Significant New Use Rules on Certain Chemical Substances (19-1), 16432-16441 [2019-07853]

Download as PDF khammond on DSKBBV9HB2PROD with PROPOSALS 16432 Federal Register / Vol. 84, No. 76 / Friday, April 19, 2019 / Proposed Rules Using Liquid Chromatography, Tandem Mass Spectrometry (LC–MS/MS)’’ was validated successfully for the analysis of cyflumetofen and its metabolites. The analytical method has a limit of quantitation (LOQ) of 0.01 ppm for residues of cyflumetofen and its metabolites in all matrix types. Contact: RD. 4. PP 8F8696. (EPA–HQ–OPP–2018– 0688). Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, NC 27419, requests to establish a tolerance in 40 CFR part 180 for residues of the fungicide, pydiflumetofen, in or on Root Vegetable Crop Subgroup 1A at 0.30 parts per million (ppm); Bulb Vegetable Crop Subgroup 3–07A at 0.20 ppm; Bulb Vegetable Crop Subgroup 3–07B at 2 ppm; Brassica Leafy Greens Subgroup 4–16B at 50 ppm; Brassica Head and Stem Crop Group 5–16 at 3 ppm; Leaves of Root and Tuber Vegetables, Crop Group 2 at 15.0 ppm; Edible-podded Legume Vegetable Subgroup 6A at 1.0 ppm; Succulent Shelled Pea and Bean Subgroup 6B at 0.09 ppm; Citrus Fruit Crop Group 10–10 at 0.90 ppm; Citrus oil at 15 ppm; Pome Fruit Crop Group 11–10 at 0.20 ppm; Apple, Wet Pomace at 1.0 ppm; Stone Fruit, Cherry Subgroup 12–12A at 2.0 ppm; Stone Fruit, Peach Subgroup 12–12B at 1.0 ppm; Stone Fruit, Plum Subgroup 12– 12C at 0.6 ppm; Plum, Prune at 1.5 ppm; Bushberry Crop Subgroup 13–07B at 5 ppm; Berries, Low Growing Crop Subgroup 13–07G, except cranberry and blueberry, at 1 ppm; Tree Nuts Crop Group 14–12, Nutmeat at 0.05 ppm; Almond Hull at 9.0 ppm; Cottonseed Subgroup 20C, Cotton Undelinted Seed at 0.4 ppm; Cotton Gin By-Products at 7.0 ppm; Sunflower Subgroup 20B at 0.60 ppm; Sorghum grain at 3.0 ppm; Sorghum forage at 1.5 ppm; and Sorghum Stover at 10 ppm. The QuEChERS method is used to measure and evaluate the chemical in plant commodities. Contact: RD. 5. PP 8F8709. (EPA–HQ–OPP–2018– 0762). BASF corporation, 26 Davis Drive, P.O. Box 13528, Research Triangle Park, NC 27709, requests to establish a tolerance in 40 CFR part 180 for residues of the herbicide, Trifludimoxazin 1,5-dimethyl-6-thioxo3-[2,2,7-trifluoro-3-oxo-4-(prop-2-yn-1yl)-3,4-dihydro-2-1,4-benzoazin-6-yl]1,3,5-triazinane-2,4-dione, in or on Almond, hulls at 0.15 parts per million (ppm); Fruit, citrus, group 10–10 at 0.01 ppm; Fruit, pome, group 11–10 at 0.01 ppm; Grain, cereal, forage, fodder and straw, group 16 at 0.01 ppm; Grain, cereal, group 15 at 0.01 ppm; Nut, tree, group 14–12 at 0.01 ppm; Peanut at 0.01 ppm; Peanut, hay at 0.01 ppm; Vegetable, foliage of legume, group 07 at VerDate Sep<11>2014 15:55 Apr 18, 2019 Jkt 247001 0.01 ppm; and Vegetable, legume, group 06 at 0.01 ppm. An independently validated analytical method is available to measure and evaluate the chemical Trifludimoxazin. Contact: FHB. Authority: 21 U.S.C. 346a. Dated: March 19, 2019. Delores Barber, Director, Information Technology and Resources Management Division, Office of Pesticide Programs. [FR Doc. 2019–07840 Filed 4–18–19; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 721 [EPA–HQ–OPPT–2018–0772; FRL–9992–42] RIN 2070–AB27 Significant New Use Rules on Certain Chemical Substances (19–1) Environmental Protection Agency (EPA). ACTION: Proposed rule. AGENCY: EPA is proposing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for 11 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 11 chemical substances for an activity that is designated as a significant new use by this proposed rule. If this proposed rule is made final, persons may 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, and has taken any actions as are required as a result of that determination. DATES: Comments must be received on or before May 20, 2019. ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA–HQ–OPPT–2018–0772, 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 SUMMARY: PO 00000 Frm 00018 Fmt 4702 Sfmt 4702 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 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, E:\FR\FM\19APP1.SGM 19APP1 Federal Register / Vol. 84, No. 76 / Friday, April 19, 2019 / Proposed Rules any persons who export or intend to export a chemical substance that is the subject of this proposed rule on or after May 20, 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. II. Background A. What action is the Agency taking? khammond on DSKBBV9HB2PROD with PROPOSALS EPA is proposing these SNURs under TSCA section 5(a)(2) for 11 chemical substances which were the subjects of PMNs P-14-482, P-16-422, P-17-152, P17-239, P-17-245, P-18-48, P-18-73, P18-122, P-18-162, P-18-222, and P-19-10. 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–2018–0772. That record includes information considered by the Agency in developing these proposed SNURs. Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a ‘‘significant new use.’’ EPA must make this determination by rule after considering all relevant factors, including the four bulleted TSCA 15:55 Apr 18, 2019 Jkt 247001 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 § 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 significant new use is not likely to present an unreasonable risk of injury 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 significant new 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 B. What is the Agency’s authority for taking this action? VerDate Sep<11>2014 section 5(a)(2) factors listed in Unit III. Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1)(B)(i) (15 U.S.C. 2604(a)(1)(B)(i)) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture or process the chemical substance for that use. TSCA prohibits such manufacturing or processing from commencing until EPA has conducted a review of the SNUN, made an appropriate determination on the SNUN, and taken such actions as are required in association with that determination (15 U.S.C. 2604(a)(1)(B)(ii)). As described in Unit V., the general SNUR provisions are found at 40 CFR part 721, subpart A. Section 5(a)(2) of TSCA states that EPA’s determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors, including: • The projected volume of manufacturing and processing of a chemical substance. PO 00000 Frm 00019 Fmt 4702 Sfmt 4702 16433 • The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance. • The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance. • The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance. In addition to these factors enumerated in TSCA section 5(a)(2), the statute authorizes EPA to consider any other relevant factors. To determine what would constitute significant new uses 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. IV. Substances Subject to This Proposed Rule EPA is proposing significant new use and recordkeeping requirements for 11 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 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 E:\FR\FM\19APP1.SGM 19APP1 16434 Federal Register / Vol. 84, No. 76 / Friday, April 19, 2019 / Proposed Rules khammond on DSKBBV9HB2PROD with PROPOSALS 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. EPA has initially determined under TSCA section 5(a)(2), 15 U.S.C. 2604(a)(2), that certain changes from the intended conditions of use described in the PMNs could result in changes in the type or form of exposure to the chemical substances and/or increased exposures to the chemical substances and/or changes in the reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of the chemical substances. Consequently, EPA is proposing to designate these changes as significant new uses. PMN Number: P-14-482 Chemical name: Organic salt (generic). CAS number: Not available. Basis for action: The PMNs state that the generic (non-confidential) use of the substance will be as an industrial chemical. Based on the physical/ chemical properties of the PMN substance and Structure Analysis Relationships (SAR) analysis of test data on analogous substances, EPA has identified concerns for developmental toxicity, neurotoxicity, skin sensitization, and aquatic toxicity at surface water concentrations exceeding 40 parts per billion (ppb), if the chemical substance is not used following the limitations noted. The conditions of use of the PMN substance as described in the PMN include the following protective measures: 1. No manufacture (including import) of an annual production volume of the PMN substance greater than the confidential amount stated in the PMN; 2. No use of the PMN substance other than the four confidential uses stated in the PMN; and 3. No manufacture, processing or use of the PMN substance in any manner that results in inhalation exposures. VerDate Sep<11>2014 15:55 Apr 18, 2019 Jkt 247001 The proposed SNUR would designate as a ‘‘significant new use’’ the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the aquatic and human health toxicity and environmental fate 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 fate, pulmonary effects, developmental toxicity, and aquatic toxicity testing would help characterize the potential health and environmental effects of the PMN substance. CFR citation: 40 CFR 721.11247. PMN Number: P-16-422 Chemical name: 1,2Cyclohexanedicarboxylic acid, 1(phenylmethyl) ester, ester with 2,2,4trimethyl-1,3-pentanediol mono(2methylpropanoate). CAS number: 1661012–65–2. Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an additive for polymers. Based on the physical/ chemical properties of the PMN substance, data on the PMN substance, and Structure Analysis Relationships (SAR) analysis of test data on analogous substances, EPA has identified concerns for irritation and sensitization, developmental toxicity, and aquatic toxicity at surface water concentrations exceeding 12 parts per billion (ppb), if the chemical substance is not used following the limitations noted. The conditions of use of the PMN substance as described in the PMN include the following protective measures: 1. No use of the PMN substance involving an application method that results in inhalation exposures; and 2. No release of a manufacturing, processing, or use stream associated with any use of the PMN substance, other than releases from the confidential polymer additive use described in the PMN, into the waters of the United States exceeding a surface water concentration of 12 ppb. The proposed SNUR would designate as a ‘‘significant new use’’ the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the aquatic and human health 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 PO 00000 Frm 00020 Fmt 4702 Sfmt 4702 SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that the results of developmental toxicity and aquatic toxicity testing would help characterize the potential health and environmental effects of the PMN substance. CFR citation: 40 CFR 721.11248. PMN Number: P-17-152 Chemical name: Poly-(2-methyl-1oxo-2-propen-1-yl) ester with ethanaminium, N,N,N-trialkyl, chloride and methoxypoly(oxy-1,2-ethanediyl) (generic). CAS number: Not available. Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an additive in home care products. Based on analogy to structurally similar substances, EPA has identified concerns for aquatic toxicity and lung effects if the chemical is not used following the limitations noted. The conditions of use of the PMN substance as described in the PMN include the following protective measures: 1. No manufacture, processing or use of the substance in any manner that results in inhalation exposures; 2. No manufacture or processing of the PMN substance as a powder or solid; and 3. No release of a manufacturing, processing, or use stream associated with any use of the PMN substance exceeding a surface water concentration of 1 ppb. The proposed SNUR would designate as a ‘‘significant new use’’ the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the 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 aquatic toxicity and pulmonary effects testing of the PMN substance may be potentially useful in characterizing the health and environmental effects of the PMN substance. CFR citation: 40 CFR 721.11249. PMN Number: P-17-239 Chemical name: Substituted carboxylic acid, polymer with 2,4diisocyanato-1-methylbenzene, hexanedioic acid, alpha-hydro-omegahydroxypoly[oxy(methyl-1,2ethanediyl)], 1,1′-methylenebis[4isocyanatobenzene], 2,2′- E:\FR\FM\19APP1.SGM 19APP1 Federal Register / Vol. 84, No. 76 / Friday, April 19, 2019 / Proposed Rules khammond on DSKBBV9HB2PROD with PROPOSALS oxybis[ethanol], 1,1′-oxybis[2-propanol] and 1,2-propanediol, (generic). CAS number: Not available. Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an adhesive for open non-descriptive use. Based on data for analogous compounds, EPA has identified concerns for irritation, sensitization, and oncogenicity if the chemical is not used following the limitations noted. The conditions of use of the PMN substance as described in the PMN include the following protective measures: 1. No use of the PMN substance involving spray application that results in inhalation exposures; 2. No release of a manufacturing, processing, or use stream associated with any use of the PMN substance exceeding a surface water concentration of 33 ppb; 3. No manufacturing, processing or use of the PMN substance for consumer use; and 4. No manufacture with unreacted isocyanate residual greater than 20% by weight. The proposed SNUR would designate as a ‘‘significant new use’’ the absence of these protective measures. 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 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 aquatic toxicity, mutagenicity, and sensitization testing would help characterize the potential health and environmental effects of the PMN substance. CFR citations: 40 CFR 721.11250. PMN Number: P-17-245 Chemical name: Unsaturated polyfluoro ester (generic). CAS number: Not available. Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an adhesive for open, non-dispersive use. Based on the physical/chemical properties of the PMN substance (as described in the New Chemical Program’s PBT category at 64 FR 60194; November 4, 1999) and test data on structurally similar substances, the PMN substance is potentially persistent, bioaccumulative, and toxic (PBT) chemical. EPA estimates that the PMN substance will persist in the environment for more than six months and estimates an unknown VerDate Sep<11>2014 15:55 Apr 18, 2019 Jkt 247001 bioaccumulation factor. EPA has identified concerns for irritation, respiratory sensitization, and mutagenicity if the chemical is not used following the limitations noted. The conditions of use of the PMN substance as described in the PMN include the following protective measures: 1. No releases of a manufacturing, processing, or use stream associated with any use of the PMN substance into the waters of the United States. 2. Use only for the confidential use stated in the PMN. 3. Dispose of the PMN substance and any waste streams containing the PMN substance or its constituent breakdown products only by sending them via a hazardous waste transporter to a hazardous waste incinerator permitted under the Resource Conservation and Recovery Act (RCRA) or an authorized state hazardous waste program. The proposed SNUR would designate as a ‘‘significant new use’’ the absence of these protective measures. 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 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 effect and sensitization assay testing would help characterize the potential health effects of the PMN substance. CFR citation: 40 CFR 721.11251. PMN Number: P-18-48 Chemical name: Acetic acid, 2-(2butoxyethoxy)-. CAS number: 82941–26–2. Basis for action: The PMN states that the use of the substance will be as an emulsifier for metal working fluid. Based on test data on the PMN substance and on test data on analogous chemical substances, EPA has identified concerns for developmental toxicity and corrosion if the chemical is not used following the limitations noted. The conditions of use of the PMN substance as described in the PMN include the following protective measure: • No manufacture, processing, or use of the PMN substance for uses other than as emulsifier for metal working fluid. The proposed SNUR would designate as a ‘‘significant new use’’ the absence of this protective measure. Potentially useful information: EPA has determined that certain information about the PMN substance may be potentially useful to characterize the PO 00000 Frm 00021 Fmt 4702 Sfmt 4702 16435 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 specific organ toxicity test and, reproductive/developmental toxicity test would help characterize the potential health effects of the PMN substance. CFR citation: 40 CFR 721.11252. PMN Number: P-18-73 Chemical name: Sulfuric acid, ammonium salt (1:?). CAS number: 10043–02–4. Basis for action: The PMN states that the generic use of the substance will be as a non-pesticide agricultural use chemical. Based on test data on the PMN substance and on test data on analogous chemical substances, EPA has identified concerns for liver, kidney, lung, and gastrointestinal effects and irritation/corrosion if the chemical is not used following the limitations noted. The conditions of use of the PMN substance as described in the PMN include the following protective measure: • Use only as a Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) inert ingredient, an anti-scalant, chlorine stabilizer, or the additional confidential uses stated in the PMN. The proposed SNUR would designate as a ‘‘significant new use’’ the absence of this protective measure. Potentially useful information: EPA has determined that certain information about 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 specific organ toxicity and skin irritation/corrosion testing would help characterize the potential health effects of the PMN substance. CFR citation: 40 CFR 721.11253. PMN Number: P-18-122 Chemical name: Alkylamide, polymer with alkylamine, formaldehyde, and polycyanamide, alkyl acid salt (generic). CAS number: Not available. Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a paper additive. Based on analogy to structurally similar substances, EPA has identified concerns for aquatic toxicity and irritation to skin, eyes and lungs, and lung toxicity if the chemical is not used following the limitations noted. The conditions of use E:\FR\FM\19APP1.SGM 19APP1 16436 Federal Register / Vol. 84, No. 76 / Friday, April 19, 2019 / Proposed Rules khammond on DSKBBV9HB2PROD with PROPOSALS of the PMN substance as described in the PMN include the following protective measures: • No release of a processing or use stream associated with any use of the substance, other than the releases from the intended conditions of use described in the PMN, into the water of the United States exceeding a surface water concentration of 1 ppb. The proposed SNUR would designate as a ‘‘significant new use’’ the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the fate and 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, aquatic toxicity,, skin irritation, eye irritation and corrosion, and pulmonary effects testing of the PMN substance may be potentially useful in characterizing the health and environmental effects of the PMN substance. CFR citation: 40 CFR 721.11254. PMN Number: P-18-162 Chemical name: Cashew nutshell liquid, polymer with diisocyanatoalkane, substitutedpolyoxyalkyldiol and polyether polyol (generic). CAS number: Not available. Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an adhesive component. Based on analogy to structurally similar substances, EPA has identified concerns for pulmonary effects if the chemical is not used following the limitations noted. The conditions of use of the PMN substance as described in the PMN include the following protective measure: • No manufacture (including import) the PMN substance in a form other than as a paste. The proposed SNUR would designate as a ‘‘significant new use’’ the absence of this protective measure. Potentially useful information: EPA has determined that certain information about the fate and 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 pulmonary effects testing of the PMN VerDate Sep<11>2014 15:55 Apr 18, 2019 Jkt 247001 substance may be potentially useful in characterizing the health and environmental effects of the PMN substance. CFR citation: 40 CFR 721.11255. PMN Number: P-18-222 Chemical name: Silane, alkenylalkoxy-, polymer with alkene and alkene (generic). CAS number: Not available. Basis for action: The PMN states that the use of the substance will be as a reactive polymer for use in adhesive applications. Based on analogy to structurally similar substances and data on the PMN substance, EPA has identified concerns for neurotoxicity and pulmonary effects if the chemical is not used following the limitations noted. The conditions of use of the PMN substance as described in the PMN include the following protective measure: • No manufacture, processing, or use of the PMN substance other than as a reactive polymer for use in adhesive applications. The proposed SNUR would designate as a ‘‘significant new use’’ the absence of this protective measure. Potentially useful information: EPA has determined that certain information about the fate and 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 absorption and neurotoxicity testing of the PMN substance may be potentially useful in characterizing the health and environmental effects of the PMN substance. CFR citation: 40 CFR 721.11256. PMN Number: P-19-10 Chemical name: Hydrogenated fatty acid dimers, polymers with 1,1′methylenebis[4-isocyanatobenzene], polypropylene glycol, polypropylene glycol ether with trimethylolpropane (3:1), and 1,3-propanediol, polypropylene glycol monomethacrylate-blocked (generic). CAS number: Not available. Basis for action: The PMN states that the generic use of the substance will be as an adhesive. Based on analogy to structurally similar isocyanates, EPA has identified concerns for irritation, sensitization, pulmonary toxicity, mutagenicity and carcinogenicity if the chemical is not used following the limitations noted. The conditions of use of the PMN substance as described in PO 00000 Frm 00022 Fmt 4702 Sfmt 4702 the PMN include the following protective measure: • No use involving an application method that results in inhalation exposures. The proposed SNUR would designate as a ‘‘significant new use’’ the absence of this protective measure. Potentially useful information: EPA has determined that certain information about the 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 sensitization, genetic toxicity, pulmonary effects, and eye damage testing of the PMN substance may be potentially useful in characterizing the health effects of the PMN substance. CFR citation: 40 CFR 721.11257. 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 reasonably foreseen changes from the conditions of use identified in the PMNs and determined that those changes could result in changes in the type or form of exposure to the chemical substances and/or increased exposures to the chemical substances and/or changes in the reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of the chemical substances. B. Objectives EPA is proposing SNURs for 11 specific chemical substances which are undergoing premanufacture review because the Agency wants to achieve the following objectives with regard to the significant new uses that would be designated in this proposed rule: • EPA would have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing or processing a listed chemical substance for the described significant new use. • EPA would 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 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 E:\FR\FM\19APP1.SGM 19APP1 Federal Register / Vol. 84, No. 76 / Friday, April 19, 2019 / Proposed Rules exposed or susceptible subpopulation identified as relevant by the Administrator under the conditions of use, or make a determination under 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. 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 http://www.epa.gov/opptintr/ existingchemicals/pubs/tscainventory/ index.html. khammond on DSKBBV9HB2PROD with PROPOSALS 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 this proposed SNUR, EPA concludes that the proposed significant new uses are not ongoing. EPA designates April 15, 2019 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. 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 VerDate Sep<11>2014 15:55 Apr 18, 2019 Jkt 247001 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 section 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. PO 00000 Frm 00023 Fmt 4702 Sfmt 4702 16437 • Information on risks posed by the chemical substances compared to risks posed by potential substitutes. 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–2018–0772. 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 11 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). 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. E:\FR\FM\19APP1.SGM 19APP1 16438 Federal Register / Vol. 84, No. 76 / Friday, April 19, 2019 / Proposed Rules khammond on DSKBBV9HB2PROD with PROPOSALS 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 Strategies Division, Office of Enterprise Information Programs (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 VerDate Sep<11>2014 15:55 Apr 18, 2019 Jkt 247001 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. 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. 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) 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). Environmental protection, Chemicals, Hazardous substances, Reporting and recordkeeping requirements. 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, PO 00000 Frm 00024 Fmt 4702 Sfmt 4702 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. 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 Dated: April 15, 2019. Tala Henry, Acting 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). 2. Add § 721.11247 to subpart E to read as follows: ■ § 721.11247 Organic salt (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as organic salt (PMN P-14482) 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 E:\FR\FM\19APP1.SGM 19APP1 Federal Register / Vol. 84, No. 76 / Friday, April 19, 2019 / Proposed Rules specified in § 721.80(j). It is a significant new use to manufacture, process or use the substance in any manner that results in inhalation exposures. It is a significant new use to exceed the confidential annual production volume stated in the PMN. (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) though (c) and (i), are applicable to manufacturers 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)(iii) of this section. ■ 3. Add § 721.11248 to subpart E to read as follows: khammond on DSKBBV9HB2PROD with PROPOSALS § 721.11248 1,2-Cyclohexanedicarboxylic acid, 1-(phenylmethyl) ester, ester with 2,2,4-trimethyl-1,3-pentanediol mono(2methylpropanoate). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1,2-Cyclohexanedicarboxylic acid, 1(phenylmethyl) ester, ester with 2,2,4trimethyl-1,3-pentanediol mono(2methylpropanoate) (P-16-422, CAS No. 1661012–65–2) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Industrial, Commercial, and consumer activities. It is a significant new use to use the substance involving an application method that results in inhalation exposures. It is a significant new use to release a manufacturing, processing, or use stream associated with any use of the substance, other than releases from the confidential polymer additive use described in the PMN, into the waters of the United States exceeding a surface water concentration of 12 part per billion (ppb) using the methods described in § 721.91. (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), (i), and (k) are applicable to manufacturers, importers, and processors of this substance. VerDate Sep<11>2014 15:55 Apr 18, 2019 Jkt 247001 (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section. ■ 4. Add § 721.11249 to subpart E to read as follows: § 721.11249 Poly-(2-methyl-1-oxo-2propen-1-yl) ester with ethanaminium, N,N,N-trialkyl, chloride and methoxypoly(oxy-1,2-ethanediyl) (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as poly-(2-methyl-1-oxo-2propen-1-yl) ester with ethanaminium, N,N,N-trialkyl, chloride and methoxypoly(oxy-1,2-ethanediyl) (P-17152) 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, process, or use the substance in any 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 = 1. (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. ■ 5. Add § 721.11250 to subpart E to read as follows: § 721.11250 Substituted carboxylic acid, polymer with 2,4-diisocyanato-1methylbenzene, hexanedioic acid, alphahydro-omega-hydroxypoly[oxy(methyl-1,2ethanediyl)], 1,1′-methylenebis[4isocyanatobenzene], 2,2′-oxybis[ethanol], 1,1′-oxybis[2-propanol] and 1,2propanediol, (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as substituted carboxylic acid, polymer with 2,4-diisocyanato-1methylbenzene, hexanedioic acid, alpha-hydro-omegahydroxypoly[oxy(methyl-1,2ethanediyl)], 1,1′-methylenebis[4isocyanatobenzene], 2,2′oxybis[ethanol], 1,1′-oxybis[2-propanol] and 1,2-propanediol), (P-17-239) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. PO 00000 Frm 00025 Fmt 4702 Sfmt 4702 16439 (2) The significant new uses are: (i) Industrial, Commercial, and consumer activities. Requirements as specified in § 721.80 (o). It is a significant new use to use the substance involving spray application that results in inhalation exposures. It is a significant new use to manufacture (includes importing) the substance to contain more than 20% residual isocyanate by weight. (ii) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) where N = 33. (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. ■ 6. Add § 721.11251 to subpart E to read as follows: § 721.11251 (generic). Unsaturated polyfluoro ester, (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically as unsaturated polyfluoro ester, (P–17– 245) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Release to water. Requirements as specified in § 721.90(a)(1), (b)(1), and (c)(1). (ii) Industrial, Commercial, and consumer activities. Requirements as specified in § 721.80 (j). (iii) Disposal. It is a significant new use to dispose of the substance and any waste streams containing the substance or its constituent breakdown products other than by sending them via a hazardous waste transporter to a hazardous waste incinerator permitted under the Resource Conservation and Recovery Act (RCRA) or an authorized state hazardous waste program. (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), (j) and (k) are applicable to manufacturers, importers, and processors of this substance. (2) Limitations or revocation of certain notification requirements. The E:\FR\FM\19APP1.SGM 19APP1 16440 Federal Register / Vol. 84, No. 76 / Friday, April 19, 2019 / Proposed Rules 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)(ii) of this section. ■ 7. Add § 721.11252 to subpart E to read as follows: § 721.11252 Acetic acid, 2-(2butoxyethoxy)-. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance with nonconfidential name as acetic acid, 2-(2butoxyethoxy)- (P-18-48, CAS No. 82941–26–2) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Industrial, Commercial, and consumer activities. It is a significant new use to use the substance other than as emulsifier for metal working fluid. (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. ■ 8. Add § 721.11253 to subpart E to read as follows: khammond on DSKBBV9HB2PROD with PROPOSALS § 721.11253 (1:?). Sulfuric acid, ammonium salt (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as organic salt (PMN P-18-73, CAS No. 10043–02–4) 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 use the substance other than a Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) inert ingredient, an anti-scalant, a chlorine stablizer, or the additional confidential uses described in the PMN. (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 VerDate Sep<11>2014 15:55 Apr 18, 2019 Jkt 247001 § 721.125(a) thru (c) and (i), are applicable to manufacturers 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)(iii) of this section. ■ 9. Add § 721.11254 to subpart E to read as follows: § 721.11254 Alkylamide, polymer with alkylamine, formaldehyde, and polycyanamide, alkyl acid salt (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as alkylamide, polymer with alkylamine, formaldehyde, and polycyanamide, alkyl acid salt (P-18122) 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 release a manufacturing, processing, or use stream associated with any use of the substances, other than the confidential chemical intermediate use described in the premanufacture notices, into the waters of the United States exceeding a surface water concentration of 1 part per billion (ppb) using the methods described in § 721.91. (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), (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. ■ 10. Add § 721.11255 to subpart E to read as follows: § 721.11255 Cashew nutshell liquid, polymer with diisocyanatoalkane, substituted-polyoxyalkyldiol and polyether polyol (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as Cashew nutshell liquid, polymer with diisocyanatoalkane, substituted-polyoxyalkyldiol and polyether polyol (P-18-162) is subject to reporting under this section for the PO 00000 Frm 00026 Fmt 4702 Sfmt 4702 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 (including import) in a form other that as a paste. (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. ■ 11. Add § 721.11256 to subpart E to read as follows: § 721.11256 Silane, alkenylalkoxy-, polymer with alkene and alkene (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as silane, alkenylalkoxy-, polymer with alkene and alkene (P-18222) 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, process, or use the substance for uses other than as a reactive polymer for use in adhesive applications. (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. ■ 12. Add § 721.11257 to subpart E to read as follows: § 721.11257 Hydrogenated fatty acid dimers, polymers with 1,1′-methylenebis[4isocyanatobenzene], polypropylene glycol, polypropylene glycol ether with trimethylolpropane (3:1), and 1,3propanediol, polypropylene glycol monomethacrylate-blocked. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as hydrogenated fatty acid E:\FR\FM\19APP1.SGM 19APP1 Federal Register / Vol. 84, No. 76 / Friday, April 19, 2019 / Proposed Rules dimers, polymers with 1,1′methylenebis[4-isocyanatobenzene], polypropylene glycol, polypropylene glycol ether with trimethylolpropane (3:1), and 1,3-propanediol, polypropylene glycol monomethacrylate-blocked (P-19-10) 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 use the substance involving an application method that results in inhalation exposures. (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. [FR Doc. 2019–07853 Filed 4–18–19; 8:45 am] to the Federal Acquisition Regulation (FAR). This proposed revision would have updated, clarified and streamlined text in certain DOE intellectual property and technology transfer clauses in order to benefit from DOE’s experience under the existing clauses, and, where necessary, make these DOE clauses consistent with recent changes to the FAR. However, the Department has determined that it will not proceed with the rulemaking and, as such, is withdrawing the proposed rule. The changes that were proposed in this rulemaking will be incorporated into a larger rulemaking that will update the entire Department of Energy Acquisition Regulation (DEAR). Signed in Washington, DC, on March 26, 2019. John Bashista, Director, Office of Acquisition Management, Department of Energy. [FR Doc. 2019–07913 Filed 4–18–19; 8:45 am] BILLING CODE 6450–01–P DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration BILLING CODE 6560–50–P 50 CFR Part 648 [Docket No. 181203999–9350–01] DEPARTMENT OF ENERGY RIN 0648–BI64 48 CFR Parts 927, 952, and 970 RIN 1991–AB82 Acquisition Regulation: Patents, Data and Copyrights Department of Energy. Notice of proposed rulemaking; withdrawal. AGENCY: ACTION: On November 7, 2013, the U.S. Department of Energy (DOE) published a rule in the Federal Register proposing to amend the Department of Energy Acquisition Regulation (DEAR). DOE hereby withdraws this proposed rule. SUMMARY: The proposed rule that appeared in the Federal Register on November 7, 2013 (78 FR 66865) is withdrawn as of April 19, 2019. FOR FURTHER INFORMATION CONTACT: Sharon Archer, U.S. Department of Energy, Office of Acquisition Management, MA–611, 950 L’Enfant Plaza SW, Washington, DC 20024. Telephone: (202) 287–1739. Email: Sharon.Archer@hq.doe.gov. SUPPLEMENTARY INFORMATION: On November 3, 2013, the U.S. Department of Energy (DOE) published a rule proposing to make changes to conform khammond on DSKBBV9HB2PROD with PROPOSALS DATES: VerDate Sep<11>2014 15:55 Apr 18, 2019 Jkt 247001 Magnuson-Stevens Fishery Conservation and Management Act Provisions; Fisheries of the Northeastern United States; Northeast Multispecies Fishery; Framework Adjustment 58 National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Proposed rule; request for comments. AGENCY: This action proposes to approve and implement Framework Adjustment 58 to the Northeast Multispecies Fishery Management Plan. This rule would set 2019–2020 catch limits for 7 of the 20 multispecies (groundfish) stocks, implement new or revised rebuilding plans for 5 stocks, revise an accountability measure, and make other minor changes to groundfish management measures. This action is necessary to respond to updated scientific information and to achieve the goals and objectives of the fishery management plan. The proposed measures are intended to help prevent overfishing, rebuild overfished stocks, achieve optimum yield, and ensure that SUMMARY: PO 00000 Frm 00027 Fmt 4702 Sfmt 4702 16441 management measures are based on the best scientific information available. DATES: Comments must be received by May 6, 2019. ADDRESSES: You may submit comments, identified by NOAA–NMFS–2018–0138, by either of the following methods: • Electronic Submission: Submit all electronic public comments via the Federal eRulemaking Portal. 1. Go to www.regulations.gov/ #!docketDetail;D=NOAA-NMFS-20180138; 2. Click the ‘‘Comment Now!’’ icon and complete the required fields; and 3. Enter or attach your comments. • Mail: Submit written comments to Michael Pentony, Regional Administrator, National Marine Fisheries Service, 55 Great Republic Drive, Gloucester, MA 01930. Mark the outside of the envelope, ‘‘Comments on the Proposed Rule for Groundfish Framework Adjustment 58.’’ Instructions: Comments sent by any other method, to any other address or individual, or received after the end of the comment period, may not be considered by us. All comments received are a part of the public record and will generally be posted for public viewing on www.regulations.gov without change. All personal identifying information (e.g., name, address, etc.), confidential business information, or otherwise sensitive information submitted voluntarily by the sender will be publicly accessible. We will accept anonymous comments (enter ‘‘N/A’’ in the required fields if you wish to remain anonymous). Copies of Framework Adjustment 58, including the draft Environmental Assessment, the Regulatory Impact Review, and the Regulatory Flexibility Act Analysis prepared by the New England Fishery Management Council in support of this action are available from Thomas A. Nies, Executive Director, New England Fishery Management Council, 50 Water Street, Mill 2, Newburyport, MA 01950. The supporting documents are also accessible via the internet at: http:// www.nefmc.org/management-plans/ northeast-multispecies or http:// www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Mark Grant, Fishery Policy Analyst, phone: 978–281–9145; email: Mark.Grant@noaa.gov. SUPPLEMENTARY INFORMATION: Table of Contents 1. Summary of Proposed Measures 2. Fishing Year 2019–2020 Shared U.S./ Canada Quotas 3. Catch Limits for Fishing Years 2019–2020 E:\FR\FM\19APP1.SGM 19APP1

Agencies

[Federal Register Volume 84, Number 76 (Friday, April 19, 2019)]
[Proposed Rules]
[Pages 16432-16441]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-07853]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2018-0772; FRL-9992-42]
RIN 2070-AB27


Significant New Use Rules on Certain Chemical Substances (19-1)

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 11 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 11 chemical substances for an activity that is designated as a 
significant new use by this proposed rule. If this proposed rule is 
made final, persons may 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, and has taken any actions as 
are required as a result of that determination.

DATES: Comments must be received on or before May 20, 2019.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2018-0772, 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,

[[Page 16433]]

any persons who export or intend to export a chemical substance that is 
the subject of this proposed rule on or after May 20, 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.

II. Background

A. What action is the Agency taking?

    EPA is proposing these SNURs under TSCA section 5(a)(2) for 11 
chemical substances which were the subjects of PMNs P-14-482, P-16-422, 
P-17-152, P-17-239, P-17-245, P-18-48, P-18-73, P-18-122, P-18-162, P-
18-222, and P-19-10. 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-2018-0772. That record includes 
information considered by the Agency in developing these proposed 
SNURs.

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

    Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to 
determine that a use of a chemical substance is a ``significant new 
use.'' EPA must make this determination by rule after considering all 
relevant factors, including the four bulleted TSCA section 5(a)(2) 
factors listed in Unit III. Once EPA determines that a use of a 
chemical substance is a significant new use, TSCA section 5(a)(1)(B)(i) 
(15 U.S.C. 2604(a)(1)(B)(i)) requires persons to submit a significant 
new use notice (SNUN) to EPA at least 90 days before they manufacture 
or process the chemical substance for that use. TSCA prohibits such 
manufacturing or processing from commencing until EPA has conducted a 
review of the SNUN, made an appropriate determination on the SNUN, and 
taken such actions as are required in association with that 
determination (15 U.S.C. 2604(a)(1)(B)(ii)). 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 
Sec.  721.1(c), persons subject to these SNURs must comply with the 
same SNUN requirements and EPA regulatory procedures as submitters of 
PMNs under TSCA section 5(a)(1)(A) (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 
significant new use is not likely to present an unreasonable risk of 
injury 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 
significant new 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

    Section 5(a)(2) of TSCA states that EPA's determination that a use 
of a chemical substance is a significant new use must be made after 
consideration of all relevant factors, including:
     The projected volume of manufacturing and processing of a 
chemical substance.
     The extent to which a use changes the type or form of 
exposure of human beings or the environment to a chemical substance.
     The extent to which a use increases the magnitude and 
duration of exposure of human beings or the environment to a chemical 
substance.
     The reasonably anticipated manner and methods of 
manufacturing, processing, distribution in commerce, and disposal of a 
chemical substance.
    In addition to these factors enumerated in TSCA section 5(a)(2), 
the statute authorizes EPA to consider any other relevant factors.
    To determine what would constitute significant new uses 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.

IV. Substances Subject to This Proposed Rule

    EPA is proposing significant new use and recordkeeping requirements 
for 11 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

[[Page 16434]]

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. EPA has initially 
determined under TSCA section 5(a)(2), 15 U.S.C. 2604(a)(2), that 
certain changes from the intended conditions of use described in the 
PMNs could result in changes in the type or form of exposure to the 
chemical substances and/or increased exposures to the chemical 
substances and/or changes in the reasonably anticipated manner and 
methods of manufacturing, processing, distribution in commerce, and 
disposal of the chemical substances. Consequently, EPA is proposing to 
designate these changes as significant new uses.

PMN Number: P-14-482

    Chemical name: Organic salt (generic).
    CAS number: Not available.
    Basis for action: The PMNs state that the generic (non-
confidential) use of the substance will be as an industrial chemical. 
Based on the physical/chemical properties of the PMN substance and 
Structure Analysis Relationships (SAR) analysis of test data on 
analogous substances, EPA has identified concerns for developmental 
toxicity, neurotoxicity, skin sensitization, and aquatic toxicity at 
surface water concentrations exceeding 40 parts per billion (ppb), if 
the chemical substance is not used following the limitations noted. The 
conditions of use of the PMN substance as described in the PMN include 
the following protective measures:
    1. No manufacture (including import) of an annual production volume 
of the PMN substance greater than the confidential amount stated in the 
PMN;
    2. No use of the PMN substance other than the four confidential 
uses stated in the PMN; and
    3. No manufacture, processing or use of the PMN substance in any 
manner that results in inhalation exposures.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the aquatic and human health toxicity and 
environmental fate 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 fate, pulmonary effects, 
developmental toxicity, and aquatic toxicity testing would help 
characterize the potential health and environmental effects of the PMN 
substance.
    CFR citation: 40 CFR 721.11247.

PMN Number: P-16-422

    Chemical name: 1,2-Cyclohexanedicarboxylic acid, 1-(phenylmethyl) 
ester, ester with 2,2,4-trimethyl-1,3-pentanediol mono(2-
methylpropanoate).
    CAS number: 1661012-65-2.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an additive for polymers. 
Based on the physical/chemical properties of the PMN substance, data on 
the PMN substance, and Structure Analysis Relationships (SAR) analysis 
of test data on analogous substances, EPA has identified concerns for 
irritation and sensitization, developmental toxicity, and aquatic 
toxicity at surface water concentrations exceeding 12 parts per billion 
(ppb), if the chemical substance is not used following the limitations 
noted. The conditions of use of the PMN substance as described in the 
PMN include the following protective measures:
    1. No use of the PMN substance involving an application method that 
results in inhalation exposures; and
    2. No release of a manufacturing, processing, or use stream 
associated with any use of the PMN substance, other than releases from 
the confidential polymer additive use described in the PMN, into the 
waters of the United States exceeding a surface water concentration of 
12 ppb.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the aquatic and human health 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 developmental toxicity and aquatic toxicity testing 
would help characterize the potential health and environmental effects 
of the PMN substance.
    CFR citation: 40 CFR 721.11248.

PMN Number: P-17-152

    Chemical name: Poly-(2-methyl-1-oxo-2-propen-1-yl) ester with 
ethanaminium, N,N,N-trialkyl, chloride and methoxypoly(oxy-1,2-
ethanediyl) (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an additive in home care 
products. Based on analogy to structurally similar substances, EPA has 
identified concerns for aquatic toxicity and lung effects if the 
chemical is not used following the limitations noted. The conditions of 
use of the PMN substance as described in the PMN include the following 
protective measures:
    1. No manufacture, processing or use of the substance in any manner 
that results in inhalation exposures;
    2. No manufacture or processing of the PMN substance as a powder or 
solid; and
    3. No release of a manufacturing, processing, or use stream 
associated with any use of the PMN substance exceeding a surface water 
concentration of 1 ppb.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the 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 aquatic toxicity 
and pulmonary effects testing of the PMN substance may be potentially 
useful in characterizing the health and environmental effects of the 
PMN substance.
    CFR citation: 40 CFR 721.11249.

PMN Number: P-17-239

    Chemical name: Substituted carboxylic acid, polymer with 2,4-
diisocyanato-1-methylbenzene, hexanedioic acid, alpha-hydro-omega-
hydroxypoly[oxy(methyl-1,2-ethanediyl)], 1,1'-methylenebis[4-
isocyanatobenzene], 2,2'-

[[Page 16435]]

oxybis[ethanol], 1,1'-oxybis[2-propanol] and 1,2-propanediol, 
(generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an adhesive for open non-
descriptive use. Based on data for analogous compounds, EPA has 
identified concerns for irritation, sensitization, and oncogenicity if 
the chemical is not used following the limitations noted. The 
conditions of use of the PMN substance as described in the PMN include 
the following protective measures:
    1. No use of the PMN substance involving spray application that 
results in inhalation exposures;
    2. No release of a manufacturing, processing, or use stream 
associated with any use of the PMN substance exceeding a surface water 
concentration of 33 ppb;
    3. No manufacturing, processing or use of the PMN substance for 
consumer use; and
    4. No manufacture with unreacted isocyanate residual greater than 
20% by weight.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    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 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 aquatic 
toxicity, mutagenicity, and sensitization testing would help 
characterize the potential health and environmental effects of the PMN 
substance.
    CFR citations: 40 CFR 721.11250.

PMN Number: P-17-245

    Chemical name: Unsaturated polyfluoro ester (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an adhesive for open, 
non-dispersive use. Based on the physical/chemical properties of the 
PMN substance (as described in the New Chemical Program's PBT category 
at 64 FR 60194; November 4, 1999) and test data on structurally similar 
substances, the PMN substance is potentially persistent, 
bioaccumulative, and toxic (PBT) chemical. EPA estimates that the PMN 
substance will persist in the environment for more than six months and 
estimates an unknown bioaccumulation factor. EPA has identified 
concerns for irritation, respiratory sensitization, and mutagenicity if 
the chemical is not used following the limitations noted. The 
conditions of use of the PMN substance as described in the PMN include 
the following protective measures:
    1. No releases of a manufacturing, processing, or use stream 
associated with any use of the PMN substance into the waters of the 
United States.
    2. Use only for the confidential use stated in the PMN.
    3. Dispose of the PMN substance and any waste streams containing 
the PMN substance or its constituent breakdown products only by sending 
them via a hazardous waste transporter to a hazardous waste incinerator 
permitted under the Resource Conservation and Recovery Act (RCRA) or an 
authorized state hazardous waste program.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    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 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 effect and sensitization 
assay testing would help characterize the potential health effects of 
the PMN substance.
    CFR citation: 40 CFR 721.11251.

PMN Number: P-18-48

    Chemical name: Acetic acid, 2-(2-butoxyethoxy)-.
    CAS number: 82941-26-2.
    Basis for action: The PMN states that the use of the substance will 
be as an emulsifier for metal working fluid. Based on test data on the 
PMN substance and on test data on analogous chemical substances, EPA 
has identified concerns for developmental toxicity and corrosion if the 
chemical is not used following the limitations noted. The conditions of 
use of the PMN substance as described in the PMN include the following 
protective measure:
     No manufacture, processing, or use of the PMN substance 
for uses other than as emulsifier for metal working fluid.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of this protective measure.
    Potentially useful information: EPA has determined that certain 
information about 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 specific organ toxicity test and, reproductive/
developmental toxicity test would help characterize the potential 
health effects of the PMN substance.
    CFR citation: 40 CFR 721.11252.

PMN Number: P-18-73

    Chemical name: Sulfuric acid, ammonium salt (1:?).
    CAS number: 10043-02-4.
    Basis for action: The PMN states that the generic use of the 
substance will be as a non-pesticide agricultural use chemical. Based 
on test data on the PMN substance and on test data on analogous 
chemical substances, EPA has identified concerns for liver, kidney, 
lung, and gastrointestinal effects and irritation/corrosion if the 
chemical is not used following the limitations noted. The conditions of 
use of the PMN substance as described in the PMN include the following 
protective measure:
     Use only as a Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA) inert ingredient, an anti-scalant, chlorine 
stabilizer, or the additional confidential uses stated in the PMN.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of this protective measure.
    Potentially useful information: EPA has determined that certain 
information about 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 specific organ toxicity and skin irritation/corrosion 
testing would help characterize the potential health effects of the PMN 
substance.
    CFR citation: 40 CFR 721.11253.

PMN Number: P-18-122

    Chemical name: Alkylamide, polymer with alkylamine, formaldehyde, 
and polycyanamide, alkyl acid salt (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a paper additive. Based 
on analogy to structurally similar substances, EPA has identified 
concerns for aquatic toxicity and irritation to skin, eyes and lungs, 
and lung toxicity if the chemical is not used following the limitations 
noted. The conditions of use

[[Page 16436]]

of the PMN substance as described in the PMN include the following 
protective measures:
     No release of a processing or use stream associated with 
any use of the substance, other than the releases from the intended 
conditions of use described in the PMN, into the water of the United 
States exceeding a surface water concentration of 1 ppb.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the fate and 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, aquatic 
toxicity,, skin irritation, eye irritation and corrosion, and pulmonary 
effects testing of the PMN substance may be potentially useful in 
characterizing the health and environmental effects of the PMN 
substance.
    CFR citation: 40 CFR 721.11254.

PMN Number: P-18-162

    Chemical name: Cashew nutshell liquid, polymer with 
diisocyanatoalkane, substituted-polyoxyalkyldiol and polyether polyol 
(generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an adhesive component. 
Based on analogy to structurally similar substances, EPA has identified 
concerns for pulmonary effects if the chemical is not used following 
the limitations noted. The conditions of use of the PMN substance as 
described in the PMN include the following protective measure:
     No manufacture (including import) the PMN substance in a 
form other than as a paste.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of this protective measure.
    Potentially useful information: EPA has determined that certain 
information about the fate and 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 pulmonary 
effects testing of the PMN substance may be potentially useful in 
characterizing the health and environmental effects of the PMN 
substance.
    CFR citation: 40 CFR 721.11255.

PMN Number: P-18-222

    Chemical name: Silane, alkenylalkoxy-, polymer with alkene and 
alkene (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the use of the substance will 
be as a reactive polymer for use in adhesive applications. Based on 
analogy to structurally similar substances and data on the PMN 
substance, EPA has identified concerns for neurotoxicity and pulmonary 
effects if the chemical is not used following the limitations noted. 
The conditions of use of the PMN substance as described in the PMN 
include the following protective measure:
     No manufacture, processing, or use of the PMN substance 
other than as a reactive polymer for use in adhesive applications.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of this protective measure.
    Potentially useful information: EPA has determined that certain 
information about the fate and 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 absorption 
and neurotoxicity testing of the PMN substance may be potentially 
useful in characterizing the health and environmental effects of the 
PMN substance.
    CFR citation: 40 CFR 721.11256.

PMN Number: P-19-10

    Chemical name: Hydrogenated fatty acid dimers, polymers with 1,1'-
methylenebis[4-isocyanatobenzene], polypropylene glycol, polypropylene 
glycol ether with trimethylolpropane (3:1), and 1,3-propanediol, 
polypropylene glycol monomethacrylate-blocked (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic use of the 
substance will be as an adhesive. Based on analogy to structurally 
similar isocyanates, EPA has identified concerns for irritation, 
sensitization, pulmonary toxicity, mutagenicity and carcinogenicity if 
the chemical is not used following the limitations noted. The 
conditions of use of the PMN substance as described in the PMN include 
the following protective measure:
     No use involving an application method that results in 
inhalation exposures.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of this protective measure.
    Potentially useful information: EPA has determined that certain 
information about the 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 sensitization, genetic 
toxicity, pulmonary effects, and eye damage testing of the PMN 
substance may be potentially useful in characterizing the health 
effects of the PMN substance.
    CFR citation: 40 CFR 721.11257.

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 reasonably foreseen changes from the 
conditions of use identified in the PMNs and determined that those 
changes could result in changes in the type or form of exposure to the 
chemical substances and/or increased exposures to the chemical 
substances and/or changes in the reasonably anticipated manner and 
methods of manufacturing, processing, distribution in commerce, and 
disposal of the chemical substances.

B. Objectives

    EPA is proposing SNURs for 11 specific chemical substances which 
are undergoing premanufacture review because the Agency wants to 
achieve the following objectives with regard to the significant new 
uses that would be designated in this proposed rule:
     EPA would have an opportunity to review and evaluate data 
submitted in a SNUN before the notice submitter begins manufacturing or 
processing a listed chemical substance for the described significant 
new use.
     EPA would 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 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

[[Page 16437]]

exposed or susceptible subpopulation identified as relevant by the 
Administrator under the conditions of use, or make a determination 
under 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.
    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 http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.

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 this proposed SNUR, EPA concludes 
that the proposed significant new uses are not ongoing.
    EPA designates April 15, 2019 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.

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 section 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.
     Information on risks posed by the chemical substances 
compared to risks posed by potential substitutes.

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-
2018-0772.

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 11 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).

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.

[[Page 16438]]

    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 Strategies Division, Office of Enterprise Information 
Programs (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: April 15, 2019.
Tala Henry,
Acting 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).

0
2. Add Sec.  721.11247 to subpart E to read as follows:


Sec.  721.11247   Organic salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as organic 
salt (PMN P-14-482) 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

[[Page 16439]]

specified in Sec.  721.80(j). It is a significant new use to 
manufacture, process or use the substance in any manner that results in 
inhalation exposures. It is a significant new use to exceed the 
confidential annual production volume stated in the PMN.
    (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) though (c) and (i), are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.
0
3. Add Sec.  721.11248 to subpart E to read as follows:


Sec.  721.11248   1,2-Cyclohexanedicarboxylic acid, 1-(phenylmethyl) 
ester, ester with 2,2,4-trimethyl-1,3-pentanediol mono(2-
methylpropanoate).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1,2-
Cyclohexanedicarboxylic acid, 1-(phenylmethyl) ester, ester with 2,2,4-
trimethyl-1,3-pentanediol mono(2-methylpropanoate) (P-16-422, CAS No. 
1661012-65-2) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, Commercial, and consumer activities. It is a 
significant new use to use the substance involving an application 
method that results in inhalation exposures. It is a significant new 
use to release a manufacturing, processing, or use stream associated 
with any use of the substance, other than releases from the 
confidential polymer additive use described in the PMN, into the waters 
of the United States exceeding a surface water concentration of 12 part 
per billion (ppb) using the methods described in Sec.  721.91.
    (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), (i), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
0
4. Add Sec.  721.11249 to subpart E to read as follows:


Sec.  721.11249   Poly-(2-methyl-1-oxo-2-propen-1-yl) ester with 
ethanaminium, N,N,N-trialkyl, chloride and methoxypoly(oxy-1,2-
ethanediyl) (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as poly-
(2-methyl-1-oxo-2-propen-1-yl) ester with ethanaminium, N,N,N-trialkyl, 
chloride and methoxypoly(oxy-1,2-ethanediyl) (P-17-152) 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, process, or use the substance in 
any 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 = 1.
    (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.
0
5. Add Sec.  721.11250 to subpart E to read as follows:


Sec.  721.11250   Substituted carboxylic acid, polymer with 2,4-
diisocyanato-1-methylbenzene, hexanedioic acid, alpha-hydro-omega-
hydroxypoly[oxy(methyl-1,2-ethanediyl)], 1,1'-methylenebis[4-
isocyanatobenzene], 2,2'-oxybis[ethanol], 1,1'-oxybis[2-propanol] and 
1,2-propanediol, (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
substituted carboxylic acid, polymer with 2,4-diisocyanato-1-
methylbenzene, hexanedioic acid, alpha-hydro-omega-
hydroxypoly[oxy(methyl-1,2-ethanediyl)], 1,1'-methylenebis[4-
isocyanatobenzene], 2,2'-oxybis[ethanol], 1,1'-oxybis[2-propanol] and 
1,2-propanediol), (P-17-239) is subject to reporting under this section 
for the significant new uses described in paragraph (a)(2) of this 
section.
    (2) The significant new uses are:
    (i) Industrial, Commercial, and consumer activities. Requirements 
as specified in Sec.  721.80 (o). It is a significant new use to use 
the substance involving spray application that results in inhalation 
exposures. It is a significant new use to manufacture (includes 
importing) the substance to contain more than 20% residual isocyanate 
by weight.
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N = 33.
    (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.
0
6. Add Sec.  721.11251 to subpart E to read as follows:


Sec.  721.11251   Unsaturated polyfluoro ester, (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically as unsaturated 
polyfluoro ester, (P-17-245) is subject to reporting under this section 
for the significant new uses described in paragraph (a)(2) of this 
section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(1).
    (ii) Industrial, Commercial, and consumer activities. Requirements 
as specified in Sec.  721.80 (j).
    (iii) Disposal. It is a significant new use to dispose of the 
substance and any waste streams containing the substance or its 
constituent breakdown products other than by sending them via a 
hazardous waste transporter to a hazardous waste incinerator permitted 
under the Resource Conservation and Recovery Act (RCRA) or an 
authorized state hazardous waste program.
    (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), (j) and (k) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The

[[Page 16440]]

provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(ii) of 
this section.
0
7. Add Sec.  721.11252 to subpart E to read as follows:


Sec.  721.11252   Acetic acid, 2-(2-butoxyethoxy)-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance with non-confidential name as 
acetic acid, 2-(2-butoxyethoxy)- (P-18-48, CAS No. 82941-26-2) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, Commercial, and consumer activities. It is a 
significant new use to use the substance other than as emulsifier for 
metal working fluid.
    (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.
0
8. Add Sec.  721.11253 to subpart E to read as follows:


Sec.  721.11253   Sulfuric acid, ammonium salt (1:?).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as organic salt (PMN 
P-18-73, CAS No. 10043-02-4) 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 use 
the substance other than a Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA) inert ingredient, an anti-scalant, a chlorine 
stablizer, or the additional confidential uses described in the PMN.
    (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) thru (c) and (i), are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.
0
9. Add Sec.  721.11254 to subpart E to read as follows:


Sec.  721.11254   Alkylamide, polymer with alkylamine, formaldehyde, 
and polycyanamide, alkyl acid salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
alkylamide, polymer with alkylamine, formaldehyde, and polycyanamide, 
alkyl acid salt (P-18-122) 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 release a manufacturing, processing, or use 
stream associated with any use of the substances, other than the 
confidential chemical intermediate use described in the premanufacture 
notices, into the waters of the United States exceeding a surface water 
concentration of 1 part per billion (ppb) using the methods described 
in Sec.  721.91.
    (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), (i), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
0
10. Add Sec.  721.11255 to subpart E to read as follows:


Sec.  721.11255   Cashew nutshell liquid, polymer with 
diisocyanatoalkane, substituted-polyoxyalkyldiol and polyether polyol 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as Cashew 
nutshell liquid, polymer with diisocyanatoalkane, substituted-
polyoxyalkyldiol and polyether polyol (P-18-162) 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 (including import) in a form other 
that as a paste.
    (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.
0
11. Add Sec.  721.11256 to subpart E to read as follows:


Sec.  721.11256   Silane, alkenylalkoxy-, polymer with alkene and 
alkene (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as silane, 
alkenylalkoxy-, polymer with alkene and alkene (P-18-222) 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, process, or use the substance for 
uses other than as a reactive polymer for use in adhesive applications.
    (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.
0
12. Add Sec.  721.11257 to subpart E to read as follows:


Sec.  721.11257   Hydrogenated fatty acid dimers, polymers with 1,1'-
methylenebis[4-isocyanatobenzene], polypropylene glycol, polypropylene 
glycol ether with trimethylolpropane (3:1), and 1,3-propanediol, 
polypropylene glycol monomethacrylate-blocked.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
hydrogenated fatty acid

[[Page 16441]]

dimers, polymers with 1,1'-methylenebis[4-isocyanatobenzene], 
polypropylene glycol, polypropylene glycol ether with 
trimethylolpropane (3:1), and 1,3-propanediol, polypropylene glycol 
monomethacrylate-blocked (P-19-10) 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 use the substance involving an application 
method that results in inhalation exposures.
    (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.

[FR Doc. 2019-07853 Filed 4-18-19; 8:45 am]
 BILLING CODE 6560-50-P