Source: https://www.federalregister.gov/documents/2019/11/04/2019-23388/significant-new-use-rules-on-certain-chemical-substances-19-4f
Timestamp: 2019-12-06 20:24:55
Document Index: 252790481

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Federal Register :: Significant New Use Rules on Certain Chemical Substances (19-4.F)
A Proposed Rule by the Environmental Protection Agency on 11/04/2019
59335-59349 (15 pages)
EPA-HQ-OPPT-2019-0494
FRL-10000-54
PMN Number: P-16-548
PMN Numbers: P-17-312, P-17-313, P-17-314, P-17-315, P-17-316, and P-17-317
PMN Numbers: P-17-398, P-17-399, P-18-1, and P-18-28
PMN Number: P-18-9
PMN Number: P-18-11
PMN Number: P-18-170
PMN Number: P-18-185
PMN Numbers: P-18-190 and P-18-191
PMN Number: P-18-223
PMN Number: P-18-285
PMN Number: P-18-300
PMN Number: P-18-394
PMN Number: P-18-404
PMN Number: P-19-12
PMN Number: P-19-31
PMN Number: P-19-71
PMN Number: P-19-72
E. Executive Order 11632: Federalism
https://www.federalregister.gov/d/2019-23388 https://www.federalregister.gov/d/2019-23388
EPA is proposing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for 26 chemical substances which were the subject of premanufacture notices (PMNs). Five of these chemical substances are subject to Orders issued by EPA pursuant to TSCA, and the remaining 21 of these chemical substances received a “not likely to present an unreasonable risk” determination pursuant to TSCA. This action would require persons who intend to manufacture (defined by statute to include import) or process any of these 26 chemical substances for an activity that is proposed as a significant new use to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA's evaluation of the use, under the conditions of use for that chemical substance, within the applicable review period. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required by that determination.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2019-0494, by one of the following methods:
Manufacturers or processors of one or more subject chemical substances Start Printed Page 59336(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 final SNURs must certify their compliance with the SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export a chemical substance that is the subject of this proposed rule on or after December 4, 2019 are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see 40 CFR 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D.
EPA is proposing these SNURs under TSCA section 5(a)(2) for chemical substances that were the subject of PMNs. These proposed SNURs would require persons to notify EPA at least 90 days before commencing the manufacture or processing of a chemical substance for any activity proposed as a significant new use. Receipt of such notices would allow EPA to assess risks and, if appropriate, to regulate the significant new use before it may occur. Additional background regarding SNURs is more fully set out in the preamble to EPA's first direct final SNUR published in the Federal Register issue of April 24, 1990 (55 FR 17376). Consult that preamble for further general information on the objectives, rationale, and procedures for SNURs and on the basis for significant new use designations, including provisions for developing test data.
TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a “significant new use.” EPA must make this determination by rule after considering all relevant factors, including the four bulleted TSCA section 5(a)(2) factors listed in Unit III.
General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to the proposed rule, recordkeeping requirements, and exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the rule. Provisions relating to user fees appear at 40 CFR part 700. Pursuant to 40 CFR 721.1(c), persons subject to 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 section 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA must either determine that the use is not likely to present an unreasonable risk of injury under the conditions of use for the chemical substance or take such regulatory action as is associated with an alternative determination before the manufacture or processing for the significant new use can commence. In the case of a determination other than not likely to present unreasonable risk, the applicable review period must also expire before manufacturing or processing for the new use may commence. If EPA determines that the use is not likely to present an unreasonable risk, EPA is required under TSCA section 5(g) to make public, and submit for publication in the Federal Register, a statement of EPA's findings.
In determining significant new uses for the 26 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 substances, in addition to the factors in TSCA section 5(a)(2). Consistent with TSCA section 5(f)(4), for the five chemical substances subject to an order under TSCA section 5(e), EPA is proposing to identify any use not conforming to the restrictions of the order as a significant new use. For the 21 chemical substances that EPA has determined “not likely” to present an unreasonable risk under the conditions of use, EPA is proposing to identify other circumstances that, while not reasonably foreseen, would warrant further EPA review before manufacture or processing for such a use is commenced.
EPA is proposing significant new use and recordkeeping requirements for 26 chemical substances in 40 CFR part 721, subpart E. In this unit, EPA provides the following information for each chemical substance:
Basis for the SNUR or basis for the TSCA 5(e) Order.
Potentially Useful Information. This is information identified by EPA that Start Printed Page 59337would help characterize the potential health and/or environmental effects of the chemical substance in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use designated by the SNUR.
These proposed rules include five PMN substances that are subject to Orders issued under TSCA section 5(e)(1)(A), as required by the determinations made under section 5(a)(3)(B). Those Orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The proposed SNURs would identify as significant new uses any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the restrictions imposed by the underlying Orders, consistent with TSCA section 5(f)(4).
These proposed rules also include 21 PMN substances that received “not likely to present an unreasonable risk” determination in TSCA section 5(a)(3)(c). However, during the course of these reviews, EPA identified concerns for certain health and/or environmental risks if the chemicals were not used following the limitations identified by the submitters in the notices, but the TSCA section 5(a)(3)(C) determinations did not deem such uses as reasonably foreseen. The proposed SNURs would identify as significant new uses any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to those same limitations.
Chemical Name: Triarylsulfonium salt (generic).
Effective date of TSCA section 5(e) Order: July 22, 2019.
Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the PMN substance will be as a resin catalyst. Based on physical/chemical properties of the PMN substance (as described in the New Chemical Program's PBT category at 64 FR 60194; November 1999), the PMN substance is a potentially persistent, bioaccumulative, and toxic (PBT) chemical. EPA estimates that that PMN substance will persist in the environment for more than 2 months and estimates a bioaccumulation factor of greater than or equal to 1,000. Based on comparison to structurally analogous chemical substances, the estimated physical/chemical properties of the PMN, and test data for the PMN substance, EPA has identified concerns for eye irritation, systemic, developmental, blood, and reproductive effects. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires:
2. Use of the PMN substance only for the confidential use specified in the Order;
3. No manufacture (including import) of the PMN substance beyond the confidential annual manufacture volume specified in the Order;
4. Refraining from processing or using the PMN substance in any manner that generates a mist, vapor, or aerosol; and
5. No release of the PMN substance into the waters of the United States.
Potentially useful information: EPA has determined that certain information about the human health effects of the PMN substance may be potentially useful in support of a request by the PMN submitter to modify the TSCA section 5(e) Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. EPA has determined that the results of specific target organ toxicity and reproductive/developmental toxicity testing would help characterize the potential health effects of the PMN substance. Although the TSCA section 5(e) Order does not require this information, the TSCA section 5(e) Order's restrictions remain in effect until the TSCA section 5(e) Order is modified or revoked by EPA based on submission of this or other relevant information.
CFR Citation: 40 CFR 721.11383.
Chemical Names: Organic acid, compds. with bisphenol A-epichlorohydrin-polypropylene glycol diglycidyl ether polymer-disubstituted amine-disubstituted polypropylene glycol reaction products (generic) (P-17-312); Phenol, 4,4′-(1-methylethylidene)bis-, polymer with 2-(chloromethyl)oxirane and alpha-(2-oxiranylmethyl)-omega-(2-oxiranylmethoxy)poly[oxy(methyl-1,2-ethanediyl)], reaction products with disubstituted amine and disubstituted polypropylene glycol, organic acid salts (generic) (P-17-313); Organic acid, 2-substituted-, compds. with bisphenol A-epichlorohydrin-polypropylene glycol diglycidyl ether polymer-disubstituted aminedisubstituted polypropylene glycol reaction products (generic) (P-17-314); Phenol, 4,4′-(1-methylethylidene)bis-, polymer with alpha-(2-substituted-methylethyl)-omega-(2-substituted-methylethoxy)poly[oxy(methyl-1,2-ethanediyl)], 2-(chloromethyl)oxirane and alpha-(2-oxiranylmethyl)-omega-(2-oxiranylmethoxy)poly[oxy(methyl-1,2-ethanediyl)], alkylphenyl ethers, reaction products with disubstituted amine, organic acid salts (generic) (P-17-315); Organic acid, compds. with bisphenol A-epichlorohydrin-disubstituted polypropylene glycol-polypropylene glycol diglycidyl ether polymer alkylphenyl ethers-disubstituted amine reaction products (generic) (P-17-316); Organic acid, compds. with bisphenol A-epichlorohydrin-polypropylene glycol diglycidyl ether polymer-disubstituted polypropylene glycol reaction products (generic) (P-17-317).
Basis for action: The PMNs state that the generic (non-confidential) use of the substances will be as additives for electrocoat. Based on the estimated physical/chemical properties of the PMN substances, comparison with structurally analogous substances, and Structural Activity Relationships (SAR) analysis on analogous polycationic polymers, EPA has identified concerns for lung effects, nasal epithelial damage, skin and eye irritation, and aquatic toxicity if the chemical substances are not used following the limitations noted. The conditions of use of the PMN substances as described in the PMNs include the following protective measures:
1. No modification of the manufacturing, processing, or use of the PMN substances that result in the Start Printed Page 59338generation of a dust, mist, or aerosol; and
2. No release of a manufacturing, processing, or use stream associated with any use of the PMN substance into the waters of the United States exceeding a surface water concentration of 78 ppb.
Potentially useful information: EPA has determined that certain information may be potentially useful to characterize the health and environmental effects of the PMN substances 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, skin irritation/corrosion, eye damage, and acute aquatic toxicity testing would help characterize the potential health effects of the PMN substances.
CFR Citations: 40 CFR 721.11384 (P-17-312), 40 CFR 721.11385 (P-17-313), 40 CFR 721.11386 (P-17-314), 40 CFR 721.11387 (P-17-315), 40 CFR 721.11388 (P-17-316), and 40 CFR 721.11389 (P-17-317).
Chemical names: Branched cyclic and linear hydrocarbons from plastic depolymerization (generic) (P-17-398), Alkane, alkene, styrenic compounds derived from plastic depolymerization (generic) (P-17-399), Carbon compound derived from plastic depolymerization (generic) (P-18-1), and Branched cyclic and linear hydrocarbons from plastic depolymerization (generic) (P-18-28).
Effective date of TSCA section 5(e) Order: June 10, 2019.
Basis for TSCA section 5(e) Order: The PMNs state that the use of P-17-398 and P-17-399 will be as a refinery feedstock or fuel blending additive, the generic use of P-18-1 will be as an additive, and the use of P-18-28 will be as a chemical feedstock. Based on the physical/chemical properties of the PMN substances and comparison to structurally analogous chemical substances, EPA has identified concerns for neurological impairment, and hematological effects including aplastic anemia and acute myelogenous leukemia for PMN substance P-18-28. There is concern for lung effects for P-18-1, if respirable, based on the respirable, poorly soluble particles category. Based on SAR analysis on analogous substances, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb for P-17-398 and P-17-399, and 15 ppb for P-18-28. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substances may present an unreasonable risk of injury to human health and the environment. The Order was also issued under TSCA sections 5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II), based on a finding that the substances are or will be produced in substantial quantities and that the substances either enter or may reasonably be anticipated to enter the environment in substantial quantities, or there is or may be significant (or substantial) human exposure to the substances. To protect against these risks, the Order requires:
1. Refraining from manufacturing, processing, or using P-17-398 and P-17-399 other than as a refinery feedstock or a fuel blending additive and refrain from manufacturing, processing, and using P-18-28 other than as a chemical feedstock or a fuel blending additive;
2. Manufacture of P-18-1 via the enclosed manufacturing process described in the PMN; and
3. Manufacture of P-18-1 according to the particle sizes described in the PMN: 1% or less of the particles at less than 75 microns.
Potentially useful information: EPA has determined that certain information about the human health and environmental effects of the PMN substances may be potentially useful in support of a request by the PMN submitter to modify the TSCA section 5(e) Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. EPA has determined that the results of additional particle size characterization testing for P-18-1 and acute and chronic aquatic toxicity testing for P-17-398, P-17-399, and P-18-28 would help EPA determine the potential human and environmental effects of the PMN substances. Although the TSCA section 5(e) Order does not require this information, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.
CFR citations: 40 CFR 721.11390 (P-17-398), 40 CFR 721.11391 (P-17-399), 40 CFR 721.11392 (P-18-1), and 40 CFR 721.11393 (P-18-28).
Chemical Name: Phosphonic acid, dimethyl ester, polymer with alkyl diols (generic).
Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be as a lubricant additive. Based on estimated physical/chemical properties of the PMN substance, test data on the PMN substance, comparison to structurally analogous chemical substances, and SAR analysis of test data on analogous esters, EPA has identified concerns for gastrointestinal and kidney effects, reproductive/developmental toxicity, and aquatic toxicity 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 release of a manufacturing, processing, or use stream associated with any use of the PMN substance into the waters of the United States exceeding a surface water concentration of 300 ppb; and
2. No manufacture, process, or use of the PMN substance that generates a dust, mist, or aerosol.
Potentially useful information: EPA has determined that certain information 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, specific target organ toxicity, and reproductive/developmental toxicity testing would help characterize the potential health and environmental effects of the PMN substance.
CFR Citation: 40 CFR 721.11394.
Chemical Name: 1H-Imidazole, 1,2,4,5-tetramethyl-.
CAS Number: 1739‐83‐9.
Basis for action: The PMN states that the use of the PMN substance will be as a chemical intermediate in the synthesis of a polymer. Based on estimated physical/chemical properties of the PMN substance, test data on analogous chemical substances, comparison to structurally analogous chemical substances, and SAR analysis of test data on analogous pyrroles/diazoles, EPA has identified concerns for irritation and corrosion to all tissues, Start Printed Page 59339developmental effects, liver toxicity, and aquatic toxicity 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:
2. No release of a manufacturing, processing, or use stream associated with any use of the PMN substance into the waters of the United States exceeding a surface water concentration of 7 ppb; and
3. No use of the PMN substance other than as a chemical intermediate.
Potentially useful information: EPA has determined that certain information may be potentially useful to characterize the health and environmental effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that the results of skin corrosion, developmental/reproductive toxicity, specific target organ toxicity, and aquatic toxicity testing would help characterize the potential health and environmental effects of the PMN substance.
CFR Citation: 40 CFR 721.11395.
Chemical Name: 1-Propanaminium, N,N′-(oxydi-2,1-ethanediyl)bis[3-chloro-2-hydroxy-N,N-dimethyl-, chloride (1:2).
CAS Number: 96320-92-2.
Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be for use in textile treatment. Based on the physical/chemical properties of the PMN substance, comparison of structurally analogous chemical substances, and SAR analysis on cationic surfactants, EPA has identified concerns for surfactant effects on the lungs, developmental effects, mutagenicity, carcinogenicity, systemic toxicity, skin and respiratory sensitization, liver and kidney toxicity and aquatic toxicity 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 manufacturing, processing, or use of the PMN substance that results in inhalation exposures; and
2. No release of a manufacturing, processing, or use stream associated with any use of the PMN substance into the waters of the United States exceeding a surface water concentration of 164 ppb.
Potentially useful information: EPA has determined that certain information 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 specific target organ toxicity, reproductive/developmental toxicity, and chronic aquatic toxicity testing would help characterize the potential health and environmental effects of the PMN substance.
CFR Citation: 40 CFR 721.11396.
Chemical Name: Fatty acid, polymer with alkanedioic acid dialkyl ester, hydroxyl alkyl substituted alkanediol, substituted carbomonocycle and alkylol substituted alkane (generic). Polymer exemption flag: The chemical must be manufactured such that it meets the polymer exemption criteria as described under 40 CFR 723.250(e)(1), in addition to meeting the definition of polymer at 40 CFR 723.250(b).
Basis for action: The PMN states that the use of the PMN substance will be as an adhesion-enhancing resin for wood applications for industrial and commercial use. Based on estimated physical/chemical properties of the PMN substance and comparison to structurally analogous chemical substances, EPA has identified concerns for developmental and reproductive effects if the chemical substance is not used following the limitation noted. The conditions of use of the PMN substance as described in the PMN include the following protective measure:
No use of the PMN substance in a consumer product.
Potentially useful information: EPA has determined that certain information 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 reproductive/developmental toxicity testing would help characterize the potential health effects of the PMN substance.
CFR Citation: 40 CFR 721.11397.
Chemical Names: 2,5-Furandione, polymer with ethenylbenzene, 4-hydroxy-substituted butyl amide, polymers with epichlorohydrin and trimethylolpropane, sodium salts (generic) (P-18-190); 2,5-Furandione, polymer with ethenylbenzene, 4-hydroxy-substitutedbutyl [3-[2-[1-[[(substitutedphenyl)amino]carbonyl]-2-oxopropyl]diazenyl]phenyl]methyl amide, polymers with epichlorohydrin and trimethylolpropane, sodium salts (generic) (P-18-191).
Basis for action: The PMNs state that the use of the substances will be as a pigment dispersing aid for pigments in inkjet printing inks. Based on the estimated physical/chemical properties, high pH, chelating potential of the polyanionic groups and comparison with structurally analogous chemical substances, EPA has identified concerns for developmental and blood effects, and eye, skin, and lung irritation if the chemical substances are not used following the limitation noted. The conditions of use of the PMN substances as described in the PMNs include the following protective measure:
Use of the PMN substances only as pigment dispersing aids for pigments in inkjet printing inks.
Potentially useful information: EPA has determined that certain information may be potentially useful to characterize the health effects of the PMN substances 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 reproduction/developmental toxicity, skin irritation, and eye damage testing would help characterize the potential health effects of the PMN substances.
CFR Citations: 40 CFR 721.11398 (P-18-190) and 40 CFR 721.11399 (P-18-191).
Chemical Name: Alkane, bis(alkoxymethyl)-dimethyl- (generic).
Basis for action: The PMN states that the use of the PMN substance will be as a selectivity improver for catalysts used in polyolefin production. Based on estimated physical/chemical properties, comparison to structurally analogous chemical substances, test data on the PMN substance, and SAR analysis on analogous neutral organics, EPA has Start Printed Page 59340identified concerns for eye irritation, systemic and developmental toxicity, neurotoxicity and aquatic toxicity if the chemical substance is not used following the limitation noted. The conditions of use of the PMN substance as described in the PMN include the following protective measure:
No manufacture of the PMN substance beyond the confidential annual production volume specified in the PMN.
Potentially useful information: EPA has determined that certain information 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 toxicokinetics, specific organ toxicity, irritation, neurotoxicity, systemic toxicity, reproductive/developmental toxicity, and aquatic toxicity testing would help characterize the potential health and environmental effects of the PMN substance.
CFR Citation: 40 CFR 721.11400.
Chemical Name: Butanedioic acid, 2-methylene-, polymer with 2-methyl-2-[(1-oxo-2-propen-1-yl)amino]-1-propanesulfonic acid, sodium zinc salt.
CAS Number: 2220235-78-7.
Basis for action: The PMN states that the use of the PMN substance will be for odor neutralization for pet litter and cleaning/deodorizing hard surfaces, fabrics, skin and hair, odor neutralization for air care, and odor neutralization for waste processing and solid waste management in paper, oil, gas, mining, agriculture, and food and municipal industries. Based on SAR analysis on analogous polyanionic polymers, EPA has identified concerns for aquatic toxicity if the chemical substance is not used following the limitation noted. The conditions of use of the PMN substance as described in the PMN include the following protective measure:
No release of a manufacturing, processing, or use stream associated with any use of the PMN substance into the waters of the United States exceeding a surface water concentration of 143 ppb.
Potentially useful information: EPA has determined that certain information may be potentially useful to characterize the 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 chronic aquatic toxicity testing would help characterize the potential environmental effects of the PMN substance.
CFR Citation: 40 CFR 721.11404.
Chemical Name: Heteromonocycle, alkenoic 1:1 salt, polymer with alpha-(2-methyl-1-oxo-2-propen-1-y)l-omega-methoxypoly(oxy-1,2-ethanediyl) and methyl-alkenoic acid (generic).
Basis for action: The PMN states that the use of the PMN substance will be as an additive for automatic dishwashing detergent. Based on the estimated physical/chemical properties of the PMN substance, comparison with structurally analogous chemical substances, and available data on the new chemical substance, EPA has identified concerns for lung effects 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 manufacturing, processing, or use that results in particles less than 50 microns; and
2. No use that results in consumer inhalation or dermal exposure and use only in sealed, single-use packets.
Potentially useful information: EPA has determined that certain information may be potentially useful to characterize the health effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that the results of pulmonary effects, specific target organ effects, and developmental/reproductive toxicity testing would help characterize the potential health effects of the PMN substance.
CFR Citation: 40 CFR 721.11405.
Chemical Name: Substituted benzylic ether polyethylene glycol alkyl ether derivative (generic).
Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be as a chemical intermediate. Based on estimated physical/chemical properties of the PMN substance, comparison to structurally analogous chemical substances, and test data on the PMN substance, and SAR analysis on analogous nonionic surfactants, EPA has identified concerns for ocular, lung and mucous membrane irritation, lung effects, skin and respiratory sensitization, systemic effects, neurotoxicity, immunotoxicity, and aquatic toxicity if the chemical substance is not used following the limitation noted. The condition of use of the PMN substance as described in the PMN includes the following protective measures:
1. No use of the PMN substance involving application methods that generate a vapor, mist, or aerosol; and
2. No release of a manufacturing, processing, or use stream associated with any use of the PMN substance into the waters of the United States exceeding a surface water concentration of 4 ppb.
Potentially useful information: EPA has determined that certain information 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 specific target organ toxicity, neurotoxicity, sensitization, eye damage, skin irritation, and algal toxicity testing would help characterize the potential health and environmental effects of the PMN substance.
CFR Citation: 40 CFR 721.11406.
Chemical Name: Alkylmultiheteroatom, 2-functionalisedalkyl-2-hydroxyalkyl-, polymer with alkylheteroatom-multialkylfunctionalised carbomonocycleheteroatom and multiglycidylether difunctionalised polyalkylene glycol (generic).
Basis for action: The PMN states that the use of the PMN substance will be as an epoxy curing agent used in molding formulations for the manufacture of wind turbine blades. Based on estimated physical/chemical properties of the PMN substance and comparison of structurally analogous chemical substances, EPA has identified concerns for pulmonary effects, skin corrosion, eye irritation, skin sensitization, and kidney toxicity if the chemical substance is not used following the limitations noted. The conditions of use Start Printed Page 59341of the PMN substance as described in the PMN include the following protective measures:
1. No manufacturing (including import), processing, or use of the PMN substance that results in inhalation exposures; and
2. No release of a manufacturing, processing, or use stream associated with any use of the PMN substance into the waters of the United States.
Potentially useful information: EPA has determined that certain information about the health effects of the PMN substance may be potentially useful 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 pulmonary toxicity, specific target organ toxicity, and skin sensitization testing using the reconstructed human cornea-like epithelium test method would help characterize the potential health effects of the PMN substance.
CFR Citation: 40 CFR 721.11407.
Chemical Name: Benzenedicarboxylic acid, reaction products with isobenzofurandione and diethylene glycol (generic).
Basis for action: The PMN states that the use of the PMN substance will be as a resin component for polyisocyanurate resins and specialty polyurethane kits and systems for aerospace and military applications. Based on comparison to structurally analogous chemical substances, EPA has identified concerns for bladder, kidney, and reproductive/developmental toxicity if the chemical substance is not used following the limitation noted. The conditions of use of the PMN substance as described in the PMN include the following protective measure:
Potentially useful information: EPA has determined that certain information about the health effects of the PMN substance may be potentially useful 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/reproductive toxicity, specific target organ toxicity, and eye and skin irritation testing would help characterize the potential health effects of the PMN substance.
CFR Citation: 40 CFR 721.11408.
Chemical Name: Formaldehyde, polymer with N1-(2-aminoethyl)-alkanediamine, 5-amino-1,3,3-trimethylcyclohexanemethanamine, 2-(chloromethyl)oxirane, 4,4′-(1-methylethylidene)bis[Phenol] and alpha-hydro-omega-hydroxypoly(oxy-1,2-ethanediyl) (generic).
Basis for action: The PMN states that the use of the PMN substance will be as a curing agent for epoxy coating systems. Based on the estimated physical/chemical properties of the PMN substance, comparison with structurally analogous chemical substances, and SAR analysis on analogous polycationic polymers, EPA has identified concerns for irritation, lung effects, carcinogenicity, systemic toxicity, neurotoxicity, and aquatic toxicity 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 release of a manufacturing, processing, or use stream associated with any use of the PMN substance into the waters of the United States exceeding a surface water concentration of 1 ppb; and
2. No manufacturing, processing, or use of the substance that results in inhalation exposures.
Potentially useful information: EPA has determined that certain information 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 specific target organ toxicity, skin irritation, neurotoxicity, carcinogenicity and aquatic toxicity testing would help characterize the potential health and environmental effects of the PMN substance.
CFR Citation: 40 CFR 721.11409.
Chemical Name: 2,4-Hexadienoic acid, 1,1′-[2-ethyl-2-[(1-oxo-2,4-hexadien-1-yl)oxy]methyl]-1,3-propanediyl] ester.
CAS Number: 2307636-51-5.
Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be as a physical property modifier for polymers. Based on estimated physical/chemical properties, the comparison of structurally analogous chemical substances and SAR analysis on esters, EPA has identified concerns for liver, developmental, and aquatic toxicity if the chemical substance is not used following the limitation noted. The conditions of use of the PMN substance as described in the PMN include the following protective measures:
1. Use of the PMN substance only for the confidential use specified in the PMN; and
2. No manufacture of the PMN substance beyond the confidential annual production volume specified in the PMN.
Potentially useful information: EPA has determined that certain information 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 reproductive toxicity, specific target organ toxicity, and aquatic toxicity testing would help characterize the potential health and environmental effects of the PMN substance.
CFR Citation: 40 CFR 721.11410.
Chemical Name: 1-Butanol, reaction products with 2-[(2-propen-1-yloxy)methyl]oxirane.
Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be as a raw material used in chemical manufacture. Based on available data on the PMN substance, EPA has identified concerns for acute toxicity, corrosion to all exposed tissues, sensitization, and hematological and skin changes if the chemical substance is not used following the limitation noted. The condition of use of the PMN substance as described in the PMN includes the following protective measure:
Use of the PMN substance only for the confidential use specified in the PMN;
Potentially useful information: EPA has determined that certain information may be potentially useful to characterize Start Printed Page 59342the health effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that the results of acute toxicity, sensitization, and systemic effects would help characterize the potential health effects of the PMN substance.
CFR Citation: 40 CFR 721.11411.
During review of the PMNs submitted for the chemical substances that are subject to these proposed SNURs, EPA concluded that for five chemical substances regulation was warranted under TSCA section 5(e), pending the development of information sufficient to make reasoned evaluations of the health or environmental effects of the chemical substances. The basis for such findings is outlined in Unit IV. Based on these findings, TSCA section 5(e) Orders requiring the use of appropriate exposure controls were negotiated with the PMN submitters. As a general matter, EPA believes it is necessary to follow TSCA section 5(e) Orders with a SNUR that identifies the absence of those protective measures as Significant New Uses to ensure that all manufacturers and processors—not just the original submitter—are held to the same standard.
During review of the other 21 chemical substances that are the subject of these SNURs and as further discussed in Unit IV, EPA identified certain circumstances that raised potential risk concerns. EPA determined that deviations from the limitations identified in the submissions 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, and therefore warranted SNURs. The SNURs would identify as significant new uses any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the certain limitations in the submission.
EPA is proposing these SNURs for specific chemical substances which have undergone premanufacture review because the Agency wants:
When chemical substances identified in this proposed rule are added to the TSCA Inventory, EPA recognizes that, before the rule is effective, other persons might engage in a use that has been identified as a significant new use. However, TSCA section 5(e) Orders have been issued for five of the 26 chemical substances, and the PMN submitters are prohibited by the TSCA section 5(e) Orders from undertaking activities which would be designated as significant new uses. The identities of 21 of the 26 chemical substances subject to this proposed rule have been claimed as confidential (per 40 CFR 720.85) for a chemical substance covered by this action. Based on this, the Agency believes that it is highly unlikely that any of the significant new uses described in the regulatory text of this proposed rule are ongoing.
Therefore, EPA designates November 4, 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.
In the absence of a TSCA section 4 test rule 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 identified by EPA that would help characterize the potential health and/or environmental effects of the PMN/SNUN substance for all of the listed SNURs. EPA recognizes that the 2016 Lautenberg Amendments have led to modifications in our approach to testing requirements, including an increased consideration of alternatives to vertebrate testing. Descriptions of tests/information needs are provided for informational purposes only and EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol selection. 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 potentially useful information. EPA encourages dialogue with Agency representatives to help determine how best the submitter Start Printed Page 59343can meet both the data needs and the objective of TSCA section 4(h). To access the OCSPP test guidelines referenced in this document electronically, please go to http://www.epa.gov/​ocspp and select “Test Methods and Guidelines.” The Organisation for Economic Co-operation and Development test guidelines are available from the OECD Bookshop at http://www.oecdbookshop.org or SourceOECD at http://www.sourceoecd.org.
EPA has evaluated the potential costs of establishing SNUN requirements for potential manufacturers and processors of the chemical substances subject to this proposed rule. EPA's complete economic analysis is available in the docket under docket ID number EPA-HQ-OPPT-2019-0494.
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 the PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR part 9, and included on the related collection instrument or form, if applicable.
The information collection activities in this proposed rule have already been approved by OMB pursuant to the 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.
Pursuant to RFA section 605(b) (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, 10 in FY2016, 14 in FY2017, and 18 in FY2018 and 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.
Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or Tribal government will be impacted by this action. As such, EPA has determined that this proposed rule would not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).Start Printed Page 59344
This proposed rule 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).
This proposed rule would not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This proposed rule would not significantly nor uniquely affect the communities of Indian Tribal governments, nor would it involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175 (65 FR 67249, November 9, 2000), do not apply to this action.
This proposed rule is not subject to Executive Order 13211 (66 FR 28355, May 22, 2001), because this proposed rule is not expected to affect energy supply, distribution, or use and because this proposed rule is not a significant regulatory action under Executive Order 12866.
In addition, since this proposed rule would not involve any technical standards, NTTAA section 12(d) (15 U.S.C. 272 note) does not apply to this action.
2. Add §§ 721.11383 through 721.11411 to subpart E to read as follows:
§ 721.11383
Triarylsulfonium salt (generic).
§ 721.11384
Organic acid, compds. with bisphenol A-epichlorohydrin-polypropylene glycol diglycidyl ether polymer-disubstituted amine-disubstituted polypropylene glycol reaction products (generic).
§ 721.11385
Phenol, 4,4′-(1-methylethylidene)bis-, polymer with 2-(chloromethyl)oxirane and alpha-(2-oxiranylmethyl)-omega-(2-oxiranylmethoxy)poly[oxy(methyl-1,2-ethanediyl)], reaction products with disubstituted amine and disubstituted polypropylene glycol, organic acid salts (generic).
§ 721.11386
Organic acid, 2-substituted-, compds. with bisphenol A-epichlorohydrin-polypropylene glycol diglycidyl ether polymer-disubstituted aminedisubstituted polypropylene glycol reaction products (generic).
§ 721.11387
Phenol, 4,4′-(1-methylethylidene)bis-, polymer with alpha-(2-substituted-methylethyl)-omega-(2-substituted-methylethoxy)poly[oxy(methyl-1,2-ethanediyl)], 2-(chloromethyl)oxirane and alpha-(2-oxiranylmethyl)-omega-(2-oxiranylmethoxy)poly[oxy(methyl-1,2-ethanediyl)], alkylphenyl ethers, reaction products with disubstituted amine, organic acid salts (generic).
§ 721.11388
Organic acid, compds. with bisphenol A-epichlorohydrin-disubstituted polypropylene glycol-polypropylene glycol diglycidyl ether polymer alkylphenyl ethers-disubstituted amine reaction products (generic).
§ 721.11389
Organic acid, compds. with bisphenol A-epichlorohydrin-polypropylene glycol diglycidyl ether polymer-disubstituted polypropylene glycol reaction products (generic).
§ 721.11390
Branched cyclic and linear hydrocarbons from plastic depolymerization (generic).
§ 721.11391
Alkane, alkene, styrenic compounds derived from plastic depolymerization (generic).
§ 721.11392
Carbon compound derived from plastic depolymerization (generic).
§ 721.11393
§ 721.11394
Phosphonic acid, dimethyl ester, polymer with alkyl diols (generic).
§ 721.11395
1H-Imidazole, 1,2,4,5-tetramethyl-.
§ 721.11396
1-Propanaminium, N,N′-(oxydi-2,1-ethanediyl)bis[3-chloro-2-hydroxy-N,N-dimethyl-, chloride (1:2).
§ 721.11397
Fatty acid, polymer with alkanedioic acid dialkyl ester, hydroxyl alkyl substituted alkanediol, substituted carbomonocycle and alkylol substituted alkane (generic).
§ 721.11398
2,5-Furandione, polymer with ethenylbenzene, 4-hydroxy-substituted butyl amide, polymers with epichlorohydrin and trimethylolpropane, sodium salts (generic).
§ 721.11399
2,5-Furandione, polymer with ethenylbenzene, 4-hydroxy-substitutedbutyl [3-[2-[1-[[(substitutedphenyl)amino]carbonyl]-2-oxopropyl]diazenyl]phenyl]methyl amide, polymers with epichlorohydrin and trimethylolpropane, sodium salts (generic).
§ 721.11400
Alkane, bis(alkoxymethyl)-dimethyl- (generic).
§ 721.11401
§ 721.11402
§ 721.11403
§ 721.11404
Butanedioic acid, 2-methylene-, polymer with 2-methyl-2-[(1-oxo-2-propen-1-yl)amino]-1-propanesulfonic acid, sodium zinc salt.
§ 721.11405
Heteromonocycle, alkenoic (1:1) salt, polymer with alpha-(2-methyl-1-oxo-2-propen-1-y)l-omega.-methoxypoly(oxy-1,2-ethanediyl) and methyl-alkenoic acid (generic).
§ 721.11406
Substituted benzylic ether polyethylene glycol alkyl ether derivative (generic).
§ 721.11407
Alkylmultiheteroatom, 2-functionalisedalkyl-2-hydroxyalkyl-, polymer with alkylheteroatom-multialkylfunctionalised carbomonocycleheteroatom and multiglycidylether difunctionalised polyalkylene glycol (generic).
§ 721.11408
Benzenedicarboxylic acid, reaction products with isobenzofurandione and diethylene glycol (generic).
§ 721.11409
Formaldehyde, polymer with N1-(2-aminoethyl)-alkanediamine, 5-amino-1,3,3-trimethylcyclohexanemethanamine, 2-(chloromethyl)oxirane, 4,4′-(1-methylethylidene)bis[Phenol] and alpha-hydro-omega-hydroxypoly(oxy-1,2-ethanediyl) (generic).
§ 721.11410
2,4-Hexadienoic acid, 1,1′-[2-ethyl-2-[(1-oxo-2,4-hexadien-1-yl)oxy]methyl]-1,3-propanediyl] ester.Start Printed Page 59345
§ 721.11411
1-Butanol, reaction products with 2-[(2-propen-1-yloxy)methyl]oxirane.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as triarylsulfonium salt (PMN P-16-548) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f), (k), and (t). It is a significant new use to process or use the substance in a manner that generates a vapor, mist, or aerosol.
(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (c) and (i) and (k) are applicable to manufacturers and processors of this substance.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as organic acid, compds. with bisphenol A-epichlorohydrin-polypropylene glycol diglycidyl ether polymer-disubstituted amine-disubstituted polypropylene glycol reaction products (PMN P-17-312) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(i) Industrial, commercial, and consumer activities. It is a significant new use to modify the manufacture, process, or use of the substance that results in the generation of a dust, mist, or aerosol.
(ii) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) where N = 78.
(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (c), (i) and (k) are applicable to manufacturers and processors of this substance.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as phenol, 4,4′-(1-methylethylidene)bis-, polymer with 2-(chloromethyl)oxirane and alpha-(2-oxiranylmethyl)-omega-(2-oxiranylmethoxy)poly[oxy(methyl-1,2-ethanediyl)], reaction products with disubstituted amine and disubstituted polypropylene glycol, organic acid salts (PMN P-17-313) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as organic acid, 2-substituted-, compds. with bisphenol A-epichlorohydrin-polypropylene glycol diglycidyl ether polymer-disubstituted aminedisubstituted polypropylene glycol reaction products (PMN P-17-314) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as phenol, 4,4′-(1-methylethylidene)bis-, polymer with alpha-(2-substituted-methylethyl)-omega-(2-substituted-methylethoxy)poly[oxy(methyl-1,2-ethanediyl)], 2-(chloromethyl)oxirane and alpha-(2-oxiranylmethyl)-omega-(2-oxiranylmethoxy)poly[oxy(methyl-1,2-ethanediyl)], alkylphenyl ethers, reaction products with disubstituted amine, organic acid salts (PMN P-17-315) is subject to reporting under this section for the significant new uses Start Printed Page 59346described in paragraph (a)(2) of this section.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as organic acid, compds. with bisphenol A-epichlorohydrin-disubstituted polypropylene glycol-polypropylene glycol diglycidyl ether polymer alkylphenyl ethers-disubstituted amine reaction products (PMN P-17-316) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as organic acid, compds. with bisphenol A-epichlorohydrin-polypropylene glycol diglycidyl ether polymer-disubstituted polypropylene glycol reaction products (PMN P-17-317) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as branched cyclic and linear hydrocarbons from plastic depolymerization (PMN P-17-398) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance that have been refined or blended into other chemical or fuel formulations.
(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80 (k)(other than as a refinery feedstock or a fuel blending additive).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkane, alkene, styrenic compounds derived from plastic depolymerization (PMN P-17-399) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance that have been refined or blended into other chemical or fuel formulations.
(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k) (other than as a refinery feedstock or a fuel blending additive).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as carbon compound derived from plastic depolymerization (PMN P-18-1) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(i) Industrial, commercial, and consumer activities. It is a significant new use to manufacture the substance containing more than 1% of the particles less than 75 microns. It is a significant new use to manufacture the substance other than by the enclosed process described in the premanufacture notice.
(b) Specific requirements. The provisions of subpart A of this part Start Printed Page 59347apply to this section except as modified by this paragraph.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as branched cyclic and linear hydrocarbons from plastic depolymerization (PMN P-18-28) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance that have been refined or blended into other chemical or fuel formulations.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as phosphonic acid, dimethyl ester, polymer with alkyl diols (PMN P-18-9) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(i) Industrial, commercial, and consumer activities. It is a significant new use to manufacture, process, or use the PMN substance in a manner that generates a dust, mist, or aerosol.
(ii) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) where N = 300.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1H-Imidazole, 1,2,4,5-tetramethyl- (PMN P-18-11, CAS No. 1739-83-9) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80 (f) and (g).
(ii) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) where N = 7.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1-propanaminium, N,N′-(oxydi-2,1-ethanediyl)bis[3-chloro-2-hydroxy-N,N-dimethyl-, chloride (1:2) (PMN P-18-170, CAS No. 96320-92-2) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(ii) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) where N = 164.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as fatty acid, polymer with alkanedioic acid dialkyl ester, hydroxyl alkyl substituted alkanediol, substituted carbomonocycle and alkylol substituted alkane (PMN P-18-185) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80 (o).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as 2,5-furandione, polymer with ethenylbenzene, 4-hydroxy-substituted butyl amide, polymers with epichlorohydrin and trimethylolpropane, sodium salts (PMN P-18-190) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(i) Industrial, commercial, and consumer activities. It is a significant new use to use the substance other than as a pigment dispersing aid for pigments in inkjet printing inks.Start Printed Page 59348
(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (c), and (i) are applicable to manufacturers and processors of these substances.
2,5-Furandione, polymer with ethenylbenzene, 4-hydroxy-substitutedbutyl [3-[2-[1-[[(substitutedphenyl)amino]carbonyl]-2-oxopropyl]diazenyl]phenyl]methyl amide, polymers with epichlorohydrin and trimthylolpropane, sodium salts (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as 2,5-furandione, polymer with ethenylbenzene, 4-hydroxy-substitutedbutyl [3-[2-[1-[[(substitutedphenyl)amino]carbonyl]-2-oxopropyl]diazenyl]phenyl]methyl amide, polymers with epichlorohydrin and trimthylolpropane, sodium salts (PMN P-18-191) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(i) Industrial, commercial, and consumer activities. It is a significant new use to use the substance other than as a pigment dispersing aid for pigments in inkjet printing inks.
Alkane, bis(alkoxymethyl)-dimethyl-0 ((generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as alkane, bis(alkoxymethyl)-dimethyl- (PMN P-18-223) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(i) Industrial, commercial, and consumer activities. It is a significant new use to manufacture the substance greater than the confidential annual production volume specified in the PMN.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as butanedioic acid, 2-methylene-, polymer with 2-methyl-2-[(1-oxo-2-propen-1-yl)amino]-1-propanesulfonic acid, sodium zinc salt (PMN P-18-285, CAS No. 2220235-78-7) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(i) Releases to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) where N = 143.
Heteromonocycle, alkenoic 1:1 salt, polymer with alpha-(2-methyl-1-oxo-2-propen-1-y)l-omega.-methoxypoly(oxy-1,2-ethanediyl) and methyl-alkenoic acid (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as heteromonocycle, alkenoic 1:1 salt, polymer with alpha-(2-methyl-1-oxo-2-propen-1-y)l-omega.-methoxypoly(oxy-1,2-ethanediyl) and methyl-alkenoic acid (PMN P-18-300) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(i) Industrial, commercial, and consumer activities. It is a significant new use to manufacture, process, or use the PMN substance in a manner that results in particles less than 50 microns. It is a significant new use to use the PMN substance in a manner that results in consumer inhalation or dermal exposure, and use other than as sealed, single-use packets.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as substituted benzylic ether polyethylene glycol alkyl ether derivative (PMN P-18-394) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(ii) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) where N = 4.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkylmultiheteroatom, 2-functionalisedalkyl-2-hydroxyalkyl-, polymer with alkylheteroatom-multialkylfunctionalised carbomonocycleheteroatom and multiglycidylether difunctionalised polyalkylene glycol (PMN P-18-404) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as benzenedicarboxylic acid, reaction products with isobenzofurandione and diethylene glycol (PMN P-19-12) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as formaldehyde, polymer with N1-(2-aminoethyl)-alkanediamine, 5-amino-1,3,3-trimethylcyclohexanemethanamine, 2-(chloromethyl)oxirane, 4,4′-(1-methylethylidene)bis[Phenol] and alpha-hydro-omega-hydroxypoly(oxy-1,2-ethanediyl) (PMN P-19-31) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
2,4-Hexadienoic acid, 1,1′-[2-ethyl-2-[(1-oxo-2,4-hexadien-1-yl)oxy]methyl]-1,3-propanediyl] ester.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 2,4-hexadienoic acid, 1,1′-[2-ethyl-2-[(1-oxo-2,4-hexadien-1-yl)oxy]methyl]-1,3-propanediyl] ester (PMN P-19-71, CAS No. 2307636-51-5) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1-butanol, reaction products with 2-[(2-propen-1-yloxy)methyl]oxirane (PMN P-19-72) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(i).
[FR Doc. 2019-23388 Filed 11-1-19; 8:45 am]