Source: https://www.federalregister.gov/documents/2012/07/16/2012-17276/significant-new-use-rule-for-phenol-24--dimethyl-6-1-methylpentadecyl-
Timestamp: 2017-03-25 10:08:37
Document Index: 422294807

Matched Legal Cases: ['art 707', '§\u2009721', 'art 707', '§\u2009721', '§\u2009721', '§\u2009721', 'art 707', '§\u2009721', 'art 707', '§\u2009721', '§\u2009721', '§\u2009720', '§\u20099', '§\u20099', '§\u2009721', '§\u2009721', '§\u2009721']

:: Significant New Use Rule for Phenol, 2,4- dimethyl-6-(1-methylpentadecyl)-
41692-41697
https://www.federalregister.gov/d/2012-17276
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; see also 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 final 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 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.
1. Adds protection in the workplace requirements under § 721.63 for dermal protection.
2. Includes an exemption from the requirements under § 721.63 when the substance is present in a mixture less than 1.0 percent.
3. Removes all release to water requirements under § 721.90.
Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements promulgated in Customs and Border Patrol regulations at 19 CFR 12.118 through 12.127; see also 19 CFR 127.28. Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA. For importers of the chemical substance subject to this final SNUR those requirements include the SNUR. 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 the chemical substance 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.
During review of the PMN submitted for the chemical substance phenol, 2,4-dimethyl-6-(1-methylpentadecyl)-, EPA concluded that one or more of the criteria of concern established at § 721.170 were met, as discussed in Units II. and IV. of the proposed rule (76 FR 81437).
To determine what would constitute a significant new use for the chemical substance that is the subject to this final SNUR, EPA considered relevant information about the toxicity of the chemical substance, likely human exposure and environmental releases associated with possible uses, taking into consideration the four bulleted TSCA section 5(a)(2) factors listed in this unit, and the regulations at § 721.170 for issuing a SNUR after receipt of a PMN.
In the absence of a TSCA section 4 test rule or a TSCA section 5(b)(4) listing covering the chemical substance, persons are required only to submit test data in their possession or control and to describe any other data known to or reasonably ascertainable by them (see § 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. Unit IV. of the proposed rule lists the testing recommended by EPA for the chemical substance phenol, 2,4 dimethyl-6-(1-methylpentadecyl)-. Specifically, EPA has determined that a dermal absorption study (Office of Pollution Prevention and Toxics (OPPTS) Test Guideline 870.3250) would help characterize the health effects of the PMN substance. 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 and test reporting. To access the harmonized test guidelines referenced in this document electronically, please go to http://www.epa.gov/ocspp and select “Test Methods and Guidelines.”
2. The table in § 9.1 is amended by adding the following section in numerical order under the undesignated center heading “Significant New Uses of Chemical Substances” to read as follows: § 9.1 OMB approvals under the Paperwork Reduction Act.
40 CFR CitationOMB Control No. * * * * *Significant New Uses of Chemical Substances* * * * * 721.57252070-0012 * * * * * * * * * *
4. Add § 721.5725 to subpart E to read as follows: § 721.5725 Phenol, 2,4-dimethyl-6-(1-methylpentadecyl)-.
(i) Protection in the workplace. Requirements as specified in § 721.63 (a)(2)(i), (a)(3), and (b) (concentration set at 1.0 percent).