An educational and networking event for cannabis safety and quality solutions: Innovative Publishing and Cannabis Industry Journal are pleased to present the first annual Cannabis Quality Conference & Expo (CQC). The conference will take place October 1-3, 2019, hosted at the Renaissance Schaumburg Convention Center in Schaumburg, Illinois.
The inaugural CQC will consist of two separate tracks: The Cannabis Labs track, focused on all things cannabis lab testing, and the Cannabis Quality track, focusing on quality in cannabis product manufacturing.
Sharing an exhibit hall and meeting spaces right alongside the Food Safety Consortium Conference & Expo, the CQC allows cannabis professionals to interact with senior level food quality and safety professionals, as well as regulators. Visit with exhibitors to learn about cutting-edge solutions, explore two high-level educational tracks for learning valuable industry trends, and network with industry executives to find solutions to improve quality, efficiency and cost effectiveness in a quickly evolving cannabis marketplace.
Take advantage of this chance to connect with cannabis industry and food safety professionals in the Greater Chicago Area. Don’t miss this opportunity to network with hundreds of industry stakeholders, get the latest on regulatory developments and see the newest technology disrupting the cannabis space.
By Ravi Kanipayor, Christian Bax, Dr. George Anastasopoulos No Comments
As state cannabis regulatory frameworks across the country continue to evolve, accreditation is becoming increasingly important. Because it provides consistent, turnkey standards and third-party verification, accreditation is quickly emerging as an important tool for regulators. For cannabis testing laboratories, this trend has been especially pronounced with the increasing number of states that require accreditation to ISO/IEC 17025.
As of 2017 there were nearly 68,000 laboratories accredited to ISO/IEC 17025, making it the single most important benchmark for testing laboratories around the world. ISO/IEC 17025:2005 specifies the general requirements for the competence to carry out tests including sampling. It covers testing performed using standard methods, non-standard methods and laboratory-developed methods. It is applicable to all organizations performing tests including cannabis labs. The standard is applicable to all labs regardless of the number of personnel or the extent of the scope of testing activities. Developed to promote confidence in the operation of laboratories, the standard is now being used as a key prerequisite to operate as a cannabis lab in many states.
There are currently 26 states in the United States (also Canada) that require medical or adult-use cannabis to be tested as of February 2019. Of those states, 18 require cannabis testing laboratories to be accredited – with the vast majority requiring ISO/IEC 17025 accreditation. States that require testing laboratories to attain ISO/IEC 17025 accreditation represent some of the largest and most sophisticated cannabis regulatory structures in the country, including California, Colorado, Maryland, Massachusetts, Michigan, Nevada and Ohio. As a consequence, many cannabis testing laboratories are taking note of recent changes to ISO/IEC 17025 standards.
ISO/IEC 17025 was first issued in 1999 by the International Organization for Standardization. The standard was updated in 2005, and again in 2017. The most recent update keeps many of the legacy standards from 2005, but adds several components – specifically requirements for impartiality, risk assessment and assessing measurement uncertainty. The remainder of this article takes a deeper dive into these three areas of ISO/IEC 17025, and what that means for cannabis testing laboratories.Objectivity is the absence or resolution of conflicts of interest to prevent adverse influence on laboratory activities.
ISO/IEC 17025:2005 touched on an impartiality requirement, but only briefly. The previous standard required laboratories that belonged to organizations performing activities other than testing and/or calibration to identify potential conflicts of interest for personnel involved with testing or calibration. It further required that laboratories had policies and procedures to avoid impartiality, though that requirement was quite vague.
ISO/IEC17025:2017 emphasizes the importance of impartiality and establishes strict requirements. Under the new standard, labs are responsible for conducting laboratory activities impartially and must structure and manage all laboratory activities to prevent commercial, financial or other operational pressures from undermining impartiality. The definitions section of the standard defines impartiality as the “presence of objectivity.” Objectivity is the absence or resolution of conflicts of interest to prevent adverse influence on laboratory activities. For further elaboration, the standard provides similar terms that also convey the meaning of impartiality: lack of prejudice, neutrality, balance, fairness, open-mindedness, even-handedness, detachment, freedom from conflicts of interest and freedom from bias.
To comply with the new standard, all personnel that could influence laboratory activities must act impartially. ISO/IEC 17025:2017 also requires that laboratory management demonstrate a commitment to impartiality. However, the standard is silent on how labs must demonstrate such commitment. As a starting point, some cannabis laboratories have incorporated statements emphasizing impartiality into their employee handbooks and requiring management and employee training on identifying and avoiding conflicts of interest.
Both the 2005 and 2017 versions contain management system requirements. A major update to this is the requirement in ISO/IEC 17025:2017 that laboratory management systems incorporate actions to address risks and opportunities. The new risk-based thinking in the 2017 version reduces prescriptive requirements and incorporates performance-based requirements.
Under ISO/IEC 17025:2017, laboratories must consider risks and opportunities associated with conducting laboratory activities. This analysis includes measures that ensure that:
The lab’s management system is successful;
The lab has policies to increase opportunities to achieve its goals and purpose;
The lab has taken steps to prevent or reduce undesired consequences and potential failures; and
The lab is achieving overall improvement.
Labs must be able to demonstrate how they prevent or mitigate any risks to impartiality that they identify.To comply with ISO/IEC 17025:2017, labs must plan and implement actions to address identified risks and opportunities into management systems. They must also measure the effectiveness of such actions. Importantly, the standard requires that the extent of risk assessments must be proportional to the impact a given risk may have on the validity of the laboratory’s test results.
ISO/IEC 17025:2017 does not require that labs document a formal risk management process, though labs have discretion to develop more extensive methods and processes if desired. To meet the requirements of the standard, actions to address risks can include sharing the risk, retaining the risk by informed decision, eliminating the risk source, pinpointing and avoiding threats, taking risks in order to pursue an opportunity, and changing the likelihood or consequence of the risk.
ISO/IEC 17025:2017 references “risks” generally throughout most of the standard. However, it specifically addresses risks to a laboratory’s impartiality in section 4.1. Note, the new standard requires that labs must not only conduct activities impartially, but also actively identify risks to their impartiality. This requirement is on-going, not annually or bi-annually. Risks to impartiality include risks arising from laboratory activities, from laboratory relationships, or from relationships of laboratory personnel. Relationships based on ownership, governance, shared resources, contracts, finances, marketing, management, personnel and payment of a sales commission or other inducements to perform under pressure can threaten a laboratory’s impartiality. Labs must be able to demonstrate how they prevent or mitigate any risks to impartiality that they identify.
Assessing Measurement Uncertainty With Decision Rules
ISO/IEC 17025:2005 required (only where necessary and relevant) test result reports to include a statement of compliance/non-compliance with specifications and to identify which clauses of the specification were met or not met. Such statements were required to take into account measurement uncertainty and if measurement results and uncertainties were omitted from the statement, the lab was required to record and maintain the results for future reference.
ISO/IEC 17025:2017 requires similar statements of conformity with an added “decision rule” element. When statements of conformity to a specification or standard are provided, labs must record the decision rule it uses and consider the level of risk the decision rule will have on recording false positive or negative test results. Like the 2005 version, labs must include statements of conformity in test result reports (only if necessary and relevant- see 126.96.36.199 (b)). Now, test result reports on statements of conformity must include the decision rule that was employed.
Because many states require ISO/IEC 17025 accreditation for licensing, cannabis testing labs across the country would be well advised to closely monitor the implications of changes in ISO/IEC 17025:2017 related to impartiality, risk assessment and measurement uncertainty. If you run a cannabis testing lab, the best way to ensure compliance is education, and the best place to learn more about the new requirements is from a globally recognized accreditation body, especially if it is a signatory to the International Laboratory Accreditation Cooperation (ILAC) for testing laboratories, calibration laboratories and inspection agencies.
Cannabis Facility Construction (CFC), based in Northbrook, Illinois, has taken a rather unique approach to facility design and building in the cannabis market. According to a press release published today, the company takes unused buildings and remodels them into facilities designed specifically for the cannabis industry.
CFC, which is a division of Mosaic Construction, retrofits unused, abandoned buildings, turning them into cannabis cultivation and processing facilities, as well as dispensaries. According to that press release, they have developed buildings on 28 different facilities to date, covering over 328,970 square feet.
According to Ira Singer, Principal at CFC, they provide a turnkey service for licensed operations to retrofit old buildings, including staying compliant with state cannabis regulations. “Since the cannabis industry is emerging as a growth market, investors need to appreciate there is an art and a science to converting raw materials of cannabis and finished products,” says Singer. “CFC’s medicinal processing centers are outfitted to master the product in all its forms and uses, and to meet all state regulations and local fire and safety codes. Its three-stage approach encompasses its Design-Build expertise for processing facilities; construction management; security infrastructure and planning; and permitting and compliance support.”
For example, they helped investors from Highland Park, Illinois take an unused building in Garden City, Michigan and convert it into a 48,000 square foot cultivation, processing and dispensary facility. CFC also does business with Greenhouse, a medical cannabis company with facilities throughout Illinois.
In retrospect, when the cannabis history books are written, 2018 may come to represent as much of a watershed year as 2014. Much has happened this year, culminating in a situation, much like at the end of the first year of modernization, where great victories have been achieved. But a long road to true acceptance and even basic and much broader medical use still beckons. Even if the new center left ruling coalition party in Luxembourg has just announced that recreational cannabis reform is on its agenda for the next five years.
This is a quick and by no means a full review of both fourth quarter activity globally, and how that ties into gains for the year.
Canada Legalizes Rec Sales
Beyond all the other banner headlines, October 17 will go down in history as the day that Canada switched the game.
Will 1017 replace 420? Not likely. But it is significant nonetheless.
What does this mean for the rest of the industry (besides international border checks and lifetime bans for Canadian executives and presumably others traveling into the U.S. to cannabis industry conferences at present)? For starters, a well-capitalized, public industry which is building infrastructure domestically and overseas like it is going out of style.
This is important for several reasons, starting with the fact that the big Canadian LPs are clearly not counting on supplying Europe from Canada for much longer. Why? The big European grows that were set up last year are starting to come online.
So Does California…
And other significant U.S. states (see Massachusetts this month and Michigan) are following suit. However the big issue, as clearly seen at least from Canada and Europe, is there is no federal reform in sight. That opens up a raft of big complications that so far, most U.S. firms have not been able to broach. That said, this situation is starting to change this fall, with two U.S. firms entering both Greece and Denmark, but in general, a big issue. Canadian firms are still trying to figure out how to both utilize the public markets in the U.S. without getting caught in detention when crossing the border.the U.S. is continuing to be a popular place to go public for Canadian firms
Regardless, the U.S. is continuing to be a popular place to go public for Canadian firms, who are also looking for access to global capital markets and institutional capital. Right now, Frankfurt is off limits for many of them. See the Deutsche Börse. That said, with the rules already changing in Luxembourg, one firm has already set its sights for going public in Frankfurt next spring.
The German Situation
Like it or not, the situation in Germany is key to the entire EU and increasingly a global enchilada, and no matter where companies are basing their cultivation sites at this point, there are two big gems in the European cannabis crown. Deutschland is the first one because of the size of the economy, the intact nature of public healthcare and the fact that the German government decided to mandate that sick people could get medical cannabis reimbursed by their public health insurer.
Ironies abound, however. In the last quarter, it is clear from the actions of the Deutsche Börse that Frankfurt is not a popular place to go public (Aurora went public on the NYSE instead in late October).
The cultivation bid was supposed to come due, but it is now likely that even the December deadline might get pushed back again, interminably at least until April when the most recent lawsuit against the entire process is due to be argued.
In the meantime, there is a lot of activity in the German market even if it does not make the news. Distribution licenses are being granted all over the country (skip Berlin as there are already too many pending). And established distributors themselves, particularly specialty distributors, are increasingly finding themselves the target of foreign buyout inquiries.
There are also increasing rumours that the German government may change its import rules to allow firms outside of Canada and Holland to import into the country.
The German market, in other words, continues to cook, but most of it is under the surface a year and a half after legalization, to figure things out.
Next to October 17, the other date of note this fall of course was November 1. The Limeys may not have figured out Brexit (yet). But cannabis for medical use somehow made it through the national political fray this summer. Hospitalized children are compelling.
Now the question is how do other patients obtain the same? The NHS is in dire straits. Patients must still find a way to import the drug (and pay for it). And with newly imposed ex-im complications coming Britain’s way soon, there is a big question as to where and how exactly, patients are supposed to import (and from where). All looming and unanswered questions at the moment.
But hey, British doctors can now write prescriptions for cannabis.
Greece and Malta
Greece and Malta are both making waves across Europe right now. Why?
The licensing process that has continued into the fall is clearly opening up inexpensive cultivation in interesting places. Greece is growing. Malta, an island nation that is strategically placed to rival Greece for Mediterranean exports across Europe is still formalizing the licensing process, but don’t expect that to last for long.
Look for some smart so and so to figure out how to beat Brexit and import from Malta through Ireland. It’s coming. And odds are, it’s going to be Malta, if not the Isle of Mann that is going to clinch this intriguing if not historical cultivation and trade route.
Just as October came to a close, the Polish government announced the beginning of medical imports. Aurora, which went public the same week in New York, also announced its first shipment to the country – to a hospital complex.
Let the ex-im and distribution games begin!
It is widely expected that the Polish market will follow in German footsteps. Including putting its cannabis cultivation bid online whenever the Polish government decides to cultivate medical supplies domestically. The country just finalized its online tender bid system in general.
Does anyone know the expression for “pending cannabis bid lawsuit in Warsaw” in Polish?
While it gets little press outside the country, the Danish four year experiment is reaching the end of its first year. While this market was first pioneered by Canopy/Spectrum, it was rapidly followed by both Canadian LPs and others entering the market. Latest entrant this quarter? A tantalizingly American-British conglomerate called Indiva Ltd. as of November 21.
Italy is also starting to establish a presence in interesting ways as multiple firms begin to establish cultivation there.
There are also increasing rumours and reports that Israel might finally be able to start exporting next year. That will also disrupt the current ecosystem.
And most of all, beyond a country-by-country advance, the World Health Organization meeting in early November and in the early part of December is likely to keep the pressure on at a global level for rescheduling and descheduling the cannabis plant.
This in turn, is likely to set the stage as well as the timeline for rec use in Luxembourg. Look for developments soon.
A busy time indeed. Not to mention a quarter to end a very intriguing year, and certainly destined to sow returns for years to come, globally.
On Election Night in America, pundits on the news media were reporting on the blue wave of Democrats taking back control of the House of Representatives, a less-discussed green wave made its way through the ballots in a number of states. While not as big of a tidal force as we saw back in 2016, this election still brought a handful of states on the cannabis legalization train.
Measure 3 in North Dakota failed to get enough votes, but many seem to think this was somewhat expected, as the state is still working on implementing their medical framework years later and that this new measure was less than perfect.
However, here comes the good news: Missouri voters passed Amendment 2, which legalizes, regulates and taxes medical cannabis. Very interestingly, this measure includes language allowing for caregivers to grow up to six plants. Check out Tom Angell’s article on Forbes to learn more.
In Utah, Proposition 2 passed by a narrower margin than other states, but legislators in the state are already full steam ahead on legalizing medical cannabis. They planned to pass a bill with the same language in Prop 2 if it didn’t get enough votes. Regardless, Utah will begin working on implementing a regulatory framework for legal medical cannabis, per the voters’ request.
While the 2016 election saw a handful of states legalize recreational cannabis, only one state did so this time around: Michigan. Voters in Michigan passed Proposal 1, making it the ninth state in the country to legalize and regulate recreational cannabis. According to Matthew Schweich, deputy director of the Marijuana Policy Project, Michigan’s legalization is a major milestone for the country. “The passage of Proposal 1 is a major milestone for marijuana policy reform in the U.S. Michigan will be the first state in the Midwest to end marijuana prohibition and replace it with a system in which marijuana is regulated for adult use,” says Schweich. “Michigan is going to demonstrate that regulating marijuana works, and it will set a strong example for other states in the region and around the country.”
Update: On September 21, 2016, Governor Rick Snyder signed the bills into law, regulating the market officially.
The Michigan House of Representatives voted in concurrence with last week’s Senate vote, approving a series of bills that would establish a regulatory framework for the state’s medical cannabis industry, according to a Michigan Live article. Governor Rick Snyder is expected to sign the bills into law very soon.
The package of bills approved today includes provisions for a 3% tax on retail income, a licensing system for growers, dispensaries and patients as well as establishing a traceability system. The bills, if signed into law, would institute a regulatory framework akin to other states that have legalized cannabis recently. Packaging, labeling and testing requirements for THC, other cannabinoids and contaminants are included in the overhaul.
In 2008, voters approved the legalization of medical cannabis, since then however there has been little action from the state on regulating the safety, sale or distribution of cannabis. The bills are meant to eliminate the previous ambiguity in the laws surrounding the state’s patients, caregivers and dispensaries and establish a legitimate system for patients to access medical cannabis.
According to Stephen Goldner, founder of Pinnacle Laboratories in Michigan, the market will get regulated into five discrete categories for licensing: growers, dispensaries, testing labs, processors, and transporters. “The basic legislation that will become law is very sensible and almost completely mirrors what has already been passed by the Michigan House, thus rapid conformance is nearly guarantied,” says Goldner. “There is a clear intent to require all products to be tested before sale, and setting up an integrated reporting system by product batch code from production, through transport and to final sale.” Goldner believes this comes with an overriding intent to establish standardization across the board, and points to the Foundation of Cannabis Unified Standards (FOCUS) for ready-to-implement, vetted standards.
“Michigan requiring method validation and other requirements, such as adverse event reporting, thereby builds in greater assurance of product safety and compliance,” says Goldner. Pinnacle Labs has been preparing for this day for quite some time. “We have invested the past 18 months preparing for exactly this legislation,” says Goldner. “We look forward to helping the medical cannabis patients in Michigan get cost-effective, desirable products delivered legally and easily.”
If passed, this kind of legislation will present a litany of challenges for the state and all stakeholders involved. Growers dealing with contamination issues previously will now have to navigate legally mandated testing requirements. According to Goldner, the greatest challenges are those that other states already deal with. “The greatest challenge for dispensaries and other business in the chain of distribution is the lack of adequate banking services,” says Goldner. The state will have to hire inspectors, establish robust oversight and review applications while maintaining a smooth transition to a regulated market.
Until Gov. Snyder signs them into law, the state’s cannabis industry and the 203,000 patients remain in a state of uncertainty.
We have not seen food processing opportunities in the 45 years I’ve been in the industry like we are seeing in the cannabis food segment. There are still many legal, regulatory and policy misconceptions and this column is devoted to giving you some clarity. I hope this helps you make sensible business plans based on sound marketing opportunities.
It’s hard for many people to make the leap from thinking marijuana is illegal to knowing that food infused with marijuana is legal in 50% of the US, and quickly moving toward national legality. Any food processor that does not consider this opportunity to meet changing market dynamics risks losing a huge opportunity.
23 states, the District of Columbia and Guam now have comprehensive cannabis programs in place and many more are expected through Q4 of 2016. The voter approval, tax aspects and improved law enforcement profiles are highly favorable towards legalization and regulation. While marijuana itself can’t be shipped across state lines legally at this time, food-processing equipment is being sold, shipped, and installed every day of the week with no legal ramifications. The remaining problematic business aspects are rapidly moving through the solution phase, specifically labeling, tamper-evident and child resistant packaging, and payment methods.
Unlike other technology introductions, a mass market already exists and is clamoring for these food products. Therefore the ‘early movers’ are developing business relationships state by state to prepare food production lines that incorporate cannabis food production into cannabis processing companies.
Essentially, any state that allows cannabis dispensaries to exist will require food-processing equipment. In addition, states like Michigan where I reside, there are over 200,000 medical marijuana licenses issued to individuals, and over 250 unlicensed dispensaries. Michigan is getting ready for dispensary licensing and food production. We should anticipate inquiries from companies applying for food production licenses from any and all states as they are carefully attuned to their local state rules.
Jurisdictions with active cannabis food production in USA: Arizona, California, Colorado, Connecticut, Delaware, Washington, D.C, Guam, Illinois, Maine, Maryland, Massachusetts, Michigan [coming soon], Minnesota, New Hampshire, New Jersey, New Mexico, New York, Rhode Island, Vermont, Washington
The next few articles in this series will focus on making certain your food production equipment will meet cannabis food production regulatory standards, the unusual payment procedures in this new industry, and relationship building since many of the new companies and their advisors will be new to you. Plus you really want to know their expectations of you.
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