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In 2015, EPA proposed amending the significant new use rules (SNURs) under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for long-chain perfluoroalkyl carboxylate (LCPFAC) chemical substances, and for perfluorooctanoic acid (PFOA) or its salts. Specifically, EPA proposed to amend the SNUR for LCPFAC chemical substances by designating as a significant new use manufacturing (including importing) or processing of an identified subset of LCPFAC chemical substances for any use that will not be ongoing after December 31, 2015, and all other LCPFAC chemicals substances for which there are currently no ongoing uses. EPA also proposed to make inapplicable the exemption for persons who import LCPFAC chemical substances as part of articles. In addition, EPA proposed to amend a SNUR for perfluoroalkyl sulfonate (PFAS) chemical substances that would make inapplicable the exemption for persons who import PFAS chemical substances as part of carpets. Persons subject to these SNURs would be required to notify the EPA at least 90 days before commencing such manufacture or processing. The required notifications would initiate EPA's evaluation of the intended use within the applicable review period. Manufacture and processing for the significant new use would be unable to commence until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required in association with that determination. EPA is developing a supplemental proposal for the LCPFAC SNUR amendments to make inapplicable the exemption for persons who import a subset of LCPFAC chemical substances as part of certain articles. This supplemental proposal is intended to be responsive to the article consideration provision in TSCA section 5(a)(5), that was added with the 2016 amendments to TSCA and which states that articles can be subject to notification requirements as a significant new use provided that EPA makes an affirmative finding in a rule that there is reasonable potential for exposure to a chemical from an article or category of articles.

Statement of Need:

This action is identified in the PFAS Action Plan that the EPA Administrator announced on February 14, 2019. As described in more detail in the proposed rule, EPA has determined that these SNURs are necessary to ensure that EPA receives timely advance notice of any future manufacturing (including importing) and processing of these LCPFAC chemical substances for new uses that may produce changes in human and environmental exposures. The rationale and objectives for these SNURs are explained in more detail in the proposed rule.

Summary of the Legal Basis:

This action is being developed under the authority of section 5(a) of the Toxic Substances Control Act (TSCA) (15 U.S.C. 2604(a)(2)) which authorizes EPA to determine that a use of a chemical substance is a significant new use. EPA must make this determination by rule after considering all relevant factors, including those listed in TSCA section 5(a)(2). Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1)(B) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture or process the chemical substance for that use (15 U.S.C. 2604(a)(1)(B)).

Alternatives:

As discussed in more detail in the 2015 proposed rule, EPA considered the following alternative regulatory actions before proposing the SNUR.

Under a TSCA section 8(a) rule, EPA could, among other things, generally require persons to report information to the Agency when they intend to manufacture or process a listed chemical for a specific use or any use. However, in view of the level of health and environmental concerns about LCPFAC and PFAS chemical substances if used for the proposed significant new use, EPA believes that a TSCA section 8(a) rule for this chemical substance would not meet EPA’s regulatory objectives.

Under TCSA section 6, EPA may regulate a chemical substance if the Administrator finds that there is a reasonable basis to conclude that the manufacture, processing, distribution in commerce, use or disposal of a chemical substance or mixture . . . presents or will present an unreasonable risk of injury to health or the environment. (TSCA section 6(a)). Given that these chemical substances are believed to be phasing out, EPA concluded that risk management action under TSCA section 6 was not necessary at that time.

Anticipated Costs and Benefits:

EPA has evaluated the potential impacts of establishing SNUR reporting requirements for potential manufacturers (including importers) and processors of the LCPAC chemical substances included in this proposed rule. The economic analysis, which is available in the docket, is briefly summarized here.

In the event that a SNUN is submitted, costs are estimated to be less than $8,589 per SNUN submission for large business submitters and $6,189 for small business submitters. These estimates include the cost to prepare and submit the SNUN and the payment of a user fee. In addition, for persons exporting a chemical substance that is the subject of a SNUR, a one-time notice must be provided for the first export or intended export to a particular country, which is estimated to cost less than $100 on average per notification. The proposed rule may also affect firms that plan to import articles that contain LCFPAC chemical substances, because, while not required by the SNUR, these parties may take additional steps to determine whether LCPFAC chemical substances are part of the articles that they are considering to import. In the accompanying Economic Analysis for this proposed SNUR, example steps (and their respective costs) that an importer might take to identify LCPFAC chemicals in articles are provided. These can include gathering information through agreements with suppliers, declarations through databases or surveys, or use of a third-party certification system. Additionally, importers may require suppliers to provide certificates of testing analysis of the products or perform their own laboratory testing of certain articles. EPA is unable to predict, however, what, if any, particular steps an importer might take; potential total costs were not.

Risks:

The chemical uses covered by these SNURs are not ongoing, i.e., they are either new or have been phased out. The reporting requirement imposed by the SNUR is intended to ensure that EPA receives timely advance notice of any future manufacturing (including importing) and processing of these LCPFAC chemical substances for new uses that may produce changes in human and environmental exposures. The required notifications would initiate EPA's evaluation of the intended use within the applicable review period. Manufacture and processing for the significant new use would be unable to commence until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required in association with that determination .