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GAO Recommends EPA’s New Chemicals Program Develop a Systematic Process to Manage and Assess Performance Better
Thursday, January 23, 2025

The U.S. Government Accountability Office (GAO) publicly released a report entitled “New Chemicals Program: EPA Needs a Systematic Process to Better Manage and Assess Performance” on January 22, 2025. GAO states that it was asked to review the U.S. Environmental Protection Agency’s (EPA) implementation of its Toxic Substances Control Act (TSCA) New Chemicals Program. The report summarizes the perspectives of selected manufacturers on EPA’s review process and evaluates the extent to which EPA follows key practices for managing and assessing the program. GAO identified a random, nongeneralizable sample of premanufacture notices (PMN) submitted to EPA from October 2021 to April 2024 and interviewed 19 manufacturers that submitted these notices. GAO also compared EPA’s management and assessment activities to key practices it developed based on federal laws, federal guidance, and prior GAO work.

According to GAO, the manufacturer representatives identified a range of challenges, strengths, and potential improvements for EPA’s new chemicals review process. For example, most (16 of 19) representatives told GAO they experienced review delays and described effects of these delays on their businesses. GAO states that the effects manufacturers cited included harming customer relations, creating a competitive advantage for existing chemical alternatives at the expense of new chemicals, and hindering market participation.

GAO notes that the representatives also identified strengths in how EPA implements the program and potential process improvements. For example, almost all (18 of 19) of the representatives found EPA’s public information sources somewhat or very helpful. Representatives suggested that EPA improve the new chemicals review process by clarifying review requirements, providing realistic timeframes for completing reviews, and improving communication, among other improvements.

According to GAO, EPA’s New Chemicals Division (NCD) has taken important initial planning steps but has not followed most key practices for managing and assessing the results of its New Chemicals Program. For example, in August 2024, NCD drafted a strategic plan that identifies five strategic goals and how to achieve them. GAO states that NCD did not follow some relevant key practices in developing the plan, however, including involving external stakeholders and identifying resources needed to achieve each draft goal. Moreover, NCD officials told GAO that they had not developed a systematic process to ensure that NCD consistently follows all key practices.

GAO recommends that:

  • The EPA Administrator should ensure that NCD, as it prepares its final strategic plan, addresses relevant key practices for managing and assessing the New Chemicals Program, including involving stakeholders and identifying resources; and
  • The EPA Administrator should ensure NCD implements a systematic process that aligns its performance management approach with key management and assessment practices.

EPA agreed with GAO’s recommendations.

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