Proposed Significant New Use Rule for Phenol, 2,4-dimethyl-6-(1-methylpentadecyl)-, 81437-81441 [2011-33256]

Download as PDF Federal Register / Vol. 76, No. 249 / Wednesday, December 28, 2011 / Proposed Rules Board of Patent Appeals and Interferences was filed under 35 U.S.C. 134 and § 41.31 of this title and ending on the date an appeal brief in compliance with 41.37 or a request for continued examination in compliance with § 1.114 was filed; * * * * * Dated: December 15, 2011. David J. Kappos, Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office. [FR Doc. 2011–33150 Filed 12–27–11; 8:45 am] BILLING CODE 3510–16–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 721 [EPA–HQ–OPPT–2011–0633; FRL–9325–9] RIN 2070–AB27 Proposed Significant New Use Rule for Phenol, 2,4-dimethyl-6-(1methylpentadecyl)Environmental Protection Agency (EPA). ACTION: Proposed rule. AGENCY: EPA is proposing a significant new use rule (SNUR) under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for the chemical substance identified as phenol, 2,4-dimethyl-6-(1methylpentadecyl)- (PMN P–94–209; CAS No. 134701–20–5). This action would require persons who intend to manufacture, import, or process the substance 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. DATES: Comments must be received on or before January 27, 2012. ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA–HQ–OPPT–2011–0633, by one of the following methods: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the online instructions for submitting comments. • Mail: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460– 0001. • Hand Delivery: OPPT Document Control Office (DCO), EPA East Bldg., mstockstill on DSK4VPTVN1PROD with PROPOSALS SUMMARY: VerDate Mar<15>2010 17:25 Dec 27, 2011 Jkt 226001 Rm. 6428, 1201 Constitution Ave. NW., Washington, DC. Attention: Docket ID Number EPA–HQ–OPPT–2011–0633. The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the DCO is (202) 564–8930. Such deliveries are only accepted during the DCO’s normal hours of operation, and special arrangements should be made for deliveries of boxed information. Instructions: Direct your comments to docket ID number EPA–HQ–OPPT– 2011–0633. EPA’s policy is that all comments received will be included in the docket without change and may be made available online at http:// 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 regulations.gov or email. The 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 regulations.gov, your email address will be automatically captured and included as part of the comment that is placed in the 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. Docket: 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., 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 electronically 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 PO 00000 Frm 00037 Fmt 4702 Sfmt 4702 81437 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. FOR FURTHER INFORMATION CONTACT: For technical information contact: Abeer Hashem, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (202) 564–1117; email address: hashem.abeer@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. General Information A. Does this action apply to me? You may be potentially affected by this action if you manufacture, import, process, or use the chemical substance contained in this proposed rule. Potentially affected entities may include, but are not limited to: • Manufacturers, importers, 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 § 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 E:\FR\FM\28DEP1.SGM 28DEP1 81438 Federal Register / Vol. 76, No. 249 / Wednesday, December 28, 2011 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS 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 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. B. What should I consider as I prepare my comments for EPA? 1. Submitting CBI. Do not submit this information to EPA through 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: i. Identify the document by docket ID number and other identifying information (subject heading, Federal Register date and page number). ii. 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. iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes. iv. Describe any assumptions and provide any technical information and/ or data that you used. v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced. vi. Provide specific examples to illustrate your concerns and suggest alternatives. VerDate Mar<15>2010 17:25 Dec 27, 2011 Jkt 226001 vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats. viii. Make sure to submit your comments by the comment period deadline identified. II. Background A. What action is the agency taking? Under section 5(a)(2) of TSCA, EPA is re-proposing a SNUR previously proposed for phenol, 2,4-dimethyl-6-(1methylpentadecyl)- (PMN P–94–209; CAS No. 134701–20–5) in the Federal Register of September 9, 1998 (63 FR 48157) (FRL–6020–8) but which was not finalized. In the 1998 proposed SNUR, based on submitted test data, EPA expressed concerns for liver toxicity, kidney toxicity, adrenal toxicity, and blood toxicity. Additionally, based on submitted test data and analogy to phenols, EPA was also concerned that toxicity to aquatic organisms would occur at concentrations as low as 1 part per billion (ppb). EPA determined that use of the substance as described in the Premanufacture Notice (PMN) did not present an unreasonable risk because workers would not be subject to significant dermal exposures and there were no significant environmental releases. EPA also determined that other potential uses of the substance may result in significant dermal exposures to workers and significant environmental releases. Based on this information, the PMN substance met the concern criteria at § 721.170 (b)(3)(i) and (b)(4)(i). In the 1998 proposed SNUR, EPA proposed worker protection requirements as specified in § 721.63 (a)(2)(i) and (a)(3), release to water restrictions as specified in § 721.90 (a)(1), (b)(1), and (c)(1) and associated recordkeeping requirements. Recently, EPA re-evaluated the information now available on phenol, 2,4-dimethyl-6-(1-methylpentadecyl)-. Since the PMN was initially reviewed, the Agency’s Ecological Structure Activity Relationships (EcoSAR) dataset for phenols has been significantly updated to include 203 chemicals, up from 78 chemicals. The additional number of data points has increased the robustness of the category, which has changed the underlying Quantitative Structure Activity Relationships (QSAR). As a result, when the most recent version of EcoSAR was run for phenol, 2,4-dimethyl-6-(1methylpentadecyl)- in 2011, the program predicted no adverse ecotoxicological effects at saturation for this substance. Additionally, measured water solubility data submitted to the Agency subsequent to the 1998 proposal support the new EcoSAR prediction of PO 00000 Frm 00038 Fmt 4702 Sfmt 4702 no expected acute or chronic adverse ecological effects. Therefore, based upon the new EcoSAR predictions and the measured water solubility data, EPA now concludes that the ecological hazard and risk of this substance are low. EPA no longer determines that this substance may present an unreasonable risk to the aquatic environment. As a result EPA, based on the new data received and the Agency’s predictive tools, no longer finds that the PMN substance meets the concern criteria at § 721.170 (b)(4)(i). Therefore, EPA is re-proposing this SNUR, retaining the previously proposed worker protection requirements specified in § 721.63 (a)(2)(i) and (a)(3), while removing the proposed release to water restrictions specified § 721.90 (a)(1), (b)(1), and (c)(1). This proposed SNUR would require persons to notify EPA at least 90 days before commencing the manufacture, import, or processing of the chemical substance identified as phenol, 2,4dimethyl-6-(1-methyl pentadecyl)-, (PMN P–94–209; CAS No.134701–20–5), for any activity preliminarily designated by this proposed SNUR as a significant new use. Receipt of such notices allows EPA to assess risks that may be presented by the intended uses and, if appropriate, to regulate the proposed use before it occurs. The record established for this proposed SNUR is available in the docket under Docket ID number EPA–HQ–OPPT–2011–0633. 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, import, or process the chemical substance for that use. Persons who must report are described in § 721.5. C. Applicability of General Provisions 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, and applicability of the rule to uses occurring before the effective date of the rule. Provisions relating to user fees appear at 40 CFR part 700. According to E:\FR\FM\28DEP1.SGM 28DEP1 Federal Register / Vol. 76, No. 249 / Wednesday, December 28, 2011 / Proposed Rules § 721.1(c), persons subject to these SNURs must comply with the same notice 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 section 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. III. Significant New Use Determination mstockstill on DSK4VPTVN1PROD with PROPOSALS 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 authorized EPA to consider any other relevant factors. To determine what would constitute a significant new use for the chemical substance that is the subject of this proposed SNUR, 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. IV. Substance Subject to This Proposed Rule EPA is proposing to establish significant new use and recordkeeping requirements for the chemical substance identified as phenol, 2,4-dimethyl-6-(1methylpentadecyl)- (P–94–209). In this unit, EPA provides the following information for this chemical substance: VerDate Mar<15>2010 17:25 Dec 27, 2011 Jkt 226001 PMN Number P–94–209 Chemical name: Phenol 2,4-dimethyl6-(1-methylpentadecyl)-. Chemical Abstracts Service (CAS) number: 134701–20–5. Basis for action: The PMN states that the substance will be used as an antioxidant. EPA is not aware of additional uses of this PMN chemical substance. Based on submitted test data, there is concern for liver toxicity, kidney toxicity, adrenal toxicity, and blood toxicity. However, after review of the PMN EPA determined that use of the substance as described in the PMN did not present an unreasonable risk because workers would not be subject to significant dermal exposures. EPA has determined that other potential uses of the substance may result in significant dermal exposures to workers. Based on this information the PMN substance meets the concern criteria at § 721.170(b)(3)(i). Recommended testing: EPA has determined that a dermal absorption study (OPPTS Test Guideline 870.3250) would help characterize the health effects of the PMN substance. Test reports should include protocols approved by the EPA, certificate of analysis for the test substance, raw data, and results. CFR citation: 40 CFR 721.5725. V. Rationale and Objectives of the Proposed Rule A. Rationale During review of phenol, 2,4dimethyl-6-(1-methylpentadecyl)-, EPA preliminarily determined that one or more of the criteria of concern established at § 721.170 were met, as discussed in Units II and IV. B. Objectives EPA is proposing this SNUR for a chemical substance that has undergone premanufacture review because the Agency wants to achieve the following objectives with regard to the significant new uses designated in this proposed rule: • EPA would receive notice of any person’s intent to manufacture, import, or process a listed chemical substance for the described significant new use before that activity begins. • EPA would have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing, importing, or processing a listed chemical substance for the described significant new use. • EPA would be able to regulate prospective manufacturers, importers, or processors of a listed chemical substance before the described PO 00000 Frm 00039 Fmt 4702 Sfmt 4702 81439 significant new use of that chemical substance occurs, provided that regulation is warranted pursuant to TSCA sections 5(e), 5(f), 6, or 7. Issuance of a SNUR for a chemical substance does not signify that the chemical substance is listed on the TSCA Inventory. Guidance on how to determine if a chemical substance is on the TSCA Inventory is available on the Internet at http://www.epa.gov/opptintr/ existingchemicals/pubs/tscainventory/ index.html. VI. Notice and Comment Procedures EPA is issuing this SNUR by notice and comment procedure, as described in § 721.170(d)(4). In accordance with § 721.170(d)(4)(ii)(A), persons are given the opportunity to submit comments on or before January 27, 2012 on whether EPA should establish notification requirements. VII. Applicability of the Proposed Rule to Uses Occurring Before Effective Date of the Final Rule To establish a significant ‘‘new’’ use, EPA must determine that the use is not ongoing. EPA solicits comments on whether any of the uses proposed as significant new uses are ongoing. As discussed in the Federal Register 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 rule rather than as of the effective date of the final rule. If uses begun after publication of the proposed rule 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 significant new use before the rule became final, and then argue that the use was ongoing before the effective date of the final rule. Thus, persons who begin commercial manufacture, import, or processing activities with the chemical substances that would be regulated as a ‘‘significant new use’’ through this proposed rule, must cease any such activity before the effective date of the rule if and when finalized. To resume their activities, these persons would have to comply with all applicable SNUR notice requirements and wait until the notice review period, including all extensions, expires. EPA has promulgated provisions to allow persons to comply with this proposed SNUR before the effective date. If a person were to meet the conditions of advance compliance under § 721.45(h), the person would be E:\FR\FM\28DEP1.SGM 28DEP1 81440 Federal Register / Vol. 76, No. 249 / Wednesday, December 28, 2011 / Proposed Rules mstockstill on DSK4VPTVN1PROD with PROPOSALS considered exempt from the requirements of the SNUR. VIII. Test Data and Other Information EPA recognizes that TSCA section 5 does not require developing any particular test data before submission of a SNUN. The two exceptions are: 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. EPA recommended certain testing in Unit IV. 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. To access the OPPTS Test Guidelines referenced in this document electronically, please go to http:// www.epa.gov/ocspp and select ‘‘Test Methods and Guidelines.’’ The recommended tests may not be the only means of addressing the potential risks of the chemical substance. However, submitting a SNUN 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. IX. SNUN Submissions According to § 721.1(c), persons submitting a SNUN must comply with the same notice requirements and EPA VerDate Mar<15>2010 17:25 Dec 27, 2011 Jkt 226001 regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in § 720.50. SNUNs must be submitted on EPA Form No. 7710–25 in accordance with the procedures set forth in §§ 721.25 and 720.40. E–PMN software is available electronically at http:// www.epa.gov/opptintr/newchems. X. Economic Analysis EPA has evaluated the potential costs of establishing SNUN requirements for potential manufacturers, importers, and processors of the chemical substances subject to this proposed rule. EPA’s complete economic analysis is available in the docket under docket ID number EPA–HQ–OPPT–2011–0633. XI. Statutory and Executive Order Reviews A. Executive Order 12866 This proposed rule would establish a SNUR for a chemical substance that was the subject of a PMN. 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 would amend the table in 40 CFR part 9 to list the OMB approval number for the information collection requirements contained in this proposed rule, if the SNUR is subsequently issued as a final 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. This Information Collection Request (ICR) was previously subject to public notice and comment prior to OMB approval, and given the technical nature of the table, EPA finds that further notice and comment to amend it is unnecessary. As a result, EPA finds that there is ‘‘good cause’’ under section 553(b)(3)(B) of the Administrative Procedure Act, 5 U.S.C. PO 00000 Frm 00040 Fmt 4702 Sfmt 4702 553(b)(3)(B), to amend this table without further notice and comment. 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 would not impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated 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 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 SNUR would 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 over 1,000 SNURs, the Agency receives on average only 5 notices per year. Of those SNUNs submitted from 2006–2008, only one appears to be from a small entity. In addition, the estimated reporting cost for submission of a SNUN (see Unit IX.) is minimal regardless of the size of the firm. Therefore, EPA E:\FR\FM\28DEP1.SGM 28DEP1 Federal Register / Vol. 76, No. 249 / Wednesday, December 28, 2011 / Proposed Rules believes that the potential economic impacts of complying with this SNUR are not expected to be significant or adversely impact a substantial number of small entities. In a SNUR that published in the Federal Register 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. 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 would be impacted by this proposed rule. As such, EPA has determined that this proposed rule would not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect 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). mstockstill on DSK4VPTVN1PROD with PROPOSALS E. Executive Order 13132 This action would 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 proposed rule would not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This proposed rule would not significantly nor uniquely affect the communities of Indian Tribal governments, nor would 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 proposed 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 VerDate Mar<15>2010 17:25 Dec 27, 2011 Jkt 226001 12866, and this action does not address environmental health or safety risks disproportionately affecting children. H. Executive Order 13211 This proposed rule 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 81441 (i) Protection in the workplace. Requirements as specified in § 721.63 (a)(2)(i) and (a)(3). (ii) [Reserved] (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), (d), and (e) are applicable to manufacturers, importers, and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section. [FR Doc. 2011–33256 Filed 12–27–11; 8:45 am] 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. BILLING CODE 6560–50–P J. Executive Order 12898 [EPA–HQ–OPPT–2010–1075; FRL–9329–4] 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). RIN 2070–AB27 List of Subjects in 40 CFR Part 721 Environmental protection, Chemicals, Hazardous substances, Reporting and recordkeeping requirements. Dated: December 16, 2011. Wendy C. Hamnett, Director, Office of Pollution Prevention and Toxics. Therefore, it is proposed that 40 CFR part 721 be amended as follows: PART 721—[AMENDED] 1. The authority citation for part 721 continues to read as follows: Authority: 15 U.S.C. 2604, 2607, and 2625(c). 2. Add § 721.5725 to subpart E to read as follows: § 721.5725 Phenol, 2,4-dimethyl-6-(1methylpentadecyl)-. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as phenol, 2,4-dimethyl-6-(1methylpentadecyl)- (PMN P–94–209; CAS No. 134701–20–5) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: PO 00000 Frm 00041 Fmt 4702 Sfmt 4702 ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 721 Proposed Significant New Use Rules on Certain Chemical Substances Environmental Protection Agency (EPA). ACTION: Proposed rule. AGENCY: EPA is proposing significant new use rules (SNURs) under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for the chemical substances rutile, tin zinc, calcium-doped (CAS No. 389623–01–2) and rutile, tin zinc, sodium-doped (CAS No. 389623–07–8) which were the subject of premanufacture notices (PMNs P–06–36 and P–06–37) and TSCA section 5(e) consent orders issued by EPA. The proposed SNURs on these substances, which are based on and consistent with the provisions of the underlying consent orders, would designate as a significant new use the absence of the protective measures required in the consent orders. This action would require persons who intend to manufacture, import, or process either of the 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 the activity before it occurs. DATES: Comments must be received on or before January 27, 2012. ADDRESSES: Submit your comments, identified by docket identification (ID) SUMMARY: E:\FR\FM\28DEP1.SGM 28DEP1

Agencies

[Federal Register Volume 76, Number 249 (Wednesday, December 28, 2011)]
[Proposed Rules]
[Pages 81437-81441]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-33256]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2011-0633; FRL-9325-9]
RIN 2070-AB27


Proposed Significant New Use Rule for Phenol, 2,4-dimethyl-6-(1-
methylpentadecyl)-

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing a significant new use rule (SNUR) under 
section 5(a)(2) of the Toxic Substances Control Act (TSCA) for the 
chemical substance identified as phenol, 2,4-dimethyl-6-(1-
methylpentadecyl)- (PMN P-94-209; CAS No. 134701-20-5). This action 
would require persons who intend to manufacture, import, or process the 
substance 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.

DATES: Comments must be received on or before January 27, 2012.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2011-0633, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments.
     Mail: Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001.
     Hand Delivery: OPPT Document Control Office (DCO), EPA 
East Bldg., Rm. 6428, 1201 Constitution Ave. NW., Washington, DC. 
Attention: Docket ID Number EPA-HQ-OPPT-2011-0633. The DCO is open from 
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the DCO is (202) 564-8930. Such deliveries are 
only accepted during the DCO's normal hours of operation, and special 
arrangements should be made for deliveries of boxed information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2011-0633. EPA's policy is that all comments received will be included 
in the docket without change and may be made available online at http://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 regulations.gov or email. The 
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 regulations.gov, your email 
address will be automatically captured and included as part of the 
comment that is placed in the 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.
    Docket: 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., 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 
electronically 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.

FOR FURTHER INFORMATION CONTACT: For technical information contact: 
Abeer Hashem, Chemical Control Division (7405M), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: 
(202) 564-1117; email address: hashem.abeer@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. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture, 
import, process, or use the chemical substance contained in this 
proposed rule. Potentially affected entities may include, but are not 
limited to:
     Manufacturers, importers, 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

[[Page 81438]]

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 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.  [emsp14]721.20), and must 
comply with the export notification requirements in 40 CFR part 707, 
subpart D.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
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:
    i. Identify the document by docket ID number and other identifying 
information (subject heading, Federal Register date and page number).
    ii. 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.
    iii. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information 
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you 
arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
    vi. Provide specific examples to illustrate your concerns and 
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of 
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period 
deadline identified.

II. Background

A. What action is the agency taking?

    Under section 5(a)(2) of TSCA, EPA is re-proposing a SNUR 
previously proposed for phenol, 2,4-dimethyl-6-(1-methylpentadecyl)- 
(PMN P-94-209; CAS No. 134701-20-5) in the Federal Register of 
September 9, 1998 (63 FR 48157) (FRL-6020-8) but which was not 
finalized. In the 1998 proposed SNUR, based on submitted test data, EPA 
expressed concerns for liver toxicity, kidney toxicity, adrenal 
toxicity, and blood toxicity. Additionally, based on submitted test 
data and analogy to phenols, EPA was also concerned that toxicity to 
aquatic organisms would occur at concentrations as low as 1 part per 
billion (ppb). EPA determined that use of the substance as described in 
the Premanufacture Notice (PMN) did not present an unreasonable risk 
because workers would not be subject to significant dermal exposures 
and there were no significant environmental releases. EPA also 
determined that other potential uses of the substance may result in 
significant dermal exposures to workers and significant environmental 
releases. Based on this information, the PMN substance met the concern 
criteria at Sec.  721.170 (b)(3)(i) and (b)(4)(i). In the 1998 proposed 
SNUR, EPA proposed worker protection requirements as specified in Sec.  
721.63 (a)(2)(i) and (a)(3), release to water restrictions as specified 
in Sec.  721.90 (a)(1), (b)(1), and (c)(1) and associated recordkeeping 
requirements.
    Recently, EPA re-evaluated the information now available on phenol, 
2,4-dimethyl-6-(1-methylpentadecyl)-. Since the PMN was initially 
reviewed, the Agency's Ecological Structure Activity Relationships 
(EcoSAR) dataset for phenols has been significantly updated to include 
203 chemicals, up from 78 chemicals. The additional number of data 
points has increased the robustness of the category, which has changed 
the underlying Quantitative Structure Activity Relationships (QSAR). As 
a result, when the most recent version of EcoSAR was run for phenol, 
2,4-dimethyl-6-(1-methylpentadecyl)- in 2011, the program predicted no 
adverse ecotoxicological effects at saturation for this substance. 
Additionally, measured water solubility data submitted to the Agency 
subsequent to the 1998 proposal support the new EcoSAR prediction of no 
expected acute or chronic adverse ecological effects.
    Therefore, based upon the new EcoSAR predictions and the measured 
water solubility data, EPA now concludes that the ecological hazard and 
risk of this substance are low. EPA no longer determines that this 
substance may present an unreasonable risk to the aquatic environment. 
As a result EPA, based on the new data received and the Agency's 
predictive tools, no longer finds that the PMN substance meets the 
concern criteria at Sec.  721.170 (b)(4)(i). Therefore, EPA is re-
proposing this SNUR, retaining the previously proposed worker 
protection requirements specified in Sec.  721.63 (a)(2)(i) and (a)(3), 
while removing the proposed release to water restrictions specified 
Sec.  721.90 (a)(1), (b)(1), and (c)(1).
    This proposed SNUR would require persons to notify EPA at least 90 
days before commencing the manufacture, import, or processing of the 
chemical substance identified as phenol, 2,4-dimethyl-6-(1-methyl 
pentadecyl)-, (PMN P-94-209; CAS No.134701-20-5), for any activity 
preliminarily designated by this proposed SNUR as a significant new 
use. Receipt of such notices allows EPA to assess risks that may be 
presented by the intended uses and, if appropriate, to regulate the 
proposed use before it occurs. The record established for this proposed 
SNUR is available in the docket under Docket ID number EPA-HQ-OPPT-
2011-0633.

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

C. Applicability of General Provisions

    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, and applicability 
of the rule to uses occurring before the effective date of the rule. 
Provisions relating to user fees appear at 40 CFR part 700. According 
to

[[Page 81439]]

Sec.  [emsp14]721.1(c), persons subject to these SNURs must comply with 
the same notice 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 section 
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.

III. 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 authorized EPA to consider any other relevant factors.
    To determine what would constitute a significant new use for the 
chemical substance that is the subject of this proposed SNUR, 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.

IV. Substance Subject to This Proposed Rule

    EPA is proposing to establish significant new use and recordkeeping 
requirements for the chemical substance identified as phenol, 2,4-
dimethyl-6-(1-methylpentadecyl)- (P-94-209). In this unit, EPA provides 
the following information for this chemical substance:

PMN Number P-94-209

    Chemical name: Phenol 2,4-dimethyl-6-(1-methylpentadecyl)-.
    Chemical Abstracts Service (CAS) number: 134701-20-5.
    Basis for action: The PMN states that the substance will be used as 
an antioxidant. EPA is not aware of additional uses of this PMN 
chemical substance. Based on submitted test data, there is concern for 
liver toxicity, kidney toxicity, adrenal toxicity, and blood toxicity. 
However, after review of the PMN EPA determined that use of the 
substance as described in the PMN did not present an unreasonable risk 
because workers would not be subject to significant dermal exposures. 
EPA has determined that other potential uses of the substance may 
result in significant dermal exposures to workers. Based on this 
information the PMN substance meets the concern criteria at Sec.  
721.170(b)(3)(i).
    Recommended testing: EPA has determined that a dermal absorption 
study (OPPTS Test Guideline 870.3250) would help characterize the 
health effects of the PMN substance. Test reports should include 
protocols approved by the EPA, certificate of analysis for the test 
substance, raw data, and results.
    CFR citation: 40 CFR 721.5725.

V. Rationale and Objectives of the Proposed Rule

A. Rationale

    During review of phenol, 2,4-dimethyl-6-(1-methylpentadecyl)-, EPA 
preliminarily determined that one or more of the criteria of concern 
established at Sec.  [emsp14]721.170 were met, as discussed in Units II 
and IV.

B. Objectives

    EPA is proposing this SNUR for a chemical substance that has 
undergone premanufacture review because the Agency wants to achieve the 
following objectives with regard to the significant new uses designated 
in this proposed rule:
     EPA would receive notice of any person's intent to 
manufacture, import, or process a listed chemical substance for the 
described significant new use before that activity begins.
     EPA would have an opportunity to review and evaluate data 
submitted in a SNUN before the notice submitter begins manufacturing, 
importing, or processing a listed chemical substance for the described 
significant new use.
     EPA would be able to regulate prospective manufacturers, 
importers, or processors of a listed chemical substance before the 
described significant new use of that chemical substance occurs, 
provided that regulation is warranted pursuant to TSCA sections 5(e), 
5(f), 6, or 7.
    Issuance of a SNUR for a chemical substance does not signify that 
the chemical substance is listed on the TSCA Inventory. Guidance on how 
to determine if a chemical substance is on the TSCA Inventory is 
available on the Internet at http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.

VI. Notice and Comment Procedures

    EPA is issuing this SNUR by notice and comment procedure, as 
described in Sec.  [emsp14]721.170(d)(4). In accordance with Sec.  
[emsp14]721.170(d)(4)(ii)(A), persons are given the opportunity to 
submit comments on or before January 27, 2012 on whether EPA should 
establish notification requirements.

VII. Applicability of the Proposed Rule to Uses Occurring Before 
Effective Date of the Final Rule

    To establish a significant ``new'' use, EPA must determine that the 
use is not ongoing. EPA solicits comments on whether any of the uses 
proposed as significant new uses are ongoing.
    As discussed in the Federal Register 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 rule rather than as of the 
effective date of the final rule. If uses begun after publication of 
the proposed rule 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 significant new use 
before the rule became final, and then argue that the use was ongoing 
before the effective date of the final rule. Thus, persons who begin 
commercial manufacture, import, or processing activities with the 
chemical substances that would be regulated as a ``significant new 
use'' through this proposed rule, must cease any such activity before 
the effective date of the rule if and when finalized. To resume their 
activities, these persons would have to comply with all applicable SNUR 
notice requirements and wait until the notice review period, including 
all extensions, expires.
    EPA has promulgated provisions to allow persons to comply with this 
proposed SNUR before the effective date. If a person were to meet the 
conditions of advance compliance under Sec.  721.45(h), the person 
would be

[[Page 81440]]

considered exempt from the requirements of the SNUR.

VIII. Test Data and Other Information

    EPA recognizes that TSCA section 5 does not require developing any 
particular test data before submission of a SNUN. The two exceptions 
are:
    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. EPA recommended certain 
testing in Unit IV. 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. To access the OPPTS Test Guidelines referenced in 
this document electronically, please go to http://www.epa.gov/ocspp and 
select ``Test Methods and Guidelines.''
    The recommended tests may not be the only means of addressing the 
potential risks of the chemical substance. However, submitting a SNUN 
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.

IX. SNUN Submissions

    According to Sec.  [emsp14]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 submitted on EPA Form No. 7710-25 in accordance with the 
procedures set forth in Sec. Sec.  721.25 and 720.40. E-PMN software is 
available electronically at http://www.epa.gov/opptintr/newchems.

X. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN 
requirements for potential manufacturers, importers, and processors of 
the chemical substances subject to this proposed rule. EPA's complete 
economic analysis is available in the docket under docket ID number 
EPA-HQ-OPPT-2011-0633.

XI. Statutory and Executive Order Reviews

A. Executive Order 12866

    This proposed rule would establish a SNUR for a chemical substance 
that was the subject of a PMN. 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 would amend the table 
in 40 CFR part 9 to list the OMB approval number for the information 
collection requirements contained in this proposed rule, if the SNUR is 
subsequently issued as a final 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. This Information Collection Request (ICR) was previously 
subject to public notice and comment prior to OMB approval, and given 
the technical nature of the table, EPA finds that further notice and 
comment to amend it is unnecessary. As a result, EPA finds that there 
is ``good cause'' under section 553(b)(3)(B) of the Administrative 
Procedure Act, 5 U.S.C. 553(b)(3)(B), to amend this table without 
further notice and comment.
    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 would not impose any burden 
requiring additional OMB approval. If an entity were to submit a SNUN 
to the Agency, the annual burden is estimated 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

    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 SNUR would 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 over 1,000 SNURs, the 
Agency receives on average only 5 notices per year. Of those SNUNs 
submitted from 2006-2008, only one appears to be from a small entity. 
In addition, the estimated reporting cost for submission of a SNUN (see 
Unit IX.) is minimal regardless of the size of the firm. Therefore, EPA

[[Page 81441]]

believes that the potential economic impacts of complying with this 
SNUR are not expected to be significant or adversely impact a 
substantial number of small entities. In a SNUR that published in the 
Federal Register 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.

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 would be impacted by this proposed 
rule. As such, EPA has determined that this proposed rule would not 
impose any enforceable duty, contain any unfunded mandate, or otherwise 
have any effect 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 would 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 proposed rule would not have Tribal implications because it is 
not expected to have substantial direct effects on Indian Tribes. This 
proposed rule would not significantly nor uniquely affect the 
communities of Indian Tribal governments, nor would 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 proposed 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 proposed rule 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).

List of Subjects in 40 CFR Part 721

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

    Dated: December 16, 2011.
Wendy C. Hamnett,
Director, Office of Pollution Prevention and Toxics.
    Therefore, it is proposed that 40 CFR part 721 be amended as 
follows:

PART 721--[AMENDED]

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

    Authority: 15 U.S.C. 2604, 2607, and 2625(c).
    2. Add Sec.  721.5725 to subpart E to read as follows:


Sec.  721.5725  Phenol, 2,4-dimethyl-6-(1-methylpentadecyl)-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as phenol, 2,4-
dimethyl-6-(1-methylpentadecyl)- (PMN P-94-209; CAS No. 134701-20-5) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63 (a)(2)(i) and (a)(3).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (d), and (e) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
[FR Doc. 2011-33256 Filed 12-27-11; 8:45 am]
BILLING CODE 6560-50-P