

Hopkins AL (2008) Network pharmacology: the next paradigm in drug discovery. Nat Chem Biol 4(11):682-90.

Iseppi R, Brighenti V, Licata M, Lambertini A, Sabia C, Messi P, Pellati F, Benvenuti S (2019) Chemical characterization and evaluation of the antibacterial activity of essential oils from fibre-type Cannabis sativa L. (Hemp) Molecules 24:2302; doi:10.3390/molecules24122302.

Jiang Z, Jin S, Fan X, Cao K, Liu Y, Want X, Ma Y, Xiang L (2022) Cannabidiol inhibits inflammation induced by Cutibacterium acnes-derived extracellular vesicles via activation of CB2 receptor in keratinocytes. J Inflammation Res 15:4573-4583.

Orser CS (2022) Prevalence of Cannabinoid-containing Intimate Care Products Exposes Longstanding Unmet Need for Safety Data on Community Microbiota Exposure. https://cannabisindustryjournal.com/feature_article/intimate-care-products-with-cannabinoids-need-more-safety-data/

Torres AR, Caldwell VD, Morris S, Lyon R (2022) Human cells can be used to study cannabinoid dosage and inflammatory cytokine responses. Cannabis Sci & Tech 5(2) 38-45).

U.S. FDA (2023) https://www.fda.gov/news-events/press-announcements/fda-concludes-existing-regulatory-frameworks-foods-and-supplements-are-not-appropriate-cannabidiol

Vuolo F, Petronilho F, Sonai B, Ritter C, Hallak JE, Zuardi AW, Crippa JA, Dal-Pizzol F (2015) Mediators Inflamm 538670

Wensel CR, Salzberg SL, Sears CL (2022) Next-generation sequencing insights to advance clinical investigations of the microbiome. J Clin Invest 132(7):e154944. https://doi.org/10.1172/JCI154944.

May 24, 2023

Ask the Experts: Supply Chain Risks in Hemp & Cannabis

By Cannabis Industry Journal Staff

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There are a lot of risks throughout the entire supply chain in the cannabis and hemp markets. Legal and regulatory issues, quality control reliability, security problems, product safety, potency, and constantly changing supply and demand are just a few major risks cannabis operators must stay on top of. A lot of companies mitigate these risks by implementing programs to find the source and figure out what actions could alleviate it. Those actions can look like reviewing testing or certification reports, auditing supplier facilities, and much more.

Jennifer Lott, AMAS Service Delivery Director for the standards certification body, BSI, has over 25 years of experience in quality, safety, lab management, consulting, packaging, and systems development. She’s an expert in GMP, ISO 22716, 21 CFR 117, 21 CFR 111, 21 CFR 210-111, ICH Q7, WHO GDP, RSPO, food safety, GMP/HACCP and much more.

She is a panelist for an upcoming webinar, Supply Chain Risks in Hemp and Cannabis June 27, 2023. During that webinar, she’ll join other experts where they’ll discuss some of the supply chain risks cannabis companies face and what they can do to mitigate those risks.

Ahead of her webinar, where she’ll take a deep dive into supply chain risks, we sat down with Lott to get a preview for what she’ll talk about.

Q: What are the major supply chain issues faced by the cannabis and hemp markets currently?

Jennifer Lott: The U.S. market remains highly complicated for cannabis companies and investors. Fewer than half of U.S. states and territories have legalized recreational cannabis use as of Nov. 2022.

To this day, cannabis is still a Schedule one substance under the Controlled Substances Act, alongside drugs like heroin, LSD and ecstasy – an issue that has led to several regulatory and fiduciary challenges for growers, processors, and distributors of cannabis/hemp.

Legal concerns aside, cannabis companies operate much like other businesses and face almost the same exposures that most enterprises do. Here are the top risks cannabis businesses encounter, according to experts.

Distribution – Current regulations prevent products from one state to be transported to another state.
Natural disasters – including wildfires, storms, and flooding, can easily damage crops
Cybersecurity – Because of the type of information that cannabis companies handle, they can also become a prime target for hackers.

Despite the supply chain challenges mentioned above, the cannabis industry is growing, and its use is becoming more accepted in society, but still faces major challenges. These trends also will create a volatile and fast-changing environment cannabis companies in 2023. The big challenge will be deciding which of the scores of startups, IPOs and established cannabis companies can surmount the upheaval and succeed long term.

Q: How are companies mitigating risks and what tools are at its disposal?

Lott: Anyone involved in the cannabis/hemp business knows they need to manage their risk with a solid risk management plan.

The three biggest risks facing cannabis/hemp businesses aside from the supply chain issues mentioned above, include:

Employee theft – employees have easy access to the product, run cash registers at dispensaries, and generally know a lot about the inner workings of the company. Protecting against insider theft is critical for the business.
Product tampering – this can happen at any stage in the supply chain. Businesses whose products cause harm could be liable for injury and damages.
Compliance regulations – compliance varies from state to state and laws are frequently changing.

Thanks to regulatory uncertainty and limited access to tools other industries have access to, the cannabis industry likely will have an increased risk profile for the foreseeable future. This heightens the need for a structured, risk management approach. However, even with so many external factors out of its control, cannabis companies still can dramatically decrease risks by addressing internal strategies and processes.

Cannabis companies with effective, relevant, and well-documented risk management practices can better positioned to create and preserve capital, attract investment, and achieve long-term sustainable growth.

Jennifer Lott is speaking at the Supply Chain Risks in Hemp and Cannabis Webinar, taking place June 27 at 11:00 am EST. Click here to register.

About Jennifer Lott

Jennifer Lott is the AMAS Service Delivery Director for the internationally recognized standards certification body, BSI. Jennifer currently supports the quality and integrity of food and fast-moving consumer products. She is an accredited Lead Auditor and Trainer with over 25 years of experience in quality and safety, management system development, consulting, packaging, and laboratory management. Jennifer’s expertise includes GMP, ISO 22716, 21 CFR 117, 21 CFR 111, 21 CFR 210-111, ICH Q7, BRC GS Consumer Products, WHO GDP, EudraLex, BRC GS Storage & Distribution, BRC GS Packaging, BRC GS Agents & Brokers, RSPO, Food Safety, and GMP/HACCP.

Content Sponsored by BSI

May 24, 2023

Stemming the Tide: Strategies for Cannabis Testing Labs & Regulators to Address THC Inflation and Lab Shopping

By Arun Apte

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The cannabis industry in the United States is booming. In just a few years, it has gone from a small, underground market to a multi-billion-dollar industry. This growth is due in part to the legalization of cannabis in many states, as well as the growing public acceptance of its use for both medical and recreational purposes.

The industry is still in its early stages, but it has the potential to be a major economic driver for the United States. However, the industry’s success has brought with it challenges, such as THC inflation. This is when growers inflate the THC levels of their products in order to sell them for a higher price. This practice has led to widespread lab shopping, as growers send their products to labs that promise to give them the highest THC readings.

THC Inflation and Lab Shopping: A Look Under the Hood

Among cannabis enthusiasts, a prevailing belief circulates, asserting that cannabis products with elevated THC levels inherently possess greater potency and induce more pronounced effects. Nevertheless, this belief rests upon a fallacy, for it erroneously assumes that THC levels alone dictate the overall potency of a cannabis product. Genuinely comprehending the potency and effects of cannabis products requires the consideration of an array of factors. These factors include the presence of other cannabinoids and terpenes, the method by which the substance is consumed, as well as an individual’s metabolic and tolerance peculiarities. For instance, a particular strain of cannabis with low THC content, but elevated levels of other cannabinoids and terpenes, may engender a more intense impact in contrast to a variety exhibiting higher THC levels but diminished quantities of other compounds.

This misguided notion that heightened THC levels correspond to augmented potency has contributed to a surge in the demand for high-THC products. Consequently, producers have resorted to offering incentives to labs that provide inflated THC numbers for their products. Thus, certain labs have engaged in a practice coined as “lab shopping,” whereby they furnish reports that align with the producers’ desired THC levels, rather than accurately reflecting the genuine levels present within the product.

The manipulation of THC levels and the deceitful practice of lab shopping inflict profound damage upon the cannabis industry, eroding the foundation of trust. The fact that growers selectively collaborate solely with labs that yield desired outcomes, generates a mirage of superiority surrounding their products, thus deceiving consumers. Consequently, unsuspecting customers find themselves in possession of goods that fall far short of the promised standards of potency or quality. Moreover, this predicament places labs that remain steadfast in their commitment to integrity and the provision of accurate test results at an unfair disadvantage.

Fighting Back to Eradicate THC Inflation and Lab Shopping in the Cannabis Industry

The relentless surge of THC inflation finds its origins in the glaring absence of standardized testing protocols within the cannabis industry. As each lab embraces diverse methodologies and tools, testing produces disparate outcomes. This dissonance becomes a fertile ground for unscrupulous labs, who seize the opportunity presented by this lack of uniformity to peddle false THC numbers. To compound matters, the scope for manual interference looms large. The solution to this problem is to create a set of standards that everyone in the cannabis industry must follow. It’s important for the industry to come together and establish a common set of rules for testing. This will ensure that all labs consistently follow the same procedures and produce accurate results. In addition, it is important to have different labs take part in proficiency testing to find outlier labs. States should also take quick action to punish labs that provide incorrect or exaggerated THC values in their reports.

It is extremely important to prioritize transparency among labs in order to address the growing concerns regarding the inflation of THC potency. State regulatory bodies can achieve this by conducting frequent audits to detect and correct any inconsistencies or inaccuracies in the data. To make this possible, state agencies need to hire skilled data scientists who can thoroughly analyze the data produced by labs. If the industry collectively works towards addressing these issues, it will enhance consumer trust in the regulated market. By eliminating the incentives that drive THC potency inflation, a more trustworthy cannabis industry can take shape and flourish.

Next, it is crucial to educate customers about the false notion that higher THC levels always result in stronger effects. Through effective communication and raising awareness, the industry can address the issue of THC potency and discourage the practice of selectively choosing labs with desired results.

Finally, labs should achieve accreditation to ISO/IEC 17025 as evidence of their competence in producing trustworthy results. This will help restore customer trust in the regulated cannabis industry and establish a stronger system for quality assurance.

The Importance of Deploying a Cannabis Lab Testing Software

Having a Laboratory Information Management System (LIMS) is essential to meet the challenging ISO/IEC 17025 requirements. This system plays a critical role in providing an extra level of assurance and trust in the accuracy of lab results. By automating processes, integrating analytical instruments, and adhering to rigorous quality standards, a cannabis lab testing software minimizes the possibility of manual manipulation of test results.

Furthermore, a cannabis lab testing software maintains a sample chain-of-custody (CoC) through the sample life cycle and tracks samples using barcodes. Furthermore, it generates custom reports that include scannable QR codes, which can be instantly shared with customers. By configuring the QR code, it becomes possible to include a link to the original Certificate of Analysis (CoA) produced by a lab. This allows buyers to verify the reported composition on the product label by referring to the authentic test results on the CoA. This approach promotes transparency, trust, and accountability within the cannabis industry.

Tackling THC Inflation & Lab Shopping with Cannabis Lab Testing Software — Cannabis lab testing software to manage and track samples through their lifecycle and maintain a CoC (Figure courtesy CloudLIMS)

A cannabis lab testing software carefully monitors and records all activities, such as staff logins, document modifications, sample records, and test results, with a date and time stamp along with the name of the person who performed those activities. This thorough record-keeping process eliminates any chance of manual tampering with lab data, thereby enhancing the reliability and defensibility of test results. Moreover, the system effectively manages the outcomes of various Quality Control (QC) samples to guarantee accurate test results. By comparing the test results of QC samples with the samples being tested, the system can identify any analytical errors and enable lab managers to fix them, enabling labs to uphold quality standards.

The cannabis industry has experienced swift expansion as a result of cannabis legalization in multiple states across the United States. This has brought about various advantages, such as increased demand for cannabis products and the creation of new employment opportunities and tax revenue. However, the industry has faced challenges such as the issues of THC inflation and lab shopping. Dishonest producers and labs take advantage of the lack of standardized industry practices to deceive regulators and consumers. To address this issue, it is crucial to establish industry-wide testing standards that ensure consistency and accuracy across all labs. State agencies must also take prompt action to penalize labs that provide false THC values. Additionally, educating consumers about the misconceptions surrounding high THC levels and potency is important to combat this detrimental trend in the industry. Implementing cannabis lab testing software can help reduce the potential for human error and guarantee the authenticity and reliability of lab data.

This nascent but fast-growing industry holds remarkable promise for medicine and the economy, which can only be realized if proper safeguards are put in place and malpractices are stopped in their tracks.