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| ==Sandbox begins below== | | ==The laws themselves== |
| With a sense of history and a better understanding of the regulations and standards affecting cannabis testing and use, this chapter can finally dig into the specifics of the current and future state of laboratory testing of cannabis and related products in the U.S. Here we look at the analytical aspects of cannabis, methods and guidelines used as well as the equipment and software typical to cannabis testing labs.
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| <div align="center">-----Return to [[LII:Past, Present, and Future of Cannabis Laboratory Testing and Regulation in the United States|the beginning]] of this guide-----</div>
| | ===1. Federal Telecommunications Act of 1996, Section 255 ([https://www.law.cornell.edu/uscode/text/47/255 47 U.S.C. § 255 - Access by persons with disabilities])=== |
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| ==3. Laboratory testing of cannabis==
| | <blockquote>'''(b) Manufacturing''' |
| [[File:Lilly96A.jpg|right|220px]]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, several issues are bound to arise<ref name="HazekampCanna12">{{cite journal |title=Cannabis - from cultivar to chemovar |journal=Drug Testing and Analysis |author=Hazekamp, A.; Fischedick, J.T. |volume=4 |issue=7–8 |pages=660–7 |year=2012 |doi=10.1002/dta.407 |pmid=22362625}}</ref><ref name="BushWorlds15">{{cite web |url=http://www.seattletimes.com/seattle-news/worldrsquos-strongest-weed-potency-testing-challenged/ |title=World’s strongest weed? Potency testing challenged |author=Bush, E. |work=The Seattle Times |publisher=The Seattle Times Company |date=18 February 2015 |accessdate=25 January 2017}}</ref><ref name="RutschQuality15">{{cite web |url=http://www.npr.org/sections/health-shots/2015/03/24/395065699/quality-testing-legal-marijuana-strong-but-not-always-clean |title=Quality-Testing Legal Marijuana: Strong But Not Always Clean |author=Rutsch, P. |work=Shots |publisher=National Public Radio |date=24 March 2015 |accessdate=25 January 2017}}</ref><ref name="KuzdzalACloser16">{{cite web |url=http://event.lvl3.on24.com/event/13/38/14/4/rt/1/documents/resourceList1484589923854/emerging_cannabis_industry_whitepaper.pdf |archiveurl=http://web.archive.org/web/20170210234439/http://event.lvl3.on24.com/event/13/38/14/4/rt/1/documents/resourceList1484589923854/emerging_cannabis_industry_whitepaper.pdf |format=PDF |title=A Closer Look at Cannabis Testing |author=Kuzdzal, S.; Clifford, R.; Winkler, P.; Bankert, W. |publisher=Shimadzu Corporation |date=December 2016 |archivedate=19 January 2017 |accessdate=19 January 2017}}</ref><ref name="CassidayTheHighs16">{{cite web |url=https://www.aocs.org/stay-informed/read-inform/featured-articles/the-highs-and-lows-of-cannabis-testing-october-2016 |title=The Highs and Lows of Cannabis Testing |author=Cassiday, L. |work=INFORM |publisher=American Oil Chemists' Society |date=October 2016 |accessdate=03 February 2017}}</ref><ref name="CANORMLHow11">{{cite web |url=http://canorml.org/news/ringtest.html |title=How Accurate Is Cannabis Potency Testing? |publisher=California NORML |date=21 September 2011 |accessdate=03 February 2017}}</ref>:
| | A manufacturer of telecommunications equipment or customer premises equipment shall ensure that the equipment is designed, developed, and fabricated to be accessible to and usable by individuals with disabilities, if readily achievable. |
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| * label claims may not match actual contents;
| | '''(c) Telecommunications services''' |
| * contaminants may linger, causing illness or even death;
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| * chemical properties and medicinal benefits of specific strains and their unique cannabinoid-turpene profiles can't be isolated; and
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| * research on potential therapeutic qualities can't be replicated, hindering scientific progress.
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| 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 10 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.<ref name="CANORMLHow11" /> Another report out of the state of Washington in January 2015, not long after recreational marijuana sales to the public (requiring accredited lab testing prior) began<ref name="WLCBFAQ">{{cite web |url=http://lcb.wa.gov/mj2015/faqs_i-502 |title=FAQs on I-502 |publisher=Washington State Liquor and Cannabis Board |accessdate=03 February 2017}}</ref>, found blind tests of recreational marijuana at dispensaries could range as much as 7.5 percent in accuracy from its corresponding label.<ref name="BushWorlds15" /> Further issues in 2016 with alleged partiality by some Washington testing laboratories prompted emergency proficiency testing rules to be enacted.<ref name="YoungSome16">{{cite web |url=http://www.seattletimes.com/seattle-news/marijuana/some-pot-labs-in-state-failed-no-pot-at-all-says-scientist/ |title=Some pot labs in state failed no pot at all, says scientist |author=Young, B. |work=The Seattle Times |publisher=The Seattle Times Company |date=05 January 2016 |accessdate=03 February 2017}}</ref><ref name="Coughlin-BogueToCombat16">{{cite web |url=https://www.leafly.com/news/politics/to-combat-claims-of-inconsistency-washington-testing-labs-turn-to |title=To Combat Inconsistency, Washington Testing Labs Turn to Self-Policing |work=Leafly - Politics |author=Coughlin-Bogue, T. |publisher=Leafly Holdings, Inc |date=11 March 2016 |accessdate=03 February 2017}}</ref> ("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.) Additional testing problems in Alaska and Washington labs in late 2017 found high disparities between two different testing labs, as well as a laboratory that couldn't "properly perform a coliform test that looks for bacteria."<ref name="RitchieInconsist18">{{cite web |url=https://terpenesandtesting.com/category/testing/cannabis-testing-lab-test-inconsistencies/ |title=Inconsistency in Cannabis Lab Testing |author=Ritchie, H. |work=Terpenes and Testing Magazine |date=29 April 2018 |accessdate=15 November 2018}}</ref>
| | A provider of telecommunications service shall ensure that the service is accessible to and usable by individuals with disabilities, if readily achievable. |
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| 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.<ref name="KuzdzalOpp17">{{cite web |url= http://www.shimadzu.com.cn/an/news-events/news/2017/4381.html |archiveurl=http://web.archive.org/web/20170119200158/http://www.shimadzu.com.cn/an/news-events/news/2017/4381.html |title=Webinar: Opportunities & Challenges in Cannabis Analytical Testing |author=Kuzdzal, S.A. |publisher=Shimadzu Corporation |date=19 January 2017 |archivedate=19 January 2017 |accessdate=03 February 2017 |quote=Source is actual webinar.}}</ref> 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.<ref name="YoungSome16" /><ref name="Coughlin-BogueToCombat16" /><ref name="FDAWarn16">{{cite web |url=http://www.fda.gov/newsevents/publichealthfocus/ucm484109.htm |title=2016 Warning Letters and Test Results for Cannabidiol-Related Products |work=Public Health Focus |publisher=U.S. Food and Drug Administration |date=31 August 2016 |accessdate=03 February 2017}}</ref>
| | '''(d) Compatibility''' |
| | Whenever the requirements of subsections (b) and (c) are not readily achievable, such a manufacturer or provider shall ensure that the equipment or service is compatible with existing peripheral devices or specialized customer premises equipment commonly used by individuals with disabilities to achieve access, if readily achievable.</blockquote> |
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| 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.
| | The term '''disability''' is [https://www.law.cornell.edu/uscode/text/42/12102 defined here]. You can read the full entry, but the basics are: |
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| ===Analytical aspects of cannabis===
| | <blockquote>'''(1) Disability''' The term “disability” means, with respect to an individual— |
| ====Cannabinoids====
| | :'''(A)''' a physical or mental impairment that substantially limits one or more major life activities of such individual; |
| As of mid-2015, researchers have identified 104 of the more than 750 constituents of ''Cannabis sativa'' as cannabinoids<ref name="RadwanIso15">{{cite journal |title=Isolation and pharmacological evaluation of minor cannabinoids from high-potency ''Cannabis sativa'' |journal=Journal of Natural Products |author=Radwan, M.M.; ElSohly, M.A.; El-Alfy, A.T. et al. |volume=78 |issue=6 |pages=1271-6 |year=2015 |doi=10.1021/acs.jnatprod.5b00065 |pmid=26000707 |pmc=PMC4880513}}</ref>, active chemical compounds that act in a similar way to compounds our body naturally produces, and new cannabinoids continue to be identified during cannabis research.<ref name="MudgeChemo18">{{cite journal |title=Chemometric Analysis of Cannabinoids: Chemotaxonomy and Domestication Syndrome |journal=Scientific Reports |author=Mudge, E.M.; Murch, S.J.; Brown, P.N. |volume=8 |page=13090 |year=2018 |doi=10.1038/s41598-018-31120-2}}</ref> Many of our body's cells have cannabinoid receptors capable of modulating neurotransmitter release in the brain and other areas.<ref name="WHOTheHealth16">{{cite book |url=http://www.who.int/substance_abuse/publications/cannabis/en/ |title=The health and social effects of nonmedical cannabis use |author=World Health Organization |editor=Hall, W.; Renström, M.; Poznyak, V |publisher=World Health Organization |pages=95 |year=2016 |isbn=978921510240}}</ref> 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.<ref name="RahnCannab14">{{cite web |url=https://www.leafly.com/news/cannabis-101/cannabinoids-101-what-makes-cannabis-medicine |title=Cannabinoids 101: What Makes Cannabis Medicine? |work=Leafly - Cannabis 101 |author=Rahn, B. |publisher=Leafly Holdings, Inc |date=22 January 2014 |accessdate=03 February 2017}}</ref> However, even as new strains are developed, identifying an existing strain effectively has its own set of challenges, as Mudge ''et al.'' point out: "the total [tetrahydrocannabinol] and [cannabidiol] content is not sufficient to distinguish strains [though] a combination of targeted and untargeted chemometric approaches can be used to predict cannabinoid composition and to better understand the impact of informal breeding program and selection on the phytochemical diversity of cannabis."<ref name="MudgeChemo18" />
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| 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.<ref name="KuzdzalUnrav15">{{cite journal |title=Unraveling the Cannabinome |journal=The Analytical Scientist |author=Kuzdzal, S.; Lipps, W. |issue=0915 |year=2015 |url=https://theanalyticalscientist.com/issues/0915/unraveling-the-cannabinome/ |accessdate=19 January 2017}}</ref> Some of the major cannabinoids tested for include<ref name="KuzdzalUnrav15" /><ref name="APHLGuide16">{{cite web |url=https://www.aphl.org/aboutAPHL/publications/Documents/EH-Guide-State-Med-Cannabis-052016.pdf |format=PDF |title=Guidance for State Medical Cannabis Testing Programs |author=Association of Public Health Laboratories |pages=35 |date=May 2016 |accessdate=01 February 2017}}</ref><ref name="RahnUnder14">{{cite web |url=https://www.leafly.com/news/cannabis-101/understanding-cannabis-testing |title=Understanding Cannabis Testing: A Guide to Cannabinoids and Terpenes |work=Leafly - Cannabis 101 |author=Rahn, B. |publisher=Leafly Holdings, Inc |date=09 October 2014 |accessdate=03 February 2017}}</ref>:
| | :'''(B)''' a record of such an impairment; or |
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| * '''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<ref name="NIHDelta8">{{cite web |url=https://www.cancer.gov/publications/dictionaries/cancer-drug?cdrid=485262 |title=delta-8-tetrahydrocannabinol |work=NCI Drug Dictionary |publisher=National Institutes of Health, National Cancer Institute |accessdate=08 February 2017}}</ref>) 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.
| | :'''(C)''' being regarded as having such an impairment (as described in paragraph (3)).</blockquote> |
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| * '''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.
| | The term '''readily achievable''' is [https://www.law.cornell.edu/uscode/text/42/12181 defined here]. It is defines as: |
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| * '''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.
| | <blockquote>'''(9) Readily achievable''' The term “readily achievable” means easily accomplishable and able to be carried out without much difficulty or expense. In determining whether an action is readily achievable, factors to be considered include— |
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| * '''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.
| | :'''(A)''' the nature and cost of the action needed under this chapter; |
| | :'''(B)''' the overall financial resources of the facility or facilities involved in the action; the number of persons employed at such facility; the effect on expenses and resources, or the impact otherwise of such action upon the operation of the facility; |
| | :'''(C)''' the overall financial resources of the covered entity; the overall size of the business of a covered entity with respect to the number of its employees; the number, type, and location of its facilities; and |
| | :'''(D)''' the type of operation or operations of the covered entity, including the composition, structure, and functions of the workforce of such entity; the geographic separateness, administrative or fiscal relationship of the facility or facilities in question to the covered entity.</blockquote> |
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| * '''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.
| | ===2. Rehabilitation Act of 1973, Section 508, amended ([https://www.law.cornell.edu/uscode/text/29/794d 29 U.S.C. 794d] - Electronic and information technology)=== |
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| ====Terpenes====
| | There's a government website dedicated to Section 508: [https://www.section508.gov/ https://www.section508.gov/] The related laws and polices can be [https://www.section508.gov/manage/laws-and-policies/ found here]. The intro states (italics emphasis mine): |
| 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.<ref name="HabibTesting13">{{cite web |url=http://lcb.wa.gov/publications/Marijuana/BOTEC%20reports/1c-Testing-for-Psychoactive-Agents-Final.pdf |format=PDF |title=Testing for Psychoactive Agents |author=Habib, R.; Finighan, R.; Davenport, S. |publisher=BOTEC Analysis Corp |date=24 August 2013 |accessdate=08 February 2017}}</ref><ref name="CMTLabs">{{cite web |url=http://www.cmtlaboratory.com/test-services/tests-offered/ |title=Tests Offered |publisher=CMT Laboratories |accessdate=08 February 2017}}</ref><ref name="WercShop">{{cite web |url=http://thewercshop.com/services/terpene-profiling-services/ |title=Terpene Profiling Services |publisher=The Werc Shop |accessdate=08 February 2017}}</ref> However, additional lab research goes into terpenes as they also show potentially useful pharmacological properties<ref name="HabibTesting13" /><ref name="WercShop" /><ref name="AndreCannabis16">{{cite journal |title=''Cannabis sativa'': The plant of the thousand and one molecules |journal=Frontiers in Plant Medicine |author=Andre, C.M.; Hausman, J.-F.; Guerriero, G. |volume=7 |pages=19 |year=2016 |doi=10.3389/fpls.2016.00019 |pmid=26870049 |pmc=PMC4740396}}</ref>, and they demonstrate synergies (referred to at times as the "entourage effect") with cannabinoids that largely still require further exploration.<ref name="CassidayTheHighs16" /><ref name="AndreCannabis16" /><ref name="WercShop" /><ref name="WachsbergerTerpene16">{{cite web |url=http://www.bloomcityclub.com/terpine-testing-the-future-of-cannabis-is-here/ |title=Terpene Testing: The future of Cannabis is here |author=Wachsberger, K. |work=Bloom Blog |publisher=Bloom City Club |date=02 February 2016 |accessdate=08 February 2017}}</ref> Testing for specific terpenes (discussed later) is less of a standardized practice, though it's rapidly improving.<ref name="HabibTesting13" /> Commonly tested terpenes by third-party testing labs include<ref name="WercShop" /><ref name="CMTLabs" /><ref name="AndreCannabis16" /><ref name="CassidayTheHighs16" /><ref name="RahnUnder14" /><ref name="SCLabs">{{cite web |url=http://sclabs.com/terpene-analysis/ |title=Terpene Analysis |publisher=SC Labs, Inc |accessdate=08 February 2017}}</ref>:
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| * Bisabolol
| | <blockquote>In 1998, Congress amended the Rehabilitation Act of 1973 to require Federal agencies to make their electronic and information technology (EIT) accessible to people with disabilities. The law (29 U.S.C § 794 (d)) ''applies to all Federal agencies when they develop, procure, maintain, or use electronic and information technology''. Under Section 508, agencies must give ''disabled employees and members of the public'' access to information comparable to the access available to others. |
| * Caryophyllene
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| * Cymene
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| * Humulene
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| * Limonene
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| * Linalool
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| * Myrcene
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| * Phytol
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| * Pinene
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| * Terpinolene
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| ====Contaminates====
| | The [https://www.access-board.gov/ U.S. Access Board] is responsible for developing Information and Communication Technology (ICT) accessibility ''standards'' to ''incorporate into regulations that govern Federal procurement practices.'' On January 18, 2017, the Access Board issued a final rule that updated accessibility requirements covered by Section 508, and refreshed guidelines for telecommunications equipment subject to Section 255 of the Communications Act. The final rule went into effect on January 18, 2018. |
| 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.
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| '''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.<ref name="BorelTheWild15">{{cite web |url=https://www.theatlantic.com/health/archive/2015/08/pot-marijuana-pesticide-legalization/401771/ |title=The Wild West of Marijuana Pesticides |author=Borel, B. |work=The Atlantic |publisher=The Atlantic Monthly Group |date=31 August 2015 |accessdate=09 February 2017}}</ref><ref name="ZhangNobody15">{{cite web |url=https://www.wired.com/2015/08/nobody-knows-pesticides-legal-marijuana// |title=Nobody Knows What to Do About Pesticides in Legal Marijuana |author=Zhang, S. |work=Wired |publisher=Condé Nast |date=07 August 2015 |accessdate=09 February 2017}}</ref> 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<ref name="BorelTheWild15" /><ref name="ZhangNobody15" />, and we don't have standards for pesticide application and testing.<ref name="CassidayTheHighs16" /> 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.<ref name="CassidayTheHighs16" /> That said, several classes of of pesticides are commonly applied during cannabis cultivation and can be tested for by labs<ref name="APHLGuide16" /><ref name="KuzdzalACloser16" /><ref name="FarrerTech15">{{cite web |url=https://public.health.oregon.gov/PreventionWellness/marijuana/Documents/oha-8964-technical-report-marijuana-contaminant-testing.pdf |format=PDF |title=Technical Report: Oregon Health Authority’s Process to Determine Which Types of Contaminants to Test for in Cannabis Products, and Levels for Action |author=Farrer, D.G. |publisher=Oregon Health Authority |date=December 2015 |accessdate=09 February 2017}}</ref>: | | The rule updated and reorganized the Section 508 Standards and Section 255 Guidelines ''in response to market trends and innovations in technology.'' The refresh also harmonized these requirements with other guidelines and standards both in the U.S. and abroad, including standards issued by the European Commission, ''and with the World Wide Web Consortium (W3C) Web Content Accessibility Guidelines (WCAG 2.0), a globally recognized voluntary consensus standard for web content and ICT.''</blockquote> |
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| * '''avermectins''': functions as an insecticide that is useful against mites, which are a common problem for cultivators
| | In discussing ICT, the U.S. Access Board [https://www.access-board.gov/ict/#b-summary-of-key-provisions summarized the key provisions] as such: |
| * '''carbamates''': functions as an insecticide, similar to organophosphates, but with decreased dermal toxicity and higher degradation
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| * '''organophosphates''': functions as the base of many insecticides and herbicides, valued for its easy organic bonding
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| * '''pyrethroids''': functions as the base of most household insecticides and exhibits insect repellent properties
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| | <blockquote>The Revised 508 Standards and 255 Guidelines replace the current product-based regulatory approach with an approach based on ICT functions. The revised technical requirements, which are organized along the lines of ICT functionality, provide requirements to ensure that covered hardware, software, electronic content, and support documentation and services are accessible to people with disabilities. In addition, the revised requirements include functional performance criteria, which are outcome-based provisions that apply in two limited instances: when the technical requirements do not address one or more features of ICT or when evaluation of an alternative design or technology is needed under equivalent facilitation.</blockquote> |
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| '''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.<ref name="CassidayTheHighs16" /><ref name="RomanoCannabis13">{{cite journal |url=http://www.stcm.ch/en/files/hazekamp_cann-oil_2013.pdf |format=PDF |title=Cannabis oil: Chemical evaluation of an upcoming cannabis-based medicine |journal=Cannabinoids |author=Romano, L.L.; Hazekamp, A. |volume=1 |issue=1 |pages=1–11 |year=2013}}</ref><ref name="PeachSuper14">{{cite journal |title=Supercritical carbon dioxide: A solvent like no other |journal=Journal of Organic Chemistry |author=Peach, J.; Eastoe, J. |volume=10 |pages=1878-95 |year=2014 |doi=10.3762/bjoc.10.196 |pmid=25246947 |pmc=PMC4168859}}</ref> 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'', the Oregon Health Authority's December 2015 technical report on contaminant testing of cannabis, and the Massachusetts Department of Public Health's response to public comments on cannabis testing provide helpful guidance. Listed solvents include benzene, butane, cumene, dimethoxyethane, hexane, and pentane, among others.<ref name="KuzdzalACloser16" /><ref name="APHLGuide16" /><ref name="CassidayTheHighs16" /><ref name="FarrerTech15" /><ref name="USPNF467">{{cite web |url=https://www.usp.org/sites/default/files/usp_pdf/EN/USPNF/generalChapter467Current.pdf |format=PDF |title=<467> Residual Solvents |work=United States Pharmacopeia and The National Formulary |publisher=United States Pharmacopeial Convention |date=01 July 2007 |accessdate=09 February 2017}}</ref><ref name="MDPHResponse">{{cite web |url=http://www.mass.gov/eohhs/docs/dph/quality/medical-marijuana/lab-protocols/external-comment-response-020416-final.pdf |format=PDF |title=Response to Public Comments |author=Bureau of Healthcare Safety and Quality |publisher=Massachusetts Department of Public Health |date=12 February 2016 |accessdate=14 February 2017}}</ref>
| | The full (lengthy) information about the ICT Accessibility 508 Standards and 255 Guidelines is found here: [https://www.access-board.gov/ict/ https://www.access-board.gov/ict/] |
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| | The specific software requirements that LabLynx will likely need to consider under Section 508 appear to be found in [https://www.access-board.gov/ict/#chapter-5-software Chapter 5: Software] and [https://www.access-board.gov/ict/#chapter-6-support-documentation-and-services Chapter 6: Support Documentation and Services]. (If for some reason LLX is in the hardware domain, they'll want to also consider[https://www.access-board.gov/ict/#chapter-4-hardware Chapter 4: Hardware] If you're curious about the underlying standards, you can find them in [https://www.access-board.gov/ict/#chapter-7-%C2%A0-referenced-standards Chapter 7: Referenced Standards]. |
|
| |
|
| '''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<ref name="KuzdzalACloser16" /><ref name="APHLGuide16" /><ref name="CassidayTheHighs16" /><ref name="DaleyTesting13">{{cite web |url=http://lcb.wa.gov/publications/Marijuana/BOTEC%20reports/1a-Testing-for-Contaminants-Final-Revised.pdf |format=PDF |title=Testing ''Cannabis'' for Contaminants |author=Daley, P.; Lampach, D.; Sguerra, S. |publisher=BOTEC Analysis Corp |date=12 September 2013 |accessdate=09 February 2017}}</ref>:
| | Finally, the Section 508 government website has a full Design & Develop section that may be applicable to development process: [https://www.section508.gov/develop/ https://www.section508.gov/develop/] |
|
| |
|
| * Heavy metals contribute to several health problems, including those of a neurological nature.
| | ==Additional information== |
| * 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), mercury (Hg), and nickel (Ni).
| |
|
| |
|
| | 1. The Section 508 website and its glossary mention LIMS under "[https://www.section508.gov/art/glossary/#S scientific instrument]," though only secondarily. At the end: "If a scientific instrument is integrated with a computer or a monitor, the computer (and associated operating system) and the monitor would be separate EIT deliverables, requiring their own Government Product Accessibility Templates (GPAT). If the computer included application software, this software would be another EIT deliverable requiring its own GPAT." |
| | |
| | 2. It appears some software can qualify for "a legally-defined Exception (Back Office)," as found in this example with STARLIMS and the VA: [https://www.oit.va.gov/Services/TRM/ToolPage.aspx?tid=7502 https://www.oit.va.gov/Services/TRM/ToolPage.aspx?tid=7502] |
|
| |
|
| '''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."<ref name="KuzdzalUnrav15" /> 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.<ref name="UCDavis17">{{cite web |url=http://www.ucdmc.ucdavis.edu/publish/news/newsroom/11791 |title=UC Davis study finds mold, bacterial contaminants in medical marijuana samples |publisher=UC Davis |date=07 February 2017 |accessdate=10 February 2017}}</ref>
| | 3. Some additional posts and guides that may be revealing: |
| | | * [https://www.levelaccess.com/how-do-i-determine-if-my-web-site-or-application-is-section-508-compliant/ How do I determine if my website or application is Section 508 compliant?] |
| 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.<ref name="KennardYouAre16">{{cite web |url=https://tantaluslabs.com/populace/you-are-probably-smoking-mouldy-weed-why-does-quality-assurance-matter/ |title=You are Probably Smoking Mouldy Weed - Why Does Quality Assurance Matter? |work=Populace |author=Kennard, M. |publisher=Tantalus Labs |date=02 June 2016 |accessdate=10 February 2017}}</ref> Like heavy metal testing, parallels are drawn from microbial testing guidelines and standards relating to tobacco and food, where they exist.<ref name="KennardYouAre16" /> 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.<ref name="FarrerTech15" /> Regardless, testing of some kind is still required by many U.S. states, including for organisms such as<ref name="KuzdzalUnrav15" /><ref name="APHLGuide16" /><ref name="CassidayTheHighs16" /><ref name="FarrerTech15" /><ref name="UCDavis17" /><ref name="KennardYouAre16" /><ref name="CANNAMicro14">{{cite web |url=http://www.fundacion-canna.es/en/microbiological-study-cannabis-samples |title=Microbiological study of Cannabis samples |publisher=Fundación CANNA |date=2014 |accessdate=10 February 2017}}</ref><ref name="RussoCann13">{{cite book |url=https://books.google.com/books?id=qH-2Lj9x7L4C&pg=PT457&lpg=PT457 |chapter=Chapter 30: Contaminants and Adulterants in Herbal Cannabis |title=Cannabis and Cannabinoids: Pharmacology, Toxicology, and Therapeutic Potential |author=McPartland, J.M. |editor=Russo, E.B. |publisher=Routledge |year=2013 |pages=478 |isbn=9781136614934}}</ref>:
| | * [https://ftp.cdc.gov/pub/Software/RegistryPlus/508%20Compliance/508softwareandos.doc GSA Guide For Making Software Applications and Operating Systems Accessible] (.doc file; NOTE: No date, so not sure if incorporates amended material, so be careful) |
| | | * [https://www.dhs.gov/publication/dhs-section-508-compliance-test-processes DHS Section 508 Compliance Test Processes] |
| * 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 [https://www.leafly.com/news/industry/leaflys-state-by-state-guide-to-cannabis-testing-regulations Leafly Holdings]<ref name="RoughLeaflysState">{{cite web |url=https://www.leafly.com/news/industry/leaflys-state-by-state-guide-to-cannabis-testing-regulations |title=Leafly’s State-by-State Guide to Medical Cannabis Testing Regulations |author=Rough, Lisa |work=Leafly - Industry |publisher=Leafly Holdings, Inc}}</ref> and [http://norml.org/states NORML]<ref name="NORMLStates">{{cite web |url=http://norml.org/states |title=State Info |publisher=NORML Foundation |date=2017 |accessdate=10 April 2017}}</ref> 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.
| |
| | |
| ====Sampling====
| |
| Random, representative sampling is encouraged. When dealing with solid cannabis, BOTEC Analysis recommends a "quartering" method that divides the sample into four equal parts and takes portions from opposite sections of a square-shaped arrangement of the sample. For liquid cannabis products, remembering to stir before sample collection is advised.<ref name="APHLGuide16" /> When deriving a sample from a cannabis-laden edible, the QuEChERS approach used by food safety labs for pesticide testing has practical use.<ref name="RigdonExtract16">{{cite web |url=http://blog.restek.com/?p=25790 |title=Extraction Method for Cannabinoid Analysis in Edibles: Too Much of a Good Thing |author=Rigdon, A. |work=ChromaBLOGraphy |publisher=Restek Corporation |date=12 May 2016 |accessdate=16 February 2017}}</ref> In fact, a variety of parallels have been drawn from the food and herbal medicine industries' sampling guidelines, including from the Codex Alimentarius Commission's ''CAC/GL 50-2004 General Guidelines on Sampling'' as well as various chapters of the ''United States Pharmacopeia and The National Formulary''.<ref name="APHLGuide16" /><ref name="CACGL50-2004">{{cite web |url=http://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCAC%2BGL%2B50-2004%252FCXG_050e.pdf |format=PDF |author=Codex Alimentarius Commission |title=CAC/GL 50-2004 General Guidelines on Sampling |pages=69 |accessdate=15 February 2017}}</ref> As the APHL points out, "[g]ood sampling is key to improving analytical data equivalency among organizations," and it provides a solid base for any future testing and standardization efforts.<ref name="APHLGuide16" />
| |
| | |
| Additional sampling insight can be found by examining other states' guidelines, e.g., Massachusetts' ''Protocol for Sampling and Analysis of Finished Medical Marijuana Products and Marijuana-Infused Products for Massachusetts Registered Medical Marijuana Dispensaries''.<ref name="DPHMassProto16">{{cite web |url=http://www.mass.gov/eohhs/docs/dph/quality/medical-marijuana/lab-protocols/finished-mmj/final-revised-mdph-mmj-mips-protocol.pdf |format=PDF |title=Protocol for Sampling and Analysis of Finished Medical Marijuana Products and Marijuana-Infused Products for Massachusetts Registered Medical Marijuana Dispensaries |author=Bureau of Health Care Safety and Quality |publisher=Massachusetts Department of Public Health |pages=25 |date=05 February 2016 |accessdate=17 February 2017}}</ref>
| |
| | |
| ====Cannabinoid testing====
| |
| Quantifying cannabinoids for label accuracy is a major goal of testing, though calculation and testing processes may vary slightly from state to state. Despite any differences, laboratorians generally agree that when testing for cannabinoids such as THC and CBD, as well as their respective biosynthetic precursors THCA and CBDA, the methodology used must be scrutinized. The naturally occurring THCA of cannabis isn't psychoactive; it requires decarboxylation (a chemical reaction induced by drying/heating that releases carbon dioxide) to convert itself into the psychoactive cannabinoid THC. Chemical calculations show that the process of decarboxylation results in approximately 87.7 percent of the THCA's mass converting to THC, with the other 12.3 percent bubbling off as CO<sub>2</sub> gas.<ref name="CAWhy1">{{cite web |url=http://conflabs.com/why-0-877/ |title=Why 0.877? |publisher=Confidence Analytics |date=10 February 2016 |accessdate=16 February 2017}}</ref> The problem with this in the testing domain is gas chromatography (GC) involves heating the sample solution. If you, the lab technician, require precise numbers of both THCA and THC, then GC analysis poses the risk of under-reporting THC total values.<ref name="APHLGuide16" /> As such, liquid chromatography-diode array detection (LC-DAD) may be required if a concise profile of all cannabinoids must be made, primarily because it provides environmental stability for them all during analysis. If GC is used, the analysis requires extra considerations such as sample derivatization.<ref name="APHLGuide16" /><ref name="CassidayTheHighs16" /><ref name="RigdonAccurateJuly15">{{cite web |url=http://blog.restek.com/?p=14961 |title=Accurate Quantification of Cannabinoid Acids by GC – Is it Possible? |author=Rigdon, A. |work=ChromaBLOGraphy |publisher=Restek Corporation |date=29 July 2015 |accessdate=16 February 2017}}</ref><ref name="RigdonAccurateSept15">{{cite web |url=http://blog.restek.com/?p=15135 |title=Accurate Quantification of Cannabinoid Acids and Neutrals by GC – Derivatives without Calculus |author=Rigdon, A. |work=ChromaBLOGraphy |publisher=Restek Corporation |date=09 September 2015 |accessdate=16 February 2017}}</ref>
| |
| | |
| The APHL briefly describes analysis methods of cannabinoids using both LC and GC on pages 31–32 of their May 2016 ''Guidance for State Medical Cannabis Testing Programs''. They also point to New York Department of Health - Wadsworth Center's various guidance documents (MML-300, -301, and -303) for methodologies when testing sample types other than solids, particularly using high-performance liquid chromatography photodiode array detection (HPLC-PDA).<ref name="APHLGuide16" /><ref name="MML-300">{{cite web |url=https://www.wadsworth.org/sites/default/files/WebDoc/576578963/MML-300-01.pdf |format=PDF |title=Measurement of Phytocannabinoids using HPLC-PDA, NYS DOH MML-300 |author=Division of Environmental Health Sciences, Laboratory of Organic Analytical Chemistry |publisher=New York State Department of Health |pages=34 |date=03 November 2015 |accessdate=15 February 2017}}</ref> Overall, methods used in cannabinoid testing include<ref name="APHLGuide16" /><ref name="CassidayTheHighs16" /><ref name="MML-300" /><ref name="SCCann16">{{cite web |url=http://www.sigmaaldrich.com/content/dam/sigma-aldrich/docs/Sigma-Aldrich/General_Information/1/cannabis-testing.pdf |format=PDF |title=Cannabis Testing: Quality You Can Trust |publisher=Sigma-Aldritch Co. LLC |date=2016 |accessdate=15 February 2017}}</ref><ref name="AdamsNear16">{{cite web |url=https://www.cannabisindustryjournal.com/column/near-infrared-gc-and-hplc-applications-in-cannabis-testing/ |title=Near Infrared, GC and HPLC Applications in Cannabis Testing |author=Adams, T.; Bertone, M. |work=Cannabis Industry Journal |publisher=Innovative Publishing Co. LLC |date=30 November 2016 |accessdate=15 February 2017}}</ref>:
| |
| | |
| * Fourier transform infrared spectroscopy (FTIR; has limitations, such as requiring standard samples tested w/ other methods)
| |
| * Gas chromatography flame ionization detection (GC-FID; requires sample derivatization for both acid and neutral compounds; good with standards like 5α-cholestane, docosane, and tetracosane)
| |
| * Gas chromatography mass spectrometry (GC-MS; requires sample derivatization for both acid and neutral compounds; good with standards like deuterated cannabinoids)
| |
| * High-performance liquid chromatography photodiode array detection (HPLC-PDA; stable for all forms of cannabinoids)
| |
| * High-performance liquid chromatography UV detection (HPLC-UV)
| |
| * Supercritical fluid chromatography (SFC; newer technology w/ added benefits)
| |
| * Thin-layer chromatography (TLC; older, less common technology)
| |
| * Ultra-performance chromatography (UPC; newer technology w/ added benefits)
| |
| | |
| ====Terpene testing====
| |
| Identifying and quantifying terpenes is one of the more difficult tasks facing laboratorians<ref name="CassidayTheHighs16" />:
| |
| | |
| <blockquote>Terpenes present an analytical challenge because they are nonpolar and structurally similar, and many structural isomers exist. Mass spectrometry (MS) cannot distinguish terpenes that co-elute from a GC column because many have the same molecular weight and share fragment ions.</blockquote>
| |
| | |
| Of course, types of gas chromatography work; but like cannabinoids, terpenes can degrade with the high heat of gas chromatography.<ref name="AdamsNear16" /> Combined with the problems mentioned above, highly specialized gas chromatography processes that include additional steps — such as full evaporation technique headspace gas chromatography flame ionization detection (FET-HS-GC-FID) — can be used to produce cleaner results, particularly for volatile components.<ref name="CassidayTheHighs16" /> It's less clear if high-performance liquid chromatography (HPLC) is used frequently; some entities such as Eurofins Experchem Laboratories claim HPLC works best for them<ref name="AdamsNear16" />, while others such as Restek Corporation claim the method is problematic at best.<ref name="HerringCanHP16">{{cite web |url=http://blog.restek.com/?p=33071 |title=Can HPLC-UV Be Used For Terpenes Analysis In Cannabis? |author=Herring, T. |work=ChromaBLOGraphy |publisher=Restek Corporation |date=29 December 2016 |accessdate=15 February 2017}}</ref>
| |
| | |
| Overall, methods for terpene identification and analysis include<ref name="CassidayTheHighs16" /><ref name="SCLabs" /><ref name="SCCann16" /><ref name="AdamsNear16" /><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>:
| |
| | |
| * Full evaporation technique headspace gas chromatography flame ionization detection (FET-HS-GC-FID; tends to be semi-quantitative)
| |
| * Gas chromatography flame ionization detection (GC-FID)
| |
| * Gas chromatography mass spectrometry (GC-MS)
| |
| * Headspace gas chromatography mass spectrometry (HS-GC-MS)
| |
| * High-performance liquid chromatography (HPLC; may have limitations due to coelution of terpenes and cannabinoids at certain ranges<ref name="HerringCanHP16" />) | |
| | |
| ====Contaminate testing====
| |
| [[File:LC MS pic.jpg|right|400px]]'''Pesticides''': Gas and liquid chromatography methods are by and large the staple of testing methods for pesticides, which remain "the hardest analyses that are going to be done in the cannabis industry."<ref name="CassidayTheHighs16" /> Notably, high-performance liquid chromatography tandem-mass spectrometry (HPLC-MS/MS) tends to be one of the most thorough methods says Emerald Scientific's CTO Amanda Rigdon. "Ninety-five percent of the pesticides out there can be analyzed by HPLC-MS/MS, although there are some that you would need a GC-MS/MS for," she says.<ref name="CassidayTheHighs16" /> Testing methods that have been used include<ref name="APHLGuide16" /><ref name="ShimadzuCLTS" />:
| |
| | |
| * Gas chromatography electron capture detection (GC-ECD)
| |
| * Gas chromatography mass spectrometry (GC-MS)
| |
| * Gas chromatography tandem-mass spectrometry (GC-MS/MS)
| |
| * Liquid chromatography mass spectrometry (LC-MS; also high-performance or HPLC-MS)
| |
| * Liquid chromatography tandem-mass spectrometry (LC-MS/MS; also high-performance or HPLC-MS/MS)
| |
| | |
| For quantification of pesticides in cannabis, the EPA's Residue Analytical Methods (RAM) or FDA's Pesticide Analytical Manual (PAM) provide guidance to labs.<ref name="APHLGuide16" /><ref name="FDAAnalysisofFoods11">{{cite web |url=https://archive.epa.gov/pesticides/methods/rammethods/web/html/ram12b.html |title=Residue Analytical Methods (RAM) |publisher=United States Environmental Protection Agency |date=20 February 2016 |accessdate=14 February 2017}}</ref><ref name="FDA_PAM">{{cite web |url=http://www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/ucm2006955.htm |title=Pesticide Analytical Manual (PAM) |publisher=United States Food and Drug Administration |date=07 June 2015 |accessdate=14 February 2017}}</ref>
| |
| | |
| | |
| '''Solvents''': Testing for solvents is largely standardized into a couple of options, which have parallels to existing pharmaceutical testing standards outlined in Chapter 467 of ''United States Pharmacopeia and The National Formulary'' (USP <467>)<ref name="USPNF467" /><ref name="APHLGuide16" /><ref name="CassidayTheHighs16" /><ref name="ShimadzuCLTS" />:
| |
| | |
| * Headspace gas chromatography/mass spectrometry (HS-GC/MS)
| |
| * Full evaporation technique headspace gas chromatography flame ionization detection (FET-HS-GC-FID)
| |
| | |
| Massachusetts and Oregon — and likely other states — have used a variety of guidance documents such as USP <467>, reports from the Commission of the European Communities' Scientific Committee on Food (now the European Food Safety Authority), and the International Conference on Harmonization's (ICH) Q3C(R5)<ref name="APHLGuide16" /><ref name="MDPHResponse" /><ref name="FarrerTech15" /> to set their action level testing values for particular 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<ref name="KuzdzalACloser16" /><ref name="APHLGuide16" /><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" />:
| |
| | |
| * 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)
| |
| | |
| For quantification of metals in cannabis, the U.S. FDA's ICP-MS methodology document is often used.<ref name="APHLGuide16" /><ref name="FDAAnalysisofFoods11">{{cite web |url=http://www.fda.gov/downloads/Food/FoodborneIllnessContaminants/Metals/UCM272693.pdf |format=PDF |title=Analysis of Foods for As, Cd, Cr, Hg and Pb by Inductively Coupled Plasma-Mass Spectrometry (ICP-MS) |publisher=United States Food and Drug Administration, Center for Food Safety and Applied Nutrition |date=25 April 2011 |accessdate=14 February 2017}}</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>:
| |
| | |
| * 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)
| |
| | |
| The extent of mycotoxin testing required remains in question by several entities. The Association of Public Health Laboratories (APHL) claims "[t]here is no readily available evidence to support the contention that cannabis harbors significant levels of mycotoxins."<ref name="APHLGuide16" /> The Oregon Health Authority takes a more middle-ground approach, noting that testing for ''E. coli'' and ''Salmonella'' will "protect public health," though ''Aspergillus'' only deserves a warning for people with suppressed immune systems due to its prevalence in the environment.<ref name="FarrerTech15" /> USP <561> recommendations largely limit mycotoxin testing of botanical products to those borne from root or rhizome material<ref name="USPNF561">{{cite web |url=https://hmc.usp.org/sites/default/files/documents/HMC/GCs-Pdfs/c561.pdf |format=PDF |title=<561> Articles of Botanical Origin |work=United States Pharmacopeia and The National Formulary |publisher=United States Pharmacopeial Convention |date=01 July 2007 |accessdate=15 February 2017}}</ref>, "which THC-containing cannabis products presumably do not possess," emphasizes the APHL.<ref name="APHLGuide16" /> Regardless, U.S. Pharmacopeia's Chapter 561 remains a useful document for testing guidelines and limits regarding microbials.<ref name="USPNF561" /><ref name="APHLGuide16" /> In the less common case of dealing with powdered cannabis — a relatively new THC extract form — Chapter 2023 provides at least some testing parallels, though Dr. Tony Cundell, a microbiologist consulting for the pharmaceutical industry, suggests USP <2023> doesn't go far enough for immunocompromised patients.<ref name="CundellMicro15">{{cite web |url=http://www.americanpharmaceuticalreview.com/Featured-Articles/177487-Microbiological-Attributes-of-Powdered-Cannabis/ |title=Microbiological attributes of powdered cannabis |work=American Pharmaceutical Review |author=Cundell, T. |publisher=CompareNetworks, Inc |date=31 July 2015 |accessdate=15 February 2017}}</ref>
| |
| | |
| Somewhat related and worth mentioning is moisture content testing. As previously mentioned, warm, moist environments are conducive to microorganism growth, and regularly measuring water activity is useful for the prevention of microbial growth.<ref name="FarrerTech15" /> The APHL references specifications from the Dutch Office of Medical Cannabis that recommend water content be between five to ten percent in cannabis.<ref name="APHLGuide16" />
| |
| | |
| ===Reports===
| |
| There's little in the way of standardization for lab reporting of cannabis test results, though some U.S. states have outlined requirements for what must be included in such reports. The Oregon Health Authority's ''Oregon Administrative Rules, Chapter 333, Division 64, Section 0100: Marijuana Item Sampling Procedures and Testing'' stipulates that any report must include total THC and total CBD (by dry weight) and, if discovered, "up to five tentatively identified compounds (TICS) that have the greatest apparent concentration." It also lays out requirements for pesticides, failed tests, limits of quantification, and specimen identifiers such as test batch number.<ref name="OHA333-064-0100">{{cite web |url=http://arcweb.sos.state.or.us/pages/rules/oars_300/oar_333/333_064.html |title=Oregon Health Authority, Public Health Division, Division 64, Accreditation of Laboratories |work=Oregon Administrative Rules |publisher=Oregon Secretary of State |accessdate=16 February 2017}}</ref>
| |
| | |
| In late January 2017, Pennsylvania released its temporary regulations in support of its new medical marijuana program (28 Pa. Code Chapter 1171), which includes a section on test results and reporting (1171.31). The regulations stipulate reporting by electronic tracking system, with stipulations on using certificates of analysis which include lot/batch number and the specific compounds and contaminates tested.<ref name="28PA1171">{{cite journal |url=http://www.health.pa.gov/My%20Health/Diseases%20and%20Conditions/M-P/MedicalMarijuana/Documents/Chapter%201171%20Laboratories%201-26-17.pdf |format=PDF |title=Title 28 - Health and Safety, Department of Health - 28 Pa. Code Ch. 1171 |journal=Pennsylvania Bulletin |author=Pennsylvania Department of Health |volume=46 |issue=52 |pages=8036–8041 |date=24 December 2016}}</ref> Regulations aside, it's largely up to the laboratory — and often by extension, the software they're using — to decide how a report is formatted. Some labs like Seattle-based Analytical 360 offer clean, color-based certificates of analysis, with high-magnification photographs, the chromatogram, potency, cannabinoid content, contaminate content, and explanation of limits, with the name of the approving analyst.<ref name="CC_A360">{{cite web |url=http://cannabis-chronicles.com/wp-content/uploads/Godzilla.pdf |format=PDF |title=Certificate of Analysis - Sample: Godzilla |publisher=Cannabis Chronicles |date=07 July 2014 |accessdate=16 February 2017}}</ref><ref name="C360Results">{{cite web |url=http://analytical360.com/testresults |title=Current Test Results |publisher=Analytical 360, LLC |accessdate=16 February 2017}}</ref> Others may simply generate a computer printout with the basic data and a legend.<ref name="HydrioCan16">{{cite web |url=http://beyondchronic.com/question/can-you-help-me-analyze-lab-reports-of-cannabis-oil/ |title=Can you help me analyze lab reports of cannabis oil? |author=Hydrio |work=Beyond Chronic: Ask Old Hippie |date=August 2016 |accessdate=16 February 2017}}</ref> Reports may originate from the measuring device itself (e.g., an integrator in a chromatography device), a middleware or data station attached to the instrument, or a laboratory information management system that accepted data from the instrument.<ref name="McKennaSetting15">{{cite web |url=http://www.slideshare.net/GenTechScientific/ica2015-cannabis-presentation |title=Setting Up Your Cannabis Lab for Potency Testing |author=McKenna, M. |work=SlideShare |publisher=GenTech |date=18 June 2015 |accessdate=16 February 2017}}</ref>
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| Though not directly related to laboratory testing, it's worth noting states also have their own reporting requirements for growers, processors, and dispensaries. Both Oregon and Washington, for example, require monthly reports related to medical marijuana transfers.<ref name="OMMPReporting">{{cite web |url=https://public.health.oregon.gov/DiseasesConditions/ChronicDisease/MedicalMarijuanaProgram/Pages/reporting.aspx |title=Reporting Requirements for Tracking Medical Marijuana |author=Public Health Division |publisher=Oregon Health Authority |accessdate=16 February 2017}}</ref><ref name="314-55 WAC">{{cite web |url=http://apps.leg.wa.gov/wac/default.aspx?cite=314-55&full=true |title=Chapter 314-55 WAC: Marijuana Licenses, Application Process, Requirements, and Reporting |work=Washington Administrative Code |publisher=Washington State Legislature |date=16 November 2016 |accessdate=16 February 2017}}</ref>
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| ===Lab equipment===
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| As indicated in previous sections, spectrometry and chromatography have played and will continue to play an important role in cannabis laboratory testing. This should not be surprising: "mass spectrometry is superior to other spectral techniques in such features as sensitivity, selectivity, generation possibility of molecular mass/formula, and combinability with chromatography."<ref name="MilmanTech10">{{cite book |chapter=Chapter 2: Techniques and Methods of Identification |title=Chemical Identification and its Quality Assurance |author=Milman, B.L. |publisher=Springer Berlin Heidelberg |year=2010 |pages=23–39 |isbn=9783642153617 |doi=10.1007/978-3-642-15361-7_2}}</ref> Analyzing complex chemical compounds that have many features and which are at times difficult to differentiate from each other proves challenging, but these technologies excel in meeting that task.<ref name="MilmanTech10" /> Refer to the previous "Methods and guidelines" section to note the specific technology associated with each molecule and contaminate. Aside from spectrometry and chromatography equipment, the analysis of microorganisms in cannabis may turn to DNA analysis methods that require additional equipment such as a thermal cycler (qPCR) or sequencer (WMGS), or ELISA, which utilizes a photometer or spectrophotometer. Of course, preparing and storing samples requires equipment as well, such as microplates, centrifuges, comparison standards, capillaries, chemicals, columns, Petri dishes, scales, and disposable gloves. Software-based data management systems may also constitute equipment and are discussed in the next section.
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| When it comes to purchasing lab equipment specifically for cannabis testing, a 2015 interview with Emerald Scientific's CTO Amanda Rigdon (then with Restek Corporation) provides good advice<ref name="TaylorCanna15">{{cite web |url=http://www.laboratoryequipment.com/article/2015/06/cannabis-testing-opens-whole-new-market |title=Cannabis Testing Opens Up a Whole New Market |author=Taylor, M. |work=Laboratory Equipment |publisher=Advantage Business Media |date=23 June 2015 |accessdate=17 February 2017}}</ref>:
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| * Industry-specific instrumentation isn't needed in most cases as most of the techniques and equipment used in food and herbal medicine testing have strong parallels to cannabis testing.
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| * That said, some sample preparation tools, standards, and consumables specifically marketed to the industry may very well make the job quicker and more reliable.
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| * Appropriate sample preparation techniques are just as vital as the equipment you use. | |
| * Do your research; many instrument companies are examining methodologies usable on conventional equipment, lessening the need for more expensive devices.
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| * If buying used equipment, make sure the original manufacturer is still in business and producing consumables and replacement parts. Make sure your planned methods match the equipment, and make sure it's not so old that it can't be serviced by a qualified technician.
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| ===Software===
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| Laboratories increasingly depend on software to analyze, store, and share critical data from instruments and experiments.<ref name="VI11">{{cite web |url=http://www.virtualinformatics.com/content/Laboratory_informatics.htm |archiveurl=http://web.archive.org/web/20150425070143/http://virtualinformatics.com/content/Laboratory_informatics.htm |title=Laboratory Informatics |publisher=virtualinformatics.com |date=09 April 2011 |archivedate=25 April 2015 |accessdate=17 February 2017}}</ref> This has led to the development of laboratory-specific software like the [[laboratory information management system]] (LIMS), [[electronic laboratory notebook]] (ELN), and [[chromatography data management system]] (CDMS; sometimes simply CDS). These and other software systems such as "seed-to-sale" programs can also play an important role in the cannabis testing laboratory.
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| ====LIMS====
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| Laboratories of all types use LIMS software to manage the wide variety of data, testing and analysis workflows, and other enterprise activities typical of them. This generally includes — but is not limited to — sample receipt, workflow management, sample tracking and analysis, quality control, instrument data management, data storage, reporting and document management.<ref name="SkobelevLab11">{{cite journal |title=Laboratory information management systems in the work of the analytic laboratory |journal=Measurement Techniques |author=Skobelev, D.O.; Zaytseva, T.M.; Kozlov, A.D. et al. |volume=53 |issue=10 |pages=1182–1189 |year=2011 |doi=10.1007/s11018-011-9638-7}}</ref> The cannabis testing laboratory is no exception, though its activities differ slightly from, for example, a clinical pathology laboratory. As such, a few additional features outside of what's typically found in a generic LIMS are required.
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| Features that may be incorporated into a cannabis testing LIMS that you might not necessarily find in an all-purpose LIMS include<ref name="BirosUsing15">{{cite web |url=https://www.cannabisindustryjournal.com/feature_article/using-lims-in-cannabis-laboratories/ |title=Using LIMS in Cannabis Laboratories |author=Biros, A.G. |work=Cannabis Industry Journal |publisher=Innovative Publishing Co. LLC |date=23 October 2015 |accessdate=21 February 2017}}</ref><ref name="PromiumELIMSCanna">{{cite web |url=https://www.promium.com/main/element-lims-cannabis |title=LIMS for Managing Cannabis Testing |publisher=Promium, LLC |accessdate=21 February 2017}}</ref><ref name="PharmWareHome">{{cite web |url=http://www.pharmware.net/ |title=PharmWare |publisher=PharmLabs LLC |accessdate=21 February 2017}}</ref><ref name="LLLIMSCanna">{{cite web |url=http://www.lablynxpress.com/index.php?title=LabLynx_LIMS_-_Cannabis |title=LabLynx LIMS - Cannabis |publisher=LabLynx, Inc |date=20 January 2017 |accessdate=21 February 2017}}</ref>:
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| * sample loading screens optimized for the industry, including differentiation between medical and recreational marijuana
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| * pre-loaded compliant test protocols, labels, and reports optimized and readily adjustable for a rapidly changing industry
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| * tools for creating new, compliant test protocols, labels, and reports
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| * a web API to integrate with state-required compliance reporting systems
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| * chain-of-custody (CoC) tracking, when necessary
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| * support for inventory reconciliation
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| As previously discussed, industry-specific test protocols largely focus on cannabinoids, terpenes, and a wide variety of contaminates, including excess water. However, as regulations continue to be in a state of flux and not particularly standardized, most LIMS developers are including the ability for users to adjust their protocols and even add new ones. And while CoC functionality is not entirely foreign to generic LIMS, it's particularly important in an industry where currently transporting even a cannabis test sample across state lines can create huge problems.
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| In cases where daily sample processing is infrequent and only a couple of chromatography machines are used, laboratories may weigh a decision between a LIMS and a chromatography-specific CDMS, although the ability to produce an acceptable certificate of authenticity (CoA) and document the CoC are still factors, along with any state reporting requirements.
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| ====CDMS====
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| Scientists on the research side of cannabis are certainly using CDMSs from Agilent, Thermo Scientific, Waters, and other to manage the data coming out of their chromatography equipment<ref name="PurschkeDevelop16">{{cite journal |title=Development and validation of an automated liquid-liquid extraction GC/MS method for the determination of THC, 11-OH-THC, and free THC-carboxylic acid (THC-COOH) from blood serum |journal=Analytical and Bioanalytical Chemistry |author=Purschke, K.; Heinl, S.; Lerch, O. et al. |volume=408 |issue=16 |pages=4379-88 |year=2016 |doi=10.1007/s00216-016-9537-5 |pmid=27116418 |pmc=PMC4875941}}</ref><ref name="AlbertiniDeterm15">{{cite web |url=http://tools.thermofisher.com/content/sfs/posters/PO-GC-MS-THC-Metabolites-Triple-Quad-EN.pdf |format=PDF |title=Determination of Tetrahydrocannabinol (THC) and Its Main Metabolites Using GC Triple Quadrupole Mass Spectrometry |author=Albertini, T.; Caruso, A. |publisher=Thermo Fisher Scientific |date=2015 |accessdate=17 February 2017}}</ref><ref name="LaytonAnalysis17">{{cite web |url=https://www.perkinelmer.com/lab-solutions/resources/docs/APP_Analysis-of-Cannabinoids-in-Hemp-Seed-Oils-by-HPLC-012317_01.pdf |format=PDF |title=Analysis of Cannabinoids in Hemp Seed Oils by HPLC Using PDA Detection |author=Layton, C.; Reuter, W.M. |publisher=PerkinElmer, Inc |date=23 January 2017 |accessdate=17 February 2017}}</ref>, and slowly but surely some of those CDMSs are beginning to also support spectrometer data management in a similar way.<ref name="DaviesCentral16">{{cite web |url=http://www.spectroscopyeurope.com/articles/tony-davies-column/3676-central-spectroscopic-data-systems-why-are-chromatographers-so-much-better-equipped |title=Central spectroscopic data systems: Why are chromatographers so much better equipped? |author=Davies, A.N. |work=Spectroscopy Europe |publisher=John Wiley & Sons Ltd; IM Publications LLP |date=12 April 2016 |accessdate=17 February 2017}}</ref> Additionally, some chromatography system developers will collaborate with CDMS vendors to develop software drivers — code that essentially acts as a translator between a device and a program — so chromatography devices can interact fully with the CDMS.<ref name="ShimadzuWaters">{{cite web |url=http://www.ssi.shimadzu.com/products/product.cfm?product=gcdriver |title=Waters Empower Shimadzu GC Driver Version 2 |publisher=Shimadzu Scientific Instruments |accessdate=17 February 2017}}</ref>
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| The CDMS likely has a place in the cannabis testing lab as well, though it may depend on the lab's data management needs and goals. In more complex labs with multiple instruments and significant daily processing workflows, a LIMS may make more practical sense.
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| ====Seed-to-sale====
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| The use of seed-to-sale software is an emerging trend that is only tangentially related to laboratory testing of cannabis. Rather than at testing laboratories, seed-to-sale software is found at cultivation sites, production facilities, and dispensaries, and that software is typically designed to be able to integrate with testing laboratory or other software. The goal: create a complete record of transaction, from the grown plant to the lab, producer, and seller. This sort of tracking is mandated in various ways by many U.S. states with legalization laws. "It’s there to prevent the diversion of marijuana, which the federal government still lists as a Schedule I substance, the most dangerous class of drugs," wrote Daniel Rothberg of the ''Las Vegas Sun'' in December 2015. "Tracking also ensures product safety, assists with audits and helps facilitate recalls."<ref name="RothbergSoft15">{{cite web |url=http://www.govtech.com/state/Software-Firms-Benefit-from-Governments-Seed-to-Sale-Marijuana-Tracking.html |title=Software Firms Benefit from Government’s Seed-to-Sale Marijuana Tracking |author=Rothberg, D. |work=Government Technology |publisher=e.Republic, Inc |date=29 December 2015 |accessdate=21 February 2017}}</ref> This type of software is able to track plant yields, attempted theft or diversion, patient preferences, extraction methods, batch weights, and various financial statistics for analysis.<ref name="SmythTrack16">{{cite web |url=https://mjfreeway.com/blog/track-and-trace-vs-seed-to-sale |title=Track and Trace vs. Seed to Sale |author=Smyth, H. |work=MJ Freeway Blog |publisher=MJ Freeway, LLC |date=21 June 2016 |accessdate=21 February 2017}}</ref><ref name="RothbergSoft15" />
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| ==References==
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| {{Reflist|colwidth=30em}}
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| ==Citation information for this chapter==
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| '''Chapter''': 3. Laboratory testing of cannabis
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| '''Title''': ''Past, Present, and Future of Cannabis Laboratory Testing and Regulation in the United States''
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| '''Author for citation''': Shawn E. Douglas
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| '''License for content''': [https://creativecommons.org/licenses/by-sa/4.0/ Creative Commons Attribution-ShareAlike 4.0 International]
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| '''Publication date''': November 2018
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| <!--Place all category tags here-->
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