83 FR 49806 - Significant New Use Rules on Certain Chemical Substances
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 83, Issue 192 (October 3, 2018)
Federal Register Volume 83, Issue 192 (October 3, 2018)
| Page Range | 49806-49826 | |
| FR Document | 2018-21194 |
[Federal Register Volume 83, Number 192 (Wednesday, October 3, 2018)] [Rules and Regulations] [Pages 49806-49826] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-21194] ======================================================================= ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 9 and 721 [EPA-HQ-OPPT-2018-0627; FRL-9983-82] RIN 2070-AB27 Significant New Use Rules on Certain Chemical Substances AGENCY: Environmental Protection Agency (EPA). ACTION: Direct final rule. ----------------------------------------------------------------------- SUMMARY: EPA is promulgating significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for 26 chemical substances which were the subject of premanufacture notices (PMNs). The chemical substances are subject to Orders issued by EPA pursuant to sections 5(e) and 5(f) of TSCA. This action requires persons who intend to manufacture (defined by statute to include import) or process any of these 26 chemical substances for an activity that is designated as a significant new use by this rule to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA's evaluation of the intended use 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 with that determination. DATES: This rule is effective on December 3, 2018. For purposes of [[Page 49807]] judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on October 17, 2018. Written adverse comments on one or more of these SNURs must be received on or before November 2, 2018 (see Unit VI. of the SUPPLEMENTARY INFORMATION). If EPA receives written adverse comments, on one or more of these SNURs before November 2, 2018, EPA will withdraw the relevant sections of this direct final rule before its effective date. For additional information on related reporting requirement dates, see Units I.A., VI., and VII. of the SUPPLEMENTARY INFORMATION. ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2018-0627, by one of the following methods:Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Mail: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001. Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: For technical information contact: Kenneth Moss, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 564-9232; email address: [email protected]. For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address: [email protected]. SUPPLEMENTARY INFORMATION: I. General Information A. Does this action apply to me? You may be potentially affected by this action if you manufacture, process, or use the chemical substances contained in this rule. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include: Manufacturers or processors of one or more subject chemical substances (NAICS codes 325 and 324110), e.g., chemical manufacturing and petroleum refineries. This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements promulgated at 19 CFR 12.118 through 12.127 and 19 CFR 127.28. Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA. Importers of chemicals subject to these SNURs must certify their compliance with the SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export a chemical substance that is the subject of this rule on or after November 2, 2018 are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see Sec. 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D. B. What should I consider as I prepare my comments for EPA? 1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. 2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html. II. Background A. What action is the Agency taking? 1. Direct Final Rule. EPA is promulgating these SNURs using direct final rule procedures. These SNURs will require persons to notify EPA at least 90 days before commencing the manufacture or processing of a chemical substance for any activity designated by these SNURs as a significant new use. Receipt of such notices obligates EPA to assess risks that may be associated with the significant new uses under the conditions of use and, if appropriate, to regulate the proposed uses before they occur. 2. Proposed Rule. In addition to this Direct Final Rule, elsewhere in this issue of the Federal Register, EPA is issuing a Notice of Proposed Rulemaking for this rule. If EPA receives no adverse comment, the Agency will not take further action on the proposed rule and the direct final rule will become effective as provided in this action. If EPA receives adverse comment on one or more of SNURs in this action by November 2, 2018 (see Unit VI. of the SUPPLEMENTARY INFORMATION), the Agency will publish in the Federal Register a timely withdrawal of the specific SNURs that the adverse comments pertain to, informing the public that the actions will not take effect. EPA would then address all adverse public comments in a response to comments document in a subsequent final rule, based on the proposed rule. B. What is the Agency's authority for taking this action? Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a ``significant new use.'' EPA must make this determination by rule after considering all relevant factors, including the four bulleted TSCA section 5(a)(2) factors listed in Unit III. Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1)(B) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture or process the chemical substance for that use (15 U.S.C. 2604(a)(1)(B)(i)). TSCA furthermore prohibits such manufacturing or processing from commencing until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required in association with that determination (15 U.S.C. 2604(a)(1)(B)(ii)). As described in Unit V., the general SNUR provisions are found at 40 CFR part 721, subpart A. [[Page 49808]] C. Applicability of General Provisions General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the rule. Provisions relating to user fees appear at 40 CFR part 700. According to Sec. 721.1(c), persons subject to these SNURs must comply with the same SNUN requirements and EPA regulatory procedures as submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these requirements include the information submission requirements of TSCA section 5(b) and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA must either determine that the significant new use is not likely to present an unreasonable risk of injury or take such regulatory action as is associated with an alternative determination before the manufacture or processing for the significant new use can commence. If EPA determines that the significant new use is not likely to present an unreasonable risk, EPA is required under TSCA section 5(g) to make public, and submit for publication in the Federal Register, a statement of EPA's findings. III. Significant New Use Determination Section 5(a)(2) of TSCA states that EPA's determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors, including: The projected volume of manufacturing and processing of a chemical substance. The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance. The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance. The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance. In addition to these factors enumerated in TSCA section 5(a)(2), the statute authorizes EPA to consider any other relevant factors. To determine what would constitute a significant new use for the 26 chemical substances that are the subject of these SNURs, EPA considered relevant information about the toxicity of the chemical substances, likely human exposures and environmental releases associated with possible uses, and the four bulleted TSCA section 5(a)(2) factors listed in this unit. IV. Substances Subject to This Rule EPA is establishing significant new use and recordkeeping requirements for 26 chemical substances in 40 CFR part 721, subpart E. In this unit, EPA provides the following information for each chemical substance: PMN number. Chemical name (generic name, if the specific name is claimed as CBI). Chemical Abstracts Service (CAS) Registry number (if assigned for non-confidential chemical identities). Basis for the TSCA section 5(e) or 5(f) Order. 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. This information may include testing required in a TSCA section 5(e) Order to be conducted by the PMN submitter, as well as testing not required to be conducted but which would also help characterize the potential health and/or environmental effects of the PMN substance. Any recommendation for information identified by EPA was made based on EPA's consideration of available screening-level data, if any, as well as other available information on appropriate testing for the chemical substance. Further, any such testing identified by EPA that includes testing on vertebrates was made after consideration of available toxicity information, computational toxicology and bioinformatics, and high-throughput screening methods and their prediction models. EPA also recognizes that whether testing/further information is needed will depend on the specific exposure and use scenario in the SNUN. EPA encourages all SNUN submitters to contact EPA to discuss any potential future testing. See Unit VIII. for more information. CFR citation assigned in the regulatory text section of this rule. The regulatory text section of these rules specifies the activities 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 rule, may be claimed as CBI. Unit IX. discusses a procedure companies may use to ascertain whether a proposed use constitutes a significant new use. These rules include 26 PMN substances that are subject to Orders under TSCA section 5(e)(1)(A) or section 5(f)(3)(A). Each Order is based on one or more of the findings in TSCA section 5(a)(3)(A) or section 5(a)(3)(B): There is insufficient information to permit a reasoned evaluation; in the absence of sufficient information to permit a reasoned evaluation, the activities associated with the PMN substances may present unreasonable risk to health or the environment; the substance is or will be produced in substantial quantities, and enters or may reasonably be anticipated to enter the environment in substantial quantities or there is or may be significant (substantial) human exposure to the substance; presents an unreasonable risk of injury to health or environment. Those Orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The SNURs 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). Where EPA determined that the PMN substance presents or may present an unreasonable risk of injury to human health via inhalation exposure, the underlying TSCA section 5(e) or 5(f) Order required, among other things, that potentially exposed employees wear specified respirators unless actual measurements of the workplace air show that air-borne concentrations of the PMN substance are below a New Chemical Exposure Limit (NCEL) that is established by EPA to provide adequate protection to human health. In addition to the actual NCEL concentration, the comprehensive NCELs provisions in TSCA section 5(e) Orders, which are modeled after Occupational Safety and Health Administration (OSHA) Permissible Exposure Limits (PELs) provisions, include requirements addressing performance criteria for sampling and analytical methods, periodic monitoring, respiratory protection, and recordkeeping. However, no comparable NCEL provisions currently exist in 40 CFR part 721, subpart B, for SNURs. Therefore, for these cases, the individual SNURs in 40 CFR part 721, subpart E, will state that persons subject to the SNUR who wish to pursue NCELs as an alternative to the Sec. 721.63 respirator requirements may request to do so under Sec. 721.30. EPA expects that persons whose Sec. 721.30 requests to use [[Page 49809]] the NCELs approach for SNURs that are approved by EPA will be required to comply with NCELs provisions that are comparable to those contained in the corresponding TSCA section 5(e) Order for the same chemical substance. PMN Number: P-10-366 Chemical name: Carbon nanomaterial (generic). CAS number: Not available. Effective date of TSCA section 5(e) Order: May 11, 2017. Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the substance will be in printing applications. EPA identified concerns for pulmonary toxicity and carcinogenicity based on analogy to carbon black. The Order was issued under TSCA sections 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 substance. The Order was also issued under TSCA section 5(e)(l)(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: 1. Submission to EPA of certain health testing and material characterization data before exceeding a specified confidential production volume; 2. Use of personal protective equipment where there is a potential for dermal exposure; 3. Use of a National Institute for Occupational Safety and Health (NIOSH) certified air purifying, tight-fitting full-face respirator equipped with N100, P-100, or R-100 filter with an Assigned Protection Factor (APF) of at least 50 where there is a potential for inhalation exposure; 4. No release of the PMN substance to surface waters; 5. Use of the PMN substance only for the confidential uses specified in the Order; 6. Limit the manufacture, processing and use of the PMN substance to industrial uses; 7. No processing or use of the powder form of the PMN substance outside of the site of manufacture/processing; and 8. No processing or use of the PMN substance in the liquid resin form using an application method that generates a vapor, mist, or aerosol. The SNUR designates as a ``significant new use'' the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the health effects of the PMN substance may be potentially useful to characterize the effects of the PMN 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 that will be designated by this SNUR. The submitter has agreed not to exceed certain time limits without performing specific physical-chemical property tests and characterization and pulmonary effects testing. EPA has also determined that the results of a carcinogenicity study would help characterize the potential health effects caused by the PMN substance. Although the Order does not require this test, the Order's restrictions will remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information. CFR citation: 40 CFR 721.11149. PMN Number: P-14-627 Chemical name: Cyclic amide (generic). CAS number: Not available. Effective date of TSCA section 5(e) Order: November 16, 2017. Basis for TSCA section 5(e) Order: The PMN states that the use of the substance will be in dispersions for industrial coatings (e.g., polyurethane, acrylic, epoxy), coating for consumer and professional use, adhesives and sealants, solvent-borne industrial coatings silicon wafer cleaning in microelectronics in clean rooms, photoresist stripping in microelectronics in clean rooms, coatings for microelectronics (e.g., casting of polymer films) in clean rooms, reaction medium for polymerization, polymer coatings for industrial and professional applications (e.g., wire enamel, non-stick and friction reduction coating) membranes, solvent for chemical synthesis reactions (e.g., pharmaceuticals), formulation of inks, industrial cleaner (e.g., cleaner for wind turbine, oil rigs, large engines), solvent for cleaning industrial reactors, wax inhibitors (in hydrocarbon lines), petrochemical extraction processes, paint stripper, solvents for production and formulation of fertilizer, solvent for production and formulation of active ingredients for agriculture, and solvent for formulation of active ingredients for agriculture-end use pesticide products. Based on test data on the PMN substance, EPA identified concerns for developmental and reproductive toxicity, skin irritation, and systemic toxicity. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(l)(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 health. 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 substance either enters 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 substance. To protect against these risks, the Order requires: 1. Use of personal protective where there is a potential for dermal exposures; 2. Refraining from domestic manufacture of the PMN substance in the United States (i.e., import only); 3. Import the PMN substance only according to the terms specified in the Order; 4. Use of the PMN substance only for the uses and concentrations specified in the Order; 5. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the Safety Data Sheet (SDS); 6. Processing and use of the PMN substance only for uses specified in the Order; and 7. No use of the PMN substance in hand held spray applications that generate a vapor, mist, or aerosol. The SNUR designates as a ``significant new use'' the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the fate of the PMN substance may be potentially useful to characterize the health effects of the PMN 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 that will be designated by this SNUR. Although the Order does not require these tests, the Order's restrictions will 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 721.11150. PMN Number: P-15-114 Chemical name: 2-Butanone 1,1,1,3,4,4,4-heptafluoro-3- (trifluoromethyl)-. CAS number: 756-12-7. Effective date of TSCA section 5(e) Order: December 13, 2017. Basis for TSCA section 5(e) Order: The PMN states that the use of the substance will be as a dielectric medium [[Page 49810]] for medium and high voltage power generation/distribution equipment and heat transfer. Based on analysis of test data on the PMN substance, EPA identified concerns for irritation of eyes, skin, lungs, and mucous membranes. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I) of TSCA, 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 health and the environment. To protect against these risks, the Order requires: 1. Use of personal protective equipment where there is a potential for dermal exposure; 2. Establishment and use of a hazard communication program, label containers of the PMN substance with the statement: ``contains a dielectric fluid which should not be mixed or used in conjunction with sulfur hexafluoride (SF6)'' and provide SDS and worker training in accordance with the provisions of the Hazard Communication Program section; 3. No manufacture of the PMN substance beyond a confidential annual production volume (which includes import) specified in the Order; 4. No use other than as a dielectric medium for medium and high voltage power generation/distribution equipment and heat transfer as described in the Order; and 5. No release of the PMN substance resulting in surface water concentrations that exceed 180 parts per billion (ppb). The SNUR designates as a ``significant new use'' the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the environmental and health effects of the PMN substance may be potentially useful to characterize the effects of the PMN 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 that will be designated by this SNUR. EPA has determined that the results of specific chronic aquatic toxicity and pulmonary effects testing would help characterize the potential environmental and health effects of the PMN substance. Although the 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 citation: 40 CFR 721.11151. PMN Number: P-15-320 Chemical names: Propanenitrile, 2,3,3,3 tetrafluoro- 2- (trifluoromethyl)-. CAS number: 42532-60-5. Effective date of TSCA section 5(e) Order: October 18, 2017. Basis for TSCA section 5(e) Order: The PMN states that the use of the substance will be as a dielectric medium for medium and high voltage power generation and distribution equipment. Based on analysis of test data on the PMN substance, EPA identified concerns for neurotoxicity and irritation of eyes, skin, lungs, and mucous membranes. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I) of TSCA, 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 health. To protect against these risks, the Order requires: 1. Establishment and use of a hazard communication program, label containers of the PMN substance with the statement: ``contains a dielectric fluid which should not be mixed or used in conjunction with sulfur hexafluoride (SF6)'' and provide SDS and worker training in accordance with the provisions of the Hazard Communication Program section; and 2. Manufacturing, processing, or use as a dielectric medium for medium and high voltage power generation and distribution equipment as described in the PMN. The SNUR designates as a ``significant new use'' the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the health effects of the PMN substance may be potentially useful to characterize the effects of the PMN 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 that will be designated by this SNUR. EPA has determined that the results of specific pulmonary effects testing would help characterize the potential health effects of the PMN substance. Although the Order does not require this test, 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 citation: 40 CFR 721.11152. PMN Number: P-15-734 Chemical name: Polymeric sulfide (generic). CAS number: Not available. Effective date of TSCA section 5(e) Order: October 11, 2017. Basis for TSCA section 5(e) Order: The PMN states that the use of the substance will be for wastewater heavy metals removal. Based on physical/chemical properties of the PMN substance, EPA identified concerns for severe skin irritation, corrosion, neurotoxicity, developmental toxicity, and reproductive toxicity. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I) of TSCA, 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 health and the environment. The Order was also issued under TSCA sections 5(a)(3)(B)(ii)(II) and 5(e)(l)(A)(ii)(II), based on a finding that the substance is or will be produced in substantial quantities and that the substance either enters or may reasonable be anticipated to enter the environment in substantial quantities, or there is or may be significant (or substantial) human exposure to the chemical substance. To protect against these risks, the Order requires: 1. Submission of certain health testing on the PMN substance prior to exceeding the confidential production volume limit specified in the Order; 2. Use of personal protective equipment where there is a potential for dermal exposure; 3. No modification of the manufacturing, processing, or use activities of the PMN substance that result in inhalation exposure to workers; 4. Use of the PMN substance only for wastewater heavy metal removal as specified in the Order; 5. No release of the PMN substance resulting in surface water concentrations that exceed 2 ppb; and 6. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS. The SNUR designates as a ``significant new use'' the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the environmental and health effects of the PMN substance may be potentially useful to characterize the effects of the PMN 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 that will be designated by this SNUR. The submitter has agreed not to exceed a certain confidential production volume limit without performing reproductive/ [[Page 49811]] developmental toxicity testing and acute aquatic toxicity testing. CFR citation: 40 CFR 721.11153. PMN Numbers: P-16-356 and P-16-357 Chemical name: Quaternary ammonium salts (generic). CAS numbers: Not available. Effective date of TSCA section 5(e) Order: February 27, 2018. Basis for TSCA section 5(e) Order: The PMNs state that the generic (non-confidential) use of the substances will be as wellbore additives. EPA has identified concerns for irritation for the substances based on the pH and concerns for lung effects based on the surfactant properties. Based on analogy to cationic surfactants, EPA has identified ecotoxicity hazard concerns. 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 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 will be produced in substantial quantities and that the substances may reasonably be anticipated to enter the environment in substantial quantities and there may be significant human exposure to the PMN substances. To protect against these risks, the Order requires: 1. Use of personal protective equipment where there is potential for dermal exposure; 2. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS; 3. Refrain from manufacturing, processing or using the PMN substances in a manner that generates a vapor, mist, or aerosol; and 4. No use of the PMN substances other than the confidential use described in the Order. The SNUR designates as a ``significant new use'' the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the health and environmental effects of the PMN substances may be potentially useful to characterize the effects of the PMN substances 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 that will be designated by this SNUR. EPA has determined that the results of specific pulmonary effects testing would help characterize the potential health effects of the PMN substances and results of acute aquatic toxicity testing would help characterize the potential environmental effects of the PMN substances. Although the Order does not require this test, 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 citation: 40 CFR 721.11154. PMN Number: P-16-375 Chemical name: Alkyl methacrylates, polymer with olefins (generic). CAS number: Not available. Effective date of TSCA section 5(e) Order: October 17, 2017. Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the substance will be as a binder for seal application. Based on physical/chemical properties of the PMN substance, EPA identified concerns for lung toxicity. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I) of TSCA, 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 health and the environment. To protect against these risks, the Order requires: 1. Refraining from domestic manufacture of the PMN substance in the United States (i.e., import only); and 2. Import of the PMN substance according to the confidential molecular weight parameters specified in the Order. The SNUR designates as a ``significant new use'' the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the health and environmental effects of the PMN substance may be potentially useful to characterize the effects of the PMN 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 that will be designated by this SNUR. EPA has determined that the results of specific pulmonary effects testing and fate testing would help characterize the potential health effects of the PMN substance and results of acute aquatic toxicity testing would help characterize the potential environmental effects of the PMN substance. Although the Order does not require these tests, 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 citation: 40 CFR 721.11155. PMN Number: P-16-386 Chemical name: Hexanedioic acid, 1,6-bis(3,5,5-trimethylhexyl) ester. CAS number: 20270-50-2. Effective date of TSCA section 5(e) Order: October 12, 2017. Basis for TSCA section 5(e) Order: The PMN states that the substance will be used as a seal swell agent for motor formulations and gear oil lubricants. Based on analysis of an analogous compound, EPA has identified concerns for solvent neurotoxicity, liver and kidney effects, and concern for developmental toxicity based on analysis of testing for a potential degradant of the PMN substance. 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 health. To protect against these risks, the Order requires: 1. Submit to EPA certain toxicity testing prior to manufacturing 1,545,000 kilograms of the PMN substance; 2. Use of personal protective equipment where there is a potential for dermal exposure; 3. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS; and 4. Use of the PMN substance only for the use specified in the Order. The SNUR designates as a ``significant new use'' the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the health effects of the PMN substance may be potentially useful to characterize the effects of the PMN 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 that will be designated by this SNUR. The submitter has agreed not to exceed the 1,545,000 kilogram production volume limit without performing specific target organ/reproductive/developmental toxicity testing. CFR citation: 40 CFR 721.11156. PMN Number: P-16-396 Chemical name: Alkylaminium hydroxide (generic). CAS number: Not available. Effective date of TSCA section 5(e) Order: December 19, 2017. Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the PMN substance [[Page 49812]] will be as a specialty chemical for processing additive. Based on structural alerts and analysis of analogue data, EPA identified concerns for neurotoxicity, developmental and reproductive toxicity and irritation. EPA also identified concerns for lung effects based on surfactant properties and corrosivity and concern for reproductive and developmental toxicity based on analogue data from large quaternary ammonium compounds. 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 health. To protect against these risks, the Order requires: 1. Submission of certain health testing on the PMN substance prior to exceeding the confidential production volume limit as specified in the Order; 2. Use of personal protective equipment where there is a potential for dermal exposure; 3. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS; 4. No manufacturing, processing, or use of the PMN substance as a solid or powder; 5. Use of the PMN substance only for the confidential uses specified in the Order; and 6. No use of the PMN substance in application methods that generate a dust, vapor, mist, or aerosol. The SNUR designates as a ``significant new use'' the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the health effects of the PMN substance may be potentially useful to characterize the effects of the PMN 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 that will be designated by this SNUR. The submitter has agreed not to exceed a certain production volume limit without performing reproductive/developmental toxicity testing. CFR citation: 40 CFR 721.11157. PMN Numbers: P-16-572 and P-16-573 Chemical name: Polyamine polyacid adducts (generic). CAS numbers: Not available. Effective date of TSCA section 5(e) Order: September 27, 2017. Basis for TSCA section 5(e) Order: The PMNs state that the generic (non-confidential) use of the substances will be as adhesives for coatings. Based on physical chemical properties of the PMN substances, EPA identified potential concerns for lung toxicity and aquatic/ terrestrial toxicity if the PMN substances are manufactured in such a manner that they are amine terminated. The 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 health and environmental effects for the PMN substances. The Order was also issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I) of TSCA, 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 Order requires: 1. Manufacture of the PMN substances in a manner that they are not amine terminated in order to maintain water solubility levels below 1 ppb. The SNUR designates as a ``significant new use'' the absence of this protective measure. Potentially useful information: EPA has determined that certain information about the physical-chemical properties and health effects of the PMN substances may be potentially useful to characterize the effects of the PMN substances 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 that will be designated by this SNUR. EPA has determined that the results of specific physical-chemical property tests and target organ toxicity testing would help characterize the potential health effects of the PMN substances. Although the Order does not require these tests, 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 721.11158. PMN Numbers: P-17-24 and P-17-25 Chemical names: Aromatic isocyanate, polymer with alkyloxirane polymer with oxirane ether with alkyldiol (2:l), and alkyloxirane polymer with oxirane ether with alkyltriol (3:l) (generic) (P-17-24) and aromatic isocyanate polymer with alkyloxirane, alkyloxirane polymer with oxirane ether with alkanetriol and oxirane (generic) (P-17-25). CAS numbers: Not available. Effective date of TSCA section 5(f) Order: October 31, 2017. Basis for TSCA section 5(f) Order: The PMN states that the generic (non-confidential) use of the substances will be as urethane components. EPA identified concerns for oncogenicity based on physical chemical properties of the PMN substances, mutagenicity based on data for analogous chemicals, and respiratory and dermal sensitization and lung and mucous membrane irritation based on the isocyanate moiety. The Order was issued under sections 5(a)(3)(A) and 5(f)(1) of TSCA, based on a finding that the substances present an unreasonable risk of injury to human health. To protect against these risks, the Order requires: 1. Use of personal protective equipment where there is a potential for dermal exposure; 2. No manufacturing, processing, or use of the PMN substances in application methods that generate a vapor, dust, mist, or aerosol; 3. No use of the PMN substances in a consumer product; and 4. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS. The SNUR designates as a ``significant new use'' the absence of these protective measures. CFR citation: 40 CFR 721.11159 and 40 CFR 721.11160. PMN Number: P-17-148 Chemical name: Oils, Hedychium Flavescens. CAS number: 1902936-65-5. Effective date of TSCA section 5(e) Order: December 15, 2017. Basis for TSCA section 5(e) Order: The PMN states that the substance will be used as an odoriferous component of fragrance compounds. Based on test data on PMN constituents, EPA has identified concerns for oncogenicity, developmental toxicity, liver, kidney, and male reproductive effects. EPA also identified concern for sensitization based on submitted test data on the PMN mixture. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(II), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk on injury to health. To protect against these risks, the Order requires: 1. Use of personal protective equipment where there is a potential for dermal exposures; 2. Use of a NIOSH-certified respirator with an APF of at least 50 where there is a potential for inhalation exposures; 3. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS; [[Page 49813]] 4. Refraining from domestic manufacture of the PMN substance in the United States (i.e., import only); 5. Not manufacture the PMN substance beyond an annual production volume of 70 kilograms; 6. Not manufacture, process, or use the PMN substance in any manner or method that generates mist or aerosol; and 7. Not use the PMN substance other than as an odoriferous component of fragrance compounds. The SNUR designates as a ``significant new use'' the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the health effects of the PMN substance may be potentially useful to characterize the effects of the PMN 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 that will be designated by this SNUR. EPA has determined that the results of specific skin absorption, and chronic toxicity/carcinogenicity testing would help characterize the potential health effects of the PMN substance. Although the Order does not require these tests, 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 citation: 40 CFR 721.11161. PMN Number: P-17-174 Chemical name: Alkyltriethosysilylpolysiloxane (generic). CAS number: Not available. Effective date of TSCA section 5(e) Order: November 28, 2017. Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the substance will be as a plastic additive. Based on analysis of test data on analogous alkoxysilanes, EPA identified concerns for lung effects, irritation, developmental toxicity, and neurotoxicity. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I) of TSCA, 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 health. To protect against these risks, the Order requires: 1. Submission to EPA of certain health testing before manufacturing (including import) the aggregate confidential volume identified in the Order; 2. Use of personal protective equipment where there is a potential for dermal exposure; 3. No manufacturing or use of the PMN substance in application methods that generate a vapor, mist, or aerosol; 4. Refraining from domestic manufacture of the PMN substance in the United States (i.e., import only); 5. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS. The SNUR designates as a ``significant new use'' the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the health effects of the PMN substance may be potentially useful to characterize the effects of the PMN 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 that will be designated by this SNUR. The submitter has agreed not to exceed a confidential production volume limit without performing specific target organ toxicity testing. CFR citation: 40 CFR 721.11162. PMN Numbers: P-17-200 and P-17-204 Chemical names: 1,3-bis(substitutedbenzoyl)benzene (generic) (P-17- 200) and 1,4-bis(substitutedbenzoyl)benzene (generic) (P-17-204). CAS numbers: Not available. Effective date of TSCA section 5(e) Order: December 18, 2017. Basis for TSCA section 5(e) Order: The PMNs state that the use of the substances will be as monomers for high performance polymers. Based on analysis of test data on analogous chemical bisphenol A and predictions for polyphenols, EPA identified potential concerns for irritation to the eyes, lungs, and mucous membranes, liver and kidney effects, reproductive and developmental toxicity, sensitization, neurotoxicity, and aquatic/terrestrial toxicity. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I) of TSCA, 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 the health and the environment. To protect against these risks, the Order requires: 1. Use of personal protective equipment where there is a potential for dermal exposure; 2. Use of a NIOSH certified respirator with an APF of at least 50 where there is a potential for inhalation exposure; 3. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS; 4. Manufacture (including import) the PMN substances only in the form of a solid; 5. Refraining from domestic manufacture of the PMN substances in the United States (i.e., import only); 6. No manufacture (including import), processing, or use of the PMN substances with greater than 0.1% of the particle size distribution less than 10 microns; 7. No use other than as chemical intermediates; 8. No release of the PMN substances into the waters of the United States without application of an on-site wastewater treatment that reduces the concentration of PMN substances in wastewater below the limit of detection of 0.03 ppm, using the on-site wastewater treatment system with activated carbon adsorption; and 9. Disposal of the PMN substances by incineration. The SNURs designate as a ``significant new use'' the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the environmental and health effects of the PMN substances may be potentially useful to characterize the effects of the PMN substances 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 that will be designated by these SNURs. EPA has also determined that the results of specific reproductive toxicity testing, skin sensitization, and chronic aquatic toxicity testing would help characterize the potential human and environmental effects of the PMN substances. Although the Order does not require these tests, 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 citation: 40 CFR 721.11163 and 40 CFR 721.11164. PMN Number: P-17-205 Chemical name: Bis(fluorobenzoyl)benzene (generic). CAS number: Not available. Effective date of TSCA section 5(e) Order: December 18, 2017. Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the substance will [[Page 49814]] be as a monomer for high performance polymers. Based on physical/ chemical properties of the PMN substance (as described in the New Chemical Program's PBT category at 64 FR 60194; November 4, 1999) and test data on structurally similar substances, the PMN substance is a potentially persistent, bioaccumulative, and toxic (PBT) chemical. EPA has identified concern for eye irritation based on test data for an analogous chemical. Concerns for liver, kidney, blood effects and carcinogenicity were identified based on test data available for benzophenone. Based on experimental data of an analogous chemical, EPA has identified environmental hazard concerns. 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 PMN substance may present an unreasonable risk of injury to health and the environment. To protect against these risks, the Order requires: 1. Use of personal protective equipment where there is a potential for dermal exposure; 2. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS; 3. Refraining from domestic manufacture of the PMN substance in the United States (i.e., import only); 4. Manufacture of the PMN substance only in the form of a solid; 5. No manufacture of the PMN substance with greater than 0.1% of the particle size distribution less than 10 microns; 6. No use other than as a chemical intermediate; 7. Disposal of the PMN substance by incineration; and 8. No release of the PMN without application of an on-site wastewater treatment that reduces the concentration of the PMN in wastewater below the limit of detection of 0.03 ppm. The SNUR designates as a ``significant new use'' the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the environmental and health effects of the PMN substance may be potentially useful to characterize the effects of the PMN 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 that will be designated by this SNUR. EPA has also determined that the results of biodegradability testing, bioaccumulation testing, specific reproductive and developmental toxicity testing, and chronic aquatic toxicity testing would help characterize the potential human and environmental effects of the PMN substance. Although the Order does not require these tests, 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 citation: 40 CFR 721.11165. PMN Number: P-17-251 Chemical name: 1-H-Benz[DE] isoquinoline-1,3 (2H)-dione-2-(-alkyl- )- (-alkyl-amino-) (generic). CAS number: Not available. Effective date of TSCA section 5(e) Order: December 13, 2017. Basis for TSCA section 5(e) Order: The PMN states that the specific (non-confidential) use of the substance will be as tracer dye. Based on the physical/chemical properties of the PMN substance and data for structurally analogous chemical substances, EPA has identified concerns for mutagenicity and ocular irritation. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(II), based on finding that in the absence of sufficient information to permit a reasoned evaluation, the PMN substance may present an unreasonable risk of injury to health. To protect against these risks, the Order requires: 1. Use of personal protective equipment where there is a potential for exposure; 2. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS; 3. Refraining from domestic manufacture of the PMN substance in the United States (i.e., import only); and 4. No import, processing, or use of the PMN substance at a concentration greater than 0.4%. The SNUR designates as a ``significant new use'' the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the health effects of the PMN substance may be potentially useful to characterize the effects of the PMN 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 that will be designated by this SNUR. EPA has determined that the results of specific skin absorption testing and genetic toxicology testing would help characterize the potential health effects of the PMN substance. Although the Order does not require this test, 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 citation: 40 CFR 721.11166. PMN Number: P-17-296 Chemical name: Siloxanes and Silicones, di-Me, hydrogen-terminated, reaction products with acrylic acid and 2-ethyl-2-[(2-propen-1- yloxyl)methyl]-1,3-propanediol, polymers with chlorotrimethylsilane- iso-Pr alc.-sodium reaction products. CAS number: 2014386-23-1. Effective date of TSCA section 5(e) Order: November 14, 2017. Basis for TSCA section 5(e) Order: The PMN states that the use of the substance will be as a component of release coating mixture for paper and film. Based on analogy to acrylates, EPA identified concerns for dermal and respiratory sensitization, mutagenicity, oncogenicity, developmental toxicity, and irritation to all tissues. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I) of TSCA, 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 health. To protect against these risks, the Order requires: 1. Use of personal protective equipment where there is a potential for dermal exposure; 2. Use of a NIOSH certified respirator with an APF of at least 1,000 if used in a manner that generates a spray, mist, or aerosol and there is a potential for inhalation exposure; 3. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS; and 4. Refraining from domestic manufacture of the PMN substance in the United States (i.e., import only). The SNUR designates as a ``significant new use'' the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the health effects of the PMN substance may be potentially useful to characterize the effects of the PMN 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 that will be designated by this SNUR. EPA has determined that the results of specific reproductive/developmental toxicity testing, skin sensitization and genetic toxicology testing would help characterize the potential health effects of the PMN substance. Although the [[Page 49815]] Order does not require these tests, 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 citation: 40 CFR 721.11167. PMN Numbers: P-17-308 and P-17-309 Chemical names: 2-Pentanone, 2,2',2''-[O,O',O''- (ethenylsilylidyne)trioxime] (P-17-308) and 2-Pentanone, 2,2',2''- [O,O',O''-(methylsilylidyne)trioxime] (P-17-309). CAS numbers: 58190-62-8 (P-17-308) and 37859-55-5 (P-17-309). Effective date of TSCA section 5(e) Order: October 30, 2017. Basis for TSCA section 5(e) Order: The PMNs state that the use of the substances will be as crosslinkers for silicone sealants used in automotive and large appliance (white goods) manufacture and for silicone sealants used in auto repair shops. Based on hazard determination and available qualitative risk information, EPA has identified concerns for irritation, corrosion, sensitization; systemic effects to spleen, liver and bone marrow; developmental, reproductive, blood, and kidney toxicity; neurotoxicity, mutagenicity and oncogenicity. 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 health. To protect against these risks, the Order requires: 1. Submission to EPA of certain toxicity testing on P-17-308 before manufacturing the aggregate confidential production volume identified in the Order; 2. Provide personal protective equipment where there is a potential for dermal exposure; 3. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS; 4. Refraining from domestic manufacture of the PMN substances in the United States (i.e., import only); and 5. Not process or use the PMN substances in any application that creates vapor, mist or aerosol. The SNURs designate as a ``significant new use'' the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the health effects of the PMN substances may be potentially useful to characterize the effects of the PMN substances 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 that will be designated by these SNURs. The submitter has agreed not to exceed a confidential production volume limit without performing reproductive/developmental toxicity testing and skin sensitization testing on P-17-308. CFR citation: 40 CFR 721.11168 and 40 CFR 721.11169. PMN Number: P-17-321 Chemical name: Naphthalene trisulfonic acid sodium salt (generic). CAS number: Not available. Effective date of TSCA section 5(e) Order: October 25, 2017. Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the substance will be for monitoring of oil/ gas well performance. Based on physical/chemical properties of the PMN substance and analysis of test data on analogous chemicals, EPA identified concerns for developmental toxicity and interference with blood clotting via chelation of nutrient metals, dermal and lung irritation, and sensitization. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I) of TSCA, 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 health. To protect against these risks, the Order requires: 1. Submission to EPA of certain toxicity testing before manufacturing (including import) the confidential aggregate volume identified in the Order; 2. Use of personal protective equipment where there is a potential for dermal exposure and a NIOSH certified respirator with an APF of at least 50 where there is a potential for inhalation exposure; 3. No manufacturing, processing, or use of the PMN substance in any manner that generates a vapor, mist, or aerosol; 4. No manufacture (including import) or processing of the PMN substance beyond the confidential annual production volume specified in the Order; and 5. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS. The SNUR designates as a ``significant new use'' the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the health effects of the PMN substance may be potentially useful to characterize the effects of the PMN 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 that will be designated by this SNUR. The submitter has agreed not to exceed a confidential production volume limit without performing reproductive/developmental toxicity testing and skin sensitization testing. CFR citation: 40 CFR 721.11170. PMN Number: P-17-327 Chemical name: Polymer of aliphatic dicarboxylic acid and dicyclo alkane amine (generic). CAS number: Not available. Effective date of TSCA section 5(e) Order: October 18, 2017. Basis for TSCA section 5(e) Order: The PMN states that the use of the PMN substance will be for injection molding of special applications and in compounding. Based on physical/chemical properties of the PMN substance, there are no significant concerns for the PMN substance as described in the PMN submission. However, if the PMN substance is made differently, there could be concern for lung toxicity. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I) of TSCA, 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 health. To protect against these risks, the Order requires: 1. Manufacture (which under TSCA includes importing) the PMN substance to have an average molecular weight of no greater than 10,000 Daltons. The SNUR designates as a ``significant new use'' the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the health effects of the PMN substance may be potentially useful to characterize the effects of the PMN 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 that will be designated by this SNUR. EPA has also determined that the results of specific acute toxicity and pulmonary effects testing would help characterize the potential health effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission and review of this or other relevant information. CFR citation: 40 CFR 721.11171. [[Page 49816]] PMN Number: P-17-330 Chemical name: Hexanedioic acid, polymer with trifunctional polyol, 1,1'-methylenebis [isocyanatobenzene], and 2,2'-oxybis [ethanol] (generic). CAS number: Not available. Effective date of TSCA section 5(e) Order: November 13, 2017. Basis for TSCA section 5(e) Order: The PMN states that the use of the substance will be as a polyurethane which is cured and used in a sprocket for water treatment. Based on physical/chemical properties of the PMN substance, EPA identified concerns for irritation to the eye, skin, respiratory tract, and gastrointestinal tract and for potential dermal and respiratory sensitization. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I) of TSCA, 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 health. To protect against these risks, the Order requires: 1. Use of personal protective equipment where there is a potential for dermal exposure; 2. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS; 3. No manufacture, processing, or use of the PMN substance in any manner that generates a dust, mist, or aerosol; and 4. No use of the PMN substance in a consumer product or for commercial uses when the sealable goods or service could introduce the PMN material into a consumer setting. The SNUR designates as a ``significant new use'' the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the health effects of the PMN substance may be potentially useful to characterize the effects of the PMN 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 that will be designated by this SNUR. EPA has also determined that the results of specific skin sensitization testing would help characterize the potential health effects of the PMN substance. Although the Order does not require this test, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission and review of this or other relevant information. CFR citations: 40 CFR 721.11172. V. Rationale and Objectives of the Rule A. Rationale During review of the PMNs submitted for the chemical substances that are subject to these SNURs, EPA concluded that for all 26 chemical substances, regulation was warranted under TSCA section 5(e) or section 5(f), 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) or 5(f) Orders requiring the use of appropriate exposure controls were negotiated with the PMN submitters. The SNURs 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). B. Objectives EPA is issuing these SNURs for specific chemical substances which have undergone premanufacture review because the Agency wants to achieve the following objectives with regard to the significant new uses designated in this rule: EPA will receive notice of any person's intent to manufacture or process a listed chemical substance for the described significant new use before that activity begins. EPA will have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing or processing a listed chemical substance for the described significant new use. EPA will be able to 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. EPA will identify as significant new uses any manufacturing, processing, distribution in commerce, use, or disposal that does not conform to the restrictions imposed by the underlying Orders, consistent with TSCA section 5(f)(4). Issuance of a SNUR for a chemical substance does not signify that the chemical substance is listed on the TSCA Chemical Substance Inventory (TSCA Inventory). Guidance on how to determine if a chemical substance is on the TSCA Inventory is available on the internet at http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html. VI. Direct Final Procedures EPA is issuing these SNURs as a direct final rule. The effective date of this rule is December 3, 2018 without further notice, unless EPA receives written adverse comments before November 2, 2018. If EPA receives written adverse comments on one or more of these SNURs before November 2, 2018, EPA will withdraw the relevant sections of this direct final rule before its effective date. This rule establishes SNURs for a number of chemical substances. Any person who submits adverse comments must identify the chemical substance and the new use to which it applies. EPA will not withdraw a SNUR for a chemical substance not identified in the comment. VII. Applicability of the Significant New Use Designation To establish a significant new use, EPA must determine that the use is not ongoing. The chemical substances subject to this rule have undergone premanufacture review. In cases where EPA has not received a notice of commencement (NOC) and the chemical substance has not been added to the TSCA Inventory, no person may commence such activities without first submitting a PMN. Therefore, for chemical substances for which an NOC has not been submitted EPA concludes that the designated significant new uses are not ongoing. When chemical substances identified in this rule are added to the TSCA Inventory, EPA recognizes that, before the rule is effective, other persons might engage in a use that has been identified as a significant new use. However, TSCA section 5(e) or 5(f) Orders have been issued for all of the chemical substances, and the PMN submitters are prohibited by the TSCA section 5(e) and 5(f) Orders from undertaking activities which will be designated as significant new uses. The identities of 20 of the 26 chemical substances subject to this rule have been claimed as confidential and EPA has received no post-PMN bona fide submissions (per Sec. Sec. 720.25 and 721.11) 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 rule are ongoing. Therefore, EPA designates October 3, 2018 as the cutoff date for determining whether the new use is ongoing. The objective of EPA's approach has been to [[Page 49817]] ensure that a person could not defeat a SNUR by initiating a significant new use before the effective date of the direct final rule. Persons who begin commercial manufacture or processing of the chemical substances for a significant new use identified as of that date will have to cease any such activity upon the effective date of the final rule. To resume their activities, these persons will 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. VIII. Development and Submission of Information EPA recognizes that TSCA section 5 does not require developing any particular new information (e.g., generating test data) before submission of a SNUN. There is an exception: Development of test data is required where the chemical substance subject to the SNUR is also subject to a rule, order or consent agreement under TSCA section 4 (see TSCA section 5(b)(1)). 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 required or recommended testing for all of the listed SNURs. Descriptions of tests are provided for informational purposes. EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol selection. Furthermore, pursuant to TSCA section 4(h), which pertains to reduction of testing in vertebrate animals, EPA encourages consultation with the Agency on the use of alternative test methods and strategies (also called New Approach Methodologies, or NAMs), if available, to generate the recommended test data. EPA encourages dialog with Agency representatives to help determine how best the submitter can meet both the data needs and the objective of TSCA section 4(h). In certain of the TSCA section 5(e) Orders for the chemical substances regulated under this rule, EPA has established production or time limits in view of the lack of data on the potential health and environmental risks that may be posed by the significant new uses or increased exposure to the chemical substances. These limits cannot be exceeded unless the PMN submitter first submits the results of toxicity tests that would permit a reasoned evaluation of the potential risks posed by these chemical substances. The SNURs contain the same limits as the TSCA section 5(e) Orders. Exceeding these limits is defined as a significant new use. Persons who intend to exceed the limit must notify the Agency by submitting a SNUN at least 90 days in advance of commencement of non-exempt commercial manufacture or processing. Any request by EPA for the triggered and pended testing described in the Orders was made based on EPA's consideration of available screening-level data, if any, as well as other available information on appropriate testing for the PMN substances. Further, any such testing request on the part of EPA that includes testing on vertebrates was made after consideration of available toxicity information, computational toxicology and bioinformatics, and high-throughput screening methods and their prediction models. Potentially useful information identified in Unit IV. may not be the only means of addressing the potential risks of the chemical substance. However, submitting a SNUN without any test data may increase the likelihood that EPA will take action under TSCA section 5(e), particularly if satisfactory test results have not been obtained from a prior PMN or SNUN submitter. EPA recommends that potential SNUN submitters contact EPA early enough so that they will be able to conduct the appropriate tests. SNUN submitters should be aware that EPA will be better able to evaluate SNUNs which provide detailed information on the following: Human exposure and environmental release that may result from the significant new use of the chemical substances. Information on risks posed by the chemical substances compared to risks posed by potential substitutes. IX. Procedural Determinations By this rule, EPA is establishing certain significant new uses which have been claimed as CBI subject to Agency confidentiality regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a final determination or other disposition of the confidentiality claim under 40 CFR part 2 procedures, EPA is required to keep this information confidential. EPA promulgated a procedure to deal with the situation where a specific significant new use is CBI, at Sec. 721.1725(b)(1). Under these procedures a manufacturer or processor may request EPA to determine whether a proposed use would be a significant new use under the rule. The manufacturer or processor must show that it has a bona fide intent to manufacture or process the chemical substance and must identify the specific use for which it intends to manufacture or process the chemical substance. If EPA concludes that the person has shown a bona fide intent to manufacture or process the chemical substance, EPA will tell the person whether the use identified in the bona fide submission would be a significant new use under the rule. Since most of the chemical identities of the chemical substances subject to these SNURs are also CBI, manufacturers and processors can combine the bona fide submission under the procedure in Sec. 721.1725(b)(1) with that under Sec. 721.11 into a single step. If EPA determines that the use identified in the bona fide submission would not be a significant new use, i.e., the use does not meet the criteria specified in the rule for a significant new use, that person can manufacture or process the chemical substance so long as the significant new use trigger is not met. In the case of a production volume trigger, this means that the aggregate annual production volume does not exceed that identified in the bona fide submission to EPA. Because of confidentiality concerns, EPA does not typically disclose the actual production volume that constitutes the use trigger. Thus, if the person later intends to exceed that volume, a new bona fide submission would be necessary to determine whether that higher volume would be a significant new use. X. SNUN Submissions According to Sec. 721.1(c), persons submitting a SNUN must comply with the same notification requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in 40 CFR 720.50. SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in 40 CFR 720.40 and 721.25. E-PMN software is available electronically at http://www.epa.gov/opptintr/newchems. XI. Economic Analysis EPA has evaluated the potential costs of establishing SNUN requirements for potential manufacturers and processors [[Page 49818]] of the chemical substances subject to this rule. EPA's complete economic analysis is available in the docket under docket ID number EPA-HQ-OPPT-2018-0627. XII. Statutory and Executive Order Reviews A. Executive Order 12866 This action establishes SNURs for several new chemical substances that were the subject of PMNs and TSCA section 5(e) or 5(f) Orders. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled ``Regulatory Planning and Review'' (58 FR 51735, October 4, 1993). B. Paperwork Reduction Act (PRA) According to PRA (44 U.S.C. 3501 et seq.), an agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR part 9, and included on the related collection instrument or form, if applicable. EPA is amending the table in 40 CFR part 9 to list the OMB approval number for the information collection requirements contained in this action. This listing of the OMB control numbers and their subsequent codification in the CFR satisfies the display requirements of PRA and OMB's implementing regulations at 5 CFR part 1320. This Information Collection Request (ICR) was previously subject to public notice and comment prior to OMB approval, and given the technical nature of the table, EPA finds that further notice and comment to amend it is unnecessary. As a result, EPA finds that there is ``good cause'' under section 553(b)(3)(B) of the Administrative Procedure Act (5 U.S.C. 553(b)(3)(B)) to amend this table without further notice and comment. The information collection requirements related to this action have already been approved by OMB pursuant to PRA under OMB control number 2070-0012 (EPA ICR No. 574). This action does not impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average between 30 and 170 hours per response. This burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete, review, and submit the required SNUN. Send any comments about the accuracy of the burden estimate, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques, to the Director, Collection Strategies Division, Office of Environmental Information (2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001. Please remember to include the OMB control number in any correspondence, but do not submit any completed forms to this address. C. Regulatory Flexibility Act (RFA) On February 18, 2012, EPA certified pursuant to RFA section 605(b) (5 U.S.C. 601 et seq.), that promulgation of a SNUR does not have a significant economic impact on a substantial number of small entities where the following are true: 1. A significant number of SNUNs would not be submitted by small entities in response to the SNUR. 2. The SNUR submitted by any small entity would not cost significantly more than $8,300. A copy of that certification is available in the docket for this action. This action is within the scope of the February 18, 2012 certification. Based on the Economic Analysis discussed in Unit XI. and EPA's experience promulgating SNURs (discussed in the certification), EPA believes that the following are true: A significant number of SNUNs would not be submitted by small entities in response to the SNUR. Submission of the SNUN would not cost any small entity significantly more than $8,300. Therefore, the promulgation of the SNUR would not have a significant economic impact on a substantial number of small entities. D. Unfunded Mandates Reform Act (UMRA) Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or Tribal government will be impacted by this action. As such, EPA has determined that this action does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.). E. Executive Order 13132 This action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 10, 1999). F. Executive Order 13175 This action does not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This action does not significantly nor uniquely affect the communities of Indian Tribal governments, nor does it involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175, entitled ``Consultation and Coordination with Indian Tribal Governments'' (65 FR 67249, November 9, 2000), do not apply to this action. G. Executive Order 13045 This action is not subject to Executive Order 13045, entitled ``Protection of Children from Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997), because this is not an economically significant regulatory action as defined by Executive Order 12866, and this action does not address environmental health or safety risks disproportionately affecting children. H. Executive Order 13211 This action is not subject to Executive Order 13211, entitled ``Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001), because this action is not expected to affect energy supply, distribution, or use and because this action is not a significant regulatory action under Executive Order 12866. I. National Technology Transfer and Advancement Act (NTTAA) In addition, since this action does not involve any technical standards, NTTAA section 12(d) (15 U.S.C. 272 note), does not apply to this action. J. Executive Order 12898 This action does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898, entitled ``Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations'' (59 FR 7629, February 16, 1994). [[Page 49819]] XIII. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a ``major rule'' as defined by 5 U.S.C. 804(2). List of Subjects 40 CFR Part 9 Environmental protection, Reporting and recordkeeping requirements. 40 CFR Part 721 Environmental protection, Chemicals, Hazardous substances, Reporting and recordkeeping requirements. Dated: September 14, 2018. Jeffery T. Morris, Director, Office of Pollution Prevention and Toxics. Therefore, 40 CFR parts 9 and 721 are amended as follows: PART 9--[AMENDED] 0 1. The authority citation for part 9 continues to read as follows: Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003, 2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330, 1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j- 2, 300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542, 9601-9657, 11023, 11048. 0 2. In Sec. 9.1, add the following sections in numerical order under the undesignated center heading ``Significant New Uses of Chemical Substances'' to read as follows: Sec. 9.1 OMB approvals under the Paperwork Reduction Act. * * * * * ------------------------------------------------------------------------ OMB control 40 CFR citation No. ------------------------------------------------------------------------ * * * * * ------------------------------------------------------------------------ Significant New Uses of Chemical Substances ------------------------------------------------------------------------ * * * * * ------------------------------------------------------------------------ 721.11149............................................... 2070-0012 721.11150............................................... 2070-0012 721.11151............................................... 2070-0012 721.11152............................................... 2070-0012 721.11153............................................... 2070-0012 721.11154............................................... 2070-0012 721.11155............................................... 2070-0012 721.11156............................................... 2070-0012 721.11157............................................... 2070-0012 721.11158............................................... 2070-0012 721.11159............................................... 2070-0012 721.11160............................................... 2070-0012 721.11161............................................... 2070-0012 721.11162............................................... 2070-0012 721.11163............................................... 2070-0012 721.11164............................................... 2070-0012 721.11165............................................... 2070-0012 721.11166............................................... 2070-0012 721.11167............................................... 2070-0012 721.11168............................................... 2070-0012 721.11169............................................... 2070-0012 721.11170............................................... 2070-0012 721.11171............................................... 2070-0012 721.11172............................................... 2070-0012 ------------------------------------------------------------------------ * * * * * ------------------------------------------------------------------------ * * * * * PART 721--[AMENDED] 0 3. The authority citation for part 721 continues to read as follows: Authority: 15 U.S.C. 2604, 2607, and 2625(c). 0 4. Add Sec. 721.11149 to subpart E to read as follows: Sec. 721.11149 Carbon nanomaterial (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as carbon nanomaterial (P-10-366) 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 after they have been reacted (cured), incorporated or embedded into a polymer matrix that itself has been completely reacted (cured), embedded in a permanent solid polymer, metal, glass, or ceramic form, or completely embedded in an article as defined at 40 CFR 720.3(c). (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(2)(i)(ii), (a)(3), (a)(4), (a)(5) (respirators must provide a National Institute for Occupational Safety and Health certified air purifying, tight-fitting full-face respirator equipped with N100, P-100, or R-100 filter with an Assigned Protection Factor of at least 50), (a)(6)(particulate), (when determining which persons are reasonable likely to be exposed as required for Sec. 721.63(a)(1) and (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 exposures, where feasible), and (c). (ii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(k), (l), (q), and (y)(1)(when the substance is in liquid resin form). It is a significant new use to process or use the powder form of the substance outside of the site of manufacture or processing. (iii) Release to water. Requirements as specified in Sec. 721.90(a)(1), (b)(1), and (c)(1). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (e), (i), and (k) are applicable to manufacturers, importers, and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of this section. 0 5. Add Sec. 721.11150 to subpart E to read as follows: Sec. 721.11150 Cyclic amide (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as cyclic amide (P-14-627) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(2)(i)(butyl or silver shield gloves), (a)(2)(iv), (a)(3)(when determining which persons are reasonably likely to be exposed as required for Sec. 721.63(a)(1), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation shall be considered and implemented to prevent exposure, where feasible), (b)(concentration set at 1.0%), and (c). (ii) Hazard communication. Requirements as specified in Sec. 721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i), (ix), (g)(2)(i), (ii), (iii), (v), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized [[Page 49820]] System and OSHA Hazard Communication Standard may be used. (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(f) and (k)(dispersions for industrial coatings (e.g., polyurethane, acrylic, epoxy), coating for consumer and professional use, adhesives and sealants, solvent-borne industrial coatings silicon wafer cleaning in microelectronics in clean rooms, photoresist stripping in microelectronics in clean rooms, coatings for microelectronics (e.g., casting of polymer films) in clean rooms, reaction medium for polymerization, polymer coatings for industrial and professional applications (e.g., wire enamel, non-stick and friction reduction coating) membranes, solvent for chemical synthesis reactions (e.g., pharmaceuticals), formulation of inks, industrial cleaner (e.g., cleaner for wind turbine, oil rigs, large engines), solvent for cleaning industrial reactors, wax inhibitors (in hydrocarbon lines), petrochemical extraction processes, paint stripper, solvents for production and formulation of fertilizer, solvent for production and formulation of active ingredients for agriculture, and solvent for formulation of active ingredients for agriculture-end use pesticide product). It is a significant new use to import the substance other than in containers of 55 gallons or more when the concentration is greater than 5% by weight for any product either intended for sale or distribution for ``consumer'' use, including for use in ``consumer products'', or both intended for ``commercial use'' and rnade available to consumers for retail purchase of any kind. It is a significant new use to use in hand held spray applications that generate a vapor, mist, or aerosol. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (i). (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. 0 6. Add Sec. 721.11151 to subpart E to read as follows: Sec. 721.11151 2-Butanone 1,1,1,3,4,4,4-heptafluoro-3- (trifluoromethyl)-. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 2-Butanone 1,1,1,3,4,4,4-heptafluoro-3-(trifluoromethyl)- (P-15-114, CAS No 756- 12-7) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(2), and (a)(3)(when determining which persons are reasonable likely to be exposed as required for Sec. 721.63(a)(1), 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 exposures, where feasible), (b)(concentration set at 1.0%), and (c). (ii) Hazard communication. Requirements as specified in Sec. 721.72(a) through (d), (f), (g)(1)(i), (g)(2)(i)(v), (g)(3)(ii)(harmful to fish), (g)(4)(iii), and (g)(5). It is a significant new use unless containers of the PMN substance are labeled with the statement: ``contains a dielectric fluid which should not be mixed or used in conjunction with sulfur hexafluoride (SF6)''. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used. (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(t). It is a significant new use to use the substance other than as a dielectric medium for medium and high voltage power generation/distribution equipment and heat transfer. (iv) Release to water. Requirements as specified in Sec. 721.90(a)(4), (b)(4), and (c)(4) where N = 180. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (i) and (k) are applicable to manufacturers, importers, and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. 0 7. Add Sec. 721.11152 to subpart E to read as follows: Sec. 721.11152 Propanenitrile, 2,3,3,3 tetrafluoro- 2- (trifluoromethyl)-. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as propanenitrile, 2,3,3,3 tetrafluoro- 2-(trifluoromethyl)- (P-15-320, CAS No 42532-60-5) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Hazard communication. Requirements as specified in Sec. 721.72(a) through (e)(concentration set at 1%), (f), and (g)(5). It is a significant new use unless containers of the PMN substance are labeled with the statement: ``contains a dielectric fluid which should not be mixed or used in conjunction with sulfur hexafluoride (SF6)''). 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 Sec. 721.80. It is a significant new use to use the substance other than as a dielectric medium for medium and high voltage power generation and distribution equipment. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (c) and (f) through (i) are applicable to manufacturers, importers, and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 8. Add Sec. 721.11153 to subpart E to read as follows: Sec. 721.11153 Polymeric sulfide (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as polymeric sulfide (P-15-734) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(2)(i), (a)(3), (when determining which persons are reasonable likely to be exposed as required for Sec. 721.63(a)(1), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative [[Page 49821]] control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposures, where feasible), (b)(concentration set at 1%), and (c). (ii) Hazard communication. Requirements as specified in Sec. 721.72(a) through (e)(concentration set at 1%), (f), (g)(1)(i), (vi), (ix), (neurotoxicity), (g)(2)(i), (iii), (v), (g)(3)(i), (ii), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used. (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(k)(wastewater heavy metal removal) and (q). It is a significant new use to manufacture, process, or use the substance in any manner that results in inhalation exposure to workers. (iv) Release to water. Requirements as specified in Sec. 721.90(a)(4), (b)(4), and (c)(4) where N = 2. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (i) and (k) are applicable to manufacturers, importers, and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. 0 9. Add Sec. 721.11154 to subpart E to read as follows: Sec. 721.11154 Quaternary ammonium salts (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as quaternary ammonium salts (PMN P-16-356 and P-16-357) are 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 substances after they have been reacted (cured). (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified Sec. 721.63(a)(1), (a)(2)(i), (a)(3), (when determining which persons are reasonably likely to be exposed as required for Sec. 721.63(a)(1), 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), (b)(concentration set at 1.0%), and (c). (ii) Hazard communication. Requirements as specified in Sec. 721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i), (ii), (neurotoxicity), (g)(2)(i), (iii), (v), (g)(3)(i), (ii), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used. (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(k). It is a significant new use to manufacture, process, or use the substances in any manner way that results in generation of a vapor, mist or aerosol. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (i). (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 10. Add Sec. 721.11155 to subpart E to read as follows: Sec. 721.11155 Alkyl methacrylates, polymer with olefins (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as alkyl methacrylates, polymer with olefins (P-16-375) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(f). It is a significant new use to import the substance other than according to the confidential molecular weight parameters specified in the Order for the substance. (ii) [Reserved] (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (c) and (i) are applicable to manufacturers, importers, and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of this section. 0 11. Add Sec. 721.11156 to subpart E to read as follows: Sec. 721.11156 Hexanedioic acid, 1,6-bis(3,5,5-trimethylhexyl) ester. (a) Chemical substance and significant new uses subject to reporting. (1) the chemical substance identified as hexanedioic acid, 1,6-bis(3,5,5-trimethylhexyl) ester (PMN P-16-386, CAS No 20270-50-2) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(3), (when determining which persons are reasonably likely to be exposed as required for Sec. 721.63(a)(1), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation shall be considered and implemented to prevent exposure, where feasible), (a)(6)(v), (vi), (particulate), (b)(concentration set at 1%), and (c). (ii) Hazard communication. Requirements as specified in Sec. 721.72(a) through (e)(concentration set at 1%), (f), (g)(1)(iii), (iv), (ix), (g)(2)(i), (ii), (iii), (v), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used. (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(k)(motor oil formulations and gear oil lubricants) and (p)(1,545,000 kilograms). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (i). (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 11. Add Sec. 721.11157 to subpart E to read as follows: Sec. 721.11157 Alkylaminium hydroxide (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkylaminium hydroxide (P-16-396) is subject to reporting under this section for the significant new uses [[Page 49822]] described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(2)(i), (ii), (iii), (iv), (a)(3), (when determining which persons are reasonably likely to be exposed as required for Sec. 721.63(a)(1), 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 exposures, where feasible), (b)(concentration set at 1%), and (c). (ii) Hazard communication. Requirements as specified in Sec. 721.71(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i), (ii), (iii), (vi), (ix), (eye damage), (g)(2)(i), (ii), (iii), (v), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used. (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(k), (q), (v)(1), (2), (w)(1), (2), (x)(1), (x)(2), (y)(1), and (y)(2). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (i) are applicable to manufacturers, importers, and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. 0 12. Add Sec. 721.11158 to subpart E to read as follows: Sec. 721.11158 Polyamine polyacid adducts (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances generically identified as polyamine polyacid adducts (P-16-572 and P-16-573) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80. It is a significant new to use to manufacture the substances in any manner other than they are not amine terminated in order to maintain water solubility levels below 1 part per billion. (ii) [Reserved] (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (c) and (i) are applicable to manufacturers, importers, and processors of these substances. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 13. Add Sec. 721.11159 to subpart E to read as follows: Sec. 721.11159 Aromatic isocyanate, polymer with alkyloxirane polymer with oxirane ether with alkyldiol (2:l) and alkyloxirane polymer with oxirane ether with alkyltriol (3:l) (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as aromatic isocyanate, polymer with alkyloxirane polymer with oxirane ether with alkyldiol (2:l) and alkyloxirane polymer with oxirane ether with alkyltriol (3:l) (P-17-24) 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 after they have been reacted (cured). (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(2)(i), (iv), (a)(3), (a)(6)(v), (vi), (particulate), (when determining which persons are reasonable likely to be exposed as required for Sec. 721.63(a)(1), 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 exposures, where feasible), (b)(concentration set at 0.1%), and (c). (ii) Hazard communication. Requirements as specified in Sec. 721.72(a) through (e)(concentration set at 0.1%), (f), (g)(1)(i), (ii), (asthma), (g)(2)(i), (ii), (iii), (v), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used. (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(o). It is a significant new use to manufacture, process, or use the substance in any manner that results in generation of a vapor, mist or aerosol. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (i) are applicable to manufacturers, importers, and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 14. Add Sec. 721.11160 to subpart E to read as follows: Sec. 721.11160 Aromatic isocyanate polymer with alkyloxirane, alkyloxirane polymer with oxirane ether with alkanetriol and oxirane (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as aromatic isocyanate polymer with alkyloxirane, alkyloxirane polymer with oxirane ether with alkanetriol and oxirane (P-17-25) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(2)(i), (iv), (a)(3), (a)(6)(v), (vi), (particulate), (when determining which persons are reasonable likely to be exposed as required for Sec. 721.63(a)(1), 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 exposures, where feasible), (b)(concentration set at 0.1%), and (c). (ii) Hazard communication. Requirements as specified in Sec. 721.72(a) through (e)(concentration set at 0.1%), (f), (g)(1)(i), (ii), (asthma), (g)(2)(i), (ii), (iii), (v), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used. (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(o). It is a significant new use to manufacture, process, or use the substance in any manner that results in generation of a vapor, mist or aerosol. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). [[Page 49823]] (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (i) are applicable to manufacturers, importers, and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 15. Add Sec. 721.11161 to subpart E to read as follows: Sec. 721.11161 Oils, Hedychium Flavescens. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as oils, hedychium flavescens, (PMN P-17-148, CAS No 1902936-65-5) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(2)(i), (iii), (iv), (a)(3), (a)(4), (when determining which persons are reasonably likely to be exposed as required for Sec. 721.63(a)(1) and (4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible), (a)(5)(respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor of at least 50), (a)(6)(v), (vi), (b)(concentration set at 1%), and (c). (ii) Hazard communication. Requirements as specified in Sec. 721.72(a) through (d), (f), (g)(1)(iv), (vi), (vii), (ix), (respiratory sensitization), (g)(2)(i), (ii), (iii), (iv), (v), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used. (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(f), (k)(odoriferous component of fragrance compounds) and (s)(70 kilograms). It is a significant new use to manufacture, process, or use the substance in any manner that generates a mist or aerosol. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 16. Add Sec. 721.11162 to subpart E to read as follows: Sec. 721.11162 Alkyltriethosysilylpolysiloxane (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as alkyltriethosysilylpolysiloxane (P-17-174) 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 after they have been reacted (cured). (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(2)(i), (a)(3), (when determining which persons are reasonable likely to be exposed as required for Sec. 721.63 (a)(1), 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 exposures, where feasible), and (c). (ii) Hazard communication. Requirements as specified in Sec. 721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i), (ix), (neurotoxicity), (g)(2)(i), (v), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used. (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(f) and (q). It is a significant new use to manufacture or use the substance in any manner that results in generation of a vapor, mist or aerosol. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (i) are applicable to manufacturers, importers, and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. 0 17. Add Sec. 721.11163 to subpart E to read as follows: Sec. 721.11163 1,3-Bis(substitutedbenzoyl)benzene. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as 1,3- bis(substitutedbenzoyl)benzene (P-17-200) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the PMN substance after they have been completely reacted (cured) or incorporated into a polymer matrix. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(2)(i), (iii), (iv), (a)(3), (a)(4), (a)(5)(respirators must provide a National Safety Institute for Occupational Safety and Health assigned protection factor of at least 50), (when determining which persons are reasonable likely to be exposed as required for Sec. 721.63(a)(1) and (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 exposures, where feasible), (b)(concentration set at 1.0%), and (c). (ii) Hazard communication. Requirements as specified in Sec. 721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i), (iii), (iv), (vi), (ix), (sensitization), (irritation to the eyes, lungs, and mucous membranes), (g)(2)(i), (ii), (iii), (iv), (v), (g)(3)(i), (ii), (g)(4)(i), (water release restriction apply), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used. (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(f), (g), (w)(3), and (w)(4). It is a significant new use to manufacture, process, or use of the PMN substance with greater than 0.1% of the particle size distribution less than 10 microns. (iv) Disposal requirements. Requirements as specified in Sec. 721.85(a)(1), (b)(1), and (c)(1). (v) Release to water. Requirements as specified in Sec. 721.90(a)(2)(iv), (b)(2)(iv), and (c)(2)(iv). The concentration in released wastewater must be less than 0.03 ppm. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in [[Page 49824]] Sec. 721.125(a) through (k) are applicable to manufacturers, importers, and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 18. Add Sec. 721.11164 to subpart E to read as follows: Sec. 721.11164 1,4-Bis(substitutedbenzoyl)benzene (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1,4- bis(substitutedbenzoyl)benzene (P-17-204) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the PMN substance after they have been completely reacted (cured) or incorporated into a polymer matrix. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(2)(i), (iii), (iv), (a)(3), (a)(4), (a)(5)(respirators must provide a National Safety Institute for Occupational Safety and Health assigned protection factor of at least 50), (when determining which persons are reasonable likely to be exposed as required for Sec. 721.63(a)(1), 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 exposures, where feasible), (b)(concentration set at 1.0%), and (c). (ii) Hazard communication. Requirements as specified in Sec. 721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i), (iii), (iv), (vi), (ix), (sensitization), (irritation to the eyes, lungs, and mucous membranes), (g)(2)(i), (ii), (iii), (iv), (v), (g)(3)(i), (ii), (g)(4)(i), (water release restriction apply), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used. (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(f), (g), (w)(3) and (4). It is a significant new use to manufacture, process, or use of the PMN substance with greater than 0.1% of the particle size distribution less than 10 microns. (iv) Disposal requirements. Requirements as specified in Sec. 721.85(a)(1), (b)(1), and (c)(1). (v) Release to water. Requirements as specified in Sec. 721.90(a)(2)(iv), (b)(2)(iv), and (c)(2)(iv). The concentration in released wastewater must be less than 0.03 ppm. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (k) are applicable to manufacturers, importers, and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 19. Add Sec. 721.11165 to subpart E to read as follows: Sec. 721.11165 bis(fluorobenzoyl)benzene (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as bis(fluorobenzoyl)benzene (P-17-205) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the PMN substance after they have been completely reacted (cured) or incorporated into a polymer matrix. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(2)(iii), (a)(3), (when determining which persons are reasonably likely to be exposed as required for Sec. 721.63(a)(1), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation shall be considered and implemented to prevent exposure, where feasible), (b)(concentration set at 1.0%), and (c). (ii) Hazard communication. Requirements as specified in Sec. 721.72(a) through (e)(concentration set at 1%), (f), (g)(1)(iv), (vii), (eye irritation), (g)(2)(i), (ii), (iii), (g)(3)(i), (ii), (g)(4)(i), (water release restriction apply), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used. (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(f), (g), (w)(3), and (w)(4). It is a significant new use to manufacture, process, or use of the PMN substance with greater than 0.1% of the particle size distribution less than 10 microns. (iv) Disposal. Requirements as specified in Sec. 721.85(a)(1), (b)(1), and (c)(1). (v) Release to water. Requirements as specified in Sec. 721.90(a)(2)(iv), (b)(2)(iv), and (c)(2)(iv). The concentration in released wastewater must be less than 0.03 ppm. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Record keeping requirements as specified in Sec. 721.125(a) through (k) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 20. Add Sec. 721.11166 to subpart E to read as follows: Sec. 721.11166 1-H-Benz[DE] isoquinoline-1,3 (2H)-dione-2-(-alkyl-)- (-alkyl-amino-) (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as 1-H- Benz[DE] isoquinoline-1,3 (2H)-dione-2-(-alkyl-)-(-alkyl-amino-) (P-17- 251) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(2)(i), (iii), (iv), (a)(3), (when determining which persons are reasonably likely to be exposed as required as Sec. 721.63(a)(1) engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation shall be considered and implemented to prevent exposure, where feasible), (a)(6)(v), (vi), (particulate), and (c). (ii) Hazard communication. Requirements as specified in Sec. 721.72(a) through (d), (f), (g)(1)(acute toxicity, mutagenicity, eye irritation), (g)(2)(i), (ii), (v), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used. (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(f). It is a significant new use to import, process, or use the PMN substance at a concentration greater than 0.4%. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (i) are applicable to [[Page 49825]] manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 21. Add Sec. 721.11167 to subpart E to read as follows: Sec. 721.11167 Siloxanes and Silicones, di-Me, hydrogen-terminated, reaction products with acrylic acid and 2-ethyl-2-[(2-propen-1- yloxyl)methyl]-1,3-propanediol, polymers with chlorotrimethylsilane- iso-Pr alc.-sodium reaction products. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as siloxanes and silicones, di-Me, hydrogen-terminated, reaction products with acrylic acid and 2-ethyl-2-[(2-propen-1-yloxyl)methyl]-1,3-propanediol, polymers with chlorotrimethylsilane-iso-Pr alc.-sodium reaction products (P-17-296, CAS No. 2014386-23-1) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the PMN substance after they have been completely reacted (cured). (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(2)(i), (ii), (iii), (a)(3), (a)(4), (a)(5), (respirators must provide a National Institute for Occupational Safety and Health assigned protection factor of at least 1,000 and are required for any process generating a spray, mist, or aerosol), (when determining which persons are reasonable likely to be exposed as required for Sec. 721.63(a)(1), 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 exposures, where feasible), (a)(6)(v), (vi), (particulate), (b)(concentration set at 1%), and (c). (ii) Hazard communication. Requirements as specified in Sec. 721.72(a) through (e)(concentration set at 1%), (f), (g)(1)(i), (sensitization) (iv), (vii), (ix), (g)(2)(i), (ii), (iii), (iv), (v), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used. (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(f). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (i) are applicable to manufacturers, importers, and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 22. Add Sec. 721.11168 to subpart E to read as follows: Sec. 721.11168 2-Pentanone, 2,2',2''-[O,O',O''- (ethenylsilylidyne)trioxime]. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance 2-pentanone, 2,2',2''-[O,O',O''- (ethenylsilylidyne)trioxime] (PMN P-17-308, CAS No. 58190-62-8) 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 after they have been completely reacted (cured). (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(2)(i), (a)(3), (when determining which persons are reasonably likely to be exposed as required for Sec. 721.63(a)(1), 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), (b)(concentration set at 1.0%), and (c). (ii) Hazard communication. Requirements as specified in Sec. 721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i), (iii), (iv), (vi), (vii), (viii), (ix), (g)(2)(i), (iii), (v), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System, and OSHA Hazard Communication Standard may be used. (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(f) and (q). It is a significant new use to process or use the substance involving a method that generates a vapor, mist, or aerosol. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping as specified in Sec. 721.125(a) through (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. 0 23. Add Sec. 721.11169 to subpart E to read as follows: Sec. 721.11169 2-Pentanone, 2,2',2''- [O,O',O''- (methylsilylidyne)trioxime]. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance 2-pentanone, 2,2',2''- [O,O',O''- (methylsilylidyne)trioxime] (PMN P-17-309, CAS No. 37859-55-5) 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 after they have been completely reacted (cured). (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(2)(i), (a)(3), (when determining which persons are reasonably likely to be exposed as required for Sec. 721.63(a)(1), 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), (b)(concentration set at 1%), and (c). (ii) Hazard communication. Requirements as specified in Sec. 721.72(a) through (e)(concentration set at 1%), (f), (g)(1)(i), (iii), (iv), (vi), (vii), (viii), (ix), (g)(2)(i), (iii), (v), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System, and OSHA Hazard Communication Standard may be used. (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(f) and (q). It is a significant new use to process or use the substance involving a method that generates a vapor, mist, or aerosol. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping as specified in Sec. 721.125(a) through (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. [[Page 49826]] (3) Determining whether a specific use is subject to this section. The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. 0 24. Add Sec. 721.11170 to subpart E to read as follows: Sec. 721.11170 Naphthalene trisulfonic acid sodium salt (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as naphthalene trisulfonic acid sodium salt (P-17-321) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(2)(i), (iv), (a)(3), (a)(4), (a)(5)(respirators must provide a National Institute for Occupational Safety and Health assigned protection factor of at least 50), (when determining which persons are reasonable likely to be exposed as required for Sec. 721.63(a)(1), 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 exposures, where feasible), (b)(concentration set at 1.0%), and (c). (ii) Hazard communication. Requirements as specified in Sec. 721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i), (ii), (iv), (ix), (g)(2)(i), (ii), (iii), (iv), (v), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used. (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(q) and (t). It is a significant new use to manufacture, process, or use the substance in any manner that generates a vapor, mist, or aerosol. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (i) are applicable to manufacturers, importers, and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. 0 25. Add Sec. 721.11171 to subpart E to read as follows: Sec. 721.11171 Polymer of aliphatic dicarboxylic acid and dicyclo alkane amine (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polymer of aliphatic dicarboxylic acid and dicyclo alkane amine (P-17-327) 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 after they have been reacted (cured). (2) The significant new uses are: (i) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80. It is a significant new use to manufacture (includes import) the substance to have an average molecular weight of greater than 10,000 Daltons. (ii) [Reserved] (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (c) and (i) are applicable to manufacturers, importers, and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 26. Add Sec. 721.11172 to subpart E to read as follows: Sec. 721.11172 Hexanedioic acid, polymer with trifunctional polyol, 1,1'-methylenebis [isocyanatobenzene], and 2,2'-oxybis [ethanol] (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as hexanedioic acid, polymer with trifunctional polyol, 1,1'-methylenebis [isocyanatobenzene], and 2,2'-oxybis [ethanol] (P-17-330) 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 after they have been reacted (cured). (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(2)(i), (ii), (iii), (iv), (a)(3), (when determining which persons are reasonable likely to be exposed as required for Sec. 721.63(a)(1), 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 exposures, where feasible), and (c). (ii) Hazard communication. Requirements as specified in Sec. 721.72(a) through (d), (f), (g)(1)(i), (eye and respiratory irritation), (g)(2)(i), (ii), (iii), (v), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used. (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80. It is a significant new use to manufacture, process, or use the substance for consumer use or for commercial uses that could introduce the substance into a consumer setting. It is a significant new use to manufacture, process, or use the substance in any manner that generates a dust, mist, or aerosol. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (i) are applicable to manufacturers, importers, and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. [FR Doc. 2018-21194 Filed 10-2-18; 8:45 am] BILLING CODE 6560-50-P
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value of all vested benefits that are not § 4044.10 Manner of allocation. excess of the value of the reduced
in pay status. The participant’s * * * * * benefit shall be reduced accordingly. In
estimated guaranteed benefit under (e) Allocating assets within priority the subcategory in which assets are
§ 4022.62(c) is $1,000 per month times categories. Except for priority categories exhausted, the assets shall be
0.65 (the factor from column (b) of Table 4 and 5, if the plan assets available for distributed among the participants
I in § 4022.62(c)(2)), or $650 per month. allocation to any priority category are according to the ratio that the value of
Multiplying $650 by the category 4 insufficient to pay for all benefits in that each participant’s benefit or benefits in
funding ratio of 2⁄3 (($2 million¥$1.5 priority category, those assets shall be that subcategory bears to the total value
million)/$0.75 million) produces an distributed among the participants of all benefits in that subcategory.
estimated category 4 benefit of $433.33 according to the ratio that the value of * * * * *
per month. each participant’s benefit or benefits in
(D) Because the estimated category 4 that priority category bears to the total § 4044.14 [Amended]
benefit so computed is less than the value of all benefits in that priority ■ 15. In § 4044.14, remove the word
estimated category 3 benefit so category. If the plan assets available for ‘‘phase-in’’ and add the word
computed, the estimated category 3 allocation to priority category 4 are ‘‘guarantee’’ in its place and remove the
benefit is the estimated asset-funded insufficient to pay for all benefits in that word ‘‘substantial’’ and add the word
benefit. Because the estimated category category, the assets shall be allocated, ‘‘majority’’ in its place.
3 benefit so computed is greater than the first, to the value of all participants’ Issued in Washington, DC.
estimated guaranteed benefit of $455 per nonforfeitable benefits that would be William Reeder,
month, in accordance with § 4022.61(d), assigned to priority category 4 other
the benefit payable to the participant is Director, Pension Benefit Guaranty
than those impacted by the majority- Corporation.
the estimated priority category 3 benefit owner limitation under § 4022.26 of this
of $500 per month. [FR Doc. 2018–21551 Filed 10–2–18; 8:45 am]
chapter. If assets available for allocation
BILLING CODE 7709–02–P
to priority category 4 are sufficient to
PART 4043—REPORTABLE EVENTS fully satisfy the value of those other
AND CERTAIN OTHER NOTIFICATION benefits, the remaining assets shall then
REQUIREMENTS be allocated to the value of the benefits ENVIRONMENTAL PROTECTION
that would be guaranteed but for the AGENCY
■ 10. The authority citation for part
4043 continues to read as follows: majority-owner limitation. These
40 CFR Parts 9 and 721
remaining assets shall be distributed
Authority: 29 U.S.C. 1083(k), 1302(b)(3), among the majority owners according to [EPA–HQ–OPPT–2018–0627; FRL–9983–82]
1343. the ratio that the value of each majority
■ 11. In § 4043.2: RIN 2070–AB27
owner’s benefit that would be
■ a. Amend the introductory text by guaranteed but for the majority-owner Significant New Use Rules on Certain
removing the words ‘‘single-employer limitation bears to the total value of all Chemical Substances
plan, and substantial owner’’ and by benefits that would be guaranteed but
adding in their place the words ‘‘and for the majority-owner limitation. If the AGENCY: Environmental Protection
single-employer plan’’. plan assets available for allocation to Agency (EPA).
■ b. Add in alphabetical order a priority category 5 are insufficient to ACTION: Direct final rule.
definition for ‘‘Substantial owner’’. pay for all benefits in that category, the
The addition reads as follows: assets shall be allocated, first, to the SUMMARY: EPA is promulgating
value of each participant’s significant new use rules (SNURs) under
§ 4043.2 Definitions. the Toxic Substances Control Act
nonforfeitable benefits that would be
* * * * * assigned to priority category 5 under (TSCA) for 26 chemical substances
Substantial owner means a substantial § 4044.15 after reduction for the value of which were the subject of
owner as defined in section 4021(d) of benefits assigned to higher priority premanufacture notices (PMNs). The
ERISA. categories, based only on the provisions chemical substances are subject to
* * * * * of the plan in effect at the beginning of Orders issued by EPA pursuant to
the five-year period immediately sections 5(e) and 5(f) of TSCA. This
PART 4044—ALLOCATION OF preceding the termination date. If assets action requires persons who intend to
ASSETS IN SINGLE–EMPLOYER available for allocation to priority manufacture (defined by statute to
PLANS category 5 are sufficient to fully satisfy include import) or process any of these
the value of those benefits, assets shall 26 chemical substances for an activity
■ 12. The authority citation for part then be allocated to the value of the that is designated as a significant new
4044 continues to read as follows: benefit increase under the oldest use by this rule to notify EPA at least
Authority: 29 U.S.C. 1301(a), 1302(b)(3), amendment during the five-year period 90 days before commencing that
1341, 1344, 1362. immediately preceding the termination activity. The required notification
date, reduced by the value of benefits initiates EPA’s evaluation of the
§ 4044.2 [Amended]
assigned to higher priority categories intended use within the applicable
■ 13. In § 4044.2(a): (including higher subcategories in review period. Persons may not
■ a. Remove the words ‘‘irrevocable priority category 5). This allocation commence manufacture or processing
commitment’’ and add in their place the procedure shall be repeated for each for the significant new use until EPA
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words ‘‘irrevocable commitment, succeeding plan amendment within the has conducted a review of the notice,
majority owner’’; and five-year period until all plan assets made an appropriate determination on
■ b. Remove the words ‘‘substantial available for allocation have been the notice, and has taken such actions
owner,’’. exhausted. If an amendment decreased as are required with that determination.
■ 14. Amend § 4044.10 by revising benefits, amounts previously allocated DATES: This rule is effective on
paragraph (e) to read as follows: with respect to each participant in December 3, 2018. For purposes of
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![49814 Federal Register / Vol. 83, No. 192 / Wednesday, October 3, 2018 / Rules and Regulations
be as a monomer for high performance reproductive and developmental Order’s restrictions remain in effect
polymers. Based on physical/chemical toxicity testing, and chronic aquatic until the Order is modified or revoked
properties of the PMN substance (as toxicity testing would help characterize by EPA based on submission of this or
described in the New Chemical the potential human and environmental other relevant information.
Program’s PBT category at 64 FR 60194; effects of the PMN substance. Although CFR citation: 40 CFR 721.11166.
November 4, 1999) and test data on the Order does not require these tests, PMN Number: P–17–296
structurally similar substances, the PMN the Order’s restrictions remain in effect
substance is a potentially persistent, until the Order is modified or revoked Chemical name: Siloxanes and
bioaccumulative, and toxic (PBT) by EPA based on submission of this or Silicones, di-Me, hydrogen-terminated,
chemical. EPA has identified concern other relevant information. reaction products with acrylic acid and
for eye irritation based on test data for CFR citation: 40 CFR 721.11165. 2-ethyl-2-[(2-propen-1-yloxyl)methyl]-
an analogous chemical. Concerns for 1,3-propanediol, polymers with
PMN Number: P–17–251 chlorotrimethylsilane-iso-Pr alc.-sodium
liver, kidney, blood effects and
carcinogenicity were identified based on Chemical name: 1-H-Benz[DE] reaction products.
test data available for benzophenone. isoquinoline-1,3 (2H)-dione-2-(-alkyl-)- CAS number: 2014386–23–1.
Based on experimental data of an (-alkyl-amino-) (generic). Effective date of TSCA section 5(e)
analogous chemical, EPA has identified CAS number: Not available. Order: November 14, 2017.
Effective date of TSCA section 5(e) Basis for TSCA section 5(e) Order:
environmental hazard concerns. The
Order: December 13, 2017. The PMN states that the use of the
Order was issued under TSCA sections
Basis for TSCA section 5(e) Order: substance will be as a component of
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
The PMN states that the specific (non- release coating mixture for paper and
based on a finding that in the absence
confidential) use of the substance will film. Based on analogy to acrylates, EPA
of sufficient information to permit a
be as tracer dye. Based on the physical/ identified concerns for dermal and
reasoned evaluation, the PMN substance
chemical properties of the PMN respiratory sensitization, mutagenicity,
may present an unreasonable risk of
substance and data for structurally oncogenicity, developmental toxicity,
injury to health and the environment.
analogous chemical substances, EPA has and irritation to all tissues. The Order
To protect against these risks, the Order
identified concerns for mutagenicity was issued under TSCA sections
requires:
1. Use of personal protective and ocular irritation. The Order was 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I) of
equipment where there is a potential for issued under TSCA sections TSCA, based on a finding that in the
dermal exposure; 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(II), absence of sufficient information to
2. Establishment and use of a hazard based on finding that in the absence of permit a reasoned evaluation, the
communication program, including sufficient information to permit a substance may present an unreasonable
human health precautionary statements reasoned evaluation, the PMN substance risk of injury to health. To protect
on each label and in the SDS; may present an unreasonable risk of against these risks, the Order requires:
3. Refraining from domestic injury to health. To protect against these 1. Use of personal protective
manufacture of the PMN substance in risks, the Order requires: equipment where there is a potential for
the United States (i.e., import only); 1. Use of personal protective dermal exposure;
4. Manufacture of the PMN substance equipment where there is a potential for 2. Use of a NIOSH certified respirator
only in the form of a solid; exposure; with an APF of at least 1,000 if used in
5. No manufacture of the PMN 2. Establishment and use of a hazard a manner that generates a spray, mist, or
substance with greater than 0.1% of the communication program, including aerosol and there is a potential for
particle size distribution less than 10 human health precautionary statements inhalation exposure;
microns; on each label and in the SDS; 3. Establishment and use of a hazard
6. No use other than as a chemical 3. Refraining from domestic communication program, including
intermediate; manufacture of the PMN substance in human health precautionary statements
7. Disposal of the PMN substance by the United States (i.e., import only); and on each label and in the SDS; and
incineration; and 4. No import, processing, or use of the 4. Refraining from domestic
8. No release of the PMN without PMN substance at a concentration manufacture of the PMN substance in
application of an on-site wastewater greater than 0.4%. the United States (i.e., import only).
treatment that reduces the concentration The SNUR designates as a ‘‘significant The SNUR designates as a ‘‘significant
of the PMN in wastewater below the new use’’ the absence of these protective new use’’ the absence of these protective
limit of detection of 0.03 ppm. measures. measures.
The SNUR designates as a ‘‘significant Potentially useful information: EPA Potentially useful information: EPA
new use’’ the absence of these protective has determined that certain information has determined that certain information
measures. about the health effects of the PMN about the health effects of the PMN
Potentially useful information: EPA substance may be potentially useful to substance may be potentially useful to
has determined that certain information characterize the effects of the PMN characterize the effects of the PMN
about the environmental and health substance in support of a request by the substance in support of a request by the
effects of the PMN substance may be PMN submitter to modify the Order, or PMN submitter to modify the Order, or
potentially useful to characterize the if a manufacturer or processor is if a manufacturer or processor is
effects of the PMN substance in support considering submitting a SNUN for a considering submitting a SNUN for a
of a request by the PMN submitter to significant new use that will be significant new use that will be
modify the Order, or if a manufacturer designated by this SNUR. EPA has designated by this SNUR. EPA has
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or processor is considering submitting a determined that the results of specific determined that the results of specific
SNUN for a significant new use that will skin absorption testing and genetic reproductive/developmental toxicity
be designated by this SNUR. EPA has toxicology testing would help testing, skin sensitization and genetic
also determined that the results of characterize the potential health effects toxicology testing would help
biodegradability testing, of the PMN substance. Although the characterize the potential health effects
bioaccumulation testing, specific Order does not require this test, the of the PMN substance. Although the
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![Federal Register / Vol. 83, No. 192 / Wednesday, October 3, 2018 / Rules and Regulations 49815
Order does not require these tests, the considering submitting a SNUN for a substance in support of a request by the
Order’s restrictions remain in effect significant new use that will be PMN submitter to modify the Order, or
until the Order is modified or revoked designated by these SNURs. The if a manufacturer or processor is
by EPA based on submission of this or submitter has agreed not to exceed a considering submitting a SNUN for a
other relevant information. confidential production volume limit significant new use that will be
CFR citation: 40 CFR 721.11167. without performing reproductive/ designated by this SNUR. The submitter
developmental toxicity testing and skin has agreed not to exceed a confidential
PMN Numbers: P–17–308 and P–17–309
sensitization testing on P–17–308. production volume limit without
Chemical names: 2-Pentanone, CFR citation: 40 CFR 721.11168 and performing reproductive/developmental
2,2’,2’’-[O,O’,O’’- 40 CFR 721.11169. toxicity testing and skin sensitization
(ethenylsilylidyne)trioxime] (P–17–308) testing.
and 2-Pentanone, 2,2’,2’’- [O,O’,O’’- PMN Number: P–17–321
CFR citation: 40 CFR 721.11170.
(methylsilylidyne)trioxime] (P–17–309). Chemical name: Naphthalene
CAS numbers: 58190–62–8 (P–17– trisulfonic acid sodium salt (generic). PMN Number: P–17–327
308) and 37859–55–5 (P–17–309). CAS number: Not available. Chemical name: Polymer of aliphatic
Effective date of TSCA section 5(e) Effective date of TSCA section 5(e) dicarboxylic acid and dicyclo alkane
Order: October 30, 2017. Order: October 25, 2017. amine (generic).
Basis for TSCA section 5(e) Order: Basis for TSCA section 5(e) Order: CAS number: Not available.
The PMNs state that the use of the The PMN states that the generic (non- Effective date of TSCA section 5(e)
substances will be as crosslinkers for confidential) use of the substance will Order: October 18, 2017.
silicone sealants used in automotive and be for monitoring of oil/gas well Basis for TSCA section 5(e) Order:
large appliance (white goods) performance. Based on physical/ The PMN states that the use of the PMN
manufacture and for silicone sealants chemical properties of the PMN substance will be for injection molding
used in auto repair shops. Based on substance and analysis of test data on of special applications and in
hazard determination and available analogous chemicals, EPA identified compounding. Based on physical/
qualitative risk information, EPA has concerns for developmental toxicity and chemical properties of the PMN
identified concerns for irritation, interference with blood clotting via substance, there are no significant
corrosion, sensitization; systemic effects chelation of nutrient metals, dermal and concerns for the PMN substance as
to spleen, liver and bone marrow; lung irritation, and sensitization. The described in the PMN submission.
developmental, reproductive, blood, Order was issued under TSCA sections However, if the PMN substance is made
and kidney toxicity; neurotoxicity, 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I) of differently, there could be concern for
mutagenicity and oncogenicity. The TSCA, based on a finding that in the lung toxicity. The Order was issued
Order was issued under TSCA sections absence of sufficient information to under TSCA sections 5(a)(3)(B)(ii)(I) and
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), permit a reasoned evaluation, the 5(e)(l)(A)(ii)(I) of TSCA, based on a
based on a finding that in the absence substance may present an unreasonable finding that in the absence of sufficient
of sufficient information to permit a risk of injury to health. To protect information to permit a reasoned
reasoned evaluation, the substances may against these risks, the Order requires: evaluation, the substance may present
present an unreasonable risk of injury to 1. Submission to EPA of certain an unreasonable risk of injury to health.
health. To protect against these risks, toxicity testing before manufacturing To protect against these risks, the Order
the Order requires: (including import) the confidential requires:
1. Submission to EPA of certain aggregate volume identified in the 1. Manufacture (which under TSCA
toxicity testing on P–17–308 before Order; includes importing) the PMN substance
manufacturing the aggregate 2. Use of personal protective to have an average molecular weight of
confidential production volume equipment where there is a potential for no greater than 10,000 Daltons.
identified in the Order; dermal exposure and a NIOSH certified The SNUR designates as a ‘‘significant
2. Provide personal protective respirator with an APF of at least 50 new use’’ the absence of these protective
equipment where there is a potential for where there is a potential for inhalation measures.
dermal exposure; exposure; Potentially useful information: EPA
3. Establishment and use of a hazard 3. No manufacturing, processing, or has determined that certain information
communication program, including use of the PMN substance in any about the health effects of the PMN
human health precautionary statements manner that generates a vapor, mist, or substance may be potentially useful to
on each label and in the SDS; aerosol; characterize the effects of the PMN
4. Refraining from domestic 4. No manufacture (including import) substance in support of a request by the
manufacture of the PMN substances in or processing of the PMN substance PMN submitter to modify the Order, or
the United States (i.e., import only); and beyond the confidential annual if a manufacturer or processor is
5. Not process or use the PMN production volume specified in the considering submitting a SNUN for a
substances in any application that Order; and significant new use that will be
creates vapor, mist or aerosol. 5. Establishment and use of a hazard designated by this SNUR. EPA has also
The SNURs designate as a ‘‘significant communication program, including determined that the results of specific
new use’’ the absence of these protective human health precautionary statements acute toxicity and pulmonary effects
measures. on each label and in the SDS. testing would help characterize the
Potentially useful information: EPA The SNUR designates as a ‘‘significant potential health effects of the PMN
has determined that certain information
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new use’’ the absence of these protective substance. Although the Order does not
about the health effects of the PMN measures. require these tests, the Order’s
substances may be potentially useful to Potentially useful information: EPA restrictions remain in effect until the
characterize the effects of the PMN has determined that certain information Order is modified or revoked by EPA
substances in support of a request by the about the health effects of the PMN based on submission and review of this
PMN submitter to modify the Order, or substance may be potentially useful to or other relevant information.
if a manufacturer or processor is characterize the effects of the PMN CFR citation: 40 CFR 721.11171.
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PMN Number: P–17–330 V. Rationale and Objectives of the Rule existingchemicals/pubs/tscainventory/
index.html.
Chemical name: Hexanedioic acid, A. Rationale
polymer with trifunctional polyol, 1,1’- VI. Direct Final Procedures
During review of the PMNs submitted
methylenebis [isocyanatobenzene], and EPA is issuing these SNURs as a
for the chemical substances that are
2,2′-oxybis [ethanol] (generic). direct final rule. The effective date of
subject to these SNURs, EPA concluded
CAS number: Not available. that for all 26 chemical substances, this rule is December 3, 2018 without
Effective date of TSCA section 5(e) regulation was warranted under TSCA further notice, unless EPA receives
Order: November 13, 2017. section 5(e) or section 5(f), pending the written adverse comments before
Basis for TSCA section 5(e) Order: development of information sufficient to November 2, 2018.
The PMN states that the use of the make reasoned evaluations of the health If EPA receives written adverse
substance will be as a polyurethane or environmental effects of the chemical comments on one or more of these
which is cured and used in a sprocket substances. The basis for such findings SNURs before November 2, 2018, EPA
for water treatment. Based on physical/ is outlined in Unit IV. Based on these will withdraw the relevant sections of
chemical properties of the PMN findings, TSCA section 5(e) or 5(f) this direct final rule before its effective
substance, EPA identified concerns for Orders requiring the use of appropriate date.
irritation to the eye, skin, respiratory exposure controls were negotiated with This rule establishes SNURs for a
tract, and gastrointestinal tract and for the PMN submitters. number of chemical substances. Any
potential dermal and respiratory The SNURs identify as significant person who submits adverse comments
sensitization. The Order was issued new uses any manufacturing, must identify the chemical substance
under TSCA sections 5(a)(3)(B)(ii)(I) and processing, use, distribution in and the new use to which it applies.
5(e)(l)(A)(ii)(I) of TSCA, based on a commerce, or disposal that does not EPA will not withdraw a SNUR for a
finding that in the absence of sufficient conform to the restrictions imposed by chemical substance not identified in the
information to permit a reasoned the underlying Orders, consistent with comment.
evaluation, the substance may present TSCA section 5(f)(4). VII. Applicability of the Significant
an unreasonable risk of injury to health. New Use Designation
To protect against these risks, the Order B. Objectives
requires: To establish a significant new use,
EPA is issuing these SNURs for EPA must determine that the use is not
1. Use of personal protective specific chemical substances which
equipment where there is a potential for ongoing. The chemical substances
have undergone premanufacture review subject to this rule have undergone
dermal exposure; because the Agency wants to achieve premanufacture review. In cases where
2. Establishment and use of a hazard the following objectives with regard to EPA has not received a notice of
communication program, including the significant new uses designated in commencement (NOC) and the chemical
human health precautionary statements this rule: substance has not been added to the
on each label and in the SDS; • EPA will receive notice of any TSCA Inventory, no person may
3. No manufacture, processing, or use person’s intent to manufacture or commence such activities without first
of the PMN substance in any manner process a listed chemical substance for submitting a PMN. Therefore, for
that generates a dust, mist, or aerosol; the described significant new use before chemical substances for which an NOC
and that activity begins. has not been submitted EPA concludes
4. No use of the PMN substance in a • EPA will have an opportunity to that the designated significant new uses
consumer product or for commercial review and evaluate data submitted in a are not ongoing.
uses when the sealable goods or service SNUN before the notice submitter When chemical substances identified
could introduce the PMN material into begins manufacturing or processing a in this rule are added to the TSCA
a consumer setting. listed chemical substance for the Inventory, EPA recognizes that, before
The SNUR designates as a ‘‘significant described significant new use. the rule is effective, other persons might
new use’’ the absence of these protective • EPA will be able to either determine engage in a use that has been identified
measures. that the prospective manufacture or as a significant new use. However,
Potentially useful information: EPA processing is not likely to present an TSCA section 5(e) or 5(f) Orders have
has determined that certain information unreasonable risk, or to take necessary been issued for all of the chemical
about the health effects of the PMN regulatory action associated with any substances, and the PMN submitters are
substance may be potentially useful to other determination, before the prohibited by the TSCA section 5(e) and
characterize the effects of the PMN described significant new use of the 5(f) Orders from undertaking activities
substance in support of a request by the chemical substance occurs. which will be designated as significant
PMN submitter to modify the Order, or • EPA will identify as significant new new uses. The identities of 20 of the 26
if a manufacturer or processor is uses any manufacturing, processing, chemical substances subject to this rule
considering submitting a SNUN for a distribution in commerce, use, or have been claimed as confidential and
significant new use that will be disposal that does not conform to the EPA has received no post-PMN bona
designated by this SNUR. EPA has also restrictions imposed by the underlying fide submissions (per §§ 720.25 and
determined that the results of specific Orders, consistent with TSCA section 721.11) for a chemical substance
skin sensitization testing would help 5(f)(4). covered by this action. Based on this,
characterize the potential health effects Issuance of a SNUR for a chemical the Agency believes that it is highly
of the PMN substance. Although the substance does not signify that the
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unlikely that any of the significant new
Order does not require this test, the chemical substance is listed on the uses described in the regulatory text of
Order’s restrictions remain in effect TSCA Chemical Substance Inventory this rule are ongoing.
until the Order is modified or revoked (TSCA Inventory). Guidance on how to Therefore, EPA designates October 3,
by EPA based on submission and review determine if a chemical substance is on 2018 as the cutoff date for determining
of this or other relevant information. the TSCA Inventory is available on the whether the new use is ongoing. The
CFR citations: 40 CFR 721.11172. internet at http://www.epa.gov/opptintr/ objective of EPA’s approach has been to
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XIII. Congressional Review Act OMB control required for § 721.63(a)(1) and (4)
40 CFR citation
Pursuant to the Congressional Review No. engineering control measures (e.g.,
Act (5 U.S.C. 801 et seq.), EPA will enclosure or confinement of the
721.11152 ............................. 2070–0012 operation, general and local ventilation)
submit a report containing this rule and 721.11153 ............................. 2070–0012
other required information to the U.S. or administrative control measures (e.g.,
721.11154 ............................. 2070–0012
Senate, the U.S. House of 721.11155 ............................. 2070–0012 workplace policies and procedures)
Representatives, and the Comptroller 721.11156 ............................. 2070–0012 shall be considered and implemented to
General of the United States prior to 721.11157 ............................. 2070–0012 prevent exposures, where feasible), and
publication of the rule in the Federal 721.11158 ............................. 2070–0012 (c).
Register. This action is not a ‘‘major 721.11159 ............................. 2070–0012 (ii) Industrial, commercial, and
721.11160 ............................. 2070–0012 consumer activities. Requirements as
rule’’ as defined by 5 U.S.C. 804(2). 721.11161 ............................. 2070–0012 specified in § 721.80(k), (l), (q), and
List of Subjects 721.11162 ............................. 2070–0012 (y)(1)(when the substance is in liquid
721.11163 ............................. 2070–0012
40 CFR Part 9 721.11164 ............................. 2070–0012 resin form). It is a significant new use
721.11165 ............................. 2070–0012 to process or use the powder form of the
Environmental protection, Reporting substance outside of the site of
721.11166 ............................. 2070–0012
and recordkeeping requirements. 721.11167 ............................. 2070–0012 manufacture or processing.
40 CFR Part 721 721.11168 ............................. 2070–0012 (iii) Release to water. Requirements as
721.11169 ............................. 2070–0012 specified in § 721.90(a)(1), (b)(1), and
Environmental protection, Chemicals, 721.11170 ............................. 2070–0012 (c)(1).
Hazardous substances, Reporting and 721.11171 ............................. 2070–0012 (b) Specific requirements. The
recordkeeping requirements. 721.11172 ............................. 2070–0012 provisions of subpart A of this part
Dated: September 14, 2018. apply to this section except as modified
Jeffery T. Morris, * * * * * by this paragraph (b).
Director, Office of Pollution Prevention and (1) Recordkeeping. Recordkeeping
Toxics. requirements as specified in
Therefore, 40 CFR parts 9 and 721 are * * * * * § 721.125(a) through (e), (i), and (k) are
amended as follows: applicable to manufacturers, importers,
PART 721—[AMENDED] and processors of this substance.
PART 9—[AMENDED] (2) Limitations or revocation of
■ 3. The authority citation for part 721 certain notification requirements. The
■ 1. The authority citation for part 9 continues to read as follows: provisions of § 721.185 apply to this
continues to read as follows: Authority: 15 U.S.C. 2604, 2607, and section.
Authority: 7 U.S.C. 135 et seq., 136–136y; 2625(c). (3) Determining whether a specific use
15 U.S.C. 2001, 2003, 2005, 2006, 2601–2671; ■ 4. Add § 721.11149 to subpart E to is subject to this section. The provisions
21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 read as follows: of § 721.1725(b)(1) apply to paragraph
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, (a)(2)(ii) of this section.
1321, 1326, 1330, 1342, 1344, 1345 (d) and § 721.11149 Carbon nanomaterial ■ 5. Add § 721.11150 to subpart E to
(e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, (generic).
1971–1975 Comp. p. 973; 42 U.S.C. 241, read as follows:
(a) Chemical substance and
242b, 243, 246, 300f, 300g, 300g–1, 300g–2,
300g–3, 300g–4, 300g–5, 300g–6, 300j–1,
significant new uses subject to reporting. § 721.11150 Cyclic amide (generic).
300j–2, 300j–3, 300j–4, 300j–9, 1857 et seq., (1) The chemical substance identified (a) Chemical substance and
6901–6992k, 7401–7671q, 7542, 9601–9657, generically as carbon nanomaterial (P– significant new uses subject to reporting.
11023, 11048. 10–366) is subject to reporting under (1) The chemical substance identified
■ 2. In § 9.1, add the following sections this section for the significant new uses generically as cyclic amide (P–14–627)
in numerical order under the described in paragraph (a)(2) of this is subject to reporting under this section
undesignated center heading section. The requirements of this section for the significant new uses described in
‘‘Significant New Uses of Chemical do not apply to quantities of the paragraph (a)(2) of this section.
Substances’’ to read as follows: substance after they have been reacted (2) The significant new uses are:
(cured), incorporated or embedded into (i) Protection in the workplace.
§ 9.1 OMB approvals under the Paperwork a polymer matrix that itself has been Requirements as specified in
Reduction Act. completely reacted (cured), embedded § 721.63(a)(1), (a)(2)(i)(butyl or silver
* * * * * in a permanent solid polymer, metal, shield gloves), (a)(2)(iv), (a)(3)(when
glass, or ceramic form, or completely determining which persons are
OMB control embedded in an article as defined at 40 reasonably likely to be exposed as
40 CFR citation No. required for § 721.63(a)(1), engineering
CFR 720.3(c).
(2) The significant new uses are: control measures (e.g., enclosure or
* * * * * (i) Protection in the workplace. confinement of the operation, general
Requirements as specified in and local ventilation shall be considered
§ 721.63(a)(1), (a)(2)(i)(ii), (a)(3), (a)(4), and implemented to prevent exposure,
Significant New Uses of Chemical (a)(5) (respirators must provide a where feasible), (b)(concentration set at
Substances National Institute for Occupational 1.0%), and (c).
Safety and Health certified air purifying, (ii) Hazard communication.
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tight-fitting full-face respirator equipped Requirements as specified in § 721.72(a)
* * * * *
with N100, P–100, or R–100 filter with through (e)(concentration set at 1.0%),
an Assigned Protection Factor of at least (f), (g)(1)(i), (ix), (g)(2)(i), (ii), (iii), (v),
721.11149 ............................. 2070–0012 50), (a)(6)(particulate), (when and (g)(5). Alternative hazard and
721.11150 ............................. 2070–0012 determining which persons are warning statements that meet the
721.11151 ............................. 2070–0012 reasonable likely to be exposed as criteria of the Globally Harmonized
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control measures (e.g., workplace control measures (e.g., workplace (3) Determining whether a specific use
policies and procedures) shall be policies and procedures) shall be is subject to this section. The provisions
considered and implemented to prevent considered and implemented to prevent of § 721.1725(b)(1) apply to paragraph
exposures, where feasible), exposure where feasible), (a)(2)(i) of this section.
(b)(concentration set at 1%), and (c). (b)(concentration set at 1.0%), and (c). ■ 11. Add § 721.11156 to subpart E to
(ii) Hazard communication. (ii) Hazard communication. read as follows:
Requirements as specified in § 721.72(a) Requirements as specified in § 721.72(a)
through (e)(concentration set at 1%), (f), through (e)(concentration set at 1.0%), § 721.11156 Hexanedioic acid, 1,6-
(g)(1)(i), (vi), (ix), (neurotoxicity), (f), (g)(1)(i), (ii), (neurotoxicity), (g)(2)(i), bis(3,5,5-trimethylhexyl) ester.
(g)(2)(i), (iii), (v), (g)(3)(i), (ii), and (g)(5). (iii), (v), (g)(3)(i), (ii), and (g)(5). (a) Chemical substance and
Alternative hazard and warning Alternative hazard and warning significant new uses subject to reporting.
statements that meet the criteria of the statements that meet the criteria of the (1) the chemical substance identified as
Globally Harmonized System and OSHA Globally Harmonized System and OSHA hexanedioic acid, 1,6-bis(3,5,5-
Hazard Communication Standard may Hazard Communication Standard may trimethylhexyl) ester (PMN P–16–386,
be used. be used. CAS No 20270–50–2) is subject to
(iii) Industrial, commercial, and (iii) Industrial, commercial, and reporting under this section for the
consumer activities. Requirements as consumer activities. Requirements as significant new uses described in
specified in § 721.80(k)(wastewater specified in § 721.80(k). It is a paragraph (a)(2) of this section.
heavy metal removal) and (q). It is a significant new use to manufacture, (2) The significant new uses are:
significant new use to manufacture, process, or use the substances in any (i) Protection in the workplace.
process, or use the substance in any manner way that results in generation of Requirements as specified in
manner that results in inhalation a vapor, mist or aerosol. § 721.63(a)(1), (a)(3), (when determining
exposure to workers. (b) Specific requirements. The which persons are reasonably likely to
(iv) Release to water. Requirements as provisions of subpart A of this part be exposed as required for
specified in § 721.90(a)(4), (b)(4), and apply to this section except as modified § 721.63(a)(1), engineering control
(c)(4) where N = 2. by this paragraph (b). measures (e.g., enclosure or
(b) Specific requirements. The (1) Recordkeeping. Recordkeeping confinement of the operation, general
provisions of subpart A of this part requirements as specified in and local ventilation shall be considered
apply to this section except as modified § 721.125(a) through (i). and implemented to prevent exposure,
by this paragraph (b). (2) Limitations or revocation of where feasible), (a)(6)(v), (vi),
(1) Recordkeeping. Recordkeeping (particulate), (b)(concentration set at
certain notification requirements. The
requirements as specified in 1%), and (c).
provisions of § 721.185 apply to this
§ 721.125(a) through (i) and (k) are (ii) Hazard communication.
section.
applicable to manufacturers, importers, Requirements as specified in § 721.72(a)
and processors of this substance. ■ 10. Add § 721.11155 to subpart E to
read as follows: through (e)(concentration set at 1%), (f),
(2) Limitations or revocation of
(g)(1)(iii), (iv), (ix), (g)(2)(i), (ii), (iii), (v),
certain notification requirements. The § 721.11155 Alkyl methacrylates, polymer and (g)(5). Alternative hazard and
provisions of § 721.185 apply to this with olefins (generic). warning statements that meet the
section.
(a) Chemical substance and criteria of the Globally Harmonized
(3) Determining whether a specific use
significant new uses subject to reporting. System and OSHA Hazard
is subject to this section. The provisions
(1) The chemical substance generically Communication Standard may be used.
of § 721.1725(b)(1) apply to paragraph
identified as alkyl methacrylates, (iii) Industrial, commercial, and
(a)(2)(iii) of this section.
polymer with olefins (P–16–375) is consumer activities. Requirements as
■ 9. Add § 721.11154 to subpart E to
subject to reporting under this section specified in § 721.80(k)(motor oil
read as follows: for the significant new uses described in formulations and gear oil lubricants)
§ 721.11154 Quaternary ammonium salts paragraph (a)(2) of this section. and (p)(1,545,000 kilograms).
(generic). (2) The significant new uses are: (b) Specific requirements. The
(a) Chemical substance and (i) Industrial, commercial, and provisions of subpart A of this part
significant new uses subject to reporting. consumer activities. Requirements as apply to this section except as modified
(1) The chemical substances identified specified in § 721.80(f). It is a significant by this paragraph (b).
generically as quaternary ammonium new use to import the substance other (1) Recordkeeping. Recordkeeping
salts (PMN P–16–356 and P–16–357) are than according to the confidential requirements as specified in
subject to reporting under this section molecular weight parameters specified § 721.125(a) through (i).
for the significant new uses described in in the Order for the substance. (2) Limitations or revocation of
paragraph (a)(2) of this section. The (ii) [Reserved] certain notification requirements. The
requirements of this section do not (b) Specific requirements. The provisions of § 721.185 apply to this
apply to quantities of the substances provisions of subpart A of this part section.
after they have been reacted (cured). apply to this section except as modified ■ 11. Add § 721.11157 to subpart E to
(2) The significant new uses are: by this paragraph (b). read as follows:
(i) Protection in the workplace. (1) Recordkeeping. Recordkeeping
Requirements as specified requirements as specified in § 721.11157 Alkylaminium hydroxide
§ 721.63(a)(1), (a)(2)(i), (a)(3), (when § 721.125(a) through (c) and (i) are (generic).
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determining which persons are applicable to manufacturers, importers, (a) Chemical substance and
reasonably likely to be exposed as and processors of this substance. significant new uses subject to reporting.
required for § 721.63(a)(1), engineering (2) Limitations or revocation of (1) The chemical substance identified
control measures (e.g., enclosure or certain notification requirements. The generically as alkylaminium hydroxide
confinement of the operation, general provisions of § 721.185 apply to this (P–16–396) is subject to reporting under
and local ventilation) or administrative section. this section for the significant new uses
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![49822 Federal Register / Vol. 83, No. 192 / Wednesday, October 3, 2018 / Rules and Regulations
described in paragraph (a)(2) of this to maintain water solubility levels manner that results in generation of a
section. below 1 part per billion. vapor, mist or aerosol.
(2) The significant new uses are: (ii) [Reserved] (b) Specific requirements. The
(i) Protection in the workplace. (b) Specific requirements. The provisions of subpart A of this part
Requirements as specified in provisions of subpart A of this part apply to this section except as modified
§ 721.63(a)(1), (a)(2)(i), (ii), (iii), (iv), apply to this section except as modified by this paragraph (b).
(a)(3), (when determining which by this paragraph (b). (1) Recordkeeping. Recordkeeping
persons are reasonably likely to be (1) Recordkeeping. Recordkeeping requirements as specified in
exposed as required for § 721.63(a)(1), requirements as specified in § 721.125(a) through (i) are applicable to
engineering control measures (e.g., § 721.125(a) through (c) and (i) are manufacturers, importers, and
enclosure or confinement of the applicable to manufacturers, importers, processors of this substance.
operation, general and local ventilation) and processors of these substances. (2) Limitations or revocation of
or administrative control measures (e.g., (2) Limitations or revocation of certain notification requirements. The
workplace policies and procedures) certain notification requirements. The provisions of § 721.185 apply to this
shall be considered and implemented to provisions of § 721.185 apply to this section.
prevent exposures, where feasible), section. ■ 14. Add § 721.11160 to subpart E to
(b)(concentration set at 1%), and (c).
(ii) Hazard communication. ■ 13. Add § 721.11159 to subpart E to read as follows:
Requirements as specified in § 721.71(a) read as follows:
§ 721.11160 Aromatic isocyanate polymer
through (e) (concentration set at 1.0%), § 721.11159 Aromatic isocyanate, polymer with alkyloxirane, alkyloxirane polymer with
(f), (g)(1)(i), (ii), (iii), (vi), (ix), (eye with alkyloxirane polymer with oxirane oxirane ether with alkanetriol and oxirane
damage), (g)(2)(i), (ii), (iii), (v), and ether with alkyldiol (2:l) and alkyloxirane (generic).
(g)(5). Alternative hazard and warning polymer with oxirane ether with alkyltriol (a) Chemical substance and
statements that meet the criteria of the (3:l) (generic). significant new uses subject to reporting.
Globally Harmonized System and OSHA (a) Chemical substance and (1) The chemical substance generically
Hazard Communication Standard may significant new uses subject to reporting. identified as aromatic isocyanate
be used. (1) The chemical substance generically polymer with alkyloxirane, alkyloxirane
(iii) Industrial, commercial, and identified as aromatic isocyanate, polymer with oxirane ether with
consumer activities. Requirements as polymer with alkyloxirane polymer alkanetriol and oxirane (P–17–25) is
specified in § 721.80(k), (q), (v)(1), (2), with oxirane ether with alkyldiol (2:l) subject to reporting under this section
(w)(1), (2), (x)(1), (x)(2), (y)(1), and and alkyloxirane polymer with oxirane for the significant new uses described in
(y)(2). ether with alkyltriol (3:l) (P–17–24) is paragraph (a)(2) of this section.
(b) Specific requirements. The subject to reporting under this section (2) The significant new uses are:
provisions of subpart A of this part for the significant new uses described in (i) Protection in the workplace.
apply to this section except as modified paragraph (a)(2) of this section. The Requirements as specified in
by this paragraph (b). requirements of this section do not § 721.63(a)(1), (a)(2)(i), (iv), (a)(3),
(1) Recordkeeping. Recordkeeping apply to quantities of the substance after (a)(6)(v), (vi), (particulate), (when
requirements as specified in they have been reacted (cured). determining which persons are
§ 721.125(a) through (i) are applicable to (2) The significant new uses are: reasonable likely to be exposed as
manufacturers, importers, and (i) Protection in the workplace. required for § 721.63(a)(1), engineering
processors of this substance. Requirements as specified in control measures (e.g., enclosure or
(2) Limitations or revocation of
§ 721.63(a)(1), (a)(2)(i), (iv), (a)(3), confinement of the operation, general
certain notification requirements. The
(a)(6)(v), (vi), (particulate), (when and local ventilation) or administrative
provisions of § 721.185 apply to this
determining which persons are control measures (e.g., workplace
section.
reasonable likely to be exposed as policies and procedures) shall be
(3) Determining whether a specific use
required for § 721.63(a)(1), engineering considered and implemented to prevent
is subject to this section. The provisions
control measures (e.g., enclosure or exposures, where feasible),
of § 721.1725(b)(1) apply to paragraph
confinement of the operation, general (b)(concentration set at 0.1%), and (c).
(a)(2)(iii) of this section.
and local ventilation) or administrative (ii) Hazard communication.
■ 12. Add § 721.11158 to subpart E to
control measures (e.g., workplace Requirements as specified in § 721.72(a)
read as follows: policies and procedures) shall be through (e)(concentration set at 0.1%),
§ 721.11158 Polyamine polyacid adducts considered and implemented to prevent (f), (g)(1)(i), (ii), (asthma), (g)(2)(i), (ii),
(generic). exposures, where feasible), (iii), (v), and (g)(5). Alternative hazard
(a) Chemical substance and (b)(concentration set at 0.1%), and (c). and warning statements that meet the
significant new uses subject to reporting. (ii) Hazard communication. criteria of the Globally Harmonized
(1) The chemical substances generically Requirements as specified in § 721.72(a) System and OSHA Hazard
identified as polyamine polyacid through (e)(concentration set at 0.1%), Communication Standard may be used.
adducts (P–16–572 and P–16–573) is (f), (g)(1)(i), (ii), (asthma), (g)(2)(i), (ii), (iii) Industrial, commercial, and
subject to reporting under this section (iii), (v), and (g)(5). Alternative hazard consumer activities. Requirements as
for the significant new uses described in and warning statements that meet the specified in § 721.80(o). It is a
paragraph (a)(2) of this section. criteria of the Globally Harmonized significant new use to manufacture,
System and OSHA Hazard process, or use the substance in any
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(2) The significant new uses are:
(i) Industrial, commercial, and Communication Standard may be used. manner that results in generation of a
consumer activities. Requirements as (iii) Industrial, commercial, and vapor, mist or aerosol.
specified in § 721.80. It is a significant consumer activities. Requirements as (b) Specific requirements. The
new to use to manufacture the specified in § 721.80(o). It is a provisions of subpart A of this part
substances in any manner other than significant new use to manufacture, apply to this section except as modified
they are not amine terminated in order process, or use the substance in any by this paragraph (b).
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![49824 Federal Register / Vol. 83, No. 192 / Wednesday, October 3, 2018 / Rules and Regulations
§ 721.125(a) through (k) are applicable and (c)(2)(iv). The concentration in (v) Release to water. Requirements as
to manufacturers, importers, and released wastewater must be less than specified in § 721.90(a)(2)(iv), (b)(2)(iv),
processors of this substance. 0.03 ppm. and (c)(2)(iv). The concentration in
(2) Limitations or revocation of (b) Specific requirements. The released wastewater must be less than
certain notification requirements. The provisions of subpart A of this part 0.03 ppm.
provisions of § 721.185 apply to this apply to this section except as modified (b) Specific requirements. The
section. by this paragraph (b). provisions of subpart A of this part
■ 18. Add § 721.11164 to subpart E to (1) Recordkeeping. Recordkeeping apply to this section except as modified
read as follows: requirements as specified in by this paragraph (b).
§ 721.125(a) through (k) are applicable (1) Recordkeeping. Record keeping
§ 721.11164 1,4-
to manufacturers, importers, and requirements as specified in
Bis(substitutedbenzoyl)benzene (generic).
processors of this substance. § 721.125(a) through (k) are applicable
(a) Chemical substance and (2) Limitations or revocation of to manufacturers and processors of this
significant new uses subject to reporting. certain notification requirements. The substance.
(1) The chemical substance identified as provisions of § 721.185 apply to this (2) Limitations or revocation of
1,4-bis(substitutedbenzoyl)benzene (P– section. certain notification requirements. The
17–204) is subject to reporting under
■ 19. Add § 721.11165 to subpart E to provisions of § 721.185 apply to this
this section for the significant new uses
read as follows: section.
described in paragraph (a)(2) of this
section. The requirements of this section ■ 20. Add § 721.11166 to subpart E to
§ 721.11165 bis(fluorobenzoyl)benzene
do not apply to quantities of the PMN read as follows:
(generic).
substance after they have been (a) Chemical substance and § 721.11166 1-H-Benz[DE] isoquinoline-1,3
completely reacted (cured) or significant new uses subject to reporting. (2H)-dione-2-(-alkyl-)-(-alkyl-amino-)
incorporated into a polymer matrix. (1) The chemical substance generically (generic).
(2) The significant new uses are: (a) Chemical substance and
(i) Protection in the workplace. identified as bis(fluorobenzoyl)benzene
(P–17–205) is subject to reporting under significant new uses subject to reporting.
Requirements as specified in
this section for the significant new uses (1) The chemical substance generically
§ 721.63(a)(1), (a)(2)(i), (iii), (iv), (a)(3),
described in paragraph (a)(2) of this identified as 1-H-Benz[DE] isoquinoline-
(a)(4), (a)(5)(respirators must provide a
section. The requirements of this section 1,3 (2H)-dione-2-(-alkyl-)-(-alkyl-amino-)
National Safety Institute for
do not apply to quantities of the PMN (P–17–251) is subject to reporting under
Occupational Safety and Health
substance after they have been this section for the significant new uses
assigned protection factor of at least 50),
completely reacted (cured) or described in paragraph (a)(2) of this
(when determining which persons are
incorporated into a polymer matrix. section.
reasonable likely to be exposed as
(2) The significant new uses are: (2) The significant new uses are:
required for § 721.63(a)(1), engineering
control measures (e.g., enclosure or (i) Protection in the workplace. (i) Protection in the workplace.
confinement of the operation, general Requirements as specified in Requirements as specified in
and local ventilation) or administrative § 721.63(a)(1), (a)(2)(iii), (a)(3), (when § 721.63(a)(1), (a)(2)(i), (iii), (iv), (a)(3),
control measures (e.g., workplace determining which persons are (when determining which persons are
policies and procedures) shall be reasonably likely to be exposed as reasonably likely to be exposed as
considered and implemented to prevent required for § 721.63(a)(1), engineering required as § 721.63(a)(1) engineering
exposures, where feasible), control measures (e.g., enclosure or control measures (e.g., enclosure or
(b)(concentration set at 1.0%), and (c). confinement of the operation, general confinement of the operation, general
(ii) Hazard communication. and local ventilation shall be considered and local ventilation shall be considered
Requirements as specified in § 721.72(a) and implemented to prevent exposure, and implemented to prevent exposure,
through (e)(concentration set at 1.0%), where feasible), (b)(concentration set at where feasible), (a)(6)(v), (vi),
(f), (g)(1)(i), (iii), (iv), (vi), (ix), 1.0%), and (c). (particulate), and (c).
(sensitization), (irritation to the eyes, (ii) Hazard communication. (ii) Hazard communication.
lungs, and mucous membranes), Requirements as specified in § 721.72(a) Requirements as specified in § 721.72(a)
(g)(2)(i), (ii), (iii), (iv), (v), (g)(3)(i), (ii), through (e)(concentration set at 1%), (f), through (d), (f), (g)(1)(acute toxicity,
(g)(4)(i), (water release restriction (g)(1)(iv), (vii), (eye irritation), (g)(2)(i), mutagenicity, eye irritation), (g)(2)(i),
apply), and (g)(5). Alternative hazard (ii), (iii), (g)(3)(i), (ii), (g)(4)(i), (water (ii), (v), and (g)(5). Alternative hazard
and warning statements that meet the release restriction apply), and (g)(5). and warning statements that meet the
criteria of the Globally Harmonized Alternative hazard and warning criteria of the Globally Harmonized
System and OSHA Hazard statements that meet the criteria of the System and OSHA Hazard
Communication Standard may be used. Globally Harmonized System and OSHA Communication Standard may be used.
(iii) Industrial, commercial, and Hazard Communication Standard may (iii) Industrial, commercial, and
consumer activities. Requirements as be used. consumer activities. Requirements as
specified in § 721.80(f), (g), (w)(3) and (iii) Industrial, commercial, and specified in § 721.80(f). It is a significant
(4). It is a significant new use to consumer activities. Requirements as new use to import, process, or use the
manufacture, process, or use of the PMN specified in § 721.80(f), (g), (w)(3), and PMN substance at a concentration
substance with greater than 0.1% of the (w)(4). It is a significant new use to greater than 0.4%.
manufacture, process, or use of the PMN (b) Specific requirements. The
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particle size distribution less than 10
microns. substance with greater than 0.1% of the provisions of subpart A of this part
(iv) Disposal requirements. particle size distribution less than 10 apply to this section except as modified
Requirements as specified in microns. by this paragraph (b).
§ 721.85(a)(1), (b)(1), and (c)(1). (iv) Disposal. Requirements as (1) Recordkeeping. Recordkeeping
(v) Release to water. Requirements as specified in § 721.85(a)(1), (b)(1), and requirements as specified in
specified in § 721.90(a)(2)(iv), (b)(2)(iv), (c)(1). § 721.125(a) through (i) are applicable to
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![Federal Register / Vol. 83, No. 192 / Wednesday, October 3, 2018 / Rules and Regulations 49825
manufacturers and processors of this apply to this section except as modified (2) Limitations or revocation of
substance. by this paragraph (b). certain notification requirements. The
(2) Limitations or revocation of (1) Recordkeeping. Recordkeeping provisions of § 721.185 apply to this
certain notification requirements. The requirements as specified in section.
provisions of § 721.185 apply to this § 721.125(a) through (i) are applicable to (3) Determining whether a specific use
section. manufacturers, importers, and is subject to this section. The provisions
■ 21. Add § 721.11167 to subpart E to
processors of this substance. of § 721.1725(b)(1) apply to paragraph
read as follows: (2) Limitations or revocation of (a)(2)(iii) of this section.
certain notification requirements. The ■ 23. Add § 721.11169 to subpart E to
§ 721.11167 Siloxanes and Silicones, di- provisions of § 721.185 apply to this read as follows:
Me, hydrogen-terminated, reaction products section.
with acrylic acid and 2-ethyl-2-[(2-propen-1- § 721.11169 2-Pentanone, 2,2′,2″- [O,O′,O″-
■ 22. Add § 721.11168 to subpart E to
yloxyl)methyl]-1,3-propanediol, polymers (methylsilylidyne)trioxime].
with chlorotrimethylsilane-iso-Pr alc.- read as follows:
(a) Chemical substance and
sodium reaction products.
§ 721.11168 2-Pentanone, 2,2′,2″-[O,O′,O″- significant new uses subject to reporting.
(a) Chemical substance and (ethenylsilylidyne)trioxime]. (1) The chemical substance 2-
significant new uses subject to reporting. (a) Chemical substance and pentanone, 2,2′,2″- [O,O′,O″-
(1) The chemical substance identified as significant new uses subject to reporting. (methylsilylidyne)trioxime] (PMN P–
siloxanes and silicones, di-Me, (1) The chemical substance 2- 17–309, CAS No. 37859–55–5) is subject
hydrogen-terminated, reaction products pentanone, 2,2′,2″-[O,O′,O″- to reporting under this section for the
with acrylic acid and 2-ethyl-2-[(2- (ethenylsilylidyne)trioxime] (PMN P– significant new uses described in
propen-1-yloxyl)methyl]-1,3- 17–308, CAS No. 58190–62–8) is subject paragraph (a)(2) of this section. The
propanediol, polymers with to reporting under this section for the requirements of this section do not
chlorotrimethylsilane-iso-Pr alc.-sodium significant new uses described in apply to quantities of the substance after
reaction products (P–17–296, CAS No. paragraph (a)(2) of this section. The they have been completely reacted
2014386–23–1) is subject to reporting requirements of this section do not (cured).
under this section for the significant apply to quantities of the substance after (2) The significant new uses are:
new uses described in paragraph (a)(2) they have been completely reacted (i) Protection in the workplace.
of this section. The requirements of this (cured). Requirements as specified in
section do not apply to quantities of the (2) The significant new uses are: § 721.63(a)(1), (a)(2)(i), (a)(3), (when
PMN substance after they have been (i) Protection in the workplace. determining which persons are
completely reacted (cured). Requirements as specified in reasonably likely to be exposed as
(2) The significant new uses are: § 721.63(a)(1), (a)(2)(i), (a)(3), (when required for § 721.63(a)(1), engineering
(i) Protection in the workplace. determining which persons are control measures (e.g., enclosure or
Requirements as specified in reasonably likely to be exposed as confinement of the operation, general
§ 721.63(a)(1), (a)(2)(i), (ii), (iii), (a)(3), required for § 721.63(a)(1), engineering and local ventilation) or administrative
(a)(4), (a)(5), (respirators must provide a control measures (e.g., enclosure or control measures (e.g., workplace
National Institute for Occupational confinement of the operation, general policies and procedures) shall be
Safety and Health assigned protection and local ventilation) or administrative considered and implemented to prevent
factor of at least 1,000 and are required control measures (e.g., workplace exposure, where feasible),
for any process generating a spray, mist, policies and procedures) shall be (b)(concentration set at 1%), and (c).
or aerosol), (when determining which considered and implemented to prevent (ii) Hazard communication.
persons are reasonable likely to be exposure, where feasible), Requirements as specified in § 721.72(a)
exposed as required for § 721.63(a)(1), (b)(concentration set at 1.0%), and (c). through (e)(concentration set at 1%), (f),
engineering control measures (e.g., (ii) Hazard communication. (g)(1)(i), (iii), (iv), (vi), (vii), (viii), (ix),
enclosure or confinement of the Requirements as specified in § 721.72(a) (g)(2)(i), (iii), (v), and (g)(5). Alternative
operation, general and local ventilation) through (e)(concentration set at 1.0%), hazard and warning statements that
or administrative control measures (e.g., (f), (g)(1)(i), (iii), (iv), (vi), (vii), (viii), meet the criteria of the Globally
workplace policies and procedures) (ix), (g)(2)(i), (iii), (v), and (g)(5). Harmonized System, and OSHA Hazard
shall be considered and implemented to Alternative hazard and warning Communication Standard may be used.
prevent exposures, where feasible), statements that meet the criteria of the (iii) Industrial, commercial, and
(a)(6)(v), (vi), (particulate), Globally Harmonized System, and consumer activities. Requirements as
(b)(concentration set at 1%), and (c). OSHA Hazard Communication Standard specified in § 721.80(f) and (q). It is a
(ii) Hazard communication. may be used. significant new use to process or use the
Requirements as specified in § 721.72(a) (iii) Industrial, commercial, and substance involving a method that
through (e)(concentration set at 1%), (f), consumer activities. Requirements as generates a vapor, mist, or aerosol.
(g)(1)(i), (sensitization) (iv), (vii), (ix), specified in § 721.80(f) and (q). It is a (b) Specific requirements. The
(g)(2)(i), (ii), (iii), (iv), (v), and (g)(5). significant new use to process or use the provisions of subpart A of this part
Alternative hazard and warning substance involving a method that apply to this section except as modified
statements that meet the criteria of the generates a vapor, mist, or aerosol. by this paragraph (b).
Globally Harmonized System and OSHA (b) Specific requirements. The (1) Recordkeeping. Recordkeeping as
Hazard Communication Standard may provisions of subpart A of this part specified in § 721.125(a) through (i) are
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be used. apply to this section except as modified applicable to manufacturers and
(iii) Industrial, commercial, and by this paragraph (b). processors of this substance.
consumer activities. Requirements as (1) Recordkeeping. Recordkeeping as (2) Limitations or revocation of
specified in § 721.80(f). specified in § 721.125(a) through (i) are certain notification requirements. The
(b) Specific requirements. The applicable to manufacturers and provisions of § 721.185 apply to this
provisions of subpart A of this part processors of this substance. section.
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![49826 Federal Register / Vol. 83, No. 192 / Wednesday, October 3, 2018 / Rules and Regulations
(3) Determining whether a specific use ■ 25. Add § 721.11171 to subpart E to operation, general and local ventilation)
is subject to this section. The provisions read as follows: or administrative control measures (e.g.,
of § 721.1725(b)(1) apply to paragraph workplace policies and procedures)
(a)(2)(iii) of this section. § 721.11171 Polymer of aliphatic shall be considered and implemented to
dicarboxylic acid and dicyclo alkane amine
■ 24. Add § 721.11170 to subpart E to (generic).
prevent exposures, where feasible), and
read as follows: (c).
(a) Chemical substance and (ii) Hazard communication.
§ 721.11170 Naphthalene trisulfonic acid significant new uses subject to reporting. Requirements as specified in § 721.72(a)
sodium salt (generic). (1) The chemical substance identified through (d), (f), (g)(1)(i), (eye and
(a) Chemical substance and generically as polymer of aliphatic respiratory irritation), (g)(2)(i), (ii), (iii),
significant new uses subject to reporting. dicarboxylic acid and dicyclo alkane (v), and (g)(5). Alternative hazard and
(1) The chemical substance identified amine (P–17–327) is subject to reporting warning statements that meet the
generically as naphthalene trisulfonic under this section for the significant criteria of the Globally Harmonized
acid sodium salt (P–17–321) is subject new uses described in paragraph (a)(2) System and OSHA Hazard
to reporting under this section for the of this section. The requirements of this Communication Standard may be used.
significant new uses described in section do not apply to quantities of the (iii) Industrial, commercial, and
paragraph (a)(2) of this section. substance after they have been reacted consumer activities. Requirements as
(2) The significant new uses are: (cured). specified in § 721.80. It is a significant
(i) Protection in the workplace. (2) The significant new uses are: new use to manufacture, process, or use
Requirements as specified in (i) Industrial, commercial, and the substance for consumer use or for
§ 721.63(a)(1), (a)(2)(i), (iv), (a)(3), (a)(4), consumer activities. Requirements as commercial uses that could introduce
(a)(5)(respirators must provide a specified in § 721.80. It is a significant the substance into a consumer setting. It
National Institute for Occupational new use to manufacture (includes is a significant new use to manufacture,
Safety and Health assigned protection import) the substance to have an average process, or use the substance in any
factor of at least 50), (when determining molecular weight of greater than 10,000 manner that generates a dust, mist, or
which persons are reasonable likely to Daltons. aerosol.
be exposed as required for (ii) [Reserved] (b) Specific requirements. The
§ 721.63(a)(1), engineering control (b) Specific requirements. The provisions of subpart A of this part
measures (e.g., enclosure or provisions of subpart A of this part apply to this section except as modified
confinement of the operation, general apply to this section except as modified by this paragraph (b).
and local ventilation) or administrative by this paragraph (b). (1) Recordkeeping. Recordkeeping
control measures (e.g., workplace (1) Recordkeeping. Recordkeeping requirements as specified in
policies and procedures) shall be requirements as specified in § 721.125(a) through (i) are applicable to
considered and implemented to prevent § 721.125(a) through (c) and (i) are manufacturers, importers, and
exposures, where feasible), applicable to manufacturers, importers, processors of this substance.
(b)(concentration set at 1.0%), and (c). and processors of this substance. (2) Limitations or revocation of
(ii) Hazard communication. (2) Limitations or revocation of certain notification requirements. The
Requirements as specified in § 721.72(a) certain notification requirements. The provisions of § 721.185 apply to this
through (e)(concentration set at 1.0%), provisions of § 721.185 apply to this section.
(f), (g)(1)(i), (ii), (iv), (ix), (g)(2)(i), (ii), section. [FR Doc. 2018–21194 Filed 10–2–18; 8:45 am]
(iii), (iv), (v), and (g)(5). Alternative ■ 26. Add § 721.11172 to subpart E to BILLING CODE 6560–50–P
hazard and warning statements that read as follows:
meet the criteria of the Globally
Harmonized System and OSHA Hazard § 721.11172 Hexanedioic acid, polymer
with trifunctional polyol, 1,1′-methylenebis ENVIRONMENTAL PROTECTION
Communication Standard may be used. AGENCY
(iii) Industrial, commercial, and [isocyanatobenzene], and 2,2′-oxybis
[ethanol] (generic).
consumer activities. Requirements as 40 CFR Part 52
specified in § 721.80(q) and (t). It is a (a) Chemical substance and
significant new use to manufacture, significant new uses subject to reporting. [EPA–R07–OAR–2017–0512; FRL–9984–
(1) The chemical substance identified 66—Region 7]
process, or use the substance in any
manner that generates a vapor, mist, or generically as hexanedioic acid,
polymer with trifunctional polyol, 1,1′- Approval of Kansas Air Quality State
aerosol. Implementation Plans; Construction
(b) Specific requirements. The methylenebis [isocyanatobenzene], and
2,2′-oxybis [ethanol] (P–17–330) is Permits and Approvals Program
provisions of subpart A of this part
apply to this section except as modified subject to reporting under this section AGENCY: Environmental Protection
by this paragraph (b). for the significant new uses described in Agency (EPA).
(1) Recordkeeping. Recordkeeping paragraph (a)(2) of this section. The ACTION: Final rule.
requirements as specified in requirements of this section do not
§ 721.125(a) through (i) are applicable to apply to quantities of the substance after SUMMARY: The Environmental Protection
manufacturers, importers, and they have been reacted (cured). Agency (EPA) is taking final action to
processors of this substance. (2) The significant new uses are: approve revisions to the Kansas State
(2) Limitations or revocation of (i) Protection in the workplace. Implementation Plan (SIP) and the
Requirements as specified in Clean Air Act (CAA) 112(l) program.
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certain notification requirements. The
provisions of § 721.185 apply to this § 721.63(a)(1), (a)(2)(i), (ii), (iii), (iv), Specifically, these revisions implement
section. (a)(3), (when determining which the revised National Ambient Air
(3) Determining whether a specific use persons are reasonable likely to be Quality Standards (NAAQS) for fine
is subject to this section. The provisions exposed as required for § 721.63(a)(1), particulate matter; clarify and refine
of § 721.1725(b)(1) apply to paragraph engineering control measures (e.g., applicable criteria for sources subject to
(a)(2)(iii) of this section. enclosure or confinement of the the Kansas minor New Source Review
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Document Created: 2018-10-03 02:29:48
Document Modified: 2018-10-03 02:29:48
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Direct final rule. | |
| Dates | This rule is effective on December 3, 2018. For purposes of judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on October 17, 2018. | |
| Contact | For technical information contact: Kenneth Moss, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: | |
| FR Citation | 83 FR 49806 | |
| RIN Number | 2070-AB27 | |
| CFR Citation | 40
CFR
721 40 CFR 9 | |
| CFR Associated | Chemicals; Hazardous Substances; Environmental Protection and Reporting and Recordkeeping Requirements |
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