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". 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 of 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
On October 27, 1970, the Controlled Substances Act (CSA) put into place five schedules or classifications of drugs that would be regulated in some fashion, and drugs were initially classified into those schedules, followed by annual reviews and updates. 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".
The CSA, in combination with the Reorganization Plan No. 2 of 1973 (which created the Drug Enforcement Administration (DEA)), meant the regulation and enforcement of the availability and use of controlled substances such as marijuana. However, decriminalization and legalization efforts of states over the past decades have brought federal regulation and enforcement conflicts to those states that have decriminalized and legalized marijuana, largely due to the federal government's insistence on maintaining marijuana as a Schedule I drug. Additional federal-level changes and rulings over the last decade have impacted federal regulation and enforcement of laws relating to cannabis. The following are major examples:
- October 19, 2009: The Ogden Memorandum: 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.
- June 29, 2011: The Cole Memorandum 1: A follow-up to the Ogden Memo, this memorandum muddied 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."
- August 29, 2013: The Cole Memorandum 2: 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—by 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.
- December 16, 2014 to current: Joyce Amendment: A tenuous truce of sorts arrived with the passage of the Rohrabacher-Farr (today known as Rohrabacher-Blumenauer) Amendment in December 2014. It 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. One of the downsides of the amendment is that it has essentially acted as a short-term rider attached to several spending bills since December 2014, causing worry among many when it came up for renewal, particularly during the era of Trump and then U.S. Attorney General Jeff Sessions. Yet he 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. In early 2018, 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 is good through the 2019 fiscal year, meaning Rohrabacher-Blumenauer could expire without issue in December.
- 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 set to vote and reconcile 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 1. As of early December, expectations are that Congress will reconcile and pass the bill with the industrial hemp text intact.
State and local regulation
As of December 2018, thirty-three U.S. states have put some sort of broad decriminalization or legalization laws for cannabis on the books. However, as previously noted, laws and regulations can very, sometimes significantly, among states. 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.
Standards part 11, and, in New York for example, the DEA. Beyond those base laboratory standards, 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."
Regardless, there remains at present a certain degree of inconsistency in test results from different labs, due for the most part to limited supply of good quality reference standards for QC and varying SOPs/methods. However, the trend is very much in the direction of required lab certifications to the same methods. The issue is compounded in that different methods of use (smoking, vaping, edibles, capsules, sublingual, topical, drinks) yield different delivered time-release and cumulative potencies, making recommended dosages somewhat problematic. However, the increased uniformity of laws and standards is leading to a general acknowledgment that the quality and consistency in the cannabis testing industry is quickly improving.
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 (current as of December 7, 2018)
- California State Regulations Title 16, Division 42 Bureau of Cannabis Control
- Leafly's State-by-State Guide to Cannabis Testing Regulations
- 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. 2018. https://cannabis.ca.gov/.
- CannaRegs and New Frontier (2017). "State-By-State Marijuana Policies". National Cannabis Industry Association (NCIA). http://thecannabisindustry.org/state-marijuana-policies-map. Retrieved 23 January 2017.
- 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.
- State of California (January 2019). "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 6 February 2019.
- Cole, T.; Trumble, S.; Hatalsky, L.E. (17 February 2016). "All State Marijuana Laws Are Not Created Equal". Third Way. http://www.thirdway.org/report/all-state-marijuana-laws-are-not-created-equal. Retrieved 02 February 2017.
- Beggan, P. (11 December 2018). "Canada Unveils New Cannabis Testing Standards For 2019". Ganjapreneur. https://www.ganjapreneur.com/canada-unveils-new-cannabis-testing-standards-for-2019. Retrieved 06 February 2019.
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- Ogden, D.W. (19 October 2009). "Memorandum for Selected United State Attorneys on Investigations and Prosecutions in States Authorizing the Medical Use of Marijuana". Justice Blogs. Department of Justice. https://www.justice.gov/opa/blog/memorandum-selected-united-state-attorneys-investigations-and-prosecutions-states. Retrieved 26 January 2017.
- Cambron, C.; Guttmannova, K.; Fleming, C.B. (2017). "State and National Contexts in Evaluating Cannabis Laws: A Case Study of Washington State". Journal of Drug Issues 47 (1): 74–90. doi:10.1177/0022042616678607.
- Cole, J.M. (29 June 2011). "Memorandum for United States Attorneys" (PDF). Department of Justice. https://www.justice.gov/sites/default/files/oip/legacy/2014/07/23/dag-guidance-2011-for-medical-marijuana-use.pdf. Retrieved 26 January 2017.
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- Cole, J.M. (29 August 2013). "Memorandum for All United States Attorneys" (PDF). Department of Justice. https://www.justice.gov/iso/opa/resources/3052013829132756857467.pdf. Retrieved 26 January 2017.
- "Federal Marijuana Enforcement Policy". Marijuana Policy Project. 2016. https://www.mpp.org/federal/federal-enforcement-policy-on-state-marijuana-laws/. Retrieved 26 January 2017.
- Armentano, P. (16 December 2014). "President Signs Federal Spending Bill Protecting State Sanctioned Medical Marijuana Programs". NORML Blog. NORML Foundation. http://blog.norml.org/2014/12/16/president-to-sign-federal-spending-bill-protecting-state-sanctioned-medical-marijuana-programs/. Retrieved 27 January 2017.
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