In an announcement that portends substantial regulatory changes, the head of the U.S. Environmental Protection Agency (EPA) chemicals office announced a shift in policy to further regulate chemicals within manufactured goods or finished products. The change would mean that importers, manufacturers, and processors will need to know the chemicals in manufactured or finished goods and assess whether EPA restricts those chemicals.
Assistant Administrator Michal Freedhoff, who took over the Office of Chemical Safety and Pollution Prevention at EPA earlier this year, announced during remarks to the Product Stewardship Society on September 28, 2021, that EPA already viewed chemicals in manufactured or finished goods as subject to the Toxic Substances Control Act (TSCA). This is a shift of years of policy in which EPA carved out exemptions for manufactured goods or finished products, regulated as “articles” in TSCA regulations. Recognized exemptions for articles include those for import certification and Chemical Data Reporting (CDR). Freedhoff emphasized that EPA has always had this authority under TSCA and noted that European Union requirements already apply similarly to articles.
Recent regulatory actions by EPA on persistent, bioaccumulative, and toxic (PBT) chemicals and per- and polyfluoroalkyl substances (PFAS) show how the agency may impose this new view on regulating articles under TSCA.
- First, in January 2021, EPA issued regulations for five PBT chemicals, codified of 40 C.F.R. Part 751, Subpart E, which restricted the presence of some of those chemicals in products or articles, with some restrictions, beginning in 2021. For one of those chemicals, phenol, isopropylated phosphate (3:1), referred to as PIP (3:1), EPA extended the compliance deadline to March 2022 due to industry concerns about a perceived lack of notice weighed against the large compliance burden.
- Second, in June 2021, EPA issued a proposed rule that would require reporting from importers of articles containing PFAS. The rule would require manufacturers and importers of articles that contain one of the listed PFAS chemicals in any year since January 1, 2011, to report on PFAS uses, production volumes, disposals, and hazards.
Based on this announcement and recent developments, manufacturers and importers should pay attention to regulatory developments at EPA and comment on relevant proposals.