Significant New Use Rules on Certain Chemical Substances, 37702-37733 [2018-15995]

Download as PDF 37702 Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Rules and Regulations ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 9 and 721 [EPA–HQ–OPPT–2017–0366; FRL–9970–23] RIN 2070–AB27 Significant New Use Rules on Certain Chemical Substances Environmental Protection Agency (EPA). ACTION: Direct final rule. AGENCY: EPA is promulgating significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for 145 chemical substances which were the subject of premanufacture notices (PMNs). The chemical substances are subject to consent 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 145 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 1, 2018. For purposes of judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on August 15, 2018. Written adverse comments on one or more of these SNURs must be received on or before August 31, 2018 (see Unit VI. of the SUPPLEMENTARY INFORMATION). If EPA receives written adverse comments on one or more of these SNURs before August 31, 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–2017–0366, 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) sradovich on DSK3GMQ082PROD with RULES2 SUMMARY: VerDate Sep<11>2014 21:28 Jul 31, 2018 Jkt 244001 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: moss.kenneth@epa.gov. For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554– 1404; email address: TSCA-Hotline@ epa.gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this action apply to me? You may be potentially affected by this action if you manufacture, process, or use the chemical substances contained in this 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 PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 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 August 31, 2018 are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see § 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D. B. What should I consider as I prepare my comments for EPA? 1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD–ROM that you mail to EPA, mark the outside of the disk or CD–ROM as CBI and then identify electronically within the disk or CD–ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. 2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at http://www.epa.gov/dockets/ comments.html. II. Background A. What action is the Agency taking? 1. Direct Final Rule. EPA is promulgating these SNURs using direct final 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 August 31, 2018 (see Unit VI. of the SUPPLEMENTARY INFORMATION), the E:\FR\FM\01AUR2.SGM 01AUR2 Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Rules and Regulations 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. sradovich on DSK3GMQ082PROD with RULES2 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 § 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 VerDate Sep<11>2014 21:28 Jul 31, 2018 Jkt 244001 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 145 chemical substances in 40 CFR part 721, subpart E. In this unit, EPA provides the following information for each chemical substance: • PMN number. • Chemical name (generic name, if the specific name is claimed as CBI). • Chemical Abstracts Service (CAS) Registry number (if assigned for nonconfidential chemical identities). • Basis for the TSCA section 5(e) consent 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 PO 00000 Frm 00003 Fmt 4701 Sfmt 4700 37703 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 highthroughput screening methods and their prediction models. EPA also recognizes that whether testing/further information is needed will depend on the specific exposure and use scenario in the SNUN. EPA encourages all SNUN submitters to contact EPA to discuss any potential future testing. See Unit VIII. for more information. • CFR citation assigned in the regulatory text section of this rule. The regulatory text section of each rule specifies the activities designated as significant new uses. Certain new uses, including exceedance of production volume limits (i.e., limits on manufacture volume) and other uses designated in this rule, may be claimed as CBI. Unit IX. discusses a procedure companies may use to ascertain whether a proposed use constitutes a significant new use. These rules include 145 PMN substances that are subject to Orders under TSCA section 5(e)(1)(A)(ii)(I) where EPA determined that 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 E:\FR\FM\01AUR2.SGM 01AUR2 37704 Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Rules and Regulations sradovich on DSK3GMQ082PROD with RULES2 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 § 721.63 respirator requirements may request to do so under § 721.30. EPA expects that persons whose § 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 Numbers: P–14–472 and P–14–496 Chemical names: Polyphosphoric acids, 2-[alkyl-1-oxo-2-propen-1yl)oxy]ethyl esters, compds. with N(aminoiminomethyl)urea (generic) (P– 14–472) and Polyphosphoric acids, 2[(2-methyl-1-oxo-2-propen-1yl)oxy]ethyl esters, compds. with alkyl amino, polymers with Bu acrylate, N(hydroxymethyl)propenamide and styrene (generic) (P–14–496). CAS numbers: Not available. Effective date of TSCA section 5(e) Order: April 26, 2017. Basis for TSCA section 5(e) Order: The PMN states that the generic (nonconfidential) uses of the PMN substances are as a site-controlled intermediate (P–14–472) and a paper additive (P–14–496). Based on Structure Activity Relationship (SAR) analysis of test data on acrylates/methacrylates, and other structurally similar substances, there is potential for irritation and sensitization for P–14–472. For P–14– 496 there is concern for sensitization based on the presence of formaldehyde and concern for irritation and lung effects from the surfactant properties of the substance. Further, based on SAR analysis of test data on analogous phosphates, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 3 parts per billion (ppb) of P–14–472 and 4 ppb of P–14–496 in surface waters. The Order was issued under TSCA sections 5(a)(3)(B)(i) and 5(e)(1)(A)(i), based on a finding that the available information is insufficient to permit a reasoned VerDate Sep<11>2014 21:28 Jul 31, 2018 Jkt 244001 evaluation of the human health effects of the PMN substances. Further, 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 human health and the environment. To protect against these risks, the Order requires: 1. Submission of certain toxicity testing on the PMN substances prior to exceeding the confidential production volume limit as specified in the Order. 2. Use of personal protective equipment to prevent dermal exposure. 3. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the Safety Data Sheet (SDS). 4. No release of the PMN substances resulting in surface water concentrations that exceed 3 ppb for P– 14–472 and 4 ppb for P–14–496. 5. No modification of the manufacturing process that results in inhalation exposure and no use involving application methods that generate a dust, mist, or aerosol. 6. Use of the PMN substances only as a site-limited intermediate (P–14–472) and the confidential use specified in the Order (P–14–496). The SNUR would designate as a ‘‘significant new use’’ the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the fate and human health toxicity of the PMN substances may be potentially useful to characterize the effects of the PMN substances in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. The submitter has agreed not to exceed the confidential production limit without performing a skin sensitization study and a biodegradation test on each substance. In addition, EPA has determined that the results of a pulmonary effects testing of the PMN substance may be potentially useful in characterizing the 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, 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. PO 00000 Frm 00004 Fmt 4701 Sfmt 4700 CFR citations: 40 CFR 721.11024 (P– 14–472) and 40 CFR 721.11025 (P–14– 496). PMN Number: P–14–630 Chemical name: Bismuth bromide iodide oxide. CAS number: 340181–06–8. Effective date of TSCA section 5(e) Order: May 10, 2017. Basis for TSCA section 5(e) Order: The PMN states that the substance will be used as a pigment for liquid coatings solvent based system; a pigment for powder coatings; and a pigment for polymer materials. Based on test data and physical/chemical properties of the PMN substance, as well as SAR analysis of analogous respirable, poorly soluble particulates, EPA identified concerns for lung effects, including fibrosis. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on insufficient information to make a reasoned evaluation and a finding that the substance may present an unreasonable risk of injury to human health. EPA assessed risks based on the specific manufacturing, processing, use, distribution/transportation, treatment and disposal processes, process equipment, engineering controls, and handling practices (including worker activities and cleaning procedures) described in the PMN. To protect against these risks, the Order requires: 1. Submission of certain toxicity testing on the PMN substance prior to exceeding the confidential production volume limit as specified in the Order. 2. Use of a National Institute for Occupational Safety and Health (NIOSH)-certified respirator with an Assigned Protection Factor (APF) of at least 10 (where there is a potential for inhalation exposures) or compliance with a New Chemical Exposure Limit (NCEL) of 2.4 milligram/meter3 (mg/m3) as an 8-hour time-weighted average. 3. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS. 4. No use of the substance in a consumer product that generates a dust, mist, or aerosol. The SNUR will designate as a ‘‘significant new use’’ the absence of these protective measures, and any use to vary or alter, the manufacturing, processing, use, distribution/ transportation, treatment and disposal processes, process equipment, engineering controls, and handling practices (including worker activities and cleaning procedures) described in the PMN in such a way as to change the magnitude of inhalation exposure. E:\FR\FM\01AUR2.SGM 01AUR2 Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Rules and Regulations Potentially useful information: EPA has determined that certain information about the human health toxicity of the PMN substance may be potentially useful to characterize the effects of the PMN substance 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 target organ toxicity testing. In addition, EPA has determined that the results of a chronic toxicity/ carcinogenicity test 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, 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 721.11026. sradovich on DSK3GMQ082PROD with RULES2 PMN Number: P–15–450 Chemical name: Aluminum cobalt lithium nickel oxide. CAS number: 177997–13–6. Effective date of TSCA section 5(e) Order: March 23, 2017. Basis for TSCA section 5(e) Order: The PMN states that the substance will be used as a mixed metal oxide for batteries. Based on test data on the PMN substance, EPA identified concerns for spleen and kidney toxicity. Based on physical/chemical properties of the PMN substance, as well as SAR analysis of analogous respirable, poorly soluble particulates, EPA identified concerns for lung effects based on lung overload. Based on the crystalline structure of the PMN substance, EPA identified concern for lung carcinogenicity. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on insufficient information to make a reasoned evaluation and a finding that the substance may present an unreasonable risk of injury to human health. EPA assessed risks based on the specific manufacturing, processing, use, distribution/transportation, treatment and disposal processes, process equipment, engineering controls, and handling practices (including worker activities and cleaning procedures) described in the PMN. To protect against these risks, the Order requires: 1. Submission of certain toxicity testing on the PMN substance prior to VerDate Sep<11>2014 21:28 Jul 31, 2018 Jkt 244001 exceeding the time limit as specified in the Order. 2. Use of personal protective equipment including impervious gloves and protective clothing (where there is a potential for dermal exposures). 3. Use of a NIOSH-certified respirator with an APF of at least 1,000 (where there is a potential for inhalation exposure) or compliance with a NCEL of 0.000092 ppm as an 8-hour timeweighted average. 4. Use of the chemical transfer processes and air ventilation processes described in the PMN and the exposure monitoring requirements described in the Order. 5. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS. 6. Disposal of the PMN substance by landfill only. Air releases are limited by processes described in the PMN, including filtering through a highefficiency particulate air filter with an efficiency rate of 99.99%. 7. No domestic manufacture of the PMN substance. The SNUR will designate as a ‘‘significant new use’’ the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the human health toxicity of the PMN substance may be potentially useful to characterize the effects of the PMN substance 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 time limit without performing specific target organ toxicity testing and carcinogenicity testing. In addition, EPA has determined that the results of medical monitoring of the workers exposed to the substance during manufacturing, processing, and use may be potentially useful in characterizing the health effects of the PMN substance. Although the Order does not require this medical monitoring, the Order’s restrictions on manufacture, processing, 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 721.11027. PMN Number: P–15–705 Chemical name: Alkylarylamine (generic). CAS number: Not available. PO 00000 Frm 00005 Fmt 4701 Sfmt 4700 37705 Effective date of TSCA section 5(e) Order: May 11, 2017. Basis for TSCA section 5(e) Order: The PMN states that the substance will be used as a chemical intermediate and as an additive and octane booster in aviation fuels. Based on test data on the PMN substance, EPA has identified concerns for dermal irritation, developmental toxicity, and blood effects. Based on test data on analogous anilines, EPA has identified concerns for cardiovascular, eye, liver, kidney, and pulmonary effects, as well as bladder cancer. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on insufficient information to make a reasoned evaluation and a finding that the substance may present an unreasonable risk of injury to human health. To protect against these risks, the Order requires: 1. Submission of certain toxicity testing on the PMN substance prior to exceeding the confidential production volume limit as specified in the Order. 2. Use of personal protective equipment including impervious gloves, full body chemical protective clothing and chemical goggles or equivalent eye protection (where there is a potential for dermal exposure). 3. Use of a NIOSH-certified respirator with an APF of at least 1,000 (where there is a potential for inhalation exposure) or compliance with a NCEL of 0.48 mg/m3 as an 8-hour time-weighted average. (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. No use of the substance in a consumer product. 5. No use other than as a chemical intermediate or as an additive and octane booster in aviation fuels. 6. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS. 7. No release of the PMN substance resulting in surface water concentrations that exceed 1 ppb. The SNUR will designate as a ‘‘significant new use’’ the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the human health and aquatic 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 E:\FR\FM\01AUR2.SGM 01AUR2 37706 Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Rules and Regulations 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 target organ toxicity testing and a chronic aquatic toxicity test. CFR citation: 40 CFR 721.11028. sradovich on DSK3GMQ082PROD with RULES2 PMN Numbers: P–15–706 and P–15–707 Chemical names: Aliphatic N-alkyl urea polymer containing cyclohexyl groups and trimethoxy silanes (generic) (P–15–706) and Aliphatic N-alkyl urea polymer containing aspartic ester groups and trimethoxy silanes (generic) (P–15–707). CAS numbers: Not available. Effective date of TSCA section 5(e) Order: April 26, 2017. Basis for TSCA section 5(e) Order: The PMNs state that the generic use of the substances will be as ingredients for multipurpose exterior coatings. Based on SAR analysis on reactive methoxy silane moieties, EPA has identified concerns for irritation to lungs, eyes, and mucus membranes. There are also concerns for acute toxicity, neurotoxicity, and developmental toxicity based on the presence of methanol, and for sensitization if there are residual isocyanates. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on insufficient information to make a reasoned evaluation and a finding that the substances may present an unreasonable risk of injury to human health. To protect against these risks, the Order requires: 1. Submission of certain toxicity testing on the PMN substance prior to exceeding the production limit as specified in the Order. 2. Use of personal protective equipment including impervious gloves (where there is a potential for dermal exposure). 3. Use of a NIOSH-certified respirator with an APF of at least 10 (where there is a potential for inhalation exposure) or compliance with a NCEL of 0.9 mg/m3 as an 8-hour time-weighted average. (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 human health precautionary statements on each label and in the SDS. 5. No manufacture beyond an annual production volume of 250,000 kilograms (kg). VerDate Sep<11>2014 21:28 Jul 31, 2018 Jkt 244001 6. Manufacture of the PMN substances to contain no more than 0.1% residual isocyanate by weight. 7. No uses of the substances other than allowed in the Order. 8. No use of the substances in a consumer product. The SNUR will designate as a ‘‘significant new use’’ the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the human health toxicity of the PMN substances may be potentially useful to characterize the effects of the PMN substances in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. The submitter has agreed not to exceed the confidential production limit without performing specific target organ toxicity testing for P–15–706. CFR citation: 40 CFR 721.11029 (P– 15–706) and 40 CFR 721.11030 (P–15– 707). PMN Numbers: P–16–273 and P–16–274 Chemical names: Alkyl heteromonocycle, polymer with heteromonocycle, carboxyalkyl alkyl ethers (generic). CAS numbers: Not available. Effective date of TSCA section 5(e) Order: April 25, 2017. Basis for TSCA section 5(e) Order: The PMNs state that the generic (nonconfidential) use of the substances will be as ingredients in metalworking fluids. Based on submitted test data for P–16–273 and structurally similar surfactants, EPA has identified concerns for dermal sensitization and irritation and lung effects. Based on submitted toxicity data for P–16–273, EPA estimates toxicity to aquatic organisms may occur for both PMNs at concentrations that exceed 10 ppb of the PMN substances 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 insufficient information to make a reasoned evaluation and a finding that the substances may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires: 1. No domestic manufacture of the PMN substances. 2. Use of the PMN substances only: (i) For the confidential uses specified in the Order, (ii) at a concentration no greater than 3% of the metalworking fluid, and (iii) used only in closed metalworking systems as specified in the PMNs with no modifications in the PO 00000 Frm 00006 Fmt 4701 Sfmt 4700 process that would result in worker inhalation exposure. 3. Use of personal protective equipment including impervious gloves (where there is a potential for dermal exposure). 4. No release of the PMN substances resulting in surface water concentrations that exceed 10 ppb. The SNUR will designate as a ‘‘significant new use’’ the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the fate and toxicity of the PMN substances may be potentially useful to characterize the health and environmental effects of the PMN substances in support of a request by the PMN submitter to modify the 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 biodegradation test of the PMN substances may be potentially useful in characterizing the health and environmental effects of the PMN substances. Although the Order does not require these tests, the Order’s restrictions on manufacture, processing, 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 721.11031. PMN Number: P–16–289 Chemical name: Benzene dicarboxylic acid, polymer with alkane dioic acid and aliphatic diamine (generic). CAS number: Not available. Effective date of TSCA section 5(e) Order: March 24, 2017. Basis for TSCA section 5(e) Order: The PMN states the substance will be used as an extrusion compounding molding resin. Based on test data on analogous high molecular weight polymers, EPA has concerns for lung effects, which includes lung overload. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on insufficient information to make a reasoned evaluation and a finding that the substance may present an unreasonable risk of injury to human health. To protect against these risks, the Order requires: 1. Submission of particle size testing on the PMN substance prior to exceeding the time limit as specified in the Order. E:\FR\FM\01AUR2.SGM 01AUR2 Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Rules and Regulations 2. Manufacture of the PMN substance such that the solid particle form has a particle size distribution where less than 1% of the particles are less than 10 microns. The SNUR will designate as a ‘‘significant new use’’ the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the physical/chemical characteristics 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 manufacture beyond a certain time period without measuring the particle size distribution to characterize the fraction of the dry particle PMN substance less than 10 microns. In addition, EPA has determined that the results of specific target organ toxicity testing 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, 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 721.11032. sradovich on DSK3GMQ082PROD with RULES2 PMN Number: P–16–322 Chemical name: Manganese cyclic (tri)amine chloride complex (generic). CAS number: Not available. Effective date of TSCA section 5(e) Order: April 25, 2017. Basis for TSCA section 5(e) Order: The PMN states that the generic (nonconfidential) use of the substance will be as a pulp bleaching catalyst. Based on test data on an analog, EPA has identified concerns for kidney, blood, and thyroid effects, immunotoxicity, reproductive and developmental toxicity, and neurotoxicity. Based on test data on the PMN substance, EPA estimates that toxicity to aquatic organisms may occur at concentrations that exceed 18 ppb of the PMN substance 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 insufficient information to make a reasoned evaluation and a finding that the substance may present an unreasonable risk of injury to human VerDate Sep<11>2014 21:28 Jul 31, 2018 Jkt 244001 health and the environment. To protect against these risks, the Order requires: 1. Submission of certain toxicity testing on the PMN substance prior to exceeding the confidential production volume limit as 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 NIOSH-certified respirator with an APF of at least 25 (where there is a potential for inhalation exposure) or compliance with a NCEL of 1.2 ppm as an 8-hour time-weighted average. (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 human health precautionary statements on each label and in the SDS. 5. No domestic manufacture of the PMN substance. 6. Process and use of the PMN substance only for the confidential uses and formulation percentage specified in the Order. 7. No release of the PMN substance resulting in surface water concentrations that exceed 18 ppb. The SNUR will designate as a ‘‘significant new use’’ the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the human health and aquatic 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 target organ toxicity testing, reproductive/developmental toxicity testing; and chronic aquatic toxicity testing. CFR citation: 40 CFR 721.11033. PMN Numbers: P–16–338, P–16–339, P–16–439, and P–16–440 Chemical names: Xanthylium, (sulfoaryl)-bis [(substituted aryl) amino]-, sulfo derivs., inner salts, metal salts (generic) (P–16–338); Substituted triazinyl metal salt, diazotized, coupled with substituted pyridobenzimidazolesulfonic acids, substituted pyridobenzimidazolesulfonic acids, diazotized substituted alkanesulfonic PO 00000 Frm 00007 Fmt 4701 Sfmt 4700 37707 acid, diazotized substituted aromatic sulfonate, diazotized substituted aromatic sulfonate, metal salts (generic) (P–16–339); Carbon black, (organic acidic carbocyclic)-modified, inorganic salt (generic) (P–16–439); and Carbon black, (organic acidic carbocyclic)modified, metal salt (generic) (P–16– 440). CAS numbers: Not available. Effective date of TSCA section 5(e) Order: April 11, 2017. Basis for TSCA section 5(e) Order: The PMN states that the generic (nonconfidential) uses of the PMN substances will be as dyestuffs (P–16– 0338 and P–16–0339) and as coloring agents (P–16–0439 and P–16–0440). Based on physical/chemical properties of the PMN substances and test data on analogous poorly respirable particles, EPA has identified concerns for irritation to the eyes, lungs, and mucous membranes, and lung effects. Further, based on SAR analysis of test data on analogous dyes, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 200 ppb of the PMN substances 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 insufficient information to make a reasoned evaluation and a finding that the substances may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires: 1. No manufacture of the PMN substances beyond the confidential annual production volume specified in the Order. 2. No domestic manufacture of the PMN substances. 3. Import the PMN substances only according to the terms specified and for the confidential uses specified in the Order. 4. No release of the PMN substances to surface waters. The SNUR will designate as a ‘‘significant new use’’ the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the fate, human health toxicity, and aquatic toxicity of the PMN substances may be potentially useful to characterize the effects of the PMN substances in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of a biodegradation test, specific target organ toxicity testing, and acute and chronic aquatic toxicity testing of the PMN E:\FR\FM\01AUR2.SGM 01AUR2 37708 Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Rules and Regulations sradovich on DSK3GMQ082PROD with RULES2 substances may be potentially useful in characterizing the health and environmental effects of the PMN substances. Although the Order does not require these tests, the Order’s restrictions on manufacture, processing, 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 citations: 40 CFR 721.11034 (P– 16–338), 40 CFR 721.11035 (P–16–339), 40 CFR 721.11036 (P–16–439), and 40 CFR 721.11037 (P–16–440). PMN Number: P–16–350 Chemical name: Polyaralkyl aryl ester of methacrylic acid (generic). CAS number: Not available. Effective date of TSCA section 5(e) Order: March 31, 2017. Basis for TSCA section 5(e) Order: The PMN states that the generic (nonconfidential) use of the substance will be as a polymer reactant. Based on test data on methacrylate moieties, EPA has identified concerns for irritation and sensitization based on analogy to methacrylates. Based on SAR analysis of test data on structurally similar respirable surfactants, EPA has identified concerns for lung effects. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on insufficient information to make a reasoned evaluation and a finding that the substance may present an unreasonable risk of injury to human health. To protect against these risks, the Order requires: 1. Use of personal protective equipment including impervious gloves (where there is a potential for dermal exposure). 2. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS. 3. Manufacture of the PMN substance such that it is not less than the minimum average molecular weight identified in the Order and does not contain more than the maximum weight percent of low molecular weight species below 1,000 Daltons. 4. Use of the PMN substance only for the confidential use specified in the Order. The SNUR will designate as a ‘‘significant new use’’ the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the toxicity of the PMN substance may be potentially useful to characterize the health effects of the PMN substance VerDate Sep<11>2014 21:28 Jul 31, 2018 Jkt 244001 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, 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 721.11038. PMN Number: P–16–352 Chemical names: Phenol, 2-[[[3(octyloxy)propyl]imino]methyl]- (P–16– 352, chemical A) and Phenol, 2-[[[3(decyloxy)propyl]imino]methyl]- (P–16– 352, chemical B). CAS numbers: 1858221–49–4 (P–16– 352, chemical A) and 1858221–50–7 (P– 16–352, chemical B). Effective date of TSCA section 5(e) Order: April 21, 2017. Basis for TSCA section 5(e) Order: The PMN states that the PMN substances will be used as co-catalysts in the manufacturing of release coatings for producing papers and films at a concentration of 1% or less. Based on SAR analysis of test data on analogous phenols, EPA has identified concerns for respiratory and dermal irritation and developmental toxicity. In addition, EPA has identified concerns for liver toxicity and reproductive effects based on the hydrolysis product ohydroxybenzaldehyde. Further, based on SAR analysis of test data on analogous phenols, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substances 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 insufficient information to make a reasoned evaluation and a finding that the substances may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires: 1. Submission of certain toxicity testing on the PMN substance prior to exceeding the confidential production volume limit as specified in the Order. 2. Use of personal protective equipment including impervious gloves PO 00000 Frm 00008 Fmt 4701 Sfmt 4700 (where there is a potential for dermal exposure). 3. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS. 4. No domestic manufacture of the PMN substances. 5. No manufacture of the PMN substances beyond an annual production volume of 250 kg/yr. 6. No use of the PMN substances in application methods that generate a dust, mist, or aerosol. 7. No release of the PMN substance resulting in surface water concentrations that exceed 1 ppb. The SNUR will designate as a ‘‘significant new use’’ the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the human health and aquatic 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 target organ toxicity, reproductive/developmental toxicity, and acute aquatic toxicity testing. CFR citations: 40 CFR 721.11039 (P– 16–352, chemical A) and 40 CFR 721.11040 (P–16–352, chemical B). PMN Number: P–16–358 Chemical name: Alkyl phenol (generic). CAS number: Not available. Effective date of TSCA section 5(e) Order: April 24, 2017. Basis for TSCA section 5(e) Order: The PMN states that the substance will be used as a chemical intermediate. Based on SAR analysis of test data on analogous phenols, EPA has identified concerns for developmental toxicity. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on insufficient information to make a reasoned evaluation and a finding that the substance may present an unreasonable risk of injury to human health. To protect against these risks, the Order requires: 1. Submission of certain toxicity testing on the PMN substance prior to exceeding the confidential production volume limit as specified in the Order. 2. Use of personal protective equipment including impervious gloves (where there is a potential for dermal exposure). E:\FR\FM\01AUR2.SGM 01AUR2 Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Rules and Regulations sradovich on DSK3GMQ082PROD with RULES2 3. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS. 4. Use of the PMN substance only as a chemical intermediate. 5. No manufacture, process, or use of the PMN substance in any manner or method that generates a dust, mist, or aerosol or in a non-enclosed process. 6. No release of the PMN substance to surface waters. The SNUR will designate as a ‘‘significant new use’’ the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the human health toxicity of the PMN substance may be potentially useful to characterize the effects of the PMN substance 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 will be designated by this SNUR. The submitter has agreed not to exceed the confidential production limit without performing specific target organ toxicity and reproductive/developmental toxicity tests. CFR citation: 40 CFR 721.11041. PMN Number: P–16–364 Chemical name: Nitrile-butadieneacrylate terpolymers (generic). CAS number: Not available. Effective date of TSCA section 5(e) Order: March 31, 2017. Basis for TSCA section 5(e) Order: The PMN states that the generic (nonconfidential) use of the substance will be as a chemical intermediate. Based on SAR analysis of test data on structurally similar respirable particles, EPA has identified concerns for lung effects, including lung overload. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on insufficient information to make a reasoned evaluation and a finding that the substance may present an unreasonable risk of injury to human health. To protect against these risks, the Order requires: 1. Use of the PMN substance only as a site-limited chemical intermediate. 2. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS. 3. No manufacture, process, or use of the PMN substance if it contains more than 5% of the particle size distribution less than 10 microns. The SNUR will designate as a ‘‘significant new use’’ the absence of these protective measures. Potentially useful information: EPA has determined that certain information VerDate Sep<11>2014 21:28 Jul 31, 2018 Jkt 244001 about the 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. EPA has determined that the results of specific target organ toxicity testing of the PMN substance may be potentially useful in characterizing the health effects of the PMN substance. Although the Order does not require this test, the Order’s restrictions on manufacture, processing, 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 721.11042. PMN Number: P–16–399 Chemical name: Starch, polymer with 2-propenoic acid, potassium salt, oxidized. CAS number: 1638117–09–5. Effective date of TSCA section 5(e) Order: April 6, 2017. Basis for TSCA section 5(e) Order: The PMN states that the substance will be used as an agricultural soil amendment for field crops, agricultural soil amendment for turf applications and direct soil injection with fertilizers, and a compound to be used in preparation of advanced seed coatings. Based on SAR analysis of test data on structurally similar respirable particles, EPA has identified concerns for lung effects, including lung overload. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on insufficient information to make a reasoned evaluation and a finding that the substance may present an unreasonable risk of injury to human health. The Order was also issued under TSCA sections 5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II), based on a finding that the substance that the substance is or will be produced in substantial quantities and that the substance either enters or may reasonably be anticipated to enter the environment in substantial quantities, or there is or may be significant (or substantial) human exposure to the substance. To protect against these risks, the Order requires: 1. Submission of certain toxicity testing on the PMN substance prior to exceeding the time limit as specified in the Order. 2. Use of personal protective equipment including impervious gloves PO 00000 Frm 00009 Fmt 4701 Sfmt 4700 37709 (where there is a potential for dermal exposure). 3. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS. 4. Manufacture of the substance with a particulate size greater than 30 microns. The SNUR will designate as a ‘‘significant new use’’ the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the toxicity of the PMN substance may be potentially useful to characterize the health and environmental effects of the PMN substance 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 manufacture beyond a certain time limit without performing an acute aquatic toxicity test. In addition, EPA has determined that the results of specific target organ toxicity testing 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, 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 721.11043. PMN Number: P–16–430 Chemical name: Pentanedioic acid, 2methyl-. CAS number: 617–62–9. Effective date of TSCA section 5(e) Order: May 17, 2017. Basis for TSCA section 5(e) Order: The PMN states the generic (nonconfidential) use of the substance will be as a filler. Based on test data on the PMN substance, EPA has identified concerns for systemic and reproductive toxicity. Based on structural analysis on the acid groups and test data, EPA has identified concerns for dermal and respiratory irritation. Further, based on test data on the PMN substance and test data on analogous neutral organics, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 14 ppb of the PMN substance 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 insufficient information to make a reasoned evaluation and a finding that the E:\FR\FM\01AUR2.SGM 01AUR2 sradovich on DSK3GMQ082PROD with RULES2 37710 Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Rules and Regulations substance may present an unreasonable risk of injury to human health and the environment. EPA assessed risks based on the specific processing, use, distribution/transportation, treatment and disposal processes, process equipment, engineering controls, and handling practices (including worker activities and cleaning procedures) described in the PMN. To protect against these risks, the Order requires: 1. Use of personal protective equipment including impervious gloves (where there is a potential for dermal exposure). 2. Use of a NIOSH-certified respirator with an APF of at least 10 (where there is a potential for 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.) 3. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS. 4. No domestic manufacture of the PMN substance. 5. Import of the PMN substance at or below the maximum concentration specified in the Order. 6. No release of the PMN substance resulting in surface water concentrations that exceed 14 ppb. The SNUR will designate as a ‘‘significant new use’’ the absence of these protective measures, and use of the chemical substance to vary or alter the processing, use, distribution, engineering controls, and handling practices described in the Order in such a way as to change the magnitude of inhalation exposure. Potentially useful information: EPA has determined that certain information about the human health toxicity of the PMN substance may be potentially useful to characterize the effects of the 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 of the PMN substance may be potentially useful in characterizing the health effects of the PMN substance. Although the Order does not require this test, the Order’s restrictions on manufacture, processing, 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. CFR citation: 40 CFR 721.11044. VerDate Sep<11>2014 21:28 Jul 31, 2018 Jkt 244001 PMN Number: P–16–495 Chemical name: 2-Pentanol, 4-methyl-, reaction products with phosphorus oxide (P2O5), compounds with alkylamine (generic). CAS number: Not available. Effective date of TSCA section 5(e) Order: April 25, 2017. Basis for TSCA section 5(e) Order: The PMN states that the generic use (non-confidential) of the substance will be as a lubricant additive. Based on test data on the substance, EPA has identified concerns for systemic effects, sensitization and irritation to the eyes and skin. Based on physical/chemical properties, EPA has concerns for lung effects, including lung surfactancy. Further, based on test data on analogous aliphatic amines for the cation and neutral organics for the anion as well as test data on the PMN substance, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 200 ppb of the PMN substance 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 insufficient information to make a reasoned evaluation and a finding that the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires: 1. Submission of certain toxicity testing on the PMN substance prior to exceeding the confidential production volume limit as specified in the Order. 2. Use of personal protective equipment (where there is a potential for dermal exposure). 3. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS. 4. No manufacture in any manner or method that results in inhalation exposure. 5. No use of the PMN substance in an application method that generates a vapor, mist, or aerosol. 6. No release of the PMN substance resulting in surface water concentrations that exceed 200 ppb. The SNUR will designate as a ‘‘significant new use’’ the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the human health and aquatic toxicity of the PMN substance may be potentially useful to characterize the effects of the PMN substance 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 PO 00000 Frm 00010 Fmt 4701 Sfmt 4700 be designated by this SNUR. The submitter has agreed not to exceed the confidential production limit without performing chronic aquatic toxicity tests. In addition, EPA has determined that the results of specific target organ toxicity testing 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, 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 721.11045. PMN Number: P–16–513 Chemical name: Hydroxy alkylbiphenyl (generic). CAS number: Not available. Effective date of TSCA section 5(e) Order: May 2, 2017. Basis for TSCA section 5(e) Order: The PMN states that the substance will be used as a chemical intermediate. Based on test data on an analog, EPA has identified concerns for developmental toxicity, systemic toxicity, blood effects, and corrosion of the skin, eyes, and mucous membranes. Further, based on SAR analysis of test data on analogous amides, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 17 ppb of the PMN substances 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 insufficient information to make a reasoned evaluation and a finding that the substances may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires: 1. Submission of certain toxicity testing on the PMN substance prior to exceeding the confidential production volume limit as specified in the Order. 2. Use of personal protective equipment (where there is a potential for dermal exposure). 3. Use of a NIOSH-certified respirator with an APF of at least 50 (where there is a potential for 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. Use of the PMN substance only as a chemical intermediate. E:\FR\FM\01AUR2.SGM 01AUR2 Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Rules and Regulations sradovich on DSK3GMQ082PROD with RULES2 5. No release of the PMN substance resulting in surface water concentrations that exceed 17 ppb. The SNUR will designate as a ‘‘significant new use’’ the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the human health and aquatic 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 target organ toxicity and reproductive/developmental toxicity testing. In addition, EPA has determined that the results of acute aquatic toxicity tests may be potentially useful in characterizing the environmental effects of the PMN substance. Although the Order does not require these additional tests, the Order’s restrictions on manufacture, processing, 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 721.11046. PMN Numbers: P–16–534, P–16–535, and P–16–536 Chemical names: Alkyl alkenoic acid, polymer with alkenylcarbomonocycle telomer with substituted alkanoic acid hydroxyl alkyl substituted alkenyl substituted alkyl ester, polyalkylene glycol alkyl ether alkyl alkenoate, dialkylene glycol diheteromonocyclic ether and alkylcarbomonocyclic alkenoate, metal salt (generic) (P–16– 534); Alkyl alkenoic acid, polymer with alkenylcarbomonocycle telomer with substituted alkanoic acid hydroxyl alkyl substituted alkenyl substituted alkyl ester, alkanediol diheteromonocyclic ether, polyalkylene glycol alkyl ether alkyl alkenoate and alkylcarbomonocyclic alkenoate, metal salt (generic) (P–16–535); and Alkyl alkenoic acid, polymer with bis heteromonocyclic substituted alkyl carbomonocycle, alkenylcarbomonocycle telomer with substituted alkanoic acid hydroxyl alkyl substituted alkenyl substituted alkyl ester, polyalkylene glycol alkyl ether alkyl alkenoate and alkylcarbomonocyclic alkenoate, metal salt (generic) (P–16–536). CAS numbers: Not available. VerDate Sep<11>2014 21:28 Jul 31, 2018 Jkt 244001 Effective date of TSCA section 5(e) Order: April 4, 2017. Basis for TSCA section 5(e) Order: The PMN states that the generic (nonconfidential) use of the substances will be a component of ink. Based on test data on structurally similar respirable particles, EPA has identified concerns for lung effects if inhaled, based on lung overload. In addition, EPA has identified ecotoxicity concerns for the substances if made with an acid component exceeding 20% of the molecular weight due potential for increased absorption and solubility. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on insufficient information to make a reasoned evaluation and a finding that the substances may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires: 1. Manufacture of the PMN substances such that the minimum average molecular weight is 1,800 daltons and the carboxylic acid content does not exceed 20%. 2. No domestic manufacture of the PMN substances. 3. Process or use of the PMN substances only for the use specified in the Order. The SNUR will designate as a ‘‘significant new use’’ the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the human health and aquatic toxicity of the PMN substances may be potentially useful to characterize the effects of the substances in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of specific target organ toxicity testing and an acute aquatic toxicity test of the PMN substances may be potentially useful in characterizing the health and environmental effects of the PMN substances. Although the Order does not require these tests, the Order’s restrictions on manufacture, processing, 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 citations: 40 CFR 721.11047 (P– 16–534), 40 CFR 721.11048 (P–16–535), and 40 CFR 721.11049 (P–16–536). PO 00000 Frm 00011 Fmt 4701 Sfmt 4700 37711 PMN Numbers: P–16–549, P–16–550, P– 16–551, P–16–553, P–16–555, P–16–556, P–16–557, P–16–558, P–16–560, P–16– 561, P–16–562, P–16–563, P–16–564, P– 16–565, and P–16–567 Chemical names: Alkaline functionalized methacrylate-substituted polymer (generic) (P–16–549, P–16–550, and P–16–551); Quatenary alkylamine functionalized methacrylate-substituted polymer (generic) (P–16–553); Neutral alcohol functionalized methacrylatesubstituted polymer (generic) (P–16–555 and P–16–556); Neutral alkyl salt functionalized methacrylate-substituted polymer (generic) (P–16–557, P–16–558, and P–16–560); Acid functionalized methacrylate-substituted polymer (generic) (P–16–561, P–16–562, P–16– 563, P–16–564, and P–16–565); and Alkylamine functionalized methacrylate-substituted polymer (generic) (P–16–567). CAS numbers: Not available. Effective date of TSCA section 5(e) Order: May 2, 2017. Basis for TSCA section 5(e) Order: The PMN states the substances will be use as crosslinked resins for chromatographic separation of biomolecules and biocatalysts. Based on test data on structurally similar respirable particles, EPA has identified concerns for lung effects, including lung overload. EPA has also identified irritation concerns for skin and eyes. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on insufficient information to make a reasoned evaluation and a finding that the substances may present an unreasonable risk of injury to human health. To protect against these risks, the Order requires: 1. Use of personal protective equipment including impervious gloves (where there is a potential for dermal exposure). 2. Manufacture of the PMN substances only in the physical form of spherical beads and with less than 0.1% below a particle size of 10 microns. 3. No domestic manufacture of the PMN substances. 4. Process or use of the PMN substances only for the uses specified in the Order. The SNUR will designate as a ‘‘significant new use’’ the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the human health toxicity of the PMN substances may be potentially useful to characterize the effects of the substances in support of a request by the PMN submitter to modify the Order, or E:\FR\FM\01AUR2.SGM 01AUR2 37712 Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Rules and Regulations 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 of the PMN substances may be potentially useful in characterizing the health effects of the PMN substances. Although the Order does not require this testing, the Order’s restrictions on manufacture, processing, 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 citations: 40 CFR 721.11050. sradovich on DSK3GMQ082PROD with RULES2 PMN Number: P–16–579 Chemical name: Waste plastics, poly(ethylene terephthalate), depolymd. with polypropylene glycol ether with glycerol (3:1), polymers with alkenoic and alkanoic acids (generic). CAS number: Not available. Effective date of TSCA section 5(e) Order: March 13, 2017. Basis for TSCA section 5(e) Order: The PMN states that the substance will be used as an ultraviolet curable coating resin. Based on test data on similar structural moieties, EPA has identified concerns for dermal and respiratory sensitization and irritation of mucous membranes. In addition, EPA has identified human health and environmental concerns for the substance if made with lower molecular weight due potential for increased absorption and solubility. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on insufficient information to make a reasoned evaluation and a finding that the substances may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires: 1. Use of personal protective equipment including gloves and protective clothing (where there is a potential for dermal exposure). 2. Use of a NIOSH-certified full face respirator with an APF of at least 50 (where there is a potential for 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 VerDate Sep<11>2014 21:28 Jul 31, 2018 Jkt 244001 that would indicate a different respirator.) 3. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS. 4. No manufacture of the PMN substance with an average molecular weight less than 1,100 Daltons. 5. Use of the PMN substance only as an ultraviolet curable coating resin. The SNUR will designate 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 human health and aquatic toxicity of the PMN substance may be potentially useful to characterize the effects of the 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 measurement of certain physical-chemical properties, the results of specific target organ toxicity, reproductive/developmental toxicity, sensitization, and acute and chronic aquatic toxicity testing may be potentially useful in characterizing the health and environmental effects of the PMN substances. Although the Order does not require these tests, the Order’s restrictions on manufacture, processing, 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 721.11051. PMN Number: P–17–32 Chemical name: 1,3,5Naphthalenetrisulfonic acid. CAS number: 6654–64–4. Effective date of TSCA section 5(e) Order: March 22, 2017. Basis for TSCA section 5(e) Order: The PMN states that the generic (nonconfidential) use of the substance is for monitoring of oil/gas well performance. Based on test data on an analog and physical/chemical properties of the PMN substance, EPA has identified concerns for dermal and respiratory irritation, developmental toxicity, and blood effects. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on insufficient PO 00000 Frm 00012 Fmt 4701 Sfmt 4700 information to make a reasoned evaluation and a finding that the substance may present an unreasonable risk of injury to human health. To protect against these risks, the Order requires: 1. Submission of certain toxicity testing on the PMN substance prior to exceeding the confidential production volume limit as specified in the Order. 2. Use of personal protective equipment including NIOSH-approved respirator (APF 50) and impervious gloves (where there is a potential for inhalation or dermal 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.) 3. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS. 4. No manufacture or processing of the PMN substance beyond a confidential annual production volume specified in the Order. 5. No manufacture, processing, or use using application methods that intentionally generate a vapor, mist or aerosol. The SNUR will designate as a ‘‘significant new use’’ the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the human health toxicity of the PMN substance may be potentially useful to characterize the effects of the PMN substance 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 target organ toxicity and developmental toxicity testing. CFR citation: 40 CFR 721.11052. PMN Numbers: P–17–33, P–17–34, P– 17–36, P–17–38, P–17–39, P–17–41, P– 17–42, P–17–43, P–17–45, P–17–47, P– 17–50, P–17–52, P–17–55, P–17–57, P– 17–59, P–17–61, P–17–62, P–17–63, P– 17–64, P–17–66, P–17–67, P–17–69, P– 17–71, P–17–72, P–17–73, P–17–75, P– 17–76, P–17–79, P–17–80, P–17–83, P– 17–85, P–17–87, P–17–90, P–17–91, P–17–93 E:\FR\FM\01AUR2.SGM 01AUR2 Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Rules and Regulations 37713 CHEMICAL NAMES AND CAS NUMBERS Chemical name sradovich on DSK3GMQ082PROD with RULES2 Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, 2-fluoro-, sodium salt (1:1) (P–17–33) ...................................................................................................................... 4-fluoro-, sodium salt (1:1) (P–17–34) ...................................................................................................................... 2,3,4,5-tetrafluoro-, sodium salt (1:1) (P–17–36) ..................................................................................................... 2-(trifluoromethyl)-, sodium salt (1:1) (P–17–38) ...................................................................................................... 4-(trifluoromethyl)-, sodium salt (1:1) (P–17–39) ...................................................................................................... 2,5-difluoro-, sodium salt (1:1) (P–17–41) ................................................................................................................ 3-fluoro-, sodium salt (1:1) (P–17–42) ...................................................................................................................... 2,6-difluoro-, sodium salt (1:1) (P–17–43) ................................................................................................................ 3,5-difluoro-, sodium salt (1:1) (P–17–45) ................................................................................................................ 2,4-difluoro-, sodium salt (1:1) (P–17–47) ................................................................................................................ 3,4-difluoro-, sodium salt (1:1) (P–17–50) ................................................................................................................ 3,4,5-trifluoro-, sodium salt (1:1) (P–17–52) ............................................................................................................. 2,3,4-trifluoro-, sodium salt (1:1) (P–17–55) ............................................................................................................. 2,4,5-trifluoro-, sodium salt (1:1) (P–17–57) ............................................................................................................. 2,3-difluoro-, sodium salt (1:1) (P–17–59) ................................................................................................................ 3-(trifluoromethyl)-, sodium salt (1:1) (P–17–61) ...................................................................................................... 2-chloro-, sodium salt (1:1) (P–17–62) ..................................................................................................................... 4-chloro-, sodium salt (1:1) (P–17–63) ..................................................................................................................... 3-chloro-, sodium salt (1:1) (P–17–64) ..................................................................................................................... 2,3-dichloro-, sodium salt (1:1) (P–17–66) ............................................................................................................... 2,5-dichloro-, sodium salt (1:1) (P–17–67) ............................................................................................................... 3,5-dichloro-, sodium salt (1:1) (P–17–69) ............................................................................................................... 2,6-dichloro-, sodium salt (1:1) (P–17–71) ............................................................................................................... 3,4-dichloro-, sodium salt (1:1) (P–17–72) ............................................................................................................... 2,4-dichloro-, sodium salt (1:1) (P–17–73) ............................................................................................................... 2-chloro-4-fluoro-, sodium salt (P–17–75) ................................................................................................................ 3-chloro-4-fluoro-, sodium salt (P–17–76) ................................................................................................................ 5-chloro-2-fluoro-, sodium salt (P–17–79) ................................................................................................................ 4-chloro-3-fluoro-, sodium salt (P–17–80) ................................................................................................................ 4-chloro-2-fluoro-, sodium salt (P–17–83) ................................................................................................................ 5-bromo-2-chloro-, sodium salt (P–17–85) ............................................................................................................... 3-bromo-4-fluoro-, sodium salt (P–17–87) ................................................................................................................ 2-bromo-5-fluoro-, sodium salt (P–17–90) ................................................................................................................ 4-bromo-2-fluoro-, sodium salt (P–17–91) ................................................................................................................ 4-bromo-3-fluoro-, sodium salt (P–17–93) ................................................................................................................ Effective date of TSCA section 5(e) Order: March 22, 2017. Basis for TSCA section 5(e) Order: The PMNs state that the generic (nonconfidential) use of the substances are for monitoring of oil/gas well performance. Based on test data on an analog, EPA has identified concerns for reproductive, developmental and neurotoxicity, as well as lung toxicity and dermal irritation. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on insufficient information to make a reasoned evaluation and a finding that the substances may present an unreasonable risk of injury to human health. EPA assessed risks based on the specific manufacturing, processing, use, process equipment, engineering controls, and handling practices (including worker activities and cleaning procedures) described in the PMN. To protect against these risks, the Order requires: 1. Submission of certain toxicity testing on the PMN substances prior to VerDate Sep<11>2014 CAS No. 21:28 Jul 31, 2018 Jkt 244001 exceeding the production volume limit as specified in the Order. 2. Use of personal protective equipment including impervious gloves (where there is a potential for dermal exposure). 3. Use of a NIOSH-certified respirator with an APF of at least 50 (where there is a potential for inhalation exposure) or compliance with a NCEL of 0.0184 ppm as an 8-hour time-weighted average. 4. Use of processes, process equipment, engineering controls, and handling practices specified in the Order for manufacturing and processing. 5. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS. 6. No manufacture or process of the PMN substances beyond a confidential annual production volume specified in the Order. The SNUR will designate as a ‘‘significant new use’’ the absence of these protective measures. PO 00000 Frm 00013 Fmt 4701 Sfmt 4700 6654–64–4 499–90–1 67852–79–3 2966–44–1 25832–58–0 522651–42–9 499–57–0 6185–28–0 530141–39–0 1765–08–8 522651–44–1 1180493–12–2 402955–41–3 522651–48–5 1604819–08–0 69226–41–1 17264–74–3 3686–66–6 17264–88–9 118537–84–1 63891–98–5 154862–40–5 10007–84–8 17274–10–1 38402–11–8 855471–43–1 1421761–18–3 1382106–78–6 1421029–88–0 1382106–64–0 1938142–12–1 938142–13–2 1938142–14–3 1938142–15–4 1535169–81–3 Potentially useful information: EPA has determined that certain information about the human health toxicity of the PMN substances may be potentially useful to characterize the effects of the PMN substances in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. The submitter has agreed not to exceed the confidential production limit without performing specific target organ toxicity testing on P–17–0091. CFR citations: 40 CFR 721.11053. PMN Numbers: P–17–35, P–17–37, P– 17–40, P–17–44, P–17–46, P–17–48, P– 17–51, P–17–53, P–17–54, P–17–56, P– 17–58, P–17–60, P–17–65, P–17–68, P– 17–70, P–17–74, P–17–77, P–17–78, P– 17–81, P–17–82, P–17–84, P–17–88, P– 17–89, P–17–92, P–17–97 E:\FR\FM\01AUR2.SGM 01AUR2 37714 Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Rules and Regulations CHEMICAL NAMES AND CAS NUMBERS Chemical Name Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, CAS No. 2,3,4,5-tetrafluoro- (P–17–35) ................................................................................................................................... 2-(trifluoromethyl)- (P–17–37) ................................................................................................................................... 2,5-difluoro- (P–17–40) ............................................................................................................................................. 2,6-difluoro- (P–17–44) ............................................................................................................................................. 3,5-difluoro- (P–17–46) ............................................................................................................................................. 2,4-difluoro- (P–17–48) ............................................................................................................................................. 3,4-difluoro- (P–17–51) ............................................................................................................................................. 3,4,5-trifluoro- (P–17–53) .......................................................................................................................................... 2,3,4-trifluoro- (P–17–54) .......................................................................................................................................... 2,4,5-trifluoro- (P–17–56) .......................................................................................................................................... 2,3-difluoro- (P–17–58) ............................................................................................................................................. 3-(trifluoromethyl)- (P–17–60) ................................................................................................................................... 2,3-dichloro- (P–17–65) ............................................................................................................................................ 3,5-dichloro- (P–17–68) ............................................................................................................................................ 2,6-dichloro- (P–17–70) ............................................................................................................................................ 2-chloro-4-fluoro- (P–17–74) ..................................................................................................................................... 5-chloro-2-fluoro- (P–17–77) ..................................................................................................................................... 3-chloro-4-fluoro- (P–17–78) ..................................................................................................................................... 4-chloro-3-fluoro- (P–17–81) ..................................................................................................................................... 4-chloro-2-fluoro- (P–17–82) ..................................................................................................................................... 5-bromo-2-chloro- (P–17–84) ................................................................................................................................... 3-bromo-4-fluoro- (P–17–88) .................................................................................................................................... 2-bromo-5-fluoro- (P–17–89) .................................................................................................................................... 4-bromo-3-fluoro- (P–17–92) .................................................................................................................................... 4-bromo-2-fluoro- (P–17–97) .................................................................................................................................... Effective date of TSCA section 5(e) Order: March 22, 2017. Basis for TSCA section 5(e) Order: The PMNs state that the generic (nonconfidential) use of the substances are for monitoring of oil/gas well performance. Based on test data on an analog, EPA has identified concerns for reproductive, developmental and neurotoxicity, as well as lung toxicity and dermal irritation. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on insufficient information to make a reasoned evaluation and a finding that the substances may present an unreasonable risk of injury to human health. EPA assessed risks based on the specific manufacturing, processing, use, process equipment, engineering controls, and handling practices (including worker activities and cleaning procedures) described in the PMN. To protect against these risks, the Order requires: 1. Submission of certain toxicity testing on the PMN substances prior to exceeding the production volume limit as specified in the Order. 2. Use of personal protective equipment including impervious gloves (where there is a potential for dermal exposure). 3. Use of a NIOSH-certified respirator with an APF of at least 50 (where there is a potential for inhalation exposure) or compliance with a NCEL of 0.0184 ppm as an 8-hour time-weighted average to prevent inhalation exposure. 4. Use of processes, process equipment, engineering controls, and handling practices specified in the Order for manufacturing and processing. 5. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS. 6. No manufacture or process of the PMN substances beyond a confidential annual production volume specified in the Order. The SNUR will designate as a ‘‘significant new use’’ the absence of these protective measures. 1201–31–6 433–97–6 2991–28–8 385–00–2 455–40–3 1583–58–0 455–86–7 121602–93–5 61079–72–9 446–17–3 4519–39–5 454–92–2 50–45–3 51–36–5 50–30–6 2252–51–9 394–30–9 403–16–7 403–17–8 446–30–0 21739–92–4 11007–16–5 394–28–5 153556–42–4 112704–79–7 Potentially useful information: EPA has determined that certain information about the human health toxicity of the PMN substances may be potentially useful to characterize the effects of the PMN substances in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. The submitter has agreed not to exceed the confidential production limit without performing specific target organ toxicity and reproductive/developmental toxicity testing on both P–17–35 and P– 17–37. CFR citations: 40 CFR 721.11054. PMN Numbers: P–17–94, P–17–95, P– 17–96, P–17–98, P–17–99, P–17–100, P– 17–101, P–17–102, P–17–103, P–17–104, P–17–105, P–17–114, P–17–122, P–17– 123, P–17–124, P–17–125, P–17–126, P– 17–127, P–17–128, P–17–129, P–17–130, P–17–131, P–17–132, P–17–133, P–17– 134, P–17–135, P–17–136, P–17–137, P– 17–138, P–17–139, and P–17–140 CHEMICAL NAMES AND CAS NUMBERS sradovich on DSK3GMQ082PROD with RULES2 Chemical name Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic acid, acid, acid, acid, acid, acid, acid, acid, VerDate Sep<11>2014 CAS No. 2,3,4,5-tetrafluoro-, ethyl ester (P–17–94) ................................................................................................................ 4-(trifluoromethyl)-, ethyl ester (P–17–95) ................................................................................................................ 2-(trifluoromethyl)-, ethyl ester (P–17–96) ................................................................................................................ 2,6-difluoro-, ethyl ester (P–17–98) .......................................................................................................................... 2,5-difluoro-, ethyl ester (P–17–99) .......................................................................................................................... 2,3,4-trifluoro-, ethyl ester (P–17–100) ..................................................................................................................... 2-bromo-5-fluoro-, ethyl ester (P–17–101) ............................................................................................................... 3,5-difluoro-, ethyl ester (P–17–102) ........................................................................................................................ 21:28 Jul 31, 2018 Jkt 244001 PO 00000 Frm 00014 Fmt 4701 Sfmt 4700 E:\FR\FM\01AUR2.SGM 01AUR2 122894–73–9 583–02–8 577–62–8 19064–14–3 708–25–8 351354–50–2 351354–50–2 350–19–6 Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Rules and Regulations 37715 CHEMICAL NAMES AND CAS NUMBERS—Continued Chemical name sradovich on DSK3GMQ082PROD with RULES2 Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, 5-bromo-2-chloro-, ethyl ester (P–17–103) .............................................................................................................. 3-chloro-, ethyl ester (P–17–104 .............................................................................................................................. 2-chloro-, ethyl ester (P–17–105) ............................................................................................................................. 3-chloro-4-fluoro-, ethyl ester (P–17–114) ................................................................................................................ 4-bromo-2-fluoro-, ethyl ester (P–17–122) ............................................................................................................... 2-bromo-4,5-difluoro-, ethyl ester (P–17–123) ......................................................................................................... 4-bromo-3-fluoro-, ethyl ester (P–17–124) ............................................................................................................... 3-bromo-4-fluoro-, ethyl ester (P–17–125) ............................................................................................................... 4-chloro-2-fluoro-, ethyl ester (P–17–126) ................................................................................................................ 2,5-dichloro-, ethyl ester (P–17–127) ....................................................................................................................... 4-chloro-3-fluoro-, ethyl ester (P–17–128) ................................................................................................................ 2-chloro-4-fluoro-, ethyl ester (P–17–129) ................................................................................................................ 5-chloro-2-fluoro-, ethyl ester (P–17–130) ................................................................................................................ 2,4-difluoro-, ethyl ester (P–17–131) ........................................................................................................................ 3,4-difluoro-, ethyl ester (P–17–132) ........................................................................................................................ 3,4,5-trifluoro-, ethyl ester (P–17–133) ..................................................................................................................... 2,4,5-trifluoro-, ethyl ester (P–17–134) ..................................................................................................................... 3-(trifluoromethyl)-, ethyl ester (P–17–135) .............................................................................................................. 2,3-difluoro-, ethyl ester (P–17–136) ........................................................................................................................ 2,6-dichloro-, ethyl ester (P–17–137) ....................................................................................................................... 3,5-dichloro-, ethyl ester (P–17–138) ....................................................................................................................... 2,4-dichloro-, ethyl ester (P–17–139) ....................................................................................................................... 3,4-dichloro-, ethyl ester (P–17–140) ....................................................................................................................... Effective date of TSCA section 5(e) Order: March 22, 2017. Basis for TSCA section 5(e) Order: The PMNs state that the substances are for monitoring oil/gas well performance. Based on test data on an analog, EPA has identified concerns for reproductive, developmental and neurotoxicity, as well as lung toxicity and dermal irritation. Further, based on SAR analysis of test data on analogous neutral organics, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 15 ppb of the PMN substances 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 insufficient information to make a reasoned evaluation and a finding that the substances may present an unreasonable risk of injury to human health and the environment. EPA assessed risks based on the specific manufacturing, processing, use, process equipment, engineering controls, and handling practices (including worker activities and cleaning procedures) described in the PMNs. To protect against these risks, the Order requires: 1. Submission of certain toxicity testing on the PMN substances prior to exceeding the production volume limit as specified in the Order. 2. Use of personal protective equipment including impervious gloves (where there is a potential for dermal exposure). 3. Use of a NIOSH-certified respirator with an APF of at least 1,000 (where there is a potential for inhalation exposure) or compliance with a NCEL of VerDate Sep<11>2014 CAS No. 21:28 Jul 31, 2018 Jkt 244001 0.0184 ppm as an 8-hour time-weighted average. 4. Use of processes, process equipment, engineering controls, and handling practices specified in the Order for manufacturing and processing. 5. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS. 6. No manufacture or process of the PMN substances beyond a confidential annual production volume specified in the Order. 7. No release of the PMN substances resulting in surface water concentrations that exceed 15 ppb. The SNUR will designate as a ‘‘significant new use’’ the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the human health and aquatic toxicity of the PMN substances may be potentially useful to characterize the effects of the PMN substances in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. The submitter has agreed not to exceed the confidential production limit without performing specific target organ toxicity and reproductive/developmental toxicity testing on P–17–127; specific target organ toxicity testing on P–17– 101; and acute aquatic toxicity testing on both P–17–101 and P–17–127. CFR citations: 40 CFR 721.11055. PO 00000 Frm 00015 Fmt 4701 Sfmt 4700 76008–73–6 1128–76–3 7335–25–3 137521–81–4 474709–71–2 144267–97–0 1130165–74–0 23233–33–2 4793–20–8 35112–27–7 203573–08–4 167758–87–4 773139–56–3 108928–00–3 144267–96–9 495405–09–9 351354–41–1 76783–59–0 773134–65–9 81055–73–4 91085–56–2 56882–52–1 28394–58–3 PMN Number: P–17–198 Chemical name: Neodymium aluminium alkyl polymer complexes (generic). CAS number: Not available. Effective date of TSCA section 5(e) Order: April 27, 2017. Basis for TSCA section 5(e) Order: The PMN states the generic (nonconfidential) use of the substance will be as a catalyst in a closed process. Based on physical/chemical properties of the substance and test data on the PMN substance, EPA has identified concerns for dermal and respiratory irritation, corrosion, developmental toxicity, and lung effects. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on insufficient information to make a reasoned evaluation and a finding that the substance may present an unreasonable risk of injury to human health. To protect against these risks, the Order requires: 1. Submission of glove permeation testing on the PMN substance prior to exceeding the production volume limit as specified in the Order. 2. Use of personal protective equipment including impervious gloves (where there is a potential for dermal exposure). 3. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS. 4. No domestic manufacture of the PMN substance. 5. No use in any manner or method where there is potential for inhalation exposure. E:\FR\FM\01AUR2.SGM 01AUR2 37716 Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Rules and Regulations 6. Use of the PMN substance in a closed system as specified in the PMN. The SNUR will designate as a ‘‘significant new use’’ the absence of these protective measure. Potentially useful information: EPA has determined that the results of glove permeability testing will help characterize the effectiveness of protective measures to mitigate human health risk 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 manufacture beyond a certain time period without performing glove permeability testing. CFR citation: 40 CFR 721.11056. sradovich on DSK3GMQ082PROD with RULES2 PMN Numbers: P–17–272, P–17–273, P– 17–274, P–17–275, P–17–276 and P–17– 277 Chemical name: Fatty acid amide alkyl amine salts (generic). CAS numbers: Not available. Effective date of TSCA section 5(e) Order: August 4, 2017. Basis for TSCA section 5(e) Order: The PMNs state that the generic (nonconfidential) use of the substances will be as a component in asphalt emulsion. Based on SAR analysis of test data on analogous substances, EPA has identified concerns for dermal and respiratory irritation, corrosion, developmental toxicity, systemic effect, sensitization and lung effects. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on insufficient information to make a reasoned evaluation and a finding that the substances may present an unreasonable risk of injury to human health and environment. To protect against these risks, the Order requires: 1. Use of the PMN substances only for the use specified in the Order. 2. Use of personal protective equipment for workers exposed dermally to the PMN substances (including impervious gloves, chemical goggles or equivalent eye protection and clothing which covers any other exposed areas of the arms and torso). 3. No modification of the manufacture, process or use of the PMN substances if it results in inhalation exposure to vapor, dust, mist or aerosol. 4. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS. 5. No release of the PMN substances into the waters of the United States. VerDate Sep<11>2014 21:28 Jul 31, 2018 Jkt 244001 The SNUR will designate as a ‘‘significant new use’’ the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the human health and aquatic toxicity of the PMN substances may be potentially useful to characterize the effects of the PMN substances in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of specific target organ toxicity testing of the PMN substances, and acute and chronic aquatic toxicity testing of the PMN substances may be potentially useful in characterizing the health and environmental effects of the PMN substances. Although the Order does not require these tests, the Order’s restrictions on manufacture, processing and distribution in commerce, 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 721.11057. PMN Numbers: P–17–278, P–17–279 and P–17–280 Chemical name: Fatty acid amide alkyl amine salts (generic). CAS numbers: Not available. Effective date of TSCA section 5(e) Order: August 4, 2017. Basis for TSCA section 5(e) Order: The PMNs state that the generic (nonconfidential) use of the substances will be as a component in asphalt emulsion. Based on SAR analysis of test data on analogous substances, EPA has identified concerns for irritation, corrosion, developmental toxicity, systemic effect, sensitization and lung effects. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on insufficient information to make a reasoned evaluation and a finding that the substances may present an unreasonable risk of injury to human health and environment. To protect against these risks, the Order requires: 1. Use of the PMN substances only for the use specified in the Order. 2. Use of personal protective equipment for workers exposed dermally to the PMN substances (including impervious gloves, chemical goggles or equivalent eye protection and clothing which covers any other exposed areas of the arms and torso). PO 00000 Frm 00016 Fmt 4701 Sfmt 4700 3. No modification of the manufacture, process or use of the PMN substances if it results in inhalation exposure to vapor, dust, mist or aerosol. 4. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS. 5. No release of the PMN substances into the waters of the United States. The SNUR will designate as a ‘‘significant new use’’ the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the human health and aquatic toxicity of the PMN substances may be potentially useful to characterize the effects of the PMN substances in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of specific target organ toxicity testing and acute and chronic aquatic toxicity testing of the PMN substances may be potentially useful in characterizing the health and environmental effects of the PMN substances. Although the Order does not require these tests, the Order’s restrictions on manufacture, processing and distribution in commerce 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 721.11058. 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 145 chemical substances regulation was warranted under TSCA section 5(e), pending the development of information sufficient to make reasoned evaluations of the health or environmental effects of the chemical substances. The basis for such findings is outlined in Unit IV. Based on these findings, TSCA section 5(e) consent 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). E:\FR\FM\01AUR2.SGM 01AUR2 Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Rules and Regulations 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. sradovich on DSK3GMQ082PROD with RULES2 VI. Direct Final Procedures EPA is issuing these SNURs as a direct final rule. The effective date of this rule is October 1, 2018 without further notice, unless EPA receives written adverse comments before August 31, 2018. If EPA receives written adverse comments on one or more of these SNURs before August 31, 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. VerDate Sep<11>2014 21:28 Jul 31, 2018 Jkt 244001 37717 VII. Applicability of the Significant New Use Designation notice, and has taken such actions as are required with that determination. 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) consent orders have been issued for all of the chemical substances, and the PMN submitters are prohibited by the TSCA section 5(e) consent orders from undertaking activities which will be designated as significant new uses. The identities of 38 of the 145 chemical substances subject to this rule have been claimed as confidential and EPA has received one post-PMN bona fide submission (per §§ 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 1, 2018 (the date of public release of this rule) 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 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) consent orders for the chemical substances regulated under this rule, EPA has established production volume limits in view of the lack of data on the potential health and environmental risks that may be posed by the significant new uses or increased exposure to the chemical substances. These limits cannot be exceeded unless the PMN submitter first submits the results of specified tests that would permit a reasoned evaluation of the PO 00000 Frm 00017 Fmt 4701 Sfmt 4700 E:\FR\FM\01AUR2.SGM 01AUR2 37718 Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Rules and Regulations sradovich on DSK3GMQ082PROD with RULES2 potential risks posed by these chemical substances. Under recent TSCA section 5(e) consent orders, each PMN submitter is required to submit each study at least 14 weeks (earlier TSCA section 5(e) consent 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) consent 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 nonexempt commercial manufacture or processing. Any request by EPA for the triggered and pended testing described in the Consent 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 highthroughput 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 VerDate Sep<11>2014 21:28 Jul 31, 2018 Jkt 244001 required to keep this information confidential. EPA promulgated a procedure to deal with the situation where a specific significant new use is CBI, at § 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 § 721.1725(b)(1) with that under § 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 § 721.1(c), persons submitting a SNUN must comply with the same notification requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in 40 CFR 720.50. SNUNs must be submitted on EPA Form No. 7710–25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in 40 CFR 720.40 and § 721.25. E–PMN software is available electronically at http:// www.epa.gov/opptintr/newchems. PO 00000 Frm 00018 Fmt 4701 Sfmt 4700 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– 2017–0366. 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) consent orders. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled ‘‘Regulatory Planning and Review’’ (58 FR 51735, October 4, 1993). B. Paperwork Reduction Act (PRA) According to PRA (44 U.S.C. 3501 et seq.), an agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA’s regulations in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR part 9, and included on the related collection instrument or form, if applicable. EPA is amending the table in 40 CFR part 9 to list the OMB approval number for the information collection requirements contained in this action. This listing of the OMB control numbers and their subsequent codification in the CFR satisfies the display requirements of PRA and OMB’s implementing regulations at 5 CFR part 1320. This Information Collection Request (ICR) was previously subject to public notice and comment prior to OMB approval, and given the technical nature of the table, EPA finds that further notice and comment to amend it is unnecessary. As a result, EPA finds that there is ‘‘good cause’’ under section 553(b)(3)(B) of the Administrative Procedure Act (5 U.S.C. 553(b)(3)(B)) to amend this table without further notice and comment. The information collection requirements related to this action have already been approved by OMB pursuant to PRA under OMB control number 2070–0012 (EPA ICR No. 574). This action does not impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average between 30 and 170 hours per response. This burden estimate E:\FR\FM\01AUR2.SGM 01AUR2 37719 Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Rules and Regulations 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. 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. sradovich on DSK3GMQ082PROD with RULES2 D. Unfunded Mandates Reform Act (UMRA) I. National Technology Transfer and Advancement Act (NTTAA) 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 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. VerDate Sep<11>2014 21:28 Jul 31, 2018 Jkt 244001 J. Executive Order 12898 Frm 00019 Fmt 4701 Sfmt 4700 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: July 19, 2018. Jeffery T. Morris, Director, Office of Pollution Prevention and Toxics. Therefore, 40 CFR parts 9 and 721 are amended as follows: PART 9—[AMENDED] 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. 2. In § 9.1, add the following sections in numerical order under the undesignated center heading ‘‘Significant New Uses of Chemical Substances’’ to read as follows: ■ § 9.1 OMB approvals under the Paperwork Reduction Act. * * * * * OMB control No. 40 CFR citation * 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 PO 00000 Populations and Low-Income Populations’’ (59 FR 7629, February 16, 1994). * * * * Significant New Uses of Chemical Substances * * * 721.11024 ............................. E:\FR\FM\01AUR2.SGM 01AUR2 * * 2070–0012 37720 Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Rules and Regulations OMB control No. 40 CFR citation 721.11025 721.11026 721.11027 721.11028 721.11029 721.11030 721.11031 721.11032 721.11033 721.11034 721.11035 721.11036 721.11037 721.11038 721.11039 721.11040 721.11041 721.11042 721.11043 721.11044 721.11045 721.11046 721.11047 721.11048 721.11049 721.11050 721.11051 721.11052 721.11053 721.11054 721.11055 721.11056 721.11057 721.11058 ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. ............................. * * * * * * * 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 2070–0012 * * * PART 721—[AMENDED] 3. The authority citation for part 721 continues to read as follows: ■ Authority: 15 U.S.C. 2604, 2607, and 2625(c). 4. Add § 721.11024 to subpart E to read as follows: ■ sradovich on DSK3GMQ082PROD with RULES2 § 721.11024 Polyphosphoric acids, 2[alkyl-1-oxo-2-propen-1-yl)oxy]ethyl esters, compds. with N-(aminoiminomethyl)urea (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polyphosphoric acids, 2[alkyl-1-oxo-2-propen-1-yl)oxy]ethyl esters, compds. with N(aminoiminomethyl)urea (PMN P–14– 472) 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 § 721.63(a)(1), (3), and (c). (ii) Hazard communication. Requirements as specified in § 721.72(a) through (f), (g)(1)(i), (ii), (sensitization), VerDate Sep<11>2014 21:28 Jul 31, 2018 Jkt 244001 (g)(2)(i), (v), (g)(3)(i), (ii), (g)(4)(i), 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 § 721.80(h), (q), and (y)(1). It is a significant new use to have manufacturing activities that result in inhalation exposure. (iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) where N = 3. (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 § 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 § 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. ■ 5. Add § 721.11025 to subpart E to read as follows: § 721.11025 Polyphosphoric acids, 2-[(2methyl-1-oxo-2-propen-1-yl)oxy]ethyl esters, compds. with alkyl amino, polymers with Bu acrylate, N(hydroxymethyl)propenamide and styrene (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polyphosphoric acids, 2[(2-methyl-1-oxo-2-propen-1yl)oxy]ethyl esters, compds. with alkyl amino, polymers with Bu acrylate, N(hydroxymethyl)propenamide and styrene (PMN P–14–496) 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 § 721.63(a)(1), (3), and (c). (ii) Hazard communication. Requirements as specified in § 721.72(a), through (f), (g)(1)(i), (ii), (sensitization), (g)(2)(i), (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 § 721.80(k), (q) and (y)(1). It PO 00000 Frm 00020 Fmt 4701 Sfmt 4700 is a significant new use to have manufacturing activities that result in inhalation exposure. (iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) where N = 4. (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 § 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 § 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. ■ 6. Add § 721.11026 to subpart E to read as follows: § 721.11026 oxide. Bismuth bromide iodide (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as bismuth bromide iodide oxide (PMN P– 14–630, CAS No. 340181–06–8) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been reacted (cured). (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in § 721.63(a)(4), when determining which persons are reasonably likely to be exposed as required for § 721.63(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 10), (a)(6)(i) (particulate), (b) (concentration set at 1.0%), 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 2.4 mg/m3 as an 8-hour time weighted average. Persons who wish to pursue NCELs as an alternative to § 721.63 respirator requirements may request to do so E:\FR\FM\01AUR2.SGM 01AUR2 Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Rules and Regulations under § 721.30. Persons whose § 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 § 721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(ii), (g)(2)(ii), (use respiratory protection or maintain workplace airborne concentrations at or below an 8-hour time-weighted average of 2.4 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 § 721.80(q). It is a significant new use to vary or alter, the manufacturing, processing, and use, distribution/transportation, treatment and disposal processes, process equipment, engineering controls, and handling practices (including worker activities and cleaning procedures) described in the PMN in such a way as to change the magnitude of inhalation exposure. It is a significant new use to use the substance for a consumer product that generates a dust, mist, or aerosol. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (d), and (f) through (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. ■ 7. Add § 721.11027 to subpart E to read as follows: sradovich on DSK3GMQ082PROD with RULES2 § 721.11027 Aluminum cobalt lithium nickel oxide. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as aluminum cobalt lithium nickel oxide (PMN P–15–450, CAS No. 177997–13–6) 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 § 721.63(a)(1), (3), (4), when VerDate Sep<11>2014 21:28 Jul 31, 2018 Jkt 244001 determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible, (a)(5) (respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 1,000), (a)(6) (particulate) (b) (concentration set at 0.1%), and (c). It is a significant new use to manufacture or process the substance without the chemical transfer processes and air ventilation processes described in the PMN and the exposure monitoring requirements described in the Order. (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 0.000092 mg/m3 as an 8-hour time weighted average. Persons who wish to pursue NCELs as an alternative to § 721.63 respirator requirements may request to do so under § 721.30. Persons whose § 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 § 721.72(a) through (e) (concentration set 0.1%), (f), (g)(1)(ii), (This substance may cause damage to the lung, kidney, and spleen), (g)(1)(vii), (g)(2)(i), (ii), (iii), (When using this substance wear protective gloves/protective clothing/eye protection/face protection), the following human health precautionary statement must appear on the SDS as specified in paragraph (a)(2)(ii): (When using this substance use respiratory protection or maintain workplace airborne concentrations at or below an 8-hour time-weighted average of 0.000092 mg/m3), (g)(2)(v), 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 § 721.80(p) (24 months and 6 years). (iv) Disposal. Requirements as specified in § 721.85(a)(2), (b)(2), and (c)(2). It is a significant new use to PO 00000 Frm 00021 Fmt 4701 Sfmt 4700 37721 release this chemical substance to air unless using the chemical transfer and air ventilation processes described in P– 15–0450 including filtering through a high-efficiency particular air filter with an efficiency rate of 99.99% before release to air. (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 § 721.125(a) through (j) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. ■ 8. Add § 721.11028 to subpart E to read as follows: § 721.11028 Alkylarylamine (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkylarylamine (PMN P– 15–705) 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 § 721.63(a)(1), (a)(2)(i), (ii), (iii), (a)(3), and (4), when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible, (a)(5) (respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 1,000), (a)(6)(particulate), (a)(6)(v), (vi), (b) (concentration set at 0.1%), 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 0.48 mg/m3 as an 8-hour time weighted average. Persons who wish to pursue NCELs as an alternative to § 721.63 respirator requirements may request to do so under § 721.30. Persons whose § 721.30 requests to use the NCELs approach are E:\FR\FM\01AUR2.SGM 01AUR2 37722 Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Rules and Regulations 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 § 721.72(a) through (e) (concentration set at 0.1%), (f), (g)(1)(i), (ii), (iv), (vi), (vii), (ix), (g)(2)(i), (ii), (iii), (use respiratory protection or maintain workplace airborne concentrations at or below an 8-hour time-weighted average of 0.48 mg/m3), (g)(2)(v), (g)(3)(ii), (g)(4)(i), 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 § 721.80(o) and (q). It is a significant new use to use the substance other than as a chemical intermediate or as an additive and octane booster in aviation fuels. (iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) where N = 1. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in § 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 § 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. ■ 9. Add § 721.11029 to subpart E to read as follows: sradovich on DSK3GMQ082PROD with RULES2 § 721.11029 Aliphatic N-alkyl urea polymer containing cyclohexyl groups and trimethoxy silanes (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as aliphatic N-alkyl urea polymer containing cyclohexyl groups and trimethoxy silanes (PMN P–15–706) 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 § 721.63(a)(1), (a)(2)(i),(iii), (iv), (a)(3) and (4), when determining which VerDate Sep<11>2014 21:28 Jul 31, 2018 Jkt 244001 persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible, (a)(5) (respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 10), (a)(6) (particulate), (a)(6)(v), (vi), (b) (concentration set at 1.0%), 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/m3 as an 8-hour time weighted average. Persons who wish to pursue NCELs as an alternative to § 721.63 respirator requirements may request to do so under § 721.30. Persons whose § 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 § 721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(ii), (ix), (g)(2)(i), (ii), (iii), (use respiratory protection or maintain workplace airborne concentrations at or below an 8-hour time-weighted average of 0.9 mg/m3), (g)(2)(v), 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 § 721.80(k), (o), (p) (594,000 kilograms, P–15–706 and P–15–707 combined), and (t)(250,000 kilograms, P–15–706 and P–15–707 combined). A significant new use is any manufacture, processing, or use of the PMN substance with more than 0.1% residual isocyanate by weight. (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 § 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 § 721.185 apply to this section. PO 00000 Frm 00022 Fmt 4701 Sfmt 4700 (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. ■ 10. Add § 721.11030 to subpart E to read as follows: § 721.11030 Aliphatic N-alkyl urea polymer containing aspartic ester groups and trimethoxy silanes (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as aliphatic N-alkyl urea polymer containing aspartic ester groups and trimethoxy silanes (PMN P– 15–707) 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 § 721.63(a)(1), (a)(2)(i), (iii), (iv), (a)(3), (4), when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible, (a)(5) (respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 10), (a)(6)(i), (v), (vi), (b) (concentration set at 1.0%), 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/m3 as an 8-hour time weighted average. Persons who wish to pursue NCELs as an alternative to § 721.63 respirator requirements may request to do so under § 721.30. Persons whose § 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 § 721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(ii), (g)(1)(ix), (g)(2)(i), (ii), (iii), (use respiratory protection or maintain workplace airborne concentrations at or below an 8-hour time-weighted average of 0.9 mg/m3), (g)(2)(v), and (g)(5). E:\FR\FM\01AUR2.SGM 01AUR2 Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Rules and Regulations 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 § 721.80(k), (o), (p) (594,000 kilograms, P–15–706 and P–15–707 combined), and (t) (250,000 kilograms, P–15–706 and P–15–707 combined). A significant new use is any manufacture, processing, or use of the PMN substance with more than 1% residual isocyanate by weight. (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 § 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 § 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. ■ 11. Add § 721.11031 to subpart E to read as follows: sradovich on DSK3GMQ082PROD with RULES2 § 721.11031 Alkyl heteromonocycle, polymer with heteromonocycle, carboxyalkyl alkyl ether (generic). (a) Chemical substances and significant new uses subject to reporting. (1) The chemical substances identified generically as alkyl heteromonocycle, polymer with heteromonocycle, carboxyalkyl alkyl ether (PMNs P–16– 273 and P–16–0274) are 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 § 721.63(a)(1), (a)(2)(i), (iii), (a)(3), (b) (concentration set at 1.0%), and (c). When determining which persons are reasonably likely to be exposed as required for § 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. (ii) Hazard communication. Requirements as specified in § 721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i), (ii), (dermal sensitization), (g)(2)(i), (ii), (iii), and (v), (g)(3)(i), (ii), (g)(4)(iii), and (g)(5). Alternative hazard VerDate Sep<11>2014 21:28 Jul 31, 2018 Jkt 244001 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 § 721.80(f). It is a significant new use to use the substances for the uses specified in the Order, at a concentration greater than 3% of the metal working fluid, and use other than the closed metal working systems as specified in the PMNs with no modifications in the process that would result in worker inhalation exposure. (iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) where N = 10. (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 § 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 § 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. ■ 12. Add § 721.11032 to subpart E to read as follows: § 721.11032 Benzene dicarboxylic acid, polymer with alkane dioic acid and aliphatic diamine (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as generically as benzene dicarboxylic acid, polymer with alkane dioic acid and aliphatic diamine (PMN P–16–289) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k)(Manufacture only in a form with a particle size distribution where less than 1.0 percent of the particles are less than 10 microns) and (p) (six months). (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 § 721.125(a) through (c), and (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The PO 00000 Frm 00023 Fmt 4701 Sfmt 4700 37723 provisions of § 721.185 apply to this section. ■ 13. Add § 721.11033 to subpart E to read as follows: § 721.11033 Manganese cyclic (tri)amine chloride complex (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as manganese cyclic (tri)amine chloride complex (PMN P– 16–322) 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 § 721.63(a)(1), (3), (4), when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible, (a)(5) (respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 25), (a)(6)(i), (particulate), (b) (concentration set at 1.0%), 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 1.2 mg/m3 as an 8-hour time weighted average. Persons who wish to pursue NCELs as an alternative to § 721.63 respirator requirements may request to do so under § 721.30. Persons whose § 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 § 721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(iv), (vi), (viii), (ix), (g)(2)(i), (ii), (iii), (use respiratory protection or maintain workplace airborne concentrations at or below an 8-hour time-weighted average of 1.2 mg/m3), (v), (g)(3) (This substance may be toxic to algae. This substance may be harmful to invertebrates), (g)(4)(i), (ii), (do not release to water to yield surface water E:\FR\FM\01AUR2.SGM 01AUR2 37724 Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Rules and Regulations concentrations above 18 ppb.), 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 § 721.80(f), (k), and (q). (iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) where N = 18. (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 § 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 § 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. ■ 14. Add § 721.11034 to subpart E to read as follows: sradovich on DSK3GMQ082PROD with RULES2 § 721.11034 Xanthylium, (sulfoaryl)-bis [(substituted aryl) amino]-, sulfo derivs., inner salts, metal salts (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as xanthylium, (sulfoaryl)bis [(substituted aryl) amino]-, sulfo derivs., inner salts, metal salts (PMN P–16–338) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f), (k), and (t). (ii) Release to water. Requirements as specified in § 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 § 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 § 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(i) of this section. VerDate Sep<11>2014 21:28 Jul 31, 2018 Jkt 244001 15. Add § 721.11035 to subpart E to read as follows: ■ § 721.11035 Substituted triazinyl metal salt, diazotized, coupled with substituted pyridobenzimidazolesulfonic acids, substituted pyridobenzimidazolesulfonic acids, diazotized substituted alkanesulfonic acid, diazotized substituted aromatic sulfonate, diazotized substituted aromatic sulfonate, metal salts (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as substituted triazinyl metal salt, diazotized, coupled with substituted pyridobenzimidazolesulfonic acids, substituted pyridobenzimidazolesulfonic acids, diazotized substituted alkanesulfonic acid, diazotized substituted aromatic sulfonate, diazotized substituted aromatic sulfonate, metal salts (PMN P– 16–339) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f), (k), and (t). (ii) Release to water. Requirements as specified in § 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 § 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 § 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(i) of this section. ■ 16. Add § 721.11036 to subpart E to read as follows: § 721.11036 Carbon black, (organic acidic carbocyclic)-modified, inorganic salt (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as carbon black, (organic acidic carbocyclic)-modified, inorganic salt (PMN P–16–439) 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: PO 00000 Frm 00024 Fmt 4701 Sfmt 4700 (i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f), (k), and (t). (ii) Release to water. Requirements as specified in § 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 § 721.125(a) through (c), (i), and (k) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(i) of this section. ■ 17. Add § 721.11037 to subpart E to read as follows: § 721.11037 Carbon black, (organic acidic carbocyclic)-modified, metal salt (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as carbon black, (organic acidic carbocyclic)-modified, metal salt (PMN P–16–440) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f), (k), and (t). (ii) Release to water. Requirements as specified in § 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 § 721.125(a) through (c), (i), and (k) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(i) of this section. ■ 18. Add § 721.11038 to subpart E to read as follows: § 721.11038 Polyaralkyl aryl ester of methacrylic acid (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as E:\FR\FM\01AUR2.SGM 01AUR2 Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Rules and Regulations generically as polyaralkyl aryl ester of methacrylic acid (PMN P–16–350) 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 § 721.63(a)(1), (a)(2)(i), (a)(3), when determining which persons are reasonably likely to be exposed as required for § 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, and (c). (ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (f), (g)(1)(i), (ii), (sensitization), (mutagenicity); (g)(2)(i), (ii), (iii), (v), 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 § 721.80(k). It is a significant new use to manufacture the substance lower than the minimum average molecular weight identified in the Order and to contain more than the maximum weight percent of low molecular weight species below 1,000 daltons identified in the Order. (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 § 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 § 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. ■ 19. Add § 721.11039 to subpart E to read as follows: sradovich on DSK3GMQ082PROD with RULES2 § 721.11039 Phenol, 2-[[[3(octyloxy)propyl]imino]methyl]-. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as phenol, 2-[[[3(octyloxy)propyl]imino]methyl]- (PMN P–16–352, chemical A; CAS No. 1858221–49–4) is subject to reporting under this section for the significant VerDate Sep<11>2014 21:28 Jul 31, 2018 Jkt 244001 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 § 721.63(a)(1), (a)(2)(i), (a)(3), (a)(6)(v), (vi), (particulate), (b) (concentration set at 1.0%), and (c). When determining which persons are reasonably likely to be exposed as required for § 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. (ii) Hazard communication. Requirements as specified in § 721.72 (a) through (e) (concentration set at 1.0%), (f), (g)(1)(i), (iv), (vi), (ix), (g)(2)(i), (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 § 721.80(f), (p) (10,500 and 13,000 kilograms, respectively, for the total of this substance and the substance subject to 721.11039), (t) (250 kilograms for the total of this substance and the substance subject to 721.11039), and (y)(1). (iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) where N = 1. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in § 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 § 721.185 apply to this section. ■ 20. Add § 721.11040 to subpart E to read as follows: § 721.11040 Phenol, 2-[[[3(decyloxy)propyl]imino]methyl]-. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as phenol, 2-[[[3(decyloxy)propyl]imino]methyl]- (PMN P–16–352, chemical B; CAS No. 1858221–50–7) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: PO 00000 Frm 00025 Fmt 4701 Sfmt 4700 37725 (i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (a)(3), (a)(6)(v), (vi), (particulate), (b) (concentration set at 1.0%), and (c). When determining which persons are reasonably likely to be exposed as required for § 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. (ii) Hazard communication. Requirements as specified in § 721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i), (iv), (vi), (ix), (g)(2)(i), (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 § 721.80(f), (p) (10,500 and 13,000 kilograms respectively for the total of this substance and the substance subject to § 721.9998), (t) (250 kilograms for the total of this substance and the substance subject to § 721.9998), and (y)(1). (iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) where N = 1. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in § 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 § 721.185 apply to this section. ■ 21. Add § 721.11041 to subpart E to read as follows: § 721.11041 Alkyl phenol (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkyl phenol (PMN P–16– 358) 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 § 721.63(a)(1), (a)(2)(i), (iii), (iv), (a)(3), when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) engineering control measures (e.g., enclosure or E:\FR\FM\01AUR2.SGM 01AUR2 37726 Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Rules and Regulations confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible, (b) (concentration set at 1.0%), and (c). (ii) Hazard communication. Requirements as specified in § 721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(ix), (g)(2)(i), (ii), (iii), (v), (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 § 721.80(a) through (c), (g), (q), (y)(1), and (2). (iv) Release to water. Requirements as specified in § 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 § 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 § 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. ■ 22. Add § 721.11042 to subpart E to read as follows: sradovich on DSK3GMQ082PROD with RULES2 § 721.11042 Nitrile-butadiene-acrylate terpolymers (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as nitrile-butadiene-acrylate terpolymers PMN P–16–364) 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 § 721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(ii), (g)(2)(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. (ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(h), (k) (Manufacture of the substance with a particle size distribution where greater VerDate Sep<11>2014 21:28 Jul 31, 2018 Jkt 244001 than 5.0 percent of the particles are less than 10 microns). (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 § 721.125(a) through (c), and (f) through (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section. ■ 23. Add § 721.11043 to subpart E to read as follows: § 721.11043 Starch, polymer with 2propenoic acid, potassium salt, oxidized. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as starch, polymer with 2-propenoic acid, potassium salt, oxidized (PMN P–16– 399, CAS No. 1638117–09–5) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (6) (particulate), When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible, (b) (concentration set at 1.0%), and (c). (ii) Hazard communication. Requirements as specified in § 721.72(a), (b), (c), (d), (e) (concentration set 1.0%), (f), (g)(1)(ii), (g)(2)(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 § 721.80(k) (Manufacture of the substance with a particulate size less than 30 microns) and (p) (12 months). (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 § 721.125(a) through (d), and (f) through (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The PO 00000 Frm 00026 Fmt 4701 Sfmt 4700 provisions of § 721.185 apply to this section. ■ 24. Add § 721.11044 to subpart E to read as follows: § 721.11044 Pentanedioic acid, 2-methyl-. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as pentanedioic acid, 2-methyl- (PMN P– 16–430, CAS No. 617–62–9) 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 § 721.63 (a)(1), (a)(2)(i), (a)(3), (4), when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible, (a)(5) (respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 10), (a)(6)(i), (v), (vi), (b) (concentration set at 1.0%), and (c). (ii) Hazard communication. Requirements as specified in § 721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i), (ii), (vi), (g)(2)(i), (ii), (iii), (iv), (v), (g)(3)(i), (ii), (g)(4)(i), 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 § 721.80(f) and (k) (import of the substance at or below the maximum concentration specified in the Order). (iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) where N = 14. (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 § 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 § 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions E:\FR\FM\01AUR2.SGM 01AUR2 Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Rules and Regulations ■ § 721.11045 2-Pentanol, 4-methyl-, reaction products with phosphorus oxide (P2O5), compounds with alkylamine (generic). sradovich on DSK3GMQ082PROD with RULES2 of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. ■ 25. Add § 721.11045 to subpart E to read as follows: (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as hydroxy alkylbiphenyl (PMN P–16–513) 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 § 721.63(a)(1), (3), (4), when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible, (a)(5) (respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 50), (a)(6)(i), (v), (vi), (b) (concentration set at 1.0%), and (c). (ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(g) and (q). (iii) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) where N = 17. (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 § 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 § 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(ii) of this section. ■ 27. Add § 721.11047 to subpart E to read as follows: (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as generically as 2-pentanol, 4-methyl-, reaction products with phosphorus oxide (P2O5), compounds with alkylamine (PMN P–16–495) 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 § 721.63(a)(1), (3), when determining which persons are reasonably likely to be exposed as required for § 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) (concentration set at 1.0%), and (c). (ii) Hazard communication. Requirements as specified in § 721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i), (ii), (iv), (g)(2)(i), (ii), (v), (g)(3)(i), (ii), (g)(4)(i), 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 § 721.80(q) and (y)(1). A significant new use is any manner or method of manufacturing that results in inhalation exposure. (iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) where N = 200. (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 § 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 § 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. VerDate Sep<11>2014 21:28 Jul 31, 2018 Jkt 244001 26. Add § 721.11046 to subpart E to read as follows: § 721.11046 (generic). Hydroxy alkylbiphenyl § 721.11047 Alkyl alkenoic acid, polymer with alkenylcarbomonocycle telomer with substituted alkanoic acid hydroxyl alkyl substituted alkenyl substituted alkyl ester, polyalkylene glycol alkyl ether alkyl alkenoate, dialkylene glycol diheteromonocyclic ether and alkylcarbomonocyclic alkenoate, metal salt (generic). (a) Chemical substance and significant new uses subject to reporting. PO 00000 Frm 00027 Fmt 4701 Sfmt 4700 37727 (1) The chemical substance identified generically as alkyl alkenoic acid, polymer with alkenylcarbomonocycle telomer with substituted alkanoic acid hydroxyl alkyl substituted alkenyl substituted alkyl ester, polyalkylene glycol alkyl ether alkyl alkenoate, dialkylene glycol diheteromonocyclic ether and alkylcarbomonocyclic alkenoate, metal salt (PMN P–16–534) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f) and (k). It is a significant new use to manufacture the substance such that the lowest number average molecular weight is less than 1,800 daltons and the carboxylic acid content exceeds 20 percent). (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 § 721.125(a) through (c), and (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. ■ 28. Add § 721.11048 to subpart E to read as follows: § 721.11048 Alkyl alkenoic acid, polymer with alkenylcarbomonocycle telomer with substituted alkanoic acid hydroxyl alkyl substituted alkenyl substituted alkyl ester, alkanediol diheteromonocyclic ether, polyalkylene glycol alkyl ether alkyl alkenoate and alkylcarbomonocyclic alkenoate, metal salt (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkyl alkenoic acid, polymer with alkenylcarbomonocycle telomer with substituted alkanoic acid hydroxyl alkyl substituted alkenyl substituted alkyl ester, alkanediol diheteromonocyclic ether, polyalkylene glycol alkyl ether alkyl alkenoate and alkylcarbomonocyclic alkenoate, metal salt (PMN P–16–535) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Industrial, commercial, and consumer activities. Requirements as E:\FR\FM\01AUR2.SGM 01AUR2 37728 Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Rules and Regulations specified in § 721.80(f) and (k). It is a significant new use to manufacture the substance such that the lowest number average molecular weight is less than 1,800 daltons and the carboxylic acid content exceeds 20 percent). (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 § 721.125(a) through (c), and (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. 29. Add § 721.11049 to subpart E to read as follows: ■ § 721.11049 Alkyl alkenoic acid, polymer with bis heteromonocyclic substituted alkyl carbomonocycle, alkenylcarbomonocycle telomer with substituted alkanoic acid hydroxyl alkyl substituted alkenyl substituted alkyl ester, polyalkylene glycol alkyl ether alkyl alkenoate and alkylcarbomonocyclic alkenoate, metal salt (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkyl alkenoic acid, polymer with bis heteromonocyclic substituted alkyl carbomonocycle, alkenylcarbomonocycle telomer with substituted alkanoic acid hydroxyl alkyl substituted alkenyl substituted alkyl ester, polyalkylene glycol alkyl ether alkyl alkenoate and alkylcarbomonocyclic alkenoate, metal salt (PMN P–16–536) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f) and (k.) It is a significant new use to manufacture the substance such that the lowest number average molecular weight is less than 1,800 daltons, and the carboxylic acid content exceeds 20 percent). (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 § 721.125(a) through (c), and (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. 30. Add § 721.11050 to subpart E to read as follows: ■ § 721.11050 Certain functionalized methacrylate-substituted polymers. (a)(1) The chemical substances listed in the Table of this section 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 substances after they have been reacted (cured). TABLE—FUNCTIONALIZED METHACRYLATE-SUBSTITUTED POLYMERS PMN No. sradovich on DSK3GMQ082PROD with RULES2 P–16–549 P–16–550 P–16–551 P–16–553 P–16–555 P–16–556 P–16–557 P–16–558 P–16–560 P–16–561 P–16–562 P–16–563 P–16–564 P–16–565 P–16–567 Chemical name ........................................................................... ........................................................................... ........................................................................... ........................................................................... ........................................................................... ........................................................................... ........................................................................... ........................................................................... ........................................................................... ........................................................................... ........................................................................... ........................................................................... ........................................................................... ........................................................................... ........................................................................... (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (iii), (a)(3), when determining which persons are reasonably likely to be exposed as required for § 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) VerDate Sep<11>2014 21:28 Jul 31, 2018 Jkt 244001 Alkaline functionalized methacrylate-substituted polymer (generic). Alkaline functionalized methacrylate-substituted polymer (generic). Alkaline functionalized methacrylate-substituted polymer (generic). Quatenary alkylamine functionalized methacrylate-substituted polymer (generic). Neutral alcohol functionalized methacrylate-substituted polymer (generic). Neutral alcohol functionalized methacrylate-substituted polymer (generic). Neutral alkyl salt functionalized methacrylate-substituted polymer (generic). Neutral alkyl salt functionalized methacrylate-substituted polymer (generic). Neutral alkyl salt functionalized methacrylate-substituted polymer (generic). Acid functionalized methacrylate-substituted polymer (generic). Acid functionalized methacrylate-substituted polymer (generic). Acid functionalized methacrylate-substituted polymer (generic). Acid functionalized methacrylate-substituted polymer (generic). Acid functionalized methacrylate-substituted polymer (generic). Alkylamine functionalized methacrylate-substituted polymer (generic). (particulate), (b) (concentration set at 1.0%), and (c). (ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f) and (k) (crosslinked resin used for chromatographic separation of biomolecules and biocatalysts). It is a significant new use to import the substance in any form other than spherical beads with 0.1 percent less than 10 microns (b) Specific requirements. The provisions of subpart A of this part PO 00000 Frm 00028 Fmt 4701 Sfmt 4700 apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (e), and (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section. 31. Add § 721.11051 to subpart E to read as follows: ■ E:\FR\FM\01AUR2.SGM 01AUR2 Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Rules and Regulations § 721.11051 Waste plastics, poly(ethylene terephthalate), depolymd. with polypropylene glycol ether with glycerol (3:1), polymers with alkenoic and alkanoic acids (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as waste plastics, poly(ethylene terephthalate), depolymd. with polypropylene glycol ether with glycerol (3:1), polymers with alkenoic and alkanoic acids (PMN P–16–579) 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 § 721.63(a)(1), (a)(2)(i), (a)(3), (4),when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible, (a)(5) (respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 50), (a)(6) (particulate), (b) (concentration set 1.0%), and (c). (ii) Hazard communication. Requirements as specified in § 721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1) (This substance may cause respiratory and dermal irritation). (This substance may cause irritation of the mucous membranes). (This substance may cause respiratory and dermal sensitization). (This substance may cause mutagenicity), (g)(2)(i), (ii), (iii), (iv), (v), (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 § 721.80(k) (an ultraviolet curable coating resin). It is a significant new use to manufacture the substance with an average molecular weight less than 1,100 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 § 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 § 721.185 apply to this section. ■ 32. Add § 721.11052 to subpart E to read as follows: § 721.11052 acid. 1,3,5-Naphthalenetrisulfonic (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1,3,5-naphthalenetrisulfonic acid (PMN P–17–32, CAS No. 6654–64–4) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (iv), (a)(3), (4), when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) 37729 shall be considered and implemented to prevent exposure, where feasible, (a)(5) (respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor of at least 50, (a)(6)(v), (vi), (particulate), (b) (concentration set at 1.0%), and (c). (ii) Hazard communication. Requirements as specified in § 721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i), (ii), (iv), (ix), (g)(2)(i), (ii), (iii), (v), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System (GHS) and OSHA Hazard Communication Standard may be used. (iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(q) and (t). (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 § 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 § 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. ■ 33. Add § 721.11053 to subpart E to read as follows: § 721.11053 Certain halogenated sodium benzoate salts. (a)(1) The chemical substances listed in the Table of this section is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. TABLE—HALOGENATED SODIUM BENZOATE SALTS sradovich on DSK3GMQ082PROD with RULES2 PMN No. P–17–33 P–17–34 P–17–36 P–17–38 P–17–39 P–17–41 P–17–42 P–17–43 P–17–45 P–17–47 P–17–50 P–17–52 P–17–55 P–17–57 P–17–59 P–17–61 P–17–62 P–17–63 CAS No. .............................................................................. .............................................................................. .............................................................................. .............................................................................. .............................................................................. .............................................................................. .............................................................................. .............................................................................. .............................................................................. .............................................................................. .............................................................................. .............................................................................. .............................................................................. .............................................................................. .............................................................................. .............................................................................. .............................................................................. .............................................................................. VerDate Sep<11>2014 21:28 Jul 31, 2018 Jkt 244001 PO 00000 Frm 00029 Chemical name 6654–64–4 499–90–1 67852–79–3 2966–44–1 25832–58–0 522651–42–9 499–57–0 6185–28–0 530141–39–0 1765–08–8 522651–44–1 1180493–12–2 402955–41–3 522651–48–5 1604819–08–0 69226–41–1 17264–74–3 3686–66–6 Fmt 4701 Sfmt 4700 Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, 2-fluoro-, sodium salt (1:1). 4-fluoro-, sodium salt (1:1). 2,3,4,5-tetrafluoro-, sodium salt (1:1). 2-(trifluoromethyl)-, sodium salt (1:1). 4-(trifluoromethyl)-, sodium salt (1:1). 2,5-difluoro-, sodium salt (1:1). 3-fluoro-, sodium salt (1:1). 2,6-difluoro-, sodium salt (1:1). 3,5-difluoro-, sodium salt (1:1). 2,4-difluoro-, sodium salt (1:1). 3,4-difluoro-, sodium salt (1:1). 3,4,5-trifluoro-, sodium salt (1:1). 2,3,4-trifluoro-, sodium salt (1:1). 2,4,5-trifluoro-, sodium salt (1:1). 2,3-difluoro-, sodium salt (1:1). 3-(trifluoromethyl)-, sodium salt (1:1). 2-chloro-, sodium salt (1:1). 4-chloro-, sodium salt (1:1). E:\FR\FM\01AUR2.SGM 01AUR2 37730 Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Rules and Regulations TABLE—HALOGENATED SODIUM BENZOATE SALTS—Continued PMN No. P–17–64 P–17–66 P–17–67 P–17–69 P–17–71 P–17–72 P–17–73 P–17–75 P–17–76 P–17–79 P–17–80 P–17–83 P–17–85 P–17–87 P–17–90 P–17–91 P–17–93 CAS No. .............................................................................. .............................................................................. .............................................................................. .............................................................................. .............................................................................. .............................................................................. .............................................................................. .............................................................................. .............................................................................. .............................................................................. .............................................................................. .............................................................................. .............................................................................. .............................................................................. .............................................................................. .............................................................................. .............................................................................. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (2)(i), (iv), (a)(3), when determining which persons are reasonably likely to be exposed as required for § 721.63(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 of at least 50), (a)(6) (particulate), (a)(6)(v), (vi), (b) (concentration set at 1.0%), 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 0.0184 mg/m3 as an 8-hour time weighted average. Persons who wish to pursue NCELs as Chemical name 17264–88–9 118537–84–1 63891–98–5 154862–40–5 10007–84–8 17274–10–1 38402–11–8 855471–43–1 1421761–18–3 1382106–78–6 1421029–88–0 1382106–64–0 1938142–12–1 938142–13–2 1938142–14–3 1938142–15–4 1535169–81–3 Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic an alternative to § 721.63 respirator requirements may request to do so under § 721.30. Persons whose § 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 § 721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i), (ii), (iii), (iv), (vi), (ix), (g)(2)(i), (ii), (iii), (use respiratory protection or maintain workplace airborne concentrations at or below an 8-hour time-weighted average of 0.0184 mg/m3), (g)(2)(v), 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 § 721.80(k), (q) and (t). It is a significant new use to manufacture or process the substances other than for the processes described in the Order. acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, 3-chloro-, sodium salt (1:1). 2,3-dichloro-, sodium salt (1:1). 2,5-dichloro-, sodium salt (1:1). 3,5-dichloro-, sodium salt (1:1). 2,6-dichloro-, sodium salt (1:1). 3,4-dichloro-, sodium salt (1:1). 2,4-dichloro-, sodium salt (1:1). 2-chloro-4-fluoro-, sodium salt. 3-chloro-4-fluoro-, sodium salt. 5-chloro-2-fluoro-, sodium salt. 4-chloro-3-fluoro-, sodium salt. 4-chloro-2-fluoro-, sodium salt. 5-bromo-2-chloro-, sodium salt. 3-bromo-4-fluoro-, sodium salt. 2-bromo-5-fluoro-, sodium salt. 4-bromo-2-fluoro-, sodium salt. 4-bromo-3-fluoro-, sodium salt. (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 § 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 § 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. 34. Add § 721.11054 to subpart E to read as follows: ■ § 721.11054 acids Certain halogenated benzoic (a) The chemical substances listed in the Table of this section is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. TABLE—HALOGENATED BENZOIC ACIDS sradovich on DSK3GMQ082PROD with RULES2 PMN No. P–17–35 P–17–37 P–17–40 P–17–44 P–17–46 P–17–48 P–17–51 P–17–53 P–17–54 P–17–56 P–17–58 P–17–60 P–17–65 P–17–68 P–17–70 CAS No. .............................................................................. .............................................................................. .............................................................................. .............................................................................. .............................................................................. .............................................................................. .............................................................................. .............................................................................. .............................................................................. .............................................................................. .............................................................................. .............................................................................. .............................................................................. .............................................................................. .............................................................................. VerDate Sep<11>2014 21:28 Jul 31, 2018 Jkt 244001 PO 00000 Frm 00030 Chemical name 1201–31–6 433–97–6 2991–28–8 385–00–2 455–40–3 1583–58–0 455–86–7 121602–93–5 61079–72–9 446–17–3 4519–39–5 454–92–2 50–45–3 51–36–5 50–30–6 Fmt 4701 Sfmt 4700 Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, 2,3,4,5-tetrafluoro-. 2-(trifluoromethyl)-. 2,5-difluoro-. 2,6-difluoro-. 3,5-difluoro-. 2,4-difluoro-. 3,4-difluoro-. 3,4,5-trifluoro-. 2,3,4-trifluoro-. 2,4,5-trifluoro-. 2,3-difluoro-. 3-(trifluoromethyl)-. 2,3-dichloro-. 3,5-dichloro-. 2,6-dichloro-. E:\FR\FM\01AUR2.SGM 01AUR2 Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Rules and Regulations 37731 TABLE—HALOGENATED BENZOIC ACIDS—Continued PMN No. P–17–74 P–17–77 P–17–78 P–17–81 P–17–82 P–17–84 P–17–88 P–17–89 P–17–92 P–17–97 CAS No. .............................................................................. .............................................................................. .............................................................................. .............................................................................. .............................................................................. .............................................................................. .............................................................................. .............................................................................. .............................................................................. .............................................................................. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (v), (a)(3), (4), when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible, (a)(5) (respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor of at least 50, (a)(6) (particulate), (a)(6)(v), (vi), (b) (concentration set at 1.0%), 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 0.0184 mg/m3 as an 8-hour time weighted average. Persons who wish to pursue NCELs as Chemical name 2252–51–9 394–30–9 403–16–7 403–17–8 446–30–0 21739–92–4 11007–16–5 394–28–5 153556–42–4 112704–79–7 Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic an alternative to § 721.63 respirator requirements may request to do so under § 721.30. Persons whose § 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 § 721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i), (ii), (iii), (iv), (vi), (ix), (g)(2)(i), (ii), (iii), (use respiratory protection or maintain workplace airborne concentrations at or below an 8-hour time-weighted average of 0.0184 mg/m3), (g)(2)(v), 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 § 721.80(q) and (t). It is a significant new use to manufacture or process the substances other than for the processes described in the Order. acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, 2-chloro-4-fluoro-. 5-chloro-2-fluoro-. 3-chloro-4-fluoro-. 4-chloro-3-fluoro-. 4-chloro-2-fluoro-. 5-bromo-2-chloro-. 3-bromo-4-fluoro-. 2-bromo-5-fluoro-. 4-bromo-3-fluoro-. 4-bromo-2-fluoro-. (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 § 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 § 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. 35. Add § 721.11055 to subpart E to read as follows: ■ § 721.11055 Certain halogenated benzoic acids ethyl esters. (a) The chemical substances listed in the Table of this section is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. TABLE—HALOGENATED BENZOIC ACID ETHYL ESTERS sradovich on DSK3GMQ082PROD with RULES2 PMN No. CAS No. P–17–94 .............................................................................. P–17–95 .............................................................................. P–17–96 .............................................................................. P–17–98 .............................................................................. P–17–99 .............................................................................. P–17–100 ............................................................................ P–17–101 ............................................................................ P–17–102 ............................................................................ P–17–103 ............................................................................ P–17–104 ............................................................................ P–17–105 ............................................................................ P–17–114 ............................................................................ P–17–122 ............................................................................ P–17–123 ............................................................................ P–17–124 ............................................................................ P–17–125 ............................................................................ P–17–126 ............................................................................ P–17–127 ............................................................................ P–17–128 ............................................................................ P–17–129 ............................................................................ P–17–130 ............................................................................ P–17–131 ............................................................................ VerDate Sep<11>2014 21:28 Jul 31, 2018 Jkt 244001 PO 00000 Frm 00031 Chemical name 122894–73–9 583–02–8 577–62–8 19064–14–3 708–25–8 351354–50–2 351354–50–2 350–19–6 76008–73–6 1128–76–3 7335–25–3 137521–81–4 474709–71–2 144267–97–0 1130165–74–0 23233–33–2 4793–20–8 35112–27–7 203573–08–4 167758–87–4 773139–56–3 108928–00–3 Fmt 4701 Sfmt 4700 Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, acid, 2,3,4,5-tetrafluoro-, ethyl ester. 4-(trifluoromethyl)-, ethyl ester. 2-(trifluoromethyl)-, ethyl ester. 2,6-difluoro-, ethyl ester. 2,5-difluoro-, ethyl ester. 2,3,4-trifluoro-, ethyl ester. 2-bromo-5-fluoro-, ethyl ester. 3,5-difluoro-, ethyl ester. 5-bromo-2-chloro-, ethyl ester. 3-chloro-, ethyl ester. 2-chloro-, ethyl ester. 3-chloro-4-fluoro-, ethyl ester. 4-bromo-2-fluoro-, ethyl ester. 2-bromo-4,5-difluoro-, ethyl ester. 4-bromo-3-fluoro-, ethyl ester. 3-bromo-4-fluoro-, ethyl ester. 4-chloro-2-fluoro-, ethyl ester. 2,5-dichloro-, ethyl ester. 4-chloro-3-fluoro-, ethyl ester. 2-chloro-4-fluoro-, ethyl ester. 5-chloro-2-fluoro-, ethyl ester. 2,4-difluoro-, ethyl ester. E:\FR\FM\01AUR2.SGM 01AUR2 37732 Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Rules and Regulations TABLE—HALOGENATED BENZOIC ACID ETHYL ESTERS—Continued PMN No. sradovich on DSK3GMQ082PROD with RULES2 P–17–132 P–17–133 P–17–134 P–17–135 P–17–136 P–17–137 P–17–138 P–17–139 P–17–140 CAS No. ............................................................................ ............................................................................ ............................................................................ ............................................................................ ............................................................................ ............................................................................ ............................................................................ ............................................................................ ............................................................................ (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (v), (a)(3), (4), when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible, (a)(5) (respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor of at least 1000), (a)(6) (particulate), (a)(6)(v), (vi), (b) (concentration set at 1.0%), 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 0.0184 mg/m3 as an 8-hour time weighted average. Persons who wish to pursue NCELs as an alternative to § 721.63 respirator requirements may request to do so under § 721.30. Persons whose § 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 § 721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i), (ii), (iii), (iv), (vi), (ix), (g)(2)(i), (ii), (iii), (use respiratory protection or maintain workplace airborne concentrations at or below an 8-hour time-weighted average of 0.0184 mg/m3), (g)(2)(v), (g)(3)(i), (ii), (g)(4)(i), 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 VerDate Sep<11>2014 21:28 Jul 31, 2018 Jkt 244001 Chemical name 144267–96–9 495405–09–9 351354–41–1 76783–59–0 773134–65–9 81055–73–4 91085–56–2 56882–52–1 28394–58–3 Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic Benzoic specified in § 721.80(q) and (t). It is a significant new use to manufacture or process the substances other than for processes described in the Order. (iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) where N = 15 ppb. (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 § 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 § 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. ■ 36. Add § 721.11056 to subpart E to read as follows: § 721.11056 Neodymium aluminium alkyl polymer complexes (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as neodymium aluminium alkyl polymer complexes (PMN P–17– 198) 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 § 721.63(a)(1), (a)(2)(i), (ii), (iii), (a)(3), when determining which persons are reasonably likely to be exposed as required for § 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%), and (c). (ii) Hazard communication. Requirements as specified in § 721.72(a) PO 00000 Frm 00032 Fmt 4701 Sfmt 4700 acid, acid, acid, acid, acid, acid, acid, acid, acid, 3,4-difluoro-, ethyl ester. 3,4,5-trifluoro-, ethyl ester. 2,4,5-trifluoro-, ethyl ester. 3-(trifluoromethyl)-, ethyl ester. 2,3-difluoro-, ethyl ester. 2,6-dichloro-, ethyl ester. 3,5-dichloro-, ethyl ester. 2,4-dichloro-, ethyl ester. 3,4-dichloro-, ethyl ester. through (e) (concentration set 1.0%), (f), (g)(1)(ix), (The substance may react violently with water, (This substance may cause skin irritation and corrosion), (This substance may cause respiratory complications, irritation, and corrosion), (g)(2)(i), (ii), (iii), (When using this substance use in closed system to prevent any inhalation exposure), (When using this substance use skin and eye protection), 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 § 721.80(c) (It is a significant new use to process the substance in manner that results in inhalation exposure.), (f), and (p) (8 months). (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 § 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 § 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. ■ 37. Add § 721.11057 to subpart E to read as follows: § 721.11057 Fatty acid amide alkyl amine salts (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as fatty acid amide alkyl amine salts (PMN P–17–272, P–17–273, P–17–274, P–17–275, P–17–276 and P– 17–277) are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section E:\FR\FM\01AUR2.SGM 01AUR2 Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Rules and Regulations sradovich on DSK3GMQ082PROD with RULES2 do not apply to quantities of the substances after they have been reacted (cured). (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (iii), (iv), (a)(3). When determining which persons are reasonably likely to be exposed as required for § 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. (ii) Hazard communication. Requirements as specified in § 721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1) (skin irritation), (respiratory complication), (internal organ effect), (systemic effect), (sensitization), (g)(2)(i), (ii), (iii), (v), (g)(3)(i), (ii), (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. (iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k), and (y)(1). (iv) Release to water. Requirements as specified in § 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 VerDate Sep<11>2014 21:28 Jul 31, 2018 Jkt 244001 § 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 § 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. ■ 38. Add § 721.11058 to subpart E to read as follows: § 721.11058 Fatty acid amide alkyl amine salts (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as fatty acid amide alkyl amine salts (PMN P–17–278, P–17–279 and P–17–280) are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substances after they have been reacted (cured). (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (iii), (iv), (a)(3). When determining which persons are reasonably likely to be exposed as required for § 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. PO 00000 Frm 00033 Fmt 4701 Sfmt 9990 37733 (ii) Hazard communication. Requirements as specified in § 721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1) (skin irritation), (respiratory complication), (internal organ effect), (systemic effect), (sensitization), (g)(2)(i), (ii), (iii), (v), (g)(3)(i), (ii), (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. (iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k), and (y)(1). (iv) Release to water. Requirements as specified in § 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 § 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 § 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section. [FR Doc. 2018–15995 Filed 7–31–18; 8:45 am] BILLING CODE 6560–50–P E:\FR\FM\01AUR2.SGM 01AUR2

Agencies

[Federal Register Volume 83, Number 148 (Wednesday, August 1, 2018)]
[Rules and Regulations]
[Pages 37702-37733]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-15995]



[[Page 37701]]

Vol. 83

Wednesday,

No. 148

August 1, 2018

Part III





Environmental Protection Agency





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40 CFR Parts 9 and 721





Significant New Use Rules on Certain Chemical Substances; Final Rule

Federal Register / Vol. 83 , No. 148 / Wednesday, August 1, 2018 / 
Rules and Regulations

[[Page 37702]]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2017-0366; FRL-9970-23]
RIN 2070-AB27


Significant New Use Rules on Certain Chemical Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: EPA is promulgating significant new use rules (SNURs) under 
the Toxic Substances Control Act (TSCA) for 145 chemical substances 
which were the subject of premanufacture notices (PMNs). The chemical 
substances are subject to consent 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 145 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 1, 2018. For purposes of 
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on 
August 15, 2018.
    Written adverse comments on one or more of these SNURs must be 
received on or before August 31, 2018 (see Unit VI. of the 
SUPPLEMENTARY INFORMATION). If EPA receives written adverse comments on 
one or more of these SNURs before August 31, 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-2017-0366, 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 August 31, 2018 
are subject to the export notification provisions of TSCA section 12(b) 
(15 U.S.C. 2611(b)) (see Sec.  721.20), and must comply with the export 
notification requirements in 40 CFR part 707, subpart D.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or email. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as 
CBI and then identify electronically within the disk or CD-ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting 
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

II. Background

A. What action is the Agency taking?

    1. Direct Final Rule. EPA is promulgating these SNURs using direct 
final 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 
August 31, 2018 (see Unit VI. of the SUPPLEMENTARY INFORMATION), the

[[Page 37703]]

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 145 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) consent order.
     Information identified by EPA that would help characterize 
the potential health and/or environmental effects of the chemical 
substance in support of a request by the PMN submitter to modify the 
Order, or if a manufacturer or processor is considering submitting a 
SNUN for a significant new use designated by the SNUR. This information 
may include testing required in a TSCA section 5(e) Order to be 
conducted by the PMN submitter, as well as testing not required to be 
conducted but which would also help characterize the potential health 
and/or environmental effects of the PMN substance. Any recommendation 
for information identified by EPA was made based on EPA's consideration 
of available screening-level data, if any, as well as other available 
information on appropriate testing for the chemical substance. Further, 
any such testing identified by EPA that includes testing on vertebrates 
was made after consideration of available toxicity information, 
computational toxicology and bioinformatics, and high-throughput 
screening methods and their prediction models. EPA also recognizes that 
whether testing/further information is needed will depend on the 
specific exposure and use scenario in the SNUN. EPA encourages all SNUN 
submitters to contact EPA to discuss any potential future testing. See 
Unit VIII. for more information.
     CFR citation assigned in the regulatory text section of 
this rule. The regulatory text section of each rule specifies the 
activities designated as significant new uses. Certain new uses, 
including exceedance of production volume limits (i.e., limits on 
manufacture volume) and other uses designated in this rule, may be 
claimed as CBI. Unit IX. discusses a procedure companies may use to 
ascertain whether a proposed use constitutes a significant new use. 
These rules include 145 PMN substances that are subject to Orders under 
TSCA section 5(e)(1)(A)(ii)(I) where EPA determined that 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

[[Page 37704]]

to the actual NCEL concentration, the comprehensive NCELs provisions in 
TSCA section 5(e) Orders, which are modeled after Occupational Safety 
and Health Administration (OSHA) Permissible Exposure Limits (PELs) 
provisions, include requirements addressing performance criteria for 
sampling and analytical methods, periodic monitoring, respiratory 
protection, and recordkeeping. However, no comparable NCEL provisions 
currently exist in 40 CFR part 721, subpart B, for SNURs. Therefore, 
for these cases, the individual SNURs in 40 CFR part 721, subpart E, 
will state that persons subject to the SNUR who wish to pursue NCELs as 
an alternative to the Sec.  721.63 respirator requirements may request 
to do so under Sec.  721.30. EPA expects that persons whose Sec.  
721.30 requests to use 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 Numbers: P-14-472 and P-14-496

    Chemical names: Polyphosphoric acids, 2-[alkyl-1-oxo-2-propen-1-
yl)oxy]ethyl esters, compds. with N-(aminoiminomethyl)urea (generic) 
(P-14-472) and Polyphosphoric acids, 2-[(2-methyl-1-oxo-2-propen-1-
yl)oxy]ethyl esters, compds. with alkyl amino, polymers with Bu 
acrylate, N-(hydroxymethyl)propenamide and styrene (generic) (P-14-
496).
    CAS numbers: Not available.
    Effective date of TSCA section 5(e) Order: April 26, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) uses of the PMN substances are as a site-controlled 
intermediate (P-14-472) and a paper additive (P-14-496). Based on 
Structure Activity Relationship (SAR) analysis of test data on 
acrylates/methacrylates, and other structurally similar substances, 
there is potential for irritation and sensitization for P-14-472. For 
P-14-496 there is concern for sensitization based on the presence of 
formaldehyde and concern for irritation and lung effects from the 
surfactant properties of the substance. Further, based on SAR analysis 
of test data on analogous phosphates, EPA predicts toxicity to aquatic 
organisms may occur at concentrations that exceed 3 parts per billion 
(ppb) of P-14-472 and 4 ppb of P-14-496 in surface waters. The Order 
was issued under TSCA sections 5(a)(3)(B)(i) and 5(e)(1)(A)(i), based 
on a finding that the available information is insufficient to permit a 
reasoned evaluation of the human health effects of the PMN substances. 
Further, 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 human health and the environment. To 
protect against these risks, the Order requires:
    1. Submission of certain toxicity testing on the PMN substances 
prior to exceeding the confidential production volume limit as 
specified in the Order.
    2. Use of personal protective equipment to prevent dermal exposure.
    3. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the Safety Data Sheet (SDS).
    4. No release of the PMN substances resulting in surface water 
concentrations that exceed 3 ppb for P-14-472 and 4 ppb for P-14-496.
    5. No modification of the manufacturing process that results in 
inhalation exposure and no use involving application methods that 
generate a dust, mist, or aerosol.
    6. Use of the PMN substances only as a site-limited intermediate 
(P-14-472) and the confidential use specified in the Order (P-14-496).
    The SNUR would designate as a ``significant new use'' the absence 
of these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the fate and human health toxicity of the PMN 
substances may be potentially useful to characterize the effects of the 
PMN substances in support of a request by the PMN submitter to modify 
the Order, or if a manufacturer or processor is considering submitting 
a SNUN for a significant new use that will be designated by this SNUR. 
The submitter has agreed not to exceed the confidential production 
limit without performing a skin sensitization study and a 
biodegradation test on each substance. In addition, EPA has determined 
that the results of a pulmonary effects testing of the PMN substance 
may be potentially useful in characterizing the 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, 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 721.11024 (P-14-472) and 40 CFR 721.11025 (P-
14-496).

PMN Number: P-14-630

    Chemical name: Bismuth bromide iodide oxide.
    CAS number: 340181-06-8.
    Effective date of TSCA section 5(e) Order: May 10, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the 
substance will be used as a pigment for liquid coatings solvent based 
system; a pigment for powder coatings; and a pigment for polymer 
materials. Based on test data and physical/chemical properties of the 
PMN substance, as well as SAR analysis of analogous respirable, poorly 
soluble particulates, EPA identified concerns for lung effects, 
including fibrosis. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on insufficient 
information to make a reasoned evaluation and a finding that the 
substance may present an unreasonable risk of injury to human health. 
EPA assessed risks based on the specific manufacturing, processing, 
use, distribution/transportation, treatment and disposal processes, 
process equipment, engineering controls, and handling practices 
(including worker activities and cleaning procedures) described in the 
PMN. To protect against these risks, the Order requires:
    1. Submission of certain toxicity testing on the PMN substance 
prior to exceeding the confidential production volume limit as 
specified in the Order.
    2. Use of a National Institute for Occupational Safety and Health 
(NIOSH)-certified respirator with an Assigned Protection Factor (APF) 
of at least 10 (where there is a potential for inhalation exposures) or 
compliance with a New Chemical Exposure Limit (NCEL) of 2.4 milligram/
meter\3\ (mg/m\3\) as an 8-hour time-weighted average.
    3. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    4. No use of the substance in a consumer product that generates a 
dust, mist, or aerosol.
    The SNUR will designate as a ``significant new use'' the absence of 
these protective measures, and any use to vary or alter, the 
manufacturing, processing, use, distribution/transportation, treatment 
and disposal processes, process equipment, engineering controls, and 
handling practices (including worker activities and cleaning 
procedures) described in the PMN in such a way as to change the 
magnitude of inhalation exposure.

[[Page 37705]]

    Potentially useful information: EPA has determined that certain 
information about the human health toxicity of the PMN substance may be 
potentially useful to characterize the effects of the PMN substance 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 target organ toxicity testing. In addition, EPA has 
determined that the results of a chronic toxicity/carcinogenicity test 
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, 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 721.11026.

PMN Number: P-15-450

    Chemical name: Aluminum cobalt lithium nickel oxide.
    CAS number: 177997-13-6.
    Effective date of TSCA section 5(e) Order: March 23, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the 
substance will be used as a mixed metal oxide for batteries. Based on 
test data on the PMN substance, EPA identified concerns for spleen and 
kidney toxicity. Based on physical/chemical properties of the PMN 
substance, as well as SAR analysis of analogous respirable, poorly 
soluble particulates, EPA identified concerns for lung effects based on 
lung overload. Based on the crystalline structure of the PMN substance, 
EPA identified concern for lung carcinogenicity. The Order was issued 
under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on 
insufficient information to make a reasoned evaluation and a finding 
that the substance may present an unreasonable risk of injury to human 
health. EPA assessed risks based on the specific manufacturing, 
processing, use, distribution/transportation, treatment and disposal 
processes, process equipment, engineering controls, and handling 
practices (including worker activities and cleaning procedures) 
described in the PMN. To protect against these risks, the Order 
requires:
    1. Submission of certain toxicity testing on the PMN substance 
prior to exceeding the time limit as specified in the Order.
    2. Use of personal protective equipment including impervious gloves 
and protective clothing (where there is a potential for dermal 
exposures).
    3. Use of a NIOSH-certified respirator with an APF of at least 
1,000 (where there is a potential for inhalation exposure) or 
compliance with a NCEL of 0.000092 ppm as an 8-hour time-weighted 
average.
    4. Use of the chemical transfer processes and air ventilation 
processes described in the PMN and the exposure monitoring requirements 
described in the Order.
    5. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    6. Disposal of the PMN substance by landfill only. Air releases are 
limited by processes described in the PMN, including filtering through 
a high-efficiency particulate air filter with an efficiency rate of 
99.99%.
    7. No domestic manufacture of the PMN substance.
    The SNUR will designate as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the human health toxicity of the PMN substance may be 
potentially useful to characterize the effects of the PMN substance 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 time limit without performing specific 
target organ toxicity testing and carcinogenicity testing. In addition, 
EPA has determined that the results of medical monitoring of the 
workers exposed to the substance during manufacturing, processing, and 
use may be potentially useful in characterizing the health effects of 
the PMN substance. Although the Order does not require this medical 
monitoring, the Order's restrictions on manufacture, processing, 
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 721.11027.

PMN Number: P-15-705

    Chemical name: Alkylarylamine (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: May 11, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the 
substance will be used as a chemical intermediate and as an additive 
and octane booster in aviation fuels.
    Based on test data on the PMN substance, EPA has identified 
concerns for dermal irritation, developmental toxicity, and blood 
effects. Based on test data on analogous anilines, EPA has identified 
concerns for cardiovascular, eye, liver, kidney, and pulmonary effects, 
as well as bladder cancer. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on insufficient 
information to make a reasoned evaluation and a finding that the 
substance may present an unreasonable risk of injury to human health. 
To protect against these risks, the Order requires:
    1. Submission of certain toxicity testing on the PMN substance 
prior to exceeding the confidential production volume limit as 
specified in the Order.
    2. Use of personal protective equipment including impervious 
gloves, full body chemical protective clothing and chemical goggles or 
equivalent eye protection (where there is a potential for dermal 
exposure).
    3. Use of a NIOSH-certified respirator with an APF of at least 
1,000 (where there is a potential for inhalation exposure) or 
compliance with a NCEL of 0.48 mg/m\3\ as an 8-hour time-weighted 
average. (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. No use of the substance in a consumer product.
    5. No use other than as a chemical intermediate or as an additive 
and octane booster in aviation fuels.
    6. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    7. No release of the PMN substance resulting in surface water 
concentrations that exceed 1 ppb.
    The SNUR will designate as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the human health and aquatic 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

[[Page 37706]]

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 target organ toxicity testing and a 
chronic aquatic toxicity test.
    CFR citation: 40 CFR 721.11028.

PMN Numbers: P-15-706 and P-15-707

    Chemical names: Aliphatic N-alkyl urea polymer containing 
cyclohexyl groups and trimethoxy silanes (generic) (P-15-706) and 
Aliphatic N-alkyl urea polymer containing aspartic ester groups and 
trimethoxy silanes (generic) (P-15-707).
    CAS numbers: Not available.
    Effective date of TSCA section 5(e) Order: April 26, 2017.
    Basis for TSCA section 5(e) Order: The PMNs state that the generic 
use of the substances will be as ingredients for multipurpose exterior 
coatings. Based on SAR analysis on reactive methoxy silane moieties, 
EPA has identified concerns for irritation to lungs, eyes, and mucus 
membranes. There are also concerns for acute toxicity, neurotoxicity, 
and developmental toxicity based on the presence of methanol, and for 
sensitization if there are residual isocyanates. The Order was issued 
under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on 
insufficient information to make a reasoned evaluation and a finding 
that the substances may present an unreasonable risk of injury to human 
health. To protect against these risks, the Order requires:
    1. Submission of certain toxicity testing on the PMN substance 
prior to exceeding the production limit as specified in the Order.
    2. Use of personal protective equipment including impervious gloves 
(where there is a potential for dermal exposure).
    3. Use of a NIOSH-certified respirator with an APF of at least 10 
(where there is a potential for inhalation exposure) or compliance with 
a NCEL of 0.9 mg/m\3\ as an 8-hour time-weighted average. (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 human health precautionary statements on each label and in 
the SDS.
    5. No manufacture beyond an annual production volume of 250,000 
kilograms (kg).
    6. Manufacture of the PMN substances to contain no more than 0.1% 
residual isocyanate by weight.
    7. No uses of the substances other than allowed in the Order.
    8. No use of the substances in a consumer product.
    The SNUR will designate as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the human health toxicity of the PMN substances may 
be potentially useful to characterize the effects of the PMN substances 
in support of a request by the PMN submitter to modify the Order, or if 
a manufacturer or processor is considering submitting a SNUN for a 
significant new use that will be designated by this SNUR. The submitter 
has agreed not to exceed the confidential production limit without 
performing specific target organ toxicity testing for P-15-706.
    CFR citation: 40 CFR 721.11029 (P-15-706) and 40 CFR 721.11030 (P-
15-707).

PMN Numbers: P-16-273 and P-16-274

    Chemical names: Alkyl heteromonocycle, polymer with 
heteromonocycle, carboxyalkyl alkyl ethers (generic).
    CAS numbers: Not available.
    Effective date of TSCA section 5(e) Order: April 25, 2017.
    Basis for TSCA section 5(e) Order: The PMNs state that the generic 
(non-confidential) use of the substances will be as ingredients in 
metalworking fluids. Based on submitted test data for P-16-273 and 
structurally similar surfactants, EPA has identified concerns for 
dermal sensitization and irritation and lung effects. Based on 
submitted toxicity data for P-16-273, EPA estimates toxicity to aquatic 
organisms may occur for both PMNs at concentrations that exceed 10 ppb 
of the PMN substances 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 
insufficient information to make a reasoned evaluation and a finding 
that the substances may present an unreasonable risk of injury to human 
health and the environment. To protect against these risks, the Order 
requires:
    1. No domestic manufacture of the PMN substances.
    2. Use of the PMN substances only: (i) For the confidential uses 
specified in the Order, (ii) at a concentration no greater than 3% of 
the metalworking fluid, and (iii) used only in closed metalworking 
systems as specified in the PMNs with no modifications in the process 
that would result in worker inhalation exposure.
    3. Use of personal protective equipment including impervious gloves 
(where there is a potential for dermal exposure).
    4. No release of the PMN substances resulting in surface water 
concentrations that exceed 10 ppb.
    The SNUR will designate as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the fate and toxicity of the PMN substances may be 
potentially useful to characterize the health and environmental effects 
of the PMN substances in support of a request by the PMN submitter to 
modify the 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 biodegradation test of the PMN substances may be 
potentially useful in characterizing the health and environmental 
effects of the PMN substances. Although the Order does not require 
these tests, the Order's restrictions on manufacture, processing, 
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 721.11031.

PMN Number: P-16-289

    Chemical name: Benzene dicarboxylic acid, polymer with alkane dioic 
acid and aliphatic diamine (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: March 24, 2017.
    Basis for TSCA section 5(e) Order: The PMN states the substance 
will be used as an extrusion compounding molding resin. Based on test 
data on analogous high molecular weight polymers, EPA has concerns for 
lung effects, which includes lung overload. The Order was issued under 
TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on 
insufficient information to make a reasoned evaluation and a finding 
that the substance may present an unreasonable risk of injury to human 
health. To protect against these risks, the Order requires:
    1. Submission of particle size testing on the PMN substance prior 
to exceeding the time limit as specified in the Order.

[[Page 37707]]

    2. Manufacture of the PMN substance such that the solid particle 
form has a particle size distribution where less than 1% of the 
particles are less than 10 microns.
    The SNUR will designate as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the physical/chemical characteristics 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 manufacture beyond a certain 
time period without measuring the particle size distribution to 
characterize the fraction of the dry particle PMN substance less than 
10 microns. In addition, EPA has determined that the results of 
specific target organ toxicity testing 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, 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 721.11032.

PMN Number: P-16-322

    Chemical name: Manganese cyclic (tri)amine chloride complex 
(generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: April 25, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance will be as a pulp bleaching 
catalyst. Based on test data on an analog, EPA has identified concerns 
for kidney, blood, and thyroid effects, immunotoxicity, reproductive 
and developmental toxicity, and neurotoxicity. Based on test data on 
the PMN substance, EPA estimates that toxicity to aquatic organisms may 
occur at concentrations that exceed 18 ppb of the PMN substance 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 insufficient 
information to make a reasoned evaluation and a finding that the 
substance may present an unreasonable risk of injury to human health 
and the environment. To protect against these risks, the Order 
requires:
    1. Submission of certain toxicity testing on the PMN substance 
prior to exceeding the confidential production volume limit as 
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 NIOSH-certified respirator with an APF of at least 25 
(where there is a potential for inhalation exposure) or compliance with 
a NCEL of 1.2 ppm as an 8-hour time-weighted average. (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 human health precautionary statements on each label and in 
the SDS.
    5. No domestic manufacture of the PMN substance.
    6. Process and use of the PMN substance only for the confidential 
uses and formulation percentage specified in the Order.
    7. No release of the PMN substance resulting in surface water 
concentrations that exceed 18 ppb.
    The SNUR will designate as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the human health and aquatic 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 target organ toxicity testing, 
reproductive/developmental toxicity testing; and chronic aquatic 
toxicity testing.
    CFR citation: 40 CFR 721.11033.

PMN Numbers: P-16-338, P-16-339, P-16-439, and P-16-440

    Chemical names: Xanthylium, (sulfoaryl)-bis [(substituted aryl) 
amino]-, sulfo derivs., inner salts, metal salts (generic) (P-16-338); 
Substituted triazinyl metal salt, diazotized, coupled with substituted 
pyridobenzimidazolesulfonic acids, substituted 
pyridobenzimidazolesulfonic acids, diazotized substituted 
alkanesulfonic acid, diazotized substituted aromatic sulfonate, 
diazotized substituted aromatic sulfonate, metal salts (generic) (P-16-
339); Carbon black, (organic acidic carbocyclic)-modified, inorganic 
salt (generic) (P-16-439); and Carbon black, (organic acidic 
carbocyclic)-modified, metal salt (generic) (P-16-440).
    CAS numbers: Not available.
    Effective date of TSCA section 5(e) Order: April 11, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) uses of the PMN substances will be as dyestuffs (P-
16-0338 and P-16-0339) and as coloring agents (P-16-0439 and P-16-
0440). Based on physical/chemical properties of the PMN substances and 
test data on analogous poorly respirable particles, EPA has identified 
concerns for irritation to the eyes, lungs, and mucous membranes, and 
lung effects. Further, based on SAR analysis of test data on analogous 
dyes, EPA predicts toxicity to aquatic organisms may occur at 
concentrations that exceed 200 ppb of the PMN substances 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 insufficient information to make a reasoned 
evaluation and a finding that the substances may present an 
unreasonable risk of injury to human health and the environment. To 
protect against these risks, the Order requires:
    1. No manufacture of the PMN substances beyond the confidential 
annual production volume specified in the Order.
    2. No domestic manufacture of the PMN substances.
    3. Import the PMN substances only according to the terms specified 
and for the confidential uses specified in the Order.
    4. No release of the PMN substances to surface waters.
    The SNUR will designate as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the fate, human health toxicity, and aquatic toxicity 
of the PMN substances may be potentially useful to characterize the 
effects of the PMN substances in support of a request by the PMN 
submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that will be 
designated by this SNUR. EPA has determined that the results of a 
biodegradation test, specific target organ toxicity testing, and acute 
and chronic aquatic toxicity testing of the PMN

[[Page 37708]]

substances may be potentially useful in characterizing the health and 
environmental effects of the PMN substances. Although the Order does 
not require these tests, the Order's restrictions on manufacture, 
processing, 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 citations: 40 CFR 721.11034 (P-16-338), 40 CFR 721.11035 (P-16-
339), 40 CFR 721.11036 (P-16-439), and 40 CFR 721.11037 (P-16-440).

PMN Number: P-16-350

    Chemical name: Polyaralkyl aryl ester of methacrylic acid 
(generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: March 31, 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 reactant. 
Based on test data on methacrylate moieties, EPA has identified 
concerns for irritation and sensitization based on analogy to 
methacrylates. Based on SAR analysis of test data on structurally 
similar respirable surfactants, EPA has identified concerns for lung 
effects. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 
5(e)(1)(A)(ii)(I), based on insufficient information to make a reasoned 
evaluation and a finding that the substance may present an unreasonable 
risk of injury to human health. To protect against these risks, the 
Order requires:
    1. Use of personal protective equipment including impervious gloves 
(where there is a potential for dermal exposure).
    2. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    3. Manufacture of the PMN substance such that it is not less than 
the minimum average molecular weight identified in the Order and does 
not contain more than the maximum weight percent of low molecular 
weight species below 1,000 Daltons.
    4. Use of the PMN substance only for the confidential use specified 
in the Order.
    The SNUR will designate as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the toxicity of the PMN substance may be potentially 
useful to characterize the health 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, 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 721.11038.

PMN Number: P-16-352

    Chemical names: Phenol, 2-[[[3-(octyloxy)propyl]imino]methyl]- (P-
16-352, chemical A) and Phenol, 2-[[[3-(decyloxy)propyl]imino]methyl]- 
(P-16-352, chemical B).
    CAS numbers: 1858221-49-4 (P-16-352, chemical A) and 1858221-50-7 
(P-16-352, chemical B).
    Effective date of TSCA section 5(e) Order: April 21, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the PMN 
substances will be used as co-catalysts in the manufacturing of release 
coatings for producing papers and films at a concentration of 1% or 
less. Based on SAR analysis of test data on analogous phenols, EPA has 
identified concerns for respiratory and dermal irritation and 
developmental toxicity. In addition, EPA has identified concerns for 
liver toxicity and reproductive effects based on the hydrolysis product 
o-hydroxybenzaldehyde. Further, based on SAR analysis of test data on 
analogous phenols, EPA predicts toxicity to aquatic organisms may occur 
at concentrations that exceed 1 ppb of the PMN substances 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 insufficient information to make a reasoned 
evaluation and a finding that the substances may present an 
unreasonable risk of injury to human health and the environment. To 
protect against these risks, the Order requires:
    1. Submission of certain toxicity testing on the PMN substance 
prior to exceeding the confidential production volume limit as 
specified in the Order.
    2. Use of personal protective equipment including impervious gloves 
(where there is a potential for dermal exposure).
    3. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    4. No domestic manufacture of the PMN substances.
    5. No manufacture of the PMN substances beyond an annual production 
volume of 250 kg/yr.
    6. No use of the PMN substances in application methods that 
generate a dust, mist, or aerosol.
    7. No release of the PMN substance resulting in surface water 
concentrations that exceed 1 ppb.
    The SNUR will designate as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the human health and aquatic 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 target organ toxicity, reproductive/
developmental toxicity, and acute aquatic toxicity testing.
    CFR citations: 40 CFR 721.11039 (P-16-352, chemical A) and 40 CFR 
721.11040 (P-16-352, chemical B).

PMN Number: P-16-358

    Chemical name: Alkyl phenol (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: April 24, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the 
substance will be used as a chemical intermediate. Based on SAR 
analysis of test data on analogous phenols, EPA has identified concerns 
for developmental toxicity. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on insufficient 
information to make a reasoned evaluation and a finding that the 
substance may present an unreasonable risk of injury to human health. 
To protect against these risks, the Order requires:
    1. Submission of certain toxicity testing on the PMN substance 
prior to exceeding the confidential production volume limit as 
specified in the Order.
    2. Use of personal protective equipment including impervious gloves 
(where there is a potential for dermal exposure).

[[Page 37709]]

    3. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    4. Use of the PMN substance only as a chemical intermediate.
    5. No manufacture, process, or use of the PMN substance in any 
manner or method that generates a dust, mist, or aerosol or in a non-
enclosed process.
    6. No release of the PMN substance to surface waters.
    The SNUR will designate as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the human health toxicity of the PMN substance may be 
potentially useful to characterize the effects of the PMN substance 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 will be designated by this SNUR. The submitter has 
agreed not to exceed the confidential production limit without 
performing specific target organ toxicity and reproductive/
developmental toxicity tests.
    CFR citation: 40 CFR 721.11041.

PMN Number: P-16-364

    Chemical name: Nitrile-butadiene-acrylate terpolymers (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: March 31, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance will be as a chemical 
intermediate. Based on SAR analysis of test data on structurally 
similar respirable particles, EPA has identified concerns for lung 
effects, including lung overload. The Order was issued under TSCA 
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on insufficient 
information to make a reasoned evaluation and a finding that the 
substance may present an unreasonable risk of injury to human health. 
To protect against these risks, the Order requires:
    1. Use of the PMN substance only as a site-limited chemical 
intermediate.
    2. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    3. No manufacture, process, or use of the PMN substance if it 
contains more than 5% of the particle size distribution less than 10 
microns.
    The SNUR will designate as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the toxicity of the PMN substance may be potentially 
useful to characterize the 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 of the PMN substance 
may be potentially useful in characterizing the health effects of the 
PMN substance. Although the Order does not require this test, the 
Order's restrictions on manufacture, processing, 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 721.11042.

PMN Number: P-16-399

    Chemical name: Starch, polymer with 2-propenoic acid, potassium 
salt, oxidized.
    CAS number: 1638117-09-5.
    Effective date of TSCA section 5(e) Order: April 6, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the 
substance will be used as an agricultural soil amendment for field 
crops, agricultural soil amendment for turf applications and direct 
soil injection with fertilizers, and a compound to be used in 
preparation of advanced seed coatings. Based on SAR analysis of test 
data on structurally similar respirable particles, EPA has identified 
concerns for lung effects, including lung overload. The Order was 
issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), 
based on insufficient information to make a reasoned evaluation and a 
finding that the substance may present an unreasonable risk of injury 
to human health. The Order was also issued under TSCA sections 
5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II), based on a finding that the 
substance that the substance is or will be produced in substantial 
quantities and that the substance either enters or may reasonably be 
anticipated to enter the environment in substantial quantities, or 
there is or may be significant (or substantial) human exposure to the 
substance. To protect against these risks, the Order requires:
    1. Submission of certain toxicity testing on the PMN substance 
prior to exceeding the time limit as specified in the Order.
    2. Use of personal protective equipment including impervious gloves 
(where there is a potential for dermal exposure).
    3. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    4. Manufacture of the substance with a particulate size greater 
than 30 microns.
    The SNUR will designate as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the toxicity of the PMN substance may be potentially 
useful to characterize the health and environmental effects of the PMN 
substance 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 manufacture beyond a certain time limit 
without performing an acute aquatic toxicity test. In addition, EPA has 
determined that the results of specific target organ toxicity testing 
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, 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 721.11043.

PMN Number: P-16-430

    Chemical name: Pentanedioic acid, 2-methyl-.
    CAS number: 617-62-9.
    Effective date of TSCA section 5(e) Order: May 17, 2017.
    Basis for TSCA section 5(e) Order: The PMN states the generic (non-
confidential) use of the substance will be as a filler. Based on test 
data on the PMN substance, EPA has identified concerns for systemic and 
reproductive toxicity. Based on structural analysis on the acid groups 
and test data, EPA has identified concerns for dermal and respiratory 
irritation. Further, based on test data on the PMN substance and test 
data on analogous neutral organics, EPA predicts toxicity to aquatic 
organisms may occur at concentrations that exceed 14 ppb of the PMN 
substance 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 insufficient 
information to make a reasoned evaluation and a finding that the

[[Page 37710]]

substance may present an unreasonable risk of injury to human health 
and the environment. EPA assessed risks based on the specific 
processing, use, distribution/transportation, treatment and disposal 
processes, process equipment, engineering controls, and handling 
practices (including worker activities and cleaning procedures) 
described in the PMN. To protect against these risks, the Order 
requires:
    1. Use of personal protective equipment including impervious gloves 
(where there is a potential for dermal exposure).
    2. Use of a NIOSH-certified respirator with an APF of at least 10 
(where there is a potential for 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.)
    3. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    4. No domestic manufacture of the PMN substance.
    5. Import of the PMN substance at or below the maximum 
concentration specified in the Order.
    6. No release of the PMN substance resulting in surface water 
concentrations that exceed 14 ppb.
    The SNUR will designate as a ``significant new use'' the absence of 
these protective measures, and use of the chemical substance to vary or 
alter the processing, use, distribution, engineering controls, and 
handling practices described in the Order in such a way as to change 
the magnitude of inhalation exposure.
    Potentially useful information: EPA has determined that certain 
information about the human health toxicity of the PMN substance may be 
potentially useful to characterize the effects of the 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 
of the PMN substance may be potentially useful in characterizing the 
health effects of the PMN substance. Although the Order does not 
require this test, the Order's restrictions on manufacture, processing, 
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.
    CFR citation: 40 CFR 721.11044.

PMN Number: P-16-495

    Chemical name: 2-Pentanol, 4-methyl-, reaction products with 
phosphorus oxide (P2O5), compounds with alkylamine (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: April 25, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
use (non-confidential) of the substance will be as a lubricant 
additive. Based on test data on the substance, EPA has identified 
concerns for systemic effects, sensitization and irritation to the eyes 
and skin. Based on physical/chemical properties, EPA has concerns for 
lung effects, including lung surfactancy. Further, based on test data 
on analogous aliphatic amines for the cation and neutral organics for 
the anion as well as test data on the PMN substance, EPA predicts 
toxicity to aquatic organisms may occur at concentrations that exceed 
200 ppb of the PMN substance 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 
insufficient information to make a reasoned evaluation and a finding 
that the substance may present an unreasonable risk of injury to human 
health and the environment. To protect against these risks, the Order 
requires:
    1. Submission of certain toxicity testing on the PMN substance 
prior to exceeding the confidential production volume limit as 
specified in the Order.
    2. Use of personal protective equipment (where there is a potential 
for dermal exposure).
    3. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    4. No manufacture in any manner or method that results in 
inhalation exposure.
    5. No use of the PMN substance in an application method that 
generates a vapor, mist, or aerosol.
    6. No release of the PMN substance resulting in surface water 
concentrations that exceed 200 ppb.
    The SNUR will designate as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the human health and aquatic toxicity of the PMN 
substance may be potentially useful to characterize the effects of the 
PMN substance 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 chronic 
aquatic toxicity tests. In addition, EPA has determined that the 
results of specific target organ toxicity testing 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, 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 721.11045.

PMN Number: P-16-513

    Chemical name: Hydroxy alkylbiphenyl (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: May 2, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the 
substance will be used as a chemical intermediate. Based on test data 
on an analog, EPA has identified concerns for developmental toxicity, 
systemic toxicity, blood effects, and corrosion of the skin, eyes, and 
mucous membranes. Further, based on SAR analysis of test data on 
analogous amides, EPA predicts toxicity to aquatic organisms may occur 
at concentrations that exceed 17 ppb of the PMN substances 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 insufficient information to make a reasoned 
evaluation and a finding that the substances may present an 
unreasonable risk of injury to human health and the environment. To 
protect against these risks, the Order requires:
    1. Submission of certain toxicity testing on the PMN substance 
prior to exceeding the confidential production volume limit as 
specified in the Order.
    2. Use of personal protective equipment (where there is a potential 
for dermal exposure).
    3. Use of a NIOSH-certified respirator with an APF of at least 50 
(where there is a potential for 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. Use of the PMN substance only as a chemical intermediate.

[[Page 37711]]

    5. No release of the PMN substance resulting in surface water 
concentrations that exceed 17 ppb.
    The SNUR will designate as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the human health and aquatic 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 target organ toxicity and 
reproductive/developmental toxicity testing. In addition, EPA has 
determined that the results of acute aquatic toxicity tests may be 
potentially useful in characterizing the environmental effects of the 
PMN substance. Although the Order does not require these additional 
tests, the Order's restrictions on manufacture, processing, 
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 721.11046.

PMN Numbers: P-16-534, P-16-535, and P-16-536

    Chemical names: Alkyl alkenoic acid, polymer with 
alkenylcarbomonocycle telomer with substituted alkanoic acid hydroxyl 
alkyl substituted alkenyl substituted alkyl ester, polyalkylene glycol 
alkyl ether alkyl alkenoate, dialkylene glycol diheteromonocyclic ether 
and alkylcarbomonocyclic alkenoate, metal salt (generic) (P-16-534); 
Alkyl alkenoic acid, polymer with alkenylcarbomonocycle telomer with 
substituted alkanoic acid hydroxyl alkyl substituted alkenyl 
substituted alkyl ester, alkanediol diheteromonocyclic ether, 
polyalkylene glycol alkyl ether alkyl alkenoate and 
alkylcarbomonocyclic alkenoate, metal salt (generic) (P-16-535); and 
Alkyl alkenoic acid, polymer with bis heteromonocyclic substituted 
alkyl carbomonocycle, alkenylcarbomonocycle telomer with substituted 
alkanoic acid hydroxyl alkyl substituted alkenyl substituted alkyl 
ester, polyalkylene glycol alkyl ether alkyl alkenoate and 
alkylcarbomonocyclic alkenoate, metal salt (generic) (P-16-536).
    CAS numbers: Not available.
    Effective date of TSCA section 5(e) Order: April 4, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substances will be a component of ink. 
Based on test data on structurally similar respirable particles, EPA 
has identified concerns for lung effects if inhaled, based on lung 
overload. In addition, EPA has identified ecotoxicity concerns for the 
substances if made with an acid component exceeding 20% of the 
molecular weight due potential for increased absorption and solubility. 
The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 
5(e)(1)(A)(ii)(I), based on insufficient information to make a reasoned 
evaluation and a finding that the substances may present an 
unreasonable risk of injury to human health and the environment. To 
protect against these risks, the Order requires:
    1. Manufacture of the PMN substances such that the minimum average 
molecular weight is 1,800 daltons and the carboxylic acid content does 
not exceed 20%.
    2. No domestic manufacture of the PMN substances.
    3. Process or use of the PMN substances only for the use specified 
in the Order.
    The SNUR will designate as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the human health and aquatic toxicity of the PMN 
substances may be potentially useful to characterize the effects of the 
substances in support of a request by the PMN submitter to modify the 
Order, or if a manufacturer or processor is considering submitting a 
SNUN for a significant new use that will be designated by this SNUR. 
EPA has determined that the results of specific target organ toxicity 
testing and an acute aquatic toxicity test of the PMN substances may be 
potentially useful in characterizing the health and environmental 
effects of the PMN substances. Although the Order does not require 
these tests, the Order's restrictions on manufacture, processing, 
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 citations: 40 CFR 721.11047 (P-16-534), 40 CFR 721.11048 (P-16-
535), and 40 CFR 721.11049 (P-16-536).

PMN Numbers: P-16-549, P-16-550, P-16-551, P-16-553, P-16-555, P-16-
556, P-16-557, P-16-558, P-16-560, P-16-561, P-16-562, P-16-563, P-16-
564, P-16-565, and P-16-567

    Chemical names: Alkaline functionalized methacrylate-substituted 
polymer (generic) (P-16-549, P-16-550, and P-16-551); Quatenary 
alkylamine functionalized methacrylate-substituted polymer (generic) 
(P-16-553); Neutral alcohol functionalized methacrylate-substituted 
polymer (generic) (P-16-555 and P-16-556); Neutral alkyl salt 
functionalized methacrylate-substituted polymer (generic) (P-16-557, P-
16-558, and P-16-560); Acid functionalized methacrylate-substituted 
polymer (generic) (P-16-561, P-16-562, P-16-563, P-16-564, and P-16-
565); and Alkylamine functionalized methacrylate-substituted polymer 
(generic) (P-16-567).
    CAS numbers: Not available.
    Effective date of TSCA section 5(e) Order: May 2, 2017.
    Basis for TSCA section 5(e) Order: The PMN states the substances 
will be use as crosslinked resins for chromatographic separation of 
biomolecules and biocatalysts. Based on test data on structurally 
similar respirable particles, EPA has identified concerns for lung 
effects, including lung overload. EPA has also identified irritation 
concerns for skin and eyes. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on insufficient 
information to make a reasoned evaluation and a finding that the 
substances may present an unreasonable risk of injury to human health. 
To protect against these risks, the Order requires:
    1. Use of personal protective equipment including impervious gloves 
(where there is a potential for dermal exposure).
    2. Manufacture of the PMN substances only in the physical form of 
spherical beads and with less than 0.1% below a particle size of 10 
microns.
    3. No domestic manufacture of the PMN substances.
    4. Process or use of the PMN substances only for the uses specified 
in the Order.
    The SNUR will designate as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the human health toxicity of the PMN substances may 
be potentially useful to characterize the effects of the substances in 
support of a request by the PMN submitter to modify the Order, or

[[Page 37712]]

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 
of the PMN substances may be potentially useful in characterizing the 
health effects of the PMN substances. Although the Order does not 
require this testing, the Order's restrictions on manufacture, 
processing, 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 citations: 40 CFR 721.11050.

PMN Number: P-16-579

    Chemical name: Waste plastics, poly(ethylene terephthalate), 
depolymd. with polypropylene glycol ether with glycerol (3:1), polymers 
with alkenoic and alkanoic acids (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: March 13, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the 
substance will be used as an ultraviolet curable coating resin. Based 
on test data on similar structural moieties, EPA has identified 
concerns for dermal and respiratory sensitization and irritation of 
mucous membranes. In addition, EPA has identified human health and 
environmental concerns for the substance if made with lower molecular 
weight due potential for increased absorption and solubility. The Order 
was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), 
based on insufficient information to make a reasoned evaluation and a 
finding that the substances may present an unreasonable risk of injury 
to human health and the environment. To protect against these risks, 
the Order requires:
    1. Use of personal protective equipment including gloves and 
protective clothing (where there is a potential for dermal exposure).
    2. Use of a NIOSH-certified full face respirator with an APF of at 
least 50 (where there is a potential for 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.)
    3. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    4. No manufacture of the PMN substance with an average molecular 
weight less than 1,100 Daltons.
    5. Use of the PMN substance only as an ultraviolet curable coating 
resin.
    The SNUR will designate 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 human health and 
aquatic toxicity of the PMN substance may be potentially useful to 
characterize the effects of the 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 
measurement of certain physical-chemical properties, the results of 
specific target organ toxicity, reproductive/developmental toxicity, 
sensitization, and acute and chronic aquatic toxicity testing may be 
potentially useful in characterizing the health and environmental 
effects of the PMN substances. Although the Order does not require 
these tests, the Order's restrictions on manufacture, processing, 
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 721.11051.

PMN Number: P-17-32

    Chemical name: 1,3,5-Naphthalenetrisulfonic acid.
    CAS number: 6654-64-4.
    Effective date of TSCA section 5(e) Order: March 22, 2017.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance is for monitoring of oil/gas 
well performance. Based on test data on an analog and physical/chemical 
properties of the PMN substance, EPA has identified concerns for dermal 
and respiratory irritation, developmental toxicity, and blood effects. 
The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 
5(e)(1)(A)(ii)(I), based on insufficient information to make a reasoned 
evaluation and a finding that the substance may present an unreasonable 
risk of injury to human health. To protect against these risks, the 
Order requires:
    1. Submission of certain toxicity testing on the PMN substance 
prior to exceeding the confidential production volume limit as 
specified in the Order.
    2. Use of personal protective equipment including NIOSH-approved 
respirator (APF 50) and impervious gloves (where there is a potential 
for inhalation or dermal 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.)
    3. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    4. No manufacture or processing of the PMN substance beyond a 
confidential annual production volume specified in the Order.
    5. No manufacture, processing, or use using application methods 
that intentionally generate a vapor, mist or aerosol.
    The SNUR will designate as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the human health toxicity of the PMN substance may be 
potentially useful to characterize the effects of the PMN substance 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 target organ toxicity and developmental toxicity 
testing.
    CFR citation: 40 CFR 721.11052.

PMN Numbers: P-17-33, P-17-34, P-17-36, P-17-38, P-17-39, P-17-41, P-
17-42, P-17-43, P-17-45, P-17-47, P-17-50, P-17-52, P-17-55, P-17-57, 
P-17-59, P-17-61, P-17-62, P-17-63, P-17-64, P-17-66, P-17-67, P-17-69, 
P-17-71, P-17-72, P-17-73, P-17-75, P-17-76, P-17-79, P-17-80, P-17-83, 
P-17-85, P-17-87, P-17-90, P-17-91, P-17-93

[[Page 37713]]



                     Chemical Names and CAS Numbers
------------------------------------------------------------------------
                     Chemical name                           CAS No.
------------------------------------------------------------------------
Benzoic acid, 2-fluoro-, sodium salt (1:1) (P-17-33)..         6654-64-4
Benzoic acid, 4-fluoro-, sodium salt (1:1) (P-17-34)..          499-90-1
Benzoic acid, 2,3,4,5-tetrafluoro-, sodium salt (1:1)         67852-79-3
 (P-17-36)............................................
Benzoic acid, 2-(trifluoromethyl)-, sodium salt (1:1)          2966-44-1
 (P-17-38)............................................
Benzoic acid, 4-(trifluoromethyl)-, sodium salt (1:1)         25832-58-0
 (P-17-39)............................................
Benzoic acid, 2,5-difluoro-, sodium salt (1:1) (P-17-        522651-42-9
 41)..................................................
Benzoic acid, 3-fluoro-, sodium salt (1:1) (P-17-42)..          499-57-0
Benzoic acid, 2,6-difluoro-, sodium salt (1:1) (P-17-          6185-28-0
 43)..................................................
Benzoic acid, 3,5-difluoro-, sodium salt (1:1) (P-17-        530141-39-0
 45)..................................................
Benzoic acid, 2,4-difluoro-, sodium salt (1:1) (P-17-          1765-08-8
 47)..................................................
Benzoic acid, 3,4-difluoro-, sodium salt (1:1) (P-17-        522651-44-1
 50)..................................................
Benzoic acid, 3,4,5-trifluoro-, sodium salt (1:1) (P-       1180493-12-2
 17-52)...............................................
Benzoic acid, 2,3,4-trifluoro-, sodium salt (1:1) (P-        402955-41-3
 17-55)...............................................
Benzoic acid, 2,4,5-trifluoro-, sodium salt (1:1) (P-        522651-48-5
 17-57)...............................................
Benzoic acid, 2,3-difluoro-, sodium salt (1:1) (P-17-       1604819-08-0
 59)..................................................
Benzoic acid, 3-(trifluoromethyl)-, sodium salt (1:1)         69226-41-1
 (P-17-61)............................................
Benzoic acid, 2-chloro-, sodium salt (1:1) (P-17-62)..        17264-74-3
Benzoic acid, 4-chloro-, sodium salt (1:1) (P-17-63)..         3686-66-6
Benzoic acid, 3-chloro-, sodium salt (1:1) (P-17-64)..        17264-88-9
Benzoic acid, 2,3-dichloro-, sodium salt (1:1) (P-17-        118537-84-1
 66)..................................................
Benzoic acid, 2,5-dichloro-, sodium salt (1:1) (P-17-         63891-98-5
 67)..................................................
Benzoic acid, 3,5-dichloro-, sodium salt (1:1) (P-17-        154862-40-5
 69)..................................................
Benzoic acid, 2,6-dichloro-, sodium salt (1:1) (P-17-         10007-84-8
 71)..................................................
Benzoic acid, 3,4-dichloro-, sodium salt (1:1) (P-17-         17274-10-1
 72)..................................................
Benzoic acid, 2,4-dichloro-, sodium salt (1:1) (P-17-         38402-11-8
 73)..................................................
Benzoic acid, 2-chloro-4-fluoro-, sodium salt (P-17-         855471-43-1
 75)..................................................
Benzoic acid, 3-chloro-4-fluoro-, sodium salt (P-17-        1421761-18-3
 76)..................................................
Benzoic acid, 5-chloro-2-fluoro-, sodium salt (P-17-        1382106-78-6
 79)..................................................
Benzoic acid, 4-chloro-3-fluoro-, sodium salt (P-17-        1421029-88-0
 80)..................................................
Benzoic acid, 4-chloro-2-fluoro-, sodium salt (P-17-        1382106-64-0
 83)..................................................
Benzoic acid, 5-bromo-2-chloro-, sodium salt (P-17-85)      1938142-12-1
Benzoic acid, 3-bromo-4-fluoro-, sodium salt (P-17-87)       938142-13-2
Benzoic acid, 2-bromo-5-fluoro-, sodium salt (P-17-90)      1938142-14-3
Benzoic acid, 4-bromo-2-fluoro-, sodium salt (P-17-91)      1938142-15-4
Benzoic acid, 4-bromo-3-fluoro-, sodium salt (P-17-93)      1535169-81-3
------------------------------------------------------------------------

    Effective date of TSCA section 5(e) Order: March 22, 2017.
    Basis for TSCA section 5(e) Order: The PMNs state that the generic 
(non-confidential) use of the substances are for monitoring of oil/gas 
well performance. Based on test data on an analog, EPA has identified 
concerns for reproductive, developmental and neuro-toxicity, as well as 
lung toxicity and dermal irritation. The Order was issued under TSCA 
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on insufficient 
information to make a reasoned evaluation and a finding that the 
substances may present an unreasonable risk of injury to human health. 
EPA assessed risks based on the specific manufacturing, processing, 
use, process equipment, engineering controls, and handling practices 
(including worker activities and cleaning procedures) described in the 
PMN. To protect against these risks, the Order requires:
    1. Submission of certain toxicity testing on the PMN substances 
prior to exceeding the production volume limit as specified in the 
Order.
    2. Use of personal protective equipment including impervious gloves 
(where there is a potential for dermal exposure).
    3. Use of a NIOSH-certified respirator with an APF of at least 50 
(where there is a potential for inhalation exposure) or compliance with 
a NCEL of 0.0184 ppm as an 8-hour time-weighted average.
    4. Use of processes, process equipment, engineering controls, and 
handling practices specified in the Order for manufacturing and 
processing.
    5. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    6. No manufacture or process of the PMN substances beyond a 
confidential annual production volume specified in the Order.
    The SNUR will designate as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the human health toxicity of the PMN substances may 
be potentially useful to characterize the effects of the PMN substances 
in support of a request by the PMN submitter to modify the Order, or if 
a manufacturer or processor is considering submitting a SNUN for a 
significant new use that will be designated by this SNUR. The submitter 
has agreed not to exceed the confidential production limit without 
performing specific target organ toxicity testing on P-17-0091.
    CFR citations: 40 CFR 721.11053.

PMN Numbers: P-17-35, P-17-37, P-17-40, P-17-44, P-17-46, P-17-48, P-
17-51, P-17-53, P-17-54, P-17-56, P-17-58, P-17-60, P-17-65, P-17-68, 
P-17-70, P-17-74, P-17-77, P-17-78, P-17-81, P-17-82, P-17-84, P-17-88, 
P-17-89, P-17-92, P-17-97

[[Page 37714]]



                     Chemical Names and CAS Numbers
------------------------------------------------------------------------
                     Chemical Name                           CAS No.
------------------------------------------------------------------------
Benzoic acid, 2,3,4,5-tetrafluoro- (P-17-35)..........         1201-31-6
Benzoic acid, 2-(trifluoromethyl)- (P-17-37)..........          433-97-6
Benzoic acid, 2,5-difluoro- (P-17-40).................         2991-28-8
Benzoic acid, 2,6-difluoro- (P-17-44).................          385-00-2
Benzoic acid, 3,5-difluoro- (P-17-46).................          455-40-3
Benzoic acid, 2,4-difluoro- (P-17-48).................         1583-58-0
Benzoic acid, 3,4-difluoro- (P-17-51).................          455-86-7
Benzoic acid, 3,4,5-trifluoro- (P-17-53)..............       121602-93-5
Benzoic acid, 2,3,4-trifluoro- (P-17-54)..............        61079-72-9
Benzoic acid, 2,4,5-trifluoro- (P-17-56)..............          446-17-3
Benzoic acid, 2,3-difluoro- (P-17-58).................         4519-39-5
Benzoic acid, 3-(trifluoromethyl)- (P-17-60)..........          454-92-2
Benzoic acid, 2,3-dichloro- (P-17-65).................           50-45-3
Benzoic acid, 3,5-dichloro- (P-17-68).................           51-36-5
Benzoic acid, 2,6-dichloro- (P-17-70).................           50-30-6
Benzoic acid, 2-chloro-4-fluoro- (P-17-74)............         2252-51-9
Benzoic acid, 5-chloro-2-fluoro- (P-17-77)............          394-30-9
Benzoic acid, 3-chloro-4-fluoro- (P-17-78)............          403-16-7
Benzoic acid, 4-chloro-3-fluoro- (P-17-81)............          403-17-8
Benzoic acid, 4-chloro-2-fluoro- (P-17-82)............          446-30-0
Benzoic acid, 5-bromo-2-chloro- (P-17-84).............        21739-92-4
Benzoic acid, 3-bromo-4-fluoro- (P-17-88).............        11007-16-5
Benzoic acid, 2-bromo-5-fluoro- (P-17-89).............          394-28-5
Benzoic acid, 4-bromo-3-fluoro- (P-17-92).............       153556-42-4
Benzoic acid, 4-bromo-2-fluoro- (P-17-97).............       112704-79-7
------------------------------------------------------------------------

    Effective date of TSCA section 5(e) Order: March 22, 2017.
    Basis for TSCA section 5(e) Order: The PMNs state that the generic 
(non-confidential) use of the substances are for monitoring of oil/gas 
well performance. Based on test data on an analog, EPA has identified 
concerns for reproductive, developmental and neuro-toxicity, as well as 
lung toxicity and dermal irritation. The Order was issued under TSCA 
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on insufficient 
information to make a reasoned evaluation and a finding that the 
substances may present an unreasonable risk of injury to human health. 
EPA assessed risks based on the specific manufacturing, processing, 
use, process equipment, engineering controls, and handling practices 
(including worker activities and cleaning procedures) described in the 
PMN. To protect against these risks, the Order requires:
    1. Submission of certain toxicity testing on the PMN substances 
prior to exceeding the production volume limit as specified in the 
Order.
    2. Use of personal protective equipment including impervious gloves 
(where there is a potential for dermal exposure).
    3. Use of a NIOSH-certified respirator with an APF of at least 50 
(where there is a potential for inhalation exposure) or compliance with 
a NCEL of 0.0184 ppm as an 8-hour time-weighted average to prevent 
inhalation exposure.
    4. Use of processes, process equipment, engineering controls, and 
handling practices specified in the Order for manufacturing and 
processing.
    5. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    6. No manufacture or process of the PMN substances beyond a 
confidential annual production volume specified in the Order.
    The SNUR will designate as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the human health toxicity of the PMN substances may 
be potentially useful to characterize the effects of the PMN substances 
in support of a request by the PMN submitter to modify the Order, or if 
a manufacturer or processor is considering submitting a SNUN for a 
significant new use that will be designated by this SNUR. The submitter 
has agreed not to exceed the confidential production limit without 
performing specific target organ toxicity and reproductive/
developmental toxicity testing on both P-17-35 and P-17-37.
    CFR citations: 40 CFR 721.11054.

PMN Numbers: P-17-94, P-17-95, P-17-96, P-17-98, P-17-99, P-17-100, P-
17-101, P-17-102, P-17-103, P-17-104, P-17-105, P-17-114, P-17-122, P-
17-123, P-17-124, P-17-125, P-17-126, P-17-127, P-17-128, P-17-129, P-
17-130, P-17-131, P-17-132, P-17-133, P-17-134, P-17-135, P-17-136, P-
17-137, P-17-138, P-17-139, and P-17-140

                     Chemical Names and CAS Numbers
------------------------------------------------------------------------
                     Chemical name                           CAS No.
------------------------------------------------------------------------
Benzoic acid, 2,3,4,5-tetrafluoro-, ethyl ester (P-17-       122894-73-9
 94)..................................................
Benzoic acid, 4-(trifluoromethyl)-, ethyl ester (P-17-          583-02-8
 95)..................................................
Benzoic acid, 2-(trifluoromethyl)-, ethyl ester (P-17-          577-62-8
 96)..................................................
Benzoic acid, 2,6-difluoro-, ethyl ester (P-17-98)....        19064-14-3
Benzoic acid, 2,5-difluoro-, ethyl ester (P-17-99)....          708-25-8
Benzoic acid, 2,3,4-trifluoro-, ethyl ester (P-17-100)       351354-50-2
Benzoic acid, 2-bromo-5-fluoro-, ethyl ester (P-17-          351354-50-2
 101).................................................
Benzoic acid, 3,5-difluoro-, ethyl ester (P-17-102)...          350-19-6

[[Page 37715]]

 
Benzoic acid, 5-bromo-2-chloro-, ethyl ester (P-17-           76008-73-6
 103).................................................
Benzoic acid, 3-chloro-, ethyl ester (P-17-104........         1128-76-3
Benzoic acid, 2-chloro-, ethyl ester (P-17-105).......         7335-25-3
Benzoic acid, 3-chloro-4-fluoro-, ethyl ester (P-17-         137521-81-4
 114).................................................
Benzoic acid, 4-bromo-2-fluoro-, ethyl ester (P-17-          474709-71-2
 122).................................................
Benzoic acid, 2-bromo-4,5-difluoro-, ethyl ester (P-17-      144267-97-0
 123).................................................
Benzoic acid, 4-bromo-3-fluoro-, ethyl ester (P-17-         1130165-74-0
 124).................................................
Benzoic acid, 3-bromo-4-fluoro-, ethyl ester (P-17-           23233-33-2
 125).................................................
Benzoic acid, 4-chloro-2-fluoro-, ethyl ester (P-17-           4793-20-8
 126).................................................
Benzoic acid, 2,5-dichloro-, ethyl ester (P-17-127)...        35112-27-7
Benzoic acid, 4-chloro-3-fluoro-, ethyl ester (P-17-         203573-08-4
 128).................................................
Benzoic acid, 2-chloro-4-fluoro-, ethyl ester (P-17-         167758-87-4
 129).................................................
Benzoic acid, 5-chloro-2-fluoro-, ethyl ester (P-17-         773139-56-3
 130).................................................
Benzoic acid, 2,4-difluoro-, ethyl ester (P-17-131)...       108928-00-3
Benzoic acid, 3,4-difluoro-, ethyl ester (P-17-132)...       144267-96-9
Benzoic acid, 3,4,5-trifluoro-, ethyl ester (P-17-133)       495405-09-9
Benzoic acid, 2,4,5-trifluoro-, ethyl ester (P-17-134)       351354-41-1
Benzoic acid, 3-(trifluoromethyl)-, ethyl ester (P-17-        76783-59-0
 135).................................................
Benzoic acid, 2,3-difluoro-, ethyl ester (P-17-136)...       773134-65-9
Benzoic acid, 2,6-dichloro-, ethyl ester (P-17-137)...        81055-73-4
Benzoic acid, 3,5-dichloro-, ethyl ester (P-17-138)...        91085-56-2
Benzoic acid, 2,4-dichloro-, ethyl ester (P-17-139)...        56882-52-1
Benzoic acid, 3,4-dichloro-, ethyl ester (P-17-140)...        28394-58-3
------------------------------------------------------------------------

    Effective date of TSCA section 5(e) Order: March 22, 2017.
    Basis for TSCA section 5(e) Order: The PMNs state that the 
substances are for monitoring oil/gas well performance. Based on test 
data on an analog, EPA has identified concerns for reproductive, 
developmental and neuro-toxicity, as well as lung toxicity and dermal 
irritation. Further, based on SAR analysis of test data on analogous 
neutral organics, EPA predicts toxicity to aquatic organisms may occur 
at concentrations that exceed 15 ppb of the PMN substances 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 insufficient information to make a reasoned 
evaluation and a finding that the substances may present an 
unreasonable risk of injury to human health and the environment. EPA 
assessed risks based on the specific manufacturing, processing, use, 
process equipment, engineering controls, and handling practices 
(including worker activities and cleaning procedures) described in the 
PMNs. To protect against these risks, the Order requires:
    1. Submission of certain toxicity testing on the PMN substances 
prior to exceeding the production volume limit as specified in the 
Order.
    2. Use of personal protective equipment including impervious gloves 
(where there is a potential for dermal exposure).
    3. Use of a NIOSH-certified respirator with an APF of at least 
1,000 (where there is a potential for inhalation exposure) or 
compliance with a NCEL of 0.0184 ppm as an 8-hour time-weighted 
average.
    4. Use of processes, process equipment, engineering controls, and 
handling practices specified in the Order for manufacturing and 
processing.
    5. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    6. No manufacture or process of the PMN substances beyond a 
confidential annual production volume specified in the Order.
    7. No release of the PMN substances resulting in surface water 
concentrations that exceed 15 ppb.
    The SNUR will designate as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the human health and aquatic toxicity of the PMN 
substances may be potentially useful to characterize the effects of the 
PMN substances in support of a request by the PMN submitter to modify 
the Order, or if a manufacturer or processor is considering submitting 
a SNUN for a significant new use that will be designated by this SNUR. 
The submitter has agreed not to exceed the confidential production 
limit without performing specific target organ toxicity and 
reproductive/developmental toxicity testing on P-17-127; specific 
target organ toxicity testing on P-17-101; and acute aquatic toxicity 
testing on both P-17-101 and P-17-127.
    CFR citations: 40 CFR 721.11055.

PMN Number: P-17-198

    Chemical name: Neodymium aluminium alkyl polymer complexes 
(generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: April 27, 2017.
    Basis for TSCA section 5(e) Order: The PMN states the generic (non-
confidential) use of the substance will be as a catalyst in a closed 
process. Based on physical/chemical properties of the substance and 
test data on the PMN substance, EPA has identified concerns for dermal 
and respiratory irritation, corrosion, developmental toxicity, and lung 
effects. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 
5(e)(1)(A)(ii)(I), based on insufficient information to make a reasoned 
evaluation and a finding that the substance may present an unreasonable 
risk of injury to human health. To protect against these risks, the 
Order requires:
    1. Submission of glove permeation testing on the PMN substance 
prior to exceeding the production volume limit as specified in the 
Order.
    2. Use of personal protective equipment including impervious gloves 
(where there is a potential for dermal exposure).
    3. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    4. No domestic manufacture of the PMN substance.
    5. No use in any manner or method where there is potential for 
inhalation exposure.

[[Page 37716]]

    6. Use of the PMN substance in a closed system as specified in the 
PMN.
    The SNUR will designate as a ``significant new use'' the absence of 
these protective measure.
    Potentially useful information: EPA has determined that the results 
of glove permeability testing will help characterize the effectiveness 
of protective measures to mitigate human health risk 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 manufacture beyond a certain time 
period without performing glove permeability testing.
    CFR citation: 40 CFR 721.11056.

PMN Numbers: P-17-272, P-17-273, P-17-274, P-17-275, P-17-276 and P-17-
277

    Chemical name: Fatty acid amide alkyl amine salts (generic).
    CAS numbers: Not available.
    Effective date of TSCA section 5(e) Order: August 4, 2017.
    Basis for TSCA section 5(e) Order: The PMNs state that the generic 
(non-confidential) use of the substances will be as a component in 
asphalt emulsion. Based on SAR analysis of test data on analogous 
substances, EPA has identified concerns for dermal and respiratory 
irritation, corrosion, developmental toxicity, systemic effect, 
sensitization and lung effects. The Order was issued under TSCA 
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on insufficient 
information to make a reasoned evaluation and a finding that the 
substances may present an unreasonable risk of injury to human health 
and environment. To protect against these risks, the Order requires:
    1. Use of the PMN substances only for the use specified in the 
Order.
    2. Use of personal protective equipment for workers exposed 
dermally to the PMN substances (including impervious gloves, chemical 
goggles or equivalent eye protection and clothing which covers any 
other exposed areas of the arms and torso).
    3. No modification of the manufacture, process or use of the PMN 
substances if it results in inhalation exposure to vapor, dust, mist or 
aerosol.
    4. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    5. No release of the PMN substances into the waters of the United 
States.
    The SNUR will designate as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the human health and aquatic toxicity of the PMN 
substances may be potentially useful to characterize the effects of the 
PMN substances in support of a request by the PMN submitter to modify 
the Order, or if a manufacturer or processor is considering submitting 
a SNUN for a significant new use that will be designated by this SNUR. 
EPA has determined that the results of specific target organ toxicity 
testing of the PMN substances, and acute and chronic aquatic toxicity 
testing of the PMN substances may be potentially useful in 
characterizing the health and environmental effects of the PMN 
substances. Although the Order does not require these tests, the 
Order's restrictions on manufacture, processing and distribution in 
commerce, 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 721.11057.

PMN Numbers: P-17-278, P-17-279 and P-17-280

    Chemical name: Fatty acid amide alkyl amine salts (generic).
    CAS numbers: Not available.
    Effective date of TSCA section 5(e) Order: August 4, 2017.
    Basis for TSCA section 5(e) Order: The PMNs state that the generic 
(non-confidential) use of the substances will be as a component in 
asphalt emulsion. Based on SAR analysis of test data on analogous 
substances, EPA has identified concerns for irritation, corrosion, 
developmental toxicity, systemic effect, sensitization and lung 
effects. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 
5(e)(1)(A)(ii)(I), based on insufficient information to make a reasoned 
evaluation and a finding that the substances may present an 
unreasonable risk of injury to human health and environment. To protect 
against these risks, the Order requires:
    1. Use of the PMN substances only for the use specified in the 
Order.
    2. Use of personal protective equipment for workers exposed 
dermally to the PMN substances (including impervious gloves, chemical 
goggles or equivalent eye protection and clothing which covers any 
other exposed areas of the arms and torso).
    3. No modification of the manufacture, process or use of the PMN 
substances if it results in inhalation exposure to vapor, dust, mist or 
aerosol.
    4. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    5. No release of the PMN substances into the waters of the United 
States.
    The SNUR will designate as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the human health and aquatic toxicity of the PMN 
substances may be potentially useful to characterize the effects of the 
PMN substances in support of a request by the PMN submitter to modify 
the Order, or if a manufacturer or processor is considering submitting 
a SNUN for a significant new use that will be designated by this SNUR. 
EPA has determined that the results of specific target organ toxicity 
testing and acute and chronic aquatic toxicity testing of the PMN 
substances may be potentially useful in characterizing the health and 
environmental effects of the PMN substances. Although the Order does 
not require these tests, the Order's restrictions on manufacture, 
processing and distribution in commerce 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 721.11058.

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 145 
chemical substances regulation was warranted under TSCA section 5(e), 
pending the development of information sufficient to make reasoned 
evaluations of the health or environmental effects of the chemical 
substances. The basis for such findings is outlined in Unit IV. Based 
on these findings, TSCA section 5(e) consent 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).

[[Page 37717]]

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 1, 2018 without further notice, unless EPA 
receives written adverse comments before August 31, 2018.
    If EPA receives written adverse comments on one or more of these 
SNURs before August 31, 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) consent orders have 
been issued for all of the chemical substances, and the PMN submitters 
are prohibited by the TSCA section 5(e) consent orders from undertaking 
activities which will be designated as significant new uses. The 
identities of 38 of the 145 chemical substances subject to this rule 
have been claimed as confidential and EPA has received one 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 1, 2018 (the date of public 
release of this rule) 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) consent orders for the chemical 
substances regulated under this rule, EPA has established production 
volume limits in view of the lack of data on the potential health and 
environmental risks that may be posed by the significant new uses or 
increased exposure to the chemical substances. These limits cannot be 
exceeded unless the PMN submitter first submits the results of 
specified tests that would permit a reasoned evaluation of the

[[Page 37718]]

potential risks posed by these chemical substances. Under recent TSCA 
section 5(e) consent orders, each PMN submitter is required to submit 
each study at least 14 weeks (earlier TSCA section 5(e) consent 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) consent 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 Consent 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-2017-0366.

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) consent orders. The 
Office of Management and Budget (OMB) has exempted these types of 
actions from review under Executive Order 12866, entitled ``Regulatory 
Planning and Review'' (58 FR 51735, October 4, 1993).

B. Paperwork Reduction Act (PRA)

    According to PRA (44 U.S.C. 3501 et seq.), an agency may not 
conduct or sponsor, and a person is not required to respond to a 
collection of information that requires OMB approval under PRA, unless 
it has been approved by OMB and displays a currently valid OMB control 
number. The OMB control numbers for EPA's regulations in title 40 of 
the CFR, after appearing in the Federal Register, are listed in 40 CFR 
part 9, and included on the related collection instrument or form, if 
applicable. EPA is amending the table in 40 CFR part 9 to list the OMB 
approval number for the information collection requirements contained 
in this action. This listing of the OMB control numbers and their 
subsequent codification in the CFR satisfies the display requirements 
of PRA and OMB's implementing regulations at 5 CFR part 1320. This 
Information Collection Request (ICR) was previously subject to public 
notice and comment prior to OMB approval, and given the technical 
nature of the table, EPA finds that further notice and comment to amend 
it is unnecessary. As a result, EPA finds that there is ``good cause'' 
under section 553(b)(3)(B) of the Administrative Procedure Act (5 
U.S.C. 553(b)(3)(B)) to amend this table without further notice and 
comment.
    The information collection requirements related to this action have 
already been approved by OMB pursuant to PRA under OMB control number 
2070-0012 (EPA ICR No. 574). This action does not impose any burden 
requiring additional OMB approval. If an entity were to submit a SNUN 
to the Agency, the annual burden is estimated to average between 30 and 
170 hours per response. This burden estimate

[[Page 37719]]

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: July 19, 2018.
Jeffery T. Morris,
Director, Office of Pollution Prevention and Toxics.

    Therefore, 40 CFR parts 9 and 721 are amended as follows:

PART 9--[AMENDED]

0
 1. The authority citation for part 9 continues to read as follows:

    Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003, 
2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330, 
1342, 1344, 1345(d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 
1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g, 
300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2, 
300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542, 
9601-9657, 11023, 11048.

0
 2. In Sec.  [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:


Sec.  9.1  OMB approvals under the Paperwork Reduction Act.

* * * * *

------------------------------------------------------------------------
                                                           OMB  control
                     40 CFR citation                            No.
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
               Significant New Uses of Chemical Substances
------------------------------------------------------------------------
 
                                * * * * *
721.11024...............................................       2070-0012

[[Page 37720]]

 
721.11025...............................................       2070-0012
721.11026...............................................       2070-0012
721.11027...............................................       2070-0012
721.11028...............................................       2070-0012
721.11029...............................................       2070-0012
721.11030...............................................       2070-0012
721.11031...............................................       2070-0012
721.11032...............................................       2070-0012
721.11033...............................................       2070-0012
721.11034...............................................       2070-0012
721.11035...............................................       2070-0012
721.11036...............................................       2070-0012
721.11037...............................................       2070-0012
721.11038...............................................       2070-0012
721.11039...............................................       2070-0012
721.11040...............................................       2070-0012
721.11041...............................................       2070-0012
721.11042...............................................       2070-0012
721.11043...............................................       2070-0012
721.11044...............................................       2070-0012
721.11045...............................................       2070-0012
721.11046...............................................       2070-0012
721.11047...............................................       2070-0012
721.11048...............................................       2070-0012
721.11049...............................................       2070-0012
721.11050...............................................       2070-0012
721.11051...............................................       2070-0012
721.11052...............................................       2070-0012
721.11053...............................................       2070-0012
721.11054...............................................       2070-0012
721.11055...............................................       2070-0012
721.11056...............................................       2070-0012
721.11057...............................................       2070-0012
721.11058...............................................       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]721.11024 to subpart E to read as follows:


Sec.  721.11024  Polyphosphoric acids, 2-[alkyl-1-oxo-2-propen-1-
yl)oxy]ethyl esters, compds. with N-(aminoiminomethyl)urea (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
polyphosphoric acids, 2-[alkyl-1-oxo-2-propen-1-yl)oxy]ethyl esters, 
compds. with N-(aminoiminomethyl)urea (PMN P-14-472) 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), (3), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1)(i), (ii), (sensitization), (g)(2)(i), 
(v), (g)(3)(i), (ii), (g)(4)(i), 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(h), (q), and (y)(1). It is a significant 
new use to have manufacturing activities that result in inhalation 
exposure.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N = 3.
    (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
5. Add Sec.  [emsp14]721.11025 to subpart E to read as follows:


Sec.  721.11025  Polyphosphoric acids, 2-[(2-methyl-1-oxo-2-propen-1-
yl)oxy]ethyl esters, compds. with alkyl amino, polymers with Bu 
acrylate, N-(hydroxymethyl)propenamide and styrene (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
polyphosphoric acids, 2-[(2-methyl-1-oxo-2-propen-1-yl)oxy]ethyl 
esters, compds. with alkyl amino, polymers with Bu acrylate, N-
(hydroxymethyl)propenamide and styrene (PMN P-14-496) 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), (3), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a), through (f), (g)(1)(i), (ii), (sensitization), (g)(2)(i), 
(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(k), (q) and (y)(1). It is a significant 
new use to have manufacturing activities that result in inhalation 
exposure.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N = 4.
    (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
6. Add Sec.  [emsp14]721.11026 to subpart E to read as follows:


Sec.  721.11026  Bismuth bromide iodide oxide.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as bismuth bromide 
iodide oxide (PMN P-14-630, CAS No. 340181-06-8) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section. The requirements of this section do 
not apply to quantities of the substance after they have been reacted 
(cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(4), when determining which persons are reasonably likely to 
be exposed as required for Sec.  721.63(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 10), (a)(6)(i) (particulate), (b) 
(concentration set at 1.0%), 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 2.4 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

[[Page 37721]]

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 at 1.0%), (f), (g)(1)(ii), 
(g)(2)(ii), (use respiratory protection or maintain workplace airborne 
concentrations at or below an 8-hour time-weighted average of 2.4 mg/
m\3\), 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). It is a significant new use to vary or 
alter, the manufacturing, processing, and use, distribution/
transportation, treatment and disposal processes, process equipment, 
engineering controls, and handling practices (including worker 
activities and cleaning procedures) described in the PMN in such a way 
as to change the magnitude of inhalation exposure. It is a significant 
new use to use the substance for a consumer product that generates a 
dust, mist, or aerosol.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (d), and (f) 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
7. Add Sec.  [emsp14]721.11027 to subpart E to read as follows:


Sec.  721.11027  Aluminum cobalt lithium nickel oxide.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as aluminum cobalt 
lithium nickel oxide (PMN P-15-450, CAS No. 177997-13-6) 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), (3), (4), when determining which persons are reasonably 
likely to be exposed as required for Sec.  721.63(a)(1) and (4), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible, (a)(5) 
(respirators must provide a National Institute for Occupational Safety 
and Health (NIOSH) assigned protection factor (APF) of at least 1,000), 
(a)(6) (particulate) (b) (concentration set at 0.1%), and (c). It is a 
significant new use to manufacture or process the substance without the 
chemical transfer processes and air ventilation processes described in 
the PMN and the exposure monitoring requirements described in the 
Order.
    (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 0.000092 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 0.1%), (f), (g)(1)(ii), (This 
substance may cause damage to the lung, kidney, and spleen), 
(g)(1)(vii), (g)(2)(i), (ii), (iii), (When using this substance wear 
protective gloves/protective clothing/eye protection/face protection), 
the following human health precautionary statement must appear on the 
SDS as specified in paragraph (a)(2)(ii): (When using this substance 
use respiratory protection or maintain workplace airborne 
concentrations at or below an 8-hour time-weighted average of 0.000092 
mg/m\3\), (g)(2)(v), 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(p) (24 months and 6 years).
    (iv) Disposal. Requirements as specified in Sec.  721.85(a)(2), 
(b)(2), and (c)(2). It is a significant new use to release this 
chemical substance to air unless using the chemical transfer and air 
ventilation processes described in P-15-0450 including filtering 
through a high-efficiency particular air filter with an efficiency rate 
of 99.99% before release to air.
    (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 (j) 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]721.11028 to subpart E to read as follows:


Sec.  721.11028  Alkylarylamine (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alkylarylamine (PMN P-15-705) 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), (ii), (iii), (a)(3), and (4), when determining 
which persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible, (a)(5) (respirators must provide a National Institute 
for Occupational Safety and Health (NIOSH) assigned protection factor 
(APF) of at least 1,000), (a)(6)(particulate), (a)(6)(v), (vi), (b) 
(concentration set at 0.1%), 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 0.48 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

[[Page 37722]]

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 at 0.1%), (f), (g)(1)(i), 
(ii), (iv), (vi), (vii), (ix), (g)(2)(i), (ii), (iii), (use respiratory 
protection or maintain workplace airborne concentrations at or below an 
8-hour time-weighted average of 0.48 mg/m\3\), (g)(2)(v), (g)(3)(ii), 
(g)(4)(i), 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(o) and (q). It is a significant new use to 
use the substance other than as a chemical intermediate or as an 
additive and octane booster in aviation fuels.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N = 1.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (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
9. Add Sec.  [emsp14]721.11029 to subpart E to read as follows:


Sec.  721.11029  Aliphatic N-alkyl urea polymer containing cyclohexyl 
groups and trimethoxy silanes (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
aliphatic N-alkyl urea polymer containing cyclohexyl groups and 
trimethoxy silanes (PMN P-15-706) 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),(iii), (iv), (a)(3) and (4), when determining 
which persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible, (a)(5) (respirators must provide a National Institute 
for Occupational Safety and Health (NIOSH) assigned protection factor 
(APF) of at least 10), (a)(6) (particulate), (a)(6)(v), (vi), (b) 
(concentration set at 1.0%), 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 at 1.0%), (f), (g)(1)(ii), 
(ix), (g)(2)(i), (ii), (iii), (use respiratory protection or maintain 
workplace airborne concentrations at or below an 8-hour time-weighted 
average of 0.9 mg/m\3\), (g)(2)(v), 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), (o), (p) (594,000 kilograms, P-15-706 
and P-15-707 combined), and (t)(250,000 kilograms, P-15-706 and P-15-
707 combined). A significant new use is any manufacture, processing, or 
use of the PMN substance with more than 0.1% residual isocyanate by 
weight.
    (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]721.11030 to subpart E to read as follows:


Sec.  721.11030  Aliphatic N-alkyl urea polymer containing aspartic 
ester groups and trimethoxy silanes (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
aliphatic N-alkyl urea polymer containing aspartic ester groups and 
trimethoxy silanes (PMN P-15-707) 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), (iii), (iv), (a)(3), (4), when determining 
which persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible, (a)(5) (respirators must provide a National Institute 
for Occupational Safety and Health (NIOSH) assigned protection factor 
(APF) of at least 10), (a)(6)(i), (v), (vi), (b) (concentration set at 
1.0%), 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 at 1.0%), (f), (g)(1)(ii), 
(g)(1)(ix), (g)(2)(i), (ii), (iii), (use respiratory protection or 
maintain workplace airborne concentrations at or below an 8-hour time-
weighted average of 0.9 mg/m\3\), (g)(2)(v), and (g)(5).

[[Page 37723]]

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), (o), (p) (594,000 kilograms, P-15-706 
and P-15-707 combined), and (t) (250,000 kilograms, P-15-706 and P-15-
707 combined). A significant new use is any manufacture, processing, or 
use of the PMN substance with more than 1% residual isocyanate by 
weight.
    (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
11. Add Sec.  [emsp14]721.11031 to subpart E to read as follows:


Sec.  721.11031  Alkyl heteromonocycle, polymer with heteromonocycle, 
carboxyalkyl alkyl ether (generic).

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substances identified generically as alkyl 
heteromonocycle, polymer with heteromonocycle, carboxyalkyl alkyl ether 
(PMNs P-16-273 and P-16-0274) are subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (iii), (a)(3), (b) (concentration set at 
1.0%), and (c). 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.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i), 
(ii), (dermal sensitization), (g)(2)(i), (ii), (iii), and (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). It is a significant new use to use the 
substances for the uses specified in the Order, at a concentration 
greater than 3% of the metal working fluid, and use other than the 
closed metal working systems as specified in the PMNs with no 
modifications in the process that would result in worker inhalation 
exposure.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N = 10.
    (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
 12. Add Sec.  721.11032 to subpart E to read as follows:


Sec.  721.11032  Benzene dicarboxylic acid, polymer with alkane dioic 
acid and aliphatic diamine (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as generically as 
benzene dicarboxylic acid, polymer with alkane dioic acid and aliphatic 
diamine (PMN P-16-289) 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)(Manufacture only in a form with a 
particle size distribution where less than 1.0 percent of the particles 
are less than 10 microns) and (p) (six months).
    (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 (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
 13. Add Sec.  721.11033 to subpart E to read as follows:


Sec.  721.11033  Manganese cyclic (tri)amine chloride complex 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
manganese cyclic (tri)amine chloride complex (PMN P-16-322) 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), (3), (4), when determining which persons are reasonably 
likely to be exposed as required for Sec.  721.63(a)(1) and (4), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible, (a)(5) 
(respirators must provide a National Institute for Occupational Safety 
and Health (NIOSH) assigned protection factor (APF) of at least 25), 
(a)(6)(i), (particulate), (b) (concentration set at 1.0%), 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 1.2 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 at 1.0%), (f), (g)(1)(iv), 
(vi), (viii), (ix), (g)(2)(i), (ii), (iii), (use respiratory protection 
or maintain workplace airborne concentrations at or below an 8-hour 
time-weighted average of 1.2 mg/m\3\), (v), (g)(3) (This substance may 
be toxic to algae. This substance may be harmful to invertebrates), 
(g)(4)(i), (ii), (do not release to water to yield surface water

[[Page 37724]]

concentrations above 18 ppb.), 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).
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N = 18.
    (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
14. Add Sec.  721.11034 to subpart E to read as follows:


Sec.  721.11034  Xanthylium, (sulfoaryl)-bis [(substituted aryl) 
amino]-, sulfo derivs., inner salts, metal salts (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
xanthylium, (sulfoaryl)-bis [(substituted aryl) amino]-, sulfo derivs., 
inner salts, metal salts (PMN P-16-338) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (k), and (t).
    (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)(i) of 
this section.

0
 15. Add Sec.  721.11035 to subpart E to read as follows:


Sec.  721.11035  Substituted triazinyl metal salt, diazotized, coupled 
with substituted pyridobenzimidazolesulfonic acids, substituted 
pyridobenzimidazolesulfonic acids, diazotized substituted 
alkanesulfonic acid, diazotized substituted aromatic sulfonate, 
diazotized substituted aromatic sulfonate, metal salts (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
substituted triazinyl metal salt, diazotized, coupled with substituted 
pyridobenzimidazolesulfonic acids, substituted 
pyridobenzimidazolesulfonic acids, diazotized substituted 
alkanesulfonic acid, diazotized substituted aromatic sulfonate, 
diazotized substituted aromatic sulfonate, metal salts (PMN P-16-339) 
is subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (k), and (t).
    (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)(i) of 
this section.

0
16. Add Sec.  [emsp14]721.11036 to subpart E to read as follows:


Sec.  721.11036  Carbon black, (organic acidic carbocyclic)-modified, 
inorganic salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as carbon 
black, (organic acidic carbocyclic)-modified, inorganic salt (PMN P-16-
439) is subject to reporting under this section for the significant new 
uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (k), and (t).
    (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) through (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)(i) of 
this section.

0
 17. Add Sec.  [emsp14]721.11037 to subpart E to read as follows:


Sec.  721.11037   Carbon black, (organic acidic carbocyclic)-modified, 
metal salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as carbon 
black, (organic acidic carbocyclic)-modified, metal salt (PMN P-16-440) 
is subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (k), and (t).
    (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) through (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)(i) of 
this section.

0
 18. Add Sec.  [emsp14]721.11038 to subpart E to read as follows:


Sec.  721.11038  Polyaralkyl aryl ester of methacrylic acid (generic).

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

[[Page 37725]]

generically as polyaralkyl aryl ester of methacrylic acid (PMN P-16-
350) 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, and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1)(i), (ii), (sensitization), 
(mutagenicity); (g)(2)(i), (ii), (iii), (v), 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). It is a significant new use to 
manufacture the substance lower than the minimum average molecular 
weight identified in the Order and to contain more than the maximum 
weight percent of low molecular weight species below 1,000 daltons 
identified in the Order.
    (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
19. Add Sec.  721.11039 to subpart E to read as follows:


Sec.  721.11039  Phenol, 2-[[[3-(octyloxy)propyl]imino]methyl]-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as phenol, 2-[[[3-
(octyloxy)propyl]imino]methyl]- (PMN P-16-352, chemical A; CAS No. 
1858221-49-4) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (a)(3), (a)(6)(v), (vi), (particulate), (b) 
(concentration set at 1.0%), and (c). 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.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72 (a) through (e) (concentration set at 1.0%), (f), (g)(1)(i), 
(iv), (vi), (ix), (g)(2)(i), (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), (p) (10,500 and 13,000 kilograms, 
respectively, for the total of this substance and the substance subject 
to 721.11039), (t) (250 kilograms for the total of this substance and 
the substance subject to 721.11039), and (y)(1).
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N = 1.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (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.

0
 20. Add Sec.  721.11040 to subpart E to read as follows:


Sec.  721.11040  Phenol, 2-[[[3-(decyloxy)propyl]imino]methyl]-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as phenol, 2-[[[3-
(decyloxy)propyl]imino]methyl]- (PMN P-16-352, chemical B; CAS No. 
1858221-50-7) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (a)(3), (a)(6)(v), (vi), (particulate), (b) 
(concentration set at 1.0%), and (c). 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.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i), 
(iv), (vi), (ix), (g)(2)(i), (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), (p) (10,500 and 13,000 kilograms 
respectively for the total of this substance and the substance subject 
to Sec.  721.9998), (t) (250 kilograms for the total of this substance 
and the substance subject to Sec.  721.9998), and (y)(1).
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N = 1.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (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.

0
 21. Add Sec.  721.11041 to subpart E to read as follows:


Sec.  721.11041  Alkyl phenol (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as alkyl 
phenol (PMN P-16-358) is subject to reporting under this section for 
the significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (iii), (iv), (a)(3), when determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) engineering control measures (e.g., enclosure or

[[Page 37726]]

confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible, (b) (concentration set at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(ix), 
(g)(2)(i), (ii), (iii), (v), (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(a) through (c), (g), (q), (y)(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) 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.  721.11042 to subpart E to read as follows:


Sec.  721.11042  Nitrile-butadiene-acrylate terpolymers (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
nitrile-butadiene-acrylate terpolymers PMN P-16-364) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(ii), 
(g)(2)(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.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(h), (k) (Manufacture of the substance with 
a particle size distribution where greater than 5.0 percent of the 
particles are less than 10 microns).
    (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 (c), and (f) 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
 23. Add Sec.  [emsp14]721.11043 to subpart E to read as follows:


Sec.  721.11043  Starch, polymer with 2-propenoic acid, potassium salt, 
oxidized.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as starch, polymer 
with 2-propenoic acid, potassium salt, oxidized (PMN P-16-399, CAS No. 
1638117-09-5) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (6) (particulate), When determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1) 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible, (b) (concentration 
set at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a), (b), (c), (d), (e) (concentration set 1.0%), (f), 
(g)(1)(ii), (g)(2)(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(k) (Manufacture of the substance with a 
particulate size less than 30 microns) and (p) (12 months).
    (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 (d), and (f) 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
 24. Add Sec.  [emsp14]721.11044 to subpart E to read as follows:


Sec.  721.11044  Pentanedioic acid, 2-methyl-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as pentanedioic acid, 
2-methyl- (PMN P-16-430, CAS No. 617-62-9) 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), (4), when determining which persons 
are reasonably likely to be exposed as required for Sec.  721.63(a)(1) 
and (4), engineering control measures (e.g., enclosure or confinement 
of the operation, general and local ventilation) or administrative 
control measures (e.g., workplace policies and procedures) shall be 
considered and implemented to prevent exposure, where feasible, (a)(5) 
(respirators must provide a National Institute for Occupational Safety 
and Health (NIOSH) assigned protection factor (APF) of at least 10), 
(a)(6)(i), (v), (vi), (b) (concentration set at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i), 
(ii), (vi), (g)(2)(i), (ii), (iii), (iv), (v), (g)(3)(i), (ii), 
(g)(4)(i), 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 (k) (import of the substance at or 
below the maximum concentration specified in the Order).
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N = 14.
    (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

[[Page 37727]]

of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

0
 25. Add Sec.  [emsp14]721.11045 to subpart E to read as follows:


Sec.  721.11045  2-Pentanol, 4-methyl-, reaction products with 
phosphorus oxide (P2O5), compounds with alkylamine (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as generically as 2-
pentanol, 4-methyl-, reaction products with phosphorus oxide (P2O5), 
compounds with alkylamine (PMN P-16-495) 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), (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), (b) (concentration set 
at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i), 
(ii), (iv), (g)(2)(i), (ii), (v), (g)(3)(i), (ii), (g)(4)(i), 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). A significant new use is 
any manner or method of manufacturing that results in inhalation 
exposure.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N = 200.
    (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
26. Add Sec.  [emsp14]721.11046 to subpart E to read as follows:


Sec.  721.11046  Hydroxy alkylbiphenyl (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as hydroxy 
alkylbiphenyl (PMN P-16-513) 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), (3), (4), when determining which persons are reasonably 
likely to be exposed as required for Sec.  721.63(a)(1) and (4), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible, (a)(5) 
(respirators must provide a National Institute for Occupational Safety 
and Health (NIOSH) assigned protection factor (APF) of at least 50), 
(a)(6)(i), (v), (vi), (b) (concentration set at 1.0%), and (c).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(g) and (q).
    (iii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N = 17.
    (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)(ii) of 
this section.

0
 27. Add Sec.  [emsp14]721.11047 to subpart E to read as follows:


Sec.  721.11047  Alkyl alkenoic acid, polymer with 
alkenylcarbomonocycle telomer with substituted alkanoic acid hydroxyl 
alkyl substituted alkenyl substituted alkyl ester, polyalkylene glycol 
alkyl ether alkyl alkenoate, dialkylene glycol diheteromonocyclic ether 
and alkylcarbomonocyclic alkenoate, metal salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as alkyl 
alkenoic acid, polymer with alkenylcarbomonocycle telomer with 
substituted alkanoic acid hydroxyl alkyl substituted alkenyl 
substituted alkyl ester, polyalkylene glycol alkyl ether alkyl 
alkenoate, dialkylene glycol diheteromonocyclic ether and 
alkylcarbomonocyclic alkenoate, metal salt (PMN P-16-534) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f) and (k). It is a significant new use to 
manufacture the substance such that the lowest number average molecular 
weight is less than 1,800 daltons and the carboxylic acid content 
exceeds 20 percent).
    (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 (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
28. Add Sec.  [emsp14]721.11048 to subpart E to read as follows:


Sec.  721.11048   Alkyl alkenoic acid, polymer with 
alkenylcarbomonocycle telomer with substituted alkanoic acid hydroxyl 
alkyl substituted alkenyl substituted alkyl ester, alkanediol 
diheteromonocyclic ether, polyalkylene glycol alkyl ether alkyl 
alkenoate and alkylcarbomonocyclic alkenoate, metal salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as alkyl 
alkenoic acid, polymer with alkenylcarbomonocycle telomer with 
substituted alkanoic acid hydroxyl alkyl substituted alkenyl 
substituted alkyl ester, alkanediol diheteromonocyclic ether, 
polyalkylene glycol alkyl ether alkyl alkenoate and 
alkylcarbomonocyclic alkenoate, metal salt (PMN P-16-535) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as

[[Page 37728]]

specified in Sec.  721.80(f) and (k). It is a significant new use to 
manufacture the substance such that the lowest number average molecular 
weight is less than 1,800 daltons and the carboxylic acid content 
exceeds 20 percent).
    (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 (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
29. Add Sec.  [emsp14]721.11049 to subpart E to read as follows:


Sec.  721.11049  Alkyl alkenoic acid, polymer with bis heteromonocyclic 
substituted alkyl carbomonocycle, alkenylcarbomonocycle telomer with 
substituted alkanoic acid hydroxyl alkyl substituted alkenyl 
substituted alkyl ester, polyalkylene glycol alkyl ether alkyl 
alkenoate and alkylcarbomonocyclic alkenoate, metal salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as alkyl 
alkenoic acid, polymer with bis heteromonocyclic substituted alkyl 
carbomonocycle, alkenylcarbomonocycle telomer with substituted alkanoic 
acid hydroxyl alkyl substituted alkenyl substituted alkyl ester, 
polyalkylene glycol alkyl ether alkyl alkenoate and 
alkylcarbomonocyclic alkenoate, metal salt (PMN P-16-536) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f) and (k.) It is a significant new use to 
manufacture the substance such that the lowest number average molecular 
weight is less than 1,800 daltons, and the carboxylic acid content 
exceeds 20 percent).
    (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 (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
30. Add Sec.  [emsp14]721.11050 to subpart E to read as follows:


Sec.  721.11050  Certain functionalized methacrylate-substituted 
polymers.

    (a)(1) The chemical substances listed in the Table of this section 
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 substances after they have 
been reacted (cured).

         Table--Functionalized Methacrylate-Substituted Polymers
------------------------------------------------------------------------
              PMN No.                           Chemical name
------------------------------------------------------------------------
P-16-549..........................  Alkaline functionalized methacrylate-
                                     substituted polymer (generic).
P-16-550..........................  Alkaline functionalized methacrylate-
                                     substituted polymer (generic).
P-16-551..........................  Alkaline functionalized methacrylate-
                                     substituted polymer (generic).
P-16-553..........................  Quatenary alkylamine functionalized
                                     methacrylate-substituted polymer
                                     (generic).
P-16-555..........................  Neutral alcohol functionalized
                                     methacrylate-substituted polymer
                                     (generic).
P-16-556..........................  Neutral alcohol functionalized
                                     methacrylate-substituted polymer
                                     (generic).
P-16-557..........................  Neutral alkyl salt functionalized
                                     methacrylate-substituted polymer
                                     (generic).
P-16-558..........................  Neutral alkyl salt functionalized
                                     methacrylate-substituted polymer
                                     (generic).
P-16-560..........................  Neutral alkyl salt functionalized
                                     methacrylate-substituted polymer
                                     (generic).
P-16-561..........................  Acid functionalized methacrylate-
                                     substituted polymer (generic).
P-16-562..........................  Acid functionalized methacrylate-
                                     substituted polymer (generic).
P-16-563..........................  Acid functionalized methacrylate-
                                     substituted polymer (generic).
P-16-564..........................  Acid functionalized methacrylate-
                                     substituted polymer (generic).
P-16-565..........................  Acid functionalized methacrylate-
                                     substituted polymer (generic).
P-16-567..........................  Alkylamine functionalized
                                     methacrylate-substituted polymer
                                     (generic).
------------------------------------------------------------------------

    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (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, (a)(6) 
(particulate), (b) (concentration set at 1.0%), and (c).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f) and (k) (crosslinked resin used for 
chromatographic separation of biomolecules and biocatalysts). It is a 
significant new use to import the substance in any form other than 
spherical beads with 0.1 percent less than 10 microns
    (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), 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
31. Add Sec.  [emsp14]721.11051 to subpart E to read as follows:

[[Page 37729]]

Sec.  721.11051  Waste plastics, poly(ethylene terephthalate), 
depolymd. with polypropylene glycol ether with glycerol (3:1), polymers 
with alkenoic and alkanoic acids (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as waste 
plastics, poly(ethylene terephthalate), depolymd. with polypropylene 
glycol ether with glycerol (3:1), polymers with alkenoic and alkanoic 
acids (PMN P-16-579) 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), (4),when determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(1) and 
(4), engineering control measures (e.g., enclosure or confinement of 
the operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible, (a)(5) 
(respirators must provide a National Institute for Occupational Safety 
and Health (NIOSH) assigned protection factor (APF) of at least 50), 
(a)(6) (particulate), (b) (concentration set 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1) (This 
substance may cause respiratory and dermal irritation). (This substance 
may cause irritation of the mucous membranes). (This substance may 
cause respiratory and dermal sensitization). (This substance may cause 
mutagenicity), (g)(2)(i), (ii), (iii), (iv), (v), (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) (an ultraviolet curable coating resin). 
It is a significant new use to manufacture the substance with an 
average molecular weight less than 1,100 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.

0
32. Add Sec.  [emsp14]721.11052 to subpart E to read as follows:


Sec.  721.11052  1,3,5-Naphthalenetrisulfonic acid.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1,3,5-
naphthalenetrisulfonic acid (PMN P-17-32, CAS No. 6654-64-4) is subject 
to reporting under this section for the significant new uses described 
in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (iv), (a)(3), (4), when determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible, (a)(5) (respirators must provide a National Institute 
for Occupational Safety and Health (NIOSH) assigned protection factor 
of at least 50, (a)(6)(v), (vi), (particulate), (b) (concentration set 
at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i), 
(ii), (iv), (ix), (g)(2)(i), (ii), (iii), (v), 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 (t).
    (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
33. Add Sec.  [emsp14]721.11053 to subpart E to read as follows:


Sec.  721.11053  Certain halogenated sodium benzoate salts.

    (a)(1) The chemical substances listed in the Table of this section 
is subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.

                                    Table--Halogenated Sodium Benzoate Salts
----------------------------------------------------------------------------------------------------------------
                    PMN No.                              CAS No.                       Chemical name
----------------------------------------------------------------------------------------------------------------
P-17-33........................................                6654-64-4  Benzoic acid, 2-fluoro-, sodium salt
                                                                           (1:1).
P-17-34........................................                 499-90-1  Benzoic acid, 4-fluoro-, sodium salt
                                                                           (1:1).
P-17-36........................................               67852-79-3  Benzoic acid, 2,3,4,5-tetrafluoro-,
                                                                           sodium salt (1:1).
P-17-38........................................                2966-44-1  Benzoic acid, 2-(trifluoromethyl)-,
                                                                           sodium salt (1:1).
P-17-39........................................               25832-58-0  Benzoic acid, 4-(trifluoromethyl)-,
                                                                           sodium salt (1:1).
P-17-41........................................              522651-42-9  Benzoic acid, 2,5-difluoro-, sodium
                                                                           salt (1:1).
P-17-42........................................                 499-57-0  Benzoic acid, 3-fluoro-, sodium salt
                                                                           (1:1).
P-17-43........................................                6185-28-0  Benzoic acid, 2,6-difluoro-, sodium
                                                                           salt (1:1).
P-17-45........................................              530141-39-0  Benzoic acid, 3,5-difluoro-, sodium
                                                                           salt (1:1).
P-17-47........................................                1765-08-8  Benzoic acid, 2,4-difluoro-, sodium
                                                                           salt (1:1).
P-17-50........................................              522651-44-1  Benzoic acid, 3,4-difluoro-, sodium
                                                                           salt (1:1).
P-17-52........................................             1180493-12-2  Benzoic acid, 3,4,5-trifluoro-, sodium
                                                                           salt (1:1).
P-17-55........................................              402955-41-3  Benzoic acid, 2,3,4-trifluoro-, sodium
                                                                           salt (1:1).
P-17-57........................................              522651-48-5  Benzoic acid, 2,4,5-trifluoro-, sodium
                                                                           salt (1:1).
P-17-59........................................             1604819-08-0  Benzoic acid, 2,3-difluoro-, sodium
                                                                           salt (1:1).
P-17-61........................................               69226-41-1  Benzoic acid, 3-(trifluoromethyl)-,
                                                                           sodium salt (1:1).
P-17-62........................................               17264-74-3  Benzoic acid, 2-chloro-, sodium salt
                                                                           (1:1).
P-17-63........................................                3686-66-6  Benzoic acid, 4-chloro-, sodium salt
                                                                           (1:1).

[[Page 37730]]

 
P-17-64........................................               17264-88-9  Benzoic acid, 3-chloro-, sodium salt
                                                                           (1:1).
P-17-66........................................              118537-84-1  Benzoic acid, 2,3-dichloro-, sodium
                                                                           salt (1:1).
P-17-67........................................               63891-98-5  Benzoic acid, 2,5-dichloro-, sodium
                                                                           salt (1:1).
P-17-69........................................              154862-40-5  Benzoic acid, 3,5-dichloro-, sodium
                                                                           salt (1:1).
P-17-71........................................               10007-84-8  Benzoic acid, 2,6-dichloro-, sodium
                                                                           salt (1:1).
P-17-72........................................               17274-10-1  Benzoic acid, 3,4-dichloro-, sodium
                                                                           salt (1:1).
P-17-73........................................               38402-11-8  Benzoic acid, 2,4-dichloro-, sodium
                                                                           salt (1:1).
P-17-75........................................              855471-43-1  Benzoic acid, 2-chloro-4-fluoro-,
                                                                           sodium salt.
P-17-76........................................             1421761-18-3  Benzoic acid, 3-chloro-4-fluoro-,
                                                                           sodium salt.
P-17-79........................................             1382106-78-6  Benzoic acid, 5-chloro-2-fluoro-,
                                                                           sodium salt.
P-17-80........................................             1421029-88-0  Benzoic acid, 4-chloro-3-fluoro-,
                                                                           sodium salt.
P-17-83........................................             1382106-64-0  Benzoic acid, 4-chloro-2-fluoro-,
                                                                           sodium salt.
P-17-85........................................             1938142-12-1  Benzoic acid, 5-bromo-2-chloro-,
                                                                           sodium salt.
P-17-87........................................              938142-13-2  Benzoic acid, 3-bromo-4-fluoro-,
                                                                           sodium salt.
P-17-90........................................             1938142-14-3  Benzoic acid, 2-bromo-5-fluoro-,
                                                                           sodium salt.
P-17-91........................................             1938142-15-4  Benzoic acid, 4-bromo-2-fluoro-,
                                                                           sodium salt.
P-17-93........................................             1535169-81-3  Benzoic acid, 4-bromo-3-fluoro-,
                                                                           sodium salt.
----------------------------------------------------------------------------------------------------------------

    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (2)(i), (iv), (a)(3), when determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(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 of at least 50), (a)(6) 
(particulate), (a)(6)(v), (vi), (b) (concentration set at 1.0%), 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 0.0184 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 at 1.0%), (f), (g)(1)(i), 
(ii), (iii), (iv), (vi), (ix), (g)(2)(i), (ii), (iii), (use respiratory 
protection or maintain workplace airborne concentrations at or below an 
8-hour time-weighted average of 0.0184 mg/m\3\), (g)(2)(v), 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 manufacture or process the substances other than for the 
processes described in the Order.
    (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
34. Add Sec.  [emsp14]721.11054 to subpart E to read as follows:


Sec.  721.11054  Certain halogenated benzoic acids

    (a) The chemical substances listed in the Table of this section is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.

                                        Table--Halogenated Benzoic Acids
----------------------------------------------------------------------------------------------------------------
                    PMN No.                              CAS No.                       Chemical name
----------------------------------------------------------------------------------------------------------------
P-17-35........................................                1201-31-6  Benzoic acid, 2,3,4,5-tetrafluoro-.
P-17-37........................................                 433-97-6  Benzoic acid, 2-(trifluoromethyl)-.
P-17-40........................................                2991-28-8  Benzoic acid, 2,5-difluoro-.
P-17-44........................................                 385-00-2  Benzoic acid, 2,6-difluoro-.
P-17-46........................................                 455-40-3  Benzoic acid, 3,5-difluoro-.
P-17-48........................................                1583-58-0  Benzoic acid, 2,4-difluoro-.
P-17-51........................................                 455-86-7  Benzoic acid, 3,4-difluoro-.
P-17-53........................................              121602-93-5  Benzoic acid, 3,4,5-trifluoro-.
P-17-54........................................               61079-72-9  Benzoic acid, 2,3,4-trifluoro-.
P-17-56........................................                 446-17-3  Benzoic acid, 2,4,5-trifluoro-.
P-17-58........................................                4519-39-5  Benzoic acid, 2,3-difluoro-.
P-17-60........................................                 454-92-2  Benzoic acid, 3-(trifluoromethyl)-.
P-17-65........................................                  50-45-3  Benzoic acid, 2,3-dichloro-.
P-17-68........................................                  51-36-5  Benzoic acid, 3,5-dichloro-.
P-17-70........................................                  50-30-6  Benzoic acid, 2,6-dichloro-.

[[Page 37731]]

 
P-17-74........................................                2252-51-9  Benzoic acid, 2-chloro-4-fluoro-.
P-17-77........................................                 394-30-9  Benzoic acid, 5-chloro-2-fluoro-.
P-17-78........................................                 403-16-7  Benzoic acid, 3-chloro-4-fluoro-.
P-17-81........................................                 403-17-8  Benzoic acid, 4-chloro-3-fluoro-.
P-17-82........................................                 446-30-0  Benzoic acid, 4-chloro-2-fluoro-.
P-17-84........................................               21739-92-4  Benzoic acid, 5-bromo-2-chloro-.
P-17-88........................................               11007-16-5  Benzoic acid, 3-bromo-4-fluoro-.
P-17-89........................................                 394-28-5  Benzoic acid, 2-bromo-5-fluoro-.
P-17-92........................................              153556-42-4  Benzoic acid, 4-bromo-3-fluoro-.
P-17-97........................................              112704-79-7  Benzoic acid, 4-bromo-2-fluoro-.
----------------------------------------------------------------------------------------------------------------

    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (v), (a)(3), (4), when determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible, (a)(5) (respirators must provide a National Institute 
for Occupational Safety and Health (NIOSH) assigned protection factor 
of at least 50, (a)(6) (particulate), (a)(6)(v), (vi), (b) 
(concentration set at 1.0%), 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 0.0184 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 at 1.0%), (f), (g)(1)(i), 
(ii), (iii), (iv), (vi), (ix), (g)(2)(i), (ii), (iii), (use respiratory 
protection or maintain workplace airborne concentrations at or below an 
8-hour time-weighted average of 0.0184 mg/m\3\), (g)(2)(v), 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 (t). It is a significant new use to 
manufacture or process the substances other than for the processes 
described in the Order.
    (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
35. Add Sec.  [emsp14]721.11055 to subpart E to read as follows:


Sec.  721.11055  Certain halogenated benzoic acids ethyl esters.

    (a) The chemical substances listed in the Table of this section is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.

                                  Table--Halogenated Benzoic Acid Ethyl Esters
----------------------------------------------------------------------------------------------------------------
                    PMN No.                              CAS No.                       Chemical name
----------------------------------------------------------------------------------------------------------------
P-17-94........................................              122894-73-9  Benzoic acid, 2,3,4,5-tetrafluoro-,
                                                                           ethyl ester.
P-17-95........................................                 583-02-8  Benzoic acid, 4-(trifluoromethyl)-,
                                                                           ethyl ester.
P-17-96........................................                 577-62-8  Benzoic acid, 2-(trifluoromethyl)-,
                                                                           ethyl ester.
P-17-98........................................               19064-14-3  Benzoic acid, 2,6-difluoro-, ethyl
                                                                           ester.
P-17-99........................................                 708-25-8  Benzoic acid, 2,5-difluoro-, ethyl
                                                                           ester.
P-17-100.......................................              351354-50-2  Benzoic acid, 2,3,4-trifluoro-, ethyl
                                                                           ester.
P-17-101.......................................              351354-50-2  Benzoic acid, 2-bromo-5-fluoro-, ethyl
                                                                           ester.
P-17-102.......................................                 350-19-6  Benzoic acid, 3,5-difluoro-, ethyl
                                                                           ester.
P-17-103.......................................               76008-73-6  Benzoic acid, 5-bromo-2-chloro-, ethyl
                                                                           ester.
P-17-104.......................................                1128-76-3  Benzoic acid, 3-chloro-, ethyl ester.
P-17-105.......................................                7335-25-3  Benzoic acid, 2-chloro-, ethyl ester.
P-17-114.......................................              137521-81-4  Benzoic acid, 3-chloro-4-fluoro-,
                                                                           ethyl ester.
P-17-122.......................................              474709-71-2  Benzoic acid, 4-bromo-2-fluoro-, ethyl
                                                                           ester.
P-17-123.......................................              144267-97-0  Benzoic acid, 2-bromo-4,5-difluoro-,
                                                                           ethyl ester.
P-17-124.......................................             1130165-74-0  Benzoic acid, 4-bromo-3-fluoro-, ethyl
                                                                           ester.
P-17-125.......................................               23233-33-2  Benzoic acid, 3-bromo-4-fluoro-, ethyl
                                                                           ester.
P-17-126.......................................                4793-20-8  Benzoic acid, 4-chloro-2-fluoro-,
                                                                           ethyl ester.
P-17-127.......................................               35112-27-7  Benzoic acid, 2,5-dichloro-, ethyl
                                                                           ester.
P-17-128.......................................              203573-08-4  Benzoic acid, 4-chloro-3-fluoro-,
                                                                           ethyl ester.
P-17-129.......................................              167758-87-4  Benzoic acid, 2-chloro-4-fluoro-,
                                                                           ethyl ester.
P-17-130.......................................              773139-56-3  Benzoic acid, 5-chloro-2-fluoro-,
                                                                           ethyl ester.
P-17-131.......................................              108928-00-3  Benzoic acid, 2,4-difluoro-, ethyl
                                                                           ester.

[[Page 37732]]

 
P-17-132.......................................              144267-96-9  Benzoic acid, 3,4-difluoro-, ethyl
                                                                           ester.
P-17-133.......................................              495405-09-9  Benzoic acid, 3,4,5-trifluoro-, ethyl
                                                                           ester.
P-17-134.......................................              351354-41-1  Benzoic acid, 2,4,5-trifluoro-, ethyl
                                                                           ester.
P-17-135.......................................               76783-59-0  Benzoic acid, 3-(trifluoromethyl)-,
                                                                           ethyl ester.
P-17-136.......................................              773134-65-9  Benzoic acid, 2,3-difluoro-, ethyl
                                                                           ester.
P-17-137.......................................               81055-73-4  Benzoic acid, 2,6-dichloro-, ethyl
                                                                           ester.
P-17-138.......................................               91085-56-2  Benzoic acid, 3,5-dichloro-, ethyl
                                                                           ester.
P-17-139.......................................               56882-52-1  Benzoic acid, 2,4-dichloro-, ethyl
                                                                           ester.
P-17-140.......................................               28394-58-3  Benzoic acid, 3,4-dichloro-, ethyl
                                                                           ester.
----------------------------------------------------------------------------------------------------------------

    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (v), (a)(3), (4), when determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible, (a)(5) (respirators must provide a National Institute 
for Occupational Safety and Health (NIOSH) assigned protection factor 
of at least 1000), (a)(6) (particulate), (a)(6)(v), (vi), (b) 
(concentration set at 1.0%), 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 0.0184 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 at 1.0%), (f), (g)(1)(i), 
(ii), (iii), (iv), (vi), (ix), (g)(2)(i), (ii), (iii), (use respiratory 
protection or maintain workplace airborne concentrations at or below an 
8-hour time-weighted average of 0.0184 mg/m\3\), (g)(2)(v), (g)(3)(i), 
(ii), (g)(4)(i), 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 (t). It is a significant new use to 
manufacture or process the substances other than for processes 
described in the Order.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N = 15 ppb.
    (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
36. Add Sec.  [emsp14]721.11056 to subpart E to read as follows:


Sec.  721.11056  Neodymium aluminium alkyl polymer complexes (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
neodymium aluminium alkyl polymer complexes (PMN P-17-198) 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), (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%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set 1.0%), (f), (g)(1)(ix), (The 
substance may react violently with water, (This substance may cause 
skin irritation and corrosion), (This substance may cause respiratory 
complications, irritation, and corrosion), (g)(2)(i), (ii), (iii), 
(When using this substance use in closed system to prevent any 
inhalation exposure), (When using this substance use skin and eye 
protection), 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(c) (It is a significant new use to process 
the substance in manner that results in inhalation exposure.), (f), and 
(p) (8 months).
    (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
37. Add Sec.  [emsp14]721.11057 to subpart E to read as follows:


Sec.  721.11057  Fatty acid amide alkyl amine salts (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as fatty 
acid amide alkyl amine salts (PMN P-17-272, P-17-273, P-17-274, P-17-
275, P-17-276 and P-17-277) are subject to reporting under this section 
for the significant new uses described in paragraph (a)(2) of this 
section. The requirements of this section

[[Page 37733]]

do not apply to quantities of the substances after they have been 
reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (iii), (iv), (a)(3). When determining which 
persons are reasonably likely to be exposed as required 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.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1) (skin 
irritation), (respiratory complication), (internal organ effect), 
(systemic effect), (sensitization), (g)(2)(i), (ii), (iii), (v), 
(g)(3)(i), (ii), (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.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k), and (y)(1).
    (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
38. Add Sec.  [emsp14]721.11058 to subpart E to read as follows:


Sec.  721.11058  Fatty acid amide alkyl amine salts (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as fatty 
acid amide alkyl amine salts (PMN P-17-278, P-17-279 and P-17-280) are 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section. The requirements of this 
section do not apply to quantities of the substances after they have 
been reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (iii), (iv), (a)(3). When determining which 
persons are reasonably likely to be exposed as required 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.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1) (skin 
irritation), (respiratory complication), (internal organ effect), 
(systemic effect), (sensitization), (g)(2)(i), (ii), (iii), (v), 
(g)(3)(i), (ii), (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.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k), and (y)(1).
    (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.

[FR Doc. 2018-15995 Filed 7-31-18; 8:45 am]
 BILLING CODE 6560-50-P