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Lezli Engelking

Q&A with Lezli Engelking: Why Are Standards Important?

By Aaron G. Biros, Lezli Engelking
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Lezli Engelking
Lezli Engelking
Lezli Engelking, founder of FOCUS

FOCUSlogoLezli Engelking founded the Foundation of Cannabis Unified Standards (FOCUS) in 2014 to protect public health, consumer safety, and safeguard the environment by promoting integrity in the cannabis industry through the use of standards. Standards are an agreed upon way of doing things and specify guidelines or requirements for producing goods or providing services, according to FOCUS.

Peter Maguire, committee chair of the FOCUS Cultivation Standard
Peter Maguire, committee chair of the FOCUS Cultivation Standard

Standards can take the form of a “reference document, which may include specifications, guidelines, conditions or requirements for products, operations, services, methods, personnel and systems on how to design, operate, manufacture or manage something.” Peter Maguire, VP of System Applications for Lighthouse Worldwide Solutions and committee chair of the FOCUS Cultivation standard, joined the organization wanting to make a positive impact on the industry that is in line with protecting people and medical patients. He sees so much variability in the industry and the need to homogenize standard operating procedures (SOPs). “I have worked with multiple cultivation facilities and a few of them have operating procedures in place but having them in place is only half the solution- it’s critical to have the right ones in place,” says Maguire. He has twenty years of experience in contamination control in manufacturing, before entering the cannabis industry.

The FOCUS cultivation standard was created by experts who have years of experience in both cannabis cultivation, good agricultural practices and in the tightly regulated pharmaceutical industry. “FOCUS created these guidelines as a sort of roadmap for success in business; You need to keep your employees healthy and your products safe to survive in the long term,” says Maguire. We sit down with Lezli Engelking to find out how the standards are created, what makes them significant and what businesses can gain by working with them.

CannabisIndustryJournal: Why are standards important?

Lezli: Standards are the international language for trade – they exist in every industry. “The U.S. Department of Commerce estimates that standards and conformity assessment impact more than 80% of global commodity trade.” FOCUS is not reinventing the wheel with what we are doing. We are simply adapting a business model the federal government already uses. In the 80s, when the heroin epidemic swept across the US, methadone clinics popped up in every state in the country within two years. The clinics were all operating under different state, city and county regulations – much like the cannabis industry is today. The federal government took a look at the situation and decided they needed a way to regulate these clinics in order to protect public health and safety. They released a Request For Proposal (RFP) looking for an organization to create voluntary-consensus standards and a third-party certification system for the methadone clinics. Commission on Accreditation of Rehabilitation Facilities (CARF) is the organization that answered and won that RFP. CARF continues to work with Health and Human Services to maintain the standards and provide third-party certification to the clinics today. FOCUS develops international, voluntary consensus standards and a third party certification program for the global cannabis industry based on the CARF model. This is extremely important, because of the National Technology Transfer and Advancement Act, (Public Law 104-115), signed into law March 7, 1996 by President Clinton. The act requires that all federal agencies use standards developed by voluntary-consensus standards bodies, instead of government-unique standards wherever possible. Perhaps even more importantly, the Act includes provisions that encourage federal agencies to partner with the private sector in the development of standards that not only help improve the efficiency and effectiveness of government, but also strengthen the U.S. position in the global marketplace.

CIJ: What exactly goes into developing a voluntary-consensus standard?

Lezli: Voluntary-Consensus refers to the type of standard and how it is developed. Everyone who participates in the development of voluntary-consensus standards does so on a voluntary basis. Committee members must come to a consensus on every point within the standard- down to every comma or semicolon. Once the development process is complete, the standards must undergo a 30-day public review period. The process for developing voluntary-consensus standards is designated by International Organization for Standardization (ISO). ISO has member agencies in 163 countries that participate in the development of standards. The American National Standards Institute (ANSI) is the American body for ISO. FOCUS follows all ISO/ANSI guidelines in the standards development process. This is extremely important because it means FOCUS standards are suitable for accreditation and adoption into regulations according to the National Technology Transfer and Advancement Act. All voluntary-consensus standards are developed under the principles of:

  • Openness| Participation in the standard development process is open to individuals with a stake in the standard who bring useful expertise along with the spirit and willingness to participate.
  • Balance| Focus stakeholder groups involve all stakeholder groups: industry, regulatory, quality assurance, medical, law enforcement, business, research, consumers, patients and the general public.
  • Voluntary-Consensus| Individual subcommittees of volunteers develop each area of the standard, offering their unique expertise to form a consensus. They are not paid for their participation.
  • Lack of Dominance| No party has dominant representation, or influence to the exclusion of fair and equitable consideration of other viewpoints.

CIJ: More specifically, how are the FOCUS standards developed?

Lezli: To create a baseline standard, FOCUS utilized World Health Organization (WHO) guidelines for Good Manufacturing Practices (GMP), Good Agricultural Practices (GAP), Good Laboratory Practices (GLP), Code of Federal Regulations (CFR) for pharmaceutical GMPs, nutraceutical GMPs, food safety standards, OSHA and HACCP. From there, applicable cannabis regulations from around the world were added. All of this information was compiled into auditor-style checklists. Each committee member was provided time to go edit, remove or add to items in the checklist on their own. Over the next two years, each of the eight committees had monthly meetings, going through and coming to a consensus on each line item of the standard. Once the committees completed development, the standards were open for a 30-day Public Review to collect comments and feedback. The first eight FOCUS standards, completed and ready for use, cover Cultivation, Retail, Extraction, Infused Products, Laboratory, Security, Sustainability and Packaging & Labeling.

FOCUS is currently recruiting committee members to begin development of five new cannabis standards later this year: Advertising/Marketing, Insurance, Banking/Finance, Patient Care and Research. Committees will receive a list of proposed suggestions for what should be considered in developing the standards. Each committee member will develop a list to select criteria they think should be included into the standard. FOCUS will compile the lists, then committees will go through the monthly standards development/vetting process for each line item in the standard.

CIJ: So what does a business have to gain by adopting a FOCUS standard?

Lezli: Compliance becomes easily manageable with the FOCUS software platform, integrating standards, training and SOPs into the everyday operations of the business. FOCUS certified clients could expect to reduce costs, reduce risk and reduce liability by assuring they are producing safe, quality and consistent products. FOCUS certification allows a business to differentiate themselves from their competitors, and prove to their patients and customers they can trust their products. Certification also allows businesses to access reasonable insurance rates and drives interest from investors.

FOCUS is here to partner with cannabis businesses. We are there to hold their hand, by providing guidance and assistance along every step of the way. Unlike state mandated audits that delineate what a business is doing right or wrong, FOCUS is an on-going compliance management system. We are here to make sure a business runs as efficiently as possible and take the guesswork out of compliance. Under FOCUS certification, a business receives ongoing consulting, customized SOPs, employee training and a documentation management software system to track and prove compliance.

CIJ: Can you give us an update on FOCUS’ progress in 2016?

Lezli: A large milestone for FOCUS this year, aside from completing version one of the standards, is choosing an appropriate software platform, (Power DMS) to house the standards and provide an ongoing compliance management system for our clients. Power DMS also houses regulatory standards for law enforcement; health care, federal aviation and fire departments, so most agencies in public health are already familiar with it. The familiarity and access to this platform is a huge benefit on the regulatory side. It allows first responders to access the schematics of a FOCUS certified client in the event of an emergency. This is crucial in the event of an explosion from extraction equipment, or a fire in a cultivation facility, as without first identifying where the hazards are, they will not access the facility. The FOCUS software platform allows first responders access to all pertinent information through computers in police cars, ambulances, or fire trucks.

For the industry, the FOCUS software platform is equally as impressive. Not only does the platform house the standards and all SOPs, it is also complete compliance management system. FOCUS certified clients have a simple management tool that houses all training and documentation, assuring all required compliance documentation can be easily accessed at any time. The platform also allows FOCUS certified clients to provide access to governing bodies in advance of state audits –streamlining the process and minimizing time and interruption caused by state audits. The FOCUS platform tracks all changes to required documents, provides real time updates on employee training, creates appropriate traceability logs, and provides updates on regulatory changes, including which SOPs need to be changed to maintain compliance. The platform allows FOCUS to be way more than an auditing company. FOCUS is a partnership in compliance for cannabis companies wanting to maintain good business practices and stay compliant with regulations.

We have about 140 new committee members that will assist existing committees with standards updates and participate in the development of the next set of FOCUS standards for advertising/marketing, banking/finance, research, patient care and insurance. All committees will convene before 2017.

Oregon October 1st Compliance Deadline: What You Need to Know

By Aaron G. Biros
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Oregon cannabis regulators began enforcing new rules over the weekend when the October 1st compliance deadline passed. Compared to the relatively cut-and-dried new Colorado regulations, the Oregon cannabis market faces more complex and changing regulatory compliance issues.

The new rules in Oregon address changes to testing, packaging and labeling regulations along with concentration and serving size limits, according to a bulletin published by the Oregon Health Authority (OHA) and the Oregon Medical Marijuana Program (OMMP) earlier this week. Most of the new rules are meant to add safeguards for public health and consumer safety, while putting an emphasis on keeping cannabis away from children.oha_logo_lrg

Around the same time, the Oregon Liquor Control Commission (OLCC) published a bulletin with a new temporary rule that is meant to prevent marketing to children. The OLCC’s temporary rule clarifies “restrictions on product wording commonly associated with products marketed by or to children.” The OLCC reviewed around 500 strain names and found roughly 20 of them that could appeal to children. The OLCC will not approve labels that include strain names like Girl Scout Cookies, Candyland and Charlotte’s Web, among others. This means that breeders and growers have to change strain names on labels like Death Star, Skywalker and Jedi Kush because they contain a reference to the Star Wars franchise, which is marketed to children.

Oregon Marijuana Universal Symbol for Printing
Oregon Marijuana Universal Symbol for Printing

The new testing regulations establish requirements for testing cannabis products for THC and CBD concentrations, water activity, moisture content, pesticides and solvents in concentrates. They also stipulate that ORELAP-accredited laboratories must perform the testing. In the time leading up to the compliance deadline, many lacked confidence that ORELAP would accredit enough laboratories to meet the demand for testing. “We have heard from existing accredited labs that they can meet demand for cannabis product testing,” says Jonathan Modie, spokesman for the OHA. “We don’t yet know how much product requires testing, so we can’t speculate on whether labs will indeed be able to meet demand.” It is still unclear at this time if there are enough laboratories to perform all of the testing for cannabis products in the state.

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The universal symbol on a label of a cannabis product purchased after Oct. 1

At this time, 16 laboratories have been accredited for some form of testing, but only four labs have been accredited for pesticide testing. A list of the labs that ORELAP has accredited can be found here. Notably, only one lab is accredited for testing microbiological contaminants, such as E. coli. Testing for microbiological contaminants is not required for all cannabis products sold, rather it is only required upon written request by the OHA or OLCC.

The new labeling and packaging requirements concern testing, consumer education, childproofing and preventing marketing to minors. All cannabis products must contain a label that has been pre-approved by the OLCC. “Cannabis products have to be clearly labeled, showing that is has been tested, or if it has not been tested then it must display ‘does not meet new testing requirements’,” says Modie. “It [the label] must be clear, legible and readable, so they [the consumer] know exactly what it contains, including what cannabis product is inside the package, how much of it, how much THC, and where the product came from.”

According to Modie, it is particularly important that the packaging is not attractive to minors. Cartoons, designs and names that resemble non-cannabis products intended for, or marketed to children, should not be on the packaging or label. “Part of our education to the public and recreational cannabis users focuses on keeping these products out of reach of children in the first place, like storing cannabis in a locked area or an area where a child cannot reach or see,” says Modie. “Our goal is always to protect public health.”

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Sustainability for the Cannabis Industry: Part I

By Olivia L. Dubreuil, Esq., Brett Giddings
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The cannabis industry is an unusual creature. It is so new and fluid that nothing in its space is yet crystallized. Product types, brand names, generally accepted processes and procedures are all still being invented and tested. Consumer market segments are defining themselves as the progression of legalization advances through the states. Seniors, children, veterans, women, and professionals of all backgrounds are feeling the health and wellness benefits of the flower that is slowly losing the negative stigma inherited from the so-called war on drugs. The potential is enormous. Money is already flooding to the lucky entrepreneurs with enough foresight to work in the space, and corporate business leaders from many other traditional sectors are slowly, but steadily flocking to the market.

This is economically encouraging. A whole new industry that creates new jobs, generates tax revenue and creates wealth. But there is a worrying scenario. In that scenario, traditional cannabis business owners and entrepreneurs are pushed out of the market as corporate competitors enter the game. In that scenario the industry grows faster than its regulatory framework, with little to no voluntary regulations, no sustainability leadership, and the industry’s practices and reputation finish in the gutter. In that scenario, federal and state regulators ramp up indiscriminate bans and phony prohibitions. In that scenario the new cannabis industry exacerbates the world’s social and environmental problems by being non-inclusive, by creating a divide within communities, by adding its own share of pollution, by pushing unhealthy and unsafe products – all for the sake of an easy buck.

That scenario is not a certainty – it does not have to see the light of day. This industry has the potential to be different. It has the unique opportunity to integrate sustainability practices from the start, to create a space where business meets mindfulness, and where corporate profits do not trump consumer health, worker welfare, community engagement or environmental preservation.

Sustainability strategy is the best risk management tool available to the cannabis businesses emerging today that hope to stay relevant in the future. A sustainable cannabis industry is one where women and minorities feel included, where the consumer recognizes and is loyal to brands and labels, where businesses are thriving while having a positive influence on their peers, a positive impact on their community and on the environment, where the race to the top breeds best practices and innovation.

Three levers can push sustainability: the consumer, the industry (and the businesses that comprise it) and the government (local, regional, national and international). Surprisingly, businesses can have a significant influence on all three. Consumers make and shape a market. What will happen when the consumer becomes aware of fossil-fuel (benzene) extraction in the age of climate change, when they request organic flowers that fits their ‘Wholefoods lifestyle’, or when they boycott non-biodegradable packaging? What will happen when a scandal breaks, linked to an avoidable health and safety accident, or when they realize people of color do not have equal opportunity in a cannabis business?

It is preposterous to think, that in this day and age – where information travels at the speed of light, some type of potentially damaging information about a product manufacturing process will not get out at some point or another (in some cases they have). There is absolutely no need to gamble with that. The solution is simple: adopt sustainable practices from the start.

The third lever is the government – we will come back to the second lever later. The cannabis industry, better than any other industry, knows how the government can make or break a business. If the government decides, like they did in Colorado, that in nine months cannabis packaging needs to be resealable and childproof, businesses will have to sit on several weeks worth of sales until they can find new suppliers, they will probably have to rethink their processes, while absorbing the costs of the packaging they had bought in advance. Worse case, they also have marketing and merchandising to rethink. All of that is costly.

However there is good news; government can be channeled, generally speaking, by doing the right thing. If an industry actively demonstrates a desire to do the right thing, and there is not an exaggerated amount of complaints (or accidents), then regulators will leave it alone. Businesses can and should invest as a group into drafting and endorsing generally accepted industry practices and organizing industry self-regulations. Those will guide governments when they draft regulations, but they could also preempt a lot of nonsensical top down rules

The second lever is the most important, and that is the business lever. Cannabis businesses can make or break this industry. Those who believe that the unsustainable practices that worked in the context of an illegal/black/grey market will work in the context of a 21st century legal industry may need a reality check. Those who continue to promote and endorse them are dangerous for the industry because they breed a climate of distrust, and they bring the industry under closer scrutiny. The cannabis industry needs businesses that display exemplary behaviors, think about their impact, and elevate the discussion as well as their peers.

Whether a business is small, large, mature or emerging, developing a strategic response to these challenges can and will create a sustainable business model. Businesses can gain robust competitive advantages over their peers, reap the rewards of having loyal customers, create thriving communities, and foster healthy natural environments by doing the right thing and embedding sustainability within their business decisions.

Tomorrow’s cannabis industry business leaders will be those that chose to be part of the solution, those that understood that sustainability was vital to their business model and took action early on.logo name1


Editor’s Note: Project Polaris is a California non-profit corporation, offering sustainability coaching and guidance to cannabis industry businesses. By becoming a member of Project Polaris, businesses have access to sustainability experts throughout the year, to set, support and carry out cost-effective, meaningful and impactful sustainability solutions.

good to know kit

Colorado Distributes Consumer Education ‘Good To Know’ Kits

By Aaron G. Biros
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good to know kit

The Colorado Department of Public Health and Environment (CDPHE) launched the Good to Know program in January of 2015, aimed at educating the public on consuming cannabis responsibly. The CDPHE developed a free kit for retailers that will be distributed this week, hoping to reinforce safe and responsible experiences with cannabis at the consumer level. Intended specifically for recreational cannabis retailers, the educational materials will be distributed at the point of sale.

good to know kit
The Good to Know kit for retailers

According to the CDPHE, last year between April and August, Colorado saw a 28 percent increase in retail cannabis sales. In anticipation of a period of high demand this summer, the ‘Good to Know’ retailer kits are being distributed this week. According to Ali Maffey, CDPHE policy and communication unit supervisor, the state is mailing 100 kits to additional retailers ahead of cannabis-related events, such as April 20th, which are expected to bring an influx of tourists.

The takeaway information cards in the kits display frequently asked questions regarding edibles and secondhand smoke, as well as advice for appropriate legal usage of cannabis. “The educational materials can help guide bud tenders through a conversation with a consumer to prepare them for the effects of cannabis, dosage considerations, using caution with edibles, driving impairment and the risks of second hand smoke,” says Maffey. “Voters passed the legalization of cannabis, and as the state health department our role is to educate on the safe and responsible use of cannabis, while safeguarding public health.”

The continued efforts by the state for consumer education could highlight an important push for safety. “We have been talking with other states about what works in our messaging and they are all looking at public education campaigns as well,” says Maffey. In this respect, Colorado is leading the country in educating consumers on safe, responsible and legal cannabis use.

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Biros' Blog

The Cannabis Industry’s Pesticide Problem

By Aaron G. Biros
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Colorado regulators recalled roughly 65 batches of cannabis produced by two separate companies last Friday. Pesticide recalls plastered all over the news in the past few months have painted a picture of the cannabis marketplace to the public as unsafe and lacking crucial quality standards. The continued pesticide recalls in Colorado, along with poor safety standards in Washington, show the cannabis industry in an unfavorable light. The recalls include not only cannabis sold recreationally, but also medical cannabis, which should highlight a sense of urgency to deal with such a pervasive issue.

Because patients with weakened immune systems are seeking treatment with cannabis, it is the producer’s obligation to grow cannabis safely and without pesticides. That requires proper quality controls, pesticide use standard operating procedures, very robust lab testing and an overall push to protect consumer safety from both regulators and industry leaders.

The pesticides most commonly found in cannabis products include myclobutanil, a fungicide in Eagle 20, and avermectin, commonly found in Avid pesticides. The Pesticide Action Network lists both compounds as “bad actors” and as developmental or reproductive toxins.

Largely due to federal illegality, there are no EPA-approved pesticides for use in cannabis production, thus a lack of guidelines for states to follow in regulating pesticide use. As a result, states are working to write their own lists of approved pesticides.

Until very recently, Washington had no procedure for recalls of cannabis in place. “The LCB in Washington State has implemented emergency recall rules but more clarity on what types of pesticides are harmful is needed,” says Trek Hollnagel, co-founder of Dope Magazine and a chain of dispensaries in Seattle, WA. It is no secret that the Washington State Liquor Cannabis Board (LCB) poorly regulates cannabis labs.

Reports show immense variation in different labs’ results and rampant laboratory shopping. Dana Luce, co-founder of GOAT Labs, Inc., a cannabis-testing laboratory based in Vancouver, Washington, has been clamoring for a standardized recall procedure. “The state needs to take a much more proactive approach in monitoring laboratories,” says Luce. “Using blind testing or secret shoppers would give them the opportunity to catching those labs playing below board.” Luce also believes that retail outlets should absorb the cost of recalls, which could help prevent laboratory shopping just for higher potency test results.

In Washington, regulators rely on producers to self-report coupled with random inspections; furthermore they do not even require pesticide testing. Without a burden of proof placed on the producer or even the laboratory, it is hardly a regulated market.

Those producing cannabis with pesticides listed above should know they are violating the law. According to Comprehensive Cannabis Consulting (3C), “applying pesticides off label is a violation of state and federal law and could result in criminal and civil sanctions…”

In reality, the solution to this problem is not just a quick fix, but a multitude of corrective actions to move the cannabis industry forward. Nic Easley, chief executive officer of 3C, believes it starts with educating cultivators on using pesticides properly and good agricultural practices (GAP). “Many of the pest problems prompting the illegal use of pesticides are due to poor facility design, lack of cleanliness, over-fertilization and other general plant health issues,” says Easley. “All of those issues could be greatly reduced through education in GAP.”

Then comes regulator-industry collaboration, where all parties are constantly learning. “Regulators or independent third-party groups need to be performing on-site inspections, which cultivators need to participate in openly and transparently,” adds Easley. The Colorado Department of Agriculture (CDA) is actively working on this aspect by offering workshops aimed at helping producers get up to speed with worker protection standards.

“Adequate standards need to be applied across the board to labs, and ongoing proficiency testing needs to take place to ensure that a lab’s facility, processes and instruments are fully validated,” says Easley. So the problem is cannabis producers still using pesticides off label and if that continues, so will the recalls. It seems the solution involves industry-regulator collaboration, more robust laboratory systems and calibration methods and educating cultivators on good agricultural practices. Additionally, more state guidance is needed in the form of research for an approved list of pesticides on cannabis and a bigger push for regulation in the form of inspections and laboratory oversight.

Are You Ready For an Inspection?

By Maureen McNamara, Lezli Engelking
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Would you be proud to have your customers and patients tour your production facility? When health inspectors or enforcement personnel arrive at your location is there sense of panic or pride?

When you have detailed systems in place, inspections should be informative, not stressful. Keep in mind that in the cannabis industry, products are often created for patients. Patients may have a compromised immune system and thus are more susceptible to food borne illnesses, pesticides and other contaminants.

Are you and your team doing everything you can to produce a wholesome and safe product?

According to the World Health Organization, Good Manufacturing Process (GMP) “is a system for ensuring that products are consistently produced according to quality standards.”

GMP is the proactive part of quality assurance. It is designed to minimize the risks involved in all steps of the manufacturing process. A basic tenant of GMP is that quality cannot be tested into a product. It must be built into each batch of product during all stages of the manufacturing process.

GMPs involve much more than most people think. A common misconception is that GMP only covers the process of manufacturing itself. GMPs actually cover all aspects of the production process:

  • Materials
  • Premises
  • Equipment
  • Storage
  • Record Keeping
  • Staff Training to Hygiene
  • How Complaints Are Handled

GMP & The Cannabis Industry

In most industries, agencies that control licensing for the manufacture and sale of a product recommend GMPs, or guidelines to business owners. These guidelines provide minimum requirements that a manufacturer must meet to assure that products are of high quality and do not pose any risk to the consumer or public. The guidelines generally become the basis of regulation for that industry.

In the United States, the Food and Drug Administration (FDA) recommends guidelines for anything food, drug or pharmaceutical related.

Because cannabis still remains illegal at the federal level, none of the federal agencies that would normally develop good manufacturing guidelines have done so. This has left state lawmakers and business owners on their own to navigate this new and rapidly developing industry.

The Foundation of Cannabis Unified Standards (FOCUS) has developed standards with a mission to protect public health, consumer safety and safeguard the environment by promoting integrity in the cannabis industry.

The comprehensive implementation of cannabis specific good manufacturing practices, like the FOCUS standards, across all aspects of the industry will assist business owners and regulators alike, addressing quality proactively at every step in the process, which is critical to protecting consumer safety and public health – and the overall success of a nascent and divisive industry like cannabis.

The FOCUS standards are completing the final phase of development, a thirty-day public review and comment period before being released for use in the marketplace in June. These voluntary consensus-based standards are built on GMPs drawn from agriculture, food production, chemical management, OTCs, pharmaceuticals, and other relevant industries. In addition, the standards draw best practices from the cannabis industry, as well as those published in OSHA, FDA, FTC, CDC, ISO, code of federal regulations and various state-level cannabis regulations.

There are many aspects of creating and implementing GMPs. Here are three to be aware of:

  1. Get the facility design right from the start: It’s much easier to be GMP compliant if the design and construction of the facilities and equipment are right from the start. It is important to embody GMP principles and use GMPs to drive every decision. 
  1. Document what you do and do what you document: Having good procedures in place to ensure a controlled and consistent performance is an essential part of GMP. Procedures should be clear, concise, logical, and available to everyone.
  1. Keep good records: Keeping accurate records is an essential part of GMP. It helps convey that you are following procedures and demonstrates that processes are known and under control. If it’s not written down, it did not happen.

Standards and quality programs in any industry are dynamic by nature. Nothing is static. Standards must constantly be updated to reflect ever-changing market conditions. This is why it is so crucial that regulations are based on them.

To be a standard, there are certain core principals that must be present. However, the goal of a standard is to guide an industry without impeding or controlling it. This is why there is so much inherent value in implementing standards. They bring enough structure to help reduce costs and increase efficiency, but not so much control that individual nuances or creativity is affected.

It is much less expensive to be proactive. Recovering from a recall or contaminated product can not only be costly, it is a massive hit to the company’s reputation. It may take years for sales to recover, and for consumers to trust the product again. Where could you and your team enhance your standards and processes?

OGanalytical instruments.

New Cannabis Lab Rules In Oregon Aim to Curb Fraud

By Aaron G. Biros
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OGanalytical instruments.

The Oregon Health Authority (OHA) recently implemented a set of temporary rules effective through June 28th of this year with the goal to establish a set of regulations for cannabis testing by October 1st. An investigation by The Oregonian highlighted some of the previous problems with cannabis testing in the state.

The most impactful rule changes include The NELAC Institute (TNI) mandatory standards for laboratories that the Oregon Environmental Laboratory Accreditation Program (ORELAP) will use to accredit labs. Initial rules in the Oregon medical cannabis program, HB 3460 from 2013, did not specify accreditation rules for cannabis testing.

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The OG Analytical laboratory in Eugene, Oregon is working to comply with new regulations, including new sample collection rules

ORELAP currently performs accreditation for lab testing under the Clean Air Act, Clean Water Act, Resource Conservation and Recovery Act and the Safe Drinking Water Act. The new cannabis testing rules will give ORELAP the authority to accredit and regulate cannabis labs in the state of Oregon.

Rodger Voelker, Ph.D., laboratory director of OG Analytical in Eugene, OR, believes these rules are monumental in establishing legitimacy in cannabis testing. “These new rules have major repercussions mainly because they require not only getting accreditation, but maintaining it with very strict requirements,” says Voelker. “That also includes procedural guidelines that very carefully outline the quality of laboratory practices and establishes a set of criteria for method validation.”

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Rodger Voelker, lab director at OG Analytical laboratory

Voelker notes that two of the biggest changes are in quality control and data management. “The documentation they require is very thorough and strict with the idea that any aspect of an analysis can be replicated,” adds Voelker. “This is a real win for us in my opinion because now we have an agency that can issue the appropriate credentials as well as have the authority to make punitive measures.”

The timeline for implementation with temporary rules allows state regulators to work with laboratories to perform accreditation and bring laboratories up to speed. According to Shannon Swantek, ORELAP compliance specialist, products that dispensaries sell in medical and recreational markets are required to be tested under the new rules and in the analyte lists by an ORELAP accredited laboratory, starting on October 1st.

Swantek’s job is to accredit cannabis labs to the TNI standards, which is essentially very similar to ISO 17025, just with more prescriptive measures and the ability to pair with state agencies to enforce rules after accreditation. “The timeline for accreditation is dependent on how ready the lab is and how compliant they are to the TNI standard already,” says Swantek. “The culture had gotten so fraudulent that the legislature felt Oregon needed some serious, more strict rules in place.”

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Labs need very expensive instruments to perform all of the testing required by OHA

One of the biggest changes coming to Oregon cannabis testing is the new sampling requirement. “An accredited laboratory employee must take the sample because sampling is where a lack of training or outright fraud is skewing results, which occurs when a grower brings in a sample not representative of the batch,” adds Swantek. Sample preparation methods will also be required to be more robust to meet the action limits of pesticide testing in particular, helping to identify lower levels like parts-per-billion, according to Swantek.

Reports were also lacking key information in the past. The new rules will require more information such as the procedure used, the analyst carrying it out, dilution factors and any other information you need to theoretically reproduce the result. This will result in more accurate labels on products.

Many are concerned that the new lab testing requirements will raise the price of testing too much. In reality, those current prices are not realistic for accurate data, which points to the rampant fraud that ORELAP is trying to eradicate. “The old rules were written in such an ambiguous way that the prices were set by laboratories without a proper quality program or even without proper instrumentation,” says Swantek.

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OG Analytical had to close its doors briefly to meet accreditation

The accreditation process will require particularly robust quality control systems in labs. “Accreditation to the TNI Standard means that lab quality systems will require a documentation system, training procedures, record keeping, personnel requirements, organization details, proof of no conflicts of interest and corrective actions if noncompliant,” adds Swantek. “We single out each method or procedure, look at their raw data and proficiency testing and determine if they are meeting the technical requirements.”

According to Voelker, other industries have learned to adjust their costs with stringent lab testing rules. “I get that no one wants to pay more for lab testing, but the reality is that joining the world of commodities comes with additional costs to ensure consumer safety,” says Voelker. These rule changes will undoubtedly bring more consistency to Oregon’s cannabis industry with accurate lab testing and help the OHA shed more light on issues surrounding consumer safety.

goodchem.exter

Dispensary Best Practices: A Q&A with Stephen Spinosa

By Aaron G. Biros
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Stephen Spinosa, vice president of retail operations at Good Chemistry, has over seven years of experience working in the cannabis industry in the operation and management of licensed dispensaries.

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Stephen Spinosa, VP of retail operations at Good Chemistry, delivering the keynote at Dispensary Next

He was previously an inventory manager in a 7,000-square-foot medical marijuana cultivation in Colorado. Spinosa is currently part of the team at Good Chemistry dispensaries, which has locations in Aurora and Denver, Colorado. He oversees staff training, state and local regulatory compliance and seed-to-sale inventory tracking.

Spinosa recently delivered a keynote presentation at the Dispensary Next Conference in Portland, Oregon titled “From Waiting Room to High-End Retail Experience: How Dispensary Culture Has Changed from 2009 to Now.” He discussed the rise of high-end experience and gave tools for dispensaries to improve retail operations.

In the presentation, he covered supplier quality, security, tiered pricing, inventory tracking and safety issues. Much of what he discussed revolved around the consumer experience and how important the culture at a dispensary is for the buying experience. After his keynote presentation, I sat down with Spinosa to discuss the customer experience, consumer education and safety and sales trends.

Cannabis Industry Journal: What are some of the key areas where dispensaries can improve the quality of customer experience?

Stephen Spinosa: Ultimately, the dispensary experience is like any retail experience. Good Chemistry’s staff is always friendly, smiling, welcoming and helpful to all customers that walk through our doors. Having employees who are experts at providing advice to any user level, and who are extremely knowledgeable on each strain and edible effect is extremely important to us. It is all about making the customer feel comfortable in their experience, especially for novice users who may feel timid when entering a dispensary for the first time.

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Smiling employees greet customers in a clean environment

Good Chemistry’s high-end retail experience includes our up-to-date LED menu screens that present our daily flower menu. That may seem like common sense, however, you would be surprised how many dispensaries do not have a flower menu for their customers to peruse.  It helps the customer navigate through all the strains that we offer, and adds to the overall retail experience. We offer twenty or more strains every day.

Additionally we do not have an armed guard hovering at the entrance, making our guests feel uncomfortable. We have highly sophisticated security, like every dispensary, but we’ve left out this intimidating and unnecessary aspect.

CIJ: Can you discuss what you and your employees do for consumer education and safety?

Spinosa: When introducing cannabis to consumers, it is our mission to educate our customers on the correct dosage based on experience level. Our bud tenders are trained to ask a lot of questions before recommending anything. If a customer is a first timer, the bud tenders will have certain recommendations based on their experience level, such as high-CBD [cannabidiol] flower, a low THC percentage vaporizer pen, or a 1-5mg edible serving.

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The exterior of a Good Chemistry dispensary

That said, strains of cannabis often cannot be neatly compartmentalized into sativa vs. indica, so our bud tenders also educate customers about the entourage effect, the interaction of the various compounds in marijuana to produce each strain’s unique feeling.

We have developed a pioneering category system to help our customers, whether novice or connoisseur. The system is broken down into four main categories to help consumers decide what sensation they would like to experience: stimulation, relaxation, sleep or relief. We use the four categories to guide our customers through our daily flower menu by labeling each strain with a category.

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This wall display shows customers the Good Chemistry categories of strains

If a customer is purchasing edibles, we provide an Edibles Education brochure from the Cannabis Business Alliance that stresses the Start Low, Go Slow motto. We also educate consumers on the difference between edibles made with butter vs. oil. Additionally, all of our third party vendor edible products for adult-use are packaged safely in 100% child resistant packaging.

It is important that our customers have a great experience, which is always possible with good guidance. A happy customer is a repeat customer. We are also well aware of the importance of educated employees. Our employees go through a formal training program, and we have monthly meetings where vendors come in and educate the employees on how to sell and dose various products.

CIJ: Can you tell me about your inventory and some consumer trends you are noticing?

Spinosa: Flower is the biggest seller, and for good reason: we have award-winning strains that are $30 an eighth, every strain, every day. Not many dispensaries offer such incredible pricing. Right now, the purchasing trend tends to lean toward the strains that have the highest THC percentage.

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The interior of the dispensary has digital displays and ample lighting.

This may not accurately depict the best strains, because there have been findings that the entourage effect means different strains can have unique lifts, but it is definitely what the industry is seeing as far as sales trends. As far as edibles, gummies are the biggest sellers followed by hard candies, chocolate and baked goods. Lastly, concentrates such as live resin, shatter and wax have increased in popularity. Good Chemistry produces a new product called solvent-less rosin, concentrated THC oil that is produced using just heat and pressure. Rosin is currently picking up a good amount of traction, although not many dispensaries currently offer it.