Regulatory Developments

TSCA: EPA Proposes a Significant New Use Rule That Would Close a Chapter on Perfluorinated Chemicals

January 23, 2015

On January 21, 2015, the U.S. Environmental Protection Agency (EPA) issued a proposed amendment to a significant new use rule (SNUR) for long-chain perfluoroalkyl carboxylate (LCPFAC) chemicals. According to EPA's January 15, 2015, press release, EPA intends the proposed amendment "to ensure that perfluorinated chemicals that have been phased out do not re-enter the marketplace without review." The proposed amendment would require anyone who intends to import these perfluorinated chemicals, including in articles, or domestically produce or process these chemicals for any new use to submit a notification to EPA at least 90 days before beginning the activity. Comments on the proposed amendment are due March 23, 2015.

Background

In the late 1990s-early 2000s, EPA identified significant potential issues presented by PFOS (perfluorooctyl sulfonic acid), a perfluorinated acid. Data showed PFOS to be present in low levels in humans and wildlife worldwide, and that PFOS appeared to be highly persistent. At the time, PFOS was used in a myriad of industrial and consumer applications, including soil and stain repellant sprays, fire-fighting foams, semiconductor manufacture, and other uses. 3M Company, the principal domestic manufacturer of PFOS, decided to phase it out of production between 2000 and 2002. EPA, working with industry, followed this voluntary action with a series of SNURs that were effectively intended to limit uses to those for which alternatives were not available. Several years later, similar concerns were raised with regard to PFOA (perfluorooctanoic acid), other LCPFACs, as well as for other chemicals known as fluorinated telomers that potentially could degrade to PFOA in the environment. As with PFOS, EPA worked with the manufacturers and users of these chemicals to understand the risks better and to encourage the development of alternatives. These efforts yielded the 2010/2015 PFOA Stewardship Program through which industry made and delivered on a series of commitments that, over time, made the current proposed SNUR possible.

EPA announced the 2010/2015 PFOA Stewardship Program in 2006. Under the Program, eight companies committed voluntarily to reduce facility emissions and product content of PFOA and related chemicals on a global basis by 95 percent no later than 2010, and to work toward eliminating emissions and product content of these chemicals by 2015. According to EPA's fact sheet on LCPFAC chemicals, the companies "continue to reduce emissions as well as overall product content of long-chain perfluorinated chemicals and have informed EPA that they are on track to phase out LCPFACs by the end of 2015." EPA states in its press release that it issued the proposed SNUR "in part in anticipation of this 2015 phase-out deadline." In 2013, EPA promulgated a SNUR for use of perfluorinated chemicals in carpets and carpet aftercare products. More information regarding this SNUR is available in Bergeson & Campbell, P.C.'s October 2, 2013, memorandum, "EPA Announces Final Rule Concerning Perfluoroalkyl Sulfonates and Long-Chain Perfluoroalkyl Carboxylate Chemical Substances."

Proposed SNUR for LCPFAC Chemicals

EPA proposes amending the SNUR for LCPFAC chemicals by designating as a significant new use manufacturing, including importing, or processing of certain LCPFAC chemical substances for any use that will not be ongoing after December 31, 2015, and all other LCPFAC chemical substances for which there are currently no ongoing uses. EPA also proposes to make inapplicable the exemption for persons who import LCPFAC chemicals as part of articles, as well as to amend a SNUR for perfluoroalkyl sulfonate (PFAS) chemical substances that would make the article exemption inapplicable for import of PFAS chemicals as part of carpets (although EPA makes clear that the proposed SNUR would not apply to processing of these chemicals as part of an article). Persons subject to these SNURs would be required to notify EPA at least 90 days before commencing such manufacture or processing. The required notifications would provide EPA with the opportunity to evaluate the intended use and, if necessary, to protect against potential unreasonable risks from that activity before it occurs.

EPA states that it welcomes comments on any aspect of the proposed amended SNUR. EPA particularly requests comment on whether any of the current uses of any of the specific LCPFAC chemicals identified in the notice will continue to be ongoing after December 31, 2015, or whether there are any ongoing uses of PFOA and its salts identified in the notice. EPA also requests comment on whether there are currently any ongoing uses, including use as part of articles, of any of the remaining LCPFAC chemical substances that were not identified in the 2012 Chemical Data Reporting Rule. EPA requests specific documentation of any such ongoing use.

EPA also makes clear in the proposed SNUR that it does not apply to certain perfluorinated chemicals, including fluoropolymers, LCPFACs with more than 20 perfluorinated carbons, and "import of fluoropolymer dispersions and emulsions, as well as fluoropolymers as part of articles, containing PFOA or its salts." EPA states: "However, import of fluoropolymer dispersions and emulsions, and fluoropolymers as part of articles, containing PFOA or its salts was not determined to be a significant new use because this use is currently ongoing and EPA is not making inapplicable any of the standard exemptions at 40 CFR 721.45 for PFOA."

Commentary

The proposed rule is significant in the way that it signals the closing chapter of a 15-year collaborative effort between EPA and industry to recognize the issues presented by PFOS, PFOA, and other LCPFACs, and to develop over 150 alternatives that would allow for production of the LCPFACs to be largely phased-out, and with only a limited number of remaining uses where alternatives are yet to be developed. The significance of this effort can be seen in the results of the human biomonitoring done by the Centers for Disease Control and Prevention, which, as reported in EPA's press statement, shows a "41 percent reduction in human blood-levels" over time. A graphic from EPA's report on America's Children and the Environment (www.epa.gov/ace) shows the reduction which has occurred since 1999.

Another point to note is that EPA, in proposing to make the article exemption inapplicable to LCPFACs, included data indicating that perfluorinated chemicals can be released from articles of commerce, thus offering a justification for its decision to remove the exemption for imported articles in the proposed SNUR. EPA's efforts to explain and offer data in support of its decision to remove the article exemption may be a harbinger of future data-based explanations in connection with other SNURs that would affect the article exemption.


 
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