Book:LIMS Buyer’s Guide for Cannabis Testing Laboratories/Cannabis testing and research: An overview/Regulation and standardization of cannabis testing

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1.2 Regulation and standardization of cannabis testing

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On October 27, 1970, the Controlled Substances Act put into place five schedules or classifications of drugs that would be regulated in some fashion, and drugs were initially classified into those schedules, followed by annual reviews and updates.[1] Marijuana was initially placed under Schedule I[1] and remains there today.[2][3][4] As a Schedule I drug, the federal government is indicating marijuana has[1]:

  • "a high potential for abuse";
  • "no currently accepted medical use in treatment in the United States"; and
  • "a lack of accepted safety for use of the drug or other substance under medical supervision".

Then came the Reorganization Plan No. 2 of 1973, which took existing enforcement entities such as the Bureau of Narcotics and Dangerous Drugs and placed them into a new, unified entity called the Drug Enforcement Administration (DEA).[5][6] Then President Richard Nixon said of the transition[5]:

The enforcement work could benefit significantly, however, from consolidation of our anti-drug forces under a single unified command. Right now the Federal Government is fighting the war on drug abuse under a distinct handicap, for its efforts are those of a loosely confederated alliance facing a resourceful, elusive, worldwide enemy.

The DEA was given numerous responsibilities, including but not limited to the development of enforcement strategy; investigation and prosecution preparation of suspects violating federal law; regulation of drugs and other controlled substances; and coordination and cooperation with state and local government drug enforcement efforts.[5] Since then the DEA has taken various steps—with guidance from the Food and Drug Administration (FDA)[7]—to regulate and enforce the availability and use of controlled substances such as marijuana. As the decriminalization and legalization efforts of states have increased in past decades, this has brought federal regulation and enforcement conflicts to those states that have decriminalized and legalized, largely due to the federal government's insistence on maintaining marijuana as a Schedule I drug.[8][9]

Numerous changes in federal policy, as well as a few controversies, have occurred since the Controlled Substance Act and DEA were implemented. This includes:

  • 2009's Ogden Memorandum, "intended solely as a guide to the exercise of investigative and prosecutorial discretion" in regards to state-based laws allowing medical cannabis[10];
  • 2011's Cole Memorandum 1, underlining that while the stance of the Ogden Memo still stood, large grow-ops that didn't qualify as "caregivers" had sprung up since, requiring federal enforcement action[11];
  • 2013's Cole Memorandum 2, which sought to reduce the emphasis on the size of the grow-op and increase emphasis on—using a case-by-case basis—"whether the operation is demonstrably in compliance with a strong and effective state regulatory system"[12];
  • 2014 and onward's Rohrabacher-Farr/Joyce Amendments, prohibiting the DoJ from spending funds to prevent or enforce against state laws that allow for medical marijuana cultivation, distribution, and use, particularly when those actions are performed consistently with those state laws[13];
  • 2016's DEA denial of a petition to reschedule marijuana out of Schedule I, while recognizing the need for further research and the lack of legal marijuana sources for researchers[2][14];
  • 2018 Farm Bill, which removed industrial hemp from the Controlled Substance Act's definition of "marijuana" and struck it from Schedule I[15];
  • 2020's House Health Subcommittee meetings, the first of their kind, to discuss cannabis research and cannabis' current scheduling, as well as the problems that come from it[16]; and
  • 2020's MORE Act, a continuing effort which would decriminalize "marijuana at the federal level while enabling states to set their regulatory policies without the threat of federal intervention."[17]

At the state level, changing laws and regulation have continued to put pressure on cannabis law at the federal level. As of July 2021, thirty-seven U.S. states and the District of Columbia have put some sort of broad decriminalization or legalization laws for cannabis on the books.[18] 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.[19] 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.[20][21] 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.[20] Colorado, Maine, Massachusetts, and Nevada followed suit in 2016[22], with Michigan doing the same in 2018.[23]

As shown by Cambron et al. in 2016[20], dispensaries, possession limits, and interstate ID card acceptance can vary significantly among affected states. California, Colorado, Michigan, Oregon, and Washington led in number of dispensaries; Massachusetts, Oregon, and Washington in maximum possession limits; and Arizona plus five others allowed ID cards from other states. Yet the number of allowed dispensaries can be 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.[20]

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[24]:

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.

This variation in law also largely mirrors the variation found in laboratory testing methods of cannabis and its constituents. Recognizing this variance in standards and methods, 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.[25] Additionally, organizations such as Americans for Safe Access Foundation (ASAF), American Herbal Pharmacopoeia (AHP), American Herbal Products Association (AHPA), Association of Official Agricultural Chemists (AOAC), and the American Oil Chemists' Society (AOCS) have been developing standards, methods, and certifications for analysis, extraction, labeling, and laboratory operations surrounding medical (and recreational) marijuana.[26][27][28][29][30][31] More recent efforts from the Foundation of Cannabis Unified Standards (FOCUS), ASTM International, the AOAC's Cannabis Analytical Science Program (CASP), and the National Institute of Standards and Technology (NIST) have, however, furthered attempts to standardize cannabis laboratory testing.[32][33][34][35][36]

References

  1. 1.0 1.1 1.2 "§812. Schedules of controlled substances". United States Code. U.S. Government Publishing Office. 3 January 2012. https://www.govinfo.gov/content/pkg/USCODE-2011-title21/html/USCODE-2011-title21-chap13-subchapI-partB-sec812.htm. Retrieved 07 July 2021. 
  2. 2.0 2.1 Leger, D.L. (11 August 2016). "Marijuana to remain illegal under federal law, DEA says". USA. Today. Gannett Company. https://www.usatoday.com/story/news/2016/08/11/dea-marijuana-remains-illegal-under-federal-law/88550804/. Retrieved 08 July 2022. 
  3. Joseph, A. (10 August 2016). "DEA decision keeps major restrictions in place on marijuana research". STAT. Boston Globe Media. https://www.statnews.com/2016/08/10/marijuana-medical-research-dea/. Retrieved 08 July 2022. 
  4. Grubbs, A. (13 August 2016). "DEA Declines Request to Reclassify Marijuana, Citiing Its 'High Potential for Abuse'". CNSNews. Media Research Center. https://www.cnsnews.com/news/article/alex-grubbs/dea-declines-request-reclassify-marijuana-citiing-its-high-potential-abuse. Retrieved 07 July 2021. 
  5. 5.0 5.1 5.2 "Reorganization Plan No. 2 of 1973". United States Code. U.S. Government Publishing Office. 3 January 2012. https://www.govinfo.gov/content/pkg/USCODE-2011-title5/html/USCODE-2011-title5-app-reorganiz-other-dup96.htm. Retrieved 07 July 2021. 
  6. p 30-39.pdf "Drug Enforcement Administration: 1970–1975" (PDF). DEA History In Depth. U.S. Drug Enforcement Administration. https://www.dea.gov/sites/default/files/2018-07/1970-1975 p 30-39.pdf. Retrieved 07 July 2021. 
  7. Hamilton, K. (27 June 2016). "The FDA told the DEA whether pot is medicine — but it won't tell the public". Vice News. Vice Media, LLC. https://www.vice.com/en/article/pa443y/dea-fda-marijuana-schedule-1-status-decision. Retrieved 07 July 2021. 
  8. Romza-Kutz, D.; Roth V., F. (15 August 2016). "The silver lining in the DEA’s refusal to reclassify cannabis". Tracking Cannabis. Thompson Coburn LLP. https://www.thompsoncoburn.com/insights/blogs/tracking-cannabis/post/2016-08-15/the-silver-lining-in-the-dea-s-refusal-to-reclassify-cannabis. Retrieved 08 July 2022. 
  9. Hudak, J. (20 June 2015). "The Conflict Between Federal and State Marijuana Laws Claims a Victim". Newsweek. Newsweek, LLC. https://www.newsweek.com/conflict-between-federal-and-state-marijuana-laws-claims-victim-345099. Retrieved 07 July 2021. 
  10. Ogden, D.W. (19 October 2009). "Memorandum for Selected United State Attorneys on Investigations and Prosecutions in States Authorizing the Medical Use of Marijuana". Justice Blogs. Department of Justice. https://www.justice.gov/archives/opa/blog/memorandum-selected-united-state-attorneys-investigations-and-prosecutions-states. Retrieved 07 July 2021. 
  11. Cole, J.M. (29 June 2011). "Memorandum for United States Attorneys" (PDF). Department of Justice. https://www.justice.gov/sites/default/files/oip/legacy/2014/07/23/dag-guidance-2011-for-medical-marijuana-use.pdf. Retrieved 07 July 2021. 
  12. Cole, J.M. (29 August 2013). "Memorandum for All United States Attorneys" (PDF). Department of Justice. https://www.justice.gov/iso/opa/resources/3052013829132756857467.pdf. Retrieved 07 July 2021. 
  13. Armentano, P. (16 December 2014). "President Signs Federal Spending Bill Protecting State Sanctioned Medical Marijuana Programs". NORML Blog. NORML Foundation. https://norml.org/blog/2014/12/16/president-to-sign-federal-spending-bill-protecting-state-sanctioned-medical-marijuana-programs/. Retrieved 07 July 2021. 
  14. "Applications To Become Registered Under the Controlled Substances Act To Manufacture Marijuana To Supply Researchers in the United States". Federal Register 81 (156): 53846–8. 2016. https://www.federalregister.gov/documents/2016/08/12/2016-17955/applications-to-become-registered-under-the-controlled-substances-act-to-manufacture-marijuana-to. Retrieved 07 July 2021. 
  15. Cohen, B.; Bleicher, M.C.; Fortier, D.L. et al. (31 December 2018). "What Does the 2018 Farm Bill Mean for the Hemp and CBD Businesses?". Perkins Coie LLP. https://www.perkinscoie.com/en/news-insights/what-does-the-2018-farm-bill-mean-for-the-hemp-and-cbd-businesses.html. Retrieved 07 July 2021. 
  16. Norwinski, E.J.; Landgraf, L.C.; Blackwood, K. et al. (10 February 2020). "United States: Recent Congressional Efforts To Address The Cannabis Policy Gap". Mondaq. https://www.mondaq.com/unitedstates/Cannabis-Hemp/891270/Recent-Congressional-Efforts-To-Address-The-Cannabis-Policy-Gap. Retrieved 07 July 2021. 
  17. "House Passes Legislation to Make Small Businesses in Cannabis Industry Eligible for SBA Lending Programs". Committee News. Small Business Administration. 4 December 2020. https://smallbusiness.house.gov/news/documentsingle.aspx?DocumentID=3480. Retrieved 07 July 2021. 
  18. Berke, J.; Gal, S.; Lee, Y.J. (6 January 2021). "Marijuana legalization is sweeping the US. See every state where cannabis is legal". Business Insider. Insider, Inc. https://www.businessinsider.com/legal-marijuana-states-2018-1. Retrieved 08 July 2022. 
  19. Single, E.W. (1981). "The Impact of Marijuana Decriminalization". In Israel, Y.; Glaser, F.B.; Kalant, H. et al.. Research Advances in Alcohol and Drug Problems. Springer US. pp. 405–424. doi:10.1007/978-1-4615-7740-9_12. ISBN 9781461577409. 
  20. 20.0 20.1 20.2 20.3 Cambron, C.; Guttmannova, K.; Fleming, C.B. (2017). "State and National Contexts in Evaluating Cannabis Laws: A Case Study of Washington State". Journal of Drug Issues 47 (1): 74–90. doi:10.1177/0022042616678607. 
  21. "Election Summary Report, State of Alaska 1998 General Election: Official Results". Election Results. State of Alaska Division of Elections. 1 December 1998. https://www.elections.alaska.gov/results/98GENR/results.htm. Retrieved 07 July 2021. 
  22. Burke, C. (4 January 2017). "Four More States Pass New Marijuana Laws: California, Maine, Massachusetts, Nevada". National Law Review. National Law Forum, LLC. https://www.natlawreview.com/article/four-more-states-pass-new-marijuana-laws-california-maine-massachusetts-nevada. Retrieved 07 July 2021. 
  23. Chappell, B. (7 November 2018). "Voters Relax Marijuana Laws In 3 More States: Michigan, Utah, Missouri". NPR. https://www.npr.org/2018/11/07/665161814/3-more-states-ok-easing-their-marijuana-laws-michigan-utah-missouri. Retrieved 07 July 2021. 
  24. Association of Public Health Laboratories (May 2016). "Guidance for State Medical Cannabis Testing Programs" (PDF). pp. 35. https://www.aphl.org/aboutAPHL/publications/Documents/EH-Guide-State-Med-Cannabis-052016.pdf. Retrieved 07 July 2021. 
  25. "Cannabis Quality, Strategies and Solutions Summit - Agenda" (PDF). Information Forecast, Inc. July 2016. Archived from the original on 02 February 2017. https://web.archive.org/web/20170202183410/http://chernislaw.com/news/wp-content/uploads/2016/07/NEW-Cannabis-Quality-Summit-Main-Summit-Agenda.pdf. Retrieved 07 July 2021. 
  26. "New Certification Program Brings Quality Assurance to the Medical Marijuana Industry". Information Forecast, Inc. 2016. https://infocastinc.com/market-insights/new-certification-program-brings-quality-assurance-to-the-medical-marijuana-industry/. Retrieved 07 July 2021. 
  27. Cannabis Committee, AHPA (2 February 2016). "Recommendations for Regulators – Cannabis Operations" (PDF). American Herbal Products Association. https://www.ahpa.org/Portals/0/pdfs/AHPA_Recommendations_for_Regulators_Cannabis_Operations.pdf. Retrieved 07 July 2021. 
  28. Upton, R.; Craker, L.; ElSohly, M. et al., ed. (2014). Cannabis Inflorescence: Cannabis spp.. American Herbal Pharmacopoeia. ISBN 1929425333. https://herbal-ahp.org/online-ordering-cannabis-inflorescence-qc-monograph/. 
  29. Project CBD; Marcu, J. (16 March 2016). "Jahan Marcu: Cannabis Lab Testing & Safety Protocols". Project CBD. Project CBD. https://www.projectcbd.org/industry/cannabis-lab-testing-safety-protocols. Retrieved 07 July 2021. 
  30. Erickson, B.E. (13 November 2017). "Cleaning up cannabis". Chemical & Engineering News. American Chemical Society. https://cen.acs.org/articles/95/i45/Cleaning-cannabis.html. Retrieved 07 July 2021. 
  31. Cassiday, L. (October 2016). "The Highs and Lows of Cannabis Testing". INFORM. American Oil Chemists' Society. https://www.aocs.org/stay-informed/inform-magazine/featured-articles/the-highs-and-lows-of-cannabis-testing-october-2016. Retrieved 07 July 2021. 
  32. Biros, A.G. (2 March 2017). "ASTM International Launches Cannabis Committee". Cannabis Industry Journal. Innovative Publishing Co. LLC. https://cannabisindustryjournal.com/news_article/astm-international-launches-cannabis-committee/. Retrieved 07 July 2021. 
  33. "Committee D37 on Cannabis". ASTM International. 7 July 2021. https://www.astm.org/COMMITTEE/D37.htm. 
  34. Association of Official Agricultural Chemists (November 2019). "CASP 2020 Member Prospectus" (PDF). Archived from the original on 25 February 2020. https://web.archive.org/web/20200225173719/https://www.aoac.org/wp-content/uploads/2019/11/CASP-Prospectus-2020.-11_25.pdf. Retrieved 07 July 2021. 
  35. "NIST to Help Labs Achieve Accurate THC, CBD Measurements". National Institute of Standards and Technology. 21 July 2020. https://www.nist.gov/news-events/news/2020/07/nist-help-labs-achieve-accurate-thc-cbd-measurements. Retrieved 07 July 2021. 
  36. "NIST Tools for Cannabis Laboratory Quality Assurance". National Institute of Standards and Technology. May 2019. https://www.nist.gov/programs-projects/nist-tools-cannabis-laboratory-quality-assurance. Retrieved 07 July 2021.