Significance and Use
4.1 Significance:
4.1.1 This guide establishes an approach for conducting a toxicological risk-based assessment of non-cannabinoid ingredients designed to reduce the potential health risks when used in cannabinoid products intended for vaporization.
4.1.2 This guide helps to reduce consumer health risks when using products that contain non-cannabinoid ingredients that are not currently regulated in most jurisdictions.
4.1.3 This guide can aid in reducing product risk for consumers while maintaining consumer access to a wide variety of cannabinoid-containing vaporization products.
4.1.4 This guide will help to guide regulators and manufacturers in prioritizing non-cannabinoid ingredients used in consumer products containing cannabinoids intended for vaporization for additional evaluation.
4.1.5 This guide can assist regulators and manufacturers in minimizing instances when a restricted substance is replaced with a potentially more hazardous substance by performing a risk assessment of all options and understanding their unique acceptable daily inhalation limit.
4.1.6 When this guide is applied to product manufacturing it can improve consumer confidence in cannabinoid-containing products intended for vaporization.
4.2 Use:
4.2.1 This guide is ONLY intended to be used to reduce potential negative consumer health risks from vaping non-cannabinoid ingredients.
4.2.2 This guide is NOT to be used to identify a non-cannabinoid ingredient or cannabinoid product as being safe for inhalation. Following this guide does not give the authority to claim a non-cannabinoid ingredient or cannabinoid product is safe for inhalation.
4.2.3 This guide is intended to only be used to evaluate one non-cannabinoid ingredient at a time.
4.2.4 This guide is intended to be utilized to conduct a risk assessment of non-cannabinoid ingredients regardless of whether the cannabinoids in the product have been botanically-derived, produced through precision fermentation, or manufactured in a lab.
4.2.5 This guide is intended to be utilized in conjunction with an acceptable daily inhalation limit calculator which includes conservative uncertainty factors and appropriate correction factors for the selected POD or TTC.
4.2.6 Manufacturers can utilize this guide to conduct a first-pass assessment of non-cannabinoid ingredients used in their products.
4.2.7 Regulators can use the methodologies outlined in this guide and complementary standards for deriving individual ingredient limits. Using this guidance, state regulators will have a scientific process to create restrictions that can reduce consumer health risks and encourage legal cannabinoid-containing product manufacturers and consumers to stay in the regulated market.
4.2.8 This guide is intended to be used with the current body of literature and as new scientific data becomes available.
4.2.9 Although not advised, this guide can be used by a consumer to conduct their own risk assessment related to cannabinoid-containing products intended for vaporizer.
4.2.10 It is the responsibility of the user to understand the concepts presented in this guide and to utilize them appropriately.
Scope
1.1 This guide is not meant to classify the non-cannabinoid ingredient or final product as safe for inhalation. Inhaling anything other than clean air poses an inherent human health risk.
1.2 This guide shall cover all formulated (manufactured) cannabinoid-containing products intended for vaporization regardless of the method of obtention (source) of the cannabinoids used in the product.
1.3 This guide shall cover all formulated (manufactured) cannabinoid-containing products intended for vaporization regardless of whether the cannabinoids can be classified as intoxicating.
1.4 This guide shall cover all formulated (manufactured) cannabinoid-containing products intended for vaporization regardless of the regulatory classification of the consumer product.
1.5 This guide shall cover all non-cannabinoid ingredients, regardless of the method of obtention (source), used in formulated (manufactured) cannabinoid-containing products intended for vaporization.
1.5.1 Because naturally-derived and synthetic compounds produce comparable biological effects, so long as their chemical structure and spatial orientation are identical, the method of obtention (source) of the compound is irrelevant to the need to conduct a toxicological risk assessment of the non-cannabinoid ingredients.
1.6 This guide includes considerations for thermal breakdown products of the non-cannabinoid ingredient through the process of aerosolization via vaporization device usage.
1.7 This guide excludes formulated (manufactured) cannabinoid-containing products intended for combustion as well as dry herbal materials and inhalers (for example, dry powder and metered-dose).
1.8 This guide excludes the cannabinoids themselves.
1.8.1 Exclusion does not mean risk assessment of cannabinoids is unnecessary or that they are risk-free, only that they are beyond the scope of this standard. Investigation into these areas is encouraged to expand knowledge and safety of cannabinoid-containing products.
1.9 This guide excludes impurities and contaminants within the non-cannabinoid ingredients that are otherwise regulated. It is the responsibility of the user of this standard to know the impurities and contaminants and action limits set by the AHJ.
1.10 This guide excludes interactions between the compounds in the cannabinoid-containing product intended for vaporization. Interaction may include chemical interactions between two or more substances that might form new substances. Interactions may also include biological interactions such as a terpene altering cannabinoid binding to a receptor or other types of pharmacokinetic or pharmacodynamic or toxicokinetic or toxicodynamic interactions.
1.10.1 Exclusion does not mean risk assessment of interactions between compounds in the cannabinoid-containing product intended for vaporization are unnecessary or that they are risk-free, only that they are beyond the scope of this standard. Investigation into these areas is encouraged to expand knowledge and safety of cannabinoid-containing products.
1.11 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.12 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
