The Toxic Substances Control Act (TSCA) authorizes the United States Environmental Protection Agency (EPA) to impose restrictions relating to chemical substances and/or mixtures as well as requirements for reporting, record-keeping, and testing. One way that the EPA regulates chemical substances and mixtures is through premanufacture notices (PMN). Like its name indicates, a PMN is submitted to the EPA before manufacture or import of a new chemical substance for a nonexempt commercial purpose (i.e., materials not regulated by other federal programs, including pesticides, tobacco, firearms, nuclear materials, etc.). PMNs contain information such as chemical identity, process diagram and description, production volume, byproducts and impurities, intended use, etc.
TSCA and its regulations allow certain exemptions from PMN requirements. For example, low volume exemptions (LVEs) may be granted to chemical substances manufactured in quantities of 10,000 kilograms or less per year. In addition, low release and exposure exemptions (LoREXs) may be granted to chemical substances with specified (1) low exposure risks to consumers, the general population, and workers, as well as (2) low environmental release criteria to ambient surface water, ambient air from incineration, and land or groundwater.
On May 26, 2023, EPA proposed amendments to the new chemicals’ procedural regulations under TSCA that include amendments to the LVE and LoREX eligibility requirements. The proposed rule seeks to categorically disqualify perfluoroalkyl and polyfluoroalkyl substances (PFAS) from LVEs and LoREXs. Given their ineligibility, the EPA would consequently need to review PFAS through the full PMN process. The EPA proposes a structural definition for “PFAS” that is the same as the definition proposed in the recent EPA Inactive PFAS Significant New Use Rule. The proposed amendments would extend to chemical substances and mixtures “where any of the reasonably anticipated metabolites, environmental transformation products, byproducts, or reasonably anticipated impurities are a PFAS.”
The proposed regulatory amendments are consistent with recent EPA practice. In April 2021, EPA began implementing a new policy for reviewing and managing LVE notices for PFAS stating, “[g]iven the complexity of PFAS chemistry, potential health effects, and their longevity and persistence in the environment, an LVE notice for PFAS is unlikely to be eligible for this kind of exemption under the regulations.” Under the EPA PFAS LVE Stewardship Program, out of more than 600 previously granted PFAS LVEs, 45 were voluntarily withdrawn. EPA reports that it has not granted an LVE for PFAS since May 2020, and it has never received or approved any PFAS LoREX notices.
Under docket identification number EPA–HQ–OPPT–2022–0902, comments to the EPA’s proposed rule will be accepted through the Federal eRulemaking Portal until July 25, 2023.
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