83 FR 37702 - Significant New Use Rules on Certain Chemical Substances
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 83, Issue 148 (August 1, 2018)
Federal Register Volume 83, Issue 148 (August 1, 2018)
| Page Range | 37702-37733 | |
| FR Document | 2018-15995 |
[Federal Register Volume 83, Number 148 (Wednesday, August 1, 2018)] [Rules and Regulations] [Pages 37702-37733] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-15995] [[Page 37701]] Vol. 83 Wednesday, No. 148 August 1, 2018 Part III Environmental Protection Agency ----------------------------------------------------------------------- 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]] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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
![37702 Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Rules and Regulations
ENVIRONMENTAL PROTECTION or other information whose disclosure is at 40 CFR part 707, subpart B. In
AGENCY restricted by statute. addition, any persons who export or
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initiates EPA’s evaluation of the epa.gov. accordance with procedures set forth in
intended use within the applicable SUPPLEMENTARY INFORMATION: 40 CFR part 2.
review period. Persons may not 2. Tips for preparing your comments.
commence manufacture or processing I. General Information When preparing and submitting your
for the significant new use until EPA A. Does this action apply to me? comments, see the commenting tips at
has conducted a review of the notice, http://www.epa.gov/dockets/
You may be potentially affected by
made an appropriate determination on comments.html.
this action if you manufacture, process,
the notice, and has taken such actions or use the chemical substances II. Background
as are required with that determination. contained in this rule. The following list
DATES: This rule is effective on October A. What action is the Agency taking?
of North American Industrial
1, 2018. For purposes of judicial review, Classification System (NAICS) codes is 1. Direct Final Rule. EPA is
this rule shall be promulgated at 1 p.m. not intended to be exhaustive, but rather promulgating these SNURs using direct
(e.s.t.) on August 15, 2018. provides a guide to help readers final procedures. These SNURs will
Written adverse comments on one or determine whether this document require persons to notify EPA at least 90
more of these SNURs must be received applies to them. Potentially affected days before commencing the
on or before August 31, 2018 (see Unit entities may include: manufacture or processing of a chemical
VI. of the SUPPLEMENTARY INFORMATION). • Manufacturers or processors of one substance for any activity designated by
If EPA receives written adverse or more subject chemical substances these SNURs as a significant new use.
comments on one or more of these (NAICS codes 325 and 324110), e.g., Receipt of such notices obligates EPA to
SNURs before August 31, 2018, EPA chemical manufacturing and petroleum assess risks that may be associated with
will withdraw the relevant sections of refineries. the significant new uses under the
this direct final rule before its effective This action may also affect certain conditions of use and, if appropriate, to
date. entities through pre-existing import regulate the proposed uses before they
For additional information on related certification and export notification occur.
reporting requirement dates, see Units rules under TSCA. Chemical importers 2. Proposed Rule. In addition to this
I.A., VI., and VII. of the SUPPLEMENTARY are subject to the TSCA section 13 (15 Direct Final Rule, elsewhere in this
INFORMATION. U.S.C. 2612) import certification issue of the Federal Register, EPA is
ADDRESSES: Submit your comments, requirements promulgated at 19 CFR issuing a Notice of Proposed
identified by docket identification (ID) 12.118 through 12.127 and 19 CFR Rulemaking for this rule. If EPA receives
number EPA–HQ–OPPT–2017–0366, by 127.28. Chemical importers must certify no adverse comment, the Agency will
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one of the following methods: that the shipment of the chemical not take further action on the proposed
• Federal eRulemaking Portal: http:// substance complies with all applicable rule and the direct final rule will
www.regulations.gov. Follow the online rules and orders under TSCA. Importers become effective as provided in this
instructions for submitting comments. of chemicals subject to these SNURs action. If EPA receives adverse comment
Do not submit electronically any must certify their compliance with the on one or more of SNURs in this action
information you consider to be SNUR requirements. The EPA policy in by August 31, 2018 (see Unit VI. of the
Confidential Business Information (CBI) support of import certification appears SUPPLEMENTARY INFORMATION), the
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to the actual NCEL concentration, the evaluation of the human health effects CFR citations: 40 CFR 721.11024 (P–
comprehensive NCELs provisions in of the PMN substances. Further, the 14–472) and 40 CFR 721.11025 (P–14–
TSCA section 5(e) Orders, which are Order was issued under TSCA sections 496).
modeled after Occupational Safety and 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
PMN Number: P–14–630
Health Administration (OSHA) based on a finding that the substances
Permissible Exposure Limits (PELs) may present an unreasonable risk of Chemical name: Bismuth bromide
provisions, include requirements injury to human health and the iodide oxide.
addressing performance criteria for environment. To protect against these CAS number: 340181–06–8.
sampling and analytical methods, risks, the Order requires: Effective date of TSCA section 5(e)
periodic monitoring, respiratory 1. Submission of certain toxicity Order: May 10, 2017.
protection, and recordkeeping. testing on the PMN substances prior to Basis for TSCA section 5(e) Order:
However, no comparable NCEL exceeding the confidential production The PMN states that the substance will
provisions currently exist in 40 CFR volume limit as specified in the Order. be used as a pigment for liquid coatings
part 721, subpart B, for SNURs. 2. Use of personal protective solvent based system; a pigment for
Therefore, for these cases, the equipment to prevent dermal exposure. powder coatings; and a pigment for
individual SNURs in 40 CFR part 721, polymer materials. Based on test data
subpart E, will state that persons subject 3. Establishment and use of a hazard
communication program, including and physical/chemical properties of the
to the SNUR who wish to pursue NCELs PMN substance, as well as SAR analysis
as an alternative to the § 721.63 human health precautionary statements
on each label and in the Safety Data of analogous respirable, poorly soluble
respirator requirements may request to particulates, EPA identified concerns for
do so under § 721.30. EPA expects that Sheet (SDS).
lung effects, including fibrosis. The
persons whose § 721.30 requests to use 4. No release of the PMN substances Order was issued under TSCA sections
the NCELs approach for SNURs that are resulting in surface water 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
approved by EPA will be required to concentrations that exceed 3 ppb for P– based on insufficient information to
comply with NCELs provisions that are 14–472 and 4 ppb for P–14–496. make a reasoned evaluation and a
comparable to those contained in the 5. No modification of the finding that the substance may present
corresponding TSCA section 5(e) Order manufacturing process that results in an unreasonable risk of injury to human
for the same chemical substance. inhalation exposure and no use health. EPA assessed risks based on the
involving application methods that specific manufacturing, processing, use,
PMN Numbers: P–14–472 and P–14–496
generate a dust, mist, or aerosol. distribution/transportation, treatment
Chemical names: Polyphosphoric 6. Use of the PMN substances only as and disposal processes, process
acids, 2-[alkyl-1-oxo-2-propen-1- a site-limited intermediate (P–14–472) equipment, engineering controls, and
yl)oxy]ethyl esters, compds. with N- and the confidential use specified in the handling practices (including worker
(aminoiminomethyl)urea (generic) (P– Order (P–14–496). activities and cleaning procedures)
14–472) and Polyphosphoric acids, 2-
[(2-methyl-1-oxo-2-propen-1- The SNUR would designate as a described in the PMN. To protect
yl)oxy]ethyl esters, compds. with alkyl ‘‘significant new use’’ the absence of against these risks, the Order requires:
amino, polymers with Bu acrylate, N- these protective measures. 1. Submission of certain toxicity
(hydroxymethyl)propenamide and Potentially useful information: EPA testing on the PMN substance prior to
styrene (generic) (P–14–496). has determined that certain information exceeding the confidential production
CAS numbers: Not available. about the fate and human health toxicity volume limit as specified in the Order.
Effective date of TSCA section 5(e) of the PMN substances may be 2. Use of a National Institute for
Order: April 26, 2017. potentially useful to characterize the Occupational Safety and Health
Basis for TSCA section 5(e) Order: effects of the PMN substances in (NIOSH)-certified respirator with an
The PMN states that the generic (non- support of a request by the PMN Assigned Protection Factor (APF) of at
confidential) uses of the PMN submitter to modify the Order, or if a least 10 (where there is a potential for
substances are as a site-controlled manufacturer or processor is inhalation exposures) or compliance
intermediate (P–14–472) and a paper considering submitting a SNUN for a with a New Chemical Exposure Limit
additive (P–14–496). Based on Structure significant new use that will be (NCEL) of 2.4 milligram/meter3 (mg/m3)
Activity Relationship (SAR) analysis of designated by this SNUR. The submitter as an 8-hour time-weighted average.
test data on acrylates/methacrylates, and has agreed not to exceed the 3. Establishment and use of a hazard
other structurally similar substances, confidential production limit without communication program, including
there is potential for irritation and performing a skin sensitization study human health precautionary statements
sensitization for P–14–472. For P–14– and a biodegradation test on each on each label and in the SDS.
496 there is concern for sensitization substance. In addition, EPA has 4. No use of the substance in a
based on the presence of formaldehyde determined that the results of a consumer product that generates a dust,
and concern for irritation and lung pulmonary effects testing of the PMN mist, or aerosol.
effects from the surfactant properties of substance may be potentially useful in The SNUR will designate as a
the substance. Further, based on SAR characterizing the health effects of the ‘‘significant new use’’ the absence of
analysis of test data on analogous PMN substances. Although the Order these protective measures, and any use
phosphates, EPA predicts toxicity to does not require this additional testing, to vary or alter, the manufacturing,
aquatic organisms may occur at the Order’s restrictions on manufacture, processing, use, distribution/
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concentrations that exceed 3 parts per processing, distribution in commerce, transportation, treatment and disposal
billion (ppb) of P–14–472 and 4 ppb of and disposal will remain in effect until processes, process equipment,
P–14–496 in surface waters. The Order the Order is modified or revoked by engineering controls, and handling
was issued under TSCA sections EPA based on submission of this or practices (including worker activities
5(a)(3)(B)(i) and 5(e)(1)(A)(i), based on a other information that EPA determines and cleaning procedures) described in
finding that the available information is is relevant and needed to evaluate a the PMN in such a way as to change the
insufficient to permit a reasoned modification request. magnitude of inhalation exposure.
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2. Manufacture of the PMN substance health and the environment. To protect acid, diazotized substituted aromatic
such that the solid particle form has a against these risks, the Order requires: sulfonate, diazotized substituted
particle size distribution where less 1. Submission of certain toxicity aromatic sulfonate, metal salts (generic)
than 1% of the particles are less than 10 testing on the PMN substance prior to (P–16–339); Carbon black, (organic
microns. exceeding the confidential production acidic carbocyclic)-modified, inorganic
The SNUR will designate as a volume limit as specified in the Order. salt (generic) (P–16–439); and Carbon
‘‘significant new use’’ the absence of 2. Use of personal protective black, (organic acidic carbocyclic)-
these protective measures. equipment to prevent dermal exposure modified, metal salt (generic) (P–16–
Potentially useful information: EPA (where there is a potential for dermal 440).
has determined that certain information exposure). CAS numbers: Not available.
about the physical/chemical 3. Use of a NIOSH-certified respirator Effective date of TSCA section 5(e)
characteristics of the PMN substance with an APF of at least 25 (where there Order: April 11, 2017.
may be potentially useful to characterize is a potential for inhalation exposure) or Basis for TSCA section 5(e) Order:
the health effects of the PMN substance compliance with a NCEL of 1.2 ppm as The PMN states that the generic (non-
in support of a request by the PMN an 8-hour time-weighted average. (EPA’s confidential) uses of the PMN
submitter to modify the Order, or if a estimates indicate that variations of the substances will be as dyestuffs (P–16–
manufacturer or processor is parameters (including batch size, 0338 and P–16–0339) and as coloring
considering submitting a SNUN for a number of processing sites, days per agents (P–16–0439 and P–16–0440).
significant new use that will be year of operation) of the uses identified Based on physical/chemical properties
designated by this SNUR. The submitter below would not result in inhalation of the PMN substances and test data on
has agreed not to manufacture beyond a exposure that would indicate a different analogous poorly respirable particles,
certain time period without measuring respirator.) EPA has identified concerns for
the particle size distribution to 4. Establishment and use of a hazard irritation to the eyes, lungs, and mucous
characterize the fraction of the dry communication program, including membranes, and lung effects. Further,
particle PMN substance less than 10 human health precautionary statements based on SAR analysis of test data on
microns. In addition, EPA has on each label and in the SDS. analogous dyes, EPA predicts toxicity to
determined that the results of specific 5. No domestic manufacture of the aquatic organisms may occur at
target organ toxicity testing of the PMN PMN substance. concentrations that exceed 200 ppb of
6. Process and use of the PMN the PMN substances in surface waters.
substance may be potentially useful in
substance only for the confidential uses The Order was issued under TSCA
characterizing the health effects of the
and formulation percentage specified in sections 5(a)(3)(B)(ii)(I) and
PMN substance. Although the Order
the Order. 5(e)(1)(A)(ii)(I), based on insufficient
does not require this additional testing, 7. No release of the PMN substance
the Order’s restrictions on manufacture, information to make a reasoned
resulting in surface water evaluation and a finding that the
processing, distribution in commerce, concentrations that exceed 18 ppb.
and disposal will remain in effect until substances may present an unreasonable
The SNUR will designate as a risk of injury to human health and the
the Order is modified or revoked by ‘‘significant new use’’ the absence of
EPA based on submission of this or environment. To protect against these
these protective measures. risks, the Order requires:
other information that EPA determines Potentially useful information: EPA 1. No manufacture of the PMN
is relevant and needed to evaluate a has determined that certain information substances beyond the confidential
modification request. about the human health and aquatic annual production volume specified in
CFR citation: 40 CFR 721.11032. toxicity of the PMN substance may be the Order.
PMN Number: P–16–322 potentially useful to characterize the 2. No domestic manufacture of the
effects of the PMN substance in support PMN substances.
Chemical name: Manganese cyclic of a request by the PMN submitter to 3. Import the PMN substances only
(tri)amine chloride complex (generic). modify the Order, or if a manufacturer according to the terms specified and for
CAS number: Not available. or processor is considering submitting a the confidential uses specified in the
Effective date of TSCA section 5(e) SNUN for a significant new use that will Order.
Order: April 25, 2017. be designated by this SNUR. The 4. No release of the PMN substances
Basis for TSCA section 5(e) Order: submitter has agreed not to exceed the to surface waters.
The PMN states that the generic (non- confidential production limit without The SNUR will designate as a
confidential) use of the substance will performing specific target organ toxicity ‘‘significant new use’’ the absence of
be as a pulp bleaching catalyst. Based testing, reproductive/developmental these protective measures.
on test data on an analog, EPA has toxicity testing; and chronic aquatic Potentially useful information: EPA
identified concerns for kidney, blood, toxicity testing. has determined that certain information
and thyroid effects, immunotoxicity, CFR citation: 40 CFR 721.11033. about the fate, human health toxicity,
reproductive and developmental and aquatic toxicity of the PMN
toxicity, and neurotoxicity. Based on PMN Numbers: P–16–338, P–16–339, substances may be potentially useful to
test data on the PMN substance, EPA P–16–439, and P–16–440 characterize the effects of the PMN
estimates that toxicity to aquatic Chemical names: Xanthylium, substances in support of a request by the
organisms may occur at concentrations (sulfoaryl)-bis [(substituted aryl) PMN submitter to modify the Order, or
that exceed 18 ppb of the PMN amino]-, sulfo derivs., inner salts, metal if a manufacturer or processor is
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substance in surface waters. The Order salts (generic) (P–16–338); Substituted considering submitting a SNUN for a
was issued under TSCA sections triazinyl metal salt, diazotized, coupled significant new use that will be
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), with substituted designated by this SNUR. EPA has
based on insufficient information to pyridobenzimidazolesulfonic acids, determined that the results of a
make a reasoned evaluation and a substituted biodegradation test, specific target organ
finding that the substance may present pyridobenzimidazolesulfonic acids, toxicity testing, and acute and chronic
an unreasonable risk of injury to human diazotized substituted alkanesulfonic aquatic toxicity testing of the PMN
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![37708 Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Rules and Regulations
substances may be potentially useful in in support of a request by the PMN (where there is a potential for dermal
characterizing the health and submitter to modify the Order, or if a exposure).
environmental effects of the PMN manufacturer or processor is 3. Establishment and use of a hazard
substances. Although the Order does not considering submitting a SNUN for a communication program, including
require these tests, the Order’s significant new use that will be human health precautionary statements
restrictions on manufacture, processing, designated by this SNUR. EPA has on each label and in the SDS.
distribution in commerce, and disposal determined that the results of specific 4. No domestic manufacture of the
will remain in effect until the Order is target organ toxicity testing and a PMN substances.
modified or revoked by EPA based on sensitization test of the PMN substance 5. No manufacture of the PMN
submission of this or other information may be potentially useful in substances beyond an annual
that EPA determines is relevant and characterizing the health effects of the production volume of 250 kg/yr.
needed to evaluate a modification PMN substance. Although the Order 6. No use of the PMN substances in
request. does not require these tests, the Order’s application methods that generate a
CFR citations: 40 CFR 721.11034 (P– restrictions on manufacture, processing, dust, mist, or aerosol.
16–338), 40 CFR 721.11035 (P–16–339), distribution in commerce, and disposal 7. No release of the PMN substance
40 CFR 721.11036 (P–16–439), and 40 will remain in effect until the Order is resulting in surface water
CFR 721.11037 (P–16–440). modified or revoked by EPA based on concentrations that exceed 1 ppb.
submission of this or other information The SNUR will designate as a
PMN Number: P–16–350 ‘‘significant new use’’ the absence of
that EPA determines is relevant and
Chemical name: Polyaralkyl aryl ester needed to evaluate a modification these protective measures.
of methacrylic acid (generic). request. Potentially useful information: EPA
CAS number: Not available. CFR citation: 40 CFR 721.11038. has determined that certain information
Effective date of TSCA section 5(e) about the human health and aquatic
Order: March 31, 2017. PMN Number: P–16–352 toxicity of the PMN substance may be
Basis for TSCA section 5(e) Order: Chemical names: Phenol, 2-[[[3- potentially useful to characterize the
The PMN states that the generic (non- (octyloxy)propyl]imino]methyl]- (P–16– effects of the PMN substance in support
confidential) use of the substance will 352, chemical A) and Phenol, 2-[[[3- of a request by the PMN submitter to
be as a polymer reactant. Based on test (decyloxy)propyl]imino]methyl]- (P–16– modify the Order, or if a manufacturer
data on methacrylate moieties, EPA has 352, chemical B). or processor is considering submitting a
identified concerns for irritation and SNUN for a significant new use that will
CAS numbers: 1858221–49–4 (P–16–
sensitization based on analogy to be designated by this SNUR. The
352, chemical A) and 1858221–50–7 (P–
methacrylates. Based on SAR analysis of submitter has agreed not to exceed the
16–352, chemical B).
test data on structurally similar confidential production limit without
Effective date of TSCA section 5(e)
respirable surfactants, EPA has performing specific target organ toxicity,
Order: April 21, 2017.
identified concerns for lung effects. The reproductive/developmental toxicity,
Order was issued under TSCA sections Basis for TSCA section 5(e) Order:
and acute aquatic toxicity testing.
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), The PMN states that the PMN
CFR citations: 40 CFR 721.11039 (P–
based on insufficient information to substances will be used as co-catalysts
16–352, chemical A) and 40 CFR
make a reasoned evaluation and a in the manufacturing of release coatings
721.11040 (P–16–352, chemical B).
finding that the substance may present for producing papers and films at a
concentration of 1% or less. Based on PMN Number: P–16–358
an unreasonable risk of injury to human
health. To protect against these risks, SAR analysis of test data on analogous Chemical name: Alkyl phenol
the Order requires: phenols, EPA has identified concerns (generic).
1. Use of personal protective for respiratory and dermal irritation and CAS number: Not available.
equipment including impervious gloves developmental toxicity. In addition, Effective date of TSCA section 5(e)
(where there is a potential for dermal EPA has identified concerns for liver Order: April 24, 2017.
exposure). toxicity and reproductive effects based Basis for TSCA section 5(e) Order:
2. Establishment and use of a hazard on the hydrolysis product o- The PMN states that the substance will
communication program, including hydroxybenzaldehyde. Further, based be used as a chemical intermediate.
human health precautionary statements on SAR analysis of test data on Based on SAR analysis of test data on
on each label and in the SDS. analogous phenols, EPA predicts analogous phenols, EPA has identified
3. Manufacture of the PMN substance toxicity to aquatic organisms may occur concerns for developmental toxicity.
such that it is not less than the at concentrations that exceed 1 ppb of The Order was issued under TSCA
minimum average molecular weight the PMN substances in surface waters. sections 5(a)(3)(B)(ii)(I) and
identified in the Order and does not The Order was issued under TSCA 5(e)(1)(A)(ii)(I), based on insufficient
contain more than the maximum weight sections 5(a)(3)(B)(ii)(I) and information to make a reasoned
percent of low molecular weight species 5(e)(1)(A)(ii)(I), based on insufficient evaluation and a finding that the
below 1,000 Daltons. information to make a reasoned substance may present an unreasonable
4. Use of the PMN substance only for evaluation and a finding that the risk of injury to human health. To
the confidential use specified in the substances may present an unreasonable protect against these risks, the Order
Order. risk of injury to human health and the requires:
The SNUR will designate as a environment. To protect against these 1. Submission of certain toxicity
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‘‘significant new use’’ the absence of risks, the Order requires: testing on the PMN substance prior to
these protective measures. 1. Submission of certain toxicity exceeding the confidential production
Potentially useful information: EPA testing on the PMN substance prior to volume limit as specified in the Order.
has determined that certain information exceeding the confidential production 2. Use of personal protective
about the toxicity of the PMN substance volume limit as specified in the Order. equipment including impervious gloves
may be potentially useful to characterize 2. Use of personal protective (where there is a potential for dermal
the health effects of the PMN substance equipment including impervious gloves exposure).
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includes the time needed to review requirements of UMRA sections 202, Populations and Low-Income
instructions, search existing data 203, 204, or 205 (2 U.S.C. 1501 et seq.). Populations’’ (59 FR 7629, February 16,
sources, gather and maintain the data 1994).
E. Executive Order 13132
needed, and complete, review, and
This action will not have a substantial XIII. Congressional Review Act
submit the required SNUN.
Send any comments about the direct effect on States, on the Pursuant to the Congressional Review
accuracy of the burden estimate, and relationship between the national Act (5 U.S.C. 801 et seq.), EPA will
any suggested methods for minimizing government and the States, or on the submit a report containing this rule and
respondent burden, including through distribution of power and other required information to the U.S.
the use of automated collection responsibilities among the various Senate, the U.S. House of
techniques, to the Director, Collection levels of government, as specified in Representatives, and the Comptroller
Strategies Division, Office of Executive Order 13132, entitled General of the United States prior to
Environmental Information (2822T), ‘‘Federalism’’ (64 FR 43255, August 10, publication of the rule in the Federal
Environmental Protection Agency, 1200 1999). Register. This action is not a ‘‘major
Pennsylvania Ave. NW, Washington, DC rule’’ as defined by 5 U.S.C. 804(2).
F. Executive Order 13175
20460–0001. Please remember to List of Subjects
include the OMB control number in any This action does not have Tribal
correspondence, but do not submit any implications because it is not expected 40 CFR Part 9
completed forms to this address. to have substantial direct effects on
Indian Tribes. This action does not Environmental protection, Reporting
C. Regulatory Flexibility Act (RFA) significantly nor uniquely affect the and recordkeeping requirements.
On February 18, 2012, EPA certified communities of Indian Tribal 40 CFR Part 721
pursuant to RFA section 605(b) (5 U.S.C. governments, nor does it involve or Environmental protection, Chemicals,
601 et seq.), that promulgation of a impose any requirements that affect Hazardous substances, Reporting and
SNUR does not have a significant Indian Tribes. Accordingly, the recordkeeping requirements.
economic impact on a substantial requirements of Executive Order 13175,
entitled ‘‘Consultation and Coordination Dated: July 19, 2018.
number of small entities where the
with Indian Tribal Governments’’ (65 FR Jeffery T. Morris,
following are true:
1. A significant number of SNUNs 67249, November 9, 2000), do not apply Director, Office of Pollution Prevention and
to this action. Toxics.
would not be submitted by small
entities in response to the SNUR. G. Executive Order 13045 Therefore, 40 CFR parts 9 and 721 are
2. The SNUR submitted by any small amended as follows:
This action is not subject to Executive
entity would not cost significantly more
Order 13045, entitled ‘‘Protection of PART 9—[AMENDED]
than $8,300.
Children from Environmental Health
A copy of that certification is
Risks and Safety Risks’’ (62 FR 19885, ■ 1. The authority citation for part 9
available in the docket for this action.
April 23, 1997), because this is not an continues to read as follows:
This action is within the scope of the economically significant regulatory
February 18, 2012 certification. Based Authority: 7 U.S.C. 135 et seq., 136–136y;
action as defined by Executive Order 15 U.S.C. 2001, 2003, 2005, 2006, 2601–2671;
on the Economic Analysis discussed in 12866, and this action does not address 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33
Unit XI. and EPA’s experience environmental health or safety risks U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318,
promulgating SNURs (discussed in the disproportionately affecting children. 1321, 1326, 1330, 1342, 1344, 1345(d) and
certification), EPA believes that the (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,
following are true: H. Executive Order 13211 1971–1975 Comp. p. 973; 42 U.S.C. 241,
• A significant number of SNUNs This action is not subject to Executive 242b, 243, 246, 300f, 300g, 300g–1, 300g–2,
would not be submitted by small Order 13211, entitled ‘‘Actions 300g–3, 300g–4, 300g–5, 300g–6, 300j–1,
entities in response to the SNUR. 300j–2, 300j–3, 300j–4, 300j–9, 1857 et seq.,
Concerning Regulations That 6901–6992k, 7401–7671q, 7542, 9601–9657,
• Submission of the SNUN would not Significantly Affect Energy Supply, 11023, 11048.
cost any small entity significantly more Distribution, or Use’’ (66 FR 28355, May
than $8,300. ■ 2. In § 9.1, add the following sections
22, 2001), because this action is not
Therefore, the promulgation of the in numerical order under the
expected to affect energy supply,
SNUR would not have a significant undesignated center heading
distribution, or use and because this
economic impact on a substantial ‘‘Significant New Uses of Chemical
action is not a significant regulatory
number of small entities. Substances’’ to read as follows:
action under Executive Order 12866.
D. Unfunded Mandates Reform Act I. National Technology Transfer and § 9.1 OMB approvals under the Paperwork
(UMRA) Reduction Act.
Advancement Act (NTTAA)
* * * * *
Based on EPA’s experience with In addition, since this action does not
proposing and finalizing SNURs, State, involve any technical standards, OMB
local, and Tribal governments have not NTTAA section 12(d) (15 U.S.C. 272 40 CFR citation control No.
been impacted by these rulemakings, note), does not apply to this action.
and EPA does not have any reasons to
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believe that any State, local, or Tribal J. Executive Order 12898 * * * * *
government will be impacted by this This action does not entail special
Significant New Uses of Chemical
action. As such, EPA has determined considerations of environmental justice Substances
that this action does not impose any related issues as delineated by
enforceable duty, contain any unfunded Executive Order 12898, entitled
mandate, or otherwise have any effect ‘‘Federal Actions to Address * * * * *
on small governments subject to the Environmental Justice in Minority 721.11024 ............................. 2070–0012
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![37720 Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Rules and Regulations
OMB (g)(2)(i), (v), (g)(3)(i), (ii), (g)(4)(i), and is a significant new use to have
40 CFR citation control No. (g)(5). Alternative hazard and warning manufacturing activities that result in
statements that meet the criteria of the inhalation exposure.
721.11025 ............................. 2070–0012 Globally Harmonized System (GHS) and (iv) Release to water. Requirements as
721.11026 ............................. 2070–0012 OSHA Hazard Communication Standard specified in § 721.90(a)(4), (b)(4), and
721.11027 ............................. 2070–0012
may be used. (c)(4) where N = 4.
721.11028 ............................. 2070–0012
721.11029 ............................. 2070–0012 (iii) Industrial, commercial, and (b) Specific requirements. The
721.11030 ............................. 2070–0012 consumer activities. Requirements as provisions of subpart A of this part
721.11031 ............................. 2070–0012 specified in § 721.80(h), (q), and (y)(1). apply to this section except as modified
721.11032 ............................. 2070–0012 It is a significant new use to have by this paragraph.
721.11033 ............................. 2070–0012 manufacturing activities that result in (1) Recordkeeping. Recordkeeping
721.11034 ............................. 2070–0012 inhalation exposure. requirements as specified in
721.11035 ............................. 2070–0012 (iv) Release to water. Requirements as § 721.125(a) through (i) and (k) are
721.11036 ............................. 2070–0012 specified in § 721.90(a)(4), (b)(4), and applicable to manufacturers and
721.11037 ............................. 2070–0012 processors of this substance.
721.11038 ............................. 2070–0012
(c)(4) where N = 3.
(b) Specific requirements. The (2) Limitations or revocation of
721.11039 ............................. 2070–0012
provisions of subpart A of this part certain notification requirements. The
721.11040 ............................. 2070–0012
721.11041 ............................. 2070–0012 apply to this section except as modified provisions of § 721.185 apply to this
721.11042 ............................. 2070–0012 by this paragraph. section.
721.11043 ............................. 2070–0012 (1) Recordkeeping. Recordkeeping (3) Determining whether a specific use
721.11044 ............................. 2070–0012 requirements as specified in is subject to this section. The provisions
721.11045 ............................. 2070–0012 § 721.125(a) through (i) and (k) are of § 721.1725(b)(1) apply to paragraph
721.11046 ............................. 2070–0012 applicable to manufacturers and (a)(2)(iii) of this section.
721.11047 ............................. 2070–0012 processors of this substance. ■ 6. Add § 721.11026 to subpart E to
721.11048 ............................. 2070–0012
(2) Limitations or revocation of read as follows:
721.11049 ............................. 2070–0012
721.11050 ............................. 2070–0012 certain notification requirements. The
§ 721.11026 Bismuth bromide iodide
721.11051 ............................. 2070–0012 provisions of § 721.185 apply to this oxide.
721.11052 ............................. 2070–0012 section.
(3) Determining whether a specific use (a) Chemical substance and
721.11053 ............................. 2070–0012
721.11054 ............................. 2070–0012 is subject to this section. The provisions significant new uses subject to reporting.
721.11055 ............................. 2070–0012 of § 721.1725(b)(1) apply to paragraph (1) The chemical substance identified as
721.11056 ............................. 2070–0012 (a)(2)(iii) of this section. bismuth bromide iodide oxide (PMN P–
721.11057 ............................. 2070–0012 14–630, CAS No. 340181–06–8) is
■ 5. Add § 721.11025 to subpart E to
721.11058 ............................. 2070–0012 subject to reporting under this section
read as follows: for the significant new uses described in
* * * * * paragraph (a)(2) of this section. The
§ 721.11025 Polyphosphoric acids, 2-[(2-
methyl-1-oxo-2-propen-1-yl)oxy]ethyl requirements of this section do not
* * * * * esters, compds. with alkyl amino, polymers apply to quantities of the substance after
with Bu acrylate, N- they have been reacted (cured).
PART 721—[AMENDED] (hydroxymethyl)propenamide and styrene (2) The significant new uses are:
(generic). (i) Protection in the workplace.
■ 3. The authority citation for part 721
continues to read as follows: (a) Chemical substance and Requirements as specified in
significant new uses subject to reporting. § 721.63(a)(4), when determining which
Authority: 15 U.S.C. 2604, 2607, and (1) The chemical substance identified persons are reasonably likely to be
2625(c).
generically as polyphosphoric acids, 2- exposed as required for § 721.63(a)(4),
■ 4. Add § 721.11024 to subpart E to [(2-methyl-1-oxo-2-propen-1- engineering control measures (e.g.,
read as follows: yl)oxy]ethyl esters, compds. with alkyl enclosure or confinement of the
§ 721.11024 Polyphosphoric acids, 2- amino, polymers with Bu acrylate, N- operation, general and local ventilation)
[alkyl-1-oxo-2-propen-1-yl)oxy]ethyl esters, (hydroxymethyl)propenamide and or administrative control measures (e.g.,
compds. with N-(aminoiminomethyl)urea styrene (PMN P–14–496) is subject to workplace policies and procedures)
(generic). reporting under this section for the shall be considered and implemented to
(a) Chemical substance and significant new uses described in prevent exposure, where feasible,
significant new uses subject to reporting. paragraph (a)(2) of this section. (a)(5)(respirators must provide a
(1) The chemical substance identified (2) The significant new uses are: National Institute for Occupational
generically as polyphosphoric acids, 2- (i) Protection in the workplace. Safety and Health (NIOSH) assigned
[alkyl-1-oxo-2-propen-1-yl)oxy]ethyl Requirements as specified in protection factor (APF) of at least 10),
esters, compds. with N- § 721.63(a)(1), (3), and (c). (a)(6)(i) (particulate), (b) (concentration
(aminoiminomethyl)urea (PMN P–14– (ii) Hazard communication. set at 1.0%), and (c).
472) is subject to reporting under this Requirements as specified in (A) As an alternative to the respirator
section for the significant new uses § 721.72(a), through (f), (g)(1)(i), (ii), requirements in paragraph (a)(2)(i) of
described in paragraph (a)(2) of this (sensitization), (g)(2)(i), (v), (g)(3)(i), (ii), this section, a manufacturer or processor
section. and (g)(5). Alternative hazard and may choose to follow the new chemical
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(2) The significant new uses are: warning statements that meet the exposure limit (NCEL) provision listed
(i) Protection in the workplace. criteria of the Globally Harmonized in the TSCA section 5(e) Order for this
Requirements as specified in System (GHS) and OSHA Hazard substance. The NCEL is 2.4 mg/m3 as an
§ 721.63(a)(1), (3), and (c). Communication Standard may be used. 8-hour time weighted average. Persons
(ii) Hazard communication. (iii) Industrial, commercial, and who wish to pursue NCELs as an
Requirements as specified in § 721.72(a) consumer activities. Requirements as alternative to § 721.63 respirator
through (f), (g)(1)(i), (ii), (sensitization), specified in § 721.80(k), (q) and (y)(1). It requirements may request to do so
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under § 721.30. Persons whose § 721.30 determining which persons are release this chemical substance to air
requests to use the NCELs approach are reasonably likely to be exposed as unless using the chemical transfer and
approved by EPA will be required to required for § 721.63(a)(1) and (4), air ventilation processes described in P–
follow NCELs provisions comparable to engineering control measures (e.g., 15–0450 including filtering through a
those contained in the corresponding enclosure or confinement of the high-efficiency particular air filter with
TSCA section 5(e) Order. operation, general and local ventilation) an efficiency rate of 99.99% before
(B) [Reserved] or administrative control measures (e.g., release to air.
(ii) Hazard communication. workplace policies and procedures) (b) Specific requirements. The
Requirements as specified in § 721.72(a) shall be considered and implemented to provisions of subpart A of this part
through (e) (concentration set at 1.0%), prevent exposure, where feasible, (a)(5) apply to this section except as modified
(f), (g)(1)(ii), (g)(2)(ii), (use respiratory (respirators must provide a National by this paragraph.
protection or maintain workplace Institute for Occupational Safety and (1) Recordkeeping. Recordkeeping
airborne concentrations at or below an Health (NIOSH) assigned protection requirements as specified in
8-hour time-weighted average of 2.4 mg/ factor (APF) of at least 1,000), (a)(6) § 721.125(a) through (j) are applicable to
m3), and (g)(5). Alternative hazard and (particulate) (b) (concentration set at manufacturers and processors of this
warning statements that meet the 0.1%), and (c). It is a significant new use substance.
criteria of the Globally Harmonized to manufacture or process the substance (2) Limitations or revocation of
System (GHS) and OSHA Hazard without the chemical transfer processes certain notification requirements. The
Communication Standard may be used. and air ventilation processes described provisions of § 721.185 apply to this
(iii) Industrial, commercial, and in the PMN and the exposure section.
consumer activities. Requirements as monitoring requirements described in (3) Determining whether a specific use
specified in § 721.80(q). It is a the Order. is subject to this section. The provisions
significant new use to vary or alter, the (A) As an alternative to the respirator of § 721.1725(b)(1) apply to paragraph
manufacturing, processing, and use, requirements in paragraph (a)(2)(i) of (a)(2)(iii) of this section.
distribution/transportation, treatment this section, a manufacturer or processor ■ 8. Add § 721.11028 to subpart E to
and disposal processes, process may choose to follow the new chemical read as follows:
equipment, engineering controls, and exposure limit (NCEL) provision listed
in the TSCA section 5(e) Order for this § 721.11028 Alkylarylamine (generic).
handling practices (including worker
activities and cleaning procedures) substance. The NCEL is 0.000092 mg/m3 (a) Chemical substance and
described in the PMN in such a way as as an 8-hour time weighted average. significant new uses subject to reporting.
to change the magnitude of inhalation Persons who wish to pursue NCELs as (1) The chemical substance identified
exposure. It is a significant new use to an alternative to § 721.63 respirator generically as alkylarylamine (PMN P–
use the substance for a consumer requirements may request to do so 15–705) is subject to reporting under
product that generates a dust, mist, or under § 721.30. Persons whose § 721.30 this section for the significant new uses
aerosol. requests to use the NCELs approach are described in paragraph (a)(2) of this
(b) Specific requirements. The approved by EPA will be required to section.
provisions of subpart A of this part follow NCELs provisions comparable to (2) The significant new uses are:
apply to this section except as modified those contained in the corresponding (i) Protection in the workplace.
by this paragraph. TSCA section 5(e) Order. Requirements as specified in
(1) Recordkeeping. Recordkeeping (B) [Reserved] § 721.63(a)(1), (a)(2)(i), (ii), (iii), (a)(3),
requirements as specified in (ii) Hazard communication. and (4), when determining which
§ 721.125(a) through (d), and (f) through Requirements as specified in § 721.72(a) persons are reasonably likely to be
(i) are applicable to manufacturers and through (e) (concentration set 0.1%), (f), exposed as required for § 721.63(a)(1)
processors of this substance. (g)(1)(ii), (This substance may cause and (4), engineering control measures
(2) Limitations or revocation of damage to the lung, kidney, and spleen), (e.g., enclosure or confinement of the
certain notification requirements. The (g)(1)(vii), (g)(2)(i), (ii), (iii), (When operation, general and local ventilation)
provisions of § 721.185 apply to this using this substance wear protective or administrative control measures (e.g.,
section. gloves/protective clothing/eye workplace policies and procedures)
(3) Determining whether a specific use protection/face protection), the shall be considered and implemented to
is subject to this section. The provisions following human health precautionary prevent exposure, where feasible, (a)(5)
of § 721.1725(b)(1) apply to paragraph statement must appear on the SDS as (respirators must provide a National
(a)(2)(iii) of this section. specified in paragraph (a)(2)(ii): (When Institute for Occupational Safety and
■ 7. Add § 721.11027 to subpart E to using this substance use respiratory Health (NIOSH) assigned protection
read as follows: protection or maintain workplace factor (APF) of at least 1,000),
airborne concentrations at or below an (a)(6)(particulate), (a)(6)(v), (vi), (b)
§ 721.11027 Aluminum cobalt lithium 8-hour time-weighted average of (concentration set at 0.1%), and (c).
nickel oxide. 0.000092 mg/m3), (g)(2)(v), and (g)(5). (A) As an alternative to the respirator
(a) Chemical substance and Alternative hazard and warning requirements in paragraph (a)(2)(i) of
significant new uses subject to reporting. statements that meet the criteria of the this section, a manufacturer or processor
(1) The chemical substance identified as Globally Harmonized System (GHS) and may choose to follow the new chemical
aluminum cobalt lithium nickel oxide OSHA Hazard Communication Standard exposure limit (NCEL) provision listed
(PMN P–15–450, CAS No. 177997–13–6) may be used. in the TSCA section 5(e) Order for this
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is subject to reporting under this section (iii) Industrial, commercial, and substance. The NCEL is 0.48 mg/m3 as
for the significant new uses described in consumer activities. Requirements as an 8-hour time weighted average.
paragraph (a)(2) of this section. specified in § 721.80(p) (24 months and Persons who wish to pursue NCELs as
(2) The significant new uses are: 6 years). an alternative to § 721.63 respirator
(i) Protection in the workplace. (iv) Disposal. Requirements as requirements may request to do so
Requirements as specified in specified in § 721.85(a)(2), (b)(2), and under § 721.30. Persons whose § 721.30
§ 721.63(a)(1), (3), (4), when (c)(2). It is a significant new use to requests to use the NCELs approach are
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![37722 Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Rules and Regulations
approved by EPA will be required to persons are reasonably likely to be (3) Determining whether a specific use
follow NCELs provisions comparable to exposed as required for § 721.63(a)(1) is subject to this section. The provisions
those contained in the corresponding and (4), engineering control measures of § 721.1725(b)(1) apply to paragraph
TSCA section 5(e) Order. (e.g., enclosure or confinement of the (a)(2)(iii) of this section.
(B) [Reserved] operation, general and local ventilation) ■ 10. Add § 721.11030 to subpart E to
(ii) Hazard communication. or administrative control measures (e.g., read as follows:
Requirements as specified in § 721.72(a) workplace policies and procedures)
through (e) (concentration set at 0.1%), shall be considered and implemented to § 721.11030 Aliphatic N-alkyl urea polymer
(f), (g)(1)(i), (ii), (iv), (vi), (vii), (ix), prevent exposure, where feasible, (a)(5) containing aspartic ester groups and
trimethoxy silanes (generic).
(g)(2)(i), (ii), (iii), (use respiratory (respirators must provide a National
protection or maintain workplace Institute for Occupational Safety and (a) Chemical substance and
airborne concentrations at or below an Health (NIOSH) assigned protection significant new uses subject to reporting.
8-hour time-weighted average of 0.48 factor (APF) of at least 10), (a)(6) (1) The chemical substance identified
mg/m3), (g)(2)(v), (g)(3)(ii), (g)(4)(i), and (particulate), (a)(6)(v), (vi), (b) generically as aliphatic N-alkyl urea
(g)(5). Alternative hazard and warning (concentration set at 1.0%), and (c). polymer containing aspartic ester
statements that meet the criteria of the (A) As an alternative to the respirator groups and trimethoxy silanes (PMN P–
Globally Harmonized System (GHS) and requirements in paragraph (a)(2)(i) of 15–707) is subject to reporting under
OSHA Hazard Communication Standard this section, a manufacturer or processor this section for the significant new uses
may be used. may choose to follow the new chemical described in paragraph (a)(2) of this
(iii) Industrial, commercial, and exposure limit (NCEL) provision listed section. The requirements of this section
consumer activities. Requirements as in the TSCA section 5(e) Order for this do not apply to quantities of the
specified in § 721.80(o) and (q). It is a substance. The NCEL is 0.9 mg/m3 as an substance after they have been reacted
significant new use to use the substance 8-hour time weighted average. Persons (cured).
other than as a chemical intermediate or who wish to pursue NCELs as an (2) The significant new uses are:
as an additive and octane booster in alternative to § 721.63 respirator (i) Protection in the workplace.
aviation fuels. requirements may request to do so Requirements as specified in
(iv) Release to water. Requirements as under § 721.30. Persons whose § 721.30 § 721.63(a)(1), (a)(2)(i), (iii), (iv), (a)(3),
specified in § 721.90(a)(4), (b)(4), and requests to use the NCELs approach are (4), when determining which persons
(c)(4) where N = 1. approved by EPA will be required to are reasonably likely to be exposed as
(b) Specific requirements. The follow NCELs provisions comparable to required for § 721.63(a)(1) and (4),
provisions of subpart A of this part those contained in the corresponding engineering control measures (e.g.,
apply to this section except as modified TSCA section 5(e) Order. enclosure or confinement of the
by this paragraph. (B) [Reserved] operation, general and local ventilation)
(1) Recordkeeping. Recordkeeping (ii) Hazard communication. or administrative control measures (e.g.,
requirements as specified in Requirements as specified in § 721.72(a) workplace policies and procedures)
§ 721.125(a) through (i), and (k) are through (e) (concentration set at 1.0%), shall be considered and implemented to
applicable to manufacturers and (f), (g)(1)(ii), (ix), (g)(2)(i), (ii), (iii), (use prevent exposure, where feasible, (a)(5)
processors of this substance. respiratory protection or maintain (respirators must provide a National
(2) Limitations or revocation of workplace airborne concentrations at or Institute for Occupational Safety and
certain notification requirements. The below an 8-hour time-weighted average Health (NIOSH) assigned protection
provisions of § 721.185 apply to this of 0.9 mg/m3), (g)(2)(v), and (g)(5). factor (APF) of at least 10), (a)(6)(i), (v),
section. Alternative hazard and warning (vi), (b) (concentration set at 1.0%), and
(3) Determining whether a specific use statements that meet the criteria of the (c).
is subject to this section. The provisions Globally Harmonized System (GHS) and (A) As an alternative to the respirator
of § 721.1725(b)(1) apply to paragraph OSHA Hazard Communication Standard requirements in paragraph (a)(2)(i) of
(a)(2)(iii) of this section. may be used. this section, a manufacturer or processor
■ 9. Add § 721.11029 to subpart E to (iii) Industrial, commercial, and may choose to follow the new chemical
read as follows: consumer activities. Requirements as exposure limit (NCEL) provision listed
specified in § 721.80(k), (o), (p) (594,000 in the TSCA section 5(e) Order for this
§ 721.11029 Aliphatic N-alkyl urea polymer kilograms, P–15–706 and P–15–707 substance. The NCEL is 0.9 mg/m3 as an
containing cyclohexyl groups and combined), and (t)(250,000 kilograms, 8-hour time weighted average. Persons
trimethoxy silanes (generic). P–15–706 and P–15–707 combined). A who wish to pursue NCELs as an
(a) Chemical substance and significant new use is any manufacture, alternative to § 721.63 respirator
significant new uses subject to reporting. processing, or use of the PMN substance requirements may request to do so
(1) The chemical substance identified with more than 0.1% residual under § 721.30. Persons whose § 721.30
generically as aliphatic N-alkyl urea isocyanate by weight. requests to use the NCELs approach are
polymer containing cyclohexyl groups (b) Specific requirements. The approved by EPA will be required to
and trimethoxy silanes (PMN P–15–706) provisions of subpart A of this part follow NCELs provisions comparable to
is subject to reporting under this section apply to this section except as modified those contained in the corresponding
for the significant new uses described in by this paragraph. TSCA section 5(e) Order.
paragraph (a)(2) of this section. The (1) Recordkeeping. Recordkeeping (B) [Reserved]
requirements of this section do not requirements as specified in (ii) Hazard communication.
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apply to quantities of the substance after § 721.125(a) through (i) are applicable to Requirements as specified in § 721.72(a)
they have been reacted (cured). manufacturers and processors of this through (e) (concentration set at 1.0%),
(2) The significant new uses are: substance. (f), (g)(1)(ii), (g)(1)(ix), (g)(2)(i), (ii), (iii),
(i) Protection in the workplace. (2) Limitations or revocation of (use respiratory protection or maintain
Requirements as specified in certain notification requirements. The workplace airborne concentrations at or
§ 721.63(a)(1), (a)(2)(i),(iii), (iv), (a)(3) provisions of § 721.185 apply to this below an 8-hour time-weighted average
and (4), when determining which section. of 0.9 mg/m3), (g)(2)(v), and (g)(5).
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Alternative hazard and warning and warning statements that meet the provisions of § 721.185 apply to this
statements that meet the criteria of the criteria of the Globally Harmonized section.
Globally Harmonized System (GHS) and System (GHS) and OSHA Hazard ■ 13. Add § 721.11033 to subpart E to
OSHA Hazard Communication Standard Communication Standard may be used. read as follows:
may be used. (iii) Industrial, commercial, and
(iii) Industrial, commercial, and consumer activities. Requirements as § 721.11033 Manganese cyclic (tri)amine
consumer activities. Requirements as specified in § 721.80(f). It is a significant chloride complex (generic).
specified in § 721.80(k), (o), (p) (594,000 new use to use the substances for the (a) Chemical substance and
kilograms, P–15–706 and P–15–707 uses specified in the Order, at a significant new uses subject to reporting.
combined), and (t) (250,000 kilograms, concentration greater than 3% of the (1) The chemical substance identified
P–15–706 and P–15–707 combined). A metal working fluid, and use other than generically as manganese cyclic
significant new use is any manufacture, the closed metal working systems as (tri)amine chloride complex (PMN P–
processing, or use of the PMN substance specified in the PMNs with no 16–322) is subject to reporting under
with more than 1% residual isocyanate modifications in the process that would this section for the significant new uses
by weight. result in worker inhalation exposure. described in paragraph (a)(2) of this
(b) Specific requirements. The (iv) Release to water. Requirements as section. The requirements of this section
provisions of subpart A of this part specified in § 721.90(a)(4), (b)(4), and do not apply to quantities of the
apply to this section except as modified (c)(4) where N = 10. substance after they have been reacted
by this paragraph. (b) Specific requirements. The (cured).
(1) Recordkeeping. Recordkeeping provisions of subpart A of this part (2) The significant new uses are:
requirements as specified in apply to this section except as modified (i) Protection in the workplace.
§ 721.125(a) through (i) are applicable to by this paragraph. Requirements as specified in
manufacturers and processors of this (1) Recordkeeping. Recordkeeping § 721.63(a)(1), (3), (4), when
substance. requirements as specified in determining which persons are
(2) Limitations or revocation of § 721.125(a) through (i), and (k) are reasonably likely to be exposed as
certain notification requirements. The applicable to manufacturers and required for § 721.63(a)(1) and (4),
provisions of § 721.185 apply to this processors of this substance. engineering control measures (e.g.,
section. (2) Limitations or revocation of enclosure or confinement of the
(3) Determining whether a specific use certain notification requirements. The operation, general and local ventilation)
is subject to this section. The provisions provisions of § 721.185 apply to this or administrative control measures (e.g.,
of § 721.1725(b)(1) apply to paragraph section. workplace policies and procedures)
(a)(2)(iii) of this section. (3) Determining whether a specific use shall be considered and implemented to
is subject to this section. The provisions prevent exposure, where feasible, (a)(5)
■ 11. Add § 721.11031 to subpart E to
of § 721.1725(b)(1) apply to paragraph (respirators must provide a National
read as follows: (a)(2)(iii) of this section. Institute for Occupational Safety and
§ 721.11031 Alkyl heteromonocycle, ■ 12. Add § 721.11032 to subpart E to Health (NIOSH) assigned protection
polymer with heteromonocycle, read as follows: factor (APF) of at least 25), (a)(6)(i),
carboxyalkyl alkyl ether (generic). (particulate), (b) (concentration set at
§ 721.11032 Benzene dicarboxylic acid,
(a) Chemical substances and polymer with alkane dioic acid and aliphatic 1.0%), and (c).
significant new uses subject to reporting. diamine (generic). (A) As an alternative to the respirator
(1) The chemical substances identified requirements in paragraph (a)(2)(i) of
(a) Chemical substance and
generically as alkyl heteromonocycle, this section, a manufacturer or processor
significant new uses subject to reporting.
polymer with heteromonocycle, may choose to follow the new chemical
(1) The chemical substance identified as
carboxyalkyl alkyl ether (PMNs P–16– generically as benzene dicarboxylic exposure limit (NCEL) provision listed
273 and P–16–0274) are subject to acid, polymer with alkane dioic acid in the TSCA section 5(e) Order for this
reporting under this section for the and aliphatic diamine (PMN P–16–289) substance. The NCEL is 1.2 mg/m3 as an
significant new uses described in is subject to reporting under this section 8-hour time weighted average. Persons
paragraph (a)(2) of this section. for the significant new uses described in who wish to pursue NCELs as an
(2) The significant new uses are: paragraph (a)(2) of this section. alternative to § 721.63 respirator
(i) Protection in the workplace. (2) The significant new uses are: requirements may request to do so
Requirements as specified in (i) Industrial, commercial, and under § 721.30. Persons whose § 721.30
§ 721.63(a)(1), (a)(2)(i), (iii), (a)(3), (b) consumer activities. Requirements as requests to use the NCELs approach are
(concentration set at 1.0%), and (c). specified in § 721.80(k)(Manufacture approved by EPA will be required to
When determining which persons are only in a form with a particle size follow NCELs provisions comparable to
reasonably likely to be exposed as distribution where less than 1.0 percent those contained in the corresponding
required for § 721.63(a)(1), engineering of the particles are less than 10 microns) TSCA section 5(e) Order.
control measures (e.g., enclosure or and (p) (six months). (B) [Reserved]
confinement of the operation, general (ii) [Reserved] (ii) Hazard communication.
and local ventilation) or administrative (b) Specific requirements. The Requirements as specified in § 721.72(a)
control measures (e.g., workplace provisions of subpart A of this part through (e) (concentration set at 1.0%),
policies and procedures) shall be apply to this section except as modified (f), (g)(1)(iv), (vi), (viii), (ix), (g)(2)(i), (ii),
considered and implemented to prevent by this paragraph. (iii), (use respiratory protection or
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exposure, where feasible. (1) Recordkeeping. Recordkeeping maintain workplace airborne
(ii) Hazard communication. requirements as specified in concentrations at or below an 8-hour
Requirements as specified in § 721.72(a) § 721.125(a) through (c), and (i) are time-weighted average of 1.2 mg/m3),
through (e) (concentration set at 1.0%), applicable to manufacturers and (v), (g)(3) (This substance may be toxic
(f), (g)(1)(i), (ii), (dermal sensitization), processors of this substance. to algae. This substance may be harmful
(g)(2)(i), (ii), (iii), and (v), (g)(3)(i), (ii), (2) Limitations or revocation of to invertebrates), (g)(4)(i), (ii), (do not
(g)(4)(iii), and (g)(5). Alternative hazard certain notification requirements. The release to water to yield surface water
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![37724 Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Rules and Regulations
concentrations above 18 ppb.), and ■ 15. Add § 721.11035 to subpart E to (i) Industrial, commercial, and
(g)(5). Alternative hazard and warning read as follows: consumer activities. Requirements as
statements that meet the criteria of the specified in § 721.80(f), (k), and (t).
Globally Harmonized System (GHS) and § 721.11035 Substituted triazinyl metal (ii) Release to water. Requirements as
salt, diazotized, coupled with substituted
OSHA Hazard Communication Standard pyridobenzimidazolesulfonic acids,
specified in § 721.90(a)(1), (b)(1), and
may be used. substituted pyridobenzimidazolesulfonic (c)(1).
(iii) Industrial, commercial, and acids, diazotized substituted alkanesulfonic (b) Specific requirements. The
consumer activities. Requirements as acid, diazotized substituted aromatic provisions of subpart A of this part
specified in § 721.80(f), (k), and (q). sulfonate, diazotized substituted aromatic apply to this section except as modified
(iv) Release to water. Requirements as sulfonate, metal salts (generic). by this paragraph.
specified in § 721.90(a)(4), (b)(4), and (a) Chemical substance and (1) Recordkeeping. Recordkeeping
(c)(4) where N = 18. significant new uses subject to reporting. requirements as specified in
(b) Specific requirements. The (1) The chemical substance identified § 721.125(a) through (c), (i), and (k) are
provisions of subpart A of this part generically as substituted triazinyl metal applicable to manufacturers and
apply to this section except as modified salt, diazotized, coupled with processors of this substance.
by this paragraph. substituted (2) Limitations or revocation of
(1) Recordkeeping. Recordkeeping pyridobenzimidazolesulfonic acids, certain notification requirements. The
requirements as specified in substituted provisions of § 721.185 apply to this
§ 721.125(a) through (i), and (k) are pyridobenzimidazolesulfonic acids, section.
applicable to manufacturers and diazotized substituted alkanesulfonic (3) Determining whether a specific use
processors of this substance. acid, diazotized substituted aromatic is subject to this section. The provisions
(2) Limitations or revocation of sulfonate, diazotized substituted of § 721.1725(b)(1) apply to paragraph
certain notification requirements. The aromatic sulfonate, metal salts (PMN P– (a)(2)(i) of this section.
provisions of § 721.185 apply to this 16–339) is subject to reporting under ■ 17. Add § 721.11037 to subpart E to
section. this section for the significant new uses read as follows:
(3) Determining whether a specific use
described in paragraph (a)(2) of this § 721.11037 Carbon black, (organic acidic
is subject to this section. The provisions
section. carbocyclic)-modified, metal salt (generic).
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section. (2) The significant new uses are: (a) Chemical substance and
(i) Industrial, commercial, and significant new uses subject to reporting.
■ 14. Add § 721.11034 to subpart E to
consumer activities. Requirements as (1) The chemical substance identified
read as follows:
specified in § 721.80(f), (k), and (t). generically as carbon black, (organic
§ 721.11034 Xanthylium, (sulfoaryl)-bis (ii) Release to water. Requirements as acidic carbocyclic)-modified, metal salt
[(substituted aryl) amino]-, sulfo derivs., specified in § 721.90(a)(1), (b)(1), and (PMN P–16–440) is subject to reporting
inner salts, metal salts (generic). (c)(1). under this section for the significant
(a) Chemical substance and (b) Specific requirements. The new uses described in paragraph (a)(2)
significant new uses subject to reporting. provisions of subpart A of this part of this section.
(1) The chemical substance identified apply to this section except as modified (2) The significant new uses are:
generically as xanthylium, (sulfoaryl)- by this paragraph. (i) Industrial, commercial, and
bis [(substituted aryl) amino]-, sulfo (1) Recordkeeping. Recordkeeping consumer activities. Requirements as
derivs., inner salts, metal salts (PMN requirements as specified in specified in § 721.80(f), (k), and (t).
P–16–338) is subject to reporting under § 721.125(a), (b), (c), (i), and (k) are (ii) Release to water. Requirements as
this section for the significant new uses applicable to manufacturers and specified in § 721.90(a)(1), (b)(1), and
described in paragraph (a)(2) of this processors of this substance. (c)(1).
section. (b) Specific requirements. The
(2) Limitations or revocation of
(2) The significant new uses are: provisions of subpart A of this part
certain notification requirements. The
(i) Industrial, commercial, and apply to this section except as modified
provisions of § 721.185 apply to this
consumer activities. Requirements as by this paragraph.
section.
specified in § 721.80(f), (k), and (t). (1) Recordkeeping. Recordkeeping
(ii) Release to water. Requirements as (3) Determining whether a specific use requirements as specified in
specified in § 721.90(a)(1), (b)(1), and is subject to this section. The provisions § 721.125(a) through (c), (i), and (k) are
(c)(1). of § 721.1725(b)(1) apply to paragraph applicable to manufacturers and
(b) Specific requirements. The (a)(2)(i) of this section. processors of this substance.
provisions of subpart A of this part ■ 16. Add § 721.11036 to subpart E to (2) Limitations or revocation of
apply to this section except as modified read as follows: certain notification requirements. The
by this paragraph. provisions of § 721.185 apply to this
(1) Recordkeeping. Recordkeeping § 721.11036 Carbon black, (organic acidic
section.
requirements as specified in carbocyclic)-modified, inorganic salt
(generic).
(3) Determining whether a specific use
§ 721.125(a), (b), (c), (i), and (k) are is subject to this section. The provisions
applicable to manufacturers and (a) Chemical substance and of § 721.1725(b)(1) apply to paragraph
processors of this substance. significant new uses subject to reporting. (a)(2)(i) of this section.
(2) Limitations or revocation of (1) The chemical substance identified
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■ 18. Add § 721.11038 to subpart E to
certain notification requirements. The generically as carbon black, (organic read as follows:
provisions of § 721.185 apply to this acidic carbocyclic)-modified, inorganic
section. salt (PMN P–16–439) is subject to § 721.11038 Polyaralkyl aryl ester of
(3) Determining whether a specific use reporting under this section for the methacrylic acid (generic).
is subject to this section. The provisions significant new uses described in (a) Chemical substance and
of § 721.1725(b)(1) apply to paragraph paragraph (a)(2) of this section. significant new uses subject to reporting.
(a)(2)(i) of this section. (2) The significant new uses are: (1) The chemical substance identified as
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![Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Rules and Regulations 37725
generically as polyaralkyl aryl ester of new uses described in paragraph (a)(2) (i) Protection in the workplace.
methacrylic acid (PMN P–16–350) is of this section. Requirements as specified in
subject to reporting under this section (2) The significant new uses are: § 721.63(a)(1), (a)(2)(i), (a)(3), (a)(6)(v),
for the significant new uses described in (i) Protection in the workplace. (vi), (particulate), (b) (concentration set
paragraph (a)(2) of this section. Requirements as specified in at 1.0%), and (c). When determining
(2) The significant new uses are: § 721.63(a)(1), (a)(2)(i), (a)(3), (a)(6)(v), which persons are reasonably likely to
(i) Protection in the workplace. (vi), (particulate), (b) (concentration set be exposed as required for § 721.63(a)(1)
Requirements as specified in at 1.0%), and (c). When determining engineering control measures (e.g.,
§ 721.63(a)(1), (a)(2)(i), (a)(3), when which persons are reasonably likely to enclosure or confinement of the
determining which persons are be exposed as required for § 721.63(a)(1) operation, general and local ventilation)
reasonably likely to be exposed as engineering control measures (e.g., or administrative control measures (e.g.,
required for § 721.63(a)(1), engineering enclosure or confinement of the workplace policies and procedures)
control measures (e.g., enclosure or operation, general and local ventilation) shall be considered and implemented to
confinement of the operation, general or administrative control measures (e.g., prevent exposure, where feasible.
and local ventilation) or administrative workplace policies and procedures) (ii) Hazard communication.
control measures (e.g., workplace shall be considered and implemented to Requirements as specified in § 721.72(a)
policies and procedures) shall be prevent exposure, where feasible. through (e) (concentration set at 1.0%),
considered and implemented to prevent (ii) Hazard communication. (f), (g)(1)(i), (iv), (vi), (ix), (g)(2)(i), (v),
exposure, where feasible, and (c). Requirements as specified in § 721.72 (g)(3)(i), (ii), and (g)(5). Alternative
(ii) Hazard communication. (a) through (e) (concentration set at hazard and warning statements that
Requirements as specified in § 721.72(a) 1.0%), (f), (g)(1)(i), (iv), (vi), (ix), meet the criteria of the Globally
through (d), (f), (g)(1)(i), (ii), (g)(2)(i), (v), (g)(3)(i), (ii), and (g)(5). Harmonized System (GHS) and OSHA
(sensitization), (mutagenicity); (g)(2)(i), Alternative hazard and warning Hazard Communication Standard may
(ii), (iii), (v), and (g)(5). Alternative statements that meet the criteria of the be used.
hazard and warning statements that Globally Harmonized System (GHS) and (iii) Industrial, commercial, and
meet the criteria of the Globally OSHA Hazard Communication Standard consumer activities. Requirements as
Harmonized System (GHS) and OSHA may be used. specified in § 721.80(f), (p) (10,500 and
Hazard Communication Standard may (iii) Industrial, commercial, and 13,000 kilograms respectively for the
be used. consumer activities. Requirements as total of this substance and the substance
(iii) Industrial, commercial, and specified in § 721.80(f), (p) (10,500 and subject to § 721.9998), (t) (250 kilograms
consumer activities. Requirements as 13,000 kilograms, respectively, for the for the total of this substance and the
specified in § 721.80(k). It is a total of this substance and the substance substance subject to § 721.9998), and
significant new use to manufacture the subject to 721.11039), (t) (250 kilograms (y)(1).
substance lower than the minimum for the total of this substance and the (iv) Release to water. Requirements as
average molecular weight identified in substance subject to 721.11039), and specified in § 721.90(a)(4), (b)(4), and
the Order and to contain more than the (y)(1). (c)(4) where N = 1.
maximum weight percent of low (b) Specific requirements. The
(iv) Release to water. Requirements as
molecular weight species below 1,000 provisions of subpart A of this part
specified in § 721.90(a)(4), (b)(4), and
daltons identified in the Order. apply to this section except as modified
(c)(4) where N = 1.
(b) Specific requirements. The by this paragraph.
(b) Specific requirements. The (1) Recordkeeping. Recordkeeping
provisions of subpart A of this part
provisions of subpart A of this part requirements as specified in
apply to this section except as modified
apply to this section except as modified § 721.125(a) through (i), and (k) are
by this paragraph.
(1) Recordkeeping. Recordkeeping by this paragraph. applicable to manufacturers and
requirements as specified in (1) Recordkeeping. Recordkeeping processors of this substance.
§ 721.125(a) through (i) are applicable to requirements as specified in (2) Limitations or revocation of
manufacturers and processors of this § 721.125(a) through (i), and (k) are certain notification requirements. The
substance. applicable to manufacturers and provisions of § 721.185 apply to this
(2) Limitations or revocation of processors of this substance. section.
certain notification requirements. The (2) Limitations or revocation of ■ 21. Add § 721.11041 to subpart E to
provisions of § 721.185 apply to this certain notification requirements. The read as follows:
section. provisions of § 721.185 apply to this
(3) Determining whether a specific use section. § 721.11041 Alkyl phenol (generic).
is subject to this section. The provisions ■ 20. Add § 721.11040 to subpart E to (a) Chemical substance and
of § 721.1725(b)(1) apply to paragraph read as follows: significant new uses subject to reporting.
(a)(2)(iii) of this section. (1) The chemical substance identified
§ 721.11040 Phenol, 2-[[[3- generically as alkyl phenol (PMN P–16–
■ 19. Add § 721.11039 to subpart E to
(decyloxy)propyl]imino]methyl]-. 358) is subject to reporting under this
read as follows:
(a) Chemical substance and section for the significant new uses
§ 721.11039 Phenol, 2-[[[3- significant new uses subject to reporting. described in paragraph (a)(2) of this
(octyloxy)propyl]imino]methyl]-. (1) The chemical substance identified as section.
(a) Chemical substance and phenol, 2-[[[3- (2) The significant new uses are:
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significant new uses subject to reporting. (decyloxy)propyl]imino]methyl]- (PMN (i) Protection in the workplace.
(1) The chemical substance identified as P–16–352, chemical B; CAS No. Requirements as specified in
phenol, 2-[[[3- 1858221–50–7) is subject to reporting § 721.63(a)(1), (a)(2)(i), (iii), (iv), (a)(3),
(octyloxy)propyl]imino]methyl]- (PMN under this section for the significant when determining which persons are
P–16–352, chemical A; CAS No. new uses described in paragraph (a)(2) reasonably likely to be exposed as
1858221–49–4) is subject to reporting of this section. required for § 721.63(a)(1) engineering
under this section for the significant (2) The significant new uses are: control measures (e.g., enclosure or
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![Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Rules and Regulations 37727
of § 721.1725(b)(1) apply to paragraph ■ 26. Add § 721.11046 to subpart E to (1) The chemical substance identified
(a)(2)(iii) of this section. read as follows: generically as alkyl alkenoic acid,
■ 25. Add § 721.11045 to subpart E to polymer with alkenylcarbomonocycle
§ 721.11046 Hydroxy alkylbiphenyl telomer with substituted alkanoic acid
read as follows: (generic).
hydroxyl alkyl substituted alkenyl
§ 721.11045 2-Pentanol, 4-methyl-, reaction (a) Chemical substance and substituted alkyl ester, polyalkylene
products with phosphorus oxide (P2O5), significant new uses subject to reporting. glycol alkyl ether alkyl alkenoate,
compounds with alkylamine (generic). (1) The chemical substance identified dialkylene glycol diheteromonocyclic
(a) Chemical substance and generically as hydroxy alkylbiphenyl ether and alkylcarbomonocyclic
significant new uses subject to reporting. (PMN P–16–513) is subject to reporting alkenoate, metal salt (PMN P–16–534) is
(1) The chemical substance identified as under this section for the significant subject to reporting under this section
generically as 2-pentanol, 4-methyl-, new uses described in paragraph (a)(2) for the significant new uses described in
reaction products with phosphorus of this section. paragraph (a)(2) of this section.
oxide (P2O5), compounds with (2) The significant new uses are: (2) The significant new uses are:
alkylamine (PMN P–16–495) is subject (i) Protection in the workplace.
(i) Industrial, commercial, and
to reporting under this section for the Requirements as specified in
consumer activities. Requirements as
significant new uses described in § 721.63(a)(1), (3), (4), when
specified in § 721.80(f) and (k). It is a
paragraph (a)(2) of this section. determining which persons are
significant new use to manufacture the
(2) The significant new uses are: reasonably likely to be exposed as
substance such that the lowest number
(i) Protection in the workplace. required for § 721.63(a)(1) and (4),
average molecular weight is less than
Requirements as specified in engineering control measures (e.g.,
1,800 daltons and the carboxylic acid
§ 721.63(a)(1), (3), when determining enclosure or confinement of the
content exceeds 20 percent).
which persons are reasonably likely to operation, general and local ventilation)
(ii) [Reserved]
be exposed as required for § 721.63(a)(1) or administrative control measures (e.g.,
(b) Specific requirements. The
engineering control measures (e.g., workplace policies and procedures)
provisions of subpart A of this part
enclosure or confinement of the shall be considered and implemented to
apply to this section except as modified
operation, general and local ventilation) prevent exposure, where feasible, (a)(5)
by this paragraph.
or administrative control measures (e.g., (respirators must provide a National
(1) Recordkeeping. Recordkeeping
workplace policies and procedures) Institute for Occupational Safety and
requirements as specified in
shall be considered and implemented to Health (NIOSH) assigned protection
§ 721.125(a) through (c), and (i) are
prevent exposure, where feasible, (a)(6) factor (APF) of at least 50), (a)(6)(i), (v),
applicable to manufacturers and
(particulate), (b) (concentration set at (vi), (b) (concentration set at 1.0%), and
processors of this substance.
1.0%), and (c). (c).
(2) Limitations or revocation of
(ii) Hazard communication. (ii) Industrial, commercial, and
certain notification requirements. The
Requirements as specified in § 721.72(a) consumer activities. Requirements as
provisions of § 721.185 apply to this
through (e) (concentration set at 1.0%), specified in § 721.80(g) and (q).
(iii) Release to water. Requirements as section.
(f), (g)(1)(i), (ii), (iv), (g)(2)(i), (ii), (v), (3) Determining whether a specific use
(g)(3)(i), (ii), (g)(4)(i), and (g)(5). specified in § 721.90(a)(4), (b)(4), and
(c)(4) where N = 17. is subject to this section. The provisions
Alternative hazard and warning of § 721.1725(b)(1) apply to paragraph
statements that meet the criteria of the (b) Specific requirements. The
provisions of subpart A of this part (a)(2)(iii) of this section.
Globally Harmonized System (GHS) and
apply to this section except as modified ■ 28. Add § 721.11048 to subpart E to
OSHA Hazard Communication Standard
may be used. by this paragraph. read as follows:
(iii) Industrial, commercial, and (1) Recordkeeping. Recordkeeping
§ 721.11048 Alkyl alkenoic acid, polymer
consumer activities. Requirements as requirements as specified in with alkenylcarbomonocycle telomer with
specified in § 721.80(q) and (y)(1). A § 721.125(a) through (e), (i), and (k) are substituted alkanoic acid hydroxyl alkyl
significant new use is any manner or applicable to manufacturers and substituted alkenyl substituted alkyl ester,
method of manufacturing that results in processors of this substance. alkanediol diheteromonocyclic ether,
inhalation exposure. (2) Limitations or revocation of polyalkylene glycol alkyl ether alkyl
(iv) Release to water. Requirements as certain notification requirements. The alkenoate and alkylcarbomonocyclic
specified in § 721.90(a)(4), (b)(4), and provisions of § 721.185 apply to this alkenoate, metal salt (generic).
(c)(4) where N = 200. section. (a) Chemical substance and
(b) Specific requirements. The (3) Determining whether a specific use significant new uses subject to reporting.
provisions of subpart A of this part is subject to this section. The provisions (1) The chemical substance identified
apply to this section except as modified of § 721.1725(b)(1) apply to paragraph generically as alkyl alkenoic acid,
by this paragraph. (a)(2)(ii) of this section. polymer with alkenylcarbomonocycle
(1) Recordkeeping. Recordkeeping ■ 27. Add § 721.11047 to subpart E to telomer with substituted alkanoic acid
requirements as specified in read as follows: hydroxyl alkyl substituted alkenyl
§ 721.125(a) through (i), and (k) are substituted alkyl ester, alkanediol
§ 721.11047 Alkyl alkenoic acid, polymer diheteromonocyclic ether, polyalkylene
applicable to manufacturers and
with alkenylcarbomonocycle telomer with
processors of this substance. glycol alkyl ether alkyl alkenoate and
substituted alkanoic acid hydroxyl alkyl
(2) Limitations or revocation of alkylcarbomonocyclic alkenoate, metal
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substituted alkenyl substituted alkyl ester,
certain notification requirements. The polyalkylene glycol alkyl ether alkyl salt (PMN P–16–535) is subject to
provisions of § 721.185 apply to this alkenoate, dialkylene glycol reporting under this section for the
section. diheteromonocyclic ether and significant new uses described in
(3) Determining whether a specific use alkylcarbomonocyclic alkenoate, metal salt paragraph (a)(2) of this section.
is subject to this section. The provisions (generic). (2) The significant new uses are:
of § 721.1725(b)(1) apply to paragraph (a) Chemical substance and (i) Industrial, commercial, and
(a)(2)(iii) of this section. significant new uses subject to reporting. consumer activities. Requirements as
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![37728 Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Rules and Regulations
specified in § 721.80(f) and (k). It is a § 721.11049 Alkyl alkenoic acid, polymer (ii) [Reserved]
significant new use to manufacture the with bis heteromonocyclic substituted alkyl
carbomonocycle, alkenylcarbomonocycle (b) Specific requirements. The
substance such that the lowest number provisions of subpart A of this part
telomer with substituted alkanoic acid
average molecular weight is less than hydroxyl alkyl substituted alkenyl apply to this section except as modified
1,800 daltons and the carboxylic acid substituted alkyl ester, polyalkylene glycol by this paragraph.
content exceeds 20 percent). alkyl ether alkyl alkenoate and
(1) Recordkeeping. Recordkeeping
(ii) [Reserved] alkylcarbomonocyclic alkenoate, metal salt
(generic). requirements as specified in
(b) Specific requirements. The § 721.125(a) through (c), and (i) are
(a) Chemical substance and
provisions of subpart A of this part applicable to manufacturers and
significant new uses subject to reporting.
apply to this section except as modified processors of this substance.
(1) The chemical substance identified
by this paragraph. generically as alkyl alkenoic acid, (2) Limitations or revocation of
(1) Recordkeeping. Recordkeeping polymer with bis heteromonocyclic certain notification requirements. The
requirements as specified in substituted alkyl carbomonocycle, provisions of § 721.185 apply to this
§ 721.125(a) through (c), and (i) are alkenylcarbomonocycle telomer with section.
applicable to manufacturers and substituted alkanoic acid hydroxyl alkyl (3) Determining whether a specific use
processors of this substance. substituted alkenyl substituted alkyl is subject to this section. The provisions
ester, polyalkylene glycol alkyl ether of § 721.1725(b)(1) apply to paragraph
(2) Limitations or revocation of alkyl alkenoate and (a)(2)(iii) of this section.
certain notification requirements. The alkylcarbomonocyclic alkenoate, metal
provisions of § 721.185 apply to this salt (PMN P–16–536) is subject to ■ 30. Add § 721.11050 to subpart E to
section. reporting under this section for the read as follows:
(3) Determining whether a specific use significant new uses described in § 721.11050 Certain functionalized
is subject to this section. The provisions paragraph (a)(2) of this section. methacrylate-substituted polymers.
of § 721.1725(b)(1) apply to paragraph (2) The significant new uses are:
(i) Industrial, commercial, and (a)(1) The chemical substances listed
(a)(2)(iii) of this section.
consumer activities. Requirements as in the Table of this section is subject to
■ 29. Add § 721.11049 to subpart E to specified in § 721.80(f) and (k.) It is a reporting under this section for the
read as follows: significant new use to manufacture the significant new uses described in
substance such that the lowest number paragraph (a)(2) of this section. The
average molecular weight is less than requirements of this section do not
1,800 daltons, and the carboxylic acid apply to quantities of the substances
content exceeds 20 percent). 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: (particulate), (b) (concentration set at apply to this section except as modified
(i) Protection in the workplace. 1.0%), and (c). by this paragraph.
Requirements as specified in (ii) Industrial, commercial, and (1) Recordkeeping. Recordkeeping
§ 721.63(a)(1), (a)(2)(i), (iii), (a)(3), when consumer activities. Requirements as requirements as specified in
determining which persons are specified in § 721.80(f) and (k) § 721.125(a) through (e), and (i) are
reasonably likely to be exposed as (crosslinked resin used for applicable to manufacturers and
required for § 721.63(a)(1) engineering chromatographic separation of processors of this substance.
sradovich on DSK3GMQ082PROD with RULES2
control measures (e.g., enclosure or biomolecules and biocatalysts). It is a (2) Limitations or revocation of
confinement of the operation, general significant new use to import the certain notification requirements. The
and local ventilation) or administrative substance in any form other than provisions of § 721.185 apply to this
control measures (e.g., workplace spherical beads with 0.1 percent less section.
policies and procedures) shall be than 10 microns
considered and implemented to prevent ■ 31. Add § 721.11051 to subpart E to
(b) Specific requirements. The
exposure, where feasible, (a)(6) read as follows:
provisions of subpart A of this part
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![37730 Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Rules and Regulations
TABLE—HALOGENATED SODIUM BENZOATE SALTS—Continued
PMN No. CAS No. Chemical name
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: an alternative to § 721.63 respirator (b) Specific requirements. The
(i) Protection in the workplace. requirements may request to do so provisions of subpart A of this part
Requirements as specified in under § 721.30. Persons whose § 721.30 apply to this section except as modified
§ 721.63(a)(1), (2)(i), (iv), (a)(3), when requests to use the NCELs approach are by this paragraph.
determining which persons are approved by EPA will be required to (1) Recordkeeping. Recordkeeping
reasonably likely to be exposed as follow NCELs provisions comparable to requirements as specified in
required for § 721.63(a)(4), engineering those contained in the corresponding § 721.125(a) through (i) and (k) are
control measures (e.g., enclosure or TSCA section 5(e) Order. applicable to manufacturers and
confinement of the operation, general (B) [Reserved]
(ii) Hazard communication. processors of this substance.
and local ventilation) or administrative
control measures (e.g., workplace Requirements as specified in § 721.72(a) (2) Limitations or revocation of
policies and procedures) shall be through (e) (concentration set at 1.0%), certain notification requirements. The
considered and implemented to prevent (f), (g)(1)(i), (ii), (iii), (iv), (vi), (ix), provisions of § 721.185 apply to this
exposure, where feasible, (a)(5) (g)(2)(i), (ii), (iii), (use respiratory section.
(respirators must provide a National protection or maintain workplace (3) Determining whether a specific use
Institute for Occupational Safety and airborne concentrations at or below an is subject to this section. The provisions
Health (NIOSH) assigned protection 8-hour time-weighted average of 0.0184 of § 721.1725(b)(1) apply to paragraph
factor of at least 50), (a)(6) (particulate), mg/m3), (g)(2)(v), and (g)(5). Alternative (a)(2)(iii) of this section.
(a)(6)(v), (vi), (b) (concentration set at hazard and warning statements that
1.0%), and (c). meet the criteria of the Globally ■ 34. Add § 721.11054 to subpart E to
(A) As an alternative to the respirator Harmonized System (GHS) and OSHA read as follows:
requirements in paragraph (a)(2)(i) of Hazard Communication Standard may
§ 721.11054 Certain halogenated benzoic
this section, a manufacturer or processor be used. acids
may choose to follow the new chemical (iii) Industrial, commercial, and
exposure limit (NCEL) provision listed consumer activities. Requirements as (a) The chemical substances listed in
in the TSCA section 5(e) Order for this specified in § 721.80(k), (q) and (t). It is the Table of this section is subject to
substance. The NCEL is 0.0184 mg/m3 a significant new use to manufacture or reporting under this section for the
as an 8-hour time weighted average. process the substances other than for the significant new uses described in
Persons who wish to pursue NCELs as processes described in the Order. 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-.
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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-.
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TABLE—HALOGENATED BENZOIC ACIDS—Continued
PMN No. CAS No. Chemical name
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: an alternative to § 721.63 respirator (b) Specific requirements. The
(i) Protection in the workplace. requirements may request to do so provisions of subpart A of this part
Requirements as specified in under § 721.30. Persons whose § 721.30 apply to this section except as modified
§ 721.63(a)(1), (a)(2)(i), (v), (a)(3), (4), requests to use the NCELs approach are by this paragraph.
when determining which persons are approved by EPA will be required to (1) Recordkeeping. Recordkeeping
reasonably likely to be exposed as follow NCELs provisions comparable to requirements as specified in
required for § 721.63(a)(1) and (4), those contained in the corresponding § 721.125(a) through (i) and (k) are
engineering control measures (e.g., TSCA section 5(e) Order. applicable to manufacturers and
enclosure or confinement of the (B) [Reserved]
(ii) Hazard communication. processors of this substance.
operation, general and local ventilation)
or administrative control measures (e.g., Requirements as specified in § 721.72(a) (2) Limitations or revocation of
workplace policies and procedures) through (e) (concentration set at 1.0%), certain notification requirements. The
shall be considered and implemented to (f), (g)(1)(i), (ii), (iii), (iv), (vi), (ix), provisions of § 721.185 apply to this
prevent exposure, where feasible, (a)(5) (g)(2)(i), (ii), (iii), (use respiratory section.
(respirators must provide a National protection or maintain workplace (3) Determining whether a specific use
Institute for Occupational Safety and airborne concentrations at or below an is subject to this section. The provisions
Health (NIOSH) assigned protection 8-hour time-weighted average of 0.0184 of § 721.1725(b)(1) apply to paragraph
factor of at least 50, (a)(6) (particulate), mg/m3), (g)(2)(v), and (g)(5). Alternative (a)(2)(iii) of this section.
(a)(6)(v), (vi), (b) (concentration set at hazard and warning statements that
1.0%), and (c). meet the criteria of the Globally ■ 35. Add § 721.11055 to subpart E to
(A) As an alternative to the respirator Harmonized System (GHS) and OSHA read as follows:
requirements in paragraph (a)(2)(i) of Hazard Communication Standard may
§ 721.11055 Certain halogenated benzoic
this section, a manufacturer or processor be used. acids ethyl esters.
may choose to follow the new chemical (iii) Industrial, commercial, and
exposure limit (NCEL) provision listed consumer activities. Requirements as (a) The chemical substances listed in
in the TSCA section 5(e) Order for this specified in § 721.80(q) and (t). It is a the Table of this section is subject to
substance. The NCEL is 0.0184 mg/m3 significant new use to manufacture or reporting under this section for the
as an 8-hour time weighted average. process the substances other than for the significant new uses described in
Persons who wish to pursue NCELs as processes described in the Order. 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.
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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.
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![37732 Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Rules and Regulations
TABLE—HALOGENATED BENZOIC ACID ETHYL ESTERS—Continued
PMN No. CAS No. Chemical name
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: specified in § 721.80(q) and (t). It is a through (e) (concentration set 1.0%), (f),
(i) Protection in the workplace. significant new use to manufacture or (g)(1)(ix), (The substance may react
Requirements as specified in process the substances other than for violently with water, (This substance
§ 721.63(a)(1), (a)(2)(i), (v), (a)(3), (4), processes described in the Order. may cause skin irritation and corrosion),
when determining which persons are (iv) Release to water. Requirements as (This substance may cause respiratory
reasonably likely to be exposed as specified in § 721.90(a)(4), (b)(4), and complications, irritation, and corrosion),
required for § 721.63(a)(1) and (4), (c)(4) where N = 15 ppb. (g)(2)(i), (ii), (iii), (When using this
engineering control measures (e.g., (b) Specific requirements. The substance use in closed system to
enclosure or confinement of the provisions of subpart A of this part prevent any inhalation exposure),
operation, general and local ventilation) apply to this section except as modified (When using this substance use skin and
or administrative control measures (e.g., by this paragraph. eye protection), and (g)(5). Alternative
workplace policies and procedures) (1) Recordkeeping. Recordkeeping hazard and warning statements that
shall be considered and implemented to requirements as specified in meet the criteria of the Globally
prevent exposure, where feasible, (a)(5) § 721.125(a) through (i) and (k) are Harmonized System (GHS) and OSHA
(respirators must provide a National applicable to manufacturers and Hazard Communication Standard may
Institute for Occupational Safety and processors of this substance. be used.
Health (NIOSH) assigned protection (2) Limitations or revocation of (iii) Industrial, commercial, and
factor of at least 1000), (a)(6) certain notification requirements. The consumer activities. Requirements as
(particulate), (a)(6)(v), (vi), (b) provisions of § 721.185 apply to this specified in § 721.80(c) (It is a
(concentration set at 1.0%), and (c). section. significant new use to process the
(3) Determining whether a specific use substance in manner that results in
(A) As an alternative to the respirator
is subject to this section. The provisions inhalation exposure.), (f), and (p) (8
requirements in paragraph (a)(2)(i) of
of § 721.1725(b)(1) apply to paragraph months).
this section, a manufacturer or processor
(a)(2)(iii) of this section. (b) Specific requirements. The
may choose to follow the new chemical
exposure limit (NCEL) provision listed ■ 36. Add § 721.11056 to subpart E to provisions of subpart A of this part
in the TSCA section 5(e) Order for this read as follows: apply to this section except as modified
substance. The NCEL is 0.0184 mg/m3 by this paragraph.
§ 721.11056 Neodymium aluminium alkyl (1) Recordkeeping. Recordkeeping
as an 8-hour time weighted average. polymer complexes (generic).
requirements as specified in
Persons who wish to pursue NCELs as (a) Chemical substance and § 721.125(a) through (i) are applicable to
an alternative to § 721.63 respirator significant new uses subject to reporting. manufacturers and processors of this
requirements may request to do so (1) The chemical substance identified substance.
under § 721.30. Persons whose § 721.30 generically as neodymium aluminium (2) Limitations or revocation of
requests to use the NCELs approach are alkyl polymer complexes (PMN P–17– certain notification requirements. The
approved by EPA will be required to 198) is subject to reporting under this provisions of § 721.185 apply to this
follow NCELs provisions comparable to section for the significant new uses section.
those contained in the corresponding described in paragraph (a)(2) of this (3) Determining whether a specific use
TSCA section 5(e) Order. section. is subject to this section. The provisions
(B) [Reserved] (2) The significant new uses are: of § 721.1725(b)(1) apply to paragraph
(ii) Hazard communication. (i) Protection in the workplace. (a)(2)(iii) of this section.
Requirements as specified in § 721.72(a) Requirements as specified in ■ 37. Add § 721.11057 to subpart E to
through (e) (concentration set at 1.0%), § 721.63(a)(1), (a)(2)(i), (ii), (iii), (a)(3), read as follows:
(f), (g)(1)(i), (ii), (iii), (iv), (vi), (ix), when determining which persons are
(g)(2)(i), (ii), (iii), (use respiratory reasonably likely to be exposed as § 721.11057 Fatty acid amide alkyl amine
protection or maintain workplace required for § 721.63(a)(1), engineering salts (generic).
airborne concentrations at or below an control measures (e.g., enclosure or (a) Chemical substance and
8-hour time-weighted average of 0.0184 confinement of the operation, general significant new uses subject to reporting.
mg/m3), (g)(2)(v), (g)(3)(i), (ii), (g)(4)(i), and local ventilation) or administrative (1) The chemical substances identified
sradovich on DSK3GMQ082PROD with RULES2
and (g)(5). Alternative hazard and control measures (e.g., workplace generically as fatty acid amide alkyl
warning statements that meet the policies and procedures) shall be amine salts (PMN P–17–272, P–17–273,
criteria of the Globally Harmonized considered and implemented to prevent P–17–274, P–17–275, P–17–276 and P–
System (GHS) and OSHA Hazard exposure, where feasible, (b) 17–277) are subject to reporting under
Communication Standard may be used. (concentration set 1.0%), and (c). this section for the significant new uses
(iii) Industrial, commercial, and (ii) Hazard communication. described in paragraph (a)(2) of this
consumer activities. Requirements as Requirements as specified in § 721.72(a) section. The requirements of this section
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![Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Rules and Regulations 37733
do not apply to quantities of the § 721.125(a) through (i), and (k) are (ii) Hazard communication.
substances after they have been reacted applicable to manufacturers and Requirements as specified in § 721.72(a)
(cured). processors of this substance. through (e) (concentration set at 1.0%),
(2) The significant new uses are: (2) Limitations or revocation of (f), (g)(1) (skin irritation), (respiratory
(i) Protection in the workplace. certain notification requirements. The complication), (internal organ effect),
Requirements as specified in provisions of § 721.185 apply to this (systemic effect), (sensitization),
§ 721.63(a)(1), (a)(2)(i), (iii), (iv), (a)(3). section. (g)(2)(i), (ii), (iii), (v), (g)(3)(i), (ii),
When determining which persons are (3) Determining whether a specific use (g)(4)(i), (iii), and (g)(5). Alternative
reasonably likely to be exposed as is subject to this section. The provisions
hazard and warning statements that
required for § 721.63(a)(1) engineering of § 721.1725(b)(1) apply to paragraph
meet the criteria of the Globally
control measures (e.g., enclosure or (a)(2)(iii) of this section.
Harmonized System (GHS) and OSHA
confinement of the operation, general ■ 38. Add § 721.11058 to subpart E to
and local ventilation) or administrative Hazard Communication Standard may
read as follows:
control measures (e.g., workplace be used.
policies and procedures) shall be § 721.11058 Fatty acid amide alkyl amine (iii) Industrial, commercial, and
considered and implemented to prevent salts (generic). consumer activities. Requirements as
exposure, where feasible. (a) Chemical substance and specified in § 721.80(k), and (y)(1).
(ii) Hazard communication. significant new uses subject to reporting.
(1) The chemical substances identified (iv) Release to water. Requirements as
Requirements as specified in § 721.72(a)
generically as fatty acid amide alkyl specified in § 721.90(a)(1), (b)(1), and
through (e) (concentration set at 1.0%),
amine salts (PMN P–17–278, P–17–279 (c)(1).
(f), (g)(1) (skin irritation), (respiratory
complication), (internal organ effect), and P–17–280) are subject to reporting (b) Specific requirements. The
(systemic effect), (sensitization), under this section for the significant provisions of subpart A of this part
(g)(2)(i), (ii), (iii), (v), (g)(3)(i), (ii), new uses described in paragraph (a)(2) apply to this section except as modified
(g)(4)(i), (iii), and (g)(5). Alternative of this section. The requirements of this by this paragraph.
hazard and warning statements that section do not apply to quantities of the
(1) Recordkeeping. Recordkeeping
meet the criteria of the Globally substances after they have been reacted
requirements as specified in
Harmonized System (GHS) and OSHA (cured).
(2) The significant new uses are: § 721.125(a) through (i), and (k) are
Hazard Communication Standard may applicable to manufacturers and
be used. (i) Protection in the workplace.
Requirements as specified in processors of this substance.
(iii) Industrial, commercial, and
consumer activities. Requirements as § 721.63(a)(1), (a)(2)(i), (iii), (iv), (a)(3). (2) Limitations or revocation of
specified in § 721.80(k), and (y)(1). When determining which persons are certain notification requirements. The
(iv) Release to water. Requirements as reasonably likely to be exposed as provisions of § 721.185 apply to this
specified in § 721.90(a)(1), (b)(1), and required for § 721.63(a)(1) engineering section.
(c)(1). control measures (e.g., enclosure or
(3) Determining whether a specific use
(b) Specific requirements. The confinement of the operation, general
and local ventilation) or administrative is subject to this section. The provisions
provisions of subpart A of this part
control measures (e.g., workplace of § 721.1725(b)(1) apply to paragraph
apply to this section except as modified
policies and procedures) shall be (a)(2)(iii) of this section.
by this paragraph.
(1) Recordkeeping. Recordkeeping considered and implemented to prevent [FR Doc. 2018–15995 Filed 7–31–18; 8:45 am]
requirements as specified in exposure, where feasible. BILLING CODE 6560–50–P
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Document Created: 2018-08-01 01:22:40
Document Modified: 2018-08-01 01:22:40
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Direct final rule. | |
| Dates | This rule is effective on October 1, 2018. For purposes of judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on August 15, 2018. | |
| Contact | For technical information contact: Kenneth Moss, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, | |
| FR Citation | 83 FR 37702 | |
| RIN Number | 2070-AB27 | |
| CFR Citation | 40
CFR
721 40 CFR 9 | |
| CFR Associated | Chemicals; Hazardous Substances; Environmental Protection and Reporting and Recordkeeping Requirements |
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