Skip to main content
U.S. flag

An official website of the United States government

Here’s how you know

Dot gov

Official websites use .gov
A .gov website belongs to an official government organization in the United States.

HTTPS

Secure .gov websites use HTTPS
A lock ( Lock A locked padlock ) or https:// means you’ve safely connected to the .gov website. Share sensitive information only on official, secure websites.

  • Environmental Topics
  • Laws & Regulations
  • Report a Violation
  • About EPA
Risk Assessment
Contact Us

Application of Mechanistic Data in Risk Assessment: Exposure Alignment and Evidence Integration

On this page:

  • Overview
Risk assessment relies on integration of available and relevant evidence across several data streams by necessity.  While systematic review can identify relevant data, approaches for integration are still needed.  Conceptual constructs for source-to-outcome modeling based on the aggregate exposure pathway (AEP) and adverse outcome pathway (AOP) frameworks can provide a mechanistic scaffold for evidence integration to include application of novel approach methods (NAMs). Based on the conceptual construct, this presentation highlights the critical role of dosimetry models to provide exposure alignment across experimental platforms and illustrates impact with two recent integrated approaches to testing and assessment (IATA) under TSCA Section 5 for evaluation of new chemical substances.  Both IATA formalized a role for NAMs.  These IATA demonstrate how consideration of physicochemical properties and NAMs aimed at key events of AOPs create context for evaluation of the need and strategy for higher-tiered testing based on mechanistic responses, dosimetry, and exposure information. 

Impact/Purpose

Invited presentation in a session hosted by NICEATM and CORESTA (Centre de Coopération pour les Recherches Scientifiques Relatives au Tabac/Cooperation Centre for Scientific Research Relative to Tobacco) .  Participants include FDA, NICEATM, PSCI and PNNL in addition to EPA.  Impact will be technology transfer of current work wiht OCSPP on in vitro to in vivo extrapolation (IVIVE) and integrated approaches to testing and assessment (IATA) for inhalation exposures. 

Citation

Jarabek, A. Application of Mechanistic Data in Risk Assessment: Exposure Alignment and Evidence Integration. Advancing New Alternative Methods for Tobacco Harm Reduction, Durham, NC, October 18 - 22, 2021.
  • Risk Assessment Home
  • About Risk Assessment
  • Risk Recent Additions
  • Human Health Risk Assessment
  • Ecological Risk Assessment
  • Risk Advanced Search
    • Risk Publications
  • Risk Assessment Guidance
  • Risk Tools and Databases
  • Superfund Risk Assessment
  • Where you live
Contact Us to ask a question, provide feedback, or report a problem.
Last updated on October 06, 2021
United States Environmental Protection Agency

Discover.

  • Accessibility Statement
  • Budget & Performance
  • Contracting
  • EPA www Web Snapshots
  • Grants
  • No FEAR Act Data
  • Privacy
  • Privacy and Security Notice

Connect.

  • Data
  • Inspector General
  • Jobs
  • Newsroom
  • Open Government
  • Regulations.gov
  • Subscribe
  • USA.gov
  • White House

Ask.

  • Contact EPA
  • EPA Disclaimers
  • Hotlines
  • FOIA Requests
  • Frequent Questions

Follow.