TSCA New Chemicals Review for PFAS
The Toxic Substances Control Act (TSCA) requires manufacturers to notify EPA before introducing new chemicals to commerce. EPA reviews pre-manufacture notices (PMNs) and can require testing, restrict conditions of use, or prohibit manufacture. For PFAS — a class with well-established hazard concerns — EPA has strengthened its PMN review process to require affirmative finding of safety before PFAS are allowed into commerce.
The 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act reformed TSCA and strengthened EPA’s new chemicals review authority. Under the reformed TSCA, EPA must make affirmative findings about new chemicals’ safety; it can no longer allow chemicals to proceed to market simply by failing to act within the review period.
Significant New Use Rules for PFAS
When a PFAS compound is subject to a Significant New Use Rule (SNUR), any entity wanting to use it in a way not covered by the SNUR must provide advance notification to EPA. This gives EPA an opportunity to review new PFAS uses before they begin and potentially impose restrictions.
EPA has issued SNURs for specific PFAS compounds, including long-chain perfluoroalkyl carboxylic acids (PFCAs) and their precursors. SNURs are more targeted than full TSCA Section 6 rules but provide meaningful review authority for specific high-risk PFAS applications. The development of SNURs for additional PFAS is ongoing in EPA’s chemical management portfolio.
Limitations of the TSCA Framework for PFAS
TSCA’s chemical-by-chemical review framework is poorly matched to the PFAS challenge, where thousands of existing compounds are in commerce and new variants continue to be developed. The resource intensity of individual chemical review means EPA cannot keep pace with PFAS substitution patterns where restricted compounds are replaced by structurally similar alternatives.
TSCA Section 4 rulemaking authority — allowing EPA to require testing of chemicals with data gaps — is being used to require PFAS manufacturers to generate toxicological data for compounds with limited health effects information. These testing requirements build the evidence base needed for future regulatory actions and reduce information asymmetry between manufacturers (who have internal data) and regulators (who need independent data).