Source: https://www.federalregister.gov/documents/2019/10/11/2019-21720/significant-new-use-rules-on-certain-chemical-substances-19-3f
Timestamp: 2019-10-16 04:37:27
Document Index: 285293333

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Federal Register :: Significant New Use Rules on Certain Chemical Substances (19-3.F)
A Proposed Rule by the Environmental Protection Agency on 10/11/2019
84 FR 54816
54816-54832 (17 pages)
EPA-HQ-OPPT-2019-0228
FRL-9998-64
Economic Analysis for 31 chemicals in SNUR batch "19-3.F"
P-19-0054 SAT Report Sanitized
P-19-0054 HLTH Report Sanitized
P-19-0054 HLTH Report Post Focus Final Sanitized
P-19-0054 FATE Report Sanitized
P-19-0054 EXP Report Sanitized
P-19-0054 ENG Report Sanitized
P-19-0054 ECO Report Sanitized
P-19-0054 CHEM Report Sanitized
P-19-0035 HLTH Report Post-Focus Final Sanitized
See all 204 supporting documents
PMN Numbers: P-16-151, P-16-152, P-16-153, P-16-154, and P-16-155
PMN Number: P-16-225
PMN Number: P-16-314
PMN Number: P-16-429
PMN Number: P-16-470
PMN Number: P-17-108
PMN Number: P-17-253
PMN Number: P-18-91
PMN Number: P-18-120
PMN Number: P-18-129
PMN Number: P-18-182
PMN Number: P-18-186
PMN Numbers: P-18-247, P-18-248, P-18-249, P-18-250, P-18-251, and P-18-252
PMN Number: P-18-282
PMN Number: P-18-305
PMN Number: P-18-339
PMN Number: P-19-5
PMN Number: P-19-20
PMN Number: P-19-35
PMN Number: P-19-54
VI. Applicability of the Proposed Significant New Use Designation
PARTS 721—[AMENDED]
https://www.federalregister.gov/d/2019-21720 https://www.federalregister.gov/d/2019-21720
EPA is proposing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for 31 chemical substances which were the subject of premanufacture notices (PMNs). Eight of these chemical substances are subject to TSCA Orders issued by EPA and the remaining 23 of these chemical substances received a “not likely to present an unreasonable risk” determination. This action would require persons who intend to manufacture (defined by statute to include import) or process any of these 31 chemical substances for an activity that is proposed as a significant new use to notify EPA at least 90 days before commencing that activity. 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-2019-0228, by one of the following methods:
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 Start Printed Page 5481712.118 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 November 12, 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) (FRL-3658-5). 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.
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.
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 section 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 31 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 eight 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 23 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 31 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 section 5(e) Order.
Potentially Useful Information. This is information identified by EPA that would 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.Start Printed Page 54818
CFR citation assigned in the regulatory text section of the proposed rule. The regulatory text section of each proposed rule specifies the activities that would be designated as significant new uses. Certain new uses, including exceedance of production volume limits (i.e., limits on manufacture volume) and other uses designated in this proposed rule, may be claimed as CBI.
These proposed rules include 8 PMN substances that are subject to orders issued under TSCA section 5(e)(1)(A), as required by the determinations made under TSCA section 5(a)(3)(B). Those TSCA section 5(e) 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 TSCA section 5(e) Orders, consistent with TSCA section 5(f)(4).
These proposed rules also include 23 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. EPA did not deem such uses as reasonably foreseen in the TSCA section 5(a)(3)(C) determinations. 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.
The chemicals subject to these proposed SNURs are as follows:
Chemical names: Perfluoropolyether halide (generic) (P-16-151), Perfluoropolyether aryl (generic) (P-16-152), Substituted aryl-perfluoropolyether (generic) (P-16-153), Sulfonated perfluoropolyether aromatic transition metal salt (generic) (P-16-154), and Sulfonated perfluoropolyether aryl alkali metal salt (generic) (P-16-155).
Effective date of TSCA section 5(e) Order: April 30, 2019.
Basis for TSCA section 5(e) Order: The PMNs state that the generic (non-confidential) use of the substances P-16-151 and P-16-152 will be as intermediates and P-16-153, P-16-154, P-16-155 will be as lubricant additives. Based on the physical/chemical properties of the PMN substances (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 substances are potentially persistent, bioaccumulative, and toxic (PBT) chemicals. EPA estimates that the PMN substances will persist in the environment more than 2 months and estimates a bioaccumulation factor of greater than or equal to 1,000. Based on results of testing on analogous small fluorinated polyether substances, EPA has identified concerns for the possible degradation products of the PMN substances for liver toxicity, kidney effects, hematology and clinical chemistry changes, pancreatic and testicular cell tumor formation, and reproductive and developmental effects. Based on estimated ecotoxicity values for the possible degradation products, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 153 parts per billion (ppb). The TSCA section 5(e) Order was issued under TSCA sections 5(a)(3)(B)(i) and 5(e)(1)(A)(i), based on a finding that the available information is insufficient to permit a reasoned evaluation of the human health and environmental effects of the PMN substances. The TSCA section 5(e) Order was also 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. To protect against these risks, the TSCA section 5(e) Order requires:
1. Submission to EPA of certain fate testing within one year after the Notice of Commencement of the PMN P-16-155;
2. Establishment and use of a hazard communication program, including environmental hazard precautionary statements on each label and in the Safety Data Sheet (SDS);
3. Dispose of the PMN substances only with Hazardous Waste, High Temperature Incineration with a control efficiency of 99.99% efficiency or greater;
4. No release of the PMN substances to surface waters;
5. Manufacture the PMN substances only for the confidential uses specified in the PMNs; and
6. No manufacture beyond the annual production volumes specified in the TSCA section 5(e) Order.
Potentially useful information: EPA has determined that certain information 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. The submitter has agreed not to manufacture (including import) the P-16-155 substance beyond one year after the Notice of Commencement without performing an indirect photolysis screening test (OCSPP Test Guideline 835.5270). EPA has also determined that the results of hydrolysis testing, photodegradation in soil, chronic aquatic toxicity, and reproductive toxicity testing would help EPA determine the potential human and environmental effects of the PMN substances. Although the TSCA section 5(e) Order does not require these tests, 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 citations: 40 CFR 721.11346 (P-16-151); 40 CFR 721.11347 (P-16-152); 40 CFR 721.11348 (P-16-153); 40 CFR 721.11349 (P-16-154) and 40 CFR 721.11350 (P-16-155).
Chemical names: Cyclohexanol, 4-ethylidene-2-propoxy- (P-16-225, chemical A) and Cyclohexanol, 5-ethylidene-2-propoxy- (P-16-225, chemical B).
CAS numbers: 1631145-48-6 (P-16-225, chemical A) and 1631145-49-7 (P-16-225, chemical B).
Basis for action: The PMN states that the use of the substance will be as a fragrance ingredient, being blended (mixed) with other fragrance ingredients to make fragrance oils that will be sold to industrial and commercial customers for their incorporation into soaps, detergents, cleaners, air fresheners, candles and other similar industrial, household and consumer products. Based on the physical/chemical properties of the PMN substances, test data on the PMN substances, and Structure Analysis Relationships (SAR) analysis of test data on analogous substances, EPA has identified concerns for systemic toxicity, and aquatic toxicity at surface water concentrations exceeding 300 ppb, if the chemical substance is not used following the limitations noted. The conditions of use of the PMN substances as described in the PMN include the following protective measures:Start Printed Page 54819
1. No domestic manufacture of the PMN substances (i.e., import only);
2. No import of the PMN substances at more than 10,000 kg annual production volume;
3. No use of the PMN substances other than for the fragrance use stated in the PMN submission; and
4. No processing of the PMN substances to greater than 10% in compounded fragrance oil formulation.
Potentially useful information: EPA has determined that certain information may be potentially useful to characterize the health and environmental effects of the PMN substances 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 proposed SNUR. EPA has determined that the results of absorption testing and aquatic toxicity testing would help characterize the potential health and environmental effects of the PMN substances.
CFR citation: 40 CFR 721.11351 (P-16-225, chemical A) and 40 CFR 721.11352 (P-16-225, chemical B).
Chemical Name: Ethanone, 1-(5-propyl-1,3-benzodioxol-2-yl)-.
CAS Number: 1370699-98-1.
Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be as part of a fragrance formula. Based on test data on the new chemical substance, the estimated physical/chemical properties of the PMN, and SAR analysis on analogous neutral organics, EPA has identified concerns for liver toxicity for the intact new chemical substance, oncogenicity for the ketone/aldehyde hydrolysis product(s) that may be formed under the acidic conditions in the stomach, 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 domestic manufacture of the PMN substance (i.e., import only);
2. Less than 10% of the PMN substance in any formulation from processing; and
3. No manufacture (including import) beyond an annual production volume of 10,000 kilograms per year.
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 absorption testing and aquatic toxicity testing would help characterize the potential health and environmental effects of the PMN substance.
CFR Citation: 40 CFR 721.11353.
Chemical Name: Endcapped polysiloxane (generic).
Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be as a universal tint paste resin having high solids. Based on the estimated physical/chemical properties of the PMN substance, structural information, and information on analogous alkoxysilanes, EPA has identified lung effects and irritation to the eye, skin, lung, and mucous membranes 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 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 and skin irritation testing would help characterize the potential health effects of the PMN substance.
CFR Citation: 40 CFR 721.11354.
Chemical Name: 2,7-Nonadien-4-ol, 4,8-dimethyl-.
CAS Number: 103983-77-3.
Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be as part of a fragrance formula. Based on the estimated physical/chemical properties of the PMN substance and available data on the new chemical substance, EPA has identified concerns for skin irritation, eye irritation, liver and thyroid 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 measure:
No release of the PMN substance from manufacturing or processing resulting in surface water concentrations that exceed 113 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 organ toxicity and aquatic toxicity testing would help characterize the potential health and environmental effects of the PMN substance.
CFR Citation: 40 CFR 721.11355.
Chemical Name: Carbonodithioic acid, O-[2-[(dithiocarboxy)amino]-2-methylpropyl] ester, sodium salt (1:2).
CAS Number: 1947332-67-3.
Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be for use in ore processing. Based on the estimated physical/chemical properties of the PMN substance, available PMN data, comparison with structurally analogous chemical substances, and SAR analysis of test data on analogous dithiocarbamates, EPA has identified concerns for irritation and corrosion to all tissues, developmental and neurological effects, 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 measure:
No release of the PMN substance resulting in surface water concentrations exceeding 2 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 reproductive/developmental toxicity, neurotoxicity, skin irritation/Start Printed Page 54820corrosion, and toxicokinetics and chronic aquatic ecotoxicity testing would help characterize the potential health and environmental effects of the PMN substance.
CFR Citation: 40 CFR 721.11356.
Chemical Name: Oxirane, 2-methyl-, polymer with oxirane, methyl 2-(substituted carbomonocycle isoquinolin-2(3H)-yl) propyl ether (generic).
Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be to enhance formulation solubilization properties. Based on its estimated physical/chemical properties, data on analogous chemicals, and other structural information, EPA has identified concerns for lung effects and irritation if the chemical substance is not used following the limitations noted. The condition of use of the PMN substance as described in the PMN includes the following protective measures:
No processing of the substance to a concentration greater than 5% by weight in the final formulated product, for any use; and
No consumer use.
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 pulmonary effects testing would help characterize the potential health effects of the PMN substance.
CFR Citation: 40 CFR 721.11357.
Chemical Name: Vegetable oil, polymers with diethylene glycol- and polyol- and polyethylene glycol-depolymd. poly(ethylene terephthalate) waste plastics and arylcarboxylic acid anhydride (generic).
Basis for action: The PMN states that the use of the PMN substance will be as a chemical intermediate (polyol) for use in the manufacture of polyurethane polymers. Based on the estimated physical/chemical properties of the PMN substance, comparison with structurally analogous chemical substances, test data on analogous substances, and SAR analysis on esters, EPA has identified concerns for lung effects, irritation to eye, mucous membranes and lung, anesthetization of the eye, developmental, renal and bladder toxicity, kidney toxicity, and renal cancer if the chemical substance is not used following the limitations noted. The condition of use of the PMN substance as described in the PMN includes the following protective measure:
No modification of manufacture, processing or use if it results in inhalation exposures to vapors, particulate, mist or aerosols.
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 in vitro skin irritation and eye damage testing using human derived cells would help characterize the potential health effects of the PMN substance.
CFR Citation: 40 CFR 721.11358.
Chemical Name: 1H-Pyrrole-2,5-dione, 1,1′-C36-alkylenebis-.
CAS Number: 1911605-95-2.
Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be as an adhesive component. Based on the available data for the new chemical substance, estimated physical/chemical properties of the PMN substance, and comparison with structurally analogous chemical substances, EPA has identified concerns for developmental toxicity and sensitization 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:
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 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 sensitization testing would help characterize the potential health effects of the PMN substance.
CFR Citation: 40 CFR 721.11359.
Chemical name: Benzenepropanal, .alpha.,.alpha.,3-trimethyl-.
CAS number: 107737-97-3.
Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the substance will be as an intermediate used for chemical production. Based on test data on the PMN substance and analogue data, EPA has identified concerns for sensitization and developmental toxicity. In addition, based on SAR analysis of test data on analogous neutral organics, EPA predicts toxicity to aquatic organisms may occur at concentrations greater than 99 ppb. The TSCA section 5(e) 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 TSCA section 5(e) Order requires:
No manufacture (including import) of the PMN substance beyond the confidential annual production volume specified in the TSCA section 5(e) Order.
Potentially useful information: EPA has determined that certain information 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 biodegradability, chronic aquatic toxicity, and reproductive toxicity testing would help EPA determine the potential human and environmental 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 721.11360.
Chemical name: Multiwalled carbon nanotubes (generic).
CAS number: Not available.Start Printed Page 54821
Effective date of TSCA section 5(e) Order: May 3, 2019.
Basis for TSCA section 5(e) Order: The PMN states that substance will be used in heat transfer, heat storage, thermal emission, and general temperature management in heat-generating systems such as electronics, to improve mechanical properties or electrical conductivities of other materials or products, and for light absorption properties. EPA has identified concerns for pulmonary toxicity based on carbon nanotube analogues. EPA has also identified concerns for aquatic toxicity when the substance is at low concentrations and in the presence of natural organic matter. The TSCA section 5(e) 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 TSCA section 5(e) Order requires:
The proposed SNUR designates 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 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 pulmonary toxicity and chronic aquatic toxicity testing would help EPA determine the potential human and environmental 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 721.11361.
Chemical Name: Polyolefin ester (generic).
Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be as a fuel additive. Based on the estimated physical/chemical properties of the PMN substance and comparison with structurally analogous substances, EPA has identified concerns for lung surfactancy and irritation to the eye and skin 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 involving an application method that generates a vapor, mist, or aerosol; and
2. No manufacture (including import) of the substance at less than the confidential average molecular weight identified in the PMN.
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 absorption, distribution, metabolism, and excretion (ADME)/toxicokinetic and lung toxicity testing would help characterize the potential health effects of the PMN substance.
CFR Citation: 40 CFR 721.11362.
Chemical Names: Isocyanic acid, polymethylenepolyphenylene ester, polymer with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol, polyetherpolyol, .alpha.,.alpha.′-[(1-methylethylidene)di-4,1-phenylene]bis[.omega.-hydroxypoly(oxy-1,2-ethanediyl)] and 1,2-propanediol, iso-Bu alc.- and 2-butoxyethanol- and 2-(2-butoxyethoxy)ethanol- and Et alc.- and methanol- and 1-methoxy-2-propanol-blocked (generic) (P-18-247); Isocyanic acid, polymethylenepolyphenylene ester, polymer with polyetherpolyol, 2-butoxyethanol- and 2-(2-butoxyethoxy)ethanol- and methanol-blocked (generic) (P-18-248); Isocyanic acid, polymethylenepolyphenylene ester, polymer with polyetherpolyol, 2-butoxyethanol- and 2-(2-butoxyethoxy)ethanol- and methanol- and 1-methoxy-2-propanol-blocked (generic) (P-18-249); Isocyanic acid, polymethylenepolyphenylene ester, polymer with polyetherpolyol, 2-butoxyethanol- and 2-(2-butoxyethoxy)ethanol- and 1(or 2)-(2-methoxymethylethoxy)propanol-blocked (generic) (P-18-250); Isocyanic acid, polymethylenepolyphenylene ester, 2-butoxyethanol- and 2-(2-butoxyethoxy)ethanol- and methanol- and 1(or 2)-(2-methoxymethylethoxy)propanol-blocked (generic) (P-18-251); Isocyanic acid, polymethylenepolyphenylene ester, 2-butoxyethanol- and 2-(2-butoxyethoxy)ethanol- and methanol- and 1-methoxy-2-propanol-blocked (generic) (P-18-252).
Basis for action: The PMNs state that the use of the PMN substances will be as crosslinkers for automotive electrocoats. Based on the physical/chemical properties, chemical structure of the substances, submitted data on the substances, and comparison to structurally analogous substances, EPA has identified concerns for lung effects, skin sensitization, 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 manufacture, processing, or use in a manner that results in inhalation exposure; and
2. No release of the PMN substance to surface waters exceeding 200 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 chronic ecotoxicity testing and lung effects tiered testing for surfactants would help characterize the potential health and environmental effects of the PMN substances.Start Printed Page 54822
CFR citations: 40 CFR 721.11363 (P-18-247); 40 CFR 721.11364 (P-18-248); 40 CFR 721.11365 (P-18-249); 40 CFR 721.11366 (P-18-250); 40 CFR 721.11367 (P-18-251); and 40 CFR 721.11368 (P-18-252).
Chemical Name: Fatty acid ester, polyether, diisocyanate polymer (generic).
Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be as an adhesive. Based on the estimated physical/chemical properties of the PMN substance, test data on an analogue of the residual isocyanate, and comparison with structurally analogous chemical substances, EPA has identified concerns for irritation/sensitization for the skin, eyes, mucous membrane, and lungs, and respiratory effects 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:
No manufacturing, processing, or use of the PMN substance containing greater than the confidential percentage of residual isocyanate identified in the PMN.
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 skin irritation, eye damage, skin sensitization, and pulmonary effects testing would help characterize the potential health effects of the PMN substance.
CFR Citation: 40 CFR 721.11369.
Chemical Name: Alkenoic acid, alkyl-, alkyl ester, polymer with alkyl alkenoate, substituted heteromonocycle, substituted carbomonocycle, substituted alkanediol and alkenoic acid, alkali metal salt (generic).
Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be as a component of ink. Based on the estimated physical/chemical properties of the PMN substance and comparison with structurally analogous chemical substances, EPA has identified lung effects if the chemical substance is not used following the limitations noted. The condition of use of the PMN substance as described in the PMN includes the following protective measure:
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 testing would help characterize the potential health effects of the PMN substance.
CFR Citation: 40 CFR 721.11370.
Chemical Name: Alkyl heteromonocycle with heteroatom substituted alkyl cycloalkane and 2-hydroxyethyl heteromonocycle methacrylate-blocked homopolymer (generic).
Basis for action: The PMN states that the use of the PMN substance will be as an immobilizing agent for the microbial promoter of nitrogen decomposition. Based on the estimated physical/chemical properties of the PMN substance and comparison with structurally analogous chemical substances, EPA has identified lung effects if the chemical substance is not used following the limitations noted. The condition of use of the PMN substance as described in the PMN includes the following protective measure:
No manufacture, processing, or use that results in inhalation exposures.
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 specific target organ toxicity including pulmonary effects testing would help characterize the potential health effects of the PMN substance.
CFR Citation: 40 CFR 721.11371.
Chemical Name: Phenol-formaldehyde epoxy, polymer with an alkyl polyether polysulfide (generic).
Effective date of TSCA section 5(e) Order: March 29, 2019.
Basis for TSCA section 5(e) Order: The PMN states that the use of the PMN substance will be as an adhesive for automotive parts. EPA identified concerns for reproductive/developmental toxicity, mutagenicity, and carcinogenicity for the low molecular weight components based on the epoxides chemical category and submitted test data. EPA also identified concerns for skin and lung sensitization and systematic toxicity based on the epoxide moieties. In addition, based on analysis of test data on the PMN substance and SAR analysis on analogous thiols/mercaptans, polyepoxides, and monoepoxides, EPA predicts chronic toxicity to aquatic organisms may occur at concentrations greater than 1 ppb. The TSCA section 5(e) 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 TSCA section 5(e) Order requires:
1. Use of personal protective equipment where there is a potential for dermal exposure;
2. Refraining from manufacture, processing or use of the PMN substance in a manner that would result in inhalation exposure;
3. No release of the PMN substance to surface waters exceeding 1 ppb; and
4. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS.
Potentially useful information: EPA has determined that certain information about the health and environmental 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 also determined that specific ecological hazard, reproductive/developmental toxicity, sensitization, and carcinogenicity effects testing of the Start Printed Page 54823PMN substance would be useful in determining the health and environmental effects of the PMN substance. Although the TSCA section 5(e) Order does not require these tests, 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 721.11372.
Chemical Name: Alkylphenol, reaction products with carbon dioxide, distn. residues from manuf. of alkylphenol derivs. and calcium alkylphenol derivs. (generic).
Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be as a lubricating additive. Based on the estimated physical/chemical properties of the PMN substance and comparison to structurally analogous chemical substances, EPA has identified concerns for irritation, sensitization, blood and liver toxicity, lung toxicity, and developmental 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 measure:
No use of the PMN substance involving an application method that generates a vapor, mist, or aerosol.
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 sensitization, irritation, target organ toxicity/pulmonary effects, and reproduction/developmental effects testing would help characterize the potential health effects of the PMN substance.
CFR Citation: 40 CFR 721.11373.
Chemical Name: Acetamide, 2-(4-methylphenoxy)-N-1H-pyrazol-3-yl-N-(2-thienylmethyl)-.
CAS Number: 1374760-95-8.
Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be as a fragrance. Based on the estimated physical/chemical properties of the PMN substance, available test data on the new chemical substance, and SAR analysis on analogous thiophenes, EPA has identified concerns for severe eye irritation, sensitization, lung effects, histopathological effects on the nasal passages, 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 domestic manufacture of the PMN substance; and
2. No release of the PMN substance to surface waters exceeding 15 ppb.
CFR Citation: 40 CFR 721.11374.
Chemical Names: Polyamines, reaction products with succinic anhydride polyalkenyl derivs., metal salts (generic) (P-19-54, chemical A) and Polyamines, reaction products with succinic anhydride polyalkenyl derivs., metal salts (generic) (P-19-54, chemical B).
Basis for action: The PMN states that the generic (non-confidential) use of the PMN substances will be as an automotive lubricant additive. Based on the available data for the new chemical substance, estimated physical/chemical properties of the PMN substances, comparison with structurally analogous chemical substances and other structural information, EPA has identified irritation to all tissues if the chemical substance is not used following the limitations noted. The conditions of use of the PMN substances as described in the PMN include the following protective measure:
Exceeding the concentration of the PMN substances in a formulated lubricant fluid for consumer use greater than the confidential percentage identified in the PMN.
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 skin and eye irritation testing would help characterize the potential health effects of the PMN substances.
CFR Citation: 40 CFR 721.11381 (P-19-54, chemical A) and 40 CFR 721.11382 (P-19-54, chemical B).
During review of the PMNs submitted for the chemical substances that are subject to these proposed SNURs, EPA concluded that for 8 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 23 chemical substances that are the subject of these SNURs and as further discussed in Unit IV, EPA identified certain circumstances different from the intended conditions of use that raised potential risk concerns. EPA determined that deviations from the protective measures 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 protective measures in the submission.
EPA is proposing these SNURs for specific chemical substances which Start Printed Page 54824have undergone premanufacture review because the Agency wants:
To review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing or processing a listed chemical substance for the described significant new use.
To either determine that the prospective manufacture or processing is not likely to present an unreasonable risk, or to take necessary regulatory action associated with any other determination, before the described significant new use of the chemical substance occurs.
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 8 of the 31 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 25 of the 31 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 October 11, 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 as of that date would have to cease any such activity upon the effective date of the final rule. To resume their activities, these persons would have to first comply with all applicable SNUR notification requirements and wait until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required with that determination.
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 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 can 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 identified for this rulemaking under ADDRESSES.
Additional information about these statutes and Executive Orders can be found at https://www.epa.gov/​laws-regulations-and-executive-orders. Start Printed Page 54825
This proposed rule would establish SNURs for several new chemical substances that were the subject of PMNs and TSCA section 5(e) Orders. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011).
Send any comments about the accuracy of the burden estimate, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, to the Director, Regulatory Support Division, Office of Mission Support (2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001. Please remember to include the OMB control number in any correspondence, but do not submit any completed forms to this address.
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, 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.
This action 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 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 action 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.
Start List of Subjects Start Printed Page 54826
Authority: 15 U.S.C. 2604, 2607, 2613, and 2625(c).
2. Add §§ 721.11346 through 721.11374, 721.11381 and 721.11382 to subpart E to read as follows:
721.11346
Perfluoropolyether halide (generic).
721.11347
Perfluoropolyether aryl (generic).
721.11348
Substituted aryl-perfluoropolyether (generic).
721.11349
Sulfonated perfluoropolyether aromatic transition metal salt (generic).
721.11350
Sulfonated perfluoropolyether aryl alkali metal salt (generic).
721.11351
Cyclohexanol, 4-ethylidene-2-propoxy- (P-16-225, chemical A).
721.11352
Cyclohexanol, 5-ethylidene-2-propoxy- (P-16-225, chemical B).
721.11353
Ethanone, 1-(5-propyl-1,3-benzodioxol-2-yl)-.
721.11354
Endcapped polysiloxane (generic).
721.11355
2,7-Nonadien-4-ol, 4,8-dimethyl-.
721.11356
Carbonodithioic acid, O-[2-[(dithiocarboxy)amino]-2-methylpropyl] ester, sodium salt (1:2).
721.11357
Oxirane, 2-methyl-, polymer with oxirane, methyl 2-(substituted carbomonocycle isoquinolin-2(3H)-yl) propyl ether (generic).
721.11358
Vegetable oil, polymers with diethylene glycol- and polyol- and polyethylene glycol-depolymd. poly(ethylene terephthalate) waste plastics and arylcarboxylic acid anhydride (generic).
721.11359
1H-Pyrrole-2,5-dione, 1,1′-C36-alkylenebis-.
721.11360
Benzenepropanal, .alpha.,.alpha.,3-trimethyl-.
721.11361
721.11362
Polyolefin ester (generic).
721.11363
Isocyanic acid, polymethylenepolyphenylene ester, polymer with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol, polyetherpolyol, .alpha.,.alpha.′-[(1-methylethylidene)di-4,1-phenylene]bis[.omega.-hydroxypoly(oxy-1,2-ethanediyl)] and 1,2-propanediol, iso-Bu alc.- and 2-butoxyethanol- and 2-(2-butoxyethoxy)ethanol- and Et alc.- and methanol- and 1-methoxy-2-propanol-blocked, (generic).
721.11364
Isocyanic acid, polymethylenepolyphenylene ester, polymer with polyetherpolyol, 2-butoxyethanol- and 2-(2-butoxyethoxy)ethanol- and methanol-blocked, (generic).
721.11365
Isocyanic acid, polymethylenepolyphenylene ester, polymer with polyetherpolyol, 2-butoxyethanol- and 2-(2-butoxyethoxy)ethanol- and methanol- and 1-methoxy-2-propanol-blocked (generic).
721.11366
Isocyanic acid, polymethylenepolyphenylene ester, polymer with polyetherpolyol, 2-butoxyethanol- and 2-(2-butoxyethoxy)ethanol- and 1(or 2)-(2-methoxymethylethoxy)propanol-blocked (generic).
721.11367
Isocyanic acid, polymethylenepolyphenylene ester, 2-butoxyethanol- and 2-(2-butoxyethoxy)ethanol- and methanol- and 1(or 2)-(2-methoxymethylethoxy)propanol-blocked (generic).
721.11368
Isocyanic acid, polymethylenepolyphenylene ester, 2-butoxyethanol- and 2-(2-butoxyethoxy)ethanol- and methanol- and 1-methoxy-2-propanol-blocked (generic).
721.11369
Fatty acid ester, polyether, diisocyanate polymer (generic).
721.11370
Alkenoic acid, alkyl-, alkyl ester, polymer with alkyl alkenoate, substituted heteromonocycle, substituted carbomonocycle, substituted alkanediol and alkenoic acid, alkali metal salt (generic).
721.11371
Alkyl heteromonocycle with heteroatom substituted alkyl cycloalkane and 2-hydroxyethyl heteromonocycle methacrylate-blocked homopolymer (generic).
721.11372
Phenol-formaldehyde epoxy, polymer with an alkyl polyether polysulfide (generic).
721.11373
Alkylphenol, reaction products with carbon dioxide, distn. residues from manuf. of alkylphenol derivs. and calcium alkylphenol derivs. (generic).
721.11374
Acetamide, 2-(4-methylphenoxy)-N-1H-pyrazol-3-yl-N-(2-thienylmethyl)-.
721.11375
721.11376
721.11377
721.11378
721.11379
721.11380
721.11381
Polyamines, reaction products with succinic anhydride polyalkenyl derivs. metal salts (generic) (P-19-54, chemical A).
721.11382
Polyamines, reaction products with succinic anhydride polyalkenyl derivs., metal salts (generic) (P-19-54, chemical B).
§ 721.11346
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as perfluoropolyether halide (PMN P-16-151) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(i) Hazard communication. Requirements as specified in § 721.72(a) through (d), (e) (concentration set at 1.0%), (f), (g)(3)(i), (ii), (4)(i), (iii), and (5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k) and (t). It is a significant new use to manufacture the substance for more than one year.
(iii) Disposal. Requirements as specified in § 721.85 (a)(1), (b)(1), and (c)(1). Incineration must be hazardous waste high temperature incineration where the treatment efficiency is no less than 99.99%.
(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a), (b), (c) and (f) through (k) are applicable to manufacturers and processors of this substance.
§ 721.11347
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as perfluoropolyether aryl (PMN P-16-152) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(i) Hazard Communication. Requirements as specified in § 721.72(a) through (d), (e) (concentration set at Start Printed Page 548271.0%), (f), (g)(3)(i), (ii), (4)(i), (iii), and (5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k) and (t).
§ 721.11348
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as substituted aryl-perfluoropolyether (PMN P-16-153) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
§ 721.11349
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as sulfonated perfluoropolyether aromatic transition metal salt (PMN P-16-154) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
§ 721.11350
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as sulfonated perfluoropolyether aryl alkali metal salt (PMN P-16-155) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
§ 721.11351
Cyclohexanol, 4-ethylidene-2-propoxy-(P-16-225, chemical A).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as cyclohexanol, 4-ethylidene-2-propoxy-(PMN P-16-225, chemical A; CAS No. 1631145-48-6) 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 (s)(10,000 kg). It is a significant new use to use other than as a fragrance and process the substance to greater than 10% in compounded fragrance oil formulations.Start Printed Page 54828
(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a), (b), and (i) are applicable to manufacturers and processors of this substance.
§ 721.11352
Cyclohexanol, 5-ethylidene-2-propoxy-(P-16-225, chemical B).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as cyclohexanol, 5-ethylidene-2-propoxy-(PMN P-16-225, chemical B; CAS No. 1631145-49-7) 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 (s)(10,000 kg). It is a significant new use to use other than as a fragrance and process the substance to greater than 10% in compounded fragrance oil formulations.
§ 721.11353
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as ethanone, 1-(5-propyl-1,3-benzodioxol-2-yl)-(PMN P-16-314, CAS No. 1370699-98-1) 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. Requirements as specified in § 721.80(f) and (s)(10,000 kg). It is a significant new use to exceed 10% of the PMN substance in processing formulations.
§ 721.11354
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as endcapped polysiloxane (PMN P-16-429) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
§ 721.11355
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 2,7-nonadien-4-ol, 4,8-dimethyl-(PMN P-16-470, CAS No. 103983-77-3) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(i) Release to water. Requirements as specified in § 721.90 (a)(4) and (b)(4) where N=113.
(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (c) and (k) are applicable to manufacturers and processors of this substance.
§ 721.11356
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as carbonodithioic acid, O-[2-[(dithiocarboxy)amino]-2-methylpropyl] ester, sodium salt (1:2) (PMN P-17-108; CAS No. 1947332-67-3) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(i) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) where N=2.
§ 721.11357
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance is identified generically as oxirane, 2-methyl-, polymer with oxirane, methyl 2-(substituted carbomonocycle isoquinolin-2(3H)-yl) propyl ether (PMN P-17-253) 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). It is a significant new use to process the substance to a concentration greater than 5% by weight in the final formulated product for any use.
(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (c), and (i) are applicable to manufacturers and processors of this substance.Start Printed Page 54829
§ 721.11358
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as vegetable oil, polymers with diethylene glycol- and polyol- and polyethylene glycol-depolymd. poly(ethylene terephthalate) waste plastics and arylcarboxylic acid anhydride (PMN P-18-91) 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 inhalation exposure to vapors, particulate, mist or aerosols.
§ 721.11359
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1H-pyrrole-2,5-dione, 1,1′-C36-alkylenebis-(PMN P-18-120, CAS No. 1911605-95-2) 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 substance in any manner that results in inhalation exposures.
§ 721.11360
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as benzenepropanal, .alpha.,.alpha.,3-trimethyl-(P-18-129; CAS No. 107737-97-3) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
§ 721.11361
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as multiwalled carbon nanotubes (PMN P-18-182) 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:
(i) embedded or incorporated into a polymer matrix that itself has been reacted (cured);
(ii) embedded in a permanent solid/polymer form that is not intended to undergo further processing, except mechanical processing; or
(iii) incorporated into an article as defined at 40 CFR 720.3(c).
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (3), when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and, (a)(4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible, (5)(respirators must provide a National Institute for Occupational Safety and Health assigned protection factor of at least 50), (6)(particulate), and (c).
(ii) Industrial, commercial, and consumer activities. It is a significant new use to use an application method that generates a dust, mist, or aerosol, unless such application method occurs in an enclosed process. It is a significant new use to use the substance other than for heat transfer, heat storage, thermal emission, and general temperature management in heat-generating systems such as electronics, to improve mechanical properties or electrical conductivities of other materials or products, and for light absorption properties.
(iii) Disposal. Requirements as specified in § 721.85 (a)(1), (2), (b)(1), (2), (c)(1), and (2).
§ 721.11362
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polyolefin ester (PMN P-18-186) 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 (y)(1). It is a significant new use to manufacture (including import) the substance at less than the confidential average molecular weight identified in the PMN.
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).Start Printed Page 54830
§ 721.11363
Isocyanic acid, polymethylenepolyphenylene ester, polymer with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol, polyetherpolyol, .alpha.,.alpha.′-[(1-methylethylidene)di-4,1-phenylene]bis[.omega.-hydroxypoly(oxy-1,2-ethanediyl)] and 1,2-propanediol, iso-Bu alc.- and 2-butoxyethanol- and 2-(2-butoxyethoxy)ethanol- and Et alc.- and methanol- and 1-methoxy-2-propanol-blocked (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as isocyanic acid, polymethylenepolyphenylene ester, polymer with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol, polyetherpolyol, .alpha.,.alpha.′-[(1- methylethylidene)di-4,1-phenylene]bis[.omega.-hydroxypoly(oxy-1,2-ethanediyl)] and 1,2-propanediol, iso-Bu alc.- and 2-butoxyethanol- and 2-(2-butoxyethoxy)ethanol- and Et alc.- and methanol- and 1-methoxy-2-propanol-blocked (PMN P-18-247) 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 substance in a manner results in inhalation exposure.
(ii) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) where N = 200.
§ 721.11364
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as isocyanic acid, polymethylenepolyphenylene ester, polymer with polyetherpolyol, 2-butoxyethanol- and 2-(2-butoxyethoxy)ethanol- and methanol-blocked, (PMN P-18-248) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
§ 721.11365
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as isocyanic acid, polymethylenepolyphenylene ester, polymer with polyetherpolyol, 2-butoxyethanol- and 2-(2-butoxyethoxy)ethanol- and methanol and 1-methoxy-2-propanol-blocked (PMN P-18-249) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
§ 721.11366
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as isocyanic acid, polymethylenepolyphenylene ester, polymer with polyetherpolyol, 2-butoxyethanol- and 2-(2-butoxyethoxy)ethanol- and 1(or 2)-(2-methoxymethylethoxy)propanol-blocked. (PMN P-18-250) 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 substance in a manner that results in inhalation exposure.
(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (c). (i), and (k) are applicable to manufacturers and processors of this substance.
§ 721.11367
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as isocyanic acid, polymethylenepolyphenylene ester, 2-butoxyethanol- and 2-(2-butoxyethoxy)ethanol- and methanol- Start Printed Page 54831and 1(or 2)-(2-methoxymethylethoxy)propanol-blocked (PMN P-18-251) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
§ 721.11368
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as isocyanic acid, polymethylenepolyphenylene ester, 2-butoxyethanol- and 2-(2-butoxyethoxy)ethanol- and methanol- and 1-methoxy-2-propanol-blocked. (PMN P-18-252) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
§ 721.11369
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as fatty acid ester, polyether, diisocyanate polymer (PMN P-18-282) 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 substance containing greater than the confidential residual isocyanate percentage identified in the PMN.
§ 721.11370
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkenoic acid, alkyl-, alkyl ester, polymer with alkyl alkenoate, substituted heteromonocycle, substituted carbomonocycle, substituted alkanediol and alkenoic acid, alkali metal salt (PMN P-18-305) 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 substance that results in inhalation exposures.
§ 721.11371
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkyl heteromonocycle with heteroatom substituted alkyl cycloalkane and 2-hydroxyethyl heteromonocycle methacrylate-blocked homopolymer (PMN P-18-339) 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 substance for any use that results in inhalation exposure.
§ 721.11372
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as phenol-formaldehyde epoxy, polymer with an alkyl polyether polysulfide (PMN P-19-5) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1) and (3).
(ii) Hazard communication. Requirements as specified in § 721.72 (a) through (d), (f), (g)(1)(iv), (vi), (vii), (skin and respiratory sensitization), (germ cell mutagenicity), (2)(i), (ii), (v), (3)(i), (ii), (4)(water release restrictions apply), and (5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.Start Printed Page 54832
(iii) Industrial, commercial, and consumer activities. It is a significant new use to manufacture, process, or use the PMN substance in any manner that results in inhalation exposure.
(iv) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) where N=1.
(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a) through (c), (f) through (i), and (k) are applicable to manufacturers and processors of this substance.
§ 721.11373
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkylphenol, reaction products with carbon dioxide, distn. residues from manuf. of alkylphenol derivs. and calcium alkylphenol derivs. (PMN P-19-20) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
§ 721.11374
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as acetamide, 2-(4-methylphenoxy)-N-1H-pyrazol-3-yl-N-(2-thienylmethyl)- (PMN P-19-35, CAS No. 1374760-95-8) 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).
(ii) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) where N=15.
§ 721.11375
§ 721.11376
§ 721.11377
§ 721.11378
§ 721.11379
§ 721.11380
§ 721.11381
Polyamines, reaction products with succinic anhydride polyalkenyl derivs., metal salts (generic) (P-19-54, chemical A).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polyamines, reaction products with succinic anhydride polyalkenyl derivs., metal salts (PMN P-19-54, chemical A) 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 exceed the confidential concentration percentage of the substance in a formulated lubricant fluid for consumer use identified in P-19-54.
§ 721.11382
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polyamines, reaction products with succinic anhydride polyalkenyl derivs., metal salts (PMN P-19-54, chemical B) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
[FR Doc. 2019-21720 Filed 10-10-19; 8:45 am]