LII:Past, Present, and Future of Cannabis Laboratory Testing and Regulation in the United States/Regulation, standardization, and quality

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Now that we have a bit of background on the cannabis industry, the next logical step is to look more closely at the regulations and standards that shape it. This chapter looks at the federal, state, and local regulations and the slowly evolving standardization process for laboratory testing of cannabis in the U.S.


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2. Regulation, standardization, and quality

2.1 Federal regulation of cannabis

Dea color logo.svg

On October 27, 1970, the Controlled Substances Act 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.[1] Marijuana was initially placed under Schedule I[1] and remains there today.[2][3][4] As a Schedule I drug, the federal government is indicating marijuana has[1]:

  • "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).[5][6] Then President Richard Nixon said of the transition[5]:

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.[5] Since then, the DEA has taken various steps—with guidance from the Food and Drug Administration (FDA)[7]—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.[8][9]

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).[10] However, the following talking points represent the most recent important federal-level changes and rulings that have impacted federal regulation 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.[11] 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.[12] 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.[13]

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.[14] The language of the memo essentially said "get off your butts and nail those suckers."[15] Cambron et al.[12] and Fairman[16] 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

Two years later, Deputy Attorney General James M. Cole issued a follow-up memo to his original, 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.[12] 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."[17] 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.[18][12] 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.[15]

December 16, 2014 to current: Lee-Joyce Amendment

A tenuous truce of sorts arrived with the passage of the Rohrabacher-Farr (later Rohrabacher-Blumenauer, Joyce, and today Lee-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.[19] Before being passed in December 2014, the amendment had actually been introduced and defeated six times in the previous 10 years.[20] 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.[21][22]

One of the downsides of Rohrabacher-Farr is that it 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.[23][24][25][26][27] 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.[28][29]

The Rohrabacher-Blumenauer amendment was renewed through December 8, 2018[30] 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.[31] However, vows by President Trump in late 2018 to shut down the government "for border security"[32] left some to wonder if a shutdown would affect the continuity of the Joyce Amendment.[33] 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.[34] It was attached to a large-scale appropriations bill[35][36], but the broader version was removed last-minute, leaving only the original protections for medical cannabis.[37]

In June 2022, another take on Rohrabacher-Blumenauer, the Lee-Joyce Amendment, passed through the House Appropriations Committee as part of a budget rider for 2023 Commerce, Justice, Science and Related Agencies. Like prior iterations, it would prohibit the DoJ from using federal funds to interfere with state authority and act against adults using cannabis in compliance with state, tribal, or territorial law, though this version covers both medical and recreational cannabis.[38] Of course, Lee-Joyce still ultimately needs to make it through Senate scrutiny in 2022/2023.

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.[2][3][4] 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.[8] 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."[39]

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.[40][41][42] On December 20, 2018, President Trump signed the Farm Bill into law, legalizing the cultivation and sale of hemp at the federal level.[43] 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.[41] However, despite hemp legalization, legal experts such as those at The National Law Review noted the potential for additional problems to arise, 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 were 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.[42] 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.[44]

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.[45]

December 4, 2020 to current: MORE Act

In 2020, Representatives Nydia M. Velázquez and Jared Golden introduced the Marijuana Opportunity Reinvestment and Expungement (MORE) Act, which would decriminalize "marijuana at the federal level while enabling states to set their regulatory policies without the threat of federal intervention."[46] (It also contained provisions to "make it easier for cannabis businesses legal under state laws to get help from" the Small Business Administration (SBA).[47][48][49]) The House voted to pass the legislation in early December 2020, but it was expected to go nowhere in the Senate later that month.[50] Expections were, however, that With changes in the makeup of the Senate in January 2021, a reasonable chance would exist that the MORE Act, or a modified version of it, could work its way through the Congress.[51] It again received support from the House Judiciary Committee in September 2021[52] and in April 2022.[53] As of July 2022, MORE is still in the hands of the Senate Committee on Finance, and it's not clear what happens next.[54]

An alternative to the MORE Act—H.R.3105 - Common Sense Cannabis Reform for Veterans, Small Businesses, and Medical Professionals Act—was introduced in 2021, but it remains in the House Subcommittee on Crime, Terrorism, and Homeland Security as of July 2022.[55][56]

2021 to current: CAOA Act

At the beginning of 2021, Democratic senators Schumer, Wyden, and Booker made an informal proposal concerning cannabis reform, culminating in a July 2021 discussion draft of what was called the Cannabis Administration and Opportunity Act (CAOA). As described, CAOA would remove cannabis from the Controlled Substance Act, embrace state cannabis laws, make the FDA the lead regulator, expunge/resentence unjust convictions, guarantee Federal benefits for cannabis users, and more.[57][58] CAOA is expected to be formally introduced at some point in the summer of 2022.[59]


2.2 State and local regulation

Note: It would be beyond the scope of this guide to include every state's laws and guidelines on cannabis testing and consumption; entities such as Leafly Holdings[60] and NORML[61] provide such online resources.

As of July 2022, thirty-eight U.S. states and the District of Columbia (D.C.) have approved broad legalization of medicinal marijuana, with 19 U.S. states and D.C. also approving recreational marijuana.[62] 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.[63] 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.[12][64] 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.[12] Colorado, Maine, Massachusetts, and Nevada followed suit in 2016[65], with Michigan doing the same in 2018.[66]

As shown by Cambron et al. in 2016 (before the November election results)[12], dispensaries, possession limits, and interstate ID card acceptance can vary significantly among affected states. California, Colorado, Michigan, Oregon, and Washington led 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 numbered in the single digits, possession limits were as low as one ounce, and numerous states still didn't honor ID cards from other states.[12]

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. In 2016, the Association of Public Health Laboratories (APHL), for example, published its Guidance for State Medical Cannabis Testing Programs to help sort through the confusing tangle of existing testing laws, where they exist. They highlight this variation of law in their guidance document[67]:

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."[12]

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.[68][69]


2.3 Standardization and harmonization efforts

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 the patchwork of 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.[70] 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.[71][72][73][74][75][76] As MJBizDaily contributor Omar Sacirbey notes[77]:

Having consistent testing methods is an important step for marijuana executives, because it will help harmonize standards that, so far, vary greatly from state to state. Those inconsistencies and the lack of defined testing methods raise the risk of errors and product recalls for businesses. Standardized testing methods can reduce those risks and give new and existing labs proven and certified procedures to refer to, sparing them the time and cost of developing their own methods.

More 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.[78] 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.[79][80]

The newly formed Committee D37 agreed to pursue cannabis standardization in six key areas[81][82]:

  • 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[80], D37 has made progress on developing several standards and creating a set of standardized terminology to be used across them.[83] 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.[84] 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."[85] 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.[86] Since then, a variety of other standards have been developed through the cooperative agreement, including standards for analytical laboratory operations, laboratory test method development and validation, stability testing, and sampling.[87]

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.[88] In September 2019, they approved an SMPR (2019.003) 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.[89] (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.[89]) The AOAC has also worked to get additional analytical methods published in academic journals, including one for "Determination of Cannabinoids in Cannabis sativa Dried Flowers and Oils by LC-UV"[90] and another for "Quantitation of Cannabinoids in Cannabis Dried Plant Materials, Concentrates, and Oils Using Liquid Chromatography-Diode Array Detection Technique with Optional Mass Spectrometric Detection."[91] And the CASP 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.[92] As of July 2022, thirteen SMPRs for cannabis have been released, with two additional ones concerning heavy metal and cannabinoid quantitation in beverage in draft status.[93]

Also of note is the National Institute of Standards and Technology (NIST) Cannabis Quality Assurance Program (CannaQAP). Launched in July 2020, the CannaQAP "aims to increase accuracy in product labeling and help forensic laboratories distinguish between hemp, which is legal in all states, and marijuana, which is not."[94][95] Similar in vein to The Emerald Test[96], NIST uses a proficiency test approach, though without the pass-fail grade, allowing participating labs to improve their analytical methods based off the most successful methods.[94][95] It's possible efforts like these will further lead to more standardized approaches to testing cannabis constituents and contaminants.

Finally, the Cannabis Regulators Association (CANNRA) is another recent non-profit entity working to harmonize regulations and standards across the industry. Formed in November 2020, CANNRA was "created in order to assist federal, state, and local jurisdictions that have approved or are weighing legalization of cannabis" and "engage with each other to identify and develop best practices, create model policies that safeguard public health and safety, and promote regulatory certainty for industry participants."[97] Since its creation, regulators from more than 40 states, jurisdictions, and territories have eventually joined "to foster harmony and, where possible, standardization across jurisdictions that legalize and regulate cannabis."[77][98] The organization has not only highlighted regulatory issues such as lack of standardization of laboratory testing across U.S. states[99], but it also has submitted responses to draft legislation requests for comments and written letters to government officials encouraging stances on matters related to the industry[100] (though the association notes that it's "not a cannabis advocacy group"[99]).

2.3.1. Enforcement

While this harmonization of regulations, standards, and accreditation requirements is a worthy effort, downstream enforcement efforts will eventually need to be just as durable to ensure harmonization efforts aren't for not.[77] The importance of enforcement is expressed in a June 2022 "Notice of Proposed Rulemaking" by the Department of Cannabis Control (DCC) of California. The proposed rules would standardize lab testing methods across the entire state "so there is greater integrity in the market, accurate information for consumers, and confidence among stakeholders."[101] The DCC says this of enforcement of the proposed test method requirements[102]:

A well organized, clearly written set of procedures will allow the Department to better educate [laboratory] licensees regarding the testing method as well as provide consistency in enforcement. Effective education and enforcement regarding the requirements found in the regulations are essential to the Department’s goal of ensuring that California’s licensed laboratories operate in a manner that benefits the state of California while reducing or eliminating the risks of harm to the people of the state. The increased clarity and efficiency obtained by the proposed regulation will further increase the Department’s ability to carry out this mission.

This focus on enforcement is noteworthy in light of their announcement and request for comments, noting that "[t]he regulatory package comes on the heels of concerns about cannabis potency inflation and 'laboratory shopping,' by cannabis businesses looking to secure THC levels that may be higher than what is actually contained in the cannabis flower or product."[101] This issue of laboratory shopping and labs bending the rules to gain more clientele is not isolated to California, as other states like Washington and Alaska have also experienced such issues.[77][103][104][105][106] As such, consistency in laboratory testing through harmonized methods will also require a similarly "harmonized" consistency in enforcing the use of those methods. As Straight Line Analytics founder James MacRae notes, "You put consequences on the labs, and you start assessing ... This is something that can be done fairly inexpensively and involves random off-the-shelf testing."[77]


2.4 Quality

Water quality testing in the lab (6f16fede-a75c-4444-af64-a339dff12012).JPG

Much has already been said about regulations, standards, and any associated enforcement action. We've learned that cannabis testing labs increasingly find themselves needing to not only meet a wide array of regulations but, as the industry matures, also adhering to more rigorous, standardized test methods. Adhering to these regulations and standards helps ensure the lab's long-term viability, the safety of cannabis users, and, by extension, promotes higher quality in the lab and the products it tests.

The emphasis on quality in the cannabis testing lab will only continue to grow as the "Wild West" attitudes borne from a patchwork of somewhat ambiguous legal statuses melt away, with more thoroughly standardized test methods and, presumably, federal legalization and regulation of medical and recreational cannabis products becoming the normal. Writing for Analytical Cannabis, Peak Compliance CSO Kimberly Ross imagines a future were a federally formalized national regime of testing and oversight will push "to standardize quality control, data integrity, and data traceability criteria across state lines." By extension, she adds, labs will need to strengthen their quality control (QC) and quality assessment (QA) procedures, including an investment in more costly QC samples.[107] This stands in contrast to the current state of cannabis testing, which continues to be scandalized by a small but important subset of licensed labs conducting unscrupulous activities (discussed further, at the beginning of the next chapter) such as making deals with cultivators to fudge testing values, cherry-picking the best samples to represent a batch of product, and intentionally using sub-standard equipment and methods to increase pass rates for limit-of-detection testing.[108]

Despite a lack of federal regulation, a majority of states mandating cannabis testing have chosen to force the quality issue with testing labs, requiring them to adhere to some sort of accreditation program.[107][108][109] This typically means the lab must be accredited to the ISO/IEC 17025 standard, which means sticking to a minimum set of equipment, method, and QA requirements and conducting proficiency testing at regular intervals.[107][108][109] Of course, not all accredited labs need to be accredited for every test they perform[108], which is somewhat problematic; inevitably all labs may be required to be accredited for all methodologies they apply.

Another quality concern is a lack of state-mandated proficiency testing (PT). Conducting PT essentially means running a specific set of tests where the results get evaluated by a third party who has run the same tests against a known standard. Indeed, PT is an important component of accreditation to ISO/IEC 17025[108][109][110], but given that some states still don't require accreditation[108], the likelihood of those labs going out of their way to conduct PT seems low. Those labs that are serious about quality—whether they are accredited or not—may avail themselves to programs like The Emerald Test, which "provides cannabis and hemp testing facilities with a broad range of PTs to help meet their internal SOP, regulatory compliance, and ISO/IEC accreditation needs."[111] Such efforts towards PT should, in theory, improve cannabis product quality, reduce product liability, and improve customer confidence. Of course, as Emerald Scientific's vice president Kirsten Blake notes, PTs don't test for a lab's overall ethics (meaning lab personnel could still fudge numbers outside of PTs), but "they can at least test for a lab’s competency in providing accurate results."[110]

Finally, quality in the cannabis testing laboratory may be furthered by technology. For example, laboratory automation can be used to execute processes in a precise manner every time, both providing consistency to lab results and reducing the need for human interaction with testing, freeing personnel to conduct other activities.[107] As a lab takes on more work and seeks to be more competitive, automation may transition from a "wishlist" item to a necessary one.[107] Another example of technology having the potential to improve lab quality is found with the laboratory information management system (LIMS). Discussed in more detail in the next chapter, the LIMS is increasingly vital to managing regulated data, reporting it, and helping the cannabis testing lab maintain regulatory and accreditation compliance. The LIMS can also act "as the memory of the laboratory, a vast repository for all data generated over time," as well "as a dispatch system for lab personnel, surfacing bottlenecks and issues earlier than otherwise possible in a 'paper and whiteboard' system."[107] This in turn can contribute to the quality and efficiency of the lab.[107][112]

References

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  7. ↑ Hamilton, K. (27 June 2016). "The FDA told the DEA whether pot is medicine — but it won't tell the public". Vice News. Vice Media, LLC. https://www.vice.com/en/article/pa443y/dea-fda-marijuana-schedule-1-status-decision. Retrieved 08 July 2022. 
  8. ↑ 8.0 8.1 Romza-Kutz, D.; Roth V., F. (15 August 2016). "The silver lining in the DEA’s refusal to reclassify cannabis". Tracking Cannabis. Thompson Coburn LLP. https://www.thompsoncoburn.com/insights/blogs/tracking-cannabis/post/2016-08-15/the-silver-lining-in-the-dea-s-refusal-to-reclassify-cannabis. Retrieved 08 July 2022. 
  9. ↑ Hudak, J. (20 June 2015). "The Conflict Between Federal and State Marijuana Laws Claims a Victim". Newsweek. Newsweek, LLC. https://www.newsweek.com/conflict-between-federal-and-state-marijuana-laws-claims-victim-345099. Retrieved 08 July 2022. 
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  108. ↑ 108.0 108.1 108.2 108.3 108.4 108.5 Stewart, I.A. (9 August 2021). "Reducing Cannabis Testing and Label Failures". Insights. Wilson Elser. https://www.wilsonelser.com/news_and_insights/insights/4278-reducing_cannabis_testing_and_label_failures. Retrieved 04 August 2022. 
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  111. ↑ "The Emerald Test". Emerald Scientific. https://pt.emeraldscientific.com. Retrieved 04 August 2022. 
  112. ↑ Steele, T. W.; Laugier, Alain; Falco, François (3 March 1999). "The impact of LIMS design and functionality on laboratory quality achievements". Accreditation and Quality Assurance 4 (3): 102–106. doi:10.1007/s007690050324. ISSN 0949-1775. http://link.springer.com/10.1007/s007690050324. 


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Citation information for this chapter

Chapter: 2. Regulation, standardization, and quality

Title: Past, Present, and Future of Cannabis Laboratory Testing and Regulation in the United States

Edition: Fourth edition

Author for citation: Shawn E. Douglas

License for content: Creative Commons Attribution-ShareAlike 4.0 International

Publication date: August 2022


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