Significant New Use Rules on Certain Chemical Substances
AGENCY: Environmental Protection Agency (EPA).
40 CFR Parts 9 and 721 [EPA-HQ-OPPT-2010-0279; FRL-9390-6] RIN 2070-AB27
ACTION: Final rule.
SUMMARY: EPA is finalizing significant new use rules (SNURs) under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for 17 chemical substances which were the subject of premanufacture notices (PMNs). Fifteen of these chemical substances are subject to TSCA section 5(e) consent orders issued by EPA. This action would require
persons who intend to manufacture, or process any of these 17 chemical substances for an activity that is designated as a significant new use by this proposed rule to notify EPA at least 90 days before commencing that activity. The required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs.
II. Background
A. What Action is the Agency Taking?
EPA is finalizing SNURs under TSCA section 5(a)(2) for 17 chemical substances which were the subject of PMNs. Fifteen of these chemical substances are subject to TSCA section 5(e) consent orders issued by EPA. The final SNURs for these substances are based on and consistent with the provisions in the underlying consent order. The final SNURs designate as a significant new use manufacture (including import) or processing 4in the absence of the protective measures required in the corresponding consent order. The final SNURs for the 2 remaining substances are not subject to a consent order under TSCA section 5(e). In these two cases, EPA has determined in the final SNURs that these significant new use activities, "(i) are different from those described in the premanufacture notice for the substance, including any amendments, deletions, and additions of activities to the premanufacture notice, and (ii) may be accompanied by changes in exposure or release levels that are significant in relation to the health or environmental concerns identified" for the PMN substance. This action requires persons who intend to manufacture, or process these chemical substances for an activity that is designated as a significant new use by this final rule to notify EPA at least 90 days before commencing that activity.
Previously, in the Federal Register issue of December 28, 2011 (76 FR 81447) (FRL–9326–2), EPA proposed SNURs for these seventeen chemical substances More information on the specific chemical substances subject to this final rule can be found in the Federal Register documents proposing the SNURs. The record for the SNURs for these seventeen chemical substances was established in the docket under docket ID number EPA–HQ–OPPT–2010–0279. That docket includes information considered by the Agency in developing the proposed and final rules, including comments on those rules.
EPA received numerous comments on the proposed rule. A full discussion of EPA's response to these comments is included in Unit V. of this document. Based on these comments, EPA is issuing modified final rules for these chemical substances as described in Unit V. of this document. 5
B. What is the Agency's Authority for Taking this Action?
Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a "significant new use." EPA must make this determination by rule after considering all relevant factors, including those listed in TSCA section 5(a)(2). Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1)(B) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture, or process the chemical substance for that use. Persons who must report are described in §721.5.
Final Rule filed for public inspection on Jun 25, 2013
Next Steps This pre-release document will be published on Jun 26, 2013.
Resources Visit the Federal Register for much more information.
Full Text Read the full text (PDF) of this document here: