Regulatory Compliance - Cannabis
Federal and state regulation
Like the state of California has done with its various state agencies, other states that have legalized cannabis for medical use, adult consumption or both have also established government agencies or departments to oversee cannabis regulation or assigned those responsibilities to existing agencies. For instance, with the voters in Massachusetts having approved adult recreational use in November 2016, the state created a new agency called the Cannabis Control Commission. Back in 2013, Washington State charged its Liquor Control Board with developing a plan for regulating cannabis testing labs. There are also various validation consultants and companies who have begun to specialize in this industry. And of course the big news is that California finally updated and passed its temporary measures into law in January 2019, with California Code of Regulations Title 16, Division 42, Bureau of Cannabis Control, with Chapter 6 the relevant section for laboratories. The vagaries of its initial regulations have been honed into specifics regarding required testing, even regarding methods, thresholds, limits and how the COA needs to look.
However, despite strong state-specific efforts, regulations still vary from state to state and in Canada and Uruguay. In 2017, it was suggested that, to bring about more consistency, it may require the federal government "to set up policy guardrails to steer state regulatory systems" in a more unified and safe direction. Additionally, the unified efforts of standards organizations and professional associations may also help to bring even more consistency to testing. However, the advent of California's detailed guidance, along with Canada's (more relaxed and public health system-oriented) controls and those of other states, finds states or countries contemplating legalization in 2019 with a much better understanding and selection of paradigms on which to model their own regulations.
In the case of Canada, the previous testing requirements and standards for medical cannabis were joined by a new set of pesticide testing requirements for recreational and medical cannabis in 2019.
Much of what follows comes directly from Chapter 2 of Past, Present, and Future of Cannabis Laboratory Testing and Regulation in the United States on LIMSwiki.
Federal regulation of cannabis Marijuana was initially placed under Schedule I and remains there today. As a Schedule I drug, the federal government is indicating marijuana has:
- "a high potential for abuse";
- "no currently accepted medical use in treatment in the United States"; and
- "a lack of accepted safety for use of the drug or other substance under medical supervision".
Then came the Reorganization Plan No. 2 of 1973, which took existing enforcement entities such as the Bureau of Narcotics and Dangerous Drugs and placed them into a new, unified entity called the Drug Enforcement Administration (DEA). Then President Richard Nixon said of the transition:
The enforcement work could benefit significantly, however, from consolidation of our anti-drug forces under a single unified command. Right now the Federal Government is fighting the war on drug abuse under a distinct handicap, for its efforts are those of a loosely confederated alliance facing a resourceful, elusive, worldwide enemy.
The DEA was given numerous responsibilities, including but not limited to the development of enforcement strategy; investigation and prosecution preparation of suspects violating federal law; regulation of drugs and other controlled substances; and coordination and cooperation with state and local government drug enforcement efforts. Since then the DEA has taken various steps—with guidance from the Food and Drug Administration (FDA)—to regulate and enforce the availability and use of controlled substances such as marijuana. As the decriminalization and legalization efforts of states have increased in past decades, this has brought federal regulation and enforcement conflicts to those states that have decriminalized and legalized, largely due to the federal government's insistence on maintaining marijuana as a Schedule I drug.
Numerous changes in policy and controversies have occurred since the Controlled Substance Act and DEA were implemented, including a 22-year-long effort by the National Organization for the Reform of Marijuana Laws (NORML) to have marijuana rescheduled (1972–1994). However, the following talking points represent the most recent important federal-level changes and rulings that impact federal regulation of and enforcement of laws relating to cannabis.
October 19, 2009: The Ogden Memorandum
Deputy Attorney General David W. Ogden issued a memorandum "intended solely as a guide to the exercise of investigative and prosecutorial discretion" in regards to state-based laws allowing medical cannabis. The guidance essentially told U.S. attorneys to not prosecute those entities complying fully with state cannabis laws. Researchers generally agree that this memo acted "as a catalyst for expansion of [state-sanctioned and gray market] cannabis supply in states with poorly defined regulations," though the degree to which it influenced such growth remains poorly documented and requires further investigation. To be sure, it likely had some effect, as the number of licensed patients using medical marijuana in the state of Colorado increased from 4,800 in 2008 to 41,000 in 2009, and operating dispensaries jumped to more than 900 by mid-2010.
June 29, 2011: The Cole Memorandum 1
Deputy Attorney General James M. Cole issued a memo as a follow-up to the Ogden Memo, muddying the waters in the process. While stating that the stance of efficiently using department resources as outlined in the Ogden Memo still stood, Cole also made it clear that large grow-ops that didn't qualify as "caregivers" had sprung up since. The language of the memo essentially said "get off your butts and nail those suckers." Cambron et al. and Fairman suggest this memo had some impact as evidenced by declines in cannabis patient registration from 2011–2013 in Colorado, Michigan, and Montana.
August 29, 2013: The Cole Memorandum 2
Deputy Attorney General James M. Cole issued a follow-up memo to his original two years later, following 1. on the heels of then President Obama reiterating publicly that the Department of Justice (DoJ) was to not focus unnecessarily on states that had passed legalization laws and 2. Washington and Colorado legalizing recreational use of cannabis. The second memorandum sought to reduce the emphasis on the size of the grow-op and increase emphasis on—using a case-by-case basis—"whether the operation is demonstrably in compliance with a strong and effective state regulatory system." The memo also clarified specific cases where federal enforcement would be warranted, including distribution to minors, interstate transport, and preventing drugged driving (though it didn't state how). Generally speaking, states saw little federal intervention except in the case of state law being broken or requiring dispensaries to move further away from schools. Despite the memo, some attorneys continued to see Cole Memorandum 2 as nothing more than unclear language that had no legal weight for anxious growers and distributors in states where cannabis was legalized.
December 16, 2014 to current: Joyce Amendment
A tenuous truce of sorts arrived with the passage of the Rohrabacher-Farr (later Rohrabacher-Blumenauer, today Joyce) Amendment in December 2014. The amendment prohibited the DoJ from spending funds to prevent or enforce against state laws that allow for medical marijuana cultivation, distribution, and use, particularly when those actions are performed consistently with those state laws. Before being passed in December 2014, the amendment had actually been introduced and defeated six times in the previous 10 years. The DoJ later went on to challenge the amendment on several occasions, from U.S. v. Marin Alliance for Medical Marijuana in 2015 to a collection of 10 different cases from California and Washington in 2016. In all these instances, the courts ruled against the DoJ, setting precedent against further department action.
One of the downsides of Rohrabacher-Farr is that it has essentially acted as a short-term rider attached to several spending bills since December 2014. Due again for renewal in April 2017, and with the new Trump administration coalescing—including Trump's demonstrably anti-drug U.S. Attorney General Jeff Sessions—some in the industry were concerned the amendment would not be renewed, opening the door again for the DoJ to implement stronger enforcement. However, the Amendment continued to live on as the Rohrabacher-Blumenauer Amendment, with Rep. Earl Blumenauer taking over as co-lead with the retirement of Rep. Farr. Alternative bills had continued to be proposed in the meantime, including a more permanent version of Rohrabacher-Blumenauer introduced by Representative Dana Rohrabacher of California; however, Speaker Paul Ryan implemented rules prohibiting amendments to budgetary legislation, and the fact remained that Congress was still reluctant in hearing bills that would change the country's marijuana laws.
The Rohrabacher-Blumenauer amendment was renewed through December 8, 2018 However, earlier in the year, Rep. David Joyce submitted an amendment to protect against federal intrusions on medical marijuana patients abiding by state cannabis laws. Passing in May 2018 and acting the same as Rohrabacher-Blumenauer, the new Joyce Amendment was good through the 2019 fiscal year. However, vows by President Trump in late 2018 to shut down the government "for border security" left some to wonder if a shutdown would affect the continuity of the Joyce Amendment. In June 2019, a modified version of Rohrabacher-Blumenauer by Blumenauer-McClintock-Norton was approved by the U.S. House, which added on protections for adult-use cannabis users as well as medical cannabis users. It was attached to a large-scale appropriations bill, but the broader version was removed last-minute, leaving only the original protections for medical cannabis. However, it's not clear if the original Rohrabacher-Blumenauer will be approved under the 2021 federal budget plan, as President Trump has reportedly pushed back against its inclusion.
August 11, 2016: DEA denies petition to reschedule marijuana out of Schedule I
A request made by two governors and a psychiatric nurse practitioner to the DEA asking it to reschedule marijuana into any other schedule other than Schedule I was denied, as had been done with previous attempts in 2009 and 2011. Reasons included known health issues such as prenatal exposure and negative impacts on several biological systems, as well as limited research data and new drug applications. At the same time, however, the DEA also recognized the need for further research and the lack of legal marijuana sources for researchers, publishing a policy statement stating intent "to increase the lawful supply of marijuana available to researchers." However, that statement of intent has not been acted upon as of December 2018.
December 2018: Congress votes to reconcile and approve the 2018 Farm Bill
In April 2018, Majority Leader Mitch McConnell introduced the Hemp Farming Act of 2018, which later found its way into the 2018 Farm Bill. On November 29, lawmakers "struck a deal in principle" to finalize the 2018 Farm Bill, which, if passed, would remove industrial hemp from the Controlled Substance Act's definition of "marijuana" as well as strike it from Schedule I. On December 20, 2018, President Trump signed the Farm Bill into law, legalizing the cultivation and sale of hemp at the federal level. With this, expectations were that this would represent a logical next step that will eventually see the U.S. government take further action to legalize derivative products and even cannabis. However, despite hemp legalization, legal experts such as those at The National Law Review note additional problems arising, particularly in the realm of cannabidiol (CBD) derived from industrial hemp. Citing a "schizophrenic" state of law across federal and state governments and agencies regarding the status of CBD, expectations are such that the FDA may step up enforcement of CBD infractions, and civil suits against manufacturers who make unjust medical claims about CBD-infused products may rise in number. In fact, some of the first significant warnings were made by the FDA in November 2019, sending warning letters to 15 companies for violating terms of the Federal Food, Drug, and Cosmetic Act, as well as violating marketing and formulation regulations.
January 15, 2020: House Committee on Energy and Commerce, Health Subcommittee holds first ever cannabis-related hearing
The House Health Subcommittee of the House Committee on Energy and Commerce has held its first ever cannabis hearing, titled "Cannabis Policies for the New Decade." Though no votes or updates to legislation came out of the hearing, much debate over existing and future legislation took place. The primary focus of the hearing was the discussion surrounding cannabis research and cannabis' current scheduling, as well as the problems that come from it. While the committee members agreed that more government-authorized cannabis farms for research materials, as well as more researchers, were needed, there was much disagreement about how to go about with either rescheduling or descheduling cannabis. Bills in various stages of process were discussed, including H.R. 171 on rescheduling THC-containing cannabis to Schedule II, H.R. 601 on producing more research-grade cannabis, and H.R. 2843 on removing cannabis from scheduling, though with numerous stipulations. While nothing specific was resolved, Subcommittee Chairwoman Anna Eshoo reportedly indicated that future hearings would be held, which may include non-agency stakeholders.
December 4, 2020: The MORE Act is approved by the House
As proposed, the Marijuana Opportunity Reinvestment and Expungement (MORE) Act, introduced by Representatives Nydia M. Velázquez and Jared Golden, "decriminalizes marijuana at the federal level while enabling states to set their regulatory policies without the threat of federal intervention." (It also contains provisions to "make it easier for cannabis businesses legal under state laws to get help from" the Small Business Administration (SBA).) The House voted to pass the legislation in early December 2020, but it was expected to go nowhere in the Senate later that month. With changes in the makeup of the Senate in January 2021, a reasonable chance exists that the MORE Act, or a modified version of it, could work its way through the Congress.
State and local regulation
As of January 2021, thirty-seven U.S. states and the District of Columbia have put some sort of broad decriminalization or legalization laws for cannabis on the books. In October 1973, Oregon became the first state to enact decriminalization laws for marijuana, imposing a $100 fine for possession of less than an ounce. Eleven other states followed a similar path within five years. The next wave of changes began with the passage of medical marijuana legislation in California—the Compassionate Use Act—in November 1996, followed by similar legislation in Oregon and Alaska in 1998, Maine in 1999, and Colorado, Hawaii, and Nevada in 2000. Other states continued to add decriminalization and medical marijuana laws in the 2000s. But it wasn't until 2012 that Colorado and Washington became the first states to make recreational marijuana legal, followed by Alaska, Oregon, and the District of Columbia in 2014. Colorado, Maine, Massachusetts, and Nevada followed suit in 2016, with Michigan doing the same in 2018.
As shown by Cambron et al. in 2016 (before the November election results), dispensaries, possession limits, and interstate ID card acceptance can vary significantly among affected states. California, Colorado, Michigan, Oregon, and Washington lead in number of dispensaries; Massachusetts, Oregon, and Washington in maximum possession limits; and Arizona plus five others allowed ID cards from other states. Yet allowed dispensaries can number in the single digits, possession limits can be as low as one ounce, and numerous states still don't honor ID cards from other states.
Then there's the matter of state differences in testing, enforcement, advertising allowances, etc. It helps to turn to professional associations and organizations—who often lead the charge for improved, more relevant standards—to sort through the variances. The Association of Public Health Laboratories (APHL), for example, has published its Guidance for State Medical Cannabis Testing Programs to help sort through the confusing tangle of existing testing laws, where they exist. They exemplify this variation of law in their document:
As with most programs in the United States, every state takes a different approach. For example as of January 2016, New Jersey’s Public Health & Environmental Laboratories only test cannabis plant material. Just across the Hudson, however, New York’s Public Health Laboratory will not be testing any plant material, only cannabis extracts. In addition, the New York Department of Health will provide an oversight role for commercial cannabis laboratories that are licensed by the federal Drug Enforcement Administration (DEA) and approved for testing cannabis products. On the other hand, New Jersey state government does all testing in-house for the medical cannabis program.
As such, unlike their federal counterpart, it's difficult to make broad generalizations about cannabis regulations and their enforcement in the states. It becomes even more difficult when examining states that don't have clear, well-considered regulations or strong enforcement powers. Cambron et al. emphasized this issue in regards to the supply side, saying: "States without clearly defined regulations for medical cannabis supply have fostered gray markets for cannabis whereby individuals without documented medical conditions are able to easily obtain medical cannabis authorizations. This scenario has created substantial challenges for law enforcement in multiple states."
Cole et al. argue that in the end, it will take pressure on the federal government "to set up policy guardrails to steer state regulatory systems" in a more unified and safe direction. Drugged driving, use by minors, interstate distribution, relation to crime and firearms, consumer safety, and advertising are all issues the government should be tackling towards that goal, they say. Not that states aren't addressing these regulatory concerns; they are, but not in consistent ways.
While federal, state, and local governments wrestle with the regulatory frameworks surrounding cannabis, scientists and government officials are carrying on, doing what they can to harmonize those regulations with emerging industry standards and guidelines. For example, state officials from Colorado, New Mexico, Oregon, and Washington teamed up to give a presentation called "State Regulatory Approaches to Cannabis Testing, Operations and Product Logistics" at the July 2016 Cannabis Quality, Strategies and Solutions Summit. That presentation focused on the harmonization of regulatory standards and frameworks across states, as well as discussions of what scientific efforts are required to support those standards and frameworks. Additionally, organizations such as Americans for Safe Access Foundation (ASAF), American Herbal Pharmacopoeia (AHP), American Herbal Products Association (AHPA), Association of Official Agricultural Chemists (AOAC), and the American Oil Chemists' Society (AOCS) have been developing standards, methods, and certifications for analysis, extraction, labeling, and laboratory operations surrounding medical (and recreational) marijuana.
Notable among those organizations is the Foundation of Cannabis Unified Standards (FOCUS), which worked to produce internationally applicable voluntary consensus standards for various parts of the cannabis business chain, including cultivation, extraction, laboratory testing, and packaging. FOCUS completed its public review process and finalized its standards in July 2016, though at that time it wasn't clear how to gain access to them. New information came to light in March 2017, when FOCUS and ASTM International announced a collaboration between the two entities, which in April 2017 saw the formation of volunteer committee D37 at ASTM and the further adaptation of FOCUS' standards to future ASTM releases.
- indoor and outdoor horticulture and agriculture: e.g., pest management, water considerations, environmental site assessment, and sustainability
- quality management systems: e.g., quality considerations, due diligence
- laboratory testing: e.g., sampling, stability testing, purity testing, analytical methods, and proficiency testing
- processing and handling: e.g., drying and curing, exposure management, waste management, storage
- security and transportation: e.g., packaging, shipping management, risk assessment and mitigation, occupational health and safety
- training, assessment, and credentialing: e.g., laboratory training, clean room management, quality inspection, patient and physician education
Since its founding in April 2017, Committee D37 has made strides towards its goals. Meeting every January and June, D37 has made progress on developing several standards and creating a set of standardized terminology to be used across them. Its first two approved standards arrived in May 2018, concerning testing methods for determining water activity in cannabis samples, as well as the range of water activity that is "safe and effective" for storing samples. In August 2018, the committee announced a new standards project that would result in two guides that "will provide sampling procedures critical in generating accurate laboratory results, which in turn could lead to improved consumer safety." By October 2018, ASTM Committee D37 had agreed to work with the International Cannabis and Cannabinoids Institute (ICCI) to mutually develop standards for the cannabis industry. Since then a variety of other standards have been developed through the cooperative agreement, with more standards in the preparation phase, including standards for determining cannabinoid concentrations, residual solvents, and pesticide amounts.
In addition to ASTM's Committee D37, the AOAC and its Cannabis Analytical Science Program (CASP) has also been recently active in developing standards for cannabis laboratory testing. In August 2018, the AOAC's CASP finalized its first "Standard Method Performance Requirement" or "SMPR," which is a set of "minimum recommended performance characteristics to be used during the evaluation of a method." Within the AOAC, they're also used for the "evaluation of validation study data for method[s] being considered for Performance Tested Methods or AOAC Official Methods of Analysis." The first SMPR addressed identifying and quantifying pesticides in dried cannabis materials. In September 2019, they approved an SMPR for analyzing cannabinoids in hemp (i.e., low THC cannabis varieties). This was followed up a month later by the release of an SMPR for determining residual solvents in cannabis derivatives, as well as one for detecting the Aspergillus fungus in cannabis. The USDA has reportedly adopted the AOAC's cannabinoid testing standard as part of its Domestic Hemp Production Program, further cementing the standard into more common use. The CASP has set a goal to develop and adopt an additional six cannabis- or hemp-based SMPRs, as well as several official methods, by the end of 2020.
There are a couple of resources that help provide guidance on where to go to see the various laws that do exist regarding cannabis generally and testing specifically:
- Fox Rothschild's National Survey on Marijuana Laws and Regulations
- California State Regulations Title 16, Division 42 Bureau of Cannabis Control
- Leafly's "Cannabis testing regulations: A state-by-state guide"
- National Conference of State Legislatures' "State Medical Marijuana Laws"
- ProCon.org's Legal Medical Marijuana States and DC
- ProCon.org's "Legal Recreational Marijuana States and DC"
- Washington State I-502 "Testing Facility Criteria"
- Canada Cannabis Testing Regulations
Beyond that, accessing the specific government websites will lead to the applicable regulatory information in most cases.
- "California Cannabis Portal". State of California. https://cannabis.ca.gov/. Retrieved 08 January 2021.
- Cannabis Control Commission. "About the Commission". Commonwealth of Massachusetts. https://mass-cannabis-control.com/about-us-2/. Retrieved 08 January 2021.
- Anderson, W.H. (26 August 2013). "Cannabis Testing Labs: Standards and Accreditation". Washington State Liquor Control Board. https://lcb.wa.gov/publications/Marijuana/BOTEC%20reports/2b_Accrediting_Labs_Final_10_15_13.pdf. Retrieved 08 January 2021.
- State of California. "California Code of Regulations Title 16. Professional and Vocational Regulations Division 42. Bureau of Cannabis Control". Thomson Reuters Westlaw. https://govt.westlaw.com/calregs/Browse/Home/California/CaliforniaCodeofRegulations?guid=I57220DEBD2E54B1BB1EC67A6467E2F2E&originationContext=documenttoc&transitionType=Default&contextData=(sc.Default). Retrieved 08 January 2021.
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