Source: https://www.federalregister.gov/documents/2012/02/08/2012-2909/modification-of-significant-new-uses-of-tris-carbamoyl-triazine
Timestamp: 2018-02-19 08:33:45
Document Index: 560211746

Matched Legal Cases: ['art 707', '§\u2009721', 'art 707', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', 'art 9', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721']

Federal Register :: Modification of Significant New Uses of Tris Carbamoyl Triazine
This final rule is effective March 9, 2012.
6476-6479 (4 pages)
https://www.federalregister.gov/d/2012-2909 https://www.federalregister.gov/d/2012-2909
EPA is finalizing an amendment to the significant new use rule (SNUR) under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for the chemical substance identified generically as tris carbamoyl triazine, which was the subject to premanufacture notice (PMN) P-95-1098. This action requires persons who intend to manufacture, import, or process the chemical substance for a use that is designated as a significant new use by this final rule to notify EPA at least 90 days before commencing that activity. EPA believes that this action is necessary because new uses of the chemical substance may be hazardous to human health. 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.
EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPPT-2011-0108. All documents in the docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave. NW., Washington, DC. The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number of the EPA/DC Public Reading Room is (202) 566-1744, and the telephone number for the OPPT Docket is (202) 566-0280. Docket visitors are required to show photographic identification, pass through a metal detector, and sign the EPA visitor log. All visitor bags are processed through an X-ray machine and subject to search. Visitors will be provided an EPA/DC badge that must be visible at all times in the building and returned upon departure.
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 the 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 an amendment to the SNUR for the chemical substance identified generically as tris carbamoyl triazine (PMN P-95-1098) codified at 40 CFR 721.9719. This final action requires persons who intend to manufacture, import, or process the chemical substance 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 August 3, 2011 (76 FR 46678) (FRL-8878-3). EPA received no public comments in response to the proposal. Therefore, the Agency is issuing a final SNUR, as proposed that:
2. Adds protection in the workplace requirements under § 721.63 for respiratory protection and alternative New Chemical Exposure Limit (NCEL) exposure monitoring to address the newly-identified potential risks from inhalation exposure in the workplace.
3. Revises the hazard communication requirements under § 721.72 to add the human health hazard and exposures and remove the environmental hazards and exposures.
4. Removes all release to water requirements under § 721.90.
5. Revises the recordkeeping requirements under § 721.125 to reflect the modified significant new uses.
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 the four bulleted TSCA section 5(a)(2) factors, listed in Unit IV. of this document. 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, import, or process the chemical substance for that use. Persons who must report are described in § 721.5.
During review of PMN P-95-1098, the chemical substance identified generically as tris carbamoyl triazine, 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 this chemical substance. The basis for such findings is outlined in Unit II. of the proposed rule to amend this SNUR, included in the Federal Register issue of August 3, 2011 (76 FR 46678) and in the Federal Register document of August 20, 1998 (63 FR 44562) (FRL-5788-7). Based on these findings, a TSCA section 5(e) consent order requiring the use of appropriate exposure controls was negotiated with the PMN submitter. The SNUR provisions for this chemical substance were consistent with the provisions of the original TSCA section 5(e) consent order. The SNUR was promulgated pursuant to § 721.160.
After the review of test data submitted pursuant to the TSCA section 5(e) consent order for PMN P-95-1098 (see Unit II. of the proposed rule) and consideration of the factors included in TSCA section 5(a)(2) (see Unit IV. of this document), EPA determined that the chemical substance may pose an unreasonable risk to human health, but also that the finding that certain activities involving the substance may present an unreasonable risk to the environment was no longer supported. Consequently, EPA is finalizing this modification to the SNUR at § 721.9719 according to procedures in § 721.160 and § 721.185, so that SNUR provisions for this chemical substance remain consistent with the provisions of the TSCA section 5(e) consent order, as modified.
In addition to these factors enumerated in TSCA section 5(a)(2), the statute authorizes EPA to consider any other relevant factors. To determine what would constitute a significant new use for the chemical substance identified generically as tris carbamoyl triazine (PMN P-95-1098), EPA considered relevant information about the toxicity of the chemical substance, likely human exposures and environmental releases associated with possible uses, taking into consideration the four bulleted TSCA section 5(a)(2) factors listed in this unit.
As discussed in the Federal Register issue of April 24, 1990 (55 FR 17376), EPA has decided that the intent of TSCA section 5(a)(1)(B) is best served by designating a use as a significant new use as of the date of publication of the proposed SNUR rather than as of the effective date of the final rule. If uses begun after publication were considered ongoing rather than new, it would be difficult for EPA to establish SNUR notice requirements, because a person could defeat the SNUR by initiating the proposed significant new use before the rule became effective, and then argue that the use was ongoing as of the effective date of the final rule.
EPA has promulgated provisions to allow persons to comply with this SNUR before the effective date. 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 this final SNUR for those activities.
EPA evaluated the potential costs of establishing SNUN requirements for potential manufacturers, importers, and processors of the chemical substance during the development of the direct final rule. The Agency's complete Economic Analysis is available in the docket under docket ID number EPA-HQ-OPPT-2011-0108.
According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., an Agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR part 9, and included on the related collection instrument or form, if applicable.
Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency hereby certifies that promulgation of this modified SNUR will not have a significant adverse economic impact on a substantial number of small entities. The rationale supporting this conclusion is discussed in this unit. The requirement to submit a SNUN applies to any person (including small or large entities) who intends to engage in any activity described in the rule as a “significant new use.” Because these uses are “new,” based on all information currently available to EPA, it appears that no small or large entities presently engage in such activities. A SNUR requires that any person who intends to engage in such activity in the future must first notify EPA by submitting a SNUN. Although some small entities may decide to pursue a significant new use in the future, EPA cannot presently determine how many, if any, there may be. However, EPA's experience to date is that, in response to the promulgation of SNURs covering over 1,000 chemicals, the Agency receives only a handful of notices per year. For example, the number of SNUNs was four in Federal fiscal year 2005, eight in FY 2006, six in FY 2007, eight in FY 2008, and seven in FY 2009. During this five-year period, three small entities submitted a SNUN. In addition, the estimated reporting cost for submission of a SNUN (see Unit VIII.) is minimal regardless of the size of the firm. Therefore, EPA believes that the potential economic impacts of complying with this modified SNUR is not expected to be significant or adversely impact a substantial number of small entities. In a SNUR that published in the Federal Register issue of June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency presented its general determination that final SNURs are not expected to have a significant economic impact on a substantial number of small entities, which was provided to the Chief Counsel for Advocacy of the Small Business Administration.
(i) Protection in the workplace. Requirements as specified in § 721.63 (a)(4), (a)(6)(v), (b) (concentration set at 1.0 percent), and (c). Respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 5. As an alternative to the respiratory requirements listed, a manufacturer, importer, or processor may choose to follow the new chemical exposure limit (NCEL) provisions listed in the Toxic Substances Control Act (TSCA) section 5(e) consent order for this substance. The NCEL is 1.0 mg/m3 as an 8-hour time weighted average. Persons who wish to pursue NCELs as an alternative to the § 721.63 respirator requirements may request to do so under § 721.30. Persons whose § 721.30 requests to use the NCELs approach are approved by EPA will receive NCELs provisions comparable to those contained in the corresponding section 5(e) consent order. The following NIOSH-certified respirators meet the requirements for § 721.63(a)(4):
[FR Doc. 2012-2909 Filed 2-7-12; 8:45 am]