1. Scope

This standard 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: To use this standard, the user must have previously determined the POD for the non-cannabinoid ingredient under investigation and all relevant uncertainty factors and correction factors.

This standard 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.

This standard 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.

This standard shall provide example scenarios to aid in the usage of the practice and understanding of how to perform the calculation.

This standard shall not define the means for calculating the acceptable daily inhalation limit from data generated in vitro.

This standard shall not define the means for calculating the acceptable daily inhalation limit from a lethal dose (e.g. LC50 or LD50).

This standard shall not define the means for determining a POD or TTC for the non-cannabinoid ingredient under investigation.

Discussion: 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.

Keywords

Cannabis; hemp; marijuana; THC; CBD; d9-THC; CBDA; THCA; toxicology; industrial hemp; safety; limit; concentration; industrial hemp; toxicity; intoxicating; non-intoxicating; additive; component; formulation; delta-8;

Rationale

The following practice for calculating the acceptable daily inhalation limit for a non-cannabinoid ingredient intended for use in a cannabinoid product for vaporization was developed in collaboration with a diverse group of stakeholders representing device manufacturers, terpene blend producers, cannabinoid product manufacturers, consumers, scientists, toxicologists, and others.

The intent of this standard is to, among other things:
Provide an easy to understand equation for calculating the acceptable daily inhalation limit of a non-cannabinoid ingredient under investigation.
Breakdown the variables necessary to perform the calculations and their purpose.
Improve consumer health risks based on information available today.

While most of the input for this standard did come from North America, an effort was made to solicit as much feedback from impacted global marketplaces as possible. This standard is only the beginning and attempts to address a major gap regarding the safety of non-cannabinoid ingredients used in cannabinoid products intended for vaporization.

Please remember that ASTM International standards are living documents and are intended to be updated and revised over time. This initial version will not be perfect, but it will serve to provide marketplaces with the information they need to make informed decisions regarding requirements and regulations for non-cannabinoid ingredients used in cannabinoid products intended for vaporization.

The title and scope are in draft form and are under development within this ASTM Committee.