The U.S. Environmental Protection Agency (EPA) released on February 20, 2020, a proposed supplemental significant new use rule (SNUR) for long-chain perfluoroalkyl carboxylate (LCPFAC) chemical substances that would make inapplicable the exemption for persons who import a subset of LCPFAC chemical substances as part of surface coatings on articles. Under the proposed supplemental SNUR, issued under Section 5(a)(2) of the Toxic Substances Control Act (TSCA), this subset of LCPFAC chemical substances also includes the salts and precursors of these perfluorinated carboxylates. The supplemental proposal would require importers to notify EPA at least 90 days before commencing the import of these chemical substances in certain articles for the significant new use described in the proposed SNUR. The required significant new use notification would initiate EPA’s evaluation of the conditions of use associated with the intended significant new use. Manufacturing (including import) or processing for the significant new use would be prohibited from commencing 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 posted a pre-publication version of the proposed supplemental SNUR on its website. Once EPA publishes the proposed supplemental SNUR in the Federal Register, a 45-day comment period will begin.

In a January 21, 2015, proposed SNUR for LCPFAC and perfluoroalkyl sulfonate (PFAS) chemical substances, EPA proposed to require notification of significant new uses from persons who import a subset of LCPFAC chemical substances as part of any article. 80 Fed. Reg. 2885. EPA proposed to make the exemption from notification requirements for persons who import the chemical substance as part of an article inapplicable for the import of a subset of LCPFAC chemical substances in all articles. The proposed supplemental SNUR would make the exemption from notification requirements inapplicable and require significant new use notification reporting for the import of a subset of LCPFAC chemical substances only as part of a surface coating on articles. According to EPA, this supplemental proposal “better defines the articles subject to the rule by defining the subject articles as ‘imported articles where certain LCPFAC chemical substances are part of surface coating on the articles’ rather than what was originally proposed, ‘imports of articles.’” EPA states that it is issuing the supplemental proposal to be responsive to the article consideration provision at TSCA Section 5(a)(5), added with the passage of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg), which states that articles can be subject to notification requirements as a significant new use if the Administrator makes an affirmative finding in a rule that the reasonable potential for exposure to a chemical from an article or category of articles justifies notification. Rather than making the article exemption inapplicable for any article, as EPA proposed in the 2015 proposed SNUR, the supplemental proposal proposes to make a finding under TSCA Section 5(a)(5) and make the article exemption at 40 C.F.R. Section 721.45(f) inapplicable for persons importing the category of articles that contain certain LCPFAC chemical substances as part of a surface coating on articles.

As to processors, EPA states that it understands that there is no ongoing manufacturing or processing of LCPFAC chemical substances in the United States. Based on that understanding, EPA does not expect that there would be any such processing in the future, and EPA therefore is not proposing that the proposed supplemental SNUR apply to processors. EPA seeks comment on this approach.

Companies that manufacture (including import), process, or distribute in commerce chemical substances and mixtures may be potentially affected by this action. EPA intends the following list of North American Industry Classification System (NAICS) codes to provide a guide to help readers determine whether the supplemental proposal applies to them. Potentially affected entities may include: Apparel Manufacturing (NAICS code 315); Electrical Equipment, Appliance, and Component Manufacturing (NAICS code 335); Merchant Wholesalers, Durable Goods (NAICS code 423); Merchant Wholesalers, Nondurable Goods (NAICS code 424); Furniture and Home Furnishings Stores (NAICS code 442); Electronics and Appliance Stores (NAICS code 443); Building Material and Garden Equipment and Supplies Dealers (NAICS code 444); Clothing and Clothing Accessories Stores (NAICS code 448); Sporting Goods, Hobby, Musical Instrument, and Book Stores (NAICS code 449); General Merchandise Stores (NAICS code 450); and Non-Store Retailers (NAICS code 451).

EPA states that during the public comment period for the 2015 proposed rule, it received comments about ongoing uses of LCPFAC and perfluorooctanoic acid (PFOA) chemical substances and requests that EPA modify the proposed SNUR to recognize and exclude specifically from the significant new uses certain ongoing activities. According to the notice, EPA “continues to review these claims of ongoing use to understand whether these uses remain ongoing.” EPA states that it intends to undertake further outreach to commenters to confirm and understand better the ongoing uses. In the final rule, EPA will recognize and exclude from the significant new uses any ongoing activities for these chemicals. The final rule would take final action on both the 2015 proposed rule and this supplemental proposal.

The supplemental proposal to the proposed SNUR would require persons who intend to import these LCPFAC chemical substances as part of a surface coating on articles for a significant new use, consistent with the requirements at 40 C.F.R. Section 721.25, to notify EPA at least 90 days before commencing such import. The supplemental proposal would furthermore preclude the commencement of import of such articles 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 notes that as discussed in an April 24, 1990, SNUR, it “has decided that the intent of the TSCA section 5(a)(1)(B) is best served by designating a use as a significant new use as of the date of publication of the proposed rule rather than as of the effective date of the final rule.” EPA published the proposed SNUR for LCPFAC and PFAS chemical substances in the Federal Register on January 21, 2015. EPA distinguishes uses arising after the publication of the proposed rule from uses that exist at publication of the proposed rule. The former would be new uses, the latter ongoing uses, except that uses that are ongoing as of the publication of the proposed rule would not be considered ongoing uses if they have ceased by the date of issuance of a final rule.

Commentary

This supplemental SNUR proposal has two primary goals. The first is to narrow the applicability voiding the article exemption for articles that contain LCPFACs. EPA appears confident that there are no ongoing uses of LCPFACs as surface coatings on articles (e.g., carpets, upholstered furniture). The second goal is to establish the ground rules for EPA’s consideration of the article exemption in future SNUR actions. Even if a company is not engaged in LCPFAC manufacturing, processing, or use, the company may wish to comment on this broader issue. This will help ensure that EPA establishes policies and procedures that both align with statutory requirements and also are workable, effective, predictable, transparent, and justified scientifically.

Use of LCPFACs as Surface Coatings

In 2015, EPA received comments from importers of more complex articles, such as electronics and vehicles, that LCPFACs may be present either intentionally or unintentionally and that the article importers would not necessarily know whether LCPFACs are or might be present. EPA states that it is still considering such comments and that the final SNUR will address such ongoing uses. B&C notes that EPA states it understands “there is no ongoing manufacturing or processing of LCPFAC chemical substances in the U.S.” and that “[b‌]ased on that understanding, EPA does not expect that there would be any future such processing, and EPA therefore is not proposing that this Supplemental Proposed Rule apply to processors.” EPA then specifically “seeks comment on this approach.” Although the proposal does not so state, B&C believes that EPA’s statement about “ongoing manufacturing or processing of LCPFAC chemical substances” relates specifically to processing of such substances as surface coatings on articles. This point warrants clarification by EPA; absent such clarity, entities that manufacture or process LCPFAC substances for uses other than as a surface coating for articles should ensure that their business interests are properly reflected in the record, even if the entities commented on the original rule. EPA states that it will consider and evaluate the various uses and include a consideration of ongoing uses along with the surface coating for articles use in the final rule.

Broad Consideration of the Article Exemption

Second, and perhaps more importantly for other TSCA reporters, EPA is using this proposal for LCPFACs used in surface coatings for articles as a test case for regulating articles under the new statutory requirements in Lautenberg. Lautenberg amended TSCA to require that EPA affirmatively find that there is a reasonable potential for exposure to a chemical substance through an article or category of article that would require notification. The statute is not specific as to how EPA must make such a determination, and EPA is seeking public input on how it should go about making that finding. B&C expects that EPA will rely on the use of LCPFACs to truth test the scope of this new TSCA provision.

First EPA requests comment on whether it should “affirmatively establish an explicit threshold at which, or explicit criteria for determining whether” a SNU exhibits a “reasonable potential for exposure” that justifies notification. Similarly, EPA seeks comment on whether it could establish a de minimis threshold for a “reasonable potential for exposure.” These two issues are related. Commenters should consider whether EPA should establish criteria that would apply in all cases, or if EPA should evaluate an explicit threshold and/or a de minimis level on a case-by-case basis. Such criteria might apply to a chemical substance or category of substances (e.g., an LCPFAC) or a particular circumstance of use of that substance (e.g., use as a surface coating). Commenters might also consider whether the substance being present as an impurity or byproduct would affect the appropriateness of a threshold or a de minimis level. Interested parties may wish to comment on the degree of knowledge that would trigger SNUR reporting -- would an importer have to test some subset of imported articles, would testing only be required if there is a reasonable expectation that the substance is present, and to what extent would an importer be required to query its upstream suppliers regarding the presence of the SNUR substance?

EPA also specifically requests input on whether its criteria for “reasonable potential for exposure” should be based on “typical conditions” or “laboratory experiments.” EPA is also considering whether it should require information from an importer to demonstrate the presence of the substance (LCPFAC) and for EPA to determine if the level is below a level needed to meet the “reasonable potential for exposure” threshold.