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

2.3 Standardization

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 those 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. 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 [[Cannabis (drug)|medical] (and recreational) marijuana.

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. 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.

The newly formed Committee D37 agreed to pursue cannabis standardization in six key areas:

• 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, D37 has made progress on developing several standards and creating a set of standardized terminology to be used across them. 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. 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." 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. Since then a variety of other standards have been developed through the cooperative agreement, with more standards in the preparation phase, including standards for determining cannabinoid concentrations, residual solvents, and pesticide amounts.

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. 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. (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.) 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 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. 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.

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." Similar in vein to The Emerald Test, 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. It's possible efforts like these will further lead to more standardized approaches to testing cannabis constituents and contaminants.