Modification of Significant New Uses of Ethaneperoxoic Acid, 1,1-Dimethylpropyl Ester, 46283-46287 [2013-18180]

Download as PDF 46283 Federal Register / Vol. 78, No. 147 / Wednesday, July 31, 2013 / Rules and Regulations Significantly Affect Energy Supply, Distribution, or Use’’ (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled ‘‘Protection of Children from Environmental Health Risks and Safety Risks’’ (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled ‘‘Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations’’ (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition submitted under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply. This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled ‘‘Federalism’’ (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled ‘‘Consultation and Coordination with Indian Tribal Governments’’ (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA) (15 U.S.C. 272 note). VII. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: July 22, 2013. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. 2. In § 180.569, revise paragraphs (a)(1) introductory text and (a)(2) to read as follows: ■ § 180.569 Forchlorfenuron; tolerances for residues. (a) General. (1) Tolerances are established for residues of forchlorfenuron, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only forchlorfenuron (N-(2chloro-4-pyridinyl)-N′-phenylurea). * * * * * (2) Temporary tolerances are established for residues of forchlorfenuron, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring on forchlorfenuron (N-(2chloro-4-pyridinyl)-N′-phenylurea). Parts per million Commodity Almond ..................................................................................................................................................................... Almond, hulls ........................................................................................................................................................... Cherry, sweet ........................................................................................................................................................... Fig ............................................................................................................................................................................ Pear ......................................................................................................................................................................... Pistachio .................................................................................................................................................................. Plum, prune, fresh ................................................................................................................................................... * * * * * [FR Doc. 2013–18182 Filed 7–30–13; 8:45 am] ENVIRONMENTAL PROTECTION AGENCY BILLING CODE 6560–50–P 40 CFR Part 721 [EPA–HQ–OPPT–2012–0864; FRL–9392–4] ehiers on DSK2VPTVN1PROD with RULES RIN 2070–AB27 Modification of Significant New Uses of Ethaneperoxoic Acid, 1,1Dimethylpropyl Ester Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: VerDate Mar<15>2010 14:07 Jul 30, 2013 Jkt 229001 PO 00000 Frm 00035 Fmt 4700 Sfmt 4700 0.01 0.15 0.01 0.01 0.01 0.01 0.01 Expiration/ revocation date 12/31/15 12/31/15 12/31/15 12/31/15 12/31/15 12/31/15 12/31/15 Under the Toxic Substances Control Act (TSCA), EPA is finalizing an amendment to the significant new use rule (SNUR) for the chemical substance identified as ethaneperoxoic acid, 1,1dimethylpropyl ester, which was the subject of premanufacture notice (PMN) P–85–680. This action requires persons who intend to manufacture 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 SUMMARY: E:\FR\FM\31JYR1.SGM 31JYR1 46284 Federal Register / Vol. 78, No. 147 / Wednesday, July 31, 2013 / Rules and Regulations ehiers on DSK2VPTVN1PROD with RULES 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. DATES: This final rule is effective August 30, 2013. ADDRESSES: The docket for this action, identified by docket identification (ID) number EPA–HQ–OPPT–2012–0864, is available at https://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 https:// www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: For technical information contact: Jim Alwood, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001; telephone number: (202) 564–8974; email address: alwood.jim@epa.gov. For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554– 1404; email address: TSCAHotline@epa.gov. SUPPLEMENTARY INFORMATION: I. Does this action apply to me? You may be potentially affected by this action if you manufacture, process, or use the chemical substance identified as ethaneperoxoic acid, 1,1dimethylpropyl ester, (PMN P–85–680). Potentially affected entities may include, but are not limited to: Manufacturers or processors of the subject chemical substance (NAICS codes 325 and 324110), e.g., chemical manufacturing and petroleum refineries. 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 VerDate Mar<15>2010 14:07 Jul 30, 2013 Jkt 229001 you or your business may be affected by this action, you should carefully examine the applicability provisions in § 721.5. If you have any 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 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. II. Background A. What action is the agency taking? EPA is finalizing an amendment to the SNUR for the chemical substance identified as ethaneperoxoic acid, 1,1dimethylpropyl ester, (PMN P–85–680), codified at 40 CFR 721.3020. This final action requires persons who intend to manufacture 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 January 28, 2013 (78 FR 5761) (FRL–9370–5). EPA received no public comments in response to the proposal. Therefore, the Agency is issuing a final SNUR, as proposed that: 1. Removes the significant new use requirements for protective equipment, hazard communication, and specific uses identified in the consent order. 2. Modifies significant new use requirements for environmental releases by removing notification requirements for disposal and adding notification requirements for water releases above 61 parts per billion (ppb). 3. Revises the recordkeeping requirements to reflect the modified SNUR requirements. PO 00000 Frm 00036 Fmt 4700 Sfmt 4700 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 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 or process the chemical substance for that use. Persons who must report are described in § 721.5. III. Rationale for the Rule During review of PMN P–85–680, the chemical substance identified as ethaneperoxoic acid, 1,1dimethylpropyl ester, 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 January 28, 2013 (78 FR 5761) (‘‘proposed amended rule’’), and in the original final rule Federal Register document of June 26, 1990 (55 FR 26102). Based on these findings, a TSCA section 5(e) consent order requiring the use of hazard communication and appropriate exposure, use, and disposal 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, and codified at § 721.1560 and redesignated as § 721.3020. After the review of new test data subsequent to issuance of the TSCA section 5(e) consent order for P–85–680 and associated SNUR (see Unit II. of the proposed amended rule), and consideration of the factors included in TSCA section 5(a)(2) (see Unit IV.), EPA determined that the chemical substance meets one or more of the concern criteria in § 721.170(b), but that these criteria are no longer met for the personal protective equipment, hazard communication, and specific use notification requirements. Consequently, EPA is proposing this modification to the SNUR at § 721.3020 according to procedures in §§ 721.160 and 721.185. E:\FR\FM\31JYR1.SGM 31JYR1 Federal Register / Vol. 78, No. 147 / Wednesday, July 31, 2013 / Rules and Regulations IV. Significant New Use Determination Section 5(a)(2) of TSCA states that EPA’s determination that a use of a chemical substance is a significant new use must be made after consideration of 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. • The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance. 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 as ethaneperoxoic acid, 1,1dimethylpropyl ester, (PMN P–85–680), 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. ehiers on DSK2VPTVN1PROD with RULES V. Applicability of the Significant New Use Designation 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) for a more detailed discussion of the cutoff date for ongoing uses. Any person who began commercial manufacture or processing of the chemical substance identified as ethaneperoxoic acid, 1,1dimethylpropyl ester, (PMN P–85–680), for any of the significant new uses designated in the proposed SNUR modification 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 VerDate Mar<15>2010 14:07 Jul 30, 2013 Jkt 229001 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. VI. Test Data and Other Information EPA recognizes that TSCA section 5 does not require the development of any particular test data before submission of a SNUN. There are two exceptions: 1. Development of test data is required where the chemical substance subject to the SNUR is also subject to a test rule under TSCA section 4 (see TSCA section 5(b)(1)). 2. Development of test data may be necessary where the chemical substance has been listed under TSCA section 5(b)(4) (see TSCA section 5(b)(2)). 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. In this case, EPA recommends persons, before performing any testing, to consult with the Agency pertaining to protocol selection. The recommended testing specified in Unit II.A. of the proposed rule may not be the only means of addressing the potential risks of the chemical substance. However, SNUNs submitted without any test data may increase the likelihood that EPA will take action under TSCA section 5(e), particularly if satisfactory test results have not been obtained from a prior PMN or SNUN submitter. EPA recommends that potential SNUN submitters contact EPA early enough so that they will be able to conduct the appropriate tests. SNUN submitters should be aware that EPA will be better able to evaluate SNUNs which provide detailed information on the following: • Human exposure and environmental release that may result from the significant new use of the chemical substances. • Potential benefits of the chemical substances. • Information on risks posed by the chemical substances compared to risks posed by potential substitutes. VII. SNUN Submissions According to § 721.1(c), persons submitting a SNUN must comply with the same notice requirements and EPA regulatory procedures as persons PO 00000 Frm 00037 Fmt 4700 Sfmt 4700 46285 submitting a PMN, including submission of test data on health and environmental effects as described in § 720.50. SNUNs must be on EPA Form No. 7710–25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in §§ 721.25 and 720.40. E–PMN software is available electronically at https://www.epa.gov/opptintr/newchems. VIII. Economic Analysis EPA evaluated the potential costs of establishing SNUN requirements for potential manufacturers 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–2012–0864. IX. Statutory and Executive Order Reviews A. Executive Order 12866 This action modifies a SNUR for a chemical substance that is the subject of a PMN and 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). B. Paperwork Reduction Act 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. EPA has amended the table in 40 CFR part 9 to list the OMB approval number for the information collection requirements contained in this rule. This listing of the OMB control numbers and their subsequent codification in the CFR satisfies the display requirements of PRA and OMB’s implementing regulations at 5 CFR part 1320. The information collection requirements related to this action have already been approved by OMB pursuant to PRA under OMB control number 2070–0012 (EPA ICR No. 574). This action does not impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated E:\FR\FM\31JYR1.SGM 31JYR1 46286 Federal Register / Vol. 78, No. 147 / Wednesday, July 31, 2013 / Rules and Regulations to average between 30 and 170 hours per response. This burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete, review, and submit the required SNUN. Send any comments about the accuracy of the burden estimate, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques, to the Director, Collection Strategies Division, Office of Environmental Information (2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001. Please remember to include the OMB control number in any correspondence, but do not submit any completed forms to this address. ehiers on DSK2VPTVN1PROD with RULES C. Regulatory Flexibility Act On February 18, 2012, EPA certified pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), that promulgation of a SNUR does not have a significant economic impact on a substantial number of small entities where the following are true: 1. A significant number of SNUNs would not be submitted by small entities in response to the SNUR. 2. The SNUN submitted by any small entity would not cost significantly more than $8,300. A copy of that certification is available in the docket for this rule. This rule is within the scope of the February 18, 2012 certification. Based on the Economic Analysis discussed in Unit VIII. and EPA’s experience promulgating SNURs (discussed in the certification), EPA believes that the following are true: • A significant number of SNUNs would not be submitted by small entities in response to the SNUR. • Submission of the SNUN would not cost any small entity significantly more than $8,300. Therefore, the promulgation of the SNUR would not have a significant economic impact on a substantial number of small entities. D. Unfunded Mandates Reform Act Based on EPA’s experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or Tribal government will be impacted by this final rule. As such, EPA has determined that this final rule does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any affect on small governments subject to the VerDate Mar<15>2010 14:07 Jul 30, 2013 Jkt 229001 requirements of sections 202, 203, 204, or 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104–4). E. Executive Order 13132 This action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). F. Executive Order 13175 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 With Indian Tribal Governments (65 FR 67249, November 9, 2000), do not apply to this final rule. J. Executive Order 12898 This action does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994). X. Congressional Review Act (CRA) Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 721 Environmental protection, Chemicals, Hazardous substances, Reporting and recordkeeping requirements. Dated: July 16, 2013. Maria J. Doa, Director, Chemical Control Division, Office of Pollution Prevention and Toxics. Therefore, 40 CFR part 721 is amended as follows: G. Executive Order 13045 PART 721—[AMENDED] This action is not subject to Executive Order 13045, entitled Protection of Children From Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), because this is not an economically significant regulatory action as defined by Executive Order 12866, and this action does not address environmental health or safety risks disproportionately affecting children. ■ H. Executive Order 13211 This action is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001), because this action is not expected to affect energy supply, distribution, or use and because this action is not a significant regulatory action under Executive Order 12866. I. National Technology Transfer and Advancement Act In addition, since this action does not involve any technical standards, section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104–113, section 12(d) (15 U.S.C. 272 note), does not apply to this action. PO 00000 Frm 00038 Fmt 4700 Sfmt 4700 1. The authority citation for part 721 continues to read as follows: Authority: 15 U.S.C. 2604, 2607, and 2625(c). 2. Amend § 721.3020 as follows: a. Revise the section heading. b. Revise paragraphs (a)(1) and (a)(2)(i). ■ c. Remove and reserve paragraph (a)(2)(ii) and remove paragraphs (a)(2)(iii) and (iv). ■ d. Revise paragraph (b)(1). ■ e. Remove paragraph (b)(3). The revisions read as follows: ■ ■ ■ § 721.3020 Ethaneperoxoic acid, 1,1dimethylpropyl ester. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as ethaneperoxoic acid, 1,1dimethylpropyl ester (PMN P–85–680; CAS No. 690–83–5) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) * * * (i) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N=61). (ii) [Reserved] (b) * * * (1) Recordkeeping. Recordkeeping requirements as specified in E:\FR\FM\31JYR1.SGM 31JYR1 Federal Register / Vol. 78, No. 147 / Wednesday, July 31, 2013 / Rules and Regulations § 721.125(a), (b), (c), and (k) are applicable to manufacturers and processors of this substance. * * * * * [FR Doc. 2013–18180 Filed 7–30–13; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 48 CFR Parts 1504, 1509, 1511, 1516, 1522, 1523, 1528, and 1552 [EPA–HQ–OARM–2013–0294 FRL 9837–4] Administrative Revisions to EPAAR Environmental Protection Agency. ACTION: Direct final rule. AGENCY: The EPA is taking direct final action on administrative changes to the EPA Acquisition Regulation (EPAAR). This action revises the EPAAR, but does not impose any new requirements on Agency contractors. The revisions in this direct final rule will make minor corrections to and streamline Agency acquisition processes to be consistent with and non-duplicative of the Federal Acquisition Regulation (FAR). EPA is issuing a final rule because the changes are administrative in nature and does not anticipate receiving adverse comments. SUMMARY: This rule is effective September 30, 2013 without further action, unless adverse comment is received by August 30, 2013. If adverse comment is received, the EPA will publish a timely withdrawal of the rule in the Federal Register. DATES: Submit your comments, identified by Docket ID No. EPA–HQ– OARM–2013–0294, by one of the following methods: • https://www.regulations.gov: Follow the on-line instructions for submitting comments. • Email: docket.oei@epa.gov. • Fax: (202) 566–1753. • Mail: EPA–HQ–OARM–2013–0294, OEI Docket, Environmental Protection Agency, 2822T, 1200 Pennsylvania Ave. NW., Washington, DC 20460. Please include a total of three (3) copies. • Hand Delivery: EPA Docket CenterAttention OEI Docket, EPA West, Room B102, 1301 Constitution Ave. NW., Washington, DC 20004. Such deliveries are only accepted during the Docket’s normal hours of operation, and special arrangements should be made for deliveries of boxed information. Instructions: Direct your comments to Docket ID No. EPA–HQ–OARM–2013– 0294. EPA’s policy is that all comments ehiers on DSK2VPTVN1PROD with RULES ADDRESSES: VerDate Mar<15>2010 17:54 Jul 30, 2013 Jkt 229001 received will be included in the public docket without change, and may be made available online at https:// www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through https:// www.regulations.gov or email. The https://www.regulations.gov Web site is an ‘‘anonymous access’’ system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an email comment directly to EPA without going through www.regulations.gov, your email address will be automatically captured and included as part of the comment that is placed in the public docket, and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment, and with any disk or CD–ROM you submit. If EPA cannot read your comment due to technical difficulties, and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. For additional information about EPA’s public docket, visit the EPA Docket Center homepage at https:// www.epa.gov/epahome/dockets.htm. Docket: All documents in the docket are listed in the https:// www.regulations.gov index. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically in https:// www.regulations.gov Federal Register, or in hard copy at the Government Property-Contract Property Administration Docket, EPA/DC, EPA West, Room 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 EPA Docket Center is (202) 566–1752. This Docket Facility is open from 8:30 a.m. to 4:30 p.m., PO 00000 Frm 00039 Fmt 4700 Sfmt 4700 46287 Monday through Friday, excluding legal holidays. FOR FURTHER INFORMATION CONTACT: Daniel Humphries, Policy, Training and Oversight Division, Office of Acquisition Management (3802R), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: 202–564– 4377; email address: humphries.daniel@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information 1. Submitting Classified Business Information (CBI). Do not submit this information to EPA through https:// www.regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD–ROM that you mail to EPA, mark the outside of the disk or CD–ROM as CBI, and then identify electronically within the disk or CD–ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR Part 2. 2. Tips for Preparing Your Comments. When submitting comments, remember to: • Identify the rulemaking by docket number and other identifying information (subject heading, Federal Register date and page number). • Follow directions—The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number. • Explain why you agree or disagree, suggest alternatives, and substitute language for your requested changes. • Describe any assumptions and provide any technical information and/ or data that you used. • If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced. • Provide specific examples to illustrate your concerns, and suggest alternatives. • Explain your views as clearly as possible, avoiding the use of profanity or personal threats. • Make sure to submit your comments by the comment period deadline identified. E:\FR\FM\31JYR1.SGM 31JYR1

Agencies

[Federal Register Volume 78, Number 147 (Wednesday, July 31, 2013)]
[Rules and Regulations]
[Pages 46283-46287]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-18180]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2012-0864; FRL-9392-4]
RIN 2070-AB27


Modification of Significant New Uses of Ethaneperoxoic Acid, 1,1-
Dimethylpropyl Ester

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: Under the Toxic Substances Control Act (TSCA), EPA is 
finalizing an amendment to the significant new use rule (SNUR) for the 
chemical substance identified as ethaneperoxoic acid, 1,1-
dimethylpropyl ester, which was the subject of premanufacture notice 
(PMN) P-85-680. This action requires persons who intend to manufacture 
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

[[Page 46284]]

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.

DATES: This final rule is effective August 30, 2013.

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPPT-2012-0864, is available at 
https://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 
https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For technical information contact: Jim 
Alwood, Chemical Control Division (7405M), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: 
(202) 564-8974; email address: alwood.jim@epa.gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. Does this action apply to me?

    You may be potentially affected by this action if you manufacture, 
process, or use the chemical substance identified as ethaneperoxoic 
acid, 1,1-dimethylpropyl ester, (PMN P-85-680). Potentially affected 
entities may include, but are not limited to:
    Manufacturers or processors of the subject chemical substance 
(NAICS codes 325 and 324110), e.g., chemical manufacturing and 
petroleum refineries.
    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 Sec.  721.5. If you 
have any 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 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 Sec.  721.20), and must comply with the export 
notification requirements in 40 CFR part 707, subpart D.

II. Background

A. What action is the agency taking?

    EPA is finalizing an amendment to the SNUR for the chemical 
substance identified as ethaneperoxoic acid, 1,1-dimethylpropyl ester, 
(PMN P-85-680), codified at 40 CFR 721.3020. This final action requires 
persons who intend to manufacture 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 January 28, 
2013 (78 FR 5761) (FRL-9370-5). EPA received no public comments in 
response to the proposal. Therefore, the Agency is issuing a final 
SNUR, as proposed that:
    1. Removes the significant new use requirements for protective 
equipment, hazard communication, and specific uses identified in the 
consent order.
    2. Modifies significant new use requirements for environmental 
releases by removing notification requirements for disposal and adding 
notification requirements for water releases above 61 parts per billion 
(ppb).
    3. Revises the recordkeeping requirements to reflect the modified 
SNUR requirements.

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 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 or process the 
chemical substance for that use. Persons who must report are described 
in Sec.  721.5.

III. Rationale for the Rule

    During review of PMN P-85-680, the chemical substance identified as 
ethaneperoxoic acid, 1,1-dimethylpropyl ester, 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 January 28, 
2013 (78 FR 5761) (``proposed amended rule''), and in the original 
final rule Federal Register document of June 26, 1990 (55 FR 26102). 
Based on these findings, a TSCA section 5(e) consent order requiring 
the use of hazard communication and appropriate exposure, use, and 
disposal 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 Sec.  721.160, and codified at Sec.  
721.1560 and redesignated as Sec.  721.3020.
    After the review of new test data subsequent to issuance of the 
TSCA section 5(e) consent order for P-85-680 and associated SNUR (see 
Unit II. of the proposed amended rule), and consideration of the 
factors included in TSCA section 5(a)(2) (see Unit IV.), EPA determined 
that the chemical substance meets one or more of the concern criteria 
in Sec.  721.170(b), but that these criteria are no longer met for the 
personal protective equipment, hazard communication, and specific use 
notification requirements. Consequently, EPA is proposing this 
modification to the SNUR at Sec.  721.3020 according to procedures in 
Sec. Sec.  721.160 and 721.185.

[[Page 46285]]

IV. Significant New Use Determination

    Section 5(a)(2) of TSCA states that EPA's determination that a use 
of a chemical substance is a significant new use must be made after 
consideration of 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.
     The reasonably anticipated manner and methods of 
manufacturing, processing, distribution in commerce, and disposal of a 
chemical substance.
    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 as ethaneperoxoic acid, 1,1-dimethylpropyl ester, 
(PMN P-85-680), 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.

V. Applicability of the Significant New Use Designation

    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) for a more 
detailed discussion of the cutoff date for ongoing uses.
    Any person who began commercial manufacture or processing of the 
chemical substance identified as ethaneperoxoic acid, 1,1-
dimethylpropyl ester, (PMN P-85-680), for any of the significant new 
uses designated in the proposed SNUR modification 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 Sec.  [emsp14]721.45(h), the person would be 
considered to have met the requirements of the final SNUR for those 
activities.

VI. Test Data and Other Information

    EPA recognizes that TSCA section 5 does not require the development 
of any particular test data before submission of a SNUN. There are two 
exceptions:
    1. Development of test data is required where the chemical 
substance subject to the SNUR is also subject to a test rule under TSCA 
section 4 (see TSCA section 5(b)(1)).
    2. Development of test data may be necessary where the chemical 
substance has been listed under TSCA section 5(b)(4) (see TSCA section 
5(b)(2)).
    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 Sec.  
720.50). However, upon review of PMNs and SNUNs, the Agency has the 
authority to require appropriate testing. In this case, EPA recommends 
persons, before performing any testing, to consult with the Agency 
pertaining to protocol selection.
    The recommended testing specified in Unit II.A. of the proposed 
rule may not be the only means of addressing the potential risks of the 
chemical substance. However, SNUNs submitted without any test data may 
increase the likelihood that EPA will take action under TSCA section 
5(e), particularly if satisfactory test results have not been obtained 
from a prior PMN or SNUN submitter. EPA recommends that potential SNUN 
submitters contact EPA early enough so that they will be able to 
conduct the appropriate tests.
    SNUN submitters should be aware that EPA will be better able to 
evaluate SNUNs which provide detailed information on the following:
     Human exposure and environmental release that may result 
from the significant new use of the chemical substances.
     Potential benefits of the chemical substances.
     Information on risks posed by the chemical substances 
compared to risks posed by potential substitutes.

VII. SNUN Submissions

    According to Sec.  721.1(c), persons submitting a SNUN must comply 
with the same notice requirements and EPA regulatory procedures as 
persons submitting a PMN, including submission of test data on health 
and environmental effects as described in Sec.  720.50. SNUNs must be 
on EPA Form No. 7710-25, generated using e-PMN software, and submitted 
to the Agency in accordance with the procedures set forth in Sec. Sec.  
721.25 and 720.40. E-PMN software is available electronically at https://www.epa.gov/opptintr/newchems.

VIII. Economic Analysis

    EPA evaluated the potential costs of establishing SNUN requirements 
for potential manufacturers 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-2012-0864.

IX. Statutory and Executive Order Reviews

A. Executive Order 12866

    This action modifies a SNUR for a chemical substance that is the 
subject of a PMN and 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).

B. Paperwork Reduction Act

    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. EPA has amended the table 
in 40 CFR part 9 to list the OMB approval number for the information 
collection requirements contained in this rule. This listing of the OMB 
control numbers and their subsequent codification in the CFR satisfies 
the display requirements of PRA and OMB's implementing regulations at 5 
CFR part 1320.
    The information collection requirements related to this action have 
already been approved by OMB pursuant to PRA under OMB control number 
2070-0012 (EPA ICR No. 574). This action does not impose any burden 
requiring additional OMB approval. If an entity were to submit a SNUN 
to the Agency, the annual burden is estimated

[[Page 46286]]

to average between 30 and 170 hours per response. This burden estimate 
includes the time needed to review instructions, search existing data 
sources, gather and maintain the data needed, and complete, review, and 
submit the required SNUN.
    Send any comments about the accuracy of the burden estimate, and 
any suggested methods for minimizing respondent burden, including 
through the use of automated collection techniques, to the Director, 
Collection Strategies Division, Office of Environmental Information 
(2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001. Please remember to include the OMB control 
number in any correspondence, but do not submit any completed forms to 
this address.

C. Regulatory Flexibility Act

    On February 18, 2012, EPA certified pursuant to section 605(b) of 
the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), that 
promulgation of a SNUR does not have a significant economic impact on a 
substantial number of small entities where the following are true:
    1. A significant number of SNUNs would not be submitted by small 
entities in response to the SNUR.
    2. The SNUN submitted by any small entity would not cost 
significantly more than $8,300.
    A copy of that certification is available in the docket for this 
rule.
    This rule is within the scope of the February 18, 2012 
certification. Based on the Economic Analysis discussed in Unit VIII. 
and EPA's experience promulgating SNURs (discussed in the 
certification), EPA believes that the following are true:
     A significant number of SNUNs would not be submitted by 
small entities in response to the SNUR.
     Submission of the SNUN would not cost any small entity 
significantly more than $8,300. Therefore, the promulgation of the SNUR 
would not have a significant economic impact on a substantial number of 
small entities.

D. Unfunded Mandates Reform Act

    Based on EPA's experience with proposing and finalizing SNURs, 
State, local, and Tribal governments have not been impacted by these 
rulemakings, and EPA does not have any reasons to believe that any 
State, local, or Tribal government will be impacted by this final rule. 
As such, EPA has determined that this final rule does not impose any 
enforceable duty, contain any unfunded mandate, or otherwise have any 
affect on small governments subject to the requirements of sections 
202, 203, 204, or 205 of the Unfunded Mandates Reform Act of 1995 
(UMRA) (Pub. L. 104-4).

E. Executive Order 13132

    This action will not have a substantial direct effect on States, on 
the relationship between the national government and the States, or on 
the distribution of power and responsibilities among the various levels 
of government, as specified in Executive Order 13132, entitled 
Federalism (64 FR 43255, August 10, 1999).

F. Executive Order 13175

    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 With 
Indian Tribal Governments (65 FR 67249, November 9, 2000), do not apply 
to this final rule.

G. Executive Order 13045

    This action is not subject to Executive Order 13045, entitled 
Protection of Children From Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997), because this is not an economically 
significant regulatory action as defined by Executive Order 12866, and 
this action does not address environmental health or safety risks 
disproportionately affecting children.

H. Executive Order 13211

    This action is not subject to Executive Order 13211, entitled 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001), because this action 
is not expected to affect energy supply, distribution, or use and 
because this action is not a significant regulatory action under 
Executive Order 12866.

I. National Technology Transfer and Advancement Act

    In addition, since this action does not involve any technical 
standards, section 12(d) of the National Technology Transfer and 
Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 
U.S.C. 272 note), does not apply to this action.

J. Executive Order 12898

    This action does not entail special considerations of environmental 
justice related issues as delineated by Executive Order 12898, entitled 
Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

X. Congressional Review Act (CRA)

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 721

    Environmental protection, Chemicals, Hazardous substances, 
Reporting and recordkeeping requirements.

    Dated: July 16, 2013.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and 
Toxics.
    Therefore, 40 CFR part 721 is amended as follows:

PART 721--[AMENDED]

0
1. The authority citation for part 721 continues to read as follows:

    Authority:  15 U.S.C. 2604, 2607, and 2625(c).

0
2. Amend Sec.  721.3020 as follows:
0
a. Revise the section heading.
0
b. Revise paragraphs (a)(1) and (a)(2)(i).
0
c. Remove and reserve paragraph (a)(2)(ii) and remove paragraphs 
(a)(2)(iii) and (iv).
0
d. Revise paragraph (b)(1).
0
e. Remove paragraph (b)(3).
    The revisions read as follows:


Sec.  721.3020  Ethaneperoxoic acid, 1,1-dimethylpropyl ester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as ethaneperoxoic 
acid, 1,1-dimethylpropyl ester (PMN P-85-680; CAS No. 690-83-5) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) * * *
    (i) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (N=61).
    (ii) [Reserved]
    (b) * * *
    (1) Recordkeeping. Recordkeeping requirements as specified in

[[Page 46287]]

Sec.  721.125(a), (b), (c), and (k) are applicable to manufacturers and 
processors of this substance.
* * * * *
[FR Doc. 2013-18180 Filed 7-30-13; 8:45 am]
BILLING CODE 6560-50-P