In the first part of this series, Michelle Bradac, senior accreditation officer at the American Association for Laboratory Accreditation (A2LA), told us about the basics of laboratory accreditation, what it means and why it is such a cornerstone of product safety. In this next piece, we sit down with Roger Brauninger, A2LA Biosafety Program manager, to learn why states are looking to lab accreditation in their regulations for the cannabis industry.
Brauninger has worked at A2LA since 1999. As the manager of their biosafety program, his focus is on developing and maintaining accreditation programs in the life sciences. Brauninger has conducted a number of management system assessments to ISO/IEC 17025 and 17020 and also evaluates other assessors in this role.
He is A2LA’s point person for interacting with organizations working with food and drug safety, human and animal anti-doping, biological and chemical threat agents and since 2014 for issues related to cannabis testing. He is a member of the ASTM D37 Cannabis committee, a group focused on creating standards for cannabis products. He was also a member of the stakeholder panel on strategic food analytical methods (SPSFAM) cannabis potency working group when they were awarded the Official Methods Board (OMB) award for achievement in technical and scientific excellence at the AOAC’s Annual Meeting and Exposition in Atlanta, GA. Brauninger holds an M.S. degree in Cellular, Microbial and Molecular Biology from George Mason University and is a member of the Society for Toxicology, AOAC International and the International Association for Food Protection (IAFP).
In this part of the series, we sit down with Brauninger to learn specific requirements in states, some of the benefits of using ISO/IEC 17025 and the influx of start-up or novice testing laboratories. Stay tuned for part three.
CannabisIndustryJournal: Do all states with legalized medical cannabis require the testing to be performed by an ISO/IEC 17025 accredited laboratory?
Roger Brauninger: No not at present, while most of the states where cannabis is legal do require accreditation; there are some states that have no requirements dealing with ensuring the competence of the testing laboratories, some that require the labs to be accredited to state environmental and drinking water standards, some that require laboratories adhere to Good Laboratory Practices (GLP) requirements and some have no requirements in place currently. Now, there are roughly 13 states that require or recommend accreditation of the testing laboratory to ISO/IEC 17025.
CIJ: If and when cannabis use is accepted federally, how is ISO/IEC 17025 accreditation of testing laboratories beneficial?
Roger: The accreditation process provides a uniform platform to allow for comparability of test results between states. This would also allow for these laboratories to benefit by being able to expand their customer base, if state borders were not an artificially imposed barrier to trade. This could also help to raise the quality of the testing services by allowing for greater participation in realistic accredited proficiency testing programs, which can create greater comparability of methods and results.
CIJ: What are the benefits to the states by choosing to require ISO/IEC 17025 accreditation as a basis for competence of testing laboratories?
Roger: States face the unique challenge, due to the federal illegality of cannabis, that they must craft their own regulatory cannabis program requirements. The ISO/IEC 17025 requirements provides a means upon which to recognize laboratory competence. This saves the states from having to come up with their own laboratory quality management requirements detailing the necessary activities a laboratory must address with respect to documentation, chain of custody, method validation, etc. Because these items are already considered in the standard. ISO/IEC 17025 helps to creates a baseline consistency amongst laboratories between states. And It also helps to provides for the legal defensibility of the test results. If and when cannabis is legalized on a federal level, a uniform 50 state recognition is possible using ISO/IEC 17025 as the basis of recognition. In short accreditation can help to ensure that test results have greater comparability and reliability; It also provides greater trust and confidence in the labels and the stated ingredients.
CIJ: Many of the laboratories are “starting up”, how is A2LA equipped to deal with the influx of novice laboratories in this field of testing?
Roger: A2LA offers many different relevant training classes, including those on the ISO/IEC 17025 standard itself, (as well as ones that also contain cannabis-specific content), internal auditing, documenting your quality system, etc. for the laboratories. A2LA also is knowledgeable regarding various states’ cannabis regulatory requirements and can help guide the labs through some of the many obstacles they face in order to perform testing in their state.
CIJ: Does A2LA provide any technical assistance to laboratories that are starting up in this industry?
Roger: A2LA has numerous technical assessors who are experts in the analytical technology associated with cannabis testing. Assessors can be hired in a consulting role and act independently of the assessment process (and independent of A2LA). As a consultant, they can also assist in setting up a quality management system in compliance with ISO/IEC 17025.
CIJ: What benefits can be gained from a laboratory seeking accreditation or from a state that requires cannabis testing laboratories to be accredited?
Roger: Accreditation can provide legal defensibility and increased confidence in the test results being able to stand up in court. It also may help to lower the cost of doing business because it helps to ensure that the test methods are in control by the laboratory and has been shown to be able to reduce the need for repeat testing. Laboratory accreditation has also led to reduced insurance rates in some cases.
Ahead of the state’s implementation of their full adult use legalization in early 2018, California is working on improving their public outreach. Last week, the California Department of Public Health launched “Let’s Talk Cannabis”, a website dedicated to consumer education.
About two weeks ago, the Bureau of Cannabis Control, California’s state regulatory body for the cannabis industry, launched a rebranding effort of their own, with a new logo, website and even an Instagram account. Their “Cannabis Portal” is a website dedicated to helping those in the industry get updated information on licensing, new regulations and other news and events.
The Bureau’s upgraded website will better help business owners stay up-to-date on upcoming regulations and licensing applications, according to a press release. Judging by their Facebook (@bccinfo.dca), Twitter (@bccinfo_dca) and Instagram pages, the regulatory body seeks to have a more public presence online than other states’ regulatory bodies.
The state’s three regulatory bodies are featured on the portal. The Bureau of Cannabis Control is just one regulatory arm of the government, basically responsible for licensing dispensaries, distributors and laboratories. The Manufactured Cannabis Safety Branch, a division of the California Department of Public Health (CDPH), will presumably regulate manufacturers of infused products. CalCannabis Cultivation Licensing is under the California Department of Food and Agriculture (CDFA), which will oversee regulating growers of medical and adult use cannabis. That regulatory body is also in charge of the state’s seed-to-sale traceability software system.
The Department of Public Health’s “Let’s Talk Cannabis” website is more of a consumer-focused educational tool. It features frequently asked questions, some links to other resources, information on legalization and information for the youth, parents and pregnant and breastfeeding women. That consumer-facing website offers tips for parents on storing cannabis and keeping it out of reach of children, in addition to advice for responsibly consuming cannabis.
It will be interesting to see how they plan on using those social media pages in the future. At first glance, they could be excellent tools for regulators to communicate with licensees, to help explain common regulatory compliance errors or to provide tips and tricks for staying compliant. The consumer-facing portal could also be a great means for communicating product recalls or public health and safety alerts, things that Colorado and Oregon currently struggle with.
A number of cannabis businesses have pursued federal intellectual property protection for their cannabis-related innovations, such as U.S. patents that protect novel cannabis plant varieties, growing methods, extraction methods, etc. Enforcement of such federal IP rights requires that the IP owner file suit in federal court asserting those rights against another cannabis company. However, given that cannabis is still illegal under federal law, the industry is uncertain about whether a federal court will actually enforce cannabis-related IP rights. This question might be answered soon.
The potential impact of this case goes way beyond the two parties involvedOrochem Technologies, Inc. filed a lawsuit in federal court in the Northern District of Illinois on September 27, 2017, seeking to assert and enforce trade secret rights against Whole Hemp Company, LLC. According to the complaint, Orochem is a biotechnology company that uses proprietary separation methods to extract and purify cannabidiol (CBD) from industrial hemp in a way that produces a solvent-free and THC-free CBD product in commercially viable quantities.
The complaint goes on to say that Whole Hemp Company, which does business as Folium Biosciences, is a producer of CBD from industrial hemp and that Folium engaged Orochem to produce a THC-free CBD product for it. According to the allegations in the complaint, Folium used that engagement to gain access to and discover the details of Orochem’s trade secret method of extracting CBD so that it could take the process and use it at their facility.
The complaint provides a detailed story of the events that allegedly transpired, which eventually led to an Orochem employee with knowledge of the Orochem process leaving and secretly starting to work for Folium, where he allegedly helped Folium establish a CBD production line that uses Orochem’s trade secret process. When Orochem learned of these alleged transgressions, it filed the lawsuit, claiming that Folium (and the specific employee) had misappropriated its trade secret processes for extracting and purifying CBD.
While the particular facts of this case are both interesting and instructive for companies operating in the cannabis industry, the potential impact of this case goes way beyond the two parties involved.
If it moves forward, this case will likely provide a first glimpse into the willingness of federal courts to enforce IP rights that relate to cannabis. Orochem is asserting a violation of federal IP rights established under the federal Defend Trade Secrets Act (DTSA) and is asserting those rights in federal district court. As a result, the federal district court judge will first need to decide whether a federal court can enforce federal IP rights when the underlying intellectual property relates to cannabis.
If the court ultimately enforces these federal trade secret rights, it could be a strong indication that other federal IP rights, such as patent rights, would also be enforceable in federal court. Since the outcome of this case will likely have a far reaching and long lasting impact on how the cannabis industry approaches and deals with intellectual property, it’s a case worth watching.
Laboratories throughout the world and in a variety of industries get accredited to demonstrate their competency. In the cannabis industry, some states are beginning to require it and many labs get accredited even if their state doesn’t require it. So what does accreditation mean and why is it so important?
The International Organization for Standardization (ISO) is a standard-setting organization that works to promote industrial and commercial standards. The standards set by ISO are designed to help prove a product’s safety and quality to a certain minimum level.
The ISO/IEC 17025:2005 standard sets specific requirements to demonstrate the competence of a lab for carrying out tests. It essentially shows customers or regulators that a lab has the skills and scientific know-how to perform testing, certifying the lab is capable. Accreditation means certifying a lab to that standard and is synonymous with both quality and competence of an organization.
The American Association for Laboratory Accreditation (A2LA), founded in 1978, is a non-profit, internationally recognized accreditation body in the United States that offers laboratory and laboratory-related accreditation services and training. They have worked in the cannabis industry to accredit a number of cannabis laboratories to the ISO/IEC 17025:2005 standard. In this series of articles, we sit down with experts from A2LA to learn more about cannabis lab accreditation, why it’s so important and some of the challenges labs face when seeking accreditation.
In the first part of this series, we sit down with Michelle Bradac, senior accreditation officer at A2LA, to learn the basics. Michelle earned a bachelor’s degree in Biology at Towson State University and then attended Hood College, earning a master’s certificate in Regulatory Compliance in Biomedical Science. She has worked at A2LA for eight years, assisting in the accreditation of food testing, environmental testing and cannabis testing laboratories to ISO/IEC 17025, as well as performing quality system assessments. She also facilitates a number of accreditation programs including Field Sampling Measurement Organizations, STAC (Air Emissions) and Cannabis Testing. Bradac is also a member of the ASTM Cannabis Working Group and the ACIL Cannabis Working Group.
In the next part of this series, we will hear about specific requirements in states, some of the benefits of using ISO/IEC 17025 and the influx of start-up or novice testing laboratories.
CannabisIndustryJournal: What is Laboratory Accreditation?
Michelle Bradac: Laboratory accreditation is a formal means of determining and recognizing the technical competence of laboratories to perform specific types of testing, via the use of an independent third party accreditation body. It provides laboratory users a mechanism to identify and select reliable testing organizations. Use of ISO/IEC 17025 as a basis for laboratory accreditation is internationally recognized as THE conformity assessment standard to which laboratories are accredited; it is used in the USA by both Public (State, local, federal (FDA, USDA, CDC, DoD and EPA) and private laboratories for testing of foods & feeds, drugs, cosmetics, tobacco, natural products and cannabis (among other materials and products).
CIJ: How does laboratory accreditation benefit the cannabis testing laboratory?
Michelle: It provides a framework for continuous improvement and self-correction where the cannabis testing laboratory data management system is independently reviewed and blinded sample Proficiency Testing is encouraged.
CIJ: How does laboratory accreditation benefit the medical cannabis recommending physician?
Michelle: The physician gains a greater degree of assurance that the material provided by the dispensary is what the label says it is. This is especially important in working with patients that are immunocompromised where heavy metals, residual solvents and harmful pesticides could have negative health consequences.
CIJ: How does the testing of medical cannabis by an accredited laboratory benefit the patient?
Michelle: The patient gains increased confidence that the label accurately reflects the potency and chemical properties of the product.
CIJ: What specific challenges does A2LA face in accrediting cannabis testing laboratories?
Michelle: Much of the typical infrastructure is lacking or only now being developed. This ranges from proficiency testing programs, Reference Material Producers, method development and sampling procedures. There is also difficulty in ensuring that laboratories are appropriately validating methods in states where cannabis product is not yet available.
CIJ: Why is A2LA the optimal choice for ensuring the quality and reliability of the results produced by medical marijuana testing laboratories?
Michelle: A2LA has by far the most experience as an accreditor of laboratories that perform testing of natural plant products. We have been performing assessments of and granting accreditation to these types of laboratories for over twenty years. This results in our staff and our assessor corps who are then able to provide valuable insight and technical sophistication that other accreditation bodies do not have. Specific to the cannabis industry, A2LA is also represented in all the major standards development organizations, tradeshows and industry groups; which strengthens our understanding of the industry and ability to assist our customers towards meeting their goal of obtaining accreditation.
Last month, G3 Labs LLC, a Las Vegas-based cannabis-testing lab, had their license suspended for an unknown regulatory compliance issue. According to Stephanie Klapstein, spokeswoman for the Nevada Department of Taxation, the reason why their license was suspended is confidential. “We can’t disclose the details of the suspension, including anything about penalties,” says Klapstein.
When asked about the license suspension, Klapstein told us it was a compliance issue, but could not go into detail. “I can confirm that we did suspend G3’s license for compliance issues,” says Klapstein. “We are working with them to bring them back into compliance. In the meantime, they cannot operate.” Klapstein told the Las Vegas Review-Journal that the Nevada Department of Agriculture tested cannabis samples from the lab to determine if there was a need for a recall. She also confirmed with us that the compliance issue does not necessitate any product recalls.
According to the Las Vegas Review-Journal, this is the first time a cannabis business license is suspended in the state since the beginning of adult-use sales back in July of this year. Nevada’s cannabis regulations require independent lab testing of products before they reach shelves. That required testing includes checking for potency, microbials, pesticides, residual solvents, moisture content, growth regulators, Mycotoxins and foreign matter.
When we reached out to G3 Labs, they did not immediately respond to a request for comment.
Dr. Chao-Hsiung Tung, lab director at G3 Labs, told the Las Vegas Review-Journal that they couldn’t comment, based on advice from their legal counsel. “G3 Labs is actively sorting out the issues with the Department,” Dr. Tung told the Review-Journal in an email.
Currently, there are no lab testing regulations for Florida’s medical cannabis market. Chris Martinez, co-founder and chief operating officer of EVIO Labs Florida, a veteran-owned business, is looking to change that.
When Martinez co-founded EVIO Labs Florida, he saw the need for a dedicated cannabis lab to ensure safety and quality of medicine for patients in the state. Partnering with EVIO Labs to accomplish this goal, Martinez secured a 5,500 sq. ft. facility in Broward County to test for potency, pesticides, microbial contaminants, terpenes, residual solvents and heavy metals. Their lab, a first of its kind in the industry, qualifies as a true pharmaceutical-grade clean room. This week, Martinez also secured their 2nd laboratory location in the City of Gainsville, where they will test for potency, microbials, terpenes and residual solvents. And he isn’t doing it on the cheap. “Our Broward lab is powered by Shimadzu with over $1.2M in the latest testing equipment utilizing LCMS technology with the world’s fastest polarity switching time of 5 m/sec and scan speeds of 30,000 u/sec with UF Qarray sensitivity 90 times that of previously available technologies,” says Martinez.
Martinez, an entrepreneur at heart, started the lab with a team of experts to become the first completely cannabis-focused laboratory in Florida. Jorge Segredo, their head chemist and quality assurance director, has over 18 years of experience in the development of nutraceutical and pharmaceutical products under ISO and FDA accreditation. Segredo has helped launch three independent FDA-accredited laboratories and has extensive knowledge of HPLC, GCMS, LCMS, ICPMS technologies and development/validation of testing methods and procedures. Cynthia Brewer, their director of operations, was an active participant in the 2017 state legislative session and has been an advocate for medical cannabis, working with legislators on a suitable framework to increase patient access to cannabis.
EVIO is one of the nation’s leaders in cannabis testing, research science and advisory services. It is an evolving network of laboratories with nine EVIO cannabis laboratories operating in five different states: Oregon, Colorado, Massachusetts, Florida and California. “After speaking with industry chemists around the country for months, the EVIO name was constantly brought up in conversation,” says Martinez. “When we spoke with the EVIO Team it was an easy decision for us to partner.” He says Lori Glauser, chief operating officer of EVIO, and William Waldrop, chief executive officer of EVIO, are truly visionaries in the cannabis industry.
According to Martinez, their licensing agreement with EVIO Labs (OTC:SGBYD) marked a first for the publicly traded company with exclusivity in the Florida market. The agreement includes proprietary testing methodologies, operating procedures, training and support.
In addition to testing cannabis for safety and quality, they are launching a technology platform called MJ Buddy, essentially a software tool that takes efficacy feedback from patients and uses testing and genetic data they gather from EVIO Labs across the country. “This will provide real data to the cannabis industry as to the medical benefits for thousands of patients in relation to the genotype and cannabinoid profiles of their medicine,” says Martinez.
Of the states that have legalized some form of cannabis, a large number of them have some lab testing regulations on the book, with some more comprehensive than others. Martinez says he hopes the Florida Department of Health, Office of Medical Marijuana Use follows some of the more thorough state programs, such as Oregon. His team has compiled a set of documents for regulators with recommendations for regulating the lab testing industry.
Without any regulations on paper, it is up to businesses to produce safe and quality medicine, without any oversight. EVIO Labs Florida follows FDA Good Laboratory Practices, has an ISO 17025:2005 accreditation pending, and is working on TNI 2016 accreditation.
When discussing what he wants to see happen with Florida’s regulatory framework, Martinez says the rules need to be specific to Florida. For example, due to the climate being so humid, microbial contaminant testing for things like yeast and mold will be particularly imperative. Because processing methods like butane and alcohol extraction are legal, he emphasizes the need for comprehensive residual solvents testing. “The most important regulation would be to have the laboratories select the samples at the MMTC facility and have the state randomly verify laboratory results to ensure accurate unbiased testing,” says Martinez.
In addition to that, he hopes their pesticide thresholds will be realistic and based on actual science. “We believe the public should receive carcinogenic data for products that are inhaled,” says Martinez. “Chemicals may be introduced into the processing of cannabis to vape liquid that may cause harm. This is important information for public health and communication of the risk related to exposure to such materials.” Martinez says EVIO Labs Florida was founded on the belief that through technology and science we can increase safety and patient outcomes.
Emerald Scientific recently announced their proficiency-testing program, The Emerald Test, has been approved by Colorado as a third party provider for proficiency testing in licensed cannabis laboratories. The Emerald Test, held twice annually, is an inter-laboratory comparison and proficiency test (ILC-PT), allowing data to be collected pertaining to the performance of laboratories on a national scale. Proficiency testing is designed to measure how accurately laboratories perform and is a critical tool for quality assurance.
Colorado requires labs to participate in a proficiency-testing program in order to be certified to conduct required testing on cannabis and cannabis products for safety and quality. According to the press release, Colorado’s Marijuana Enforcement Division, under the Department of Revenue, conducted an evaluation process to determine which applicants could meet the performance standards for regulatory compliance concerning proficiency testing. The contract was awarded to Emerald Scientific following this evaluation process.
According to Ken Groggel, director of the Proficiency Testing Program at Emerald Scientific, a number of states have recognized the need for independent proficiency testing as a required piece of regulatory compliance. “The Emerald Test Inter-Laboratory Comparison/PT is state approved in Washington & Colorado for cannabis testing laboratory licensure,” says Groggel. “States with cannabis or hemp production, as well as labs in other countries are now actively participating in the Emerald Test as a tool for quality improvement, efficiency upgrades and product safety.” He says the Colorado Marijuana Enforcement Division has contracted with Emerald Scientific to provide third party PT programs for microbial contaminants, residual solvents and pesticides.
Beginning in 2014, The Emerald Test has been offered twice a year and, in 2017, over 50 labs participated from 14 states and 2 countries. “Laboratories that have enrolled more than once have seen significant improvement in their results, an indicator of improved performance for industry customers,” says Groggel.
Proficiency testing is important for ensuring quality, safety and product content accuracy. “This should be the priority whether you are a grower, manufacturer, testing laboratory, regulatory entity, medical patient or adult use consumer,” says Groggel. It also helps labs meet regulatory requirements and achieve ISO 17025 accreditation. “Independent proficiency testing helps determine if the lab is able to deliver the services marketed to its customers,” says Groggel. “Regulatory agencies can use this information when licensing, monitoring & enforcing good science for public safety.”
As new states legalize cannabis and develop consumer protection regulations, proficiency testing programs can help labs demonstrate their commitment to responsible and accurate testing. “When PT results show the cannabis testing lab is capable it is up to the government to ensure accountability for performance on behalf of all its citizens,” says Groggel. Labs can enroll starting on September 25th in the Fall 2017 Emerald Test ILC/PT.
This article continues the bill-by-bill review begun in the August 1st article on cannabis reform legislation proposed in the 115th Congress. In the next article and final piece in this series, we will examine the banking and tax reform bills related to cannabis.
Medical Cannabis Reform Bills
S. 1008 – Therapeutic Hemp Medical Act of 2017
HR. 2273 – Charlotte’s Web Medical Access Act of 2017
Policy: These bills would amend the CSA to end federal prohibition over all CBD products and all hemp plants with THC content levels of below 0.3%. In other words, people and businesses would be free to grow hemp and/or manufacture CBD products without any fear of federal prosecution. These products would most likely then fall under the regulation of other federal and/or state agencies, but the bills do not specify what agencies they might be or what controls might be put in place.
Impact: The impacts from these bills nationwide have the potential to be massive. Hemp is a plant that can be put to highly effective use in many different industries, from textiles and construction to foodstuffs and seafaring. The efficiency of its growth and the breadth of its utility will make it a highly valuable commodity and a competitor with many other raw materials. For state-legal cannabis businesses, the legalization of CBD and hemp at the federal level could fundamentally change the market for those products. States that legalized cannabis already have provisions in place dealing with hemp and CBD—sometimes alongside their cannabis laws, sometimes handled by a separate state agency—and they could either leave those as they are or open up those markets to interstate activity. In states that have not legalized, CBD and hemp are typically included in the state’s definition of cannabis, and therefore they will remain illegal under state law unless further action is taken. Most likely, if federal prohibition ends on hemp and CBD, state prohibition will follow suit. Because legalization at the federal level will allow for interstate commerce in hemp and CBD, expect the emergence of a nationwide market, driven by online sales and interstate marketing, and developing independently from a cannabis industry still constrained to in-state activities.
Introduced: May 2, 2017 by Senator Cory Gardner (R-CO)
Cosponsors: 7 Republican, 4 Democrat
Referred to Senate Committee on:
Introduced: May 1, 2017 by Representative Scott Perry (R-PA)
Cosponsors: 10 Republicans, 10 Democrats
Referred to House Committee on:
Subcommittee on Crime, Terrorism, Homeland Security, and Investigations
Energy and Commerce
Subcommittee on Health
S. 1276 – Cannabidiol Research Expansion Act
Policy: This bill would accomplish two objectives: First, it would open channels for researchers to access and experiment with cannabis and cannabis extracts. Second, it would initiate the process at the end of which the Attorney General must make a determination as to which Schedule of the CSA is most appropriate for cannabidiol (CBD).
Impact: The impact on this legislation to state-legal cannabis businesses is rather remote—in both time and practice. The research access provisions will certainly create an uptick in medical and psychological research activity, the outcomes of which will add to our knowledge of how consuming cannabis in different forms and amounts effects the brain and body. This type of government-regulated research takes many years to process and complete, as both bureaucratic and scientific standards must be met. As for initiating the re/de-scheduling review process for CBD, this is a direct response to the 2016 denial by the DEA to re/de-schedule cannabis. That determination, published in the Federal Registrar on August 12, 2016, was made following a comprehensive study of the medical benefits and harms of cannabis conducted by the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). Although such an in-depth study and its resulting negative determination pronounced so recently would normally rule out the chances of success for another re/de-scheduling attempt so soon after, the DEA did leave the door open with its statement that it “did not focus its evaluation on particular strains of marijuana or components or derivatives of marijuana.” It is just this door that S. 1276 seeks to exploit. By focusing the re/de-scheduling process on CBD specifically, the presumption is that the outcome of the scientific CBD studies would have a far better chance at satisfying the re/de-scheduling criteria set forth in the CSA. If such a determination was made, then the impact would come in two potential varieties. One, CBD would be rescheduled and become available for medical use according to FDA rules applicable to other prescription drugs. Two, CBD would be descheduled and would fall under the prerogative of the states, in which case the above analysis for S. 1008 and HR. 2273 would pertain.
Introduced: May 25, 2017 by Senator Dianne Feinstein (D-CA)
Cosponsors: 3 Republican, 2 Democrat
Referred to Senate Committee on:
S. 1374 – Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2017
HR. 2920 – Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2017
HR. 715 – Compassionate Access Act of 2017
HR. 714 – Legitimate Use of Medical Marijuana Act (LUMMA) of 2017
Policy: All four of these bills would make an exception to the CSA for state medical cannabis laws. Federal prohibition, in other words, would end for medical cannabis in those states that have legalized, and it would be left to those states to devise how it would be regulated. In states that have not legalized, both state and federal prohibition would remain. The companion CARERS Acts in the House and Senate, along with HR. 714, would also amend FDA rules to widen access to cannabis for research purposes.
Impact: The impact of these bills on the rules for state-legal medical cannabis businesses would be relatively minor in terms of functionality. This is so because they leave not only the determination to legalize up to the states, but they leave the design of the regulatory system up to the states as well. In other areas, however, big changes will be seen that benefit the industry: banking will open up for state medical businesses, and so will the opportunity to write-off ordinary business expenses. Investment risks over legality will end, making for easier access to capital. Questions about contract enforcement and risks of federal prosecution will become moot, and when state regulatory bodies make decisions on how to govern the industry, they will no longer have to concern themselves with U.S. DOJ enforcement and/or prosecutorial policies. Enactment of any of these bills would be a big win for medical cannabis.
Introduced: June 15, 2017 by Senator Cory Booker (D-NJ)
Referred to Senate Committee on:
Introduced: June 15, 2017 by Representative Steve Cohen (D-TN)
Cosponsors: 1 Republicans
Referred to House Committee on:
Subcommittee on Crime, Terrorism, Homeland Security, and Investigations
Energy and Commerce
Subcommittee on Health
Subcommittee on Health
Introduced: January 27, 2017 by Representative Morgan H. Griffith (R-VA)
Cosponsors: 2 Republicans, 1 Democrat
Referred to House Committee on:
Energy and Commerce
Subcommittee on Health
Subcommittee on Crime, Terrorism, Homeland Security, and Investigations
Introduced: January 27, 2017 by Representative Morgan H. Griffith
Cosponsors: 1 Democrat
Referred to House Committee on:
Energy and Commerce
Subcommittee on Health
HR. 2020 – To Provide for the Rescheduling of Marijuana into Schedule III of the CSA
Policy: As its wordy title indicates, this bill would bypass the schedule review process and by legislative fiat move cannabis from Schedule I to Schedule III of the CSA.
Impact: Businesses handling drugs in Schedule III must register with the DEA and comply with DEA record keeping and security requirements. Doctors would be permitted to prescribe cannabis products. Importing/exporting will become available by permit, which would bring state businesses into competition with foreign cannabis firms. The biggest impact will be that cannabis sold pursuant to federal law will have to undergo the FDA’s New Drug Application process conducted by the Center for Drug Evaluation and Research, the largest of the FDA’s five centers. This includes clinical testing and a comprehensive chemical/pharmacological review. The drug would then be subject to FDA regulation for marketing and labelling. For states that wanted to maintain their legal medical cannabis systems, a conflict would remain because cannabis cultivators and dispensaries could operate in compliance with state law while simultaneously failing to meet new FDA and DEA requirements. States will then have a choice: bring state laws into line with federal laws, creating all of the advantages of federal legality discussed above, yet causing major disruptions to the industry; or retain the status quo, allowing the industry to grow as is with all of the in-state advantages but without the advantages of federal legalization. This all would of course leave behind recreational cannabis which would remain in the legal gray zone.
Introduced: April 4, 2017 by Representative Matt Gaetz (R-FL)
Referred to House Committee on:
Energy and Commerce
Subcommittee on Health
HR. 331 – States’ Medical Marijuana Property Right Protection Act
Policy: Section 881(a)(7) of the CSA subjects to federal forfeiture all property involved with cannabis activities. This bill would make an exception to that provision for all property in compliance with state medical cannabis laws.
Impact: Although not legalizing medical cannabis, this bill would be a strong step in the direction of legitimizing state-legal medical cannabis businesses. As a result of the property forfeiture clause of the CSA, two impediments faced by the medical cannabis industry is that investors are hesitant to invest and land lords are hesitant to lease or otherwise engage the medical cannabis market. By eliminating the risk of such property loss due to the federal-state conflict, this bill would have the very welcomed impact of easing access to capital and expanding opportunities for land use.
Introduced: January31, 2017 by Representative Barbara Lee (D-CA)
Referred to the House Committee on:
Subcommittee on Crime, Terrorism, Homeland Security, and Investigations
The Craft Cannabis Alliance is a values-driven industry association whose mission is to define, promote, and celebrate authentic Oregon craft cannabis. Though it has only recently launched, it already counts many of Oregon’s most important local brands among its members, and looks poised to help lead a craft cannabis movement both within the industry and among consumers.
When recreational cannabis was originally legalized in Oregon,according to the Portland Mercury, there were residency requirements for obtaining a license, but in 2016 those rules were removed. In the wake of that decision, Adam J. Smith, founder and executive director of theCraft Cannabis Alliance, saw the prospect, and, increasingly, the reality of out-of-state businesses with deep pockets buying up local cannabis businesses, expanding out of state brands into the market, or financing new brands here. It was quickly apparent to Smith that the big money threatened to overwhelm the market, push Oregon-owned companies off of shelves and eventually dominate Oregon’s much-anticipated export market. In May, drawing on his experience as an organizer and drug policy reform advocate, as well as several years working in with Oregon craft industries, he launched the Craft Cannabis Alliance.
Smith has a long history of taking aim boldly at seemingly implacable interests. In 1998, Smith launched the Higher Education Act Reform Campaign (HEA Campaign), which successfully won back the right to federal financial aid for students with drug convictions. That campaign led to the founding ofStudents for Sensible Drug Policy, now the world’s largest student-led drug policy reform organization, active in more than 40 states and 26 countries. Since then, he has participated in a number of public policy and civic engagement campaigns and organizations, serving on the founding boards of the League of Young Voters and the Oregon Bus Project. He’s also written for dozens of publications on drug policy.
The Craft Cannabis Alliance is a membership-based industry association of cannabis businesses with like-minded values, who believe that cannabis is, in fact, Oregon’s next great craft industry. And they want to make sure that means something. We sat down with Smith to learn more about his organization and why he wants to fight big cannabis.
CannabisIndustryJournal: How exactly do you define craft cannabis?
Adam Smith: In the beer industry, the Brewers Association defines a craft producer as one who produces fewer than 6 million barrels per year, and is not more than 25% owned by a larger brewer. And that’s fine for beer, but with cannabis just emerging from its own prohibition, there are broader concerns that we believe a craft industry needs to be responsive to. So we’re less concerned with the size of a company’s production than how it’s producing that product, and how it’s contributing to communities and a healthy industry.
Here in Oregon, there’s a core of the cannabis industry that cares deeply about people, place, planet, and plant. As someone who has spent considerable time writing about and organizing around ending the drug war, it is important to me that cannabis’ first foray into the post-prohibitionist world is not only successful, but that it reflects a shared set of values. When I started talking with people in the industry who take their values seriously, I asked a lot of questions. I wanted to go from “we know it when we see it” to something that could be defined and therefore legitimately promoted. Pretty soon, it became clear that there were six major areas of agreement.
Ethical employment practices
Substantial local ownership
Meaningful participation in the movement to end the disastrous drug war.
The first three requirements, clean, sustainable, and ethical employment practices, are pretty obvious core values for craft producers, and we believe for many Oregon consumers as well.
Substantial local ownership, particularly in a place like Oregon, is an essential component of what the Alliance is trying to organize and represent. We grow some of the finest cannabis in the world in Oregon, and while we’re a small market, we know that eventually, probably sooner than most people realize, the federal walls will come down and we’ll be able to export our products to other states and internationally. At that point, Oregon will be home to a multi-billion dollar industry. The question then, is who will own that?
We are already seeing big out of state and international companies and investment groups buying up brands or starting their own brands here. With tens of millions of dollars behind them, they have the marketing and distribution muscle to push locally owned companies, even those producing superior product, off of shelves. And if foreign-owned companies are dominating shelf space here when those federal walls crumble, those are the companies that will own the export market, and who will ultimately own the Oregon Cannabis brand globally. And if that happens, we will never buy it back.
Southern Oregon, in particular, is a region that has seen little economic growth since the waning of the timber industry. The communities there have a huge stake in how this plays out. Will the cannabis industry build wealth, and economies, and institutions here? Or will Oregon become a low-wage factory for out of state and international corporations.
Beyond local ownership, community engagement is another important component of craft cannabis. The industry, which still faces PR challenges, many of them well earned, needs ambassadors who can demonstrate what a healthy cannabis industry looks like, and who will build the relationships and the credibility necessary to gain the loyal support of their neighbors, local media, and public officials.
Finally, participation in the anti-drug war movement, beyond the self interest of simply opening up the next market, is a must. This industry stands atop a mountain of eighty years of ruined lives and destroyed communities. If you are in the industry, and you are not looking for ways to support drug policy reform, you are profiteering, plain and simple. The drug war is teetering on the brink of the dustbin of history, but it is not over yet. The very existence of a legalized industry is the product of decades of work by many, many individuals, most of whom will never earn a dime from the end of prohibition, and never intended to. We view a healthy legal cannabis market as an important platform for social progress on this front, and we are going to use it.
CIJ: Doesn’t capitalism guarantee that the big money will win out? That striving to maintain one’s values in the face of competition that is laser-focused on profits above all else is inefficient and doomed to failure?
Adam: Believe me, when your name is Adam Smith, you spend a lot of time thinking about capitalism. Let’s be clear, our members are committed to profits. We just don’t believe that nihilism is going to be a profitable strategy in Oregon cannabis, nor should it be. Our goal is to monetize our values by offering a win-win proposition to consumers, opinion makers, political leaders, and everyone else who will benefit from a visionary, responsible, and successful Oregon industry feeding into the local economy.
The choice is not between capitalism and something else. It is between an extractive model of capitalism and a value-adding model of capitalism. Between an industry that seeks to bleed value from the earth, and communities, and employees, and consumers, and one that adds value to everything it touches at every level while producing the best cannabis in the world.
In the end, consumers are the key. If we can be the coolest thing happening in Oregon cannabis, if we can bring consumers into this movement, we will succeed. There’s simply no reason for Oregonians to be buying cannabis grown by a Canadian bank account, even if it’s physically produced here. That is SO not cool. And what’s cool in Oregon will be what’s cool and in demand nationally and internationally as we are able to expand the reach of the legal Oregon industry.
We believe that offering the world’s best cannabis, grown responsibly, by Oregonians who are actually committed to the environment, to their communities, and to social justice is a going to be a powerful marketing proposition here. More powerful than having a famous person on your label or weak attempts at greenwashing.
Within the authentic Oregon craft universe will be super high-end products, as well as more value-oriented offerings, and everything in between. We’re going to make it easy for Oregonians to recognize and support the kind of industry that we’d all like to see here.
CIJ: Why do you think this could be successful in Oregon? Is the industry receptive to this idea?
Adam: Not only the industry, but the media, elected officials, and most importantly, we believe, consumers.
Oregon sees itself, not unjustifiably, as the birthplace of the craft movement in America. Our craft beer, artisan wine, and craft distilling industries are world-class by any standard, and are very well supported locally. Include in that list our local food scene and the myriad artisans of all stripes who ply their trades in the region, and it’s pretty obvious that there will be strong support for a values-driven, locally owned cannabis industry.
Craft is about people making something they love, as well as they possibly can, for themselves and their friends, and to share with others who will love it too. It’s not a coincidence that those products tend also to be of the highest quality.
The key, as I’ve mentioned, is for craft cannabis is to build a partnership with consumers. Let them know who we are, and what we are trying to build, which is an authentic, and authentically Oregon craft cannabis movement.
There are quite a lot of people in the Oregon industry who share this vision, including many of the best and most important brands in the state. The are people who got into cannabis for the right reasons, with a craftsperson’s dedication to quality and mindfulness on all fronts. To truly be a craftsperson is not only to make an exceptional product, but also to be cognizant of the historical and social context of your craft, with a respect for what has come before, and a commitment to setting an example for those who will follow.
Those are our people, and they are well represented in the industry here. Our goal is to organize them and help insure a path to their success.
CIJ: Tell us about how you are educating the industry, consumers and political leaders.
Adam: Well, we launched at the end of May, from the stage at the Cultivation Classic, which highlights and honors the best cannabis in Oregon, grown sustainably and regeneratively. That was a great opportunity for us to introduce ourselves to the part of the industry that we’re targeting, and we were very grateful to Jeremy Plumb of Farma, who is also an Alliance member, and who puts on that incredible event, for that stage.
Right now, we are still a manageable group, size-wise, and we are doing a lot of personal networking in the industry, seeking out the right people to join us. It’s been a lot of “who do we like and trust, who is making great product?” As a long-time organizer, I believe in starting out by putting together the strongest possible group of leaders who are also good people and fun to work with. I’d say that that’s going very well, since we have just an incredible group, who I am honored to stand beside. Over the past several weeks, as we have started to be a bit outward facing, we have had more and more folks in the industry reaching out to us, rather than the other way around. So we’re in a great spot to grow.
On the political side, we really launched the project at the very end of the most recent state legislative session, and so we purposely did not engage that process this year. But over the past several months, we have been seeking out and introducing ourselves to key public officials. Their response has been extremely positive. Here we are, a group of companies who are substantially locally owned, and committed to being transparent and accountable to the health of our employees, our communities, and our state. In an industry that is still very chaotic, and not well organized, with plenty of shady players, I think that they see us as a compelling partner going forward.
CIJ: Some of these standards seem pretty difficult to quantify. How do you expect to judge new member businesses?
Adam: Well, in the areas of clean product, sustainable methods, and ethical employment practices, we will adopt standards being developed and promulgated by third-party certification efforts such as Resource Innovation Institute (energy, water, carbon footprint) and the Cannabis Certification Council (“organic” and fair labor standards). There are others as well, some that exist, things like Clean Green, and some that are still in development. We are beginning to meet with these folks to gauge where they are, and to give input on their standard-setting processes. In the end, hopefully within the next year as more third-party standards come online, we will choose which of those standards to adopt or accept.
Community engagement and anti-drug war participation will be things that we undertake as an alliance, as well as providing support for our members to do these things individually behind their brands
As for “substantial local ownership” we are already discussing the parameters of what that means. Certainly, here in Oregon, there is a need for outside capital. We are not going to fund a robust industry, especially one that is prepared to take advantage of the coming interstate and international markets, with all local funding.
That said, there is a huge difference between having an out of state partner who owns a piece of a local business, and having an out of state or international corporate overlord with a 90-100% ownership stake. And the distinction is important for the future of the industry and for Oregon’s economy.
The temptation is to set the bar at 50% in-state ownership. But what if you are a large cannabis brand, selling in four or five or six states, that is 35% or 40% Oregon-owned? That would likely meet the definition of “substantial.” It is a difficult line to draw, in some sense, but not impossible. As we move forward, we will develop guidelines on this, and we will have a membership committee that can look at an individual company and say “yes, you are substantially Oregon-owned” or “not you are not” as well as a process in place to insure fairness in that decision. Right now, every cannabis company in the Alliance is majority Oregon-owned, and I would expect that to continue except in very rare cases.
CIJ: One of your standards for membership requires participation in the movement to end the drug war. Some might see this as a given, but could you shed some light on this?
Adam: As I mentioned earlier, we see reform movement participation as a moral imperative, and since a lot of my background is in drug policy reform, it’s important to me personally. As an alliance, we hope to partner with organizations like Students for Sensible Drug Policy and NORML, and within the industry with groups like the Minority Cannabis Business Association to both advocate for broad drug policy reform, and hopefully to provide opportunities and support for communities that have been most negatively affected by Prohibition. We believe that those of us participating in the legal, regulated cannabis market have both a responsibility and an opportunity to use our voices to point out the difference between the chaos, corruption, and violence of prohibition, and the the sanity, humanity, and opportunity of a post-prohibitionist world.
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.
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.