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California Manufacturing Regulations: What You Need To Know

By Aaron G. Biros
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In late November, California released their proposed emergency regulations for the cannabis industry, ahead of the full 2018 medical and adult use legalization for the state. We highlighted some of the key takeaways from the California Bureau of Cannabis Control’s regulations for the entire industry earlier. Now, we are going to take a look at the California Department of Public Health (CDPH) cannabis manufacturing regulations.

According to the summary published by the CDPH, business can have an A-type license (for products sold on the adult use market) and an M-type license (products sold on the medical market). The four license types in extraction are as follows:

  • Type 7: Extraction using volatile solvents (butane, hexane, pentane)
  • Type 6: Extraction using a non-volatile solvent or mechanical method
    (food-grade butter, oil, water, ethanol, or carbon dioxide)
  • Type N: Infusions (using pre-extracted oils to create edibles, beverages,
  • capsules, vape cartridges, tinctures or topicals)
  • Type P: Packaging and labeling only

As we discussed in out initial breakdown of the overall rules, California’s dual licensing system means applicants must get local approval before getting a state license to operate.

The rules dictate a close-loop system certified by a California-licensed engineer when using carbon dioxide or a volatile solvent in extraction. They require 99% purity for hydrocarbon solvents. Local fire code officials must certify all extraction facilities.

In the realm of edibles, much like the rule that Colorado recently implemented, infused products cannot be shaped like a human, animal, insect, or fruit. No more than 10mg of THC per serving and 100mg of THC per package is allowed in infused products, with the exception of tinctures, capsules or topicals that are limited to 1,000 mg of THC for the adult use market and 2,000 mg in the medical market. This is a rule very similar to what we have seen Washington, Oregon and Colorado implement.

On a somewhat interesting note, no cannabis infused products can contain nicotine, caffeine or alcohol. California already has brewers and winemakers using cannabis in beer and wine, so it will be interesting to see how this rule might change, if at all.

CA Universal Symbol (JPG)

The rules for packaging and labeling are indicative of a major push for product safety, disclosure and differentiating cannabis products from other foods. Packaging must be opaque, cannot resemble other foods packaged, not attractive to children, tamper-evident, re-sealable if it has multiple servings and child-resistant. The label has to include nutrition facts, a full ingredient list and the universal symbol, demonstrating that it contains cannabis in it. “Statute requires that labels not be attractive to individuals under age 21 and include mandated warning statements and the amount of THC content,” reads the summary. Also, manufacturers cannot call their product a candy.

Foods that require refrigeration and any potentially hazardous food, like meat and seafood, cannot be used in cannabis product manufacturing. They do allow juice and dried meat and perishable ingredients like milk and eggs as long as the final product is up to standards. This will seemingly allow for baked goods to be sold, as long as they are packaged prior to distribution.

Perhaps the most interesting of the proposed rules are requiring written standard operating procedures (SOPs) and following good manufacturing practices (GMPs). Per the new rules, the state will require manufacturers to have written SOPs for waste disposal, inventory and quality control, transportation and security.

Donavan Bennett, co-founder and CEO of the Cannabis Quality Group

According to Donavan Bennett, co-founder and chief executive officer of the Cannabis Quality Group, California is taking a page from the manufacturing and life science industry by requiring SOPs. “The purpose of an SOP is straightforward: to ensure that essential job tasks are performed correctly, consistently, and in conformance with internally approved procedures,” says Bennett. “Without having robust SOPs, how can department managers ensure their employees are trained effectively? Or, how will these department managers know their harvest is consistently being grown? No matter the employee or location.” California requiring written SOPs can potentially help a large number of cannabis businesses improve their operations. “SOPs set the tempo and standard for your organization,” says Bennett. “Without effective training and continuous improvement of SOPs, operators are losing efficiency and their likelihood of having a recall is greater.”

Bennett also says GMPs, now required by the state, can help companies keep track of their sanitation and cleanliness overall. “GMPs address a wide range of production activities, including raw material, sanitation and cleanliness of the premises, and facility design,” says Bennett. “Auditing internal and supplier GMPs should be conducted to ensure any deficiencies are identified and addressed. The company is responsible for the whole process and products, even for the used and unused products which are produced by others.” Bennett recommends auditing your suppliers at least twice annually, checking their GMPs and quality of raw materials, such as cannabis flower or trim prior to extraction.

“These regulations are only the beginning,” says Bennett. “As the consumer becomes more educated on quality cannabis and as more states come online who derives a significant amount of their revenue from the manufacturing and/or life science industries (e.g. New Jersey), regulations like these will become the norm.” Bennett’s Cannabis Quality Group is a provider of cloud quality management software for the cannabis industry.

“Think about it this way: Anything you eat today or any medicine you should take today, is following set and stringent SOPs and GMPs to ensure you are safe and consuming the highest quality product. Why should the cannabis industry be any different?”

Did ABCann Lose The German Cannabis Bid?

By Marguerite Arnold
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In rather shocking news out of Germany on the cannabis front, it appears that Canadian LP ABcann has not been selected as one of the finalists in the country’s first tender bid to cultivate cannabis domestically.

As reported in the German press, the company has not been invited to submit an offer in the final award procedures. The reason per a company spokesman as quoted in the German media? The company proved it met the required qualification thresholds – namely it could deliver the required amount of product as required by the German government. However the amount it could produce was less than other firms being considered.

That is a strange statement, especially because the ten licenses on offer only called for a total of 2,000 kgs of production total by 2019 and 6600 kgs by 2022.

Who Is ABCann?

ABcann has been in business since 2014 in Canada, when it received one of the first cultivation licenses issued by the Canadian government. It has also been aggressively positioning itself in the German and European market this year – and in multiple ways. It got itself listed on both American and German stock exchanges by summer. The company established a subsidiary headquarters in Schönefeld as of August 2017. As late as October, the company also was appearing at industry conferences, like the IACM medical conference in Cologne, as an expected finalist in the first bid.

An ABCann facility in Canada

However, the company’s plans to build a $40 million, 10,000 square meter plant somewhere in Lusatia are now also reportedly on hold. The exact location of the plant is unknown, per German government requirements that grow facilities remain secret. That said, with a year and a half to complete construction, if given the green light even by early next year, it may be that this was the reason the company has apparently not made the cut. Or perhaps the German government did not believe the company was adequately funded. A September exercise of warrants netted the company an additional $45 million in operating cash. But with expansion plans in not only Canada and Europe, but Australia too, did the company pass the German test for liquidity?

Management changes are also afoot. As of October 1, Barry Fishman, a former Eli Lilly executive took over as CEO of ABCann Global. Ken Clement, founder of the company, announced in mid-October that he was stepping down from his position as Executive Chair of the Board to be replaced by Paul Lucas a former President and CEO of GlaxoSmithKline Canada. John Hoff, the Geschäftsführer (or CEO) of ABcann’s German subsidiary, has also recently left the company. When asked by CannabisIndustryJournal about his reasons for doing so at the Cannabis Normal conference in Berlin at the beginning of November, Hoff cited “management and creative differences” with ABcann Canada as the impetus for his recent departure.

However with the news of ABcann’s apparent loss of a front-runner position in the pending bid, such news appears to herald a bit more of a shakeup at the company, if not a refocussing of overall global strategy.

A source within the company who wished to remain anonymous also said this when contacted directly by CannabisIndustryJournal. “Our top priority currently is to acquire an import license. We also fully intend to pursue all of our plans in the German market, but we have no firm dates on the construction front.”

The State of Medical Cannabis Reform Auf Deutsch

The German medical cannabis question has certainly jerked forward over the past several years through several rough patches. This year it has gotten even stranger. And nobody is quite sure where it will end up.

The news about ABcann is also the latest episode in a very strange story that has continued to develop mostly out of sight of the public.

That bid process, which was expected to announce the winners by late summer, has now dragged on through the fall.Germany began moving forward quietly on the cannabis issue in the first decade of the century. Patients could only access the drug in basically trial mode. Most patients who qualified with a doctor’s prescription and a special permit to take the drug, could also access only Sativex (which is very expensive) or the synthetic form of the drug, dronabinol, manufactured domestically in a facility near Frankfurt. All bud cannabis was imported from Holland by Bedrocan. Strictly controlled not by German, but rather Dutch law on cannabis imports.

In 2014, the first German patients successfully sued the government to grow their own plants if their insurance companies refused coverage of the drug and they proved they could not afford alternatives.

This year, in January, the German government voted unanimously to change the law to mandate public health insurance. The law went into effect in March. Mainly driven by a desire to halt home-grow, the rules changed again. Post March 2017, patient grow rights have now been revoked. Now patients are theoretically allowed to get cannabis covered under public health insurance. In reality, the process has been difficult.

In April, the German government created a new “Cannabis Agency” under the auspices of BfArM. And BfArM in turn issued a tender bid for the country’s first domestic licences in April.

That bid process, which was expected to announce the winners by late summer, has now dragged on through the fall.

When Will The Winners Be Announced?

That too is unclear. It is very likely that the final announcement will not be made by the government until the beginning of the year – after the new government is formed. The so-called “Jamaica Coalition” – of the mainstream CDU, the Greens and the liberals (FDP) is under major pressure to address the issue of access. So far Chancellor Angela Merkel has signalled her resistance for additional changes to the new cannabis law. That said, the current situation in Germany, which is untenable for patients and doctors, as well as companies trying to enter the market and investing heavily, is unlikely to hold for even the next several years.

Problems with finding doctors and medical reimbursement under insurance have kept this patient population from growing the way it would otherwise.In late October, the news broke that two legal complaints had been unsuccessfully filed against the bid itself. Both parties’ complaints were dismissed. Yet there also appears to have been a third complaint that has actually devolved in to a real Klage – or lawsuit. Lexamed GmbH’s claim directly addresses issues expressed by many German-only firms this year. Namely that they were unfairly left out of the bid process because of a supposed lack of experience. As such it is likely to be closely watched by other existing German hopefuls.

This lawsuit has now formally delayed the announcements on the bid decision until at least after December 20th of this year, when the oral arguments will be heard in the case. A decision about the bid will go forward when this has been decided, by the beginning of 2018.

In the meantime? Cannabis imports are starting to enter the country. In late summer last year, Spektrum Cannabis, formerly MedCann GmbH, located just south of Frankfurt, received the first import licenses from the German government to bring medical cannabis into Germany from Canada. Both Aurora and Tilray were granted import licenses this fall.

There are 16 different kinds of cannabis on the market right now. And about 170 kilos of cannabis were imported into the country in the last year. There are also currently about 1,000 patients although this number is artificially low. Problems with finding doctors and medical reimbursement under insurance have kept this patient population from growing the way it would otherwise. There are easily a million patients in Germany right now who would qualify for cannabis if the system worked as it was originally intended in the legislation passed in January.

That said, despite the recent news that ABcann is “out” – at least for this round– apparently the pan-European bid process is still very much alive, despite many recent rumours that it was dead in the water. And plans also seem to be afoot for a separate and additional cultivation licensing round potentially as soon as next year. Details however are unclear and nobody either in the industry or the government is willing to be quoted or give any further information.

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Sustainability & Quality Go Hand-In-Hand In The Cannabis Industry

By Dr. Zacariah Hildenbrand
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I recently attended the CannaGrow Expo held in Denver, Colorado. It was a fantastic event, per usual, and I was pleasantly surprised to see a number of presentations by industry experts where the central themes were sustainability and environmental stewardship. I was particularly struck by Adam Maher’s presentation, where he discussed the merits of micro grid technologies and the ease in which they can be coupled with renewable energy modalities, such as solar. His sentiments really resonated with me, particularly with respect to the long-term implications of cannabis cultivation sweeping across North America.

Considering that cannabis represents the new frontier of modern medicine and its societal acceptance is rapidly spreading, there is a growing impetus for cannabis professionals to implement technologies that will enhance the sustainability of their operations. These pertain to, but are not limited to, power generation and lighting, both of which are integral components to any indoor cannabis cultivation facility. Not only can the utilization of energy efficient technologies (i.e., solar panels and LED lights) help our planet that is struggling mightily to neutralize the influences of anthropogenic climate change, but it can also add value to the bottom line. That’s right: environmental stewardship, product quality and financial success are not mutually exclusive in the cannabis industry. For example, the utilization of solar panels and/or a micro grid can have a relatively rapid payback (<6 years), while the hardware itself adds inherent value to any cannabis property/operation. This is particularly relevant in an emerging market where acquisitions are common and the management of asset value is a harbinger of success. Secondarily, the use of LED lighting technologies to produce ultra-premium cannabis is another piece of low-hanging fruit that can be picked to add value. For example, 1st and 2nd place in Arizona’s 2017 ERRL Cup were awarded to flower that was grown under LED lights designed by the Tall Trees LED Company, where the total cannabinoid levels exceeded 32% and a wide variety of terpenes were detected. These results, coupled with the fact that LED lights can provide full spectrum light that requires less energy and produces less heat than HPS lights, make the adoption of LED lights a simple choice for the environmentally conscious and financially savvy operator.

As we continue to move towards more states becoming cannabis powerhouses, and a potential federal rescheduling, the industry must continue pushing the operational equilibrium towards more resourceful technologies. Of course there is always going to be a perceived activation energy or threshold that must be transcended before the adoption of new technologies can be successfully accomplished with confidence. This is completely normal and is usually associated with the initial capital that is required to acquire such technologies, and/or fears that such an investment won’t bear fruit. However, there is currently enough data to indicate that technologies like solar panels and LED lights are a smart financial choice for any cultivation facility where there is sunlight and electrical outlets.

In summary, I would strongly encourage any operator to evaluate the sustainability and environmental stewardship of their business, especially if they anticipate spreading the holistic gospel of cannabis medicine for many years to come. You are already doing a tremendous service for those who depend on cannabis medicine and now is the time to continue your noble pursuit while taking care of Mother Earth and paying it forward to our subsequent generations.

Colorado To Begin Requiring Potency Testing For Medical Infused Products

By Aaron G. Biros
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After a delay due to their proficiency testing program roll out, the Colorado Marijuana Enforcement Division (MED) will now require all medical infused products and concentrates be tested for potency and homogeneity, starting November 1st, 2017.

After November 1st, all production batches of concentrates from medical product manufacturers will need to have a potency test before being sold, transferred or processed. The same goes for medical infused products, such as edibles and topicals. The homogeneity test refers to making sure THC or other active ingredients are distributed evenly throughout the product.

According to Alex Valvassori, author of a regulatory compliance-focused blog post on Complia’s website, these new testing requirements could lead to a surge in pricing, passed on to patients. He also recommends dispensaries take a close look at labels coming in from suppliers. They need to make sure potency data is listed clearly on the label to stay compliant.

Production batches created before November 1st are not required to meet the new testing regulations, but any and all batches after that date will be required to perform those tests.

How To Select The Best Monitoring System For Your Cannabis Greenhouses

By Rob Fusco
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Maintaining an environment that supports cultivation and keeps plants healthy is not an easy task. In cannabis growing, there are a variety of factors that greenhouse managers and personnel must monitor to ensure that their plants are in a healthy environment that fosters growth and development. Temperature, humidity, lighting and CO2 levels are a few of the conditions that need to be tailored to each cannabis greenhouse operation. However, it can be difficult to constantly monitor the status of your equipment and the greenhouse environment, especially after hours or during the off-season.

A remote monitoring system that’s properly selected and installed can help greenhouse managers keep their cannabis plants healthy, multiply their yields and increase return on investment. This type of system also helps operators identify patterns and trends in environmental conditions and get insight into larger issues that can prevent problems before they arise.

Cloud-based monitoring system base unit in weatherproof enclosure

Here are some tips on key conditions to monitor and what you need to consider when selecting a monitoring system for your cannabis greenhouse operation:

Temperature

Temperature plays a crucial role in any cannabis grow operation. The climate in your greenhouse must be warm enough to nurture photosynthesis and the growth of cannabis plants. Setting the incorrect temperature will significantly impact the potential yield of the plant and the rate at which it develops. A temperature too low will slow the growth of the cannabis, but too hot can lead to heat stress for your plants. The ideal temperature for a standard greenhouse is between 70 and 80 degrees Fahrenheit. However, depending on the stage of plant and desired growth densities, the temperature of the greenhouse needs to be adjusted accordingly.

Humidity Levels

Humidity directly affects plant photosynthesis and transpiration, so controlling humidity is vital in greenhouse growing. The ideal relative humidity (RH) for cannabis growth is around 60%. A low humidity level can cause water to evaporate too quickly for photosynthesis, while a humidity level that is too high can cause poor growth and possible mold and fungal disease. Monitoring the moisture content in the air of your greenhouse will help the plants during the transpiration process, increasing absorption of nutrients and overall health of the cannabis. 

Lighting

Your cannabis may be getting an abundance of natural light during the summer months, but maintaining adequate sunlight during the winter months can be a challenge. As a solution to this, many greenhouse managers equip their facilities with additional lights to supplement natural light during off-seasons or off-hours. To achieve the best possible yield, a cannabis plant in the budding stage should receive twelve hours of light each day, while other stages could require additional lighting. For example, the growth stage could require your cannabis to be exposed to sunlight for up to eighteen hours a day.

CO2 Levels

Like any other plant, cannabis requires CO2 to breathe. Greenhouse managers must set and monitor the CO2 levels in their facility to make sure that there is an adequate amount for the plants to develop, grow and be healthy. The amount of carbon dioxide required for your cannabis depends of the size of the facility and the amount of light the plants are receiving. However, a standard grow area for cannabis can maintain a CO2 range from 1000 to 1500 parts per million (PPM). A level below that threshold can result in slower growth of the plants, while a level above would lead to unused and wasted CO2.

Soil moisture sensor

Irrigation and Soil Moisture

One way to ensure a good yield from your cannabis is to water it regularly and monitor your soil moisture. Overwatering your plants can have the same effect, if not worse, than letting the soil become too dry. Plants’ roots need oxygen to survive, unlike leaves that breathe CO2, and when the soil is waterlogged the roots can’t provide their function. The lack of oxygen interferes with the roots’ nutrient uptake and photosynthesis causing the cannabis plant to wilt. The exact moisture content of the soil depends on the size of your greenhouse, temperature and humidity. Whether you hand water or are using a drip irrigation system, being aware of your soil moisture is vital to the long-term health of your cannabis.

Air Circulation

Your greenhouse environment should mimic the ideal conditions in which cannabis plants flourish. With an indoor facility, you have the ability to control air circulation by venting hot air out and blowing fresh air in. Creating a circulation of air inside your greenhouse will increase your cannabis plant’s growth speed and yield. Additionally, an exhaust system helps control the temperature and humidity, while also preventing the invasion of mold and pests that thrive in hot, stagnant air.

Greenhouse Security

When growing something of value, like cannabis, there will always be a threat of intruders. Whether your greenhouse is in a populated area or around hungry wildlife, any intruder could be detrimental to your overall yields and profit. Remote monitoring systems can give you peace of mind and instantly alert you when there is an unwanted presence in your greenhouse.

Knowing all the possible threats to your cannabis greenhouse helps you evaluate your specific needs, and ultimately identify the proper remote monitoring system.

Selecting the Right Monitoring System

Other factors to consider when choosing a monitoring system right for your operation include:

  • Base unit and sensors
  • Wireless or hardwired sensors
  • Communications to your site (Phone, cellular, Wi-Fi, etc.)
  • Alarm notification
  • Programming and status checks
  • Data logging
  • Return on investment

Base Units and Sensors

Each condition in your greenhouse that you want to monitor requires its own input on the base unit of the monitoring system. You must match your needs with the number of inputs available. A good fit for a smaller cannabis greenhouse may be a lower-cost, non-expandable monitoring system. However, larger facilities have many monitoring points and more people to alert when there’s a problem. If your cannabis operation is poised for growth, purchasing an expandable system could add value to the initial purchase because you wouldn’t have to replace your entire system in the future.

Your monitoring system should also have an internal rechargeable battery backup to ensure continuous monitoring and alerts in the event of a power outage. It is also recommended to have each base unit in a sheltered enclosure to protect it from moisture, dirt and other hazards.

Placement of sensors is also crucial. For example, temperature sensors in your greenhouse should be placed throughout the facility. They should be next to your thermostat and in the center of your greenhouse, preferably away from direct sunlight.

Wireless or Hardwired Sensors

Remote monitoring systems offer the option to have sensors hardwired directly to the base unit or sensors wirelessly connected. A hardwired monitoring system connects the sensors to the base device with wires. Generally, trenching long distances for wires is time consuming and costly. So alternatively, a wireless system uses built-in radio transmitters to communicate with the base unit. Some monitoring systems can accommodate a combination of hardwired and wireless sensors.

Communications to Your Site

Monitoring devices that use cellular communications must be registered on a wireless network (like Verizon or AT&T) before you can send or receive messages. Because cellular devices perform all communications over a wireless network, it is important that there be sufficient signal strength at the greenhouse. It is a good idea to check the signal quality in the area before purchasing a cellular product. If the cellular network has less than desirable coverage, it is possible to install an external antenna to help increase cellular signal.

Alarm Notifications

When monitoring systems identify a change in status, they immediately send alerts to people on the contact list. If you don’t want all of your personnel to receive notifications at the same time, certain devices can be programmed to send alerts in a tiered fashion. It is important to consider the reach of the communications, so that you’ll be notified regardless of your locations. Multiple communications methods like phone, email and text provide extra assurance that you’ll get the alert. Also, note of the number of people the system can reach and if the system automatically cycles through the contact list until someone responds. Make sure the system allows for flexible scheduling so that it doesn’t send alarms to off-duty personnel.

Programming and Status Check

If you’re responsible for maintaining a commercial greenhouse facility, you want a system that will provide real-time status of all monitored conditions on demand. There are a few different ways to access your sensor readings. Options include calling to check status, viewing a web page, either on a local network or on the cloud, or accessing the information via an app on your mobile device. With a cloud-based system, the devices supervise themselves. This means if the internet or cellular connection goes down, the device will send an alarm to alert the appropriate personnel.

If you don’t select a cloud-based system, you will be limited to logging in through a local area network, which will allow you to make programming changes, access status conditions and review data logs. If internet connectivity is not available at your location, you will want to choose a cellular or phone system rather than Ethernet-based option.

Data Logging

Sample greenhouse monitoring data log

Data history is valuable in identifying patterns and trends in your cannabis greenhouse conditions. Manually monitoring and recording environmental parameters takes a significant amount of personnel time and detracts from other important workplace demands. However, many monitoring systems automatically save information, recording tens of thousands of data points, dates and times. Cloud-based logging provides an unlimited number of records for users to view, graph, print and export data trends.

Analyzing data samples may lend insight to larger issues and prevent problems before they arise. For example, if the data log shows power fluctuations occurring at a regular time, it could be indicative of a more serious problem. Or, if the data shows signs of a ventilation fan or supplementary lighting beginning to malfunction, they can be repaired or replaced before total failure occurs.

Return On Investment

When deciding how much you should pay for a remote monitoring system, tally up the entire cost, fully installed with additional peripherals and sensors and any labor fees for installation. Then consider the value of your cannabis plant inventory and greenhouse equipment. Finally, factor in the cost of downtime, should an environmental event shut down your operation for a period of time.

Final Thoughts

Choosing the right greenhouse monitoring system and sensors could mean the difference between life and death for your cannabis plants. Understanding the conditions you need to watch and monitoring systems’ capabilities are they best way to protect your investment.

 

Canadian Company Recalls Contaminated Cannabis

By Aaron G. Biros
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Broken Coast Cannabis Ltd., a cannabis business located on Vancouver Island, issued a voluntary recall of three cannabis lots due to the detection of pesticides. According to the safety alert published on Health Canada’s website, the voluntary Type III recall follows an inspection of the facility back in March of this year.

A Type III recall means those products are not likely to cause negative health effects. Sampling of those three cannabis lots found a cannabis oil product in July to contain low levels of Myclobutanil and Spinosad.

Upon further testing, a cannabis leaf sample was found to contain 0.017 parts-per-million of Myclobutanil. A third party laboratory confirmed the presence of that fungicide, leading them to recall three lots of dried cannabis sold between July and December of 2016, according to that safety alert.

Spinosad, an insecticide, and Myclobutanil, a fungicide, are not authorized for use with cannabis plants per the Pest Control Products Act, however they are approved for use in food production. The health risks of ingesting either of those two chemicals are well documented. “Health Canada has not received adverse reaction reports related to Broken Coast Cannabis Ltd.’s products sold affected by the recall,” reads the safety alert. “Health Canada recommends that any individual affected by the recall immediately stop using the recalled product and to contact Broken Coast Cannabis Ltd., at the following number 1-888-486-7579.”

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Human Error? No Problem

By Dr. Ginette M. Collazo
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If you are in the business of growing cannabis, you should be aware of the common reasons for production losses, how to address root causes and how to prevent future occurrences in a sustainable way. Human error is the number one root cause identified in investigations for defects in the cultivation business. Sadly, little is known about the nature of these errors, mainly because our quest for the truth ends where it should begin, once we know it was a human error or is “someone’s fault.”

Yes, human error usually explains the reason for the occurrence, but the reason for that error remains unexplained and consequently the corrective and preventive actions fail to address the underlying conditions for that failure. This, in turn, translates into ineffective action plans that result in creating non-value added activities, wasting resources and money as well as product.

Human error can occur when workers are in direct contact with the plant

So after investigating thousands of human error events and establishing systems to improve human reliability in manufacturing facilities, it became even clearer to me, the need to have good, human-engineered standard operating procedures (SOPs).

In the cannabis growing process, there are different types of mistakes that, when analyzed, all can be addressed in the same manner. For example, some common errors that we see are either overwatering or nutrient burn, which can occur when the plant is overfed. The same is true in the opposite scenario; underfeeding or under watering lead to problems as well. If your process is not automated, the reason for these failures was most likely human error. Now, why did the person make that mistake? Was there a procedure in place? Was the employee trained? Is there a specific process with steps, sub-steps, quantities and measures? Were tools available to be able to do the task correctly? There is so much that can be done about these questions if we had clear, well-written and simple, but specific instructions. The benefits greatly outweigh the effort required.

Also, besides providing step-by-step instructions to avoid commission errors (to perform incorrectly as opposed to omit some step), there are other types of errors that can be avoided with SOPs.

Decision making like detecting nutrient deficiencies can lead to human error.

Decision-making is another reason why we sometimes get different results than the ones expected. If during your process there are critical, knowledge-based decisions, workers need to be able to get all the information to detect as well as correct situations. Some decisions are, for example, when (detection) and how (steps) should I remove bud rot? Is there a critical step in the process (caution) to avoid other plants from becoming affected? Any information on the what, how, when, where and why reduces the likelihood of a decision error, later described as obvious.

When we face manufacturing challenges like nutrient deficiency in a particular stage, mold, fungus, gnats or even pollination of females, we want to do whatever we can to prevent it from happening again. So consider that from avoiding to detecting errors, procedures are a critical factor when improving human performance.

Here are some guidelines when writing procedures to prevent human error.

  1. Use them. Enforce the use of procedures at all times. As humans, we overestimate our abilities and tend to see procedures as an affront to our skills.
  2. Make sure it is a helpful procedure and users are involved in the process. People that participate in writing rules are more likely to follow them.
  3. Make sure they are available for their use.
  4. All critical activities should have a procedure.
  5. The procedure needs to be clear, have a good format, clear graphics, appropriate level of detail and specific presentation of limits.
  6. Make sure that facts, sequence and other requirements are correct and all possible conditions are considered e.g. “what if analysis”.

Human error won’t be eradicated unless we are able to really identify what is causing humans to err. If eliminating or “fixing” the actual individual eliminates or potentially reduces the probabilities of making that mistake again, then addressing the employee would be effective. But if there is a chance that the next in line will be able to make the same mistakes, consider evaluating human factors and not the human. Take a closer look and your process, system and ultimately your procedures.

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Biros' Blog

Sustainability of Cultivation in 2016, Part II

By Aaron G. Biros
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In the second part of this series, I speak with Alex Cooley, vice president of Solstice, to find out what particular solutions growers can use to increase efficiency. Last month, I introduced the challenge of growing cannabis more sustainably. To recap, I raised the issue of sustainability as an economic, social and environmental problem and referenced recent pesticide issues in Colorado and carbon footprint estimates of growing cannabis.

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The growers at Solstice put their plants under a trellis net to increase yield.

Alex Cooley is the vice president of Solstice, a cultivation and processing business based in Washington. Solstice is at the forefront of the industry for innovating in energy, water and raw materials efficiency. I sat down with Cooley to discuss exactly what you can do to grow cannabis sustainably.

“Switching to outdoors or greenhouse will always be more sustainable than indoor, but depending on the type of facility, energy efficiency and specifically lighting should be at top of mind,” says Cooley. “Just looking at your bottom line, it is cheaper to use energy efficient lighting sources such as plasma or LED lighting, which will reduce your need for air conditioning and your overall energy consumption.”

Looking into sustainable technologies is one of the quicker ways to improve your overall efficiency. “We are big believers in VRF [variable refrigerant flow] HVAC systems because it is one of the most energy efficient ways to cool a large space in the world,” adds Cooley. “Use a smart water filtration system that gets away from wasting water by catching condensate off AC and dehumidifiers, filtering and then reusing that water.”

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Indoor cultivator facilities use high powered lights that give off heat, requiring an efficient air cooling system like VRF HVAC.

Utilizing your waste streams is another relatively simple and cost effective practice to grow cannabis sustainably. “Our soil and biomass goes through a composting company, we recapture any of our waste fertilizer and runoff for reuse,” says Cooley. “We try to use post-consumer or fully recyclable packaging to reduce what would go into the waste streams.”

So some of the low hanging fruit to improve your bottom line and overall sustainability, according to Alex Cooley, include things like reusing materials, composting, increasing energy efficiency and saving water. These are some of the easily implementable standard operating procedures that directly address inefficiency in your operation.

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The tops of plants are beginning to flower in this Solstice indoor facility.

In the next part of this series, I will discuss Terra Tech’s approach to sustainable cultivation, which utilizes the “Dutch hydroponic greenhouse model” on a large scale growing produce such as thyme and basil, but are now taking their technologies and expertise to the cannabis industry. I will also discuss the benefits of using a third party certification, Clean Green Certified, to not only help grow cannabis more ecofriendly, but also market your final product as such. Stay tuned for more in Sustainability of Cultivation in 2016, Part III.

Pesticide Position Paper: Prepared by Comprehensive Cannabis Consulting (3C)

By Adam Koh, Nic Easley
4 Comments

Those that follow the legal cannabis industry are undoubtedly aware of the struggles of Colorado to regulate pesticide use on cannabis. At the time of this writing, there have been 19 recalls of products contaminated by pesticides in as many weeks. Authorities could not in all cases identify exactly how many units of products may have been tainted, but based on the numbers available, roughly 200,000 individual cannabis products, if not more, have been pulled from dispensary shelves. Along with these recalls have come a large amount of coverage and commentary from various news outlets, industry stakeholders, and even those companies who have had products pulled from shelves.

As this is a controversial and contentious subject, it can be difficult to parse and evaluate the various points of view being offered. In what follows, we will outline the issues at hand objectively: first providing a brief overview of federal and state pesticide regulations and how they pertain to cannabis; addressing claims of whether pesticide usage is “safe” or not; and, finally, offering our opinion of how the cannabis industry should address the pesticide conundrum considering the current regulatory environment and the state of our knowledge.

Before diving in, we are also aware that there is controversy around cannabis testing methodologies, and that the reliability of cannabis testing labs in general has been called into question by a number of the companies that have faced recalls. While we cannot comment on the operations of particular labs, we do support the application of consistent standards, proficiency evaluations, and stringent regulatory oversight to testing labs themselves, so that their results can be assured of being beyond reproach.

Still, 3C’s stance is that quality cannot be tested into a product. To have growers continue to produce contaminated cannabis only to see it recalled repeatedly is unsustainable for the industry; indeed, it threatens its very existence, as we discuss below. That is why we focus in this paper on the cultivation of the plant, as correcting problems on the production side is the only way to ultimately resolve the dilemma in which the industry finds itself.

Pesticide Regulation in the US Relative to Cannabis Cultivation

Cannabis’ pesticide problems stem in large part from the fact the pesticide regulation takes place at the federal level, under the auspices of the EPA. All pesticides undergo years of research and development before they can be sold to farmers and employed on crops. That research addresses questions such as where and how a pesticide can be employed, on what crops, in what concentrations, with what frequency, and how long before harvest can a pesticide be applied. Questions of worker safety are also addressed, such as those concerning what Personal Protective Equipment (PPE) might be required and how long workers must avoid treated areas (Re­Entry Intervals), among other concerns.

The fruits of such studies are then distilled to the contents of a pesticide’s label, which must be registered with and approved by the EPA before a pesticide can be distributed for sale. Federal and state laws require that pesticides be applied according to label directions, making the label a legal document of sorts. “The label is the law,” is a phrase common among agricultural professionals with which the legal cannabis industry is becoming acquainted.

The sticking point in regard to cannabis is that, due to its federal illegality, no research has been performed on the use of pesticides on cannabis. Due to the lack of research, no pesticides registered currently with the EPA are labeled for use on cannabis. Since all pesticides must be applied according to label specifications, this essentially prohibits pesticide use in cannabis production. However, some labels are written in such a broad manner that the use of those pesticides could not be construed as a breach of the legally­ binding use directions. Additionally, certain pesticides are of such low­toxicity that the EPA has deemed that their registration is not required; these are known as minimum­ risk products under section 25(b) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). At this time, the Colorado Department of Agriculture (CDA), in an attempt to offer guidance to cannabis growers, is maintaining a list of such products that, either due to broad label language or 25(b) status, may be used on cannabis without that use being a violation of the label.

Are Pesticides Safe for Use on Cannabis?

Since the first plants to be quarantined after discoveries of improper, off­-label pesticide use to the most recent recalls, some of the Colorado cannabis companies caught up in those enforcement actions have made public statements claiming that their products are safe. These statements are dangerously misleading, as they do not take into account the issues laid out above, nor the facts that follow.

Frequently, attempts to justify such claims point out that pesticides are employed on our food and therefore must be okay to apply to cannabis as well. This is a classic case of comparing apples to oranges; or, in this case, comparing apples and oranges to cannabis. Such data cannot be bridged for the simple reason that apples and oranges (and most other agricultural food crops) are not smoked. Smoking remains the primary method of cannabis ingestion, but cannabis products are also vaporized (concentrates), consumed (edibles), applied to the skin (topical creams and patches), and taken sublingually (tinctures, sublingual strips).

As noted, the studies that pesticides must undergo prior to being approved by the EPA involve measuring acceptable residues based on the method of consumption of the final product. Since most food is consumed and digested, few pesticides on the market have undergone pyrolysis studies, which examine how the chemical structures of pesticides degrade when burned. This means that while the fungicide myclobutanil, the active ingredient in Eagle 20EW, may be approved for use on grapes, that approval is meaningless in regard to cannabis, as grapes are not smoked and the relative safety of myclobutanil residues was not tested in regard to such a consumption method.

While studies may eventually reveal that certain pesticides may be used on cannabis without ill effects to the end users, such research has not been performed and no one can say with certainty what the effects of consuming cannabis containing pesticide residues might be. Even the CDA qualifies the list of products that may be used without violating labeling guidelines with the following statement, “These products have not been tested to determine their health effects if used on marijuana that will be consumed and thus the health risks to consumers is unknown.”

Again, no one can currently say what pesticides, if any, can be safely employed on cannabis; anyone claiming definitively that their products are safe despite off­-label pesticide use is making a statement that at this time lacks any scientific basis whatsoever.

Another claim made numerous times by companies defending their off­-label pesticide use is that no one has yet fallen ill from pesticide use on cannabis. While this is true, we must remember that we are in uncharted territory, and no large­scale public health studies have been done to determine what, if any, effects result from consuming cannabis to which pesticides were applied. We hope that no ill effects will surface, but the fact of the matter is that chronic health issues may take years to show themselves and a public health crisis may yet emerge.

Recommendations for the Cannabis Industry

We are advocates for cannabis legalization and want to see this industry grow and develop into one that is beneficial for all involved. We believe that cannabis can continue to be a force for positive change in numerous areas of society, from medicine to criminal justice to agriculture, and beyond. But, in order for it to do so, we must navigate issues such as those around pesticide use in an intelligent and responsible manner.

Our primary recommendation should be preceded by the statement that the use of chemical pesticides of the type triggering Colorado’s recalls is not needed in cannabis production. We make this statement based on years of experience working in, managing, and advising cultivation operations of all types, methodologies, and scales on how to grow successfully without illegal pesticides. Cannabis has survived and flourished throughout human history without pesticides, and will continue to do so if we cultivate it correctly.

As such, we recommend that growers n​ot​ employ any pesticides in a manner that violates label directions, and only use 25(b) products that have undergone pyrolysis testing to ensure that they are not releasing harmful compounds when burned. Furthermore, applications should only be made during the vegetative stage, prior to the emergence of flowers. Overall, if there is any doubt as to whether a product or material is safe, it should not be used until legitimate, peer­-reviewed research has been performed by a reputable institution.

Successful pest control can be achieved via intelligent facility design, robust environmental controls, workflow protocols, and strict cleanliness standards, in addition to preventative applications of appropriate minimum­ risk pesticides. There is no magic bullet that will solve all pest problems, which is why experienced agricultural professionals rely on Integrated Pest Management (IPM), defined as “an ecosystem­-based strategy that focuses on long­term prevention of pests or their damage through a combination of techniques such as biological control, habitat manipulation, modification of cultural practices, and use of resistant varieties.” Overall, the adoption of Good Agricultural Practices (GAP) is much needed in the industry, and cannabis growers should look to agricultural operations that promote the four pillars of GAP standards (economic viability, environmental sustainability, social acceptability, and safety and quality of the final product) for guidance in formulating best practices in this new field.

This recommendation is not simply a matter of principle, but one that will preserve your business. In addition to costly and brand­-damaging recalls, we have already seen the first product liability lawsuits filed last year against LivWell by cannabis consumers over off­label pesticide use. Another issue is that of worker safety. Most cannabis cultivation takes place indoors, where pesticide residues can linger in garden areas and on equipment, creating toxic work environments. Unfortunately, based on the widespread nature of pesticide use in the legal cannabis industry, we feel confident in stating that thousands of workers employed in legal cannabis cultivation operations have applied chemical pesticides without proper PPE or safety training. Businesses employing pesticides off­-label will likely find themselves subject to liability claims from workers, as well as consumers, in the relatively near future.

Conclusion

In closing, the bottom line is that applying pesticides off­-label is a violation of state and federal law and could result in criminal and civil sanctions, should regulators and affected parties choose to pursue them.

It must also be noted that off­-label pesticide use threatens the industry as a whole. Point six of the Cole Memorandum states that the federal government will not make the enforcement of the Controlled Substances Act a priority as long as the “exacerbation of (…) public health consequences associated with marijuana use” is prevented. The emergence of a public health problem would be a violation of the Cole Memo ­and it could be argued that the current situation unfolding in Denver is already a violation ­ and could trigger federal intervention against states that have legalized cannabis. In this light, the Denver Department of Environmental Health, which is driving the recalls, has not “launched a campaign against legal cannabis,” as a company recently subject to a recall claimed, but is actually acting as a bulwark against a potentially serious Cole Memo violation that could shutter the entire industry.

Based on the current situation, the cannabis industry must come together to denounce and eliminate off­-label pesticide use. In order to ensure the health of patients, consumers, workers, and the industry itself, we must seize this opportunity to grow without chemicals that are currently illegal, potentially very harmful, and ultimately not even necessary.