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December 27, 2011

EPA Scheduled to Publish Proposed SNURs for 17 Chemicals, Including CNTs

The ACTA Group

The U.S. Environmental Protection Agency (EPA) is scheduled to publish on December 28, 2011, proposed significant new use rules (SNUR) for 17 chemical substances that were the subject of premanufacture notices (PMN). According to EPA, 15 of the substances are subject to consent orders under Section 5(e) of the Toxic Substances Control Act (TSCA). Persons who intend to manufacture, import, or process any of the 17 substances for an activity that is designated as a significant new use by the proposed rules would be required to notify EPA at least 90 days before commencing that activity. Of particular interest, seven of the PMN substances’ reported chemical names include the term “carbon nanotube” (CNT) or “CNT.” Comments will be due 30 days after EPA publishes the proposed SNURs in the Federal Register. The prepublication notice is available online.

EPA states that because of a lack of established nomenclature for CNTs, the TSCA Inventory names for CNTs are currently in generic form, e.g., “carbon nanotube (CNT), multi-walled carbon nanotube (MWCNT), double-walled carbon nanotube (DWCNT), or single-walled carbon nanotube (SWCNT).” EPA uses the specific structural characteristics provided by the PMN submitter to characterize more specifically the TSCA Inventory listing for an individual CNT. According to EPA, all submitters of new chemical notices for CNTs have claimed those specific structural characteristics as confidential business information (CBI). The proposed rule includes the generic chemical name along with the PMN number to identify that a distinct chemical substance was the subject of the PMN without revealing the confidential chemical identity of the PMN substance.

EPA notes that, since confidentiality claims preclude a more detailed description of the identity of the CNTs, if an intended manufacturer, importer, or processor of CNTs is unsure of whether its CNTs are subject to the proposed SNURs, the company can either contact EPA or obtain a written determination from EPA pursuant to the bona fide procedures at 40 C.F.R. § 721.11. EPA states that it is using the specific structural characteristics, for all CNTs submitted as new chemical substances under TSCA, to help develop standard nomenclature for placing these chemical substances on the TSCA Inventory. EPA has compiled a generic list of those structural characteristics entitled “Material Characterization of Carbon Nanotubes for Molecular Identity (MI) Determination & Nomenclature.” According to EPA, a copy of this list will be available in the docket for the proposed SNURs under docket ID number EPA-HQ-OPPT-2010-0279.

Under TSCA Section 5(a)(2), EPA determines that a use of a chemical substance is a significant new use after considering all relevant factors, including:

  • The projected volume of manufacturing and processing of a chemical substance;
  • The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance;
  • The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance; and
  • The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.

EPA is also authorized to consider any other relevant factors. To determine what would constitute a significant new use for the 17 chemical substances that are the subject of the proposed SNURs, EPA states that it considered relevant information about the toxicity of the chemical substances, likely human exposures, and environmental releases associated with possible uses, taking into consideration the four factors listed above. According to EPA, the proposed rule includes 15 PMN substances for which EPA determined, pursuant to TSCA Section 5(e), that uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal may present an unreasonable risk of injury to human health or the environment. Accordingly, EPA states, these substances are subject to “risk-based” consent orders under TSCA Section 5(e)(1)(A)(ii)(I). The consent orders require protective measures intended to limit exposures or otherwise mitigate the potential unreasonable risk. The so-called “5(e) SNURs” for these PMN substances are proposed pursuant to 40 C.F.R. § 721.160, and are based on and consistent with the provisions in the underlying consent orders. The 5(e) SNURs designate as a “significant new use” the absence of the protective measures required in the corresponding consent orders.