ASTM International, the renowned global standards body, has established a new subcommittee, D37.92, aimed at facilitating the exchange of ideas and information between policymakers, regulatory bodies, scientists, stakeholders and the public.
According to a press release, the new subcommittee, at the request of the U.S. Senate, has provided comments on the proposed Cannabis Administration and Opportunity Act (CAOA). The comments including the sharing of ASTM’s work in the cannabis industry, their organization, membership information, defining cannabis terms and their published standards related to facilities, consumer safety and other areas.
David Vaillencourt, frequent contributor to CIJ and chair of the new subcommittee
The subcommittee is headed up by David Vaillencourt, founder & CEO of The GMP Collective and frequent contributor to Cannabis Industry Journal. “With a patchwork of regulations across state, federal, and international levels, this subcommittee will be valuable to industry and government stakeholders as a means to collaborate,” says Vaillencourt, current chair of the new government liaison subcommittee. “It’s really going to facilitate dialogue that will be key as we look ahead to a global marketplace in the coming years.”
ASTM has been working with the cannabis industry through their D37 committee since March of 2017. Soon after the D37 committee launched, they began crafting cannabis standards and have grown their membership and subcommittees considerably over the past few years. In August of this year, they announced the development a new voluntary, consensus-based standard, the Change Control Process Management standard. The new committee, D37.92, is currently seeking public participation in their work to develop the new standard. To learn more about cannabis committee participation and membership, click here.
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.
Steve Stadlmann has an extensive background as an analytical chemist working in laboratories since the early 90’s. He is now a sales specialist at PerkinElmer, an analytical instrument manufacturer that provides instruments for cannabis testing labs, in addition to a host of other industries. With over two decades of experience working in environmental testing labs, food and beverage labs and agricultural testing labs, Stadlmann is extremely familiar with the instruments used in cannabis labs.
Steve Stadlmann, sales specialist at Perkin Elmer
In 2014, he started working in the cannabis space with TriQ, Inc., a technology solutions provider for cannabis growers, where he worked in product development on a line of nutrients. In April of 2016, he started working at Juniper Analytics, a cannabis-testing laboratory in Bend, Oregon. As laboratory director there, he created their quality manual, quality assurance plan, SOP’s and all the technical documentation for ORELAP accreditation. He developed new methodologies for cannabis testing industry for residual solvents, terpene profiles and potency analysis. He worked with PerkinElmer on pesticide methodology for the QSight™ Triple Quadrupole LC/MS/MS system and implemented operational procedures and methods for LC-UV, GCMS and LC-MS/MS, including sample prep for cannabis products.
He left Juniper Analytics about two months ago to work with PerkinElmer as a sales specialist. With extensive experience in helping get Juniper’s lab accredited, he is a wealth of knowledge on all things cannabis laboratory accreditation. PerkinElmer will be hosting a free webinar on September 12th that takes a deep dive into all things cannabis lab accreditation. Ahead of the upcoming webinar, Getting Accreditation in the Cannabis Industry, we sit down with Stadlmann to hear his observations on what instruments he recommends for accreditation, and processes and procedures to support that. Take a look at our conversation below to get a glimpse into what this webinar will discuss.
CannabisIndustryJournal: How can cannabis labs prepare for accreditation with selecting instrumentation?
Steve: Finding the appropriate instrumentation for the regulations is crucial. Ensuring the instrumentation not only has the capabilities of analyzing all the required compounds, but also able to achieve appropriate detection limit requirements. In addition, having an instrument manufacturer as a partner, that is willing and able to assist in method development, implementation and continued changes to the testing requirements at the state level (and potentially national level) is key.
Another consideration is robustness of the equipment. The instrumentation must be capable of high throughput for fast turnaround times of results. Unlike the environmental industry, the cannabis industry has consumer products with expiration dates. Clients demand quick turnaround of results to get product to market as quickly as possible and avoid sitting on inventory for any length of time.
To add to the robustness need, sample matrices in the cannabis industry can be quite challenging in relation to analytical instrumentation. Equipment that is able to handle these matrices with minimal downtime for routine service is becoming a requirement to maintain throughput needs of the industry.
CIJ: What are the most crucial procedures and practices for achieving ISO 17025 accreditation?
Steve: Development and documentation of processes and procedures following Good Laboratory Practices and procedures is essential to a successful accreditation process. Great attention must be paid to the quality objectives of the laboratory as well as associated documentation, including tracking of any errors, deviations, updates, complaints, etc.
Data integrity is a key component to any accrediting body and includes implementation and/or development of appropriate methods with support data proving acceptable results. In addition, documentation of all procedures and processes along with tracking of all steps in the process during routine laboratory work should be a priority. The ability to show a complete, documented trail of all procedures done to any sample is important in ensuring the results can be reproduced and ensuring no deviations occurred, in turn potentially causing questionable results.
Last but not least: training. Laboratory staff should be well versed in any procedures they are involved in to ensure high data quality and integrity. If any laboratory staff does not receive appropriate training in any operating procedures, the data quality becomes suspect.
CIJ: What are some of the biggest obstacles or pitfalls cannabis labs face when trying to get accredited?
Steve: Not fully preparing to meet any agency and testing regulations and requirements will cause delays in the accreditation process and potentially more work for the laboratory. From documentation to daily operations, if any aspect becomes a major finding for an auditor, additional data is usually required to prove the error has been fixed satisfactorily.
Taking the time early on to ensure all documentation, processes and procedures are adhering to any regulatory agency requirements is important for a smooth accreditation process. It is easy to overlook small details when building out the operating procedures that might be essential in the process. Again, going back to data quality, the laboratory must ensure all steps are outlined and documented to ensure high quality (reproducible) data and integrity.
A new employee should be able to come in and read a quality manual and standard operating procedure and produce equivalent data to any laboratory analyst doing the same job. With difficult or challenging operating procedures it becomes even more important that training and documentation are adhered to.
PerkinElmer’s free webinar will dive into these points and others in more detail. To learn more and sign up, click here.
Lezli 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
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 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.
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
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.
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.”
By Olivia L. Dubreuil, Esq., Brett Giddings No Comments
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.
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.
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.
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.
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.
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:
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.
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.
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?
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.
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.”
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.”
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.
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.
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According to a press release, the new subcommittee, at the request of the U.S. Senate, has provided comments on the proposed Cannabis Administration and Opportunity Act (CAOA). The comments including the sharing of ASTM’s work in the cannabis industry, their organization, membership information, defining cannabis terms and their published standards related to facilities, consumer safety and other areas.
