83 FR 43538 - Significant New Use Rules on Certain Chemical Substances
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 83, Issue 166 (August 27, 2018)
Federal Register Volume 83, Issue 166 (August 27, 2018)
| Page Range | 43538-43556 | |
| FR Document | 2018-18403 |
[Federal Register Volume 83, Number 166 (Monday, August 27, 2018)] [Rules and Regulations] [Pages 43538-43556] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-18403] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 9 and 721 [EPA-HQ-OPPT-2017-0464; FRL-9982-24] 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 19 chemical substances which were the subject of premanufacture notices (PMNs). The chemical substances are subject to Orders issued by EPA pursuant to section 5(e) of TSCA. This action requires persons who intend to manufacture (defined by statute to include import) or process any of these 19 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 October 26, 2018. For purposes of judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on September 10, 2018. Written adverse comments on one or more of these SNURs must be received on or before September 26, 2018 (see Unit VI. of the SUPPLEMENTARY INFORMATION). If EPA receives written adverse comments on one or more of these SNURs before September 26, 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-2017-0464, 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 September 26, 2018 are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see Sec. [emsp14]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 [[Page 43539]] 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 September 26, 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. 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. [emsp14]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 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 19 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) 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 [[Page 43540]] 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 specify 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 19 PMN substances that are subject to Orders under TSCA section 5(e)(1)(A)(ii)(I) where EPA determined that it has insufficient information to conduct a reasoned evaluation and the activities associated with the PMN substances may present unreasonable risk to human health or the 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 may present an unreasonable risk of injury to human health via inhalation exposure, the underlying TSCA section 5(e) Order usually requires, 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. [emsp14]721.30. EPA expects that persons whose Sec. 721.30 requests to use 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-15-719 Chemical name: Benzene, 1,4-bis(alkyl)-, homopolymer (generic). CAS number: Not available. Effective date of TSCA section 5(e) Order: July 24, 2017. Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the substance will be as a flame retardant synergist and radical source. Based on test data and analog data EPA estimates that the PMN substances will persist in the environment for more than two months and estimates a bioaccumulation factor of greater than or equal to 1,000. Because the PMN substance is expected to be persistent and bioaccumulative, EPA is unable to assess the potential risks to sediment dwelling organisms. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), as well as 5(a)(3)(B)(i) and 5(e)(1)(A)(i) based on findings that the substance may present an unreasonable risk of injury to health and the environment, and that the information available to the Agency is insufficient to permit a reasoned evaluation of the environmental effects of the PMN substance. To protect against potential risks, the Order requires: 1. Submit to EPA certain toxicity testing prior to exceeding the confidential production volume limits specified in the Order; 2. Label containers of the substance and provide Safety Data Sheets (SDS) or Material Safety Data Sheets (MSDS) and worker training in accordance with the provisions of the Hazard Communication Program section; 3. Not use the substance other than for the confidential uses allowed in the Order; 4. Dispose of the substance only by incineration or landfill; and 5. Comply with the release to water provisions. 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 fate, bioaccumulation, and environmental toxicity 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 confidential production limit without performing specific aquatic toxicity, bioaccumulation and environmental fate testing. CFR citation: 40 CFR 721.11097. PMN Number P-16-99 Chemical name: Polyethylene glycol polymer with aliphatic polycarbodiimide Bis(alkoxysilylpropyl) amine blocked (generic). CAS number: Not available. Effective date of TSCA section 5(e) Order: June 30, 2017. Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the substance will be as an additive for industrial coatings. EPA identified concerns for irritation to all issues and lung toxicity based on SAR analysis of test data on analogous alkoxysilanes and concerns for acute toxicity, neurotoxicity (especially to the eye), and liver, kidney, and cardiac toxicity based on the release of methanol. 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 the substance may present an unreasonable risk of injury to health and the environment. To protect against potential risks, the Order requires: 1. Submission to EPA of certain toxicity testing prior to exceeding the confidential aggregate production volume limit specified in the Order; 2. Use of personal protective equipment to prevent dermal exposure (where there is a potential for dermal exposure); 3. Use of a National Institute for Occupational Safety and Health (NIOSH)-certified respirator with an Applied Protection Factor (APF) of at least 10 (where there is a potential for inhalation exposure) or compliance with a New Chemicals Exposure Limit (NCEL) of 0.9 milligrams per cubic meter as an 8-hour time-weighted average to prevent inhalation exposure. (EPA's estimates indicate that variations of the parameters (including batch size, number of processing sites, days per year of operation) of the uses identified below would not result in inhalation exposure that would indicate a different respirator.) 4. Establishment and use of a hazard communication program, including precautionary statements on each label and in the SDS. 5. Not use the substance other than for the use allowed in the Order in commercial use (as that term is defined in 40 CFR 721.3) but without any use in [[Page 43541]] a consumer setting (as that term is defined in 40 CFR 721.3); 6. Not exceed the confidential annual production volume limit in the Order; and 7. No manufacture of the substance where there is more than 0.2% residual isocyanate. 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 toxicity 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. The submitter has agreed not to exceed the confidential production limit without performing specific pulmonary and internal organ toxicity testing. CFR citation: 40 CFR 721.11098. PMN Number P-16-221 Chemical name: Fluorinated organopolysilazane (generic). CAS number: Not available. Effective date of TSCA section 5(e) Order: June 20, 2017. Basis for TSCA section 5(e) Order: The PMN states that the substance will be used as a coating agent for optical lenses. EPA identified human health and environmental concerns because the potential degradation products of the PMN substance may be persistent, bioaccumulative, and toxic (PBT) chemicals. EPA estimates that the PMN substance degradation products will persist in the environment for more than two months and estimates a bioaccumulation factor of greater than or equal to 1,000. EPA also identified concerns for liver toxicity, blood toxicity, male reproductive toxicity, and toxicity to aquatic organisms, terrestrial mammals and birds based on data for the PMN substance degradation product. 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 the substance may present an unreasonable risk of injury to health and the environment. To protect against potential risks, the Order requires: 1. Submission to EPA of certain toxicity testing before exceeding a total production volume of 204 kilograms, as specified in the Order; 2. Use of personal protective equipment to prevent dermal exposure (where there is a potential for dermal exposures); 3. No use of the substance other than allowed by the Order which is the confidential coating system described in the PMN; 4. Manufacture not to exceed an annual manufacture volume of 100 kilograms; 5. Refrain from domestic manufacture in the United States (i.e., import only); and 6. No release of the PMN substance to surface waters. 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 toxicity 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. The submitter has agreed not to exceed the production limit in the Order without performing specific internal organ toxicity testing on the degradation product of the PMN substance. In addition, EPA has determined that the results of specific organ toxicity on degradations products of the PMN substance may be potentially useful in characterizing the health effects of the PMN substance. Although the Order does not require this additional testing, the Order's restrictions on manufacture, processing, distribution in commerce, use, and disposal will remain in effect until the Order is modified or revoked by EPA based on submission of this or other information that EPA determines is relevant and needed to evaluate a modification request. CFR citation: 40 CFR 721.11099. PMN Number P-16-359 Chemical name: Carbopolycycle-bis(diazonium), dihalo-, chloride (1:2), reaction products with metal hydroxide, 4- [(dioxoalkyl)amino]substituted benzene, 2- [(dioxoalkyl)amino]substituted benzene, 5-[(dioxoalkyl)amino]-2- hydroxy-substituted benzene and oxo-n-phenylalkanamide (generic). CAS number: Not available. Effective date of TSCA section 5(e) Order: June 20, 2017. Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the substance will be as a pigment additive for industrial coatings. EPA identified concerns for oncogenicity and mutagenicity for the PMN substance degradation product. 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 the substance may present an unreasonable risk of injury to health and the environment. To protect against potential risks, the Order requires: 1. Submission to EPA of certain toxicity testing before exceeding the confidential production volume limit specified in the Order; 2. Use of personal protective equipment to prevent dermal exposure (where there is a potential for inhalation exposures); 3. Establishment and use of a hazard communication program, including precautionary statements on each label and in SDS; 4. No processing or use of the substance at temperatures greater than 200 degrees Celsius; and 5. No domestic manufacture of the substance. 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 and biodegradability 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. The submitter has agreed not to exceed the production limit in the Order without performing specific biodegradability and photolysis tests. CFR citation: 40 CFR 721.11100. PMN Number P-16-363 Chemical name: Blocked polyester polyurethane, neutralized (generic). CAS number: Not available. Effective date of TSCA section 5(e) Order: June 20, 2017. Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the substance will be an open non-dispersive use. EPA identified concerns for irritation, sensitization, and lung toxicity based on analogy to diisocyanates and cationic binding to lung tissue. 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 the substance may present an unreasonable risk of injury to human health. To protect against potential risks, the Order requires: 1. Use personal protective equipment to prevent dermal exposure (where there is a potential for dermal exposures); 2. Establishment and use of a hazard communication program, including [[Page 43542]] precautionary statements on each label and in the SDS; 3. Manufacture (including import) the substance with a residual of free isocyanate monomers no greater than 0.1% by weight; 4. Refraining from manufacture, processing, or use activities if it results in inhalation exposure to vapor, dust, mist or aerosols; 5. Refraining from manufacture, processing, or use for consumer use or in commercial use (as that term is defined in 40 CFR 721.3) where there is use in a consumer setting (as that term is defined in 40 CFR 721.3); and 6. Manufacture, process, or use the substance only in an aqueous formulation. 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 toxicity 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. EPA has determined that the results of specific target organ toxicity testing and a sensitization test of the PMN substance may be potentially useful in characterizing the health effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions on manufacture, processing, use, distribution in commerce, and disposal will remain in effect until the Order is modified or revoked by EPA based on submission of this or other information that EPA determines is relevant and needed to evaluate a modification request. CFR citation: 40 CFR 721.11101. PMN Number P-16-370 Chemical name: Methoxy-terminated polysiloxane (generic). CAS number: Not available. Effective date of TSCA section 5(e) Order: July 18, 2017. Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the substance will be as a crosslinker for adhesives and coatings. EPA identified concerns for irritation to the skin, eyes, lung, and mucous membranes and other lung effects on analogy to alkoxysilanes. 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 the substance may present an unreasonable risk of injury to human health. To protect against potential risks, the Order requires: 1. Submission to EPA of certain toxicity testing before exceeding the confidential production volume limit specified in the Order; 2. Use of personal protective equipment to prevent dermal exposure (where there is a potential for dermal exposures); 3. Establishment and use of a hazard communication program, including precautionary statements on each label and in the SDS; 4. Use of a NIOSH-certified respirator with an APF of at least 10 (where there is a potential for inhalation exposures) or compliance with a NCEL of 8.4 milligrams per cubic meter as an 8-hour time- weighted average to prevent inhalation exposure. (EPA's estimates indicate that variations of the parameters (including batch size, number of processing sites, days per year of operation) of the uses identified below would not result in inhalation exposure that would indicate a different respirator.) 5. Refraining from modifying the manufacture, processing, or use activities if it results in inhalation exposure to vapor, dust, mist or aerosols; and 6. Refraining from manufacture, processing, or use for consumer use or in commercial use (as that term is defined in 40 CFR 721.3) where there is use in a consumer setting (as that term is defined in 40 CFR 721.3). 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 toxicity 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. The submitter has agreed not to exceed the production limit in the Order without performing specific pulmonary toxicity testing. CFR citation: 40 CFR 721.11103. PMN Number P-16-376 Chemical name: Hydroxystyrene resin (generic). CAS number: Not available. Effective date of TSCA section 5(e) Order: June 16, 2017. Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the substance will be for photolithography. EPA identified potential health and environmental toxicity if the PMN substance is manufactured at a lower molecular weight. 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 the substance may present an unreasonable risk of injury to health and the environment. To protect against potential risks, the Order requires manufacture of the substance at an average molecular weight greater than 2906 daltons and with 0.5 percent low weight molecular species less than 500 daltons and 1.0 percent low weight molecular species less than 1,000 daltons. 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 toxicity of the PMN substance may be potentially useful to characterize the health and environmental 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 physical-chemical property tests, internal organ effects testing, and aquatic toxicity tests may be potentially useful in characterizing the health and environmental effects of the PMN substance. Although the Order does not require this testing, the Order's restrictions on manufacture, processing, distribution in commerce, use, and disposal will remain in effect until the Order is modified or revoked by EPA based on submission of this or other information that EPA determines is relevant and needed to evaluate a modification request CFR citation: 40 CFR 721.11104. PMN Number P-16-487 Chemical name: Benzenesulfonic acid 1,2-diazenediylbis[6-ethenyl]- 3-sulfophenyl diazenyl-2-sulfophenyl ethenyl salt (generic). CAS number: Not available. Effective date of TSCA section 5(e) Order: June 27, 2017. Basis for TSCA section 5(e) Order: The PMN states that the substance will be used as a yellow dye for paper. EPA identified concerns for developmental, reproductive, liver, kidney, and blood toxicity based for the azo reduction products of the substance based on analogue data. Based on SAR analysis for acid dyes, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 55 parts per billion (ppb) in surface waters. The [[Page 43543]] Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), as well as 5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II), based on a finding that the substance may present an unreasonable risk of injury to health and the environment and that the substance is or will be produced in substantial quantities and there is or may be significant (substantial) human exposure to the substance. To protect against potential risks, the Order requires: 1. Submission to EPA of certain toxicity testing before exceeding the confidential production volume limits specified in the Order; 2. Use of personal protective equipment to prevent dermal exposure (where there is a potential for dermal exposures); 3. Establishment and use of a hazard communication program, including precautionary statements on each label and in the SDS; 4. No manufacture of the substance in the United States (i.e. import only); 5. Import the substance only as a solution; 6. No use of the substance other than for the confidential uses allowed in the Order; and 7. Not release the substance in surface waters resulting in concentrations that exceed 55 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 fate and toxicity of the PMN substance may be potentially useful to characterize the health and environmental 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 production limit in the Order without performing specific photolysis, internal organ effects, reproductive/developmental toxicity, and aquatic toxicity tests. CFR citation: 40 CFR 721.11105. PMN Number P-16-533 Chemical name: Ethanaminium, alkyl-, salt with triazole (generic). CAS number: Not available. Effective date of TSCA section 5(e) Order: July 24, 2017. Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the substance will be as a cleaning agent for electronics manufacture. EPA identified concerns for neurotoxicity, developmental and reproductive toxicity, irritation, corrosion, sensitization, and carcinogenicity based on analogy to benzotriazole and quaternary amines. Based on SAR analysis of test data on analogous benzotriazoles, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 570 ppb in surface waters. 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 the substance may present an unreasonable risk of injury to health and the environment. To protect against potential risks, the Order requires: 1. Submission to EPA of certain toxicity testing before exceeding the confidential production volume limits specified in the Order; 2. Use of personal protective equipment to prevent dermal exposure (where there is a potential for dermal exposure); 3. Establishment and use of a hazard communication program, including precautionary statements on each label and in the SDS; 4. Refrain from manufacture, process or use activities that result in inhalation exposure to vapor, dust, mist or aerosols; 5. No use other than confidential use allowed by the Order; and 6. No release of the substance to surface waters. 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 toxicity of the PMN substance may be potentially useful to characterize the health and environmental 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 production limit in the Order without performing specific internal organ effects testing of the PMN substance. In addition, EPA has determined that the results of acute and chronic aquatic toxicity testing may be potentially useful in characterizing the environmental effects of the PMN substance. Although the Order does not require this additional testing, the Order's restrictions on manufacture, processing, distribution in commerce, use, and disposal will remain in effect until the Order is modified or revoked by EPA based on submission of this or other information that EPA determines is relevant and needed to evaluate a modification request. CFR citation: 40 CFR 721.11105. PMN Number P-16-595 Chemical name: Substituted-(hydroxyalkyl)-alkyl-alkanoic acid, hydroxy-(substitutedalkyl)-alkyl-, polymer with alpha-hydro-omega- hydroxypoly[oxy (alkylethanediyl)] and isocyanato-(isocyanatoalkyl)- multialkylcycloalkane, salt, alkanol-blocked, compds. (generic). CAS number: Not available. Effective date of TSCA section 5(e) Order: June 27, 2017. Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the substance will be as a polymer. EPA identified concerns for irritation to skin, eyes, and lung, kidney and developmental effects based on functional groups present as part of the PMN structure. Based on SAR analysis of test data on analogous polyanionic polymers, EPA identified potential environmental toxicity if the substance is produced with a different average molecular weight or proportion of repeating units. 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 the substance may present an unreasonable risk of injury to health and the environment. To protect against potential risks, the Order requires: 1. No manufacture of the substance in the United States (i.e. import only); 2. Import of the substance under the confidential conditions required by the Order; 3. No use of the substance other than as the confidential use allowed described in the Order; and 4. No release of the substance to surface waters. 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 physical-chemical properties and toxicity of the PMN substance may be potentially useful to characterize the health and environmental 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 physical-chemical property measurements, acute toxicity tests, and acute and chronic aquatic toxicity tests may be potentially useful in characterizing the health and environmental effects of the PMN substance. Although the Order does not require this additional testing, the Order's restrictions on manufacture, processing, distribution in commerce, use, and disposal will remain in effect [[Page 43544]] until the Order is modified or revoked by EPA based on submission of this or other information that EPA determines is relevant and needed to evaluate a modification request. CFR citation: 40 CFR 721.11106. PMN Number P-17-170 Chemical name: Alkanediol, 2,2-bis (substituted alkyl)- polymer with substituted alkane, heteromonocycles, alkenoate (generic). CAS number: Not available. Effective date of TSCA section 5(e) Order: July 12, 2017. Basis for TSCA section 5(e) Order: The PMN states that the substance will be used as an ultraviolet curable coating resin for three-dimensional printing applications. EPA identified concerns for oncogenicity, developmental toxicity, liver and kidney effects, sensitization, and irritation based on analogy to acrylates. EPA also identified additional human health concerns and environmental toxicity concerns if the polymer is made differently than described in the PMN. 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 the substance may present an unreasonable risk of injury to health and the environment. To protect against potential risks, the Order requires: 1. Submission to EPA of certain toxicity testing before exceeding the aggregate production volume limit of 105,000 kilograms specified in the Order; 2. Use of personal protective equipment to prevent dermal exposure including gloves (where there is a potential for dermal exposures); 3. Establishment and use of a hazard communication program, including precautionary statements on each label and in the SDS; 4. Refrain from manufacture, process or use activities that result in inhalation exposure to vapor, dust, mist or aerosols; 5. No use other than as an ultraviolet curable coating resin for three-dimensional printing applications; 6. Manufacture of the substance with no greater than 0.1% residual isocyanate; and 7. Manufacture of the substance with an average molecular weight greater than 1,000 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 physical-chemical properties and toxicity of the PMN substance may be potentially useful to characterize the health and environmental 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 production limit in the Order without performing specific mutagenicity and sensitization testing of the PMN substance. In addition, EPA has determined that the results of physical-chemical property measurements, internal organ toxicity tests, and acute and chronic aquatic toxicity tests may be potentially useful in characterizing the environmental effects of the PMN substance. Although the Order does not require this additional testing, the Order's restrictions on manufacture, processing, distribution in commerce, use, and disposal will remain in effect until the Order is modified or revoked by EPA based on submission of this or other information that EPA determines is relevant and needed to evaluate a modification request. CFR citation: 40 CFR 721.11107. PMN Number P-17-172 Chemical name: Sulfurized alkylphenol, calcium salts (generic). CAS number: Not available. Effective date of TSCA section 5(e) Order: June 19, 2017. Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the substance will be as a lubricating oil additive. EPA identified concerns for lung toxicity based on submitted test data and data for analogous chemicals. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), as well as 5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II), based on a finding that the substance may present an unreasonable risk of injury to human health and the environment, and the substance is or will be produced in substantial quantities and there is or may be significant (substantial) human exposure to the substance. To protect against potential risks, the Order requires: 1. Refrain from manufacture, process or use activities that result in inhalation exposure to vapor, dust, mist or aerosols; and 2. No use other than the confidential use allowed by 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 toxicity 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. EPA has determined that the results of pulmonary effects testing may be potentially useful in characterizing the health effects of the PMN substance. Although the Order does not require this additional testing, the Order's restrictions on manufacture, processing, distribution in commerce, use, and disposal will remain in effect until the Order is modified or revoked by EPA based on submission of this or other information that EPA determines is relevant and needed to evaluate a modification request. CFR citation: 40 CFR 721.11108. PMN Number P-17-177 Chemical name: Monoheteropentacycloalkane-4-carboxylic acid, substituted cyclo-alkyl ester (generic). CAS number: Not available. Effective date of TSCA section 5(e) Order: July 28, 2017. Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the substance will be for microlithography for electronic device manufacturing. EPA identified human health and environmental concerns because the substance may be persistent, bioaccumulative, and toxic (PBT) chemicals. EPA estimates that the substance will persist in the environment for more than two months and estimates a bioaccumulation factor of greater than or equal to 1,000. EPA identified concerns for oncogenicity, developmental toxicity, liver and kidney effects, sensitization, and irritation based on data for analogous chemicals. Based on SAR estimates for esters and other analogous chemicals. EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 2 ppb in surface waters. 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 the substance may present an unreasonable risk of injury to health and the environment. To protect against potential risks, the Order requires: 1. Use of personal protective equipment to prevent dermal exposure (where there is a potential for dermal exposures); 2. Establishment and use of a hazard communication program, including precautionary statements on each label and in the SDS; [[Page 43545]] 3. No manufacture of the substance in the United States (i.e. import only); 4. No use other than the confidential use allowed by the Order; 5. No exceedance of the confidential annual production volume limit in the Order; and 6. No release of the substance to surface waters. 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 and toxicity of the PMN substance may be potentially useful to characterize the health and environmental 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 acute toxicity, mutagenicity, sensitization, internal organ toxicity, reproductive/ developmental toxicity, biodegradation, bioconcentration, and acute and chronic aquatic toxicity testing may be potentially useful in characterizing the health and environmental effects of the PMN substance. Although the Order does not require this additional testing, the Order's restrictions on manufacture, processing, distribution in commerce, use, and disposal will remain in effect until the Order is modified or revoked by EPA based on submission of this or other information that EPA determines is relevant and needed to evaluate a modification request. CFR citation: 40 CFR 721.11109. PMN Number P-17-179 Chemical name: Modified carboxypolyamine salt (generic). CAS number: Not available. Effective date of TSCA section 5(e) Order: July 31, 2017. Basis for TSCA section 5(e) Order: The PMN states that the substance will be used as a dispersive additive for pigments in industrial paints and coatings. EPA identified concerns for skin irritation and lung toxicity based on cationic binding properties. 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 the substance may present an unreasonable risk of injury to health and the environment. To protect against potential risks, the Order requires: 1. Submission to EPA of certain toxicity testing before excceding the confidential production volume limit specified in the Order; 2. Use of personal protective equipment to prevent dermal exposure (where there is a potential for dermal exposures); 3. Establishment and use of a hazard communication program, including precautionary statements on each label and in the SDS; 4. Refrain from manufacture, process or use activities that result in inhalation exposure to vapor, dust, mist or aerosols; 5. No use other than a dispersive additive for pigments in industrial paints and coatings; 6. No processing or use of the substance in a paint or coating formulation greater than 1% by weight or volume; and 7. No manufacture of the 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 toxicity 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. The submitter has agreed not to exceed the production limit in the Order without performing specific pulmonary effects testing of the PMN substance. CFR citation: 40 CFR 721.11110. PMN Number P-17-222 Chemical name: 1, 3,5-Triazine-2,4-diamine, 6-phenyl-, reaction products with polyalkylene glycol mono- alkyl ether and 2,4-toluene diisocyanate (generic). CAS number: Not available. Effective date of TSCA section 5(e) Order: July 28, 2017. Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the substance will be as an additive open non-dispersive use. EPA identified concerns for dermal sensitization, respiratory sensitization, lung effects, neurotoxicity, and developmental toxicity based on the potential for residual diisocyanates. 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 the substance may present an unreasonable risk of injury to health and the environment. To protect against potential risks, the Order requires: 1. Refrain from manufacture, process or use activities that result in inhalation exposure to vapor, dust, mist or aerosols; 2. Not sell the substance for ``consumer use'' or for ``commercial uses'' (as the term is defined at 40 CFR 721.3) when the ``saleable goods or service'' could introduce the material into a ``consumer'' setting (as that term is defined in 40 CFR 721.3); 3. Use the substance only in a formulation for the use allowed in the Order with isocyanate residuals not greater than 0.1 percent by weight or volume; and 4. Import the substance where there is no more than 0.15% residual toluene isocyanate. 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 toxicity 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. EPA has determined that the results of a sensitization test and pulmonary effects test may be potentially useful in characterizing the health effects of the PMN substance. Although the Order does not require this additional testing, the Order's restrictions on manufacture, processing, distribution in commerce, use, and disposal will remain in effect until the Order is modified or revoked by EPA based on submission of this or other information that EPA determines is relevant and needed to evaluate a modification request. CFR citation: 40 CFR 721.11111. PMN Number P-17-231 Chemical name: Fatty acids, polymers with benzoic acid, cyclohexanedicarboxylic acid anhydride, aliphatic diisocyanate, alkyl diol, alkyl triol, pentaerythritol, phthalic anhydride, polyalkylene glycol amine, and aromatic dicarboxylate sulfonic acid sodium salt (generic). CAS number: Not available. Effective date of TSCA section 5(e) Order: July 20, 2017. Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the substance will be as a paint, stain, or primer coating. EPA identified concerns for dermal sensitization, respiratory sensitization, lung effects, neurotoxicity, and developmental toxicity based on the potential for residual diisocyanates. The Order was issued under TSCA sections [[Page 43546]] 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that the substance may present an unreasonable risk of injury to health and the environment. To protect against potential risks, the Order requires: 1. Manufacture of the substance where there is no more than 0.1% residual isocyanate. 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 toxicity 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. EPA has determined that the results of a sensitization test and a pulmonary effects test may be potentially useful in characterizing the health effects of the PMN substance. Although the Order does not require this additional testing, the Order's restrictions on manufacture, processing, distribution in commerce, use, and disposal will remain in effect until the Order is modified or revoked by EPA based on submission of this or other information that EPA determines is relevant and needed to evaluate a modification request. CFR citation: 40 CFR 721.11112. PMN Numbers P-17-247 and P-17-248 Chemical names: Branched alkyl (C=17) carboxylic acid (generic) (P- 17-247) and branched alkyl (C=18) alcohol (generic) (P-17-248). CAS numbers: Not available. Effective date of TSCA section 5(e) Order: June 29, 2017. Basis for TSCA section 5(e) Order: The PMNs state that the generic (non-confidential) use of the substances will be as chemical raw materials. EPA identified human health and environmental concerns because the substances may be persistent, bioaccumulative, and toxic (PBT) chemicals. EPA estimates that the substances will persist in the environment for more than two months and estimates a bioaccumulation factor of greater than or equal to 1,000. Based on analogue data EPA identified concerns for developmental toxicity, liver, kidney, and thyroid effects, dermal sensitization, and irritation. Based on SAR estimates for neutral organic chemicals, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb in surface waters. 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 the substances may present an unreasonable risk of injury to health and the environment. To protect against potential risks, the Order requires: 1. Submission to EPA of certain toxicity testing before exceeding the confidential production volume limit specified in the Order; 2. Use of personal protective equipment to prevent dermal exposure (where there is a potential for dermal exposures); 3. Establishment and use of a hazard communication program, including precautionary statements on each label and in the SDS; 4. Refrain from manufacture, process or use activities that result in inhalation exposure to vapor, dust, mist or aerosols; 5. No use other than as a chemical intermediate; 6. No manufacture of the substances in the United States (i.e. import only); and 7. No release of the substances to surface waters. 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 bioaccumulation and toxicity of the PMN substance may be potentially useful to characterize the health and environmental 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 production limit in the Order without performing specific sensitization, internal organ effect, and reproductive/developmental testing of the PMN substances. In addition, EPA has determined that the results of acute aquatic toxicity and bioaccumulation testing may be potentially useful in characterizing the environmental and health effects of the PMN substances. Although the Order does not require this additional testing, the Order's restrictions on manufacture, processing, distribution in commerce, use, and disposal will remain in effect until the Order is modified or revoked by EPA based on submission of this or other information that EPA determines is relevant and needed to evaluate a modification request. CFR citations: 40 CFR 721.11113 P-17-247 and 40 CFR 721.11114 P-17- 248. PMN Number P-17-260 Chemical name: Alkoxy silane modified butadiene styrene copolymer (generic). CAS number: Not available. Effective date of TSCA section 5(e) Order: July 10, 2017. Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the substance will be as a resin modifier. EPA identified concerns for lung effects based on test data for the substance and data for analogous alkoxysilane non-ionic polymers. 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 the substance may present an unreasonable risk of injury to human health. To protect against potential risks, the Order requires: 1. Refrain from manufacture, process or use activities that result in inhalation exposure to vapor, dust, mist or aerosols; and 2. No use other than the confidential use allowed by 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 toxicity 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. EPA has determined that the results of pulmonary effects test may be potentially useful in characterizing the health effects of the PMN substance. Although the Order does not require this additional testing, the Order's restrictions on manufacture, processing, distribution in commerce, use, and disposal will remain in effect until the Order is modified or revoked by EPA based on submission of this or other information that EPA determines is relevant and needed to evaluate a modification request. CFR citation: 40 CFR 721.11115. 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 19 chemical substances, regulation was warranted under TSCA section 5(e), pending the development of information sufficient to make reasoned evaluations of the health or environmental effects of the chemical [[Page 43547]] substances. The basis for such findings is outlined in Unit IV. Based on these findings, TSCA section 5(e) Orders requiring the use of appropriate exposure controls were negotiated with the PMN submitters. 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, 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). 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 October 26, 2018 without further notice, unless EPA receives written adverse comments before September 26, 2018. If EPA receives written adverse comments on one or more of these SNURs before September 26, 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) Orders have been issued for all of the chemical substances, and the PMN submitters are prohibited by the TSCA section 5(e) Orders from undertaking activities which will be designated as significant new uses. The identities of the 19 chemical substances subject to these rules have been claimed as confidential and EPA has received no post-PMN bona fide submission (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 August 27, 2018 as the cutoff date for determining whether the new use is ongoing. The objective of EPA's approach has been to ensure that a person could not defeat a SNUR by initiating a significant new use before the effective date of the direct final rule. In developing this rule, EPA has recognized that, given EPA's practice of on occasion posting rules on its website a week or more in advance of Federal Register publication, this objective could be thwarted even before that publication. 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 potentially useful information for all of the listed SNURs. Descriptions of this information is 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). To access the OCSPP test guidelines referenced in this document electronically, please go to http://www.epa.gov/ocspp and select ``Test Methods and Guidelines.'' The Organisation for Economic Co-operation and Development (OECD) test guidelines are available from the OECD Bookshop at http://www.oecdbookshop.org or SourceOECD at http://www.sourceoecd.org. In certain of the TSCA section 5(e) Orders for the chemical substances regulated under this rule, EPA has established production volume limits in [[Page 43548]] 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 specified tests that would permit a reasoned evaluation of the potential risks posed by these chemical substances. Under recent TSCA section 5(e) Orders, each PMN submitter is required to submit each study at least 14 weeks (earlier TSCA section 5(e) Orders required submissions at least 12 weeks) before reaching the specified production limit. The SNURs contain the same production volume limits as the TSCA section 5(e) Orders. Exceeding these production limits is defined as a significant new use. Persons who intend to exceed the production 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. The 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 or other information 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 generate useful information. 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. [emsp14]721.1725(b)(1) with that under Sec. [emsp14]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. [emsp14]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 Sec. 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 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-2017-0464. 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) 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 [[Page 43549]] 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). 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: August 17, 2018. Jeffery T. Morris, Director, Chemical Control Division, 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. [emsp14]9.1, add the following sections in numerical order under the undesignated center heading ``Significant New Uses of Chemical Substances'' to read as follows: [[Page 43550]] Sec. [emsp14]9.1 OMB approvals under the Paperwork Reduction Act. * * * * * ------------------------------------------------------------------------ OMB control 40 CFR citation No. ------------------------------------------------------------------------ * * * * * ------------------------------------------------------------------------ Significant New Uses of Chemical Substances ------------------------------------------------------------------------ * * * * * 721.11097............................................... 2070-0012 721.11098............................................... 2070-0012 721.11099............................................... 2070-0012 721.11100............................................... 2070-0012 721.11101............................................... 2070-0012 721.11102............................................... 2070-0012 721.11103............................................... 2070-0012 721.11104............................................... 2070-0012 721.11105............................................... 2070-0012 721.11106............................................... 2070-0012 721.11107............................................... 2070-0012 721.11108............................................... 2070-0012 721.11109............................................... 2070-0012 721.11110............................................... 2070-0012 721.11111............................................... 2070-0012 721.11112............................................... 2070-0012 721.11113............................................... 2070-0012 721.11114............................................... 2070-0012 721.11115............................................... 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. [emsp14]721.11097 to subpart E to read as follows: Sec. [emsp14]721.11097 Benzene, 1,4-bis(alkyl)-, homopolymer (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically benzene, 1,4-bis(alkyl)-, homopolymer (PMN P-15-719) 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)(concentrations set at 1.0 percent), (f), (g)(4)(i), (iii), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System (GHS) and OSHA Hazard Communication Standard may be used. (ii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(k) and (q). (iii) Disposal. Requirements as specified in Sec. 721.85(a)(1), (2), (b)(1), (2), (c)(1), and (2). (iv) 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. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), and (f) 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. (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 5. Add Sec. [emsp14]721.11098 to subpart E to read as follows: Sec. [emsp14]721.11098 Polyethylene glycol polymer with aliphatic polycarbodiimide bis(alkoxysilylpropyl) amine blocked (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polyethylene glycol polymer with aliphatic polycarbodiimide bis(alkoxysilylpropyl) amine blocked (PMN P-16-99) 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), (a)(4), when determining which persons are reasonably likely to be exposed as required for Sec. 721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible, (a)(5) (respirators must provide a National Institute for Occupational Safety and Health (NIOSH) with an assigned protection factor (APF) of at least 10), (a)(6)(particulate), (b)(concentrations set at 1.0 percent) and (c). (A) As an alternative to the respirator requirements in paragraph (a)(2)(i) of this section, a manufacturer or processor may choose to follow the new chemical exposure limit (NCEL) provision listed in the TSCA section 5(e) Order for this substance. The NCEL is 0.9 mg/m\3\ as an 8-hour time weighted average. Persons who wish to pursue NCELs as an alternative to Sec. 721.63 respirator requirements may request to do so under Sec. 721.30. Persons whose Sec. 721.30 requests to use the NCELs approach are approved by EPA will be required to follow NCELs provisions comparable to those contained in the corresponding TSCA section 5(e) Order. (B) [Reserved] (ii) Hazard communication. Requirements as specified in Sec. 721.72(a) through (e)(concentration set 1.0 percent), (f), (g)(1)(ii), (g)(2)(ii), (iii), (use respiratory protection or maintain workplace airborne concentrations at or below an 8-hour time-weighted average of 0.9 mg/m3), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System (GHS) and OSHA Hazard Communication Standard may be used. (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(k), (q) and (t). It is a significant new use to process or use the chemical substance other than for commercial use but without any use in a consumer setting. It is a significant new use to manufacture the chemical substance containing greater than 0.2% residual isocyanate. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (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. (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. [emsp14]721.11099 to subpart E to read as follows: Sec. [emsp14]721.11099 Fluorinated organopolysilazane (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a fluorinated organopolysilazane (PMN P-16-221) 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), (a)(4), when determining which persons are reasonably likely to be exposed as required for Sec. 721.63(a)(1) engineering [[Page 43551]] 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)(6)(particulate), (a)(6)(v), (vi), (b)(concentrations set at 1.0 percent), and (c). (ii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(f), (p) (204 kilograms) and (s)(100 kilograms). It is a significant new use to use the substance other than in confidential coating system allowed in the Order. (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. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (e), (i), and (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. (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. [emsp14]721.11100 to subpart E to read as follows: Sec. [emsp14]721.11100 Carbopolycycle-bis(diazonium), dihalo-, chloride (1:2), reaction products with metal hydroxide, 4- [(dioxoalkyl)amino]substituted benzene, 2- [(dioxoalkyl)amino]substituted benzene, 5-[(dioxoalkyl)amino]-2- hydroxy-substituted benzene and oxo-n-phenylalkanamide (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as carbopolycycle-bis(diazonium), dihalo-, chloride (1:2), reaction products with metal hydroxide, 4-[(dioxoalkyl)amino] substituted benzene, 2-[(dioxoalkyl)amino]substituted benzene, 5-[(dioxoalkyl) amino] 2-hydroxy-substituted benzene and oxo-n-phenylalkanamide (PMN P- 16-359) 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), (a)(4), 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, (a)(6)(particulate), (b)(concentrations set at 0.1 percent) and (c). (ii) Hazard communication. Requirements as specified in Sec. 721.72(a) through (e)(concentration set 0.1 percent), (f), (g)(1)(iv), (vii), (g)(2)(i), (ii), (do not process or use at greater than 200 degrees Celsius), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System (GHS) 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 PMN substance at a temperature greater than 200 degrees C. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (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. (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 8. Add Sec. [emsp14]721.11101 to subpart E to read as follows: Sec. [emsp14]721.11101 Blocked polyester polyurethane, neutralized (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as blocked polyester polyurethane, neutralized (PMN P-16-363) 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), 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, (a)(2)(i), (ii), (iii), (a)(3), (a)(6)(particulate), (a)(6)(v), (vi) (b)(concentrations set at 0.1 percent) and (c). (ii) Hazard communication. Requirements as specified in Sec. 721.72 (a) through (e)(concentration set 0.1 percent), (f), (g)(1)(i), (ii), (g)(2)(i), (ii), (iii), (iv), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System (GHS) 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 with a residual of free isocyanate monomers greater than 0.1 percent by weight. It is a significant new use to modify manufacture, process or use activities if it results in inhalation exposure to vapor, dust, mist or aerosols to the substance. It is a significant new use to manufacture, process, or use the substance for consumer use, or for commercial uses when the saleable goods or service could introduce the substance into a consumer setting. It is a significant new use to manufacture, process, or use the substance other than in an aqueous formulation. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (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 9. Add Sec. [emsp14]721.11102 to subpart E to read as follows: Sec. [emsp14]721.11102 Methoxy-terminated polysiloxane (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as methoxy-terminated polysiloxane (PMN P-16-370) 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 [[Page 43552]] Sec. 721.63(a)(1), (a)(2)(i), (ii), (iii), (a)(3), (a)(4), when determining which persons are reasonably likely to be exposed as required for Sec. 721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible, (a)(5) (respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 25), (a)(6)(particulate), (a)(6)(v), (vi), (b)(concentrations set at 1.0 percent), and (c). (A) As an alternative to the respirator requirements in paragraph (a)(2)(i) of this section, a manufacturer or processor may choose to follow the new chemical exposure limit (NCEL) provision listed in the TSCA section 5(e) Order for this substance. The NCEL is 8.4 milligrams per cubic meter as an 8-hour time weighted average. Persons who wish to pursue NCELs as an alternative to Sec. 721.63 respirator requirements may request to do so under Sec. 721.30. Persons whose Sec. 721.30 requests to use the NCELs approach are approved by EPA will be required to follow NCELs provisions comparable to those contained in the corresponding TSCA section 5(e) Order. (B) [Reserved] (ii) Hazard communication. Requirements as specified in Sec. 721.72(a) through (e)(concentration set 1.0 percent), (f), (g)(1)(i), (ii), (g)(2)(i), (ii), (iii), (use respiratory protection or maintain workplace airborne concentrations at or below an 8-hour time-weighted average of 8.4 mg/m3), (g)(2)(v), (do not use for spray application), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System (GHS) and OSHA Hazard Communication Standard may be used. (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(q), and (y)(1). It is a significant new use to manufacture, process, or use the substance for consumer use, or for commercial uses when the saleable goods or service could introduce the substance into a consumer setting. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (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. (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 10. Add Sec. [emsp14]721.11103 to subpart E to read as follows: Sec. [emsp14]721.11103 Hydroxystyrene resin (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as hydroxystyrene resin (PMN P-16-376) 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 use to manufacture the PMN substance with an average molecular weight less than 2906 daltons and to have greater than 0.5 percent low weight molecular species less than 500 daltons and 1.0 percent low weight molecular species less than 1000 daltons. (ii) [Reserved] (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (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 11. Add Sec. [emsp14]721.11104 to subpart E to read as follows: Sec. [emsp14]721.11104 Benzenesulfonic acid 1,2-diazenediylbis[6- ethenyl]-3-sulfophenyl diazenyl-2-sulfophenyl ethenyl salt (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as benzenesulfonic acid 1,2-diazenediylbis[6-ethenyl]-3-sulfophenyl diazenyl-2-sulfophenyl ethenyl salt (PMN P-16-487) 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 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 1.0 percent), and (c). (ii) Hazard communication. Requirements as specified in Sec. 721.72(a) through (e)(concentration set 1.0 percent), (f), (g)(1)(iv), (vi), (ix), (blood effects), (g)(2)(i), (v), (g)(3)(i), (ii), (g)(4)(water release restrictions apply), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System (GHS) and OSHA Hazard Communication Standard may be used. (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(f), (k), and (q). It is a significant new use to import the substance other than in solution. (iv) Release to water. Requirements as specified in Sec. 721.90(a)(4), (b)(4), and (c)(4) where N = 55. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (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. (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. [emsp14]721.11105 to subpart E to read as follows: Sec. [emsp14]721.11105 Ethanaminium, alkyl-, salt with triazole (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as ethanaminium, alkyl-, salt with triazole (PMN P-16-533) 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), (a)(3), when determining which persons are reasonably likely to be exposed as [[Page 43553]] 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, (a)(6)(particulate), (a)(6)(v), (vi), (b) (concentration set 0.1 percent), and (c). (ii) Hazard communication. Requirements as specified in Sec. 721.72(a) through (e)(concentration set 0.1 percent), (f), (g)(1)(i), (iii), (v), (vii), (ix), (g)(2)(i), (ii), (iii), (v), (g)(3)(i), (ii), (g)(4)(iii), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System (GHS) and OSHA Hazard Communication Standard may be used. (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(k) and (q). It is a significant new use to modify the manufacture, process or use activities if it results in inhalation exposure to vapor, dust, mist or aerosols to the substance. (iv) 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. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (i) and (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. (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 13. Add Sec. [emsp14]721.11106 to subpart E to read as follows: Sec. [emsp14]721.11106 Substituted-(hydroxyalkyl)-alkyl-alkanoic acid, hydroxy-(substitutedalkyl)-alkyl-, polymer with alpha-hydro- omega-hydroxypoly[oxy (alkylethanediyl)] and isocyanato- (isocyanatoalkyl)-multialkylcycloalkane, salt, alkanol-blocked, compds. (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as substituted-(hydroxyalkyl)-alkyl-alkanoic acid, hydroxy- (substitutedalkyl)-alkyl-, polymer with alpha-hydro-omega-hydroxypoly [oxy(alkylethanediyl)] and isocyanato-(isocyanatoalkyl)- multialkylcycloalkane, salt, alkanol-blocked, compds. (PMN P-16-595) 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(f) and (k). It is a significant new use to import the substance other than as required in the Order. (ii) 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. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) (b), (c), (i), and (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. (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 14. Add Sec. [emsp14]721.11107 to subpart E to read as follows: Sec. [emsp14]721.11107 Alkanediol, 2,2-bis (substituted alkyl)- polymer with substituted alkane, heteromonocycles, alkenoate (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkanediol, 2,2-bis (substituted alkyl)- polymer with substituted alkane, heteromonocycles, alkenoate (PMN P-17-170) 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 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 0.1 percent), and (c) (ii) Hazard communication. Requirements as specified in Sec. 721.72(a) through (e)(concentration set 0.1 percent), (f), (g)(1)(i), (ii), (v), (vii), (ix), (g)(2)(i), (v), (g)(4) and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System (GHS) and OSHA Hazard Communication Standard may be used. (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80 (k)(ultraviolet curable coating resin for three dimensional printing applications) and (p)(105,000 kilograms). It is a significant new use to modify the manufacture, process or use activities if it results in inhalation exposure to vapor, dust, mist or aerosols to the substance. It is a significant new use to manufacture the chemical substance containing greater than 0.1 percent residual isocyanate or an average molecular weight below 1,000 daltons. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (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. (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 15. Add Sec. [emsp14]721.11108 to subpart E to read as follows: Sec. [emsp14]721.11108 Sulfurized alkylphenol, calcium salts (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as sulfurized alkylphenol, calcium salts (PMN P-17-172) 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(k). It is a significant new use to modify the manufacture, process or use activities if it results in inhalation exposure to vapor, dust, mist or aerosols to the substance. (ii) [Reserved] (b) Specific requirements. The provisions of subpart A of this part [[Page 43554]] apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), and (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. 0 16. Add Sec. [emsp14]721.11109 to subpart E to read as follows: Sec. [emsp14]721.11109 Monoheteropentacycloalkane-4-carboxylic acid, substituted cyclo-alkyl ester (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as monoheteropentacycloalkane-4-carboxylic acid, substituted cyclo-alkyl ester (PMN P-17-177) 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)(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 0.1 percent), and (c). (ii) Hazard communication. Requirements as specified in Sec. 721.72(a) through (e)(concentration set 0.1 percent), (f), (g)(1)(i), (ii), (iv), (vi), (vii), (ix), (skin, eye, and mucous membrane irritation), (g)(2)(i), (ii), (iii), (v), (g)(3)(i), (ii), (g)(4)(i), (ii), (iii) and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System (GHS) and OSHA Hazard Communication Standard may be used. (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(f), (k), and (t). (iv) 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. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (i) and (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. (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. [emsp14]721.11110 to subpart E to read as follows: Sec. [emsp14]721.11110 Modified carboxypolyamine salt (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as modified carboxypolyamine salt (PMN P-17-179) 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), 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, (a)(6)(particulate), (a)(6)(v), (vi), (b)(concentration set 0.1 percent), and (c). (ii) Hazard communication. Requirements as specified in Sec. 721.72(a) through (e)(concentration set 0.1 percent), (f), (g)(1)(i), (ii), (g)(2)(i), (ii), (v), (g)(3)(i), (ii), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System (GHS) and OSHA Hazard Communication Standard may be used. (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(f), (k)(dispersive additive for pigments in industrial paints and coatings) and (q). It is a significant new use to process or use the substance in a paint or coating formulation greater than 1 percent by weight or volume. It is a significant new use to process or use the substance resulting in inhalation exposure to a vapor, dust, mist or aerosol at greater than 1 percent by weight or volume. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (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. (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 18. Add Sec. [emsp14]721.11111 to subpart E to read as follows: Sec. [emsp14]721.11111 1,3,5-Triazine-2,4-diamine, 6-phenyl-, reaction products with polyalkylene glycol mono- alkyl ether and 2,4- toluene diisocyanate (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as 1,3,5- triazine-2,4-diamine, 6-phenyl-, reaction products with polyalkylene glycol mono-alkyl ether and 2,4-toluene diisocyanate (PMN P-17-222) 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 reacted (cured). (2) The significant new uses are: (i) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(k)(use of the substance in the formulation for the use allowed in the Order with isocyanate residuals not greater than 0.1 percent by weight or volume). It is a significant new use to process or use the chemical substance other than for commercial use but without any use in a consumer setting. It is a significant new use to modify the manufacture, process or use activities if it results in inhalation exposure to vapor, dust, mist or aerosols to the substance. It is a significant new use to import the chemical substance containing greater than 0.15 percent residual isocyanate. (ii) [Reserved] (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), and (i) are applicable to manufacturers and processors of this substance. [[Page 43555]] (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 19. Add Sec. [emsp14]721.11112 to subpart E to read as follows: Sec. [emsp14]721.11112 Fatty acids, polymers with benzoic acid, cyclohexanedicarboxylic acid anhydride, aliphatic diisocyanate, alkyl diol, alkyl triol, pentaerythritol, phthalic anhydride, polyalkylene glycol amine, and aromatic dicarboxylate sulfonic acid sodium salt (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as fatty acids, polymers with benzoic acid, cyclohexanedicarboxylic acid anhydride, aliphatic diisocyanate, alkyl diol, alkyl triol, pentaerythritol, phthalic anhydride, polyalkylene glycol amine, and aromatic dicarboxylate sulfonic acid sodium salt (PMN P-17-231) 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 the chemical substance containing greater than 0.1 percent residual isocyanate. (ii) [Reserved] (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), and (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 20. Add Sec. [emsp14]721.11113 to subpart E to read as follows: Sec. [emsp14]721.11113 Branched alkyl (C = 17) carboxylic acid (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as branched alkyl (C = 17) carboxylic acid (PMN P-17-247) 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), (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 1.0 percent), and (c). (ii) Hazard communication. Requirements as specified in Sec. 721.72(a) through (e)(concentration set 1.0 percent), (f), (g)(1)(irritation), (sensitization), (g)(1)(iv), (vi), (ix), (g)(2)(i), (ii), (iii), (v), (g)(3)(i), (ii), (g)(4)(iii), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System (GHS) and OSHA Hazard Communication Standard may be used. (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(f), (g) and (q). It is a significant new use to modify the manufacture, process or use activities if it results in inhalation exposure to vapor, dust, mist or aerosols to the substance. (iv) 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. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (i) and (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. (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 21. Add Sec. [emsp14]721.11114 to subpart E to read as follows: Sec. [emsp14]721.11114 Branched alkyl (C = 18) alcohol (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as branched alkyl (C = 18) alcohol (PMN P-17-248) 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), (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 1.0 percent), and (c). (ii) Hazard communication. Requirements as specified in Sec. 721.72(a) through (e)(concentration set 1.0 percent), (f), (g)(1)(irritation), (sensitization), (g)(1)(iv), (vi), (ix), (g)(2)(i), (ii),)(iii), (v), (g)(3)(i), (ii), (g)(4)(iii), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System (GHS) and OSHA Hazard Communication Standard may be used. (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(f), (g) and (q). It is a significant new use to modify the manufacture, process or use activities if it results in inhalation exposure to vapor, dust, mist or aerosols to the substance. (iv) 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. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (i) and (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. (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 22. Add Sec. [emsp14]721.11115 to subpart E to read as follows: Sec. [emsp14]721.11115 Alkoxy silane modified butadiene styrene copolymer (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkoxy silane modified [[Page 43556]] butadiene styrene copolymer (PMN P-17-260) 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(k). It is a significant new use to modify the manufacture, process or use activities if it results in inhalation exposure to vapor, dust, mist or aerosols to 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. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), and (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of this section. [FR Doc. 2018-18403 Filed 8-24-18; 8:45 am] BILLING CODE 6560-50-P
![43538 Federal Register / Vol. 83, No. 166 / Monday, August 27, 2018 / Rules and Regulations
statements that meet the criteria of the 19 chemical substances for an activity For general information contact: The
Globally Harmonized System (GHS) and that is designated as a significant new TSCA-Hotline, ABVI-Goodwill, 422
OSHA Hazard Communication Standard use by this rule to notify EPA at least South Clinton Ave., Rochester, NY
may be used. 90 days before commencing that 14620; telephone number: (202) 554–
(iii) Industrial, commercial, and activity. The required notification 1404; email address: TSCA-Hotline@
consumer activities. Requirements as initiates EPA’s evaluation of the epa.gov.
specified in § 721.80(q). It is a intended use within the applicable SUPPLEMENTARY INFORMATION:
significant new use to use the substance review period. Persons may not
other than as an aromatic polyester commence manufacture or processing I. General Information
polyol for manufacturing rigid foam. It for the significant new use until EPA A. Does this action apply to me?
is a significant new use to manufacture has conducted a review of the notice,
the substance with residual phthalate made an appropriate determination on You may be potentially affected by
greater than 0.1% by weight. It is a the notice, and has taken such actions this action if you manufacture, process,
significant new use to modify the as are required with that determination. or use the chemical substances
manufacturing, processing or use contained in this rule. The following list
DATES: This rule is effective on October
activities of the PMN substance to result of North American Industrial
26, 2018. For purposes of judicial Classification System (NAICS) codes is
in the generation of a vapor, mist or review, this rule shall be promulgated at
aerosol. not intended to be exhaustive, but rather
1 p.m. (e.s.t.) on September 10, 2018. provides a guide to help readers
(iv) Release to water. Requirements as Written adverse comments on one or
specified in § 721.90(a)(1), (b)(1), and determine whether this document
more of these SNURs must be received applies to them. Potentially affected
(c)(1). on or before September 26, 2018 (see
(b) Specific requirements. The entities may include:
Unit VI. of the SUPPLEMENTARY • Manufacturers or processors of one
provisions of subpart A of this part INFORMATION). If EPA receives written or more subject chemical substances
apply to this section except as modified adverse comments on one or more of (NAICS codes 325 and 324110), e.g.,
by this paragraph (b). these SNURs before September 26, 2018, chemical manufacturing and petroleum
(1) Recordkeeping. Recordkeeping EPA will withdraw the relevant sections refineries.
requirements as specified in of this direct final rule before its This action may also affect certain
§ 721.125(a) through (i) and (k) are effective date. entities through pre-existing import
applicable to manufacturers and For additional information on related certification and export notification
processors of this substance. reporting requirement dates, see Units rules under TSCA. Chemical importers
(2) Limitations or revocation of I.A., VI., and VII. of the SUPPLEMENTARY are subject to the TSCA section 13 (15
certain notification requirements. The INFORMATION. U.S.C. 2612) import certification
provisions of § 721.185 apply to this ADDRESSES: Submit your comments, requirements promulgated at 19 CFR
section. identified by docket identification (ID) 12.118 through 12.127 and 19 CFR
(3) Determining whether a specific use number EPA–HQ–OPPT–2017–0464, by 127.28. Chemical importers must certify
is subject to this section. The provisions one of the following methods: that the shipment of the chemical
of § 721.1725(b)(1) apply to paragraph • Federal eRulemaking Portal: http:// substance complies with all applicable
(a)(2)(iii) of this section. www.regulations.gov. Follow the online rules and orders under TSCA. Importers
[FR Doc. 2018–18534 Filed 8–24–18; 8:45 am] instructions for submitting comments. of chemicals subject to these SNURs
BILLING CODE 6560–50–P Do not submit electronically any must certify their compliance with the
information you consider to be SNUR requirements. The EPA policy in
Confidential Business Information (CBI) support of import certification appears
ENVIRONMENTAL PROTECTION or other information whose disclosure is at 40 CFR part 707, subpart B. In
AGENCY restricted by statute. addition, any persons who export or
• Mail: Document Control Office intend to export a chemical substance
40 CFR Parts 9 and 721 (7407M), Office of Pollution Prevention that is the subject of this rule on or after
[EPA–HQ–OPPT–2017–0464; FRL–9982–24] and Toxics (OPPT), Environmental September 26, 2018 are subject to the
Protection Agency, 1200 Pennsylvania export notification provisions of TSCA
RIN 2070–AB27 Ave. NW, Washington, DC 20460–0001. section 12(b) (15 U.S.C. 2611(b)) (see
• Hand Delivery: To make special § 721.20), and must comply with the
Significant New Use Rules on Certain arrangements for hand delivery or
Chemical Substances export notification requirements in 40
delivery of boxed information, please CFR part 707, subpart D.
AGENCY: Environmental Protection follow the instructions at http://
Agency (EPA). www.epa.gov/dockets/contacts.html. B. What should I consider as I prepare
Additional instructions on my comments for EPA?
ACTION: Direct final rule.
commenting or visiting the docket, 1. Submitting CBI. Do not submit this
SUMMARY: EPA is promulgating along with more information about information to EPA through
significant new use rules (SNURs) under dockets generally, is available at http:// regulations.gov or email. Clearly mark
the Toxic Substances Control Act www.epa.gov/dockets. the part or all of the information that
(TSCA) for 19 chemical substances FOR FURTHER INFORMATION CONTACT: you claim to be CBI. For CBI
which were the subject of For technical information contact: information in a disk or CD–ROM that
premanufacture notices (PMNs). The Kenneth Moss, Chemical Control you mail to EPA, mark the outside of the
amozie on DSK3GDR082PROD with RULES
chemical substances are subject to Division (7405M), Office of Pollution disk or CD–ROM as CBI and then
Orders issued by EPA pursuant to Prevention and Toxics, Environmental identify electronically within the disk or
section 5(e) of TSCA. This action Protection Agency, 1200 Pennsylvania CD–ROM the specific information that
requires persons who intend to Ave. NW, Washington, DC 20460–0001; is claimed as CBI. In addition to one
manufacture (defined by statute to telephone number: (202) 564–9232; complete version of the comment that
include import) or process any of these email address: moss.kenneth@epa.gov. includes information claimed as CBI, a
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![Federal Register / Vol. 83, No. 166 / Monday, August 27, 2018 / Rules and Regulations 43541
a consumer setting (as that term is 3. No use of the substance other than sections 5(a)(3)(B)(ii)(I) and
defined in 40 CFR 721.3); allowed by the Order which is the 5(e)(1)(A)(ii)(I), based on a finding that
6. Not exceed the confidential annual confidential coating system described in the substance may present an
production volume limit in the Order; the PMN; unreasonable risk of injury to health and
and 4. Manufacture not to exceed an the environment. To protect against
7. No manufacture of the substance annual manufacture volume of 100 potential risks, the Order requires:
where there is more than 0.2% residual kilograms; 1. Submission to EPA of certain
isocyanate. 5. Refrain from domestic manufacture toxicity testing before exceeding the
The SNUR designates as a ‘‘significant in the United States (i.e., import only); confidential production volume limit
new use’’ the absence of these protective and specified in the Order;
measures. 6. No release of the PMN substance to 2. Use of personal protective
Potentially useful information: EPA surface waters. equipment to prevent dermal exposure
has determined that certain information The SNUR designates as a ‘‘significant (where there is a potential for inhalation
about the toxicity of the PMN substance new use’’ the absence of these protective exposures);
may be potentially useful to characterize measures. 3. Establishment and use of a hazard
Potentially useful information: EPA communication program, including
the health effects of the PMN substance
has determined that certain information precautionary statements on each label
in support of a request by the PMN
about the toxicity of the PMN substance and in SDS;
submitter to modify the Order, or if a
may be potentially useful to characterize 4. No processing or use of the
manufacturer or processor is
the health effects of the PMN substance substance at temperatures greater than
considering submitting a SNUN for a
in support of a request by the PMN 200 degrees Celsius; and
significant new use that will be
submitter to modify the Order, or if a 5. No domestic manufacture of the
designated by this SNUR. The submitter
manufacturer or processor is substance.
has agreed not to exceed the
considering submitting a SNUN for a The SNUR designates as a ‘‘significant
confidential production limit without
significant new use that will be new use’’ the absence of these protective
performing specific pulmonary and
designated by this SNUR. The submitter measures.
internal organ toxicity testing.
has agreed not to exceed the production Potentially useful information: EPA
CFR citation: 40 CFR 721.11098.
limit in the Order without performing has determined that certain information
PMN Number P–16–221 specific internal organ toxicity testing about the fate and biodegradability of
Chemical name: Fluorinated on the degradation product of the PMN the PMN substance may be potentially
organopolysilazane (generic). substance. In addition, EPA has useful to characterize the health effects
determined that the results of specific of the PMN substance in support of a
CAS number: Not available.
organ toxicity on degradations products request by the PMN submitter to modify
Effective date of TSCA section 5(e)
of the PMN substance may be the Order, or if a manufacturer or
Order: June 20, 2017.
potentially useful in characterizing the processor is considering submitting a
Basis for TSCA section 5(e) Order:
health effects of the PMN substance. SNUN for a significant new use that will
The PMN states that the substance will
Although the Order does not require be designated by this SNUR. The
be used as a coating agent for optical
this additional testing, the Order’s submitter has agreed not to exceed the
lenses. EPA identified human health
restrictions on manufacture, processing, production limit in the Order without
and environmental concerns because
distribution in commerce, use, and performing specific biodegradability
the potential degradation products of
disposal will remain in effect until the and photolysis tests.
the PMN substance may be persistent, CFR citation: 40 CFR 721.11100.
Order is modified or revoked by EPA
bioaccumulative, and toxic (PBT)
based on submission of this or other PMN Number P–16–363
chemicals. EPA estimates that the PMN
information that EPA determines is
substance degradation products will Chemical name: Blocked polyester
relevant and needed to evaluate a
persist in the environment for more than polyurethane, neutralized (generic).
modification request.
two months and estimates a CFR citation: 40 CFR 721.11099. CAS number: Not available.
bioaccumulation factor of greater than Effective date of TSCA section 5(e)
or equal to 1,000. EPA also identified PMN Number P–16–359 Order: June 20, 2017.
concerns for liver toxicity, blood Chemical name: Carbopolycycle- Basis for TSCA section 5(e) Order:
toxicity, male reproductive toxicity, and bis(diazonium), dihalo-, chloride (1:2), The PMN states that the generic (non-
toxicity to aquatic organisms, terrestrial reaction products with metal hydroxide, confidential) use of the substance will
mammals and birds based on data for 4-[(dioxoalkyl)amino]substituted be an open non-dispersive use. EPA
the PMN substance degradation benzene, 2- identified concerns for irritation,
product. The Order was issued under [(dioxoalkyl)amino]substituted benzene, sensitization, and lung toxicity based on
TSCA sections 5(a)(3)(B)(ii)(I) and 5-[(dioxoalkyl)amino]-2-hydroxy- analogy to diisocyanates and cationic
5(e)(1)(A)(ii)(I), based on a finding that substituted benzene and oxo-n- binding to lung tissue. The Order was
the substance may present an phenylalkanamide (generic). issued under TSCA sections
unreasonable risk of injury to health and CAS number: Not available. 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
the environment. To protect against Effective date of TSCA section 5(e) based on a finding that the substance
potential risks, the Order requires: Order: June 20, 2017. may present an unreasonable risk of
1. Submission to EPA of certain Basis for TSCA section 5(e) Order: injury to human health. To protect
toxicity testing before exceeding a total The PMN states that the generic (non- against potential risks, the Order
amozie on DSK3GDR082PROD with RULES
production volume of 204 kilograms, as confidential) use of the substance will requires:
specified in the Order; be as a pigment additive for industrial 1. Use personal protective equipment
2. Use of personal protective coatings. EPA identified concerns for to prevent dermal exposure (where there
equipment to prevent dermal exposure oncogenicity and mutagenicity for the is a potential for dermal exposures);
(where there is a potential for dermal PMN substance degradation product. 2. Establishment and use of a hazard
exposures); The Order was issued under TSCA communication program, including
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precautionary statements on each label against potential risks, the Order toxicity if the PMN substance is
and in the SDS; requires: manufactured at a lower molecular
3. Manufacture (including import) the 1. Submission to EPA of certain weight. The Order was issued under
substance with a residual of free toxicity testing before exceeding the TSCA sections 5(a)(3)(B)(ii)(I) and
isocyanate monomers no greater than confidential production volume limit 5(e)(1)(A)(ii)(I), based on a finding that
0.1% by weight; specified in the Order; the substance may present an
4. Refraining from manufacture, 2. Use of personal protective unreasonable risk of injury to health and
processing, or use activities if it results equipment to prevent dermal exposure the environment. To protect against
in inhalation exposure to vapor, dust, (where there is a potential for dermal potential risks, the Order requires
mist or aerosols; exposures); manufacture of the substance at an
5. Refraining from manufacture, 3. Establishment and use of a hazard average molecular weight greater than
processing, or use for consumer use or communication program, including 2906 daltons and with 0.5 percent low
in commercial use (as that term is precautionary statements on each label weight molecular species less than 500
defined in 40 CFR 721.3) where there is and in the SDS; daltons and 1.0 percent low weight
use in a consumer setting (as that term 4. Use of a NIOSH-certified respirator molecular species less than 1,000
is defined in 40 CFR 721.3); and with an APF of at least 10 (where there daltons.
6. Manufacture, process, or use the is a potential for inhalation exposures) The SNUR designates as a ‘‘significant
substance only in an aqueous or compliance with a NCEL of 8.4 new use’’ the absence of this protective
formulation. milligrams per cubic meter as an 8-hour measure.
The SNUR designates as a ‘‘significant time-weighted average to prevent Potentially useful information: EPA
new use’’ the absence of these protective inhalation exposure. (EPA’s estimates has determined that certain information
measures. indicate that variations of the about the physical-chemical properties
Potentially useful information: EPA parameters (including batch size, and toxicity of the PMN substance may
has determined that certain information number of processing sites, days per be potentially useful to characterize the
about the toxicity of the PMN substance year of operation) of the uses identified health and environmental effects of the
may be potentially useful to characterize below would not result in inhalation PMN substance in support of a request
the health effects of the PMN substance exposure that would indicate a different by the PMN submitter to modify the
in support of a request by the PMN respirator.) Order, or if a manufacturer or processor
submitter to modify the Order, or if a 5. Refraining from modifying the is considering submitting a SNUN for a
manufacturer or processor is manufacture, processing, or use significant new use that will be
considering submitting a SNUN for a activities if it results in inhalation designated by this SNUR. EPA has
significant new use that will be exposure to vapor, dust, mist or determined that the results of physical-
designated by this SNUR. EPA has aerosols; and chemical property tests, internal organ
determined that the results of specific 6. Refraining from manufacture, effects testing, and aquatic toxicity tests
target organ toxicity testing and a processing, or use for consumer use or may be potentially useful in
sensitization test of the PMN substance in commercial use (as that term is characterizing the health and
may be potentially useful in defined in 40 CFR 721.3) where there is environmental effects of the PMN
characterizing the health effects of the use in a consumer setting (as that term substance. Although the Order does not
PMN substance. Although the Order is defined in 40 CFR 721.3). require this testing, the Order’s
does not require these tests, the Order’s The SNUR designates as a ‘‘significant restrictions on manufacture, processing,
restrictions on manufacture, processing, new use’’ the absence of these protective distribution in commerce, use, and
use, distribution in commerce, and measures. disposal will remain in effect until the
disposal will remain in effect until the Potentially Useful Information: EPA Order is modified or revoked by EPA
Order is modified or revoked by EPA has determined that certain information based on submission of this or other
based on submission of this or other about the toxicity of the PMN substance information that EPA determines is
information that EPA determines is may be potentially useful to characterize relevant and needed to evaluate a
relevant and needed to evaluate a the health effects of the PMN substance modification request
modification request. in support of a request by the PMN CFR citation: 40 CFR 721.11104.
CFR citation: 40 CFR 721.11101. submitter to modify the Order, or if a
manufacturer or processor is PMN Number P–16–487
PMN Number P–16–370 Chemical name: Benzenesulfonic acid
considering submitting a SNUN for a
Chemical name: Methoxy-terminated significant new use that will be 1,2-diazenediylbis[6-ethenyl]-3-
polysiloxane (generic). designated by this SNUR. The submitter sulfophenyl diazenyl-2-sulfophenyl
CAS number: Not available. has agreed not to exceed the production ethenyl salt (generic).
Effective date of TSCA section 5(e) limit in the Order without performing CAS number: Not available.
Order: July 18, 2017. specific pulmonary toxicity testing. Effective date of TSCA section 5(e)
Basis for TSCA section 5(e) Order: CFR citation: 40 CFR 721.11103. Order: June 27, 2017.
The PMN states that the generic (non- Basis for TSCA section 5(e) Order:
confidential) use of the substance will PMN Number P–16–376 The PMN states that the substance will
be as a crosslinker for adhesives and Chemical name: Hydroxystyrene resin be used as a yellow dye for paper. EPA
coatings. EPA identified concerns for (generic). identified concerns for developmental,
irritation to the skin, eyes, lung, and CAS number: Not available. reproductive, liver, kidney, and blood
mucous membranes and other lung Effective date of TSCA section 5(e) toxicity based for the azo reduction
amozie on DSK3GDR082PROD with RULES
effects on analogy to alkoxysilanes. The Order: June 16, 2017. products of the substance based on
Order was issued under TSCA sections Basis for TSCA section 5(e) Order: analogue data. Based on SAR analysis
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), The PMN states that the generic (non- for acid dyes, EPA predicts toxicity to
based on a finding that the substance confidential) use of the substance will aquatic organisms may occur at
may present an unreasonable risk of be for photolithography. EPA identified concentrations that exceed 55 parts per
injury to human health. To protect potential health and environmental billion (ppb) in surface waters. The
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Order was issued under TSCA sections reproductive toxicity, irritation, PMN Number P–16–595
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), as corrosion, sensitization, and Chemical name: Substituted-
well as 5(a)(3)(B)(ii)(II) and carcinogenicity based on analogy to (hydroxyalkyl)-alkyl-alkanoic acid,
5(e)(1)(A)(ii)(II), based on a finding that benzotriazole and quaternary amines. hydroxy-(substitutedalkyl)-alkyl-,
the substance may present an Based on SAR analysis of test data on polymer with alpha-hydro-omega-
unreasonable risk of injury to health and analogous benzotriazoles, EPA predicts hydroxypoly[oxy (alkylethanediyl)] and
the environment and that the substance toxicity to aquatic organisms may occur isocyanato-(isocyanatoalkyl)-
is or will be produced in substantial at concentrations that exceed 570 ppb in multialkylcycloalkane, salt, alkanol-
quantities and there is or may be surface waters. The Order was issued
blocked, compds. (generic).
significant (substantial) human under TSCA sections 5(a)(3)(B)(ii)(I) and CAS number: Not available.
exposure to the substance. To protect 5(e)(1)(A)(ii)(I), based on a finding that Effective date of TSCA section 5(e)
against potential risks, the Order the substance may present an Order: June 27, 2017.
requires: unreasonable risk of injury to health and Basis for TSCA section 5(e) Order:
1. Submission to EPA of certain the environment. To protect against The PMN states that the generic (non-
toxicity testing before exceeding the potential risks, the Order requires: confidential) use of the substance will
confidential production volume limits 1. Submission to EPA of certain
be as a polymer. EPA identified
specified in the Order; toxicity testing before exceeding the
concerns for irritation to skin, eyes, and
2. Use of personal protective confidential production volume limits
lung, kidney and developmental effects
equipment to prevent dermal exposure specified in the Order;
2. Use of personal protective based on functional groups present as
(where there is a potential for dermal part of the PMN structure. Based on
exposures); equipment to prevent dermal exposure
(where there is a potential for dermal SAR analysis of test data on analogous
3. Establishment and use of a hazard
exposure); polyanionic polymers, EPA identified
communication program, including
3. Establishment and use of a hazard potential environmental toxicity if the
precautionary statements on each label
communication program, including substance is produced with a different
and in the SDS;
precautionary statements on each label average molecular weight or proportion
4. No manufacture of the substance in
and in the SDS; of repeating units. The Order was issued
the United States (i.e. import only);
5. Import the substance only as a 4. Refrain from manufacture, process under TSCA sections 5(a)(3)(B)(ii)(I) and
solution; or use activities that result in inhalation 5(e)(1)(A)(ii)(I), based on a finding that
6. No use of the substance other than exposure to vapor, dust, mist or the substance may present an
for the confidential uses allowed in the aerosols; unreasonable risk of injury to health and
Order; and 5. No use other than confidential use the environment. To protect against
7. Not release the substance in surface allowed by the Order; and potential risks, the Order requires:
waters resulting in concentrations that 6. No release of the substance to 1. No manufacture of the substance in
exceed 55 ppb. surface waters. the United States (i.e. import only);
The SNUR designates as a ‘‘significant The SNUR designates as a ‘‘significant 2. Import of the substance under the
new use’’ the absence of these protective new use’’ the absence of these protective confidential conditions required by the
measures. measures. Order;
Potentially useful information: EPA Potentially useful information: EPA 3. No use of the substance other than
has determined that certain information has determined that certain information as the confidential use allowed
about the fate and toxicity of the PMN about the toxicity of the PMN substance described in the Order; and
substance may be potentially useful to may be potentially useful to characterize 4. No release of the substance to
characterize the health and the health and environmental effects of surface waters.
environmental effects of the PMN the PMN substance in support of a The SNUR designates as a ‘‘significant
substance in support of a request by the request by the PMN submitter to modify new use’’ the absence of these protective
PMN submitter to modify the Order, or the Order, or if a manufacturer or measures.
if a manufacturer or processor is processor is considering submitting a Potentially useful information: EPA
considering submitting a SNUN for a SNUN for a significant new use that will has determined that certain information
significant new use that will be be designated by this SNUR. The about the physical-chemical properties
designated by this SNUR. The submitter submitter has agreed not to exceed the and toxicity of the PMN substance may
has agreed not to exceed the production production limit in the Order without be potentially useful to characterize the
limit in the Order without performing performing specific internal organ health and environmental effects of the
specific photolysis, internal organ effects testing of the PMN substance. In PMN substance in support of a request
effects, reproductive/developmental addition, EPA has determined that the by the PMN submitter to modify the
toxicity, and aquatic toxicity tests. results of acute and chronic aquatic Order, or if a manufacturer or processor
CFR citation: 40 CFR 721.11105. toxicity testing may be potentially is considering submitting a SNUN for a
useful in characterizing the significant new use that will be
PMN Number P–16–533 environmental effects of the PMN designated by this SNUR. EPA has
Chemical name: Ethanaminium, substance. Although the Order does not determined that the results of physical-
alkyl-, salt with triazole (generic). require this additional testing, the chemical property measurements, acute
CAS number: Not available. Order’s restrictions on manufacture, toxicity tests, and acute and chronic
Effective date of TSCA section 5(e) processing, distribution in commerce, aquatic toxicity tests may be potentially
Order: July 24, 2017. use, and disposal will remain in effect useful in characterizing the health and
amozie on DSK3GDR082PROD with RULES
Basis for TSCA section 5(e) Order: until the Order is modified or revoked environmental effects of the PMN
The PMN states that the generic (non- by EPA based on submission of this or substance. Although the Order does not
confidential) use of the substance will other information that EPA determines require this additional testing, the
be as a cleaning agent for electronics is relevant and needed to evaluate a Order’s restrictions on manufacture,
manufacture. EPA identified concerns modification request. processing, distribution in commerce,
for neurotoxicity, developmental and CFR citation: 40 CFR 721.11105. use, and disposal will remain in effect
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already been approved by OMB been impacted by these rulemakings, NTTAA section 12(d) (15 U.S.C. 272
pursuant to PRA under OMB control and EPA does not have any reasons to note), does not apply to this action.
number 2070–0012 (EPA ICR No. 574). believe that any State, local, or Tribal
This action does not impose any burden government will be impacted by this J. Executive Order 12898
requiring additional OMB approval. If action. As such, EPA has determined This action does not entail special
an entity were to submit a SNUN to the that this action does not impose any considerations of environmental justice
Agency, the annual burden is estimated enforceable duty, contain any unfunded related issues as delineated by
to average between 30 and 170 hours mandate, or otherwise have any effect Executive Order 12898, entitled
per response. This burden estimate on small governments subject to the ‘‘Federal Actions to Address
includes the time needed to review requirements of UMRA sections 202, Environmental Justice in Minority
instructions, search existing data 203, 204, or 205 (2 U.S.C. 1501 et seq.).
Populations and Low-Income
sources, gather and maintain the data
E. Executive Order 13132 Populations’’ (59 FR 7629, February 16,
needed, and complete, review, and
This action will not have a substantial 1994).
submit the required SNUN.
Send any comments about the direct effect on States, on the XIII. Congressional Review Act
accuracy of the burden estimate, and relationship between the national
any suggested methods for minimizing government and the States, or on the Pursuant to the Congressional Review
respondent burden, including through distribution of power and Act (5 U.S.C. 801 et seq.), EPA will
the use of automated collection responsibilities among the various submit a report containing this rule and
techniques, to the Director, Collection levels of government, as specified in other required information to the U.S.
Strategies Division, Office of Executive Order 13132, entitled Senate, the U.S. House of
Environmental Information (2822T), ‘‘Federalism’’ (64 FR 43255, August 10, Representatives, and the Comptroller
Environmental Protection Agency, 1200 1999). General of the United States prior to
Pennsylvania Ave. NW, Washington, DC F. Executive Order 13175 publication of the rule in the Federal
20460–0001. Please remember to Register. This action is not a ‘‘major
include the OMB control number in any This action does not have Tribal rule’’ as defined by 5 U.S.C. 804(2).
correspondence, but do not submit any implications because it is not expected
to have substantial direct effects on List of Subjects
completed forms to this address.
Indian Tribes. This action does not 40 CFR Part 9
C. Regulatory Flexibility Act (RFA) significantly nor uniquely affect the
On February 18, 2012, EPA certified communities of Indian Tribal Environmental protection, Reporting
pursuant to RFA section 605(b) (5 U.S.C. governments, nor does it involve or and recordkeeping requirements.
601 et seq.), that promulgation of a impose any requirements that affect
SNUR does not have a significant Indian Tribes. Accordingly, the 40 CFR Part 721
economic impact on a substantial requirements of Executive Order 13175,
Environmental protection, Chemicals,
number of small entities where the entitled ‘‘Consultation and Coordination
Hazardous substances, Reporting and
following are true: with Indian Tribal Governments’’ (65 FR
recordkeeping requirements.
1. A significant number of SNUNs 67249, November 9, 2000), do not apply
would not be submitted by small to this action. Dated: August 17, 2018.
entities in response to the SNUR. G. Executive Order 13045
Jeffery T. Morris,
2. The SNUR submitted by any small Director, Chemical Control Division, Office
entity would not cost significantly more This action is not subject to Executive of Pollution Prevention and Toxics.
than $8,300. Order 13045, entitled ‘‘Protection of
A copy of that certification is Children from Environmental Health Therefore, 40 CFR parts 9 and 721 are
available in the docket for this action. Risks and Safety Risks’’ (62 FR 19885, amended as follows:
This action is within the scope of the April 23, 1997), because this is not an
February 18, 2012 certification. Based economically significant regulatory PART 9—[AMENDED]
on the Economic Analysis discussed in action as defined by Executive Order
Unit XI. and EPA’s experience 12866, and this action does not address ■ 1. The authority citation for part 9
promulgating SNURs (discussed in the environmental health or safety risks continues to read as follows:
certification), EPA believes that the disproportionately affecting children. Authority: 7 U.S.C. 135 et seq., 136–136y;
following are true: H. Executive Order 13211 15 U.S.C. 2001, 2003, 2005, 2006, 2601–2671;
• A significant number of SNUNs 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33
would not be submitted by small This action is not subject to Executive U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318,
entities in response to the SNUR. Order 13211, entitled ‘‘Actions 1321, 1326, 1330, 1342, 1344, 1345(d) and
• Submission of the SNUN would not Concerning Regulations That (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,
cost any small entity significantly more Significantly Affect Energy Supply, 1971–1975 Comp. p. 973; 42 U.S.C. 241,
than $8,300. Distribution, or Use’’ (66 FR 28355, May 242b, 243, 246, 300f, 300g, 300g–1, 300g–2,
Therefore, the promulgation of the 22, 2001), because this action is not 300g–3, 300g–4, 300g–5, 300g–6, 300j–1,
SNUR would not have a significant expected to affect energy supply, 300j–2, 300j–3, 300j–4, 300j–9, 1857 et seq.,
economic impact on a substantial distribution, or use and because this 6901–6992k, 7401–7671q, 7542, 9601–9657,
number of small entities. action is not a significant regulatory 11023, 11048.
action under Executive Order 12866.
amozie on DSK3GDR082PROD with RULES
D. Unfunded Mandates Reform Act ■ 2. In § 9.1, add the following sections
(UMRA) I. National Technology Transfer and in numerical order under the
Based on EPA’s experience with Advancement Act (NTTAA) undesignated center heading
proposing and finalizing SNURs, State, In addition, since this action does not ‘‘Significant New Uses of Chemical
local, and Tribal governments have not involve any technical standards, Substances’’ to read as follows:
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![43550 Federal Register / Vol. 83, No. 166 / Monday, August 27, 2018 / Rules and Regulations
§ 9.1 OMB approvals under the Paperwork (iii) Disposal. Requirements as alternative to § 721.63 respirator
Reduction Act. specified in § 721.85(a)(1), (2), (b)(1), (2), requirements may request to do so
* * * * * (c)(1), and (2). under § 721.30. Persons whose § 721.30
(iv) Release to water. Requirements as requests to use the NCELs approach are
40 CFR citation OMB specified in § 721.90(a)(1), (b)(1), and approved by EPA will be required to
control No. (c)(1). follow NCELs provisions comparable to
(b) Specific requirements. The those contained in the corresponding
* * * * *
provisions of subpart A of this part TSCA section 5(e) Order.
apply to this section except as modified (B) [Reserved]
Significant New Uses of Chemical by this paragraph. (ii) Hazard communication.
Substances (1) Recordkeeping. Recordkeeping Requirements as specified in § 721.72(a)
requirements as specified in through (e)(concentration set 1.0
§ 721.125(a), (b), (c), and (f) through (k) percent), (f), (g)(1)(ii), (g)(2)(ii), (iii), (use
* * * * * are applicable to manufacturers and respiratory protection or maintain
721.11097 ............................. 2070–0012 processors of this substance. workplace airborne concentrations at or
721.11098 ............................. 2070–0012
(2) Limitations or revocation of below an 8-hour time-weighted average
721.11099 ............................. 2070–0012
721.11100 ............................. 2070–0012 certain notification requirements. The of 0.9 mg/m3), and (g)(5). Alternative
721.11101 ............................. 2070–0012 provisions of § 721.185 apply to this hazard and warning statements that
721.11102 ............................. 2070–0012 section. meet the criteria of the Globally
721.11103 ............................. 2070–0012 (3) Determining whether a specific use Harmonized System (GHS) and OSHA
721.11104 ............................. 2070–0012 is subject to this section. The provisions Hazard Communication Standard may
721.11105 ............................. 2070–0012 of § 721.1725(b)(1) apply to paragraph be used.
721.11106 ............................. 2070–0012 (a)(2)(iii) of this section. (iii) Industrial, commercial, and
721.11107 ............................. 2070–0012 consumer activities. Requirements as
■ 5. Add § 721.11098 to subpart E to
721.11108 ............................. 2070–0012
read as follows: specified in § 721.80(k), (q) and (t). It is
721.11109 ............................. 2070–0012
721.11110 ............................. 2070–0012 a significant new use to process or use
§ 721.11098 Polyethylene glycol polymer the chemical substance other than for
721.11111 ............................. 2070–0012 with aliphatic polycarbodiimide
721.11112 ............................. 2070–0012 commercial use but without any use in
bis(alkoxysilylpropyl) amine blocked
721.11113 ............................. 2070–0012 (generic).
a consumer setting. It is a significant
721.11114 ............................. 2070–0012 new use to manufacture the chemical
721.11115 ............................. 2070–0012 (a) Chemical substance and substance containing greater than 0.2%
significant new uses subject to reporting. residual isocyanate.
* * * * * (1) The chemical substance identified (b) Specific requirements. The
generically as polyethylene glycol provisions of subpart A of this part
* * * * * polymer with aliphatic apply to this section except as modified
polycarbodiimide bis(alkoxysilylpropyl) by this paragraph.
PART 721—[AMENDED] amine blocked (PMN P–16–99) is (1) Recordkeeping. Recordkeeping
subject to reporting under this section requirements as specified in
■ 3. The authority citation for part 721 for the significant new uses described in § 721.125(a) through (i) are applicable to
continues to read as follows: paragraph (a)(2) of this section. manufacturers and processors of this
Authority: 15 U.S.C. 2604, 2607, and (2) The significant new uses are: substance.
2625(c). (i) Protection in the workplace. (2) Limitations or revocation of
Requirements as specified in certain notification requirements. The
■ 4. Add § 721.11097 to subpart E to § 721.63(a)(1), (a)(2)(i), (a)(3), (a)(4),
read as follows: provisions of § 721.185 apply to this
when determining which persons are section.
§ 721.11097 Benzene, 1,4-bis(alkyl)-, reasonably likely to be exposed as (3) Determining whether a specific use
homopolymer (generic). required for § 721.63(a)(1) and (a)(4), is subject to this section. The provisions
engineering control measures (e.g., of § 721.1725(b)(1) apply to paragraph
(a) Chemical substance and
enclosure or confinement of the (a)(2)(iii) of this section.
significant new uses subject to reporting.
operation, general and local ventilation) ■ 6. Add § 721.11099 to subpart E to
(1) The chemical substance identified
or administrative control measures (e.g., read as follows:
generically benzene, 1,4-bis(alkyl)-,
workplace policies and procedures)
homopolymer (PMN P–15–719) is
shall be considered and implemented to § 721.11099 Fluorinated
subject to reporting under this section
prevent exposure, where feasible, (a)(5) organopolysilazane (generic).
for the significant new uses described in
(respirators must provide a National (a) Chemical substance and
paragraph (a)(2) of this section.
Institute for Occupational Safety and significant new uses subject to reporting.
(2) The significant new uses are: Health (NIOSH) with an assigned (1) The chemical substance identified
(i) Hazard communication. protection factor (APF) of at least 10), generically as a fluorinated
Requirements as specified in § 721.72(a) (a)(6)(particulate), (b)(concentrations set organopolysilazane (PMN P–16–221) is
through (e)(concentrations set at 1.0 at 1.0 percent) and (c). subject to reporting under this section
percent), (f), (g)(4)(i), (iii), and (g)(5). (A) As an alternative to the respirator for the significant new uses described in
Alternative hazard and warning requirements in paragraph (a)(2)(i) of paragraph (a)(2) of this section.
statements that meet the criteria of the this section, a manufacturer or processor (2) The significant new uses are:
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Globally Harmonized System (GHS) and may choose to follow the new chemical (i) Protection in the workplace.
OSHA Hazard Communication Standard exposure limit (NCEL) provision listed Requirements as specified in
may be used. in the TSCA section 5(e) Order for this § 721.63(a)(1), (a)(3), (a)(4), when
(ii) Industrial, commercial, and substance. The NCEL is 0.9 mg/m3 as an determining which persons are
consumer activities. Requirements as 8-hour time weighted average. Persons reasonably likely to be exposed as
specified in § 721.80(k) and (q). who wish to pursue NCELs as an required for § 721.63(a)(1) engineering
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control measures (e.g., enclosure or required for § 721.63(a)(1), engineering operation, general and local ventilation)
confinement of the operation, general control measures (e.g., enclosure or or administrative control measures (e.g.,
and local ventilation) or administrative confinement of the operation, general workplace policies and procedures)
control measures (e.g., workplace and local ventilation) or administrative shall be considered and implemented to
policies and procedures) shall be control measures (e.g., workplace prevent exposure, where feasible,
considered and implemented to prevent policies and procedures) shall be (a)(2)(i), (ii), (iii), (a)(3),
exposure, where feasible, considered and implemented to prevent (a)(6)(particulate), (a)(6)(v), (vi)
(a)(6)(particulate), (a)(6)(v), (vi), exposure, where feasible, (b)(concentrations set at 0.1 percent)
(b)(concentrations set at 1.0 percent), (a)(6)(particulate), (b)(concentrations set and (c).
and (c). at 0.1 percent) and (c). (ii) Hazard communication.
(ii) Industrial, commercial, and (ii) Hazard communication. Requirements as specified in § 721.72
consumer activities. Requirements as Requirements as specified in § 721.72(a) (a) through (e)(concentration set 0.1
specified in § 721.80(f), (p) (204 through (e)(concentration set 0.1 percent), (f), (g)(1)(i), (ii), (g)(2)(i), (ii),
kilograms) and (s)(100 kilograms). It is percent), (f), (g)(1)(iv), (vii), (g)(2)(i), (ii), (iii), (iv), and (g)(5). Alternative hazard
a significant new use to use the (do not process or use at greater than and warning statements that meet the
substance other than in confidential 200 degrees Celsius), and (g)(5). criteria of the Globally Harmonized
coating system allowed in the Order. Alternative hazard and warning System (GHS) and OSHA Hazard
(iii) Release to water. Requirements as statements that meet the criteria of the Communication Standard may be used.
specified in § 721.90(a)(1), (b)(1), and Globally Harmonized System (GHS) and (iii) Industrial, commercial, and
(c)(1). OSHA Hazard Communication Standard consumer activities. Requirements as
(b) Specific requirements. The may be used. specified in § 721.80 It is a significant
provisions of subpart A of this part (iii) Industrial, commercial, and new use to manufacture, process, or use
apply to this section except as modified consumer activities. Requirements as the substance with a residual of free
by this paragraph. specified in § 721.80 (f) and (q). It is a isocyanate monomers greater than 0.1
(1) Recordkeeping. Recordkeeping significant new use to process or use the percent by weight. It is a significant new
requirements as specified in PMN substance at a temperature greater use to modify manufacture, process or
§ 721.125(a) through (e), (i), and (k) are than 200 degrees C. use activities if it results in inhalation
applicable to manufacturers and (b) Specific requirements. The exposure to vapor, dust, mist or aerosols
processors of this substance. provisions of subpart A of this part to the substance. It is a significant new
(2) Limitations or revocation of apply to this section except as modified use to manufacture, process, or use the
certain notification requirements. The by this paragraph. substance for consumer use, or for
provisions of § 721.185 apply to this (1) Recordkeeping. Recordkeeping commercial uses when the saleable
section. requirements as specified in goods or service could introduce the
(3) Determining whether a specific use § 721.125(a) through (i) are applicable to substance into a consumer setting. It is
is subject to this section. The provisions manufacturers and processors of this a significant new use to manufacture,
of § 721.1725(b)(1) apply to paragraph substance. process, or use the substance other than
(a)(2)(iii) of this section. (2) Limitations or revocation of in an aqueous formulation.
certain notification requirements. The (b) Specific requirements. The
■ 7. Add § 721.11100 to subpart E to
provisions of § 721.185 apply to this provisions of subpart A of this part
read as follows:
section. apply to this section except as modified
§ 721.11100 Carbopolycycle- (3) Determining whether a specific use by this paragraph.
bis(diazonium), dihalo-, chloride (1:2), is subject to this section. The provisions (1) Recordkeeping. Recordkeeping
reaction products with metal hydroxide, 4- of § 721.1725(b)(1) apply to paragraph requirements as specified in
[(dioxoalkyl)amino]substituted benzene, 2- (a)(2)(iii) of this section. § 721.125(a) through (i) are applicable to
[(dioxoalkyl)amino]substituted benzene, 5- ■ 8. Add § 721.11101 to subpart E to manufacturers and processors of this
[(dioxoalkyl)amino]-2-hydroxy-substituted
read as follows: substance.
benzene and oxo-n-phenylalkanamide
(generic).
(2) Limitations or revocation of
§ 721.11101 Blocked polyester certain notification requirements. The
(a) Chemical substance and polyurethane, neutralized (generic). provisions of § 721.185 apply to this
significant new uses subject to reporting. (a) Chemical substance and section.
(1) The chemical substance identified significant new uses subject to reporting. ■ 9. Add § 721.11102 to subpart E to
generically as carbopolycycle- (1) The chemical substance identified read as follows:
bis(diazonium), dihalo-, chloride (1:2), generically as blocked polyester
reaction products with metal hydroxide, polyurethane, neutralized (PMN P–16– § 721.11102 Methoxy-terminated
4-[(dioxoalkyl)amino] substituted 363) is subject to reporting under this polysiloxane (generic).
benzene, 2- section for the significant new uses (a) Chemical substance and
[(dioxoalkyl)amino]substituted benzene, described in paragraph (a)(2) of this significant new uses subject to reporting.
5-[(dioxoalkyl) amino] 2-hydroxy- section. The requirements of this section (1) The chemical substance identified
substituted benzene and oxo-n- do not apply to quantities of the generically as methoxy-terminated
phenylalkanamide (PMN P–16–359) is substance after they have been reacted polysiloxane (PMN P–16–370) is subject
subject to reporting under this section (cured). to reporting under this section for the
for the significant new uses described in (2) The significant new uses are: significant new uses described in
paragraph (a)(2) of this section. (i) Protection in the workplace. paragraph (a)(2) of this section. The
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(2) The significant new uses are: Requirements as specified in requirements of this section do not
(i) Protection in the workplace. § 721.63(a)(1), when determining which apply to quantities of the substance after
Requirements as specified in persons are reasonably likely to be they have been reacted (cured).
§ 721.63(a)(1), (a)(3), (a)(4), when exposed as required for § 721.63(a)(1) (2) The significant new uses are:
determining which persons are engineering control measures (e.g., (i) Protection in the workplace.
reasonably likely to be exposed as enclosure or confinement of the Requirements as specified in
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§ 721.63(a)(1), (a)(2)(i), (ii), (iii), (a)(3), manufacturers and processors of this determining which persons are
(a)(4), when determining which persons substance. reasonably likely to be exposed as
are reasonably likely to be exposed as (2) Limitations or revocation of required for § 721.63(a)(1) engineering
required for § 721.63(a)(1) and (a)(4), certain notification requirements. The control measures (e.g., enclosure or
engineering control measures (e.g., provisions of § 721.185 apply to this confinement of the operation, general
enclosure or confinement of the section. and local ventilation) or administrative
operation, general and local ventilation) (3) Determining whether a specific use control measures (e.g., workplace
or administrative control measures (e.g., is subject to this section. The provisions policies and procedures) shall be
workplace policies and procedures) of § 721.1725(b)(1) apply to paragraph considered and implemented to prevent
shall be considered and implemented to (a)(2)(iii) of this section. exposure, where feasible, (b)
prevent exposure, where feasible, (a)(5) ■ 10. Add § 721.11103 to subpart E to (concentration set 1.0 percent), and (c).
(respirators must provide a National read as follows: (ii) Hazard communication.
Institute for Occupational Safety and Requirements as specified in § 721.72(a)
Health (NIOSH) assigned protection § 721.11103 Hydroxystyrene resin through (e)(concentration set 1.0
factor (APF) of at least 25), (generic). percent), (f), (g)(1)(iv), (vi), (ix), (blood
(a)(6)(particulate), (a)(6)(v), (vi), (a) Chemical substance and effects), (g)(2)(i), (v), (g)(3)(i), (ii),
(b)(concentrations set at 1.0 percent), significant new uses subject to reporting. (g)(4)(water release restrictions apply),
and (c). (1) The chemical substance identified and (g)(5). Alternative hazard and
(A) As an alternative to the respirator generically as hydroxystyrene resin warning statements that meet the
requirements in paragraph (a)(2)(i) of (PMN P–16–376) is subject to reporting criteria of the Globally Harmonized
this section, a manufacturer or processor under this section for the significant System (GHS) and OSHA Hazard
may choose to follow the new chemical new uses described in paragraph (a)(2) Communication Standard may be used.
exposure limit (NCEL) provision listed of this section. (iii) Industrial, commercial, and
in the TSCA section 5(e) Order for this (2) The significant new uses are: consumer activities. Requirements as
substance. The NCEL is 8.4 milligrams (i) Industrial, commercial, and specified in § 721.80(f), (k), and (q). It is
per cubic meter as an 8-hour time consumer activities. Requirements as a significant new use to import the
weighted average. Persons who wish to specified in § 721.80 It is a significant substance other than in solution.
pursue NCELs as an alternative to new use to manufacture the PMN (iv) Release to water. Requirements as
§ 721.63 respirator requirements may substance with an average molecular specified in § 721.90(a)(4), (b)(4), and
request to do so under § 721.30. Persons weight less than 2906 daltons and to (c)(4) where N = 55.
whose § 721.30 requests to use the have greater than 0.5 percent low weight (b) Specific requirements. The
NCELs approach are approved by EPA molecular species less than 500 daltons provisions of subpart A of this part
will be required to follow NCELs and 1.0 percent low weight molecular apply to this section except as modified
provisions comparable to those species less than 1000 daltons. by this paragraph.
contained in the corresponding TSCA (ii) [Reserved] (1) Recordkeeping. Recordkeeping
section 5(e) Order. (b) Specific requirements. The requirements as specified in
(B) [Reserved] provisions of subpart A of this part § 721.125(a) through (i) are applicable to
(ii) Hazard communication. apply to this section except as modified manufacturers and processors of this
Requirements as specified in § 721.72(a) by this paragraph. substance.
(1) Recordkeeping. Recordkeeping (2) Limitations or revocation of
through (e)(concentration set 1.0
requirements as specified in certain notification requirements. The
percent), (f), (g)(1)(i), (ii), (g)(2)(i), (ii),
§ 721.125(a) through (i) are applicable to provisions of § 721.185 apply to this
(iii), (use respiratory protection or
manufacturers and processors of this section.
maintain workplace airborne (3) Determining whether a specific use
substance.
concentrations at or below an 8-hour is subject to this section. The provisions
(2) Limitations or revocation of
time-weighted average of 8.4 mg/m3), of § 721.1725(b)(1) apply to paragraph
certain notification requirements. The
(g)(2)(v), (do not use for spray (a)(2)(iii) of this section.
provisions of § 721.185 apply to this
application), and (g)(5). Alternative
section. ■ 12. Add § 721.11105 to subpart E to
hazard and warning statements that
meet the criteria of the Globally ■ 11. Add § 721.11104 to subpart E to read as follows:
Harmonized System (GHS) and OSHA read as follows:
§ 721.11105 Ethanaminium, alkyl-, salt
Hazard Communication Standard may § 721.11104 Benzenesulfonic acid 1,2- with triazole (generic).
be used. diazenediylbis[6-ethenyl]-3-sulfophenyl (a) Chemical substance and
(iii) Industrial, commercial, and diazenyl-2-sulfophenyl ethenyl salt significant new uses subject to reporting.
consumer activities. Requirements as (generic). (1) The chemical substance identified
specified in § 721.80(q), and (y)(1). It is (a) Chemical substance and generically as ethanaminium, alkyl-, salt
a significant new use to manufacture, significant new uses subject to reporting. with triazole (PMN P–16–533) is subject
process, or use the substance for (1) The chemical substance identified to reporting under this section for the
consumer use, or for commercial uses generically as benzenesulfonic acid 1,2- significant new uses described in
when the saleable goods or service diazenediylbis[6-ethenyl]-3-sulfophenyl paragraph (a)(2) of this section. The
could introduce the substance into a diazenyl-2-sulfophenyl ethenyl salt requirements of this section do not
consumer setting. (PMN P–16–487) is subject to reporting apply to quantities of the substance after
(b) Specific requirements. The under this section for the significant they have been reacted (cured).
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provisions of subpart A of this part new uses described in paragraph (a)(2) (2) The significant new uses are:
apply to this section except as modified of this section. (i) Protection in the workplace.
by this paragraph. (2) The significant new uses are: Requirements as specified in
(1) Recordkeeping. Recordkeeping (i) Protection in the workplace. § 721.63(a)(1), (a)(2)(i), (ii), (iii), (a)(3),
requirements as specified in Requirements as specified in when determining which persons are
§ 721.125(a) through (i) are applicable to § 721.63(a)(1), (a)(2)(i), (a)(3), when reasonably likely to be exposed as
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required for § 721.63(a)(1) engineering subject to reporting under this section (b)(concentration set 0.1 percent), and
control measures (e.g., enclosure or for the significant new uses described in (c)
confinement of the operation, general paragraph (a)(2) of this section. The (ii) Hazard communication.
and local ventilation) or administrative requirements of this section do not Requirements as specified in § 721.72(a)
control measures (e.g., workplace apply to quantities of the substance after through (e)(concentration set 0.1
policies and procedures) shall be they have been reacted (cured). percent), (f), (g)(1)(i), (ii), (v), (vii), (ix),
considered and implemented to prevent (2) The significant new uses are: (g)(2)(i), (v), (g)(4) and (g)(5). Alternative
exposure, where feasible, (i) Industrial, commercial, and hazard and warning statements that
(a)(6)(particulate), (a)(6)(v), (vi), (b) consumer activities. Requirements as meet the criteria of the Globally
(concentration set 0.1 percent), and (c). specified in § 721.80(f) and (k). It is a Harmonized System (GHS) and OSHA
(ii) Hazard communication. significant new use to import the Hazard Communication Standard may
Requirements as specified in § 721.72(a) substance other than as required in the be used.
through (e)(concentration set 0.1 Order. (iii) Industrial, commercial, and
percent), (f), (g)(1)(i), (iii), (v), (vii), (ix), (ii) Release to water. Requirements as consumer activities. Requirements as
(g)(2)(i), (ii), (iii), (v), (g)(3)(i), (ii), specified in § 721.90(a)(1), (b)(1), and specified in § 721.80 (k)(ultraviolet
(g)(4)(iii), and (g)(5). Alternative hazard (c)(1). curable coating resin for three
and warning statements that meet the (b) Specific requirements. The dimensional printing applications) and
criteria of the Globally Harmonized provisions of subpart A of this part (p)(105,000 kilograms). It is a significant
System (GHS) and OSHA Hazard apply to this section except as modified new use to modify the manufacture,
Communication Standard may be used. by this paragraph. process or use activities if it results in
(iii) Industrial, commercial, and (1) Recordkeeping. Recordkeeping inhalation exposure to vapor, dust, mist
consumer activities. Requirements as requirements as specified in or aerosols to the substance. It is a
specified in § 721.80(k) and (q). It is a § 721.125(a) (b), (c), (i), and (k) are significant new use to manufacture the
significant new use to modify the applicable to manufacturers and chemical substance containing greater
manufacture, process or use activities if processors of this substance. than 0.1 percent residual isocyanate or
it results in inhalation exposure to (2) Limitations or revocation of an average molecular weight below
vapor, dust, mist or aerosols to the certain notification requirements. The 1,000 daltons.
substance. (b) Specific requirements. The
provisions of § 721.185 apply to this
(iv) Release to water. Requirements as provisions of subpart A of this part
section.
specified in § 721.90(a)(1), (b)(1), and apply to this section except as modified
(3) Determining whether a specific use
(c)(1). by this paragraph.
is subject to this section. The provisions (1) Recordkeeping. Recordkeeping
(b) Specific requirements. The of § 721.1725(b)(1) apply to paragraph
provisions of subpart A of this part requirements as specified in
(a)(2)(iii) of this section. § 721.125(a) through (i) are applicable to
apply to this section except as modified
by this paragraph. ■ 14. Add § 721.11107 to subpart E to manufacturers and processors of this
(1) Recordkeeping. Recordkeeping read as follows: substance.
requirements as specified in (2) Limitations or revocation of
§ 721.11107 Alkanediol, 2,2-bis
§ 721.125(a) through (i) and (k) are (substituted alkyl)- polymer with substituted certain notification requirements. The
applicable to manufacturers and alkane, heteromonocycles, alkenoate provisions of § 721.185 apply to this
processors of this substance. (generic). section.
(2) Limitations or revocation of (3) Determining whether a specific use
(a) Chemical substance and
certain notification requirements. The is subject to this section. The provisions
significant new uses subject to reporting.
provisions of § 721.185 apply to this of § 721.1725(b)(1) apply to paragraph
(1) The chemical substance identified
section. (a)(2)(iii) of this section.
generically as alkanediol, 2,2-bis
(3) Determining whether a specific use (substituted alkyl)- polymer with ■ 15. Add § 721.11108 to subpart E to
is subject to this section. The provisions substituted alkane, heteromonocycles, read as follows:
of § 721.1725(b)(1) apply to paragraph alkenoate (PMN P–17–170) is subject to § 721.11108 Sulfurized alkylphenol,
(a)(2)(iii) of this section. reporting under this section for the calcium salts (generic).
■ 13. Add § 721.11106 to subpart E to significant new uses described in (a) Chemical substance and
read as follows: paragraph (a)(2) of this section. The significant new uses subject to reporting.
requirements of this section do not (1) The chemical substance identified
§ 721.11106 Substituted-(hydroxyalkyl)-
alkyl-alkanoic acid, hydroxy-
apply to quantities of the PMN generically as sulfurized alkylphenol,
(substitutedalkyl)-alkyl-, polymer with substance after they have been reacted calcium salts (PMN P–17–172) is subject
alpha-hydro-omega-hydroxypoly[oxy (cured). to reporting under this section for the
(alkylethanediyl)] and isocyanato- (2) The significant new uses are: significant new uses described in
(isocyanatoalkyl)-multialkylcycloalkane, (i) Protection in the workplace. paragraph (a)(2) of this section.
salt, alkanol-blocked, compds. (generic). Requirements as specified in (2) The significant new uses are:
(a) Chemical substance and § 721.63(a)(1), (a)(2)(i), (a)(3), when (i) Industrial, commercial, and
significant new uses subject to reporting. determining which persons are consumer activities. Requirements as
(1) The chemical substance identified reasonably likely to be exposed as specified in § 721.80(k). It is a
generically as substituted- required for § 721.63(a)(1) engineering significant new use to modify the
(hydroxyalkyl)-alkyl-alkanoic acid, control measures (e.g., enclosure or manufacture, process or use activities if
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hydroxy-(substitutedalkyl)-alkyl-, confinement of the operation, general it results in inhalation exposure to
polymer with alpha-hydro-omega- and local ventilation) or administrative vapor, dust, mist or aerosols to the
hydroxypoly [oxy(alkylethanediyl)] and control measures (e.g., workplace substance.
isocyanato-(isocyanatoalkyl)- policies and procedures) shall be (ii) [Reserved]
multialkylcycloalkane, salt, alkanol- considered and implemented to prevent (b) Specific requirements. The
blocked, compds. (PMN P–16–595) is exposure, where feasible, provisions of subpart A of this part
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apply to this section except as modified apply to this section except as modified vapor, dust, mist or aerosol at greater
by this paragraph. by this paragraph. than 1 percent by weight or volume.
(1) Recordkeeping. Recordkeeping (1) Recordkeeping. Recordkeeping (b) Specific requirements. The
requirements as specified in requirements as specified in provisions of subpart A of this part
§ 721.125(a), (b), (c), and (i) are § 721.125(a) through (i) and (k) are apply to this section except as modified
applicable to manufacturers and applicable to manufacturers and by this paragraph.
processors of this substance. processors of this substance. (1) Recordkeeping. Recordkeeping
(2) Limitations or revocation of (2) Limitations or revocation of requirements as specified in
certain notification requirements. The certain notification requirements. The § 721.125(a) through (i) are applicable to
provisions of § 721.185 apply to this provisions of § 721.185 apply to this manufacturers and processors of this
section. section. substance.
(3) Determining whether a specific use (3) Determining whether a specific use (2) Limitations or revocation of
is subject to this section. The provisions is subject to this section. The provisions certain notification requirements. The
of § 721.1725(b)(1) apply to paragraph of § 721.1725(b)(1) apply to paragraph provisions of § 721.185 apply to this
(a)(2)(iii) of this section. (a)(2)(iii) of this section. section.
■ 16. Add § 721.11109 to subpart E to ■ 17. Add § 721.11110 to subpart E to (3) Determining whether a specific use
read as follows: read as follows: is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
§ 721.11109 § 721.11110 Modified carboxypolyamine (a)(2)(iii) of this section.
Monoheteropentacycloalkane-4-carboxylic salt (generic).
■ 18. Add § 721.11111 to subpart E to
acid, substituted cyclo-alkyl ester (generic). (a) Chemical substance and read as follows:
(a) Chemical substance and significant new uses subject to reporting.
significant new uses subject to reporting. (1) The chemical substance identified § 721.11111 1,3,5-Triazine-2,4-diamine, 6-
(1) The chemical substance identified generically as modified phenyl-, reaction products with
generically as carboxypolyamine salt (PMN P–17–179) polyalkylene glycol mono- alkyl ether and
monoheteropentacycloalkane-4- is subject to reporting under this section 2,4-toluene diisocyanate (generic).
carboxylic acid, substituted cyclo-alkyl for the significant new uses described in (a) Chemical substance and
ester (PMN P–17–177) is subject to paragraph (a)(2) of this section. The significant new uses subject to reporting.
reporting under this section for the requirements of this section do not (1) The chemical substance identified
significant new uses described in apply to quantities of the substance after generically as 1,3,5-triazine-2,4-
paragraph (a)(2) of this section. The they have been reacted (cured). diamine, 6-phenyl-, reaction products
requirements of this section do not (2) The significant new uses are: with polyalkylene glycol mono-alkyl
apply to quantities of the substance after (i) Protection in the workplace. ether and 2,4-toluene diisocyanate
they have been reacted (cured). Requirements as specified in (PMN P–17–222) is subject to reporting
(2) The significant new uses are: § 721.63(a)(1), (a)(2)(i), (iv), (a)(3), when under this section for the significant
(i) Protection in the workplace. determining which persons are new uses described in paragraph (a)(2)
Requirements as specified in reasonably likely to be exposed as of this section. The requirements of this
§ 721.63(a)(1), (a)(3), when determining required for § 721.63(a)(1) engineering section do not apply to quantities of the
which persons are reasonably likely to control measures (e.g., enclosure or PMN substance after they have been
be exposed as required for § 721.63(a)(1) confinement of the operation, general reacted (cured).
engineering control measures (e.g., and local ventilation) or administrative (2) The significant new uses are:
enclosure or confinement of the control measures (e.g., workplace (i) Industrial, commercial, and
operation, general and local ventilation) policies and procedures) shall be consumer activities. Requirements as
or administrative control measures (e.g., considered and implemented to prevent specified in § 721.80(k)(use of the
workplace policies and procedures) exposure, where feasible, substance in the formulation for the use
shall be considered and implemented to (a)(6)(particulate), (a)(6)(v), (vi), allowed in the Order with isocyanate
prevent exposure, where feasible, (b)(concentration set 0.1 percent), and residuals not greater than 0.1 percent by
(b)(concentration set 0.1 percent), and (c). weight or volume). It is a significant
(c). (ii) Hazard communication. new use to process or use the chemical
(ii) Hazard communication. Requirements as specified in § 721.72(a) substance other than for commercial use
Requirements as specified in § 721.72(a) through (e)(concentration set 0.1 but without any use in a consumer
through (e)(concentration set 0.1 percent), (f), (g)(1)(i), (ii), (g)(2)(i), (ii), setting. It is a significant new use to
percent), (f), (g)(1)(i), (ii), (iv), (vi), (vii), (v), (g)(3)(i), (ii), and (g)(5). Alternative modify the manufacture, process or use
(ix), (skin, eye, and mucous membrane hazard and warning statements that activities if it results in inhalation
irritation), (g)(2)(i), (ii), (iii), (v), (g)(3)(i), meet the criteria of the Globally exposure to vapor, dust, mist or aerosols
(ii), (g)(4)(i), (ii), (iii) and (g)(5). Harmonized System (GHS) and OSHA to the substance. It is a significant new
Alternative hazard and warning Hazard Communication Standard may use to import the chemical substance
statements that meet the criteria of the be used. containing greater than 0.15 percent
Globally Harmonized System (GHS) and (iii) Industrial, commercial, and residual isocyanate.
OSHA Hazard Communication Standard consumer activities. Requirements as (ii) [Reserved]
may be used. specified in § 721.80(f), (k)(dispersive (b) Specific requirements. The
(iii) Industrial, commercial, and additive for pigments in industrial provisions of subpart A of this part
consumer activities. Requirements as paints and coatings) and (q). It is a apply to this section except as modified
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specified in § 721.80(f), (k), and (t). significant new use to process or use the by this paragraph.
(iv) Release to water. Requirements as substance in a paint or coating (1) Recordkeeping. Recordkeeping
specified in § 721.90(a)(1), (b)(1), and formulation greater than 1 percent by requirements as specified in
(c)(1). weight or volume. It is a significant new § 721.125(a), (b), (c), and (i) are
(b) Specific requirements. The use to process or use the substance applicable to manufacturers and
provisions of subpart A of this part resulting in inhalation exposure to a processors of this substance.
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![Federal Register / Vol. 83, No. 166 / Monday, August 27, 2018 / Rules and Regulations 43555
(2) Limitations or revocation of requirements of this section do not significant new uses described in
certain notification requirements. The apply to quantities of the substance after paragraph (a)(2) of this section. The
provisions of § 721.185 apply to this they have been reacted (cured). requirements of this section do not
section. (2) The significant new uses are: apply to quantities of the substance after
(3) Determining whether a specific use (i) Protection in the workplace. they have been reacted (cured).
is subject to this section. The provisions Requirements as specified in (2) The significant new uses are:
of § 721.1725(b)(1) apply to paragraph § 721.63(a)(1), (a)(2)(i), (ii), (iii), (a)(3), (i) Protection in the workplace.
(a)(2)(i) of this section. when determining which persons are Requirements as specified in
■ 19. Add § 721.11112 to subpart E to reasonably likely to be exposed as § 721.63(a)(1), (a)(2)(i), (ii), (iii), (a)(3),
read as follows: required for § 721.63(a)(1) engineering when determining which persons are
control measures (e.g., enclosure or reasonably likely to be exposed as
§ 721.11112 Fatty acids, polymers with confinement of the operation, general required for § 721.63(a)(1) engineering
benzoic acid, cyclohexanedicarboxylic acid and local ventilation) or administrative control measures (e.g., enclosure or
anhydride, aliphatic diisocyanate, alkyl diol, control measures (e.g., workplace confinement of the operation, general
alkyl triol, pentaerythritol, phthalic policies and procedures) shall be and local ventilation) or administrative
anhydride, polyalkylene glycol amine, and
aromatic dicarboxylate sulfonic acid
considered and implemented to prevent control measures (e.g., workplace
sodium salt (generic). exposure, where feasible, policies and procedures) shall be
(b)(concentration set 1.0 percent), and considered and implemented to prevent
(a) Chemical substance and
(c). exposure, where feasible,
significant new uses subject to reporting. (ii) Hazard communication. (b)(concentration set 1.0 percent), and
(1) The chemical substance identified Requirements as specified in § 721.72(a) (c).
generically as fatty acids, polymers with through (e)(concentration set 1.0 (ii) Hazard communication.
benzoic acid, cyclohexanedicarboxylic percent), (f), (g)(1)(irritation), Requirements as specified in § 721.72(a)
acid anhydride, aliphatic diisocyanate, (sensitization), (g)(1)(iv), (vi), (ix), through (e)(concentration set 1.0
alkyl diol, alkyl triol, pentaerythritol, (g)(2)(i), (ii), (iii), (v), (g)(3)(i), (ii), percent), (f), (g)(1)(irritation),
phthalic anhydride, polyalkylene glycol (g)(4)(iii), and (g)(5). Alternative hazard (sensitization), (g)(1)(iv), (vi), (ix),
amine, and aromatic dicarboxylate and warning statements that meet the (g)(2)(i), (ii),)(iii), (v), (g)(3)(i), (ii),
sulfonic acid sodium salt (PMN P–17– criteria of the Globally Harmonized (g)(4)(iii), and (g)(5). Alternative hazard
231) is subject to reporting under this System (GHS) and OSHA Hazard and warning statements that meet the
section for the significant new uses Communication Standard may be used. criteria of the Globally Harmonized
described in paragraph (a)(2) of this (iii) Industrial, commercial, and System (GHS) and OSHA Hazard
section. The requirements of this section consumer activities. Requirements as Communication Standard may be used.
do not apply to quantities of the specified in § 721.80(f), (g) and (q). It is (iii) Industrial, commercial, and
substance after they have been reacted a significant new use to modify the consumer activities. Requirements as
(cured). manufacture, process or use activities if specified in § 721.80(f), (g) and (q). It is
(2) The significant new uses are: it results in inhalation exposure to a significant new use to modify the
(i) Industrial, commercial, and vapor, dust, mist or aerosols to the manufacture, process or use activities if
consumer activities. Requirements as substance. it results in inhalation exposure to
specified in § 721.80. It is a significant (iv) Release to water. Requirements as vapor, dust, mist or aerosols to the
new use to manufacture the chemical specified in § 721.90(a)(1), (b)(1), and substance.
substance containing greater than 0.1 (c)(1). (iv) Release to water. Requirements as
percent residual isocyanate. (b) Specific requirements. The specified in § 721.90(a)(1), (b)(1), and
(ii) [Reserved] provisions of subpart A of this part (c)(1).
(b) Specific requirements. The apply to this section except as modified (b) Specific requirements. The
provisions of subpart A of this part by this paragraph. provisions of subpart A of this part
apply to this section except as modified (1) Recordkeeping. Recordkeeping apply to this section except as modified
by this paragraph. requirements as specified in by this paragraph.
(1) Recordkeeping. Recordkeeping § 721.125(a) through (i) and (k) are (1) Recordkeeping. Recordkeeping
requirements as specified in applicable to manufacturers and requirements as specified in
§ 721.125(a), (b), (c), and (i) are processors of this substance. § 721.125(a) through (i) and (k) are
applicable to manufacturers and (2) Limitations or revocation of applicable to manufacturers and
processors of this substance. certain notification requirements. The processors of this substance.
(2) Limitations or revocation of provisions of § 721.185 apply to this (2) Limitations or revocation of
certain notification requirements. The section. certain notification requirements. The
provisions of § 721.185 apply to this (3) Determining whether a specific use provisions of § 721.185 apply to this
section. is subject to this section. The provisions section.
■ 20. Add § 721.11113 to subpart E to of § 721.1725(b)(1) apply to paragraph (3) Determining whether a specific use
read as follows: (a)(2)(iii) of this section. is subject to this section. The provisions
■ 21. Add § 721.11114 to subpart E to of § 721.1725(b)(1) apply to paragraph
§ 721.11113 Branched alkyl (C = 17) (a)(2)(iii) of this section.
carboxylic acid (generic).
read as follows:
■ 22. Add § 721.11115 to subpart E to
(a) Chemical substance and § 721.11114 Branched alkyl (C = 18) read as follows:
significant new uses subject to reporting. alcohol (generic).
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(1) The chemical substance identified (a) Chemical substance and § 721.11115 Alkoxy silane modified
generically as branched alkyl (C = 17) significant new uses subject to reporting. butadiene styrene copolymer (generic).
carboxylic acid (PMN P–17–247) is (1) The chemical substance identified (a) Chemical substance and
subject to reporting under this section generically as branched alkyl (C = 18) significant new uses subject to reporting.
for the significant new uses described in alcohol (PMN P–17–248) is subject to (1) The chemical substance identified
paragraph (a)(2) of this section. The reporting under this section for the generically as alkoxy silane modified
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![43556 Federal Register / Vol. 83, No. 166 / Monday, August 27, 2018 / Rules and Regulations
butadiene styrene copolymer (PMN P– determines that the Media Bureau will with respect to full power, Class A, and
17–260) is subject to reporting under announce, pursuant to the requirements MVPD entities,1 we direct the Media
this section for the significant new uses in the Reimbursement Expansion Act, Bureau to engage a contractor to assist
described in paragraph (a)(2) of this when the reimbursement program for all in the reimbursement process and
section. The requirements of this section entities eligible for reimbursement administration of the Reimbursement
do not apply to quantities of the pursuant to the Spectrum Act and the Fund for LPTV/translator and FM
substance after they have been reacted Reimbursement Expansion Act will end. stations. We direct the Media Bureau to
(cured). Finally, the Commission interprets the engage a third-party contractor to assist
(2) The significant new uses are: Reimbursement Expansion Act as in the reimbursement process, which
(i) Industrial, commercial, and providing at least $50 million for use by will be overseen by the Bureau.
consumer activities. Requirements as the Commission to fund its efforts to 2. Reimbursement Process. We direct
specified in § 721.80(k). It is a educate consumers about the the Media Bureau to revise the forms to
significant new use to modify the reorganization of broadcast television be used by eligible LPTV/translator and
manufacture, process or use activities if spectrum under the United States Code. FM stations to claim reimbursement
it results in inhalation exposure to DATES: This action is effective August from the Reimbursement Fund and for
vapor, dust, mist or aerosols to the 27, 2018. any other Reimbursement Fund-related
substance. purposes. We also direct the Media
FOR FURTHER INFORMATION CONTACT:
(ii) [Reserved] Bureau to calculate the amount of the
(b) Specific requirements. The Maria Mullarkey, Maria.Mullarkey@
allocations to eligible entities from the
provisions of subpart A of this part fcc.gov, of the Media Bureau, Policy
Reimbursement Fund, develop a revised
apply to this section except as modified Division, (202) 418–2120. For additional
Catalog of Eligible Expenses, and make
by this paragraph. information concerning the Paperwork
other determinations regarding eligible
(1) Recordkeeping. Recordkeeping Reduction Act information collection
costs and the reimbursement process.
requirements as specified in requirements contained in this
Finally, we direct the Media Bureau to
§ 721.125(a), (b), (c), and (i) are document, contact Cathy Williams at
implement the necessary policies and
applicable to manufacturers and (202) 418–2918 or send an email to
procedures relating to eligibility
processors of this substance. PRA@fcc.gov.
certifications, allocations, draw downs,
(2) Limitations or revocation of SUPPLEMENTARY INFORMATION: This is a payments, obligations, and expenditures
certain notification requirements. The summary of the Commission’s Order, of money from the Reimbursement Fund
provisions of § 721.185 apply to this FCC 18–113, adopted on August 2, in order to protect against waste, fraud,
section. 2018, and released on August 3, 2018. and abuse and in the event of
(3) Determining whether a specific use The full text of this document is bankruptcy. Given the importance of
is subject to this section. The provisions available electronically via the FCC’s maintaining the integrity of the Fund,
of § 721.1725(b)(1) apply to paragraph Electronic Document Management the Media Bureau will consult with the
(a)(2)(i) of this section. System (EDOCS) website at http:// Office of General Counsel and the Office
[FR Doc. 2018–18403 Filed 8–24–18; 8:45 am] fjallfoss.fcc.gov/edocs_public/ or via the of the Managing Director in acting
BILLING CODE 6560–50–P
FCC’s Electronic Comment Filing pursuant to this direction.
System (ECFS) website at http:// 3. Reimbursement Period. The
fjallfoss.fcc.gov/ecfs2/. Documents will Reimbursement Expansion Act 2
be available electronically in ASCII, provides that the Commission must
FEDERAL COMMUNICATIONS
Microsoft Word, and/or Adobe Acrobat. make all reimbursements using the
COMMISSION
This document is also available for additional funds appropriated by the
47 CFR Part 73 public inspection and copying during Reimbursement Expansion Act to the
regular business hours in the FCC Reimbursement Fund by July 3, 2023.3
[MB Docket Nos. 18–214, 12–268; FCC 18– Reference Information Center, Federal
113] With respect to LPTV/translators and
Communications Commission, 445 12th FM stations, we authorize the Media
LPTV, TV Translator, and FM Street SW, CY–A257, Washington, DC Bureau to announce, in one or more
Broadcast Station Reimbursement; 20554. Alternative formats are available public notices to be issued following the
Expanding the Economic and for people with disabilities (Braille,
Innovation Opportunities of Spectrum large print, electronic files, audio 1 See Expanding the Economic and Innovation
Through Incentive Auctions format), by sending an email to fcc504@ Opportunities of Spectrum Through Incentive
fcc.gov or calling the Commission’s Auctions, Report and Order, 29 FCC Rcd 6567,
6820, paras. 618–19 (2014), 79 FR 48442 (Aug. 15,
AGENCY: Federal Communications Consumer and Governmental Affairs 2014), (Incentive Auction R&O).
Commission. Bureau at (202) 418–0530 (voice), (202) 2 See Consolidated Appropriations Act, 2018,
ACTION: Final action. 418–0432 (TTY). Public Law 115–141, at Division E, Title V, sec. 511,
The Order does not contain new or 132 Stat. 348 (2018) (codified at 47 U.S.C. 1452(j)–
SUMMARY: In this document, the modified information collection (n)).
3 See 47 U.S.C. 1452(j)(3)(B). Section 511(j)(3)(C)
Commission directs the Media Bureau requirements subject to the Paperwork provides that, if all reimbursements pursuant to the
to engage a contractor to assist in the Reduction Act of 1995. In addition, Spectrum Act and the Reimbursement Expansion
reimbursement process and therefore, it does not contain any new Act have been made before July 3, 2023, ‘‘the
administration of the Reimbursement or modified information collection Commission shall submit to the Secretary of the
Fund for LPTV, TV translator, and FM Treasury a certification that all such
burdens for small business concerns reimbursements have been made.’’ Id. sec.
stations, and also directs the Bureau to with fewer than 25 employees, pursuant
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1452(j)(3)(C). In addition, the Reimbursement
make determinations regarding eligible to the Small Business Paperwork Relief Expansion Act provides that reimbursement
costs and the reimbursement process, Act of 2002. payments to LPTV/translator and FM stations may
such as calculating the amount of not be made after April 13, 2020 unless the
allocations to eligible entities and I. Order Commission ‘‘submits to Congress a certification
that such payments are necessary to reimburse costs
seeking comment on a revised Catalog of 1. Reimbursement Contractor. Similar reasonably incurred’’ by such stations. See id. sec.
Eligible Expenses. The Commission also to the approach the Commission took 1452(j)(2)(C)(ii), (iii).
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Document Created: 2018-08-25 01:47:56
Document Modified: 2018-08-25 01:47:56
| 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 October 26, 2018. For purposes of judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on September 10, 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, | |
| FR Citation | 83 FR 43538 | |
| 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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