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

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2.3 Standardization and harmonization efforts

While federal, state, and local governments wrestle with the regulatory frameworks surrounding cannabis, scientists and government officials are carrying on, doing what they can to harmonize the patchwork of regulations with emerging industry standards and guidelines. For example, state officials from Colorado, New Mexico, Oregon, and Washington teamed up to give a presentation called "State Regulatory Approaches to Cannabis Testing, Operations and Product Logistics" at the July 2016 Cannabis Quality, Strategies and Solutions Summit. That presentation focused on the harmonization of regulatory standards and frameworks across states, as well as discussions of what scientific efforts are required to support those standards and frameworks.[1] 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.[2][3][4][5][6][7] As MJBizDaily contributor Omar Sacirbey notes[8]:

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

More notable among those organizations is the Foundation of Cannabis Unified Standards (FOCUS), which worked to produce internationally applicable voluntary consensus standards for various parts of the cannabis business chain, including cultivation, extraction, laboratory testing, and packaging. FOCUS completed its public review process and finalized its standards in July 2016, though at that time it wasn't clear how to gain access to them.[9] New information came to light in March 2017, when FOCUS and ASTM International announced a collaboration between the two entities, which in April 2017 saw the formation of volunteer committee D37 at ASTM and the further adaptation of FOCUS' standards to future ASTM releases.[10][11]

The newly formed Committee D37 agreed to pursue cannabis standardization in six key areas[12][13]:

  • indoor and outdoor horticulture and agriculture: e.g., pest management, water considerations, environmental site assessment, and sustainability
  • quality management systems: e.g., quality considerations, due diligence
  • laboratory testing: e.g., sampling, stability testing, purity testing, analytical methods, and proficiency testing
  • processing and handling: e.g., drying and curing, exposure management, waste management, storage
  • security and transportation: e.g., packaging, shipping management, risk assessment and mitigation, occupational health and safety
  • training, assessment, and credentialing: e.g., laboratory training, clean room management, quality inspection, patient and physician education

Since its founding in April 2017, Committee D37 has made strides towards its goals. Meeting every January and June[11], D37 has made progress on developing several standards and creating a set of standardized terminology to be used across them.[14] Its first two approved standards arrived in May 2018, concerning testing methods for determining water activity in cannabis samples, as well as the range of water activity that is "safe and effective" for storing samples.[15] In August 2018, the committee announced a new standards project that would result in two guides that "will provide sampling procedures critical in generating accurate laboratory results, which in turn could lead to improved consumer safety."[16] By October 2018, ASTM Committee D37 had agreed to work with the International Cannabis and Cannabinoids Institute (ICCI) to mutually develop standards for the cannabis industry.[17] Since then, a variety of other standards have been developed through the cooperative agreement, including standards for analytical laboratory operations, laboratory test method development and validation, stability testing, and sampling.[18]

In addition to ASTM's Committee D37, the AOAC and its Cannabis Analytical Science Program (CASP) has also been recently active in developing standards for cannabis laboratory testing. In August 2018, the AOAC's CASP finalized its first "Standard Method Performance Requirement" or "SMPR," which is a set of "minimum recommended performance characteristics to be used during the evaluation of a method." Within the AOAC, they're also used for the "evaluation of validation study data for method[s] being considered for Performance Tested Methods or AOAC Official Methods of Analysis." The first SMPR addressed identifying and quantifying pesticides in dried cannabis materials.[19] In September 2019, they approved an SMPR (2019.003) for analyzing cannabinoids in hemp (i.e., low THC cannabis varieties). This was followed up a month later by the release of an SMPR for determining residual solvents in cannabis derivatives, as well as one for detecting the Aspergillus fungus in cannabis.[20] (The USDA has reportedly adopted the AOAC's cannabinoid testing standard as part of its Domestic Hemp Production Program, further cementing the standard into more common use.[20]) The AOAC has also worked to get additional analytical methods published in academic journals, including one for "Determination of Cannabinoids in Cannabis sativa Dried Flowers and Oils by LC-UV"[21] and another for "Quantitation of Cannabinoids in Cannabis Dried Plant Materials, Concentrates, and Oils Using Liquid Chromatography-Diode Array Detection Technique with Optional Mass Spectrometric Detection."[22] And the CASP set a goal to develop and adopt an additional six cannabis- or hemp-based SMPRs, as well as several official methods, by the end of 2020.[23] As of July 2022, thirteen SMPRs for cannabis have been released, with two additional ones concerning heavy metal and cannabinoid quantitation in beverage in draft status.[24]

Also of note is the National Institute of Standards and Technology (NIST) Cannabis Quality Assurance Program (CannaQAP). Launched in July 2020, the CannaQAP "aims to increase accuracy in product labeling and help forensic laboratories distinguish between hemp, which is legal in all states, and marijuana, which is not."[25][26] Similar in vein to The Emerald Test[27], NIST uses a proficiency test approach, though without the pass-fail grade, allowing participating labs to improve their analytical methods based off the most successful methods.[25][26] It's possible efforts like these will further lead to more standardized approaches to testing cannabis constituents and contaminants.

Finally, the Cannabis Regulators Association (CANNRA) is another recent non-profit entity working to harmonize regulations and standards across the industry. Formed in November 2020, CANNRA was "created in order to assist federal, state, and local jurisdictions that have approved or are weighing legalization of cannabis" and "engage with each other to identify and develop best practices, create model policies that safeguard public health and safety, and promote regulatory certainty for industry participants."[28] Since its creation, regulators from more than 40 states, jurisdictions, and territories have eventually joined "to foster harmony and, where possible, standardization across jurisdictions that legalize and regulate cannabis."[8][29] The organization has not only highlighted regulatory issues such as lack of standardization of laboratory testing across U.S. states[30], but it also has submitted responses to draft legislation requests for comments and written letters to government officials encouraging stances on matters related to the industry[31] (though the association notes that it's "not a cannabis advocacy group"[30]).

2.3.1. Enforcement

While this harmonization of regulations, standards, and accreditation requirements is a worthy effort, downstream enforcement efforts will eventually need to be just as durable to ensure harmonization efforts aren't for not.[8] The importance of enforcement is expressed in a June 2022 "Notice of Proposed Rulemaking" by the Department of Cannabis Control (DCC) of California. The proposed rules would standardize lab testing methods across the entire state "so there is greater integrity in the market, accurate information for consumers, and confidence among stakeholders."[32] The DCC says this of enforcement of the proposed test method requirements[33]:

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

This focus on enforcement is noteworthy in light of their announcement and request for comments, noting that "[t]he regulatory package comes on the heels of concerns about cannabis potency inflation and 'laboratory shopping,' by cannabis businesses looking to secure THC levels that may be higher than what is actually contained in the cannabis flower or product."[32] This issue of laboratory shopping and labs bending the rules to gain more clientele is not isolated to California, as other states like Washington and Alaska have also experienced such issues.[8][34][35][36][37] As such, consistency in laboratory testing through harmonized methods will also require a similarly "harmonized" consistency in enforcing the use of those methods. As Straight Line Analytics founder James MacRae notes, "You put consequences on the labs, and you start assessing ... This is something that can be done fairly inexpensively and involves random off-the-shelf testing."[8]


  1. "Cannabis Quality, Strategies and Solutions Summit - Agenda" (PDF). Information Forecast, Inc. July 2016. Archived from the original on 02 February 2017. Retrieved 08 July 2022. 
  2. "New Certification Program Brings Quality Assurance to the Medical Marijuana Industry". Information Forecast, Inc. 2016. Retrieved 08 July 2022. 
  3. Cannabis Committee, AHPA (2 February 2016). "Recommendations for Regulators – Cannabis Operations" (PDF). American Herbal Products Association. Retrieved 08 July 2022. 
  4. Upton, R.; Craker, L.; ElSohly, M. et al., ed. (2014). Cannabis Inflorescence: Cannabis spp.. American Herbal Pharmacopoeia. ISBN 1929425333. 
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  9. "Public Review Completes Development Process". FOCUS. 2016. Retrieved 08 July 2022. 
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  19. Association of Official Agricultural Chemists (26 August 2018). "AOAC SMPR 2018.011 - Standard Method Performance Requirements (SMPRs) for Identification and Quantitation of Selected Pesticide Residues in Dried Cannabis Materials" (PDF). Retrieved 08 July 2022. 
  20. 20.0 20.1 Association of Official Agricultural Chemists (12 November 2019). "New guidelines require laboratories to meet AOAC Standard Method Performance Requirements for Quantitation of Cannabinoids in Hemp". AOAC News. Retrieved 08 July 2022. 
  21. Mudge, E.M.; Brown, P.N. (2020). "Determination of Cannabinoids in Cannabis sativa Dried Flowers and Oils by LC-UV: Single-Laboratory Validation, First Action 2018.10". Journal of AOAC International 103 (2): 489–93. doi:10.5740/jaoacint.19-0197. PMID 31561754. 
  22. Vaclavik, L.; Benes, F.; Fenclova, M. et al. (2019). "Quantitation of Cannabinoids in Cannabis Dried Plant Materials, Concentrates, and Oils Using Liquid Chromatography-Diode Array Detection Technique with Optional Mass Spectrometric Detection: Single-Laboratory Validation Study, First Action 2018.11". Journal of AOAC International 102 (6): 1822-1833. doi:10.5740/jaoacint.18-0426. PMID 31208494. 
  23. Association of Official Agricultural Chemists (November 2019). "CASP 2020 Member Prospectus" (PDF). Archived from the original on 25 February 2020. Retrieved 08 July 2022. 
  24. "Resources, Uploads, & Archives: Cannabis SMPRs". Association of Official Agricultural Chemists. Retrieved 08 July 2022. 
  25. 25.0 25.1 "NIST to Help Labs Achieve Accurate THC, CBD Measurements". National Institute of Standards and Technology. 21 July 2020. Retrieved 08 July 2022. 
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