Significance and Use
4.1 Significance:
4.1.1 This practice provides a means of extrapolating non-cannabinoid ingredient consumption limits from various sources of data to human inhalation consumption limits.
4.1.2 This practice provides an easy to understand equation for calculating the acceptable daily inhalation limit of a non-cannabinoid ingredient under investigation, and breaks down the variables necessary to perform the calculations and their purpose.
4.1.3 When this practice is applied to product manufacturing it can improve consumer confidence in cannabinoid products and non-cannabinoid ingredients intended for vaporization.
4.1.4 This practice can aid manufacturers in reducing the potential health risks associated with their products while maintaining consumer access to a wide variety of cannabinoid-containing vaporization products.
4.1.5 This practice, when combined with an appropriate risk assessment, will help to direct regulators and manufacturers in prioritizing non-cannabinoid ingredients used in consumer products containing cannabinoids intended for vaporization for additional evaluation to reduce consumer health risks by focusing their efforts and limited resources on substances more likely to pose a toxicological risk.
4.2 Use:
4.2.1 This practice is ONLY intended to be used to reduce potential negative consumer health risks from vaping non-cannabinoid ingredients.
4.2.2 This practice is NOT to be used to identify a non-cannabinoid ingredient or cannabinoid product as being safe for inhalation. Following this practice does not give the authority to claim a non-cannabinoid ingredient or cannabinoid product is safe for inhalation.
4.2.3 This practice is intended to be conducted in consultation with an experienced toxicologist.
4.2.4 This practice is not intended to be used for calculating the acceptable daily inhalation limit from a lethal dose (for example, LC50 or LD50), or from data generated in vitro.
4.2.5 This practice can be used to reduce consumer health risks based on information available today for non-cannabinoid ingredients used in cannabinoid products intended for vaporization.
4.2.6 This practice can be used to calculate the most conservative acceptable daily inhalation limit for a non-cannabinoid ingredient under investigation.
4.2.7 Regulators can use this practice in combination with an appropriate risk assessment for deriving individual ingredient limits. Using this practice, state regulators will have a scientific tool to create restrictions that can provide protection to consumers and encourage legal cannabinoid-containing product manufacturers and consumers to stay in the regulated market.
4.2.8 It is the responsibility of the user to understand the concepts presented in this document and to utilize them appropriately.
Scope
1.1 This practice 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 practice shall outline the steps for calculating the acceptable daily inhalation limit from a point of departure (POD) for a non-cannabinoid ingredient intended for use in a cannabinoid product for vaporization.
Note 1: To use this practice, the user must have previously determined the POD for the non-cannabinoid ingredient under investigation and six uncertainty factors stated in this standard and correction factors.
1.3 This practice shall outline the steps for identifying the maximum allowable concentration limit of a non-cannabinoid ingredient that could be used in a proposed formulation from a POD or a defined TTC.
1.4 This practice shall outline the steps for comparing the concentration of a non-cannabinoid ingredient in an existing formulation to the calculated acceptable daily inhalation limit from a POD or a defined TTC of the non-cannabinoid ingredient under investigation.
1.5 This practice shall provide example scenarios to aid in the usage of the practice and understanding of how to perform the calculation.
1.6 This practice shall not define the means for calculating the acceptable daily inhalation limit from data generated in vitro.
1.7 This practice shall not define the means for calculating the acceptable daily inhalation limit from a lethal dose (for example, LC50 or LD50).
1.8 This practice shall not define the means for determining a POD or TTC for the non-cannabinoid ingredient under investigation.
1.8.1 A user must complete a toxicological risk based assessment to determine a POD or TTC for a non-cannabinoid ingredient under investigation. It is recommended to consult an experienced toxicologist when conducting the risk assessment.
1.9 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.
1.10 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.
