Regulatory DevelopmentsMarch 20, 2012
The U.S. Environmental Protection Agency (EPA) released on March 20, 2012, proposed significant new use rules (SNUR) that would require companies to report all new uses of five groups of chemicals, including in domestic and imported products and articles, to give EPA the opportunity, if warranted, to prohibit or limit the activity. The chemicals, which were part of the existing chemical action plans that EPA released in 2009 through 2011, are polybrominated diphenylethers (PBDE), hexabromocyclododecane (HBCD), benzidine dyes, short-chain chlorinated paraffins (SCCP), and di-n-pentyl phthalate (DnPP). EPA is also proposing additional testing on the health and environmental effects of PBDEs. The proposed rules were signed March 20, 2012, and have not yet been published in the Federal Register. The proposal reflects EPA's continuing use of existing Toxic Substances Control Act (TSCA) authorities to achieve the Administration's commitment to enhanced chemical management.
Under the proposed rule, EPA would amend the PBDE SNUR to designate processing of any combination of the six PBDE congeners contained in commercial pentabromodiphenyl ether (c-pentaBDE) or commercial octabromodiphenyl ether (c-octaBDE) for any use that is not ongoing as a significant new use. The proposed rule would also designate manufacturing, importing, or processing of decaBDE for any use that is not ongoing after December 31, 2013, as a significant new use, and would designate the manufacture (including import) or processing of any article to which PBDEs had been added a significant new use. Any person who intended to import a PBDE as part of an article for a significant new use would be subject to significant new use reporting. Ongoing uses would be excluded from the SNUR. Comments will be due 60 days after EPA publishes the proposed rule in the Federal Register. The pre-publication notice is available online. More information on EPA's action plan for PBDEs is available online.
The proposed rule simultaneously proposes a TSCA Section 4 test rule for c-pentaBDE, c-octaBDE, and commercial decabromodiphenyl ether (c-decaBDE). The test rule would require development of information EPA believes necessary to determine the effects of manufacturing, processing, or other activities involving these c-PBDEs on human health or the environment. EPA states that it intends to promulgate the test rule if it determines that manufacture (including import) or processing of c-PBDEs, including in articles, has not ceased by December 31, 2013.
The proposed SNUR for HBCD would designate "use in consumer textiles, other than for use in motor vehicles" as a significant new use. Persons who intend to manufacture (including import) or process HBCD for use in covered consumer textiles would be required to notify EPA at least 90 days before commencing that activity. For this proposed rule, EPA states that the general SNUR article exemption for persons who import or process chemical substances as part of an article would not apply. Comments will be due 60 days after EPA publishes the proposed rule in the Federal Register. The pre-publication notice is available online. More information on EPA's action plan for HBCD is available online.
Benzidine Dyes, DnPP, and SCCPs
The proposed rule would add nine benzidine-based chemical substances to the SNUR at 40 C.F.R. Section 721.1660 on benzidine-based chemical substances; create a SNUR for DnPP; and create a SNUR for alkanes, C12-13, chloro. In the case of the benzidine-based chemical substances, EPA is also proposing to make inapplicable the exemption at 40 C.F.R. Section 721.45(f) relating to persons that import or process substances as part of an article. This would require persons who intend to import or process all listed benzidine-based chemical substances, i.e., the newly proposed nine benzidine-based chemical substances, as well as the currently listed benzidine-based chemical substances, as part of an article to notify EPA at least 90 days before commencing that activity. Although EPA states in its press release that comments on all proposed rules will be due 60 days after publication in the Federal Register, the pre-publication version of this rule states that comments will be due 90 days after publication in the Federal Register. The pre-publication notice is available online. More information on EPA's action plan for benzidine dyes is available online. EPA's action plan for phthalates, including DnPP, is available online. EPA's action plan for SCCPs is available online.
These proposals represent important steps by EPA to act on several of its action plan commitments. Several of the SNURs are groundbreaking in their inclusion of processing as a significant new use (e.g., the PBDEs) and their inclusion of manufactured articles wherein EPA is proposing not to apply the exemption of articles that otherwise applies by default to SNURs. These proposed rules represent an important body of work that will need close scrutiny by affected entities.
The proposal is noteworthy for another reason. With respect to the PBDEs SNUR, even when EPA is aware of some ongoing uses of decaBDE (e.g., in "military and aeronautical uses"), EPA has chosen not to exclude those uses from the proposed SNUR's coverage in the regulatory text: the proposed SNUR trigger for decaBDE is "[m]anufacture, importing, or processing for any use after December 31, 2013." Importantly, EPA places the burden squarely on commenters to explain "the extent to which these uses will continue...and whether there are any other uses which will not be discontinued by December 31, 2013." In discussing this aspect of the proposal, EPA asks for details on the ongoing uses and requests definitions of terms. This seems to suggest that EPA will narrowly define any ongoing uses based on the information provided in comments. It will be very important for information on any ongoing uses provided to EPA to be comprehensive in its coverage and to be described carefully.
Another interesting aspect is the extent to which recycling of the PBDEs will be important after 2013. Recycling is considered "processing" and thus, if any entity intends to continue such recycling, that entity would need to inform EPA in comments submitted on the proposal. Because EPA has also proposed a test rule for the PBDEs, any comments about ongoing uses or processing (and the magnitude (volume) of such activities) would be considered by EPA in preparing the test rule in final.
For the test rule on the PBDEs, EPA is relying on the "may present" finding. This means that EPA could proceed with the testing requirements even if the production volume does not meet the exposure-based policy's trigger of 1 million pounds. This approach may increase the likelihood that a test rule action may be issued in final, depending on the ongoing production and processing of the PBDEs, particularly decaBDE. In this regard, it is important to note that in preparing the proposal in final, EPA would still have to consider the economic affordability of the testing to be required.