80 FR 32003 - Significant New Use Rules on Certain Chemical Substances
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 80, Issue 108 (June 5, 2015)
Federal Register Volume 80, Issue 108 (June 5, 2015)
| Page Range | 32003-32017 | |
| FR Document | 2015-13670 |
[Federal Register Volume 80, Number 108 (Friday, June 5, 2015)] [Rules and Regulations] [Pages 32003-32017] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-13670] ======================================================================= ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 9 and 721 [EPA-HQ-OPPT-2015-0220; FRL-9927-67] RIN 2070-AB27 Significant New Use Rules on Certain Chemical Substances AGENCY: Environmental Protection Agency (EPA). ACTION: Direct final rule. ----------------------------------------------------------------------- SUMMARY: EPA is promulgating significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for 22 chemical substances which were the subject of premanufacture notices (PMNs). Two of these chemical substances are subject to TSCA section 5(e) consent orders issued by EPA. This action requires persons who intend to manufacture (including import) or process any of these 22 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 August 4, 2015. For purposes of judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on June 19, 2015. 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 July 6, 2015 (see Unit VI. of the SUPPLEMENTARY INFORMATION). 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 July 6, 2015, EPA will withdraw the relevant sections of this direct final rule before its effective date. 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-2015-0220, by one of the following methods:Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. 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: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets. 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: [email protected]. For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address: [email protected]. SUPPLEMENTARY INFORMATION: [[Page 32004]] I. General Information A. Does this action apply to me? You may be potentially affected by this action if you manufacture, process, or use the chemical substances contained in this rule. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include: Manufacturers or processors of one or more subject chemical substances (NAICS codes 325 and 324110), e.g., chemical manufacturing and petroleum refineries. 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 a proposed or final rule are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see Sec. 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D. 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 preparing and submitting your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html. 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 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) (FRL-3658-5). 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 or process the chemical substance for that use. Persons who must report are described in Sec. 721.5. C. Applicability of General Provisions General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the rule. Provisions relating to user fees appear at 40 CFR part 700. According to Sec. 721.1(c), persons subject to these SNURs must comply with the same SNUN requirements and EPA regulatory procedures as submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these requirements include the information submission requirements of TSCA section 5(b) and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA may take regulatory action under TSCA section 5(e), 5(f), 6, or 7 to control the activities for which it has received the SNUN. If EPA does not take action, EPA is required under TSCA section 5(g) to explain in the Federal Register its reasons for not taking action. III. Significant New Use Determination Section 5(a)(2) of TSCA states that EPA's determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors, including: The projected volume of manufacturing and processing of a chemical substance. The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance. The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance. The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance. In addition to these factors enumerated in TSCA section 5(a)(2), the statute authorized EPA to consider any other relevant factors. To determine what would constitute a significant new use for the 22 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 22 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) Registry number (assigned for non-confidential chemical identities). Basis for the TSCA section 5(e) consent order or, the basis for the TSCA non-section 5(e) SNURs (i.e., SNURs without TSCA section 5(e) consent orders). Tests recommended by EPA to provide sufficient information to [[Page 32005]] 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 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 2 PMN substances (P-13-930 and P-14-763) that are subject to ``risk-based'' consent orders under TSCA section 5(e)(1)(A)(ii)(I) where 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 ``TSCA section 5(e) SNURs'' on these PMN substances are promulgated pursuant to Sec. 721.160, and are based on and consistent with the provisions in the underlying consent orders. The TSCA section 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 20 PMN substances 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 ``TSCA non-section 5(e) SNURs'' are promulgated pursuant to Sec. 721.170. EPA has determined that every activity designated as a ``significant new use'' in all TSCA non-section 5(e) SNURs issued under Sec. 721.170 satisfies the two requirements stipulated in Sec. 721.170(c)(2), i.e., these significant new use activities 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 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. PMN Number P-11-549 Chemical name: 2-Butene, 1,1,1,4,4,4-hexafluoro-, (2Z)-. CAS number: 692-49-9. Basis for action: The PMN states that the generic (non- confidential) use of the substance will be as a heat transfer fluid. Based on test data on the PMN substance as well as structure activity relationship (SAR) analysis of analogous small fluorinated compounds, EPA identified concerns for cardiac sensitization, developmental toxicity, neurotoxicity, reproductive toxicity and oncogenicity from inhalation exposures to the PMN substance. As described in the PMN, occupational exposures are expected to be minimal due to no domestic manufacture and consumer exposure is not expected due to no use of the substance in a consumer product. Therefore, EPA has not determined that the proposed processing or use of the substance may present an unreasonable risk. EPA has determined, however, that any domestic manufacture, any use other than as described in the PMN, or any use of the substance in a consumer product may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at Sec. 721.170(b)(3)(i) and (b)(3)(ii). Recommended testing: EPA has determined that inhalation monitoring data, collected according to the EPA draft Inhalation Monitoring Data Collection Guidelines (located in the docket under docket ID number EPA-HQ-OPPT-2015-0220) would help characterize the human health effects of the PMN substance. CFR citation: 40 CFR 721.10830. PMN Number P-13-690 Chemical name: Aluminum phosphate (generic). CAS number: Claimed confidential. Basis for action: The PMN states that the substance will be used as a flame retardant for industrial plastics. Based on SAR analysis of test data on analogous respirable, poorly soluble particulates, EPA identified concerns for lung effects, blood toxicity, hypersensitivity, developmental neurotoxicity, and immunotoxicity from inhalation exposures to the PMN substance. Further, based on ecological SAR analysis of test data on analogous aluminum salts, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 87 parts per billion (ppb) of the PMN substance in surface waters. As described in the PMN, occupational exposures are expected to be minimal due to use of respiratory protection, and releases of the substance are not expected to result in surface water concentrations that exceed 87 ppb. 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 PMN substance without the use of National Institute of Occupational Safety and Health (NIOSH)-certified respirator with an assigned protection factor (APF) of at least 10, where inhalation exposures are expected, or any use of the substance resulting in surface water concentrations exceeding 87 ppb may cause serious human health effects and significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at 40 CFR 721.170(b)(3)(ii) and (b)(4)(ii). Recommended testing: EPA has determined that the results of a 90- day inhalation toxicity test (OPPTS Test Guideline 870.3465 or Organisation for Economic Co-operation and Development (OECD) Test Guideline 413); 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 (Office of Chemical Safety and Pollution Prevention (OCSPP) Test Guideline 850.4500) would help characterize the human health and environmental effects of the PMN substance. EPA also recommends that the guidance document on aquatic toxicity testing of difficult substance and mixtures (OECD Test Guideline 23) be consulted to facilitate solubility of the PMN substance in the test media. CFR citation: 40 CFR 721.10831. PMN Number P-13-872 Chemical name: Alkyl triazine (generic). CAS number: Claimed confidential. Basis for action: The PMN states that the substance will be used in the removal of hydrogen sulfide. Based on test data on the PMN substance, as well as ecological SAR analysis of test data on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 130 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 130 ppb. 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 130 ppb may [[Page 32006]] 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 721.10832. PMN Number P-13-930 Chemical name: Substituted bis 2,6-xylenol (generic). CAS number: Claimed confidential. Effective date of TSCA section 5(e) consent order: December 10, 2014. Basis for TSCA section 5(e) consent order: The PMN states that the generic (non-confidential) use of the substance will be as a reactant in polymerization reactions. Based on SAR analysis of test data on structurally similar substances, EPA identified concerns for liver, kidney and developmental toxicity; blood effects, sensitization, and endocrine disruption. Further, based on test data on the PMN substance, EPA predicts toxicity to aquatic organisms at concentrations that exceed 6 ppb of the PMN substance in surface waters. The order was issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I), based on a finding that the substance may present an unreasonable risk of injury to the environment and human health, and there may be significant (or substantial) human exposure to the substance. To protect against these exposures and risks, the consent order requires: 1. Use of personal protective equipment involving impervious gloves and protective clothing (where there is a potential for dermal exposure) and a NIOSH-certified respirator with an APF of at least 50 (where there is a potential for inhalation exposure). 2. Establishment and use of a hazard communication program, including human health, environmental hazard precautionary statements on each label and the MSDS. 3. Manufacturing, processing, or use of the PMN substance only as an intermediate. 4. Submission of certain toxicity testing prior to exceeding the confidential production volume limits of the PMN substance specified in the consent order. 5. No predictable or purposeful release of the PMN substance from manufacturing, processing or use into the waters of the United States that result in surface water concentrations exceeding 6 ppb. The SNUR designates as a ``significant new use'' the absence of these protective measures. Recommended testing: EPA has determined that the results of certain toxicity testing, identified in the TSCA 5(e) consent order would help characterize possible effects of the substance. The submitter has agreed not to exceed the first confidential volume limit without performing an aromatase (human recombinant) test (OCSPP Test Guideline 890.1200) and a steroidogenesis (human cell line-H295R) test (OCSPP Test Guideline 890.1550 or OECD Test Guideline 456). Further, the Order prohibits the Company from exceeding the second confidential production volume limit unless the Company submits the Tier 2 testing described in the Testing section of this Order in accordance with the conditions specified in the Testing section. CFR citation: 40 CFR 721.10833. PMN Number P-14-20 Chemical name: Heteropolycyclic diacrylate (generic). CAS number: Claimed confidential. Basis for action: The PMN states that the generic (non- confidential) use of the substance will be as a coating resin. Based on test data on the PMN, EPA identified concerns for dermal and ocular irritation, and systemic toxicity from the dermal, ocular, and oral routes. Further, based on ecological SAR analysis of test data on analogous acrylates, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 120 ppb of the PMN substance in surface waters. As described in the PMN, occupational exposures are expected to be minimal due to the use of impervious gloves, goggles, and a NIOSH-certified particulate respirator with an APF of at least 10. Further, releases of the substance are not expected to result in surface water concentrations that exceed 120 ppb. 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 without the use of impervious gloves and goggles, when there is a potential dermal exposure; any use of the substance without a NIOSH-certified particulate respirator with an APF of at least 10, where there is a potential for inhalation exposures; or any use of the substance resulting in surface water concentrations exceeding 120 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)(3)(i) and (b)(4)(ii). Recommended testing: EPA has determined that the results of a combined repeated dose toxicity with the reproduction/developmental toxicity screening test (OPPTS Test Guideline 870.3650); 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 (OCSPP Test Guideline 850.4500) would help characterize the human health and environmental effects of the PMN substance. CFR citation: 40 CFR 721.10834. PMN Number P-14-66 Chemical name: 1,6-Hexanediamine, N1-(6-aminohexyl)-, polymer with 2-(chloromethyl)oxirane, N-(dithiocarboxy) derivs., sodium salts. CAS number: 1459738-70-5. Basis for action: The PMN states that the substance will be used as a water clarifier intermediate. Based on ecological SAR analysis of test data on analogous dithiocarbamates, 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, releases of the substance are not expected to result in surface water concentrations that exceed 1 ppb. 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 that results 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 mysid acute toxicity test (OCSPP Test Guideline 850.1035); a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an acute invertebrate toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.10835. PMN Number P-14-209 Chemical name: Dimethylaminoalkyl alkene amide (generic). CAS number: Claimed confidential. [[Page 32007]] Basis for action: The PMN states that the generic (non- confidential) use of the substance will be as an adjuvant for non- Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)-regulated agricultural use products, an additive for pesticide formulations, and an additive for fertilizer formulations. Based on test data on the PMN substance, as well as ecological SAR analysis of test data on analogous amides and aliphatic amines, EPA predicts chronic toxicity to aquatic organisms may occur at concentrations that exceed 4 ppb of the PMN substance in surface waters for greater than 20 days per year. This 20- day criterion is derived from partial life cycle tests (daphnid chronic and fish early-life stage tests) that typically range from 21 to 28 days in duration. EPA predicts toxicity to aquatic organisms may occur if releases of the PMN substance to surface water exceed releases from the use described in the PMN. For the uses described in the PMN, environmental releases did not exceed the concentration of concern for more than 20 days per year. 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 other than as described in the PMN may cause significant adverse environmental effects. Based on this information, the PMN substances meet 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 721.10836. PMN Number P-14-452 Chemical name: Substituted naphthalene polymer glycidyl ether (generic). CAS number: Claimed confidential. Basis for action: The PMN states that the generic (non- confidential) uses of the substance will be as a matrix resin for composite materials and a binder resin for electronic materials. Based on ecological SAR analysis of test data on analogous polyepoxides, 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, releases of the substance are not expected to result in surface water concentrations that exceed 1 ppb. 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 (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.10837. PMN Number P-14-473 Chemical name: Alkylpolycarboxylic acid, derivative, tris(fluorinatedalkoxy)alkyl ester salt (generic). CAS number: Claimed confidential. Basis for action: The PMN states that the generic (non- confidential) use of the substance will be for coatings and printing applications. Based on ecological SAR analysis of test data on analogous anionic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 6 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 6 ppb. 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 6 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 water solubility study (OECD Test Guideline 105); a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); 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 721.10838. PMN Number P-14-476 Chemical name: Tricyclo[3.3.1.13,7]decan-1-amine, N,N-dimethyl-. CAS number: 3717-40-6. Basis for action: The PMN states that the generic (non- confidential) use of the substance will be as an isolated intermediate. Based on ecological SAR analysis of test data on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 8 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 8 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined that any use of the substance resulting in surface water concentrations exceeding 8 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 (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.10839. PMN Number P-14-510 Chemical name: Sulfosuccinic acid ester, alkylamine derivs., sodium salt (generic). CAS number: Claimed confidential. Basis for action: The PMN states that the generic (non- confidential) use of the substance will be as an industrial leather softener. Based on test data on the PMN substance as well as SAR analysis of test data on analogous anionic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 94 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 94 ppb. 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 94 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets [[Page 32008]] 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 721.10840. PMN Number P-14-603 Chemical name: Bismuth nitrate oxide (Bi 3 (NO3 )O4 ). CAS number: 1417164-49-8. Basis for action: The PMN states that the generic (non- confidential) use of the substance will be as a proprietary degradation inhibitor additive in polymer-based insulation sheets. Based on test data on analogous respirable, poorly soluble particulates, EPA identified concerns for lung effects from inhalation exposures to the PMN substance. For the use described in the PMN, significant inhalation exposures 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 listed in the PMN, or without respiratory protection, 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 a 90- day inhalation toxicity study with a 60-day holding period (OPPTS Test Guideline 870.3465) would help characterize the human health effects of the PMN substance. CFR citation: 40 CFR 721.10841. PMN Number P-14-605 Chemical name: Substituted cyclosiloxane (generic). CAS number: Claimed confidential. Basis for action: The PMN states that the use of the substance will be as a refractive index modifier component for light-emitting diode (LED) chips. Based on the physical/chemical properties of the PMN substance (as described in the New Chemical Program's PBT category at 64 FR 60194; November 4, 1999) and test data on structurally similar substances, the PMN substance is a potentially persistent, bioaccumulative, and toxic (PBT) chemical. EPA estimates that the PMN substance will persist in the environment more than 2 months and estimates a bioaccumulation factor of greater than or equal to 1,000. As described in the PMN notice, the PMN substance will not be released to water. 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 or resulting in releases to water 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)(3)(ii), (b)(4)(ii), and (b)(4)(iii). Recommended testing: EPA has determined that the results of a partition coefficient (n-octanol/water) test, estimation by liquid chromatography (OPPTS Test Guideline 830.7570 or OECD Test Guideline 117); a ready biodegradability test (OPPTS Test Guideline 835.3110 or OECD Test Guideline 301); a fish bioconcentration factor (BCF) test (OPPTS Test Guideline 850.1730 or (OECD Test Guideline 305); and a water solubility test (OECD Test Guideline 111) would help characterize the health and environmental effects of the PMN substance. Depending on the results of these tests, additional testing as identified in the PBT category may be recommended. CFR citation: 40 CFR 721.10842. PMN Numbers P-14-666 and P-14-668 Chemical names: Substituted amide aromatic carboxylic acid, metal salt (generic). CAS numbers: Claimed confidential. Basis for action: The PMNs state that the generic (non- confidential) use of the substances will be as morphology modifiers for plastics. Based on ecological SAR analysis of test data on analogous amides, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 67 ppb of the PMN substance (P-14-666) and 39 ppb of the PMN substance (P-14-668) in surface waters for greater than 20 days per year. This 20-day criterion is derived from partial life cycle tests (daphnid chronic and fish early-life stage tests) that typically range from 21 to 28 days in duration. EPA predicts toxicity to aquatic organisms may occur if releases of the substances to surface water, from uses other than as described in the PMNs, exceed releases from the uses described in the PMNs. For the use described in the PMNs, environmental releases did not exceed 67 ppb (P-14-666) and 39 ppb (P- 14-668) for more than 20 days per year. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substances may present an unreasonable risk. EPA has determined, however, that any use of the substances other than as listed in the PMNs 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 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 (OCSPP Test Guideline 850.4500) on each PMN substance would help characterize their environmental effects. CFR citation: 40 CFR 721.10843. PMN Number P-14-763 Chemical name: Graphene nanoplatelets having a predominant thickness of 1-10 layers with lateral dimension predominantly less than 2 microns. CAS number: Not Available Effective date of TSCA section 5(e) consent order: December 30, 2014. Basis for TSCA section 5(e) consent order: The PMN states that the generic (non-confidential) use of the substance will be in printed electronics, solar energy, separations, and functional composites. Based on SAR analysis of test data on respirable, poorly soluble particulates and analogous carbon nanomaterials, EPA identified concerns for pulmonary toxicity, oncogenicity, immunotoxicity, fibrosis, and lung toxicity from lung overload. The order was issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I), based on a finding that these substance may present an unreasonable risk of injury to the environment and human health, and there may be significant (or substantial) human exposure to the substance. To protect against these exposures and risks, the consent order requires: 1. Use of personal protective equipment involving impervious gloves and protective clothing (where there is a potential for dermal exposure) and a NIOSH-certified respirator (where there is a potential for inhalation exposure). 2. Establishment and use of a hazard communication program, including human health, environmental hazard precautionary statements on each label and the MSDS. 3. Manufacturing, processing, or use of the PMN substance only as described in the consent order. 4. No use of the PMN substance using an application method that generates a vapor, mist, or aerosol. 5. Submission of certain toxicity testing prior to exceeding the confidential production volume limits [[Page 32009]] of the PMN substances specified in the consent order. 6. No predictable or purposeful release of the PMN substances from manufacturing, processing or use into the waters of the United States. The SNUR designates as a ``significant new use'' the absence of these protective measures. Recommended testing: EPA has determined that the results of certain particle size distribution and material characterization testing would be needed for the PMN substance. The company has agreed to submit the full chemical characterization testing described in the testing section of the consent order within the timeframes identified in the order. Further, depending on the results of the characterization testing, additional toxicity testing may be required at a confidential aggregate manufacture volume, as detailed in the consent order. CFR citation: 40 CFR 721.10844. PMN Number P-14-781 Chemical name: Methanaminium, N-[4-[[4- (dimethylamino)phenyl]phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N- methyl-, ethanedioate, ethanedioate (2:2:1). CAS number: 2437-29-8. Basis for action: The PMN states that the generic (non- confidential) use of the substance will be as a component of industrial inks and dyes. Based on test data on analogous malachite green chloride, pararosaniline, gentian violet, crystal violet, oxalic acid, and other analogous substances, EPA identified concerns for mutagenicity, carcinogenicity, eye irritation, as well as kidney, acute, and developmental toxicities for occupational inhalation exposures and general population exposures from drinking water exposures. In addition, based on ecological SAR analysis of test data on analogous cationic dyes, 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, occupational exposures during processing and use activities are expected to be minimal. Further, releases of the PMN substance are not expected to result in surface water concentrations that exceed 1 ppb. Therefore, EPA has not determined that the proposed processing or use of the substance may present an unreasonable risk. EPA has determined, however, that any domestic manufacture of the substance, or any release of the substance resulting in surface water concentrations exceeding 1 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)(3)(ii) and (b)(4)(ii). Recommended testing: EPA has determined that the results of a combined repeated dose toxicity with the reproduction/developmental toxicity screening test (OECD Test Guideline 422); a bacterial reverse mutation test (OECD Test Guideline 471); an in vitro mammalian chromosome aberration test (OECD Test Guideline 473); a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the human health an environmental effects of the PMN substance. CFR citation: 40 CFR 721.10845. PMN Number P-14-811 Chemical name: Sulfurized hydrocarbon (generic). CAS number: Claimed confidential. Basis for action: The PMN states that the use of the substance will be as a lubricant additive. Based on ecological SAR analysis of test data on analogous neutral organics, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the low molecular weight components of PMN substance in surface waters. As described in the PMN, where 80 percent of the molecular weight species is greater than 1,000 daltons, releases of the substance are not expected to result in surface water concentrations that exceed 1 ppb of the low molecular weight components. 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 where less than 80 percent of the molecular weight species is greater than 1,000 daltons, 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 an inherent biodegradability Zahn-Wellens test (OECD Test Guideline 302); an aerobic and anaerobic transformation in soil test (OECD Test Guideline 307); a fish BCF test: Aqueous and dietary exposure (OECD Test Guideline 305); a bioaccumulation in sediment-dwelling benthic oligochaetes test (OECD Test Guideline 315); a sediment-water chironomid toxicity test using spiked sediment (OECD Test Guideline 218); 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 (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.10846. PMN Number P-14-821 Chemical name: Oxiranemethanaminium, N,N,N-trimethyl-, bromide. CAS number: 13895-77-7. Basis for action: The PMN states that the substance will be used as an intermediate for polymer production. Based on test data on analogous epoxides, EPA identified concerns for skin and lung sensitization, mutagenicity, oncogenicity, developmental toxicity, male reproductive, liver, and kidney toxicity from dermal and inhalation exposures. Further, based on ecological SAR analysis of test data on analogous quaternary ammonium compounds, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 28 ppb of the PMN substance in surface waters. As described in the PMN, particulate exposures are not expected and releases of the substance are not expected to result in surface water concentrations that exceed 28 ppb. 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 manufacture, processing, or use of the substance in the form of a powder or any use of the substance resulting in surface water concentrations exceeding 28 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)(3)(ii) and (b)(4)(ii). Recommended testing: EPA has determined that the results of a 90- day inhalation toxicity test (OPPTS Test Guideline 870.3465); a bacterial reverse mutation test (OPPTS Test Guideline 870.5100); a ready biodegradability test (OECD Test Guideline 301D) closed bottle method; 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 (OCSPP Test Guideline 850.4500) would help characterize the human health and environmental effects of the PMN substance. CFR citation: 40 CFR 721.10847. [[Page 32010]] PMN Number P-14-875 Chemical name: Aryloxyalkyl amine (generic). CAS number: Claimed confidential. Basis for action: The PMN states that the substance will be used as an intermediate. Based on test data on the PMN substance and SAR analysis of test data on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 44 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 44 ppb. 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 44 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 ready biodegradability test (OECD Test Guideline 301) and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.10848. PMN Numbers P-15-115 and P-15-116 Chemical names: (P-15-115) Phenol-biphenyl-formaldehyde polycondensate (generic); (P-15-116) Polymer of phenol, biphenyl and resorcinol (generic). CAS numbers: Claimed confidential. Basis for action: The PMNs state that the generic (non- confidential) use of the substances will be in electric molding. Based on test data on the PMN substances as well as SAR analysis of test data on analogous phenols, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 5 ppb of the PMN substances in surface waters. As described in the PMNs, releases of the substances are not expected to result in surface water concentrations that exceed 5 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substances may present an unreasonable risk. EPA has determined, however, that any use resulting in surface water concentrations exceeding 5 ppb may cause significant adverse environmental effects. Based on this information, the PMN substances meet the concern criteria at Sec. 721.170(b)(4)(i) and (b)(4)(ii). Recommended testing: EPA has determined that the results of a water solubility test (OECD Test Guideline 105); 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 substances. Testing may be conducted on either P-15-115 or P-15-116 and results should include a GPC analysis of molecular weight distribution. CFR citations: 40 CFR 721.10849 (P-15-115) and 40 CFR 721.10850 (P- 15-116) 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 2 of the 22 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. 721.160 (see Unit VI.). In the other 20 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. 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 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 or processing a listed chemical substance for the described significant new use. EPA will be able to regulate prospective manufacturers 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 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 Chemical Substance Inventory (TSCA Inventory). Guidance on how to determine if a chemical substance is on the TSCA Inventory is available on the Internet at http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html. VI. Direct Final Procedures EPA is issuing these SNURs as a direct final rule, as described in Sec. 721.160(c)(3) and Sec. 721.170(d)(4). In accordance with Sec. 721.160(c)(3)(ii) and Sec. 721.170(d)(4)(i)(B), the effective date of this rule is August 4, 2015 without further notice, unless EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments before July 6, 2015. 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 July 6, 2015, 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 the Significant New Use Designation 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. 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 person may commence such activities without first submitting a PMN. Therefore, for chemical substances for which an NOC [[Page 32011]] has not been submitted EPA concludes that the designated significant new uses are not ongoing. When chemical substances identified in this rule are added to the TSCA Inventory, EPA recognizes that, before the rule is effective, other persons might engage in a use that has been identified as a significant new use. However, TSCA section 5(e) consent orders have been issued for 2 of the 22 chemical substances, and the PMN submitters are prohibited by the TSCA section 5(e) consent orders from undertaking activities which would be designated as significant new uses. The identities of 16 of the 22 chemical substances subject to this rule have been claimed as confidential and EPA has received no post-PMN bona fide submissions (per Sec. Sec. 720.25 and 721.11). Based on this, 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. Therefore, EPA designates June 5, 2015 as the cutoff date for determining whether the new use is ongoing. Persons who begin commercial manufacture or processing of the chemical substances for a significant new use identified as of that date would have to cease any such activity upon the effective date of the final rule. To resume their activities, these persons would have to first comply with all applicable SNUR notification requirements and wait until the notice review period, including any extensions, expires. If such a person met the conditions of advance compliance under Sec. 721.45(h), the person would be considered exempt from the requirements of the SNUR. Consult the Federal Register document of April 24, 1990 for a more detailed discussion of the cutoff date for ongoing uses. 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 40 CFR 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 OCSPP test guidelines referenced in this document electronically, please go to http://www.epa.gov/ocspp and select ``Test Methods and Guidelines.'' The Organisation for Economic Co-operation and Development (OECD) test guidelines are available from the OECD Bookshop at http://www.oecdbookshop.org or SourceOECD at http://www.sourceoecd.org. In the TSCA section 5(e) consent orders for several 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 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, 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 or processor may request EPA to determine whether a proposed use would be a significant new use under the rule. The manufacturer or processor must show that it has a bona fide intent to manufacture or process the chemical substance and must identify the specific use for which it intends to manufacture or process the chemical substance. If EPA concludes that the person has shown a bona fide intent to manufacture 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 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 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 [[Page 32012]] exceed that volume, a new bona fide submission would be necessary to determine whether that higher volume would be a significant new use. X. SNUN Submissions According to Sec. 721.1(c), persons submitting a SNUN must comply with the same notification requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in 40 CFR 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 40 CFR 720.40 and Sec. 721.25. E-PMN software is available electronically at http://www.epa.gov/opptintr/newchems. XI. Economic Analysis EPA has evaluated the potential costs of establishing SNUN requirements for potential manufacturers 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-2015-0220. XII. Statutory and Executive Order Reviews A. Executive Order 12866 This action 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 (PRA) According to 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 action. 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 (RFA) On February 18, 2012, EPA certified pursuant to RFA section 605(b) (5 U.S.C. 601 et seq.), that promulgation of a SNUR does not have a significant economic impact on a substantial number of small entities where the following are true: 1. A significant number of SNUNs would not be submitted by small entities in response to the SNUR. 2. The SNUR 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 action. This action 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: A significant number of SNUNs would not be submitted by small entities in response to the SNUR. Submission of the SNUN would not cost any small entity significantly more than $8,300. Therefore, the promulgation of the SNUR would not have a significant economic impact on a substantial number of small entities. D. Unfunded Mandates Reform Act (UMRA) 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 action. As such, EPA has determined that this action does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.). 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 action does not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This action 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 action. 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 [[Page 32013]] Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001), because this action is not expected to affect energy supply, distribution, or use and because this action is not a significant regulatory action under Executive Order 12866. I. National Technology Transfer and Advancement Act (NTTAA) In addition, since this action does not involve any technical standards, NTTAA 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 Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a ``major rule'' as defined by 5 U.S.C. 804(2). List of Subjects 40 CFR Part 9 Environmental protection, Reporting and recordkeeping requirements. 40 CFR Part 721 Environmental protection, Chemicals, Hazardous substances, Reporting and recordkeeping requirements. Dated: May 28, 2015. 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. In Sec. 9.1, add 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 ------------------------------------------------------------------------ * * * * * ------------------------------------------------------------------------ 721.10830.................................................. 2070-0012 721.10831.................................................. 2070-0012 721.10832.................................................. 2070-0012 721.10833.................................................. 2070-0012 721.10834.................................................. 2070-0012 721.10835.................................................. 2070-0012 721.10836.................................................. 2070-0012 721.10837.................................................. 2070-0012 721.10838.................................................. 2070-0012 721.10839.................................................. 2070-0012 721.10840.................................................. 2070-0012 721.10841.................................................. 2070-0012 721.10842.................................................. 2070-0012 721.10843.................................................. 2070-0012 721.10844.................................................. 2070-0012 721.10845.................................................. 2070-0012 721.10846.................................................. 2070-0012 721.10847.................................................. 2070-0012 721.10848.................................................. 2070-0012 721.10849.................................................. 2070-0012 721.10850.................................................. 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. 721.10830 to subpart E to read as follows: Sec. 721.18030 2-Butene, 1,1,1,4,4,4-hexafluoro-, (2Z)-. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 2-butene, 1,1,1,4,4,4-hexafluoro-, (2Z)- (PMN P-11-549; CAS No. 692-49-9) 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) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(f), (j), 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) through (c), and (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 5. Add Sec. 721.10831 to subpart E to read as follows: Sec. 721.18031 Aluminum phosphate (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as aluminum phosphate (PMN P-13-690) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the PMN substance that has been completely reacted (cured) or entrained into a polymer matrix. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(4) and (a)(6)(1). When determining which persons are reasonably likely to be exposed as required for Sec. 721.63(a)(4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. A National Institute for Occupational Safety and Health (NIOSH)-certified respirator with an Assigned Protection Factor (APF) of at least 10 meet the requirements of Sec. 721.63(a)(4). (ii) Release to water. Requirements as specified in Sec. 721.90(a)(4), (b)(4), and (c)(4) (N=87). (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) through (e), and (k) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. [[Page 32014]] 0 6. Add Sec. 721.10832 to subpart E to read as follows: Sec. 721.10832 Alkyl triazine (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkyl triazine (PMN P-13-872) 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=130). (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) through (c), and (k) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 7. Add Sec. 721.10833 to subpart E to read as follows: Sec. 721.10833 Substituted bis 2,6-xylenol (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as substituted bis 2,6-xylenol (PMN P-13-930) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the PMN substance that have been incorporated into an article or has been incorporated into a polymer matrix. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(2)(i), (a)(3), (a)(4), (a)(6)(i), (a)(6)(ii), (b)(concentration set at 1.0 percent), and (c). When determining which persons are reasonably likely to be exposed as required for Sec. 721.63(a)(4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. The following National Institute for Occupational Safety and Health (NIOSH)-certified respirators with an assigned protection factor (APF) of at least 50 meet the requirements of Sec. 721.63(a)(4): (A) NIOSH-certified power air-purifying respirator with a hood or helmet and with appropriate gas/vapor (acid gas, organic vapor, or substance specific) cartridges in combination with HEPA filters. (B) NIOSH-certified continuous flow supplied-air respirator equipped with a loose fitting facepiece, hood, or helmet. (C) NIOSH-certified negative pressure (demand) supplied-air respirator with a full facepiece. (ii) Hazard communication. Requirements as specified in Sec. 721.72(a), (b), (c), (d), (e), (f)(concentration set at 1.0 percent), (g)(1)(The PMN substance may cause sensitization, eye irritation, internal organ effects, and developmental effects), (g)(2), (g)(3), (g)(4)(i), and (g)(5). (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(g) and (q). (iv) Release to water. (A) Requirements as specified in Sec. 721.90(a)(4), (b)(4), and (c)(4) N=6. However the requirements of Sec. 721.91(a)(4) do not apply. Instead, if control technologies are in place to treat the waste stream containing the PMN substance, the amount of the PMN substance reasonably likely to be removed from the waste stream by such treatment may be subtracted in calculating the number of kilograms releases. No more than 40 percent removal efficiency may be attributed to such treatment. (B) In lieu of calculating the quotient, monitoring or alternative calculations may be used to predict the surface water concentrations expected to result from the intended release of the substance, if the monitoring procedures or calculations have been approved for such purposes by EPA. (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) through (i), and (k) are applicable to manufacturers 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)(iii) of this section. 0 8. Add Sec. 721.10834 to subpart E to read as follows: Sec. 721.10834 Heteropolycyclic diacrylate (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as heteropolycyclic diacrylate (PMN P-14-20) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(2)(i), (a)(2)(iii), (a)(3), (a)(4), (a)(6)(i), (a)(6)(ii), (b) (concentration set at 1.0 percent), and (c). When determining which persons are reasonably likely to be exposed as required for Sec. 721.63(a)(4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. The following National Institute for Occupational Safety and Health (NIOSH)-certified respirators with an assigned protection factor (APF) of at least 10 meet the requirements of Sec. 721.63(a)(4): (A) NIOSH-certified power air-purifying respirator with a hood or helmet and with appropriate gas/vapor (acid gas, organic vapor, or substance specific) cartridges in combination with HEPA filters. (B) NIOSH-certified continuous flow supplied-air respirator equipped with a loose fitting facepiece, hood, or helmet. (ii) Release to water. Requirements as specified in Sec. 721.90(a)(4), (b)(4), and (c)(4) (N=120). (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) through (e), and (k) are applicable to manufacturers 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. 721.10835 to subpart E to read as follows: Sec. 721.10835 1,6-Hexanediamine, N1-(6-aminohexyl)-, polymer with 2- (chloromethyl)oxirane, N-(dithiocarboxy) derivs., sodium salts. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1,6-Hexanediamine, N1-(6-aminohexyl)-, polymer with 2-(chloromethyl)oxirane, N- (dithiocarboxy) derivs., sodium salts [[Page 32015]] (PMN P-14-66; CAS No. 1459738-70-5) 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) Release to water. Requirements as specified in Sec. 721.90(a)(4), (b)(4), and (c)(4) (N=1). (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) through (c), and (k) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 10. Add Sec. 721.10836 to subpart E to read as follows: Sec. 721.10836 Dimethylaminoalkyl alkene amide (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as dimethylaminoalkyl alkene amide (PMN P-14-209) 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) through (c), and (i) are applicable to manufacturers 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 11. Add Sec. 721.10837 to subpart E to read as follows: Sec. 721.10837 Substituted naphthalene polymer glycidyl ether (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as substituted naphthalene polymer glycidyl ether (PMN P-14-452) 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). (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) through (c), and (k) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 12. Add Sec. 721.10838 to subpart E to read as follows: Sec. 721.10838 Alkylpolycarboxylic acid, derivative, tris(fluorinatedalkoxy)alkyl ester salt (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkylpolycarboxylic acid, derivative, tris(fluorinatedalkoxy)alkyl ester salt (PMN P-14-473) 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=6). (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) through (c), and (k) are applicable to manufacturers 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. 721.10839 to subpart E to read as follows: Sec. 721.10839 Tricyclo[3.3.1.13,7]decan-1-amine, N,N-dimethyl-. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as tricyclo[3.3.1.13,7]decan-1-amine, N,N-dimethyl- (PMN P-14-476; CAS No. 3717-40-6) 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) Release to water. Requirements as specified in Sec. 721.90(a)(4), (b)(4), and (c)(4) (N=8). (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) through (c) and (k) are applicable to manufacturers 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. 721.10840 to subpart E to read as follows: Sec. 721.10840 Sulfosuccinic acid ester, alkylamine derivs., sodium salt (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as sulfosuccinic acid ester, alkylamine derivs., sodium salt (PMN P-14- 510) 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=94). (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) through (c), and (k) are applicable to manufacturers 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. 721.10841 to subpart E to read as follows: Sec. 721.10841 Bismuth nitrate oxide (Bi3(NO3)O4). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as bismuth nitrate oxide (Bi 3 (NO3 )O4 ) (PMN P-14-603; CAS No. 1417164-49-8) 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) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(4), (a)(6)(i), and (c). When determining which persons are reasonably likely to be exposed as required for Sec. 721.63(a)(4), engineering control measures (e.g., enclosure or confinement of the operation, general [[Page 32016]] and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. The following National Institute for Occupational Safety and Health (NIOSH)-certified respirator with an assigned protection factor (APF) of at least 10 meets the minimum requirements for Sec. 721.63(a)(4): NIOSH-certified air-purifying elastomeric half-mask respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters. (ii) Industrial commercial, and consumer activities. Requirements as specified in Sec. 721.80(j). (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) through (d), and (i) are applicable to manufacturers 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 16. Add Sec. 721.10842 to subpart E to read as follows: Sec. 721.10842 Substituted cyclosiloxane (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as substituted cyclosiloxane (PMN P-14-605) 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. A significant new use is any use other than as a refractive index modifier component for light-emitting diode (LED) chips. (ii) Release to water. Requirements as specified in Sec. 721.90(a)(1), (b)(1), and (c)(1). (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) through (c), (i), and (k) are applicable to manufacturers 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 Sec. 721.10843 to subpart E to read as follows: Sec. 721.10843 Substituted amide aromatic carboxylic acid, metal salt (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as substituted amide aromatic carboxylic acid, metal salt (PMNs P-14-666 and P-14-668) are 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) through (c), and (i) are applicable to manufacturers and processors of these substances. (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 18. Add Sec. 721.10844 to subpart E to read as follows: Sec. 721.10844 Graphene nanoplatelets having a predominant thickness of 1-10 layers with lateral dimension predominantly less than 2 microns. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as graphene nanoplatelets having a predominant thickness of 1-10 layers with lateral dimension predominantly less than 2 microns (PMN P-14-763) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the PMN substance that have been embedded or incorporated into a polymer matrix that itself has been reacted (cured); embedded in a permanent solid polymer form that is not intended to undergo further processing, except mechanical processing; or imported into an article as defined at 40 CFR 720.3(c). (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), (a)(6)(i), (a)(6)(ii), (b) (concentration set at 1.0 percent), and (c). When determining which persons are reasonably likely to be exposed as required for Sec. 721.63(a)(4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. The following National Institute for Occupational Safety and Health (NIOSH)-certified respirators meet the requirements of Sec. 721.63(a)(4): (A) NIOSH-certified power air-purifying, tight-fitting full-face respirator equipped with an N-100, P-100, or R-100 cartridge. (B) NIOSH-certified power air-purifying particulate respirator with an assigned protection factor (APF) of at least 50. (ii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(k), (q), and (y)(1). (iii) Release to water. Requirements as specified in Sec. 721.90(a)(1), (b)(1), and (c)(1). (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) through (e), (i), and (k) are applicable to manufacturers 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)(ii) of this section. 0 19. Add Sec. 721.10845 to subpart E to read as follows: Sec. 721.10845 Methanaminium, N-[4-[[4- (dimethylamino)phenyl]phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N- methyl-, ethanedioate, ethanedioate (2:2:1). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as methanaminium, N- [4-[[4-(dimethylamino)phenyl]phenylmethylene]-2,5-cyclohexadien-1- ylidene]-N-methyl-, ethanedioate, ethanedioate (2:2:1) (PMN P-14-781; CAS No. 2437-29-8) 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(f). [[Page 32017]] (ii) Release to water. Requirements as specified in Sec. 721.90(a)(4), (b)(4), and (c)(4) (N=1). (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) through (c), (i), and (k) are applicable to manufacturers 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 Sec. 721.10846 to subpart E to read as follows: Sec. 721.10846 Sulfurized hydrocarbon (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as sulfurized hydrocarbon (PMN P-14-811) 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. A significant new use is any use where less than 80 percent of the low molecular weight species are greater than 1,000 daltons. (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) through (c), and (i) are applicable to manufacturers 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 21. Add Sec. 721.10847 to subpart E to read as follows: Sec. 721.10847 Oxiranemethanaminium, N,N,N-trimethyl-, bromide. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as oxiranemethanaminium, N,N,N-trimethyl-, bromide (PMN P-14-821; CAS No. 13895-77-7) 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(v)(1), (w)(1), and (x)(1). (ii) Release to water. Requirements as specified in Sec. 721.90(a)(4), (b)(4), and (c)(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) through (c), (i), and (k) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 22. Add Sec. 721.10848 to subpart E to read as follows: Sec. 721.10848 Aryloxyalkyl amine (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as aryloxyalkyl amine (PMN P-14-875) 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=44). (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) through (c), and (k) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 23. Add Sec. 721.10849 to subpart E to read as follows: Sec. 721.10849 Phenol-biphenyl-formaldehyde polycondensate (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as phenol- biphenyl-formaldehyde polycondensate (PMN P-15-115) 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=5). (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) through (c), and (k) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 24. Add Sec. 721.10850 to subpart E to read as follows: Sec. 721.10850 Polymer of phenol, biphenyl and resorcinol (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polymer of phenol, biphenyl and resorcinol (PMN P-15-116) 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=5). (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) through (c), and (k) are applicable to manufacturers 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. 2015-13670 Filed 6-4-15; 8:45 am] BILLING CODE 6560-50-P
![Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Rules and Regulations 32003
TABLE ONE
Distance in
meters of forward
masthead light
Vessel No. below minimum
required height.
§ 2(a)(i) annex I
* * * * * * *
USS DETROIT ............................................................................................................................................... LCS 7 6.80
* * * * * * *
* * * * *
TABLE FIVE
After masthead
Masthead lights Forward masthead light less than Percentage
not over all light not in ⁄ ship’s length aft
12 horizontal
Vessel No. other lights forward quarter of forward separation
and obstructions. of ship. annex I, masthead light. attained
annex I, sec. 2(f) sec. 3(a) annex I, sec. 3(a)
* * * * * * *
USS DETROIT ............................. LCS 7 .................................. X X 23.0
* * * * * who intend to manufacture (including Do not submit electronically any
Approved: May 13, 2015. import) or process any of these 22 information you consider to be
A.B. Fischer,
chemical substances for an activity that Confidential Business Information (CBI)
is designated as a significant new use by or other information whose disclosure is
Captain, JAGC, U.S. Navy, Deputy Assistant
Judge Advocate, General (Admiralty and
this rule to notify EPA at least 90 days restricted by statute.
Maritime Law). before commencing that activity. The • Mail: Document Control Office
required notification will provide EPA (7407M), Office of Pollution Prevention
Dated: May 27, 2015.
with the opportunity to evaluate the and Toxics (OPPT), Environmental
P.A. Richelmi,
intended use and, if necessary, to
Lieutenant, Judge Advocate General’s Corps, Protection Agency, 1200 Pennsylvania
prohibit or limit that activity before it
U.S. Navy, Alternate Federal Register Liaison Ave. NW., Washington, DC 20460–0001.
occurs.
Officer. • Hand Delivery: To make special
[FR Doc. 2015–13754 Filed 6–4–15; 8:45 am] DATES: This rule is effective on August
arrangements for hand delivery or
4, 2015. For purposes of judicial review,
BILLING CODE 3810–FF–P delivery of boxed information, please
this rule shall be promulgated at 1 p.m.
(e.s.t.) on June 19, 2015. follow the instructions at http://
Written adverse or critical comments, www.epa.gov/dockets/contacts.html.
ENVIRONMENTAL PROTECTION or notice of intent to submit adverse or Additional instructions on
AGENCY critical comments, on one or more of commenting or visiting the docket,
these SNURs must be received on or along with more information about
40 CFR Parts 9 and 721
before July 6, 2015 (see Unit VI. of the dockets generally, is available at
[EPA–HQ–OPPT–2015–0220; FRL–9927–67] SUPPLEMENTARY INFORMATION). If EPA http://www.epa.gov/dockets.
receives written adverse or critical
RIN 2070–AB27 FOR FURTHER INFORMATION CONTACT:
comments, or notice of intent to submit
adverse or critical comments, on one or For technical information contact:
Significant New Use Rules on Certain Kenneth Moss, Chemical Control
Chemical Substances more of these SNURs before July 6,
2015, EPA will withdraw the relevant Division (7405M), Office of Pollution
AGENCY: Environmental Protection sections of this direct final rule before Prevention and Toxics, Environmental
Agency (EPA). its effective date. Protection Agency, 1200 Pennsylvania
ACTION: Direct final rule. For additional information on related Ave. NW., Washington, DC 20460–0001;
reporting requirement dates, see Units telephone number: (202) 564–9232;
SUMMARY: EPA is promulgating I.A., VI., and VII. of the SUPPLEMENTARY email address: moss.kenneth@epa.gov.
significant new use rules (SNURs) under INFORMATION. For general information contact: The
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the Toxic Substances Control Act ADDRESSES: Submit your comments, TSCA-Hotline, ABVI-Goodwill, 422
(TSCA) for 22 chemical substances identified by docket identification (ID) South Clinton Ave., Rochester, NY
which were the subject of number EPA–HQ–OPPT–2015–0220, by 14620; telephone number: (202) 554–
premanufacture notices (PMNs). Two of one of the following methods: 1404; email address: TSCA-Hotline@
these chemical substances are subject to • Federal eRulemaking Portal: http:// epa.gov.
TSCA section 5(e) consent orders issued www.regulations.gov. Follow the online
by EPA. This action requires persons instructions for submitting comments. SUPPLEMENTARY INFORMATION:
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![Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Rules and Regulations 32007
Basis for action: The PMN states that determined that the proposed PMN Number P–14–476
the generic (non-confidential) use of the manufacturing, processing, or use of the Chemical name:
substance will be as an adjuvant for substance may present an unreasonable Tricyclo[3.3.1.13,7]decan-1-amine, N,N-
non-Federal Insecticide, Fungicide, and risk. EPA has determined, however, that dimethyl-.
Rodenticide Act (FIFRA)-regulated any use of the substance resulting in CAS number: 3717–40–6.
agricultural use products, an additive surface water concentrations exceeding Basis for action: The PMN states that
for pesticide formulations, and an 1 ppb may cause significant adverse the generic (non-confidential) use of the
additive for fertilizer formulations. environmental effects. Based on this substance will be as an isolated
Based on test data on the PMN information, the PMN substance meets intermediate. Based on ecological SAR
substance, as well as ecological SAR the concern criteria at analysis of test data on analogous
analysis of test data on analogous § 721.170(b)(4)(ii). aliphatic amines, EPA predicts toxicity
amides and aliphatic amines, EPA to aquatic organisms may occur at
predicts chronic toxicity to aquatic Recommended testing: EPA has
determined that the results of a fish concentrations that exceed 8 ppb of the
organisms may occur at concentrations
early-life stage toxicity test (OPPTS Test PMN substance in surface waters. As
that exceed 4 ppb of the PMN substance
Guideline 850.1400); a daphnid chronic described in the PMN, releases of the
in surface waters for greater than 20
toxicity test (OPPTS Test Guideline substance are not expected to result in
days per year. This 20-day criterion is
850.1300); and an algal toxicity test surface water concentrations that exceed
derived from partial life cycle tests
(OCSPP Test Guideline 850.4500) would 8 ppb. Therefore, EPA has not
(daphnid chronic and fish early-life
help characterize the environmental determined that the proposed
stage tests) that typically range from 21
effects of the PMN substance. manufacturing, processing, or use of the
to 28 days in duration. EPA predicts
substance may present an unreasonable
toxicity to aquatic organisms may occur CFR citation: 40 CFR 721.10837.
if releases of the PMN substance to risk. EPA has determined that any use
surface water exceed releases from the PMN Number P–14–473 of the substance resulting in surface
use described in the PMN. For the uses water concentrations exceeding 8 ppb
Chemical name: Alkylpolycarboxylic may cause significant adverse
described in the PMN, environmental
releases did not exceed the acid, derivative, environmental effects. Based on this
concentration of concern for more than tris(fluorinatedalkoxy)alkyl ester salt information, the PMN substance meets
20 days per year. Therefore, EPA has not (generic). the concern criteria at
determined that the proposed CAS number: Claimed confidential. § 721.170(b)(4)(ii).
manufacturing, processing, or use of the Recommended testing: EPA has
Basis for action: The PMN states that determined that the results of a fish
substance may present an unreasonable the generic (non-confidential) use of the
risk. EPA has determined, however, that early-life stage toxicity test (OPPTS Test
substance will be for coatings and Guideline 850.1400); a daphnid chronic
use of the substance other than as printing applications. Based on
described in the PMN may cause toxicity test (OPPTS Test Guideline
ecological SAR analysis of test data on 850.1300); and an algal toxicity test
significant adverse environmental analogous anionic surfactants, EPA
effects. Based on this information, the (OCSPP Test Guideline 850.4500) would
predicts toxicity to aquatic organisms help characterize the environmental
PMN substances meet the concern may occur at concentrations that exceed
criteria at § 721.170(b)(4)(i) and effects of the PMN substance.
6 ppb of the PMN substance in surface CFR citation: 40 CFR 721.10839.
(b)(4)(ii). waters. As described in the PMN,
Recommended testing: EPA has PMN Number P–14–510
releases of the substance are not
determined that the results of a fish
early-life stage toxicity test (OPPTS Test expected to result in surface water Chemical name: Sulfosuccinic acid
Guideline 850.1400) and a daphnid concentrations that exceed 6 ppb. ester, alkylamine derivs., sodium salt
chronic toxicity test (OPPTS Test Therefore, EPA has not determined that (generic).
Guideline 850.1300) would help the proposed manufacturing, CAS number: Claimed confidential.
processing, or use of the substance may Basis for action: The PMN states that
characterize the environmental effects of
present an unreasonable risk. EPA has the generic (non-confidential) use of the
the PMN substance.
CFR citation: 40 CFR 721.10836. determined, however, that any use of substance will be as an industrial
the substance resulting in surface water leather softener. Based on test data on
PMN Number P–14–452 concentrations exceeding 6 ppb may the PMN substance as well as SAR
Chemical name: Substituted cause significant adverse environmental analysis of test data on analogous
naphthalene polymer glycidyl ether effects. Based on this information, the anionic surfactants, EPA predicts
(generic). PMN substance meets the concern toxicity to aquatic organisms may occur
CAS number: Claimed confidential. criteria at § 721.170(b)(4)(ii). at concentrations that exceed 94 ppb of
Basis for action: The PMN states that the PMN substance in surface waters. As
the generic (non-confidential) uses of Recommended testing: EPA has described in the PMN, releases of the
the substance will be as a matrix resin determined that the results of a water substance are not expected to result in
for composite materials and a binder solubility study (OECD Test Guideline surface water concentrations that exceed
resin for electronic materials. Based on 105); a fish acute toxicity test, 94 ppb. Therefore, EPA has not
ecological SAR analysis of test data on freshwater and marine (OPPTS Test determined that the proposed
analogous polyepoxides, EPA predicts Guideline 850.1075); a fish early-life manufacturing, processing, or use of the
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toxicity to aquatic organisms may occur stage toxicity test (OPPTS Test substance may present an unreasonable
at concentrations that exceed 1 ppb of Guideline 850.1400); and a daphnid risk. EPA has determined, however, that
the PMN substance in surface waters. As chronic toxicity test (OPPTS Test any use of the substance resulting in
described in the PMN, releases of the Guideline 850.1300) would help surface water concentrations exceeding
substance are not expected to result in characterize the environmental effects of 94 ppb may cause significant adverse
surface water concentrations that exceed the PMN substance. environmental effects. Based on this
1 ppb. Therefore, EPA has not CFR citation: 40 CFR 721.10838. information, the PMN substance meets
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![Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Rules and Regulations 32009
of the PMN substances specified in the significant adverse environmental sediment (OECD Test Guideline 218); a
consent order. effects. Based on this information, the fish early-life stage toxicity test (OPPTS
6. No predictable or purposeful PMN substance meets the concern Test Guideline 850.1400); a daphnid
release of the PMN substances from criteria at § 721.170(b)(3)(ii) and chronic toxicity test (OPPTS Test
manufacturing, processing or use into (b)(4)(ii). Guideline 850.1300); and an algal
the waters of the United States. Recommended testing: EPA has toxicity test (OCSPP Test Guideline
The SNUR designates as a ‘‘significant determined that the results of a 850.4500) would help characterize the
new use’’ the absence of these protective combined repeated dose toxicity with environmental effects of the PMN
measures. the reproduction/developmental substance.
Recommended testing: EPA has toxicity screening test (OECD Test CFR citation: 40 CFR 721.10846.
determined that the results of certain Guideline 422); a bacterial reverse
particle size distribution and material PMN Number P–14–821
mutation test (OECD Test Guideline
characterization testing would be 471); an in vitro mammalian Chemical name:
needed for the PMN substance. The chromosome aberration test (OECD Test Oxiranemethanaminium, N,N,N-
company has agreed to submit the full Guideline 473); a fish acute toxicity test, trimethyl-, bromide.
chemical characterization testing freshwater and marine (OPPTS Test CAS number: 13895–77–7.
described in the testing section of the Guideline 850.1075); an aquatic Basis for action: The PMN states that
consent order within the timeframes invertebrate acute toxicity test (OPPTS the substance will be used as an
identified in the order. Further, Test Guideline 850.1010); and an algal intermediate for polymer production.
depending on the results of the toxicity test (OCSPP Test Guideline Based on test data on analogous
characterization testing, additional 850.4500) would help characterize the epoxides, EPA identified concerns for
toxicity testing may be required at a human health an environmental effects skin and lung sensitization,
confidential aggregate manufacture of the PMN substance. mutagenicity, oncogenicity,
volume, as detailed in the consent CFR citation: 40 CFR 721.10845. developmental toxicity, male
order. reproductive, liver, and kidney toxicity
CFR citation: 40 CFR 721.10844. PMN Number P–14–811 from dermal and inhalation exposures.
Chemical name: Sulfurized Further, based on ecological SAR
PMN Number P–14–781 hydrocarbon (generic). analysis of test data on analogous
Chemical name: Methanaminium, N- CAS number: Claimed confidential. quaternary ammonium compounds,
[4-[[4-(dimethylamino)phenyl] Basis for action: The PMN states that EPA predicts toxicity to aquatic
phenylmethylene]-2,5-cyclohexadien-1- the use of the substance will be as a organisms may occur at concentrations
ylidene]-N-methyl-, ethanedioate, lubricant additive. Based on ecological that exceed 28 ppb of the PMN
ethanedioate (2:2:1). SAR analysis of test data on analogous substance in surface waters. As
CAS number: 2437–29–8. neutral organics, EPA predicts toxicity described in the PMN, particulate
Basis for action: The PMN states that to aquatic organisms may occur at exposures are not expected and releases
the generic (non-confidential) use of the concentrations that exceed 1 ppb of the of the substance are not expected to
substance will be as a component of low molecular weight components of result in surface water concentrations
industrial inks and dyes. Based on test PMN substance in surface waters. As that exceed 28 ppb. Therefore, EPA has
data on analogous malachite green described in the PMN, where 80 percent not determined that the proposed
chloride, pararosaniline, gentian violet, of the molecular weight species is manufacturing, processing, or use of the
crystal violet, oxalic acid, and other greater than 1,000 daltons, releases of substance may present an unreasonable
analogous substances, EPA identified the substance are not expected to result risk. EPA has determined, however, that
concerns for mutagenicity, in surface water concentrations that any manufacture, processing, or use of
carcinogenicity, eye irritation, as well as exceed 1 ppb of the low molecular the substance in the form of a powder
kidney, acute, and developmental weight components. Therefore, EPA has or any use of the substance resulting in
toxicities for occupational inhalation not determined that the proposed surface water concentrations exceeding
exposures and general population manufacturing, processing, or use of the 28 ppb may cause serious health effects
exposures from drinking water substance may present an unreasonable and significant adverse environmental
exposures. In addition, based on risk. EPA has determined, however, that effects. Based on this information, the
ecological SAR analysis of test data on any use of the substance where less than PMN substance meets the concern
analogous cationic dyes, EPA predicts 80 percent of the molecular weight criteria at § 721.170(b)(3)(ii) and
toxicity to aquatic organisms may occur species is greater than 1,000 daltons, (b)(4)(ii).
at concentrations that exceed 1 ppb of may cause significant adverse Recommended testing: EPA has
the PMN substance in surface waters. As environmental effects. Based on this determined that the results of a 90-day
described in the PMN, occupational information, the PMN substance meets inhalation toxicity test (OPPTS Test
exposures during processing and use the concern criteria at Guideline 870.3465); a bacterial reverse
activities are expected to be minimal. § 721.170(b)(4)(ii). mutation test (OPPTS Test Guideline
Further, releases of the PMN substance Recommended testing: EPA has 870.5100); a ready biodegradability test
are not expected to result in surface determined that the results of an (OECD Test Guideline 301D) closed
water concentrations that exceed 1 ppb. inherent biodegradability Zahn-Wellens bottle method; a fish early-life stage
Therefore, EPA has not determined that test (OECD Test Guideline 302); an toxicity test (OPPTS Test Guideline
the proposed processing or use of the aerobic and anaerobic transformation in 850.1400); a daphnid chronic toxicity
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substance may present an unreasonable soil test (OECD Test Guideline 307); a test (OPPTS Test Guideline 850.1300);
risk. EPA has determined, however, that fish BCF test: Aqueous and dietary and an algal toxicity test (OCSPP Test
any domestic manufacture of the exposure (OECD Test Guideline 305); a Guideline 850.4500) would help
substance, or any release of the bioaccumulation in sediment-dwelling characterize the human health and
substance resulting in surface water benthic oligochaetes test (OECD Test environmental effects of the PMN
concentrations exceeding 1 ppb may Guideline 315); a sediment-water substance.
cause serious health effects and chironomid toxicity test using spiked CFR citation: 40 CFR 721.10847.
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Significantly Affect Energy Supply, 6901–6992k, 7401–7671q, 7542, 9601–9657, (i) Industrial, commercial, and
Distribution, or Use’’ (66 FR 28355, May 11023, 11048. consumer activities. Requirements as
22, 2001), because this action is not specified in § 721.80(f), (j), and (o).
■ 2. In § 9.1, add the following sections
expected to affect energy supply, (ii) [Reserved]
in numerical order under the (b) Specific requirements. The
distribution, or use and because this
undesignated center heading provisions of subpart A of this part
action is not a significant regulatory
‘‘Significant New Uses of Chemical apply to this section except as modified
action under Executive Order 12866.
Substances’’ to read as follows: by this paragraph.
I. National Technology Transfer and (1) Recordkeeping. Recordkeeping
§ 9.1 OMB approvals under the Paperwork
Advancement Act (NTTAA) requirements as specified in
Reduction Act.
In addition, since this action does not * * * * * § 721.125(a) through (c), and (i) are
involve any technical standards, applicable to manufacturers and
NTTAA section 12(d) (15 U.S.C. 272 OMB control processors of this substance.
40 CFR citation (2) Limitations or revocation of
note), does not apply to this action. No.
certain notification requirements. The
J. Executive Order 12898 provisions of § 721.185 apply to this
* * * * * section.
This action does not entail special
considerations of environmental justice Significant New Uses of Chemical ■ 5. Add § 721.10831 to subpart E to
related issues as delineated by Substances read as follows:
Executive Order 12898, entitled
‘‘Federal Actions to Address § 721.18031 Aluminum phosphate
* * * * * (generic).
Environmental Justice in Minority
Populations and Low-Income (a) Chemical substance and
Populations’’ (59 FR 7629, February 16, 721.10830 ................................. 2070–0012 significant new uses subject to reporting.
721.10831 ................................. 2070–0012 (1) The chemical substance identified
1994). 721.10832 ................................. 2070–0012 generically as aluminum phosphate
XIII. Congressional Review Act 721.10833 ................................. 2070–0012 (PMN P–13–690) is subject to reporting
721.10834 ................................. 2070–0012
Pursuant to the Congressional Review 721.10835 ................................. 2070–0012
under this section for the significant
Act (5 U.S.C. 801 et seq.), EPA will 721.10836 ................................. 2070–0012 new uses described in paragraph (a)(2)
submit a report containing this rule and 721.10837 ................................. 2070–0012 of this section. The requirements of this
other required information to the U.S. 721.10838 ................................. 2070–0012 section do not apply to quantities of the
Senate, the U.S. House of 721.10839 ................................. 2070–0012 PMN substance that has been
Representatives, and the Comptroller 721.10840 ................................. 2070–0012 completely reacted (cured) or entrained
721.10841 ................................. 2070–0012 into a polymer matrix.
General of the United States prior to 721.10842 ................................. 2070–0012
publication of the rule in the Federal (2) The significant new uses are:
721.10843 ................................. 2070–0012 (i) Protection in the workplace.
Register. This action is not a ‘‘major 721.10844 ................................. 2070–0012
rule’’ as defined by 5 U.S.C. 804(2). Requirements as specified in
721.10845 ................................. 2070–0012
721.10846 ................................. 2070–0012
§ 721.63(a)(4) and (a)(6)(1). When
List of Subjects 721.10847 ................................. 2070–0012 determining which persons are
40 CFR Part 9 721.10848 ................................. 2070–0012 reasonably likely to be exposed as
721.10849 ................................. 2070–0012 required for § 721.63(a)(4), engineering
Environmental protection, Reporting 721.10850 ................................. 2070–0012 control measures (e.g., enclosure or
and recordkeeping requirements. confinement of the operation, general
40 CFR Part 721 and local ventilation) or administrative
* * * * * control measures (e.g., workplace
Environmental protection, Chemicals, policies and procedures) shall be
Hazardous substances, Reporting and * * * * * considered and implemented to prevent
recordkeeping requirements. exposure, where feasible. A National
PART 721—[AMENDED]
Dated: May 28, 2015. Institute for Occupational Safety and
Maria J. Doa, Health (NIOSH)-certified respirator with
■ 3. The authority citation for part 721
Director, Chemical Control Division, Office an Assigned Protection Factor (APF) of
continues to read as follows:
of Pollution Prevention and Toxics. at least 10 meet the requirements of
Authority: 15 U.S.C. 2604, 2607, and § 721.63(a)(4).
Therefore, 40 CFR parts 9 and 721 are 2625(c). (ii) Release to water. Requirements as
amended as follows: specified in § 721.90(a)(4), (b)(4), and
■ 4. Add § 721.10830 to subpart E to (c)(4) (N=87).
PART 9—[AMENDED] read as follows: (b) Specific requirements. The
§ 721.18030 2-Butene, 1,1,1,4,4,4- provisions of subpart A of this part
■ 1. The authority citation for part 9
hexafluoro-, (2Z)-. apply to this section except as modified
continues to read as follows:
by this paragraph.
Authority: 7 U.S.C. 135 et seq., 136–136y; (a) Chemical substance and (1) Recordkeeping. Recordkeeping
15 U.S.C. 2001, 2003, 2005, 2006, 2601–2671; significant new uses subject to reporting. requirements as specified in
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21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 (1) The chemical substance identified as § 721.125(a) through (e), and (k) are
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 2-butene, 1,1,1,4,4,4-hexafluoro-, (2Z)- applicable to manufacturers and
1321, 1326, 1330, 1342, 1344, 1345(d) and (PMN P–11–549; CAS No. 692–49–9) is
(e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, processors of this substance.
subject to reporting under this section (2) Limitations or revocation of
1971–1975 Comp. p. 973; 42 U.S.C. 241, for the significant new uses described in
242b, 243, 246, 300f, 300g, 300g–1, 300g–2, certain notification requirements. The
300g–3, 300g–4, 300g–5, 300g–6, 300j–1,
paragraph (a)(2) of this section. provisions of § 721.185 apply to this
300j–2, 300j–3, 300j–4, 300j–9, 1857 et seq., (2) The significant new uses are: section.
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■ 6. Add § 721.10832 to subpart E to (A) NIOSH-certified power air- § 721.10834 Heteropolycyclic diacrylate
read as follows: purifying respirator with a hood or (generic).
helmet and with appropriate gas/vapor (a) Chemical substance and
§ 721.10832 Alkyl triazine (generic). (acid gas, organic vapor, or substance significant new uses subject to reporting.
(a) Chemical substance and specific) cartridges in combination with (1) The chemical substance identified
significant new uses subject to reporting. HEPA filters. generically as heteropolycyclic
(1) The chemical substance identified diacrylate (PMN P–14–20) is subject to
(B) NIOSH-certified continuous flow
generically as alkyl triazine (PMN P–13– reporting under this section for the
supplied-air respirator equipped with a
872) is subject to reporting under this significant new uses described in
loose fitting facepiece, hood, or helmet.
section for the significant new uses paragraph (a)(2) of this section.
described in paragraph (a)(2) of this (C) NIOSH-certified negative pressure (2) The significant new uses are:
section. (demand) supplied-air respirator with a (i) Protection in the workplace.
(2) The significant new uses are: full facepiece. Requirements as specified in
(i) Release to water. Requirements as (ii) Hazard communication. § 721.63(a)(1), (a)(2)(i), (a)(2)(iii), (a)(3),
specified in § 721.90(a)(4), (b)(4), and Requirements as specified in (a)(4), (a)(6)(i), (a)(6)(ii), (b)
(c)(4) (N=130). § 721.72(a), (b), (c), (d), (e), (concentration set at 1.0 percent), and
(ii) [Reserved] (f)(concentration set at 1.0 percent), (c). When determining which persons
(b) Specific requirements. The (g)(1)(The PMN substance may cause are reasonably likely to be exposed as
provisions of subpart A of this part sensitization, eye irritation, internal required for § 721.63(a)(4), engineering
apply to this section except as modified organ effects, and developmental control measures (e.g., enclosure or
by this paragraph. effects), (g)(2), (g)(3), (g)(4)(i), and (g)(5). confinement of the operation, general
(1) Recordkeeping. Recordkeeping and local ventilation) or administrative
requirements as specified in (iii) Industrial, commercial, and
consumer activities. Requirements as control measures (e.g., workplace
§ 721.125(a) through (c), and (k) are policies and procedures) shall be
applicable to manufacturers and specified in § 721.80(g) and (q).
considered and implemented to prevent
processors of this substance. (iv) Release to water. (A)
exposure, where feasible. The following
(2) Limitations or revocation of Requirements as specified in
National Institute for Occupational
certain notification requirements. The § 721.90(a)(4), (b)(4), and (c)(4) N=6.
Safety and Health (NIOSH)-certified
provisions of § 721.185 apply to this However the requirements of
respirators with an assigned protection
section. § 721.91(a)(4) do not apply. Instead, if
factor (APF) of at least 10 meet the
■ 7. Add § 721.10833 to subpart E to control technologies are in place to treat
requirements of § 721.63(a)(4):
read as follows: the waste stream containing the PMN (A) NIOSH-certified power air-
substance, the amount of the PMN purifying respirator with a hood or
§ 721.10833 Substituted bis 2,6-xylenol substance reasonably likely to be
(generic). helmet and with appropriate gas/vapor
removed from the waste stream by such (acid gas, organic vapor, or substance
(a) Chemical substance and treatment may be subtracted in specific) cartridges in combination with
significant new uses subject to reporting. calculating the number of kilograms HEPA filters.
(1) The chemical substance identified releases. No more than 40 percent (B) NIOSH-certified continuous flow
generically as substituted bis 2,6- removal efficiency may be attributed to supplied-air respirator equipped with a
xylenol (PMN P–13–930) is subject to such treatment. loose fitting facepiece, hood, or helmet.
reporting under this section for the (B) In lieu of calculating the quotient, (ii) Release to water. Requirements as
significant new uses described in monitoring or alternative calculations specified in § 721.90(a)(4), (b)(4), and
paragraph (a)(2) of this section. The may be used to predict the surface water (c)(4) (N=120).
requirements of this section do not concentrations expected to result from (b) Specific requirements. The
apply to quantities of the PMN the intended release of the substance, if provisions of subpart A of this part
substance that have been incorporated the monitoring procedures or apply to this section except as modified
into an article or has been incorporated calculations have been approved for by this paragraph.
into a polymer matrix. such purposes by EPA. (1) Recordkeeping. Recordkeeping
(2) The significant new uses are: requirements as specified in
(i) Protection in the workplace. (b) Specific requirements. The
provisions of subpart A of this part § 721.125(a) through (e), and (k) are
Requirements as specified in applicable to manufacturers and
§ 721.63(a)(1), (a)(2)(i), (a)(3), (a)(4), apply to this section except as modified
by this paragraph. processors of this substance.
(a)(6)(i), (a)(6)(ii), (b)(concentration set (2) Limitations or revocation of
at 1.0 percent), and (c). When (1) Recordkeeping. Recordkeeping certain notification requirements. The
determining which persons are requirements as specified in provisions of § 721.185 apply to this
reasonably likely to be exposed as § 721.125(a) through (i), and (k) are section.
required for § 721.63(a)(4), engineering applicable to manufacturers and
■ 9. Add § 721.10835 to subpart E to
control measures (e.g., enclosure or processors of this substance.
read as follows:
confinement of the operation, general (2) Limitations or revocation of
and local ventilation) or administrative certain notification requirements. The § 721.10835 1,6-Hexanediamine, N1-(6-
control measures (e.g., workplace provisions of § 721.185 apply to this aminohexyl)-, polymer with 2-
policies and procedures) shall be section. (chloromethyl)oxirane, N-(dithiocarboxy)
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considered and implemented to prevent derivs., sodium salts.
(3) Determining whether a specific use
exposure, where feasible. The following (a) Chemical substance and
is subject to this section. The provisions
National Institute for Occupational significant new uses subject to reporting.
of § 721.1725(b)(1) apply to paragraph
Safety and Health (NIOSH)-certified (1) The chemical substance identified as
(a)(2)(iii) of this section.
respirators with an assigned protection 1,6-Hexanediamine, N1-(6-aminohexyl)-
factor (APF) of at least 50 meet the ■ 8. Add § 721.10834 to subpart E to , polymer with 2-(chloromethyl)oxirane,
requirements of § 721.63(a)(4): read as follows: N-(dithiocarboxy) derivs., sodium salts
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(PMN P–14–66; CAS No. 1459738–70–5) (2) The significant new uses are: (ii) [Reserved]
is subject to reporting under this section (i) Release to water. Requirements as (b) Specific requirements. The
for the significant new uses described in specified in § 721.90(a)(4), (b)(4), and provisions of subpart A of this part
paragraph (a)(2) of this section. (c)(4) (N=1). apply to this section except as modified
(2) The significant new uses are: (ii) [Reserved] by this paragraph.
(i) Release to water. Requirements as (b) Specific requirements. The (1) Recordkeeping. Recordkeeping
specified in § 721.90(a)(4), (b)(4), and provisions of subpart A of this part requirements as specified in
(c)(4) (N=1). apply to this section except as modified § 721.125(a) through (c) and (k) are
(ii) [Reserved] by this paragraph. applicable to manufacturers and
(b) Specific requirements. The (1) Recordkeeping. Recordkeeping processors of this substance.
provisions of subpart A of this part requirements as specified in (2) Limitations or revocation of
apply to this section except as modified § 721.125(a) through (c), and (k) are certain notification requirements. The
by this paragraph. applicable to manufacturers and provisions of § 721.185 apply to this
(1) Recordkeeping. Recordkeeping processors of this substance. section.
requirements as specified in (2) Limitations or revocation of ■ 14. Add § 721.10840 to subpart E to
§ 721.125(a) through (c), and (k) are certain notification requirements. The
applicable to manufacturers and read as follows:
provisions of § 721.185 apply to this
processors of this substance. section. § 721.10840 Sulfosuccinic acid ester,
(2) Limitations or revocation of alkylamine derivs., sodium salt (generic).
■ 12. Add § 721.10838 to subpart E to
certain notification requirements. The (a) Chemical substance and
provisions of § 721.185 apply to this read as follows:
significant new uses subject to reporting.
section. § 721.10838 Alkylpolycarboxylic acid, (1) The chemical substance identified
■ 10. Add § 721.10836 to subpart E to derivative, tris(fluorinatedalkoxy)alkyl ester generically as sulfosuccinic acid ester,
read as follows: salt (generic). alkylamine derivs., sodium salt (PMN
(a) Chemical substance and P–14–510) is subject to reporting under
§ 721.10836 Dimethylaminoalkyl alkene
amide (generic). significant new uses subject to reporting. this section for the significant new uses
(1) The chemical substance identified described in paragraph (a)(2) of this
(a) Chemical substance and
generically as alkylpolycarboxylic acid, section.
significant new uses subject to reporting.
derivative, tris(fluorinatedalkoxy)alkyl (2) The significant new uses are:
(1) The chemical substance identified
ester salt (PMN P–14–473) is subject to (i) Release to water. Requirements as
generically as dimethylaminoalkyl
reporting under this section for the specified in § 721.90(a)(4), (b)(4), and
alkene amide (PMN P–14–209) is
significant new uses described in (c)(4) (N=94).
subject to reporting under this section
paragraph (a)(2) of this section. (ii) [Reserved]
for the significant new uses described in
(2) The significant new uses are: (b) Specific requirements. The
paragraph (a)(2) of this section.
(2) The significant new uses are: (i) Release to water. Requirements as provisions of subpart A of this part
(i) Industrial, commercial, and specified in § 721.90(a)(4), (b)(4), and apply to this section except as modified
consumer activities. Requirements as (c)(4) (N=6). by this paragraph.
specified in § 721.80(j). (ii) [Reserved] (1) Recordkeeping. Recordkeeping
(ii) [Reserved] (b) Specific requirements. The requirements as specified in
(b) Specific requirements. The provisions of subpart A of this part § 721.125(a) through (c), and (k) are
provisions of subpart A of this part apply to this section except as modified applicable to manufacturers and
apply to this section except as modified by this paragraph. processors of this substance.
by this paragraph. (1) Recordkeeping. Recordkeeping (2) Limitations or revocation of
(1) Recordkeeping. Recordkeeping requirements as specified in certain notification requirements. The
requirements as specified in § 721.125(a) through (c), and (k) are provisions of § 721.185 apply to this
§ 721.125(a) through (c), and (i) are applicable to manufacturers and section.
applicable to manufacturers and processors of this substance. ■ 15. Add § 721.10841 to subpart E to
processors of this substance. (2) Limitations or revocation of read as follows:
(2) Limitations or revocation of certain notification requirements. The
certain notification requirements. The provisions of § 721.185 apply to this § 721.10841 Bismuth nitrate oxide
section. (Bi3(NO3)O4).
provisions of § 721.185 apply to this
section. ■ 13. Add § 721.10839 to subpart E to (a) Chemical substance and
(3) Determining whether a specific use read as follows: significant new uses subject to reporting.
is subject to this section. The provisions (1) The chemical substance identified as
of § 721.1725(b)(1) apply to paragraph § 721.10839 Tricyclo[3.3.1.13,7]decan-1- bismuth nitrate oxide (Bi3(NO3)O4)
(a)(2)(i) of this section. amine, N,N-dimethyl-. (PMN P–14–603; CAS No. 1417164–49–
■ 11. Add § 721.10837 to subpart E to (a) Chemical substance and 8) is subject to reporting under this
read as follows: significant new uses subject to reporting. section for the significant new uses
(1) The chemical substance identified as described in paragraph (a)(2) of this
§ 721.10837 Substituted naphthalene tricyclo[3.3.1.13,7]decan-1-amine, N,N- section.
polymer glycidyl ether (generic). dimethyl- (PMN P–14–476; CAS No. (2) The significant new uses are:
(a) Chemical substance and 3717–40–6) is subject to reporting under (i) Protection in the workplace.
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significant new uses subject to reporting. this section for the significant new uses Requirements as specified in
(1) The chemical substance identified described in paragraph (a)(2) of this § 721.63(a)(4), (a)(6)(i), and (c). When
generically as substituted naphthalene section. determining which persons are
polymer glycidyl ether (PMN P–14–452) (2) The significant new uses are: reasonably likely to be exposed as
is subject to reporting under this section (i) Release to water. Requirements as required for § 721.63(a)(4), engineering
for the significant new uses described in specified in § 721.90(a)(4), (b)(4), and control measures (e.g., enclosure or
paragraph (a)(2) of this section. (c)(4) (N=8). confinement of the operation, general
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and local ventilation) or administrative ■ 17. Add § 721.10843 to subpart E to (c). When determining which persons
control measures (e.g., workplace read as follows: are reasonably likely to be exposed as
policies and procedures) shall be required for § 721.63(a)(4), engineering
considered and implemented to prevent § 721.10843 Substituted amide aromatic control measures (e.g., enclosure or
carboxylic acid, metal salt (generic).
exposure, where feasible. The following confinement of the operation, general
National Institute for Occupational (a) Chemical substance and and local ventilation) or administrative
Safety and Health (NIOSH)-certified significant new uses subject to reporting. control measures (e.g., workplace
respirator with an assigned protection (1) The chemical substances identified policies and procedures) shall be
factor (APF) of at least 10 meets the generically as substituted amide considered and implemented to prevent
minimum requirements for aromatic carboxylic acid, metal salt exposure, where feasible. The following
§ 721.63(a)(4): NIOSH-certified air- (PMNs P–14–666 and P–14–668) are National Institute for Occupational
purifying elastomeric half-mask subject to reporting under this section Safety and Health (NIOSH)-certified
respirator equipped with N100 (if oil for the significant new uses described in respirators meet the requirements of
aerosols absent), R100, or P100 filters. paragraph (a)(2) of this section. § 721.63(a)(4):
(ii) Industrial commercial, and (2) The significant new uses are: (A) NIOSH-certified power air-
consumer activities. Requirements as (i) Industrial commercial, and purifying, tight-fitting full-face
specified in § 721.80(j). consumer activities. Requirements as respirator equipped with an N–100, P–
(b) Specific requirements. The specified in § 721.80(j). 100, or R–100 cartridge.
provisions of subpart A of this part (ii) [Reserved]
(B) NIOSH-certified power air-
apply to this section except as modified (b) Specific requirements. The
purifying particulate respirator with an
by this paragraph. provisions of subpart A of this part
assigned protection factor (APF) of at
(1) Recordkeeping. Recordkeeping apply to this section except as modified
least 50.
requirements as specified in by this paragraph.
(1) Recordkeeping. Recordkeeping (ii) Industrial, commercial, and
§ 721.125(a) through (d), and (i) are consumer activities. Requirements as
applicable to manufacturers and requirements as specified in
§ 721.125(a) through (c), and (i) are specified in § 721.80(k), (q), and (y)(1).
processors of this substance. (iii) Release to water. Requirements as
(2) Limitations or revocation of applicable to manufacturers and
processors of these substances. specified in § 721.90(a)(1), (b)(1), and
certain notification requirements. The (c)(1).
provisions of § 721.185 apply to this (2) Limitations or revocation of
certain notification requirements. The (b) Specific requirements. The
section.
provisions of § 721.185 apply to this provisions of subpart A of this part
(3) Determining whether a specific use
section. apply to this section except as modified
is subject to this section. The provisions
(3) Determining whether a specific use by this paragraph.
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section. is subject to this section. The provisions (1) Recordkeeping. Recordkeeping
of § 721.1725(b)(1) apply to paragraph requirements as specified in
■ 16. Add § 721.10842 to subpart E to
(a)(2)(i) of this section. § 721.125(a) through (e), (i), and (k) are
read as follows: applicable to manufacturers and
■ 18. Add § 721.10844 to subpart E to
§ 721.10842 Substituted cyclosiloxane processors of this substance.
read as follows:
(generic). (2) Limitations or revocation of
(a) Chemical substance and § 721.10844 Graphene nanoplatelets certain notification requirements. The
significant new uses subject to reporting. having a predominant thickness of 1–10 provisions of § 721.185 apply to this
(1) The chemical substance identified layers with lateral dimension predominantly section.
less than 2 microns. (3) Determining whether a specific use
generically as substituted cyclosiloxane
(PMN P–14–605) is subject to reporting (a) Chemical substance and is subject to this section. The provisions
under this section for the significant significant new uses subject to reporting. of § 721.1725(b)(1) apply to paragraph
new uses described in paragraph (a)(2) (1) The chemical substance identified as (a)(2)(ii) of this section.
of this section. graphene nanoplatelets having a ■ 19. Add § 721.10845 to subpart E to
(2) The significant new uses are: predominant thickness of 1–10 layers read as follows:
(i) Industrial commercial, and with lateral dimension predominantly
consumer activities. A significant new less than 2 microns (PMN P–14–763) is § 721.10845 Methanaminium, N-[4-[[4-
use is any use other than as a refractive subject to reporting under this section (dimethylamino)phenyl]phenylmethylene]-
for the significant new uses described in 2,5-cyclohexadien-1-ylidene]-N-methyl-,
index modifier component for light-
paragraph (a)(2) of this section. The ethanedioate, ethanedioate (2:2:1).
emitting diode (LED) chips.
(ii) Release to water. Requirements as requirements of this section do not (a) Chemical substance and
specified in § 721.90(a)(1), (b)(1), and apply to quantities of the PMN significant new uses subject to reporting.
(c)(1). substance that have been embedded or (1) The chemical substance identified as
(b) Specific requirements. The incorporated into a polymer matrix that methanaminium, N-[4-[[4-
provisions of subpart A of this part itself has been reacted (cured); (dimethylamino)phenyl
apply to this section except as modified embedded in a permanent solid polymer ]phenylmethylene]-2,5-cyclohexadien-1-
by this paragraph. form that is not intended to undergo ylidene]-N-methyl-, ethanedioate,
(1) Recordkeeping. Recordkeeping further processing, except mechanical ethanedioate (2:2:1) (PMN P–14–781;
requirements as specified in processing; or imported into an article CAS No. 2437–29–8) is subject to
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§ 721.125(a) through (c), (i), and (k) are as defined at 40 CFR 720.3(c). reporting under this section for the
applicable to manufacturers and (2) The significant new uses are: significant new uses described in
processors of this substance. (i) Protection in the workplace. paragraph (a)(2) of this section.
(2) Limitations or revocation of Requirements as specified in (2) The significant new uses are:
certain notification requirements. The § 721.63(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (i) Industrial commercial, and
provisions of § 721.185 apply to this (a)(4), (a)(6)(i), (a)(6)(ii), (b) consumer activities. Requirements as
section. (concentration set at 1.0 percent), and specified in § 721.80(f).
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![Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Rules and Regulations 32017
(ii) Release to water. Requirements as (i) Industrial commercial, and (b) Specific requirements. The
specified in § 721.90(a)(4), (b)(4), and consumer activities. Requirements as provisions of subpart A of this part
(c)(4) (N=1). specified in § 721.80(v)(1), (w)(1), and apply to this section except as modified
(b) Specific requirements. The (x)(1). by this paragraph.
provisions of subpart A of this part (ii) Release to water. Requirements as (1) Recordkeeping. Recordkeeping
apply to this section except as modified specified in § 721.90(a)(4), (b)(4), and requirements as specified in
by this paragraph. (c)(4) (N=28). § 721.125(a) through (c), and (k) are
(1) Recordkeeping. Recordkeeping (b) Specific requirements. The applicable to manufacturers and
requirements as specified in provisions of subpart A of this part processors of this substance.
§ 721.125(a) through (c), (i), and (k) are apply to this section except as modified (2) Limitations or revocation of
applicable to manufacturers and by this paragraph. certain notification requirements. The
processors of this substance. (1) Recordkeeping. Recordkeeping provisions of § 721.185 apply to this
(2) Limitations or revocation of requirements as specified in section.
certain notification requirements. The § 721.125(a) through (c), (i), and (k) are ■ 24. Add § 721.10850 to subpart E to
provisions of § 721.185 apply to this applicable to manufacturers and read as follows:
section. processors of this substance.
■ 20. Add § 721.10846 to subpart E to (2) Limitations or revocation of § 721.10850 Polymer of phenol, biphenyl
certain notification requirements. The and resorcinol (generic).
read as follows:
provisions of § 721.185 apply to this (a) Chemical substance and
§ 721.10846 Sulfurized hydrocarbon section. significant new uses subject to reporting.
(generic). (1) The chemical substance identified
■ 22. Add § 721.10848 to subpart E to
(a) Chemical substance and read as follows: generically as polymer of phenol,
significant new uses subject to reporting. biphenyl and resorcinol (PMN P–15–
(1) The chemical substance identified § 721.10848 Aryloxyalkyl amine (generic). 116) is subject to reporting under this
generically as sulfurized hydrocarbon (a) Chemical substance and section for the significant new uses
(PMN P–14–811) is subject to reporting significant new uses subject to reporting. described in paragraph (a)(2) of this
under this section for the significant (1) The chemical substance identified section.
new uses described in paragraph (a)(2) generically as aryloxyalkyl amine (PMN (2) The significant new uses are:
of this section. P–14–875) is subject to reporting under (i) Release to water. Requirements as
(2) The significant new uses are: this section for the significant new uses specified in § 721.90(a)(4), (b)(4), and
(i) Industrial commercial, and described in paragraph (a)(2) of this (c)(4) (N=5).
consumer activities. Requirements as section. (ii) [Reserved]
specified in § 721.80. A significant new (2) The significant new uses are: (b) Specific requirements. The
use is any use where less than 80 (i) Release to water. Requirements as provisions of subpart A of this part
percent of the low molecular weight specified in § 721.90(a)(4), (b)(4), and apply to this section except as modified
species are greater than 1,000 daltons. (c)(4) (N=44). by this paragraph.
(ii) [Reserved] (ii) [Reserved] (1) Recordkeeping. Recordkeeping
(b) Specific requirements. The (b) Specific requirements. The requirements as specified in
provisions of subpart A of this part provisions of subpart A of this part § 721.125(a) through (c), and (k) are
apply to this section except as modified apply to this section except as modified applicable to manufacturers and
by this paragraph. by this paragraph. processors of this substance.
(1) Recordkeeping. Recordkeeping (1) Recordkeeping. Recordkeeping (2) Limitations or revocation of
requirements as specified in requirements as specified in certain notification requirements. The
§ 721.125(a) through (c), and (i) are § 721.125(a) through (c), and (k) are provisions of § 721.185 apply to this
applicable to manufacturers and applicable to manufacturers and section.
processors of this substance. processors of this substance. [FR Doc. 2015–13670 Filed 6–4–15; 8:45 am]
(2) Limitations or revocation of (2) Limitations or revocation of
BILLING CODE 6560–50–P
certain notification requirements. The certain notification requirements. The
provisions of § 721.185 apply to this provisions of § 721.185 apply to this
section. section. ENVIRONMENTAL PROTECTION
(3) Determining whether a specific use ■ 23. Add § 721.10849 to subpart E to AGENCY
is subject to this section. The provisions read as follows:
of § 721.1725(b)(1) apply to paragraph 40 CFR Part 52
(a)(2)(i) of this section. § 721.10849 Phenol-biphenyl-
formaldehyde polycondensate (generic). [EPA–R07–OAR–2014–0528; FRL–9928–59–
■ 21. Add § 721.10847 to subpart E to Region 7]
read as follows: (a) Chemical substance and
significant new uses subject to reporting. Approval and Promulgation of
§ 721.10847 Oxiranemethanaminium, (1) The chemical substance identified
N,N,N-trimethyl-, bromide. Implementation Plans; State of
generically as phenol-biphenyl- Kansas; Infrastructure SIP
(a) Chemical substance and formaldehyde polycondensate (PMN P– Requirements for the 2010 Sulfur
significant new uses subject to reporting. 15–115) is subject to reporting under Dioxide National Ambient Air Quality
(1) The chemical substance identified as this section for the significant new uses
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Standard
oxiranemethanaminium, N,N,N- described in paragraph (a)(2) of this
trimethyl-, bromide (PMN P–14–821; section. AGENCY: Environmental Protection
CAS No. 13895–77–7) is subject to (2) The significant new uses are: Agency.
reporting under this section for the (i) Release to water. Requirements as ACTION: Final rule.
significant new uses described in specified in § 721.90(a)(4), (b)(4), and
paragraph (a)(2) of this section. (c)(4) (N=5). SUMMARY: The Environmental Protection
(2) The significant new uses are: (ii) [Reserved] Agency (EPA) is taking final action to
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Document Created: 2015-12-15 15:20:40
Document Modified: 2015-12-15 15:20:40
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Direct final rule. | |
| Dates | This rule is effective on August 4, 2015. For purposes of judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on June 19, 2015. | |
| 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 | |
| FR Citation | 80 FR 32003 | |
| RIN Number | 2070-AB27 | |
| CFR Citation | 40
CFR
721 40 CFR 9 | |
| CFR Associated | Chemicals; Hazardous Substances; Environmental Protection and Reporting and Recordkeeping Requirements |
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