The Frank R. Lautenberg Chemical Safety for the 21st Century Act, signed into law in June 2016, fundamentally revised the Toxic Substances Control Act (TSCA) for the first time since 1976. The Lautenberg Act overhauled how EPA evaluates and manages risks from existing chemicals in commerce, establishing mandatory deadlines, minimum risk evaluation standards, and a fee-based funding mechanism. For PFAS, the Act’s provisions have shaped both the pace and the scope of federal risk management—though significant delays and legal challenges have complicated implementation.
TSCA Risk Evaluation Process and PFAS Prioritization
Under the Lautenberg Act, EPA must designate chemicals as high or low priority for risk evaluation, then complete risk evaluations for high-priority substances within three to three-and-a-half years. Risk evaluations must assess risks to workers, consumers, and the general population across all conditions of use, without considering costs. If a risk evaluation finds unreasonable risk, EPA must then issue a risk management rule—typically within two years—that eliminates that unreasonable risk.
PFOA and PFOS were among the first ten chemicals designated for risk evaluation under the new process. However, the initial evaluations completed in 2020 under the Trump administration were widely criticized for scoping decisions that excluded legacy uses and contaminated sites from the conditions-of-use analysis—significantly narrowing the risk findings. EPA under the Biden administration issued revised scope documents and has committed to completing comprehensive risk evaluations that include all reasonably foreseen uses, including releases to the environment from historical production and use.
PFAS-Specific Provisions and Reporting Requirements
Beyond the standard risk evaluation process, the Lautenberg Act included PFAS-specific amendments added through subsequent legislation. The FY2020 NDAA required EPA to conduct a TSCA Section 8(a) rule requiring manufacturers and importers of PFAS to report production volumes, use information, disposal methods, and available health and environmental data. This reporting rule, finalized in 2024, covers approximately 1,400 PFAS compounds and will generate the most comprehensive dataset of U.S. PFAS production and use ever assembled.
The Lautenberg Act also strengthened TSCA Section 8(e) “substantial risk” reporting, requiring companies to notify EPA within 30 days when they obtain information reasonably supporting the conclusion that a chemical presents a substantial risk of injury to health or the environment. EPA has used this provision to compel submission of PFAS health studies previously held by manufacturers, contributing to a growing public database of industry-sponsored research.
Legal challenges to EPA’s risk evaluation scoping decisions and risk management proposals have extended PFAS regulatory timelines considerably. Industry petitions challenging the comprehensiveness of conditions-of-use analysis and the adequacy of EPA’s economic analysis have been filed in federal courts, introducing uncertainty about final rule implementation dates. Nevertheless, the Lautenberg Act’s mandatory deadline framework has maintained steady regulatory momentum compared to the prior TSCA regime, under which EPA completed only four risk assessments in 40 years.