Difference between revisions of "User:Shawndouglas/sandbox/sublevel4"

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'''Solvents''':
'''Solvents''':


'''Heavy metals''':
'''Heavy metals''': The methods used for quantifying levels of highly toxic metals in plants depend on ease-of-use, level of accuracy, and overall cost. The following methods are most common for testing cannabis and other plants<ref name="KuzdzalACloser16" /><ref name="CassidayTheHighs16" /><ref name="DavisAnalysis15">{{cite web |url=http://www.ssi.shimadzu.com/products/literature/aas/ssi-icp-002.pdf |format=PDF |title=Analysis of "The Big Four" Heavy Metals in Cannabis by USN-ICP-OES |author=Davis, D.; Long, K.; Masone, J.; Firmin, P. |publisher=Shimadzu Corporation |date=August 2015 |accessdate=14 February 2017}}</ref><ref name="ShimadzuCLTS">{{cite web |url=https://www.ssi.shimadzu.com/products/literature/life_science/shimadzu_cannabis_brochure.pdf |format=PDF |title=Cannabis Testing Laboratory Solutions |publisher=Shimadzu Corporation |accessdate=14 February 2017}}</ref>:
 
* Inductively coupled plasma atomic emission spectroscopy (ICP-AES), sometimes called inductively coupled plasma optical emission spectrometry (ICP-OES) (at times coupled with an ultrasonic nebulizer)
* Inductively coupled plasma mass spectroscopy (ICP-MS)
* Inductively coupled plasma tandem-mass spectroscopy (ICP-MS/MS)


'''Mycotoxins and microorganisms''': A standard method of testing for the existence of microorganisms is through the process of culturing a sample in a Petri dish, a common diagnostic method in microbiology. Enzyme-linked immunosorbent assay (ELISA) is also used, particularly to identify mycotoxins. However, Petri culture analysis isn't rigorous, and ELISA can be time consuming, as it's limited to one mycotoxin per test.<ref name="KuzdzalACloser16" /><ref name="CassidayTheHighs16" /><ref name="KennardYouAre16" /> The following are other, more precise techniques that are improving laboratorians' analyses, particularly using DNA snippets of microbiological contaminates<ref name="KuzdzalACloser16" /><ref name="CassidayTheHighs16" /><ref name="KennardYouAre16" /><ref name="ThompsonAMicro16">{{cite journal |title=A microbiome assessment of medical marijuana |journal=Clinical Microbiology and Infection |author=Thompson III, G.R.; Tuscano, J.M.; Dennis, M. et al. |pages=S1198-743X(16)30605-X |year=2017 |doi=10.1016/j.cmi.2016.12.001 |pmid=27956269}}</ref>:
'''Mycotoxins and microorganisms''': A standard method of testing for the existence of microorganisms is through the process of culturing a sample in a Petri dish, a common diagnostic method in microbiology. Enzyme-linked immunosorbent assay (ELISA) is also used, particularly to identify mycotoxins. However, Petri culture analysis isn't rigorous, and ELISA can be time consuming, as it's limited to one mycotoxin per test.<ref name="KuzdzalACloser16" /><ref name="CassidayTheHighs16" /><ref name="KennardYouAre16" /> The following are other, more precise techniques that are improving laboratorians' analyses, particularly using DNA snippets of microbiological contaminates<ref name="KuzdzalACloser16" /><ref name="CassidayTheHighs16" /><ref name="KennardYouAre16" /><ref name="ThompsonAMicro16">{{cite journal |title=A microbiome assessment of medical marijuana |journal=Clinical Microbiology and Infection |author=Thompson III, G.R.; Tuscano, J.M.; Dennis, M. et al. |pages=S1198-743X(16)30605-X |year=2017 |doi=10.1016/j.cmi.2016.12.001 |pmid=27956269}}</ref>:

Revision as of 22:45, 14 February 2017

Overview of the cannabis industry in the United States

The following is a brief overview of the cannabis industry in the United States. It's meant to give a quick and concise review of where cannabis use, regulation, testing, and research have been and where they are now. Many of the topics touched upon here will be expanded upon later in this guide.

Brief history of cannabis in the U.S.

Cannabis is a rapid-growing, flowering plant that has been used for centuries for industrial, medicinal, and recreational purposes. The plant includes three species or subspecies: indica, ruderalis, and sativa.[1] Both industrial hemp and recreational marijuana are derived from cannabis plants, but with important differences in biochemical composition. Hemp — which has historically been used to create clothing, food and feed, paper, textiles, and other industrial items — tends to have lower levels of the psychoactive component tetrahydrocannabinol (THC) and higher levels of the non-psychoactive component cannabidiol (CBD).[2][3] Some cannabis strains have intentionally been bred to produce low levels of THC, while others have been bred with the intent to maximize the psychoactive component.

Cannabis cultivation began in England's Jamestown colony of America in earnest around 1611, via formal orders. Several years later those orders turned into a royal decree, enacted by the Virginia Company, asking colonists to grow 100 hemp plants for export to England.[3] Colonial American continued its growth, use, and exportation of hemp, even beyond the foundation of the United States. During that time, growers undoubtedly were using the female plant (which flowers and has higher levels of THC) to treat aches and pains as well as enjoy it recreationally. By the time of the U.S. Civil War arrived in the 1860s, however,the growth and use of industrial hemp declined as increased cotton and wood use took away much of the profitability of hemp.[3] Around the same time, local governments began recognizing tonics, tinctures, and extracts from cannabis plants as potentially dangerous substances, labeling them as hypnotics, narcotics, or even poisons.[4] In the early twentieth century, U.S. labeling and prescription laws — such as the the Pure Food and Drug Act of 1906 at the federal level as well as various state laws — saw further restrictions put on cannabis, effectively culminating in the Marihuana Tax Act of 1937 and the Federal Food, Drug, and Cosmetic Act of 1938. With the passage of those acts, hemp and marijuana essentially became illegal, controlled substances.[5][6][7]

State efforts to decriminalize marijuana were somewhat successful in the early 1970s, though progress towards that goal slowed again with the Reagan Administration's war on drugs.[8] Progress picked up steam again in the late 1990s into the 2000s, particularly in states such as California, Massachusetts, Connecticut, Washington, and Colorado.

As of January 2017, twenty-eight U.S. states have approved some sort of broad decriminalization or legalization of medicinal and/or recreational marijuana.[9] Industrial hemp has also been addressed in some regard, with 16 states having legalized commercialized industrial help production and the federal government making certain concessions on it (Cannabis sativa containing no more than 0.3 percent THC, grown under a state-sanctioned agricultural pilot program).[10][11] However, cannabis, including industrial hemp, remains a Schedule I controlled substance, as determined by the U.S. Food and Drug Administration[12], including extracts and other derivatives such as cannabidiol (CBD).[13] This federal classification continues to clash with changing state laws and regulations at an increasing pace, creating both opportunities and difficulties for involved citizens at all points along the industrial, economic, and social chain.

Medical and recreational use

In its 2016 World Drug Report, the United Nations Office on Drugs and Crime estimated that 3.8 percent of the global population — roughly 183 million people — used cannabis in 2014.[14] Focusing in on the United States, the Substance Abuse and Mental Health Services Administration (SAMHSA) estimated that in 2014 the country had 35.1 million past-year marijuana users.[15] It's not clear if that total includes legal medical marijuana users, which numbered roughly 2.4 million that year according to non-profit ProCon.org.[16] When compared to SAMHSA's estimate of 11.1 million users in 1997[17], it becomes clear that reported marijuana use has increased in the United States over the past few decades, whether it's through legalization efforts or otherwise. Some have pointed to the expansion of medical marijuana laws acting as gateways for increased adolescent use; however, multiple studies have have tried to but failed to find such a cause and effect relationship.[18][19][20] Regardless, with 28 U.S. states now having some legalization law on the books[9], the number of marijuana users isn't likely to decrease any time soon.

Cultivation and distribution

On the Federal level, marijuana is considered a Schedule I drug and remains illegal.[21][12] (Federal regulation of cannabis is discussed in detail later under "Regulatory scheme.") This doesn't leave a lot of options for researchers and the like. In fact, the only federally-granted grow operation (grow-op) as of this writing is the University of Mississippi, contracted by the National Institute on Drug Abuse (NIDA) to grow marijuana for approved research studies.[22][23][24][25][26] (That may change for the better in 2017; see the next section on testing and research for more.)

On the state level, the growth and distribution of cannabis depends on state law, which can vary from state to state. This topic is discussed further in the "Regulatory scheme" section, but here are the key points:

  • Federal law makes it illegal to cultivate and distribute marijuana, even in a state that has legalized such activity. However, while there's no legally-binding guarantee cultivators and distributors won't be pursued by federal law enforcement, they can limit their chances of such federal enforcement by following the letter of state and local law.
  • Despite some of the variance of state laws, one aspect largely remains consistent: it's illegal to distribute marijuana over state lines, even when it's between two states with similar laws.[27]
  • Regulations on the personal and commercial cultivation and distribution of marijuana vary significantly from state to state. Some states make a limited pool of available licenses available; others don't offer them or instead have specific alternative treatment or non-profit centers that handle growth and distribution.[28][29][30]

Testing and research

One area that continues to expand — while taking advantage of new scientific research and techniques — is the laboratory sphere, particularly in research, regulation, and standardization activities. According to July 2016 testimony from Susan R.B. Weiss, Division Director at the National Institute on Drug Abuse (NIDA), the National Institutes of Health (NIH) alone supported 281 cannabinoid research projects totally more than $111 million in 2015.[24]

While the research, analysis, and processing of cannabis has been ongoing for centuries[3], it wasn't until 1896 that Wood et al. conducted one of the first documented chemical experiments to determine the constituents of cannabis. Several years later, the researchers were able to correctly identify the extracted and isolated cannabinol from the exuded resin of Indian hemp as C21H26O2.[31] As of mid-2015, 104 of the more than 750 constituents of Cannabis sativa have been identified as cannabinoids[32], "a class of diverse chemical compounds that act on cannabinoid receptors in cells that modulate neurotransmitter release in the brain."[33]

Yet in the United States, when it comes to 1. enacting the broad level of testing required to ensure public safety — whether it be medical, recreational, or industrial use of cannabis — and 2. researching and better understanding the pharmacokinetics and pharmacodynamics (medical use and benefit) of cannabinoids in the human population, many have argued that laboratory testing of cannabis is still in its infancy[34][35][36][37][38][39] and evidence-based research of marijuana continues to be slow and bogged down in regulation.[22][23][24][25][26] In regards to the first issue, as some form of legalization continues to sweep across states, regulators, users, and industry are recognizing the need for improved standardization of the production and testing of medical and recreational marijuana; the current state of improper labeling and potentially harmful contaminants[34][35][36][39] will only serve to hinder the industry. To the second issue, some within the federal government seem to recognize the roadblocks to improved evidence-based research and are working to slowly improve how researchers can legally acquire and test marijuana in the U.S.[24][25][40]

An excerpt from the previously mentioned testimony of NIDA's Dr. Weiss summates this well:

The current state of the research on marijuana and its constituent cannabinoids suggests the potential for therapeutic value for a number of conditions; however, more evidence is needed before marijuana or cannabinoid products (beyond those already approved through the Food and Drug Administration [FDA]) are ready for medical use. Promising preclinical findings do not always prove to be clinically relevant, and even fewer lead to new treatments. Moreover, clinical studies of sufficient quality to meet FDA standards for drug approval are currently lacking for most conditions. Among the factors that impact this research are the specific statutory requirements and treaty obligations that govern research on marijuana. NIH is working closely with the Office of National Drug Control Policy (ONDCP), the Drug Enforcement Administration (DEA), and FDA to explore ways to streamline these processes to facilitate research.[24]

In the meantime, government entities such as the National Institutes of Health and non-profits such as jCanna push forward with scientific conferences, summits, and roundtables that bring scientists and interested parties together to share existing knowledge and testing techniques.[41][42]

Other areas of concern

When examining the current U.S. cannabis industry, it's important to note a few additional areas of concern that impact it, again tightly linked to federal regulations (which are discussed extensively in the next section): banking and advertising. Issues related to both of these topics continue to limit how state-based grow-ops (grow operations), dispensaries, and testing laboratories are funded and operated.

Banking

Since the U.S. federal government still considers marijuana to be illegal, by extension banks and credit unions — which are regulated by a patchwork collection of federal (and state) laws — put themselves into potentially dangerous territory by accepting money from depositors engaging in federally illegal activities; the bank can be punished by federal institutions such as that Federal Deposit Insurance Corporation (FDIC).[43] In an attempt to ease concerns of industry and banks in states that had implements legalization efforts, the Treasury Department's Financial Crimes Enforcement Network (FinCEN) released a guidance document in February 2014 that "does not grant immunity from prosecution or civil penalties to banks that serve legal marijuana businesses" but rather "directs prosecutors and regulators to give priority to cases only where financial institutions have failed to adhere to the guidance."[44][45] However, the guidance has remained just that: guidance; it doesn't prevent federal law enforcement or regulating agencies from taking action. An August 2016 attempt to reclassify marijuana into a lower classification than Schedule I failed[12][25], keeping the FinCEN guidance in place as a recommendation for how federal authorities should enforce existing law.

According to an Associated Press report in April 2016, the guidance has had some sort of impact, with banks and credit unions willing to handle any money associated with marijuana increasing from 51 in March 2014 to 301 in March 2016.[46] However, this hasn't prevented those in states with newly minted medical and recreational marijuana legalization laws from being worried about how cannabis money will be handled, particularly with the new Trump administration taking the reigns of government. California, which in November 2016 legalized recreational use of marijuana beginning in 2018, has already petitioned that administration to clarify it's policy early on. "We have a year to develop a system that works in California and which addresses the many issues that exist as a result of the federal-state legal conflict," wrote California Treasurer John Chiang to Trump. "Uncertainty about the position of your administration creates even more of a challenge."[47]

Similar legalization changes in Massachusetts prompted its senator Elizabeth Warren, along with nine other senators, to write to FinCEN in early 2017 requesting even clearer, more friendly guidance for marijuana vendors.[48] Yet it remains to be seen if entities outside of grow-ops and dispensaries will see banking relief. In particular, testing laboratories continue to struggle with managing cash flow and acquiring bank lending for their operations[49][50][51], causing some to believe consolidation of such labs will occur before the industry can really even take off.[49][52]

Advertising

Advertising of marijuana products is another area of concern, though the regulations and laws regarding it are less clear. When it comes to television and radio broadcasting and its associated advertising, a federally-granted broadcasting license stands to be lost care of the Federal Communications Commission (FCC). The trouble is, it's not clear if the FCC would act against broadcasters; the FCC hasn't issued guidance in the same way FinCEN has. "I don’t think anybody knows, and that’s the problem," said California Broadcasters Association President Joe Berry in an August 2016 report published by the The Sacramento Bee. "Without a clear indication [from the FCC on marijuana advertising], the vast majority of broadcasters are going to stay away from this issue."[53] California, of course, made recreational marijuana legal, and its proposed law sought to address the issue of advertising, including "a provision restricting TV and radio ads so they are not targeted to minors," while also addressing the authority of the FCC to enforce regardless.[54]

Other forms of advertising also remain problematic. In late November 2015, the United States Postal Service (USPS) out of Portland, Oregon published its interpretation of federal law regarding "mailpieces containing advertisements about marijuana," regarding it illegal to distribute certain forms of marijuana advertisement, citing 21 U.S. Code § 843(c).[55] The U.S. Patent and Trademark Office (PTO) has, controversially, also gotten involved, stating that trademarking of a "brand controlled substances or related paraphernalia that are illegal to possess or sell" legally doesn't fit within a trademark's commercial viability because at the federal level marijuana is not legal for commerce.[56] (Legal experts such as Dariush Adli suggest "creative ways" of getting around this, from registering trademarks in multiple states to registering "non-cannabis merchandise in order to generate some federal protection for their mark."[57]) Even billboards are an issue, with state lawmakers proposing new regulations on marijuana advertising on them weeks after the state passed its recreational legalization laws.[58] And state laws, such as those found in Alaska, can create their own set of challenges in staying legal with marijuana advertising.[59]

Despite all this, at least one financial consultant believes marijuana marketing will become more prevalent: GreenWave Advisors' Matthew Karnes estimates spending will jump to $75 million by 2021.[60]

Regulatory scheme

Federal

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.[21] Marijuana was initially placed under Schedule I[21] and remains there today.[12][25][61] As a Schedule I drug, the federal government is indicating marijuana has[21]:

  • "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).[62][63] Then President Richard Nixon said of the transition[62]:

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.[62] Since then the DEA has taken various steps — with guidance from the Food and Drug Administration (FDA)[64] — 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 in maintaining marijuana as a Schedule I drug.[40][65]

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).[66] 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.[67] 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.[68] 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.[69]

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.[70] The language of the memo essentially said "get off your butts and nail those suckers."[71] Cambron et al.[68] and Fairman[72] 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 in unnecessarily on states that have passed legalization laws and 2. Washington and Colorado legalizing recreational use of cannabis.[68] 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."[73] 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.[74][68] 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.[71]

December 16, 2014 to current: Rohrabacher-Farr Amendment

A tenuous truce of sorts arrived with the passage of the Rohrabacher-Farr 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 consistent with state laws.[75] Before being passed in December 2014, the amendment had actually been introduced and defeated six times in the previous 10 years.[76] 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 both cases, the courts ruled against the DoJ, setting precedent against further department action.[77][78]

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. As of January 2017, it was last renewed through April 2017; however, with the new Trump administration coalescing — including Trump's demonstrably anti-drug U.S. Attorney General nominee Jeff Sessions — some in the industry are concerned the amendment may not be renewed, opening the door again for the DoJ to implement stronger enforcement.[9][79][80][81]

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.[12][25][61] Reasons included known health issues such as prenatal exposure and negative impacts on several biological systems as well as limited research and new drug applications.[40] 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."[82]

State medical and recreational

As of January 2017, 28 states have some sort of broad decriminalization or legalization laws for cannabis on the books.[9] 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.[83] 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.[68][84] 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.[68] Colorado, Maine, Massachusetts, and Nevada followed suit in 2016.[85]

As shown by Cambron et al. in 2016 (before the November election results)[68], 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.[68]

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[86]:

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."[68]

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.[87]

In the meantime, scientists and government officials are doing what they can to harmonize standards and regulations. 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.[88] Additionally, organizations such as Americans for Safe Access Foundation (ASAF), American Herbal Pharmacopoeia (AHP), American Herbal Products Association (AHPA), and the American Oil Chemists' Society (AOCS) have been developing standards, methods, and certifications for analysis, extraction, labeling, and laboratory operations surrounding medical marijuana.[89][90][91][92][93]

Laboratory testing of cannabis

The overview mentioned how regulators, users, and industry are calling for improved standardization of the production and testing of medical and recreational marijuana. Without proper testing of medical and recreational marijuana, several issues are bound to arise[34][35][36][39][93][94]:

  • label claims may not match actual contents;
  • contaminants may linger, causing illness or even death;
  • chemical properties and medicinal benefits of specific strains and their unique cannabinoid-turpene profiles can't be isolated; and
  • research on potential therapeutic qualities can't be replicated, hindering scientific progress.

In 2011 — a year before any U.S. state had enacted broad legalization of recreational marijuana — California NORML reported that its assessment of analytical cannabis testing laboratories' accuracy found that while California labs broadly reached +/- 20 percent consistency from a replicate sample, three out of ten provided unfavorable results on at least half of their tests. Similar wide-ranging discrepancies were also found among edibles, extracts, and tinctures, and NORML found that none of the labs could reach two decimal points precision of cannabinoid results despite laboratory claims stating otherwise.[94] Another report out of Washington State in January 2015, not long after recreational marijuana sales to the public (requiring accredited lab testing prior) began[95], found blind tests of recreational marijuana at dispensaries could range as much as 7.5 percent in accuracy from its corresponding label.[35] Further issues in 2016 with alleged partiality by some Washington testing laboratories prompted emergency proficiency testing rules to be enacted.[96][97] (Proficiency testing essentially requires a laboratory in question to test a sample with known properties, and then those results are compared to those of a neutral third-party lab testing the same sample.)

These discrepancies and deficiencies highlight the growing need for homogenization of testing methods and procedures, if not nationally at least across an entire state. Such homogenization would, in theory, not only positively affect the quality of product but also provide greater consumer confidence that label and product match. As Marketing Director Scott Kuzdzal of Shimadzu pointed out during a January 2017 webinar on analytic testing of cannabis, poor sample preparation, lack of thorough testing, and the manual process itself — which can introduce user error, particularly when good laboratory practices aren’t used — all can contribute to discrepancies between label and product.[98] When dispensaries, edible manufacturers, and supplement companies perform insufficient lab testing or overstate claims on labels, it reduces consumer confidence, and both state and federal authorities — including the FDA — have to interject.[96][97][99]

As was mentioned at the end of the previous section on state regulation, efforts to improve testing methods and procedures, with the goal of seeing the best of them become standards, are ongoing. Where are those efforts now, and where are they going? Before we can examine that, we first need to briefly look at what aspects of cannabis are actually being analyzed.

Analytical aspects of cannabis

Cannabinoids

As of mid-2015, researchers have identified 104 of the more than 750 constituents of Cannabis sativa as cannabinoids[32], active chemical compounds that act in a similar way to compounds our body naturally produces. Many of our body's cells have cannabinoid receptors capable of modulating neurotransmitter release in the brain and other areas.[33] The plant's cannabinoids vary, with each bonding to specific receptors in our body, providing differing effects. From a theoretical and medical standpoint, crafting a strain of cannabis that has specific cannabinoids that can aid with a particular malady, while also carefully reproducing the grow conditions to consistently make that strain in the future, is a desirable but difficult goal to achieve.[100]

Lab testing of cannabinoids is done primarily as a measure of psychoactive "potency," though cannabinoids have many other potential therapeutic uses. Current laboratory testing looks at only a handful of cannabinoids; more research and development of analytical techniques that can quickly and accurately detect and separate the the rest is required.[37] Some of the major cannabinoids tested for include[37][101]:

  • THC (∆9-Tetrahydrocannabinol): This is the most commonly known cannabinoid found in cannabis, notable for its strong psychoactive effects and ability to aid with pain, sleep, and appetite issues. Included is its analogue ∆8-Tetrahydrocannabinol (which shows notably less strong psychoactive effects than ∆9[102]) and its homologue THCV (Tetrahydrocannabivarin), which tends to appear in trace amounts and has a more pronounced psychoactive effect, but for a shorter duration. THCV shows promise in fighting anxiety, tremors from neurological disorders, appetite issues, and special cases of bone loss. Also notable is Δ9-THCA (Δ9-Tethrahydrocannibinolic acid), a non-psychoactive biosynthetic precursor to THC.
  • CBC (Cannabichromene): This non-psychoactive cannabinoid is found in trace amounts; however, it tends to be markedly more effective at treating anxiety and stress than CBD (see next). It's also notable for its anti-inflamatory properties and potential use for bone deficiencies.
  • CBD (Cannabidiol): CBD is a non-psychoactive component of cannabis, typically accounting for up to 35 to 40 percent of cannabis extracts. It acts as a counter-balance to THC, regulating its psychoactivity. It's been researched as a treatment for anxiety, sleep loss, inflammation, stress, pain, and epilepsy, among other afflictions. Included is its homologue CBDV (Cannabidivarin), which is also non-psychoactive and demonstrates promise as a treatment for epileptic seizures. Also notable is CBDA (Cannabidiolic acid), a non-psychoactive biosynthetic precursor to CBD.
  • CBG (Cannabigerol): This cannabinoid is also non-psychoactive but only appears in trace amounts of cannabis. If has potential as a sleep aid, anti-bacterial, and cell growth stimulant. Also notable is CBGA (Cannabigerolic acid ), a non-psychoactive biosynthetic precursor to CBG.
  • CBN (Cannabinol): CBN is mildly psychoactive at best and appears only in trace amounts in Cannabis sativa and Cannabis indica. It occurs largely as a metabolite of THC and tends to have one of the strongest sedative effects among cannabinoids. It shows promise as a treatment for insomnia, glaucoma, and certain types of pain.

Terpenes

Mandated lab testing of terpenes — volatile organic compounds that distinctly affect cannabis aroma and taste — is done primarily as a way to ensure proper labeling of cannabis and related products, including extracts and concentrates, so buyers have confidence in what they are purchasing.[103][104][105] However, additional lab research goes into terpenes as they also show potentially useful pharmacological properties[103][105][106], and they demonstrate synergies (referred to at times as the "entourage effect") with cannabinoids that largely still require further exploration.[93][106][105][107] Testing for specific terpenes (discussed later) is less of a standardized practice, though it's rapidly improving.[103] Commonly tested terpenes by third-party testing labs include[105][104][106][93][101][108]:

  • Bisabolol
  • Caryophyllene
  • Cymene
  • Humulene
  • Limonene
  • Linalool
  • Myrcene
  • Phytol
  • Pinene
  • Terpinolene

Contaminates

Generally speaking, a contaminate is an unwanted substance that may show up in the final product, be it recreational marijuana or a pharmaceutical company's therapeutic tincture. The following are examples of contaminates that laboratories may test for in cannabis products.

Pesticides: Pesticides represent the Wild West of not only growing cannabis but also performing analytical testing on it. One of the core issues, again, is the fact that on the federal level marijuana is illegal. Because it's illegal, government agencies such as the Environmental Protection Agency (EPA) don't test and create standards or guidelines for what's safe when it comes to residual pesticides, let alone how to best test for them.[109][110] Additionally, researchers face their fair share of difficulties obtaining product to test. The end result is we don't know much about how inhalation of pesticide-coated marijuana smoke affects long-term health[109][110], and we don't have standards for pesticide application and testing.[93] With numerous pesticide products and little oversight on what growers apply to their plants, combined with the technical difficulty of testing for pesticides in the lab, pesticides remain one of the most difficult contaminates to test for.[93] That said, several classes of of pesticides are commonly applied during cannabis cultivation and can be tested for by labs[39][111]:

  • avermectins: used as insecticides that are useful against mites, which are a common problem for cultivators
  • carbamates: insecticide similar to organophosphates, but with decreased dermal toxicity and higher degradation
  • organophosphates: functions as the base of many insecticides and herbicides, valued for its easy organic bonding
  • pyrethroids: functions as the base of most household insecticides and exhibits insect repellent properties


Solvents: In 2003, Canadian Rick Simpson published a recipe of sorts for preparing cannabis extract via the use of solvents such as naphtha or petroleum ether. Claiming the resulting oil helped cure his skin cancer, others hoping for a cure tried it, and the solvent method of preparation grew in popularity. Dubious healing claims aside, the solvent extraction method remains viable, though it has evolved over the years to include less harmful solvents such as supercritical carbon dioxide, which has low toxicity, low environmental impact, and beneficial extraction properties.[93][112][113] However, chemical solvents are still used, and if not evaporated out properly, the remaining solvents can be particularly harmful to sick patients using the extract. As for what solvents should be tested for, it gets a bit trickier, though Chapter 467 of United States Pharmacopeia and The National Formulary and the Oregon Health Authority's December 2015 technical report on contaminant testing of cannabis provide helpful guidance. Listed solvents include benzene, butane, cumene, dimethoxyethane, hexane, and pentane, among others.[39][93][111][114]


Heavy metals: 2013 research on contaminant testing on the behalf of Washington State provides insights into heavy metals and why they're looked for in cannabis testing. That research, as well as other sources, tell us[39][93][115]:

  • Heavy metals contribute to several health problems, including those of a neurological nature.
  • Cannabis can "hyperaccumulate metals from contaminated soils."
  • Research parallels can be found in tobacco research and how the FDA regulates heavy metal content in foods.
  • The most prominently tested heavy metals include arsenic (As), cadmium (Cd), chromium (Cr), lead (Pb), and mercury (Hg).


Mycotoxins and microorganisms: "The ideal conditions for cannabis growth are also ideal for the growth of potentially harmful bacteria and fungi, including yeast and molds," say Shimadzu's Scott Kuzdzal and William Lipps, "therefore microbial contamination poses health risks to consumers and immunocompromised individuals."[37] In truth, these concerns have already borne out; most recently the University of California, Davis reported in February 2017 one of its patients had contracted an incurable fungal infection from inhaling aerosolized marijuana. They later tested 20 marijuana samples from Northern California dispensaries — using specialized techniques — and found a wide variety of potentially hazardous microorganisms.[116]

The degree to which such contaminates commonly appear in grown and stored cannabis material and to which microbiological contaminates should be tested is not clear, however. As mentioned previously, neither the U.S. EPA or neighboring Health Canada provide any significant guidance on cannabis testing, including microbiological contaminates.[117] Like heavy metal testing, parallels are drawn from microbial testing guidelines and standards relating to tobacco and food, where they exist.[117] As warm, moist environments are conducive to microorganism growth, maintaining stable moisture levels during cultivation and storage is essential. Regularly measuring water activity — how moist something is — is particularly useful as a front-line preventative tool to better ensure microbial growth is limited.[111] Regardless, testing of some kind is still required by many U.S. states, including for organisms such as[37][93][111][116][117][118][119]:

  • Aflatoxin
  • Alternaria
  • Aspergillus
  • Cryptococcus
  • E. coli
  • Mucor
  • Penicillium
  • Salmonella

Methods and guidelines

Now that we've addressed what's being tested for, we can move on to how they're being tested and what's being done to improve testing methods and procedures, including associated guidelines and recommendations. It would be beyond the scope of this guide to include every state's laws and guidelines on cannabis testing; entities such as Leafly Holdings[120] and CannaGuard Security[121] provide such online resources. Instead, this section will focus on current and promising techniques using generalizations based on information from multiple sources. If any guidelines and recommendations are known, they'll be included.

Cannabinoid testing

Terpene testing

Contaminate testing

Pesticides:

Solvents:

Heavy metals: The methods used for quantifying levels of highly toxic metals in plants depend on ease-of-use, level of accuracy, and overall cost. The following methods are most common for testing cannabis and other plants[39][93][122][123]:

  • Inductively coupled plasma atomic emission spectroscopy (ICP-AES), sometimes called inductively coupled plasma optical emission spectrometry (ICP-OES) (at times coupled with an ultrasonic nebulizer)
  • Inductively coupled plasma mass spectroscopy (ICP-MS)
  • Inductively coupled plasma tandem-mass spectroscopy (ICP-MS/MS)

Mycotoxins and microorganisms: A standard method of testing for the existence of microorganisms is through the process of culturing a sample in a Petri dish, a common diagnostic method in microbiology. Enzyme-linked immunosorbent assay (ELISA) is also used, particularly to identify mycotoxins. However, Petri culture analysis isn't rigorous, and ELISA can be time consuming, as it's limited to one mycotoxin per test.[39][93][117] The following are other, more precise techniques that are improving laboratorians' analyses, particularly using DNA snippets of microbiological contaminates[39][93][117][124]:

  • Quantitative polymerase chain reaction (qPCR)
  • Whole metagenome shotgun (WMGS) sequencing
  • Matrix-assisted laser desorption/ionization (MALDI)
  • High performance liquid chromatography (HPLC)
  • Liquid chromatography tandem-mass spectrometry (LC-MS/MS)


Reports

Lab equipment used

Software

Testing labs and pricing info

Future of cannabis testing and market trends

Resources

Reference material




Law and regulation





Publications and blogs

Standards and guidance



Testing and accreditation







Conferences and trade shows




Associations and organizations


Producers and vendors

Hardware vendors

Software vendors

LIMS

Seed-to-sale

LIMSpec

References

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  72. ↑ Fairman, B.J. (2016). "Trends in registered medical marijuana participation across 13 US states and District of Columbia". Drug and Alcohol Dependence 159: 72–9. doi:10.1016/j.drugalcdep.2015.11.015. PMID 26686277. 
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  74. ↑ "Federal Marijuana Enforcement Policy". Marijuana Policy Project. 2016. https://www.mpp.org/federal/federal-enforcement-policy-on-state-marijuana-laws/. Retrieved 26 January 2017. 
  75. ↑ 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. 
  76. ↑ Brekke, D. (30 May 2014). "House Votes to End Medical Marijuana Prosecutions". KQED News. KQED, Inc. https://ww2.kqed.org/news/2014/05/30/house-votes-to-block-medical-pot-prosecution/. Retrieved 27 January 2017. 
  77. ↑ Ingraham, C. (20 October 2015). "Federal court tells the DEA to stop harassing medical marijuana providers". The Washington Post. WP Company, LLC. https://www.washingtonpost.com/news/wonk/wp/2015/10/20/federal-court-tells-the-dea-to-stop-harassing-medical-marijuana-providers/. Retrieved 27 January 2017. 
  78. ↑ Fermer, M. (16 August 2016). "The Largest Federal Appeals Court Tells DOJ To Back Off State-Legal Medical Marijuana". The Huffington Post. TheHuffingtonPost.com, Inc. http://www.huffingtonpost.com/entry/medical-marijuana-9th-circuit_us_57b36a31e4b04ff883990337. Retrieved 27 January 2017. 
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  84. ↑ "Election Summary Report, State of Alaska 1998 General Election: Official Results". Election Results. State of Alaska Division of Elections. 1 December 1998. http://www.elections.alaska.gov/results/98GENR/results.htm. Retrieved 1 February 2017. 
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  87. ↑ Cole, T.; Trumble, S.; Hatalsky, L.E. (17 February 20116). "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. 
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  90. ↑ Cannabis Committee, AHPA (2 February 2016). "Recommendations for Regulators – Cannabis Operations" (PDF). American Herbal Products Association. http://www.ahpa.org/Portals/0/pdfs/AHPA_Recommendations_for_Regulators_Cannabis_Operations.pdf. 
  91. ↑ Upton, R.; Craker, L.; ElSohly, M. et al., ed. (2014). Cannabis Inflorescence: Cannabis spp.. American Herbal Pharmacopoeia. ISBN 1929425333. http://www.herbal-ahp.org/order_online.htm. 
  92. ↑ Project CBD; Marcu, J. (16 March 2016). "Jahan Marcu: Cannabis Lab Testing & Safety Protocols". Project CBD. Project CBD. https://www.projectcbd.org/article/jahan-marcu-cannabis-lab-testing-safety-protocols. Retrieved 03 February 2017. 
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  94. ↑ 94.0 94.1 "How Accurate Is Cannabis Potency Testing?". California NORML. 21 September 2011. http://canorml.org/news/ringtest.html. Retrieved 03 February 2017. 
  95. ↑ "FAQs on I-502". Washington State Liquor and Cannabis Board. http://lcb.wa.gov/mj2015/faqs_i-502. Retrieved 03 February 2017. 
  96. ↑ 96.0 96.1 Young, B. (5 January 2016). "Some pot labs in state failed no pot at all, says scientist". The Seattle Times. The Seattle Times Company. http://www.seattletimes.com/seattle-news/marijuana/some-pot-labs-in-state-failed-no-pot-at-all-says-scientist/. Retrieved 03 February 2017. 
  97. ↑ 97.0 97.1 Coughlin-Bogue, T. (11 March 2016). "To Combat Inconsistency, Washington Testing Labs Turn to Self-Policing". Leafly - Politics. Leafly Holdings, Inc. https://www.leafly.com/news/politics/to-combat-claims-of-inconsistency-washington-testing-labs-turn-to. Retrieved 03 February 2017. 
  98. ↑ Kuzdzal, S.A. (19 January 2017). "Webinar: Opportunities & Challenges in Cannabis Analytical Testing". Shimadzu Corporation. Archived from the original on 19 January 2017. http://web.archive.org/web/20170119200158/http://www.shimadzu.com.cn/an/news-events/news/2017/4381.html. Retrieved 03 February 2017. "Source is actual webinar." 
  99. ↑ "2016 Warning Letters and Test Results for Cannabidiol-Related Products". Public Health Focus. U.S. Food and Drug Administration. 31 August 2016. http://www.fda.gov/newsevents/publichealthfocus/ucm484109.htm. Retrieved 03 February 2017. 
  100. ↑ Rahn, B. (22 January 2014). "Cannabinoids 101: What Makes Cannabis Medicine?". Leafly - Cannabis 101. Leafly Holdings, Inc. https://www.leafly.com/news/cannabis-101/cannabinoids-101-what-makes-cannabis-medicine. Retrieved 03 February 2017. 
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  102. ↑ "delta-8-tetrahydrocannabinol". NCI Drug Dictionary. National Institutes of Health, National Cancer Institute. https://www.cancer.gov/publications/dictionaries/cancer-drug?cdrid=485262. Retrieved 08 February 2017. 
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  106. ↑ 106.0 106.1 106.2 Andre, C.M.; Hausman, J.-F.; Guerriero, G. (2016). "Cannabis sativa: The plant of the thousand and one molecules". Frontiers in Plant Medicine 7: 19. doi:10.3389/fpls.2016.00019. PMC PMC4740396. PMID 26870049. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4740396. 
  107. ↑ Wachsberger, K. (2 February 2016). "Terpene Testing: The future of Cannabis is here". Bloom Blog. Bloom City Club. http://www.bloomcityclub.com/terpine-testing-the-future-of-cannabis-is-here/. Retrieved 08 February 2017. 
  108. ↑ "Terpene Analysis". SC Labs, Inc. http://sclabs.com/terpene-analysis/. Retrieved 08 February 2017. 
  109. ↑ 109.0 109.1 Borel, B. (31 August 2015). "The Wild West of Marijuana Pesticides". The Atlantic. The Atlantic Monthly Group. https://www.theatlantic.com/health/archive/2015/08/pot-marijuana-pesticide-legalization/401771/. Retrieved 09 February 2017. 
  110. ↑ 110.0 110.1 Zhang, S. (7 August 2015). "Nobody Knows What to Do About Pesticides in Legal Marijuana". Wired. Condé Nast. https://www.wired.com/2015/08/nobody-knows-pesticides-legal-marijuana//. Retrieved 09 February 2017. 
  111. ↑ 111.0 111.1 111.2 111.3 Farrer, D.G. (December 2015). "Technical Report: Oregon Health Authority’s Process to Determine Which Types of Contaminants to Test for in Cannabis Products, and Levels for Action" (PDF). Oregon Health Authority. https://public.health.oregon.gov/PreventionWellness/marijuana/Documents/oha-8964-technical-report-marijuana-contaminant-testing.pdf. Retrieved 09 February 2017. 
  112. ↑ Romano, L.L.; Hazekamp, A. (2013). "Cannabis oil: Chemical evaluation of an upcoming cannabis-based medicine" (PDF). Cannabinoids 1 (1): 1–11. http://www.stcm.ch/en/files/hazekamp_cann-oil_2013.pdf. 
  113. ↑ Peach, J.; Eastoe, J. (2014). "Supercritical carbon dioxide: A solvent like no other". Journal of Organic Chemistry 10: 1878-95. doi:10.3762/bjoc.10.196. PMC PMC4168859. PMID 25246947. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4168859. 
  114. ↑ "<467> Residual Solvents" (PDF). United States Pharmacopeia and The National Formulary. United States Pharmacopeial Convention. 1 July 2007. https://www.usp.org/sites/default/files/usp_pdf/EN/USPNF/generalChapter467Current.pdf. Retrieved 09 February 2017. 
  115. ↑ Daley, P.; Lampach, D.; Sguerra, S. (12 September 2013). "Testing Cannabis for Contaminants" (PDF). BOTEC Analysis Corp. http://lcb.wa.gov/publications/Marijuana/BOTEC%20reports/1a-Testing-for-Contaminants-Final-Revised.pdf. Retrieved 09 February 2017. 
  116. ↑ 116.0 116.1 "UC Davis study finds mold, bacterial contaminants in medical marijuana samples". UC Davis. 7 February 2017. http://www.ucdmc.ucdavis.edu/publish/news/newsroom/11791. Retrieved 10 February 2017. 
  117. ↑ 117.0 117.1 117.2 117.3 117.4 Kennard, M. (2 June 2016). "You are Probably Smoking Mouldy Weed - Why Does Quality Assurance Matter?". Populace. Tantalus Labs. https://tantaluslabs.com/populace/you-are-probably-smoking-mouldy-weed-why-does-quality-assurance-matter/. Retrieved 10 February 2017. 
  118. ↑ "Microbiological study of Cannabis samples". Fundación CANNA. 2014. http://www.fundacion-canna.es/en/microbiological-study-cannabis-samples. Retrieved 10 February 2017. 
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