Regulatory Developments

EPA Holds Meeting on TSCA New Chemicals Collaborative Research Program

April 22, 2022 PRINT

On April 20-21, 2022, the U.S. Environmental Protection Agency (EPA) held a virtual public meeting to provide an overview of the Toxic Substances Control Act (TSCA) New Chemicals Collaborative Research Program and give stakeholders an opportunity to provide input. As reported in our March 14, 2022, memorandum on the draft document entitled “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA,” the Office of Chemical Safety and Pollution Prevention (OCSPP) proposes to develop and implement a multi-year collaborative research program focused on approaches for performing risk assessments on new chemical substances under TSCA. Written comments on the draft document are due May 10, 2022.

Denise Keehner, Director of the Office of Pollution Prevention and Toxics (OPPT), and Dr. Michal Ilana Freedhoff, Assistant Administrator for OCSPP, each provided opening remarks. According to Freedhoff, prior to the 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) amendments to TSCA, EPA did a formal risk assessment for only about 20 percent of new chemicals, while the other 80 percent were allowed to enter into commerce without any restrictions. The Lautenberg Act requires EPA to make a formal determination on the safety of all new chemicals, but EPA has not received any additional funding. Freedhoff stated that the New Chemicals Collaborative Research Program will strengthen the foundation of the New Chemicals Program.

Louis (Gino) Scarano, Ph.D., OCSPP, gave a presentation on the current approaches and opportunities for the New Chemicals Collaborative Research Program. According to Scarano, EPA receives about 500 new chemical submissions annually. Under TSCA, EPA is generally required to review premanufacture notifications within 90 days. Where EPA makes an affirmative determination that a new chemical presents or may present an unreasonable risk, EPA must take action to prevent those risks before the chemical can enter commerce. In reviewing new chemicals, EPA uses a data hierarchy, using chemical-specific test data first, then analog data, then modeled data.

Katie Paul Friedman, Office of Research and Development (ORD), provided an overview of the five proposed areas of research under the New Chemicals Collaborative Research Program: update and refine chemical categories; develop and expand databases that contain information relevant to TSCA chemicals; develop and refine Quantitative Structure-Activity Relationship (QSAR) models and predictive models for physical-chemical properties, environmental fate/transport, hazard, exposure, and toxicokinetics; explore ways to integrate and apply new approach methodologies (NAM) in new chemical assessments; and develop a TSCA new chemicals decision support tool to modernize the process.

Warren Casey, National Institute of Environmental Health Sciences (NIEHS), Division of the National Toxicology Program (DNTP), gave a presentation on how NIEHS/DNTP and the National Center for Advancing Translational Sciences’ (NCATS) Division of Preclinical Innovation (DPI) are supporting EPA’s efforts. According to Casey, NIEHS/DNTP hopes to announce formally and publicly its commitment to working with EPA through a memorandum of understanding (MOU) that should be out “in the next month or two.” Mike Rasenberg, European Chemicals Agency (ECHA), spoke about the International Uniform Chemical Information Database (IUCLID), a software application to record, store, maintain, and exchange data on intrinsic and hazard properties of chemical substances. The European Union’s (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation requires ECHA to develop and maintain IUCLID, but ECHA does so in collaboration with the Organization for Economic Cooperation and Development (OECD). Other countries using IUCLID include Australia, Canada, Japan, Switzerland, and New Zealand.

The workshop included breakout sessions on both days. In the breakout sessions, attendees were asked two questions for each of the five research areas:

  • Please comment on the extent to which this research area addresses the challenges of the New Chemicals Program; and
     
  • Are there additional components within this research area that EPA should consider?
     

EPA also asked one overarching question, whether there are other research areas or information that EPA should consider adding to the Collaborative Research Program.

Next Steps

EPA will make available the meeting slides and a summary of the meeting. Later this year, EPA plans to engage its Board of Scientific Counselors (BOSC), a federal advisory committee, for peer review. EPA will issue a Federal Register notice announcing the BOSC meeting and opening a docket for public comments. According to the draft document, EPA will solicit additional peer review and public comment at multiple points in the development and implementation phases of the research.


 
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