Tag Archives: law

April 15, 2020

Processes, Protocols and Layers of Protection: Essential Security Measures for the Medical Cannabis and Hemp Industries

By Joshua Wall

As legalization of cannabis products from hemp to medical cannabis takes root across the U.S., there’s a growing need to understand and build good security practices. While many think of security as safeguarding assets like facilities and product, effective security does much more. It protects a business’ workers, providing them secure workplaces and incomes. Ideally, it reaches from supply chain to customers by ensuring consistently safe products.

To truly understand the value of this for a brand or for the industry as a whole, consider the opposite: the destructive effect – on a brand and on the industry at large – of unsafe or tampered product reaching customers, or of crimes occurring, just as the industry seeks to demonstrate its validity and benefits. Security is vital not only to individual farmers, processors or customers but to all who value what the industry brings to those who rely on CBD or medical cannabis products for their wellbeing.

Know the Threats.

Part of the learning process involves understanding the value of the product.Security is all about anticipating and reducing risks. These can include physical threats from natural sources – think flood, fire, tornado or crop fail – or from human threats. Human threats can arise from organized criminals, hackers, amateur thieves, vandals – or insiders.

As regulated industries, hemp and cannabis businesses also face risk of losses, which can be significant, from penalties ranging from fines to being shut down for non-compliance. While rules vary from state to state and continue to change, a disciplined approach to security is foundational to reducing risk at many levels. Rigorous operational processes must incorporate security that addresses risks at multiple points of access, transport and sale of products.

Learn the Rules.

In a rapidly evolving industry, one of the most important things producers can do is to learn. Security requirements vary by region and providers need to be aware of what is available. Get to know your state, local and federal resources for your operating area. California law, for example, specifies use of high-resolution video surveillance in dispensaries, while others do not.

Part of the learning process involves understanding the value of the product. With medicinal cannabis, it’s helpful to grasp both its commodity value and the street value that could make it attractive to thieves. In “Why Marijuana Plant Value is So Important for Adjusters,” Canadian Underwriter Magazine gave examples that indicate the size of losses that may occur in growing and processing operations:

“In the medical marijuana space, ClaimsPro has already seen losses primarily between $150,000 and $750,000. These losses, mostly on Vancouver Island, were for fire and water damage, as well as boiler machinery issues, physical damage to buildings and specialized greenhouse equipment, as well as extra expense and business interruption.”

The same article notes a claim over $20 million at another single flower greenhouse. Security needs to reflect what’s present on our premises.

Educating the community can reduce risk as well. Producers of industrial hemp may need to inform would-be thieves that what they are looking at is not street-valued product. To protect the crops, which are generally grown outdoors and do not require a full security detail, a best practice is simply posting signs on the property that say explicitly “No THC.”

Begin with a Risk Assessment.

Security begins with a professional evaluation of site vulnerabilities, examining key weaknesses that could be exploited by attackers. These include:

Monitoring access to the site is a foundational principle of security.
Design limited access points into the facility as well as prepare for possible facility breaches with perimeter access control, technological redundancies and ballistic glass for defensive architecture measures.
Look at route vulnerabilities as well.
Hedge site risk by not limiting your operation to a single site where one incident could wipe out an entire year’s crop.

The nature of threats is always changing. A 2018 Newsweek article described the struggles of legal cannabis farmers against illegal and potentially cartel-backed and violent operations in California. While a 2020 Business Insider report described indications that legalization was prompting some cartels to leave cannabis alone and move on to fentanyl and meth. “While Mexican drug cartels made their money predominantly from marijuana in past decades, the market has somewhat dissipated with the state-level legalization of cannabis in dozens of states across the US.”

Define Levels of Risk and Access.

The best security matches spending to risk in a commonsense way. Are you more at risk from the occasional smash and grab incident or is there reason to anticipate an organized assault? As in many industries, the greatest risk often comes from employee fraud or theft. Hiring carefully, paying fairly and training staff well are important to long term security.

Iron Protection Group in a training session
Image credit: Tampa Bay Times

How will the product be moved around within the facility and beyond it – and what staff are responsible for each part of the journey? Who can enter the cultivation areas and what protocols must they follow? On site staff should be trained on what to look for if they observe a security breach. Consider biometrics such as retinal scans, fingerprint scans or similar.

In cases where valuable product or cash is present, guards can play an important role. Harvest Connect uses only high-level former military or police officers in these roles, an approach recognized by many. Hunter Garth of Iron Protection Group notes they have “the ability to de-escalate a potentially harmful situation and the fortitude to see a mission through to completion, no matter what external circumstances may arise.”

Inventory and Transaction Controls

Inside threats from sloppy processes can be just as insidious as attacks. Poor tracking of inventory by Oregon’s legal cannabis producers made headlines in 2018 as The Oregonian reported, “U.S. Attorney Billy Williams told a large gathering that included Gov. Kate Brown, law enforcement officials and representatives of the cannabis industry that Oregon has an ‘identifiable and formidable overproduction and diversion problem.’’ Discipline, applied by state pressure but carried out by producers themselves, has begun to reduce the diversion of untracked product into the black market a year later.

Cannabis businesses need a professional approach to monitoring all product and money that moves through its systems. These operational processes can include time, date and attendance stamps on all inventory. Similarly, accounting systems and software must follow the highest professional standards. Lastly, when breaches occur, it is essential that fraud and theft are caught, eliminated and prosecuted as appropriate.

Nurturing an Emerging Industry

Security resources are an integral part of maintaining the integrity of a business’ supply chain. As the product moves from the fields to processing centers to consumers, purity assurance becomes an operational objective. Ultimately, protecting the product through secure and professional practices is the optimal way to serve customers, build a brand, and sustain the industry.

April 15, 2020

Perry Johnson Laboratory Accreditation (PJLA) Pivots to Virtual Assessments

By Cannabis Industry Journal Staff

No Comments

In a letter sent out to clients last week, Perry Johnson Laboratory Accreditation (PJLA) notified their partner labs that they will be conducting virtual assessments.

PJLA typically conducts assessments on-site. . However, given the current situation, with CDC recommendations for social distancing and mandatory stay-at-home orders in some states, the laboratory accreditation company is pivoting to virtual assessments to help their clients maintain accreditation.

Tracy Szerszen, president/operations manager, PJLA

Virtual assessments are not the norm, but they are allowed to offer them during crises where on-site assessments are not possible. PJLA is sending their clients virtual assessment surveys to check the viability of a remote assessment. That includes making sure there’s a video camera in the lab, capability to use remote meeting software, and capability for remote screen sharing during a quality review. Take a look at the letter PJLA sent their clients last week:

Dear PJLA Clients,

Considering the COVID-19 pandemic, business and the conduct of audits has changed dramatically. We at PJLA are doing all we can to maintain accreditation while keeping the health and safety of our auditors, our clients, and their families a priority.

To keep your accreditation valid, we have been able to implement Virtual auditing technology to do entire audits – or at least parts of audits – remotely, using virtual audit techniques. These types of audit are offered for crisis situations where we cannot perform routine on-site assessments (natural disasters, emergencies, travel restrictions).

Clients will be receiving a virtual assessment survey

Allowing for virtual (i.e. cameras in the lab)

Capability to use virtual systems

Having equipment with cameras/remote screen sharing for quality review and laboratory operations

Upon review of the survey, organizations and assessors will be provided with the decision that the assessment can be conducted fully or partially remote. Following approval, assessors and clients will have a discussion to determine the planning of the virtual assessment.

We have a team dedicated to providing support, but we still ask for your patience during this time. It may take some time for everyone to become comfortable with the software. We will be reaching out to each client to hear about their experience to continually improve this process.

We thank you for participating in this new and exciting assessment option.

Respectfully,

Tracy Szerszen

President/Operations Manager

Perry Johnson Laboratory Accreditation, Inc.

755 West Big Beaver Road Suite 1325

Troy, MI 48084

Phone: (248) 519-2603

www. pjlabs.com

April 14, 2020

New Zealand Proceeds With Medical Cannabis Program

By Marguerite Arnold

No Comments

For those looking for relief from bad news in general, whether it is about the pandemic, the economic meltdown or the impact of both on the cannabis industry, there is a glimmer of hope from the Kiwis this month.

On April 1, New Zealand’s Medical Cannabis Agency opened its application process for cultivation and manufacturing. Beyond sounding the starting gun for the race to local production and imports, the new rules also create a licensing framework that is aligned with international GMP (pharmaceutical grade) quality standards now becoming the norm globally for medicinally bound product.

It is good news for the industry, but it is good for a lot of other people too.

Doctors will be able to prescribe the drug more normally and for more conditions. And patents will have more access.

That said, this will also be a strictly “pharmacized” market for now with an emphasis on dose-controlled products like pills, oils and creams. Edibles are forbidden. And while dried flower will be allowed, smoking is strictly banned.

The license fees for cannabis start-ups are ridiculously low for those used to North American and even European pricing (all in for $7,409). But, even here, it is not a business for those without deep pockets and the right connections. The GMP certification required before such approvals are issued does not come cheap.

What Is Behind the Change?

This is not an overnight edict, obviously. And the wheels have been turning here since late 2018 when palliative patients were given limited access (basically a defence against criminal prosecution for possession). The medical cannabis scheme became law in December last year, allowing doctors to prescribe in limited situations.It remains to be seen if recreational will follow just six months later here.

In opening the licensing process, New Zealand’s health agency is keeping its word about rolling out the program on time. But unlike other jurisdictions, this first step in April is also part of a rolling agenda that will probably see more cannabis reform coming to Kiwis before the end of the year. This would be a lightning quick transition indeed for a country that as of November 2018, became the last country in the world to make hemp seed fully legal for human consumption.

Cannabis was completely outlawed in 1965. That said, it is estimated that about half a million New Zealanders still use the drug either medically or recreationally every year.

But reform is in the air. Lawmakers and policy makers have been looking at other recreational models for at least the last 12 months, including sending observers to Portugal last year to observe how this famously “open” European country has dealt with the issue.

Greater Reform A Possibility In September

This is not going to be all she wrote in New Zealand this year for cannabis reform. Legalizing the personal use of cannabis is being floated as a referendum on the same day as the 2020 General Election (September 19). The referendum may not pass, although support for the measure seems to be steadily rising. Currently about 59% of New Zealanders support medical use reform. A new poll seems to also show (as of March 31), that 54% of Kiwis might support personal recreational use.

No matter what happens, however, New Zealanders are just the next nation-state to admit that prohibition has roundly failed. 83% of New Zealanders believe that illicit cannabis is widely available anyway.

Regardless of the success of recreational reform, at least this fall, the medical market is likely to expand and the topic of greater reform is clearly in the air.

As always, no matter the geography, medical use comes first. It remains to be seen if recreational will follow just six months later here. Unless of course the general election itself is delayed because of the trailing end of the pandemic.

April 8, 2020

Cannabis Retailers Considered Essential: Safety Tips for Running Dispensaries During COVID19

By Aaron Green

No Comments

Dispensary sales in key US markets (CA, CO, WA, NV) remain up in Q1 2020 over Q1 2019, though the end of March saw sharp declines in sales according to a recent Marijuana Business Daily report. Massachusetts is also on track for record Q1 sales despite the closure of recreational stores, according to a recent BDS Analytics report.

budtenderpic — A bud tender helping customers at a dispensary

While it is still early to say what the impact of COVID-19 will be on dispensary sales into April, it is clear that the cannabis industry’s position as an ‘essential business’ is likely to help. States like Massachusetts are just allowing medical use businesses to remain open while states like California and Washington are allowing cultivators, producers and dispensaries to remain open. Meanwhile, according to Locate.AI’s analysis of retail traffic, the rest of the retail sector is down between 44% and 99% recently, depending on the category.

On March 24, the Washington State Liquor and Cannabis Board declared cannabis an essential industry including producers, processors and retailers. For dispensaries, they are now allowing curbside pick-ups for all adult customers. Colorado has gone further to restrict adult sales to curbside pick-ups only for recreational cannabis. Medical customers are still allowed to enter stores, but must practice social distancing. Across the states, dispensaries are offering curbside and in-store pick-up. In addition, at some dispensaries, delivery fees are being waived for larger purchases.

The International Chamber of Commerce recently published “Coronavirus Guidelines for Business,” summarizing actions businesses can take to reduce risks for operations and employees. Going further, The New England Complex Systems Institute (NECSI) recently published practical business safety guidelines detailing how these essential businesses can stay open and ensure safety. The guidelines, which are typically one to two pages and easily readable, are applicable to dispensaries. Certain suggestions, such as avoiding crowded spaces and maintaining 6ft distance will be familiar. Other suggestions go beyond common advice offering sensible recommendations to reduce risk of transmission as much as possible, such as the following:

“Consider setting up one or more ‘necessities only’ sections that enable a short shopping trip for most of the customers. Setting up such short shopping areas outside when weather permits, or at remote locations, can dramatically reduce the shopping density inside the store.” or

“Use floor markings or other visual system to indicate a one-way loop (with short cuts, but no back way) inside the store to promote a dominant walking direction and avoid customers crossing paths or crowding.”

While many cannabis businesses have already gone beyond recommendations from the local health authorities, there are some that would still benefit from adopting the NECSI Guidelines to further protect their customers and employees. The guidelines are written for laypeople and are easy to print and share.

NECSI’s coronavirus guidelines can be found on the group’s volunteer website endcoronavirus.org.

endCoronavirus.org is a volunteer organization with over 6,000 members built and maintained by the New England Complex Systems Institute (NECSI) and its collaborators. The group specializes in networks, agent-based modeling, multi-scale analysis and complex systems and provides expert information on how to stop COVID-19.

The New England Complex Systems Institute (NECSI) is an independent academic research and educational institution with students, postdoctoral fellows and faculty. In addition to the in-house research team, NECSI has co-faculty, students and affiliates from MIT, Harvard, Brandeis and other universities nationally and internationally.

April 8, 2020

Following Up: Questions From The Infused Products Virtual Conference Answered

By Ellice Ogle

No Comments

If you missed the Cannabis Industry Journal’s 3rd Annual Infused Products Virtual Conference last week, one of the speakers, Ellice Ogle, founder and CEO of Tandem Food presented on Food Safety Culture in the Cannabis Industry. An overview of the information in the presentation can be found here, Concentrate On a Food Safety Culture In Your Workplace. Below are answers to some of the post-presentation questions we received, but were unable to answer during the Q&A session. To get your additional questions answered or for a complimentary consultation for your company, specially provided to readers of Cannabis Industry Journal, contact Ellice Ogle at Ellice@tndmfood.com.

Question: What are some recommended digital programs for internal auditing?

Ellice Ogle: Before looking at the tools for conducting an internal audit, understand the goal of the internal audit. One key aspect of internal auditing is knowing which standard(s) to audit against. For example, regulatory audits for cGMP certification are different than optional third-party certifications such as any GFSI scheme (SQF, BRC, PrimusGFS, etc). While the standards ultimately have the same goal of food safety with varying focuses, it is important to have an experienced food safety specialist conduct the audit as realistically as possible. The experienced specialist will then be able to recommend an appropriate tool for internal auditing moving forward, whether it is software such as FoodLogiQ, SafetyChain, Safefood 360°, among many others, or simply providing a template of the audit checklist. Overall, the risk of foodborne illnesses can be minimal, but it takes persistence and commitment to achieve a successful food safety culture. Metrics can assist in assessing the commitment to food safety and, as a result of these efforts, you will minimize the risk of compromising the health and safety of your guests, employees, foods and business. If you want a specific example, I’d like to direct you to a case study in partnership with Heylo LLC in Washington state, posted on the Tandem Food website.

Q: What are examples of ways to share environmental monitoring results to enhance a good edible safety culture?

Ellice: In the Control of Listeria monocytogenes in Ready-To-Eat Foods: Guidance for Industry Draft Guidance (2017), the FDA states that “a well-designed environmental monitoring program promotes knowledge and awareness of the environmental conditions that could result in product contamination and is a more effective program than product testing alone.” In other words, environmental monitoring programs and results can identify environmental conditions within a facility that could cause potential contamination. Publishing these findings, for example in the form of a case study or sharing the details of the practice, can enhance the food safety culture in the specific niche industry. For example, to borrow from the meat industry, Tyson Foods, Inc developed and shared environmental monitoring programs that are used by their peers, promoting a unified food safety culture, rather than competitive, guarded secrecy.

Q: Are the food safety requirements the same for retail and manufacturing?

Ellice: The food safety requirements are not exactly the same for retailers and manufacturers. The difference is inherent that retailers are working with finished product while manufacturers are working with raw ingredients and the manufacturing process to develop the finished product. Let’s take a closer look at cannabis regulation in Washington state. Chapter 314-55-104(12) states “Processors creating marijuana extracts must develop standard operating procedures (SOPs), good manufacturing practices (GMPs), and a training plan prior to producing extracts for the marketplace.” Compare this to the requirements for retailers, 314-55-105(11) which states “A marijuana producer, processor or retailer licensed by the WSLCB must conduct the production, processing, storage, and sale of marijuana-infused products using sanitary practices.” While SOPs and GMPs are not explicitly mentioned for retailers as they are for manufacturers, sanitary practices could be documented as Sanitation Standard Operating Procedures (SSOPs). Proper storage practices can also be an overlapping food safety concern with respect to temperature control or pest management systems. Overall, food safety should remain a top priority in maintaining the integrity of the products throughout the supply chain.

Q: To your knowledge, has there been a food safety outbreak associated with a cannabis-based product?

Ellice: One possible cannabis-related death investigated in 2017 uncovered deadly pathogens in medical cannabis. However, to my knowledge, I have not seen a food safety outbreak associated with a cannabis-based product. There might be any number of reasons that this is so, for example, possibly because a food safety outbreak associated with a cannabis-based product might not have had a large impact to make headlines. Although, with the cannabis industry already misunderstood and a stigma so prevalent to even promote fake news, it is better to prevent an outbreak from ever occurring. One thing to note is that ultimately cannabis is just another ingredient in existing products, of course with special properties. So, the common food safety offenders are present: listeria, Salmonella, E. Coli, among others. On the plant, cannabis food product manufacturers must minimize the risk of mycotoxins produced by molds, pest contamination, and pesticide contamination. For products that contain cannabis infusions or extractions as an ingredient, there is the possibility of the growth of Botulism toxin. Many of these pathogens can be minimized by appropriate heat treatment or maintenance of refrigeration, testing, and by practicing preventive measures. Arguably, the largest potential for pathogenic contamination is due to improper employee handling. To refer to what we discussed earlier, employee training is key, as well as proper enforcement. Having a strong food safety culture ensures that people have the knowledge of food safety risks and the knowledge of preventing outbreaks.

Q: Do any of the panelists know of any efforts to develop a food safety-oriented standard for the cannabis industry?

Ellice: One example of a specific effort to develop a food safety-oriented standard for the cannabis industry includes TraceTrust A True Dose™ & hGMP™ certification. However, there are efforts for other standards that have food safety included. Take organic certification, there are several companies creating and auditing against their own standard such as Clean Green Certified, Oregon Sungrown Farm Certification, or Washington Sungrowers Industry Association. The California Department of Food and Agriculture (CDFA) is also preparing a cannabis program comparable to the USA National Organic Program.

Q: Can you assist with cGMP certification?

Ellice: Yes, Tandem Food LLC is positioned to consult on cGMP certification for manufacturing facilities in the cannabis industry. First, a gap assessment can be conducted to obtain useful actionable data for you, rather than be an intimidating experience. Working from the identified baseline, Tandem Food will work with you to create and implement all related documentation and programs, providing training as necessary. Overall, with the right commitment, cGMP certification can take 6-12 months.

April 7, 2020

FDA Says No, CBD Does Not Cure COVID-19

By Aaron G. Biros

4 Comments

Former NFL player Kyle Turley made headlines this week for some eye-catching remarks. The retired offensive lineman entered the cannabis industry in 2017, when he launched Neuro Armour (now called Neuro XPF), a brand of CBD products.

Turley and his Neuro XPF brand made claims in recent weeks, both on their website and in various social media posts on Facebook and Twitter, saying that their CBD products can cure COVID-19. Two quotes below, one from their website and one from a Facebook post, show how the company touted CBD as an effective medicine for treating COVID-19.

“Crush Corona . . . While scientists around the world are working 24/7 to develop a COVID-19 vaccine, it will take many more months of testing before it’s approved and available. However, there’s something you can do right now to strengthen your immune system. Take CBD . . . CBD can help keep your immune system at the stop of its game. . . . We want everyone to take CBD and take advantage of its potential to help prepare your body to fight a coronavirus infection. So, we’re making all of our products more affordable.”
“Crush Corona! Your best defense against the COVID-19 blitz starts with a strong immune system. It’s what protects your body from the everyday attacks of bacteria, viruses, parasites and a host of other nasties. Learn more here: https://neuroxpf.com/crush-corona/”

The U.S. Food & Drug Administration (FDA) got wind of these marketing tactics and sent Turley and his brand a warning letter. “FDA is taking urgent measures to protect consumers from certain products that, without approval or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people,” reads the warning letter. “As described below, you sell products that are intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. We request that you take immediate action to cease the sale of such unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.”

Before entering the cannabis space, Turley was diagnosed with chronic traumatic encephalopathy (CTE) and then early onset Alzheimer’s as a result of sustaining head injuries while playing in the NFL. Turley has a reputation for being an outspoken cannabis activist, crediting cannabis with improving his quality of life and eliminating the need for prescription opiates.

In a tongue-and-cheek response to the FDA, Turley posted the following on twitter: “OK OK, YOURE ALL RIGHT, ILL ADMIT IT! CHEAP CBD BRAND PRODUCTS WILL NOT PREVENT OR CURE COVID19!” Turley, making light of the situation, inserted the term “cheap” in there, almost challenging the FDA and disregarding their warning letter.

OK OK, YOURE ALL RIGHT, ILL ADMIT IT! CHEAP CBD BRAND PRODUCTS WILL NOT PREVENT OR CURE COVID19! @MarijuanaMoment

— KT (@KyleTurley) April 2, 2020

However, the FDA is not joking when they send these warning letters. According to the letter, Turley and his company have 48 hours to remediate the situation or face a federal court injunction.

April 7, 2020

Heightened EPL Exposure Hits Cannabis Businesses When Laying Off Employees

By Patrick Ryder

No Comments

Even though it’s valued at more than $15 billion, the burgeoning global cannabis industry has experienced recent layoffs. By the end of 2019, more than 600 cannabis employees got pink slips. Industry experts expect more of the same in 2020 as investigations, lawsuits and slumping valuations plague the industry.

Unfortunately for employers, layoffs are where the issues begin – not end. Especially for those without established policies and procedures. Without rules and regulations governing employment practices, business owners and operators are at considerable risk.

The 11 states where cannabis is legal for recreational use and the 33 where it’s medically legal tend to have more onerous employment practices liability (EPL) laws, where liability is often assumed by the employer for mistakes like poorly handled layoffs. This is further compounded by the fact that HR departments at fledgling cannabis companies tend to be small or non-existent and often ill prepared to deal with the legalities that come with termination.

Ensuring the right practices are in place prior to any layoffs is critical. Is your company facing employee terminations? Are you knowledgeable of how to handle it? Consider the following best practices:

Document problematic employees. Create a folder for each employee and document the details when problematic situations escalate to the point they need to be addressed. Should employees of a protected class engage in an EEOC, class action or personal lawsuit after they’re terminated, you’ll need this documentation to support your actions.
Create a formal termination procedure. Make sure the procedure includes well-thought-out details of your review process, including how employee performance is evaluated and what happens when those standards aren’t met. Spell out which behaviors are grounds for dismissal. When talking to the employee about a termination, have another employee or manager in the room to avoid claims of mishandling later on, typically their direct manager, someone from HR or your in-house attorney. Determine how the distribution of final compensation such as medical insurance or PTO will be handled so you’re prepared to answer those questions. These procedures should be spelled out in an employee handbook given to all at onboarding so there are no surprises.
Retain a qualified EPL attorney. Create a relationship with a qualified EPL attorney (not your cousin who does divorce law) to help you set policies and procedures initially and to consult with when a unique or particularly difficult situation arises.
Get the right EPL coverage. An EPL policy will defend a business from claims of breach of employment contraction, negligent evaluation, failure to employ or promote, wrongful termination, deprivation of career opportunity and mismanagement of employee benefits plans. Your EPL coverage will be determined by your location, clientele, employee profile and what you see as your biggest risks. When discussing the policy with your broker, weigh the following considerations to EPL coverage:
- Reimbursement coverage versus pay on behalf. Should the policy pay your defense costs directly, or will you lay out the money and they’ll reimburse?
- The definition of a claim and wrongful act will be different for each EPL policy.
- EPL policy’s limit structure. Do you want defense limits to be outside or inside the coverage?

Having to lay off employees is never an easy choice for an employer. Make sure you and your business do everything right before and during the process so that the aftermath isn’t even more difficult, filled with lawsuits and liability claims.

April 6, 2020

Cannabis Scientists and Labs Can Help with National COVID-19 Research Volunteer Database

By Aaron Green

No Comments

Harvard Neuroscientist, Michael Wells, and a team of volunteer scientists from endCoronavirus.org have created and stocked a national database of scientists and researchers ready, willing and able to help with response efforts for COVID-19. At the time of this writing, more than 8,000 scientists have registered from all 50+ states.

It all started with a Tweet on March 18th.

“I really wanted an outlet for me, like someone like me, to be able to help out in this fight,” Wells said in a Harvard Crimson interview. “I knew I was, by far, not the only one who felt this way. And so what happened was, on the walk home from work that day from the lab, I thought, ‘Hey, I should try to organize something here in Boston so I could potentially be a part of a group that makes themselves available to health department officials or county officials.’”

Volunteers are made up of a mix of laboratory scientists, data scientists, software engineers, medical writers, CEOs and epidemiologists – from academic research institutes, national labs and private industry. Many state and local government agencies and organizations have already accessed the list for reference, including FEMA.

Members of the cannabis industry can help to combat COVID-19. “The cannabis industry relies on specialized laboratories that routinely perform qPCR-based microbial tests,” says Wells. “As a result, these labs have basic skill sets and facilities required to participate in community COVID-19 testing.” Quantitative Polymerase chain reaction (qPCR), is a common technique for determining if there are microbial contaminants in flower, concentrates and infused products.

Some cannabis industry leaders have already taken to the call. “With the trend in legalization, the cannabis industry has built an excess testing capacity in anticipation of an increase in volumes,” says David Winternheimer, PhD, CEO of Pacific Star Labs, a Los Angeles-based cannabis research organization with an ISO-accredited testing laboratory. “As an essential industry, cannabis companies are open to helping the wider population in a crisis like this, and testing could easily be adopted in labs with excess microbial testing capacity.”

Michael Wells and his band of volunteers are asking to help get the word out to other scientists who would like to sign-up at https://covid19sci.org and for anyone to help share the database link with any relevant person in government or health services. “Right now, it is all hands on deck. We need every lab, facility, and pair of skilled hands to be deployed in this fight against the most dangerous pathogen our species has experienced at this scale in our lifetimes.”

The COVID-19 National Scientist Volunteer Database is a database of over 8,000 scientists from all 50 states, DC, Puerto Rico, and Guam who are eager to volunteer our time, expertise, equipment, and consumables to help you respond to the COVID-19 crisis. They have aggregated our contact information, locations, and skills sets into this easy to use centralized database. Their members include experts in scientific testing, bioinformatics, and data management, as well as key contacts willing to donate lab space and testing supplies.

April 3, 2020

Soapbox

(L)Earning from Failure

By Dr. Markus Roggen, Soheil Nasseri

No Comments

The spectacular rise and crash of the Canadian cannabis stock market has been painful to watch, let alone to experience as an industry insider. The hype around the market has vanished and many investors are left disappointed. Large sustainable gains simply haven’t materialized as promised. The producers are clearly suffering. They have consistently been shedding value as they’ve been posting losses every quarter. Stock prices have plummeted along with consumer confidence. Attempts to reduce the cash bleeds through mergers, acquisitions, layoffs, restructures, fund raises, among others, have not resulted in any significant recovery. In short, the current model of a cannabis industry has failed.

Dr. Markus Roggen, Founder of Complex Biotech Discovery Ventures (CBDV)

How could it have been different? What should the industry have done differently? What makes the difference between failure and success? A recent article published in Nature (Volume 575) by Yin et al. titled “Quantifying the Dynamics of Failure Across Science, Startups and Security” analyzes the underlying principles of success. The article studies success rates of many groups after numerous attempts across three domains. One of the domains being analyzed are startup companies and their success in raising funds through many attempts at investment acquisition. The authors point out that the most important factor that determines success is not relentless trying but is actually learning after each attempt. Learning allows successful groups to accelerate their failures, making minute adjustments to their strategy with every attempt. Learning behavior is also seen early in the journey. This means that groups will show higher chances of success early on, if they learn from their mistakes.

If you want to succeed, you need to analyze the current state, test the future state, evaluate performance difference and implement the improved state.

This also needs to happen in the cannabis industry. Producers have been utilizing inefficient legacy systems for production. They have shackled themselves to these inefficient methods by becoming GMP-certified too early. Such certifications prevent them from experimenting with different designs that would enhance their process efficiency and product development. This inflexibility prevents them from improving. This means they are setting themselves up for ultimate failure. GMP is not generally wrong, as it ensures product safety and consistency. Although, at this early stage in the cannabis industry, we just don’t yet have the right processes to enshrine.

How can cannabis producers implement the above-mentioned research findings and learn from their current situation? In an ever-changing business environment, it is companies that are nimble, innovative and fast enough to continually refine themselves that end up succeeding. This agility allows them to match their products with the needs of their consumers and market dynamics. booking.com, a travel metasearch engine, is the prime example of this ethos because they carry out thousands of experiments per year. They have embraced failure through rapid experimentation of different offerings to gauge user feedback. Experimentation has allowed booking.com to learn faster than the competition and build a stronger business.

Soheil Nasseri, Business Associate at Complex Biotech Discovery Ventures (CBDV)

At CBDV, we put the need for iterative experimentation, failure and improvements to achieve breakthroughs at the core of our company. We pursue data to guide our decisions, not letting fear of momentary failure detract us from ultimate success. We continuously explore multiple facets of complex problems to come up with creative solutions.

A good example of how failure and rapid innovation guided us to success is our work on decarboxylation. We were confronted by the problem that the decarboxylation step of cannabis oil was inconsistent and unpredictable. Trying different reaction conditions did not yield a clear picture. We realized that the most important obstacle for improvements was the slow analysis by the HPLC. Therefore, we turned our attention to developing a fast analysis platform for decarboxylation. We found this in a desktop mid-IR instrument. With this instrument and our algorithm, we now could instantaneously track decarboxylation. We now hit another roadblock, a significant rate difference in decarboxylation between THCA and CBDA. We needed to understand the theoretical foundation of this effect to effectively optimize this reaction. So, we moved to tackle the problem from a different angle and employed computational chemistry to identify the origin of the rate difference. Understanding the steric effect on rate helped us focus on rapid, iterative experimentation. Now, with everything in place, we can control the decarboxylation at unrivaled speeds and to the highest precision.

If producers want to regain the trust of the market, they must embrace their failures and begin to learn. They should decrease their reliance on inefficient legacy production methods and experiment with new ones to find what is right for them. Experimentation brings new ways of production, innovative products and happier customers, which will result in higher profits. Producers should strive to implement experimentation into their corporate cultures. This can be done in collaboration with research companies like CBDV or through development of inhouse ‘centers of excellence.’

March 31, 2020

Soapbox

Home Office HACCP During COVID-19

By Nathan Libbey

1 Comment

With much of the world shutting down and many of us forced to take refuge behind our own doors, we have some time to reflect on what actions led to this. There has been, in my opinion, a clear disconnect between our actions and health outcomes. We need to bridge this gap; We now have a moment to build that bridge. We can start by reassessing our endpoint measurement of health and disease and focusing on what leading measures will impact our lagging results. Think of it as HACCP-lite or home office HACCP. Small changes in the way we think and behave can lead to significant change.

Lagging measures – Lagging measures make great headlines and typically measure an outcome. These are easily quantifiable and therefore receive a good deal of the focus.

Leading measures – Leading measures are inputs that happen during the process and in advance of an outcome. Leading measures are often difficult to quantify.

This week, Nathan started a “Germ Jar” activity with his kids to track washing.

We are currently focused on the lagging measures for a communicable disease, COVID-19. Illness and death numbers stemming from the pandemic continue to rise, as is expected with more available testing. It is easy for us to dwell on these numbers as they climb and dominate the news. A study in Australia last decade indicated that just over 1% of those experiencing flu like symptoms sought treatment and eventually got tested. I’m not going to use the tip of the iceberg cliché, but there it is. Focusing on the rapidly rising rates of COVID may be easy to do, but it won’t help our future selves.

What we should be doing during this time, however, is looking at our own leading behaviors and how changing them can help prevent this situation from reoccurring.

Here are some inputs we can rethink:

Hand washing – The average American uses the restroom 6-7 times per day. This week I started a “Germ Jar” activity with my kids (spring break week!) to track washing. If we wash our hands every time we use the restroom and every time we eat, that’s roughly 10X per day. Our leading indicator of household health, then, is 10 hand washes per day. This principle can, and should be applied to workplaces, including schools, airports and hospitals. What if we had mandatory handwashing prior to airport security and boarding? My estimation is that data would indicate a sharp decline in illness and transmission rates.
Disinfecting/Sanitizing – Similar to hand washing, cleaning surfaces serves as a vital indicator of future health. Examples, such as this District in Freeport, Il, indicate that increasing frequency of disinfecting can lead to a dramatic decrease in numbers sick. In my new office setting, we have set a goal via the Germ Jar of 3 times per day wiping down high touch surfaces. As we reenter close-proximity society, we need to have a better understanding of what high touch surfaces are, both for those who are tasked to clean them, as well as those that are doing the touching. Reduction of touches coupled with above washing behaviors post-touch can help prevent disease transmission.
Nathan’s daughter adding to the Germ Jar
Monitoring – Lastly, we need to do a better job at monitoring ourselves and our environments. In my new office, we have enacted a temperature check every morning and night. If we practiced symptom reporting (coughing, sneezing, chills) and monitored temperature in other settings, such as offices and schools, could we start to see pockets of infection and trends? Taking it a step farther, while we invest a tremendous amount of time and money into protecting our food supply from foodborne illness, we rarely discuss preventive monitoring for other diseases, such as influenza and now COVID-19. Technologies are rapidly coming available that will allow us to perform quick diagnostics of both individuals and environments. If we were to monitor the air and surfaces of a school nurse’s office, would we find data that could prevent transmission of disease? Can we transfer HACCP-lite to additional (all) settings?

Over the next weeks and months, we are going to be inundated by the spike in COVID illnesses and deaths. During this time, it is on each of us to realize how our past behaviors led to the state we are in. When we return, viruses will not be absent from the world, our hospitals, schools, offices or our bodies. We can, starting now, begin to measure and change our leading behaviors and begin to shape a healthier future.