Organic Cannabis Association & Ethical Cannabis Alliance Announce Merger

By Aaron G. Biros
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The Organic Cannabis Association and Ethical Cannabis Alliance announced today they are merging into one organization, the Cannabis Certification Council (CCC), according to a press release. The new third-party certifications include “Organically Grown” and “Fairly Produced”, granting producers a seal for marketing if they achieve the certifications.

Ashley Preece, executive director of the Cannabis Certification Council

According to Ashley Preece of the Ethical Cannabis Alliance, now executive director at CCC, they plan on starting with the “Organically Grown” certification as first certification to market. “We are launching with Organically which will include robust labor standards as well as standards that go beyond [USDA] Organic,” says Preece. “The USDA Organic standard is watered down and we want to expand on proper horticulture practices so it relates directly to cannabis producers.” The process of designing that certification involves using that USDA Organic certification as a building block to draw from but not directly adopt.

“We will start by pulling from Organic and Fair Trade standards, then we will have a technical advisory committee (TAC), made up of multi-stakeholder agricultural industry and cannabis industry professionals to give input and adjust the standard accordingly,” says Preece. “From there we will have a pilot program, engaging with producers abiding by the standards’ requirements. After the pilot phase, we make final adjustments before bringing it to market.” In order to make sure their certification works across the board, Preece says they are engaging with stakeholders around the country and eventually globally. “We need to engage each different community to make sure this is applicable on a national level.” Preece also says they plan staying abreast of other standards, such as ASTM International’s, but those are geared more towards production safety. “We are looking towards more robust Organic and Fair Trade standards, and ‘cannabinizing’ them,” says Preece.

Photo courtesy of L’Eagle Services

David Bronner, a prominent advocate of drug policy reform and CEO of Dr. Bronner’s, a top-selling soap brand in the US market place, will be providing seed funding and a matching grant to the CCC. “We are committed to making socially and environmentally responsible products of the highest value, and we are excited for the CCC to begin driving that ethos in the cannabis industry,” says Bronner. “The Cannabis Certification Council (CCC), with its unique mission, is a perfect vessel for us to support our values in the cannabis space.”

Preece says the “Fairly Produced” labor certification is going to be based off of Fair Trade practices. “That will include living wages per community and taking options of ownership into consideration, including different business models where employees might have shares or partial ownership,” says Preece. “As we know, this industry has come from the illicit market, where we saw a lot of inappropriate working environments, gender relations and pay schedules. So we want to ensure that workers have contracts in place, they are treated fairly just as any other industry and we want to mitigate any strange encounters that might have seeped into this regulated market.” Founding board members include Laura Rivero of Yerba Buena Farms; Amy Andrle of L’Eagle Services Denver; Nick Richards of Dill and Dill and Vicente Sederberg; and Ben Gelt of Par, with Ashley Preece as executive director. “This is a huge step for the cannabis industry,” says Preece. “Our collaboration reflects the priority of the mission ingrained in both parties, and together we will immediately be greater than the sum of our parts.”

Washington Selects Franwell’s METRC for Traceability Program

By Aaron G. Biros
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The Washington State Liquor and Cannabis Board (WSLCB) announced today they plan to choose Franwell as their technology partner for the state’s cannabis seed-to-sale traceability system. While the release states they have not yet officially awarded them the contract, it says Franwell is the apparent successful vendor (ASV) to replace their current system. “An ASV is the procurement term used for the highest scoring, responsive vendor,” says the press release.

Rick Garza, director of the WSLCB, says they plan on making a number of changes that they couldn’t under their current contract. “Over the last four years we have learned a lot about this industry, including aspects to the industry that were unknown when the current traceability system was implemented,” says Garza. “We need a system that will grow and flex with Washington’s maturing marijuana system.”

Seven companies submitted bids for the new contract and the agency narrowed that down to three finalists, each of which gave presentations and demonstrations on their software products to WSLCB staff last week. They also worked with folks in the cannabis industry, selected by trade organizations, that provided input on the requests for proposal. Those industry stakeholders that participated with input will get a demonstration of the new software system in early June.

They plan on transitioning to the new system no later than October 31, 2017. Franwell’s METRC product is currently used in Colorado, Oregon and Alaska.

A2LA Accredits First Cannabis Testing Laboratory in Washington State

By Aaron G. Biros
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The American Association for Laboratory Accreditation (A2LA) announced today that they just accredited the Washington State Department of Agriculture-Chemical and Hop Laboratory to ISO 17025. The laboratory, based in Yakima, WA, finished the accreditation process on May 3, 2017.

The lab was accredited to ISO/IEC 17025 – General Requirements for the Competence of Testing and Calibration Laboratories, so they are now able to test for pesticides in cannabis and other matrices, according to the press release published today. “WSDA sought this accreditation to ensure our clients can have absolute confidence in our testing methods and lab results. The information we produce drives enforcement cases and policy decisions,” says Mike Firman, manager of the WSDA Chemical and Hop Laboratory. “We want to do everything that can be done to make sure our data is reliable.”

The A2LA Cannabis Accreditation Program is essentially a set of standards for quality in testing cannabis and cannabis-based products, such as infused products, tinctures and concentrates. ISO 17025 accreditation is quickly become a desirable certification for laboratories. Many states strongly encourage or even require ISO 17025 accreditation for cannabis laboratories. California recently released a set of proposed lab testing regulations for the cannabis industry that specifically requires an ISO 17025 accreditation in order for laboratories to issue certificates of analysis.

Because each state’s requirements for laboratories testing cannabis varies so greatly, A2LA works with state regulators to craft their accreditation program to meet each state’s specific requirements. “A2LA is excited to play such an important role in the accreditation of cannabis testing laboratories and is pleased to see ISO/IEC 17025 accreditation expanding into additional states,” says A2LA General Manager Adam Gouker. “Priority must be placed on ensuring that cannabis products are tested by competent laboratories to convey confidence in the results – a cornerstone which underpins the safety to all end-users.” A2LA is currently accepting applications for cannabis laboratories working to receive accreditation. Labs that already have ISO 17025 accreditation and are in a state with legal cannabis, have the ability to expand their scope of accreditation if they are looking to get into cannabis testing.

California Releases Draft Lab Testing Regulations

By Aaron G. Biros
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Last Friday, the Bureau of Marijuana Control, the regulatory body overseeing California’s cannabis industry, released a set of proposed regulations for the lab testing market. The regulations are somewhat comprehensive, covering sampling, licensing, pesticide testing, microbiological contaminants, residual solvents, water activity and much more.

Formerly named the Bureau of Medical Cannabis Regulation under the state’s Department of Consumer Affairs, the Bureau of Marijuana Control is tasked with overseeing the development, implementation and enforcement of the regulations for the state’s cannabis industry. In their statement of reasons for the lab testing regulations, the bureau says they are designed with public health and safety at top of mind. At first glance, much of these laboratory rules seem loosely modeled off of Colorado and Oregon’s already implemented testing regulations.

The regulations lay out requirements for testing cannabis products prior to bringing them to market. That includes testing for residual solvents and processing chemicals, microbiological contaminants, mycotoxins, foreign materials, heavy metals, pesticides, homogeneity as well as potency in quantifying cannabinoids.

The microbiological impurities section lays out some testing requirements designed to prevent food-borne illness. Labs are required to test for E. coli, Salmonella and multiple species of the pathogenic Aspergillus. If a lab detects any of those contaminants, that batch of cannabis or cannabis products would then fail the test and could not be sold to consumers. A lab must report all of that information on a certificate of analysis, according to the text of the regulations.

The proposed regulations stipulate requirements for sampling, including requiring labs to develop sampling plans with standard operating procedures (SOPs) and requiring a lab-approved sampler to follow chain-of-custody protocols. The rules also propose requiring SOPs for analytical methodology. That includes some method development parameters like the list of analytes and applicable matrices. It also says all testing methods need to be validated and labs need to incorporate guidelines from the FDA’s Bacterial Analytical Manual, the U.S. Pharmacopeia and AOAC’s Official Methods of Analysis for Contaminant Testing, or other scientifically valid testing methodology.

Labs will be required to be ISO 17025-accredited in order to perform routine cannabis testing. Laboratories also need to participate in proficiency testing (PT) program “provided by an ISO 17043 accredited proficiency-test provider.” If a laboratory fails to participate in the PT program or fails to pass to receive a passing grade, that lab may be subject to disciplinary action against the lab’s license. Labs need to have corrective action plans in place if they fail to get a passing grade for any portion of the PT program.

ASTM International Begins Crafting Cannabis Standards

By Aaron G. Biros
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Last week, the American Society for Testing and Materials (ASTM International) approved the formation of a committee to develop standards for the cannabis industry. ASTM International is a standards development organization that develops voluntary consensus-based standards for industries. United States regulatory bodies and the World Trade Organization have recognized the organization’s standards in other industries.

On March 1st, the non-profit announced the formation of a committee for ““creating technical standards and guidance materials for cannabis and its products and processes.” So now that the vote has passed, what is the next step? They will begin the process of member training, appointment of leadership and writing the bylaws. ASTM will have two online briefings before their official meeting for the cannabis committee (D37) in June. Those meetings will discuss how the committee was formed and how it’ll be structured. The first official meeting of the cannabis committee will take place June 11th and 12th in Toronto.

Lezli Engelking
Lezli Engelking, founder of FOCUS

Voluntary consensus-based standards means there is a balance of interests, an appeals process and an overall consensus has been reached. The areas of focus for the cannabis standards include indoor and outdoor horticulture and agriculture, quality management systems, laboratories, processing and handling, security and transportation, and personnel training, assessment and credentialing. Many standards will be developed under each of these broad categories. A large component of consensus-based standard development is openness…so anyone who wants to participate in the development of the standards is welcome and encouraged to do so. They are still looking for participants from the cannabis industry and those interested can register here.

Lezli Engelking, founder of the Foundation of Cannabis Unified Standards (FOCUS), says this is terrific news for the cannabis industry. “To have a global organization like ASTM, that federal governments actually work with and respect, is a huge stride forward for the cannabis industry,” says Engelking. “FOCUS is thrilled to be working with ASTM.” FOCUS and ASTM International have a derivative work license agreement that provides ASTM the FOCUS standards to use as a baseline for developing their standards. “FOCUS will continue to certify cannabis businesses to the FOCUS standards, but we will be able to add in the ASTM standards to our certification platform,” says Engelking. “It helps us expand our depth and reach in tools for our clients.”

FOCUS standards and ASTM standards are both voluntary consensus-based, meaning it is the businesses and stakeholders participating that ultimately write the standards. The organizations’ staff does not actually contribute to and develop the standards; they are more like a vehicle for the industry and stakeholders to come to a consensus, according to Engelking. “ASTM does the same thing that we do for the cannabis industry, just on a much larger scale,” says Engelking. “Its role is to fulfill the development, not actually develop it.” Because of that, ASTM and FOCUS standards can work in harmony.

BioTrackTHC Awarded Delaware’s Tracking Software Contract

By Aaron G. Biros
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According to a press release, the State of Delaware has chosen BioTrackTHC as their partner in seed-to-sale tracking software. Delaware’s Department of Health and Social Services (DHSS) signed a contract with BioTrackTHC for the tracking and patient registry software.

In 2016, Delaware issued a request for proposals for “the Delaware Enterprise Consolidated Cannabis Control System,” which encompasses the statewide patient registry and seed-to-sale traceability systems. “Our sincerest thanks to DHSS for choosing Team BioTrack,” says Patrick Vo, CEO of BioTrackTHC. “DHSS has been wonderful to work with throughout the contracting process, and we look forward to partnering with them to provide the tools and data they need to continue overseeing the industry and protecting their patients.” BioTrack’s software was selected as the winner of a number of government contracts in other states previously for the same role.

Their software is currently used in government traceability systems in Washington, New Mexico, Illinois, Hawaii, New York and the city of Arcata, California. The press release states regulators will have the ability to view the retail data “including plant counts and usable inventory, lab results, transportation, and point-of-sale data—to perform periodic audits and ensure compliance.” The patient registry will also provide better patient accessibility through the new software with a faster turn around time and automated application processing.

BioTrackTHC provides technology solutions for businesses and governments to tracking products throughout the supply chain to the point of sale. The software systems help businesses remain compliant with regulations and monitor data for things like inventory management.

California Releases Draft Medical Cannabis Regulations

By Aaron G. Biros
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Last week, Governor Brown’s Administration released a set of proposed rules for the medical cannabis, attempting to provide some oversight to the once unregulated market. In 2015, the governor signed three bills into law that established a regulatory framework via the Medical Cannabis Regulation and Safety Act. That legislation set up the Bureau of Medical Cannabis Regulation inside the Department of Consumer Affairs as the overseeing regulatory agency.

According to the press release, the proposed regulations for manufacturing and cultivation have also been published. “The proposed licensing regulations for medical cannabis are the result of countless hours of research, stakeholder outreach, informational sessions and pre-regulatory meetings all across the state,” says Lori Ajax, chief of the Bureau of Medical Cannabis Regulation. “And while we have done quite a bit of work and heard from thousands of people, there is still so much more to do. In order to make our program successful we still need your feedback.”

According to their website, the legislation divides responsibility for licensing businesses between three regulatory bodies: The CA Department of Food and Agriculture the CA Department of Public Health and the Bureau of Medical Cannabis Regulation, which will be the leading body in charge of licensing. The proposed regulations are not set in stone, but give us an important glimpse into how the state hopes to regulate the market.

Among the proposed rules are a number of regulatory compliance nuances expected to raise prices, but provide extra measures to protect consumer safety. According to the SF Gate, regulators expect prices could climb $524 per pound. But with that price jump comes a lot of regulations that other states have so far successfully implemented. The laboratory testing and traceability stipulations are presumably designed to safeguard public health, preventing things like black market diversion and off-label pesticide use.

The proposed ‘cannabis product symbol’

In addition to the medical regulations, the proposed manufacturing regulations set some notable requirements. Those rules are set by the Office of Manufactured Cannabis Safety, established in the Center for Environmental Health of the California Department of Public Health (CDPH) after the 2015 legislation was signed into law. Good Manufacturing Practices, food product standards, operational and labeling requirements are included in the provisions, along with a list of licensing tiers, application requirements and fees. They have a handy summary of the proposed regulations for those looking for the key highlights.

Omar Figueroa, an attorney with a cannabis law practice in California, says his clients in the industry are preparing to suggest changes to the proposed regulations and possibly legal challenges. “They are looking at this as overregulation by people that are not in the cannabis industry,” says Figueroa. “These are outsiders with a limited knowledge base creating somewhat uninformed regulations.” He says a good example of this is the potency limit on infused products. “They make perfect sense for [the recreational market] but for the medical market it is simply unacceptable. Patients develop a tolerance to THC and would have to increase their caloric intake and buy more infused products if this proposed regulation becomes final.” He says there are a number of regulations that seem kind of arbitrary. “Like prohibiting cannabis-infused caffeine products; there doesn’t seem to be a necessity in the rulemaking for this,” says Figueroa. “A lot of these regulations are going to be susceptible to challenges because California requires regulations to be necessary and alternatives to be considered.”

Although the lab testing regulations won’t be published for another few days, Figueroa expects them to be a huge disruptor for the market. “Most labs in the state are not ISO 17025-accredited, which means many labs might not be able to issue certificates of analysis when the regulations get enforced,” says Figueroa. He says it is safe to say California regulators are looking at other jurisdictions, like Colorado and Oregon for example, in crafting these rules, but we can expect a sea change in these regulations before they get enforced.

Manufacturers will be required to use a cannabis product symbol with a ‘THC!’ marking on their labels. There is also a 100-milligrams-per-package limit for THC in infused products, which is similar to rules we saw Colorado and Oregon roll out during a preliminary period of legal recreational cannabis.

For those looking to get involved in the regulatory process, there is a 45-day comment period on the proposed rules.

Congress Passes Budget With Protections for Medical Cannabis

By Aaron G. Biros
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On May 1st, Congress reached a bipartisan deal to keep the government open and funded through September 30th, 2017. Congress approved the appropriations bill that sets the government’s spending with an important section in it relating to cannabis. Section 537 on page 230 states that the Department of Justice cannot use funds to interfere with states’ legal medical cannabis programs.

The bill uses similar language to The Rohrabacher–Farr amendment, a bill that was originally introduced in 2013 to prevent the Department of Justice from spending money on enforcing the Controlled Substances Act in states with legal medical cannabis programs. This new appropriations bill, with the language in section 537, effectively achieves the same thing. “None of the funds made available in this Act to the Department of Justice may be used, with respect to any of the States of… to prevent any of them from implementing their own laws that authorize the use, distribution, possession, or cultivation of medical marijuana,” reads the bill. The language includes a mention of the 40 or so states and territories with some form of medical cannabis program, legislation or bill.

The language of section 537 (second half)

This means that Attorney General Jeff Sessions is relatively powerless to go on a sort of ‘crackdown’ on medical cannabis programs. Given Sessions’ previous comments and general views on cannabis, this should put cannabis industry stakeholders at ease for the time being. Of course, this budget is only for the 2017 fiscal year, so come September, the same or similar language needs to be included in the next appropriations bill. With Jeff Sessions’ task force still investigating federal cannabis policy, it is still very possible we could get a clear policy decision in the near future.

“We are encouraged that the Federal Government and NIDA are recognizing the true and powerful medical benefits that cannabis provides, especially in the war against devastating opiate-based drug addiction, abuse and death,” says Sally Vander Veer, President of Medicine Man Denver. “We have seen anecdotal evidence of this as reported by our patients/customers (and the beneficial effects of cannabis in numerous other conditions) since we opened our doors in 2010. Our hope is that this acknowledgment will open the door to additional research, eventually leading to legal and safe access to cannabis medicine for all Americans.”

The following section also includes a protection of industrial hemp research, as defined in the Agricultural Act of 2014, which basically means universities and institutions can research it. SEC. 538. “None of the funds made available by this Act may be used in contravention of section 7606 (‘‘Legitimacy of Industrial Hemp Research’’) of the Agricultural Act of 2014 (Public Law 113–79) by the Department of Justice or the Drug Enforcement Administration.” With all of the uncertainty and inconsistent comments coming out of the Trump administration, at least we have a sense of security in the medical cannabis community through the summer.

Colorado Issues Safety Advisory Over Pesticide Contamination Concerns

By Aaron G. Biros
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The Colorado Department of Revenue (DOR), in conjunction with the Colorado Department of Agriculture (CDA) and the Colorado Department of Public Health and Environment (CDPHE) issued two public health and safety advisories this morning after they identified pesticide residues on dried cannabis flower, trim, concentrates and infused products, according to the advisory. The contaminated products come from cannabis grown by Rocky Mountain Ways, LLC and Herbal Options, LLC, both doing business as Good Meds.

The Advisory was issued at 10am MT this morning

The advisory cautions consumers to check their labels for the license numbers of the businesses and the harvest batch numbers. They list the license number as, “Medical Optional Premises Cultivation License 403-001116 and/or Medical Marijuana Center License 402-00736.” The harvest batch numbers in question are B11H15.041317-Headband, B11H15.041317-Night Terror OG, and B11H15.041217-Citrix.

The CDA found the presence of off-label pesticides, including Pyrimethanil, Tebuconazole, and Spinosyn, in the products. Pyrimethanil is a fungicide commonly used on seeds, but it is generally regarded as not acutely toxic to humans. Tebuconazole is another fungicide, while the FDA says it is safe for humans, other sources say it could have a moderate acute toxicity in humans. Spinosyn is a class of insecticides with a slight acute toxicity to humans and has been the culprit in a previous cannabis recall in Oregon. In the public health and safety advisory, the CDPHE and DOR say the pesticides were used off-label and none of them are on the approved list of pesticides for cannabis.

The license numbers and batch harvest numbers in question
israel flag

Israeli Cannabis Brand Tikun Olam Expands to US

By Aaron G. Biros
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israel flag

Tikun Olam is a Jewish concept that addresses social policy, promoting acts of kindness to better society. In Hebrew, it literally means, “repair of the world.” The company by the same name, Tikun Olam Ltd, and now in the United States as T.O. Global LLC, was the first medical cannabis provider in Israel back in 2007. Working with patients, doctors and nurses in clinical trials, they developed 16 strains over the last decade that target alleviating symptoms of specific ailments.

Tel Aviv, Israel, where Tikun Olam has a dispensary

In November 2016, they launched their United States brand, Tikun, in the Delaware medical cannabis program with their partner, First State Compassion Center, a vertically integrated business of cultivation, extraction and retail in Wilmington. After the success of their pilot program, Tikun announced their expansion into the Nevada market with their licensed partner, CW Nevada LLC. Tikun is leveraging its experience with clinical trials and medical research to launch a line of cannabis products focused on health and wellness in the United States. According to Stephan Gardner, chief marketing officer at Tikun Olam, they have the largest collection of medical cannabis data in the world. “Tikun Olam started out as a non-profit, working to bring medication to patients in Israel,” says Gardner. “Opening nursing clinics gave us a tremendous amount of knowledge and data to work on the efficacy of strains developed specifically for targeting symptoms associated with certain conditions.” For example, their strain, Avidekel, was developed years ago as the first high-CBD strain ever created.

cannabis close up
The strain Avidekel being grown in Israel.

In a single-strain extraction, Avidekel has been used to successfully mitigate the symptoms associated with neurological conditions, like epilepsy in children, and they have the data to demonstrate that efficacy. “The American market needs some sort of guidance on how these cannabinoid and terpene profiles in certain strains can truly assist patients,” says Gardner. “We have been tracking and monitoring our patients with clinical and observational data in one, six month and annual follow ups, which are data we can use to guide the needs in the US.”

Their expansion strategy focuses heavily on the health benefits of their strains, not necessarily targeting the recreational market. “As a wellness brand in Nevada, we are positioned to work first and foremost in the medical market,” says Gardner. “Our wellness brand can cater to people looking for homeopathic remedies for things like inflammation issues, sleep disorders or pain relief for example,” says Gardner. “You will not see us going out there catering to the truly recreational market; the benefits of what our strains can do is marketed from a wellness perspective.” A cannabis product with high-THC percentages is not unique, says Gardner, but their approach using the entourage effect and proven delivery mechanisms is. “While higher THC might appeal to the rec market, that is not exactly how we will promote and position ourselves,” says Gardner. “We want to be a dominant force in the wellness market.”

Best practices include quality control protocols

That effort requires working within the US regulatory framework, which can be quite complicated compared to their experience in Israel. “We have to understand the Israeli market and American market are completely different due to the regulatory regimes each country has in place,” says Gardner. “We understand the efficacy of these products and want to educate customers on how they might benefit. We don’t want to make claims looking to cure anything, but we found in our data that a lot of symptoms in different ailments, like cancer, PTSD, Crohn’s disease, colitis and IBS, can be alleviated by strains we developed.” In addition to the medical research, they are bringing their intellectual property, cultivation methodologies, evidence-based scientific collaboration and best practices to their partners in the US.

So for Tikun’s expansion in the US, they want to get a medical dialogue going. “We will launch a fully accredited AMA [American Medical Association] program, educating medical practitioners, giving the doctors the understanding of the capabilities of cannabis and what our strains can do,” says Gardner. “We will also share our observational data with doctors so they can work to better guide their patients.” Right now, they are working on the education platform in their pilot program in Delaware. “We plan on using that as a platform to expand into other markets like Nevada,” says Gardner. “And we will be launching the Tikun brand in the Washington market this summer.” Based on the high demand they saw in the Delaware market, Gardner says they plan to launch six unique strains in the American market, with delivery mechanisms like vape products, tinctures, lozenges and topicals in addition to dried flower.

dry cannabis plants
Rows of cannabis plants drying and curing before processing.

While Tikun expands throughout the United States, their sights are set on global expansion, living up to the true meaning of the concept Tikun Olam. They entered a strategic partnership with a licensed producer based in Toronto, bringing their strains, including Avidekel, to the Canadian market. The company they are partnering with, MedReleaf, recently filed for an initial public offering (IPO) on the Toronto stock exchange. Tikun Olam is actively seeking to expand in other parts of the world as well.