Source: https://www.federalregister.gov/documents/2013/09/11/2013-22112/significant-new-use-rule-on-certain-chemical-substances
Timestamp: 2017-11-24 11:44:37
Document Index: 17929296

Matched Legal Cases: ['§\u2009721', 'art 707', '§\u2009721', 'art 707', '§\u2009721', '§\u2009721', 'art 721', 'art 700', '§\u200914', 'art 720', '§\u200914', '§\u2009721', '§\u2009721']

This final rule is effective October 11, 2013.
55632-55635 (4 pages)
FRL-9398-7
https://www.federalregister.gov/d/2013-22112 https://www.federalregister.gov/d/2013-22112
Under the Toxic Substances Control Act (TSCA), EPA is finalizing the significant new use rule (SNUR) for three chemical substances which were the subject of premanufacture notices (PMNs) and subject to a TSCA section 5(e) consent order issued by EPA. This action requires persons who intend to manufacture (including import) or process any of these three 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. The required notification will provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs.
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPPT-2011-0941, is available at http://www.regulations.gov or at the Office of Pollution Prevention and Toxics Docket (OPPT Docket), Environmental Protection Agency Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPPT Docket is (202) 566-0280. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/​dockets.
You may be potentially affected by this action if you manufacture, process, or use the chemical substances contained in this final rule. Potentially affected entities may include, but are not limited to:
This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in § 721.5. If you have questions regarding the applicability of this action to a particular entity, consult the technical person listed under FOR FURTHER INFORMATION CONTACT.
This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements promulgated at 19 CFR 12.118 through 12.127 and 19 CFR 127.28. Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA. Importers of chemicals subject to a SNUR must certify their compliance with the SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export a chemical substance that is the subject of a proposed or final SNUR are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see § 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D.
EPA is finalizing a SNUR under TSCA section 5(a)(2) for three chemical substances that were the subject of PMNs and subject to a TSCA section 5(e) consent order issued by EPA. The SNUR is codified at 40 CFR 721.10515. The final SNUR designates as a significant new use manufacture (including import) or processing in the presence of the restrictions required in the consent order. The final SNUR for these substances is based on and consistent with the provisions in the underlying consent order. This final action requires persons who intend to manufacture or process the 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.
This rule was proposed in the Federal Register issue of January 23, 2013 (78 FR 4806) (FRL-6369-9). EPA received no public comments in response to the proposal for PMNs P-10-58, P-10-59, and P-10-60. Therefore, the Agency is issuing a final SNUR, as proposed that:
EPA did receive and comments on the remaining chemical substance in the proposed rule, PMN P-07-0204 (§ 721.10509), and will address that in a future, separate 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.
General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, Start Printed Page 55633and applicability of the final rule to uses occurring before the effective date of the final rule. Provisions relating to user fees appear at 40 CFR part 700. According to § 14;721.1(c), persons subject to these SNURs must comply with the same SNUN requirements and EPA regulatory procedures as submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these requirements include the information submission requirements of TSCA section 5(b) and 5(d)(1), the exemptions authorized by TSCA sections 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA may take regulatory action under TSCA section 5(e), 5(f), 6, or 7 to control the activities for which it has received the SNUN. If EPA does not take action, EPA is required under TSCA section 5(g) to explain in the Federal Register its reasons for not taking action.
During review of the PMNs submitted for the three chemical substances, EPA concluded that regulation was warranted under TSCA section 5(e), pending the development of information sufficient to make reasoned evaluations of the health or environmental effects of the chemical substances. Based on these findings, a TSCA section 5(e) consent order requiring the use of appropriate exposure controls were negotiated with the PMN submitter. The SNUR provisions for these chemical substances are consistent with the provisions of the TSCA section 5(e) consent order. This SNUR is promulgated pursuant to § 14;721.160. See the docket under docket ID number EPA-HQ-OPPT-2011-0941 for the corresponding consent orders.
EPA is issuing this final SNUR for specific chemical substances which have undergone premanufacture review because the Agency wants to achieve the following objectives with regard to the significant new uses designated in this final rule:
In addition to these factors enumerated in TSCA section 5(a)(2), the statute authorized EPA to consider any other relevant factors. To determine what would constitute a significant new use for the three chemical substances that are the subject of this SNUR, EPA considered relevant information about the toxicity of the chemical substances, likely human exposures and environmental releases associated with possible uses, and the four bulleted TSCA section 5(a)(2) factors listed in this unit.
If uses begun after the proposed rule was published were considered ongoing rather than new, any person could defeat the SNUR by initiating the significant new use before the final rule was issued. Therefore, EPA has designated the date of publication of the proposed rule as the cutoff date for determining whether the new use is ongoing. Consult the Federal Register document of April 24, 1990 (55 FR 17376) (FRL-3658-5) for a more detailed discussion of the cutoff date for ongoing uses.
Any person, who began commercial manufacture or processing of the chemical substances for any of the significant new uses designated in the proposed SNUR after the date of publication of the proposed SNUR, must stop that activity before the effective date of the final rule. Persons who ceased those activities will have to first comply with all applicable SNUR notification requirements and wait until the notice review period, including any extensions, expires, before engaging in any activities designated as significant new uses. If a person were to meet the conditions of advance compliance under § 721.45(h), the person would be considered to have met the requirements of the final SNUR for those activities.
In the TSCA section 5(e) consent orders for the chemical substances regulated under this final rule, EPA has established restrictions in view of the lack of data on the potential health and environmental risks that may be posed by the significant new uses or increased exposure to the chemical substances. These restrictions will not be removed until EPA determines that the unrestricted use will not present an unreasonable risk of injury or result in significant or substantial exposure or environmental release. This determination is usually made based on the results of the required or recommended toxicity tests. In cases where EPA issued a TSCA section 5(e) Start Printed Page 55634consent order that requires or recommends certain testing, Unit IV. of the proposed rule lists tests required or recommended in each of the section 5(e) consent orders underlying the proposed section 5(e) SNURs. Descriptions of tests are provided for informational purposes. EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol selection.
EPA has evaluated the potential costs of establishing SNUN requirements for potential manufacturers and processors of the chemical substances during the development of the direct final rule. EPA's complete economic analysis is available in the docket under docket ID number EPA-HQ-OPPT-2011-0941.
This final rule establishes a SNUR for three new chemical substances that were the subject of PMNs and a TSCA section 5(e) consent order. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993).
This final rule does not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This final rule does not significantly nor uniquely affect the communities of Indian Tribal governments, nor does it involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175, entitled “Consultation and Coordination Start Printed Page 55635with Indian Tribal Governments” (65 FR 67249, November 9, 2000), do not apply to this final rule.
4. Add § 721.10515 to subpart E to read as follows:
[FR Doc. 2013-22112 Filed 9-10-13; 8:45 am]