Significant New Use Rules on Certain Chemical Substances (19-6.B), 53663-53670 [2019-21718]

Download as PDF Federal Register / Vol. 84, No. 195 / Tuesday, October 8, 2019 / Proposed Rules Palma, Health and Environmental Impacts Division (C539–02), Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711; telephone number: (919) 541– 5470; fax number: (919) 541–0840; and email address: palma.ted@epa.gov. For information about monitoring and testing requirements, contact Kevin McGinn, Sector Policies and Programs Division (D230–02), Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711; telephone number: (919) 541– 3796; fax number: (919) 541–4991; and email address: mcginn.kevin@epa.gov. For information about the applicability of the Integrated Iron and Steel National Emission Standards for Hazardous Air Pollutants to a particular entity, contact Maria Malave, Office of Enforcement and Compliance Assurance, U.S. Environmental Protection Agency, WJC South Building (Mail Code 2227A), 1200 Pennsylvania Avenue NW, Washington DC 20460; telephone number: (202) 564–7027; and email address: malave.maria@epa.gov. SUPPLEMENTARY INFORMATION: To allow for additional time for stakeholders to provide comments and to review additional items submitted to the docket, the EPA has decided to reopen the public comment period until November 7, 2019. Dated: October 2, 2019. Panagiotis Tsirigotis, Director, Office of Air Quality Planning and Standards. [FR Doc. 2019–21827 Filed 10–7–19; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 721 [EPA–HQ–OPPT–2019–0529; FRL–10000– 60] RIN 2070–AB27 Significant New Use Rules on Certain Chemical Substances (19–6.B) Environmental Protection Agency (EPA). ACTION: Proposed rule. jbell on DSK3GLQ082PROD with PROPOSALS AGENCY: EPA is proposing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for seven chemical substances which are the subject of premanufacture notices (PMNs). This action would require persons to notify EPA at least 90 days before commencing manufacture SUMMARY: VerDate Sep<11>2014 18:28 Oct 07, 2019 Jkt 250001 (defined by statute to include import) or processing of any of these seven chemical substances for an activity that is designated as a significant new use by this proposed rule. This action would further require that persons not commence manufacture or processing for the significant new use until they have submitted a Significant New Use Notice, and EPA has conducted a review of the notice, made an appropriate determination on the notice under TSCA and has taken any risk management actions as are required as a result of that determination. DATES: Comments must be received on or before November 7, 2019. ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA–HQ–OPPT–2019–0529, 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: moss.kenneth@epa.gov. For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554– 1404; email address: TSCA-Hotline@ epa.gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this action apply to me? You may be potentially affected by this action if you manufacture, process, or use the chemical substances contained in this proposed rule. The PO 00000 Frm 00002 Fmt 4702 Sfmt 4702 53663 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 proposed SNURs would need to certify their compliance with the SNUR requirements should these proposed rules be finalized. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, pursuant to 40 CFR 721.20, any persons who export or intend to export a chemical substance that is the subject of this proposed rule on or after November 7, 2019 are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) 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 CBI 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. E:\FR\FM\08OCP1.SGM 08OCP1 53664 Federal Register / Vol. 84, No. 195 / Tuesday, October 8, 2019 / Proposed Rules II. Background A. What action is the agency taking? EPA is proposing these SNURs under TSCA section 5(a)(2) for chemical substances which were the subjects of PMNs P–17–109, P–17–234, P–17–400, P–18–92, P–18–105, P–18–295, and P– 19–113. These proposed SNURs would require persons who intend to manufacture or process any of these chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity. The record for the proposed SNURs on these chemicals was established as docket EPA–HQ–OPPT–2019–0529. That record includes information considered by the Agency in developing these proposed SNURs. jbell on DSK3GLQ082PROD with PROPOSALS B. What is the Agency’s authority for taking this action? TSCA section 5(a)(2) (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 TSCA section 5(a)(2) factors listed in Unit III. In the case of a determination other than not likely to present unreasonable risk, the applicable review period must also expire before manufacturing or processing for the new use may commence. As described in Unit V., the general SNUR provisions are found at 40 CFR part 721, subpart A. 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. Pursuant to 40 CFR 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) (15 U.S.C. 2604(a)(1)(A)). In particular, these requirements include the information submission requirements of TSCA sections 5(b) and 5(d)(1) (15 U.S.C. 2604(b) and 2604(d)(1)), the exemptions authorized by TSCA sections 5(h)(1), 5(h)(2), 5(h)(3), and 5(h)(5) and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA must either determine that the use is not likely to present an unreasonable risk of injury under the conditions of use for the chemical substance or take VerDate Sep<11>2014 18:28 Oct 07, 2019 Jkt 250001 such regulatory action as is associated with an alternative determination before the manufacture or processing for the significant new use can commence. If EPA determines that the use is not likely to present an unreasonable risk, EPA is required under TSCA section 5(g) to make public, and submit for publication in the Federal Register, a statement of EPA’s findings. III. Significant New Use Determination TSCA section 5(a)(2) 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 determining what would constitute a significant new use for the chemical substances that are the subject of these SNURs, EPA considered relevant information about the toxicity of the chemical substances, and potential human exposures and environmental releases that may be associated with the conditions of use of the substances, in the context of the four bulleted TSCA section 5(a)(2) factors listed in this unit. During its review of these chemicals, EPA identified certain conditions of use that are not intended by the submitters, but reasonably foreseen to occur. EPA is proposing to designate those reasonably foreseen conditions of use as significant new uses. IV. Substances Subject to This Proposed Rule EPA is proposing significant new use and recordkeeping requirements for seven 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 (if assigned for nonconfidential chemical identities). • Basis for the SNUR. • Information identified by EPA that would help characterize the potential health and/or environmental effects of PO 00000 Frm 00003 Fmt 4702 Sfmt 4702 the chemical substances if a manufacturer or processor is considering submitting a SNUN for a significant new use designated by the SNUR. This information may include testing not required to be conducted but which would help characterize the potential health and/or environmental effects of the PMN substance. Any recommendation for information identified by EPA was made based on EPA’s consideration of available screening-level data, if any, as well as other available information on appropriate testing for the chemical substance. Further, any such testing identified by EPA that includes testing on vertebrates was made after consideration of available toxicity information, computational toxicology and bioinformatics, and highthroughput screening methods and their prediction models. EPA also recognizes that whether testing/further information is needed will depend on the specific exposure and use scenario in the SNUN. EPA encourages all SNUN submitters to contact EPA to discuss any potential future testing. See Unit VII. for more information. • CFR citation assigned in the regulatory text section of these proposed rules. The regulatory text section of these proposed rules specifies the activities designated as significant new uses. Certain new uses, including production volume limits and other uses designated in the proposed rules, may be claimed as CBI. The chemical substances that are the subject of these proposed SNURs are undergoing premanufacture review. In addition to those conditions of use intended by the submitter, EPA has identified certain other reasonably foreseen conditions of use. EPA has preliminarily determined that the chemicals under their intended conditions of use are not likely to present an unreasonable risk. However, EPA has not assessed risks associated with the reasonably foreseen conditions of use for these chemicals. EPA is proposing to designate these reasonably foreseen and other potential conditions of use as significant new uses. As a result, those conditions of use are no longer reasonably foreseen to occur without first going through a separate, subsequent EPA review and determination process associated with a SNUN. The substances subject to these proposed rules are as follows: E:\FR\FM\08OCP1.SGM 08OCP1 Federal Register / Vol. 84, No. 195 / Tuesday, October 8, 2019 / Proposed Rules PMN Number: P–17–109 Chemical name: Alkyldiamine, aminoalkyl dimethylaminoalkyl dimethyl- (generic). CAS number: Not available. Basis for action: The PMN states that the use of the substance will be as an intermediate for a polyurethane catalyst and as a polyurethane catalyst. Based on the physical/chemical properties of the PMN substance and Structure Activity Relationships (SAR) analysis of test data on analogous substances, EPA has identified concerns for acute toxicity, irritation and corrosion to the eye, skin, respiratory tract and mucous membranes, neurotoxicity, blood effects, systemic effects, developmental effects, genotoxicity, and aquatic toxicity if the chemical substance is used in ways other than as intended by the PMN submitter. Other conditions of use of the PMN substance that EPA intends to assess before they occur include the following: 1. Manufacture, processing or use of the PMN substance in a manner that results in inhalation exposure. 2. Release of a manufacturing, processing, or use stream associated with any use of the PMN substance into the waters of the United States exceeding a surface water concentration of 660 ppb. The proposed SNUR would designate as a ‘‘significant new use’’ these conditions of use. Potentially useful information: EPA has determined that certain information about the human health and environmental toxicity of the PMN substance may be potentially useful to characterize the health effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that the results of acute toxicity, skin corrosion, eye damage, reproductive/ developmental toxicity, specific target organ toxicity, genetic toxicity, and environmental toxicity testing would help characterize the potential health and environmental effects of the PMN substance. CFR citation: 40 CFR 721.11412. jbell on DSK3GLQ082PROD with PROPOSALS PMN Number: P–17–234 Chemical name: Oxirane, 2(chloromethyl)-, polymer with 2methyloxirane polymer with oxirane bis(2-aminopropyl) ether. CAS number: 78390–60–0. Basis for action: The PMN states that the use of the substance will be as an adhesive intermediate. Based on the physical/chemical properties of the VerDate Sep<11>2014 18:28 Oct 07, 2019 Jkt 250001 PMN substance and Structure Activity Relationships (SAR) analysis of test data on analogous substances, EPA has identified concerns for sensitization, carcinogenicity, reproductive effects, lung effects (surfactancy), and toxicity to aquatic organisms at surface water concentrations exceeding 27 ppb, if the chemical substance is used in ways other than as intended by the PMN submitter. Other conditions of use of the PMN substance that EPA intends to assess before they occur include the following: 1. Use of the PMN substance other than as a chemical intermediate. 2. Release of a manufacturing, processing, or use stream associated with any use of the PMN substance into the waters of the United States exceeding a surface water concentration of 27 ppb. The proposed SNUR would designate as a ‘‘significant new use’’ these conditions of use. Potentially useful information: EPA has determined that certain information about the human health and environmental toxicity of the PMN substance may be potentially useful to characterize the health and environmental effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that the results of skin sensitization, respiratory sensitization, carcinogenicity, reproductive toxicity, specific target organ toxicity, and aquatic toxicity testing would help characterize the potential health and environmental effects of the PMN substance. CFR citation: 40 CFR 721.11413. PMN Number: P–17–400 Chemical name: Terpolymer of vinylidene fluoride, tetrafluoroethylene and 2,3,3,3-tetrafluoropropene (generic). CAS number: Not available. Basis for action: The PMN states that the generic (non-confidential) use of the substance will be in rubber products. Based on the physical/chemical properties of the PMN substance and Structure Activity Relationships (SAR) analysis of test data on analogous substances, EPA has identified concerns for lung overload if the chemical substance is used in ways other than as intended by the PMN submitter. Other conditions of use of the PMN substance that EPA intends to assess before they occur include the following: 1. Use of the PMN substance other than as described in the PMN; and PO 00000 Frm 00004 Fmt 4702 Sfmt 4702 53665 2. Manufacture, processing or use of the PMN substance in a manner that results in inhalation exposure. The proposed SNUR would designate as a ‘‘significant new use’’ these conditions of use. Potentially useful information: EPA has determined that certain information about the human health toxicity of the PMN substance may be potentially useful to characterize the health effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that the results of pulmonary effects testing would help characterize the potential health effects of the PMN substance. CFR citation: 40 CFR 721.11414. PMN Number: P–18–92 Chemical name: Phosphonium, tributylmethyl-, iodide (1:1). CAS number: 1702–42–7. Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a catalyst used in the manufacture of monoethylene glycol. Based on the physical/chemical properties of the PMN substance and Structure Activity Relationships (SAR) analysis of test data on analogous substances, EPA has identified concerns for liver effects and neurotoxicity if the chemical substance is used in ways other than as intended by the PMN submitter. Other conditions of use of the PMN substance that EPA intends to assess before they occur include the following: 1. Manufacture, processing or use of the PMN substance in a manner that results in inhalation exposure. 2. Release of a manufacturing, processing, or use stream associated with any use of the PMN substance into the waters of the United States exceeding a surface water concentration of 56 ppb. The proposed SNUR would designate as a ‘‘significant new use’’ these conditions of use. Potentially useful information: EPA has determined that certain information about the human health and environmental toxicity of the PMN substance may be potentially useful to characterize the health and environmental effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that the results of skin corrosion, eye damage, respiratory sensitization, skin sensitization, pulmonary effects, developmental effects and specific target organ toxicity E:\FR\FM\08OCP1.SGM 08OCP1 53666 Federal Register / Vol. 84, No. 195 / Tuesday, October 8, 2019 / Proposed Rules testing would help characterize the potential health and environmental effects of the PMN substance. CFR citation: 40 CFR 721.11415. jbell on DSK3GLQ082PROD with PROPOSALS PMN Number: P–18–105 Chemical name: Phosphorous acid, triisotridecyl ester. CAS number: 77745–66–5. Basis for action: The PMN states that the use of the substance will be in rigid and flexible polyvinyl chloride (PVC) processing as a booster of stabilizers. In addition, EPA has reviewed other known conditions of use of the substance as a coatings additive. Based on the physical/chemical properties of the PMN substance, available data for the PMN substance, and Structure Activity Relationships (SAR) analysis of test data on analogous substances, EPA has identified concerns for irritation, sensitization, and systemic and reproductive effects if the chemical substance is used in ways other than as intended by the PMN submitter. Other conditions of use of the PMN substance that EPA intends to assess before they occur include the following: 1. Use of the PMN substance other than as a booster of PVC stabilizers or as a coatings additive. 2. Use of the PMN substance without a National Institute for Occupational Safety and Health (NIOSH) certified respirator with an assigned protection factor of at least 50 where there is a potential for inhalation exposure, or at least 1000 where spray applied. The proposed SNUR would designate as a ‘‘significant new use’’ these conditions of use. Potentially useful information: EPA has determined that certain information about the human health toxicity of the PMN substance may be potentially useful to characterize the health effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that the results of skin irritation/corrosion, eye damage, and skin sensitization testing would help characterize the potential health effects of the PMN substance. CFR citation: 40 CFR 721.11416. PMN Number: P–18–295. Chemical name: 1,3-Butanediol, (3R)-. CAS number: 6290–03–5. Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an ingredient in the manufacture of consumer cleaning products and as a monomer in the manufacture of plastics products. Based on the physical/chemical properties of VerDate Sep<11>2014 18:28 Oct 07, 2019 Jkt 250001 the PMN substance and Structure Activity Relationships (SAR) analysis of test data on analogous substances, EPA has identified concerns for neurological, reproductive, and developmental effects if the chemical substance is used in ways other than as intended by the PMN submitter. Other conditions of use of the PMN substance that EPA intends to assess before they occur include the following: 1. Use of the PMN substance for other than as a chemical intermediate or other than as an ingredient in cleaning products; and 2. Manufacture within the United States (i.e., import only). The proposed SNUR would designate as a ‘‘significant new use’’ these conditions of use. Potentially useful information: EPA has determined that certain information about the human health toxicity of the PMN substance may be potentially useful to characterize the health effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that the results of neurotoxicity, specific organ toxicity, developmental and reproductive toxicity testing would help characterize the potential health effects of the PMN substance. CFR citation: 40 CFR 721.11417. PMN Number: P–19–113 Chemical name: Metal oxide-chloro (generic). CAS number: Not available Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a flow cell additive. Based on the physical/chemical properties of the PMN substance and Structure Activity Relationships (SAR) analysis of test data on analogous substances, EPA has identified concerns for acute toxicity, systemic toxicity, reproductive toxicity, developmental toxicity, neurotoxicity, immunotoxicity (asthma), lung cancer, irritation/ corrosion, serious eye damage, and toxicity to aquatic organisms at surface water concentrations exceeding 13 ppb, if the chemical substance is used in ways other than as intended by the PMN submitter. Other conditions of use of the PMN substance that EPA intends to assess before they occur include the following: 1. Use of the PMN substance other than as described in the PMN. 2. Manufacturing, processing, or use of the substance that results in inhalation exposures. 3. Release of a manufacturing, processing, or use stream associated PO 00000 Frm 00005 Fmt 4702 Sfmt 4702 with any use of the PMN substance into the waters of the United States exceeding a surface water concentration of 13 ppb. The proposed SNUR would designate as a ‘‘significant new use’’ these conditions of use. Potentially useful information: EPA has determined that certain information about the human health and environmental toxicity of the PMN substance may be potentially useful to characterize the health and environmental effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that the results of skin irritation/corrosion, eye damage, acute toxicity, specific target organ toxicity, pulmonary effects, reproductive/ developmental toxicity, neurotoxicity, carcinogenicity, and aquatic toxicity testing would help characterize the potential health and environmental effects of the PMN substance. CFR citation: 40 CFR 721.11419. V. Rationale and Objectives of the Proposed Rule A. Rationale During review of the PMNs submitted for the chemical substances that are the subject of these proposed SNURs and as further discussed in Unit IV., EPA identified certain other reasonably foreseen conditions of use, in addition to those conditions of use intended by the submitter. EPA has preliminarily determined that the chemical under the intended conditions of use is not likely to present an unreasonable risk. However, EPA has not assessed risks associated with the reasonably foreseen conditions of use. EPA is proposing to designate these conditions of use as significant new uses to ensure that they are no longer reasonably foreseen to occur without first going through a separate, subsequent EPA review and determination process associated with a SNUN. B. Objectives EPA is proposing these SNURs because the Agency wants: • To 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. • To be obligated to make a determination under TSCA section 5(a)(3) regarding the use described in the SNUN, under the conditions of use. The Agency will either determine under E:\FR\FM\08OCP1.SGM 08OCP1 Federal Register / Vol. 84, No. 195 / Tuesday, October 8, 2019 / Proposed Rules jbell on DSK3GLQ082PROD with PROPOSALS TSCA section 5(a)(3)(C) that the significant new use is not likely to present an unreasonable risk, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator under the conditions of use, or make a determination under TSCA section 5(a)(3)(A) or (B) and take the required regulatory action associated with the determination, before manufacture or processing for the significant new use of the chemical substance can occur. • To be able to complete its review and determination on each of the PMN substances, while deferring analysis on the significant new uses proposed in these rules unless and until the Agency receives a SNUN. Issuance of a proposed SNUR for a chemical substance does not signify that the chemical substance is listed on the TSCA Inventory. Guidance on how to determine if a chemical substance is on the TSCA Inventory is available on the internet at https://www.epa.gov/tscainventory. VI. Applicability of the Proposed Rules to Uses Occurring Before the Effective Date of the Final Rule To establish a significant new use, EPA must determine that the use is not ongoing. The chemical substances subject to this proposed rule were undergoing premanufacture review at the time of signature of this proposed rule and were not on the TSCA Inventory. 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 the chemical substances subject to these proposed SNURs, EPA concludes that the proposed significant new uses are not ongoing. EPA designates October 2, 2019 (date of web posting) as the cutoff date for determining whether the new use is ongoing. The objective of EPA’s approach is to ensure that a person cannot defeat a SNUR by initiating a significant new use before the effective date of the final rule. Persons who begin commercial manufacture or processing of the chemical substances for a significant new use identified on or after 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 EPA would have to take action under section 5 allowing VerDate Sep<11>2014 18:28 Oct 07, 2019 Jkt 250001 manufacture or processing to proceed. In developing this proposed rule, EPA has recognized that, given EPA’s general practice of posting proposed rules on its website a week or more in advance of Federal Register publication, this objective could be thwarted even before Federal Register publication of the proposed rule. VII. Development and Submission of Information EPA recognizes that TSCA section 5 does not require development of any particular new information (e.g., generating test data) before submission of a SNUN. There is an exception: If a person is required to submit information for a chemical substance pursuant to a rule, order or consent agreement under TSCA section 4 (15 U.S.C. 2603), then TSCA section 5(b)(1)(A) (15 U.S.C. 2604(b)(1)(A)) requires such information to be submitted to EPA at the time of submission of the SNUN. In the absence of a rule, order, or consent agreement under TSCA section 4 covering the chemical substance, persons are required only to submit information in their possession or control and to describe any other information 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. Unit IV. lists potentially useful information for all SNURs listed here. Descriptions are provided for informational purposes. The potentially useful information identified in Unit IV. will be useful to EPA’s evaluation in the event that someone submits a SNUN for the significant new use. Companies who are considering submitting a SNUN are encouraged, but not required, to develop the information on the substance, which may assist with EPA’s analysis of the SNUN. EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol selection. Furthermore, pursuant to TSCA section 4(h), which pertains to reduction of testing in vertebrate animals, EPA encourages consultation with the Agency on the use of alternative test methods and strategies (also called New Approach Methodologies, or NAMs), if available, to generate the recommended test data. EPA encourages dialog with Agency representatives to help determine how best the submitter can meet both the data needs and the objective of TSCA section 4(h). The potentially useful information described in Unit IV. may not be the only means of providing information to PO 00000 Frm 00006 Fmt 4702 Sfmt 4702 53667 evaluate the chemical substance associated with the significant new uses. However, submitting a SNUN without any test data may increase the likelihood that EPA will take action under TSCA sections 5(e) or 5(f). 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. VIII. SNUN Submissions According to 40 CFR 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 721.25. E–PMN software is available electronically at https:// www.epa.gov/reviewing-new-chemicalsunder-toxic-substances-control-act-tsca. IX. Economic Analysis EPA has evaluated the potential costs of establishing SNUN requirements for potential manufacturers and processors of the chemical substances subject to this proposed rule. EPA’s complete economic analysis is available in the docket under docket ID number EPA– HQ–OPPT–2019–0263. X. Statutory and Executive Order Reviews Additional information about these statutes and Executive Orders can be found at https://www.epa.gov/lawsregulations-and-executive-orders. A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulations and Regulatory Review This proposed rule would establish SNURs for seven new chemical substances that were the subject of PMNs. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011). E:\FR\FM\08OCP1.SGM 08OCP1 53668 Federal Register / Vol. 84, No. 195 / Tuesday, October 8, 2019 / Proposed Rules B. Paperwork Reduction Act (PRA) According to the 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. 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, Regulatory Support Division, Office of Mission Support (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. jbell on DSK3GLQ082PROD with PROPOSALS C. Regulatory Flexibility Act (RFA) Pursuant to section 605(b) of the RFA, 5 U.S.C. 601 et seq., the Agency hereby certifies that promulgation of this proposed SNUR would not have a significant adverse economic impact on a substantial number of small entities. The requirement to submit a SNUN applies to any person (including small or large entities) who intends to engage in any activity described in the final rule as a ‘‘significant new use.’’ Because these uses are ‘‘new,’’ based on all information currently available to EPA, it appears that no small or large entities presently engage in such activities. A SNUR requires that any person who intends to engage in such activity in the future must first notify EPA by submitting a SNUN. Although some small entities may decide to pursue a significant new use in the future, EPA VerDate Sep<11>2014 18:28 Oct 07, 2019 Jkt 250001 cannot presently determine how many, if any, there may be. However, EPA’s experience to date is that, in response to the promulgation of SNURs covering over 1,000 chemicals, the Agency receives only a small number of notices per year. For example, the number of SNUNs received was seven in Federal fiscal year (FY) 2013, 13 in FY2014, six in FY2015, 12 in FY2016, 13 in FY2017, and 11 in FY2018, only a fraction of these were from small businesses. In addition, the Agency currently offers relief to qualifying small businesses by reducing the SNUN submission fee from $16,000 to $2,800. This lower fee reduces the total reporting and recordkeeping of cost of submitting a SNUN to about $10,116 for qualifying small firms. Therefore, the potential economic impacts of complying with this proposed SNUR are not expected to be significant or adversely impact a substantial number of small entities. In a SNUR that published in the Federal Register of June 2, 1997 (62 FR 29684) (FRL–5597–1), the Agency presented its general determination that final SNURs are not expected to have a significant economic impact on a substantial number of small entities, which was provided to the Chief Counsel for Advocacy of the Small Business Administration. expected to have substantial direct effects on Indian Tribes. This proposed rule would not significantly nor uniquely affect the communities of Indian Tribal governments, nor does it involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175 (65 FR 67249, November 9, 2000), do not apply to this proposed rule. 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 proposed rule. As such, EPA has determined that this proposed rule 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. 1531–1538 et seq.). 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. E. Executive Order 13132: Federalism This action would not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments This proposed rule would not have Tribal implications because it is not PO 00000 Frm 00007 Fmt 4702 Sfmt 4702 G. Executive Order 13045: Protection of Children From Environmental Health and Safety Risks This action is not subject to Executive Order 13045 (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: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use This proposed rule is not subject to Executive Order 13211 (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. J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations This action does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898 (59 FR 7629, February 16, 1994). List of Subjects in 40 CFR Part 721 Environmental protection, Chemicals, Hazardous substances, Reporting and recordkeeping requirements. Dated: September 30, 2019. Tala Henry, Deputy Director, Office of Pollution Prevention and Toxics. Therefore, it is proposed that 40 CFR part 721 is amended as follows: PART 721—[AMENDED] 1. The authority citation for part 721 continues to read as follows: ■ Authority: 15 U.S.C. 2604, 2607, and 2625(c). E:\FR\FM\08OCP1.SGM 08OCP1 Federal Register / Vol. 84, No. 195 / Tuesday, October 8, 2019 / Proposed Rules 2. Add §§ 721.11412 through 721.11419 to subpart E to read as follows: ■ Subpart E—Significant New Uses for Specific Chemical Substances * * * * * Sec. § 721.11412 Alkyldiamine, aminoalkyl dimethylaminoalkyl dimethyl- (generic). § 721.11413 Oxirane, 2-(chloromethyl)-, polymer with 2-methyloxirane polymer with oxirane bis(2-aminopropyl) ether. § 721.11414 Terpolymer of vinylidene fluoride, tetrafluoroethylene and 2,3,3,3tetrafluoropropene (generic). § 721.11415 Phosphonium, tributylmethyl-, iodide (1:1) § 721.11416 Phosphorous acid, triisotridecyl ester. § 721.11417 1,3-Butanediol, (3R)-. § 721.11418 [Reserved]. § 721.11419 Metal oxide-chloro (generic). * * * * * § 721.11414 Terpolymer of vinylidene fluoride, tetrafluoroethylene and 2,3,3,3tetrafluoropropene (generic). § 721.11412 Alkyldiamine, aminoalkyl dimethylaminoalkyl dimethyl- (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as alkyldiamine, aminoalkyl dimethylaminoalkyl dimethyl- (PMN P– 17–109) 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. It is a significant new use to manufacture, processing or use of the PMN substance in a manner that results in inhalation exposure. (ii) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) where N = 660. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (c), (i), and (k) are applicable to manufacturers, importers, and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section. jbell on DSK3GLQ082PROD with PROPOSALS § 721.11413 Oxirane, 2-(chloromethyl)-, polymer with 2-methyloxirane polymer with oxirane bis(2-aminopropyl) ether. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as oxirane, 2-(chloromethyl)-, polymer with 2-methyloxirane polymer with oxirane bis(2-aminopropyl) ether (PMN P–17–234, CAS No. 78390–60–0) is subject to reporting under this section VerDate Sep<11>2014 18:28 Oct 07, 2019 Jkt 250001 for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(g). (ii) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) where N = 27. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (c), (i) and (k) are applicable to manufacturers, importers, and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as terpolymer of vinylidene fluoride, tetrafluoroethylene and 2,3,3,3tetrafluoropropene (PMN P–17–400) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80 (j). It is a significant new use to manufacture, processing or use of the PMN substance in a manner that results in inhalation exposure. (ii) [Reserved]. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (c), and (i) are applicable to manufacturers, importers, and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(i) of this section. § 721.11415 Phosphonium, tributylmethyl-, iodide (1:1). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as phosphonium, tributylmethyl-, iodide (1:1) (PMN P–18–92, CAS No. 1702–42– PO 00000 Frm 00008 Fmt 4702 Sfmt 4702 53669 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. It is a significant new use to manufacture, processing or use of the PMN substance in a manner that results in inhalation exposure. (ii) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) where N = 56. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (c), (i) and (k) are applicable to manufacturers, importers, and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section. § 721.11416 Phosphorous acid, triisotridecyl ester. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as phosphorous acid, triisotridecyl ester (PMN P–18–105, CAS No. 77745–66–5) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in § 721.63(a)(4), when determining which persons are reasonably likely to be exposed as required for § 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, (5)(respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor of at least 50, or at least 1,000 if spray applied, (a)(6)(particulate), (b)(concentration set at 1.0%), and (c). (ii) Industrial, commercial, and consumer activities. It is a significant new use to use the chemical substance for other than as a booster of polyvinyl chloride (PVC) stabilizers, or other than as a coatings additive. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (c), (d) and (i) are E:\FR\FM\08OCP1.SGM 08OCP1 53670 Federal Register / Vol. 84, No. 195 / Tuesday, October 8, 2019 / Proposed Rules applicable to manufacturers, importers, and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section. provisions of § 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(i) of this section. § 721.11417 [FR Doc. 2019–21718 Filed 10–7–19; 8:45 am] 1,3-Butanediol, (3R)-. jbell on DSK3GLQ082PROD with PROPOSALS (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1,3-butanediol, (3R)- (PMN P–18–295, CAS No. 6290–03–5) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Industrial, commercial, and consumer activities. Requirements as specified in 721.80(f) and (g). It is a significant new use to use the chemical substance for other than as an ingredient in cleaning products. (ii) [Reserved]. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (c), and (i) are applicable to manufacturers, importers, and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section. § 721.11418 [Reserved]. § 721.11419 Metal oxide-chloro (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as metal oxide-chloro (PMN P–19–113) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(j). It is a significant new use to manufacture, processing or use of the PMN substance in a manner that results in inhalation exposure. (ii) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) where N = 13. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (c), (i) and (k) are applicable to manufacturers, importers, and processors of this substance. (2) Limitations or revocation of certain notification requirements. The VerDate Sep<11>2014 18:28 Oct 07, 2019 Jkt 250001 BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 721 [EPA–HQ–OPPT–2014–0760; FRL–9998–80] RIN 2070–AB27 Significant New Use Rule on Certain Chemical Substances; Partial Withdrawal (PMN P–13–270) Environmental Protection Agency (EPA). ACTION: Partial withdrawal of proposed rule. AGENCY: EPA is withdrawing part of a proposed rule, published in the Federal Register on January 7, 2015, that proposed significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for certain chemical substances. This withdrawal covers only the portion of the proposed rule that would have established a SNUR for the chemical substance generically described as aromatic dibenzoate, which was the subject of premanufacture notice (PMN) P–13–270. EPA has received test data for this chemical substance and based on its review is withdrawing the proposed SNUR for the chemical substance. DATES: As of October 8, 2019, EPA withdraws the proposed addition of 40 CFR 721.10735, which published in the Federal Register of January 7, 2015 (80 FR 845) (FRL–9919–23). ADDRESSES: The docket for this action, identified by docket identification (ID) number EPA–HQ–OPPT–2014–0760, is available at http://www.regulations.gov or at the Office of Pollution Prevention and Toxics Docket (OPPT Docket), Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566–1744, and the telephone number for the OPPT Docket is (202) 566–0280. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets. SUMMARY: PO 00000 Frm 00009 Fmt 4702 Sfmt 4702 For technical information contact: Kenneth Moss, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001; telephone number: (202) 564–9232; email address: moss.kenneth@epa.gov. For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554– 1404; email address: TSCA-Hotline@ epa.gov. SUPPLEMENTARY INFORMATION: FOR FURTHER INFORMATION CONTACT: I. Does this action apply to me? A list of potentially affected entities is provided in the Federal Register of January 7, 2015 (80 FR 845) (FRL–9919– 23). If you have questions regarding the applicability of this action to a particular entity, consult the technical person listed under FOR FURTHER INFORMATION CONTACT. II. What proposed SNUR is being withdrawn? In the Federal Register of January 7, 2015 (80 FR 845) (FRL–9919–23), EPA issued proposed SNURs for 13 chemical substances, including the chemical substance generically described as aromatic dibenzoate, which was the subject of PMN P–13–270. EPA proposed a SNUR for this PMN substance that would designate certain activities as significant new uses based on a finding that the substance may cause significant adverse environmental effects and met the concern criteria at § 721.170(b)(4)(ii). The proposed SNUR would require notification before any use of the substance resulting in surface water concentrations exceeding 1 part per billion (ppb). In this Federal Register notice, EPA is only withdrawing the single proposed SNUR for PMN P–13–270 (proposed to be codified as 40 CFR 721.10735). III. Why is that proposed SNUR being withdrawn? Prior to the proposed SNUR, in the Federal Register of July 9, 2014 (79 FR 39268) (FRL–9910–01), EPA issued a direct final SNUR on this chemical substance in accordance with the procedures in 40 CFR 721.160(c)(3)(i). EPA received a notice of intent to submit adverse comments on the direct final SNUR, and, as required by 4 CFR 721.160(c)(3)(ii), EPA withdrew the direct final SNUR in the Federal Register of September 4, 2014 (79 FR 52563) (FRL–9915–69), which was subsequently followed by the issuance of the proposed rule in the Federal E:\FR\FM\08OCP1.SGM 08OCP1

Agencies

[Federal Register Volume 84, Number 195 (Tuesday, October 8, 2019)]
[Proposed Rules]
[Pages 53663-53670]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21718]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2019-0529; FRL-10000-60]
RIN 2070-AB27


Significant New Use Rules on Certain Chemical Substances (19-6.B)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing significant new use rules (SNURs) under the 
Toxic Substances Control Act (TSCA) for seven chemical substances which 
are the subject of premanufacture notices (PMNs). This action would 
require persons to notify EPA at least 90 days before commencing 
manufacture (defined by statute to include import) or processing of any 
of these seven chemical substances for an activity that is designated 
as a significant new use by this proposed rule. This action would 
further require that persons not commence manufacture or processing for 
the significant new use until they have submitted a Significant New Use 
Notice, and EPA has conducted a review of the notice, made an 
appropriate determination on the notice under TSCA and has taken any 
risk management actions as are required as a result of that 
determination.

DATES: Comments must be received on or before November 7, 2019.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2019-0529, 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: 

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 proposed 
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 proposed SNURs 
would need to certify their compliance with the SNUR requirements 
should these proposed rules be finalized. The EPA policy in support of 
import certification appears at 40 CFR part 707, subpart B. In 
addition, pursuant to 40 CFR 721.20, any persons who export or intend 
to export a chemical substance that is the subject of this proposed 
rule on or after November 7, 2019 are subject to the export 
notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) 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 CBI 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.

[[Page 53664]]

II. Background

A. What action is the agency taking?

    EPA is proposing these SNURs under TSCA section 5(a)(2) for 
chemical substances which were the subjects of PMNs P-17-109, P-17-234, 
P-17-400, P-18-92, P-18-105, P-18-295, and P-19-113. These proposed 
SNURs would require persons who intend to manufacture or process any of 
these chemical substances for an activity that is designated as a 
significant new use to notify EPA at least 90 days before commencing 
that activity.
    The record for the proposed SNURs on these chemicals was 
established as docket EPA-HQ-OPPT-2019-0529. That record includes 
information considered by the Agency in developing these proposed 
SNURs.

B. What is the Agency's authority for taking this action?

    TSCA section 5(a)(2) (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 TSCA section 5(a)(2) factors 
listed in Unit III. In the case of a determination other than not 
likely to present unreasonable risk, the applicable review period must 
also expire before manufacturing or processing for the new use may 
commence. As described in Unit V., the general SNUR provisions are 
found at 40 CFR part 721, subpart A.

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. Pursuant to 
40 CFR 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) (15 U.S.C. 2604(a)(1)(A)). In 
particular, these requirements include the information submission 
requirements of TSCA sections 5(b) and 5(d)(1) (15 U.S.C. 2604(b) and 
2604(d)(1)), the exemptions authorized by TSCA sections 5(h)(1), 
5(h)(2), 5(h)(3), and 5(h)(5) and the regulations at 40 CFR part 720. 
Once EPA receives a SNUN, EPA must either determine that the use is not 
likely to present an unreasonable risk of injury under the conditions 
of use for the chemical substance or take such regulatory action as is 
associated with an alternative determination before the manufacture or 
processing for the significant new use can commence. If EPA determines 
that the use is not likely to present an unreasonable risk, EPA is 
required under TSCA section 5(g) to make public, and submit for 
publication in the Federal Register, a statement of EPA's findings.

III. Significant New Use Determination

    TSCA section 5(a)(2) 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 determining what would constitute a significant new use for the 
chemical substances that are the subject of these SNURs, EPA considered 
relevant information about the toxicity of the chemical substances, and 
potential human exposures and environmental releases that may be 
associated with the conditions of use of the substances, in the context 
of the four bulleted TSCA section 5(a)(2) factors listed in this unit. 
During its review of these chemicals, EPA identified certain conditions 
of use that are not intended by the submitters, but reasonably foreseen 
to occur. EPA is proposing to designate those reasonably foreseen 
conditions of use as significant new uses.

IV. Substances Subject to This Proposed Rule

    EPA is proposing significant new use and recordkeeping requirements 
for seven 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 (if 
assigned for non-confidential chemical identities).
     Basis for the SNUR.
     Information identified by EPA that would help characterize 
the potential health and/or environmental effects of the chemical 
substances if a manufacturer or processor is considering submitting a 
SNUN for a significant new use designated by the SNUR.
    This information may include testing not required to be conducted 
but which would help characterize the potential health and/or 
environmental effects of the PMN substance. Any recommendation for 
information identified by EPA was made based on EPA's consideration of 
available screening-level data, if any, as well as other available 
information on appropriate testing for the chemical substance. Further, 
any such testing identified by EPA that includes testing on vertebrates 
was made after consideration of available toxicity information, 
computational toxicology and bioinformatics, and high-throughput 
screening methods and their prediction models. EPA also recognizes that 
whether testing/further information is needed will depend on the 
specific exposure and use scenario in the SNUN. EPA encourages all SNUN 
submitters to contact EPA to discuss any potential future testing. See 
Unit VII. for more information.
     CFR citation assigned in the regulatory text section of 
these proposed rules.
    The regulatory text section of these proposed rules specifies the 
activities designated as significant new uses. Certain new uses, 
including production volume limits and other uses designated in the 
proposed rules, may be claimed as CBI.
    The chemical substances that are the subject of these proposed 
SNURs are undergoing premanufacture review. In addition to those 
conditions of use intended by the submitter, EPA has identified certain 
other reasonably foreseen conditions of use. EPA has preliminarily 
determined that the chemicals under their intended conditions of use 
are not likely to present an unreasonable risk. However, EPA has not 
assessed risks associated with the reasonably foreseen conditions of 
use for these chemicals. EPA is proposing to designate these reasonably 
foreseen and other potential conditions of use as significant new uses. 
As a result, those conditions of use are no longer reasonably foreseen 
to occur without first going through a separate, subsequent EPA review 
and determination process associated with a SNUN.
    The substances subject to these proposed rules are as follows:

[[Page 53665]]

PMN Number: P-17-109

    Chemical name: Alkyldiamine, aminoalkyl dimethylaminoalkyl 
dimethyl- (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the use of the substance will 
be as an intermediate for a polyurethane catalyst and as a polyurethane 
catalyst. Based on the physical/chemical properties of the PMN 
substance and Structure Activity Relationships (SAR) analysis of test 
data on analogous substances, EPA has identified concerns for acute 
toxicity, irritation and corrosion to the eye, skin, respiratory tract 
and mucous membranes, neurotoxicity, blood effects, systemic effects, 
developmental effects, genotoxicity, and aquatic toxicity if the 
chemical substance is used in ways other than as intended by the PMN 
submitter. Other conditions of use of the PMN substance that EPA 
intends to assess before they occur include the following:
    1. Manufacture, processing or use of the PMN substance in a manner 
that results in inhalation exposure.
    2. Release of a manufacturing, processing, or use stream associated 
with any use of the PMN substance into the waters of the United States 
exceeding a surface water concentration of 660 ppb.
    The proposed SNUR would designate as a ``significant new use'' 
these conditions of use.
    Potentially useful information: EPA has determined that certain 
information about the human health and environmental toxicity of the 
PMN substance may be potentially useful to characterize the health 
effects of the PMN substance if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that would be 
designated by this proposed SNUR. EPA has determined that the results 
of acute toxicity, skin corrosion, eye damage, reproductive/
developmental toxicity, specific target organ toxicity, genetic 
toxicity, and environmental toxicity testing would help characterize 
the potential health and environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.11412.

PMN Number: P-17-234

    Chemical name: Oxirane, 2-(chloromethyl)-, polymer with 2-
methyloxirane polymer with oxirane bis(2-aminopropyl) ether.
    CAS number: 78390-60-0.
    Basis for action: The PMN states that the use of the substance will 
be as an adhesive intermediate. Based on the physical/chemical 
properties of the PMN substance and Structure Activity Relationships 
(SAR) analysis of test data on analogous substances, EPA has identified 
concerns for sensitization, carcinogenicity, reproductive effects, lung 
effects (surfactancy), and toxicity to aquatic organisms at surface 
water concentrations exceeding 27 ppb, if the chemical substance is 
used in ways other than as intended by the PMN submitter. Other 
conditions of use of the PMN substance that EPA intends to assess 
before they occur include the following:
    1. Use of the PMN substance other than as a chemical intermediate.
    2. Release of a manufacturing, processing, or use stream associated 
with any use of the PMN substance into the waters of the United States 
exceeding a surface water concentration of 27 ppb.
    The proposed SNUR would designate as a ``significant new use'' 
these conditions of use.
    Potentially useful information: EPA has determined that certain 
information about the human health and environmental toxicity of the 
PMN substance may be potentially useful to characterize the health and 
environmental effects of the PMN substance if a manufacturer or 
processor is considering submitting a SNUN for a significant new use 
that would be designated by this proposed SNUR. EPA has determined that 
the results of skin sensitization, respiratory sensitization, 
carcinogenicity, reproductive toxicity, specific target organ toxicity, 
and aquatic toxicity testing would help characterize the potential 
health and environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.11413.

PMN Number: P-17-400

    Chemical name: Terpolymer of vinylidene fluoride, 
tetrafluoroethylene and 2,3,3,3-tetrafluoropropene (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be in rubber products. Based on 
the physical/chemical properties of the PMN substance and Structure 
Activity Relationships (SAR) analysis of test data on analogous 
substances, EPA has identified concerns for lung overload if the 
chemical substance is used in ways other than as intended by the PMN 
submitter. Other conditions of use of the PMN substance that EPA 
intends to assess before they occur include the following:
    1. Use of the PMN substance other than as described in the PMN; and
    2. Manufacture, processing or use of the PMN substance in a manner 
that results in inhalation exposure.
    The proposed SNUR would designate as a ``significant new use'' 
these conditions of use.
    Potentially useful information: EPA has determined that certain 
information about the human health toxicity of the PMN substance may be 
potentially useful to characterize the health effects of the PMN 
substance if a manufacturer or processor is considering submitting a 
SNUN for a significant new use that would be designated by this 
proposed SNUR. EPA has determined that the results of pulmonary effects 
testing would help characterize the potential health effects of the PMN 
substance.
    CFR citation: 40 CFR 721.11414.

PMN Number: P-18-92

    Chemical name: Phosphonium, tributylmethyl-, iodide (1:1).
    CAS number: 1702-42-7.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a catalyst used in the 
manufacture of monoethylene glycol. Based on the physical/chemical 
properties of the PMN substance and Structure Activity Relationships 
(SAR) analysis of test data on analogous substances, EPA has identified 
concerns for liver effects and neurotoxicity if the chemical substance 
is used in ways other than as intended by the PMN submitter. Other 
conditions of use of the PMN substance that EPA intends to assess 
before they occur include the following:
    1. Manufacture, processing or use of the PMN substance in a manner 
that results in inhalation exposure.
    2. Release of a manufacturing, processing, or use stream associated 
with any use of the PMN substance into the waters of the United States 
exceeding a surface water concentration of 56 ppb.
    The proposed SNUR would designate as a ``significant new use'' 
these conditions of use.
    Potentially useful information: EPA has determined that certain 
information about the human health and environmental toxicity of the 
PMN substance may be potentially useful to characterize the health and 
environmental effects of the PMN substance if a manufacturer or 
processor is considering submitting a SNUN for a significant new use 
that would be designated by this proposed SNUR. EPA has determined that 
the results of skin corrosion, eye damage, respiratory sensitization, 
skin sensitization, pulmonary effects, developmental effects and 
specific target organ toxicity

[[Page 53666]]

testing would help characterize the potential health and environmental 
effects of the PMN substance.
    CFR citation: 40 CFR 721.11415.

PMN Number: P-18-105

    Chemical name: Phosphorous acid, triisotridecyl ester.
    CAS number: 77745-66-5.
    Basis for action: The PMN states that the use of the substance will 
be in rigid and flexible polyvinyl chloride (PVC) processing as a 
booster of stabilizers. In addition, EPA has reviewed other known 
conditions of use of the substance as a coatings additive. Based on the 
physical/chemical properties of the PMN substance, available data for 
the PMN substance, and Structure Activity Relationships (SAR) analysis 
of test data on analogous substances, EPA has identified concerns for 
irritation, sensitization, and systemic and reproductive effects if the 
chemical substance is used in ways other than as intended by the PMN 
submitter. Other conditions of use of the PMN substance that EPA 
intends to assess before they occur include the following:
    1. Use of the PMN substance other than as a booster of PVC 
stabilizers or as a coatings additive.
    2. Use of the PMN substance without a National Institute for 
Occupational Safety and Health (NIOSH) certified respirator with an 
assigned protection factor of at least 50 where there is a potential 
for inhalation exposure, or at least 1000 where spray applied.
    The proposed SNUR would designate as a ``significant new use'' 
these conditions of use.
    Potentially useful information: EPA has determined that certain 
information about the human health toxicity of the PMN substance may be 
potentially useful to characterize the health effects of the PMN 
substance if a manufacturer or processor is considering submitting a 
SNUN for a significant new use that would be designated by this 
proposed SNUR. EPA has determined that the results of skin irritation/
corrosion, eye damage, and skin sensitization testing would help 
characterize the potential health effects of the PMN substance.
    CFR citation: 40 CFR 721.11416.

PMN Number: P-18-295.

    Chemical name: 1,3-Butanediol, (3R)-.
    CAS number: 6290-03-5.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an ingredient in the 
manufacture of consumer cleaning products and as a monomer in the 
manufacture of plastics products. Based on the physical/chemical 
properties of the PMN substance and Structure Activity Relationships 
(SAR) analysis of test data on analogous substances, EPA has identified 
concerns for neurological, reproductive, and developmental effects if 
the chemical substance is used in ways other than as intended by the 
PMN submitter. Other conditions of use of the PMN substance that EPA 
intends to assess before they occur include the following:
    1. Use of the PMN substance for other than as a chemical 
intermediate or other than as an ingredient in cleaning products; and
    2. Manufacture within the United States (i.e., import only).
    The proposed SNUR would designate as a ``significant new use'' 
these conditions of use.
    Potentially useful information: EPA has determined that certain 
information about the human health toxicity of the PMN substance may be 
potentially useful to characterize the health effects of the PMN 
substance if a manufacturer or processor is considering submitting a 
SNUN for a significant new use that would be designated by this 
proposed SNUR. EPA has determined that the results of neurotoxicity, 
specific organ toxicity, developmental and reproductive toxicity 
testing would help characterize the potential health effects of the PMN 
substance.
    CFR citation: 40 CFR 721.11417.

PMN Number: P-19-113

    Chemical name: Metal oxide-chloro (generic).
    CAS number: Not available
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a flow cell additive. 
Based on the physical/chemical properties of the PMN substance and 
Structure Activity Relationships (SAR) analysis of test data on 
analogous substances, EPA has identified concerns for acute toxicity, 
systemic toxicity, reproductive toxicity, developmental toxicity, 
neurotoxicity, immunotoxicity (asthma), lung cancer, irritation/
corrosion, serious eye damage, and toxicity to aquatic organisms at 
surface water concentrations exceeding 13 ppb, if the chemical 
substance is used in ways other than as intended by the PMN submitter. 
Other conditions of use of the PMN substance that EPA intends to assess 
before they occur include the following:
    1. Use of the PMN substance other than as described in the PMN.
    2. Manufacturing, processing, or use of the substance that results 
in inhalation exposures.
    3. Release of a manufacturing, processing, or use stream associated 
with any use of the PMN substance into the waters of the United States 
exceeding a surface water concentration of 13 ppb.
    The proposed SNUR would designate as a ``significant new use'' 
these conditions of use.
    Potentially useful information: EPA has determined that certain 
information about the human health and environmental toxicity of the 
PMN substance may be potentially useful to characterize the health and 
environmental effects of the PMN substance if a manufacturer or 
processor is considering submitting a SNUN for a significant new use 
that would be designated by this proposed SNUR. EPA has determined that 
the results of skin irritation/corrosion, eye damage, acute toxicity, 
specific target organ toxicity, pulmonary effects, reproductive/
developmental toxicity, neurotoxicity, carcinogenicity, and aquatic 
toxicity testing would help characterize the potential health and 
environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.11419.

V. Rationale and Objectives of the Proposed Rule

A. Rationale

    During review of the PMNs submitted for the chemical substances 
that are the subject of these proposed SNURs and as further discussed 
in Unit IV., EPA identified certain other reasonably foreseen 
conditions of use, in addition to those conditions of use intended by 
the submitter. EPA has preliminarily determined that the chemical under 
the intended conditions of use is not likely to present an unreasonable 
risk. However, EPA has not assessed risks associated with the 
reasonably foreseen conditions of use. EPA is proposing to designate 
these conditions of use as significant new uses to ensure that they are 
no longer reasonably foreseen to occur without first going through a 
separate, subsequent EPA review and determination process associated 
with a SNUN.

B. Objectives

    EPA is proposing these SNURs because the Agency wants:
     To 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.
     To be obligated to make a determination under TSCA section 
5(a)(3) regarding the use described in the SNUN, under the conditions 
of use. The Agency will either determine under

[[Page 53667]]

TSCA section 5(a)(3)(C) that the significant new use is not likely to 
present an unreasonable risk, including an unreasonable risk to a 
potentially exposed or susceptible subpopulation identified as relevant 
by the Administrator under the conditions of use, or make a 
determination under TSCA section 5(a)(3)(A) or (B) and take the 
required regulatory action associated with the determination, before 
manufacture or processing for the significant new use of the chemical 
substance can occur.
     To be able to complete its review and determination on 
each of the PMN substances, while deferring analysis on the significant 
new uses proposed in these rules unless and until the Agency receives a 
SNUN.
    Issuance of a proposed SNUR for a chemical substance does not 
signify that the chemical substance is listed on the TSCA Inventory. 
Guidance on how to determine if a chemical substance is on the TSCA 
Inventory is available on the internet at https://www.epa.gov/tsca-inventory.

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

    To establish a significant new use, EPA must determine that the use 
is not ongoing. The chemical substances subject to this proposed rule 
were undergoing premanufacture review at the time of signature of this 
proposed rule and were not on the TSCA Inventory. 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 
the chemical substances subject to these proposed SNURs, EPA concludes 
that the proposed significant new uses are not ongoing.
    EPA designates October 2, 2019 (date of web posting) as the cutoff 
date for determining whether the new use is ongoing. The objective of 
EPA's approach is to ensure that a person cannot defeat a SNUR by 
initiating a significant new use before the effective date of the final 
rule.
    Persons who begin commercial manufacture or processing of the 
chemical substances for a significant new use identified on or after 
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 
EPA would have to take action under section 5 allowing manufacture or 
processing to proceed. In developing this proposed rule, EPA has 
recognized that, given EPA's general practice of posting proposed rules 
on its website a week or more in advance of Federal Register 
publication, this objective could be thwarted even before Federal 
Register publication of the proposed rule.

VII. Development and Submission of Information

    EPA recognizes that TSCA section 5 does not require development of 
any particular new information (e.g., generating test data) before 
submission of a SNUN. There is an exception: If a person is required to 
submit information for a chemical substance pursuant to a rule, order 
or consent agreement under TSCA section 4 (15 U.S.C. 2603), then TSCA 
section 5(b)(1)(A) (15 U.S.C. 2604(b)(1)(A)) requires such information 
to be submitted to EPA at the time of submission of the SNUN.
    In the absence of a rule, order, or consent agreement under TSCA 
section 4 covering the chemical substance, persons are required only to 
submit information in their possession or control and to describe any 
other information 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. Unit IV. lists potentially 
useful information for all SNURs listed here. Descriptions are provided 
for informational purposes. The potentially useful information 
identified in Unit IV. will be useful to EPA's evaluation in the event 
that someone submits a SNUN for the significant new use. Companies who 
are considering submitting a SNUN are encouraged, but not required, to 
develop the information on the substance, which may assist with EPA's 
analysis of the SNUN.
    EPA strongly encourages persons, before performing any testing, to 
consult with the Agency pertaining to protocol selection. Furthermore, 
pursuant to TSCA section 4(h), which pertains to reduction of testing 
in vertebrate animals, EPA encourages consultation with the Agency on 
the use of alternative test methods and strategies (also called New 
Approach Methodologies, or NAMs), if available, to generate the 
recommended test data. EPA encourages dialog with Agency 
representatives to help determine how best the submitter can meet both 
the data needs and the objective of TSCA section 4(h).
    The potentially useful information described in Unit IV. may not be 
the only means of providing information to evaluate the chemical 
substance associated with the significant new uses. However, submitting 
a SNUN without any test data may increase the likelihood that EPA will 
take action under TSCA sections 5(e) or 5(f). 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.

VIII. SNUN Submissions

    According to 40 CFR 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 721.25. E-PMN software is available 
electronically at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.

IX. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN 
requirements for potential manufacturers and processors of the chemical 
substances subject to this proposed rule. EPA's complete economic 
analysis is available in the docket under docket ID number EPA-HQ-OPPT-
2019-0263.

X. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders 
can be found at https://www.epa.gov/laws-regulations-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive 
Order 13563: Improving Regulations and Regulatory Review

    This proposed rule would establish SNURs for seven new chemical 
substances that were the subject of PMNs. The Office of Management and 
Budget (OMB) has exempted these types of actions from review under 
Executive Order 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 
3821, January 21, 2011).

[[Page 53668]]

B. Paperwork Reduction Act (PRA)

    According to the 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.
    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, 
Regulatory Support Division, Office of Mission Support (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)

    Pursuant to section 605(b) of the RFA, 5 U.S.C. 601 et seq., the 
Agency hereby certifies that promulgation of this proposed SNUR would 
not have a significant adverse economic impact on a substantial number 
of small entities. The requirement to submit a SNUN applies to any 
person (including small or large entities) who intends to engage in any 
activity described in the final rule as a ``significant new use.'' 
Because these uses are ``new,'' based on all information currently 
available to EPA, it appears that no small or large entities presently 
engage in such activities. A SNUR requires that any person who intends 
to engage in such activity in the future must first notify EPA by 
submitting a SNUN. Although some small entities may decide to pursue a 
significant new use in the future, EPA cannot presently determine how 
many, if any, there may be. However, EPA's experience to date is that, 
in response to the promulgation of SNURs covering over 1,000 chemicals, 
the Agency receives only a small number of notices per year. For 
example, the number of SNUNs received was seven in Federal fiscal year 
(FY) 2013, 13 in FY2014, six in FY2015, 12 in FY2016, 13 in FY2017, and 
11 in FY2018, only a fraction of these were from small businesses. In 
addition, the Agency currently offers relief to qualifying small 
businesses by reducing the SNUN submission fee from $16,000 to $2,800. 
This lower fee reduces the total reporting and recordkeeping of cost of 
submitting a SNUN to about $10,116 for qualifying small firms. 
Therefore, the potential economic impacts of complying with this 
proposed SNUR are not expected to be significant or adversely impact a 
substantial number of small entities. In a SNUR that published in the 
Federal Register of June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency 
presented its general determination that final SNURs are not expected 
to have a significant economic impact on a substantial number of small 
entities, which was provided to the Chief Counsel for Advocacy of the 
Small Business Administration.

D. Unfunded Mandates Reform Act (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 proposed 
rule. As such, EPA has determined that this proposed rule 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. 1531-1538 et seq.).

E. Executive Order 13132: Federalism

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

F. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    This proposed rule would not have Tribal implications because it is 
not expected to have substantial direct effects on Indian Tribes. This 
proposed rule would not significantly nor uniquely affect the 
communities of Indian Tribal governments, nor does it involve or impose 
any requirements that affect Indian Tribes. Accordingly, the 
requirements of Executive Order 13175 (65 FR 67249, November 9, 2000), 
do not apply to this proposed rule.

G. Executive Order 13045: Protection of Children From Environmental 
Health and Safety Risks

    This action is not subject to Executive Order 13045 (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: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use

    This proposed rule is not subject to Executive Order 13211 (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: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations

    This action does not entail special considerations of environmental 
justice related issues as delineated by Executive Order 12898 (59 FR 
7629, February 16, 1994).

List of Subjects in 40 CFR Part 721

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

    Dated: September 30, 2019.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.
    Therefore, it is proposed that 40 CFR part 721 is amended as 
follows:

PART 721--[AMENDED]

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

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


[[Page 53669]]


0
2. Add Sec. Sec.  721.11412 through 721.11419 to subpart E to read as 
follows:

Subpart E--Significant New Uses for Specific Chemical Substances

* * * * *
Sec.
Sec.  721.11412 Alkyldiamine, aminoalkyl dimethylaminoalkyl 
dimethyl- (generic).
Sec.  721.11413 Oxirane, 2-(chloromethyl)-, polymer with 2-
methyloxirane polymer with oxirane bis(2-aminopropyl) ether.
Sec.  721.11414 Terpolymer of vinylidene fluoride, 
tetrafluoroethylene and 2,3,3,3-tetrafluoropropene (generic).
Sec.  721.11415 Phosphonium, tributylmethyl-, iodide (1:1)
Sec.  721.11416 Phosphorous acid, triisotridecyl ester.
Sec.  721.11417 1,3-Butanediol, (3R)-.
Sec.  721.11418 [Reserved].
Sec.  721.11419 Metal oxide-chloro (generic).
* * * * *


Sec.  721.11412  Alkyldiamine, aminoalkyl dimethylaminoalkyl dimethyl- 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as alkyldiamine, 
aminoalkyl dimethylaminoalkyl dimethyl- (PMN P-17-109) 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. It is a 
significant new use to manufacture, processing or use of the PMN 
substance in a manner that results in inhalation exposure.
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N = 660.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (i), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11413  Oxirane, 2-(chloromethyl)-, polymer with 2-
methyloxirane polymer with oxirane bis(2-aminopropyl) ether.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as oxirane, 2-
(chloromethyl)-, polymer with 2-methyloxirane polymer with oxirane 
bis(2-aminopropyl) ether (PMN P-17-234, CAS No. 78390-60-0) is subject 
to reporting under this section for the significant new uses described 
in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(g).
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N = 27.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (i) and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11414  Terpolymer of vinylidene fluoride, tetrafluoroethylene 
and 2,3,3,3-tetrafluoropropene (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
terpolymer of vinylidene fluoride, tetrafluoroethylene and 2,3,3,3-
tetrafluoropropene (PMN P-17-400) 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). It is a significant new use to 
manufacture, processing or use of the PMN substance in a manner that 
results in inhalation exposure.
    (ii) [Reserved].
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of 
this section.


Sec.  721.11415  Phosphonium, tributylmethyl-, iodide (1:1).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as phosphonium, 
tributylmethyl-, iodide (1:1) (PMN P-18-92, CAS No. 1702-42-7) 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. It is a 
significant new use to manufacture, processing or use of the PMN 
substance in a manner that results in inhalation exposure.
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N = 56.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (i) and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11416  Phosphorous acid, triisotridecyl ester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as phosphorous acid, 
triisotridecyl ester (PMN P-18-105, CAS No. 77745-66-5) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(4), 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, (5)(respirators must provide a National 
Institute for Occupational Safety and Health (NIOSH) assigned 
protection factor of at least 50, or at least 1,000 if spray applied, 
(a)(6)(particulate), (b)(concentration set at 1.0%), and (c).
    (ii) Industrial, commercial, and consumer activities. It is a 
significant new use to use the chemical substance for other than as a 
booster of polyvinyl chloride (PVC) stabilizers, or other than as a 
coatings additive.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (d) and (i) are

[[Page 53670]]

applicable to manufacturers, importers, and processors of this 
substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11417  1,3-Butanediol, (3R)-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1,3-butanediol, 
(3R)- (PMN P-18-295, CAS No. 6290-03-5) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in 721.80(f) and (g). It is a significant new use to use 
the chemical substance for other than as an ingredient in cleaning 
products.
    (ii) [Reserved].
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11418  [Reserved].


Sec.  721.11419  Metal oxide-chloro (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as metal 
oxide-chloro (PMN P-19-113) 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). It is a significant new use to 
manufacture, processing or use of the PMN substance in a manner that 
results in inhalation exposure.
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N = 13.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (i) and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (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.

[FR Doc. 2019-21718 Filed 10-7-19; 8:45 am]
 BILLING CODE 6560-50-P