Significant New Use Rules on Certain Chemical Substances, 20296-20308 [2012-8092]

Download as PDF 20296 Federal Register / Vol. 77, No. 65 / Wednesday, April 4, 2012 / Rules and Regulations restricted area as the Supervisor of Shipbuilding, Conversion, and Repair Gulf Coast (SUPSHIP Gulf Coast). After the document was published, the Department of the Navy revised the mission, functions, and tasks of the Supervisors of Shipbuilding, Conversion and Repair organization. This organizational revision changed the administrative and enforcement responsibilities for the subject restricted area from SUPSHIP Gulf Coast to SUPSHIP Bath, Maine. This document corrects the final rule by revising § 334.815 (b) and (c) to reflect the organizational change. DATES: Effective date: April 4, 2012. Mr. David Olson, Headquarters, Operations and Regulatory Community of Practice, Washington, DC at 202–761–4922 or by email at david.b.olson@usace.army.mil or Mr. Todd Vesperman, U.S. Army Corps of Engineers, St. Paul District, Regulatory Branch, at 920–448–2824 or by email at todd.m.vesperman@ usace.army.mil. FOR FURTHER INFORMATION CONTACT: The U.S. Army Corps of Engineers published a final rule in the Federal Register on May 24, 2011 (76 FR 30024), and later determined that correcting amendments need to be made to address encroachment into a Federal navigation channel and a change in the enforcing authority that occurred as a result of the Department of the Navy revising the mission, functions, and tasks of the Supervisors of Shipbuilding, Conversion and Repair (SUPSHIPs) organization. That organizational revision changed administrative and enforcement responsibilities for the subject restricted area from SUPSHIP Gulf Coast to SUPSHIP Bath, Maine. This correcting amendment changes the latitude and longitude coordinates in § 334.815(a) so that the restricted area will not encroach into the Federal navigation project. This correcting amendment also changes the administrative and enforcement responsibilities in § 334.815(b) and (c) for the subject restricted area from SUPSHIP Gulf Coast to SUPSHIP Bath, Maine. SUPPLEMENTARY INFORMATION: emcdonald on DSK29S0YB1PROD with RULES List of Subjects in 33 CFR Part 334 Danger zones, Marine safety, Navigation (water), Restricted areas, Waterways. For the reasons stated in the preamble, 33 CFR part 334 is corrected by making the following correcting amendments: VerDate Mar<15>2010 14:04 Apr 03, 2012 Jkt 226001 PART 334—DANGER ZONE AND RESTRICTED AREA REGULATIONS ENVIRONMENTAL PROTECTION AGENCY 1. The authority citation for 33 CFR part 334 continues to read as follows: 40 CFR Parts 9 and 721 Authority: 40 Stat. 266 (33 U.S.C. 1) and 40 Stat. 892 (33 U.S.C. 3). RIN 2070–AB27 ■ ■ 2. Revise § 334.815 to read as follows: [EPA–HQ–OPPT–2011–0942; FRL–9333–3] Significant New Use Rules on Certain Chemical Substances Environmental Protection Agency (EPA). ACTION: Direct final rule. § 334.815 Menominee River, at the Marinette Marine Corporation Shipyard, Marinette, Wisconsin; Naval Restricted Area. AGENCY: (a) The area. The waters adjacent to Marinette Marine Corporation’s pier defined by a rectangular shaped area on the south side of the river beginning on shore at the eastern property line of Marinette Marine Corporation at latitude 45°5′58.7″ N, longitude 087°36′55.9″ W; thence northerly to latitude 45°5′59.2″ N, longitude 087°36′55.8″ W; thence westerly to latitude 45°5′59.6″ N, longitude 087°36′57.5″ W; thence westerly to latitude 45°6′00.0″ N, longitude 087°36′58.7″ W; thence westerly to latitude 45°6′1.7″ N, longitude 087°37′4.9″ W; thence westerly to latitude 45°6′2.8″ N, longitude 087°37′9.8″ W; thence southerly to latitude 45°6′2.2″ N, longitude 087°37′10.0″ W; thence easterly along the Marinette Marine Corporation pier to the point of origin. The restricted area will be marked by a lighted and signed floating buoy line. (b) The regulation. All persons, swimmers, vessels and other craft, except those vessels under the supervision or contract to a local military or Naval authority, vessels of the United States Coast Guard, and local or state law enforcement vessels, are prohibited from entering the restricted area when marked by a signed floating buoy line without permission from the Supervisor of Shipbuilding, Conversion and Repair, United States Navy, Bath, Maine or his/her authorized representative. (c) Enforcement. The regulation in this section shall be enforced by the Supervisor of Shipbuilding, Conversion and Repair, United States Navy, Bath, Maine and/or such agencies or persons as he/she may designate. EPA is promulgating significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for 17 chemical substances which were the subject of premanufacture notices (PMNs). Two of these chemical substances are subject to TSCA consent orders issued by EPA. This action requires persons who intend to manufacture, import, or process any of these 17 chemical substances for an activity that is designated as a significant new use by this rule to notify EPA at least 90 days before commencing that activity. The required notification will provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. DATES: This rule is effective on June 4, 2012. For purposes of judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on April 18, 2012. Written adverse or critical comments, or notice of intent to submit adverse or critical comments, on one or more of these SNURs must be received on or before May 4, 2012 (see Unit VI. of the SUPPLEMENTARY INFORMATION). For additional information on related reporting requirement dates, see Units I.A., VI., and VII. of the SUPPLEMENTARY INFORMATION. ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA–HQ–OPPT–2011–0942, by one of the following methods: • Federal eRulemaking Portal: https:// 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, Rm. 6428, 1201 Constitution Ave. NW., Washington, DC. Attention: Docket ID Number EPA–HQ–OPPT–2011–0942. 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 Dated: March 29, 2012. Richard C. Lockwood, Chief, Operations and Regulatory, Directorate of Civil Works. [FR Doc. 2012–8120 Filed 4–3–12; 8:45 am] BILLING CODE 3720–58–P PO 00000 Frm 00016 Fmt 4700 Sfmt 4700 SUMMARY: E:\FR\FM\04APR1.SGM 04APR1 emcdonald on DSK29S0YB1PROD with RULES Federal Register / Vol. 77, No. 65 / Wednesday, April 4, 2012 / Rules and Regulations 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– 2011–0942. EPA’s policy is that all comments received will be included in the 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 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 https://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 https://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, VerDate Mar<15>2010 14:04 Apr 03, 2012 Jkt 226001 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: Kenneth Moss, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001; telephone number: (202) 564–9232; email address: moss.kenneth@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 substances contained in this rule. Potentially affected entities may include, but are not limited to: • Manufacturers, importers, or processors of one or more subject chemical substances (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 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 PO 00000 Frm 00017 Fmt 4700 Sfmt 4700 20297 of chemicals subject to these SNURs 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 this rule 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. 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. E:\FR\FM\04APR1.SGM 04APR1 20298 Federal Register / Vol. 77, No. 65 / Wednesday, April 4, 2012 / Rules and Regulations II. Background A. What action is the agency taking? EPA is promulgating these SNURs using direct final procedures. These SNURs will require persons to notify EPA at least 90 days before commencing the manufacture, import, or processing of a chemical substance for any activity designated by these SNURs 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. Additional rationale and background to these rules are more fully set out in the preamble to EPA’s first direct final SNUR published in the Federal Register issue of April 24, 1990 (55 FR 17376) (April 24, 1990 SNUR). Consult that preamble for further information on the objectives, rationale, and procedures for SNURs and on the basis for significant new use designations, including provisions for developing test data. emcdonald on DSK29S0YB1PROD with RULES 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 III. 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 § 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 sections 5(h)(1), 5(h)(2), 5(h)(3), and 5(h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, VerDate Mar<15>2010 14:04 Apr 03, 2012 Jkt 226001 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 17 chemical substances that are the subject of these SNURs, EPA considered relevant information about the toxicity of the chemical substances, likely human exposures and environmental releases associated with possible uses, and the four bulleted TSCA section 5(a)(2) factors listed in this unit. IV. Substances Subject to This Rule EPA is establishing significant new use and recordkeeping requirements for 17 chemical substances in 40 CFR part 721, subpart E. In this unit, EPA provides the following information for each chemical substance: • PMN number. • Chemical name (generic name, if the specific name is claimed as CBI). • Chemical Abstracts Service (CAS) number (if assigned for non-confidential chemical identities). • Basis for the TSCA section 5(e) consent order or, for non-section 5(e) SNURs (i.e., SNURs without TSCA section 5(e) consent orders), the basis for the SNUR. • Toxicity concerns. • Tests recommended by EPA to provide sufficient information to evaluate the chemical substance (see Unit VIII. for more information). • CFR citation assigned in the regulatory text section of this rule. PO 00000 Frm 00018 Fmt 4700 Sfmt 4700 The regulatory text section of this rule specifies the activities designated as significant new uses. Certain new uses, including production volume limits (i.e., limits on manufacture and importation volume) and other uses designated in this rule, may be claimed as CBI. Unit IX. discusses a procedure companies may use to ascertain whether a proposed use constitutes a significant new use. This rule includes two PMN substances (P–10–486 and P–10–487) that are subject to ‘‘risk-based’’ consent orders under TSCA section 5(e)(1)(A)(ii)(I) in which EPA determined that activities associated with the PMN substances may present unreasonable risk to human health or the environment. Those consent orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The socalled ‘‘5(e) SNURs’’ on these PMN substances are promulgated pursuant to § 721.160, and are based on and consistent with the provisions in the underlying consent orders. The 5(e) SNURs designate as a ‘‘significant new use’’ the absence of the protective measures required in the corresponding consent orders. This rule also includes SNURs on 15 PMN substances (P–09–248, P–11–33, P–11–34, P–11–188, P–11–316, P–11– 333, P–11–424, P–11–511, P–11–546, P– 11–578, P–11–580, P–11–591, P–11– 608, P–11–637, and P–11–662) that are not subject to consent orders under TSCA section 5(e). In these cases, for a variety of reasons, EPA did not find that the use scenario described in the PMN triggered the determinations set forth under TSCA section 5(e). However, EPA does believe that certain changes from the use scenario described in the PMN could result in increased exposures, thereby constituting a ‘‘significant new use.’’ These so-called ‘‘non-5(e) SNURs’’ are promulgated pursuant to § 721.170. EPA has determined that every activity designated as a ‘‘significant new use’’ in all non-5(e) SNURs issued under § 721.170 satisfies the two requirements stipulated in § 721.170(c)(2), i.e., these significant new use activities, ‘‘(i) are different from those described in the premanufacture notice for the substance, including any amendments, deletions, and additions of activities to the premanufacture notice, and (ii) may be accompanied by changes in exposure or release levels that are significant in relation to the health or environmental concerns identified’’ for the PMN substance. E:\FR\FM\04APR1.SGM 04APR1 Federal Register / Vol. 77, No. 65 / Wednesday, April 4, 2012 / Rules and Regulations PMN Number P–09–248 Chemical name: Ethyleneamine polyphosphates (generic). CAS number: Not available. Basis for action: The PMN states that the use of the substance will be as a flame retardant added to polymers. Based on test data on the PMN substance, EPA predicts toxicity to aquatic organisms may occur if releases of the PMN substance to surface water from uses other than described in the PMN exceed the releases expected from the use described in the PMN. For the described use in the PMN, significant environmental releases are not expected. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance other than as described in the PMN may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(i). Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400) and a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would help characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.10282. emcdonald on DSK29S0YB1PROD with RULES PMN Numbers P–10–486 and P–10–487 Chemical names: (P–10–486) Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-sulfo-.omega.-hydroxy-, C12–13branched and linear alkyl ethers, sodium salts and (P–10–487) Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-sulfo-.omega.-hydroxy-, C14–15branched and linear alkyl ethers, sodium salts. CAS numbers: (P–10–486) 958238– 81–8 and (P–10–487) 958238–82–9. Effective date of TSCA section 5(e) consent order: July 22, 2011. Basis for TSCA section 5(e) consent order: The PMNs state that the use of the substances will be for downhole injection for enhanced oil recovery. The order was issued under TSCA sections 5(e)(1)(A)(i), (e)(1)(A)(ii)(I), and (e)(1)(A)(ii)(II) based on a finding that these substances may present an unreasonable risk of injury to the environment and will be produced in substantial quantities and may reasonably be anticipated to enter the environment in substantial quantities. To protect against the risk, the order requires certain hazard communication requirements, specific disposal requirements for processing and use, VerDate Mar<15>2010 14:04 Apr 03, 2012 Jkt 226001 and prohibits releases from manufacture of the PMN substances resulting in surface water concentrations exceeding 28 parts per billion (ppb) for P–10–486 and 4 ppb for P–10–487. The SNUR designates as a ‘‘significant new use’’ the absence of these protective measures. Toxicity concern: Based on ecological structure activity relationship (EcoSAR) analysis of test data on analogous anionic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 28 ppb for P–10–486 and 4 ppb for P–10–487 in surface waters. Recommended testing: EPA has determined that the results of a fish acute toxicity test (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) on P–10–487 would help characterize the environmental effects of the PMN substances. The PMN submitter agreed not to exceed the production volume limit in the consent order before conducting these tests. CFR citations: 40 CFR 721.10283 (P– 10–486) and 40 CFR 721.10284 (P–10– 487). PMN Number P–11–33 Chemical name: Formaldehyde, polymer with 4-(1,1dimethylethyl)phenol, reaction products with 1-piperazineethanamine. CAS number: 1191244–16–2. Basis for action: The PMN states that the PMN substance will be used as a hardener for epoxy resin laminating systems. Based on ecological structure activity relationship (EcoSAR) analysis of test data on analogous aliphatic amines and phenol-amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 17 ppb of the PMN substance in surface waters. As described in the PMN, the substance is not released to surface waters. Therefore, EPA has not determined that the proposed manufacture, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 17 ppb may cause significant adverse environmental effects. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(4)(ii). Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater (OPPTS Test Guideline 850.1075); an aquatic PO 00000 Frm 00019 Fmt 4700 Sfmt 4700 20299 invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.10285. PMN Number P–11–34 Chemical name: Formaldehyde, polymer with .alpha.-(2aminomethylethyl)-.omega.-(2aminomethylethoxy)poly[oxy(methyl1,2-ethanediyl)] and 4-(1,1dimethylethyl)phenol. CAS number: 1192146–78–3. Basis for action: The PMN states that the PMN substance will be used as a hardener for epoxy resin laminating systems. Based on EcoSAR analysis of test data on analogous aliphatic amines and phenol-amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 21 ppb of the PMN substance in surface waters. As described in the PMNs, the substances are not released to surface waters. Therefore, EPA has not determined that the proposed manufacture, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 21 ppb may cause significant adverse environmental effects. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(4)(ii). Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.10286. PMN Number P–11–188 Chemical name: Infused carbon nanostructures (generic). CAS number: Not available. Basis for action: The PMN states that the generic (non-confidential) use of the substance is as an additive to provide conductive properties to reinforcements used in composites. Based on available information on analogous chemical substances, the PMN substance may cause lung effects. For the use described in the PMN, no significant inhalation exposures are expected. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable E:\FR\FM\04APR1.SGM 04APR1 20300 Federal Register / Vol. 77, No. 65 / Wednesday, April 4, 2012 / Rules and Regulations emcdonald on DSK29S0YB1PROD with RULES risk. EPA has determined, however, that a manufacturing process other than as described in the PMN (the manufacturing process described in the PMN includes incorporation of the PMN substance into pellets) may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii). Recommended testing: EPA has determined that the results of the following information would help characterize the health effects of the PMN substance: The dimensions, characteristics, and physical-chemical properties of the carbon nanostructures. These properties should be determined once a year for three consecutive years. CFR citation: 40 CFR 721.10287. PMN Number P–11–316 Chemical name: Cyclohexane, oxidized, by-products from, distn. residues. CAS number: 1014979–92–0. Basis for action: The PMN states that the generic (non-confidential) uses of the substance are as an industrial solvent in closed and open systems, and as an accelerant in permitted industrial explosives. Based on EcoSAR analysis of test data on analogous esters, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 4 ppb of the PMN substance in surface waters. As described in the PMN, the substance is not released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 4 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii). Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, fresh water daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.10288. PMN Number P–11–333 Chemical name: Hexanedioic acid polymer with aliphatic polyol dihydrogen phosphate aromatic ester (generic). CAS number: Not available. VerDate Mar<15>2010 14:04 Apr 03, 2012 Jkt 226001 Basis for action: The PMN states that the generic (non-confidential) use will be as a component of industrial coatings. Based on EcoSAR analysis of test data on analogous organic phosphates, EPA predicts toxicity to aquatic organisms may occur if releases of the PMN substance to surface water from uses other than described in the PMN exceed the releases expected from the use described in the PMN. For the described use in the PMN, significant environmental releases are not expected. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance other than as described in the PMN may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii). Recommended testing: EPA has determined that the results of a ready biodegradability test (OPPTS Test Guideline 835.3110); a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.10289. PMN Number P–11–424 Chemical name: Alkenoyloxy arylphenone (generic). CAS number: Not available. Basis for action: The PMN states that the generic (non-confidential) use of the substance is as a monomer for polymer applications. Based on test data on the PMN substance, and EcoSAR analysis of test data on analogous methacrylates, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 26 ppb of the PMN substance in surface waters. As described in the PMN, releases to surface waters are not expected to exceed 26 ppb. Therefore, EPA has not determined that the proposed manufacture, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 26 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(i) and (b)(4)(ii). Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test PO 00000 Frm 00020 Fmt 4700 Sfmt 4700 Guideline 850.1400) and a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would help characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.10290. PMN Number P–11–511 Chemical name: C15 olefins (generic). CAS number: Not available. Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a petroleum substitute base. Based on EcoSAR analysis of test data on analogous neutral organics, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substance in surface waters. As described in the PMN, the substance is not released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 1 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii). Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.10291. PMN Number P–11–546 Chemical name: Silicate (2-), hexafluoro-, cesium (1:2). CAS number: 16923–87–8. Basis for action: The PMN states that the PMN substance will be used as a brazing (metal joining) agent. Based on submitted test data for an analogous PMN substance, EPA identified concerns for degeneration of the kidneys, necrosis of the heart muscle, and effects on the male reproductive organs to workers from inhalation exposure to the PMN substance. For the uses described in the PMN, significant dermal or inhalation exposure is not expected. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, use of the substance other than as a brazing (metal joining) agent may cause serious health effects. Based on this information, the PMN substance meets E:\FR\FM\04APR1.SGM 04APR1 Federal Register / Vol. 77, No. 65 / Wednesday, April 4, 2012 / Rules and Regulations the concern criteria at § 721.170(b)(3)(ii). Recommended testing: EPA has determined that the results of a repeated dose 28-day oral toxicity test (OPPTS Test Guideline 870.3050) in rodents would help characterize the human health effects of the PMN substance. CFR citation: 40 CFR 721.10292. emcdonald on DSK29S0YB1PROD with RULES PMN Number P–11–578 Chemical name: Benzoic acid, 4-(1,1dimethylethyl)-, hydrazide. CAS number: 43100–38–5. Basis for action: The PMN states that the use of this substance will be as an intermediate. Based on SAR analysis of test data on analogous hydrazines, EPA identified concerns for mutagenicity, oncogenicity, developmental toxicity, dermal sensitization, and respiratory sensitization from exposure to the PMN substance via the inhalation route. In addition, based on EcoSAR analysis of analogous hydrazines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 2 ppb of the PMN substance in surface waters. For the intermediate use described in the PMN, inhalation exposures and environmental releases to surface waters are not expected. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance other than as an intermediate, or any use resulting in surface water concentrations exceeding 2 ppb may cause serious health effects and significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(1)(i)(C), (b)(3)(ii), and (b)(4)(ii). Recommended testing: EPA has determined that the results of a 90-day oral toxicity test in rodents (OPPTS Test Guideline 870.3100) by the inhalation route; a carcinogenicity test (OPPTS Test Guideline 870.4200) by the inhalation route, in two species of rodents; a fish acute toxicity test (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the human health and environmental effects of the PMN substance. CFR citation: 40 CFR 721.10293. PMN Number P–11–580 Chemical name: Cyclohexanol, 2,6bis(1,1-dimethylethyl)-4-methyl-. CAS number: 163119–16–2. VerDate Mar<15>2010 14:04 Apr 03, 2012 Jkt 226001 Basis for action: The PMN states that the use of this substance will be as an intermediate. Based on EcoSAR analysis of test data on analogous neutral organics, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 2 ppb of the PMN substance in surface waters. As described in the PMN, releases to surface waters are not expected. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use resulting in surface water concentrations exceeding 2 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii). Recommended testing: EPA has determined that the results of a fish acute toxicity test (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.10294. PMN Number P–11–591 Chemical name: IPDI modified isophthalic acid, neopentyl glycol and adipic acid (generic). CAS numbers: Not available. Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a lamination adhesive. Based on test data on analogous substances, EPA identified concerns for oncogenicity, if the PMN substance is inhaled, as well as concerns for irritation to the eyes, skin, mucous membranes, and dermal and respiratory sensitization to workers from dermal and inhalation exposure to the PMN. For the industrial uses described in the PMN, and due to the use of personal protective equipment, significant worker exposure is unlikely, as dermal or inhalation exposure is not expected. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of this substance may present an unreasonable risk. EPA has determined, however, that substantial production volume increases, or use of the substance in consumer products may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(1)(i)(C) and (b)(3)(ii). Recommended testing: EPA has determined that the results of a dermal PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 20301 sensitization test (OPPTS Test Guideline 870.2600) and a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465) would help characterize the human health effects of the PMN substance. CFR citation: 40 CFR 721.10295. PMN Number P–11–608 Chemical name: 1,3-Benzenediol, 4[1-[[3-(1H-imidazol-1yl)propyl]imino]ethyl]-. CAS number: 1313999–39–1. Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an epoxy catalyst. Based on EcoSAR analysis of test data on polycationic polymers, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substance in surface waters. As described in the PMN, the substance is not released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 1 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii). Recommended testing: EPA has determined that the results of a fish acute toxicity test (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance. Additionally, EPA recommends that OPPTS Test Guideline 850.1000, ‘‘Special Considerations for Conducting Aquatic Laboratory Studies’’ be consulted for materials, such as this PMN substance, that are water insoluble or of low water solubility. CFR citation: 40 CFR 721.10296. PMN Number P–11–637 Chemical name: Tin, C16-18 and C18unsatd. fatty acids castor-oil fatty acids complexes. CAS number: 1315588–63–6. Basis for action: The PMN states that the use of the substance will be as a polyurethane foam catalyst. Based on test data on the PMN substance, EPA identified concerns for dermal sensitization and blood and liver toxicity to workers from exposure to the PMN substance. For the industrial use described in the PMN, and due to the use of personal protective equipment, E:\FR\FM\04APR1.SGM 04APR1 20302 Federal Register / Vol. 77, No. 65 / Wednesday, April 4, 2012 / Rules and Regulations significant worker exposure is unlikely, as dermal or inhalation exposure is not expected. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of this substance may present an unreasonable risk. EPA has determined, however, that domestic manufacture of the substance or use of the substance in consumer products may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(i). Recommended testing: EPA has determined that the results of a 28-day dermal toxicity study (OPPTS Test Guideline 870.3200) would help characterize the human health effects of the PMN substance. CFR citation: 40 CFR 721.10297. PMN Number P–11–662 emcdonald on DSK29S0YB1PROD with RULES Chemical name: MDI terminated polyester polyurethane polymer (generic). CAS number: Not available. Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a liquid moisture cure adhesive. Based on test data on analogous diisocyanates, EPA identified concerns for mutagenicity, irritation to lungs and mucous membranes, and dermal and respiratory sensitization to workers from dermal and inhalation exposure to the PMN substance. For the industrial uses described in the PMN, and due to the use of personal protective equipment, significant worker exposure is unlikely, as dermal or inhalation exposure is not expected. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substance in consumer products may cause serious health effects. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(3)(ii). Recommended testing: EPA has determined that the results of a dermal sensitization test (OPPTS Test Guideline 870.2600) and a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465) would help characterize the human health effects of the PMN substance. CFR citation: 40 CFR 721.10298. V. Rationale and Objectives of the Rule A. Rationale During review of the PMNs submitted for the chemical substances that are subject to these SNURs, EPA concluded that for two of the 17 chemical substances, regulation was warranted VerDate Mar<15>2010 14:04 Apr 03, 2012 Jkt 226001 under TSCA section 5(e), pending the development of information sufficient to make reasoned evaluations of the health or environmental effects of the chemical substances. The basis for such findings is outlined in Unit IV. Based on these findings, TSCA section 5(e) consent orders requiring the use of appropriate exposure controls were negotiated with the PMN submitters. The SNUR provisions for these chemical substances are consistent with the provisions of the TSCA section 5(e) consent orders. These SNURs are promulgated pursuant to § 721.160 (see Unit II.). In the other 15 cases, where the uses are not regulated under a TSCA section 5(e) consent order, EPA determined that one or more of the criteria of concern established at § 721.170 were met, as discussed in Unit IV. B. Objectives EPA is issuing these SNURs for specific chemical substances which have undergone premanufacture review because the Agency wants to achieve the following objectives with regard to the significant new uses designated in this rule: • EPA will 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 will 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 will 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. • EPA will ensure that all manufacturers, importers, and processors of the same chemical substance that is subject to a TSCA section 5(e) consent order are subject to similar requirements. 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 https://www.epa.gov/opptintr/ existingchemicals/pubs/tscainventory/ index.html. VI. Direct Final Procedures EPA is issuing these SNURs as a direct final rule, as described in PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 § 721.160(c)(3) and § 721.170(d)(4). In accordance with § 721.160(c)(3)(ii) and § 721.170(d)(4)(i)(B), the effective date of this rule is June 4, 2012 without further notice, unless EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments before May 4, 2012. If EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments, on one or more of these SNURs before May 4, 2012, EPA will withdraw the relevant sections of this direct final rule before its effective date. EPA will then issue a proposed SNUR for the chemical substance(s) on which adverse or critical comments were received, providing a 30-day period for public comment. This rule establishes SNURs for a number of chemical substances. Any person who submits adverse or critical comments, or notice of intent to submit adverse or critical comments, must identify the chemical substance and the new use to which it applies. EPA will not withdraw a SNUR for a chemical substance not identified in the comment. VII. Applicability of Rule to Uses Occurring Before Effective Date of the Rule Significant new use designations for a chemical substance are legally established as of the date of publication of this direct final rule, April 4, 2012. To establish a significant ‘‘new’’ use, EPA must determine that the use is not ongoing. The chemical substances subject to this rule have undergone premanufacture review. TSCA section 5(e) consent orders have been issued for two chemical substances and the PMN submitters are prohibited by the TSCA section 5(e) consent orders from undertaking activities which EPA is designating as significant new uses. In cases where EPA has not received a notice of commencement (NOC) and the chemical substance has not been added to the TSCA Inventory, no other person may commence such activities without first submitting a PMN. For chemical substances for which an NOC has not been submitted at this time, EPA concludes that the uses are not ongoing. However, EPA recognizes that prior to the effective date of the rule, when chemical substances identified in this SNUR are added to the TSCA Inventory, other persons may engage in a significant new use as defined in this rule before the effective date of the rule. However, 7 of the 17 chemical substances contained in this rule have CBI chemical identities, and since EPA has received a limited number of post- E:\FR\FM\04APR1.SGM 04APR1 Federal Register / Vol. 77, No. 65 / Wednesday, April 4, 2012 / Rules and Regulations emcdonald on DSK29S0YB1PROD with RULES PMN bona fide submissions (per §§ 720.25 and 721.11), the Agency believes that it is highly unlikely that any of the significant new uses described in the regulatory text of this rule are ongoing. As discussed in the April 24, 1990 SNUR, 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 this direct final rule rather than as of the effective date of the rule. If uses begun after publication were considered ongoing rather than new, it would be difficult for EPA to establish SNUR notice requirements because a person could defeat the SNUR by initiating the significant new use before the rule became effective, and then argue that the use was ongoing before the effective date of the rule. Thus, persons who begin commercial manufacture, import, or processing of the chemical substances regulated through this SNUR will have to cease any such activity before the effective date of this rule. 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 SNUR before the effective date. If a person meets the conditions of advance compliance under § 721.45(h), the person is 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. In cases where EPA issued a TSCA section 5(e) consent order that requires or recommends certain testing, Unit IV. lists those tests. Unit IV. also lists recommended testing for non-5(e) VerDate Mar<15>2010 14:04 Apr 03, 2012 Jkt 226001 SNURs. Descriptions of tests are provided for informational purposes. EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol selection. To access the harmonized test guidelines referenced in this document electronically, please go to https:// www.epa.gov/ocspp and select ‘‘Test Methods and Guidelines.’’ In the TSCA section 5(e) consent orders for two of the chemical substances regulated under this rule, EPA has established production volume limits in view of the lack of data on the potential health and environmental risks that may be posed by the significant new uses or increased exposure to the chemical substances. These limits cannot be exceeded unless the PMN submitter first submits the results of toxicity tests that would permit a reasoned evaluation of the potential risks posed by these chemical substances. Under recent TSCA section 5(e) consent orders, each PMN submitter is required to submit each study at least 14 weeks (earlier TSCA section 5(e) consent orders required submissions at least 12 weeks) before reaching the specified production limit. Listings of the tests specified in the TSCA section 5(e) consent orders are included in Unit IV. The SNURs contain the same production volume limits as the TSCA section 5(e) consent orders. Exceeding these production limits is defined as a significant new use. Persons who intend to exceed the production limit must notify the Agency by submitting a SNUN at least 90 days in advance of commencement of non-exempt commercial manufacture, import, or processing. The recommended tests specified in Unit IV. 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. PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 20303 • Information on risks posed by the chemical substances compared to risks posed by potential substitutes. IX. Procedural Determinations By this rule, EPA is establishing certain significant new uses which have been claimed as CBI subject to Agency confidentiality regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a final determination or other disposition of the confidentiality claim under 40 CFR part 2 procedures, EPA is required to keep this information confidential. EPA promulgated a procedure to deal with the situation where a specific significant new use is CBI, at 40 CFR 721.1725(b)(1). Under these procedures a manufacturer, importer, or processor may request EPA to determine whether a proposed use would be a significant new use under the rule. The manufacturer, importer, or processor must show that it has a bona fide intent to manufacture, import, or process the chemical substance and must identify the specific use for which it intends to manufacture, import, or process the chemical substance. If EPA concludes that the person has shown a bona fide intent to manufacture, import, or process the chemical substance, EPA will tell the person whether the use identified in the bona fide submission would be a significant new use under the rule. Since most of the chemical identities of the chemical substances subject to these SNURs are also CBI, manufacturers, importers, and processors can combine the bona fide submission under the procedure in § 721.1725(b)(1) with that under § 721.11 into a single step. If EPA determines that the use identified in the bona fide submission would not be a significant new use, i.e., the use does not meet the criteria specified in the rule for a significant new use, that person can manufacture, import, or process the chemical substance so long as the significant new use trigger is not met. In the case of a production volume trigger, this means that the aggregate annual production volume does not exceed that identified in the bona fide submission to EPA. Because of confidentiality concerns, EPA does not typically disclose the actual production volume that constitutes the use trigger. Thus, if the person later intends to exceed that volume, a new bona fide submission would be necessary to determine whether that higher volume would be a significant new use. E:\FR\FM\04APR1.SGM 04APR1 20304 Federal Register / Vol. 77, No. 65 / Wednesday, April 4, 2012 / Rules and Regulations X. SNUN Submissions According to § 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 § 720.50. SNUNs must be submitted 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. XI. 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 rule. EPA’s complete economic analysis is available in the docket under docket ID number EPA– HQ–OPPT–2011–0942. XII. Statutory and Executive Order Reviews emcdonald on DSK29S0YB1PROD with RULES A. Executive Order 12866 This rule establishes SNURs for several new chemical substances that were the subject of PMNs, or TSCA section 5(e) consent orders. 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 is amending 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. This Information Collection Request (ICR) was previously subject to public notice and comment prior to OMB approval, and given the technical nature of the VerDate Mar<15>2010 14:04 Apr 03, 2012 Jkt 226001 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 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 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, and (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 XI and EPA’s experience promulgating SNURs (discussed in the certification), EPA believes that the following are true: (1) A significant number of SNUNs would not be submitted by small entities in response to the SNUR and (2) 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 PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 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 rule. As such, EPA has determined that this 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 rule does not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This 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 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, E:\FR\FM\04APR1.SGM 04APR1 Federal Register / Vol. 77, No. 65 / Wednesday, April 4, 2012 / Rules and Regulations 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). XIII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. 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 rule is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). List of Subjects 40 CFR Part 9 Environmental protection, Reporting and recordkeeping requirements. 242b, 243, 246, 300f, 300g, 300g–1, 300g–2, 300g–3, 300g–4, 300g–5, 300g–6, 300j–1, 300j–2, 300j–3, 300j–4, 300j–9, 1857 et seq., 6901–6992k, 7401–7671q, 7542, 9601–9657, 11023, 11048. 2. The table in § 9.1 is amended by adding the following sections in numerical order under the undesignated center heading ‘‘Significant New Uses of Chemical Substances’’ to read as follows: ■ § 9.1 OMB approvals under the Paperwork Reduction Act. * * * * * OMB control No. 40 CFR citation * * * * * Significant New Uses of Chemical Substances * * 721.10282 721.10283 721.10284 721.10285 721.10286 721.10287 721.10288 721.10289 721.10290 721.10291 721.10292 721.10293 721.10294 721.10295 721.10296 721.10297 721.10298 * * * ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. * * * * * * * 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 * * * 40 CFR Part 721 Environmental protection, Chemicals, Hazardous substances, Reporting and recordkeeping requirements. PART 721—[AMENDED] Dated: March 23, 2012. Maria J. Doa, Director, Chemical Control Division, Office of Pollution Prevention and Toxics. Authority: 15 U.S.C. 2604, 2607, and 2625(c). PART 9—[AMENDED] 1. The authority citation for part 9 continues to read as follows: emcdonald on DSK29S0YB1PROD with RULES ■ Authority: 7 U.S.C. 135 et seq., 136–136y; 15 U.S.C. 2001, 2003, 2005, 2006, 2601–2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330, 1342, 1344, 1345(d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 1971–1975 Comp. p. 973; 42 U.S.C. 241, 14:04 Apr 03, 2012 Jkt 226001 4. Add § 721.10282 to subpart E to read as follows: ■ Therefore, 40 CFR parts 9 and 721 are amended as follows: VerDate Mar<15>2010 3. The authority citation for part 721 continues to read as follows: ■ § 721.10282 Ethyleneamine polyphosphates (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as ethyleneamine polyphosphates (PMN P–09–248) 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 00025 Fmt 4700 Sfmt 4700 20305 (i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(j). (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), and (i) 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. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(i) of this section. ■ 5. Add § 721.10283 to subpart E to read as follows: § 721.10283 Poly[oxy(methyl-1,2ethanediyl)], .alpha.-sulfo-.omega.-hydroxy-, C12-13-branched and linear alkyl ethers, sodium salts. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as poly[oxy(methyl-1,2-ethanediyl)], .alpha.-sulfo-.omega.-hydroxy-, C12-13branched and linear alkyl ethers, sodium salts (PMN P–10–486; CAS No. 958238–81–8) 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) Hazard communication program. Requirements as specified in § 721.72(a), (b), (c), (d), (f), (g)(3)(i), (g)(3)(ii), (g)(4)(i), (g)(4)(ii), (g)(4)(iii), and (g)(5). (ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(p) (330,000 kilograms for this substance and P–10– 487 combined). (iii) Disposal. Requirements as specified in § 721.85(b)(1) and (c)(1) solvent rinsate resulting from cleaning of storage and holding tanks, shipboard tanks, iso containers, rail cars, and trucks used to transport the substance may only be disposed of by incineration. Sampling wastes containing the substance may only be disposed of by incineration, and § 721.85(c)(3) for oilfield applications, when the substance will no longer be injected into a well at a particular site for enhanced oil recovery, the water rinsate of the field holding tank and any remaining field water containing the substance must be injected into a designated disposal well, either a class E:\FR\FM\04APR1.SGM 04APR1 20306 Federal Register / Vol. 77, No. 65 / Wednesday, April 4, 2012 / Rules and Regulations (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), (f), (g), (h), (i), and (k) 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 significant new use rule. * * * * * ■ 7. Add § 721.10285 to subpart E to read as follows: § 721.10284 Poly[oxy(methyl-1,2ethanediyl)], .alpha.-sulfo-.omega.-hydroxy-, C14-15-branched and linear alkyl ethers, sodium salts. emcdonald on DSK29S0YB1PROD with RULES I hazardous waste disposal well or another class II well. (iv) Release to water. Requirements as specified in § 721.90(a)(4) (N = 28). (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), (f), (g), (h), (i), and (k) 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 significant new use rule. ■ 6. Add § 721.10284 to subpart E to read as follows: (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as formaldehyde, polymer with 4-(1,1dimethylethyl)phenol, reaction products with 1-piperazineethanamine (PMN P–11–33; CAS No. 1191244–16–2) 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) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) (N = 17 parts per billion (ppb)). (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), and (k) 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. ■ 8. Add § 721.10286 to subpart E to read as follows: (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as poly[oxy(methyl-1,2-ethanediyl)], .alpha.-sulfo-.omega.-hydroxy-, C14-15branched and linear alkyl ethers, sodium salts (PMN P–10–487; CAS No. 958238–82–9) 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) Hazard communication program. Requirements as specified in § 721.72(a), (b), (c), (d), (f), (g)(3)(i), (g)(3)(ii), (g)(4)(i), (g)(4)(ii), (g)(4)(iii), and (g)(5). (ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(p) (330,000 kilograms for this substance and for P–10–486 combined). (iii) Disposal. Requirements as specified in § 721.85(b)(1) and (c)(1) solvent rinsate resulting from cleaning of storage and holding tanks, shipboard tanks, iso containers, rail cars, and trucks used to transport the substance may only be disposed of by incineration. Sampling wastes containing the substance may only be disposed of by incineration, and § 721.85(c)(3) for oilfield applications, when the substance will no longer be injected into a well at a particular site for enhanced oil recovery, the water rinsate of the field holding tank and any remaining field water containing the substance must be injected into a designated disposal well, either a class I hazardous waste disposal well or another class II well. (iv) Release to water. Requirements as specified in § 721.90(a)(4) (N = 4). VerDate Mar<15>2010 14:04 Apr 03, 2012 Jkt 226001 § 721.10285 Formaldehyde, polymer with 4-(1,1-dimethylethyl)phenol, reaction products with 1-piperazineethanamine. § 721.10286 Formaldehyde, polymer with .alpha.-(2-aminomethylethyl)-.omega.-(2aminomethylethoxy)poly[oxy(methyl-1,2ethanediyl)] and 4-(1,1dimethylethyl)phenol. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as formaldehyde, polymer with .alpha.-(2aminomethylethyl)-.omega.-(2aminomethylethoxy)poly[oxy(methyl1,2-ethanediyl)] and 4-(1,1dimethylethyl)phenol) (PMN P–11–34; CAS No. 1192146–78–3) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. PO 00000 Frm 00026 Fmt 4700 Sfmt 4700 (2) The significant new uses are: (i) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) (N = 21 ppb). (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), and (k) 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. ■ 9. Add § 721.10287 to subpart E to read as follows: § 721.10287 Infused carbon nanostructures (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as infused carbon nanostructures (PMN P–11–188) 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) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(j) (manufacturing process described in the PMN; the process described in the PMN includes the incorporation of the PMN substance into pellets). (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) and (i) 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 significant new use rule. ■ 10. Add § 721.10288 to subpart E to read as follows: § 721.10288 Cyclohexane, oxidized, byproducts from, distn. residues. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as cyclohexane, oxidized, by-products from, distn. residues (PMN P–11–316; CAS No. 1014979–92–0) 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: E:\FR\FM\04APR1.SGM 04APR1 Federal Register / Vol. 77, No. 65 / Wednesday, April 4, 2012 / Rules and Regulations (i) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) (N = 4 ppb). (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), and (k) 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 significant new use rule. ■ 11. Add § 721.10289 to subpart E to read as follows: (i) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) (N = 26). (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), and (k) 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. ■ 13. Add § 721.10291 to subpart E to read as follows: § 721.10289 Hexanedioic acid polymer with aliphatic polyol dihydrogen phosphate aromatic ester (generic). § 721.10291 (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as hexanedioic acid polymer with aliphatic polyol dihydrogen phosphate aromatic ester (PMN P–11– 333) 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) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(j). (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), and (i) 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. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(i) of this section. ■ 12. Add § 721.10290 to subpart E to read as follows: emcdonald on DSK29S0YB1PROD with RULES § 721.10290 (generic). Alkenoyloxy arylphenone (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkenoyloxy arylphenone (PMN P–11–424) 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: VerDate Mar<15>2010 14:04 Apr 03, 2012 Jkt 226001 C15 olefins (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as C15 olefins (PMN P–11– 511) 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) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) (N = 1 ppb). (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), and (k) 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. ■ 14. Add § 721.10292 to subpart E to read as follows: § 721.10292 Silicate (2-), hexafluoro-, cesium (1:2). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as silicate (2-) hexafluoro-cesium (1:2) (PMN P–11–546; CAS No. 16923–87–8) 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) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(j) (use as brazing (metal joining) agent). (ii) [Reserved] (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. PO 00000 Frm 00027 Fmt 4700 Sfmt 4700 20307 (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a), (b), (c), and (i) 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. ■ 15. Add § 721.10293 to subpart E to read as follows: § 721.10293 Benzoic acid, 4-(1,1dimethylethyl)-, hydrazide. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as benzoic acid, 4-(1,1-dimethylethyl)-, hydrazide (PMN P–11–578; CAS No. 43100–38–5) 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) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(g). (ii) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) (N = 2 ppb). (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), (i), and (k) 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. ■ 16. Add § 721.10294 to subpart E to read as follows: § 721.10294 Cyclohexanol, 2,6-bis(1,1dimethylethyl)-4-methyl-. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as cyclohexanol, 2,6-bis(1,1dimethylethyl)-4-methyl- (PMN P–11– 580; CAS No. 163119–16–2) 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) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) (N = 2 ppb). (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), and (k) are E:\FR\FM\04APR1.SGM 04APR1 20308 Federal Register / Vol. 77, No. 65 / Wednesday, April 4, 2012 / Rules and Regulations 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. ■ 17. Add new § 721.10295 to subpart E to read as follows: § 721.10295 IPDI modified isophthalic acid, neopentyl glycol and adipic acid (generic). (a) Chemical substances and significant new uses subject to reporting. (1) The chemical substance identified generically as IPDI modified isophthalic acid, neopentyl glycol and adipic acid (PMN P–11–591) 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) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(o) and (s) (15,000 kilograms). (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), and (i) 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. ■ 18. Add new § 721.10296 to subpart E to read as follows: emcdonald on DSK29S0YB1PROD with RULES § 721.10296 1,3-Benzenediol, 4-[1-[[3-(lHimidazol-1-yl)propyl]imino] ethyl]-. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1,3-benzenediol, 4-[ 1-[[3-(lH-imidazol1-yl)propyl]imino[ethyl]- (PMN P–11– 608; CAS No. 1313999–39–1) 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) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) (N = 1 ppb). (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), and (k) are applicable to manufacturers, importers, and processors of this substance. (2) Limitations or revocation of certain notification requirements. The VerDate Mar<15>2010 14:04 Apr 03, 2012 Jkt 226001 provisions of § 721.185 apply to this section. ■ 19. Add new § 721.10297 to subpart E to read as follows: ENVIRONMENTAL PROTECTION AGENCY § 721.10297 Tin, C16-18 and C18-unsatd. fatty acids castor-oil fatty acids complexes. [EPA–R09–OAR–2011–0544; FRL–9633–3] (a) Chemical substances and significant new uses subject to reporting. (1) The chemical substance identified as tin, C16-18 and C18-unsatd. fatty acids castor-oil fatty acids complexes (PMN P–11–637; CAS No. 1315588–63–6) 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) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f) and (o). (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), and (i) 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. ■ 20. Add new § 721.10298 to subpart E to read as follows: § 721.10298 MDI terminated polyester polyurethane polymer (generic). (a) Chemical substances and significant new uses subject to reporting. (1) The chemical substance identified generically as MDI terminated polyester polyurethane polymer (P–11–662) 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) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(o). (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), and (i) 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. 2012–8092 Filed 4–3–12; 8:45 am] BILLING CODE 6560–50–P PO 00000 Frm 00028 Fmt 4700 Sfmt 4700 40 CFR Part 52 Approval and Promulgation of Implementations Plans; California Air Resources Board—In-Use Heavy-Duty Diesel-Fueled Truck and Bus Regulation, and Drayage Truck Regulation Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: EPA is taking final action to approve a revision to the California State Implementation Plan (SIP) submitted by the California Air Resources Board (CARB or Board). This revision concerns two regulations that reduce emissions of diesel particulate matter (PM), oxides of nitrogen (NOX), and other pollutants from in-use, heavyduty diesel-fueled trucks and buses, and drayage trucks. EPA is approving this SIP revision because the Agency has determined that the regulations are consistent with the relevant Clean Air Act requirements, policies and guidance. Final approval of the two regulations and incorporation of them into the California SIP makes them federally enforceable. DATES: Effective Date: This rule is effective on May 4, 2012. ADDRESSES: EPA has established docket number EPA–R09–OAR–2011–0544 for this action. The index to the docket is available electronically at www.regulations.gov and in hard copy at EPA Region IX, 75 Hawthorne Street, San Francisco, California. While all documents in the docket are listed in the index, some information may be publicly available only at the hard copy location (e.g., copyrighted material), and some may not be publicly available in either location (e.g., Confidential Business Information). To inspect the hard copy materials, please schedule an appointment during normal business hours with the contact listed in the FOR FURTHER INFORMATION CONTACT section. FOR FURTHER INFORMATION CONTACT: Roxanne Johnson, EPA Region IX, (415) 947–4150, johnson.roxanne@epa.gov. SUPPLEMENTARY INFORMATION: Throughout this document, ‘‘we,’’ ‘‘us’’ and ‘‘our’’ refer to EPA. SUMMARY: Table of Contents I. EPA’s Proposed Action II. Public Comments and EPA Responses III. Final Action IV. Statutory and Executive Order Reviews E:\FR\FM\04APR1.SGM 04APR1

Agencies

[Federal Register Volume 77, Number 65 (Wednesday, April 4, 2012)]
[Rules and Regulations]
[Pages 20296-20308]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-8092]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2011-0942; FRL-9333-3]
RIN 2070-AB27


Significant New Use Rules on Certain Chemical Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: EPA is promulgating significant new use rules (SNURs) under 
the Toxic Substances Control Act (TSCA) for 17 chemical substances 
which were the subject of premanufacture notices (PMNs). Two of these 
chemical substances are subject to TSCA consent orders issued by EPA. 
This action requires persons who intend to manufacture, import, or 
process any of these 17 chemical substances for an activity that is 
designated as a significant new use by this rule to notify EPA at least 
90 days before commencing that activity. The required notification will 
provide EPA with the opportunity to evaluate the intended use and, if 
necessary, to prohibit or limit that activity before it occurs.

DATES: This rule is effective on June 4, 2012. For purposes of judicial 
review, this rule shall be promulgated at 1 p.m. (e.s.t.) on April 18, 
2012.
    Written adverse or critical comments, or notice of intent to submit 
adverse or critical comments, on one or more of these SNURs must be 
received on or before May 4, 2012 (see Unit VI. of the SUPPLEMENTARY 
INFORMATION).
    For additional information on related reporting requirement dates, 
see Units I.A., VI., and VII. of the SUPPLEMENTARY INFORMATION.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2011-0942, by one of the following methods:
     Federal eRulemaking Portal: https://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, Rm. 6428, 1201 Constitution Ave. NW., Washington, DC. Attention: 
Docket ID Number EPA-HQ-OPPT-2011-0942. 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

[[Page 20297]]

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-
2011-0942. EPA's policy is that all comments received will be included 
in the 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 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 https://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 https://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: Kenneth Moss, Chemical Control 
Division (7405M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001; telephone number: (202) 564-9232; email 
address: moss.kenneth@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 substances contained in this rule. 
Potentially affected entities may include, but are not limited to:
     Manufacturers, importers, or processors of one or more 
subject chemical substances (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 these SNURs 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 this rule 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.

[[Page 20298]]

II. Background

A. What action is the agency taking?

    EPA is promulgating these SNURs using direct final procedures. 
These SNURs will require persons to notify EPA at least 90 days before 
commencing the manufacture, import, or processing of a chemical 
substance for any activity designated by these SNURs 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. Additional rationale and background to 
these rules are more fully set out in the preamble to EPA's first 
direct final SNUR published in the Federal Register issue of April 24, 
1990 (55 FR 17376) (April 24, 1990 SNUR). Consult that preamble for 
further information on the objectives, rationale, and procedures for 
SNURs and on the basis for significant new use designations, including 
provisions for developing test data.

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 III. 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.  [emsp14]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 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 sections 
5(h)(1), 5(h)(2), 5(h)(3), and 5(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 17 
chemical substances that are the subject of these SNURs, EPA considered 
relevant information about the toxicity of the chemical substances, 
likely human exposures and environmental releases associated with 
possible uses, and the four bulleted TSCA section 5(a)(2) factors 
listed in this unit.

IV. Substances Subject to This Rule

    EPA is establishing significant new use and recordkeeping 
requirements for 17 chemical substances in 40 CFR part 721, subpart E. 
In this unit, EPA provides the following information for each chemical 
substance:
     PMN number.
     Chemical name (generic name, if the specific name is 
claimed as CBI).
     Chemical Abstracts Service (CAS) number (if assigned for 
non-confidential chemical identities).
     Basis for the TSCA section 5(e) consent order or, for non-
section 5(e) SNURs (i.e., SNURs without TSCA section 5(e) consent 
orders), the basis for the SNUR.
     Toxicity concerns.
     Tests recommended by EPA to provide sufficient information 
to evaluate the chemical substance (see Unit VIII. for more 
information).
     CFR citation assigned in the regulatory text section of 
this rule.
    The regulatory text section of this rule specifies the activities 
designated as significant new uses. Certain new uses, including 
production volume limits (i.e., limits on manufacture and importation 
volume) and other uses designated in this rule, may be claimed as CBI. 
Unit IX. discusses a procedure companies may use to ascertain whether a 
proposed use constitutes a significant new use.
    This rule includes two PMN substances (P-10-486 and P-10-487) that 
are subject to ``risk-based'' consent orders under TSCA section 
5(e)(1)(A)(ii)(I) in which EPA determined that activities associated 
with the PMN substances may present unreasonable risk to human health 
or the environment. Those consent orders require protective measures to 
limit exposures or otherwise mitigate the potential unreasonable risk. 
The so-called ``5(e) SNURs'' on these PMN substances are promulgated 
pursuant to Sec.  [emsp14]721.160, and are based on and consistent with 
the provisions in the underlying consent orders. The 5(e) SNURs 
designate as a ``significant new use'' the absence of the protective 
measures required in the corresponding consent orders.
    This rule also includes SNURs on 15 PMN substances (P-09-248, P-11-
33, P-11-34, P-11-188, P-11-316, P-11-333, P-11-424, P-11-511, P-11-
546, P-11-578, P-11-580, P-11-591, P-11-608, P-11-637, and P-11-662) 
that are not subject to consent orders under TSCA section 5(e). In 
these cases, for a variety of reasons, EPA did not find that the use 
scenario described in the PMN triggered the determinations set forth 
under TSCA section 5(e). However, EPA does believe that certain changes 
from the use scenario described in the PMN could result in increased 
exposures, thereby constituting a ``significant new use.'' These so-
called ``non-5(e) SNURs'' are promulgated pursuant to Sec.  
[emsp14]721.170. EPA has determined that every activity designated as a 
``significant new use'' in all non-5(e) SNURs issued under Sec.  
[emsp14]721.170 satisfies the two requirements stipulated in Sec.  
721.170(c)(2), i.e., these significant new use activities, ``(i) are 
different from those described in the premanufacture notice for the 
substance, including any amendments, deletions, and additions of 
activities to the premanufacture notice, and (ii) may be accompanied by 
changes in exposure or release levels that are significant in relation 
to the health or environmental concerns identified'' for the PMN 
substance.

[[Page 20299]]

PMN Number P-09-248

    Chemical name: Ethyleneamine polyphosphates (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the use of the substance will 
be as a flame retardant added to polymers. Based on test data on the 
PMN substance, EPA predicts toxicity to aquatic organisms may occur if 
releases of the PMN substance to surface water from uses other than 
described in the PMN exceed the releases expected from the use 
described in the PMN. For the described use in the PMN, significant 
environmental releases are not expected. Therefore, EPA has not 
determined that the proposed manufacturing, processing, or use of the 
substance may present an unreasonable risk. EPA has determined, 
however, that any use of the substance other than as described in the 
PMN may cause significant adverse environmental effects. Based on this 
information, the PMN substance meets the concern criteria at Sec.  
721.170(b)(4)(i).
    Recommended testing: EPA has determined that the results of a fish 
early-life stage toxicity test (OPPTS Test Guideline 850.1400) and a 
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would 
help characterize the environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10282.

PMN Numbers P-10-486 and P-10-487

    Chemical names: (P-10-486) Poly[oxy(methyl-1,2-ethanediyl)], 
.alpha.-sulfo-.omega.-hydroxy-, C12-13-branched and linear alkyl 
ethers, sodium salts and (P-10-487) Poly[oxy(methyl-1,2-ethanediyl)], 
.alpha.-sulfo-.omega.-hydroxy-, C14-15-branched and linear alkyl 
ethers, sodium salts.
    CAS numbers: (P-10-486) 958238-81-8 and (P-10-487) 958238-82-9.
    Effective date of TSCA section 5(e) consent order: July 22, 2011.
    Basis for TSCA section 5(e) consent order: The PMNs state that the 
use of the substances will be for downhole injection for enhanced oil 
recovery. The order was issued under TSCA sections 5(e)(1)(A)(i), 
(e)(1)(A)(ii)(I), and (e)(1)(A)(ii)(II) based on a finding that these 
substances may present an unreasonable risk of injury to the 
environment and will be produced in substantial quantities and may 
reasonably be anticipated to enter the environment in substantial 
quantities. To protect against the risk, the order requires certain 
hazard communication requirements, specific disposal requirements for 
processing and use, and prohibits releases from manufacture of the PMN 
substances resulting in surface water concentrations exceeding 28 parts 
per billion (ppb) for P-10-486 and 4 ppb for P-10-487. The SNUR 
designates as a ``significant new use'' the absence of these protective 
measures.
    Toxicity concern: Based on ecological structure activity 
relationship (EcoSAR) analysis of test data on analogous anionic 
surfactants, EPA predicts toxicity to aquatic organisms may occur at 
concentrations that exceed 28 ppb for P-10-486 and 4 ppb for P-10-487 
in surface waters.
    Recommended testing: EPA has determined that the results of a fish 
acute toxicity test (OPPTS Test Guideline 850.1075); an aquatic 
invertebrate acute toxicity test, freshwater daphnids (OPPTS Test 
Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS 
Test Guideline 850.5400) on P-10-487 would help characterize the 
environmental effects of the PMN substances. The PMN submitter agreed 
not to exceed the production volume limit in the consent order before 
conducting these tests.
    CFR citations: 40 CFR 721.10283 (P-10-486) and 40 CFR 721.10284 (P-
10-487).

PMN Number P-11-33

    Chemical name: Formaldehyde, polymer with 4-(1,1-
dimethylethyl)phenol, reaction products with 1-piperazineethanamine.
    CAS number: 1191244-16-2.
    Basis for action: The PMN states that the PMN substance will be 
used as a hardener for epoxy resin laminating systems. Based on 
ecological structure activity relationship (EcoSAR) analysis of test 
data on analogous aliphatic amines and phenol-amines, EPA predicts 
toxicity to aquatic organisms may occur at concentrations that exceed 
17 ppb of the PMN substance in surface waters. As described in the PMN, 
the substance is not released to surface waters. Therefore, EPA has not 
determined that the proposed manufacture, processing, or use of the 
substance may present an unreasonable risk. EPA has determined, 
however, that any use of the substance resulting in surface water 
concentrations exceeding 17 ppb may cause significant adverse 
environmental effects. Based on this information, the PMN substances 
meet the concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
acute toxicity test, freshwater (OPPTS Test Guideline 850.1075); an 
aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS 
Test Guideline 850.1010); and an algal toxicity test, tiers I and II 
(OPPTS Test Guideline 850.5400) would help characterize the 
environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10285.

PMN Number P-11-34

    Chemical name: Formaldehyde, polymer with .alpha.-(2-
aminomethylethyl)-.omega.-(2-aminomethylethoxy)poly[oxy(methyl-1,2-
ethanediyl)] and 4-(1,1-dimethylethyl)phenol.
    CAS number: 1192146-78-3.
    Basis for action: The PMN states that the PMN substance will be 
used as a hardener for epoxy resin laminating systems. Based on EcoSAR 
analysis of test data on analogous aliphatic amines and phenol-amines, 
EPA predicts toxicity to aquatic organisms may occur at concentrations 
that exceed 21 ppb of the PMN substance in surface waters. As described 
in the PMNs, the substances are not released to surface waters. 
Therefore, EPA has not determined that the proposed manufacture, 
processing, or use of the substance may present an unreasonable risk. 
EPA has determined, however, that any use of the substance resulting in 
surface water concentrations exceeding 21 ppb may cause significant 
adverse environmental effects. Based on this information, the PMN 
substances meet the concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
acute toxicity test, freshwater (OPPTS Test Guideline 850.1075); an 
aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS 
Test Guideline 850.1010); and an algal toxicity test, tiers I and II 
(OPPTS Test Guideline 850.5400) would help characterize the 
environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10286.

PMN Number P-11-188

    Chemical name: Infused carbon nanostructures (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance is as an additive to provide 
conductive properties to reinforcements used in composites. Based on 
available information on analogous chemical substances, the PMN 
substance may cause lung effects. For the use described in the PMN, no 
significant inhalation exposures are expected. Therefore, EPA has not 
determined that the proposed manufacturing, processing, or use of the 
substance may present an unreasonable

[[Page 20300]]

risk. EPA has determined, however, that a manufacturing process other 
than as described in the PMN (the manufacturing process described in 
the PMN includes incorporation of the PMN substance into pellets) may 
cause serious health effects. Based on this information, the PMN 
substance meets the concern criteria at Sec.  721.170(b)(3)(ii).
    Recommended testing: EPA has determined that the results of the 
following information would help characterize the health effects of the 
PMN substance: The dimensions, characteristics, and physical-chemical 
properties of the carbon nanostructures. These properties should be 
determined once a year for three consecutive years.
    CFR citation: 40 CFR 721.10287.

PMN Number P-11-316

    Chemical name: Cyclohexane, oxidized, by-products from, distn. 
residues.
    CAS number: 1014979-92-0.
    Basis for action: The PMN states that the generic (non-
confidential) uses of the substance are as an industrial solvent in 
closed and open systems, and as an accelerant in permitted industrial 
explosives. Based on EcoSAR analysis of test data on analogous esters, 
EPA predicts toxicity to aquatic organisms may occur at concentrations 
that exceed 4 ppb of the PMN substance in surface waters. As described 
in the PMN, the substance is not released to surface waters. Therefore, 
EPA has not determined that the proposed manufacturing, processing, or 
use of the substance may present an unreasonable risk. EPA has 
determined, however, that any use of the substance resulting in surface 
water concentrations exceeding 4 ppb may cause significant adverse 
environmental effects. Based on this information, the PMN substance 
meets the concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
acute toxicity test, freshwater and marine (OPPTS Test Guideline 
850.1075); an aquatic invertebrate acute toxicity test, fresh water 
daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test, 
tiers I and II (OPPTS Test Guideline 850.5400) would help characterize 
the environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10288.

PMN Number P-11-333

    Chemical name: Hexanedioic acid polymer with aliphatic polyol 
dihydrogen phosphate aromatic ester (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use will be as a component of industrial coatings. Based 
on EcoSAR analysis of test data on analogous organic phosphates, EPA 
predicts toxicity to aquatic organisms may occur if releases of the PMN 
substance to surface water from uses other than described in the PMN 
exceed the releases expected from the use described in the PMN. For the 
described use in the PMN, significant environmental releases are not 
expected. Therefore, EPA has not determined that the proposed 
manufacturing, processing, or use of the substance may present an 
unreasonable risk. EPA has determined, however, that any use of the 
substance other than as described in the PMN may cause significant 
adverse environmental effects. Based on this information, the PMN 
substance meets the concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a ready 
biodegradability test (OPPTS Test Guideline 835.3110); a fish early-
life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid 
chronic toxicity test (OPPTS Test Guideline 850.1300); and an algal 
toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) would 
help characterize the environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10289.

PMN Number P-11-424

    Chemical name: Alkenoyloxy arylphenone (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance is as a monomer for polymer 
applications. Based on test data on the PMN substance, and EcoSAR 
analysis of test data on analogous methacrylates, EPA predicts toxicity 
to aquatic organisms may occur at concentrations that exceed 26 ppb of 
the PMN substance in surface waters. As described in the PMN, releases 
to surface waters are not expected to exceed 26 ppb. Therefore, EPA has 
not determined that the proposed manufacture, processing, or use of the 
substance may present an unreasonable risk. EPA has determined, 
however, that any use of the substance resulting in surface water 
concentrations exceeding 26 ppb may cause significant adverse 
environmental effects. Based on this information, the PMN substance 
meets the concern criteria at Sec.  721.170(b)(4)(i) and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
early-life stage toxicity test (OPPTS Test Guideline 850.1400) and a 
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would 
help characterize the environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10290.

PMN Number P-11-511

    Chemical name: C15 olefins (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a petroleum substitute 
base. Based on EcoSAR analysis of test data on analogous neutral 
organics, EPA predicts toxicity to aquatic organisms may occur at 
concentrations that exceed 1 ppb of the PMN substance in surface 
waters. As described in the PMN, the substance is not released to 
surface waters. Therefore, EPA has not determined that the proposed 
manufacturing, processing, or use of the substance may present an 
unreasonable risk. EPA has determined, however, that any use of the 
substance resulting in surface water concentrations exceeding 1 ppb may 
cause significant adverse environmental effects. Based on this 
information, the PMN substance meets the concern criteria at Sec.  
721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
early-life stage toxicity test (OPPTS Test Guideline 850.1400); a 
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an 
algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) 
would help characterize the environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10291.

PMN Number P-11-546

    Chemical name: Silicate (2-), hexafluoro-, cesium (1:2).
    CAS number: 16923-87-8.
    Basis for action: The PMN states that the PMN substance will be 
used as a brazing (metal joining) agent. Based on submitted test data 
for an analogous PMN substance, EPA identified concerns for 
degeneration of the kidneys, necrosis of the heart muscle, and effects 
on the male reproductive organs to workers from inhalation exposure to 
the PMN substance. For the uses described in the PMN, significant 
dermal or inhalation exposure is not expected. Therefore, EPA has not 
determined that the proposed manufacturing, processing, or use of the 
substance may present an unreasonable risk. EPA has determined, 
however, use of the substance other than as a brazing (metal joining) 
agent may cause serious health effects. Based on this information, the 
PMN substance meets

[[Page 20301]]

the concern criteria at Sec.  721.170(b)(3)(ii).
    Recommended testing: EPA has determined that the results of a 
repeated dose 28-day oral toxicity test (OPPTS Test Guideline 870.3050) 
in rodents would help characterize the human health effects of the PMN 
substance.
    CFR citation: 40 CFR 721.10292.

PMN Number P-11-578

    Chemical name: Benzoic acid, 4-(1,1-dimethylethyl)-, hydrazide.
    CAS number: 43100-38-5.
    Basis for action: The PMN states that the use of this substance 
will be as an intermediate. Based on SAR analysis of test data on 
analogous hydrazines, EPA identified concerns for mutagenicity, 
oncogenicity, developmental toxicity, dermal sensitization, and 
respiratory sensitization from exposure to the PMN substance via the 
inhalation route. In addition, based on EcoSAR analysis of analogous 
hydrazines, EPA predicts toxicity to aquatic organisms may occur at 
concentrations that exceed 2 ppb of the PMN substance in surface 
waters. For the intermediate use described in the PMN, inhalation 
exposures and environmental releases to surface waters are not 
expected. Therefore, EPA has not determined that the proposed 
manufacturing, processing, or use of the substance may present an 
unreasonable risk. EPA has determined, however, that any use of the 
substance other than as an intermediate, or any use resulting in 
surface water concentrations exceeding 2 ppb may cause serious health 
effects and significant adverse environmental effects. Based on this 
information, the PMN substance meets the concern criteria at Sec.  
721.170(b)(1)(i)(C), (b)(3)(ii), and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of a 90-
day oral toxicity test in rodents (OPPTS Test Guideline 870.3100) by 
the inhalation route; a carcinogenicity test (OPPTS Test Guideline 
870.4200) by the inhalation route, in two species of rodents; a fish 
acute toxicity test (OPPTS Test Guideline 850.1075); an aquatic 
invertebrate acute toxicity test, freshwater daphnids (OPPTS Test 
Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS 
Test Guideline 850.5400) would help characterize the human health and 
environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10293.

PMN Number P-11-580

    Chemical name: Cyclohexanol, 2,6-bis(1,1-dimethylethyl)-4-methyl-.
    CAS number: 163119-16-2.
    Basis for action: The PMN states that the use of this substance 
will be as an intermediate. Based on EcoSAR analysis of test data on 
analogous neutral organics, EPA predicts toxicity to aquatic organisms 
may occur at concentrations that exceed 2 ppb of the PMN substance in 
surface waters. As described in the PMN, releases to surface waters are 
not expected. Therefore, EPA has not determined that the proposed 
manufacturing, processing, or use of the substance may present an 
unreasonable risk. EPA has determined, however, that any use resulting 
in surface water concentrations exceeding 2 ppb may cause significant 
adverse environmental effects. Based on this information, the PMN 
substance meets the concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
acute toxicity test (OPPTS Test Guideline 850.1075); an aquatic 
invertebrate acute toxicity test, freshwater daphnids (OPPTS Test 
Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS 
Test Guideline 850.5400) would help characterize the environmental 
effects of the PMN substance.
    CFR citation: 40 CFR 721.10294.

PMN Number P-11-591

    Chemical name: IPDI modified isophthalic acid, neopentyl glycol and 
adipic acid (generic).
    CAS numbers: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a lamination adhesive. 
Based on test data on analogous substances, EPA identified concerns for 
oncogenicity, if the PMN substance is inhaled, as well as concerns for 
irritation to the eyes, skin, mucous membranes, and dermal and 
respiratory sensitization to workers from dermal and inhalation 
exposure to the PMN. For the industrial uses described in the PMN, and 
due to the use of personal protective equipment, significant worker 
exposure is unlikely, as dermal or inhalation exposure is not expected. 
Therefore, EPA has not determined that the proposed manufacturing, 
processing, or use of this substance may present an unreasonable risk. 
EPA has determined, however, that substantial production volume 
increases, or use of the substance in consumer products may cause 
serious health effects. Based on this information, the PMN substance 
meets the concern criteria at Sec.  721.170(b)(1)(i)(C) and (b)(3)(ii).
    Recommended testing: EPA has determined that the results of a 
dermal sensitization test (OPPTS Test Guideline 870.2600) and a 90-day 
inhalation toxicity test (OPPTS Test Guideline 870.3465) would help 
characterize the human health effects of the PMN substance.
    CFR citation: 40 CFR 721.10295.

PMN Number P-11-608

    Chemical name: 1,3-Benzenediol, 4-[1-[[3-(1H-imidazol-1-
yl)propyl]imino]ethyl]-.
    CAS number: 1313999-39-1.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an epoxy catalyst. Based 
on EcoSAR analysis of test data on polycationic polymers, EPA predicts 
toxicity to aquatic organisms may occur at concentrations that exceed 1 
ppb of the PMN substance in surface waters. As described in the PMN, 
the substance is not released to surface waters. Therefore, EPA has not 
determined that the proposed manufacturing, processing, or use of the 
substance may present an unreasonable risk. EPA has determined, 
however, that any use of the substance resulting in surface water 
concentrations exceeding 1 ppb may cause significant adverse 
environmental effects. Based on this information, the PMN substance 
meets the concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
acute toxicity test (OPPTS Test Guideline 850.1075); an aquatic 
invertebrate acute toxicity test, freshwater daphnids (OPPTS Test 
Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS 
Test Guideline 850.5400) would help characterize the environmental 
effects of the PMN substance. Additionally, EPA recommends that OPPTS 
Test Guideline 850.1000, ``Special Considerations for Conducting 
Aquatic Laboratory Studies'' be consulted for materials, such as this 
PMN substance, that are water insoluble or of low water solubility.
    CFR citation: 40 CFR 721.10296.

PMN Number P-11-637

    Chemical name: Tin, C16-18 and C18-unsatd. fatty acids castor-oil 
fatty acids complexes.
    CAS number: 1315588-63-6.
    Basis for action: The PMN states that the use of the substance will 
be as a polyurethane foam catalyst. Based on test data on the PMN 
substance, EPA identified concerns for dermal sensitization and blood 
and liver toxicity to workers from exposure to the PMN substance. For 
the industrial use described in the PMN, and due to the use of personal 
protective equipment,

[[Page 20302]]

significant worker exposure is unlikely, as dermal or inhalation 
exposure is not expected. Therefore, EPA has not determined that the 
proposed manufacturing, processing, or use of this substance may 
present an unreasonable risk. EPA has determined, however, that 
domestic manufacture of the substance or use of the substance in 
consumer products may cause serious health effects. Based on this 
information, the PMN substance meets the concern criteria at Sec.  
721.170(b)(3)(i).
    Recommended testing: EPA has determined that the results of a 28-
day dermal toxicity study (OPPTS Test Guideline 870.3200) would help 
characterize the human health effects of the PMN substance.
    CFR citation: 40 CFR 721.10297.

PMN Number P-11-662

    Chemical name: MDI terminated polyester polyurethane polymer 
(generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a liquid moisture cure 
adhesive. Based on test data on analogous diisocyanates, EPA identified 
concerns for mutagenicity, irritation to lungs and mucous membranes, 
and dermal and respiratory sensitization to workers from dermal and 
inhalation exposure to the PMN substance. For the industrial uses 
described in the PMN, and due to the use of personal protective 
equipment, significant worker exposure is unlikely, as dermal or 
inhalation exposure is not expected. Therefore, EPA has not determined 
that the proposed manufacturing, processing, or use of the substance 
may present an unreasonable risk. EPA has determined, however, that use 
of the substance in consumer products may cause serious health effects. 
Based on this information, the PMN substances meet the concern criteria 
at Sec.  721.170(b)(3)(ii).
    Recommended testing: EPA has determined that the results of a 
dermal sensitization test (OPPTS Test Guideline 870.2600) and a 90-day 
inhalation toxicity test (OPPTS Test Guideline 870.3465) would help 
characterize the human health effects of the PMN substance.
    CFR citation: 40 CFR 721.10298.

V. Rationale and Objectives of the Rule

A. Rationale

    During review of the PMNs submitted for the chemical substances 
that are subject to these SNURs, EPA concluded that for two of the 17 
chemical substances, regulation was warranted under TSCA section 5(e), 
pending the development of information sufficient to make reasoned 
evaluations of the health or environmental effects of the chemical 
substances. The basis for such findings is outlined in Unit IV. Based 
on these findings, TSCA section 5(e) consent orders requiring the use 
of appropriate exposure controls were negotiated with the PMN 
submitters. The SNUR provisions for these chemical substances are 
consistent with the provisions of the TSCA section 5(e) consent orders. 
These SNURs are promulgated pursuant to Sec.  [emsp14]721.160 (see Unit 
II.).
    In the other 15 cases, where the uses are not regulated under a 
TSCA section 5(e) consent order, EPA determined that one or more of the 
criteria of concern established at Sec.  [emsp14]721.170 were met, as 
discussed in Unit IV.

B. Objectives

    EPA is issuing these SNURs for specific chemical substances which 
have undergone premanufacture review because the Agency wants to 
achieve the following objectives with regard to the significant new 
uses designated in this rule:
     EPA will 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 will 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 will 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.
     EPA will ensure that all manufacturers, importers, and 
processors of the same chemical substance that is subject to a TSCA 
section 5(e) consent order are subject to similar requirements.
    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 https://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/.

VI. Direct Final Procedures

    EPA is issuing these SNURs as a direct final rule, as described in 
Sec.  [emsp14]721.160(c)(3) and Sec.  [emsp14]721.170(d)(4). In 
accordance with Sec.  [emsp14]721.160(c)(3)(ii) and Sec.  
[emsp14]721.170(d)(4)(i)(B), the effective date of this rule is June 4, 
2012 without further notice, unless EPA receives written adverse or 
critical comments, or notice of intent to submit adverse or critical 
comments before May 4, 2012.
    If EPA receives written adverse or critical comments, or notice of 
intent to submit adverse or critical comments, on one or more of these 
SNURs before May 4, 2012, EPA will withdraw the relevant sections of 
this direct final rule before its effective date. EPA will then issue a 
proposed SNUR for the chemical substance(s) on which adverse or 
critical comments were received, providing a 30-day period for public 
comment.
    This rule establishes SNURs for a number of chemical substances. 
Any person who submits adverse or critical comments, or notice of 
intent to submit adverse or critical comments, must identify the 
chemical substance and the new use to which it applies. EPA will not 
withdraw a SNUR for a chemical substance not identified in the comment.

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

    Significant new use designations for a chemical substance are 
legally established as of the date of publication of this direct final 
rule, April 4, 2012.
    To establish a significant ``new'' use, EPA must determine that the 
use is not ongoing. The chemical substances subject to this rule have 
undergone premanufacture review. TSCA section 5(e) consent orders have 
been issued for two chemical substances and the PMN submitters are 
prohibited by the TSCA section 5(e) consent orders from undertaking 
activities which EPA is designating as significant new uses. In cases 
where EPA has not received a notice of commencement (NOC) and the 
chemical substance has not been added to the TSCA Inventory, no other 
person may commence such activities without first submitting a PMN. For 
chemical substances for which an NOC has not been submitted at this 
time, EPA concludes that the uses are not ongoing. However, EPA 
recognizes that prior to the effective date of the rule, when chemical 
substances identified in this SNUR are added to the TSCA Inventory, 
other persons may engage in a significant new use as defined in this 
rule before the effective date of the rule. However, 7 of the 17 
chemical substances contained in this rule have CBI chemical 
identities, and since EPA has received a limited number of post-

[[Page 20303]]

PMN bona fide submissions (per Sec. Sec.  720.25 and 721.11), the 
Agency believes that it is highly unlikely that any of the significant 
new uses described in the regulatory text of this rule are ongoing.
    As discussed in the April 24, 1990 SNUR, 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 this direct 
final rule rather than as of the effective date of the rule. If uses 
begun after publication were considered ongoing rather than new, it 
would be difficult for EPA to establish SNUR notice requirements 
because a person could defeat the SNUR by initiating the significant 
new use before the rule became effective, and then argue that the use 
was ongoing before the effective date of the rule. Thus, persons who 
begin commercial manufacture, import, or processing of the chemical 
substances regulated through this SNUR will have to cease any such 
activity before the effective date of this rule. 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 
SNUR before the effective date. If a person meets the conditions of 
advance compliance under Sec.  721.45(h), the person is 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. In cases where EPA issued a 
TSCA section 5(e) consent order that requires or recommends certain 
testing, Unit IV. lists those tests. Unit IV. also lists recommended 
testing for non-5(e) SNURs. Descriptions of tests are provided for 
informational purposes. EPA strongly encourages persons, before 
performing any testing, to consult with the Agency pertaining to 
protocol selection. To access the harmonized test guidelines referenced 
in this document electronically, please go to https://www.epa.gov/ocspp 
and select ``Test Methods and Guidelines.''
    In the TSCA section 5(e) consent orders for two of the chemical 
substances regulated under this rule, EPA has established production 
volume limits in view of the lack of data on the potential health and 
environmental risks that may be posed by the significant new uses or 
increased exposure to the chemical substances. These limits cannot be 
exceeded unless the PMN submitter first submits the results of toxicity 
tests that would permit a reasoned evaluation of the potential risks 
posed by these chemical substances. Under recent TSCA section 5(e) 
consent orders, each PMN submitter is required to submit each study at 
least 14 weeks (earlier TSCA section 5(e) consent orders required 
submissions at least 12 weeks) before reaching the specified production 
limit. Listings of the tests specified in the TSCA section 5(e) consent 
orders are included in Unit IV. The SNURs contain the same production 
volume limits as the TSCA section 5(e) consent orders. Exceeding these 
production limits is defined as a significant new use. Persons who 
intend to exceed the production limit must notify the Agency by 
submitting a SNUN at least 90 days in advance of commencement of non-
exempt commercial manufacture, import, or processing.
    The recommended tests specified in Unit IV. 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. Procedural Determinations

    By this rule, EPA is establishing certain significant new uses 
which have been claimed as CBI subject to Agency confidentiality 
regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a 
final determination or other disposition of the confidentiality claim 
under 40 CFR part 2 procedures, EPA is required to keep this 
information confidential. EPA promulgated a procedure to deal with the 
situation where a specific significant new use is CBI, at 40 CFR 
721.1725(b)(1).
    Under these procedures a manufacturer, importer, or processor may 
request EPA to determine whether a proposed use would be a significant 
new use under the rule. The manufacturer, importer, or processor must 
show that it has a bona fide intent to manufacture, import, or process 
the chemical substance and must identify the specific use for which it 
intends to manufacture, import, or process the chemical substance. If 
EPA concludes that the person has shown a bona fide intent to 
manufacture, import, or process the chemical substance, EPA will tell 
the person whether the use identified in the bona fide submission would 
be a significant new use under the rule. Since most of the chemical 
identities of the chemical substances subject to these SNURs are also 
CBI, manufacturers, importers, and processors can combine the bona fide 
submission under the procedure in Sec.  721.1725(b)(1) with that under 
Sec.  721.11 into a single step.
    If EPA determines that the use identified in the bona fide 
submission would not be a significant new use, i.e., the use does not 
meet the criteria specified in the rule for a significant new use, that 
person can manufacture, import, or process the chemical substance so 
long as the significant new use trigger is not met. In the case of a 
production volume trigger, this means that the aggregate annual 
production volume does not exceed that identified in the bona fide 
submission to EPA. Because of confidentiality concerns, EPA does not 
typically disclose the actual production volume that constitutes the 
use trigger. Thus, if the person later intends to exceed that volume, a 
new bona fide submission would be necessary to determine whether that 
higher volume would be a significant new use.

[[Page 20304]]

X. 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 
submitted 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.

XI. 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 rule. EPA's complete economic 
analysis is available in the docket under docket ID number EPA-HQ-OPPT-
2011-0942.

XII. Statutory and Executive Order Reviews

A. Executive Order 12866

    This rule establishes SNURs for several new chemical substances 
that were the subject of PMNs, or TSCA section 5(e) consent orders. 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 is amending 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. 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 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 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, and (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 XI and 
EPA's experience promulgating SNURs (discussed in the certification), 
EPA believes that the following are true: (1) A significant number of 
SNUNs would not be submitted by small entities in response to the SNUR 
and (2) 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 rule. As 
such, EPA has determined that this 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 rule does not have Tribal implications because it is not 
expected to have substantial direct effects on Indian Tribes. This 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 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,

[[Page 20305]]

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).

XIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. 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 rule is not a 
``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects

40 CFR Part 9

    Environmental protection, Reporting and recordkeeping requirements.

40 CFR Part 721

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

    Dated: March 23, 2012.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and 
Toxics.

    Therefore, 40 CFR parts 9 and 721 are amended as follows:

PART 9--[AMENDED]

0
1. The authority citation for part 9 continues to read as follows:

    Authority:  7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 
2003, 2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 
9701; 33 U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 
1330, 1342, 1344, 1345(d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 
CFR, 1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 
300g, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-
2, 300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 
7542, 9601-9657, 11023, 11048.



0
2. The table in Sec.  9.1 is amended by adding the following sections 
in numerical order under the undesignated center heading ``Significant 
New Uses of Chemical Substances'' to read as follows:


Sec.  9.1  OMB approvals under the Paperwork Reduction Act.

* * * * *

------------------------------------------------------------------------
                                                           OMB  control
                     40 CFR citation                            No.
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
               Significant New Uses of Chemical Substances
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
721.10282...............................................       2070-0012
721.10283...............................................       2070-0012
721.10284...............................................       2070-0012
721.10285...............................................       2070-0012
721.10286...............................................       2070-0012
721.10287...............................................       2070-0012
721.10288...............................................       2070-0012
721.10289...............................................       2070-0012
721.10290...............................................       2070-0012
721.10291...............................................       2070-0012
721.10292...............................................       2070-0012
721.10293...............................................       2070-0012
721.10294...............................................       2070-0012
721.10295...............................................       2070-0012
721.10296...............................................       2070-0012
721.10297...............................................       2070-0012
721.10298...............................................       2070-0012
 
                                * * * * *
------------------------------------------------------------------------

* * * * *

PART 721--[AMENDED]

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

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



0
4. Add Sec.  721.10282 to subpart E to read as follows:


Sec.  721.10282  Ethyleneamine polyphosphates (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
ethyleneamine polyphosphates (PMN P-09-248) 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) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(j).
    (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), and (i) 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.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of 
this section.

0
5. Add Sec.  721.10283 to subpart E to read as follows:


Sec.  721.10283  Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-
sulfo-.omega.-hydroxy-, C12-13-branched and linear alkyl ethers, sodium 
salts.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as poly[oxy(methyl-
1,2-ethanediyl)], .alpha.-sulfo-.omega.-hydroxy-, C12-13-branched and 
linear alkyl ethers, sodium salts (PMN P-10-486; CAS No. 958238-81-8) 
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) Hazard communication program. Requirements as specified in 
Sec.  721.72(a), (b), (c), (d), (f), (g)(3)(i), (g)(3)(ii), (g)(4)(i), 
(g)(4)(ii), (g)(4)(iii), and (g)(5).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(p) (330,000 kilograms for this substance 
and P-10-487 combined).
    (iii) Disposal. Requirements as specified in Sec.  721.85(b)(1) and 
(c)(1) solvent rinsate resulting from cleaning of storage and holding 
tanks, shipboard tanks, iso containers, rail cars, and trucks used to 
transport the substance may only be disposed of by incineration. 
Sampling wastes containing the substance may only be disposed of by 
incineration, and Sec.  721.85(c)(3) for oilfield applications, when 
the substance will no longer be injected into a well at a particular 
site for enhanced oil recovery, the water rinsate of the field holding 
tank and any remaining field water containing the substance must be 
injected into a designated disposal well, either a class

[[Page 20306]]

I hazardous waste disposal well or another class II well.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4) (N = 28).
    (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), (f), (g), (h), (i), and (k) 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 significant new use rule.

0
6. Add Sec.  721.10284 to subpart E to read as follows:


Sec.  721.10284  Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-
sulfo-.omega.-hydroxy-, C14-15-branched and linear alkyl ethers, sodium 
salts.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as poly[oxy(methyl-
1,2-ethanediyl)], .alpha.-sulfo-.omega.-hydroxy-, C14-15-branched and 
linear alkyl ethers, sodium salts (PMN P-10-487; CAS No. 958238-82-9) 
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) Hazard communication program. Requirements as specified in 
Sec.  721.72(a), (b), (c), (d), (f), (g)(3)(i), (g)(3)(ii), (g)(4)(i), 
(g)(4)(ii), (g)(4)(iii), and (g)(5).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(p) (330,000 kilograms for this substance 
and for P-10-486 combined).
    (iii) Disposal. Requirements as specified in Sec.  721.85(b)(1) and 
(c)(1) solvent rinsate resulting from cleaning of storage and holding 
tanks, shipboard tanks, iso containers, rail cars, and trucks used to 
transport the substance may only be disposed of by incineration. 
Sampling wastes containing the substance may only be disposed of by 
incineration, and Sec.  721.85(c)(3) for oilfield applications, when 
the substance will no longer be injected into a well at a particular 
site for enhanced oil recovery, the water rinsate of the field holding 
tank and any remaining field water containing the substance must be 
injected into a designated disposal well, either a class I hazardous 
waste disposal well or another class II well.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4) (N = 4).
    (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), (f), (g), (h), (i), and (k) 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 significant new use rule.
* * * * *

0
7. Add Sec.  721.10285 to subpart E to read as follows:


Sec.  721.10285  Formaldehyde, polymer with 4-(1,1-
dimethylethyl)phenol, reaction products with 1-piperazineethanamine.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as formaldehyde, 
polymer with 4-(1,1-dimethylethyl)phenol, reaction products with 1-
piperazineethanamine (PMN P-11-33; CAS No. 1191244-16-2) 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) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) (N = 17 parts per billion (ppb)).
    (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), and (k) 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.

0
8. Add Sec.  721.10286 to subpart E to read as follows:


Sec.  721.10286  Formaldehyde, polymer with .alpha.-(2-
aminomethylethyl)-.omega.-(2-aminomethylethoxy)poly[oxy(methyl-1,2-
ethanediyl)] and 4-(1,1-dimethylethyl)phenol.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as formaldehyde, 
polymer with .alpha.-(2-aminomethylethyl)-.omega.-(2-
aminomethylethoxy)poly[oxy(methyl-1,2-ethanediyl)] and 4-(1,1-
dimethylethyl)phenol) (PMN P-11-34; CAS No. 1192146-78-3) 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) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) (N = 21 ppb).
    (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), and (k) 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.

0
9. Add Sec.  721.10287 to subpart E to read as follows:


Sec.  721.10287  Infused carbon nanostructures (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as infused 
carbon nanostructures (PMN P-11-188) 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) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(j) (manufacturing process described in the 
PMN; the process described in the PMN includes the incorporation of the 
PMN substance into pellets).
    (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) and (i) 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 significant new use rule.

0
10. Add Sec.  721.10288 to subpart E to read as follows:


Sec.  721.10288  Cyclohexane, oxidized, by-products from, distn. 
residues.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as cyclohexane, 
oxidized, by-products from, distn. residues (PMN P-11-316; CAS No. 
1014979-92-0) 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:

[[Page 20307]]

    (i) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) (N = 4 ppb).
    (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), and (k) 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 significant new use rule.

0
11. Add Sec.  721.10289 to subpart E to read as follows:


Sec.  721.10289  Hexanedioic acid polymer with aliphatic polyol 
dihydrogen phosphate aromatic ester (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
hexanedioic acid polymer with aliphatic polyol dihydrogen phosphate 
aromatic ester (PMN P-11-333) 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) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(j).
    (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), and (i) 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.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of 
this section.

0
12. Add Sec.  721.10290 to subpart E to read as follows:


Sec.  721.10290  Alkenoyloxy arylphenone (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alkenoyloxy arylphenone (PMN P-11-424) 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) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) (N = 26).
    (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), and (k) 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.

0
13. Add Sec.  [emsp14]721.10291 to subpart E to read as follows:


Sec.  [emsp14]721.10291  C15 olefins (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as C15 
olefins (PMN P-11-511) 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) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) (N = 1 ppb).
    (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), and (k) 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.

0
14. Add Sec.  [emsp14]721.10292 to subpart E to read as follows:


Sec.  [emsp14]721.10292  Silicate (2-), hexafluoro-, cesium (1:2).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as silicate (2-) 
hexafluoro-cesium (1:2) (PMN P-11-546; CAS No. 16923-87-8) 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) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(j) (use as brazing (metal joining) agent).
    (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), and (i) 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.

0
15. Add Sec.  721.10293 to subpart E to read as follows:


Sec.  [emsp14]721.10293  Benzoic acid, 4-(1,1-dimethylethyl)-, 
hydrazide.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as benzoic acid, 4-
(1,1-dimethylethyl)-, hydrazide (PMN P-11-578; CAS No. 43100-38-5) 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) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(g).
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) (N = 2 ppb).
    (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), (i), and (k) 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.

0
16. Add Sec.  [emsp14]721.10294 to subpart E to read as follows:


Sec.  [emsp14]721.10294  Cyclohexanol, 2,6-bis(1,1-dimethylethyl)-4-
methyl-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as cyclohexanol, 2,6-
bis(1,1-dimethylethyl)-4-methyl- (PMN P-11-580; CAS No. 163119-16-2) 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) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) (N = 2 ppb).
    (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), and (k) are

[[Page 20308]]

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.

0
17. Add new Sec.  721.10295 to subpart E to read as follows:


Sec.  721.10295  IPDI modified isophthalic acid, neopentyl glycol and 
adipic acid (generic).

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance identified generically as IPDI 
modified isophthalic acid, neopentyl glycol and adipic acid (PMN P-11-
591) 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) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o) and (s) (15,000 kilograms).
    (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), and (i) 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.

0
18. Add new Sec.  721.10296 to subpart E to read as follows:


Sec.  721.10296  1,3-Benzenediol, 4-[1-[[3-(lH-imidazol-1-
yl)propyl]imino] ethyl]-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1,3-benzenediol, 4-
[ 1-[[3-(lH-imidazol-1-yl)propyl]imino[ethyl]- (PMN P-11-608; CAS No. 
1313999-39-1) 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) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) (N = 1 ppb).
    (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), and (k) 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.

0
19. Add new Sec.  721.10297 to subpart E to read as follows:


Sec.  721.10297  Tin, C16-18 and C18-unsatd. fatty acids castor-oil 
fatty acids complexes.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance identified as tin, C16-18 and 
C18-unsatd. fatty acids castor-oil fatty acids complexes (PMN P-11-637; 
CAS No. 1315588-63-6) 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) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f) and (o).
    (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), and (i) 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.

0
20. Add new Sec.  721.10298 to subpart E to read as follows:


Sec.  721.10298  MDI terminated polyester polyurethane polymer 
(generic).

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance identified generically as MDI 
terminated polyester polyurethane polymer (P-11-662) 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) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o).
    (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), and (i) 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. 2012-8092 Filed 4-3-12; 8:45 am]
BILLING CODE 6560-50-P
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