Last month, 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.

Per the EPA Feb. 24 announcement, the agency’s 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.

“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 EPA Deputy Assistant Administrator for Science Policy in the Office of Research and Development Chris Frey.

Draft Document & Public Meeting

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. Registration for the public meeting is available here.

On March 10, in advance of the public meeting, EPA made available a draft document, Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA. The draft document  outlines a joint project with ORD  to consolidate data and improve overall data quality used in PMN review. EPA is accepting comments through April 26, 2022 in the online docket at EPA-HQ-OPPT-2022-0218.

As a starting point, EPA and ORD will refine read across and data aggregation methods for the existing 56 chemical groupings identified in the 2010 New Chemical Category document. EPA has also set a goal of consolidating available data in a database so it can use data to refine QSAR (Quantitative Structure- Activity Relationship) modeling methods. This would include information about legacy chemicals, previously submitted confidential business information (CBI) and publicly available data. EPA will also standardize data to store in IUCLID1, with the intent of making any non-CBI data publicly available. EPA will identify and extract CBI including data on hazard, fate, and exposure.

EPA’s program implementation may be affected by ongoing litigation in EDF v. Regan (Case No. 1:20-cv-00762-EGS, Dist. Ct. of DC), alleging EPA has not implemented transparency requirements under the Lautenberg Act, during new chemical review. NGOs seek disclosure of preliminary chemical findings, companies’ safety data and increased public involvement during the PMN review process. The parties, having failed to reach an agreement over the prior two years of discussions, will actively litigate the case starting this year.

ACA is currently evaluating EPA’s draft document to consider commenting on CBI protections and overall efficacy.

Following the public meeting, EPA intends to update the draft document as appropriate and will place the updated document in the docket. EPA 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) later in 2022.

Details from EPA’s Announcement

Per EPA’s initial announcement, 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.

ACA will participate in the EPA’s public meetings on April 20 and 21 and coordinate any comments through its Product Stewardship Committee.

Contact ACA’s Riaz Zaman for more information.

[1] Additional information about IUCLID is available online at the website of the European Chemicals Agency at: https://echa.europa.eu/support/registration/creating-your-registration-dossier/what-is-iuclid-