Tag Archives: regulator

Is There a Looming Supply Bottleneck in California?

By Aaron G. Biros
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California’s regulated adult use cannabis market has been up and running for around four months now and rumors of a potential supply bottleneck on the horizon are beginning to circulate. There are a number of factors that could have an impact on the cannabis supply in the market, most of which stem from changes in the distribution channels now that the state is implementing new regulations.

Those include a slow rollout in licensing cannabis businesses, new testing requirements, the supply carryover period prior to January 1stas well as new labeling and packaging regulations. In this piece, we are going to examine some of those rumors, see if there might be some truth to them and provide some guidance for what businesses can do to prepare for this.

A Slow Start to Licensing

This one is perhaps the most obvious factor to impact the supply chain in California. Much of the delays in licensing cannabis businesses came from the issue of local control, where businesses needed to get approval from their municipality before getting a state license. In the first month of the new market, it took Los Angeles weeks longer than other counties to begin licensing dispensaries. Whereas San Diego retailers saw a massive influx of customers right away, forcing them to buy up product to meet the high demand. Smaller producers also had trouble getting licenses as quickly as some of the larger ones.

Basically it all boils down to a slow start for the new market, according to Diane Czarkowski, co-founder of Canna Advisors. “The state is requiring businesses to get their local licenses before they can get their state license and that will create a delay in operators being able to bring products to market,” says Czarkowski. She says this is pretty typical of new markets, or when a market experiences dramatic changes quickly. “It could be a brand-new market, like in Hawaii, where the operators were ready with product, but there were no labs to test the products, which caused delays.” In addition to the licensing roll out being slow to start, the temporary licenses initially awarded to businesses are set to expire soon, by the end of April.

Stricter Rules to Come

The same logic goes for the testing regulations. New testing and labeling requirements, according to the Bureau of Cannabis Control regulating the market, will be phased in throughout 2018.

CA cannabis testing chart
California’s plan for phasing in testing requirements.

The state has already phased in cannabinoids, moisture content, residual solvent, pesticide, microbial impurities and homogeneity testing to some extent. On July 1st, the state will add additional residual solvent and pesticide testing as well as foreign material testing. At the end of 2018, they plan on requiring terpenoids, mycotoxins, heavy metals and water activity testing. All of those tests cost money and all of those tests could impact suppliers’ ability to bring product to market. “Oftentimes regulations require different types of testing to be done to products without recognizing that adequately completing those tests requires different methods, equipment, and standards,” says Czarkowski. “Most labs do not have all of the necessary components, and they are very costly. Producers could wait weeks to get test results back before they know if they can sell their products.”

Back when we spoke with Josh Drayton, deputy director of the California Cannabis Industry Association, about the upcoming changes to the California market, he voiced his concerns with the coming testing rules. “A lot of testing labs are concerned they are unable to test at the state’s threshold for some of these contaminants and pesticides; the detection limits seem very low,” says Drayton. “The testing portion will take years to work out, I am sure we will remove and add different pesticides and contaminants to the list.” California’s testing industry is, however, capable of adapting to changing rules, as they’ve done in the past on more than one occasion. It should be noted that many labs in the state are on the cutting edge of testing cannabis, working with The Bureau to implement the new rules.

roybingham
Roy Bingham, CEO of BDS Analytics

Cannabis products made prior to December 31st, 2017, did not need to comply with the stricter testing rules that are coming in the next few months. This carryover period allowed dispensaries to have products on the shelves when the new market launched in the beginning of 2018. Retailers knew this rule meant they needed to stockpile product in the event of a supply bottleneck, and it appears much of that product is now sold and running out, according to Roy Bingham, founder and chief executive officer of BDS Analytics. “The true impact of licenses is starting to be felt since the carryover from December buying prior to the licensed market has been sold,” says Bingham. “Some of the major brands have consciously not applied for licenses. Some of that has to do with the flexibility the government has given them to wait.”

A fourth reason for a potential bottleneck could also come from packaging and labeling rules. “There will have to be many modifications to products to ensure they follow the new potency regulations, and many formulations will have to be modified in order to meet new regulations,” says Czarkowski. Distributor licenses, according to The Bureau, have a number of compliance documentation requirements, such as arranging for all product testing, quality assurance and packaging and label accuracy. Everything has to be packaged before it gets to a dispensary, which is a new rule California businesses need to comply with.

Pricing is the Indicator

There are a handful of reasons why prices could increase; some of them are more defined than others, the biggest factor being the tax burden passed on to consumers, where reports showed up to a 40% increase from last year. A price increase in the future could also come from The Bureau implementing testing regulations throughout 2018, as mentioned previously.

If prices were to surge enormously and very quickly, that might be an indicator that a shortage is fast approaching. A dramatic increase in price over this year could squeeze margins for smaller producers, forcing retailers to pass that burden on to consumers as well.“So yes, the rumors are true.”

According to Roy Bingham, there has been a significant increase in pricing in all categories at the retail level. “In January and February, we are seeing about 10% increases per month in average retail prices,” says Bingham. “If we look at concentrates in California during 2017, they averaged about $34 by the end of the year, whereas it was about $31 at the start of 2017. So in January, prices have increased up to $38, which is a bit above trend, but in fact we were seeing a trend upwards before January 1st as well.” Comparing that with edibles pricing, Bingham says we see a clear jump at the start of 2018. “It was basically flat in 2017, averaging $14 roughly almost straight-line across, dipped in December, then in January it jumped to $17 and then to $18 in February, a big increase and significantly more than concentrates,” says Bingham. He also says flower was hovering around $9 per gram in December 2017, but surged above $10 in February 2018.

According to Cannabis Benchmarks, the California wholesale averages surged in the summer of 2017 up to $1,631 by September, then reached their lowest point in December, with their spot index at $1,368. The Cannabis Benchmarks report underlines some important reasons for the changes in pricing, but they also attribute it to the new licensing system.

“Increasing operating expenses for businesses preparing to enter California’s licensed system in 2018 were key to propping up supply side rates in the first six months of 2017. New compliance requirements were being instituted to varying degrees by local governments, while market participants warily eyed draft regulations from state officials for guidance as to how to prepare their sites and facilities to meet under-construction regulatory mandates.”

Their report highlights some very important aspects of the supply chain. “Again, it is likely that the increased costs faced by operators up and down the supply chain exert some upward pressure on wholesale rates, preventing them from steep year-over-year declines that were observed in some of the other major Western markets,” reads the Cannabis Benchmarks report.

So How Can Businesses Prepare?

Well to start, producers should make sure their operations and product are clean and safe. Making sure your product will pass a pesticide test should be top of mind. Dispensaries should also be wise in selecting their suppliers, performing supplier quality audits or some form of verification that they meet your standards is key in a consistent supply chain.

Dr. Jon Vaught, chief executive officer of Front Range Biosciences, believes tissue culture could be a viable solution for some California producers. Using tissue culture, as a form of propagation instead of mothers and clones can be cleaner, cheaper and more efficient, thus allowing growers to keep up with demand and prevent a shortage.

Dr. Jon Vaught headshot
Dr. Jon Vaught, CEO of Front Range Biosciences

Dr. Vaught says growers could look to tissue culture as a means to “mitigate risk to their supply chain and mitigate the risk of potential loss and improve their ability to efficiently grow their plant.” Maintaining a disease-free, sterile environment is a huge advantage in the cannabis market. “The real use of tissue culture is to provide disease free, clean, certified material, that has gone through a QA program,” says Dr. Vaught. “In greenhouses, the ability to control your environment is also critical because your margin of error is high. Variations in sunlight, weather, humidity all of these things have an impact in your plants. Technology can help monitor this.”

We’ve covered the basics of tissue culture previously on CIJ, with Dr. Hope Jones chief science officer of C4 Laboratories. She echoes many of Dr. Vaught’s points, firmly believing that, having existed for decades, tissue culture is an effective propagation tool for advanced breeders or growers looking to scale up.It is a complex supply chain that requires systems thinking.

It is important to note they don’t think growers should try this at home. Work with professionals, get the necessary funding, the training and facilities required if this is a project that interest you. “There’s a pretty big barrier to entry there,” Dr. Vaught urges. “The ability to manage thousands or millions of plants in a greenhouse increases risk, whereas in the lab, you’ve got a safe, secure, sterile environment, reducing risk of disease, making things easier to manage. The producers most successful at large scale are controlling those variables to the T.”

Ultimately, one segment of the market can’t prevent a bottleneck. It is a complex supply chain that requires systems thinking. Regulators need to work with producers, manufacturers, retailers, distributors, patients, consumers and laboratories to keep an eye on the overall supply chain flow.

Diane Czarkowski says the California market should prepare for this now if they haven’t already. “We have seen supply issues in every market going through a change. Other potential bottlenecks will occur because former distribution channels will be required to change,” says Czarkowski. “So yes, the rumors are true.”

HACCP

Hazard Analysis and Critical Control Points (HACCP) for the Cannabis Industry: Part 1

By Kathy Knutson, Ph.D.
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HACCP

Hazard Analysis and Critical Control Points (HACCP) Defined

Farm-to-fork is a concept to describe the control of food safety starting in the fields of a farm and ending with deliciousness in my mouth. The more that is optimized at every step, the more food safety and quality are realized. Farm-to-fork is not a concept reserved for foodies or “eat local” food campaigns and applies to all scales of food manufacture. HACCP is like putting the last piece of a huge puzzle in the middle and seeing the whole picture develop. HACCP is a program to control food safety at the step of food processing. In states where cannabis is legal, the state department of public health or state department of agriculture may require food manufacturers to have a HACCP plan. The HACCP plan is a written document identifying food safety hazards and how those hazards are controlled by the manufacturer. While there are many resources available for writing a HACCP plan, like solving that puzzle, it is a do-it-yourself project. You can’t use someone else’s “puzzle,” and you can’t put the box on a shelf and say you have a “puzzle.”

HACCP is pronounced “ha” as in “hat” plus “sip.”

(Say it aloud.)

3-2-1 We have liftoff.

The history of HACCP starts not with Adam eating in the garden of Eden but with the development of manned missions to the moon, the race to space in the 1950s. Sorry to be gross, but imagine an astronaut with vomiting and diarrhea as a result of foodborne illness. In the 1950s, the food industry relied on finished product testing to determine safety. Testing is destructive of product, and there is no amount of finished product testing that will determine food is safe enough for astronauts. Instead, the food industry built safety into the process. Temperature was monitored and recorded. Acidity measured by pH is an easy test. Rather than waiting to test the finished product in its sealed package, the food industry writes specifications for ingredients, ensures equipment is clean and sanitized, and monitors processing and packaging. HACCP was born first for astronauts and now for everyone.HACCP

HACCP is not the only food safety program.

If you are just learning about HACCP, it is a great place to start! There is a big world of food safety programs. HACCP is required by the United States Department of Agriculture for meat processors. The Food and Drug Administration (FDA) requires HACCP for seafood processing and 100% juice manufacture. For all foods beyond meat, seafood and juice, FDA has the Food Safety Modernization Act (FSMA) to enforce food safety. FSMA was signed in 2011 and became enforceable for companies with more than 500 employees in September of 2016; all food companies are under enforcement in September 2018. FSMA requires all food companies with an annual revenue greater than $1 million to follow a written food safety plan. Both FDA inspectors and industry professionals are working to meet the requirements of FSMA. There are also national and international guidelines for food safety with elements of HACCP which do not carry the letter of law.

The first step in HACCP is a hazard analysis.

Traditionally HACCP has focused on processing and packaging. Your organization may call that manufacturing or operations. In a large facility there is metering of ingredients by weight or volume and mixing. A recipe or batch sheet is followed. Most, but not all, products have a kill step where high heat is applied through roasting, baking, frying or canning. The food is sealed in packaging, labeled, boxed and heads out for distribution. For your hazard analysis, you identify the potential hazards that could cause injury or illness, if not controlled during processing. Think about all the potential hazards:

  • Biological: What pathogens are you killing in the kill step? What pathogens could get in to the product before packaging is sealed?
  • Chemical: Pesticides, industrial chemicals, mycotoxins and allergens are concerns.
  • Physical: Evaluate the potential for choking hazards and glass, wood, hard plastic and metal.

The hazards analysis drives everything you do for food safety.

I cannot emphasize too much the importance of the hazard analysis. Every food safety decision is grounded in the hazard analysis. Procedures will be developed and capital will be purchased based on the hazard analysis and control of food safety in your product. There is no one form for the completion of a hazard analysis.

HACCP risk matrix
A risk severity matrix. Many HACCP training programs have these.

So where do you start? Create a flow diagram naming all the steps in processing and packaging. If your flow diagram starts with Receiving of ingredients, then the next step is Storage of ingredients; include packaging with Receiving and Storage. From Storage, ingredients and packaging are gathered for a batch. Draw out the processing steps in order and through to Packaging. After Packaging, there is finished product Storage and Distribution. Remember HACCP focuses on the processing and packaging steps. It is not necessary to detail each step on the flow diagram, just name the step, e.g. Mixing, Filling, Baking, etc. Other supporting documents have the details of each step.

For every step on the flow diagram, identify hazards.

Transfer the name of the step to the hazard analysis form of your choice. Focus on one step at a time. Identify biological, chemical and physical hazards, if any, at that step. The next part is tricky. For each hazard identified, determine the probability of the hazard occurring and severity of illness or injury. Some hazards are easy like allergens. If you have an ingredient that contains an allergen, the probability is high. Because people can die from ingestion of allergens when allergic, the severity is high. Allergens are a hazard you must control. What about pesticides? What is the probability and severity? I can hear you say that you are going to control pesticides through your purchasing agreements. Great! Pesticides are still a hazard to identify in your hazard analysis. What you do about the hazard is up to you.

OLCC-Logo

Audit Finds Oregon Lacking Regulatory Oversight and Proper Security

By Aaron G. Biros
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OLCC-Logo

Last week, Oregon Secretary of State Dennis Richardson published his office’s audit of The Oregon Liquor Control Commission (OLCC). The audit uncovered a number of inadequacies with the regulatory agency, most notably the problems with their tracking system, designed to prevent cannabis form being sold on the black market.

The report highlights the need for Oregon to implement a more robust tracking system, citing reliance on self-reporting, overall poor data quality and allowing untracked inventory for newly licensed businesses. The audit also found an insufficient number of inspectors and unresolved security issues. According to The Oregonian, the OLCC only has 18 inspectors, roughly one for every 83 licensed businesses.

Auditors also found inadequacies in the application system, saying the OLCC doesn’t monitor third-party service providers and doesn’t have a process in place for reconciling data between the licensing and tracking systems. The audit found there is a risk that decisions made for the program could be based on unreliable data. It also found a risk of unauthorized access to the systems, due to a lack of managing user accounts.

Oregon Secretary of State Dennis Richardson
Oregon Secretary of State Dennis Richardson

This audit’s publication is very timely. Most notably because U.S. Attorney Billy Williams, who called Oregon’s black market problem “formidable,” convened a summit this week to examine how Oregon can prevent cannabis being exported to other states. According to the Oregonian, Williams said Oregon has an “identifiable and formidable overproduction and diversion problem.” The audit’s findings highlighting security issues are also very timely, given that in the same week, Oregon’s neighbor to the North, Washington, experienced a security breach in its own tracking system.

The problems with the Oregon tracking system’s security features are numerous, the audit says. They found that the OLCC lacks a good security plan, IT assets aren’t tracked well, there are no processes to determine vulnerabilities, servers and workstations not using supported operating systems and a lack of appropriately managing antivirus solutions. “Long-standing information security issues remain unresolved, including insufficient and outdated policies and procedures necessary to safeguard information assets,” reads the report’s summary.

The audit proposes 17 recommendations for the state to bolster its regulatory oversight. Those recommendations intend to address undetected compliance violations, weaknesses in application management, IT security weaknesses and weaknesses in disaster recovery and media backup testing. You can read the full audit here.

Laura Bianchi
Soapbox

Jeff Sessions’ Latest Moves Should be a Wake-Up Call for the Cannabis Industry

By Laura A. Bianchi
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Laura Bianchi

The legal cannabis industry was recently rocked to its core by the announcement that Attorney General Jeff Sessions would be rescinding the so-called “Cole memo” and several other Obama-era legal directives suggesting the federal government would leave state-by-state cannabis reforms more or less alone. Suddenly, it seemed the entire cannabis movement was in jeopardy. Laws legalizing medical and recreational cannabis could be at risk. A booming industry predicted to be worth $50 billion annually by 2026 could instead be going down in flames.

Here’s the good news: As a business transactions attorney who’s been working in the cannabis industry for eight years, I don’t see any cause for panic. The Cole memo and the other directives the Justice Department are rescinding were not laws, orders or even legal precedents – they were simply legal guidance, and murky at that. The memos provided guidance to federal prosecutors regarding cannabis enforcement under federal law, suggesting that federal prosecutors not focus resources on state-legal cannabis operations that weren’t interfering with other federal priorities, such as preventing the distribution of cannabis to minors and preventing revenue from the sales from going to criminal enterprises, gangs and cartels. Yes, federal prosecutors could take Sessions’ recent moves to mean it’s open season on medical and recreational cannabis businesses. But with medical cannabis programs of one form or another up and running in 29 states and Washington D.C., and recreational cannabis now legal in eight states and Washington D.C., dismantling the entire legal cannabis industry would require a Herculean federal effort that would come at the expense of a cornerstone of the Republican Party now in power: The vital importance of states’ rights.The best way to stay on top of those rules? Form relationships with your state program regulators

In other words, I don’t see the termination of the Cole memos as the end of the nascent cannabis industry. But I do think the development should be a wake-up call for all those people in the cannabis industry who have been playing fast and loose with their business operations. After all, if federal prosecutors do decide to make examples of certain cannabis operations, they’re going start with those who are not operating within the confines of the applicable state rules and regulations.  Any business that smells even slightly of tax evasion, interstate trafficking or the allocation of cannabis-derived revenue to benefit a criminal enterprise will end up at the top of that target list.

So how should well-meaning cannabis operators stay off the feds’ radar? Simple: Follow all the rules.

Unless you want orange to be your new black, you can’t afford to be sloppy with your business structure and financial records.For starters, you need a CPA who’s not just at the top of their game, but who also understands the very specific – and potentially debilitating – nuances of cannabis-specific tax liabilities. That’s because thanks to a quirk in the tax code called IRS section 280E, cannabis companies are utterly unique in that they are not allowed to deduct expenses from their business income, save for the costs of goods sold. You want an accountant who thoroughly grasps this issue, so they can help you plan for and (to the extent possible) minimize your tax liability. And you want to address such matters before you start to realize positive revenue, so you’re ready to handle an effective tax rate that can be upwards of 70 percent. Last I checked, the IRS doesn’t consider “But I can’t afford to pay my taxes!” a valid excuse.

Along the same lines, you need a business corporate attorney who’s well-versed in the world of cannabis. That’s because while it might seem exciting to jump headlong into the cannabis green rush, you’re not going to get very far if you don’t deal with the boring stuff first. I’m talking about start-up financing strategies, business contracts and agreements, profit and loss forecasts, cash-flow analysis, and long-term financial plans. Properly structuring your business from the get-go isn’t just important if you ever plan to seek capital or sell your business. It’s also necessary if you want to keep the feds happy. In other industries, regulators might cut first-time business owners some slack. Not so in cannabis. Unless you want orange to be your new black, you can’t afford to be sloppy with your business structure and financial records.

Jeff Sessions and Eric Holder
AG Jeff Sessions (left), the man responsible for the recent uptick in worries

Finally, make sure you’re playing by all the cannabis rules, regulations and requirements of your state and jurisdiction. While this suggestion might seem like a no-brainer, far too often cannabis brands hire hotshots from Fortune 500 companies who don’t know anything about cannabis regulations and how they apply to their business.

The best way to stay on top of those rules? Form relationships with your state program regulators. Here in Arizona, I am in constant contact with our regulators discussing nuances and new business concepts for which the rules are unclear, convoluted or simply silent. Working with the enforcers might not come naturally to many folks in the cannabis business, but we’re dealing with a new and evolving industry where there’s little or no business, regulatory or judicial precedent. We’re all in this together.

It’s exciting to be at the bleeding edge of a bold and booming new industry like cannabis, but to do so safely and legally, cannabis industry pioneers need to make sure they’re striking the right balance between daring innovation and sensible business security.

We shouldn’t expect Jeff Sessions to launch a new army of prohibition agents around the country to kick down doors of cannabis businesses. But it wouldn’t be a bad idea for cannabis entrepreneurs to start acting like he might.

Growing Pains a Month Into California’s Market Launch

By Aaron G. Biros
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For about a month now, California’s adult use market has been open for business and the market is booming. About thirty days into the world’s largest adult use market launch, we are beginning to see side effects of the growing pains that come with adjusting the massive industry.

Consumers are also feeling sticker shock as the new taxes add up to a 40% increase in price.While the regulatory and licensing roll out has been relatively smooth, some municipalities are slower than others in welcoming the adult use cannabis industry. It took Los Angeles weeks longer than other counties to begin licensing dispensaries. Meanwhile, retailers in San Diego say the first month brought a huge influx of customers, challenging their abilities to meet higher-than-expected demand.

Businesses are struggling to deal with large amounts of cash, but California State Treasurer John Chiang may have a solution in store. Yesterday, his department announced they are planning to create a taxpayer-backed bank for cannabis businesses.

Reports of possible supply shortages are irking some businesses, fearing that the state hasn’t licensed enough growers and distributors to handle the high demand. Consumers are also feeling sticker shock as the new taxes add up to a 40% increase in price.

CA cannabis testing chart
California’s plan for phasing in testing requirements.

In the regulatory realm, some are concerned that a loophole in the rules allows bigger cultivation operations to squeeze out the competition from smaller businesses. The California Growers Association filed a lawsuit against the California Department of Food and Agriculture to try and close this loophole, hoping to give smaller cultivators a leg up before bigger companies can dominate the market.

The Bureau of Cannabis Control (known as just “The Bureau”) began holding meetings and workshops to help cannabis businesses get acquainted with the new rules. Public licensing workshops in Irvine and San Diego held last week were designed to focus on information required for licensing and resources for planning. The Bureau also held their first cannabis advisory committee meeting, as well as announcing new subcommittees and an input survey to help the Bureau better meet business needs.

On the lab-testing front, the state has phased in cannabinoids, moisture content, residual solvent, pesticide, microbial impurities and homogeneity testing. On July 1, the state will phase in additional residual solvent and pesticide testing in addition to foreign material testing. At the end of 2018, they plan on requiring terpenoids, mycotoxins, heavy metals and water activity testing as well.

NACB Releases Packaging and Labeling Standards for Public Review

By Aaron G. Biros
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Last week, the National Association of Cannabis Businesses (NACB) announced the publication of their Packaging and Labeling National Standard, initiating a comment period for public review. The NACB, which launched in June of 2017, is the first-ever self-regulatory organization (SRO) for cannabis businesses in the United States.

According to the press release, the Packaging and Labeling National Standard, the first standard for them to publish, is designed to help protect consumers and show regulators and financial institutions that members of NACB operate ethically and responsibly.

Andrew Kline, president of NACB

According to Andrew Kline, president of NACB, the standard is based on regulators’ priorities, among other stakeholder inputs. “The NACB believes that self-regulation is the most effective course of action for our members to control their own destiny in the face of regulators’ growing need to intervene,” says Kline. “The creation and adoption of national, voluntary standards that are aligned with regulators’ priorities takes input from government, NACB members, and subject matter experts into careful consideration. Through this process, the SRO identified product packaging and labeling as our first priority because it impacts so many issues related to health and safety.”

Here are some of the major areas the standard addresses, from the press release:

  • Child-resistant packaging guidelines for all cannabis products
  • Consistent labeling that identifies the cannabis product’s origin, cultivator and processor
  • Inclusion of warning statements regarding health risks associated with cannabis consumption, such as advising consumers to not drive or operate heavy machinery while using the product, and that the intoxicating effects of the product may be delayed after consumption
  • Avoiding packaging and labeling that appeal to minors
  • Requirements and methods for listing all ingredients present in the product
  • Inclusion of major food allergen warnings and information on cannabis edibles based upon U.S. Food & Drug Administration guidelines
  • Guidelines on how to address health and medical claims for cannabis products

The public review and comment period lasts until February 21st. During that time, every comment submitted will be reviewed and could impact the final language of the standard. Prior to adopting the new standard, they write a final draft after the comment period and bring it to members for a final vote.

Once the final standard is in place, the NACB enforces the standard with their members. If a member doesn’t comply, they can be removed from the organization or penalized.

Towards the end of the press release, they hint at news coming in 2018 for their members. “To help aid members in complying with the requirements of state governments and the NACB’s National Standards, the NACB expects to launch a technology solution exclusively for members in 2018,” reads the press release. “The technology platform is also expected to help members meet the rigorous due diligence required by financial institutions and business partners, by creating an auditable ledger of compliance and financial records.”

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?”

EVIO Logo

EVIO Labs Expands To Florida

By Aaron G. Biros
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EVIO Logo

Currently, there are no lab testing regulations for Florida’s medical cannabis market. Chris Martinez, co-founder and chief operating officer of EVIO Labs Florida, a veteran-owned business, is looking to change that.

Chris Martinez, co-founder and president of EVIO Labs Florida

When Martinez co-founded EVIO Labs Florida, he saw the need for a dedicated cannabis lab to ensure safety and quality of medicine for patients in the state. Partnering with EVIO Labs to accomplish this goal, Martinez secured a 5,500 sq. ft. facility in Broward County to test for potency, pesticides, microbial contaminants, terpenes, residual solvents and heavy metals. Their lab, a first of its kind in the industry, qualifies as a true pharmaceutical-grade clean room. This week, Martinez also secured their 2nd laboratory location in the City of Gainsville, where they will test for potency, microbials, terpenes and residual solvents. And he isn’t doing it on the cheap. “Our Broward lab is powered by Shimadzu with over $1.2M in the latest testing equipment utilizing LCMS technology with the world’s fastest polarity switching time of 5 m/sec and scan speeds of 30,000 u/sec with UF Qarray sensitivity 90 times that of previously available technologies,” says Martinez.

Martinez, an entrepreneur at heart, started the lab with a team of experts to become the first completely cannabis-focused laboratory in Florida. Jorge Segredo, their head chemist and quality assurance director, has over 18 years of experience in the development of nutraceutical and pharmaceutical products under ISO and FDA accreditation. Segredo has helped launch three independent FDA-accredited laboratories and has extensive knowledge of HPLC, GCMS, LCMS, ICPMS technologies and development/validation of testing methods and procedures. Cynthia Brewer, their director of operations, was an active participant in the 2017 state legislative session and has been an advocate for medical cannabis, working with legislators on a suitable framework to increase patient access to cannabis.

The EVIO team is using instruments from Shimadzu

EVIO is one of the nation’s leaders in cannabis testing, research science and advisory services. It is an evolving network of laboratories with nine EVIO cannabis laboratories operating in five different states: Oregon, Colorado, Massachusetts, Florida and California. “After speaking with industry chemists around the country for months, the EVIO name was constantly brought up in conversation,” says Martinez. “When we spoke with the EVIO Team it was an easy decision for us to partner.” He says Lori Glauser, chief operating officer of EVIO, and William Waldrop, chief executive officer of EVIO, are truly visionaries in the cannabis industry.

According to Martinez, their licensing agreement with EVIO Labs (OTC:SGBYD) marked a first for the publicly traded company with exclusivity in the Florida market. The agreement includes proprietary testing methodologies, operating procedures, training and support.

In addition to testing cannabis for safety and quality, they are launching a technology platform called MJ Buddy, essentially a software tool that takes efficacy feedback from patients and uses testing and genetic data they gather from EVIO Labs across the country. “This will provide real data to the cannabis industry as to the medical benefits for thousands of patients in relation to the genotype and cannabinoid profiles of their medicine,” says Martinez.

Of the states that have legalized some form of cannabis, a large number of them have some lab testing regulations on the book, with some more comprehensive than others. Martinez says he hopes the Florida Department of Health, Office of Medical Marijuana Use follows some of the more thorough state programs, such as Oregon. His team has compiled a set of documents for regulators with recommendations for regulating the lab testing industry.

Without any regulations on paper, it is up to businesses to produce safe and quality medicine, without any oversight. EVIO Labs Florida follows FDA Good Laboratory Practices, has an ISO 17025:2005 accreditation pending, and is working on TNI 2016 accreditation.

When discussing what he wants to see happen with Florida’s regulatory framework, Martinez says the rules need to be specific to Florida. For example, due to the climate being so humid, microbial contaminant testing for things like yeast and mold will be particularly imperative. Because processing methods like butane and alcohol extraction are legal, he emphasizes the need for comprehensive residual solvents testing. “The most important regulation would be to have the laboratories select the samples at the MMTC facility and have the state randomly verify laboratory results to ensure accurate unbiased testing,” says Martinez.

In addition to that, he hopes their pesticide thresholds will be realistic and based on actual science. “We believe the public should receive carcinogenic data for products that are inhaled,” says Martinez. “Chemicals may be introduced into the processing of cannabis to vape liquid that may cause harm. This is important information for public health and communication of the risk related to exposure to such materials.” Martinez says EVIO Labs Florida was founded on the belief that through technology and science we can increase safety and patient outcomes.

The Future of California’s Regulations: Q&A with Josh Drayton

By Aaron G. Biros
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Josh Drayton, deputy director of the California Cannabis Industry Association, has an extensive career in local and state-level politics, with his origins in Humboldt County as a political organizer. As a coffee shop owner about ten years ago in Humboldt, he let city council candidates use his space for community engagement, which eventually steered him towards a career in politics. As a heavily involved resident of Northern California and an advocate in local and state matters, he came to understand cannabis as a strong economic driver for the region and beyond.

Drayton saw firsthand how local economies benefit from cannabis as a source of income, economic activity, and providing occupational opportunities for many families in Humboldt County. After running a handful of local campaigns in the Humboldt region, Drayton served as deputy director for a state senate campaign in Riverside.

Josh Drayton, deputy director of the CCIA

Towards the end of his tenure with the Democratic Party in California, the state legislature began working on medical cannabis regulations. “As we saw those regulations moving through, cities and counties began to ban cannabis throughout the state, which was a very unintended consequence,” says Drayton. “The goal was to put regulations forward that would create a framework for the industry to survive and function under, but they were not very fond of cannabis at the time. It was clear that we had a lot of work to do.” Politicians shying away from cannabis issues and a lack of real representation in the legislature for those stakeholders drove him to leave the state’s senate for the California Cannabis Industry Association (CCIA).

In January of 2016, he jumped on board with the CCIA as their deputy director. Ahead of the California Cannabis Business Conference, September 21-22 in Anaheim, we sit down with Drayton to hear his take on the future of California’s cannabis regulations.

CannabisIndustryJournal: Give us a quick update on the regulatory framework in California and the changes we should expect.

Josh Drayton: One of the biggest challenges that California has faced has been the reconciliation of medical regulations with adult use regulations. Although California had medical cannabis legalized in 1996, we did not get those regulations put forward until 2015. That was called the Medical Cannabis Regulation and Safety Act. That was approved by the state legislature and signed by the governor into law. It was created in the legislature. When Prop 64 passed, the Adult Use of Marijuana Act, in November of 2016, it was passed through by a voter initiative. Any time that a piece of legislation goes to the voters, it trumps any legislation or regulations written by the state legislature. The real work has been to reconcile these two pieces of legislation into one regulatory structure. With that being said, we saw the initial trailer bill, attempting to reconcile these regulatory structures. That trailer bill is meant to address the new framework. Currently, we are waiting for the second viewing of the updated trailer bill SB 94 with all current amendments. Then we are anticipating those in the next couple weeks and we will see the regulations that will affect all these changes by November.

CIJ: How strong will local and municipal control be in the future?

Josh: It is incredibly strong and it is meant to be. I will say that California is like its own country. In Northern California, what they are willing to accept is very different in comparison to Southern California. Every city and county still has the ability to fully ban adult use and they can create and draft their own ordinances and regulations as long as it doesn’t go above state requirements. They can craft an ordinance to fit the needs of their city or county. Lets say you are in a rural area, delivery services might be important for patient access. Some areas might not allow brick and mortar dispensaries, and all that control lies in the cities and counties.

CIJ: Will there be a dosing limit for patients buying infused products? What about for adult use?

Josh: For adult use, there is going to be a limitation. Every edible has a maximum potency of 10mg of THC. For example, a chocolate bar can have a maximum of 100mg [of THC] but must be perforated in to 10mg pieces.

We have been advocating for, and what has been a priority for CCIA, is a lift of any sort of limits on medical infused products. Many patients have a higher threshold or tolerance and they may need 100mg and we don’t want them eating an entire chocolate bar to get that. We are anxiously awaiting the new trailer bill to see if we have been able to lift that concentration limit.

CIJ: Some have said the first draft of lab testing rules is extreme and overreaching. Can you speculate how those have been modified?

Josh: The lab testing is a huge educational issue for the industry and regulators. No state right now has been able to fully analyze the effects of different pesticide levels for a product that is smoked. We are basing all of our standards currently on food consumption. A lot of testing labs are concerned they are unable to test at the state’s threshold for some of these contaminants and pesticides; the detection limits seem very low. The testing portion will take years to work out, I am sure we will remove and add different pesticides and contaminants to the list. But again, the data and research isn’t fully there. There is a big push across the board that we will be able to do more research and testing so that the future of regulations can reflect reality, and ensure that consumer safety is priority.

CIJ: What do you think of the lack of residency requirement? When Oregon lifted it, outside investors flocked to the market. How might that impact local, California ownership and smaller businesses?

Josh: Well I do think that is a concern across the board. That is something that cities and counties have been adding to their requirements for the matrix of items needed to get a license. I think there is a very gray area when looking at investors opposed to operators. At what threshold does an investor become an owner? And if that person is from outside the state, how will that reflect on the evolution of the industry? It is a concern. Keeping limitations on the size of outdoor cultivation might help limit folks from outside the state coming into that arena. After living in Humboldt County for years, and living next to Mom and Pop growers for a long time, I don’t want to see them displaced by businesses coming from another area. We have been doing this a long time and I believe we have the best operators in the world.

CIJ: How is the CCIA helping businesses gear up for changing regulations?

Josh: Well one of our biggest areas of focus is education. Educating our own industry is one of the biggest parts in making sure the industry will be successful in this regulated market. Our legislative committee will take a position of support or opposition, which goes to our board, and those recommendations go to the state. The manufacturing committee has worked very closely with Lori Ajax [director of the Bureau of Cannabis Regulation] and her office, to educate on a variety of areas, guiding the way for state departments on how to properly regulate the industry. We have a Diversity and Inclusion Committee, Retail/Delivery, Testing, Distribution and Agricultural committees; across the board our committees create white papers that we submit to the regulatory departments of the state. We take regulatory officials on tours of facilities to get a hands-on view of what they are regulating. They have been speaking with scientists and growers, who often have a better understanding of current industry standards. We see these tours as very helpful. We have brought groups of regulators from LA County, Long Beach, Napa, Alameda and many others on tours of Bay Area commercial manufacturing facilities, dispensaries and nurseries. They have a lot of questions and we want to make sure we are a resource for them. Putting folks in touch with the right people and, in moving forward with this process, in an educated manner. Cannabis is a foreign language to many people and I get that.

CIJ: If you have one recommendation for regulators, what would that be?

Josh: My recommendation to regulators: do not over-tax this industry. Do not make taxation the priority for regulation. Over-taxation will strengthen the illicit market and that is not the goal. We need to make sure the taxes are reasonable to encourage businesses to operate in this market, not in the illegal one. If cities decide to ban, they need to know they can be hubs for illicit activity. Cities with bans might draw the illicit market because illegal operators won’t have to pay taxes or license fees. It is a long play, but responsible taxation is the best path to draw people out of this illicit market. We want to help protect public safety and health, safe medicine, safe products and keep cannabis out of the hands of children.