EPA seeks comment on draft document “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA”

In February 2022, EPA launched a new effort under the Toxic Substances Control Act (TSCA) to modernize the process and bring innovative science to the review of new chemicals before they can enter the marketplace.

Through this effort, the Office of Chemical Safety and Pollution Prevention (OCSPP) is proposing to develop and implement a multi-year collaborative research program in partnership with the Agency’s Office of Research and Development (ORD) and other federal entities focused on approaches for performing risk assessments on new chemical substances under TSCA.

EPA is holding a virtual public meeting on April 20 and 21, 2022, from 1:00 PM to approximately 5:00 PM (EDT) to provide an overview of the TSCA New Chemicals Collaborative Research Program and give individual stakeholders an opportunity to provide input. Written comments on the draft document are due April 26, 2022.

This multi-year research program will refine existing approaches and develop and implement new approach methodologies (NAMs) to ensure the best available science is used in TSCA new chemical evaluations. Key areas proposed in the TSCA New Chemicals Collaborative Research Program include:

  • Updating OCSPP’s approach using data from structurally-similar chemicals to determine potential risks from new chemicals, also known as read-across. This will increase the efficiency of new chemical reviews promoting the use of the best available data to protect human health and the environment.
  • Digitizing and consolidating information on chemicals to include data and studies that currently only exist in hard copy or in disparate TSCA databases. The information will be combined with publicly available sources to expand the amount of information available, enhancing chemical reviews and enabling efficient sharing of chemical information across EPA. Safeguards for confidential business information will be maintained as appropriate in this process.
  • Updating and augmenting the models used for predicting a chemical’s physical-chemical properties and environmental fate/transport, hazard, exposure, and toxicokinetics to provide a suite of models to be used for new chemicals assessments. The goal of this effort is to update the models to reflect the best available science, increase transparency, and establish a process for updating these models as science evolves.
  • Exploring ways to integrate and apply NAMs in new chemicals assessments, reducing the use of animal testing. As this effort evolves, the goal is to develop a suite of accepted, fit-for-purpose NAMs that could be used by external stakeholders for data submissions under TSCA as well as informing and expanding new chemical categories.
  • Developing a decision support tool that integrates the various information streams specifically used for new chemical risk assessments. The decision support tool will more efficiently integrate all the data streams (e.g., chemistry, fate, exposures, hazards) into a final risk assessment and transparently document the decisions and assumptions made. Simply put, this will facilitate the new chemicals program tracking decisions over time and evaluating consistency within and across chemistries.

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