Regulatory DevelopmentsAugust 10, 2012
The U.S. Environmental Protection Agency (EPA) released a pre-publication version of a proposed amendment to the significant new use rule (SNUR) for perfluoroalkyl sulfonate (PFAS) chemical substances (available at 40 C.F.R. § 721.9582) to add seven PFAS chemical substances that have completed the new chemical review process under the Toxic Substances Control Act (TSCA), but have not yet commenced production or import, and to designate (for all listed PFAS chemical substances) processing as a significant new use. EPA is also proposing a SNUR for long-chain perfluoroalkyl carboxylate (LCPFAC) chemical substances that would designate manufacturing, importing, or processing for use as part of carpet or for treating carpet (e.g., for use in the carpet aftercare market) as a significant new use. The term LCPFAC refers to the long-chain category of perfluorinated carboxylate chemical substances with perfluorinated carbon chain lengths equal to or greater than seven carbons. The category of LCPFAC chemical substances also includes the salts and precursors of these perfluorinated carboxylates.
Significantly, EPA also is proposing that the article exemption set forth at 40 C.F.R. § 721.45(f) not apply to the import of LCPFAC chemical substances as part of carpet. Persons subject to the SNUR thus would not be exempt from significant new use reporting if they import LCPFAC chemical substances as part of carpet. One important distinction is that EPA is proposing to keep the article exemption in effect for persons who process chemical substances as part of an article because, with respect to carpet, existing stocks may still contain LCPFAC substances and thus such uses would be "existing" and could not be subject to a SNUR.
The proposed rule, to be issued under TSCA Section 5(a)(2) authority, would require persons to notify EPA at least 90 days before commencing any activity designated as a significant new use. The notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. Comments will be due no later than 60 days after the date of publication of the proposed SNUR in the Federal Register. EPA states that the docket will be available online under Docket ID EPA-HQ-OPPT-2012-0268. More information is available online.
According to EPA, the SNUR is consistent with EPA's December 30, 2009, "Long-Chain Perfluorinated Chemicals (PFCs) Action Plan." EPA provides the following rationale for the proposed amended SNUR for PFAS:
The PFAS chemical substances that EPA is proposing to add to the existing PFAS SNUR are the subjects of PMN Case Numbers P-83-0126, P-90-0110, P-94-1508, P-94-1509B, P-98-0809, P-99-0296, and P-01-0035. The PMN submitters for these chemicals never commenced manufacturing or import of these chemicals. EPA considers that the commencement of manufacturing, import, or processing of these chemicals would thus significantly increase the magnitude and duration of exposure to humans and the environment. Given the structural similarity of these chemicals to the PFAS chemicals covered under 40 CFR 721.9582 and EPA's health and environmental concerns associated with these chemicals, EPA has concluded any manufacturing, import, or processing for any use of these uncommenced PFAS chemicals would be a significant new use and therefore, action on these PFAS chemicals is warranted.
Regarding LCPFAC chemical substances, EPA states that it believes that these chemical substances are no longer being manufactured, processed, or imported for use as part of carpet or for treating carpet (e.g., for use in the carpet aftercare market) in the U.S. or being imported as part of carpet, but it remains concerned that LCPFAC chemicals may in the future be used again as part of carpet or for treating carpet or be redirected to other uses without prior notice to EPA. EPA notes:
While the Agency is currently only proposing as significant new uses of LCPFAC chemical substances use as part of carpet or to treat carpet, the Agency believes the 2010/2015 PFOA Stewardship Program will eliminate many other ongoing uses of LCPFAC chemical substances. As those uses are phased out in the United States, EPA anticipates taking additional regulatory actions to prevent resumption of the uses without prior notice to EPA.
The proposed decision to remove the article exemption (set forth at 40 C.F.R. § 721.45(f)) for the import of LCPFAC chemical substances as part of carpet is based on EPA's concern that "if in the future LCPFAC are incorporated in carpets and then imported, exposure would increase." EPA clarifies that the article exemption would remain in effect for persons who import LCPFAC chemical substances as part of other sorts of articles.
Persons who export or intend to export any of the substances identified in the proposed SNUR are subject to the export notification provisions of TSCA Section 12(b), even if the company does not manufacture, import, or process that substance in a manner restricted by the SNUR.
The proposal reflects EPA's increasing reliance on core TSCA provisions to address risks it believes are posed by chemical substances. EPA's increasingly routine practice of eliminating the exemption for articles in a SNUR was applied with more subtlety in the proposed LCPFAC SNUR insofar as the proposed revocation of the exemption is limited to imported carpet articles and, furthermore, EPA is not proposing to revoke the exemption for processing of articles, including for carpet articles. It will be interesting to see stakeholders' reaction to this more focused narrowing of the article exemption, especially in light of industry's requests for a more cogent "policy" on the use of SNURs and the elimination of the article exemption. Prior to recent proposed SNURs seeking to eliminate the article exemption, EPA had revoked the article exemption in a very limited number of cases. Also, in contrast to the approach in these recent SNURs, EPA provides a basis for its belief that import of LCPFAC-containing carpet is not ongoing -- in other recent SNUR proposals EPA has based its proposal to eliminate the article exemption on an assertion, unsupported in the rulemaking record, that article import was not ongoing. As we have noted before, applying the SNUR to imported articles represents a significant policy change that draws into the scope of any final rule a large number of businesses that are not generally subject to or familiar with SNUR requirements.
EPA has also continued its recent practice of including processing within the scope of the SNUR activities. In the current SNUR, EPA is proposing to expand the scope of the existing PFAS SNUR and the proposed LCPFAC SNUR to include processing of the affected chemicals (historically the scope of the PFAS SNUR was limited to manufacture and import, whereas for the LCPFAC chemicals "processing" as proposed is limited to carpet-related activities).
Another interesting aspect is the way that EPA has proposed to SNUR several PFAS new chemicals that completed Premanufacture Notification (PMN) review, but did not commence manufacture. While applying a SNUR is not unusual in the context of the 90-day PMN review, this seems to be the first time that EPA is proposing to SNUR uncommenced new chemicals as part of an otherwise existing chemicals-related action.
Finally, readers should note the language in Section V.A., Rationale, in the proposed SNUR. Here EPA seems to be generally asserting a very broad meaning to "significant new use" to mean any "new use." While this approach has been used in the past in cases where production had ceased (and thus any resumption of production might be seen as new and significant relative to zero production and use), EPA has tended to apply the approach more carefully in cases where production/import for uses other than those that are the subject of the proposed SNUR are ongoing. Our observation is offered specifically in reference to the LCPFAC chemicals; EPA seems to be asserting that the mere resumption of the use in carpet (despite the fact of extensive ongoing use in fluoropolymers as discussed in the proposal) is both significant and new without any discussion of why this is believed to be so. Given the need to show that the proposed significant new use is both "new" and "significant," seemingly some basis should be provided by EPA to explain how, when other uses are ongoing, this aspect of the rulemaking is satisfied.
Any entity having commercial interests in any of these substances should carefully review the SNUR and consider the need for comments. If any of the uses proposed to be added as significant new uses are in fact ongoing, that information would need to be provided to EPA. In those cases, EPA has asked that specific documentation of any such ongoing use be submitted.