Understanding the US EPA TSCA Section 5 Review Process and Application of Predictive Models

The passage of the Frank R. Lautenberg Chemical Safety for the 21st Century Act on June 22 2016 had a profound impact on the US New Chemicals Program. This workshop will highlight important changes in the new chemical program and provide technical training on the risk assessment process. This educational course builds upon training material originally developed under the US EPA Sustainable Futures program.

During this hands-on 2.5-day workshop, you will learn about a variety of methods and models to conduct a preliminary risk assessment before submitting new chemical notifications to the US EPA to better anticipate regulatory concerns and identify critical outcomes. Speakers will highlight useful notification strategies and demonstrate tools to help identify risk-prone activities, support targeted testing strategies and potentially reduce the Agency review time by decreasing the need for back and forth communication during the notification period. The workshop includes in-depth presentations on hazard, exposure and risk screening to address ecological and human health concerns and provides hands-on sessions with US EPA and OECD computer-based models.

Over the 2.5 days, topics to be covered include US EPA and OECD approaches for:

  • Determining important physical-chemical properties of a substance along with methods to identify environmental attributes of concern;
  • Creating a screening-level hazard assessment for human health and primary environmental media with a focus on principles for analogue analysis and read across to fill data gaps; and
  • Modelling industrial operations including manufacturing, processing, commercial and consumer use activities, and the potential environmental release and human exposure from those activities.