83 FR 43527 - Significant New Use Rules on Certain Chemical Substances
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 83, Issue 166 (August 27, 2018)
Federal Register Volume 83, Issue 166 (August 27, 2018)
| Page Range | 43527-43538 | |
| FR Document | 2018-18534 |
[Federal Register Volume 83, Number 166 (Monday, August 27, 2018)] [Rules and Regulations] [Pages 43527-43538] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-18534] ======================================================================= ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 9 and 721 [EPA-HQ-OPPT-2017-0560; FRL-9982-77] 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 10 chemical substances which were the subject of premanufacture notices (PMNs). The chemical substances are subject to Orders issued by EPA pursuant to section 5(e) of TSCA. This action requires persons who intend to manufacture (defined by statute to include import) or process any of these 10 chemical substances for an activity that is designated as a significant new use by this rule to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA's evaluation of the intended use within the applicable review period. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required with that determination. DATES: This rule is effective on October 26, 2018. For purposes of judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on September 10, 2018. Written adverse comments on one or more of these SNURs must be received on or before September 26, 2018 (see Unit VI. of the SUPPLEMENTARY INFORMATION). If EPA receives written adverse commentsts, on one or more of these SNURs before September 26, 2018, EPA will withdraw the relevant sections of this direct final rule before its effective date. For additional information on related reporting requirement dates, see Units I.A., VI., and VII. of the SUPPLEMENTARY INFORMATION. ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2017-0560, 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) [[Page 43528]] or other information whose disclosure is restricted by statute. Mail: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001. Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: For technical information contact: Kenneth Moss, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 564-9232; email address: [email protected]. For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address: [email protected]. SUPPLEMENTARY INFORMATION: I. General Information A. Does this action apply to me? You may be potentially affected by this action if you manufacture, process, or use the chemical substances contained in this rule. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include: Manufacturers or processors of one or more subject chemical substances (NAICS codes 325 and 324110), e.g., chemical manufacturing and petroleum refineries. This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements promulgated at 19 CFR 12.118 through 12.127 and 19 CFR 127.28. Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA. Importers of chemicals subject to these SNURs must certify their compliance with the SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export a chemical substance that is the subject of this rule on or after September 26, 2018 are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see Sec. 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D. B. What should I consider as I prepare my comments for EPA? 1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. 2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html. II. Background A. What action is the Agency taking? 1. Direct Final Rule. EPA is promulgating these SNURs using direct final rule procedures. These SNURs will require persons to notify EPA at least 90 days before commencing the manufacture or processing of a chemical substance for any activity designated by these SNURs as a significant new use. Receipt of such notices obligates EPA to assess risks that may be associated with the significant new uses under the conditions of use and, if appropriate, to regulate the proposed uses before they occur. 2. Proposed Rule. In addition to this direct final rule, elsewhere in this issue of the Federal Register, EPA is issuing a notice of proposed rulemaking for this rule. If EPA receives no adverse comment, the Agency will not take further action on the proposed rule and the direct final rule will become effective as provided in this action. If EPA receives adverse comment on one or more of SNURs in this action by September 11, 2018 (see Unit VI. of the SUPPLEMENTARY INFORMATION), the Agency will publish in the Federal Register a timely withdrawal of the specific SNURs that the adverse comments pertain to, informing the public that the actions will not take effect. EPA would then address all adverse public comments in a response to comments document in a subsequent final rule, based on the proposed rule. B. What is the Agency's authority for taking this action? Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a ``significant new use.'' EPA must make this determination by rule after considering all relevant factors, including the four bulleted TSCA section 5(a)(2) factors listed in Unit III. Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1)(B) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture or process the chemical substance for that use (15 U.S.C. 2604(a)(1)(B)(i)). TSCA furthermore prohibits such manufacturing or processing from commencing until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required in association with that determination (15 U.S.C. 2604(a)(1)(B)(ii)). As described in Unit V., the general SNUR provisions are found at 40 CFR part 721, subpart A. C. Applicability of General Provisions General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the rule. Provisions relating to user fees appear at 40 CFR part 700. According to Sec. 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 [[Page 43529]] 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 10 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 10 chemical substances in 40 CFR part 721, subpart E. In this unit, EPA provides the following information for each chemical substance: PMN number. Chemical name (generic name, if the specific name is claimed as CBI). Chemical Abstracts Service (CAS) Registry number (if assigned for non-confidential chemical identities). Basis for the TSCA section 5(e) Order. Information identified by EPA that would help characterize the potential health and/or environmental effects of the chemical substance in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use designated by the SNUR. This information may include testing required in a TSCA section 5(e) Order to be conducted by the PMN submitter, as well as testing not required to be conducted but which would also help characterize the potential health and/or environmental effects of the PMN substance. Any recommendation for information identified by EPA was made based on EPA's consideration of available screening-level data, if any, as well as other available information on appropriate testing for the chemical substance. Further, any such testing identified by EPA that includes testing on vertebrates was made after consideration of available toxicity information, computational toxicology and bioinformatics, and high-throughput screening methods and their prediction models. EPA also recognizes that whether testing/further information is needed will depend on the specific exposure and use scenario in the SNUN. EPA encourages all SNUN submitters to contact EPA to discuss any potential future testing. See Unit VIII. for more information. CFR citation assigned in the regulatory text section of this rule. The regulatory text sections of these rules specify the activities designated as significant new uses. Certain new uses, including exceedance of production volume limits (i.e., limits on manufacture volume) and other uses designated in this rule, may be claimed as CBI. Unit IX. discusses a procedure companies may use to ascertain whether a proposed use constitutes a significant new use. These rules include 10 PMN substances that are subject to Orders under TSCA section 5(e)(1)(A). Each Order is based on one or more of the findings in TSCA section 5(a)(3)(B): There is insufficient information to permit a reasoned evaluation; in the absence of sufficient information to permit a reasoned evaluation, the activities associated with the PMN substances may present unreasonable risk to human health or the environment; the substance is or will be produced in substantial quantities, and enters or may reasonably be anticipated to enter the environment in substantial quantities or there is or may be significant (substantial) human exposure to the substance. 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 determines that the PMN substance may present an unreasonable risk of injury to human health via inhalation exposure, the underlying TSCA section 5(e) Order requires, among other things, that potentially exposed employees wear specified respirators unless actual measurements of the workplace air show that air-borne concentrations of the PMN substance are below a New Chemical Exposure Limit (NCEL) that is established by EPA to provide adequate protection to human health. In addition to the actual NCEL concentration, the comprehensive NCELs provisions in TSCA section 5(e) Orders, which are modeled after Occupational Safety and Health Administration (OSHA) Permissible Exposure Limits (PELs) provisions, include requirements addressing performance criteria for sampling and analytical methods, periodic monitoring, respiratory protection, and recordkeeping. However, no comparable NCEL provisions currently exist in 40 CFR part 721, subpart B, for SNURs. Therefore, for these cases, the individual SNURs in 40 CFR part 721, subpart E, will state that persons subject to the SNUR who wish to pursue NCELs as an alternative to the Sec. 721.63 respirator requirements may request to do so under Sec. 721.30. EPA expects that persons whose Sec. 721.30 requests to use the NCELs approach for SNURs that are approved by EPA will be required to comply with NCELs provisions that are comparable to those contained in the corresponding TSCA section 5(e) Order for the same chemical substance. PMN Number: P-13-307 Chemical name: Substituted carbocycle, N-[[[4-[[(4-substituted carbocyclic)amino]sulfonyl]carbocyclic]amino]carbonyl]-4-methyl- (generic). CAS number: Not available. Effective date of TSCA section 5(e) Order: July 31, 2017. Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the substance will be as a component of manufactured consumer article--contained use. Based on SAR analysis of test data on analogous substances, EPA has identified concerns for systemic toxicity on the spleen, liver and thymus, blood effects, developmental toxicity and immunotoxicity. Based on SAR analysis for amides, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 5 parts per billion (ppb) in surface waters. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to [[Page 43530]] health and the environment. To protect against these risks, the Order requires: 1. Submission of certain toxicity testing prior to exceeding the confidential production volume limit specified in the Order; 2. Use of personal protective equipment, including impervious gloves, to prevent dermal exposure; 3. Use of NIOSH certified respirators with Assigned Protection Factor (APF) of 10 to prevent inhalation exposures or compliance with a NCEL of 4 mg/m\3\ as an 8-hour time-weighted average to prevent inhalation exposure; 4. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the Safety Data Sheet (SDS); 5. Refraining from manufacturing the PMN substance in the United States (i.e., import only); 6. Use of the PMN substance only for the confidential use specified in the Order; and 7. No release of the PMN substances resulting in surface water concentrations that exceed 30 ppb. The SNUR designates as a ``significant new use'' the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the 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 a certain production volume limit without performing specific organ toxicity testing. CFR citation: 40 CFR 721.11116. PMN Numbers: P-16-316 and P-16-317 Chemical name: Aliphatic polyester (generic). CAS numbers: Not available. Effective date of TSCA section 5(e) Order: July 27, 2017. Basis for TSCA section 5(e) Order: The PMNs state that the generic (non-confidential) use of the substances will be as drilling chemicals. Based on SAR analysis of test data on analogous substances, EPA has identified concerns for kidney toxicity. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substances may present an unreasonable risk of injury to health and the environment. To protect against these risks, the Order requires: 1. Use of the PMN substances only for the confidential use specified in the Order; and 2. Manufacture (which under TSCA includes import) the PMN substances with a average molecular weight no lower than 22,000 for P- 16-0316 and no lower than 14,000 for P-16-0317 and species with a molecular weight less than 500 present at a maximum of 2% by weight. The SNUR designates as a ``significant new use'' the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the fate, environmental toxicity 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. EPA has determined that the results of water solubility and log Kow testing, acute and chronic aquatic toxicity testing and developmental 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 will remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information. CFR citations: 40 CFR 721.11117. PMN Number: P-16-342 Chemical name: Modified acrylic polymer (generic). CAS number: Not available. Effective date of TSCA section 5(e) Order: August 7, 2017. Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the substance will be as a dispersant for deflocculation of pigments in industrial paints and coatings. Based on SAR analysis of test data on analogous substances, EPA has identified concerns for lung toxicity. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to health and the environment. To protect against these risks, the Order requires: 1. Refrain from manufacturing the PMN substance in the United States (i.e., import only); 2. Use of the PMN substance only as a dispersant for deflocculation of pigments in industrial paints and coatings; 3. Use the PMN substance in the paint/coating formulation at a concentration not greater than 1 percent by weight or volume; 4. No modification of the processing method or use activities of the PMN substance that would allow inhalation exposure to the PMN substance by vapor, dust, mist or aerosols at concentrations greater than 1 percent by weight or volume; and 5. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the (SDS). The SNUR designates as a ``significant new use'' the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the 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. EPA has determined that the results of pulmonary toxicity testing 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 will remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information. CFR citation: 40 CFR 721.11118. PMN Numbers: P-16-406 and P-16-407 Chemical names: Functionalized polyimide (generic). CAS numbers: Not available. Effective date of TSCA section 5(e) Order: July 27, 2017. Basis for TSCA section 5(e) Order: The PMNs state that the generic (non-confidential) use of the substances will be as coating for solid substrates. Based on SAR analysis of test data on analogous substances, EPA has identified concerns for lung toxicity. The Order was issued under TSCA sections 5(a)(3)(B)(i) and 5(e)(1)(A)(i), based on a finding that the information available to the Agency is insufficient to permit a reasoned evaluation of the human health effects. To protect against any potential risks the Order requires: 1. Use of the PMN substances only as a coating for solid substrates; 2. No use of the PMN substances involving application methods that [[Page 43531]] generate inhalation exposures to the PMN substance by vapor, dust, mist or aerosols; and 3. No modification of manufacturing process of the PMN substances such that workers would be exposed through inhalation. The SNUR designates as a ``significant new use'' the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the 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. EPA has determined that the results of pulmonary toxicity testing may be potentially useful in characterizing the health effects of the PMN substances. Although the Order does not require these tests, the Order's restrictions will remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information. CFR citation: 40 CFR 721.11119. PMN Number: P-16-413 Chemical name: Siloxanes and Silicones, di-Me, 3-hydroxypropyl Me, Me 3,3,4,4,5,5,6,6,6-nonafluorohexyl. CAS number: 1610862-54-8. Effective date of TSCA section 5(e) Order: July 13, 2017. Basis for TSCA section 5(e) Order: The PMN states that the use of the PMN substance is as an anti-fingerprint material for a metal coating application. Based on SAR analysis of test data on analogous substances, EPA has identified concerns for lung toxicity based on waterproofing of the lung if inhaled. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to health and the environment. To protect against these risks, the Order requires: 1. Submission of certain fate testing on the PMN substance prior to exceeding the production volume limits specified in the Order; 2. No processing or use of the PMN substance in a manner that results in inhalation exposure due to spray, mist or aerosol; 3. Refraining from manufacturing the PMN substance in the United States (i.e., import only); and 4. No release of the PMN substance into the waters of the United States. The SNUR designates as a ``significant new use'' the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the fate and 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 a UV/visible absorption test, a direct and indirect photolysis test, aerobic and anaerobic transformation in soil test and aerobic and anaerobic transformation in sediment test. In addition, EPA has determined that the results of pulmonary toxicity testing may be potentially useful in characterizing the human health effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions will remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information. CFR citation: 40 CFR 721.11120. PMN Number: P-16-455 Chemical name: Sodium Tungsten Oxide. CAS number: 11120-01-7. Effective date of TSCA section 5(e) Order: November 2, 2016. Basis for TSCA section 5(e) Order: The PMN states that the use of the PMN substance will be as a component of infrared absorption material. Based on test data on an analog, EPA has identified concerns for lung toxicity and carcinogenicity. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to health and the environment. EPA assessed risks based on the disposal processes and engineering controls 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 specified in the Order; 2. Use of personal protective equipment, including impervious gloves, to prevent dermal exposure; 3. Use of NIOSH certified respirators with a minimum (APF) of 1000 to prevent inhalation exposure or compliance with a NCEL of 0.3 mg/m\3\ as an 8-hour time-weighted average to prevent inhalation exposure; 4. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the (SDS); 5. Use of the PMN substance only as a component of infrared absorption material; 6. No use of the PMN substance involving application methods that generate dust, mist or aerosol unless such application method occurs within an enclosed process; 7. No release of the PMN substance into the waters of the United States; and 8. The PMN substance and any waste streams from manufacture, processing, and use containing the PMN substance must be disposed of only by incineration or landfill. The SNUR designates as a ``significant new use'' the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the human health and environmental toxicity of the PMN substance may be potentially useful to characterize the effects of the PMN substance in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. The submitter has agreed not to exceed the confidential production limit without performing specific pulmonary toxicity and carcinogenicity testing. In addition, EPA has determined that the results of certain chronic aquatic toxicity testing may be potentially useful in characterizing the environmental effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions will remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information. CFR citation: 40 CFR 721.11121. PMN Number: P-16-503 Chemical name: Fatty acids, tall-oil, polymers with alkanoic acid, substituted carbomonocycle, alkyl peroxide-initiated (generic). CAS number: Not available. Effective date of TSCA section 5(e) Order: January 11, 2017. Basis for TSCA section 5(e) Order: The PMN states that the non- confidential use of the PMN substance will be as a site-limited polymer intermediate for production of a deck stain coating resin additive. Based on physical-chemical properties of the PMN substance, EPA identified low [[Page 43532]] concerns for human health and environmental effects. However if the PMN substance were manufactured differently, EPA identified concerns for developmental toxicity and aquatic toxicity. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to health and the environment. To protect against these risks, the Order requires: 1. Manufacture (including import) the PMN substance with a number average molecular weight no lower than 1500, and no more than 24% by weight of acid monomer in the polymer; and 2. Use of the PMN substance only as an intermediate The SNUR designates as a ``significant new use'' the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the fate, human health and environmental toxicity of the PMN substance may be potentially useful to characterize the effects of the PMN substance in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of physical-chemical property testing, chronic aquatic toxicity testing, and developmental toxicity testing may be potentially useful in characterizing the health and environmental effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions will remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information. CFR citation: 40 CFR 721.11122. PMN Number: P-16-570 Chemical name: Carboxylic acids, C6-18 and C8-15-di, polymers with diethylene glycol, glycerol, oleic acid, phthalic acid and sorbitol. CAS number: 1877295-51-6. Effective date of TSCA section 5(e) Order: August 5, 2017. Basis for TSCA section 5(e) Order: The PMN states that the use of the PMN substance will be as an aromatic polyester polyol for manufacturing rigid foam. Based on test data on an analog, EPA has identified concerns for reproductive and developmental toxicity. Based on SAR analysis for esters, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 610 parts per billion (ppb). The Order was issued under TSCA sections 5(a)(3)(B)(i) and 5(e)(1)(A)(i), based on a determination that ``the information available is insufficient to permit a reasoned evaluation of the human health effects and the PMN substance, ``stating that ``because of the absence of sufficient information to permit EPA to make such a determination and in light of the potential risk of human health effects posed by the uncontrolled manufacture (which includes import), processing, distribution in commerce, use and disposal of the PMN substance. EPA has concluded that uncontrolled manufacture, processing, distribution in commerce use, and disposal of the PMN 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 prior to exceeding the confidential production volume limit specified in the Order; 2. Use of personal protective equipment to prevent dermal exposures; 3. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the (SDS); 4. Manufacture (including import) the PMN substance with residual phthalate not greater than 0.1% by weight; 5. Use of the PMN substance only as an aromatic polyester polyol for rigid foam; 6. No modification of manufacturing, processing or use activities of the PMN substance to result in the generation of a vapor, mist or aerosol; and 7. No release of the PMN substance into the waters of the United States. The SNUR designates as a ``significant new use'' the absence of these protective measures. Potentially useful information: EPA has determined that certain information about the environmental and 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 reproductive/developmental toxicity testing. In addition, EPA has determined that the results of acute aquatic toxicity testing may be potentially useful in characterizing the environmental effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions will remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information. CFR citation: 40 CFR 721.11123. 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 10 chemical substances, regulation was warranted under TSCA section 5(e), pending the development of information sufficient to make reasoned evaluations of the health or environmental effects of the chemical substances. The basis for such findings is outlined in Unit IV. Based on these findings, TSCA section 5(e) Orders requiring the use of appropriate exposure controls were negotiated with the PMN submitters. The SNURs identify as significant new uses any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the restrictions imposed by the underlying Orders, consistent with TSCA section 5(f)(4). B. Objectives EPA is issuing these SNURs for specific chemical substances which have undergone premanufacture review because the Agency wants to achieve the following objectives with regard to the significant new uses designated in this rule: EPA will receive notice of any person's intent to manufacture or process a listed chemical substance for the described significant new use before that activity begins. EPA will have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing or processing a listed chemical substance for the described significant new use. EPA will be able to either determine that the prospective manufacture or processing is not likely to present an unreasonable risk, or to take necessary regulatory action associated with any other determination, before the described significant new use of the chemical substance occurs. EPA will identify as significant new uses any manufacturing, processing, distribution in commerce, use, or disposal that does not conform to the restrictions imposed by the underlying Orders, consistent with TSCA section 5(f)(4). Issuance of a SNUR for a chemical substance does not signify that the chemical substance is listed on the [[Page 43533]] TSCA Chemical Substance Inventory (TSCA Inventory). Guidance on how to determine if a chemical substance is on the TSCA Inventory is available on the internet at http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html. VI. Direct Final Procedures EPA is issuing these SNURs as a direct final rule. The effective date of this rule is October 26, 2018 without further notice, unless EPA receives written adverse comments before September 26, 2018. If EPA receives written adverse comments on one or more of these SNURs before September 26, 2018, EPA will withdraw the relevant sections of this direct final rule before its effective date. This rule establishes SNURs for a number of chemical substances. Any person who submits adverse comments must identify the chemical substance and the new use to which it applies. EPA will not withdraw a SNUR for a chemical substance not identified in the comment. VII. Applicability of the Significant New Use Designation To establish a significant new use, EPA must determine that the use is not ongoing. The chemical substances subject to this rule have undergone premanufacture review. In cases where EPA has not received a notice of commencement (NOC) and the chemical substance has not been added to the TSCA Inventory, no person may commence such activities without first submitting a PMN. Therefore, for chemical substances for which an NOC has not been submitted EPA concludes that the designated significant new uses are not ongoing. When chemical substances identified in this rule are added to the TSCA Inventory, EPA recognizes that, before the rule is effective, other persons might engage in a use that has been identified as a significant new use. However, TSCA section 5(e) Orders have been issued for all of the chemical substances, and the PMN submitters are prohibited by the TSCA section 5(e) Orders from undertaking activities which will be designated as significant new uses. The identities of 7 of the 10 chemical substances subject to this rule have been claimed as confidential and EPA has received no post-PMN bona fide submissions (per Sec. Sec. 720.25 and 721.11) for a chemical substance covered by this action. Based on this, the Agency believes that it is highly unlikely that any of the significant new uses described in the regulatory text of this rule are ongoing. Therefore, EPA designates August 27, 2018 as the cutoff date for determining whether the new use is ongoing. The objective of EPA's approach has been to ensure that a person could not defeat a SNUR by initiating a significant new use before the effective date of the direct final rule. Persons who begin commercial manufacture or processing of the chemical substances for a significant new use identified as of that date will have to cease any such activity upon the effective date of the final rule. To resume their activities, these persons will have to first comply with all applicable SNUR notification requirements and wait until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required with that determination. VIII. Development and Submission of Information EPA recognizes that TSCA section 5 does not require developing any particular new information (e.g., generating test data) before submission of a SNUN. There is an exception: development of test data is required where the chemical substance subject to the SNUR is also subject to a rule, order or consent agreement under TSCA section 4 (see TSCA section 5(b)(1)). In the absence of a TSCA section 4 test rule covering the chemical substance, persons are required only to submit information in their possession or control and to describe any other information known to or reasonably ascertainable by them (see 40 CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. Unit IV. lists required or recommended testing for all of the listed SNURs. Descriptions of this information are provided for informational purposes. EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol selection. Furthermore, pursuant to TSCA section 4(h), which pertains to reduction of testing in vertebrate animals, EPA encourages consultation with the Agency on the use of alternative test methods and strategies (also called New Approach Methodologies, or NAMs), if available, to generate the recommended test data. EPA encourages dialog with Agency representatives to help determine how best the submitter can meet both the data needs and the objective of TSCA section 4(h). To access the OCSPP test guidelines referenced in this document electronically, please go to http://www.epa.gov/ocspp and select ``Test Methods and Guidelines.'' The Organisation for Economic Co-operation and Development (OECD) test guidelines are available from the OECD Bookshop at http://www.oecdbookshop.org or SourceOECD at http://www.sourceoecd.org. In certain of the TSCA section 5(e) Orders for the chemical substances regulated under this rule, EPA has established production volume limits in view of the lack of data on the potential health and environmental risks that may be posed by the significant new uses or increased exposure to the chemical substances. These limits cannot be exceeded unless the PMN submitter first submits the results of toxicity tests that would permit a reasoned evaluation of the potential risks posed by these chemical substances. Under recent TSCA section 5(e) Orders, each PMN submitter is required to submit each study at least 14 weeks (earlier TSCA section 5(e) Orders required submissions at least 12 weeks) before reaching the specified production limit. Listings of the tests specified in the TSCA section 5(e) Orders are included in Unit IV. The SNURs contain the same production volume limits as the TSCA section 5(e) Orders. Exceeding these production limits is defined as a significant new use. Persons who intend to exceed the production limit must notify the Agency by submitting a SNUN at least 90 days in advance of commencement of non-exempt commercial manufacture or processing. Any request by EPA for the triggered and pended testing described in the Orders was made based on EPA's consideration of available screening-level data, if any, as well as other available information on appropriate testing for the PMN substances. Further, any such testing request on the part of EPA that includes testing on vertebrates was made after consideration of available toxicity information, computational toxicology and bioinformatics, and high-throughput screening methods and their prediction models. The potentially useful information identified in Unit IV. may not be the only means of addressing the potential risks of the chemical substance. However, submitting a SNUN without any test data 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 [[Page 43534]] 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. 721.1725(b)(1) with that under Sec. 721.11 into a single step. If EPA determines that the use identified in the bona fide submission would not be a significant new use, i.e., the use does not meet the criteria specified in the rule for a significant new use, that person can manufacture or process the chemical substance so long as the significant new use trigger is not met. In the case of a production volume trigger, this means that the aggregate annual production volume does not exceed that identified in the bona fide submission to EPA. Because of confidentiality concerns, EPA does not typically disclose the actual production volume that constitutes the use trigger. Thus, if the person later intends to exceed that volume, a new bona fide submission would be necessary to determine whether that higher volume would be a significant new use. X. SNUN Submissions According to Sec. 721.1(c), persons submitting a SNUN must comply with the same notification requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in 40 CFR 720.50. SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in 40 CFR 720.40 and 721.25. E-PMN software is available electronically at http://www.epa.gov/opptintr/newchems. XI. Economic Analysis EPA has evaluated the potential costs of establishing SNUN requirements for potential manufacturers and processors 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-2017-0560. XII. Statutory and Executive Order Reviews A. Executive Order 12866 This action establishes SNURs for several new chemical substances that were the subject of PMNs and TSCA section 5(e) Orders. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled ``Regulatory Planning and Review'' (58 FR 51735, October 4, 1993). B. Paperwork Reduction Act (PRA) According to PRA (44 U.S.C. 3501 et seq.), an agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR part 9, and included on the related collection instrument or form, if applicable. EPA is amending the table in 40 CFR part 9 to list the OMB approval number for the information collection requirements contained in this action. This listing of the OMB control numbers and their subsequent codification in the CFR satisfies the display requirements of PRA and OMB's implementing regulations at 5 CFR part 1320. This Information Collection Request (ICR) was previously subject to public notice and comment prior to OMB approval, and given the technical nature of the table, EPA finds that further notice and comment to amend it is unnecessary. As a result, EPA finds that there is ``good cause'' under section 553(b)(3)(B) of the Administrative Procedure Act (5 U.S.C. 553(b)(3)(B)) to amend this table without further notice and comment. The information collection requirements related to this action have already been approved by OMB pursuant to PRA under OMB control number 2070-0012 (EPA ICR No. 574). This action does not impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average between 30 and 170 hours per response. This burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete, review, and submit the required SNUN. Send any comments about the accuracy of the burden estimate, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques, to the Director, Collection Strategies Division, Office of Environmental Information (2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001. Please remember to include the OMB control number in any correspondence, but do not submit any completed forms to this address. C. Regulatory Flexibility Act (RFA) On February 18, 2012, EPA certified pursuant to RFA section 605(b) (5 U.S.C. 601 et seq.), that promulgation of a SNUR does not have a significant economic impact on a substantial number of small entities where the following are true: 1. A significant number of SNUNs would not be submitted by small entities in response to the SNUR. 2. The SNUR submitted by any small entity would not cost significantly more than $8,300. A copy of that certification is available in the docket for this action. This action is within the scope of the February 18, 2012 certification. Based on the Economic Analysis discussed in Unit XI. and EPA's experience promulgating SNURs (discussed in the certification), EPA believes that the following are true: A significant number of SNUNs would not be submitted by small entities in response to the SNUR. [[Page 43535]] Submission of the SNUN would not cost any small entity significantly more than $8,300. Therefore, the promulgation of the SNUR would not have a significant economic impact on a substantial number of small entities. D. Unfunded Mandates Reform Act (UMRA) Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or Tribal government will be impacted by this action. As such, EPA has determined that this action does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.). E. Executive Order 13132 This action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 10, 1999). F. Executive Order 13175 This action does not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This action does not significantly nor uniquely affect the communities of Indian Tribal governments, nor does it involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175, entitled ``Consultation and Coordination with Indian Tribal Governments'' (65 FR 67249, November 9, 2000), do not apply to this action. G. Executive Order 13045 This action is not subject to Executive Order 13045, entitled ``Protection of Children from Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997), because this is not an economically significant regulatory action as defined by Executive Order 12866, and this action does not address environmental health or safety risks disproportionately affecting children. H. Executive Order 13211 This action is not subject to Executive Order 13211, entitled ``Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001), because this action is not expected to affect energy supply, distribution, or use and because this action is not a significant regulatory action under Executive Order 12866. I. National Technology Transfer and Advancement Act (NTTAA) In addition, since this action does not involve any technical standards, NTTAA section 12(d) (15 U.S.C. 272 note), does not apply to this action. J. Executive Order 12898 This action does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898, entitled ``Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations'' (59 FR 7629, February 16, 1994). XIII. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a ``major rule'' as defined by 5 U.S.C. 804(2). List of Subjects 40 CFR Part 9 Environmental protection, Reporting and recordkeeping requirements. 40 CFR Part 721 Environmental protection, Chemicals, Hazardous substances, Reporting and recordkeeping requirements. Dated: August 20, 2018. Jeffery T. Morris, Director, Office of Pollution Prevention and Toxics. Therefore, 40 CFR parts 9 and 721 are amended as follows: PART 9--[AMENDED] 0 1. The authority citation for part 9 continues to read as follows: Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003, 2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330, 1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2, 300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542, 9601-9657, 11023, 11048. 0 2. In Sec. 9.1, add the following sections in numerical order under the undesignated center heading ``Significant New Uses of Chemical Substances'' to read as follows: Sec. 9.1 OMB approvals under the Paperwork Reduction Act. * * * * * ------------------------------------------------------------------------ OMB control 40 CFR citation No. ------------------------------------------------------------------------ * * * * * ------------------------------------------------------------------------ Significant New Uses of Chemical Substances ------------------------------------------------------------------------ * * * * * 721.11116............................................... 2070-0012 721.11117............................................... 2070-0012 721.11118............................................... 2070-0012 721.11119............................................... 2070-0012 721.11120............................................... 2070-0012 721.11121............................................... 2070-0012 721.11122............................................... 2070-0012 721.11123............................................... 2070-0012 * * * * * ------------------------------------------------------------------------ * * * * * PART 721--[AMENDED] 0 3. The authority citation for part 721 continues to read as follows: Authority: 15 U.S.C. 2604, 2607, and 2625(c). 0 4. Add Sec. 721.11116 to subpart E to read as follows: Sec. 721.11116 Substituted carbocycle, N-[[[4-[[(4-substituted carbocyclic)amino]sulfonyl]carbocyclic]amino]carbonyl]-4-methyl- (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as substituted carbocycle, N-[[[4-[[(4-substituted carbocyclic)amino]sulfonyl]carbocyclic]amino]carbonyl]-4-methyl- (PMN P-13-307) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(2)(i), (a)(3), (a)(4) (when determining which persons are reasonably likely to be exposed as required for Sec. 721.63(a)(1) and (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 [[Page 43536]] prevent exposure, where feasible), (a)(5)(respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor of at least 10 or maintain workplace airborne concentrations), (a)(6)(particulate), (b)(concentrations 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 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 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), (b), (c), (d), (e)(concentration set at 1.0%), (f), (g)(1)(iv), (viii), (ix), (g)(2)(ii), (iii), (use respiratory protection or maintain workplace airborne concentrations below an 8- hour time-weighted average of 4 mg/m\3\), (g)(2)(v), (g)(4)(i), (ii) and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System (GHS) and OSHA Hazard Communication Standard may be used. (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(f), (k) and (q). (iv) Release to water. Requirements as specified in Sec. 721.90(a)(4), (b)(4), and (c)(4) where N = 30 ppb. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (i) and (k). (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. 721.11117 to subpart E to read as follows: Sec. 721.11117 Aliphatic polyester (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as aliphatic polyester (PMNs P-16-316 and P-16-317) 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) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(k). It is a significant new use to manufacture the PMN substances with an average molecular weight lower than 22,000 daltons for P16-316 and lower than 14,000 daltons for P-16- 317 and containing more than 2% by weight of molecular weight species less than 500 daltons. (ii) [Reserved] (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (c) and (i) are applicable to manufacturers and processors of these substances. (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 6. Add Sec. 721.11118 to subpart E to read as follows: Sec. 721.11118 Modified acrylic polymer (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as modified acrylic polymer (PMN P-16-342) 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), (b), (c), (d), (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(f). It is a significant new use for any use other than as a dispersant for deflocculation of pigments in industrial paints and coatings, any use in the paint/coating formulation at concentration greater than 1 percent by weight or volume, and any use of the substance that would allow inhalation exposure to the substance by vapor, dust, mist or aerosols at concentrations greater than 1 percent by weight or volume. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a), (b), (c), (f), (g), (h), 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 7. Add Sec. 721.11119 to subpart E to read as follows: Sec. 721.11119 Functionalized polyimide (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified as functionalized polyimide (PMN P-16-406 and P-16-407) 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) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(y)(1) and (2). It is a significant new use to use the substances other than as a coating for solid substrates. Any manufacturing process that results in inhalation exposure to the substances is a significant new use. (ii) [Reserved] (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (c) and (i) are applicable to manufacturers and processors of these substances. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 8. Add Sec. 721.11120 to subpart E to read as follows: Sec. 721.11120 Siloxanes and Silicones, di-Me, 3-hydroxypropyl Me, Me 3,3,4,4,5,5,6,6,6-nonafluorohexyl. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as siloxanes and silicones, di-Me, 3-hydroxypropyl Me, Me 3,3,4,4,5,5,6,6,6- nonafluorohexyl (CAS: 1610862-54-8) (PMN P-16-413) 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: [[Page 43537]] (i) Industrial, commercial, and consumer activities. Requirements are described in Sec. 721.80(f) and (p)(40,000 kilograms and 151,300 kilograms). It is a significant new use to process or use the PMN substance in a manner that results in inhalation exposure to spray, mist or aerosol. (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 (b). (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. 0 9. Add Sec. 721.11121 to subpart E to read as follows: Sec. 721.11121 Sodium tungsten oxide. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as sodium tungsten oxide (CAS No. 11120-01-7) (PMN P-16-455) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the PMN substance after they have been incorporated into a polymer matrix. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(2)(i), (a)(3), (a)(4)(when determining which persons are reasonably likely to be exposed as required for Sec. 721.63(a)(1) and (4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible), (a)(5)(respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor of at least 1000, (a)(6)(particulate), (b)(concentrations 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 0.3 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), (b), (c), (d), (e)(concentration set at 0.1%), (f), (g)(1)(lung effects), (g)(1)(vii), (g)(2)(ii), (iii), (g)(2)(use respiratory protection or maintain workplace airborne concentrations below an 8-hour time-weighted average of 0.3 mg/m\3\), (g)(3)(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(q). It is a significant new to use the substance other than as a component of infrared absorption material. It is a significant new use to use involving an application method that generates a dust, mist, or aerosol, unless the application method occurs within an enclosed process. (iv) Disposal. Requirements as specified in Sec. 721.85(a)(1), (2), (b)(1), (2), (c)(1), and (2). (v) Release to water. Requirements as specific in Sec. 721.90(a)(1), (b)(1), and (c)(1). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (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 10. Add Sec. [emsp14]721.11122 to subpart E to read as follows: Sec. [emsp14]721.11122 Fatty acids, tall-oil, polymers with alkanoic acid, substituted carbomonocycle, alkyl peroxide-initiated (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as fatty acids, tall-oil, polymers with alkanoic acid, substituted carbomonocycle, alkyl peroxide-initiated (PMN P-16-503) 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(g). It is a significant new use to manufacture the substance with an average molecular weight lower than 1,500 dalton or more than 24% by weight of acid monomer in the polymer. (ii) [Reserved] (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (c) and (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 11. Add Sec. [emsp14]721.11123 to subpart E to read as follows: Sec. [emsp14]721.11123 Carboxilic acids, C6-18 and C8-15-di, polymers with diethylene glycol, glycerol, oleic acid, phthalic, acid and sorbitol. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as Carboxilic acids, C6-18 and C8-15-di, polymers with diethylene glycol, glycerol, oleic acid, phthalic, acid and sorbitol (CAS: 1877295-51-6) (PMN P-16-570) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the PMN substance after they have been completely reacted (cured). (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(2)(i), (ii), (iii), (a)(3), 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)(concentrations set at 0.1%) and (c). (ii) Hazard communication. Requirements as specified in Sec. 721.72(a), (b), (c), (d), (e)(concentration set at 1.0%), (f), (g)(1)(vi), (ix), (g)(2)(i), (ii), (iii), (v), (g)(3)(i), (g)(4)(iii) and (g)(5). Alternative hazard and warning [[Page 43538]] 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 use the substance other than as an aromatic polyester polyol for manufacturing rigid foam. It is a significant new use to manufacture the substance with residual phthalate greater than 0.1% by weight. It is a significant new use to modify the manufacturing, processing or use activities of the PMN substance to result in the generation of a vapor, mist or aerosol. (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 (b). (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. 2018-18534 Filed 8-24-18; 8:45 am] BILLING CODE 6560-50-P
![Federal Register / Vol. 83, No. 166 / Monday, August 27, 2018 / Rules and Regulations 43527
F. Environment day, two hours prior to, thirty minutes ENVIRONMENTAL PROTECTION
We have analyzed this rule under during, and thirty minutes after the AGENCY
Department of Homeland Security completion of demolition at the
Directive 023–01 and Commandant Dairyland Power Cooperative Station in 40 CFR Parts 9 and 721
Instruction M16475.1D, which guide the Alma, WI. The Captain of the Port [EPA–HQ–OPPT–2017–0560; FRL–9982–77]
Coast Guard in complying with the Sector Upper Mississippi River (COTP)
RIN 2070–AB27
National Environmental Policy Act of or a designated representative will
1969 (42 U.S.C. 4321–4370f), and have inform the public of the enforcement Significant New Use Rules on Certain
determined that this action is one of a through Broadcast Notices to Mariners Chemical Substances
category of actions that do not (BNMs), Local Notices to Mariners
individually or cumulatively have a (LNMs) and/or Safety Marine AGENCY: Environmental Protection
significant effect on the human Information Broadcasts (SMIBs) or other Agency (EPA).
environment. This rule involves safety means of public notice at least three ACTION: Direct final rule.
zone that impacts a less than a one-mile hours in advance of the enforcement of
stretch of the Upper Mississippi River SUMMARY: EPA is promulgating
this safety zone. significant new use rules (SNURs) under
for approximately three hours on one
day. It is categorically excluded from (d) Regulations. (1) In accordance the Toxic Substances Control Act
further review under paragraph L60(a) with the general regulations in § 165.23 (TSCA) for 10 chemical substances
of Appendix A, Table 1 of DHS of this part, persons and vessels are which were the subject of
Instruction Manual 023–01–001–01, prohibited from entering the safety zone premanufacture notices (PMNs). The
Rev. 01. A Record of Environmental unless authorized by the COTP or a chemical substances are subject to
Consideration supporting this designated representative. A designated Orders issued by EPA pursuant to
determination is available in the docket representative is a commissioned, section 5(e) of TSCA. This action
where indicated under ADDRESSES. warrant, or petty officer of the U.S. requires persons who intend to
Coast Guard assigned to units under the manufacture (defined by statute to
G. Protest Activities include import) or process any of these
operational control of USCG Sector
The Coast Guard respects the First Upper Mississippi River. A designated 10 chemical substances for an activity
Amendment rights of protesters. representative may be a Patrol that is designated as a significant new
Protesters are asked to contact the use by this rule to notify EPA at least
Commander (PATCOM). The PATCOM
person listed in the FOR FURTHER 90 days before commencing that
may be aboard either a Coast Guard or
INFORMATION CONTACT section to activity. The required notification
coordinate protest activities so that your Coast Guard Auxiliary vessel. The Patrol
initiates EPA’s evaluation of the
message can be received without Commander may be contacted on
intended use within the applicable
jeopardizing the safety or security of Channel 16 VHF–FM (156.8 MHz) by
review period. Persons may not
people, places or vessels. the call sign ‘‘PATCOM’’. commence manufacture or processing
List of Subjects in 33 CFR Part 165 (2) Persons or vessels desiring to enter for the significant new use until EPA
into or pass through the zone must has conducted a review of the notice,
Harbors, Marine safety, Navigation request permission from the COTP or a made an appropriate determination on
(water), Reporting and recordkeeping designated representative. They may be the notice, and has taken such actions
requirements, Security measures, contacted on VHF–FM channel 16 or by as are required with that determination.
Waterways.
telephone at 314–269–2332. DATES: This rule is effective on October
For the reasons discussed in the 26, 2018. For purposes of judicial
preamble, the Coast Guard amends 33 (3) If permission is granted, all
persons and vessels shall comply with review, this rule shall be promulgated at
CFR part 165 as follows: 1 p.m. (e.s.t.) on September 10, 2018.
the instructions of the COTP or
PART 165—REGULATED NAVIGATION designated representative. Written adverse comments on one or
AREAS AND LIMITED ACCESS AREAS more of these SNURs must be received
(e) Informational broadcasts. The on or before September 26, 2018 (see
■ 1. The authority citation for part 165 COTP or a designated representative Unit VI. of the SUPPLEMENTARY
continues to read as follows: will inform the public through INFORMATION). If EPA receives written
Broadcast Notices to Mariners (BNMs), adverse commentsts, on one or more of
Authority: 33 U.S.C. 1231; 50 U.S.C. 191; Local Notices to Mariners (LNMs) and/ these SNURs before September 26, 2018,
33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5;
and Department of Homeland Security
or Safety Marine Information Broadcasts EPA will withdraw the relevant sections
Delegation No. 0170.1. (SMIBs) or other means of public notice of this direct final rule before its
of the enforcement period for the effective date.
■ 2. Add § 165.T08–0724 to read as For additional information on related
temporary safety zone as well as any
follows: reporting requirement dates, see Units
changes in the dates and times of
§ 165. T08–0742 Safety Zone; Mile Markers enforcement. I.A., VI., and VII. of the SUPPLEMENTARY
751.2 to 751.8, Upper Mississippi River, INFORMATION.
Alma, WI. Dated: August 21, 2018. ADDRESSES: Submit your comments,
(a) Location. The following area is a Stormer, Scott A., identified by docket identification (ID)
safety zone: All navigable waters of the Captain, U.S. Coast Guard, Captain of the number EPA–HQ–OPPT–2017–0560, by
Mississippi River between mile marker Port Sector Upper Mississippi River. one of the following methods:
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(MM) 751.2 and MM 751.8, Alma, WI. [FR Doc. 2018–18453 Filed 8–24–18; 8:45 am] • Federal eRulemaking Portal: http://
(b) Effective period. This section will BILLING CODE 9110–04–P
www.regulations.gov. Follow the online
be enforced from September 28, 2018 instructions for submitting comments.
through October 15, 2018. Do not submit electronically any
(c) Enforcement period. This section information you consider to be
will be enforced for three hours on one Confidential Business Information (CBI)
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![Federal Register / Vol. 83, No. 166 / Monday, August 27, 2018 / Rules and Regulations 43529
EPA determines that the significant new to be conducted by the PMN submitter, risk of injury to human health via
use is not likely to present an as well as testing not required to be inhalation exposure, the underlying
unreasonable risk, EPA is required conducted but which would also help TSCA section 5(e) Order requires,
under TSCA section 5(g) to make public, characterize the potential health and/or among other things, that potentially
and submit for publication in the environmental effects of the PMN exposed employees wear specified
Federal Register, a statement of EPA’s substance. Any recommendation for respirators unless actual measurements
findings. information identified by EPA was of the workplace air show that air-borne
made based on EPA’s consideration of concentrations of the PMN substance
III. Significant New Use Determination
available screening-level data, if any, as are below a New Chemical Exposure
Section 5(a)(2) of TSCA states that well as other available information on Limit (NCEL) that is established by EPA
EPA’s determination that a use of a appropriate testing for the chemical to provide adequate protection to
chemical substance is a significant new substance. Further, any such testing human health. In addition to the actual
use must be made after consideration of identified by EPA that includes testing NCEL concentration, the comprehensive
all relevant factors, including: on vertebrates was made after NCELs provisions in TSCA section 5(e)
• The projected volume of consideration of available toxicity Orders, which are modeled after
manufacturing and processing of a information, computational toxicology Occupational Safety and Health
chemical substance. and bioinformatics, and high- Administration (OSHA) Permissible
• The extent to which a use changes throughput screening methods and their Exposure Limits (PELs) provisions,
the type or form of exposure of human prediction models. EPA also recognizes include requirements addressing
beings or the environment to a chemical that whether testing/further information performance criteria for sampling and
substance. is needed will depend on the specific analytical methods, periodic
• The extent to which a use increases exposure and use scenario in the SNUN. monitoring, respiratory protection, and
the magnitude and duration of exposure EPA encourages all SNUN submitters to recordkeeping. However, no comparable
of human beings or the environment to contact EPA to discuss any potential NCEL provisions currently exist in 40
a chemical substance. future testing. See Unit VIII. for more CFR part 721, subpart B, for SNURs.
• The reasonably anticipated manner information. Therefore, for these cases, the
and methods of manufacturing, • CFR citation assigned in the individual SNURs in 40 CFR part 721,
processing, distribution in commerce, regulatory text section of this rule. subpart E, will state that persons subject
and disposal of a chemical substance. The regulatory text sections of these to the SNUR who wish to pursue NCELs
In addition to these factors rules specify the activities designated as as an alternative to the § 721.63
enumerated in TSCA section 5(a)(2), the significant new uses. Certain new uses, respirator requirements may request to
statute authorizes EPA to consider any including exceedance of production do so under § 721.30. EPA expects that
other relevant factors. volume limits (i.e., limits on
To determine what would constitute a persons whose § 721.30 requests to use
manufacture volume) and other uses the NCELs approach for SNURs that are
significant new use for the 10 chemical designated in this rule, may be claimed
substances that are the subject of these approved by EPA will be required to
as CBI. Unit IX. discusses a procedure comply with NCELs provisions that are
SNURs, EPA considered relevant companies may use to ascertain whether
information about the toxicity of the comparable to those contained in the
a proposed use constitutes a significant corresponding TSCA section 5(e) Order
chemical substances, likely human new use.
exposures and environmental releases for the same chemical substance.
These rules include 10 PMN
associated with possible uses, and the substances that are subject to Orders PMN Number: P–13–307
four bulleted TSCA section 5(a)(2) under TSCA section 5(e)(1)(A). Each Chemical name: Substituted
factors listed in this unit. Order is based on one or more of the carbocycle, N-[[[4-[[(4-substituted
IV. Substances Subject to This Rule findings in TSCA section 5(a)(3)(B): carbocyclic)amino]sulfonyl]carbocyclic]
EPA is establishing significant new There is insufficient information to amino]carbonyl]-4-methyl-(generic).
use and recordkeeping requirements for permit a reasoned evaluation; in the CAS number: Not available.
absence of sufficient information to Effective date of TSCA section 5(e)
10 chemical substances in 40 CFR part
permit a reasoned evaluation, the Order: July 31, 2017.
721, subpart E. In this unit, EPA Basis for TSCA section 5(e) Order:
provides the following information for activities associated with the PMN
substances may present unreasonable The PMN states that the generic (non-
each chemical substance:
risk to human health or the confidential) use of the substance will
• PMN number.
• Chemical name (generic name, if environment; the substance is or will be be as a component of manufactured
the specific name is claimed as CBI). produced in substantial quantities, and consumer article—contained use. Based
• Chemical Abstracts Service (CAS) enters or may reasonably be anticipated on SAR analysis of test data on
Registry number (if assigned for non- to enter the environment in substantial analogous substances, EPA has
confidential chemical identities). quantities or there is or may be identified concerns for systemic toxicity
• Basis for the TSCA section 5(e) significant (substantial) human on the spleen, liver and thymus, blood
Order. exposure to the substance. Those Orders effects, developmental toxicity and
• Information identified by EPA that require protective measures to limit immunotoxicity. Based on SAR analysis
would help characterize the potential exposures or otherwise mitigate the for amides, EPA predicts toxicity to
health and/or environmental effects of potential unreasonable risk. The SNURs aquatic organisms may occur at
the chemical substance in support of a identify as significant new uses any concentrations that exceed 5 parts per
request by the PMN submitter to modify manufacturing, processing, use, billion (ppb) in surface waters. The
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the Order, or if a manufacturer or distribution in commerce, or disposal Order was issued under TSCA sections
processor is considering submitting a that does not conform to the restrictions 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
SNUN for a significant new use imposed by the underlying Orders, based on a finding that in the absence
designated by the SNUR. consistent with TSCA section 5(f)(4). of sufficient information to permit a
This information may include testing Where EPA determines that the PMN reasoned evaluation, the substance may
required in a TSCA section 5(e) Order substance may present an unreasonable present an unreasonable risk of injury to
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![Federal Register / Vol. 83, No. 166 / Monday, August 27, 2018 / Rules and Regulations 43535
• Submission of the SNUN would not Significantly Affect Energy Supply, 6901–6992k, 7401–7671q, 7542, 9601–9657,
cost any small entity significantly more Distribution, or Use’’ (66 FR 28355, May 11023, 11048.
than $8,300. 22, 2001), because this action is not ■ 2. In § 9.1, add the following sections
Therefore, the promulgation of the expected to affect energy supply, in numerical order under the
SNUR would not have a significant distribution, or use and because this undesignated center heading
economic impact on a substantial action is not a significant regulatory ‘‘Significant New Uses of Chemical
number of small entities. action under Executive Order 12866. Substances’’ to read as follows:
D. Unfunded Mandates Reform Act I. National Technology Transfer and § 9.1 OMB approvals under the Paperwork
(UMRA) Advancement Act (NTTAA) Reduction Act.
Based on EPA’s experience with In addition, since this action does not * * * * *
proposing and finalizing SNURs, State, involve any technical standards,
local, and Tribal governments have not NTTAA section 12(d) (15 U.S.C. 272 OMB
40 CFR citation
been impacted by these rulemakings, control No.
note), does not apply to this action.
and EPA does not have any reasons to
believe that any State, local, or Tribal J. Executive Order 12898
* * * * *
government will be impacted by this This action does not entail special
action. As such, EPA has determined considerations of environmental justice Significant New Uses of Chemical
that this action does not impose any related issues as delineated by Substances
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 721.11116 ............................. 2070–0012
requirements of UMRA sections 202, Populations and Low-Income 721.11117 ............................. 2070–0012
203, 204, or 205 (2 U.S.C. 1501 et seq.). Populations’’ (59 FR 7629, February 16, 721.11118 ............................. 2070–0012
1994). 721.11119 ............................. 2070–0012
E. Executive Order 13132 721.11120 ............................. 2070–0012
This action will not have a substantial XIII. Congressional Review Act 721.11121 ............................. 2070–0012
direct effect on States, on the 721.11122 ............................. 2070–0012
Pursuant to the Congressional Review
relationship between the national 721.11123 ............................. 2070–0012
Act (5 U.S.C. 801 et seq.), EPA will
government and the States, or on the submit a report containing this rule and * * * * *
distribution of power and other required information to the U.S.
responsibilities among the various Senate, the U.S. House of * * * * *
levels of government, as specified in Representatives, and the Comptroller
Executive Order 13132, entitled General of the United States prior to PART 721—[AMENDED]
‘‘Federalism’’ (64 FR 43255, August 10, publication of the rule in the Federal
1999). Register. This action is not a ‘‘major ■ 3. The authority citation for part 721
rule’’ as defined by 5 U.S.C. 804(2). continues to read as follows:
F. Executive Order 13175
Authority: 15 U.S.C. 2604, 2607, and
This action does not have Tribal List of Subjects 2625(c).
implications because it is not expected 40 CFR Part 9 ■ 4. Add § 721.11116 to subpart E to
to have substantial direct effects on read as follows:
Indian Tribes. This action does not Environmental protection, Reporting
significantly nor uniquely affect the and recordkeeping requirements. § 721.11116 Substituted carbocycle, N-[[[4-
communities of Indian Tribal [[(4-substituted carbocyclic)amino]sulfonyl]
40 CFR Part 721 carbocyclic]amino]carbonyl]-4-methyl-
governments, nor does it involve or
impose any requirements that affect Environmental protection, Chemicals, (generic).
Indian Tribes. Accordingly, the Hazardous substances, Reporting and (a) Chemical substance and
requirements of Executive Order 13175, recordkeeping requirements. significant new uses subject to reporting.
entitled ‘‘Consultation and Coordination Dated: August 20, 2018. (1) The chemical substance identified as
with Indian Tribal Governments’’ (65 FR Jeffery T. Morris,
substituted carbocycle, N-[[[4-[[(4-
67249, November 9, 2000), do not apply substituted carbocyclic)amino]sulfonyl]
Director, Office of Pollution Prevention and
to this action. Toxics.
carbocyclic]amino]carbonyl]-4-methyl-
(PMN P–13–307) is subject to reporting
G. Executive Order 13045 Therefore, 40 CFR parts 9 and 721 are under this section for the significant
This action is not subject to Executive amended as follows: new uses described in paragraph (a)(2)
Order 13045, entitled ‘‘Protection of of this section.
Children from Environmental Health PART 9—[AMENDED] (2) The significant new uses are:
Risks and Safety Risks’’ (62 FR 19885, (i) Protection in the workplace.
■ 1. The authority citation for part 9 Requirements as specified in
April 23, 1997), because this is not an
continues to read as follows: § 721.63(a)(1), (a)(2)(i), (a)(3), (a)(4)
economically significant regulatory
action as defined by Executive Order Authority: 7 U.S.C. 135 et seq., 136–136y; (when determining which persons are
12866, and this action does not address 15 U.S.C. 2001, 2003, 2005, 2006, 2601–2671; reasonably likely to be exposed as
21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 required for § 721.63(a)(1) and (4),
environmental health or safety risks
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U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, engineering control measures (e.g.,
disproportionately affecting children. 1321, 1326, 1330, 1342, 1344, 1345 (d) and
enclosure or confinement of the
H. Executive Order 13211 (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,
1971–1975 Comp. p. 973; 42 U.S.C. 241, operation, general and local ventilation)
This action is not subject to Executive 242b, 243, 246, 300f, 300g, 300g–1, 300g–2, or administrative control measures (e.g.,
Order 13211, entitled ‘‘Actions 300g–3, 300g–4, 300g–5, 300g–6, 300j–1, workplace policies and procedures)
Concerning Regulations That 300j–2, 300j–3, 300j–4, 300j–9, 1857 et seq., shall be considered and implemented to
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![43536 Federal Register / Vol. 83, No. 166 / Monday, August 27, 2018 / Rules and Regulations
prevent exposure, where feasible), P–16–316 and P–16–317) are subject to aerosols at concentrations greater than 1
(a)(5)(respirators must provide a reporting under this section for the percent by weight or volume.
National Institute for Occupational significant new uses described in (b) Specific requirements. The
Safety and Health (NIOSH) assigned paragraph (a)(2) of this section. provisions of subpart A of this part
protection factor of at least 10 or (2) The significant new uses are: apply to this section except as modified
maintain workplace airborne (i) Industrial, commercial, and by this paragraph (b).
concentrations), (a)(6)(particulate), consumer activities. Requirements as (1) Recordkeeping. Recordkeeping
(b)(concentrations set at 1.0%) and (c). specified in § 721.80(k). It is a requirements as specified in
(A) As an alternative to the respirator significant new use to manufacture the § 721.125(a), (b), (c), (f), (g), (h), and (i)
requirements in paragraph (a)(2)(i) of PMN substances with an average are applicable to manufacturers and
this section, a manufacturer or processor molecular weight lower than 22,000 processors of this substance.
may choose to follow the new chemical daltons for P16–316 and lower than (2) Limitations or revocation of
exposure limit (NCEL) provision listed 14,000 daltons for P–16–317 and certain notification requirements. The
in the TSCA section 5(e) Order for this containing more than 2% by weight of provisions of § 721.185 apply to this
substance. The NCEL is 4 mg/m3 as an molecular weight species less than 500 section.
8-hour time weighted average. Persons daltons. ■ 7. Add § 721.11119 to subpart E to
who wish to pursue NCELs as an (ii) [Reserved] read as follows:
alternative to § 721.63 respirator (b) Specific requirements. The
requirements may request to do so provisions of subpart A of this part § 721.11119 Functionalized polyimide
under § 721.30. Persons whose § 721.30 apply to this section except as modified (generic).
requests to use the NCELs approach are by this paragraph (b). (a) Chemical substance and
approved by EPA will be required to (1) Recordkeeping. Recordkeeping significant new uses subject to reporting.
follow NCELs provisions comparable to requirements as specified in (1) The chemical substances identified
those contained in the corresponding § 721.125(a) through (c) and (i) are as functionalized polyimide (PMN P–
TSCA section 5(e) Order. applicable to manufacturers and 16–406 and P–16–407) are subject to
(B) [Reserved] processors of these substances. reporting under this section for the
(ii) Hazard communication. (2) Limitations or revocation of significant new uses described in
Requirements as specified in certain notification requirements. The paragraph (a)(2) of this section.
§ 721.72(a), (b), (c), (d), (e)(concentration provisions of § 721.185 apply to this (2) The significant new uses are:
set at 1.0%), (f), (g)(1)(iv), (viii), (ix), section. (i) Industrial, commercial, and
(g)(2)(ii), (iii), (use respiratory protection (3) Determining whether a specific use consumer activities. Requirements as
or maintain workplace airborne is subject to this section. The provisions specified in § 721.80(y)(1) and (2). It is
concentrations below an 8-hour time- of § 721.1725(b)(1) apply to paragraph a significant new use to use the
weighted average of 4 mg/m3), (g)(2)(v), (a)(2)(i) of this section. substances other than as a coating for
(g)(4)(i), (ii) and (g)(5). Alternative ■ 6. Add § 721.11118 to subpart E to solid substrates. Any manufacturing
hazard and warning statements that read as follows: process that results in inhalation
meet the criteria of the Globally exposure to the substances is a
§ 721.11118 Modified acrylic polymer significant new use.
Harmonized System (GHS) and OSHA
(generic). (ii) [Reserved]
Hazard Communication Standard may
be used. (a) Chemical substance and (b) Specific requirements. The
(iii) Industrial, commercial, and significant new uses subject to reporting. provisions of subpart A of this part
consumer activities. Requirements as (1) The chemical substance identified apply to this section except as modified
specified in § 721.80(f), (k) and (q). generically as modified acrylic polymer by this paragraph (b).
(iv) Release to water. Requirements as (PMN P–16–342) is subject to reporting (1) Recordkeeping. Recordkeeping
specified in § 721.90(a)(4), (b)(4), and under this section for the significant requirements as specified in
(c)(4) where N = 30 ppb. new uses described in paragraph (a)(2) § 721.125(a) through (c) and (i) are
(b) Specific requirements. The of this section. applicable to manufacturers and
provisions of subpart A of this part (2) The significant new uses are: processors of these substances.
apply to this section except as modified (i) Hazard communication. (2) Limitations or revocation of
by this paragraph (b). Requirements as specified in certain notification requirements. The
(1) Recordkeeping. Recordkeeping § 721.72(a), (b), (c), (d), (e)(concentration provisions of § 721.185 apply to this
requirements as specified in set at 1.0%), (f), (g)(1)(ii), (g)(2)(ii), and section.
§ 721.125(a), (i) and (k). (g)(5). Alternative hazard and warning ■ 8. Add § 721.11120 to subpart E to
(2) Limitations or revocation of statements that meet the criteria of the read as follows:
certain notification requirements. The Globally Harmonized System (GHS) and
provisions of § 721.185 apply to this OSHA Hazard Communication Standard § 721.11120 Siloxanes and Silicones, di-
section. may be used. Me, 3-hydroxypropyl Me, Me
(3) Determining whether a specific use (ii) Industrial, commercial, and 3,3,4,4,5,5,6,6,6-nonafluorohexyl.
is subject to this section. The provisions consumer activities. Requirements as (a) Chemical substance and
of § 721.1725(b)(1) apply to paragraph specified in § 721.80(f). It is a significant significant new uses subject to reporting.
(a)(2)(iii) of this section. new use for any use other than as a (1) The chemical substance identified as
■ 5. Add § 721.11117 to subpart E to dispersant for deflocculation of siloxanes and silicones, di-Me, 3-
pigments in industrial paints and hydroxypropyl Me, Me 3,3,4,4,5,5,6,6,6-
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read as follows:
coatings, any use in the paint/coating nonafluorohexyl (CAS: 1610862–54–8)
§ 721.11117 Aliphatic polyester (generic). formulation at concentration greater (PMN P–16–413) is subject to reporting
(a) Chemical substance and than 1 percent by weight or volume, and under this section for the significant
significant new uses subject to reporting. any use of the substance that would new uses described in paragraph (a)(2)
(1) The chemical substances identified allow inhalation exposure to the of this section.
generically as aliphatic polyester (PMNs substance by vapor, dust, mist or (2) The significant new uses are:
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![Federal Register / Vol. 83, No. 166 / Monday, August 27, 2018 / Rules and Regulations 43537
(i) Industrial, commercial, and alternative to § 721.63 respirator peroxide-initiated (PMN P–16–503) is
consumer activities. Requirements are requirements may request to do so subject to reporting under this section
described in § 721.80(f) and (p)(40,000 under § 721.30. Persons whose § 721.30 for the significant new uses described in
kilograms and 151,300 kilograms). It is requests to use the NCELs approach are paragraph (a)(2) of this section.
a significant new use to process or use approved by EPA will be required to (2) The significant new uses are:
the PMN substance in a manner that follow NCELs provisions comparable to (i) Industrial, commercial, and
results in inhalation exposure to spray, those contained in the corresponding consumer activities. Requirements as
mist or aerosol. TSCA section 5(e) Order. specified in § 721.80(g). It is a
(ii) Release to water. Requirements as (B) [Reserved] significant new use to manufacture the
specified in § 721.90(a)(1), (b)(1), and (ii) Hazard communication. substance with an average molecular
(c)(1). Requirements as specified in weight lower than 1,500 dalton or more
(b) Specific requirements. The § 721.72(a), (b), (c), (d), (e)(concentration than 24% by weight of acid monomer in
provisions of subpart A of this part set at 0.1%), (f), (g)(1)(lung effects), the polymer.
apply to this section except as modified (g)(1)(vii), (g)(2)(ii), (iii), (g)(2)(use (ii) [Reserved]
by this paragraph (b). respiratory protection or maintain (b) Specific requirements. The
(1) Recordkeeping. Recordkeeping workplace airborne concentrations provisions of subpart A of this part
requirements as specified in below an 8-hour time-weighted average apply to this section except as modified
§ 721.125(a) through (c), (i), and (k) are of 0.3 mg/m3), (g)(3)(ii), (g)(4)(i), (iii) by this paragraph (b).
applicable to manufacturers and and (g)(5). Alternative hazard and (1) Recordkeeping. Recordkeeping
processors of this substance. warning statements that meet the requirements as specified in
(2) Limitations or revocation of criteria of the Globally Harmonized § 721.125(a) through (c) and (i) are
certain notification requirements. The System (GHS) and OSHA Hazard applicable to manufacturers and
provisions of § 721.185 apply to this Communication Standard may be used. processors of this substance.
section. (iii) Industrial, commercial, and (2) Limitations or revocation of
■ 9. Add § 721.11121 to subpart E to consumer activities. Requirements as certain notification requirements. The
read as follows: specified in § 721.80(q). It is a provisions of § 721.185 apply to this
significant new to use the substance section.
§ 721.11121 Sodium tungsten oxide.
other than as a component of infrared ■ 11. Add § 721.11123 to subpart E to
(a) Chemical substance and absorption material. It is a significant read as follows:
significant new uses subject to reporting. new use to use involving an application
(1) The chemical substance identified as method that generates a dust, mist, or § 721.11123 Carboxilic acids, C6–18 and
sodium tungsten oxide (CAS No. 11120– aerosol, unless the application method
C8–15-di, polymers with diethylene glycol,
01–7) (PMN P–16–455) is subject to glycerol, oleic acid, phthalic, acid and
occurs within an enclosed process. sorbitol.
reporting under this section for the (iv) Disposal. Requirements as
significant new uses described in (a) Chemical substance and
specified in § 721.85(a)(1), (2), (b)(1), (2),
paragraph (a)(2) of this section. The significant new uses subject to reporting.
(c)(1), and (2).
requirements of this section do not (v) Release to water. Requirements as (1) The chemical substance identified as
apply to quantities of the PMN specific in § 721.90(a)(1), (b)(1), and Carboxilic acids, C6–18 and C8–15-di,
substance after they have been (c)(1). polymers with diethylene glycol,
incorporated into a polymer matrix. (b) Specific requirements. The glycerol, oleic acid, phthalic, acid and
(2) The significant new uses are: provisions of subpart A of this part sorbitol (CAS: 1877295–51–6) (PMN P–
(i) Protection in the workplace. apply to this section except as modified 16–570) is subject to reporting under
Requirements as specified in by this paragraph (b). this section for the significant new uses
§ 721.63(a)(1), (a)(2)(i), (a)(3), (1) Recordkeeping. Recordkeeping described in paragraph (a)(2) of this
(a)(4)(when determining which persons requirements as specified in section. The requirements of this section
are reasonably likely to be exposed as § 721.125(a) through (k) are applicable do not apply to quantities of the PMN
required for § 721.63(a)(1) and (4), to manufacturers and processors of this substance after they have been
engineering control measures (e.g., substance. completely reacted (cured).
enclosure or confinement of the (2) Limitations or revocation of (2) The significant new uses are:
operation, general and local ventilation) certain notification requirements. The (i) Protection in the workplace.
or administrative control measures (e.g., provisions of § 721.185 apply to this Requirements as specified in
workplace policies and procedures) section. § 721.63(a)(1), (a)(2)(i), (ii), (iii), (a)(3),
shall be considered and implemented to (3) Determining whether a specific use when determining which persons are
prevent exposure, where feasible), is subject to this section. The provisions reasonably likely to be exposed as
(a)(5)(respirators must provide a of § 721.1725(b)(1) apply to paragraph required for § 721.63(a)(1) engineering
National Institute for Occupational (a)(2)(iii) of this section. control measures (e.g., enclosure or
Safety and Health (NIOSH) assigned confinement of the operation, general
■ 10. Add § 721.11122 to subpart E to
protection factor of at least 1000, and local ventilation) or administrative
read as follows:
(a)(6)(particulate), (b)(concentrations set control measures (e.g., workplace
at 0.1%) and (c). § 721.11122 Fatty acids, tall-oil, polymers policies and procedures) shall be
(A) As an alternative to the respirator with alkanoic acid, substituted considered and implemented to prevent
requirements in paragraph (a)(2)(i) of carbomonocycle, alkyl peroxide-initiated exposure, where feasible,
this section, a manufacturer or processor (generic). (b)(concentrations set at 0.1%) and (c).
amozie on DSK3GDR082PROD with RULES
may choose to follow the new chemical (a) Chemical substance and (ii) Hazard communication.
exposure limit (NCEL) provision listed significant new uses subject to reporting. Requirements as specified in
in the TSCA section 5(e) Order for this (1) The chemical substance identified § 721.72(a), (b), (c), (d), (e)(concentration
substance. The NCEL is 0.3 mg/m3 as an generically as fatty acids, tall-oil, set at 1.0%), (f), (g)(1)(vi), (ix), (g)(2)(i),
8-hour time weighted average. Persons polymers with alkanoic acid, (ii), (iii), (v), (g)(3)(i), (g)(4)(iii) and
who wish to pursue NCELs as an substituted carbomonocycle, alkyl (g)(5). Alternative hazard and warning
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![43538 Federal Register / Vol. 83, No. 166 / Monday, August 27, 2018 / Rules and Regulations
statements that meet the criteria of the 19 chemical substances for an activity For general information contact: The
Globally Harmonized System (GHS) and that is designated as a significant new TSCA-Hotline, ABVI-Goodwill, 422
OSHA Hazard Communication Standard use by this rule to notify EPA at least South Clinton Ave., Rochester, NY
may be used. 90 days before commencing that 14620; telephone number: (202) 554–
(iii) Industrial, commercial, and activity. The required notification 1404; email address: TSCA-Hotline@
consumer activities. Requirements as initiates EPA’s evaluation of the epa.gov.
specified in § 721.80(q). It is a intended use within the applicable SUPPLEMENTARY INFORMATION:
significant new use to use the substance review period. Persons may not
other than as an aromatic polyester commence manufacture or processing I. General Information
polyol for manufacturing rigid foam. It for the significant new use until EPA A. Does this action apply to me?
is a significant new use to manufacture has conducted a review of the notice,
the substance with residual phthalate made an appropriate determination on You may be potentially affected by
greater than 0.1% by weight. It is a the notice, and has taken such actions this action if you manufacture, process,
significant new use to modify the as are required with that determination. or use the chemical substances
manufacturing, processing or use contained in this rule. The following list
DATES: This rule is effective on October
activities of the PMN substance to result of North American Industrial
26, 2018. For purposes of judicial Classification System (NAICS) codes is
in the generation of a vapor, mist or review, this rule shall be promulgated at
aerosol. not intended to be exhaustive, but rather
1 p.m. (e.s.t.) on September 10, 2018. provides a guide to help readers
(iv) Release to water. Requirements as Written adverse comments on one or
specified in § 721.90(a)(1), (b)(1), and determine whether this document
more of these SNURs must be received applies to them. Potentially affected
(c)(1). on or before September 26, 2018 (see
(b) Specific requirements. The entities may include:
Unit VI. of the SUPPLEMENTARY • Manufacturers or processors of one
provisions of subpart A of this part INFORMATION). If EPA receives written or more subject chemical substances
apply to this section except as modified adverse comments on one or more of (NAICS codes 325 and 324110), e.g.,
by this paragraph (b). these SNURs before September 26, 2018, chemical manufacturing and petroleum
(1) Recordkeeping. Recordkeeping EPA will withdraw the relevant sections refineries.
requirements as specified in of this direct final rule before its This action may also affect certain
§ 721.125(a) through (i) and (k) are effective date. entities through pre-existing import
applicable to manufacturers and For additional information on related certification and export notification
processors of this substance. reporting requirement dates, see Units rules under TSCA. Chemical importers
(2) Limitations or revocation of I.A., VI., and VII. of the SUPPLEMENTARY are subject to the TSCA section 13 (15
certain notification requirements. The INFORMATION. U.S.C. 2612) import certification
provisions of § 721.185 apply to this ADDRESSES: Submit your comments, requirements promulgated at 19 CFR
section. identified by docket identification (ID) 12.118 through 12.127 and 19 CFR
(3) Determining whether a specific use number EPA–HQ–OPPT–2017–0464, by 127.28. Chemical importers must certify
is subject to this section. The provisions one of the following methods: that the shipment of the chemical
of § 721.1725(b)(1) apply to paragraph • Federal eRulemaking Portal: http:// substance complies with all applicable
(a)(2)(iii) of this section. www.regulations.gov. Follow the online rules and orders under TSCA. Importers
[FR Doc. 2018–18534 Filed 8–24–18; 8:45 am] instructions for submitting comments. of chemicals subject to these SNURs
BILLING CODE 6560–50–P Do not submit electronically any must certify their compliance with the
information you consider to be SNUR requirements. The EPA policy in
Confidential Business Information (CBI) support of import certification appears
ENVIRONMENTAL PROTECTION or other information whose disclosure is at 40 CFR part 707, subpart B. In
AGENCY restricted by statute. addition, any persons who export or
• Mail: Document Control Office intend to export a chemical substance
40 CFR Parts 9 and 721 (7407M), Office of Pollution Prevention that is the subject of this rule on or after
[EPA–HQ–OPPT–2017–0464; FRL–9982–24] and Toxics (OPPT), Environmental September 26, 2018 are subject to the
Protection Agency, 1200 Pennsylvania export notification provisions of TSCA
RIN 2070–AB27 Ave. NW, Washington, DC 20460–0001. section 12(b) (15 U.S.C. 2611(b)) (see
• Hand Delivery: To make special § 721.20), and must comply with the
Significant New Use Rules on Certain arrangements for hand delivery or
Chemical Substances export notification requirements in 40
delivery of boxed information, please CFR part 707, subpart D.
AGENCY: Environmental Protection follow the instructions at http://
Agency (EPA). www.epa.gov/dockets/contacts.html. B. What should I consider as I prepare
Additional instructions on my comments for EPA?
ACTION: Direct final rule.
commenting or visiting the docket, 1. Submitting CBI. Do not submit this
SUMMARY: EPA is promulgating along with more information about information to EPA through
significant new use rules (SNURs) under dockets generally, is available at http:// regulations.gov or email. Clearly mark
the Toxic Substances Control Act www.epa.gov/dockets. the part or all of the information that
(TSCA) for 19 chemical substances FOR FURTHER INFORMATION CONTACT: you claim to be CBI. For CBI
which were the subject of For technical information contact: information in a disk or CD–ROM that
premanufacture notices (PMNs). The Kenneth Moss, Chemical Control you mail to EPA, mark the outside of the
amozie on DSK3GDR082PROD with RULES
chemical substances are subject to Division (7405M), Office of Pollution disk or CD–ROM as CBI and then
Orders issued by EPA pursuant to Prevention and Toxics, Environmental identify electronically within the disk or
section 5(e) of TSCA. This action Protection Agency, 1200 Pennsylvania CD–ROM the specific information that
requires persons who intend to Ave. NW, Washington, DC 20460–0001; is claimed as CBI. In addition to one
manufacture (defined by statute to telephone number: (202) 564–9232; complete version of the comment that
include import) or process any of these email address: moss.kenneth@epa.gov. includes information claimed as CBI, a
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Document Created: 2018-08-25 01:48:22
Document Modified: 2018-08-25 01:48:22
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Direct final rule. | |
| Dates | This rule is effective on October 26, 2018. For purposes of judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on September 10, 2018. | |
| Contact | For technical information contact: Kenneth Moss, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, | |
| FR Citation | 83 FR 43527 | |
| 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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