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Challenges of Inhalation Risk Assessment: Data, Models, and New Approaches Methods (NAMs) to Support Evidence Integration
Citation:
Pandalai, S. AND A. Jarabek. Challenges of Inhalation Risk Assessment: Data, Models, and New Approaches Methods (NAMs) to Support Evidence Integration. 2025 Toxicology and Risk Assessment Conference (TRAC 2025), Cincinnati, OH, May 12 - 15, 2025.
Impact/Purpose:
The purpose of the workshop is to review basis issues regarding toxicity data related to inhalation exposures, characteristics of data need for use in risk assessment, the role of dosimetry adjustments to provide translation and evidence integration, and consider how to evaluate emerging inhalation NAMs. The overall abstract will be accompanied by an individual abstract and presentation in this same workshop at a later date.
Description:
Inhalation exposures are a major class of hazards found in occupational, environmental, and military contexts. Examination of relevant inhalation toxicity data and evidence integration are fundamental to support risk assessment analyses and inform risk management efforts. This workshop will review basic issues regarding toxicity data related to inhalation exposures, characteristics of data needed for use in risk assessment, the role of dosimetry adjustments and models needed for exposure alignment, and dose-response analysis tools. Dosimetry models mentioned will include the EPA Multiple Path Particle Dosimetry (EPA MPPD v.2.0), computational fluid dynamics (CFD) and computational fluid particle dynamics (CFPD), and physiologically based pharmacokinetic (PBPK) models. How dose metrics are then used in dose-response analyses using the EPA’s benchmark dose modeling suite (BMDS) will be discussed. Topics related to challenges of characterization and how to include New Approach Method (NAM) data into evidence integration will be discussed. There will also be a discussion of the role of inhalational toxicologic data and risk assessment analyses for risk management and policy and guidance setting. Examples and exercises will be used to illustrate key points. The goal of the workshop is to provide attendees with an understanding of core methods and tools to develop risk assessments using inhalation toxicity information.
