Tag Archives: cannabis

September 23, 2019

Alcaliber Spinoff Linneo Health Gets Greenhouse GMP Certification In Spain

By Marguerite Arnold

As the industry faces what is undoubtedly a watershed moment for the international cannabis vertical, a new Spanish firm steps into the market with its own EU GMP certification license. Linneo Health is also helmed by the ever eloquent and highly experienced Jose Antonio de la Puente – a tall drink of water with a conscience, a brain and an admirable mission statement.

As Cannabis Industry Journal broke in our last story, a lack of international standards in Europe have been on trial of late. The same day that the CannTrust scandal began to blow in Canada and as Danish authorities rang global alerts, the only qualified packager in Holland was issued a new EU GMP cert. That is a government decision, not a commercial one.

This also implies, at minimum, government lack of coordination and agreement on EU GMP cert even between European nations, for a nascent industry while also trying to avoid the thorny issue of patient home grow. See also the trials and travails of the erstwhile German cultivation bid and its reconstituted Frankenstein-esque bigger if younger sister. In fact, this contretemps is almost certainly involved if not indirectly to blame.

Not All Is Entirely Rosy On Cannabis Europe’s Eastern Front

Almost simultaneously to Linneo Health’s announcement, however, the news came that in Poland, authorities had suspended the pending product registration process. Will this be on hold until after the October election?

In this environment it is almost impossible to know.

Here is one thing to consider. These almost simultaneous developments in Spain and Poland and the newest announcement about further certification of the Dutch recreational system under a new pending “recreational trial” are almost directly related.

That said, even such political maneuverings are not new – and far from limited to any single company. Both Germany and Poland have been wracked by reform stuttered by short term gain and market entry strategies executed by most of the biggest players in the room. Aurora, for example, announced their first import into Poland the same day the Polish government changed the law last fall. Aurora uses Germany as its breakpoint distribution center for Europe.

A Stamp of Authenticity That Is Sorely Needed

Beyond the pharma and market entry politics, however, this Alcaliber-helmed project creates a ring of authority to the same that creates at least one cannabis brand the European medical community can see the certification for.

For now at least, certainly among the ranks of the upper echelons of the international cannabis industry, there must surely be a sigh of relief.

EU GMP certifications (in other words, the authorization to produce product bound for a medical, pharma market) do not happen overnight. On the European front, this is surely at least a step in the right direction for an industry embattled by scandals, particularly of the securities, production, certification and accounting kind right now.

In this case, however, it is also clear that no matter the egregious oversteps and potentially illegal and certainly dubious behaviour of some members of the industry, there are also clearly those within it, and at high levels, who have tried to do the right thing. And further, from the beginning of the nascent industry here as of 2015.

Who Is Alcaliber?

Alcaliber is one of the world’s largest opioid manufacturers. Unlike American counterparts, the company decided several years ago to invest in and back ideas of the opioid-to-cannabinoid therapy model. Linneo Health is a 60% subsidiary of Alcaliber and 40% owned by a Spanish family office called Torreal, S.A.

This is, as a result, one of the most important GMP licenses in Europe at the moment if not the world. It means that within a pharmaceutical environment, the first widespread research and production of plants and therapies for those suffering from both chronic pain, plus neurological and oncological conditions that cause or are related to the same, will be put on a fast track long in the offing. Certainly in Europe.

And that for one, is a positive development that will have widespread implications elsewhere. Particularly given the news that the opioid epidemic in the United States finally has a name, and culpable parties.

What Else Is Unusual About This Project?

GMP certification is a vastly misunderstood concept at the moment. It is also a highly thorny one because of a still standardizing set of agreements. The regulatory environment is in place, in other words, but there are many, many gaps, as well as shifting rules and underlying treaties.

However, on top of this, there is also an amazing lack of innovation in interpretation, in part because of many misadvised consultants who are actually seeking to “save” production costs for their clients, or because they do not know any better. Or because producers are scared of doing the wrong thing.

The new project in Spain is unusual because it is a greenhouse grow that got EU GMP cert – although look for more of this in the future. It means that with careful, standardized, pharma production, not all regulated cannabis grows, even for the medical market, have to use huge amounts of energy in repurposed post-industrial developments. It is also certainly cleaner than growing outside. And, when done right, saves huge amounts of water.

Cleantech, in other words, has finally hit the cannabis industry in Europe. As well as a pharmaceutical company invested in the cannabinoid treatment of (at least) chronic pain.

That is an overdue and hugely positive development. No matter what else can be said for shenanigans engulfing the rest of the industry at the moment.

September 20, 2019

How to Properly Store Plastic Cannabis Packaging

By Danielle Antos

No Comments

Your plastic cannabis packaging has a big responsibility. It contains and protects your product, communicates pertinent product information and delivers the first brand impression to your consumers. In order for plastic packaging to fulfill these important roles, you must take care to store and handle it properly.

Following storage condition requirements for plastic bottles helps protect your cannabis product, your company and your customers. It doesn’t matter if your cannabis packaging is HDPE (high density polyethylene), PP (polyethylene) or PET (polyethylene terephthalate), proper storage is imperative to maintain the integrity of the product until you’re ready to fill it.

Bottle and closure storage conditions such as time, temperature and humidity can have an effect on plastic containers. The exposure and age of a sample can also affect shrinkage, impact properties and the stress crack resistance of the container. Not to mention the potential threat of contamination to your cannabis product and the poor impression of your brand in the eyes of your consumers.

You may be wondering how to obtain storage information. The best place to start is with your cannabis packaging partner. Your supplier should be ready and willing to share all vital storage information with you. The best suppliers realize that there is more to a business relationship than just the financial transaction of buying packaging. The first step in proper storage is to identify the type of material that was used to manufacture your bottles and closures.

Know Your Bottle Material Type – HDPE

If you are utilizing HDPE for your cannabis packaging, the storage time should be minimal and a strict first-in-first-out inventory should be maintained. Many end users will re-approve bottles after two or three years to ensure they are damage-free.

In addition, elevated storage temperatures allow plastic containers to further shrink and harsh conditions can actually cause severe distortion. The degree of distortion and shrinkage depends on the design and how the bottles have been stored. Higher storage temperatures also accelerate the aging process of the container. A moderate storage temperature should be provided to safeguard consistent bottle dimensions and properties. It is routinely reported that HDPE bottles can withstand temperatures of 110^°F/33°C for brief periods.

Although humidity itself will not degrade the plastic container, a humid environment can have a direct impact on the secondary packaging, such as the cardboard cartons used for shipping. If you use stretch wrap and/or control warehouse conditions, secondary packaging problems can be alleviated.

HDPE bottles and closures should be kept as clean as possible – it is best to leave them in the original sealed cartons. The storage area should be kept clean, dry and dust, odor, insect, and rodent-free. Following this rule will help to build consumer trust in your brand. No one wants to purchase cannabis products in dirty, dusty contaminated packages.

Using PET Bottles?

PET bottles should also be used in a first-in-first-out system to limit the time in storage. Long-term storage should be accomplished using a sealed polyethylene plastic bag or lined drums, totes, bins, Gaylord containers, supersacks or seabulks. The plastic liner will help prevent dust and dirt from entering the bottles.

Elevated storage temperatures (above 100^°F/38^°C) allow empty PET bottles to shrink, mainly due to relaxation of the oriented and partially oriented regions of the bottle. Extreme temperature conditions (above 131^°F/55^°C) can cause severe distortion of the amorphous areas of the bottle, including the finish and neck. Moderate storage temperature should be maintained to ensure consistent bottle dimensions and properties.

To help protect PET bottles from contamination, the storage area should be kept clean, dry and dust, odor, insect, and rodent-free. Additionally, the storage area should be approved for food storage. PET bottles should not be stored in direct sunlight, and aromatic materials such as spices, solvents, ink, cleaning supplies and disinfectants should not be stored in the same area.

When empty PET bottles are shipped to or through areas where the outdoor temperature may exceed 90°/32°C, it is recommended that a temperature-controlled container or trailer capable of maintaining a temperature of 80°F/27°C or lower be used.

Polypropylene (PP) Closures

Closures are also an important part of your cannabis packaging. The storage time of unlined closures should be minimized. As with bottles, a strict first-in-first-out inventory should be maintained.

Elevated storage temperatures allow unlined PP closures to further shrink. Harsh conditions can actually cause severe distortion. The degree of distortion and shrinkage depends on the closure design and storage conditions. High storage temperatures accelerate the aging process of the closure; moderate storage temperatures should be provided to ensure consistent closure dimensions and properties. Like HDPE bottles, this type of closure can withstand temperatures of 110°F/43°C for brief periods.

When stored in humid conditions, pay attention to the integrity of the cardboard cartons the closures are stored in. The use of stretch wrap and/or controlling warehouse conditions will help alleviate damage to the cardboard. Just like their bottle counterparts, PP unlined closures should be kept as clean as possible and it is best to store in original sealed cartons.

Proper Storage Supports Your Bottom Line

Storing plastic bottles improperly can reduce the integrity of the plastic, therefore making it unsuitable to contain your cannabis product. Poor storage can also be detrimental to filling lines and cause production problems, which can result in reduced efficiencies and added costs.

Product recalls can also be a by-product of poor storage due to increased chances of product contamination. If plastic bottles and closures are not properly stored before using, distortion and shrinkage can damage the bottle labels used to identify your product. Shrinkage of your plastic closures result in a poor sealing surface which is detrimental to the freshness of your cannabis product. All of these side-effects can be very damaging to your brand image, from which it’s hard to recover. Consumers will lose confidence in your brand – leading to reduced profits for your bottom line.

Whether your cannabis business is in the early start-up stages or established with loyal customers, properly storing your plastic packaging will help protect your brand, decrease the risk of product recalls and increase your profitability.

September 19, 2019

Soapbox

The Stress of a Grower

By Carl Silverberg

2 Comments

Tell me that you can’t relate to this story.

You’re sitting down to dinner at a restaurant about ten minutes from where you work, finally relaxing after a tough day. You’ve set your environmental alerts on your plants; you have that peace of mind that the technology promised and you know that if anything goes wrong you’ll get notified immediately. As you’re looking at the menu, you receive an alert telling you that the temperature in one of your 2,000 square foot grow rooms has gone out of the safe range. Your mind starts to race, “It’s week seven, I’ve got 500 plants one week away from harvest, that’s 200 pounds of cannabis worth about $150,000-$200,000. Oh my God, what am I going to do?”

You’re doing all this at the dinner table and even though you’re not in a state of panic, you are extremely concerned. You need to figure out what’s going on. You check the graphing and see that over the past hour your humidity dropped and your temperature is gradually going up. Within the past ten minutes, the temperature has gone to 90 degrees. Your numbers tell you that the temperature in the room with $200,000 of cannabis is going up about five degrees every three minutes.

adamJgrow — Monitoring a large grow room can be a stressful task.

“I see this trend and can’t figure it out,” the grower relates. “Normally, the HVAC kicks on and I’d begin to see a downward trend on the graphs. I pre-set my trigger for 90 degrees. But, I’m not seeing that. What I AM seeing is the temperature gradually and consistently getting warmer without the bounce-back that I would expect once the HVAC trigger was hit. All I know is I better find out what’s causing all this and I better find out fast or my entire crop is gone.”

You go through the rest of the checklist from LUNA and you see that the lights are still on. Now, you’re starting to sweat because if the temperature in that room hits 130 and stays there for more than twenty minutes, you’re losing your entire crop. You have to walk in your boss’s office the next day and explain why, after all the time and money you put in over the past seven weeks, not only is all that money gone but so is the $200,000 he is counting on to pay salaries, expenses, and bank loans.

This is something you’ve been working on for seven straight weeks and if you don’t make the right decision, really quickly, when that room hits 130 degrees here’s what happens.

“My equipment starts to fail,” our grower continues. “The crop literally burns as the oils dry up and the crop is worthless. At 130 degrees, my grow lights essentially start to melt. All you can think of is that temperature going up five degrees every three minutes and you’re ten minutes from your facility. I need to leave that restaurant right now, immediately, because even if I get there in ten minutes the temperature is going to be almost 120 degrees while I’ve been sitting here trying to figure out what’s wrong.”

You run out to your car and you speed back to the facility. The grow room is now 125 degrees, you have maybe three or four minutes left to figure things out before you flush $200,000 down the drain. The first thing you do is turn off the grow lights because that’s your primary source of heat. Then, you check your HVAC panel and you realize it malfunctioned and shorted out. There’s the problem.

The real toll is the human cost. Once this happens, no grower ever wants to leave and go home or even go to dinner. It’s a horrible toll. It’s the hidden cost we don’t talk about. The grower opens up with his own personal experience.“This system allows the grower to step back and still feel confident because you’re not leaving your facility to another person,”

“You think about the burden on the person that you bring in to replace you while you’re out of town and then you think about the burden on you if something goes wrong again. And you decide, it’s not worth it. The anxiety, the fear that it will happen again, it’s not worth it. So, you don’t go. I didn’t even see my sister’s new baby for eight months.”

Your desire to see your family, your desire to have a normal life; all of that goes out the window because of your desire to be successful in your job. It outweighs everything.

This is every grower. It’s why many farmers never leave their property. It just becomes a normal way of living. You just repeat it so much that you don’t even think about it. Why go on vacation if your stress level is higher than it is if you’re home. You’re constantly worried about your farm or your facility. The only way to escape it is to not go away at all.

“This system allows the grower to step back and still feel confident because you’re not leaving your facility to another person,” he tells us. “You don’t realize how stressful a lifestyle you live is until you step back and look at it. Or, if you have an alert system that allows you to pull back. That’s when you realize how difficult your life is. Otherwise, it just seems normal.”

As AI technology expands its footprint into agriculture, there will be more tools to help mediate situations like this; more tools to give you a more normal life. It’s one of the reasons we got into the business in the first place.

September 19, 2019

Biros' Blog

Tuesday, September 24th is National Voter Registration Day

By Aaron G. Biros

No Comments

In an interview with HeadCount back in 2012, Bob Weir, founding member of the Grateful Dead, discussed the importance of registering to vote. “Just register, study up and vote. It’s your future. Don’t let people take that from you,” says Weir. “Cause in years to come you’ll be wishing you had.”

Tuesday, September 24th is National Voter Registration Day and we want to remind our readers to register to vote. If you subscribe to our newsletter, read our articles, news stories, columns and features, then chances are that you support legal cannabis. If you are supportive of legal cannabis, then you should consider voting for candidates that support the same cause. Cannabis legalization is about more than just creating a legal marketplace; it’s about social justice, equality, civil rights and more. If you can heal the symptoms, but not affect the cause, it’s quite a bit like trying to heal a gunshot wound with gauze.

Bob Weir, founding member of the Grateful Dead
Image: jgullo, Flickr

The 2020 election is approaching faster than you think and choosing candidates that support legal cannabis is a quick and easy way to help. We really like what the Cannabis Voter Project (CVP) is up to. CVP is a nonprofit initiative started by HeadCount, an organization that promotes voter registration and participation in democracy through the power of music. This past summer, CVP went on tour with Dead & Co., engaging with concertgoers about registering to vote. Headcount has helped about 600,000 people register to vote so far. Bob Weir sits on their board of directors. Bands like Phish, Jay-Z, Dave Matthews, Pearl Jam have also helped get the word out about registering to vote as a part of HeadCount’s campaign.

You can register to vote or check your voter registration status by clicking here. You can also text CANNA to 40649 to contact your lawmakers and ask where they stand on cannabis. Once in a while you get shown the light, in the strangest of places if you look at it right. At the CVP’s website, you can check out their database of congress, organized state-by-state, with each members’ stance on cannabis.

Their advisory board features cannabis companies like CannaCraft, Terrapin Care Station, Harvest, Sal Pace Consulting, 1906 and Vicente Sederberg. They went on tour with funk band Lettuce to educate the band’s fans about what’s going on with cannabis policy in their state and how they can use their vote to impact cannabis policy.

Cannabis is a bipartisan issue. The cannabis voting bloc is bigger than you think and we have the power to make change happen by making our voices heard. “HeadCount is not so much political, it’s nonpartisan,” says Weir. “What we’re trying to do is get kids to register, pay attention to what candidates are saying, pay attention to the politics of the moment, and react with their hearts and minds.”

The cannabis legalization movement has made serious progress recently, but we still have to just keep truckin’ on.

September 17, 2019

A2LA Accredits First Labs in Tennessee and Oklahoma

By Cannabis Industry Journal Staff

No Comments

According to a press release published earlier this week, A2LA announced the accreditation of two separate cannabis laboratories in two separate states; both are the first cannabis testing labs accredited in their states. Demeter Laboratory, based in Oklahoma City, Oklahoma, and Galbraith Laboratories, based in Knoxville, Tennessee, achieved the ISO 17025:2017 accreditation.

According to Cassy VanTassel, M.S., quality manager at Demeter Laboratory, Oklahoma is still developing and defining their regulatory framework for cannabis testing requirements. “Even though the State of Oklahoma is still establishing regulations and legislation, Demeter will always strive to meet the highest quality standards, so our customers know they are getting the best quality testing,” says VanTassel. “Demeter chose A2LA as its Accreditation Body due to their reputation in the industry, their diverse clientele, and the quality of their assessors.”

In Tennessee, Galbraith Labs is looking to aid the hemp industry in product safety testing. Christy Myers, customer service manager at Galbraith Laboratories, says they want to help farmers produce safe hemp products. “We are proud of our commitment to stay current within our industry and achieve the high standards set by A2LA,” says Myers. “Adding cannabis testing to our line of services was a great opportunity for Galbraith Laboratories to serve the community by helping farmers produce safe and legal hemp.”

Galbraith Labs was founded in 1950 as a contract lab in Knoxville serving many industries. With their newly established accreditation, they hope to aid the cannabis industry in Tennessee with hemp testing. Demeter Laboratory is the first medical cannabis lab in Oklahoma. Their goals include “advancing quality controls in medical cannabis, supporting safe consumption of cannabis and ensuring the transparency of the cannabis community.”

September 17, 2019

Fungal Monitoring: An Upstream Approach to Testing Requirements

By Bernie Lorenz, PhD

1 Comment

Mold is ubiquitous in nature and can be found everywhere.¹ Cannabis growers know this all too well – the cannabis plant, by nature, is an extremely mold-susceptible crop, and growers battle it constantly.

Of course, managing mold doesn’t mean eradicating mold entirely – that’s impossible. Instead, cultivation professionals must work to minimize the amount of mold to the point where plants can thrive, and finished products are safe for consumption.

Let’s begin with that end in mind – a healthy plant, grown, cured and packaged for sale. In a growing number of states, there’s a hurdle to clear before the product can be sold to consumers – state-mandated testing.

So how do you ensure that the product clears the testing process within guidelines for mold? And what tools can be employed in biological warfare?

Mold: At Home in Cannabis Plants

It helps to first understand how the cannabis plant becomes an optimal environment.

The cannabis flower was designed to capture pollen floating in the air or brought by a pollinating insect.

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

Once a mold spore has landed in a flower, the spore will begin to grow. The flower will continue to grow as well, and eventually, encapsulate the mold. Once the mold is growing in the middle of the flower, there is no way to get rid of it without damaging the flower.

A Name with Many Varieties

The types of spores found in or around a plant can make or break whether mold will end with bad product.

Aspergillus for example, is a mold that can produce mycotoxins, which are toxic to humans². For this reason, California has mandatory testing³for certain aspergillus molds.

Another example, Basidiospores, are found outside, in the air. These are spores released from mushrooms and have no adverse effects on cannabis or a cannabis cultivation facility.

Fungi like powdery mildew and botrytis (PM and Bud Rot) typically release spores in the air before they are physically noticed on plants. Mold spores like these can survive from one harvest to the next – they can be suspended in the air for hours and be viable for years.

How Mold Travels

Different types of spores – the reproductive parts of mold – get released from different types of mold. Similar to plants and animals, mold reproduces when resources are deemed sufficient.

The opposite is also true that if the mold is under enough stress, such as a depleting nutrient source, it can be forced into reproduction to save itself.⁴

In the end, mold spores are released naturally into the air for many reasons, including physical manipulation of a plant, which, of course, is an unavoidable task in a cultivation facility.⁵

Trimming Areas: A Grow’s Highest Risk for Mold

Because of the almost-constant physical manipulation of plants that happen inside its walls, a grow’s trimming areas typically have the highest spore counts. Even the cleanest of plants will release spores during trimming.

These rooms also have the highest risk for cross contamination, since frequently, growers dry flower in the same room as they trim. Plus, because trimming can be labor intensive, with a large number of people entering and leaving the space regularly, spores are brought in and pushed out and into another space.

The Battle Against Mold

The prevalence and ubiquitous nature of mold in a cannabis facility means that the fight against it must be smart, and it must be thorough.

By incorporating an upstream approach to facility biosecurity, cultivators can protect themselves against testing failures and profit losses.

Biosecurity must be all encompassing, including everything from standard operating procedures and proper environmental controls, to fresh air exchange and surface sanitation/disinfection.

One of the most effective tactics in an upstream biosecurity effort is fungal monitoring.

Ways to Monitor Mold

Determining the load or amount of mold that is in a facility is and always will be common practice. This occurs in a few ways.

Post-harvest testing is in place to ensure the safety of consumers, but during the growing process, is typically done using “scouting reports.” A scouting report is a human report: when personnel physically inspect all or a portion of the crop. A human report, unfortunately, can lead to human error, and this often doesn’t give a robust view of the facility mold picture.

Another tool is agar plates. These petri dishes can be opened and set in areas suspected to have mold. Air moves past the plate and the mold spores that are viable land on the dishes. However, this process is time intensive, and still doesn’t give a complete picture.

Alternatively, growers can use spore traps to monitor for mold.

Spore traps draw a known volume of air through a cassette.⁶The inside of the cassette is designed to force the air toward a sticky surface, which is capable of capturing spores and other materials. The cassette is sent to a laboratory for analysis, where they will physically count and identify what was captured using a microscope.

Spore trap results can show the entire picture of a facility’s mold concerns. This tool is also fast, able to be read on your own or sent to a third party for quick and unbiased review. The information yielded is a useful indicator for mold load and which types are prevalent in the facility.

Spore Trap Results: A Story Told

What’s going on inside of a facility has a direct correlation to what’s happening outside, since facility air comes infromthe outside. Thus, spore traps are most effective when you compare a trap inside with one set outside.

When comparing the two, you can see what the plants are doing, view propagating mold, and understand which of the spore types are only found inside.

Similar to its use in homes and businesses for human health purposes, monitoring can indicate the location of mold growth in a particular area within a facility.

These counts can be used to determine the efficacy of cleaning and disinfecting a space, or to find water leaks or areas that are consistently wet (mold will grow quickly and produce spores in these areas).

Using Spore Traps to See Seasonality Changes, Learn CCPs

Utilizing spore traps for regular, facility-wide mold monitoring is advantageous for many reasons.

One example: Traps can help determine critical control points (CCP) for mold.

What does this look like? If the spore count is two times higher than usual, mitigating action needs to take place. Integrated Pest Management (IPM) strategies like cleaning and disinfecting the space, or spraying a fungicide, are needed to bring the spore count down to its baseline.

For example, most facilities will see a spike in spore counts during the times of initial flower production/formation (weeks two to three of the flower cycle).

Seasonal trends can be determined, as well, since summer heat and rain will increase the mold load while winter cold may minimize it.

Using Fungal Monitoring in an IPM Strategy

Fungal monitoring – especially using a spore trap – is a critical upstream step in a successful IPM strategy. But it’s not the only step. In fact, there are five:

Identify/Monitor… Using a spore trap.
Evaluate…Spore trap results will indicate if an action is needed. Elevated spore counts will be the action threshold, but it can also depend on the type of spores found.
Prevention…Avoiding mold on plants using quality disinfection protocols as often as possible.
Action…What will be done to remedy the presence of mold? Examples include adding disinfection protocols, applying a fungicide, increasing air exchanges, and adding a HEPA filter.
Monitor…Constant monitoring is key. More eyes monitoring is better, and will help find Critical Control Points.

Each step must be followed to succeed in the battle against mold.

Of course, in the battle, there may be losses. If you experience a failed mandatory product testing result, use the data from the failure to fix your facility and improve for the future.

The data can be used to determine efficacy of standard operating procedures, action thresholds, and other appropriate actions. Plus, you can add a spore trap analysis for pre- and post- disinfection protocols, showing whether the space was really cleaned and disinfected after application. This will also tell you whether your products are working.

Leveraging all of the tools available will ensure a safe, clean cannabis product for consumers.

References

ASTM D8219-2019: Standard Guide for Cleaning and Disinfection at a Cannabis Cultivation Center (B. Lorenz): http://www.astm.org/cgi-bin/resolver.cgi?D8219-19
Mycotoxin, Aspergillus: https://www.who.int/news-room/fact-sheets/detail/mycotoxins
State of California Cannabis Regulations: https://cannabis.ca.gov/cannabis-regulations/
Asexual Sporulation in Aspergillus nidulans (Thomas H. Adams,* Jenny K. Wieser, and Jae-Hyuk Yu): https://pdfs.semanticscholar.org/7eb1/05e73d77ef251f44a2ae91d0595e85c3445e.pdf?_ga=2.38699363.1960083875.1568395121-721294556.1562683339
ASTM standard “Assessment of fungal growth in buildings” Miller, J. D., et al., “Air Sampling Results in Relation to Extent of Fungal Colonization of Building Materials in Some Water Damaged Buildings,” Indoor Air, Vol 10, 2000, pp. 146–151.
Zefon Air O Cell Cassettes: https://www.zefon.com/iaq-sampling-cassettes

September 16, 2019

Unique Issues With Cannabis-Related Patents & Their Enforcement

By Michael Annis, Liam Reilly

No Comments

While enforcement of cannabis patents through litigation is common, there are other alternatives to litigation. Here we discuss some of the unique cannabis-related issues that could arise before the Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademark Office (USPTO).

The growth and evolution of the cannabis industry in the U.S. are not slowing. However, the cannabis industry – with its tremendous upside – is still beset with uncertainty and limited legal guidance curbing its full potential. Intellectual property law, including patent protection, has emerged from the murky legal and regulatory landscape as a reliable business strategy with developing certainty.

A pioneering cannabis patent case in Colorado has progressed without any indication that cannabis patents are to be treated differently than other patents. Relatedly, PTAB recently upheld the validity of a cannabis-related patent as part of a post-grant proceeding. However, although the courts and the USPTO are not discriminating against cannabis patents because of their illicit subject matter, the true strength of these newly issued patents could be suspect.

The fledgling nature of cannabis businesses and the fact that cannabis is just now emerging from its statutorily imposed dormancy combine to highlight certain weaknesses of the USPTO and its mechanisms meant to strike spurious patents.

For several reasons, it is possible that applicants are propelling cannabis patent applications of questionable validity through prosecution beyond the point that similar applications could proceed. The USPTO’s experience with cannabis patents is limited. The universe of prior art available to patent examiners is also limited. There are only about three thousand active cannabis patents, which would only account for 0.6 percent of the total issued patents in 2015. The legal status of cannabis has also likely deterred the broadcasting of public use as prior art, and enabling publications or other public disclosures covering cannabis (e.g., published scientific studies) are limited as well. Taken together, patent examiners considering applications for cannabis patents are at a disadvantage compared to other applications that the USPTO considers in other fields.

Additionally, the post-grant proceedings before PTAB established to review issued patents of questionable validity are not designed to handle the historical context and unique issues of cannabis patents. The difference in the procedural rules and requirements of two common inter partes mechanisms for challenging issued patents, post-grant reviews (PGRs) and inter partes reviews (IPRs), creates a gap in coverage that is particularly salient to cannabis patents.

Although the cannabis patent case in Colorado is first of its kind, we can expect more to follow in its wake.Where a PGR petitioner is free to challenge an issued patent on effectively any ground, an IPR petitioner is limited to validity claims for lack of novelty or non-obviousness based solely on patents and printed publications. However, the PGR petitioner must be diligent, because it only has nine months from the issue date of the challenged patent to file a PGR petition. After those nine months, the challenger will have to rely on litigation or an IPR, with its limited basis for invalidity.

What this means for a cannabis patent is that unless a challenger – likely, a competitor in the cannabis space – can timely file a petition for a PGR, the basis for challenging the patent before PTAB are limited to those types of prior art that are especially rare in the cannabis space: patents and printed publications. What is more, meeting the nine-month requirement to file a PGR is no trivial task. The cost and time required to research and prepare a petition for PGR are particularly problematic for the cannabis industry with its lack of access to traditional forms of business financing.

As a result, it is reasonable to question the validity of contemporary cannabis patents. Further, because of PTAB’s enforcement gap, a patent challenger will likely have to resort to litigation to bring its invalidity arguments unrelated to claims of lack of novelty and non-obviousness based on patents and printed publications. Such broader invalidity arguments could include lack of patentable subject matter – which is an appealing challenge for patents that stem from naturally occurring plants or products, such as cannabis – or lack of novelty and non-obviousness based on other prior art.

Although the cannabis patent case in Colorado is first of its kind, we can expect more to follow in its wake. And, because of the weaknesses at the USPTO and PTAB, invalidity arguments in these early cases will likely be of increased strategic importance than in typical patent cases.

September 12, 2019

Soapbox

Stemming the Cannabis Black Market

By Matthew Zandi

3 Comments

On July 18, 2019, the Riverside County Sheriff’s Department in California served search warrants at 56 illegal cannabis cultivation sites. This operation was spearheaded by 390 law enforcement personnel, whose mission was to combat the ongoing problem of illegal cannabis cultivation sites throughout California.

The raids resulted in:

47,939 marijuana plants confiscated
2,132 pounds of processed cannabis
47 tons of cannabis plants disposed
2 Butane Honey Oil Labs located
71 firearms
49 arrests

The target of the operation was illegal cultivation sites. Individuals or licensed businesses with permits to grow cannabis legally were not affected.

Illegal cultivation is far from just a California problem. For example, if Oregon halted cannabis production today, the state would not experience a shortage as it has a six-year surplus.

The fear for investors and legal growers is that, if some growers turn to the black market to unload excess inventory, federal enforcement will come into play, which will set back the legal cannabis industry to the stone age. Oregon is currently making moves to limit licensure for legal production, but some active licenses may also need to be revoked, which would leave those licensees with vast investment losses. In other words, legalized cannabis’s massive economic market is not without financial problems of its own.

Don’t Make a Federal Case Out of It

Several states have legalized recreational cannabis with the intention of reimagining this vast underground market as an above-board business that bolsters the state’s economy via transparent dealings. To date, however, the federal government has refused to budge regarding cannabis’s status as an illegal Schedule 1 substance. This classification puts cannabis on a par with opioids. As such, those states that have legalized recreational cannabis are extremely motivated to keep these businesses on the up and up and not to pique federal interest.

Black Market Vulnerability

One of the tenets of legalizing cannabis is stemming the proliferation of black-market suppliers and minimizing the negative effects that the “war on drugs”has had in minority communities. These positive impetuses have yet to flourish. As a result of the illegal status of cannabis at the federal level, cannabis-legal states are forced to operate as islands.

Generally, taking legally purchased cannabis across state lines – from a legal to an illegal state – is illegal, and this is not only confusing but is also a recipe for complications. This leaves cannabis-legal states vulnerable to black market activity. These pockets of legal recreational cannabis that are popping up around the country loosen the constraints of the cannabis movement while the legality of this movement remains problematic. The results are an environment that’s extremely hospitable to black market activity.

Supply and Demand

The reality is that – due to supply and demand – cannabis costs about half as much in cannabis-legal states as it does in states in which it’s illegal. Black market growers in legal states destabilize the market. Those legit companies which remain above board, pay their taxes and jump through every legal hoop, cannot compete with black market interlopers who eschew such niceties.

The point made by detractors of legal cannabis isn’t lost on the rest of us – the black market is burgeoning.States that have legalized production have inadvertently made it easier for illegal producers to hide in plain sight, and the line between legal and illegal operations can become blurred. This creates new frustrations for law enforcement and naturally cuts into the legal cannabis trade. The situation has left some opponents to legalization demanding new crackdowns – others characterize such suggestions as amounting to a new war on drugs.

No Going Back

Detractors of legalized cannabis claim the somewhat chaotic effects related to the current patchwork approach to legalization are a result of opening the gates to legalization in the first place. However, putting the genie of legalized recreational cannabis back in the bottle simply isn’t feasible for operational, financial and political reasons. With the proliferation of attendant illegal operations, however, it is becoming more and more clear that leveling the playing field – via some form of federal legalization – is inevitable. The current state-by-state solution leaves too much wiggle room for the illegal transport of cannabis from those states with looser restrictions to those states with tighter protocols. If politics is choosing between the disastrous and the unpalatable, the billion-dollar cannabis conundrum is a great example. The question may no longer be should we legalize cannabis but, instead, how do we legalize cannabis.In other words, we need to find a path forward, and focusing only on the pitfalls that we’ve experienced so far isn’t going to get us where we need to be.

A Tale of Two Choices

The point made by detractors of legal cannabis isn’t lost on the rest of us – the black market is burgeoning. As such, we have an important decision to make. A blanket prohibition of cannabis may no longer be practicable, so we’re left to choose between legal and overt practices across the board or a hodgepodge of semilegal practices with covert ops in tow. Fostering illegal activity is rarely in our nation’s best interests, which leaves legalizing cannabis at the federal level as possibly the most practicable solution.

Protecting Public Health

As more states embrace the legalization of recreational cannabis, public health concerns remain an issue. Many of these illegal cultivators use chemicals that are banned in the United States and do not properly dispose of chemicals or waste products that destroy the environment, contaminate drinking water and have the potential to harm or even kill residents and domestic animals. Not only is this activity harmful, growers often steal electricity and water from surrounding residents.

Cobbling together a pastiche of laws, however, inevitably bolsters black market activity and does nothing to help protect public health. Even the staunchest proponents of legalizing cannabis don’t want minors involved in the equation. Additionally, few debate that unchecked usage is a healthy option. Quasi-legislation at the state level (and on a state-by-state basis), however, provides neither a check nor a balance.

Onward and Upward

The most likely next step for safeguarding public health, for stemming black-market activity, and for generating maximum revenues is toward thoughtful and comprehensive national legalization that comes sooner rather than later. In the meantime, law enforcement should protect the public, legal operations, investors, and the environment from the black market.

The opinions expressed are those of the author and do not necessarily reflect the views of Guidepost Solutions or its clients.

September 11, 2019

Agilent Partners with LSSU on Cannabis Chemistry & Research

By Aaron G. Biros

No Comments

Back in August, Lake Superior State University (LSSU) announced the formation of a strategic partnership with Agilent Technologies to “facilitate education and research in cannabis chemistry and analysis.” The university formed the LSSU Cannabis Center of Excellence (CoE), which is sponsored by Agilent. The facility, powered by top-of-the-line Agilent instrumentation, is designed for research and education in cannabis science, according to a press release.

The LSSU Cannabis CoE will help train undergraduate students in the field of cannabis science and analytical chemistry. “The focus of the new LSSU Cannabis CoE will be training undergraduate students as job-ready chemists, experienced in multi-million-dollar instrumentation and modern techniques,” reads the press release. “Students will be using Agilent’s preeminent scientific instruments in their coursework and in faculty-mentored undergraduate research.”

The facility has over $2 million dollars of Agilent instruments including their UHPLC-MS/MS, UHPLC-TOF, GC-MS/MS, LC-DAD, GC/MS, GC-FID/ECD, ICP-MS and MP-AES. Those instruments are housed in a 2600 square-foot facility in the Crawford Hall of Science. In February earlier this year, LSSU launched the very first program for undergraduate students focused completely on cannabis chemistry. With the new facility and all the technology that comes with it, they hope to develop a leading training center for chemists in the cannabis space.

Dr. Steve Johnson, Dean of the College of Science and the Environment at LSSU, says making this kind of instrumentation available to undergraduate studies is a game changer. “The LSSU Cannabis Center of Excellence, Sponsored by Agilent was created to provide a platform for our students to be at the forefront of the cannabis analytics industry,” says Dr. Johnson. “The instrumentation available is rarely paralleled at other undergraduate institutions. The focus of the cannabis program is to provide our graduates with the analytical skills necessary to move successfully into the cannabis industry.”

Storm Shriver is the Laboratory Director at Unitech Laboratories, a cannabis testing lab in Michigan, and sounds eager to work with students in the program. “I was very excited to learn about your degree offerings as there is a definite shortage of chemists who have experience with data analysis and operation of the analytical equipment required for the analysis of cannabis,” says Shriver. “I am running into this now as I begin hiring and scouting for qualified individuals. I am definitely interested in a summer internship program with my laboratory.”

LSSU hopes the new facility and program will help lead the way for more innovation in cannabis science and research. For more information, visit LSSU.edu.

September 10, 2019

Soapbox

Tips to Shrink your Shrinkage

By Carl Silverberg

No Comments

I had dinner last night with a friend who is a senior executive at one of the largest automobile companies in the world. When I explained the industry-accepted rate of 25-30% shrinkage in horticulture he said, “Are you kidding me? Can you imagine the story in the Wall Street Journal if I gave a press conference and said that we were quite content to throw away three out of every ten cars we manufactured?”

Yet, for all growers, operators and investors who complain about shrinkage, it’s an accepted part of the business. What if it wasn’t; what if you could shrink your shrinkage by 60% and get it down to 10% or less? How much more profitable would your business be and how much easier would your life be?

Let’s take the floriculture industry as our first example. You propagate chrysanthemums in February, they get repotted at the end of April and by the end of June, you might start to see some buds. In a very short time span your job changes from being a grower who manages 10,000 square feet of chrysanthemums to being an order taker. Over a period of eight weeks, you have to unload as many of those mums as possible. The sales team at Macy’s has more time to move their holiday merchandise than you do.

If you’re like most operations, your inventory tracking system consists of Excel spreadsheets and notebooks that tell you what happened in previous years so you can accurately predict what will happen this year. The notebooks give you a pretty accurate idea of where in the greenhouses your six cultivars are, how many you planted and which of the five stages they are in. You already have 30 different sets of data to manage before you add on how many you sell of each cultivar and what stage they were in.

The future of the industry is making data-driven decisions that free up a grower to focus on solving problems, not looking for problems.Then your first order comes in and out the window goes any firm control of where the mums are, what stage they’re in and how many of each cultivar you have left. A couple of hours after your first order, a second comes in and by the time you get back in touch, check your inventory, call back the buyer and she’s able to connect with you, those 2837 stage 3 orange mums are moving into stage 4. Only she doesn’t want stage 4 mums she only wants stage 3 so now you frantically call around to see who wants stage 4 orange mums very soon to be stage 5 mums.

And, the answer is often no one. What if you didn’t have your inventory count exact and now you have 242 yellow mums that you just found in a different location in your greenhouse and had you known they were there, you could have sold them along with 2463 other mums that you just located in various parts of your greenhouse.

It doesn’t have to be like that. We had a client in a similar situation, and they are on track to reduce their shrinkage to just a shade over 10%. The future of the industry is making data-driven decisions that free up a grower to focus on solving problems, not looking for problems.

And don’t think that shrinkage is an issue only in the purview of floriculture. It’s an even bigger problem for cannabis because of the high value of each crop. The numbers don’t sound as bad because unlike floriculture, you don’t have to throw out cannabis that’s not Grade A. You can always sell it for extract. But extract prices are significantly less per pound than flower in the bag.

Here’s how one grower explained it. “Because of the high value of the crop, and the only other crop I’ve worked with that high is truffles, you’re playing a much higher stakes game with shrinkage. Even if you try and salvage a bad crop by using all of the parts of the cannabis plant. Listen, the difference between Grade A and Grade C could be $1,000 for A while a pound of B/C is less than $400. If you produce a standard 180 to 200 pounds in your grow rooms, you’ve really screwed up. No operator is going to keep you if you just cost them $120,000.”