EPA TSCA Collaboration on New Chemicals

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On April 20-21, 2022, the United States 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 the opportunity to give their opinion. As noted in our March 14, 2022 memorandum on the draft document titled “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 year-long collaborative research program focused on approaches to conducting risk assessments of new chemicals under TSCA. Written comments on the draft document are due May 10, 2022.

Denise Keehner, Director of the Office of Pollution and Toxic Substances Prevention (OPPT), and Dr. Michal Ilana Freedhoff, Deputy Administrator of OCSPP, each delivered keynote addresses. According to Freedhoff, prior to the 2016 changes to the Frank R. Lautenberg Chemical Safety Act for the 21st Century (Lautenberg Act) at TSCA, the EPA only conducted a formal risk assessment for about 20% of new chemicals, while the remaining 80% were allowed to enter commerce without any restrictions. The Lautenberg Act requires the EPA to make a formal decision on the safety of all new chemicals, but the EPA has received no additional funding. Freedhoff said the New Chemicals Collaborative Research Program will strengthen the foundation of the New Chemicals Program.

Louis (Gino) Scarano, Ph.D., OCSPP, presented on current approaches and opportunities for the New Chemicals Collaborative Research Program. According to Scarano, the EPA receives about 500 new chemical submissions each year. Under TSCA, the EPA is generally required to review prefabrication notifications within 90 days. When the EPA affirmatively determines that a new chemical poses or may pose an unreasonable risk, the EPA must take steps to prevent those risks before the chemical can enter the market. When reviewing new chemicals, the EPA uses a hierarchy of data, first using chemical-specific test data, then analog data, then modeled data.

Katie Paul Friedman, Office of Research and Development (ORD), provided an overview of the five research areas proposed under the New Chemicals Collaborative Research Program: updating and refining chemical categories; develop and expand databases containing relevant TSCA chemical information; develop and refine quantitative structure-activity relationship (QSAR) models and predictive models for physico-chemical properties, environmental fate/transport, hazard, exposure and toxicokinetics; explore ways to integrate and apply New Approach Methodologies (NAM) in new chemical assessments; and developing a TSCA New Chemicals Decision Support Tool to modernize the process.

Warren Casey, National Institute of Environmental Health Sciences (NIEHS), National Toxicology Program Division (DNTP), presented on how the NIEHS/DNTP and the Center’s Division of Preclinical Innovation (DPI) National Institute for the Advancement of Translational Sciences (NCATS) support EPA’s efforts. According to Casey, NIEHS/DNTP hopes to formally and publicly announce its commitment to work with the EPA through a Memorandum of Understanding (MOU) which is expected to be released “in a month or two.” Mike Rasenberg, European Chemicals Agency (ECHA), discussed the International Uniform Chemical Information Database (IUCLID), a software application for recording, storing, maintaining and exchanging data on the intrinsic and hazardous properties of chemical substances. The European Union (EU) REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) regulations require ECHA to develop and maintain IUCLID, but ECHA does so in collaboration with the Organization for Development Cooperation Economics (OECD). Other countries using IUCLID are Australia, Canada, Japan, Switzerland and New Zealand.

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

  • Please indicate the extent to which this area of ​​research responds to the challenges of the New Chemicals Program; and
  • Are there additional elements in this area of ​​research that the EPA should consider?

EPA also asked an overarching question, whether there are other areas of research or information that EPA should consider adding to the collaborative research program.

Next steps

EPA will make the meeting slides and a summary of the meeting available. Later this year, the EPA plans to engage its Board of Science Advisors (BOSC), a federal advisory committee, for peer review. The EPA will issue a Federal Register notice announcing the BOSC meeting and opening a file for public comment. According to the draft document, the EPA will seek additional peer review and public comment at several points during the development and implementation phases of the research.

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