On February 25, 2025, the U.S. Government Accountability Office (GAO) issued a report entitled High-Risk Series: Heightened Attention Could Save Billions More and Improve Government Efficiency and Effectiveness, “highlight[ing] 38 areas across the federal government that are seriously vulnerable to waste, fraud, abuse, and mismanagement or that are in need of transformation.” The category “Seizing Opportunities to Better Protect Public Health and Reduce Risk” lists high-risk areas focused on addressing critical weaknesses in public health efforts, including “ensuring the Environmental Protection Agency [(EPA)] provides more timely reviews of potentially toxic chemicals before they are introduced into commercial production and widespread public use.” GAO’s report includes an overview of “Transforming EPA’s Process for Assessing and Managing Chemical Risks,” noting that EPA “needs to address capacity issues to more effectively assess and manage chemicals posing risks to human health and the environment.” GAO added this issue to its High-Risk List in 2009 because EPA had not developed sufficient risk information to limit exposure to chemicals that may pose a risk to human health and because of issues with the Integrated Risk Information System’s (IRIS) Program. Since then, the Toxic Substances Control Act (TSCA) was amended in 2016 by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, prompting EPA to change its approach to assessing and managing chemicals. Similarly, the Office of Research and Development (ORD) “is more effectively using its portfolio of toxic chemical assessment products — which include IRIS and other chemical assessments like Provisional Peer-Reviewed Toxicity Values — to provide a range of risk assessments informing EPA’s decision-making on the protection of public health and the environment.” GAO states that given the changes to these programs, it is evaluating EPA’s work managing chemical risks through a single combined rating and will no longer assess the IRIS Program and TSCA implementation separately.
GAO’s rating is unchanged since the last update, finding that all five criteria still need attention:
- Leadership commitment (partially met): Since 2023, EPA leadership has continued to demonstrate a strong commitment to implementing its TSCA responsibilities, including seeking resources to address outstanding program needs. According to former President Biden’s fiscal year 2025 request, these additional resources are essential for EPA to complete existing chemical risk evaluations within the statutory timeframe and modernize information technology (IT) systems supporting the TSCA program. EPA leadership and officials in ORD overseeing the IRIS Program have not increased resources or examined workforce needs for either the program or across EPA, however.
- Capacity (partially met): The Office of Chemical Safety and Pollution Prevention (OCSPP) and IRIS Program officials reported a lack of capacity to carry out their work effectively, but both have taken steps to identify needed resources. According to EPA, among the 1,163 premanufacture notice (PMN) reviews completed between 2017 and 2022, EPA typically made its determination within the initial 90-day review period less than ten percent of the time. According to GAO, EPA specifically completed these reviews in 181 days or more between 53 and 90 percent of the time. GAO states that the OCSPP Assistant Administrator “stated that although EPA has prioritized resources for its new chemicals program, the agency will continue to struggle for as long as the budgetary constraints persist. Moreover, senior managers in OCSPP’s New Chemicals Division [(NCD)] told us the division lacks expertise and resources to assess the sufficiency of its existing evidence-building capacity or to identify actions to maintain or enhance that capacity.”
- Action plan (partially met): The IRIS Program and OCSPP’s NCD have conducted strategic planning activities. IRIS Program staff included in their April 2024 resource analysis the Program’s plans for preparing various types of chemical assessments relying on current budget and human resources. NCD drafted a strategic plan in August 2024 that includes five goals related to the New Chemicals Program and identifies metrics and strategies for achieving each goal. GAO notes that it found that NCD “did not follow key practices for effectively assessing, building, or using evidence for its planning activities,” however.
- Monitoring (partially met): The IRIS Program’s April 2024 resource analysis included metrics to track the Program’s progress in meeting user needs for chemical assessments. The IRIS Program improved its monitoring processes by implementing changes to the Program’s chemical nomination surveys in 2022 and to the way that survey was carried out. GAO states that it found that OCSPP’s NCD did not follow key practices for effectively assessing, building, or using evidence for its activities, however. It found NCD had not completed foundational planning actions, such as preparing its draft strategic plan in final.
- Demonstrated progress (partially met): The IRIS Program has made progress in carrying out its chemical assessment activities. EPA has made progress in implementing its PFAS Strategic Roadmap, as well. OCSPP continues to face challenges in carrying out its responsibility to make determinations on new chemical reviews within the 90-day review period, however. According to GAO, EPA stated that it is committed to improving the efficiency and transparency of its New Chemicals Program and has launched related process improvements, such as finalizing updates to the regulations that govern new chemical reviews.
GAO concludes that attention is needed to resources (budgetary and staffing), strategic planning, and monitoring to make progress in this high-risk area. According to GAO, as of January 2025, three recommendations related to assessing and managing chemical risks remain open, including the following focused on OCSPP’s planning and assessment efforts:
- OCSPP should develop a process and timeline to align fully its workforce planning efforts for implementing TSCA chemical review responsibilities with workforce planning principles;
- OCSPP’s NCD should, as it prepares its strategic plan in final, address relevant key practices for managing and assessing the New Chemicals Program, including involving stakeholders and identifying resources; and
- OCSPP’s NCD should implement a systematic process for aligning its performance management approach with key management and assessment practices.