82 FR 48637 - Significant New Use Rules on Certain Chemical Substances
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 82, Issue 201 (October 19, 2017)
Federal Register Volume 82, Issue 201 (October 19, 2017)
| Page Range | 48637-48655 | |
| FR Document | 2017-22239 |
[Federal Register Volume 82, Number 201 (Thursday, October 19, 2017)] [Rules and Regulations] [Pages 48637-48655] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-22239] ======================================================================= ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 9 and 721 [EPA-HQ-OPPT-2017-0166; FRL-9964-42] 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 29 chemical substances which were the subject of premanufacture notices (PMNs). The chemical substances are subject to consent orders issued by EPA pursuant to section 5(e) of TSCA. This action requires persons who intend to manufacture (defined by statute to include import) or process any of these 29 chemical substances for an activity that is designated as a significant new use by this rule to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA's evaluation of the intended use within the applicable review period. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required with that determination. DATES: This rule is effective on December 18, 2017. For purposes of judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on November 2, 2017. Written adverse or critical comments, or notice of intent to submit adverse or critical comments, on one or more of these SNURs must be received on or before November 20, 2017 (see Unit VI. of the SUPPLEMENTARY INFORMATION). If EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments, on one or more of these SNURs before November 20, 2017, 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-2017-0166, by one of the following methods:Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Mail: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001. Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: For technical information contact: Kenneth Moss, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (202) 564-9232; email address: moss.kenneth @epa.gov. For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address: TSCA-Hotline@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this action apply to me? You may be potentially affected by this action if you manufacture, process, or use the chemical substances contained in this rule. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include: Manufacturers or processors of one or more subject chemical substances (NAICS codes 325 and 324110), e.g., chemical manufacturing and petroleum refineries. This action may also affect certain entities through pre-existing import certification and export notification [[Page 48638]] 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, pursuant to 40 CFR 721.20, any persons who export or intend to export a chemical substance that is the subject of this rule on or after November 20, 2017 are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) 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? EPA is promulgating these SNURs using direct final procedures. These SNURs will require persons to notify EPA at least 90 days before commencing the manufacture or processing of a chemical substance for any activity designated by these SNURs as a significant new use. Receipt of such notices allows EPA to assess risks that may be presented by the intended uses and, if appropriate, to regulate the proposed use before it occurs. Additional rationale and background to these rules are more fully set out in the preamble to EPA's first direct final SNUR published in the Federal Register issue of April 24, 1990 (55 FR 17376). Consult that preamble for further information on the objectives, rationale, and procedures for SNURs and on the basis for significant new use designations, including provisions for developing test data. 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)(i) (15 U.S.C. 2604(a)(1)(B)(i)) 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. TSCA 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. Pursuant 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) (15 U.S.C. 2604(a)(1)(A)). In particular, these requirements include the information submission requirements of TSCA sections 5(b) and 5(d)(1) (15 U.S.C. 2604(b) and 2604(d)(1)), the exemptions authorized by TSCA sections 5(h)(1), 5(h)(2), 5(h)(3), and 5(h)(5) (15 U.S.C. 2604(h)(1), 2604(h)(2), 2604(h)(3), and 2604(h)(5)), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA must either determine that the significant new use is not likely to present an unreasonable risk of injury or take such regulatory action as is associated with an alternative determination before the manufacture or processing for the significant new use can commence. If EPA determines that the significant new use is not likely to present an unreasonable risk, EPA is required under TSCA section 5(g) (15 U.S.C. 2604(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 authorized EPA to consider any other relevant factors. To determine what would constitute a significant new use for the 37 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 29 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 consent order under TSCA section 5(e) (15 U.S.C. 2604(e)). Tests recommended by EPA to provide sufficient information to evaluate the chemical substance (see Unit VIII. for more information). CFR citation assigned in the regulatory text section of this rule. The regulatory text section of this rule specifies the activities designated as [[Page 48639]] significant new uses. Certain new uses, including 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. This rule includes 29 PMN substances that are subject to ``risk- based'' consent orders under TSCA section 5(e)(1)(A)(ii)(I) (15 U.S.C. 2604(e)(1)(A)(ii)(I)) where EPA determined that activities associated with the PMN substances may present unreasonable risk to human health or the environment. Those consent orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The SNURs are promulgated pursuant to Sec. 721.160, and are based on and consistent with the provisions in the underlying consent orders. The SNURs designate as a ``significant new use'' the absence of the protective measures required in the corresponding consent orders. Where EPA determined that the PMN substance may present an unreasonable risk of injury to human health via inhalation exposure, the underlying TSCA section 5(e) consent order usually requires, among other things, that potentially exposed employees wear specified respirators unless actual measurements of the workplace air show that air-borne concentrations of the PMN substance are below a New Chemical Exposure Limit (NCEL) that is established by EPA to provide adequate protection to human health. In addition to the actual NCEL concentration, the comprehensive NCELs provisions in TSCA section 5(e) consent 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 requests under Sec. 721.30 to use the NCELs approach for SNURs 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) consent order for the same chemical substance. PMN Number: P-15-310 Chemical name: 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters. CAS number: Not available. Effective date of TSCA section 5(e) consent order: January 31, 2017. Basis for TSCA section 5(e) consent order: The PMN states that the PMN substance will be used as a lubricant in special chain oils for conveyor belts. Based on submitted test data, EPA predicts blood and adrenal gland effects to unprotected workers from repeated dermal exposures. EPA also predicts endocrine disruption based on Structure Activity Relationship (SAR) analysis on analogous phthalates. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that the substance may present an unreasonable risk of injury to human health. To protect against these risks, the consent order requires: 1. Use of personal protective equipment to prevent dermal exposure. 2. Not use, formulate, or distribute for use other than as stated in the PMN. 3. No manufacture beyond an annual production volume of 150,000 kg. Recommended testing: EPA has determined that the results of certain human health toxicity testing would help characterize the PMN substance. The submitter has agreed not to exceed the confidential production limit without performing an Extended One-Generation Reproductive Toxicity Study (OECD Test Guideline 443). CFR citation: 40 CFR 721.10996. PMN Numbers: P-15-487, P-15-488, P-15-489, P-15-490, and P-15-491 Chemical names: Multi-walled carbon nanotubes (generic). CAS numbers: Not available. Effective date of TSCA section 5(e) consent order: February 17, 2017. Basis for TSCA section 5(e) consent order: The PMN states that the PMN substances will be used as additives for electro-static discharge (ESD) in electronic devices, electronics, and materials; additives for weight reduction in materials; additives to improve mechanical properties or electrical conductivities; heat-generating elements in heating devices and materials; additives for heat transfer and thermal emissions in electronic devices and materials; semi-conductor, conductive, or resistive elements in electronic circuitry and devices; additives to improve conductivity in electronic circuitry, energy storage systems, and devices; electron emitters for lighting and x-ray sources; additive for electromagnetic interface shielding in electronic devices; additives for electrodes in electronic materials and electronic devices; catalyst support in chemical manufacturing; coating additives to improve corrosion resistance or conductive properties; additives for fibers in structural and electrical applications; additives for fibers in fabrics and textiles; filter additives to remove nanoscale materials; semi-conducting compounding additives far high-voltage cable; and additives for super-hydrophobicity. A submitted 90-day inhalation toxicity study for P-15-487 demonstrated no effects at 1 mg/m\3\, which was the highest dose tested. Based on SAR analysis on analogous carbon nanotubes (CNT), EPA predicts pulmonary toxicity and oncogenicity to unprotected workers from repeated inhalation exposures. No ecotoxicity studies on CNT are available in which a broad range of production methods, sources, purification, functionalization, etc. were investigated. EPA expects that some fraction of the PMN substances, if released into the environment, will eventually become suspended in water. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that the substances may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the consent order requires: 1. Use of personal protective equipment to prevent dermal exposure and a NIOSH-certified respirator with N-100, P-100, or R-100 cartridges with an assigned protection factor (APF) of at least 50 (where there is a potential for inhalation exposure). 2. Use of the PMN substances only for the uses specified in the consent order. 3. No use in application methods that generate a dust, mist, or aerosol unless such application method occurs in an enclosed process. 4. No use of the PMN substances resulting in releases to surface waters and disposal of the PMN substances only by landfill or incineration. Recommended testing: EPA has determined that a subchronic 90-day inhalation toxicity study (OPPTS 870.3465 or OECD 413), a two-year inhalation bioassay (OPPTS 870.4200), a fish early-life stage toxicity test (OCSPP Test Guideline 850.1400), a daphnid chronic toxicity test (OCSPP Test Guideline 850.1300), and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize possible health and environmental [[Page 48640]] effects of the substances. Although the Order does not require these tests, the Order's restrictions on manufacture, processing, distribution in commerce, and disposal will remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information. CFR citation: 40 CFR 721.10997. PMN Number: P-16-165 Chemical name: Propanoic acid, iron (2+) salt (2:1). CAS number: 1952336-63-8. Effective date of TSCA section 5(e) consent order: February 15, 2017. Basis for TSCA section 5(e) consent order: The PMN states that the PMN substance will be used as a component in a metal organic product that will be used in paint and ink driers, unsaturated polyester resins promoters, lube/grease additives, fuel additives, polymerization catalysts, and specialty petrochemical catalysts at less than 1 percent. Based on submitted test data, EPA predicts liver and developmental toxicity to unprotected workers from repeated inhalation exposures. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that the substance may present an unreasonable risk of injury to human health. To protect against these risks, the consent order requires: 1. Use of a NIOSH-certified respirator with an APF of at least 10 (where there is a potential for inhalation exposures). 2. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the Safety Data Sheet (SDS). 3. No manufacture beyond an annual production volume of 150,000 kg. 4. Not process or use the PMN substance for non-industrial applications. 5. Not process or use the PMN substance in formulations where the concentration is greater than 1%. Recommended testing: EPA has determined that the results of certain human health toxicity testing would help characterize the PMN substance. The submitter has agreed not to exceed the confidential production limit without performing the prenatal development toxicity study (OECD 414). In addition, EPA has determined that the results of a combined chronic toxicity and carcinogenicity toxicity test (OPPTS 870.4300) would help characterize the health effects of the PMN substance. The Order's restrictions on manufacture, processing, distribution in commerce, and disposal will remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information. CFR citation: 40 CFR 721.10998. PMN Numbers: P-16-255, P-16-256, P-16-257, P-16-258, and P-16-259 Chemical names: 1-Butanaminium, N,N,N-tributyl-, carbonic acid (1:1) (P-16-255), 1-Butanaminium, N,N,N-tributyl-, methyl carbonate (1:1) (P-16-256), 1-Butanaminium, N,N,N-tributyl-, ethyl carbonate (1:1) (P-16-257), 1-Butanaminium, N,N,N-tributyl-, propyl carbonate (1:1) (P-16-258), 1-Butanaminium, N,N,N-tributyl-, and 1-methylethyl carbonate (1:1) (P-16-259) CAS numbers: 17351-62-1(P-16-255), 56294-05-2(P-16-256), 478796-04- 2(P-16-257), 1338579-13-7(P-16-258), and 1803407-49-9(P-16-259) Effective date of TSCA section 5(e) consent order: March 7, 2017. Basis for TSCA section 5(e) consent order: The PMN states that the PMN substances will be used as blocked catalysts for paints and coatings. Based on submitted test data, EPA predicts strong irritation to the skin, eyes, and mucous membranes as well as acute toxicity and corrosivity-related neurotoxicity from repeated dermal and inhalation exposures. Further, based on test data on the PMN substances, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 34 parts per billion (ppb) of the PMN substances in surface waters. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that the substances may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the consent order requires: 1. Use of personal protective equipment to prevent dermal exposures. 2. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in a safety data sheet (SDS). 3. Use of the PMN substances only for the use specified in the consent order. 4. Use of the PMN substances at a concentration no greater than 1.5% by weight in the final product. Recommended testing: EPA has determined that the results of certain environmental toxicity testing would help characterize the PMN substances. The submitter has agreed not to exceed the confidential production limit without performing a daphnid chronic toxicity test (OCSPP 850.1300). CFR citations: 40 CFR 721.10999 (P-16-255), 40 CFR 721.11000 (P-16- 256), 40 CFR 721.11001 (P-16-257), 40 CFR 721.11002 (P-16-258), and 40 CFR 721.11003 (P-16-259). PMN Number: P-16-284 Chemical name: Anilino substituted bis-triazinyl derivative of 4,4'-diaminostilbene-2,2'-disulfonic acid, mixed amine sodium salt (generic). CAS number: Not available. Effective date of TSCA section 5(e) consent order: May 12, 2017. Basis for TSCA section 5(e) consent order: The PMN states that the PMN substance will be used as an optical brightener for textiles, paper, and paperboard. Based on submitted test data, EPA predicts adrenal gland effects to unprotected workers from repeated dermal and inhalation exposures. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that the substance may present an unreasonable risk of injury to human health. To protect against these risks, the consent order requires: (1) Import only of the PMN substance as a solution. (2) Use only as an optical brightener for textiles, paper and paperboard. (3) No use of the PMN substance in application methods that generate a dust, mist, or aerosol unless such application method occurs in an enclosed process. (4) Non industrial use only where the PMN substance is not sold for ``consumer use'' or for ``commercial uses'' (as the term is defined in Sec. 721.3) when the ``saleable goods or service'' could introduce PMN material into a ``consumer'' setting (as that term is defined in Sec. 721.3). Recommended testing: EPA has determined that the results of physical/chemistry testing would help characterize the PMN substance. The submitter has agreed not to manufacture beyond a certain time period without measuring the particle size distribution to characterize the particle size distribution of fractions less than 10 microns of the dry particle PMN substance. In addition, EPA has determined that the results of a 90-day subchronic inhalation toxicity study (OPPTS 870.3465 or OECD 413) would help characterize the health effects of the PMN substance. The Order's restrictions on manufacture, processing, distribution in commerce, and disposal will remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information. CFR citation: 40 CFR 721.11004. PMN Numbers: P-16-309 and P-16-310 Chemical names: 12-Hydroxystearic acid, reaction products with alkylene diamine and alkanoic acid (generic). [[Page 48641]] CAS numbers: Not available. Effective date of TSCA section 5(e) consent order: February 17, 2017. Basis for TSCA section 5(e) consent order: The PMN states that the PMN substances will be used as rheological or thixotropic agents used in the production of solvent based industrial coatings, high solid aromatic paints, adhesives, sealants, and other types of paints and topcoats. Based on submitted test data, EPA predicts blood and hematology effects. Further, based on SAR analysis of test data on analogous amides, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 2 ppb of the PMN substances in surface waters. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that the substances may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the consent order requires: (1) No domestic manufacture of the PMN substances. (2) No manufacture beyond the annual production volume specified in the consent order. (3) Use of the PMN substances only for the use specified in the consent order. (4) Compliance with the release to water provisions. Recommended testing: EPA has determined that the results of certain human health and environmental toxicity testing would help characterize the PMN substances. The submitter has agreed not to exceed the confidential production limit without performing a fish early-life stage toxicity test (OCSPP Test Guideline 850.1400), a daphnid chronic toxicity test (OCSPP Test Guideline 850.1300), and an algal toxicity test (OCSPP Test Guideline 850.1300). In addition, EPA has determined that the results of a repeated dose dermal toxicity test (OPPTS Test Guideline 870.3200) would help characterize the human health effects of the PMN substances. The Order's restrictions on manufacture, processing, distribution in commerce, and disposal will remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information. CFR citation: 40 CFR 721.11005. PMN Number: P-16-315 Chemical name: Alkyldiene, polymer, hydroxy terminated alkoxysilylalkylcarbamate (generic). CAS number: Not available. Effective date of TSCA section 5(e) consent order: January 17, 2017. Basis for TSCA section 5(e) consent order: The PMN states that the PMN substance will be used as an additive to improve the compatibility of the dispersibility of inorganic fillers in industrial rubber formulation. Based on physical/chemical properties, EPA predicts irritation and lung effects to unprotected workers from repeated inhalation and dermal exposures. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that the substance may present an unreasonable risk of injury to human health. To protect against these risks, the consent order requires: (1) No domestic manufacture of the PMN substance. (2) Use of the PMN substance only for the use specified in the consent order. Recommended testing: EPA has determined that a 90-day subchronic inhalation test in rodents (OCSPP Harmonized Test Guideline 870.3465); would help characterize possible health effects of the substance. Although the Order does not require this test, the Order's restrictions on manufacture, processing, distribution in commerce, and disposal will remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information. CFR citation: 40 CFR 721.11006. PMN Number: P-16-323 Chemical name: Alkylaldehyde, reaction products with substituted carbomonocycle-substituted heteromonocycle-alkylene glycol bis[[[[substituted(oxoneoalkyl)oxy]alkyl] amino]alkyl] ether polymer and alkyl substituted alkanediamine, acetate salts (generic). CAS number: Not available. Effective date of TSCA section 5(e) consent order: November 22, 2016. Basis for TSCA section 5(e) consent order: The PMN states that the PMN substance will be used as a coating resin. Based on test data on formaldehyde and analogous cationic polymers, EPA predicts sensitization, carcinogenicity, and lung effects to unprotected workers from repeated dermal exposures. Further, based on SAR analysis of test data on analogous cationic polymers, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 32 ppb of the PMN substance in surface waters. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the consent order requires: (1) No manufacture of the PMN such that residual formaldehyde is more than 0.1 weight percent of the PMN substance. (2) Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS. (3) Use of the PMN substance only for the use specified in the consent order. (4) No application method that generates a dust, mist, or aerosol. Recommended testing: EPA has determined that a 28-day subacute inhalation toxicity study (OECD 412), a fish acute toxicity test mitigated by humic acid (OCSPP Test Guideline 850.1085), an aquatic invertebrate, acute toxicity test, freshwater daphnids (OCSPP Test Guideline 850.1075), and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize possible health and environmental effects of the substance. Although the Order does not require these tests, the Order's restrictions on manufacture, processing, distribution in commerce, and disposal will remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information. CFR citation: 40 CFR 721.11007. PMN Numbers: P-16-330 and P-16-331 Chemical names: Hydroxy functional triglyceride polymer with glycerol mono-ester and 1,1'-methylenebis[4-isocyanatobenzene] (P-16- 330) and Hydroxy functional triglyceride polymer with glycerol mono- ester and 1,1'-methylenebis[isocyanatobenzene] (P-16-331) (generic) CAS numbers: Not available Effective date of TSCA section 5(e) consent order: February 14, 2017. Basis for TSCA section 5(e) consent order: The PMN states that the PMN substances will be used as industrial adhesives. Based on submitted test data, EPA predicts dermal sensitization, respiratory sensitization, and lung effects to unprotected workers from repeated inhalation and dermal exposures. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that the substances may present an unreasonable risk of injury to human health. To protect against these risks, the consent order requires: (1) Manufacture of the PMN substances to contain no more than 0.1% residual isocyanate by weight. (2) No sale of the PMN substances for ``consumer use'' or for ``commercial uses'' (as the term is defined in Sec. 721.3) when the ``saleable goods or service'' could introduce PMNs material into a [[Page 48642]] ``consumer'' setting (as that term is defined in Sec. 721.3). (3) Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS. Recommended testing: EPA has determined that a skin sensitization study (OPPTS 870.2600) and a 90-day inhalation study (OPPTS 870.3465) would help characterize possible health effects of the substances. Although the Order does not require these tests, the Order's restrictions on manufacture, processing, distribution in commerce, and disposal will remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information. CFR citations: 40 CFR 721.11008 (P-16-330) and 40 CFR 721.11009 (P- 16-331). PMN Number: P-16-360 Chemical name: Poly(oxy-1,2-ethanediyl),.alpha.-(1- oxodocosyl)-.omega.-[(1-oxodocosyl)oxy]-. CAS number: 36493-27-3. Effective date of TSCA section 5(e) consent order: December 12, 2016. Basis for TSCA section 5(e) consent order: The PMN states that the PMN substance will be used as a fuel additive. Based on physical/ chemical properties, EPA estimates the PMN substance would have low environmental hazard due to its poor water solubility. However, if the number of repeating ethylene oxide units in the polymer is large (i.e., greater than 10), the polymer would become a dispersible surfactant. Based on SAR analysis of test data on an analogous nonionic polymer, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 350 ppb of the PMN substance in surface waters. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that the substance may present an unreasonable risk of injury to the environment. To protect against these risks, the consent order requires manufacture such that no more than 33% of the PMN substance contains 10 or more repeating ethylene oxide units. Recommended testing: EPA has determined that an acute invertebrate toxicity test, freshwater daphnids (OCSPP Test Guideline 850.1010), a fish acute toxicity test, freshwater and marine (OCSPP Test Guideline 850.1075), a fish early-life stage toxicity test (OCSPP Test Guideline 850.1400), a daphnid chronic toxicity test (OCSPP Test Guideline 850.1300), and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize possible environmental effects of the substance. Although the Order does not require these tests, the Order's restrictions on manufacture, processing, distribution in commerce, and disposal will remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information. CFR citation: 40 CFR 721.11010. PMN Number: P-16-361 Chemical name: Pulp, cellulose, reaction products with lignin. CAS number: 1671062-70-6. Effective date of TSCA section 5(e) consent order: December 12, 2016. Basis for TSCA section 5(e) consent order: The PMN states that the PMN substance will be used as plastic reinforcement. Based on SAR analysis on structurally similar respirable poorly soluble particulates, EPA predicts pulmonary toxicity to unprotected workers from repeated inhalational exposures. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that the substance may present an unreasonable risk of injury to human health. To protect against these risks, the consent order requires: (1) Distribution of the PMN substance only in a liquid or gel formulation, unless the solid particle form has a particle size distribution where less than 0.5% of the particles are less than 10 microns. (2) No use in application methods that generate a dust, mist, or aerosol unless such application method occurs in an enclosed process. Recommended testing: EPA has determined that the results of physical/chemical characteristics would help characterize the PMN substance. The submitter has agreed not to manufacture beyond a certain time period without measuring the particle size distribution to characterize the particle size distribution of fractions less than 10 microns of the dry particle PMN substance. CFR citation: 40 CFR 721.11011. PMN Numbers: P-16-365 and P-16-367 Chemical names: Alkyl carbonate, polymer with, substituted alkanes and substituted heteromonocycle, substituted alkyl acrylate-blocked (generic) (P-16-365) and substituted heteromonocycle, polymer with substituted alkane and ethoxylated alkane, substituted heteromonocycle substituted alkyl ester-blocked (generic) (P-16-367). CAS numbers: Not available. Effective date of TSCA section 5(e) consent order: January 3, 2017. Basis for TSCA section 5(e) consent order: The PMN states that the PMN substances will be used as a UV curable coating resin for industrial use. Based on SAR analysis on structurally similar diisocyanates and acrylates, EPA predicts eye and skin irritation, dermal sensitization, respiratory sensitization, lung effects, mutagenicity, cancer, developmental, liver, and kidney toxicity to unprotected workers from repeated inhalation and dermal exposures. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that the substances may present an unreasonable risk of injury to human health. To protect against these risks, the consent order requires: (1) Use of personal protective equipment involving impervious gloves (where there is a potential for dermal exposure). (2) Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS. (3) No manufacture, process, or use of the substances as consumer products. (4) Manufacture of the PMN substances to contain no more than 0.1 residual isocyanate by weight. Recommended testing: EPA has determined that the results of a local lymph node assay (OPPTS 870.2600), a 90-day inhalation toxicity test with 60-day holding period (OPPTS 870.3465), and a two-year oral bioassay (OPPTS 870.4200) would help characterize possible health effects of the substances. Although the Order does not require these tests, the Order's restrictions on manufacture, processing, distribution in commerce, and disposal will remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information. CFR citations: 40 CFR 721.11012 (P-16-365) and 40 CFR 721.11013 (P- 16-367). PMN Number: P-16-369 Chemical name: Substituted heteromonocycle, telomer with substituted carbomonocycles, substituted alkyl ester (generic). CAS number: Not available. Effective date of TSCA section 5(e) consent order: January 23, 2017. Basis for TSCA section 5(e) consent order: The PMN states that the PMN substance will be used as a UV curable coating resin for industrial use. Based on SAR analysis on structurally similar acrylates and other chemicals, EPA predicts eye and skin irritation, dermal sensitization, respiratory sensitization, lung effects, mutagenicity, cancer, developmental toxicity, liver, and [[Page 48643]] kidney toxicity to unprotected workers from repeated inhalation and dermal exposures. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that the substance may present an unreasonable risk of injury to human health. To protect against these risks, the consent order requires: (1) Use of personal protective equipment involving impervious gloves and protective clothing (where there is a potential for dermal exposure) and a NIOSH-certified respirator with an APF of at least 50 (where there is a potential for inhalation exposure). (2) No manufacture, process, or use of the substance for use in a consumer product. (3) Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS. (4) Manufacture of the PMN substance to contain no more than 0.1 residual by weight of chemicals described in the 5(e) consent order. Recommended testing: EPA has determined that the results of certain human health toxicity testing would help characterize the PMN substance. The submitter has agreed not to exceed the confidential production limit without performing a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465 or OECD Test Guideline 413). In addition, EPA has determined that the results of a skin sensitization (OPPTS 870.2600), a local lymph node assay (OECD 429), and two-year bioassay (oral) (OPPTS 870.4200) would help characterize possible health effects of the substance. Although the Order does not require these tests, the Order's restrictions on manufacture, processing, distribution in commerce, and disposal will remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information. CFR citation: 40 CFR 721.11014. PMN Number: P-16-387 Chemical name: Aliphatic polycarboxylic acid, polymer with alicyclic polyhydric alcohol and polyoxyalkylene (generic). CAS number: Not available. Effective date of TSCA section 5(e) consent order: February 7, 2017. Basis for TSCA section 5(e) consent order: The PMN states that the PMN substance will be used as an additive for a polymer. Based on physical/chemical properties of the PMN substance, EPA predicts lung effects to unprotected workers from repeated exposures. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that the substance may present an unreasonable risk of injury to human health. To protect against these risks, the consent order requires: (1) Manufacture of the PMN substance such that the minimum average molecular weight is 18,000 daltons. (2) No processing or use in any manner or method that generates a dust, mist, or aerosol. (3) Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS. Recommended testing: EPA has determined that the results of a 90- day inhalation toxicity test with 30-day holding period (OPPTS 870.3465), a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD 422) an acute fish toxicity test (OCSPP 850.1075), an acute daphnia toxicity test (OCSPP 850.1300), and an algal toxicity test (OCSPP 850.4500) would help characterize possible health and environmental effects of the substance. Although the Order does not require these tests, the Order's restrictions on manufacture, processing, distribution in commerce, and disposal will remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information. CFR citation: 40 CFR 721.11015. PMN Number: P-16-398 Chemical name: Di-ammonium di-carboxylate (generic). CAS number: Not available. Effective date of TSCA section 5(e) consent order: November 14, 2016. Basis for TSCA section 5(e) consent order: The PMN states that the PMN substance will be used as a corrosion inhibitor. Based on test data on analogous anionic surfactants, EPA predicts eye and mucous membrane irritation and skin sensitization to unprotected workers from repeated dermal exposures. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that the substance may present an unreasonable risk of injury to human health. To protect against these risks, the consent order requires: 1. Use of personal protective equipment including impervious gloves and protective clothing to prevent dermal exposure. 2. Use of the PMN substance only for the use specified in the consent order. 3. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS. Recommended testing: EPA has determined that the results of certain human health toxicity testing would help characterize the effects of the PMN substance. The submitter has agreed not to exceed the confidential production limit without performing three skin sensitization studies (OECD 442B), (OECD 442C), and (OECD 442D). CFR citation: 40 CFR 721.11016. PMN Number: P-16-455 Chemical name: Sodium tungsten oxide. CAS number: Not available. Effective date of TSCA section 5(e) consent order: November 2, 2016. Basis for TSCA section 5(e) consent order: The PMN states that the PMN substance will be used as a component of infrared absorption material. Based on SAR analysis on structurally similar respirable poorly soluble particulates, EPA predicts pulmonary toxicity and carcinogenicity to unprotected workers from repeated inhalation exposures. Further, based on test data on analogous tungsten oxide, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substance in surface waters. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the consent order requires: 1. Use of personal protective equipment to prevent dermal exposure. 2. Use of a NIOSH-certified respirator with an APF of at least 1000 or compliance with a NCEL of 0.3 ppm as an 8-hour time-weighted average to prevent inhalation exposure. 3. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS. 4. Use of the PMN substance only for the use specified in the consent order. 5. No use in application methods that generate a dust, mist, or aerosol unless such application method occurs in an enclosed process. 6. No use of the PMN substance resulting in releases to surface waters and disposal of the PMN substance only by landfill or incineration. Recommended testing: EPA has determined that the results of certain human health toxicity testing would help characterize the PMN substance. The submitter has agreed not to exceed the confidential production limit without performing a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465 or OECD Test Guideline 413) [[Page 48644]] and a two- year inhalation bioassay test (OPPTS 870.4200). CFR citation: 40 CFR 721.11017. 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) consent order: January 11, 2017. Basis for TSCA section 5(e) consent order: The PMN states that the PMN substance will be used as a site-limited polymer intermediate for production of a deck stain coating resin additive. Based on physical/ chemical properties, EPA predicts low health hazard for the PMN substance when it is manufactured as described in the PMN. However, if the chemical substance is manufactured with a lower molecular weight and a higher proportion of the acid component (i.e., greater than 20%), the PMN substance could cause developmental effects in unprotected workers from repeated dermal and inhalation exposures. Further, based on physical/chemical properties, EPA predicts low hazard for the PMN substance when it is manufactured as described in the PMN due to low water solubility. However, if the chemical substance is manufactured with a higher proportion of the acid component (i.e., greater than 20%), there is potential for 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 the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the consent order requires: 1. Manufacture of the PMN substance to have an average molecular weight no less than 1500 daltons. 2. Manufacture of the PMN substance to have no more than 24% by weight of the acid component. 3. Use of the PMN substance only as intermediate. Recommended testing: EPA has determined that a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD 422), water solubility test, log Kow tests, a compositional/component analysis (certificate of analysis), a fish early-life stage toxicity test (OCSPP Test Guideline 850.1400), a daphnid chronic toxicity test (OCSPP Test Guideline 850.1300), fish acute toxicity mitigated by humic acid (OCSPP Test Guideline 850.1085), an aquatic invertebrate, acute toxicity test, freshwater daphnids (OCSPP Test Guideline 850.1075), and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the physical-chemical properties and possible health and environmental effects of the substance. Although the Order does not require these tests, the Order's restrictions on manufacture, processing, distribution in commerce, and disposal will remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information. CFR citation: 40 CFR 721.11018. PMN Number: P-16-591 Chemical name: Alkyl bisphenol (generic). CAS number: Not available. Effective date of TSCA section 5(e) consent order: January 9, 2017. Basis for TSCA section 5(e) consent order: The PMN states that the PMN substance will be used as a component of printing ink. Based on test data on bisphenol analogs, EPA predicts irritation to eyes, skin, lung, and mucous membranes; developmental, reproductive, liver and kidney toxicities; dermal sensitization; photosensitization; effects to the adrenals and other toxic effects associated with an endocrine disruption mode of action to unprotected workers from repeated dermal and inhalation exposures. Further, based on SAR analysis of test data on analogous phenols, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 2 ppb of the PMN substance in surface waters. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the consent order requires: 1. Use of personal protective equipment including impervious gloves and protective clothing to prevent dermal exposure and a NIOSH- certified respirator with an APF of at least 10 to prevent inhalation exposure. 2. Use of the PMN substance only for the use specified in the consent order. 3. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS. 4. No use of the PMN substance resulting in releases to surface waters. Recommended testing: EPA has determined that the results of certain human health and environmental toxicity testing would help characterize the PMN substance. The submitter has agreed not to exceed the confidential production limit without performing the reproduction/ developmental toxicity screening test (OECD 422). In addition, EPA has determined that the results of a fish early-life stage toxicity test (OCSPP Test Guideline 850.1400) and a daphnid chronic toxicity test (OCSPP Test Guideline 850.1300) would help characterize the environmental effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions on manufacture, processing, distribution in commerce, and disposal will remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information. CFR citation: 40 CFR 721.11019. 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 29 chemical substances, regulation was warranted under TSCA section 5(e), pending the development of information sufficient to make reasoned evaluations of the health or environmental effects of the chemical substances. The basis for such findings is outlined in Unit IV. Based on these findings, TSCA section 5(e) consent orders requiring the use of appropriate exposure controls were negotiated with the PMN submitters. The SNUR provisions for these chemical substances are consistent with the provisions of the TSCA section 5(e) consent orders. These SNURs are promulgated pursuant to Sec. 721.160 (see Unit VI.). 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 TSCA Chemical Substance Inventory (TSCA Inventory) 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 [[Page 48645]] described significant new use of the chemical substance occurs. EPA will ensure that all manufacturers and processors of the same chemical substance that is subject to a TSCA section 5(e) consent order are subject to similar requirements. Issuance of a SNUR for a chemical substance does not signify that the chemical substance is listed on the 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, as described in Sec. 721.160(c)(3). In accordance with Sec. 721.160(c)(3)(ii) the effective date of this rule is December 18, 2017 without further notice, unless EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments before November 20, 2017. If EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments, on one or more of these SNURs before November 20, 2017, EPA will withdraw the relevant sections of this direct final rule before its effective date. EPA will then issue a proposed SNUR for the chemical substance(s) on which adverse or critical comments were received, providing a 30-day period for public comment. This rule establishes SNURs for a number of chemical substances. Any person who submits adverse or critical comments, or notice of intent to submit adverse or critical comments, must identify the chemical substance and the new use to which it applies. EPA will not withdraw a SNUR for a chemical substance not identified in the comment. VII. Applicability of the Significant New Use Designation To establish a significant new use, EPA must determine that the use is not ongoing. The chemical substances subject to this rule have undergone premanufacture review. In cases where EPA has not received a notice of commencement (NOC) and the chemical substance has not been added to the TSCA Inventory, no person may commence such activities without first submitting a PMN. Therefore, for chemical substances for which an NOC has not been submitted EPA concludes that the designated significant new uses are not ongoing. When chemical substances identified in this rule are added to the TSCA Inventory, EPA recognizes that, before the rule is effective, other persons might engage in a use that has been identified as a significant new use. However, TSCA section 5(e) consent orders have been issued for these chemical substances, and the PMN submitters are prohibited by the TSCA section 5(e) consent orders from undertaking activities which would be designated as significant new uses. The identities of 19 of the 29 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). 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 July 10, 2017 (the date of public release/web posting of this rule) as the cutoff date for determining whether the new use is ongoing. This designation varies slightly from EPA's past practice of designating the date of Federal Register publication as the date for making this determination. The objective of EPA's approach has been to ensure that a person could not defeat a SNUR by initiating a significant new use before the effective date of the direct final rule. In developing this rule, EPA has recognized that, given EPA's practice of now posting rules on its Web site a week or more in advance of Federal Register publication, this objective could be thwarted even before that publication. Thus, EPA has slightly modified its approach in this rulemaking and plans to follow this modified approach in future significant new use rulemakings. Persons who begin commercial manufacture or processing of the chemical substances for a significant new use identified as of that date would have to cease any such activity upon the effective date of the final rule. To resume their activities, these persons would have to first comply with all applicable SNUR notification requirements and wait until the notice review period, including any extensions, expires. If such a person met the conditions of advance compliance under Sec. 721.45(h), the person would be considered exempt from the requirements of the SNUR. Consult the Federal Register document of April 24, 1990 for a more detailed discussion of the cutoff date for ongoing uses. 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: TSCA section 5(b)(1) requires development of test data where the chemical substance subject to the SNUR is also subject to a rule, order or consent agreement under TSCA section 4 (15 U.S.C. 2603). In the absence of a rule order, or consent agreement under TSCA section 4 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 Sec. 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. Unit IV. lists required or recommended testing for all of the listed SNURs. Descriptions of tests are provided for informational purposes. EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol selection. 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 the TSCA section 5(e) consent orders for the chemical substances regulated under this rule, EPA has established production volume limits in view of the lack of data on the potential health and environmental risks that may be posed by the significant new uses or increased exposure to the chemical substances. These limits cannot be exceeded unless the PMN submitter first submits the results of tests specified in the order that would permit a reasoned evaluation of the potential risks posed by these chemical substances. Under recent TSCA section 5(e) consent orders, each PMN submitter is required to submit each study at least 14 weeks (earlier TSCA section 5(e) consent orders required submissions at least 12 weeks) before reaching the specified production limit. Listings of the tests specified in the TSCA section 5(e) consent orders are included in Unit IV. The SNURs contain the same production volume limits as the TSCA section 5(e) consent orders. Exceeding these production limits is defined as a significant new use. Persons who intend [[Page 48646]] 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. The recommended tests specified in Unit IV. may not be the only means of addressing the potential risks of the chemical substance. However, submitting a SNUN without any test data may increase the likelihood that EPA will take action under TSCA section 5(e), particularly if satisfactory test results have not been obtained from a prior PMN or SNUN submitter. EPA recommends that potential SNUN submitters contact EPA early enough so that they will be able to conduct the appropriate tests. SNUN submitters should be aware that EPA will be better able to evaluate SNUNs which provide detailed information on the following: Human exposure and environmental release that may result from the significant new use of the chemical substances. Potential benefits 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 Sec. 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 Sec. Sec. 720.40 and 721.25. E-PMN software is available electronically at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca. 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-2017-0166. 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, or TSCA section 5(e) consent orders. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled ``Regulatory Planning and Review'' (58 FR 51735, October 4, 1993). B. Paperwork Reduction Act (PRA) According to PRA (44 U.S.C. 3501 et seq.), an agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR part 9, and included on the related collection instrument or form, if applicable. EPA is amending the table in 40 CFR part 9 to list the OMB approval number for the information collection requirements contained in this action. This listing of the OMB control numbers and their subsequent codification in the CFR satisfies the display requirements of PRA and OMB's implementing regulations at 5 CFR part 1320. This Information Collection Request (ICR) was previously subject to public notice and comment prior to OMB approval, and given the technical nature of the table, EPA finds that further notice and comment to amend it is unnecessary. As a result, EPA finds that there is ``good cause'' under section 553(b)(3)(B) of the Administrative Procedure Act (5 U.S.C. 553(b)(3)(B)) to amend this table without further notice and comment. The information collection requirements related to this action have already been approved by OMB pursuant to PRA under OMB control number 2070-0012 (EPA ICR No. 574). This action does not impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average between 30 and 170 hours per response. This burden estimate 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. 605(b)), that promulgation of a SNUR does not have a significant economic impact on a substantial number of small entities where the following are true: [[Page 48647]] 1. A significant number of SNUNs would not be submitted by small entities in response to the SNUR. 2. The SNUR submitted by any small entity would not cost significantly more than $8,300. A copy of that certification is available in the docket for this action. This action is within the scope of the February 18, 2012 certification. Based on the Economic Analysis discussed in Unit XI. and EPA's experience promulgating SNURs (discussed in the certification), EPA believes that the following are true: A significant number of SNUNs would not be submitted by small entities in response to the SNUR. Submission of the SNUN would not cost any small entity significantly more than $8,300. Therefore, the promulgation of the SNUR would not have a significant economic impact on a substantial number of small entities. D. Unfunded Mandates Reform Act (UMRA) Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or Tribal government will be impacted by this action. As such, EPA has determined that this action does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1502, 1503, 1504, or 1505 et seq.). E. Executive Order 13132 This action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 10, 1999). F. Executive Order 13175 This action does not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This action does not significantly nor uniquely affect the communities of Indian Tribal governments, nor does it involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175, entitled ``Consultation and Coordination with Indian Tribal Governments'' (65 FR 67249, November 9, 2000), do not apply to this action. G. Executive Order 13045 This action is not subject to Executive Order 13045, entitled ``Protection of Children from Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997), because this is not an economically significant regulatory action as defined by Executive Order 12866, and this action does not address environmental health or safety risks disproportionately affecting children. H. Executive Order 13211 This action is not subject to Executive Order 13211, entitled ``Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001), because this action is not expected to affect energy supply, distribution, or use and because this action is not a significant regulatory action under Executive Order 12866. I. National Technology Transfer and Advancement Act (NTTAA) In addition, since this action does not involve any technical standards, NTTAA section 12(d) (15 U.S.C. 272 note), does not apply to this action. J. Executive Order 12898 This action does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898, entitled ``Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations'' (59 FR 7629, February 16, 1994). XIII. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a ``major rule'' as defined by 5 U.S.C. 804(2). List of Subjects 40 CFR Part 9 Environmental protection, Reporting and recordkeeping requirements. 40 CFR Part 721 Environmental protection, Chemicals, Hazardous substances, Reporting and recordkeeping requirements. Dated: July 7, 2017. Maria J. Doa, Director, Chemical Control Division, Office of Pollution Prevention and Toxics. Therefore, 40 CFR parts 9 and 721 are amended as follows: PART 9--[AMENDED] 0 1. The authority citation for part 9 continues to read as follows: Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003, 2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330, 1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2, 300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542, 9601-9657, 11023, 11048. 0 2. In Sec. 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 * * * * * 721.10996............................................... 2070-0012 721.10997............................................... 2070-0012 721.10998............................................... 2070-0012 721.10999............................................... 2070-0012 721.11000............................................... 2070-0012 721.11001............................................... 2070-0012 721.11002............................................... 2070-0012 721.11003............................................... 2070-0012 721.11004............................................... 2070-0012 721.11005............................................... 2070-0012 721.11006............................................... 2070-0012 721.11007............................................... 2070-0012 721.11008............................................... 2070-0012 721.11009............................................... 2070-0012 721.11010............................................... 2070-0012 721.11011............................................... 2070-0012 721.11012............................................... 2070-0012 721.11013............................................... 2070-0012 721.11014............................................... 2070-0012 721.11015............................................... 2070-0012 721.11016............................................... 2070-0012 721.11017............................................... 2070-0012 721.11018............................................... 2070-0012 721.11019............................................... 2070-0012 * * * * * ------------------------------------------------------------------------ * * * * * [[Page 48648]] 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. 721.10996 to subpart E to read as follows: Sec. 721.10996 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1,2,4- benzenetricarboxylic acid, mixed decyl and octyl triesters (PMN P-15- 310) 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) and (3) and (b) (concentration set at 1.0 percent). (ii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(p) (2,440,000 kilograms), (s) (150,000 kilograms). It is a significant new use to use the PMN substance other than as a lubricant in chain oils for conveyor belts. (iii) Hazard communication program. A significant new use of the substance is any manner or method of manufacture or processing associated with any use of the substance without providing risk notification as follows: (A) If as a result of the test data required under the TSCA section 5(e) consent order for the substance, the employer becomes aware that the substance may present a risk of injury to human health or the environment, the employer must incorporate this new information, and any information on methods for protecting against such risk, into a MSDS as described in Sec. 721.72(c) within 90 days from the time the employer becomes aware of the new information. If the substance is not being manufactured, processed, or used in the employer's workplace, the employer must add the new information to a MSDS before the substance is reintroduced into the workplace. (B) The employer must ensure that persons who will receive the PMN substance from the employer, or who have received the PMN substance from the employer within 5 years from the date the employer becomes aware of the new information described in paragraph (a)(2)(iii)(A) of this section, are provided an MSDS containing the information required under paragraph (a)(2)(iii)(A) of this section within 90 days from the time the employer becomes aware of the new information. (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 (f) 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 5. Add Sec. 721.10997 to subpart E to read as follows: Sec. 721.10997 Multiwalled carbon nanotubes (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as multiwalled carbon nanotubes (PMN P-15-487/488/489/490/491) are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply when the PMN substances have been incorporated into a polymer matrix that has been reacted (cured) or embedded in a permanent solid polymer form that is not intended to undergo further processing except mechanical processing. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(2)(i) and (ii), (a)(3), (4), and (6) (particulate), and (c). 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. The following National Institute for Occupational Safety and Health (NIOSH)-certified respirators with an APF of at least 50 meet the requirements of Sec. 721.63(a)(4): (A) A NIOSH-certified air-purifying, tight-fitting full-face respirator equipped with N-100, P-100, or R-100 cartridges. (B) Any NIOSH-certified powered air-purifying respirator equipped with a tight-fitting full facepiece and equipped with HEPA filters. (C) Any NIOSH-certified negative pressure (demand) supplied-air respirator equipped with a full facepiece. (ii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(k) (additives for electro-static discharge in electronic devices, electronics, and materials; additives for weight reduction in materials; additives to improve mechanical properties or electrical conductivities; heat-generating elements in heating devices and materials; additives for heat transfer and thermal emissions in electronic devices and materials; semi-conductor, conductive, or resistive elements in electronic circuity and devices; additives to improve conductivity in electronic circuitry, energy storage systems, and devices; electron emitters for lighting and x-ray sources; additive for electromagnetic interface shielding in electronic devices; additives for electrodes in electronic materials and electronic devices; catalyst support in chemical manufacturing; coating additives to improve corrosion resistance of conductive properties; additives for fibers in structural and electrical applications; additives for fibers in fabrics and textiles; filter additives to remove nanoscale materials; semi-conducting compounding additives for high-voltage cable; and additives for super-hydrophobicity). A significant new use is any use involving an application method that generates a dust, mist or aerosol. (iii) Disposal. Requirements as specified in Sec. 721.85(a)(1) and (2), (b)(1) and (2), and (c)(1) and (2). (iv) Release to water. Requirements as specified in Sec. 721.90(a)(1), (b)(1), and (c)(1). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (e) and (i) through (k) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 6. Add Sec. 721.10998 to subpart E to read as follows: Sec. 721.10998 Propanoic acid, iron (2+) salt (2:1). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as propanoic acid, iron (2+) salt (2:1) (CAS #1952336-63-8) (PMN P-16-165) 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)(4) and (5) (particulate) and (b) (concentration set at 1.0 percent). [[Page 48649]] When determining which persons are reasonably likely to be exposed as required for Sec. 721.63(a)(4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. The following National Institute for Occupational Safety and Health (NIOSH)-certified respirators with an APF of at least 10 meet the requirements of Sec. 721.63(a)(4): (A) NIOSH-certified respirator with an N-100, P-100, or R-100 cartridge. (B) NIOSH-certified power air purifying respirator with a hood or helmet and with appropriate gas/vapor (acid gas, organic vapor, or substance specific) cartridges in combination with HEPA filters. (C) NIOSH-certified continuous flow supplied-air respirator equipped with a loose fitting facepiece, hood, or helmet. (ii) Hazard communication. Requirements as specified in Sec. 721.72(a) through (e) (concentration set at 1.0 percent), (f), (g)(1)(iv) and (ix), (g)(2)(ii), (iii), and (iv), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System (GHS) and OSHA Hazard Communication Standard may be used. (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(l), (p) (270,000 kilograms), (s) (5,000 kilograms). It is a significant new use to use the substance in formulations where the concentration is greater than 1 percent. (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 (d) and (f) through (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 7. Add Sec. 721.10999 to subpart E to read as follows: Sec. 721.10999 1-Butanaminium, N,N,N-tributyl-, carbonic acid (1:1). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1-butanaminium, N,N,N-tributyl-, carbonic acid (1:1) (PMN P-16-255; CAS No. 17351-62-1) 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) and (3) and (b) (concentration set at 1.0 percent). (ii) Hazard communication. Requirements as specified in Sec. 721.72(a) through (e) (concentration set at 1.0 percent), (f), (g)(1)(i) and (ii), (g)(2)(i), (ii), (iii), and (v), (g)(3)(i) and (ii), and (g)(5) and Notice to users: Minimize release to water. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System (GHS) and OSHA Hazard Communication Standard may be used. (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(p) (64,000 kilograms aggregate of P-16- 255, P-16-256, P-16-257, P-16-258, and P-16-259). It is a significant new use to manufacture, process, or use the substance other than as a blocked catalyst for paints and coatings. It is a significant new use to spray apply the PMN substance where the concentration of any combination of P-16-255, P-16-256, P-16-257, P-16-258, and P-16-259 in the final paint/coating formulation exceeds 1.5% by weight. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 8. Add Sec. 721.11000 to subpart E to read as follows: Sec. 721.11000 1-Butanaminium, N,N,N-tributyl-, methyl carbonate (1:1). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1-Butanaminium, N,N,N-tributyl-, methyl carbonate (1:1) (PMN P-16-256; CAS No. 56294- 05-2) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1) and (3) and (b) (concentration set at 1.0 percent). (ii) Hazard communication. Requirements as specified in Sec. 721.72(a) through (e) (concentration set at 1.0 percent), (f), (g)(1)(i) and (ii), (g)(2)(i), (ii), (iii), and (v), (g)(3)(i) and (ii), and (g)(5) and Notice to users: Minimize release to water. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System (GHS) and OSHA Hazard Communication Standard may be used. (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(p) (64,000 kilograms aggregate of P-16- 255, P-16-256, P-16-257, P-16-258, and P-16-259). It is a significant new use to manufacture, process, or use the substance other than as a blocked catalyst for paints and coatings. It is a significant new use to spray apply the PMN substance where the concentration of any combination of P-16-255, P-16-256, P-16-257, P-16-258, and P-16-259 in the final paint/coating formulation exceeds 1.5% by weight. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 9. Add Sec. 721.11001 to subpart E to read as follows: Sec. 721.11001 1-Butanaminium, N,N,N-tributyl-, ethyl carbonate (1:1). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1-butanaminium, N,N,N-tributyl-, ethyl carbonate (1:1) (PMN P-16-257; CAS No. 478796- 04-2) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1) and (3) and (b) (concentration set at 1.0 percent). (ii) Hazard communication. Requirements as specified in Sec. 721.72(a) through (e) (concentration set at 1.0 percent), (f), (g)(1)(i) and (ii), (g)(2)(i), (ii), (iii), and (v), (g)(3)(i) and (ii), and (g)(5) and Notice to users: Minimize release to water. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System (GHS) and OSHA Hazard Communication Standard may be used. (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(p)(64,000 kilograms aggregate of P-16-255, P-16-256, P-16-257, P-16-258, and P-16-259). It is a significant new use to [[Page 48650]] manufacture, process, or use the substance other than as a blocked catalyst for paints and coatings. It is a significant new use to spray apply the PMN substance where the concentration of any combination of P-16-255, P-16-256, P-16-257, P-16-258, and P-16-259 in the final paint/coating formulation exceeds 1.5% by weight. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 10. Add Sec. 721.11002 to subpart E to read as follows: Sec. 721.11002 1-Butanaminium, N,N,N-tributyl-, propyl carbonate (1:1). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1-butanaminium, N,N,N-tributyl-, propyl carbonate (1:1) (PMN P-16-258: CAS No. 1338579- 13-7) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1) and (3) and (b) (concentration set at 1.0 percent). (ii) Hazard communication. Requirements as specified in Sec. 721.72(a) through (e) (concentration set at 1.0 percent), (f), (g)(1)(i) and (ii), (g)(2)(i), (ii), (iii), and (v), (g)(3)(i) and (ii), and (g)(5) and Notice to users: Minimize release to water. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System (GHS) and OSHA Hazard Communication Standard may be used. (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(p) (64,000 kilograms aggregate of P-16- 255, P-16-256, P-16-257, P-16-258, and P-16-259). It is a significant new use to manufacture, process, or use the substance other than as a blocked catalyst for paints and coatings. It is a significant new use to spray apply the PMN substance where the concentration of any combination of P-16-255, P-16-256, P-16-257, P-16-258, and P-16-259 in the final paint/coating formulation exceeds 1.5% by weight. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 11. Add Sec. 721.11003 to subpart E to read as follows: Sec. 721.11003 1-Butanaminium, N,N,N-tributyl-, and 1-methylethyl carbonate. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1-butanaminium, N,N,N-tributyl-, and 1-methylethyl carbonate (PMN P-16-259; CAS No. 1803407-49-9) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1) and (3) and (b) (concentration set at 1.0 percent). (ii) Hazard communication. Requirements as specified in Sec. 721.72(a) through (e) (concentration set at 1.0 percent), (f), (g)(1)(i) and (ii), (g)(2)(i), (ii), (iii), and (v), (g)(3)(i) and (ii), (g)(4) (Notice to users: Minimize release to water), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System (GHS) and OSHA Hazard Communication Standard may be used. (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(p) (64,000 kilograms aggregate of P-16- 255, P-16-256, P-16-257, P-16-258, and P-16-259). It is a significant new use to manufacture, process, or use the substance other than as a blocked catalyst for paints and coatings. It is a significant new use to spray apply the PMN substance where the concentration of any combination of P-16-255, P-16-256, P-16-257, P-16-258, and P-16-259 in the final paint/coating formulation exceeds 1.5% by weight. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 12. Add Sec. 721.11004 to subpart E to read as follows: Sec. 721.11004 Anilino substituted bis-triazinyl derivative of 4,4'- diaminostilbene-2,2'-disulfonic acid, mixed amine sodium salt (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as anilino substituted bis-triazinyl derivative of 4,4'-diaminostilbene-2,2'- disulfonic acid, mixed amine sodium salt (PMN P-16-284) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(f). It is a significant new use to import or use the substance other than in a solution. It is a significant new use to use the substance other than as an optical brightener for textiles, paper, and paperboard. It is a significant new use to use the substance for non-industrial use or sell the substance for ``consumer use'' or for ``commercial uses'' (as the term is defined at Sec. 721.3) when the ``saleable goods or service'' could introduce the substance into a ``consumer'' setting (as that term is defined in Sec. 721.3). It is a significant new use to use the substance for an application method that generates a dust, mist, or aerosol unless the application method occurs in an enclosed process. (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 13. Add Sec. 721.11005 to subpart E to read as follows: Sec. 721.11005 12-Hydroxystearic acid, reaction products with alkylene diamine and alkanoic acid (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as 12- Hydroxystearic acid, reaction products with alkylene diamine and alkanoic acid (PMNs P-16-309 and P-16-310) are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. [[Page 48651]] (2) The significant new uses are: (i) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(f), (q), and (t). It is a significant new use to use the PMN substance other than as a rheological or thixotropic agent used in the production of solvent based industrial coatings, high solid aromatic paints, adhesives, sealants, and other types of paints and topcoats. (ii) Releases to water. Requirements as specified in Sec. 721.90(a)(4), (b)(4), and (c)(4) (N=2). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (c), (i), and (k) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of this section. 0 14. Add Sec. 721.11006 to subpart E to read as follows: Sec. 721.11006 Alkyldiene, polymer, hydroxy terminated alkoxysilylalkylcarbamate. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkyldiene, polymer, hydroxy terminated alkoxysilylalkylcarbamate (PMN P-16-315) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(f). It is a significant new use to process the substance in a manner that results in inhalation exposure. It is a significant new use to use the PMN substance other than as an additive to improve the compatibility and dispersibility of inorganic filler in industrial rubber formulations. (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 15. Add Sec. 721.11007 to subpart E to read as follows: Sec. 721.11007 Alkylaldehyde, reaction products with substituted carbomonocycle-substituted heteromonocycle-alkylene glycol bis[[[[substituted(oxoneoalkyl)oxy]alkyl] amino]alkyl] ether polymer and alkyl substituted alkanediamine, acetate salts (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkylaldehyde, reaction products with substituted carbomonocycle- substituted heteromonocycle-alkylene glycol bis[[[[substituted(oxoneoalkyl)oxy]alkyl] amino]alkyl] ether polymer and alkyl substituted alkanediamine, acetate salts (generic) (PMN P-16- 323) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Hazard communication. Requirements as specified in Sec. 721.72(a) through (e) (concentration set at 0.1 percent), (f), (g)(1) (respiratory tract irritation), (g)(1)(i) and (vii), (g)(2)(i), (ii), and (iii), (g)(3)(i) and (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(j). It is a significant new use to manufacture the PMN substance to contain a residual of formaldehyde greater than 0.1 weight percent. It is a significant new use to manufacture the substance in a manner that results in inhalation exposure. (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), (f), (g), and (h) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of this section. 0 16. Add Sec. 721.11008 to subpart E to read as follows: Sec. 721.11008 Hydroxy functional triglyceride polymer with glycerol mono-ester and 1,1'-methylenebis[4-isocyanatobenzene] (generic). (a) Chemical substances and significant new uses subject to reporting. (1) The chemical substance identified generically as hydroxy functional triglyceride polymer with glycerol mono-ester and 1,1'- methylenebis[4-isocyanatobenzene] (PMN P-16-330) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(2)(i), (iii), and (iv), (a)(3), and (b) (concentration set at 0.1 percent) (ii) Hazard communication. Requirements as specified in Sec. 721.72(a) through (e) (concentration set at 1.0 percent), (f), (g)(1)(i) and (ii), (g)(2)(i), (ii), (iii), and (v), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System (GHS) and OSHA Hazard Communication Standard may be used. (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80. It is a significant new use to manufacture the PMN substance to contain a residual of isocyanate greater than 0.1 weight percent. It is a significant new use to sell the substance for ``consumer use'' or for ``commercial uses'' (as the term is defined at Sec. 721.3) when the ``saleable goods or service'' could introduce the substance into a ``consumer'' setting (as that term is defined in Sec. 721.3). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 17. Add Sec. 721.11009 to subpart E to read as follows: Sec. 721.11009 Hydroxy functional triglyceride polymer with glycerol mono-ester and 1,1'-methylenebis[isocyanatobenzene] (generic). (a) Chemical substances and significant new uses subject to reporting. (1) The chemical substance identified generically as hydroxy functional triglyceride polymer with glycerol [[Page 48652]] mono-ester and 1,1'-methylenebis[isocyanatobenzene] (PMN P-16-331) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(2)(i), (iii), and (iv), (a)(3), and (b) (concentration set at 0.1 percent). (ii) Hazard communication. Requirements as specified in Sec. 721.72(a) through (e) (concentration set at 1.0 percent), (f), (g)(1)(i) and (ii), (g)(2)(i), (ii), (iii), and (v), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System (GHS) and OSHA Hazard Communication Standard may be used. (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80. It is a significant new use to manufacture the PMN substance to contain a residual of isocyanate greater than 0.1 weight percent. It is a significant new use to sell the substance for ``consumer use'' or for ``commercial uses'' (as the term is defined at Sec. 721.3) when the ``saleable goods or service'' could introduce the substance into a ``consumer'' setting (as that term is defined in Sec. 721.3). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 18. Add Sec. 721.11010 to subpart E to read as follows: Sec. 721.11010 Poly(oxy-1,2-ethanediyl),.alpha.-(1- oxodocosyl)-.omega.-[(1-oxodocosyl)oxy]- (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as poly(oxy-1,2-ethanediyl),.alpha.-(1-oxodocosyl)-.omega.-[(1- oxodocosyl)oxy]- (PMN P-16-360; CAS No. 36493-27-3) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80. It is a significant new use to manufacture the PMN substance such that more than 33% contains 10 or more repeating ethylene oxide units. (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 19. Add Sec. 721.11011 to subpart E to read as follows: Sec. 721.11011 Pulp, cellulose, reaction products with lignin. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as pulp, cellulose, reaction products with lignin (PMN P-16-361; CAS No. 167062- 70-6) 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) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(y)(1). It is a significant new use to manufacture, process, or use the PMN substance other than in a liquid or gel formulation, unless the solid particle form has a particle size distribution where less than 0.5% of the particles are less than 10 microns. It is a significant new use to manufacture the solid particle form more than six months without measuring the particle size distribution to characterize the particle size distribution of fractions less than 10 microns of the dry particle PMN substance and sending the results of the measurement to EPA. (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 20. Add Sec. 721.11012 to subpart E to read as follows: Sec. 721.11012 Alkyl carbonate, polymer with, substituted alkanes and substituted heteromonocycle, substituted alkyl acrylate-blocked (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkyl carbonate, polymer with, substituted alkanes and substituted heteromonocycle, substituted alkyl acrylate-blocked (generic) (PMN P- 16-365) 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) and (3) and (b) (concentration set at 0.1 percent). (ii) Hazard communication. Requirements as specified in Sec. 721.72(a) through (e) (concentration set at 0.1 percent), (f), (g)(1) (lung effects), (g)(1) (sensitization), (g)(1)(vii), (g)(2)(i), (ii), (iii), and (v), and (g)(5). (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80. It is a significant new use to manufacture the substance to contain a residual of isocyanate greater than 0.1 weight percent. It is a significant new use to sell the substance for ``consumer use'' or for ``commercial uses'' (as the term is defined at Sec. 721.3) when the ``saleable goods or service'' could introduce the substance into a ``consumer'' setting (as that term is defined in Sec. 721.3). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 21. Add Sec. 721.11013 to subpart E to read as follows: Sec. 721.11013 Substituted heteromonocycle, polymer with substituted alkane and ethoxylated alkane, substituted heteromonocycle substituted alkyl ester-blocked (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as substituted heteromonocycle, polymer with substituted alkane and ethoxylated alkane, substituted heteromonocycle [[Page 48653]] substituted alkyl ester-blocked (PMN P-16-367) 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) and (3) and (b) (concentration set at 0.1 percent). (ii) Hazard communication. Requirements as specified in Sec. 721.72(a) through (e) (concentration set at 0.1 percent), (f), (g)(1) (lung effects), (g)(1) (sensitization), (g)(1)(vii), (g)(2)(i), (ii), (iii), and (v), and (g)(5). (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80. It is a significant new use to manufacture the substance to contain a residual of isocyanate greater than 0.1 weight percent. It is a significant new use to sell the substance for ``consumer use'' or for ``commercial uses'' (as the term is defined at Sec. 721.3) when the ``saleable goods or service'' could introduce the substance into a ``consumer'' setting (as that term is defined in Sec. 721.3). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 22. Add Sec. 721.11014 to subpart E to read as follows: Sec. 721.11014 Substituted heteromonocycle, telomer with substituted carbomonocycles, substituted alkyl ester (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as substituted heteromonocycle, telomer with substituted carbomonocycles, substituted alkyl ester (PMN P-16-369) 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), (3), and (4), (a)(6) (particulate), (a)(6)(v) and (vi), and (b) (concentration set at 0.1 percent). The following National Institute for Occupational Safety and Health (NIOSH)-certified respirators with an APF of at least 50 meet the requirements of Sec. 721.63(a)(4): (A) Any NIOSH-certified air-purifying full facepiece respirator equipped with N100 (if oil aerosols absent), R-100, or P-100 filter(s). (B) Any NIOSH-certified powered air-purifying respirator equipped with a tight-fitting full facepiece and equipped with HEPA filters. (C) Any NIOSH-certified negative pressure (demand) supplied-air respirator equipped with a full facepiece. (D) Any NIOSH-certified continuous flow supplied-air respirator equipped with a tight-fitting full facepiece (half or full facepiece). (E) Any NIOSH-certified negative pressure (demand) self-contained breathing apparatus (SCBA) equipped with a hood or helmet or a full facepiece. (ii) Hazard communication. Requirements as specified in Sec. 721.72(a) through (e) (concentration set at 0.1 percent), (f), (g)(1) (lung effects), (g)(1) (sensitization), (g)(1)(vii), (g)(2)(i), (ii), (iii), and (v), and (g)(5). (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(q). It is a significant new use to manufacture the substance to contain residuals greater than 0.1 weight percent of chemicals described in the 5(e) consent order. It is a significant new use to sell the substance for ``consumer use'' or for ``commercial uses'' (as the term is defined at Sec. 721.3) when the ``saleable goods or service'' could introduce the substance into a ``consumer'' setting (as that term is defined in Sec. 721.3). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of this section. 0 23. Add Sec. 721.11015 to subpart E to read as follows: Sec. 721.11015 Aliphatic polycarboxylic acid, polymer with alicyclic polyhydric alcohol and polyoxyalkylene (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as aliphatic polycarboxylic acid, polymer with alicyclic polyhydric alcohol and polyoxyalkylene (PMN P-16-387) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Hazard communication. Requirements as specified in Sec. 721.72(a) through (e) (concentration set at 1.0 percent), (f), (g)(1)(ii), (g)(2)(ii), (g)(3)(i) and (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(y)(1) and (2). It is a significant new use to manufacture the substance with a molecular weight less than 18,000 daltons. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (c) and (f) through (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 0 24. Add Sec. 721.11016 to subpart E to read as follows: Sec. 721.11016 Di-ammonium di-carboxylate (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as di- ammonium di-carboxylate (PMN P-16-398) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(2)(i), (iii), and (iv), (a)(3), and (b) (concentration set at 1.0 percent). (ii) Hazard communication. Requirements as specified in Sec. 721.72(a) through (e) (concentration set at 1.0 percent), (f), (g)(1) (skin sensitization), (g)(1)(i), (g)(2)(i) and (v), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System (GHS) and [[Page 48654]] OSHA Hazard Communication Standard may be used. (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(j) and (q). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125(a) through (i) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of this section. 0 25. Add Sec. 721.11017 to subpart E to read as follows: Sec. 721.11017 Sodium tungsten oxide. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as sodium tungsten oxide (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 substance that 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), (3), (4), and (6) (particulate). The following National Institute for Occupational Safety and Health (NIOSH)-certified respirators with an APF of at least 1000 meet the requirements of Sec. 721.63(a)(4): (A) Any NIOSH-certified powered air purifying full facepiece respirator equipped with appropriate gas/vapor (acid gas, organic vapor, or substance specific) cartridges. (B) Any NIOSH-certified continuous flow supplied-air respirator equipped with a full facepiece. (C) Any NIOSH-certified pressure-demand or other positive pressure mode supplied-air respirator equipped with a full facepiece. (D) Any NIOSH-certified continuous flow supplied-air respirator equipped with a full facepiece. (E) Any NIOSH-certified pressure-demand or other positive pressure mode supplied-air respirator equipped with a full facepiece. (1) As an alternative to the respiratory requirements listed here, a manufacturer or processor may choose to follow the New Chemical Exposure Limit (NCEL) provisions listed in the TSCA section 5(e) consent order for this substance. The NCEL is 0.3 mg/m\3\ as an 8-hour time weighted average verified by actual monitoring data. (2) [Reserved]. (ii) Hazard communication. Requirements as specified in Sec. 721.72(a) through (e) (concentration set at 0.1 percent), (f), (g)(1) (lung effects), (g)(1)(vii), (g)(2)(ii), (iii), and (iv), (g)(3)(ii), (g)(4)(i) and (iii), and (g)(5). (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(q). It is a significant new use to use the PMN substance other than as a component of infrared absorption material. It is a significant new use for any application method that generates a dust, mist, or aerosol, unless such application method occurs in an enclosed process. (iv) Disposal. Requirements as specified in Sec. 721.85(a)(1) and (2), (b)(1) and (2), and (c)(1) and (2). (v) Releases 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 (k) are applicable to manufacturers and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of this section. 0 26. Add Sec. 721.11018 to subpart E to read as follows: Sec. 721.11018 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. The requirements of this section do not apply to quantities of the PMN substance that have been completely reacted (cured). (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 to have an average molecular weight less than 1500 daltons. It is a significant new use to manufacture the substance to have more than 24% by weight of the acid component identified in the 5(e) consent order. (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. (3) Determining whether a specific use is subject to this section. The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of this section. 0 27. Add Sec. 721.11019 to subpart E to read as follows: Sec. 721.11019 Alkyl bisphenol (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkyl bisphenol (PMN P-16-591) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63(a)(1), (a)(2)(i), (ii), and (iv), (a)(3) and (4), (a)(6)(v) and (vi), (a)(6) (particulate), and (b) (concentration set at 1.0 percent). When determining which persons are reasonably likely to be exposed as required for Sec. 721.63(a)(4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. The following National Institute for Occupational Safety and Health (NIOSH)-certified respirators with an APF of at least 10 meet the requirements of Sec. 721.63(a)(4): (A) NIOSH-certified respirator with an N-100, P-100, or R-100 cartridge. (B) NIOSH-certified power air purifying respirator with a hood or helmet and with appropriate gas/vapor (acid gas, organic vapor, or substance specific) cartridges in combination with HEPA filters. [[Page 48655]] (C) NIOSH-certified continuous flow supplied-air respirator equipped with a loose fitting facepiece, hood, or helmet. (ii) Hazard communication. Requirements as specified in Sec. 721.72(a) through (e) (concentration set at 0.1 percent), (f), (g)(1) (dermal sensitization), (g)(1) (endocrine disruption), (g)(1) (reproductive effects), (g)(1)(i), (ii), (iv), and (ix), (g)(2)(i), (ii), (iii), (iv), and (v), (g)(3)(i) and (ii), (g)(4)(iii), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System (GHS) and OSHA Hazard Communication Standard may be used. (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(q). It is a significant new use to use the PMN substance in thermal paper printing (iv) Releases 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)(ii) of this section. Editorial note: This document was received for publication by the Office of the Federal Register on October 10, 2017. [FR Doc. 2017-22239 Filed 10-18-17; 8:45 am] BILLING CODE 6560-50-P
![Federal Register / Vol. 82, No. 201 / Thursday, October 19, 2017 / Rules and Regulations 48637
Global Expedited Package Services Global eCommerce Marketplace (GeM) I.A., VI., and VII. of the SUPPLEMENTARY
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Outbound Competitive International [FR Doc. 2017–22645 Filed 10–18–17; 8:45 am]
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Operators 1 1404; email address: TSCA-Hotline@
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Special Services *
has conducted a review of the notice,
Address Enhancement Services SUPPLEMENTARY INFORMATION:
Greeting Cards, Gift Cards, and Stationery made an appropriate determination on
International Ancillary Services the notice, and has taken such actions I. General Information
International Money Transfer Service— as are required with that determination.
Outbound DATES: This rule is effective on
A. Does this action apply to me?
International Money Transfer Service— December 18, 2017. For purposes of You may be potentially affected by
Inbound judicial review, this rule shall be this action if you manufacture, process,
Premium Forwarding Service promulgated at 1 p.m. (e.s.t.) on or use the chemical substances
Shipping and Mailing Supplies
November 2, 2017. contained in this rule. The following list
Post Office Box Service
Competitive Ancillary Services Written adverse or critical comments, of North American Industrial
Nonpostal Services * or notice of intent to submit adverse or Classification System (NAICS) codes is
Advertising critical comments, on one or more of not intended to be exhaustive, but rather
Licensing of Intellectual Property other these SNURs must be received on or provides a guide to help readers
than Officially Licensed Retail Products before November 20, 2017 (see Unit VI. determine whether this document
(OLRP) of the SUPPLEMENTARY INFORMATION). If applies to them. Potentially affected
Mail Service Promotion EPA receives written adverse or critical entities may include:
Officially Licensed Retail Products (OLRP) comments, or notice of intent to submit • Manufacturers or processors of one
Passport Photo Service
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adverse or critical comments, on one or or more subject chemical substances
Photocopying Service
more of these SNURs before November (NAICS codes 325 and 324110), e.g.,
Rental, Leasing, Licensing or other Non-
Sale Disposition of Tangible Property 20, 2017, EPA will withdraw the chemical manufacturing and petroleum
Training Facilities and Related Services relevant sections of this direct final rule refineries.
USPS Electronic Postmark (EPM) Program before its effective date. This action may also affect certain
Market Tests * For additional information on related entities through pre-existing import
Customized Delivery reporting requirement dates, see Units certification and export notification
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CAS numbers: Not available. Basis for TSCA section 5(e) consent (1) No manufacture of the PMN such
Effective date of TSCA section 5(e) order: The PMN states that the PMN that residual formaldehyde is more than
consent order: February 17, 2017. substance will be used as an additive to 0.1 weight percent of the PMN
Basis for TSCA section 5(e) consent improve the compatibility of the substance.
order: The PMN states that the PMN dispersibility of inorganic fillers in (2) Establishment and use of a hazard
substances will be used as rheological or industrial rubber formulation. Based on communication program, including
thixotropic agents used in the physical/chemical properties, EPA human health precautionary statements
production of solvent based industrial predicts irritation and lung effects to on each label and in the SDS.
coatings, high solid aromatic paints, unprotected workers from repeated (3) Use of the PMN substance only for
adhesives, sealants, and other types of inhalation and dermal exposures. The the use specified in the consent order.
paints and topcoats. Based on submitted Order was issued under TSCA sections (4) No application method that
test data, EPA predicts blood and 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), generates a dust, mist, or aerosol.
hematology effects. Further, based on based on a finding that the substance Recommended testing: EPA has
SAR analysis of test data on analogous may present an unreasonable risk of determined that a 28-day subacute
amides, EPA predicts toxicity to aquatic injury to human health. To protect inhalation toxicity study (OECD 412), a
organisms may occur at concentrations against these risks, the consent order fish acute toxicity test mitigated by
that exceed 2 ppb of the PMN requires: humic acid (OCSPP Test Guideline
substances in surface waters. The Order (1) No domestic manufacture of the 850.1085), an aquatic invertebrate, acute
was issued under TSCA sections PMN substance. toxicity test, freshwater daphnids
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), (2) Use of the PMN substance only for (OCSPP Test Guideline 850.1075), and
based on a finding that the substances the use specified in the consent order. an algal toxicity test (OCSPP Test
may present an unreasonable risk of Recommended testing: EPA has Guideline 850.4500) would help
injury to human health and the determined that a 90-day subchronic characterize possible health and
environment. To protect against these inhalation test in rodents (OCSPP environmental effects of the substance.
risks, the consent order requires: Harmonized Test Guideline 870.3465); Although the Order does not require
(1) No domestic manufacture of the would help characterize possible health these tests, the Order’s restrictions on
PMN substances. effects of the substance. Although the manufacture, processing, distribution in
(2) No manufacture beyond the Order does not require this test, the commerce, and disposal will remain in
annual production volume specified in Order’s restrictions on manufacture, effect until the Order is modified or
the consent order. processing, distribution in commerce, revoked by EPA based on submission of
(3) Use of the PMN substances only and disposal will remain in effect until this or other relevant information.
for the use specified in the consent the Order is modified or revoked by CFR citation: 40 CFR 721.11007.
order. EPA based on submission of this or
other relevant information. PMN Numbers: P–16–330 and P–16–331
(4) Compliance with the release to
CFR citation: 40 CFR 721.11006. Chemical names: Hydroxy functional
water provisions.
Recommended testing: EPA has PMN Number: P–16–323 triglyceride polymer with glycerol
determined that the results of certain Chemical name: Alkylaldehyde, mono-ester and 1,1′-methylenebis[4-
human health and environmental reaction products with substituted isocyanatobenzene] (P–16–330) and
toxicity testing would help characterize carbomonocycle-substituted Hydroxy functional triglyceride polymer
the PMN substances. The submitter has heteromonocycle-alkylene glycol with glycerol mono-ester and 1,1′-
agreed not to exceed the confidential bis[[[[substituted(oxoneoalkyl)oxy]alkyl] methylenebis[isocyanatobenzene] (P–
production limit without performing a amino]alkyl] ether polymer and alkyl 16–331) (generic)
fish early-life stage toxicity test (OCSPP substituted alkanediamine, acetate salts CAS numbers: Not available
Test Guideline 850.1400), a daphnid (generic). Effective date of TSCA section 5(e)
chronic toxicity test (OCSPP Test CAS number: Not available. consent order: February 14, 2017.
Guideline 850.1300), and an algal Effective date of TSCA section 5(e) Basis for TSCA section 5(e) consent
toxicity test (OCSPP Test Guideline consent order: November 22, 2016. order: The PMN states that the PMN
850.1300). In addition, EPA has Basis for TSCA section 5(e) consent substances will be used as industrial
determined that the results of a repeated order: The PMN states that the PMN adhesives. Based on submitted test data,
dose dermal toxicity test (OPPTS Test substance will be used as a coating EPA predicts dermal sensitization,
Guideline 870.3200) would help resin. Based on test data on respiratory sensitization, and lung
characterize the human health effects of formaldehyde and analogous cationic effects to unprotected workers from
the PMN substances. The Order’s polymers, EPA predicts sensitization, repeated inhalation and dermal
restrictions on manufacture, processing, carcinogenicity, and lung effects to exposures. The Order was issued under
distribution in commerce, and disposal unprotected workers from repeated TSCA sections 5(a)(3)(B)(ii)(I) and
will remain in effect until the Order is dermal exposures. Further, based on 5(e)(1)(A)(ii)(I), based on a finding that
modified or revoked by EPA based on SAR analysis of test data on analogous the substances may present an
submission of this or other relevant cationic polymers, EPA predicts toxicity unreasonable risk of injury to human
information. to aquatic organisms may occur at health. To protect against these risks,
CFR citation: 40 CFR 721.11005. concentrations that exceed 32 ppb of the the consent order requires:
PMN substance in surface waters. The (1) Manufacture of the PMN
PMN Number: P–16–315
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Order was issued under TSCA sections substances to contain no more than
Chemical name: Alkyldiene, polymer, 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), 0.1% residual isocyanate by weight.
hydroxy terminated based on a finding that the substance (2) No sale of the PMN substances for
alkoxysilylalkylcarbamate (generic). may present an unreasonable risk of ‘‘consumer use’’ or for ‘‘commercial
CAS number: Not available. injury to human health and the uses’’ (as the term is defined in § 721.3)
Effective date of TSCA section 5(e) environment. To protect against these when the ‘‘saleable goods or service’’
consent order: January 17, 2017. risks, the consent order requires: could introduce PMNs material into a
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‘‘consumer’’ setting (as that term is possible environmental effects of the Basis for TSCA section 5(e) consent
defined in § 721.3). substance. Although the Order does not order: The PMN states that the PMN
(3) Establishment and use of a hazard require these tests, the Order’s substances will be used as a UV curable
communication program, including restrictions on manufacture, processing, coating resin for industrial use. Based
human health precautionary statements distribution in commerce, and disposal on SAR analysis on structurally similar
on each label and in the SDS. will remain in effect until the Order is diisocyanates and acrylates, EPA
Recommended testing: EPA has modified or revoked by EPA based on predicts eye and skin irritation, dermal
determined that a skin sensitization submission of this or other relevant sensitization, respiratory sensitization,
study (OPPTS 870.2600) and a 90-day information. lung effects, mutagenicity, cancer,
inhalation study (OPPTS 870.3465) CFR citation: 40 CFR 721.11010. developmental, liver, and kidney
would help characterize possible health toxicity to unprotected workers from
effects of the substances. Although the PMN Number: P–16–361
repeated inhalation and dermal
Order does not require these tests, the Chemical name: Pulp, cellulose, exposures. The Order was issued under
Order’s restrictions on manufacture, reaction products with lignin. TSCA sections 5(a)(3)(B)(ii)(I) and
processing, distribution in commerce, CAS number: 1671062–70–6. 5(e)(1)(A)(ii)(I), based on a finding that
and disposal will remain in effect until Effective date of TSCA section 5(e) the substances may present an
the Order is modified or revoked by consent order: December 12, 2016. unreasonable risk of injury to human
EPA based on submission of this or Basis for TSCA section 5(e) consent health. To protect against these risks,
other relevant information. order: The PMN states that the PMN the consent order requires:
CFR citations: 40 CFR 721.11008 (P– substance will be used as plastic (1) Use of personal protective
16–330) and 40 CFR 721.11009 (P–16– reinforcement. Based on SAR analysis equipment involving impervious gloves
331). on structurally similar respirable poorly (where there is a potential for dermal
soluble particulates, EPA predicts exposure).
PMN Number: P–16–360 pulmonary toxicity to unprotected (2) Establishment and use of a hazard
Chemical name: Poly(oxy-1,2- workers from repeated inhalational communication program, including
ethanediyl),.alpha.-(1-oxodocosyl)- exposures. The Order was issued under human health precautionary statements
.omega.-[(1-oxodocosyl)oxy]-. TSCA sections 5(a)(3)(B)(ii)(I) and on each label and in the SDS.
CAS number: 36493–27–3. 5(e)(1)(A)(ii)(I), based on a finding that (3) No manufacture, process, or use of
Effective date of TSCA section 5(e) the substance may present an the substances as consumer products.
consent order: December 12, 2016. unreasonable risk of injury to human (4) Manufacture of the PMN
Basis for TSCA section 5(e) consent health. To protect against these risks, substances to contain no more than 0.1
order: The PMN states that the PMN the consent order requires: residual isocyanate by weight.
substance will be used as a fuel (1) Distribution of the PMN substance Recommended testing: EPA has
additive. Based on physical/chemical only in a liquid or gel formulation, determined that the results of a local
properties, EPA estimates the PMN unless the solid particle form has a lymph node assay (OPPTS 870.2600), a
substance would have low particle size distribution where less 90-day inhalation toxicity test with 60-
environmental hazard due to its poor than 0.5% of the particles are less than day holding period (OPPTS 870.3465),
water solubility. However, if the number 10 microns. and a two-year oral bioassay (OPPTS
of repeating ethylene oxide units in the (2) No use in application methods that 870.4200) would help characterize
polymer is large (i.e., greater than 10), generate a dust, mist, or aerosol unless possible health effects of the substances.
the polymer would become a dispersible such application method occurs in an Although the Order does not require
surfactant. Based on SAR analysis of test enclosed process. these tests, the Order’s restrictions on
data on an analogous nonionic polymer, Recommended testing: EPA has manufacture, processing, distribution in
EPA predicts toxicity to aquatic determined that the results of physical/ commerce, and disposal will remain in
organisms may occur at concentrations chemical characteristics would help effect until the Order is modified or
that exceed 350 ppb of the PMN characterize the PMN substance. The revoked by EPA based on submission of
substance in surface waters. The Order submitter has agreed not to manufacture this or other relevant information.
was issued under TSCA sections beyond a certain time period without CFR citations: 40 CFR 721.11012 (P–
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), measuring the particle size distribution 16–365) and 40 CFR 721.11013 (P–16–
based on a finding that the substance to characterize the particle size 367).
may present an unreasonable risk of distribution of fractions less than 10
injury to the environment. To protect microns of the dry particle PMN PMN Number: P–16–369
against these risks, the consent order substance. Chemical name: Substituted
requires manufacture such that no more CFR citation: 40 CFR 721.11011. heteromonocycle, telomer with
than 33% of the PMN substance substituted carbomonocycles,
contains 10 or more repeating ethylene PMN Numbers: P–16–365 and P–16–367
substituted alkyl ester (generic).
oxide units. Chemical names: Alkyl carbonate, CAS number: Not available.
Recommended testing: EPA has polymer with, substituted alkanes and Effective date of TSCA section 5(e)
determined that an acute invertebrate substituted heteromonocycle, consent order: January 23, 2017.
toxicity test, freshwater daphnids substituted alkyl acrylate-blocked Basis for TSCA section 5(e) consent
(OCSPP Test Guideline 850.1010), a fish (generic) (P–16–365) and substituted order: The PMN states that the PMN
acute toxicity test, freshwater and heteromonocycle, polymer with substance will be used as a UV curable
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marine (OCSPP Test Guideline substituted alkane and ethoxylated coating resin for industrial use. Based
850.1075), a fish early-life stage toxicity alkane, substituted heteromonocycle on SAR analysis on structurally similar
test (OCSPP Test Guideline 850.1400), a substituted alkyl ester-blocked (generic) acrylates and other chemicals, EPA
daphnid chronic toxicity test (OCSPP (P–16–367). predicts eye and skin irritation, dermal
Test Guideline 850.1300), and an algal CAS numbers: Not available. sensitization, respiratory sensitization,
toxicity test (OCSPP Test Guideline Effective date of TSCA section 5(e) lung effects, mutagenicity, cancer,
850.4500) would help characterize consent order: January 3, 2017. developmental toxicity, liver, and
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1. A significant number of SNUNs 67249, November 9, 2000), do not apply Dated: July 7, 2017.
would not be submitted by small to this action. Maria J. Doa,
entities in response to the SNUR. Director, Chemical Control Division, Office
2. The SNUR submitted by any small G. Executive Order 13045
of Pollution Prevention and Toxics.
entity would not cost significantly more This action is not subject to Executive Therefore, 40 CFR parts 9 and 721 are
than $8,300. Order 13045, entitled ‘‘Protection of amended as follows:
A copy of that certification is Children from Environmental Health
available in the docket for this action. Risks and Safety Risks’’ (62 FR 19885, PART 9—[AMENDED]
This action is within the scope of the April 23, 1997), because this is not an
February 18, 2012 certification. Based economically significant regulatory ■ 1. The authority citation for part 9
on the Economic Analysis discussed in action as defined by Executive Order continues to read as follows:
Unit XI. and EPA’s experience 12866, and this action does not address Authority: 7 U.S.C. 135 et seq., 136–136y;
promulgating SNURs (discussed in the environmental health or safety risks 15 U.S.C. 2001, 2003, 2005, 2006, 2601–2671;
certification), EPA believes that the disproportionately affecting children. 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33
following are true: U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318,
• A significant number of SNUNs H. Executive Order 13211 1321, 1326, 1330, 1342, 1344, 1345 (d) and
would not be submitted by small (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,
entities in response to the SNUR. This action is not subject to Executive 1971–1975 Comp. p. 973; 42 U.S.C. 241,
• Submission of the SNUN would not Order 13211, entitled ‘‘Actions 242b, 243, 246, 300f, 300g, 300g–1, 300g–2,
cost any small entity significantly more Concerning Regulations That 300g–3, 300g–4, 300g–5, 300g–6, 300j–1,
than $8,300. Significantly Affect Energy Supply, 300j–2, 300j–3, 300j–4, 300j–9, 1857 et seq.,
Therefore, the promulgation of the Distribution, or Use’’ (66 FR 28355, May 6901–6992k, 7401–7671q, 7542, 9601–9657,
22, 2001), because this action is not 11023, 11048.
SNUR would not have a significant
economic impact on a substantial expected to affect energy supply, ■ 2. In § 9.1, add the following sections
number of small entities. distribution, or use and because this in numerical order under the
action is not a significant regulatory undesignated center heading
D. Unfunded Mandates Reform Act action under Executive Order 12866. ‘‘Significant New Uses of Chemical
(UMRA) Substances’’ to read as follows:
I. National Technology Transfer and
Based on EPA’s experience with
Advancement Act (NTTAA) § 9.1 OMB approvals under the Paperwork
proposing and finalizing SNURs, State,
Reduction Act.
local, and Tribal governments have not In addition, since this action does not
been impacted by these rulemakings, * * * * *
involve any technical standards,
and EPA does not have any reasons to NTTAA section 12(d) (15 U.S.C. 272 OMB
believe that any State, local, or Tribal note), does not apply to this action. 40 CFR citation control No.
government will be impacted by this
action. As such, EPA has determined J. Executive Order 12898
that this action does not impose any * * * * *
This action does not entail special
enforceable duty, contain any unfunded
considerations of environmental justice Significant New Uses of Chemical
mandate, or otherwise have any effect
related issues as delineated by Substances
on small governments subject to the
Executive Order 12898, entitled
requirements of UMRA sections 202,
‘‘Federal Actions to Address * * * * *
203, 204, or 205 (2 U.S.C. 1502, 1503,
Environmental Justice in Minority
1504, or 1505 et seq.). 721.10996 ............................. 2070–0012
Populations and Low-Income
E. Executive Order 13132 Populations’’ (59 FR 7629, February 16, 721.10997 ............................. 2070–0012
1994). 721.10998 ............................. 2070–0012
This action will not have a substantial 721.10999 ............................. 2070–0012
direct effect on States, on the XIII. Congressional Review Act 721.11000 ............................. 2070–0012
relationship between the national 721.11001 ............................. 2070–0012
government and the States, or on the Pursuant to the Congressional Review 721.11002 ............................. 2070–0012
distribution of power and Act (5 U.S.C. 801 et seq.), EPA will 721.11003 ............................. 2070–0012
responsibilities among the various submit a report containing this rule and 721.11004 ............................. 2070–0012
other required information to the U.S. 721.11005 ............................. 2070–0012
levels of government, as specified in
Senate, the U.S. House of 721.11006 ............................. 2070–0012
Executive Order 13132, entitled 721.11007 ............................. 2070–0012
‘‘Federalism’’ (64 FR 43255, August 10, Representatives, and the Comptroller 721.11008 ............................. 2070–0012
1999). General of the United States prior to 721.11009 ............................. 2070–0012
publication of the rule in the Federal 721.11010 ............................. 2070–0012
F. Executive Order 13175 Register. This action is not a ‘‘major 721.11011 ............................. 2070–0012
This action does not have Tribal rule’’ as defined by 5 U.S.C. 804(2). 721.11012 ............................. 2070–0012
implications because it is not expected 721.11013 ............................. 2070–0012
List of Subjects 721.11014 ............................. 2070–0012
to have substantial direct effects on
Indian Tribes. This action does not 40 CFR Part 9 721.11015 ............................. 2070–0012
significantly nor uniquely affect the 721.11016 ............................. 2070–0012
Environmental protection, Reporting 721.11017 ............................. 2070–0012
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communities of Indian Tribal 721.11018 ............................. 2070–0012
governments, nor does it involve or and recordkeeping requirements.
721.11019 ............................. 2070–0012
impose any requirements that affect 40 CFR Part 721
Indian Tribes. Accordingly, the * * * * *
requirements of Executive Order 13175, Environmental protection, Chemicals,
entitled ‘‘Consultation and Coordination Hazardous substances, Reporting and
with Indian Tribal Governments’’ (65 FR recordkeeping requirements. * * * * *
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PART 721—[AMENDED] (b) Specific requirements. The devices, electronics, and materials;
provisions of subpart A of this part additives for weight reduction in
■ 3. The authority citation for part 721 apply to this section except as modified materials; additives to improve
continues to read as follows: by this paragraph (b). mechanical properties or electrical
Authority: 15 U.S.C. 2604, 2607, and (1) Recordkeeping. Recordkeeping conductivities; heat-generating elements
2625(c). requirements as specified in in heating devices and materials;
■ 4. Add § 721.10996 to subpart E to § 721.125(a) through (f) and (i) are additives for heat transfer and thermal
read as follows: applicable to manufacturers and emissions in electronic devices and
processors of this substance. materials; semi-conductor, conductive,
§ 721.10996 1,2,4-Benzenetricarboxylic (2) Limitations or revocation of or resistive elements in electronic
acid, mixed decyl and octyl triesters. certain notification requirements. The circuity and devices; additives to
(a) Chemical substance and provisions of § 721.185 apply to this improve conductivity in electronic
significant new uses subject to reporting. section. circuitry, energy storage systems, and
(1) The chemical substance identified as ■ 5. Add § 721.10997 to subpart E to devices; electron emitters for lighting
1,2,4-benzenetricarboxylic acid, mixed read as follows: and x-ray sources; additive for
decyl and octyl triesters (PMN P–15– electromagnetic interface shielding in
310) is subject to reporting under this § 721.10997 Multiwalled carbon nanotubes
electronic devices; additives for
section for the significant new uses (generic).
electrodes in electronic materials and
described in paragraph (a)(2) of this (a) Chemical substance and electronic devices; catalyst support in
section. significant new uses subject to reporting. chemical manufacturing; coating
(2) The significant new uses are: (1) The chemical substances identified additives to improve corrosion
(i) Protection in the workplace. generically as multiwalled carbon resistance of conductive properties;
Requirements as specified in nanotubes (PMN P–15–487/488/489/ additives for fibers in structural and
§ 721.63(a)(1) and (3) and (b) 490/491) are subject to reporting under electrical applications; additives for
(concentration set at 1.0 percent). this section for the significant new uses
(ii) Industrial, commercial, and fibers in fabrics and textiles; filter
described in paragraph (a)(2) of this additives to remove nanoscale materials;
consumer activities. Requirements as section. The requirements of this section
specified in § 721.80(p) (2,440,000 semi-conducting compounding
do not apply when the PMN substances additives for high-voltage cable; and
kilograms), (s) (150,000 kilograms). It is have been incorporated into a polymer
a significant new use to use the PMN additives for super-hydrophobicity). A
matrix that has been reacted (cured) or significant new use is any use involving
substance other than as a lubricant in embedded in a permanent solid polymer
chain oils for conveyor belts. an application method that generates a
form that is not intended to undergo dust, mist or aerosol.
(iii) Hazard communication program. further processing except mechanical
A significant new use of the substance (iii) Disposal. Requirements as
processing. specified in § 721.85(a)(1) and (2), (b)(1)
is any manner or method of (2) The significant new uses are:
manufacture or processing associated and (2), and (c)(1) and (2).
(i) Protection in the workplace. (iv) Release to water. Requirements as
with any use of the substance without Requirements as specified in specified in § 721.90(a)(1), (b)(1), and
providing risk notification as follows: § 721.63(a)(1), (a)(2)(i) and (ii), (a)(3),
(A) If as a result of the test data (c)(1).
(4), and (6) (particulate), and (c). When (b) Specific requirements. The
required under the TSCA section 5(e) determining which persons are provisions of subpart A of this part
consent order for the substance, the reasonably likely to be exposed as apply to this section except as modified
employer becomes aware that the required for § 721.63(a)(1) and (4), by this paragraph (b).
substance may present a risk of injury engineering control measures (e.g., (1) Recordkeeping. Recordkeeping
to human health or the environment, the enclosure or confinement of the requirements as specified in
employer must incorporate this new operation, general and local ventilation) § 721.125(a) through (e) and (i) through
information, and any information on or administrative control measures (e.g., (k) are applicable to manufacturers and
methods for protecting against such risk, workplace policies and procedures) processors of this substance.
into a MSDS as described in § 721.72(c) shall be considered and implemented to (2) Limitations or revocation of
within 90 days from the time the prevent exposure, where feasible. The certain notification requirements. The
employer becomes aware of the new following National Institute for provisions of § 721.185 apply to this
information. If the substance is not Occupational Safety and Health section.
being manufactured, processed, or used (NIOSH)-certified respirators with an ■ 6. Add § 721.10998 to subpart E to
in the employer’s workplace, the APF of at least 50 meet the requirements read as follows:
employer must add the new information of § 721.63(a)(4):
to a MSDS before the substance is (A) A NIOSH-certified air-purifying, § 721.10998 Propanoic acid, iron (2+) salt
reintroduced into the workplace. tight-fitting full-face respirator equipped (2:1).
(B) The employer must ensure that with N–100, P–100, or R–100 cartridges. (a) Chemical substance and
persons who will receive the PMN (B) Any NIOSH-certified powered air- significant new uses subject to reporting.
substance from the employer, or who purifying respirator equipped with a (1) The chemical substance identified as
have received the PMN substance from tight-fitting full facepiece and equipped propanoic acid, iron (2+) salt (2:1) (CAS
the employer within 5 years from the with HEPA filters. #1952336–63–8) (PMN P–16–165) is
date the employer becomes aware of the (C) Any NIOSH-certified negative subject to reporting under this section
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new information described in paragraph pressure (demand) supplied-air for the significant new uses described in
(a)(2)(iii)(A) of this section, are provided respirator equipped with a full paragraph (a)(2) of this section.
an MSDS containing the information facepiece. (2) The significant new uses are:
required under paragraph (a)(2)(iii)(A) (ii) Industrial, commercial, and (i) Protection in the workplace.
of this section within 90 days from the consumer activities. Requirements as Requirements as specified in
time the employer becomes aware of the specified in § 721.80(k) (additives for § 721.63(a)(4) and (5) (particulate) and
new information. electro-static discharge in electronic (b) (concentration set at 1.0 percent).
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manufacture, process, or use the apply to this section except as modified ■ 12. Add § 721.11004 to subpart E to
substance other than as a blocked by this paragraph (b). read as follows:
catalyst for paints and coatings. It is a (1) Recordkeeping. Recordkeeping
requirements as specified in § 721.11004 Anilino substituted bis-
significant new use to spray apply the
triazinyl derivative of 4,4′-diaminostilbene-
PMN substance where the concentration § 721.125(a) through (i) are applicable to 2,2′-disulfonic acid, mixed amine sodium
of any combination of P–16–255, P–16– manufacturers and processors of this salt (generic).
256, P–16–257, P–16–258, and P–16– substance. (a) Chemical substance and
259 in the final paint/coating (2) Limitations or revocation of
significant new uses subject to reporting.
formulation exceeds 1.5% by weight. certain notification requirements. The
(1) The chemical substance identified
(b) Specific requirements. The provisions of § 721.185 apply to this
generically as anilino substituted bis-
provisions of subpart A of this part section.
triazinyl derivative of 4,4′-
apply to this section except as modified ■ 11. Add § 721.11003 to subpart E to diaminostilbene-2,2′-disulfonic acid,
by this paragraph (b). read as follows: mixed amine sodium salt (PMN P–16–
(1) Recordkeeping. Recordkeeping 284) is subject to reporting under this
requirements as specified in § 721.11003 1-Butanaminium, N,N,N-
tributyl-, and 1-methylethyl carbonate. section for the significant new uses
§ 721.125(a) through (i) are applicable to described in paragraph (a)(2) of this
manufacturers and processors of this (a) Chemical substance and
significant new uses subject to reporting. section.
substance. (2) The significant new uses are:
(2) Limitations or revocation of (1) The chemical substance identified as
(i) Industrial, commercial, and
certain notification requirements. The 1-butanaminium, N,N,N-tributyl-, and 1-
consumer activities. Requirements as
provisions of § 721.185 apply to this methylethyl carbonate (PMN P–16–259;
specified in § 721.80(f). It is a significant
section. CAS No. 1803407–49–9) is subject to
new use to import or use the substance
■ 10. Add § 721.11002 to subpart E to reporting under this section for the other than in a solution. It is a
read as follows: significant new uses described in significant new use to use the substance
paragraph (a)(2) of this section. other than as an optical brightener for
§ 721.11002 1-Butanaminium, N,N,N- (2) The significant new uses are:
textiles, paper, and paperboard. It is a
tributyl-, propyl carbonate (1:1). (i) Protection in the workplace.
significant new use to use the substance
(a) Chemical substance and Requirements as specified in
for non-industrial use or sell the
significant new uses subject to reporting. § 721.63(a)(1) and (3) and (b)
substance for ‘‘consumer use’’ or for
(1) The chemical substance identified as (concentration set at 1.0 percent).
(ii) Hazard communication. ‘‘commercial uses’’ (as the term is
1-butanaminium, N,N,N-tributyl-, defined at § 721.3) when the ‘‘saleable
propyl carbonate (1:1) (PMN P–16–258: Requirements as specified in § 721.72(a)
goods or service’’ could introduce the
CAS No. 1338579–13–7) is subject to through (e) (concentration set at 1.0
substance into a ‘‘consumer’’ setting (as
reporting under this section for the percent), (f), (g)(1)(i) and (ii), (g)(2)(i),
that term is defined in § 721.3). It is a
significant new uses described in (ii), (iii), and (v), (g)(3)(i) and (ii), (g)(4)
significant new use to use the substance
paragraph (a)(2) of this section. (Notice to users: Minimize release to
for an application method that generates
(2) The significant new uses are: water), and (g)(5). Alternative hazard
a dust, mist, or aerosol unless the
(i) Protection in the workplace. and warning statements that meet the
application method occurs in an
Requirements as specified in criteria of the Globally Harmonized
enclosed process.
§ 721.63(a)(1) and (3) and (b) System (GHS) and OSHA Hazard (ii) [Reserved].
(concentration set at 1.0 percent). Communication Standard may be used. (b) Specific requirements. The
(ii) Hazard communication. (iii) Industrial, commercial, and provisions of subpart A of this part
Requirements as specified in § 721.72(a) consumer activities. Requirements as apply to this section except as modified
through (e) (concentration set at 1.0 specified in § 721.80(p) (64,000 by this paragraph (b).
percent), (f), (g)(1)(i) and (ii), (g)(2)(i), kilograms aggregate of P–16–255, P–16– (1) Recordkeeping. Recordkeeping
(ii), (iii), and (v), (g)(3)(i) and (ii), and 256, P–16–257, P–16–258, and P–16– requirements as specified in
(g)(5) and Notice to users: Minimize 259). It is a significant new use to § 721.125(a) through (c) and (i) are
release to water. Alternative hazard and manufacture, process, or use the applicable to manufacturers and
warning statements that meet the substance other than as a blocked processors of this substance.
criteria of the Globally Harmonized catalyst for paints and coatings. It is a (2) Limitations or revocation of
System (GHS) and OSHA Hazard significant new use to spray apply the certain notification requirements. The
Communication Standard may be used. PMN substance where the concentration provisions of § 721.185 apply to this
(iii) Industrial, commercial, and of any combination of P–16–255, P–16– section.
consumer activities. Requirements as 256, P–16–257, P–16–258, and P–16– ■ 13. Add § 721.11005 to subpart E to
specified in § 721.80(p) (64,000 259 in the final paint/coating read as follows:
kilograms aggregate of P–16–255, P–16– formulation exceeds 1.5% by weight.
256, P–16–257, P–16–258, and P–16– (b) Specific requirements. The § 721.11005 12-Hydroxystearic acid,
259). It is a significant new use to provisions of subpart A of this part reaction products with alkylene diamine
manufacture, process, or use the apply to this section except as modified and alkanoic acid (generic).
substance other than as a blocked by this paragraph (b). (a) Chemical substance and
catalyst for paints and coatings. It is a (1) Recordkeeping. Recordkeeping significant new uses subject to reporting.
significant new use to spray apply the requirements as specified in (1) The chemical substances identified
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PMN substance where the concentration § 721.125(a) through (i) are applicable to generically as 12-Hydroxystearic acid,
of any combination of P–16–255, P–16– manufacturers and processors of this reaction products with alkylene diamine
256, P–16–257, P–16–258, and P–16– substance. and alkanoic acid (PMNs P–16–309 and
259 in the final paint/coating (2) Limitations or revocation of P–16–310) are subject to reporting under
formulation exceeds 1.5% by weight. certain notification requirements. The this section for the significant new uses
(b) Specific requirements. The provisions of § 721.185 apply to this described in paragraph (a)(2) of this
provisions of subpart A of this part section. section.
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(2) The significant new uses are: provisions of § 721.185 apply to this § 721.11008 Hydroxy functional
(i) Industrial, commercial, and section. triglyceride polymer with glycerol mono-
consumer activities. Requirements as ester and 1,1′-methylenebis[4-
■ 15. Add § 721.11007 to subpart E to isocyanatobenzene] (generic).
specified in § 721.80(f), (q), and (t). It is read as follows:
a significant new use to use the PMN (a) Chemical substances and
substance other than as a rheological or § 721.11007 Alkylaldehyde, reaction significant new uses subject to reporting.
thixotropic agent used in the production products with substituted carbomonocycle- (1) The chemical substance identified
of solvent based industrial coatings, substituted heteromonocycle-alkylene generically as hydroxy functional
high solid aromatic paints, adhesives, glycol triglyceride polymer with glycerol
sealants, and other types of paints and bis[[[[substituted(oxoneoalkyl)oxy]alkyl] mono-ester and 1,1′-methylenebis[4-
amino]alkyl] ether polymer and alkyl isocyanatobenzene] (PMN P–16–330) is
topcoats. substituted alkanediamine, acetate salts
(ii) Releases to water. Requirements as subject to reporting under this section
(generic).
specified in § 721.90(a)(4), (b)(4), and for the significant new uses described in
(c)(4) (N=2). (a) Chemical substance and paragraph (a)(2) of this section.
(b) Specific requirements. The significant new uses subject to reporting. (2) The significant new uses are:
provisions of subpart A of this part (1) The chemical substance identified (i) Protection in the workplace.
apply to this section except as modified generically as alkylaldehyde, reaction Requirements as specified in
by this paragraph (b). products with substituted § 721.63(a)(1), (a)(2)(i), (iii), and (iv),
(1) Recordkeeping. Recordkeeping carbomonocycle-substituted (a)(3), and (b) (concentration set at 0.1
requirements as specified in heteromonocycle-alkylene glycol percent)
§ 721.125(a) through (c), (i), and (k) are bis[[[[substituted(oxoneoalkyl)oxy]alkyl] (ii) Hazard communication.
applicable to manufacturers and amino]alkyl] ether polymer and alkyl Requirements as specified in § 721.72(a)
processors of this substance. substituted alkanediamine, acetate salts through (e) (concentration set at 1.0
(2) Limitations or revocation of (generic) (PMN P–16–323) is subject to percent), (f), (g)(1)(i) and (ii), (g)(2)(i),
certain notification requirements. The reporting under this section for the (ii), (iii), and (v), and (g)(5). Alternative
provisions of § 721.185 apply to this significant new uses described in hazard and warning statements that
section. paragraph (a)(2) of this section. meet the criteria of the Globally
(3) Determining whether a specific use (2) The significant new uses are: Harmonized System (GHS) and OSHA
is subject to this section. The provisions (i) Hazard communication. Hazard Communication Standard may
of § 721.1725(b)(1) apply to paragraph Requirements as specified in § 721.72(a) be used.
(a)(2)(ii) of this section. through (e) (concentration set at 0.1 (iii) Industrial, commercial, and
■ 14. Add § 721.11006 to subpart E to percent), (f), (g)(1) (respiratory tract consumer activities. Requirements as
read as follows: irritation), (g)(1)(i) and (vii), (g)(2)(i), (ii), specified in § 721.80. It is a significant
and (iii), (g)(3)(i) and (ii), and (g)(5). new use to manufacture the PMN
§ 721.11006 Alkyldiene, polymer, hydroxy substance to contain a residual of
terminated alkoxysilylalkylcarbamate. Alternative hazard and warning
statements that meet the criteria of the isocyanate greater than 0.1 weight
(a) Chemical substance and percent. It is a significant new use to
Globally Harmonized System (GHS) and
significant new uses subject to reporting. sell the substance for ‘‘consumer use’’ or
OSHA Hazard Communication Standard
(1) The chemical substance identified for ‘‘commercial uses’’ (as the term is
may be used.
generically as alkyldiene, polymer, defined at § 721.3) when the ‘‘saleable
hydroxy terminated (ii) Industrial, commercial, and
goods or service’’ could introduce the
alkoxysilylalkylcarbamate (PMN P–16– consumer activities. Requirements as
substance into a ‘‘consumer’’ setting (as
315) is subject to reporting under this specified in § 721.80(j). It is a significant
that term is defined in § 721.3).
section for the significant new uses new use to manufacture the PMN
(b) Specific requirements. The
described in paragraph (a)(2) of this substance to contain a residual of
provisions of subpart A of this part
section. formaldehyde greater than 0.1 weight
apply to this section except as modified
(2) The significant new uses are: percent. It is a significant new use to
by this paragraph (b).
(i) Industrial, commercial, and manufacture the substance in a manner
(1) Recordkeeping. Recordkeeping
consumer activities. Requirements as that results in inhalation exposure.
requirements as specified in
specified in § 721.80(f). It is a significant (b) Specific requirements. The § 721.125(a) through (i) are applicable to
new use to process the substance in a provisions of subpart A of this part manufacturers and processors of this
manner that results in inhalation apply to this section except as modified substance.
exposure. It is a significant new use to by this paragraph (b). (2) Limitations or revocation of
use the PMN substance other than as an (1) Recordkeeping. Recordkeeping certain notification requirements. The
additive to improve the compatibility requirements as specified in provisions of § 721.185 apply to this
and dispersibility of inorganic filler in § 721.125(a) through (c), (f), (g), and (h) section.
industrial rubber formulations. are applicable to manufacturers and ■ 17. Add § 721.11009 to subpart E to
(ii) [Reserved]. processors of this substance. read as follows:
(b) Specific requirements. The (2) Limitations or revocation of
provisions of subpart A of this part certain notification requirements. The § 721.11009 Hydroxy functional
apply to this section except as modified provisions of § 721.185 apply to this triglyceride polymer with glycerol mono-
by this paragraph (b). section. ester and 1,1′-
rmajette on DSKBCKNHB2PROD with RULES
(1) Recordkeeping. Recordkeeping methylenebis[isocyanatobenzene]
requirements as specified in (3) Determining whether a specific use (generic).
§ 721.125(a) through (c) and (i) are is subject to this section. The provisions (a) Chemical substances and
applicable to manufacturers and of § 721.1725(b)(1) apply to paragraph significant new uses subject to reporting.
processors of this substance. (a)(2)(ii) of this section. (1) The chemical substance identified
(2) Limitations or revocation of ■ 16. Add § 721.11008 to subpart E to generically as hydroxy functional
certain notification requirements. The read as follows: triglyceride polymer with glycerol
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mono-ester and 1,1′- substance such that more than 33% ■ 20. Add § 721.11012 to subpart E to
methylenebis[isocyanatobenzene] (PMN contains 10 or more repeating ethylene read as follows:
P–16–331) is subject to reporting under oxide units.
§ 721.11012 Alkyl carbonate, polymer with,
this section for the significant new uses (ii) [Reserved]. substituted alkanes and substituted
described in paragraph (a)(2) of this (b) Specific requirements. The heteromonocycle, substituted alkyl
section. provisions of subpart A of this part acrylate-blocked (generic).
(2) The significant new uses are: apply to this section except as modified (a) Chemical substance and
(i) Protection in the workplace. by this paragraph (b). significant new uses subject to reporting.
Requirements as specified in (1) Recordkeeping. Recordkeeping (1) The chemical substance identified
§ 721.63(a)(1), (a)(2)(i), (iii), and (iv), requirements as specified in generically as alkyl carbonate, polymer
(a)(3), and (b) (concentration set at 0.1 § 721.125(a) through (c) and (i) are with, substituted alkanes and
percent). applicable to manufacturers and substituted heteromonocycle,
(ii) Hazard communication. processors of this substance. substituted alkyl acrylate-blocked
Requirements as specified in § 721.72(a) (2) Limitations or revocation of (generic) (PMN P–16–365) is subject to
through (e) (concentration set at 1.0 certain notification requirements. The reporting under this section for the
percent), (f), (g)(1)(i) and (ii), (g)(2)(i), provisions of § 721.185 apply to this significant new uses described in
(ii), (iii), and (v), and (g)(5). Alternative section. paragraph (a)(2) of this section.
hazard and warning statements that (2) The significant new uses are:
■ 19. Add § 721.11011 to subpart E to
meet the criteria of the Globally (i) Protection in the workplace.
read as follows:
Harmonized System (GHS) and OSHA Requirements as specified in
Hazard Communication Standard may § 721.11011 Pulp, cellulose, reaction § 721.63(a)(1) and (3) and (b)
be used. products with lignin. (concentration set at 0.1 percent).
(iii) Industrial, commercial, and (a) Chemical substance and (ii) Hazard communication.
consumer activities. Requirements as significant new uses subject to reporting. Requirements as specified in § 721.72(a)
specified in § 721.80. It is a significant (1) The chemical substance identified through (e) (concentration set at 0.1
new use to manufacture the PMN generically as pulp, cellulose, reaction percent), (f), (g)(1) (lung effects), (g)(1)
substance to contain a residual of products with lignin (PMN P–16–361; (sensitization), (g)(1)(vii), (g)(2)(i), (ii),
isocyanate greater than 0.1 weight CAS No. 167062–70–6) is subject to (iii), and (v), and (g)(5).
percent. It is a significant new use to reporting under this section for the (iii) Industrial, commercial, and
sell the substance for ‘‘consumer use’’ or significant new uses described in consumer activities. Requirements as
for ‘‘commercial uses’’ (as the term is paragraph (a)(2) of this section. The specified in § 721.80. It is a significant
defined at § 721.3) when the ‘‘saleable requirements of this section do not new use to manufacture the substance to
goods or service’’ could introduce the apply to quantities of the PMN contain a residual of isocyanate greater
substance into a ‘‘consumer’’ setting (as substance after they have been than 0.1 weight percent. It is a
that term is defined in § 721.3). incorporated into a polymer matrix. significant new use to sell the substance
(b) Specific requirements. The (2) The significant new uses are: for ‘‘consumer use’’ or for ‘‘commercial
provisions of subpart A of this part (i) Industrial, commercial, and uses’’ (as the term is defined at § 721.3)
apply to this section except as modified consumer activities. Requirements as when the ‘‘saleable goods or service’’
by this paragraph (b). specified in § 721.80(y)(1). It is a could introduce the substance into a
(1) Recordkeeping. Recordkeeping ‘‘consumer’’ setting (as that term is
significant new use to manufacture,
requirements as specified in defined in § 721.3).
process, or use the PMN substance other
§ 721.125(a) through (i) are applicable to (b) Specific requirements. The
than in a liquid or gel formulation,
manufacturers and processors of this provisions of subpart A of this part
unless the solid particle form has a
substance. apply to this section except as modified
particle size distribution where less
(2) Limitations or revocation of by this paragraph (b).
than 0.5% of the particles are less than
certain notification requirements. The (1) Recordkeeping. Recordkeeping
10 microns. It is a significant new use
provisions of § 721.185 apply to this requirements as specified in
to manufacture the solid particle form
section. § 721.125(a) through (i) are applicable to
more than six months without
■ 18. Add § 721.11010 to subpart E to manufacturers and processors of this
measuring the particle size distribution
read as follows: to characterize the particle size substance.
distribution of fractions less than 10 (2) Limitations or revocation of
§ 721.11010 Poly(oxy-1,2-
microns of the dry particle PMN certain notification requirements. The
ethanediyl),.alpha.-(1-oxodocosyl)-.omega.-
[(1-oxodocosyl)oxy]- substance and sending the results of the provisions of § 721.185 apply to this
measurement to EPA. section.
(a) Chemical substance and
(ii) [Reserved]. ■ 21. Add § 721.11013 to subpart E to
significant new uses subject to reporting.
(1) The chemical substance identified (b) Specific requirements. The read as follows:
generically as poly(oxy-1,2- provisions of subpart A of this part § 721.11013 Substituted heteromonocycle,
ethanediyl),.alpha.-(1-oxodocosyl)- apply to this section except as modified polymer with substituted alkane and
.omega.-[(1-oxodocosyl)oxy]- (PMN P– by this paragraph (b). ethoxylated alkane, substituted
16–360; CAS No. 36493–27–3) is subject (1) Recordkeeping. Recordkeeping heteromonocycle substituted alkyl ester-
to reporting under this section for the requirements as specified in blocked (generic).
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significant new uses described in § 721.125(a) through (c) and (i) are (a) Chemical substance and
paragraph (a)(2) of this section. applicable to manufacturers and significant new uses subject to reporting.
(2) The significant new uses are: processors of this substance. (1) The chemical substance identified
(i) Industrial, commercial, and (2) Limitations or revocation of generically as substituted
consumer activities. Requirements as certain notification requirements. The heteromonocycle, polymer with
specified in § 721.80. It is a significant provisions of § 721.185 apply to this substituted alkane and ethoxylated
new use to manufacture the PMN section. alkane, substituted heteromonocycle
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![48654 Federal Register / Vol. 82, No. 201 / Thursday, October 19, 2017 / Rules and Regulations
OSHA Hazard Communication Standard provisions listed in the TSCA section specified in § 721.80(g). It is a
may be used. 5(e) consent order for this substance. significant new use to manufacture the
(iii) Industrial, commercial, and The NCEL is 0.3 mg/m3 as an 8-hour substance to have an average molecular
consumer activities. Requirements as time weighted average verified by actual weight less than 1500 daltons. It is a
specified in § 721.80(j) and (q). monitoring data. significant new use to manufacture the
(b) Specific requirements. The (2) [Reserved]. substance to have more than 24% by
provisions of subpart A of this part (ii) Hazard communication. weight of the acid component identified
apply to this section except as modified Requirements as specified in § 721.72(a) in the 5(e) consent order.
by this paragraph (b). through (e) (concentration set at 0.1 (ii) [Reserved].
(1) Recordkeeping. Recordkeeping percent), (f), (g)(1) (lung effects), (b) Specific requirements. The
requirements as specified in (g)(1)(vii), (g)(2)(ii), (iii), and (iv), provisions of subpart A of this part
§ 721.125(a) through (i) are applicable to (g)(3)(ii), (g)(4)(i) and (iii), and (g)(5). apply to this section except as modified
manufacturers and processors of this (iii) Industrial, commercial, and by this paragraph (b).
substance. consumer activities. Requirements as
(2) Limitations or revocation of (1) Recordkeeping. Recordkeeping
specified in § 721.80(q). It is a requirements as specified in
certain notification requirements. The significant new use to use the PMN
provisions of § 721.185 apply to this § 721.125(a) through (c) and (i) are
substance other than as a component of applicable to manufacturers and
section. infrared absorption material. It is a
(3) Determining whether a specific use processors of this substance.
significant new use for any application
is subject to this section. The provisions method that generates a dust, mist, or (2) Limitations or revocation of
of § 721.1725(b)(1) apply to paragraph aerosol, unless such application method certain notification requirements. The
(a)(2)(ii) of this section. occurs in an enclosed process. provisions of § 721.185 apply to this
■ 25. Add § 721.11017 to subpart E to (iv) Disposal. Requirements as section.
read as follows: specified in § 721.85(a)(1) and (2), (b)(1) (3) Determining whether a specific use
and (2), and (c)(1) and (2). is subject to this section. The provisions
§ 721.11017 Sodium tungsten oxide. (v) Releases to water. Requirements as of § 721.1725(b)(1) apply to paragraph
(a) Chemical substance and specified in § 721.90(a)(1), (b)(1), and (a)(2)(ii) of this section.
significant new uses subject to reporting. (c)(1). ■ 27. Add § 721.11019 to subpart E to
(1) The chemical substance identified as (b) Specific requirements. The read as follows:
sodium tungsten oxide (PMN P–16–455) provisions of subpart A of this part
is subject to reporting under this section apply to this section except as modified § 721.11019 Alkyl bisphenol (generic).
for the significant new uses described in by this paragraph (b). (a) Chemical substance and
paragraph (a)(2) of this section. The (1) Recordkeeping. Recordkeeping significant new uses subject to reporting.
requirements of this section do not requirements as specified in (1) The chemical substance identified
apply to quantities of the substance that § 721.125(a) through (k) are applicable generically as alkyl bisphenol (PMN P–
have been incorporated into a polymer to manufacturers and processors of this 16–591) is subject to reporting under
matrix. substance. this section for the significant new uses
(2) The significant new uses are: (2) Limitations or revocation of described in paragraph (a)(2) of this
(i) Protection in the workplace. certain notification requirements. The section.
Requirements as specified in provisions of § 721.185 apply to this (2) The significant new uses are:
§ 721.63(a)(1), (3), (4), and (6) section. (i) Protection in the workplace.
(particulate). The following National (3) Determining whether a specific use Requirements as specified in
Institute for Occupational Safety and is subject to this section. The provisions § 721.63(a)(1), (a)(2)(i), (ii), and (iv),
Health (NIOSH)-certified respirators of § 721.1725(b)(1) apply to paragraph (a)(3) and (4), (a)(6)(v) and (vi), (a)(6)
with an APF of at least 1000 meet the (a)(2)(ii) of this section. (particulate), and (b) (concentration set
requirements of § 721.63(a)(4): ■ 26. Add § 721.11018 to subpart E to at 1.0 percent). When determining
(A) Any NIOSH-certified powered air read as follows: which persons are reasonably likely to
purifying full facepiece respirator
be exposed as required for
equipped with appropriate gas/vapor § 721.11018 Fatty acids, tall-oil, polymers
with alkanoic acid, substituted § 721.63(a)(4), engineering control
(acid gas, organic vapor, or substance
carbomonocycle, alkyl peroxide-initiated measures (e.g., enclosure or
specific) cartridges.
(B) Any NIOSH-certified continuous (generic). confinement of the operation, general
flow supplied-air respirator equipped (a) Chemical substance and and local ventilation) or administrative
with a full facepiece. significant new uses subject to reporting. control measures (e.g., workplace
(C) Any NIOSH-certified pressure- (1) The chemical substance identified policies and procedures) shall be
demand or other positive pressure mode generically as fatty acids, tall-oil, considered and implemented to prevent
supplied-air respirator equipped with a polymers with alkanoic acid, exposure, where feasible. The following
full facepiece. substituted carbomonocycle, alkyl National Institute for Occupational
(D) Any NIOSH-certified continuous peroxide-initiated (PMN P–16–503) is Safety and Health (NIOSH)-certified
flow supplied-air respirator equipped subject to reporting under this section respirators with an APF of at least 10
with a full facepiece. for the significant new uses described in meet the requirements of § 721.63(a)(4):
(E) Any NIOSH-certified pressure- paragraph (a)(2) of this section. The (A) NIOSH-certified respirator with an
rmajette on DSKBCKNHB2PROD with RULES
demand or other positive pressure mode requirements of this section do not N–100, P–100, or R–100 cartridge.
supplied-air respirator equipped with a apply to quantities of the PMN (B) NIOSH-certified power air
full facepiece. substance that have been completely purifying respirator with a hood or
(1) As an alternative to the respiratory reacted (cured). helmet and with appropriate gas/vapor
requirements listed here, a manufacturer (2) The significant new uses are: (acid gas, organic vapor, or substance
or processor may choose to follow the (i) Industrial, commercial, and specific) cartridges in combination with
New Chemical Exposure Limit (NCEL) consumer activities. Requirements as HEPA filters.
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![Federal Register / Vol. 82, No. 201 / Thursday, October 19, 2017 / Rules and Regulations 48655
(C) NIOSH-certified continuous flow (PHMSA) is announcing an additional interim final rule (IFR) titled: ‘‘Pipeline
supplied-air respirator equipped with a opportunity for the public to comment Safety: Underground Natural Gas
loose fitting facepiece, hood, or helmet. on an interim final rule (IFR) titled: Storage Facilities’’ (81 FR 91860). In the
(ii) Hazard communication. ‘‘Pipeline Safety: Underground Natural IFR, PHMSA established minimum
Requirements as specified in § 721.72(a) Gas Storage Facilities.’’ PHMSA is federal safety standards for intrastate
through (e) (concentration set at 0.1 reopening the comment period in and interstate underground natural gas
percent), (f), (g)(1) (dermal response to a petition for storage facilities under its regulatory
sensitization), (g)(1) (endocrine reconsideration filed jointly by the authority at 49 U.S.C. 60101 and 60102
disruption), (g)(1) (reproductive effects), American Gas Association, American and as directed by section 12 of the
(g)(1)(i), (ii), (iv), and (ix), (g)(2)(i), (ii), Petroleum Institute, and the American ‘‘Protecting our Infrastructure of
(iii), (iv), and (v), (g)(3)(i) and (ii), Public Gas Association. By reopening
(g)(4)(iii), and (g)(5). Alternative hazard Pipelines and Enhancing Safety Act of
the comment period, PHMSA is 2016.’’ On January 18, 2017, the
and warning statements that meet the providing all interested parties with the
criteria of the Globally Harmonized American Gas Association, the
opportunity to comment on the IFR and
System (GHS) and OSHA Hazard American Petroleum Institute, the
the merits and claims of the petition.
Communication Standard may be used. PHMSA will consider all public American Public Gas Association, and
(iii) Industrial, commercial, and comments and address the petition for the Interstate Natural Gas Association of
consumer activities. Requirements as reconsideration in the final rule. America (INGAA) jointly submitted a
specified in § 721.80(q). It is a DATES: The comment period for the
petition seeking reconsideration of
significant new use to use the PMN certain provisions of the IFR. (INGAA
interim final rule published on
substance in thermal paper printing has since withdrawn from the petition.)
December 19, 2016 (81 FR 91860), is
(iv) Releases to water. Requirements
reopened. Comments must be received Recognizing that the IFR set certain
as specified in § 721.90(a)(1), (b)(1), and
(c)(1). by November 20, 2017. deadlines by which the operators of
(b) Specific requirements. The ADDRESSES: You may submit comments underground natural gas storage
provisions of subpart A of this part identified by the docket number facilities must act but that would occur
apply to this section except as modified PHMSA–2016–0016 by any of the before PHMSA could adopt a final rule,
by this paragraph (b). following methods: PHMSA published a notice on June 20,
(1) Recordkeeping. Recordkeeping • Federal eRulemaking Portal: http:// 2017, in the Federal Register (82 FR
requirements as specified in www.regulations.gov. Follow the online 28224), announcing that (1) the agency
§ 721.125(a) through (i) and (k) are instructions for submitting comments. would not issue enforcement citations
applicable to manufacturers and • Fax: 1–202–493–2251. to operators for non-compliance with
processors of this substance. • Mail: Hand Delivery: U.S. DOT
certain provisions of the IFR for a period
(2) Limitations or revocation of Docket Management System, West
of one year after publication of the final
certain notification requirements. The Building Ground Floor, Room W12–140,
1200 New Jersey Avenue SE., rule, and (2) it intended to address the
provisions of § 721.185 apply to this issues raised by the petitioners in the
section. Washington, DC 20590–0001 between
9:00 a.m. and 5:00 p.m., Monday final rule. For these reasons, PHMSA is
(3) Determining whether a specific use
through Friday, except Federal holidays. now providing the public with an
is subject to this section. The provisions
Instructions: If you submit your additional opportunity to comment on
of § 721.1725(b)(1) apply to paragraph
comments by mail, submit two copies. the IFR and an opportunity to comment
(a)(2)(ii) of this section.
To receive confirmation that PHMSA on the issues raised in the petition.
Editorial note: This document was received your comments, include a self- PHMSA is therefore reopening the
received for publication by the Office of the
Federal Register on October 10, 2017. addressed stamped postcard. comment period for this IFR until
Note: Comments are posted without November 20, 2017. All documents and
[FR Doc. 2017–22239 Filed 10–18–17; 8:45 am]
changes or edits to http:// comments related to this matter are
BILLING CODE 6560–50–P
www.regulations.gov, including any personal available for review at http://
information provided. There is a privacy www.regulations.gov in docket number
statement published on http:// PHMSA–2016–0016.
DEPARTMENT OF TRANSPORTATION www.regulations.gov.
Issued in Washington, DC, on October 11,
Pipeline and Hazardous Materials Privacy Act Statement 2017, under authority delegated in 49 CFR
Safety Administration 1.97.
In accordance with 5 U.S.C. 553(c),
DOT solicits comments from the public Alan K. Mayberry,
49 CFR Parts 191 and 192 Associate Administrator for Pipeline Safety.
to better inform its rulemaking process.
[Docket No. PHMSA–2016–0016; Amdt. Nos. DOT posts these comments, without [FR Doc. 2017–22553 Filed 10–18–17; 8:45 am]
191–24; 192–122] edit, including any personal information BILLING CODE 4910–60–P
RIN 2137–AF22 the commenter provides, to
www.regulations.gov, as described in
Pipeline Safety: Safety of Underground the system of records notice (DOT/ALL–
Natural Gas Storage Facilities 14 FDMS), which can be reviewed at
www.dot.gov/privacy.
AGENCY: Pipeline and Hazardous
rmajette on DSKBCKNHB2PROD with RULES
FOR FURTHER INFORMATION CONTACT:
Materials Safety Administration
(PHMSA); DOT. Byron Coy, Senior Technical Advisor,
Pipeline Safety Policy and Programs, by
ACTION: Interim final rule; reopening
telephone at 609–771–7810 or by email
comment period.
at byron.coy@dot.gov.
SUMMARY: The Pipeline and Hazardous SUPPLEMENTARY INFORMATION: In
Materials Safety Administration December 2016, PHMSA issued an
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Document Created: 2017-10-19 02:56:36
Document Modified: 2017-10-19 02:56:36
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Direct final rule. | |
| Dates | This rule is effective on December 18, 2017. For purposes of judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on November 2, 2017. | |
| 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 | |
| FR Citation | 82 FR 48637 | |
| 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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