The US Environmental Protection Agency (EPA) took another step on June 22 in advancing its Per- and Polyfluoroalkyl Substances (PFAS) Action Plan by finalizing a Significant New Use Rule (SNUR) for long-chain perfluoroalkyl carboxylate (LCPFAC) and perfluoroalkyl sulfonate chemical substances (Final PFAS SNUR or Rule), while dropping certain “safe harbor” provisions.
Under the Final PFAS SNUR, issued under the Toxic Substances Control Act (TSCA), as amended by the 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act, EPA will be prohibiting parties from manufacturing, processing, or importing products containing certain long-chain PFAS without prior EPA review and approval. Pending EPA’s review, the agency may place restrictions on affected products in order to protect human health and the environment.
Under the Final PFAS SNUR, EPA designated as a significant new use manufacturing (including importing), processing, or distributing in commerce of (1) a subset of LCPFAC chemical substances for any use that was not ongoing after December 31, 2015; and (2) all other LCPFAC chemical substances for which there are no ongoing uses as of January 21, 2015. The new Rule also prohibits the import of products containing certain long-chain PFAS as a surface coating and carpet containing perfluoroalkyl sulfonate chemical substances without EPA review.
The Final PFAS SNUR reaches across a number of industries, including:
The Final PFAS SNUR, promulgated under TSCA Section 5(a)(5), requires parties to notify EPA at least 90 days before commencing the manufacture, import, or processing of the covered chemical substances. A party’s significant new use notification initiates EPA’s evaluation of the conditions of use, including the relevant TSCA 5(a)(2) factors (e.g., projected volume, extent of use of changes to the type or form of exposure to humans or the environment, increase of the magnitude and duration of exposure to humans or the environment, reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of the chemical substance). Manufacturing, importing, or processing for the significant new use are prohibited from commencing until EPA has completed its evaluation. Ongoing uses are not subject to the Rule (as SNURs only govern new uses), although they may be subject to other provisions of TSCA, such as the import and export rules under TSCA Sections 13 and 12(b), respectively.
EPA’s Final PFAS SNUR also dropped safe harbor provisions from earlier drafts of the proposed rule. In response to growing criticism and public comment, EPA removed a “de minimis” exemption below which notification would not be required and a “safe harbor” provision that allowed importers to avoid enforcement action if they could demonstrate that their use was ongoing prior to the effective date of the rule. Despite EPA’s decision to excise these provisions and not set a de minimis threshold for determining “reasonable potential for exposure,” EPA signaled that it will continue to engage with interested stakeholders on these issues.
The Final Rule will become effective 60 days after its publication in the Federal Register.
The Final PFAS SNUR provides EPA with the authority to review an expansive list of products containing PFAS prior to the products being manufactured, sold, or imported in the United States, and it will be imperative that stakeholders continue to evaluate their supply chains and manufacturing methods. Additionally, stakeholders should continue to engage EPA on its evaluation of potential safe harbor provisions. While the Final PFAS SNUR was originally aimed at addressing many chemicals no longer in use, EPA’s latest step in addressing PFAS under TSCA Section 5(a)(5) for significant new uses, rather than a more categorical approach under Section 6(a) (which would capture existing uses), and its decision to remove safe harbor provisions, may likely set a precedent for how EPA will address other PFAS under TSCA.
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