EPA Announces Collaborative Research Program to Support New Chemical Reviews

(WASHINGTON, February 24, 2022) - Today, the U.S. Environmental Protection Agency (EPA) announced 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. The results of the effort are expected to bring innovative science to new chemical reviews, modernize the approaches used, and increase the transparency of the human health and ecological risk assessment process. 

“Science is the backbone of our chemical safety work, and strong science ensures we put measures in place to protect human health and the environment, when necessary,” said Assistant Administrator for the Office of Chemical Safety and Pollution Prevention Michal Freedhoff. “This exciting and collaborative effort announced today will modernize the processes and bring innovative science into the evaluation of new chemicals under TSCA, leading to a more sustainable program.”

“This collaborative effort between OCSPP and ORD will draw on ORD’s innovative science, expertise, and leadership in relevant areas such as high-throughput testing, computational toxicology and exposure approaches, and development of databases and tools to make data accessible and informative for chemical assessments. Work on this collaborative effort furthers ORD’s commitment to translating research into application and is complementary to efforts on EPA’s New Approach Methods Work Plan,” said Deputy Assistant Administrator for Science Policy in the Office of Research and Development Chris Frey.

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. 

Prior to the public meeting, EPA will release a draft document describing this collaborative research program for a 60-day public comment period. Following the public meeting, EPA intends to update the draft document as appropriate and will place the updated document in the docket. Later in 2022, the Agency plans to release a revised version of the collaborative research plan for an additional public comment period and peer review by the Board of Scientific Counselors (BOSC).

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.

Register for the public meeting.

Learn more about the Collaborative Research Program to Support New Chemical Reviews.